[Federal Register Volume 60, Number 13 (Friday, January 20, 1995)]
[Notices]
[Pages 4238-4302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-992]
[[Page 4237]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
National Institutes of Health
_______________________________________________________________________
Privacy Act of 1974; Annual Publication of Systems of Records; Notice
Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 /
Notices
[[Page 4238]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Privacy Act of 1974; Annual Publication of Systems of Records
AGENCY: Public Health Service, DHHS.
ACTION: Privacy Act: Annual republication of notices of revised systems
of records.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health (NIH) has conducted a
comprehensive review of all Privacy Act systems of records and is
publishing the resulting revisions. None of the revisions meet the OMB
criteria for a new or altered system of records requiring an advance
period for public comment. These changes are in compliance with
Circular A-130, Appendix 1. The notices republished below are complete
and accurate as of January 5, 1995.
SUPPLEMENTARY INFORMATION:
The following information summarizes the current status of systems
of records which had minor modifications during 1994 and lists all
systems maintained by NIH:
A. System name. The following systems have been updated to reflect
a change in the name of the system:
09-25-0093, Administration: Administration Authors, Reviewers and
Members of the Journal of the National Cancer Institute, HHS/NIH/
NCI.
09-25-0105, Administration: Health Records of Employees, Visiting
Scientists, Fellows, Contractors and Others who Receive Medical Care
Through the Employee Health Unit, HHS/NIH/ORS.
09-25-0165, National Institutes of Health Loan Repayment Program,
HHS/NIH/OD.
09-25-0166, Administration: Radiation and Occupational Safety and
Health Management Information System, HHS/NIH/ORS.
09-25-0170, Diabetes Control and Complications Trial (DCCT) Data
System, HHS/NIH/NIDDK.
09-25-0203, National Institute on Drug Abuse, Addiction Research
Center, Federal Prisoner and Non-Prisoner Research Files, HHS/NIH/
NIDA.
09-25-0207, Subject--Participants in Pharmacokinetic Studies on
Drugs of Abuse and on Treatment Medications, HHS/NIH/NIDA.
09-25-0209, Subject--Participants in Drug Abuse Research Studies on
Drug Dependence and in Research Supporting New Drug Applications,
HHS/NIH/NIDA.
B. System location. The following systems have been updated to
reflect a change in the system locations or location address. These
changes do not affect the access by the individual to the individual's
records.
09-25-0011, Clinical Research: Blood Donor Records, HHS/NIH/CC.
09-25-0012, Clinical Research: Candidate Normal Volunteer Records,
HHS/NIH/CC.
09-25-0014, Clinical Research: Student Records, HHS/NIH/CC.
09-25-0042, Clinical Research: National Institute of Dental Research
Patient Records, HHS/NIH/NIDR.
09-25-0044, Clinical Research: Sensory Testing Research Program,
HHS/NIH/NIDR.
09-25-0054, Administration: Property Accounting, HHS/NIH/ORS.
09-25-0099, Clinical Research: Patient Medical Records, HHS/NIH/CC.
09-25-0102, Administration: Grants Associates Program Working Files,
HHS/NIH/OER.
09-25-0112, Grants and Cooperative Agreements: Research, Research
Training, Fellowship and Construction Applications and Related
Awards, HHS/NIH/OD.
09-25-0118, Contracts: Professional Services Contractors, HHS/NIH/
NCI.
09-25-0154, Biomedical Research Records of Subjects: (1) Cancer
Studies of the Division of Cancer Prevention and Control, HHS/NIH/
NCI; and (2) Women's Health Initiative (WHI) Studies, HHS/NIH/OD.
09-25-0165, National Institutes of Health Loan Repayment Program,
HHS/NIH/OD.
09-25-0166, Administration: Radiation and Occupational Safety and
Health Management Information System, HHS/NIH/ORS.
09-25-0168, Invention, Patent and Licensing Documents Submitted to
the Public Health Service by its Employees, Grantees, Fellowship
Recipients and Contractors, HHS/PHS/NIH/OTT.
09-25-0170, Diabetes Control and Complications Trial (DCCT) Data
System, HHS/NIH/NIDDK.
09-25-0202, Patient Records on PHS Beneficiaries (1935-1974) and
Civilly Committed Drug Abusers (1967-1976) Treated at the PHS
Hospitals in Fort Worth, Texas, or Lexington, Kentucky, HHS/NIH/
NIDA.
09-25-0203, National Institute on Drug Abuse, Addiction Research
Center, Federal Prisoner and Non-Prisoner Research Files, HHS/NIH/
NIDA.
09-25-0209, Subject--Participants in Drug Abuse Research Studies on
Drug Dependence and in Research Supporting New Drug Applications,
HHS/NIH/NIDA.
C. Categories of individuals covered by the system. The following
systems have been updated to reflect a change in the categories covered
by the system. This change does not alter the character or purpose of
the system.
09-25-0105, Administration: Health Records of Employees, Visiting
Scientists, Fellows, Contractors and Others who Receive Medical Care
Through the Employee Health Unit, HHS/NIH/ORS.
09-25-0154, Biomedical Research Records of Subjects: (1) Cancer
Studies of the Division of Cancer Prevention and Control, HHS/NIH/
NCI; and (2) Women's Health Initiative (WHI) Studies, HHS/NIH/OD.
09-25-0165, National Institutes of Health Loan Repayment Program,
HHS/NIH/OD.
09-25-0166, Administration: Radiation and Occupational Safety and
Health Management Information System, HHS/NIH/ORS.
09-25-0170, Diabetes Control and Complications Trial (DCCT) Data
System, HHS/NIH/NIDDK.
09-25-0207, Subject-Participants in Pharmacokinetic Studies on Drugs
of Abuse and on Treatment Medications, HHS/NIH/NIDA.
D. Categories of records. The following systems have been updated
to reflect a change in the categories of records in the system. This
change does not alter the character or purpose of the system.
09-25-0166, Administration: Radiation and Occupational Safety and
Health Management Information System, HHS/NIH/ORS.
09-25-0170, Diabetes Control and Complications Trial (DCCT) Data
System, HHS/NIH/NIDDK.
E. Authority. The following system has been updated to reflect a
change in the authority. This change does not alter the character or
purpose of the system.
09-25-0165, National Institutes of Health Loan Repayment Program,
HHS/NIH/OD.
F. Storage. The following systems have been updated to reflect a
change in system storage practices:
09-25-0026, Clinical Research: Nervous System Studies, HHS/NIH/
NINDS.
09-25-0028, Clinical Research: Patient Medical Histories, HHS/NIH/
NINDS and HHS/NIH/NIDCD.
09-25-0077, Biological Carcinogenesis Branch Human Specimen Program,
HHS/NIH/NCI.
09-25-0140, International Activities: International Scientific
Researchers in Intramural Laboratories at the National Institutes of
Health, HHS/NIH/FIC.
09-25-0166, Administration: Radiation and Occupational Safety and
Health Management Information System, HHS/NIH/ORS.
09-25-0209, Subject-Participants in Drug Abuse Research Studies on
Drug Dependence and in Research Supporting New Drug Applications,
HHS/NIH/NIDA.
G. Retrieval. The following systems have been updated to reflect a
change in retrieval practices.
09-25-0140, International Activities: International Scientific
Researchers in Intramural Laboratories at the National Institutes of
Health, HHS/NIH/FIC.
09-25-0142, Clinical Research: Records of Subjects in Intramural
Research, Epidemiology, Demography and Biometry Studies on Aging,
HHS/NIH/NIA.
09-25-0203, National Institute on Drug Abuse, Addiction Research
Center, Federal Prisoner and Non-Prisoner Research Files, HHS/NIH/
NIDA.
09-25-0209, Subject-Participants in Drug Abuse Research Studies on
Drug [[Page 4239]] Dependence and in Research Supporting New Drug
Applications, HHS/NIH/NIDA.
H. Safeguards. The following systems have been updated to reflect a
change in safeguard practices.
09-25-0028, Clinical Research: Patient Medical Histories, HHS/NIH/
NINDS and HHS/NIH/NIDCD.
09-25-0093, Administration: Administration Authors, Reviewers and
Members of the Journal of the National Cancer Institute, HHS/NIH/
NCI.
09-25-0166, Administration: Radiation and Occupational Safety and
Health Management Information System, HHS/NIH/ORS.
09-25-0207, Subject-Participants in Pharmacokinetic Studies on Drugs
of Abuse and on Treatment Medications, HHS/NIH/NIDA.
09-25-0209, Subject-Participants in Drug Abuse Research Studies on
Drug Dependence and in Research Supporting New Drug Applications,
HHS/NIH/NIDA.
I. Retention and disposal. The following systems have been updated
to reflect a change in retention and disposal:
09-25-0152, Biomedical Research: Records of Subjects in National
Institute of Dental Research Contracted Epidemiological and
Biometric Studies, HHS/NIH/NIDR.
09-25-0207, Subject-Participants in Pharmacokinetic Studies on Drugs
of Abuse and on Treatment Medications, HHS/NIH/NIDA.
09-25-0209, Subject-Participants in Drug Abuse Research Studies on
Drug Dependence and in Research Supporting New Drug Applications,
HHS/NIH/NIDA.
09-25-0212, Clinical Research: Neuroscience Research Center Patient
Medical Records, HHS/NIH/NIMH.
J. System manager(s) and address(es). The following systems have
been updated to reflect a change in the system manager or the address
of the system manager. These changes do not affect the access by the
individual to the individual's records.
09-25-0001, Clinical Research: Patient Records, HHS/NIH/NHLBI.
09-25-0005, Administration: Library Operations and User I.D. File,
HHS/NIH/OD.
09-25-0011, Clinical Research: Blood Donor Records, HHS/NIH/CC.
09-25-0012, Clinical Research: Candidate Normal Volunteer Records,
HHS/NIH/CC.
09-25-0014, Clinical Research: Student Records, HHS/NIH/CC.
09-25-0026, Clinical Research: Nervous System Studies, HHS/NIH/
NINDs.
09-25-0028, Clinical Research: Patient Medical Histories, HHS/NIH/
NINDS and HHS/NIH/NIDCD.
09-25-0042, Clinical Research: National Institute of Dental Research
Patient Records, HHS/NIH/NIDR.
09-25-0044, Clinical Research: Sensory Testing Research Program,
HHS/NIH/NIDR.
09-25-0054, Administration: Property Accounting, HHS/NIH/ORS.
09-25-0078, Administration: Consultant File, HHS/NIH/NHLBI.
09-25-0093, Administration: Administration Authors, Reviewers and
Members of the Journal of the National Cancer Institute, HHS/NIH/
NCI.
09-25-0099, Clinical Research: Patient Medical Records, HHS/NIH/CC.
09-25-0102, Administration: Grants Associates Program Working Files,
HHS/NIH/OER.
09-25-0106, Administration: Office of the NIH Director and
Institute/Center/Division Correspondence Records, HHS/NIH/OD.
09-25-0112, Grants and Cooperative Agreements: Research, Research
Training, Fellowship and Construction Applications and Related
Awards, HHS/NIH/OD.
09-25-0118, Contracts: Professional Services Contractors, HHS/NIH/
NCI.
09-25-0126, Clinical Research: National Heart, Lung, and Blood
Institute Epidemiological and Biometric Studies, HHS/NIH/NHLBI.
09-25-0128, Clinical Research: Neural Prosthesis and Biomedical
Engineering Studies, HHS/NIH/NINDS.
09-25-0129, Clinical Research: Clinical Research Studies Dealing
with Hearing, Speech, Language and Chemosensory Disorders, HHS/NIH/
NIDCD.
09-25-0140, International Activities: International Scientific
Researchers in Intramural Laboratories at the National Institutes of
Health, HHS/NIH/FIC.
09-25-0148, Contracted and Contract-Related Research: Records of
Subjects in Clinical, Epidemiological and Biomedical Studies of the
National Institute of Neurological Disorders and Stroke and the
National Institute on Deafness and Other Communication Disorders,
HHS/NIH/NINDS and HHS/NIH/NIDCD.
09-25-0152, Biomedical Research: Records of Subjects in National
Institute of Dental Research Contracted Epidemiological and
Biometric Studies, HHS/NIH/NIDR.
09-25-0153, Biomedical Research: Records of Subjects in Biomedical
and Behavioral Studies of Child Health and Human Development, HHS/
NIH/NICHD.
09-25-0154, Biomedical Research Records of Subjects: (1) Cancer
Studies of the Division of Cancer Prevention and Control, HHS/NIH/
NCI; and (2) Women's Health Initiative (WHI), Studies, HHS/NIH/OD.
09-25-0156, Records of Participants in Programs and Respondents in
Surveys Used to Evaluate Programs of the Public Health Service, HHS/
PHS/NIH/OD.
09-25-0161, Administration: NIH Consultant File, HHS/NIH/DRG.
09-25-0166, Administration: Radiation and Occupational Safety and
Health Management Information System, HHS/NIH/ORS.
09-25-0168, Invention, Patent and Licensing Documents Submitted to
the Public Health Service by its Employees, Grantees, Fellowship
Recipients and Contractors, HHS/PHS/NIH/OTT.
09-25-0170, Diabetes Control and Complications Trial (DCCT) Data
System, HHS/NIH/NIDDK.
09-25-0202, Patient Records on PHS Beneficiaries (1935-1974) and
Civilly Committed Drug Abusers (1967-1976) Treated at the PHS
Hospitals in Fort Worth, Texas, or Lexington, Kentucky, HHS/NIH/
NIDA.
09-25-0203, National Institute on Drug Abuse, Addiction Research
Center, Federal Prisoner and Non-Prisoner Research Files, HHS/NIH/
NIDA.
09-25-0205, Alcohol, Drug Abuse, and Mental Health Epidemiologic and
Biometric Research Data, HHS/NIH/NIAAA, HHS/NIH/NIDA and HHS/NIH/
NIMH.
09-25-0208, Drug Abuse Treatment Outcome Study (DATOS), HHS/NIH/
NIDA.
K. Record access. The following systems have been updated to
reflect a change in the record access procedures.
09-25-0012, Clinical Research: Candidate Normal Volunteer Records,
HHS/NIH/CC.
09-25-0156, Records of Participants in Programs and Respondents in
Surveys Used to Evaluate Programs of the Public Health Service, HHS/
PHS/NIH/OD.
L. Notification procedures. The following systems have been updated
to reflect a change in the office, official, and/or address to write to
in order to determine whether or not the system contains a record about
the individual.
09-25-0042, Clinical Research: National Institute of Dental Research
Patient Records, HHS/NIH/NIDR.
09-25-0044, Clinical Research: Sensory Testing Research Program,
HHS/NIH/NIDR.
09-25-0078, Administration: Consultant File, HHS/NIH/NHLBI.
09-25-0112, Grants and Cooperative Agreements: Research, Research
Training, Fellowship and Construction Applications and Related
Awards, HHS/NIH/OD.
09-25-0152, Biomedical Research: Records of Subjects in National
Institute of Dental Research Contracted Epidemiological and
Biometric Studies, HHS/NIH/NIDR.
09-25-0153, Biomedical Research: Records of Subjects in Biomedical
and Behavioral Studies of Child Health and Human Development, HHS/
NIH/NICHD.
09-25-0156, Records of Participants in Programs and Respondents in
Surveys Used To Evaluate Programs of the Public Health Service, HHS/
PHS/NIH/OD.
M. The following systems have been changed for clarity and editing
purposes.
09-25-0036, Extramural Awards and Chartered Advisory Committees:
IMPAC (Grant/Contract/Cooperative Agreement/Chartered Advisory
Committee, HHS/NIH/DRG and HHS/NIH/CMO.
09-25-0093, Administration: Administration Authors, Reviewers and
Members of the Journal of the National Cancer Institute, HHS/NIH/
NCI.
09-25-0154, Biomedical Research Records of Subjects: (1) Cancer
Studies of the Division of Cancer Prevention and Control, HHS/NIH/
NCI; and (2) Women's Health Initiative (WHI) Studies, HHS/NIH/
OD. [[Page 4240]]
09-25-0165, National Institutes of Health Loan Repayment Program,
HHS/NIH/OD.
09-25-0166, Administration: Radiation and Occupational Safety and
Health Management Information System, HHS/NIH/ORS.
09-25-0168, Invention, Patent and Licensing Documents Submitted to
the Public Health Service by its Employees, Grantees, Fellowship
Recipients and Contractors, HHS/PHS/NIH/OTT.
09-25-0170, Diabetes Control and Complications Trial (DCCT) Data
System, HHS/NIH/NIDDK.
09-25-0207, Subject-Participants in Pharmacokinetic Studies on Drugs
of Abuse and on Treatment Medications, HHS/NIH/NIDA.
09-25-0209, Subject-Participants in Drug Abuse Research Studies on
Drug Dependence and in Research Supporting New Drug Applications,
HHS/NIH/NIDA.
09-25-0212, Clinical Research: Neuroscience Research Center Patient
Medical Records, HHS/NIH/NIMH.
N. Organization name change. There are no changes in this category.
O. Deleted systems of records. The following systems of records
which appeared in the December 29, annual publication are now being
deleted because:
09-25-0100, Clinical Research: Neuropharmacology Studies, HHS/NIH/
NINDS. The records have been destroyed.
09-25-0151, Administration: Public Health Service ALERT Records
Concerning Individuals Under Investigation for Possible Misconduct
In Science or Subject to Sanctions for Such Misconduct, HHS/PHS/OSR.
The system has been officially transferred to the Office of the
Assistant Secretary for Health (OASH), Office of Research Integrity
(ORI).
The following is a list of active systems of records maintained by
NIH. Table of Contents.
09-25-0001, Clinical Research: Patient Records, HHS/NIH/NHLBI,
published Federal Register, Vol. 56, Number 247, December 24, 1991.
09-25-0005, Administration: Library Operations and User I.D. File,
HHS/NIH/OD, published Federal Register, Vol. 58, No. 248, December
29, 1993.
09-25-0007, Administration: NIH Safety Glasses Issuance Program,
HHS/NIH/ORS, published Federal Register, Vol. 58, No. 248, December
29, 1993.
09-25-0010, Research Resources: Registry of Individuals Potentially
Exposed to Microbial Agents, HHS/NIH/NCI, published Federal
Register, Vol. 56, No. 247, December 24, 1991.
09-25-0011, Clinical Research: Blood Donor Records, HHS/NIH/CC,
published Federal Register, Vol. 56, Number 247, December 24, 1991.
09-25-0012, Clinical Research: Candidate Normal Volunteer Records,
HHS/NIH/CC, published, Federal Register, Vol. 56, No. 247, December
24, 1991.
09-25-0014, Clinical Research: Student Records, HHS/NIH/CC,
published Federal Register, Vol. 56, No. 8, January 11, 1991.
09-25-0015, Clinical Research: Collaborative Clinical Epilepsy
Research, HHS/NIH/NINDS, published Federal Register, Vol. 56, No. 8,
January 11, 1991.
09-25-0016, Clinical Research: Collaborative Perinatal Project HHS/
NIH/NINDS, published Federal Register, Vol. 56, No. 247, December
24, 1991.
09-25-0026, Clinical Research: Nervous System Studies, HHS/NIH/
NINDS, published Federal Register, Vol. 56, No. 247, December 24,
1991.
09-25-0028, Clinical Research: Patient Medical Histories, HHS/NIH/
NINDS and HHS/NIH/NIDCD, published Federal Register, Vol. 58, No. 8,
January 13, 1993.
09-25-0031, Clinical Research: Serological and Virus Data in Studies
Related to the Central Nervous System, HHS/NIH/NINDS, published
Federal Register, Vol. 58, No. 248, December 29, 1993.
09-25-0033, International Activities: Fellowships Awarded by Foreign
Organizations, HHS/NIH/FIC, published Federal Register, Vol. 56, No.
247, December 24, 1991.
09-25-0034, International Activities: Scholars-in-Residence Program,
HHS/NIH/FIC, published Federal Register, Vol. 56, No. 8, January 11,
1991.
09-25-0035 International Activities: Health Scientist Exchange
Programs, HHS/NIH/FIC, published Federal Register, Vol. 56, No. 247,
December 24, 1991.
09-25-0036, Extramural Awards and Chartered Advisory Committees:
IMPAC (Grant/Contract/Cooperative Agreement/Chartered Advisory
Committee, HHS/NIH/DRG and HHS/NIH/CMO, published Federal Register,
Vol. 58, No. 248, December 29, 1993.
09-25-0037, Clinical Research: The Baltimore Longitudinal Study of
Aging, HHS/NIH/NIA, published Federal Register, Vol. 58, No. 248,
December 29, 1993.
09-25-0038, Clinical Research: Patient Data, HHS/NIH/NIDDK,
published Federal Register, Vol. 58, No. 248, December 29, 1993.
09-25-0039, Clinical Research: Diabetes Mellitus Research Study of
Southwestern American Indians, HHS/NIH/NIDDK, published Federal
Register, Vol. 56, No. 247, December 24, 1991.
09-25-0040, Clinical Research: Southwestern American Indian Patient
Data, HHS/NIH/NIDDK, published Federal Register, Vol. 56, No. 247,
December 24, 1991.
09-25-0041, Research Resources: Scientists Requesting Hormone
Distribution, HHS/NIH/NIDDK, published Federal Register, Vol. 56,
No. 8, January 11, 1991.
09-25-0042, Clinical Research: National Institute of Dental Research
Patient Records, HHS/NIH/NIDR, published Federal Register, Vol. 58,
No. 248, December 29, 1993.
09-25-0044, Clinical Research: Sensory Testing Research Program,
HHS/NIH/NIDR, published Federal Register, Vol. 56, No. 247, December
24, 1991.
09-25-0046, Clinical Research: Catalog of Clinical Specimens from
Patients, Volunteers and Laboratory Personnel, HHS/NIH/NIAID,
published Federal Register, Vol. 58, No. 248, December 29, 1993.
09-25-0053, Clinical Research: Vision Studies, HHS/NIH/NEI,
published Federal Register, Vol. 56, No. 247, December 24, 1991.
09-25-0054, Administration: Property Accounting, HHS/NIH/ORS,
published Federal Register, Vol. 56, No. 247, December 24, 1991.
09-25-0057, Clinical Research: Burkitts's Lymphoma Registry, HHS/
NIH/NCI, published Federal Register, Vol. 56, No. 8, January 11,
1991.
09-25-0060, Clinical Research: Division of Cancer Treatment Clinical
Investigations, HHS/NIH/NCI, published Federal Register, Vol. 58,
No. 248, December 29, 1993.
09-25-0067, Clinical Research: National Cancer Incidence Surveys,
HHS/NIH/NCI, published Federal Register, Vol. 56, No. 8, January 11,
1991.
09-25-0069, NIH Clinical Center Admissions of the National Cancer
Institute, HHS/NIH/NCI, published Federal Register, Vol. 58, No.
248, December 29, 1993.
09-25-0074, Clinical Research: Division of Cancer Biology and
Diagnosis Patient Trials, HHS/NIH/NCI, published Federal Register,
Vol. 56, No. 8, January 11, 1991.
09-25-0077, Biological Carcinogenesis Branch Human Specimen Program,
HHS/NIH/NCI, published Federal Register, Vol. 56, No. 247, December
24, 1991.
09-25-0078, Administration: Consultant File, HHS/NIH/NHLBI,
published Federal Register, Vol. 56, No. 8, January 11, 1991.
09-25-0087, Administration: Senior Staff, HHS/NIH/NIAID, published
Federal Register, Vol. 58, No. 248, December 29, 1993.
09-25-0091, Administration: General Files on Employees, Donors and
Correspondents, HHS/NIH/NEI, published Federal Register, Vol. 56,
No. 247, December 24, 1991.
09-25-0093, Administration: Administration Authors, Reviewers and
Members of the Journal of the National Cancer Institute, HHS/NIH/
NCI, published Federal Register, Vol. 56, No. 8, January 11, 1991.
09-25-0099, Clinical Research: Patient Medical Records, HHS/NIH/CC,
published Federal Register, Vol. 56, No. 247, December 24, 1991.
09-25-0102, Administration: Grants Associates Program Working Files,
HHS/NIH/OER, published Federal Register, Vol. 56, No. 8, January 11,
1991.
09-25-0105, Administration: Health Records of Employees, Visiting
Scientists, Fellows, Contractors and Relatives of Inpatients, HHS/
NIH/ORS, published Federal Register, Vol. 58, No. 248, December 29,
1993.
09-25-0106, Administration: Office of the NIH Director and
Institute/Center/Division Correspondence Records, HHS/NIH/OD,
published Federal Register, Vol. 58, No. 248, December 29, 1993.
09-25-0108, Personnel: Guest Researchers, Special Volunteers, and
Scientists Emeriti, HHS/NIH/OHRM, published Federal Register, Vol.
58, No. 248, December 29, 1993. [[Page 4241]]
09-25-0112, Grants and Cooperative Agreements: Research, Research
Training, Fellowship and Construction Applications and Related
Awards, HHS/NIH/OD, published Federal Register, Vol. 58, No. 248,
December 29, 1993.
09-25-0115, Administration: Curricula Vitae of Consultants and
Clinical Investigators, HHS/NIH/NIAID, published Federal Register,
Vol. 58, No. 248, December 29, 1993.
09-25-0118, Contracts: Professional Services Contractors, HHS/NIH/
NCI, published Federal Register, Vol. 58, No. 248, December 29,
1993.
09-25-0121, International Activities: Senior International
Fellowships Program, HHS/NIH/FIC, published Federal Register, Vol.
56, No. 247, December 24, 1991.
09-25-0124, Administration: Pharmacology Research Associates, HHS/
NIH/NIGMS, published Federal Register, Vol. 58, No. 8, January 13,
1993.
09-25-0126, Clinical Research: National Heart, Lung, and Blood
Institute Epidemiological and Biometric Studies, HHS/NIH/NHLBI,
published Federal Register, Vol. 58, No. 8, January 13, 1993.
09-25-0128, Clinical Research: Neural Prosthesis and Biomedical
Engineering Studies, HHS/NIH/NINDS, published Federal Register, Vol.
58, No. 248, December 29, 1993.
09-25-0129, Clinical Research: Clinical Research Studies Dealing
with Hearing, Speech, Language and Chemosensory Disorders, HHS/NIH/
NIDCD, published Federal Register, Vol. 56, No. 247, December 24,
1991.
09-25-0130, Clinical Research: Studies in the Division of Cancer
Cause and Prevention, HHS/NIH/NCI, published Federal Register, Vol.
56, No. 8, January 11, 1991.
09-25-0134, Clinical Research: Epidemiology Studies, National
Institute of Environmental Health Sciences, HHS/NIH/NIEHS, published
Federal Register, Vol. 58, No. 248, December 29, 1993.
09-25-0140, International Activities: International Scientific
Researchers in Intramural Laboratories at the National Institutes of
Health, HHS/NIH/FIC, published Federal Register, Vol. 58, No. 248,
December 29, 1993.
09-25-0142, Clinical Research: Records of Subjects in Intramural
Research, Epidemiology, Demography and Biometry Studies on Aging,
HHS/NIH/NIA, published Federal Register, Vol. 58, No. 8, January 13,
1993.
09-25-0143, Biomedical Research: Records of Subjects in Clinical,
Epidemiologic and Biometric Studies of the National Institute of
Allergy and Infectious Diseases, HHS/NIH/NIAID, published Federal
Register, Vol. 58, 'No. 248, December 29, 1993.
09-25-0145, Clinical Trials and Epidemiological Studies Dealing with
Visual Disease and Disorders in the National Eye Institute, HHS/NIH/
NEI, published Federal Register, Vol. 58, No. 248, December 29,
1993.
09-25-0148, Contracted and Contract-Related Research: Records of
Subjects in Clinical, Epidemiological and Biomedical Studies of the
National Institute of Neurological Disorders and Stroke and the
National Institute on Deafness and Other Communication Disorders,
HHS/NIH/NINDS and HHS/NIH/NIDCD, published Federal Register, Vol.
56, No. 247, December 24, 1991.
09-25-0152, Biomedical Research: Records of Subjects in National
Institute of Dental Research Contracted Epidemiological and
Biometric Studies, HHS/NIH/NIDR, published Federal Register, Vol.
58, No. 8, January 13, 1993.
09-25-0153, Biomedical Research: Records of Subjects in Biomedical
and Behavioral Studies of Child Health and Human Development, HHS/
NIH/NICHD, published Federal Register, Vol. 58, No. 8, January 13,
1993.
09-25-0154, Biomedical Research Records of Subjects: (1) Cancer
Studies of the Division of Cancer Prevention and Control, HHS/NIH/
NCI; and (2) Women's Health Initiative (WHI) Studies, HHS/NIH/OD,
published Federal Register, Vol. 58, Number 8, January 13, 1993.
09-25-0156, Records of Participants in Programs and Respondents in
Surveys Used to Evaluate Programs of the Public Health Service, HHS/
PHS/NIH/OD, published Federal Register, Vol. 58, No. 248, December
29, 1993.
09-25-0158, Administration: Records of Applicants and Awardees of
the NIH Intramural Research Training Awards Program, HHS/NIH/OD,
published Federal Register, Vol. 58, No. 248, December 29, 1993.
09-25-0160, United States Renal Data System (USRDS), HHS/NIH/NIDDK
published Federal Register, Vol. 56, No. 8, January 11, 1991.
09-25-0161, Administration: NIH Consultant File, HHS/NIH/DRG,
published Federal Register, Vol. 58, No. 248, December 29, 1993.
09-25-0165, National Institutes of Health Loan Repayment Program,
HHS/NIH/OD, published Federal Register, Vol. 58, No. 248, December
29, 1993.
09-25-0166, Administration: Radiation and Occupational Safety and
Health Management Information System, HHS/NIH/ORS, published Federal
Register, Vol. 56, No. 247, December 24, 1991.
09-25-0167, National Institutes of Health (NIH) Transhare Program,
HHS/NIH/OD, published Federal Register, Vol. 57, No. 171, September
2, 1992.
09-25-0168, Invention, Patent and Licensing Documents Submitted to
the Public Health Service by its Employees, Grantees, Fellowship
Recipients and Contractors, HHS/PHS/NIH/OTT, published Federal
Register, Vol. 58, No. 164, August 26, 1993.
09-25-0169, Medical Staff Credentials Files, HHS/NIH/CC, published
Federal Register, Vol. 59, No. 207, October 27, 1994.
09-25-0170, Diabetes Control and Complications Trial (DCCT) Data
System, HHS/NIH/NIDDK, published Federal Register, Vol. 58, No. 248,
December 29, 1993.
09-25-0201, Clinical Research: National Institute of Mental Health
Patient Records, HHS/NIH/NIMH, published Federal Register, Vol. 58,
No. 8, January, 13, 1993.
09-25-0202, patient Records on PHS Beneficiaries (1935-1974) and
Civilly Committed Drug Abusers (1967-1976) Treated at the PHS
Hospitals in Fort Worth, Texas, or Lexington, Kentucky, HHS/NIH/
NIDA, published Federal Register, Vol. 58, No. 8, January 13, 1993.
09-25-0203, National Institute on Drug Abuse, Addiction Research
Center, Federal Prisoner and Non-Prisoner Research Files, HHS/NIH/
NIDA, published Federal Register, Vol. 58, No. 8, January 13, 1993.
09-25-0205, Alcohol, Drug Abuse, and Mental Health Epidemiologic and
Biometric Research Data, HHS/NIH/NIAAA, HHS/NIH/NIDA and HHS/NIH/
NIMH, published Federal Register, Vol. 58, No. 248, December 29,
1993.
09-25-0207, Subject-Participants in Pharmacokinetic Studies on Drugs
of Abuse and on Treatment Medications, HHS/NIH/NIDA, published
Federal Register, Vol. 58, No. 248, December 29, 1993.
09-25-0208, Drug Abuse Treatment Outcome Study (DATOS), HHS/NIH/
NIDA, published Federal Register, Vol. 58, No. 248, December 29,
1993.
09-25-0209, Subject-Participants in Drug Abuse Research Studies on
Drug Dependence and in Research Supporting New Drug Applications,
HHS/NIH/NIDA, published Federal Register, Vol. 58, No. 8, January
13, 1993.
09-25-0210, Shipment Records of Drugs of Abuse to Authorized
Researchers, HHS/NIH/NIDA, published Federal Register, Vol. 58, No.
248, December 29, 1993.
09-25-0211, Intramural Research Program Records of In- and Out-
Patients with Various Types of Alcohol Abuse and Dependence,
Relatives of Patients With Alcoholism, and Healthy Volunteers, HHS/
NIH/NIAAA, published Federal Register, Vol. 58, No. 248, December
29, 1993.
09-25-0212, Clinical Research: Neuroscience Research Center Patient
Medical Records, HHS/NIH/NIMH, published Federal Register, Vol. 58,
No. 8, January 13, 1993.
Dated: January 10, 1995.
Cdr. Cheryl A. Seaman,
Acting Director, Division of Management Support, OMA, OA, OD, National
Institutes of Health.
09-25-0001
Clinical Research: Patient Records, HHS/NIH/NHLBI.
None.
National Institutes of Health, Building 10, 9000 Rockville Pike,
Bethesda, MD 20892
Patients of the National Heart, Lung, and Blood Institute (NHLBI)
under study at the National Institutes of Health (NIH). [[Page 4242]]
Medical histories, diagnostic studies, laboratory data, treatment.
42 USC 241(e), 287, 287a.
(1) For use by physicians in evaluation and treatment of patients
under study at NIH. (2) To furnish patient data to patients, their
families, and with patients' consent, to their private physicians.
1. Clinical research data are made available to approved or
collaborating researchers, including HHS contractors and grantees.
2. Certain diseases and conditions, including infectious diseases,
may be reported to appropriate representatives of State or Federal
Government as required by State or Federal law.
3. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity: (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example in defending against a claim based upon an
individual's mental or physical condition and alleged to have arisen
because of activities of the Public Health Service in connection with
such individual, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice or other
appropriate Federal agency to enable that agency to present an
effective defense, provided that such disclosure is compatible with the
purpose for which the records were collected.
4. (a). PHS may inform the sexual and/or needle-sharing partner(s)
of a subject individual who is infected with the human immunodeficiency
virus (HIV) of their exposure to HIV, under the following
circumstances: (1) The information has been obtained in the course of
clinical activities at PHS facilities carried out by PHS personnel or
contractors; (2) The PHS employee or contractor has made reasonable
efforts to counsel and encourage the subject individual to provide the
information to the individual's sexual or needle-sharing partner(s);
(3) The PHS employee or contractor determines that the subject
individual is unlikely to provide the information to the sexual or
needle-sharing partner(s) or that the provision of such information
cannot reasonably be verified; and (4) The notification of the
partner(s) is made, whenever possible, by the subject individual's
physician or by a professional counselor and shall follow standard
counseling practices.
(b). PHS may disclose information to State or local public health
departments, to assist in the notification of the subject individual's
sexual and/or needle-sharing partner(s), or in the verification that
the subject individual has notified such sexual or needle-sharing
partner(s).
File folders, card index, laboratory books, computer memory.
Indexed by name or patient number.
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location. Each site implements personnel,
physical, and procedural safeguards such as the following:
1. Authorized users: Employees who maintain records in this system
are instructed to grant regular access only to authorized physicians
and their assistants.
2. Physical safeguards: Records are kept in secure locked metal or
wood file cabinets and, in some instances, in locked offices.
3. Procedural safeguards: Access to files is strictly controlled by
files staff. Access to computerized records is controlled by keyword
codes available only to authorized users.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and Part 6, ``ADP Systems Security,'' of the HHS Information Resources
Management Manual and the National Institute of Standards and
Technology Federal Information Processing Standards (FIPS Pub. 41 and
FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific conditions on disposal.
Administrative Officer, Division of Intramural Research, National
Heart, Lung, and Blood Institute, 10/7N220, 10 Center Drive, MSC 1670,
Bethesda, MD 20892-1670
To determine if a record exists, contact: National Institutes of
Health, Privacy Act Coordinator, NHLBI, Building 31, Room 5A08, 9000
Rockville Pike, Bethesda, MD 20892.
An individual who requests notification of or access to a medical
record shall, at the time the request is made, designate in writing, a
responsible representative, who may be a physician, who will be willing
to review the record and inform the subject individual of its contents
at the representative's discretion.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Contact the official under notification procedures above, and
specify the information to be contested, the corrective action sought,
and the reasons for the correction, with supporting justification. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
Referring physicians, hospitals and medical centers, patients and
families, results of procedures and tests of NIH patients.
None.
09-25-0005
Administration: Library Operations and User I.D. File, HHS/NIH/OD.
None.
This system of records is an umbrella system comprising separate
sets of [[Page 4243]] records located in National Institutes of Health
(NIH) facilities in Bethesda, Maryland, or facilities of contractors of
the NIH. Write to the appropriate system manager listed below for list
of current contractor locations.
National Institutes of Health, Building 10, Room 1L07, 9000 Rockville
Pike, Bethesda, MD 20892
and
National Institutes of Health, Building 12A, Room 3018, 9000 Rockville
Pike, Bethesda, MD 20892
and
National Institutes of Health, Building 38, Room 1S33, 8600 Rockville
Pike, Bethesda, MD 20894
and
National Institutes of Health, Building 38, Room 1N21, 8600 Rockville
Pike, Bethesda, MD 20894
and
National Institutes of Health, Building 38, Room B1E21, 8600 Rockville
Pike, Bethesda, MD 20894
and
National Institutes of Health, Building 38A, Room 4N419, 8600 Rockville
Pike, Bethesda, MD 20894
and
National Technical Information Service, Accounting Department, 8001
Forbes Place, Room 208F, Springfield, Virginia 22151
Users of Library Services.
Name, organization, address, phone number, user code and
identification number; and when applicable, credit card number and
billing information.
Section 301 of the Public Health Service Act, describing the
general powers and duties of the Public Health Service relating to
research and investigation (42 U.S.C. 241).
(1) To monitor library material, services, and circulation control;
(2) to provide user documentation; (3) to provide copying services
(duplication of library materials); and (4) to manage invoice and
billing transactions for library services.
1. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
2. The Department of Health and Human Services (HHS) may disclose
information from this system of records to the Department of Justice,
or to a court or other tribunal, when (a) HHS, or any component
thereof; or (b) any HHS employee in his or her official capacity; or
(c) any HHS employee in his or her individual capacity where the
Department of Justice (or HHS, where it is authorized to do so) has
agreed to represent the employee; or (d) the United States or any
agency thereof where HHS determines that the litigation is likely to
affect HHS or any of its components, is a party to litigation or has an
interest in such litigation, and HHS determines that the use of such
records by the Department of Justice, court or other tribunal is
relevant and necessary to the litigation and would help in the
effective representation of the government party, provided, however
that in each case, HHS determines that such disclosure is compatible
with the purpose for which the records were collected.
3. Disclosure may be made to contractors and staff to monitor
library material, services, circulation control; to provide user
documentation; and to process or refine the records. Recipients are
required to maintain Privacy Act safeguards with respect to those
records.
4. Disclosure may be made for billing purposes to: (a) Contractors
providing copying services: and (b) NTIS for Medlars Services.
Records are stored on computer tape and disc, microfiche, paper and
file cards.
Records are retrieved by name, user code and/or identification
number.
1. Authorized users: Employees who maintain records in this system
are instructed to grant regular access only to Library staff members
who need to verify that Library identification cards have been issued
to those Library users requesting services such as MEDLINE and other
computer online bibliographic searches, translations and interlibrary
loans. Other one-time and special access by other employees is granted
on a need-to-know basis as specifically authorized by the system
manager. The contractor maintains a list of personnel having authority
to access records to perform their duties.
2. Physical safeguards: The offices housing the cabinets and file
drawers for storage of records are locked during all library off-duty
hours. During all duty hours offices are attended by employees who
maintain the files. The contractor has secured records storage areas
which are not left unattended during the working hours and file
cabinets which are locked after hours.
3. Procedural safeguards: Access to the file is strictly controlled
by employees who maintain the files. Records may be removed from files
only at the request of the system manager or other authorized
employees. Access to computerized records is controlled by the use of
security codes known only to authorized users. Contractor personnel
receive instruction concerning the significance of safeguards under the
Privacy Act.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and Part 6, ``ADP Systems Security,'' of the HHS Information Resources
Management Manual and the National Institute of Standards and
Technology Federal Information Processing Standards (FIPS Pub. 41 and
FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 8000-D-2, which allows records to be kept until
superseded or for a maximum period of 6 years. Refer to the NIH Manual
Chapter for specific conditions on disposal.
The Policy Coordinating Official for this system is the Management
Analyst, Office of Administration, National Library of Medicine;
Building 38, Room 2N21; 8600 Rockville Pike; Bethesda, MD 20894.
Chief, Reference and Bibliographic Services Section, Library Branch,
National Center for Research Resources, National Institutes of Health,
Building 10, Room 1L21, 9000 Rockville Pike, Bethesda, MD 20892
and
Chief, Division of Computer Research and Technology Library, National
Institutes of Health, Building 12A, Room 3018, 9000 Rockville Pike,
Bethesda, MD 20892
[[Page 4244]] and
Supervisory Librarian, Preservation and Collection Management Section,
Public Services Division, Library Operations, National Library of
Medicine, National Institutes of Health, Building 38, Room B1E21, 8600
Rockville Pike, Bethesda, MD 20894
and
Chief, Public Services Division, Library Operations, National Library
of Medicine, National Institutes of Health, Building 38, Room 1S33,
8600 Rockville Pike, Bethesda, MD 20894
and
Head, Prints and Photographs Collection, History of Medicine Division,
NLM, NIH, Building 38, Room 1N21, 8600 Rockville Pike, Bethesda, MD
20894
and
Chief, Medlars Management Section, Bibliographic Services Division,
Library Operations, National Institutes of Health, National Library of
Medicine, Building 38A, Room 4N419, 8600 Rockville Pike, Bethesda, MD
20894
Write to the System Manager to determine if a record exists. The
requester must also verify his or her identity by providing either a
notarization of the request or a written certification that the
requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
an accounting of disclosures that have been made of their records, if
any.
Write to the official at the address specified under notification
procedures above, and reasonably identify the record and specify the
information to be contested, the corrective action sought, and the
reasons for the correction, along with supporting information to show
how the record is inaccurate, incomplete, untimely, or irrelevant. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
Individual, NIH Library ID card data.
None.
09-25-0011
Clinical Research: Blood Donor Records, HHS/NIH/CC.
None
National Institutes of Health, Transfusion Medicine Department, 10
Center Drive MSC 1184, Bethesda, MD 20892-1184
Donors of blood and blood components to be used in the NIH Clinical
Center for patient infusions.
Past donations, blood types, phenotypes. Laboratory results of
hepatitis testing, serologic reactions on all blood samples, donations
of blood or blood components.
``Preparation of Biological Products'' of the Public Health Service
Act (42 U.S.C. 263).
(1) To provide a means for contacting blood donors for patient care
and research. (2) To provide a medical history of all donors for the
transfusion records of each blood unit.
1. Disclosure may be made to HHS contractors and their staff in
order to accomplish the purposes for which the records are collected.
The recipients are required to comply with the requirements of the
Privacy Act with respect to such records.
2. Certain diseases and conditions, including infectious diseases,
may be reported to State or Federal government as required by State or
Federal law.
3. Disclosure may be made to a congressional office from the record
of individual in response to an inquiry from the congressional office
made at the request of that individual.
4. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or here official capacity; (b) the United States
where the Department determines that claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example in defending against a claim based upon an
individual's mental or physical condition and alleged to have arisen
because of activities of the Public Health Service in connection with
such individual, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice or other
appropriate Federal agency to enable that agency to present an
effective defense, provided that such disclosure is compatible with the
purpose for which the records were collected.
5. (a). PHS may inform the sexual and/or needle-sharing partner(s)
of a subject individual who is infected with the human immunodeficiency
virus (HIV) of their exposure to HIV, under the following
circumstances: (1) The information has been obtained in the course of
clinical activities at PHS facilities carried out by PHS personnel or
contractors; (2) The PHS employee or contractor has made reasonable
efforts to counsel and encourage the subject individual to provide the
information to the individual's sexual or needle-sharing partner(s);
(3) The PHS employee or contractor determines that the subject
individual is unlikely to provide the information to the sexual or
needle-sharing partner(s) or that the provision of such information
cannot reasonably be verified; and (4) The notification of the
partner(s) is made, whenever possible, by the subject individual's
physician or by a professional counselor and shall follow standard
counseling practices.
(b). PHS may disclose information to State or local public health
departments, to assist in the notification of the subject individual's
sexual and/or needle-sharing partner(s), or in the verification that
the subject individual has notified such sexual or needle-sharing
partner(s).
Records are stored in a computer file, on donor cards, and on
microfilm.
Records are retrieved by a unique control number assigned to each
individual donor.
Access is granted only to authorized employees in the Department of
Transfusion Medicine including [[Page 4245]] physicians, nurses,
technologists, computer operators, and the department's administrative
officer.
1. Authorized users: Access is granted only to authorized employees
of the Department of Transfusion Medicine including physicians, nurses
technologists, computer operators and the secretary to the Chief.
2. Physical safeguards: Record facilities are locked when system
personnel are not present.
3. Procedural safeguards: Access to manual files is limited to
authorized users. Access to computerized records is controlled by the
use of security codes known only to the authorized users.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and Part 6, ``ADP Systems Security,'' of the HHS Information Resources
Management Manual and the National Institute of Standards and
Technology Federal Information Processing Standards (FIPS Pub. 41 and
FIPS Pub. 31).
Records are retained and disposed of under the authority of the HIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-E-50. Refer to the NIH Manual Chapter for
specific conditions on disposal.
Chief, Tranfusion Medicine Department, National Institutes of Health,
10 Center Drive MSC 1184, Bethesda, MD 20892-1184.
Write to the System Manager to determine if a record exists. The
requester must also verify his or her identify by providing either a
notarization of the request or a written certification that the
requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
An individual who requests notification of or access to a medical
record shall, at the time the request is made, designate in writing, a
responsible representative, who may be a physician, who will be willing
to review the record and inform the subject individual of its contents
at the representative's discretion.
To obtain access to a record, contact the system manager at the
address specified above. Requestors should provide the same information
as is required under the notification procedures above. Individuals may
also request listings of accountable disclosures that have been made of
their records, if any.
Write to the official specified under notification procedures
above, and reasonably identify the record and specify the information
being contested, the corrective action sought, and your reasons for
requesting the correction, along with supporting information to show
how the record is inaccurate, incomplete, untimely, or irrelevant. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
Data are collected from the individual.
None.
09-25-0012
Clinical Research: Candidate Normal Volunteer Records, HHS/NIH/CC.
None.
National Institutes of Health, Social Work Department, 10 Center Drive
MSC 1160, Bethesda, MD 20892-1160.
Normally healthy individuals who volunteer to participate in NIH
studies.
Program application, health questionnaire and record of
participation.
42 U.S.C. 241, 263.
(1) To determine suitability for participation in the normal
volunteer program, (2) to document remuneration of normal volunteers,
(3) to provide a record of participation to be used (a) in writing
letters of recommendation/reference for the volunteer, and (b)
preparing reports on the normal volunteer program.
1. Clinical research data are made available to approved or
collaborating researchers, including HHS contractors and grantees.
2. Certain diseases and conditions, including infectious diseases,
may be reported to appropriate representatives of State or Federal
Government as required by State or Federal law.
3. Information may be used to respond to congressional inquiries
for constituents concerning admission to the NIH Clinical Center.
4. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
Program applications and health questionnaires are stored in file
folders. Records of participation are stored on index cards.
Records are retrieved by name.
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location and for the particular records maintained
in each project. Each site implements personnel, physical, procedural
safeguards such as the following:
1. Authorized users: Access is granted only to the Normal Volunteer
Program staff and to NIH physicians who have requested the recruitment
of volunteers for their clinical research projects.
2. Physical safeguards: Access to the files is strictly controlled
by the files staff. Records may be removed from the file only at the
request of the system manager or other authorized employees. Record
facilities are locked when system personnel are not present.
3. Procedural safeguards: Access to the files is strictly
controlled by the files staff. Records may be removed from the file
only at the request of the system manager or other authorized
employees.
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-E-61, which allows records to be kept until
[[Page 4246]] superseded for a maximum period of 3 years. Refer to the
NIH Manual Chapter for specific conditions on disposal.
Chief, Social Work Department, National Institutes of Health, Social
Work Department, 10 Center Drive MSC 1160, Bethesda, MD 20892-1160.
Write to the System Manager to determine if a record exists. The
requester must also verify his or her identity by providing either a
notarization of the request or a written certification that the
requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
An individual who requests notification of or access to a medical
record shall, at the time the request is made, designate in writing, a
responsible representative, who may be a physician, who will be willing
to review the record and inform the subject individual of its contents
at the representative's discretion.
A parent or guardian who requests notification of, or access to, a
child's or incompetent person's medical record shall designate a family
physician or other health professional (other than a family member) to
whom the record, if any, will be sent. The parent or guardian must
verify relationship to the child or incompetent person as well as his
or her own identity.
To obtain access to a record, contact: Chief, Social Work
Department, National Institutes of Health, Social Work Department, 10
Center Drive MSC 1160, Bethesda, MD 20892-1160 and provide the
information described under Notification Procedures above. Requesters
should also reasonably specify the record contents being sought.
Individuals may also request listings of accountable disclosures that
have been made of their records, if any.
Write to the official at the address specified under notification
procedures above, and reasonably identify the record and specify the
information to be contested, the corrective action sought, and the
reasons for the correction, with supporting justification. The right to
contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
Volunteer, sponsoring contractor.
None.
09-25-0014
Clinical Research: Student Records, HHS/NIH/CC.
None.
National Institutes of Health, Office of Education, 10 Center Drive
MSC 1158, Bethesda, MD 20892-1158.
Write to the system manager at the address below for the address of
any Federal Records Center where records from this system may be
stored.
Potential and accepted Medical Staff and Research Fellows, medical
students, and other students in NIH training programs.
Application form, transcripts, references, evaluations.
42 U.S.C. 241.
(1) To identify candidates for Medical Staff and Research Fellow,
clinical elective, and other training positions. (2) To maintain a
permanent record of those individuals who have received clinical
research training at the NIH for historical and reference uses.
1. Information may be used to respond to congressional inquiries
for constituents concerning admission to the program.
2. Information may be used to respond to prospective future
employers of these individuals who wish to confirm their presence at
NIH.
Records are stored in file folders.
Records are retrieved by name and year.
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location and for the particular records maintained
in each project. Each site implements personnel, physical, procedural
safeguards such as the following:
1. Authorized users: Employees who maintain records in this system
are instructed to grant regular access only to health care personnel of
the NIH who are involved in the evaluation and selection of training
candidates.
2. Physical safeguards: Records are maintained in locked cabinets
with access limited to authorized personnel, including the systems
manager and staff of the Normal Volunteer Program.
3. Procedural safeguards: Access to the files is strictly
controlled by the files staff. Records may be removed from the file
only at the request of the system manager or other authorized
employees.
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), items 2300-320-1-13, which allows records to be kept
up to a maximum period of 10 years. Refer to the NIH Manual Chapter for
specific disposition instructions.
Director, Office of Education, National Institutes of Health, 10
Center Drive MSC 1158, Bethesda, MD 20892-1158.
Write to the System Manager to determine if a record exists. The
requester must also verify his or her identity by providing either a
notarization of the request or a written certification that the
requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
To obtain access to a record, contact the system manager at the
above address and provide the information described under Notification
Procedures above. Requesters should also reasonably specify the record
contents being sought. Individuals may also request listings of
accountable disclosures that have been made of their records, if any.
Write to the system manager at the address specified above, and
reasonably identify the record and specify the information to be
contested, the [[Page 4247]] corrective action sought, and the reasons
for the correction, with supporting justification. The right to contest
records is limited to information which is incomplete, irrelevant,
incorrect, or untimely (obsolete).
Applicants, universities and teachers.
None.
09-25-0026
Clinical Research: Nervous System Studies, HHS/NIH/NINDS.
None.
Building 36, Room 5B20, NIH, 9000 Rockville Pike, Bethesda, MD 20892.
Write to the system manager at the address below for the address of
any Federal Records Center where records from this system may be
stored.
Research patients in NIH-related studies having nervous system
disorders.
Medical and demographic data.
42 U.S.C. 241, 289a, 289c.
Clinical research by HHS scientists on patients with special
diseases of the nervous system, with particular emphasis on those
diseases known or thought to be caused by slow or latent viruses.
1. Clinical research data are made available to approved or
collaborating researchers, including HHS contractors and grantees.
2. Certain diseases and conditions, including infectious diseases,
may be are reported to appropriate representatives of State or Federal
Government as required by State or Federal law.
3. Information may be used to respond to congressional inquiries
for constituents concerning admission to the NIH Clinical Center. In
the event of litigation where the defendant is: (a) The Department, any
component of the Department, or any employee of the Department in his
or her official capacity; (b) the Untied States where the Department
determines that the claim, if successful, is likely to directly affect
the operations of the Department or any of its components; or (c) any
Department employee in his or her individual capacity where the Justice
Department has agreed to represent such employee, for example in
defending against a claim based upon an individual's mental or physical
condition and alleged to have arisen because of activities of the
Public Health Service in connection with such individual, the
Department may disclose such records as it deems desirable or necessary
to the Department of Justice or other appropriate Federal agency to
enable that agency to present an effective defense, provided that such
disclosure is compatible with the purpose for which the records were
collected.
Records are stored in file folders, in computer-accessible forms,
bound notebooks, graphs, and imaging films.
Records are retrieved by name, disease and attending physician
name.
1. Authorized users: Employees who maintain records in this system
are instructed to grant access only to scientists on the staff of the
Central Nervous System Studies Laboratory and their assistants.
2. Physical safeguards: Records are kept in a locked location.
3. Procedural safeguards: Personnel having access to system are
informed of Privacy Act requirements.
This system of records will be protected according to the standards
of Chapter 45-13 of the HHS General Administration Manual,
``Safeguarding Records Contained in Systems of Records,'' supplementary
Chapter PHS hf: 45-13, and Part 6, ``ADP Systems Security,'' of the HHS
Information Resources Management Manual and the National Institute of
Standards and Technology Federal Information Processing Standards (FIPS
Pub. 41 and FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
Assistant Director, CNP, DIR, NINDS, NIH, Building 10, Room 5N226, 9000
Rockville Pike, Bethesda, MD 20892.
To determine if a record exists, contact: Chief, Administrative
Services Branch, NINDS, Building 31, Room 8A49, NIH, 9000 Rockville
Pike, Bethesda, MD 20892.
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
An individual who requests notification of or access to a medical/
dental record shall, at the time the request is made, designate in
writing, a responsible representative who will be willing to review the
record and inform the subject individual of its contents at the
representative's discretion.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Contact the official at the address specified under notification
procedures above, and reasonably identify the record and specify the
information to be contested. The right to contest records is limited to
information which is incomplete, irrelevant, incorrect, or untimely
(obsolete).
Attending physicians.
None.
09-25-0028
Clinical Research: Patient Medical Histories, HHS/NIH/NINDS and
HHS/NIH/NIDCD.
None. [[Page 4248]]
Building 10, Building 31, and Building 36, NIH, 9000 Rockville Pike,
Bethesda, MD 20892.
Write to the system manager at the address below for the address of
any Federal Records Center where records from this system may be
stored.
Past and present patients of the National Institute of Neurological
Disorders and Stroke (NINDS) and the National Institute on Deafness and
Other Communication Disorders (NIDCD), and individuals being referred
for admission to the NIH Clinical Center.
Medical histories and diagnoses.
42 U.S.C. 241, 289a, 289c.
Clinical research on various diseases of the nervous system and
hearing, hearing loss, and communication disorders by HHS scientists
and their authorized collaborators, with the specific aim of improving
patient care and treatment by evaluating therapeutic procedures.
1. Clinical research data are made available to approved or
collaborating researchers, including HHS contractors and grantees.
Certain diseases and conditions, including infectious diseases, may be
reported to appropriate representatives of State or Federal Government
as required by State or Federal law.
2. Information may be used to respond to congressional inquiries
for constituents concerning admission to the NIH Clinical Center.
3. In the event of litigation where the defendant is: (a) The
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example in defending against a claim based upon an
individual's mental or physical condition and alleged to have arisen
because of activities of the Public Health Service in connection with
such individual, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice or other
appropriate Federal agency to enable that agency to present an
effective defense, provided that such disclosure is compatible with the
purpose for which the records were collected.
Records are stored in file folders and in computer-accessible
forms, bound notebooks, charts, graphs, and imaging films.
Records are retrieved by name.
1. Authorized users: Employees who maintain records in this system
are instructed to grant access only to HHS researchers and their
authorized collaborators.
2. Physical safeguards: Records are kept locked in file cabinets
when not in use and in locations which are locked during non-working
hours. Data stored in computer-accessible form is accessed through the
use of codes and key words known only to principal investigators or
authorized personnel.
3. Procedural safeguards: Records are returned to the files at the
close of each working day and are used only in the system location or
in a designated work area.
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
Assistant Director, Clinical Neurosciences Program, Building 10, Room
5N226, NIH, 9000 Rockville Pike, Bethesda, MD 20892
and
Acting Director of Intramural Research, NIDCD, Building 31, Room 3C02,
NIH, 9000 Rockville Pike, Bethesda, MD 20892
To determine if a record exists, contact:
Chief, Administrative Services Branch, NINDS, Building 31, Room 8A49,
NIH, 9000 Rockville Pike, Bethesda, MD 20892
or
Chief, Administrative Management Branch, NIDCD, Building 31, Room 3C21,
NIH, 9000 Rockville Pike, Bethesda, MD 20892
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine. An individual who requests
notification of or access to a medical/dental record shall, at the time
the request is made, designate in writing, a responsible representative
who will be willing to review the record and inform the subject
individual of its contents at the representative's discretion.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Contact the official at the address specified under notification
procedures above, and reasonably identify the record and specify the
information to be contested, the corrective action sought, and the
reasons for the correction, with supporting justification. The right to
contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
Referring and attending physicians, hospital records.
None.
09-25-0036
Extramural Awards and Chartered Advisory Committees: IMPAC (Grant/
Contract/Cooperative Agreement Information/Chartered Advisory Committee
Information), HHS/NIH/DRG and HHS/NIH/CMO.
None. [[Page 4249]]
Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892, and
Building 12, NIH Computer Center, 9000 Rockville Pike, Bethesda, MD
20892.
For information pertaining to the chartered advisory committees of
the National Institutes of Health: Building 31, Room 3B-55, 9000
Rockville Pike, Bethesda, MD 20892.
Applicant and Principal Investigators; Program Directors; NRSA
Trainees and Fellows; Research Career Awardees; and Chartered Advisory
Committee members.
Applications, awards, associated records, trainee appointments, and
current and historical information pertaining to chartered advisory
committees.
42 U.S.C. 241c, 58 Stat. 691c & d repealed.
(1) To support centralized grant programs of the Public Health
Service. Services are provided in the areas of grant application
assignment and referral, initial review, council review, award
processing and grant accounting. The data base is used to provide
complete, accurate, and up-to-date reports to all levels of management.
(2) To maintain communication with former fellows and trainees who
have incurred a payback obligation through the National Research
Service Award Program.
(3) To maintain current and historical information pertaining to
the establishment of chartered advisory committees of the National
Institutes of Health and the appointment or designation of their
members.
1. Disclosure may be made to the National Technical Information
Service (NTIS), Department of Commerce, for dissemination of scientific
and fiscal information on funded awards (abstract of research projects
and relevant administrative and financial data).
2. Disclosure may be made to the cognizant audit agency for
auditing.
3. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
4. Disclosure may be made to qualified experts not within the
definition of Department employees as prescribed in Department
Regulations for opinions as a part of the application review process.
5. Disclosure may be made to a Federal agency, in response to its
request, in connection with the letting of a contract, or the issuance
of a license, grant or other benefit by the requesting agency, to the
extent that the record is relevant and necessary to the requesting
agency's decision in the matter.
6. A record may be disclosed for a research purpose, when the
Department: (A) Has determined that the use or disclosure does not
violate legal or policy limitations under which the record was
provided, collected, or obtained; (B) has determined that the research
purpose (1) cannot be reasonably accomplished unless the record is
provided in individually identifiable form, and (2) warrants the risk
to the privacy of the individual that additional exposure of the record
might bring; (C) has required the recipient to (1) establish reasonable
administrative, technical, and physical safeguards to prevent
unauthorized use or disclosure of the record, (2) remove or destroy the
information that identifies the individual at the earliest time at
which removal or destruction can be accomplished consistent with the
purpose of the research project, unless the recipient has presented
adequate justification of a research or health nature for retaining
such information, and (3) make no further use or disclosure of the
record except (a) in emergency circumstances affecting the health or
safety of any individual, (b) for use in another research project,
under these same conditions, and with written authorization of the
Department, (c) for disclosure to a properly identified person for the
purpose of an audit related to the research project, if information
that would enable research subjects to be identified is removed or
destroyed at the earliest opportunity consistent with the purpose of
the audit, or (d) when required by law; (D) has secured a written
statement attesting to the recipient's understanding of, and
willingness to abide by these provisions.
7. The Department contemplates that it may contract with a private
firm for the purpose of collating, analyzing, aggregating or otherwise
refining records in this system. Relevant records will be disclosed to
such a contractor. The contractor will be required to maintain Privacy
Act safeguards with respect to such records.
8. Disclosure may be made to the grantee institution in connection
with performance or administration under the conditions of the award.
9. Disclosure may be made to the Department of Justice, or to a
court or other tribunal, from this system of records when (a) HHS, or
any component thereof; or (b) any HHS employee in his or her official
capacity; or (c) any HHS employee in his or her individual capacity
where the Department of Justice (or HHS, where it is authorized to do
so) has agreed to represent the employee; or (d) the United States or
any agency thereof where HHS determines that the litigation is likely
to affect HHS or any of its components, is a party to litigation or has
any interest in such litigation, and HHS determines that the use of
such records by the Department of Justice, court or other tribunal is
relevant and necessary to the litigation and would help in the
effective representation of the governmental party, provided, however
that in each case, HHS determines that such disclosure is compatible
with the purpose for which the records were collected.
Records are stored on discs and magnetic tapes.
Records are retrieved by name, application, grant or contract ID
number.
1. Authorized users: Employees who maintain records in this system
are instructed to grant regular access only to PHS extramural and
committee management staff. Other one-time and special access by other
employees is granted on a need-to-know basis as specifically authorized
by the system manager.
2. Physical safeguards: Physical access to DRG work areas is
restricted to DRG employees.
3. Procedural safeguards: Access to source data is strictly
controlled by files staff. Records may be removed from files only at
the request of the system manager or other authorized employee. Access
to computer files is controlled by the use of registered accounts,
registered initials, keywords, etc. The computer system maintains an
audit record of all attempted and successful requests for access.
These practices are in compliance with the standards of Chapter 45-
13 of [[Page 4250]] the HHS General Administration Manual,
``Safeguarding Records Contained in Systems of Records,'' supplementary
Chapter PHS hf: 45-13, and Part 6, ``ADP Systems Security,'' of the HHS
Information Resources Management Manual and the National Institute of
Standards and Technology Federal Information Processing Standards (FIPS
Pub. 41 and FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 4000-A-2, which allows records to be destroyed
when no longer needed for administrative purposes. Refer to the NIH
Manual Chapter for specific disposition instructions.
Chief, Information Systems Branch, Division of Research Grants,
Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892
and
For chartered advisory committees of the National Institutes of
Health:
NIH Committee Management Officer, Building 31, Room 3B-55, 9000
Rockville Pike, Bethesda, MD 20892.
To determine if a record exists write to:
Privacy Act Coordinator, Division of Research Grants, Westwood
Building, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892
and
For information pertaining to the chartered advisory committees of
the National Institutes of Health:
NIH Committee Management Officer, Building 31, Room 3B-55, 9000
Rockville Pike, Bethesda, MD 20892.
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Contact the official under notification procedures above, and
reasonably identify the record and specify the information to be
contested, and state the corrective action sought and the reasons for
the correction, with supporting justification. The right to contest
records is limited to information which is incomplete, irrelevant,
incorrect, or untimely (obsolete).
Individual, individual's educational institution and references.
None.
09-25-0042
Clinical Research: National Institute of Dental Research Patient
Records, HHS/NIH/NIDR.
None.
National Institutes of Health, Building 10, Room 1B01, 10 Center Drive
MSC 1190, Bethesda, MD 20892-1190.
Write to system manager at the address below for the address of the
Federal Records Center where records from this system may be stored.
Patients and other participants in current and past research
projects of the National Institute of Dental Research (NIDR).
Medical and dental histories, dental pathologies and therapies.
Sections 301, 401, 405 and 453 of the Public Health Service Act (42
U.S.C. 241, 281, 284, 285h). These sections establish the National
Institute of Dental Research and authorize the conduct and support of
dental oral research and related activities.
(1) To record the diagnosis and treatment of patients with diseases
of the mouth, tongue, teeth and surrounding tissues; (2) To record the
normal condition of the mouth, tongue, teeth and surrounding tissues of
individuals referred to the dental clinic; (3) To provide clinical data
for research into the etiology, treatment and prevention of oral
diseases; (4) For review and planning of the NIDR clinical program.
1. Disclosure may be made to HHS contractors, grantees and
collaborating researchers and their staff in order to accomplish the
clinical and research purposes for which the records are collected. The
recipients are required to maintain Privacy Act safeguards with respect
to these records.
2. Certain diseases and conditions, including infectious diseases,
may be reported to appropriate representatives of State or Federal
Government as required by State or Federal law.
3. Information may be used to respond to congressional inquiries
for constituents concerning admission to the NIH Clinical Center.
4. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example, when a claim is based upon an individual's
mental or physical condition and is alleged to have arisen because of
activities of the Public Health Service in connection with such
individual, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice to enable that
Department to present an effective defense, provided that such
disclosure is compatible with the purpose for which the records were
collected.
Records are stored in file folders.
Records are retrieved by name and hospital ID number.
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location and for the particular records maintained
in each project. Each site implements personnel, physical, and
procedural safeguards such as the following: [[Page 4251]]
1. Authorized users: Employees who maintain records in this system
are instructed to grant regular access only to dentists, physicians,
dental hygienists, dental assistants and other health care personnel
involved in the care and treatment of patients in the NIDR dental
clinic, and to referring professionals. Other one-time and special
access by other employees is granted on a need-to-know basis as
specifically authorized by the system manager.
2. Physical safeguards: Records are stored in a cabinet which is
locked at all times when not in use.
3. Procedural safeguards: Access is controlled by clerical staff of
the Dental Clinic during clinic hours, and by the Officer of the Day
when the clinic is closed.
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
National Institutes of Health, Deputy Clinical Director, NIDR, Building
10, Room 1N-113, 10 Center Drive MSC 1190, Bethesda, MD 20892-1190
To determine if a record exists contact:
NIDR Privacy Act Coordinator, Building 31, Room 2C-35, 10 Center Drive
MSC 1190, Bethesda, MD 20892-1190.
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine. An individual who requests
notification of or access to a medical/dental record shall, at the time
the request is made, designate in writing a responsible representative
who will be willing to review the record and inform the subject
individual of its contents at the representative's discretion.
A parent or guardian who requests notification of, or access to, a
child's or incompetent person's medical record shall designate a family
physician or other health professional (other than a family member) to
whom the record, if any, will be sent. The parent or guardian must
verify relationship to the child or incompetent person as well as his
or her own identity.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Contact the official under notification procedures above, and
reasonably identify the record and specify the information to be
contested, and state the corrective action sought and the reasons for
the correction, with supporting justification. The right to contest
records is limited to information which is incomplete, irrelevant,
incorrect, or untimely (obsolete).
Individual, parents or guardians.
None.
09-25-0044
Clinical Research: Sensory Testing Research Program, HHS/NIH/NIDR.
None.
National Institutes of Health, Building 10, Room 1-N-114, 10 Center
Drive, MSC 1190, Bethesda, MD 20892-1190.
Write to System Manager at the address below for the address of the
Federal Records Center where records from this system may be stored.
Infants, children and adults participating in the Sensory Testing
Research Program of the National Institute of Dental Research (NIDR).
Test results, extracts from medical records.
Sections 301, 401, 405 and 453 of the Public Health Service Act (42
U.S.C. 241, 281, 284, 285h). These sections establish the National
Institute of Dental Research and authorize the conduct and support of
dental and oral research and related activities.
(1) To record the medical/dental histories of individuals
participating in the Sensory Testing Research Program; (2) To record
the results of chemosensory tests of individuals participating in the
Sensory Testing Research Program; (3) For research on sensitivity to
oral nasal stimulation; (4) For review and planning of the Clinical
Investigations and Patient Care Branch program.
1. Disclosure may be made to HHS contractors, grantees, referring
health professionals and collaborating researchers and their staff in
order to accomplish the clinical and research purposes for which the
records are collected. The recipients are required to maintain Privacy
Act safeguards with respect to these records.
2. Certain diseases and conditions, including infectious diseases,
may be reported to appropriate representatives of State or Federal
Government as required by State or Federal law.
3. Information may be used to respond to congressional inquiries
for constituents concerning admission to the NIH Clinical Center.
4. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example, when a claim is based upon an individual's
mental or physical condition and is alleged to have arisen because of
activities of the Public Health Service in connection with such
individual, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice to enable that
Department to present an effective defense, provided that such
disclosure is compatible with the purpose for which the records were
collected.
Records are stored in file folders, data books and in a mini-
computer maintained by the NIDR Scientific Systems
Section. [[Page 4252]]
Records are retrieved by name, date of observation and age of
subject.
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location and for the particular records maintained
in each project. Each site implements personnel, physical and
procedural safeguards such as the following:
1. Authorized users: Employees who maintain records in this system
are instructed to grant regular access only to Clinical Investigations
Section staff, to scientist colleagues by invitation of the principal
investigator and to referring professionals. Other one time and special
access by other employees is granted on a need to know basis as
specifically authorized by the System Manager.
2. Physical safeguards: Records are stored in rooms which are
locked at all times when not in use. Computer terminals are in secured
areas. Access to computer file is controlled by software protection
codes associate with each site.
3. Procedural safeguards: Access is controlled by Clinical
Investigation Section staff.
These safeguards are in compliance with the standards of Chapter
45-13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and Part 6, ``ADP Systems Security,'' of the HHS Information Resources
Management Manual and the National Institute of Standards and
Technology Federal Information Processing Standards (FIPS Pub. 41 and
FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
Research Psychologist, Clinical Investigations, NIDR, Building 10,
Room 1N114, 10 Center Drive, MSC 1190, Bethesda, MD 20892-1190.
To determine if a record exists contact: NIDR Privacy Act
Coordinator, 31 Center Drive, MSC 2290, Building 31, Room 2C-35,
Bethesda, MD 20892-2290.
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine. An individual who requests
notification of or access to a medical/dental record shall, at the time
the request is made, designate in writing a responsible representative
who will be willing to review the record and inform the subject
individual of its contents at the representative's discretion.
A parent or guardian who requests notification of, or access to, a
child's or incompetent person's medical record shall designate a family
physician or other health professional (other than a family member) to
whom the record, if any, will be sent. The parent or guardian must
verify relationship to the child or incompetent person as well as his
or her own identity.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Contact the official under notification procedures above, and
reasonably identify the record and specify the information to be
contested, and state the corrective action sought and the reasons for
the correction, with supporting justification. The right to contest
records is limited to information which is incomplete, irrelevant,
incorrect, or untimely (obsolete).
Subject individual, cooperating clinician or health agency, family
members
None.
09-25-0054
Administration: Property Accounting, HHS/NIH/ORS.
None.
National Institutes of Health, Building 13, Room 2E43, 9000 Rockville
Pike, Bethesda, MD 20892
and
National Institutes of Health, Computer Center, Building 12, 9000
Rockville Pike, Bethesda, MD 20892
and
National Institutes of Health, Building 31, Room B3B16, 9000 Rockville
Pike, Bethesda, MD 20892
and
National Institute of Environmental Health Sciences, Office of
Facilities Engineering, 102-01, P.O. Box 12233, Research Triangle Park,
N.C. 27709
Employees of the National Institutes of Health who are issued tools
or card keys.
Property management.
5 U.S.C. 301; 5 U.S.C. 5901; 5 U.S.C. 7903; 40 U.S.C. 318a; 42
U.S.C. 241.
Used for tool and card keys issuance and control.
1. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
2. In the event that a system of records maintained by this agency
to carry out its functions indicates a violation or potential violation
of law, whether civil, criminal or regulatory in nature, and whether
arising by general statute or particular program statute, or by
regulation, rule or order issued pursuant thereto, the relevant records
in the system of records may be referred, as a routine use, to the
appropriate agency, whether federal, or foreign, charged with the
responsibility of investigating or prosecuting such violation or
charged with enforcing or implementing the statute, or rule, regulation
or order issued pursuant thereto.
3. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or [[Page 4253]] (c) any Department employee in his or her
individual capacity where the Justice Department has agreed to
represent such employee, the Department may disclose such records as it
deems desirable or necessary to the Department of Justice to enable
that Department to present an effective defense, provided that such
disclosure is compatible with the purpose for which the records were
collected.
Records are stored in file folders, and on magnetic media.
Records are retrieved by name.
1. Authorized users: Employees who maintain records in this system
are instructed to grant regular access only to officials whose duties
require use of the information. Other one time and special access by
other employees is granted on a need to know basis as specifically
authorized by the system manager.
2. Physical safeguards: Textual records are stored in offices which
are locked when not in use.
3. Procedural safeguards: Computer files are password protected.
This system of records will be protected according to the standards
of Chapter 45-13 of the HHS General Administration Manual,
``Safeguarding Records Contained in Systems of Records,'' supplementary
Chapter PHS hf: 45-13, and Part 6, ``ADP Systems Security,'' of the HHS
Information Resources Management Manual and the National Institute of
Standards and Technology Federal Information Processing Standards (FIPS
Pub. 41 and FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 1300-C-14, which allows records to be destroyed
after all listed credentials are accounted for or 3 months after the
return of credentials to the issuing office. Refer to the NIH Manual
Chapter for specific instructions.
For tools: National Institutes of Health, Administrative Officer,
DES, Building 13, Room 13/2E43, 9000 Rockville Pike, Bethesda, MD
20892.
For card keys:
National Institutes of Health, Chief, Crime Prevention Branch, Division
of Security Operations, ORS, Building 31, Room B3B16, 9000 Rockville
Pike, Bethesda, MD 20892.
National Institute of Environmental Health Sciences, Chief, Office of
Facilities Engineering, 102-01, P.O. Box 12233, Research Triangle Park,
NC 27709
Write to the System Manager to determine if a record exists. The
requester must also verify his or her identity by providing either a
notarization of the request or a written certification that the
requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Write to the official specified under notification procedures
above, and reasonably identify the record and specify the information
being contested, the corrective action sought, and your reasons for
requesting the correction, along with supporting information to show
how the record is inaccurate, incomplete, untimely or irrelevant. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
Data is obtained from the individual.
None.
09-25-0077
Biological Carcinogenesis Branch Human Specimen Program, HHS/NIH/
NCI.
None.
National Institutes of Health, Executive Plaza North, Rm. 540, 6130
Executive Blvd., Bethesda, MD 20892
and at private organizations under contract. Write to the system
manager for a list of current locations.
Cancer and other patients, and normal donors of biopsy and tumor
specimens, who are seen at clinically-oriented organizations under
contract to the National Cancer Institute. Both adults and children are
covered.
Medical history and diagnostic information about the donor,
information on the type of specimen, location of repository (if
specimen is stored before use), and distribution record.
42 U.S.C. 241, 281, 282: ``Research and Investigation,'' ``National
Cancer Institute,'' and ``Cancer Research and Other Activities.''
(1) For cancer research, using by-products of cancer treatment,
such as biopsy and tumor specimens that would normally be discarded, to
allow interpretation of experimental results; (2) To project future
research needs; (3) To monitor and evaluate the NCI distribution
system.
1. The Department contemplates that it may contract with a private
firm for storage and preservation of specimens. Records necessary for
identification, retrieval and research use will be disclosed to such a
contractor. The contractor will be required to comply with the
requirements of the Privacy Act with respect to such records.
2. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
3. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice to enable that
[[Page 4254]] Department to present an effective defense, provided that
such disclosure is compatible with the purpose for which the records
were collected.
Magnetic tape and discs.
Retrieved by name of donor and cross-referenced by identifying
number, procurement source, and various epidemiological
characteristics.
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location and for the particular records maintained
in each project. Each site implements personnel, physical and
procedural safeguards such as the following:
1. Authorized users: Employees who maintain records in this system
are instructed to grant regular access only to physicians, scientists
and support staff of the National Cancer Institute, or its contractors,
whose duties require the use of such information. Other one-time and
special access by other employees is granted on a need-to-know basis as
specifically authorized by the system manager.
2. Physical safeguards: Records, computers and computer terminals
are kept in limited access areas. Offices are locked during off-duty
hours. Input data for computer files is coded to avoid individual
identification.
3. Procedural safeguards: Access to manual files is strictly
controlled by files staff. Files may be accessed only at the request of
the system manager or other authorized employee. Access to computer
files is controlled through security codes known only to authorized
users.
Contractor compliance is assured through inclusion of Privacy Act
requirements in contract clauses, and through monitoring by contract
and project officers. Contractors who maintain records in this system
are instructed to make no disclosure of the records except as
authorized by the system manager.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and Part 6, ``ADP Systems Security,'' of the HHS Information Resources
Management Manual and the National Institute of Standards and
Technology Federal Information Processing Standards (FIPS Pub. 41 and
FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
Program Director, Research Resources, Biological Carcinogenesis Branch,
Division of Cancer Etiology, NCI, National Institutes of Health,
Executive Plaza North, Room 540, 6130 Executive Blvd., Bethesda, MD
20892
Write to System Manager to determine if a record exists. The
requester must also verify his or her identity by providing either a
notarization of the request or a written certification that the
requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
An individual who requests notification of or access to a medical/
dental record shall, at the time the request is made, designate in
writing a responsible representative who will be willing to review the
record and inform the subject individual of its contents at the
representative's discretion.
A parent or guardian who requests notification of, or access to, a
child's or incompetent person's medical record shall designate a family
physician or other health professional (other than a family member) to
whom the record, if any, will be sent. The parent or guardian must
verify relationship to the child or incompetent person as well as his
or her own identity.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Contact the official under notification procedures above, and
reasonably identify the record and specify the information to be
contested, and state your reasons for requesting the correction, along
with supporting information to show how the record is inaccurate,
incomplete, untimely or irrelevant. The right to contest records is
limited to information which is incomplete, irrelevant, incorrect, or
untimely (obsolete).
Specimen Report Form filled out by the organization providing
specimens.
None.
09-25-0078
Administration: Consultant File, HHS/NIH/NHLBI.
None.
National Institutes of Health, Westwood Building, 5333 Westbard Avenue,
Bethesda, MD 20892
List of consultants available for use in evaluation of National
Heart, Lung, and Blood Institute special grants and contracts.
Names and resumes.
42 U.S.C. 241(d), 281.
(1) To identify and select experts and consultants for program
reviews and evaluations. (2) For use in evaluation of NHLBI special
grants and contracts.
1. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
2. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to
[[Page 4255]] represent such employee, the Department may disclose such
records as it deems desirable or necessary to the Department of Justice
to enable that Department to present an effective defense, provided
that such disclosure is compatible with the purpose for which the
records were collected.
Computer disc and file folders.
Records are retrieved by name.
1. Authorized users: Data on computer files is accessed by keyword
known only to authorized users.
2. Physical safeguards: Rooms where records are stored are locked
when not in use.
3. Procedural safeguards: During regular business hours, rooms are
unlocked but are controlled by on-site personnel.
This system of records will be protected according to the standards
of Chapter 45-13 of the HHS General Administration Manual,
``Safeguarding Records Contained in Systems of Records,'' supplementary
Chapter PHS hf: 45-13, and Part 6, ``ADP Systems Security,'' of the HHS
Information Resources Management Manual and the National Institute of
Standards and Technology Federal Information Processing Standards (FIPS
Pub. 41 and FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 1100-G. Refer to the NIH Manual Chapter for
specific disposition instructions.
Chief, Review Branch, National Heart, Lung, and Blood Institute,
Westwood Building, Room 557A, 5333 Westbard Avenue, Bethesda, MD 20892
To determine if a record exists, contact:
Privacy Act Coordinator, NHLBI, National Institutes of Health, 31/5A10,
31 Center Drive, MSC 2490, Bethesda, MD 20892-2490
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Contact the official under notification procedures above, and
reasonably identify the record and specify the information to be
contested, and state the corrective action sought. The right to contest
records is limited to information which is incomplete, irrelevant,
incorrect, or untimely (obsolete).
Subject individual.
None.
09-25-0093
Administration: Authors, Reviewers, Editorial Board, and Members of
the Journal of the National Cancer Institute, HHS/NIH/NCI.
None.
Building 82, Room 239, 9030 Old Georgetown Road, Bethesda, MD 20814.
Write to System Manager at the address below for the address of the
Federal Records Center where records may be stored.
Authors and manuscript reviewers and members of the Journal of the
National Cancer Institute (JNCI) editorial board.
Accepted, rejected and pending manuscripts and review comments.
42 U.S.C. 241, 281.
Manuscript review by NCI staff of manuscripts submitted for
possible publication in the Journal of the National Cancer Institute or
JNCI Monographs.
1. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
2. Disclosure may be made to qualified experts not within the
definition of Department employees for opinions as a part of the review
of manuscripts.
3. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice to enable that
Department to present an effective defense, provided such disclosure is
compatible with the purpose for which the records were collected.
Records are stored in file folders.
Records are retrieved by name and manuscript number.
1. Authorized users: Employees who maintain records in this system
are instructed to grant access only to JNCI staff personnel, the Editor
in Chief, and members of the Board of Editors whose duties require the
use of such information.
2. Physical safeguards: Records are kept in a limited access area
where an employee is present at all times during working hours. The
Building is locked during off-duty hours.
3. Procedural safeguards: Access to manual files is tightly
controlled by office staff. Only authorized users may have access to
the files.
Information that identifies reviewers is not maintained in computer
files.
Records are retained and disposed of under the authority of the NIH
Records [[Page 4256]] Control Schedule contained in NIH Manual Chapter
1743, Appendix 1--``Keeping and Destroying Records'' (HHS Records
Management Manual, Appendix B-361), item 8000-A-1(b), which allows
records to be kept for a maximum period of one year after year in which
published or presented. Refer to the NIH Manual Chapter for specific
disposition instructions.
System Specialist, Scientific Publications Branch, Building 82, Room
239, 9030 Old Georgetown Road, Bethesda, MD 20814.
Write to System Manager to determine if a record exists. The
requester must also verify his or her identity by providing either a
notarization of the request or a written certification that the
requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Contact the official under notification procedures above, and
reasonably identify the record and specify the information to be
contested, and state the corrective action sought and the reasons for
the correction, with supporting justification. The right to contest
records is limited to information which is incomplete, irrelevant,
incorrect, or untimely (obsolete).
Authors and reviewers.
None.
09-25-0099
Clinical Research: Patient Medical Records, HHS/NIH/CC.
None.
National Institutes of Health, Medical Record Department, 10 Center
Drive MSC 1192, Bethesda, MD 20892-1192.
and at private organizations under contract. Write to the system
manager for a list of current locations.
Registered Clinical Center patients. Some individuals not
registered as patients but seen in Clinical Center for diagnostic
tests.
Medical treatment records.
42 U.S.C. 241, 248: ``Research and Investigation,'' and
``Hospitals, Medical Examination, and Medical Care.''
(1) To provide a continuous history of the treatment afforded
individual patients in the Clinical Center; (2) To provide a data base
for the clinical research conducted within the hospital.
1. Information may be used to respond to Congressional inquiries
for constituents concerning their admission to NIH Clinical Center.
2. Social Work Department may give pertinent information to
community agencies to assist patients or their families.
3. Referring physicians receive medical information for continuing
patient care after discharge.
4. Information regarding diagnostic problems, or having unusual
scientific value may be disclosed to appropriate medical or medical
research organizations or consultants in connection with treatment of
patients or in order to accomplish the research purposes of this
system. For example, tissue specimens may be sent to the Armed Forces
Institute of Pathology; X-rays may be sent for the opinion of a
radiologist with extensive experience in a particular kind of
diagnostic radiology. The recipients are required to maintain Privacy
Act safeguards with respect to these records.
5. Records may be disclosed to representatives of the Joint
Commission on Accreditation of Hospitals conducting inspections to
ensure that the quality of Clinical Center medical record-keeping meets
established standards.
6. Certain diseases and conditions, including infectious diseases,
may be reported to appropriate representatives of State or Federal
Government as required by State or Federal law.
7. Medical information may be disclosed to tumor registries for
maintenance of health statistics.
8. The Department contemplates that it may contract with a private
firm for transcribing, updating, copying, or otherwise refining records
in this system. Relevant records will be disclosed to such a
contractor. The contractor will be required to comply with the
requirements of the Privacy Act with respect to such records.
9. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department of any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example in defending against a claim based upon an
individual's mental or physical condition and alleged to have arisen
because of activities of the Public Health Service in connection with
such individual, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice to enable that
agency to present an effective defense, provided that such disclosure
is compatible with the purpose for which the records were collected.
10. (a). PHS may inform the sexual and/or needle-sharing partner(s)
of a subject individual who is infected with the human immunodeficiency
virus (HIV) of their exposure to HIV, under the following
circumstances: (1) The information has been obtained in the course of
clinical activities at PHS facilities carried out by PHS personnel or
contractors; (2) The PHS employee or contractor has made reasonable
efforts to counsel and encourage the subject individual to provide the
information to the individual's sexual or needle-sharing partner(s);
(3) The PHS employee or contractor determines that the subject
individual is unlikely to provide the information to the sexual or
needle-sharing partner(s) or that the provision of such information
cannot reasonably be verified; and (4) The notification of the
partner(s) is made, whenever possible, by the subject individual's
physician or by a professional counselor and shall follow standard
counseling practices.
(b). PHS may disclose information to State or local public health
departments, to assist in the notification of the subject individual's
sexual and/or needle-sharing partner(s), or in the verification that
the subject individual has notified such sexual or needle-sharing
partner(s). [[Page 4257]]
Records are stored in file folders and/or on microfiche, and on
computer tapes.
Records are retrieved by unit number and patient name.
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location and for the particular records maintained
in each project. Each site implements personnel, physical, and
procedural safeguards such as the following:
1. Authorized users: Employees maintaining records in this system
are instructed to grant regular access only to physicians and dentists
and other health care professionals officially participating in patient
care, to contractors, or to NIH researchers specifically authorized by
the system manager.
2. Physical safeguards: All record facilities are locked when
system personnel are not present.
3. Procedural safeguards: Access to files is strictly controlled by
the system manager. Records may be removed only by system personnel
following receipt of a request signed by an authorized user. Access to
computerized records is controlled by the use of security codes known
only to the authorized user. Codes are user- and function-specific.
Contractor compliance is assured through inclusion of Privacy Act
requirements in contract clauses, and through monitoring by contract
and project officers. Contractors who maintain records in this system
are instructed to make no disclosure of the records except as
authorized by the system manager.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and Part 6, ``ADP Systems Security,'' of the HHS Information Resources
Management Manual and the National Institute of Standards and
Technology Federal Information Processing Standards (FIPS Pub. 41 and
FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-E-22, which allows records to be kept until
no longer needed for scientific reference. Refer to the NIH Manual
Chapter for specific disposition instructions.
Chief, Medical Record Department, National Institutes of Health, 10
Center Drive MSC 1192, Bethesda, MD 20892-1192.
To determine if a record exists, write to the system manager at the
above address. The requester must provide tangible proof of identify,
such as a driver's license. If no identification papers are available,
the requester must verify his or her identity by providing either a
notarization of the request or a written certification that the
requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
An individual who requests notification of or access to a medical/
dental record shall, at the time the request is made, designate in
writing a responsible representative who will be willing to review the
record and inform the subject individual of its contents at the
representative's discretion. The representative may be a physician, or
other health professional, or other responsible individual. The subject
individual will be granted direct access unless it is determined that
such access is likely to have an adverse effect on him or her. In that
case, the medical/dental record will be sent to the designated
representative.
The individual will be informed in writing if the record is sent to
the representative.
A parent or guardian who requests notification of or access to a
child's/incompetent person's record shall designate a family physician
or other health professional (other than a family member) to whom the
record, if any, will be sent. The parent or guardian must verify
relationship to the child/incompetent personas well as his/her own
identity.
Same as notification procedures. Requesters should also reasonably
identify the specific reports and related dates pertaining to the
information to be released. There may be a fee for reproducing more
than 20 pages of material. Individuals may also request listings of
accountable disclosures that have been made of their records, if any.
Contact the system manager and reasonably identify the record and
specify the information to be contested, and state the corrective
action sought and your reasons for requesting the correction, along
with supporting information to show how the record is inaccurate,
incomplete, untimely or irrelevant. The right to contest records is
limited to information which is incomplete, irrelevant, incorrect, or
untimely (obsolete).
Referring physicians, other medical facilities (with patient's
consent), patients, relatives of patients.
None.
09-25-0102
Grants Associates Program Working Files, HHS/NIH/OER.
None.
Extramural Staff Training Office, National Institutes of Health,
Building 31, Room 5B35, 9000 Rockville Pike, Bethesda, Maryland 20892.
Grants Associates Training Program Participants.
Applications, curriculum vitae, reports on assignments, critiques
of courses, supervisors endorsements, summary of assignments, and
correspondence.
5 U.S.C. Part III; 42 U.S.C. 241c.
1. Assisting participants in obtaining maximum benefits from the
Program;
2. Providing information to current Grants Associates about
assignments and opportunities;
3. Providing resumes to other HHS components for possible
employment of the Grants Associates trainee;
4. Reviewing and evaluating the Programs. [[Page 4258]]
1. Disclosure may be made to the Office of Personnel Management for
salary approval.
2. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
3. Disclosure may be made to the Department of Justice, or to a
court or other tribunal from this system of records, when (a) HHS, or
any component thereof; or (b) any HHS employee in his or her official
capacity; or (c) any HHS employee in his or her individual capacity
where the Department of Justice (or HHS, where it is authorized to do
so) has agreed to represent the employee; or (d) the United States or
any agency thereof where HHS determines that the litigation is likely
to affect HHS or any of its components, is a party to litigation or has
an interest in such litigation, and HHS determines that the use of such
record by the Department of Justice, the court or the tribunal is
relevant and necessary to the litigation and would help in the
effective representation of the governmental party, provided, however,
that in each case HHS has determined that such disclosure is compatible
with the purpose for which the records were collected.
Records are stored in file folders.
Records are retrieved by name.
1. Authorized users: Access limited to system manager and staff.
Other one-time and special access by other employees is granted on a
need to know basis as specifically authorized by the system manager.
2. Physical safeguards: Records are stored in local cabinets in
offices which are locked during off-duty hours.
3. Procedural safeguards: Access to the files is strictly
controlled by employees who maintain the files. Records may be removed
from files only at the request of the system manager or other
authorized personnel.
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 2300-320-1, which allows records to be destroyed
after a maximum period of 2 years after completion of grants associate
appointment.
Director, HSA Development Programs, NIH, Building 31, Room 5B35, 9000
Rockville Pike, Bethesda, MD 20892.
Write to the System Manager to determine if a record exists. The
requester must also verify his or her own identity by providing either
a notarization of the request or a written certification that the
requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the Act
subject to a five thousand dollar fine.
Same as notification procedure above. Requesters should also
reasonably specify the record contents being sought. Individuals may
also request listings of accountable disclosures that have been made of
their records, if any.
Write to the official specified under the notification procedures
above, and reasonably identify the record and specify the information
being contested, the corrective action sought and your reason for
requesting the correction, along with supporting information showing
how the record is inaccurate, incomplete, untimely, irrelevant. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
The subject individual, educational institutions attended by the
individual, personal references; and the Office of Personnel
Management.
None.
09-25-0105
Administration: Health Records of Employees, Visiting Scientists,
Fellows, Contractors and Others who Receive Medical Care Through the
Employee Health Unit, HHS/NIH/ORS.
None.
Building 10 and 13, NIH, 9000 Rockville Pike, Bethesda, MD 20892;
Westwood Building, 5333 Westbard Ave., Bethesda, MD 20892;
Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857;
Rocky Mountain Laboratories, Hamilton, Montana 59840.
Employees, fellows, visiting scientists, relatives of inpatients,
visitors, contractors, and others who receive medical care through the
Employee Health Unit.
Medical records.
5 U.S.C. 7901.
1. For medical treatment;
2. Upon researcher request with individual's written permission,
release of record for research purposes to medical personnel;
3. Upon request by HHS personnel offices for determination of
fitness for duty, and for disability retirement and other separation
actions;
4. For monitoring personnel to assure that safety standards are
maintained.
1. Disclosure may be made to Federal, State, and local government
agencies for adjudication of benefits under workman's compensation, and
for disability retirement and other separation actions.
2. To district office of OPEC, Department of Labor with copies to
the U.S. Office of Personnel Management for processing of disability
retirement and other separation actions.
3. Upon non-HHS agency request, for examination to determine
fitness for duty with copies to requesting agency and to the U.S.
Office of Personnel Management.
4. Disclosure may be made to a congressional office from the record
of an individual in response to any inquiry from the congressional
office made at the request of the individual.
5. The Department of Health and Human Services (HHS) may disclose
information from this system of records to the Department of Justice,
or to a court or other tribunal, when (a) HHS, or any component
thereof; or (b) any HHS employee in his or her official capacity; or
(c) any HHS employee in his or her individual capacity where the
[[Page 4259]] Department of Justice (or HHS, where it is authorized to
do so) has agreed to represent the employee; or (d) the United States
or any agency thereof where HHS determines that the litigation is
likely to affect HHS or any of its components, is a party to litigation
or has any interest in such litigation, and HHS determines that the use
of such records by the Department of Justice, court or other tribunal
is relevant and necessary to the litigation and would help in the
effective representation of the governmental party, provided, however
that in each case, HHS determines that such disclosure is compatible
with the purpose for which the records were collected.
Records are stored in file folders.
Records are retrieved by name and SSN.
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location and for the particular records maintained
in each project.
Each site implements personnel, physical and procedural safeguards
such as the following:
1. Authorized users: Access is limited to authorized personnel
(system manager and staff; Occupational Medicine Service staff; and
personnel and administrative officers with need for information for
fitness for duty, disability, and other similar determinations.)
2. Physical safeguards: Files are maintained in locked cabinets.
3. Procedural safeguards: Access to files is strictly controlled by
authorized staff.
Records are retained and disposed of under the authority of the NIH
Records Control Schedule, Manual Chapter 1743 (HHS Records Management
Manual, Appendix B-361), item 2300-792-3.
Deputy Director, Division of Safety, NIH, Building 31, Room 1C02, 9000
Rockville Pike, Bethesda, MD 20892
Chief, Rocky Mountain Operations Branch, Rocky Mountain Laboratories
(RMS), National Institutes of Health, Hamilton, MT 59840.
Contact System Manager at appropriate treatment location listed
above, to determine if a record exists. The requester must also verify
his or her identity by providing either a notarization of the request
or a written certification that the requester is who he or she claims
to be and understands that the knowing and willful request for
acquisition of a record pertaining to an individual under false
pretenses is a criminal offense under the Act, subject to 5,000 dollar
fine.
Same as notification procedures. Requester should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Write to the official specified under notification procedures
above, and reasonably identify the record and specify the information
being contested, the corrective action sought, and your reasons for
requesting the correction, along with supporting information to show
how the record is inaccurate, incomplete, untimely or irrelevant. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
Records contain data resulting from clinical and preventative
services provided at treatment location, and data received from
individual.
None.
09-25-0106
Administration: Office of the NIH Director and Institute/Center/
Division Correspondence Records, HHS/NIH/OD.
None.
Executive Secretariat, Office of the Director, Building 1, Room B1-55,
9000 Rockville Pike, Bethesda, MD 20892
Office of Legislative Policy and Analysis, Office of the Director,
Building 1, Room 244, 9000 Rockville Pike, Bethesda, MD 20892
and
Institute/Center/Division Staff Offices that retain correspondence
files. Write to the appropriate system manager listed in Appendix I for
a list of current locations and for the address of the Federal Records
Center where records are stored.
Individuals who have contacted the NIH Director or his/her
subordinates, or have been contacted in writing by one of these
officials.
Correspondence and other supporting documents.
5 USC 301 44 USC 3101.
1. To control and track all correspondence documents addressed or
directed to the NIH Director or his/her subordinates, as well as
documents/supporting documents initiated by them, in order to assure
timely and appropriate attention.
2. Incoming correspondence and supporting documentation is
forwarded to other HHS components when a response from them is
warranted.
1. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
2. Disclosure may be made from this system of records by the
Department of Health and Human Services (HHS) to the Department of
Justice, or to a court or other tribunal, when (a) HHS, or any
component thereof; or (b) any HHS employee in his or her official
capacity; or (c) any HHS employee in his or her individual capacity
where the Department of Justice (or HHS, where it is authorized to do
so) has agreed to represent the employee; or (d) the United States or
any agency thereof where HHS determines that the litigation is likely
to affect HHS or any of its components, is a party to litigation or has
any interest in such litigation, and HHS determines that the use of
such records by the Department of Justice, court or other tribunal is
relevant and necessary to the litigation and would help in the
effective representation of the governmental party, provided, however
that in each case, HHS determines that such disclosure is compatible
with the purpose for which the records were collected. [[Page 4260]]
Records are stored by computer index, optical image and in file
folders.
Records are retrieved by name, document number, date, and subject.
1. Authorized users: Access to textual records is limited to
authorized personnel (system managers and staff).
2. Physical safeguards. Physical access to records is restricted to
authorized personnel.
3. Procedural safeguards: Access to textual records is strictly
controlled by system managers and staff. Records may be removed from
files only at the request of system managers or other authorized
employees. Computer files are password protected.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and Part 6, ``ADP Systems Security,'' of the HHS Information Resources
Management Manual and the National Institute of Standards and
Technology Federal Information Processing Standards (FIPS Pub. 41 and
FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 1700-C, which allows records to be kept for a
maximum period of 6 years. Refer to the NIH Manual Chapter for specific
disposition instructions.
System Managers are listed in Appendix I; each maintains full
responsibility for their specific correspondence system.
To determine if a record exists, write to the appropriate system
manager as listed in Appendix I. The requester must also verify his or
her identity by providing either a notarization of the request or a
written certification that the requester is who he or she claims to be
and understands that the knowing and willful request for acquisition of
a record pertaining to an individual under false pretenses is a
criminal offense under the Act, subject to a five thousand dollar fine.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Contact the official under notification procedures above, and
reasonably identify the record and specify the information to be
contested, and state the corrective action sought and the reasons for
the correction. The right to contest records is limited to information
which is incomplete, irrelevant, incorrect, or untimely (obsolete).
Records are derived from incoming and outgoing correspondence.
None.
Appendix I: System Managers
Director, Executive Secretariat, Office of the Director, Building 1,
Room B1-55, 9000 Rockville Pike, Bethesda, MD 20892
Acting Associate Director, Office of Legislative Policy and
Analysis, Office of the Director, Building 1, Room 244, 9000
Rockville Pike, Bethesda, MD 20892
National Cancer Institute (NCI), Secretary to the Director, Building
31, Room 11A48, Bethesda, MD 20892
National Heart, Lung and Blood Institute (NHLBI), Secretary to the
Director, OD, Director's Office, Building 31, Room 5A52, 31 Center
Drive, MSC 2486, Bethesda, MD 20892-2486
National Institute of Diabetes and Digestive and Kidney (NIDDK),
Director, OHRR, Building 31, Room 9A04, Bethesda, MD 20892
National Institute of Environmental Health Sciences (NIEHS),
Executive Secretariat, PO Box 12233, South Campus, Building 2, Room
B201, Research Triangle Park, NC 27709
National Eye Institute (NEI), Administrative Officer, Building 31,
Room 6A19, 31 Center Drive MSC 2510, Bethesda, MD 20892-2510
National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS), Director, Office of Scientific and Health
Communications, Building 31, Room 4C05, Bethesda, MD 20892
National Institute on Deafness and Other Communication Disorders
(NIDCD), Chief, Administrative Management Branch, Building 31, Room
3C21, Bethesda, MD 20892
National Institute of General Medical Science (NIGMS), Secretary to
the Director, Westwood Building, Room 926, Bethesda, MD 20892
National Library of Medicine (NLM), Executive Assistant, Office of
the Director, Building 38, Room 2E17, Bethesda, MD 20894
Fogarty International Center (FIC), Secretary to the Director,
Building 31, Room B2C06, Bethesda, MD 20892
Office of Aides Research (OAR), Special Assistant for Liaison
Activities, Building 31, Room 5C12, Bethesda, MD 20892
National Institute on Drug Abuse (NIDA), Executive Secretariat, Room
10-15, Parklawn Building, Rockville, MD 20857
National Institute on Alcohol Abuse and Alcoholism (NIAAA),
Executive Secretariat, Willco Building, Suite 400, 6000 Executive
Blvd. MSC 7003, Bethesda, MD 20892-7003
National Institute of Mental Health (NIMH), Executive Secretariat,
Room 17C-25, Parklawn Building, Rockville, MD 20857
Washington National Records Center, 4205 Suitland Road, Washington,
DC 20857
09-25-0112
Grants and Cooperative Agreements: Research, Research Training,
Fellowship and Construction Applications and Related Awards, HHS/NIH/
OD.
None.
See Appendix I.
Grant applicants and Principal Investigators; Program Directors;
Institutional and Individual Fellows; Research Career Awardees; and
other employees of Applicant and/or grantee institutions.
Grant and cooperative agreement applications and review history,
awards, financial records, progress reports, payback records, and
related correspondence.
``Research and Investigation,'' ``Appointment and Authority of the
Directors of the National Research Institutes,'' ``National Institute
of Mental Health,'' ``National Institute on Drug Abuse,'' ``National
Institute on Alcohol Abuse and Alcoholism,'' ``National Cancer
Institute,'' ``National Heart, Lung and Blood Institute,'' ``National
Institute of Diabetes, and Digestive and Kidney Diseases,'' ``National
Institute of Arthritis and Musculoskeletal and Skin Diseases,''
``National Institute on Aging,'' ``National Institute on Allergy and
Infectious Diseases,'' ``National Institute of Child Health and Human
Development,'' ``National Institute of [[Page 4261]] Dental Research,''
``National Eye Institute,'' ``National Institute of Neurological
Disorders and Stroke,'' National Institute of General Medical
Sciences,'' ``National Institute of Environmental Health Sciences,''
``National Institute on Deafness and Other Communication Disorders,''
``National Institute of Nursing Research,'' and the ``National Library
of Medicine,'' of the Public Health Service Act. (42 U.S.C. 241, 284,
285, 285(b), (c), (d), (e), (f), (g), (h), (i), (j), (k), (l), (m),
286b-286b-7.
1. Information provided is used by NIH staff for review, award, and
administration of grant programs.
2. Information is also used to maintain communication with former
fellows who have incurred an obligation through the National Research
Service Award Program.
3. Staff may also use curriculum vitae to identify candidates who
may serve as ad hoc consultants or committee and council members in the
grant peer review process.
1. Disclosure may be made of assignments of research investigators
and project monitors to specific research projects to the National
Technical Information Service (NTIS), Department of Commerce, to
contribute to the Smithsonian Science Information Exchange, Inc.
2. Disclosure may be made to the cognizant audit agency for
auditing.
3. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice to enable that
Department to present an effective defense, provided such disclosure is
compatible with the purpose for which the records were collected.
4. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
5. Disclosure may be made to qualified experts not within the
definition of Department employees as prescribed in Department
Regulations, 45 CFR 56.2, for opinions as a part of the application
review and award administration processes.
6. Disclosure may be made to a Federal agency, in response to its
request, in connection with the letting of a contract, or the issuance
of a license, grant or other benefit by the requesting agency, to the
extent that the record is relevant and necessary to the requesting
agency's decision on the matter.
7. A record may be disclosed for a research purpose, when the
Department: (A) Has determined that the use or disclosure does not
violate legal or policy limitations under which the record was
provided, collected; or obtained; (B) has determined that the research
purpose (1) cannot be reasonably accomplished unless the record is
provided in individually identifiable form, and (2) warrants the risk
to the privacy of the individual that additional exposure of the record
might bring; (C) has required the recipient to (1) establish reasonable
administrative, technical, and physical safeguards to prevent
unauthorized use or disclosure of the record, (2) remove or destroy the
information that identifies the individual at the earliest time at
which removal or destruction can be accomplished consistent with the
purpose of the research project, unless the recipient has presented
adequate justification of a research or health nature for retaining
such information, and (3) make no further use or disclosure of the
record except (a) in emergency circumstances affecting the health or
safety of any individual, (b) for use in another research project,
under these same conditions, and with written authorization of the
Department, (c) for disclosure to a properly identified person for the
purpose of an audit related to the research project, if information
that would enable research subjects to be identified is removed or
destroyed at the earliest opportunity consistent with the purpose of
the audit, or (d) when required by law; (D) has secured a written
statement attesting to the recipient's understanding of, and
willingness to abide by these provisions.
8. Disclosure may be made to a private firm for the purpose of
collating, analyzing, aggregating or otherwise refining records in a
system. Relevant records will be disclosed to such a contractor. The
contractor shall be required to maintain Privacy Act safeguards with
respect to such records;
9. Disclosure may be made to the grantee institution in connection
with the review of an application or performance or administration
under the terms and conditions of the award, or in connection with
problems that might arise in performance or administration if an award
is made on a grant proposal.
10. Disclosure may be made to the profit institution's president or
official responsible for signing the grant application in connection
with the review or award of a grant application and in connection with
the administration and performance of a grant under the terms and
conditions of the awards.
Disclosures pursuant to 5 U.S.C. 552a(b)(12): Disclosures may be
made from this system to ``consumer reporting agencies'' as defined in
the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) or the Federal
Claims Collection Act of 1966 (31 U.S.C. 3701(a)(3)).
The Department may disclose to consumer reporting agencies
information on individuals who have failed to meet payback obligations
incurred under awards made under authority of the National Research
Service Awards Program (41 U.S.C. 289l-1). Information disclosed
includes data identifying the individual, the amount, status and
history of the obligation, and that the obligation arose from an award
made under the National Research Service Awards Program.
Stored in file folders, on computer tapes and discs, cards and in
notebooks.
Retrieved by name and grant number.
A variety of physical and procedural safeguards are implemented, as
appropriate, at the various locations of this system:
1. Authorized users: Employees who maintain records in this system
are instructed to grant regular access only to officials whose duties
require use of the information. These officials include review groups,
grants management staff, other extramural program staff, health
scientist administrators, data processing and analysis staff and
management officials with oversight responsibilities for extramural
programs. Other one-time and special access is granted on an individual
basis as specifically authorized by the system manager. Authorization
for access to [[Page 4262]] computerized files is controlled by the
system manager or designated official and is granted on a need-to-know
basis. Lists of authorized users are maintained.
2. Physical safeguards: Secured facilities, locked rooms, locked
cabinets, personnel screening; records stored in order of grant numbers
which are randomly assigned.
3. Procedural safeguards: Access to file rooms and files is
strictly controlled by files staff or other designated officials;
charge-out cards identifying users are required for each file used;
inactive records are transferred to controlled storage in Federal
Records Center in a timely fashion; retrieval of records from inactive
storage is controlled by the system manager or designated official and
by the NIH Records Management Officer; computer files are password
protected and access is actively monitored by the Computer Center to
prevent abuse. Employees are given specialized training in the
requirements of the Privacy Act as applied to the grants program.
These particular safeguards are developed in accordance with
Chapter 45-13, ``Safeguarding Records Contained in Systems of
Records,'' of the HHS General Administration Manual, supplementary
Chapter PHS hf: 45-13, and Part 6, ``ADP Systems Security'', of the HHS
Information Resources Management Manual and the National Institute of
Standards and Technology Federal Information Processing Standards (FIPS
Pub. 41 and FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), items: 4000-B-1; 4000-B-4; 4000-C-1 and, 4600-D-1.
Refer to the NIH Manual Chapter for specific disposition instructions.
See Appendix II.
Write to Official at the address specified in Appendix II to
determine if a record exists. The requester must also verify his or her
identity by providing either a notarization of the request or a written
certification that the requester is who he or she claims to be and
understands that the knowing and willful request for acquisition of a
record pertaining to an individual under false pretenses is a criminal
offense under the Act, subject to a five thousand dollar fine.
Write to the official at the address specified in Appendix IV to
obtain access to a record, and provide the same information as is
required under the Notification Procedures above. Requesters should
also reasonably specify the record contents being sought.
Individuals may also request listings of accountable disclosures
that have been made of their records, if any.
Contact the official at the address specified in Appendix II, and
reasonably identify the record and specify the information being
contested, the corrective action sought, and your reasons for
requesting the correction, along with supporting information to show
how the record is inaccurate, incomplete, untimely or irrelevant. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect or untimely (obsolete).
Information by applicant; supplemented by outside reviewers and
internal staff.
None.
Appendix I: System Location
National Cancer Institute, Executive Plaza South, Suite T-42, 6120
Executive Boulevard, Bethesda, MD 20892
National Heart, Lung, and Blood Institute, Westwood Building, Room
4A09, 5333 Westbard Avenue Bethesda, MD 20892
National Library of Medicine, Building 38A, Room 5N509, 8600
Rockville Pike, Bethesda, MD 20894
National Institute of Allergy and Infectious Diseases, Chief, Grants
Management Branch, DEA, Solar Bldg., Room 4C-09, 6003 Executive
Blvd., Rockville, MD 20892
National Institute of Allergy and Infectious Diseases, Chief,
Management Information Systems Section, FMISB, OAM, Solar Building,
Room 4A-03, 6003 Executive Blvd., Rockville, MD 20892
National Institute of Diabetes and Digestive and Kidney Diseases,
Westwood Building, Room 610, 5333 Westbard Avenue, Bethesda, MD
20892
National Institute of Arthritis and Musculoskeletal and Skin
Diseases, Westwood Building, Room 5A03, 5333 Westbard Avenue,
Bethesda, MD 20892
National Institute of Child Health and Human Development, 6100
Executive Blvd., Room 7A07, Bethesda, MD 20892
National Institute on Aging, Gateway Building, Room 2N-212, 7201
Wisconsin Avenue, Bethesda, MD 20892
National Institute of Dental Research, Grants Management Officer,
Natcher Building, Room 4AS-55, 45 Center Drive, MSC 6402, Bethesda,
MD 20892-6402
National Institute of Environmental Health Sciences, Grants
Management Officer, Building 2, Room 204, 104 Alexander Drive,
Research Triangle Park, NC 27709
National Institute of General Medical Sciences, Grants Management
Officer, Natcher Building, Room 2AN52, 9000 Rockville Pike,
Bethesda, MD 20892
National Institute of Neurological Disorders and Stroke, Federal
Building, Room 10A12, 7550 Wisconsin Avenue, Bethesda, MD 20892
National Institute on Deafness and Other Communication Disorders,
Executive Plaza South, Room 400B, 6120 Executive Boulevard,
Rockville, MD 20852
National Eye Institute, Executive Plaza South, Room 350, 6120
Executive Boulevard, Bethesda, MD 20892
National Center for Research Resources, Westwood Building, Room 853,
5333 Westbard Avenue, Bethesda, MD 20892
National Institute of Nursing Research, Building 45, Room 3AN32 MSC
6301, Bethesda, MD 20892-6301
Fogarty International Center, Building 31, Room B2C32, 9000
Rockville Pike, Bethesda, MD 20892
Washington National Records Center, 4205 Suitland Road, Suitland, MD
20409
National Institute on Drug Abuse, Grants Management Branch, Room 8A-
54, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857
National Institute on Alcohol Abuse and Alcoholism, Grants
Management Branch, Willco Building, Suite 504, 6000 Executive Blvd.
MSC 7003, Bethesda, MD 20892-7003
National Institute of Mental Health, Grants Management Branch, ORM,
Room 7C-15, Parklawn Building, 5600 Fishers Lane, Rockville, MD
20857
Appendix II: System Manager and Address
National Cancer Institute, Grants Management Analyst, Executive
Plaza South, Suite 234, 6120 Executive Boulevard, Bethesda, MD 20892
National Heart, Lung, and Blood Institute, Chief, Grants Operations
Branch, Division of Extramural Affairs, Westwood Building, Room
4A10, 5333 Westbard Avenue, Bethesda, MD 20892
National Library of Medicine, Associate Director for Extramural
Programs, Building 38A, Room 5N505, 8600 Rockville Pike, Bethesda,
MD 20894
National Institute of Allergy and Infectious Diseases, Chief, Grants
Management Branch, DEA, Solar Bldg., Room 4B-21, 6003 Executive
Blvd., Bethesda, MD 20892
National Institute of Allergy and Infectious Diseases, Chief,
Management Information Systems Section, FMISB, OAM, Solar Building,
Room 4A-03, 6003 Executive Blvd., Bethesda, MD 20892
National Institute of Arthritis and Musculoskeletal and Skin
Diseases, Grants Management Officer, Westwood Building, Room 407,
5333 Westbard Avenue, Bethesda, MD 20892
National Institute of Diabetes and Digestive and Kidney Diseases,
Grants Management Officer, Room 637, Westwood Building, 5333
Westbard Avenue, Bethesda, MD 20892 [[Page 4263]]
National Institute of Child Health and Human Development, Chief,
Office of Grants & Contracts, 6100 Executive Blvd., Room 8A01,
Bethesda, MD 20892
National Institute on Aging, Grants Management Officer, Gateway
Building, Room 2N-212, 7201 Wisconsin Avenue, Bethesda, MD 20892
National Institute of Dental Research, Grants Management Officer,
NIDR, Natcher Building, Room 4AS-55, 45 Center Drive MSC 6402,
Bethesda, MD 20892-6402
National Institute of Environmental Health Sciences, Grants
Management Officer, Building 2, Room 204, 104 Alexander Drive,
Research Triangle Park, NC 27709
National Institute of General Medical Sciences, Grants Management
Officer, NIGMS, Natcher Building, Room 2AN24, 9000 Rockville Pike,
Bethesda, MD 20892
National Institute of Neurological Disorders and Stroke, Grants
Management Officer, Federal Building, Room 1004A, Bethesda, MD 20892
National Institute on Deafness and Other Communication Disorders,
Grants Management Officer, Executive Plaza South, Room 400B, 6120
Executive Boulevard, Rockville, MD 20852
National Institute of Nursing Research, Grants Management Officer,
Building 45, Room 3AN32 MSC 6301, Bethesda, MD 20892-6301
National Eye Institute, Grants Management Officer, Executive Plaza
South, Room 350, 6120 Executive Boulevard, Bethesda, MD 20892
National Center for Research Resources, Director, Office of Grants
and Contracts Management, Westwood Building, Room 853, 5333 Westbard
Avenue, Bethesda, MD 20892
Fogarty International Center, Scientific Review Administrator,
International Studies Branch, Building 31, Room B2C32, 9000
Rockville Pike, Bethesda, MD 20892
National Institute on Drug Abuse, Chief, Grants Management Branch,
Room 8A-54, Parklawn Building, 5600 Fishers Lane, Rockville, MD
20857
National Institute on Alcohol Abuse and Alcoholism, Chief, Grants
Operation Section, Willco Building, Suite 504, 6000 Executive Blvd.
MSC 7003, Bethesda, MD 20892-7003
National Institute of Mental Health, Grants Management Officer, ORM,
Room 7C-15, Parklawn Building, 5600 Fishers Lane, Rockville, MD
20857
Appendix III: Notification Procedures
National Cancer Institute, See Appendix II
National Heart, Lung, and Blood Institute, Privacy Act Coordinator,
Building 31, Room 5A10, 31 Center Drive, MSC 2490, Bethesda, MD
20892-2490
National Library of Medicine, See Appendix II
National Institute of Allergy and Infectious Diseases, See Appendix
II
National Institute of Diabetes and Digestive and Kidney Diseases,
Administrative Officer, Building 31, Room 9A46, 9000 Rockville Pike,
Bethesda, MD 20892
National Institute of Child Health and Human Development, See
Appendix II
National Institute of Aging, See Appendix II
National Institute of Dental Research, NIDR Privacy Act Coordinator,
Building 31, Room 2C-35, 9000 Rockville Pike, Bethesda, MD 20892
National Institute of Environmental Health Services, See Appendix II
National Institute of General Medical Sciences, See Appendix II
National Institute of Neurological Disorders and Stroke, See
Appendix II
National Institute on Deafness and Other Communication Disorders,
See Appendix II
National Eye Institute, See Appendix II
National Center for Nursing Research, See Appendix II
National Center for Research Resources, See Appendix II
Fogarty International Center, See Appendix II
National Institute on Drug Abuse, See Appendix II
National Institute on Alcohol Abuse and Alcoholism, See Appendix II
National Institute of Mental Health, Privacy Act Coordinator, Room
15-81, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857
Appendix IV: Records Access Procedures
Naitonal Cancer Institute, Privacy Act Coordinator, Building 31,
Room 10A30, 9000 Rockville Pike, Bethesda, MD 20892
National Heart, Lung, and Blood Institute, See Appendix III
National Library of Medicine, See Appendix II
National Institute of Allergy and Infectious Diseases, Privacy Act
Coordinator, Solar Bldg., Room 3C-23, Bethesda, MD 20892
National Institute of Diabetes and Digestive and Kidney Diseases,
See Appendix II
National Institute of Child Health and Human Development, See
Appendix II
National Institute on Aging, See Appendix II
National Institute of Dental Research, Grants Management Officer,
Westwood Building, Room 518, 5333 Westbard Avenue, Bethesda, MD
20892
National Institute of Environmental Health Sciences, See Appendix II
National Institute of General Medical Sciences, Privacy Act
Coordinator, Natcher Building, Room 3AS43, 9000 Rockville Pike,
Bethesda, MD 20892
National Institute of Neurological Disorders and Stroke, Chief,
Administrative Services Branch, Building 31, Room 8A49, 9000
Rockville Pike, Bethesda, MD 20892
National Institute on Deafness and Other Communication Disorders,
Chief, Administrative Management Branch, Building 31, Room 3C02,
9000 Rockville Pike, Bethesda, MD 20892
National Eye Institute, Administrative Officer, Building 31, Room
6A17, 9000 Rockville Pike, Bethesda, MD 20892
National Center for Research Resources, Privacy Act Coordinator,
Westwood Building, Room 10A15, 5333 Westbard Avenue, Bethesda, MD
20892
Fogarty International Center, See Appendix II
National Institute on Drug Abuse, See Appendix II
National Institute on Alcohol Abuse and Alcoholism, See Appendix II
National Institute of Mental Health, See Appendix II
National Institute of Nursing Research, See Appendix II.
09-25-0118
Contracts: Professional Services Contractors, HHS/NIH/NCI.
None.
Building 31, Room 3A44, DCT, 9000 Rockville Pike, Bethesda, MD 20892
Building 31, Room 11A33, OD, 9000 Rockville Pike, Bethesda, MD 20892
Executive Plaza North, Room 604, DEA, 9000 Rockville Pike, Bethesda, MD
20892
Building 31, Room 11A11, DCE, 9000 Rockville Pike, Bethesda, MD 20892
Building 31, Room 10A50, DCPC, 9000 Rockville Pike, Bethesda, MD 20892
Write to System Manager at the address below for the address of the
Federal Records Center where records may be stored.
Individuals under contract with the National Cancer Institute.
Professional Services Contracts.
42 U.S.C. 241(d), 281.
Used by staff for general administrative purposes to assure
compliance with contract program requirements.
1. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
2. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or individual
capacity where the Justice Department has agreed to represent such
employee, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice to
[[Page 4264]] enable that Department to present an effective defense,
provided such disclosure is compatible with the purpose for which the
records were collected.
Stored in file folders.
Retrieved by name.
1. Authorized users: Access is limited to authorized personnel
(system manager and staff).
2. Physical safeguards: Records are maintained in offices which are
locked when not in use.
3. Procedural safeguards: Access to files is strictly controlled by
system manager and staff.
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 2600-A-4, which allows records to be destroyed
after a maximum period of 6 years and 3 months after final payment.
Refer to the NIH Manual Chapter for specific disposition instructions.
Administrative Officer, DCT, Building 31, Room 3A44, 9000 Rockville
Pike, Bethesda, MD 20892
Administrative Officer, OD, National Institutes of Health, Building 31,
Room 11A33, 9000 Rockville Pike, Bethesda, MD 20892
Administrative Officer, DEA, Executive Plaza North, Room 604, 9000
Rockville Pike, Bethesda, MD 20892
Administrative Officer, DCE, Building 31, Room 11A11, 9000 Rockville
Pike, Bethesda, MD 20892
Administrative Officer, DCPC, Building 31, Room 10A50, 9000 Rockville
Pike, Bethesda, MD 20892
Write to the appropriate System Manager listed above to determine
if a record exists. The requester must also verify his or her identity
by providing either a notarization of the request or a written
certification that the requester is who he or she claims to be and
understands that the knowing and willful request for acquisition of a
record pertaining to an individual under false pretenses is a criminal
offense under the Act, subject to a five thousand dollar fine.
Same as notification procedures.
Requesters should also reasonably specify the record contents being
sought. Individuals may also request listings of accountable
disclosures that have been made of their records, if any.
Contact the official under notification procedures above, and
reasonably identify the record and specify the information to be
contested, and state the corrective action sought and the reasons for
the correction, with supporting justification. The right to contest
records is limited to information which is incomplete, irrelevant,
incorrect, or untimely (obsolete).
Individuals in the system.
None.
09-25-0126
Clinical Research: National Heart, Lung, and Blood Institute
Epidemiological and Biometric Studies, HHS/NIH/NHLBI.
None.
Records included in this system are located in hospitals,
universities, research centers, research foundations, and coordinating
centers under contract with the National Heart, Lung, and Blood
Institute, and in NHLBI facilities in Bethesda, Maryland. Write to the
system manager at the address below for a list of locations, including
the address of any Federal Records Center where records from this
system may be stored.
Participants in these studies include (1) individuals who have been
or who are presently being treated by the National Heart, Lung, and
Blood Institute, for diseases or conditions of the heart, lung, blood
vessels and blood; (2) individuals whose physical, genetic, social,
economic, environmental, behavioral or nutritional conditions or habits
are being studied in relation to the incidence of heart, lung, blood
vessel and blood diseases among human beings; and (3) normal volunteers
who have agreed to provide control data germane to these studies.
This system consists of a variety of clinical, medical, and
statistical information resulting from or contained in research
findings, medical histories, vital statistics, personal interviews,
questionnaires, or direct observation. The system also includes records
of current addresses of study participants, photographs, fingerprints,
and correspondence from or about participants in these studies.
Sec. 412, 413 of the Public Health Service Act (42 U.S.C. 287a,
287b).
(1) Summaries of data resulting from these studies are used by the
National Heart, Lung, and Blood Institute to monitor and evaluate the
incidence of the diseases or the conditions under investigation and the
relationship of various factors to the occurrence of these diseases.
(2) The summaries are also used for program planning and evaluation
purposes.
1. Disclosure may be made to HHS contractors, grantees and
collaborating researchers and their staff in order to accomplish the
research purpose for which the records are collected. The recipients
are required to protect such records from improper disclosure.
2. Referrals may be made of assignments of research investigators
and project monitors to specific research projects to the Smithsonian
Institution to contribute to the Smithsonian Science Information
Exchange, Inc.
3. In the event the Department deems it desirable or necessary, in
determining whether particular records are required to be disclosed
under the Freedom of Information Act, disclosures may be made to the
Department of Justice for the purpose of obtaining its advice.
4. Where the appropriate official of the Department, pursuant to
the Department's Freedom of Information Regulation determines that it
is in the public interest to disclose a record which is otherwise
exempt from mandatory disclosure, disclosure may be made from this
system of records.
5. The Department contemplates that it will contract with a private
firm for the purpose of collating, analyzing, aggregating or otherwise
refining records in this system. Relevant records will be disclosed to
such a contractor. The contractor shall be required to maintain Privacy
Act safeguards with respect to such records. [[Page 4265]]
6. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example in defending against a claim based upon an
individual's mental or physical condition and alleged to have arisen
because of activities of the Public Health Service in connection with
such individual, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice or other
appropriate Federal agency to enable that agency to present an
effective defense, provided that such disclosure is compatible with the
purpose for which the records were collected.
7. Disclosure may be made to organizations deemed qualified by the
Secretary to carry out quality assessments, medical audits or
utilization review.
8. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
9. A record may be disclosed for a research purpose, when the
Department: (A) Has determined that the use or disclosure does not
violate legal or policy limitations under which the record was
provided, collected, or obtained; (B) has determined that the research
purpose (1) cannot be reasonably accomplished unless the record is
provided in individually identifiable form, and (2) warrants the risk
to the privacy of the individual that additional exposure of the record
might bring; (C) has required the recipient to (1) establish reasonable
administrative, technical, and physical safeguards to prevent
unauthorized use or disclosure of the record, (2) remove or destroy the
information that identifies the individual at the earliest time at
which removal or destruction can be accomplished consistent with the
purpose of the research project, unless the recipient has presented
adequate justification of a research or health nature for retaining
such information, and (3) make no further use or disclosure of the
record except (a) in emergency circumstances affecting the health or
safety of any individual, (b) for use in another research project,
under these same conditions, and with written authorization of the
Department, (c) for disclosure to a properly identified person for the
purpose of an audit related to the research project, if information
that would enable research subjects to be identified is removed or
destroyed at the earliest opportunity consistent with the purpose of
the audit, or (d) when required by law; (D) has secured a written
statement attesting to the recipient's understanding of, and
willingness to abide by these provisions.
Data may be stored in file folders, magnetic tapes or discs,
punched cards, bound note books.
Name and/or participant identification number.
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location and for the particular records maintained
in each project. Each site implements personnel, physical and
procedural safeguards such as the following:
1. Authorized users: Employees who maintain records in this system
are instructed to grant regular access only to authorized researchers,
physicians and their assistants whose duties require the use of such
information.
2. Physical safeguards: Records are kept in locked file cabinets
and in some instances in locked offices or guarded buildings. Locations
are locked during non-working hours, and are attended at all times
during working hours.
3. Procedural safeguards: Access to the data is controlled by the
System Manager and the Project Officer. Data stored in computers is
accessed through the use of key words known only to principal
investigators or authorized personnel.
The particular safeguards implemented at each site are developed in
accordance with Chapter 45-13, ``Safeguarding Records Contained in
Systems of Records,'' of the HHS General Administration Manual,
supplementary Chapter PHS.hf: 45-13, and Part 6, ``ADP Systems
Security'', of the HHS Information Resources Management Manual and the
National Institute of Standards and Technology Federal Information
Processing Standards (FIPS Pub. 41 and FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
Senior Scientific Advisor, OD, Division of Epidemiology and Clinical
Applications, National Heart, Lung, and Blood Institute, Federal
Building, Room 220, 7550 Wisconsin Avenue, Bethesda, MD 20892.
To determine if a record exists, contact: NHLBI Privacy
Coordinator, Building 31, Room 5A-08, National Institutes of Health,
9000 Rockville Pike, Bethesda, MD 20892.
Requesters must provide the following information in writing:
1. Full name
2. Name and location of research study
3. Approximate dates of enrollment.
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
An individual who requests notification of or access to a medical/
dental record shall, at the time the request is made, designate in
writing a responsible representative who will be willing to review the
record and inform the subject individual of its contents at the
representative's discretion.
A parent or guardian who requests notification of, or access to, a
child's or incompetent person's medical record shall designate a family
physician or other health professional (other than a family member) to
whom the record, if any, will be sent. The parent or guardian must
verify relationship to the child or incompetent person as well as his
or her own identity.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Write to System Manager as indicated above. The contestor must
reasonably [[Page 4266]] specify in writing the record contents at
issue and state the corrective action sought and the reasons for the
correction. The right to contest with supporting justification. The
record is limited to information which is incomplete, irrelevant,
incorrect, or untimely (obsolete).
Information contained in these records is obtained directly from
individual participants and from medical and clinical research
observations.
None.
09-25-0128
Clinical Research: Neural Prosthesis & Biomedical Engineering
Studies, HHS/NIH/NINDS.
None.
Federal Building, Room 9C02, 7550 Wisconsin Ave., Bethesda, MD 20892
and: (1) At hospitals and medical centers under contract, and (2)
Federal Records Centers. A list of locations is available upon request
from the system manager.
Patients and normal volunteers, males and females, participating in
clinical studies to determine the feasibility of neural prostheses, and
in clinical studies related to the development of instrumentation for
diagnosis and treatment of neurological and sensory disorders conducted
under contract for the National Institute of Neurological Disorders and
Stroke (NINDS).
Clinical research data as related to studies which seek to
determine the feasibility of neural prostheses and to develop
instrumentation for diagnosis and treatment of neurological and sensory
disorders.
42 U.S.C. 421, 289a, 289c.
(1) Clinical research on the development of neural prosthesis
(artificial devices) to enhance function of individuals with various
disorders of the central nervous system.
(2) Research on the development of new instruments to improve
diagnosis and treatment of disorders of the nervous system.
1. Disclosure may be made to HHS contractors, grantees and
collaborating researchers and their staff in order to accomplish the
research purpose for which the records are collected. The recipients
are required to protect such records from improper disclosure.
2. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
3. In the event of litigation where the defendant is (a) The
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example in defending against a claim based upon an
individual's mental or physical condition and alleged to have arisen
because of activities of the Public Health Service in connection with
such individual, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice or other
appropriate Federal agency to enable that agency to present an
effective defense, provided that such disclosure is compatible with the
purpose for which the records were collected.
Records are stored in file folders.
Records are retrieved by name.
1. Authorized users: Employees who maintain records in this system
are instructed to grant access only to HHS scientists and their
authorized collaborators.
2. Physical safeguards: Records are kept in a locked room when not
in use.
3. Procedural safeguards: Personnel having access to this system
are informed of Privacy Act requirements.
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
Head, Neural Prosthesis Program, NINDS, Federal Building, Room 916,
7550 Wisconsin Ave., Bethesda, MD 20892
Write to:
Chief, Administrative Services Branch, NINDS, Building 31, Room 8A49,
9000 Rockville Pike, Bethesda, MD 20892
and ask if a file with your name exists in the Neural Prosthesis or
Biomedical Engineering Studies. The requester must also verify his or
her identity by providing either a notarization of the request or a
written certification that the requester is who he or she claims to be
and understands that the knowing and willful request for acquisition of
a record pertaining to an individual under false pretenses is a
criminal offense under the Act, subject to a five thousand dollar fine.
An individual who requests notification of or access to a medical
record shall, at the time the request is made, designate in writing, a
responsible representative, who may be a physician, who will be willing
to review the record and inform the subject individual of its contents
at the representative's discretion.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Write to system manager and reasonably identify the record and
specify the information to be contested, and state the corrective
action sought and the reasons for the correction.
Patients, patients' families, hospital records and clinical
investigators.
None. [[Page 4267]]
09-25-0129
Clinical Research: Clinical Research Studies Dealing with Hearing,
Speech, Language and Chemosensory Disorders, HHS/NIH/NIDCD.
None.
National Institute on Deafness and Other Communication Disorders
(NIDCD); 6120 Executive Boulevard, Rockville, MD 20852
and at hospitals, medical centers, universities and educational
settings under contract. Inactive records may be stored at a Federal
Records Center. A list of locations is available upon request from the
System Manager at the address below.
Patients and normal volunteers participating in clinical research
studies dealing with hearing, speech, language and chemosensory
disorders.
Medical findings, clinical research data, medical and educational
histories and research data on the hearing, speech, language, cognition
and chemosensory systems of subjects being tested.
42 U.S.C. 241, 289a, 289c.
Clinical research on the disorders of speech, language, and hearing
to discover factors leading to these disorders and to improve
prevention, diagnoses, and treatment.
1. Disclosure may be made to HHS contractors, grantees and
collaborating researchers and their staff in order to accomplish the
research purpose for which the records are collected. The recipients
are required to protect such records from improper disclosure.
2. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
3. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example in defending against a claim based upon an
individual's mental or physical condition and alleged to have arisen
because of activities of the Public Health Service in connection with
such individual, the Department may disclose such records as its deems
desirable or necessary to the Department of Justice or other
appropriate Federal agency to enable that agency to present an
effective defense, provided that such disclosure is compatible with the
purpose for which the records were collected.
Records are stored in file folders.
Name or identifier code.
1. Authorized users: Employees who maintain the system are
instructed to grant access only to the principal investigator and staff
assigned to a particular project, and to other authorized personnel
(project officer, contracting officer).
2. Physical safeguards: Records are locked in cabinets when not in
actual use and system location is locked during non-working hours.
3. Procedural safeguards: Personnel having access to system are
trained in Privacy Act requirements. Records are returned to locked
file cabinets at end of working day.
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-3610, item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
Director, Division of Human Communication, NIDCD, Executive Plaza
South, Room 400B, 6120 Executive Boulevard, Rockville, MD 20852
Write to:
Chief, Administrative Management Branch, NIDCD, Building 31, Room 3C21,
9000 Rockville Pike, Bethesda, MD 20892
and ask if a file exists with your name in studies of the Division of
Communication Sciences and Disorders. Please supply the following
information:
1. Approximate date and place of examination and/or treatment.
2. Name of the study, if known.
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
An individual who requests notification of or access to a medical
record shall, at the time the request is made, designate in writing, a
responsible representative, who may be a physician, who will be willing
to review the record and inform the subject individual of its contents
at the representative's discretion.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Write to system manager and reasonably identify the record, specify
the information to be contested, and state the corrective action sought
and the reasons for the correction. The right to contest records is
limited to information which is incomplete, irrelevant, incorrect, or
untimely (obsolete).
Information provided by patients, patients' families, hospital
records, school records, and clinical investigators.
None.
09-25-0140
International Activities: International Scientific Researchers in
Intramural Laboratories at the National Institutes of Health, HHS/NIH/
FIC. [[Page 4268]]
None.
Fogarty International Center, Building 16A, Room 101, 9000 Rockville
Pike, Bethesda, MD 20892
and
Division of Computer Research and Technology, Building 12A, Room 3061,
National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892
Ancillary records are located in the Office of the Associate
Director for Intramural Affairs, laboratories, administrative and
personnel offices where participants are assigned. Write to System
Manager at the address below for the address of the Federal Records
Center where records are stored.
Health scientists at all levels of their postdoctoral or equivalent
research careers who are invited to the National Institutes of Health
for further training or to conduct research in their biomedical
specialties under the auspices of FIC's administration of International
Activities. Most of these scientists are foreign, however, some may be
resident aliens or U.S. citizens.
Individuals in these categories include Visiting Associates,
Visiting Scientists, Foreign Special Experts who are employees and
Visiting Fellows, Guest Researchers, Exchange Scientists, International
Research Fellows, Fogarty Scholars, Special Volunteers, Adjunct
Scientists and Residents who are not employees.
History of fellowship, employment and/or stay at NIH; education,
immigration data and references. For payroll purposes, social security
numbers are requested of all applicants accepted into the program.
42 USC 2421 and section 307 of the Public Health Service Act.
To document the individual's presence at the NIH, to record
immigration history of the individual in order to verify continued
eligibility in existing programs, and to meet requirements in the Code
of Federal Regulations (8 CFR, ``Aliens and Nationality,'' and 22 CFR,
``Foreign Relations'').
1. Information is made available to authorized employees and agents
of the U.S. Government including, but not limited to, the General
Accounting Office, the Internal Revenue Service, and the FBI and
Immigration and Naturalization Service, Department of Justice, for
purposes of investigations, inspections and audits.
2. Disclosures may be made to a congressional office from the
record of an individual in response to an inquiry from the
congressional office made at the request of the individual.
3. The Department of Health and Human Services (HHS) may disclose
information from this system of records to the Department of Justice,
or to a court or other tribunal, when (a) HHS, or any component
thereof; or (b) any HHS employee in his or her official capacity; or
(c) any HHS employee in his or her individual capacity where the
Department of Justice (or HHS, where it is authorized to do so) has
agreed to represent the employee; or (d) the United States or any
agency thereof where HHS determines that the litigation is likely to
affect HHS or any of its components, is a party to litigation or has
any interest in such litigation, and HHS determines that the use of
such records by the Department of Justice, court or other tribunal is
relevant and necessary to the litigation and would help in the
effective representation of the governmental party, provided, however
that in each case, HHS determines that such disclosure is compatible
with the purpose for which the records were collected.
Records are stored in file folders, computer tapes, and computer
disks.
By name, country of citizenship, country of birth, gender,
fellowship case number, visa and immigration status, program category,
NIH Institute and lab, sponsor, degree attained, stipend or salary
level, dates of stay at NIH, termination date, work address and
telephone number, and home address.
A variety of safeguards is implemented for the various sets of
records included under this system according to the sensitivity of the
data they contain.
1. Authorized users: NIH administrative and personnel staff
screened by FIC staff to access information on a need-to-know basis.
Only FIC staff are authorized to add, change, or delete data. Access by
other employees is granted on a need-to-know basis as specifically
authorized by the system manager.
2. Physical safeguards: The records are maintained in file cabinets
in offices that are located during off-duty hours.
3. Procedural safeguards. Access to files is strictly controlled by
files staff. Records may be removed from files only at the request of
the system manager or other authorized employees. For computerized
records, access is controlled by the use of security codes known only
to authorized users; access codes are changed periodically. The
computer system maintains an audit record of all requests for access.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and Part 6, ``ADP Systems Security,'' of the HHS Information Resources
Management Manual and the National Institute of Standards and
Technology Federal Information Processing Standards (FIPS Pub. 41 and
FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 2300-320, which allows records to be destroyed
after a maximum period of 6 years after the close of a case. Refer to
the NIH Manual Chapter for specific disposition instructions.
Chief, International Services and Communications Branch, National
Institutes of Health, Fogarty International Center, Building 16A, Room
101, 16A Center Drive MSC 6710, Bethesda, MD 20892-6710
Write to the System Manager to determine if a record exists. The
requester must also verify his or her identity by providing either a
notarization of the request or a written certification that the
requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an [[Page 4269]] individual under false pretenses is a criminal offense
under the Act, subject to a five thousand dollar fine.
Same as notification procedure. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Contact the official listed under notification procedure above, and
reasonably identify the record, and specify the information to be
contested, and state the corrective action sought and the reasons for
the correction. The right to contest records is limited to information
which is incomplete, irrelevant, incorrect, or untimely (obsolete).
Subject individuals and other federal agencies.
None.
09-25-0142
Clinical Research: Records of Subjects in Intramural Research,
Epidemiology, Demography and Biometry Studies on Aging, HHS/NIH/NIA.
None.
Records included in this system will be located in hospitals and
clinics, research centers and research foundations, and in facilities
of the National Institute on Aging (NIA) in Bethesda, MD. They may be
stored at Federal Records Centers. A list of locations is available
upon request from the System Manager.
Participants in these studies will include: (1) Individuals whose
physical, genetic, social, psychological, cultural, economic,
environmental, behavioral, pharmacological, or nutritional conditions
or habits are studied in relationship to the normal aging process and/
or diseases and other normal or abnormal physical or psychological
conditions of the aged, and (2) normal volunteers who are participants
in such studies.
This system will consist of a variety of health, demographic, and
statistical information resulting from or contained in research
findings, medical histories, vital statistics, personal interviews,
questionnaires, or direct observations. The system will also include
records of current addresses of study participants, and correspondence
from or about participants in the studies. When supplied on a voluntary
basis, Social Security numbers will also be included.
Authority is provided by Section 301, Research Contracting, and
463-4, Health Research Extension Act of 1985, Pub. L. 99-158.
The National Institute on Aging will use the data collected; (1) in
research projects on (a) the health status of individuals and changes
in health status over time, (b) the incidence and prevalence of certain
diseases and problems of the aged in certain populations, and (c) the
changes that take place as individuals age; (2) and for program
planning and evaluation.
1. Records may be disclosed to HHS contractors, collaborating
researchers and their staffs in order to accomplish the basic research
purpose of this system. The recipients will be required to maintain
Privacy Act safeguards with respect to such records.
2. Data may be disclosed to organizations deemed qualified by the
Secretary to carry out quality assessment, medical audits or
utilization review.
3. A record may be disclosed for a research purpose, when the
Department: (A) Has determined that the use or disclosure does not
violate legal or policy limitations under which the record was
provided, collected, or obtained; (B) has determined that the research
purpose (1) cannot be reasonably accomplished unless the record is
provided in individually identifiable form, and (2) warrants the risk
to the privacy of the individual that additional exposure of the record
might bring; (C) has required the recipient to (1) establish reasonable
administrative, technical, and physical safeguards to prevent
unauthorized use or disclosure of the record, (2) remove or destroy the
information that identifies the individual at the earliest time at
which removal or destruction can be accomplished consistent with the
purpose of the research project, unless the recipient has presented
adequate justification of a research or health nature for retaining
such information, and (3) make no further use or disclosure of the
record except (a) in emergency circumstances affecting the health or
safety of any individual, (b) for use in another research project,
under these same conditions, and with written authorization of the
Department, (c) for disclosure to a properly identified person for the
purpose of an audit related to the research project, if information
that would enable research subjects to be identified is removed or
destroyed at the earliest opportunity consistent with the purpose of
the audit, or (d) when required by law; (D) has secured a written
statement attesting to the recipient's understanding of, and
willingness to abide by these provisions.
4. In the event the Department deems it desirable or necessary, in
determining whether particular records are required to be disclosed
under the Freedom of Information Act, disclosure may be made to the
Department of Justice for the purpose of obtaining its advice.
5. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice to enable that
Department to present an effective defense, provided that such
disclosure is compatible with the purpose for which the records were
collected.
6. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of the individual.
Data may be stored in file folders, boxes, network drives, magnetic
tapes or discs, punched cards, or bound notebooks. Stored data may
include textual, photographic, X-ray, or other material.
Information will be retrieved by personal identifiers such as name,
code number and/or Social Security number, when this is supplied on a
voluntary basis. [[Page 4270]]
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location and for the particular records maintained
in each project. Each site implements personnel, physical and
procedural safeguards such as the following:
1. Authorized users: Access will be limited to principal
investigators, collaborating researchers and necessary support staff.
2. Physical safeguards: Hard copy data will be maintained in locked
file cabinets. Information stored in computer systems will be
accessible only through proper sequencing of signal commands and access
codes specifically assigned to the Project Officer or contractor.
3. Procedural safeguards: Access to the information will be
controlled directly by the Project Officer or his or her representative
at remote locations, and by the system manager at NIA locations.
Contractors and collaborating researchers will be notified that they
are subject to the provisions of the Privacy Act, and will be required
to make formal agreements to comply with these provisions.
The particular safeguards implemented in each project are developed
in accordance with Chapter 45-13 and supplementing Chapter PHS hf: 45-
13 of the HHS General Administration Manual and Part 6, ADP Systems
Security, of the HHS Information Resources Management Manual, and the
National Institute of Standards and Technology Federal Information
Processing Standards (FIPS Pub. 41 and FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
Associate Director, Epidemiology, Demography and Biometry Program,
National Institute on Aging, Gateway Building, Suite 3C309, 7201
Wisconsin Avenue, Bethesda, MD 20892
To determine if a record exists, write to the System Manager at the
above address and provide the following information in writing:
1. Full name at time of participation in the study.
2. Date of birth.
3. Home address at the time of study.
4. The facility where the examination was given or where
information was collected.
5. Approximate date or dates of participation.
6. Name of study, if known.
7. Current name, address and telephone number.
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
An individual who requests notification of or access to a medical
or dental record shall, at the time the request is made, designate in
writing a responsible representative who will be willing to review the
record and inform the subject individual of its contents at the
representative's discretion.
Contact the system manager at the above address and provide the
same information as outlined under the notification procedures.
Requesters should also reasonably specify the record contents being
sought. Individuals may also request listings of accountable
disclosures that have been made of their records, if any.
Contact the System Manager at the above address. The contestor must
reasonably identify the record, specify in writing the information
being contested, and state the corrective action sought and the reasons
for the correction. The right to contest records is limited to
information which is incomplete, irrelevant, incorrect or untimely
(obsolete).
Information will be obtained directly from individual participants
and from medical and clinical research observations, or indirectly from
existing source documents such as disease registries.
None.
09-25-0148
Contracted and Contract-Related Research: Records of Subjects in
Clinical, Epidemiological and Biomedical Studies of the National
Institute of Neurological Disorders and Stroke and the National
Institute on Deafness and Other Communication Disorders, HHS/NIH/NINDS
and HHS/NIH/NIDCD.
None.
At National Institutes of Health facilities in Bethesda, Maryland,
and at hospitals, medical schools, universities, research institutions,
commercial organizations, state agencies, and collaborating Federal
agencies. Inactive records may be retired to Federal Records Centers. A
list of locations is available upon request from the respective System
Managers of the subsystems included in this notice.
Patients with neurological diseases, communicative disorders,
stroke, hearing loss, chemosensory deficits, and related diseases;
normal, healthy volunteers who serve as controls for comparison with
patients, relatives of patients; and other individuals whose
characteristics or conditions are suited for possible connections with
the occurrence of the diseases and disorders under investigations.
Subject individuals include both adults and children.
This system consists of a variety of clinical, biomedical, and
epidemiological information resulting from or contained in direct
observations, medical records and other histories, vital statistics
reports, records on biological specimens (e.g., blood, urine, etc.),
personal interviews, questionnaires, progress reports, correspondence,
or research findings.
Sections 241, Research and Investigation, and 289a, Establishment
of Institutes, of the Public Health Service Act (42 U.S.C. 301, 431).
This system will be used to support (1) contracted and contract-
related epidemiological, clinical and biometric investigations into the
causes, nature, outcome, therapy, prevention and cost of neurological
and communicative [[Page 4271]] disorders, hearing loss, chemosensory
deficits, and stroke; (2) review and evaluation of the progress of
these research projects, and identification and planning for
improvements or for additional research.
1. Disclosure may be made to HHS contractors, grantees and
collaborating researchers and their staff in order to accomplish the
research purpose for which the records are collected. The recipients
are required to protect such records from improper disclosure.
2. Disclosure may be made to organizations deemed qualified by the
Secretary to carry out quality assessments, medical audits or
utilization review.
3. A record may be disclosed for a research purpose, when the
Department: (A) Has determined that the use or disclosure does not
violate legal or policy limitations under which the record was
provided, collected, or obtained; (B) has determined that the research
purpose (1) cannot be reasonably accomplished unless the record is
provided in individually identifiable form, and (2) warrants the risk
to the privacy of the individual that additional exposure of the record
might bring; (C) has required the recipient to (1) establish reasonable
administrative, technical, and physical safeguards to prevent
unauthorized use or disclosure of the record, (2) remove or destroy the
information that identifies the individual at the earliest time at
which removal or destruction can be accomplished consistent with the
purpose of the research project, unless the recipient has presented
adequate justification of a research or health nature for retaining
such information, and (3) make no further use or disclosure of the
record except (a) in emergency circumstances affecting the health or
safety of any individual, (b) for use in another research project,
under these same conditions, and with written authorization of the
Department, (c) for disclosure to a properly identified person for the
purpose of an audit related to the research project, if information
that would enable research subjects to be identified is removed or
destroyed at the earliest opportunity consistent with the purpose of
the audit, or (d) when required by law; (D) has secured a written
statement attesting to the recipient's understanding of, and
willingness to abide by these provisions.
4. The Department contemplates that it may contract with a private
firm for the purpose of collating, analyzing, aggregating or otherwise
refining records in this system. Relevant records will be disclosed to
such a contractor. The contractor will be required to maintain Privacy
Act safeguards with respect to such records.
5. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example, in defending against a claim based upon an
individual's mental or physical condition and alleged to have arisen
because of activities of the Public Health Service in connection with
such individual, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice to enable that
Department to present an effective defense, provided that such
disclosure is compatible with the purpose for which the records were
collected.
6. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
Data may be stored in file folders, computer-accessible forms (e.g.
tapes or discs), punched cards, bound notebooks, microfilm, charts,
graphs and X-rays.
Information is retrieved by name and/or patient identification
number.
1 Authorized users: Access to or disclosure of information is
limited to collaborating researchers, contractors and employees, and
other authorized biomedical researchers who are involved in the
conduct, support or review and evaluation of the research activities
supported by this system.
2. Physical safeguards: Data are kept in secured areas (e.g. rooms
which are locked when not in regular use, buildings with controlled
access). Data stored in computer-accessible form is accessed through
the use of key words known only to principal investigators or
authorized personnel; all other information is stored in locked files.
3. Procedural safeguards: Contractors and collaborating or other
researchers are required to comply with the provisions of the Privacy
Act and with HHS Privacy Act regulations.
These and other appropriate safeguards are implemented in each
project in accordance with Chapter 45-13, ``Safeguarding Records
Contained in Systems of Records,'' of the HHS General Administration
Manual, supplementary Chapter PHS.hf: 45-13, and Part 6, ``ADP Systems
Security'', of the HHS Information Resources Management Manual and the
National Institute of Standards and Technology Federal Information
Processing Standards (FIPS Pub. 41 and FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
NINDS and NIDCD research activities are divided, functionally and
administratively. In effect, there are six subsystems within this
single umbrella system. NINDS has five programs and NIDCD one. System
Managers have been designated for each subsystem as follows:
Director, Division of Human Communication, NIDCD, NIH, Executive Plaza
South, Room 400B, 620 Executive Boulevard, Rockville, MD 20852
and
Director, Division of Fundamental Neurosciences, NINDS, NIH, Federal
Building, Room 916, 7550 Wisconsin Avenue, Bethesda, MD 20892
and
Deputy Director, Division of Convulsive, Developmental and
Neuromuscular, Disorders, NINDS, NIH, Federal Building, Room 816, 7550
Wisconsin Avenue, Bethesda, MD 20892
and
Director, Division of Demyelinating Atrophic, and Dementing Disorders,
NINDS, NIH, Federal Building, Room 810, 7550 Wisconsin Avenue,
Bethesda, MD 20892
and
[[Page 4272]] Director, Division of Stroke and Trauma, NINDS, NIH,
Federal Building, Room 8A08, 7550 Wisconsin Avenue, Bethesda, MD 20892
and
Assistant Director, Clinical Neurosciences Program, DIR, NIH, Building
10, Room 5N226, 9000 Rockville Pike, Bethesda, MD 20892
To determine if a record exists, write to:
NINDS Privacy Act Coordinator, Federal Building, Room 816, 7550
Wisconsin Avenue, Bethesda, MD 20892
or
NIDCD Privacy Act Coordinator, Building 31, Room 3C02, 9000 Rockville
Pike, Bethesda, MD 20892
and provide the following information:
1. System name,
2. Complete name and home address at the time of the study,
3. Birth date,
4. Facility conducting the study,
5. Disease type (if known),
6. Approximate dates of enrollment in the research study.
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
Individuals seeking notification of or access to medical records
should designate a representative (including address) who may be a
physician, other health professional, or other responsible individual,
who would be willing to review the record and inform the subject
individual of its contents, at the representative's discretion.
A parent or guardian who requests notification of, or access to, a
child's or incompetent person's medical record shall designate a family
physician or other health professional (other than a family member) of
whom the record, if any, will be sent. The parent or guardian must
verify relationship to the child or incompetent person as well as his
or her own identity.
Same as notifications procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Write to the system manager and reasonably identify the record,
specify the information being contested and state the corrective action
sought and the reasons for the correction. The right to contest records
is limited to information which is incomplete, irrelevant, incorrect,
or untimely (obsolete).
Information in these records is obtained directly from individual
participants, and from physicians, research investigators and other
collaborating persons, and from medical records and clinical research
observations at hospitals, HHS agencies, universities, medical schools,
research institutions, commercial institutions, state agencies, and
collaborating Federal agencies.
None.
09-25-0152
Biomedical Research: Records of Subjects in National Institute of
Dental Research Contracted Epidemiological and Biometric Studies, HHS/
NIH/NIDR.
None.
Records included in this system are collected by contractors and
are located in hospitals and clinics; research centers; educational
institutions; commercial; local, State and Federal government agencies;
and in National Institute of Dental Research (NIDR) facilities.
Inactive records may be stored at Federal Records Centers. A list of
locations and contracts is available upon request from the System
Manager.
Voluntary participants in epidemiological and biometric studies
sponsored by NIDR, including adults and minors, both males and females,
with known or suspected diseases or disorders of the teeth and
supporting structures, as well as normal or nonsuspect individuals in
control or study groups for purposes of comparison.
This system consists of medical and dental records and information
resulting from personal interviews, questionnaires, or direct
observation. The system may also include current addresses of study
participants, radiographs, records on biological specimens (e.g.,
teeth, plaque, etc.), study models, computerized epidemiological data
and correspondence.
Sections 301, 401, 405 and 453 of the Public Health Service Act (42
U.S.C. 241, 281, 284, 285h). These sections establish the National
Institute of Dental Research and authorize the conduct and support of
dental and oral research and related activities.
This system is used to: (1) Support research on diseases and
disorders of the oral cavity (teeth and their supporting structures);
their causes and treatment; the incidence and prevalence of these
diseases and disorders; and familial, demographic and behavioral
factors related to their causes and treatment; (2) provide data for
program review, evaluation, planning, and administrative
accountability.
1. Disclosure may be made to HHS contractors, grantees and
collaborating researchers and their staff for the purpose of analyzing
data and preparing scientific reports and articles in order to
accomplish the research purpose for which the records are collected.
The recipients are required to maintain Privacy Act safeguards with
regards to such records.
2. Disclosure may be made to organizations deemed qualified by the
Secretary to carry out quality assessment, medical audits or
utilization review.
3. A record may be disclosed for a research purpose, when the
Department: (A) Has determined that the use or disclosure does not
violate legal or policy limitations under which the record was
provided, collected, or obtained; (B) has determined that the research
purpose, (1) cannot be reasonably accomplished unless the record is
provided in individually identifiable form, and (2) warrants the risk
to the privacy of the individual that additional exposure of the record
might bring; (C) has required the recipient to, (1) establish
reasonable administrative, technical, and physical safeguards to
prevent unauthorized use or disclosure of the record, (2) remove or
destroy the information that identifies the individual at the earliest
time at which removal or destruction can be accomplished consistent
with the [[Page 4273]] purpose of the research project, unless the
recipient has presented adequate justification of a research or health
nature for retaining such information, and (3) make no further use or
disclosure of the record except (a) in emergency circumstances
affecting the health or safety of any individual, (b) for use in
another research project, under these same conditions, and with written
authorization of the Department, (c) for disclosure to a properly
identified person for the purpose of an audit related to the research
project, if information that would enable research subjects to be
identified is removed or destroyed at the earliest opportunity
consistent with the audit, or (d) when required by law; (D) has secured
a written statement attesting to the recipient's understanding of, and
willingness to abide by these provisions.
4. The Department contemplates that it will contract with a private
firm for the purpose of collating, analyzing, aggregating or otherwise
refining records in this system. Relevant records will be disclosed to
such a contractor. The contractor will be required to maintain Privacy
Act safeguards with respect to records.
5. Disclosure may be made to a congressional office from the record
to an individual in response to an inquiry from the congressional
office made at the request of the individual.
6. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee, for example, in defending
against a claim based upon an individual's mental or physical condition
and alleged to have arisen because of activities of the Public Health
Service in connection with such individual, the Department may disclose
such records as it deems desirable or necessary to the Department of
Justice to enable that Department to present an effective defense,
provided that such disclosure is compatible with the purpose for which
the records were collected.
Data may be stored in file folders, magnetic tapes or disks,
punched cards, or bound notebooks.
Information is retrieved by name and/or a participant
identification number.
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location and for the particular records maintained
in each project. Each site implements personnel, physical and
procedural safeguards such as the following:
1. Authorized users: Employees who maintain records in this system
are instructed to grant regular access only to contractor personnel;
consultants to the contractor; the NIDR project officer; and NIDR
employees whose duties require the use of such information. Access to
the data controlled by the Project Director, the NIDR Project Officer,
and/or the System Manager.
2. Physical safeguards: Records are stored in locked files or
secured areas. Computer terminals are in secured areas.
3. Procedural safeguards: Names and other identifying particulars
are deleted when data from original records is encoded for analysis.
Encoded data is indexed by code numbers. Tables linking these code
numbers with actual identifiers are maintained separately. Code numbers
and identifiers are linked only if there is a specific need. Data
stored in computers is accessed through the use of keywords known only
to the principal investigators or authorized personnel. These keywords
are changed frequently.
The particular safeguards implemented in each project will be
developed in accordance with Chapter 45-13, ``Safeguarding Records
Contained in Systems of Records,'' of the HHS General Administration
Manual, supplementary Chapter PHS.hf: 45-13, and Part 6, ``ADP Systems
Security'', of the HHS Information Resources Management Manual and the
National Institute of Standards and Technology Federal Information
Processing Standards (FIPS Pub. 41 and FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
Chief, Contract Management Section, Extramural Program, National
Institute of Dental Research, Natcher Building, Room 4AN-44B, 45 Center
Drive MSC 6402, Bethesda, MD 20892-6402
Write to:
Privacy Act Coordinator, National Institute of Dental Research, 31
Center Drive MSC 2290, Building 31, Room 2C-35, Bethesda, MD 20892-2290
and provide the following information in writing:
1. Full name at time of participation in the study.
2. Name and description of the study.
3. Location and approximate dates of participation.
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
An individual who requests notification of, or access to, a medical
or dental record shall, at the time the request is made, designate in
writing a responsible representative who will be willing to review the
record and inform the subject individual of its contents at the
representative's discretion.
A parent or guardian who requests notification of, or access to,
the medical record of a child or incompetent person shall designate a
family physician or other health professional (other than a family
member) to whom the records, if any, will be sent. The parent or
guardian must verify relationship to the child or incompetent person as
well as his or her own identity.
Same as notification. Requesters should also reasonably specify the
record contents being sought. Individuals may also request listings of
accountable disclosures that have been made of their records, if any.
Contact the System Manager at the address above. The contestor must
reasonably identify the record, specify in writing the information
being contested, and state the corrective action sought, and the
reason(s) for the corrective action, with supporting justification. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete). [[Page 4274]]
Information contained in these records is obtained directly from
individual participants and from medical/dental and clinical research
observations.
None.
09-25-0153
Biomedical Research: Records of Subjects in Biomedical and
Behavioral Studies of Child Health and Human Development, HSS/NIH/
NICHD.
None.
Records included in this system in this system are located in
hospitals and clinics, research centers, educational institutions,
commercial organizations, local and State agencies, and other Executive
Branch agencies of the Federal Government under contract to the
National Institute of Child Health and Human Development (NICHD), and
in NICHD facilities in Bethesda, Maryland. Inactive records may be
stored at Federal Records Centers. A list of specific locations and
contractors is available upon request from the System Manager, whose
address is listed below.
Participants in these studies include adults and children (a) who
are presently or have been treated by the NICHD, (b) whose physical,
genetic, social, economic, environmental, behavioral or nutritional
conditions or habits are being studied by the NICHD, or (c) normal
volunteers who have agreed to provide control data for purposes of
comparison.
This system consists of a variety of clinical, medical, and
statistical information collected in biomedical and behavioral research
studies, such as medical histories, vital statistics, personal
interviews, questionnaires, current addresses of study participants,
radiographs, records on biological specimens, study models, and
correspondence from or about participants in these studies.
Section 301, Research and Investigation, and section 441, National
Institute of Child Health and Human Development, of the Public Health
Service Act as amended (42 U.S.C. sections 241, 298d).
This system is used: (1) For program review, evaluation, planning,
and administrative management for research on child health and human
development; (2) to monitor the incidence, prevalence or development of
the disease, condition, behavior, or health status under investigation;
(3) to determine the relation of various factors (e.g., social,
economic, environmental, physical, and medical) to the occurrence of
the disease, condition, development, behavior, or health status under
investigation; (4) to identify abnormal disease, condition, or health
status and inform the Centers for Disease Control (CDC) or the Food and
Drug Administration (FDA) of the existence of such conditions. CDC uses
this information in fulfilling its congressionally mandated
responsibility for the monitoring of disease and prevention of
epidemics. FDA use this information in carrying out its congressional
mandate for controlling certain potentially harmful products.
1. Disclosure may be made to HHS contractors, grantees and
collaborating researchers and their staff for the purposes of analyzing
data and preparing scientific reports and articles in order to
accomplish the research purpose for which the records are collected.
The recipients are required to comply with the requirements of the
Privacy Act with respect to such records.
2. Disclosure may be made to organizations deemed qualified by the
Secretary to carry out quality assessment, medical audits or
utilization review.
3. The Department contemplates that it may contract with a private
firm for the purpose of collating, analyzing, aggregating or otherwise
refining records in this system. Relevant records will be disclosed to
such a contractor. The contractor will be required to comply with the
requirements of the Privacy Act with respect to such records.
4. Certain diseases and conditions, including infectious diseases,
may be reported to appropriate representatives of State or Federal
Government as required by State or Federal law.
5. A record may be disclosed for a research purpose, when the
Department: (A) Has determined that the use or disclosure does not
violate legal or policy limitations under which the record was
provided, collected, or obtained; (B) has determined that the research
purpose (1) cannot be reasonably accomplished unless the record is
provided in individually identifiable form, and (2) warrants the risk
to the privacy of the individual that additional exposure of the record
might bring; (C) has required the recipient to (1) establish reasonable
administrative, technical, and physical safeguards to prevent
unauthorized use or disclosure of the record, (2) remove or destroy the
information that identifies the individual at the earliest time at
which removal or destruction can be accomplished consistent with the
purpose of the research project, unless the recipient has presented
adequate justification of a research or health nature for retaining
such information, and (3) make no further use or disclosure of the
record except (a) in emergency circumstances affecting the health or
safety of any individual, (b) for use in another research project,
under these same conditions, and with written authorization of the
Department, (c) for disclosure to a properly identified person for the
purpose of an audit related to the research project, if information
that would enable research subjects to be identified is removed or
destroyed at the earliest opportunity consistent with the purpose of
the audit, or (d) when required by law; (D) has secured a written
statement attesting to the recipient's understanding of, and
willingness to abide by these provisions.
6. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
7. In the event of litigation where the defendant is: (a) The
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example in defending against a claim based upon an
individual's mental or physical condition and alleged to have arisen
because of activities of the Public Health Service in connection with
such individual, the Department may disclose such records as it deems
desirable or necessary to the Department of Justice to enable that
Department to present an effective defense, provided that such
disclosure is compatible with [[Page 4275]] the purpose for which the
records were collected.
Data may be stored in file folders, microfilm, magnetic tapes or
disks, punched cards, or bound notebooks.
Information is retrieved by name and/or a participant
identification number.
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location and for the particular records maintained
in each project. Each site implements personnel, physical and
procedural safeguards such as the following:
1. Authorized users: Employees who maintain records in this system
are instructed to grant regular access only to contractor personnel;
consultants to the contractor; the NICHD project officer; and NICHD
employees whose duties require the use of such information. One time
and special access to the data is controlled by the System Manager, the
NICHD Project Officer, and the Contract and/or Project Director.
2. Physical safeguards: Records are stored in locked files or
secured areas. Computer terminals are in secured areas.
3. Procedural safeguards: Names and other identifying particulars
are deleted when data from original records is encoded for analysis.
Encoded data is indexed by code numbers. Tables linking these code
numbers with actual identifiers are maintained separately. Code numbers
and identifiers are linked only if there is a specific need, such as
alerting the volunteer subjects to any findings in the study that night
affect their health. Data stored in computers is accessed through the
use of passwords/keywords known only to the principal investigators or
authorized personnel. These passwords/keywords are changed frequently.
The particular safeguards implemented in each project will be
developed in accordance with Chapter 45-13, ``Safeguarding Records
Contained in Systems of Records,'' of the HHS General Administration
Manual, supplementary Chapter PHS hf: 45-13; Part 6, ``ADP Systems
Security,'' of the HHS ADP Systems Manual, and the National Institute
of Standards and Technology Federal Information Processing Standards
(FIPS Pub. 41 and FIPS Pub. 31).
Records are trained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
Chief, Contracts Management Branch, NICHD, Executive Building, Room
7A07, 6100 Executive Blvd., North Bethesda, MD 20892-7510
To determine if a record exists, write to:
NICHD Privacy Act Coordinator, Executive Building, Room 4A01B, 6100
Executive Blvd., North Bethesda, MD 20892-7510
and provide the following information in writing:
1. Full name and address at time of participation in the study.
2. Name or description of the study.
3. Location and approximate dates of participation.
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
An individual who requests notification of, or access to, a medical
record shall, at the time the request is made, designate in writing a
responsible representative who will be willing to review the record and
inform the subject individual of its contents at the representative's
discretion.
A parent or guardian who requests notification of, or access to,
the medical record of a child or incompetent person shall designate a
family physician or other health professional (other than a family
member) to whom the record, if any, will be sent. The parent or
guardian must verify his or her relationship to the child or
incompetent person as well as his or her own identity.
Same as notification procedure above. Requesters should also
reasonably specify the record contents being sought. Individuals may
also request listings of accountable disclosures that have been made of
their records, if any.
Write to the official specified under notification procedures
above, and reasonably identify the record and specify the information
being contested, the corrective action sought, and your reasons for
requesting the correction, along with supporting information to show
how the record is inaccurate, incomplete, untimely or irrelevant. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
Information contained in these records is obtained directly from
individual participants, medical and clinical research observations,
and other federal agencies.
None.
09-25-0154
Biomedical Research Records of Subjects: (1) Cancer Studies of the
Division of Cancer Prevention and Control, HHS/NIH/NCI; and (2) Women's
Health Initiative (WHI) Studies, HHS/NIH/OD.
None.
National Institutes of Health, Executive Plaza North, Room 343K, 6130
Executive Blvd. MSC 7350, Bethesda, MD 20892-7350
and
National Institutes of Health, Building 12, 9000 Rockville Pike,
Bethesda, MD 20892
and
National Institutes of Health, Building 1 Room 260, 9000 Rockville
Pike, Bethesda, MD 20892
and at hospitals, medical schools, universities, research institutions,
commercial organizations, collaborating State and Federal Government
agencies, and Federal Records Centers. Write to system manager at the
address below for the address of current locations.
NCI: Adults and children in the following categories: Patients with
cancer; persons for whom cancer risk can potentially be lowered; and
persons without signs or symptoms who may be identified through
screening and detection methods as having cancer or [[Page 4276]] being
at increased risk of developing cancer. For certain types of
epidemiologic studies, e.g., case-control studies, NCI may also
collect, for purposes of comparison, records on other persons. These
comparison groups could include normal individuals (e.g., family
members or neighborhood controls), or other patient groups (e.g.,
hospital controls) who do not have cancer or are not at a particularly
high risk of developing cancer. Health care and educators who provide
services and training for all such persons above. WHI: Women for whom
risk of cancer and/or other chronic disease may potentially be lowered.
Women without signs or symptoms of chronic disease who may be
identified through screening and detection methods as being at risk for
serious chronic ailments. WHI may also collect, for purposes of
comparison, longitudinal records on other women for whom no added
disease risk has been identified.
Information identifying participants (such as name, address, Social
Security Number), medical records, progress reports, correspondence,
epidemiologic data, and records on biological specimens (e.g., blood,
tumors, urine, etc).
NCI: Sections 301, Research and Investigation, 405 Appointment and
Authority of the Directors of the National Research Institutes, and
Title IV, Part C, Subpart 1--National Cancer Institute, of the Public
Health Service (PHS) Act (42 U.S.C. 241, 284 and 285-285a-5). WHI: 42
U.S.C. 241 and section 402, Appointment and Authority of Director of
NIH, of the PHS (42 U.S.C. 282).
Records in this system will be used, (1) to evaluate cancer and
other chronic disease control programs, such as prevention, screening,
detection, diagnosis, treatment, rehabilitation, and continuing care;
(2) to identify characteristics of persons who may be particularly
susceptible to environmental or occupational factors for substances
which cause or prevent cancer and/or other chronic diseases; (3) to
determine risk factors or substances which cause or prevent cancer and/
or other chronic diseases, and the ways in which they do so; (4) to
evaluate statistical and epidemiological methodologies for risk factor
assessment, clinical trials, cancer control studies, and the study of
the natural history of cancers and/or other chronic diseases; (5) to
plan for, administer, and review research activities as described in
the above purposes; (6) information from this system may be reported to
the Food and Drug Administration (FDA) as a condition for approval of
clinical investigations of new drugs, or to report adverse effects of
drugs so that FDA can make informed decisions on authorizing use of
such drugs.
1. Disclosure may be made to HHS contractors, grantees and
collaborating researchers and their staff in order to accomplish the
research purposes for which the records are collected. The recipients
are required to comply with the requirements of the Privacy Act with
respect to such records.
2. Disclosure may be made to organizations deemed qualified by the
Secretary to carry out quality assessments, medical audits or
utilization review.
3. The Department contemplates that it may contract with a private
firm for the purposes of collating, analyzing, aggregating or otherwise
refining records in this system. Relevant records will be disclosed to
such a contractor. The contractor will be required to comply with the
requirements of the Privacy Act with respect to such records.
4. A record be disclosed for a research purpose, when the
Department: (a) Has determined that the use or disclosure does not
violate legal or policy limitations under which the record was
provided, collected, or obtained; (B) has determined that the research
purpose (1) cannot be reasonably accomplished unless the record is
provided in individually identifiable form, and (2) warrants the risk
to the privacy of the individual that additional exposure of the record
might bring; (C) has required the recipient to (1) establish reasonable
administrative, technical, and physical safeguards to prevent
unauthorized use or disclosure of the record, (2) remove or destroy the
information that identifies the individual at the earliest time at
which removal or destruction can be accomplished consistent with the
purpose of the research project, unless the recipient has presented
adequate justification of a research or health nature for retaining
such information, and (3) make no further use or disclosure of the
record except (a) in emergency circumstances affecting the health or
safety of any individual, (b) for use in another research project,
under these same conditions, and with written authorization of the
Department, (c) for disclosure to a properly identified person for the
purpose of an audit related to the research project, if information
that would enable research subjects to be identified is removed or
destroyed at the earliest opportunity consistent with the purpose of
the audit, or (d) when required by law; (D) has secured a written
statement attesting to the recipient's understanding of, and
willingness to abide by these provisions.
5. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
6. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example, in defending a claim against the Public Health
Service based upon an individual's mental or physical condition and
alleged to have arisen because of activities of the Public Health
Service in connection with such individual, the Department may disclose
such records as it deems desirable or necessary to the Department of
Justice to enable that Department to present an effective defense,
provided that such disclosure is compatible with the purpose for which
the records were collected.
File folders, microfilm, charts, graphs, computer tapes, disks, and
punch cards.
By name, Social Security Number when supplied voluntarily or
contained in existing records used in projects under this system, or
other identifying number.
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location and for the particular records maintained
in each project. Each site implements personnel, physical and
procedural safeguards such as the following:
1. Authorized users. NCI and WHI employees who maintain records in
this [[Page 4277]] system are instructed to grant regular access only
to physicians, scientists, and support staff of the National Cancer
Institute and Women's Health Initiative, respectively, or their
contractors, grantees or collaborators who need such information in
order to contribute to the research or administrative purposes of the
system. The system managers specifically authorize one-time and special
access by others on a need-to-know basis consistent with the purposes
and routine uses of the system.
2. Physical safeguards. Records are kept in limited access areas.
Offices and records storage locations are locked during off-duty hours.
Input data for computer files is coded to avoid individual
identification. Where possible, information on individual identities is
kept separate from data used for analysis.
3. Procedural safeguards. Access to manual files is granted only to
authorized personnel, as described above. Access to computer files is
controlled through security codes known only to authorized users. Names
and other details necessary to identify individuals are not included in
data files used for analysis. These files are indexed by code numbers.
Code numbers and complete identifiers are linked only if there is a
specific need, such as for data verification.
Contractors, grantees or collaborators who maintain records in this
system are instructed to make no further disclosure of the records
except as authorized by the system manager and permitted by the Privacy
Act. Privacy Act requirements are specifically included in contracts
and in agreements with grantees or collaborators participating in
research activities supported by this system. HHS project director,
contract officers and project officers oversee compliance with these
requirements.
The particular safeguards implemented at each site are developed in
accordance with Chapter 45-13, ``Safeguarding Records Contained in
Systems of Records,'' of the HHS General Administration Manual,
supplementary Chapter PHS.hf: 45-13, and Part 6, ``ADP Systems
Security'', of the HHS Information Resources Management Manual and the
National Institute of Standards and Technology Federal Information
Processing Standards (FIPS Pub. 41 and FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3, which allows records to be kept as long
as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
Associate Director, Surveillance Program, DCPC, National Cancer
Institute, Executive Plaza North, Room 343K, 6130 Executive Blvd, MSC
7350, Bethesda, MD 20892-7350
and
Director, Women's Health Initiative, Office of the Director, National
Institutes of Health, Building 1, Room 260, 9000 Rockville Pike,
Bethesda, MD 20892
To determine if a file exists, write to the appropriate system
manager and provide the following information:
a. System name: ``Biomedical Research Records of Subjects: (1)
Cancer Studies of the Division of Cancer Prevention and Control, HHS/
NIH/NCI; and (2) Women's Health Initiative Studies, HHS/NIH/OD.''
b. Complete name at time of participation;
c. Facility and home address at the time of participation;
d. In some cases, where records are retrieved by an identifying
number, such as the Social Security Number or Hospital Identification
Number, it may be necessary to provide that number. In some cases, to
ensure proper identification it may be necessary to provide date(s) of
participation (if known), birth date, disease type (if known), and
study name and location (if known).
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a maximum fine of five thousand dollars.
Individuals seeking notification of or access to medical records
should designate a representative (including address) who may be a
physician, other health professional, or other responsible individual,
who would be willing to review the record and inform the subject
individual of its contents, at the representative's discretion.
A parent or guardian who requests notification of, or access to, a
child's or incompetent person's medical record shall designate a family
physician or other health professional (other than a family member) to
whom the record, if any, will be sent. The parent or guardian must
verify relationship to the child or incompetent person as well as his
or her own identity.
Write to the appropriate system manager and provide the same
information as requested under the notification procedure above.
Requesters should also reasonably specify the record contents being
sought. Individuals may also request listings of accountable
disclosures that have been made of their records, if any.
Write to the appropriate system manager, identify the record, and
specify the information contested. State the corrective action sought
and your reasons for requesting the correction, and provide supporting
information to show that the record is inaccurate, incomplete,
irrelevant, untimely, or unnecessary. The right to contest records is
limited to information which is incomplete, irrelevant, incorrect, or
untimely (obsolete).
HHS agencies, institutions under contract to the U.S. Government,
such as universities, medical schools, hospitals, research
institutions, commercial institutions, state agencies, other U.S.
Government agencies, patients and normal volunteers, physicians,
research investigators and other collaborating personnel.
None.
02-25-0156
Records of Participants in Programs and Respondents in Surveys Used
to Evaluate Programs of the Public Health Service, HHS/PHS/NIH/OD.
None.
This system of records is an umbrella system comprising separate
sets of records located either in the organizations responsible for
conducting evaluations or at the sites of programs or activities under
evaluation. Locations include Public Health (PHS) facilities, or
facilities of contractors of the PHS. Write to the appropriate System
Manager below for a list of current locations. [[Page 4278]]
Individuals covered by this system are those who provide
information or opinions that are useful in evaluating programs or
activities of the PHS, other persons who have participated in or
benefitted from PHS programs or activities; or other persons included
in evaluation studies for purposes of comparison. Such individuals may
include (1) participants in research studies; (2) applicants for and
recipients of grants, fellowships, traineeships or other awards; (3)
employees, experts and consultants; (4) members of advisory committees;
(5) other researchers, health care professionals, or individuals who
have or are at risk of developing diseases or conditions studied by
PHS; (6) persons who provide feedback about the value or usefulness of
information they receive about PHS programs, activities or research
results; (7) persons who have received Doctorate level degrees from
U.S. institutions; (8) persons who have worked or studied at U.S.
institutions that receive(d) institutional support from PHS.
This umbrella system of records covers a varying number of separate
sets of records used in different evaluation studies. The categories of
records in each set depend on the type of program being evaluated and
the specific purpose of the evaluation. In general, the records contain
two types of information: (1) Information identifying subject
individuals, and (2) information which enables PHS to evaluate its
programs and services.
(1) Identifying information usually consists of a name and address,
but it might also include a patient identification number, grant
number, Social Security Number, or other identifying number as
appropriate to the particular group included in an evaluation study.
(2) Information used for evaluation varies according to the program
evaluated. Categories of evaluative information include personal data
and medical data on participants in clinical and research programs;
personal data, publications, professional achievements and career
history of researchers; and opinions and other information received
directly from individuals in evaluation surveys and studies of PHS
programs.
The system does not include any master list, index or other central
means of identifying all individuals whose records are included in the
various sets of records covered by the system.
Authority for this system comes from the authorities regarding the
establishment of the National Institutes of Health, its general
authority to conduct and fund research and to provide training
assistance, and its general authority to maintain records in connection
with these and its other functions (42 U.S.C. 203, 241, 2891-1 and 44
U.S.C. 3101), and section 301 and 493 of the Public Health Service Act.
This system supports evaluation of the policies, programs,
organization, methods, materials, activities or services used by PHS in
fulfilling its legislated mandate for (1) conduct and support of
biomedical research into the causes, prevention and cure of diseases;
(2) support for training of research investigators; (3) communication
of biomedical information.
This system is not used to make any determination affecting the
rights, benefits or privileges of any individual.
1. Disclosure may be made to HHS contractors and collaborating
researchers, organizations, and State and local officials for the
purpose of conducting evaluation studies or collecting, aggregating,
processing or analyzing records used in evaluation studies. The
recipients are required to protect the confidentiality of such records.
2. Disclosure may be made to organizations deemed qualified by the
Secretary to carry out quality assessments, medical audits or
utilization review.
3. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
4. The Department may disclose information from this system of
records to the Department of Justice, to court or other tribunal, or to
another party before such tribunal, when (a) HHS, or any component
thereof; or (b) any HHS employee in his or her official capacity; or
(c) any HHS employee in his or her individual capacity where the
Department of Justice (or HHS, where it is authorized to do so) has
agreed to represent the employee; or (d) the United States or any
agency thereof where HHS or any of its components, is a party to
litigation or has an interest in such litigation, and HHS determines
that the use of such records by the Department of Justice, the
tribunal, or the other party is relevant and necessary to the
litigation and would help in the effective representation of the
governmental party, provided, however, that in each case, HHS
determines that such disclosure is compatible with the purpose for
which the records were collected.
Data may be stored in file folders, bound notebooks, or computer-
accessible media (e.g., magnetic tapes or discs).
Information is retrieved by name and/or participant identification
number within each evaluation study. There is no central collection of
records in this system, and no central means of identifying individuals
whose records are included in the separate sets of records that are
maintained for particular evaluation studies.
A variety of safeguards are implemented for the various sets of
records in this system according to the sensitivity of the data each
set contains. Information already in the public domain, such as titles
and dates of publications, is not restricted. However, sensitive
information, such as personal or medical history or individually
identified opinions, is protected according to its level of
sensitivity. Records derived from other systems of records will be
safeguarded at a level at least as stringent as that required in the
original systems. Minimal safeguards for the protection of information
which is not available to the general public included the following:
1. Authorized users: Regular access to information in a given set
of records is limited to PHS or to contractor employees who are
conducting, reviewing or contributing to a specific evaluation study.
Other access is granted only on a case-by-case basis, consistent with
the restrictions required by the Privacy Act (e.g., when disclosure is
required by the Freedom of Information Act), as authorized by the
system manager or designated responsible official.
2. Physical safeguards: Records are stored in closed or locked
containers, in areas which are not accessible to unauthorized users,
and in facilities which are locked when not in use. Records collected
in each evaluation project are maintained separately from
[[Page 4279]] those of other projects. Sensitive records are not left
exposed to unauthorized persons at any time. Sensitive data in machine-
readable form may be encrypted.
3. Procedural safeguards: Access to records is controlled by
responsible employees and is granted only to authorized individuals
whose identities are properly verified. Data stored in mainframe
computers is accessed only through the use of keywords known only to
authorized personnel. When personal computers are used, magnetic media
(e.g. diskettes) are protected as under Physical Safeguards. When data
is stored within a personal computer (i.e., on a ``hard disk''), the
machine itself is treated as though it were a record, or records, under
Physical Safeguards. Contracts for operation of this system of records
require protection of the records in accordance with these safeguards;
PHS project and contracting officers monitor contractor compliance.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and Part 6, ``ADP Systems Security,'' of the HHS Information Resources
Management Manual and the National Institute of Standards and
Technology Federal Information Processing Standards (FIPS Pub. 41 and
FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 1100-C-2. Refer to the NIH Manual Chapter for
specific disposition instructions.
See Appendix 1.
Policy coordination for this system is provided by:
Associate Director, Office of Strategic Planning and Evaluation, Office
of Science Policy and Technology Transfer, National Institutes of
Health, 6006 Executive Boulevard, Suite 312, Rockville, MD 20892
To determine if a record exists, write to the official of the
organization responsible for the evaluation, as listed in Appendix 2.
If you are not certain which component of PHS was responsible for the
evaluation study, or if you believe there are records about you in
several components of PHS, write to:
NIH Privacy Act Officer, Building 31, Room 1B25, 9000 Rockville Pike,
Bethesda, MD 20892.
Requesters must provide the following information:
1. Full name, and name(s) used while studying or employed;
2. Name and location of the evaluation study or other PHS program
in which the requester participated or the institution at which the
requester was a student or employee, if applicable;
3. Approximate dates of participation, matriculation or employment,
if applicable.
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
An individual who requests notification of or access to a medical
record shall, at the time the request is made, designate in writing, a
responsible representative, who may be a physician, other health
professional, or other responsible individual, who will be willing to
review the record and inform the subject individual of its contents at
the representative's discretion.
A parent or guardian who requests notification of, or access to, a
child's or incompetent person's medical record shall designate a family
physician or other health professional (other than a family member) to
whom the record, if any, will be sent. The parent or guardian must
verify relationship to the child or incompetent person as well as his
or her own identity.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Write to the official specified under notification procedures
above, and reasonably identify the record and specify the information
being contested, the corrective action sought, and your reasons for
requesting the correction, along with supporting information to show
how the record is inaccurate, incomplete, untimely or irrelevant. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
Information contained in these records is obtained directly from
individual participants; from systems of records 09-25-0036, ``Grants:
IMPAC (Grants/Contract Information), HHS/NIH/DRG;'' 09-25-0112,
``Grants: Research, Research Training, Fellowship and Construction
Applications and Awards, HHS/NIH/OD''; NSF-6, ``Doctorate Record
File'', NSF-43, ``Doctorate Work History File'' (previously entitled
NSF-43, ``Roster and Survey of Doctorate Holders in The United States''
and other records maintained by the operating programs of NIH; the
National Academy of Sciences, professional associations such as the
AAMC and ADA, and other contractors; grantees or collaborating
researchers; or publicly available sources such as bibliographies.
None.
Appendix 1: System Managers
Associate Director, Office of Strategic Planning and Evaluation,
Office of Science Policy and Technology Transfer, National
Institutes of Health, 6006 Executive Boulevard, Suite 312,
Rockville, MD 20892
National Institutes of Health, Office of the Director, Director,
Division of Personnel Management, Building 1, Room B1-60, 9000
Rockville Pike, Bethesda, MD 20892
National Heart, Lung, and Blood Institute (NHLBI), NHLBI Minority
Coordinate, OD, OPPE, Building 31, Room 5A03/5A06, 31 Center Drive,
MSC 2482, Bethesda, MD 20892-2482
National Library of Medicine (NLM), Associate Director for Health
Information Programs Development, Building 38, Room 2S20, Bethesda,
MD 20894
National Eye Institute (NEI), Associate Director for Science Policy
and Legislation, Building 31, Room 6A25, Bethesda, MD 20892
National Cancer Institute (NCI), Public Health Educator, OCC, NCI,
National Institutes of Health Building 31, Room 4B43, Bethesda, MD
20892
National Institute on Aging (NIA), Chief, Office of Planning,
Analysis, Technical Information and Evaluation, Federal Building,
Room 6A09, 7550 Wisconsin Avenue, Bethesda, MD 20892
National Institute of Allergy and Infectious Diseases (NIAID),
Chief, Evaluation and Reporting Section, Policy Analysis and
Legislation Branch, Office of Administration Management, Building
31, Room 7A-16, Bethesda, MD 20892
National Institute of Child Health and Human Development (NICHD),
Chief, Office of Science Policy and Analysis, Building 31, Room
2A10, Bethesda, MD 20892 [[Page 4280]]
National Institute on Deafness and Other Communications Disorders,
Chief, Program Planning and Health Reports Branch, Building 31, room
3C35, 9000 Rockville Pike, Bethesda, MD 20892
National Institute of Dental Research (NIDR), Director, Office of
Planning Evaluation, and Communications, Building 31, Room 2C34, 31
Center Drive MSC 2290,Bethesda, MD 20892-2290
National Institute of Environmental Health Sciences (NIEHS)
Programs, Analyst, Office of Program Planning and Evaluation, P.O.
Box 12233, Research Triangle Park, NC 27709
National Institute of General Medical Sciences (NIGMS), Chief,
Office of Program Analysis and Evaluation, Natcher Building, Room
3AS49, 9000 Rockville Pike, Bethesda, MD 20892
Fogarty International Center (FIC), National Institutes of Health,
Assistant Director for Planning, Evaluation and Public Affairs,
Building 31, Room B2C32, Bethesda, MD 20892
Division of Research Grants (DRG), Assistant Director for Special
Projects, Westwood Building, Room 457, 5333 Westbard Avenue,
Bethesda, MD 20892
National Center for Research Resources (NCRR), Evaluation Officer,
Office of Science Policy, Westwood Building, Room 8A03, Bethesda, MD
20892
National Institute of Nursing Research (NINR), Chief, Office of
Planning, Analysis and Evaluation, Building 31, Room 5B09, Bethesda,
MD 20892
Office of Research Integrity, Policy Analyst, Division of Policy and
Education, U.S. Public Health Service, 5515 Security Lane, Suite
700, Rockwell-II Building, Rockville, MD 20852
Appendix 2: Notification and Access Officials
NIH, Office of the Director, Associate Director for Science, Policy
and Legislation, Building 1, Room 137, 9000 Rockville Pike,
Bethesda, MD 20892
National Institutes Health, Office of the Director, Director,
Division of Personnel Management, Building 1, Room B1-60, 9000
Rockville Pike, Bethesda, MD 20892
National Heart, Lung, and Blood Institute (NHLBI), Privacy Act
Coordinator, Building 31, Room 5A29, Bethesda, MD 20892
National Library of Medicine (NLM), Assistant Director for Planning
and Evaluation, Building 38, Room 2S18, Bethesda, MD 20894
National Eye Institute (NEI), Executive Officer, Building 31, Room
6A25, Bethesda, MD 20892
Fogarty International Center (FIC), National Institutes of Health,
Assistant Director for Planning, Evaluation and Public Affairs,
Building 31, Room B2C32, Bethesda, MD 20892
Division or Research Grants (DRG), Assistant Director for Special
Projects, Westwood Building, Room 457, 5333 Westbard Avenue,
Bethesda, MD 20892
National Center of Research Resources (NCRR), Evaluation Officer,
Office of Science Policy, NIH, Westwood Building, Room 8A03,
Bethesda, MD 20892
National Cancer Institute, Privacy Act Coordinator, National
Institutes of Health, Building 31, Room 10A30, Bethesda, MD 20892
02-25-0156
Records of Participants in Programs and Respondents in Surveys Used
to Evaluate Programs of the National Institutes of Health, HHS/NIH/OD.
None.
This system of records is an umbrella system comprising separate
sets of records located either in the organizations responsible for
conducting evaluations or at the sites of programs or activities under
evaluation. Locations include National Institutes of Health (NIH)
facilities in Bethesda, Maryland, or facilities of contractors of the
NIH. Write to the appropriate System Manager below for a list of
current locations.
Individuals covered by this system are those who provide
information or opinions that are useful in evaluating programs or
activities of the NIH, other persons who have participated in or
benefitted from NIH programs or activities; or other persons included
in evaluation studies for purposes of comparison. Such individuals may
include (1) participants in research studies; (2) applicants for and
recipients of grants, fellowships, traineeships or other awards; (3)
employees, experts and consultants; (4) members of advisory committees;
(5) other researchers, health care professionals, or individuals who
have or are at risk of developing diseases or conditions studied by
NIH; (6) persons who provide feedback about the value or usefulness of
information they receive about NIH programs, activities or research
results; (7) persons who have received Doctorate level degrees from
U.S. institutions; (8) persons who have worked or studied at U.S.
institutions that receive (d) institutional support from NIH.
This umbrella system of records covers a varying number of separate
sets of records used in different evaluation studies. The categories of
records in each set depend on the type of program being evaluated and
the specific purpose of the evaluation. In general, the records contain
two types of information: (1) information identifying subject
individuals, and (2) information which enables NIH to evaluate its
programs and services.
(1) Identifying information usually consists of a name and address,
but it might also include a patient identification number, grant
number, Social Security Number, or other identifying number as
appropriate to the particular group included in an evaluation study.
(2) Information used for evaluation varies according to the program
evaluated. Categories of evaluative information include personal data
and medical data on participants in clinical and research programs;
personal data, publications, professional achievements and career
history of researchers; and opinions and other information received
directly from individuals in evaluation surveys and studies of NIH
programs.
The system does not include any master list, index or other central
means of identifying all individuals whose records are included in the
various sets of records covered by the system.
Authority for this system comes from the authorities regarding the
establishment of the National Institutes of Health, its general
authority to conduct and fund research and to provide training
assistance, and its general authority to maintain records in connection
with these and its other functions (42 U.S.C. 203, 241, 289l-1 and 44
U.S.C. 3101).
This system supports evaluation of the policies, programs,
organization, methods, materials, activities or services used by NIH in
fulfilling its legislated mandate for (1) conduct and support of
biomedical research into the causes, prevention and cure of diseases;
(2) support for training of research investigators; (3) communication
of biomedical information.
This system is not used to make any determination affecting the
rights, benefits or privileges of any individual.
1. Disclosure may be made to HHS contractors and collaborating
researchers, organizations, and State and local officials for the
purpose of conducting evaluation studies or collecting, aggregating,
processing or analyzing records used in evaluation studies. The
recipients are required to protect the confidentiality of such records.
2. Disclosure may be made to organizations deemed qualified by the
[[Page 4281]] Secretary to carry out quality assessments, medical
audits or utilization review.
3. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
4. The Department may disclose information from this system or
records to the Department of Justice, to court or other tribunal, or to
another party before such tribunal, when (a) HHS, or any component
thereof; or (b) any HHS employee in his or her official capacity; or
(c) any HHS employee in his or her individual capacity where the
Department of Justice (or HHS, where it is authorized to do so) has
agreed to represent the employee; or (d) the United States or any
agency thereof where HHS or any of its components, is a party to
litigation or has an interest in such litigation, and HHS determines
that the use of such records by the Department of Justice, the
tribunal, or the other party is relevant and necessary to the
litigation and would help in the effective representation of the
governmental party, provided, however, that in each case, HHS
determines that such disclosure is compatible with the purpose for
which the records were collected.
Data may be stored in file folders, bound notebooks, or computer-
accessible media (e.g., magnetic tapes or discs).
Information is retrieved by name and/or participant identification
number within each evaluation study. There is no central collection of
records in this system, and no central means of identifying individuals
whose records are included in the separate sets of records that are
maintained for particular evaluation studies.
A variety of safeguards are implemented for the various sets of
records in this system according to the sensitivity of the data each
set contains. information already in the public domain, such as titles
and dates of publications, is not restricted. However, sensitive
information, such as personal or medical history or individually
identified opinions, is protected according to its level of
sensitivity. Records derived from other systems of records will be
safeguarded at a level at least as stringent as that required in the
original systems. Minimal safeguards for the protection of information
which is not available to the general public include the following:
1. Authorized users: Regular access to information in a given set
of records is limited to NIH or to contractor employees who are
conducting, reviewing or contributing to a specific evaluation study.
Other access is granted only on a case-by-case basis, consistent with
the restrictions required by the Privacy Act (e.g., when disclosure is
required by the Freedom of Information Act), as authorized by the
system manager or designated responsible official.
2. Physical safeguards: Records are stored in closed or locked
containers, in areas which are not accessible to unauthorized users,
and in facilities which are locked when not in use. Records collected
in each evaluation project are maintained separately from those of
other projects. Sensitive records are not left exposed to unauthorized
persons at any time. Sensitive data in machine-readable form may be
encrypted.
3. Procedural safeguards: Access to records is controlled by
responsible employees and is granted only to authorized individuals
whose identities are properly verified. Data stored in mainframe
computers is accessed only through the use of keywords known only to
authorized personnel. When personal computers are used, magnetic media
(e.g. diskettes) are protected as under Physical Safeguards. When data
is stored within a personal computer (i.e., on a ``hard disk''), the
machine itself is treated as though it were a record, or records, under
Physical Safeguards. Contracts for operation of this system of records
require protection of the records in accordance with these safeguards;
NIH project and contracting officers monitor contractor compliance.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and Part 6, ``ADP Systems Security,'' of the HHS Information Resources
Management Manual and the National Institute of Standards and
Technology Federal Information Processing Standards (FIPS Pub. 41 and
FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 1100-C-2. Refer to the NIH Manual Chapter for
specific disposition instructions.
See Appendix 1.
Policy coordination for this system is provided by:
Associate Director, Office of Strategic Planning and Evaluation, Office
of Science Policy and Technology Transfer, National Institutes of
Health, 6006 Executive Boulevard, Suite 312, Rockville, MD 20892.
To determine if a record exists, write to the official of the
organization responsible for the evaluation, as listed in Appendix 2.
If you are not certain which component of NIH was responsible for the
evalaution study, or if you believe there are records about you in
several components of NIH, write to:
NIH Privacy Act Officer, Building 31, Room 1B25, 9000 Rockville Pike,
Bethesda, MD 20892.
Requesters must provide the following information:
1. Full name, and name(s) used while studying or employed;
2. Name and location of the evaluation study or other NIH program
in which the requester participated or the institution at which the
requester was a student or employee, if applicable;
3. Approximate dates of participation, matriculation or employment,
if applicable.
The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine.
An individual who requests notification of or access to a medical
record shall, at the time the request is made, designate in writing, a
responsible representative, who may be a physician, other health
professional, or other responsible individual, who will be willing to
review the record and inform the subject individual of its contents at
the representative's discretion.
A parent or guardian who requests notification of, or access to, a
child's or incompetent person's medical record shall designate a family
physician or [[Page 4282]] other health professional (other than a
family member) to whom the record, if any, will be sent. The parent or
guardian must verify relationship to the child or incompetent person as
well as his or her own identity.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
listings of accountable disclosures that have been made of their
records, if any.
Write to the official specified under notification procedures
above, and reasonably identify the record and specify the information
being contested, the corrective action sought, and your reasons for
requesting the correction, along with supporting information to show
how the record is inaccurate, incomplete, untimely or irrelevant. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
Information contained in these records is obtained directly form
individual participants; from systems of records 09-25-0036, ``Grants:
IMPAC (Grants/Contract Information), HHS/NIH/DRG;'' 09-25-0112,
``Grants: Research, Research Training, Fellowship and Construction
Applications and Awards, HHS/NIH/OD''; NSF-6, ``Doctorate Record
File'', NSF-43, ``Doctorate Work History File'' (previously entitled
NSF-43, ``Roster and Survey of Doctorate Holders in the United States''
and other records maintained by the operating programs of NIH: the
National Academy of Sciences, professional associations such as the
AAMC and ADA, and other contractors; grantees or collaborating
researchers; or publicly available sources such as bibliographies.
None.
Appendix 1: System Managers
Associate Director, Office of Strategic Planning and Evaluation,
Office of Science Policy and Technology Transfer, National
Institutes of Health, 6006 Executive Boulevard, Suite 312,
Rockville, MD 20892
National Institutes of Health, Office of the Director, Director,
Division of Personnel Management, Building 1, Room B1-60, 9000
Rockville Pike, Bethesda, MD 20892
National Heart, Lung, and Blood Institute (NHLBI), NHLBI Minority
Coordinator, Building 31, Room 5A07, Bethesda, MD 20892
National Library of Medicine (NLM), Associate Director for Health
Information Programs Development, Building 38, Room 2S28, Bethesda,
MD 20894
National Eye Institute (NEI), Associate Director for Science Policy
and Legislation, Building 31, Room 6A25, Bethesda, MD 20892
National Cancer Institute (NCI), Public Health Educator, OCC, NCI,
National Institutes of Health Building 31, Room 4B43, Bethesda, MD
20892
National Institute on Aging (NIA), Chief, Office of Planning,
Analysis, Technical Information and Evaluation, Federal Building,
Room 6A09, 7550 Wisconsin Avenue, Bethesda, MD 20892
National Institute of Allergy and Infectious Diseases (NIAID),
Acting Director, Office of Policy Analysis and Technology Transfer,
Building 31, Room 7A-52, Bethesda, MD 20892
National Institute of Child Health and Human Development (NICHD),
Chief, Office of Science Policy and Analysis, Building 31, Room
2A10, Bethesda, MD 20892
National Institute on Deafness and Other Communication Disorders,
Chief, Program Planning and Health Reports Branch, Building 31, Room
3C36, 9000 Rockville Pike, Bethesda, MD 20892
National Institute of Dental Research (NIDR), Chief, Office of
Planning Evaluation, and Communications, Building 31, Room 2C35,
Bethesda, MD 20892
National Institute of Environmental Health Sciences (NIEHS) Program,
Analyst, Office of Program Planning and Evaluation, P.O. Box 12233,
Research Triangle Park, N.C. 27709
National Institute of General Medical Sciences (NIGMS), Chief,
Office of Program Analysis, Westwood Building, Room 934, 5333
Westbard Avenue, Bethesda, MD 20892
Fogarty International Center (FIC), National Institutes of Health,
Assistant Director for Planning, Evaluation and Public Affairs,
Building 31, Room B2C32, Bethesda, MD 20892
National Center for Research Resources (NCRR), Evaluation Officer,
Office of Science Policy, Westwood Building, Room 8A03, Bethesda, MD
20892
National Institute of Nursing Research (NINR), Chief, Office of
Planning, Analysis and Evaluation, Building 31, Room 5B09, Bethesda,
MD 20892
Appendix 2: Notification and Access Officials
NIH, Office of the Director, Associate Director for Science, Policy
and Legislation, Building 1, Room 137, 9000 Rockville Pike,
Bethesda, MD 20892
National Institutes of Health, Office of the Director, Director,
Division of Personnel Management, Building 1, Room B1-60, 9000
Rockville Pike, Bethesda, MD 20892
National Heart, Lung, and Blood Institute (NHLBI), Privacy Act
Coordinator, Building 31 Room 5A29, Bethesda, MD 20892
National Library of Medicine (NLM), Associate Director for Health
Information Programs Development, Building 38, Room 2S28, Bethesda,
MD 20894
National Eye Institute (NEI), Executive Officer, Building 31, Room
6A25, Bethesda, MD 20892
Fogarty International Center (FIC), National Institutes of Health,
Assistant Director for Planning, Evaluation and Public Affairs,
Building 31, Room B2C32, Bethesda, MD 20892
Division of Research Grants (DRG), Assistant Director for Special
Projects, Westwood Building, Room 457, 5333 Westbard Avenue,
Bethesda, MD 20892
National Center for Research Resources (NCRR), Evaluation Officer,
Office of Science Policy, NIH, Westwood Building, Room 8A03,
Bethesda, MD 20892
National Cancer Institute, Privacy Act Coordinator, National
Institutes of Health, Building 31, Room 10A30, Bethesda, MD 20892
09-25-0161
Administration: NIH Consultant File, HHS/NIH/DRG.
None.
This system of records is an umbrella system comprising separate
sets of records located in each of the NIH organizational components or
facilities of contractors of the NIH.
Division of Computer Research and Technology, Data Management Branch,
Building 12A, Room 4041B, National Institutes of Health, Bethesda,
Maryland 20892
Write to the appropriate system manager listed in Appendix I for a list
of current locations.
Consultants who provide the evaluation of extramural grants and
cooperative agreement applications and research contract proposals,
including the NIH Reviewers' Reserve and/or advise on policy.
Consultants who participate in NIH conferences, workshops, evaluation
projects and/or provide technical assistance at site locations arranged
by contractors.
Names, addresses, Social Security numbers, resumes, curriculum
vitae (C.V.s), areas of expertise, gender, minority status, business
status. AREA-eligible status, publications, travel records, and payment
records for consultants.
Section 301 of the Public Health Service Act, describing the
general [[Page 4283]] powers and duties of the Public Health Service
relating to research and investigation, and section 402 of the Public
Health Service Act, describing the appointment and authority of the
Director of the National Institutes of Health, (42 U.S.C. 241, 282 and
290 aa).
This umbrella system comprises separate sets of records located in
each of the NIH organizational components or facilities of contractors
of the NIH. These records are used: (1) To identify and select experts
and consultants for program reviews and evaluations; (2) To identify
and select experts and consultants for the review of special grant and
cooperative agreement applications and research contract proposals and
(3) To obtain and pay consultants who participate in NIH conferences,
workshops, evaluation projects and/or provide technical assistance at
site locations arranged by contractors, and (4) To provide necessary
reports related to payment to the Internal Revenue Service.
1. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
2. Disclosure may be made to the Department of Justice or to a
court or other tribunal from this system of records, when (a) HHS, or
any component thereof; or (b) any HHS employee in his or her official
capacity; or (c) any HHS employee; or (d) the United States or any
agency thereof where HHS determines that the litigation is likely to
affect HHS or any of its components, is a party to litigation or has an
interest in such litigation, and HHS determines that the use of such
records by the Department of Justice, court or other tribunal is
relevant and necessary to the litigation and would help in the
effective representation of the governmental party, provided, however,
that in each case HHS determines that such disclosure is compatible
with the purpose for which the records were collected.
3. Disclosure may be made to contractors to process or refine the
records. Contracted services may include transcription, collection,
computer input, and other records processing.
4. Information in this system of records is used routinely to
prepare W-2 and 1099 Forms to submit to the Internal Revenue Service
and applicable State and local governments those items to be included
as income to an individual.
Records may be stored in file folders, computer tapes and disks,
microfiche, and microfilm.
Records are retrieved by name, expertise, gender, minority status,
business status, AREA-eligible status and experimental system used.
1. Authorized users: Data on computer files is accessed by keyword
known only to authorized users who are PHS or contractor employees
involved in managing a review or program advisory committee, conducting
a review of extramural grant applications, cooperative agreement
applications, or research contract proposals, performing an evaluation
study or managing the consultant file. Access to information is thus
limited to those with a need to know.
2. Physical safeguards: Room where records are stored are locked
when not in use. During regular business hours rooms are unlocked but
are controlled by on-site personnel.
3. Procedural safeguards: Names and other identifying particulars
are deleted when data from original records are encoded for analysis.
Data stored in computers is accessed through the use of keywords known
only to authorized users. Contractors who maintain records in this
system are instructed to make no further disclosure of the records
except as authorized by the system manager and permitted by the Privacy
Act.
This system of records will be protected according to the standards
of Chapter 45-13 of the HHS General Administration Manual,
``Safeguarding Records Contained in Systems of Records,'' supplementary
Chapter PHS hf: 45-13, and Part 6, ``ADP Systems Security,'' of the HHS
Information Resources Management Manual and the National Institute of
Standards and Technology Federal Information Processing Standards (FIPS
Pub. 41 and FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 1100-G. Refer to the NIH Manual Chapter for
specific disposition instructions.
The policy coordinator for this system is also the system manager
listed for the Division of Research Grants.
Chief, Biological and Physiological Sciences Review Section, Referral
and Review Branch, Division of Research Grants, Westwood Building, Room
417, 5333 Westbard Avenue, Bethesda, Maryland 20892
and
See Appendix I
To determine if a record exists, write to the appropriate system
manager as listed in Appendix I.
The Requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requestor is whom he or she claims to be. The request should
include: (a) Full name, and (b) appropriate dates of participation.
Same as notification procedures. Requestors should also reasonably
specify the record contents being sought. Individuals may also request
listing of accountable disclosures that have been made of their
records, if any.
Contact the official under notification procedures above,
reasonably identify the record, specify the information to be
contested, and state the corrective action sought with supporting
information. The right to contest records is limited to information
which is incomplete, irrelevant, incorrect, or untimely (obsolete).
Subject individual.
None.
Appendix I: System Managers
Office of the Director (OD), Extramural Programs Management Officer,
Building 31, Room 5B31, Bethesda, MD 20892
National Center for Research Resources (NCRR), Director, Office of
Review, Westwood Building, Room 8A16, Bethesda, MD 20892
National Cancer Institute (NCI), Chief, Review Logistics Branch,
Executive Plaza North, Room 636, Bethesda, MD 20892
National Eye Institute (NEI), Review and Special Projects Officer,
Executive Plaza South, Room 350, Bethesda, MD 20892
National Heart, Lung, and Blood Institute (NHLBI), Chief, Review
Branch, Westwood [[Page 4284]] Building, Room 557A, 5333 Westbard
Avenue, Bethesda, MD 20892
National Institute on Aging (NIA), Chief, Scientific Review Office,
Gateway Building, Suite 2C212, 7201 Wisconsin Avenue, Bethesda, MD
20892
National Institute of Allergy and Infectious Diseases (NIAID),
Director, Scientific Review Program, Division of Extramural
Activities, Solar Bldg., Room 3C-16, 6003 Executive Blvd., Bethesda,
MD 20892
National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS), Chief, Grants Review Branch, Natcher Building,
Room 5AS-25U, Bethesda, MD 20892
National Institute of Child Health and Human Development (NICHD),
Director, Division of Scientific Review, 6100 Executive Boulevard,
Room 5E03H, Bethesda, MD 20892
National Institute on Deafness and Other Communication Disorders
(NIDCD), Chief, Scientific Review Branch, Executive Plaza South,
Room 400B, 620 Executive Boulevard, Rockville, MD 20852
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), Chief, Review Branch, Natcher Building, Room 6AS-37F,
Bethesda, MD 20892
National Institute of Dental Research (NIDR), Chief, Scientific
Review Section, POB, Natcher Building, Room 4AN-38D, 45 Center Drive
MSC 6402, Bethesda, MD 20892-6402
National Institute of Environmental Health Sciences (NIEHS), Chief,
Scientific Review Branch, Division of Extramural Research and
Training, P.O. Box 12233, Research Triangle Park, NC 27709
National Institute of General Medical Sciences (NIGMS), Chief,
Office of Scientific Review, Natcher Building, Room 1AS-13F,
Bethesda, MD 20892
National Institute of Neurological Disorders and Stroke (NINDS),
Chief, Scientific Review Branch, Federal Building, Room 9C10A,
Bethesda, MD 20892
National Institute of Nursing Research (NINR), Chief, Office of
Review, Natcher Building, Room 3AN24 MSC 6302, Bethesda, MD 20892-
6302
National Library of Medicine (NLM), Chief, Biomedical Information
Support Branch, Building 38A, Room 5S522, Bethesda, MD 20894
National Center for Human Genome Research (NCHGR), Chief, Office of
Scientific Review, Building 38A, Room 604, Bethesda, MD 20892
National Institute of Mental Health, Associate Director for Program
Coordination, Division of Extramural Activities, Parklawn Building,
Room 9C-15, 5600 Fishers Lane, Rockville, MD 20857
National Institute on Alcohol Abuse and Alcoholism, Committee
Management Officer, Willco Building, Suite 504, 6000 Executive Blvd
MSC 7003, Bethesda, MD 20892-7003
National Institute on Alcohol Abuse and Alcoholism, Deputy Director,
Office of Scientific Affairs, Willco Building, Suite 409, 6000
Executive Blvd. MSC 7003, Bethesda, MD 20892-7003
National Institute on Drug Abuse, Office of Extramural Program
Review, Parklawn Building, Room 10-42, 5600 Rishers Lane, Rockville,
MD 20857
09-25-0165
National Institutes of Health Loan Repayment Program, HHS/NIH/OD.
None.
Loan Repayment Program (LRP), Office of the Director, National
Institutes of Health, Federal Building, Room 102, 7550 Wisconsin
Avenue, Bethesda, Maryland 20892-9015
Division of Computer Research and Technology (DCRT), National
Institutes of Health, Building 12A, Room 4037, 9000 Rockville Pike,
Bethesda, Maryland 20892
Operations Accounting Branch, Division of Financial Management (DFM),
National Institutes of Health, Building 31, Room B1B55, 9000 Rockville
Pike, Bethesda, Maryland 20892
See Appendix I for a listing of other NIH offices responsible for
administration of the Loan Repayment Program. Write to the System
Manager at the address below for the address of any Federal Records
Center where records from this system may be stored.
Individuals who have applied for, who have been approved to
receive, who are receiving, and who have received funds under the NIH
LRP; and individuals who are interested in participation in the NIH
LRP.
Name, address, Social Security number; service pay-back
obligations, standard school budgets, educational loan data including
deferment and repayment/delinquent/default status information;
employment data; professional and credentialing history of licensed
health professionals including schools of attendance; personal,
professional, and demographic background information; employment status
verification (which includes certifications and verifications of
continuing participation in AIDS research); Federal, State and local
tax information, including copies of tax returns.
Section 487A (42 U.S.C. 288-1) of the PHS Act, as amended,
authorizes the NIH to implement a program of educational loan repayment
for qualified health professionals who agree to conduct, as employees
of NIH, AIDS research (the NIH AIDS Research LRP). The provisions of
section 338B of the PHS Act (42 U.S.C. 254l-1), as amended, governing
the NHSC loan repayment program, are incorporated except as
inconsistent. Section 487E (42 U.S.C. 288-5) of the PHS Act authorizes
the NIH to establish and implement a program of educational loan
repayment for qualified health professionals who agree to conduct, as
employees of the NIH, clinical research (the NIH Clinical Research
LRP). Eligibility for the Clinical Research LRP is restricted to
individuals who are from disadvantaged backgrounds. The provisions of
section 338C and 338E of the PHS Act (42 U.S.C. 254l-1), as amended,
governing the NHSC loan repayment program, are incorporated except as
inconsistent. The Internal Revenue Code at 26 U.S.C. 6109 requires the
provision of the SSN for the receipt of loan repayment funds under the
NIH LRP.
(1) To identify and select applicants for the NIH LRP; (2) To
monitor loan repayment activities, such as payment tracking, deferment
of service obligation, and default; and (3) To assist NIH officials in
the collection of overdue debts owed under the NIH LRP. Records may be
transferred to system No. 09-15-0045, ``Health Resources and Services
Administration Loan Repayment/Debt Management Records System, HHS/HRSA/
OA,'' for debt collection purposes when NIH officials are unable to
collect overdue debts owed under the NIH LRP.
1. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
2. Disclosure may be made to the Department of Justice or to a
court or other tribunal from this system of records, when (a) HHS, or
any component thereof; or (b) any HHS employee in his or her official
capacity; or (c) any HHS employee in his or her individual capacity
where the Department of Justice (or HHS, where it is authorized to do
so) has agreed to represent the employee; or (d) the United States of
any agency thereof where HHS determines that the litigation is likely
to affect HHS or any of its components, is a party to litigation or has
an interest in such litigation, and HHS determines that the use of such
records by the Department of Justice, [[Page 4285]] court or other
tribunal is relevant and necessary to the litigation and would help in
the effective representation of the governmental party, provided,
however, that in each case HHS determines that such disclosure is
compatible with the purpose for which the records were collected.
3. In the event that a system of records maintained by this agency
to carry out its functions indicates a violation or potential violation
of law, whether civil, criminal, or regulatory in nature, and whether
arising by general statute, or particular program statute, or by
regulation, rule or order issued pursuant thereto, the relevant records
in the system of records may be referred to the appropriate agency,
whether Federal, State, or local, charged with enforcing or
implementing the statute or rule, regulation or order issued pursuant
thereto.
4. NIH may disclose records to Department contractors and
subcontractors for the purpose of collecting, compiling, aggregating,
analyzing, or refining records in the system. Contractors maintain, and
are also required to ensure that subcontractors maintain, Privacy Act
safeguards with respect to such records.
5. NIH may disclose information from this system of records to
private parties such as present and former employers, references listed
on applications and associated forms, other references and educational
institutions. The purpose of such disclosures is to evaluate an
individual's professional accomplishments, performance, and educational
background, and to determine if an applicant is suitable for
participation in the NIH LRP.
6. NIH may disclose information from this system of records to a
consumer reporting agency (credit bureau) to obtain a commercial credit
report to assess and verify the ability of an individual to repay debts
owed to the Federal Government. Disclosures are limited to the
individual's name, address, Social Security number and other
information necessary to identify him/her; the funding being sought or
amount and status of the debt; and the program under which the
applicant or claim is being processed.
7. NIH may disclose from this system of records a delinquent
debtor's or a defaulting participant's name, address, Social Security
number, and other information necessary to identify him/her; the
amount, status, and history of the claim, and the agency or program
under which the claim arose, as follows:
a. To another Federal agency so that agency can effect a salary
offset for debts owed by Federal employees; if the claim arose under
the Social Security Act, the employee must have agreed in writing to
the salary offset.
b. To another Federal agency so that agency can effect an
unauthorized administrative offset; i.e., withhold money, other than
federal salaries, payable to or held on behalf of the individual.
c. To the Treasury Department, Internal Revenue Service (IRS), to
request an individual's current mailing address to locate him/her for
purposes of either collecting or compromising a debt, or to have a
commercial credit report prepared.
8. NIH may disclose information from this system of records to
another agency that has asked the Department to effect a salary or
administrative offset to help collect a debt owed to the United States.
Disclosure is limited to the individual's name, address, Social
Security number, and other information necessary to identify the
individual to information about the money payable to or held for the
individual, and other information concerning the offset.
9. NIH may disclose to the Treasury Department, Internal Revenue
Service (IRS), information about an individual applying for loan
repayment under any loan repayment program authorized by the Public
Health Service Act to find out whether the applicant has a delinquent
tax account. This disclosure is for the sole purpose of determining the
applicant's creditworthiness and is limited to the individual's name,
address, Social Security number, other information necessary to
identify him/her, and the program for which the information is being
obtained.
10. NIH may report to the Treasury Department, Internal Revenue
Service (IRS), as taxable income, the written-off amount of a debt owed
by an individual to the Federal Government when a debt becomes partly
or wholly uncollectible, either because the time period for collection
under the statute of limitations has expired, or because the Government
agrees with the individual to forgive or compromise the debt.
11. NIH may disclose to debt collection agents, other Federal
agencies, and other third parties who are authorized to collect a
Federal debt, information necessary to identify a delinquent debtor or
a defaulting participant. Disclosure will be limited to the
individual's name, address, Social Security number, and other
information necessary to identify him/her; the amount, status, and
history of the claim, and the agency or program under which the claim
arose.
12. NIH may disclose information from this system of records to any
third party that may have information about a delinquent debtor's or a
defaulting participant's current address, such as a U.S. post office, a
State motor vehicle administration, a professional organization, an
alumni association, etc., for the purpose of obtaining the individual's
current address. This disclosure will be strictly limited to
information necessary to identify the individual, without any reference
to the reason for the agency's need for obtaining the current address.
13. NIH may disclose information from this system of records to
other Federal agencies that also provide loan repayment at the request
of these Federal agencies in conjunction with a matching program
conducted by these Federal agencies to detect or curtail fraud and
abuse in Federal loan repayment programs, and to collect delinquent
loans or benefit payments owed to the Federal Government.
14. NIH may disclose from this system of records to the Department
of Treasury, Internal Revenue Service (IRS): (1) A delinquent debtor's
or a defaulting participant's name, address, Social Security number,
and other information necessary to identify the individual; (2) the
amount of the debt; and (3) the program under which the debt arose, so
that IRS can offset against the debt any income tax refunds which may
be due to the individual.
15. NIH may disclose information provided by a lender to other
Federal agencies, debt collection agents, and other third parties who
are authorized to collect a Federal debt. The purpose of this
disclosure is to identify an individual who is delinquent in loan or
benefit payments owed to the Federal Government.
Disclosures pursuant to 5 U.S.C. 552a(b)(12): Disclosures may be
made from this system to ``consumer reporting agencies'' as defined in
the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) or the Federal
Claims Collection Act of 1966 (31 U.S.C. 3701(a)(3)). The purposes of
these disclosures are: (1) To provide an incentive for debtors to repay
delinquent Federal Government debts by making these debts part of their
credit records, and (2) to enable NIH to improve the quality of loan
repayment decisions by taking into account the financial reliability of
applicants, including obtaining a commercial credit report to assess
and verify the ability of an individual to repay debts owed to the
Federal Government. Disclosure of records will be limited to the
individual's name, Social Security [[Page 4286]] number, and other
information necessary to establish the identity of the individual, the
amount, status, and history of the claim, and the agency or program
under which the claim arose.
Records are maintained in file folders, computer tape, discs, and
file cards.
Records are retrieved by name, Social Security number, or other
identifying numbers.
1. Authorized users: Data on computer files is accessed by keyword
known only to authorized users who are NIH employees responsible for
implementing the NIH LRP. Access to information is thus limited to
those with a need to know.
2. Physical safeguards: Rooms where records are stored are locked
when not in use. During regular business hours rooms are unlocked but
are controlled by on-site personnel. Security guards perform random
checks on the physical security of the data.
3. Procedural and technical safeguards: A password is required to
access the terminal and a data set name controls the release of data to
only authorized users. All users of personal information in connection
with the performance of their jobs (see Authorized Users, above)
protect information from public view and from unauthorized personnel
entering an unsupervised office.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
the Department's Automated Information System Security Handbook, and
the National Institute of Standards and Technology Federal Information
Processing Standards (FIPS Pub. 41 and FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 2300-537-1. Participant case files are
transferred to a Federal Records Center one year after closeout and
destroyed five years later. Closeout is the process by which it is
determined that all applicable administrative actions and loan
repayments have been completed by the LRP and service obligations have
been completed by the participant. Applicant case files are destroyed
three years after disapproval or withdrawal of their application.
Official appeal and litigation case files are destroyed six years after
the calendar year in which the case is closed. Other copies of these
files are destroyed two years after the calendar year in which the case
is closed.
Director, NIH Loan Repayment Program, Office of the Director,
National Institutes of Health, Federal Building, Room 102, 7550
Wisconsin Avenue, Bethesda, Maryland 20892-9015.
To determine if a record exists, write to the System Manager listed
above. The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be. The request should
include: (a) Full name, and (b) appropriate dates of participation. The
requester must also understand that the knowing and willful request for
acquisition of a record pertaining to an individual under false
pretenses is a criminal offense under the Act, subject to a five
thousand dollar fine. Requesters appearing in person must provide a
valid driver's license or passport, including photo, and at least one
other form of identification.
Write to the System Manager specified above to attain access to
records and provide the same information as is required under the
Notification Procedures. Requesters should also reasonably specify the
record contents being sought. Individuals may also request an
accounting of disclosure of their records, if any.
Contact the System Manager specified above and reasonably identify
the record, specify the information to be contested, the corrective
action sought, and your reasons for requesting the correction, along
with supporting information to show how the record is inaccurate,
incomplete, untimely or irrelevant. The right to contest records is
limited to information which is incomplete, irrelevant, incorrect, or
untimely (obsolete).
Subject individual; participating lending institutions; educational
institutions attended; other Federal agencies; consumer reporting
agencies/credit bureaus; and third parties that provide references
concerning the subject individual.
None.
Appendix I: System Locations
Loan Repayment Program, National Institutes of Health, Federal
Building, Room 102, 7550 Wisconsin Avenue, Bethesda, MD 20892-9015
Division of Computer Research and Technology, National Institutes of
Health, Building 12A, Room 4018, 9000 Rockville Pike, Bethesda, MD
20892
Operations Accounting Branch, Division of Financial Management,
National Institutes of Health, Building 31, Room B1B55, 9000
Rockville Pike, Bethesda, MD 20892
Division of Cancer Treatment, National Cancer Institute, National
Institutes of Health, Building 31, Room 3A44, 9000 Rockville Pike,
Bethesda, MD 20892
Division of Cancer Etiology, National Cancer Institute, National
Institutes of Health, Building 31, Room 11A11, 9000 Rockville Pike,
Bethesda, MD 20892
Division of Cancer Biology, Diagnosis, and Centers, National Cancer
Institute, National Institutes of Health, Building 31, Room 3A05,
9000 Rockville Pike, Bethesda, MD 20892
National Heart, Lung, and Blood Institute, National Institutes of
Health, Building 10, Room 7N220, 9000 Rockville Pike, Bethesda, MD
10892
National Institute of Dental Research, National Institutes of
Health, Building 31, Room 2C23, 9000 Rockville Pike, Bethesda, MD
20892
National Institute of Diabetes and Digestive and Kidney Diseases,
National Institutes of Health, Building 10, Room 9N222, 9000
Rockville Pike, Bethesda, MD 20892
National Institute of Neurological Disorders and Stroke, National
Institutes of Health, Building 10, Room 5N220, 9000 Rockville Pike,
Bethesda, MD 20892
National Institute of Allergy and Infectious Diseases, National
Instutes of Health, Building 31, Room 7A05, 9000 Rockville Pike,
Bethesda, MD 20892
Pharmacological Sciences Program, National Institute of General
Medical Sciences, National Institutes of Health, Building 45, Room
2AS, 9000 Rockville Pike, Bethesda, MD 20892
National Institute of Child Health and Human Development, National
Institutes of Health, Building 31, Room 2A25, 9000 Rockville Pike,
Bethesda, MD 20892
National Eye Institute, National Instutes of Health, Building 10,
Room 10N202, 9000 Rockville Pike, Bethesda, MD 20892
National Institute of Environmental Health Sciences, National
Institutes of Health, South Campus, Building 101, Room B-248, 111
Alexander Drive, Research Triangle Park, NC 27709 [[Page 4287]]
Gerontology Research Center, National Institute on Aging, National
Institutes of Health, 4940 Eastern Avenue, Baltimore, MD 21224
National Institute of Arthritis and Musculoskeletal and Skin
Diseases, National Institutes of Health, Building 31, Room 4C13,
9000 Rockville Pike, Bethesda, MD 20892
National Institute of Deafness and Communication Disorders, National
Institutes of Health, Building 31, Room 3C02, 9000 Rockville Pike,
Bethesda, MD 20892
National Institute for Nursing Research, National Institutes of
Health, Building 31, Room 5B06, 9000 Rockville Pike, Bethesda, MD
20892
National Center for Research Resources, National Institutes of
Health, Building 31, Room 3B36, 9000 Rockville Pike, Bethesda, MD
20892
Clinical Center, National Institutes of Health, Building 10, Room
1N312, 9000 Rockville Pike, Bethesda, MD 20892
National Institute on Alcohol Abuse and Alcoholism, National
Institutes of Health, Parklawn Building, Room 16C05, 5600 Fishers
Lane, Rockville, MD 20857
National Institute on Drug Abuse, National Institute of Health,
Parklawn Building, Room 10A38, 5600 Fishers Lane, Rockville, MD
20857
National Institute of Mental Health, National Institutes of Health,
Parklawn Building, Room 1599, 56 Fishers Lane, Rockville, MD 20857
Clinical Center Nursing Recruiting Office, National Institutes of
Health, Building 10, Room 2C206, 9000 Rockville Pike, Bethesda, MD
20892
09-25-0166
Administration: Radiation and Occupational Safety and Health
Management Information Systems, HHS/NIH/ORS.
None.
Radiation Safety Branch (RSB), Division of Safety, Office of Research
Services, NIH, Building 21, Room 134, 9000 Rockville Pike, Bethesda, MD
20892.
Occupational Safety and Health Branch (OSHB), Division of Safety,
National Institutes of Health, Building 13, Room 3K04, 9000 Rockville
Pike, Bethesda, Maryland 20892.
Write to appropriate System Manager at the address below for the
address of contractor locations, including the address of any Federal
Records Center where records from this system may be stored.
Radiation Safety Branch (RSB): NIH employees using radioactive
materials or radiation producing machinery, contractor employees who
provide service to the Radiation Safety Branch and any other
individuals who could potentially be exposed to radiation or
radioactivity as a result of NIH operations and who, therefore, must be
monitored in accordance with applicable regulations.
Occupational Safety and Health Branch (OSHB): Individuals
(including NIH employees and NIH service contract employees) who use or
come into contact with potentially hazardous biological or chemical
materials, and participants of occupational safety and health
monitoring/surveillance programs.
Employee name, title, organizational affiliation, birth date,
Social Security number (optional), work address, work telephone number,
name of supervisor, and other necessary employment information;
radiation/occupational safety and health training information; medical
and technical information pertaining to safety and health related
initiatives; research protocols and other related documents used to
monitor and track radiation exposure and exposure to potentially
hazardous biological or chemical materials; radiation materials usage
data; and incident data.
42 U.S.C. 241, regarding the general powers and duties of the
Public Health Service relating to research and investigation; 5 U.S.C.
7902 regarding agency safety programs; and 42 U.S.C. 2201, regarding
general duties of the Nuclear Regulatory Commission including the
setting of standards to cover the possession and use of nuclear
materials in order to protect health.
1. To provide adequate administrative controls to assure compliance
with internal NIH policies, and applicable regulations of the
Occupational Safety and Health Administration (OSHA), Department of
Labor, and other Federal and/or State agencies which may establish
health and safety requirements or standards. Ensure legal compliance
with requirements of Nuclear Regulatory Commission to maintain internal
and external radiation exposure data.
2. To identify, evaluate and monitor use or contact (including
incident follow-up) with:
a. Radiation (exposure maintained at lowest levels reasonable)
b. Biological and/or chemical (potentially hazardous materials).
3. To monitor, track, and assess the use of personal protective
equipment in the work place to ensure availability, effectiveness and
proper maintenance.
4. To address emergent safety and health issues or concerns.
1. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
2. Disclosure may be made to the Department of Justice or to a
court or other tribunal from this system of records, when (a) HHS, or
any component thereof; or (b) any HHS employee in his or her official
capacity; or (c) any HHS employee in his or her individual capacity
where the Department of Justice (or HHS, where it is authorized to do
so) has agreed to represent the employee; or (d) the United States of
any agency thereof where HHS determines that the litigation is likely
to affect HHS or any of its components, is a party to litigation or has
an interest in such litigation, and HHS determines that the use of such
records by the Department of Justice, court or other tribunal is
relevant and necessary to the litigation and would help in the
effective representation of the governmental party, provided, however,
that in each case HHS determines that such disclosure is compatible
with the purpose for which the records were collected.
3. Disclosure may be made to contractors for the purpose of
processing or refining the records. Contracted services may include
monitoring, testing, sampling, surveying, evaluating, transcription,
collation, computer input, and other records processing. The contractor
shall be required to maintain Privacy Act safeguards with respect to
such records.
4. Disclosure may be made to: (a) Officials of the United States
Nuclear Regulatory Commission which, by Federal regulation, licenses,
inspects and enforces the regulations governing the use of radioactive
materials; and (b) OSHA, which provides oversight to ensure that safe
and healthful work conditions are maintained for employees. Disclosure
will also be permitted to other Federal and/or State agencies which may
establish health and safety requirements or standards.
5. Radiation exposure and/or training and experience history may be
transferred to new employer.
6. A record may be disclosed for a research purpose, when the
Department: [[Page 4288]] (A) Has determined that the use or disclosure
does not violate legal or policy limitations under which the record was
provided, collected, or obtained; (B) has determined that the research
purpose (1) cannot be reasonably accomplished unless the record is
provided in individually identifiable form, and (2) warrants the risk
to the privacy of the individual that additional exposure of the record
might bring; (C) has required the recipient to (1) establish reasonable
administrative, technical, and physical safeguards to prevent
unauthorized use or disclosure of the record, (2) remove or destroy the
information that identifies the individual at the earliest time at
which removal or destruction can be accomplished consistent with the
purpose of the research project, unless the recipient has presented
adequate justification of a research or health nature for retaining
such information, and (3) make no further use or disclosure of the
record except (a) in emergency circumstances affecting the health or
safety of any individual, (b) for use in another research project,
under these same conditions, and with written authorization of the
Department, (c) for disclosure to a properly identified person for the
purpose of an audit related to the research project, if information
that would enable research subjects to be identified is removed or
destroyed at the earliest opportunity consistent with the purpose of
the audit, or (d) when required by law; (D) has secured a written
statement attesting to the recipient's understanding of, and
willingness to abide by these provisions.
Records are maintained in file cabinets or in computer databases
maintained by the RSB and OSHB. Records may be stored in file folders,
binders, magnetic tapes, magnetic disks, optical disks and/or other
types of data storage devices.
Records are retrieved by name, Social Security number, office
address, or unique RSB or OSHB assigned identification number.
1. Authorized users: Employees who maintain this system are
instructed to grant regular access only to RSB/OSHB staff, authorized
contractor personnel, U.S. Nuclear Regulatory Commission Inspectors,
Radiation Safety Committee Members, Biosafety Committee members, and
other appropriate NIH administrative and management personnel with a
need to know. Access to information is thus limited to those with a
need to know.
2. Physical safeguards: Rooms where records are stored are locked
when not in use. During regular business hours, rooms are unlocked but
are controlled by on-site personnel. Individually identifiable records
are kept in locked file cabinets or rooms under the direct control of
the Project Director.
3. Procedural safeguards: Names and other identifying particulars
are deleted when data from original records are encoded for analysis.
Data stored in computers is accessed through the use of keywords known
only to authorized users. All users of personal information in
connection with the performance of their jobs (see Authorized Users,
above) will protect information from public view and from unauthorized
personnel entering an unsupervised office. The computer terminals are
in secured areas and keywords needed to access data files will be
changed frequently.
4. Additional RSB technical safeguards: Computerized records are
accessible only through a series of code or keyword commands available
from and under direct control of the Project Director or his/her
delegated representatives. The computer records are secured by a
multiple level security system which is capable of controlling access
to the individual data field level. Persons having access to the
computer database can be restricted to a confined application which
only permits a narrow ``view'' of the data. Data on computer files is
accessed by keyword known only to authorized users who are NIH or
contractor employees involved in work for the program.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, supplementary Chapter PHS
hf: 45-13, the Department's Automated Information Systems Security
Program Handbook, and the National Institute of Standards and
Technology Federal Information Processing Standards (FIPS Pub. 41 and
FIPS Pub. 31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361): Item 1300-B which applies to Division of Safety
records. Refer to the NIH Manual Chapter for specific disposition
instructions. Radiation exposure records are retained under item 1300-
B-10, which does not allow disposal at this time.
Chief, Data and Analytical Services Section, Radiation Safety
Branch, DS, ORS, Building 21, Room 104, 9000 Rockville Pike, Bethesda,
Maryland 20892.
Chief, Occupational Safety and Health Branch, Division of Safety,
National Institutes of Health, Building 13, Room 3K04, 9000 Rockville
Pike, Bethesda, Maryland 20892.
To determine if a record exists, write to the appropriate system
manager as listed above.
The requestor must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requestor is whom he or she claims to be. The request should
include: (a) Full name, and (b) appropriate dates of participation.
Same as notification procedures. Requestors should also reasonably
specify the record contents being sought. Individuals may also request
an accounting of disclosure of their records, if any.
Contact the appropriate System Manager specified above and
reasonably identify the record, specify the information to be
contested, and state the corrective action sought with supporting
documentation. The right to contest records is limited to information
which is incomplete, irrelevant, incorrect, or untimely (obsolete).
Information is obtained from the subject individual, previous
employers and educational institutions, contractors, safety and health
monitoring/surveillance records, employee interviews, site visits, or
other relevant NIH organizational components.
None.
09-25-0168
Invention, patent and licensing documents submitted to the Public
Health Service by its employees, grantees, fellowship recipients and
contractors, HHS/PHS/NIH/OTT.
None. [[Page 4289]]
Office of Technology Transfer, National Institutes of Health, 6011
Executive Boulevard, Third Floor, Rockville, MD 20852.
Division of Financial Management (DFM), Operations Accounting
Branch, National Institutes of Health, Building 31, Room B1B55, 9000
Rockville Pike, Bethesda, Maryland 20892.
Division of Extramural Reports, Office of Extramural Research,
National Institutes of Health, Building 31, Room 5B41, 31 Center Drive,
Bethesda, Maryland 20892-2184.
Public Health Service (PHS) Technology Development Coordinators and
PHS Contract Attorneys retain files supplemental to the records
maintained by the Office of Technology Transfer. Write to the system
manager at the address below for office locations.
PHS employees, grantees, fellowship recipients and contractors who
have reported inventions, applied for patents, have been granted
patents, and/or are receiving royalties from patents.
Inventor name, address, Social Security number (required if
inventor is receiving royalties, otherwise optional), title and
description of the invention, Employee Invention Report (EIR) number,
prior art related to the invention, evaluation of the commercial
potential of the invention, prospective licensees' intended development
of the invention, associated patent prosecution and licensing documents
and royalty payment information.
45 CFR parts 6 (Inventions and Patents (General)), 7 (Employee
Inventions) and 8 (Inventions Resulting from Research Grants,
Fellowship Awards, and Contracts for Research), describing Departmental
standards for assessing, reporting, and maintaining rights, including
patent rights, in inventions of Departmental employees, grantees,
fellowship recipients, and contractors, or inventions made through
other resources and activities of the Department; Exec. Order No. 9865,
as amended, 35 U.S.C. 266 note, ``Patent protection abroad of
inventions resulting from research financed by the Government,''
describing the Government-wide policy for obtaining foreign patent
protection for inventions resulting from research conducted or financed
by the Government; and Exec. Order No. 10096, as amended, 35 U.S.C. 266
note, ``Uniform Government Patent Policy for Inventions by Government
Employees,'' describing Government-wide policy pertaining to inventions
made by Government employees.
Records in this system are used to: (1) Obtain patent protection of
inventions submitted by PHS employees; (2) monitor the development of
inventions made by grantees, fellowship recipients and contractors and
protect the government rights to patents made with NIH support; (3)
grant licenses to patents obtained through the invention reports; and
(4) provide royalty payments to PHS inventors.
1. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
2. Disclosure may be made to the Department of Justice or to a
court or other tribunal from this system of records, when (a) HHS, or
any component thereof; or (b) any HHS employee in his or her official
capacity; or (c) any HHS employee in his or her individual capacity
where the Department of Justice (or HHS, where it is authorized to do
so) has agreed to represent the employee; or (d) the United States or
any agency thereof where HHS determines that the litigation is likely
to affect HHS or any of its components, is a party to litigation or has
an interest in such litigation, and HHS determines that the use of such
records by the Department of Justice, court or other tribunal is
relevant and necessary to the litigation and would help in the
effective representation of the governmental party, provided, however,
that in each case HHS determines that such disclosure is compatible
with the purpose for which the records were collected. Disclosure may
also be made to the Department of Justice to obtain legal advice
concerning issues raised by the records in this system.
3. In the event that a system of records maintained by this agency
to carry out its functions indicates a violation or potential violation
of law, whether civil, criminal, or regulatory in nature, and whether
arising by general statute or particular program statute, or by
regulation, rule or order issued pursuant thereto, the relevant records
in the system of records may be referred to the appropriate agency,
whether Federal, State, or local, charged with enforcing or
implementing the statute or rule, regulation or order issued pursuant
thereto.
4. NIH may disclose records to Department contractors and
subcontractors for the purpose of collecting, compiling, aggregating,
analyzing, or refining records in the system. Contractors maintain, and
are also required to ensure that subcontractors maintain, Privacy Act
safeguards with respect to such records.
5. NIH may disclose information from this system of records for the
purpose of obtaining patent protection for PHS inventions and licenses
for these patents to: (a) Scientific personnel, both in this agency and
other Government agencies, and in non-Governmental organizations such
as universities, who possess the expertise to understand the invention
and evaluate its importance as a scientific advance; (b) contract
patent counsel and their employees and foreign contract personnel
retained by the Department for patent searching and prosecution in both
the United States and foreign patent offices; (c) all other Government
agencies whom PHS contacts regarding the possible use, interest in, or
ownership rights in PHS inventions; (d) prospective licensees or
technology finders who may further make the invention available to the
public through sale or use; (e) parties, such as supervisors of
inventors, whom PHS contacts to determine ownership rights, and those
parties contacting PHS to determine the Government's ownership; and (f)
the United States and foreign patent offices involved in the filing of
PHS patent applications.
6. NIH will report to the Treasury Department, Internal Revenue
Service (IRS), as taxable income, the amount of royalty payment paid to
PHS inventors.
The records will be stored in file folders, computer tapes and
computer discs.
Records are retrieved by name of the inventor, EIR number, or
keywords relating to the nature of the invention.
1. Authorized users: Data on computer files is accessed by keyword
known only to authorized users who are NIH or contractor employees
involved in patenting and licensing of PHS inventions. Access to
information is thus limited to those with a need to know.
2. Physical safeguards: records are stored in a locked room or in
locking [[Page 4290]] file cabinets in file folders. During normal
business hours, OTT Patent Branch and Licensing Branch on-site
personnel regulate availability of the files. During evening and
weekend hours the offices are locked and the building is closed.
3. Procedural and technical safeguards: Data stored in computers
will be accessed through the use of keywords known only to the
authorized users. A password is required to access the data base. All
users of personal information in connection with the performance of
their jobs (see Authorized Users, above) protect information, including
confidential business information submitted by potential licensees,
from public view and from unauthorized personnel entering an
unsupervised office.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
the Department's Automated Information System Security Program
Handbook, and the National Institute of Standards and Technology
Federal Information Processing Standards (FIPS Pub. 41 and FIPS Pub.
31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management manual,
Appendix B-361), item 1100-L, which allows records to be kept for a
maximum of twenty (20) years. Refer to the NIH Manual Chapter for
specific disposition instructions.
Chief, Technology Management Branch, Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Third Floor,
Rockville, Maryland 20852.
Division of Extramural Reports, Office of Extramural Research,
National Institutes of Health, Building 31, Room 5B41, 31 Center Drive,
Bethesda, MD 20892-2184.
To determine if a record exists, write to the System Manager listed
above. The requester must also verify his or her identity by providing
either a notarization of the request or a written certification that
the requester is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the
Act, subject to a five thousand dollar fine. The request should
include: (a) Full name, and (b) appropriate identifying information on
the nature of the invention.
Write to the System Manager specified above to attain access to
records and provide the same information as is required under the
Notification Procedures. Requesters should also reasonably specify the
record contents being sought. Individuals may also request an
accounting of disclosure of their records, if any.
Contact the System manager specified above and reasonably identify
the record, specify the information to be contested, the corrective
action sought, and your reasons for requesting the correction, along
with supporting information to show how the record is inaccurate,
incomplete, untimely or irrelevant. The right to contest records is
limited to information which is incomplete, irrelevant, incorrect, or
untimely (obsolete).
Inventors and other collaborating persons, grantees, fellowship
recipients and contractors; other Federal agencies; scientific experts
from non-Government organizations; contract patent counsel and their
employees and foreign contract personnel; Unites States and foreign
patent offices; prospective licensees; and third parties whom PHS
contacts to determine individual invention ownership or Government
ownership.
None.
09-25-0170
Diabetes Data System, HHS/NIH/NIDDK.
None.
A list of all contractor/subcontractor locations is available upon
request for the System Manager (see address below).
Individuals who participated in the Diabetes Prevention Trial--Type
1 Diabetes (DPT-1); the Diabetes Prevention Trial--Type 2 Diabetes
(DPT-2); the Epidemiology of Diabetes Interventions and Complications
Study (EDIC); the International Pancreas and Islet Transplant Registry
(IPITR), and family members of these participants.
Participant names, addresses, phone numbers; Social Security
numbers (voluntary), phone numbers, driver's license numbers, employer
information, spouse names, study identification numbers, educational
background, occupational history, names of medical provider, medical
record identification numbers, health and medical record data collected
during these trials and follow-up studies; the names, addresses and
phone numbers of acquaintances and relatives to assist in follow-up; a
family tree (or pedigree) and information pertaining to DCCT stored
biologic specimens (including blood, urine and genetic materials).
Section 301(a) of the Public Health Service (PHS) Act (42 U.S.C.
241(a)), describing the general powers and duties of the Public Health
Service relating to research and investigation, and section 426 of the
PHS Act (42 U.S.C. 285c) describing the purpose of the National
Institute of Diabetes and Digestive and Kidney Diseases to conduct
research with respect to, among other areas, diabetes mellitus.
These records are used to: (1) Conduct research on diabetes
mellitus in order to understand the disease and find better treatments
and/or an eventual cure; (2) conduct follow-up studies (projected
follow-up of 7-10 years) on the morbidity and mortality experiences of
study participants; and (3) provide relevant demographic, health and
medical record data on participants to biomedical researchers
authorized to use information and stored biologic materials.
1. Disclosure may be made to a congressional office from the record
of an individual in response to an inquiry from the congressional
office made at the request of that individual.
2. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
[[Page 4291]] affect directly the operations of the Department or any
of its components; or (c) any Department employee in his or her
individual capacity where the Department of Justice has agreed to
represent such employee, for example, in defending a claim against the
Public Health Service, based upon an individual's mental or physical
condition and alleged to have arisen because of activities of the
Public Health Service in connection with such individual, the
Department may disclose such records as it deems necessary to the
Department of Justice to enable that Department to present an effective
defense, provided that such disclosure is compatible with the purpose
for which the records were collected.
3. NIH may disclose records to Department contractors and
subcontractors for the purpose of collecting, compiling, aggregating,
analyzing, or refining records in the system. Contractors maintain, and
are also required to ensure that subcontractors maintain, Privacy Act
safeguards with respect to such records.
4. A record may be disclosed for a research purpose, when the
Department: (A) Has determined that the use or disclosure does not
violate legal or policy limitations under which the record was
provided, collected, or obtained; (B) has determined that the research
purpose (1) cannot be reasonably accomplished unless the record is
provided in individually identifiable form, and (2) warrants the risk
to the privacy of the individual that additional exposure of the record
might bring; (C) has required the recipient to (1) establish reasonable
administrative, technical, and physical safeguards to prevent
unauthorized use or disclosure of the record, (2) remove or destroy the
information that identifies the individual at the earliest time at
which removal or destruction can be accomplished consistent with the
purpose of the research project, unless the recipient has presented
adequate justification of a research or health nature for retaining
such information, and (3) make no further use or disclosure of the
record except (a) in emergency circumstances affecting the health or
safety of any individual, (b) for use in another research project,
under these same conditions, and with written authorization of the
Department, (c) for disclosure to a properly identified person for the
purpose of an audit related to the research project, if information
that would enable research subjects to be identified is removed or
destroyed at the earliest opportunity consistent with the purpose of
the audit, or (d) when required by law; (D) has secured a written
statement attesting to the recipient's understanding of, and
willingness to abide by these provisions.
5. Information from this system may be disclosed to Federal
agencies, State agencies (including the Motor Vehicle Administration
and State vital statistics offices, private agencies, and other third
parties (such as current or prior employers, acquaintances, relatives),
in order to obtain information on morbidity and mortality experiences
and to locate individuals for the follow-up studies. Social Security
numbers may be disclosed: (1) To the National Center for Health
Statistics to ascertain vital status through the National Death Index;
(2) to the Health Care Financing Agency to ascertain morbidities; and
(3) to the Social Security Administration to ascertain disabilities
and/or location of participants. Social Security numbers may also be
given to other Federal agencies, and State and local agencies for
purposes of locating individuals for participation in follow-up
studies.
Records may be stored in file folders and computer types and
diskettes, microfiche, and file cards.
Records are retrieved by name, Social Security number, or other
identifying numbers, keywords, and parameters of individual patient
health or medical record data.
1. Authorized users: Data on computer files is accessed by keyword
known only to authorized users who are NIH or contractor employees who
have a need for the data in performance of their duties as determined
by the system manager. Researchers authorized to conduct research on
biologic specimens will have access to the system through the use of
encrypted identifiers sufficient to link individuals with records in
such a manner that does not compromise confidentiality of the
individual. Access to information is thus limited to those with a need
to know.
2. Physical safeguards: Records and data tapes are stored in locked
files in secured areas with restricted access. During regular business
hours rooms are unlocked but are controlled by on-site personnel.
Terminal access is controlled by user ID and keywords; off-site data
backup is maintained in a separate building; fire protection is
maintained by an on-site fire extinguisher system and fire alarm system
present in the computer room.
3. Procedural and technical safeguards: Names and other identifying
particulars are deleted when data from original records are encoded for
analysis. Data stored in computers is accessed through the use of
keywords known only to authorized users. A password is required to
access the terminal and a data set name controls the release of data to
only authorized users. All users of personal information in connection
with the performance of their jobs (see Authorized Users, above)
protect information from public view and from unauthorized personnel
entering an unsupervised office. Contractors and subcontractors who
maintain records in this system are instructed to make no further
disclosure of the records except as authorized by the System manager
and permitted by the Privacy Act. Privacy Act requirements are
specifically included in contracts and in agreements with grantees or
collaborators participating in research activities supported by the
system. HHS project directors, contract officers, and project officers
oversee compliance with these requirements.
These practices are in compliance with the standards of Chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and the Department's Automated Information System Security Program
Handbook, and the National Institute of Standards and Technology
Federal Information Processing Standards (FIPS Pub. 41 and FIPS Pub.
31).
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1--``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 3000-G-3(b), which allows records to be kept as
long as they are useful in scientific research. Refer to the NIH Manual
Chapter for specific disposition instructions.
Chief, Diabetes Research Section, DPB, DDEM, National Institutes of
Diabetes and Digestive and Kidney Diseases, National Institutes of
Health, Westood Building, Room 622, 5333 Westbard Avenue, Bethesda, MD
20892.
To determine if a record exists, write to the System Manager listed
above. The [[Page 4292]] requester must also verify his or her identity
by providing either a notorization of the request or a written
certification that the requester is who he or she claims to be and
understands that the knowing and willful request for acquisition of a
record pertaining to an individual under false pretenses is a criminal
offense under the Act, subject to a five thousand dollar fine. The
request should include: (a) Full name, and (b) appropriate dates of
participation.
Individuals who request notification of or access to a medical
record shall, at the time the request is made, designate in writing a
responsible representative who will be willing to review the record and
inform the subject individual of its contents at the representative's
discretion.
A parent or guardian who requests notification of, or access to, a
child's/incompetent person's medical record shall designate a family
physician or other health professional (other than a family member) to
whom the record, if any, will be sent. The parent or guardian must
verify their relationship to the child/incompetent person as well as
his/her own identity.
Write to the System Manager specified above to attain access to
records and provide the same information as is required under the
Notification Procedures. Requesters should also reasonably specify the
record contents being sought. Individuals may also request an
accounting of disclosure of their records, if any.
Contact the System Manager specified above and reasonably identify
the record, specify the information to be contested, the corrective
action sought, and your reasons for requesting the correction, along
with supporting information to show how the record is inaccurate,
incomplete, untimely or irrelevant. The right to contest records is
limited to information which is incomplete, irrelevant, incorrect, or
untimely (obsolete).
Subject individual; patient health and medical record data; data
generated from the DCCT; Federal, State and local agencies (including
the Social Security Administration), and if the person is deceased,
from the National Death Index, and/or family members and other
knowledgeable third persons.
None.
09-25-0202
Patient Records on PHS Beneficiaries (1935-1974) and Civilly
Committed Drug Abusers (1967-1976) Treated at the PHS Hospitals in Fort
Worth, Texas, or Lexington, Kentucky, HHS/NIH/NIDA.
None.
National Institute on Drug Abuse, Intramural Research Program,
Johns Hopkins Bayview Medical Center, P.O. Box 5180, Baltimore,
Maryland 21224.
Federal Records Center, 1557 St. Joseph Avenue, East Point, Georgia
30344.
Washington National Records Center, 4205 Suitland Road, Washington,
DC 20409.
National Business Activities, 8200 Preston Court, Suite One,
Jessup, Maryland 20794.
Civilly committed narcotic addicts (1967-1976) and adult PHS
beneficiaries (1935-1974) treated at either the PHS hospital in Fort
Worth, Texas, or Lexington, Kentucky.
Administrative records, such as treatment admission and release
dates, name and address, and other demographic data; medical records,
such as, but not limited to, medical history information, drug abuse/
use data as well as treatment information, any laboratory tests, etc.
Narcotic Addict Rehabilitation Act of 1966, and Narcotic Addict
Rehabilitation Amendments of 1971, Titles I and III (42 U.S.C. 3411 et
seq. and 28 U.S.C. 2901 et seq.), and Public Health Service Act,
Sections 321-326, 341 (a) and (c) (42 U.S.C. 248-253, 257 (a) and (c).
The records were collected originally to monitor the individual's
progress while being treated at either of two PHS hospitals and to
ensure continuity of that care. These systems are now inactive. The
records are used to respond to requests from subject individuals (or
his/her designated representative) to (1) establish eligibility for
certain Federal benefits for the individual or his/her dependent(s),
and (2) provide information to subsequent health care providers at the
request of the individual regarding medical treatment received to
ensure continuity of care.
None.
Records at National Institute on Drug Abuse (NIDA) are on microfilm
and contain only part of the admission and discharge information. The
microfilm is stored in a file cabinet in a locked room. Records sent to
Federal Records Center are stored in GSA-approved storage containers.
The administrative records and microfilm are filed by patient name.
The medical records are filed either by patient name or by patient's
hospital number with a cross-reference list at NIDA matching number to
name.
1. Authorized users: Only the System Manager and designated staff.
2. Physical safeguards: The microfilm is in a room which has
limited access, or stored at a security coded warehouse. The room is
located in a building with a 24-hour security patrol/television
surveillance system. Sign in and out procedures are used at all times.
The warehouse has security access, records can only be retrieved by the
System Manager or designated staff using a confidential code number.
The warehouse is patrolled on a 24-hour basis with television
surveillance.
3. Procedural safeguards: Only the System Manager and his/her staff
have access to the microfilm information and have been trained in
accordance with the Privacy Act.
4. Implementation guidelines: DHHS Chapter 45-13 and supplementary
Chapter PHS.hf: 45-13 of the General Administration Manual.
All administrative and medical records have been retired to a
Federal Records Center. The records collected under the Narcotic Addict
Rehabilitation Act of 1966 will be destroyed when they are 25 years
old, which will be in 2001 because the last patient was released from
treatment in 1976. The PHS beneficiaries' records will be destroyed at
the same time. The [[Page 4293]] records will be shredded in 2003 upon
written request from the System Manager.
Medical Records Officer, National Institute on Drug Abuse,
Intramural Research Program, Johns Hopkins Bayview Medical Center, Box
5180, Baltimore, Maryland 21224.
To determine if a record exists, write to the System Manager at the
address above. An individual may learn if a record exists about himself
or herself upon written request with a notarized signature. The request
should include, if known: Patient hospital record number, full name or
any alias used, patient's address during treatment, birth date, veteran
status (if applicable) and approximate dates in treatment, and Social
Security Number.
An individual who requests notification of a medical record shall,
at the time the request is made, designate in writing a responsible
representative who will be willing to review the record and inform the
individual of its content at the representative's discretion.
Same as Notification Procedures. Requesters should also reasonably
specify the record contents being sought. An individual may also
request an accounting of disclosures of his/her record, if any.
Contact the official at the address specified under Notification
Procedures above, and reasonably identify the record, specify the
information being contested, and state the corrective action sought,
with supporting information to show how the record is inaccurate,
incomplete, untimely, or irrelevant.
Patients; patients' drug treatment program counselors; court
records; hospital personnel.
None.
09-25-0203
National Institute on Drug Abuse, Intramural Research Program,
Federal Prisoner and Non-Prisoner Research Files, HHS/NIH/NIDA.
None.
National Institute on Drug Abuse, Intramural Research Program, P.O.
Box 5180, Baltimore, Maryland 21224.
Maryland Medical Laboratories, Inc., Pathology Building, 1901
Silver Spring Road, Baltimore, Maryland 21227.
Federal Records Center, 1557 St. Joseph Avenue, East Point, Georgia
30344.
Washington National Records Center, 4205 Suitland Road, Washington,
DC 20409.
NOVA, Johns Hopkins Bayview Medical Center, Building C, 4940
Eastern Avenue, Baltimore, Maryland 21224.
National Business Activities, 8200 Preston Court, Suite One,
Jessup, Maryland 20794.
Volunteers, adult males (from 1968 to present), adult females
(beginning in 1985) and adolescents (ages 13-18, beginning in 1983) and
children (neonate to 12 beginning in 1989). Clinical research projects
conducted at the Addiction Research Center (ARC). This system also
includes records on adult Federal prisoners involved in research
projects at ARC when located at Lexington, Kentucky, from 1968-1976,
and some records from system 09-30-0020 to be used for statistical
research only.
The categories of records involved are administrative, medical and
research records.
Public Health Service Act, section 301(a) (42 U.S.C. 241(a));
sections 341(a) and 344(d) (42 U.S.C. 257(a) and 260(d)); section 503
and 515 (42 U.S.C. 290aa-2 and 290cc). These sections authorize the
conduct of research in all areas of drug abuse.
(1) To collect and maintain a data base for research activities at
ARC, and (2) to enable Federal drug abuse researchers to evaluate and
monitor the subjects' health during participation in a research
project. The areas of research include, but are not limited to,
biomedical, clinical, behavioral, pharmacological, psychiatric,
psychosocial, epidemiological, etiological, statistical, treatment and
prevention of narcotic addiction and drug abuse.
1. The National Institute on Drug Abuse (NIDA) uses a contractor to
recruit volunteers and to screen these individuals for their
acceptability to participate in specific research projects, and limits
the contractor's access to the records to these procedures. NIDA also
uses a contractor to perform routine medical laboratory tests on blood
and urine samples. These routine tests verify that the subject is in
good health. Both contractors disclose records from this system only to
NIDA and are required to maintain Privacy Act safeguards with respect
to such records.
2. (a) PHS may inform the sexual and/or needle-sharing partner(s)
of a subject individual who is infected with the human immunodeficiency
virus (HIV) of their exposure to HIV, under the following
circumstances: (1) The information has been obtained in the course of
clinical activities at PHS facilities carried out by PHS personnel or
contractors; (2) The PHS employee or contractor has made reasonable
efforts to counsel and encourage the subject individual to provide the
information to the individual's sexual or needle-sharing partner(s);
(3) The PHS employee or contractor determines that the subject
individual is unlikely to provide the information to the sexual or
needle-sharing partner(s) or that the provision of such information
cannot reasonably be verified; and (4) The notification of the
partner(s) is made, whenever possible, by the subject individual's
physician or by a professional counselor and shall follow standard
counseling practices.
(b) PHS may disclose information to State or local public health
departments, to assist in the notification of the subject individual's
sexual and/or needle-sharing partner(s), or in the verification that
the subject individual has, notified such sexual or needle-sharing
partner(s).
Data may be stored in file folders or on computer disks, magnetic
tapes, or microfilm.
Administrative and medical records are indexed and retrieved by the
subject's name and identification code number. Research records are
indexed and retrieved by the subject's name and identification code
number. [[Page 4294]]
1. Authorized areas: Only authorized ARC staff (Principal
Investigator and his/her research team) are allowed access to these
files. The contractor staff has access to the files during the
recruitment/screening process.
2. Physical safeguards: Files and file rooms are locked after
business hours. Building has electronic controlled entry at all times
with a 24-hour guard/television surveillance system. The computer
terminals are in a further secured area.
3. Procedural safeguards: All users of personal information in
connection with the performance of their jobs protect information from
unauthorized personnel. Access codes to the research records are
available only to the Principal Investigator and his/her research team.
Access to the records is strictly limited to those staff members
trained in accordance with the Privacy Act. The contractor staff
members are required to secure the information in accordance with the
Privacy Act. ARC Project Officer and contracting officials will monitor
contractor compliance.
4. Implementation guidelines: DHHS Chapter 45-13 and supplementary
Chapter PHS.hf: 45-13 of the General Administration Manual; and Chapter
6-05, ``Risk Management,'' under Part 6 in the Department's ADP Systems
Security Manual.
In addition, because much of the data collected in these research
projects are sensitive and confidential, special safeguards have been
established. Certificates of confidentiality have been issued under
Protection of Identity--Research Subjects Regulations (42 CFR part 2a)
to those projects initiated since February 1980. This authorization
enables persons engaged in research on mental health, including
research on the use and effect of psychoactive drugs, to protect the
privacy of research subjects by withholding their names or other
identifying characteristics from all persons not connected with the
conduct of the research. Persons so authorized may not be compelled in
any Federal, State, or local civil, criminal, administrative,
legislative, or other proceeding to identify such individuals. In
addition, these records are subject to 42 CFR part 2, the
Confidentiality of Alcohol and Drug Abuse Patient Records Regulations
(42 CFR 2.56), which state: ``Where the content of patient records has
been disclosed pursuant to these regulations for the purpose of
conducting scientific research * * * information contained therein
which would directly or indirectly identify any patient may not be
disclosed by the recipient thereof either voluntarily or in response to
any legal process whether Federal or State.''
Records will be disposed of in accordance with the NIH Records
Control Schedule, i.e., when the records are 10 years old or no longer
required for administrative or research purposes. The records on
individuals who do not qualify for a specific research project are kept
for one year by the contractor who then destroys them by shredding.
Medical Records Officer, NIDA, Intramural Research Program, Johns
Hopkins Bayview Medical Center--Building C, P.O. Box 5180, Baltimore,
Maryland 21224.
To determine if a record exists, write to the System Manager at the
address above. Provide a notarized signature as proof of identify. This
can be waived if the request is made through official federal, state,
or local channels. The request should include the patient's register
number and/or the number of years of incarceration (for prisoner
subjects), full name at time of participation in the research project,
date(s) of research participation, and title of research project or
name of drug being studied. An individual who requests notification of
a medical record shall, at the time the request is made, designate in
writing a responsible representative who will be willing to review the
record and inform the subject individual of its contents at the
representative's discretion.
A parent or legal guardian who requests notification of an
adolescent's record shall designate a family physician or other health
professional (other than a family member) of the Addiction Research
Center staff to whom the record, if any, will be sent. The parent or
legal guardian must verify in writing the relationship to the
adolescent as well as his/her own identity.
Same as Notification Procedures. Requesters should also reasonably
specify the record contents being sought. An individual may also
request an accounting of disclosures that have been made of his/her
records, if any.
Contact the official at the address specified under Notification
Procedures above and reasonably identify the record, specify the
information being contested, and state the corrective action sought and
reasons for requesting the correction, along with supporting
information to show how the record is inaccurate, incomplete, untimely,
or irrelevant.
The individual; observations and medical recordings (such as blood
pressure, dosage of compound administered, etc.) made by the Principal
Investigator and his/her research team; system of records number 09-30-
0020; drug treatment programs; Bureau of Prisons; case workers;
psychiatrists; research laboratories; and pharmacies and hospitals.
Many of these records are confidential and privileged communication is
guaranteed under section 344(d) of the PHS Act.
None.
09-25-0205
Alcohol, Drug Abuse, and Mental Health Epidemiologic and Biometric
Research Data, HHS/NIH/NIAAA, HHS/NIH/NIDA and HHS/NIH/NIMH.
None.
Records are located at the research facilities which collect or
provide research data for this system under contract to the agency.
Contractors may include, but are not limited to, research centers,
clinics, hospitals, universities, research foundations, national
associations, and coordinating centers. Records may also be located at
the research facilities of the National Institute on Alcohol Abuse and
Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA); and
the National Institute of Mental Health (NIMH). A current list of sites
is available by writing to the appropriate System Manager at the
address below.
Individuals who are the subjects of research in epidemiologic,
clinical, methodologic, and longitudinal research studies and surveys
of mental health and alcohol and drug use/abuse and mental, alcohol,
and/or drug abuse disorders. These individuals are selected as
representative of the general adult and/or child population or of
special groups. Special groups include, but are not limited to, normal
individuals serving as controls; clients referred for or receiving
medical, mental [[Page 4295]] health, and alcohol and/or drug abuse
related treatment and prevention services; providers of services;
demographic sub-groups as applicable, such as age, sex, ethnicity,
race, occupation, geographic location; and groups exposed to
hypothesized risks, such as relatives of individuals who have
experienced mental health and/or alcohol, and/or drug abuse disorders,
life stresses, or have previous history of mental, alcohol, and/or drug
abuse related illness.
The system contains data about the individual as relevant to a
particular research study. Examples include, but are not limited to,
items about the health/mental health and/or alcohol or drug consumption
patterns of the individual; demographic data; social security numbers
(voluntary); past and present life experiences; personality
characteristics; social functioning; utilization of health/mental
health, alcohol, and/or drug abuse services; family history;
physiological measures; and characteristics and activities of health/
mental health; alcohol abuse, and/or drug abuse care providers.
Public Health Service Act, sections 301 and 405 (42 U.S.C. 241, and
284, General Research and Investigation Authorities); Public Health
Service Act, sections 301, 302, 303 and Title V, Parts A and B (42
US.C. 241, 242, 242(a).
The purpose of the system of records is to collect and maintain
databases for research activities. Analyses of these data involve
groups of individuals with given characteristics and do not refer to
special individuals. The generation of information and statistical
analyses will ultimately lead to a better description and understanding
of mental, alcohol, and/or drug abuse disorders, their diagnosis,
treatment and prevention, and the promotion of good physical and mental
health.
1. A record may be disclosed for a research purpose, when the
Department: (a) As determined that the use or disclosure does not
violate legal or policy limitations under which the record was
provided, collected, or obtained; e.g., disclosure of alcohol or drug
abuse patient records will be made only in accordance with the
restrictions of confidentiality statutes and regulations 42 U.S.C. 290
(dd-3), 42 U.S.C. 241 and 405, 42 CFR part 2, and where applicable, no
disclosures will be made inconsistent with an authorization of
confidentiality under 42 U.S.C. 242a and 42 CFR part 2a; (b) as
determined that the research purpose (1) cannot be reasonably
accomplished unless the record is provided in individually identifiable
form, and (2) warrants the risk to the privacy of the individual that
additional exposure of the record might bring; (c) has required the
recipient to--(1) establish reasonable administrative, technical, and
physical safeguards to prevent unauthorized use or disclosure of the
record, and (2) remove or destroy the information that identifies the
individual at the earliest time at which removal or destruction can be
accomplished consistent with the purpose of the research project,
unless the recipient has presented adequate justification of a research
or health nature for retaining such information, and (3) make no
further use or disclosure of the record except--(A) in emergency
circumstances affecting the health or safety of any individual, (B) for
use in another research project, under these same conditions, and with
written authorization of the Department, (C) for disclosure to a
properly identified person for the purpose of an audit related to the
research project, if information that would enable research subjects to
be identified is removed or destroyed at the earliest opportunity
consistent with the purpose of the audit, or (D) when required by law;
and (d) has secured a written statement attesting to the recipient's
understanding of, and willingness to abide by, these provisions.
2. Disclosure may be made to a congressional office from the record
of an individual in response to a verified inquiry from a congressional
office made at the written request of that individual.
3. In the event of litigation, where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department is his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operations of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee; the Department may disclose such records as it deems
desirable or necessary to the Department of Justice to enable that
Department to present an effective defense, provided such disclosure is
compatible with the purpose for which the records were collected (e.g.,
disclosure may be made to the Department of Justice or other
appropriate Federal agencies in defending claims against the United
States when the claim is based upon an individual's mental or physical
condition and is alleged to have arisen because of the individual's
participation in activities of a Federal Government supported research
project).
4. The Department contemplates that it will contract with a private
firm for the purpose of collecting, analyzing, aggregating, or
otherwise refining records in this system. Relevant records will be
disclosed to such contractor. The contractor shall be required to
maintain Privacy Act safeguards with respect to such records.
Records may be stored on index cards, file folders, computer tapes
and disks, microfiche, microfilm, and audio and video tapes. Normally,
the factual data, with study code numbers, are stored on computer tape
or disk, while the key to personal identifiers is stored separately,
without factual data, in paper files.
During data collection stages and followup, if any, retrieval by
personal identifier (e.g., name, social security number) (in some
studies), or medical record number), is necessary. During the data
analysis stage, data are normally retrieved by the variables of
interest (e.g., diagnosis, age, occupation).
1. Authorized users: Access to identifiers and to link files is
strictly limited to the authorized personnel whose duties require such
access. Procedures for determining authorized access to identified data
are established as appropriate for each location. Personnel, including
contractor personnel, who may be so authorized include those directly
involved in data collection and in the design of research studies,
e.g., interviewers and interviewer supervisors; project managers;
statisticians involved in designing sampling plans.
2. Physical safeguards: Records are stored in locked rooms, locked
file cabinets, and/or secured computer facilities. Personal identifiers
and link files are separated as much as possible and stored in locked
files. Computer data access is limited through the use of key words
known only to authorized personnel.
3. Procedural safeguards: Collection and maintenance of data is
consistent [[Page 4296]] with legislation and regulations in the
protection of human subjects, informed consent, confidentiality, and
confidentiality specific to drug and alcohol abuse patients where these
apply. When an Institute Division or a contractor provides anonymous
data to research scientists for analysis, study numbers which can be
matched to personal identifiers will be eliminated, scrambled, or
replaced by the agency or contractor with random numbers which cannot
be matched. Contractors who maintain records in this system are
instructed to make no further disclosure of the records. Privacy Act
requirements are specifically included in contracts for survey and
research activities related to this system. The HHS project directors,
contract officers, and project officers oversee compliance with these
requirements.
4. Implementation guidelines: DHHS Chapter 45- and supplementary
Chapter PHS.hf: 45-13 of the General Administration Manual and Part 6,
``ADP System Security'' of the HHS ADP Systems Security Manual.
Personal identifiers are retained only as long as they are needed
for the purposes of the current research project, and for followup
studies generated by the present study. Removal or disposal of
identifiers is done according to the storage medium (e.g., erase
computer tape, shred or burn index cards, etc.). A staff person
designated by the System Manager will oversee and will describe and
confirm the disposal in writing.
Privacy Act Coordinator, National Institute of Mental Health, Room
7C-22, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857.
Deputy Director, Division of Biometry and Epidemiology, National
Institute on Alcohol Abuse and Alcoholism, Willco Building, Suite 514,
6000 Executive Blvd. MSC 7003, Bethesda, MD 20892-7003.
Deputy Director, Division of Clinical and Prevention Research,
National Institute on Alcohol Abuse and Alcoholism, Willco Building,
Suite 505, 6000 Executive Blvd. MSC 7003, Bethesda, MD 20892-7003.
Privacy Act Coordinator, National Institute on Drug Abuse, Room
10A-42, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland
20857.
To determine if a record exists, write to the appropriate System
Manager at the address above. Provide individual's name; current
address; date of birth; date, place and nature of participation in
specific research study; name of individual or organization
administering the research study (if known); name or description of the
research study (if known); address at the time of participation; and a
notarized statement by two witnesses attesting to the individual's
identity.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. An individual may also
request an accounting of disclosures of his/her record, if any.
An individual who requests notification of, or access to, a medical
record shall, at the time the request is made, designate in writing a
responsible representative who will be willing to review the record and
inform the subject individual of its contents at the representative's
discretion.
A parent or guardian who requests notification of, or access to, a
child's or incompetent person's medical record shall designate a family
physician or other health professional (other than a family member) to
whom the record, if any, will be sent. The parent or guardian must
verify relationship to the child or incompetent person as well as his
or her own identity.
Contact the appropriate official at the address specified under
System Manager(s) above and reasonably identify the record, specify the
information being contested, and state corrective action sought, with
supporting information to show how the record is inaccurate,
incomplete, untimely, or irrelevant.
The system contains information obtained directly from the subject
individual by interview (face-to-face or telephone), by written
questionnaire, or by other tests, recording devices or observations,
consistent with legislation and regulation regarding informed consent
and protection of human subjects. Information is also obtained from
other sources, such as health, mental health, alcohol, and/or drug
abuse care providers; relatives; guardians; and clinical medical
research records.
None.
09-25-0207
Subject-Participants in Pharmacokinetic Studies on Drugs of Abuse
and on Treatment Medications, HHS/NIH/NIDA.
None.
University of California, San Francisco, Langley Porter Psychiatric
Institute, San Francisco, California 94143.
Normal, healthy adults who voluntarily participate in studies on
the pharmacokinetics and pharmacodynamics of psychoactive drugs at
Langley Porter Psychiatric Institute, during the period September 1987
through June, 1997.
Research records on each subject-participant contain the following
information: Name; clinician's records including medical history,
laboratory test results, physical examinations, psychological profile,
and drug use profile; drug study data including records of drugs
administered, exposures to radioactivity, and drug reactions; and date
of study in which the subject participated.
Public Health Service Act, sections 301(a), 503 and 405 (42 U.S.C.
241 and 284).
The primary purpose of this system is to support research on the
pharmacokinetics and pharmacodynamics of drugs of abuse as well as
treatment drugs. The term ``pharmacokinetics'' refers to the manner in
which the human body processes a drug. ``Pharmacodynamics'' refers to
the manner in which the drug affects the human body.
The clinical investigator used data of a medical nature that is
contained in the system to make determinations regarding drug dosages
and/or radiochemical exposures appropriate to the individual human
subject-participants, in order to preserve and protect the health of
each. The system also provides baseline data for studying the drug
effects.
The Food and Drug Administration (FDA) also may use the records in
routine inspections FDA conducts in accordance with its
responsibilities to [[Page 4297]] develop standards on the composition,
quality, safety, and efficacy of drugs administered to humans, and to
monitor experimental usage of drugs.
1. We may disclose to a congressional office the record of an
individual in response to a verified inquiry from the congressional
office made at the written request of the individual.
2. NIH contractors, use the records in this system to accomplish
the research purpose for which the records are collected. The
contractors are required to maintain Privacy Act safeguards with
respect to such records.
The contractor maintains the records on paper in file folders.
The contractor indexes and retrieves the records by the subject-
participant's name.
1. Authorized users: Only the contract Project Director and his/her
research team and the Federal Project Officer and his/her support staff
have access to these records.
2. Physical safeguards: The contractor keeps all records in a
locked metal file cabinet in premises with limited accessibility. Only
the clinical investigator (Project Director) has the key to the locked
files.
3. Procedural safeguards: Only the contract staff have access to
the files. Persons other than subject participants who request
individually identifiable data from a record, must provide written
consent from the subject participant permitting the requested
disclosure. The only exception would be for disclosure to persons or
organizations permitted by the Privacy Act, Section 3(B) to obtain
personally identifiable data.
4. Implementation guidelines: DHHS Chapter 45-13 and supplementary
Chapter PHS.hf: 45-13 of the General Administration Manual. In
addition, the contract staff complies with contractor's (University of
California, San Francisco) standard procedures for safeguarding data.
The records will be kept no later than June 2002 (5 years after the
anticipated completion of the studies). At that time, the NIDA project
officer will authorize in writing the clinical investigators to destroy
the records by shredding or burning.
Project Officer, Pharmacokinetic Studies on Drugs of Abuse,
Medications Development Division, National Institute on Drug Abuse,
National Institutes of Health, Room 11A55, Parklawn Building, 5600
Fishers Lane, Rockville, Maryland 20857.
To determine if a record exists, write to the system manager listed
above.
Provide the following information: Subject-participant's full name
and a letter of request (or permission, if the requester is not the
subject-participant) with notarized signature of the individual who is
the subject of the record, approximate date(s) of experiment(s) in
which the individual participated, and drug name (if known). In
addition, an individual who requests notification of, or access to, a
medical record shall, at the time the request is made, designate in
writing a responsible representative who will be willing to review the
record and inform the subject individual of its content at the
representative's discretion.
Same as Notification Procedures. Requesters should also reasonably
specify the record contents being sought. An individual may also
request an accounting of disclosures of his/her record, if any.
Contact the System Manager at the address above and reasonably
identify the record, specify the information to be contested, the
corrective action sought, with supporting information to show how the
record is inaccurate, incomplete, untimely, or irrelevant.
The subject-participants and the contractor personnel conducting
the research studies.
None.
09-25-0208
Drug Abuse Treatment Outcome Study (DATOS), HHS/NIH/NIDA.
None.
Research Triangle Institute, Center for Social Research and Policy
Analysis, Research Triangle Park, North Carolina 27709.
Voluntary adult clients of federally funded treatment programs,
including Treatment Alternative Street Crime (TASC) Programs of the
Department of Justice, who requested to be included in TOPS from 1979
through 1986. New data collected from voluntary adults/adolescent
clients of public and private funded-treatment programs beginning in
1991 and will continue through 1995.
The categories are: Demographic data, treatment outcome data,
treatment process data, client locator information, and personal
identifiers (name and assigned numerical identifier).
Public Health Service Act, sections 301 and 405 (42 U.S.C. 241 and
284.
The purpose of the system is to compile information on drug abusers
in drug abuse treatment programs in order to derive information on the
treatment environments and abusers' behaviors and characteristics
subsequent to treatment. Researchers and drug abuse service providers
may use the aggregate data to address issues and generate hypotheses to
understand better the interactions among the client and community.
1. Within the restrictions set forth in HHS regulations concerning
the confidentiality of drug abuse patient records (42 CFR 2.56), we may
disclose a record for a research purpose, when the Department: (a) Has
determined that the use or disclosure does not violate legal or policy
limitations under which the record was provided, collected, or
obtained; (b) has determined that the research purpose (1) cannot be
reasonably accomplished unless the record is provided in individually
identifiable form, and (2) warrants the risk to the privacy of the
individual that additional exposure of the record might bring, (c) has
required the recipient to (1) establish reasonable administrative,
technical, and physical safeguards to prevent unauthorized use or
disclosure of the record, (2) remove or destroy the information that
identifies the individual at the earliest time at which removal or
destruction can be accomplished consistent with the purpose of the
research project, unless [[Page 4298]] the recipient has presented
adequate justification of a research or health nature for retaining
such information, and (3) make no further use or disclosure of the
record except: (A) In emergency circumstances affecting the health or
safety of any individual, (B) for use in another research project,
under these same conditions, and with written authorization of the
Department, (C) for disclosure to a properly identified person for the
purpose of an audit related to the research project, if information
that would enable research subjects to be identified is removed or
destroyed at the earliest opportunity consistent with the purpose of
the audit, or (D) when required by law; (d) has secured a written
statement attesting to the recipient's understanding of, and
willingness to, abide by these provisions.
2. The Research Triangle Institute, an NIH contractor, uses the
records in this system to accomplish the research purpose for which the
records are collected. In the event of followup studies or continuation
studies because the contract has been terminated for convenience by the
Government, we may disclose records in this system to a subsequent NIH
contractor. We would require the new contractor to maintain Privacy Act
safeguards with respect to such records.
Interview forms, magnetic tapes, and disks.
Records are indexed and retrieved by unique alpha numerical
identifier. In order to relate the data collected to specific
individuals, one must use the link file discussed under Safeguards.
1. Authorized users: Contractor personnel, the agency project
officer, and agency employees whose duties require the use of the
information in the system.
2. Physical safeguards: The data management task leader, the
project leader, or the project director provide technical supervision
of all data collection and processing activities. Individually
identified forms are stored in a secure, vault-like room provided for
this purpose. Authorized personnel have access to the room by one
locked door with controlled entry, i.e., only on the written authority
of the professional staff member in charge. Computerized records are
kept in a vault area with limited accession.
3. Procedural safeguards: Because some of the data collected in
this study, such as data on drug use, are sensitive and confidential,
special safeguards have been established. A Certificate of
Confidentiality has been issued under 42 CFR part 2a. This
authorization enables persons engaged in research on mental health,
including research on the use and effect of psychoactive drugs, to
protect the privacy of research subjects by withholding the names or
other identifying characteristics from all persons not connected with
the conduct of the research. Persons so authorized may not be compelled
in any Federal, State, or local civil, criminal, administrative,
legislative, or other proceedings, to identify such individuals. In
addition, these records are subject to 42 CFR part 2, the
Confidentiality of Alcohol and Drug Abuse Patient Records Regulations
(42 CFR 2.56), which state: ``Where the content of patient records has
been disclosed pursuant to (these regulations) for the purpose of
conducting scientific research * * * information contained therein
which would directly or indirectly identify any patient may not be
disclosed by the recipient thereof either voluntarily or in response to
any legal process whether Federal or State.''
Another safeguard is that the forms containing subject
identification information for client followup and data matching
purposes do not include any reference to the purpose of the study.
Identification and location information is kept separate from any
information that would suggest that the respondent has been in a drug
treatment program.
Information on completed forms is entered immediately on the
computer. Completed forms and computerized data are released only to
authorized persons. Only aggregate data are provided and used in the
preparation of necessary and appropriate reports.
A link file system is used. This system has three components: (1)
Personal information, (2) data base information, and (3) the link file,
which contains identifying number pairs which can be used to match data
with individuals. The advantage of this system is that the data base
can be used directly for report generation, etc., without the use of
decrypting subroutines or access to the personal information or
matching link files.
In addition, the computer center being utilized has developed an
extensive security system to protect computer account codes and data.
This system is described in a publication that is available from the
System Manager upon request.
We do not anticipate any disclosure of individually identifiable
information to other persons or organizations within the Department of
Health and Human Services. Nor does the contractor provide individually
identification information to the Department of Justice, with which
NIDA has a cooperative agreement for this study.
4. Implementation guidelines: We used the National Bureau of
Standards guidelines and Part 6, HHS ADP Systems Security Manual, ``ADP
System Security'' in developing the computer safeguard procedures.
Safeguards for nonautomated records are in accordance with DHHS Chapter
45-13 and supplementary Chapter PHS.hf: 45-13 of the General
Administration Manual. In addition, project staff complies with the
contractor's (Research Triangle Institute) standard procedures for
safeguarding data.
The contractor provides only aggregate information to NIDA.
The contractor destroys interview forms by shredding or burning
immediately after contractor staff have completed and verified direct
entry on magnetic tape or disk storage. The contractor will destroy
individual identification and location data by shredding or burning,
under the explicit written authorization of the System Manager, which
is anticipated to be no longer than 5 years after the termination of
the study unless the information is needed for research purposes. We
will retain aggregate data tapes for research purposes. These tapes
will not have any individually identifiable information. In accordance
with the NIH Records Control Schedule, these tapes will be retained for
5 years after completion of the project (approximately 2000). At that
time, the tapes will be retired to the Federal Records Center and
destroyed when they are 10 years old or when they are no longer needed
for research purposes.
Drug Abuse Treatment Outcome Study (DATOS), Project Officer,
Services Research Branch, Division of Clinical and Services Research,
National Institute on Drug Abuse, National Institutes of Health, Room
10A-30, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland
20857.
To determine if a record exists, write to the System Manager at the
address above. An individual may learn if a [[Page 4299]] record exists
about himself/herself upon written request, with notarized signature.
The request should include, if known, name of the researcher, location
of the research site, approximate date of data collection, any alias
used, and subject identification number.
An individual who requests notification of a medical record shall,
at the time the request is made, designate in writing a responsible
representative who will be willing to review the record and inform the
subject individual of its contents at the representative's discretion.
A parent or legal guardian who requests notification of an
adolescent's record shall designate a family physician or other health
professional (other than a family member) of the Division of Clinical
Research staff to whom the record, if any, will be sent. The parent or
legal guardian must verify in writing the relationship to the
adolescent as well as his/her own identity.
Same as Notification Procedures. Requesters should also reasonably
specify the record contents being sought. An individual may also
request an accounting of disclosures of his/her record, if any.
Persons other than subject individuals, who request individually
identifiable data from a record must provide written consent from the
subject individual permitting the requested disclosure. The only
exception (if not in conflict with confidentiality regulations) would
be for disclosure to persons or organizations permitted by the Privacy
Act, section 3(b), to obtain personally identifiable data.
Contact the official at the address specified under Notification
Procedures above and reasonably identify the record, specify the
information being contested, the corrective action sought, with
supporting information to show how the record is inaccurate,
incomplete, untimely, or irrelevant.
Research subjects, and staff in participating drug abuse treatment
programs, written clinical evaluations, counselors, psychiatrists,
psychotherapists, family members, research assistants, hospitals.
None.
09-25-0209
Subject-Participants in Drug Abuse Research Studies on Drug
Dependence and in Research Supporting New Drug Applications, HHS/NIH/
NIDA.
None.
Veterans Administration Hospital, Cooperative Studies Program,
Department of Veterans Medical Center, Perry Point, MD 21902.
Dixon and Williams Pharmaceutical, 5775 Hyde Park Circle,
Jacksonville, Florida 32210.
Medications Development Division, Room 11A-55, and Division of
Clinical Research, Room 10A-38, Parklawn Building, National Institute
on Drug Abuse, 5600 Fishers Lane, Rockville, MD 20857.
Veterans Affairs Medical Center, 50 Irving Street, NW., Washington,
DC 20422.
Veterans Affairs Medical Center, University and Woodland Avenues,
Philadelphia, PA 19104.
Veterans Affairs Medical Center, Brentwood Division, Wilshire and
Sawtell Boulevards, Los Angeles, CA 90073.
National Institute on Drug Abuse, Division of Intramural Research
Programs, 4940 Eastern Avenue, Baltimore, MD 21224.
Write to the system manager at the address below for the address of
any new locations where records from this system may be stored.
Voluntary adult clients of federally funded and other drug abuse
treatment programs who have requested to receive investigational new or
marketed drugs, such as but not limited to, naltrexone, levo-alpha
acetylmethadol (LAAM), or Buprenorphine as part of their treatment.
Data collection for the earlier LAAM studies began in 1975 and
continued through September 1979; additional LAAM studies began in 1992
and will continue through September 1997, naltrexone studies began in
1977 and continued through June 1984; and studies for other
investigational new compounds (buprenorphine, gepirone, etc.) began in
1992 and may continue through September 1997.
Demographic data, treatment outcome data, treatment process data,
client locator information, and personal identifiers (name and assigned
numerical identifier).
Public Health Service Act, sections 301, 464p, and 405 (42 U.S.C.
241, and 284).
1. To maintain information on the safety and effectiveness of drugs
for treatment of drug dependence with or without abuse potential in
various treatment environments and modalities and changes in the
behavior and characteristics of drug abusers who received these
substances as part of their treatment regimen.
2. To provide data required by the Food and Drug Administration
(FDA) to support research on drug dependence and potential new drug
applications for various drugs, and to treat drug dependence with or
without abuse potential. A new drug application is a notice to FDA that
a pharmaceutical company believes they have enough data to demonstrate
the safety and efficacy of a substance to satisfy FDA for marketing the
substance. FDA may also use the records in routine inspections that FDA
conducts in accordance with its responsibilities to develop standards
on the composition, quality, safety and efficacy of drugs administered
to humans, and to monitor experimental usage of drugs.
3. To conduct research on the pharmacology, toxicology, and
behavioral characteristics of drugs of abuse alone or in combination
with proposed treatment drugs.
NIH contractor(s) use the records in the system in order to
accomplish the research and development purposes for which the records
were collected. In the event of a followup study or continuation study,
the responsible project officer may disclose records in this system to
a subsequent NIH contractor(s). Any new contractor(s) is and would be
required to maintain Privacy Act safeguards with respect to such
records and to comply with the confidentiality restrictions of 42 CFR
part 2.
Interview and assessment forms, video tapes, magnetic tapes, disks
and microfiche in boxes in closed cabinets in a locked room with
limited accessibility. [[Page 4300]]
The records are indexed and retrieved by subject-participant's name
code (i.e., initials--not name) and unique numerical identifier. In
order to relate the data collected to specific individuals, however,
one must use the link file discussed under safeguards.
1. Authorized users: For the naltrexone study, the System Manger or
Federal Project Officer and only authorized contract staff have access
to the records (computerized and hard copy files) in the system. The
contractor provides only aggregate data in reports to NIDA, FDA, or the
public. Only the NIDA personnel mentioned previously and selected
authorized contract staff have access to the stored LAAM records.
A certificate of confidentiality has been issued to researchers
conducting the naltrexone study under 42 CFR, Part 2, Protection of
Identity--Research Subjects. This authorization enables persons engaged
in research on mental health, including research on the use and effect
of psychoactive drugs, to protect the privacy of research subjects by
withholding the names or other identifying characteristics from all
persons not connected with the conduct of the research. Persons so
authorized my not be compelled in any Federal, State or local civil,
criminal, administrative, legislative, or other proceedings to identify
such individuals. The earlier LAAM study (from 1975 through 1979) was
not conducted under a certificate of confidentiality. The 1992 LAAM
studies were conducted under the protection afforded by a
confidentiality certificate. These regulations do not prohibit
voluntary disclosure by the researcher. However, the records of these
studies also are subject to 42 CFR part 2, the Confidentiality of
Alcohol and Drug Abuse Patient Records Regulations (42 CFR 2.56), which
state: ``Where the content of patient records has been disclosed.
Pursuant to (these regulations) for the purpose of conducting
scientific research * * * information contained therein which would
directly or indirectly identify any patient may not be disclosed by the
recipient thereof either voluntarily of in response to any legal
process whether Federal or State.''
The contractor's institutional review board reviewed and approved
the safeguards described above in accordance with 45 CFR Part 46 on the
Protection of Human Subjects.
2. Physical safeguards: For the naltrexone records, the
contractor(s) stored individually identified forms in a locked room
with controlled entry, i.e., only on written authority of the
professional staff member in charge of data handling and processing).
The contractor staff entered the collected information onto computer
tape or disks as soon after contact with the subject-participant as
possible, and stores the computerized records in a secured area with
access limited as above.
For the LAAM, buprenorphine and other compound records, NIDA stores
the individually identified forms in a lockable cabinet in a secure
room. Only authorized NIDA personnel, i.e., Division of Clinical
Research and Medications Development professional staff and their
support staff (program assistant, clerk-typist, or secretary) have
access to the room with controlled entry. The room is in a building
which has a 24-hour guard/television surveillance system and has
controlled entry (picture identification sign in and out procedures)
before and after normal working hours.
Another safeguard for these studies is that the forms containing
subject identification information do not include any reference to the
purpose of the study. The identification information is separate from
any information that would suggest that the respondent is or has been
in a drug abuse treatment program. In addition, the computer center
being utilized for naltrexone has developed an extensive security
system to protect computer account codes and data.
3. Procedural safeguards: Access to the computerized records of the
studies (naltrexone and other research) is protected by a computerized
password routine which is changed periodically. In addition, the
project staff complies with the contractor's standard procedures for
safeguarding data. The link file system that identifies individuals
with personal data has three components: (1) Identification
information, (2) data base information, and (3) the link file, which
contains identifying number pairs which match data with individuals.
The advantage of this system is that one may use the baseline data
directly for report generation, etc., without using the subroutines or
accessing the personal information or link files.
4. Implementation guidelines: DHHS Chapter 45-13 and supplementary
Chapter PHS.hf: 45-13 of the General Administration Manual and Part 6,
``ADP System Security'' in the HHS ADP Systems Security Manual.
The naltrexone staff will destroy identifiable information by
shredding or burning when it is no longer needed for analysis or
research purposes; then the tapes will be erased. NIDA will destroy
individual identification and match-up information from other studies
by shredding or burning 5 years after FDA completes the review and
approves the new drug applications or when they are no longer needed
for research purposes.
NIDA will retain the aggregate data tapes and/or paper records from
studies for research purposes. These tapes will not have any
individually identifiable information. In accordance with the FDA
regulations governing new drug applications, the aggregate tapes will
be retained for at least 2 years after FDA approves the new drug
applications. At that time, the tapes will be retired to the Federal
Records Center and destroyed when they are 5 years old or when they are
no longer needed for research purposes.
Project Officer, Naltrexone Study, Division of Clinical Research,
Room 10A-30, Parklawn Building, National Institute on Drug Abuse, 5600
Fishers Lane, Rockville, MD 20857.
Project Officer, LAAM and Other Research Records, Medications
Development Division, Room 11A-55, Parklawn Building, National
Institute on Drug Abuse, 5600 Fishers Lane, Rockville, MD 20857.
An individual may determine if a record exists about himself/
herself upon written request, with notarized signature if request is
made by mail, or with suitable identification if request is made in
person, to the appropriate system manager at the address above. The
following information should be included, if known: Subject-
participant's full name and a letter of request with notarized
signature of the subject-participant of the record, any alias used,
subject-participant's identification number, name of the researcher,
name of clinic or research center, name of substance, and approximate
date of study participation.
An individual who requests notification of a medical record must,
at the time the request is made, designate in writing a responsible
representative who will be willing to review the record and inform the
subject individual of its contents at the representative's discretion.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. An individual may also
request [[Page 4301]] an accounting of disclosures of his/her record,
if any.
Contact the official at the address specified under notification
procedures above and reasonably identify the record, specify the
information being contested, the corrective action sought, with
supporting information to show how the record is inaccurate,
incomplete, untimely, or irrelevant.
Research subject-participants, staff in the participating drug
abuse treatment programs, written clinical evaluations, private
physicians, counselors, psychiatrists, psychotherapists, family
members, research assistants, and hospital records.
None.
09-25-0212
Clinical Research: Neuroscience Research Center Patient Medical
Records, HHS/NIH/NIMH.
None.
Neuroscience Research Center at Saint Elizabeths Hospital, William
A. White Building, Room 144, 2700 Martin Luther King, Jr., Avenue, SE.,
Washington, DC 20032, and at private organizations under contract. A
list of specific sites is available from the System Manager.
Registered clinical research patients and some individuals not
registered as patients but seen for diagnostic tests.
Inpatient and outpatient medical clinical records.
The Public Health Service Act, section 301 (42 U.S.C. 241),
``Research and Investigation,'' and Section 321 (42 U.S.C. 248),
``Hospital.''
(1) To provide a continuous history of the treatment afforded
individual patients in the National Institute of Mental Health
Neuroscience Research Center.
(2) To provide a data base for the clinical research conducted at
the Neuroscience Research Center.
1. Disclosure may be made to a congressional office from the record
of an individual in response to a verified inquiry from the
congressional office made at the written request of that individual.
2. Social work staff may give pertinent information to community
agencies to assist patients for their families.
3. Referring physicians receive medical information for continuing
patient care after discharge.
4. Information regarding diagnostic problems, or having unusual
scientific value may be disclosed to appropriate medical research
organizations or consultants in connection with treatment of patient or
in order to accomplish the research purposes of this system. For
example, tissue specimens may be sent to the Armed Forces Institute of
Pathology; x-rays may be sent for the opinion of a radiologist with
extensive experience in a particular kind of diagnostic radiology. The
recipients are required to maintain Privacy Act safeguards with respect
to these records.
5. Records may be disclosed to representative of the Joint
Commission on Accreditation of Hospitals conducting inspections to
ensure that the quality of the Neuroscience Research Center Program
medical recordkeeping meets established standards.
6. Certain infectious diseases are reported to government
jurisdictions as required by law.
7. Medical information may be disclosed to tumor registries for
maintenance for health statistics.
8. The Department contemplates that it may contract with a private
firm for transcribing, updating, copying or otherwise refining records
in this system. Relevant records will be disclosed to such a
contractor. The contractor will be required to comply with the
requirements of the Privacy Act with respect to such records.
9. In the event of litigation where the defendant is (a) the
Department, any component of the Department, or any employee of the
Department in his or her official capacity; (b) the United States where
the Department determines that the claim, if successful, is likely to
directly affect the operation of the Department or any of its
components; or (c) any Department employee in his or her individual
capacity where the Justice Department has agreed to represent such
employee, for example in defending a claim against the Public Health
Service based upon an individual's metal or physical condition and
alleged to have arisen because of activities of the Public Health
Service in connection with such individual, disclosure may be made to
the Department of Justice to enable that Department to present an
effective defense, provided that such disclosure is compatible with the
purpose for which the records were collected.
Records are stored in file folders and/or on microfiche, and on
computer tapes. Files are stored in locked file cabinets or locked
rooms.
The records are retrieved by hospital number and patient name.
1. Authorized users: Employees maintaining records in this system
are instructed to grant regular access only to physicians and dentists
and other health care professionals officially participating in patient
care and to contractors or to NIMH researchers specifically authorized
by the system manager.
2. Physical safeguard: All record facilities are locked when system
personnel are not present.
3. Procedural safeguards: Access to files is strictly controlled by
the system manager. Records may be removed only by system personnel
following receipt of a request signed by authorized user. Access to
computerized records is controlled by the use of security codes known
only to the authorizer user. Codes are user- and function-specific.
Contractor compliance is assured through inclusion of Privacy Act
requirements in contract clauses, and through monitoring by contract
and project officers. Contractors who maintain records in this system
are instructed to make no disclosure of the records except as
authorized by the system manager.
4. Implementation guidelines: DHHS Chapter 45-13 and supplementary
Chapter PHS.hf: 45-13 of the General Administration Manual, and Part 6,
``ADP System Security'' in the HHS Information Resource Management
Manual.
Records are retained for 20 years after last discharge or upon
death of a patient and then transferred to the Washington National
Records Center, where they are retained until 30 years after discharge
or death. [[Page 4302]]
Clinical Director, Neuroscience Research Center, Division of
Intramural Research Programs, National Institute of Mental Health,
Saint Elizabeths Hospital, Room 133, William A. White Building, 2700
Martin Luther King Jr., Avenue, SE., Washington, DC 20032.
To determine if a record exists, write to the System manager at the
address above. An individual or a legally authorized representative may
learn if a record exists about that individual upon written request
with notarized signature. The request should include: (a) Full name or
any alias used, (b) social security number, and (c) approximate time of
participation in the hospital/project.
An individual who requests notification of or access to a medical
record shall, at the time the request is made, designate in writing a
family physician or health professional (other than a family member) to
whom the record will be released. The representative must verify
relationship to the individual as well as his/her own identity.
A parent or guardian who requests notification of, or access to, a
child's/incompetent person's medical record shall designate a family
physician or other health professional (other than a family member) to
whom the record, if any, will be sent. The parent or guardian must
verify relationship to the child/incompetent person as well as his/her
own identity.
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
an accounting of disclosures of their records, if any.
Contact the System Manager at the address specified under
Notification Procedures above and reasonably identify the record,
specify the information being contested, and state the corrective
action sought and the reasons for correcting the information, along
with supporting justification to show how the record is inaccurate,
incomplete, or irrelevant.
Referring physicians, other medical facilities (with patient's
consent), patients, relatives of patients.
None.
[FR Doc. 95-992 Filed 1-19-95; 8:45 am]
BILLING CODE 4101-01-M
