[Federal Register Volume 64, Number 229 (Tuesday, November 30, 1999)]
[Corrections]
[Pages 66970-67026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30419]
[[Page 66969]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
National Institutes of Health
_______________________________________________________________________
Privacy Act of 1974; Annual Publication of Systems of Records; Notices
Federal Register / Vol. 64, No. 229, Tuesday, November 30, 1999 /
Notices
[[Page 66970]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Privacy Act of l974; Annual Publication of Systems of Records
AGENCY: National Institutes of Health, 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 October 16, 1999.
SUPPLEMENTARY INFORMATION: The following information summarizes the
current status of systems of records which had minor modifications
during 1998 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:
09-25-0105, Administration: Health Records of Employees, Visiting
Scientists, Fellows, and Others Who Receive Medical Care Through the
Employee Health Unit, HHS/NIH/ORS.
09-25-0106, Administration: Office of the NIH Director and
Institute/Center Correspondence Records, HHS/NIH/OD.
09-25-0161, Administration: NIH Consultant File, HHS/NIH/CSR.
09-25-0168, Invention, Patent, and Licensing Documents Submitted to
the Public Health Service by its Employees, Grantees Fellowship
Recipients, and Contractors, HHS/PHS/FDA/NIH/OTT.
B. System Location
The following systems have been updated to reflect a change in the
system location or location address. These changes do not affect the
access by the individual to the individual's records.
09-25-0005, Administration: Library Operations and User I.D. File,
HHS/NIH/OD.
09-25-0012, Clinical Research: Candidate Normal Volunteer Records,
HHS/NIH/CC.
09-25-0054, Administration: Property Accounting, HHS/NIH/ORS.
09-25-0087, Administration: Senior Staff, HHS/NIH/NIAID.
09-25-0105, Administration: Health Records of Employees, Visiting
Scientists, Fellows, and Others Who Receive Medical Care Through the
Employee Health Unit, HHS/NIH/ORS.
09-25-0106, Administration: Office of the NIH Director and
Institute/Center 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.
09-25-0115, Administration: Curricula Vitae of Consultants and
Clinical Investigators, HHS/NIH/NIAID.
09-25-0118, Contracts: Professional Services Contractors, HHS/NIH/
NCI.
09-25-0124, Administration: Pharmacology Research Associates, HHS/
NIH/NIGMS.
09-25-0140, International Activities: International Scientific
Researchers in Intramural Laboratories at the National Institutes of
Health, HHS/NIH/FIC.
09-25-0168, Invention, Patent, and Licensing Documents Submitted to
the Public Health Service by its Employees, Grantees, Fellowship
Recipients, and Contractors, HHS/PHS/FDA/NIH/OTT.
09-25-0169, Medical Staff-Credentials Files, HHS/NIH/CC.
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, Intramural Research
Program, 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.
09-25-0210, Shipment Records of Drugs of Abuse to Authorized
Researchers, 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.
09-25-0054, Administration: Property Accounting, HHS/NIH/ORS.
09-25-0105, Administration: Health Records of Employees, Visiting
Scientists, Fellows, and Others Who Receive Medical Care Through the
Employee Health Unit, HHS/NIH/ORS.
09-25-0140, International Activities: International Scientific
Researchers in Intramural Laboratories at the National Institutes of
Health, HHS/NIH/FIC.
09-25-0209, Subject-Participants in Drug Abuse Research Studies on
Drug Dependence and in Research Supporting New Drug Applications,
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.
09-25-0005, Administration: Library Operations and User I.D. File,
HHS/NIH/OD.
09-25-0106, Administration: Office of the NIH Director and
Institute/Center Correspondence Records, HHS/NIH/OD.
09-25-0140, International Activities: International Scientific
Researchers in Intramural Laboratories at the National Institutes of
Health, HHS/NIH/FIC.
09-25-0168, Invention, Patent, and Licensing Documents Submitted to
the Public Health Service by its Employees, Grantees, Fellowship
Recipients, and Contractors, HHS/PHS/FDA/NIH/OTT.
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.
09-25-0112, Grants and Cooperative Agreements: Research, Research
Training, Fellowship and Construction Applications and Related
Awards, HHS/NIH/OD.
09-25-0168, Invention, Patent, and Licensing Documents Submitted to
the Public Health Service by its Employees, Grantees, Fellowship
Recipients, and Contractors, HHS/PHS/FDA/NIH/OTT.
09-25-0200, Clinical, Epidemiologic, and Biometric Studies of the
National Institutes of Health (NIH), HHS/NIH/OD.
F. Storage
The following systems have been updated to reflect a change in
system storage practices:
09-25-0140, International Activities: International Scientific
Researchers in Intramural Laboratories at the National Institutes of
Health, HHS/NIH/FIC.
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.
G. Retrieval
The following systems have been updated to reflect a change in
retrieval practices.
09-25-0168, Invention, Patent, and Licensing Documents Submitted to
the Public Health Service by its Employees, Grantees, Fellowship
Recipients, and Contractors, HHS/PHS/FDA/NIH/OTT.
H. Safeguards
The following systems have been updated to reflect a change in
safeguard practices.
09-25-0014, Clinical Research: Student Records, HHS/NIH/CC.
[[Page 66971]]
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.
09-25-0168, Invention, Patent, and Licensing Documents Submitted to
the Public Health Service by its Employees, Grantees, Fellowship
Recipients, and Contractors, HHS/PHS/FDA/NIH/OTT.
09-25-0210, Shipment Records of Drugs of Abuse to Authorized
Researchers, HHS/NIH/NIDA.
I. Retention and Disposal
The following systems have been updated to reflect a change in
retention and disposal:
09-25-0012, Clinical Research: Candidate Normal Volunteer Records,
HHS/NIH/CC.
09-25-0106, Administration: Office of the NIH Director and
Institute/Center 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.
09-25-0165, National Institutes of Health Loan Repayment Program,
HHS/NIH/OD.
09-25-0168, Invention, Patent, and Licensing Documents Submitted to
the Public Health Service by its Employees, Grantees, Fellowship
Recipients, and Contractors, HHS/PHS/FDA/NIH/OTT.
09-25-0203, National Institute on Drug Abuse, Intramural Research
Program, Federal Prisoner and Non-Prisoner Research Files, HHS/NIH/
NIDA.
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.
09-25-0005, Administration: Library Operations and User I.D. File,
HHS/NIH/OD.
09-25-0012, Clinical Research: Candidate Normal Volunteer Records,
HHS/NIH/CC.
09-25-0014, Clinical Research: Student Records, HHS/NIH/CC.
09-25-0034, International Activities: Scholars-in-Residence Program,
HHS/NIH/FIC.
09-25-0054, Administration: Property Accounting, HHS/NIH/ORS.
09-25-0087, Administration: Senior Staff, HHS/NIH/NIAID.
09-25-0099, Clinical Research: Patient Medical Records, HHS/NIH/CC.
09-25-0106, Administration: Office of the NIH Director and
Institute/Center 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.
09-25-0124, Administration: Pharmacology Research Associates, HHS/
NIH/NIGMS.
09-25-0140, International Activities: International Scientific
Researchers in Intramural Laboratories at the National Institutes of
Health, HHS/NIH/FIC.
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/CSR.
09-25-0166, Administration: Radiation and Occupational Safety and
Health Management Information Systems, 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/FDA/NIH/OTT.
09-25-0169, Medical Staff-Credentials Files, HHS/NIH/CC.
09-25-0200, Clinical, Epidemiologic, and Biometric Studies of the
National Institutes of Health (NIH), HHS/NIH/OD.
09-25-0207, Subject-Participants in Pharmacokinetic Studies on Drugs
of Abuse and on Treatment Medications, HHS/NIH/NIDA.
09-25-0208, Drug Abuse Treatment Outcome Study (DATOS), 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.
09-25-0210, Shipment Records of Drugs of Abuse to Authorized
Researchers, HHS/NIH/NIDA.
K. Record Access
The following systems have been updated to reflect a change in the
record access procedure.
09-25-0112, Grants and Cooperative Agreements: Research, Research
Training, Fellowship and Construction Applications and Related
Awards, HHS/NIH/OD.
L. Notification Procedure
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.
09-25-0112, Grants and Cooperative Agreements: Research, Research
Training, Fellowship and Construction Applications and Related
Awards, 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.
09-25-0200, Clinical, Epidemiologic and Biometric Studies of the
National Institutes of Health (NIH), HHS/NIH/OD.
M. The Following Systems Have Been Changed for Clarity and Editing
Purposes
09-25-0014, Clinical Research: Student Records, HHS/NIH/CC.
09-25-0140, International Activities: International Scientific
Researchers in Intramural Laboratories at the National Institutes of
Health, HHS/NIH/FIC.
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.
09-25-0168, Invention, Patent, and Licensing Documents Submitted to
the Public Health Service by its Employees, Grantees, Fellowship
Recipients, and Contractors, HHS/PHS/FDA/NIH/OTT.
09-25-0169, Medical Staff-Credentials Files, HHS/NIH/CC.
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 last annual
publication are now being deleted because:
09-25-0035, International Activities: Health Scientist Exchange
Programs, HHS/NIH/FIC.
The records have been destroyed
09-25-0091, Administration: General Files on Employees, Donors and
Correspondents, HHS/NIH/NEI.
The records have been destroyed
09-25-0102, Administration: Grants Associates Program Working Files,
HHS/NIH/OER.
The records have been destroyed.
The following is a list of active systems of records maintained by
NIH.
Table of Contents
09-25-0005, Administration: Library Operations and User I.D. File,
HHS/NIH/OD, publ. Privacy Act Issuances, 1997 Compilations Online
via GPO Access.
09-25-0007, Administration: NIH Safety Glasses Issuance Program,
HHS/NIH/ORS, publ. Privacy Act Issuances, 1997 Compilations Online
via GPO Access.
09-25-0011, Clinical Research: Blood Donor Records, HHS/NIH/CC,
publ. Privacy Act Issuances, 1997 Compilations Online via GPO
Access.
09-25-0012, Clinical Research: Candidate Normal Volunteer Records,
HHS/NIH/CC, publ. Privacy Act Issuances, 1997 Compilations Online
via GPO Access.
09-25-0014, Clinical Research: Student Records, HHS/NIH/CC, publ.
Privacy Act Issuances, 1997 Compilations Online via GPO Access.
09-25-0033, International Activities: Fellowships Awarded by Foreign
Organizations, HHS/NIH/FIC, publ. Privacy Act Issuances, 1997
Compilations Online via GPO Access.
[[Page 66972]]
09-25-0034, International Activities: Scholars-in-Residence Program,
HHS/NIH/FIC, publ. Privacy Act Issuances, 1997 Compilations Online
via GPO Access.
09-25-0036, Extramural Awards and Chartered Advisory Committees:
IMPAC (Grant/Contract/Cooperative Agreement/Chartered Advisory
Committee Information), HHS/NIH/CSR and HHS/NIH/CMO, published
Federal Register, Vol. 63, No. 122, June 25, 1998.
09-25-0041, Research Resources: Scientists Requesting Hormone
Distribution, HHS/NIH/NIDDK, publ. Privacy Act Issuances, 1997
Compilations Online via GPO Access.
09-25-0054, Administration: Property Accounting, HHS/NIH/ORS, publ.
Privacy Act Issuances, 1997 Compilations Online via GPO Access.
09-25-0078, Administration: Consultant File, HHS/NIH/NHLBI, publ.
Privacy Act Issuances, 1997 Compilations Online via GPO Access.
09-25-0087, Administration: Senior Staff, HHS/NIH/NIAID, publ.
Privacy Act Issuances, 1997 Compilations Online via GPO Access.
09-25-0093, Administration: Authors, Reviewers, Editorial Board, and
Members of the Journal of the National Cancer Institute, HHS/NIH/
NCI, publ. Privacy Act Issuances, 1997 Compilations Online via GPO
Access.
09-25-0099, Clinical Research: Patient Medical Records, HHS/NIH/CC,
publ. Privacy Act Issuances, 1997 Compilations Online via GPO
Access.
09-25-0105, Administration: Health Records of Employees, Visiting
Scientists, Fellows, and Others Who Receive Medical Care Through the
Employee Health Unit, HHS/NIH/ORS, publ. Privacy Act Issuances, 1997
Compilations Online via GPO Access.
09-25-0106, Administration: Office of the NIH Director and
Institute/Center Correspondence Records, HHS/NIH/OD, publ. Privacy
Act Issuances, 1997 Compilations Online via GPO Access.
09-25-0108, Personnel: Guest Researchers, Special Volunteers, and
Scientists Emeriti, HHS/NIH/OHRM, publ. Privacy Act Issuances, 1997
Compilations Online via GPO Access.
09-25-0112, Grants and Cooperative Agreements: Research, Research
Training, Fellowship and Construction Applications and Related
Awards, HHS/NIH/OD, publ. Privacy Act Issuances, 1997 Compilations
Online via GPO Access.
09-25-0115, Administration: Curricula Vitae of Consultants and
Clinical Investigators, HHS/NIH/NIAID, publ. Privacy Act Issuances,
1997 Compilations Online via GPO Access.
09-25-0118, Contracts: Professional Services Contractors, HHS/NIH/
NCI, publ. Privacy Act Issuances, 1997 Compilations Online via GPO
Access.
09-25-0121, International Activities: Senior International
Fellowships Program, HHS/NIH/FIC, publ. Privacy Act Issuances, 1997
Compilations Online via GPO Access.
09-25-0124, Administration: Pharmacology Research Associates, HHS/
NIH/NIGMS, publ. Privacy Act Issuances, 1997 Compilations Online via
GPO Access.
09-25-0140, International Activities: International Scientific
Researchers in Intramural Laboratories at the National Institutes of
Health, HHS/NIH/FIC, publ. Privacy Act Issuances, 1997 Compilations
Online via GPO Access.
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, publ. Privacy Act Issuances, 1997 Compilations Online
via GPO Access.
09-25-0158, Administration: Records of Applicants and Awardees of
the NIH Intramural Research Training Awards Program, HHS/NIH/OD,
publ. Privacy Act Issuances, 1997 Compilations Online via GPO
Access.
09-25-0160, United States Renal Data System (USRDS), HHS/NIH/NIDDK
publ. Privacy Act Issuances, 1997 Compilations Online via GPO
Access.
09-25-0161, Administration: NIH Consultant File, HHS/NIH/CSR, publ.
Privacy Act Issuances, 1997 Compilations Online via GPO Access.
09-25-0165, National Institutes of Health Loan Repayment Program,
HHS/NIH/OD, publ. Privacy Act Issuances, 1997 Compilations Online
via GPO Access.
09-25-0166, Administration: Radiation and Occupational Safety and
Health Management Information Systems, HHS/NIH/ORS, publ. Privacy
Act Issuances, 1997 Compilations Online via GPO Access.
09-25-0167, National Institutes of Health (NIH) TRANSHARE Program,
HHS/NIH/OD, publ. Privacy Act Issuances, 1997 Compilations Online
via GPO Access.
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, publ. Privacy Act
Issuances, 1997 Compilations Online via GPO Access.
09-25-0169, Medical Staff-Credentials Files, HHS/NIH/CC, publ.
Privacy Act Issuances, 1997 Compilations Online via GPO Access.
09-25-0200, Clinical, Epidemiologic, and Biometric Studies of the
National Institutes of Health (NIH), HHS/NIH/OD, published Federal
Register, Vol. 62, No. 66, Monday, April 7, 1997.
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, publ. Privacy Act Issuances, 1997 Compilations Online via GPO
Access.
09-25-0203, National Institute on Drug Abuse, Intramural Research
Program, Federal Prisoner and Non-Prisoner Research Files, HHS/NIH/
NIDA, publ. Privacy Act Issuances, 1997 Compilations Online via GPO
Access.
09-25-0207, Subject-Participants in Pharmacokinetic Studies on Drugs
of Abuse and on Treatment Medications, HHS/NIH/NIDA, publ. Privacy
Act Issuances, 1997 Compilations Online via GPO Access.
09-25-0208, Drug Abuse Treatment Outcome Study (DATOS), HHS/NIH/
NIDA, publ. Privacy Act Issuances, 1997 Compilations Online via GPO
Access.
09-25-0209, Subject-Participants in Drug Abuse Research Studies on
Drug Dependence and in Research Supporting New Drug Applications,
HHS/NIH/NIDA, publ. Privacy Act Issuances, 1997 Compilations Online
via GPO Access.
09-25-0210, Shipment Records of Drugs of Abuse to Authorized
Researchers, HHS/NIH/NIDA, publ. Privacy Act Issuances, 1997
Compilations Online via GPO Access.
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, publ. Privacy Act Issuances, 1997 Compilations Online via
GPO Access.
Dated: November 17, 1999.
Timothy J. Wheeles,
Director, Division of Management Support, OMA, OA, National Institutes
of Health.
09-25-0005
SYSTEM NAME:
Administration: Library Operations and User I.D. File, HHS/NIH/OD.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
This system of records is an umbrella system comprising separate
sets of 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 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
[[Page 66973]]
National Technical Information Service, Accounting Department, 8001
Forbes Place, Room 208F, Springfield, VA 22151.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Users of Library Services.
CATEGORIES OF RECORDS IN THE SYSTEM:
Name, organization, address, phone number, photographs, issue date,
email address, signature, user code and identification number; and when
applicable, credit card number and billing information.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
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).
PURPOSE(S):
1. To monitor library material, services, and circulation control.
2. To provide user documentation.
3. To provide copying services (duplication of library materials).
4. To manage invoice and billing transactions for library services.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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 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 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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored on computer tape and disk, microfiche, paper and
file cards.
RETRIEVABILITY:
Records are retrieved by name, user code and/or identification
number.
SAFEGUARDS:
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 the HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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 six years. Refer to the NIH
Manual Chapter for specific conditions on disposal.
SYSTEM MANAGER(S) AND ADDRESS:
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.
Head, Quality Assurance Unit, 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.
Chief, Public Services Division, Library Operations, National
Library of Medicine, National Institutes of Health, Building 38, Room
1S33, 8600 Rockville Pike, Bethesda, MD 20894.
Librarian, History of Medicine Division, NLM, NIH, Building 38,
Room 1N21, 8600 Rockville Pike, Bethesda, MD 20894.
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.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
Same as Notification Procedure. Requesters should also reasonably
specify the record contents being
[[Page 66974]]
sought. Individuals may also request an accounting of disclosures that
have been made of their records, if any.
CONTESTING RECORD PROCEDURE:
Write to the official at the address specified under Notification
Procedure 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).
RECORD SOURCE CATEGORIES:
Individual, NIH Library ID card data.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0007
SYSTEM NAME:
Administration: NIH Safety Glasses Issuance Program, HHS/NIH/ORS.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Building 13, Room G904, National Institutes of Health, 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.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
NIH employees who apply for safety glasses.
CATEGORIES OF RECORDS IN THE SYSTEM:
Explanation of eye impact and hazard occupation.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
5 U.S.C. 7902.
PURPOSE(S):
Records are used for proper distribution of safety glasses and for
proof of delivery.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in file folders.
RETRIEVABILITY:
Records are retrieved by name.
SAFEGUARDS:
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 personnel involved in
safety glasses issuance program, to supervisors of employees who have
requested glasses, and to personnel involved in accounting.
2. Physical Safeguards: Record storage locations are locked when
unattended.
3. Procedural Safeguards: Access to file rooms and files is
controlled by system manager or designee.
RETENTION AND DISPOSAL:
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-3, which allows records to be kept for a
maximum period of five years. Refer to the NIH Manual Chapter for
specific disposition instructions.
SYSTEM MANAGER(S) AND ADDRESS:
Deputy Director, Division of Safety, ORS, Building 31, Room 1C02,
9000 Rockville Pike, Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Write to the official at the address specified under Notification
Procedure 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 information to 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).
RECORD SOURCE CATEGORIES:
Previous employer and education institutions.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0011
SYSTEM NAME:
Clinical Research: Blood Donor Records, HHS/NIH/CC.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institutes of Health, Transfusion Medicine Department, 10
Center Drive, MSC 1184, Bethesda, MD 20892-1184.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Donors of blood and blood components to be used in the NIH Clinical
Center for patient infusions.
[[Page 66975]]
CATEGORIES OF RECORDS IN THE SYSTEM:
Past donations, blood types, phenotypes. Laboratory results of
hepatitis testing, serologic reactions on all blood samples, donations
of blood or blood components.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
``Preparation of Biological Products'' of the Public Health Service
Act (42 U.S.C. 263).
PURPOSE(S):
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.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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 an 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 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.
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).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in a computer file, on donor cards, and on
microfilm.
RETRIEVABILITY:
Records are retrieved by a unique control number assigned to each
individual donor.
SAFEGUARDS:
Access is granted only to authorized employees in the Department of
Transfusion Medicine including 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 the HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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-50. Refer to the NIH Manual Chapter for
specific conditions on disposal.
SYSTEM MANAGER(S) AND ADDRESS:
Chief, Transfusion Medicine Department, National Institutes of
Health, 10 Center Drive, MSC 1184, Bethesda, MD 20892-1184.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
To obtain access to a record, contact the system manager at the
address specified above. Requesters should provide the same information
as is required under the Notification Procedure above. Individuals may
also request listings of accountable disclosures that have been made of
their records, if any.
CONTESTING RECORD PROCEDURE:
Write to the official specified under Notification Procedure 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).
[[Page 66976]]
RECORD SOURCE CATEGORIES:
Data are collected from the individual.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0012
SYSTEM NAME:
Clinical Research: Candidate Normal Volunteer Records, HHS/NIH/CC.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Clinical Research Volunteer Program, 10 Cloister Ct., Bldg. 61,
Bethesda, MD 20892-4754.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Normally healthy individuals who volunteer to participate in NIH
studies.
CATEGORIES OF RECORDS IN THE SYSTEM:
Program application, health questionnaire and record of
participation.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 241, 263.
PURPOSE(S):
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.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Program applications and health questionnaires are stored in file
folders. Records of participation are stored on index cards.
RETRIEVABILITY:
Records are retrieved by name.
SAFEGUARDS:
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.
RETENTION AND DISPOSAL:
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 for a
maximum period of three years after the volunteer period ends. Refer to
the NIH Manual Chapter for specific conditions on disposal.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Clinical Research Volunteer Program, 10 Cloister Ct.,
Bldg. 61, Bethesda, MD 20892-4745.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
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 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.
CONTESTING RECORD PROCEDURE:
Write to the official at the address specified under Notification
Procedure 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).
RECORD SOURCE CATEGORIES:
Volunteer, sponsoring contractor.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0014
SYSTEM NAME:
Clinical Research: Student Records, HHS/NIH/CC.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
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.
[[Page 66977]]
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Potential and accepted Medical Staff and Research Fellows, medical
students, and other students in NIH training programs.
CATEGORIES OF RECORDS IN THE SYSTEM:
Application form, transcripts, references, evaluations.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 241.
PURPOSE(S):
1. To identify candidates for clinical 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.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
1. Information may be used to respond to congressional inquiries
regarding constituents who have applied for training programs.
2. Information may be used to respond to prospective employers who
seek training verification on NIH alumni.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in file folders.
RETRIEVABILITY:
Records are retrieved by name and year.
SAFEGUARDS:
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 candidates
for training programs.
2. Physical Safeguards: Records are maintained in locked cabinets
with access limited to authorized personnel, including the systems
manager and staff in the Office of Education.
3. Procedural safeguards: Access to the files is strictly
controlled by the staff. Records may be removed from the file only at
the request of the system manager or other authorized employees.
RETENTION AND DISPOSAL:
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 ten years. Refer to the NIH Manual Chapter
for specific disposition instructions.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Office of Education, National Institutes of Health, Bldg.
10, Room 1C129, 10 Center Drive, MSC 1158, Bethesda, MD 20892-1158.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
To obtain access to a record, contact the system manager at the
above address and provide the information described under 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.
CONTESTING RECORD PROCEDURE:
Write to the system manager at the address specified 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).
RECORD SOURCE CATEGORIES:
Applicants, universities and teachers.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0033
SYSTEM NAME:
International Activities: Fellowships Awarded by Foreign
Organizations, HHS/NIH/FIC.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institutes of Health, Building 31, Room B2C29, 9000
Rockville Pike, Bethesda, MD 20892.
Write to system manager at the address below for the address of any
Federal Records Center where records from this system may be stored.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
U.S. citizens qualified in health-related sciences submitting
applications through NIH for fellowships for study abroad.
CATEGORIES OF RECORDS IN THE SYSTEM:
Applications and associated records and reports.
PURPOSE(S):
To perform scientific reviews and evaluations of applicants'
suitability of referral to awarding organization in foreign countries.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 2421.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
1. After review by the operating agency review panel the
applications and all supporting documents are forwarded to the foreign
organizations or agencies making awards.
2. In addition, such application may be made available to
authorized employees and agents of the Federal Government for purposes
of investigations, inspections and audits, and, in appropriate cases,
to the Department of Justice for prosecution under civil and criminal
laws.
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 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
[[Page 66978]]
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in file folders.
RETRIEVABILITY:
Records are retrieved by name and fellowship number.
SAFEGUARDS:
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 FIC program 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: The records are maintained in locked file
cabinets, and offices are locked during off-duty hours.
3. Procedural Safeguards: Access to file rooms and 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.
RETENTION AND DISPOSAL:
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 2300-320-5, which allows records to be destroyed
after a maximum period of six years after the close of a case. Refer to
the NIH Manual Chapter for specific disposition instructions.
SYSTEM MANAGER(S) AND ADDRESS:
Fogarty International Center, Chief, International Research Awards
Branch, National Institutes of Health, Building 31, Room B2C29, 9000
Rockville Pike, Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
Requests for notification of or access to records should be
addressed to the system manager, as 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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Contact the official under Notification Procedure above, 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.
RECORD SOURCE CATEGORIES:
Applicants and persons supplying references.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0034
SYSTEM NAME:
International Activities: Scholars-in-Residence Program, HHS/NIH/
FIC.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institutes of Health, Building 16, Room 202, 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.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Distinguished scientists and scholars invited to accept NIH
scholarships.
CATEGORIES OF RECORDS IN THE SYSTEM:
Employment and education histories; references.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 2421, ``International Cooperation'' of the PHS Act.
PURPOSE(S):
To administer and award scholarships to distinguished scientists.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
1. Information is made available to authorized employees and agents
of the Federal Government for purposes of investigations, inspections
and audits, and in appropriate cases, to the Department of Justice for
prosecution under civil and criminal laws.
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. 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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in file folders.
RETRIEVABILITY:
Records are retrieved by name.
SAFEGUARDS:
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 FIC program 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.
[[Page 66979]]
2. Physical safeguards: Records are kept in file cabinets. Offices
are locked during off-duty hours.
3. Procedural safeguards: Access to files is strictly controlled by
files staff. Files may be removed only at the request of the system
manager or other authorized employee.
RETENTION AND DISPOSAL:
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 2300-320-7 which allows records to be destroyed
after a maximum period of six years after the close of a case. Refer to
the NIH Manual Chapter for specific retention instructions.
SYSTEM MANAGER(S) AND ADDRESS:
Acting Director, Division of International Advanced Studies,
Fogarty International Center, National Institutes of Health, Building
16, Room 202, 31 Center Drive, MSC 6705, Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
Requests for notification of or access to records should be
addressed to the system manager, as 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.
RECORD ACCESS PROCEDURES:
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.
CONTESTING RECORD PROCEDURE:
Contact the official under Notification Procedure 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).
RECORD SOURCE CATEGORIES:
Information is obtained from invitees, reference sources, and
persons supplying recommendations.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0036
SYSTEM NAME:
Extramural Awards and Chartered Advisory Committees: IMPAC (Grant/
Contract/Cooperative Agreement Information/Chartered Advisory Committee
Information), HHS/NIH/OER and HHS/NIH/CMO.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Rockledge Centre II, 6701 Rockledge Drive, Bethesda, MD 20817.
Building 12, NIH Computer Center, 9000 Rockville Pike, Bethesda, MD
20892.
Building 31, Room 3B-59, 9000 Rockville Pike, Bethesda, MD 20892.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Principal investigators; program directors; program and projects
staff and others named in the application; National Research Service
Awards (NRSA) trainees and fellows; research career awardees; chartered
advisory committee members; contractor personnel; subcontractor
personnel; and consultants.
CATEGORIES OF RECORDS IN THE SYSTEM:
Funding applications, awards, associated records, trainee
appointments, current and historical information pertaining to
chartered advisory committees, and past performance information
pertaining to contractors.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
5 U.S.C. 301; 42 U.S.C. 217a, 241, 282(b)(6), 284a, and 288. 48 CFR
subpart 15.3 and subpart 42.15.
PURPOSE(S):
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 database 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.
4. To maintain current and historical information pertaining to
contracts awarded by the National Institutes of Health, and performance
evaluations on NIH contracts and contracts awarded by other Federal
agencies that participate in the NIH Contractor Performance System.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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 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. Disclosure of past performance information pertaining to
contractors may be made to a Federal agency upon request. In addition,
routine access to past performance information on contractors will be
provided to Federal agencies that subscribe to the NIH Contractor
Performance System.
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) justifies 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
[[Page 66980]]
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 that 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.
8. Disclosure may be made to a private contractor or Federal agency
for the purpose of collating, analyzing, aggregating or otherwise
refining records in this system. The contractor or Federal agency will
be required to maintain Privacy Act safeguards with respect to these
records.
9. Disclosure may be made to a grantee or contract institution in
connection with performance or administration under the conditions of
the particular award or contract.
10. Disclosure may be made to the Department of Justice, or to a
court or other adjudicative body, from this system of records when (a)
HHS, or any component thereof; or (b) any HHS officer or employee in
his or her official capacity; or (c) any HHS officer or 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 officer or
employee; or (d) the United States or any agency thereof where HHS
determines that the proceeding is likely to affect HHS or any of its
components, is a party to proceeding or has any interest in the
proceeding, and HHS determines that the records are relevant and
necessary to the proceeding and would help in the effective
representation of the governmental party.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are retrieved by name, application, grant or contract ID
number, and contractor tax ID number.
RETRIEVABILITY:
Records are retrieved by name, application, grant or contract ID
number, and contractor tax ID number.
SAFEGUARDS:
1. Authorized Users: Employees who maintain records in this system
are instructed to grant regular access only to NIH extramural and
committee management staff, NIH contract management staff, and Federal
acquisition personnel. 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 Office of Extramural
Research (OER) work areas is restricted to OER employees. Physical
access to Office of Contracts Management (OCM) work areas is restricted
to OCM employees. Physical access to Committee Management Office (CMO)
work areas is restricted to CMO employees. Access to the contractor
performance files is restricted through the use of secure socket layer
encryption and through an IBM password protection system. Only
authorized government contracting personnel are permitted access.
Access is monitored and controlled by OCM.
3. Procedural Safeguards: Access to source data files 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, and similar limited access systems.
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 HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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.
SYSTEM MANAGER(S) AND ADDRESS:
For extramural awards: Director, Extramural Information Systems,
OD/OER/OPERA, Rockledge II, Room 2172, Bethesda, MD 20892.
For chartered Federal advisory committees of the National
Institutes of Health: NIH Committee Management Officer, Building 31,
Room 3B-59, 31 Center Drive, Bethesda, MD 20892.
For contracts: Office of Contracts Management, 6100 Executive
Boulevard, Room 6D01, Rockville, MD 20892.
NOTIFICATION PROCEDURE:
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
Privacy Act, subject to a five thousand dollar fine.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Contact the official 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, with supporting justification. The right to contest
records is limited to information which is incomplete, irrelevant,
incorrect, or untimely (obsolete).
RECORD SOURCE CATEGORIES:
Applicant institution, individual, individual's educational
institution and references, and participating Federal acquisition
personnel.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0041
SYSTEM NAME:
Research Resources: Scientists Requesting Hormone Distribution,
HHS/NIH/NIDDK.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Westwood Building, Room 605, NIH, 5333 Westbard Avenue, Bethesda,
MD 20892.
[[Page 66981]]
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Scientists requesting hormones from the National Institute of
Diabetes, and Digestive and Kidney Diseases (NIDDK).
CATEGORIES OF RECORDS IN THE SYSTEM:
Justification for request for hormones, including requester's
competence.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 241, 263, 289a, 289c.
PURPOSE(S):
1. For review of applications requesting hormones and antibodies
for research purposes, prior to awarding these substances.
2. To determine if the requester is qualified to receive these
materials.
3. To determine if requests for human hormones for clinical
research follow acceptable protocols. In this connection, records may
be disclosed to the Food and Drug Administration.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
1. Disclosure may be made to NIDDK Contractors for distribution of
various hormones to requesters.
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
Department to present an effective defense, provided that such
disclosure is compatible with the purpose for which the records were
collected.
Records may be disclosed to student volunteers, individuals working
under a personal services contract, and other individuals performing
functions for PHS who do not technically have the status of agency
employees, if they need the records in the performance of their agency
functions.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in file folders.
RETRIEVABILITY:
Records are retrieved by name.
SAFEGUARDS:
1. Authorized Users: Employees who maintain records in this system
are instructed to grant regular access only to staff working for the
contractor who need the records for hormone distribution, to NIH staff
who supervise the Hormone Distribution Program, and, as approved by the
system manager, to scientists and physicians who may have need of the
information for research.
2. Physical Safeguards: Records are kept in cabinets in offices
which are locked during off-duty hours and which have alarms.
3. Procedural Safeguards: Access to files is strictly controlled by
files staff. Files may be obtained only at the request of the system
manager or other authorized employee.
RETENTION AND DISPOSAL:
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.
SYSTEM MANAGER(S) AND ADDRESS:
Hormone Distribution Officer, Westwood Building, Room 605, NIH,
5333 Westbard Avenue, Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
To determine if a record exists write to: Administrative Officer,
NIDDK, Building 31, Room 9A46, 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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Contact the official 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, with supporting justification. The right to contest
records is limited to information which is incomplete, irrelevant,
incorrect, or untimely (obsolete).
RECORD SOURCE CATEGORIES:
Data is obtained from the individual.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0054
SYSTEM NAME:
Administration: Property Accounting, HHS/NIH/ORS.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institutes of Health, Computer Center, Building 12, 9000
Rockville Pike, Bethesda, MD 20892 and
National Institutes of Health, Building 31, Room B3B16, 31 Center
Drive, MSC 2012, Bethesda, MD 20892 and
National Institute of Environmental Health Sciences, Office of
Facilities Engineering, 102-01, P.O. Box 12233, Research Triangle Park,
NC 27709.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Employees of the National Institutes of Health who are issued card
keys.
CATEGORIES OF RECORDS IN THE SYSTEM:
Property management.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
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.
PURPOSE(S):
Used for card keys issuance and control.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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
[[Page 66982]]
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 (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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in file folders, and on magnetic media.
RETRIEVABILITY:
Records are retrieved by name.
SAFEGUARDS:
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.
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 HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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 three months after
the return of credentials to the issuing office. Refer to the NIH
Manual Chapter for specific instructions.
SYSTEM MANAGER(S) AND ADDRESS(ES):
For card keys: National Institutes of Health, Chief, Crime
Prevention Branch, Division of Public Safety, ORS, Building 31, Room
B3B16, 31 Center Drive, MSC 2012, Bethesda, MD 20892; or
National Institute of Environmental Health Sciences, Chief, Office
of Facilities Engineering, 102-01, P.O. Box 12233, Research Triangle
Park, NC 27709.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Write to the official specified under Notification Procedure 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).
RECORD SOURCE CATEGORIES:
Data is obtained from the individual.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
69-25-0078
SYSTEM NAME:
Administration: Consultant File, HHS/NIH/NHLBI.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institutes of Health, Westwood Building, 5333 Westbard
Avenue, Bethesda, MD 20892.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
List of consultants available for use in evaluation of National
Heart, Lung, and Blood Institute special grants and contracts.
CATEGORIES OF RECORDS IN THE SYSTEM:
Names and resumes.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 241(d), 281.
PURPOSE(S):
1. To identify and select experts and consultants for program
reviews and evaluations.
2. For use in evaluation of NHLBI special grants and contracts.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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 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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Computer disk and file folders.
RETRIEVABILITY:
Records are retrieved by name.
SAFEGUARDS:
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.
[[Page 66983]]
3. Procedural Safeguards: During regular business hours, rooms are
unlocked but are controlled by on-site personnel.
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 HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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.
SYSTEM MANAGER(S) AND ADDRESS:
Chief, Review Branch, National Heart, Lung, and Blood Institute,
Westwood Building, Room 557A, 5333 Westbard Avenue, Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Contact the official under Notification Procedure 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).
RECORD SOURCE CATEGORIES:
Subject individual.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0087
SYSTEM NAME:
Administration: Senior Staff, HHS/NIH/NIAID.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institutes of Health, Building 31, Room 7A50, 9000
Rockville Pike, Bethesda, MD 20892.
Write to system manager at the address below for the address of the
Federal Records Center where records from this system may be stored.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Current and former key professional employees of the Institute and
consultants.
CATEGORIES OF RECORDS IN THE SYSTEM:
Press releases, curricula vitae, nominations for awards, and
photographs.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 241(d), 289a.
PURPOSE(S):
For background records to provide public announcements on National
Institute of Allergy and Infectious Diseases (NIAID) research.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Stored in file folders.
RETRIEVABILITY:
Retrieved by name.
SAFEGUARDS:
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 staff whose duties
require the use of such information. Authorized users are located in
the Office of the Director, NIAID. 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 in this system are stored in file
folders which are kept in locked cabinets. The room is locked 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 employee.
RETENTION AND DISPOSAL:
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.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Office of Communications and Public Liaison, National
Institutes of Health, Building 31, Room 7A-50, 9000 Rockville Pike,
Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
To determine if a record exists, write to: National Institutes of
Health, Privacy Act Coordinator, NIAID, Solar Bldg., Room 3C-23, 6003
Executive Blvd., 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.
RECORD ACCESS PROCEDURE:
Same as record 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.
CONTESTING RECORD PROCEDURE:
Contact the system manager at the address 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).
RECORD SOURCE CATEGORIES:
Individuals and newspaper clippings.
[[Page 66984]]
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0093
SYSTEM NAME:
Administration: Authors, Reviewers, Editorial Board, and Members of
the Journal of the National Cancer Institute, HHS/NIH/NCI.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
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.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Authors and manuscript reviewers and members of the Journal of the
National Cancer Institute (JNCI) editorial board.
CATEGORIES OF RECORDS IN THE SYSTEM:
Accepted, rejected and pending manuscripts and review comments.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 241, 281.
PURPOSE(S):
Manuscript review by NCI staff of manuscripts submitted for
possible publication in the Journal of the National Cancer Institute
(JNCI) or JNCI Monographs.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in file folders.
RETRIEVABILITY:
Records are retrieved by name and manuscript number.
SAFEGUARDS:
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.
RETENTION AND DISPOSAL:
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-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 MANAGER(S) AND ADDRESS:
Systems Specialist, Scientific Publications Branch, Building 82,
Room 239, 9030 Old Georgetown Road, Bethesda, MD 20814.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Contact the official 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, with supporting justification. The right to contest
records is limited to information which is incomplete, irrelevant,
incorrect, or untimely (obsolete).
RECORD SOURCE CATEGORIES:
Authors and reviewers.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0099
SYSTEM NAME:
Clinical Research: Patient Medical Records, HHS/NIH/CC.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
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.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Registered Clinical Center patients. Some individuals not
registered as patients but seen in Clinical Center for diagnostic
tests.
CATEGORIES OF RECORDS IN THE SYSTEM:
Medical treatment records.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 241, 248: ``Research and Investigation,'' and
``Hospitals, Medical Examinations, and Medical Care.''
PURPOSE(S):
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.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
1. Information may be used to respond to Congressional inquiries
for
[[Page 66985]]
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 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
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).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in file folders and/or on microfiche, and on
computer tapes.
RETRIEVABILITY:
Records are retrieved by unit number and patient name.
SAFEGUARDS:
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 the HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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.
SYSTEM MANAGERS(S) AND ADDRESS:
Director, Medical Record Department, National Institutes of Health,
10 Center Drive, MSC 1192, Bethesda, MD 20892-1192.
NOTIFICATION PROCEDURE:
To determine if a record exists, write to the system manager at the
above address. The requester must provide tangible proof of identity,
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
[[Page 66986]]
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 as well as his/her own
identity.
RECORD ACCESS PROCEDURE:
Same as Notification Procedure. 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.
CONTESTING RECORD PROCEDURE:
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).
RECORD SOURCE CATEGORIES:
Referring physicians, other medical facilities (with patient's
consent), patients, relatives of patients.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0105
SYSTEM NAME:
Administration: Health Records of Employees, Visiting Scientists,
Fellows, and Others Who Receive Medical Care Through the Employee
Health Unit, HHS/NIH/ORS.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Buildings 10 and 13, NIH, 9000 Rockville Pike, Bethesda, MD 20892.
Rocky Mountain Laboratories, Hamilton, Montana 59840.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Employees, fellows, visiting scientists, relatives of inpatients,
visitors, and others who receive medical care through the Employee
Health Unit.
CATEGORIES OF RECORDS IN THE SYSTEM:
Medical records.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
5 U.S.C. 7901.
PURPOSE(S):
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.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in file folders.
RETRIEVABILITY:
Records are retrieved by name and social security number.
SAFEGUARDS:
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.
RETENTION AND DISPOSAL:
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.
SYSTEM MANAGER(S) AND ADDRESS:
Deputy Director, Division of Safety, NIH, Building 31, Room 1C02,
9000 Rockville Pike, Bethesda, MD 20892.
Chief, Rocky Mountain Operations Branch, Rocky Mountain
Laboratories (RML), National Institutes of Health, Hamilton, MT 59840.
NOTIFICATION PROCEDURE:
Contact system manager at appropriate treatment location listed
above, to determine if a record exists.
[[Page 66987]]
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 five thousand dollar fine.
RECORD ACCESS PROCEDURE:
Same as Notification Procedure. 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.
CONTESTING RECORD PROCEDURE:
Write to the official specified under Notification Procedure 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).
RECORD SOURCE CATEGORIES:
Records contain data resulting from clinical and preventative
services provided at treatment location, and data received from
individual.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0106
SYSTEM NAME:
Administration: Office of the NIH Director and Institute/Center
Correspondence Records, HHS/NIH/OD.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Executive Secretariat, Office of the Director, Building 1, Room B1-
55, 9000 Rockville Pike, Bethesda, MD 20892 and
Office of Legislative Policy and Analysis, Office of the Director,
Building 1, Room 244, 9000 Rockville Pike, Bethesda, MD 20892 and
Office of Science Education, Office of the Director, 6100 Executive
Blvd., Suite 5H01, Bethesda, MD 20892 and
Institute/Center 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.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Individuals who have contacted the NIH Director or his/her
subordinates, or have been contacted in writing by one of these
officials.
CATEGORIES OF RECORDS IN THE SYSTEM:
Correspondence and other supporting documents; mailing lists.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
5 U.S.C. 301; 44 U.S.C. 3101.
PURPOSE(S):
1. To control, address, 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.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored by computer index, optical image and in file
folders.
RETRIEVABILITY:
Records are retrieved by name, document number, date, and subject.
SAFEGUARDS:
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 the HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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 ten years. Refer to the NIH Manual Chapter for
specific disposition instructions.
SYSTEM MANAGER(S) AND ADDRESS
System managers are listed in Appendix I; each maintains full
responsibility for their specific correspondence system.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
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.
[[Page 66988]]
CONTESTING RECORD PROCEDURE:
Contact the official 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).
RECORD SOURCE CATEGORIES:
Records are derived from incoming and outgoing correspondence.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
Appendix I: System Managers
Assistant to the Director, Executive Secretariat, Office of the
Director, Building 1, Room B146, 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.
Privacy Act Systems Manager, Office of Science Education, 6100
Executive Blvd., Suite 5H01, 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 6A-03, 31 Center Drive, MSC 2510, Bethesda, MD 20892-2510.
National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS), Executive Officer, Building 31, Room 4C32, 31
Center Drive, MSC 2350, Bethesda, MD 20892-2350.
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 Sciences (NIGMS), Secretary to
the Director, Natcher Building, Room 2AN.12D, 45 Center Drive,
Bethesda, MD 20892.
National Library of Medicine (NLM), Secretary to the Director,
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 AIDS Research (OAR), Special Assistant for Liaison
Activities, Building 31, Room 5C12, Bethesda, MD 20892.
National Institute on Drug Abuse (NIDA), Executive Secretariat,
Neuroscience Center, 6001 Executive Blvd., Room 5101, MSC 9585,
Rockville, MD 20892-9585.
National Institute on Alcohol Abuse and Alcoholism (NIAAA),
Secretary to the Director, Willco Building, Suite 400, 6000
Executive Blvd., MSC 7003, Bethesda, MD 20892-7003.
National Institute of Mental Health (NIMH), Executive Secretariat,
Neuroscience Center, 6001 Executive Blvd., Room 8213, Rockville, MD
20852.
Washington National Records Center, 4205 Suitland Road, Washington,
DC 20857.
09-25-0108
SYSTEM NAME:
Personnel: Guest Researchers, Special Volunteers, and Scientists
Emeriti, HHS/NIH/OHRM.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
This system is located in the personnel/administrative offices of
individual Institutes/Centers of the National Institutes of Health.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Individuals using NIH facilities who are not NIH employees.
CATEGORIES OF RECORDS IN THE SYSTEM:
Personal information including name, address, date and place of
birth, education, employment, purpose for which NIH facilities are
desired, outside sponsor, and NIH sponsor.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 241(a)(2), 42 U.S.C. 282(b)(10), and 42 U.S.C.
284(b)(1)(k).
PURPOSE(S):
To determine eligibility to use NIH facilities, to document the
individual's presence at NIH, and to record that the individual is not
an employee.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
1. Disclosure may be made to U.S. Office of Personnel Management
for program evaluation purposes; to General Accounting Office for fund
disbursement determinations.
2. Disclosure may be made to institutions providing financial
support.
3. 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 request of that individual.
4. Disclosure may be made 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.
5. Records may be disclosed to student volunteers, individuals
working under a personal services contract, and other individuals
performing functions for PHS who do not technically have the status of
agency employees, if they need the records in the performance of their
agency functions.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
File folders.
RETRIEVABILITY:
Records are retrieved by name.
SAFEGUARDS:
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 granted only to personnel staff,
administrative office staff, and management officials directly involved
in the administration of the Guest Researcher, Special Volunteer, and
Scientist Emeriti programs.
2. Physical Safeguards: Record facilities are locked when system
personnel are not present.
3. Procedural Safeguards: Access to files is strictly controlled by
system personnel. Records may be removed from the file only with the
approval of the system manager or other authorized employees.
RETENTION AND DISPOSAL:
Records are retained and disposed of under the authority of the NIH
Records
[[Page 66989]]
Control Schedule contained in NIH Manual Chapter 1743, Appendix 1--
``Keeping and Destroying Records'' (HHS Records Management Manual,
Appendix B-361), item 2300-320-3(a), which allows records to be
destroyed after a maximum period of two years after the individual
completes work at NIH. Refer to the NIH Manual Chapter for specific
disposition instructions.
SYSTEM MANAGER(S) AND ADDRESS:
Personnel/Administrative Officers of National Institutes of Health
Institutes/Centers.
NOTIFICATION PROCEDURE:
To determine if a record exists and where it is located, contact:
National Institutes of Health, Office of Human Resources
Management, Privacy Act Coordinator, Building 31, Room 1C39, 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.
RECORD ACCESS PROCEDURE:
Contact the Personnel Officer or Administrative Officer in whose
office the record is located and provide verification of identity as
described under 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.
CONTESTING RECORD PROCEDURE:
Write to the official specified under Notification Procedure 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).
RECORD SOURCE CATEGORIES:
Subject individual, NIH sponsor, funding institution.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0112
SYSTEM NAME:
Grants and Cooperative Agreements: Research, Research Training,
Fellowship and Construction Applications and Related Awards, HHS/NIH/
OD.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
See Appendix I.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Grant applicants and Principal Investigators; Program Directors;
Institutional and Individual Fellows; Research Career Awardees; and
other employees of Applicant and/or grantee institutions.
CATEGORIES OF RECORDS IN THE SYSTEM:
Grant and cooperative agreement applications and review history,
awards, financial records, progress reports, payback records, and
related correspondence.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
``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 Dental and Craniofacial
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,'' ``National
Library of Medicine,'' and the ``National Center for Research
Resources'' 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, 287a-2, 287a-3.)
PURPOSE(S):
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 curricula vitae to identify candidates who
may serve as ad hoc consultants or committee and council members in the
grant peer review process.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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
[[Page 66990]]
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.
DISCLOSURE TO CONSUMER REPORTING AGENCIES:
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Stored in file folders, on computer tapes and disks, cards and in
notebooks.
RETRIEVABILITY:
Retrieved by name and grant number.
SAFEGUARDS:
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 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 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 HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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, 4000-D-1.
Refer to the NIH Manual Chapter for specific disposition instructions.
SYSTEM MANAGER(S) AND ADDRESS:
See Appendix II.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
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 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.
CONTESTING RECORD PROCEDURE:
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
[[Page 66991]]
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).
RECORD SOURCE CATEGORIES:
Information submitted by applicant; supplemented by outside
reviewers and internal staff.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
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, Extramural Programs, 6705 Rockledge
Drive, Suite 301, Bethesda, MD 20817.
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, Natcher Building, Room 5A352, Bethesda, MD 20892-6500.
National Institute of Child Health and Human Development, 6100
Executive Blvd., Room 8A-01, Bethesda, MD 20892-7510.
National Institute on Aging, Gateway Building, Room 2N-212, 7201
Wisconsin Avenue, Bethesda, MD 20892.
National Institute of Dental and Craniofacial 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 20892-7180.
National Eye Institute, Executive Plaza South, Room 350, 6120
Executive Boulevard, Bethesda, MD 20892.
National Center for Research Resources, 6705 Rockledge Drive, Room
6086, 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, 6001
Executive Blvd., Room 3131, MSC 9541, Bethesda, MD 20892-9541.
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,
Neuroscience Center, 6001 Executive Blvd., Room 6122, Bethesda, MD
20892.
Appendix II: System Manager(s) and Address(es)
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 20852.
National Library of Medicine, Associate Director for Extramural
Programs, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20817.
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, Natcher Building, Room 5AS49,
Bethesda, MD 20892-6500.
National Institute of Diabetes and Digestive and Kidney Disease,
Grants Management Officer, Room 637, Westwood Building, 5333
Westbard Avenue, Bethesda, MD 20892.
National Institute of Child Health and Human Development, Chief,
Grants Management Branch, 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 and Craniofacial Research, Grants
Management Officer, NIDCR, 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,
Chief, Grants Management Branch, Executive Plaza South, Room 400B,
MSC 7180, 6120 Executive Boulevard, Bethesda, MD 20892-7180.
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, Office of Grants Management,
6705 Rockledge Drive, Room 6086, 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, 6001 Executive Blvd., Room 3131,
MSC 9541, Bethesda, MD 20892-9541.
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,
Neuroscience Center, 6001 Executive Blvd., Room 6122, Bethesda, MD
20892.
Appendix III: Notification Procedure
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 and Craniofacial Research (NIDCR),
Privacy Act Coordinator, Natcher Building, Room 4AS-43A, 45 Center
Drive, MSC 6401, Bethesda, MD 20892-6401.
National Institute of Environmental Health Sciences, see Appendix
II.
National Institute of General Medical Sciences, see Appendix II.
[[Page 66992]]
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.
National Institute of Arthritis and Musculoskeletal and Skin
Diseases, see Appendix II.
Appendix IV: Records Access Procedure
National 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 and Craniofacial Research (NIDCR),
Grants Management Officer, Natcher Building, Room 4AS-55, 45 Center
Drive, MSC 6402, Bethesda, MD 20892-6402.
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,
Grants Management Branch, Executive Plaza South, Room 400B, 6120
Executive Blvd., Rockville, MD 20892-7180.
National Institute on Deafness and Other Communication Disorders,
see Appendix II.
National Eye Institute, Administrative Officer, Building 31, Room
6A17, 9000 Rockville Pike, Bethesda, MD 20892.
National Center for Research Resources, Privacy Act Coordinator,
6705 Rockledge Drive, Room 5142, 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.
National Institute of Arthritis and Musculoskeletal and Skin
Diseases, see Appendix II.
09-25-0115
SYSTEM NAME:
Administration: Curricula Vitae of Consultants and Clinical
Investigators, HHS/NIH/NIAID.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institutes of Health, Solar Bldg., 6003 Executive Blvd.,
Room 3A37, MSC 7630, Bethesda, MD 20892 and
McKesson BioServices Corporation, 7501 Standish Place, Rockville,
MD 20850.
Write to the system manager at the address below for the address of
the Federal Records Center where records are stored.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Consultants and Clinical Investigators under National Institute of
Allergy and Infectious Diseases (NIAID) Investigational New Drug
Applications.
CATEGORIES OF RECORDS IN THE SYSTEM:
Curricula vitae.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 241, 289a.
PURPOSE(S):
1. To maintain a record of the investigators under Investigational
New Drug (IND) applications.
2. To appoint consultants to the NIAID Institutional Review Board
(IRB).
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Stored in books.
RETRIEVABILITY:
Retrieved by name.
SAFEGUARDS:
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 NIAID staff whose duties
require the use of such information. Authorized users are located in
the Clinical and Regulatory Affairs Branch, Division of Microbiology
and Infectious Diseases, NIAID. 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: Building is locked 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 employee.
RETENTION AND DISPOSAL:
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.
SYSTEM MANAGER(S) AND ADDRESS:
Chief, Clinical and Regulatory Affairs Branch, DMID, NIAID, Solar
Bldg., Room 3A-01, 6003 Executive Blvd., Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
To determine if a record exists, write to: NIAID Privacy Act
Coordinator,
[[Page 66993]]
Solar Bldg., Room 3C-23, 6003 Executive Blvd., 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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Write to the official specified under Notification Procedure 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).
RECORD SOURCE CATEGORIES:
Individuals.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0118
SYSTEM NAME:
Contracts: Professional Services Contractors, HHS/NIH/NCI.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Write to system manager at the address below for the address of the
Federal Records Center where records may be stored.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Individuals under contract with the National Cancer Institute.
CATEGORIES OF RECORDS IN THE SYSTEM:
Professional services contracts.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 241(d), 281.
PURPOSE(S):
Used by staff for general administrative purposes to assure
compliance with contract program requirements.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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 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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Stored in file folders.
RETRIEVABILITY:
Retrieved by name.
SAFEGUARDS:
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.
RETENTION AND DISPOSAL:
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 six years and three months after final
payment. Refer to the NIH Manual Chapter for specific disposition
instructions.
SYSTEM MANAGER(S) AND ADDRESS:
ARC Manager, NCI/DCTD, Building 31, Room 3A44, 9000 Rockville Pike,
Bethesda, MD 20892.
ARC Manager, NCI/OD-31, Building 31, Room 11A33, 9000 Rockville
Pike, Bethesda, MD 20892.
ARC Manager, NCI/OD-EP, Executive Plaza South, Room 531, 6120
Executive Blvd., Rockville, MD 20852.
ARC Manager, NCI/6116, Executive Plaza South, Room 531, 6120
Executive Blvd., Rockville, MD 20852.
ARC Manager, NCI/DCP, Building 31, Room 10A50, 9000 Rockville Pike,
Bethesda, MD 20892.
ARC Manager, NCI/DCB, Executive Plaza North, Room 500, 6130
Executive Blvd., Rockville, MD 20852.
ARC Manager, NCI/DCCPS, Executive Plaza North, Room 306, 6130
Executive Blvd., Rockville, MD 20852.
ARC Manager, NCI/Bldg. 41, Building 41, Room A101, 9000 Rockville
Pike, Bethesda, MD 20892.
ARC Manager, NCI/Bldg. 37, Building 37, Room 5A15, 9000 Rockville
Pike, Bethesda, MD 20892.
ARC Manager, NCI/FCRDC, FCRDC, Building 428, Room 43, Frederick, MD
21702.
ARC Manager, NCI/DCEG, Executive Plaza South, Room 8086, 6120
Executive Blvd., Rockville, MD 20852.
ARC Manager, NCI/31-DBS, Building 31, Room 3A20, 9000 Rockville
Pike, Bethesda, MD 20892.
ARC Manager, NCI/31-DCS, Building 31, Room 3A11, 9000 Rockville
Pike, Bethesda, MD 20892.
ARC Manager, NCI/10A, Building 10, Room 12N210, 9000 Rockville
Pike, Bethesda, MD 20892.
ARC Manager, NCI/10B, Building 10, Room 12N210, 9000 Rockville
Pike, Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Contact the official under Notification Procedure above, and
reasonably
[[Page 66994]]
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).
RECORD SOURCE CATEGORIES:
Individuals in the system.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0121
SYSTEM NAME:
International Activities: Senior International Fellowships Program,
HHS/NIH/FIC.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institutes of Health, Building 31, Room B2C39, 9000
Rockville Pike, Bethesda, MD 20892.
Write to system manager at the address below for the address of the
Federal Records Center where records from this system are stored.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Applicants for Senior International Fellowships.
CATEGORIES OF RECORDS IN THE SYSTEM:
Applications and associated records and reports.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 242e.
PURPOSE(S):
For award and administration of fellowships to outstanding faculty
members in mid-career from U.S. biomedical research and educational
institutions for study abroad.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
1. Each fellow's home institution receives a notice of award and
funding for the fellowship.
2. Applications are made available to authorized employees and
agents of the U.S., including the General Accounting Office for
purposes of investigations, inspections and audits, and in appropriate
cases, to the Department of Justice for proper action under civil and
criminal laws.
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 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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
File folders and computer disks.
RETRIEVABILITY:
Name and fellowship number.
SAFEGUARDS:
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 Fogarty International
Center (FIC) program 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: The records are stored in locked file
cabinets and offices are locked 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 to
authorized users and 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 the HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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 2300-320-7, which allows records to be destroyed
after a maximum period of six years after the close of a case. Refer to
the NIH Manual Chapter for specific disposition instructions.
SYSTEM MANAGER(S) AND ADDRESS:
Chief, International Research Awards Branch, Fogarty International
Center, National Institutes of Health, Building 31, Room B2C39, 9000
Rockville Pike, Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
Requests for notification of or access to records should be
addressed 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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Contact the official 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).
RECORD SOURCE CATEGORIES:
Information obtained from applicants and persons supplying
[[Page 66995]]
recommendations through the Center for Scientific Review.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0124
SYSTEM NAME:
Administration: Pharmacology Research Associates, HHS/NIH/NIGMS.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institutes of Health, Director, PRAT Program,
Pharmacological Sciences, NIGMS, Natcher Building, Room 2AS.43D, 9000
Rockville Pike, Bethesda, MD 20892.
Write to system manager at the address below for the address of the
Federal Records Center where records are stored.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Applicants for positions as Pharmacology Research Associates with
the National Institute of General Medical Sciences (NIGMS) and current
and former Pharmacology Research Associates.
CATEGORIES OF RECORDS IN THE SYSTEM:
Individual application forms, addresses, telephone numbers, lists
of awards received, research keywords, preceptor and institute during
time of fellowship for former fellows, academic transcripts, reprints
and references, curricula vitae, and salary adjustment memorandum for
fellows.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 209.
PURPOSE(S):
For review, award and administration of the Pharmacology Research
Associate Program (PRAT).
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
File folders.
RETRIEVABILITY:
By name of applicant.
SAFEGUARDS:
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 the system are
instructed to grant access only to authorized personnel (system manager
and staff assigned to the program).
2. Physical Safeguards: The records are maintained in locked file
cabinets when not in use and system location is locked during non-
working hours.
3. Procedural Safeguards: Access to files is strictly controlled by
responsible individuals who have been instructed in the Privacy Act
requirements. Records are returned to the locked cabinets when not in
use.
RETENTION AND DISPOSAL:
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 2300-320-2(a). Refer to the NIH Manual Chapter
for specific disposition instructions.
SYSTEM MANAGER(S) AND ADDRESS:
Director, PRAT Program, Pharmacological Sciences, NIGMS, Natcher
Building, Room 2AS.49K, 9000 Rockville Pike, Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
To determine if a record exists, write to system manager and
provide the following information: Applicant's name and date of
application. 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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Contact the official at the address specified under Notification
Procedure above, and reasonably identify the record and specify the
information to be contested, the corrective action sought. The right to
contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
RECORD SOURCE CATEGORIES:
Information obtained from applicants, university registrars, and
persons supplying recommendations through the PRAT Program. Salary
adjustment memos from preceptors. Information on former fellows
obtained from former fellows.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0140
SYSTEM NAME:
International Activities: International Scientific Researchers in
Intramural Laboratories at the National Institutes of Health, HHS/NIH/
FIC.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Fogarty International Center, Building 16A, Room 101, 9000
Rockville Pike, Bethesda, MD 20892, and
Center for Information Technology, Building 12A, Room 3061,
National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland
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.
[[Page 66996]]
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Health scientists at all levels of their pre- and postdoctoral or
equivalent research careers who are invited to the National Institutes
of Health to conduct research related to their doctoral studies, for
further postdoctoral 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.
Individuals in these categories include the following: Visiting
Scientists (i.e., Title 42 employees) and Foreign Special Experts (also
employees) and Visiting Fellows, Guest Researchers, Exchange
Scientists, International Research Fellows, Fogarty Scholars, and
Special Volunteers.
CATEGORIES OF RECORDS IN THE SYSTEM:
History of fellowship, employment and/or stay at NIH; education,
previous institution of affiliation, immigration data, and references.
For payroll purposes, social security numbers are requested of all
applicants accepted into the program.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 242l and Section 307 of the Public Health Service Act.
PURPOSE(S):
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'').
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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, the FBI and
Immigration and Naturalization Service, Department of Justice, and the
Department of State for purposes of investigations, inspections and
audits.
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 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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in file folders, computer hard disks and tapes,
and computer diskettes.
RETRIEVABILITY:
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.
SAFEGUARDS:
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 locked 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 the HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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 six years after the close of a case. Refer to
the NIH Manual Chapter for specific disposition instructions.
SYSTEM MANAGER(S) AND ADDRESS:
Chief, International Services Branch, National Institutes of
Health, Fogarty International Center, Building 16A, Room 101, 16A
Center Drive, MSC 6710, Bethesda, MD 20892-6710.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
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).
RECORD SOURCE CATEGORIES:
Subject individuals and other Federal agencies.
[[Page 66997]]
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0156
SYSTEM NAME:
Records of Participants in Programs and Respondents in Surveys Used
to Evaluate Programs of the Public Health Service, HHS/PHS/NIH/OD.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
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 Service (PHS) facilities,
or facilities of contractors of the PHS. Write to the appropriate
system manager below for a list of current locations.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
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.
CATEGORIES OF RECORDS IN THE SYSTEM:
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 MAINTENANCE OF 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.
PURPOSE(S):
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.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Data may be stored in file folders, bound notebooks, or computer-
accessible media (e.g., magnetic tapes, disks, cartridges, CD-ROMs,
etc.).
RETRIEVABILITY:
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.
SAFEGUARDS:
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.
[[Page 66998]]
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 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 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, CD-ROMs, etc.) 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 the HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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.
SYSTEM MANAGER(S) AND ADDRESS:
See Appendix I.
Policy coordination for this system is provided by: Acting
Director, Office of Reports and Analysis, Office of Extramural
Research, Office of the Director, National Institutes of Health, Bldg.
1, Room 252, 9000 Rockville Pike, Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
To determine if a record exists, write to the official of the
organization responsible for the evaluation, as listed in Appendix II.
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, 6011
Executive Blvd., Room 601L, MSC 7669, Rockville, MD 20852.
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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Write to the official specified under Notification Procedure 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).
RECORD SOURCE CATEGORIES:
Information contained in these records is obtained directly from
individual participants; from systems of records 09-25-0036,
``Extramural Awards and Chartered Advisory Committees: IMPAC (Grants/
Contract Information/Cooperative Agreement Information/Chartered
Advisory Committee Information), HHS/NIH/OER and HHS/NIH/CMO;'' 09-25-
0112, ``Grants and Cooperative Agreements: Research, Research Training,
Fellowship and Construction Applications and Related 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.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
Appendix I: System Managers
Office of Reports and Analysis, Office of Extramural Research,
Office of the Director, National Institutes of Health, RKL2, 6701
Rockledge Drive, Room 6212, 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), NHLBI Minority
Coordinator, OD, OPPE, Building 31, Room 5A03/5A06, 31 Center Drive,
MSC 2482, Bethesda, MD 20892-2482.
[[Page 66999]]
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 10A03, 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 Child Health and Human Development (NICHD),
Associate Director for Science Policy, Analysis, and Communication,
Building 31, Room 2A18, Bethesda, MD 20892.
National Institute on Deafness and Other Communication Disorders,
Chief, Program Planning and Health Reports Branch, Building 31, Room
3C35, 9000 Rockville Pike, Bethesda, MD 20892.
National Institute of Dental and Craniofacial Research (NIDCR),
Evaluation Officer, Office of Science Policy and Analysis, Building
31, Room 5B55, 31 Center Drive, MSC 2190, Bethesda, MD 20892-2190.
National Institute of Environmental Health Sciences (NIEHS), Program
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
2AS-55F, 9000 Rockville Pike, Bethesda, MD 20892.
Fogarty International Center (FIC), National Institutes of Health,
Assistant Director for International Science Policy and Analysis,
Building 31, Room B2C08, Bethesda, MD 20892.
Center for Scientific Review (CSR), Information Officer, Rockledge
Centre II, Room 6160, 6701 Rockledge Drive, Bethesda, MD 20817.
National Center for Research Resources (NCRR), Director, Office of
Science Policy, Rockledge Building, Room 5046, 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, Rockwall-II Building, Rockville, MD 20852.
Appendix II: Notification and Access Officials
NIH, Office of the Director, Office of Extramural Research, Acting
Director, Office of Reports and Analysis, Building 1, Room 252, 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), 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 International Science Policy and Analysis,
Building 31, Room B2C08, Bethesda, MD 20892.
Center for Scientific Review (CSR), Information Officer, Rockledge
Centre II, Room 6160, 6701 Rockledge Drive, Bethesda, MD 20817.
National Center for Research Resources (NCRR), Director, Office of
Science Policy, Rockledge Bldg., Room 5046, Bethesda, MD 20892.
National Cancer Institute, Privacy Act Coordinator, National
Institutes of Health, Building 31, Room 10A30, Bethesda, MD 20892.
09-25-0158
SYSTEM NAME:
Administration: Records of Applicants and Awardees of the NIH
Intramural Research Training Awards Program, HHS/NIH/OD.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
This system is located in each of the intramural offices and
laboratories where the Intramural Research Training Awards (IRTA)
Fellow is located and assigned, including the respective Scientific
Director's office, the administrative and personnel offices, and in
Division of Personnel Management branches responsible for administering
the IRTA Program, and the Office of Education, Building 10, Room 1C125,
9000 Rockville Pike, Bethesda, MD 20892.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Applicants for IRTA Fellowships, current IRTA Fellows, and former
IRTA Fellows.
CATEGORIES OF RECORDS IN THE SYSTEM:
These records contain information relating to education and
training, employment history, scientific publications; research goals;
letters of reference; and personal information such as name, date of
birth, social security number, home address and citizenship; and
information related to fellowship awards such as stipend levels,
training assignments, training expenses and travel allowances.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 284(b)(1)(C), 286b-3, and 287c-1 authorizes PHS to make
awards for biomedical research and research training.
PURPOSE(S):
Records in this system are used to determine individuals'
eligibility and evaluate their qualifications for IRTA Fellowships; to
document the basis for management actions relating to Fellowships that
are awarded; and to provide data for program evaluation.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
1. Disclosure may be made to the Office of Personnel Management for
evaluation of NIH Personnel programs.
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 written 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
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.
4. Disclosure may be made to a Federal, State or local agency
maintaining civil, criminal or other pertinent records, such as current
licenses, if necessary to obtain a record relevant to an agency
decision concerning the selection or retention of a fellow.
5. Disclosure may be made to a Federal agency, in response to its
request, in connection with hiring or
[[Page 67000]]
retention of an employee, the issuance of a security clearance, an
investigation of an employee, 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.
Records may be disclosed to student volunteers, individuals working
under a personal services contract, and other individuals performing
functions for PHS who do not technically have the status of agency
employees, if they need the records in the performance of their agency
functions.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in file folders, and on magnetic tapes and
disks.
RETRIEVABILITY:
Records are retrieved by name, social security number, or institute
list number.
SAFEGUARDS:
1. Authorized Users: Access is granted only to NIH scientists,
administrative office staff, personnel staff, and financial management
staff directly involved in the administration of the IRTA Program.
2. Physical Safeguards: File folders are kept in locked drawers or
locked rooms when system personnel are not present.
3. Procedural Safeguards: Access to file folders is controlled by
system personnel. Records may be removed from the files only with the
approval of the system manager or other authorized employees. Data
stored in the automated system is accessed through the use of keywords
known only to authorized personnel.
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 HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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-E-3. Refer to the NIH Manual Chapter for
specific disposition instructions.
SYSTEM MANAGER(S) AND ADDRESS:
Personnel/Administrative Officers of the National Institutes of
Health Institutes/Centers. Contact the individual listed under
Notification Procedure for the name and address of the appropriate
system manager.
NOTIFICATION PROCEDURE:
To determine if a record exists and where it is located, contact:
Chief, Staffing Management Branch, Division of Personnel Management,
NIH, Building 31, Room 1C31, 9000 Rockville Pike, Bethesda, MD 20892.
The requestor 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.
RECORDS ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Write to the official specified under the Notification Procedure
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 untimely, incomplete, irrelevant or inaccurate. The
right to contest records is limited to information which is incomplete,
irrelevant, incorrect, or untimely (obsolete).
RECORD SOURCE CATEGORIES:
Applicants, persons and institutions supplying references.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0160
SYSTEM NAME:
United States Renal Data System (USRDS), HHS/NIH/NIDDK.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Records are located at contractor operated coordinating center.
Write to the system manager at address below for address of current
location. U.S. Renal Data System, Coordinating Center (CC), 2100 M
Street NW, Suite 400, Washington, DC 20037.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Persons with end-stage renal disease (ESRD), providers of ESRD
services.
CATEGORIES OF RECORDS IN THE SYSTEM:
Health and medical record data; fiscal information; patient names,
social security number, Health Care Financing Administration (HCFA)
beneficiary ID, patient demographic, epidemiologic and survival
characteristics; physician provider characteristics; facility provider
characteristics.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 241a, 289c, as last amended by Pub. L. 100-607, November
4, 1988 under the Health Omnibus Programs Extension of 1988.
PURPOSE(S):
1. To design and implement a consolidated renal disease system that
will provide the biostatistical, data management and analytical
expertise necessary to characterize the total renal patient population
and describe the distribution of patients by sociodemographic variables
across treatment modalities.
2. To report on the incidence, prevalence, and mortality rates of
renal disease by primary diagnosis.
3. To identify the modalities of treatment best suited to
individual patients. To compare the various treatment alternatives to
examine the prevention and progression of renal disease by morbidity,
mortality, and quality of life criteria.
4. To identify problems and opportunities for more focused
investigations of renal research issues currently unaddressed by the
consolidated data system.
5. To share data with other PHS agencies and HCFA for their use in
research analysis and program administration.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
1. Disclosure from the record of an individual may be made 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 official
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
[[Page 67001]]
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, the 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.
2. Disclosure may be made to a Congressional office from the record
of an individual in response to a written inquiry from the
Congressional office made at the written request of the individual.
3. Disclosure may be made to the HHS contractor for the purpose of
collating, analyzing, aggregating or otherwise refining or processing
records in this system for developing, modifying and/or manipulating
ADP software. Data would also be disclosed to contractors incidental to
consultation, programming, operation, user assistance, or maintenance
for an ADP or telecommunications systems containing or supporting
records in the system. The contractor shall be required to 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 recipients understanding of, and willingness
to abide by these provisions.
Records may be disclosed to student volunteers, individuals working
under a personal services contract, and other individuals performing
functions for PHS who do not technically have the status of agency
employees, if they need the records in the performance of their agency
functions.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Electronic medium; selected hard copy backup.
RETRIEVABILITY:
Information will be retrieved by patient identification number such
as social security number and HCFA beneficiary ID. Individual patient
data provided only as noted above. Statistical data provided as noted
above and to the general public as part of periodic published reports.
SAFEGUARDS:
A variety of safeguards are implemented for the various sets of
records in this system according to the sensitivity of the records:
1. Authorized Users: Regular access is limited to National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), HCFA
and contract personnel who have a need for the data in performance of
their duties as determined by the system manager.
2. Physical Safeguards: Records are stored in areas where access is
restricted to areas where data are maintained and processed; data tapes
and hard copy data are stored in locked files in secured areas;
terminal access controlled by user ID and keywords; off-site data
backups in two locations--a remote area of the same building and a
separate building; and fire protection secured by Halon fire
extinguisher system and fire alarm system present in the computer room.
3. Procedural Safeguards: 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.
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 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 HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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.
SYSTEM MANAGER(S) AND ADDRESS:
Epidemiology Program Director, National Institute of Diabetes and
Digestive and Kidney Diseases, Division of Kidney, Urologic and
Hematologic Diseases, 5333 Westbard Avenue, Westwood Building, Room
621, Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
To determine if a record exists, write to the system manager at the
address noted above. Provide notarized signature as proof of identity.
The request should include as much of the following information as
possible: (a) Full name; (b) title of project individual participated
in; and (c) approximate dates of participation.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Contact the system manager at the address specified under
Notification Procedure 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. The right to contest
records is limited to information which is incomplete, irrelevant,
incorrect, or untimely (obsolete).
[[Page 67002]]
RECORD SOURCE CATEGORIES:
The majority of health, medical, fiscal and other demographic
information on patients and health care providers is from the end stage
renal disease program of the Health Care Financing Administration
(HCFA). Additional data comes from other HCFA Medicare patient records,
the National Death Index, and other sources of non-Medicare ESRD
patient records such as the NIH Continuous Ambulatory Peritoneal
Dialysis (CAPD) Registry, the United Network of Organ Sharing (UNOS)
transplant patients, the Veteran's Administration, and the Indian
Health Service.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0161
SYSTEM NAME:
Administration: NIH Consultant File, HHS/NIH/CSR.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
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.
Center for Information Technology, Data Management Branch, Building
12A, Room 4041B, National Institutes of Health, Bethesda, MD 20892.
Write to the appropriate system manager listed in Appendix I for a
list of current locations.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
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.
CATEGORIES OF RECORDS IN THE SYSTEM:
Names, addresses, social security numbers, resumes, curricula vitae
(C.V.s), areas of expertise, gender, minority status, business status,
AREA-eligible status, publications, travel records, and payment records
for consultants.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Section 301 of the Public Health Service Act, describing the
general 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 290aa).
PURPOSE(S):
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; (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.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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, collation,
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records may be stored in file folders, computer tapes and disks,
microfiche, and microfilm.
RETRIEVABILITY:
Records are retrieved by name, expertise, gender, minority status,
business status, AREA-eligible status and experimental system used.
SAFEGUARDS:
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: 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.
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.
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 HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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.
[[Page 67003]]
SYSTEM MANAGER(S) AND ADDRESS:
The policy coordinator for this system is also the system manager
listed for the Center for Scientific Review (CSR).
Chief, Biochemical Sciences Initial Review Group, Division of
Molecular and Cellular Mechanisms, Center for Scientific Review,
Rockledge Centre II, Room 5150, 6701 Rockledge Drive, Bethesda,
Maryland 20817 and
See Appendix I.
NOTIFICATION PROCEDURE:
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 whom he or she claims to be. The request should
include: (a) full name, and (b) appropriate dates of participation.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
Contact the official under Notification Procedure 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).
RECORD SOURCE CATEGORIES:
Subject individual.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
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, 6705 Rockledge Drive, Room 6018, Bethesda, MD 20892.
National Cancer Institute (NCI), Chief, Applied Information Systems
Branch, Executive Plaza North, Room 643, 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 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 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 400C, 6120 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 and Craniofacial Research (NIDCR),
Chief, Scientific Review Section, Natcher Building, Room 4AN-44F, 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, PO 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), Extramural Programs, Scientific
Review Administrator, 6705 Rockledge Drive, Bethesda, MD 20817.
National Center for Human Genome Research (NCHGR), Chief, Office of
Scientific Review, Building 38A, Room 604, Bethesda, MD 20892.
National Institute of Mental Health, Committee Management Officer,
Division of Extramural Activities, 6100 Executive Blvd., Room 6133,
Bethesda, MD 20892.
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, Neuroscience Center, 6001 Executive Blvd., Room 3158,
Bethesda, MD 20892.
09-25-0165
SYSTEM NAME:
National Institutes of Health Loan Repayment Program, HHS/NIH/OD.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Loan Repayment Program (LRP), Office of the Director, National
Institutes of Health, Federal Building, Room 102, 7550 Wisconsin
Avenue, Bethesda, MD 20892-9015.
Center for Information Technology (CIT), National Institutes of
Health, Building 12A, Room 4037, 9000 Rockville Pike, Bethesda,
Maryland 20892.
Office of Financial Management (OFM), 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.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
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.
CATEGORIES OF RECORDS IN THE SYSTEM:
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.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
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
[[Page 67004]]
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 social security number for the receipt of loan
repayment funds under the NIH LRP.
PURPOSE(S):
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.
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.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USE:
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. 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,
[[Page 67005]]
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.
DISCLOSURE TO CONSUMER REPORTING AGENCIES:
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 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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are maintained in file folders, computer tape, disks, and
file cards.
RETRIEVABILITY:
Records are retrieved by name, social security number, or other
identifying numbers.
SAFEGUARDS:
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,
and the HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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 ten 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.
SYSTEM MANAGER(S) AND ADDRESS:
Director, NIH Loan Repayment Program, Office of the Director,
National Institutes of Health, Federal Building, Room 102, 7550
Wisconsin Avenue, Bethesda, MD 20892-9015
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
Write to the system manager specified above to attain access to
records and provide the same information as is required under the
Notification Procedure. Requesters should also reasonably specify the
record contents being sought. Individuals may also request an
accounting of disclosure of their records, if any.
CONTESTING RECORD PROCEDURE:
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).
RECORD SOURCE CATEGORIES:
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.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[[Page 67006]]
Appendix I: System Locations
Loan Repayment Program, National Institutes of Health, Federal
Building, Room 102, 7550 Wisconsin Avenue, Bethesda, MD 20892-9015.
Center for Information 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
20892.
National Institute of Dental and Craniofacial 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
Institutes 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 Institutes 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.
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 Institutes 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, 5600 Fishers Lane, Rockville, MD
20857.
Clinical Center Nursing Recruitment Office, National Institutes of
Health, Building 10, Room 2C206, 9000 Rockville Pike, Bethesda, MD
20892.
09-25-0166
SYSTEM NAME:
Administration: Radiation and Occupational Safety and Health
Management Information Systems, HHS/NIH/ORS.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
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.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
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.
CATEGORIES OF RECORDS IN THE SYSTEM:
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.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
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.
PURPOSE(S):
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.
[[Page 67007]]
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USE:
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: (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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
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.
RETRIEVABILITY:
Records are retrieved by name, social security number, office
address, or unique RSB or OSHB assigned identification number.
SAFEGUARDS:
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, ``Safeguarding Records
Contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13,
and the HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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.
SYSTEM MANAGER(S) AND ADDRESS:
Assistant Chief, Information Technology, Radiation Safety Branch,
DS, ORS, Building 21, Room 134, 9000 Rockville Pike, Bethesda, Maryland
20892.
[[Page 67008]]
Chief, Occupational Safety and Health Branch, Division of Safety,
National Institutes of Health, Building 13, Room 3K04, 9000 Rockville
Pike, Bethesda, Maryland 20892.
NOTIFICATION PROCEDURE:
To determine if a record exists, write to the appropriate system
manager as 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 whom he or she claims to be. The request should
include: (a) Full name, and (b) appropriate dates of participation.
RECORD ACCESS PROCEDURE:
Same as Notification Procedure. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
an accounting of disclosure of their records, if any.
CONTESTING RECORD PROCEDURE:
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).
RECORD SOURCE CATEGORIES:
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.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0167
SYSTEM NAME:
National Institutes of Health (NIH) TRANSHARE Program, HHS/NIH/OD.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Employee Transportation Services Office (ETSO), National Institutes
of Health, Building 31, Room B3B08, 9000 Rockville Pike, Bethesda, MD
20892.
Recreation and Welfare Association Activities Desk, National
Institutes of Health, Building 31, Room B1W30A, 9000 Rockville Pike,
Bethesda, MD 20892.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
NIH employees who apply for and participate in the NIH TRANSHARE
Program.
CATEGORIES OF RECORDS IN THE SYSTEM:
Name, home address, parking hanger permit number, unique computer
identification number, NIH TRANSHARE commuter card number, NIH pay
plan, grade level, office phone number, building and room, Institute/
Center designation, name of supervisor, commute mode to work, and type
of fare media used.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Section 629 of Pub. L. 101-509, ``State or Local Government
Programs Encouraging Employee Use of Public Transportation; Federal
Agency Participation,'' found at 5 U.S.C. note prec. section 7901.
PURPOSE(S):
1. To manage the NIH TRANSHARE Program, including receipt and
processing of employee applications, and coordination of the fare media
distribution to employees.
2. To monitor the use of appropriated funds used to support the NIH
TRANSHARE Program.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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, 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. NIH may disclose applicant's name, unique computer
identification number, NIH TRANSHARE commuter card number, and type of
participant's fare media to be disbursed to cashiers of the Recreation
and Welfare Association of the National Institutes of Health, Inc. (R&W
Association) who are responsible for distribution of fare media.
Cashiers are required to maintain Privacy Act safeguards with respect
to such records.
4. Disclosure may be made to organizations deemed qualified by the
Secretary to carry out quality assessments or utilization review.
5. NIH may disclose statistical reports containing information from
this system of records to city, county, State, and Federal Government
agencies (including the General Accounting Office).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are maintained in file folders and computer disks.
RETRIEVABILITY:
Records are retrieved by name and NIH TRANSHARE commuter card
number.
SAFEGUARDS:
1. Authorized Users: Data on computer files is accessed by keyword
known only to authorized users who are ETSO employees and cashiers of
the R&W Association who are responsible for implementing the Program.
Cashier access will be limited to applicant's name, unique computer
identification number, NIH TRANSHARE computer card number, and type of
fare media disbursed. 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.
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,
and the HHS Automated Information Systems Security Program Handbook.
[[Page 67009]]
RETENTION AND DISPOSAL:
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 1500-A-3. Records are retained for a maximum of
two years following the last month of an employee's participation in
the NIH TRANSHARE Program. Paper copies are destroyed by shredding.
Computer files are destroyed by deleting the record from the file.
SYSTEM MANAGER(S) AND ADDRESS:
Traffic Management Specialist, Employee Transportation Service
Officer, Division of Security Operations, National Institutes of
Health, Building 31, Room B3B08, 9000 Rockville Pike, Bethesda, MD
20892.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
Write to the system manager specified above to attain access to
records and provide the same information as is required under the
Notification Procedure. Requesters should also reasonably specify the
record contents being sought. Individuals may also request an
accounting of disclosure of their records, if any.
CONTESTING RECORD PROCEDURE:
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).
RECORD SOURCE CATEGORIES:
Subject individual.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0168
SYSTEM NAME:
Invention, Patent, and Licensing Documents Submitted to the Public
Health Service by its Employees, Grantees, Fellowship Recipients, and
Contractors, HHS/PHS/FDA/NIH/OTT.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Office of Technology Transfer, National Institutes of Health, 6011
Executive Boulevard, Third Floor, Room 325, Rockville, MD 20852.
Office of Financial Management (OFM), National Institutes of
Health, Building 31, Room B1B55, 9000 Rockville Pike, Bethesda,
Maryland 20892.
Office of Reports and Analysis, Office of Extramural Research,
National Institutes of Health, Building 1, Room 252, 1 Center Drive,
Bethesda, MD 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.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
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.
CATEGORIES OF RECORDS IN THE SYSTEM:
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,
Case/Serial 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.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
35 U.S.C. 200 and 15 U.S.C. 3710 provide authority to maintain the
records; 37 CFR part 401 ``Rights to Inventions Made by Nonprofit
Organizations and Small Business Firms under Government Grants,
Contracts, and Cooperative Agreements;'' 37 CFR part 404 ``Licensing of
Government Owned Inventions;'' and 45 CFR part 7 ``Employee
Inventions.''
PURPOSE(S):
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, non-government
contractors, and nonprofit and educational institutions.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USE:
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
[[Page 67010]]
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
The records will be stored in file folders, computer tapes and
computer disks.
RETRIEVABILITY:
Records are retrieved by name of the inventor, EIR number, or
keywords relating to the nature of the invention, Case/Serial Number,
Licensing Number, internal reference numbers, contractor, agency,
Institute, and/or Center.
SAFEGUARDS:
1. Authorized Users: Data on computer files is accessed by password
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 dedicated file room
or in locking file cabinets in file folders. During normal business
hours, OTT Records Management on-site contractor 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 passwords known only to the
authorized users. A password is required to access the database. 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,
and the HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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 thirty years. Refer to the NIH Manual Chapter for specific
disposition instructions.
SYSTEM MANAGER(S) AND ADDRESS
Acting Director for Administrative Services, Office of Technology
Transfer, National Institutes of Health, 6011 Executive Boulevard,
Third Floor, Room 325, Rockville, Maryland 20852.
Office of Reports and Analysis, Office of Extramural Research,
National Institutes of Health, Building 1, Room 252, 1 Center Drive,
Bethesda, MD 20892-2184.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
Write to the system manager specified above to attain access to
records and provide the same information as is required under the
Notification Procedure. Requesters should also reasonably specify the
record contents being sought. Individuals may also request an
accounting of disclosure of their records, if any.
CONTESTING RECORD PROCEDURE:
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).
RECORD SOURCE CATEGORIES:
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; United States and foreign
patent offices; prospective licensees; PHS Technology Development
Coordinators, Internet and commercial databases, and third parties whom
PHS contacts to determine individual invention ownership or Government
ownership.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0169
SYSTEM NAME:
Medical Staff-Credentials Files, HHS/NIH/CC.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Medical Record Department, National Institutes of Health, 10 Center
Drive, MSC 1192, Bethesda, MD 20892-1192.
Write to the system manager at the address below for a list of
Contractor locations, including the address of any
[[Page 67011]]
Federal Records Center where records from this system may be stored.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Individuals who have been approved as members of the medical staff
at the Warren G. Magnuson Clinical Center.
CATEGORIES OF RECORDS IN THE SYSTEM:
Medical staff names, date of birth, home address and telephone
number, office address and telephone number, citizenship, visa
information, appointment date, hospital-wide computer access
privileges, Institute/Center designation, branch/lab, type of medical
staff membership, privilege delineation, professional degree(s)
including school of attendance and graduation dates, foreign medical
examinations, specialty board certifications, licensing information
(including state of licensure and license number), record of
disciplinary actions, documentation of training, and admitting
privileges.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The authority for collecting the requested information is contained
in section 301 (42 U.S.C. 241) of the Public Health Service Act, as
amended, outlining the authority of the Secretary to, within the Public
Health Service (PHS), promote the coordination of various research and
associated activities, including for purposes of study, admitting and
treating individuals at PHS facilities. Section 402(b) of the Public
Health Service Act (42 U.S.C. 282(b)), as amended, outlining the
authority of the Director of the National Institutes of Health (NIH)
with respect to the admission and treatment of individuals at NIH
facilities for purposes of study.
PURPOSE(S):
These records are used to: (1) Maintain information used in the
credentialing and privileging of active medical staff members at the
Warren G. Magnuson Clinical Center; (2) document patient care
privileges for active members of the medical staff; (3) provide
information about active and non-active members of the medical staff to
authorized individuals; and (4) report to the National Practitioner
Data Bank as required by the provisions of Title IV of Pub. L. 99-660,
as amended.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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, 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. 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 to representatives of the Joint
Commission on Accreditation of Healthcare Organizations for the purpose
of conducting quality assurance reviews and inspections of the Warren
G. Magnuson Clinical Center credentialing policies and procedures.
6. NIH may disclose information from this system of records to
State medical boards for purposes of professional quality assurance
activities.
7. NIH may disclose information from this system of records to
health care facilities for the purpose of verifying that an individual
to whom they intend to grant medical staff or patient care privileges
has or previously held such privileges at the Warren G. Magnuson
Clinical Center.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored on paper forms in file folders and on computer
disks.
RETRIEVABILITY:
Records are retrieved by name, date of birth, type of medical staff
membership, Institute/Center and licensing status.
SAFEGUARDS:
1. Authorized Users: Data on the computer network system is
accessed by a password known only to authorized users who are NIH
employees and contractor staff responsible for implementing the medical
staff credentials data system. 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
entry is controlled by on-site personnel.
3. Procedural and Technical Safeguards: Access to files is strictly
controlled by the system manager. Names and other identifying
particulars are deleted when data from original records are encoded for
analysis. Data stored in computers is accessed through a network system
by use of a password known only to authorized users. All authorized
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,
and the HHS Automated Information Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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 2300-293-4, ``Medical Staffs' Credential Files,''
which allows inactive records to be transferred to the Federal Records
Center at five year intervals and to be
[[Page 67012]]
destroyed after thirty years. Refer to the NIH Manual Chapter for
specific disposition instructions.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Medical Record Department, National Institutes of Health,
10 Center Drive, MSC 1192, Bethesda, MD 20892-1192.
NOTIFICATION PROCEDURE:
To determine if a record exists, write to the system manager at the
above address. The requester must provide tangible proof of identity
(e.g., 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.
RECORD ACCESS PROCEDURE:
Write to the system manager specified above to attain access to
records and provide the same information as that required under the
Notification Procedure. Requesters should also reasonably specify the
record contents being requested. Individuals may also request an
accounting of disclosure of their records, if any.
CONTESTING RECORD PROCEDURE:
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).
RECORD SOURCE CATEGORIES:
Subject individual.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0200
SYSTEM NAME:
Clinical, Epidemiologic, and Biometric Studies of the National
Institutes of Health (NIH), HHS/NIH/OD.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Records are located at NIH and Contractor research facilities which
collect or provide research data for this system. Contractors may
include, but are not limited to: Research centers, clinics, hospitals,
universities, medical schools, research institutions/foundations,
national associations, commercial organizations, collaborating State
and Federal Government agencies, and coordinating centers. A current
list of sites, including the address of any Federal Records Center
where records from this system may be stored, is available by writing
to the appropriate Coordinator listed under Notification Procedure.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Adults and/or children who are the subjects of clinical,
epidemiologic, and biometric research studies of the NIH. Individuals
with disease. Individuals who are representative of the general
population or of special groups including, but not limited to: Normal
controls, normal volunteers, family members and relatives; providers of
services (e.g., health care and social work); health care professionals
and educators, and demographic sub-groups as applicable, such as age,
sex, ethnicity, race, occupation, geographic location; and groups
exposed to real and/or hypothesized risks (e.g., exposure to
biohazardous microbial agents).
CATEGORIES OF RECORDS IN THE SYSTEM:
The system contains data about individuals as relevant to a
particular research study. Examples include, but are not limited to:
Name, study identification number, address, relevant telephone numbers,
social security number (voluntary), driver's license number, date of
birth, weight, height, sex, race; medical, psychological and dental
information, laboratory and diagnostic testing results; registries;
social, economic and demographic data; health services utilization;
insurance and hospital cost data, employers, conditions of the work
environment, exposure to hazardous substances/compounds; information
pertaining to stored biologic specimens (including blood, urine, tissue
and genetic materials), characteristics and activities of health care
providers and educators and trainers (including curricula vitae); and
associated correspondence.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
``Research and Investigation,'' ``Appointment and Authority of the
Directors of the National Research Institutes,'' ``National Cancer
Institute,'' ``National Eye Institute,'' ``National Heart, Lung and
Blood Institute,'' ``National Institute on Aging,'' ``National
Institute on Alcohol Abuse and Alcoholism,'' ``National Institute on
Allergy and Infectious Diseases,'' ``National Institute of Arthritis
and Musculoskeletal and Skin Diseases,'' ``National Institute of Child
Health and Human Development,'' ``National Institute on Deafness and
Other Communication Disorders,'' ``National Institute of Dental and
Craniofacial Research,'' ``National Institute of Diabetes, and
Digestive and Kidney Diseases,'' ``National Institute of Drug Abuse,''
``National Institute of Environmental Health Sciences,'' ``National
Institute of Mental Health,'' ``National Institute of Neurological
Disorders and Stroke,'' and the ``National Human Genome Research
Institute'' of the Public Health Service Act. (42 U.S.C. 241, 242, 248,
281, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i,
285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c,
and 44 U.S.C. 3101.)
PURPOSE(S):
To document, track, monitor and evaluate NIH clinical,
epidemiologic, and biometric research activities.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
1. 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; 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. 241,
42 U.S.C. 290dd-2, 42 CFR part 2, and where applicable, no disclosures
will be made inconsistent with an authorization of confidentiality
under 42 U.S.C. 241 and 42 CFR part 2a; (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 67013]]
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 Member of Congress or to a
Congressional staff member in response to an inquiry of the
Congressional office made at the written request of the constituent
about whom the record is maintained.
3. The Department of Health and Human Services (HHS) may disclose
information from this system of records to the Department of Justice
when: (a) The agency or any component thereof; or (b) any employee of
the agency in his or her official capacity where the Department of
Justice has agreed to represent the employee; or (c) the United States
Government, is a party to litigation or has an interest in such
litigation, and by careful review, the agency determines that the
records are both relevant and necessary to the litigation and the use
of such records by the Department of Justice is, therefore, deemed by
the agency to be for a purpose that is compatible with the purpose for
which the agency collected the records.
4. Disclosure may be made to agency contractors, grantees, experts,
consultants, collaborating researchers, or volunteers who have been
engaged by the agency to assist in the performance of a service related
to this system of records and who need to have access to the records in
order to perform the activity. Recipients shall be required to comply
with the requirements of the Privacy Act of 1974, as amended, pursuant
to 5 U.S.C. 552a(m).
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),
when necessary to obtain information on morbidity and mortality
experiences, and to locate individuals for follow-up studies. Social
security numbers, date of birth and other identifiers 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 when necessary to
locating individuals for participation in follow-up studies.
6. Medical information may be disclosed in identifiable form to
tumor registries for maintenance of health statistics, e.g., for use in
epidemiologic studies.
7. (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).
8. 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.
9. Disclosure may be made to authorized organizations which provide
health services to subject individuals or provide third-party
reimbursement or fiscal intermediary functions, for the purpose of
planning for or providing such services, billing or collecting third-
party reimbursements.
10. The Secretary may disclose information to organizations deemed
qualified to carry out quality assessment, medical audits or
utilization reviews.
11. Disclosure may be made for the purpose of reporting child,
elder, or spousal abuse or neglect or any other type of abuse or
neglect as required by State or Federal law.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records may be stored on index cards, file folders, computer tapes
and disks (including optical disks), photography media, microfiche,
microfilm, and audio and video tapes. For certain studies, 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/computer files.
RETRIEVABILITY:
During data collection stages and follow-up, retrieval is by
personal identifier (e.g., name, social security number, medical record
or study identification number, etc.). During the data analysis stage,
data are normally retrieved by the variables of interest (e.g.,
diagnosis, age, occupation).
SAFEGUARDS:
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; and
statisticians involved in designing sampling plans. Other one-time and
special access by other employees is granted on a need-to-know basis as
specifically authorized by the system manager. Researchers authorized
to conduct research on biologic specimens will typically access 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.
2. Physical Safeguards: Records are either stored in locked rooms
during off-duty hours, locked file cabinets, and/or secured computer
facilities. For certain studies, personal identifiers and link files
are separated and stored in locked files. Computer data access is
limited
[[Page 67014]]
through the use of key words known only to authorized personnel.
3. Procedural Safeguards: Collection and maintenance of data is
consistent 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
anonymous data is provided 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 OHS project directors, contract officers, and project officers
oversee compliance with these requirements. Personnel having access are
trained in Privacy Act requirements. Depending upon the sensitivity of
the information in the record, additional safeguard measures may be
employed.
4. Implementation Guidelines: 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 HHS Automated Information
Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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. Collaborative Perinatal
Project records are retained in accordance with item 3000-G-4, which
does not allow records to be destroyed. Refer to the NIH Manual Chapter
for specific conditions on disposal or retention instructions.
SYSTEM MANAGER(S) AND ADDRESS:
See Appendix I for a listing of current system managers. This
system is for use by all NIH Institutes and Centers. The following
system notices have been subsumed under this umbrella system notice.
09-25-0001, Clinical Research: Patient Records, HHS/NIH/NHLBI.
09-25-0010, Research Resources: Registry of Individuals Potentially
Exposed to Microbial Agents, HHS/NIH/NCI.
09-25-0015, Clinical Research: Collaborative Clinical Epilepsy
Research, HHS/NIH/NINDS.
09-25-0016, Clinical Research: Collaborative Perinatal Project, HHS/
NIH/NINDS.
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.
09-25-0031, Clinical Research: Serological and Virus Data in Studies
Related to the Central Nervous System, HHS/NIH/NINDS.
09-25-0037, Clinical Research: The Baltimore Longitudinal Study of
Aging, HHS/NIH/NIA.
09-25-0038, Clinical Research: Patient Data, HHS/NIH/NIDDK.
09-25-0039, Clinical Research: Diabetes Mellitus Research Study of
Southwestern American Indians, HHS/NIH/NIDDK.
09-25-0040, Clinical Research: Southwestern American Indian Patient
Data, HHS/NIH/NIDDK.
09-25-0042, Clinical Research: National Institute of Dental and
Craniofacial Research Patient Records, HHS/NIH/NIDCR.
09-25-0044, Clinical Research: Sensory Testing Research Program,
HHS/NIH/NIDCR.
09-25-0046, Clinical Research: Catalog of Clinical Specimens from
Patients, Volunteers and Laboratory Personnel, HHS/NIH/NIAID.
09-25-0053, Clinical Research: Vision Studies, HHS/NIH/NEI.
09-25-0057, Clinical Research: Burkitt's Lymphoma Registry, HHS/NIH/
NCI.
09-25-0060, Clinical Research: Division of Clinical Sciences
Clinical Investigations, HHS/NIH/NCI.
09-25-0067, Clinical Research: National Cancer Incidence Surveys,
HHS/NIH/NCI.
09-25-0069, NIH Clinical Center Admissions of the National Cancer
Institute, HHS/NIH/NCI.
09-25-0074, Clinical Research: Division of Cancer Biology and
Diagnosis Patient Trials, HHS/NIH/NCI.
09-25-0077, Biological Carcinogenesis Branch Human Specimen Program,
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.
09-25-0130, Clinical Research: Epidemiologic Studies in the Division
of Cancer Epidemiology and Genetics, HHS/NIH/NCI.
09-25-0134, Clinical Research: Epidemiology Studies, National
Institute of Environmental Health Sciences, HHS/NIH/NIEHS.
09-25-0142, Clinical Research: Records of Subjects in Intramural
Research, Epidemiology, Demography and Biometry Studies on Aging,
HHS/NIH/NIA.
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.
09-25-0145, Clinical Trials and Epidemiological Studies Dealing with
Visual Disease and Disorders in the National Eye Institute, HHS/NIH/
NEI.
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 and Craniofacial Research Contracted
Epidemiological and Biometric Studies, HHS/NIH/NIDCR.
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.
09-25-0170, Diabetes Control and Complications Trial (DCCT) Data
System, HHS/NIH/NIDDK.
09-25-0172, Clinical Research: National Human Genome Research
Institute, HHS/NIH/NHGRI.
09-25-0201, Clinical Research: National Institute of Mental Health
Patient Records, HHS/NIH/NIMH.
09-25-0205, Alcohol, Drug Abuse, and Mental Health Epidemiologic and
Biometric Research Data, HHS/NIH/NIAAA, HHS/NIH/NIDA and HHS/NIH/
NIMH.
09-25-0212, Clinical Research: Neuroscience Research Center Patient
Medical Records, HHS/NIH/NIMH.
NOTIFICATION PROCEDURE:
To determine if a record exists, write to the appropriate IC
Privacy Act Coordinator listed below. In cases where the requester
knows specifically which system manager to contact, he or she may
contact the system manager directly (see Appendix I). Notification
requests should include: 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 in specific cases, a
notarized statement (some
[[Page 67015]]
highly sensitive systems require two witnesses attesting to the
individual's identity). A requester must verify his or her identity by
providing either a notarization of the request or by submitting 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 will be granted direct access to their medical records
unless the system manager determines that such access is likely to have
an adverse effect (i.e., could cause harm) on the individual. In such
cases when the system manager has determined that the nature of the
record information requires medical interpretation, the subject of the
record shall be requested to 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, other health professional, or
other responsible individual. In this case, the medical/dental record
will be sent to the designated representative. Individuals will be
informed in writing if the record is sent to the representative. This
same procedure will apply in cases where a parent or guardian requests
notification of, or access to, a child's or incompetent person's
medical record. The parent or guardian must also verify (provide
adequate documentation) their relationship to the child or incompetent
person as well as his or her own identity to prove their relationship.
If the requester does not know which Institute or Center Privacy
Act Coordinator to contact for notification purposes, he or she may
contact directly the NIH Privacy Act Officer at the following address:
NIH Privacy Act Officer, Office of Management Assessment, 6011
Executive Blvd., Room 601L, Rockville, MD 20852.
NIH Privacy Act Coordinators
Office of the Director, (OD), NIH, Associate Director for Disease
Prevention, OD, NIH, Building 1, Room 260, 1 Center Drive, Bethesda,
MD 20892.
National Cancer Institute (NCI), Privacy Act Coordinator, NCI, NIH,
Building 31, Room 10A34, 31 Center Drive, Bethesda, MD 20892.
National Eye Institute (NEI), Privacy Act Coordinator, NEI, NIH,
Building 31, Room 6A32, 31 Center Drive, MSC 2510, Bethesda, MD
20892-2510.
National Heart, Lung and Blood Institute (NHLBI), Privacy Act
Coordinator, NHLBI, NIH, Building 31, Room 5A08, 31 Center Drive,
Bethesda, MD 20892.
National Institute on Aging (NIA), Privacy Act Coordinator, NIA,
NIH, Building 31, Room 2C12, 31 Center Drive, Bethesda, MD 20892.
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Privacy
Act Coordinator, NIAAA, NIH, Willco Building, Suite, 6000 Executive
Blvd., MSC 7003, Bethesda, MD 20892-7003.
National Institute of Allergy and Infectious Diseases (NIAID),
Privacy Act Coordinator, NIAID, NIH, Solar Building, Room 3C-23,
6003 Executive Blvd., Bethesda, MD 20892.
National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS), Privacy Act Coordinator, NIAMS, NIH, Natcher
Building, Room 5AS49, 45 Center Drive, Bethesda, MD 20892.
National Institute of Child Health and Human Development (NICHD),
Privacy Act Coordinator, NICHD, NIH, 6100 Executive Blvd., Room
5D01, Bethesda, MD 20892.
National Institute on Deafness and Other Communication Disorders
(NIDCD), Privacy Act Coordinator, NIDCD, NIH, Building 31, Room
3C02, 9000 Rockville Pike, Bethesda, MD 20892.
National Institute of Dental and Craniofacial Research (NIDCR),
Privacy Act Coordinator, NIDCR, NIH, Natcher Building, Room 4AS-43A,
45 Center Drive, MSC 6401, Bethesda, MD 20892-6401.
National Institute of Diabetes and Digestive and Kidney Disease
(NIDDK), Privacy Act Coordinator, NIDDK, NIH, Building 31, Room
9A47, 31 Center Drive, Bethesda, MD 20892.
National Institute on Drug Abuse (NIDA), Privacy Act Coordinator,
NIDA, NIH, Parklawn Building, Room 10A-42, 5600 Fishers Lane,
Rockville, MD 20857.
National Institute of Environmental Health Sciences (NIEHS), Privacy
Act Coordinator, NIEHS, NIH, PO Box 12233, Research Triangle Park,
NC 27709.
National Institute of Mental Health (NIMH), Privacy Act Coordinator,
NIMH, NIH, Parklawn Building, Room 7C-22, 5600 Fishers Lane,
Rockville, MD 20857.
National Institute of Neurological Disorders and Stroke (NINDS),
Privacy Act Coordinator, NINDS, NIH, Federal Building, Room 816,
7550 Wisconsin Avenue, Bethesda, MD 20892.
National Human Genome Research Institute (NHGRI), Office of Policy
Coordination, Bldg. 31, Room 4B09, Bethesda, MD 20892.
RECORD ACCESS PROCEDURE:
Same as Notification Procedure. Requesters should reasonably
specify the record contents being sought. An individual may also
request an accounting of disclosures of his/her record, if any.
CONTESTING RECORD PROCEDURE:
Contact the appropriate official at the address specified under
Notification Procedure, 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.
RECORD SOURCE CATEGORIES:
The system contains information obtained directly from the subject
individual by interview (face-to-face or telephone), 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, including but not limited to: Referring medical
physicians, mental health/alcohol/drug abuse or other health care
providers; hospitals; organizations providing biological specimens;
relatives; guardians; schools; and clinical medical research records.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
Appendix I: System Manager(s) and Address(es)
Office of the Director, NIH, Associate Director for Disease
Prevention, OD, NIH, Building 1, Room 260, 1 Center Drive, Bethesda,
MD 20892.
National Cancer Institute, Computer Systems Analyst, DCBD, NCI, NIH,
Executive Plaza North, Room 344, Bethesda, MD 20892.
American Burkitt's Lymphoma Registry, Division of Cancer Etiology,
NCI, NIH, Executive Plaza North, Suite 434, 6130 Executive Blvd.,
Bethesda, MD 20892.
Chief, Genetic Epidemiology Branch, DCEG, NCI, NIH, Executive Plaza
South, Room 7122, MSC 7236, 6120 Executive Blvd., Bethesda, MD
20892-7236.
Program Director, Research Resources, Biological Carcinogenesis
Branch, DCE, NCI, NIH, Executive Plaza North, Room 540, 6130
Executive Blvd., Bethesda, MD 20892.
Chief, Environmental Epidemiology Branch, DCE, NCI, NIH, Executive
Plaza North, Room 443, 6130 Executive Blvd., Bethesda, MD 20892.
Associate Director, Surveillance Program, DCPC, NCI, NIH, Executive
Plaza North, Room 343K, 6130 Executive Blvd., Bethesda, MD 20892.
Head, Biostatistics and Data Management Section, DCS, NCI, NIH, 6116
Executive Blvd., Room 702, Bethesda, MD 20892.
Chief, Clinical Research Branch, Biological Response Modifiers
Program, Frederick Cancer Research and Development Center, DCT, NCI,
NIH, 501 W. 7th Street, Suite #3, Frederick, MD 21701.
[[Page 67016]]
Deputy Branch Chief, Navy Hospital, NCI--Naval Medical Oncology
Branch, DCT, NCI, NIH, Building 8, Room 5101, Bethesda, MD 20814.
Chief, Pharmaceutical Management Branch, Cancer Therapy Evaluation
Program, DCT, NCI, NIH, Executive Plaza North, Suite 804, Bethesda,
MD 20892.
Director, Extramural Clinical Studies, BRB, BRMP, DCT, NCI, NIH,
Frederick Cancer Research and Development Center, Fort Detrick,
Frederick, MD 21701.
National Eye Institute, Clinical Director, NEI, NIH, Building 10,
Room 10N-202, 10 Center Drive, Bethesda, MD 20892.
Director, Division of Biometry and Epidemiology, NEI, NIH, Building
31, Room 6A-52, 31 Center Drive, Bethesda, MD 20892.
National Heart Lung and Blood Institute, Administrative Officer,
Division of Intramural Research, NHLBI, NIH, Building 10 Room 7N220,
10 Center Drive, MSC 1670, Bethesda, MD 20892-1670.
Senior Scientific Advisor, OD, Division of Epidemiology and Clinical
Applications, NHLBI, NIH, Federal Building, 220, 7550 Wisconsin
Avenue, Bethesda, MD 20892.
National Institute on Aging, Computer Scientist, Longitudinal
Studies Branch, IRP, NIH, Gerontology Research Center, GRC, 4940
Eastern Avenue, Baltimore, MD 21224.
Associate Director, Epidemiology, Demography and Biometry Program,
NIA, NIH, Gateway Building, Suite 3C309, 7201 Wisconsin Avenue,
Bethesda, MD 20892.
National Institute on Alcohol Abuse and Alcoholism, Deputy Director,
Division of Biometry and Epidemiology, NIAAA, NIH, Willco Building,
Suite 514, 6000 Executive Blvd., MSC 7003, Bethesda, MD 20892-7003.
Deputy Director, Div. of Clinical and Prevention Res., NIAAA, NIH,
Willco Building, Suite 505, 6000 Executive Blvd., MSC 7003,
Bethesda, MD 20892-7003.
National Institute of Allergy and Infectious Diseases, Chief,
Respiratory Viruses Section, LID, NIAID, NIH, Building 7, Room 106,
9000 Rockville Pike, Bethesda, MD 20892.
Chief, Hepatitis Virus Section, LID, NIAID, NIH, Building 7, Room
202, 9000 Rockville Pike, Bethesda, MD 20892.
Chief, Epidemiology and Biometry Branch, DMID, NIAID, NIH, Solar
Building, Room 3A24, Bethesda, MD 20892.
Special Assistant, Clinical Research Program, DAIDS, NIAID, NIH,
Solar Building, Room 2C-20, 6003 Executive Blvd., Bethesda, MD
20892.
National Institute of Arthritis and Musculoskeletal and Skin
Diseases, Clinical Director, NIAMS, NIH, Building 10, Room 9S205, 10
Center Drive, Bethesda, MD 20892.
National Institute of Child Health and Human Development, Chief,
Contracts Management Branch, NICHD, NIH, Executive Plaza North, Room
7A07, 6100 Executive Blvd., North Bethesda, MD 20892.
National Institute on Deafness and Other Communication Disorders,
Acting Director of Intramural Research, NIDCD, NIH, Building 31,
Room 3C02, 31 Center Drive, Bethesda, MD 20892.
Director, Division of Human Communication, NIDCD, NIH, Executive
Plaza South, Room 400C, 6120 Executive Boulevard, MSC 7180,
Bethesda, MD 20892-7180.
National Institute of Dental and Craniofacial Research, Deputy
Clinical Director, NIDCR, NIH, Building 10, Room 1N-113, 10 Center
Drive, MSC 1190, Bethesda, MD 20892-1190.
Research Psychologist, Gene Therapy and Therapeutics Branch, NIDCR,
NIH, Building 10, Room 1N114, 10 Center Drive, MSC 1190, Bethesda,
MD 20892-1190.
National Institute of Diabetes and Digestive and Kidney Diseases,
Chief, Clinical Investigations, NIDDK, NIH, Building 10, Room 9N222,
10 Center Drive, Bethesda, MD 20892.
Chief, Phoenix Clinical Research Section, NIDDK, NIH, Phoenix Area
Indian Hospital, Room 541, 4212 North 16th Street, Phoenix, AZ
85016.
Chief, Diabetes Research Section, DPB, DDEMD, NIDDK, NIH, Natcher
Building, Room 5AN-18G, 45 Center Drive, MSC 6600, Bethesda, MD
20892.
National Institute on Drug Abuse, Privacy Act Coordinator, NIDA,
NIH, Parklawn Building, Room 10A-42, 5600 Fishers Lane, Rockville,
MD 20857.
National Institute of Environmental Health Sciences, Chief,
Epidemiology Branch, NIEHS, NIH, PO Box 12233, Research Triangle
Park, NC 27709.
National Institute of Mental Health, Director, Intramural Research
Program, NIMH, NIH, Building 10, Room 4N-224, 9000 Rockville Pike,
Bethesda, MD 20892.
Privacy Act Coordinator, NIMH, NIH, 6001 Executive Blvd., Room 6112,
Bethesda, MD 20982.
National Institute of Neurological Disorders and Stroke, Privacy Act
Coordinator, NINDS, NIH, Neuroscience Center, 6001 Executive Blvd.,
Suite 3305, MSC 9531, Bethesda, MD 20892-9531.
Chief, Epilepsy Branch, NINDS, NIH, Neuroscience Center, 6001
Executive Blvd., Suite 2110, MSC 9523, Bethesda, MD 20892-9523.
Assistant Director, CNP, DIR, NINDS, NIH, Building 10, Room 5N226,
10 Center Drive, Bethesda, MD 20892.
Deputy Chief, Laboratory of Central Nervous Systems Studies,
Intramural Research Program, NINDS, NIH, Building 36, Room 5B21,
9000 Rockville Pike, Bethesda, MD 20892.
Director, Division of Fundamental Neuroscience and Developmental
Disorders, NINDS, NIH, Neuroscience Center, 6001 Executive Blvd.,
Suite 2136, MSC 9527, Bethesda, MD 20892-9527.
Director, Division of Convulsive, Infectious and Immune Disorders,
NINDS, NIH, Neuroscience Center, 6001 Executive Blvd., Suite 2110,
MSC 9521, Bethesda, MD 20892-9521.
Director, Division of Stroke, Trauma, and Neurodegenerative
Disorders, NINDS, NIH, Neuroscience Center, 6001 Executive Blvd.,
Suite 2209, MSC 9525, Bethesda, MD 20892-9525.
Division of Experimental Therapeutics and Clinical Trials, NINDS,
NIH, Neuroscience Center, 6001 Executive Blvd., Suite 2213, MSC
9520, Bethesda, MD 20892-9520.
National Human Genome Research Institute (NHGRI), Clinical Director,
NHGRI, Bldg. 10, Room 10C101D, 10 Center Drive, Bethesda, MD 20892.
09-25-0202
SYSTEM NAME:
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.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institute on Drug Abuse, Intramural Research Program,
Johns Hopkins Bayview Medical Center, P.O. Box 5180, Baltimore, MD
21224.
Federal Records Center, 1557 St. Joseph Avenue, East Point, GA
30344.
Washington National Records Center, 4205 Suitland Road, Washington,
DC 20409.
Iron Mountain, 8200 Preston Court, Suite One, Jessup, MD 20794.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
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.
CATEGORIES OF RECORDS IN THE SYSTEM:
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.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
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)).
PURPOSE(S):
The records were collected originally to monitor the individual's
progress
[[Page 67017]]
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.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
None.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
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.
RETRIEVABILITY:
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.
SAFEGUARDS:
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: 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 HHS Automated Information
Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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 records will be shredded in 2003 upon written
request from the system manager.
SYSTEM MANAGER(S) AND ADDRESS:
Medical Records Officer, National Institute on Drug Abuse,
Intramural Research Program, Johns Hopkins Bayview Medical Center, Box
5180, Baltimore, MD 21224.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
Same as Notification Procedure. 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.
CONTESTING RECORD PROCEDURE:
Contact the official at the address specified under Notification
Procedure 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.
RECORD SOURCE CATEGORIES:
Patients; patients' drug treatment program counselors; court
records; hospital personnel.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0203
SYSTEM NAME:
National Institute on Drug Abuse, Intramural Research Program,
Federal Prisoner and Non-Prisoner Research Files, HHS/NIH/NIDA.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institute on Drug Abuse, Intramural Research Program, PO
Box 5180, Baltimore, MD 21224.
Quest, Pathology Building, 1901 Silver Spring Road, Baltimore, MD
21227.
Federal Records Center, 1557 St. Joseph Avenue, East Point, GA
30344.
Washington National Records Center, 4205 Suitland Road, Washington,
DC 20409.
NOVA, Johns Hopkins Bayview Medical Center, Building C, 4940
Eastern Avenue, Baltimore, MD 21224.
Iron Mountain, 8200 Preston Court, Suite One, Jessup, MD 20794.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Volunteers, adult males (from 1968 to present), adult females
(beginning in l985) 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.
CATEGORIES OF RECORDS IN THE SYSTEM:
The categories of records involved are administrative, medical and
research records.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
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)); sections 503
and 515 (42 U.S.C. 290aa-2 and 290cc). These sections authorize the
conduct of research in all areas of drug abuse.
PURPOSE(S):
1. To collect and maintain a data base for research activities at
NIDA/IRP.
2. To enable Federal drug abuse researchers to evaluate and monitor
the subjects' health during participation in a research project. The
areas of research
[[Page 67018]]
include, but are not limited to, biomedical, clinical, behavioral,
pharmacological, psychiatric, psychosocial, epidemiological,
etiological, statistical, treatment and prevention of narcotic
addiction and drug abuse.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Data may be stored in file folders or on computer disks, magnetic
tapes, or microfilm.
RETRIEVABILITY:
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.
SAFEGUARDS:
1. Authorized Users: 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: 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 HHS Automated Information
Systems Security Program Handbook.
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.''
RETENTION AND DISPOSAL:
Records will be disposed of in accordance with the NIH Records
Control Schedule, i.e., when the records are ten years old or no longer
required for administrative or research purposes.
SYSTEM MANAGER(S) AND ADDRESS:
Medical Records Officer, NIDA, Intramural Research Program, Johns
Hopkins Bayview Medical Center--Building C, PO Box 5180, Baltimore, MD
21224.
NOTIFICATION PROCEDURE:
To determine if a record exists, write to the system manager at the
address above. Provide a notarized signature as proof of identity. 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.
RECORD ACCESS PROCEDURE:
Same as Notification Procedure. 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.
[[Page 67019]]
CONTESTING RECORD PROCEDURE:
Contact the official at the address specified under Notification
Procedure 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.
RECORD SOURCE CATEGORIES:
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.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0207
SYSTEM NAME:
Subject-Participants in Pharmacokinetic Studies on Drugs of Abuse
and on Treatment Medications, HHS/NIH/NIDA.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
University of California, San Francisco, Langley Porter Psychiatric
Institute, San Francisco, CA 94143.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
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.
CATEGORIES OF RECORDS IN THE SYSTEM:
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.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Public Health Service Act, sections 301(a), 503 and 405 (42 U.S.C.
241 and 284).
PURPOSE(S):
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 develop standards on the composition, quality,
safety, and efficacy of drugs administered to humans, and to monitor
experimental usage of drugs.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
The contractor maintains the records on paper in file folders.
RETRIEVABILITY:
The contractor indexes and retrieves the records by the subject-
participant's name.
SAFEGUARDS:
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: 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 HHS Automated Information
Systems Security Program Handbook. In addition, the contract staff
complies with contractor's (University of California, San Francisco)
standard procedures for safeguarding data.
RETENTION AND DISPOSAL:
The records will be kept no later than June 2002 (five 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.
SYSTEM MANAGER(S) AND ADDRESS:
Project Officer, Pharmacokinetic Studies on Drugs of Abuse,
Medications Development Division, National Institute on Drug Abuse,
National Institutes of Health, 6001 Executive Blvd., Room 4123, MSC
9551, Rockville, MD 20892-9551.
NOTIFICATION PROCEDURE:
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.
[[Page 67020]]
RECORD ACCESS PROCEDURE:
Same as Notification Procedure. 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.
CONTESTING RECORD PROCEDURE:
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.
RECORD SOURCE CATEGORIES:
The subject-participants and the contractor personnel conducting
the research studies.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0208
SYSTEM NAME:
Drug Abuse Treatment Outcome Study (DATOS), HHS/NIH/NIDA.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Research Triangle Institute, Center for Social Research and Policy
Analysis, Research Triangle Park, NC 27709.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
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.
CATEGORIES OF RECORDS IN THE SYSTEM:
The categories are: Demographic data, treatment outcome data,
treatment process data, client locator information, and personal
identifiers (name and assigned numerical identifier).
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Public Health Service Act, sections 301 and 405 (42 U.S.C. 241 and
284.
PURPOSE(S):
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.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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 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 follow-up 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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Interview forms, magnetic tapes, and disks.
RETRIEVABILITY:
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.
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
[[Page 67021]]
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 follow-up 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: 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 HHS Automated Information
Systems Security Program Handbook. 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.
RETENTION AND DISPOSAL:
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 five 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
five 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 ten years old or when they are no longer needed
for research purposes.
SYSTEM MANAGER(S) AND ADDRESS(ES):
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, 6001
Executive Blvd., Room 4222, Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
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/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 in 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.
RECORD ACCESS PROCEDURE:
Same as Notification Procedure. 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.
CONTESTING RECORD PROCEDURE:
Contact the official at the address specified under Notification
Procedure 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.
RECORD SOURCE CATEGORIES:
Research subjects, and staff in participating drug abuse treatment
programs, written clinical evaluations, counselors, psychiatrists,
psychotherapists, family members, research assistants, hospitals.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0209
SYSTEM NAME:
Subject-Participants in Drug Abuse Research Studies on Drug
Dependence and in Research Supporting New Drug Applications, HHS/NIH/
NIDA.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Veterans Administration Hospital, Cooperative Studies Program,
Department of Veterans Medical Center, Perry Point, MD 21902.
Dixon and Williams Pharmaceutical, 5775 Hyde Park Circle,
Jacksonville, FL 32210.
Medications Development Division and Division of Clinical Research,
National Institute on Drug Abuse, 6001 Executive Blvd., Room 4123,
Bethesda, MD 20892.
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.
[[Page 67022]]
Write to the system manager at the address below for the address of
any new locations where records from this system may be stored.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
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 continued 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 calendar year 2005.
CATEGORIES OF RECORDS IN THE SYSTEM:
Demographic data, treatment outcome data, treatment process data,
client locator information, and personal identifiers (name and assigned
numerical identifier).
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Public Health Service Act, Sections 301, 464p, and 405 (42 U.S.C.
241, and 284).
PURPOSE(S):
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.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
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 follow-up 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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Interview and assessment forms, video tapes, magnetic tapes, disks,
and microfiche in boxes in closed cabinets in a locked room with
limited accessibility.
RETRIEVABILITY:
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.
SAFEGUARDS:
1. Authorized Users: For the naltrexone study, the system manager
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 may 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
[[Page 67023]]
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: 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 HHS Automated Information
Systems Security Program Handbook.
RETENTION AND DISPOSAL:
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 five 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 two 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 five years old or when they
are no longer needed for research purposes.
SYSTEM MANAGER(S) AND ADDRESS:
Project Officer, Naltrexone Study, Division of Clinical Research,
National Institute on Drug Abuse, 6001 Executive Blvd., Room 4234,
Bethesda, MD 20892.
Project Officer, LAAM and Other Research Records, Medications
Development Division, National Institute on Drug Abuse, 6001 Executive
Blvd., Room 4128, Bethesda, MD 20892.
NOTIFICATION PROCEDURE:
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.
RECORD ACCESS PROCEDURE:
Same as Notification Procedure. 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.
CONTESTING RECORD PROCEDURE:
Contact the official at the address specified under Notification
Procedure 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.
RECORD SOURCE CATEGORIES:
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.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0210
SYSTEM NAME:
Shipment Records of Drugs of Abuse to Authorized Researchers, HHS/
NIH/NIDA.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Basic Neurobiology and Biological Systems Research Branch (BNBSRB),
Division of Basic Research, National Institute on Drug Abuse, 6001
Executive Blvd., Room 4282, MSC 9555, Bethesda, MD 20892-9555.
Research Triangle Institute, Research Triangle Park, NC 27709.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Individual researchers and organizations who are registered with
the Drug Enforcement Administration (DEA), Department of Justice (DOJ),
some since 1966, and who have voluntarily submitted documentation to
the National Institute on Drug Abuse (NIDA) in order to obtain, through
the NIDA Drug Supply Program (DSP), drugs of abuse for use in a
research project.
CATEGORIES OF RECORDS IN THE SYSTEM:
While the records in this system are research project-related, they
support the eligibility of individual researchers to receive drugs of
abuse. Types of information contained in the records are: Researcher's
name, curricula vitae, research protocol, DEA and (if applicable)
Nuclear Regulatory Commission registration numbers (when a radiolabeled
compound is requested and shipped), business address (location of
research project) and telephone number, summary of research project(s),
requests for substance(s), name and amount of each compound requested
and shipped, dates material is shipped and received, shipment numbers,
and order form numbers.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Public Health Service Act, sections 301, and 405 (42 U.S.C. 241 and
284); Controlled Substances Act of 1970 (21 U.S.C. 801 et seq.); Atomic
Energy Act of 1954, as amended, section 81 (42 U.S.C 2111); and Energy
Reorganization Act of 1974, section 201 (42 U.S.C. 5841).
PURPOSE(S):
To facilitate operation of DSP which is a centralized research
support service through which the United States Government supplies to
the national and international scientific community for research
purposes, most Schedule I and many Schedule II-V controlled and non-
controlled substances as specified in the Controlled Substances Act
(CSA) of 1970 (21 U.S.C. 801 et seq.). Controlled substances are
chemicals and other substances, and their immediate precursors, that
the Attorney General has determined to have such potential
[[Page 67024]]
for abuse as to warrant regulation under the CSA. Some of these
substances are radiolabeled materials. Radiolabeled materials are
substances to which a small amount of radioactivity is added for use in
various studies, such as drug metabolism and mechanisms of drug
actions.
This system of records was established to facilitate DSP by
enabling NIDA:
1. To verify that requests for drugs of abuse, some of which are
radiolabeled, are from authorized individuals/organizations for use in
a research project;
2. To verify that the amounts of the materials requested by
researchers for animal, in vivo, and in vitro research are justified
and available;
3. To supply controlled substances in amounts approved by the Food
and Drug Administration (FDA) to researchers conducting research with
human subjects;
4. To ship these materials securely in accordance with CSA and the
Atomic Energy Act; and
5. To maintain records of these transactions.
FDA also may use the records in routine inspections in accordance
with FDA's responsibilities to develop standards on the composition,
safety, and efficacy of drugs administered to humans, and to monitor
experimental usage of drugs.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
1. We may disclose the record of an individual to a congressional
office in response to a verified inquiry from the congressional office
made at the written request of the individual.
2. We may disclose information to DEA, DOJ, to enable DEA to carry
out its responsibilities as described in the Controlled Substances Act
of 1970.
3. An NIH contractor routinely uses the records in this system to
ship controlled substances to authorized recipients. Such contractor is
required to maintain Privacy Act safeguards with respect to these
records.
4. An NIH contractor may have access to the records in this system
in the performance of its software modification/correction tasks
specified in its contract. Such contractor is required to maintain
Privacy Act safeguards with respect to these records.
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
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, the 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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
NIDA maintains ``hard copy'' records in file folders and automated
records on computer disk.
RETRIEVABILITY:
Authorized NIDA and contractor personnel index and retrieve the
computerized records by a researcher code number assigned by a computer
program at the time a new record is established. Authorized NIDA
personnel index and retrieve ``hard copy'' records by researcher's
name. NIDA maintains a computerized, alphabetical cross-reference list
that matches names and numbers.
SAFEGUARDS:
1. Authorized Users: The Chief, BNBSR Branch and his or her support
staff, program assistant and clerk-typist, and the contracts' project
directors and their support staffs have access to the records.
2. Physical Safeguards: The ``hard copy'' records and main computer
are physically located at the Neuroscience Center, Bethesda, Maryland.
The computerized records are kept in a room with limited
admittance. The room is locked after working hours. The ``hard copy''
records are stored in locked file cabinets in a room with very limited
admittance. This room is also locked after working hours. The
Neuroscience Center has a 24-hour guard patrol service.
3. Procedural Safeguards: The terminals are housed in a secured
work area with limited admittance. Contract personnel use a password
identification system to obtain access; NIDA changes the passwords
periodically.
4. Implementation Guidelines: 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 HHS Automated Information
Systems Security Program Handbook.
RETENTION AND DISPOSAL:
NIDA maintains an individual's record for five years after the
researcher's last request for, or shipment of, a drug of abuse. We
consider the record inactive after that, and erase it from the computer
disk by a delete routine. The delete routine automatically deletes the
computerized cross-reference as well. We destroy the ``hard copy''
record by shredding. The system is checked once a year for inactive
records.
SYSTEM MANAGER(S) AND ADDRESS:
Project Director, Drug Supply Program, BNBSR Branch, Division of
Basic Research, Neuroscience Center, 6001 Executive Blvd., Room 4282,
MSC 9555, Bethesda, MD 20892-9555.
NOTIFICATION PROCEDURE:
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. The request should include the
researcher's name and business address at the time of last shipment.
The request must be signed in ink by the individual researcher.
Verifiable proof of identity is required.
RECORD ACCESS PROCEDURE:
Same as Notification Procedure. 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.
CONTESTING RECORD PROCEDURE:
Contact the official at the address specified under Notification
Procedure 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.
RECORD SOURCE CATEGORIES:
Initial source is the individual researcher. Some of the DEA
registration information provided by a researcher is verified through a
DEA computer check. FDA provides information concerning type and amount
of controlled substance(s) to be shipped to an
[[Page 67025]]
individual researcher for research projects involving human subjects.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0211
SYSTEM NAME:
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.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institutes of Health, 9000 Rockville Pike, Bethesda, MD
20892. A list of specific project sites is available from the system
manager.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
In-and out-patients with alcohol abuse and dependence, alcohol-
induced organic brain syndromes; their relatives; and healthy
volunteers.
CATEGORIES OF RECORDS IN THE SYSTEM:
Research data of wide variety including biochemical measures,
psychophysiological and psychological tests, questionnaires, clinical
and behavioral observations and interviews, physical examinations, and
correspondence.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Public Health Service Act, as amended, sections 301 (42 U.S.C. 241)
and 510 (42 U.S.C. 290bb). These sections authorize the conduct of
general health research and research into alcoholism and alcohol abuse.
PURPOSE(S):
These records are used for diagnosis and treatment of patients with
alcohol abuse and dependence and related conditions; behavioral
research relating to the causes, diagnoses, and treatment of
addictions; and basic research on behavioral and biological processes.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
Records in this system are covered by section 527 of the Public
Health Service Act (42 U.S.C. 290ee-3) and 42 CFR, Chapter I,
subchapter A, part 2, on confidentiality of alcohol and drug abuse
patient records. In accordance with these regulations, the records are
confidential and may only be disclosed with the written consent of the
patient with specific restrictions, and without the patient's consent
in the following instances: (1) To medical personnel to the extent
necessary to meet a bona fide emergency; (2) to qualified personnel for
the purpose of conducting scientific research; or (3) if authorized by
an appropriate order of a court of competent jurisdiction granted after
application showing good cause therefore, after certain considerations,
and with appropriate safeguards. Routine uses of information in this
system are limited to the following:
1. 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, 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; (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 the
congressional office at the written request of that individual, in
accordance with 42 CFR, chapter I, subchapter A, part 2.
Records may be disclosed to student volunteers, individuals working
under a personal services contract, and other individuals performing
functions for PHS who do not technically have the status of agency
employees, if they need the records in the performance of their agency
functions.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records may be stored in file folders, on index cards, 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.
RETRIEVABILITY:
During data collection stages and follow-up, retrieval by personal
identifier (e.g., name or medical record number) is necessary. During
the data analysis stage, data are normally retrieved by variables of
interest, e.g., age, diagnosis, etc.
SAFEGUARDS:
Measures to prevent unauthorized disclosures are implemented as
appropriate for the particular records maintained in each project.
Depending on the sensitivity of the project, additional safeguards may
be added.
1. Authorized Users: Only NIAAA medical and research staff have
access to these records, as authorized by the system manager.
2. Physical Safeguards: Records are stored in locked rooms, locked
file cabinets, and/or secured computer facilities. Personal identifiers
and link codes are separated as much as possible and stored in locked
files.
3. Procedural Safeguards: Collection and maintenance of data are
consistent with legislation and regulations for protection of human
subjects, informed consent, confidentiality, and confidentiality
specific to drug and alcohol abuse patients. Computer data access is
limited through the use of key words, a series of account numbers, and
passwords which are changed frequently and known only to authorized
personnel.
4. Implementation Guidelines: 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 HHS Automated Information
Systems Security Program Handbook.
RETENTION AND DISPOSAL:
Records are held for five years after completion of the project,
retired to a
[[Page 67026]]
Federal Records Center, and subsequently disposed of after ten years.
SYSTEM MANAGER(S) AND ADDRESS:
Clinical Director, Laboratory of Clinical Studies, Division of
Intramural Clinical and Biological Research, National Institutes of
Health, Building 10, Room 3B-19, 9000 Rockville Pike, Bethesda, MD
20892.
NOTIFICATION PROCEDURE:
To determine if a record exists, write to the system manager at the
address above. Provide notarized signature as proof of identity. The
request should include as much of the following information as
possible: (a) Full name; (b) nature of illness (if any); (c) title of
study; (d) name of researcher conducting study. 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 child's/
incompetent person's record shall at the time the request is made
designate a family physician or other health professional (other than a
family member) to whom the record, if any, will be sent. The designee
will receive the record in all cases and upon review will determine
whether the record should be made available to the parent or guardian.
RECORD ACCESS PROCEDURE:
Same as Notification Procedure. Requesters should also reasonably
specify the record contents being sought. Individuals may also request
an accounting of disclosures of their records, if any.
CONTESTING RECORD PROCEDURE:
Contact the official at the address specified under Notification
Procedure 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.
RECORD SOURCE CATEGORIES:
Information gathered from individuals under study, either patient
or normal subject, contract surveys, hospital records, medical and
nursing staff notes, and from Privacy Act system of records 90-25-0099,
``Clinical Research: Patient Medical Records, HHS/NIH/CC.''
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. 99-30419 Filed 11-29-99; 8:45 am]
BILLING CODE 4140-01-P
