[Federal Register Volume 59, Number 24 (Friday, February 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2542]
[[Page Unknown]]
[Federal Register: February 4, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Agency Forms Submitted to the Office of Management and Budget for
Clearance
Each Friday the Public Health Service (PHS) publishes a list of
information collection requests it has submitted to the Office of
Management and Budget (OMB) for clearance in compliance with the
Paperwork Reduction Act (44 U.S.C. Chapter 35). The following requests
have been submitted to OMB since the list was last published on Friday,
January 14, 1994.
(Call PHS Reports Clearance Officer on 202-690-7100 for copies of
request).
1. Behavorial, Biochemical, Endocrine and Genetic Study of Alcohol
Abusing Violent Offenders--0925-0390 (Reinstatement)--NIAAA requires
information on genetic and biochemical determinants of alcohol abuse
and alcoholism. This information will be collected by psychiatric
interview data, behavioral observation and laboratory testing of
specimens obtained from violent offenders, their blood relatives and
matched controls. The data collected will be used to further our
understanding of the transmission and results of alcohol abuse.
Respondents: Individuals or households; Number of Respondents: 200;
Number of Responses per Respondent: 1; Average Burden per Response: 8
hours; Estimated Annual Burden: 1600 hours.
2. Survey of Kidney Transplant Centers Regarding Living-Related
Donations--New--Transplant centers vary in their use of kidneys donated
by potential recipients' living relatives. This survey of all kidney
transplant centers will identify institutional factors influencing
living-related donation rates. It will enable the Health Resources and
Services Administration to describe team and center characteristics
that support appropriate use of this cost-effective alternative to
long-term dialysis. Respondents: Businesses or other for-profit; Non-
profit institutions, Small businesses or organizations; Number of
Respondents: 900; Number of Responses per Respondent: 1; Average Burden
per Response: .29 hour; Estimated Annual Burden: 260 hours.
3. Grants for Hospital Construction and Modernization--Federal
Right of Recovery and Waiver of Recovery (42 CFR 124, Subpart H)--0915-
0099 (Extension)--``Federal Right of Recovery and Waiver of Recovery''
provides a means for the Federal Government to recover grant funds and
a method of calculating interest when a grant-assisted facility is sold
or leased, or there is a change in use of the facility. It also allows
for a waiver of the right of recovery under certain circumstances.
Respondents: State or local governments, Businesses or other-for-
profit; non-profit institutions; Number of Respondents: 20; Number of
Responses per Respondent: 1; Average Burden per Response: 3 hours;
Estimated Annual Burden: 60 hours.
4. NIH Intramural Research Training Award (Program Application)--
0925-0299 (Extension, no charge)--The information collection will be
used to make fellowship awards to qualified applicant individuals.
Awardees will receive training in biomedical research at the National
Institutes of Health. Respondents: Individuals or households; Number of
Respondents: 10,600; Number of Responses per Respondent: 1; Average
Burden per Response: .55 hour; Estimated Annual Burden: 5,800 hours.
5. Loan Information System Records for the DHHS and DHUD Hospital
Mortgage Insurance, Guarantee, and Direct Loan Programs--New--Operating
statistics and financial information will be collected from hospitals
with mortgages that are insured by the Department of Health and Human
Services or the Department of Housing and Urban Development. The
information will be used to monitor the financial stability of the
hospitals to protect the Federal investment in these facilities.
Respondents: State or local governments, Businesses or other for-
profit, Non-profit institutions; Number of Respondents: 316; Number of
Responses Per Respondent: 1; Average Burden Per Response: 1 hour;
Estimated Annual Burden: 316 hours.
6. Establishment and Product Applications for Licenses for the
Manufacture of Biological, Allergenic and Plasma Derivative Products,
Blood and Blood Products--0910-0124--(Revision) Sec. 351, PHS Act & 21
CFR 601.2 requires all manufacturers of biological products to submit
applications for review and approval to the Food and Drug
Administration prior to marketing a product. A separate license is
issued to the manufacturer for each approved product application. The
date is used to determine if the manufacturer is in compliance with
license provisions of the regulations. Respondents: Businesses or other
for-profit, Non-profit institutions, Small businesses or organizations.
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Number of Average
Number of responses burden
Title respondents per per
respondent response
(hours)
------------------------------------------------------------------------
Reporting--FDA 2599, FDA 2599a....... 44 3.09 2.18
Reporting--FDA 2600, 2600b........... 68 3.71 2
Reporting--Form FDA 3066............. 12 5.25 6
Reporting--Form FDA 3086............. 0 0 3
Reporting--Form FDA 3096............. 1 1 2.5
Reporting--Forms FDA 3098, 3098a,
3098b, 3098c, 3098d, 3098e.......... 100 8.64 .66
Reporting--Forms FDA 3210............ 49 2.10 30
Reporting--Forms FDA 3213, 3214...... 27 3.56 12
Reporting--Form FDA 3314............. 6 1.83 12.80
Recordkeeping--21 CFR 600.12......... 386 172 ........
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Estimate Total Annual Burden--72,229 hours.
7. Health Education Assistance loan (HEAL) Program--Request for
Collection Assistance--0915-0100 (Revision)--This form provides the
Department with data on delinquent borrowers. The Department uses the
information to assist the lenders in the collection of overdue
accounts, helping to ensure sound management of the HEAL Program.
Respondents: Businesses or other for-profit, Non-profit institutions;
Number of Respondents: 50; Number of Responses per Respondent: 340;
Average Burden per Response: .167 hour; Estimated Annual Burden: 2,833
hours.
8. Continuing Medical Education (CME) Activity Registration Forms--
New--The registration forms will be used to document physician
attendance at Continuing Medical Education activities required for
relicensing by state professional licensing boards. Respondents: State
or local governments, Businesses or other for-profit, Federal agencies
or employees, Non-profit institutions, Number of Respondents: 5,000;
Number of Responses per Respondent: 1; Average Burden per Response:
.0764 hour; 382 Estimated Annual Burden.
9. Patient and Physician Surveys Related to the Secondary and
Tertiary Prevention of Stroke: Patient Outcome Research Team (PORT)--
0935-0086 (Extension, no change)--Data are needed to study stroke
prevention activities and the related medical effectiveness and
outcomes of such activities. Physician practice patterns will be
assessed through a national probability sample mail survey of
physicians, and patients preferences will be assessed through a
telephone survey of stroke patients and persons at risk of stroke.
Respondents: Individuals or households' Number of Respondents: 3,052;
Number of Responses per Respondent: 1 hour; Average Burden per
Response: 0.388 hour; Estimated Annual Burden: 1,183 hours.
Written comments and recommendations concerning the proposed
information collections should be sent within 30 days of this notice
directly to the OMB Desk Officer designated below at the following
address:
Shannah Koss, Human Resources and Housing Branch, New Executive
Office Building, room 3002, Washington, DC 20503.
Dated: January 31, 1994.
James Scanlon,
Director, Division of Data Policy, Office of Health Planning and
Evaluation.
[FR Doc. 94-2542 Filed 2-3-94; 8:45 am]
BILLING CODE 4160-17-M
