[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.

------------------------------------------------------------------------
                                                     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     ........
------------------------------------------------------------------------
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