[Federal Register Volume 59, Number 130 (Friday, July 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16486]


[[Page Unknown]]

[Federal Register: July 8, 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, 
June 24, 1994.
    (Call PHS Reports Clearance Officer on 202-690-7100 for copies of 
request).
    1. Registration of Producers of Drugs and Listing of Drugs in 
Commercial Distribution--0910-0045 (Revision)--This revision 
incorporates the Food and Drug Administration's new regulation, 
``Imprinting of Solid Oral Dosage Form Drug Products for Human Use--
Final Rule.'' Information must be provided to insure agency regulatory 
action and surveillance of drug products. Information is also used to 
publish the NDC Directory which is used by the drug industry, third 
party reimbursement firms, insurance companies, and other government 
regulatory agencies.
    Respondents: Businesses or other for-profit; Small Businesses or 
organizations. 

------------------------------------------------------------------------
                                                Number of               
                                   Number of    responses     Average   
             Title                respondents      per       burden per 
                                               respondent     response  
                                                                        
------------------------------------------------------------------------
21 CFR, 207.25(c) Imprint--           1,500        12.04   .05 hour.    
 Reporting.                                                             
Currently Approved Reporting....     14,500         2.31   .50 hour.    
Currently Approved Recordkeeping     14,500          N/A   .039 hour.   
------------------------------------------------------------------------

    Estimated Total Annual Burden: 31,367 hours.
    2. Portable Self-Recording Flow-Meter in the Investigation of 
Occupational Airways Disorders--0920-0279 (Revision)--This submission 
is for extension of current approval for the National Institute of 
Occupational Safety and Health to test a newly developed portable self-
recording flow meter which may offer important advantages in the 
investigation of occupational asthma and acutely toxic or irritating 
environments. The new device offers investigators the potential for 
reducing the requirements for recording results while obtaining 
multiple, accurate and valid lung function measures before, during and 
after the workshift.
    Respondents: Individuals or households.

------------------------------------------------------------------------
                                                Number of               
                                   Number of    responses     Average   
             Title                respondents      per       burden per 
                                               respondent     response  
                                                                        
------------------------------------------------------------------------
Phase 1-5.......................        230            2   1.84 hours.  
Screener........................        275            1   .10 hour.    
------------------------------------------------------------------------

    Estimated Total Annual Burden: 873 hours.
    3. Health Education Assistance Loan (HEAL) Program Regulations--42 
CFR Part 60--0915-0108 (Revision)--These notification, reporting and 
recordkeeping requirements insure that the lenders, holders and schools 
participating in the HEAL program follow sound management procedures in 
the administration of federally-insured student loans.
    Respondents: Individuals or households; Businesses or other for-
profit; Non-profit institutions.

------------------------------------------------------------------------
                                                Number of               
                                   Number of    responses     Average   
             Title                respondents      per       burden per 
                                               respondent     response  
                                                                        
------------------------------------------------------------------------
Reporting.......................        351          1.9   2.5 hours.   
Notification....................     31,255         13.8   .25 hour.    
Recordkeeping...................        351        1,114   .19 hour.    
------------------------------------------------------------------------

    Estimated Total Annual Burden: 183,544 hour.
    4. Evaluation of the Ryan White Title IV HIV Demonstration Program 
for Children, Adolescents, and Families--New--Information needed to 
evaluate the Ryan White Title IV HIV Demonstration Program for 
Children, Adolescents, and Families will be collected from project 
staff and clients. Multiple data collection mechanisms will be used, 
including self-administered questionnaires (all 36 grantees), site 
visits to 18 grantees, and focus groups with clients at ten grantee 
sites.
    Respondents: Individuals or households; Non-profit institutions; 
Small businesses or organizations.

------------------------------------------------------------------------
                                                Number of               
                                   Number of    responses     Average   
             Title                respondents      per       burden per 
                                               respondent     response  
                                                                        
------------------------------------------------------------------------
Self-Study Guide................         36            1   4 hours.     
Site Visits.....................        180            1   3 hours.     
Focus Groups....................        120            1   3 hours.     
------------------------------------------------------------------------

    Estimated Total Annual Burden: 1,044 hours.
    5. Deferment Request Form for the National Health Service Corps and 
Native Hawaiian Health Scholarship Programs--New--Scholars 
participating in the National Health Service Corps or Native Hawaiian 
Health Scholarship Programs who wish to defer their service obligation 
in order to complete advanced training must submit information on the 
training program to the Secretary. This is a request for approval of 
the deferment form and associated requirements.
    Respondents: Individuals or households.

------------------------------------------------------------------------
                                                Number of               
                                   Number of    responses     Average   
              Title               respondents      per       burden per 
                                               respondent     response  
------------------------------------------------------------------------
Deferment Request Form..........        200            1   .5 hour.     
Associated Notification                  30            1   1 hour.      
 Requirements.                                                          
------------------------------------------------------------------------

    Estimated Total Annual Burden: 130 hours.
    6. Evaluation of Learning Needs in AETC Service Areas--New--AIDS 
Education and Training Centers (AETCs) are required, as a condition of 
award, to conduct an assessment of training needs in their service 
areas every three years. A standardized protocol has been developed for 
identifying training needs of physicians, physician assistants, nurses, 
certified nurse practitioners, dentists, and dental hygienists. 
Respondents: Individuals or households; Number of Respondents: 13,561; 
Number of Responses per Respondent: 1; Average Burden per Response: .19 
hour; Estimated Annual Burden: 2,557 hours.
    7. Responsibility of Applicants for Promoting Objectivity in 
Research for Which PHS Funding is Sought: 42 CFR Part 50 and 48 CFR 
Part 309--NPRM--New--The purpose of this rule is to protect the 
objectivity with which PHS-funded research is conducted. Disclosure of 
financial interests related to PHS-funded research by personnel who 
have decision making responsibilities that could affect the outcome of 
the research is required. The NPRM appeared in the Federal Register on 
June 28, 1994 (Vol. 59, No. 123, pp. 33242-33251). Respondents: 
Individuals or households; State or local governments; Businesses or 
other for-profit; Non-profit institutions; Small businesses or 
organizations; Estimated Annual Burden: 1 hour.
    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 10235, Washington, DC 20503.

    Dated: June 30, 1994.
James Scanlon,
Director, Division of Data Policy, Office of Health Planning and 
Evaluation.
[FR Doc. 94-16486 Filed 7-7-94; 8:45 am]
BILLING CODE 4160-17-M