[Federal Register Volume 60, Number 97 (Friday, May 19, 1995)]
[Notices]
[Pages 26892-26893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12256]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service


Agency Forms Undergoing Paperwork Reduction Act Review

    Each Friday the Public Health Service (PHS) publishes a list of 
information collection requests under review, in compliance with the 
Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of 
these requests, call the PHS Reports Clearance Office on (202) 690-
7100.
    The following requests have been submitted for review since the 
list was last published on May 12.
    1. Studies of Adverse Reproductive Outcomes in Female Occupational 
Groups--New--The reproductive health of a group of female workers 
exposed to a particular environmental chemical agent will be compared 
to the reproductive health of a group of working women with no 
occupational exposure to known or suspected reproductive toxicants. 
Respondents: Individuals or households; Business or other for-profit. 
Send comments to Shannah Koss, Human Resources and Housing Branch, New 
Executive Office Building, Room 10235, Washington, DC 20503.

                                                                        
[[Page 26893]]
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                                              No. of                    
                                  No. of     responses    Avg. burden/  
                               respondents      per         response    
                                            respondent                  
------------------------------------------------------------------------
Women........................      6,200            1   2.85 hours.     
Physicians...................      1,200            1   .5 hour.        
------------------------------------------------------------------------

Estimated Annual Burden: 18,250 hours.
    2. Infant Feeding Study Puberty Follow-up--0925-0381--Extension, no 
change--Children from a previous study of health effects of PCBs and 
DDE are being restudied to determine whether PCBs or DDE affect growth 
or pubertal development. Information is being collected annually from 
431 children and their parents to determine whether there is public 
health concern about these chemicals in children. Respondents: 
Individuals or households; Number of Respondents: 862; Number of 
Responses per Respondent: 1.1; Average Burden per Response: 0.23 hour; 
Estimated Annual Burden: 219 hours. Send comments to James Scanlon, 
Office of the Assistant Secretary for Health, Room 737-F, Humphrey 
Building, 200 Independence Ave., SW., Washington, DC 20201.
    3. FDA Recall Regulations--0910-0249--Extension, no change--Recall 
guidelines set forth procedures to be used by manufacturers and 
distributors or other responsible persons in notifying or alerting 
health professionals or other persons of an unreasonable risk of 
substantial harm to the public's health and describe the procedures 
used or required by FDA in the recall process. Respondents: Business or 
other for-profit. Send comments to Shannah Koss, Human Resources and 
Housing Branch, New Executive Office Building, Room 10235, Washington, 
DC 20503.

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                                                No. of                  
                                   No. of     responses/   Avg. burden/ 
                                respondents  respondents     response   
------------------------------------------------------------------------
21 CFR 7.42...................      1,294             1   1.8 hours.    
21 CFR 7.46/7.49..............      1,294             1   4 hours.      
21 CFR 7.53...................      1,294             1   36 hours.     
21 CFR 7.55(b)................      1,294             1   2 hours.      
------------------------------------------------------------------------

Estimated Annual Burden: 56,677 hours.
    Written Comments and recommendations concerning the proposed 
information collections should be sent within 30 days of this notice 
directly to the individual designated.

    Dated: May 12, 1995.
James Scanlon,
Director, Data Policy Staff, Office of the Assistant Secretary for 
Health and PHS Report Clearance Officer.
[FR Doc. 95-12256 Filed 5-18-95; 8:45 am]
BILLING CODE 4160-01-M