[Federal Register Volume 61, Number 250 (Friday, December 27, 1996)]
[Notices]
[Pages 68268-68269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32882]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0487]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
January 27, 1997.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Geraldine M. Hogan, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1481.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the 
following proposed collection of information to OMB for review and 
clearance.
    Title: Current Good Manufacturing Practices for Blood and Blood 
Components; Notification of Consignees Receiving Blood and Blood 
Components at Increased Risk for Transmitting human immunodeficiency 
virus (HIV) Infection.
    Description: The final rule requires that blood establishments 
prepare and follow written procedures when the blood establishments 
have collected Whole Blood, blood components, Source Plasma and Source 
Leukocytes later determined to be at risk for transmitting HIV 
infections. This final rule requires that when a donor who previously 
donated blood is tested in accordance with 21 CFR 610.45 on a later 
donation, and tests repeatedly reactive for antibody to HIV, the blood 
establishment shall perform more specific testing using a licensed 
test, and notify consignees who received Whole Blood, blood components, 
Source Plasma or Source Leukocytes from prior collections so that 
appropriate action is taken. Blood establishments and consignees are 
required to quarantine previously collected Whole Blood, blood 
components, Source Plasma and Source Leukocytes from such donors, and 
if appropriate, notify transfusion recipients. The agency is issuing 
this final rule to help ensure the continued safety of the blood 
supply, to help ensure that information is provided to users of blood 
and blood components, and to help ensure that transfusion recipients of 
blood and blood components at risk for transmitting HIV will be 
notified as appropriate.
    Description of Respondents: Blood establishments (Business and Not-
for-Profit).
    The total estimated annual burden is 85,528 hours. FDA estimates 
the burden of this collection of information as follows:

                                  Estimated Annual Reporting/Disclosure Burden                                  
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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610.46(a)                           3,015              60         180,900                .17       30,753       
610.46(b)                           3,015              60         180,900                .17       30,753       
610.47(b)                             200              16           3,200                .5         1,600       
Total                             ..............  ..............  ..............  ..............   63,106       
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[[Page 68269]]


                                      Estimated Annual Recordkeeping Burden                                     
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
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606.100(b)(19)                      3,015               1           3,015               2           6,300       
606.160(b)(1)(vii)                    150             160          24,000              12.8         1,920       
606.160(b)(1)(viii)                 3,015              60         180,900               4.8        14,472       
Total                             ..............  ..............  ..............  ..............   22,422       
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There are no capital costs or operating and maintenance costs associated with this collection.                  


    Dated: December 20, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32882 Filed 12-26-96; 8:45 am]
BILLING CODE 4160-01-F