[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