[Federal Register Volume 64, Number 213 (Thursday, November 4, 1999)]
[Notices]
[Pages 60212-60213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28808]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-2250]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Current Good Manufacturing Practices for Blood 
and Blood Components; Notification of Consignees Receiving Blood and 
Blood Components at Increased Risk for Transmitting HIV Infection

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 
December 6, 1999.
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: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Current Good Manufacturing Practices for Blood and Blood 
Components; Notification of Consignees Receiving Blood and Blood 
Components at Increased Risk for Transmitting HIV Infection--21 CFR 
606.100, 606.160, 610.46, and 610.47 (OMB Control No. 0910-0336)--
Extension

    Under the biologics licensing and quarantine provisions of the 
Public Health Service Act (42 U.S.C. 262-264) and the general 
administrative provisions of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 351-353, 355-360, and 371-374), FDA has the authority to 
issue regulations designed to protect the public from unsafe or 
ineffective biological products and to issue regulations necessary to 
prevent the introduction, transmission, or spread of communicable 
diseases. FDA has implemented an extensive system of donor screening 
and testing procedures performed by blood establishments before, 
during, and after donation, to help prevent the transfusion of blood 
products that are at increased risk for transmitting human 
immunodeficiency virus (HIV). HIV is the virus that causes acquired 
immune deficiency syndrome (AIDS), a communicable disease that can be 
transmitted through transfusion. Despite the best practices of blood 
establishments, however, a person may donate blood early in infection, 
during the period when the antibody to HIV is not detectable by a 
screening test, but HIV is present in the donor's blood (a so-called 
``window'' period). If the donor attempts to donate blood at a later 
date, the test for antibody to HIV may, at that time, be repeatedly 
reactive. Therefore, FDA believes such circumstances require 
clarification of the donor's status through testing with a more 
specific antibody test and procedures to ``lookback'' at prior 
collections.
    FDA issued regulations that require blood establishments to follow 
written standard operating procedures (SOP's) when the blood 
establishments have collected Whole Blood, blood components, Source 
Plasma, and Source Leukocytes later determined to be at increased risk 
for transmitting HIV. When a donor who previously donated blood is 
tested on a later donation, and tests repeatedly reactive for antibody 
to HIV, the regulations require blood establishments to perform more 
specific testing using a licensed test, and notify consignees who 
received Whole Blood, blood components, Source Plasma, and Source 
Leukocytes from prior collections so that appropriate action is taken. 
Blood establishments and consignees are required to quarantine 
previously collection Whole Blood, blood components, Source Plasma, and 
Source Leukocytes from such donors, and if appropriate, notify 
transfusion recipients. Upon completion of more specific testing, 
hospital transfusion services that do not participate in Medicare, and 
are therefore not subject to Health Care Financing Administration's 
(HCFA's) regulations, are required to take steps to notify transfusion 
recipients, as appropriate. These regulations are intended to help 
ensure the continued safety of the blood supply by providing necessary 
information is provided to users of blood and blood components and 
appropriate notification of recipients of transfusion at increased risk 
for transmitting HIV infection.
    Section 606.100(b)(19) (21 CFR 606.100(b)(19)) requires written 
SOP's for the following procedures: (1) Review prior donations of blood 
and blood products from donors with no previous history of antibody to 
HIV who subsequently test repeatedly reactive for the antibody to HIV; 
(2) quarantine in-house blood and blood products; (3) notify consignees 
regarding the need to quarantine such products; (4) determine the 
suitability for release of such products from quarantine; (5) notify 
consignees of such products with antibody testing results from 
``lookback'' donors; and (6) notify attending physicians so that 
transfusion recipients are informed that they may have received blood 
and blood components at increased risk for transmitting HIV. Section 
606.160(b)(1)(vii) (21 CFR 606.160(b)(1)(vii)) requires records to 
relate the donor with the unit number of each previous donation from 
that donor. Section 606.160(b)(1)(viii) requires records of quarantine, 
notification, testing, and disposition performed under Secs. 610.46 and 
610.47 (21 CFR 610.46 and 610.47). Section 610.46(a) requires blood 
establishments to notify consignees, within 72 hours, of repeatedly 
reactive tests results so that previously collected blood and blood 
components are appropriately quarantined. Section 610.46(b) requires 
blood establishments to notify consignees of licensed, more specific 
test results for HIV within 30-calendar days after the donors's 
repeatedly reactive test. Section 610.47(b) requires transfusion 
services not subject to HCFA regulations to notify physicians of prior 
donation recipients or to notify recipients themselves of the need for 
HIV testing and counseling. There are approximately 3,076 registered 
blood establishments that annually collect an estimated 24 million 
units of Whole Blood and Source Plasma, and that are required to follow 
FDA ``lookback'' procedures. Of these establishments, approximately 180 
are registered transfusion services that are not subject to HCFA's 
``lookback'' regulations.
    The following reporting and recordkeeping estimates are based on 
information provided by industry, and FDA experience. In Table 1 of 
this document, it is estimated that an average of 60 repeat donors per 
establishment will test repeatedly reactive annually. This estimate 
results in a total number of 184,560 notifications of these test 
results to consignees by blood establishments for the purpose of 
quarantine of affected products, and another 184,560

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notifications to consignees of subsequent test results. It is estimated 
that transfusion services not subject to HCFA's regulations will need 
to notify physicians, or in some cases recipients, an average of 16 
times per year resulting in a total number of 2,880 notifications. FDA 
estimates an average of 10 minutes per notification of consignees, 
physicians, and recipients. The estimate of one-half hour for 
Sec. 610.47(b) is based on the minimum requirement of three attempts to 
notify recipients by transfusion services. In Table 2 of this document, 
the estimate of 154 recordkeepers and 160 records is based on the 
estimate that the requirement is already implemented voluntarily by 
more than 95 percent of the facilities, which collect 98 percent of the 
Nation's blood supply. FDA estimates that it takes approximately 5 
minutes to document and maintain the records to relate the donor with 
the unit number of each previous donation. The establishment of SOP's 
under Sec. 606.100(b)(19) is a one-time burden. The maintenance of the 
SOP's is considered usual and customary business practice, therefore no 
burden is calculated for the preparation and updating of the SOP.
    In the Federal Register of August 3, 1999 (64 FR 42132), the agency 
requested comments on the proposed collections of information. No 
significant comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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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)                           3,076              60         184,560               0.17       31,375
610.46(b)                           3,076              60         184,560               0.17       31,375
610.47(b)                             180              16           2,880               0.5         1,440
Total                                                                                              64,190
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden \1\
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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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606.160(b)(1)(vii)                    154             160          24,640              12.8         1,971
606.160(b)(1)(viii)                 3,076              60         184,560               4.8        14,765
Total                                                                                              16,736
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: October 27, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-28808 Filed 11-3-99; 8:45 am]
BILLING CODE 4160-01-F