[Federal Register Volume 64, Number 148 (Tuesday, August 3, 1999)]
[Notices]
[Pages 42132-42134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19794]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities: Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed collection extension of an existing collection 
of information, and to allow 60 days for public comment in response to 
the notice. This notice solicits comments on information collection 
provisions relating to the regulation of FDA's 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.

DATES: Submit written comments on the collection of information by 
October 4, 1999.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the

[[Page 42133]]

burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques when appropriate, and other forms of information technology.

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 Number 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 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 24,000,000 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, 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 notifications to consignees of subsequent 
test results. It is estimated that transfusion services not subject to 
HCFA 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, 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 42134]]



                                 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: July 27, 1999
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-19794 Filed 8-2-99; 8:45 am]
BILLING CODE 4160-01-F