[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
