[Federal Register Volume 63, Number 203 (Wednesday, October 21, 1998)]
[Notices]
[Pages 56198-56199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28217]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0814]
``Guidance for Industry: Current Good Manufacturing Practice for
Blood and Blood Components: (1) Quarantine and Disposition of Units
From Prior Collections From Donors With Repeatedly Reactive Screening
Test for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental
Testing, and the Notification of Consignees and Blood Recipients of
Donor Test Results for Anti-HCV;'' Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance document (dated September 1998) entitled
``Guidance for Industry: Current Good Manufacturing Practice for Blood
and Blood Components: (1) Quarantine and Disposition of Units From
Prior Collections From Donors With Repeatedly Reactive Screening Test
for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing,
and the Notification of Consignees and Blood Recipients of Donor Test
Results for Anti-HCV.'' The guidance document provides recommendations
for donor screening and supplemental testing for antibody to hepatitis
C virus (HCV), notification of consignees and quarantine of prior
collections from a donor who later tests repeatedly reactive for
antibody to HCV, notification of recipients of blood and blood
components at increased risk for transmitting HCV.
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the guidance
entitled ``Guidance for Industry: Current Good Manufacturing Practice
for Blood and Blood Components: (1) Quarantine and Disposition of Units
From Prior Collections From Donors With Repeatedly Reactive Screening
Test for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental
Testing, and the Notification of Consignees and Blood Recipients of
Donor Test Results for Anti-HCV'' to the Office of Communication,
Training, and Manufacturers Assistance (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed
adhesive label to assist the office in processing your requests. The
guidance document may also be obtained by mail by calling the CBER
Voice Information System at 1-800-835-4709 or 301-827-1800, or by
calling the Fax Information System at 1-888-CBER-FAX or 301-827-3844.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
Submit written comments on the guidance document to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Sharon A. Carayiannis, Center for Biologics Evaluation and Research
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448, 301-827-6210.
For technical/scientific questions, contact Robin M. Biswas, Center
for Biologics Evaluation and Research (HFM-325), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3011 or by FAX 301-496-0338.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Current Good Manufacturing Practice for Blood
and Blood Components: (1) Quarantine and Disposition of Units From
Prior Collections From Donors With Repeatedly Reactive Screening Test
for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing,
and the Notification of Consignees and Blood Recipients of Donor Test
Results for Anti-HCV.'' This guidance provides recommendations for the
following: (1) Quarantine (and release) of prior collections form
donors who later test repeatedly reactive for antibody to HCV; (2)
supplemental testing and notification of consignees and transfusion
recipients; (3) procedures and recordkeeping; (4) review of records of
donor testing for ``historical'' repeatedly reactive donations; (5)
quarantine (and release) of prior collections, notification of
consignees and transfusion recipients based on the review of records;
(6) additional testing following an indeterminate RIBA 2.0 test result;
and (7) additional testing of donors with no record of supplemental
testing on the ``historical'' repeatedly reactive screening test.
On March 20, 1998 (63 FR 13675), FDA announced the availability of
``Guidance for Industry: Supplemental Testing and the Notification of
Consignees of Donor Test Results for Antibody to Hepatitis C Virus
(Anti-HCV),'' (the March 1998 guidance). This guidance included a
recommendation that consignee notification should commence no later
than 6 months after date of issuance of the guidance, i.e., by
September 20, 1998.
On June 18, 1998, FDA made known at a public meeting of its Blood
Products Advisory Committee (BPAC) its intention to respond to public
comments received to the docket for the guidance by reissuance of a
comprehensive guidance on the same subject. At the BPAC meeting, FDA
announced it was considering changes to the ``HCV lookback'' policy,
including revision of recommendations for the additional testing of
donor samples and revision of FDA recommendations for implementation
timeframes. These changes were based on feasibility considerations
which had been raised by the public comments and evaluated by FDA.
During June and July 1998, FDA continued to receive extensive
public comments to the docket. These were reviewed and evaluated
carefully by CBER. CBER continued to work on modification of the
guidance. Although FDA intended to issue a revised guidance by the end
of July, the revision was delayed in order to incorporate additional
public comments that had been received.
Since FDA did not want to be in the position of having the guidance
in place with a compliance date that was being revised, the best
option, under the agency's Good Guidance Practices, was for FDA to
issue a notice to withdraw the current guidance pending issuance of
another comprehensive guidance. This withdrawal was posted on September
8, 1998. The guidance now being issued reflects the agency's current
position on this matter. This guidance supersedes FDA's March 1998
guidance. Additionally, this guidance supersedes the recommendations
related to HCV in FDA's July 19, 1996,
[[Page 56199]]
guidance entitled ``Recommendations for Quarantine and Disposition of
Units From Prior Collections From Donors With Repeatedly Reactive
Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
and Human T-Lymphotropic Virus Type I (HTLV-I)'' (the July 1996
guidance). This guidance does not supersede the recommendations related
to HBV and HTLV-I in the July 1996 guidance.
This guidance document represents the agency's current thinking
with regard to prior collections from donors testing repeatedly
reactive for antibody to HCV at a later date. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirement of the applicable statute, regulations, or
both. As with other guidance documents, FDA does not intend this
document to be all-inclusive and cautions that not all information may
be applicable to all situations. The document is intended to provide
information and does not set forth requirements.
This guidance document may contain collections of information that
require clearance under the Paperwork Reduction Act of 1995. FDA will
seek such approval and provide opportunity for comment as appropriate.
II. Comments
Interested persons, may at any time, submit written comments to
the Dockets Management Branch (address above) regarding this guidance
document. Two copies of any comments are to be submitted, except
individuals may submit one copy. Comments should be identified with the
docket number found in brackets in the heading of this document. A copy
of the document and received comments are available for public
examination in the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document using
the World Wide Web (WWW). For WWW access, connect to CBER at ``http://
www.fda.gov/cber/guidelines.htm''.
Dated: October 9, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-28217 Filed 10-20-98; 8:45 am]
BILLING CODE 4160-01-F