[Federal Register Volume 63, Number 54 (Friday, March 20, 1998)]
[Notices]
[Pages 13675-13676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7184]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0143]
``Guidance for Industry: Supplemental Testing and the
Notification of Consignees of Donor Test Results for Antibody to
Hepatitis C Virus (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 document entitled ``Guidance for Industry:
Supplemental Testing and the Notification of Consignees of Donor Test
Results for Antibody to Hepatitis C Virus (Anti-HCV).'' The guidance
document provides recommendations for donor screening and further
testing for antibody to HCV, notification of consignees, transfusion
recipient tracing and notification, and counseling by physicians
regarding transfusion with
[[Page 13676]]
blood components at increased risk for transmitting HCV. This guidance
is being issued in response to the recommendations of the Public Health
Service Advisory Committee on Blood Safety and Availability (PHS
Advisory Committee). This guidance supplements the July 19, 1996,
guidance document entitled ``Recommendations for the 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
document).
DATES: Written comments may be submitted at any time; however, comments
should be submitted by May 19, 1998, to ensure their adequate
consideration in preparation of any revision of the document.
ADDRESSES: Submit written requests for single copies of the guidance
entitled ``Guidance for Industry: Supplemental Testing and the
Notification of Consignees of Donor Test Results for Antibody to
Hepatitis C Virus (Anti-HCV),'' to the Office of Communication,
Training and Manufacturers Assistance (HFM-40), Center for Biologics
Evaluation and Research, 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 document may also
be obtained by mail or by calling the CBER Voice Information System at
1-800-835-4709 or 301-827-1800, or by fax 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. Submit written comments on the guidance document to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
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 at 301-496-0338.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Supplemental Testing and the Notification of
Consignees of Donor Test Results for Antibody to Hepatitis C Virus
(Anti-HCV).'' The guidance document provides recommendations for the
following: Further testing of donors who are repeatedly reactive for
antibody to HCV, quarantine of prior collections from such donors and
notification of consignees, recordkeeping, retrospective review of
records of donor testing following the implementation of a licensed
multi-antigen screening test for antibody to HCV, actions to be taken
following indeterminate test results, actions to be taken for donors
testing repeatedly reactive for antibody to HCV with no record of
additional testing for HCV, and transfusion recipient notification and
counseling by physicians. This guidance document supplements the July
1996 document, which provided recommendations for consignee
notification for the purpose of product quarantine and disposition of
prior collections from a donor who subsequently tests repeatedly
reactive for antibody to HCV. The July 1996 document did not provide
recommendations for the notification of recipients of such donations
because no clear consensus on the public health benefit had emerged at
that time.
The guidance is issued in response to recommendations from the PHS
Advisory Committee. The PHS Advisory Committee met on April 24 and 25,
1997, and August 11 and 12, 1997. Topics of discussion included the
improvements in the treatment and management of HCV infection, the
improvements in testing for antibody to HCV, and the public health
benefits of notification of transfusion recipients receiving prior
collections from a donor who subsequently tests repeatedly reactive for
antibody to HCV.
This guidance document represents the agency's current thinking
with regard to donor screening and further testing for antibody to HCV,
notification of consignees, transfusion recipient tracing and
notification, and counseling by physicians regarding transfusion with
blood components potentially contaminated with HCV. 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 OMB clearance under
the Paperwork Reduction Act of 1995. FDA will seek such approval and
provide an opportunity for public comment as appropriate.
II. Comments
This document is being distributed for comment purposes and for
implementation at this time. FDA has determined that under its good
guidance practices, that although this is a level 1 guidance document,
it should be implemented while comments are obtained due to the
recommendations providing further safeguards to the public health and
as recommended by the PHS Advisory Committee. Interested persons may
submit to the Dockets Management Branch (address above) written
comments regarding this guidance document. Written comments may be
submitted at any time, however, comments should be submitted by May 19,
1998, to ensure adequate consideration in preparation of any revision
of the document. Two copies of any comments are to be submitted, except
individuals may submit one copy. Comments and requests for copies
should be identified with the docket number found in the brackets in
the heading of this document. A copy of the guidance 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: March 4, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-7184 Filed 3-19-98; 8:45 am]
BILLING CODE 4160-01-F