[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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