[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]


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

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.

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

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