[Federal Register Volume 72, Number 164 (Friday, August 24, 2007)]
[Notices]
[Pages 48658-48659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999D-1878 (formerly Docket No. 99D-1878)]


``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): 
Product Quarantine, Consignee Notification, Further Testing, Product 
Disposition, and Notification of Transfusion Recipients Based on Donor 
Test Results Indicating Infection with 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: `Lookback' 
for Hepatitis C Virus (HCV): Product Quarantine, Consignee 
Notification, Further Testing, Product Disposition, and Notification of 
Transfusion Recipients Based on Donor Test Results Indicating Infection 
with HCV,'' dated August 2007. The guidance document provides 
recommendations for complying with the HCV ``Lookback'' requirements. 
This guidance document finalizes the guidance entitled, ``Draft 
Guidance for Industry: Current Good Manufacturing Practice for Blood 
and

[[Page 48659]]

Blood Components: (1) Quarantine and Disposition of Prior Collections 
from Donors with Repeatedly Reactive Screening Tests for Hepatitis C 
Virus (HCV); (2) Supplemental Testing, and the Notification of 
Consignees and Transfusion Recipients of Donor Test Results for 
Antibody to HCV (Anti-HCV)'' dated June 1999. Additionally, this 
guidance document supersedes the HCV sections of the FDA memorandum 
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),'' dated July 19, 1996; and also 
supersedes the 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 Tests 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'' 
dated September 1998.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule entitled ``Current Good Manufacturing Practice for Blood 
and Blood Components; Notification of Consignees and Transfusion 
Recipients Receiving Blood and Blood Components at Increased Risk of 
Transmitting Hepatitis C Virus Infection (`Lookback').''

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 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, suite 200N, Rockville, MD 
20852-1448. Send one self-addressed adhesive label to assist the office 
in processing your requests. The guidance may also be obtained by mail 
by calling CBER at 1-800-835-4709 or 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): 
Product Quarantine, Consignee Notification, Further Testing, Product 
Disposition, and Notification of Transfusion Recipients Based on Donor 
Test Results Indicating Infection with HCV,'' dated August 2007. The 
guidance document provides recommendations to blood collecting 
establishments, hospitals, and other consignees for appropriate action 
when a repeat donor subsequently tests repeatedly reactive for HCV 
using either a single antigen or multiantigen screening test, or 
reactive using a direct viral detection test, e.g., HCV ribonucleic 
acid (RNA) nucleic acid tests (NAT). This procedure is commonly 
referred to as HCV ``lookback.'' The guidance document provides 
guidance for the following:
     Quarantining of prior collections that remain in 
inventory;
     Notifying consignees to quarantine prior collections;
     Further testing of the donor;
     Destroying or labeling potentially infectious prior 
collections; and
     Notifying transfusion recipients who received blood from a 
donor who is later determined to be infected with HCV, if appropriate.
    This guidance document finalizes the guidance entitled, ``Draft 
Guidance for Industry: Current Good Manufacturing Practice for Blood 
and Blood Components: (1) Quarantine and Disposition of Prior 
Collections from Donors with Repeatedly Reactive Screening Tests for 
Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification 
of Consignees and Transfusion Recipients of Donor Test Results for 
Antibody to HCV (Anti-HCV)'' dated June 1999. Additionally, this 
guidance document supersedes the HCV sections of the FDA memorandum 
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),'' dated July 19, 1996; and also 
supersedes 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 Tests 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'' 
dated September 1998.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on this topic. 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 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1955 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 606.121, and 610.40 have been 
approved under OMB control number 0910-0116; the collections of 
information in 21 CFR 610.47 and 610.48 have been approved under OMB 
control number 0910-0460; and the collections of information in 21 CFR 
640.70 have been approved under OMB control number 0910-0338.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding this guidance. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except that individuals may 
submit one paper copy. Comments are to be identified with the docket 
number found in the brackets in the heading of this document. A copy of 
the guidance and received comments are available for public examination 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: July 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16605 Filed 8-23-07; 8:45 am]
BILLING CODE 4160-01-S