[Federal Register Volume 68, Number 123 (Thursday, June 26, 2003)]
[Notices]
[Pages 38083-38084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16241]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0236]


Draft ``Guidance for Industry: Revised Recommendations for Donor 
and Product Management Based on Screening Tests for Syphilis;'' 
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 draft document entitled ``Guidance for Industry: 
Revised Recommendations for Donor and Product Management Based on 
Screening Tests for Syphilis'' dated June 2003. The draft guidance 
document provides recommendations for testing donors of blood and blood 
components for syphilis, and for recommended actions based on those 
test results. The

[[Page 38084]]

recommendations described in the document are for blood establishments 
that use either nontreponemal-based or treponemal-based screening 
assays to test donors for serological evidence of syphilis infection. 
These recommendations, when finalized, will replace previous 
recommendations contained in a Memorandum to Registered Blood 
Establishments dated December 12, 1991.

DATES: Submit written or electronic comments on the draft guidance by 
September 24, 2003, to ensure their adequate consideration in 
preparation of the final guidance. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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, Rockville, 
MD 20852-1448. Send one self-addressed adhesive label to assist the 
office in processing your requests. The draft guidance may also be 
obtained by mail by calling the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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: Joseph L. Okrasinski, Jr., Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Revised Recommendations for Donor and Product 
Management Based on Screening Tests for Syphilis'' dated June 2003. The 
draft guidance document provides specific recommendations for donor 
testing and management, and product disposition when using screening 
tests for syphilis. The recommendations are for blood establishments 
that use either nontreponemal-based or treponemal-based screening 
assays for serological evidence of syphilis infection. These 
recommendations, when finalized, will replace the previous 
recommendations contained in a Memorandum to Registered Blood 
Establishments dated December 12, 1991.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance 
document represents the agency'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 requirement of the applicable statutes 
and regulations.

II. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft guidance. Submit 
written or electronic comments to ensure adequate consideration in 
preparation of the final 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 should be identified 
with the docket number found in brackets in the heading of this 
document. A copy of the draft 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.

III. Electronic Access

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

    Dated: June 18, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16241 Filed 6-25-03; 8:45 am]
BILLING CODE 4160-01-S