[Federal Register: June 26, 2003 (Volume 68, Number 123)]
[Notices]
[Page 38083-38084]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn03-102]
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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 The draft guidance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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may also be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electronic access to the draft guidance document.
Submit written comments on the draft guidance to the Division of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