Document ID: FDA-2003-D-0128-0004
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry; Recommendations for Screening, Testing, and, Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis; Aavailability
Posted Date: 2013-02-26T05:00Z

[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13069-13070]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04281]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2003-D-0128] (formerly 2003D-0236)

Draft Guidance for Industry: Recommendations for Screening, 
Testing, and, Management of Blood Donors and Blood and Blood Components 
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: 
Recommendations for Screening, Testing, and Management of Blood Donors 
and Blood and Blood Components Based on Screening Tests for Syphilis,'' 
dated March 2013. The draft guidance document provides revised 
recommendations for screening and testing of donors and management of 
donations based on screening tests for syphilis. The draft guidance is 
intended for blood establishments that collect Whole Blood or blood 
components, including Source Plasma. The guidance announced in this 
notice replaces the draft guidance entitled, ``Guidance for Industry: 
Revised Recommendations for Donor and Product Management Based on 
Screening Tests for Syphilis,'' dated June 2003. In addition, the draft 
guidance, when finalized, is intended to supersede the FDA memorandum 
to registered blood establishments dated December 12, 1991, entitled, 
``Clarification of FDA Recommendations for Donor Deferral and Product 
Distribution Based on the Results of Syphilis Testing.''

[[Page 13070]]

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 28, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-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 draft 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 draft 
guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft document entitled, 
``Guidance for Industry: Recommendations for Screening, Testing, and 
Management of Blood Donors and Blood and Blood Components Based on 
Screening Tests for Syphilis,'' dated March 2013. The draft guidance 
document provides revised recommendations for screening and testing of 
donors and management of donations based on screening tests for 
syphilis. The recommendations described in the document are for blood 
establishments that use either non-treponemal or treponemal screening 
assays to test donors for serological evidence of syphilis infection.
    In the Federal Register of June 26, 2003 (68 FR 38083), FDA 
announced the availability of the draft guidance entitled, ``Guidance 
for Industry: Revised Recommendations for Donor and Product Management 
Based on Screening Tests for Syphilis,'' dated June 2003. The draft 
guidance announced in this notice replaces the 2003 draft guidance and 
when finalized, is intended to supersede the FDA memorandum to all 
registered blood establishments dated December 12, 1991, entitled, 
``Clarification of FDA Recommendations for Donor Deferral and Product 
Distribution Based on the Results of Syphilis Testing.''
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This draft 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 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 630.6 and 606.160 have been 
approved under OMB control number 0910-0116.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04281 Filed 2-25-13; 8:45 am]
BILLING CODE 4160-01-P