Document ID: FDA-2003-D-0128-0011
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Recommendations for Screening,
Testing, and Management of Blood Donors and Blood and Blood
Components Based on Screening Tests for Syphilis; Availability
Posted Date: 2014-08-28T04:00Z

[Federal Register Volume 79, Number 167 (Thursday, August 28, 2014)]
[Notices]
[Pages 51341-51342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20483]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2003-D-0128 (Legacy ID: FDA-2003D-0236)]

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 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 September 2014. The guidance document provides recommendations 
for screening and testing of donors and management of donations based 
on screening tests for syphilis. The guidance is intended for blood 
establishments that collect Whole Blood or blood components, including 
Source Plasma. The guidance announced in this notice finalizes the 
draft guidance of the same title, dated March 2013 (2013 draft 
guidance), and supersedes the memorandum of December 12, 1991, entitled 
``Clarification of FDA Recommendations for Donor Deferral and Product 
Distribution Based on the Results of Syphilis Testing.''

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

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. 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 240-402-7800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the 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, Food and Drug Administration, 
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, 
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a 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 September 2014. The guidance 
document provides recommendations for screening and testing of donors 
and management of

[[Page 51342]]

donations based on screening tests for syphilis. The recommendations 
described in the document are for blood establishments that use either 
nontreponemal or treponemal screening assays to test donors for 
serological evidence of syphilis infection.
    In the Federal Register of February 26, 2013 (78 FR 13069), FDA 
announced the availability of the 2013 draft guidance. FDA received 
several comments on the 2013 draft guidance and those comments were 
considered as the guidance was finalized. In summary, FDA modified the 
recommendations provided in the 2013 draft guidance concerning the use 
of an FDA-cleared nontreponemal donor screening assay to test donations 
from reentered donors. In addition, FDA made editorial changes to 
recommendations in the guidance to improve clarity. The guidance 
announced in this notice finalizes the 2013 draft guidance.
    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 
requirement 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 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 601.12 have been approved under 
OMB control number 0910-0338; and 21 CFR 606.121, 606.160, 610.40, 
630.6, 640.3, 640.65, and 640.71 have been approved under OMB control 
number 0910-0116.

III. Comments

    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 guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-20483 Filed 8-27-14; 8:45 am]
BILLING CODE 4164-01-P