Document ID: FDA-2013-D-1213-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry:  Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis); Availability
Posted Date: 2013-11-05T05:00Z

[Federal Register Volume 78, Number 214 (Tuesday, November 5, 2013)]
[Notices]
[Pages 66366-66367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26397]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1213]

Draft Guidance for Industry: Use of Donor Screening Tests To Test 
Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products 
for Infection With Treponema pallidum (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: Use 
of Donor Screening Tests to Test Donors of Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps) for Infection with 
Treponema pallidum (Syphilis),'' dated October 2013. The draft guidance 
document provides establishments that make donor eligibility 
determinations for donors of HCT/Ps (HCT/P Establishments), with 
updated recommendations concerning donor testing for evidence of 
Treponema pallidum (T. pallidum) infection, the etiologic agent of 
syphilis. HCT/P Establishments must, as required under Federal 
regulations, test a donor specimen for evidence of T. pallidum 
infection using appropriate FDA-licensed, approved, or cleared donor 
screening tests, in accordance with the manufacturer's instructions, 
unless an exception to this requirement applies. The draft guidance 
clarifies that FDA does not consider diagnostic tests or pre-amendment 
devices (which have not been licensed, approved, or cleared) to be 
adequate for use in donor testing for T. pallidum infection under the 
criteria specified in Federal regulations. The recommendations in this 
guidance, when finalized, will supersede those recommendations for 
testing HCT/P donors for evidence of T. pallidum infection contained in 
the document entitled ``Guidance for Industry: Eligibility 
Determination for Donors of Human Cells, Tissues, and Cellular and 
Tissue-Based Products (HCT/Ps),'' dated August 2007.

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 February 3, 2014.

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: Use of Donor Screening Tests to Test Donors of 
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 
for Infection with Treponema pallidum (Syphilis),'' dated October 2013. 
The draft guidance document provides HCT/P Establishments with

[[Page 66367]]

updated recommendations concerning donor testing for evidence of T. 
pallidum infection. HCT/P Establishments must, as required under Sec.  
1271.80(a) and (c) (21 CFR 1271.80(a) and (c)), test a donor specimen 
for evidence of infection due to T. pallidum using appropriate FDA-
licensed, approved, or cleared donor screening tests, in accordance 
with the manufacturer's instructions, unless an exception to this 
requirement applies under 21 CFR 1271.90. The draft guidance clarifies 
that FDA does not consider diagnostic tests or pre-amendment devices 
(which have not been licensed, approved, or cleared) to be adequate for 
use in donor testing for T. pallidum infection under the criteria 
specified in Sec.  1271.80(c). FDA will no longer exercise enforcement 
discretion that permits the use of diagnostic syphilis tests or pre-
amendments devices for use as an HCT/P donor screening test because the 
wide availability of FDA-licensed, approved, or cleared test systems 
with an indication for use in donor screening no longer supports such 
enforcement discretion.
    In the Federal Register of February 28, 2007 (72 FR 9007), FDA 
announced the availability of the guidance entitled ``Guidance for 
Industry: Eligibility Determination for Donors of Human Cells, Tissues, 
and Cellular and Tissue-Based Products (HCT/Ps),'' dated February 2007. 
FDA issued a revised version of this guidance under the same title, 
dated August 2007 (hereafter referred to as the 2007 Donor Eligibility 
guidance). The draft guidance announced in this notice, when finalized, 
will supersede the recommendations for testing HCT/P donors for T. 
pallidum that were contained in the 2007 Donor Eligibility guidance.
    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. 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.

III. 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: October 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26397 Filed 11-4-13; 8:45 am]
BILLING CODE 4160-01-P