Document ID: FDA-2013-D-1213-0010
Agency: fda
Document Type: Notice
Title: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis); Guidance for Industry; Availability
Posted Date: 2015-09-09T04:00Z

[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54289-54290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22677]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Use of Donor Screening Tests To Test Donors of Human Cells, 
Tissues, and Cellular and Tissue-Based Products for Infection With 
Treponema pallidum (Syphilis); Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a document entitled ``Use of Donor Screening Tests 
to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based 
Products for Infection with Treponema pallidum (Syphilis); Guidance for 
Industry.'' The guidance document provides establishments that make 
donor eligibility determinations for donors of human cells, tissues, 
and cellular and tissue-based products (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 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 guidance announced in this notice 
finalizes the draft guidance of the same title, dated October 2013. The 
recommendations in the guidance announced in this notice supersedes 
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: 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 240-402-8010. 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, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a document entitled ``Use of 
Donor Screening Tests to Test Donors of

[[Page 54290]]

Human Cells, Tissues and Cellular and Tissue-Based Products for 
Infection with Treponema pallidum (Syphilis); Guidance for Industry.'' 
The guidance document provides HCT/P Establishments with 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 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. FDA recommends that HCT/P Establishments 
implement the recommendations in the guidance as soon as feasible, but 
not later than 6 months after issuance of this guidance.
    In the Federal Register of November 5, 2013 (78 FR 66366), FDA 
announced the availability of the draft guidance of the same title, 
dated October 2013. FDA received several comments on the draft guidance 
and those comments were considered as the guidance was finalized. FDA 
did not make changes to the recommendations in the draft guidance. FDA 
made editorial changes to improve clarity. The guidance announced in 
this notice finalizes the draft guidance dated October 2013.
    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 guidance announced in this notice supersedes the 
recommendations on compliance with the requirements for testing HCT/P 
donors for T. pallidum that are contained in the 2007 Donor Eligibility 
guidance.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Use of Donor Screening Tests to Test 
Donors of Human Cells, Tissues and Cellular and Tissue-Based Products 
for Infection with Treponema pallidum (Syphilis); Guidance for 
Industry.'' It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. 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.

III. 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: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22677 Filed 9-8-15; 8:45 am]
 BILLING CODE 4164-01-P