[Federal Register Volume 78, Number 214 (Tuesday, November 5, 2013)]
[Notices]
[Pages 66366-66367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26397]
-----------------------------------------------------------------------
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Draft Guidance for Industry: Use of Donor Screening Tests To Test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.
-----------------------------------------------------------------------
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 The draft guidance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 The draft guidance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draft guidance before it begins work on the final version of the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