Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum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, 66366-66367 [2013-26397]
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Federal Register / Vol. 78, No. 214 / Tuesday, November 5, 2013 / Notices
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[FR Doc. 2013–26383 Filed 11–4–13; 8:45 am]
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[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Draft Guidance for Industry: Use of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
Food and Drug Administration,
HHS.
Notice.
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draft guidance document provides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 FDAlicensed, 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The draft guidance clarifies that FDA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:
SUMMARY:
PO 00000
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Total burden
hours
1
1
Food and Drug Administration
ACTION:
Average
burden hours
per response
54
54
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Number of
responses per
respondent
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 https://
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
E:\FR\FM\05NON1.SGM
05NON1
Federal Register / Vol. 78, No. 214 / Tuesday, November 5, 2013 / Notices
wreier-aviles on DSK5TPTVN1PROD with NOTICES
updated recommendations concerning
donor testing for evidence of T.
pallidum infection. HCT/P
Establishments must, as required under
§ 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 preamendment 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 § 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 TissueBased 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 https://
www.regulations.gov or written
VerDate Mar<15>2010
15:22 Nov 04, 2013
Jkt 232001
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 https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
66367
Name of Committee: National Institute of
General Medical Sciences Initial Review
Group; Training and Workforce Development
Subcommittee—B.
Date: November 22, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Arthur L. Zachary, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3An.12, Bethesda, MD
20892–4874, 301–594–2886, zacharya@
nigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: October 30, 2013.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–26435 Filed 11–4–13; 8:45 am]
National Institute of General Medical
Sciences; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Initial Review
Group; Training and Workforce Development
Subcommittee—A.
Date: November 21, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: John J. Laffan, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3An.18J, Bethesda, MD
20892–4874, 301–594–2773, laffanjo@
mail.nih.gov.
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BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Amended Notice
of Meeting
Notice is hereby given of a change in
the meeting of the Office of Research
Infrastructure Programs Special
Emphasis Panel, October 15, 2013, 08:00
a.m. to October 15, 2013, 05:30 p.m.,
National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD, 20892, which
was published in the Federal Register
on September 16, 2013, 78 FR 56903.
The meeting date is changed from
October 15, 2013 to November 14, 2013.
The meeting is closed to the public.
Dated: October 30, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–26414 Filed 11–4–13; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[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]
-----------------------------------------------------------------------
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 https://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 https://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 https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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
