Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum, 54289-54290 [2015-22677]
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Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
to residents of Illinois with funding
from the Retirement Research
Foundation. Additional funds are
needed to leverage the foundation’s
funding, in order to ensure that the
current provision of services to Illinois
residents will be continued. This
supplementary funding would be
provided for the approved period.
Authority: This program is authorized
under Title II of the Older Americans Act
(OAA) (42 U.S.C. 3032), as amended by the
Older Americans Act Amendments of 2006,
Public Law 109–365.
(Catalog of Federal Domestic Assistance
93.048).
Dated: August 14, 2015.
Kathy Greenlee,
Assistant Secretary for Aging and
Administrator, Administration for
Community Living.
[FR Doc. 2015–22630 Filed 9–8–15; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Announcement of the Intent To Award
Single-Source Grants to the National
Association of Area Agencies on
Aging and the National Association of
States United for Aging and
Disabilities
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) announces the
intent to award, subject to the
availability of funds, single-source grant
awards in the amount of $335,000 to the
National Association of Area Agencies
on Aging (n4a) and $153,500 to the
National Association of State United for
Aging and Disabilities (NASUAD). The
awards will continue supporting and
stimulating the ongoing work by these
organizations to further develop and
assist states and community-based
organizations with building their
business capacity for managed longterm services and supports and delivery
system reform. CFDA Numbers: 93.048
DATES: The awards will be issued for a
project period of September 30, 2015
through September 29, 2016.
FOR FURTHER INFORMATION CONTACT:
Marisa Scala-Foley, Office of Integrated
Care Innovations, Administration for
Community Living, 1 Massachusetts
Avenue NW., Washington, DC 20001.
Telephone: 202–357–3516; Email:
Marisa.Scala-Foley@acl.hhs.gov.
Lhorne on DSK5TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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Jkt 235001
In 2012,
n4a and NASUAD were awarded grants
from ACL to build the business capacity
of state and community-based aging and
disability organizations for managed
long-term services and supports
(MLTSS). This one-year of grant
funding, through continuation grant,
will continue to support n4a and
NASUAD in their efforts to:
• Identify and track emerging trends,
best practices, barriers, lessons learned
and progress in the aging and disability
networks’ integration into MLTSS and
delivery system reform;
• increase state and community-based
aging and disability organizations’
capacity, readiness and involvement in
the provision of MLTSS through the
provision of broad-based and targeted
technical assistance, education and
training; and
• develop products that complement
and enhance the first two areas of focus.
This program is authorized under the
Older Americans Act of 1965, as
amended in 2006, Public Law 109–365.
SUPPLEMENTARY INFORMATION:
Dated: August 28, 2015.
Sharon Lewis,
Principal Deputy Administrator,
Administration for Community Living.
[FR Doc. 2015–22631 Filed 9–8–15; 8:45 am]
BILLING CODE 4154–01–P
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.
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
SUMMARY:
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54289
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 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 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 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, 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
E:\FR\FM\09SEN1.SGM
09SEN1
Lhorne on DSK5TPTVN1PROD with NOTICES
54290
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
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 § 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 FDAlicensed, 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
§ 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 FDAlicensed, 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 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 guidance announced in
this notice supersedes the
recommendations on compliance with
the requirements for testing HCT/P
donors for T. pallidum that are
VerDate Sep<11>2014
14:19 Sep 08, 2015
Jkt 235001
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 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 guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22677 Filed 9–8–15; 8:45 am]
sixth annual scientific workshop cosponsored by FDA and the Coalition
Against Major Diseases Consortium of
the Critical Path Institute, contained
incorrect Web links for online
registration and for the FDA Meeting
Information Page (where the workshop
agenda will be made available) and an
incorrect registration deadline. This
document corrects those errors.
FOR FURTHER INFORMATION CONTACT:
Jacqueline Brooks-Leighton, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 4521,
Silver Spring, MD 20993, 240–402–
5292, FAX: 301–796–9907, email:
jacqueline.brooks-leighton@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
2015–18969, appearing on page 45998,
in the Federal Register of Monday
August 3, 2015, the following
corrections are made:
On page 45998, in the second full
paragraph of the third column, the
registration link, https://
www.SignUp4.net/public/ap.aspx?EID=
SIXT10E, is corrected to read https://
www.cvent.com/events/6th-annualcoalition-against-major-diseases-foodand-drug-administration-scientificworkshop-public-/invitation-ed6c207
cbf09447185a891e4bf62ad7a.aspx?i=
70715ca1-f255-46b2-a3703fe3881bbab2.
On page 45998, in the third full
paragraph of the third column, the
registration deadline, October 14, 2015,
is corrected to read October 13, 2015.
On page 45998, in the third full
paragraph of the third column, the link
for the FDA Meeting information page,
https://www.fda.gov/Drugs/NewsEvents/
ucm410863.htm, is corrected to read
https://www.fda.gov/Drugs/NewsEvents/
ucm457486.htm.
BILLING CODE 4164–01–P
Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–22674 Filed 9–8–15; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2015–N–0001]
Sixth Annual Coalition Against Major
Diseases/Food and Drug
Administration Scientific Workshop;
Public Workshop; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of August 3, 2015 (80 FR
45998). That notice, announcing the
SUMMARY:
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Food and Drug Administration
[Docket No. FDA–2015–N–3015]
Use of Databases for Establishing the
Clinical Relevance of Human Genetic
Variants; Public Workshop; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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, 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 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 guidance at
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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