Sixth Annual Coalition Against Major Diseases/Food and Drug Administration Scientific Workshop; Public Workshop; Correction, 54290 [2015-22674]
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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the availability of the draft guidance of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received several comments on the draft
guidance and those comments were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the recommendations in the draft
guidance.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draft guidance dated October 2013.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]
[Page 54290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22674]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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.
-----------------------------------------------------------------------
SUMMARY: 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 sixth annual scientific workshop co-
sponsored 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-annual-coalition-against-major-diseases-food-and-drug-administration-scientific-workshop-public-/invitation-ed6c207cbf09447185a891e4bf62ad7a.aspx?i=70715ca1-f255-46b2-a370-3fe3881bbab2.
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.
Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22674 Filed 9-8-15; 8:45 am]
BILLING CODE 4164-01-P