Meeting Notice for the President's Advisory Council on Faith-Based and Neighborhood Partnerships, 72976 [2015-29826]
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Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Over-the-Counter Sunscreens: Safety
and Effectiveness Data.’’ This draft
guidance addresses FDA’s current
thinking regarding the safety and
effectiveness data needed to determine
whether a nonprescription sunscreen
active ingredient or combination of
active ingredients evaluated under the
SIA is GRASE and not misbranded
when used under specified conditions.
The guidance also addresses FDA’s
current thinking about an approach to
safety-related final formulation testing
that it anticipates adopting in the future.
FDA is issuing this guidance in partial
implementation of the SIA (Pub. L. 113–
195), enacted November 26, 2014,
which amended the Federal Food, Drug,
and Cosmetic Act (the FD&C Act).
Among other things, the SIA established
new procedures and review time lines
for FDA to determine whether a
nonprescription sunscreen active
ingredient or combination of active
ingredients is GRASE and not
misbranded when used under the
conditions specified in a final sunscreen
order (GRASE determination) (21 U.S.C.
360fff–1, –2, and –3). The SIA also
directed FDA to issue four guidances on
various topics, including this guidance
(21 U.S.C. 360ffff–4). Many of the safety
topics addressed in this guidance were
discussed at a public Nonprescription
Drug Advisory Committee meeting held
September 4 and 5, 2014 (https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
NonprescriptionDrugsAdvisory
Committee/ucm380890.htm).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Over-the-Counter Sunscreens:
Safety and Effectiveness Data; Draft
Guidance for Industry; Availability.’’ 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.
wgreen on DSK2VPTVN1PROD with NOTICES
II. The Paperwork Reduction Act of
1995
This guidance contains collections of
information that are exempt from the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520). Section
586D(a)(1)(C) of the FD&C Act (21
U.S.C. 360fff–4(a)(1)(C)) as amended by
the SIA states that the PRA shall not
apply to collections of information
VerDate Sep<11>2014
14:25 Nov 20, 2015
Jkt 238001
made for purposes of guidance under
that subsection.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: November 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–29636 Filed 11–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting Notice for the President’s
Advisory Council on Faith-Based and
Neighborhood Partnerships
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the President’s
Advisory Council on Faith-based and
Neighborhood Partnerships announces
the following webinar:
Name: President’s Advisory Council
on Faith-based and Neighborhood
Partnerships Council Meetings.
Time and Date: Wednesday,
December 9th, 2015 3:00 p.m.–4:30 p.m.
(EST).
Public Webinar: The meeting will be
available to the public through a
webinar system. Register to participate
in the conference call on Wednesday,
December 9th at the Web site https://
attendee.gotowebinar.com/register/
831474153301651458.
Status: Open to the public, limited
only by space available. Conference call
limited only by lines available.
Purpose: The Council brings together
leaders and experts in fields related to
the work of faith-based and
neighborhood organizations in order to:
Identify best practices and successful
modes of delivering social services;
evaluate the need for improvements in
the implementation and coordination of
public policies relating to faith-based
and other neighborhood organizations;
and make recommendations for changes
in policies, programs, and practices. The
charge for this Council focuses on steps
the government should take to reduce
poverty and inequality and create
opportunity for all, including changes in
policies, programs, and practices that
affect the delivery of services by faithbased and community organizations and
the needs of low-income and other
underserved persons.
Contact Person for Additional
Information: Please contact Ben O’Dell
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
for any additional information about the
President’s Advisory Council meeting at
partnerships@hhs.gov.
Agenda: Opening and Welcome from
the Chairperson and Executive Director
for the President’s Advisory Council for
Faith-based and Neighborhood
Partnership; Updates for three working
groups; Deliberation of
recommendations (if necessary);
Conclusion from Chairperson and
Executive Director.
Public Comment: There will be an
opportunity for public comment at the
end of the meeting. Comments and
questions can be sent in advance to
partnerships@hhs.gov.
Dated: November 17, 2015.
Ben O’Dell,
Associate Director for Center for Faith-based
and Neighborhood Partnerships at U.S.
Department of Health and Human Services.
[FR Doc. 2015–29826 Filed 11–20–15; 8:45 am]
BILLING CODE 4154–07–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Heart, Lung,
and Blood Institute Special Emphasis
Panel, December 7, 2015, 8:00 a.m.
through December 8, 2015, 5:00 p.m.,
The William F. Bolger Center, 9600
Newbridge Drive, Potomac, MD, 20854
which was published in the Federal
Register on November 12, 2015, 2015–
28656.
Dr. Joyce’s December 7–8, 2015 ZHL1
meeting has been rescheduled to
January 4–5, 2016, at 8:00 a.m. The
meeting is closed to the public.
Dated: November 17, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–29735 Filed 11–20–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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
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[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Notices]
[Page 72976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29826]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting Notice for the President's Advisory Council on Faith-
Based and Neighborhood Partnerships
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the President's Advisory Council on
Faith-based and Neighborhood Partnerships announces the following
webinar:
Name: President's Advisory Council on Faith-based and Neighborhood
Partnerships Council Meetings.
Time and Date: Wednesday, December 9th, 2015 3:00 p.m.-4:30 p.m.
(EST).
Public Webinar: The meeting will be available to the public through
a webinar system. Register to participate in the conference call on
Wednesday, December 9th at the Web site https://attendee.gotowebinar.com/register/831474153301651458.
Status: Open to the public, limited only by space available.
Conference call limited only by lines available.
Purpose: The Council brings together leaders and experts in fields
related to the work of faith-based and neighborhood organizations in
order to: Identify best practices and successful modes of delivering
social services; evaluate the need for improvements in the
implementation and coordination of public policies relating to faith-
based and other neighborhood organizations; and make recommendations
for changes in policies, programs, and practices. The charge for this
Council focuses on steps the government should take to reduce poverty
and inequality and create opportunity for all, including changes in
policies, programs, and practices that affect the delivery of services
by faith-based and community organizations and the needs of low-income
and other underserved persons.
Contact Person for Additional Information: Please contact Ben
O'Dell for any additional information about the President's Advisory
Council meeting at partnerships@hhs.gov.
Agenda: Opening and Welcome from the Chairperson and Executive
Director for the President's Advisory Council for Faith-based and
Neighborhood Partnership; Updates for three working groups;
Deliberation of recommendations (if necessary); Conclusion from
Chairperson and Executive Director.
Public Comment: There will be an opportunity for public comment at
the end of the meeting. Comments and questions can be sent in advance
to partnerships@hhs.gov.
Dated: November 17, 2015.
Ben O'Dell,
Associate Director for Center for Faith-based and Neighborhood
Partnerships at U.S. Department of Health and Human Services.
[FR Doc. 2015-29826 Filed 11-20-15; 8:45 am]
BILLING CODE 4154-07-P
