Request for Nominations for Voting Members on a Public Advisory Committee; the Tobacco Products Scientific Advisory Committee, 50362-50363 [2021-19444]
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50362
Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Notices
Assistance Funding authorized by the
American Rescue Plan Act of 2021.
DATES: Comments due within 14 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above and below.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
submitted by emailing infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: ACF programs require
detailed financial information from their
grantees that allows ACF to monitor
various specialized cost categories
within each program, to closely manage
program activities, and to have
sufficient financial information to
enable periodic thorough and detailed
audits. The Generic Clearance for
Financial Reports used for ACF
Mandatory Grant Programs allows ACF
programs to efficiently develop and
receive approval for financial reports
that are tailored to specific funding
recipients and the associated needs of
the program. For more information
about the umbrella generic, see: https://
www.reginfo.gov/public/do/
PRAViewDocument?ref_nbr=2021080970-002.
This specific GenIC applies to all
state, territory, and tribal grantees
awarded TANF Pandemic Emergency
Assistance Funding as authorized by the
American Rescue Plan Act of 2021 (Pub.
L. 117–2). Section 403(c)(6)(A) of the
Social Security Act was augmented by
the passage of Public Law 117–2 with
this opportunity for funding to provide
non-recurrent, short term benefits and
associated administrative costs to
supplement, but not supplant, other
federal, state, tribal, territorial, or local
funds in meeting the emergency needs
of recipients. These federal funds will
serve as payment for expenditures
incurred from April 1, 2021, to
September 30, 2022, and if available,
any unspent funds will be reallotted and
available for expenditure for another 12
months.
All grantees must complete reporting
once a year in accordance with Office of
Family Assistance program policy
governing the administration of PEAF
Statute. The accompanying instructions
and terms and conditions of the grant
will provide guidance and assist
grantees with this requirement.
Respondents: States, Territories,
Tribes, and Tribal Consortia awarded
TANF Pandemic Emergency Assistance
Funding funds authorized by the
American Rescue Plan Act of 2021.
ANNUAL BURDEN ESTIMATES
Title of information collection
Number of
respondents
Annual
frequency
of responses
Hourly
burden per
response
Annual
hourly
burden
ACF–196P .......................................................................................................
137
1
6
822
Estimated Total Annual Burden
Hours: 822.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 14 days of this publication.
Authority: Pub. L. 117–2; Section
403(c)(6)(A) of the American Rescue
Plan Act of 2021.
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Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–19459 Filed 9–7–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
considered for nomination to the
committee as later vacancies occur.
Food and Drug Administration
ADDRESSES:
[Docket No. FDA–2018–N–3263]
Request for Nominations for Voting
Members on a Public Advisory
Committee; the Tobacco Products
Scientific Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for members to serve on
the Tobacco Products Scientific
Advisory Committee, in the Center for
Tobacco Products. FDA seeks to include
the views of women and men, members
of all racial and ethnic groups, and
individuals with and without
disabilities on its advisory committees
and, therefore encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Nominations received on or
before November 8, 2021 will be given
first consideration for membership on
the Tobacco Products Scientific
Advisory Committee. Nominations
received after November 8, 2021 will be
SUMMARY:
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All nominations for
membership should be sent
electronically by logging into the FDA
Advisory Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm.
Information about becoming a member
on an FDA advisory committee can also
be obtained by visiting FDA’s website
by using the following link: https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, the primary contact is:
Serina Hunter-Thomas, Office of
Science, Center for Tobacco Products,
Food and Drug Administration, Center
for Tobacco Products, Document
Control Center, Bldg. 71, Rm. G335,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 1–877–287–
1373 (choose Option 5), email: TPSAC@
fda.hhs.gov.
FDA is
requesting nomination for voting
members on the Tobacco Products
Scientific Advisory Committee.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Notices
I. General Description of the Committee
Duties
The Tobacco Products Scientific
Advisory Committee (the Committee)
advises the Commissioner of FDA (the
Commissioner) or designee in
discharging responsibilities related to
the regulation of tobacco products. The
Committee reviews and evaluates
behavior, dependence, and health
issues, among others, relating to tobacco
products and provides appropriate
advice, information, and
recommendations to the Commissioner.
Dated: September 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
II. Criteria for Voting Members
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Committee shall consist of 12
members, including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
individuals knowledgeable in the fields
of science, medicine, medical ethics, or
technology involving the manufacture,
evaluation, or use of tobacco products.
Almost all non-Federal members of this
committee serve as Special Government
Employees. The Committee shall
include nine technically qualified
voting members, selected by the
Commissioner or designee. The nine
voting members shall be scientists,
physicians, dentists, or healthcare
professionals practicing in the areas of
oncology, pulmonology, cardiology,
toxicology, pharmacology, addiction,
epidemiology, behavioral health, or any
other relevant specialty. One member
shall be an officer or employee of a state
or local government or of the Federal
Government. The final voting member
shall be a representative of the general
public. Members will be invited to serve
for terms of up to 4 years.
III. Nomination Procedures
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contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Any interested person may nominate
one or more qualified individuals for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will ask
potential candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
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Food and Drug Administration
[Docket No. FDA–2019–N–5464]
Center for Drug Evaluation and
Research Office of New Drugs Novel
Excipient Review Pilot Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA) Center for Drug
Evaluation and Research (CDER) is
announcing a Novel Excipient Review
Pilot Program (Pilot Program). The Pilot
Program is voluntary and intended to
allow excipient manufacturers to obtain
FDA review of certain novel excipients
prior to their use in drug formulations.
The Pilot Program seeks to foster
development of excipients that may be
useful in scenarios in which excipient
manufacturers and drug developers
have cited difficulty in using existing
excipients.
DATES: FDA is seeking initial proposals
for the voluntary Novel Excipient
Review Pilot Program through December
7, 2021.
FOR FURTHER INFORMATION CONTACT:
Felecia Wilson, Center for Drug
Evaluation and Research, Food and
Drug Administration, Novel-ExcipientProgram@fda.hhs.gov, 301–796–9590.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Excipient manufacturers and drug
developers have cited product
development challenges related to the
use of certain excipients (also known as
inactive ingredients), including issues
related to formulation and stability.
Novel excipients might be able to
address some of these issues and
provide additional public health
benefits, such as enhanced drug
bioavailability, more comfortable drug
administration, new abuse-deterrent
opioid formulations, new routes of drug
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50363
delivery, and facilitation of new
technologies. However, drug developers
report that they have been hesitant to
use novel excipients in drug
development programs due to the
uncertainty surrounding their
acceptability.
To address these issues, FDA issued
a request for information in the Federal
Register on December 5, 2019 (84 FR
66669), seeking comment on a potential
pilot program for FDA review of novel
excipients. FDA received several
comments to the public docket on these
issues. After considering these
comments, CDER has decided to
establish this Pilot Program.
A. Scope
For purposes of the Pilot Program, an
excipient is any ingredient intentionally
added to a drug product (including a
biological drug product) that is not
intended to exert therapeutic effects at
the intended dosage, although it may
improve product delivery (see FDA
guidance for industry entitled
‘‘Nonclinical Studies for the Safety
Evaluation of Pharmaceutical
Excipients’’ (Ref.1)). Examples of
excipients may include fillers,
extenders, diluents, surfactants,
solvents, emulsifiers, preservatives,
flavors, absorption enhancers, modified
release matrices, and coloring agents.
Also, for purposes of this Pilot Program,
a novel excipient is any excipient that
is not fully supported by existing safety
data with respect to the currently
proposed level of exposure, duration of
exposure, or route of administration
(Ref. 1). This parallels the definition of
‘‘new excipients’’ defined in Ref. 1.
CDER proposes a more limited scope
for this Pilot Program. The Pilot
Program will initially be available for
novel excipients that (1) have not been
previously used in FDA-approved drug
products, and (2) do not have an
established use in food. CDER
recognizes that there may be novel
excipients not meeting this scope that
may also address product development
challenges or provide public health
benefits. However, because of the
limited scope of the initial phase of the
Pilot Program (described further below),
CDER will not be able to consider
submissions for all kinds of novel
excipients. CDER may expand the scope
of the Pilot Program in the future
depending on its success and as
resources allow.
The Pilot Program is voluntary.
Existing processes for developing
excipients for use in drug and biological
products continue to be available.
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Agencies
[Federal Register Volume 86, Number 171 (Wednesday, September 8, 2021)]
[Notices]
[Pages 50362-50363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19444]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3263]
Request for Nominations for Voting Members on a Public Advisory
Committee; the Tobacco Products Scientific Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for members to serve on the Tobacco Products Scientific
Advisory Committee, in the Center for Tobacco Products. FDA seeks to
include the views of women and men, members of all racial and ethnic
groups, and individuals with and without disabilities on its advisory
committees and, therefore encourages nominations of appropriately
qualified candidates from these groups.
DATES: Nominations received on or before November 8, 2021 will be given
first consideration for membership on the Tobacco Products Scientific
Advisory Committee. Nominations received after November 8, 2021 will be
considered for nomination to the committee as later vacancies occur.
ADDRESSES: All nominations for membership should be sent electronically
by logging into the FDA Advisory Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm.
Information about becoming a member on an FDA advisory committee can
also be obtained by visiting FDA's website by using the following link:
https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership, the primary contact is: Serina Hunter-Thomas, Office of
Science, Center for Tobacco Products, Food and Drug Administration,
Center for Tobacco Products, Document Control Center, Bldg. 71, Rm.
G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-
287-1373 (choose Option 5), email: [email protected].
SUPPLEMENTARY INFORMATION: FDA is requesting nomination for voting
members on the Tobacco Products Scientific Advisory Committee.
[[Page 50363]]
I. General Description of the Committee Duties
The Tobacco Products Scientific Advisory Committee (the Committee)
advises the Commissioner of FDA (the Commissioner) or designee in
discharging responsibilities related to the regulation of tobacco
products. The Committee reviews and evaluates behavior, dependence, and
health issues, among others, relating to tobacco products and provides
appropriate advice, information, and recommendations to the
Commissioner.
II. Criteria for Voting Members
The Committee shall consist of 12 members, including the Chair.
Members and the Chair are selected by the Commissioner or designee from
among individuals knowledgeable in the fields of science, medicine,
medical ethics, or technology involving the manufacture, evaluation, or
use of tobacco products. Almost all non-Federal members of this
committee serve as Special Government Employees. The Committee shall
include nine technically qualified voting members, selected by the
Commissioner or designee. The nine voting members shall be scientists,
physicians, dentists, or healthcare professionals practicing in the
areas of oncology, pulmonology, cardiology, toxicology, pharmacology,
addiction, epidemiology, behavioral health, or any other relevant
specialty. One member shall be an officer or employee of a state or
local government or of the Federal Government. The final voting member
shall be a representative of the general public. Members will be
invited to serve for terms of up to 4 years.
III. Nomination Procedures
Any interested person may nominate one or more qualified
individuals for membership on the advisory committee. Self-nominations
are also accepted. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address and/or home address, telephone number, and
email address if available and a signed copy of the Acknowledgement and
Consent form available at the FDA Advisory Nomination Portal (see
ADDRESSES). Nominations must also specify the advisory committee for
which the nominee is recommended. Nominations must also acknowledge
that the nominee is aware of the nomination unless self-nominated. FDA
will ask potential candidates to provide detailed information
concerning such matters related to financial holdings, employment, and
research grants and/or contracts to permit evaluation of possible
sources of conflicts of interest.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: September 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19444 Filed 9-7-21; 8:45 am]
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