Request for Nominations of a Nonvoting Representative of the Interest of the Tobacco Manufacturing Industry on the Tobacco Products Scientific Advisory Committee, 55575-55576 [2019-22683]
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Federal Register / Vol. 84, No. 201 / Thursday, October 17, 2019 / Notices
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, the primary contact is:
Janice O’Connor, Office of Science,
Center for Tobacco Products, Food and
Drug Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993–0002, 1–877–287–1373 (choose
Option 5), email: TPSAC@fda.hhs.gov.
Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
website at: https://www.fda.gov/
AdvisoryCommittees/default.htm.
SUPPLEMENTARY INFORMATION: FDA is
requesting nomination for voting
members on the Tobacco Products
Scientific Advisory Committee.
I. General Description of the Committee
Duties
The Tobacco Products Scientific
Advisory Committee advises the
Commissioner of Food and Drugs (the
Commissioner) or designee in
discharging responsibilities related to
the regulation of tobacco products. The
committee reviews and evaluates safety,
dependence, or health issues relating to
tobacco products and provides
appropriate advice, information, and
recommendations to the Commissioner.
II. Criteria for Voting Members
The committee consists 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 medicine, medical ethics, science, 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 includes
nine technically qualified voting
members, selected by the Commissioner
or designee. The nine voting members
include seven members who are
physicians, dentists, scientists, or
healthcare professionals practicing in
the areas of oncology, pulmonology,
cardiology, toxicology, pharmacology,
addiction, or any other relevant
specialty. The nine voting members also
include one member who is an officer
or employee of a State or local
government or of the Federal
Government, and one member who is 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.
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17:26 Oct 16, 2019
Jkt 250001
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. 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: October 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22685 Filed 10–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3263]
Request for Nominations of a
Nonvoting Representative of the
Interest of the Tobacco Manufacturing
Industry on the Tobacco Products
Scientific Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting nominations for a nonvoting
representative of the interests of the
tobacco manufacturing industry to serve
on the Tobacco Products Scientific
Advisory Committee (TPSAC), 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. A
nominee may either be self-nominated
or nominated by an organization.
In addition, FDA is requesting that
any industry organizations interested in
participating in the selection of a
nonvoting representative of the interests
of the tobacco manufacturing industry
to serve on the TPSAC notify FDA in
writing. Nominations will be accepted
SUMMARY:
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55575
for either the representative to serve on
TPSAC or for the selection group
effective with this notice.
DATES: Nomination materials for
prospective candidates should be sent to
FDA by November 18, 2019.
Concurrently, any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent the interests of the
tobacco manufacturing industry must
send a letter stating that interest to FDA
by November 18, 2019, (see sections I
and II of this document for further
details).
All nominations for
nonvoting representatives of the
interests of the tobacco manufacturing
industry may be submitted
electronically by accessing the FDA
Advisory Committee Membership
Nomination Portal at: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm, or
by mail to Advisory Committee
Oversight and Management Staff, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002.
All statements of interest from
industry organizations interested in
participating in the selection process of
nonvoting representatives of the
interests of the tobacco manufacturing
industry nomination should be sent to
Janice O’Connor (see FOR FURTHER
INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Janice O’Connor, Office of Science,
Center for Tobacco Products, Food and
Drug Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993–0002, 1–877–287–1373 (choose
Option 5), email: TPSAC@fda.hhs.gov.
Information about becoming a
member of an FDA advisory committee
can also be obtained by visiting FDA’s
website at: https://www.fda.gov/
AdvisoryCommittees/default.htm.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for a nonvoting
representative of the interests of the
tobacco manufacturing industry on the
Tobacco Products Scientific Advisory
Committee (TPSAC).
ADDRESSES:
I. General Description of the Committee
Duties
The TPSAC advises the Commissioner
of Food and Drugs (the Commissioner)
or designee in discharging
responsibilities related to the regulation
of tobacco products. The TPSAC
reviews and evaluates safety,
dependence, or health issues relating to
tobacco products and provides
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17OCN1
55576
Federal Register / Vol. 84, No. 201 / Thursday, October 17, 2019 / Notices
appropriate advice, information, and
recommendations to the Commissioner.
II. Nomination Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
representative of the interests of the
tobacco manufacturing industry.
Nominations must include a current
re´sume´ or curriculum vitae for each
nominee, including current business
address and/or home address, telephone
number, and email address, if available.
Nominations must specify the advisory
committee for which the nominee is
recommended. Nominations must also
acknowledge that the nominee is aware
of the nomination unless selfnominated. The nomination should be
sent to the FDA Advisory Committee
Membership Nomination Portal (see
ADDRESSES) within 30 days of
publication of this document (see
DATES). FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process. (Persons who
nominate themselves as nonvoting
industry representatives will not
participate in the selection process.)
III. Selection Procedure
The Agency is also seeking names of
organizations to participate in the
selection of the nonvoting
representative of the interests of the
tobacco manufacturing industry. Any
industry organization interested in
participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest in participating in
the selection group, attaching a
complete list of all organizations
participating in selection; and a list of
all non-voting nominees along with
their current re´sume´s. The letter will
also state that it is the responsibility of
the interested organizations on the
selection group to confer with one
another and to select a candidate and an
alternative as backup, within 60 days
after the receipt of the FDA letter, to
serve as the nonvoting member to
represent industry interests for the
TPSAC. The interested organizations are
not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
VerDate Sep<11>2014
17:26 Oct 16, 2019
Jkt 250001
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: October 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22683 Filed 10–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0108]
Prescription Drug User Fee Act
Waivers, Reductions, and Refunds for
Drug and Biological Products;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Prescription Drug User Fee Act
Waivers, Reductions, and Refunds for
Drug and Biological Products.’’ This
guidance provides recommendations to
applicants planning to request a waiver
or reduction in user fees. This guidance
finalizes the draft guidance for industry
of the same title issued in June 2018.
DATES: The announcement of the
guidance is published in the Federal
Register on October 17, 2019.
ADDRESSES: You may submit submit
either electronic or written comments
on Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
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comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–D–0108 for ‘‘Prescription Drug
User Fee Act Waivers, Reductions, and
Refunds for Drug and Biological
Products.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
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]]>Agencies
[Federal Register Volume 84, Number 201 (Thursday, October 17, 2019)]
[Notices]
[Pages 55575-55576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22683]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3263]
Request for Nominations of a Nonvoting Representative of the
Interest of the Tobacco Manufacturing Industry on the Tobacco Products
Scientific Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
nominations for a nonvoting representative of the interests of the
tobacco manufacturing industry to serve on the Tobacco Products
Scientific Advisory Committee (TPSAC), 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. A
nominee may either be self-nominated or nominated by an organization.
In addition, FDA is requesting that any industry organizations
interested in participating in the selection of a nonvoting
representative of the interests of the tobacco manufacturing industry
to serve on the TPSAC notify FDA in writing. Nominations will be
accepted for either the representative to serve on TPSAC or for the
selection group effective with this notice.
DATES: Nomination materials for prospective candidates should be sent
to FDA by November 18, 2019. Concurrently, any industry organization
interested in participating in the selection of an appropriate
nonvoting member to represent the interests of the tobacco
manufacturing industry must send a letter stating that interest to FDA
by November 18, 2019, (see sections I and II of this document for
further details).
ADDRESSES: All nominations for nonvoting representatives of the
interests of the tobacco manufacturing industry may be submitted
electronically by accessing the FDA Advisory Committee Membership
Nomination Portal at: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or by mail to Advisory Committee
Oversight and Management Staff, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002.
All statements of interest from industry organizations interested
in participating in the selection process of nonvoting representatives
of the interests of the tobacco manufacturing industry nomination
should be sent to Janice O'Connor (see FOR FURTHER INFORMATION
CONTACT).
FOR FURTHER INFORMATION CONTACT: Janice O'Connor, Office of Science,
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002, 1-877-287-1373 (choose Option 5), email:
[email protected].
Information about becoming a member of an FDA advisory committee
can also be obtained by visiting FDA's website at: https://www.fda.gov/AdvisoryCommittees/default.htm.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a
nonvoting representative of the interests of the tobacco manufacturing
industry on the Tobacco Products Scientific Advisory Committee (TPSAC).
I. General Description of the Committee Duties
The TPSAC advises the Commissioner of Food and Drugs (the
Commissioner) or designee in discharging responsibilities related to
the regulation of tobacco products. The TPSAC reviews and evaluates
safety, dependence, or health issues relating to tobacco products and
provides
[[Page 55576]]
appropriate advice, information, and recommendations to the
Commissioner.
II. Nomination Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting representative of the
interests of the tobacco manufacturing industry. Nominations must
include a current 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. Nominations must
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. The nomination should be sent to the
FDA Advisory Committee Membership Nomination Portal (see ADDRESSES)
within 30 days of publication of this document (see DATES). FDA will
forward all nominations to the organizations expressing interest in
participating in the selection process. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process.)
III. Selection Procedure
The Agency is also seeking names of organizations to participate in
the selection of the nonvoting representative of the interests of the
tobacco manufacturing industry. Any industry organization interested in
participating in the selection of an appropriate nonvoting member to
represent industry interests should send a letter stating that interest
to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days
of publication of this document (see DATES). Within the subsequent 30
days, FDA will send a letter to each organization that has expressed an
interest in participating in the selection group, attaching a complete
list of all organizations participating in selection; and a list of all
non-voting nominees along with their current r[eacute]sum[eacute]s. The
letter will also state that it is the responsibility of the interested
organizations on the selection group to confer with one another and to
select a candidate and an alternative as backup, within 60 days after
the receipt of the FDA letter, to serve as the nonvoting member to
represent industry interests for the TPSAC. The interested
organizations are not bound by the list of nominees in selecting a
candidate. However, if no individual is selected within 60 days, the
Commissioner will select the nonvoting member to represent industry
interests.
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: October 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22683 Filed 10-16-19; 8:45 am]
BILLING CODE 4164-01-P
