Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee, 70825-70826 [2015-28847]
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Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices
discontinued product(s), including the
product NDC number(s), and stating that
the manufacturing and/or distribution of
the product(s) have been discontinued.
The letter should be sent electronically
to Barbara Wise (see FOR FURTHER
INFORMATION CONTACT). FDA plans to
rely on its existing records, including its
drug listing records, the results of any
future inspections, or other available
information, when it targets violative
products for enforcement action.
IV. Reformulated Products
FDA cautions firms against
reformulating products into unapproved
new drugs and marketing under the
same name or substantially the same
name (including a new name that
contains the old name). Reformulated
products marketed under a name
previously identified with a different
active ingredient or combinations of
active ingredients have the potential to
confuse health care practitioners and
harm patients.
Dated: November 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Gastroenterology and Urology Devices
Panel of the Medical Devices Advisory
Committee; Amendment of Notice
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is canceling the
November 18, 2015, session and
postponing the November 19, 2015,
session of the Gastroenterology and
Urology Devices Panel meeting. The
meeting was announced in the Federal
Register of October 7, 2015 (80 FR
60686). The November 19, 2015, session
has been postponed due to the
cancellation of the November 18, 2015,
meeting. Future meeting dates will be
announced in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Patricio Garcia, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1535, Silver Spring
MD 20993–0002, patricio.garcia@
fda.hhs.gov, 301–796–6875, or FDA
Advisory Committee Information Line,
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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19:47 Nov 13, 2015
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Dated: November 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–28846 Filed 11–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0394]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Tobacco Products
Scientific Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Tobacco Products Scientific
Advisory Committee, Office of Science,
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 January 15, 2016 will be given
first consideration for membership on
the Tobacco Products Scientific
Advisory Committee. Nominations
received after January 15, 2016 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 Committee Membership
Nomination Portal: 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.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, the primary contact is:
Caryn Cohen, Office of Science,
Center for Tobacco Products, Food and
Drug Administration, Center for
Tobacco Products, Document Control
Center, Building 71, Rm. G335, 10903
SUMMARY:
[FR Doc. 2015–28853 Filed 11–13–15; 8:45 am]
AGENCY:
1–800–741–8138 (301–443–0572 in the
Washington DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
70825
New Hampshire Ave., Silver Spring, MD
20993–0002, 1–877–287–1373 (choose
Option 5), FAX: 240–276–3655,
TPSAC@fda.hhs.gov.
Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
Web site by using the following link:
https://www.fda.gov/
AdvisoryCommittees/default.htm.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members on the Tobacco Products
Scientific Advisory Committee.
I. General Description of the Committee
Duties
The Tobacco Products Scientific
Advisory Committee (the 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, and 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. Members will be invited to
serve for terms of up to 4 years. 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 health care professionals practicing
in the area 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.
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 resume or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available. Nominations must also
E:\FR\FM\16NON1.SGM
16NON1
70826
Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices
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: November 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–28847 Filed 11–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
SUMMARY:
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than December 16,
2015.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
National Health Service Corps Scholar/
Students to Service Travel Worksheet.
OMB No. 0915–0278—Extension.
Abstract: Clinicians participating in
the HRSA National Health Service
Corps (NHSC) Scholarship Program and
the Students to Service (S2S) Loan
Repayment Program use the online
Travel Request Worksheet to receive
travel funds from the federal
government to visit eligible NHSC sites
to which they may be assigned in
accordance with the Public Health
Service Act (PHSA), section 331(c)(1).
The travel approval process is
initiated when an NHSC scholar or S2S
participant notifies the NHSC of an
impending interview at one or more
NHSC-approved practice sites. The
Travel Request Worksheet is also used
to initiate the relocation process after an
NHSC scholar or S2S participant has
successfully been matched to an
approved practice site in accordance
with the PHSA, section 331(c)(3). Upon
receipt of the Travel Request Worksheet,
the NHSC will review and approve or
disapprove the request and promptly
notify the scholar or S2S participant,
and the NHSC logistics contractor
regarding travel arrangements and
authorization of the funding for the site
visit or relocation.
Need and Proposed Use of the
Information: This information will
facilitate NHSC scholar and S2S
clinicians’ receipt of federal travel funds
that are used to visit high-need NHSC
sites. The Travel Request Worksheet is
also used to initiate the relocation
process after an NHSC scholar or S2S
participant has successfully been
matched to an approved practice site.
This information will be used by the
NHSC in order to make travel
arrangements for NHSC scholar and S2S
clinicians to potential practice sites and
to assist them in relocation
arrangements once clinicians have
secured employment at one of these
sites.
Likely Respondents: Clinicians
participating in the National Health
Service Corps Scholarship Program and
the Students to Service Loan Repayment
Program
Statement: Burden in this context
means the time expended by persons to
generate, maintain, retain, disclose or
provide the information requested. This
includes the time needed to review
instructions; to develop, acquire, install
and utilize technology and systems for
the purpose of collecting, validating and
verifying information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN-HOURS
Number of
respondents
Form name
Travel Request Worksheet ..................................................
Total .....................................................................................
Number of
responses per
respondent
250
250
Total
responses
2
2
500
500
tkelley on DSK3SPTVN1PROD with NOTICES
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–29140 Filed 11–13–15; 8:45 am]
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Average
burden per
response
(in hours)
.0667
.0667
Total burden
hours
33
33
Agencies
[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Pages 70825-70826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28847]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0394]
Request for Nominations for Voting Members on a Public Advisory
Committee; Tobacco Products Scientific Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Tobacco Products
Scientific Advisory Committee, Office of Science, 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 January 15, 2016 will be given
first consideration for membership on the Tobacco Products Scientific
Advisory Committee. Nominations received after January 15, 2016 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 Committee Membership Nomination
Portal: 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.
FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions
for membership, the primary contact is:
Caryn Cohen, Office of Science, Center for Tobacco Products, Food
and Drug Administration, Center for Tobacco Products, Document Control
Center, Building 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002, 1-877-287-1373 (choose Option 5), FAX: 240-276-3655,
TPSAC@fda.hhs.gov.
Information about becoming a member on an FDA advisory committee
can also be obtained by visiting FDA's Web site by using the following
link: https://www.fda.gov/AdvisoryCommittees/default.htm.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members on the Tobacco Products Scientific Advisory Committee.
I. General Description of the Committee Duties
The Tobacco Products Scientific Advisory Committee (the 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, and 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. Members will be invited to serve
for terms of up to 4 years. 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 health care professionals practicing in the area 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.
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. Nominations must also
[[Page 70826]]
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: November 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28847 Filed 11-13-15; 8:45 am]
BILLING CODE 4164-01-P