Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice, 70825 [2015-28846]
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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,
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SUMMARY:
VerDate Sep<11>2014
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
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Agencies
[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Page 70825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28846]
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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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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, 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.
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