Food and Drug Administration Health Professional Organizations Conference, 55928 [2011-23101]
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55928
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
substantial equivalence (sections 905(j)
and 910 of the FD&C Act, as amended
by the Tobacco Control Act (21 U.S.C.
387e(j) and 387j)). In this draft guidance,
FDA provides responses to questions
related to the submission of 905(j)
(substantial equivalence) reports in
specific scenarios, including questions
on whether changes to packaging and
labeling and changes to additive
specifications should be submitted in a
905(j) report to the Center for Tobacco
Products. The draft guidance also
provides information about discussing
submissions.
II. Significance of Guidance
This draft guidance is being issued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The draft guidance, when finalized, will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 Agency’s current thinking
on ‘‘Demonstrating the Substantial
Equivalence of a New Tobacco Product:
Responses to Frequently Asked
Questions.’’ It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
An electronic version of the draft
guidance document is available on the
Internet at https://www.regulations.gov
and https://www.fda.gov/
TobaccoProducts/GuidanceCompliance
RegulatoryInformation/default.htm.
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IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in sections 905(j) and 910
of the FD&C Act, as amended by the
Tobacco Control Act have been
approved under OMB control number
0910–0673; the collections of
information in 21 CFR part 25 have been
approved under OMB control number
0910–0322.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
VerDate Mar<15>2010
16:58 Sep 08, 2011
Jkt 223001
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23100 Filed 9–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Food and Drug Administration Health
Professional Organizations
Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug Administration
(FDA) is announcing a conference for
representatives of Health Professional
Organizations. Dr. Margaret Hamburg,
Commissioner of the Food and Drugs,
and Dr. Janet Woodcock, Director of
FDA’s Center for Drug Evaluation and
Research have been invited to speak
about their visions of the relationship
between the Agency and the health
professional community. Other topics
on the agenda include Risk Evaluation
and Mitigation Strategies and the
Unapproved Drugs Initiative.
Date and Time: The conference will
be held on October 31, 2011, from 8 a.m.
to 1:30 p.m.
Location: The conference will be held
at the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Contact Person: For further
information contact Janelle Derbis,
Office of Special Health Issues, 10903
New Hampshire Ave., Silver Spring, MD
20993, 312–596–6516, Fax: 312–886–
1682, Janelle.Derbis@fda.hhs.gov.
Registration: Register at https://
www.cvent.com/d/fcq7vv/4W by
October 7, 2011. Please include the
name and title of the person attending,
the name of the organization, address,
and telephone number. There is no
registration fee for this conference. Early
registration is suggested because space
is limited. We request that organizations
limit the number of representatives to
two. For further registration
information, call 1–866–318–4357.
SUPPLEMENTARY INFORMATION: The aim of
the conference is to further the public
health mission of the FDA through
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Fmt 4703
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training, collaboration, and structured
discussion between health professional
organizations and FDA staff. The Office
of Special Health Issues serves as a
liaison between the FDA Centers and
the public on matters that involve
medical product safety and also acts as
the public’s link to information about
the medical product approval process.
The topics of discussion for this
conference will include three separate
panels that will highlight examples
where FDA and health professional
organizations collaborate to further
public health. The goal of the panel
presentations is to exchange ideas,
highlight the value of FDA and health
professional organizations working
together, and encourage collaboration to
promote public health. A list of
concurrent breakout session topics is
included in the agenda to facilitate
informal discussion on how FDA and
health professional organizations can
collaborate more effectively. Please
indicate during your registration the
topics of greatest interest to you for the
breakout session.
If you need special accommodations
due to a disability, please contact
Janelle Derbis at least 7 days in advance.
Dated: September 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23101 Filed 9–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health
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
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Conflicts and Eating Disorders.
Date: October 4, 2011.
Time: 3 p.m. to 5 p.m.
E:\FR\FM\09SEN1.SGM
09SEN1
]]>Agencies
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Page 55928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Food and Drug Administration Health Professional Organizations
Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a conference
for representatives of Health Professional Organizations. Dr. Margaret
Hamburg, Commissioner of the Food and Drugs, and Dr. Janet Woodcock,
Director of FDA's Center for Drug Evaluation and Research have been
invited to speak about their visions of the relationship between the
Agency and the health professional community. Other topics on the
agenda include Risk Evaluation and Mitigation Strategies and the
Unapproved Drugs Initiative.
Date and Time: The conference will be held on October 31, 2011,
from 8 a.m. to 1:30 p.m.
Location: The conference will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993-0002.
Contact Person: For further information contact Janelle Derbis,
Office of Special Health Issues, 10903 New Hampshire Ave., Silver
Spring, MD 20993, 312-596-6516, Fax: 312-886-1682,
Janelle.Derbis@fda.hhs.gov.
Registration: Register at https://www.cvent.com/d/fcq7vv/4W by
October 7, 2011. Please include the name and title of the person
attending, the name of the organization, address, and telephone number.
There is no registration fee for this conference. Early registration is
suggested because space is limited. We request that organizations limit
the number of representatives to two. For further registration
information, call 1-866-318-4357.
SUPPLEMENTARY INFORMATION: The aim of the conference is to further the
public health mission of the FDA through training, collaboration, and
structured discussion between health professional organizations and FDA
staff. The Office of Special Health Issues serves as a liaison between
the FDA Centers and the public on matters that involve medical product
safety and also acts as the public's link to information about the
medical product approval process.
The topics of discussion for this conference will include three
separate panels that will highlight examples where FDA and health
professional organizations collaborate to further public health. The
goal of the panel presentations is to exchange ideas, highlight the
value of FDA and health professional organizations working together,
and encourage collaboration to promote public health. A list of
concurrent breakout session topics is included in the agenda to
facilitate informal discussion on how FDA and health professional
organizations can collaborate more effectively. Please indicate during
your registration the topics of greatest interest to you for the
breakout session.
If you need special accommodations due to a disability, please
contact Janelle Derbis at least 7 days in advance.
Dated: September 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23101 Filed 9-8-11; 8:45 am]
BILLING CODE 4160-01-P
