Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Availability, 55927-55928 [2011-23100]
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Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23099 Filed 9–8–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0376]
Draft Guidance for Industry; Dietary
Supplements: New Dietary Ingredient
Notifications and Related Issues;
Availability; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
The Food and Drug
Administration (FDA) is extending the
comment period by 60 days to
December 2, 2011, for the notice entitled
‘‘Draft Guidance for Industry; Dietary
Supplements: New Dietary Ingredient
Notifications and Related Issues;
Availability,’’ that appeared in the
Federal Register of July 5, 2011 (76 FR
39111). In that document, FDA
announced the availability of a draft
guidance for industry and requested
comments. The Agency is taking this
action in response to a request for an
extension to allow interested persons
additional time to submit comments.
DATES: Submit either electronic or
written comments by December 2, 2011.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Corey Hilmas, Center for Food Safety
and Applied Nutrition (HFS–810), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–2375.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
In the Federal Register of July 5, 2011
(76 FR 39111), FDA published a notice
with a 90-day comment period to
request comments on the draft guidance
for industry entitled ‘‘Draft Guidance for
Industry; Dietary Supplements: New
Dietary Ingredient Notifications and
VerDate Mar<15>2010
16:58 Sep 08, 2011
Jkt 223001
Related Issues.’’ Comments on the draft
guidance will assist FDA in the
development of final guidance for
industry on new dietary ingredient
notifications and related issues.
The Agency has received a request for
a 45-day extension of the comment
period for this notice. FDA has
considered the request and is extending
the comment period for the notice
entitled ‘‘Draft Guidance for Industry;
Dietary Supplements: New Dietary
Ingredient Notifications and Related
Issues; Availability,’’ until December 2,
2011. The Agency believes that this
extension allows adequate time for
interested persons to submit comments
without significantly delaying action by
the Agency.
II. 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
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.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Always access an
FDA guidance document by using
FDA’s Web site listed previously to find
the most current version of the
guidance.
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23098 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–D–0147]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Demonstrating the Substantial
Equivalence of a New Tobacco
Product: Responses to Frequently
Asked Questions; Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00061
Fmt 4703
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ACTION:
55927
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Demonstrating the Substantial
Equivalence of a New Tobacco Product:
Responses to Frequently Asked
Questions.’’ This draft guidance
provides responses to questions FDA
has received on the Family Smoking
Prevention and Tobacco Control Act’s
(Tobacco Control Act) provisions on
new tobacco products and substantial
equivalence, including questions on
changes to packaging and labeling. This
draft guidance is not final nor is it in
effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 8,
2011.
ADDRESSES: Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Identify comments with the docket
number found in brackets in the
heading of this document.
Submit written requests for single
copies of the draft guidance document
entitled ‘‘Demonstrating the Substantial
Equivalence of a New Tobacco Product:
Responses to Frequently Asked
Questions’’ to the Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229. Send one
self-addressed adhesive label to assist
that office in processing your request or
include a fax number to which the
guidance document may be sent. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance:
Annette Marthaler, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373,
annette.marthaler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
This draft guidance provides
responses to questions we have received
on the Federal Food, Drug, and
Cosmetic Act’s (the FD&C Act)
provisions on new tobacco products and
E:\FR\FM\09SEN1.SGM
09SEN1
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
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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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]
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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
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[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55927-55928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23100]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0147]
Draft Guidance for Industry and Food and Drug Administration
Staff; Demonstrating the Substantial Equivalence of a New Tobacco
Product: Responses to Frequently Asked Questions; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Demonstrating the
Substantial Equivalence of a New Tobacco Product: Responses to
Frequently Asked Questions.'' This draft guidance provides responses to
questions FDA has received on the Family Smoking Prevention and Tobacco
Control Act's (Tobacco Control Act) provisions on new tobacco products
and substantial equivalence, including questions on changes to
packaging and labeling. This draft guidance is not final nor is it in
effect at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 8, 2011.
ADDRESSES: Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
Submit written requests for single copies of the draft guidance
document entitled ``Demonstrating the Substantial Equivalence of a New
Tobacco Product: Responses to Frequently Asked Questions'' to the
Center for Tobacco Products, Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850-3229. Send one self-addressed
adhesive label to assist that office in processing your request or
include a fax number to which the guidance document may be sent. See
the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance:
Annette Marthaler, Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-
1373, annette.marthaler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance provides responses to questions we have
received on the Federal Food, Drug, and Cosmetic Act's (the FD&C Act)
provisions on new tobacco products and
[[Page 55928]]
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/GuidanceComplianceRegulatoryInformation/default.htm.
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 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