Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability; Extension of Comment Period, 55927 [2011-23098]
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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]
BILLING CODE 4160–01–P
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Draft Guidance for Industry; Dietary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‘‘Draft Guidance for Industry; Dietary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announced the availability of a draft
guidance for industry and requested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request comments on the draft guidance
for industry entitled ‘‘Draft Guidance for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 Comments on the draft
guidance will assist FDA in the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
Sfmt 4703
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
Agencies
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Page 55927]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23098]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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:
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 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