Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability; Extension of Comment Period, 55927 [2011-23098]

Download as PDF 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CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0376] Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability; Extension of Comment Period AGENCY: Food and Drug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and Drug Administration (FDA) is extending the comment period by 60 days to December 2, 2011, for the notice entitled ‘‘Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability,’’ that appeared in the Federal Register of July 5,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 In that document, FDA announced the availability of a draft guidance for industry and requested comments.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: mstockstill on DSK4VPTVN1PROD with NOTICES 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Register of July 5, 2011 (76 FR 39111), FDA published a notice with a 90-day comment period to request comments on the draft guidance for industry entitled ‘‘Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and VerDate Mar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 Comments on the draft guidance will assist FDA in the development of final guidance for industry on new dietary ingredient notifications and related issues.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]


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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.

-----------------------------------------------------------------------

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
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