[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Page 12011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05023]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0147]
Demonstrating the Substantial Equivalence of a New Tobacco
Product: Responses to Frequently Asked Questions; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance for industry entitled ``Demonstrating the
Substantial Equivalence of a New Tobacco Product: Responses to
Frequently Asked Questions.'' This guidance provides information in
response to questions that FDA has received from manufacturers on
demonstrating the substantial equivalence of a new tobacco product,
including questions on when a modification to the label requires a
premarket submission and review by FDA.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the 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, Document
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002. 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.
Submit electronic comments on the guidance to http://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.
FOR FURTHER INFORMATION CONTACT: Annette Marthaler, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, Bldg.
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002;
1-877-287-1373, [email protected], email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Demonstrating the Substantial Equivalence of a New Tobacco
Product: Responses to Frequently Asked Questions.'' In this guidance,
FDA addresses questions from manufacturers on demonstrating the
substantial equivalence of a new tobacco product. In the Federal
Register of September 9, 2011 (76 FR 55927), FDA announced the
availability of the draft guidance of the same title. After carefully
reviewing and considering comments and information submitted in
response to the draft guidance, which covered a range of topics on
demonstrating the substantial equivalence of a new tobacco product, FDA
is finalizing this guidance on many of the topics, including
modifications to labels and changes to product quantity and intends to
address the other topics in future regulatory documents.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on this topic. 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. Paperwork Reduction Act of 1995
This guidance refers to previously approved information collections
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 (21 U.S.C.
387e(j) and 387j), 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.
IV. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at http://www.regulations.gov.
V. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: February 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05023 Filed 3-4-15; 8:45 am]
BILLING CODE 4164-01-P