[Federal Register Volume 76, Number 20 (Monday, January 31, 2011)]
[Notices]
[Pages 5387-5388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1990]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0281]
Guidance for Industry and Food and Drug Administration Staff;
```Harmful and Potentially Harmful Constituents' in Tobacco Products as
Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act'';
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 a guidance for industry and FDA staff entitled
```Harmful and Potentially Harmful Constituents' in Tobacco Products as
Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.''
This guidance provides written guidance to industry and FDA staff on
certain provisions of the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act).
DATES: Submit either electronic or written comments on this guidance at
any time.
ADDRESSES: Submit written requests for single copies of this guidance
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 requests or
include a fax number to which the guidance document may be sent. See
the SUPPLEMENTARY INFORMATION section for 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.
[[Page 5388]]
FOR FURTHER INFORMATION CONTACT: Carol Drew, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229, 301-796-3505.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 10, 2010 (75 FR 32952), FDA
announced the availability of a draft guidance entitled ```Harmful and
Potentially Harmful Constituents' in Tobacco Products as Used in
Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' The
Agency considered received comments as it finalized this guidance. The
guidance document discusses the meaning of the term ``harmful and
potentially harmful constituent'' in the context of implementing the
listing requirements of section 904(e) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 387d(e)).
On June 22, 2009, the President signed the Tobacco Control Act
(Pub. L. 111-310) into law. The Tobacco Control Act amended the FD&C
Act by, among other things, adding a new chapter granting FDA important
new authority to regulate the manufacture, marketing, and distribution
of tobacco products to protect the public health generally and to
reduce tobacco use by minors. Section 904(e) of the FD&C Act, as added
by the Tobacco Control Act, requires FDA to establish, and periodically
revise as appropriate, ``a list of harmful and potentially harmful
constituents, including smoke constituents, to health in each tobacco
product by brand and by quantity in each brand and subbrand.'' The
guidance discusses the meaning of the term ``harmful and potentially
harmful constituent'' in the context of implementing the listing
requirements of section 904(e).
II. Significance of Guidance
This guidance is being issued as a level 1 guidance consistent with
FDA's good guidance practices regulation (21 CFR 10.115). The guidance
represents the Agency's current thinking on the meaning of the term
``harmful and potentially harmful constituents'' in the context of
section 904(e) of the FD&C Act. 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 statutes and regulations.
III. 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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http:[sol][sol]www.regulations.gov or
http:[sol][sol]www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatoryInformation/default.htm.
Dated: January 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1990 Filed 1-28-11; 8:45 am]
BILLING CODE 4160-01-P