[Federal Register Volume 76, Number 4 (Thursday, January 6, 2011)]
[Notices]
[Pages 789-790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-35]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0635]
Guidance for Industry and Food and Drug Administration Staff;
Section 905(j) Reports: Demonstrating Substantial Equivalence for
Tobacco Products; 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
``Section 905(j) Reports: Demonstrating Substantial Equivalence for
Tobacco Products.'' In general, the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) requires a premarket application and market
authorization order for new tobacco products before they may be
marketed; alternatively, manufacturers may submit a 905(j) report
intended to demonstrate substantial equivalence to a predicate tobacco
product. The guidance provides recommendations on submitting
information intended to demonstrate that a new tobacco product is
substantially equivalent to a predicate tobacco product. Manufacturers
of tobacco products first introduced or delivered for introduction into
interstate commerce for commercial distribution after February 15,
2007, and prior to March 22, 2011, must submit a report no later than
March 22, 2011, or the products can no longer be legally marketed.
Manufacturers of a new tobacco product first introduced or delivered
for introduction into interstate commerce for commercial distribution
after February 15, 2007 and before March 22, 2011, who submit a
substantial equivalence report before March 23, 2011, may continue to
market the tobacco product unless FDA issues an order finding that the
product is not substantially equivalent. Because it is important that
FDA's recommendations on submitting a substantial equivalence reports
be available to assist new tobacco product manufacturers in preparing
substantial equivalence reports in advance of March 23, 2011, this
guidance document will be implemented immediately. This guidance,
however, remains subject to comment in accordance with the Agency's
good guidance practices (GGPs).
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: Submit electronic comments on the guidance, including
comments regarding the proposed collection of information, to http://www.regulations.gov. Submit written comments on the guidance, including
comments regarding the proposed collection of information, 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 guidance document
entitled ``Section 905(j) Reports: Demonstrating Substantial
Equivalence for Tobacco Products'' 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
[[Page 790]]
information on electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Annette Marthaler, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1-877-287-1373, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance that provides
recommendations related to reports under section 905(j) of the FD&C Act
(21 U.S.C. 387e(j)), as amended by the Family Smoking Prevention and
Tobacco Control Act (the Tobacco Control Act) (Pub. L. 111-31). Section
905(j) authorizes FDA to establish the form for the submission of
information related to substantial equivalence. The guidance is
intended to assist persons submitting reports under section 905(j) of
the FD&C Act. It explains, among other things, FDA's interpretation of
the statutory sections related to substantial equivalence, and provides
recommendations on the form and content of section 905(j) reports. The
guidance also provides information on FDA's review of 905(j) reports.
II. Significance of Guidance
FDA is issuing this guidance document as a level 1 guidance
consistent with FDA's GGPs (Sec. 10.115 (21 CFR 10.115)). The guidance
discusses premarket statutory requirements that include certain
submissions to be made to FDA no later than March 22, 2011. This
guidance document is being implemented immediately without prior public
comment under Sec. 10.115(g)(2) because the Agency has determined that
prior public participation is not feasible or appropriate, as
interested parties need clarity as to FDA's expectations regarding
905(j) reports and sufficient time to prepare submissions in advance of
the statutory deadline.
Manufacturers of tobacco products first introduced or delivered for
introduction into interstate commerce for commercial distribution after
February 15, 2007, and prior to March 22, 2011, must submit the report
no later than March 22, 2011, or the tobacco product can no longer be
legally marketed. If a 905(j) report is submitted prior to March 23,
2011, the tobacco product may continue to be marketed unless FDA issues
an order that the tobacco product is not substantially equivalent to
the predicate tobacco product (section 910(a)(2)(B) of the FD&C Act (21
U.S.C. 387j(a)(2)(B)), as amended by the Tobacco Control Act). It is
important that this guidance be available in advance of March 23, 2011,
to assist manufacturers in preparing 905(j) reports.
For 905(j) reports for tobacco products first marketed between
February 15, 2007, and March 22, 2011 (many of which are from small
manufacturers) that are submitted prior to March 23, 2011, FDA intends
to allow manufacturers who have acted diligently in preparing their
submissions a reasonable amount of time to supplement their initial
submissions, provided these manufacturers submit a 905(j) report by the
statutory deadline. FDA intends to determine what constitutes a
reasonable period of time on a case-by-case basis.
This guidance 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 contains information collection provisions that 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
collection of information in this guidance was approved under OMB
control number 0910-0673.
IV. Comments
This guidance document is being implemented immediately without
prior public comment under Sec. 10.115(g)(2) because the Agency has
determined that prior public participation is not feasible or
appropriate, as interested parties need clarity as to FDA's
expectations regarding 905(j) reports and sufficient time to prepare
submissions in advance of the statutory deadline. You may submit
written comments to FDA on this guidance at any time for Agency
consideration; in addition, we request that you submit any comments
regarding any significant oversight in this guidance within 30 days of
the issuance of this guidance (refer to the title page of the guidance
for the issue date). 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. FDA will review any comments we receive and revise the
guidance document when appropriate.
V. Electronic Access
An electronic version of the guidance document is available on the
Internet at http://www.regulations.gov and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-35 Filed 1-5-11; 8:45 am]
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