[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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