Document ID: FDA-2011-N-0044-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Guidance for
Industry and Food and Drug Administration Staff; Section 905(j)
Reports: Demonstrating Substantial Equivalence for Tobacco Products
Posted Date: 2011-05-03T04:00Z

[Federal Register Volume 76, Number 85 (Tuesday, May 3, 2011)]
[Notices]
[Pages 24888-24889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10618]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0044]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
and Food and Drug Administration Staff; Section 905(j) Reports: 
Demonstrating Substantial Equivalence for Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review under the Paperwork Reduction 
Act of 1995.

DATES: Fax written comments on the collection of information by June 2, 
2011.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that the written comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk 
Officer. Fax: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB 
control number 0910-0673. Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance: Information Request Regarding Guidance for 
Industry and FDA Staff; Section 905(j) Reports: Demonstrating 
Substantial Equivalence for Tobacco Products--(OMB Control Number 0910-
0673)--Extension.
    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 
111-31) into law. The Tobacco Control Act amended the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) by 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 905(j)(1) of the FD&C Act authorizes FDA to establish the 
form and manner for the submission of information related to 
substantial equivalence (21 U.S.C. 387e(j)(1)). In a level 1 guidance 
document issued under the Good Guidances Practices regulation (21 CFR 
10.115), FDA provides recommendations intended to assist persons 
submitting reports under section 905(j) of the FD&C Act, and explains, 
among other things, FDA's interpretation of the statutory sections 
related to substantial equivalence (see ``Guidance for Industry and FDA 
Staff--Section 905(j) Reports: Demonstrating Substantial Equivalence 
for Tobacco Products'' (January 6, 2011, 76 FR 789).)
    In the Federal Register of January 24, 2011 (76 FR 4116), FDA 
published a 60-day notice requesting public comment on the proposed 
information collection.
    FDA received one comment in response to the 60-day notice. The 
commenter indicated that the substantial equivalence requirements were 
``burdensome to industry in the extreme,'' that FDA's estimation of the 
number of reports to be received was too low, and that the current 
burden hours to complete each report was unrealistic. Although the 
commenter asserted that the burden hours were too low and unrealistic, 
no alternative estimates were provided.
    The recommendations in the ``Guidance for Industry and FDA Staff--
Section 905(j) Reports: Demonstrating Substantial Equivalence for 
Tobacco Products'' are the information that FDA suggests a manufacturer 
include in a report submitted under section 905(j)(1)(A)(i) of the FD&C 
Act. The recommendations reflect the information FDA believes is 
necessary for it to make the required findings under section 910(a) of 
the FD&C Act (21 U.S.C. 387j(a)). FDA has also articulated current 
enforcement policies in its guidances that are intended to address some 
of the burden associated with premarket requirements for new tobacco 
products (manufacturers and interested parties may refer to FDA's

[[Page 24889]]

Web site for guidance documents with current enforcement policies 
related to premarket requirements for tobacco products (http://www.fda.gov/TobaccoProducts/default.htm)).
    With regard to the comment that the number of section 
905(j)(1)(A)(i) substantial equivalence reports which FDA estimated to 
be submitted (150 per year) was too low, FDA has revised its estimate 
based on information it now has from initial submissions, interactions 
with industry, and other information, such as the comment received on 
the 60-day notice on the information collection. As shown below, FDA is 
increasing the annual estimate of the number of reports received from 
150 to 1,000.
    With regard to the comment that the number of hours to prepare and 
submit each report is unrealistic, FDA continues to believe that the 
currently estimated hours (360 hours annually) is appropriate, 
particularly given that the premarket requirements for new tobacco 
products (Section 910 of the FD&C Act) are new and manufacturers' 
experience with preparing a submission is just beginning to develop. As 
the requirements and program become more familiar to respondents, FDA 
may be able to refine these estimates. In addition, as discussed 
previously, the commenter did not suggest an alternative number of 
hours. FDA's estimate of 360 hours reflects an amount of time that 
should provide each submitter enough time to prepare and submit a 
section 905(j)(1)(A)(i) substantial equivalence report to the Agency.

Estimation of Burden

    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
        FD&C Act sections           respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
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905(j)(a)(A)(i) and 910(a)......           1,000               1           1,000             360         360,000
    Total.......................  ..............  ..............  ..............  ..............         360,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA has based these estimates on information it now has available 
from interactions with the industry, comments regarding the submission 
of 905(j)(1)(A)(i) substantial equivalence reports, and comments on the 
60-day information collection notice request for comments published in 
the Federal Register on January 24, 2011 (76 FR 4116). Table 1 of this 
document describes the annual reporting burden as a result of the 
implementation of the substantial equivalence requirements of sections 
905(j)(1)(A)(i) and 910(a) of the FD&C Act. FDA estimates that it will 
receive 1,000 section 905(j) substantial equivalence reports each year 
and that it will take a manufacturer approximately 360 hours to prepare 
a report of substantial equivalence for a new tobacco product. 
Therefore, FDA estimates the burden for submission of substantial 
equivalence information will be 360,000 hours.

    Dated: April 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10618 Filed 5-2-11; 8:45 am]
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