Document ID: FDA-2011-D-0147-0019
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 and Demonstrating the Substantial Equivalence of a New Tobacco
Product: Responses to Frequently Asked Questions
Posted Date: 2015-07-13T04:00Z

[Federal Register Volume 80, Number 133 (Monday, July 13, 2015)]
[Notices]
[Pages 40071-40072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16952]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0147]

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 and 
Demonstrating the Substantial Equivalence of a New Tobacco Product: 
Responses to Frequently Asked Questions

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 and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
12, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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.

Guidance for Industry and Food and Drug Administration 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 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) of the FD&C Act (21 U.S.C. 
387e(j)) authorizes FDA to establish the manner and form for the 
submission of information related to substantial equivalence (SE). In 
guidance documents 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.
    In the Federal Register of March 5, 2015 (80 FR 11989), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment. The commenter 
expressed a concern that small manufacturers have the burden of 
conducting testing without a definitive guide on what will constitute 
substantial equivalence. FDA has carefully considered the burden 
associated with the submission of an SE report. The information needed 
to demonstrate substantial equivalence is dependent on the new product 
and the predicate product that the manufacturer identifies. 
Nevertheless, to assist manufacturers in preparing SE reports, FDA has 
issued guidance documents and participated in outreach such as webinars 
to provide manufacturers with information. Moreover, manufacturers 
seeking to demonstrate substantial equivalence may also contact FDA to 
seek the Agency's input on the specific types of information that the 
Agency believes will be necessary to support the manufacturer's section 
905(j) report. The commenter also supported FDA's development of more 
streamlined SE Reports but challenged ``new requirements on label 
changes,'' and requested that FDA promulgate a rule on categorical 
exclusions (environmental assessments). Although these comments are 
outside of the scope of this PRA collection, FDA intends to consider 
them as part of the Agency's other regulatory efforts as appropriate.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 40072]]

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      No. of
            Activity                  No. of       responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Full SE 905(j)(1)(A)(i) and                   75               1              75             300          22,500
 910(a).........................
Product Quantity Change SE                   125               1             125              87          10,875
 Report.........................
Same Characteristics SE Report..             100               1             100              47           4,700
    Totals......................  ..............  ..............  ..............  ..............          38,075
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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, information related to other 
regulated products, and FDA's expectations regarding the tobacco 
industry's use of the section 905(j) pathway to market their products. 
Table 1 describes the annual reporting burden as a result of the 
implementation of the SE requirements of sections 905(j) and 910(a) of 
the FDC Act (21 U.S.C. 387j(a)). Based on current information, FDA now 
estimates that it will receive 300 section 905(j) reports each year. Of 
these 300 reports, FDA estimates that 75 of these reports will be 
``full'' SE reports that take a manufacturer approximately 300 hours to 
prepare. Under the newly issued guidance entitled, ``Demonstrating the 
Substantial Equivalence of a New Tobacco Product: Responses to 
Frequently Asked Questions,'' FDA is recommending that certain 
modifications might be addressed in either a ``Same Characteristics SE 
Report'' or ``Product Quantity Change Report.'' FDA estimates that it 
will receive 100 Same Characteristics SE Reports and that it will take 
a manufacturer approximately 47 hours to prepare this report. FDA 
estimates that it will receive 125 Product Quantity Change SE Reports 
and that it will take a manufacturer approximately 87 hours to prepare 
this report. Therefore, FDA estimates the burden for submission of SE 
information will be 38,075 hours.

    Dated: July 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16952 Filed 7-10-15; 8:45 am]
 BILLING CODE 4164-01-P