[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 11989-11990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05024]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0147]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed
[[Page 11990]]
extension of an existing collection of information, and to allow 60
days for public comment in response to the notice. This notice solicits
comments on the information collections in the guidances for industry
and FDA staff entitled ``Guidance for Industry and Food and Drug
Administration Staff on 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.''
DATES: Submit either electronic or written comments on the collection
of information by May 4, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance for Industry and Food and Drug Administration Staff on 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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average
Activity Number of responses per annual burden per Total hours
respondents respondent responses response
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Full SE 905(j)(1)(A)(i) and 910(a).......... 75 1 75 300 22,500
Product Quantity Change SE Report........... 125 1 125 87 10,875
Same characteristics SE Report.............. 100 1 100 47 4,700
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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: February 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05024 Filed 3-4-15; 8:45 am]
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