[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Notices]
[Pages 78974-78975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30880]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1558]
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 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 request
regarding the guidance for industry and FDA staff entitled ``Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products.''
DATES: Submit either electronic or written comments on the collection
of information by February 25, 2014.
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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, [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
[[Page 78975]]
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.
Information Request Regarding Guidance for Industry and FDA 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 (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. 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FD&C act sections Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
905(j)(1)(A)(i) and 910(a)......................................... 1,000 1 1,000 360 360,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 substantial equivalence requirements of sections
905(j) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)). FDA estimates
that it will receive 1,000 section 905(j) 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: December 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30880 Filed 12-26-13; 8:45 am]
BILLING CODE 4160-01-P