[Federal Register Volume 75, Number 75 (Tuesday, April 20, 2010)]
[Notices]
[Pages 20603-20604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8976]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0185]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Tobacco Health Document Submission
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 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 proposed extension of an
existing collection of information pertaining to the submission of
tobacco health documents under the Family Smoking Prevention and
Tobacco Control Act (the Tobacco Control Act).
DATES: Submit written or electronic comments on the collection of
information by June 21, 2010.
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: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50
Rockville, MD 20850, 301-796-3794, Email:
[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.
[[Page 20604]]
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.
Title: Tobacco Health Document Submission (OMB Control Number 0910-
0654)--Extension
On June 22, 2009, the President signed the Tobacco Control Act
(Public Law 111-31) into law. The Tobacco Control Act granted 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. Among its many provisions, the
Tobacco Control Act added section 904(a)(4) to the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 387d(a)(4)), requiring submission
of documents related to certain effects of tobacco products.
Section 904(a)(4) of the act requires each tobacco product
manufacturer or importer, or agent thereof, to submit all documents
developed after June 22, 2009 ``that relate to health, toxicological,
behavioral, or physiologic effects of current or future tobacco
products, their constituents (including smoke constituents),
ingredients, components, and additives.'' Information required under
section 904(a)(4) of the act must be submitted to FDA beginning
December 22, 2009.
FDA issued a draft guidance document entitled, ``Tobacco Health
Document Submission'' on December 28, 2009 (74 FR 68629) to assist
persons making certain document submissions to FDA under section
904(a)(4) of the act. While electronic submission of tobacco health
documents is not required, FDA designed the eSubmitter application as
an alternative for mailing documents. This electronic tool allows for
importation of large quantities of structured data, attachments of
files (e.g., in portable document format (PDFs) and certain media
files), and automatic acknowledgement of FDA's receipt of submissions.
FDA also is developing a paper form (FDA Form 3743) as an alternative
submission tool. Both the eSubmitter application and the paper form can
be accessed at http://www.fda.gov/tobacco once they are complete.
On September 1, 2009 (74 FR 45219), FDA published notice in the
Federal Register announcing that a proposed collection of information
had been submitted to OMB for emergency processing under the Paperwork
Reduction Act of 1995. On September 15, 2009 (74 FR 47257), FDA
published a notice correcting the length of the comment period, keeping
it open until October 1, 2009. On October 13, 2009 (74 FR 52495), FDA
published a notice reopening the comment period until October 26, 2009.
On January 7, 2010, FDA received emergency approval for this
information collection. Based on comments indicating that the burden
estimate was too low, FDA has adjusted its original burden estimate
from 1.0 hour per response to 200 hours per response. FDA also
increased the annual frequency per response from 1 to 4 (quarterly).
FDA is maintaining the original estimate of the number of respondents
at 10. FDA is basing its estimates on the total number of tobacco firms
it is aware of, its experience with document production, and comments
received in response to the draft guidance document published on
December 28, 2009.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual Hours per
Activity No. of Respondents per Response Responses Response Total Hours
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Tobacco 10 4 40 200 8,000
Health
Document
Submission
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 14, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8976 Filed 4-19-10; 8:45 am]
BILLING CODE 4160-01-S