Document ID: FDA-2010-N-0185-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco Health Document Submission
Posted Date: 2010-04-20T04:00Z

[Federal Register: April 20, 2010 (Volume 75, Number 75)]
[Notices]               
[Page 20603-20604]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap10-67]                         

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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: 
Jonnalynn.Capezzuto@fda.hhs.gov.

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