Document ID: FDA-2010-N-0185-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco Health Document Submission
Posted Date: 2010-07-15T04:00Z

[Federal Register: July 15, 2010 (Volume 75, Number 135)]
[Notices]               
[Page 41210-41211]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jy10-59]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0185]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 (the PRA).

DATES: Fax written comments on the collection of information by August 
16, 2010.

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 e-mailed to

[[Page 41211]]

oira_submission@omb.eop.gov. All comments should be identified with 
the OMB control number 0910-0654. Also include the FDA 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., PI50-400B, 
Rockville, MD 20850, 301-796-3794, Jonnalynn.Capezzuto@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.

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. The guidance document was finalized on April 20, 
2010 (75 FR 20606). 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 developed 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.
    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 PRA. 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.
    In the Federal Register of April 20, 2010 (75 FR 20603), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment in response to the 
60-day notice soliciting public comment on the extension of OMB 
approval for this information collection. The comment stated that the 
classification/coding recommendations will impose burdens that 
significantly exceed the burden estimate of 200 hours and will likely 
inundate FDA with information with little incremental value. The 
estimated 200 hours per response burden is based on the average burden 
estimate among all 10 respondents. Therefore, on an individual basis, 
the actual burden per respondent may be higher or lower than the 200 
hours estimate since it is an average value. FDA currently is 
evaluating the classification/coding recommendations and will revisit 
this issue in future guidance.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                  No. of          Annual Frequency       Total Annual          Hours per
 Activity       Respondents         per Response           Responses           Response          Total  Hours
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Tobacco                     10                     4                  40             200                   8,000
 Health
 Document
 Submissio
 n and
 Form FDA
 3743
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: July 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17230 Filed 7-14-10; 8:45 am]
BILLING CODE 4160-01-S