Document ID: FDA-2013-N-0377-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission
Posted Date: 2013-04-10T04:00Z

[Federal Register Volume 78, Number 69 (Wednesday, April 10, 2013)]
[Notices]
[Pages 21379-21380]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08315]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0377]

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 collection of health 
documents that were created during the period of June 23, 2009, through 
December 31, 2009.

DATES: Submit either electronic or written comments on the collection 
of information by June 10, 2013.

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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
daniel.gittleson@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.
    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.

Tobacco Health Document Submission--(OMB Control Number 0910-0654)--
Extension

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (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, among other things, a new 
chapter granting FDA important authority to regulate the manufacture, 
marketing, and distribution of tobacco products to protect the public 
health generally and to reduce tobacco use by minors. The Tobacco 
Control Act created many new requirements for the tobacco industry. 
Section 101 of the Tobacco Control Act amended the FD&C Act by adding, 
among other things, section 904(a)(4) (21 U.S.C. 387d(a)(4)).
    Section 904(a)(4) of the FD&C 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'' (herein referred to as 
``tobacco health documents'').

[[Page 21380]]

    FDA announced the availability of a guidance on this collection in 
the Federal Register of April 20, 2010 (75 FR 20606), and requested 
tobacco health documents that were created during the period from June 
23, 2009, through December 31, 2009. The guidance stated that 
information required under section 904(a)(4) must be submitted to FDA 
beginning December 22, 2009. Further, FDA stated it would publish a 
revised guidance specifying the timing of subsequent reporting. FDA is 
in the process of revising the April 2010 guidance but will continue 
collecting documents created during the specified period for any 
manufacturers, importers, or their agents who still have documents to 
submit.
    FDA has been collecting the information submitted pursuant to 
section 904(a)(4) through a facilitative electronic form and through a 
paper form (Form FDA 3743) for those individuals who choose not to use 
the electronic method. In both forms, FDA is requesting the following 
information from firms that have not already reported or still have 
documents to report:
     Submitter identification: Submitter type, company name, 
address, country, company headquarters Dun and Bradstreet number, and 
company headquarters Facility Establishment Identifier number;
     Submitter point of contact: Contact name, title, position 
title, email, telephone, and fax; and
     Submission format and contents (as applicable):
    [cir] Electronic documents: Media type, media quantity, size of 
submission, quantity of documents, file type, and file software;
    [cir] Paper documents: Quantity of documents, quantity of volumes, 
and quantity of boxes; and
    [cir] Whether or not a submission is being provided.
     Confirmation statement (with identification and signature 
of submitter including name, company name, address, position title, 
email, telephone, and fax); and
     Document categorization (as applicable): Relationship of 
the document or set of documents to the following:
    [cir] Health, behavioral, toxicological, or physiological effects;
    [cir] Specific current or future tobacco product(s);
    [cir] Class of current or future tobacco product(s);
    [cir] Specific ingredient(s), constituent(s), component(s), or 
additive(s);
    [cir] Class of ingredient(s), constituent(s), component(s), or 
additive(s).
     Document readability and accessibility: Keywords; glossary 
or explanation of any abbreviations, jargon, or internal (e.g., code) 
names; special instructions for loading or compiling submission; and
     Document metadata: Date document was created, document 
author(s), document recipient(s), document custodian, document title or 
identification number, beginning and ending Bates numbers, and Bates 
number ranges for documents attached to a submitted email.
    In addition to the electronic and paper forms, the guidance that 
FDA issued in April 2010 (75 FR 20606) was intended to assist persons 
making tobacco health document submissions. For further assistance, FDA 
is providing a technical guide, embedded hints, and a Web tutorial on 
the electronic portal.
    The estimated 50 hours per response burden is based on the average 
burden estimate among all 4 respondents. Therefore, on an individual 
basis, the actual burden per respondent may be higher or lower than the 
50 hours estimate because it is an average value. FDA currently is 
evaluating the classification/coding recommendations and will revisit 
this issue in future guidance. The number of documents received each 
year since the original collection period has fallen to less than 5 
percent of the number received in the original collection period. FDA 
expects this is because documents created within the specified period 
have already been submitted. Also, the number of respondents who still 
have documents to submit has decreased. Therefore, FDA estimates the 
biannual burden of the continuation of this collection to be at most, 5 
percent of the original burden.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Tobacco Health Document                        4               2               8              50             400
 Submissions 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: April 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08315 Filed 4-9-13; 8:45 am]
BILLING CODE 4160-01-P