
[Federal Register Volume 78, Number 157 (Wednesday, August 14, 2013)]
[Notices]
[Pages 49527-49528]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19683]



[[Page 49527]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

-----------------------------------------------------------------------

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.

DATES: Fax written comments on the collection of information by 
September 13, 2013.

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 emailed to 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: 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: 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 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'').
    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) of the FD&C Act 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 from any manufacturers, importers, or their agents who still 
have documents to submit.
    FDA has been collecting the information submitted under section 
904(a)(4) of the FD&C Act 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 four 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.
    In the Federal Register of April 10, 2013 (78 FR 21379), FDA 
published a 60-day notice requesting public

[[Page 49528]]

comment on the proposed collection of information. FDA received five 
comments; some comments raised more than one issue. Comments relevant 
to the information request are addressed in this document.
    (Comment 1) One comment indicated that the intent of the notice was 
unclear and suggested that FDA revise and republish the notice to 
provide clarity and allow stakeholders more opportunity to comment.
    (Response) FDA published the 60-day information collection notice 
(78 FR 21379) to provide an opportunity for comment on its proposed 
extension of an existing collection of information. The collection 
includes health tobacco documents created during the period June 23, 
2009, through December 31, 2009, that have not been submitted to FDA. 
FDA does not believe that revision of the April 2013 notice would add 
clarity or provide a more meaningful opportunity to comment. FDA has 
met the requirements for the proposed extension of this collection of 
information.
    (Comment 2) Another comment stated that FDA is outside its 
statutory authority in recommending coding/classification and places an 
unnecessary and unreasonable burden on the industry with no benefit to 
FDA in collecting this information.
    (Response) Section 904(a)(4) of the FD&C Act grants FDA the 
authority to collect health document information as specified in this 
document. The classification and coding mentioned in this document are 
recommendations from the April 2010 guidance, and FDA will reevaluate 
and revisit this issue in developing future guidance.
    (Comment 3) Two comments indicated that the timing and burden for 
this collection are underestimated.
    (Response) The estimated burden of 50 hours per response is based 
on the average burden estimate among four 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 
notes that the number of documents received since the original 
collection period has decreased each year and is currently less than 5 
percent of the number received in the year following the Agency's 
original announcement. FDA expects that this collection of information 
will decrease by 7,600 hours because most documents created within the 
specified period have been submitted, and 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.
    (Comment 4) One comment indicated that the information requested in 
this collection is from too narrow a collection window, and another 
comment stated that the collection of 2009 information in 2013 is not 
necessary.
    (Response) Section 904(a)(4) of the FD&C Act sets out an ongoing 
requirement for the submission of tobacco health documents. FDA is in 
the process of revising the April 2010 guidance to specify the timing 
of subsequent submissions. However, the Agency will continue collecting 
documents created during the period from June 23, 2009, through 
December 31, 2009, from any manufacturers, importers, or their agents 
who still have documents to submit.
    (Comment 5) Several comments referred to the 2009 draft guidance 
(74 FR 68629, December 28, 2009) and to previously submitted comments 
on the 2009 draft guidance.
    (Response) The 2009 draft guidance was superseded by publication of 
the April 2010 guidance. FDA considered comments on the 2009 draft 
guidance while developing the April 2010 guidance. Comments on Agency 
guidance are welcome at any time (21 CFR 10.115(g)(5)), and comments 
submitted on the April 2010 guidance will be considered when the 
guidance is revised.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Health Document Submissions and Form FDA 3743..............               4                2                8               50              400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: August 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19683 Filed 8-13-13; 8:45 am]
BILLING CODE 4160-01-P


