[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Notices]
[Pages 22860-22862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10402]


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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.

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[[Page 22861]]

SUMMARY: The Food and Drug Administration (FDA or Agency) 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 June 
19, 2019.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@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 (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. Additionally, 
section 101 of the Tobacco Control Act amended the FD&C Act by adding, 
among other things, new 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 4, 2010, (75 FR 20606) (revised December 
5, 2016, (81 FR 87565) and August 10, 2017, (82 FR 37459) (extending 
compliance dates)) and requested health documents that were created 
during the period of June 23, 2009, through December 31, 2009, based on 
the statutory requirements. 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. However, FDA also explained that it 
did not intend to enforce the December 22, 2009, deadline provided that 
the documents were submitted by April 30, 2010, for all health 
documents developed between June 23, 2009, and December 31, 2009. 
Further, FDA stated it would publish a revised guidance specifying the 
timing of subsequent reporting.
    FDA has been collecting the information submitted pursuant to 
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. On 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 
headquarter's Dun and Bradstreet D-U-N-S number, and FDA assigned 
Facility Establishment Identifier number
 Submitter point of contact
 Contact name, title, position title, email, telephone, and fax
 Submission format and contents (as applicable)
 Electronic documents: Media type, media quantity, size of 
submission, quantity of documents, file type, and file software
 Paper documents: Quantity of documents, quantity of volumes, 
and quantity of boxes
 Whether or not a submission is being provided
 Confirmation statement
 Identification and signature of submitter including name, 
company name, address, position title, email, telephone, and Fax
 Document categorization (as applicable): relationship of the 
document or set of documents to the following:
    [cir] Health, behavioral, toxicological, or physiological effects
    [cir] Uniquely identified current or future tobacco product(s)
    [cir] Category 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.
 Document metadata: Date document was created, document 
author(s), document recipient(s), document custodian, document title or 
identification number, beginning and ending Bates numbers, Bates number 
ranges for documents attached to a submitted email, document type, and 
whether the document is present in the University of California San 
Francisco's Truth Tobacco Documents database.

    In addition to the electronic and paper forms, FDA issued guidance 
documents intended to assist persons making tobacco health document 
submissions (draft guidance: December 28, 2009 (74 FR 68629); final 
guidance: April 20, 2010 (75 FR 20606); revised December 5, 2016 (81 FR 
87565); and August 10, 2017 (82 FR 37459) (extending compliance 
dates)). For further assistance, FDA is providing a technical guide, 
embedded hints, and a web tutorial on the electronic portal.
    FDA issued a final rule on May 10, 2016 (81 FR 28973), which became 
effective on August 8, 2016, to deem products meeting the statutory 
definition of ``tobacco product'' to be subject to the FD&C Act. The 
FD&C Act provides FDA authority to regulate cigarettes, cigarette 
tobacco, roll-your-own tobacco (RYO), smokeless tobacco, and any other 
tobacco products that the Agency by regulation deems to be subject to 
the law. This final rule extends the Agency's ``tobacco product'' 
authorities to all other categories of products that meet the statutory 
definition of ``tobacco product'' in the FD&C Act, except accessories 
of such deemed tobacco products.
    For tobacco products subject to the deeming rule, FDA understands 
``current or future tobacco products'' to refer to products 
commercially distributed on or after August 8, 2016, or products in any 
stage of research or development at any time after August 8,

[[Page 22862]]

2016, including experimental products and developmental products 
intended for introduction into the market for consumer use. For 
cigarettes, cigarette tobacco, RYO, and smokeless tobacco, FDA 
understands ``current or future tobacco products'' to refer to products 
commercially distributed on or after June 23, 2009, or products in any 
stage of research or development at any time after June 23, 2009, 
including experimental products and developmental products intended for 
introduction into the market for consumer use.
    All manufacturers and importers of tobacco products are now subject 
to the FD&C Act and are required to comply with section 904(a)(4), 
which requires immediate and ongoing submission of health documents 
developed after June 22, 2009 (the date of enactment of the Tobacco 
Control Act). However, FDA generally does not intend to enforce the 
requirement at this time with respect to all such health documents 
relating to the deemed tobacco products, so long as a specified set of 
documents, those developed between June 23, 2009, and December 31, 
2009, were submitted by February 8, 2017, or in the case of small-scale 
deemed tobacco product manufacturers (small-scale manufacturers), by 
November 8, 2017 (81 FR 28974 at 29008-09). Additionally, FDA extended 
the compliance deadlines by an additional 6 months to May 8, 2018, for 
small-scale manufacturers in the areas impacted by recent natural 
disasters. Thereafter, FDA's compliance plan requests deemed 
manufacturers provide tobacco health document submissions from the 
specified period at least 90 days prior to the delivery for 
introduction into interstate commerce of tobacco products to which the 
health documents relate. Manufacturers or importers of cigarettes, 
cigarette tobacco, RYO, or smokeless tobacco products must provide all 
health documents developed between June 23, 2009, and December 31, 
2009, at least 90 days prior to the delivery for introduction of 
tobacco products into interstate commerce.
    In the Federal Register of August 23, 2018 (83 FR 42664), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received that was PRA 
related.
    (Comment) FDA received one comment requesting that FDA exercise 
enforcement discretion by suspending the collection and utilizing the 
Agency's other authorities to inform regulatory decisions due to the 
associated burden of manufacturers to retain documents for future 
submission to FDA. Additionally, the commenter requests FDA to narrow 
the scope of the collection by defining key terms.
    (Response) At this time, FDA does not intend to suspend the 
collection as respondents have the option to submit documents directly 
to FDA independent of the compliance policy. Additionally, at this 
time, FDA believes narrowly defining health effects could potentially 
exclude relevant scientific information from being retained by industry 
and subsequently submitted as part of future health document 
submissions.
    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 Submissions and Form FDA 3743..............              10              3.2               32               50            1,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of documents received each year since the original 
collection period has fallen to less than 5 percent of what was 
received in the original collection period. FDA expects this is because 
documents created within the specified period should have already been 
submitted. The Agency bases this estimate on the total number of 
tobacco firms it is aware of and its experience with document 
production and the number of additional documents that have been 
reported each year since the original estimate of the reporting burden.
    FDA estimates that a tobacco health document submission for cigars, 
pipe and waterpipe tobacco, electronic nicotine delivery systems 
(ENDS), and other tobacco products as required by section 904(a)(4) of 
the FD&C Act, will take approximately 50 hours per submission based on 
the existing collection that applies to tobacco products currently 
subject to the FD&C Act and FDA experience. To derive the number of 
respondents for this provision, FDA assumes that very few manufacturers 
or importers of deemed tobacco products, or agents thereof, would have 
health documents to submit. In addition to the existing 4 respondents, 
the Agency estimates that approximately 6 submissions (2 for cigar 
manufacturers, 1 for pipe and waterpipe tobacco manufacturers, 1 for 
other tobacco product manufacturers, 1 for tobacco importers, and 1 for 
importers of ENDS that are considered manufacturers) will be submitted 
on an annual basis for a total of 10 respondents. FDA estimates the 
total annual reporting burden to be 1,600 hours.
    Based on a review of the information collection of our current OMB 
approval, we have made no adjustments to our burden estimate.

    Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10402 Filed 5-17-19; 8:45 am]
 BILLING CODE 4164-01-P


