Document ID: FDA-2013-N-0377-0013
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco Health Document Submission
Posted Date: 2022-07-22T04:00Z

[Federal Register Volume 87, Number 140 (Friday, July 22, 2022)]
[Notices]
[Pages 43875-43877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15727]

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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, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Submit written comments (including recommendations) on the 
collection of information by August 22, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0654. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[email protected].

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--Revision

    Section 904(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 387d(a)(4)) 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

[[Page 43876]]

constituents), ingredients, components, and additives'' (herein 
referred to as ``tobacco health documents'' or ``health documents'').
    The guidance document entitled ``Health Document Submission 
Requirements for Tobacco Products (Revised)'' (2017) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-health-document-submission) requests tobacco health document 
submissions from manufacturers and importers of tobacco products based 
on statutory requirements and compliance dates.\1\ As indicated in the 
guidance, 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) of the FD&C Act, 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, so long as a specified set of documents, those 
developed between June 23, 2009, and December 31, 2009, are provided at 
least 90 days prior to the delivery for introduction of tobacco 
products into interstate commerce. Thereafter, manufacturers should 
preserve all health documents, including those that relate to products 
for further manufacturing and those developed after December 31, 2009, 
for future submission to FDA. All Agency guidance documents are issued 
in accordance with our good guidance practice regulations in 21 CFR 
10.115, which provide for public comment at any time.
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    \1\ FDA announced the availability of a guidance on this 
collection in the Federal Register on April 20, 2010 (75 FR 20606) 
(revised December 5, 2016 (81 FR 87565)).
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    FDA is planning revisions to the guidance to reflect that the 
deemed tobacco product compliance period has passed. Additional 
revisions include clarifying and editorial changes to promote a better 
understanding of FDA's interpretation of the ``health, toxicological, 
behavioral, or physiologic'' phrase, examples of health, toxicological, 
behavioral, or physiologic effects documents, and minor updates to the 
metadata list.
    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 
headquarters Dun and Bradstreet D-U-N-S number, and FDA assigned 
Facility Establishment Identifier (FEI) 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.

    You may access the electronic form and paper form on our website, 
at https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal and https://www.fda.gov/media/78652/download, respectively. 
In addition to the electronic and paper forms, FDA issued the guidance 
on this collection 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.
    FDA issued a final rule to deem products meeting the statutory 
definition of ``tobacco product'' to be subject to the FD&C Act on May 
10, 2016 (81 FR 28973), which became effective on August 8, 2016. 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 extended 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, 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.
    In the guidance on this collection, FDA indicated our intent 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 28973 at 29008 and 29009). 
Additionally, FDA extended the compliance deadlines by an additional 6 
months for small-scale manufacturers in the areas impacted by natural 
disasters to May 8, 2018. Thereafter, FDA's compliance plan requested

[[Page 43877]]

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.
    After publication of the 60-day notice however, on March 15, 2022, 
President Biden signed H.R. 2471--the Consolidated Appropriations Act, 
2022. As a result, the FD&C Act now includes specific language that 
makes clear that FDA has the authority to regulate tobacco products 
containing nicotine from any source, which includes synthetic. On April 
14, 2022, firms engaged in the manufacture, preparation, compounding, 
or processing of tobacco products containing non-tobacco nicotine 
products (NTN) must therefore provide health documents.
    In the Federal Register of February 25, 2022 (87 FR 10800), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total  annual    burden per      Total hours
                                    respondents     respondent       responses       response
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Tobacco Health Document                       10             3.2              32              50           1,600
 Submissions and Form FDA 3743..
Tobacco Health Document                      100               1             100               2             200
 Submissions and Form 3743 for
 Non-Tobacco Nicotine Products
 (NTN)..........................
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    Total.......................  ..............  ..............  ..............  ..............           1,800
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    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 as required 
by section 904(a)(4) of the FD&C Act, will take approximately 50 hours 
per submission based on FDA experience. To derive the number of 
respondents for this provision, FDA assumes that very few manufacturers 
or importers, or agents thereof, would have health documents to submit. 
We anticipate documents will be submitted on an annual basis for a 
total of 10 respondents. FDA estimates the annual reporting burden for 
these respondents to be 1,600 hours.
    As mentioned previously in this document, with the new authority 
provided to FDA, firms engaged in the manufacture, preparation, 
compounding, or processing of tobacco products containing NTN must 
provide health documents. Although these firms are unlikely to have 
health documents created within the specified period, we are estimating 
for this extension that we will receive 100 new NTN respondents who 
will be required to provide a declaration to such effect via Form 3743, 
which is expected to take 2 hours, for a total 200 burden hours.
    Based on a review of the information collection of our current OMB 
approval, we have increased the burden by 200 hours.

    Dated: July 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15727 Filed 7-21-22; 8:45 am]
BILLING CODE 4164-01-P