Document ID: FDA-2013-N-0377-0012
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Tobacco Health Document Submission
Posted Date: 2022-02-25T05:00Z

[Federal Register Volume 87, Number 38 (Friday, February 25, 2022)]
[Notices]
[Pages 10800-10803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03994]

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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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 information collection associated with 
the tobacco health document submission.

DATES: Submit either electronic or written comments on the collection 
of information by April 26, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 26, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 26, 2022. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are

[[Page 10801]]

solely responsible for ensuring that your comment does not include any 
confidential information that you or a third party may not wish to be 
posted, such as medical information, your or anyone else's Social 
Security number, or confidential business information, such as a 
manufacturing process. Please note that if you include your name, 
contact information, or other information that identifies you in the 
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0377 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Tobacco Health Document 
Submission.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), 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 Family Smoking Prevention and Tobacco Control 
Act (Tobacco Control Act) (Pub. L. 111-31) was enacted. 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'').
    The guidance document ``Health Document Submission Requirements for 
Tobacco Products (Revised)'' (2017) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-health-document-submission) requests health documents 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), 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

[[Page 10802]]

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 
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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 10803]]

                                                     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 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 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: February 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03994 Filed 2-24-22; 8:45 am]
BILLING CODE 4164-01-P