[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25280-25282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09072]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0305]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Tobacco Products Subject to the Federal Food, Drug, 
and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, we, 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 ``Tobacco Products Subject to 
the Federal Food, Drug, and Cosmetic Act.''

DATES: Submit either electronic or written comments on the collection 
of information by June 27, 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 June 27, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 27, 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 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-2019-N-0305 for ``Tobacco Products Subject to the Federal Food, 
Drug, and Cosmetic Act.'' 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: Jonnalynn Capezzuto, Office of 
Operations, Food and Drug

[[Page 25281]]

Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., 
North Bethesda, MD 20852, 301-796-3794, [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 Products Subject to the Federal Food, Drug, and Cosmetic Act

OMB Control Number 0910-0768--Extension

    Tobacco products are governed by chapter IX of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (sections 900 through 920) (21 U.S.C. 
387 through 21 U.S.C. 387t). Implementing regulations are found in 21 
CFR subchapter K (21 CFR parts 1100 through 1150). This information 
collection supports the reporting, recordkeeping, and third-party 
disclosure requirements associated with statutory requirements 
applicable to tobacco products and set forth in Agency regulations. 
Section 910(a)(1) of the FD&C Act (21 U.S.C. 387j(a)(1)) defines a 
``new tobacco product'' as a tobacco product that was not commercially 
marketed in the United States on February 15, 2007, or a modification 
(including a change in design, any component, any part, or any 
constituent, including a smoke constituent, or in the content, 
delivery, or form of nicotine, or any other additive or ingredient) of 
a tobacco product where the modified product was commercially marketed 
in the United States after February 15, 2007. An order under section 
910(c)(1)(A)(i) of the FD&C Act is required prior to marketing a new 
tobacco product. This requirement applies unless the product has been 
shown to be substantially equivalent to a valid predicate product or is 
exempt from substantial equivalence (21 CFR 1107.1).
    Section 910(b) of the FD&C Act states that a premarket tobacco 
application (PMTA) (21 CFR part 1114) shall contain full reports of all 
investigations of health risks; a full statement of all components, 
ingredients, additives, and properties, and of the principle or 
principles of operation of such tobacco product; a full description of 
methods of manufacturing and processing (which includes: a listing of 
all manufacturing, packaging, and control sites for the product); an 
explanation of how the product complies with applicable tobacco product 
standards; samples of the product and its components; and labeling.
    FDA also encourages persons who would like to study their new 
tobacco product to meet with the Office of Science (OS) in the Center 
for Tobacco Products (CTP) to discuss their investigational plan. The 
request for a meeting should be sent in writing to the Director of 
CTP's Office of Science and should include adequate information for FDA 
to assess the potential utility of the meeting and to identify FDA 
staff necessary to discuss agenda items. The following web page details 
the process for requesting a meeting with OS and how FDA will respond: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/meetings-industry-and-investigators-research-and-development-tobacco-products.
    FDA efforts regarding issuance of a final guidance for Harmful and 
Potentially Harmful Constituent reporting (and later a testing and 
reporting regulation under section 915 of the FD&C Act) is ongoing, and 
the guidance document will be issued consistent with our Good Guidance 
Practice regulations found in 21 CFR 10.115, which provide for public 
comment at any time.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
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Obtaining an FDA Order                       200            3.75             750           1,713       1,284,750
 Authorizing Marketing of
 Tobacco Product (PTMA
 application) and 21 CFR 25.40
 Environmental Assessments......
Request for Meeting with CTP's                27               1              27              10             270
 Office of Science to Discuss
 Investigational Plan...........
Sec.   1143 Cigar Warning Plans.               1               1               1               1               1
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    Total.......................  ..............  ..............  ..............  ..............       1,285,021
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates an average burden per respondent of 1,500 hours to 
prepare a PMTA seeking an order from FDA allowing the marketing of a 
new tobacco product. We assume, on average, an additional 213 hours is 
necessary to prepare an environmental assessment in accordance with the 
requirements of 21 CFR 25.40, for a total of 1,713 hours per PMTA 
application. This average represents a wide range of hours that will be 
required for these applications

[[Page 25282]]

under different circumstances, with a small number requiring more hours 
(e.g., as many as 5,000 hours for early applications that involve 
complex products and for which the company has no experience conducting 
studies or preparing analysis of public health impacts, or for which 
reliance on master files is not possible) as well as many requiring 
fewer hours (e.g., as few as 50 hours for applications for products 
that are very similar to other new products). A PMTA may require one or 
more types of studies including chemical analysis, nonclinical studies, 
and clinical studies. FDA also estimates the number of PMTAs that FDA 
expects to receive annually will be 750 (642 electronic nicotine 
delivery systems (ENDS) Liquids and 108 ENDS Delivery Systems).
    FDA anticipates that the 27 potential respondents to this 
collection may need to meet with CTP's Office of Science to discuss 
their investigational plans. This number has been reduced based on the 
average number of meeting requests received over the past 3 years. To 
request this meeting, applicants should compile and submit information 
to FDA for meeting approval. FDA estimates that it will take 
approximately 270 hours to compile and request a meeting with OS. We 
have revised the hours per response to be consistent with the meetings 
information collection for originally regulated products (OMB control 
number 0910-0731).
    Based on the September 2020 order vacating the health warning 
requirements for cigars and pipe tobacco (set forth in Sec. Sec.  
1143.3 and 1143.5) and remanding the Final Deeming Rule's warning 
requirements for cigars and pipe tobacco, we have removed the burden 
associated with this activity. We have included one token hour of 
burden associated with the requirements in Sec.  1143 to acknowledge 
the requirement remains in the regulations.
    We have adjusted our burden estimate, which has resulted in a 
decrease to the currently approved burden. The total estimated burden 
for this information collection is 1,285,021 reporting hours, and 778 
annual responses. Our estimated burden for the information collection 
reflects an overall decrease of 2,779 hours and a corresponding 
decrease of 262 responses. We attribute this adjustment to updated 
information in the number of meeting requests with CTP's Office of 
Science to discuss investigational plans, the removal of burden for the 
cigar warning plans, the removal of the small-scale manufacturer 
reporting, and have therefore revised the estimated burden and number 
of respondents to the information collection.

    Dated: April 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09072 Filed 4-27-22; 8:45 am]
BILLING CODE 4164-01-P