Document ID: FDA-2019-N-0305-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products Subject to the Federal Food, Drug, and Cosmetic Act
Posted Date: 2022-10-14T04:00Z

[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62414-62416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22299]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 November 14, 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

[[Page 62415]]

Review--Open for Public Comments'' or by using the search function. The 
OMB control number for this information collection is 0910-0768. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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 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 (parts 1100 through 1150 (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 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) (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. Details regarding the process 
for requesting a meeting with OS and how FDA will respond may be found 
at 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.
    In the Federal Register of April 28, 2022 (87 FR 25280) we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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 (PMTA
 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...........
21 CFR part 1143 Cigar Warning                 1               1               1               1               1
 Plans..........................
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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 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).

[[Page 62416]]

    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 21 CFR 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 1 token hour of burden associated with 
the requirements in part 1143 to acknowledge that 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: October 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22299 Filed 10-13-22; 8:45 am]
BILLING CODE 4164-01-P