Notice2022-22299
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 198 (Friday, October 14, 2022)</title>
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[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62414-62416]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#015153405275606767416765602f6969722f666e77"><span class="__cf_email__" data-cfemail="702022312304111616301614115e1818035e171f06">[email protected]</span></a>.
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/meetings-industry-and-investigators-research-and-development-tobacco-products">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/meetings-industry-and-investigators-research-and-development-tobacco-products</a>.
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
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