Notice2022-14931
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
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Published
July 13, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA 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.
Full Text
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<title>Federal Register, Volume 87 Issue 133 (Wednesday, July 13, 2022)</title>
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[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Pages 41730-41732]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14931]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0049]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reporting Harmful and
Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
Under 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 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 12, 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 Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0732. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St. North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#1b4b495a486f7a7d7d5b7d7f7a35737368357c746d"><span class="__cf_email__" data-cfemail="3d6d6f7c6e495c5b5b7d5b595c1355554e135a524b">[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.
Reporting Harmful and Potentially Harmful Constituents in Tobacco
Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic
Act
OMB Control Number 0910-0732--Extension
The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (Tobacco Control Act), enacted on June 22, 2009, amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and provided FDA with
the authority to regulate the manufacture, marketing, and distribution
of cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and
smokeless tobacco products to protect the public health and to reduce
tobacco use by minors. The Tobacco Control Act also gave FDA the
authority to issue regulations deeming other products that meet the
statutory definition of a tobacco product to be subject to chapter IX
of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))).
In accordance with that authority, on May 10, 2016, FDA issued a
final rule deeming all products that meet the statutory definition of
tobacco product, except accessories of newly deemed tobacco products,
to be subject to FDA's tobacco product authority (final deeming rule)
(81 FR 28974).
Chapter IX of the FD&C Act now applies to newly regulated products,
including sections 904(a)(3) and (c)(1) (21 U.S.C. 387d(a)(3) and
(c)(1)). Section 904(a)(3) of the FD&C Act requires the submission of
an initial report from each tobacco product manufacturer or importer,
or agents thereof, listing all constituents, including smoke
constituents as applicable, identified as a harmful and potentially
harmful constituent (HPHC) to health by FDA. Reports must be by brand
and by quantity in each brand and subbrand. We note that for
cigarettes, smokeless tobacco, cigarette filler, and RYO tobacco
products, this initial reporting was completed in 2012.
Section 904(c)(1) of the FD&C Act provides that manufacturers of
tobacco products not on the market as of June 22, 2009, must also
provide the information reportable under section 904(a)(3) of the FD&C
Act at least 90 days prior to introducing the product into interstate
commerce.
FDA has taken several steps to identify HPHCs to be reported under
section 904 of the FD&C Act, including issuing a guidance discussing
FDA's current thinking on the meaning of the term ``harmful and
potentially harmful constituent'' in the context of implementing the
HPHC list requirement under section 904(e) of the FD&C Act (76 FR 5387,
January 31, 2011, revised guidance issued August 2016). The guidance is
available on the internet at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/harmful-and-potentially-harmful-constituents-tobacco-products-used-section-904e-federal-food-drug">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/harmful-and-potentially-harmful-constituents-tobacco-products-used-section-904e-federal-food-drug</a>. The current established list of HPHCs also is available on the
internet at <a href="https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list">https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list</a> (77 FR 20034, April 3, 2012).
The purpose of the information collection is to collect statutorily
mandated information regarding HPHCs in certain tobacco products and
tobacco smoke, by brand and by quantity in each brand and subbrand.
To facilitate the submission of HPHC information, Forms FDA 3787a-
j, for cigarettes, smokeless tobacco products, and RYO tobacco
products, respectively, in both paper and electronic formats, are
available. Additionally, FDA is developing forms to facilitate the
submission of HPHC information for the deemed tobacco products. We
intend to model these forms on the current HPHC reporting forms (i.e.,
Forms FDA 3787a-j). A proposed information collection for deemed
products will be published in a separate Federal Register notice, and
we will solicit comments on that collection at that time.
Manufacturers or importers, or their agents, may submit HPHC
information either electronically or in paper format. The FDA
eSubmitter tool, available at https://www.fda.gov/industry/fda-
[[Page 41731]]
esubmitter/using-esubmitter-prepare-tobacco-product-submissions,
provides electronic forms to streamline the data entry and submission
process for reporting HPHCs for cigarettes, smokeless tobacco products,
and RYO tobacco products. Users of eSubmitter may populate an FDA-
created Excel file and import data into eSubmitter. Whether respondents
decide to submit reports electronically or on paper, each form provides
instructions for completing and submitting HPHC information to FDA. The
forms contain fields for company information, product information, and
HPHC information.
In the Federal Register of February 7, 2022 (87 FR 6869), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We have adjusted estimates in the number of respondents and
responses per respondent from the 60-day Federal Register notice to
better align with previous assessments that utilized the number of
entities. The number of respondents now reflects the estimated number
of cigarettes, RYO, and smokeless tobacco product manufacturers,
importers, or their agents. The burden totals were unchanged from the
60-day notice.
FDA estimates the burden of this collection of information as
follows:
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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Reporting for Section 904(c)(1) Products
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1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
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Cigarette..................... 48 7.92 380 1.82 692
RYO........................... 43 0.44 19 0.43 8
Smokeless..................... 34 0.74 25 0.63 16
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Total..................... .............. .............. .............. .............. 716
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2. Testing of HPHC Quantities in Products
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Cigarette Filler and RYO...... 43 0.44 19 9.42 179
Smokeless..................... 34 0.74 25 12.06 302
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Total..................... .............. .............. .............. .............. 481
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3. Testing of HPHC Quantities in Mainstream Smoke
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Cigarette: ISO Regimen........ 48 7.92 380 23.64 8,983
Cigarette: Health Canada 48 7.92 380 23.64 8,983
Regimen......................
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Total..................... .............. .............. .............. .............. 17,996
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Total Section .............. .............. .............. .............. 19,193
904(c)(1) Reporting
Burden Hours.........
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimate for this collection of information includes the
time it will take to read the instructions, test the products, and
prepare the HPHC report. In arriving at this burden estimate, FDA
estimated the number of tobacco products to be reported under the
requirements of section 904(c)(1) of the FD&C Act annually to FDA.
Section 1 of Table 1 estimates that 125 respondents (48 cigarette,
43 RYO, and 34 smokeless tobacco product manufacturers, importers, or
their agents) will submit 424 HPHC reports annually. Each respondent
must report their product information to FDA under section 904(c)(1) of
the FD&C Act at least 90 days prior to delivery for introduction into
interstate commerce for all new products. We have adjusted information
in the number of respondents and responses per respondent from the 60-
day Federal Register notice to better align with previous assessments.
The number of respondents now reflects the estimated number of
cigarettes, RYO, and smokeless tobacco product manufacturers,
importers, or their agents. This section addresses the time required to
report their company information to FDA using the electronic portal or
paper forms.
The company information reported includes company name; mailing
address; telephone and fax numbers; FDA Establishment Identifier
number; Data Universal Numbering System number; and point of contact
name, mailing address, and telephone and fax numbers, as applicable. It
also addresses the time required for manufacturers and importers to
report their product information by entering certain testing
information into the electronic or paper forms.
The product information includes brand and subbrand name; unique
product identification number; type of product identification number;
product category and subcategory; and mean weight and standard
deviation of tobacco in product.
We estimate that the burden to enter both the company and product
information is no more than 1.82 hours per response for cigarettes,
0.43 hours per response for RYO, and 0.63 hours per response for
smokeless tobacco products regardless of whether the paper or
electronic Form FDA series 3787 is used. The time to report per tobacco
product types varies because the number of HPHCs varies by tobacco
product category. The total hours estimated for this section is 716.
The estimated total annual responses under section 904(c)(1) are
based on FDA's experience and the past 4 years of tobacco products
receiving marketing authorizations from FDA, and the requirements to
submit HPHC data
[[Page 41732]]
under this provision of the FD&C Act for statutorily regulated
products.
Section 2 of Table 1 estimates that 77 respondents (43 cigarette
filler and RYO tobacco and 34 smokeless manufacturers, importers, or
their agents) will test quantities of HPHCs in an average of 44
products annually. This section addresses the time required for
manufacturers and importers (or their agents) who must test HPHC
quantities in products. The burden estimates include the burden to test
the tobacco products, draft testing reports, and submit the report to
FDA. The total expected burden for this section is 481 hours.
Section 3 of Table 1 addresses the time required for manufacturers
and importers to test quantities for HPHCs in cigarette smoke. The
burden estimates include: the burden to test the number of replicate
measurements; test date range; manufacture date range; extraction
method; separation method; detection method; and mean quantity and
standard deviation of HPHCs and includes the burden to test the tobacco
products, draft testing reports, and submit the report to FDA. The
annual burden reflects our estimate of the time it takes to test the
tobacco products (i.e., carry out laboratory work). The burden estimate
assumes that manufacturers and importers report HPHC quantities in
cigarette mainstream smoke according to both the ISO and Health Canada
smoking regimens. The total expected burden is 17,996 hours for this
section.
The total estimated burden for this information collection is
expected to be 19,193 hours and 424 annual responses. Our estimated
burden for the information collection reflects an overall increase of
354 annual responses and a corresponding increase of 16,677 hours. We
attribute this adjustment to updated methodology in which the current
estimates are derived from historical statutory tobacco product
applications submitted and authorized by FDA in the past 4 years as:
(1) manufacturers and importers (or their agents) of authorized
products are required to submit HPHC reports at least 90 days prior to
delivery for introduction into interstate commerce for all new
products; and (2) initial reporting under section 904(a)(3) of the FD&C
Act for statutory products was completed in 2012.
Dated: July 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14931 Filed 7-12-22; 8:45 am]
BILLING CODE 4164-01-P
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