Document ID: FDA-2012-D-0049-0042
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2022-07-13T04:00Z

[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Pages 41730-41732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[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.

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/harmful-and-potentially-harmful-constituents-tobacco-products-used-section-904e-federal-food-drug. The current established list of HPHCs also is available on the 
internet at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list (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\
----------------------------------------------------------------------------------------------------------------
                                                   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
----------------------------------------------------------------------------------------------------------------
Cigarette.....................              48            7.92             380            1.82               692
RYO...........................              43            0.44              19            0.43                 8
Smokeless.....................              34            0.74              25            0.63                16
                               ---------------------------------------------------------------------------------
    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
                               ---------------------------------------------------------------------------------
    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......................
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ..............            17,996
                               ---------------------------------------------------------------------------------
        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