Document ID: FDA-2012-D-0049-0040
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
Posted Date: 2022-02-07T05:00Z

[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Notices]
[Pages 6869-6872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02478]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0049]

Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) 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 Reporting Harmful and 
Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke 
Under the Federal Food, Drug, and Cosmetic Act.

DATES: Submit either electronic or written comments on the collection 
of information by April 8, 2022.

[[Page 6870]]

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 April 8, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 8, 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-2012-D-0049 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Reporting Harmful and Potentially 
Harmful Constituents in Tobacco Products and Tobacco Smoke Under 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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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.

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

[[Page 6871]]

(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) at least 90 
days prior to introducing the product into interstate commerce.\1\
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    \1\ Note that section 904(c)(1) testing and reporting 
requirements are separate from the requirements that must be 
satisfied before a new tobacco product (sections 905 and 910 of the 
FD&C Act (21 U.S.C. 387e and 387j)), or modified risk tobacco 
product (section 911 of the FD&C Act (21 U.S.C. 387k)) may be 
marketed.
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    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-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.
    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.......................             380               1             380            1.82             692
RYO.............................              19               1              19            0.43               8
Smokeless.......................              25               1              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........              19               1              19            9.42             179
Smokeless.......................              25               1              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..........             380               1             380           23.64           8,983
Cigarette: Health Canada Regimen             380               1             380           23.64           8,983
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    Total.......................  ..............  ..............  ..............  ..............          17,996
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[[Page 6872]]

 
        Total Section 904(c)(1)   ..............  ..............  ..............  ..............          19,193
         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 for this collection of information is estimated to be 
19,193 hours. 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 424 respondents (380 cigarettes 
receiving authorizations, 19 RYO tobacco receiving authorizations, 25 
smokeless receiving authorizations) will submit 424 HPHC reports 
annually. Each respondent represents a statutory tobacco product that 
receives authorization from FDA for which manufacturers and importers 
(or their agents), 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. This 
section addresses the time required to report their company information 
to FDA through the use of 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 number of responses under section 904(c)(1) of the 
FD&C Act is based on FDA's experience, the past 4 years of tobacco 
products receiving marketing authorizations from FDA, and actual 
responses to FDA under this provision of the FD&C Act for statutorily 
regulated products.
    Section 2 of table 1 estimates that 44 respondents (19 cigarette 
filler and RYO tobacco receiving authorizations and 25 smokeless 
receiving authorizations) 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 the two smoking regimens. The 
total expected burden is 17,996 hours for this section.
    The total estimated burden for this information collection is 
19,193 hours and 424 respondents. Our estimated burden for the 
information collection reflects an overall increase of 269 respondents 
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: February 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02478 Filed 2-4-22; 8:45 am]
BILLING CODE 4164-01-P