
[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 744-747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00448]


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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 or Agency) 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 (HPHCs).

DATES: Submit either electronic or written comments on the collection 
of information by April 1, 2019.

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 1, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 1, 2019. 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

[[Page 745]]

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 ``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.
     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.gpo.gov/fdsys/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.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 (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 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

[[Page 746]]

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/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm. The current 
established list of HPHCs also is available on the internet at https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM297828.pdf (77 FR 20034, April 3, 2012).
    The purpose of the information collection is to collect statutorily 
mandated information regarding HPHCs in 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, 
3787b, and 3787c 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 newly deemed tobacco products. 
We intend to model these forms on the current HPHC reporting forms 
(i.e., Forms FDA 3787a, 3787b, and 3787c). A proposed information 
collection for newly 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 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.......................              67            0.67              45            1.82              82
RYO.............................              46           0.033             1.5            0.43               1
Smokeless.......................              42            0.54              23            0.63              14
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................  ..............  ..............  ..............  ..............              97
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                                    2. Testing of HPHC Quantities in Products
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Cigarette Filler and RYO........              46           0.033             1.5            9.42              14
Smokeless.......................              42            0.54              23           12.06             277
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................  ..............  ..............  ..............  ..............             291
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                                3. Testing of HPHC Quantities in Mainstream Smoke
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Cigarette: ISO Regimen..........              67            0.67              45           23.64           1,064
Cigarette: Health Canada Regimen              67            0.67              45           23.64           1,064
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................  ..............  ..............  ..............  ..............           2,128
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        Total Section 904(c)(1)   ..............  ..............  ..............  ..............           2,516
         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 
2,516 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 155 respondents (67 cigarette 
manufacturers or importers, 46 RYO tobacco manufacturers, 42 smokeless 
manufacturers) will submit 97 HPHC reports annually. This section 
addresses the time required for manufacturers and importers (or their 
agents), who must report their product information to FDA

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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, 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 for cigarettes, 0.43 hours for 
RYO, and 0.63 hours 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 estimated number of responses under section 904(c)(1) is based 
on FDA's experience and the past 3 years' actual responses to FDA under 
this provision of the FD&C Act for statutorily regulated products.
    Section 2 of table 1 estimates that 88 respondents (46 cigarette 
filler and RYO tobacco manufacturers and importers and 42 smokeless 
manufacturers) will test quantities of HPHCs in an average of 24.5 
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 291 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 2,128 hours for this section.
    The total estimated burden for this information collection is 2,516 
hours and 139 responses.
    Our estimated burden for the information collection reflects an 
overall decrease of 2,125 hours and a corresponding decrease of 142 
responses. We attribute this decrease to updated information on the 
number of submissions we received over the last few years.

    Dated: January 11, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00448 Filed 1-30-19; 8:45 am]
 BILLING CODE 4164-01-P


