[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Notices]
[Pages 70232-70235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28787]


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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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 the collection of information 
associated with the reporting of harmful and potentially harmful 
constituents in tobacco products and tobacco smoke under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the collection 
of information by January 12, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically,

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including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 the information collection request entitled 
``Reporting Harmful and Potentially Harmful Constituents in Tobacco 
Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic 
Act.'' Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
http://www.regulations.gov or at the Division of Dockets Management 
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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Pub. L. 111-31) into law. This law 
amended the FD&C Act and granted FDA authority to regulate the 
manufacture, marketing, and distribution of tobacco products to protect 
public health generally and to reduce tobacco use by minors. Section 
904(a)(3) of the FD&C Act (21 U.S.C. 387d(a)(3)) required each tobacco 
product manufacturer or importer, or an agent, to begin reporting to 
FDA no later than June 22, 2012, ``all constituents, including smoke 
constituents, identified by [FDA] as harmful or potentially harmful to 
health in each tobacco product, and as applicable in the smoke of each 
tobacco product.'' Reports must be by the brand and by quantity in each 
brand and subbrand. Section 904(c)(1) of the FD&C Act states that 
manufacturers of tobacco products not on the market as of June 22, 
2009, must also provide information reportable under section 904(a)(3) 
at least 90 days prior to introducing the product into interstate 
commerce.
    FDA has taken several steps to identify harmful and potentially 
harmful constituents (HPHCs) to be reported under sections 904(a)(3) 
and (c)(1) 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). The guidance is available on the Internet at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm.

[[Page 70234]]

In addition, in the Federal Register of April 3, 2012 (77 FR 20034), 
FDA published a notice (the HPHC list notice) announcing the 
established list of HPHCs as required by section 904(e) of the FD&C Act 
and describing the criteria we used in identifying the HPHCs for the 
established list. Previously, FDA sought comment on both the criteria 
that would be used to identify HPHCs for the established list and a 
list of chemicals and chemical compounds that met the proposed 
criteria.
    The purpose of the information collection is to collect statutorily 
mandated information regarding HPHCs in tobacco products and tobacco 
smoke, by quantity in each brand and subbrand.
    To facilitate the submission of HPHC information, FDA has developed 
Forms 3787a, 3787b, and 3787c in both paper and electronic formats. 
Manufacturers or importers, or their agents, may submit 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. 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. Respondents finished reporting initial HPHC 
information under section 904(a)(3) in 2012, and this collection of 
information is in connection with the reporting requirements under 
section 904(c)(1) of the FD&C Act for tobacco products introduced into 
interstate commerce after June 22, 2009.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
      Information collected          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 Company and Product Information by Completing Submission Forms
    Cigarette...................              78            0.79              62            1.82             113
    Roll-Your-Own...............              39            0.21               8            0.43               3
    Smokeless...................              52            0.21              11            0.63               7
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        Total...................  ..............  ..............  ..............  ..............             123
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                                    2. Testing of HPHC Quantities in Products
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    Cigarette Filler............              78            0.79              62            9.42             584
    Roll-Your-Own...............              39            0.21               8            9.42              75
    Smokeless...................              52            0.21              11           12.06             133
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        Total...................  ..............  ..............  ..............  ..............             792
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                                3. Testing of HPHC Quantities in Mainstream Smoke
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    Cigarette: International                  78            0.79              62           23.64           1,466
     Organization for
     Standardization (ISO)
     Regimen....................
    Cigarette: Health Canada                  78            0.79              62           23.64           1,466
     Regimen....................
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............           2,932
        Total Section 904(c)(1)   ..............  ..............  ..............  ..............           3,847
         Reporting Burden Hours.
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\1\ There are no capital costs or operating costs associated with this collection of information.

    Table 1 contains estimates for new product information received 
annually under section 904(c)(1) of the FD&C Act. Manufacturers must 
report HPHC information under section 904(c)(1) of the FD&C Act at 
least 90 days prior to delivery for introduction into interstate 
commerce. The total annual burden for this collection of information is 
estimated to be 3,847 hours. The burden estimate for this collection of 
information includes the time it will take to test the products and 
prepare the HPHC report.
    Table 1 indicates that 169 respondents will submit HPHC reports 
when new products enter the market. Section 1 of the table addresses 
the time required for manufacturers to report their company 
information. We estimate that the time to report HPHC information is no 
more than 1.82 hours for cigarettes, 0.42 hours for roll-your-own, and 
0.63 hours for smokeless tobacco products for each response regardless 
of whether the paper or electronic form (Form FDA 3787) is used. (The 
estimated times to report smokeless tobacco products (0.63 hour) and 
roll-your-own tobacco products (0.43 hour) are lower than the estimated 
reporting time for cigarette products because fewer HPHCs are normally 
reported for these two types of products. The total annual burden for 
reporting company and product information is 123 hours.
    Section 2 of the table addresses the time required for 
manufacturers to test quantities of HPHCs in their products. The burden 
hour estimates include the time needed to test the tobacco products, 
draft testing reports, and draft the report for FDA. For cigarette 
filler, smokeless, and roll-your-own products, we estimate the burden 
to be 792 annual burden hours. The burden for each product type 
reflects our estimate of the time to test the tobacco products (i.e., 
carry out laboratory work).
    In addition to addressing the time required to report information 
and test quantities of HPHCs in tobacco products, section 3 of table 1 
addresses the time required for manufacturers to test quantities of 
HPHCs in cigarette smoke. The burden estimates include testing the 
tobacco products, drafting testing reports, and drafting the report for 
FDA. We estimate the annualized

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burden for this section to be 2,932 hours. The annual burden reflects 
our estimate to test the tobacco products (i.e., carry out laboratory 
work). The burden estimate assumes that manufacturers report HPHC 
quantities in cigarette mainstream smoke according to the two smoking 
regimens described in the table.
    The estimated total annual burden for the reporting of HPHC under 
section 904(c)(1) of the FD&C Act is 3,847 hours. We do not believe 
there are any capital costs associated with this collection.

    Dated: November 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28787 Filed 11-12-15; 8:45 am]
BILLING CODE 4164-01-P