[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45251-45253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19353]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0147]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry and Food and Drug Administration 
Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence 
for Tobacco Products

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 ``Guidance for Industry and Food and Drug 
Administration Staff; Section 905(j) Reports: Demonstrating Substantial 
Equivalence for Tobacco Products.''

DATES: Submit either electronic or written comments on the collection 
of information by November 5, 2018.

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 November 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 5, 2018. 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-2011-D-0147 for ``Guidance for Industry and Food and Drug 
Administration Staff; Section 905(j) Reports: Demonstrating Substantial 
Equivalence for Tobacco Products.'' 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

[[Page 45252]]

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, 
[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.

Guidance for Industry and Food and Drug Administration Staff on Section 
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco 
Products

OMB Control Number 0910-0673--Extension

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act amended the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) by adding, among other things, a chapter 
granting FDA authority to regulate the manufacture, marketing, and 
distribution of tobacco products to protect the public health generally 
and to reduce tobacco use by minors.
    The FD&C Act, as amended by the Tobacco Control Act, requires that 
before a new tobacco product may be introduced or delivered for 
introduction into interstate commerce, the new tobacco product must 
undergo premarket review by FDA. FDA must issue an order authorizing 
the commercial distribution of the new tobacco product or find the 
product exempt from the requirements of substantial equivalence under 
section 910(a)(2)(A) of the FD&C Act, before the product may be 
introduced into commercial distribution (section 910 of the FD&C Act 
(21 U.S.C. 387j)).
    FDA has issued a guidance document containing recommendations for 
preparing substantial equivalence reports (SE Reports) under section 
905(j)(1)(A)(i). A tobacco product manufacturer must show that a new 
tobacco product is substantially equivalent, within the meaning of 
section 910, to a tobacco product commercially marketed (other than for 
test marketing) in the United States as of February 15, 2007, or to a 
tobacco product that the Secretary has previously determined, pursuant 
to subsection (a)(3) of section 910, is substantially equivalent and 
that it is in compliance with the requirements of the FD&C Act. The 
comparison product chosen by the tobacco product manufacturer is 
referred to by FDA as the predicate tobacco product.
    The guidance document associated with this collection of 
information contains recommendations on preparing reports intended to 
demonstrate substantial equivalence to a predicate tobacco product and 
compliance with the FD&C Act as required under section 905(j)(1)(A)(i). 
Submission of a section 905(j)(1)(A)(i) report intended to demonstrate 
substantial equivalence and, in response, an order from the Agency 
finding that the new tobacco product is substantially equivalent to a 
predicate tobacco product and in compliance with the requirements of 
the FD& C Act, is one means for a new tobacco product to legally enter 
the market. FDA's guidance entitled ``Demonstrating the Substantial 
Equivalence of a New Tobacco Product: Responses to Frequently Asked 
Questions'' (December 2016). This guidance may be accessed at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm). In that guidance, FDA recommends that certain 
modifications might be addressed in a ``Product Quantity Change 
Report,'' which is a more streamlined SE Reports for certain 
modifications that should be easier for manufacturers to prepare.
    The Tobacco Control Act also gave FDA the authority to issue a 
regulation deeming all 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) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10, 
2016, FDA issued that rule, extending FDA's tobacco product authority 
to all products that meet the definition of tobacco product in the law 
(except for accessories of newly regulated tobacco products), including 
electronic nicotine delivery systems, cigars, hookah, pipe tobacco, 
nicotine gels, dissolvables that were not already subject to the FD&C 
Act, and other tobacco products that may be developed in the future (81 
FR 28974 at 28976) (``the Deeming final rule'').
    FDA estimates the burden of this collection of information as 
follows:

[[Page 45253]]



                                 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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Full SE 905(j)(1)(A)(i) and                  683               1             683             300         204,900
 910(a).........................
Full SE 905(j)(1)(A)(i) and                  456               1             456              90          41,040
 910(a) Bundled.................
Product Quantity Change SE                   239               1             239              87          20,793
 Report.........................
Product Quantity Change Bundled              192               1             192              62          11,904
 SE Report......................
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    Total.......................  ..............  ..............  ..............  ..............         278,637
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's estimates are based on experience with SE Reports, initial 
updated deemed registration and listing data, interactions with the 
industry, and information related to other regulated products. The 
estimated number of SE Reports is expected to increase from an annual 
average of 979 to 1,570.
    When groups of full or product quantity change SE Reports have 
identical content, they may be bundled; when a group of similar reports 
are bundled, the subsequent bundled reports are expected to take less 
time to prepare than the initial report.
    FDA has based these estimates on information it now has available 
from interactions with the industry, information related to other 
regulated products, and FDA expectations regarding the tobacco 
industry's use of the section 905(j) pathway to market their products. 
Table 1 describes the annual reporting burden as a result of the 
implementation of the substantial equivalence requirements of sections 
905(j)(1)(A)(i) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)) for an 
SE application.
    FDA estimates that 683 respondents will prepare and submit 683 
section 905(j)(1)(A)(i) SE Reports each year. In addition, anyone 
submitting an SE Report is required to submit an environmental 
assessment (EA) under 21 CFR 25.40. The burden for environmental 
reports has been included in the burden per response for each type of 
SE report. Based on FDA's experience with EAs for currently regulated 
tobacco products, we expect industry to spend 80 hours to prepare an 
environmental assessment for a SE Report. Thus, FDA estimates that it 
will take a manufacturer approximately 300 hours per report to prepare 
an SE Report and the EA for a new tobacco product, which is a total of 
204,900 hours.
    In addition, we estimate receiving 456 Full SE Bundled Reports at 
90 hours per submission for a total of 41,040 hours.
    FDA estimates that it will receive 239 Product Quantity Change SE 
Reports and that it will take a manufacturer approximately 87 hours to 
prepare this report for a total of 20,793 hours. This includes time to 
prepare the environmental assessment, which FDA believes will take less 
time due to the typically more limited modification(s) included in a 
Product Quantity Change SE Report. We estimate receiving 192 Product 
Quantity Change Bundled SE Reports at approximately 62 hours per 
submission for a total of 11,904 hours, this number excludes the time 
for the initial SE Report which was previously account for.
    Therefore, FDA estimates the burden for submission of SE 
information will be 278,637 hours. This is an increase of 106,759 hours 
from the currently approved burden. We attribute this increase to an 
increase in the number of SE Reports we expect related to Deemed 
products (e.g., based on the initial registration and listing 
information).

    Dated: August 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19353 Filed 9-5-18; 8:45 am]
 BILLING CODE 4164-01-P


