[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3158-3161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0071]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Draft Guidance for Industry: Modified Risk Tobacco 
Product Applications

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 collection of information, and to allow 60 days for 
public comment in response to the notice. This notice solicits comments 
on ``Draft Guidance for Industry: Modified Risk Tobacco Product 
Applications'' (MRTPA).

DATES: Submit either electronic or written comments on the collection 
of information by March 26, 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 March 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of March 26, 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-2012-D-0071 for ``Draft Guidance for Industry: Modified Risk 
Tobacco Product Applications'' 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,

[[Page 3159]]

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 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.

Draft Guidance for Industry: Modified Risk Tobacco Product Applications

OMB Control Number 0910--NEW

    In the Federal Register of April 3, 2012 (77 FR 20026), FDA 
published a notice of availability including the PRA analysis. FDA is 
republishing the paperwork analysis with updates to satisfy the 
requirements of the PRA.
    This draft guidance describes the information that the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) requires in an MRTPA submission 
as well as FDA's recommendations regarding the scientific evidence that 
should be contained in a MRTPA for FDA to make an assessment and 
conduct an ongoing review of modified risk tobacco products (MRTPs). 
The draft guidance also permits the filing of a single application for 
any MRTP that is also a new tobacco product under section 910 of the 
FD&C Act (21 U.S.C. 387k). The draft guidance discusses, among other 
things: (1) Who submits MRTPAs; (2) when to submit a MRTPA; (3) what 
information section 911 of the FD&C Act (21 U.S.C. 387j) requires 
applicants to submit in a MRTPA; (4) what scientific evidence FDA 
recommends applicants include in a MRTPA; (5) what information should 
be collected through postmarket surveillance and studies; and (6) how 
to organize and submit a MRTPA. The purpose of the proposed information 
collection is to allow FDA to collect statutorily mandated information 
regarding modified risk tobacco products and other information that 
will facilitate FDA's effective and efficient review of MRTPAs.
    Modified risk tobacco products are tobacco products that are sold 
or distributed for use to reduce harm or the risk of tobacco-related 
disease associated with commercially marketed tobacco products (section 
911(b)(1) of the FD&C Act). No person may introduce or deliver for 
introduction into interstate commerce any MRTP unless an order issued 
pursuant to section 911(g) is effective with respect to that product 
(section 911(a) of the FD&C Act).
    Under section 911(d) of the FD&C Act, a MRTPA must contain:
     A description of the proposed product and any proposed 
advertising and labeling;
     The conditions for using the product;
     The formulation of the product;
     Sample product labels and labeling;
     All documents (including underlying scientific 
information) relating to research findings conducted, supported, or 
possessed by the tobacco product manufacturer relating to the effect of 
the product on tobacco-related diseases and health-related conditions, 
including information both favorable and unfavorable to the ability of 
the product to reduce risk or exposure and relating to human health;
     Data and information on how consumers actually use the 
tobacco product; and
     Such other information as the Secretary may require.
    Further, FDA's regulation implementing the National Environmental 
Policy Act of 1969 requires that ``[a]ll applications or petitions 
requesting agency action require the submission of an [environmental 
assessment] or a claim of categorical exclusion'' (21 CFR 25.15(a)).
    Section 911(g) of the FD&C Act describes the demonstrations 
applicants must make to obtain an order from FDA. Section 911(g)(1) and 
(2) of the FD&C Act set forth two bases for FDA to issue an order.
    A ``risk modification order'' is an order permitting the 
introduction or delivery for introduction into interstate commerce of a 
tobacco product that FDA has found meets the criteria for an order 
under section 911(g)(1) of the FD&C Act. In order for FDA to issue a 
risk modification order under section 911(g)(1) of the FD&C Act, the 
applicant must demonstrate that the proposed modified risk tobacco 
product, as it is actually used by consumers, will:
     Significantly reduce harm and the risk of tobacco-related 
disease to individual tobacco users and
     Benefit the health of the population as a whole taking 
into account both users of tobacco products and persons who do not 
currently use tobacco products.
    An ``exposure modification order'' is an order permitting the 
introduction or delivery for introduction into interstate commerce of a 
tobacco product that reduces or eliminates exposure to a substance and 
for which the available scientific evidence suggests that a measurable 
and substantial reduction in morbidity and mortality is likely to be 
demonstrated in future studies. In order for FDA to issue an exposure 
modification order, the applicant must satisfy all of the criteria for 
issuance of an order under section 911(g)(2) of the FD&C Act.
    FDA may issue an exposure modification order under section 
911(g)(2) of the FD&C Act (the ``special rule'') if it determines that 
the applicant has demonstrated that:
     Such an order would be appropriate to promote the public 
health;
     Any aspect of the label, labeling, and advertising for the 
product that would cause the product to be a MRTP is limited to an 
explicit or implicit representation that the tobacco product or its 
smoke does not contain or is free of a substance or contains a reduced 
level of a substance, or presents a reduced exposure to a substance in 
tobacco smoke;
     Scientific evidence is not available and, using the best 
available scientific methods, cannot be made available without 
conducting long-term epidemiological studies for an application to meet 
the standards for obtaining an order under section 911(g)(1); and
     The scientific evidence that is available without 
conducting long-term epidemiological studies demonstrates

[[Page 3160]]

that a measurable and substantial reduction in morbidity or mortality 
among individual tobacco users is reasonably likely in subsequent 
studies (section 911(g)(2)(A) of the FD&C Act).
    Furthermore, for FDA to issue an exposure modification order, FDA 
must find that the applicant has demonstrated that:
     The magnitude of overall reductions in exposure to the 
substance or substances, which are the subject of the application is 
substantial, such substance or substances are harmful, and the product 
as actually used exposes consumers to the specified reduced level of 
the substance or substances;
     The product as actually used by consumers will not expose 
them to higher levels of other harmful substances compared to the 
similar types of tobacco products then on the market unless such 
increases are minimal and the reasonably likely overall impact of use 
of the product remains a substantial and measurable reduction in 
overall morbidity and mortality among individual tobacco users;
     Testing of actual consumer perception shows that, as the 
applicant proposes to label and market the product, consumers will not 
be misled into believing that the product is or has been demonstrated 
to be less harmful, or presents or has been demonstrated to present 
less of a risk of disease than one or more other commercially marketed 
tobacco products; and
     Issuance of the exposure modification order is expected to 
benefit the health of the population as a whole taking into account 
both users of tobacco products and persons who do not currently use 
tobacco products (section 911(g)(2)(B) of the FD&C Act).
    In evaluating the benefit to health of individuals and of the 
population as a whole under section 911(g)(1) and (2) of the FD&C Act, 
FDA must take into account:
     The relative health risks the MRTP presents to 
individuals;
     The increased or decreased likelihood that existing 
tobacco product users who would otherwise stop using such products will 
switch to using the modified risk tobacco product;
     The increased or decreased likelihood that persons who do 
not use tobacco products will start using the modified risk tobacco 
product;
     The risks and benefits to persons from the use of the MRTP 
compared to the use of smoking cessation drug or device products 
approved by FDA to treat nicotine dependence; and
     Comments, data, and information submitted to FDA by 
interested persons (section 911(g)(4) of the FD&C Act).
    Furthermore, FDA must ensure that the advertising and labeling of 
the MRTP enable the public to comprehend the information concerning 
modified risk and to understand the relative significance of such 
information in the context of total health and in relation to all of 
the tobacco-related diseases and health conditions (section 911(h)(1) 
of the FD&C Act).
    FDA intends to determine whether it will issue an order under 
section 911(g) within 360 days after the receipt of a complete 
application and will issue such an order only if the application 
satisfies all the applicable requirements in section 911 of the FD&C 
Act.
    A risk modification order issued under section 911(g)(1) will be 
effective for the period of time specified in the order issued by FDA 
(section 911(h)(4) of the FD&C Act). An applicant to whom a risk 
modification order is issued under section 911(g)(1) must conduct 
postmarket surveillance and studies (section 911(i)(1) of the FD&C 
Act).
    An exposure modification order issued under section 911(g)(2) of 
the FD&C Act will be effective for a term of not more than 5 years. FDA 
may renew an exposure modification order if the applicant files a new 
application, and FDA finds that the requirements for such order under 
section 911(g)(2) continue to be satisfied (section 911(g)(2)(C)(i) of 
the FD&C Act). Further, an exposure modification order will be 
conditioned on the applicant's agreement to conduct postmarket 
surveillance and studies and to submit the results of such surveillance 
and studies to FDA annually (section 911(g)(2)(C)(ii) and (iii) of the 
FD&C Act).
    The postmarket surveillance and studies that all applicants who 
receive orders are required to conduct are intended to determine the 
effect of issuance of an order on consumer perception, behavior, and 
health, and enable FDA to review the accuracy of the determinations 
upon which an order was based (section 911(g)(2)(C)(ii) and 911(i)(1) 
of the FD&C Act). An applicant who receives a risk modification order 
must also conduct postmarket surveillance and studies that provide 
information FDA determines is otherwise necessary regarding the use or 
health risks involving the tobacco product (section 911(i)(1) of the 
FD&C Act).
    If the proposed MRTP is a new tobacco product within the meaning of 
section 910(a)(1), the new tobacco product must satisfy any applicable 
premarket review requirements under section 910 of the FD&C Act, in 
addition to any requirements under section 911 of the FD&C Act. A new 
tobacco product must be found to be substantially equivalent, exempt 
from the requirement to obtain a substantial equivalence determination, 
or have a marketing authorization order under section 910(c)(1)(A)(i) 
of the FD&C Act. The collections of information relating to premarket 
review described in the ``Guidance for Industry: Section 905(j) 
Reports: Demonstrating Substantial Evidence for Tobacco Products'' (OMB 
control number 0910-0673), 21 CFR part 1107 (``Establishment 
Registration, Product Listing, and Substantial Equivalence Reports'') 
(OMB control number 0910-0684), and ``Deeming Tobacco Products To Be 
Subject to the FD&C Act '' (OMB control number 0910-0768) have been 
previously approved by OMB. An applicant may file the appropriate 
report or application to satisfy any applicable premarket review 
requirements and a separate application under section 911 of the FD&C 
Act. To the extent data or information contained in the premarket 
review portion of the application is also relevant to or required for 
the modified risk determination, FDA encourages the applicant to cross-
reference that data or information rather than duplicate it in the 
modified risk portion of the application. Additionally, due to the many 
similarities between the content requirements of sections 910(b)(1) 
(for premarket tobacco applications (PMTAs)) and 911(d) (for MRTPAs) of 
the FD&C Act, we recommend submitting a single application to seek both 
a marketing order under section 910 of the FD&C Act and a modified risk 
order under section 911 of the FD&C Act. The single application must 
include the information required for premarket review under section 
910(b) of the FD&C Act, as well as the information required to support 
issuance of an order under section 911(g) of the FD&C Act.
    Description of Respondents: The respondents to this collection of 
information are applicants who are responsible for creating and 
submitting MRTP applications and who wish to obtain an FDA order to 
allow them to market their product. While it is expected that many of 
the respondents will be manufacturers, respondents could include 
importers, distributors, and retailers of tobacco products.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 3161]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
            Activity                 Number of    responses  per   Total annual     burden per      Total hours
                                    respondents      respondent      responses       response
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MRTPA (section 911(d) of FD&C                  3               1               3          10,000          30,000
 Act)...........................
Environmental analysis (21 CFR                 3               1               3             320             960
 25.15).........................
Request for a meeting prior to                 8               1               8              40             320
 submitting a MRTPA.............
All activities related to                      5               1               5           5,000          25,000
 postmarket surveillance
 studies, including submission
 of protocols, conduct of
 studies, and annual reporting
 (section 911(g)(2)(C)(ii),
 911(i)(1) and (2)).............
Requests for renewal (section                  1               1               1           1,000           1,000
 911(g)(2)(C)(i) and 911(h)(4)).
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    Total Hours.................  ..............  ..............  ..............  ..............          57,280
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 1 describes the annual reporting burden as a result of 
submitting a MRTPA. FDA estimates that it will receive three MPRTAs 
annually and that it will take the applicant 10,000 hours per response 
to conduct studies and collect the information needed to support an 
MRTPA. FDA is also including an estimation of the burden associated 
with preparing environmental analyses. FDA estimates that it will take 
an additional 320 hours to prepare any environmental analyses. FDA 
encourages persons considering developing a MRTPA to meet with the 
Center for Tobacco Products to discuss MRTPA submission and 
investigational requirements. FDA anticipates that eight respondents 
considering developing MRTPAs may request meetings with FDA. FDA 
estimates it will take 40 hours per response to prepare a meeting 
request, including background information.
    Section 911 of the FD&C Act requires applicants to whom FDA issues 
orders to conduct postmarket surveillance and studies and submit 
relevant information to FDA on an annual basis. Applicants must submit 
and receive FDA approval of surveillance protocols. FDA estimates that 
it will take 5,000 hours per response to collect and submit the 
protocol information to FDA, conduct the postmarket surveillance and 
studies and to submit results of postmarket surveillance and studies to 
FDA annually. FDA expects five respondents to carry out postmarket 
surveillance and studies annually.
    Because orders issued under section 911(g) of the FD&C Act are 
valid for only a set number of years, FDA expects applicants will 
submit requests for renewal. Because the dates on which orders are 
issued and the length of the period for which the order is valid will 
vary, FDA expects one request for renewal annually. FDA estimates that 
it will take 1,000 hours to prepare the request for renewal.
    The estimated total burden hours for this collection of information 
is estimated to be 57,280. These burden estimates were computed using 
FDA staff expertise and by reviewing comments received from recent FDA 
information collections for other tobacco-related initiatives. In 
addition, FDA notes that due to the many similarities between the 
content requirements of sections 910(b)(1) (from PMTAs) and 911(d) (for 
MRTPAs) of the FD&C Act, and the likelihood that many respondents will 
submit joint PMTAs and MRTPAs, or cross-reference the applications, 
that part of the collection of information burden for respondents 
submitting an MRTPA will be captured in the preparation of the PMTA.

    Dated: January 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01121 Filed 1-22-18; 8:45 am]
 BILLING CODE 4164-01-P