[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Pages 26121-26123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by July 5, 
2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0673. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

OMB Control Number 0910-0673--Extension

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Tobacco Control Act) (Pub. L. 111-31) was signed 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, generally 
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

[[Page 26122]]

tobacco product or find the product exempt from the requirements of 
substantial equivalence under section 910(a)(2)(A) of the FD&C Act (21 
U.S.C. 387j(a)(2)(A)) before the product may be introduced into 
commercial distribution (section 910 of the FD&C Act).
    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) of the FD&C Act (21 U.S.C. 387a(b))). 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'').
    The FD&C Act authorizes three premarket pathways for a new tobacco 
product to legally enter the market. 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 pathway. 
Under section 905(j)(1)(A)(i) of the FD&C Act (21 U.S.C. 
387e(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 of Health and Human Services has 
previously determined, under 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 as 
required under section 905(j)(1)(A)(i) of the FD&C Act. FDA's guidance 
entitled ``Demonstrating the Substantial Equivalence of a New Tobacco 
Product: Responses to Frequently Asked Questions'' (December 2016) 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 Substantial Equivalence 
(SE) Report for certain modifications that should be easier for 
manufacturers to prepare.
    In the Federal Register of September 6, 2018 (83 FR 45251), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received seven comments that were PRA 
related. Commenters noted that the burden estimates seem low given 
current experience and rounds of review by FDA, but that FDA could 
reduce the current burden by increasing transparency in the SE process 
by issuing a rulemaking related to SE. These comments concerned the 
burdens related to the SE program and noted that lack of a rule related 
to the SE pathway has contributed to that burden. In addition, 
commenters stated that lack of clarity on the content of SE Reports, 
including the lack of clarity regarding the information that might be 
needed when a new tobacco product has ``same characteristics'' or 
``different characteristics,'' contributes to that burden.
    We believe that recent activities undertaken by FDA will help 
address these concerns and support maintaining the current estimates, 
which are averages of burden across a number of years. Specifically, in 
October 2018, FDA held a public workshop that provided industry 
stakeholders with additional information on SE content and process 
(https://www.fda.gov/TobaccoProducts/NewsEvents/ucm615443.htm). More 
recently, FDA issued a notice of proposed rulemaking related to the 
content and format of SE Reports (84 FR 12740, April 2, 2019), which 
would establish the required content of SE Reports and explain FDA 
review practices. This proposed rule also provides potential approaches 
to addressing same characteristics and different characteristics, along 
with examples, and considerations FDA may evaluate in determining 
whether difference(s) in characteristics cause the new tobacco product 
to raise different questions of public health. FDA is seeking comment 
on that proposed rule.
    In addition, we note that several of the commenters are cigar 
industry stakeholders who indicated that submissions may be higher for 
cigar products than our current estimates reflect, and we acknowledge 
that future collections may be further refined to reflect changes in 
numbers of submissions due to more SE submissions for cigar products 
related to the Deeming final rule.
    FDA estimates the burden of this collection of information as 
follows:

                                 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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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......................
                                 -------------------------------------------------------------------------------
    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.

[[Page 26123]]

    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 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 each year.
    In addition, we estimate receiving 456 Full SE Bundled Reports at 
90 hours per submission for a total of 41,040 hours each year.
    FDA estimates that it will receive 239 Product Quantity Change SE 
Reports each year 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 each year 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 accounted for.
    Therefore, FDA estimates the annual 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: May 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11657 Filed 6-4-19; 8:45 am]
 BILLING CODE 4164-01-P


