Agency Information Collection Activities; Proposed Collection; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobacco Products, 46501-46504 [2018-19913]
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Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. General Description of the Committee
Duties
Food and Drug Administration
The Tobacco Products Scientific
Advisory Committee (the Committee)
advises the Commissioner of Food and
Drugs (the Commissioner) or designee in
discharging responsibilities related to
the regulation of tobacco products. The
Committee reviews and evaluates safety,
dependence, and health issues relating
to tobacco products and provides
appropriate advice, information, and
recommendations to the Commissioner.
[Docket No. FDA–2018–N–3263]
Request for Nominations for Voting
Members on the Tobacco Products
Scientific Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for members to serve on
the Tobacco Products Scientific
Advisory Committee, Office of Science,
Center for Tobacco Products.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
SUMMARY:
Nominations received on or
before November 13, 2018 will be given
first consideration for membership on
the Tobacco Products Scientific
Advisory Committee. Nominations
received after November 13, 2018 will
be considered for nomination to the
committee as later vacancies occur.
DATES:
All nominations for
membership should be sent
electronically by logging into the FDA
Advisory Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002.
ADDRESSES:
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FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, the primary contact is:
Caryn Cohen, Office of Science, Center
for Tobacco Products, Food and Drug
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993–0002, 1–877–287–1373 (choose
option 5), email: TPSAC@fda.hhs.gov.
Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
website at: https://www.fda.gov/
AdvisoryCommittees/default.htm.
FDA is
requesting nominations for voting
members on the Tobacco Products
Scientific Advisory Committee.
SUPPLEMENTARY INFORMATION:
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II. Criteria for Voting Members
The Committee consists of 12
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
individuals knowledgeable in the fields
of medicine, medical ethics, science, or
technology involving the manufacture,
evaluation, or use of tobacco products.
Almost all non-Federal members of this
committee serve as Special Government
Employees. The Committee includes
nine technically qualified voting
members, selected by the Commissioner
or designee. The nine voting members
include seven members who are
physicians, dentists, scientists, or
healthcare professionals practicing in
the area of oncology, pulmonology,
cardiology, toxicology, pharmacology,
addiction, or any other relevant
specialty. The nine voting members also
include one member who is an officer
or employee of a State or local
government or of the Federal
Government, and one member who is a
representative of the general public.
Almost all non-Federal members of this
committee serve as Special Government
Employees. Members will be invited to
serve for terms of up to 4 years.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will ask
potential candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
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46501
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19921 Filed 9–12–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1588]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Exemptions From
Substantial Equivalence Requirements
for Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 exemptions from
substantial equivalence requirements for
tobacco products.
DATES: Submit either electronic or
written comments on the collection of
information by November 13, 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 13,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 13, 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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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• 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–
2013–N–1588 for ‘‘Exemptions From
Substantial Equivalence Requirements
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
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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/201523389.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.
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.
SUPPLEMENTARY INFORMATION:
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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.
Exemptions From Substantial
Equivalence Requirements for Tobacco
Products
OMB Control Number 0910–0684—
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 a chapter granting
FDA important 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)).
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
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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, May 10, 2016) (‘‘the
final deeming rule’’)).
FDA has established a pathway for
manufacturers to request exemptions
from the substantial equivalence
requirements of the FD&C Act in
§ 1107.1 (21 CFR 1107.1) of the
Agency’s regulations. As described in
§ 1107.1(a), FDA may exempt tobacco
products that are modified by adding or
deleting a tobacco additive, or
increasing or decreasing the quantity of
an existing tobacco additive, from the
requirement of demonstrating
substantial equivalence if the Agency
determines that: (1) The modification
would be a minor modification of a
tobacco product that can be sold under
the FD&C Act; (2) a report
demonstrating substantial equivalence
is not necessary to ensure that
permitting the tobacco product to be
marketed would be appropriate for the
protection of public health; and (3) an
exemption is otherwise appropriate.
Section 1107.1(b) states that a request
for exemption under section 905(j)(3) of
the FD&C Act may be made only by the
manufacturer of a legally marketed
tobacco product for a minor
modification to that tobacco product
and that the manufacturer must submit
the request and all information
supporting it to FDA. The request must
be made in an electronic format that
FDA can process, review, and archive
(or a written request must be made by
the manufacturer explaining in detail
why the manufacturer cannot submit
the request in an electronic format and
requesting an alternative means of
submission to the electronic format).
An exemption request must contain:
(1) The manufacturer’s address and
contact information; (2) identification of
the tobacco product(s); (3) a detailed
explanation of the purpose for the
modification; (4) a detailed description
of the modification, including a
statement as to whether the
modification involves adding or
deleting a tobacco additive, or
increasing or decreasing the quantity of
the existing tobacco additive; (5) a
detailed explanation of why the
modification is a minor modification of
a tobacco product that can be sold under
the FD&C Act; (6) a detailed explanation
of why a report under section 905(j)(1)
of the FD&C Act intended to
demonstrate substantial equivalence is
not necessary to ensure that permitting
the tobacco product to be marketed
would be appropriate for protection of
the public health; (7) a certification (i.e.,
a signed statement by a responsible
official of the company) summarizing
the supporting evidence and providing
the rationale for the official’s
determination that the modification
does not increase the tobacco product’s
appeal to or use by minors, toxicity,
addictiveness, or abuse liability; (8)
other information justifying an
exemption; and (9) an environmental
assessment (EA) under part 25 (21 CFR
part 25) prepared in accordance with
the requirements of § 25.40.
The National Environmental Policy
Act of 1969 (NEPA) (42 U.S.C. 4321–
4347) states national environmental
objectives and imposes upon each
Federal Agency the duty to consider the
environmental effects of its actions.
Section 102(2)(C) of NEPA requires the
preparation of an environmental impact
statement for every major Federal action
that will significantly affect the quality
of the human environment.
The FDA NEPA regulations are
contained in part 25. All applications
for exemption from substantial
equivalence require the submission of
an EA. An EA provides information that
is used to determine whether an FDA
action could result in a significant
environmental impact. Section 25.40(a)
and (c) specifies the content
requirements for EAs for nonexcluded
actions.
The information required by
§ 1107.1(b) is submitted to FDA so FDA
can determine whether an exemption
from substantial equivalence to the
product is appropriate for the protection
of the public health. Section 1107.1(c)
states that FDA will review the
information submitted and determine
whether to grant or deny an exemption
based on whether the criteria in section
905(j)(3) of the FD&C Act are met. FDA
may request additional information if
necessary to make a determination and
may consider the exemption request
withdrawn if the information is not
provided within the requested
timeframe.
Section 905(j)(1)(A)(ii) of the FD&C
Act states that if an exemption has been
requested and granted, a report must be
submitted to FDA that demonstrates that
the tobacco product is modified within
the meaning of section 905(j)(3), the
modifications are to a product that is
commercially marketed and in
compliance with the requirements of the
FD&C Act, and all of the modifications
are covered by exemptions granted by
the Secretary of Health and Human
Services (the Secretary) under section
905(j)(3).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section and activity
Number of
responses per
respondent 2
Total annual
responses
Average
burden per
response
(in hours)
Total hours
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§ 1107.1(b) Optional Preparation of Tobacco Product Exemption From Substantial Equivalence Request Including § 25.40 Preparation of
an Environmental Assessment
21 CFR 1107.1(b)—Preparation of tobacco product exemption from substantial equivalence request and 21
CFR 25.40—Preparation of an environmental assessment ..................................................................................
812
1
812
24
19,488
Total Hours (§ 1107.1(b)) ..............................................
........................
........................
........................
........................
19,218
§ 1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial Equivalence Request
21 CFR 1107.1(c)—Preparation of additional information
for tobacco product exemption from substantial equivalence request ....................................................................
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732
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section and activity
Total Hours (§ 1107.1(c)) ..............................................
Number of
respondents
Number of
responses per
respondent 2
Total annual
responses
Average
burden per
response
(in hours)
........................
........................
........................
........................
Total hours
732
Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product is modified under section 905(j)(3), modifications are to a product that is commercially marketed and compliant, and modifications covered by exemptions granted by Secretary under section 905(j)(3)
Abbreviated report submitted to demonstrate tobacco
product is modified under section 905(j)(3), modifications are to a product that is commercially marketed and
compliant, and modifications covered by exemptions
granted by Secretary under section 905(j)(3) ..................
1217
1
1217
3
3,651
Total Hours (section 905(j)(1)(A)(ii)) of the FD&C Act
........................
........................
........................
........................
3,651
Total Hours Exemptions From Substantial Equivalence Requirements ..................................................
........................
........................
........................
........................
23,871
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that we will receive
812 exemption requests under
§ 1107.1(b) for 24 hours per response
including EA for a total of 19,488 hours.
Since an EA is required for each
§ 1107.1(b) (Optional Preparation of
Tobacco Product Exemption From
Substantial Equivalence Request), the
burden per response for EAs (12 hours)
has been combined with the 12 hours
for an SE request for a total of 24 hours
per response.
FDA further estimates that we will
receive 244 submissions requiring
additional information in support of the
initial exemption request, and it is
expected that it will take an average of
3 hours to prepare the additional
information for a total of 732 hours.
FDA estimates that 1,217 respondents
will prepare 1,217 responses and each
response will take approximately 3
hours to prepare, as required by section
905(j)(1)(A)(ii) of the FD&C Act, for a
total of 3,651 hours.
This collection of information
requires a manufacturer to submit a
report at least 90 days prior to making
an introduction or delivery for
introduction into interstate commerce
for commercial distribution of a tobacco
product. Section 905(j)(1)(A)(ii) of the
FD&C Act states that if an exemption
has been requested and granted, the
manufacturer must submit to FDA a
report that demonstrates that the
tobacco product is modified within the
meaning of section 905(j)(3), the
modifications are to a product that is
commercially marketed and in
compliance with the requirements of the
FD&C Act, and all the modifications are
covered by exemptions granted by the
Secretary under section 905(j)(3). FDA
estimates the total hours for exemptions
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from Substantial Equivalence
Requirements will be 23,871 hours.
FDA’s estimates are based on full
analysis of economic impacts and
information gathered from other FDAregulated products. Based on a review of
the currently approved information
collection, we have made no
adjustments to our burden estimate.
Dated: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19913 Filed 9–12–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Forms for Use With
Applications to the Maternal and Child
Health Bureau Research and Training
Grants, OMB No. 0906—New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
ACTION:
Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
SUMMARY:
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public regarding the burden estimate
below or any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than November 13,
2018.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Forms for Use with Applications to the
Maternal and Child Health Bureau
Research and Training Grants, OMB No.
0906–xxxx—New.
Abstract: HRSA currently utilizes the
National Institute of Health’s (NIH)
Biographical Sketch and Public Health
Service (PHS) Inclusion Enrollment
forms (0925–0001) for HRSA’s SF424
Research & Related application package
research grants. In order to update the
forms to meet HRSA’s needs, HRSA
plans to remove the NIH-specific
references and obtain its own OMB
control number for the collection of this
information.
Need and Proposed Use of the
Information: HRSA’s Maternal and
Child Health Bureau (MCHB) plans to
modify the Biographical Sketch and the
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[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46501-46504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19913]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1588]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Exemptions From Substantial Equivalence Requirements
for Tobacco Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 exemptions from substantial equivalence
requirements for tobacco products.
DATES: Submit either electronic or written comments on the collection
of information by November 13, 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 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 13, 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:
[[Page 46502]]
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-2013-N-1588 for ``Exemptions From Substantial Equivalence
Requirements 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 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.
Exemptions From Substantial Equivalence Requirements for Tobacco
Products
OMB Control Number 0910-0684--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 a chapter granting FDA important
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)).
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
[[Page 46503]]
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, May 10, 2016) (``the final deeming
rule'')).
FDA has established a pathway for manufacturers to request
exemptions from the substantial equivalence requirements of the FD&C
Act in Sec. [thinsp]1107.1 (21 CFR 1107.1) of the Agency's
regulations. As described in Sec. [thinsp]1107.1(a), FDA may exempt
tobacco products that are modified by adding or deleting a tobacco
additive, or increasing or decreasing the quantity of an existing
tobacco additive, from the requirement of demonstrating substantial
equivalence if the Agency determines that: (1) The modification would
be a minor modification of a tobacco product that can be sold under the
FD&C Act; (2) a report demonstrating substantial equivalence is not
necessary to ensure that permitting the tobacco product to be marketed
would be appropriate for the protection of public health; and (3) an
exemption is otherwise appropriate.
Section 1107.1(b) states that a request for exemption under section
905(j)(3) of the FD&C Act may be made only by the manufacturer of a
legally marketed tobacco product for a minor modification to that
tobacco product and that the manufacturer must submit the request and
all information supporting it to FDA. The request must be made in an
electronic format that FDA can process, review, and archive (or a
written request must be made by the manufacturer explaining in detail
why the manufacturer cannot submit the request in an electronic format
and requesting an alternative means of submission to the electronic
format).
An exemption request must contain: (1) The manufacturer's address
and contact information; (2) identification of the tobacco product(s);
(3) a detailed explanation of the purpose for the modification; (4) a
detailed description of the modification, including a statement as to
whether the modification involves adding or deleting a tobacco
additive, or increasing or decreasing the quantity of the existing
tobacco additive; (5) a detailed explanation of why the modification is
a minor modification of a tobacco product that can be sold under the
FD&C Act; (6) a detailed explanation of why a report under section
905(j)(1) of the FD&C Act intended to demonstrate substantial
equivalence is not necessary to ensure that permitting the tobacco
product to be marketed would be appropriate for protection of the
public health; (7) a certification (i.e., a signed statement by a
responsible official of the company) summarizing the supporting
evidence and providing the rationale for the official's determination
that the modification does not increase the tobacco product's appeal to
or use by minors, toxicity, addictiveness, or abuse liability; (8)
other information justifying an exemption; and (9) an environmental
assessment (EA) under part 25 (21 CFR part 25) prepared in accordance
with the requirements of Sec. [thinsp]25.40.
The National Environmental Policy Act of 1969 (NEPA) (42 U.S.C.
4321-4347) states national environmental objectives and imposes upon
each Federal Agency the duty to consider the environmental effects of
its actions. Section 102(2)(C) of NEPA requires the preparation of an
environmental impact statement for every major Federal action that will
significantly affect the quality of the human environment.
The FDA NEPA regulations are contained in part 25. All applications
for exemption from substantial equivalence require the submission of an
EA. An EA provides information that is used to determine whether an FDA
action could result in a significant environmental impact. Section
25.40(a) and (c) specifies the content requirements for EAs for
nonexcluded actions.
The information required by Sec. [thinsp]1107.1(b) is submitted to
FDA so FDA can determine whether an exemption from substantial
equivalence to the product is appropriate for the protection of the
public health. Section 1107.1(c) states that FDA will review the
information submitted and determine whether to grant or deny an
exemption based on whether the criteria in section 905(j)(3) of the
FD&C Act are met. FDA may request additional information if necessary
to make a determination and may consider the exemption request
withdrawn if the information is not provided within the requested
timeframe.
Section 905(j)(1)(A)(ii) of the FD&C Act states that if an
exemption has been requested and granted, a report must be submitted to
FDA that demonstrates that the tobacco product is modified within the
meaning of section 905(j)(3), the modifications are to a product that
is commercially marketed and in compliance with the requirements of the
FD&C Act, and all of the modifications are covered by exemptions
granted by the Secretary of Health and Human Services (the Secretary)
under section 905(j)(3).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section and activity Number of responses per Total annual per response Total hours
respondents respondent \2\ responses (in hours)
----------------------------------------------------------------------------------------------------------------
Sec. 1107.1(b) Optional Preparation of Tobacco Product Exemption From Substantial Equivalence Request
Including Sec. 25.40 Preparation of an Environmental Assessment
----------------------------------------------------------------------------------------------------------------
21 CFR 1107.1(b)--Preparation of 812 1 812 24 19,488
tobacco product exemption from
substantial equivalence request
and 21 CFR 25.40--Preparation
of an environmental assessment.
-------------------------------------------------------------------------------
Total Hours (Sec. .............. .............. .............. .............. 19,218
1107.1(b)).................
----------------------------------------------------------------------------------------------------------------
Sec. 1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial
Equivalence Request
----------------------------------------------------------------------------------------------------------------
21 CFR 1107.1(c)--Preparation of 244 1 244 3 732
additional information for
tobacco product exemption from
substantial equivalence request
-------------------------------------------------------------------------------
[[Page 46504]]
Total Hours (Sec. .............. .............. .............. .............. 732
1107.1(c)).................
----------------------------------------------------------------------------------------------------------------
Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product
is modified under section 905(j)(3), modifications are to a product that is commercially marketed and compliant,
and modifications covered by exemptions granted by Secretary under section 905(j)(3)
----------------------------------------------------------------------------------------------------------------
Abbreviated report submitted to 1217 1 1217 3 3,651
demonstrate tobacco product is
modified under section
905(j)(3), modifications are to
a product that is commercially
marketed and compliant, and
modifications covered by
exemptions granted by Secretary
under section 905(j)(3)........
-------------------------------------------------------------------------------
Total Hours (section .............. .............. .............. .............. 3,651
905(j)(1)(A)(ii)) of the
FD&C Act...................
-------------------------------------------------------------------------------
Total Hours Exemptions From .............. .............. .............. .............. 23,871
Substantial Equivalence
Requirements...............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that we will receive 812 exemption requests under
Sec. 1107.1(b) for 24 hours per response including EA for a total of
19,488 hours. Since an EA is required for each Sec. 1107.1(b)
(Optional Preparation of Tobacco Product Exemption From Substantial
Equivalence Request), the burden per response for EAs (12 hours) has
been combined with the 12 hours for an SE request for a total of 24
hours per response.
FDA further estimates that we will receive 244 submissions
requiring additional information in support of the initial exemption
request, and it is expected that it will take an average of 3 hours to
prepare the additional information for a total of 732 hours.
FDA estimates that 1,217 respondents will prepare 1,217 responses
and each response will take approximately 3 hours to prepare, as
required by section 905(j)(1)(A)(ii) of the FD&C Act, for a total of
3,651 hours.
This collection of information requires a manufacturer to submit a
report at least 90 days prior to making an introduction or delivery for
introduction into interstate commerce for commercial distribution of a
tobacco product. Section 905(j)(1)(A)(ii) of the FD&C Act states that
if an exemption has been requested and granted, the manufacturer must
submit to FDA a report that demonstrates that the tobacco product is
modified within the meaning of section 905(j)(3), the modifications are
to a product that is commercially marketed and in compliance with the
requirements of the FD&C Act, and all the modifications are covered by
exemptions granted by the Secretary under section 905(j)(3). FDA
estimates the total hours for exemptions from Substantial Equivalence
Requirements will be 23,871 hours.
FDA's estimates are based on full analysis of economic impacts and
information gathered from other FDA-regulated products. Based on a
review of the currently approved information collection, we have made
no adjustments to our burden estimate.
Dated: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19913 Filed 9-12-18; 8:45 am]
BILLING CODE 4164-01-P
