Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, 35875-35879 [2019-15791]
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35875
Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Notices
Fax written comments on the
collection of information by August 26,
2019.
DATES:
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 0910–0264. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
collection of information to OMB for
review and clearance.
Export of Medical Devices; Foreign
Letters of Approval
OMB Control Number 0910–0264—
Extension
Section 801(e)(2) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 381(e)(2)) provides for the
exportation of an unapproved device
under certain circumstances if the
exportation is not contrary to the public
health and safety and it has the approval
of the foreign country to which it is
intended for export. Requesters
communicate (either directly or through
a business associate in the foreign
country) with a representative of the
foreign government to which they seek
exportation, and written authorization
must be obtained from the appropriate
office within the foreign government
approving the importation of the
medical device. An alternative to
obtaining written authorization from the
foreign government is to accept a
notarized certification from a
responsible company official in the
United States that the product is not in
conflict with the foreign country’s laws.
This certification must include a
statement acknowledging that the
responsible company official making the
certification is subject to the provisions
of 18 U.S.C. 1001. This statutory
provision makes it a criminal offense to
knowingly and willingly make a false or
fraudulent statement, or make or use a
false document, in any manner within
the jurisdiction of a department or
Agency of the United States. The
respondents to this collection of
information are companies that seek to
export medical devices. FDA’s estimate
of the reporting burden is based on the
experience of FDA’s medical device
program personnel.
In the Federal Register of March 11,
2019 (84 FR 8727), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/FD&C Act section
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
Total
operating
and
maintenance
costs
Foreign letter of approval—801(e)(2) .............................................................
33
1
33
3
99
$8,250
1 There
are no capital costs associated with this collection of information.
We have adjusted our burden estimate
by decreasing the number of
respondents by 5, which has resulted in
a corresponding decrease of 15 hours to
the currently approved hour burden and
$1,250 to the total operating and
maintenance costs. This adjustment is
based on a decrease in the number of
submissions we received over the last
few years.
Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0305]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Deeming Tobacco
Products To Be Subject to the Federal
Food, Drug, and Cosmetic Act
AGENCY:
[FR Doc. 2019–15790 Filed 7–24–19; 8:45 am]
HHS.
BILLING CODE 4164–01–P
ACTION:
Food and Drug Administration,
Notice.
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.
DATES: Fax written comments on the
collection of information by August 26,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
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SUMMARY:
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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 0910–0768. 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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Notices
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Deeming Tobacco Products To Be
Subject to the Federal Food, Drug, and
Cosmetic Act
OMB Control Number 0910–0768—
Extension
The Tobacco Control Act, enacted on
June 22, 2009, amended the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) and provided FDA with the
authority to regulate tobacco products
(Pub. L. 111–31; 123 Stat. 1776).
Specifically, section 101(b) of the
Tobacco Control Act amended the FD&C
Act by adding chapter IX (21 U.S.C. 387
through 387u), which provides FDA
with tools to regulate tobacco products.
Section 901 of the FD&C Act (21 U.S.C.
387a) states that Chapter IX—Tobacco
Products applies to all cigarettes,
cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco and to any other
tobacco products that the Secretary of
Health and Human Services by
regulation deems to be subject to this
chapter.
The FD&C Act provides FDA
authority to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco,
smokeless tobacco, and any other
tobacco products that the Agency by
regulation deems to be subject to the
law. On May 10, 2016 (81 FR 28973)
FDA issued a final rule to deem
products meeting the statutory
definition of ‘‘tobacco product’’ to be
subject to the FD&C Act. This final rule
extended FDA’s ‘‘tobacco product’’
authorities under Chapter IX to all
tobacco products that meet the statutory
definition of ‘‘tobacco product’’ in
section 201(rr) of the FD&C Act (21
U.S.C. 321(rr)).
Section 910(a)(1) of the FD&C Act (21
U.S.C. 387j(a)(1)) defines a ‘‘new
tobacco product’’ as a tobacco product
that was not commercially marketed in
the United States on February 15, 2007,
or a modification (including a change in
design, any component, any part, or any
constituent, including a smoke
constituent, or in the content, delivery,
or form of nicotine, or any other
additive or ingredient) of a tobacco
product where the modified product
was commercially marketed in the
United States after February 15, 2007.
An order under section 910(c)(1)(A)(i) of
the FD&C Act is required prior to
marketing a new tobacco product. This
requirement applies unless the product
has been shown to be substantially
equivalent to a valid predicate product
or is exempt from substantial
equivalence.
Section 910(b) of the FD&C Act states
that a premarket tobacco application
(PMTA) shall contain full reports of all
investigations of health risks; a full
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statement of all components,
ingredients, additives, and properties,
and of the principle or principles of
operation of such tobacco product; a full
description of methods of
manufacturing and processing (which
includes a listing of all manufacturing,
packaging, and control sites for the
product); an explanation of how the
product complies with applicable
tobacco product standards; samples of
the product and its components; and
labeling.
FDA also encourages persons who
would like to study their new tobacco
product to meet with the Office of
Science in the Center for Tobacco
Products (CTP) to discuss their
investigational plan. The request for a
meeting should be sent in writing to the
Director of CTP’s Office of Science and
should include adequate information for
FDA to assess the potential utility of the
meeting and to identify FDA staff
necessary to discuss agenda items.
When the deeming final rule
published, FDA revised the following
information collections that added
deemed products to these collections:
Tobacco Product Establishment
Registration and Submission of Certain
Health Information (OMB control
number 0910–0650); Tobacco Health
Document Submission (OMB control
number 0910–0654); Exemptions from
Substantial Equivalence Requirements
(OMB control number 0910–0684);
Reports Intended to Demonstrate the
Substantial Equivalence of a New
Tobacco Product (OMB control number
0910–0673); Electronic Importer’s Entry
Notice (OMB control number 0910–
0046); Exports: Notification and
Recordkeeping Requirements (OMB
control number 0910–0482); and
Establishing That a Tobacco Product
Was Commercially Marketed in the
United States as of February 15, 2007
(OMB control number 0910–0775).
In the Federal Register of April 22,
2019 (84 FR 16673), FDA published a
60-day notice requesting public
comment on the extension of collection
of information ‘‘Deeming Tobacco
Products To Be Subject to the Federal
Food, Drug, and Cosmetic Act.’’ FDA
received one comment that was
Paperwork Reduction Act (PRA) related.
The commenter noted that they would
like to see the associated collections that
the deeming rule revised. FDA
appreciates the comment addressing the
associated deemed product information
collections. FDA notes that in the PRA
section of the deeming final rule (81 FR
28973 at 29076) all the revised OMB
information collection control numbers
and their revised burdens were all
listed. Per the comment, we have added
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a listing of all the collections the final
rule revised.
The commenter also notes that the
burdens associated with deemed
products are not all included in this
notice even though the notice ‘‘appears
intended to present a comprehensive set
of burden estimates and analyses for
information collection activities
associated with . . . the Deeming Rule.’’
FDA notes that this notice is not
intended to cover all information
collection reviews associated with the
deeming rule. Instead, this notice only
covers the information collections that
did not already have an approved
collection prior to the deeming final
rule. For the collections that existed
prior to the deeming final rule, FDA
added the new associated deemingrelated burdens to these previously
approved OMB control numbers. We
also note that some of the estimates
from the PRA section of the deeming
rule may have changed since the final
rule published. If any estimates have
changed, these changes have been
published in the Federal Register
through the process associated with
renewing PRA collections.
The comment also mentions the
omission of the burden associated with
the submission of harmful and
potentially harmful constituents (HPHC)
listings. FDA notes that we have not yet
sought OMB approval of the burden
associated with listing and reporting
HPHCs for deemed products. On March
8, 2019, FDA revised the ‘‘Extension of
Certain Tobacco Product Compliance
Deadlines Related to the Final Deeming
Rule’’ guidance (https://www.fda.gov/
media/105346/download) and the
related Small Entity Compliance Guide
entitled ‘‘FDA Deems Certain Tobacco
Products Subject to FDA Authority,
Sales and Distribution Restrictions, and
Health Warning Requirements for
Packages and Advertisements’’ (https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/fdadeems-certain-tobacco-products-subjectfda-authority-sales-and-distributionrestrictions-and). This revision extends
the HPHCs reporting compliance date to
a date that is 6 months after the
publication date of a final guidance
regarding HPHC reporting under section
904(a)(3) of the FD&C Act (21 U.S.C.
287d(a)(3)) and 9 months after that
publication date for small tobacco
product manufacturers. For products
entering the market after the publication
date of the final guidance,
manufacturers must submit their HPHC
report 90 days prior to marketing the
products under section 904(a)(3).
In the preamble to the final deeming
rule, FDA indicated that it intends to
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issue guidance regarding HPHC
reporting (and later a testing and
reporting regulation under section 915
of the FD&C Act (21 U.S.C. 387o)) with
enough time for manufacturers to report,
given the original 3-year compliance
period. At this time, FDA has not
published a final HPHC reporting
guidance and as a result, we are
providing a revised compliance date
based on when a final HPHC reporting
guidance is issued.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Obtaining an FDA Order Authorizing Marketing of Tobacco
Product (the application) and 21 CFR 25.40 Environmental Assessments:
Other Tobacco, E-Cigarettes, and Nicotine Product
Manufacturers (Electronic Nicotine Delivery Systems (ENDS) Liquids and Delivery Systems (Including Importers)) ...........................................................
Total annual
responses
Average
burden per
response
(in hours)
Total hours
200
3.75
750
1,713
1,284,750
........................
........................
........................
........................
1,284,750
200
1
200
4
800
Total Hours Request for Meeting with CTP’s Office of Science to Discuss Investigational Plan
........................
........................
........................
........................
800
Total Hours ‘‘Applications for Premarket Review of New Tobacco Products’’ ................
........................
........................
........................
........................
1,285,550
Total Hours Obtaining an FDA Order Authorizing
Marketing of Tobacco Product (the application)
Request for Meeting with CTP’s Office of Science to Discuss Investigational Plan:
Other Tobacco, E-Cigarettes, and Nicotine Product
Manufacturers (Electronic Nicotine Delivery Systems (ENDS) Liquids and Delivery Systems (Including Importers)) ...........................................................
1 There
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respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that it will take each
respondent approximately 1,500 hours
to prepare a PMTA seeking an order
from FDA allowing the marketing of a
new tobacco product. FDA also
estimates that it would on average take
an additional 213 hours to prepare an
environmental assessment in
accordance with the requirements of 21
CFR 25.40, for a total of 1,713 hours per
PMTA application. This average
represents a wide range of hours that
will be required for these applications
under different circumstances, with a
small number requiring more hours
(e.g., as many as 5,000 hours for early
applications that involve complex
products and for which the company
has no experience conducting studies or
preparing analysis of public health
impacts, or for which reliance on master
files is not possible) as well as many
requiring fewer hours (e.g., as few as 50
hours for applications for products that
are very similar to other new products).
A PMTA may require one or more types
of studies including chemical analysis,
nonclinical studies, and clinical studies.
FDA also estimates the number of
PMTAs that FDA expects to receive
annually will be 750 (642 ENDS Liquids
and 108 ENDS Delivery Systems).
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For tobacco products already on the
market at the time of the final rule,
much of the information required to
support a PMTA may be obtained from
previously published research on
similar products. Therefore, FDA
expects that a large portion of
applications may be reviewed with no
or minimal new nonclinical or clinical
studies being conducted to support an
application. In contrast, nonclinical and
clinical studies may be required for
market authorization of a new product
for which there is limited understanding
of its potential impact on the public
health. The range of hours involved to
compile these two types of applications
would be quite variable.
FDA anticipates that the 200 potential
respondents to this collection may need
to meet with CTP’s Office of Science to
discuss their investigational plans. To
request this meeting, applicants should
compile and submit information to FDA
for meeting approval. FDA estimates
that it will take approximately 4 hours
to compile this information, for a total
of 800 hours additional burden.
Therefore, the total annual burden for
submitting PMTA applications is
estimated to be 1,285,550 hours. FDA’s
estimates are based on the
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corresponding information collection
estimates and an assumption that
manufacturers would submit
applications for the premarket review of
tobacco products.
In § 1143.3(c) (21 CFR 1143.3(c)) an
exemption is provided to the
manufacturer of a product that
otherwise would be required to include
the warning statement in § 1143.3(a)(1)
on its packages and in its
advertisements, i.e., ‘‘WARNING: This
product contains nicotine. Nicotine is
an addictive chemical.’’ This warning is
required to appear on at least 30 percent
of the two principal display panels of
the package and on at least 20 percent
of the area of the advertisement.
To obtain an exemption from this
requirement, a manufacturer is required
to certify to FDA that its product does
not contain nicotine and that the
manufacturer has data to support that
assertion. For any product that obtains
this exemption, § 1143.3(c) requires that
the product bear the statement: ‘‘This
product is made from tobacco.’’ The
parties that package and label such
products will share responsibility for
ensuring that this alternative statement
is included on product packages and in
advertisements.
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TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
(in hours)
Total annual
responses
Total hours
Certification Statement .........................................................
5
1
5
20
100
Total Exemptions From the Required Warning Statement Requirement .....................................................
........................
........................
........................
........................
100
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated average burden per
response is based on currently approved
information collection estimates. The
estimated hours listed in the burden
table for certification submissions
reflect the time needed to test the
product for nicotine and to prepare and
submit the self-certification request.
FDA expects that these types of
certifications will be rare and estimates
that the Agency will receive on average
five submissions per year.
FDA concludes that the labeling
statements in §§ 1143.3(a)(1) and
1143.5(a)(1) and the alternative
statement in § 1143.3(c) (i.e., ‘‘This
product is made from tobacco’’) are not
subject to review by OMB because they
do not constitute a ‘‘collection of
information’’ under the PRA (44 U.S.C.
3501–3520). Rather, these labeling
statements are a ‘‘public disclosure’’ of
information originally supplied by the
Federal government to the recipient for
the purpose of ‘‘disclosure to the
public’’ (5 CFR 1320.3(c)(2)).
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Cigar warning plan
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Manufacturers, Importers, and Retailers .............................
10
1
10
120
1,200
Total Cigar Warning Plan .............................................
........................
........................
........................
........................
1,200
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The requirement for submission of
warning plans for cigar products, and
the specific requirements relating to the
random display and distribution of
required warning statements on cigar
packaging and quarterly rotation of
required warning statements in
alternating sequence on cigar product
advertising, appear in § 1143.5(c).
The six warnings for cigars (five
specifically for cigars and the one
addictiveness warning) are required to
be randomly displayed in each 12month period, in as equal a number of
times as is possible on each brand of
cigar sold in product packaging and be
randomly distributed in all areas of the
United States in which the product is
marketed in accordance with a warning
plan submitted to and approved by
FDA. For advertisements, the warning
statements must be rotated quarterly in
alternating sequence in each
advertisement for each brand of cigar in
accordance with a warning plan
submitted to and approved by FDA.
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FDA published a final guidance in
August 2018 (https://www.fda.gov/
downloads/TobaccoProducts/Labeling/
RulesRegulationsGuidance/
UCM534739.pdf) to assist
manufacturers, importers, distributors,
and retailers of cigars with the
submission of warning plans. FDA will
work with the submitters to ensure that
the plans submitted meet the
established criteria for approval under
21 CFR part 1143.
The warning statements on cigar
packaging must be randomly displayed
in each 12-month period, in as equal a
number of times as is possible on each
brand of cigar sold and are required to
be randomly distributed in all areas of
the United States in which the product
is marketed in accordance with a
warning plan submitted by the
responsible cigar manufacturer,
importer, distributor, or retailer to and
approved by FDA.
FDA also requires that the required
warning statements be rotated quarterly
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in alternating sequence in each
advertisement for each brand of cigar,
regardless of whether the cigar is sold in
product packaging. This rotation of
warning statements in cigar
advertisements also must be done in
accordance with a warning plan
submitted by the responsible cigar
manufacturer, importer, distributor, or
retailer to and approved by FDA.
The burden estimates are based on
FDA’s experience with cigar warning
plans, smokeless warning plans
associated information collection (OMB
control number 0910–0671), as well as
warning plans for cigarettes submitted
to the Federal Trade Commission prior
to the implementation of the Tobacco
Control Act on June 22, 2009.
We estimate 10 entities will submit
warning plans, and it will take an
average of 120 hours per respondent to
prepare and submit a warning plan for
packaging and advertising for a total of
1,200 hours.
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TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Small-Scale Manufacturer Reporting ...................................
75
1
75
2
150
Total Small-Scale Manufacturer Report .......................
........................
........................
........................
........................
150
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Generally, FDA considers a ‘‘smallscale tobacco product manufacturer’’ to
be a manufacturer of any regulated
tobacco product that employs 150 or
fewer full-time equivalent employees
and has annual total revenues of
$5,000,000 or less. FDA considers a
manufacturer to include each entity that
it controls, is controlled by, or is under
common control with such
manufacturer. To help make FDA’s
individual enforcement decisions more
efficient, a manufacturer may
voluntarily submit information
regarding employment and revenues.
FDA does not believe many
manufacturers who fit the criteria of a
small-scale tobacco product
manufacturer would submit the
voluntary information.
FDA estimates that there are
approximately 75 small-scale
manufacturers who will voluntarily
submit information. FDA believes it will
take respondents 2 hours to voluntarily
submit information regarding
employment and revenues for a total of
150 hours.
The total estimated burden for this
information collection is 1,286,950
reporting hours, and 1,040 annual
responses. Our estimated burden for the
information collection reflects an
overall decrease of 39,050 hours and a
corresponding decrease of 315
responses. We attribute this adjustment
to updated information in the number of
submissions we received over the last
few years.
Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15791 Filed 7–24–19; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2019–0349]
National Offshore Safety Advisory
Committee
U.S. Coast Guard, Department
of Homeland Security.
ACTION: Notice of Federal Advisory
Committee Meeting.
AGENCY:
The National Offshore Safety
Advisory Committee and its
Subcommittee will meet in Katy, Texas
to discuss Committee matters relating to
the safety of operations and other
matters affecting the offshore oil and gas
industry. All meetings will be open to
the public.
DATES:
Meetings: The National Offshore
Safety Advisory Committee and its
Subcommittee will meet on Tuesday,
September 10, 2019 and on Wednesday,
September 11, 2019. The Use of
Offshore Supply Vessels and Other NonPurpose Built Vessels for Restoration/
Recovery Activities Subcommittee will
meet on Tuesday, September 10, 2019
from 1 p.m. to 4 p.m. The full
Committee will meet on Wednesday,
September 11, 2019, from 8 a.m. to 6
p.m. (All times are Central Time). Please
note that these meetings may close early
if the Committee has completed its
business.
Comments and supporting
documentation: To ensure your
comments are received by Committee
members before the meetings, submit
your written comments no later than
August 27, 2019.
ADDRESSES: All meetings will be held at
DNV GL USA Facility, 1400 Ravello
Drive, Katy, Texas 77449.
For information on facilities or
services for individuals with disabilities
or to request special assistance at the
meetings, contact the individuals listed
in the FOR FURTHER INFORMATION
CONTACT section as soon as possible.
Instructions: You are free to submit
comments at any time, including orally
SUMMARY:
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at the meetings, but if you want
Committee members to review your
comment before the meetings, please
submit your comments no later than
August 27, 2019. We are particularly
interested in the comments in the
‘‘Agenda’’ section below. You must
include ‘‘Department of Homeland
Security’’ and docket number USCG–
2019–0349. Written comments may also
be submitted using the Federal
eRulemaking Portal at https://
www.regulations.gov. If you encounter
technical difficulties with comments
submission, contact the individual
listed in the FOR FURTHER INFORMATION
CONTACT section below. Comments
received will be posted without
alteration at https://www.regulations.gov,
including any personal information
provided. For more information about
the privacy and docket, review the
Privacy and Security Notice for the
Federal Docket Management System at
https://www.regulations.gov/
privacyNotice.
Docket Search: For access to the
docket to read documents or comments
related to this notice, go to https://
www.regulations.gov, and insert
‘‘USCG–2019–0349)’’ in the ‘‘Search’’
box, press Enter, and then click on the
item you wish to view.
FOR FURTHER INFORMATION CONTACT:
Commander Myles Greenway,
Designated Federal Officer of the
National Offshore Safety Advisory
Committee, Commandant (CG–OES–2),
U.S. Coast Guard, 2703 Martin Luther
King Jr. Avenue SE, Stop 7509,
Washington, DC 20593–7509; telephone
(202) 372–1410, fax (202) 372–8382 or
email: myles.j.greenway@uscg.mil, or
Mr. Patrick Clark, telephone (202) 372–
1358, fax (202) 372–8382 or email
patrick.w.clark@uscg.mil.
SUPPLEMENTARY INFORMATION: Notice of
this meeting is in compliance with the
Federal Advisory Committee Act, (Title
5 U.S.C. Appendix). The National
Offshore Safety Advisory Committee
provides advice and recommendations
to the Department of Homeland Security
on matters relating to activities directly
involved with or in support of the
exploration of offshore mineral and
E:\FR\FM\25JYN1.SGM
25JYN1
]]>Agencies
[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Notices]
[Pages 35875-35879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15791]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0305]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Deeming Tobacco
Products To Be Subject to the Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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.
DATES: Fax written comments on the collection of information by August
26, 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 [email protected]. All
comments should be identified with the OMB control number 0910-0768.
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,
[email protected].
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.
[[Page 35876]]
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and
Cosmetic Act
OMB Control Number 0910-0768--Extension
The Tobacco Control Act, enacted on June 22, 2009, amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and provided FDA with
the authority to regulate tobacco products (Pub. L. 111-31; 123 Stat.
1776). Specifically, section 101(b) of the Tobacco Control Act amended
the FD&C Act by adding chapter IX (21 U.S.C. 387 through 387u), which
provides FDA with tools to regulate tobacco products. Section 901 of
the FD&C Act (21 U.S.C. 387a) states that Chapter IX--Tobacco Products
applies to all cigarettes, cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco and to any other tobacco products that the
Secretary of Health and Human Services by regulation deems to be
subject to this chapter.
The FD&C Act provides FDA authority to regulate cigarettes,
cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any
other tobacco products that the Agency by regulation deems to be
subject to the law. On May 10, 2016 (81 FR 28973) FDA issued a final
rule to deem products meeting the statutory definition of ``tobacco
product'' to be subject to the FD&C Act. This final rule extended FDA's
``tobacco product'' authorities under Chapter IX to all tobacco
products that meet the statutory definition of ``tobacco product'' in
section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)).
Section 910(a)(1) of the FD&C Act (21 U.S.C. 387j(a)(1)) defines a
``new tobacco product'' as a tobacco product that was not commercially
marketed in the United States on February 15, 2007, or a modification
(including a change in design, any component, any part, or any
constituent, including a smoke constituent, or in the content,
delivery, or form of nicotine, or any other additive or ingredient) of
a tobacco product where the modified product was commercially marketed
in the United States after February 15, 2007. An order under section
910(c)(1)(A)(i) of the FD&C Act is required prior to marketing a new
tobacco product. This requirement applies unless the product has been
shown to be substantially equivalent to a valid predicate product or is
exempt from substantial equivalence.
Section 910(b) of the FD&C Act states that a premarket tobacco
application (PMTA) shall contain full reports of all investigations of
health risks; a full statement of all components, ingredients,
additives, and properties, and of the principle or principles of
operation of such tobacco product; a full description of methods of
manufacturing and processing (which includes a listing of all
manufacturing, packaging, and control sites for the product); an
explanation of how the product complies with applicable tobacco product
standards; samples of the product and its components; and labeling.
FDA also encourages persons who would like to study their new
tobacco product to meet with the Office of Science in the Center for
Tobacco Products (CTP) to discuss their investigational plan. The
request for a meeting should be sent in writing to the Director of
CTP's Office of Science and should include adequate information for FDA
to assess the potential utility of the meeting and to identify FDA
staff necessary to discuss agenda items.
When the deeming final rule published, FDA revised the following
information collections that added deemed products to these
collections: Tobacco Product Establishment Registration and Submission
of Certain Health Information (OMB control number 0910-0650); Tobacco
Health Document Submission (OMB control number 0910-0654); Exemptions
from Substantial Equivalence Requirements (OMB control number 0910-
0684); Reports Intended to Demonstrate the Substantial Equivalence of a
New Tobacco Product (OMB control number 0910-0673); Electronic
Importer's Entry Notice (OMB control number 0910-0046); Exports:
Notification and Recordkeeping Requirements (OMB control number 0910-
0482); and Establishing That a Tobacco Product Was Commercially
Marketed in the United States as of February 15, 2007 (OMB control
number 0910-0775).
In the Federal Register of April 22, 2019 (84 FR 16673), FDA
published a 60-day notice requesting public comment on the extension of
collection of information ``Deeming Tobacco Products To Be Subject to
the Federal Food, Drug, and Cosmetic Act.'' FDA received one comment
that was Paperwork Reduction Act (PRA) related.
The commenter noted that they would like to see the associated
collections that the deeming rule revised. FDA appreciates the comment
addressing the associated deemed product information collections. FDA
notes that in the PRA section of the deeming final rule (81 FR 28973 at
29076) all the revised OMB information collection control numbers and
their revised burdens were all listed. Per the comment, we have added a
listing of all the collections the final rule revised.
The commenter also notes that the burdens associated with deemed
products are not all included in this notice even though the notice
``appears intended to present a comprehensive set of burden estimates
and analyses for information collection activities associated with . .
. the Deeming Rule.'' FDA notes that this notice is not intended to
cover all information collection reviews associated with the deeming
rule. Instead, this notice only covers the information collections that
did not already have an approved collection prior to the deeming final
rule. For the collections that existed prior to the deeming final rule,
FDA added the new associated deeming-related burdens to these
previously approved OMB control numbers. We also note that some of the
estimates from the PRA section of the deeming rule may have changed
since the final rule published. If any estimates have changed, these
changes have been published in the Federal Register through the process
associated with renewing PRA collections.
The comment also mentions the omission of the burden associated
with the submission of harmful and potentially harmful constituents
(HPHC) listings. FDA notes that we have not yet sought OMB approval of
the burden associated with listing and reporting HPHCs for deemed
products. On March 8, 2019, FDA revised the ``Extension of Certain
Tobacco Product Compliance Deadlines Related to the Final Deeming
Rule'' guidance (https://www.fda.gov/media/105346/download) and the
related Small Entity Compliance Guide entitled ``FDA Deems Certain
Tobacco Products Subject to FDA Authority, Sales and Distribution
Restrictions, and Health Warning Requirements for Packages and
Advertisements'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-deems-certain-tobacco-products-subject-fda-authority-sales-and-distribution-restrictions-and). This revision
extends the HPHCs reporting compliance date to a date that is 6 months
after the publication date of a final guidance regarding HPHC reporting
under section 904(a)(3) of the FD&C Act (21 U.S.C. 287d(a)(3)) and 9
months after that publication date for small tobacco product
manufacturers. For products entering the market after the publication
date of the final guidance, manufacturers must submit their HPHC report
90 days prior to marketing the products under section 904(a)(3).
In the preamble to the final deeming rule, FDA indicated that it
intends to
[[Page 35877]]
issue guidance regarding HPHC reporting (and later a testing and
reporting regulation under section 915 of the FD&C Act (21 U.S.C.
387o)) with enough time for manufacturers to report, given the original
3-year compliance period. At this time, FDA has not published a final
HPHC reporting guidance and as a result, we are providing a revised
compliance date based on when a final HPHC reporting guidance is
issued.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
Activity respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Obtaining an FDA Order
Authorizing Marketing of
Tobacco Product (the
application) and 21 CFR 25.40
Environmental Assessments:
Other Tobacco, E-Cigarettes, 200 3.75 750 1,713 1,284,750
and Nicotine Product
Manufacturers (Electronic
Nicotine Delivery Systems
(ENDS) Liquids and Delivery
Systems (Including
Importers))................
-------------------------------------------------------------------------------
Total Hours Obtaining an .............. .............. .............. .............. 1,284,750
FDA Order Authorizing
Marketing of Tobacco
Product (the
application)...........
Request for Meeting with CTP's
Office of Science to Discuss
Investigational Plan:
Other Tobacco, E-Cigarettes, 200 1 200 4 800
and Nicotine Product
Manufacturers (Electronic
Nicotine Delivery Systems
(ENDS) Liquids and Delivery
Systems (Including
Importers))................
-------------------------------------------------------------------------------
Total Hours Request for .............. .............. .............. .............. 800
Meeting with CTP's
Office of Science to
Discuss Investigational
Plan...................
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Hours .............. .............. .............. .............. 1,285,550
``Applications for
Premarket Review of
New Tobacco
Products''.........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that it will take each respondent approximately 1,500
hours to prepare a PMTA seeking an order from FDA allowing the
marketing of a new tobacco product. FDA also estimates that it would on
average take an additional 213 hours to prepare an environmental
assessment in accordance with the requirements of 21 CFR 25.40, for a
total of 1,713 hours per PMTA application. This average represents a
wide range of hours that will be required for these applications under
different circumstances, with a small number requiring more hours
(e.g., as many as 5,000 hours for early applications that involve
complex products and for which the company has no experience conducting
studies or preparing analysis of public health impacts, or for which
reliance on master files is not possible) as well as many requiring
fewer hours (e.g., as few as 50 hours for applications for products
that are very similar to other new products). A PMTA may require one or
more types of studies including chemical analysis, nonclinical studies,
and clinical studies. FDA also estimates the number of PMTAs that FDA
expects to receive annually will be 750 (642 ENDS Liquids and 108 ENDS
Delivery Systems).
For tobacco products already on the market at the time of the final
rule, much of the information required to support a PMTA may be
obtained from previously published research on similar products.
Therefore, FDA expects that a large portion of applications may be
reviewed with no or minimal new nonclinical or clinical studies being
conducted to support an application. In contrast, nonclinical and
clinical studies may be required for market authorization of a new
product for which there is limited understanding of its potential
impact on the public health. The range of hours involved to compile
these two types of applications would be quite variable.
FDA anticipates that the 200 potential respondents to this
collection may need to meet with CTP's Office of Science to discuss
their investigational plans. To request this meeting, applicants should
compile and submit information to FDA for meeting approval. FDA
estimates that it will take approximately 4 hours to compile this
information, for a total of 800 hours additional burden.
Therefore, the total annual burden for submitting PMTA applications
is estimated to be 1,285,550 hours. FDA's estimates are based on the
corresponding information collection estimates and an assumption that
manufacturers would submit applications for the premarket review of
tobacco products.
In Sec. 1143.3(c) (21 CFR 1143.3(c)) an exemption is provided to
the manufacturer of a product that otherwise would be required to
include the warning statement in Sec. 1143.3(a)(1) on its packages and
in its advertisements, i.e., ``WARNING: This product contains nicotine.
Nicotine is an addictive chemical.'' This warning is required to appear
on at least 30 percent of the two principal display panels of the
package and on at least 20 percent of the area of the advertisement.
To obtain an exemption from this requirement, a manufacturer is
required to certify to FDA that its product does not contain nicotine
and that the manufacturer has data to support that assertion. For any
product that obtains this exemption, Sec. 1143.3(c) requires that the
product bear the statement: ``This product is made from tobacco.'' The
parties that package and label such products will share responsibility
for ensuring that this alternative statement is included on product
packages and in advertisements.
[[Page 35878]]
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
Activity respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Certification Statement......... 5 1 5 20 100
-------------------------------------------------------------------------------
Total Exemptions From the .............. .............. .............. .............. 100
Required Warning Statement
Requirement................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimated average burden per response is based on currently
approved information collection estimates. The estimated hours listed
in the burden table for certification submissions reflect the time
needed to test the product for nicotine and to prepare and submit the
self-certification request. FDA expects that these types of
certifications will be rare and estimates that the Agency will receive
on average five submissions per year.
FDA concludes that the labeling statements in Sec. Sec.
1143.3(a)(1) and 1143.5(a)(1) and the alternative statement in Sec.
1143.3(c) (i.e., ``This product is made from tobacco'') are not subject
to review by OMB because they do not constitute a ``collection of
information'' under the PRA (44 U.S.C. 3501-3520). Rather, these
labeling statements are a ``public disclosure'' of information
originally supplied by the Federal government to the recipient for the
purpose of ``disclosure to the public'' (5 CFR 1320.3(c)(2)).
Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
Cigar warning plan respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Manufacturers, Importers, and 10 1 10 120 1,200
Retailers......................
-------------------------------------------------------------------------------
Total Cigar Warning Plan.... .............. .............. .............. .............. 1,200
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The requirement for submission of warning plans for cigar products,
and the specific requirements relating to the random display and
distribution of required warning statements on cigar packaging and
quarterly rotation of required warning statements in alternating
sequence on cigar product advertising, appear in Sec. 1143.5(c).
The six warnings for cigars (five specifically for cigars and the
one addictiveness warning) are required to be randomly displayed in
each 12-month period, in as equal a number of times as is possible on
each brand of cigar sold in product packaging and be randomly
distributed in all areas of the United States in which the product is
marketed in accordance with a warning plan submitted to and approved by
FDA. For advertisements, the warning statements must be rotated
quarterly in alternating sequence in each advertisement for each brand
of cigar in accordance with a warning plan submitted to and approved by
FDA.
FDA published a final guidance in August 2018 (https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM534739.pdf) to assist manufacturers, importers, distributors, and
retailers of cigars with the submission of warning plans. FDA will work
with the submitters to ensure that the plans submitted meet the
established criteria for approval under 21 CFR part 1143.
The warning statements on cigar packaging must be randomly
displayed in each 12-month period, in as equal a number of times as is
possible on each brand of cigar sold and are required to be randomly
distributed in all areas of the United States in which the product is
marketed in accordance with a warning plan submitted by the responsible
cigar manufacturer, importer, distributor, or retailer to and approved
by FDA.
FDA also requires that the required warning statements be rotated
quarterly in alternating sequence in each advertisement for each brand
of cigar, regardless of whether the cigar is sold in product packaging.
This rotation of warning statements in cigar advertisements also must
be done in accordance with a warning plan submitted by the responsible
cigar manufacturer, importer, distributor, or retailer to and approved
by FDA.
The burden estimates are based on FDA's experience with cigar
warning plans, smokeless warning plans associated information
collection (OMB control number 0910-0671), as well as warning plans for
cigarettes submitted to the Federal Trade Commission prior to the
implementation of the Tobacco Control Act on June 22, 2009.
We estimate 10 entities will submit warning plans, and it will take
an average of 120 hours per respondent to prepare and submit a warning
plan for packaging and advertising for a total of 1,200 hours.
[[Page 35879]]
Table 4--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
Activity respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Small-Scale Manufacturer 75 1 75 2 150
Reporting......................
-------------------------------------------------------------------------------
Total Small-Scale .............. .............. .............. .............. 150
Manufacturer Report........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Generally, FDA considers a ``small-scale tobacco product
manufacturer'' to be a manufacturer of any regulated tobacco product
that employs 150 or fewer full-time equivalent employees and has annual
total revenues of $5,000,000 or less. FDA considers a manufacturer to
include each entity that it controls, is controlled by, or is under
common control with such manufacturer. To help make FDA's individual
enforcement decisions more efficient, a manufacturer may voluntarily
submit information regarding employment and revenues. FDA does not
believe many manufacturers who fit the criteria of a small-scale
tobacco product manufacturer would submit the voluntary information.
FDA estimates that there are approximately 75 small-scale
manufacturers who will voluntarily submit information. FDA believes it
will take respondents 2 hours to voluntarily submit information
regarding employment and revenues for a total of 150 hours.
The total estimated burden for this information collection is
1,286,950 reporting hours, and 1,040 annual responses. Our estimated
burden for the information collection reflects an overall decrease of
39,050 hours and a corresponding decrease of 315 responses. We
attribute this adjustment to updated information in the number of
submissions we received over the last few years.
Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15791 Filed 7-24-19; 8:45 am]
BILLING CODE 4164-01-P
