Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act, 6869-6872 [2022-02478]
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Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices
provided must be placed in the political
file. These records must be placed in the
political file as soon as possible and
retained for a period of two years.
All other information collection
requirements contained under 47 CFR
25.701 and 25.702 are still a part of the
information collection and remain
unchanged since last approved by OMB.
This information collection (OMB
3060–1207) also consolidates the
information collections in OMB 3060–
1065, OMB 3060–1212, and the portion
of OMB 3060–0214 which related to
SDARS licensees to eliminate
duplication and inconsistencies
between these information collections.
OMB 3060–1065 and OMB 3060–1212
will be discontinued.
Federal Communications Commission.
Katura Jackson,
Federal Register Liaison Officer.
[FR Doc. 2022–02497 Filed 2–4–22; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for public comment.
The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR) is
requesting an extension of the ORR–6
Performance Report (OMB #0970–0036,
expiration 2/28/2022) until 8/31/2022.
ORR published a notice in the Federal
Register on 8/12/2021 requesting
comments within 60-days on revisions
to the ORR–6. A related revision request
will be submitted to the Office of
Management and Budget along with an
additional 30-day comment period prior
to 8/12/2022.
SUMMARY:
Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing infocollection@
ADDRESSES:
Administration for Children and
Families
Submission for OMB Review; ORR–6
Performance Report (OMB #0970–
0036)
Office of Refugee Resettlement,
Administration for Children and
Families, HHS.
AGENCY:
ACTION:
acf.hhs.gov. Identify all requests by the
title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: ACF/ORR requests
information from the ORR–6
Performance Report to determine
effectiveness of state Cash and Medical
Assistance (CMA) and Refugee Support
Services programs. ORR uses state-bystate CMA utilization rates, derived
from the ORR–6 Performance Report, to
formulate program initiatives, priorities,
standards, budget requests, and
assistance policies. Federal regulations
require state Refugee Resettlement,
Replacement Designee agencies, and
local governments submit statistical or
programmatic information that the ORR
Director determines to be required to
fulfill their responsibility under the
Immigration and Nationality Act (INA).
ORR will submit a revision request prior
to 8/12/2022 for the revisions described
in 86 FR 44370 (https://www.federal
register.gov/d/2021-17246). An
additional request for comments will
publish in the Federal Register at the
time of the revision request.
Respondents: State governments and
Replacement Designees.
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Total number
of responses
per respondent
Average
burden hours
per response
Total burden
hours
Annual burden
hours
ORR–6 Performance Report .............................................
64
6
15
5,760
1,920
Estimated Total Annual Burden
Hours: 1,920.
Authority: 8 U.S.C 1522 of the
Immigration and Nationality Act (the
Act) (title IV, sec. 412 of the Act), and
45 CFR 400.28(b).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–02438 Filed 2–4–22; 8:45 am]
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BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0049]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Reporting Harmful
and Potentially Harmful Constituents
in Tobacco Products and Tobacco
Smoke Under the Federal Food, Drug,
and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
SUMMARY:
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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 Reporting Harmful
and Potentially Harmful Constituents in
Tobacco Products and Tobacco Smoke
Under the Federal Food, Drug, and
Cosmetic Act.
Submit either electronic or
written comments on the collection of
information by April 8, 2022.
DATES:
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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 April 8, 2022.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 8, 2022. 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.
ADDRESSES:
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–D–0049 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Reporting
Harmful and Potentially Harmful
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Constituents in Tobacco Products and
Tobacco Smoke Under the Federal
Food, Drug, and Cosmetic Act.’’
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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
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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.
Reporting Harmful and Potentially
Harmful Constituents in Tobacco
Products and Tobacco Smoke Under
the Federal Food, Drug, and Cosmetic
Act
OMB Control Number 0910–0732—
Extension
The Family Smoking Prevention and
Tobacco Control Act (Pub. L. 111–31)
(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 the manufacture, marketing,
and distribution of cigarettes, cigarette
tobacco, roll-your-own (RYO) tobacco,
and smokeless tobacco products to
protect the public health and to reduce
tobacco use by minors. The Tobacco
Control Act also gave FDA the authority
to issue regulations deeming other
products that meet the statutory
definition of a tobacco product to be
subject to chapter IX of the FD&C Act
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(section 901(b) of the FD&C Act (21
U.S.C. 387a(b))).
In accordance with that authority, on
May 10, 2016, FDA issued a final rule
deeming all products that meet the
statutory definition of tobacco product,
except accessories of newly deemed
tobacco products, to be subject to FDA’s
tobacco product authority (final
deeming rule) (81 FR 28974).
Chapter IX of the FD&C Act now
applies to newly regulated products,
including sections 904(a)(3) and (c)(1)
(21 U.S.C. 387d(a)(3) and (c)(1)). Section
904(a)(3) of the FD&C Act requires the
submission of an initial report from
each tobacco product manufacturer or
importer, or agents thereof, listing all
constituents, including smoke
constituents as applicable, identified as
a harmful and potentially harmful
constituent (HPHC) to health by FDA.
Reports must be by brand and by
quantity in each brand and subbrand.
We note that for cigarettes, smokeless
tobacco, cigarette filler, and RYO
tobacco products, this initial reporting
was completed in 2012.
Section 904(c)(1) of the FD&C Act
provides that manufacturers of tobacco
products not on the market as of June
22, 2009, must also provide the
information reportable under section
904(a)(3) at least 90 days prior to
introducing the product into interstate
commerce.1
FDA has taken several steps to
identify HPHCs to be reported under
section 904 of the FD&C Act, including
issuing a guidance discussing FDA’s
current thinking on the meaning of the
term ‘‘harmful and potentially harmful
constituent’’ in the context of
implementing the HPHC list
requirement under section 904(e) of the
FD&C Act (76 FR 5387, January 31,
2011, revised guidance issued August
2016). The guidance is available on the
internet at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/harmful-andpotentially-harmful-constituentstobacco-products-used-section-904efederal-food-drug. The current
established list of HPHCs also is
available on the internet at https://
www.fda.gov/tobacco-products/rulesregulations-and-guidance/harmful-andpotentially-harmful-constituentstobacco-products-and-tobacco-smokeestablished-list (77 FR 20034, April 3,
2012).
The purpose of the information
collection is to collect statutorily
mandated information regarding HPHCs
in certain tobacco products and tobacco
smoke, by brand and by quantity in each
brand and subbrand.
To facilitate the submission of HPHC
information, Forms FDA 3787a–j, for
cigarettes, smokeless tobacco products,
and RYO tobacco products, respectively,
in both paper and electronic formats, are
available. Additionally, FDA is
developing forms to facilitate the
submission of HPHC information for the
deemed tobacco products. We intend to
model these forms on the current HPHC
reporting forms (i.e., Forms FDA 3787a–
j). A proposed information collection for
deemed products will be published in a
separate Federal Register notice, and we
will solicit comments on that collection
at that time.
Manufacturers or importers, or their
agents, may submit HPHC information
either electronically or in paper format.
The FDA eSubmitter tool, available at
https://www.fda.gov/industry/fdaesubmitter/using-esubmitter-preparetobacco-product-submissions, provides
electronic forms to streamline the data
entry and submission process for
reporting HPHCs for cigarettes,
smokeless tobacco products, and RYO
tobacco products. Users of eSubmitter
may populate an FDA-created Excel file
and import data into eSubmitter.
Whether respondents decide to submit
reports electronically or on paper, each
form provides instructions for
completing and submitting HPHC
information to FDA. The forms contain
fields for company information, product
information, and HPHC information.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Reporting for Section 904(c)(1) Products
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
Cigarette ...............................................................................
RYO .....................................................................................
Smokeless ............................................................................
380
19
25
1
1
1
380
19
25
1.82
0.43
0.63
692
8
16
Total ..............................................................................
........................
........................
........................
........................
716
2. Testing of HPHC Quantities in Products
Cigarette Filler and RYO .....................................................
Smokeless ............................................................................
19
25
1
1
19
25
9.42
12.06
179
302
Total ..............................................................................
........................
........................
........................
........................
481
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3. Testing of HPHC Quantities in Mainstream Smoke
Cigarette: ISO Regimen .......................................................
Cigarette: Health Canada Regimen .....................................
380
380
1
1
380
380
23.64
23.64
8,983
8,983
Total ..............................................................................
........................
........................
........................
........................
17,996
1 Note that section 904(c)(1) testing and reporting
requirements are separate from the requirements
that must be satisfied before a new tobacco product
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(sections 905 and 910 of the FD&C Act (21 U.S.C.
387e and 387j)), or modified risk tobacco product
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(section 911 of the FD&C Act (21 U.S.C. 387k)) may
be marketed.
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity
Total Section 904(c)(1) Reporting Burden Hours
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1 There
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
Total hours
19,193
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden for this collection of
information is estimated to be 19,193
hours. The burden estimate for this
collection of information includes the
time it will take to read the instructions,
test the products, and prepare the HPHC
report. In arriving at this burden
estimate, FDA estimated the number of
tobacco products to be reported under
the requirements of section 904(c)(1) of
the FD&C Act annually to FDA.
Section 1 of table 1 estimates that 424
respondents (380 cigarettes receiving
authorizations, 19 RYO tobacco
receiving authorizations, 25 smokeless
receiving authorizations) will submit
424 HPHC reports annually. Each
respondent represents a statutory
tobacco product that receives
authorization from FDA for which
manufacturers and importers (or their
agents), must report their product
information to FDA under section
904(c)(1) of the FD&C Act at least 90
days prior to delivery for introduction
into interstate commerce for all new
products. This section addresses the
time required to report their company
information to FDA through the use of
the electronic portal or paper forms.
The company information reported
includes company name; mailing
address; telephone and Fax numbers;
FDA Establishment Identifier number;
Data Universal Numbering System
number; and point of contact name,
mailing address, and telephone and Fax
numbers, as applicable. It also addresses
the time required for manufacturers and
importers to report their product
information by entering certain testing
information into the electronic or paper
forms.
The product information includes
brand and subbrand name; unique
product identification number; type of
product identification number; product
category and subcategory; and mean
weight and standard deviation of
tobacco in product.
We estimate that the burden to enter
both the company and product
information is no more than 1.82 hours
per response for cigarettes, 0.43 hours
per response for RYO, and 0.63 hours
per response for smokeless tobacco
products regardless of whether the
paper or electronic Form FDA series
3787 is used. The time to report per
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tobacco product types varies because
the number of HPHCs varies by tobacco
product category. The total hours
estimated for this section is 716.
The estimated number of responses
under section 904(c)(1) of the FD&C Act
is based on FDA’s experience, the past
4 years of tobacco products receiving
marketing authorizations from FDA, and
actual responses to FDA under this
provision of the FD&C Act for statutorily
regulated products.
Section 2 of table 1 estimates that 44
respondents (19 cigarette filler and RYO
tobacco receiving authorizations and 25
smokeless receiving authorizations) will
test quantities of HPHCs in an average
of 44 products annually. This section
addresses the time required for
manufacturers and importers (or their
agents) who must test HPHC quantities
in products. The burden estimates
include the burden to test the tobacco
products, draft testing reports, and
submit the report to FDA. The total
expected burden for this section is 481
hours.
Section 3 of table 1 addresses the time
required for manufacturers and
importers to test quantities for HPHCs in
cigarette smoke. The burden estimates
include: The burden to test the number
of replicate measurements; test date
range; manufacture date range;
extraction method; separation method;
detection method; and mean quantity
and standard deviation of HPHCs and
includes the burden to test the tobacco
products, draft testing reports, and
submit the report to FDA. The annual
burden reflects our estimate of the time
it takes to test the tobacco products (i.e.,
carry out laboratory work). The burden
estimate assumes that manufacturers
and importers report HPHC quantities in
cigarette mainstream smoke according
to the two smoking regimens. The total
expected burden is 17,996 hours for this
section.
The total estimated burden for this
information collection is 19,193 hours
and 424 respondents. Our estimated
burden for the information collection
reflects an overall increase of 269
respondents and a corresponding
increase of 16,677 hours. We attribute
this adjustment to updated methodology
in which the current estimates are
derived from historical statutory tobacco
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product applications submitted and
authorized by FDA in the past 4 years
as (1) manufacturers and importers (or
their agents) of authorized products are
required to submit HPHC reports at least
90 days prior to delivery for
introduction into interstate commerce
for all new products and (2) initial
reporting under section 904(a)(3) of the
FD&C Act for statutory products was
completed in 2012.
Dated: February 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02478 Filed 2–4–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0961]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Environmental
Impact Considerations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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: Submit written comments
(including recommendations) on the
collection of information by March 9,
2022.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0322. Also include
the FDA docket number found in
ADDRESSES:
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]]>Agencies
[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Notices]
[Pages 6869-6872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02478]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0049]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Reporting Harmful and Potentially Harmful Constituents
in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and
Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 Reporting Harmful and
Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
Under the Federal Food, Drug, and Cosmetic Act.
DATES: Submit either electronic or written comments on the collection
of information by April 8, 2022.
[[Page 6870]]
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 April 8, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 8, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-D-0049 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Reporting Harmful and Potentially
Harmful Constituents in Tobacco Products and Tobacco Smoke Under the
Federal Food, Drug, and Cosmetic Act.'' 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
Reporting Harmful and Potentially Harmful Constituents in Tobacco
Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic
Act
OMB Control Number 0910-0732--Extension
The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (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 the manufacture, marketing, and distribution
of cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and
smokeless tobacco products to protect the public health and to reduce
tobacco use by minors. The Tobacco Control Act also gave FDA the
authority to issue regulations deeming other products that meet the
statutory definition of a tobacco product to be subject to chapter IX
of the FD&C Act
[[Page 6871]]
(section 901(b) of the FD&C Act (21 U.S.C. 387a(b))).
In accordance with that authority, on May 10, 2016, FDA issued a
final rule deeming all products that meet the statutory definition of
tobacco product, except accessories of newly deemed tobacco products,
to be subject to FDA's tobacco product authority (final deeming rule)
(81 FR 28974).
Chapter IX of the FD&C Act now applies to newly regulated products,
including sections 904(a)(3) and (c)(1) (21 U.S.C. 387d(a)(3) and
(c)(1)). Section 904(a)(3) of the FD&C Act requires the submission of
an initial report from each tobacco product manufacturer or importer,
or agents thereof, listing all constituents, including smoke
constituents as applicable, identified as a harmful and potentially
harmful constituent (HPHC) to health by FDA. Reports must be by brand
and by quantity in each brand and subbrand. We note that for
cigarettes, smokeless tobacco, cigarette filler, and RYO tobacco
products, this initial reporting was completed in 2012.
Section 904(c)(1) of the FD&C Act provides that manufacturers of
tobacco products not on the market as of June 22, 2009, must also
provide the information reportable under section 904(a)(3) at least 90
days prior to introducing the product into interstate commerce.\1\
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\1\ Note that section 904(c)(1) testing and reporting
requirements are separate from the requirements that must be
satisfied before a new tobacco product (sections 905 and 910 of the
FD&C Act (21 U.S.C. 387e and 387j)), or modified risk tobacco
product (section 911 of the FD&C Act (21 U.S.C. 387k)) may be
marketed.
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FDA has taken several steps to identify HPHCs to be reported under
section 904 of the FD&C Act, including issuing a guidance discussing
FDA's current thinking on the meaning of the term ``harmful and
potentially harmful constituent'' in the context of implementing the
HPHC list requirement under section 904(e) of the FD&C Act (76 FR 5387,
January 31, 2011, revised guidance issued August 2016). The guidance is
available on the internet at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/harmful-and-potentially-harmful-constituents-tobacco-products-used-section-904e-federal-food-drug. The current established list of HPHCs also is available on the
internet at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list (77 FR 20034, April 3, 2012).
The purpose of the information collection is to collect statutorily
mandated information regarding HPHCs in certain tobacco products and
tobacco smoke, by brand and by quantity in each brand and subbrand.
To facilitate the submission of HPHC information, Forms FDA 3787a-
j, for cigarettes, smokeless tobacco products, and RYO tobacco
products, respectively, in both paper and electronic formats, are
available. Additionally, FDA is developing forms to facilitate the
submission of HPHC information for the deemed tobacco products. We
intend to model these forms on the current HPHC reporting forms (i.e.,
Forms FDA 3787a-j). A proposed information collection for deemed
products will be published in a separate Federal Register notice, and
we will solicit comments on that collection at that time.
Manufacturers or importers, or their agents, may submit HPHC
information either electronically or in paper format. The FDA
eSubmitter tool, available at https://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions,
provides electronic forms to streamline the data entry and submission
process for reporting HPHCs for cigarettes, smokeless tobacco products,
and RYO tobacco products. Users of eSubmitter may populate an FDA-
created Excel file and import data into eSubmitter. Whether respondents
decide to submit reports electronically or on paper, each form provides
instructions for completing and submitting HPHC information to FDA. The
forms contain fields for company information, product information, and
HPHC information.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Reporting for Section 904(c)(1) Products
----------------------------------------------------------------------------------------------------------------
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
----------------------------------------------------------------------------------------------------------------
Cigarette....................... 380 1 380 1.82 692
RYO............................. 19 1 19 0.43 8
Smokeless....................... 25 1 25 0.63 16
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Total....................... .............. .............. .............. .............. 716
----------------------------------------------------------------------------------------------------------------
2. Testing of HPHC Quantities in Products
----------------------------------------------------------------------------------------------------------------
Cigarette Filler and RYO........ 19 1 19 9.42 179
Smokeless....................... 25 1 25 12.06 302
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Total....................... .............. .............. .............. .............. 481
----------------------------------------------------------------------------------------------------------------
3. Testing of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
Cigarette: ISO Regimen.......... 380 1 380 23.64 8,983
Cigarette: Health Canada Regimen 380 1 380 23.64 8,983
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 17,996
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[[Page 6872]]
Total Section 904(c)(1) .............. .............. .............. .............. 19,193
Reporting Burden Hours.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden for this collection of information is estimated to be
19,193 hours. The burden estimate for this collection of information
includes the time it will take to read the instructions, test the
products, and prepare the HPHC report. In arriving at this burden
estimate, FDA estimated the number of tobacco products to be reported
under the requirements of section 904(c)(1) of the FD&C Act annually to
FDA.
Section 1 of table 1 estimates that 424 respondents (380 cigarettes
receiving authorizations, 19 RYO tobacco receiving authorizations, 25
smokeless receiving authorizations) will submit 424 HPHC reports
annually. Each respondent represents a statutory tobacco product that
receives authorization from FDA for which manufacturers and importers
(or their agents), must report their product information to FDA under
section 904(c)(1) of the FD&C Act at least 90 days prior to delivery
for introduction into interstate commerce for all new products. This
section addresses the time required to report their company information
to FDA through the use of the electronic portal or paper forms.
The company information reported includes company name; mailing
address; telephone and Fax numbers; FDA Establishment Identifier
number; Data Universal Numbering System number; and point of contact
name, mailing address, and telephone and Fax numbers, as applicable. It
also addresses the time required for manufacturers and importers to
report their product information by entering certain testing
information into the electronic or paper forms.
The product information includes brand and subbrand name; unique
product identification number; type of product identification number;
product category and subcategory; and mean weight and standard
deviation of tobacco in product.
We estimate that the burden to enter both the company and product
information is no more than 1.82 hours per response for cigarettes,
0.43 hours per response for RYO, and 0.63 hours per response for
smokeless tobacco products regardless of whether the paper or
electronic Form FDA series 3787 is used. The time to report per tobacco
product types varies because the number of HPHCs varies by tobacco
product category. The total hours estimated for this section is 716.
The estimated number of responses under section 904(c)(1) of the
FD&C Act is based on FDA's experience, the past 4 years of tobacco
products receiving marketing authorizations from FDA, and actual
responses to FDA under this provision of the FD&C Act for statutorily
regulated products.
Section 2 of table 1 estimates that 44 respondents (19 cigarette
filler and RYO tobacco receiving authorizations and 25 smokeless
receiving authorizations) will test quantities of HPHCs in an average
of 44 products annually. This section addresses the time required for
manufacturers and importers (or their agents) who must test HPHC
quantities in products. The burden estimates include the burden to test
the tobacco products, draft testing reports, and submit the report to
FDA. The total expected burden for this section is 481 hours.
Section 3 of table 1 addresses the time required for manufacturers
and importers to test quantities for HPHCs in cigarette smoke. The
burden estimates include: The burden to test the number of replicate
measurements; test date range; manufacture date range; extraction
method; separation method; detection method; and mean quantity and
standard deviation of HPHCs and includes the burden to test the tobacco
products, draft testing reports, and submit the report to FDA. The
annual burden reflects our estimate of the time it takes to test the
tobacco products (i.e., carry out laboratory work). The burden estimate
assumes that manufacturers and importers report HPHC quantities in
cigarette mainstream smoke according to the two smoking regimens. The
total expected burden is 17,996 hours for this section.
The total estimated burden for this information collection is
19,193 hours and 424 respondents. Our estimated burden for the
information collection reflects an overall increase of 269 respondents
and a corresponding increase of 16,677 hours. We attribute this
adjustment to updated methodology in which the current estimates are
derived from historical statutory tobacco product applications
submitted and authorized by FDA in the past 4 years as (1)
manufacturers and importers (or their agents) of authorized products
are required to submit HPHC reports at least 90 days prior to delivery
for introduction into interstate commerce for all new products and (2)
initial reporting under section 904(a)(3) of the FD&C Act for statutory
products was completed in 2012.
Dated: February 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02478 Filed 2-4-22; 8:45 am]
BILLING CODE 4164-01-P
