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, 744-747 [2019-00448]
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Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No. 0970–0198]
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: FY 2020–2022 Child Care and
Development Fund Plan for Tribes
(ACF–118A)
Description: The Child Care and
Development Fund (CCDF) Plan (the
Plan) for Tribes is required from each
CCDF Lead agency in accordance with
Section 658E of the Child Care and
Development Block Grant Act of 1990
(CCDBG Act), as amended, CCDBG Act
of 2014 (Pub. L. 113–186), and 42 U.S.C
9858. The Plan, submitted on the ACF–
118A, is required triennially, and
remains in effect for three years. The
Plan provides ACF and the public with
a description of, and assurance about
the States’ and Territories’ child care
programs. These Plans are the
applications for CCDF funds.
This Notice is required by the
Paperwork Reduction Act (PRA). The
PRA requires Federal agencies to
request approval from the Office of
Management and Budget (OMB) Office
of Information and Regulatory Affairs
(OIRA) for any information collection
that will ask the same question of ten or
more persons. The process includes
publication of an initial Federal
Register Notice (FRN) allowing 60 days
for public comments on the initial plan
for information collection, the
publication of a second FRN allowing
30 days for public comment on the final
proposed information collection, and
review and approval by the OMB Office
of Information and Regulatory Affairs.
The Office of Child Care (OCC) has
revised the FY 2020–2022 CCDF Plan
Preprint for Tribes to align with the
CCDF Final Rule published on
September 30, 2016. In making the
revisions, consideration was given to
minimize the burden of the collection of
information on respondents. The
revised document contains revisions to
improve the accuracy and clarity of
policy questions, definitions, and
guidance in order to improve the quality
of information that is collected.
Consistent with the statute and
regulations, ACF requests revisions of
the ACF–118A to align with the
requirements of the CCDF Final Rule.
Respondents: Tribal CCDF Lead
Agencies (260).
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
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ACF—118A Part I (for all tribes) .....................................................................
ACF—118A Part II (for medium and large allocation tribes only) ...................
Estimated Total Annual Burden
Hours: 20,457.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
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260
106
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–00386 Filed 1–30–19; 8:45 am]
BILLING CODE 4184–81–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 or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
SUMMARY:
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Number of
responses per
respondent
0.33
0.33
Average
burden
hours per
response
120
144
Total burden
hours
15,420
5,037
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
(HPHCs).
Submit either electronic or
written comments on the collection of
information by April 1, 2019.
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 1, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 1, 2019. 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.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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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 ‘‘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.
• 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
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the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
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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
(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
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
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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/
TobaccoProducts/GuidanceCompliance
RegulatoryInformation/ucm241339.htm.
The current established list of HPHCs
also is available on the internet at
https://www.fda.gov/downloads/
TobaccoProducts/Labeling/
RulesRegulationsGuidance/
UCM297828.pdf (77 FR 20034, April 3,
2012).
The purpose of the information
collection is to collect statutorily
mandated information regarding HPHCs
in 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, 3787b,
and 3787c 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 newly deemed
tobacco products. We intend to model
these forms on the current HPHC
reporting forms (i.e., Forms FDA 3787a,
3787b, and 3787c). A proposed
information collection for newly
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 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 ............................................................................
67
46
42
0.67
0.033
0.54
45
1.5
23
1.82
0.43
0.63
82
1
14
Total ..............................................................................
........................
........................
........................
........................
97
2. Testing of HPHC Quantities in Products
Cigarette Filler and RYO .....................................................
Smokeless ............................................................................
46
42
0.033
0.54
1.5
23
9.42
12.06
14
277
Total ..............................................................................
........................
........................
........................
........................
291
3. Testing of HPHC Quantities in Mainstream Smoke
Cigarette: ISO Regimen .......................................................
Cigarette: Health Canada Regimen .....................................
67
67
0.67
0.67
45
45
23.64
23.64
1,064
1,064
Total ..............................................................................
........................
........................
........................
........................
2,128
........................
........................
........................
........................
2,516
Total Section 904(c)(1) Reporting Burden Hours
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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 2,516
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 155
respondents (67 cigarette manufacturers
or importers, 46 RYO tobacco
manufacturers, 42 smokeless
manufacturers) will submit 97 HPHC
reports annually. This section addresses
the time required for manufacturers and
importers (or their agents), who must
report their product information to FDA
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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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, 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
for cigarettes, 0.43 hours for RYO, and
0.63 hours 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 estimated number of responses
under section 904(c)(1) is based on
FDA’s experience and the past 3 years’
actual responses to FDA under this
provision of the FD&C Act for statutorily
regulated products.
Section 2 of table 1 estimates that 88
respondents (46 cigarette filler and RYO
tobacco manufacturers and importers
and 42 smokeless manufacturers) will
test quantities of HPHCs in an average
of 24.5 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 291
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
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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 2,128 hours for this
section.
The total estimated burden for this
information collection is 2,516 hours
and 139 responses.
Our estimated burden for the
information collection reflects an
overall decrease of 2,125 hours and a
corresponding decrease of 142
responses. We attribute this decrease to
updated information on the number of
submissions we received over the last
few years.
Dated: January 11, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019–00448 Filed 1–30–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0070]
Microbiology Devices Panel Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing a
forthcoming public advisory committee
meeting of the Microbiology Devices
Panel. The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public.
DATES: The meeting will be held on
March 8, 2019, from 8 a.m. to 5 p.m.
ADDRESSES: Hilton Washington, DC
North/Gaithersburg, Salons A, B, C and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s phone number is
301–977–8900; additional information
available online at: https://
www3.hilton.com/en/hotels/maryland/
hilton-washington-dc-northgaithersburg-GAIGHHF/.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
SUMMARY:
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AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Aden Asefa, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G642, Silver Spring,
MD 20993–0002, Aden.Asefa@
fda.hhs.gov, 301–796–0400, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On March 8, 2019, the
committee will discuss and make
recommendations regarding new or
alternative approaches to the clinical
study design and evaluation of devices
detecting Human Papillomavirus (HPV)
nucleic acid. These approaches will take
into consideration scientific data
generated since the approval of the first
High Risk (HR) HPV screening device in
2003 as well as the effects of HPV
vaccination on clinical studies of
devices for HPV detection. Topics to be
addressed at the meeting include
clinical study design and comparator
methods. Additionally, the committee
will discuss potential changes to the HR
HPV device indications for use
considering continually evolving
cervical cancer screening guidelines.
The committee will provide expert
feedback regarding the benefits and
risks from the adoption of changes in
each of the above topics and make
recommendations for future HR HPV
device evaluation strategies that are
both scientifically rigorous and least
burdensome.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
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]]>Agencies
[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 744-747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00448]
-----------------------------------------------------------------------
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on reporting harmful and potentially harmful
constituents (HPHCs).
DATES: Submit either electronic or written comments on the collection
of information by April 1, 2019.
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 1, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 1, 2019. 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
[[Page 745]]
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 ``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.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 (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 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
[[Page 746]]
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm. The current
established list of HPHCs also is available on the internet at https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM297828.pdf (77 FR 20034, April 3, 2012).
The purpose of the information collection is to collect statutorily
mandated information regarding HPHCs in 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,
3787b, and 3787c 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 newly deemed tobacco products.
We intend to model these forms on the current HPHC reporting forms
(i.e., Forms FDA 3787a, 3787b, and 3787c). A proposed information
collection for newly 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 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....................... 67 0.67 45 1.82 82
RYO............................. 46 0.033 1.5 0.43 1
Smokeless....................... 42 0.54 23 0.63 14
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................... .............. .............. .............. .............. 97
----------------------------------------------------------------------------------------------------------------
2. Testing of HPHC Quantities in Products
----------------------------------------------------------------------------------------------------------------
Cigarette Filler and RYO........ 46 0.033 1.5 9.42 14
Smokeless....................... 42 0.54 23 12.06 277
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................... .............. .............. .............. .............. 291
----------------------------------------------------------------------------------------------------------------
3. Testing of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
Cigarette: ISO Regimen.......... 67 0.67 45 23.64 1,064
Cigarette: Health Canada Regimen 67 0.67 45 23.64 1,064
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................... .............. .............. .............. .............. 2,128
-------------------------------------------------------------------------------
Total Section 904(c)(1) .............. .............. .............. .............. 2,516
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
2,516 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 155 respondents (67 cigarette
manufacturers or importers, 46 RYO tobacco manufacturers, 42 smokeless
manufacturers) will submit 97 HPHC reports annually. This section
addresses the time required for manufacturers and importers (or their
agents), who must report their product information to FDA
[[Page 747]]
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, 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 for cigarettes, 0.43 hours for
RYO, and 0.63 hours 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 estimated number of responses under section 904(c)(1) is based
on FDA's experience and the past 3 years' actual responses to FDA under
this provision of the FD&C Act for statutorily regulated products.
Section 2 of table 1 estimates that 88 respondents (46 cigarette
filler and RYO tobacco manufacturers and importers and 42 smokeless
manufacturers) will test quantities of HPHCs in an average of 24.5
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 291 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 2,128 hours for this section.
The total estimated burden for this information collection is 2,516
hours and 139 responses.
Our estimated burden for the information collection reflects an
overall decrease of 2,125 hours and a corresponding decrease of 142
responses. We attribute this decrease to updated information on the
number of submissions we received over the last few years.
Dated: January 11, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00448 Filed 1-30-19; 8:45 am]
BILLING CODE 4164-01-P
