Notice2022-03994
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 25, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 the information collection associated with the tobacco health document submission.
Full Text
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<title>Federal Register, Volume 87 Issue 38 (Friday, February 25, 2022)</title>
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[Federal Register Volume 87, Number 38 (Friday, February 25, 2022)]
[Notices]
[Pages 10800-10803]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0377]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Tobacco Health Document Submission
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 the information collection associated with
the tobacco health document submission.
DATES: Submit either electronic or written comments on the collection
of information by April 26, 2022.
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 26, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 26, 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are
[[Page 10801]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0377 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Tobacco Health Document
Submission.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#540406150720353232143230357a3c3c277a333b22"><span class="__cf_email__" data-cfemail="1a4a485b496e7b7c7c5a7c7e7b34727269347d756c">[email protected]</span></a>.
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.
Tobacco Health Document Submission
OMB Control Number 0910-0654--Extension
On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act) (Pub. L. 111-31) was enacted. The Tobacco
Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act)
by adding, among other things, a new chapter granting FDA important
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect the public health generally and to reduce
tobacco use by minors. Additionally, section 101 of the Tobacco Control
Act amended the FD&C Act by adding, among other things, new section
904(a)(4) (21 U.S.C. 387d(a)(4)).
Section 904(a)(4) of the FD&C Act requires each tobacco product
manufacturer or importer, or agent thereof, to submit all documents
developed after June 22, 2009, ``that relate to health, toxicological,
behavioral, or physiologic effects of current or future tobacco
products, their constituents (including smoke constituents),
ingredients, components, and additives'' (herein referred to as
``tobacco health documents'').
The guidance document ``Health Document Submission Requirements for
Tobacco Products (Revised)'' (2017) (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-health-document-submission">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-health-document-submission</a>) requests health documents based on statutory requirements
and compliance dates.\1\ As indicated in the guidance, all
manufacturers and importers of tobacco products are now subject to the
FD&C Act and are required to comply with section 904(a)(4), which
requires immediate and ongoing submission of health documents developed
after June 22, 2009 (the date of enactment of the Tobacco Control Act).
However, FDA generally does not intend to enforce the requirement at
this time with respect to
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all such health documents, so long as a specified set of documents,
those developed between June 23, 2009, and December 31, 2009, are
provided at least 90 days prior to the delivery for introduction of
tobacco products into interstate commerce. Thereafter, manufacturers
should preserve all health documents, including those that relate to
products for further manufacturing and those developed after December
31, 2009, for future submission to FDA. All Agency guidance documents
are issued in accordance with our good guidance practice regulations in
21 CFR 10.115, which provide for public comment at any time.
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\1\ FDA announced the availability of a guidance on this
collection in the Federal Register on April 20, 2010 (75 FR 20606)
(revised December 5, 2016 (81 FR 87565)).
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FDA is planning revisions to the guidance to reflect that the
deemed tobacco product compliance period has passed. Additional
revisions include clarifying and editorial changes to promote a better
understanding of FDA's interpretation of the ``health, toxicological,
behavioral, or physiologic'' phrase, examples of health, toxicological,
behavioral, or physiologic effects documents, and minor updates to the
metadata list.
FDA has been collecting the information submitted pursuant to
section 904(a)(4) of the FD&C Act through a facilitative electronic
form and through a paper form (Form FDA 3743) for those individuals who
choose not to use the electronic method. On both forms, FDA is
requesting the following information from firms that have not already
reported or still have documents to report:
<bullet> Submitter identification
<bullet> Submitter type, company name, address, country, company
headquarters Dun and Bradstreet D-U-N-S number, and FDA assigned
Facility Establishment Identifier (FEI) number
<bullet> Submitter point of contact
<bullet> Contact name, title, position title, email, telephone, and
Fax
<bullet> Submission format and contents (as applicable)
<bullet> Electronic documents: Media type, media quantity, size of
submission, quantity of documents, file type, and file software
<bullet> Paper documents: Quantity of documents, quantity of
volumes, and quantity of boxes
<bullet> Whether or not a submission is being provided
<bullet> Confirmation statement
<bullet> Identification and signature of submitter including name,
company name, address, position title, email, telephone, and Fax
<bullet> Document categorization (as applicable): Relationship of
the document or set of documents to the following:
[cir] Health, behavioral, toxicological, or physiological effects
[cir] Uniquely identified current or future tobacco product(s)
[cir] Category of current or future tobacco product(s)
[cir] Specific ingredient(s), constituent(s), component(s), or
additive(s)
[cir] Class of ingredient(s), constituent(s), component(s), or
additive(s)
<bullet> Document readability and accessibility: Keywords; glossary
or explanation of any abbreviations, jargon, or internal (e.g., code)
names; special instructions for loading or compiling submission.
<bullet> Document metadata: Date document was created, document
author(s), document recipient(s), document custodian, document title or
identification number, beginning and ending Bates numbers, Bates number
ranges for documents attached to a submitted email, document type, and
whether the document is present in the University of California San
Francisco's Truth Tobacco Documents database.
You may access the electronic form and paper form on our website,
at <a href="https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal">https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal</a> and <a href="https://www.fda.gov/media/78652/download">https://www.fda.gov/media/78652/download</a>, respectively.
In addition to the electronic and paper forms, FDA issued the guidance
on this collection to assist persons making tobacco health document
submissions. For further assistance, FDA is providing a technical
guide, embedded hints, and a web tutorial on the electronic portal.
FDA issued a final rule to deem products meeting the statutory
definition of ``tobacco product'' to be subject to the FD&C Act on May
10, 2016 (81 FR 28973), which became effective on August 8, 2016. The
FD&C Act provides FDA authority to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco (RYO), smokeless tobacco, and any other
tobacco products that the Agency by regulation deems to be subject to
the law. This final rule extended the Agency's ``tobacco product''
authorities to all other categories of products that meet the statutory
definition of ``tobacco product'' in the FD&C Act, except accessories
of such deemed tobacco products.
For tobacco products subject to the deeming rule, FDA understands
``current or future tobacco products'' to refer to products
commercially distributed on or after August 8, 2016, or products in any
stage of research or development at any time after August 8, 2016,
including experimental products and developmental products intended for
introduction into the market for consumer use. For cigarettes,
cigarette tobacco, RYO, and smokeless tobacco, FDA understands
``current or future tobacco products'' to refer to products
commercially distributed on or after June 23, 2009, or products in any
stage of research or development at any time after June 23, 2009,
including experimental products and developmental products intended for
introduction into the market for consumer use.
In the guidance on this collection, FDA indicated our intent to
enforce the requirement at this time with respect to all such health
documents relating to the deemed tobacco products, so long as a
specified set of documents, those developed between June 23, 2009, and
December 31, 2009, were submitted by February 8, 2017, or in the case
of small-scale deemed tobacco product manufacturers (small-scale
manufacturers), by November 8, 2017 (81 FR 28973 at 29008 and 29009).
Additionally, FDA extended the compliance deadlines by an additional 6
months for small-scale manufacturers in the areas impacted by natural
disasters to May 8, 2018. Thereafter, FDA's compliance plan requested
deemed manufacturers provide tobacco health document submissions from
the specified period, at least 90 days prior to the delivery for
introduction into interstate commerce of tobacco products to which the
health documents relate. Manufacturers or importers of cigarettes,
cigarette tobacco, RYO, or smokeless tobacco products must provide all
health documents developed between June 23, 2009, and December 31,
2009, at least 90 days prior to the delivery for introduction of
tobacco products into interstate commerce.
FDA estimates the burden of this collection of information as
follows:
[[Page 10803]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Tobacco Health Document Submissions and Form FDA 3743.............. 10 3.2 32 50 1,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of documents received each year since the original
collection period has fallen to less than 5 percent of what was
received in the original collection period. FDA expects this is because
documents created within the specified period should have already been
submitted. The Agency bases this estimate on the total number of
tobacco firms it is aware of and its experience with document
production and the number of additional documents that have been
reported each year since the original estimate of the reporting burden.
FDA estimates that a tobacco health document submission as required
by section 904(a)(4) of the FD&C Act, will take approximately 50 hours
per submission based on FDA experience. To derive the number of
respondents for this provision, FDA assumes that very few manufacturers
or importers, or agents thereof, would have health documents to submit.
We anticipate documents will be submitted on an annual basis for a
total of 10 respondents. FDA estimates the total annual reporting
burden to be 1,600 hours.
Based on a review of the information collection of our current OMB
approval, we have made no adjustments to our burden estimate.
Dated: February 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03994 Filed 2-24-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on February 25, 2022.
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