Notice2022-15727
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
July 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 140 (Friday, July 22, 2022)</title>
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[Federal Register Volume 87, Number 140 (Friday, July 22, 2022)]
[Notices]
[Pages 43875-43877]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15727]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0377]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tobacco Health
Document Submission
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: 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 August 22, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0654. Also include the FDA docket
number found in brackets in the heading of this document.
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#68383a293b1c090e0e280e0c094600001b460f071e"><span class="__cf_email__" data-cfemail="f9a9abb8aa8d989f9fb99f9d98d791918ad79e968f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Tobacco Health Document Submission
OMB Control Number 0910-0654--Revision
Section 904(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 387d(a)(4)) 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
[[Page 43876]]
constituents), ingredients, components, and additives'' (herein
referred to as ``tobacco health documents'' or ``health documents'').
The guidance document entitled ``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 tobacco health document
submissions from manufacturers and importers of tobacco products 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) of the FD&C Act, 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 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
[[Page 43877]]
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.
After publication of the 60-day notice however, on March 15, 2022,
President Biden signed H.R. 2471--the Consolidated Appropriations Act,
2022. As a result, the FD&C Act now includes specific language that
makes clear that FDA has the authority to regulate tobacco products
containing nicotine from any source, which includes synthetic. On April
14, 2022, firms engaged in the manufacture, preparation, compounding,
or processing of tobacco products containing non-tobacco nicotine
products (NTN) must therefore provide health documents.
In the Federal Register of February 25, 2022 (87 FR 10800), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Tobacco Health Document 10 3.2 32 50 1,600
Submissions and Form FDA 3743..
Tobacco Health Document 100 1 100 2 200
Submissions and Form 3743 for
Non-Tobacco Nicotine Products
(NTN)..........................
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Total....................... .............. .............. .............. .............. 1,800
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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 annual reporting burden for
these respondents to be 1,600 hours.
As mentioned previously in this document, with the new authority
provided to FDA, firms engaged in the manufacture, preparation,
compounding, or processing of tobacco products containing NTN must
provide health documents. Although these firms are unlikely to have
health documents created within the specified period, we are estimating
for this extension that we will receive 100 new NTN respondents who
will be required to provide a declaration to such effect via Form 3743,
which is expected to take 2 hours, for a total 200 burden hours.
Based on a review of the information collection of our current OMB
approval, we have increased the burden by 200 hours.
Dated: July 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15727 Filed 7-21-22; 8:45 am]
BILLING CODE 4164-01-P
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