Notice2022-09434
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007
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
May 3, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA 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 85 (Tuesday, May 3, 2022)</title>
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[Federal Register Volume 87, Number 85 (Tuesday, May 3, 2022)]
[Notices]
[Pages 26209-26210]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09434]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0125]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishing That a
Tobacco Product Was Commercially Marketed in the United States as of
February 15, 2007
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA 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 June 2, 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
[[Page 26210]]
by using the search function. The OMB control number for this
information collection is 0910-0775. 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#69393b283a1d080f0f290f0d084701011a470e061f"><span class="__cf_email__" data-cfemail="d080829183a4b1b6b690b6b4b1feb8b8a3feb7bfa6">[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.
Establishing That a Tobacco Product Was Commercially Marketed in the
United States as of February 15, 2007
OMB Control Number 0910-0775--Extension
The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA
to regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors. Tobacco products are governed by chapter IX of the FD&C
Act (sections 900 through 920) (21 U.S.C. 387 through 21 U.S.C. 387u).
Section 910 of the FD&C Act (21 U.S.C. 387j) provides for the
submission of applications for review of certain tobacco products. New
tobacco products are those products, including those products in test
markets, not commercially marketed in the United States as of February
15, 2007, or where the modified tobacco product was commercially
marketed in the United States after February 15, 2007 (section
910(a)(1) of the FD&C Act).
To assist new tobacco product manufacturers with requirements in
section 910 of the FD&C Act, we developed the guidance document
entitled, ``Establishing That a Tobacco Product Was Commercially
Marketed in the United States as of February 15, 2007'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed-united-states-february-15-2007">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed-united-states-february-15-2007</a>). The guidance provides information on how a
manufacturer may establish that a tobacco product was commercially
marketed in the United States as of February 15, 2007. The guidance
includes a description of the types of evidence FDA recommends that the
manufacturer submit to demonstrate that a tobacco product was
commercially marketed in the United States as of February 15, 2007.
Examples of such information may include, but are not limited to, the
following: Dated copies of advertisements, dated catalog pages, dated
promotional material, and dated bills of lading. The guidance also
provides instruction on how to submit a request for a Pre-Existing
Tobacco Product status review (Section III.B.).\1\
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\1\ FDA changed the term from ``grandfathered tobacco product''
to ``Pre-Existing Tobacco Product'' in the recently published final
SE (86 FR 55224) and PMTA (86 FR 55300) rules because it more
appropriately describes these products by using the more precise
term ``Pre-Existing'' in place of ``grandfathered.''
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As discussed in the guidance, electronic submission is not
required, although we strongly encourage electronic submission via
FDA's Electronic Submissions Gateway (ESG) using FDA's eSubmitter tool.
FDA's ESG system requires users to apply for a free account before
submitting data, a process which can take 1 to 3 weeks to complete.
Once approved, the user can send all submissions to CTP using the
eSubmitter tool and FDA ESG. Instructions on obtaining an ESG account
are available at <a href="https://www.fda.gov/industry/electronic-submissions-gateway/create-esg-account">https://www.fda.gov/industry/electronic-submissions-gateway/create-esg-account</a>. Alternatively, respondents can mail
submissions to FDA, as instructed in the guidance.
In the Federal Register of December 9, 2021 (86 FR 70139), 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 burden
Activity; guidance document Sec. III.B Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
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Submit evidence of commercial marketing in the United States as of 1,000 1 1,000 5 5,000
February 15, 2007.................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's estimate of the number of respondents is based on the fact
that submissions are voluntary and also on the pre-existing status of a
tobacco product submissions received. The number of hours to gather the
evidence is FDA's estimate of how long it might take a manufacturer to
review, gather, and submit dated information if making a request for
Agency determination.
FDA further estimates it would take a manufacturer approximately 5
hours to put together this collection of evidence and to submit the
package to FDA for review. FDA estimates that it would take
approximately 5,000 hours annually to respond to this collection of
information.
Dated: April 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09434 Filed 5-2-22; 8:45 am]
BILLING CODE 4164-01-P
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