[Federal Register Volume 87, Number 85 (Tuesday, May 3, 2022)]
[Notices]
[Pages 26209-26210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed-united-states-february-15-2007). 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 https://www.fda.gov/industry/electronic-submissions-gateway/create-esg-account. 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