[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Pages 26120-26121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11659]


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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; Guidance for Industry 
on 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) 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: Fax written comments on the collection of information by July 5, 
2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0775. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry on Establishing That a Tobacco Product Was 
Commercially Marketed in the United States as of February 15, 2007

OMB Control Number 0910-0775--Extension

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Tobacco Control Act) (Pub. L. 111-31) was signed into law. The 
Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) by adding, among other things, a chapter granting FDA 
authority to regulate the manufacture, marketing, and distribution of 
tobacco products to protect the public health generally and to reduce 
tobacco use by minors.
    Section 201(rr) of the FD&C Act (21 U.S.C.321(rr)), as amended, 
defines a tobacco product as any product made or derived from tobacco 
that is intended for human consumption, including any component, part, 
or accessory of a tobacco product (except for raw materials other than 
tobacco used in manufacturing a component, part, or accessory of a 
tobacco product). Section 910 of the FD&C Act (21 U.S.C. 387j) sets out 
premarket requirements for new tobacco products. The term new tobacco 
product is defined as any tobacco product (including those products in 
test markets) that was not commercially marketed in the United States 
as of February 15, 2007, or any modification (including a change in 
design, any component, any part, or any constituent, including a smoke 
constituent, or in the content, delivery, or form of nicotine, or any 
other additive or ingredient) of a tobacco product where the modified 
product was commercially marketed in the United States after February 
15, 2007 (section 910(a)(1) of the FD&C Act).
    The Tobacco Control Act also gave FDA the authority to issue a 
regulation deeming all 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) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10, 
2016, FDA issued that rule, extending FDA's tobacco product authority 
to all products that meet the definition of tobacco product in the law 
(except for accessories of newly regulated tobacco products), including 
electronic nicotine delivery systems, cigars, hookah, pipe tobacco, 
nicotine gels, dissolvables that were not already subject to the FD&C 
Act, and other tobacco products that may be developed in the future (81 
FR 28974 at 28976).
    FDA refers to tobacco products that were commercially marketed 
(other than exclusively in test markets) in the United States as of 
February 15, 2007, as grandfathered tobacco products. Grandfathered 
tobacco products are not considered new tobacco products and are not 
subject to the premarket requirements of section 910 of the FD&C Act. 
The guidance document associated with this information collection 
provides information on how a manufacturer may establish that a tobacco 
product was commercially marketed in the United States as of February 
15, 2007. A grandfathered

[[Page 26121]]

tobacco product may also serve as the predicate tobacco product in a 
section 905(j) report (intended to be used toward demonstrating 
substantial equivalence) for a new tobacco product (section 
905(j)(1)A)(i) of the FD&C Act (21 U.S.C. 387e(j)(1)(A)(i))).
    The guidance recommends that the manufacturer submit information 
adequate to demonstrate that the 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.
    In the Federal Register of October 17, 2018 (83 FR 52488), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received; however, they 
were not PRA related.
    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
                    FD&C Act sections or action                         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 requesting an Agency determination of the grandfathered status of 
a tobacco product under the guidance is not required and also on the 
number of grandfathered submissions received from 2011 to June 2018. We 
estimate submissions have increased due to the effective date of the 
deeming rule. FDA has stated that, for deemed combustible products that 
were on the market as of August 8, 2016, it does not intend to initiate 
enforcement for failure to have premarket authorization until August 8, 
2021. FDA has also stated that, for deemed noncombustible products that 
were on the market as of August 8, 2016, it does not intend to initiate 
enforcement for failure to have premarket authorization until August 8, 
2022. Because interested persons are seeking information on the 
grandfathered status of tobacco products in advance of these dates, FDA 
expects a drop in the number of grandfathered submissions following 
those dates. 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.
    Our estimated burden for the information collection reflects an 
overall increase of 4,235 hours. We attribute this adjustment to an 
updated number of submissions received through this approval and the 
number of submissions expected in the next 3 years.

    Dated: May 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11659 Filed 6-4-19; 8:45 am]
 BILLING CODE 4164-01-P


