[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52488-52490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22578]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0125]


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of

[[Page 52489]]

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 guidance for industry 
entitled ``Establishing That a Tobacco Product Was Commercially 
Marketed in the United States as of February 15, 2007.''

DATES: Submit either electronic or written comments on the collection 
of information by December 17, 2018.

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 December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 17, 2018. 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are 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 https://www.regulations.gov.
     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:
     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.
     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-2011-D-0125 for the guidance for industry entitled ``Establishing 
That a Tobacco Product Was Commercially Marketed in the United States 
as of February 15, 2007.'' 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 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
     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 https://www.regulations.gov. 
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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.
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 President signed the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law.

[[Page 52490]]

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 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 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.
    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              1,000               1           1,000               5           5,000
 marketing in the United States
 as of 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 2, 2016, it does not intend to initiate 
enforcement for failure to have premarket authorization until August 8, 
2022. When these compliance periods end, FDA expects a drop in the 
number of grandfathered submissions. The number of hours to gather the 
evidence is FDA's estimate of how long it might take one 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 should 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: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22578 Filed 10-16-18; 8:45 am]
 BILLING CODE 4164-01-P


