
[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33196-33197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13434]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1558]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
and Food and Drug Administration Staff; Section 905(j) Reports: 
Demonstrating Substantial Equivalence for Tobacco Products

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 
10, 2014.

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 0910-0673. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, 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 and Food and Drug Administration Staff on Section 
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco 
Products--(OMB Control Number 0910-0673)--(Extension)

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 
111-31) into law. The Tobacco Control Act amended the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) by adding a new 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 905(j) of the FD&C Act (21 U.S.C. 
387e(j)) authorizes FDA to establish the form for the submission of 
information related to substantial equivalence. In a level 1 guidance 
document issued under the Good Guidances Practices regulation (21 CFR 
10.115), FDA provides recommendations intended to assist persons 
submitting reports under section 905(j) of the FD&C Act and explains, 
among other things, FDA's interpretation of the statutory sections 
related to substantial equivalence.
    In the Federal Register of December 27, 2013 (78 FR 78974), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Six comment submissions were received, some 
of which included multiple comments. Two of the six comment submissions 
were in favor of FDA's regulation of tobacco products. Three comment 
submissions were considered to contain PRA-related comments and three 
comment submission were not considered to contain PRA-related comments. 
The three comment submissions not considered to contain PRA-related 
comments are beyond the scope of this Federal Register notice.
    (Comment 1) One commenter supported FDA in its mission to regulate 
tobacco products for the benefit of public health and safety and 
indicated that language in the guidance be strengthened to assist in 
FDA reviews. The commenter also suggested that the respondents provide 
additional information to minimize future Freedom of Information Act 
requests.
    (Response 1) FDA agrees that the request in this collection of 
information is necessary to fulfill the requirements of the FD&C Act. 
The type of data for a given new product may vary depending on whether 
the characteristics of the product are the same or different from a 
predicate tobacco product, and the information is needed to allow FDA 
to make informed decisions when reviewing a substantial equivalence 
application.
    (Comment 2) Several commenters indicated that FDA has improperly 
implemented the substantial equivalence provisions of the statute (the 
FD&C Act, as amended by the Family Smoking Prevention and Tobacco 
Control Act (FSPTCA)), and maintain that FDA is asking for reports that 
are neither authorized nor relevant to a substantial equivalence 
determination.
    (Response 2) FDA disagrees with the comment. The information FDA is 
requesting is related to new products using the substantial equivalence 
pathway to assist FDA in making a determination of whether a product is 
substantially equivalent.
    (Comment 3) Several commenters asserted that FDA was not asking for 
enough information, while other commenters asserted that FDA was asking 
for too much information.
    (Response 3) FDA believes that the collection of information is 
necessary and the burden estimates are appropriate and reflect the 
amount of time a respondent would need to prepare a substantial 
equivalence submission.
    (Comment 4) One commenter noted that under FDA's interpretation, 
every new, including modified, product

[[Page 33197]]

automatically will be evaluated. Other commenters questioned FDA's 
implementation and Congress' intent of the FSPTCA and its definition of 
substantial equivalence and new products.
    (Response 4) The FD&C Act as amended by the FSPTCA establishes the 
definition of ``new tobacco product'' and the premarket pathways, of 
which substantial equivalence is one. FDA believes the information 
collection estimates are appropriate and reflect estimates of the time 
it would take to put together and report the information needed in a 
substantial equivalence submission required by the statute.
    (Comment 5) One commenter stated that the commenter believes that 
substantial equivalence reports should be exempt from environmental 
assessment requirements.
    (Response 5) The National Environmental Policy Act and FDA 
implementing regulations require environmental assessment requirements.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                         FD&C Act sections                              Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses       per response
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905(j)(1)(A)(i) and 910(a).........................................           1,000                1            1,000              360          360,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA has based these estimates on information it now has available 
from interactions with the industry, information related to other 
regulated products, and FDA's expectations regarding the tobacco 
industry's use of the section 905(j) pathway to market their products. 
Table 1 describes the annual reporting burden as a result of the 
implementation of the substantial equivalence requirements of sections 
905(j) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)). FDA estimates 
that it will receive 1,000 section 905(j) reports each year and that it 
will take a manufacturer approximately 360 hours to prepare a report of 
substantial equivalence for a new tobacco product. Therefore, FDA 
estimates the burden for submission of substantial equivalence 
information will be 360,000 hours.

    Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13434 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P


