[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Notices]
[Pages 60055-60057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24989]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0212]
Draft Guidance for Industry: Applications for Premarket Review of
New Tobacco Products; Availability; Agency Information Collection
Activities; Proposed Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Applications
for Premarket Review of New Tobacco Products.'' The draft guidance is
intended to assist persons submitting applications for new tobacco
products under the Federal Food, Drug, and Cosmetic Act (the FD&C Act),
as amended by the Family Smoking Prevention and Tobacco Control Act
(Tobacco Control Act). The draft guidance explains, among other things,
for new tobacco product applications, who submits, when and how to
submit, what information the FD&C Act requires applicants to submit,
and what information FDA recommends that applicants submit.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by December 27, 2011.
ADDRESSES: Submit electronic comments on the draft guidance, including
comments on the proposed collection of information, to http://www.regulations.gov.
Submit written comments on the draft guidance, including comments
regarding the proposed collection of information, to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance
document entitled ``Applications for Premarket Review of New Tobacco
Products'' to the Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send
one self-addressed adhesive
[[Page 60056]]
label to assist that office in processing your request or include a fax
number to which the draft guidance may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance:
James Flahive or Carol Drew, Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 1-877-
287-1373, [email protected].
With regard to the proposed collection of information:
Daniel Gittleson, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., P150-400B, Rockville, MD 20850, 301-
796-5156, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Applications for Premarket Review of New Tobacco Products.'' This
guidance, when finalized, will provide industry with information on how
to submit an application for premarket review of a new tobacco product
as required by section 910 of the FD&C Act (21 U.S.C. 387j). On June
22, 2009, the President signed the Tobacco Control Act (Pub. L. 111-31)
into law. The Tobacco Control Act amends the FD&C Act and grants FDA
authority to regulate the manufacture, marketing and distribution of
tobacco products to protect public health generally and to reduce
tobacco use by minors. Section 910 of the FD&C Act requires that FDA
issue a market authorization order before a tobacco product may be
introduced into interstate commerce when the tobacco product is new or
modified in any way. Where a new tobacco product is not substantially
equivalent to a tobacco product commercially marketed in the United
States as of February 15, 2007, or exempt from the requirement to
obtain a substantial equivalence determination under regulation,
applicants must submit a premarket tobacco product application (PMTA)
under section 910(b) of the FD&C Act and receive a marketing
authorization order under section 910(c)(1)(A)(i) of the FD&C Act prior
to marketing the product.
The draft guidance is intended to assist persons seeking a
marketing authorization order under section 910 in submitting a PMTA.
The guidance discusses, among other things, the statutory requirement
to submit a PMTA, definitions, who submits a PMTA, when a PMTA should
be submitted, how a PMTA should be submitted, how FDA will review a
PMTA, contents of a PMTA, information to support a public health
finding, exemptions for investigational use of new tobacco products,
and confidentiality issues.
II. Significance of Guidance
FDA is issuing this draft guidance document consistent with FDA's
good guidance practices regulations (21 CFR 10.115). The draft
guidance, when finalized, will represent the Agency's current thinking
on ``Applications for Premarket Review of New Tobacco Products.'' It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statute
and regulations.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act (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 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.
Title: Applications for Premarket Review of New Tobacco Products
(OMB Control Number 0910-NEW).
FDA is announcing the availability of the draft guidance entitled
``Applications for Premarket Review of New Tobacco Products.'' This
guidance, when finalized, will provide industry with information on how
to submit an application for premarket review of new tobacco products
as required by section 910 of the FD&C Act.
On June 22, 2009, the President signed the Tobacco Control Act into
law. The Tobacco Control Act grants FDA authority to regulate the
manufacture, marketing, and distribution of tobacco products to protect
public health generally and to reduce tobacco use by minors. Section
910(a)(1) of the FD&C Act requires persons who either create a new
tobacco product that was not commercially marketed in the United States
as of February 15, 2007, or modify a tobacco product in any way after
February 15, 2007, ``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,'' to submit a premarket tobacco product application and
obtain an order from FDA authorizing the marketing of the product
before the product may be introduced or delivered for introduction into
interstate commerce, unless the product has been shown to be
substantially equivalent to a tobacco product commercially marketed in
the United States as of February 15, 2007, or exempt from a substantial
equivalence determination under regulation.
The draft guidance entitled ``Applications for Premarket Review of
New Tobacco Products'' explains the requirements and provides
recommendations for the contents of an application for premarket review
of a new tobacco product including a cover letter, an executive
summary, full reports of all investigations of health risks, a full
statement of all components, ingredients, additives, and properties,
and of the principle or principles of operation of such tobacco
product, a full description of methods of manufacturing and processing,
a listing of all manufacturing, packaging, and control sites for the
product, an explanation of how the product complies with applicable
tobacco product standards, samples and components; and proposed
labeling. As part of the application, if an applicant does not submit
information on any of
[[Page 60057]]
the previously mentioned items, they should include a statement
indicating which information is not being submitted and an explanation
of why the information is not being submitted.
FDA also encourages persons who would like to study their new
tobacco product to meet with the Office of Science at the Center for
Tobacco Products (CTP) to discuss their investigational plan prior to
distributing the product for investigational purposes. The request for
a meeting should be sent in writing to the Director of CTP's Office of
Science and should include adequate information for FDA to assess the
potential utility of the meeting and to identify FDA staff necessary to
discuss proposed agenda items.
FDA is required to deny a PMTA and issue an order that the product
may not be introduced or delivered for introduction into interstate
commerce under section 910(c)(1)(A)(ii) of the FD&C Act if FDA finds
that the manufacturer has not shown that the product is appropriate for
the protection of the public health, the manufacturing methods,
facilities, or controls do not conform to manufacturing regulations
issued under section 906(e) (21 U.S.C. 387f(e)) of the FD&C Act, the
proposed labeling is false or misleading, or the manufacturer has not
shown that the product complies with any tobacco product standard in
effect under section 907 of the FD&C Act (21 U.S.C. 387g).
Under section 902(6)(A) (21 U.S.C. 387b(6)(A)), a tobacco product
is deemed adulterated if it is a new tobacco product and does not have
an order in effect under section 910(c)(1)(A)(i) of the FD&C Act, as
necessary under section 910(a) of the FD&C Act. Under section 301(a) of
the FD&C Act (21 U.S.C. 331(a)), the introduction or delivery for
introduction into interstate commerce of any adulterated tobacco
product is a prohibited act. Violations of section 910 are subject to
regulatory and enforcement action by FDA, including, but not limited
to, seizure and injunction.
Description of respondents: The respondents to this collection of
information are applicants who are responsible for creating and
submitting new tobacco product premarket applications and who wish to
obtain an FDA order to allow them to market their product.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Information collected and FD&C Number of responses per Total annual Hours per Total burden
act section respondents respondent responses response hours
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Obtaining an FDA order 20 1 20 5,000 100,000
authorizing marketing of
tobacco product (the
application) Section
910(a)(1)(B)...................
Request for Meeting with CTP's 18 1 18 4 72
Office of Science to discuss
Investigational Plan...........
21 CFR 25.40 Preparation of an 20 1 20 12 240
Environmental Assessment.......
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Total Reporting Burden Hours .............. .............. .............. .............. 100,312
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that each respondent will take approximately 5,000
hours to complete the information required in table 1 of this document
to obtain an order from FDA allowing the marketing of a new tobacco
product. FDA's estimate includes anticipated burden for the writing of
an application, including intracompany edits and approvals, of
approximately 200 hours. In addition, FDA expects that conducting the
necessary scientific investigations for a new tobacco product will
require, on average, 4,800 hours. FDA also estimates the number of PMTA
applications that FDA expects to receive annually will be 20.
FDA anticipates that 18 potential respondents to this collection of
information may need to meet with CTP's Office of Science to discuss
their investigational plans. To request this meeting, applicants must
compile and submit information to FDA for meeting approval. FDA
estimates that it will take approximately 4 hours to compile this
information, for a total of 72 hours additional burden (18 respondents
x 4 burden hours).
FDA also estimates that 20 potential respondents will take
approximately 12 hours to prepare and submit an environmental
assessment under part 25 (21 CFR part 25) in accordance with the
requirements of Sec. 25.40, as referenced in 21 CFR 1107.1(b)(9).
The total burden for this collection of information is estimated to
be 100,312 hours ((20 respondents multiplied by 5,000 per response)
plus (18 respondents multiplied by 4 hours per response) plus (20
respondents multiplied by 12 hours per response)). These burden
estimates were computed using FDA staff expertise and by reviewing
comments received from recent FDA information collections for other
tobacco-related initiatives.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet may obtain an electronic
version of this guidance document at http://www.regulations.gov or
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: September 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24989 Filed 9-27-11; 8:45 am]
BILLING CODE 4160-01-P