[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]


-----------------------------------------------------------------------

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Draft Guidance for Industry: Applications for Premarket Review of 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.

-----------------------------------------------------------------------

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availability of a draft guidance for industry entitled ``Applications 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 The draft guidance is 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 The draft guidance explains, among other things, 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES: Submit electronic comments on the draft guidance, including 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    Submit written comments on the draft guidance, including comments 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    Submit written requests for single copies of the draft guidance 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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Information collected and FD&C      Number of     responses per   Total annual      Hours per     Total burden
           act section              respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
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.......
                                 -------------------------------------------------------------------------------
    Total Reporting Burden Hours  ..............  ..............  ..............  ..............         100,312
----------------------------------------------------------------------------------------------------------------
\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