[Federal Register Volume 74, Number 168 (Tuesday, September 1, 2009)]
[Notices]
[Pages 45219-45221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21099]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0406]


Agency Emergency Processing Under Office of Management and Budget 
Review; Tobacco Product Establishment Registration and Submission of 
Certain Health Information

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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns the submission of tobacco product establishment 
registration and submission of certain health information, including 
ingredient listing and health related documents, as required by The 
Family Smoking Prevention and Tobacco Control Act (FSPTCA).

DATES: Fax written comments on the collection of information by 
September 16, 2009. FDA is requesting approval of this emergency 
processing by September 16, 2009.

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: 202-395-6974. All comments should be identified with the title, 
``Tobacco Product Establishment Registration and Submission of Certain 
Health Information.'' Also include the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. On June 22, 2009, the 
President signed FSPTCA into law (Public Law 111-31). Section 101 of 
FSPTCA amends the Federal Food, Drug, and Cosmetic Act (the act) by 
adding, among other things, new sections 904 (21 U.S.C. 394) and 905 
(21 U.S.C. 395). Section 905 requires the annual registration of any 
``establishment in any State engaged in the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco products.'' 
Section 905 also requires this registration be completed by December 31 
of each year. To allow adequate time for establishment owners and 
operators to complete the registration process, and to match similar 
provisions applicable to other FDA regulated products, FDA plans to 
begin accepting establishment registrations on October 1, 2009.
    Section 904(a)(1) of the act requires each tobacco product 
manufacturer or importer, or agent thereof to submit a listing of all 
ingredients, including tobacco, substances, compounds, and additives 
that are, as of such date, added by the manufacturer to the tobacco, 
paper, filter, or other part of each tobacco product by brand and by 
quantity in each brand and subbrand. Section 904(a)(4) requires each 
tobacco

[[Page 45220]]

product manufacturer or importer, or agent thereof to submit all 
documents developed after enactment of the FSPTCA that relate to 
health, toxicological, behavioral, or physiologic effects of current or 
future tobacco products, their constituents (including smoke 
constituents), ingredients, components, and additives. This information 
must be submitted by December 22, 2009 (6 months after the date of 
enactment of FSPTCA).
    FDA plans to collect the information submission requirements of 
sections 905, 904(a)(1), and 904(a)(4) of the act through a single 
electronic portal. In order to provide respondents with adequate time 
to prepare information for submission, FDA plans to launch the 
electronic portal for the collection of this information on October 1, 
2009. If FDA were to use the normal PRA clearance procedures, the 
availability of the electronic portal and the submission of information 
by respondents could not begin with adequate time to meet the 
respective statutory deadlines.
    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: Tobacco Product Establishment Registration and Submission of 
Certain Health Information
    Description of Respondents: Respondents to this collection of 
information are: (1) All persons who own or operate any establishment 
in any State engaged in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products; and (2) each 
tobacco product manufacturer or importer, or agents thereof.
    FSPTCA amends the act by creating a new category of regulated 
products, tobacco products. FSPTCA creates many new requirements for 
the tobacco industry. Section 101 of FSPTCA amends the act by adding, 
among other things, new sections 904 and 905. Section 905 requires the 
annual registration of any ``establishment in any State engaged in the 
manufacture, preparation, compounding, or processing of a tobacco 
product or tobacco products.'' The Secretary of Health and Human 
Services (the Secretary) has delegated to the Commissioner of Food and 
Drugs (the Commissioner) the responsibility for administering the act, 
including section 905.
    Section 905 requires owners or operators of each establishment to 
register:
    1. Their name,
    2. Places of business,
    3. A list of all tobacco products which are manufactured by that 
person,
    4. A copy of all labeling and a reference to the authority for the 
marketing of any tobacco product subject to a tobacco product standard 
under section 907 of the act (21 U.S.C. 397) or to premarket review 
under section 910 of the act (21 U.S.C. 399a),
    5. A copy of all consumer information and other labeling,
    6. A representative sampling of advertisements,
    7. Upon request made by the Secretary for good cause, a copy of all 
advertisements for a particular tobacco product, and
    8. Upon request made by the Secretary, if the registrant has 
determined that a tobacco product contained in the product list is not 
subject to a tobacco product standard established under section 907, a 
brief statement of the basis upon which the registrant made such 
determination.
    Section 904(a)(1) of the act requires each tobacco product 
manufacturer or importer, or agent thereof to submit a listing of all 
ingredients, including tobacco, substances, compounds, and additives 
that are, as of such date, added by the manufacturer to the tobacco, 
paper, filter, or other part of each tobacco product by brand and by 
quantity in each brand and subbrand. Section 904(a)(4) requires each 
tobacco product manufacturer or importer, or agent thereof, to submit 
all documents developed after enactment of the FSPTCA that relate to 
health, toxicological, behavioral, or physiologic effects of current or 
future tobacco products, their constituents (including smoke 
constituents), ingredients, components, and additives.
    The Secretary has delegated to the Commissioner the responsibility 
for administering the act, including section 904.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                 No. of        Annual Frequency     Total Annual        Hours per
                         Activity                             Respondents        per Response        Responses           Response         Total Hours
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Tobacco Product                                                      100,000                  1            100,000               0.75             75,000
Establishment Registration
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Tobacco Product                                                      100,000                  1            100,000               0.75             75,000
Ingredient Listing
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Documents Related to                                                      10                  1                 10                  1                 10
Health Information
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Total                                                      .................  .................  .................  .................            150,010
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 45221]]

    Dated: August 27, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21099 Filed 8-31-09; 8:45 am]
BILLING CODE 4160-01-S