Document ID: FDA-2010-N-0074-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments, etc.
Posted Date: 2010-02-18T05:00Z

[Federal Register: February 18, 2010 (Volume 75, Number 32)]
[Notices]               
[Page 7269-7270]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe10-32]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0074]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Registration and Product Listing for Owners and 
Operators of Domestic Tobacco Product Establishments and Listing of 
Ingredients in Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the 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 proposed extension of an 
existing collection of information pertaining to registration and 
product listing for owners and operators of domestic tobacco product 
establishments and to listing of ingredients in tobacco products under 
the Family Smoking Prevention and Tobacco Control Act (the Tobacco 
Control Act).

DATES:  Submit written or electronic comments on the collection of 
information by April 19, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, Jonnalynn.Capezzuto@fda.hhs.gov.

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.

Registration and Product Listing for Owners and Operators of Domestic 
Tobacco Product Establishments and Listing of Ingredients in Tobacco 
Products (OMB Control Number 0910-0650)--Extension

    On June 22, 2009, the President signed the Tobacco Control Act 
(Public Law 111-31) into law. The Tobacco Control Act amended the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.) 
by, among other things, adding a new chapter granting FDA important new 
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(b) of the act (21 U.S.C. 395(b)), as 
amended by the Tobacco Control Act, requires that ``every person who 
owns or operates any establishment in any State engaged in the 
manufacture, preparation, compounding, or processing of a tobacco 
product or tobacco products * * *'' register with FDA the name, places 
of business, and all establishments owned or operated by that person. 
Every person must register by December 31 of each year. Section 
905(i)(1) of the act, as amended by the Tobacco Control Act, requires 
that all registrants ``shall, at the time of registration under any 
such subsection, file with [FDA] a list of all tobacco products which 
are being manufactured, prepared, compounded, or processed by that 
person for commercial distribution,'' along with certain accompanying 
consumer information, such as all labeling and a representative 
sampling of advertisements. Section 904(a)(1) of the act, as amended by 
the Tobacco Control 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 * * * 
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.'' Since the Tobacco Control act was enacted on June 22, 2009, 
the information required under section 904(a)(1) must be submitted to 
FDA by December 22,

[[Page 7270]]

2009, and include the ingredients added as of the date of submission. 
Section 904(c) of the act also requires submission of information 
whenever additives, or the quantities of additives, are changed.
    FDA issued guidance documents on both (1) Registration and Product 
Listing for Owners and Operators of Domestic Tobacco Product 
Establishments (November 12, 2009, 74 FR 58298) and (2) Listing of 
Ingredients in Tobacco Products (December 1, 2009, 74 FR 62795) to 
assist persons making such submissions to FDA under the Tobacco Control 
Act. While electronic submission of registration and product listing 
information and ingredient listing information are not required, FDA is 
strongly encouraging electronic submission to facilitate efficiency and 
timeliness of data management and collection. To that end, FDA designed 
the eSubmitter application to streamline the data entry process for 
registration and product listing and for ingredient listing. This tool 
allows for importation of large quantities of structured data, 
attachments of files (e.g., in portable document format (PDFs) and 
certain media files), and automatic acknowledgement of FDA's receipt of 
submissions. FDA also developed paper forms (FDA Form 3742--
Registration and Listing for Owners and Operators of Domestic Tobacco 
Product Establishments and FDA Form 3743--Listing of Ingredients in 
Tobacco Products) as an alternative submission tool. Both the 
eSubmitter application and the paper forms can be accessed at http://
www.fda.gov/tobacco.
    On September 1, 2009 (74 FR 45219), FDA published notice in the 
Federal Register announcing that a proposed collection of information 
had been submitted to OMB for emergency processing under the Paperwork 
Reduction Act of 1995. On September 15, 2009 (74 FR 47257), FDA 
published a notice correcting the length of the comment period, keeping 
it open until October 1, 2009. On October 13, 2009 (74 FR 52495), FDA 
published a notice reopening the comment period until October 26, 2009. 
Based on comments indicating that the burden estimates were too low, 
FDA has adjusted its original burden estimates. FDA has adjusted its 
burden estimate for registration and product listing for owners and 
operators of domestic establishments under section 905 of the act from 
0.75 hours per response to 3.75 hours per response. FDA has adjusted 
its burden estimate for listing of ingredients under section 904 of the 
act from 0.75 hours per response to 3.0 hours per response. FDA also 
decreased the number of respondents for listing of ingredients under 
section 904 from 100,000 to 11,000 in response to comments that this 
estimate was too high. FDA also added the activity of applying for a 
Dun and Bradstreet D-U-N-S number to the burden of this information 
collection for those who chose to use eSubmitter.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                        Annual Frequency      Total Annual
                  Activity                      No. of  Respondents       per Response        Respondents       Hours per  Response      Total Hours
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Registration and Product Listing for Owners                   100,000                  1              100,000                  3.75              375,000
 and Operators of Domestic Establishments
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Listing of Ingredients                                         11,000                  1               11,000                  3.0                33,000
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Obtaining a Dun and Bradstreet D-U-N-S                          1,550                  1                1,550                  0.5                   775
 Number
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Total                                                         112,550  .................              112,550  ....................              408,775
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3031 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S