E9-21099. 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.

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: [phone]. 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: [e-mail].

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 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 Burden¹

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

Dated: August 27, 2009.

David Horowitz,

Assistant Commissioner for Policy.