2011-1276. Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 information request regarding the Guidance for Industry and FDA Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.

DATES:

Submit either electronic or written comments on the collection of information by March 25, 2011.

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. [e-mail].

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.

Information Request Regarding Guidance for Industry and FDA Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products (OMB Control Number 0910-0673—Extension)

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by 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(j) of the FD&C Act authorizes FDA to establish the form for the submission of information related to substantial equivalence (21 U.S.C. 387e(j)). In a level 1 guidance document issued under the Good Guidances Practices regulation (21 CFR 10.115), FDA provides recommendations intended to assist persons submitting reports under section 905(j) of the FD&C Act, and explains, among other things, FDA's interpretation of the statutory sections related to substantial equivalence.

Estimation of Burden

FDA estimates the burden for this collection of information as follows:

Table 1—Estimated Annual Reporting Burden

FD&C Act sections	Number of respondents	Annual frequency per response	Total annual responses	Hours per response	Total hours
905(j) and 910(a)	150	1	150	360	54,000
Total					54,000
There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA has based these estimates on information related to other regulated products and FDA's expectations regarding the tobacco industry's use of the 905(j) pathway to market their products. Table 1 of this document describes the annual reporting burden as a result of the implementation of the substantial equivalence requirements of sections 905(j) and 910(a) of the FD&C Act (21 U.S.C. 387e(j) and 387j(a)). FDA estimates that it will receive 150 section 905(j) reports each year and that it will take a manufacturer approximately 360 hours to prepare a report of substantial equivalence for a new tobacco product. Therefore, FDA estimates the burden for submission of substantial equivalence information will be 54,000 hours.

Dated: January 14, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.