Document ID: FDA-2011-D-0147-0008
Agency: fda
Document Type: Notice
Title: 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 and Demonstrating the Substantial
Equivalence of a New Tobacco Product: Responses to Frequently
Asked Questions
Posted Date: 2015-03-05T05:00Z

[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 11989-11990]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05024]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0147]

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 and Demonstrating the Substantial Equivalence of a 
New Tobacco Product: Responses to Frequently Asked Questions

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

[[Page 11990]]

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 collections in the guidances for industry 
and FDA staff entitled ``Guidance for Industry and Food and Drug 
Administration Staff on Section 905(j) Reports: Demonstrating 
Substantial Equivalence for Tobacco Products'' and ``Demonstrating the 
Substantial Equivalence of a New Tobacco Product: Responses to 
Frequently Asked Questions.''

DATES: Submit either electronic or written comments on the collection 
of information by May 4, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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.

Guidance for Industry and Food and Drug Administration Staff on 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 (the FD&C Act) by adding a new chapter granting 
FDA 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 (21 U.S.C. 
387e(j)) authorizes FDA to establish the form for the submission of 
information related to substantial equivalence (SE). In guidance 
documents 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                              Number of       Total       Average
                  Activity                     Number of    responses per     annual     burden per  Total hours
                                              respondents    respondent     responses     response
----------------------------------------------------------------------------------------------------------------
Full SE 905(j)(1)(A)(i) and 910(a)..........           75               1           75          300       22,500
Product Quantity Change SE Report...........          125               1          125           87       10,875
Same characteristics SE Report..............          100               1          100           47        4,700
                                             -------------------------------------------------------------------
    Totals..................................  ...........  ..............  ...........  ...........       38,075
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA has based these estimates on information it now has available 
from interactions with the industry, information related to other 
regulated products, and FDA's expectations regarding the tobacco 
industry's use of the section 905(j) pathway to market their products. 
Table 1 describes the annual reporting burden as a result of the 
implementation of the SE requirements of sections 905(j) and 910(a) of 
the FDC Act (21 U.S.C. 387j(a)). Based on current information, FDA now 
estimates that it will receive 300 section 905(j) reports each year. Of 
these 300 reports, FDA estimates that 75 of these reports will be 
``full'' SE reports that take a manufacturer approximately 300 hours to 
prepare. Under the newly issued guidance entitled, ``Demonstrating the 
Substantial Equivalence of a New Tobacco Product: Responses to 
Frequently Asked Questions,'' FDA is recommending that certain 
modifications might be addressed in either a ``Same Characteristics SE 
Report'' or ``Product Quantity Change Report.'' FDA estimates that it 
will receive 100 Same Characteristics SE Reports and that it will take 
a manufacturer approximately 47 hours to prepare this report. FDA 
estimates that it will receive 125 Product Quantity Change SE Reports 
and that it will take a manufacturer approximately 87 hours to prepare 
this report. Therefore, FDA estimates the burden for submission of SE 
information will be 38,075 hours.

    Dated: February 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05024 Filed 3-4-15; 8:45 am]
 BILLING CODE 4164-01-P