Document ID: FDA-2011-D-0147-0024
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; 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: 2016-02-29T05:00Z

[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Page 10250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04222]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; 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 that a 
collection of information entitled ``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'' has been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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: On July 16, 2015, the Agency submitted a 
proposed collection of information entitled ``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'' to OMB for review and 
clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, 
and a person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number. OMB has now 
approved the information collection and has assigned OMB control number 
0910-0673. The approval expires on January 31, 2019. A copy of the 
supporting statement for this information collection is available on 
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04222 Filed 2-26-16; 8:45 am]
 BILLING CODE 4164-01-P