Document ID: FDA-2011-N-0830-0029
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Abbreviated New Drug Applications
and 505(b)(2) Applications
Posted Date: 2016-11-29T05:00Z

[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Page 85967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28655]

[[Page 85967]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0830]

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Abbreviated New Drug Applications 
and 505(b)(2) Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Abbreviated New Drug Applications 
and 505(b)(2) Applications'' 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, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On October 6, 2016, the Agency submitted a 
proposed collection of information entitled ``Abbreviated New Drug 
Applications and 505(b)(2) Applications'' 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 
0910-0786. The approval expires on November 30, 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: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28655 Filed 11-28-16; 8:45 am]
 BILLING CODE 4164-01-P