81 FR 85967 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Abbreviated New Drug Applications and 505(b)(2) Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 229 (November 29, 2016)

Page Range85967-85967
FR Document2016-28655

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.

Federal Register, Volume 81 Issue 229 (Tuesday, November 29, 2016)
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Page 85967]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

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


Current View
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation81 FR 85967 

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