Document ID: FDA-2011-N-0015-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application Form for Orphan Medicinal Product Designation
Posted Date: 2011-11-14T05:00Z

[Federal Register Volume 76, Number 219 (Monday, November 14, 2011)]
[Notices]
[Pages 70461-70462]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29296]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0015]

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Orphan Drugs; Common European 
Medicines Agency/Food and Drug Administration Application Form for 
Orphan Medicinal Product Designation (Food and Drug Administration Form 
3671)

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 ``Orphan Drugs; Common European 
Medicines Agency/Food and Drug Administration Application Form for 
Orphan Medicinal Product Designation (FDA Form 3671)'' has been 
approved by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995.

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, Jonnalynn.Capezzuto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On June 29, 2011, the Agency submitted a 
proposed collection of information entitled ``Orphan Drugs; Common 
European Medicines Agency/Food and Drug Administration Application Form 
for Orphan Medicinal Product Designation (FDA Form 3671)'' 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

[[Page 70462]]

collection and has assigned OMB control number 0910-0167. The approval 
expires on October 31, 2014. 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 7, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-29296 Filed 11-10-11; 8:45 am]
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