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Notice2013-057262013-03-13

Cooperative Agreement To Support Regulatory Research Related to Food and Drug Administration Commitments Under the 2012 Prescription Drug User Fee Act

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for award of a cooperative agreement to the Brookings Institution's Engelberg Center for Health Care Reform (ECHCR) in support of efforts to inform major initiatives for process improvement and regulatory science related to FDA commitments under the 2012 reauthorization of the Prescription Drug User Fee Act (PDUFA V).

Action & Dates

Action
Notice.
Dates
Important dates are as follows:

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2013-N-0010] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for award of a cooperative agreement to the Brookings Institution's Engelberg Center for Health Care Reform (ECHCR) in support of efforts to inform major initiatives for process improvement and regulatory science related to FDA commitments under the 2012 reauthorization of the Prescription Drug User Fee Act (PDUFA V). DATES: Important dates are as follows: 1. The application due date is April 15, 2013. 2. The anticipated start date is June 1, 2013. 3. The expiration date is April 16, 2013. For Further Information and Additional Requirements Contact: Adam Kroetsch, Office of Planning and Analysis, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993, 301-796-3842, Adam.Kroetsch@fda.hhs.gov ; or Yemisi Akinneye, Office of Acquisitions and Grants Services, Food and Drug Administration, 5630 Fishers Lane, HFA 500, Rm. 2037, Rockville, MD 20857, 301-827-0079, Oluyemisi.Akinneye@fda.hhs.gov . For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at http://grants2.nih.gov/​grants/​guide/​and/​or http://www.fda.gov/​ForIndustry/​UserFees/&#8

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Full Document

Citation: 78 FR 15953