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U.S. Department of Health and Human Services

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Percentage of designation submissions reviewed and acted on within 100 days

Dictionary: Designation provides drug companies with incentives. Upon approval or conditional approval of a product, designation provides sponsors with seven years of exclusive marketing rights and an opportunity to apply for grants. A drug company submits a request to OMUMS for a drug to be designated for a specific use. After the designation request is granted, no other identical designation may be granted. However, more than one designation can be granted for the same drug, as long as the designations are for different dosage forms or different intended uses. Designation requires that the drug company actively work toward approval and provide annual reports to OMUMS to show due diligence. Once a drug company receives a drug designation, the company or other organizations or individuals working with the company are eligible for grants through the federal government. This grant money is used to reduce the cost of conducting safety and effectiveness studies.

Information is current as of June 30, 2014.

Fiscal Year - 2011

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TimeFiscal Year TargetPercent
Oct 201090-
Nov 201090100
Dec 201090100
Jan 201190100
Feb 201190100
Mar 201190100
Apr 201190100
May 20119086
Jun 201190100
Jul 201190100
Aug 201190100
Sep 201190100

FY 2011 Overall: 98

Number of designation submissions reviewed within the month that were acted on within 100 days

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A2
Dec 2010N/A2
Jan 2011N/A4
Feb 2011N/A5
Mar 2011N/A7
Apr 2011N/A2
May 2011N/A6
Jun 2011N/A5
Jul 2011N/A7
Aug 2011N/A8
Sep 2011N/A9

FY 2011 Total: 57

Number of designation submissions reviewed and acted on within the month

Fiscal Year - 2011
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A2
Dec 2010N/A2
Jan 2011N/A4
Feb 2011N/A5
Mar 2011N/A7
Apr 2011N/A2
May 2011N/A7
Jun 2011N/A5
Jul 2011N/A7
Aug 2011N/A8
Sep 2011N/A9

FY 2011 Total: 58

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.