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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 December 31, 2013.

Fiscal Year - 2013

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TimeFiscal Year TargetPercent
Oct 201290100
Nov 201290100
Dec 201290100
Jan 201390100
Feb 201390100
Mar 201390100
Apr 201390100
May 201390100
Jun 201390100
Jul 201390100
Aug 201390100
Sep 201390100

FY 2013 Overall: 100%

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

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A3
Nov 2012N/A3
Dec 2012N/A5
Jan 2013N/A1
Feb 2013N/A10
Mar 2013N/A7
Apr 2013N/A11
May 2013N/A5
Jun 2013N/A6
Jul 2013N/A6
Aug 2013N/A4
Sep 2013N/A4

FY 2013 Total: 65

Number of designation submissions reviewed and acted on within the month

Fiscal Year - 2013
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2012N/A3
Nov 2012N/A3
Dec 2012N/A5
Jan 2013N/A1
Feb 2013N/A10
Mar 2013N/A7
Apr 2013N/A11
May 2013N/A5
Jun 2013N/A6
Jul 2013N/A6
Aug 2013N/A4
Sep 2013N/A4

FY 2013 Total: 65

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.