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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 - 2012

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TimeFiscal Year TargetPercent
Oct 201190100
Nov 201190100
Dec 201190100
Jan 201290100
Feb 201290100
Mar 201290100
Apr 201290100
May 201290100
Jun 201290100
Jul 201290100
Aug 201290100
Sep 201290100

FY 2012 Overall: 100%

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A11
Nov 2011N/A2
Dec 2011N/A8
Jan 2012N/A2
Feb 2012N/A7
Mar 2012N/A3
Apr 2012N/A3
May 2012N/A3
Jun 2012N/A10
Jul 2012N/A4
Aug 2012N/A5
Sep 2012N/A8

FY 2012 Total: 66

Number of designation submissions reviewed and acted on within the month

Fiscal Year - 2012
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2011N/A11
Nov 2011N/A2
Dec 2011N/A8
Jan 2012N/A2
Feb 2012N/A7
Mar 2012N/A3
Apr 2012N/A3
May 2012N/A3
Jun 2012N/A10
Jul 2012N/A4
Aug 2012N/A5
Sep 2012N/A8

FY 2012 Total: 66

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.