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U.S. Department of Health and Human Services

About FDA

Establish an abbreviated regulatory review pathway for biosimilar and interchangeable biological products

A. Establish a process through which the public may provide FDA with input regarding priorities for issuing guidance documents related to licensure of a biosimilar or interchangeable biological product.

Accomplishment: FDA published a Federal Register Notice announcing a Part 15 Hearing which was held in November 2010. The hearing and docket allowed stakeholder groups to provide input to FDA on various issues and challenges associated with implementing an abbreviated approval pathway for biological products that are highly similar or interchangeable with an FDA-licensed biological product. The purpose of this public hearing was to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute. The docket closed on December 31, 2010. Additional information about the public hearing, including transcripts, is available on the FDA website.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Publish Federal Register notice to announce a Part 15 Hearing, with a docket to receive public comment on various issues, including the types of guidance documents industry believes should be a priority for the agency

10/5/2010

Completed 10/5/2010

2. Hold a public Part 15 hearing to receive comments on various issues, including the types of guidance documents industry believes should be a priority for the agency during the early period of implementation

11/2/2010

Completed 11/2/2010

B. Transmit to Congress recommendations for a user fee program for 351(k) applications for FY 2013-2017.

Accomplishment: In order to develop recommendations for a user fee program for 351(k) applications for FYs 2013-2017, FDA opened a public comment period on May 10, 2011 for feedback on proposed principles, fee structure, and performance goals. Following the comment period, FDA held regular consultation meetings with industry and public stakeholders from June 2011 through September 2011. After administration clearance, FDA published a Federal Register Notice outlining the proposed recommendations on December 7th, 2011, and held a public meeting to discuss the proposed recommendations on December 16th, 2011. The docket closed on January 06th, 2012. HHS transmitted the final recommendations to Congress on January 13, 2012. The final recommendations are available on FDA’s website at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm287723.htm.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Publish Federal Register notice requesting input on the identified principles for development of a 351(k) user fee program, FDA’s proposed structure for a 351(k) user fee program that would adhere to these principles, and performance goals for this program.

5/10/2011

Completed 5/10/2011

2. Publish Federal Register notice announcing availability of the draft recommendations for user fees for 351(k) applications for fiscal years 2013-2017, with a docket to receive public comment on such recommendations; hold a meeting at which the public may present its views on such recommendations; and after consideration of such public views and comments, revise such recommendations as necessary

12/31/2011

Completed 1/6/2012

3. Transmit recommendations for user fees for 351(k) applications for fiscal years 2013-2017 to Congress

1/15/2012

Completed 1/13/2012

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

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.