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FDA Announces 2017 Public Meetings and Comment Period on Reauthorization of Two Animal Drug User Fee Programs

FDA Announces 2017 Public Meetings and Comment Period on Reauthorization of Two Animal Drug User Fee Programs

October 4, 2017

The U.S. Food and Drug Administration will hold public meetings to offer opportunity for discussion on the proposed recommendations for reauthorization of the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA). The recommendations will be published and posted online when available, prior to the meeting on November 2, 2017. Interested parties can share their comments at the meeting or by submitting them to the public docket electronically or by mail as described below.

ADUFA and AGDUFA give the FDA the authority to collect user fees that provide funding to support the new animal drug and generic new animal drug review processes, respectively. These resources support the FDA’s responsibility to review these drugs for safety and effectiveness and to enhance the timeliness and predictability of application reviews. These programs expire on September 30, 2018. Without new legislation reauthorizing these programs, FDA will no longer have the authority to collect user fees to help fund the new animal drug and generic new animal drug review processes.

Date and Time

November 2, 2017
9 a.m. to 12 p.m.: ADUFA public meeting
1 p.m. to 4 p.m.: AGDUFA public meeting

Location

Food and Drug Administration - Center for Veterinary Medicine
7500 Standish Place, 1st Floor, Room N149
Rockville, MD 20855

Registration and Public Comment

Registration to attend these public meetings is free and available on a first-come, first-served basis. Early registration is recommended due to limited seating. Onsite registration on the day of the public meetings will be based on space availability. If you wish to attend and/or present at one or both public meetings, please register by email to Cassie.Ravo@fda.hhs.gov by October 26, 2017, midnight Eastern Time. Additional information about registration is available at the following links:

If attendees need special accommodations due to a disability, please contact Cassie Ravo at Cassie.Ravo@fda.hhs.gov or 240-402-6866 no later than October 26, 2017.

The U.S. Food and Drug Administration will also offer virtual attendance for these public meetings scheduled:

Event: ADUFA IV Public Meeting

Event address for attendees: https://fda.webex.com/fda/onstage/g.php?MTID=e9adcd215b7dba5d99361b002663e51fe
Date and time: Thursday, November 2, 2017, 9 a.m. Eastern Daylight Time (New York, GMT-4)
Duration: 3 hours
Event number: 812 395 634
Event password: 110217
Teleconference: Provide your number when you join the event to receive a call back. (1) Call one of the following numbers: Local: 1-301-796-7777; toll free: 1-855-828-1770. (2) Follow the instructions that you hear on the phone. Cisco Unified Meeting Place meeting ID: 812 395 634.

Event: AGDUFA III Public Meeting

Event address for attendees: https://fda.webex.com/fda/onstage/g.php?MTID=ec1c356734bcf010b59e0b885726ccad0
Date and time: Thursday, November 2, 2017, 1 p.m. Eastern Daylight Time (New York, GMT-4)
Duration: 3 hours
Event number: 817 527 611
Event password: 110217
Teleconference: Provide your number when you join the event to receive a call back. (1) Call one of the following numbers: Local: 1-301-796-7777; toll free: 1-855-828-1770. (2) Follow the instructions that you hear on the phone. Cisco Unified Meeting Place meeting ID: 817 527 611.

Public comments will be accepted through November 17, 2017, electronically via the Federal eRulemaking Portal http://www.regulations.gov, or in writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20952. All comment submissions received must reference Docket No. FDA-2011-N-0656 for ADUFA, and Docket No. FDA-2011-N-0655 for AGDUFA. Comments received by November 17, 2017, will be published online.

Confidential Submissions –To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. For detailed instructions, refer to:

Additional Information

Contact FDA

Cassie Ravo, Program Analyst
Email: Cassie.Ravo@fda.hhs.gov
Phone: 240-402-6866