Document ID: FDA-2011-N-0655-0026
Agency: fda
Document Type: Notice
Title: Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Posted Date: 2021-04-12T04:00Z

[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 18987-18988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07374]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]

Animal Generic Drug User Fee Act; Stakeholder Consultation 
Meetings on the Animal Generic Drug User Fee Act Reauthorization; 
Request for Notification of Stakeholder Intention To Participate

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice: Request for notification of participation.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
issuing this notice to request that public stakeholders notify FDA of 
their intent to participate in periodic consultation meetings on 
reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The 
statutory authority for AGDUFA expires September 30, 2023. The Federal 
Food,

[[Page 18988]]

Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a 
range of stakeholders--including patient and consumer advocacy groups, 
veterinary professionals, and scientific and academic experts--in 
developing recommendations for the next AGDUFA program and hold 
discussions with these stakeholders at least once every 4 months during 
FDA's negotiations with the regulated industry. The purpose of this 
request for notification is to ensure consistent stakeholder 
representation at the consultation meetings.

DATES: Submit notification of intention to participate in continued 
periodic stakeholder consultation meetings regarding AGDUFA 
reauthorization by May 20, 2021. These stakeholder meetings are 
expected to commence on July 2021 and will continue at least once every 
4 months during reauthorization negotiations with the regulated 
industry. See the SUPPLEMENTARY INFORMATION section for further 
information regarding notification of intention to participate.

ADDRESSES: The stakeholder meetings will be held virtually.

FOR FURTHER INFORMATION CONTACT: Lisa Kable, Center for Veterinary 
Medicine, Food and Drug Administration, 240-402-6888, 
Lisa.Kable@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    In 2018 Congress passed the Animal Generic Drug User Fee Amendments 
of 2018 (Pub. L. 115-234; AGDUFA III). The authority for AGDUFA III 
expires September 30, 2023. Without new legislation to reauthorize the 
program, FDA will no longer be able to collect user fees for future 
fiscal years to fund the generic new animal drug review process. 
Section 742(d)(1) of the FD&C Act (21 U.S.C. 379j-22(d)(1)) requires 
that FDA consult with a range of stakeholders in developing 
recommendations for consideration for the next AGDUFA program, 
including representatives from patient and consumer advocacy groups, 
veterinary professionals, and scientific and academic experts. To 
initiate this process of consultation, elsewhere in this issue of the 
Federal Register, we are announcing a public meeting to be held on May 
20, 2021, where stakeholders and other members of the public will be 
given an opportunity to present their views on the reauthorization. The 
meeting and written comments submitted to the docket will provide 
critical input as the Agency prepares for reauthorization discussions. 
Section 742(d)(3) of the FD&C Act further requires that FDA continue 
meeting with these stakeholders at least once every 4 months during 
negotiations with the regulated industry to continue discussions of 
their views on the reauthorization, including suggested changes to the 
AGDUFA program.
    FDA is issuing this Federal Register notice to request that 
stakeholders--including veterinary, patient and consumer groups, as 
well as scientific and academic experts--notify FDA of their intent to 
participate in the periodic consultation meetings on AGDUFA 
reauthorization. FDA believes that consistent stakeholder 
representation at these meetings is essential in the reauthorization 
process. If you wish to participate in this part of the reauthorization 
process, please designate one or more representatives from your 
organization who will commit to attending these meetings and preparing 
for the discussions. Stakeholders who identify themselves through this 
notice will be included in all future stakeholder discussion while FDA 
negotiates with the regulated industry. If a stakeholder decides to 
participate in these meetings at a later time, they may still 
participate in remaining meetings by notifying FDA (see FOR FURTHER 
INFORMATION CONTACT). These stakeholder discussions will satisfy the 
requirement in section 742(d)(3) of the FD&C Act.

II. Notification of Intent To Participate in Periodic Stakeholder 
Consultation Meetings

    If you intend to participate in continued periodic stakeholder 
consultation meetings regarding AGDUFA reauthorization, please submit 
notification by email to: cvmagdufa@fda.hhs.gov by May 18, 2021. Your 
email should contain complete contact information for each attendee, 
including name, title, affiliation, address, email address, telephone 
number, and notice of any special accommodations required due to a 
disability (e.g., Closed Captioning). Stakeholders will receive 
confirmation and additional information about the first meeting, and 
subsequent meeting when scheduled, after FDA receives this notification 
of intent to participate.

    Dated: April 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07374 Filed 4-9-21; 8:45 am]
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