[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Page 18991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07377]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0656]


Animal Drug User Fee Act; Stakeholder Consultation Meetings on 
the Animal 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 Drug User Fee Act (ADUFA). The statutory 
authority for ADUFA expires September 30, 2023. The Federal Food, 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 ADUFA 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 ADUFA 
reauthorization by May 20, 2021. These stakeholder meetings are 
expected to commence in October 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, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Introduction

    In 2018 Congress passed the Animal Drug User Fee Amendments of 2018 
(Pub. L. 115-234; ADUFA IV). The authority for ADUFA IV 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 new animal drug review process. Section 740A(d)(1) of the 
FD&C Act (21 U.S.C. 379j-13(d)(1)) requires that FDA consult with a 
range of stakeholders in developing recommendations for consideration 
for the next ADUFA 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 740A(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 ADUFA 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 ADUFA 
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 discussions 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 740A(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 ADUFA reauthorization, please submit 
notification by email to: [email protected] 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 meetings 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. 2021-07377 Filed 4-9-21; 8:45 am]
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