Document ID: FDA-2011-N-0656-0019
Agency: fda
Document Type: Notice
Title: Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Posted Date: 2016-04-20T04:00Z

[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23305-23306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09151]

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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 or Agency) 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, 2018. The Federal Food, Drug, 
and Cosmetic Act (the 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 continuity and progress in these 
regular discussions by establishing consistent stakeholder 
representation.

DATES: Submit notification of intention to participate in continued 
periodic stakeholder consultation meetings regarding ADUFA 
reauthorization by May 16, 2016. These stakeholder meetings are 
expected to commence in September/October 2016 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 at the Food and Drug 
Administration, Center for Veterinary Medicine, 7519 Standish Pl., 
Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT: Cassie Ravo, Center for Veterinary 
Medicine, Food and Drug Administration,7519 Standish Pl., Rockville, MD 
20855, 240-402-6866, FAX: 240-276-9744, Cassie.Ravo@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In 2013 Congress passed the Animal Drug User Fee Amendments of 2013 
(Pub. L. 113-14; ADUFA III). The authority for ADUFA III expires 
September 30, 2018. Without new legislation to reauthorize the program, 
FDA will no longer be able to collect user fees for future fiscal years 
to fund the 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

[[Page 23306]]

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 16, 2016, 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 will be important to ensure progress 
in these discussions. 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 
ADDRESSES). 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 cvmadufa@fda.hhs.gov by May 16, 2016. 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. Stakeholders will receive confirmation and additional 
information about the first meeting after FDA receives this 
notification.

    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09151 Filed 4-19-16; 8:45 am]
 BILLING CODE 4164-01-P