Document ID: FDA-2011-N-0655-0011
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: 2016-04-20T04:00Z

[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23304-23305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09152]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 Generic Drug User Fee Act (AGDUFA). The 
statutory authority for AGDUFA 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 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 continuity and progress in these 
regular discussions by establishing consistent stakeholder 
representation.

[[Page 23305]]

DATES: Submit notification of intention to participate in continued 
periodic stakeholder consultation meetings regarding AGDUFA 
reauthorization by May 16, 2016. These stakeholder meetings are 
expected to commence in June/July 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 Generic Drug User Fee Amendments 
of 2013 (Pub. L. 113-14; AGDUFA II). The authority for AGDUFA II 
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 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 
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 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 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 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 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. 2016-09152 Filed 4-19-16; 8:45 am]
 BILLING CODE 4164-01-P