Document ID: FDA-2012-N-0882-0004
Agency: fda
Document Type: Notice
Title: Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee
Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intention To Participate
Posted Date: 2015-06-03T04:00Z

[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Notices]
[Pages 31602-31603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13465]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0882]

Generic Drug User Fees; Stakeholder Meetings on Generic Drug User 
Fee Amendments of 2012 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) is issuing this notice 
to request that public stakeholders, including patient and consumer 
advocacy groups, health care professionals, and scientific and academic 
experts, notify FDA of their intent to participate in periodic 
consultation meetings on the reauthorization of the Generic Drug User 
Fee Amendments of 2012 (GDUFA). The statutory authority for GDUFA 
expires at the end of September 2017. At that time, new legislation 
will be required for FDA to continue collecting user fees for the 
generic drug program. The Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) requires that FDA consult with a range of stakeholders in 
developing recommendations for the next GDUFA program. The FD&C Act 
also requires that FDA hold continued discussions with patient and 
consumer advocacy groups at least monthly during FDA's negotiations 
with the regulated industry. The purpose of this request for 
notification is to ensure continuity and progress in these monthly 
discussions by establishing consistent stakeholder representation.

DATES: Submit notification of intention to participate by August 14, 
2015.

ADDRESSES: Submit notification of intention to participate in monthly 
stakeholder meetings by email to GenericDrugPolicy@fda.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Connie Wisner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1718, Silver Spring, MD 20993-0002, 240-
402-7946, Connie.Wisner@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is requesting that public stakeholders, including patient and 
consumer advocacy groups, health care professionals, and scientific and 
academic experts, notify the Agency of their intent to participate in 
periodic consultation meetings on the reauthorization of GDUFA. GDUFA 
authorizes FDA to collect fees from drug companies that submit 
marketing applications for certain generic human drug applications, 
certain drug master files, and certain facilities. GDUFA requires that 
generic drug manufacturers pay user fees to finance critical and 
measurable generic drug program enhancements. The statutory authority 
for GDUFA expires at the end of September 2017. Without new 
legislation, FDA will no longer be able to collect user fees for future 
fiscal years to fund the human generic drug review process. Section 
744C(d) (21 U.S.C. 379j-43(d)) of the FD&C Act requires that FDA 
consult with a range of stakeholders in developing recommendations for 
the next GDUFA program, including representatives from patient and 
consumer groups, health care professionals, and scientific and academic 
experts. FDA will initiate this process on June 15, 2015, by holding a 
public meeting at which stakeholders and other members of the public 
will be given an opportunity to present their views on reauthorization 
(80 FR 22204). The FD&C Act further requires that FDA continue meeting 
with these stakeholders at least once every month during negotiations 
with the regulated industry to continue discussions of stakeholder 
views on the reauthorization.
    FDA is issuing this Federal Register notice to request that 
stakeholder representatives from patient and consumer groups, health 
care professional associations, as well as scientific and academic 
experts notify FDA of their intent to participate in periodic 
consultation meetings on GDUFA reauthorization. FDA believes that 
consistent stakeholder representation at these meetings will be 
important to ensuring 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 as 
needed. Stakeholders who identify themselves through this

[[Page 31603]]

notice will be included in all stakeholder discussions while FDA 
negotiates with the regulated industry. Stakeholders who decide to 
participate in these monthly meetings at a later time may still 
participate in remaining monthly meetings by notifying FDA (see 
ADDRESSES). These stakeholder discussions will satisfy the requirement 
in section 744C(d)(3) of the FD&C Act.

II. Notification of Intent To Participate in Periodic Consultation 
Meetings

    If you intend to participate in continued periodic stakeholder 
consultation meetings regarding GDUFA reauthorization, please provide 
notification by email to GenericDrugPolicy@fda.hhs.gov by August 14, 
2015. Your email should contain complete contact information, including 
name, title, affiliation, address, email address, phone number, and 
notice of any special accommodations required because of disability. 
Stakeholders will receive confirmation and additional information about 
the first meeting once FDA receives their notification.

    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13465 Filed 6-2-15; 8:45 am]
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