Document ID: FDA-2012-N-0882-0026
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 Intent To Participate; Extension of Closing Date
Posted Date: 2015-08-12T04:00Z

[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Page 48325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19768]

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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 Intent To Participate; Extension of Closing Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for notification of intent to participate; 
extension of closing date.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
closing date for the document that appeared in the Federal Register of 
June 3, 2015. In that document, FDA requested 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 the request for notification is to ensure continuity and 
progress in these monthly discussions by establishing consistent 
stakeholder representation.

DATES: FDA is extending the closing date in the notice published June 
3, 2015 (80 FR 31602). Submit notification of intent to participate by 
April 30, 2016.

ADDRESSES: Submit notification of intent 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 initiated this process on June 15, 2015, by holding a 
public meeting at which stakeholders and other members of the public 
were given an opportunity to present their views on reauthorization 
(April 21, 2015, 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 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 April 30, 
2016. 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: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19768 Filed 8-11-15; 8:45 am]
 BILLING CODE 4164-01-P