
[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42825-42826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0128]


Prescription Drug User Fee Act; Stakeholder Consultation Meetings 
on the Prescription 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--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 Prescription Drug 
User Fee Act (PDUFA). The statutory authority for PDUFA expires in 
September 2017. At that time, new legislation will be required for FDA 
to continue collecting user fees for the prescription 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 PDUFA program. The FD&C Act also requires that FDA hold 
discussions (at least every month) with patient and consumer advocacy 
groups 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 in these series 
of meetings by August 28, 2015. Stakeholder meetings will be held 
monthly. It is anticipated that they will commence in September or 
October 2015.

ADDRESSES: Submit notification of intention to participate in monthly 
stakeholder meetings by email to PDUFAReauthorization@fda.hhs.gov. The 
meetings will be held at the FDA campus, 10903 New Hampshire Ave., 
Silver Spring, MD 20993.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-
5003, FAX: 301-847-8443.

SUPPLEMENTARY INFORMATION:

I. Background

    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 stakeholder consultation meetings on the reauthorization of 
PDUFA. PDUFA authorizes FDA to collect user fees from the regulated 
industry for the process for the review of human drugs. The 
authorization for the current program (PDUFA V) expires in September 
2017. Without new legislation, FDA will no longer be able to collect 
user fees for future fiscal years to fund the human drug review 
process.
    Section 736B(d) of the FD&C Act (21 U.S.C. 379h-2(d)) requires that 
FDA consult with a range of stakeholders, including representatives 
from patient and consumer groups, health care professionals, and 
scientific and academic experts, in developing recommendations for the 
next PDUFA program. FDA will initiate the reauthorization process by 
holding a public meeting on July 15, 2015, where stakeholders and other 
members of the public will be given an opportunity to

[[Page 42826]]

present their views on the reauthorization. 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. It is 
anticipated that these monthly stakeholder consultation meetings will 
commence in September or October 2015.
    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 the periodic 
stakeholder consultation meetings on PDUFA 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 the stakeholder consultation meetings, 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 stakeholder consultation discussions while FDA 
negotiates with the regulated industry. If a stakeholder decides to 
participate in these monthly meetings at a later time, that stakeholder 
may join the remaining monthly stakeholder consultation meetings after 
notifying FDA of this intention (see ADDRESSES). These stakeholder 
discussions will satisfy the consultation requirement in section 
736B(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 PDUFA reauthorization, please provide 
notification by email to PDUFAReauthorization@fda.hhs.gov by August 28, 
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 after FDA receives this notification.

    Dated: July 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17684 Filed 7-17-15; 8:45 am]
 BILLING CODE 4164-01-P


