[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32483-32484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13671]



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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; Meetings on 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 reauthorization of the Prescription Drug User 

Fee Act (PDUFA). The statutory authority for PDUFA expires in September 

2012. 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 act) requires that FDA 

consult with a range of stakeholders in developing recommendations for 

the next PDUFA program. The 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 discussions by establishing consistent stakeholder 

representation.



DATES: Submit notification of intention to participate by June 25, 

2010. The first stakeholder meeting will be held on July 1, 2010, from 

9 a.m. to 11 a.m. Stakeholder discussions will continue at least 

monthly during reauthorization negotiations with the regulated 

industry.



ADDRESSES: Submit notification of intention to participate in monthly 

stakeholder meetings by e-mail to [email protected]. The 

first stakeholder meeting will be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, rm. 1503C, Silver Spring, MD 20993.



FOR FURTHER INFORMATION CONTACT: Patrick Frey, Food and Drug 

Administration, Center for Drug Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 51, rm. 1174, Silver Spring, MD 20993, 301-796-

3844, FAX: 301-847-8443.



SUPPLEMENTARY INFORMATION:



I. Introduction



    The authority for PDUFA expires in September 2012. Without new 

legislation to reauthorize the program, FDA will no longer be able to 

collect user fees to fund the human drug review process. Section 

736B(d)(1) (21 U.S.C. 379h-2(d)(1)) of the act requires that FDA 

consult with a range of groups in developing recommendations for the 

next PDUFA program, including scientific and academic experts, health 

care professionals, and representatives from patient and consumer 

groups. FDA initiated this process of consultation on April 12, 2010, 

by holding a public meeting where stakeholders and other members of the 

public were given an opportunity to present their views on 

reauthorization (75 FR 12555, March 16, 2010). This meeting and written 

comments submitted to the docket have provided critical input as the 

Agency prepares for reauthorization discussions. Section 736B(d)(3) of 

the 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 their views on the 

reauthorization, including suggested changes to the PDUFA program.

    FDA is issuing this Federal Register notice to request that 

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 

reauthorization of PDUFA. 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 future 

stakeholder discussions while FDA



[[Page 32484]]



negotiates with the regulated industry. If a stakeholder decides to 

participate in these monthly meetings at a later time, they may still 

participate in remaining monthly meetings by notifying FDA (see 

ADDRESSES). These stakeholder discussions will satisfy the requirement 

in section 736B(d)(3) of the act.



II. Additional Information on PDUFA



    There are several sources of information on FDA's Web site that may 

serve as useful resources for stakeholders participating in the 

periodic consultation meetings:

     Information on the April 2010 public meeting on PDUFA 

Reauthorization, the Federal Register notice announcing the meeting, 

and the transcript of the meeting are available at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm117890.htm. The slide 

presentations from the meeting can be found at http://www.regulations.gov using Docket No. FDA-2010-N-0128.

     FDA created a webinar on the PDUFA program, drug 

development, and FDA's drug review in PDUFA IV. These presentations are 

available at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm207597.htm.

     Key Federal Register documents, PDUFA-related guidances, 

legislation, performance reports, and financial reports and plans are 

posted at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm.

     The Food and Drug Administration Amendments Act of 2007 

(FDAAA)-specific information is available at: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm



III. Notification of Intent to Participate in Periodic Consultation 

Meetings



    If you intend to participate in continued periodic stakeholder 

consultation meetings regarding PDUFA Reauthorization, please provide 

notification by e-mail to [email protected] by June 25, 

2010. Your e-mail should contain complete contact information, 

including name, title, affiliation, address, e-mail 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: June 2, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-13671 Filed 6-7-10; 8:45 am]

BILLING CODE 4160-01-S