[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40662-40663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14585]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1538]


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, healthcare 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 2022. 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 (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 17, 2020. Stakeholder meetings will be held 
monthly. It is anticipated that they will commence in September 2020. 
See the SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The meetings will take place virtually and will be held by 
webcast only. Submit notification of intention to participate in 
monthly stakeholder meetings by email to 
PDUFAReauthorization@fda.hhs.gov.

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 20993-0002, 301-
796-5003, Graham.Thompson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is requesting that public stakeholders--including patient and 
consumer advocacy groups, healthcare 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 VI) expires in September 
2022. 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(f)(1) of the FD&C Act (21 U.S.C. 379h-2(f)(1)) 
requires that FDA consult with a range of stakeholders, including 
representatives from patient and consumer groups, healthcare 
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 23, 2020, 
where stakeholders and other members of the public will be given an 
opportunity to 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 2020.
    FDA is issuing this Federal Register notice to request that 
stakeholder representatives from patient and consumer groups, 
healthcare 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

[[Page 40663]]

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(f)(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 17, 
2020. 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 1. 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14585 Filed 7-6-20; 8:45 am]
BILLING CODE 4164-01-P


