Document ID: FDA-2020-N-1861-0001
Agency: fda
Document Type: Notice
Title: Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee
Amendments of 2017 Reauthorization; Request for Notification of Stakeholder Intention To Participate
Posted Date: 2020-09-15T04:00Z

[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Pages 57219-57220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20334]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1861]

Generic Drug User Fees; Stakeholder Meetings on Generic Drug User 
Fee Amendments of 2017 Reauthorization; Request for Notification of 
Stakeholder Intention To Participate

AGENCY: Food and Drug Administration, Health and Human Services (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 Generic Drug User 
Fee Amendments of 2017 (GDUFA). At the end of September 2022, new 
legislation will be required for FDA to continue collecting generic 
drug user fees for subsequent fiscal years for the generic 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 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 in these series 
of meetings by October 8, 2020. Stakeholder meetings will be held 
monthly, and it is anticipated that they will commence in October 2020.

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 GenericDrugPolicy@fda.hhs.gov. 
See the SUPPLEMENTARY INFORMATION section for registration date and 
information.

[[Page 57220]]

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 3334, Silver Spring, MD 20993, 240-402-8926, 
Dat.Doan@fda.hhs.gov; or Tiana Barnes, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6196, Silver Spring, MD 20993, 301-796-2882, 
Tiana.Barnes@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 
GDUFA. GDUFA authorizes FDA to collect user fees from the regulated 
industry for the current program (GDUFA II). At the end of September 
2022, new legislation will be required for FDA to continue collecting 
user fees for subsequent fiscal years for the generic drug program. 
Without new legislation, FDA will no longer be able to collect user 
fees for future fiscal years to fund human generic drug activities. 
Section 744C(f) (21 U.S.C. 379j-43(f)) 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, healthcare professionals, and scientific and academic 
experts. FDA initiated this process by holding a public meeting on July 
21, 2020, at which stakeholders and other members of the public were 
given an opportunity to present their views on reauthorization (85 FR 
38378). 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 October 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 periodic 
stakeholder consultation meetings on GDUFA 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 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 consultation requirement in section 
744C(f)(3) (21 U.S.C. 379j-43(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 GDUFA reauthorization, please provide 
notification by email to GenericDrugPolicy@fda.hhs.gov by October 8, 
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. Information 
concerning GDUFA, including the text of the law, the GDUFA II 
Commitment Letter, key Federal Register documents, GDUFA-related 
guidances, performance reports, and financial reports may be found on 
the FDA website at https://www.fda.gov/gdufa.

    Dated: September 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20334 Filed 9-14-20; 8:45 am]
BILLING CODE 4164-01-P