[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Notices]
[Pages 10289-10290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03428]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2253]


Medical Device User Fees; Stakeholder Meetings on Medical Device 
User Fee Amendments of Fiscal Years 2023 to 2027 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 Medical Device User 
Fee Amendments (MDUFA). The statutory authority for MDUFA expires in 
September 2022. At that time, new legislation will be required for FDA 
to continue collecting user fees for the medical device 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 MDUFA 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 public 
stakeholder representation.

DATES: Submit notification of intention to participate in these series 
of meetings by February 26, 2021. Stakeholder meetings will be held 
monthly. It is anticipated that they will commence in March 2021. 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 
MDUFAVReauthorization@fda.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Ellen Olson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1664, Silver Spring, MD 20993, 301-796-4322, 
MDUFAVReauthorization@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 
MDUFA. MDUFA authorizes FDA to collect user fees from the regulated 
industry for the process for the review of medical devices. The 
authorization for the current program (MDUFA IV) expires in September 
2022. Without new legislation, FDA will no longer be able to collect 
user fees for future fiscal years to fund the medical device review 
process.
    Section 738A(b)(1) of the FD&C Act (21 U.S.C. 379j-1(b)(1)) 
requires that FDA consult with a range of stakeholders, including 
representatives from patient and consumer advocacy groups, healthcare 
professionals, and scientific and academic experts, in developing 
recommendations for the next MDUFA program. FDA initiated the 
reauthorization process by holding a public meeting on October 27, 
2020, where stakeholders and other members of the public were given an 
opportunity to present their views on the reauthorization. The FD&C Act 
further requires that FDA continue meeting with the representatives of 
patient and consumer advocacy groups at least once every month during 
negotiations with the regulated industry to continue discussions of 
stakeholder views on the reauthorization and their suggestions for 
changes. It is anticipated that these monthly stakeholder consultation 
meetings will commence in March 2021.
    FDA is issuing this Federal Register notice to request that 
stakeholder representatives from patient and consumer advocacy groups, 
healthcare professional associations, as well as

[[Page 10290]]

scientific and academic experts, notify FDA of their intent to 
participate in the periodic stakeholder consultation meetings on MDUFA 
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, and are otherwise eligible to attend, may 
participate in all stakeholder consultation discussions while FDA 
negotiates with the regulated industry. These stakeholder discussions 
will satisfy the consultation requirement in section 738A(b)(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 MDUFA reauthorization, please provide 
notification by email to MDUFAVReauthorization@fda.hhs.gov by February 
26, 2021. 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 from FDA after the Agency receives 
this notification.

    Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03428 Filed 2-18-21; 8:45 am]
BILLING CODE 4164-01-P


