[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Page 25491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09233]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0895]


Issuance of Priority Review Voucher; Material Threat Medical 
Countermeasure Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of a priority review voucher to the sponsor of a material 
threat medical countermeasure (MCM) product application. The Federal 
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century 
Cures Act (Cures Act), authorizes FDA to award priority review vouchers 
to sponsors of approved material threat MCM product applications that 
meet certain criteria. FDA is required to publish notice of the award 
of the priority review voucher. FDA has determined that VEKLURY 
(remdesivir), manufactured by Gilead Sciences, Inc., meets the criteria 
for a material threat MCM priority review voucher.

FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Office of 
Counterterrorism and Emerging Threats, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 301-796-8515, Fax: 301-796-8615, email: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a material 
threat MCM priority review voucher to the sponsor of an approved 
material threat MCM product application. Under section 565A of the FD&C 
Act (21 U.S.C. 360bbb-4a), which was added by the Cures Act (Pub. L. 
114-255), FDA will award priority review vouchers to sponsors of 
approved material threat MCM product applications that meet certain 
criteria upon approval of those applications. FDA has determined that 
VEKLURY, manufactured by Gilead Sciences, Inc., meets the criteria for 
a material threat MCM priority review voucher. Remdesivir was approved 
on October 22, 2020, for use in adult and pediatric patients 12 years 
of age and older and weighing at least 40 kilograms (about 88 pounds) 
for the treatment of COVID-19 requiring hospitalization.
    For further information about the material threat MCM Priority 
Review Voucher Program and for a link to the full text of section 565A 
of the FD&C Act, go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation. For further information about VEKLURY, go 
to the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: April 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09233 Filed 4-28-22; 8:45 am]
BILLING CODE 4164-01-P


