Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
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Issuing agencies
Abstract
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. COMIRNATY (COVID-19 Vaccine, mRNA) was approved on August 23, 2020, and a license was issued to BioNTech Manufacturing GmbH. FDA has determined that COMIRNATY (COVID-19 Vaccine, mRNA) meets the criteria for a material threat MCM priority review voucher, which has been issued to BioNTech Manufacturing GmbH.
Full Text
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<title>Federal Register, Volume 87 Issue 33 (Thursday, February 17, 2022)</title>
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[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Page 9064]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03426]
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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.
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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. COMIRNATY (COVID-19 Vaccine, mRNA) was
approved on August 23, 2020, and a license was issued to BioNTech
Manufacturing GmbH. FDA has determined that COMIRNATY (COVID-19
Vaccine, mRNA) meets the criteria for a material threat MCM priority
review voucher, which has been issued to BioNTech Manufacturing GmbH.
FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
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
COMIRNATY (COVID-19 Vaccine, mRNA) meets the criteria for a material
threat MCM priority review voucher, which has been issued to BioNTech
Manufacturing GmbH. COMIRNATY is indicated for active immunization to
prevent coronavirus disease 2019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years
of age and older.
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 <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation</a>. For further information about COMIRNATY
(COVID-19 Vaccine, mRNA) go to the Center for Biologics Evaluation and
Research Approved Vaccine Products website at <a href="https://www.fda.gov/vaccines-blood-biologics/vaccines/approved-vaccine-products">https://www.fda.gov/vaccines-blood-biologics/vaccines/approved-vaccine-products</a>.
Dated: February 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03426 Filed 2-16-22; 8:45 am]
BILLING CODE 4164-01-P
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