[Federal Register Volume 84, Number 196 (Wednesday, October 9, 2019)]
[Notices]
[Page 54154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21984]


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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. FDA has determined that JYNNEOS, 
(Smallpox and Monkeypox Vaccine, Live, Non-replicating), manufactured 
by Bavarian Nordic A/S, meets the criteria for a priority review 
voucher.

FOR FURTHER INFORMATION CONTACT: Shruti Modi, 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 
JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Non-replicating), 
manufactured by Bavarian Nordic A/S, meets the criteria for a material 
threat MCM priority review voucher because it is intended to prevent 
smallpox infection and meets the other criteria for a material threat 
MCM priority review voucher. JYNNEOS is indicated for prevention of 
smallpox and monkeypox disease in adults 18 years of age and older 
determined to be at high risk for smallpox or monkeypox infection.
    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 JYNNEOS 
(Smallpox and Monkeypox Vaccine, Live, Non-replicating), go to the 
Center for Biologics Evaluation and Research Approved Vaccine Products 
website at https://www.fda.gov/vaccines-blood-biologics/vaccines/approved-vaccine-products.

    Dated: October 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21984 Filed 10-8-19; 8:45 am]
BILLING CODE 4164-01-P


