Document ID: FDA-2019-N-0895-0008
Agency: fda
Document Type: Notice
Title: Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure  Priority Review Voucher
Posted Date: 2022-08-29T04:00Z

[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Page 52790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18523]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Notice of Approval of Product Under Voucher: Material Threat 
Medical Countermeasure Priority Review Voucher

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
approval of a product redeeming a priority review voucher. The Federal 
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century 
Cures Act, authorizes FDA to award priority review vouchers to sponsors 
of a material threat medical countermeasure application that meets 
certain criteria upon approval of such application. FDA is required to 
publish notice of the issuance of priority review vouchers as well as 
the approval of products redeeming a priority review voucher. FDA has 
determined that the application for MOUNJARO (tirzepatide) injection, 
approved May 13, 2022, meets the redemption criteria.

FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8515 
(this is not a toll-free number), email: [email protected].

SUPPLEMENTARY INFORMATION: Under section 565A of the FD&C Act (21 
U.S.C. 360bbb-4a), which was added by section 3086 of the 21st Century 
Cures Act (Pub. L. 114-255), FDA will report the issuance of material 
threat medical countermeasure priority review vouchers and the approval 
of products for which a voucher was redeemed. FDA has determined that 
the application for MOUNJARO (tirzepatide) injection, approved May 13, 
2022, meets the redemption criteria.
    For further information about the Material Threat Medical 
Countermeasure 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/21st-century-cures-act-mcm-related-cures-provisions. For 
further information about MOUNJARO (tirzepatide) injection, go to the 
``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: August 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18523 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P