Document ID: FDA-2019-N-0895-0001
Agency: fda
Document Type: Notice
Title: Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
Posted Date: 2019-04-01T04:00Z

[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Page 12262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06145]

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

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. On July 13, 2018, FDA determined that 
TPOXX (tecovirimat), manufactured by SIGA Technologies, Inc., meets the 
criteria for a priority review voucher.

FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Office of 
Counterterrorism and Emerging Threats, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 301-796-8510.

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a 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, FDA will award priority 
review vouchers to sponsors of approved material threat MCM product 
applications that meet certain criteria. FDA has determined that TPOXX 
(tecovirimat), manufactured by SIGA Technologies, Inc., meets the 
criteria for a priority review voucher. TPOXX (tecovirimat) is 
indicated to treat human smallpox disease in adults and pediatric 
patients weighing at least 13 kilograms.
    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/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm566498.htm#prv. For further 
information about TPOXX (tecovirimat), go to the ``[email protected]'' website 
at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06145 Filed 3-29-19; 8:45 am]
 BILLING CODE 4164-01-P