Document ID: FDA-2019-N-0895-0003
Agency: fda
Document Type: Notice
Title: Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
Posted Date: 2021-07-13T04:00Z

[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Page 36752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14779]

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

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, Health and Human Services (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 STRATAGRAFT 
(allogeneic cultured keratinocytes and dermal fibroblasts in murine 
collagen--dsat), manufactured by Stratatech, a Mallinckrodt Company, 
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 
STRATAGRAFT (allogeneic cultured keratinocytes and dermal fibroblasts 
in murine collagen--dsat), manufactured by Stratatech, a Mallinckrodt 
Company, meets the criteria for a material threat MCM priority review 
voucher. STRATAGRAFT is indicated for the treatment of adults with 
thermal burns containing intact dermal elements for which surgical 
intervention is clinically indicated (deep partial-thickness burns).
    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 STRATAGRAFT 
(allogeneic cultured keratinocytes and dermal fibroblasts in murine 
collagen--dsat), go to the Center for Biologics Evaluation and Research 
Approved Cellular and Gene Therapy Products website at https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.

    Dated: July 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14779 Filed 7-12-21; 8:45 am]
BILLING CODE 4164-01-P