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. 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.
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<title>Federal Register, Volume 86 Issue 131 (Tuesday, July 13, 2021)</title>
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[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Page 36752]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14779]
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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, Health and Human Services (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 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 <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 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 <a href="https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products">https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products</a>.
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
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