Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product, 54154 [2019-21984]

Download as PDF 54154 Federal Register / Vol. 84, No. 196 / Wednesday, October 9, 2019 / Notices authorized new optional title IV–E funding for time-limited (one year) prevention services for mental health/ substance abuse and in-home parent skill-based programs for: (1) A child who is a candidate for foster care (as defined in section 475(13) of the Act), (2) pregnant/parenting foster youth, and (3) the parents/kin caregivers of those children and youth (sections 471(e), 474(a)(6), and 475(13) of the Act). Title IV–E prevention services must be rated as promising, supported, or wellsupported in accordance with HHS criteria and be approved by HHS (section 471(e)(4)(C) of the Act) as part of the title IV–E Prevention Services Clearinghouse (section 476(d)(2) of the Act). A state or tribal title IV–E agency electing to participate in the program must submit a 5-year title IV–E prevention program plan that meets the statutory requirements. (See Program Instructions ACYF–CB–PI–18–09 and ACYF–CB–PI–18–10 for more information.) The FFPSA also amended Section 474(a)(7) of the Act to reimburse state and tribal IV–E agencies for a portion of the costs of operating kinship navigator programs that meet certain criteria. To qualify for funding under the title IV– E Kinship Navigator Program, the program must meet the requirements of a kinship navigator program described in section 427(a)(1) of the Act. The Kinship Navigator Program must also meet practice criteria of promising, supported, or well-supported in accordance with HHS criteria and be approved by HHS (section 471(e)(4)(C) of the Act). To begin participation in the title IV–E Kinship Navigator Program, a title IV–E agency must submit an attachment to its title IV–E plan that specifies the kinship navigator model it has chosen to implement and, the date on which the provision of program services began or will begin, and that provides an assurance that the model meets the requirements of section 427(a)(1) of the Act, as well as a brief narrative describing how the program will be operated. (Please see Program Instruction ACYF–CB–PI–18–11 for additional information.) Respondents: State and tribal title IV– E agencies. ANNUAL BURDEN ESTIMATES Total Number of Respondents Instrument Title IV–E Prevention Services Plan ................................................................ Attachment to Title IV–E plan for Kinship Navigator Program ........................ Estimated Total Annual Burden Hours: 195. Authority: Title IV–E of the Social Security Act as amended by Public Law 115– 123 enacted February 9, 2018. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–22072 Filed 10–8–19; 8:45 am] BILLING CODE 4184–25–P 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. 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 khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:13 Oct 08, 2019 Jkt 250001 30 45 (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, PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Number of Responses Per Respondent Average Burden Hours Per Response Annual Burden Hours 5 1 150 45 1 1 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-policyframework/mcm-relatedcounterterrorism-legislation. For further information about JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating), go to the Center for Biologics Evaluation and Research Approved Vaccine Products website at https://www.fda.gov/vaccines-bloodbiologics/vaccines/approved-vaccineproducts. 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 E:\FR\FM\09OCN1.SGM 09OCN1

Agencies

[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