Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 78859 [2020-26801]

Download as PDF Federal Register / Vol. 85, No. 235 / Monday, December 7, 2020 / Notices redelegations, provided they are consistent with this reorganization. IV. Funds, Personnel, and Equipment. Transfer of organizations and functions affected by this reorganization shall be accompanied in each instance by direct and support funds, positions, personnel, records, equipment, supplies, and other resources. This reorganization will be effective upon date of signature. Authority: 42 U.S.C. 652 Dated: December 1, 2020. Megan E. Steel, Office of the Executive Secretariat, Administration for Children and Families. [FR Doc. 2020–26778 Filed 12–4–20; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0026] Issuance of Priority Review Voucher; Rare Pediatric Disease 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 rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that DANYELZA (naxitamab-gqgk) manufactured by YmAbs Therapeutics, Inc., (Cato Research LLC., US Agent) meets the criteria for a priority review voucher. FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–4061, FAX: 301–796–9856, email: althea.cuff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will award priority review vouchers to sponsors of approved rare pediatric disease product khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:32 Dec 04, 2020 Jkt 253001 applications that meet certain criteria. FDA has determined that DANYELZA (naxitamab-gqgk) manufactured by YmAbs Therapeutics, Inc., (Cato Research LLC., US Agent), meets the criteria for a priority review voucher. DANYELZA (naxitamab-gqgk) indicated, in combination with granulocyte-macrophage colonystimulating factor (GM–CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/ DevelopingProductsforRareDiseases Conditions/RarePediatricDiseasePriority VoucherProgram/default.htm. For further information about DANYELZA (naxitamab) go to the ‘‘Drugs@FDA’’ website at https:// www.accessdata.fda.gov/scripts/cder/ daf/. Dated: December 1, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–26801 Filed 12–4–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–5900] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Endorser Status and Explicitness of Payment in Directto-Consumer Promotion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by January 6, 2021. ADDRESSES: To ensure that comments on the information collection are received, SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 78859 OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comment’’ or by using the search function. The title of this information collection is ‘‘Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. For copies of the questionnaires contact: Office of Prescription Drug Promotion (OPDP) Research Team, DTCresearch@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion OMB Control Number 0910—NEW I. Background Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. The Office of Prescription Drug Promotion’s (OPDP) mission is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. OPDP’s research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission. Our research focuses in particular on three main topic areas: Advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and disease and E:\FR\FM\07DEN1.SGM 07DEN1

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[Federal Register Volume 85, Number 235 (Monday, December 7, 2020)]
[Notices]
[Page 78859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26801]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0026]


Issuance of Priority Review Voucher; Rare Pediatric Disease 
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 rare 
pediatric disease product application. The Federal Food, Drug, and 
Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration 
Safety and Innovation Act (FDASIA), authorizes FDA to award priority 
review vouchers to sponsors of approved rare pediatric disease product 
applications that meet certain criteria. FDA is required to publish 
notice of the award of the priority review voucher. FDA has determined 
that DANYELZA (naxitamab-gqgk) manufactured by Y-mAbs Therapeutics, 
Inc., (Cato Research LLC., US Agent) meets the criteria for a priority 
review voucher.

FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, FAX: 301-
796-9856, email: [email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority 
review voucher to the sponsor of an approved rare pediatric disease 
product application. Under section 529 of the FD&C Act (21 U.S.C. 
360ff), which was added by FDASIA, FDA will award priority review 
vouchers to sponsors of approved rare pediatric disease product 
applications that meet certain criteria. FDA has determined that 
DANYELZA (naxitamab-gqgk) manufactured by Y-mAbs Therapeutics, Inc., 
(Cato Research LLC., US Agent), meets the criteria for a priority 
review voucher.
    DANYELZA (naxitamab-gqgk) indicated, in combination with 
granulocyte-macrophage colony-stimulating factor (GM-CSF), for the 
treatment of pediatric patients 1 year of age and older and adult 
patients with relapsed or refractory high-risk neuroblastoma in the 
bone or bone marrow who have demonstrated a partial response, minor 
response, or stable disease to prior therapy.
    For further information about the Rare Pediatric Disease Priority 
Review Voucher Program and for a link to the full text of section 529 
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further 
information about DANYELZA (naxitamab) go to the ``[email protected]'' website 
at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: December 1, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26801 Filed 12-4-20; 8:45 am]
BILLING CODE 4164-01-P

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