Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 3935 [2020-01059]

Download as PDF 3935 Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Total responses (2016–2018) Average burden per response Total hours (2016–2018) Average annual burden hours 60.24; revision of regulatory review period determinations ............................... 60.30; due diligence petitions .................. 60.40; due diligence hearings .................. 12 1 1 1.333 1 1 16 3 1 100 50 10 1,600 150 10 533.33 50 3.3 Total .................................................. ........................ ........................ ........................ ........................ ........................ 586.63 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection reflects a small increase (+7 responses) associated with submissions received under § 60.24 in previous years. Dated: January 16, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–01084 Filed 1–22–20; 8:45 am] BILLING CODE 4164–01–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 VYONDYS 53 (golodirsen), manufactured by Sarepta Therapeutics, Inc., 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 SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES Number of responses per respondent Number of respondents 21 CFR part 60—Patent term restoration VerDate Sep<11>2014 17:13 Jan 22, 2020 Jkt 250001 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 VYONDYS 53 (golodirsen), manufactured by Sarepta Therapeutics, Inc., meets the criteria for a priority review voucher. VYONDYS 53 (golodirsen) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. 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/ DevelopingProductsforRare DiseasesConditions/RarePediatric DiseasePriorityVoucherProgram/ default.htm. For further information about VYONDYS (golodirsen), go to the ‘‘Drugs@FDA’’ website at https:// www.accessdata.fda.gov/scripts/cder/ daf/. Dated: January 16, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–01059 Filed 1–22–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Sickle Cell Disease Treatment Demonstration Regional Collaborative Program, OMB No. 0906–xxxx–New Health Resources and Services Administration (HRSA), Department of Health and Human Services. AGENCY: ACTION: PO 00000 Notice. Frm 00045 Fmt 4703 Sfmt 4703 In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than March 23, 2020. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Sickle Cell Disease Treatment Demonstration Regional Collaborative Program. OMB No.: 0906–xxxx–New. Abstract: The Sickle Cell Disease Treatment Demonstration Regional Collaborative Program (SCDTDRCP) was reauthorized and amended in 2018 by the Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act (Pub. L. 115–327), 42 U.S.C. 300b– 5. The purpose of the proposed data collection is to monitor the progress of the SCDTDRCP in improving health outcomes in individuals living with sickle cell disease. The goals of the program are to improve health outcomes in individuals with sickle cell disease; reduce morbidity and mortality caused by SUMMARY: E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Page 3935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01059]


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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 VYONDYS 53 (golodirsen), manufactured by Sarepta Therapeutics, 
Inc., 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 
VYONDYS 53 (golodirsen), manufactured by Sarepta Therapeutics, Inc., 
meets the criteria for a priority review voucher. VYONDYS 53 
(golodirsen) is indicated for the treatment of Duchenne muscular 
dystrophy (DMD) in patients who have a confirmed mutation of the DMD 
gene that is amenable to exon 53 skipping.
    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 VYONDYS (golodirsen), go to the ``[email protected]'' website 
at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01059 Filed 1-22-20; 8:45 am]
BILLING CODE 4164-01-P

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