Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OJEMDA (tovorafenib), 42472 [2024-10583]

Download as PDF 42472 Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Notices ANNUAL BURDEN ESTIMATES Number of responses per respondent (total over request period) Number of respondents (total over request period) Instrument Average burden per response (in hours) Total/annual burden (in hours) Program director survey (Instrument 1) ........................................................... ERSEA lead staff survey (Instrument 2) ......................................................... Onsite coordination a ........................................................................................ Head Start parent/caregiver survey (Instrument 3) ......................................... Community partner survey (Instrument 4) ....................................................... ERSEA lead staff focus group guide (Instrument 5) ....................................... 60 60 60 600 180 24 1 1 1 1 1 1 0.17 0.75 1.5 0.5 0.25 1.5 10.2 45 90 300 45 36 Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 526.2 a There is no instrument associated with this activity. We will ask each program director to nominate a staff person who will help coordinate data collection activities. This line accounts for the time of the onsite coordinator. Authority: Head Start Act Section 640 [42 U.S.C. 9835]. Mary C. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2024–10578 Filed 5–14–24; 8:45 am] BILLING CODE 4184–22–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; OJEMDA (tovorafenib) 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) 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 OJEMDA (tovorafenib), approved on April 23, 2024, manufactured by Day One Biopharmaceuticals, Inc., meets the criteria for a priority review voucher. FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–1394. SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 19:12 May 14, 2024 Jkt 262001 application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that OJEMDA (tovorafenib), manufactured by Day One Biopharmaceuticals, Inc., meets the criteria for a priority review voucher. OJEMDA (tovorafenib) is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. 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/ RarePediatricDisease PriorityVoucherProgram/default.htm. For further information about OJEMDA (tovorafenib), go to the ‘‘Drugs@FDA’’ website at https://www.accessdata. fda.gov/scripts/cder/daf/. Dated: May 9, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–10583 Filed 5–14–24; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–2032] Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Cosmetic Export Certificate Application Process AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with export certificate applications for FDAregulated human food and cosmetic products. SUMMARY: Either electronic or written comments on the collection of information must be submitted by July 15, 2024. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 15, 2024. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered DATES: E:\FR\FM\15MYN1.SGM 15MYN1

Agencies

[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)]
[Notices]
[Page 42472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10583]


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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; OJEMDA (tovorafenib)

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) 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 OJEMDA (tovorafenib), approved on April 23, 2024, manufactured by 
Day One Biopharmaceuticals, Inc., meets the criteria for a priority 
review voucher.

FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1394.

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), FDA will award priority review vouchers to sponsors of approved 
rare pediatric disease product applications that meet certain criteria. 
FDA has determined that OJEMDA (tovorafenib), manufactured by Day One 
Biopharmaceuticals, Inc., meets the criteria for a priority review 
voucher. OJEMDA (tovorafenib) is indicated for the treatment of 
patients 6 months of age and older with relapsed or refractory 
pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or 
BRAF V600 mutation.
    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 OJEMDA (tovorafenib), go to the ``Drugs@FDA'' website 
at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: May 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10583 Filed 5-14-24; 8:45 am]
BILLING CODE 4164-01-P
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