Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher, 76490 [2022-27138]

Download as PDF 76490 Federal Register / Vol. 87, No. 239 / Wednesday, December 14, 2022 / Notices ingredient to the approved inert list is a prerequisite to approval of applications for registration of specific pesticide formulations that contain the inert ingredient. Approval of a registration application does incorporate risk and considers risks resulting from the formulation of the pesticide product including its inert ingredients. As of the date of this notice, EPA is removing the twelve chemicals listed here from the current list of inert ingredients approved for use in pesticide products. These twelve chemicals are for nonfood use only and there are no food residue considerations related to this action. Authority: 7 U.S.C. 136 et seq. Dated: December 8, 2022. Michal Freedhoff, Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2022–27085 Filed 12–13–22; 8:45 am] FEDERAL RESERVE SYSTEM lotter on DSK11XQN23PROD with NOTICES1 Formations of, Acquisitions by, and Mergers of Bank Holding Companies Jkt 259001 [FR Doc. 2022–27139 Filed 12–13–22; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES disease priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that the supplemental application for TYVASO DPI (treprostinil), approved May 23, 2022, meets the redemption criteria. 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/RarePediatricDisease PriorityVoucherProgram/default.htm. For further information about TYVASO DPI (treprostinil), approved May 23, 2022, go to the ‘‘Drugs@FDA’’ website at https://www.accessdata.fda.gov/scripts/ cder/daf/. Dated: December 9, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–27138 Filed 12–13–22; 8:45 am] [Docket No. FDA–2018–N–1262] BILLING CODE 4164–01–P Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board’s Freedom of Information Office at https://www.federalreserve.gov/foia/ request.htm. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, 17:11 Dec 13, 2022 Board of Governors of the Federal Reserve System. Michele Taylor Fennell, Deputy Associate Secretary of the Board. Food and Drug Administration BILLING CODE 6560–50–P VerDate Sep<11>2014 Washington, DC 20551–0001, not later than January 13, 2023. A. Federal Reserve Bank of Atlanta (Erien O. Terry, Assistant Vice President) 1000 Peachtree Street NE, Atlanta, Georgia 30309; Comments can also be sent electronically to Applications.Comments@atl.frb.org: 1. Surety Financial Holdings, Inc., DeLand, Florida; to become a bank holding company by acquiring Surety Bank, DeLand, Florida. Food and Drug Administration, HHS. ACTION: [Docket No. FDA–2022–N–0521] Notice. The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. 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 issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that TYVASO DPI (treprostinil), approved May 23, 2022, meets the criteria for redeeming 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, email: Cathryn.Lee@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is announcing the approval of a product redeeming a rare pediatric disease priority review voucher. Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will report the issuance of rare pediatric SUMMARY: PO 00000 Frm 00039 Fmt 4703 Food and Drug Administration Sfmt 4703 David J. Kempema: Final Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring David J. Kempema for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Kempema was convicted of one felony count under Federal law which FDA has determined is for conduct relating to the importation into the United States of a drug or controlled substance. The factual basis supporting Mr. Kempema’s conviction is described in further detail below. Mr. Kempema was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of September 14, 2022 (30 days after receipt of the notice), Mr. Kempema had not responded. Mr. Kempema’s failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter. DATES: This order is applicable December 14, 2022. SUMMARY: E:\FR\FM\14DEN1.SGM 14DEN1

Agencies

[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Page 76490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27138]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1262]


Notice of Approval of Product Under Voucher: Rare Pediatric 
Disease Priority Review Voucher

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of approval of a product redeeming a priority review voucher. 
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 issuance of priority 
review vouchers as well as the approval of products redeeming a 
priority review voucher. FDA has determined that TYVASO DPI 
(treprostinil), approved May 23, 2022, meets the criteria for redeeming 
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, email: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the approval of a product 
redeeming a rare pediatric disease priority review voucher. Under 
section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by 
FDASIA, FDA will report the issuance of rare pediatric disease priority 
review vouchers and the approval of products for which a voucher was 
redeemed. FDA has determined that the supplemental application for 
TYVASO DPI (treprostinil), approved May 23, 2022, meets the redemption 
criteria.
    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 TYVASO DPI (treprostinil), approved May 23, 2022, go 
to the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: December 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27138 Filed 12-13-22; 8:45 am]
BILLING CODE 4164-01-P


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