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