Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor), 2006 [2025-00341]
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2006
Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Notices
A panel of evaluators will be
assembled and utilize a standardized
rubric to score the submitted proposals
and identify hospitals with the highest
scores. Results will be used to guide the
future of the Medicare and Medicaid
programs and to inform reform
initiatives. Form Number: CMS–10069
(OMB control number: 0938–0880);
Frequency: Once; Affected Public:
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 30; Total Annual
Responses: 30; Total Annual Hours:
2,400. (For policy questions regarding
this collection contact Alexis Lilly at
410–786–3501).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2025–00399 Filed 1–8–25; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Amendment of the Statement of
Organizations, Functions and
Delegation of Authority
Office of Refugee Resettlement,
Administration for Children and
Families, Department of Health and
Human Services.
ACTION: Notice of amendment.
AGENCY:
The Administration for
Children and Families (ACF) is
amending the Statement of
Organization, Functions and Delegation
of Authority (‘‘Statement’’) issued in the
Federal Register on April 28, 2009. The
Statement delegated specific provisions
of the William Wilberforce Trafficking
Victims Protection Reauthorization Act
of 2008, Public Law 110–457, section
235 from the Assistant Secretary for
Children and Families to the Director of
the Office of Refugee Resettlement. This
amendment modifies the Statement to
authorize the Director of the Office of
Refugee Resettlement to redelegate the
listed authorities contained within the
Statement.
DATES: This amendment of the April 28,
2009, Statement of Organization,
Functions and Delegation of Authority
is effective on date of signature.
FOR FURTHER INFORMATION CONTACT:
Toby Biswas, Director of Policy,
Division of Unaccompanied Children
Policy, Unaccompanied Children
Bureau, Office of Refugee Resettlement,
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:28 Jan 08, 2025
Jkt 265001
Administration for Children and
Families, Department of Health and
Human Services, Washington, DC, (202)
205–4440 or UCPolicyRegulatoryAffairs@acf.hhs.gov.
SUPPLEMENTARY INFORMATION:
The first paragraph of the Statement
of Organization, Functions and
Delegation of Authority issued in the
Federal Register on April 28, 2009 (74
FR 19232) currently reads as follows:
‘‘Notice is hereby given that I delegate
to the Director of the Office of Refugee
Resettlement the following authority
delegated to the Assistant Secretary for
Children and Families by the Secretary
of the Department of Health and Human
Services (HHS) under the William
Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008,
Public Law 110–457, section 235.’’
This paragraph is amended to read as
follows:
‘‘Notice is hereby given that I have
delegated to the Director of the Office of
Refugee Resettlement, with authority to
re-delegate, the following authority
delegated to the Assistant Secretary for
Children and Families by the Secretary
of the Department of Health and Human
Services (HHS) under the William
Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008,
Public Law 110–457, section 235.’’
The intention of this amendment is to
provide notice to the public of the
Assistant Secretary’s delegation of
authority provided in subsequent
portions of the notice, as well as the
authority to redelegate the listed
authorities.
All other provisions of the Statement
of Organization, Functions and
Delegation of Authority issued in the
Federal Register on April 28, 2009 (74
FR 19232) will remain unchanged.
Meg Sullivan,
Principal Deputy Assistant Secretary for the
Administration for Children and Families,
performing the delegable duties of the
Assistant Secretary for Children and Families.
[FR Doc. 2025–00262 Filed 1–8–25; 8:45 am]
BILLING CODE 4184–45–P
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; ALYFTREK
(vanzacaftor, tezacaftor, and
deutivacaftor)
AGENCY:
ACTION:
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) 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 the
application for ALYFTREK (vanzacaftor,
tezacaftor, and deutivacaftor), approved
December 20, 2024, meets the criteria
for redeeming a priority review voucher.
SUMMARY:
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.
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),
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
application for ALYFTREK (vanzacaftor,
tezacaftor, and deutivacaftor) tablets
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/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about ALYFTREK
(vanzacaftor, tezacaftor, and
deutivacaftor), go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: January 3, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025–00341 Filed 1–8–25; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
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[Federal Register Volume 90, Number 6 (Friday, January 10, 2025)]
[Notices]
[Page 2006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00341]
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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; ALYFTREK (vanzacaftor, tezacaftor, and
deutivacaftor)
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) 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 the application for ALYFTREK
(vanzacaftor, tezacaftor, and deutivacaftor), approved December 20,
2024, 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.
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), 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 application for ALYFTREK (vanzacaftor, tezacaftor,
and deutivacaftor) tablets 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 ALYFTREK (vanzacaftor, tezacaftor, and
deutivacaftor), go to the ``Drugs@FDA'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: January 3, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-00341 Filed 1-8-25; 8:45 am]
BILLING CODE 4164-01-P
