Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 14125 [2021-05207]
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Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices
are no substantial changes to the forms,
only minor changes such as to reflect a
temporary change in the Federal
Financial Participation rate.
Respondents: State and tribal agencies
with approved title IV–E plans.
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Annual
number of
responses per
respondent
Average
burden hours
per response
Annual
burden hours
Form CB–496 ..................................................................................................
67
4
23
6,164
Estimated Total Annual Burden
Hours: 6,164.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 671(a)(6), 42 U.S.C.
671(a)(7), 42 U.S.C. 673(a)(8)(B), and 42
U.S.C. 674(a) and (b).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–05157 Filed 3–11–21; 8:45 am]
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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.
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
SUMMARY:
VerDate Sep<11>2014
17:04 Mar 11, 2021
Jkt 253001
award of the priority review voucher.
FDA has determined that NULIBRY
(fosdenopterin), manufactured by Origin
Biosciences, 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.
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 NULIBRY
(fosdenopterin), manufactured by Origin
Biosciences, Inc., meets the criteria for
a priority review voucher.
NULIBRY (fosdenopterin) is indicated
to reduce the risk of mortality in
patients with Molybdenum Cofactor
Deficiency Type A.
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 NULIBRY
(fosdenopterin), go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05207 Filed 3–11–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1440]
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Oncologic Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
SUMMARY:
The meeting will be held on
April 27, 2021, from 1 p.m. to 3:45 p.m.
Eastern Time, on April 28, 2021, from
9 a.m. to 3 p.m. Eastern Time, and on
April 29, 2021, from 9 a.m. to 5:30 p.m.
Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2020–N–1440.
The docket will close on April 26, 2021.
Submit either electronic or written
comments on this public meeting by
April 26, 2021. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 26,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
DATES:
E:\FR\FM\12MRN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 47 (Friday, March 12, 2021)]
[Notices]
[Page 14125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05207]
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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 NULIBRY (fosdenopterin), manufactured by Origin Biosciences, 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
NULIBRY (fosdenopterin), manufactured by Origin Biosciences, Inc.,
meets the criteria for a priority review voucher.
NULIBRY (fosdenopterin) is indicated to reduce the risk of
mortality in patients with Molybdenum Cofactor Deficiency Type A.
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 NULIBRY (fosdenopterin), go to the ``[email protected]''
website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05207 Filed 3-11-21; 8:45 am]
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