Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Withdrawal, 55619 [2021-21823]
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Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices
II. Paperwork Reduction Act of 1995
While this guidance contains no
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www.regulations.gov.
Dated: September 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21689 Filed 10–5–21; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product;
Withdrawal
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice; withdrawal.
AGENCY:
The Food and Drug
Administration (FDA) is withdrawing
the notice that published in the Federal
Register of September 30, 2021, that
announced the issuance of a priority
review voucher to the sponsor of a rare
pediatric disease product application.
The Federal Register notice was
published in error and is being
withdrawn.
FOR FURTHER INFORMATION CONTACT:
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 30, 2021
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
20:38 Oct 05, 2021
Dated: October 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21823 Filed 10–5–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1402]
Biomarkers and Surrogate Endpoints
in Clinical Studies To Support
Effectiveness of New Animal Drugs;
Guidance for Industry; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry (GFI) #267
entitled ‘‘Biomarkers and Surrogate
Endpoints in Clinical Studies to
Support Effectiveness of New Animal
Drugs.’’ The guidance describes FDA’s
current thinking with respect to
incorporating biomarkers and surrogate
endpoints into proposed clinical
investigational protocols and
applications for new animal drugs
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: The announcement of the
guidance is published in the Federal
Register on October 6, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
(86 FR 54219) in FR Doc. 2021–21311,
FDA announced the issuance of a
priority review voucher to the sponsor
of a rare pediatric disease product
application for RETHYMIC (allogeneic
processed thymus tissue-agdc),
manufactured by Enzyvant
Therapeutics, GmbH. The Federal
Register notice was published in error
and is being withdrawn.
Jkt 256001
Electronic Submissions
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55619
comment does not include any
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E:\FR\FM\06OCN1.SGM
06OCN1
]]>Agencies
[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Page 55619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21823]
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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; Withdrawal
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing the
notice that published in the Federal Register of September 30, 2021,
that announced the issuance of a priority review voucher to the sponsor
of a rare pediatric disease product application. The Federal Register
notice was published in error and is being withdrawn.
FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 30,
2021 (86 FR 54219) in FR Doc. 2021-21311, FDA announced the issuance of
a priority review voucher to the sponsor of a rare pediatric disease
product application for RETHYMIC (allogeneic processed thymus tissue-
agdc), manufactured by Enzyvant Therapeutics, GmbH. The Federal
Register notice was published in error and is being withdrawn.
Dated: October 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21823 Filed 10-5-21; 8:45 am]
BILLING CODE 4164-01-P
