Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 54219 [2021-21311]
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Federal Register / Vol. 86, No. 187 / Thursday, September 30, 2021 / Notices
wire transfer, check, or online
payments.
As noted in section II, if a sponsor
uses a rare pediatric disease priority
review voucher for a human drug
application, the sponsor would incur
the rare pediatric disease priority review
voucher fee in addition to any PDUFA
fee that is required for the application.
The sponsor would need to follow
FDA’s normal procedures for timely
payment of the PDUFA fee for the
human drug application.
Payment must be made in U.S.
currency by electronic check, check,
bank draft, wire transfer, credit card, or
U.S. postal money order payable to the
order of the Food and Drug
Administration. The preferred payment
method is online using electronic check
(Automated Clearing House (ACH) also
known as eCheck). Secure electronic
payments can be submitted using the
User Fees Payment Portal at https://
userfees.fda.gov/pay (Note: Only full
payments are accepted. No partial
payments can be made online). Once
you search for your invoice, select ‘‘Pay
Now’’ to be redirected to Pay.gov. Note
that electronic payment options are
based on the balance due. Payment by
credit card is available for balances that
are less than $25,000. If the balance
exceeds this amount, only the ACH
option is available. Payments must be
made using U.S bank accounts as well
as U.S. credit cards.
If paying by paper check the invoice
number should be included on the
check, followed by the words ‘‘Rare
Pediatric Disease Priority Review.’’ All
paper checks must be in U.S. currency
from a U.S. bank made payable and
mailed to: Food and Drug
Administration, P.O. Box 979107, St.
Louis, MO 63197–9000.
If checks are sent by a courier that
requests a street address, the courier can
deliver the checks to: U.S. Bank,
Attention: Government Lockbox 979107,
1005 Convention Plaza, St. Louis, MO
63101. (Note: This U.S. Bank address is
for courier delivery only. If you have
any questions concerning courier
delivery, contact the U.S. Bank at 314–
418–4013. This telephone number is
only for questions about courier
delivery). The FDA post office box
number (P.O. Box 979107) must be
written on the check. If needed, FDA’s
tax identification number is 53–
0196965.
If paying by wire transfer, please
reference your invoice number when
completing your transfer. The
originating financial institution may
charge a wire transfer fee. If the
financial institution charges a wire
transfer fee, it is required to add that
VerDate Sep<11>2014
18:15 Sep 29, 2021
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amount to the payment to ensure that
the invoice is paid in full. The account
information is as follows: U.S. Dept. of
the Treasury, TREAS NYC, 33 Liberty
St., New York, NY 10045, Account
Number: 75060099, Routing Number:
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V. Reference
The following reference is on display
at the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, 240–402–7500, and is
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; it is not
available electronically at https://
www.regulations.gov as this reference is
copyright protected. FDA has verified
the website address, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. Ridley, D.B., H.G. Grabowski, and J.L. Moe,
‘‘Developing Drugs for Developing
Countries,’’ Health Affairs, vol. 25, no. 2,
pp. 313–324, 2006, available at: https://
www.healthaffairs.org/doi/full/10.1377/
hlthaff.25.2.313.
Dated: September 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21329 Filed 9–29–21; 8:45 am]
BILLING CODE 4164–01–P
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:
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)
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 RETHYMIC (allogeneic
processed thymus tissue-agdc),
manufactured by Enzyvant
Therapeutics, GmbH, meets the criteria
for a priority review voucher.
Frm 00071
Fmt 4703
FOR FURTHER INFORMATION CONTACT:
Myrna Hanna, 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: 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), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that RETHYMIC (allogeneic processed
thymus tissue-agdc), manufactured by
Enzyvant Therapeutics, GmbH, meets
the criteria for a priority review
voucher. RETHYMIC (allogeneic
processed thymus tissue-agdc) is
indicated for immune reconstitution in
pediatric patients with congenital
athymia.
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/industry/
developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For
further information about RETHYMIC
(allogeneic processed thymus tissueagdc), go to the Center for Biologics
Evaluation and Research Cellular and
Gene Therapy Products website at
https://www.fda.gov/vaccines-bloodbiologics/cellular-gene-therapyproducts/approved-cellular-and-genetherapy-products.
Dated: September 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21311 Filed 9–29–21; 8:45 am]
BILLING CODE 4164–01–P
Notice.
SUMMARY:
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54219
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–2307]
Real-World Data: Assessing Electronic
Health Records and Medical Claims
Data To Support Regulatory DecisionMaking for Drug and Biological
Products; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice of availability.
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]]>Agencies
[Federal Register Volume 86, Number 187 (Thursday, September 30, 2021)]
[Notices]
[Page 54219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21311]
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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) 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 RETHYMIC (allogeneic processed thymus tissue-agdc), manufactured
by Enzyvant Therapeutics, GmbH, meets the criteria for a priority
review voucher.
FOR FURTHER INFORMATION CONTACT: Myrna Hanna, 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: 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), FDA will award priority review vouchers to sponsors of approved
rare pediatric disease product applications that meet certain criteria.
FDA has determined that RETHYMIC (allogeneic processed thymus tissue-
agdc), manufactured by Enzyvant Therapeutics, GmbH, meets the criteria
for a priority review voucher. RETHYMIC (allogeneic processed thymus
tissue-agdc) is indicated for immune reconstitution in pediatric
patients with congenital athymia.
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/industry/developing-products-rare-diseases-conditions/rare-pediatric-disease-rpd-designation-and-voucher-programs. For further information about
RETHYMIC (allogeneic processed thymus tissue-agdc), go to the Center
for Biologics Evaluation and Research Cellular and Gene Therapy
Products website at https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.
Dated: September 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21311 Filed 9-29-21; 8:45 am]
BILLING CODE 4164-01-P
