Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher, 75052 [2022-26565]
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75052
Federal Register / Vol. 87, No. 234 / Wednesday, December 7, 2022 / Notices
Mary B. Jones,
ACF/OPRE Certifying Officer.
For further information about IMJUDO
(tremelimumab), approved October 23,
2022, go to the ‘‘Drugs@FDA’’ website at
https://www.accessdata.fda.gov/scripts/
cder/daf/.
[FR Doc. 2022–26542 Filed 12–6–22; 8:45 am]
BILLING CODE 4184–82–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2022–26565 Filed 12–6–22; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2018–N–1262]
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration,
HHS.
ACTION:
[Docket No. FDA–2022–D–2301]
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 IMJUDO
(tremelimumab), approved October 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.
SUMMARY:
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 IMJUDO
(tremelimumab), approved October 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.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK6VXHR33PROD with NOTICES
Food and Drug Administration
VerDate Sep<11>2014
19:54 Dec 06, 2022
Jkt 259001
Small Volume Parenteral Drug
Products and Pharmacy Bulk
Packages for Parenteral Nutrition:
Aluminum Content and Labeling
Recommendations; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Small
Volume Parenteral Drug Products and
Pharmacy Bulk Packages for Parenteral
Nutrition: Aluminum Content and
Labeling Recommendations.’’ This draft
guidance is intended to clarify the key
factors in determining the appropriate
aluminum content in a small volume
parenteral (SVP) drug product and/or a
pharmacy bulk package (PBP) intended
as a component of parenteral nutrition
(PN) and provide FDA’s
recommendations regarding the
concentration of aluminum in SVP drug
products and PBPs for PN. Additionally,
this guidance is intended to assist
applicants in determining the
appropriate content and placement of
information on aluminum in SVP and
PBP human prescription drug product
labeling.
DATES: Submit either electronic or
written comments on the draft guidance
by February 6, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–D–2301 for ‘‘Small Volume
Parenteral Drug Products and Pharmacy
Bulk Packages for Parenteral Nutrition:
Aluminum Content and Labeling
Recommendations.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
E:\FR\FM\07DEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 234 (Wednesday, December 7, 2022)]
[Notices]
[Page 75052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26565]
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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 IMJUDO (tremelimumab),
approved October 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 IMJUDO (tremelimumab), approved
October 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 IMJUDO (tremelimumab), approved October 23, 2022, go
to the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: December 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26565 Filed 12-6-22; 8:45 am]
BILLING CODE 4164-01-P
