Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 61600 [2023-19289]
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Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices
meeting to take place using an online
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interest of allowing greater transparency
and opportunities for public
participation, in addition to
convenience for advisory committee
members, speakers, and guest speakers.
No participant will be prejudiced by
this waiver, and that the ends of justice
will be served by allowing for this
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committee meeting procedures.
Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19284 Filed 9–6–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2607]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
Biopharmaceuticals, Inc., meets the
criteria for a priority review voucher.
SOHONOS (palovarotene) capsules are
indicated for reduction in volume of
new heterotopic ossification in adults
and pediatric patients (aged 8 years and
older for females and 10 years and older
for males) with fibrodysplasia ossificans
progressiva.
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/
Developing
ProductsforRareDiseasesConditions/
RarePediatricDisease
PriorityVoucherProgram/default.htm.
For further information about
SOHONOS (palovarotene), go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19289 Filed 9–6–23; 8:45 am]
BILLING CODE 4164–01–P
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)
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 SOHONOS
(palovarotene), manufactured by Ipsen
Biopharmaceuticals, Inc., meets the
criteria for 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.
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 SOHONOS (palovarotene),
approved on August 16, 2023, and
manufactured by Ipsen
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2023–D–3132, FDA–
2023–D–3133, and FDA–2023–D–3134]
Modernizing the Food and Drug
Administration’s Premarket
Notification Program; Draft Guidances
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of three
draft guidances entitled ‘‘Evidentiary
Expectations for 510(k) Implant
Devices,’’ ‘‘Recommendations for the
Use of Clinical Data in Premarket
Notification [510(k)] Submissions,’’ and
‘‘Best Practices for Selecting a Predicate
Device to Support a Premarket
Notification [510(k)] Submission.’’ FDA
is issuing these guidances to improve
the predictability, consistency, and
transparency of the 510(k) premarket
review process. The draft guidances are
not final nor are they for
implementation at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by December 6, 2023 to ensure that the
Agency considers your comment on this
SUMMARY:
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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:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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 Docket No. FDA–2023–D–
3132 for ‘‘Evidentiary Expectations for
510(k) Implant Devices,’’ Docket No.
FDA–2023–D–3133 for
‘‘Recommendations for the Use of
Clinical Data in Premarket Notification
[510(k)] Submissions,’’ or Docket No.
FDA–2023–D–3134 for ‘‘Best Practices
for Selecting a Predicate Device to
Support a Premarket Notification
[510(k)] Submission.’’ 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
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[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Page 61600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19289]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2607]
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 SOHONOS (palovarotene), manufactured by Ipsen Biopharmaceuticals,
Inc., meets the criteria for 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 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 SOHONOS (palovarotene), approved on August 16,
2023, and manufactured by Ipsen Biopharmaceuticals, Inc., meets the
criteria for a priority review voucher. SOHONOS (palovarotene) capsules
are indicated for reduction in volume of new heterotopic ossification
in adults and pediatric patients (aged 8 years and older for females
and 10 years and older for males) with fibrodysplasia ossificans
progressiva.
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 SOHONOS (palovarotene), go to the ``Drugs@FDA''
website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19289 Filed 9-6-23; 8:45 am]
BILLING CODE 4164-01-P
