Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher, 4314-4315 [2024-01156]
Download as PDF
<![CDATA[
4314
Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices
information collection. We further
estimate the total time needed to
prepare complete applications for
diagnostic radiopharmaceuticals as
approximately 6,000 hours. This
information collection does not impose
any additional reporting burden for
safety and effectiveness information on
diagnostic radiopharmaceuticals beyond
the estimated burden of 2,000 hours,
because safety and effectiveness
information is already required in
§ 314.50 and has been approved under
OMB control number 0910–0001. In
fact, clarification of our criteria for the
evaluation of diagnostic
radiopharmaceuticals in this
information collection is intended to
streamline overall information
collection burdens, particularly for
diagnostic radiopharmaceuticals that
may have well-established, low-risk
safety profiles by enabling
manufacturers to tailor information
further estimate that the total time
needed to prepare the portions of the
application that would be affected by
this information collection as 750 hours.
As previously stated, this information
collection does not impose any
additional reporting burden for safety
and effectiveness information on
diagnostic radiopharmaceuticals beyond
the estimated burden of 750 hours
because safety and effectiveness
information is already required in
§ 314.50 and has been approved under
OMB control number 0910–0001.
submissions and avoid unnecessary
clinical trials.
In table 1, row 2, we estimate the
annual reporting burden for preparing
the safety and effectiveness sections of
a supplement to an approved
application. This estimate does not
include the time needed to conduct
studies and clinical trials or other
research from which the reported
information is obtained.
Based on past submissions of human
drug applications, new indication
supplements for diagnostic
radiopharmaceuticals, or both, we
estimate that one submission will be
received annually. We estimate the total
time needed to prepare complete
applications for supplements to new
applications for diagnostic
radiopharmaceuticals as approximately
between 500 and 1,000 hours. We
calculated the median of this estimate to
arrive at approximately 750 hours. We
In the Federal Register of October 12,
2023 (88 FR 70667), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR NDAS AND SUPPLEMENTS TO APPROVED NDAS FOR
DIAGNOSTIC RADIOPHARMACEUTICALS1
Average
burden per
response
Total annual
responses
Total hours
NDAs (§§ 315.4, 315.5, and 315.6) ...................................
Supplements to Approved NDAs (§§ 315.4, 315.5, and
315.6) .............................................................................
3
1
3
2,000
6,000
1
1
1
750
750
Total ............................................................................
........................
..........................
........................
........................
6,750
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Food and Drug Administration
potassium, and sodium oxybates),
approved July 21, 2020, meets the
criteria for redeeming a priority review
voucher.
[Docket No. FDA–2018–N–1262]
FOR FURTHER INFORMATION CONTACT:
Our estimated burden for the
information collection reflects an
overall decrease of 11 responses with a
corresponding decrease of 12,000
burden hours. We attribute this
adjustment to a decrease in the number
of submissions for NDAs for diagnostic
radiopharmaceuticals and new
indication supplements for diagnostic
radiopharmaceuticals we received over
the past few years.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
ACTION:
[FR Doc. 2024–01237 Filed 1–22–24; 8:45 am]
BILLING CODE 4164–01–P
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Manufacturers’ activity (21 CFR section)
VerDate Sep<11>2014
17:41 Jan 22, 2024
Jkt 262001
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher
AGENCY:
Food and Drug Administration,
HHS.
Notice.
Frm 00041
Fmt 4703
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),
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 XYWAV
(calcium, magnesium, potassium, and
sodium oxybates) meets the redemption
criteria.
SUPPLEMENTARY INFORMATION:
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) 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
XYWAV (calcium, magnesium,
SUMMARY:
PO 00000
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.
Sfmt 4703
E:\FR\FM\23JAN1.SGM
23JAN1
Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices
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/RarePediatric
DiseasePriorityVoucherProgram/
default.htm. For further information
about XYWAV (calcium, magnesium,
potassium, and sodium oxybates), go to
the ‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01156 Filed 1–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5656]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; State Enforcement
Notifications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing an opportunity for
public comment on the proposed
collection of certain information by the
Agency. Under the Paperwork
Reduction Act of 1995 (PRA), Federal
agencies are required to publish notice
in the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on reporting
requirements contained in existing FDA
regulations governing State enforcement
notifications.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
March 25, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
March 25, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:41 Jan 22, 2024
Jkt 262001
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 the Docket No. FDA–
2023–N–5656 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; State
Enforcement Notifications.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
4315
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
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Pages 4314-4315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01156]
-----------------------------------------------------------------------
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) 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 XYWAV (calcium, magnesium, potassium,
and sodium oxybates), approved July 21, 2020, 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), 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 XYWAV (calcium, magnesium, potassium, and sodium
oxybates) meets the redemption criteria.
[[Page 4315]]
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 XYWAV (calcium, magnesium, potassium, and sodium
oxybates), go to the ``Drugs@FDA'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01156 Filed 1-22-24; 8:45 am]
BILLING CODE 4164-01-P
