Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc), 58165-58166 [2024-15695]
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58165
Federal Register / Vol. 89, No. 137 / Wednesday, July 17, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Child Support Portal
Registration (Office of Management
and Budget #: 0970–0370)
Office of Child Support
Services, Administration for Children
and Families, U.S. Department of Health
and Human Services.
ACTION: Request for Public Comments.
AGENCY:
The Office of Child Support
Services (OCSS), Administration for
Children and Families (ACF), is
requesting the federal Office of
Management and Budget (OMB)
approve the ‘‘Child Support Portal
Registration,’’ with minor revisions, for
an additional three years. The OCSS
Child Support Portal (‘‘Portal’’) contains
applications to help state child support
agencies administer their programs.
Authorized Portal users must register
with OCSS to access Portal applications
and provide OCSS with certain Portal
SUMMARY:
application preferences. The current
OMB approval expires on February 28,
2025.
DATES: Comments due September 16,
2024. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Identify all requests by the
title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The OCSS Division of
Federal Systems (DFS) maintains the
Portal, which contains various
applications through which authorized
users may view, update, upload, or
download information for child support
purposes. Authorized users must
register to access the Portal. The DFS
Portal team authenticates registrants and
then creates secure profiles for
authorized users for employers,
insurers, and financial institutions
based on information provided in the
Employer Services and Insurance Match
Debt Inquiry Portal Agreement and
Profile forms. Information provided in
the electronic National Medical Support
Notice (e-NMSN), the electronic
Incoming Withholding Order (e-IWO),
and Federally Assisted State
Transmitted (FAST) Levy Financial
Institution Profile form gives DFS the
necessary information to set up the
respective program user’s process and
capture preferences. The information
OCSS collects for the Portal registration
and profiles remains the same but they
underwent minor clarification revisions
and edits to update ‘‘Office of Child
Support Enforcement (OCSE)’’ to
‘‘Office of Child Support Services
(OCSS).’’
State child support agencies manage
and authenticate authorization for
individual users via the state proxy
server; therefore, a Portal Registration
form is not required. State users must,
however, provide DFS with their
respective Portal preferences.
Respondents: Employers, Financial
Institutions, Insurers, and State Child
Support Agencies.
ANNUAL BURDEN ESTIMATES
Total
annual
estimated
number of
respondents
Information collection instrument
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Portal Registration Screens .............................................................................
Employer Services Agreement and Profile ......................................................
Insurance Match Debt Inquiry Agreement and Profile ....................................
e-NMSN: Plan Administrator Profile ................................................................
e-NMSN: Employer Profile ...............................................................................
e-NMSN: State Profile .....................................................................................
e-IWO Employer/Payroll Provider Profile ........................................................
FAST Levy Financial Institution Profile ............................................................
Estimated Total Annual Burden
Hours: 9,461.08.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
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Total
annual
number of
responses per
respondent
52,284
20,040
6
0
20
4
117
2
Average
burden
hours per
response
1
1
1
0
1
1
1
1
Total
annual
burden
hours
0.15
0.08
0.08
0.22
0.22
0.22
0.08
0.08
7,842.60
1,603.20
0.48
0.00
4.40
0.88
9.36
0.16
Authority: 42 U.S.C. 653(m)(2) and 44
U.S.C. 3554.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary C. Jones,
ACF/OPRE Certifying Officer.
Food and Drug Administration
[FR Doc. 2024–15692 Filed 7–16–24; 8:45 am]
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[Docket No. FDA–2018–N–1262]
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher; VYVGART
HYTRULO (efgartigimod alfa and
hyaluronidase-qvfc)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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
SUMMARY:
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58166
Federal Register / Vol. 89, No. 137 / Wednesday, July 17, 2024 / Notices
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 the
supplemental application (Supplement5) for VYVGART HYTRULO
(efgartigimod alfa and hyaluronidaseqvfc), approved June 21, 2024, 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.
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 the
supplemental application (Supplement5) for VYVGART HYTRULO
(efgartigimod alfa and hyaluronidaseqvfc) 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/
DevelopingProductsforRare
DiseasesConditions/
RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about VYVGART
HYTRULO (efgartigimod alfa and
hyaluronidase-qvfc), go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: July 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
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[FR Doc. 2024–15695 Filed 7–16–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–1829]
Platform Technology Designation
Program; Draft Guidance for Industry;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
draft guidance for industry ‘‘Platform
Technology Designation Program for
Drug Development’’ that appeared in the
Federal Register of May 29, 2024. In the
notice of availability for the draft
guidance, FDA requested comments on
the proposed collection of information.
The Agency is taking this action in
response to requests for an extension to
allow interested persons additional time
to submit comments.
DATES: FDA is extending the comment
period on the draft guidance for
industry ‘‘Platform Technology
Designation Program for Drug
Development’’ published May 29, 2024,
89 FR 46406. Either electronic or
written comments must be submitted by
August 28, 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
August 28, 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.
SUMMARY:
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
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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–
2024–D–1829 for ‘‘Platform Technology
Designation Program for Drug
Development.’’ 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
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
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]]>Agencies
[Federal Register Volume 89, Number 137 (Wednesday, July 17, 2024)]
[Notices]
[Pages 58165-58166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15695]
-----------------------------------------------------------------------
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; VYVGART HYTRULO (efgartigimod alfa and
hyaluronidase-qvfc)
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
[[Page 58166]]
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
the supplemental application (Supplement-5) for VYVGART HYTRULO
(efgartigimod alfa and hyaluronidase-qvfc), approved June 21, 2024,
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 the supplemental application (Supplement-5) for VYVGART
HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) 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 VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-
qvfc), go to the ``Drugs@FDA'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: July 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15695 Filed 7-16-24; 8:45 am]
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