Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; FABHALTA, 2624 [2024-00688]
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Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices
• Collecting program official,
caseworker, and resident beneficiary
level data from the Affordable Housing
and Supportive Services Demonstration.
• Conducting interviews with
program officials and caseworkers that
administer the supportive services to
residents living in affordable housing
units to better understand their program
implementation efforts and responses to
resident needs.
• Conducting focus groups with
beneficiary residents to understand their
needs and experiences with the
supportive services offered in their
affordable housing residence.
• Administering a self-sufficiency
matrix to beneficiary residents to assess
any change or improvement in
beneficiary resident reporting of overall
self-sufficiency and wellbeing, which is
measured using several indicators, with
the receipt of additional supportive
services in the affordable housing
setting.
Respondents: There will be three
types of respondents to the proposed
instruments. First, the direct
beneficiaries living in the residential
housing communities will respond to
instruments 1, 2, and 3. Second, the
program directors/administrative staff
will respond to instruments 4, 5, 6, and
7. Finally, the caseworkers providing
direct support to beneficiaries will
respond to instrument 8. Caseworkers
may also be asked to support the
implementation and administration of
instruments 1, 2, and 3.
ANNUAL BURDEN ESTIMATES
Instrument
ddrumheller on DSK120RN23PROD with NOTICES1
Total
number of
responses
per
respondent
Total
number of
respondents
Average
burden
hours per
response
Total/
annual
burden
hours
1—Self-Sufficiency Matrix ................................................................................................
2—Service Receipt Questionnaire ..................................................................................
3—Resident Focus Group ...............................................................................................
4—Quarterly PPR Questions ...........................................................................................
5—Semi-Annual Report MANDATORY ...........................................................................
6—Semi-Annual Report OPTIONAL ...............................................................................
7—Interviews of Program Directors ................................................................................
8—Interviews of Caseworkers .........................................................................................
560
560
25
9
9
3
18
18
2
2
1
4
2
2
1
1
1.5
.25
1.5
2
3
1
1.5
1
1,680
280
37.5
72
54
6
27
18
Estimated Total Annual Burden Hours .....................................................................
....................
....................
....................
2,174.5
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.
Comments will be considered and any
necessary updates to materials made
prior to, and responses provided in, the
submission to OMB that will follow this
public comment period.
Authority: Sec. 1110, Social Security
Act, 42 U.S.C. 1310.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–00648 Filed 1–12–24; 8:45 am]
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18:57 Jan 12, 2024
Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0065]
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
approval of a product redeeming a
material threat medical countermeasure
(MCM) priority review voucher. The
Federal Food, Drug, and Cosmetic Act
(FD&C Act) authorizes FDA to award
priority review vouchers to sponsors of
approved material threat MCM product
applications that meet certain criteria.
FDA is required to publish notice of the
issuance of material threat MCM
priority review vouchers as well as the
approval of products redeeming a
voucher. FDA has determined that
FABHALTA (iptacopan) capsules,
approved December 5, 2023, meets the
redemption criteria.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 9990
Under
section 565A of the FD&C Act (21 U.S.C.
360bbb–4a) FDA will report the
issuance of material threat MCM
priority review vouchers and the
approval of products for which a
voucher was redeemed. FDA has
determined that the application for
FABHALTA (iptacopan) capsules,
approved December 5, 2023, meets the
redemption criteria.
For further information about the
material threat MCM Priority Review
Voucher Program and for a link to the
full text of section 565A of the FD&C
Act, go to https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/21st-century-cures-act-mcmrelated-cures-provisions#prv. For
further information about FABHALTA
(iptacopan) capsules go to the ‘‘Drugs@
FDA’’ website at https://www.accessdata.
fda.gov/scripts/cder/daf/.
SUPPLEMENTARY INFORMATION:
Notice of Approval of Product Under
Voucher: Material Threat Medical
Countermeasure Priority Review
Voucher; FABHALTA
AGENCY:
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
Dated: January 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–00688 Filed 1–12–24; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 89, Number 10 (Tuesday, January 16, 2024)]
[Notices]
[Page 2624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00688]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0065]
Notice of Approval of Product Under Voucher: Material Threat
Medical Countermeasure Priority Review Voucher; FABHALTA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
approval of a product redeeming a material threat medical
countermeasure (MCM) priority review voucher. The Federal Food, Drug,
and Cosmetic Act (FD&C Act) authorizes FDA to award priority review
vouchers to sponsors of approved material threat MCM product
applications that meet certain criteria. FDA is required to publish
notice of the issuance of material threat MCM priority review vouchers
as well as the approval of products redeeming a voucher. FDA has
determined that FABHALTA (iptacopan) capsules, approved December 5,
2023, meets the redemption criteria.
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: Under section 565A of the FD&C Act (21
U.S.C. 360bbb-4a) FDA will report the issuance of material threat MCM
priority review vouchers and the approval of products for which a
voucher was redeemed. FDA has determined that the application for
FABHALTA (iptacopan) capsules, approved December 5, 2023, meets the
redemption criteria.
For further information about the material threat MCM Priority
Review Voucher Program and for a link to the full text of section 565A
of the FD&C Act, go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions#prv. For further information about
FABHALTA (iptacopan) capsules go to the ``Drugs@FDA'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: January 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00688 Filed 1-12-24; 8:45 am]
BILLING CODE 4164-01-P
