Notice of Supplemental Award; Early Childhood Developmental Health Systems Cooperative Agreement, 51330-51331 [2023-16494]
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Federal Register / Vol. 88, No. 148 / Thursday, August 3, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
In July 2017, the Centers for Disease
Control and Prevention notified FDA of
multiple cases of B. cepacia infections
in pediatric patients at Stanford
Children’s Health Lucile Packard
Children’s Hospital in Palo Alto, CA
and Johns Hopkins Children’s Center in
Baltimore, MD. FDA investigated and
collected bottles of Diocto Liquid from
these medical centers. The collected
bottles were from the same lot that
Pharmatech distributed in March
2017—the same lot that Pharmatech
failed to disclose to FDA. Several of the
bottles contained total aerobic microbial
counts and total yeast and mold counts
in excess of acceptable limits and some
of the bottles also tested positive for the
presence of B. cepacia.
In September 2017, FDA initiated an
inspection of Ofcus Pharma. During that
inspection the individual Mr. Figueroa
asked to misrepresent to FDA that they
owned Ofcus Pharma, did in fact make
false statements to an FDA investigator
when they told the investigator they had
full ownership of Ofcus Pharma.
Based on this conviction, FDA sent
Mr. Figueroa by certified mail on March
20, 2023, a notice proposing to
permanently debar him from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on a finding, under section
306(a)(2)(B) of the FD&C Act, that Mr.
Figueroa was convicted, as set forth in
section 306(l)(1) of the FD&C Act, of a
felony under Federal law for conduct
relating to the regulation of a drug
product under the FD&C Act. The
proposal also offered Mr. Figueroa an
opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
file a timely request for a hearing would
constitute an election not to use the
opportunity for a hearing and a waiver
of any contentions concerning this
action. Mr. Figueroa received the
proposal on March 30, 2023. He did not
request a hearing within the timeframe
prescribed by regulation and has,
therefore, waived his opportunity for a
hearing and any contentions concerning
his debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Figueroa
has been convicted of a felony under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act.
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As a result of the foregoing finding,
Mr. Figueroa is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application,
effective (see DATES) (see sections
306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C
Act). Any person with an approved or
pending drug product application who
knowingly employs or retains as a
consultant or contractor, or otherwise
uses in any capacity the services of Mr.
Figueroa during his debarment, will be
subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6))). If Mr. Figueroa provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment he will be subject to civil
money penalties (section 307(a)(7) of the
FD&C Act). In addition, FDA will not
accept or review any abbreviated new
drug application from Mr. Figueroa
during his period of debarment, other
than in connection with an audit under
section 306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that,
for purposes of sections 306 and 307 of
the FD&C Act, a ‘‘drug product’’ is
defined as a ‘‘drug subject to regulation
under section 505, 512, or 802 of this
Act [(21 U.S.C. 355, 360b, 382)] or under
section 351 of the Public Health Service
Act [(42 U.S.C. 262)]’’ (section 201(dd)
of the FD&C Act (21 U.S.C. 321(dd))).
and International Affairs, Food and
Drug Administration, 301–796–9115,
Lisa.Granger@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of July 28, 2023 (88 FR
48881), in FR Doc. 2023–15911, the
following correction is made:
On page 48883, in section II.C., table
4, ‘‘CDER Actual FY 2022 Workload
Volumes and Predicted FY 2024
Workload Volumes,’’ in the third
column (‘‘FY 2024 predictions’’), fourth
row (‘‘NDA/BLA Original’’), ‘‘1,136’’ is
corrected to read ‘‘136.’’
Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
SUMMARY:
[FR Doc. 2023–16550 Filed 8–2–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2850]
Prescription Drug User Fee Rates for
Fiscal Year 2024; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Prescription Drug User Fee
Rates for Fiscal Year 2024’’ that
appeared in the Federal Register of July
28, 2023. The document announced the
rates for prescription drug user fees for
fiscal year 2024. The document was
published with an incorrect value in a
table. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy, Legislation,
SUMMARY:
PO 00000
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Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–16575 Filed 8–2–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Supplemental Award; Early
Childhood Developmental Health
Systems Cooperative Agreement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of a HRSA-initiated
supplemental award.
AGENCY:
HRSA announces the award
of a supplement for a total of
approximately $1 million in fiscal year
(FY) 2023 for the Early Childhood
Developmental Health Systems (ECDHS)
cooperative agreement. The supplement
will provide approximately $600,000 to
the current recipient during the period
of September 30, 2023, to September 29,
2024, to continue to support the
implementation, spread, and scale of
early childhood development (ECD)
expert integration, and associated early
childhood systems development. This
includes providing intensive,
individualized technical assistance (TA)
to four additional Transforming
Pediatrics in Early Childhood (TPEC)
Program state-level recipients. In
addition, the supplement further
includes approximately $400,000 to
provide TA to HRSA-funded health
centers who are expanding early
childhood developmental services
through ECD funding.
FOR FURTHER INFORMATION CONTACT:
Natalie Surfus, MPH; Public Health
Analyst, Division of Home Visiting and
Early Childhood Systems, Maternal and
Child Health Bureau. Telephone: (240)
381–8202; Email: NSurfus@hrsa.gov.
SUPPLEMENTARY INFORMATION:
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51331
Federal Register / Vol. 88, No. 148 / Thursday, August 3, 2023 / Notices
Intended Recipient of the Award:
ZERO TO THREE National Center for
Infant, Toddler and Families, Inc.
Amount of Non-Competitive Award:
One combined supplemental award at
$1 million.
Project Period: September 30, 2023, to
September 29, 2024.
for the provision of TA to HRSA
funding recipients.
Authorities: Social Security Act, title
V, section 501(a)(2) (42 U.S.C.
701(a)(2)); and section 330(l) of the
Public Health Service Act (42 U.S.C.
254b(l)).
Assistance Listing (CFDA) Numbers:
93.110/93.129.
Award Instrument: Supplement for
continued support of the
implementation, spread, and scale of
ECD expert integration and associated
systems development nationwide and
ddrumheller on DSK120RN23PROD with NOTICES1
TABLE 1—RECIPIENTS AND AWARD AMOUNTS
Grant No.
Award recipient name
City, state
UK2MC46349 ............
ZERO TO THREE National Center for Infant, Toddler, and Families, Inc ...............
Washington, DC ................
Justification: HRSA awarded the
ECDHS program in FY 2022 under the
Title V Maternal and Child Health
Services Block Grant for Special Projects
of Regional and National Significance
(SPRANS). Programmatic expectations
for the recipient include providing
intensive, individualized TA to four
state-level TPEC program (HRSA–22–
141) recipients, along with specialized
and universal TA opportunities with a
nationwide reach, to support, spread,
and scale ECD expert integration and
associated systems development. The
Consolidated Appropriations Act, 2023,
Public Law 117–328, division B, title II,
included additional SPRANS funding;
House Report 117–403, which
accompanied the Consolidated
Appropriations Act, 2023, included an
increase for ECD Expert Grants. HRSA,
through its Maternal and Child Health
Bureau, will therefore provide a
supplement of approximately $600,000
in SPRANS funding to the current
ECDHS recipient to (1) expand
intensive, individualized TA to an
additional four TPEC recipients; (2)
support alignment between TPEC
recipients, other Maternal and Child
Health Bureau-funded early childhood
partners, and HRSA-funded health
centers to support the integration of
these efforts within a comprehensive
early childhood system; and (3) support
the development and dissemination of
additional TA resources with
nationwide reach and scope, including
outreach and coordination with other
TA entities.
House Report 117–403 also provided
guidance to HRSA’s Bureau of Primary
Health Care to use appropriated funds
‘‘to expand and further integrate early
childhood development services and
expertise, including by hiring or
contracting for early childhood
development specialists,’’ and ‘‘to create
a service expansion grant opportunity
for health centers, with training and
technical assistance to be provided by
the Maternal and Child Health
Bureau. . .’’ (italics added). To support
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FY23
supplement award amount
$1 million.
that service expansion grant opportunity
(HRSA–23–028), an additional
supplement of approximately $400,000
in Health Center Program funding will
be provided under this supplement to
the ECDHS recipient to adapt or create
TA resources on ECD topics for all
HRSA-funded health centers, provide
specialized TA to subsets of HRSAfunded health centers based on
particular needs, and support health
centers’ connection to and alignment
with other relevant efforts to incorporate
ECD in pediatric health services. TA
resources developed using this funding
will also be made available by the
recipient, at no additional cost, to other
HRSA-funded entities and to early
childhood system programs and leaders
pursuing aligned objectives, including
through HRSA-supported dissemination
channels.
Collectively, the supplements will
leverage existing knowledge, expertise,
and opportunity across HRSA and its
non-federal partners to improve
equitable access to a continuum of ECD
services for families nationwide and
will build capacity of the health system
to deliver high-quality pediatric services
that address the holistic needs of
children and families.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Carole Johnson,
Administrator.
DATES:
[FR Doc. 2023–16494 Filed 8–2–23; 8:45 am]
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Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Maternal and Child Health
Bureau Performance Measures for
Discretionary Grant Information
System, OMB No. 0915–0298—
Revision.
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than September 5,
2023.
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
Collection Clearance Officer at
ADDRESSES:
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PO 00000
Health Resources and Services
Administration
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[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51330-51331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16494]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Supplemental Award; Early Childhood Developmental
Health Systems Cooperative Agreement
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice of a HRSA-initiated supplemental award.
-----------------------------------------------------------------------
SUMMARY: HRSA announces the award of a supplement for a total of
approximately $1 million in fiscal year (FY) 2023 for the Early
Childhood Developmental Health Systems (ECDHS) cooperative agreement.
The supplement will provide approximately $600,000 to the current
recipient during the period of September 30, 2023, to September 29,
2024, to continue to support the implementation, spread, and scale of
early childhood development (ECD) expert integration, and associated
early childhood systems development. This includes providing intensive,
individualized technical assistance (TA) to four additional
Transforming Pediatrics in Early Childhood (TPEC) Program state-level
recipients. In addition, the supplement further includes approximately
$400,000 to provide TA to HRSA-funded health centers who are expanding
early childhood developmental services through ECD funding.
FOR FURTHER INFORMATION CONTACT: Natalie Surfus, MPH; Public Health
Analyst, Division of Home Visiting and Early Childhood Systems,
Maternal and Child Health Bureau. Telephone: (240) 381-8202; Email:
[email protected].
SUPPLEMENTARY INFORMATION:
[[Page 51331]]
Intended Recipient of the Award: ZERO TO THREE National Center for
Infant, Toddler and Families, Inc.
Amount of Non-Competitive Award: One combined supplemental award at
$1 million.
Project Period: September 30, 2023, to September 29, 2024.
Assistance Listing (CFDA) Numbers: 93.110/93.129.
Award Instrument: Supplement for continued support of the
implementation, spread, and scale of ECD expert integration and
associated systems development nationwide and for the provision of TA
to HRSA funding recipients.
Authorities: Social Security Act, title V, section 501(a)(2) (42
U.S.C. 701(a)(2)); and section 330(l) of the Public Health Service Act
(42 U.S.C. 254b(l)).
Table 1--Recipients and Award Amounts
----------------------------------------------------------------------------------------------------------------
FY23 supplement award
Grant No. Award recipient name City, state amount
----------------------------------------------------------------------------------------------------------------
UK2MC46349........................... ZERO TO THREE National Washington, DC......... $1 million.
Center for Infant,
Toddler, and Families,
Inc.
----------------------------------------------------------------------------------------------------------------
Justification: HRSA awarded the ECDHS program in FY 2022 under the
Title V Maternal and Child Health Services Block Grant for Special
Projects of Regional and National Significance (SPRANS). Programmatic
expectations for the recipient include providing intensive,
individualized TA to four state-level TPEC program (HRSA-22-141)
recipients, along with specialized and universal TA opportunities with
a nationwide reach, to support, spread, and scale ECD expert
integration and associated systems development. The Consolidated
Appropriations Act, 2023, Public Law 117-328, division B, title II,
included additional SPRANS funding; House Report 117-403, which
accompanied the Consolidated Appropriations Act, 2023, included an
increase for ECD Expert Grants. HRSA, through its Maternal and Child
Health Bureau, will therefore provide a supplement of approximately
$600,000 in SPRANS funding to the current ECDHS recipient to (1) expand
intensive, individualized TA to an additional four TPEC recipients; (2)
support alignment between TPEC recipients, other Maternal and Child
Health Bureau-funded early childhood partners, and HRSA-funded health
centers to support the integration of these efforts within a
comprehensive early childhood system; and (3) support the development
and dissemination of additional TA resources with nationwide reach and
scope, including outreach and coordination with other TA entities.
House Report 117-403 also provided guidance to HRSA's Bureau of
Primary Health Care to use appropriated funds ``to expand and further
integrate early childhood development services and expertise, including
by hiring or contracting for early childhood development specialists,''
and ``to create a service expansion grant opportunity for health
centers, with training and technical assistance to be provided by the
Maternal and Child Health Bureau. . .'' (italics added). To support
that service expansion grant opportunity (HRSA-23-028), an additional
supplement of approximately $400,000 in Health Center Program funding
will be provided under this supplement to the ECDHS recipient to adapt
or create TA resources on ECD topics for all HRSA-funded health
centers, provide specialized TA to subsets of HRSA-funded health
centers based on particular needs, and support health centers'
connection to and alignment with other relevant efforts to incorporate
ECD in pediatric health services. TA resources developed using this
funding will also be made available by the recipient, at no additional
cost, to other HRSA-funded entities and to early childhood system
programs and leaders pursuing aligned objectives, including through
HRSA-supported dissemination channels.
Collectively, the supplements will leverage existing knowledge,
expertise, and opportunity across HRSA and its non-federal partners to
improve equitable access to a continuum of ECD services for families
nationwide and will build capacity of the health system to deliver
high-quality pediatric services that address the holistic needs of
children and families.
Carole Johnson,
Administrator.
[FR Doc. 2023-16494 Filed 8-2-23; 8:45 am]
BILLING CODE 4165-15-P
