Notice of Supplemental Funding, Poison Control Centers Program, 76855-76856 [2024-21402]
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76855
Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Total annual
responses
Average burden
per response
Total hours
Labeling requirements for prescription drugs;
§§ 201.56 and 201.57.
Labeling applicable to medical gas containers;
§§ 201.161(b) and 201.328.
Exemption from barcode requirements § 201.25(d) .....
Safety labeling required under section 505(o)(4) of
the Federal Food, Drug, and Cosmetic Act (FD&C
Act), and rebuttal statement.
Safety labeling changes; posting approved letter on
application holder’s website.
Exceptions or alternatives to labeling requirements for
human drug product held by SNS; § 201.26.
Hypertension claims; recommended labeling considerations.
414
1.326
549
3,349 .....................
1,838,601
260
1,663
432,380
0.17 (10 minutes) ..
73,505
2
36
1
1
2
36
24 ..........................
6 ............................
48
216
351
1
351
4 ............................
1,404
1
1
1
32 ..........................
32
5
1
5
18 ..........................
90
Total ......................................................................
........................
........................
433,324
...............................
1,913,896
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our evaluation, we have
retained the currently approved
estimate that 414 applicants will
prepare an average of 549 prescription
drug labels annually, and assume it will
require 3,349 hours to design, test, and
submit to FDA as part of a new drug
application or a biologics license
application.
New medical gas containers must
meet applicable requirements found in
21 CFR part 211, as well as specific
labeling requirements in § 201.328.
Consistent with statutory authority
under the Consolidated Appropriations
Act, 2017 (Pub. L. 115–31), we have
revised the information collection to
include burden associated new medical
gas labeling requirements under
§ 201.161(b), established by a final rule
published in the Federal Register of
June 18, 2024 (89 FR 51738). We
estimate 260 respondents will incur
burden for the design, testing,
production, and submission of labeling
for new medical gas containers as
established in § 201.328 and assume an
average of 10 minutes (0.17) is required
for these activities.
Based on our evaluation, few requests
for exemption from barcode
requirements are received and we have
therefore made no changes to the
currently approved estimate for this
activity. Likewise, we have also retained
the currently approved estimate for
information collection activities
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Activity/21 CFR section
associated with safety labeling
requirements established in
section505(o)(4) of the FD&C Act.
Similarly, we retain the currently
approved estimate for exceptions to
labeling under § 201.26, however this
activity was previously approved in
OMB control number 0910–0614 and is
a new element to the collection, adding
1 response and 32 hours annually.
Finally, we have combined activity
elements associated with labeling
recommendations regarding drug
products that include a hypertension
indication as discussed in the
applicable guidance, reducing the
overall estimate for this element by 4
hours annually.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21436 Filed 9–18–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Supplemental Funding,
Poison Control Centers Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice of supplemental award.
HRSA is awarding
supplemental funds in fiscal year 2024
to provide coverage for calls to the tollfree Poison Help line that originate from
Puerto Rico. The current program period
of performance ends on August 31,
2024.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Maureen Perkins, MPH; Team Lead;
Poison Control Program; Division of
Child, Adolescent and Family Health;
Maternal and Child Health Bureau;
HRSA, at mperkins@hrsa.gov and 301–
443–9163.
SUPPLEMENTARY INFORMATION:
Intended Recipient(s) of the Award:
New York City Health & Hospitals
Corporation.
Amount of Non-Competitive
Award(s): One award of $265,188.
Project Period: September 1, 2024, to
August 31, 2025.
Assistance Listing (CFDA) Number:
93.253.
Award Instrument: Supplement for
Poison Control Services.
Authority: 42 U.S.C. 300d–73 (title
XII, 1273 of the Public Health Service
Act).
TABLE 1—RECIPIENT AND AWARD AMOUNT
Grant No.
Award recipient name
H4BHS15477 ...................................................
New York City Health & Hospitals Corporation ..................................
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State
19SEN1
NY
Award amount
$265,188
76856
Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
Justification: This non-competitive
supplement will award $265,188 to New
York City Health & Hospitals
Corporation to fund the New York City
Poison Control Center (NYCPCC) to
provide coverage of calls to the toll-free
Poison Help line originating from Puerto
Rico from September 1, 2024, through
August 31, 2025. The Poison Control
Program ensures that individuals can
call a national toll-free Poison Help line
(1–800–222–1222) to connect to a local
poison control center in a poisoning
emergency. As required by statute, calls
to the Poison Help line must be directed
to poison control centers that are
accredited. In the most recent Notice of
Funding Opportunity, HRSA–24–045,
no application was received to respond
to calls from Puerto Rico. To ensure
uninterrupted poison control center
coverage for Puerto Rico, HRSA
identified NYCPCC as an accredited
center that is capable of responding to
Puerto Rico’s approximately 5,000 calls
annually. NYCPCC historically has been
able to provide temporary coverage for
Puerto Rico’s calls on an ad hoc basis
and has the qualifications, experience,
and personnel to do so on a longer-term
basis. Funds will be used for project
activities within the scope of the current
award (as announced in HRSA–24–045);
supplemental funds will support
NYCPCC to provide coverage to calls to
the Poison Help line originating from
Puerto Rico for a period of 1 year.
Future funds for coverage for Puerto
Rico may be made available in a Notice
of Funding Opportunity for a project
period of September 1, 2025, to August
31, 2028, subject to the availability of
funding for the activity.
Carole Johnson,
Administrator.
[FR Doc. 2024–21402 Filed 9–18–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Supplemental Award; Alumni
Peer Navigator Services Pilot
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of supplemental award.
AGENCY:
HRSA will provide
supplemental award funds in fiscal year
SUMMARY:
2024 to the current recipient of the
Supporting Healthy Start (HS)
Performance Project cooperative
agreement (HRSA–24–038) to support
the second year of the Alumni Peer
Navigator (APN) Services Pilot.
FOR FURTHER INFORMATION CONTACT:
Aaron M. Lopata, MD, MPP, Senior
Medical Officer, Division of HS and
Perinatal Services, Maternal and Child
Health Bureau, HRSA, at alopata@
hrsa.gov and (312) 315–4270.
SUPPLEMENTARY INFORMATION:
Intended Recipient(s) of the Award:
The National Institute for Children’s
Health Quality (NICHQ).
Amount of Competitive or NonCompetitive Award(s): $601,851.
Supplemental funding for similar
activities may be considered in future
years, subject to the availability of
funding for the activity and the
satisfactory performance of the
recipient.
Project Period: June 1, 2024, to May
31, 2029.
Assistance Listing (CFDA) Number:
93.926.
Award Instrument: Supplement.
Authority: 42 U.S.C. 254c–8 (title III,
330H of the Public Health Service Act).
lotter on DSK11XQN23PROD with NOTICES1
TABLE 1—RECIPIENT AND AWARD AMOUNTS
Grant No.
Award recipient name
City, State
UF5MC32750 ..........................
National Institute for Children’s Health Quality ........................
Boston, MA .............................
Justification: NICHQ, as the current
HS Technical Assistance Support
Center, and recipient of the Supporting
HS Performance Project, provides
national support to all HRSA HS project
grantees. The supplemental funds will
support new and continued APN
activities. APN activities aim to reduce
infant mortality rates, address
disparities in maternal and infant health
outcomes, and address social
determinants of health. APNs are former
HS participants who have navigated
complex and often disparate health,
education, and social services. These
former HS participants, known as ‘‘peer
navigators,’’ help current HS families by
providing guidance and information
about public benefits and help to
address issues such as food insecurity,
unstable housing, and lack of
transportation.
NICHQ will use supplemental funds
to support HS grantees to implement
this peer-to-peer workforce model, the
APN Services Pilot. The APN Services
Pilot was previously known as the
VerDate Sep<11>2014
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Benefits Bundle Pilot. The APN Services
Pilot is an interagency collaboration
between the Department of Health and
Human Services and the Office of
Management and Budget/U.S. Digital
Service.
The pilot consists of five HS projects
in Florence, SC, Atlanta, GA, Baton
Rouge, LA, Los Angeles, CA and
Stoneville, Mississippi.
Carole Johnson,
Administrator.
Award
amount
$601,851
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
ACTION:
Notice.
[FR Doc. 2024–21407 Filed 9–18–24; 8:45 am]
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76855-76856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21402]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Supplemental Funding, Poison Control Centers Program
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice of supplemental award.
-----------------------------------------------------------------------
SUMMARY: HRSA is awarding supplemental funds in fiscal year 2024 to
provide coverage for calls to the toll-free Poison Help line that
originate from Puerto Rico. The current program period of performance
ends on August 31, 2024.
FOR FURTHER INFORMATION CONTACT: Maureen Perkins, MPH; Team Lead;
Poison Control Program; Division of Child, Adolescent and Family
Health; Maternal and Child Health Bureau; HRSA, at [email protected]
and 301-443-9163.
SUPPLEMENTARY INFORMATION:
Intended Recipient(s) of the Award: New York City Health &
Hospitals Corporation.
Amount of Non-Competitive Award(s): One award of $265,188.
Project Period: September 1, 2024, to August 31, 2025.
Assistance Listing (CFDA) Number: 93.253.
Award Instrument: Supplement for Poison Control Services.
Authority: 42 U.S.C. 300d-73 (title XII, 1273 of the Public Health
Service Act).
Table 1--Recipient and Award Amount
----------------------------------------------------------------------------------------------------------------
Grant No. Award recipient name State Award amount
----------------------------------------------------------------------------------------------------------------
H4BHS15477............................... New York City Health & NY $265,188
Hospitals Corporation.
----------------------------------------------------------------------------------------------------------------
[[Page 76856]]
Justification: This non-competitive supplement will award $265,188
to New York City Health & Hospitals Corporation to fund the New York
City Poison Control Center (NYCPCC) to provide coverage of calls to the
toll-free Poison Help line originating from Puerto Rico from September
1, 2024, through August 31, 2025. The Poison Control Program ensures
that individuals can call a national toll-free Poison Help line (1-800-
222-1222) to connect to a local poison control center in a poisoning
emergency. As required by statute, calls to the Poison Help line must
be directed to poison control centers that are accredited. In the most
recent Notice of Funding Opportunity, HRSA-24-045, no application was
received to respond to calls from Puerto Rico. To ensure uninterrupted
poison control center coverage for Puerto Rico, HRSA identified NYCPCC
as an accredited center that is capable of responding to Puerto Rico's
approximately 5,000 calls annually. NYCPCC historically has been able
to provide temporary coverage for Puerto Rico's calls on an ad hoc
basis and has the qualifications, experience, and personnel to do so on
a longer-term basis. Funds will be used for project activities within
the scope of the current award (as announced in HRSA-24-045);
supplemental funds will support NYCPCC to provide coverage to calls to
the Poison Help line originating from Puerto Rico for a period of 1
year. Future funds for coverage for Puerto Rico may be made available
in a Notice of Funding Opportunity for a project period of September 1,
2025, to August 31, 2028, subject to the availability of funding for
the activity.
Carole Johnson,
Administrator.
[FR Doc. 2024-21402 Filed 9-18-24; 8:45 am]
BILLING CODE 4165-15-P
