Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Pediatric Mental Health Care Access Program National Impact Study, 8210-8211 [2024-02357]
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Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices
product that is in finished package form,
a drug product that is not in finished
package form, an active pharmaceutical
ingredient, and other types of listed
drugs, except for biological products or
categories thereof exempted by an order
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360ccc–1).
This guidance finalizes the draft
guidance entitled ‘‘Reporting Amount of
Listed Drugs and Biological Products
Under Section 510(j)(3) of the FD&C
Act’’ published on November 1, 2021
(86 FR 60249). FDA considered
comments received on the draft
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Changes from the draft to the final
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submitted by each registrant in the drug
supply chain.
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consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
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thinking of FDA on ‘‘Reporting Amount
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Under Section 510(j)(3) of the FD&C
Act.’’ It does not establish any rights for
any person and is not binding on FDA
or the public. You can use an alternative
approach if it satisfies the requirements
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regulations.
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II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 207
pertaining to registration of producers of
drugs and listing of drugs in commercial
distribution have been approved under
OMB control number 0910–0045. The
collections of information in 21 CFR
parts 314 and 601 have been approved
under OMB control numbers 0910–0001
and 0910–0338, respectively. The
collections of information pertaining to
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interruption in manufacturing under 21
CFR 310.306 and 314.81(b)(3)(iii) have
been approved under OMB control
number 0910–0001. The collections of
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and 600.82 have been approved under
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collections of information in 21 CFR
parts 210 and 211 relating to current
good manufacturing practice have been
approved under OMB control number
0910–0139. The collections of
information in 21 CFR 514.80 have been
approved under OMB control number
0910–0284. The collections of
information in 21 CFR 514.87 have been
approved under OMB control number
0910–0659.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/animalveterinary/guidance-regulations/
guidance-industry, or https://
www.regulations.gov.
Dated: February 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–02369 Filed 2–5–24; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Pediatric
Mental Health Care Access Program
National Impact Study
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than April 8, 2024.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland, 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Pediatric Mental Health Care Access
Program National Impact Study, OMB
No. 0915–xxxx—[New].
Abstract: This notice describes an
information collection request for one of
HRSA’s Maternal and Child Health
Bureau programs, the Pediatric Mental
Health Care Access (PMHCA) Program.
The PMHCA Program aims to promote
behavioral health integration into
pediatric primary care by supporting the
development of state, regional, and
tribal pediatric mental health care
teleconsultation access programs. The
PMHCA Program supports pediatric
health professionals (HPs) 1 in their
SUMMARY:
1 Health professionals may include but are not
limited to pediatricians, family physicians,
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Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices
delivery of high-quality and timely
screening, assessment, treatment, and
referrals for children and adolescents
with behavioral health conditions
through the provision of
teleconsultation, care coordination
support/navigation (e.g., resource
identification and referrals), and
training and education.
The information will be collected
from participants in HRSA PMHCA
award recipient programs that were
funded in 2021, 2022, or 2023. The 2021
and 2022 PMHCA programs are
authorized by 42 U.S.C 254c–19 (Title
III, § 330M of the Public Health Service
Act), using funding appropriated by
Section 2712 of the American Rescue
Plan Act of 2021 (Pub. L. 117–2), and
the 2023 PMHCA programs are
authorized by 42 U.S.C 254c–19 (§ 330M
of the Public Health Service Act), as
amended by section 11005 of the
Bipartisan Safer Communities Act (Pub.
L. 117–159). To examine the impact of
the PMHCA program on children and
adolescents, this data collection will use
two instruments: the HP Impact Survey
and the Family/Caregiver Focus Group
Discussion (FGD). Additionally, family
members/caregivers identified by
PMHCA programs to participate in the
Family/Caregiver FGD will be asked
demographic questions (Family/
Caregiver Demographic Questionnaire)
about themselves and their child/
adolescent for the purpose of FGD
sampling and to inform qualitative data
analyses.
Need and Proposed Use of the
Information: This information is needed
by HRSA to examine PMHCA program
impacts on children/adolescents and
their families/caregivers in order to
guide future program decisions.
Specifically, data collected for the
PMHCA Impact Study will be used to
examine changes in children’s and
adolescents’ and their families’/
caregivers’ access to behavioral health
care; their subsequent receipt and
utilization of behavioral health care,
including culturally and linguistically
appropriate care; related behavioral
health impacts; and monetary and
societal cost-benefits. The study will
examine changes over time regarding
enrolled/participating HPs’ practices
with screening, diagnosing, treating, and
referring children and adolescents with
behavioral health conditions and assess
their perceptions of the behavioral
health impact of the PMHCA Program.
Additionally, the study will deepen
understanding of families’/caregivers’
experiences with behavioral health care
access, receipt, and utilization;
satisfaction with behavioral health care
services; and the impact of behavioral
health services on their children/
adolescents.
Likely Respondents:
• HP Impact Survey: Pediatricians,
family physicians, physician assistants,
Number of
respondents
ddrumheller on DSK120RN23PROD with NOTICES1
Form name
Number of
responses per
respondent
advanced practice nurses/nurse
practitioners, licensed practical nurses,
registered nurses, counselors, social
workers, medical assistants;
• Family/Caregiver FGD: Family
members and caregivers who have
sought and/or received behavioral
health care for their child(ren)/
adolescent(s); and
• Family/Caregiver Demographic
Questionnaire: Family members and
caregivers who have sought and/or
received behavioral health care for their
child(ren)/adolescent(s).
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
Total Estimated Annualized Burden
Hours:
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
HP Impact Survey ....................................................................
Family/Caregiver FGD .............................................................
Family/Caregiver Demographic Questionnaire ........................
21,070
42
270
2
1
1
42,140
42
270
0.17
1.00
.08
7,163.80
42
21.60
Total ..................................................................................
21,382
........................
42,452
........................
7,227.40
HRSA specifically requests comments
on: (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Maria G. Button,
Director, Executive Secretariat.
SUMMARY:
Health Resources and Services
Administration
Ryan White HIV/AIDS Program Part C
Early Intervention Services
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of supplemental award.
AGENCY:
BILLING CODE 4165–15–P
HRSA expects the availability
of additional funds for the RWHAP Part
C Early Intervention Services (EIS)
Program due to relinquishments,
physician assistants, advanced practice nurses/
nurse practitioners, licensed practical nurses,
registered nurses, counselors, social workers,
medical assistants, patient care navigators.
[FR Doc. 2024–02357 Filed 2–5–24; 8:45 am]
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reductions, closeouts, and unawarded
fiscal year (FY) 2023 new service area
competition funds in the estimated
amount of $4.2 million and intends to
distribute these supplemental funds
across the current cohort of RWHAP
Part C EIS recipients. The amount is
subject to change depending on the
availability of additional funds.
FOR FURTHER INFORMATION CONTACT:
CAPT Mahyar Mofidi, Director, Division
of Community HIV/AIDS Programs,
HIV/AIDS Bureau, Health Resources
and Services Administration, at
mmofidi@hrsa.gov or 301–443–2075.
E:\FR\FM\06FEN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 25 (Tuesday, February 6, 2024)]
[Notices]
[Pages 8210-8211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02357]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Pediatric
Mental Health Care Access Program National Impact Study
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than April 8,
2024.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland, 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Joella Roland, the
HRSA Information Collection Clearance Officer, at (301) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: Pediatric Mental Health Care
Access Program National Impact Study, OMB No. 0915-xxxx--[New].
Abstract: This notice describes an information collection request
for one of HRSA's Maternal and Child Health Bureau programs, the
Pediatric Mental Health Care Access (PMHCA) Program. The PMHCA Program
aims to promote behavioral health integration into pediatric primary
care by supporting the development of state, regional, and tribal
pediatric mental health care teleconsultation access programs. The
PMHCA Program supports pediatric health professionals (HPs) \1\ in
their
[[Page 8211]]
delivery of high-quality and timely screening, assessment, treatment,
and referrals for children and adolescents with behavioral health
conditions through the provision of teleconsultation, care coordination
support/navigation (e.g., resource identification and referrals), and
training and education.
---------------------------------------------------------------------------
\1\ Health professionals may include but are not limited to
pediatricians, family physicians, physician assistants, advanced
practice nurses/nurse practitioners, licensed practical nurses,
registered nurses, counselors, social workers, medical assistants,
patient care navigators.
---------------------------------------------------------------------------
The information will be collected from participants in HRSA PMHCA
award recipient programs that were funded in 2021, 2022, or 2023. The
2021 and 2022 PMHCA programs are authorized by 42 U.S.C 254c-19 (Title
III, Sec. 330M of the Public Health Service Act), using funding
appropriated by Section 2712 of the American Rescue Plan Act of 2021
(Pub. L. 117-2), and the 2023 PMHCA programs are authorized by 42 U.S.C
254c-19 (Sec. 330M of the Public Health Service Act), as amended by
section 11005 of the Bipartisan Safer Communities Act (Pub. L. 117-
159). To examine the impact of the PMHCA program on children and
adolescents, this data collection will use two instruments: the HP
Impact Survey and the Family/Caregiver Focus Group Discussion (FGD).
Additionally, family members/caregivers identified by PMHCA programs to
participate in the Family/Caregiver FGD will be asked demographic
questions (Family/Caregiver Demographic Questionnaire) about themselves
and their child/adolescent for the purpose of FGD sampling and to
inform qualitative data analyses.
Need and Proposed Use of the Information: This information is
needed by HRSA to examine PMHCA program impacts on children/adolescents
and their families/caregivers in order to guide future program
decisions. Specifically, data collected for the PMHCA Impact Study will
be used to examine changes in children's and adolescents' and their
families'/caregivers' access to behavioral health care; their
subsequent receipt and utilization of behavioral health care, including
culturally and linguistically appropriate care; related behavioral
health impacts; and monetary and societal cost-benefits. The study will
examine changes over time regarding enrolled/participating HPs'
practices with screening, diagnosing, treating, and referring children
and adolescents with behavioral health conditions and assess their
perceptions of the behavioral health impact of the PMHCA Program.
Additionally, the study will deepen understanding of families'/
caregivers' experiences with behavioral health care access, receipt,
and utilization; satisfaction with behavioral health care services; and
the impact of behavioral health services on their children/adolescents.
Likely Respondents:
HP Impact Survey: Pediatricians, family physicians,
physician assistants, advanced practice nurses/nurse practitioners,
licensed practical nurses, registered nurses, counselors, social
workers, medical assistants;
Family/Caregiver FGD: Family members and caregivers who
have sought and/or received behavioral health care for their
child(ren)/adolescent(s); and
Family/Caregiver Demographic Questionnaire: Family members
and caregivers who have sought and/or received behavioral health care
for their child(ren)/adolescent(s).
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours:
----------------------------------------------------------------------------------------------------------------
Number of Average burden Total
Form name Number of responses per Total per response burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
HP Impact Survey................... 21,070 2 42,140 0.17 7,163.80
Family/Caregiver FGD............... 42 1 42 1.00 42
Family/Caregiver Demographic 270 1 270 .08 21.60
Questionnaire.....................
----------------------------------------------------------------------------
Total.......................... 21,382 .............. 42,452 .............. 7,227.40
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on: (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-02357 Filed 2-5-24; 8:45 am]
BILLING CODE 4165-15-P
