Attachment A2 - 60-day FRN Publication_Final

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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
under section 510(j)(3)(B) of the FD&C
Act). Listed drugs subject to reporting
include human drug products
(including non-exempt biological
products) marketed under an approved
application, animal drug products
marketed under an approved
application, medical gases, homeopathic
products, products marketed in
accordance with requirements under
section 505G of the FD&C Act (21 U.S.C.
355h), often referred to as over-thecounter monograph drugs, and animal
drug products that are not approved,
conditionally approved, or indexed
under sections 512, 571, and 572 of the
FD&C Act (21 U.S.C. 360b, 360ccc, and
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This guidance finalizes the draft
guidance entitled ‘‘Reporting Amount of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comments received on the draft
guidance as the guidance was finalized.
Changes from the draft to the final
guidance include changes to the
recommended timeframe for report
submission, as well as changes to the
recommended units for the reporting of
drugs that are not drug products in
finished package form. These changes
were made in response to public
comments received and in the interest
of facilitating drug amount data
submission and improving data
accuracy. Revisions also were made to
clarify the reporting requirements
applicable to registrants of listed drugs
across the drug supply chain, including
contract manufacturers. Further
revisions were made to clarify and
further detail how FDA plans to use
data derived from the drug amount
reporting program, including data
submitted by each registrant in the drug
supply chain.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Reporting Amount
of Listed Drugs and Biological Products
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
of the applicable statutes and
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
notifications of discontinuance or
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
information relating to 21 CFR 600.81
and 600.82 have been approved under
OMB control number 0910–0308. The
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]
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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.

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