Agency Information Collection Activities: Proposed Collection; Comment Request, 47973-47974 [2024-12197]
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Federal Register / Vol. 89, No. 108 / Tuesday, June 4, 2024 / Notices
Dated: May 29, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–12138 Filed 6–3–24; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Program
Project.
Date: July 11, 2024.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging, 5601
Fishers Lane, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Dario Dieguez, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institutes of Health,
National Institute on Aging, 5601 Fishers
Lane, Rockville, MD 20852, (301) 827–3101,
dario.dieguez@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: May 30, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
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Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2024–12211 Filed 6–3–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
0361.
Comments are invited on: (a) whether
the proposed collections of information
are 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) ways to enhance 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.
Project: Medications for the Treatment
of Opioid Use Disorder—42 CFR Part 8
(OMB No. 0930–0206) and Opioid
Treatment Programs (OTPs)—Extension
42 CFR part 8 establishes a
certification program managed by
SAMHSA’s Center for Substance Abuse
Treatment (CSAT). The regulation
requires that opioid treatment programs
(OTPs) be certified. ‘‘Certification’’ is
the process by which SAMHSA
determines that an OTP is qualified to
provide opioid use disorder treatment
under the federal opioid use disorder
treatment standards established by the
Secretary of Health and Human
Services. To become certified, an OTP
must be accredited by a SAMHSAapproved accreditation body. The
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47973
regulation also provides standards for
such services as individualized
treatment planning, medical care, and
assessment of patient outcomes. This
submission seeks continued approval of
the information collection requirements
in the regulation and of the forms used
in implementing the regulation.
SAMHSA currently has approval for
the Application for Certification to Use
Medications for the Treatment of Opioid
Use Disorder in a Treatment Program
Under 42 CFR 8.11 (Form SMA–162);
the Application for Approval as
Accreditation Body Under 42 CFR 8.3(b)
(Form SMA–163); and the Exception
Request and Record of Justification
Under 42 CFR 8.12 (Form SMA–168),
which may be used on a voluntary basis
by OTP practitioners when there is a
patient care situation in which the OTP
practitioner must make a treatment
decision that falls outside of the
required standards delineated in the
regulation. Form SMA–168 is a
simplified, standardized form to
facilitate the documentation, request,
and approval process for exceptions.
SAMHSA believes that the
recordkeeping requirements in the
regulation are customary and usual
practices within the medical and
rehabilitative communities and has not
calculated a response burden for them.
The recordkeeping requirements set
forth in 42 CFR 8.4, 8.11 and 8.12
include maintenance of the following: 5year retention by accreditation bodies of
certain records pertaining to
accreditation; documentation by an OTP
of the following: a patient’s medical
examination when admitted to
treatment, a patient’s medical history, a
care plan, any prenatal support
provided the patient if applicable, the
medical rationale for initial starting
doses above 50mg, the medical rationale
for a patient’s dosage schedule, and care
decisions made as a result of follow-up
medical examinations.
The tables that follow summarizes the
annual reporting burden associated with
the regulation, including burden
associated with the forms. There are
minor changes to these forms to
improve data collection, remove
unnecessary questions, and align terms
with the final 42 CFR part 8 rule
released February 2, 2024.
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47974
Federal Register / Vol. 89, No. 108 / Tuesday, June 4, 2024 / Notices
Number of
respondents
Form
Responses/
respondent
Total
responses
Hours/
response
Total hours
Estimated Annual Reporting Requirement Burden for Accreditation Bodies
SMA–163 .............................................................................
54
26.055
1,407
0.28
394
Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
SMA–162 .............................................................................
SMA–168 .............................................................................
751.33
1,302.67
17.976
17.977
13,506
23,418
0.08
0.08
1,081
1,873
Subtotal .........................................................................
Total .......................................................................
2,054
........................
17.977
........................
36,925
38,332
0.08
........................
2,954
3,348
Send comments to SAMHSA Reports
Clearance Officer, 5600 Fisher Lane,
Room 15E45, Rockville, MD 20852 OR
email a copy to samhsapra@
samhsa.hhs.gov. Written comments
should be received by August 5, 2024.
Alicia Broadus,
Public Health Advisor.
[FR Doc. 2024–12197 Filed 6–3–24; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
program, policy, and technical issues
may also be submitted via email to CBP
Export Manifest at cbpexportmanifest@
cbp.dhs.gov. In the subject line of the
email, please use ‘‘Comment on ACE
Export Manifest for Air Cargo Test’’.
Comments may be submitted at any
time during the test period.
FOR FURTHER INFORMATION CONTACT:
Thomas J. Pagano, Branch Chief, or
David Garcia, Program Manager,
Outbound Enforcement and Policy
Branch, Office of Field Operations, U.S.
Customs and Border Protection, via
email at cbpexportmanifest@
cbp.dhs.gov.
SUPPLEMENTARY INFORMATION:
Automated Commercial Environment
(ACE) Export Manifest for Air Cargo
Test: Renewal of Test
U.S. Customs and Border
Protection; Department of Homeland
Security.
ACTION: General notice.
AGENCY:
This notice announces that
CBP is renewing U.S. Customs and
Border Protection’s (CBP’s) Automated
Commercial Environment (ACE) Export
Manifest for Air Cargo Test, a National
Customs Automation Program (NCAP)
test concerning ACE export manifest
capability.
SUMMARY:
The voluntary pilot initially
began on August 10, 2015, was modified
and extended on August 14, 2017, and
was further extended on December 22,
2021. This renewal is effective June 4,
2024. The extended test will run for an
additional two years from the date of
publication of this notice in the Federal
Register.
ADDRESSES: Applications to participate
in the ACE Export Manifest for Air
Cargo Test must be submitted via email
to CBP Export Manifest at
cbpexportmanifest@cbp.dhs.gov. In the
subject line of the email, please use
‘‘ACE Export Manifest for Air Cargo Test
Application’’. Applications will be
accepted at any time during the test
period. Written comments concerning
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I. Background
The Automated Commercial
Environment (ACE) Export Manifest for
Air Cargo Test is a voluntary test in
which participants agree to submit
export manifest data to U.S. Customs
and Border Protection (CBP)
electronically, at least four hours prior
to loading of the cargo onto the aircraft
in preparation for departure from the
United States. The ACE Export Manifest
for Air Cargo Test is authorized under
§ 101.9(b) of title 19 of the Code of
Federal Regulations (19 CFR 101.9(b)),
which provides for the testing of
National Customs Automation Program
(NCAP) programs or procedures.
The ACE Export Manifest for Air
Cargo Test examines the functionality
regarding the filing of export manifest
data for air cargo electronically in ACE.
The ACE system creates a single
automated export processing platform
for certain export manifest, commodity,
licensing, export control, and export
targeting transactions. This will reduce
costs for CBP, partner government
agencies, and the trade community, as
well as improve facilitation of export
shipments through the supply chain.
The ACE Export Manifest for Air
Cargo Test will also assess the feasibility
of requiring the manifest information to
be filed electronically in ACE within a
specified time before the cargo is loaded
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on the aircraft. This capability will
enable CBP to calculate the risk and
effectively identify and inspect
shipments prior to loading of cargo to
ensure compliance with all U.S. export
laws.
CBP announced the procedures and
criteria related to participation in the
ACE Export Manifest for Air Cargo Test
in a notice published in the Federal
Register on July 10, 2015 (80 FR 39790).
This test was originally set to run for
approximately two years. On August 14,
2017, CBP extended the test period for
one additional year (82 FR 37888). At
that time, CBP also modified the
original notice, making certain of the
data elements optional, and opened the
test to accept additional applications for
participation from all parties who met
the eligibility requirements.
The data elements, unless noted
otherwise, are mandatory. Data elements
which are ‘‘mandatory’’ must be
provided to CBP for every shipment.
Data elements which are ‘‘conditional’’
must be provided to CBP only if the
particular information pertains to the
cargo. Data elements which are
‘‘optional’’ may be provided to CBP but
are not required. The data elements are
set forth below:
(1) Exporting Carrier
(2) Marks of nationality and registration
(3) Flight number
(4) Port of lading
(5) Port of unlading
(6) Scheduled date of departure
(7) Consolidator (conditional)
(8) De-consolidator (conditional)
(9) Air waybill type (Master, House,
Simple or Sub)
(10) Air waybill number
(11) Number of pieces and unit of
measure (optional)
(12) Weight (kg./lb.)
(13) Number of house air waybills
(optional)
(14) Shipper name and address
(15) Consignee name and address
(16) Cargo description
(17) AES Internal Transaction Number
(ITN) or AES Exemption Statement/
Exception Classification (per
shipment)
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]]>Agencies
[Federal Register Volume 89, Number 108 (Tuesday, June 4, 2024)]
[Notices]
[Pages 47973-47974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12197]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer on (240) 276-0361.
Comments are invited on: (a) whether the proposed collections of
information are 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) ways to enhance 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.
Project: Medications for the Treatment of Opioid Use Disorder--42 CFR
Part 8 (OMB No. 0930-0206) and Opioid Treatment Programs (OTPs)--
Extension
42 CFR part 8 establishes a certification program managed by
SAMHSA's Center for Substance Abuse Treatment (CSAT). The regulation
requires that opioid treatment programs (OTPs) be certified.
``Certification'' is the process by which SAMHSA determines that an OTP
is qualified to provide opioid use disorder treatment under the federal
opioid use disorder treatment standards established by the Secretary of
Health and Human Services. To become certified, an OTP must be
accredited by a SAMHSA-approved accreditation body. The regulation also
provides standards for such services as individualized treatment
planning, medical care, and assessment of patient outcomes. This
submission seeks continued approval of the information collection
requirements in the regulation and of the forms used in implementing
the regulation.
SAMHSA currently has approval for the Application for Certification
to Use Medications for the Treatment of Opioid Use Disorder in a
Treatment Program Under 42 CFR 8.11 (Form SMA-162); the Application for
Approval as Accreditation Body Under 42 CFR 8.3(b) (Form SMA-163); and
the Exception Request and Record of Justification Under 42 CFR 8.12
(Form SMA-168), which may be used on a voluntary basis by OTP
practitioners when there is a patient care situation in which the OTP
practitioner must make a treatment decision that falls outside of the
required standards delineated in the regulation. Form SMA-168 is a
simplified, standardized form to facilitate the documentation, request,
and approval process for exceptions.
SAMHSA believes that the recordkeeping requirements in the
regulation are customary and usual practices within the medical and
rehabilitative communities and has not calculated a response burden for
them. The recordkeeping requirements set forth in 42 CFR 8.4, 8.11 and
8.12 include maintenance of the following: 5-year retention by
accreditation bodies of certain records pertaining to accreditation;
documentation by an OTP of the following: a patient's medical
examination when admitted to treatment, a patient's medical history, a
care plan, any prenatal support provided the patient if applicable, the
medical rationale for initial starting doses above 50mg, the medical
rationale for a patient's dosage schedule, and care decisions made as a
result of follow-up medical examinations.
The tables that follow summarizes the annual reporting burden
associated with the regulation, including burden associated with the
forms. There are minor changes to these forms to improve data
collection, remove unnecessary questions, and align terms with the
final 42 CFR part 8 rule released February 2, 2024.
[[Page 47974]]
----------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours/
Form respondents respondent responses response Total hours
----------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Requirement Burden for Accreditation Bodies
----------------------------------------------------------------------------------------------------------------
SMA-163......................... 54 26.055 1,407 0.28 394
----------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
----------------------------------------------------------------------------------------------------------------
SMA-162......................... 751.33 17.976 13,506 0.08 1,081
SMA-168......................... 1,302.67 17.977 23,418 0.08 1,873
-------------------------------------------------------------------------------
Subtotal.................... 2,054 17.977 36,925 0.08 2,954
Total................... .............. .............. 38,332 .............. 3,348
----------------------------------------------------------------------------------------------------------------
Send comments to SAMHSA Reports Clearance Officer, 5600 Fisher
Lane, Room 15E45, Rockville, MD 20852 OR email a copy to
[email protected]. Written comments should be received by August
5, 2024.
Alicia Broadus,
Public Health Advisor.
[FR Doc. 2024-12197 Filed 6-3-24; 8:45 am]
BILLING CODE 4162-20-P
