Submission for OMB Review; State Court Improvement Program (OMB #0970-0307), 50847-50848 [2019-20890]
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Federal Register / Vol. 84, No. 187 / Thursday, September 26, 2019 / Notices
Comments must be received by
November 25, 2019.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ___, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
DATES:
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Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–855 Medicare Enrollment
Application for Clinics/Group Practices
and Other Suppliers
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
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requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Medicare
Enrollment Application for Clinics/
Group Practices and Other Suppliers
Revision; Use: The primary function of
the CMS–855B Medicare enrollment
application for suppliers, also known as
Health Diagnosing and Treating
Practitioners, is to gather information
from the supplier that tells CMS who
the supplier is, whether the supplier
meets certain qualifications to be a
Medicare health care provider or
supplier, where the supplier practices or
renders services, and other information
necessary to establish correct claims
payments.
The CMS–855B form includes an
attachment for Opioid Treatment
Programs (OTPs). This attachment is
only used to capture the OTP personnel
and consists of limited data fields
(name, Social Security Number,
National Provider Identifier, and license
number) in response to the ‘‘SUPPORT
for Patients and Communities Act’’ that
was signed into law on October 24,
2018. This legislation was designed to
alleviate the nationwide opioid crisis
by: (1) Reducing the abuse and supply
of opioids; (2) helping individuals
recover from opioid addiction and
supporting the families of these persons;
and (3) establishing innovative and
long-term solutions to the crisis. Section
2005 of the SUPPORT Act establishes a
new Medicare Part B benefit for opioid
use disorder (OUD) treatment services
furnished by opioid treatment programs
(OTPs) beginning on or after January 1,
2020. Form Number: CMS–855B (OMB
control number: 0938–New); Frequency:
Annually; Affected Public: Individuals
and households; Number of
Respondents: 327,696; Total Annual
Responses: 327,696; Total Annual
Hours: 522,041. For questions regarding
this collection contact Kim McPhillips
at 410–786–5374.
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50847
Dated: September 20, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–20871 Filed 9–25–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; State
Court Improvement Program (OMB
#0970–0307)
Children’s Bureau,
Administration for Children and
Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF) is
requesting a three-year extension of the
Court Improvement Program (CIP)
Program Instruction, Strategic Plan
Template, and Annual CIP SelfAssessment (OMB #0970–0307,
expiration 9/30/2019). There are
minimal updates to the form to reflect
new legislation. The collections are
necessary to continue operating the
program in compliance with
congressional reauthorization.
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
directly to the following:
Office of Management and Budget
Paperwork Reduction Project.
Email: OIRA_SUBMISSION@
OMB.EOP.GOV.
Attn: Desk Officer for the
Administration for Children and
Families.
Copies of the proposed collection may
be obtained by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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50848
Federal Register / Vol. 84, No. 187 / Thursday, September 26, 2019 / Notices
Description: The proposed collection
is a continuation of the current
collection and comprised of two
components: An application including a
strategic plan that is due once every five
years, and an annual self-assessment.
The next collection (annual selfassessment) will be due June 30, 2020.
The next five-year application will be
due in 2021.
Respondents: We anticipate the
highest state court of every state, Puerto
Rico and the US Virgin Islands to
respond. All 52 jurisdictions currently
participate in the program.
ANNUAL BURDEN ESTIMATES
Collection
Average
burden
hours per
response
Total burden
hours
Complete Application ...........................................................
Complete Program Assessment Report ..............................
2021
2020
2021
2022
52
52
52
52
1
1
1
1
92
77
77
77
4784
4004
4004
4004
Total ..............................................................................
........................
........................
........................
........................
16,796
Estimated Total Annual Burden
Hours: 4004 hours in 2020 and 2022;
8788 hours in 2021 (when both the selfassessment and the 5-year application
are due within the year)
Authority: Sec. 50761, P.L. 115–123.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–20890 Filed 9–25–19; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3935]
International Council for
Harmonisation of Technical
Requirements for Pharmaceuticals for
Human Use Global Meeting on E8(R1)
Guideline on General Considerations
for Clinical Trials; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting
The Food and Drug
Administration (FDA or Agency) is
announcing a public meeting entitled
‘‘International Council on
Harmonisation (ICH) Global Meeting on
E8(R1) Guideline on General
Considerations for Clinical Trials.’’ The
purpose of the public meeting is to
provide information on the draft revised
E8(R1) Guideline ‘‘General
Considerations for Clinical Trials’’ (ICH
E8 Guideline) following the closing of
the FDA comment period and closing of
the regional consultations conducted in
other ICH regions. The ICH E8
Guideline is being revised to provide
updated guidance that is both
appropriate and flexible enough to
address the increasing diversity of
SUMMARY:
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Number of
responses per
respondent
Number of
respondents
Year
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16:48 Sep 25, 2019
Jkt 247001
clinical trial designs and data sources
being employed to support regulatory
and other health policy decisions, while
retaining the underlying principles of
human subject protection and data
quality.
DATES: The public meeting will be held
on Thursday, October 31, 2019, from
8:30 a.m. to 5 p.m. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31
Conference Center, Rm. 1503 (the Great
Room), Silver Spring, MD 20993–0002.
The meeting will also be broadcast on
the web, allowing participants to join in
person or via the web. For those who
will attend in person, the entrance for
the public meeting participants (nonFDA employees) is through Building 1
where routine security check
procedures will be performed. For
parking and security information, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. For those who register
to attend the public meeting remotely
via the webcast, a link to access the
webcast will be emailed in advance of
the meeting.
FOR FURTHER INFORMATION CONTACT:
Amanda Roache, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6364,
Silver Spring, MD 20993–0002, 301–
796–4548, Amanda.Roache@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The ICH was established in 1990 as a
joint regulatory/industry project to
improve, through harmonization, the
efficiency of the process for developing
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and registering new medicinal products
in Europe, Japan, and the United States
without compromising the regulatory
requirements for safety and
effectiveness. One of the goals of
harmonization is to identify and then
reduce regional differences in technical
regulatory requirements for
pharmaceutical products while
preserving a consistently high standard
for drug efficacy, safety, and quality.
This is accomplished through the
development of internationally
harmonized guidelines developed
through a process of scientific
consensus with regulatory and industry
experts. FDA participates in ICH as a
founding member and implements all
ICH guidelines as FDA guidance.
In 2015, ICH was reformed to
establish it as a true global initiative and
to expand beyond the previous ICH
members. More involvement from
regulators around the world is expected,
as they join counterparts from Europe,
Japan, the United States, Canada, and
Switzerland as ICH regulatory members
and observers. Expanded involvement is
also anticipated from global regulated
pharmaceutical industry parties, joining
as ICH industry members and observers.
The reforms built on a 25-year track
record and have allowed ICH to
continue its successful delivery of
harmonized guidelines for global
pharmaceutical development and their
regulation.
The ICH E8 Guideline sets out general
principles on the conduct of clinical
trials, was adopted in 1997, and has not
undergone revision. Since its adoption,
clinical trial design and conduct have
become more complex, impacting the
time and cost required to develop drugs.
A wide range of both trial designs and
data sources play a role in drug
development and are not adequately
addressed in the original ICH E8
Guideline. Approaches are needed for
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]]>Agencies
[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Notices]
[Pages 50847-50848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20890]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; State Court Improvement Program (OMB
#0970-0307)
AGENCY: Children's Bureau, Administration for Children and Families,
HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF) is
requesting a three-year extension of the Court Improvement Program
(CIP) Program Instruction, Strategic Plan Template, and Annual CIP
Self-Assessment (OMB #0970-0307, expiration 9/30/2019). There are
minimal updates to the form to reflect new legislation. The collections
are necessary to continue operating the program in compliance with
congressional reauthorization.
DATES: Comments due within 30 days of publication. OMB is required to
make a decision concerning the collection of information between 30 and
60 days after publication of this document in the Federal Register.
Therefore, a comment is best assured of having its full effect if OMB
receives it within 30 days of publication.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent directly to the following:
Office of Management and Budget Paperwork Reduction Project.
Email: [email protected].
Attn: Desk Officer for the Administration for Children and
Families.
Copies of the proposed collection may be obtained by emailing
[email protected]. Alternatively, copies can also be obtained
by writing to the Administration for Children and Families, Office of
Planning, Research, and Evaluation, 330 C Street SW, Washington, DC
20201, Attn: OPRE Reports Clearance Officer. All requests, emailed or
written, should be identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
[[Page 50848]]
Description: The proposed collection is a continuation of the
current collection and comprised of two components: An application
including a strategic plan that is due once every five years, and an
annual self-assessment. The next collection (annual self-assessment)
will be due June 30, 2020. The next five-year application will be due
in 2021.
Respondents: We anticipate the highest state court of every state,
Puerto Rico and the US Virgin Islands to respond. All 52 jurisdictions
currently participate in the program.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Collection Year Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Complete Application............ 2021 52 1 92 4784
Complete Program Assessment 2020 52 1 77 4004
Report.........................
2021 52 1 77 4004
2022 52 1 77 4004
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................... .............. .............. .............. .............. 16,796
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 4004 hours in 2020 and 2022;
8788 hours in 2021 (when both the self-assessment and the 5-year
application are due within the year)
Authority: Sec. 50761, P.L. 115-123.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-20890 Filed 9-25-19; 8:45 am]
BILLING CODE 4184-01-P
