Submission for OMB Review; Comment Request, 22853-22854 [2019-10418]
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Federal Register / Vol. 84, No. 97 / Monday, May 20, 2019 / Notices
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:
Description: The proposed data
collection will be used by the Office of
Child Care (OCC) to monitor State CCDF
Lead Agencies to determine and
validate compliance with CCDF
regulations and the approved State Plan.
The data collection is designed to
provide States with the flexibility to
propose an approach that is feasible and
sufficient to demonstrate compliance
based on State circumstances and
processes. State Lead Agencies will
participate in onsite monitoring based
on a 3-year cohort; submitting data once
every three years. OCC will begin
monitoring for compliance in Fiscal
Year 2019.
The data collection for the first 3years will focus on 11 topical areas: (1)
Disaster Preparedness, Response and
Recovery; (2) Consumer Education:
Dissemination of Information to Parents,
Providers, and General Public
(Monitoring Reports and Annual
Aggregate Data); (3) Twelve-Month
Eligibility; (4) Child: Staff Ratios and
Group Sizes; (5) Health and Safety
Requirements for Providers (11 Health
and Safety Topics); (6) Pre-Service/
Orientation and Ongoing Training
Requirements for Providers; (7)
Inspections for CCDF Licensed
Providers; (8) Inspections for LicenseExempt CCDF Providers; (9) Ratios for
Licensing Inspectors; (10) Child Abuse
and Neglect Reporting; and (11) Program
Integrity.
In developing the Onsite Monitoring
System, OCC convened a workgroup of
states to provide feedback and input on
the design of the Onsite Monitoring
System. As part of the workgroup
discussions, states emphasized the need
for individualized monitoring because
of the complexity of each state’s CCDF
structure and variance in
implementation strategies. As a
response, OCC developed the
Compliance Demonstration Packet that
offers states the opportunity to propose
their approach to demonstrating
compliance based on how their CCDF
program is administered. OCC also
consulted other federal programs and
monitoring experts on the Onsite
Monitoring System’s development and
Instrument
Total number
of respondents
Number of
responses per
respondent
17
17
1
1
Compliance Demonstration Chart ....................................................................
Document Submission Chart ...........................................................................
Estimated Total Annual Burden
Hours: 1,632.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: Sec. 658I of the Child Care and
Development Block Grant Act Subpart J of 45
CFR, Part 98 of the Child Care and
Development Fund.
khammond on DSKBBV9HB2PROD with NOTICES
Administration for Children and
Families
[OMB No. 0970–0416]
Mary B. Jones,
ACF/OPRE Certifying Officer.
Submission for OMB Review;
Comment Request
[FR Doc. 2019–10406 Filed 5–17–19; 8:45 am]
Title: 2020 Current Population
Survey-Child Support Supplement.
Description: Collection of these data
will assist legislators and policymakers
BILLING CODE 4184–43–P
incorporated their feedback regarding
the efficiency and efficacy of the
proposed process.
During the development of the Onsite
Monitoring System, OCC conducted
pilots in a number of States. Feedback
received from pilot States and the pilot
results were used to enhance the
monitoring process and data collection
method. Burden estimates below are
based on an analysis of data collected
through all of the pilot visits while
accounting for variance in state
documentation.
Respondents: State grantees and the
District of Columbia.
Annual Burden Estimates:
Respondents will be required to submit
2 separate instruments. First the
Compliance Demonstration Chart will
be submitted and reviewed by ACF–
OCC. For this chart, OCC is looking for
a high-level description of how the state
proposes to demonstrate compliance.
No additional materials should be
submitted with this chart. After review
by OCC, any changes or edits to the
chart will be finalized in collaboration
with the State. Once the final
Compliance Demonstration Chart is
submitted, the State will have 4–6
weeks to complete the Document
Submission Chart and provide the
associated materials.
Average
burden hours
per response
16
80
Annual burden
hours
272
1,360
in determining how effective their
policymaking efforts have been over
time in applying the various child
support legislation to the overall child
support enforcement picture. This
information will help policymakers
determine to what extent individuals on
welfare would be removed from the
welfare rolls as a result of more
stringent child support enforcement
efforts.
Respondents: Individuals and
households.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
2020 Current Population Survey-Child Support Supplement ..........................
41,300
1
0.03
1,239
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Federal Register / Vol. 84, No. 97 / Monday, May 20, 2019 / Notices
Estimated Total Annual Burden
Hours: 1,239.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW, Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: 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. 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.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–10418 Filed 5–17–19; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA), Office of the
Commissioner, Headquarters
organizations, and Centers have
modified their structures.
FOR FURTHER INFORMATION CONTACT:
William Tootle, Director, Office of
Budget, Office of the Commissioner,
Food and Drug Administration, 4041
Powder Mill Rd., Rm. 72094, Beltsville,
MD 20705–4304, 301–796–4710.
SUPPLEMENTARY INFORMATION:
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
I. Introduction
Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970; 60 FR 56606, November 9, 1995;
64 FR 36361, July 6, 1999; 72 FR 50112,
August 30, 2007; 74 FR 41713, August
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16:41 May 17, 2019
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18, 2009; and 76 FR 45270, July 28,
2011) is amended to reflect the
reorganization of the Office of the
Commissioner/FDA Headquarters and
the following Centers: Center for
Devices and Radiological Health
(CDRH), Center for Drug Evaluation and
Research (CDER), Center for Food Safety
and Applied Nutrition (CFSAN), Center
for Tobacco Products (CTP), and Center
for Veterinary Medicine (CVM).
The Office of the Commissioner
reorganization will transition FDA away
from the Directorate structure.
Abolishing the current directorate
structure and realigning many of those
functions to the Centers/Office of
Regulatory Affairs (ORA) establishes a
direct line of communication between
the Centers/ORA and the Commissioner
of Food and Drugs. This direct report
relationship with the Centers
streamlines communications and better
positions FDA to support its regulatory
programs and mission. The intent is to
create a more effective structure that
better reflects FDA’s priorities and
streamlines operations.
The CDRH reorganization will more
accurately reflect the functions
performed by the Center and help to
enhance CDRH’s ability to advance
FDA’s mission and streamline
operations and support functions.
The CDER reorganization changes the
organizational structures and revises the
functional statements of following
organizations: Office of Communication
(OCOMM), Office of Compliance (OC),
Office of Executive Programs (OEP),
Office of Hematology and Oncology
Products (OHOP), and Office of New
Drugs (OND). The proposed
organizational changes will enhance
CDER’s ability to develop, coordinate,
and evaluate public health
communication and education activities
in support of the following:
The CDER Office of Compliance
proposed structure change will establish
the framework for a stronger regulatory
oversight of the compounded human
drugs facilities and compounding
related activities. The new structure will
help ensure the following: That
compounding pharmacies operate
within the bounds of traditional
pharmacy practice (not manufacturing);
that outsourcing facilities operate
according to the conditions in section
503B; and the new structure will protect
patients from unsafe or ineffective
compounded drugs.
The CDER Office of Communication is
planning to expand CDER’s
communications outreach and
educational efforts to inform the
conversation among FDA’s stakeholders.
This will be managed through accessing
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more communication channels,
enhancing FDA’s social media presence,
and using more innovative tools. The
impact of CDER’s growth has impacted
the volume of information posted on the
web as the content management and
development of tools used to connect
stakeholders with web content are
created. As new programs and
initiatives are developed by the Center,
the web content will increase. The new
content management system will
provide the Agency with the
opportunity to finally have a true
publishing tool. This will allow greater
speed in posting the content in the web
environment.
The CDER Office of Executive
Programs houses all the executive
functions for CDER and ensures the
goals and priorities of the Center
Director are carried out. These functions
range from administrative support for
the Center Director’s Office, overseeing
the Center’s learning and organizational
development program, to managing the
Center’s 18 different Advisory
Committees. Restructuring these
functions into defined organizational
structures will improve decision making
by promoting the direct flow of
information from frontline employees to
the managers directly responsible for
making decisions and provide clarity to
staff roles and responsibilities.
Furthermore, the proposed
organizational changes permit Office of
Executive Programs’ managers to better
define critical business processes and
identify opportunities for streamlining
complex tasks, which will facilitate a
more efficient and strategic deployment
of these resources during public health
emergencies and outbreaks. The
proposed changes align with Reimagine
HHS guiding principle #3—Generating
Efficiencies through Streamlined
Processes and Reimagine HHS guiding
principle #5—HHS as a More Innovative
and Responsive Organization.
The CDER Office of Hematology and
Oncology Products reorganization is in
response to Title III of the 21st Century
Cures Act (Cures Act), enacted into law
on December 13, 2016, which provides
authorities FDA can use to help
modernize drug, biological, and device
product development and review to
create greater efficiencies and
predictability in product development
and review. Numerous initiatives are
currently taking place in the Agency to
carry out the plan laid out in the Cures
Act and include: Patient Focused Drug
Development; Novel Clinical Trial
Design; Real World Evidence; Summarylevel Review and Inter-Center Institutes;
as well as other initiatives. The Office
of Hematology and Oncology Products
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[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Notices]
[Pages 22853-22854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10418]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[OMB No. 0970-0416]
Submission for OMB Review; Comment Request
Title: 2020 Current Population Survey-Child Support Supplement.
Description: Collection of these data will assist legislators and
policymakers in determining how effective their policymaking efforts
have been over time in applying the various child support legislation
to the overall child support enforcement picture. This information will
help policymakers determine to what extent individuals on welfare would
be removed from the welfare rolls as a result of more stringent child
support enforcement efforts.
Respondents: Individuals and households.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
2020 Current Population Survey-Child Support 41,300 1 0.03 1,239
Supplement.................................
----------------------------------------------------------------------------------------------------------------
[[Page 22854]]
Estimated Total Annual Burden Hours: 1,239.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 330 C Street SW,
Washington, DC 20201. Attention Reports Clearance Officer. All requests
should be identified by the title of the information collection. Email
address: [email protected].
OMB Comment: 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. 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.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-10418 Filed 5-17-19; 8:45 am]
BILLING CODE 4184-41-P
