Proposed Information Collection Activity; Head Start Program Performance Standards (OMB #0970-0148), 25280-25281 [2019-11370]
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25280
Federal Register / Vol. 84, No. 105 / Friday, May 31, 2019 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Total
number of
responses per
respondent
Average
burden hours
per response
Total
burden hours
AIAN Facility Survey ........................................................................................
155
3.5
.1
54.25
Estimated Total Annual Burden
Hours: 54.25.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is 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) 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. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Head Start Program
Performance Standards (OMB #0970–
0148)
Office of Head Start;
Administration for Children and
Families; HHS.
ACTION: Request for public comment.
AGENCY:
Mary B. Jones,
ACF/OPRE Certifying Officer.
The Office Head Start (OHS),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS), is
requesting a three-year extension of the
Head Start Program Performance
Standards (HSPPS) information
collection (OMB #0970–0148, expiration
1/31/2020). There are no changes
requested to these record keeping
requirements.
[FR Doc. 2019–11371 Filed 5–30–19; 8:45 am]
DATES:
Authority: 42 U.S.C 9846.
BILLING CODE 4184–40–P
SUMMARY:
Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
the Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed
collection of information can be
obtained and comments may be
forwarded 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: This information
collection was approved alongside the
final rule for the revised HSPPS on
September 1, 2016. This information
collection is entirely record keeping and
does not contain any standardized
instruments or instructions. For
example, this includes the requirement
that programs maintain a waiting list of
eligible families. There are no changes
to the record keeping requirements
contained in this information collection.
Only minor adjustments were made to
the estimated burden based on updated
enrollment and staff data.
Respondents: Head Start grantees.
ADDRESSES:
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
khammond on DSKBBV9HB2PROD with NOTICES
Record keeping requirement
1301.6(a) ..........................................................................................................
1302.12(k) ........................................................................................................
1302.14(c) ........................................................................................................
1302.16(b) ........................................................................................................
1302.33(a) and (b) ...........................................................................................
1302.33(c)(2) ...................................................................................................
1302.42(a) and (b) ...........................................................................................
1302.42(e) ........................................................................................................
1302.47(b)(7)(iv) ..............................................................................................
1302.53 (b) & (d) .............................................................................................
1302.90(a) ........................................................................................................
1302.90(b)(1)(i)–(iv),(b)(4) ...............................................................................
1302.93(a) ........................................................................................................
1302.94(a) ........................................................................................................
1302.101(a)(4)and 1302.102(b)–(c) ................................................................
1302.102(d)(3) .................................................................................................
1303.12 ............................................................................................................
1303.22–24 ......................................................................................................
1303.42–53 ......................................................................................................
1303.70(c) ........................................................................................................
1303.72(a)(3) ...................................................................................................
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Total
number of
responses per
respondent
3,020
1,054,720
3,020
3,020
1,054,720
294,632
1,054,720
3,020
3,020
3,020
3,020
79,509
26,503
3,020
3,020
110
3,020
956,120
260
200
3,020
E:\FR\FM\31MYN1.SGM
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1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
31MYN1
Average
burden hours
per response
0.70
.166
2.00
5.00
1.00
2.00
0.66
0.50
0.50
0.166
0.50
0.33
0.25
0.166
79.00
10.00
0.166
0.33
40.00
1
2
Total
burden hours
2,114
175,084
6,040
15,100
1,054,720
589,264
696,115
1,510
1,510
501
1,510
26,238
6,626
501
238,580
1,100
501
315,520
10,400
200
6,040
Federal Register / Vol. 84, No. 105 / Friday, May 31, 2019 / Notices
Estimated Total Annual Burden
Hours: 3,149,174.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is 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) 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. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 9836A.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–11370 Filed 5–30–19; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0001]
Improving the Implementation of RiskBased Monitoring Approaches of
Clinical Investigations; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA, we) is
announcing the following pubic
workshop entitled ‘‘Improving the
Implementation of Risk-Based
Monitoring Approaches of Clinical
Investigations.’’ This public workshop is
convened by Duke University’s Robert J.
Margolis, MD, Center for Health Policy
and supported by a cooperative
agreement with FDA. The purpose of
the public workshop is to capture
stakeholder experiences with risk-based
approaches to monitoring of clinical
investigations and gather stakeholder
input on opportunities to further the
implementation of risk-based
approaches to monitoring.
DATES: The public workshop will be
held on July 17, 2019, from 8:30 a.m. to
5 p.m. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the Marriott Marquis
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:42 May 30, 2019
Jkt 247001
Washington, DC at 901 Massachusetts
Ave. NW, in Washington DC. For
additional travel and hotel information,
please refer to the following website:
https://healthpolicy.duke.edu/events/
improving-implementation-risk-basedmonitoring-approaches-clinical-trials.
There will also be a live webcast for
those unable to attend the meeting in
person (see Streaming Webcast of the
Public Workshop).
FOR FURTHER INFORMATION CONTACT:
Raymond Chiang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2232,
Silver Spring, MD 20993, 301–796–
1940, Raymond.Chiang@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
To support greater implementation of
risk-based approaches to monitoring
(RBM) of clinical investigations, FDA
issued draft guidance for industry in
March 15, 2019 (84 FR 9531) entitled ‘‘A
Risk-Based Approach to Monitoring of
Clinical Investigations: Questions and
Answers, ‘‘ which is available at https://
www.fda.gov/media/121479/download.
This draft guidance expands on the
guidance for industry entitled,
‘‘Oversight of Clinical Investigations—A
Risk-Based Approach to Monitoring’’
(August 2013) by providing additional
guidance to facilitate sponsors’
implementation of risk-based
monitoring.
Traditionally, sponsors and research
organizations have depended upon onsite monitoring and 100 percent source
data verification for each clinical site,
an approach that is resource intensive
and may contribute to increased clinical
trial costs. Adoption of RBM could lead
to improvements to human subject
protections, data integrity, and the
efficiency of clinical investigations.
Data suggest that RBM has not yet
been widely implemented. Therefore,
FDA is seeking additional feedback from
stakeholders on the challenges, barriers,
and enablers that might be impacting
the adoption of RBM. The public
workshop addressed in this document is
being held to capture stakeholder
experiences with risk-based approaches
to monitoring of clinical investigations
and to gather stakeholder input on ways
to improve the implementation of riskbased approaches to monitoring.
II. Topics for Discussion at the Public
Workshop
During the public workshop, speakers
and participants will cover a range of
issues related to implementation of riskbased approaches to monitoring. Topics
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25281
for discussion will include, and are not
limited to, challenges to implementation
of RBM, enablers to support
implementation of RBM, and lessons
learned from strategies employed to
implement RBM.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, complete the registration
form at https://healthpolicy.duke.edu/
events/improving-implementation-riskbased-monitoring-approaches-clinicaltrials. Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register online by July 16, 2019, by 5
p.m. Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
registered. If time and space permit,
onsite registration on the day of the
public workshop will be provided
beginning at 8 a.m. We will let
registrants know if registration closes
before the day of the public workshop.
If you need special accommodations
due to a disability, please contact the
Duke-Margolis Center for Health Policy
(phone: 202–791–9561, email:
margolisevents@duke.edu) no later than
July 10, 2019.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast and archived video
footage will be available at the event
website. Persons interested in viewing
the live webcast are encouraged to
register in advance (see Registration).
The live webcast will also be available
at the website above on the day of the
event without preregistration.
Registered webcast participants will be
sent technical system requirements in
advance of the event. It is recommended
that you review these technical system
requirements prior to joining the
streaming webcast of the public
workshop.
FDA has verified the website
addresses in this document, as of the
date this document publishes in the
Federal Register, but websites are
subject to change over time.
Meeting Materials: All event materials
will be provided to registered attendees
via email prior to the workshop and will
be publicly available at the DukeMargolis Center for Health Policy
website: https://healthpolicy.duke.edu/
E:\FR\FM\31MYN1.SGM
31MYN1
]]>Agencies
[Federal Register Volume 84, Number 105 (Friday, May 31, 2019)]
[Notices]
[Pages 25280-25281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11370]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Head Start Program
Performance Standards (OMB #0970-0148)
AGENCY: Office of Head Start; Administration for Children and Families;
HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Office Head Start (OHS), Administration for Children and
Families (ACF), U.S. Department of Health and Human Services (HHS), is
requesting a three-year extension of the Head Start Program Performance
Standards (HSPPS) information collection (OMB #0970-0148, expiration 1/
31/2020). There are no changes requested to these record keeping
requirements.
DATES: Comments due within 60 days of publication. In compliance with
the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995, the Administration for Children and Families is soliciting
public comment on the specific aspects of the information collection
described above.
ADDRESSES: Copies of the proposed collection of information can be
obtained and comments may be forwarded 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:
Description: This information collection was approved alongside the
final rule for the revised HSPPS on September 1, 2016. This information
collection is entirely record keeping and does not contain any
standardized instruments or instructions. For example, this includes
the requirement that programs maintain a waiting list of eligible
families. There are no changes to the record keeping requirements
contained in this information collection. Only minor adjustments were
made to the estimated burden based on updated enrollment and staff
data.
Respondents: Head Start grantees.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number Average burden
Record keeping requirement Total number of responses hours per Total burden
of respondents per respondent response hours
----------------------------------------------------------------------------------------------------------------
1301.6(a)....................................... 3,020 1 0.70 2,114
1302.12(k)...................................... 1,054,720 1 .166 175,084
1302.14(c)...................................... 3,020 1 2.00 6,040
1302.16(b)...................................... 3,020 1 5.00 15,100
1302.33(a) and (b).............................. 1,054,720 1 1.00 1,054,720
1302.33(c)(2)................................... 294,632 1 2.00 589,264
1302.42(a) and (b).............................. 1,054,720 1 0.66 696,115
1302.42(e)...................................... 3,020 1 0.50 1,510
1302.47(b)(7)(iv)............................... 3,020 1 0.50 1,510
1302.53 (b) & (d)............................... 3,020 1 0.166 501
1302.90(a)...................................... 3,020 1 0.50 1,510
1302.90(b)(1)(i)-(iv),(b)(4).................... 79,509 1 0.33 26,238
1302.93(a)...................................... 26,503 1 0.25 6,626
1302.94(a)...................................... 3,020 1 0.166 501
1302.101(a)(4)and 1302.102(b)-(c)............... 3,020 1 79.00 238,580
1302.102(d)(3).................................. 110 1 10.00 1,100
1303.12......................................... 3,020 1 0.166 501
1303.22-24...................................... 956,120 1 0.33 315,520
1303.42-53...................................... 260 1 40.00 10,400
1303.70(c)...................................... 200 1 1 200
1303.72(a)(3)................................... 3,020 1 2 6,040
----------------------------------------------------------------------------------------------------------------
[[Page 25281]]
Estimated Total Annual Burden Hours: 3,149,174.
Comments: The Department specifically requests comments on (a)
whether the proposed collection of information is 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) 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.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 9836A.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-11370 Filed 5-30-19; 8:45 am]
BILLING CODE 4184-01-P
