Submission for OMB Review; Behavioral Interventions To Advance Self-Sufficiency Next Generation (BIAS-NG) (0970-0502), 30718-30720 [2019-13701]
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Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices
• Assembling and sharing an
information base of ‘‘best practices’’ for
helping consumers evaluate health
coverage options.
• Building and leveraging existing
community infrastructures for
information, counseling, and assistance.
• Drawing the program link between
outreach and education, promoting
consumer understanding of health care
coverage choices, and facilitating
consumer selection/enrollment, which
in turn support the overarching goal of
improved access to quality care,
including prevention services,
envisioned under the Affordable Care
Act.
The current members of the Panel as
of May 20, 2019 are: Robert Blancato,
President, Matz, Blancato & Associates;
Dale Blasier, Professor of Orthopaedic
Surgery, Department of Orthopedics,
Arkansas Children’s Hospital; Deborah
Britt, Executive Director of Patient
Services, Piedmont Fayette Hospital;
Deena Chisolm, Associate Professor of
Pediatrics and Public Health, The Ohio
State University College of Medicine,
The Research Institute at Nationwide
Children’s Hospital; Robert Espinoza,
Vice President of Policy,
Paraprofessional Healthcare Institute;
Louise Scherer Knight, Director, Harry J.
Duffey Family Patient and Family
Services Program, Johns Hopkins
Sidney Kimmel Comprehensive Cancer
Center; Cathy Phan, Business
Development Coordinator, Asian
American Health Coalition dba HOPE
Clinic; Kamilah Pickett, Director,
Community Health Compass; Alvia
Siddiqi, Medical Director, Advocate
Physician Partners; and Tobin Van
Ostern, Co-Founder, Young Invincibles
Advisors.
jspears on DSK30JT082PROD with NOTICES
II. Provisions of This Notice
In accordance with section 10(a) of
the FACA, this notice announces a
meeting of the APOE. The agenda for
the July 16, 2019 meeting will include
the following:
• Welcome and listening session with
CMS leadership
• Recap of the previous (April 10, 2019)
meeting
• CMS programs, initiatives, and
priorities
• An opportunity for public comment
• Meeting summary, review of
recommendations, and next steps
Individuals or organizations that wish
to make a 5-minute oral presentation on
an agenda topic should submit a written
copy of the oral presentation to the DFO
at the address listed in the ADDRESSES
section of this notice by the date listed
in the DATES section of this notice. The
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number of oral presentations may be
limited by the time available.
Individuals not wishing to make an oral
presentation may submit written
comments to the DFO at the address
listed in the ADDRESSES section of this
notice by the date listed in the DATES
section of this notice.
III. Security, Building, and Parking
Guidelines
The meeting is open to the public, but
attendance is limited to the space
available. Persons wishing to attend this
meeting must register by contacting the
DFO at the address listed in the
ADDRESSES section of this notice or by
telephone at the number listed in the
FOR FURTHER INFORMATION CONTACT
section of this notice by the date
specified in the DATES section of this
notice. This meeting will be held in a
federal government building, the Hubert
H. Humphrey (HHH) Building;
therefore, federal security measures are
applicable.
The REAL ID Act of 2005 (Pub. L.
109–13) establishes minimum standards
for the issuance of state-issued driver’s
licenses and identification (ID) cards. It
prohibits federal agencies from
accepting an official driver’s license or
ID card from a state for any official
purpose unless the Secretary of the
Department of Homeland Security
determines that the state meets these
standards. Beginning October 2015,
photo IDs (such as a valid driver’s
license) issued by a state or territory not
in compliance with the Real ID Act will
not be accepted as identification to enter
federal buildings. Visitors from these
states/territories will need to provide
alternative proof of identification (such
as a valid passport) to gain entrance into
federal buildings. The current list of
states from which a federal agency may
accept driver’s licenses for an official
purpose is found at https://www.dhs.gov/
real-id-enforcement-brief.
We recommend that confirmed
registrants arrive reasonably early, but
no earlier than 45 minutes prior to the
start of the meeting, to allow additional
time to clear security. Security measures
include the following:
• Presentation of a government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel.
• Inspection, via metal detector or
other applicable means, of all persons
entering the building. We note that all
items brought into HHH Building,
whether personal or for the purpose of
presentation or to support a
presentation, are subject to inspection.
We cannot assume responsibility for
coordinating the receipt, transfer,
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transport, storage, set up, safety, or
timely arrival of any personal
belongings or items used for
presentation or to support a
presentation.
Note: Individuals who are not
registered in advance will not be
permitted to enter the building and will
be unable to attend the meeting.
IV. Collection of Information
This document does not impose
information collection requirements,
that is, reporting, recordkeeping, or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
Authority: Sec. 1114(f) of the Social
Security Act (42 U.S.C. 1314(f)), sec. 222 of
the Public Health Service Act (42 U.S.C.
217a), and sec. 10(a) of Pub. L. 92–463 (5
U.S.C. App. 2, sec. 10(a) and 41 CFR part
102–3).
Dated: June 21, 2019.
Seema Verma,
Administrator Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–13658 Filed 6–26–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Behavioral Interventions To Advance
Self-Sufficiency Next Generation
(BIAS–NG) (0970–0502)
Office of Planning, Research,
and Evaluation; Administration for
Children and Families; HHS.
ACTION: Request for public comment.
AGENCY:
The Office of Planning,
Research, and Evaluation (OPRE) in the
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS)
requests Office of Management and
Budget (OMB) approval to modify the
previously approved pilot generic
clearance (0970–0502) to collect data as
part of rapid cycle testing and
evaluation, in order to inform the design
of interventions informed by behavioral
science and to better understand the
mechanisms and effects of such
interventions. Interventions have been
and will continue to be developed in the
program area domains of Temporary
Assistance for Needy Families (TANF)
and child welfare, and this revision
SUMMARY:
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Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices
would also allow for collection of data
in the Early Head Start/Head Start
program area. These interventions are
intended to improve outcomes for
participants in these programs.
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.
DATES:
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
OPREinfocollection@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.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Description: OPRE is conducting the
Behavioral Interventions to Advance
Self-Sufficiency Next Generation (BIAS–
NG) project. This project uses
behavioral insights to design and test
interventions intended to improve the
efficiency, operations, and efficacy of
human services programs. The BIAS–
NG project is applying and testing
behavioral insights to ACF programs
including TANF and Child Welfare, and
intends to expand these efforts to Early
Head Start/Head Start. This notice is a
revision to a previously approved
collection, which included data
collection to design and test
interventions in the TANF and Child
Welfare domains. Under the approved
pilot generic clearance, OPRE plans to
work with approximately six sites, and
will conduct one or more tests per site,
for a total of approximately 9 tests of
behavioral interventions. At least one of
these sites will be in the newly added
program area of Head Start/Early Head
Start. The design and testing of BIAS–
NG interventions is rapid and, to the
extent possible, iterative. Each specific
intervention is designed in consultation
with agency leaders and launched as
quickly as possible. To maximize the
likelihood that the intervention
produces measurable, significant,
positive effects on outcomes of interest,
rapid cycle evaluation techniques will
be employed in which proximate
outcomes will be measured to allow the
research team to more quickly iterate
and adjust the intervention design,
informing subsequent tests. Due to the
rapid and iterative nature of this work,
OPRE sought and received generic
clearance to conduct this research.
Following standard OMB requirements
for generic clearances, once instruments
requiring burden are tailored to a
specific site and the site’s intervention,
OPRE submits an individual generic
information collection request under
this umbrella clearance. Each request
includes the individual instrument(s), a
justification specific to the individual
information collection, a description of
the proposed intervention, and any
supplementary documents. Each
specific information collection includes
up to two submissions: One submission
for the formative stage research and
another submission for any further data
collection requiring burden during the
testing phase. The type of information to
be collected and the uses of the
information is described in the
supporting statements, found here:
https://www.reginfo.gov/public/do/
PRAViewDocument?ref_nbr=2017070970-005.
This Notice is specific to expanding
the program area domains to include
Early Head Start/Head Start, in addition
to the previously approved domains of
Child Welfare and TANF.
Respondents: (1) Program
Administrators, (2) Program Staff and
(3) Program Clients.
TOTAL BURDEN ESTIMATES
[TANF, CW, Third Domain]
Previously
approved
respondents
for TANF and
CW
Instrument
Total number
of respondents
(TANF, CW,
EHS/HS)
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours with
3rd Domain
Diagnosis and Design
Administrator interviews/focus groups .................................
Staff interviews/focus groups ...............................................
Client interviews/focus groups .............................................
Client survey ........................................................................
Staff Survey .........................................................................
24
48
48
600
120
48
378
348
840
144
1
1
1
1
1
1
1
1
.25
.25
48
378
348
210
36
96
756
696
10,800
600
1
1
1
1
1
1
1
1
.25
.25
96
756
696
2,700
150
Evaluation
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Administrator interviews/focus groups .................................
Staff interviews/focus groups ...............................................
Client interviews/focus groups .............................................
Client survey ........................................................................
Staff Survey .........................................................................
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48
96
96
6,000
120
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Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices
Estimated Total Burden Hours: 5,418.
Authority: 42 U.S.C. 1310.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–13701 Filed 6–26–19; 8:45 am]
BILLING CODE 4184–07–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5372]
Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers;
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Marketing Clearance
of Diagnostic Ultrasound Systems and
Transducers.’’ This final guidance
provides detailed recommendations for
manufacturers seeking marketing
clearance of diagnostic ultrasound
systems and transducers, and includes
guidance describing the types of
modifications to a diagnostic ultrasound
device for which FDA does not intend
to enforce the requirement for a new
premarket notification (510(k)).
DATES: The announcement of the
guidance is published in the Federal
Register on June 27, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
jspears on DSK30JT082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
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comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–5372 for ‘‘Marketing Clearance
of Diagnostic Ultrasound Systems and
Transducers.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
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Fmt 4703
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FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://www.regulations
.gov and insert the docket number,
found in brackets in the heading of this
document, into the ‘‘Search’’ box and
follow the prompts and/or go to the
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Marketing
Clearance of Diagnostic Ultrasound
Systems and Transducers’’ to the Office
of the Center Director, Guidance and
Policy Development, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Shahram Vaezy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4227A, Silver
Spring, MD 20993–0002, 301–796–6242;
or Keith Wear, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 2114, Silver Spring,
MD 20993–0002, 301–796–2538.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance provides detailed
recommendations for manufacturers
seeking marketing clearance of
diagnostic ultrasound systems and
transducers. This guidance supersedes
FDA’s guidance entitled ‘‘Information
for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound
Systems and Transducers’’ dated
September 9, 2008, regarding FDA’s
approach to the regulation of certain
diagnostic ultrasound devices.
In addition to outlining regulatory
approaches for certain diagnostic
ultrasound devices, this guidance
describes the types of modifications to
a diagnostic ultrasound device for
which FDA does not intend to enforce
the requirement for a new 510(k). As
E:\FR\FM\27JNN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 124 (Thursday, June 27, 2019)]
[Notices]
[Pages 30718-30720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13701]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Behavioral Interventions To Advance
Self-Sufficiency Next Generation (BIAS-NG) (0970-0502)
AGENCY: Office of Planning, Research, and Evaluation; Administration
for Children and Families; HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Office of Planning, Research, and Evaluation (OPRE) in the
Administration for Children and Families (ACF), U.S. Department of
Health and Human Services (HHS) requests Office of Management and
Budget (OMB) approval to modify the previously approved pilot generic
clearance (0970-0502) to collect data as part of rapid cycle testing
and evaluation, in order to inform the design of interventions informed
by behavioral science and to better understand the mechanisms and
effects of such interventions. Interventions have been and will
continue to be developed in the program area domains of Temporary
Assistance for Needy Families (TANF) and child welfare, and this
revision
[[Page 30719]]
would also allow for collection of data in the Early Head Start/Head
Start program area. These interventions are intended to improve
outcomes for participants in these programs.
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:
Description: OPRE is conducting the Behavioral Interventions to
Advance Self-Sufficiency Next Generation (BIAS-NG) project. This
project uses behavioral insights to design and test interventions
intended to improve the efficiency, operations, and efficacy of human
services programs. The BIAS-NG project is applying and testing
behavioral insights to ACF programs including TANF and Child Welfare,
and intends to expand these efforts to Early Head Start/Head Start.
This notice is a revision to a previously approved collection, which
included data collection to design and test interventions in the TANF
and Child Welfare domains. Under the approved pilot generic clearance,
OPRE plans to work with approximately six sites, and will conduct one
or more tests per site, for a total of approximately 9 tests of
behavioral interventions. At least one of these sites will be in the
newly added program area of Head Start/Early Head Start. The design and
testing of BIAS-NG interventions is rapid and, to the extent possible,
iterative. Each specific intervention is designed in consultation with
agency leaders and launched as quickly as possible. To maximize the
likelihood that the intervention produces measurable, significant,
positive effects on outcomes of interest, rapid cycle evaluation
techniques will be employed in which proximate outcomes will be
measured to allow the research team to more quickly iterate and adjust
the intervention design, informing subsequent tests. Due to the rapid
and iterative nature of this work, OPRE sought and received generic
clearance to conduct this research. Following standard OMB requirements
for generic clearances, once instruments requiring burden are tailored
to a specific site and the site's intervention, OPRE submits an
individual generic information collection request under this umbrella
clearance. Each request includes the individual instrument(s), a
justification specific to the individual information collection, a
description of the proposed intervention, and any supplementary
documents. Each specific information collection includes up to two
submissions: One submission for the formative stage research and
another submission for any further data collection requiring burden
during the testing phase. The type of information to be collected and
the uses of the information is described in the supporting statements,
found here: https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201707-0970-005.
This Notice is specific to expanding the program area domains to
include Early Head Start/Head Start, in addition to the previously
approved domains of Child Welfare and TANF.
Respondents: (1) Program Administrators, (2) Program Staff and (3)
Program Clients.
Total Burden Estimates
[TANF, CW, Third Domain]
----------------------------------------------------------------------------------------------------------------
Previously
approved Total number Number of Average burden Total burden
Instrument respondents of respondents responses per hours per hours with 3rd
for TANF and (TANF, CW, EHS/ respondent response Domain
CW HS)
----------------------------------------------------------------------------------------------------------------
Diagnosis and Design
----------------------------------------------------------------------------------------------------------------
Administrator interviews/focus 24 48 1 1 48
groups.........................
Staff interviews/focus groups... 48 378 1 1 378
Client interviews/focus groups.. 48 348 1 1 348
Client survey................... 600 840 1 .25 210
Staff Survey.................... 120 144 1 .25 36
----------------------------------------------------------------------------------------------------------------
Evaluation
----------------------------------------------------------------------------------------------------------------
Administrator interviews/focus 48 96 1 1 96
groups.........................
Staff interviews/focus groups... 96 756 1 1 756
Client interviews/focus groups.. 96 696 1 1 696
Client survey................... 6,000 10,800 1 .25 2,700
Staff Survey.................... 120 600 1 .25 150
----------------------------------------------------------------------------------------------------------------
[[Page 30720]]
Estimated Total Burden Hours: 5,418.
Authority: 42 U.S.C. 1310.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-13701 Filed 6-26-19; 8:45 am]
BILLING CODE 4184-07-P
