Proposed Information Collection Activity; OPRE Data Collection for Supporting Youth To Be Successful in Life (SYSIL) (New Collection), 86569-86570 [2020-28886]
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Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices
vulnerabilities are identified and
resolved.
Authority: 44 U.S.C. 3101.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Seema Verma, having reviewed and
approved this document, authorizes
Lynette Wilson, who is the Federal
Register Liaison, to electronically sign
this document for purposes of
publication in the Federal Register.
Dated: December 22, 2020.
Lynette Wilson,
Federal Register, Centers for Medicare &
Medicaid Services.
[FR Doc. 2020–28795 Filed 12–28–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; OPRE Data Collection for
Supporting Youth To Be Successful in
Life (SYSIL) (New Collection)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF) is
requesting approval from the Office of
Management and Budget (OMB) for a
new data collection. The Supporting
Youth to be Successful in Life study
SUMMARY:
(SYSIL) will build evidence on how to
end homelessness among youth and
young adults with experience in the
child welfare system by continuing
work with an organization who
conducted foundational work as part of
the Youth At-Risk of Homelessness
project (OMB Control Number: 0970–
0445). SYSIL will provide important
information to the field by designing
and conducting a federally led
evaluation of a comprehensive service
model for youth at risk of homelessness.
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,
ACF 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
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.
SUPPLEMENTARY INFORMATION:
Description: The SYSIL evaluation
includes an implementation study and
an impact study, which will use a
rigorous quasi-experimental design that
includes a comparison group. This new
information collection request includes
the baseline and follow-up survey
instruments for the impact study (a
single instrument administered four
times), and discussion guides for
interviews and focus groups and the
Working Alliance Inventory (WAI) for
the implementation study. The data
collected from the baseline and followup surveys will be used to describe the
characteristics of the study sample of
youth, develop models for estimating
program impacts, and determine
program effectiveness by comparing
outcomes between youth in the
treatment (youth receiving the Pathways
program) and control groups. Data from
the interviews and focus groups will
provide a detailed understanding of
program implementation. The study
will also use administrative data from
the child welfare system, homelessness
management information system, and
program providers. Administrative data
will be used in its existing format and
does not impose any new information
collection or recordkeeping
requirements on respondents.
Respondents: The baseline and
follow-up surveys will be administered
to youth in the treatment group (youth
receiving the Pathways program) and
youth in the control group who consent
to participate in the study. Interviews
will be conducted with program
leadership and staff. Focus groups will
be conducted with a subset of youth
who are participating in the study. The
WAI will be completed by Pathways
youth and their caseworkers.
ANNUAL BURDEN ESTIMATES
Number of
respondents
(total over
request
period)
Instrument
SYSIL Youth Survey—Baseline survey ...............................
SYSIL Youth Survey—Follow-up survey 1 (6 months) .......
SYSIL Youth Survey—Follow-up survey 2 (12 months) .....
SYSIL Youth Survey—Follow-up survey 3 (24 months) .....
Interview guide for Pathways sites (treatment sites) ...........
Interview guide for comparison sites ...................................
Focus group discussion guide for Pathways youth (treatment youth) ......................................................................
Focus group discussion guide for comparison youth ..........
Working Alliance Inventory for Pathways youth ..................
Working Alliance Inventory for Pathways case workers .....
Estimated Total Annual Burden
Hours: 485.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
VerDate Sep<11>2014
17:47 Dec 29, 2020
Jkt 253001
Number of
responses per
respondent
(total over
request
period)
Frm 00041
Fmt 4703
Total burden
(in hours)
Annual burden
(in hours)
700
630
595
372
30
30
1
1
1
1
1
1
.5
.5
.5
.5
1.5
1.5
350
315
298
186
45
45
117
105
99
62
15
15
50
50
400
40
1
1
1
10
1.5
1.5
.08
.08
75
75
32
32
25
25
11
11
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,
PO 00000
Avg. burden
per response
(in hours)
Sfmt 4703
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
E:\FR\FM\30DEN1.SGM
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86570
Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Section 105(b)(5) of the Child
Abuse Prevention and Treatment Act
(CAPTA) of 1978 (42 U.S.C. 5106(b)(5)), as
amended by the CAPTA Reauthorization Act
of 2010 (Pub. L. 111–320).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–28886 Filed 12–29–20; 8:45 am]
BILLING CODE 4184–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1804]
Product Labeling for Laparoscopic
Power Morcellators; 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 ‘‘Product Labeling for
Laparoscopic Power Morcellators.’’ This
guidance updates recommended
‘‘Contraindications’’ and ‘‘Warnings’’
information to be included in product
labeling to reflect the state of the science
and available technology regarding use
of laparoscopic power morcellators
(LPMs). These labeling
recommendations are intended to
enhance, but not replace, the physicianpatient discussion of the benefits and
risks of use of LPMs that uniquely
pertain to individual patients.
DATES: The announcement of the
guidance is published in the Federal
Register on December 30, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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
VerDate Sep<11>2014
17:47 Dec 29, 2020
Jkt 253001
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
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–
2014–D–1804 for ‘‘Product Labeling for
Laparoscopic Power Morcellators.’’
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, 240–402–7500.
• 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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.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, 240–402–7500.
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 ‘‘Product Labeling for
Laparoscopic Power Morcellators’’ to
the Office of Policy, 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:
Veronica Price, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2659, Silver Spring,
MD 20993–0002, 301–796–6538.
SUPPLEMENTARY INFORMATION:
I. Background
Following issuance of the 2014
guidance document entitled
‘‘Immediately in Effect Guidance
Document: Product Labeling for
Laparoscopic Power Morcellators,’’ FDA
has continued to consider new scientific
information and the input of
stakeholders. Additional scientific
information is available that stratifies
the risks of an undetected uterine cancer
in women with presumed fibroids based
on age.
FDA also considered scientific
information pertaining to the risk of
spreading benign uterine tissue beyond
the uterus during gynecologic surgeries
E:\FR\FM\30DEN1.SGM
30DEN1
]]>Agencies
[Federal Register Volume 85, Number 250 (Wednesday, December 30, 2020)]
[Notices]
[Pages 86569-86570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28886]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; OPRE Data Collection
for Supporting Youth To Be Successful in Life (SYSIL) (New Collection)
AGENCY: Office of Planning, Research, and Evaluation, Administration
for Children and Families, HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF) is
requesting approval from the Office of Management and Budget (OMB) for
a new data collection. The Supporting Youth to be Successful in Life
study (SYSIL) will build evidence on how to end homelessness among
youth and young adults with experience in the child welfare system by
continuing work with an organization who conducted foundational work as
part of the Youth At-Risk of Homelessness project (OMB Control Number:
0970-0445). SYSIL will provide important information to the field by
designing and conducting a federally led evaluation of a comprehensive
service model for youth at risk of homelessness.
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, ACF 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: The SYSIL evaluation includes
an implementation study and an impact study, which will use a rigorous
quasi-experimental design that includes a comparison group. This new
information collection request includes the baseline and follow-up
survey instruments for the impact study (a single instrument
administered four times), and discussion guides for interviews and
focus groups and the Working Alliance Inventory (WAI) for the
implementation study. The data collected from the baseline and follow-
up surveys will be used to describe the characteristics of the study
sample of youth, develop models for estimating program impacts, and
determine program effectiveness by comparing outcomes between youth in
the treatment (youth receiving the Pathways program) and control
groups. Data from the interviews and focus groups will provide a
detailed understanding of program implementation. The study will also
use administrative data from the child welfare system, homelessness
management information system, and program providers. Administrative
data will be used in its existing format and does not impose any new
information collection or recordkeeping requirements on respondents.
Respondents: The baseline and follow-up surveys will be
administered to youth in the treatment group (youth receiving the
Pathways program) and youth in the control group who consent to
participate in the study. Interviews will be conducted with program
leadership and staff. Focus groups will be conducted with a subset of
youth who are participating in the study. The WAI will be completed by
Pathways youth and their caseworkers.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per
respondents respondent Avg. burden Total burden Annual burden
Instrument (total over (total over per response (in hours) (in hours)
request request (in hours)
period) period)
----------------------------------------------------------------------------------------------------------------
SYSIL Youth Survey--Baseline 700 1 .5 350 117
survey.........................
SYSIL Youth Survey--Follow-up 630 1 .5 315 105
survey 1 (6 months)............
SYSIL Youth Survey--Follow-up 595 1 .5 298 99
survey 2 (12 months)...........
SYSIL Youth Survey--Follow-up 372 1 .5 186 62
survey 3 (24 months)...........
Interview guide for Pathways 30 1 1.5 45 15
sites (treatment sites)........
Interview guide for comparison 30 1 1.5 45 15
sites..........................
Focus group discussion guide for 50 1 1.5 75 25
Pathways youth (treatment
youth).........................
Focus group discussion guide for 50 1 1.5 75 25
comparison youth...............
Working Alliance Inventory for 400 1 .08 32 11
Pathways youth.................
Working Alliance Inventory for 40 10 .08 32 11
Pathways case workers..........
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 485.
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
[[Page 86570]]
technology. Consideration will be given to comments and suggestions
submitted within 60 days of this publication.
Authority: Section 105(b)(5) of the Child Abuse Prevention and
Treatment Act (CAPTA) of 1978 (42 U.S.C. 5106(b)(5)), as amended by
the CAPTA Reauthorization Act of 2010 (Pub. L. 111-320).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020-28886 Filed 12-29-20; 8:45 am]
BILLING CODE 4184-29-P
