Submission for OMB Review: Assessing Models of Coordinated Services for Low-Income Children and Their Families (AMCS) (New Collection), 49305-49306 [2019-20307]

Download as PDF Federal Register / Vol. 84, No. 182 / Thursday, September 19, 2019 / Notices (e) Photodynamic therapy (f) Irreversible electroporation (5) Whole gland therapies (a) Brachytherapy (b) Cryotherapy (c) External beam radiation therapy (i) three-dimensional conformal radiotherapy (ii) intensity-modulated radiation therapy (iii) proton beam therapy (iv) stereotactic body radiation therapy (d) Radical prostatectomy (i) open (ii) laparoscopic (1) without robotic assistance (2) with robotic assistance (6) Combination of above KQ 2: How do patient characteristics modify comparative effectiveness and harms of CLPC therapies? (1) Age (2) Race/ethnicity (3) Comorbidities (4) Health status KQ 3: How do tumor characteristics modify comparative effectiveness and harms of CLPC therapies? (1) Baseline PSA (2) Gleason score (3) Tumor index scores (e.g., Cancer of the Prostate Risk Assessment Score [CAPRA], D’Amico Risk Classification for Prostate Cancer, etc.) (4) Biomarker Status (a) Decipher (Genomic Classifier) (b) Oncotype Dx (Genomic Prostate Score) (c) Prolaris (Cell Cycle Progression) KQ 4: How do provider/hospital characteristics modify comparative effectiveness of RP compared to other therapies? (1) Geographic region (2) Hospital type (3) Provider volume (4) Institutional volume PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) Interventions KQ1 to 3 jbell on DSK3GLQ082PROD with NOTICES (1) Radical prostatectomy (RP) Comparators KQ1 to KQ4 • Any other intervention of listed above except certain within category comparisons (e.g., nerve-sparing vs non-nerve sparing prostatectomy; different dosage/frequency/timing/ duration of same therapy) (1) Watchful waiting (WW) (2) Active surveillance (AS) (3) Androgen deprivation therapy (ADT) (4) Focal therapies (a) Brachytherapy (b) Cryotherapy (c) High-intensity focused ultrasound Jkt 247001 KQ1 to KQ3 • Overall survival/mortality • Prostate cancer specific survival/ mortality • Metastatic-progression free survival • Metastases (lymph nodes/distant) • Health status • Quality of life (measured with validated instruments) • Prostate-cancer related quality of life (measured with validated instruments) KQ4 • Overall survival/mortality • Prostate cancer specific survival/ mortality • Metastatic free survival/metastases (lymph nodes/distant) Common and serious treatment side effects: • Bowel, bladder, and sexual/erectile dysfunction • Serious adverse effects associated with ADT such as cognitive impairment, MACE, fractures Timing KQ1 to KQ3 Follow up from treatment initiation: PO 00000 Frm 00061 • Mortality/survival outcomes/ metastases: 5 years or more • Health status, quality of life and harms: 1 year or more KQ4 Follow up from treatment initiation: • Mortality/survival outcomes/ metastases: 5 years or more Setting KQ1 to KQ4 • All settings Study Design KQ1 to KQ4 (1) RCTs (2) Non-RCT if: (a) Comparative (b) Concurrent (c) Multicenter (enrolling patients treated at multiple locations) (d) ≥500 patients (e) Some method to control for selection bias (propensity scores, instrumental variables, multivariate regression) (f) Prospective data collection Dated: September 16, 2019. Virginia L. Mackay-Smith, Associate Director. [FR Doc. 2019–20303 Filed 9–18–19; 8:45 am] BILLING CODE 4160–90–P Outcomes KQ1 to KQ3 • Treatment naı¨ve men with CLPC (stages T1 to T3) 17:30 Sep 18, 2019 KQ4 Harms Population(s) VerDate Sep<11>2014 (HIFU) (d) Laser ablation (e) Photodynamic therapy (f) Irreversible electroporation (5) Whole gland therapies (a) Brachytherapy (b) Cryotherapy (c) External beam radiation therapy (i) Three-dimensional conformal radiotherapy (ii) Intensity-modulated radiation therapy (iii) Proton beam therapy (iv) Stereotactic body radiation therapy (d) Radical prostatectomy (i) Open (ii) Laparoscopic (1) Without robotic assistance (2) With robotic assistance (6) Combination of above 49305 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review: Assessing Models of Coordinated Services for Low-Income Children and Their Families (AMCS) (New Collection) Office of Planning, Research, and Evaluation; ACF; HHS ACTION: Request for public comment. AGENCY: The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new study, Assessing Models of Coordinated Services for Low-Income Children and Their Families (AMCS). 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. SUMMARY: E:\FR\FM\19SEN1.SGM 19SEN1 49306 Federal Register / Vol. 84, No. 182 / Thursday, September 19, 2019 / Notices 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 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 should be identified by the title of the information collection. Email address: OPREinfocollection@acf.hhs.gov. SUPPLEMENTARY INFORMATION: Description: Through AMCS, ACF seeks to learn more about how states and communities coordinate early care and education, family economic security, and/or other health and human services to most efficiently and effectively serve the needs of lowincome children and their families. ACF aims to understand strategies used to support partnerships, including the federal barriers to agency collaboration. ADDRESSES: In support of achieving these goals, the study team will conduct site visits to six programs that offer coordinated services. The study team will gather information through interviews with program staff members, such as agency leaders or frontline staff, and focus groups with parents. Data collection activities will include up to six program site visits. Programs will be identified through a scan of publicly available information about programs, recommendations from stakeholders, and proposed telephone interviews (the information collection request for these interviews will be submitted under the generic clearance: Formative Data Collections for ACF Research, OMB #0970–0356)). Once potential programs are identified, agency leaders will be invited to participate in the site visit. Site visits will include semi-structured interviews with up to 30 total staff at each site. Staff invited will include lead program and partner staff to include agency leaders (including program directors, executive directors, or CEOs), directors of programs within the site, frontline staff (including service navigators or coordinators), and focus groups with 8– 10 parents at each site. Semi-structured interviews with program and partner staff will obtain in-depth information about the goals and objectives of programs, the services provided, how the coordinated services are implemented, how staffing is managed, data use, and any facilitators and barriers to coordination. Focus groups with parents participating in the program will provide the opportunity to learn about how parents perceive the program, how it meets their needs, what benefits they gain from the program, and how they enroll, participate, and progress through the program. Respondents: Lead program and partner program staff members working in six programs across the United States that coordinate early care and education services with family economic security services and/or other health and human services, as well as parents receiving services from these programs. Staff respondents will be selected with the goal of having staff represent each level of the organization. Parents who have participated in the program for at least six months and who received early childhood services and at least one other program service will be invited to participate in focus groups. ANNUAL BURDEN ESTIMATES Total/annual number of respondents Instrument Master Interview Protocol ................................................................................ Parent Focus-Group Protocol .......................................................................... Estimated Total Annual Burden Hours: 420. Authority: 42 U.S.C. 9858(a)(5). Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–20307 Filed 9–18–19; 8:45 am] BILLING CODE 4184–23–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration jbell on DSK3GLQ082PROD with NOTICES [Docket No. FDA–2019–D–4048] Safer Technologies Program for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. VerDate Sep<11>2014 17:30 Sep 18, 2019 Jkt 247001 180 60 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Safer Technologies Program for Medical Devices.’’ This draft guidance describes a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. Devices and deviceled combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request (‘‘De Novo request’’), or premarket notification (510(k)). Consistent with the Agency’s statutory mission to protect and promote public health, FDA believes SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden hours per response 1 1 Annual burden hours 2 1 360 60 that this ‘‘Safer Technologies Program’’ or ‘‘STeP’’ will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by November 18, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49305-49306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20307]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review: Assessing Models of Coordinated 
Services for Low-Income Children and Their Families (AMCS) (New 
Collection)

AGENCY: Office of Planning, Research, and Evaluation; ACF; HHS

ACTION: Request for public comment.

-----------------------------------------------------------------------

SUMMARY: The Office of Planning, Research, and Evaluation (OPRE), 
Administration for Children and Families (ACF), U.S. Department of 
Health and Human Services (HHS), is proposing to collect data for a new 
study, Assessing Models of Coordinated Services for Low-Income Children 
and Their Families (AMCS).

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.

[[Page 49306]]


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 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 should be identified by the 
title of the information collection. Email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 
    Description: Through AMCS, ACF seeks to learn more about how states 
and communities coordinate early care and education, family economic 
security, and/or other health and human services to most efficiently 
and effectively serve the needs of low-income children and their 
families. ACF aims to understand strategies used to support 
partnerships, including the federal barriers to agency collaboration. 
In support of achieving these goals, the study team will conduct site 
visits to six programs that offer coordinated services. The study team 
will gather information through interviews with program staff members, 
such as agency leaders or frontline staff, and focus groups with 
parents.
    Data collection activities will include up to six program site 
visits. Programs will be identified through a scan of publicly 
available information about programs, recommendations from 
stakeholders, and proposed telephone interviews (the information 
collection request for these interviews will be submitted under the 
generic clearance: Formative Data Collections for ACF Research, OMB 
#0970-0356)). Once potential programs are identified, agency leaders 
will be invited to participate in the site visit. Site visits will 
include semi-structured interviews with up to 30 total staff at each 
site. Staff invited will include lead program and partner staff to 
include agency leaders (including program directors, executive 
directors, or CEOs), directors of programs within the site, frontline 
staff (including service navigators or coordinators), and focus groups 
with 8-10 parents at each site. Semi-structured interviews with program 
and partner staff will obtain in-depth information about the goals and 
objectives of programs, the services provided, how the coordinated 
services are implemented, how staffing is managed, data use, and any 
facilitators and barriers to coordination. Focus groups with parents 
participating in the program will provide the opportunity to learn 
about how parents perceive the program, how it meets their needs, what 
benefits they gain from the program, and how they enroll, participate, 
and progress through the program.
    Respondents: Lead program and partner program staff members working 
in six programs across the United States that coordinate early care and 
education services with family economic security services and/or other 
health and human services, as well as parents receiving services from 
these programs. Staff respondents will be selected with the goal of 
having staff represent each level of the organization. Parents who have 
participated in the program for at least six months and who received 
early childhood services and at least one other program service will be 
invited to participate in focus groups.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                   Total/annual      Number of        Average
                   Instrument                        number of     responses per   burden  hours   Annual burden
                                                    respondents     respondent     per  response       hours
----------------------------------------------------------------------------------------------------------------
Master Interview Protocol.......................             180               1               2             360
Parent Focus-Group Protocol.....................              60               1               1              60
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 420.

    Authority: 42 U.S.C. 9858(a)(5).

Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-20307 Filed 9-18-19; 8:45 am]
BILLING CODE 4184-23-P