Appendix P. Federal Register Notice

Appendix P. Federal Register Notice

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Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)—Continued
Picots element

Comparators .........................

Outcomes .............................

Time of followup ...................
Setting ..................................
Study design ........................

Inclusion criteria
Noninvasive nonpharmacological therapy: Noninvasive nonpharmacological therapies used for acute pain (exercise [and related therapies], cognitive behavioral therapy, meditation, relaxation, music therapy, virtual reality,
acupuncture, massage, manipulation/mobilization, physical modalities [transcutaneous electrical nerve stimulation, ultrasound, braces, traction, heat, cold]).
Opioid therapy:
a–d. Usual care, another opioid, nonopioid drug, or noninvasive, nonpharmacological therapy.
e. Usual care, another opioid, nonopioid drug, or noninvasive, nonpharmacological therapy, no opioid/nothing prescribed.
f. Reference standard for misuse, opioid use disorder, or overdose; or other benchmarks.
g. Usual care.
h. Not utilizing the factors specified in interventions (h) above.
Nonopioid pharmacological therapy:
Other nonopioid pharmacological therapy or noninvasive nonpharmacological therapy.
Noninvasive nonpharmacological therapy:
Sham treatment, waitlist, usual care, attention control, and no treatment; or other noninvasive nonpharmacological therapy.
Opioid therapy:
a–d, g, i. Pain, function, pain relief satisfaction, and quality of life, harms, adverse events (including withdrawal,
risk of misuse, opioid, opioid use disorder, overdose).
e. Persistent opioid use.
f. Measures of diagnostic accuracy.
h. Opioid prescribing rates.
Nonopioid therapy: Pain, function, pain relief satisfaction, quality of life and quality of life, harms, adverse events,
opioid use.
Noninvasive nonpharmacological therapy: Pain, function, pain relief satisfaction, quality of life and quality of life,
harms, adverse events, opioid use.
<1 day; 1 day to <1 week; 1 week to <2 weeks; 2 weeks to <4 weeks; ≥4 weeks.
Emergency department (initiation of therapy and following discharge), physician’s office, outpatient or inpatient
surgical center, dental clinic or oral surgery center, inpatient (sickle cell only).
All KQs: RCTs; in addition:
e. Cohort studies (for long-term opioid use).
f. studies assessing diagnostic accuracy.
h. cohort studies and before-after studies assessing effects on prescribing rates.

Abbreviations: RCT = randomized controlled trial.
Dated: January 3, 2020.
Virginia Mackay-Smith,
Associate Director, Office of the Director,
AHRQ.

to identify and rigorously evaluate
innovative interventions designed to
promote employment and economic
security among low-income individuals
with complex challenges to
employment. The project will include
an experimental impact study,
descriptive study, and cost study.

[FR Doc. 2020–00104 Filed 1–7–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Data Collection for the Next
Generation of Enhanced Employment
Strategies Project (New Collection)
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) within
the Administration for Children and
Families (ACF) is proposing data
collection activities conducted for the
Next Generation of Enhanced
Employment Strategies (NextGen)
Project. The objective of this project is

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SUMMARY:

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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.

DATES:

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.

ADDRESSES:

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To further
build the evidence around effective
strategies for helping low-income
individuals find and sustain
employment, OPRE is conducting the
NextGen Project. This project will
identify and test up to 10 innovative,
promising employment interventions
designed to help individuals facing
complex challenges secure a pathway
toward economic independence. These
challenges may be physical and mental
health conditions, a criminal history, or
limited work skills and experience. The
project is actively coordinating with the
Building Evidence on Employment
Strategies for Low-Income Families
Project (0970–0537), another OPRE
project focused on strengthening ACF’s
understanding of effective interventions
aimed at supporting low-income
individuals to find jobs, advance in the
labor market, and improve their
economic security. Additionally, the
project is working closely with the
Social Security Administration (SSA) to
incorporate a focus on employmentrelated early interventions for
individuals with current or foreseeable
disabilities who have limited work

SUPPLEMENTARY INFORMATION:

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Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices
history and are potential applicants for
Supplemental Security Income (SSI).
The NextGen Project will use a twophased approach for approval of this
proposed information collection
activity. In Phase 1 (current request) the
research team seeks approval to
formally recruit programs, to administer
the informed consent form and baseline
participant survey, and to collect
identifying and contact information for
study participants. The project intends
for these data collections to be uniform
across programs selected for evaluation
and it does not anticipate that they will
require revisions.
Under Phase 2 of the request, the
project will update the information

collection request for the remaining
instruments to tailor to each program
selected for the evaluation, as needed.
The proposed information collection
activities cover an experimental impact
study, descriptive study, and cost study.
Data collection activities for the impact
study include: (1) Baseline survey and
identifying and contact information data
collection, (2) a first follow-up survey,
and (3) a second follow-up survey. Data
collection activities for the descriptive
study include: (1) Service receipt
tracking; (2) staff characteristics survey;
(3) program leadership survey; (4) semistructured program discussion guide
(conducted with program leaders,
supervisors, partners, staff, and

providers); (5) semi-structured employer
discussion guide (for those
interventions that include an employer
component); and (6) in-depth
participant interviews. Data collection
activities for the cost study include an
Excel-based cost workbook.
Respondents: Program staff, program
partners, employer staff, and
individuals enrolled in the NextGen
Project. Program staff and partners may
include case managers, health
professionals, workshop instructors, job
developers, supervisors, managers, and
administrators. Employers may include
administrators, human resources staff,
and worksite supervisors.

ANNUAL BURDEN ESTIMATES
Annual
number of
respondents

Total number
of respondents

Instrument

Number of
responses per
respondent

Average
burden hours
per response

Annual burden
hours

PHASE 1
Baseline survey & identifying and contact information—
participants .......................................................................
Baseline survey & identifying and contact information—
staff ...................................................................................
Estimated Total Annual Burden Hours, Phase 1: ........

10,000

3,333

1

0.42

1,400

200

67

50

0.42

1,407

........................

........................

........................

........................

2,807

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PHASE 2 ESTIMATES
First follow-up survey—participants .....................................
Second follow-up survey—participants ................................
Service receipt tracking—program staff ..............................
Staff characteristics survey—program staff .........................
Program leadership survey—program leaders ....................
Semi-structured program discussion guide—program leaders .....................................................................................
Semi-structured program discussion guide—program supervisors and partners .....................................................
Semi-structured program discussion guide—program staff,
providers ...........................................................................
Semi-structured employer discussion guide—employers ....
In-depth participant interview guide—participants ...............
Cost workbook—program staff ............................................

8,000
8,000
200
200
50

2,667
2,667
67
67
17

1
1
250
1
1

0.83
0.83
0.08
0.42
0.25

2,214
2,214
1,340
28
4

40

13

1

1.5

20

80

27

1

1.0

27

80
50
200
40

27
17
67
13

1
1
1
1

0.75
1.0
2.0
32.0

20
17
134
416

Estimated Total Annual Burden Hours, Phase 2: ........

........................

........................

........................

........................

6,434

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

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to comments and suggestions submitted
within 60 days of this publication.
Authority: Section 413 of the Social
Security Act, as amended by the FY 2017
Consolidated Appropriations Act, 2017
(Public Law 115–31).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–00107 Filed 1–7–20; 8:45 am]
BILLING CODE 4184–09–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0764]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Animal Feed
Regulatory Program Standards
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing

SUMMARY:

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