Proposed Information Collection Activity; Mother and Infant Home Visiting Program Evaluation (MIHOPE): Long-Term Follow-Up, Kindergarten Data Collection (MIHOPE-K) (OMB #0970-0402), 53061-53062 [2021-20798]
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Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices
(SUPPORT) for Patients and
Communities Act Section 1003
Demonstration Evaluation; Use: Section
1003 of the SUPPORT Act authorizes
the Secretary of HHS, in consultation
with the Director of the Agency for
Healthcare Research and Quality
(AHRQ) and the Assistant Secretary for
Mental Health and Substance Use from
the Substance Abuse and Mental Health
Services Administration (SAMHSA), to
conduct a 54-month demonstration
project (hereinafter, ‘‘the
Demonstration’’) which is designed to
increase the capacity of Medicaid
providers to deliver substance use
disorder (SUD) treatment and recovery
services.
Section 1003 also requires an
evaluation of the demonstration. The
evaluation is designed to assess:
• The effectiveness of the
Demonstration in increasing the
capacity of providers participating
under the Medicaid state plan (or a
waiver of such plan) to provide
substance use disorder treatment or
recovery services under such plan (or
waiver);
• The activities carried out under the
planning grants and demonstration
project;
• The extent to which participating
states have achieved the stated goals;
and
• The strengths and limitations of the
planning grants and demonstration
project.
This collection of information request
is intended to satisfy the reporting
requirements, defined in the statute,
regarding the impact of the
Demonstration. The evaluation of the
Demonstration will assess the extent to
which the participating states achieved
the goals they established to increase
substance use treatment or recovery
provider capacity under the Medicaid
program. This includes both the
planning and post-planning periods of
the demonstration, as evaluation during
both phases will enable CMS and
stakeholders to assess the effects of the
additional support provided to states
during the post-planning period,
relative to the planning period only.
Primary data collection will occur in
two rounds in year two and year four of
the evaluation. In both rounds, data
collection will consist of: (1) A survey
of providers in all 15 Planning Grant
states who are eligible to prescribe and/
or administer either buprenorphine or
methadone medication for opioid use
disorder (OUD), and (2) focus groups of
providers in five post-planning period
states (two focus groups per state, with
six to eight participants in each group)
who treat SUD, including OUD.
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The survey will gather information on
provider experiences related to
Medicaid provider enrollment, SUD
service delivery, and changes in OUD
medication treatment, including barriers
and enablers of prescribing and
dispensing.
The focus groups will examine the
impact of key aspects of
implementation, such as perceived
burdens associated with Medicaid
enrollment or MAT delivery, access to
referral placements, value of stateprovided TA, and benefits and
unanticipated outcomes experienced by
providers during the Demonstration.
Form Number: CMS–10786 (OMB
control number: 0938–NEW);
Frequency: Biennial; Affected Public:
Private sector (Business or other forprofits and Not-for-profit institutions);
Number of Respondents: 28,810; Total
Annual Responses: 14,405; Total
Annual Hours: 3,689. (For policy
questions regarding this collection
contact Melanie Brown at 410–786–
1095.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Use Review (DUR) Program; Use: States
must provide for a review of drug
therapy before each prescription is filled
or delivered to a Medicaid patient. This
review includes screening for potential
drug therapy problems due to
therapeutic duplication, drug-disease
contraindications, drug-drug
interactions, incorrect drug dosage or
duration of drug treatment, drug-allergy
interactions, and clinical abuse/misuse.
Pharmacists must make a reasonable
effort to obtain, record, and maintain
Medicaid patient profiles. These profiles
must reflect at least the patient’s name,
address, telephone number, date of
birth/age, gender, history, e.g., allergies,
drug reactions, list of medications, and
pharmacist’s comments relevant to the
individual’s drug therapy.
The States must conduct RetroDUR
which provides for the ongoing periodic
examination of claims data and other
records in order to identify patterns of
fraud, abuse, inappropriate or medically
unnecessary care. Patterns or trends of
drug therapy problems are identified
and reviewed to determine the need for
intervention activity with pharmacists
and/or physicians. States may conduct
interventions via telephone,
correspondence, or face-to-face contact.
Annual reports are submitted to CMS
for the purposes of monitoring
compliance and evaluating the progress
of States’ DUR programs. The
information submitted by States is
reviewed and results are compiled by
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53061
CMS in a format intended to provide
information, comparisons, and trends
related to States’ experiences with DUR.
States benefit from the information and
may enhance their programs each year
based on State reported innovative
practices that are compiled by CMS
from the DUR annual reports.
In this 2021 collection of information
request, we revised certain FFS, MCO,
and Abbreviated MCO survey questions.
While a few questions were added to the
surveys to address GAO (U.S.
Government Accountability Office)
recommendations, other aspects of the
survey changes include grammar and
formatting edits. Overall, we are not
revising our currently approved burden
estimates.
Form Number: CMS–R–153 (OMB
control number: 0938–0659); Frequency:
Yearly, quarterly, and occasionally;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
51; Total Annual Responses: 663; Total
Annual Hours: 41,004. (For policy
questions regarding this collection
contact Mike Forman at 410–786–2666.)
Dated: September 21, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–20727 Filed 9–23–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Mother and Infant Home
Visiting Program Evaluation (MIHOPE):
Long-Term Follow-Up, Kindergarten
Data Collection (MIHOPE–K) (OMB
#0970–0402)
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), in
partnership with the Health Resources
and Services Administration (HRSA),
both of the U.S. Department of Health
and Human Services (HHS), is
proposing to extend data collection
activity as part of the kindergarten
phase of the Mother and Infant Home
Visiting Program Evaluation Long-Term
Follow-Up project (MIHOPE–K). The
purpose of MIHOPE–K is to conduct a
follow-up study that assesses the longterm impact of the Maternal, Infant, and
SUMMARY:
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Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices
Early Childhood Home Visiting
(MIECHV) Program when the
participating children are in
kindergarten. This Federal Register
notice is seeking to extend data
collection for the kindergarten followup. The original Federal Register
notices for the MIHOPE–K data
collection were titled under MIHOPELong-Term Follow-Up (MIHOPE–LT).
DATES: Comments due within 60 days of
publication. In compliance with the
requirements 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: This request for an
extension is to complete the following
data collection activities for MIHOPE–K:
(1) A survey with the child’s primary
caregiver (who will be the mother if she
is available), (2) direct assessments of
child development, (3) surveys with the
child’s teacher, (4) a direct assessment
of the caregiver, (5) videotaped
interactions between the caregiver and
child, (6) a caregiver website to provide
current contact information, (7) state
child welfare records, and (8) school
records. In addition to collecting these
data, the MIHOPE–K project will
continue to maintain up-to-date consent
forms for the collection of
administrative data. Future information
collection requests and related Federal
Register notices will describe future
data collection efforts for this project.
Data collected during the kindergarten
follow-up study is being used to
estimate the effects of MIECHV-funded
programs on the following seven
domains: (1) Maternal health, (2) child
health, (3) child development and
school performance, (4) child
maltreatment, (5) parenting, (6) crime or
domestic violence, and (7) family
economic self-sufficiency.
Respondents: The respondents in this
extension will include 1,391 families
who have not yet participated in the
kindergarten follow-up study activities.
We have assumed that only 25 percent
of respondents will complete the
caregiver website. We will also obtain
child welfare data from 11 MIHOPE
states and school records data from state
and local agencies. We have assumed
that we will obtain data from 11 states
and 5 local education agencies.
ANNUAL BURDEN ESTIMATES
Number of
respondents
(total over
request
period)
Instrument
Number of
responses
per
respondent
(total over
request
period)
Avg. burden
per response
(in hours)
Total burden
(in hours)
Annual
burden
(in hours)
Burden for previously approved, ongoing data collection
Survey of caregivers ............................................................
Direct assessments of children ............................................
Survey of the focal children’s teachers ...............................
Direct assessments of caregivers ........................................
Videotaped caregiver-child interactions ...............................
Caregiver website ................................................................
State child welfare records: data file submission ................
School records: data file submission ...................................
Estimated Total Annual Burden
Hours: 2,983.
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.
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1,391
1,391
1,391
1,391
2,782
348
11
16
1
1
1
1
1
1
2
2
0.99
1.33
0.5
0.17
0.25
0.17
15
22.5
1,377
1,850
696
236
696
59
330
720
Authority: Social Security Act Title V
511 [42 U.S.C. 711]. As extended by the
Bipartisan Budget Act of 2018 (Pub. L.
115–123) through FY22.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary B. Jones,
ACF/OPRE Certifying Officer.
[Docket No. FDA–2021–N–0441]
[FR Doc. 2021–20798 Filed 9–23–21; 8:45 am]
BILLING CODE 4184–74–P
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118
348
30
165
360
Food and Drug Administration
Cardiovascular and Renal Drugs
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Cardiovascular and Renal
Drugs Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
SUMMARY:
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Agencies
[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53061-53062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20798]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Mother and Infant Home
Visiting Program Evaluation (MIHOPE): Long-Term Follow-Up, Kindergarten
Data Collection (MIHOPE-K) (OMB #0970-0402)
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), in
partnership with the Health Resources and Services Administration
(HRSA), both of the U.S. Department of Health and Human Services (HHS),
is proposing to extend data collection activity as part of the
kindergarten phase of the Mother and Infant Home Visiting Program
Evaluation Long-Term Follow-Up project (MIHOPE-K). The purpose of
MIHOPE-K is to conduct a follow-up study that assesses the long-term
impact of the Maternal, Infant, and
[[Page 53062]]
Early Childhood Home Visiting (MIECHV) Program when the participating
children are in kindergarten. This Federal Register notice is seeking
to extend data collection for the kindergarten follow-up. The original
Federal Register notices for the MIHOPE-K data collection were titled
under MIHOPE-Long-Term Follow-Up (MIHOPE-LT).
DATES: Comments due within 60 days of publication. In compliance with
the requirements 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: This request for an extension is to complete the
following data collection activities for MIHOPE-K: (1) A survey with
the child's primary caregiver (who will be the mother if she is
available), (2) direct assessments of child development, (3) surveys
with the child's teacher, (4) a direct assessment of the caregiver, (5)
videotaped interactions between the caregiver and child, (6) a
caregiver website to provide current contact information, (7) state
child welfare records, and (8) school records. In addition to
collecting these data, the MIHOPE-K project will continue to maintain
up-to-date consent forms for the collection of administrative data.
Future information collection requests and related Federal Register
notices will describe future data collection efforts for this project.
Data collected during the kindergarten follow-up study is being
used to estimate the effects of MIECHV-funded programs on the following
seven domains: (1) Maternal health, (2) child health, (3) child
development and school performance, (4) child maltreatment, (5)
parenting, (6) crime or domestic violence, and (7) family economic
self-sufficiency.
Respondents: The respondents in this extension will include 1,391
families who have not yet participated in the kindergarten follow-up
study activities. We have assumed that only 25 percent of respondents
will complete the caregiver website. We will also obtain child welfare
data from 11 MIHOPE states and school records data from state and local
agencies. We have assumed that we will obtain data from 11 states and 5
local education agencies.
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)
----------------------------------------------------------------------------------------------------------------
Burden for previously approved, ongoing data collection
----------------------------------------------------------------------------------------------------------------
Survey of caregivers............ 1,391 1 0.99 1,377 689
Direct assessments of children.. 1,391 1 1.33 1,850 925
Survey of the focal children's 1,391 1 0.5 696 348
teachers.......................
Direct assessments of caregivers 1,391 1 0.17 236 118
Videotaped caregiver-child 2,782 1 0.25 696 348
interactions...................
Caregiver website............... 348 1 0.17 59 30
State child welfare records: 11 2 15 330 165
data file submission...........
School records: data file 16 2 22.5 720 360
submission.....................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 2,983.
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: Social Security Act Title V 511 [42 U.S.C. 711]. As
extended by the Bipartisan Budget Act of 2018 (Pub. L. 115-123) through
FY22.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021-20798 Filed 9-23-21; 8:45 am]
BILLING CODE 4184-74-P