Proposed Information Collection Activity; Replication of Recovery and Reunification Interventions for Families-Impact Study (New Collection), 37067-37068 [2023-11989]
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Federal Register / Vol. 88, No. 108 / Tuesday, June 6, 2023 / Notices
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10453 Medicare Advantage and
Prescription Drug Programs: Part C and
Part D Explanation of Benefits
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
ddrumheller on DSK120RN23PROD with NOTICES1
Information Collection
1. Type of Information Collection
Request: Reinstatement with change of
the previously approved collection;
Title of Information Collection:
Medicare Advantage and Prescription
Drug Programs: Part C and Part D
Explanation of Benefits; Use: Sections
1852(k)(2)(C)(i) and 1860D–(4)(a)(4) of
the Act give CMS authority to require
EOBs in MA and Part D, respectively.
Corresponding MA and Part D
regulations at 42 CFR 422.111(k) and
423.128(e) further specify the
requirements to provide a written EOB
directly to enrollees following their use
of benefits.
These requirements and the CMS
model documents help ensure that MA
and Part D enrollees receive consistent
and timely information about costs
associated with their medical claims.
Part C and Part D EOBs allow enrollees
to track their out-of-pocket expenses
and benefit utilization in relation to
their plan’s deductible and out-ofpocket threshold. This customized
information positions enrollees to make
informed decisions about their
healthcare options. It also enables them
to make a more practical use of the
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19:24 Jun 05, 2023
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information found in plans’ Annual
Notice of Change and Evidence of
Coverage documents, as well as
information available through tools such
as the Medicare Plan Finder.
MAOs and Part D sponsors use the
model documents attached to this
information collection to set up the EOB
templates in their systems and ensure
that EOBs conform with the
requirements at 42 CFR 422.111(k) and
423.128(e). MAOs and Part D sponsors
populate EOBs to reflect individual
enrollee benefits under the plan. CMS
issues model EOBs annually through the
Health Plan Management System
(HPMS). Form Number: CMS–10453
(OMB control number: 0938–1228);
Frequency: Monthly; Affected Public:
Private Sector, Business or other forprofits and Not-for-profit institutions;
Number of Respondents: 1,065; Total
Annual Responses: 1,065; Total Annual
Hours: 10,650. (For policy questions
regarding this collection contact Valerie
Yingling at 667–290–8657.)
Dated: June 1, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–11996 Filed 6–5–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Replication of Recovery and
Reunification Interventions for
Families-Impact Study (New
Collection)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, Department of
Health and Human Services.
ACTION: Request for public comments.
AGENCY:
The Administration for
Children and Families (ACF) is
proposing a data collection activity as
part of the Replication of Recovery and
Reunification Interventions for
Families-Impact Study (R3-Impact). The
R3-Impact Study aims to satisfy the
legislative requirements called for by
the 2018 SUPPORT for Patients and
Communities Act by replicating and
testing the efficacy of two recovery
coaching interventions for families
engaged in the child welfare system due
to parental substance use disorders.
DATES: Comments due within 60 days of
publication. In compliance with the
SUMMARY:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
37067
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
You can obtain copies of the
proposed collection of information and
submit comments by emailing
OPREinfocollection@acf.hhs.gov.
Identify all requests by the title of the
information collection.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Description: The R3-Impact study will
use experimental and quasiexperimental designs to test the
effectiveness of the recovery coaching
interventions on key child welfare and
parent well-being outcomes. The
implementation study will document
the fidelity of program implementation,
describe the services participants
receive under each approach, and
provide operational lessons gathered
directly from practitioners. These goals
represent ACF’s interest in
understanding whether recovery
coaching interventions yield successful
parental recovery and child welfare
outcomes, and if so, whether the
potential exists to scale the
interventions for the benefit of more
affected families. The proposed
information collection activity consists
of (1) Baseline data collection:
collection of baseline demographic and
parent well-being data from study
participants; (2) Contact form: short
form sent to study participants quarterly
for one year after study enrollment to
keep contact information current and
generally maintain the participant’s
connection to the study; (3) Validation
interviews: short interviews with a
subset of study participants to monitor
the quality of data collection interviews
and to validate that the interviewer
spoke with the participant; (4)
Implementation study interviews: using
topic guides, collect information from
program supervisors and frontline staff,
community providers, child welfare
staff, and parents enrolled in the
programs to assess the fidelity of
implementation, document program
services, and gather operational lessons;
and (5) Parent Interview Information
Form: demographic information to
support analysis of parent perspectives
by personal characteristics and history.
Future information collection requests
will be submitted to collect follow-up
data.
Respondents: Parents enrolled in the
R3-Impact Study, and program and
agency staff involved in implementing
the R3 interventions.
E:\FR\FM\06JNN1.SGM
06JNN1
37068
Federal Register / Vol. 88, No. 108 / Tuesday, June 6, 2023 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
(total over
request
period)
Instrument
Baseline Parent Survey .......................................................
Contact Form .......................................................................
Topic Guide—Child Welfare Lead Staff ..............................
Topic Guide—Child Welfare Frontline Staff ........................
Topic Guide—Partners ........................................................
Topic Guide—Program Managers .......................................
Topic Guide—Mentor Supervisors .......................................
Topic Guide—Parent/Family Mentors ..................................
Topic Guide—Parents ..........................................................
Parent Interview Information Form ......................................
Validation Interviews ............................................................
Estimated Total Annual Burden
Hours: 1,294.
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: The Substance UseDisorder Prevention that Promotes
Opioid Recovery and Treatment for
Patients and Communities Act.
(SUPPORT for Patients and
Communities Act; Public Law 115–271)
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–11989 Filed 6–5–23; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
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19:24 Jun 05, 2023
Jkt 259001
Number of
responses per
respondent
(total over
request
period)
2,750
1843
60
60
120
60
60
60
30
30
275
1
4
1
1
1
1
1
1
1
1
1
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the award
of the priority review voucher. FDA has
determined that VYJUVEK (beremagene
geperpavec-svdt), manufactured by
Krystal Biotech, Inc., meets the criteria
for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Myrna Hanna, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that VYJUVEK (beremagene geperpavecsvdt), manufactured by Krystal Biotech,
Inc., meets the criteria for a priority
review voucher. VYJUVEK is indicated
for the treatment of wounds in patients
6 months of age and older with
dystrophic epidermolysis bullosa with
mutation(s) in the collagen type VII
alpha 1 chain (COL7A1) gene.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/industry/
developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
Avg. burden
per response
(in hours)
Total burden
(in hours)
.75
.17
1
1
1
1.5
1.5
1.5
1
.1
.08
Annual burden
(in hours)
2063
1,253
60
60
120
90
90
90
30
3
22
688
418
20
20
40
30
30
30
10
1
7
further information about VYJUVEK, go
to the Center for Biologics Evaluation
and Research’s Approved Cellular and
Gene Therapy Products website at
https://www.fda.gov/vaccines-bloodbiologics/cellular-gene-therapyproducts/approved-cellular-and-genetherapy-products.
Dated: May 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–11907 Filed 6–5–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2008]
Vintage Pharmaceuticals; Withdrawal
of Approval of Abbreviated New Drug
Application for Pemoline Tablets, 18.75
Milligrams, 37.5 Milligrams, and 75
Milligrams
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of abbreviated
new drug application (ANDA) 075328
for pemoline tablets, 18.75 milligrams
(mg), 37.5 mg, and 75 mg, held by
Vintage Pharmaceuticals, 120 Vintage
Dr., Huntsville, AL 35811 (Vintage).
Vintage requested that approval of this
application be withdrawn and has
waived its opportunity for a hearing.
DATES: Approval is withdrawn as of
June 6, 2023.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
SUMMARY:
E:\FR\FM\06JNN1.SGM
06JNN1
]]>Agencies
[Federal Register Volume 88, Number 108 (Tuesday, June 6, 2023)]
[Notices]
[Pages 37067-37068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11989]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Replication of Recovery
and Reunification Interventions for Families-Impact Study (New
Collection)
AGENCY: Office of Planning, Research, and Evaluation, Administration
for Children and Families, Department of Health and Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF) is
proposing a data collection activity as part of the Replication of
Recovery and Reunification Interventions for Families-Impact Study (R3-
Impact). The R3-Impact Study aims to satisfy the legislative
requirements called for by the 2018 SUPPORT for Patients and
Communities Act by replicating and testing the efficacy of two recovery
coaching interventions for families engaged in the child welfare system
due to parental substance use disorders.
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: You can obtain copies of the proposed collection of
information and submit comments by emailing
[email protected]. Identify all requests by the title of
the information collection.
SUPPLEMENTARY INFORMATION:
Description: The R3-Impact study will use experimental and quasi-
experimental designs to test the effectiveness of the recovery coaching
interventions on key child welfare and parent well-being outcomes. The
implementation study will document the fidelity of program
implementation, describe the services participants receive under each
approach, and provide operational lessons gathered directly from
practitioners. These goals represent ACF's interest in understanding
whether recovery coaching interventions yield successful parental
recovery and child welfare outcomes, and if so, whether the potential
exists to scale the interventions for the benefit of more affected
families. The proposed information collection activity consists of (1)
Baseline data collection: collection of baseline demographic and parent
well-being data from study participants; (2) Contact form: short form
sent to study participants quarterly for one year after study
enrollment to keep contact information current and generally maintain
the participant's connection to the study; (3) Validation interviews:
short interviews with a subset of study participants to monitor the
quality of data collection interviews and to validate that the
interviewer spoke with the participant; (4) Implementation study
interviews: using topic guides, collect information from program
supervisors and frontline staff, community providers, child welfare
staff, and parents enrolled in the programs to assess the fidelity of
implementation, document program services, and gather operational
lessons; and (5) Parent Interview Information Form: demographic
information to support analysis of parent perspectives by personal
characteristics and history. Future information collection requests
will be submitted to collect follow-up data.
Respondents: Parents enrolled in the R3-Impact Study, and program
and agency staff involved in implementing the R3 interventions.
[[Page 37068]]
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)
----------------------------------------------------------------------------------------------------------------
Baseline Parent Survey.......... 2,750 1 .75 2063 688
Contact Form.................... 1843 4 .17 1,253 418
Topic Guide--Child Welfare Lead 60 1 1 60 20
Staff..........................
Topic Guide--Child Welfare 60 1 1 60 20
Frontline Staff................
Topic Guide--Partners........... 120 1 1 120 40
Topic Guide--Program Managers... 60 1 1.5 90 30
Topic Guide--Mentor Supervisors. 60 1 1.5 90 30
Topic Guide--Parent/Family 60 1 1.5 90 30
Mentors........................
Topic Guide--Parents............ 30 1 1 30 10
Parent Interview Information 30 1 .1 3 1
Form...........................
Validation Interviews........... 275 1 .08 22 7
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,294.
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: The Substance Use-Disorder Prevention that Promotes
Opioid Recovery and Treatment for Patients and Communities Act.
(SUPPORT for Patients and Communities Act; Public Law 115-271)
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023-11989 Filed 6-5-23; 8:45 am]
BILLING CODE 4184-01-P
