Submission for Office of Management and Budget (OMB) Review; Building Capacity To Evaluate Child Welfare Community Collaborations To Strengthen and Preserve Families (CWCC) Cross-Site Process Evaluation (OMB #0970-0541), 65595-65596 [2022-23673]
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65595
Federal Register / Vol. 87, No. 209 / Monday, October 31, 2022 / Notices
The Administrator of CMS, Chiquita
Brooks-LaSure, 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: October 26, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2022–23640 Filed 10–28–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing
OPREinfocollection@acf.hhs.gov.
Identify all requests by the title of the
information collection.
SUPPLEMENTARY INFORMATION:
Description: The evaluation involves
seven data collection activities. Initial
interviews with Project Directors and
leaders from partner organizations and
initial interviews with staff from lead
and partner organizations have been
completed. This request includes the
remaining five activities:
• Survey Invitee Template: This
template requests the Project Director of
ADDRESSES:
Administration for Children and
Families
Submission for Office of Management
and Budget (OMB) Review; Building
Capacity To Evaluate Child Welfare
Community Collaborations To
Strengthen and Preserve Families
(CWCC) Cross-Site Process Evaluation
(OMB #0970–0541)
Office of Planning, Research,
and Evaluation (OPRE); Administration
for Children and Families (ACF);
Department of Health and Human
Services (HHS).
ACTION: Request for public comments.
AGENCY:
The Administration for
Children and Families at HHS is
requesting an extension to continue data
collection for an evaluation of the
initiative, Community Collaborations to
Strengthen and Preserve Families (also
referred to as Child Welfare Community
SUMMARY:
each CWCC grant to fill out a Survey
Invitee Template to gather contact
information for leaders and staff from
lead and partner organizations who the
evaluation team will invite to complete
the Collaboration Survey (see below).
• Collaboration Survey: This
electronic survey documents
perceptions that leaders and staff from
the CWCC lead and partner
organizations have regarding their
organizational/group processes,
implementation activities, and progress
towards goals. This survey is
administered to staff at all grantee and
partner organizations on an annual basis
during each cohort’s grant period.
• Site Visit Planning Template: Each
project director (or their designee) will
complete a Site Visit Planning Template
to schedule site visit activities prior to
each annual site visit.
• Two Site Visit Discussion Guides:
To systematically document the
approaches and strategies used by the
first two cohorts of CWCC grantees
(fiscal year (FY) 18 and FY 19
awardees), the evaluation team will
conduct follow-up interviews with: (1)
Project Directors from lead grantee
organizations and leaders from partner
organizations, and (2) Staff from the
lead and partner organizations. These
interviews will take place during site
visits. Each grantee will participate in
four site visits in total. As noted above,
the first two have already been
completed.
Respondents: Leadership and staff
from CWCC lead (grantee) organizations
and from partner organizations.
Collaborations [CWCC]). The cross-site
process evaluation will provide insight
to ACF about the various factors that
promote or impede the implementation
of child welfare community
collaborations.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
(over request
period)
Instrument
Cohort 1
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PO 00000
Total burden
(in hours)
Annual burden
(in hours)
12
1
1.5
18
9
36
4
268
4
1
1
1
1
1
1
.5
2
36
4
134
8
18
2
67
4
Data Collection for FY19 grantees
Site Visit Discussion Guide for Project Directors and Leaders from Partner Organizations—Follow-Up Interviews ...
Site Visit Discussion Guide for Staff from Lead and Partner Organizations—Follow-Up Interviews ........................
Survey Invitee Template ......................................................
Annual Collaboration Survey ...............................................
Site Visit Planning Template ................................................
VerDate Sep<11>2014
Average
burden hours
per response
(in hours)
Data Collection for FY 18 grantees
Site Visit Discussion Guide for Project Directors and Leaders from Partner Organizations—Follow-Up Interviews ...
Site Visit Discussion Guide for Staff from Lead and Partner Organizations—Follow-Up Interviews ........................
Survey Invitee Template ......................................................
Annual Collaboration Survey ...............................................
Site Visit Planning Template ................................................
Cohort 2
Number of
responses per
respondent
(total
over request
period)
Frm 00028
Fmt 4703
27
2
1.5
81
41
81
9
990
9
2
2
2
2
1
1
.5
2
162
18
990
36
81
9
495
18
Sfmt 4703
E:\FR\FM\31OCN1.SGM
31OCN1
65596
Federal Register / Vol. 87, No. 209 / Monday, October 31, 2022 / Notices
Estimated Total Annual Burden
Hours: 744.
Authority: Section 105(b)(5) of the
Child Abuse Prevention and Treatment
Act 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. 2022–23673 Filed 10–28–22; 8:45 am]
BILLING CODE 4184–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2396]
Chemistry, Manufacturing, and
Controls Development and Readiness
Pilot Program; Program
Announcement
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the opportunity for a
limited number of applicants to
participate in a Chemistry,
Manufacturing, and Controls (CMC)
Development and Readiness Pilot
(CDRP) program, to facilitate the
expedited CMC development of
products under an investigational new
drug (IND) application, where
warranted, based upon the anticipated
clinical benefit of earlier patient access
to the products. FDA is implementing
this pilot program to facilitate CMC
readiness for selected Center for
Biologics Evaluation and Research
(CBER)- and Center for Drug Evaluation
and Research (CDER)-regulated products
with accelerated clinical development
timelines. To accelerate CMC
development and facilitate CMC
readiness, the pilot features increased
communication between FDA and
sponsors and explores the use of
science- and risk-based regulatory
approaches, such as those described in
FDA guidance, as applicable. This
notice outlines the eligibility criteria
and process for submitting a request to
participate in the pilot.
DATES: Starting April 1, 2023, FDA will
accept requests to participate in the
CDRP program. See the ‘‘Participation’’
section of this document for eligibility
criteria, instructions on how to submit
a request to participate, and selection
criteria and process.
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SUMMARY:
VerDate Sep<11>2014
17:15 Oct 28, 2022
Jkt 259001
FOR FURTHER INFORMATION CONTACT:
Tanya Clayton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4506,
Silver Spring, MD 20903–0002, 301–
796–0871; or Stephen Ripley, 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.
For general questions about the CDRP
Program for CBER: industry.biologics@
fda.hhs.gov.
For general questions about the CDRP
Program for CDER: cder-opq-opro-cradinquiries@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Development programs for CBER- and
CDER-regulated drugs and biologics
intended to diagnose, treat, or prevent a
serious disease or condition where there
is an unmet medical need may have
accelerated clinical development
timelines. Yet marketing applications
for products in expedited development
programs still need to meet FDA’s
approval standards, including
manufacturing facility compliance with
current good manufacturing practice
(CGMP). Products with accelerated
clinical development activities may face
challenges in expediting CMC
development activities to align with the
accelerated clinical timelines.
Successfully expediting CMC readiness
may require additional interactions with
FDA during product development and,
if applicable, warrant the use of scienceand risk-based regulatory approaches
allowing streamlining of CMC
development activities, so that clinical
benefits of earlier patient access to these
products can be realized.
As described in the FDA Prescription
Drug User Fee Act (PDUFA) VII
Commitment Letter for fiscal years (FYs)
2023 through 2027 (Ref. 1), FDA is
implementing the CDRP program to
facilitate CMC readiness for selected
CBER- and CDER-regulated products
with accelerated clinical development
timelines. To accelerate CMC
development and facilitate CMC
readiness, the pilot features increased
communication between FDA and
sponsors and explores the use of
science- and risk-based regulatory
approaches, such as those described in
the FDA guidance for industry entitled
‘‘Expedited Programs for Serious
Conditions—Drugs and Biologics’’ (May
2014) (Ref. 2), as applicable.
Starting in FY 2023, FDA (CBER and
CDER) will conduct a CDRP to facilitate
the CMC development of selected
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
products under INDs which have
expedited clinical development
timeframes, based upon the anticipated
clinical benefits of earlier patient access
to the products. This includes products
with Breakthrough Therapy (BT), Fast
Track (FT), and Regenerative Medicine
Advance Therapy (RMAT) designations.
For sponsors participating in the pilot,
FDA will provide product-specific CMC
advice during product development, to
include two additional CMC-focused
Type B meetings, as well as a limited
number of additional CMC-focused
discussions, based on readiness and
defined CMC milestones. The increased
communication between FDA review
staff and sponsors is intended to ensure
a mutual understanding of approaches
to completing CMC activities, including
what information should be provided at
the appropriate timepoint (i.e., at the
time of new drug application (NDA) or
biologics license application (BLA)
submission, prior to the end of the
review cycle, or post-approval), to
ensure CMC readiness for a marketing
application.
II. Participation
Starting April 1, 2023, FDA will
accept requests to participate in the
CDRP program and select no more than
nine proposals, with approximately two
thirds being CBER-regulated products
and one third CDER-regulated products.
Taking into consideration lessons from
the prior year, FDA will publish in the
Federal Register a notice to announce
pilot programs for each of the 3
following fiscal years. Sponsors who are
interested in participating in the pilot
program should submit a request to
participate in the pilot as an amendment
to their IND. The cover letter should
state ‘‘Request to participate in the CMC
Development and Readiness Pilot.’’
To promote innovation and
understanding in this area, lessons
learned through the pilot may be
presented by FDA (e.g., in a public
workshop) as case studies, including
when the product studied in the pilot
has not yet been approved by FDA. FDA
intends to conduct a public workshop
and issue a strategy document focused
on CMC aspects of expedited
development incorporating lessons from
the CDRP. Participation in the pilot
program is voluntary and at the
discretion of the sponsor. To be eligible
for the pilot, the sponsor’s written
request should include the following
statement:
‘‘We, <sponsor’s name>, acknowledge that
certain information relevant to the CDRP may
be publicly disclosed.’’
E:\FR\FM\31OCN1.SGM
31OCN1
]]>Agencies
[Federal Register Volume 87, Number 209 (Monday, October 31, 2022)]
[Notices]
[Pages 65595-65596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23673]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for Office of Management and Budget (OMB) Review;
Building Capacity To Evaluate Child Welfare Community Collaborations To
Strengthen and Preserve Families (CWCC) Cross-Site Process Evaluation
(OMB #0970-0541)
AGENCY: Office of Planning, Research, and Evaluation (OPRE);
Administration for Children and Families (ACF); Department of Health
and Human Services (HHS).
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families at HHS is
requesting an extension to continue data collection for an evaluation
of the initiative, Community Collaborations to Strengthen and Preserve
Families (also referred to as Child Welfare Community Collaborations
[CWCC]). The cross-site process evaluation will provide insight to ACF
about the various factors that promote or impede the implementation of
child welfare community collaborations.
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.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. You can
also obtain copies of the proposed collection of information by
emailing [email protected]. Identify all requests by the
title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The evaluation involves seven data collection
activities. Initial interviews with Project Directors and leaders from
partner organizations and initial interviews with staff from lead and
partner organizations have been completed. This request includes the
remaining five activities:
Survey Invitee Template: This template requests the
Project Director of each CWCC grant to fill out a Survey Invitee
Template to gather contact information for leaders and staff from lead
and partner organizations who the evaluation team will invite to
complete the Collaboration Survey (see below).
Collaboration Survey: This electronic survey documents
perceptions that leaders and staff from the CWCC lead and partner
organizations have regarding their organizational/group processes,
implementation activities, and progress towards goals. This survey is
administered to staff at all grantee and partner organizations on an
annual basis during each cohort's grant period.
Site Visit Planning Template: Each project director (or
their designee) will complete a Site Visit Planning Template to
schedule site visit activities prior to each annual site visit.
Two Site Visit Discussion Guides: To systematically
document the approaches and strategies used by the first two cohorts of
CWCC grantees (fiscal year (FY) 18 and FY 19 awardees), the evaluation
team will conduct follow-up interviews with: (1) Project Directors from
lead grantee organizations and leaders from partner organizations, and
(2) Staff from the lead and partner organizations. These interviews
will take place during site visits. Each grantee will participate in
four site visits in total. As noted above, the first two have already
been completed.
Respondents: Leadership and staff from CWCC lead (grantee)
organizations and from partner organizations.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of
Total number responses per Average
of respondents respondent burden hours Total burden Annual burden
Instrument (over request (total over per response (in hours) (in hours)
period) request (in hours)
period)
----------------------------------------------------------------------------------------------------------------
Cohort 1 Data Collection for FY 18 grantees
----------------------------------------------------------------------------------------------------------------
Site Visit Discussion Guide for 12 1 1.5 18 9
Project Directors and Leaders
from Partner Organizations--
Follow-Up Interviews...........
Site Visit Discussion Guide for 36 1 1 36 18
Staff from Lead and Partner
Organizations--Follow-Up
Interviews.....................
Survey Invitee Template......... 4 1 1 4 2
Annual Collaboration Survey..... 268 1 .5 134 67
Site Visit Planning Template.... 4 1 2 8 4
----------------------------------------------------------------------------------------------------------------
Cohort 2 Data Collection for FY19 grantees
----------------------------------------------------------------------------------------------------------------
Site Visit Discussion Guide for 27 2 1.5 81 41
Project Directors and Leaders
from Partner Organizations--
Follow-Up Interviews...........
Site Visit Discussion Guide for 81 2 1 162 81
Staff from Lead and Partner
Organizations--Follow-Up
Interviews.....................
Survey Invitee Template......... 9 2 1 18 9
Annual Collaboration Survey..... 990 2 .5 990 495
Site Visit Planning Template.... 9 2 2 36 18
----------------------------------------------------------------------------------------------------------------
[[Page 65596]]
Estimated Total Annual Burden Hours: 744.
Authority: Section 105(b)(5) of the Child Abuse Prevention and
Treatment Act 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. 2022-23673 Filed 10-28-22; 8:45 am]
BILLING CODE 4184-29-P
