Proposed Information Collection Activity; The Understanding and Expanding the Reach of Home Visiting (HV-REACH) Project (New Collection), 56384-56385 [2024-14949]
Download as PDF
<![CDATA[
56384
Federal Register / Vol. 89, No. 131 / Tuesday, July 9, 2024 / Notices
criteria outlined in statute. Sections
226A of the Act authorizes entitlement
for Medicare Hospital Insurance (Part A)
if the individual with ESRD files an
application for benefits and meets the
requisite contributions through one’s
own employment or the employment of
a related individual to meet the
statutory definition of a ‘‘currently
insured’’ individual outlined in section
214 of the Act. Further, for individuals
who meet the requirements for
premium-free Part A entitlement,
Medicare coverage starts based on the
dates in which the individual started
dialysis treatment or had a kidney
transplant. These statutory provisions
are codified at 42 CFR 406.7(c)(3) and
407.13. Form Number: CMS–43 (OMB
control number: 0938–0080); Frequency:
Once; Affected Public: Individuals and
Households Number of Respondents:
45,200; Total Annual Responses:
45,200; Total Annual Hours: 18,984.
(For policy questions regarding this
collection contact Candace Carter at
410–786–8466 or Candace.Carter@
cms.hhs.gov).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–14956 Filed 7–8–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; The Understanding and
Expanding the Reach of Home Visiting
(HV-REACH) Project (New Collection)
Office of Planning, Research,
and Evaluation, Administration for
AGENCY:
Children and Families, U.S. Department
of Health and Human Services.
ACTION: Request for public comments.
As part of the Understanding
and Expanding the Reach of Home
Visiting (HV-REACH) project, the
Administration for Children and
Families (ACF) within the U.S.
Department of Health and Human
Services is proposing to collect
qualitative data to understand the
features of centralized, coordinated, or
collaborative intake systems used by
seven purposively selected sites that
refer families to early childhood home
visiting (ECHV) programs.
DATES: Comments due September 9,
2024. 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
OPREinfocollection@acf.hhs.gov.
Identify all requests by the title of the
information collection.
SUPPLEMENTARY INFORMATION:
Description: The HV-REACH project
is proposing to conduct seven
qualitative case studies to provide an indepth understanding of centralized
intake systems, including how
centralized intake systems reach
potentially eligible families, and how
staff and families think centralized
intake systems support and expand the
recruitment and enrollment of families
in ECHV programs.
The goals of the study are to
understand (1) the features, strengths,
and challenges of centralized intake
systems that refer to ECHV programs; (2)
how centralized intake systems support
outreach to and enrollment of families
SUMMARY:
in ECHV programs; (3) enrolled families’
experiences with centralized intake
systems.
We will conduct virtual or in person
site visits in seven sites, where a site is
defined as including a centralized
intake organization(s) and one or two
associated home visiting programs. We
will collect documentation related to:
• outreach, enrollment, screening,
and referrals processes and pathways,
and data about the defining
characteristics of centralized intake
systems;
• local contexts and community
needs;
• communication processes and
feedback loops with families and
programs;
• successes and challenges of the
system and opportunities for
improvement or technical assistance;
• home visiting program staff and
family perceptions of centralized intake;
• implementation of centralized
intake;
• staff and family experiences with
outreach and enrollment processes
using centralized intake; and
• staff and family background
characteristics.
Findings will highlight opportunities
for program improvement efforts,
technical assistance, or changes to
centralized intake system processes. We
will disseminate findings in a report,
research briefs, and presentations or
briefings.
Respondents: Centralized intake
administrators and other staff
responsible for overseeing outreach and
enrollment; home visiting program
directors and other staff responsible for
overseeing outreach and enrollment;
home visitors and other staff responsible
for conducting outreach and enrollment;
and families enrolled in home-visiting
programs.
ANNUAL BURDEN ESTIMATES
Number of
respondents
(total over
request period)
lotter on DSK11XQN23PROD with NOTICES1
Instrument
19
Centralized Intake Administrator Screening ............................
On site coordination 1 ..............................................................
Centralized Intake Administrator and Other Staff Interview
Protocol ................................................................................
Document Review Request .....................................................
Home visiting program director and Other Staff Interview
Protocol ................................................................................
Home visitor and Other Staff Interview Protocol .....................
Family interview protocol .........................................................
Participant characteristics form ...............................................
VerDate Sep<11>2014
18:00 Jul 08, 2024
Jkt 262001
PO 00000
Frm 00109
Fmt 4703
Number of
responses per
respondent
(total over
request period)
Average burden
per response
(in hours)
Total/annual
burden (in hours)
14
1
1
0.33
4.0
3
56
42
21
1
1
1.5
0.25
63
5
28
42
42
114
1
1
1
1
1.0
1.0
1.0
0.08
28
42
42
9
Sfmt 4703
E:\FR\FM\09JYN1.SGM
09JYN1
Federal Register / Vol. 89, No. 131 / Tuesday, July 9, 2024 / Notices
56385
ANNUAL BURDEN ESTIMATES—Continued
Instrument
Total Annual Burden .........................................................
Number of
respondents
(total over
request period)
Number of
responses per
respondent
(total over
request period)
Average burden
per response
(in hours)
..............................
..............................
..............................
Total/annual
burden (in hours)
248
1 There
is no instrument associated with this activity, which refers to the time spent by the on-site coordinator (nominated by the home visiting
program director) to help the research team coordinate data collection activities.
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,
section 511 (42 U.S.C. 711), as extended
by the Consolidated Appropriations Act
of 2023 (Pub. L. 117–328) (fiscal years
2023–2027).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–14949 Filed 7–8–24; 8:45 am]
BILLING CODE 41842–77–P
New Animal Drugs for Investigational
Use
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1464]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; New Animal Drugs
for Investigational Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:00 Jul 08, 2024
Jkt 262001
collection of information by August 8,
2024.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0117. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
OMB Control Number 0910–0117—
Extension
This information collection helps
support implementation of Agency
statutory and regulatory requirements
regarding the approval of new animal
drugs. FDA has the authority under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) to approve new animal
drugs. A new animal drug application
(NADA) cannot be approved until,
among other things, the new animal
drug has been demonstrated to be safe
and effective for its intended use(s). In
order to properly test a new animal drug
for an intended use, appropriate
scientific investigations must be
conducted. Under specific
circumstances, section 512(j) of the
FD&C Act (21 U.S.C. 360b(j)) permits
the use of an investigational new animal
drug to generate data to support a
NADA approval. Section 512(j) of the
FD&C Act authorizes us to issue
PO 00000
Frm 00110
Fmt 4703
Sfmt 4703
regulations relating to the
investigational use of new animal drugs.
Our regulations in part 511 (21 CFR
part 511) set forth the conditions for
investigational use of new animal drugs
and require reporting and recordkeeping
to qualify for the exemption from
section 512(a) of the FD&C Act. The
information collected is necessary to
protect the public health. We use the
information to determine that
investigational animal drugs are
distributed only to qualified
investigators, adequate drug
accountability records are maintained,
and edible food products from treated
food-producing animals are safe for
human consumption. We also use the
information collected to monitor the
validity of the studies submitted to us
to support new animal drug approval.
Our regulations require that certain
information be submitted to us in a
‘‘Notice of Claimed Investigational
Exemption for a New Animal Drug’’
(NCIE) to qualify for the exemption and
to control shipment of the new animal
drug and prevent potential abuse. We
also require reporting by importers of
investigational new animal drugs (INDs)
for clinical investigational use in
animals (§ 511.1(b)(9)). The information
provided by the sponsor in the NCIE is
needed to help ensure that the proposed
investigational use of the new animal
drug is safe and that any edible food
will not be distributed without proper
authorization from FDA. Information
contained in an NCIE submission is
monitored under our Bioresearch
Monitoring Program. This program
permits us to monitor the validity of the
studies and to help ensure the proper
use of the drugs is maintained by the
investigators.
Sponsors use eSubmitter, a secure
online, question-based submission tool,
to submit the NCIE electronically
(https://www.fda.gov/industry/fdaesubmitter/cvm-esubmitter-programs).
Description of Respondents:
Respondents to this collection of
information are persons who use new
animal drugs for investigational
purposes. INDs are used primarily by
drug industry firms, academic
institutions, and the government (i.e.,
E:\FR\FM\09JYN1.SGM
09JYN1
]]>Agencies
[Federal Register Volume 89, Number 131 (Tuesday, July 9, 2024)]
[Notices]
[Pages 56384-56385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14949]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; The Understanding and
Expanding the Reach of Home Visiting (HV-REACH) Project (New
Collection)
AGENCY: Office of Planning, Research, and Evaluation, Administration
for Children and Families, U.S. Department of Health and Human
Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: As part of the Understanding and Expanding the Reach of Home
Visiting (HV-REACH) project, the Administration for Children and
Families (ACF) within the U.S. Department of Health and Human Services
is proposing to collect qualitative data to understand the features of
centralized, coordinated, or collaborative intake systems used by seven
purposively selected sites that refer families to early childhood home
visiting (ECHV) programs.
DATES: Comments due September 9, 2024. 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 HV-REACH project is proposing to conduct seven
qualitative case studies to provide an in-depth understanding of
centralized intake systems, including how centralized intake systems
reach potentially eligible families, and how staff and families think
centralized intake systems support and expand the recruitment and
enrollment of families in ECHV programs.
The goals of the study are to understand (1) the features,
strengths, and challenges of centralized intake systems that refer to
ECHV programs; (2) how centralized intake systems support outreach to
and enrollment of families in ECHV programs; (3) enrolled families'
experiences with centralized intake systems.
We will conduct virtual or in person site visits in seven sites,
where a site is defined as including a centralized intake
organization(s) and one or two associated home visiting programs. We
will collect documentation related to:
outreach, enrollment, screening, and referrals processes
and pathways, and data about the defining characteristics of
centralized intake systems;
local contexts and community needs;
communication processes and feedback loops with families
and programs;
successes and challenges of the system and opportunities
for improvement or technical assistance;
home visiting program staff and family perceptions of
centralized intake;
implementation of centralized intake;
staff and family experiences with outreach and enrollment
processes using centralized intake; and
staff and family background characteristics.
Findings will highlight opportunities for program improvement
efforts, technical assistance, or changes to centralized intake system
processes. We will disseminate findings in a report, research briefs,
and presentations or briefings.
Respondents: Centralized intake administrators and other staff
responsible for overseeing outreach and enrollment; home visiting
program directors and other staff responsible for overseeing outreach
and enrollment; home visitors and other staff responsible for
conducting outreach and enrollment; and families enrolled in home-
visiting programs.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Average burden
Instrument respondents respondent (total per response (in Total/annual
(total over over request hours) burden (in hours)
request period) period)
----------------------------------------------------------------------------------------------------------------
Centralized Intake Administrator \1\ 9 1 0.33 3
Screening..........................
On site coordination \1\............ 14 1 4.0 56
Centralized Intake Administrator and 42 1 1.5 63
Other Staff Interview Protocol.....
Document Review Request............. 21 1 0.25 5
Home visiting program director and 28 1 1.0 28
Other Staff Interview Protocol.....
Home visitor and Other Staff 42 1 1.0 42
Interview Protocol.................
Family interview protocol........... 42 1 1.0 42
Participant characteristics form.... 114 1 0.08 9
---------------------------------------------------------------------------
[[Page 56385]]
Total Annual Burden............. ................. ................. ................. 248
----------------------------------------------------------------------------------------------------------------
\1\ There is no instrument associated with this activity, which refers to the time spent by the on-site
coordinator (nominated by the home visiting program director) to help the research team coordinate data
collection activities.
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, section 511 (42 U.S.C.
711), as extended by the Consolidated Appropriations Act of 2023 (Pub.
L. 117-328) (fiscal years 2023-2027).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024-14949 Filed 7-8-24; 8:45 am]
BILLING CODE 41842-77-P
