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 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]


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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
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[[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


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