Proposed Data Collection Submitted for Public Comment and Recommendations, 77160-77162 [2024-21570]

Download as PDF 77160 Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Notices Proposed Project Institutional Review Board Authorization Agreement for Human Research—New—Office of Science (OS), Centers for Disease Control and Prevention (CDC). Background and Brief Description The CDC Human Research Protection Office (HRPO) often receives requests from outside institutions seeking to rely on the CDC Institutional Review Board (IRB) for review of a research study. This arrangement also allows multiple institutions to use, or rely on, the CDC IRB for centralized review and approval of research studies instead of review by the site-specific IRBs, which helps reduce duplication of effort, delays, and expenses. To meet regulatory requirements, institutions that elect to rely on the CDC IRB are required to complete a CDC IRB Authorization Agreement for Human Research and a Local Context Survey. The goal is to use the agreement and survey to provide regulatory oversight for human subjects research, to maintain records, and to track those institutions that have elected to rely on the CDC IRB for review. CDC requests OMB approval for an estimated 450 annual burden hours. There is no cost to respondents other than their time to participate. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Hospital/Academic Institutions/IRB Administrators. Hospital/Academic Institutions/IRB Administrators. CDC IRB Authorization Agreement for Human Research (for review, completion, and submission to CDC). Local context survey (for completion and submission to CDC). Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2024–21571 Filed 9–19–24; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–24–1365; Docket No. CDC–2024– 0069] Proposed Data Collection Submitted for Public Comment and Recommendations Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Program Evaluation of CDC’s Core State Injury Prevention Program. This project allows CDC to collect information from awardees funded under the Core State Injury Prevention Program. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:43 Sep 19, 2024 Number of respondents Form name Jkt 262001 CDC must receive written comments on or before November 19, 2024. ADDRESSES: You may submit comments, identified by Docket No. CDC–2024– 0069 by either of the following methods: • Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting comments. • Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21–8, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to www.regulations.gov. Please note: Submit all comments through the Federal eRulemaking portal (www.regulations.gov) or by U.S. mail to the address listed above. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21–8, Atlanta, Georgia 30329; Telephone: 404–639–7570; Email: omb@ cdc.gov. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register DATES: PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 Number responses per respondent Avg. burden per response (in hrs.) 150 1 1 150 1 2 concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and 5. Assess information collection costs. Proposed Project Program Evaluation of CDC’s Core State Injury Prevention Program (OMB Control No. 0920–1365, Exp. 7/31/ 2025)—Revision—National Center for Injury Prevention and Control (NCIPC), E:\FR\FM\20SEN1.SGM 20SEN1 77161 Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Notices Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC is submitting a Revision request for the currently approved Program Evaluation of CDC’s Core State Injury Prevention Program (OMB Control No. 0920–1365, Expiration Date 7/31/2025). Approval is requested for an additional three years to continue collecting information from awardees funded under the Core State Injury Prevention Program cooperative agreement (CE21– 2101), hereafter known as Core SIPP. CDC requests to continue collecting several types of information from recipients over the course of the funding cycle. The Core SIPP Program added three new recipients to the program and is requesting a revision to allow for data collection of these three new recipients. This Revision is requested to incorporate data collection and analysis of three new funded recipients who were added. Data collected up until this point has been used to inform technical assistance (TA) to recipients and programmatic decision-making. CDC has used this data to develop reports to show program impact on recipient capacity, public health actions, and continuous quality improvement. This information will continue to be used to: (1) Evaluate and track outcomes at the recipient- and program-levels as they relate to injury prevention-focused infrastructure development, surveillance system development and use, and partnerships to prevent Adverse Childhood Experiences (ACEs), Traumatic Brain Injury (TBI), and transportation-related injuries. Recipient-and program-level identification of disproportionately affected populations and subsequent public health actions taken to address injury-related health disparities will also be assessed. (2) Identify TA needs of individual recipients and the recipient cohort, so that the CDC team can appropriately deploy resources to support recipients. (3) Identify practice-based evidence for injury prevention public health actions to advance the field through future partnerships, program design, and publications. (4) Inform continuous quality improvement activities over the course of the funding period, to include quarterly and annual strategic planning for current and later iterations of this program under future funding. Information is collected by CDC through the following modes to address the purposes identified above: (1) The Core SIPP Implementation Capacity Development Rubric was implemented once at the start of program funding (baseline collection), and subsequently during the middle of each reporting year. Recipients selfadminister the rubric via CDC’s Partner Portal, where they self-score their state injury prevention programs according to their current level of capacity for components of interest. These scores are used to identify recipient strengths, areas for improvement, and additional needs for CDC TA support. Measuring recipient improvements in implementing public health actions in this standard way greatly increases the ability for CDC to measure the impact of the program investment. CDC aggregates these scores across recipients to identify larger program needs and to inform internal Continuous Quality Improvement (CQI) activities. This information is shared back with recipients individually during annual technical review calls, as well as in aggregate at annual partnership meetings. Additionally, increased capacity will increase the likelihood of sustainability beyond the funding cycle. (2) Recipient-level Group Interviews will take place at the end of Program Years 3, 4, and 5. The purpose of these interviews is to evaluate progress and challenges in implementing the Core SIPP program within the individual recipient-level context to inform tailored supports from CDC and partners. The tailored support is an effort to facilitate solutions to programmatic barriers, adjust recipient strategies as needed, and ensure the quality of data reported annually to CDC. (3) Economic Indicators are collected to better understand the cost of IVP implementation by strategy as well as how recipients have leveraged funds and resources to increased sustainability for injury and violence prevention work. (4) Injury Indicator Spreadsheets and Special Emphasis Reports are collected annually to track state level injury and violence morbidity and mortality data. This allows CDC to measure trends over time within a state, across states, and against the national average to identify changes during the Core SIPP funding period. Completion of the spreadsheets and reports ensures recipient surveillance capacity and reporting is in alignment with best practices. CDC requests OMB approval for an estimated 764 annual burden hours. There is no cost to respondents other than their time to participate. ddrumheller on DSK120RN23PROD with NOTICES1 ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Implementation Capacity Rubric ...................... Economic Indicators ......................................... Recipient-level Group Interviews ..................... Injury Indicators Spreadsheet .......................... Emergency Department Injury Indicators Spreadsheet. Hospital Discharge Injury Indicators Spreadsheet. Special Emphasis Reports ............................... 26 23 26 26 26 1 1 1 1 1 2 1 1.5 5 5 52 23 39 130 130 26 1 5 130 26 1 10 260 .......................................................................... .................... ........................ .................. 764 Type of respondents Form name Core SIPP Program Awardees ......... Total ........................................... VerDate Sep<11>2014 16:44 Sep 19, 2024 Jkt 262001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM 20SEN1 Total burden (in hours) 77162 Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Notices Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2024–21570 Filed 9–19–24; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Announcing the Intent To Award a Sole Source Supplement to the National Association of Councils on Developmental Disabilities (NACDD) Administration for Community Living, HHS. ACTION: Notice. AGENCY: The Administration for Community Living (ACL) is announcing the award of a sole-source supplement for the Bridging Aging and Disability Networks cooperative agreement. ACL’s Office of Supportive and Caregiver Services (OSCS), Administration on Aging (AoA) is collaborating with the Projects of National Significance, the Administration on Disabilities (AoD) to provide a $180,478 supplement to the Bridging Aging and Disability grant. This grant is awarded to the NACDD, who is partnering with the Institute on Disability and Human Development at the University of Illinois-Chicago, the Lurie Institute for Disability Policy at Brandeis University, The Arc, and US Aging—the national association representing and supporting the network of Area Agencies on Aging (AAAs) and Title VI Native American Aging Programs. The goal of the grant is to strengthen the collaboration between aging and disability networks to better support individuals with intellectual and developmental disabilities (I/DD) and their family caregivers in future planning as they age. The supplemental funding will be used to additionally support aging caregivers of adults with I/DD and will enhance the work of the 17 State Consortia teams to more directly build capacity of AAAs to serve adults with I/DD as they age and their aging caregivers. The administrative supplement for FY 2024 will be in the amount of $180,478, bringing the total award for FY 2024 to $600,000.00. FOR FURTHER INFORMATION CONTACT: For further information or comments regarding this program supplement, contact Larissa Crossen, U.S. Department of Health and Human Services, Administration for Community Living, telephone (202) ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 16:44 Sep 19, 2024 Jkt 262001 795–7333; email Larissa.crossen@ acl.hhs.gov DEPARTMENT OF HEALTH AND HUMAN SERVICES The purpose of the supplemental funding is to additionally support aging caregivers of adults with I/DD and will enhance the work of the 17 State Consortia teams. A portion of the funding (estimated 50%) will be used to pay for existing workplan activities of the grantee, particularly where there is overlap in the existing work to bridge the aging and disability networks to support aging caregivers of adults with I/DD. The remainder of the funding (estimated to be 50%) will be used to enhance the work of the 17 State Consortia teams to more directly build capacity of AAAs to serve adults with I/DD as they age and their aging caregivers. Program Name: Bridging Aging and Disabilities Networks. Recipient: NACDD. Period of Performance: The supplement award will be issued for the fourth year of a five-year project period, September 30, 2024, through September 29, 2025. Award Amount: $180,478. Award Type: Cooperative Agreement. Statutory Authority: This program is authorized under the Developmental Disabilities Assistance and Bill of Rights Act of 2000, Title I, Subtitle E. CFDA Number: 93.631 Discretionary Projects. Basis for Award: NACDD is currently funded to carry out the objectives of this project, Bridging Aging and Disability Networks, and has completed three years of work. ACL believes it is in the best interest of the Federal Government to supplement the current grantee’s existing project. Establishing a new grant project at this time would be potentially disruptive to the current work already well under way. Further, it could create unintended duplication of effort and missed opportunities for greater coordination between the aging and disability networks. Food and Drug Administration SUPPLEMENTARY INFORMATION: Dated: September 16, 2024. Alison Barkoff, Principal Deputy Administrator for the Administration for Community Living, performing the delegable duties of the Administrator and the Assistant Secretary for Aging. [FR Doc. 2024–21498 Filed 9–19–24; 8:45 am] BILLING CODE 4154–01–P PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 [Docket No. FDA–2024–D–4165] Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Chemical Analysis for Biocompatibility Assessment of Medical Devices.’’ FDA is issuing this draft guidance to describe recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices. The biocompatibility of medical devices is evaluated based on the duration of exposure and nature of contact with the body. Chemical characterization is one approach that manufacturers can consider when developing a strategy for the overall biocompatibility assessment of a device. This draft guidance is not final nor is it for implementation at this time. DATES: Submit either electronic or written comments on the draft guidance by November 19, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. E:\FR\FM\20SEN1.SGM 20SEN1

Agencies

[Federal Register Volume 89, Number 183 (Friday, September 20, 2024)]
[Notices]
[Pages 77160-77162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21570]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-24-1365; Docket No. CDC-2024-0069]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Program Evaluation of CDC's Core 
State Injury Prevention Program. This project allows CDC to collect 
information from awardees funded under the Core State Injury Prevention 
Program.

DATES: CDC must receive written comments on or before November 19, 
2024.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0069 by either of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.regulations.gov) or by U.S. mail to the address listed 
above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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. In addition, the PRA also requires 
federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses; and
    5. Assess information collection costs.

Proposed Project

    Program Evaluation of CDC's Core State Injury Prevention Program 
(OMB Control No. 0920-1365, Exp. 7/31/2025)--Revision--National Center 
for Injury Prevention and Control (NCIPC),

[[Page 77161]]

Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC is submitting a Revision request for the currently approved 
Program Evaluation of CDC's Core State Injury Prevention Program (OMB 
Control No. 0920-1365, Expiration Date 7/31/2025). Approval is 
requested for an additional three years to continue collecting 
information from awardees funded under the Core State Injury Prevention 
Program cooperative agreement (CE21-2101), hereafter known as Core 
SIPP.
    CDC requests to continue collecting several types of information 
from recipients over the course of the funding cycle. The Core SIPP 
Program added three new recipients to the program and is requesting a 
revision to allow for data collection of these three new recipients. 
This Revision is requested to incorporate data collection and analysis 
of three new funded recipients who were added. Data collected up until 
this point has been used to inform technical assistance (TA) to 
recipients and programmatic decision-making. CDC has used this data to 
develop reports to show program impact on recipient capacity, public 
health actions, and continuous quality improvement. This information 
will continue to be used to:
    (1) Evaluate and track outcomes at the recipient- and program-
levels as they relate to injury prevention-focused infrastructure 
development, surveillance system development and use, and partnerships 
to prevent Adverse Childhood Experiences (ACEs), Traumatic Brain Injury 
(TBI), and transportation-related injuries. Recipient-and program-level 
identification of disproportionately affected populations and 
subsequent public health actions taken to address injury-related health 
disparities will also be assessed.
    (2) Identify TA needs of individual recipients and the recipient 
cohort, so that the CDC team can appropriately deploy resources to 
support recipients.
    (3) Identify practice-based evidence for injury prevention public 
health actions to advance the field through future partnerships, 
program design, and publications.
    (4) Inform continuous quality improvement activities over the 
course of the funding period, to include quarterly and annual strategic 
planning for current and later iterations of this program under future 
funding.
    Information is collected by CDC through the following modes to 
address the purposes identified above:
    (1) The Core SIPP Implementation Capacity Development Rubric was 
implemented once at the start of program funding (baseline collection), 
and subsequently during the middle of each reporting year. Recipients 
self-administer the rubric via CDC's Partner Portal, where they self-
score their state injury prevention programs according to their current 
level of capacity for components of interest. These scores are used to 
identify recipient strengths, areas for improvement, and additional 
needs for CDC TA support. Measuring recipient improvements in 
implementing public health actions in this standard way greatly 
increases the ability for CDC to measure the impact of the program 
investment. CDC aggregates these scores across recipients to identify 
larger program needs and to inform internal Continuous Quality 
Improvement (CQI) activities. This information is shared back with 
recipients individually during annual technical review calls, as well 
as in aggregate at annual partnership meetings. Additionally, increased 
capacity will increase the likelihood of sustainability beyond the 
funding cycle.
    (2) Recipient-level Group Interviews will take place at the end of 
Program Years 3, 4, and 5. The purpose of these interviews is to 
evaluate progress and challenges in implementing the Core SIPP program 
within the individual recipient-level context to inform tailored 
supports from CDC and partners. The tailored support is an effort to 
facilitate solutions to programmatic barriers, adjust recipient 
strategies as needed, and ensure the quality of data reported annually 
to CDC.
    (3) Economic Indicators are collected to better understand the cost 
of IVP implementation by strategy as well as how recipients have 
leveraged funds and resources to increased sustainability for injury 
and violence prevention work.
    (4) Injury Indicator Spreadsheets and Special Emphasis Reports are 
collected annually to track state level injury and violence morbidity 
and mortality data. This allows CDC to measure trends over time within 
a state, across states, and against the national average to identify 
changes during the Core SIPP funding period. Completion of the 
spreadsheets and reports ensures recipient surveillance capacity and 
reporting is in alignment with best practices.
    CDC requests OMB approval for an estimated 764 annual burden hours. 
There is no cost to respondents other than their time to participate.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                            Average
                                                              Number of      Number of    burden per     Total
        Type of respondents                 Form name        respondents   responses per   response   burden (in
                                                                            respondent    (in hours)    hours)
----------------------------------------------------------------------------------------------------------------
Core SIPP Program Awardees.........  Implementation                   26               1           2          52
                                      Capacity Rubric.
                                     Economic Indicators...           23               1           1          23
                                     Recipient-level Group            26               1         1.5          39
                                      Interviews.
                                     Injury Indicators                26               1           5         130
                                      Spreadsheet.
                                     Emergency Department             26               1           5         130
                                      Injury Indicators
                                      Spreadsheet.
                                     Hospital Discharge               26               1           5         130
                                      Injury Indicators
                                      Spreadsheet.
                                     Special Emphasis                 26               1          10         260
                                      Reports.
                                                            ----------------------------------------------------
    Total..........................  ......................  ...........  ..............  ..........         764
----------------------------------------------------------------------------------------------------------------



[[Page 77162]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2024-21570 Filed 9-19-24; 8:45 am]
BILLING CODE 4163-18-P


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