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 Form name Number 

of respondents 

Number 

responses per 

respondent 

Avg. burden 

per response 

(in hrs.) 

Hospital/Academic Institutions/IRB 

Administrators.

CDC IRB Authorization Agreement for Human Research (for review, completion, and submission to 

CDC).

150 1 1 

Hospital/Academic Institutions/IRB 

Administrators.

Local context survey (for completion and submission 

to CDC).

150 1 2 

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 

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: 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 

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), 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Notices 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 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. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

Core SIPP Program Awardees ......... Implementation Capacity Rubric ...................... 26 1 2 52 

Economic Indicators ......................................... 23 1 1 23 

Recipient-level Group Interviews ..................... 26 1 1.5 39 

Injury Indicators Spreadsheet .......................... 26 1 5 130 

Emergency Department Injury Indicators 

Spreadsheet.

26 1 5 130 

Hospital Discharge Injury Indicators Spreadsheet.26 1 5 130 

Special Emphasis Reports ............................... 26 1 10 260 

Total ........................................... .......................................................................... .................... ........................ .................. 764 


ddrumheller on DSK120RN23PROD with NOTICES1
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) 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: 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) 

795–7333; email Larissa.crossen@

acl.hhs.gov 

SUPPLEMENTARY INFORMATION: 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. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[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. 

SUMMARY: 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: 

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. 


ddrumheller on DSK120RN23PROD with NOTICES1