GenIC Request Template Updated

OMB Control Number 0920-1282

Performance Measures Project

Request for genIC Approval (for data collection in 2024, 2025, 2026)

CIO: National Center for Emerging and Zoonotic Infectious Diseases

PROJECT TITLE: HAI/AR Programs

PURPOSE AND USE OF COLLECTION:

Note: This is a request to update select data collection instruments (Forms 1, 2, and 4) with changes that are non-substantive. These minor updates offer some clarifying language, removal of select response options, and an updated burden estimate/number of respondents that reflects reduced burden on respondents.

CDC’s Epidemiology and Laboratory Capacity cooperative agreement (ELC; CK19-1904; performance period from August 2019 to July 2024) provides funding to support and enhance the capacity of local and state health departments. Within ELC, Program G1: Healthcare-associated Infections, Antibiotic Resistance, and Antibiotic Stewardship (hereafter G1) funds a network of Healthcare-Associated Infections (HAIs) & Antibiotic Resistance (AR) Programs within health departments that work to improve patient safety by preventing HAIs, containing emerging AR, and improving use of antibiotics. During the COVID-19 pandemic, CDC received supplemental funding that was distributed through the ELC mechanism to support the HAI/AR programs and their COVID-19 healthcare infection prevention, control, and response efforts. In August 2024, a new 5-year cycle of this cooperative agreement (ELC; CK24-0002; performance period from August 2024 to July 2029) will begin, with Program H: Healthcare-associated Infections, Antibiotic Resistance, and Antibiotic Stewardship (hereafter H) continuing the work of CK19-1904’s G1.

This request for genIC approval is applicable to performance measures reported for all recipients of CK19-1904 G1, CK24-0002 H, and the following COVID-19 supplements that work together to support CDC-funded HAI/AR programs: ELC Firstline Infection Prevention and Control (IPC) Training Supplement (Project Firstline), CARES and Enhancing Detection Expansion (CARES/EDEX), Strengthening HAI/AR Program Capacity (SHARP), and Nursing Home and Long-term Care Strike Team Infrastructure Project (NH Strike Teams). COVID response dollars funded the supplements listed for this genIC request. The broader ELC cooperative agreement may have other PRA packages associated with additional data collections and other performance measurement activities due to the breadth of programs across CDC using the funding mechanism, but the performance measures included in this application are unique to CK19-1904 (G1), CK24-0002 (H), and the other related supplements. The funded activities associated with this request are described in additional detail below:

• G1 (CK19-1904, core funding; performance period of August 2019–July 2024): Provides funds to 59 health departments through the core ELC cooperative agreement to support and enhance the capacity of local and state health departments to improve patient safety by preventing HAIs, containing emerging AR, and improving use of antibiotics.

• H (CK24-0002, core funding; performance period of August 2024–July 2029): Will provide funds to up to 65 health departments through the core ELC cooperative agreement to support and enhance the capacity of local and state health departments to improve patient safety by preventing HAIs, containing emerging AR, and improving use of antibiotics.

• Project Firstline (supplement): Provides HAI/AR Program COVID-19 funding for training of frontline healthcare personnel. To stop the spread of COVID-19 and other infectious diseases, all healthcare personnel need at least a foundational understanding of IPC. Project Firstline, CDC’s national training collaborative on healthcare IPC, includes an innovative IPC training curriculum delivered through a variety of interactive modalities. Health departments will assist in reaching targeted front-line healthcare personnel while also creating IPC training expertise in the public health workforce.

• CARES/EDEX (supplement): As part of the “Coronavirus Aid, Relief, and Economic Security Act” or the “CARES Act” of 2020, in a program-initiated component funding under Project E: Emerging Issues of CK19-1904, funds were awarded to 64 health departments to bolster their HAI/AR program’s ability to rapidly establish and monitor key activities related to COVID-19 in the areas of epidemiology, laboratory, and informatics (CARES). To provide additional critical support to jurisdictions as they continue to address COVID-19 within their communities, funds from the Coronavirus Response and Relief Supplemental Appropriations Act of 2021, P.L. 116-260, provided additional resources to prevent, prepare for, and respond to coronavirus by supporting testing, case investigation and contact tracing, surveillance, containment, and mitigation (Enhancing Detection Expansion).

• SHARP (supplement): Through the American Rescue Plan Act of 2021, P.L. 117-2, as program-initiated component funding under Project E: Emerging Issues of CK19-1904, funds were awarded to 64 health departments’ HAI/AR programs to provide additional critical support to recipients as they continue to address COVID-19 within their communities. SHARP funds were distributed as two supplemental awards, with the first SHARP supplement awarded in 2021 (SHARP-1). In 2023, the remaining SHARP funds were awarded (SHARP-2), along with guidance that is complementary to the original SHARP guidance and includes some adjustments to priorities or activities.

• NH Strike Teams (supplement): Through the American Rescue Plan Act of 2021, P.L. 117-2, as program-initiated component funding under Project E: Emerging Issues of CK19-1904, funds were awarded to 64 health departments to assist recipients with supporting long-term care facilities during their response to SARS-CoV-2 infections, and also to build and maintain the infection prevention infrastructure necessary to support resident, visitor, and facility healthcare personnel safety.

The specific combinations of funds received by each recipient are detailed in the attachment ‘NCEZID - Funding by recipient’.

The purpose of the collection is to assess recipients’ individual and collective progress toward implementing priority activities funded, direct technical assistance (TA) to recipients, and obtain information needed to help assess the awards’ contribution to public health impact. Findings will be disseminated to funded recipients and key CDC staff and partners to be used for internal program improvement and planning and accountability purposes.

NUMBER AND TITLE OF NOFO: CK19-1904, Epidemiology and Laboratory Capacity and supplements; CK24-0002, Epidemiology and Laboratory Capacity

NUMBER OF PARTICIPATING RECIPIENTS: 65

• For CK19-1904: 59 health departments are funded for core ELC, G1, HAI/AR work.

• For CK24-0002: 65 health departments are funded for core ELC, H, HAI/AR work.

• For all remaining supplemental awards associated with this application, 64 health departments are funded for additional HAI/AR and COVID-19 response and prevention work.

DESCRIPTION OF NOFO (check all that apply):

_X_ Funds all 50 states

_X_ Has budget higher than $10 million per year

_X_ Has significant stakeholder interest (e.g. partners, Congress)

Please elaborate:

The ELC cooperative agreement supports critical public health infrastructure by funding and providing technical assistance to up to 65 state, local, and territorial health departments. Through the G1 project within ELC, the Division of Healthcare Quality Promotion (DHQP) awards approximately $33M annually to Healthcare-Associated Infection and Antibiotic Resistance (HAI/AR) programs in state, local, and territorial health departments, to improve patient safety by preventing HAIs, containing emerging AR, and improving use of antibiotics within their communities. Significant supplemental funding went out through ELC/DHQP to further HAI/AR programs’ ability to apply their strategies for patient safety in response to the COVID pandemic. Supplemental funds went to 64 ELC recipients to support COVID-19 healthcare infection prevention and response efforts, including $80M for ELC Project Firstline, $629M for SHARP ($385M for SHARP-1; $244M in SHARP-2), and $500M for NH Strike Teams. Supplemental funds provided through ELC CARES ($631M), Enhancing Detection ($10.25B), and Enhancing Detection Expansion ($19.11B) also supported healthcare infection prevention and control activities and staffing for HAI/AR Programs. Through H, DHQP will award approximately $15M annually to recipient HAI/AR programs. Given the amount of funds awarded and the importance of demonstrating how funds have been used to support state and local public health efforts to respond to COVID-19 and other infectious disease threats, this work has significant stakeholder interest.

PERFORMANCE METRICS USED & JUSTIFICATIONS:

CDC developed the proposed performance measures associated with this application based on the required activities of funded recipients, as outlined in the Notice of Funding Opportunity guidance documents, and priorities defined by each project area as outlined in supplemental guidance. The performance measures primarily focus on the quantitative aspect of measuring recipients’ expected performance; this was done in an effort to balance the burden on recipients and need to track progress and accountability.

Performance measures will be collected annually during the appropriate performance period. Details on the performance periods for each funding award can be found in the attachment ‘NCEZID - Funding performance periods.’ Technical specifications were developed in alignment with previous ELC performance measures, to provide consistency to recipients in how performance measures are presented across the cooperative agreement.

There are a total of 15 performance measures associated with this application. Some measures are shared across funding streams, and some are unique to one (see table below). This reflects the intent of the awards, as supplemental funds were awarded to build upon and strengthen existing infrastructure through increases or improvements to existing activities and new, related activities. Given the relationship of many measures to more than one funding stream, measures have been organized by topic or project area: (1) Response and Prevention, (2) Antibiotic Stewardship, (3) National Healthcare Safety Network (NHSN), and (4) Project Firstline. CDC subject matter experts developed the measures specifically for their project areas, to ensure that the data for each measure are collected in a way that is most appropriate for the specific topic area. Details for each performance measure can be found in the attachment ‘NCEZID - Technical specifications.’ Forms detailing how these data will be collected from recipients can be found in the attached forms (Form 1 through Form 5) and associated recipient notification email (‘NCEZID - Sample Email). The data collection forms are summarized in the attachment ‘NCEZID - Data reporting cover page.’ While the attached forms show every item a respondent could possibly see, respondents will complete the forms on the web-based REDCap application, which will accommodate skip patterns and only show relevant questions to the respondent. Use of the web-based application and skip patterns will significantly streamline the respondent’s user experience and minimize burden to the respondent.

Table: Measures, with frequency and funding stream

Project Area	Performance Measure Number	Frequency of Reporting	Associated Funding Stream
			G1	H	Project Firstline	CARES/ EDEX	SHARP	NH Strike Teams
HAI/AR Response and Prevention (HARP)	HARP PM1	1x/year	X
	HARP 2 (formerly called HARP PM2)	1x/year	X	X			X	X
	HARP 3 (formerly called HARP PM3)	1x/year	X	X		X	X	X
	HARP 4 (formerly called HARP PM4)	1x/year	X	X		X	X	X
	HARP 1 (formerly called HARP PM5 SHARP PM I.1, I.2, Strike PM2)	1x/year		X		X	X	X
	HARP PM6 (formerly called Strike PM1)	2x/year						X
Antibiotic Stewardship	AS 1 (formerly called AS PM1, SHARP PM 3.1)	1x/year		X			X
	AS 2 (formerly called AS PM2, SHARP PM 3.2	1x/year	X	X			X
NHSN	NHSN 1 (formerly called NHSN PM1, SHARP PM IV.1)	1x/year					X
	NHSN 2 (formerly called NHSN PM2, SHARP PM IV.2)	1x/year					X
	NHSN 3 (formerly called NHSN PM3)	1x/year					X
Project Firstline (PFL)	PFL 1 (formerly called PFL PM1)	1x/year		X	X		X
	PFL 2 (formerly called PFL PM2)	1x/year		X	X		X
	PFL 3 (formerly called PFL PM3)	1x/year		X	X
	PFL 4 (formerly called PFL PM4, SHARP PM V.1)	1x/year					X

Five forms will be used: one form for each project area (4) and one cross-cutting staffing form for all projects (1). The project area-specific forms will collect data using REDCap, a secure web application compliant with the Federal Information Security Management Act (FISMA). Health departments are already familiar with REDCap, since it has been used in other ELC activities, which helps to minimize burden. The cross-cutting staffing form will collect data using SharePoint, a secure web application protected by Secure Access Management System (SAMS). Collecting staffing data in SharePoint will allow for a user-friendly data collection experience for the respondent and make the data rapidly available for recipient and CDC use through a shared SharePoint dashboard.

CERTIFICATION:

I certify the following to be true:

1. The collection is non-controversial and does not raise issues of concern to other federal agencies.

2. Information gathered is meant primarily for program improvement and accountability; it is not intended to be used as the principal basis for policy decisions

Name: ___Margaret Paek_____________________________________________

To assist review, please answer the following questions:

ANNUALIZED BURDEN HOURS:

This table calculates the total estimated burden per year for all recipients.

The column “Associated Funding Streams” lists the corresponding funding source(s) for each form. Forms 1 and 3 are described in multiple rows, to delineate (1) differences in frequency of reporting or (2) the number of respondents. Skip patterns in the web-based application ensure that the respondent only sees the minimum number of fields.

Type of Respondent	Form Name	Associated Funding Streams	No. of Respondents	No. of Responses per Respondent	Avg. Burden Per Response (in hours)	Burden in Hours
State, local, or territorial health departments	Form 1 - HAI/AR Response & Prevention Performance Measures 1, 2, 3, 4	G1, H, CARES/EDEX, SHARP, NH Strike Teams	65	1	960/60	1040
State, local, or territorial health departments	Form 2 - HAI/AR Antibiotic Stewardship Performance Measures 1, 2	G1, H, SHARP	65	1	45/60	49
State, local, or territorial health departments	Form 3 - HAI/AR NHSN Performance Measures 1, 2	SHARP	64	1	45/60	48
State, local, or territorial health departments	Form 3 - HAI/AR NHSN Performance Measures 3	SHARP	12	1	25/60	5
State, local, or territorial health departments	Form 4 - HAI/AR Project Firstline Performance Measures 1, 2, 3 ,4	H, Project Firstline, SHARP	65	1	1	65
State, local, or territorial health departments	Form 5 - HAI/AR Program Staffing Directory	G1, H, Project Firstline, CARES/EDEX, SHARP, NH Strike Teams	65	4	78/60	338
Totals						1545

TOTAL BURDEN HOURS FOR THIS GENIC:

This table specifies the calendar years in which information will be collected and calculates the total burden hours requested over the approved timeframe of the generic.

Data Collection Timeframe (List up to 3 Years)	No. Years Requested	Annualized Burden Hours	Total Burden Hours for this GENIC
2024, 2025, 2026	3	1545	4,635

See examples provided with this template.

FEDERAL COST: The estimated annual cost to the Federal government is __$44,751 per reporting cycle__________

ADMINISTRATION OF THE INSTRUMENT:

1. How will you collect the information? (Check all that apply)

[ X ] Web-based

[ ] Email

[ ] Postal Mail

[ ] Other, Explain

Please make sure all instruments, instructions, and scripts are submitted with the request.

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