Foa_Content_of_CDC-RFA-PS-24-00470101SUPP24.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STD AND TB PREVENTION

High-Impact HIV Prevention and Surveillance Programs for Health Departments: Accelerating Pre-Exposure Prophylaxis (PrEP) Uptake for Ending the HIV Epidemic in the United States

CDC-RFA-PS-24-00470101SUPP24

08/31/2024

Table of Contents Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

Part 1. Overview Information

Federal Agency Name:

Federal Centers for Disease Control and Prevention (CDC)

Notice of Funding Opportunity (NOFO) Title:

High-Impact HIV Prevention and Surveillance Programs for Health Departments: Accelerating Pre-Exposure Prophylaxis (PrEP) Uptake for Ending the HIV Epidemic in the United States

Announcement Type:

Revision - Type 3

Agency Notice of Funding Opportunity Number:

CDC-RFA-PS-24-00470101SUPP24

Assistance Listings Number:

93.940

Key Dates:

Due Date for Applications 08/31/2024

08/31/2024 Application must be successfully submitted to Grants.gov by 11:59 pm Eastern Standard Time on the deadline date.

Additional Overview Content:

Executive Summary CDC announces the availability of approximately $7 million in competitive supplemental funding for the 32 health department jurisdictions currently receiving Ending the HIV Epidemic in the US (EHE) initiative funding resources under notice of funding opportunity (NOFO) PS24-0047:

High-Impact HIV Prevention and Surveillance Programs for Health Departments. Fully aligned with PS24-0047, this supplemental NOFO prioritizes acceleration of progress toward achieving the national HIV prevention goal of 50% pre-exposure prophylaxis (PrEP) coverage by the end of 2025. Jurisdictions with greater need for PrEP and lower uptake among priority populations disproportionately affected by HIV and low PrEP prescriptions (i.e., Black and Latino gay, bisexual, and other men who have sex with men (MSM), and Black cisgender and transgender women) need these additional resources and flexibility to accelerate PrEP uptake through patient navigation/case management services and improve patient access to and utilization of existing PrEP services not covered by other financial resources. Recipients will implement enhanced and expanded programs, policies, partnerships and practices to increase access to and uptake of PrEP for priority populations and to help further eliminate structural and social barriers that prevent equitable access to PrEP within EHE jurisdictions. Additionally, these enhanced and expanded PrEP activities will incorporate elements to increase HIV non-occupational post-exposure prophylaxis (PEP) and doxycycline post-exposure prophylaxis (doxy-PEP) awareness and use, including activities with clinicians, non-clinical community-based organizations (CBOs), and persons at risk for HIV acquisition.

This supplemental NOFO's period of performance is September 30, 2024 - May 31, 2025 (8 months). Recipients may request to continue implementation of supplemental activities during PS24-0047 Budget Year 2 (June 1, 2025 - May 31, 2026).

Recipients will implement concurrently all required activities as described in both PS24-0047 and this supplemental NOFO.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STD AND

TB PREVENTION

Healthy People 2030 goal(s)

This NOFO addresses the “Healthy People 2030” focus on HIV, STI, and Health Equity.

Healthy People 2030 has a strong focus on eliminating health disparities and creating equitable opportunities for people to live healthy lives.

https://health.gov/healthypeople/priority-areas

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For purposes of this NOFO, research is defined as set forth in 45 CFR 75.2 and, for further clarity, as set forth in 42 CFR 52.2 (see eCFR :: 45 CFR 75.2 -- Definitions and https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR- 2007-title42-vol1-sec52-2.pdf. In addition, for purposes of research involving human subjects and available exceptions for public health activities, please see 45 CFR 46.102(l) https://www.cdc.gov/hiv/pdf/funding/announcements/ps24-0047/CDC_HIV_PS24-0047-Funding-Tables_020224.pdf https://www.cdc.gov/hiv/funding/announcements/ps24-0047/index.html https://www.cdc.gov/hiv/funding/announcements/ps24-0047/index.html https://health.gov/healthypeople/priority-areas https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf

(https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section- 46.102#p-46.102(l)).

Section I. Funding Opportunity Description

Statutory Authority Statutory Authorities: Section 318(b-c) of the Public Health Service Act (42 USC § 247c(b-c)), as amended.

Background The Centers for Disease Control and Prevention (CDC) recommends pre-exposure prophylaxis (PrEP) as an effective HIV prevention strategy. Taking PrEP medication as prescribed reduces the risk of getting HIV via sexual contact by about 99% and reduces the risk of getting HIV via injection drug use by at least 74%. PrEP has the potential to alter the course of the HIV epidemic in the United States if access and uptake improve substantially among those who can benefit from it use. Since the implementation of the Ending the HIV Epidemic in the US (EHE) initiative in 2019, the number of people in the U.S. who have been prescribed PrEP has increased; however, substantial population-based disparities persist. Efforts to eliminate gender, racial/ethnic, and other disparities in PrEP use must be further strengthened and expanded.

PrEP is financed by private insurance, Medicaid, Medicare, and clinics may also use the 340B Drug Pricing Program. PrEP may also be accessed through pharmaceutical company drug access programs. Though many persons eligible for PrEP have insurance, there remain financial impediments to initiating PrEP for many persons. The US Preventive Services Task Force gave PrEP a grade “A” recommendation. This recommendation requires commercial health plans and Medicaid expansion programs to cover select preventive services – including any service with a Grade A or B from the USPSTF – without cost sharing, which means that these services must be covered before any deductible and without coinsurance or a copayment (https://nastad.org/sites/default/files/2021-12/PDF-PrEP-Coverage-Brief.pdf). Barriers for the un-insured and under-insured persons, such as cost-sharing, must be addressed to improve PrEP uptake and decrease disparities in PrEP access.

The FY 2024 appropriations bill enacted by Congress included funding for the Ending the HIV Epidemic in the U.S. (EHE) Initiative in which it was described that the Committee on Appropriations

‘… supports efforts to increase equitable access to pre-exposure prophylaxis [PrEP] medication that prevents HIV infection. CDC is encouraged to support the building blocks of a national program to increase awareness of PrEP, increase access to PrEP medication, laboratory services, essential support services such as case management, counseling, linkage, and adherence services, robust PrEP outreach and education activities, and PrEP provider capacity expansion. (page 60)’

This NOFO provides the needed additional programmatic resources and flexibility for EHE jurisdictions to accelerate progress toward the national goal of 50% PrEP coverage by 2025, an indicator for the EHE Initiative, and further advance the goals of the National HIV/AIDS Strategy (NHAS), 2022-2025. This NOFO aligns with the Division of HIV Prevention's (DHP’s) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l) https://www.hrsa.gov/opa https://www.hrsa.gov/opa https://nastad.org/sites/default/files/2021-12/PDF-PrEP-Coverage-Brief.pdf https://www.appropriations.senate.gov/imo/media/doc/fy_24_lhhs_report.pdf strategic focus areas to bolster community engagement, health equity, and focus on whole-person approaches to HIV prevention.

Purpose The purpose of this NOFO is to implement enhanced and expanded PrEP programs, policies, partnerships, and practices that 1) increase PrEP access and uptake among populations disproportionately affected by HIV and low PrEP prescriptions (e.g., Black and Latino gay, bisexual, and other men who have sex with men (MSM), and Black cisgender and transgender women), 2) help further eliminate the structural and social barriers that prevent equitable access to PrEP and 3) increase awareness of and access to HIV non-occupational post-exposure prophylaxis (PEP) and doxycycline post-exposure prophylaxis (doxy PEP), including activities with clinicians, non-clinical community-based organizations (CBOs), and persons at risk for HIV acquisition.

PS-24-00470101SUPP24: High-Impact HIV Prevention and Surveillance Programs for Health Departments: Accelerating Pre-Exposure Prophylaxis (PrEP) Uptake for Ending the HIV Epidemic in the United States Logic Model

Strategies and Activities Short-term Outcomes

Intermediate Outcomes

Long-term Outcomes

Prevent – Reduce new HIV transmission by increasing PrEP and PEP services and supporting HIV prevention, including, condom distribution, perinatal transmission prevention and harm reduction services

• Support and promote awareness and access to PrEP and PEP services in counties and states designated as EHE jurisdictions

• Conduct a review of policies and practice of insurance coverage, including cost sharing, for PrEP and PEP medications and related clinical services.

• Implement expanded or enhanced PrEP programs for populations disproportionately affected by HIV and with low rates of PrEP prescriptions

• Supplement patient navigation and case management services

• Improve access to PrEP services by removing barriers and implementing a

• Increased linkage to a PrEP provider among people who can benefit from PrEP

• Increased PrEP prescriptions among people who can benefit from PrEP

• Increased financial coverage for people who can benefit from PrEP

• Increased PEP prescriptions

• Increased financial coverage for people who can benefit from PEP

• At least 50% of persons who can benefit from PrEP receive a PrEP prescription in relevant EHE areas

• Decreased disparities in PrEP prescriptions among priority populations in relevant EHE areas

• Reduced new HIV infection

• Reduced PrEP-related health disparities low-threshold approach to services

• Implement non-occupational PEP awareness and access activities

Recipients are expected to demonstrate measurable progress toward addressing short-term and intermediate performance outcomes that will be monitored during the period of performance. A partial list of short and intermediate outcomes and performance measures are presented below.

Additional data on cost analysis will be collected during the period of performance. CDC will finalize the performance measures, their specific definitions, and data reporting templates in consultation with recipients within 45 days into the supplemental award.

Short-term Outcomes

Increased linkage to a PrEP provider among people who can benefit from PrEP

Measure: Percentage of people testing negative for HIV who can benefit from PrEP* (Numerator: Number of people in the denominator who can benefit from PrEP; Denominator:

Number of people testing negative for HIV)

*Persons who “can benefit from PrEP” include sexually active persons with behavioral indications for PrEP, persons who inject drugs, as well as those who self-requested PrEP.

Persons in the denominator may include those who were tested using PS24-0047 supplement funding, as well as those who did not receive a PS24-0047-funded test but did receive PS24- 0047 supplement funded PrEP services. (PREEXPOSURE PROPHYLAXIS GUIDELINES 2021)

Measure: Percentage of people who were linked to a PrEP provider* (Numerator: Number of people in the denominator who were linked to a PrEP provider; Denominator: Number of people who can benefit from PrEP)

*A person is considered linked to a PrEP provider after they attend their first appointment. A PrEP provider is a health care professional (e.g., physician, advanced practice nurse, physician assistant) who conducts evaluations for PrEP eligibility and clinical appropriateness, prescribes PrEP, and provides comprehensive management of persons taking PrEP.

Increased PrEP prescriptions among people who can benefit from PrEP

Measure: Percentage of people who received PrEP prescriptions (Numerator: Number of people in the denominator who were prescribed PrEP; Denominator: Number of people who can benefit from PrEP)

Increased financial coverage for people who can benefit from PrEP

Measure: Number of people and actual cost for purchasing PrEP medications

Measure: Number of people and actual cost for co-paying for laboratory testing

Measure: Number of people and actual cost for co-payments for clinical services (i.e., evaluation and management; and STI screening and treatment)

Increased PEP prescriptions

Measure: Number of people who received PEP prescriptions

Increased financial coverage for people who can benefit from PEP

Measure: Number of people and actual cost for purchasing PEP medications

Measure: Number of people and actual cost of payments for laboratory testing https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf

Measure: Number of people and actual cost of payments for clinical services (i.e., evaluation and management; and STI screening and treatment)

Intermediate Outcomes (as measured and reported in CDC HIV Surveillance Report)

At least 50% of persons who can benefit from PrEP receive a PrEP prescription in relevant EHE areas

Decreased disparities in PrEP prescriptions among priority populations in relevant EHE areas

Note: Stratification by client characteristics include age, gender (cisgender and transgender men and women, persons of other gender identities), transmission (sexual contact [same sex and opposite sex] and injection drug use), and racial and ethnic populations (Black and Hispanic persons).

CDC Evaluation and Performance Measurement Strategy

CDC will use a three-pronged approach to monitoring, evaluation, accountability, and quality assurance for this supplemental NOFO: 1) recipient performance monitoring; 2) local evaluation;

and 3) CDC’s evaluation of the collective impact of the supplemental NOFO across all recipients. This approach will use data to (a) monitor and evaluate the supplemental NOFO overall, (b) determine if strategies and activities are being implemented as expected, (c) assess whether intended short-term and intermediate outcomes are being achieved, and (d) drive continuous program improvement.

Recipient performance monitoring will ensure quality and accountability by using data to track implementation of recipient strategies and activities (process monitoring) and to determine progress toward achieving the outcomes (outcome monitoring).

Local (recipient) evaluation and performance measurement will involve use of data by recipients at the local level to monitor, evaluate, and continuously improve program performance.

CDC’s evaluation of the collective impact will use multiple methods, such as collection and analysis of quantitative and qualitative data on program implementation and performance, submitted by recipients, and tracking of key standardized performance measures. During the project period, CDC may partner with recipients on evaluation activities.

To facilitate the supplemental funding reporting structure and requirements, recipients will collect the required quantitative and qualitative data using CDC approved applications (software) and submit data to CDC every 4 months via CDC approved data collection templates. Data collection for the HIV program has been approved by the Office of Management and Budget (OMB) Number 0920-0696, National HIV Prevention Program Monitoring and Evaluation, Expiration Date: October 31, 2024. Changes to data collection requirements during the project period will be subject to review and approval by OMB.

Findings will be systematically reviewed by CDC to identify challenges encountered by recipients, identify capacity-building assistance needs and actions needed to improve overall project performance, compare methods and outcomes across recipients to identify promising practices for dissemination during the period of performance, demonstrate the value of the supplemental NOFO (e.g., improved PrEP outcomes), and contribute to the evidence base for strategies and activities. CDC may also use the data to inform other Federal and external partners; CDC may inform the recipient of the intent of informing partners and give appropriate attribution to the recipient’s involvement.

Program Implementation

Recipient Activities

CDC’s NOFO PS24-0047: High-Impact HIV Prevention and Surveillance Programs for Health Departments funds HIV prevention including:

‘Strategy 3: Prevent HIV transmission by increasing PrEP coverage to 50% of estimated people with indications for PrEP, increasing PEP services, and supporting HIV prevention, including condom distribution, prevention of perinatal transmission, harm reduction, and syringe services program (SSP) efforts.

Activity 3a: Support and promote awareness and access to PrEP and PEP services.’ (p.21)

In alignment with PS24-0047 and collectively addressing the strategies of this NOFO as specified in the logic model above, recipients are required to implement the following expanded and/or enhanced PrEP and PEP activities:

1. Workforce and Leadership, identify (or hire) an HIV Prevention PrEP Coordinator (herein, PrEP Coordinator) at a minimum 50% effort level to coordinate all supplemental funding efforts, AND an epidemiologist/data manager at a minimum 50% effort level to ensure data collection and reporting are complete across all supplemental funded activities. The PrEP Coordinator should report to (or work alongside) the jurisdiction’s

EHE Coordinator and work within the structure of the EHE advisory group established under Strategy 6 (PS24-0047, pages 29-31).

1. CDC encourages recipients to staff these roles from populations with:

1. Lived experience as a person with an indication for PrEP.

2. Members of the focal population(s) or persons with extensive professional experience working with focal population(s).

2. Create an ‘HIV Prevention PrEP and PEP Action Plan’ to guide the implementation of a coordinated and comprehensive approach to maximizing the uptake of PrEP and PEP. If the jurisdiction already has a similar document in place, then that document can be expanded upon. It should be inserted into the current Jurisdiction’s Ending the HIV Epidemic Plan or the Integrated HIV Prevention and Care Plan (Jurisdictional Plan) as an addendum (PS24-0047, page 30).

1. The PrEP Coordinator should review and use the jurisdictional EHE plan and Integrated HIV Plan for all PrEP and PEP related activities and goals with a specific focus to achieve at least 50% PrEP coverage.

2. The PrEP Coordinator should identify and detail in the ‘HIV Prevention PrEP and PEP Action Plan’ all PrEP and PEP related services and resources including efforts supported with federal, state, tribal, local, and private sector funds (see appendix for suggested sources).

3. The PrEP Coordinator should lead a review of policies and programmatic application of insurance coverage for PrEP and PEP medications and related clinical services in the jurisdiction. The policy and program review should identify issues related to cost-sharing expenses that can be addressed with public and private insurers and with the state Health Insurance Commissioner.

4. The PrEP Coordinator should host a PrEP Summit with jurisdictional partners within 3 months of the Notice of Award to present the ‘HIV Prevention PrEP and PEP Action Plan’.

5. The PrEP Coordinator should lead efforts to develop and sustain a collaborative network of all PrEP and PEP related activities for regular communication via email, virtual or in-person meetings, and a website (or similar method for communication) for sharing information. This could be accomplished through the EHE advisory group.

6. The PrEP Coordinator and epidemiologist/data manager shall report quantitative and qualitative progress every 4 months to CDC using a secure data reporting database and template provided by CDC (see evaluation and performance measurement section).

7. The PrEP Coordinator shall review and update (if necessary) the ‘HIV Prevention PrEP and PEP Action Plan’ in conjunction with the progress report.

3. At least 50% of the amount of funds from this supplement must be used for one or more of the following:

1. The following core medical services should comprise at least 50% of the allowable costs to meet this supplemental funding requirement:

1. Cost of PrEP/PEP medications or co-pays for PrEP/PEP medications

2. Cost of PrEP/PEP-related laboratory testing

3. Cost of PrEP/PEP-related office visits and preventive counseling visits

4. Expand sexual health services to provide PrEP/PEP and to incorporate STI screening and treatment for STIs as required in the PrEP Guidelines (PREEXPOSURE PROPHYLAXIS GUIDELINES 2021) and use of doxycycline post-exposure prophylaxis (doxy PEP) for bacterial STI prevention (CDC Clinical Guidelines on the Use of Doxycycline Postexposure Prophylaxis for Bacterial Sexually Transmitted Infection Prevention, United States, 2024 | MMWR).

5. Establish or expand a PrEP Navigator/Case Management Program designed to address the needs of populations with who can benefit from PrEP/PEP that are currently underserved by PrEP programs (e.g., Black cisgender and transgender women, Black and Latino gay, bisexual, and other men who have sex with men/same gender loving, etc.). The PrEP Navigator/Case Management Program should provide direct assistance to clients to access health insurance as well as private or public PrEP co-pay assistance programs for uninsured and underinsured persons. The program should also provide staff and other support for referrals to other services including primary care, mental health, substance use, food security, transportation, and housing assistance.

Note: Once a client is eligible to receive services funded by this supplemental award, the PrEP/PEP program is considered the payor of last resort, and as such, funds may not be used for any item or service to the extent that payment has been made, or can reasonably be expected to be made under any State compensation program, under an insurance policy, or under any Federal or State health benefits program, or by an entity that provides health services on a pre-paid basis.

Additionally, the CDC recommends recipient jurisdictions work with their state Health Insurance Commissioner’s Office to resolve out-of-pocket expenses among those with health insurance coverage. The Affordable Care Act (ACA) requires commercial health plans and Medicaid expansion programs to cover PrEP without cost sharing since the US Preventive Services Task Force gave PrEP a grade “A” recommendation. (NASTAD's PrEP Coverage Brief). The CDC also suggests taking advantage of 340B pricing (HRSA 340B Drug Pricing Program) when the funding recipient selects to pay for the medication, and to maximally utilize pharmaceutical company drug access programs.

4. Can include or expand any of the activities related to PrEP and PEP under PS24-0047 ‘Additional Activities for Implementation’ (pages 23 and 24).

In addition, the following optional activity is allowed:

• Establish, expand, or contract with an online, remote, telehealth option(s) for secure, HIPAA compliant access to PrEP/PEP services, with a focus on populations who can most benefit from PrEP/PEP, populations with least current uptake and/or areas with a lack of PrEP/PEP providers in the jurisdiction. This activity should also include awareness and demand generation strategies to drive uptake in this intervention.

o Resources for implementing this activity include but are not limited to:

▪ Prime Health’s TelePrEP Implementation Toolkit

▪ NASTAD’s TelePrEP Online Learning Series https://www.cdc.gov/mmwr/volumes/73/rr/rr7302a1.htm https://www.cdc.gov/mmwr/volumes/73/rr/rr7302a1.htm https://www.cdc.gov/mmwr/volumes/73/rr/rr7302a1.htm https://nastad.org/sites/default/files/2021-12/PDF-PrEP-Coverage-Brief.pdf https://www.hrsa.gov/opa https://www.primehealthco.com/teleprep https://telepreponlinelearningseries.thinkific.com/

CDC Activities In a cooperative agreement, CDC staff are substantially involved in the program activities, above and beyond routine grant monitoring. CDC activities for this program are as follows:

1. Collaborate to ensure coordination and implementation of strategies to support the implementation of HIV surveillance and prevention activities.

2. Work with recipients to identify and address capacity building assistance (CBA) and TA needs that are essential to the success of the project. Recipients must work with the assigned Project Officer to establish a mechanism to request direct CDC TA via the designated CDC system or portal.

3. Provide access to training and TA that will strengthen staff capacity relevant to all required strategies and activities of the program.

4. Provide guidance to recipients and set standards on data collection, use, and submission requirements.

5. Facilitate coordination, collaboration, and, where feasible, service integration among federal agencies, other CDC funded programs, other health departments, community based organizations, local and state planning groups, other CDC directly funded programs, national capacity building assistance providers, medical care providers, laboratories, recipients of the Ryan White HIV/AIDS Treatment Extension Act of 2009, and other partners working with people with HIV and at greatest risk for HIV infection toward common goals of risk reduction, disease detection, and a continuum of HIV prevention, care, and treatment.

6. Monitor recipient program performance using multiple approaches, such as site visits, emails, conference calls, and standardized review of performance, recipient feedback and other data reports, to support program development, implementation, evaluation, and improvement.

7. Provide guidance and coordination to funded organizations to improve the quality and effectiveness of work plans, evaluation strategies, products and services, and collaborative activities with other organizations.

8. Collaborate to compile and publish accomplishments, best practices, performance criteria, and lessons learned during the project period.

9. Collaborate in assessing progress toward meeting strategic and operational goals/objectives and in establishing measurement and accountability systems outcomes, such as increased performance improvements and best or promising practices.

10. Collaborate on strategies to ensure the provision of appropriate and effective HIV prevention services to populations of focus.

11. Provide requirements and expectations for standardized and other data reporting and support monitoring and evaluation activities.

12. Share information, best practices, lessons learned, and evaluation results (e.g., through conferences, guidance, material development, webinars, data sharing publications, other social media, participation in meetings, committees, conference calls, and working groups related to the cooperative agreement and its projects).

13. Validation-Completion of a comprehensive Assessment of Data Security and Confidentiality Protections at least once during the project period. See Appendix B of the guidance (pages 43-54) for a more detailed description of the process and content. Upon completion and submission, the assessment will be reviewed and validated by CDC program monitors.

Funding Strategy Funding strategy will be based on 3-phase review and selection process as described in the supplemental NOFO.

Section II. Award Information

Type of Award:

CA (Cooperative Agreement) CDC substantial involvement in this program appears in the Activities Section above.

Award Mechanism:

U62 HIV Prevention Activities Health Department Based

Fiscal Year Funds:

Approximate Total Supplemental Funding:

$7,000,000 This amount is subject to availability of funds. Includes direct and indirect costs.

Approximate Number of Awards:

Up to 4 awards

Approximate Average Award:

$1,750,000 This amount is for the budget period only and includes direct costs and indirect costs as applicable.

Floor of Individual Award Range:

$0 Ceiling of Individual Award Range:

$0 This ceiling is for a 12-month budget period.

Anticipated Award Date:

September 30, 2024

Budget Period Length:

8 month(s)

Period of Performance Length:

0 year(s)

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

Eligible Applicants The following recipients may submit an application:

Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

Additional Information on Eligibility Due to statutory authority, this supplemental funding opportunity is offered to the 32 state, local and territorial health departments currently receiving Ending the HIV Epidemic in the U.S.

(EHE) funding under notice of funding opportunity (NOFO) PS24-0047: High-Impact HIV Prevention and Surveillance Programs for Health Departments.

Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission (SF-424, field 8c). The UEI is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov- Finding the UEI.

a. Unique Entity Identifier (UEI):

All applicant organizations must obtain a Unique Entity Identifier (UEI) number by registering in SAM.gov prior to submitting an application. A UEI number is a unique twelve-digit identification number assigned to the registering organization.

If funds are awarded to an applicant organization that includes sub-recipients, those sub-recipients must provide their UEI numbers before accepting any funds.

b. System for Award Management (SAM):

https://www.cdc.gov/hiv/pdf/funding/announcements/ps24-0047/CDC_HIV_PS24-0047-Funding-Tables_020224.pdf https://www.cdc.gov/hiv/pdf/funding/announcements/ps24-0047/CDC_HIV_PS24-0047-Funding-Tables_020224.pdf https://www.grants.gov/ https://www.gsa.gov/about-us/organization/federal-acquisition-service/technology-transformation-services/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-id-is-here https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/

The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as a recipient. All applicant organizations must register with SAM, and will be assigned a SAM number and a Unique Entity Identifier (UEI). All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC.

If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. NOFO applicants are to initiate their SAM registrations as soon as possible. Additional information about registration procedures may be found at https://www.cdc.gov/grants/applying/sam.html, SAM.gov and the SAM.gov Knowledge Base.

c. Grants.gov:

The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the "Applicant Registration" option at www.grants.gov.

All applicant organizations must register at www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants should start the registration process as early as possible.

Cost Sharing or Matching

Cost Sharing / Matching Requirement:

No

Other

Special Requirements Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award.

Maintenance of Effort Maintenance of Effort is not required for this program.

Section IV. Application and Submission Information

Address to Request Application Package Applicants may access the application at www.grants.gov. Additional information about applying for CDC grants and cooperative agreements can be found here:

https://www.cdc.gov/grants/applying/pre-award.html.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it is needed. You can https://www.cdc.gov/grants/applying/sam.html https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0 https://www.grants.gov/ http://www.grants.gov/ https://www.grants.gov/ https://www.cdc.gov/grants/applying/pre-award.html reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov.

Submissions sent by email, fax, CD’s or thumb drives of applications will not be accepted.

Content and Form of Application Submission Unless specifically indicated, this announcement requires submission of the following information:

Table of Contents

Project Abstract A Project Abstract must be completed in the Grants.gov application forms. The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader.

This abstract must not include any proprietary/confidential information.

Project Narrative A Project Narrative must be submitted with the application forms. The project narrative can be uploaded using PDF, Word, or Excel file formats when submitting via Grants.gov. The narrative must be submitted in the following format:

• 20: Maximum number of pages

• Font size: 12 point unreduced, Times New Roman

• Single spaced

• Page margin size: One inch

• Number of all narrative pages; not to exceed the maximum number of pages.

The narrative should address activities to be conducted over the entire Period of Performance and must include the following items in the order listed.

• Background

• Approach o Purpose o Outcomes o Strategies and Activities

• Evaluation and Performance Measurement Plan

• Organizational Capacity

• Work Plan

Additional information may be included in the application appendices. The appendices must be uploaded to the "Other Attachments Form" of application package in Grants.gov. Note:

appendices will not be counted toward the narrative page limit. This additional information includes:

mailto:support@grants.gov

Additional information submitted via Grants.gov can be uploaded in PDF, Word, or Excel file formats, and should be named:

_________: Maximum number of allowable electronic attachments

Submission Dates and Times This announcement is the definitive guide on application content, submission, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline published herein, it will not be eligible for review and the recipient will be notified the application did not meet the submission requirements.

This section provides applicants with submission dates and times. Applications that are submitted after the deadlines will not be processed.

If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which Grants.gov operations resume.

Application Deadline Date

Due Date for Applications 08/31/2024

08/31/2024 Explanation of Deadlines: Application must be successfully submitted to Grants.gov by 11:59 pm Eastern Time on the deadline date.

Topic: Informational Call

Day/Time: Tuesday, August 6, 2024, 1:00 pm - 2:00pm ET

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Employee Whistleblower Rights and Protections

All recipients of an award under this NOFO will be subject to a term and condition that applies the requirements set out in 41 U.S.C. § 4712, “Enhancement of contractor protection from reprisal for disclosure of certain information” and 48 Code of Federal Regulations (CFR) section

3.9 to the award, which includes a requirement that recipients and subrecipients inform https://aka.ms/JoinTeamsMeeting?omkt=en-US https://teams.microsoft.com/l/meetup-join/19%3ameeting_MGQ0ZjM1OTgtZjYzYS00NTUwLWIzNTYtYThjMmNmYTIwNDcz%40thread.v2/0?context=%7b%22Tid%22%3a%229ce70869-60db-44fd-abe8-d2767077fc8f%22%2c%22Oid%22%3a%220337a4b3-41a7-4b2d-a028-393b1af1439c%22%7d tel:+14047183800,,8662485 tel:8889944478,,8662485 https://dialin.teams.microsoft.com/f157e5c8-9e01-4021-b245-b3aec6e9a1bc?id=8662485 employees in writing (in the predominant native language of the workforce) of employee whistleblower rights and protections under 41 U.S.C. § 4712. For more information see:

https://oig.hhs.gov/fraud/whistleblower/.

Copyright Interest Provisions This provision is intended to ensure that the public has access to the results and accomplishments of public health activities funded by CDC. Pursuant to applicable grant regulations and CDC’s Public Access Policy, Recipient agrees to submit into the National Institutes of Health (NIH) Manuscript Submission (NIHMS) system an electronic version of the final, peer-reviewed manuscript of any such work developed under this award upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. Also at the time of submission, Recipient and/or the Recipient’s submitting author must specify the date the final manuscript will be publicly accessible through PubMed Central (PMC). Recipient and/or Recipient’s submitting author must also post the manuscript through PMC within twelve (12) months of the publisher's official date of final publication; however the author is strongly encouraged to make the subject manuscript available as soon as possible. The recipient must obtain prior approval from the CDC for any exception to this provision.

The author's final, peer-reviewed manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Recipient and its submitting authors working under this award are responsible for ensuring that any publishing or copyright agreements concerning submitted articles reserve adequate right to fully comply with this provision and the license reserved by CDC. The manuscript will be hosted in both PMC and the CDC Stacks institutional repository system. In progress reports for this award, recipient must identify publications subject to the CDC Public Access Policy by using the applicable NIHMS identification number for up to three (3) months after the publication date and the PubMed Central identification number (PMCID) thereafter.

Funding Restrictions Funding Restrictions:

Restrictions, which must be taken into account while writing the budget, are as follows:

• Recipients may not use funds for research.

• Recipients may not use funds for clinical care.

• Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

• Recipients may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment. Any such proposed spending must be identified in the budget.

• The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

Other than for normal and recognized executive-legislative relationships, no funds may be used for: publicity or propaganda purposes, for the preparation, distribution, or use of any material https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Foig.hhs.gov%2Ffraud%2Fwhistleblower%2F&data=05%7C01%7CJohanna.Nestor%40hhs.gov%7Cf34ed74742564378251308da2473efc4%7Cd58addea50534a808499ba4d944910df%7C0%7C0%7C637862377604470835%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=bVVQ8tvYrX60jPRzmve0z6yqvvCtl9ml6mEr%2BGLf6SY%3D&reserved=0 designed to support or defeat the enactment of legislation before any legislative body the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before any legislative body.

See Additional Requirement (AR) 12 for detailed guidance on this prohibition and additional guidance on anti-lobbying restrictions for CDC recipients.

• Recipients may not use funds to purchase antiretroviral therapy for treatment of persons with HIV.

• Federal funds used for the purchase of supplies or equipment related to injection drug use must comply with current federal law.

• Funding should not be used for construction purposes.

The recipient can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address:

http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html

Other Submission Requirements Application Submission Submit the application electronically by using the forms and instructions posted for this funding opportunity on www.Grants.gov.

Note: Application submission is not concluded until successful completion of the validation process. After submission of your application package, recipients will receive a "submission receipt" email generated by Grants.gov. Grants.gov will then generate a second e-mail message to recipients which will either validate or reject their submitted application package.

This validation process may take as long as two (2) business days. Recipients are strongly encouraged check the status of their application to ensure submission of their application package is complete and no submission errors exists. To guarantee that you comply with the application deadline published in the Notice of Funding Opportunity, recipients are also strongly encouraged to allocate additional days prior to the published deadline to file their application. Non-validated applications will not be accepted after the published application deadline date.

In the event that you do not receive a ''validation'' email within two (2) business days of application submission, please contact Grants.gov. For instructions on how to track your application, refer to the e-mail message generated at the time of application submission or review the Applicants section on www.grants.gov.

Electronic Submission of Application:

Applications must be submitted electronically by using the forms and instructions posted for this notice of funding opportunity at www.grants.gov. Applicants can complete the application package using Workspace, which allows forms to be filled out online or offline. All application https://www.cdc.gov/grants/additional-requirements/ar-12.html http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html http://www.grants.gov attachments must be submitted using a PDF file format. Instructions and training for using Workspace can be found at www.grants.gov under the "Workspace Overview" option.

Applications submitted through www.Grants.gov, are electronically time/date stamped and assigned a tracking number. The Authorized Organizational Representative (AOR) will receive an e-mail notice of receipt when HHS/CDC receives the application. The tracking number serves to document submission and initiate the electronic validation process before the application is made available to CDC for processing.

If the recipient encounters technical difficulties with Grants.gov, the recipient should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week. The Contact Center provides customer service to the recipient community. The extended hours will provide recipients support around the clock, ensuring the best possible customer service is received any time it’s needed. You can reach the Grants.gov Support Center at 1-800- 518-4726 or by email at support@grants.gov. Submissions sent by e-mail, fax, CD’s or thumb drives of applications will not be accepted.

After consulting with the Grants.gov Support Center, if the technical difficulties remain unresolved and electronic submission is not possible to meet the established deadline, organizations may submit a request prior to the application deadline by email to the Grants Management Specialist/Officer for permission to submit a paper application. An organization's request for permission must: (a) include the Grants.gov case number assigned to the inquiry, (b) describe the difficulties that prevent electronic submission and the efforts taken with the Grants.gov Support Center (c) be submitted to the Grants Management Specialist/Officer at least 3 calendar days prior to the application deadline. Paper applications submitted without prior approval will not be considered.

Section V. Application Review Information Eligible recipients are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the CDC-RFA-PS-24-00470101SUPP24 Measures of effectiveness must relate to the performance goals stated in the "Purpose" section of this announcement. Measures of effectiveness must be objective, quantitative and measure the intended outcome of the proposed program. The measures of effectiveness must be included in the application and will be an element of the evaluation of the submitted application.

Criteria Eligible recipients will be evaluated against the following criteria:

Approach Maximum Points: 40

Evaluate the extent to which the applicant:

1. Describes a comprehensive understanding of the purpose and intended outcomes of the supplemental NOFO (5 points)

2. Describes an overall strategy consistent with the Project Description and logic model, including describing how the applicant will promote health equity, whole person mailto:support@grants.gov approaches to HIV prevention, syndemic approaches, and community engagement within their supplemental program model (10 points)

3. Describes an overarching approach to execute all required strategies and activities efficiently and effectively as described in the supplemental NOFO. (10 points)

4. Describes existing initiatives in the jurisdiction upon which supplemental NOFO activities will build. Describe how supplemental activities will differ from related work currently funded under PS24-0047 and how the work would be innovative and successful. (5 points)

5. Presents a detailed work plan that aligns outcomes and activities with proposed SMART objectives, action steps, and performance measurement as described in the supplemental NOFO (10 points)

Evaluation and Performance Measurement Maximum Points: 30

Evaluate the extent to which the applicant:

1. Describes how supplemental NOFO activities will be integrated into your PS24-0047 EPMP including the Data Management Plan. (5 points)

2. Describes the…