RFA-PS-22-004.pdf

Centers for Disease Control and Prevention

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

Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a

Transformational Era

RFA-PS-22-004

Application Due Date will be submitted as: date based on the value specified for Due Date for Applications

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

Overview Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Notice of Funding Opportunity (NOFO) Title Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era Activity Code U01 - Research Project - Cooperative Agreement

Notice of Funding Opportunity Type Reissue of Agency Notice of Funding Opportunity Number

RFA-PS-22-004

Assistance Listings Number(s) 93.084 Category of Funding Activity HL - Health NOFO Purpose This NOFO supports research on HIV/STD risk and prevention behavior in an era when new pre-exposure prophylaxis (PrEP) methods are becoming available for a diverse community-based sample of gay, bisexual, and other men who have sex with men (MSM). The aim is to study PrEP use and other HIV/STD prevention behaviors over time among MSM in three (3) regions of the US, one of which should include the US South, given that states in the US South have higher rates of HIV incidence and prevalence compared to other national regions. The study should also serve to develop and test (quantitatively and qualitatively) brief PrEP and other HIV/STD prevention messaging to enhance protective behaviors among MSM. All MSM should receive alternating quarterly HIV and STD tests (i.e., an HIV test in one quarter, an STD test in the next quarter) and referral to prevention and treatment care, as requested or needed. Rapid reports should be provided following each wave of data collection to identify community trends and implications for prevention messaging. It is anticipated that this NOFO will support one multisite cooperative agreement award that covers three (3) research sites. The research sites should be priority jurisdictions outlined in Ending the HIV Epidemic in the United States (EHE), in support of the goals of EHE and the National Strategic Plan, and other federal prevention planning efforts.

Key Dates Publication Date:

To receive notification of any changes to RFA-PS-22-004, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

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Letter of Intent Due Date:

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

12/17/2021

Application Due Date:

Application Due Date will be submitted as: date based on the value specified for Due Date for Applications 01/18/2022

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

E-mail: commons@od.nih.gov Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review:

03/17/2022 Secondary Review:

04/19/2022 Estimated Start Date:

08/01/2022 Expiration Date:

01/19/2022 Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note:The Research Strategy component of the Research Plan is limited to 15 pages.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Applications that do not comply with these instructions may be delayed or may not be accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose: This NOFO supports research on HIV/STD risk and prevention behavior in an era when new PrEP methods are becoming available for a diverse community-based sample of gay, bisexual, and other men who have sex with men (MSM). The study should also serve to develop and test (quantitatively and qualitatively) brief prevention messaging to enhance protective behaviors among MSM. All MSM should receive alternating quarterly HIV and STD tests (i.e., an HIV test in one quarter, an STD test in the next quarter) and referral to prevention and treatment care as requested or needed.

Rapid reports should be provided following each wave of data collection to identify community trends and implications for prevention messaging. The aim of this research is to study HIV prevention behavior among MSM in three (3) regions of the US, one of which should include the US South, given that states in the US South have higher rates of HIV incidence and prevalence compared to other national regions. The research sites should be priority jurisdictions outlined in Ending the HIV Epidemic in the United States (EHE), in support of the goals of EHE and the National Strategic Plan, and other federal prevention planning efforts.

Mechanism of Support: U01 – Research Project - Cooperative Agreement Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire four (4)-year project period is $5,900,000. The number of cooperative agreement awards is anticipated to be one (1) that includes three (3) research sites. Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) is $1,475,000. The estimated total funding (direct and indirect) for the entire project period is $5,900,000. The project period is anticipated to run from 08/01/2022 through 07/31/2026.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III of this announcement are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. There will only be one PD/PI for each application.

Number of Applications. Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

Application Type. New.

Application Materials. See Section IV.1 for application materials. Please note that

SF424 (R&R) Form F is to be used when completing the application package. Please see https://grants.nih.gov/grants/how-to-apply-application-guide.html

Section I. Funding Opportunity Description Statutory Authority Public Health Service Act, Section 317(k)(2) [42 USC 247b(k)(2)], Section 318 [42 USC 247(c)], and Section 301(a) [42 U.S.C. 241(a)], as amended.

1. Background and Purpose Gay, bisexual, and other MSM continue to be over-represented among incident and prevalent HIV infections in the United States, especially Black/African American and Hispanic/Latino MSM. Further, states in the US South have higher rates of HIV incidence and prevalence compared to other national regions. Effective daily oral PrEP is now a standard HIV prevention option in an era of emerging HIV prevention technologies (e.g., injectable, and event-based oral PrEP). With the availability of new prevention methods in coming years, the prevention field needs to prepare for, adapt, and make available timely and relevant messages and brief interventions that meet the changing needs of MSM and their communities around HIV prevention. As with condom use (the sole previous biomedical product available for HIV primary prevention) earlier in the HIV epidemic, emerging PrEP-related behavioral issues and patterns need to be identified, monitored over time, and addressed through public health messaging. For example, a recent study found 11% of MSM shared their PrEP pills with others, a concerning development for safety and monitoring of medication use, whereas other researchers found cases of HIV-negative MSM monitoring the viral loads of their HIV-positive partners to reduce HIV transmission risk. Other research on daily oral PrEP highlights issues related to lack of PrEP awareness, poor uptake, cost and other barriers to access (especially in minority communities), medical mistrust, adherence concerns, stigma, number of sexual partners and concerns over side effects.

In the coming years, long-acting injectable and event-based PrEP regimens will be available as additional prevention methods, besides daily oral PrEP, and condoms. Recent research has demonstrated efficacy for the event-based regimen (i.e., sexual event-driven PrEP consisting of two pills within 24 hours before sex, and one pill daily for two days after sex) with nearly a quarter of PrEP users at high-risk of HIV preferring on-demand PrEP. Reyniers et al. found that common benefits mentioned for event-based dosing include fewer pills and reduced costs and side effects. Being able to tailor the need for PrEP according to one’s lifestyle allows the user to anticipate the risk of HIV transmission. In one online sample of MSM, nearly two-thirds were interested in non-daily or event-based use of PrEP. Similarly, recent studies examining the efficacy of long-acting injectable PrEP, have been promising among cisgender women, MSM, and transgender women who have sex with men. In a sample of 948 MSM, 46% expressed a preference for the injectable form of PrEP as compared to 14.3% who preferred the daily oral pill. Furthermore, in a national survey of 4,638 participants, over 73% expressed interest in injectable PrEP. Findings indicated that participants who were interested in the injectable form of PrEP were more likely to be 26-39 years old, African American or Hispanic/Latino, report more condomless anal sex, have completed high school education or less, and have experienced oral PrEP. Potential benefits of injectable medication include reduced medication adherence and reduced potential for gastrointestinal toxicity. In one trial of rectal microbicides, adherence to daily rectal gel was not as high compared to use before and after receptive anal intercourse. Some individuals may prefer microbicides due to potential intermittent dosing, lubrication factor for sex, and fewer side effects. On-demand or event-driven PrEP (also known as the PrEP 2-1-1 protocol) is currently not approved by the FDA but is endorsed by the International AIDS Society USA. Long-acting injectable PrEP products are currently being tested in clinical trials and have not been approved by the FDA.

In this transformational era of HIV prevention products, public health researchers and practitioners need to understand the use of multiple primary prevention methods by MSM over time. This includes awareness, uptake, adherence, persistence, and maintenance of new methods, appropriate combinations of prevention methods (such as PrEP and condom use), and conditions that impact transitions among prevention products over time. Prevention messaging will continue to evolve as new prevention methods are promoted and MSM have increasingly more complex choices to make.

The purpose of this cooperative agreement funding opportunity is multifold (See Figure 1):

1. Enroll at least n=1275 HIV-negative MSM across three (3) sites (n=425 per site) with a portion currently on PrEP (total n=750 currently on PrEP; n=250 per site) and a smaller portion not currently on PrEP (total n=525 not currently on PrEP; n=175 per site) over two (2) years.

Quantitative assessments should be conducted quarterly (total eight (8) assessment waves) that address:

PrEP use, PrEP adherence, condom use, HIV/STD sexual risk-taking behavior, and substance using behavior

Awareness, knowledge, beliefs, and perceptions of various HIV/STD prevention products

Development and testing of prevention messages Maintaining a minimum 80% retention throughout the study

2. The sample should include a minimum of n=380 (~30%) Black/African American and n=380 (~30%) Hispanic/Latino MSM. All study materials and assessments should be offered in both English and Spanish language, with bilingual staff support. Quarterly HIV or STD testing of participants, alternating so that HIV and STD testing are completed every six (6) months, should be provided as a study benefit to participants as well as for study monitoring, including:

Linkage to care for newly HIV and STD diagnosed men identified through testing during the two (2) -year assessment period, with follow up to facilitate and ensure care.

3. Completion of at least three (3) qualitative assessments (in-depth interviews and focus groups) with a subsample of men. Assessments should be staggered approximately every six (6) months during the study period (n=90 total; n=30 each assessment) to address issues regarding:

PrEP use, PrEP adherence, condom use, and HIV sexual risk behaviors and substance using behavior

Awareness, knowledge, beliefs, and perceptions of various HIV prevention products Testing of brief HIV prevention messages for prevention products

4. Rapid reports following each quantitative assessment wave, and associated HIV/STD test results, or each qualitative study that summarizes key findings and trends, and implications for prevention messaging. The reports will describe PrEP and condom use behavior and patterns over time, with a focus on gaps in protection and opportunities for enhanced prevention messaging to reduce risk for HIV/STD infection. Specific recommendations should be provided for prevention messages based on messaging development research conducted within the study.

Figure 1. Study Assessment and Report Timeline

Quantitative Assessment X X X X X X X X HIV Testing X X X X STD Testing X X X X Qualitative Assessment X X X Rapid Reporting (following*) X X X X X X X X

1 2 3 4 5 6 7 8 Quarterly Assessment Wave*

This four (4)-year funding opportunity is anticipated to award one cooperative agreement recipient to develop and implement the protocol and assessments -- including large-scale MSM recruitment, enrollment, retention, and rapid reports for the results and implications after each assessment point -- in three (3) cities, each representing a distinct region of the US (including one in the US South) for broad geographical representation (see https://www.cdc.gov/hiv/pdf/statistics/overview/cdc-hiv-geographic-distribution.pdf] and be consistent with the identified EHE jurisdictions [see https://www.cdc.gov/endhiv/jurisdictions.html].

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Health Equity:

CDC supports efforts to improve the health of populations disproportionately affected by infectious diseases by maximizing the health impact of public health services, reducing disease incidence, and advancing health equity.

A health disparity occurs when a health outcome is seen to a greater or lesser extent between populations. Health disparities in infectious diseases are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these infections and diseases.

Social determinants are conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of life-risks and outcomes (https://www.cdc.gov/socialdeterminants/index.htm). These include conditions for early childhood development; education, employment, and work; food security, health services, housing, income, and social exclusion. Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic challenges. It requires:

Continuous efforts focused on elimination of health disparities, including disparities in health and in the living and working conditions that influence health, and

Continuous efforts to maintain a desired state of equity after health disparities are eliminated.

Applicants should use data, including social determinants data, to identify communities within their jurisdictions that are disproportionately affected by infectious diseases and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, applicants should consider social determinants of health in the development, implementation, and evaluation of specific efforts and use culturally appropriate interventions and strategies that are tailored for the communities for which they are intended.

Healthy People 2030 and other National Strategic Priorities This announcement aims to accelerate evidence-informed decision making and performance improvements to HIV prevention strategies. Several Healthy People 2030 (HP 2030) objectives are supported through this NOFO. The HP 2030 objectives supported by this announcement include:

Reduce new HIV infections

• HIV-1 Reduce the number of new HIV diagnoses

• HIV-2 Reduce the number of new HIV infections among adolescents and adults

Increase HIV testing and prevent HIV risk

• HIV-13 Increase the proportion of persons living with HIV who know their serostatus

• HIV-17 Increase the proportion of sexually active persons who use condoms

Increase access to care and improve health outcomes for people living with HIV

• HIV-19 Increase the percentage of persons with newly diagnosed HIV infection linked to HIV medical care (had a routine HIV medical visit) within one month of their HIV diagnosis

Public Health Impact This NOFO aligns with the Ending the HIV Epidemic (EHE) Initiative and CDC Division of HIV Prevention (DHP) Strategic Plan to: (1) reduce the number of new HIV infections; (2) increase access to care and optimize health outcomes for people with HIV; and (3) reduce HIV-related disparities.

Ending the HIV Epidemic: A Plan for America - https://www.hiv.gov/ending-hiv-epidemic

Secretary’s Minority HIV/AIDS Fund (MAI) - https://www.hiv.gov/federal-response/smaif/overview

CDC Winnable Battles - https://www.cdc.gov/WinnableBattles/index.html The United States National HIV Strategy and National Strategic Plan (2021-2015) - HIV

National Strategic Plan (2021-2025) | HIV.gov HIV Care Continuum: https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Strategic

Plan through 2020 - https://www.cdc.gov/nchhstp/strategicpriorities/

All research activities should be consistent with CDC-supported programmatic guidance, scientific advances, and recommendations.

Relevant Work The research supported by this NOFO should address the following DHP priorities from the EHE Prevent Pillar:

1. Research on the real-world MSM community implementation of current and future approved forms of PrEP to improve effectiveness:

MSM consumer questions including factors affecting interest/ uptake/ adherence/ persistence, best support strategies for adherence/persistence, regimen preferences (such as for long-acting injectables, daily pills, event-based strategies, other delivery systems, multi-prevention technologies) and impact on uptake/adherence/persistence, patient preference for service delivery venue (e.g., in person provider, pharmacy, telehealth, home testing, mobile community services), differences by subgroups.

2. Research on MSM acceptability of new or improved biomedical, behavioral, or integrated HIV prevention interventions.

3. Research on factors associated with MSM contracting an infection in an era of multiple prevention options.

This NOFO builds upon previous and current HIV prevention research programs, including:

CDC NCHHSTP Research Contract No. 200-2021-53307 CDC NCHHSTP Cooperative Agreement PS15-002: Mobile Messaging Intervention to

Present New HIV Prevention Options for Men Who Have Sex With Men (MSM) - Full Text View - ClinicalTrials.gov

CDC NCHHSTP IDIQ Research Contract No. 200-2013-57341, RFTOP PR#2016-95482

Research from this NOFO should support CDC HIV prevention programs and initiatives.

2. Approach The recipient should conduct quarterly quantitative assessments in a diverse sample of a minimum of n=1275 HIV-negative MSM in three (3) US cities over two (2) years, including recruitment, enrollment, and retention of cohort members throughout the study period.

Quantitative behavioral assessment and message testing for HIV prevention are central activities, particularly assessment of sexual risk behavior and PrEP use and adherence. A subset of n=90 MSM should be administered qualitative in-depth interviews to explore PrEP use and adherence, including HIV prevention message development and testing to enhance prevention messaging efforts regarding PrEP. All MSM should receive alternating quarterly HIV and STD tests (i.e., an HIV test in one quarter, an STD test in the next quarter) and should be referred to prevention and treatment care as requested or needed. Rapid reports should be provided after each wave of quantitative and qualitative data collection, summarizing key findings, trends, and implications for public health messaging during a two (2)-year period.

To identify patterns of PrEP and condom use (and related gaps and opportunities for prevention messaging) of a diverse sample of sexually active MSM and reflect a transitional era for HIV prevention, it is critical that adequate numbers of MSM are enrolled and retained for quarterly assessments over a two (2)-year period. The study provides an important opportunity to develop and test prevention messages based on the behavioral patterns and issues observed, including quantitative and qualitative assessment of messages. A sample size adequate to achieve both of these purposes is necessary, and the application should propose a sample size calculation that clearly states the underlying assumptions and statistical methods used. For example, the sample size needed for a multi-group message testing design could have assumptions of 10-20% difference in pre-determined outcomes with a statistical test at the 5% significance level and minimum 80% statistical power to detect differences. The proposed sample size calculation should also reflect an expected annual attrition rate of 20%.

Objectives/Outcomes The study objectives are multifold:

1. To assess and better understand use of available HIV primary prevention products (e.g., daily oral PrEP, condoms) over time in a diverse community-based sample of MSM across three (3) US cities.

2. To assess and better understand HIV and STD infection rates in a transformational era for HIV prevention products among HIV-negative MSM.

3. To develop and test more effective HIV/STD prevention messages in an environment of an increasing number of HIV primary prevention products.

4. To analyze data and produce rapid reports following each wave of quantitative and qualitative assessment, reporting on key findings, trends, and recommendations for public health messaging and behavioral interventions.

Study outcomes for this NOFO should include research findings and recommendations based on:

1. Quarterly quantitative assessment of a diverse cohort of n=1275 HIV-negative MSM over two (2) years (total of eight [8] assessment waves), including developing rapid reports summarizing key findings and implications following each assessment wave:

HIV and STD testing Quantitative assessment of sexual risk behavior for HIV infection, consisting of condom and PrEP use and adherence Experience, perceptions, and preferences for using various forms of PrEP such as daily oral, event-based oral, injectable, and other formulations that are or becoming available for use

Timely, MSM community-related issues regarding PrEP use and adherence (e.g., PrEP medication sharing)

Demographic variables and other key factors associated with sexual risk behavior (e.g., substance use, mental health status)

Quantitative testing of new HIV prevention messages related to PrEP use and adherence

2. At least three (3) qualitative assessments (n=90, n=30 each) among a subsample of the diverse HIV-negative MSM study cohort delving deeper into HIV prevention messaging challenges and opportunities, particularly related to PrEP use and adherence to various products. Rapid reports with messaging recommendations should follow each qualitative assessment wave, as they should for each quantitative assessment wave.

3. Related presentations, abstracts, and manuscripts informing HIV prevention research and practice around the United States.

Target Population The community-based study sample should include a minimum of n=1275 MSM across three (3) study sites, which will represent three (3) regions of the United States (including one site in the US South). This cohort study should include a diverse population of n=1275 sexually active, HIV-negative cisgender MSM who are 18+ years old. The sample should also include a minimum of n=380 (~30%) Black/African American and n=380 (~30%) Hispanic/Latino MSM.

Based on PrEP use at enrollment, n=750 (~60%) should be MSM currently using PrEP at enrollment assessment, and n=525 (~40%) should not be currently using PrEP. All study materials and assessments should be offered in the English and Spanish languages, with bilingual staff support.

Collaboration/Partnerships This award is a collaboration between the recipient and prevention research and communications expertise within the CDC Division of HIV Prevention.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a four (4)-year research project period. The application should describe specific, measurable, achievable, realistic, and time-phased (SMART) project objectives for each activity described in the application’s project plan and describe the development and implementation of project performance measures based on specific programmatic objectives.

Specifically, SMART objectives should be developed for activities related to four (4) key aspects of this project:

1. Recruitment, enrollment, retention over two (2) years, and quarterly quantitative assessment of a diverse sample of a minimum of n=1275 MSM in three (3) US cities

(425 per city site) that represent three (3) distinct regions of the United States (including one in the US South). The assessment should focus largely on condom and PrEP product use and adherence, drug use and sexual risk behavior, related covariates and demographic variables, and development and testing of prevention messages to enhance HIV/STD protection.

2. HIV and STD staggered testing of a minimum of n=1275 participants that each test type (HIV, STI) should occur every six (6) months over a two (2)-year period, coinciding with a quantitative assessment. Test results should be linked to participants and used in study analysis, as well as providing results to participants as a service of the study.

3. Sample selection, materials development, and implementation of three (3) qualitative assessments (in depth interviews and focus groups; n=30 each wave) staggered approximately every six (6) months starting after completion of enrollment and baseline assessment of the quantitative survey. The qualitative assessments should focus on prevention gaps and opportunities identified, and development and testing of prevention messages to enhance HIV/STD protection.

4. Rapid reports after each assessment wave (quantitative, qualitative) providing key findings and recommendations for public health research and practice. To accomplish this, a rapid data cleaning, management, analysis, and writing infrastructure should be established for a two (2)-year period of managing the study data.

Translation Plan Ongoing assessment rapid reports are the basis for identifying prevention gaps and messaging opportunities for MSM. Expansion of those reports with further analysis, and then dissemination of those findings to prevention communities through written and oral presentation are critical for application of study findings. Implementation of prevention messaging findings to community prevention programs messaging activities (e.g., mobile apps, social marketing campaigns, website information sources, other written prevention materials) is a direct application of a strategy to improve HIV prevention for communities of MSM.

3. Funding Strategy N/A

Section II. Award Information Funding Instrument Type:

CA (Cooperative Agreement) A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding:

$5,900,000

Estimated Total Annual Budget Period Funding:

Year 1: $1,475,000 Year 2: $1,475,000 Year 3: $1,475,000 Year 4: $1,475,000

Anticipated Number of Awards:

Estimated total funding available for the first year (first 12 months), including direct and indirect costs: $1,475,000 Estimated total funding available for the entire project period, including direct and indirect costs: $5,900,000

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling:

$1,475,000 Per Budget Period

Award Floor:

$1,400,000 Per Budget Period

Total Period of Performance Length:

4 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

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

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility The following types of Higher Education Institutions are always encouraged to apply for

CDC support as Non-profit Public or Non-profit Private Institutions of Higher Education:

o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education) Private Non-profit Institutions of Higher Education Eligible Agencies of the Federal Government Faith-based or Community-based Organizations U.S. Territory or Possession Regional Organizations Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms."

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency’s existing in-house or contractor resources. FFRDC’s enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR

4. Justification for Less than Maximum Competition N/A

5. Responsiveness If an application requests a funding amount greater than the ceiling of $1,475,000, including direct and indirect costs, as indicated in Section II. of this NOFO, HHS/CDC will consider the application non-responsive and it will not enter the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

PLEASE NOTE: For applications due on or after January 25, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission. Grant application forms and instructions will be updated to reflect and require UEI instead of DUNS.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code:

https://eportal.nspa.nato.int/AC135Public/Docs/US Instructions for NSPA NCAGE.pdf

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, SAM.gov.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The one-time registration process will take three to five days to complete.

However, it is best to start the registration process at least two weeks prior to application submission.

All Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have an active eRA Commons account in order to prepare an application.