rfa-ce-25-149_v2.pdf

Division of Overdose Prevention

Notice of Funding Opportunity

Application due December 2, 2024

Rigorous Evaluation of Primary and Secondary Overdose Prevention Activities Among Populations Disproportionately Affected by Overdose Opportunity number: RFA-CE-25-149

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 8

Program description 11

Step 2: Get Ready to Apply 26

Get registered 27

Step 3: Prepare Your Application 29

Application contents and format 30

Step 4: Learn About Review and Award 35

Application review 36

Award notices 45

Step 5: Submit Your Application 46

Application submission and deadlines 47

Step 6: Learn What Happens After Award 50

Post-award requirements and administration 51

Contacts and Support 55

Endnotes 58

Contents 2

Before you begin If you believe you are a good candidate for this funding opportunity, secure your SAM.gov and Grants.gov registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks) You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI).

See Step 2: Get Ready to Apply

Grants.gov registration (this can take several days) You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get Ready to Apply

Apply by December 2, 2024 Applications are due by 11:59 p.m. Eastern Time on December 2, 2024.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command + Left Arrow (Mac) on your keyboard.

Before you begin 3 https://sam.gov/ https://grants.gov/

Jump to a step

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 8

Program description 11

Basic information Centers for Disease Control and Prevention

National Center for Injury Prevention and Control

Division of Overdose Prevention

Rigorously evaluate overdose prevention activities.

Have questions?

See Contacts and Support.

Key facts

Opportunity name: Rigorous Evaluation of Primary and Secondary Overdose Prevention Activities Among Populations Disproportionately Affected by Overdose

Opportunity number: RFA-

CE-25-149

Activity code: U01

Funding activity category: HL

— Health

Federal assistance listing:

93.136

Key dates

Application deadline:

December 2, 2024

Optional letter of intent deadline: November 4, 2024

Informational call: October 10, 2024, at 2 p.m. ET

Expected scientific review date: March 25, 2025

Expected secondary review date: May 7, 2025

Expected award date: August 29, 2025

Expected start date:

September 30, 2025

Expiration date: March 7, Summary This NOFO funds research focused on people experiencing disproportionate burden of drug overdose, those who are at greater risk of exposure to drug use, or those experiencing adverse drug use outcomes related to social determinants of health.

Your research should rigorously evaluate either primary or secondary prevention strategies for reducing rates of nonfatal overdose, fatal overdose, and/or substance use disorders involving federally illegal drugs or misuse of prescription medications, drug use, or initiation of drug use, particularly among youth.

Funding details Instrument type: Cooperative Agreement

Application type: New

Expected total program funding over the performance period: Up to $24,500,000

Expected total program funding per budget period: Up to $4,900,000

Expected number of awards: Up to 7

Maximum Funding per budget period: $700,000

Expected average award amount per budget period: $700,000

We plan to offer two funding options for this Notice of Funding Opportunity.

You may submit a research proposal under either Funding Option A or Funding Option B.

Step 1: Review the Opportunity 5

Funding option A Funding option A will support research projects that support implementation and rigorous evaluation of prevention activities.

These projects will be funded up to $350,000 per 12-month budget period for up to 3 years.

The period of performance is expected to be September 30, 2025, to September 30, 2028, for three-year awards.

Funding option B Funding option B will support research projects that support development, implementation, and rigorous evaluation of prevention activities.

These projects will be funded up to $700,000 per 12-month budget period for up to 5 years.

The period of performance is expected to be September 30, 2025, to September 29, 2030, for five-year awards.

You must clearly indicate in the abstract whether your research proposal falls under:

• Funding option A: Implement and rigorously evaluate strategies (3-year award)

• Funding option B: Develop, implement, and rigorously evaluate strategies (5-year award)

The number of awards is subject to available funds and program priorities.

Number of applications You may submit more than one application if each application is scientifically distinct.

However, applicant institutions can submit only one grant application with the same principal investigator in response to this NOFO. Only one application per principal investigator will be reviewed or funded under this announcement, regardless of funding option selected.

If two or more applications from the same PI are received, the only application that will be submitted for review will be the last application received based on the document’s time and date stamp in Grants.gov

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 6 https://grants.nih.gov/grants/rppr/index.htm

Additionally, applicant institutions submitting applications with essentially the same proposed research to two or more CDC NOFOs will not be funded under more than one NOFO.

You must ensure that duplicate applications are withdrawn prior to the application review date.

Step 1: Review the Opportunity 7

Eligibility Eligible applicants Only the following types of organizations may apply. State, territorial, local, and tribal government organizations may also opt to select a bona fide agent to apply on their behalf:

• State governments

• County governments

• City or township governments

• Special district governments

• Independent school districts

• Public and state-controlled institutions of higher education

• Private institutions of higher education

• Native American tribal governments (federally recognized)

• Public housing authorities and Indian housing authorities

• Native American tribal organizations other than federally recognized tribal governments

• Nonprofits with 501(c)(3) status other than institutions of higher education

• Nonprofits without 501(c)(3) status other than institutions of higher education

• For-profit organizations other than small businesses

• Small businesses

Bona fide agents must submit documentation that demonstrates their arrangement with the eligible applicant. See other attachments.

Other required responsiveness factors The following additional factors must be addressed in your application to qualify for funding under this NOFO. Please see also Initial Review.

• The proposed research should rigorously evaluate either primary or secondary prevention strategies, on reducing rates of at least two required outcomes from this list: nonfatal overdose, fatal overdose, substance use disorders involving federally illegal drugs or misuse of prescription medications, drug use, or initiation of drug use, particularly in youth. Applications that do not propose to develop, Step 1: Review the Opportunity 8 implement, and rigorously evaluate or implement, and rigorously evaluate strategies that (1) prevent adverse outcomes related to drug use among those not yet engaged in it (i.e., primary prevention) or (2) reduce adverse outcomes among those already engaged in drug use by linking them to and retaining them in care (i.e., secondary prevention), as evidenced in the Research Strategy section of the application’s research plan, will be considered nonresponsive and will not be forwarded for peer review.

• The proposed research should not focus on measures of alcohol use disorder only, alcohol use only, tobacco use disorder only, or tobacco use only. Applications that do not propose to measure federally illegal drugs or prescription medications, or substance use disorders not involving federally illegal drugs or misuse of prescription medications as a required outcome will be considered nonresponsive and will not be forwarded for peer review.

• The proposed research must employ rigorous evaluation designs (i.e., experimental, quasi-experimental) that include a control/comparison group. Applications that do not include a control/comparison group or do not propose an experimental or quasi-experimental design, as evidenced in the Research Strategy section of the application’s research plan will be considered nonresponsive and will not be forwarded for peer review.

• The proposed research must not focus on law enforcement strategies without inclusion of a strong public health component, as a primary research aim. Applications that propose to focus on law enforcement strategies without a public health component or focus, as evidenced in the Research Strategy section of the application’s research plan, will be considered nonresponsive and will not be forwarded for peer review.

• The proposed research must focus on human subjects. Applications proposing research using non-human species, as evidenced in the Research Strategy section of the application’s research plan, will be considered nonresponsive and will not be forwarded for peer review.

• The proposed budget for each fiscal year must be less than or equal to the budget ceiling outlined in the Funding Details section. Applications that exceed the budget in any year will be considered nonresponsive and will not be forwarded for peer review.

• Applicants must include required documentation that meets the following PD or PI/Co-PI requirements:

◦ The SF-424 Biographical Sketch for the PD, PI or Co-Investigator(s) must include documentation of expertise in substance use, substance use disorders, or overdose that is reflected in the

Step 1: Review the Opportunity 9 application’s research strategy section. The knowledge, experience, and expertise necessary to conduct this research and achieve proposed objectives must be documented with either of the following:

◦ At least one first-authored, peer-reviewed publication as defined by the NIH National Library of Medicine in the relevant area of substance use, substance use disorders, or overdose

◦ By serving as a PD, PI, or co-PI on a research grant in substance use, substance use disorders, or overdose

◦ Experience requirements may be demonstrated through the combined experiences of a PI and Co-PI (if applicable). The citation of the relevant publication(s) or research experience must be clearly identified (by bold text or highlight) in the appropriate SF 424 Biographical Sketch.

◦ Applications that do not include documentation to meet this PI/co-PI requirement will be considered nonresponsive and will not be forwarded for peer review.

Eligible project directors and principal investigators We invite anyone who has the educational background, skills, knowledge, and resources necessary to carry out the proposed research as a project director or principal investigator (PD/PI) to work with their organization or institution to apply for support.

We encourage people from underrepresented groups to apply, such as people from underrepresented racial, ethnic, sexual orientation and gender identity groups, and those with disabilities.

Please refer to PI criteria in the “Investigators” section of Scored Criteria.

Cost sharing and matching funds This program has no cost-sharing or matching funds requirement. We will not consider cost-sharing fund contributions during your application review.

However, if you choose to submit voluntary cost-sharing funds in your application, and we fund the award, we will require you to report on these funds.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 10 https://www.nlm.nih.gov/nichsr/stats_tutorial/section3/mod6_peer.html

Program description Background and purpose In 2022, drug overdose deaths surpassed 100,000.[1] Death rates increased among both sexes, all adults above age 25, and all races and Hispanic-origin groups except non-Hispanic Asian people. Rates of overdose deaths in 2022 varied among demographic groups, and percentage increases varied from 2021 to 2022, suggesting disproportionate burden of fatal overdose across groups.[2] The intersection of demographic characteristics is also important:

data from 25 states and the District of Columbia showed that overdose death rates were higher in counties with higher income inequality ratios, and disparities were starker for Black and Hispanic people.[3]

Exposure to drug use and other adverse outcomes of drug use vary. For example, adverse family conditions and certain social network characteristics (such as lack of social support or a peer network that uses substances) are associated with initiation of substance use, and the influence of these experiences may be modified by characteristics such as age, race, socioeconomic status, and sex.[4] [5] Community characteristics such as neighborhood disadvantage, unemployment rates, and witnessing high-risk events such as arrests correlate with initiation of drug use.[6] [7]

Similarly, access to substance use treatment is unequal across population groups. For example, data from 25 states show that among overdose decedents in 2019 and 2020, Black, Hispanic, and American Indian/Alaskan native persons had the lowest proportions of documented evidence of substance use treatment.[8] Community characteristics such as ease of access to drugs are associated with returning to drug use.[9]

Research suggests that some people may have a greater risk for exposure to drug use. These people include children and young adults growing up in a home where adults were negatively impacted by substance use[10] [11] and children with adverse childhood experiences more broadly.[12] Additionally, children with behavioral disorders such as conduct disorder may be more likely to engage in risky substance use later in life.[13] [14] A bidirectional association between chronic pain and substance use[15] potentially places people in pain at higher risk of adverse outcomes related to drug use, and pain is the most frequently reported reason for prescription pain reliever misuse.[16] Groups that have been economically or socially marginalized can also be at greater risk for substance use and related harms in relation to

Step 1: Review the Opportunity 11 racism and discrimination[17] or witnessing community violence.[18] Primary prevention strategies among these groups that reduce exposure to drug use and enhance buffers against drug use and adverse outcomes are needed.

Research suggests that some people may be at greater risk compared to other groups for drug overdose or for adverse drug use outcomes related to social determinants of health and experiences and conditions that occur after drug use and impede access to treatment and recovery. People who are not treated for overdoses in emergency departments or other medical facilities may not be linked to harm reduction services or evidence-based care.[19] [20] [21] Parents with substance use disorder may not seek care due to fear of child removal or the inability to reside with their children during treatment. [22] [23] Those who have been recently incarcerated are at greater risk of overdose post-release and can benefit from strategies that serve them once they re-enter the community.[24] [25] People who inject drugs may be deterred from accessing treatment potentially because of stigma[26] and may need access to specialists who address medical consequences specific to injection drug use.[27] Some pregnant persons may be less likely to be screened for substance use disorder,[28] also potentially from stigma,[29] and many who need treatment do not receive it[30] despite increased admissions.[31]

People with both mental health conditions and substance use disorders report lower percentages of treatment for their conditions than do people who report only one of these diagnoses.[32] They also face negative outcomes including returning to use[33] [34] and may benefit from integrated treatment.[35] Persons experiencing homelessness often lack health care because basic needs like food and shelter come first[36] and untreated substance use disorders may be common. Treatment services may be limited at clinics that serve persons experiencing homelessness.[37] Secondary prevention strategies to identify and effectively link these groups to and retain them in evidenced-based care are needed.

The Centers for Disease Control and Prevention’s (CDC) National Center for Injury Prevention and Control (NCIPC) solicits investigator-initiated research on overdose prevention strategies. This research should focus on people experiencing a disproportionate burden of drug overdose, those who are at greater risk of exposure to drug use, or those experiencing adverse drug use outcomes related to social determinants of health.

Funding can be used to develop, implement, and rigorously evaluate strategies to prevent drug-related adverse outcomes among those not yet

Step 1: Review the Opportunity 12 engaged in drug use (primary prevention), or reduce adverse outcomes among those already engaged in drug use by linking them to and retaining them in care (secondary prevention).

Healthy People 2030 This research addresses the Healthy People 2030 focus areas of Substance Use and Injury Prevention. Specifically, this NOFO supports the following Healthy People Substance Use (SU) areas:

• SU-01: Increase the proportion of people with a substance use disorder who got treatment in the past year

• SU-03: Reduce drug overdose deaths

• SU-07: Reduce the proportion of adults reporting use of any illicit drugs during the past 30 days

• SU-15: Reduce the proportion of people with illicit drug use disorder in the past year.

This research also supports the Healthy People Injury Prevention (IVP) area of IVP-20: Reduce overdose deaths involving opioids, and IVP-03: Reduce unintentional injury deaths.

Public health impact The proposed research is expected to expand the evidence base for primary and secondary prevention of drug-use outcomes, identified as required outcomes in the Approach section. It will focus on people most at risk for exposure to drugs and most affected by drug overdose or adverse outcomes related to drug use.

Related work This work addresses the following focus areas in the strategic plan for NCIPC’s Division of Overdose Prevention:

• Increase rigorous evaluation, applied research, and opportunities for linking and retaining persons with disproportionate risk for overdose and adverse outcomes related to substance use to harm reduction services, evidence-based treatment, and recovery support services.

• Identify and address shared risk and protective factors associated with substance use initiation and misuse and other comorbidities across the prevention continuum, including mental health and well-being.

This proposal also aligns with the current research priorities of the Division of Overdose Prevention.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 13 https://health.gov/healthypeople

This project addresses the following research priority:

• Develop and evaluate innovative prevention strategies designed to prevent overdose, including among those at greatest risk.

This works complements the following programmatic efforts from the Division of Overdose Prevention:

• CDC funded 66 jurisdictions as part of its Overdose Data to Action Program, a cooperative agreement that began in September 2019. The program focuses on the complex and changing nature of the overdose epidemic, including stimulant overdoses, and highlights the need for an interdisciplinary, comprehensive, and cohesive public health approach to preventing overdoses. In 2023, CDC released two new funding opportunities, one for states (Overdose Data to Action in States) and one for localities and territories (Overdose Data to Action: Limiting Overdose through Collaborative Actions in Localities), to help ensure broad resources and support to respond to the evolving overdose crisis. Both awards support five-year cooperative agreements to expand and strengthen overdose surveillance and prevention efforts to reduce fatal and nonfatal overdoses involving opioids, stimulants, or polysubstance use. A total of 90 jurisdictions were funded.

• In partnership with the Office of National Drug Control Policy (ONDCP), CDC supports more than 750 community coalitions across the country to prevent and reduce substance use among youth through its Drug-Free Communities Support Program.

The following publications from Division of Overdose Prevention authors have been recently released:

Increased Risk of Exposure

• Harper CR, Li J, Sheats K, et al. Witnessing Community Violence, Gun

Carrying, and Associations with Substance Use and Suicide Risk Among High School Students — Youth Risk Behavior Survey, United States, 2021.

MMWR Suppl 2023;72(Suppl-1):22–28. DOI: http://dx.doi.org/10.15585/ mmwr.su7201a3

• Rikard, SM, Strahan, AE, Schmit, KM, Guy, GP Jr. Chronic Pain Among Adults — United States, 2019–2021. MMWR Morb Mortal Wkly Rep 2023;72:379–385. DOI: http://dx.doi.org/10.15585/mmwr.mm7215a1

• Stokes EK, Pickens CM, Wilt G, Liu S, David F. County-level social vulnerability and nonfatal drug overdose emergency department visits and hospitalizations, January 2018-December 2020. Drug Alcohol

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 14 https://www.cdc.gov/overdose-prevention/php/od2a/about.html?CDC_AAref_Val=https://www.cdc.gov/drugoverdose/od2a/about.html https://www.cdc.gov/overdose-prevention/php/od2a/about.html?CDC_AAref_Val=https://www.cdc.gov/drugoverdose/od2a/about.html https://www.cdc.gov/overdose-prevention/php/od2a/about.html https://www.cdc.gov/overdose-prevention/php/drug-free-communities/index.html https://www.cdc.gov/overdose-prevention/php/drug-free-communities/index.html https://www.cdc.gov/mmwr/volumes/72/su/su7201a3.htm?s_cid=su7201a3_w https://www.cdc.gov/mmwr/volumes/72/su/su7201a3.htm?s_cid=su7201a3_w https://www.cdc.gov/mmwr/volumes/72/su/su7201a3.htm?s_cid=su7201a3_w http://dx.doi.org/10.15585/mmwr.su7201a3 http://dx.doi.org/10.15585/mmwr.su7201a3 https://www.cdc.gov/mmwr/volumes/72/wr/mm7215a1.htm?s_cid=mm7215a1_w https://www.cdc.gov/mmwr/volumes/72/wr/mm7215a1.htm?s_cid=mm7215a1_w http://dx.doi.org/10.15585/mmwr.mm7215a1 https://www.sciencedirect.com/science/article/pii/S0376871623001278 https://www.sciencedirect.com/science/article/pii/S0376871623001278 https://www.sciencedirect.com/science/article/pii/S0376871623001278

Depend. 2023 Jun 1;247:109889. DOIO: https://doi.org/10.1016/ j.drugalcdep.2023.109889. Epub 2023 Apr 23. PMID: 37148633.

• Jiang X, Govoni TD, Illg Z, Connolly S, et al. Sources of nonmedically used prescription psychotherapeutic drugs using real-world data from adolescents and adults assessed for substance use treatment–2014-2022. Research in Social and Administrative Pharmacy.

2023. DOI: https://doi.org/10.1016/j.sapharm.2023.10.014

Increased Risk of Adverse Outcomes Related to Social Determinants of Health

• Terranella A, Guy G, Strahan A, Mikosz C. Out-of-Pocket Costs and Payer Types for Buprenorphine Among US Youth Aged 12 to 19 Years. JAMA Pediatrics. 2023;177(10):1096–1098. DOI: 10.1001/ jamapediatrics.2023.2376

• Kariisa M, Davis NL, Kumar S, et al. Vital Signs: Drug Overdose Deaths, by Selected Sociodemographic and Social Determinants of Health Characteristics — 25 States and the District of Columbia, 2019–2020.

MMWR Morb Mortal Wkly Rep. ePub: 19 July 2022. DOI: http://dx.doi.org/ 10.15585/mmwr.mm7129e2

Secondary Prevention

• Worthington, N, Gilliam, T, Mital, S. First Responder Assertive Linkage

Programs: A Scoping Review of Interventions to Improve Linkage to Care for People Who Use Drugs. Journal of Public Health Management and Practice. 28(Supplement 6):S302-S310, November/December 2022. DOI:

https://doi.org/10.1097/phh.0000000000001611

• Joshi S, Rivera BD, Cerdá M, et al. One-Year Association of Drug Possession Law Change With Fatal Drug Overdose in Oregon and Washington. JAMA Psychiatry. 2023;80(12):1277–1283. DOI: 10.1001/ jamapsychiatry.2023.3416

Approach Strategy focus: Primary or secondary prevention There are two applicable funding options for this research:

• Funding option A: Implement and rigorously evaluate strategies (3-year award)

• Funding option B: Develop, implement, and rigorously evaluate strategies (5-year award)

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 15 https://www.sciencedirect.com/science/article/abs/pii/S1551741123004667 https://www.sciencedirect.com/science/article/abs/pii/S1551741123004667 https://www.sciencedirect.com/science/article/abs/pii/S1551741123004667 https://www.sciencedirect.com/science/article/abs/pii/S1551741123004667 https://doi.org/10.1016/j.sapharm.2023.10.014 https://jamanetwork.com/journals/jamapediatrics/fullarticle/2808110 https://jamanetwork.com/journals/jamapediatrics/fullarticle/2808110 https://jamanetwork.com/journals/jamapediatrics/fullarticle/2808110 https://jamanetwork.com/journals/jamapediatrics/fullarticle/2808110 https://www.cdc.gov/mmwr/volumes/71/wr/mm7129e2.htm?s_cid=mm7129e2_w https://www.cdc.gov/mmwr/volumes/71/wr/mm7129e2.htm?s_cid=mm7129e2_w https://www.cdc.gov/mmwr/volumes/71/wr/mm7129e2.htm?s_cid=mm7129e2_w http://dx.doi.org/10.15585/mmwr.mm7129e2 http://dx.doi.org/10.15585/mmwr.mm7129e2 https://journals.lww.com/jphmp/Fulltext/2022/11001/First_Responder_Assertive_Linkage_Programs__A.8.aspx https://journals.lww.com/jphmp/Fulltext/2022/11001/First_Responder_Assertive_Linkage_Programs__A.8.aspx https://journals.lww.com/jphmp/Fulltext/2022/11001/First_Responder_Assertive_Linkage_Programs__A.8.aspx https://doi.org/10.1097/phh.0000000000001611 https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2809867 https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2809867 https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2809867 https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2809867 https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2809867

You must rigorously evaluate primary or secondary prevention strategies for drug use outcomes. For this NOFO, drug use is defined as use of federally illegal drugs (e.g., heroin, cocaine, methamphetamine, psilocybin, cannabis) or misuse of prescription medications (i.e., use in any way not directed by a doctor, including use of someone else’s prescription; use in greater amounts, more often, or longer than recommended; or use in any other way not directed by a doctor). “Drug use outcomes” include measures such as overdose (nonfatal and/or fatal), substance use disorders, drug use, and initiation of drug use, particularly in youth.

For this NOFO, primary prevention strategies are for people not yet engaged in drug use who are at greater risk of exposure to drug use or experiencing adverse drug use outcomes related to social determinants of health (e.g., children of families with intergenerational drug use as well as those with mental health conditions or behavioral disorders, people with chronic pain, children and adults who have experienced trauma, people experiencing poverty or violence in their neighborhoods, or lack of economic opportunity) on reducing rates of at least two required outcomes (See Objectives and Outcomes).

For this NOFO, secondary prevention strategies should include linkage to and retention in care for people already engaged in drug use who are experiencing disproportionate burden of drug overdose or who are at greater risk of experiencing adverse drug use outcomes related to social determinants of health, like people who experience nonfatal overdoses and do not receive care at an emergency department, persons leaving incarceration, persons who inject drugs, parents who may fear child removal, pregnant persons, people with co-occurring mental health conditions and substance use disorders involving federally illegal drugs or misuse of prescription medications, and people experiencing homelessness on reducing rates of at least two required outcomes (See Objectives and Outcomes).

Care is defined as evidence-based treatment for opioid use disorder (OUD) (i.e., buprenorphine, methadone, naltrexone) alone or in combination with behavioral health strategies (such as counseling, motivational interviewing, cognitive behavioral therapy). While currently there are no FDA-approved medications to treat stimulant use disorder, there are evidence-based behavioral health strategies (i.e., motivational interviewing, contingency management, community reinforcement approach, and cognitive behavioral therapy).

Step 1: Review the Opportunity 16

Objectives and outcomes This section includes outcomes you are expected to report progress on and achieve within the period of performance if you receive funding.

Your research should rigorously evaluate either primary or secondary prevention strategies for reducing rates or counts of at least two required outcomes from this list:

• Nonfatal overdose

• Fatal overdose

• Substance use disorders involving federally illegal drugs or misuse of prescription medications

• Drug use

• Initiation of drug use, particularly in youth

Measurement of your two selected required outcomes should include rates and/or counts. Additionally, you are encouraged to include the following under your required outcomes (where applicable):

• Drug(s) involved in nonfatal overdose

• Drug(s) involved in fatal overdose

• The specific type(s) of drugs involved in substance use disorders

• Current drug use

• Frequency of drug use

• Types of drug(s) use

• Route(s) of drug administration

• Age of initiation of drug use

• Types of drug(s) used at initiation

Note: Measures of alcohol use disorder only, alcohol use only, tobacco use disorder only, or tobacco use only are not applicable under this NOFO.

The measurement of optional outcomes, though not required, can also be included. Secondary outcomes can include correlates of drug use or overdose morbidity and mortality, or variables that impact the association between those outcomes and the strategy (e.g., potential mediators or moderators).

This could include but is not limited to social determinants of health, substance use disorder treatment initiation, changes to behaviors related to drug use, other potential mediators of the association between the strategy and the outcome, and moderators of the association between the strategy

Step 1: Review the Opportunity 17 and the outcomes. These should also be incorporated into the Theory of Change section.

Research design For this NOFO, rigorous evaluation designs must include a control/ comparison group and are defined as either:

• Experimental (i.e., randomized controlled trials)

• Quasi-experimental (e.g., comparative interrupted time series design, difference-in-differences, instrumental variable methods, regression discontinuity, regression point displacement, stepped wedge, designs using propensity-score matching, designs involving matched comparison groups)

Theory of change You should provide a theory of change that clearly links how the strategy is expected to influence at least two required outcomes. The theory of change should include, as appropriate, process or implementation measures.

Additionally, risk and protective factors for overdose at multiple levels of the social ecology may serve as mediators of the association between the strategy and the outcomes as well as factors that may function as moderators of the association between the strategy and the outcomes should be identified (Baron and Kenney, 1986). Including such variables can help us understand how implementation and contextual factors affect achieving the strategy’s intended outcomes. Additionally, you are encouraged to include the following: implementation measures such as barriers and facilitators; the extent to which the strategy was implemented as planned; and acceptability of the population impacted by the strategy. These elements can contribute to understanding the strategy’s differential impacts and potential scalability.

Specifically, the theory of change should describe:

• The strategy focus (i.e., primary or secondary)

• How the strategy is suited or tailored to serve the selected population

• How the strategy could affect rates or counts of at least two required outcomes

Data collection, acquisition, and analysis You must identify and describe appropriate data sources and provide evidence of your ability to acquire and/or collect data of sufficient quantity and quality within the period of performance. Your application should clearly describe and justify the proposed sampling methods, sample size, power

Step 1: Review the Opportunity 18 estimates, and data collection methods for the required outcome(s), at a minimum, and subgroup analyses. You must specify the timeline for data acquisition (requests for extant data and or primary data collection).

Numerous data sources can be used for the outcome data, including emergency department data, emergency medical services data, electronic health records, mortality data (e.g., vital statistics or medical examiner/ coroner report data), survey data, and/or other sources of data. Appropriate data sources will vary by the proposed research approach and outcome measures.

Focus populations For this NOFO, people experiencing disproportionate burden of drug overdose, those who are at greater risk of exposure to drug use, or those experiencing adverse drug use outcomes related to social determinants of health should be selected and identified using at least one of the following:

• Meta-analyses or systematic reviews that indicate disproportionate burden of overdose and/or are at greater risk of exposure to drug use or experiencing adverse drug use outcomes related to social determinants of health.

• Multiple observational studies from U.S. settings that indicate disproportionate burden of overdose and/or greater risk of exposure to drug use or experiencing adverse drug use outcomes related to social determinants of health.

• Formative research showing disproportionate burden of overdose or greater risk of exposure to drug use or experiencing adverse drug use outcomes related to social determinants of health.

Equal opportunities This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of, race, color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy) or other constitutionally protected statuses.

Health disparities The goal of health equity is for everyone to have a fair and just opportunity to attain their highest level of health. Health disparities are often caused by social determinants that influence which people are most disproportionately affected by health conditions.

A health disparity is a difference in health burdens between groups of people with differing social determinants of health.

Step 1: Review the Opportunity 19

Social determinants of health are conditions in the environments where people are born, live, learn, work, play, worship, and age. These determinants affect a wide range of health, functioning, and quality-of-life outcomes and risks.

For more information on people experiencing a disproportionate burden of drug overdose, please see Overdose Prevention Research Priorities 2022 (cdc.gov). Adverse drug use outcomes related to social determinants of health include lack of access to evidence-based substance use disorder treatment and other resources that can support recovery.

Collaborations and partnerships We expect that for all applications, your organization and contact PD/PI will provide the scientific and technical leadership necessary to conduct the proposed research throughout the entire period of performance. We expect that the proposed research work plan described in the Research Strategy section of the application and the SF-424 Research and Related Budget will demonstrate your organization’s leadership and involvement throughout the entirety of the period of performance. Your organization cannot serve as a “pass through” to fund another entity to conduct the majority of the research or provide the scientific or technical leadership necessary to complete the proposed research project.

NCIPC recognizes the importance of community conditions and community-centered research to complete the proposed work. We strongly encourage you to seek and include the meaningful involvement of communities, including state and/or local health departments, local governmental agencies and/or businesses, and community-based organizations in all phases of the research, translation, and dissemination of research results. This may include strong partnerships with community members with lived experience who participate in all phases of the research (e.g., developing study methods, collecting data, interpreting results, and disseminating findings).

Partnerships between the applicant institution and outside entities may be necessary or advantageous to complete the proposed work. Your application must clearly describe each partnering entity’s roles and responsibilities. This includes demonstrating your access to planned data sources and study populations, and all partnerships necessary to complete the project.

The Research Strategy section of the application is expected to clearly describe the roles and responsibilities of each research team member individually and each participating entity. This includes describing how the partnership will allow you to complete the proposed work. The Research

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 20 https://www.cdc.gov/about/priorities/social-determinants-of-health-at-cdc.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html https://www.cdc.gov/injury/healthequity/hearc/test/pdf/Research-Priorities-Overdose_508.pdf https://www.cdc.gov/injury/healthequity/hearc/test/pdf/Research-Priorities-Overdose_508.pdf

Strategy section must describe the nature and extent of the proposed partnership, including:

• The roles and responsibilities of the Project Director(s)/Principal Investigator(s) and of the outside entities or partner agencies.

• The existing working relationship.

• The nature and extent of the involvement to be provided by the applicant institution and outside entity for the proposed research.

• The outside entity’s scope of work.

• How the partnership will ensure implementation and sustainability of the proposed evaluation.

The Research Strategy section must describe all data sources and the partnerships that are in place to ensure data access for all proposed analyses are completed within the period of performance.

Each partnering entity’s roles and responsibilities must be substantiated with a signed Data Sharing Agreement, Letter or Support (LOS), or Memorandum of Understanding (MOU), and be included in your application’s LOS section.

The Data Sharing Agreement, LOS, or MOU must describe the partner’s resources, time, and personnel commitments to the proposed research.

Applications that do not include a signed Data Sharing Agreement, LOS, or MOU from each partnering entity may not be recommended for funding.

Translation plan You should describe the potential for widespread use of your research results and the potential to translate the results with and for community partners.

You should also include plans to document relevant strategy implementation methods and lessons learned to facilitate future replication in another research or non-research setting if the strategy is effective. These plans may include but are not limited to identifying the core components of the strategy and documenting lessons learned from the study that might inform decisions about future adaptation or modification for other settings or populations.

Your application should describe the strategy’s scalability as part of the translation plan. Research findings should be disseminated through publications, including articles in peer reviewed scientific journals, and “Research Briefs” for diverse audiences (e.g., policy makers, public health programs, community groups), as well as presentations at professional conferences and in institutional and community-based venues.

Step 1: Review the Opportunity 21

The PD/PI should describe how the findings may be used to address key drivers of health inequities (e.g., through focusing on disproportionately affected people). The description should include consideration of structural inequalities.[38]

Cooperative agreement recipients will be required to attend one reverse site visit per year in Atlanta with CDC/NCIPC staff during the performance period to review their progress and findings and to discuss opportunities for widespread dissemination of their research achievements and lessons learned. Travel costs for attending this meeting must be included in your travel budget submitted in response to this NOFO.

Funding policies and limitations General guidance

• Your budget is arranged in eight categories: salaries and wages, fringe benefits, consultant costs, equipment, supplies, travel, other, and contractual.

• You may use funds only for reasonable program purposes consistent with the award, its terms and conditions, and federal laws and regulations that apply to the award. Questions about this determination should be posed to the grants management specialist.

• Generally, you may not use funds to purchase furniture or equipment.

Clearly identify and justify any such proposed spending in the budget.

Unallowable costs You may not use funds for:

• Clinical care except as allowed by law.

• Pre-award costs unless CDC gives you prior written approval.

• Other than for normal and recognized executive-legislative relationships:

◦ Publicity or propaganda purposes, including preparing, distributing, or using any material 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 Anti-Lobbying Restrictions for CDC Recipients.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 22 http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf

Indirect costs Indirect costs are those for a common or joint purpose across more than one project and that cannot be easily separated by project. Learn more at 45 CFR 75.414, Indirect Costs and CDC Budget Preparation Guidelines.

To charge indirect costs you can select one of two methods:

Method 1 – Approved rate. You currently have an indirect cost rate approved by your cognizant federal agency.

Justification: Provide a summary of the rate. Enclose a copy of the current approved rate agreement in the Attachments.

Method 2 – De minimis rate. Per 45 CFR 75.414(f), if you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate. If you are awaiting approval of an indirect cost proposal, you may also use the de minimis rate. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs.

This rate is 10% of modified total direct costs (MTDC). See 45 CFR 75.2 for the definition of MTDC. You can use this rate indefinitely.

Other indirect cost policies As described in 45 CFR 75.403(d) and 45 CFR 75.414, you must consistently charge items as either indirect or direct costs and may not double charge.

• Indirect costs may include the cost of collecting, managing, sharing, and preserving data.

• Indirect costs on grants awarded to foreign organizations and foreign public entities and performed fully outside of the territorial limits of the U.S. may be paid to support the costs of compliance with federal requirements. The indirect cost rate is fixed at eight percent of modified total direct costs.

• Negotiated indirect costs may be paid to the American University, Beirut, and the World Health Organization.

• Indirect costs on training grants are limited to a fixed rate of eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and sub-awards in excess of $25,000.

• If requesting indirect costs in the budget based on a federally negotiated rate, you must attach a copy of the indirect cost rate agreement. See other attachments form.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 23 https://www.ecfr.gov/current/title-45/section-75.414 https://www.ecfr.gov/current/title-45/section-75.414 https://www.cdc.gov/grants/documents/budget-preparation-guidance.pdf https://www.ecfr.gov/current/title-45/part-75#p-75.414(f) https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC)) https://www.ecfr.gov/current/title-45/part-75#p-75.403(d) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-E/subject-group-ECFR1eff2936a9211f7/section-75.414 https://www.ecfr.gov/current/title-45/part-75#p-75.2(Modified%20Total%20Direct%20Cost) https://www.ecfr.gov/current/title-45/part-75#p-75.2(Modified%20Total%20Direct%20Cost)

Expanded authority For more information on expanded authority and pre-award costs, see the HHS Grants Policy Statement and speak to the grants management contact.

Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.

Public health data We require that awards include mechanisms for, and the costs of, public health data sharing. You may also include the reasonable cost of sharing or archiving public health data as part of the total budget requested for first-time or continuation awards. For more information, please see Additional Requirement – 25 | Grants | CDC.

Human subjects We will restrict funds related to conducting research involving human subjects until the appropriate assurances and Institutional Review Board (IRB) approvals are in place. To lift the restrictions, we will require copies of all current local IRB approval letters, local IRB-approved protocols, and CDC IRB approval letters, when applicable.

If the proposed research project involves more than one institution and will be conducted in the United States, we expect you to:

• Use a single Institutional Review Board (sIRB) to conduct the required ethical review.

• Include a single IRB plan in your research plan and PHS Human Subjects and Clinical Trials Information form, unless review by a sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy or you provide a compelling justification based on ethical or human subject protection issues or other well-justified reasons.

Do not duplicate information in the Research Plan form and the PHS Human Subjects and Clinical Trials Information form. In your research plan, discuss the overall strategy, methodology, and analyses of your proposed research.

Use the PHS Human Subjects and Clinical Trials Information form to provide detailed information for human subjects studies and clinical trials.

We will review and approve exceptions in accordance with 45 CFR part 46 and, as applicable, 21 CFR part 50 and 21 CFR part 56 and Public Health Service Act (PHSA) section 301(d) (42 USC 241(d)), or we may place a restriction on the award. a restriction on the award.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 24 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.ecfr.gov/current/title-45/part-46 https://www.ecfr.gov/current/title-21/part-50 https://www.ecfr.gov/current/title-21/part-56 https://www.govinfo.gov/content/pkg/USCODE-2022-title42/html/USCODE-2022-title42-chap6A-subchapII-partA-sec241.htm

For more information, please consult the scientific and research contact listed for this NOFO.

Statutory authority Awards are made under the authorization of Section 301 (a) [42 U.S.C. 241(a)] of the Public Health Service Act, and section 391 (a) [42 U.S.C. 280 b(a)] of the Public Service Health Act, as amended.

Step 1: Review the Opportunity 25

Step 2:

Get Ready to Apply

In this step

Get registered 27

Get registered While you can review the requirements and get started on developing your application before your registrations are complete, you must be registered in both SAM.gov and Grants.gov to apply.

SAM.gov You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI). SAM.gov registration can take several weeks. Begin that process today.

To register, go to SAM.gov Entity Registration and select Get Started. From the same page, you can also select the Entity Registration Checklist for the information you will need to register.

Grants.gov You must also have an active account with Grants.gov. You can see step-by step instructions at the Grants.gov Quick Start Guide for Applicants.

Need help? See Contacts and Support.

eRA Commons You must register in eRA Commons. Your senior and key personnel must also register and affiliate their accounts with your organization’s account.

Register at least 4 weeks before the application deadline.

Find the application package The application package has all the forms you need…