RFA-CE-25-028_20240830.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL

Effectiveness Research to Prevent Polysubstance-Impaired Driving

RFA-CE-25-028

12/02/2024

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

Overview

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

National Center for Injury Prevention and Control Notice of Funding Opportunity (NOFO) Title Effectiveness Research to Prevent Polysubstance-Impaired Driving Activity Code Applications for this Notice of Funding Opportunity (NOFO) will be funded using the U01 activity code for a research cooperative agreement.

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-CE-25-028

Assistance Listings Number(s) 93.136 Category of Funding Activity HL - Health NOFO Purpose The Centers for Disease Control and Prevention’s (CDC) National Center for Injury Prevention and Control (NCIPC) is soliciting investigator-initiated research to rigorously evaluate and examine effectiveness of strategies, programs, or policies (collectively referred to as “strategies”) for preventing polysubstance-impaired driving and associated crashes, nonfatal injuries, or deaths. Polysubstance-impaired driving means driving while impaired by two or more substances, such as alcohol and opioids or cannabis and alcohol. Comprehensive evaluations of strategies to prevent polysubstance-impaired driving are lacking and urgently needed given the changing landscape of substance use and impaired driving. Additionally, given inequitable impacts on some populations (American Indian and Alaska Native [AIAN] communities, rural populations, etc.), research is needed to examine strategy effectiveness among different populations. This NOFO supports research that can help fill these gaps.

Research may include, but is not limited to, evaluation of the impact of any of the following on preventing polysubstance-impaired driving and related outcomes:

• Evidence-based alcohol-impaired driving strategies that may also prevent polysubstance-impaired driving. Examples include, but are not limited to, screening and brief intervention and alternative transportation or transit programs.

• Strategies that prevent excessive alcohol use, harmful substance use, or substance use disorders that have the capacity to also prevent polysubstance-impaired driving.

Examples include, but are not limited to, taxation or pricing policies for alcohol and cannabis, social norming campaigns, and multi-component coalition-based strategies (e.g., Drug Free Communities Programs or similar efforts).

This NOFO encourages examination of strategy effects on polysubstance-impaired driving and associated injuries and deaths among the overall population and disproportionately affected populations.

Key Dates Publication Date:

To receive notification of any changes to RFA-CE-25-028, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

An email address is needed for this service.

Letter of Intent Due Date:

11/01/2024

While a letter of intent is not mandatory, nor is it binding or a factor in the review of an application, the details it provides help NCIPC staff to plan for the scientific and technical merit peer review process.

Application Due Date:

12/02/2024

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 11:59 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 https://www.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:

03/18/2025 This date is an estimate.

Secondary Review:

04/22/2025 This date is an estimate.

Estimated Start Date:

09/30/2025 Expiration Date:

02/01/2025 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - 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 12 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 This NOFO will support research to rigorously evaluate and examine effectiveness of strategies for preventing polysubstance-impaired driving and associated crashes, nonfatal injuries, or http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov https://grants.nih.gov/grants/how-to-apply-application-guide.html deaths. Polysubstance-impaired driving means driving while impaired by two or more substances, such as alcohol and opioids or cannabis or alcohol.

Mechanism of Support

The funding mechanism for this NOFO will be a research cooperative agreement (U01).

Funds Available and Anticipated Number of Awards

CDC/NCIPC intends to commit up to $350,000 in FY 2025 to fund one (1) application. Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications.

Budget and Period of Performance

The estimated total funding (direct and indirect) for the first budget period, 9/30/2025 to 9/29/2026, is $350,000. The estimated total funding (direct and indirect) for the entire Period of Performance, 9/30/2025 to 9/29/2028, is $1,050,000.

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. Eligibility Information 1. Eligible Applicants are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs)

CDC does not award individuals directly. Individuals possessing the necessary skills, knowledge, and resources to conduct proposed research should collaborate with their institutions to submit a support application. Underrepresented racial and ethnic groups, as well as individuals with disabilities, are especially encouraged to apply.

For applications where the contact PD/PI qualifies as an NIH Early Stage Investigator (ESI), as confirmed through the NIH Investigator Status determination process, and has a commendable peer review score, prioritization may occur during the second level of review (refer to Section V.

Application Review Information 4. Review and Selection Process).

Regarding the determination of Investigator Status for the contact PD/PI: Before submitting an application, PD/PIs should confirm or update the date of their terminal research degree or the https://grants.nih.gov/policy/early-stage/index.htm conclusion of their post-graduate clinical training in their eRA Commons Profile for accurate identification. NIH systems will automatically determine each investigator's status and reflect it in their eRA Commons personal profile. The ESI status for PD/PIs on any R01 or equivalent application will be indicated at submission. Investigators must ensure their status is accurately represented in their profile. If the status is incorrect, they should reach out to the NIH eRA Service Desk.

Number of PDs/PIs

An application may name more than one PD/PI; their names must appear on the face page of the application. However:

• One (1) principal investigator must be designated as the contact PD/PI for all correspondence related to the application.

• All PD/PIs must include their eRA Commons Identification in the Credential Field of the Senior/Key Person Profile Component of the SF-424 (R&R) Application Package.

• Institutions/organizations proposing multiple PDs/PIs must visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF-424 (R&R) Application Guide.

Number of Applications

Organizations eligible to apply may submit multiple applications to this NOFO, as long as each is scientifically distinct. However, institutions may only submit one application per contact PD/PI. Only one application for each contact PD/PI will receive funding under this announcement. If multiple applications from the same contact PD/PI are submitted, only the most recent one, based on the time and date stamp at www.grants.gov, will be considered for review. It is the applicant's responsibility to withdraw any duplicate applications before the review date.

Institutions that submit applications proposing essentially the same research to two or more CDC NOFOs will not receive funding for more than one.

Application Type

NEW

Special Date(s)

A pre-application webinar call will be conducted on October 16, 2024 to address questions from prospective applicants regarding NOFO RFA-CE-25-028. The call will begin at 2:00pm Eastern Standard Time (EST) and end at 2:50pm Eastern Standard Time (EST), or sooner if all questions are addressed. Questions and answers from the discussion will be included in an amended NOFO approximately 3 weeks after the call.

https://grants.nih.gov/support/index.html https://grants.nih.gov/support/index.html

Participant Access Information

• Call Date: October 16, 2024

• Call Start Time: 2:00pm Eastern Standard Time (EST)

• Call End Time: 2:50pm Eastern Standard Time (EST)

• Call Leader: Emiko Petrosky, MD, MPH, Scientific Program Official

• Webinar Link:

https://cdc.zoomgov.com/j/1619698650?pwd=bkZRcU9ZQmhSbksxWnZqaVl3VVNaQ T09

• Webinar ID: 161 969 8650

• Passcode: 9+s5.!b?

• Call-In Numbers:

o +1 669 254 5252 US (San Jose) o +1 646 828 7666 US (New York) o +1 646 964 1167 US (US Spanish Line) o +1 415 449 4000 US (US Spanish Line) o +1 551 285 1373 US (New Jersey) o +1 669 216 1590 US (San Jose)

• Dial-In Passcode: 12693189

Application Materials

See Section IV.1 for application materials.

Hearing Impaired

Telecommunications for the hearing impaired are available at: TTY: 1-888-232-6348.

Section I. Funding Opportunity Description Statutory Authority 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 Health Service Act, as amended.

1. Background and Purpose Substance use and polysubstance use are prevalent behaviors in the United States that are associated with numerous public health problems and harms. According to the 2022 National Survey on Drug Use and Health, approximately 137 million people reported alcohol use; 42 million people reported marijuana (hereafter referred to as cannabis) use; 41 million people reported any prescription tranquilizer or sedative use; and 74 million people reported any opioid use in the month prior to the survey. Among people who drank alcohol in the past month, 11% combined cannabis and alcohol the last time they drank [1]. Recent surveillance also indicates https://cdc.zoomgov.com/j/1619698650?pwd=bkZRcU9ZQmhSbksxWnZqaVl3VVNaQT09 https://cdc.zoomgov.com/j/1619698650?pwd=bkZRcU9ZQmhSbksxWnZqaVl3VVNaQT09 that more than 80% of individuals reporting opioid misuse also reported misuse of other drugs, and among those who used heroin, 36% used methamphetamine [2].

A notable harm associated with substance use and polysubstance use is transportation-related crashes and associated nonfatal and fatal injury. Alcohol and other drugs have impairing effects on the skills needed for safe driving [3,4], and the prevalence of substance- and polysubstance-related impairment while driving is substantial. In 2022, 23 million people aged 21 years and older self-reported driving under the influence of alcohol or illegal drugs in the year prior to the survey, with 11 million reporting driving under the influence of cannabis and 2 million reporting driving under the influence of other illegal drugs including cocaine, heroin, hallucinogens, inhalants, or methamphetamine [1]. In addition to self-report data, several recent reports have examined drug presence among drivers in biological samples [5-7]. In a recent National Transportation Safety Board (NTSB) report on drivers arrested for impaired driving who were tested at the Orange County, California Laboratory from August 2018 to July 2020, 28% of drivers arrested for impaired driving were positive for both alcohol and one other potentially impairing substance (e.g., cannabis, stimulants, inhalants). More drivers were positive for alcohol and cannabis (14%) than cannabis only (5%) [6]. Moreover, a recent National Highway Traffic Safety Administration (NHTSA) report examined data from September 2019 to July 2021 of drivers killed in crashes and found that of the 555 fatally injured drivers, 12% were positive for alcohol and cannabis [7].

Alcohol-impaired driving-related crashes are consistently associated with one third of traffic crashes (i.e., crashes occurring on public trafficways, like roads or highways). In 2022, more than 13,000 lives were lost in impaired driving-related crashes [8]. Previous research demonstrates that driving while polysubstance-impaired is a road safety and public health issue of particular concern [1,3,4,6,7, 8], given evidence demonstrating the effects of drugs on driving performance [3,4], the high prevalence of self-reported driving under the influence of drugs, and evidence of combined alcohol and drug positivity in the driving population. Additionally, several evolving safety concerns underscore the need for urgent understanding and implementation of effective strategies to prevent polysubstance-impaired driving. These safety concerns include the decrease in perceived risks of cannabis use and continuing high levels of opioid use and overdose [9-12]. Comprehensive evaluations of strategies to prevent polysubstance-impaired driving are lacking.

Given CDC’s emphasis on primary prevention, the purpose of this NOFO is to further research on upstream strategies that can prevent polysubstance-impaired driving. Potential strategies of interest could include:

• Evidence-based strategies previously employed to prevent alcohol-impaired driving, including screening and brief intervention and alternative transportation or transit programs [13]. Primary prevention strategies proven effective for preventing alcohol-impaired driving might or might not also be effective at preventing polysubstance-impaired driving [13].

• Strategies that prevent excessive alcohol use, harmful drug/substance use, or substance use disorders that may also prevent polysubstance-impaired driving. Examples include, but are not limited to, taxation or pricing policies on alcohol and/or cannabis, social norming campaigns, and multi-component coalition-based strategies (e.g., Drug Free Communities Programs or similar efforts). Given the complexity of the polysubstance use landscape and the multitude of efforts focused on reducing excessive alcohol use, harmful drug/substance use, or substance use disorders, understanding the extent to which these evidence-based strategies for substance use outcomes also reduce crashes and related nonfatal and fatal transportation injury outcomes is warranted.

Equity considerations are critical when implementing and evaluating any public health approach, including impaired driving-related strategies. Some populations have higher risk for crashes and deaths involving impaired driving. For example, AIAN individuals have the highest alcohol-impaired driving death rates among all racial and ethnic groups in the United States, and rural populations have higher alcohol-impaired driving death rates than urban populations [14-15].

This NOFO encourages examination of strategy effects on overall populations and populations disproportionately affected by crashes and related injuries and deaths.

Purpose See detailed NOFO Purpose section.

References

1. Substance Abuse and Mental Health Services Administration. 2022 NSDUH Detailed Tables, Center for Behavioral Health Statistics and Quality; Nov 2023. Available at:

https://www.samhsa.gov/data/report/2022-nsduh-detailed-tables.

2. Bobashev GV, Warren LK. National polydrug use patterns among people who misuse prescription opioids and people who use heroin. Results from the National Household Survey on Drug Use and Health. Drug and Alcohol Dependence. 2022;238(1). doi:

10.1016/j.drugalcdep.2022.109553

3. Hartman RL, Huestis MA. Cannabis effects on driving skills. Clin Chem.

2013;59(3):478–492. doi:10.1373/clinchem.2012.194381

4. Hels T, Lyckegaard A, Simonsen KW, Steentoft A, Bernhoft IM. Risk of severe driver injury by driving with psychoactive substances. Acc Analysis & Prev. 2013;59:346-56.

5. Berning A, Smith RC, Drexler M, Wochinger K. Drug testing and traffic safety: What you need to know (Report No. DOT HS 813 264)). Washington, DC: U.S. Department of Transportation, National Highway Traffic Safety Administration (NHTSA); 2022.

Available at: https://rosap.ntl.bts.gov/view/dot/60969

6. National Transportation Safety Board. Alcohol, other drug, and multiple drug use among drivers (ntsb.gov), Safety Research Report SRR-22-02, National Transportation Safety Board: Washington, DC; 2022.

7. Thomas FD, Darrah J, Graham L, Berning A, Blomberg R, Finstad K, Griggs C, Crandall M, Schulman C, Kozar R, Lai J, Mohr N, Chenoweth J, Cunningham K, Babu K, Dorfman J, Van Heukelom J, Ehsani J, Fell J, Whitehill J, Brown T, Moore C. Alcohol and drug prevalence among seriously or fatally injured road users (Report No. DOT HS 813 399). Washington, DC: U.S. Department of Transportation, National Highway Traffic Safety Administration (NHTSA), Office of Behavioral Safety Research; 2022.

8. National Center for Statistics and Analysis. Alcohol-impaired driving: 2022 data (Traffic Safety Facts. Report No. DOT HS 813578), National Highway Traffic Safety https://www.samhsa.gov/data/report/2022-nsduh-detailed-tables https://www.sciencedirect.com/science/article/pii/S0376871622002903?via%3Dihub https://www.sciencedirect.com/science/article/pii/S0376871622002903?via%3Dihub https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3836260/ https://www.sciencedirect.com/science/article/abs/pii/S0001457513002315?via%3Dihub https://www.sciencedirect.com/science/article/abs/pii/S0001457513002315?via%3Dihub https://rosap.ntl.bts.gov/view/dot/60969 https://www.ntsb.gov/safety/safety-studies/Documents/SRR2202.pdf https://www.ntsb.gov/safety/safety-studies/Documents/SRR2202.pdf https://www.ntsb.gov/safety/safety-studies/Documents/SRR2202.pdf https://www.nhtsa.gov/sites/nhtsa.gov/files/2022-12/Alcohol-Drug-Prevalence-Among-Road-Users-Report_112922-tag.pdf https://www.nhtsa.gov/sites/nhtsa.gov/files/2022-12/Alcohol-Drug-Prevalence-Among-Road-Users-Report_112922-tag.pdf https://www.nhtsa.gov/sites/nhtsa.gov/files/2022-12/Alcohol-Drug-Prevalence-Among-Road-Users-Report_112922-tag.pdf

Administration: Washington, DC; 2024. Available at:

https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/813578

9. Insurance Institute for Highway Safety. Marijuana laws. Insurance Institute for Highway Safety, Highway Loss Data Institute; 2024. https://www.iihs.org/topics/alcohol-and-drugs/marijuana-laws-table

10. Terry-McElrath YM, O'Malley PM, Patrick ME, Miech RA. Risk is still relevant: Time-varying associations between perceived risk and marijuana use among US 12th grade students from 1991 to 2016. Addictive Behaviors 2017;74:13-19.

11. Han BH, Funk-White M, Ko R, Al-Rousan T, Palamar JJ. Decreasing perceived risk associated with regular cannabis use among older adults in the United States from 2015 to 2019. Journal of the American Geriatrics Society 2021;69(9):2591-7.

12. Kariisa M, Davis NL, Kumar S, Seth P, Mattson CL, Chowdhury F, Jones CM. Vital Signs: Drug Overdose Deaths, by Selected Sociodemographic and Social Determinants of Health Characteristics — 25 States and the District of Columbia, 2019–2020. MMWR 2022;71(29):940-7.

13. Kirley BB, Robison KL, Goodwin AH, Harmon KJ, O Brien NP, West A, Harrell SS, Thomas L, Brookshire K. Countermeasures that work: A highway safety countermeasure guide for state highway safety offices, 11th Edition, National Highway Traffic Safety Administration. Wa Report No. DOT HS 813 490; 2023.

14. National Highway Traffic Safety Administration. Fatality and Injury Reporting System Tool (FIRST). Washington, DC: U.S. Department of Transportation, National Highway Traffic Safety Administration, National Center for Statistics and Analysis. Available at https://cdan.dot.gov/query. Accessed July 2024.

15. National Highway Traffic Safety Administration (NHTSA). Rural/urban comparison of motor vehicle traffic fatalities (Traffic Safety Facts. Report No. DOT HS 813488).

Washington, DC: U.S. Department of Transportation, National Highway Traffic Safety Administration, National Center for Statistics and Analysis; 2024.

Healthy People 2030 and other National Strategic Priorities The proposed research aligns with NCIPC’s approach to injury prevention, described in:

https://www.cdc.gov/injury-violence-prevention/programs/research-priorities.html?CDC_AAref_Val=https://www.cdc.gov/injury/researchpriorities/index.html. This research supports the specific motor vehicle injury prevention research priorities, described in:

https://www.cdc.gov/injury/pdfs/researchpriorities/NCIPC_Research- Priorities_Transportation_Safe.pdf.

This research addresses the Healthy People 2030 focus areas of injury and violence prevention as described in: https://health.gov/healthypeople. Specifically, this NOFO supports the Healthy People 2030 Injury and Violence Prevention (IVP) areas of:

• IVP-1 Reduce fatal injuries

• IVP-2 Reduce emergency department visits for nonfatal injuries

• IVP-3 Reduce unintentional injury deaths

• IVP-4 Reduce emergency department visits for nonfatal unintentional injuries

• IVP-6 Reduce deaths from motor vehicle crashes

• SU-11 Reduce the proportion of motor vehicle crash deaths that involve a drunk driver https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/813578 https://www.iihs.org/topics/alcohol-and-drugs/marijuana-laws-table https://www.iihs.org/topics/alcohol-and-drugs/marijuana-laws-table https://www.sciencedirect.com/science/article/pii/S030646031730206X https://www.sciencedirect.com/science/article/pii/S030646031730206X https://www.sciencedirect.com/science/article/pii/S030646031730206X https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.17213 https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.17213 https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.17213 https://www.cdc.gov/mmwr/volumes/71/wr/mm7129e2.htm https://www.cdc.gov/mmwr/volumes/71/wr/mm7129e2.htm https://www.cdc.gov/mmwr/volumes/71/wr/mm7129e2.htm https://www.nhtsa.gov/sites/nhtsa.gov/files/2023-12/countermeasures-that-work-11th-2023-tag_0.pdf https://www.nhtsa.gov/sites/nhtsa.gov/files/2023-12/countermeasures-that-work-11th-2023-tag_0.pdf https://www.nhtsa.gov/sites/nhtsa.gov/files/2023-12/countermeasures-that-work-11th-2023-tag_0.pdf https://cdan.dot.gov/query https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/813488 https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/813488 https://www.cdc.gov/injury-violence-prevention/programs/research-priorities.html?CDC_AAref_Val=https://www.cdc.gov/injury/researchpriorities/index.html https://www.cdc.gov/injury-violence-prevention/programs/research-priorities.html?CDC_AAref_Val=https://www.cdc.gov/injury/researchpriorities/index.html https://www.cdc.gov/injury/pdfs/researchpriorities/NCIPC_Research-Priorities_Transportation_Safe.pdf https://www.cdc.gov/injury/pdfs/researchpriorities/NCIPC_Research-Priorities_Transportation_Safe.pdf https://health.gov/healthypeople

Public Health Impact The goal of this funding is to identify strategies most effective at preventing polysubstance-impaired driving and associated deaths and injuries. Increasing our understanding of this public health problem could inform prevention efforts at both the federal and state levels. State departments of health and transportation could use the results of this research to inform the prioritization of safe driving strategies that could reduce polysubstance-impaired driving deaths and injuries. Given the high rates of impaired driving-related crashes among some populations (AIAN individuals, rural populations, etc.), the proposed project could examine potential strategy effects on polysubstance-impaired driving and associated injuries and deaths among disproportionately affected populations as well as aggregate population-level effects.

Relevant Work For more than 30 years, NCIPC has been the nation’s leading public health authority on injury and violence prevention. CDC’s approach involves focusing on data, science, and action to address public health problems and keep people safe, healthy, and productive.

Relevant work conducted by the Injury Center includes:

• Barry V, Schumacher A, Sauber-Schatz E. Alcohol-impaired driving among adults— USA, 2014–2018. Inj Prev. 2022;28(3):211–217. doi:10.1136/injuryprev-2021-044382

• Shults RA, Shaw KM, Yellman MA, Jones SE. Does geographic location matter for transportation risk behaviors among U.S. public high school students?. J Transp Health.

2021;22:101134. doi:10.1016/j.jth.2021.101134

• Jones JM, Shults RA, Robinson B, Komatsu KK, Sauber-Schatz EK. Marijuana and alcohol use among injured drivers evaluated at level I trauma centers in Arizona, 2008– 2014. Drug Alcohol Depend. 2019;204:107539. doi:10.1016/j.drugalcdep.2019.06.041

• Shults RA, Jones JM, Komatsu KK, Sauber-Schatz EK. Alcohol and marijuana use among young injured drivers in Arizona, 2008–2014. Traffic Inj Prev. 2019;20(1):9–14.

doi:10.1080/15389588.2018.1527032

2. Approach For NOFO RFA-CE-25-028, applicants should rigorously evaluate and examine effectiveness of strategies to prevent polysubstance-impaired driving and associated crashes, nonfatal injuries, or deaths. Polysubstance-impaired driving means driving while impaired by two or more substances, such as alcohol and opioids. Applicants should propose rigorous evaluation designs.

Rigorous evaluation designs use experimental (i.e., randomization) and quasi-experimental methods (e.g., matched comparison groups, propensity score matching, instrumental variables, regression point displacement, regression discontinuity, time series). Data analytic plans should be appropriate to the prevention strategy, research design, hypotheses, data collection measures, and period of performance. Investigators should anticipate, evaluate, and address threats to the internal and external validity of the specified research design.

Given challenges with estimating and examining polysubstance-impaired driving-related outcomes (e.g., lack of testing and documentation on some death records), applicants should clearly state and justify how they will obtain valid estimates of polysubstance-impaired driving-related outcomes. Regardless of the design, using multiple data sources is encouraged to improve the validity and reliability of outcomes selected and measured. Examples of potential primary outcome measures and data sources include, but are not limited to:

https://injuryprevention.bmj.com/content/28/3/211.long https://injuryprevention.bmj.com/content/28/3/211.long https://www.sciencedirect.com/science/article/pii/S221414052100164X https://www.sciencedirect.com/science/article/pii/S221414052100164X https://www.sciencedirect.com/science/article/pii/S0376871619302984?via%3Dihub https://www.sciencedirect.com/science/article/pii/S0376871619302984?via%3Dihub https://www.sciencedirect.com/science/article/pii/S0376871619302984?via%3Dihub https://www.tandfonline.com/doi/full/10.1080/15389588.2018.1527032 https://www.tandfonline.com/doi/full/10.1080/15389588.2018.1527032

• Motor vehicle crash data

• Emergency medical services data

• Emergency department records

• Police reports

• Hospital records

• Vital Statistics (death certificate data)

• Roadside testing data

• Self-reported survey data

• Other toxicology or drug test data

Investigators who propose using existing data should:

• Articulate plans for securing data use agreements

• Broadly describe data cleaning and standardization protocols

• Discuss methods for use, evaluation, and validation of results

Applicants should detail the prevention strategy implementation and evaluation design feasibility, including but not limited to, demonstrating expertise with data sources and methods described in the proposal. Details should include access to data and the research team.

Objectives/Outcomes Investigators will conduct effectiveness research to identify strategies that can prevent polysubstance-impaired driving. Polysubstance-impaired driving means driving while impaired by two or more substances. Examples include: alcohol and cannabis; alcohol and opioids (prescription or illegal); cannabis and opioids (prescription or illegal); alcohol and other drugs;

or alcohol and cannabis and opioids (prescription or illegal). Applicants must clearly define and justify how they are measuring polysubstance impairment and fully describe the strategies studied.

Research questions might include:

• What is the impact of innovative strategies on the prevention of polysubstance-impaired driving crashes, injuries, and deaths?

• What is the effectiveness of strategies shown to prevent alcohol-impaired driving to also prevent polysubstance-impaired driving and related crash, injury, and death outcomes?

• Are positive and negative impacts of the strategy constant across groups? What are the health equity implications of any differences?

Secondary questions could also include those on understanding strategy implementation, such as:

• What are barriers and facilitators to polysubstance-impaired driving strategies?

• How can strategy implementation occur on a large scale or in specific populations/locations/settings?

• What are the costs of strategy implementation and any associated cost effectiveness?

Recommended outcomes of interest include motor vehicle crashes associated with polysubstance-impaired driving and resulting injuries and deaths. However, measuring these recommended outcomes of impaired driving is very difficult. Therefore, research may propose outcomes which do not directly measure polysubstance-impaired driving or its consequences as long as the outcomes measured can be sufficiently linked to polysubstance-impaired driving (e.g., self-reported polysubstance-impaired driving behavior). For research proposing an outcome that is not directly measuring polysubstance-impaired driving, motor vehicle crash, injury or death, applicants should clearly describe how the outcomes are sufficiently linked to polysubstance-impaired driving or outcomes. Data for outcome measurement may include, but are not limited to crash records, emergency department records, roadside substance testing, toxicology data, or self-report survey data. Applicants are encouraged to examine strategy effectiveness in at least one disproportionately affected population (race, ethnicity, rurality, etc.).

It is critical that the selection of a disproportionately affected population is made using high quality, accessible and up-to-date data, with a defensible rationale to show how the group selected meets criteria related to high burden and/or rates of morbidity and mortality.

Population of Focus This research should focus on users of public roads affected by polysubstance-impaired driving.

This includes, but is not limited to:

• drivers

• passengers

• pedestrians

• bicyclists

• other road users

• Groups who have high risk for impaired driving and related crashes, injuries, and deaths

(AIAN individuals, people living in rural communities, etc.).

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.

Collaboration/Partnerships For all applications, it is anticipated that the applicant organization and the principal investigator (PI) will provide the necessary scientific and technical leadership to carry out the proposed research for the duration of the project. The Research Strategy section of the application, along with the SF-424 Research and Related Budget, should reflect the organization's leadership and engagement for the full period of performance. The applicant organization must not act merely as a "pass through" to fund another entity to conduct most of the research or to provide the essential groups at higher risk for scientific or technical leadership needed to complete the project.

NCIPC acknowledges the significance of community conditions and community-centered research in completing the proposed work. Applicants are highly encouraged to involve communities meaningfully, including state and local health departments, local government agencies, businesses, and community organizations, in research development, conduct, and dissemination of findings. This includes forming robust partnerships with community members who have lived experience to inform the strategy evaluation design.

Collaborations between the applicant institution and external entities may be necessary or beneficial to complete the proposed work. The application must distinctly outline the roles and responsibilities of each partner. This includes proof of the applicant's access to the intended data sources and study populations, as well as all necessary partnerships to carry out the proposed project.

The Research Strategy section should clearly describe the roles and responsibilities of each research team member and participating organization. It should detail how the collaboration will enable the applicant to carry out the proposed work. The section must delineate the nature and scope of the partnership, including the duties of the Principal Investigator(s) and partner entities, the current working relationship, research plans, the level of involvement from both the applicant institution and the partner, the partner's work scope, and how the partnership will facilitate the execution and continuity of the proposed evaluation. Additionally, the Research Strategy must comprehensively outline all data sources and the established partnerships that will ensure data availability for all intended analyses within the period of performance.

Each partnering entity's roles and responsibilities must be validated with a signed Data Sharing Agreement, Letter of Support (LOS), or Memorandum of Understanding (MOU). These documents must detail the partner's commitment to resources, time, and personnel for the proposed research. Applications lacking a signed Data Sharing Agreement, Letter of Support, or Memorandum of Understanding from each partner may not be recommended for funding (refer to Section V. Application Review Information, 4. Review and Selection Process). Applicants are responsible for clearly outlining each partner's contributions to the proposed research in the Research Strategy and confirming each partner's intent and capabilities with a signed agreement.

This NOFO aims for diversity among applicant institutions, research investigators, and partnering organizations to ensure research experiences and outcomes benefit all segments of the population and social ecology. Applicant organizations from or conducting research in collaboration or partnership with institutions that have a demonstrated record of or historical commitment to serving underrepresented students, including racial and ethnic minorities, individuals from disadvantaged backgrounds and individuals with disabilities may be considered during the second level of review (see Section V. Application Review Information, 4. Review and Selection Process). Applicants may indicate this in the Research Strategy of their application.

This NOFO supports the involvement of early-stage investigators on the SF-424 Senior/Key Personnel research team to foster experience and expertise in injury prevention research.

Applications must show that the research team possesses the required skills and experience to guarantee the quality and timely execution of the proposed activities. Involvement of students and emerging researchers is recommended. Those intending to integrate training and mentorship into their research should outline their strategies for recruiting, educating, and overseeing trainees/mentees, as well as ensuring the continuous quality of their scientific outputs.

Evaluation/Performance Measurement Applicants must evaluate and document performance during each stage of the research process.

This could include partnership development, study development, outcome measurement, data collection, and data analysis. The application should clearly describe relevant performance measures for each stage of the research project. Comparison of actual progress to the performance measures should document whether the research is progressing appropriately and in a timely manner. This comparison should also document whether the research activities are of high scientific quality.

Translation Plan The application should clearly describe the potential for widespread dissemination, implementation, and sustainability of the proposed research. Investigators should collaborate with CDC investigators to develop a plan for next steps for the research findings. The plan should describe how dissemination of the results will achieve the greatest impact. Investigators must propose how to translate research findings into actionable recommendations.

Grant recipients may be required to attend one reverse site visit per year in Atlanta with CDC/NCIPC staff during the period of performance 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 the application's travel budget submitted in response to this NOFO.

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:

$1,050,000 Anticipated Number of Awards:

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

Award Ceiling:

$350,000 Per Budget Period

Award Floor:

$0 Per Budget Period

Total Period of Performance Length:

3 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)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

23 (Small businesses)

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification)) https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

99 (Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility")

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of Higher Education)

Other:

Faith-based or Community-based Organizations

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.

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 See Section III. Eligibility Information.

https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true

4. Justification for Less than Maximum Competition N/A

5. Responsiveness Applicants are responsible for ensuring their application complies with all the responsiveness criteria outlined in this section. Applications failing to meet these criteria will be deemed nonresponsive and will not proceed to peer review. The proposed research objectives in the applicant's abstract must align with the objectives of this announcement, as detailed in Section I, "Objectives/Outcomes."

• The proposed budget for each fiscal year must be less than or equal to the budget ceiling of $350,000 as outlined in Section II: Award Information. Applications that exceed the budget in any year will be considered nonresponsive and will not be forwarded for peer review.

• Applicants must include a SF-424 Biographical Sketch for the PI or Co-Investigator(s) that documents expertise in motor vehicle injury prevention, specifically impaired driving. The knowledge, experience, and expertise necessary to conduct this research and achieve proposed objectives must document experience of at least one first-authored, peer-reviewed publication as defined by the NIH National Library of Medicine in the relevant area of motor vehicle injury prevention, specifically impaired driving, OR by serving as a principal investigator on a research grant in motor vehicle injury prevention, specifically impaired driving prevention. Experience requirements may be demonstrated through the combined experiences of a Principal and Co-Principal Investigator (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 non-responsive and will not be forwarded for peer review.

• Applicants must propose to evaluate the effectiveness of a strategy, program, or policy to prevent driving while impaired by two or more substances in the Research Strategy section of the Research Plan. Applications that do not propose to evaluate the effectiveness of a strategy to prevent driving while impaired by two or more substances, as evidenced in the Research Strategy section of the Research Plan, will be considered nonresponsive and will not be forwarded for peer review.

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 Unique Entity Identifier (UEI) number in order to begin each of the following registrations.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission. The UEI replaced the Data Universal Numbering System (DUNS) and 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.

https://www.nlm.nih.gov/nichsr/stats_tutorial/section3/mod6_peer.html 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/

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

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. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process.

During the submission process, ASSIST will prompt the Signing Official…