Foa_Content_of_RFA-CE-24-011.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL

Grants to Support New Investigators in Conducting Research Related to Understanding Drug Use and Overdose Risk and Protective Factors (K01)

RFA-CE-24-011

12/01/2023

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

Grants to Support New Investigators in Conducting Research Related to Understanding Drug Use and Overdose Risk and Protective Factors (K01) Activity Code

K01 - Mentored Research Scientist Development Award

Notice of Funding Opportunity Type

Reissue of RFA-CE-23-002 Agency Notice of Funding Opportunity Number

RFA-CE-24-011

Assistance Listings Number(s)

93.136 Category of Funding Activity

HL - Health NOFO Purpose

The purpose of the Centers for Disease Control and Prevention National Center for Injury Prevention and Control (NCIPC) Mentored Research Scientist Development Award (K01) is to provide support for an intensive, supervised/mentored career development experience in substance use and/or overdose prevention research leading to research independence. NCIPC supports K01 grants to help ensure the availability of an adequate number of trained scientists to address critical public health research questions to prevent polydrug use and overdose. This funding would support research that aims to better understand and identify risk and protective factors related to any drug use/overdose (e.g., opioids including fentanyl and stimulants, etc.), substance use disorders (SUDs), and stigma (e.g., how do certain factors impact stigma).

Research can focus on the examination of potential moderators or mediators between the relationship between risk and protective factors and drug use and outcomes. Research should be conducted among persons experiencing a disproportionate burden of substance use disorders and overdose, which may include but are not limited, to those people in certain sociodemographic groups (e.g. non-English speaking populations, tribal populations, rural communities, racial/ethnic minority groups, sexual and gender minority groups), people experiencing social determinants of health (e.g., reduced economic stability; limited educational attainment, access or quality; limited healthcare access or quality including those who have been historically underserved or are uninsured; limited access to substance use treatment; limited health literacy;

those in geographically underserved areas), people experiencing social or physical health conditions or experiences (e.g., homelessness, a mental health condition, chronic pain, incarceration or recent release from incarceration, a disability, adverse childhood experiences, a history of suicidal ideation or suicide attempt, a history of substance use disorders and/or overdose).

Key Dates

Publication Date:

To receive notification of any changes to RFA-CE-24-011, 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:

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

11/1/2023

Letters of Intent are requested by 11/01/2023. Although a letter of intent is not required, is not binding, and does not enter into the review of an application, the information that it contains assists NCIPC with planning for scientific and technical merit peer review.

Application Due Date:

12/01/2023 12/01/2023

Please carefully review and follow the instructions in Section IV. Application and Submission Information 9. Submission Dates and Times in order to ensure timely receipt of your application by the application due date at 11:59 PM EST.

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 https://www.grants.gov/ 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 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:

03/05/2024 This is an estimated date.

Secondary Review:

05/01/2024 This is an estimated date.

Estimated Start Date:

09/30/2024 The estimated start date is September 30, 2024.

Expiration Date:

03/08/2024 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.

http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov https://grants.nih.gov/grants/how-to-apply-application-guide.html

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

Executive Summary

Purpose

The purpose of the Centers for Disease Control and Prevention National Center for Injury Prevention and Control (NCIPC) Mentored Research Scientist Development Award (K01) is to provide support for an intensive, supervised/mentored career development experience in substance use and/or overdose prevention research leading to research independence. NCIPC supports K01 grants to help ensure the availability of an adequate number of trained scientists to address critical public health research questions to prevent polydrug use and overdose. This funding would support research that aims to better understand and identify risk and protective factors related to any drug use/overdose (e.g., opioids including fentanyl and stimulants, etc.), substance use disorders (SUDs), and stigma (e.g., how do certain factors impact stigma).

Research can focus on the examination of potential moderators or mediators between the relationship between risk and protective factors and drug use and outcomes.

Research should be conducted among persons experiencing a disproportionate burden of substance use disorders and overdose, which may include but are not limited, to those people in certain sociodemographic groups (e.g. non-English speaking populations, tribal populations, rural communities, racial/ethnic minority groups, sexual and gender minority groups), people experiencing social determinants of health (e.g., reduced economic stability; limited educational attainment, access or quality; limited healthcare access or quality including those who have been historically underserved or are uninsured; limited access to substance use treatment; limited health literacy; those in geographically underserved areas), people experiencing certain social or physical health conditions or experiences (e.g., homelessness, a mental health condition, chronic pain, incarceration or recent release from incarceration, a disability, adverse childhood experiences, a history of suicidal ideation or suicide attempt, a history of substance use disorders and/or overdose).

Applicants should propose to address one or more of the key research questions related to NCIPC’s research priority to identify risk and protective factors for drug overdose listed below:

1. How do risk and protective factors and trajectories for use, misuse, substance use disorder, and/or overdose differ for prescription opioids, illicit opioids, and other emerging drug threats such as resurging methamphetamine and cocaine?

2. What are risk and protective factors and trajectories related to polydrug use and overdose, including co-use of opioid and non-opioid drugs, with a focus on methamphetamine, cocaine, and benzodiazepines?

3. How do these risk and protective factors and trajectories vary by sociodemographic and geographic characteristics at all levels of the social ecology (described in the Background section of this NOFO)?

4. How do risk and protective factors and trajectories related to drug use, misuse, substance use disorders, and overdose vary among populations experiencing a disproportionate burden of substance use disorders and overdose and intersectional social identities?

5. What are risk and protective factors for early drug use initiation (i.e., particularly during youth and adolescence as described in the Background section of this NOFO) and https://www.cdc.gov/injury/researchpriorities/index.html escalation of use? How do these vary among populations experiencing a disproportionate burden of substance use disorders and overdose?

6. What are the associations among adverse childhood experiences (ACEs), prescription opioid misuse and/or illicit drug use, and chronic pain, as well as moderators of these associations, including social determinants of health?

7. What are norms and behaviors surrounding prescription opioid misuse, illicit drug use, overdose, and related health and behavioral outcomes? What are norms and behaviors among people experiencing a disproportionate burden of substance use disorders and overdose and/or groups that are at greater risk of experiencing adverse outcomes related to substance use due to social determinants of health? What are the best strategies to tailor communication about risk such that messages related to these outcomes resonate with all members of the public, particularly those disproportionately affected by overdose?

In developing cross-sectional or longitudinal analyses that correspond to aspects of these research questions, applicants are encouraged to examine mechanisms (e.g., mediation, moderation, applicability of theoretical frameworks), particularly questions that incorporate social determinants of health.

Mechanism of Support: The funding mechanism for this Notice of Funding Opportunity (NOFO) will be a K01 Mentored Research Scientist Development Award.

Funds Available and Anticipated Number of Awards: NCIPC intends to commit up to $450,000 (direct and indirect costs) in FY2024 to support up to three (3) applications for this NOFO. The total funding and the number of awards is contingent upon availability of funds and a sufficient number of meritorious applications.

Budget and Project Period: The maximum award amount will be $150,000 per award for the first 12-month budget period. This includes both direct and indirect costs. For this award, the indirect costs are limited to 8% of Modified Total Direct Cost. Applicants may request a project period of up to three (3) years. The maximum total project funding is $450,000 (direct and indirect) per award, over the project period. The project period is expected to be 09/30/2024 to 09/29/2027. The total award will depend upon the project quality, duration, and cost proposed.

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: Individuals with the skills, knowledge, and resources necessary to carry out the proposed research as the contact PD/PI are invited to work with their institution/organization and mentor to develop an application for support. NOTE: CDC does not make awards to individuals directly.

The purpose of the NCIPC Mentored Research Scientist Development Award (K01) is to provide support for an intensive, supervised/mentored career development experience in substance use and/or overdose prevention research leading to research independence. NCIPC supports K01 grants to help ensure the availability of an adequate number of trained scientists to address critical public health research questions to prevent polydrug use and overdose:

Applicant contact PD/PIs must have a qualifying (relevant to the field of study) research or health- professional doctoral or medical degree (such as PhD, ScD, DO, DrPH, MD, DVM, PharmD, DDS, DMD, PsyD, DPT), from an accredited institution of higher learning. Applications that do not demonstrate that the contact PD/PI has a qualifying (relevant to the field of study) research or health professional doctoral or medical degree (such as PhD, ScD, DO, DrPH, MD, DVM, PharmD, DDS, DMD, PsyD, DPT) from an accredited institution of higher learning, as evidenced by their SF-424 Biographical Sketch, will be considered nonresponsive and will not be forwarded for peer review.

At the time of the NOFO application due date, applicant contact PD/PIs must have less than five years of post-graduate research experience as a researcher in the substance use and overdose prevention field, as documented on the contact PD/PI’s SF-424 Biographical Sketch. The 5-year period will be calculated from the completion of the qualifying degree (e.g., a research or health-professional doctoral or medical degree [such as PhD, ScD, DO, DrPH, MD, DVM, PharmD, DDS, DMD, PsyD, DPT] from an accredited institution of higher learning). The Positions and Employment section of SF- 424 Biographical Sketch is expected to clearly document all of the contact PD/PI’s relevant research experience. Applications that do not demonstrate that the contact PD/PI has less than five years of post-graduate experience as a researcher in the substance use and overdose prevention field, as evidenced by their SF-424 Biographical Sketch, will be considered nonresponsive to the NOFO and will not be forwarded for peer review.

Time periods for significant breaks in employment or employment in areas unrelated to substance use and overdose prevention should be clearly documented. Only the years where any substance use and overdose prevention research was conducted after the completion of the qualifying degree will count towards the limit of five years of research experience. Research conducted during undergraduate or pre-graduate training does not count towards the five-year research time - even if the applicant contact PD/PI authored or co-authored a paper relevant to the research prior to completion of the qualifying degree.

This funding opportunity may support individuals who propose to train in a new field or individuals who have had a hiatus in their research career due to circumstances such as, but not limited to, illness or pressing family circumstances. Applicant contact PD/PIs who are changing their career trajectory to the substance use and overdose prevention field must clearly document the start date of their post-graduate emphasis in substance use and overdose prevention in their SF-424 Biographical Sketch and must clearly demonstrate that they have less than five years of post-graduate experience as a researcher in the substance use and overdose prevention field. Applications from contact PD/PIs who completed their qualifying degree prior to February 09, 2018 and do not clearly document their relevant post-graduate research experience in substance use and overdose prevention (including breaks in employment or research in other areas) will be considered nonresponsive to the NOFO and will not be forwarded for peer review.

Individuals who are identified as the contact PD/PI on a current and/or former CDC or National Institutes of Health (NIH) grant or cooperative agreement award from any of the following excluded independent research assistance mechanisms defined below, as documented by their eRA Commons PD/PI Grant History profile, are NOT eligible for funding under this NOFO. The excluded assistance mechanisms are: CDC or NIH research project (R01 or U01), program project (P01), center grant (R49, P50), sub-project of program project (P01), sub-project of center grant (R49, P50), or other major individual career development award (e.g., K01, K07, K08, K22, K23, K25, K76, K99/R00). Applications with a contact PD/PI eRA Commons Grant History profile that reflects a current or former award in any of the named excluded independent research assistance mechanisms will be considered nonresponsive and will not be forwarded for peer review.

Individuals with current or former funding on the following CDC or NIH training award assistance mechanisms ARE eligible to apply as contact PD/PIs to this NOFO: CDC or NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36 or R49), SBIR/STTR (R41, R42, R43, or R44), Transition Scholar (K38) awards, National Research Service Awards (F30, F31, F32) and individuals appointed to institutional K (K12, KL2) and T (T32) programs.

At the time of award, the contact PD/PI must be a citizen, a non-citizen national of the United States, or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

At the time of the NOFO application due date, the contact PD/PI must have a full-time position at the eligible applicant institution. The application must include a Candidate Eligibility Statement (e.g., an institutional letter of attestation) that is signed by the eligible applicant institution’s Authorized Representative that explicitly verifies the contact PD/PI’s full time employment status. This should be included in the Institutional Commitment to Candidate’s Research Career Development section of the application.

The contact PD/PI is not required to have a tenure track appointment at the eligible applicant institution in order to be eligible for this NOFO. Applications that do not include a Candidate Eligibility Statement that: (1) explicitly verifies the contact PD/PI’s full time employment status and (2) is signed by the applicant institution’s Authorized Representative will be considered nonresponsive and will not be forwarded for peer review.

Applicant contact PD/PIs are required to commit a minimum of 60% of full-time professional effort (i.e., a minimum of 7.3 person-months/year) to their research project and career development for the entirety of the project period. The budget, budget justification, and PHS 308 Career Development Award sections of the application must clearly describe the contact PD/PI’s commitment. Applications that do not demonstrate contact PD/PI commitment to a minimum of 60% of full-time professional effort to their research project and career development for the entirety of the project period, as evidenced by the application’s SF-424 Research and Related Budget effort of at least 7.3 person-months/year for the contact PD/PI, will be considered nonresponsive and will not be forwarded for peer review.

Number of PDs/PIs: There can be only one PD/PI listed in the SF-424 Senior/Key Personnel project role category. Additional Senior/Key Personnel project roles are limited to Mentor, Co- Investigator, Consultant and Other. Multiple PD/PI (i.e., M-PD/PI) and Co-Principal Investigators (Co-PD/PI) project roles are not allowed for this announcement.

Number of Applications: Eligible applicant organizations/institutions may submit more than one application, provided that each application is scientifically distinct. However, applicant institutions can submit only one grant application with the same contact PD/PI in response to this NOFO. Additionally, applicant institutions can submit only one grant application with the same individual designated in a Mentor project role in the application in response to this NOFO. Only one application per contact PD/PI will be reviewed or funded under this announcement; only one application per Mentor will be reviewed or funded under this announcement. If two or more applications from the same contact PD/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 (http://www.grants.gov). If two or more applications identifying the same Mentor 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 (http://www.grants.gov). Applicant institutions submitting applications with essentially the same proposed research to two or more CDC/ATSDR NOFOs will not be funded under more than one NOFO. Contact PD/PIs submitting applications to this NOFO and any other CDC/ATSDR NOFO will not be funded under more than one NOFO.

Special Date(s) A pre-application teleconference call will be conducted on October 10, 2023 to address questions from prospective applicants regarding NOFO RFA-CE-24-011. The call will begin at 2:00pm Eastern Standard Time (EST) and end at 3:00pm 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.

Participant Access Information:

Call Date: October 10, 2023 Call Start Time: 2:00pm Eastern Standard Time (EST) Call End Time: 3:00pm Eastern Standard Time (EST) Call Leader: Joyce Dieterly, MPH, Scientific Program Official Toll-Free Number: 1-866-600-6035 Use Passcode 23198543# when prompted

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

Background Risk and protective factors for drug use, initiation, escalation, and overdose exist at multiple levels of the social ecology. At the individual-level, factors associated with risk span physical and mental health, and biological domains and include early initiation of drug use during youth and adolescence; experiencing pain and a number of mental health conditions; sex and race/ethnicity; and adverse childhood experiences.1-9 Factors associated with some level of protection include such things as employment, affiliation with a religion and frequency of prayer, strong moral beliefs and values including cultural values of respect, and generally concepts of positive youth development.10-14 Some relationship-level factors that increase risk for drug use include a family history of substance use disorder and associating with peers who engage in drug use.15, 16 Some relationship-level factors shown to protect against drug use are parental and peer attitudes and norms that are disapproving of drug use, positive family relationships, more parental monitoring and greater parental involvment.16-20 At the community-level, the environment in which individuals live can impact their level of risk for drug use. For instance, lack of social cohesion, poverty, poor access to healthcare and treatment services, stigma within the community about seeking treatment for substance use disorder, and access to licit and illicit drugs within the community serve as factors that increase risk for drug use.21 Factors associated with some level of protection include strength of adolescents’ school bonds, or involvement and commitment to school, and engagement in prosocial activities at school and in the community.19,22,23 At the societal-level, risk factors for drug use may include poor economic conditions and an/or expansive illicit drug supply while programs such as Prescription Drug Monitoring Programs (PDMPs) that track prescribing practices and patterns and policies limiting access to prescription drugs and enhancing access to substance use disorder treatment options and the life-saving opioid-reversing drug naloxone can serve as factors that protect against drug initiation, use, and overdose.24-29 Research on protective factors at the societal-level has been limited; however, several laws and policies have been implemented to decrease alcohol use (e.g., alcohol taxes, drunk driving laws, minimum legal drinking age).30,31 Importantly, risk may be either attenuated or exacerbated at each level of the social ecology based on various sociodemographic and geographic characteristics, including race/ethnicity, age, socioeconomic status, and rural, suburban, and urban community characteristics.

While prior research has documented these risk and protective factors spanning the social ecology, our understanding of the risk and protective factors for drug overdose is confounded by the complex and evolving nature of the drug overdose epidemic.32 Changes in the illicit drug supply, mixing of drugs with or without the knowledge of the person using those drugs, and polydrug use are factors that contribute to the complexity of the drug overdose landscape and challenge our ability to identify and address risk and protective factors for drug use and overdose.33,34 These factors also create challenges for developing and implementing response and intervention strategies.

Purpose

The purpose of the Centers for Disease Control and Prevention National Center for Injury Prevention and Control (NCIPC) Mentored Research Scientist Development Award (K01) is to provide support for an intensive, supervised/mentored career development experience in substance use and/or overdose prevention research leading to research independence. NCIPC supports K01 grants to help ensure the availability of an adequate number of trained scientists to address critical public health research questions to prevent drug use and overdose, substance use disorders (SUD), and stigma.

This funding would support up to 3 recipients for up to 3 years at up to $150,000 per year to conduct research that aims to better understand and identify risk and protective factors related to any drug use/overdose (e.g., opioids including fentanyl and stimulants, etc.), SUDs, and stigma (e.g., how do certain factors impact stigma). Research can focus on the examination of potential moderators or mediators between the relationship between risk and protective factors and drug use and outcomes. Research should be conducted among persons experiencing a disproportionate burden of substance use disorders and overdose, which may include but are not limited, to those people in certain sociodemographic groups (e.g. non-English speaking populations, tribal populations, rural communities, racial/ethnic minority groups, sexual and gender minority groups), people experiencing social determinants of health (e.g., reduced economic stability;

limited educational attainment, access or quality; limited healthcare access or quality including those who have been historically underserved or are uninsured; limited access to substance use treatment; limited health literacy; those in geographically underserved areas), people experiencing certain social or physical health conditions or experiences (e.g., homelessness, a mental health condition, chronic pain, incarceration or recent release from incarceration, a disability, adverse childhood experiences, a history of suicidal ideation or suicide attempt, a history of substance use disorders and/or overdose).

Applicants should propose a research project that addresses at least one aspect of one key research question related to NCIPC’s priority to identify risk and protective factors for drug overdose included in NCIPC’s Overdose Prevention Research Priorities and listed below.

Key research questions include:

1. How do risk and protective factors and trajectories for use, misuse, substance use disorders, and/or overdose differ for prescription opioids, illicit opioids, and other emerging drug threats such as resurging methamphetamine and cocaine?

2. What are risk and protective factors and trajectories related to polydrug use and overdose, including co-use of opioid and non-opioid drugs, with a focus on methamphetamine, cocaine, and benzodiazepines?

3. How do these risk and protective factors and trajectories vary by sociodemographic and geographic characteristics at all levels of the social ecology (described in the Background section of this NOFO)?

4. How do risk and protective factors and trajectories related to drug use, misuse, substance use disorders, and overdose vary among populations experiencing a disproportionate burden of substance use disorders and overdose and intersectional social identities?

5. What are risk and protective factors for early drug use initiation (i.e., particularly during youth and adolescence as described in the Background section of this NOFO) and burden of substance use disorders and overdose?

6. What are the associations among adverse childhood experiences (ACEs), prescription opioid misuse and/or illicit drug use, and chronic pain, as well as moderators of these associations, including social determinants of health?

7. What are norms and behaviors surrounding prescription opioid misuse, illicit drug use, overdose, and related health and behavioral outcomes? What are norms and behaviors among people experiencing a disproportionate burden of substance use disorders and overdose and/or groups that are at greater risk of experiencing adverse outcomes related to substance use due to social determinants of health? What are the best strategies to tailor communication about risk such that messages related to these outcomes resonate

Each of the key research questions outlined above is broad, multi-faceted, and often intended to highlight multiple gaps in the evidence base. As such, applicants for this NOFO may not anticipate being able to answer an entire key research question with their proposed project.

However, meritorious proposals are expected to provide a thorough plan for addressing at least one aspect of one key research question identified here. For example, not all facets of substance use must be addressed (i.e., use, substance use disorder, overdose) and not all drugs must be studied. Still, applicants should clearly explain how their research will aim to answer one of the research questions above. The funded research projects will help directly address NCIPC’s research priority to:

Identify risk and protective factors for drug overdose, with a focus on overdoses involving opioids, emerging drugs, and polydrug combinations

References

1. Poudel A, Gautam S. Age of onset of substance use and psychosocial problems among individuals with substance use disorders. BMC Psychiatry. 2017;17:10.

2. Schepis TS, Hakes JK. Age of initiation, psychopathology, and other substance use are associated with time to use disorder diagnosis in persons using opioids nonmedically.

Subst Abus. 2017;38(4):407-413.

3. Weiss RD, Potter JS, Griffin ML, et al. Reasons for opioid use among patients with dependence on prescription opioids: the role of chronic pain. J Subst Abuse Treat.

2014;47(20):140-5.

4. Conway KP, Compton W, Stinson FS, et al. Lifetime comorbidity of DSM-IV mood and anxiety disorders and specific drug use disorders: results from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry.

2006;67(2):247-57.

5. Sullivan MD, Edlund MJ, Zhang L, et al. Association between mental health disorders, problem drug use, and regular prescription opioid use. Arch Intern Med.

2006;166(19):2087-93.

https://www.cdc.gov/injury/pdfs/researchpriorities/DOPResearchPriorities_Final_508compliant-002.pdf https://www.cdc.gov/injury/pdfs/researchpriorities/DOPResearchPriorities_Final_508compliant-002.pdf

6. Turk DC, Swanson KS, Gatchel RJ. Predicting opioid misuse by chronic pain patients: a systematic review and literature synthesis. Clin J. Pain. 2008;24(6):497-508.

7. Morley KI, Ferris JA, Winstock AR, et al. Polysubstance use and misuse or abuse of prescription opioid analgesics: a multi-level analysis of international data. Pain.

2017;158(6):1138-44.

8. Swendsen J, Le Moal M. Individual vulnerability to addiction. Ann NY Acad Sci.

2011;1216(1):73-85.

9. Merrick MT, Ford DC, Haegerich TM, et al. Adverse Childhood Experiences Increase Risk for Prescription Opioid Misuse. J Prim Prev. 2020 Apr;41(2):139-152.

10. Bachman JG, Freedman-Doan P, O’Malley PM, et al. Changing patterns of drug use among US military recruits before and after enlistment. Am J Public Health. 1999 May;89(5):672-7.

11. Resnick MD, Bearman PS, Blum RW, et al. Protecting adolescents from harm: findings from the National Longitudinal Study on Adolescent Health. JAMA. 1997 10;278(10):823-32.

12. Scales PC, Leffert N. Developmental assets. Minneapolis, MN: Search Institute; 1999.

13. Oman RF, Vesely S, Aspy CB, et al. The potential protective effect of youth assets on adolescent alcohol and drug use. AJPH. 2004 Aug;94(8):1425-30.

14. Spooner C, Hall W, Lynskey M. Structural determinants of youth drug use. ANCD

Research Paper No. 2. Canberra: Australian National Council on Drugs; 2001.

15. Pickens RW, Preston KL, Miles DR, et al. Family history influence on drug abuse severity and treatment outcome. Drug Alcohol Depend. 2001;61(3):261-70.

16. Walters GD. Prosocial peers as risk, protective, and promotive factors for the prevention of delinquency and drug use. J Youth Adolesc. 2020;49(3):618-30.

17. Morojele NK, Brook JS. Adolescent precursors of intensity of marijuana and other illicit drug use among adult initiators. J Genet Psychol. 2001;162:430-450.

18. White HR, McMorris BJ, Catalano RF, et al. Increases in alcohol and marijuana use during the transition out of high school into emerging adulthood: The effects of leaving home, going to college, and high school protective factors. J Stud Alcohol.

2006;67(6):810-22.

19. Ford JA. Nonmedical prescription drug use among adolescents: The influence of bonds to family and school. Youth & Society. 2009 Mar;40(3):336-52.

20. Resnick MD, Bearman PS, Blum RW, et al. Protecting adolescents from harm: findings from the National Longitudinal Study on Adolescent Health. JAMA.

1997;10;278(10):823-32.

21. Substance Abuse and Mental Health Services Administration. Preventing prescription drug misuse. Overview of factors and strategies; 2016.

22. Voelkl KE, Frone MR. Predictors of substance use at school among high school students.

J Educational Psychol. 2000;92(3):583.

23. King KA, Vidourek RA, Merianos AL. Sex and grade level differences in lifetime nonmedical prescription drug use among youth. J Prim Prev. 2013;34:237-49.

24. Rhodes T, Lilly R, Fernandez C, et al. Risk factors associated with drug use: the importance of ‘risk environment.’ Drugs: education, prevention, and policy.

2003;10(4):303-329.

25. Haffajee RL, Jena AB, Weiner SG. Mandatory use of prescription drug monitoring programs. JAMA. 2015:313(9):891-2.

26. McClellan C, Lambdin BH, Ali MM, et al. Opioid-overdose laws association with opioid use and overdose mortality. Addict Behav. 2018:86:90-5.

27. Gertner AK, Domino ME, Davis CS. Do naloxone access laws increase outpatient naloxone prescriptions? Evidence from Medicaid. Drug Alcohol Depend. 2018:190:37- 41.

28. Strickler GK, Zhang K, Halpin JF, et al. Effects of mandatory prescription drug monitoring program (PDMP) use laws on prescriber registration and use and on risky prescribing. Drug Alcohol Depend. 2019;199:1-9.

29. Sharp A, Jones A, Sherwood J, et al. Impact of Medicaid expansion on access to opioid analgesic medications and medication-assisted treatment. Am J Public Health.

2018;108(5):642-8.

30. Voas RB, Tippetts AS, Fell JC. Assessing the effectiveness of minimum legal drinking age and zero tolerance laws in the United States. Accident Analysis and Prevention.

2003;35:579-587.

31. Elder RW, Lawrence B, Ferguson A, et al. Task Force on Community Preventive Services. The effectiveness of tax policy interventions for reducing excessive alcohol consumption and related harms. Am J Prev Med. 2010;38(2):217-29.

32. O’Donnell J, Gladden RM, Mattson C, et al. Vital Signs: Characteristics of drug overdose deaths involving opioids and stimulants — 24 states and the District of Columbia, January–June 2019. MMWR. 2020;69(35);1189–1197.

33. Drug Enforcement Administration. National Drug Threat Assessment, 2019.

34. Jones C, Olsen E, O'Donnell J, et al. Resurgent Methamphetamine Use at Treatment

Admission in the United States, 2008-2017. Am J Public Health. 2020;110(4):509-516.

Healthy People 2030 and other National Strategic Priorities This research addresses the Healthy People 2030 focus areas of Substance Use and Injury Prevention as described in: https://health.gov/healthypeople. Specifically, this NOFO supports the Healthy People Substance Use (SU) areas of SU-03 Reduce drug overdose deaths, SU-07 Reduce the proportion of adults reporting use of any illicit drugs during the past 30 days, and 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. Additionally, this research addresses the Healthy People health equity related goal of SU-01: Increase the proportion of people with a substance use disorder who got treatment in the past year.

Public Health Impact Expanding the pool of public health researchers in the field of substance use and overdose prevention will increase opportunities for developing innovative and impactful solutions for overdose prevention. New investigators will contribute to our knowledge about the best ways to prevent and address drug use/overdose, SUD, and stigma, particularly with respect to populations who may be at increased risk of drug use initiation or overdose.

Relevant Work

For 30 years, NCIPC has been the nation’s leading public health authority on violence and injury prevention. Preventing drug overdose, including opioid overdose, in the United States requires a comprehensive public health approach. To this end, CDC’s efforts focus on the following areas:

Conducting surveillance and research to monitor emerging trends, identify risk factors, and inform prevention activities;

Strengthening state, local, territorial, and tribal capacity to improve data collection and implement evidence-based prevention strategies;

Working with providers, health systems, and payers to support safer and more effective opioid prescribing and pain management;

Coordinating with public safety and community-based partners to rapidly identify and respond to overdose threats; and

Increasing public awareness about the risks of opioids and other drug overdoses and related harms and reduce stigma.

CDC’s largest investment – Overdose Data to Action (OD2A) – supports funded jurisdictions in collecting high quality, comprehensive, and timely data on nonfatal and fatal overdoses and in using those data to inform prevention and response efforts. OD2A focuses on understanding and tracking the complex and changing nature of the drug overdose epidemic and highlights the need for seamless integration of data into prevention strategies. CDC launched the multiyear OD2A cooperative agreement in September 2019 with 66 recipients (referred to as jurisdictions) comprising state, territorial, county, and city health departments.

In 2023, CDC built on this program with two new funding opportunities, one designed for states (Overdose Data to Action in States) and one designed specifically 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 at all levels of government. Both awards support 5-year cooperative agreements to expand and strengthen overdose surveillance and prevention efforts to reduce fatal and non-fatal overdoses involving opioids and/or stimulants and polysubstance use.

https://www.cdc.gov/drugoverdose/od2a/funding-announcements.html.

In partnership with the Office of National Drug Control Policy (ONDCP), CDC supports more than 700 community coalitions across the country to prevent and reduce substance use among youth through its Drug-Free Communities Support Program (https://www.cdc.gov/drugoverdose/drug-free-communities/about.html).

2. Approach

One of NCIPC's overall goals is to increase the number and diversity of experienced substance use and overdose prevention research professionals available to conduct independent substance use and overdose prevention research. The purpose of this research grant program is to support the development of new researchers who have not yet served as a contact PD/PI on a specified major CDC or NIH research award and address NCIPC’s overdose prevention research priorities specifically related to understanding risk and protective factors associated with drug use and overdose, SUD, and stigma.

Contact PD/PI Requirements https://www.cdc.gov/drugoverdose/prevention/index.html https://www.cdc.gov/drugoverdose/od2a/index.html https://www.cdc.gov/drugoverdose/od2a/funding-announcements.html https://www.cdc.gov/drugoverdose/drug-free-communities/about.html

Individuals who have a qualifying degree, less than five years of experience as a post-graduate researcher in the substance use and overdose prevention field, full time employment at the applicant organization at the time of the NOFO application due date and have not received current or former funding as contact PD/PI on the specified excluded research project mechanisms are eligible to apply. Excluded CDC or NIH research project award mechanisms are: (R01 or U01), program project (P01), center grant (R49, P50), sub- project of program project (P01), sub-project of center grant (R49, P50), or other major individual career development award (e.g., K01, K07, K08, K22, K23, K25, K76, K99/R00).

Applicant contact PD/PIs who have no prior CDC or NIH funding or who have current or former CDC or NIH funding from the following assistance mechanisms are eligible to apply to this NOFO: CDC or NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36 or R49), SBIR/STTR (R41, R42, R43, or R44), Transition Scholar (K38) awards, National Research Service Awards (F30, F31, F32) and individuals appointed to institutional K (K12, KL2) and T (T32) programs.

The contact PD/PI must meet all of the following criteria (see the Executive Summary, Eligible Project Directors/Principal Investigators (PDs/PIs) section for details):

Applicant contact PD/PIs must have a qualifying (relevant to the field of study) research or health- professional doctoral or medical degree (such as PhD, ScD, DO, DrPH, MD, DVM, PharmD, DDS, DMD, PsyD, DPT), from an accredited institution of higher learning. Applications that do not demonstrate that the contact PD/PI has a qualifying (relevant to the field of study) research or health professional doctoral or medical degree (such as PhD, ScD, DO, DrPH, MD, DVM, PharmD, DDS, DMD, PsyD, DPT) from an accredited institution of higher learning, as evidenced by their SF-424 Biographical Sketch, will be considered nonresponsive and will not be forwarded for peer review.

At the time of the NOFO application due date, applicant contact PD/PIs must have less than five years of post-graduate research experience as a researcher in the substance use and overdose prevention field, as documented on the contact PD/PI’s SF-424 Biographical Sketch. The 5-year period will be calculated from the completion of the qualifying degree (e.g., a research or health-professional doctoral or medical degree [such as PhD, ScD, DO, DrPH, MD, DVM, PharmD, DDS, DMD, PsyD, DPT] from an accredited institution of higher learning). The Positions and Employment section of SF- 424 Biographical Sketch is expected to clearly document all of the contact PD/PI’s relevant research experience. Applications that do not demonstrate that the contact PD/PI has less than five years of post-graduate experience as a researcher in the substance use and overdose prevention field, as evidenced by their SF-424 Biographical Sketch, will be considered nonresponsive to the NOFO and will not be forwarded for peer review.

Time periods for significant breaks in employment or employment in areas unrelated to substance use and overdose prevention should be clearly documented. Only the years where any substance use and overdose prevention research was conducted after the completion of the qualifying degree will count towards the limit of five years of research experience. Research conducted during undergraduate or pre-graduate training does not count towards the five-year research time – even if the applicant contact PD/PI authored or co-authored a paper relevant to the research prior to completion of the qualifying degree.

This funding opportunity may support individuals who propose to train in a new field or individuals who have had a hiatus in their research career due to circumstances such as, but not limited to, illness or pressing family circumstances. Applicant contact PD/PIs who are changing their career trajectory to the substance use and overdose prevention field must clearly document the start date of their post-graduate emphasis in substance use and overdose prevention in their SF-424 Biographical Sketch and must clearly demonstrate that they have less than five years of post-graduate experience as a researcher in the substance use and overdose prevention field. Applications from contact PD/PIs who completed their qualifying degree prior to February 09, 2018 and do not clearly document their relevant post-graduate research experience in substance use and overdose prevention (including breaks in employment or research in other areas) will be considered nonresponsive to the NOFO and will not be forwarded for peer review.

Individuals who are identified as the contact PD/PI on a current and/or former CDC or National Institutes of Health (NIH) grant or cooperative agreement award from any of the following excluded independent research assistance mechanisms defined below, as documented by their eRA Commons PD/PI Grant History profile, are NOT eligible for funding under this NOFO. The excluded assistance mechanisms are: CDC or NIH research project (R01 or U01), program project (P01), center grant (R49, P50), sub-project of program project (P01), sub-project of center grant (R49, P50), or other major individual career development award (e.g., K01, K07, K08, K22, K23, K25, K76, K99/R00). Applications with a contact PD/PI eRA Commons Grant History profile that reflects a current or former award in any of the named excluded independent research assistance mechanisms will be considered nonresponsive and will not be forwarded for peer review.

Individuals with current or former funding on the following CDC or NIH training award assistance mechanisms ARE eligible to apply as contact PD/PIs to this NOFO: CDC or NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36 or R49), SBIR/STTR (R41, R42, R43, or R44), Transition Scholar (K38) awards, National Research Service Awards (F30, F31, F32) and individuals appointed to institutional K (K12, KL2) and T (T32) programs.

At the time of award, the contact PD/PI must be a citizen, a non-citizen national of the United States, or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

At the time of the NOFO application due date, the contact PD/PI must have a full-time position at the eligible applicant institution. The application must include a Candidate Eligibility Statement (e.g., an institutional letter of attestation) that is signed by the eligible applicant institution’s Authorized Representative that explicitly verifies the contact PD/PI’s full time employment status. This should be included in the Institutional Commitment to Candidate’s Research Career Development section of the application.

The contact PD/PI is not required to have a tenure track appointment at the eligible applicant institution in order to be eligible for this NOFO. Applications that do not include a Candidate Eligibility Statement that: (1) explicitly verifies the contact

PD/PI’s full time employment status and (2) is signed by the applicant institution’s Authorized Representative will be considered nonresponsive and will not be forwarded for peer review.

Applicant contact PD/PIs are required to commit…