HEAL Initiative: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K01 - Clinical Trial Required)

HEAL Initiative: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K01 - Clinical Trial Required) is sponsored by National Institutes of Health (NIH). This program supports early career investigators with foundational training in substance use prevention or treatment research to acquire expertise and conduct research in implementation science.

It requires the development and execution of an independent NIH-defined clinical trial applying implementation science methods to one of the four domains of the HHS Overdose Prevention Strategy: prevention, evidence-based addiction treatment, harm reduction, or recovery research.

Expired PAS-22-206: HEAL Initiative: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K01 - Clinical Trial Required) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Drug Abuse ( NIDA ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Mental Health ( NIMH ) National Center for Complementary and Integrative Health ( NCCIH ) National Cancer Institute ( NCI ) Funding Opportunity Title HEAL Initiative: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K01 - Clinical Trial Required) K01 Research Scientist Development Award - Research & Training Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Mentored Patient-Oriented Research Devel Awd See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) 93.

279, 93. 273, 93. 398, 93.

242, 93. 213 Funding Opportunity Purpose The purpose of this Mentored Research Scientist Development Award in Implementation Science for Substance Use Prevention and Treatment (K01) is to provide support and protected time (3-5 years) for an intensive, supervised career development experience leading to research independence in this area of specialization.

Realizing the return on public investment in the development of evidence-based treatments and preventive interventions to address the ongoing overdose crisis depends on a cadre of skilled researchers with expertise in implementation science, who can help move these interventions into routine practice.

Implementation science focuses on identifying modifiable barriers to the uptake and sustained use of evidence-based practices in real world settings and developing replicable and scalable strategies to overcome those barriers.

While this field has grown rapidly over the past 15 years, there remain a limited number of independent researchers with dual expertise in addiction research and implementation science, constraining the field’s capacity to respond to continued calls for research in this area.

There is a pressing need for a deeper bench of researchers who can be called upon to meet ongoing and emerging implementation challenges in the addiction field. This Funding Opportunity Announcement (FOA) will support early career investigators who have foundational training in substance use prevention or treatment research and will provide support and protected time to acquire training and research experience in implementation science.

Development and execution of an independent NIH-defined clinical trial applying implementation science methods to one of the four domains of the HHS Overdose Prevention Strategy (prevention; evidence-based addiction treatment; harm reduction; or recovery research) is required. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization. Applications are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Career Development (K) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) 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. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description The overall goal of the NIH Research Career Development program is to help ensure that a pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs.

NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals.

More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the NIH Mentored Research Scientist Development Award (K01) is to provide salary and research support for a sustained period of protected time (3-5 years) for intensive research career development, under the guidance of an experienced mentor, or sponsor in the biomedical, behavioral or clinical sciences leading to research independence.

The expectation is that, through this sustained period of research career development and training, recipients will launch independent research careers and become competitive for new research project grant (e.g., R01) funding. This Funding Opportunity Announcement (FOA) is part of the NIH Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis.

The NIH HEAL Initiative bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://heal. nih.

gov/ . Successfully addressing the ongoing overdose epidemic requires a cadre of skilled researchers who can move existing and emerging evidence-based treatment and prevention practices into routine use. The discipline best positioned to develop scalable, sustainable strategies to move research findings into practice is implementation science .

This FOA invites career development applications proposing research projects that will identify, develop, test, evaluate, and/or refine strategies to disseminate and implement interventions and services aligned with the HHS Overdose Prevention Strategy (i.e., prevention; evidence-based addiction treatment; harm reduction; and/or recovery support services).

Applicants may also focus on strategies to promote the de-implementation of outdated, ineffective, or harmful practices in these domains. Addressing the overdose crisis also requires recognition that patients may have a complex array of clinical and social needs.

As such, this FOA is also open to researchers with an interest in integrating evidence-based prevention and treatment services for opioids and common co-occurring conditions, including alcohol misuse/alcohol use disorder, mental illness, and/or HIV. All applications should be within the scope of the mission of at least one of the participating Institutes/Centers.

Applicants should focus on testing implementation strategies to improve the quality, effectiveness, availability, and affordability of substance use prevention or treatment services; and to promote their integration and accessibility across a variety of settings (e.g., specialty care, primary care, schools, workplaces, and other nontraditional healthcare and community settings).

Examples of research projects that fall within the scope of this FOA include, but are not limited to: Studies of implementation strategies to integrate effective prevention or treatment practices into existing care systems.

These practices may include (but are not limited to) health promotion, prevention, screening, early detection, and diagnostic interventions, as well as evidence-based treatments, clinical procedures, or practice guidelines. Studies of the implementation of multiple evidence-based practices within community or clinical settings to meet the needs of complex patients with co-occurring conditions across various systems of care.

Studies of the local adaptation of evidence-based practices in the context of implementation. Longitudinal and follow-up studies on the factors that contribute to the sustainability of evidence-based interventions in public health and clinical practice.

Studies on reducing or stopping ("de-implementing") the use of clinical and community practices to prevent and address opioid misuse/opioid use disorder that are ineffective, unproven, low-value, or harmful.

Studies of the relationship of context and local capacity of clinical and community settings to adoption, implementation, and sustainability of evidence-based prevention and treatment interventions, harm reduction, or recovery support services.

Studies of strategies to impact organizational structure, climate, culture, and processes to enable implementation of effective clinical/public health interventions to prevent and address opioid misuse/opioid use disorder and co-occurring conditions. NIMH is particularly interested in applications that focus on implementation science for the prevention and treatment of co-occurring substance use and mental illness.

For example, through the HEAL Initiative, NIMH leads a portfolio of research to help improve the provision of services for people with co-occurring opioid use disorder and mental disorders and/or suicide risk. It is strongly recommended that NIMH mentored K01 applicants review the following guidance, which includes following NIMH's experimental therapeutics approach to intervention development: https://www. nimh.

nih. gov/funding/training/career-development-programs-k-series#12 In developing research projects, applicants are strongly encouraged to address issues of patient/stakeholder engagement; scalability beyond the study sites/settings; sustainability beyond the funding period; and whether the proposed implementation strategy/process reduces disparities in service availability, access, utilization, cost, quality, or outcomes.

Clinical Trial Required: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development.

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." Most implementation trials including those that randomize at the organization, system or community level meet this definition.

For additional details and frequently asked questions, visit https://grants. nih. gov/policy/clinical-trials/definition.

htm Applicants should clearly justify the duration of requested support, taking into consideration prior research experience and the proposed mentored career development goals that are essential for developing an independent, NIH-funded research program at the intersection of substance use and implementation science. Projects may not exceed 5 years.

Applications should include a clear plan for career development activities that will support the candidate’s transition to research independence, including milestones, and evidence of significant institutional commitment to the continued development of the K01 candidate as an independent researcher at the applicant institution.

Applicants are expected to plan to apply for independent research support during the later years of their mentored career award. Pre-Application Consultation: Potential applicants are strongly encouraged to consult with NIH Program staff early in the application development process.

This early contact will provide an opportunity to discuss and clarify NIH policies and guidelines, including the scope of the project relative to the HEAL initiative mission and intent of this FOA. See Scientific/Research Contacts in Section VII of this FOA. PI Meeting Attendance: The NIH HEAL Initiative will require a high level of coordination and sharing between investigators.

It is expected that NIH HEAL Initiative grant recipients will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.

Data Harmonization for Substance Abuse, Addiction, and Mental Disorders via the PhenX Toolkit: Applicants involved in human-subjects studies are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection and the Mental Health Collection of the PhenX Toolkit ( www.

phenxtoolkit. org ). Please see NOT-DA-12-008 ( http://grants.

nih. gov/grants/guide/notice-files/NOT-DA-12-008. html ) for further details.

NIMH Common Data Elements: NIMH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.

NIH has established a "Common Data Element (CDE) Resource Portal" ( http://cde. nih. gov/ ) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.

The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth regarding existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community.

Please see https://nida. nih. gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/points-to-consider-regarding-tobacco-industry-funding-nida-applicants Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations. Section II.

Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Required: Only accepting applications that propose an independent clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIH intends to commit approximately $1. 1 million total in FY2023, spread across PAS-22-206 and PAS-22-207 .

Up to 6 total awards across these two FOAs are anticipated. Similar commitments are expected for FY2024, contingent upon availability of funds and receipt of a sufficient number of meritorious applications. Award budgets are composed of salary and other program-related expenses, as described below.

The total project period must be a minimum of 3 but no more than 5 years. Other Award Budget Information Applicants may request salary support up to $90,000 plus fringe benefits per year, consistent with their institution’s salary scale. A minimum of 9 person months (75% effort) must be devoted to the career award.

Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094 . In addition, the candidate may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate (see http://grants.

nih. gov/grants/policy/salcap_summary. html ) and the total percent effort does not exceed 100%.

See also NOT-OD-17-094 . Other Program-Related Expenses NIH will contribute $50,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

These funds may be used for the following expenses: (a) tuition and fees related to career development; (b) research-related expenses, such as supplies, equipment, technical personnel, and participant incentives; (c) travel to research meetings or training; and (d) statistical services including personnel and computer time.

Applicants are expected to allocate funds from the Research Support budget to attend the annual HEAL Investigators Meeting, where, in addition to attending conference sessions, K01 awardees will participate in informal mentoring, networking, and grantsmanship activities facilitated by NIH program staff. Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks. All PD(s)/PI(s) must be registered with ORCID .

The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

Eligible Individuals (Program Director/Principal Investigator) Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and organization to develop an application for support. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or 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). The aggregate total of NIH mentored career award support (both institutional [e.g., KL2, K12] and individual) cannot exceed 6 years.

For NIMH applicants, eligibility for the K01 is limited to individuals with no more than 6 years of postdoctoral experience at the time of application (either the initial or resubmission application). Candidates for the K01 award must have a research or health-professional doctoral degree.

Candidates must demonstrate via biosketch (degree, training, work experience), publications, and/or reference letters foundational training or experience in substance use prevention or treatment. At the time of award, the applicant must have secured a full-time faculty or faculty equivalent appointment in an appropriate research-intensive environment.

Current and former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), Project Leads of program project (P01), or center grants (P50), other major individual career development awards (e.g., K01, K07, K08, K22, K23, K25, K76, K99/R00), or the equivalent are not eligible.

Current and former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grants (R21/R33), Planning Grant (R34/U34), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible, as do PD/PIs of Transition Scholar (K38) awards and individuals appointed to institutional K programs (K12, KL2). Candidates for the K01 award must have a research or health-professional doctoral degree.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per 2. 3. 7.

4 Submission of Resubmission Application . An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review. (See 2.

3. 9. 4 Similar, Essentially Identical, or Identical Applications ).

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application.

K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065 . At the time of award, the candidate must have a full-time appointment at the academic institution.

Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.

See NOT-OD-18-156 and NIH Grants Policy Statement , Section 12. 3. 6.

4 Temporary Adjustments to the Percent Effort Requirement for more details. Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience.

The mentor should be an active investigator with demonstrated expertise in implementation science and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research.

Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application.

The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. The mentor(s) or mentoring team must demonstrate appropriate expertise in substance use and implementation science, and the experience and ability to guide the applicant in the organization, management and execution of the proposed research and clinical trial.

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

Institutional Environment The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research. Section IV. Application and Submission Information 1.

Requesting an Application Package Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Career Development (K) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications . All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. Include a description of your current research and the research you propose to continue in the independent phase.

SF424(R&R) Senior/Key Person Profile Expanded All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Career Development Award Supplemental Form Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections: Other Candidate Information Mentor, Co-Mentor, Consultant, Collaborators Environment & Institutional Commitment to the Candidate Other Research Plan Sections All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Candidate Information and Goals for Career Development Candidate’s Background Describe the candidate's commitment to a health-related research career.

Describe all the candidate's professional responsibilities in the recipient institution and elsewhere and describe their relationship to the proposed activities on the career award. Describe prior training and how it relates to the objectives and long-term career plans of the candidate. Describe the candidate's research efforts to this point in his/her research career, including any publications, prior research interests and experience.

Provide evidence of the candidate's potential to develop into an independent investigator. If applicable, describe the candidate's ability to organize, manage, and implement the proposed clinical trial, feasibility or ancillary clinical trial. If applicable, describe the candidate's prior efforts, interests and experience in clinical trials research.

Career Goals and Objectives? Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) that justifies the need for further career development to become an independent investigator.

The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

Candidate’s Plan for Career Development/Training Activities During Award Period The candidate and the mentor(s) are jointly responsible for the preparation of the career development plan. A career