G.130 - Program Overview

Research and Other ("R" Series)

The purpose of research and other awards is to provide support for health-related research and development based on the mission of the NIH. Some examples of support include pilot studies; conferences and scientific meetings; small research projects; institutional training and director program projects; resource programs; and new, exploratory, and developmental research projects. Awards may be in the form of grants or cooperative agreements.

Before Applying:

1. Become familiar with Activity Code: Applicants should become familiar with the activity code for which support is being requested. These include many "R" activity codes, as well as some "DP," "G," "S," and "U" activity codes. A comprehensive list of all activity codes, with their descriptions, is available on NIH's Research Career Development (K) Awards Kiosk page.
2. Refer to your specific NOFO: Refer to your NOFO for specific information associated with the award mechanism, including the eligibility requirements, review criteria, award provisions, any special application instructions, and names of individuals who may be contacted for additional or clarifying information prior to application submission.
   • NOFOs and other guidelines are available on the NIH research training career development web page.
   • Opportunities for various career award opportunities are issued periodically in the NIH Guide for Grants and Contracts.
   • Some individual K-series programs supported by the NIH include a delayed-award activation and/or two award phases (e.g., K22, K99/R00). NIH intramural researchers may be eligible to apply for these awards. The NOFO will include any additional and/or specific instructions that must be followed when applying for such support.
3. Contact Awarding Component: Applicants are encouraged to consult with the NIH Scientific/Research contact of the appropriate awarding component prior to submitting an application, as eligibility criteria, support levels, and availability of awards may vary among NIH Institutes or Centers and other PHS agencies.

The following chart provides a summary of the existing research programs; however, the chart is not a comprehensive list of activity codes. Since this information is subject to change, prospective applicants are encouraged to review NIH's Types of Grant Programs for the most current program information.

Summary of Research Award Programs*

Activity Code	Program Description
R01	Research Project
R03	NIH Small Grant Program
R13	Conference
R15	Research Enhancement Awards
R21	NIH Exploratory / Developmental Research Grant Award
R25	Education Projects
R41	Small Business Technology Transfer (STTR) Grants - Phase I
R42	Small Business Technology Transfer (STTR) Grants - Phase II
R43	Small Business Innovation Research (SBIR) Grants - Phase I
R44	Small Business Innovation Research (SBIR) Grants - Phase II
U01	Research Project - Cooperative Agreements
U13	Conference - Cooperative Agreements
G07	Resources Improvement Grant
S10	Biomedical Research Support Shared Instrumentation Grants
DP1	NIH Director's Pioneer Award (NDPA)

*This is not a comprehensive list of activity codes.

Individual Research Career Development Award (CDA) Application ("K" Series)

The purpose of the career development award (CDA) program is to provide candidates at the postdoctoral, early career, and mid-career stages with opportunities to build on their initial research training and to further develop their research careers through individual or institutional awards.

This section provides instructions for candidates applying for individual career development awards. Applicants for institutional career development programs, such as the K12 award, should follow the guidance provided in the "Additional Instructions for Training" sections.

Reference Letters: Instructions for submitting the required reference letters for applicable programs are not contained in these application instructions. Instead, follow the instructions on NIH's Reference Letters page. Referees must submit reference letters through the eRA Commons by the application due date.

Before Applying:

1. Become familiar with Activity Code: Applicants should become familiar with the K activity code for which support is being requested. A listing of "K" series activity codes, with their descriptions, is available on the Research Career Development Awards page.
2. Refer to your specific NOFO: Refer to your NOFO for specific information associated with the award mechanism, including the eligibility requirements, requirements for a mentor or mentors, review criteria, award provisions, any special application instructions, and names of individuals who may be contacted for additional or clarifying information prior to application submission.
   • NOFOs and other guidelines are available on the NIH K Kiosk.
   • Opportunities for various career award opportunities are issued periodically in the NIH Guide for Grants and Contracts.
   • Some individual K-series programs supported by the NIH include a delayed-award activation and/or two award phases (e.g., K22, K99/R00). NIH intramural researchers may be eligible to apply for these awards. The NOFO will include any additional and/or specific instructions that must be followed when applying for such support.
3. Contact Awarding Component: Applicants are encouraged to consult with the NIH Scientific/Research contact of the appropriate awarding component prior to submitting an application, as eligibility criteria, support levels, and availability of awards may vary among NIH Institutes or Centers and other PHS agencies.

The following chart provides a summary of the existing individual career development programs. Since this information is subject to change, prospective applicants are encouraged to review the K Kiosk for the most current program information.

Summary of Research Career Development Award Programs

Program	Description	Mentor	Reference Letter
K01	Mentored Research Scientist Career Development Award	Yes	Yes
K02	Independent Research Scientist Development Award	No	No
K05	Senior Research Scientist Award	No	No
K07	Academic Career Development Award	*	*
K08	Mentored Clinical Scientist Research Career Development Award	Yes	Yes
K18	Research Career Enhancement Award for Established Investigators	Yes	Yes
K22	Career Transition Award	*	Yes
K23	Mentored Patient-Oriented Research Career Development Award	Yes	Yes
K24	Mid-Career Investigator Award in Patient-Oriented Research	No	No
K25	Mentored Quantitative Research Career Development Award	Yes	Yes
K26	Mid-Career Investigator Award in Biomedical and Behavioral Research	No	No
K43	Emerging Global Leader Award	Yes	Yes
K76	Emerging Leaders Career Development Award	Yes	Yes
K99/R00	Pathways to Independence Award	Yes	Yes

*Varies with career status and source of award. Check the NOFO.

Organizational Research Training and Career Development Program Applications ("T" Series)

The purpose of research training awards is to provide support for institutional research training programs and opportunities for trainees at the undergraduate, graduate, and postdoctoral levels.

Training-specific instructions apply both to NIH-supported Ruth L. Kirschstein National Research Service Award (NRSA) institutional research training programs (e.g., T32, T34, T35, T36, T90) and to non-NRSA training and career development programs (e.g. T15, T37, D43, D71, K12, U2R).

NRSA Programs: These programs help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to carry out the nation's biomedical and behavioral research agenda. Certain specialized training grants, such as undergraduate training grants (T34), are provided under this authority.

Non-NRSA Programs: Non-NRSA training and career development programs operate under different regulatory authorities than NRSA programs. While much of the information may be the same, individuals interested in those programs should carefully read the applicable Notice of Funding Opportunity (NOFO) for specific program information and special application instructions. Non-NRSA training programs may have eligibility requirements, due dates, award provisions, and review criteria that differ from those of NRSA programs.

Payback Service Requirement: For NRSA programs that include postdoctoral trainees, the program director must explain the terms of the payback service requirement to all prospective postdoctoral training candidates. A complete description of the service payback obligation is available in the NIH Grants Policy Statement, Section 11.4.3: Payback.

Before Applying:

1. Become familiar with Activity Code: Applicants should become familiar with the activity code and the purpose of the specific program for which support is being requested. A listing of "T" series activity codes, with their descriptions, is available on the Organizational Training Grants page.
2. Refer to your specific NOFO: Refer to your NOFO for specific information associated with the award mechanism and the names of individuals who may be contacted for additional or clarifying information prior to application submission.
   • NOFOs and other guidelines are available on the NIH T Kiosk.
   • Opportunities for various training programs are issued periodically in the NIH Guide for Grants and Contracts, a weekly electronic publication, that is available on NIH's Funding page.
3. Contact Awarding Component: Applicants are encouraged to consult with the NIH Scientific/Research contact of the appropriate awarding component prior to submitting an application, as eligibility criteria, support levels, and availability of awards may vary among NIH Institutes or Centers and other PHS agencies.

The following chart provides a summary of the existing training programs. Since this information is subject to change, prospective applicants are encouraged to review the T Kiosk for the most current program information.

Summary of Organizational Training Programs

Activity Code	Program Description	NRSA?
D43	International Research Training Grants	No
D71	International Research Training Planning Grant	No
K12	Clinical Scientist Organizational Career Development Program Award	No
T32	Organizational National Research Service Award (NRSA)	Yes
T34	Undergraduate National Research Service Award (NRSA) Organizational Research Training Grant	Yes
T35	National Research Service Award (NRSA) Short-Term Organizational Research Training Grant	Yes
T36	National Research Service Award (NRSA) Short-Term Organizational Research Training Grant	Yes
T90	Interdisciplinary Research Training Award	Yes
U2R	International Research Training Cooperative Agreement	No

Individual Fellowship Applications ("F" Series)

The purpose of individual fellowship awards is to provide individual research training opportunities to fellows at the graduate and postdoctoral levels. This section contains information for preparing Kirschstein-NRSA (NRSA) fellowship and non-NRSA fellowship applications.

NRSA Programs: The NRSA program helps ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to carry out the nation's biomedical and behavioral research agenda. NRSA fellowships are awarded as a result of national competition for research training in specified health-related areas. Certain specialized individual fellowships, such as the predoctoral fellowships (F31 and F30), postdoctoral fellowships (F32), senior fellowships (F33), and other institute-specific fellowship programs, are provided under this authority.

Non-NRSA Programs: NIH Institutes and Centers also have unique funding authorities for fellowships that are not under the NRSA authority. Note that non-NRSA programs may have eligibility requirements, due dates, award provisions, and review criteria that differ from those of NRSA programs. Applicants should refer to their NOFO.

Reference Letters: Instructions for submitting the required reference letters for applicable programs are not contained in these application instructions. Instead, follow the instructions on NIH's Reference Letters page. Referees must submit reference letters through the eRA Commons by the application due date. eRA Commons credentials are not required to submit reference letters.

Payback Service Requirement: For NRSA programs that include postdoctoral fellows, the program director must explain the terms of the payback service requirement to all prospective postdoctoral fellowship candidates. A complete description of the service payback obligation is available in the NIH Grants Policy Statement, Section 11.4.2: Implementation.

Before Applying:

1. Become familiar with Activity Code: Applicants should become familiar with the "F" activity code for which support is being requested. A listing of "F" series activity codes, with their descriptions, is available on the NIH Individual Fellowships (F) Kiosk and the AHRQ Research Training and Education page.
2. Refer to your specific NOFO: Refer to your specific NOFO for specific information associated with the award mechanism, including the eligibility requirements, requirements for a mentor, review criteria, award provisions, any special application instructions, and names of individuals who may be contacted for additional or clarifying information prior to application submission.
   • NOFOs and other guidelines are available on the NIH Individual Fellowships (F) Kiosk.
   • Guidelines for the AHRQ fellowships may be found on AHRQ's AHRQ Research Training and Education website.
3. Contact Awarding Component: Applicants are encouraged to consult with the appropriate NIH IC or AHRQ staff prior to submitting an application, as not all predoctoral, postdoctoral, and senior fellowships are supported by each IC or AHRQ.
   • A list of contacts specifically for extramural training at the NIH ICs can be found on the NIH Extramural Research Training Representatives page.
   • For contacts at AHRQ, see AHRQ's Research Training Staff Contacts website.

The following chart provides a list of fellowship activity codes. Since this information is subject to change, prospective candidates are encouraged to review the Individual Fellowships (F) Kiosk for the most current program information.

Summary of Individual Fellowship Award Programs

Activity Code	Program Description	NRSA?
F05	International Research Fellowships	No
F30	Individual Predoctoral National Research Service Award (NRSA) for M.D./Ph.D. and Other Dual Degree Fellowships	Yes
F31	Predoctoral Individual National Research Service Award	Yes
F32	Postdoctoral Individual National Research Service Award	Yes
F33	National Research Service Awards for Senior Fellows	Yes
F37	Medical Informatics Fellowships	No
F38	Applied Medical Informatics Fellowships	No
F99/K00	Individual Predoctoral to Postdoctoral Fellow Transition Award	No

Multi-project Applications ("M" Series)

A multi-project application is a single submission with multiple, interrelated components that share a common focus or objective.

A component is a distinct, reviewable part of a multi-project application for which there is a business need to gather detailed information as defined in a particular Notice of Funding Opportunity (NOFO). Components typically include general information (component organization, project period, project title, etc.), information about performance sites, information about proposed work to be accomplished, and a budget.

Although multi-project applications use the same forms used for single-project applications, there are some differences in the way multi-project applications are structured. Every multi-project application includes:

• A Single Overall Component: The Overall Component describes the entire application and provides an overview of how each of the other components fit together.
• One or more Other Component Types: Other Component types (e.g., Admin Core, Project Core) will vary by opportunity and will be specified in the NOFO.
• Summaries: Information is automatically compiled from the data provided by the applicant in the individual components and included as part of the Overall Component in the agency-assembled application to help reviewers and staff work with the application. The following summaries are generated:
• Component
• Performance Sites
• Human Subjects - Clinical Trials - Vertebrate Animals- hESC
• Human Embryonic Stem Cell Lines
• Budget
• Program Income
• Senior/Key Personnel
• Biosketches

For information on how your application will be automatically assembled for review and funding consideration after submission, see the How eRA Assembles Multi-project Applications file.

Before Applying:

1. Become familiar with Activity Code: Applicants should become familiar with the activity code(s) for which support is being requested. A comprehensive list of all activity codes, with their descriptions, is available on the Activity Codes Search Results website.
2. Refer to your specific NOFO: Refer to your specific NOFO for specific information associated with the award mechanism, including special application instructions.
   • The NOFO will specify the types of Other Components that should be used when preparing the application, whether each component is optional or required, and any restrictions on the number of times each component can be included in an application.
3. Contact Awarding Component: Applicants are encouraged to consult with the NIH Scientific/Research contact of the appropriate awarding component prior to submitting an application, as eligibility criteria, support levels, and availability of awards may vary among NIH Institutes or Centers and other PHS agencies.

Collaborating with Other Organizations

Multi-project applications often include a number of collaborating organizations in addition to the applicant organization. The applicant organization always has primary responsibility for and leads the Overall Component. A collaborating organization may be responsible for a small part of a component or have lead responsibility for an entire Other Component within the application.

Depending on the role of the collaborating organization(s) in the project, there are two approaches to structuring a component:

A. Collaborating Organization as the Lead of a Component:

When the bulk of the leadership and work on a component (other than the Overall Component) is performed by a collaborating organization, then that organization can be set up as the lead organization for that component. All the component forms (including the SF 424 R&R Form and the R&R Budget Form) are completed using the collaborating organization's information. On the R&R Budget Form, use the Budget Type "Project" to identify it as the primary budget for the component and provide the collaborating organization's Unique Entity Identifier (UEI) number and name. Any other organizations involved in the component (including the applicant organization) are included in subaward/consortium budget forms.

From an administrative perspective, the entire component (minus any work done by the applicant organization) is treated as a subaward/consortium to the applicant organization. The structure of the application reflects where the proposed work is being done, not the flow of funds. eRA systems use the Unique Entity Identifier (UEI) numbers included on budget forms to determine the flow of funds.

B. Collaborating Organization as a Consortium in a Component:

When a collaborating organization does not have a leadership role for a component, then the applicant organization is the component lead, and any collaborating organizations are included using the subaward/consortium budget form.

Multi-project Application Component Forms

You must complete a set of forms for each component.

The assembled application image created for a multi-project application has a predefined order. For information on multi-project application assembly, see the How eRA Assembles Multi-project Applications file.

The chart below summarizes which forms must be completed for each component.

Component Data Forms

Form	Overall	Admin Core, Core Project, Other named components	Indiv Career Dev	Career Dev	NRSA Training
SF424 R&R cover
PHS 398 Cover Page Supplement
R&R Other Project Information
Project/Performance Sites
R&R Sr/Key Person Profile (Expanded)
PHS Human Subjects and Clinical Trials Information
PHS Assignment Request Form	Optional
R&R Budget
R&R Subaward Budget Attachment		Optional	Optional	Optional
PHS 398 Training Budget
Training Subaward Budget Attachment Form					Optional
PHS Additional Indirect Costs	Optional
PHS 398 Research Plan
PHS 398 Career Development Award Supplemental Form
PHS 398 Research Training Program Plan

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR)

The Small Business Programs, Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR), are known as America's Seed Fund because they provide U. S. small businesses with over $1 billion each year in non-dilutive funding for early-stage healthcare product development. These programs support U.S.-owned and operated small businesses to engage in research and development activities to develop innovative technologies that have a strong potential for commercialization and patient impact. HHS focuses on a wide variety of high-impact technologies including drugs, biologics, medical devices, diagnostics, digital health products, and research tools.

New to SBIR/STTR?

View our SBIR/STTR How to Apply Instructions page.

View the Understanding SBIR / STTR description page.

Confirm Small Business Eligibility Criteria.

Develop an Innovative Research and Development Proposal with Commercial Potential

Determine which SBIR/STTR funding opportunity is most appropriate for your idea. The general Omnibus SBIR/STTR solicitations allow researchers to submit their own ideas to NIH, Center for Disease Control (CDC), and the Food and Drug Administration (FDA).Specific SBIR/STTR Funding Opportunities solicit proposal that address targeted research areas of special interest. Before starting the application process, you should speak with an HHS SBIR/STTR representative, usually referred to as Program Officials, to get feedback on the programmatic fit of your project. If you are unsure of who to contact, you can email SEED (Small business Education and Entrepreneurial Development) at [email protected].

Required Registrations

The registration process may take 6 - 8 weeks, so it is important to start early. Learn about the registration process, including the SBA Company Registration, which is unique to SBIR/STTR applicants. Small businesses are encouraged to submit via ASSIST.

Phased Program:

Both the SBIR and STTR programs are organized in two phases of government funding:

• Phase I: Supporting Feasibility and Proof of Concept; and
• Phase II: Supporting Research and Development.

An expectation of the SBIR and STTR programs is that award recipients will use internal resources, or additional follow-on funding from the private sector, to move the product or service developed through their Phase II award into the marketplace. While not a Phase I or II, The Commercialization Readiness Pilot (CRP) program uses SBIR funding to provide additional support to advance products toward commercialization. CRP applicants must comply with SBIR eligibility requirements and follow all SBIR Phase II application instructions.

The table below summarizes the types of SBIR/STTR applications.

Application Type	Definition	Participating HHS Component	Commercialization Plan Requirement
Phase I	Focuses on the feasibility, technical merit, and commercial potential of the project.	NIH, CDC*, FDA*	No
Fast-Track	Phase I and Phase II submitted and reviewed in one application. The Fast-Track mechanism can minimize the funding gap between phases but requires a fully developed Phase II application/plan at the time of submission.	NIH	Yes
Direct Phase II (SBIR Only)	Small businesses that have already demonstrated scientific and technical merit and feasibility but have not received a Phase I SBIR or STTR for that project can apply for a Direct to Phase II. Small businesses can submit a Direct to Phase II application regardless of the funding source for the proof of principle work on which the proposed Phase II research is based. However, small businesses that are eligible to submit Phase II applications for projects that were supported with a Phase I SBIR or STTR award are required to submit the regular Phase II application.	NIH	Yes
Phase II	Continues the research and development efforts initiated in Phase I. A small business can apply for a Phase II award once the Phase I milestones have been reached, even if that occurs before the end of the Phase I award. Applications for a Phase II award may be submitted up to six receipt dates after the Phase I budget period expires. Only one Phase II award is allowed for each project supported by a Phase I award.	NIH, CDC*, FDA*	Yes
Phase IIB	For projects that require extraordinary time and effort beyond the Phase II to achieve commercialization. . *Must have received a Phase II to apply*	NIH	Yes
Commercialization Readiness (CRP) Pilot Program	Provides Phase II and Phase IIB recipients with technical assistance and/or funding for late stage development. The CRP may fund commercialization activities that are not typically supported through SBIR/STTR Phase II or Phase IIB awards. *Must have Phase II or IIB to apply*	NIH, CDC	Yes

* CDC and FDA participate in SBIR only.

The current budget guidelines for the SBIR and STTR programs can be found in the Omnibus SBIR/STTR solicitations. The budget guidelines are the same for both programs, but individual NIH Institutes and Centers can set their own budget limits and Specific SBIR/STTR Funding Opportunities may have their own budgetary guidance. The NIH recognizes that some biomedical innovations require funding levels above the award guidelines to reach the marketplace. For those topics, the NIH has a waiver from the Small Business Administration (SBA) to allow larger awards. The list of approved topics can be found on the SBIR and STTR Funding Opportunities page. Applicants are strongly encouraged to contact program officials prior to submitting any application in excess of the total award amounts listed in the solicitation. Applicants are strongly encouraged to contact NIH Program Officers prior to submitting any application in excess of the guidelines and early in the application planning process. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project. Not all Institutes or Centers offer Phase IIB or CRP awards and allowable budgets may vary. For a full listing of those Institutes or Centers that accept Phase IIBs or CRPs, see the Omnibus Solicitation program Descriptions and Research Topics document.

Disclosure Requirements Regarding Ties to Foreign Countries

Effective for competing applications submitted on or after September 5, 2023, applicants will be required to disclose all funded and unfunded relationships with foreign countries, using the Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form, (referred to hereafter as the SBIR STTR Foreign Disclosure Form) for all owners and covered individuals.

Upon request, applicants will submit the completed SBIR STTR Foreign Disclosure Form via the Just-In-Time (JIT) process described in the NIH GPS section 2.5.1 Just-in-Time Procedures. The SBIR STTR Foreign Disclosure Form and any additional agency-specific information must be submitted electronically using the Just-in-Time feature in the eRA Commons. Applicants must continue to comply with NIH Other Support disclosure requirements as provided in Section 2.5.1. SBC applicants applying to CDC and FDA will follow each agency's policies for submitting additional documents during the pre-award process. Applicants may be required to provide similar information on the SBIR STTR Foreign Disclosure Form that is also submitted as a part of the other support reporting for senior/key personnel identified in the application. Applicants that do not submit the completed SBIR STTR Foreign Disclosure Form during the JIT process will not be considered for funding.

Denial of Awards

Applicants are encouraged to consider whether their entity's relationships with foreign countries of concern will pose a security risk. Prior to issuing an award, NIH, CDC, and FDA will determine whether the SBC submitting the application:

• has an owner or covered individual that is party to a malign foreign talent recruitment program;

• has a business entity, parent company, or subsidiary located in the People's Republic of China or another foreign country of concern; or

• has an owner or covered individual that has a foreign affiliation with a research institution located in the People's Republic of China or another foreign country of concern.

A finding of foreign involvement with countries of concern will not necessarily disqualify an applicant. NIH, CDC, and FDA will provide SBC applicants the opportunity to address any identified security risks prior to award. Final award determinations will be based on whether the applicant's involvement falls within any of the following risk criteria, per the Act:

• interfere with the capacity for activities supported by NIH, CDC, or FDA to be carried out;

• create duplication with activities supported by NIH, CDC, or FDA;

• present concerns about conflicts of interest;

• were not appropriately disclosed to NIH, CDC, or FDA;

• violate Federal law or terms and conditions of NIH, CDC, or FDA; or

• pose a risk to national security.

NIH, CDC, and FDA will not issue an award under the SBIR/STTR program if the covered relationship with a foreign country of concern identified in this guidance is determined to fall under any of the criteria provided above, and the risk cannot be resolved.