PHS 398 Research Plan Instructions

General Instructions for NIH and Other PHS Agencies - Forms Version F Series

G.400 - PHS 398 Research Plan Form
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The PHS 398 Research Plan form is used only for research,
multi-project, and SBIR/STTR applications.
This form includes fields to upload several attachments, including
the Specific Aims and Research Strategy.
The Research Plan, together with the rest of your application,
should include sufficient information needed for evaluation of the
project, independent of any other documents (e.g., previous
application). Be specific and informative, and avoid redundancies.

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Quick Links
Introduction
1.

1. Introduction to Application (for Resubmission and Revision applications)

Research Plan Section
1.
2.
3.

2. Specific Aims
3. Research Strategy
4. Progress Report Publication List

Other Research Plan Section
1.
2.
3.
4.
5.
6.
7.

5. Vertebrate Animals
6. Select Agent Research
7. Multiple PD/PI Leadership Plan
8. Consortium/Contractual Arrangements
9. Letters of Support
10. Resource Sharing Plan(s)
11. Authentication of Key Biological and/or Chemical Resources

Appendix
1.

12. Appendix

Your application should represent a sound approach to the investigation of an important biomedical
research, behavioral research, technological, engineering, or scientific question, and be worthy of support
under the stated criteria of the FOA. It should be self-contained and written with the care and
thoroughness accorded to papers for publication.

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Review the application carefully to ensure you have included information essential for evaluation. The
scientific and technical merit of the proposed research is the primary concern for all research supported
by the National Institutes of Health (NIH) and other PHS agencies.
Read all the instructions in the FOA before completing this form to ensure that your application meets all
IC-specific criteria.
Who should use the PHS 398 Research Plan Form:
Use the PHS 398 Research Plan Form only if you are submitting a research, multi-project, or SBIR/STTR
application.
Additional Instructions for SBIR/STTR:
You are strongly encouraged to contact agency program staff for pre-application guidance and/or for
more specific information on the research topics described in the solicitation. You can find the
contact information for each Institute and Center representative here.
CRP uses SBIR funding but is not a Phase I/II/IIB or Fast-Track application. However, CRP applications
should follow all Phase II-specific instructions and those in the CRP solicitations.
Sample SBIR/STTR Applications can be accessed here.
Applicants must follow all policies and requirements related to formatting, page limits, and
proprietary information. See the following pages for more information:
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•
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Format Attachments
Page Limits
NIH Grants Policy Statement, Section 2.3.11.2: Confidentiality of Information
NIH Grants Policy Statement, Section 2.3.11.2.2: The Freedom of Information Act

Introduction
1. Introduction to Application (for Resubmission and Revision applications)
Who must complete the “Introduction to Application” attachment:
An "Introduction to Application" attachment is required only if the type of application is
resubmission or revision or if the FOA specifies that one is needed. An introduction is not allowed for
new or renewal applications.
Descriptions of different types of applications are listed here: NIH Types of Applications.
Format:
Follow the page limits for the introduction in the NIH Table of Page Limits unless otherwise specified
in the FOA.
Attach this information as a PDF file. See NIH's Format Attachments page. Hyperlinks and URLs may
not be used in this section unless specified as allowed in the funding opportunity announcement.

General Instructions for NIH and Other PHS Agencies - Forms Version F Series

Content:
Resubmission applications: See specific instructions on the content of the introduction on the
NIH's Resubmission Applications page.
Competing Revisions: See specific instructions on the content of the introduction on the NIH's
Competing Revisions page.
Additional Instructions for Multi-project:
Overall Component: The “Introduction” attachment is required for all resubmission and revision
applications.
Other Components: The "Introduction” attachment is optional for resubmissions and revisions
applications. Although the “Introduction” attachment is optional, you may get a system warning if
there is no attachment.

Research Plan Section
2. Specific Aims
Who must complete the "Specific Aims" attachment:
The “Specific Aims” attachment is required unless otherwise specified in the FOA.
Format:
Follow the page limits for the Specific Aims in the NIH Table of Page Limits unless otherwise
specified in the FOA. A “Specific Aims” attachment that exceeds the page limit will be flagged as an
error by the Agency upon submission.
Attach this information as a PDF file. See NIH's Format Attachments page. Hyperlinks and URLs may
not be used in this section unless specified as allowed in the funding opportunity announcement.
Content:
State concisely the goals of the proposed research and summarize the expected outcome(s),
including the impact that the results of the proposed research will have on the research field(s)
involved.
List succinctly the specific objectives of the research proposed (e.g., to test a stated hypothesis,
create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice,
address a critical barrier to progress in the field, or develop new technology).
Additional Instructions for Multi-project:
Overall Component: The "Specific Aims" attachment is required.
Other Components: The "Specific Aims" attachment is required.

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Additional Instructions for SBIR/STTR:
Phase I Applications: State the specific objectives of the Phase I research and development effort,
including the technical questions you will try to answer to determine the Phase I feasibility of the
proposed approach and the impact of the proposed research and development. State concisely and
realistically what the proposed R&D is intended to accomplish in terms of its potential for
technological innovation and commercial application. Define the proposed and the process or service
to ultimately be developed. Include clear and measurable milestones for each of the aims as these
will be used in the evaluation process.
Phase II, Phase IIB, and CRP Applications: State the specific objectives of the Phase II or CRP
research and development effort including the impact of the proposed research and development.
State concisely and realistically what the proposed R&D is intended to accomplish in terms of its
potential for technological innovation and commercial application. Define the proposed product,
process, or service to ultimately be developed. Include clear and measurable milestones for each of
the aims as these will be used in the evaluation process.
Fast-Track Applications: Create a heading titled “Phase I Specific Aims” and follow the instructions
above for “Phase I Applications.” Note that your Phase I milestones must be clear, appropriate, and
measurable. It is important to clearly state the go/no-go milestone that will determine transition to
Phase II. Failure to adequately address these criteria may negatively affect the application's impact
score. Next, create a heading titled “Phase II Specific Aims” and follow the instructions above for
“Phase II Applications.” Note that the page limit applies to both phases in combination, not to each
phase individually.

3. Research Strategy
Who must complete the "Research Strategy" attachment:
The “Research Strategy” attachment is required.
Format:
Follow the page limits for the Research Strategy in the NIH Table of Page Limits, unless otherwise
specified in the FOA. Although multiple sections of information are required in the Research Strategy
as detailed below, the page limit applies to the entirety of the single "Research Strategy" attachment.
Attach this information as a PDF file. See NIH's Format Attachments page. Hyperlinks and URLs may
not be used in this section unless specified as allowed in the funding opportunity announcement.
Content:
Organize the Research Strategy in the specified order and use the instructions provided below unless
otherwise specified in the FOA. Start each section with the appropriate heading – Significance,
Innovation, Approach.
Cite published experimental details in the Research Strategy attachment and provide the full
reference in G.220 - R&R Other Project Information Form, Bibliography and Reference Cited.
Note for Applications Proposing the Use of Human Fetal Tissue: If the use of human fetal
tissue obtained from elective abortions (HFT) (as defined in the NIH Grants Policy Statement) is

General Instructions for NIH and Other PHS Agencies - Forms Version F Series

included in the proposed application you must include specific information in the Approach section
of the Research Strategy attachment. See specific instructions below in Section 3. Approach. This
information must be provided regardless of whether Human Subjects research is proposed or not.
Applications proposing HFT that do not address these requirements will be administratively
withdrawn. For further information on HFT policy refer to the NIH Grants Policy Statement, Section
2.3.7.11 Human Fetal Tissue from Elective Abortions, Section 4.1.14 Human Fetal Tissue Research and
Section 4.1.14.2 Human Fetal Tissue from Elective Abortions.
Note for Applications Proposing the Involvement of Human Subjects and/or Clinical Trials:
•

•

•

Do not duplicate information in the Research Strategy and the PHS Human Subjects and Clinical
Trials Information form. Use the Research Strategy attachment to discuss the overall strategy,
methodology, and analyses of your proposed research. Use the PHS Human Subjects and Clinical
Trials Information form to provide detailed information for human subjects studies and clinical
trials.
The PHS Human Subjects and Clinical Trials Information form will capture detailed study
information, including eligibility criteria; inclusion of women, minorities, and individuals across
the lifespan; protection and monitoring plans; and statistical design and power.
You are encouraged to refer to information in the PHS Human Subjects and Clinical Trials
Information form as appropriate in your discussion of the Research Strategy (e.g., see Question
2.4 Inclusion of Women and Minorities).

Note for Applicants with Multiple Specific Aims: You may address the Significance, Innovation,
and Approach either for each Specific Aim individually or for all of the Specific Aims collectively.
1. Significance
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Explain the importance of the problem or critical barrier to progress that the proposed
project addresses.
Describe the strengths and weaknesses in the rigor of the prior research (both published
and unpublished) that serves as the key support for the proposed project.
Explain how the proposed project will improve scientific knowledge, technical capability,
and/or clinical practice in one or more broad fields.

Additional Instructions for Research:
Describe how the concepts, methods, technologies, treatments, services, or preventative interventions
that drive this field will be changed if the proposed aims are achieved.

Additional Instructions for Multi-project:
Overall and Other Components: Describe how the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field will be changed if the proposed aims are
achieved.

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Additional Instructions for SBIR/STTR:
Explain the project’s potential to lead to a marketable product, process, or service.
Phase II, CRP, Fast-Track, and Phase IIB Competing Renewals: Explain how the commercialization
plan demonstrates a high probability of commercialization.
2. Innovation
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•

Explain how the application challenges and seeks to shift current research or clinical practice
paradigms.
Describe any novel theoretical concepts, approaches or methodologies, instrumentation or
interventions to be developed or used, and any advantage over existing methodologies,
instrumentation, or interventions.
Explain any refinements, improvements, or new applications of theoretical concepts,
approaches or methodologies, instrumentation, or interventions.

3. Approach
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•

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•
•

•

•

Describe the overall strategy, methodology, and analyses to be used to accomplish the
specific aims of the project. Describe plans to address weaknesses in the rigor of the prior
research that serves as the key support for the proposed project. Describe the experimental
design and methods proposed and how they will achieve robust and unbiased results.
Include how the data will be collected, analyzed, and interpreted, and reference any
Resource Sharing Plans as appropriate. Resources and tools for rigorous experimental
design can be found at the Enhancing Reproducibility through Rigor and Transparency
website.
For trials that randomize groups or deliver interventions to groups, describe how your
methods for analysis and sample size are appropriate for your plans for participant
assignment and intervention delivery. These methods can include a group- or clusterrandomized trial or an individually randomized group-treatment trial. Additional information
is available at the Research Methods Resources webpage.
Discuss potential problems, alternative strategies, and benchmarks for success anticipated to
achieve the aims.
If the project is in the early stages of development, describe any strategy to establish
feasibility, and address the management of any high risk aspects of the proposed work.
Explain how relevant biological variables, such as sex, are factored into research designs and
analyses for studies in vertebrate animals and humans. For example, strong justification from
the scientific literature, preliminary data, or other relevant considerations, must be provided
for applications proposing to study only one sex. Refer to the NIH Guide Notice on Sex as a
Biological Variable in NIH-funded Research for additional information.
Point out any procedures, situations, or materials that may be hazardous to personnel and
the precautions to be exercised. A full discussion on the use of select agents should appear
in the Select Agent Research attachment below.
If research on Human Embryonic Stem Cells (hESCs) is proposed but an approved cell line
from the NIH hESC Registry cannot be chosen, provide a strong justification for why an
appropriate cell line cannot be chosen from the registry at this time.

General Instructions for NIH and Other PHS Agencies - Forms Version F Series

Special Instructions for Applications Proposing the Use of Human Fetal Tissue: If the use of
human fetal tissue obtained from elective abortions (HFT) (as defined in the NIH Grants Policy
Statement) is included in the proposed application
•
•
•

Use the specific heading: “Human Fetal Tissue Research Approach”.
Describe the proposed characteristics, procurement, and procedures for the research use of HFT.
The description should be sufficiently detailed to permit meaningful evaluation by NIH.
Justify the use of HFT in the proposed research by indicating the following:
• Why the research goals cannot be accomplished by using an alternative to HFT.
• What methods were used (e.g. literature review, preliminary data) to determine that
alternatives could not be used.
• Results from a literature review used to provide justifications.
• Plans for the treatment of HFT and the disposal of HFT when research is complete.
• Description of planned written, voluntary, informed consent process for cell/tissue
donation, or description and documentation of process if cells/tissue were already
obtained.

Applications proposing HFT that do not address these requirements will be administratively
withdrawn. For further information on HFT policy refer to the NIH Grants Policy Statement, Section
2.3.7.11 Human Fetal Tissue from Elective Abortions, Section 4.1.14 Human Fetal Tissue Research and
Section 4.1.14.2 Human Fetal Tissue from Elective Abortions.
Additional Instructions for SBIR/STTR:
Provide a tentative sequence or timetable for the project.
As applicable, also include the following information as part of the Research Strategy, keeping
within the three sections (Significance, Innovation, and Approach) listed above.
Preliminary Studies for New Applications:
For new applications, include information on preliminary studies. Discuss the PD/PI’s preliminary
studies, data, and or experience pertinent to this application. Except for Exploratory/Developmental
Grants (R21/R33), Small Research Grants (R03), and Academic Research Enhancement Award (AREA)
Grants (R15), preliminary data can be an essential part of a research grant application and can help
to establish the likelihood of success of the proposed project. Early stage investigators should
include preliminary data.

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Additional Instructions for SBIR/STTR:
Phase I Applications: Preliminary data are not required for Phase I Applications; however, such
results may assist reviewers in assessing the likelihood of success of the proposed project and may be
included in the Research Strategy attachment.
Fast-Track Applications: While not required, preliminary data are expected for Fast-Track
Applications.
SBIR Direct Phase II: Summarize the specific aims of the preliminary work that forms the basis for
this Phase II application, quantitative milestones (i.e., a quantitative definition of success) for each
aim, and the importance of the findings. Additionally, emphasize the progress made toward each
aim’s achievement. Describe the technology developed, its intended use, and who will use it. Provide
data or evidence of the capability, completeness of design, and efficacy, along with the rationale for
selection of the criteria used to validate the technology, prototype, or method. Describe the current
status of the product (e.g., under development, commercialized, in use, discontinued). If applicable,
describe the status of FDA approval for your product, process, or service (e.g., continuing pre-IND
studies, filed on IND, in Phase I (or II or III) clinical trials, applied for approval, review ongoing,
approved, not approved). List the generic and/or commercial names of products. A list of
publications, patents, and other printed materials should be included in Item 5 (Progress Report
Publication List) – do not include that information here.
Progress Report for Renewal and Revision Applications:
Note that the Progress Report falls within the Research Strategy and is therefore included in the
page limits for the Research Strategy.
For renewal/revision applications, provide a Progress Report. Provide the beginning and ending
dates for the period covered since the last competitive review. In the Progress Report, you should:
•
•
•

Summarize the specific aims of the previous project period and the importance of the
findings, and emphasize the progress made toward their achievement.
Explain any significant changes to the specific aims and any new directions, including
changes resulting from significant budget reductions.
Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women,
minorities, children, etc.) for any studies meeting the NIH definition for clinical research. Use
the Progress Report section to discuss, but not duplicate information collected elsewhere in
the application.

Do not include a list of publications, patents, or other printed materials in the Progress Report. That
information will be included in the "Progress Report Publication List" attachment.

General Instructions for NIH and Other PHS Agencies - Forms Version F Series

Additional Instructions for SBIR/STTR:
Phase II, Phase IIB, and CRP Competing Renewal and Revision Applications: In the Progress
Report, in addition to what’s listed above, describe the technology developed from the previously
supported SBIR/STTR award, and (if different from the proposed application) its intended use, and
who will use it. Describe the current status of the product (e.g., under development, commercialized,
in use, discontinued). If applicable, describe the status of FDA approval for your product, process, or
service (e.g., continuing pre-IND studies, filed on IND, in Phase I (or II or III) clinical trials, applied for
approval, review ongoing, approved, not approved).

4. Progress Report Publication List
Who must complete the “Progress Report Publication List” attachment:
A “Progress Report Publication List” attachment is required only if the type of application is renewal.
Descriptions of different types of applications are listed here: NIH's Types of Applications.
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page. Use of hyperlinks and
URLs in this section is not allowed unless specified in these instructions or in the funding opportunity
announcement.
Content:
List the titles and complete references to all appropriate publications, manuscripts accepted for
publication, patents, and other printed materials that have resulted from the project since it was last
reviewed competitively.
You are allowed to cite interim research products. Note: interim research products have specific
citation requirements. See related Frequently Asked Questions on citing interim research products
and claiming them as products of your NIH award.
Provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed
Central (PMC) reference number (e.g., PMCID234567) for each of the following:
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•
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Articles that fall under the Public Access Policy,
Articles that were authored or co-authored by the applicant and arose from NIH support,
Articles that were authored or co-authored by the applicant and arose from AHRQ funding
provided after February 19, 2016 (see the Guide Notice on Policy for Public Access to AHRQFunded Scientific Publications).

If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of
their authors, indicate “PMC Journal – In Process.” NIH maintains a list of such journals.
Citations that are not covered by the Public Access Policy, but are publicly available in a free, online
format may include URLs or PubMed ID (PMID) numbers along with the full reference. Active
hyperlinks are not allowed.

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Additional Instructions for Multi-project:
Overall and Other Components: If you include a "Progress Report Publication List" attachment, you
can include it in either the Overall Component or within each Other Component, but do not attach
the same information in multiple locations.

Additional Instructions for SBIR/STTR:
Phase II, Phase IIB, and CRP Applications: List the titles and complete references to all appropriate
publications, manuscripts accepted for publication, patents, copyrights, trademarks, invention reports
and other printed materials, if any, that resulted from the Phase I or describe patent status, trade
secrets or other demonstration of IP protection, and other printed materials that have resulted from
the Phase I effort.

Other Research Plan Section
5. Vertebrate Animals
Who must complete the “Vertebrate Animals” attachment:
Include a “Vertebrate Animals” attachment if you answered “Yes” to the question “Are Vertebrate
Animals Used?” on the G.220 - R&R Other Project Information Form.
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.
Do not use this attachment to circumvent the page limits of the Research Strategy.
Content:
If live vertebrate animals are involved in the project, address each of the following criteria:
1.

2.
3.

Description of Procedures: Provide a concise description of the proposed procedures to be
used that involve live vertebrate animals in the work outlined in the “Research Strategy”
attachment. The description must include sufficient detail to allow evaluation of the
procedures. Identify the species, strains, ages, sex, and total numbers of animals by species,
to be used in the proposed work. If dogs or cats are proposed, provide the source of the
animals.
Justifications: Provide justification that the species are appropriate for the proposed
research. Explain why the research goals cannot be accomplished using an alternative model
(e.g. computational, human, invertebrate, in vitro).
Minimization of Pain and Distress: Describe the interventions including analgesia,
anesthesia, sedation, palliative care and humane endpoints that will be used to minimize
discomfort, distress, pain, and injury.

Each of the criteria must be addressed. Failure to adequately address the criteria may negatively
affect the application’s impact score. In addition to the 3 criteria above, you should also:

General Instructions for NIH and Other PHS Agencies - Forms Version F Series

•
•

Identify all project performance (or collaborating) sites and describe the proposed research
activities with vertebrate animals that will be conducted at those sites.
Explain when and how animals are expected to be used if plans for the use of animals have
not been finalized.

See the following pages for more information:
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•
•

NIH’s Office of Laboratory Animal Welfare website
NIH's Vertebrate Animals Section Worksheet
See the NIH Grants Policy Statement, Section 4.1.1: Animal Welfare Requirements (an applicable
Animal Welfare Assurance will be required if the grantee institution does not have one)
Additional Instructions for Multi-project:
Overall Component: The “Vertebrate Animals” attachment is optional unless specifically requested in
the FOA.
Other Components: Complete the “Vertebrate Animals” section if you answered “Yes” to the
question “Are Vertebrate Animals Used?” on the G.220 - R&R Other Project Information Form.

6. Select Agent Research
Who must complete the “Select Agent Research” attachment:
Include a “Select Agent Research” attachment if your proposed activities involve the use of select
agents at any time during the proposed project period, either at the applicant organization or at any
performance site.
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.
For more information:
Select agents are hazardous biological agents and toxins that have been identified by HHS or
the U.S. Department of Agriculture (USDA) as having the potential to pose a severe threat to public
health and safety, to animal and plant health, or to animal and plant products. The Centers for
Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS)
Select Agent Programs jointly maintain a list of these agents. See the Federal Select Agent Program
website.
See also the NIH Grants Policy Statement, Section 4.1.24.1.1: Select Agents.
Content:
Excluded select agents: If the activities proposed in the application involve only the use of a
strain(s) of select agents which has been excluded from the list of select agents and toxins as per 42
CFR 73.3, the select agent requirements do not apply. Use this “Select Agent Research” attachment
to identify the strain(s) of the select agent that will be used and note that it has been excluded from
this list. The CDC maintains a list of exclusions, which is available on the Select Agents and Toxins
Exclusions website.

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Applying for a select agent to be excluded: If the strain(s) is not currently excluded from the list of
select agents and toxins but you have applied or intend to apply to HHS for an exclusion from the
list, use this section to indicate the status of your request or your intent to apply for an exclusion and
provide a brief justification for the exclusion.
All applicants proposing to use select agents: Address the following three points for each site at
which select agent research will take place. Although no specific page limitation applies to this
section, be succinct.
1.
2.

3.

Identify the select agent(s) to be used in the proposed research.
Provide the registration status of all entities* where select agent(s) will be used.
• If the performance site(s) is a foreign institution, provide the name(s) of the country or
countries where select agent research will be performed.
• *An “entity” is defined in 42 CFR 73.1 as “any government agency (Federal, State, or
local), academic institution, corporation, company, partnership, society, association,
firm, sole proprietorship, or other legal entity.”
Provide a description of all facilities where the select agent(s) will be used.
• Describe the procedures that will be used to monitor possession, use, and transfer of
select agent(s).
• Describe plans for appropriate biosafety, biocontainment, and security of the select
agent(s).
• Describe the biocontainment resources available at all performance sites.

7. Multiple PD/PI Leadership Plan
Who must complete the “Multiple PD/PI Leadership Plan” attachment:
Any applicant who designates multiple PD/PIs (on the G.240 - R&R Senior/Key Person Profile
(Expanded) Form) must include a Multiple PD/PI Leadership Plan. For applications designating
multiple PD/PIs, all such individuals must be assigned the PD/PI role on the G.240 - R&R Senior/Key
Profile (Expanded) Form, even those at organizations other than the applicant organization.
Do not submit a Multiple PD/PI Leadership Plan if you are not submitting a multiple PD/PI
application.
Additional Instructions for Multi-project:
Overall Component: The “Multiple PD/PI Leadership Plan” attachment is required if more than one
PD/PI is specified on the Overall Component's G.240 - R&R Senior/Key Profile (Expanded) Form.
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
A rationale for choosing a multiple PD/PI approach should be described. The governance and
organizational structure of the leadership team and the research project should be described,
including communication plans, processes for making decisions on scientific direction, and
procedures for resolving conflicts. The roles and administrative, technical, and scientific

General Instructions for NIH and Other PHS Agencies - Forms Version F Series

responsibilities for the project or program should be delineated for the PD/PIs and other
collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or
the individual PD/PIs should be delineated in the Multiple PD/PI Leadership Plan. In the event of an
award, the requested allocations may be reflected in a footnote on the Notice of Grant Award.
For more information:
For background information on the multiple PD/PI initiative, see NIH's Multiple Principal
Investigators page.

8. Consortium/Contractual Arrangements
Who must complete the “Consortium/Contractual Arrangements” attachment:
Include a “Consortium/Contractual Arrangements” attachment if you have consortiums/contracts in
your budget.
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant
organization and the consortium organization(s). If consortium/contractual activities represent a
significant portion of the overall project, explain why the applicant organization, rather than the
ultimate performer of the activities, should be the grantee.
Note: The signature of the authorized organization representative in G.200 - SF 424 (R&R),
Authorized Representative signifies that the applicant and all proposed consortium participants
understand and agree to the following statement:
The appropriate programmatic and administrative personnel of each organization involved in this
grant application are aware of the agency’s consortium agreement policy and are prepared to
establish the necessary inter-organizational agreement(s) consistent with that policy.
For more information:
Refer to the NIH Grants Policy Statement, Section 15: Consortium Agreements for more information.

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Additional Instructions for Multi-project:
Overall and Other Components: Unless otherwise specified in the FOA, you have the option to:
•
•
•

include a single consolidated “Consortium/Contractual Arrangements” attachment in the Overall
Component, or
include component-specific “Consortium/Contractual Arrangements” attachment(s) within the
components that include subawards, or
include a “Consortium/Contractual Arrangements” attachment in the Overall Component and
include component-specific attachments within the components that include subawards. Each
filename must be unique.

General Instructions for NIH and Other PHS Agencies - Forms Version F Series

Additional Instructions for SBIR/STTR:
SBIR:
Phase I Applications: Normally, a minimum of two-thirds or 67% of the research or analytical effort
must be carried out by the small business. The total amount of all consultant and contractual
arrangements to third parties for portions of the scientific and technical effort generally may not
exceed 33% of the total amount requested (direct, F&A/indirect, and fee). Occasionally, deviations
from these requirements may occur. Deviations must be approved in writing by the funding
agreement officer after consultation with the agency SBIR Program Manager/Coordinator.
Phase II and Phase IIB Applications: Normally, a minimum of one-half or 50% of the research or
analytical effort must be carried out by the small business. The total amount of consultant and
contractual arrangements to third parties for portions of the scientific and technical effort generally
may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).
Occasionally, deviations from these requirements may occur. Deviations must be approved in writing
by the funding agreement officer after consultation with the agency SBIR Program
Manager/Coordinator.
Phase I and Phase II Applications: The basis for determining the percentage of work to be
performed by each of the cooperative parties in Phase I or Phase II will be the total requested costs
(direct, F&A/indirect, and fee) attributable to each party, unless otherwise described and justified in
this attachment.
Fast-Track SBIR Applications: Create two separate sections entitled “Phase I
Consortium/Contractual Arrangements” and “Phase II Consortium/Contractual Arrangements,” and
complete the sections following the instructions provided above for each phase.
STTR:
Phase I, Phase II and Phase IIB STTR Applications: At least 40% of the work must be performed by
the small business and at least 30% of the work must be performed by the single partnering research
institution. The basis for determining the percentage of work to be performed by each of the
cooperative parties will be the total of the requested costs (direct, F&A/indirect, and fee) attributable
to each party, unless otherwise described and justified in this attachment.
Certification showing the cooperative R&D arrangement between the small business and the research
institution will be requested prior to an award.
The single partnering research institution must certify at the time of application that at least 30% of
the work of the STTR project will be performed by the research institution. This 30% requirement
applies to the single collaborating organization identified as the “research institution.”
The requisite signature, printed name, title, and date of signature of the duly authorized
representative of the research institution affirming certifications made by the research institution
must be included in a letter stating:
“The small business concern and the research institution certify jointly that: (1) the proposed
STTR project will be conducted jointly by the small business concern and the research
institution in which not less than 40 percent of the work will be performed by the small
business concern and not less than 30 percent of the work will be performed by the research
institution (“cooperative research and development”); (2) the proposed STTR project is a

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cooperative research or research and development effort to be conducted jointly by the small
business concern and the research institution in which not less than 40 percent of the work will
be performed by the small business concern and not less than 30 percent of the work will be
performed by the research institution (“performance of research and analytical work”); and (3)
regardless of the proportion of the proposed project to be performed by each party, the small
business concern will be the primary party that will exercise management direction and control
of the performance of the project.
If the research institution is a contractor-operated Federally Funded Research and Development
Center (FFRDC), the duly authorized representative of the contractor-operated Federally funded
research and development center certifies, additionally, that it: “(4) is free from organizational
conflicts of interests relative to the STTR program; (5) did not use privileged information gained
through work performed for an STTR agency or private access to STTR agency personnel in the
development of this STTR grant application; and (6) used outside peer review, as appropriate, to
evaluate the proposed project and its performance therein.”
The applicant small business should convert the letter from the partnering research institution into a
PDF attachment, and include it as part of this attachment.
Fast-Track STTR Applications: Create two separate sections entitled “Phase I
Consortium/Contractual Arrangements” and “Phase II Consortium/Contractual Arrangements,” and
complete the sections following the instructions provided above for each phase.

9. Letters of Support
Format:
Combine all letters of support into a single PDF file and attach this information here. Do not place
these letters in the Appendix.
Follow the attachment guidelines on NIH's Format Attachments page. Use of hyperlinks and URLs in
Letters of Support is not allowed unless specified in the funding opportunity announcement.
Content:
Attach a file with all letters of support, including any letters necessary to demonstrate the support of
consortium participants and collaborators such as Senior/Key Personnel and Other Significant
Contributors included in the grant application.
Letters should stipulate expectations for co-authorship, and whether cell lines, samples, or other
resources promised in the letter are freely available to other investigators in the scientific community
or will be provided to the particular investigators only.
For consultants, letters should include rate/charge for consulting services and level of effort/number
of hours per budget period anticipated. In addition, letters ensuring access to core facilities and
resources should stipulate whether access will be provided as a fee-for-service. Material Transfer
Agreements may be included in this section.
Letters must focus on the topics listed above and not contain data/figures/tables/graphs,
preliminary data, methods, background and significance details that are expected to be found in
Research Strategy section of the application. Letters of Support serve to describe terms of a
collaboration or consultation and also are not de facto letters of reference from persons not actively

General Instructions for NIH and Other PHS Agencies - Forms Version F Series

participating in the project. Applications with letters containing such excess information may be
withdrawn from the review process.
Letters are not required for personnel (such as research assistants) not contributing in a substantive,
measurable way to the scientific development or execution of the project.
Do not include consultant biographical sketches in the “Letters of Support” attachment, as consultant
biosketches should be in the “Biographical Sketch” section (see exception for SBIR/STTR Applications
in the SBIR/STTR-specific instructions).
Additional Instructions for Multi-project:
Overall and Other Components: Unless specific instructions are provided in the FOA, applicants
have the option of including the “Letters of Support” attachment in the Overall Component, Other
Components, or both. To avoid duplication, each letter should appear only once in the application.
Letters that apply to the entire application (or to multiple components) should be presented in the
Overall Component as a single PDF, while letters that apply only to a particular individual component
should be presented in that component as a single PDF.

Additional Instructions for SBIR/STTR:
Involvement of consultants and collaborators in the planning and research stages of the project is
permitted. With the application, letters are required from each individual and/or collaborator
confirming their role(s) in the project. The letter(s) should be prepared on the consultant or
collaborator’s letterhead and addressed to the small business. One page is recommended.
At a minimum, each consultant and collaborator letter should (1) verify their commitment to the
project; (2) refer to the specific project by name, acknowledging the PD/PI as the lead on the project;
and (3) specify what services/tasks the consultant or collaborator will contribute (e.g. expertise,
number of hours/ percent of effort, summary of tasks to be completed). For consultants, the letter
should also include the rate/charge for consulting services. Also include biographical sketches for
each consultant.
Letters of interest from potential commercial partners or investors and letters of commitment of
funds or other resources that will enhance the likelihood of commercialization should be placed
following the letters of support for consultants and collaborators. Letters from potential or current
users of the technology or product proposed in the application should be limited and directly
relevant to the proposed project.
STTR only: The single “partnering” research institution must provide a letter to the applicant small
business concern certifying that at least 30% of the work of the STTR project will be performed by the
research institution.

10. Resource Sharing Plan(s)
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.

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Content:
Data Sharing Plan: Investigators seeking $500,000 or more in direct costs (exclusive of consortium
F&A) in any budget period are expected to include a brief 1-paragraph description of how final
research data will be shared, or explain why data-sharing is not possible (for example human subject
concerns, the Small Business Innovation Development Act provisions, etc.). Specific FOAs may require
that all applications include this information regardless of the dollar level. Applicants are encouraged
to read the FOA carefully and discuss their data-sharing plan with their program contact at the time
they negotiate an agreement with the Institute/Center (IC) staff to accept assignment of their
application. For more information, see the NIH Data Sharing Policy or the NIH Grants Policy
Statement, Section 2.3.7.10: NIH Genomic Data Sharing and Section 8.2.3.3: Genomic Data Sharing
(GDS) Policy/ Policy for Genome-Wide Association Studies (GWAS).
Sharing Model Organisms: Regardless of the amount requested, all applications where the
development of model organisms is anticipated are expected to include a description of a specific
plan for sharing and distributing unique model organisms or state why such sharing is restricted or
not possible. For more information, see the NIH Grants Policy Statement, Section 8.2.3.2: Sharing
Model Organisms.
Genomic Data Sharing (GDS): Applicants seeking funding for research that generates large-scale
human or non-human genomic data are expected to provide a plan for sharing of these data.
Examples of large-scale genomic data include genome-wide association studies (GWAS), single
nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and
gene expression data. Supplemental Information to the NIH GDS Policy provides examples of
genomic research projects that are subject to the Policy. For guidance on developing a Genomic
Data Sharing Plan, please see NIH Guidance for Developing Genomic Data Sharing Plans for NIHFunded Studies. For more information see the NIH GDS Policy, the NIH Grants Policy Statement,
Section 8.2.3.3: Genomic Data Sharing (GDS) Policy/ Policy for Genome-Wide Association Studies
(GWAS), and the GDS website.
Note on GDS: For proposed studies generating human genomic data under the scope of the GDS
Policy, an institutional certification may be submitted at the time of application submission, but it is
not required at that time. The institutional certification, however, will be requested as Just-in-Time
(JIT) information prior to award. The institutional certification, or in some cases, a provisional
institutional certification, must be submitted and accepted before the award can be issued.
For more information:
NIH considers the sharing of unique research resources developed through NIH-sponsored research
an important means to enhance the value and further the advancement of the research. When
resources have been developed with NIH funds, and the associated research findings published or
provided to NIH, it is important that they be made readily available for research purposes to
qualified individuals within the scientific community. See the NIH Grants Policy Statement, Section
8.2.3: Sharing Research Resources.

11. Authentication of Key Biological and/or Chemical Resources
Format:
Attach this information as a PDF file. See NIH's Format Attachments page.

General Instructions for NIH and Other PHS Agencies - Forms Version F Series

Content:
If applicable to the proposed science, briefly describe methods to ensure the identity and validity of
key biological and/or chemical resources used in the proposed studies. A maximum of one page is
suggested.
For more Information:
Key biological and/or chemical resources are characterized as follows.
•

•
•

Key biological and/or chemical resources may or may not have been generated with NIH
funds and: 1) may differ from laboratory to laboratory or over time; 2) may have qualities
and/or qualifications that could influence the research data; and 3) are integral to the
proposed research. These include, but are not limited to, cell lines, specialty chemicals,
antibodies, and other biologics.
Standard laboratory reagents that are not expected to vary do not need to be included in
the plan. Examples are buffers and other common biologicals or chemicals.
See NIH's page on Rigor and Reproducibility for more information.

Appendix
12. Appendix
Refer to the FOA to determine whether there are any special appendix instructions for your
application. See the updated NIH Guide Notice on the Appendix Policy.
Additional Instructions for Multi-project:
Overall and Other Components: The "Appendix” attachment is optional.

Additional Instructions for SBIR/STTR:
Phase I SBIR/STTR Applications: Do not include appendices unless specifically solicited by NIH.
Format:
A maximum of 10 PDF attachments is allowed in the Appendix. If more than 10 allowable appendix
attachments are needed, combine the remaining information into attachment #10.
Use filenames for attachments that are descriptive of the content.
A summary sheet listing all of the items included in the Appendix is encouraged but not required.
When including a summary sheet, it should be included in the first appendix attachment.
Content:
The only allowable appendix materials are:
•

Blank data collection forms, blank survey forms, and blank questionnaire forms - or
screenshots thereof

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•

Simple lists of interview questions
Note: In your blank forms and lists, do not include items such as: data, data compilations,
lists of variables or acronyms, data analyses, publications, manuals, instructions,
descriptions or drawings/figures/diagrams of data collection methods or
machines/devices.

•
•

Blank informed consent/assent forms
Other items only if they are specified in the FOA as allowable appendix materials

No other items are allowed in the Appendix. Simply relocating disallowed materials to other parts of
the application will result in a noncompliant application.
Some FOAs may have different instructions for the Appendix. Always follow the instructions in your
FOA if they conflict with these instructions.
Note: Applications will be withdrawn and not reviewed if they do not follow the appendix
requirements in these instructions or in your FOA.
Information that expands upon or complements information provided in any section of the
application – even if it is not required for the review – is not allowed in the Appendix unless it is
listed in the allowed appendix materials above or in your FOA. For example, do not include material
transfer agreements (MTA) in the appendix unless otherwise specified in the FOA.
For more information:
•
•

•

The NIH Guide Notice on Reminder: NIH Applications Must Be Complete and Compliant
With NIH Policy and Application Instructions At Time of Submission.
Failure of reviewers to address non-required appendix materials in their reviews is not an
acceptable basis for an appeal of initial peer review. For more information, see the NIH
Grants Policy Statement, Section 2.4.2: Appeals of Initial Scientific Review.
Appendix Policy Frequently Asked Questions