PHS 398 Research Plan Instructions

G.400 - PHS 398 Research Plan Form
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. Introduction to Application (for Resubmission and
Revision applications)

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

Other Research Plan Section
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
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.
The applicant small business must not propose market research, patent
applications, or litigation. The research proposed in this application may, however,
be carried out through construction and evaluation of a laboratory prototype,
where necessary.
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.
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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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.

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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.This section is limited to text only. Graphics (including images, charts, and
graphs) are not allowed in this section. A “Specific Aims” attachment that exceeds the page limit
will be flagged as an error by the Agency upon submission, and a “Specific Aims” attachment that
includes graphics will generate a warning by the Agency upon submission.
Attach this information as a PDF file. See NIH's Format Attachments page.
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 that the
results of the proposed research will exert on the research field(s) involved. State
concisely and realistically what the proposed research 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 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 research and development effort including the impact that the results of
the proposed research will exert on the research field(s). State concisely and
realistically what the proposed research 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
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. 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.
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 included in the proposed
application, you must include specific information in the Approach section of the Research Strategy attachment. See
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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:
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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 children;
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.
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.

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2. Innovation
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Explain how the application challenges and seeks to shift current research or clinical
practice paradigms.

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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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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. Unless addressed separately in the Resource Sharing Plan, include how
the data will be collected, analyzed, and interpreted, as well as 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.

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:

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• 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.

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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.
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: Preliminary data are expected for Fast-Track Applications.
SBIR Direct Phase II (if this is an allowable application type): 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:
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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.

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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 this SBIR/STTR, 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.
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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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 AHRQ-Funded 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.
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.

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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. 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.
2. 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).
3. 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:
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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.

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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 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.
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.

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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. Identify the select agent(s) to be used in the proposed research.
2. Provide the registration status of all entities* where select agent(s) will be used.
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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.”

3. Provide a description of all facilities where the select agent(s) will be used.
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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
responsibilities for the project or program should be delineated for the PD/PIs and other
collaborators.

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

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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 concern (SBC). 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 SBC. 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 SBC 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 SBC 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

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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 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 SBC 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.
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.

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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 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, include letters 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 SBC.
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.
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.).

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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 largescale 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 provides
examples of genomic research projects that are subject to the Policy. 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.
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.

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





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
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

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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

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