PHS Career Development Award Supplemental Instructions

G.410 - PHS 398 Career Development
Award Supplemental Form
The PHS 398 Career Development Award Supplemental
Form is used only for career development applications
and multi-project applications with an "Indiv. Career
Dev" Component.
This form includes fields to upload several attachments
including the Specific Aims, Research Strategy, and
Candidate Background and Goals.
See NIH's Reference Letters page for information
including instructions for referees and how to submit
letters.
The attachments in this form, together with the rest of
your application, should include sufficient information
needed for evaluation of the project and the candidate,
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)

Candidate Section
2. Candidate Information and Goals for Career Development

Research Plan Section
3. Specific Aims
4. Research Strategy
5. Progress Report Publication List (for Renewal applications)
6. Training in the Responsible Conduct of Research

Other Candidate Information Section
7. Candidate's Plan to Provide Mentoring

Mentor, Co-Mentor, Consultant, Collaborators Section

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8. Plans and Statements of Mentor and Co-Mentor(s)
9. Letters of Support from Collaborators, Contributors, and Consultants

Environment and Institutional Commitment to Candidate Section
10. Description of Institutional Environment
11. Institutional Commitment to Candidate's Research Career Development
12. Description of Candidate’s Contribution to Program Goals

Other Research Plan Sections
13. Vertebrate Animals
14. Select Agent Research
15. Consortium/Contractual Arrangements
16. Resource Sharing
17. Authentication of Key Biological and/or Chemical Resources

Appendix
18. Appendix

Citizenship
19. U.S. Citizen or Non-Citizen National?

Who should use the PHS 398 Career Development Award Supplemental Form:
Use the PHS 398 Career Development Award Supplemental Form only if you are submitting a career
development application or a multi-project application that has an "Indiv. Career Dev" Component.
Some sections of the PHS 398 Career Development Award Supplemental Form are required for all
career development award applications, while others are to be used only when required by the FOA.
Read all the instructions in the FOA before completing this section to ensure your application meets
all IC-specific criteria.
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

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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. 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.
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:
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.

Candidate Section
2. Candidate Information and Goals for Career Development
Who must complete the "Candidate Information and Goals for Career Development"
attachment:
The “Candidate Information and Goals for Career Development” attachment is required.
Format:

Follow the page limits for Candidate Information and Goals for Career Development 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.
Content:

Organize your attachment into three sections, following the headings and specified order below,
and discuss each of the points listed below. Start each section with the appropriate section
heading – Candidate’s Background, Career Goals and Objectives, and Candidate’s Plan for Career

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Development/Training Activities During Award Period. Also include any additional information
requested in the FOA.
Candidate’s Background:
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Describe your past scientific history, indicating how the award fits into past and future
research career development.
If there are consistent themes or issues that have guided previous work, these should be
made clear. Alternatively, if your work has changed direction, indicate the reasons for the
change.

Career Goals and Objectives:
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Describe your short-term and long-term career development goals.
Justify the need for the award by describing how the career development award will
enable you to develop and/or expand your research career.
If applicable (e.g., K24), describe how this award will help you to serve as a mentor to
early career investigators.

Candidate’s Plan for Career Development/Training Activities During Award Period:
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Describe the new or enhanced research skills and knowledge you will acquire as a result
of the proposed award, including, as applicable, expertise in rigorous research design,
experimental methods, quantitative approaches, and data analysis and interpretation.
For non-mentored career development awards, describe any planned release from
teaching, administrative, and/or clinical duties that will help you focus on your research
activities, and if applicable, your mentoring activities.
For mentored career development awards, describe any structured activities that are
part of the developmental plan, such as coursework or workshops that will help you
learn new techniques or develop needed professional skills.
Briefly discuss each of the activities, other than research, in which you expect to
participate.
For each activity, other than research, explain how it relates to the proposed research
and to the career development plan. Indicate the percentage of time to be dedicated to
each activity by year, expressed in person months. For more information about
calculating person months, see NIH's Frequently Asked Questions on Person Months.
You are encouraged to include a timeline, including plans to apply for subsequent grant
support.

Research Plan Section
A Research Plan is required for all types of individual career development awards.
The information in these introductory paragraphs to the Research Plan Section applies to all four
Research Plan attachments: Specific Aims, Research Strategy, Progress Report Publication List,
and Training in the Responsible Conduct of Research.

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The Research Plan is a major part of the overall career development goal. It is important to relate
the proposed research to the candidate's scientific career goals. Describe how the research,
coupled with other developmental activities, will provide the experience, knowledge, and skills
necessary to achieve the objectives of the career development plan. Also describe how the
research and other developmental activities will enable the candidate to launch and conduct an
independent research career or enhance an established research career.
For most types of research, the Research Plan Section should include:
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a specific hypothesis,
a list of the specific aims and objectives that will be used to examine the hypothesis,
a description of the methods/approaches/techniques to be used in each aim,
a discussion of possible problems and how they will be managed, and
alternative approaches that might be tried if the initial approaches do not work.

A Career Development Award (CDA) Research Plan is expected to be tailored to the experience
level of the candidate and to allow him/her to develop the necessary skills needed for further
career advancement. Reviewers will evaluate the plan accordingly. The plan should be achievable
within the requested time period. Pilot or preliminary studies and routine data gathering are
generally not appropriate as the sole part(s) of a CDA Research Plan.
Although candidates for mentored career development awards are expected to write the
Research Plan, the mentor should review a draft of the plan and discuss it in detail with the
candidate. Review by other knowledgeable colleagues is also helpful. Although it is understood
that CDA applications do not require the extensive detail usually incorporated into regular
research grant applications, a fundamentally sound Research Plan that includes a reasonably
detailed Research Strategy section should be provided.

3. 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).

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4. 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.
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.
Start each section with the appropriate heading – Significance, Innovation, Approach.
Cite published experimental details in the Research Strategy section and provide the full
reference in G.220 - R&R Other Project Information Form, Bibliography and References Cited.
In general, less detail will be expected in descriptions of research planned for the future years of
the proposed CDA compared to the initial years’ descriptions. However, sufficient detail should
be provided to enable peer reviewers to determine that the plans for those years, including the
approach to be used, are worthwhile and are likely to enable the candidate to achieve the
objectives of the Research Plan.
Note for mentored CDA applications: Explain the relationship between the candidate’s
research on the CDA and the mentor’s ongoing research program.
Note for non-mentored CDA applications: In general, non-mentored CDA applicants are
expected to have independent, peer-reviewed research support. Applications should include a
brief description of currently funded research, along with a more extensive description of any
new research to be supported by the CDA.

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 specific instructions
below in Section 3. Approach. This information must be provided regardless of whether
Human Subjects research is proposed or not. These specific instructions do not apply
to institutional career development applications (e.g. K12, KL2).
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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Use the Research Strategy section to discuss the overall strategy, methodology, and analyses
of your proposed research, but do not duplicate information collected in the PHS Human
Subjects and Clinical Trials Information form.
The PHS Human Subjects and Clinical Trials Information form will capture detailed study
information, including eligibility criteria; inclusion of women, minorities, and children;

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protection and monitoring plans; and statistical design and power.
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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.

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

2. Innovation
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Explain how the application challenges 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.

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 section,
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 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 precautions to be exercised. A full discussion on the use of select agents should
appear in the Select Agent Research section 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.

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If you are proposing to gain clinical trial research experience (i.e., you will not be leading
an independent clinical trial), briefly describe your role on the clinical trial.

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.
• Note: These specific instructions do not apply to institutional career
development applications (e.g. K12).
• 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.
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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.
Progress Report (for Renewal and Revision Applications):

Most career development applicants will not complete this attachment. However, if you are
required to do so, 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 should be included in the "Progress Report Publication List"
attachment.

5. Progress Report Publication List (for Renewal applications)
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. Most career development applicants will not complete this attachment.
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.

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Provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed
Central (PMC) reference number (e.g., PMCID234567) for 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.

6. Training in the Responsible Conduct of Research
Who must complete the "Training in the Responsible Conduct of Research" attachment:
The “Training in the Responsible Conduct of Research” attachment is required.
Format:

Follow the page limits for the Training in the Responsible Conduct of Research 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.
Content:

Mentored CDA applications should describe a plan to acquire instruction in the responsible
conduct of research (RCR).
Non-mentored (independent) CDA applications should describe a plan to obtain or provide
instruction in RCR, depending on your level of experience with RCR.
Attach a description of plans for obtaining or providing instruction in RCR. This section should
document prior instruction or participation in RCR training during the applicant’s current career
stage (including the date instruction was last completed). This section should also propose plans
to either receive instruction or provide instruction (e.g., to participate as a course lecturer) to
meet the frequency requirement of RCR training (see the “For more information section” below).
The plan must address the five required instructional components outlined in the NIH Policy on
Instruction in the Responsible Conduct of Research (RCR), as more fully described in the NIH
Grants Policy Statement, Section 12.4.1.4: Training in the Responsible Conduct of Research.
1. Format: Describe the required format of instruction, i.e., face-to-face lectures,
coursework, and/or real-time discussion groups (a plan with only on-line instruction is
not acceptable).

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2. Subject Matter: Describe the breadth of subject matter (e.g., conflict of interest,
authorship, data management, human subjects and animal use, laboratory safety,
research misconduct, research ethics).
3. Faculty Participation: Describe the role of the mentor(s) and other faculty involvement
in the instruction.
4. Duration of Instruction: Describe the number of contact hours of instruction, taking
into consideration the duration of the program.
5. Frequency of Instruction: Instruction must occur during each career stage and at least
once every four years. Document any prior instruction during the applicant’s current
career stage, including the inclusive dates instruction was last completed.
The plan may include career stage-appropriate individualized instruction or independent
scholarly activities. Instruction and activities should enhance the applicant’s understanding of
ethical issues related to their specific research activities and the societal impact of that research.
The role of the mentor in RCR instruction must be described.
Renewal Applications: Describe the RCR instruction activities undertaken during the previous
project period as well as future plans for RCR instruction.
For more information:

See the NIH Grants Policy Statement, Section 12.4.1.4: Training in the Responsible Conduct of
Research.

Other Candidate Information Section
7. Candidate’s Plan to Provide Mentoring
Who must complete the “Candidate’s Plan to Provide Mentoring” attachment:

Include the “Candidate’s Plan to Provide Mentoring” attachment only when required by the FOA,
(e.g., K05 and K24).
Format:

Follow the page limits for the Candidate’s Plan to Provide Mentoring 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.
Content:

The plan should provide information about both the candidate’s commitment to serve as a
mentor to other investigators and the candidate’s previous mentoring activities. State the
candidate’s proposed percent effort commitment to the mentoring plan, expressed in person
months. For more information about calculating person months, see NIH's Frequently Asked
Questions on Person Months.
Describe proposed mentoring activities: Describe the setting for mentoring and provide
information about the available pool of mentees with appropriate backgrounds and similar
interests in science as the candidate. Include information sufficient for reviewers to evaluate the
quality of the proposed mentoring experience, including the professional levels of mentees and

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the frequency and kinds of mentoring interactions between the candidate and mentees. Describe
the productivity of the mentoring relationship for the scientific development of the new
scientists as judged by their publications and current research activities.
Describe past mentoring activities: Include sufficient information on the candidate’s past
mentees so that reviewers can evaluate the quality of prior mentoring experiences. Include
information such as the professional levels of mentees, and the frequency and kinds of
mentoring interactions between the candidate and mentees.
Senior level (K05) candidates: Describe any financial and material support from your own
funded research and research resources that will be available to your mentees.

Mentor, Co-Mentor, Consultant, Collaborators Section
8. Plans and Statements of Mentor and Co-Mentor(s)
Who must complete the “Plans and Statements of Mentor and Co-Mentor(s)” attachment:
Any candidate applying for a mentored CDA (see Summary of Career Development Award
Mechanisms table) must include a "Plans and Statement of Mentor and Co-Mentor(s)"
attachment.

All mentored career development applications should identify any and all co-mentors involved
with the proposed research and career development program. The mentor and each co-mentor
must provide a statement as described below.
Format:

Follow the page limits for the Plans and Statements of Mentor and Co-mentor(s) in the NIH Table
of Page Limits unless otherwise specified in the FOA.
The plans and statements must be appended together and uploaded as a single PDF file. See
NIH's Format Attachments page.
Content:

The mentor and co-mentor(s) (if applicable) must each document their role and willingness to
participate in the project, and explain how they will contribute to the development of the
candidate's research career. Each statement should include all of the following:
1. The plan for the candidate's training and research career development. Include
information not only about research, but also about other developmental activities, such
as seminars, scientific meetings, training in RCR, and presentations. Discuss expectations
for publications over the entire period of the proposed project. Define what aspects of
the proposed research project the candidate will be allowed to continue to pursue as
part of his/her independent research program.
2. The source of anticipated support for the candidate’s research project for each year of
the award period.
3. The nature and extent of supervision and mentoring of the candidate, and commitment
to the candidate's development that will occur during the award period.

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4. The candidate's anticipated teaching load for the award period (number and types of
courses or seminars), clinical responsibilities, committee and administrative assignments,
and the portion of time available for research.
5. A plan for transitioning the candidate from the mentored stage of his/her career to the
independent investigator stage by the end of the project period of the award. Describe
the mentor's (or co-mentor’s) previous experience as a mentor, including type of
mentoring (e.g., graduate students, career development awardees, postdoctoral
fellows), number of persons mentored, and career outcomes.
Note for co-mentor statements: Co-mentors must also address the nature of their role in the
career development plan and how the responsibility for the candidate’s development is shared
with the mentor. Describe respective areas of expertise and how they will be combined to
enhance the candidate’s development. Also describe the nature of any resources that will be
committed to this CDA.
Note: If the applicant is proposing to gain experience in a clinical trial as part of his or her
research career development, then the mentor or a member of the mentoring team should
include information in the statement to document leadership of the clinical trial (in addition to
the information above). Include the following:
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Source of funding;
ClinicalTrials.gov Identifier (e.g., NCT87654321), if applicable;
A description of how your expertise is appropriate to guide the applicant in any
proposed clinical trials research experience; and
A statement/attestation that the mentor will be responsible for the clinical trial.
The mentor must have primary responsibility for leading and overseeing the trial and
must describe how she/he will provide this oversight (be careful not to overstate the
candidate’s responsibilities).
Include details on the specific roles/responsibilities of the applicant and mentor, keeping
in mind that the terms of a CDA award do not always permit the candidate to lead a
clinical trial.

Do not place these statements from the mentor(s) and co-mentor(s) in the Appendix.

9. Letters of Support from Collaborators, Contributors, and Consultants
Note that letters of support are not the same as letters of reference (also known as reference
letters), which are required for some K applications. For more information about letters of
reference, see the NIH's Reference Letters page.
From whom are letters of support required? From whom are letters not required?

Letters of support from collaborators, contributors, and consultants will be required for any such
person who will contribute to the scientific development or execution of CDA application’s
proposed project. Follow the requirements for letters of support as listed in the FOA.
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.

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Format:

Follow the page limits for the Letters of Support from Collaborators, Contributors, and
Consultants in the NIH Table of Page Limits unless otherwise specified in the FOA.
Attach all appropriate letters of support. The letters must be appended together and uploaded
as a single PDF file. See NIH's Format Attachments page.
Content:

Letters from consultants should include rates/charges for consulting services.

Mentored CDA applications should identify collaborators, contributors, and consultants
involved with the proposed research and career development program, and not already included
in the “Plans and Statements of Mentor(s) and Co-Mentor(s)” section. Letters should briefly
describe their anticipated contributions and document their role and willingness to participate in
the project. The letters should also briefly describe research materials, data, guidance, or advice
each person will provide.
Non-mentored CDA applications should include letters from collaborators, consultants, and
contributors. Letters should list proposed roles and document their willingness to participate in
the project. The letters should also briefly describe research materials, data, guidance, or advice
each person will provide.

Environment and Institutional Commitment to Candidate Section
10. Description of Institutional Environment
Who must complete the "Description of Institutional Environment" attachment:
The “Description of Institutional Environment” attachment is required.
Format:

Follow the page limits for the Description of Institutional Environment 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.
Content:

Mentored CDA applicants: Describe the institution’s research and career development
opportunities related to your area(s) of interest, including the names of key faculty members and
other investigators relevant to your proposed developmental plan and capable of productive
collaboration with the candidate. Indicate how the necessary facilities and other resources will be
made available for both career enhancement and the research proposed in this application –
refer to the resources description in G.220 - R&R Other Project Information Form, Facilities and
Other Resources in your “Description of Institutional Environment” attachment. Describe
opportunities for intellectual interactions with other investigators, including courses offered,
journal clubs, seminars, and presentations.
Non-mentored CDA applicants: Describe the institution’s research and career development
opportunities related to your area(s) of interest, including the names of other faculty members
who are willing to collaborate with you. Indicate how the necessary facilities and other resources
will be made available for both career enhancement and the research proposed in this

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application – refer to the resources description in G.220 - R&R Other Project Information Form,
Facilities and Other Resources in your “Description of Institutional Environment” attachment.
Describe opportunities for intellectual interactions with other investigators, including journal
clubs, seminars, and presentations.

11. Institutional Commitment to Candidate’s Research Career Development
Who must complete the "Institutional Commitment to Candidate's Research Career
Development" attachment:

The “Institutional Commitment to Candidate’s Research Career Development” attachment is
required.
Format:

Follow the page limits for the Institutional Commitment to Candidate’s Research Career
Development 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.
Content:

The sponsoring institution must provide a document on institutional letterhead that describes
its commitment to the candidate and the candidate’s career development, independent of the
receipt of the CDA. It is also essential to document the institution's commitment to the retention,
development, and advancement of the candidate during the period of the award.
The “Institutional Commitment to Candidate’s Research Career Development” attachment should
generally document the institution’s agreement to provide adequate time, support, equipment,
facilities, and resources to the candidate for research and career development activities. See the
list below for specific items to include in the document.
In the document describing its institutional commitment, the applicant organization must:
1. Agree to release the candidate from other duties and activities so that the candidate can
devote the required percentage of time for development of a research career, as
specified by the FOA. For most K awards, commitment of at least 75 percent or nine
person months of time is required.
a. NIH and other PHS agencies use the concept of "person months" as a metric for
determining percent of effort. For more information about calculating person
months, see NIH's Frequently Asked Questions on Person Months.
2. Describe actions that will be taken to ensure that the candidate can devote the required
time to research career development (e.g., reduction of the candidate's teaching load,
committee and administrative assignments, and clinical or other professional activities
for the current academic year). If the candidate’s clinical or teaching responsibilities will
be reduced, describe how this will be accommodated (e.g., hiring additional staff,
reassigning staff, etc.).
3. Describe the candidate's academic appointment, bearing in mind that the appointment
must be full-time, and that the appointment (including all rights and privileges
pertaining to full faculty status if in an academic setting) and the continuation of salary
should not be contingent upon the receipt of this award.

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4. Describe the proportion of time currently available for the candidate's research and what
the candidate's institutional responsibilities will be if an award is made.
5. Describe how the institution will provide the candidate with appropriate office and
laboratory space, equipment, and other resources (including access to clinical and/or
other research populations) to carry out the proposed Research Plan.
6. Describe how the institution will be supportive of any proposed mentor(s), other staff,
and/or collaborations with other faculty consistent with the career development plan.
Signatures:

The institutional commitment must be dated and signed by the person who is authorized to
commit the institution to the agreements and assurances listed above. In most cases, this
will be the dean or the chairman of the department. The signature must appear over the
signer's name and title at the end of the statement. If the candidate will be working outside
of the applicant institution (i.e., sponsoring institution), signatures from both the
applicant/sponsoring institution and host institutions are required.

The sponsoring institution, through the submission of the application and in the
institutional commitment section, certifies that all items outlined above will be provided and
that the institution will abide by the applicable assurances and PHS policies.
Note: For applicable assurances, see the NIH Grants Policy Statement, Section 4: Public
Policy Requirements, Objectives and Other Appropriation Mandates.

12. Description of Candidate’s Contribution to Program Goals
Who must complete the "Description of Candidate’s Contribution to Program Goals"
attachment:

Applicants to diversity-related FOAs (e.g., diversity-related K01 and diversity-related K22s):
The “Description of Candidate’s Contribution to Program Goals” attachment is required.
All other Career Development applicants: Skip the “Description of Candidate’s Contribution to
Program Goals” attachment, as it is not required.
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:

The sponsoring institution must provide a document on institutional letterhead that explains
how the candidate’s participation will further the goals of the career development program to
promote diversity in health-related research.
For NIH’s Interest in Diversity, see the Notice of NIH's Interest in Diversity.
Signatures:

The “Description of Candidate’s Contribution to Program Goals” attachment must be dated
and signed by an institutional official. In most cases, this will be the dean or the chairman of

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the department. The signature must appear over the signer's name and title at the end of
the statement.

Other Research Plan Sections
13. Vertebrate Animals
Who must complete the “Vertebrate Animals” attachment:

Include the “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 the Vertebrate Animals 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:




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:



NIH’s Office of Laboratory Animal Welfare website
NIH's Vertebrate Animals Section Worksheet

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

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)

14. Select Agent Research
Who must complete the “Select Agent Research” attachment:

Include the “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: Public Health Security and Bioterrorism
Preparedness and Response Act (Select Agents).
Content:

Excluded select agents: If the activities proposed in your 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” section
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.
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.




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.



15. Consortium/Contractual Arrangements
Who must complete the “Consortium/Contractual Arrangements” attachment:
Include the “Consortium/Contractual Arrangements” attachment if you have
consortium/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:






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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16. Resource Sharing
Format:

Attach this information as a PDF file. See NIH's Format Attachments page.
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 8.2.3.1: Data Sharing Policy.
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.

17. Authentication of Key Biological and/or Chemical Resources
Format:

Attach this information as a PDF file. See NIH's Format Attachments page.
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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.
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
18. 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.
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.

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


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

Citizenship
Information on Citizenship Requirements for CDA Applicants:
The candidate must be a citizen or non-citizen national of the United States or its possessions
and territories, or must have been lawfully admitted to the United States for permanent
residence by the time of award EXCEPT if any of the following apply:




candidate is applying to the K99/R00 award program;
candidate is applying to the K43 award program; or
the FOA specifies otherwise.

Note for permanent residents: Before an award is issued, a permanent resident will be required
to submit a notarized statement that the candidate holds a current and valid Permanent Resident
Card or some other valid verification from the U.S. Immigration and Naturalization Service of
legal admission to the U.S. as a permanent resident.
Note for candidates whose citizenship status changes or is expected to change: For those
career development award programs that require candidates to be U.S. citizens or permanent
residents, an individual who has applied for permanent residence and expects to have obtained
such status prior to the time award may submit an application recognizing that no award will be
made until legal verification of permanent resident status is provided. If a candidate’s citizenship
status changes after submission of the application, the new status should be reported in the
candidate’s Personal Profile in the eRA Commons.

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Note on K99/R00 applicants on temporary visas: It is the
responsibility of the applicant organization to determine and
document in the application that the candidate’s visa will allow him or
her to remain in the U.S. long enough to complete the phase of the
award (e.g., K99 or R00) covered by the application. Information may
be requested by the NIH or another PHS Agency prior to issuance of
an award as a Just-in-Time submission.
Check the applicable boxes for the following questions:
19. U.S. Citizen or Non-Citizen National?
Check “Yes” if the candidate is either a U.S. Citizen or a Non-Citizen
national; otherwise check “No.”
Non-Citizen nationals are people who, although not citizens
of the United States, owe permanent allegiance to the United
States. They generally are people born in outlying possessions
of the United States (e.g., American Samoa and Swains Island).
If no, select most appropriate Non-U.S. Citizen option:

Please select the most appropriate response from the options provided.
With a Permanent U.S. Resident Visa:

Check this box if the candidate has been lawfully admitted for
permanent residence (i.e., is in the possession of a current and valid
Permanent Resident Card or other legal verification of such status).
A notarized statement will be required as part of the pre-award
process.
With a Temporary U.S. Visa:

Check this box if the candidate currently holds a temporary U.S
visa. This box is applicable only to specific programs that do not
require U.S. citizenship or permanent residency (e.g., K99/R00).
Not Residing in the U.S.:

Check this box if the candidate is a citizen of a country other
than the U.S. and plans to pursue career development
outside of the U.S. This box is applicable only to specific
programs (e.g., K43).
If you are a non-U.S. citizen with a temporary visa applying for an
award that requires per- manent residency status, and expect to
be granted a permanent resident visa by the start date of the
award, check here:

Check this box to indicate that permanent resident status is pending (i.e., if the
candidate is not a
U.S citizen but has applied for permanent residence and expects to
hold a permanent resident visa by the earliest possible start date of the

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award). A notarized statement will be required as a part of the preaward process. The statement must show that a licensed notary has
seen the career development applicant’s valid Permanent Resident
Card (USCIS Form I-551) or other valid verification from the U.S.
Immigration and Naturalization Service of legal admission to the U.S.

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