PHS 398 Research Training Program Plan Instructions

G.420 - PHS 398 Research Training
Program Plan Form
The PHS 398 Research Training Program Plan Form is
used only for Training applications and Multi-project
applications with an "NRSA Training" Component.
This form includes fields to upload several attachments
including the Program Plan, Faculty Biosketches, and
Data Tables.
The attachments in this form, together with the rest of
your application, should include sufficient information
needed for evaluation of the training plan, 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)

Training Program Section
2. Program Plan
3. Plan for Instruction in the Responsible Conduct of Research
4. Plan for Instruction in Methods for Enhancing Reproducibility
5. Multiple PD/PI Leadership Plan (if applicable)
6. Progress Report (for Renewal applications)

Faculty, Trainees, and Training Record Section
7. Participating Faculty Biosketches
8. Letters of Support
9. Data Tables

Other Training Program Section
10. Vertebrate Animals
11. Select Agent Research
12. Consortium/Contractual Arrangements

Appendix

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13. Appendix

Who should use the PHS 398 Research Training Program Plan Form:
Use the PHS 398 Research Training Program Plan Form only if you are submitting a training application
or a multi-project application that has an "NRSA Training" Component.
Read all the instructions in the FOA before completing this section to ensure that your application
meets all IC-specific criteria.
Note on required tables: The instructions for the required Data Tables (1-8) are located on the NIH's
Data Tables page. Please read the “Introduction to Data Tables” before beginning to prepare your data
tables. The Introduction to Data Tables includes important definitions that should be used consistently
both in the "Data Tables" attachment of your application and in all other parts of the application. The
Data Tables must be included in the "Data Tables" attachment to avoid being counted against the
page limits of other attachments.
Note on non-required tables: Additional tables (i.e., those that are generated by the applicant or not
required by the FOA) should be identified by letter, rather than number, to avoid confusion with the
sequentially numbered required tables.
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. Note that page limits for the Introduction may differ based on the type of
application (i.e., resubmission or revision).
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 Revision Applications: 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.

Training Program Section
2. Program Plan
Who must complete the “Program Plan” attachment:
The “Program Plan” attachment is required.
Format:

Follow the page limits for the Program Plan in the NIH Table of Page Limits unless otherwise
specified in the FOA. The Program Plan (including sections "A. Background;" "B. Program Plan;"
and "C. Recruitment Plan to Enhance Diversity," when applicable) must fit within the Program Plan
page limit unless otherwise specified in the FOA.
Note that Data Tables may be referred to or summarized in this section; however, the actual
tables are not to be included in this attachment.
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:

Organize the Program Plan attachment in the specified order and use the instructions provided
below unless otherwise specified in the FOA. Start each section with the appropriate heading –
Background, Program Plan, and Recruitment Plan to Enhance Diversity. In addition, start each
subsection of the Program Plan with the appropriate subheading.
Check the FOA and the instructions for the Data Tables to determine which tables should be
included in the application and discussed in the Program Plan subsection.
A. Background

Provide the rationale for the proposed research training program, the relevant background
history, and the need for the proposed research training.
Indicate how the proposed program relates to current training activities at the applicant
institution.
Summarize the research training activities of the major participating unit(s) and department(s)
represented in the proposed program.

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If required, complete Tables 1-3 (these tables will be included in the Data Tables attachment), and
summarize the data here using the guidance below. In your narrative, refer to specific tables as
applicable.
Table 1. Census of Participating Departments and Interdepartmental Programs:
Describe the organization of the proposed training program, the participating departments
and interdepartmental programs, and the extent to which faculty, graduate students,
and/or postdoctorates from those departments/interdepartmental programs participate in
the programmatic activities to be supported by the training grant.
Table 2. Participating Faculty Members: Describe the distribution of participating faculty
by academic rank, department or interdepartmental program and areas of research
emphasis. Describe the rationale for the faculty selected to participate in the training grant.
Analyze the data in terms of the overall experience of the faculty in training predoctorates
and/or postdoctorates. Comment on the inclusion of faculty whose mentoring records may
suggest limited, recent training experience at either training level (predoctoral or
postdoctoral).
Table 3. Federal Institutional Research Training Grant and Related Support Available to
Participating Faculty Members: Summarize the level of research training support at the institution.
Comment on instances where the tabular data indicate that there may be substantial overlap of
participating faculty.
B. Program Plan

Note: Applicants for institutional career development awards (e.g., K12) must complete a
Research Career Development Program Plan instead of the Training Program Plan. Refer to
specific instructions in the FOA.
a. Program Administration

Program Director information: Describe the program director's qualifications for providing
leadership of the program, including relevant scientific background, current research areas, and
experience in research training. Indicate the program director's percent effort in the proposed
program.
Administrative information: Describe the administrative structure of the program and the
distribution of responsibilities within it, including the means by which the program director will
obtain continuing advice with respect to the operation of the program.
Special Instructions for Multiple PD/PI: If multiple PD/PIs are proposed, explain in this
section your rationale for how this will facilitate program administration. In addition, you must
complete the Multiple PD/PI Leadership Plan attachment in this form.
b. Program Faculty
Referring to the data presented in Table 2. Participating Faculty Members, describe each faculty
member's research that is relevant to the program and indicate how trainees will participate in
the research. Provide information on the extent to which participating faculty members have
cooperated, interacted, and collaborated in the past, including joint publications and joint
sponsorship of student research.
Use this section to document the ability of the faculty to support the research activities of the
proposed trainees, the training record of the participating faculty members, and the success of
their trainees in generating publishable research results. For any proposed participating faculty

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(i.e., program faculty) members lacking research training experience, describe a plan to ensure
that they will successfully guide trainees. Describe the criteria used to appoint and remove faculty
as program faculty and to evaluate their participation.
If required, complete Tables 4-5 (these Tables will be included in the Data Tables attachment),
and summarize the data here using the guidance below. In your narrative, refer to specific tables,
as applicable.
Table 4. Research Support of Participating Faculty Members: Analyze the data in terms of
total and average grant support. Additionally, comment on the inclusion of faculty without
research grant support and explain how the research of trainees who may work with these
faculty members would be supported.
Table 5A-C. Publications of Those in Training: Summarize these data, including, for
example, the average number of publications, and how many students have published their
work. For pre- and postdoctoral training programs, indicate how many trainees are
published as first author, and how many completed their doctoral or postdoctoral training
without any first-author publication.
Note for New Applications: List publications for students and/or postdoctorates who are
representative of those who would be appointed if the grant is awarded.
c. Proposed Training
Describe the proposed training program. Indicate the training level(s) and number of trainees,
the academic and research background needed to pursue the proposed training, and, as
appropriate, plans to accommodate differences in preparation among trainees. For postdoctoral
trainees, indicate the proposed distribution by degree (e.g., M.D., Ph.D.). Describe course work,
research opportunities and the extent to which trainees will participate directly in research,
activities designed to develop technical and/or professional skills, and the duration of training,
i.e., usual period of time required to complete the training offered.
Describe how the program and faculty will provide training in scientific reasoning, rigorous
research design, relevant experimental methods, relevant quantitative and data science
approaches, and data analysis and interpretation, appropriate to the level and prior preparation of
the trainees.
For multi-disciplinary and/or multi-departmental programs, indicate how the individual
disciplinary and/or departmental components of the program are integrated and coordinated
and how they will relate to an individual trainee's experience.
For training programs that emphasize research training for clinicians, describe the interactions
with basic science departments and scientists. Include plans for ensuring that the training of
these individuals will provide a substantive foundation for a competitive research career.
Generally, a minimum of 2 years of research training is expected for all postdoctoral trainees with
health professional degrees. Describe fully any trainee’s access to and responsibility for patients,
including time commitment.
Training programs that anticipate offering trainees opportunities to be involved in human
subjects research funded by other research grants may include a brief description of those
opportunities in this section, although such a description is not required.
Provide representative examples of programs for individual trainees. Include curricula, degree
requirements, didactic courses, laboratory experiences, qualifying examinations, and other
training activities, such as seminars, journal clubs, etc. Describe how the mentor and research
areas are chosen, how each trainee's program will be guided, and how the trainee's performance
will be monitored and evaluated. Include detailed mentoring plans as appropriate.
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d. Training Program Evaluation
Describe an evaluation plan to review and determine the quality and effectiveness of the training
program. This should include plans to obtain feedback from current and former trainees to help
identify weaknesses in the training program and to provide suggestions for program
improvements. Specified evaluation metrics should be tied to the goals of the program. In
addition, describe plans for assessing the career development and progression of trainees,
including publications, degree completion, and post-training positions.
Renewal Applications: Discuss evaluation results, and indicate whether the program has been
modified as a result.
e. Trainee Candidates
Describe, in general terms, the size and qualifications of the pool of trainee candidates, including
information about the types of prior clinical and research training and the career level required
for the program. Describe specific plans to recruit candidates and explain how these plans will be
implemented (see also "Section C. Recruitment Plan to Enhance Diversity" within the Program
Plan). Describe the nomination and selection process to be used to select candidates who will be
offered admission to the program and criteria for trainees’ reappointment to the program.
If required, complete Tables 6A and/or 6B (these Tables will be included in the Data Tables
attachment), and summarize the data here using the guidance below. In your narrative, refer to
specific tables as applicable.
Tables 6A and/or 6B. Applicants, Entrants, and their Characteristics for the Past Five Years
(Predoctoral and Postdoctoral). Summarize the data in terms of the overall numbers of potential
trainees, their credentials, their characteristics, their eligibility for support, and enrollment trends.
f. Institutional Environment and Commitment to Training
Include information in the application that documents the support and commitment of the
applicant organization and participating units and departments to the goals of the proposed
program. This could include, for example, space, shared laboratory facilities and equipment,
funds for curriculum development, release time for the PD/PI and participating faculty, support
for additional trainees in the program, or any other creative ways to improve the environment for
the establishment and growth of the research training program.
Include a signed letter, on institutional letterhead, that describes the applicant organization’s
commitment to the planned program (see instructions in the Letters of Support section).
Institutions with ongoing research training, student development, or career development
programs that receive external funding should explain what distinguishes the proposed program
from existing ones at the same trainee level; how the programs will synergize, if applicable;
whether trainees are expected to transition from one support program to another; and how the
training faculty, pool of potential trainees, and resources are sufficiently robust to support the
proposed program in addition to existing ones.
g. Qualifications of Trainee Candidates and Admissions and Completion Records
Describe the ability of the participating departments/programs to recruit and retain trainees
through the completion of their training, the selectivity of the admissions process, and the
success of the departments/programs in recruiting individuals from diverse backgrounds (see
also Section C. Recruitment Plan to Enhance Diversity within the Program Plan).

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Discuss the quality and depth of the applicant pools, including both training-grant eligible and
non-training-grant eligible individuals, the competitiveness of the program, and the
characteristics of current program participants, referring to the data in Tables 6A and/or 6B, as
applicable.
Use all of this information to justify the number of positions requested.
If required, complete Tables 7-8 (these Tables will be included in the Data Tables attachment) and
summarize the data using the guidance below. In your narrative, refer to specific tables as
applicable.
Table 7. Appointments to the Training Grant for Each Year of the Current Project Period: Describe
the utilization of awarded training positions. If any trainee positions were not filled, if any trainees
terminated early, or if the distribution of appointed positions differs from the distribution of
awarded positions, provide an explanation.
Table 8A-D. Program Outcomes: Referring to relevant components of Table 8 (e.g. 8A, 8B,
8C and/or 8D, as appropriate), describe how training positions are used (i.e., distribution by
mentor, year in program, years of support per trainee), and the success of the program in
achieving its training objectives. For those who have completed their training, describe the
extent of their current involvement in research, including research grant support received
subsequent to completion of the training program.
Renewal applications: Discuss the selectivity of appointments to the training grant, and if
any postdoctoral trainee with a health professional degree was appointed to a KirschsteinNRSA training grant for less than 2 years of research training, explain why.
C. Recruitment Plan to Enhance Diversity
Who must complete the “Recruitment Plan to Enhance Diversity:”
A Recruitment Plan to Enhance Diversity is required for all training grant activity codes except
T34, T36, U2R, and all D-series activity codes. All other applications without a Recruitment Plan to
Enhance Diversity will be considered incomplete and will not be reviewed.
Content:
History and Achievements
Describe efforts to recruit individuals from underrepresented groups, including Diversity
Groups A, B, and C, as potential candidates for the existing training program. Refer to the
NIH Grants Policy Statement, Section 11.3.3.4: Recruitment Plan to Enhance Diversity for the
descriptions of Diversity Groups. As applicable, refer to the data presented in Tables 6 and 7.
Use these data to document the program’s past record of recruiting trainees who are
underrepresented and to provide information on their support.
Proposed Plans

Describe steps to be taken during the proposed award period to identify and recruit
graduate students and postdoctorates from Diversity Groups A, B, and C. Refer to the NIH
Grants Policy Statement, Section 11.3.3.4: Recruitment Plan to Enhance Diversity for the
descriptions of Diversity Groups. Consider the success and/or failures of recruitment
strategies used in the past. In particular, describe the specific efforts to be undertaken by
the training program and how these might relate to the recruitment efforts of the medical
school, graduate school, and/or the university at large. In most cases, centralized
institutional efforts alone will not satisfy the requirement to recruit individuals from

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underrepresented groups, and training grant faculty are expected to be actively involved in
recruitment efforts.
New Applications: Include a description of plans to enhance recruitment, including the
strategies that will be used to enhance the recruitment of potential trainees from
underrepresented groups.
Renewal Applications: Include a detailed account of experiences in recruiting individuals from
underrepresented groups during the previous funding period, including successful and
unsuccessful recruitment strategies. Information should be included on how the proposed plan
reflects the program’s past experiences in recruiting individuals from underrepresented groups.
For more information:

Refer to the NIH Grants Policy Statement, Section 11.3.3.4: Recruitment Plan to Enhance Diversity.

3. Plan for Instruction in the Responsible Conduct of Research
Who must complete the “Plan for Instruction in the Responsible Conduct of Research”
attachment:
A “Plan for Instruction in the Responsible Conduct of Research (RCR)” attachment is required for
all training grant activity codes except T36, unless otherwise noted in the FOA. Applications
lacking a Plan for Instruction in RCR will not be reviewed.
Format:
Follow the page limits for the Plan for Instruction 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:
The plan must address the five required instructional components outlined in the NIH Policy on
Instruction in RCR, as more fully described in the NIH Grants Policy Statement, Section 11.3.3.5:
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.
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, and research ethics.
3. Faculty Participation: Describe the roles of mentor(s) and other faculty involvement in
the instruction.
4. Duration of Instruction: Describe the total number of contact hours of instruction.
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 must also describe how participation in RCR instruction will be monitored.

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Renewal Applications: Describe any changes in formal instruction over the past project period
and plans for the future that address any weaknesses in the current RCR instruction. All training
faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the
past project period must be named in the application.
For more information:
See the NIH Grants Policy Statement, Section 11.3.3.5: Training in the Responsible Conduct of
Research.

4. Plan for Instruction in Methods for Enhancing Reproducibility
Who must complete the “Plan for Instruction in Methods for Enhancing Reproducibility”
attachment:

A “Plan for Instruction in Methods for Enhancing Reproducibility” attachment is required for all
training grant activity codes except D71, unless otherwise noted in the FOA. Applications lacking
a Plan for Instruction in Methods for Enhancing Reproducibility will not be reviewed.
Format:

Follow the page limits for the Plan for Instruction in in Methods for Enhancing Reproducibility 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 must describe how trainees will be instructed in principles important for enhancing
research reproducibility. These principles include, at a minimum, the following:
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evaluation of the foundational research underlying a project (i.e., the rigor of the prior
research);
rigorous experimental design and data interpretation;
consideration of relevant biological variables such as sex;
authentication of key biological and/or chemical resources; and
transparency in reporting.

Include a description of how instructional strategies will be integrated into the overall training
program at multiple stages of trainee development and in a variety of formats and contexts.
Describe how program faculty will reiterate and augment key elements of methods for enhancing
reproducibility in the context of trainees’ research projects.

5. Multiple PD/PI Leadership Plan (if applicable)
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 leadership plan if you are not submitting a multiple PD/PI application.

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Additional Instructions for Multi-project:
Overall Component: The “Multiple PD/PI Leadership Plan” attachment is required only in
the Overall Component.
Format:

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

The emphasis in a training grant's Multiple PD/PI Leadership Plan should be on how multiple
PD/PIs will benefit the program and the trainees. A single PD/PI must be designated as Contact
PD/PI (in G.200 - SF 424 (R&R) Form, PD/PI Contact Information) for the purpose of
communicating with the NIH, although other individuals may contact the NIH on behalf of the
Contact PD/PI when necessary. Because training programs are intended to be coherent, NIH will
not allocate the budget or training positions between multiple PD/PIs. A single award will be
made. Multiple PD/PI plans should include reasonable numbers of PD/PIs and each should be
included for a specific and clearly stated purpose.
A rationale for choosing a multiple PD/PI approach should be described. The governance and
organizational structure of the leadership team and the training program should be described,
including communication plans, processes for making decisions, and procedures for resolving
conflicts. The roles and administrative, technical, and other responsibilities for the training
program should be delineated for the PD/PIs and other collaborators.
For more information:

For background information on the multiple-PD/PI initiative, see NIH's Multiple Principal
Investigators page.

6. Progress Report (for Renewal applications)
Who must complete the “Progress Report” attachment:

A “Progress Report” attachment is required only if the type of application is renewal.
Format:

Follow the page limits given below, unless otherwise specified in the FOA.
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:

Organize the Progress Report according to the specified sections. Start each section with the
appropriate heading – Program Overview or Progress of Those Appointed to the Grant.
Program Overview (Page limit: 5 pages)

Provide an overview of accomplishments and progress achieved in the period since the last
competitive review. Focus on elements specific to the training program (rather than on
opportunities generally available in the institution’s other departments or other programs).
Describe how the funds provided under Training Related Expenses were used to benefit the
program.
List any workshops or seminars sponsored by the program. Include the workshop/seminar titles,
speakers, and relevance to the theme and training objectives of the program.

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Indicate whether the training program uses Individual Development Plans (IDPs). If so, describe
how IDPs were used in this reporting period to help manage the trainees’/scholars’ training and
career development.
Note: Do not include actual IDPs or blank IDP forms.
Note for AHRQ trainees: Neither IDPs nor information about IDPs is required.
You may refer to information that is included elsewhere in the application, such as the Program
Plan or outcomes described in the Training Data Tables, but do not repeat that information in the
Progress Report.
Progress of Those Appointed to the Grant (Page limit: 1 page per appointee)

For each trainee or scholar appointed to the grant in the period covered since the last
competitive review, provide a summary of his or her training and progress, including the
following information, as applicable:
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Degrees working toward or received;
Mentor(s);
Description of the trainee/scholar’s research project and progress;
Career development activities (e.g., individualized coursework or workshops attended);
Conference presentations;
A description of the trainee’s contribution to any planned or published papers resulting
from research conducted while supported by this award (e.g., designed or conducted
experiment, analyzed data, drafted paper); and
Honors, awards, fellowships, and any other support received during the period of
training. Note: Support before and after the appointment is reported in the Data Tables
and should not be reported here.

Do not include the following, either in the Progress Report or elsewhere in the application
(including the Appendix), unless otherwise specified in the FOA:
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Biosketches of current or former trainees/scholars;
Any sensitive, personally identifiable information, such as photographs or any other
individual demographic information;
Actual IDPs or blank IDP forms;
Promotional material for workshops, seminars, or other events (flyers, agendas, etc.);
Course syllabi; and
Program brochures.

Applications that include any of these materials will be withdrawn and not reviewed.
Note: A My Bibliography report of publications arising from work conducted by trainees while
supported by the training grant is not required in the application. However, it will be collected in
the Interim Final Research Performance Progress Report.
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 the Other
Component, but do not attach the same information in multiple locations.

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Faculty, Trainees, and Training Record Section
7. Participating Faculty Biosketches
Format:

Combine all participating faculty biosketches into a single PDF and attach this information
here. Follow the attachment guidelines on NIH's Format Attachments page.
Content:

Faculty biosketches for participating faculty must follow the instructions for a
biographical sketch (refer to G.240 - Senior/Key Person Profile (Expanded) Form) with the
following exception: a personal statement, while encouraged, is not required.
Please note that the biosketches of the PD/PI and any other senior/key personnel (e.g.,
co- directors, if applicable, and program staff) should not be included here, but they
should instead be included in the G.240 - R&R Senior/Key Person Profile (Expanded)
Form.

8. 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 letters here from:
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Consultants, if applicable. Letters should include rate/charge for consulting
services and confirm their role(s) in the project.
Senior Administration Officials. This letter should be a signed letter on
institutional letterhead, and it should describe the applicant institution’s
commitment to the planned program.

A President, Provost, Dean, Department Chair, or other key institutional leader with
institution-wide responsibilities. This letter should be a signed letter on institutional
letterhead, and it should describe and acknowledge institutional commitment to the
following areas:
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Ensuring that proper policies, procedures, and oversight are in place to prevent
discriminatory harassment and other discriminatory practices;
Responding appropriately to allegations of discriminatory practices, including any
required notifications to the HHS Office of Civil Rights; and

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

Adopting and following institutional procedure for requesting NIH prior approval of a
change in the status of the Program Director/Principal Investigator (PD/PI) or other
senior/key personnel if administrative or disciplinary action is taken that impacts the
ability of the PD/PI or other key personnel to continue his/her role on the NIH award as
described in the training grant application.

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Check the FOA (particularly for non-NRSA programs) to determine whether any additional
program-specific letters of support are required.
For more information:
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NIH Guide Notice on Harassment and Discrimination Protections in NIH Training
Applications.
NIH Grants Policy Statement, Section 4.1.2: Civil Rights Protections.
NIH Grants Policy Statement, Section 8.1.2.6: Change in Status, Including Absence of PD/PI
and Other Senior/Key Personnel Named in the NoA.

9. Data Tables
Format:

The information provided in the required data tables (Data Tables 1-8 described below) will not
be counted toward the page limitation. These tables should be numbered consecutively and
titled as instructed. Start each numbered table on a new page.
Bookmark each table separately in the PDF attachment. Many PDF generators will automatically
create bookmarks from text formatted using predefined Heading styles in Word.

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Combine all Data Tables into a single PDF file and attach it here. See NIH's Format Attachments
page.
Content:

Instructions for Data Tables 1-8 are located on NIH's Data Tables page. These instructions
include an Introduction to the Data Tables that provides instructions applicable to all tables,
specific instructions for each table, and Sample Data Tables. The sample data tables illustrate the
kind of data to include in each table for training grant applications.
If not using the Extramural Trainee Reporting and Career Tracking (xTRACT) system to prepare
data tables, be sure to choose the Instruction and Blank Data Table set that correspond to both
the type of application you are submitting (e.g., new application, renewal or revision application)
and the kind of training to be provided (e.g., predoctoral only, postdoctoral only, pre and
postdoctoral mixed, etc.).

Other Training Program Section
10. 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 the Vertebrate Animals attachment to circumvent the page limits of the Program Plan.
Content:
Trainee Participation Only in Research Involving Vertebrate Animals that is Part of Other Research
Project Grants: Describe how the institution will ensure that trainees participate only in IACUCapproved vertebrate animal research if the following two conditions apply:
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the training program uses live vertebrate animals only as part of other research project
grants, and
the training grant does not support the purchase, use, or husbandry of live vertebrate
animals.

Independent Trainee Research Involving Vertebrate Animals: In training programs where trainees will
design and conduct their own independent vertebrate animal research, follow the instructions below:
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 “Program Plan”
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.

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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 three 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.

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
NIH Grants Policy Statement, Section 4.1.1: Animal Welfare Requirement (an applicable Animal
Welfare Assurance will be required if the grantee institution does not have one)

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

Include a “Select Agent Research” attachment if the proposed training activities will 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 of
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:

If participating faculty proposed in the training program are conducting or plan to conduct
research involving select agents in which trainees may participate, follow the instructions below.
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, 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

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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.
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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.

12. Consortium/Contractual Arrangements
Who must complete the “Consortium/Contractual Arrangements” attachment:
Include the “Consortium/Contractual Arrangement” 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 on the G.200 - SF 424 (R&R)
Form, 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.

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For more information:

Refer to the NIH Grants Policy Statement, Section 15: Consortium Agreements for more
information.

Appendix
13. 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 appendix
attachments are needed, combine the remaining information into attachment #10.
As a reminder, tables other than the required Data Tables 1-8 must be incorporated into the
Program Plan (and will count toward the Program Plan’s page limits), and must not be included in
the Appendix. Follow the page limits for Institutional Training Grants specified in the NIH Table of
Page Limits, unless otherwise specified in the FOA.
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.

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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:
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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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