It is critical that applicants follow the Fellowship (F) instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The NIGMS Postdoctoral Research Associate Training (PRAT) Program’s overarching goal is to provide high quality postdoctoral research training in the basic biomedical sciences to a diverse group of postdoctoral fellows in NIH intramural research laboratories, and to prepare them for leadership positions in biomedical careers. Training includes a mentored research experience, and extensive career and professional development, mentoring, and networking opportunities planned and supported by the program. Fellows selected for the PRAT program receive three years of stipend support, benefits, and an annual travel and training allowance. More information on the NIGMS PRAT program can be found on the program website: https://www.nigms.nih.gov/Training/Pages/PRAT.aspx.

The first cohort of NIGMS PRAT fellows began their research training in the NIH Intramural Research Program in 1965, growing out of a desire to train more individuals in the field of pharmacology. Since then, numerous PRAT alumni have become leaders in their respective fields across multiple career sectors, and the program has broadened over time to support all research areas within the mission of NIGMS. The NIGMS PRAT program continues to provide access to excellent research, facilities, mentoring, and career development resources in the NIH Intramural Research Program and maintains a focus on training leaders in the basic biomedical sciences.

PRAT fellows conduct research in laboratories in the NIH Intramural Research Program in basic biomedical research areas that are within the NIGMS mission. These areas include but are not limited to biological chemistry, biophysics, bioinformatics, cellular and molecular biology, computational biosciences, developmental biology, genetics, immunology, neuroscience, pharmacology, physiology, and technology development. Fellows conduct their work with sponsors who have relevant experience in these areas of research in any of the NIH Institutes or Centers with an Intramural Research Program. Because the PRAT program regularly brings fellows together to participate in seminars and other activities, this arrangement allows fellows from a wide array of scientific disciplines to interact on a regular basis and to exchange ideas.

The NIGMS PRAT program distinguishes itself from other postdoctoral training opportunities on the NIH campus through its approach to cultivating the next generation of leaders in the basic biomedical sciences. The following principles guide the NIGMS PRAT program and its structured professional development curriculum:

• Leadership - As part of the bimonthly seminar series, PRAT fellows regularly meet with and learn from leaders in the biomedical research community and develop professional skills that will help them to smoothly transition into leadership roles (e.g., emotional intelligence, conflict resolution, negotiation). PRAT fellows plan a scientific symposium for the NIH campus during their final year in the program.
• Communication - The PRAT program offers regular opportunities to enhance oral and written communication skills through activities such as the seminar series in which fellows present their research, three-minute-talk training, grant writing workshops, and communications coaching.
• Networking - The fellows interact on a regular basis to present their research and exchange ideas during the seminar series combining a research presentation from a current PRAT fellow with a presentation from an outside speaker invited by the fellow. PRAT fellows receive an annual travel and training allowance which can be used to support travel to scientific meetings that broaden their networks. The fellows also engage with PRAT alumni through program events.
• Mentorship - In addition to their mentored research laboratory experience, PRAT fellows receive mentorship from the PRAT program director(s) and have the opportunity for additional mentorship from NIGMS scientific staff.
• Knowledge of Biomedical Research Enterprise - As part of the seminar series, fellows are exposed to the NIH grant making process through workshops on K-awards, peer review, and the various funding mechanisms available to support a biomedical research career.
• Diversity - Because diversity at all levels is integral to research and training excellence, PRAT fellows come from a wide variety of backgrounds (e.g., personal and scientific). Professional development focuses on developing skills to work effectively in teams with colleagues from a variety of cultural and scientific backgrounds, promoting inclusive and supportive scientific research environments, and communicating scientific research methodologies and findings to a wide variety of audiences (e.g., discipline-specific, across disciplines, and the public).
• Service - PRAT fellows have the opportunity and are expected to participate in service and outreach activities to the NIH (e.g. serving as the PRAT representative on the NIH Fellows Committee) or broader community (e.g. participate in NIGMS activities at the biennial USA Science and Engineering Festival, engaging with undergraduates who visit NIH as part of the annual NIGMS Director's Early-Career Investigator Lecture, etc.)

Fellows selected for the PRAT program are required to participate in the PRAT-sponsored training activities. The PRAT program director(s) oversees all activities of the NIGMS PRAT program.

NIGMS PRAT fellows are encouraged to broaden their training by attending scientific seminars on the NIH campus, traveling to scientific meetings, participating actively in lab meetings, making scientific presentations, and publishing the results of their research. Fellows receive formal training in the ethical conduct of research and scientific methods, including a focus on the reproducibility of data. Fellows are encouraged to take courses in quantitative biology and statistics if they have not already done so. Fellows are exposed broadly to the cutting-edge technologies for which the Intramural Research Program is noted. Fellows also have access to and are encouraged to utilize the resources of the NIH Office of Intramural Training and Education (OITE).

Each fellow's training plan should be explicitly designed to facilitate her/his transition to the next career stage and should explain how, in combination with the candidate's prior training and experience, it will contribute to the individual's career goals. It is expected that the mentored training experience will provide:

• A strong foundation in research design, methods, and analytic techniques appropriate to the proposed research;
• An enhanced ability to conceptualize and think through research problems with increasing independence;
• Experience conducting research using appropriate, state-of-the-art methods;
• The opportunity to present and publish research findings (including first authorship as appropriate) and to interact with members of the scientific community at scientific meetings and workshops;
• Professional and scientific skills needed to transition to the next stage of the applicant's research career; and
• Refinement of the applicant's understanding of the health-related sciences and the relationship of his/her research to health and disease.

The NIGMS encourages applications from individuals sufficiently early in their postdoctoral training period that they can benefit from the mentored research and training opportunities provided by the NIGMS PRAT program. This includes doctoral students who will complete their degree by the time of entrance into the program.

Note: This Funding Opportunity Announcement (FOA) does not allow applicants to propose to lead an independent clinical trial, clinical trial feasibility study, or an ancillary clinical trial.

See Section VIII. Other Information for award authorities and regulations.

NIH policies as described in the Office of Intramural Research Sourcebook and the NIH Policy Manual will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions

Governments

• Intramural Research Program of the NIH

Before submitting a fellowship application, the applicant must identify a sponsoring NIH Institute or Center. The application will be submitted by the sponsoring IC’s Authorized Organizational Representative (AOR) on behalf of the fellow. Fellows should plan for sufficient lead time in preparing the application to ensure the appropriate individual(s) for submitting the application is identified.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Graduate students/postdoctoral scientists applying for this fellowship will apply as the PD/PI - multiple PDs/PIs are not allowed. Any applicant fellow with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with her/his sponsor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

As this is a postdoctoral fellowship, eligible individuals must have completed a doctoral degree by the time of entrance into the program (doctoral students who will complete their degree by the time of entrance into the program are strongly encouraged to apply). In accordance with the policy of NIH Office of Intramural Research, individuals appointed to postdoctoral training positions using the Intramural Research Training Award (IRTA) must have no more than five years of relevant research experience since receipt of their most recent doctoral degree.

Additionally, individuals may only be supported on the IRTA mechanism for a maximum of 5 years, only 3 of which can be via the PRAT fellowship. Individuals currently in postdoctoral IRTA appointments in the NIH Intramural Research Program should plan to submit their applications early in their appointment so that they have accumulated no more than 24 months of training on the IRTA mechanism before entrance into the PRAT program. Below is a table of application due dates and the earliest date of entrance into the Intramural Research Program for which applicants are eligible to apply for the PRAT fellowship:

Application Due Date	Earliest IRTA start date eligible to apply
October 2, 2019	July 1, 2018 or after
October 2, 2020	July 1, 2019 or after
October 4, 2021	July 1, 2020 or after

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Individuals may receive up to 3 years of support from the NIGMS PRAT fellowship. Additional options are available to extend one's time in training in the NIH Intramural Research Program should this be needed at the completion of the PRAT program.

At the time of award, individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies.

Before submitting the application, the applicant must identify a sponsor(s) who will supervise the proposed mentored training experience. Applicants are encouraged to identify more than one sponsor, i.e., a sponsor team, if this is deemed advantageous for their training program. When there is a sponsor team, one individual must be identified as the primary sponsor, and will be expected to coordinate the applicant’s overall training. An NIH Intramural investigator is only allowed to serve as the primary sponsor on one PRAT application per review cycle but may co-sponsor additional applications. If multiple applications with the same primary sponsor are received in a single review cycle, all applications will be withdrawn.

The primary sponsor should be an active investigator in the area of the proposed research training and be committed to the applicant s research training, career development, and to direct supervision of the applicant's research. The primary sponsor must document the availability of sufficient research funds and facilities for high-quality research training. The primary sponsor, regardless of career stage, must describe how she/he will ensure that the fellow will receive the mentorship needed to advance their career. If the primary sponsor, or a member of the sponsor team, is a well-established investigator, she/he should have a successful track record of mentorship. The applicant must work with the primary sponsor in preparing the application.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Fellowship (F) instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Other Attachments: The application must include the following attachment.

Leadership Statement (1-page maximum)

The application must include a leadership statement from the PD/PI applying for a PRAT award (i.e., the postdoctoral fellow). Include a description of past leadership and service activities in the scientific community, or to enhance public engagement/understanding of scientific research. Include a description of commitment to diversity in the biomedical sciences, and your leadership, mentoring and outreach activities to enhance diversity especially involving groups underrepresented in the biomedical research enterprise. Describe planned activities during the fellowship to develop or enhance leadership skills (e.g. leading teams, skills to work effectively with scientists from a wide variety of backgrounds and promote inclusive and equitable scientific biomedical research environments, etc.).

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Biographical Sketch: Do not complete Section D "Research Support and/or Scholastic Performance."

The PHS Fellowship Supplemental Form is comprised of the following sections:

• Fellowship Applicant
• Research Training Plan
• Sponsor(s), Collaborator(s), and Consultant(s);
• Institutional Environment & Commitment to Training
• Other Research Training Plan Sections
• Additional Information
• Budget
• Appendix

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Training Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: In the Significance section: Describe the literature and preliminary data (collected by the applicant or others) that support the feasibility of the proposed project.

In the Approach section:

• Describe how the overall strategy, methodology, and analyses employ the highest standards of experimental design to ensure reproducible results (e.g., power analysis, consideration of relevant biological variables as appropriate, etc.).
• If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, describe the relationship of the proposed research project to the clinical trial.

Sponsor(s), Collaborator(s), and Consultant(s)

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

In Section C "Training Plan, Environment, Research Facilities": Sponsors and co-sponsors should describe how The Research Training Plan will facilitate the applicant's transition to the next stage of their career. Specifically, describe plans to ensure the fellow will receive the mentoring and other support needed for their career advancement. Additionally, the Sponsors and co-sponsors should describe efforts taken or planned to ensure the research environment is inclusive, and supports trainees from all backgrounds.

If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, the sponsor or co-sponsor must include a statement to document leadership of the clinical trial including source of funding, NCT# and appropriate expertise to guide the applicant in any proposed clinical trials research experience. The individual receiving support for the clinical trial (i.e., the sponsor/primary mentor or a co-sponsor) is the responsible individual of record for oversight of the trial though trainees and fellows can take part in all components of a clinical trial. Oversight includes (but is not limited to): interacting with relevant Institutional Review Board (IRB) staff; reviewing all informed consent documents; reporting potential serious adverse events; and maintaining responsibility for patient safety. However, the trainee or fellow can gain experience in all these components in conjunction with the mentor or individual leading the trial. The Sponsor should also describe the roles and responsibility that both he/she and the fellow are undertaking, including contributions to the research plan, the portion of the research ideas and plan that originated with the applicant, and the relationship between the proposed research plan and funded or unfunded research projects previously devised by the sponsor.

Budget

Tuition and Fees: Select the box labeled None Requested.

Appendix

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record. If gaining research experience in a clinical trial led by a sponsor/co-sponsor, provide the sponsor s ClinicalTrials.gov identifier (i.e., NCT number).

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

• Do not provide an NCT# in Section 1, item 1.5. See instruction for Sponsor(s), Collaborator(s), and Consultant(s) above.
• Do not complete Section 4 Protocol Synopsis information or Section 5 Other Clinical Trial-related Attachments.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Applicants must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. At least three, but no more than five, reference letters are required. The letters should be from individuals not directly involved in the application, but who are familiar with the applicant’s qualifications, training, and interests. The sponsor/co-sponsor(s) of the application cannot be counted toward the three required references. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Reference Letter link and not through Grants.gov.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All PRAT fellowship awards are subject to the terms and conditions, and other considerations described in the Office of Intramural Research Sourcebook and the NIH Policy Manual.

A PRAT fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this fellowship.

Pre-award costs are generally not allowable for Fellowships.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:
All PD(s)/PI(s) and sponsor(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the NIH Center for Scientific Review and the NIGMS Office of Scientific Review. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

• A fellowship application has a research project that is integrated with the training plan. The review will emphasize the applicant s potential for a productive biomedical research career, the applicant’s need for the proposed training, and the degree to which the research project and training plan, the sponsor(s), and the environment will satisfy those needs.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fellowship will enhance the applicant s potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the scored and additional review criteria.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Fellowship Applicant

• Are the applicant’s training record and research experience sufficient and appropriate for the proposed training plan?
• Does the applicant have the potential to develop into an independent and productive researcher?
• Does the applicant demonstrate commitment to a research career in the future?
• Does the research project reflect a significant contribution of the candidate to the originality of the project idea, approach, and/or hypotheses?
• Does the candidate show the potential to develop into a leader in the biomedical research community? Does the candidate describe a compelling commitment to diversity in the biomedical sciences, and robust plans to develop or enhance their leadership skills?

Sponsors, Collaborators, and Consultants

• Are the sponsor(s ) research qualifications (including recent publications) appropriate for the needs of the applicant?
• Do(es) the sponsor(s) describe robust plans to ensure the applicant receives the mentoring and support needed for their career advancement? For experienced investigators, are the sponsor(s ) track record of mentoring individuals at a similar stage appropriate for the needs of the applicant?
• Do(es) the sponsors have clear plans to facilitate the applicant's transition to the next stage of her/his career?
• Do(es) the sponsors describe sufficient efforts to ensure the research environment is inclusive, and supports trainees from all backgrounds?
• Is there evidence of a match between the research and clinical interests (if applicable) of the applicant and the sponsor(s)? Do(es) the sponsor(s) demonstrate an understanding of the applicant’s training needs as well as the ability and commitment to assist in meeting these needs?
• Is there evidence of adequate research funds to support the applicant’s proposed research project and training for the duration of the research component of the fellowship?
• If a team of sponsors is proposed, is the team structure well justified for the mentored training plan, and are the roles of the individual members appropriate and clearly defined?
• Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed project?
• If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, is there evidence of the appropriate expertise, experience, resources, and ability on the part of the sponsor(s) to guide the applicant during the clinical trial research experience?

Research Training Plan

• Is the proposed research project of high scientific quality, and is it well integrated with the proposed research training plan? Do the proposed the strategy, methodology, and analyses employ the highest standards of experimental design to ensure reproducible results?
• Do the literature cited and preliminary data (as appropriate for applicant's career stage) support the feasibility of the proposed research training plan?
• Based on the sponsor’s description of her/his active research program, is the applicant’s proposed research project sufficiently distinct from the sponsor’s funded research for the applicant’s career stage?
• Is the research project consistent with the applicant’s stage of research development?
• Is the proposed time frame feasible to accomplish the proposed training?
• Does the training plan provide adequate opportunities to present and publish research findings and meet with scientists in the community at national meetings as the work progresses?
• Will the training plan provide the professional skills needed for the applicant to transition to the next stage of his/her research career?
• If proposed, will the clinical trial experience contribute to the proposed project and/or the applicant’s research training?

Training Potential

• Are the proposed research project and training plan likely to provide the applicant with the requisite individualized and mentored experiences in order to obtain appropriate skills for a research career?
• Does the training plan take advantage of the applicant s strengths and address gaps in needed skills? Does the training plan document a clear need for, and value of, the proposed training?
• Does the proposed training have the potential to serve as a sound foundation that will clearly enhance the applicant’s ability to develop into a productive researcher?

Institutional Environment & Commitment to Training

• Are the research facilities, resources (e.g., equipment, laboratory space, computer time, subject populations), and training opportunities (e.g., seminars, workshops, professional development opportunities) adequate and appropriate?
• Is the institutional environment for the applicant’s scientific development of high quality?
• Is there appropriate institutional commitment to fostering the applicant’s mentored training?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Allowed

Revisions

Not Allowed

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for Instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - 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 - 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 - the role of the sponsor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIGMS Office of Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a committee process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to NIGMS. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by NIGMS. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Selected applicants will be notified by the PRAT program Director(s) and will receive a formal offer of a fellowship position sponsored by NIGMS for research to be conducted within the Intramural Research Program of the NIH. NIGMS PRAT Fellows are appointed using the Intramural Research Training Award (IRTA) mechanism. NIH policies as described in the Office of Intramural Research Sourcebook and the NIH Policy Manual will apply to all fellowships funded through this FOA.

Selected applicants will be appointed as NIGMS PRAT postdoctoral fellows in the NIH Intramural Research Program. PRAT fellows receive mentoring from the PRAT Director(s), and from Lab and Branch Chiefs in the Intramural Research Program. Additional information about the policies governing Intramural fellowship positions can be found in the NIH Policy Manual and Office of Intramural Research Sourcebook. More information about the design and purpose of the PRAT program can be found on the PRAT website.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

The taxability of stipends is described in the NIH Grants Policy Statement.

NIH policies as described in the Office of Intramural Research Sourcebook and the NIH Policy Manual will apply to all fellowships funded through this FOA.

Fellows will be required to submit an annual progress report. The NIGMS PRAT office maintains this form and ensures it is distributed to all fellows. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year.

NIH policies as described in the Office of Intramural Research Sourcebook and the NIH Policy Manual will apply to all fellowships funded through this FOA.

• Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

For programs involving postdoctorates and early career investigators:

• Subsequent participation in a formal research training or career development program in a STEM field
• Subsequent participation in research, employment or leadership in a STEM field
• Authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Desir e L. Salazar, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Peer Review Contact(s)

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Tony Moore
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. NIH policies as described in the Office of Intramural Research Sourcebook and the NIH Policy Manual will apply to all fellowships funded through this FOA.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 63A and 45 CFR Part 75.