SF 424 (R&R) Cover Page

1. Type of Submission

Select the appropriate option

2. Date Submitted

(Leave Blank)

2. Applicant Identifier

Last, First F31 KR [record number]

Example: Lapek, Jeniffer F31 KR 12345

3. Date Received by State and State Application Identifier

(Leave Blank)

4a. Federal Identifier

Resubmissions only: enter grant number (institute code and serial number only; Example: CA654321).

4b. Agency Routing Identifier

(Leave Blank)

4c. Previous Tracking Identifier

(Leave Blank)

5. Applicant Information

UEI: UYTTZT6G9DT1

Legal Name: The Regents of the Univ. of Calif., U.C. San Diego

Department: Office of Contract and Grant Administration

Division: General Campus

Street 1: 9500 Gilman Drive

Street 2: MC 0934

City: La Jolla

State: California

ZIP / Postal Code: 92093-0934

Country: United States

Person to be contacted on matters involving this application
First Name: Michael

Last Name: Kusiak

Position: Director, Office of Contract & Grant Admin

Address: same as above

Phone Number: 858-534-3330

Fax Number: 858-534-0280

Email: researchadmin@ucsd.edu

6. Employer Identification (EIN) or (TIN)

1​9​5​6​0​0​6​1​4​4​A​1​

7. Type of Applicant

H: Public/State Controlled Institution of Higher Education

8. Type of Application

Check “New” if this is your first time submitting to NIH or first time submitting this project to NIH.
Check “Resubmission” if you are submitting this application to NIH for the second time.

9. Name of Federal Agency

National Institutes of Health

10. Catalog of Federal Domestic Assistance Number

(Leave Blank)

11. Descriptive Title of Applicant's Project

200 characters max

Enter your project title

12. Proposed Project

These are the earliest possible standard start dates for each cycle of NIH. If you are applying for:

Cycle 1 (Apr)

December 1

Cycle 2 (Aug)

April 1 of next year

Cycle 3 (Dec)

July 1 of next year

13. Congressional District of Applicant

CA-050

14. PD/PI Contact Information

This information populates from the Sr/Key Person tab.
To change this information, update the Sr/Key Person tab.

15. Estimated Project Funding

Lines A and C: Total Costs (see KB0034041)

Lines B and C: (Leave Blank)

16. Is Application subject to review by State Executive Order 12372 process?

Check “No” (This program is not covered by E.O. 12372).

17. Certification

Check "I agree" to provide the required certifications and assurances.

18. SFLLL or Other Explanatory Documentation

Do not attach anything to this line.

19. Authorized Representative

SIO Applicants: contact your fund manager for this information

First Name: Jeniffer ← watch the nonstandard spelling: one N and two Fs

Last Name: Lapek

Position/Title: Senior Contract & Grant Officer

Name of Organization: The Regents of the Univ. of Calif., U.C. San Diego

Department: Office of Contract & Grant Administration

Division: General Campus

Street 1: 9500 Gilman Drive

Street 2: MC 0934

City: La Jolla

County: San Diego

State: California

Country: United States

ZIP / Postal Code: 92093-0934

Phone Number: 858-534-3330

Fax Number: 858-534-0280

Email: jmlapek@ucsd.edu

20. Pre-Application

Do not attach anything to this line.

21. Cover Letter

Content Guidelines: Address cover letter to the Division of Receipt and Referral and include:

• Application Title
• NOFO Number (see above)
• List of Referees (including name, departmental affiliation, and institution)
• Statement that you have attached any required documentation for the type of application submitted.
• Additional statements are required if the proposed studies will generate large-scale human or non-human genomic data or involve human fetal tissue obtained from elective abortions (HFT).

The Cover Letter attachment may not be used to communicate application assignment preferences. Instead, use the Assignment Request Form. To add the form, click Add Optional Form from the Actions panel on the left side of the ASSIST application, select Assignment Request form, and click Submit. The form will appear as a new tab in the ASSIST application. For more detailed instructions, see G.600, Assignment Request Form.

Other Project Information Form

1. Are Human Subjects Involved?

Not sure if your application requires Human Subjects approval? Use NIH’s Decision Tool.

If YES to Human Subjects and EXEMPT from federal regulations, select the appropriate exemption number.

If YES to Human Subjects and NOT EXEMPT from federal regulations, then the answer to "If NO, is the IRB review Pending?" should also be YES.

IRB Approval Date: Leave Blank

Human Subject Assurance Number: 00004495

If you will be using human subjects in your project, you will need to include a PHS Enrollment Inclusion Form. To add the form, click Add Optional Form from the Actions panel on the left side of the ASSIST application, select PHS Enrollment Inclusion Form, and click Submit. The form will appear as a new tab in the ASSIST application.

2. Are Vertebrate Animals Used?

If YES, then the answer to "Is the IACUC review Pending?" should also be YES.

IACUC Approval Date: Leave Blank

Animal Assurance Welfare Number: D16-00020

3. Is proprietary/privileged information included in the application?

If your application contains patentable ideas/trade secrets (note: this is very rare), check YES and make sure that the proposal is marked appropriately.

4. Does this project have an actual or potential impact - positive or negative - on the environment?

For most proposals, the answer to this is usually NO.

5. Is the research performance site designated, or eligible to be designated, as a historic place?

For most proposals, the answer to this is usually NO.

6. Does this project involve activities outside of the United States or partnerships with international collaborators?

For most proposals, the answer to this is usually NO.

7. Project Summary/Abstract

30 lines of text max

Content Guidelines: key focus, long-term goals, relevance to agency’s mission, research design methods. Write in third person. Don’t describe past accomplishments.

8. Project Narrative

3 sentences max

Content Guidelines: Describe the relevance of this research to public health in, at most, three sentences. What will your research contribute to the field?

9. Bibliography & References Cited

No page limit

Content Guidelines: All citation formats are acceptable.

10. Facilities & Other Resources

No page limit

Content Guidelines: Describe how the research site contributes to the probability of success, like, institutional support, physical resources, and intellectual rapport.

Not required but can help establish the feasibility of the project

11. Equipment

No page limit

Content Guidelines: List major items of equipment already available for the project and, if possible, where it is and what it can do.

Not required but can help establish the feasibility of the project

Senior/Key Person Profile Form

Project Director/Principal Investigator Profile

Credential, e.g., agency login: Your eRA Commons ID The system will not submit the application without it!

First Name: Your first name

Last Name: Your last name

Position/Title: Graduate Student Researcher

Department: Your home department

Division: Enter School of Medicine, Skaggs, General Campus, or Scripps Inst. of Oceanography

Street 1: 9500 Gilman Drive 

Street 2: MC: XXXX ← your home department mail code

City: La Jolla

County/Parish: San Diego 

State: California

Zip/Postal Code: 92093-XXXX ← your home department mail code

Phone Number: Your personal phone number

Email: Your email address

Project Role: PD/PI

Degree Type: Enter highest degree received (DO NOT enter PhD)

Degree Year: Enter the year that the highest degree was received

Biographical Sketch (5 Pages Max): Make sure to use the current format page (fellowship) and follow current content guidelines. For Section D, List all undergraduate and graduate courses by institution and year, with grades. Explain any grading system used if it differs from a 1-100 scale; an A, B, C, D, F system; or a 0-4.0 scale.

Current & Pending Support: Do not attach anything to this line.

Senior/Key Person Profile

Follow these instructions for each mentor (Sponsor), co-mentor (Co-Sponsor), consultant, or other significant contributor

Enter faculty’s eRA Commons ID in the Credential, e.g., agency login field and then click Populate fields from Credentials. This will autofill whichever fields the PI has completed on their profile. Complete missing fields as follows and/or ask faculty member:

Position/Title: Faculty’s title as it appears on Blink

Department: Faculty’s home department

Division: Enter School of Medicine, Skaggs, General Campus, or Scripps Inst. of Oceanography

Street 1: 9500 Gilman Drive 

Street 2: MC: XXXX ← faculty’s home department mail code

City: La Jolla

County/Parish: San Diego 

State: California

Zip/Postal Code: 92093-XXXX ← faculty’s home department mail code

Project Role: Other (Specify)

Other Project Role Category: Sponsor, Co-Sponsor, Consultant, or Other Significant Contributor (do not write Mentor)

Biographical Sketch (5 Pages Max): Make sure to use the current format page (non-fellowship) and follow current content guidelines.

Current & Pending Support: Do not attach anything to this line.

Fellowship Supplemental Form

1. Introduction (Resubmissions only)

1 page max

Required for resubmission applications (see Resubmission Applications). Otherwise, do not attach anything on this line. 

2. Applicant’s Background and Goals for Fellowship Training

6 pages max

Content Guidance: Organize your background and goals in the specified order using the following subsection titles:

A. Doctoral Dissertation and Research Experience

• Briefly summarize your past research experience, results, and conclusions, and describe how that experience relates to the proposed fellowship. In some cases, a proposed fellowship may build directly on previous research experiences, results, and conclusions. In other situations, past research experiences may lead a candidate to apply for a fellowship in a new or different area of research. Do not list academic courses in this section.
• Applicants with no research experience: Describe any other scientific experiences.
• Advanced graduate students (i.e., those who have or will have completed their comprehensive examinations by the time of award): Include a narrative of your planned doctoral dissertation (may be preliminary).

B. Training Goals and Objectives

• Describe your overall training goals for the duration of the fellowship and how the proposed fellowship will enable the attainment of these goals. 
• Identify the skills, theories, conceptual approaches, etc., to be learned or enhanced during the award, including, as applicable, expertise in rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation, as applicable. 
• Discuss how the proposed research will facilitate your transition to the next career stage

C. Activities Planned Under this Award

• Briefly summarize your past research experience, results, and conclusions, and describe how that experience relates to the proposed fellowship. In some cases, a proposed fellowship may build directly on previous research experiences, results, and conclusions. In other situations, past research experiences may lead a candidate to apply for a fellowship in a new or different area of research. Do not list academic courses in this section.
• Applicants with no research experience: Describe any other scientific experiences.
• Advanced graduate students (i.e., those who have or will have completed their comprehensive examinations by the time of award): Include a narrative of your planned doctoral dissertation (may be preliminary).

3. Specific Aims

1 page max

Content Guidance: State concisely the goals and expected outcome(s), including the impacts of the research proposed. List succinctly the specific objectives of the research proposed.

4. Research Strategy

6 pages max

Tip 1: If possible, keep section to a max of 5.5 pages, your reviewer will appreciate it.

Tip 2: Try to include experts in your field of research who might review your application 

Content Guidance: Organize your research strategy in the specified order using the following subsection titles:

Significance

• Explain the importance of the problem or critical barrier to progress that the proposed project addresses.
• Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
• Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

Approach

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

As applicable, also include the following information as part of the Research Strategy, keeping within the two sections (Significance and Approach) listed above.

• Preliminary Studies for New Applications: For new applications, include information on preliminary studies (including data collected by others in the lab), if any. Discuss the applicant's preliminary studies, data, and/or experience pertinent to this application.

5. Respective Contributions

1 page max

Content Guidance: Describe the collaborative process between you and your sponsor/co-sponsor(s) in the development, review, and editing of this Research Training Plan. Also discuss your respective goals in accomplishing the proposed research.

6. Selection of Sponsor and Institution

1 page max

Content Guidance: Explain why you picked your sponsor and why you are doing research on campus. If you aren’t doing research on campus, explain here.

Foreign Institution: If you are proposing a research training experience at a foreign institution, describe how the foreign institution and sponsor offer special opportunities for training that are not currently available in the United States 

7. Progress Report Publication List (Renewals only)

Do not attach anything to this line.

8. Training in the Responsible Conduct of Research

1 page max

Content Guidance: The plan must address the following five instructional components using the following subsection titles:

• 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.
• 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).
• Faculty Participation: Describe the role of the sponsor/mentor(s) and other faculty involvement in the instruction.
• Duration of Instruction: Describe the total number of contact hours of instruction, taking into consideration the duration of the program.
• 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.

9. Sponsor and Co-Sponsor Statements

6 pages max

Content Guidance: Each sponsor and co-sponsor statement must address all of the following sections (A-E).

1. Research Support Available
2. Sponsor's/Co-Sponsor's Previous Fellows/Trainees
3. Training Plan, Environment, Research Facilities
4. Number of Fellows/Trainees to be Supervised During the Fellowship
5. Applicant's Qualifications and Potential for a Research Career

10. Letters of Support from Collaborators, Contributors, and Consultants

6 pages max

If any collaborators, consultants, or advisors will make contributions to your project/ research training, attach letters of support from them here, describing their role and contributions. 

Note that these are different from Reference Letters, which are letters of recommendation sent directly to NIH via eRA Commons

11. Description of Institutional Environment and Commitment to Training

2 pages max

Content Guidance: Include the grad program you are currently enrolled in, description of program and structure, required milestones and usual timing, number of courses, teaching commitments, qualifying exams, journal clubs, seminars, clinical requirements, average time to complete the degree over the last 10 years. Indicate the facilities and other resources that will be made available for both career enhancement and the research proposed in this application. Where are you in the timeline of the program discussed above? How are you evaluated and monitored?

Include the name of the person who gave you the information (usually department chair or program coordinator/director).

12. Description of Candidate’s Contribution to Program Goals

Diversity only. Otherwise, not required, do not include.

The sponsoring institution must provide a document on institutional letterhead that explains how the candidate’s participation will further the goals of the fellowship program to promote diversity in health-related research.

For NIH’s Interest in Diversity, see the Notice of NIH's Interest in Diversity.

The attachment must be dated and signed by the department chair..

13. Vertebrate Animals

If you have answered "No" for activities involving vertebrate animals and activities involving vertebrate animals are not planned at any time during the proposed project at any performance site, then skip 13 and 14.

If you have answered "Yes" for activities involving vertebrate animals: complete Line 13 and prepare the Vertebrate Animals attachment for 14 in consultation with your Sponsor.

14. Vertebrate Animals (Attachment)

No page limit

Content Guidance: Subsection titles should match the application guide:

1. Description of Procedures
2. Justifications
3. Minimization of Pain and Distress

15. Select Agent Research

No page limit

Only required if applicable. For guidance, refer to the NIH application guide.

16. Resource Sharing Plan

No page limit

Only required if applicable. For guidance, refer to the NIH application guide.

17. Other Plan(s)

No page limit 

Do not attach anything to this line.

18. Authentication of Key Biological and/or Chemical Resources

No page limit

Only required if applicable. For guidance, refer to the NIH application guide.

19. Human Embryonic Stem Cells

Required. For guidance, refer to the NIH application guide.

20. Alternate Phone Number

Optional.

21. Degree Sought During Proposed Award

Select “PHD: Doctor of Philosophy”

22. Field of Training for Current Proposal

Required. For guidance, refer to the NIH application guide. 

23. Current or Prior Kirschstein-NRSA Support?

Required. For guidance, refer to the NIH application guide.

24. Applications for Concurrent Support

Required. For guidance, refer to the NIH application guide.

25. Citizenship

Required.

26. Change of Sponsoring Institution

Required. For guidance, refer to the NIH application guide.

27. Tuition and Fees

Check the "Funds Requested" box and enter the estimated costs of tuition/fees per year. Follow the guidance in KB0034041 in consultation with your fund manager/research administrator.

28. Childcare Costs

Indicate whether funds are being requested for childcare costs by checking the appropriate box ("None Requested" or "Funds Requested"). Applicants are eligible to receive $2,500 per year for childcare provided by a licensed childcare provider.

29. Present Institutional Base Salary

(Leave Blank)

30. Stipends/Salary During First Year of Proposed Fellowship

(Leave Blank)

31. Appendix

Do not attach anything to this line.

PHS Human Subjects and Clinical Trials Information

Required for all projects that include human subjects and/or clinical trials.

For guidance, refer to the NIH application guide.