SF424 R&R Form Set Instructions- NIH Proposals

1

Type of Submission

Select “Application” unless this is a Correction from a previous Grants.gov submission.

2

Date Submitted / Applicant Identifier

Leave Blank

3

Date Received by State / State Application Identifier

Leave Blank

4

Federal Identifier

Leave Blank, unless the Type of Submission is “Changed/Corrected,”  then enter the Grants.gov confirmation number from the previous submission.

5

Applicant Information

Address information for the University of Arizona.  The address and DUNS number are on the Quick Reference.  For the “person to be contacted” enter Sherry Esham’s information.

6

Employer Identification

1742652689A1, also found in the Quick Reference.

7

Type of Applicant

H:  Public/State Controlled Institution of Higher Ed

8

Type of Application

Select "New" if this application is being submitted to an agency for the first time.

Select "Resubmission" if this application was previously submitted, but not funded, and is being resubmitted for new consideration.

Select "Renewal" if this application is a competing renewal.

9

Name of Federal Agency

Pre-filled.

Application submitted to other agencies?

Enter the names of the other agencies if the answer is “yes”

10

Catalog of Federal Domestic Assistance Number / Title

If these fields are blank, leave them blank.  They will pre-fill only in some cases. 

11

Descriptive Title

Enter the title of the project

12

Areas Affected by the Project

Enter the cities, counties, states, countries affected by the proposed project

13

Start / Ending Date

Enter the start & end date of the project.  These can be edited later, if necessary.

14

Congressional Districts

Applicant:  AZ-007

Project:  Enter the legislative districts where the project will take place.  Visit http://www.census.gov/geo/www/cd109th/tables109.html to locate legislative districts. 

For outside the US, enter 00-000
For the entire US, enter US-ALL
For an entire state, enter the state abbreviation, then “All”, i.e., CA-ALL
Page 2 of the SF424 R&R has a place to upload a PDF file if you have a long list of districts.

15

Proj Dir/PI

Enter the PI’s name & contact information. 

16

Estimated Project Funding

1. Total project funding (the amount you are requesting from the sponsor
2. Total Fed & Non-Fed Funds:  the total requested from the sponsor, plus cost sharing
3. Estimated Program Income

These items do not import from the budget.

17

EO 12372 Process

Select NO (either answer will suffice)

18

I agree

This box must be checked prior to submission

19

Authorized Representative

Enter the information for Dr. Leslie Tolbert (see the Quick Reference)

20

Pre-Application

Rare for NIH proposals.  Attach the PDF file if a pre-proposal existed for this application.

21.

List of Additional Congressional Districts

Attach a PDF file listing congressional districts if you need more space than provided in section 14.

Profile Information

For the PI, information will import from the SF424 R&R cover page, and cannot be edited from the Sr/Key Person page.  For all other Sr/Key Personnel, enter the name & profile information as indicated

Credential

This is REQUIRED for the PI.  Enter the PI’s Commons Username.  This is the #1 submission error – don’t forget!  Call SPS if the PI doesn’t have a Commons Username.  This is not required for other Sr/Key Personnel, unless you are using the “Multiple PI” option, in which case the Commons Username must be listed for each PD/PI.

Project Role

Select one from the Drop-Down menu for each Sr/Key person profile.  If more than one person is named as PD/PI, the Multiple PI leadership plan is required (see Research Plan form).

Other Project Role Category

Fill in only if Project Role is “other”

Attach Biographical Sketch

Attach a PDF file for each person, in their profile box.  You may use the NIH Bio Sketch format, just strip the file of headers/footers.  4-page limit.

Attach Current and Pending Support

Do not attach a file here, unless it is required by the NIH program announcement.

Previous/Next Person

Use these buttons to navigate between previous and future entries. 

Select to attach additional Sr/Key Person forms

Becomes active once you’ve entered 8 (PI + 7) Sr/Key persons.  This allows you to extract the “Sr/Key Person” form and complete it (and attach it) for each additional person. Additional spaces for bio sketch attachments will be provided.

1

Human Subjects

Select Yes or No

1a

If YES to Human Subjects

Enter the remaining information in 1a

2

Vertebrate Animals

Select Yes or No

2a

If YES to Vertebrate Animals

Enter the remaining information in 2a

3

Proprietary/Privileged Information

Select Yes or No

4a

Environmental Impact

Select Yes or No

4b

If YES to 4a

Enter explanation

4c

EA or EIS

Select Yes or No if 4a is YES

4d

Explain

If YES to 4c, enter explanation

5a

Activities outside US or International Collaboration

Select Yes or No

5b

If Yes, Identify Countries

Enter the names of the countries, if 5a is YES

5c

Optional Explanation

6

Project Summary/Abstract

Attach a PDF file of the project abstract. 

7

Project Narrative

For NIH proposals, attach a PDF file that lists the “relevance” section of the abstract.

8

Bibliography & References Cited

Attach a Literature Cited PDF, if any

9

Facilities and Other Resources

Attach a PDF file listing facilities/other resources, if any

10

Equipment

Attach a PDF file listing equipment resources, if any

11

Other Attachments

Attach PDF files in accordance with the program announcement, if any.

1. PD/PI

This information imports from the SF424 R&R cover page.

New Investigator?

Select Yes or No

Degrees

Enter the PI’s degrees

2.  Human Subjects

If Human Subjects are on the project, Select Yes or No to indicate if the project is a clinical trial.

Agency-Defined Phase III Clin Trial?

If the answer to #2 is Yes, you must answer this question.

3.  Applicant Organization Contact

Information imports from the SF424 R&R cover page (section 5).

4. Human Embryonic Stem Cells?

Select Yes or No

If the answer is Yes, indicate the cell line(s), or check the box indicating that one from the registry will be used.

Instructions

1. Introduction to Application (for Resubmission or Revision only)

Use only if you are submitting an R&R Resubmission or Revision (Cover Page Item 8).

2. Specific Aims

List the broad, long-term objectives and the goal of the specific research proposed, for example, to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology.

3. Research Strategy

Organize the Research Strategy in the specified order and using the instructions provided below. Start each section with the appropriate section heading – Significance, Innovation, Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section

• Significance
  • Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.
  • 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.
• Innovation
  • Explain how the application challenges and seeks to shift current research or clinical practice paradigms.
  • Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions.
  • Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions.
• Approach

4. Inclusion Enrollment Report

If the renewal or revision application involves clinical research, then you must report on the enrollment of research subjects and their distribution by ethnicity/race and sex/gender.

5. Progress Report Publication List

List the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively. For publicly available citations, URLs or PMC submission identification numbers may accompany the full reference. Note copies of these publications are no longer accepted as appendix material.
As part of the Appendix material you may include only up to 3 of the following types of publications:

1. • Manuscripts and/or abstracts accepted for publication but not yet published: The entire article should be submitted as a PDF attachment.
2. • Manuscripts and/or abstracts published, but a free, online, publicly available journal link is not available: The entire article should be submitted as a PDF attachment.
3. • Patents directly relevant to the project: The entire document should be submitted as a PDF attachment.

(Do not include unpublished theses, or abstracts/manuscripts submitted (but not yet accepted) for publication.)
Note, publications and/or abstracts in press should no longer be included in the appendix material. Include the URL or PMC submission identification numbers along with the full reference in the Bibliography and References cited section, the Progress Report Publication List section, and/or the Biographical Sketch section.

Instructions

6. Protection of Human Subjects

This section covers only the initial information regarding the Protection of Human Subjects. See separate sections below for other human subjects related sections that may apply. Unless an explanation is necessary, if Human Subjects research is not involved, and you have checked the box marked “No” on the Other Project Information Component, you need not include any additional information in this section.

7. Inclusion of Women and Minorities

To determine if Inclusion of Women and Minorities applies to this application, follow the instructions in Part II of the Application Guide, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan.

8. Targeted/Planned Enrollment Table

If this application involves the Inclusion of Women and Minorities, complete the Targeted/Planned Enrollment Table.

9. Inclusion of Children

To determine if Inclusion of Children applies to this application, follow the instructions in the Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan.

Instructions

10. Vertebrate Animals

If you indicated that Vertebrate Animals are involved in this project, address the following five key points. In addition, when research involving vertebrate animals will take place at collaborating site(s) or other performance site(s), provide this information before discussing the five points. Although no specific page limitation applies to this section of the application, be succinct.
1. Provide a detailed description of the proposed use of the animals in the work outlined in the Research Design and Methods section. Identify the species, strains, ages, sex, and numbers of animals to be used in the proposed work.
2. Justify the use of animals, the choice of species, and the numbers to be used. If animals are in short supply, costly, or to be used in large numbers, provide an additional rationale for their selection and numbers.
3. Provide information on the veterinary care of the animals involved.
4. Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain, and injury.
5. Describe any method of euthanasia to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Medical Association. If not, present a justification for not following the recommendations.

For those applicants familiar with the PHS398, please note that the Literature Cited section of the Research Plan is now captured as “Bibliography & References Cited.” Refer to Item 8 in the Other Project Information Component for instructions.

11. Select Agent Research

Select Agents are hazardous biological agents and toxins that have been identified by HHS or 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. CDC maintains a list of these agents. See  http://www.cdc.gov/od/sap/docs/salist.pdf.
If the activities proposed in your application involve only the use of a strain(s) of Select Agents which has been excluded from the list of select agents and toxins as per 42 CFR 73.4(f)(5), the Select Agent requirements do not apply. Use this section to identify the strain(s) of the Select Agent that will be used and note that it has been excluded from this list. The CDC maintains a list of exclusions at http://www.cdc.gov/od/sap/sap/exclusion.htm.
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.
If any of the activities proposed in your application involve the use of Select Agents at any time during the proposed project period, either at the applicant organization or at any other performance site, 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.

1. • 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.

1. • Describe the procedures that will be used to monitor possession, use and transfer of Select Agent(s).
2. • Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

If you are responding to a specific funding opportunity announcement (e.g., PA or RFA), address any requirements specified by the solicitation.
Reviewers will assess the information provided in this Section, and any questions associated with Select Agent research will need to be addressed prior to award.

12. Multiple PD/PI Leadership Plan

For applications designating multiple PDs/PIs, a leadership plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Grant Award.

13. Consortium/Contractual Arrangements

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. The signature of the authorized organizational official on the SF424 (R&R) cover component (Item 18) 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. A separate statement is no longer required.

14. Letters of Support

Attach appropriate letters here from all individuals confirming their roles in the project and rate/charge for consulting services.

15. Resource Sharing Plan(s)

This section includes Data Sharing Plan, when applicable, and Sharing Model Organisms. These descriptions are not included in the Research Plan page limits.
1) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Specific funding opportunity announcements may also require that all applications include this information regardless of the dollar level. Applicants are encouraged to read the specific opportunity carefully and discuss their data-sharing plan with their program contact at the time they negotiate an agreement with the Institute/Center (IC) staff to accept assignment of their application.
(2) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are to include a description of a specific plan for sharing and distributing unique model organism research resources or state appropriate reasons why such sharing is restricted or not possible. Note unlike the data sharing requirement above, this requirement is for all applications where the development of model organisms is anticipated. See Sharing Model Organisms Policy. If model organisms are not planned as part of the research proposal, omit this section.

18. Appendix

Only one copy of appendix material is necessary. Use filenames for these attachments that are descriptive of the content. Use the add attachments button to the right of this field to complete this entry. A maximum of 10 PDF attachments is allowed. If more than 10 are needed, combine the remaining information into attachment #10. 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 as the first appendix attachment.
New, resubmission, renewal, and revision applications may include the following materials in the Appendix:

1. • Publications – No longer allowed as appendix materials except in the circumstances noted below. Applicants may submit up to 3 of the following types of publications:
1. o Manuscripts and/or abstracts accepted for publication but not yet published: The entire article should be submitted as a PDF attachment.
2. o Manuscripts and/or abstracts published, but a free, online, publicly available journal link is not available: The entire article should be submitted as a PDF attachment.
3. o Patents directly relevant to the project: The entire document should be submitted as a PDF attachment.

(Do not include unpublished theses, or abstracts/manuscripts submitted (but not yet accepted) for publication.)
Note, publications and/or abstracts in press should no longer be included in the appendix material. Include the URL or PMC submission identification numbers along with the full reference in the Bibliography and References cited section, the Progress Report Publication List section, and/or the Biographical Sketch section.

1. • Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.
2. • Photographs or color images of gels, micrographs, etc., are no longer accepted as Appendix material. These images must be included in the Research Plan PDF. However, images embedded in publications are allowed.

For materials that cannot be submitted electronically or materials that cannot be converted to PDF format (e.g., medical devices, prototypes, DVDs, CDs), applicants should contact the Scientific Review Administrator for instructions following notification of assignment of the application to a study section. Applicants are encouraged to be as concise as possible and submit only information essential for the review of the application.
Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitation will be withdrawn from review. These Appendix limitations may not apply to specialized grant applications. Request and follow the additional instructions for those applications. Specific appendix requirements may also be listed in a specific funding opportunity announcement.
The Appendix will be sent only to certain members of the Scientific Review Group who will serve as the primary reviewers of the application.

1.  Application Type / Federal Identifier

Imports from the SF 424 R&R Cover Page

2.  Change of Investigator / Change of Institution Questions

Complete these questions if a change in PI and/or Institution is involved.

3.  Inventions & Patents

Select answers for these questions if the application type is Renewal.

4.  Program Income

Select Yes or No for Program Income on the project.  If the answer is YES, complete the program income estimates for each budget period. 

5.  Assurances/Certifications

Leave Blank.

Complete the following for each Budget Period:

Start & End Date

Enter the Start Date and the End Date of the Budget Period (MM/DD/YYYY)

A.  Direct Costs

Select the Modular Amount from the drop-down menu.  Enter the total of Consortium F&A, if any. 

B.  Indirect Costs

Indirect Cost Type = MTDC.  Enter the Indirect Cost Rate for your project type and location (research/instruction/other; on or off campus).  Enter the Indirect Cost Base (the amount to which IDC is applied).  Enter the Indirect Cost Total. 

Cognizant Agency

Not required.

Indirect Cost Rate Agreement Date

See Rate Agreement

At the bottom of the page with Budget Period 5:

1.  Total Costs, Entire Project Period

These numbers calculate automatically from your entries in Budget Periods 1-5.

2.  Budget Justifications

Personnel Justification

List all personnel, including names, number of person months devoted to the project (indicate academic, calendar, and/or summer) and roles on the project. Do not provide individual salary information. Since the modules should be a reasonable estimate of costs allowable, allocable, and appropriate for the proposed project, you must use the current legislatively imposed salary limitation when estimating the number of modules.
Attach as a PDF file. Sample justification

Consortium Justification

Provide an estimate of total costs (direct plus facilities and administrative) for each year, rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, along with all personnel, including percent of effort (in person months) and roles on the project. Do not provide individual salary information. Indicate whether the collaborating institution is foreign or domestic. While only the direct cost for a consortium/contractual arrangement is factored into eligibility for using the modular budget format, the total consortium/contractual costs must be included in the overall requested modular direct cost amount.
Attach as a PDF file. Sample justification

Additional Narrative Justification

If the requested budget requires any additional justification, such as variations in the number of modules requested, save this information in a single file in a location you remember.
Attach as a PDF file. Sample justification

Complete the following for each budget period:

Organizational DUNS

Imports from the SF 424 R&R Cover Page.

Budget Type

Select “Project” if UA is the lead institution.  If UA will be the subcontractor on another school’s proposal, use the Subaward Budget provided in the R&R Subaward Budget Attachment Form(s) – which you’ll also use for subcontractors on the UA’s proposal (when a detailed budget is required). 

Start / End Date

Enter the start & end dates for the budget period MM/DD/YYYY

Sections A, B, C, D, E, F

Enter budget items in the appropriate sections.  Salary entry for the PI is required.

Section G

Calculates from Sections A-F

Section H

Indirect Cost Type = MTDC.  Enter the Indirect Cost Rate for your project type and location (research/instruction/other; on or off campus).  Enter the Indirect Cost Base (the amount to which IDC is applied).  Enter the Indirect Cost Total. 

Cognizant Federal Agency

Not required

Section I

Calculates automatically

Section J

DO NOT USE

Section K

This field is required before you can move on to the next budget period.  You may need to attach a file as a placeholder so you can advance to the next budget period, but don’t forget to update the file prior to submission. 

In Budget period 1, attach a PDF file that includes justification text for ALL budget periods.  Only 1 budget justification attachment is allowed on the R&R detailed budget.