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This section of the NIH application allows up for a maximum of 10 PDF attachments. The Appendix is not to be used to circumvent page limits of the Research Strategy or any other section of the application for which a page limit applies.
Please see the following NIH Notice for guidance on information that may be including in the Appendix of an application: NOT-OD-07-018.
This section of research involves human subjects that are typically patient-oriented as well as includes epidemiological and behavioral students or outcomes research and health services research. Per NIH, a clinical trial “is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” At UC San Diego, you will need to work with the Humans Research Protections Program (HRPP) office and submit a Human Subjects protocol(s) for the trial(s). Click here for more information on clinical research and trials.
A formalized agreement whereby a research project is carried out by the grantee with one or more other organizations that are separate legal entities. The grantee, as the direct and primary recipient of a grant funds, is accountable for the performance of the project, the appropriate expenditure of grant funds by all parties, and all other obligations of the grantee, as specified in the NIHGPS. In general, the requirements that apply to the grantee flow down to the consortium participant(s). The grantee is responsible for including the applicable requirements of the NIHGPS in its agreements with collaborating organizations.
The award will be made to a single grantee with a single PI (or as the Contact PI if the award is a MPI award), even though one or more organizations other than the grantee will carry out portions of the planned programmatic activity. The grantee must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties.
For more information on Outgoing Subawards and UC San Diego's Process, click here.
NIH has implemented policy and procedures to allow appointed members of NIH Review and Advisory Groups and peer reviewers with recent substantial service (six times in 18 months), to submit their research grant applications on a continuous basis and to have those applications undergo initial peer review in a timely manner. The continuous submission policy is limited to NIH R01, R21, and R34 applications that would normally be received on standard submission dates. Continuous submission is NOT available for applications submitted for special dates. Please seeNOT-OD-11-093 for additional information. Please check the following NIH website to see if your PD/PI is eligible for continuous submission.
Temporary or ad hoc reviewers who are not eligible for continuous submission are eligible for the late submission window. See NOT-OD-11-035.
The Cooperative Agreement (U series) is a support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program stuff will assist, guide, coordinate, or participate in project activities. Cooperative Agreements are typically awarded in response to an RFA and they will frequently include special terms and conditions.
The performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that meet this definition include, but are not limited to, (1) the involvement of human subjects or animals, (2) extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities, or (3) any activity of the recipient that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country.
Foreign travel for consultation is not considered a foreign component.
A notice of grand funding opportunity. Funding opportunities include a description of the opportunity as well as information on award and award administration, eligibility, application and submission instructions, application review, agency contacts, and other information regarding the funding opportunity.
Funding opportunity announcements may be known as program announcements, requests for applications, notices of funding availability, solicitations, or other names depending on the agency and type of program. Funding opportunity announcements can be found at Grants.gov/Find and in the NIH Guide for Grants and Contracts. In addition, NIH and other HHS Agencies have developed omnibus Parent Announcements for common grant mechanisms that have transitioned to electronic submission, for use by applicants who wish to submit what were formerly termed "unsolicited" or "investigator-initiated" applications.
At UC San Diego, it is very important for your HS SPPO Analyst to know what it is you are applying to, especially if we are a consortium/subaward. HS SPPO will use the FOA to determine the appropriate office the proposal should go through, either HS SPPO, OCGA, or Graduate Division (if it is a non-professional graduate fellowship application).
Should be treated the same as domestic consortiums, except an additional justification is required in Other Project Information section. Under Item 5a, mark “yes” that this “project involve activities outside the U.S…;” under Item 5b, list the country(s) involved; and under Item 5c state “See justification under Item 11. Other Attachments,’ where you will justify the reason for work outside the U.S. For more information, please see the appropriate application guide.
Most often, foreign research institutions do not have a DUNS #, but some do. If they not have one, then use the following for the DUNS #: 000000000 (nine zeroes). If awarded, they will be required to obtain one. With regards to an Entity Identification Number (EIN), use 44-4444444 in the Face Page. For Congressional District, use 00-000 (2 zeroes, than a dash, and three zeroes). For F&A, use 8%, unless they have a federally-negotiated F&A Rate, which is rare.
Permission is not granted in advance for submission of a late application. Late applications are accepted only in extenuating circumstances. If an application is submitted late, a cover letter attachment explaining the reasons for the delay must be included with the signed, completed application. Late applications are evaluated on an individual basis considering the reasons provided. See NOT-OD-15-039 for more information.
NIH does not allow for Co-Principal Investigators on proposals/awards, but they have created a comparable role called the Multiple PD/PI. The MPIs have the same role and responsibilities as each other. The only difference is the Contact PI, who is responsible for being the contact person with NIH and it is their research organization that submits, processes, manages and the award. “The overarching goal is to maximize the potential of team science efforts in order to be responsive to the challenges and opportunities of the 21st century.” For more information, please see NOT-OD-11-118 as well as click here for NIH’s page MPI.
Notices announce policy and procedures, changes to RFA or PA announcements, RFPs and other general information items. For a list of all related Guide Notices, click here.
Parent Announcements are utilized for unsolicited or investigator-initiated applications to NIH and are submitted during three separate submission cycles. The use of this ensures the applicant uses the appropriate SF424 application package. Parent announcements are widely used by NIH-wide, however, not all ICs utilize all of them, except for the R01 – which is used by all. You will need to refer to the appropriate parent announcement FOA to determine whether or not the IC you wish to apply to accepts the particular announcement of not. For more information on parent announcements, click here.
Under certain circumstances, NIH allows for additional supplementary materials submitted to the Scientific Review Officer (SRO) prior to initial peer review. Additionally, this can be used when “an unexpected event such as the departure of a participant, natural disaster, etc has occurred.” This cannot be used to correct oversights and/or errors discovered post submission. For more information on what is allowable as well as the policy, please see the most recent notice on post submission application materials, NOT-OD-13-030.
Post-submission materials are due 30 days prior to the peer review meeting. Concurrent from the Authorized Organization Representative (AOR) of the application organization is required.
A PA identifies areas of increased priority and/or emphasis on particular funding mechanisms for a specific area of science and are usually accepted on standard receipt (postmarked) dates on an on-going basis. PAs remain active for three years from date of release unless the announcement indicates a specific expiration date or the NIH Institute/Center (I/C) inactivates sooner. Click here for the most recent PAs and other FOAs with NIH.
- PAR: is a PA with special receipt, referral and/or review considerations, as described in the PAR announcement
- PAS: is a PA that includes specific set-aside funds as described in the PAS announcement.
The individual(s) designated by the application organization to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designed multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically.
The RePORT (Research Portfolio Online Reporting Tool) website provides access to a variety of reporting tools, reports, data, and analyses of NIH research activities. One of the tools available on the RePORT website is the RePORTER (RePORT Expenditures and Results) module. RePORTER is an electronic tool that allows users to search a repository of NIH-funded research projects and access publications and patents resulting from NIH funding.
An RFA identifies a more narrowly defined area for which one or more NIH institutes have set aside funds for awarding grants and they usually have a single receipt (received on or before) date specified in the RFA announcement. RFAs are usually reviewed by a Scientific Review Group convened by the issuing awarding component.
Announces a solicitation for contract proposals to meet a specific need, such as the development of an animal model. RFP's usually has one receipt date, as specified in RFP solicitation.
- Career Development Awards (CDA/K series): is typically an award focused on early stage investigators to assist with further developing their careers in biomedical, behavioral and clinical research or for researchers changing careers. Click here to be directed to the Career Development Kiosk for more information on the different programs as well as eligibility as well as refer to the appropriate section of the SF424 Application Guide, §7 Supplemental Instructions for Preparing Individual Research – Individual Career Development Award Programs.
- Cooperative Agreements (U series): is a support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities. Cooperative Agreements are typically awarded in response to an RFA and frequently they will include special terms and conditions, in addition to those that generally apply to awarded grants. The U01 is the most common of the U series and is a Research Project Cooperative Agreement that supports discrete and specific projects to be performed by investigator(s) in an area representing their specific interests and competencies. Note, you cannot use the Modular Budget format for competing proposals. You must prepare the NIH detailed budget pages for a program project. The cooperative agreement applications follow the standard instructions of the SF424 Application Guide.
- Individual Fellowships (F series): provide institutional research training opportunities to trainees at the graduate and postdoctoral levels. At UC San Diego, all professional degree graduate students (MD, PharmD, MD/PhD, or PharmD/PhD) and postdoctoral fellows will submit their applications through HS SPPO. For more information on submitting an NIH fellowship through HS SPPO, click here. Moreover, click here to be directed to the NIH Fellowship Kiosk for more information on the different programs as well as eligibility as well as refer to the Individual Fellowship SF424 Application Guide.
- Institutional Training Grants (T series): provides institutional research training opportunities (including international) to trainees at the undergraduate, graduate, and postdoctoral levels, led by an established PI. Click here to be directed to the NIH Research Training Kiosk for more information on the different programs as well as eligibility as well as refer to the appropriate section of the SF424 Application Guide, §8 Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein – Research Training Programs.
- Program Project/Center Grants (P series): is a program project grant that provides an institution with support for a multi-disciplinary, long-term research program with an objective or theme involving groups of investigators. Awarded on behalf of a principal investigator, the grant can support multiple projects and shared resources (cores). Whereas a center grant supports shared resources for a multi-disciplinary research group of investigators focused on a common research topic. Note, you cannot use the Modular Budget format for competing proposals. You must prepare the NIH detailed budget pages for a program project. Click here for more information on the different programs as well as eligibility as well as refer to the appropriate section of the SF424 Application Guide, §9 Supplemental Instructions for Using ASSIST to Prepare a Multi-Project.
- Research Grants (R series): is typically used to support a specified research project, or may provide limited funding for a short period of time, and they may be unsolicited or solicited applications. All ICs accept unsolicited proposals for the R01 mechanism, but for all other mechanisms, you will need to check with the FOA to see which IC will accept proposal applications and which ones will not. Note, modular or detailed budgets are utilized, depending on the amount requested in each budget year. Click here for more information on research grants as well as mechanisms. The research grant applications follow the standard instructions of the SF424 Application Guide.
- Small Business Innovation Research Grant (SBIR) & Small Business Technology Transfer Research Grants (STTR): programs are one of the largest sources of early-stage capital for innovative small companies in the United States. Per NIH, “the SBIR program funds early stage small businesses that are seeking to commercialize innovative biomedical technologies. This competitive program helps small businesses participate in federal research and development, develop life-saving technologies, and create jobs.” While the “the NIH STTR program is similar to the NIH SBIR program, but requires that the small business formally collaborate with a research institution in Phase I and Phase II.” UC San Diego is not allowed to be the prime submitting agency with either of these two types of opportunities, instead, we act as the educational component – aka consortium/subaward. Click here for more information on the SBIR & STTR programs.
- Streamlined Non-Competing Award Process (SNAP): is a streamlined process that includes a number of provisions that modify annual progress reports, NOAs, and financial reports. Unobligated balances of under 25% are automatically carried over to the next budget year, without prior approval or permission. All NIH award notices identify whether the grant is subject to or excluded from SNAP. At UC San Diego, if an award is SNAP-eligible, then the PI has been delegated authority to submit their own progress report in the RPPR module in eRA Commons. You will need to process, on your own or with the assistance of your Fund Manager, your annual FCOI Form. For more information on SNAP, click here.
- Non-streamlined Non-Competing Award Process (Non-SNAP): is not a streamline process or subject to the SNAP process and typically includes a detailed budget in the RPPR module in eRA Commons. At UC San Diego, if an award is NOT SNAP-eligible, then the PI does NOT have delegated authority to submit their own RPPR in eRA Commons and this will need to be submitted by your HS SPPO or OCGA Analyst. You will need to obtain a new UCSD #, signatures on a new RES Form, Internal Budget, and process your annual FCOI Forms for all key persons on the grant.
RePORT assists NIH with transparency and public accountability. RePORT “provides access to reports, data, and analyses of NIH research activities, including expenditures and the results of NIH supported research. It is also a great tool to use for PIs in search of potential future collaborators. Click here for more information as well as the search tool.
Every Fiscal Year (FY), the Consolidated and Further Continuing Appropriations Act restricts the amount of direct salary paid on NIH awards. Currently, the Congressionally-set NIH Salary Cap is at Executive Level II. For FY 2015, this is $189,600. Please click here
for the current rates as well as to see NOT-OD-15-049
for the current notice on salary limitations on grants, cooperative agreements, and contracts.