Effective January 1, 2008

All sponsored activities (including research, instruction, service, clinical research, and clinical trials/drug/device studies) must be submitted to the Office of Grants Management or Office of Industry Contracts for approval prior to submission to the sponsor.

I. ELECTRONIC PROPOSAL SUBMISSION TO FEDERAL GRANTING AGENCIES:

PDs are required to submit the entire completed and final electronic proposal (Grants.Gov), inclusive of ALL components (as opposed to the fractional components required for paper proposals and non-federal electronic proposals) to their Grants Management or Industry Contracts representative seven (7) full business days prior to the federal granting agency deadline. (Use the Industry Contract Service Account when submitting your electronic proposal submissions to the Office of Industry Contracts. Put “NIH E-Submission” as a part of the subject line.)

A hard copy of the SF424 signature page, abstract, budget and budget justification/narrative must be attached to the completed hard copy PCF and submitted concurrently with the electronic proposal.

Each proposal must include a completed Proposal Clearance Form with signatures of the project director (PD), co-directors (Co-PD), faculty members with committed effort, key personnel, department chair, dean or appropriate unit heads.

Note: Submission of SBIR/STTR proposals are to follow this procedure by including the electronic version of the UofL specific consortium pages of the electronic proposal that the small business will incorporate into their submission along with the completed hard copy PCF and associated attachments outlined above.

II. OTHERS

For other funding agencies PDs are required to submit the face page requiring university signature authorization, all sponsor form pages, an abstract/description of the scope of work/project , budget (including personnel and % effort), budget justification/narrative, and a contract if appropriate, to their Grants Management or Industry Contracts representative five (5) full business days prior to the granting agency deadline.

Each proposal must include a completed Proposal Clearance Form with signatures of the project Director (PD), co-directors (Co-PD), faculty members with committed effort, key personnel, department chair, dean or appropriate unit heads.

OFFICE SUBMISSION GUIDELINES:

1. If question 5a or 5b on the PCF is yes, submit the proposal to the Clinical Research Services division of the Office of Industry Contracts.

2. If the proposal involves a small business or other for profit entity with a governmental flow-through such as the SBIR/STTR or KSTC programs where the business will contract with the University (not the governmental agency), submit the proposal to the Office of Industry Contracts.

3. If the sponsored activity is funded by a governmental or non-profit entity, submit the proposal to the Office of Grants Management.

4. If the sponsored activity is funded by a for-profit/industry entity, submit the proposal to the Office of Industry Contracts.

PROPOSAL CLEARANCE FORM (PCF) INSTRUCTIONS

1. The Project Title listed should be the official title of the proposal. This will provide the Office of Grants Management or Industry Contracts the ability to locate the proposal if limited information is provided during negotiation/award. A non-confidential title should be used.

2. List complete information for PD, Co-PDs and all other participants. If the proposal involves Co-PD's, please complete for each. Also answer for other UofL participants - use the hyperlink for the additional participant’s page. (Required for key personnel at time of proposal, all others at time of award.) List any unfilled position by role on project (ex., postdoctoral fellow, GRA, etc).

The Department Name and Number refer to the Academic Appointment (ACAP) of the PD and Co-PDs.

The % Effort on the Project is the % of University effort being committed for this project.

The % Collaboration must total 100%, distributed among appropriate research personnel. This information determines the distribution of Research Infrastructure Funds (RIF) and Departmental Research Infrastructure Funds (DRIF). Some units also use this information for issues such as space allocation. Please check with your respective unit for additional guidance.

The intellectual property policy of the U.S. Department of Veterans Affairs (VA) governs employees (with or without compensation, full- or part-time). Complete this line if you have any type of appointment with VA or VA Hospital. For example, if you have a dual or joint appointment with VA Hospital, this policy impacts the intellectual property of research you do with others. You may be required to disclose intellectual property of research to the VA. Indicate the amount or percentage of your appointment with VA.

3a. Identify the agency, company, or foundation to which this proposal will be sent and which will issue payments directly to the University. Check appropriate box to identify if primary source of funding to this sponsor will be federal- or state-sponsored. Identify the funding agency URL (web address). For non-governmental sponsors, identify a contact name and full contact information.

3b. If this is a collaborative project, a potential subaward agreement or other flow-through arrangement, indicate name of entity providing overall funding but not direct payments to the University. Check box if not applicable. Identify the funding agency URL (web address). For non-governmental sponsors, identify a contact name and full contact information.

4. Identify the name of the program to which you are applying. Indicate the Agency Program number and the CFDA number if applicable or known.

5a. Indicate if project is a clinical trial, device study or drug study using the operational definition of clinical trial for the purpose of proposal submission provided below. If yes, include a completed Clinical Attachment available at http://louisville.edu/research/offices/industry-contracts/common/mira-multi-institutional-research-application-information.html and submit the proposal to the Clinical Research Services division of the Office of Industry Contracts.

Definition
For purposes of proposal submission

• Study in which human subjects are assigned to a group that receives a clinical/medical intervention (e.g. medication, clinical/medical procedure, device) and/or a control group for a clinical condition and who interact with study personnel, having provided an informed consent.

• Clinical condition – symptom, set of symptoms or a diagnosis as determined by a qualified investigator

• Note: Consenting to the use of a biological fluid or tissue sample only for subsequent study does not constitute a clinical trial as there is no ongoing interaction between the investigator/study personnel and the human subject

5b. Indicate if the project will use the clinical services/resources or facilities of an external entity/health care provider (e.g. Norton Healthcare, Jewish & St. Mary’s, University Hospital, VAMC.) If yes, include a completed Clinical Attachment available at http://louisville.edu/research/offices/industry-contracts/common/mira-multi-institutional-research-application-information.html and submit the proposal to the Clinical Research Services division of the Office of Industry Contracts.

5c. Indicate if the project will involve specimens, tissues or personally identifiable (not deidentified as defined by HIPAA) data/information (“human materials”). If yes, include a completed Clinical Attachment available at http://louisville.edu/research/offices/industry-contracts/common/mira-multi-institutional-research-application-information.html. The PCF with the Clinical Attachment is submitted to the Office of Grants Management if a governmental or non-profit sponsor or the Office of Industry Contracts if a for profit/industry sponsor.

5d. Indicate if human materials or other biological/chemical materials are being received by the University from another entity or if we are sending such from the University to another entity.

6. Indicate whether funding instrument will be a grant, subgrant/subcontract, cooperative agreement or contract. For guidance, see the Research Handbook, Section 3.2.

7. Indicate whether award will be new, a competitive renewal, a continuation, a supplement or a transfer.

8. Indicate whether the project type is research, clinical research, clinical trial, training/education, public service or other sponsored research.

(Clinical research involves human subjects but the project does not meet the definition of a clinical trial as specified in 5a above.)

9. Indicate if the Development Office participated in the proposal preparation.

10. Identify any Board of Trustees-approved center or institute through which this research will be conducted.

11. Identify any UofL service center participating in this research. Include an estimate of the budget from this project for the service center and the time period in which the center will be utilized.

12. Please identify the category closest to your efforts on this project. If your area is not specifically listed, please use one of the OTHER Options and provide specific information in the indicated area.

13. Please list keywords appropriate for research interests related specifically to this proposal. These keywords identify faculty research areas in order to match them to requests for information and for distributing extramural funding opportunities.

14. If the project is going to use human subjects, animals, or agents impacting environmental health and safety (ionizing radiation devices/isotopes; recombinant DNA; pathogenic organisms; CDC/USDA select agents; human blood, tissues, cell lines, OPIM; highly toxic, carcinogenic, mutagenic agents), the proposal must be submitted to the respective committees for internal review. If the project will involve one of the items a – h, (i.e. yes is checked), the Project Director must contact the appropriate office or committee that oversees the safe use and regulation of these items.. Compliance committees and offices, including contact numbers, are listed on http://louisville.edu/research/for-faculty-staff/compliance-contacts.html. The University will accept an "approval pending" if the internal review is not completed prior to the proposal deadline unless prior approval is required by the sponsoring agency. A copy of the approval letter(s) associated with the project (or other official approval mechanism used by the committee) must be on file in the Office of Grants Management or Industry Contracts prior to chartfield establishment. For clinical trials, a chartfield may be established for site initiation visits and other start-up costs and the clinical trial agreement may be executed prior to receiving final IRB approval, but no human subjects can be consented/enrolled without the IRB approval. If available at the time of proposal submission, list the IRB, IACUC or IBC project number in the respective area and indicate the status for items a-h. Approvals from IRB, IACUC or IBC referencing the OGM/OIC project number should be supplied to OGM or OIC upon receipt of approvals to avoid delays in establishment of the award.

In Item i, indicate if equipment or software will be supplied by sponsor and if Risk Management has been so notified for insurance purposes.

15a. Faculty release time occurs when an appropriate percentage of time is not available according to the annual workload agreement.

15b. Salary recovery occurs when any portion of a faculty member’s University-sponsored institutional base salary is to be paid by the sponsor.

15c. Approved Additional Non-Base Pay (formerly known as “x-pay”) is considered only on an exceptional basis. The faculty member must sign a statement indicating that the effort on the grant plus any outside work does not exceed an average of one day per week paid by UofL as permitted under Section 4.3.3 of the Redbook. If the effort exceeds the "one day per week" rule, salary release to compensate the University, must be recovered.

15d. Check “yes” if SPONSORING AGENCY requires cost share or matching funds.

15e. The unit dean should provide notification to central administration if such commitments will require collaboration between units or support from central administration.

15f. The unit dean is responsible for assuring new courses, degree programs, centers or institutes are appropriate and will be implemented.

15g. The unit dean is asked to approve a plan for the need for additional space or facilities to provide information for overall planning. Where will the bulk of the University work take place? If more than 50% of a project is performed off-campus (exclusive of any subcontract performance sites), the off-campus rate will apply to the entire project. Grants or contracts will not be subject to more than one facilities & administrative cost (a.k.a. indirect cost) rate. (See information under 16d of this document.) Identify the campus, building and room number.

15h. The unit dean must approve a plan for any of these activities to provide information for overall institutional planning.

15i. The unit dean should consider what might be needed and be sure to provide pertinent information to others affected.

15j. This information is required to meet the state approval guidelines for the purchase of major equipment. Include the contact person and phone number.

BUDGET SECTION:

When completing the budget section, please include the amounts for the ENTIRE PERIOD OF THE PROPOSAL. As a result it will not be necessary to complete a new PCF each year of the funded project. Once the PD, chair, and appropriate unit head approve the initial proposal, their approvals are not necessary for subsequent years.

16a. Indicate previously assigned PCF number if proposal is for a renewal, continuation or supplement of an existing award or contract.

16b. If the Department ID number for budget and expenditure purposes is different than the primary appointment of the PD, it must be listed.

16c. Budget Period - Indicate the time frame (month/day/year) for which the funds are requested. If the grant period is more than one year, include funds requested for all years.

16d. Sponsor Requested - Direct Costs: Budget categories should include amounts requested from the sponsor. List equipment costing less than $5,000 under Supplies & Expense. List the total amount for all subcontracts on this Subcontracts line; identify subcontracts individually in Item 17.

Facilities & Administrative Cost (F&A) (a.k.a. Indirect Cost) Rates

16e. UofL Cost Share - Cost sharing must be identified if: Sponsor requires specific matching (University or third party); time and effort of University personnel on the project is not allowed by the sponsor; Salary being requested is not equivalent to committed effort; Cost sharing is committed in the narrative of the proposal (University or third party).

NOTE: Due to federal rules all committed cost sharing identified in the proposal to the sponsor must be separately budgeted and accounted for. Non-mandatory cost sharing should not be committed.

Budget categories should include amounts of in-kind or new funds needed for the project. The source of these funds must be identified by speedtype number. In-kind funds are those already available for the project. New funds are new dollars from UofL sources not currently available, but approved for this project. Cost sharing guidelines are available on the Sr. Vice President for Research web site at http://louisville.edu/research/policies-procedures/general-guideline-for-cost-sharing-matching-requests-for-grants-contracts-and-fellowships.html. The University's policy concerning tuition remission for GRA on grants and contracts is available on the Vice President for Finance website at http://louisville.edu/finance/budget/policies/budpol.html. If there is a third-party cost share, please enter name of entity, type of cost sharing, and amount in Budget Remarks section. Also, submit with the PCF written confirmation of the agreement FROM the third party. ANY COST-SHARING MUST BE APPROVED IN WRITING BY THE APPROPRIATE OFFICIAL PRIOR TO THE SUBMISSION TO THE OUTSIDE AGENCY.

16f. Budget Remarks: Please comment on any cost share or third-party match and on any budget item requiring explanation.

17. List any organizations—including Professional Services Corporations (PSC) or Private Practice Plans—that will provide services or receive payments from ULRF for this project. Include these costs in Subcontracts line in budget.

18. Responsible Signatory: Each Project Director, Co-Director, faculty member with committed effort, key personnel, department chair (or appropriate unit head), and unit dean (or appropriate unit head) must sign. Additional signature lines are available on a separate page accessible from Item 1 on the PCF. Each signatory must be aware of what he/she is signing and his/her individual level of responsibility.

REMINDERS:

1. It is possible that your unit has procedures or requirements in addition to those indicated here.

2. The responsible signatures must be obtained BEFORE the clearance form (PCF) is submitted to the Office of Grants Management or Industry Contracts for final approval.

3. If you are aware of intellectual property issues on this project, please review our Intellectual Property Policy website at http://thinker.louisville.edu/ippolicy.htm. Contact the Office of Technology Transfer if you have any questions.

4. Please remember to include the name of the individual to be contacted for questions and follow-up by Grants Management or Industry Contracts. When possible it is recommended to list someone in addition to the PD. Include the agency deadline date (if applicable) at the top of the PCF form.

5. The Office of Grants Management or Industry Contracts will contact your department when your approved proposal is ready to be picked up.

6. You are responsible for getting your proposal to the outside agency by the proposal deadline, unless other arrangements have been made in advance. The Office of Sponsored Programs Development will copy and mail your proposal to the agency if it is provided to the Office of Sponsored Programs Development (OSPD) in final form seven (7) working days before the deadline and arrangements are made with an OSPD staff member.

7. All award notifications must be sent to the Office of Grants Management or Industry Contracts who will notify the PD, any Co-PDs and the unit liaisons of the university chartfield and speedtype numbers assigned to the funded award. When the PD learns from the sponsoring agency that funding for the proposal looks promising or likely, please notify the Office of Grants Management or Industry Contracts so that items needing to be completed prior to time of award can be addressed.

8. If you have any question about the items on the PCF, please call the appropriate Office of Grants Management or Industry Contracts.

01/02/2008