# Presentation: 224758

## Institutional Clinical and Translational Science AwardRFA-RM-07-007Pre-Application Meeting

**Carol Alderson**
**Office of Grants Management, NCRR**
**May 14, 2007**

## CTSA Pre-Application Meeting

**Multiple PI - Application Format **
**Institutional Predoctoral Research Training Component (optional)**
**Preparing your budget: summary budget spreadsheet, from NCRR’s website **
**Preparing your budget: organization and justification**
**Participant and Clinical Interactions Resource**
**Foreign Component (optional)**
**Checklist**

**Notes:**
TOPICS TO COVER

## Multiple PI - Application Format (cont.)

**To facilitate communication with the NIH, the applicant organization will be asked to select a “Contact PI” at the time of application.  The Contact PI: **
- will be responsible for relaying communications between all of the PIs and the NIH.
- must meet all eligibility requirements for PI status in the same way as other PIs, but has no special roles or responsibilities within the project team beyond those mentioned above.
- may be changed during the project period.

**Notes:**
It is also possible, and may be desirable, for the grantee institution to periodically designate a change in Contact PI. For example, it may be desirable to rotate the role of Contact PI among the Multiple PIs on an annual basis at the time of grant renewal. 

## Multiple PI - Application Format (cont.)

**The PHS 398 was revised in April, 2006, to accommodate the MPI research model**
**The eRA Commons User Name (the unique name used to log into the system) is now **required **for all PIs.**
**URL to the 4/2006 PHS 398:**
- _[http://grants1.nih.gov/grants/funding/phs398/phs398.html](http://grants1.nih.gov/grants/funding/phs398/phs398.html)_

**Notes:**

IN ADDITION TO IMPLEMENTING MULTI-PI, THE NEW 398 REFLECTS THE CHANGE TO PERSON-MONTHS (CONSISTENT WITH THE SF 424) AS WELL AS SEVERAL OTHER CHANGES
DATA ELEMENTS NEEDED FOR EACH PI:
3A – NAME
3B – DEGREE
3C – POSITION
3D – MAIL& EMAIL ADDRESSES 
3E  - DEPARTMENT, SERVICE, LABORATORY OR EQUIVALENT
3F  - MAJOR SUBDIVISION
3G – TELEPHONE/FAX
3H – eRA COMMONS USER NAMES

## Multiple PI - Application Format (cont.)

**Form Page 1, **_**Face Page**_**:**
**When multiple PIs are proposed for your CTSA application, use a unique Face Page to provide items 3a – 3h for all proposed PIs. **

## Multiple PI - Application Format (cont.)

**Form Page 2, “**_**Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells**_**:” **
**When multiple PIs are proposed for your CTSA application, list the contact PI first, then all additional PIs in alphabetical order. **
**All other Key Personnel should follow the list of PIs, listed in alphabetical order, last name first. **

## Institutional Predoctoral Research Training Component (optional):

**Changes to NRSA policy, effective August, 2006:**
**Include health insurance in the Training Related Expenses Category**
**F&A is calculated at a rate of 8%, excluding tuition/fees & equipment**
**Notice of New NIH Policy for Funding of Tuition, Fees, and Health Insurance on Ruth L. Kirschstein National Research Service Awards Notice Number: NOT-OD-06-090****, **
_**[http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-090.html](http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-090.html)**_

**Notes:**
PREVIOUSLY THE F&A BASE WAS DC EXCLUDING TUITION/FEES/HEALTH INSURANCE AND EQUIPMENT

## Preparing your budget:

**Composite spreadsheet on NCRR’s website: will present the total costs of the U, K and T components of your CTSA application**
**NIH currently doesn’t have a single form to reflect both research and NRSA budget categories**
**Please consider submitting NCRR’s composite spreadsheet**
**Place composite spreadsheet before your composite budget for the “U” component of your application**
**Link to CTSA composite spreadsheet: Fillable Excel Spreadsheet for Documenting a CTSA Budget (rev. 5/2007) **
_**[http://www.ncrr.nih.gov/clinicaldiscipline/CTSA_budget.xls](http://www.ncrr.nih.gov/clinicaldiscipline/CTSA_budget.xls)**_

**Notes:**
THE PHS 398 APPLICATION DOESN’T INCLUDE A FORM FOR BOTH RESEARCH AND TRAINING GRANTS, SO THIS SPREADSHEET IS OFFERED FOR YOUR ASSISTANCE and OUR BENEFIT.

THE SPREADSHEET IS LOCATED ON NCRR’S CTSA PAGE, IMMEDIATELY AFTER THE RFA

THERE ARE TWO WORKSHEETS IN THIS EXCEL FILE, ONE WITH SEVEN FUNCTIONS IN THE U COMPONENT AND ONE WITH  ELEVEN FUNCTIONS IN THE U COMPONENT 

## Preparing your budget (cont.):

**Present the composite budget of your “U” component of your CTSA application after the NCRR spreadsheet**
**The composite budget will include:**
-  Form Page 4:  Detailed Budget for Initial Budget Period
- Form Page 5:  Budget for Entire Proposed Period of Support

## Preparing your budget (cont.):

**For each key function, present the budgets & justification in this sequence:**
**Form Page 4:  Detailed Budget for Initial Budget Period**
**Form Page 5:  Budget for Entire Proposed Period of Support**
**Continuation Page: Budget justification**

**Notes:**
KEY FUNCTION OR PEDIATRIC PI 

A SEPARATE BUDGET & JUSTIFICATION IS NEEDED FOR EACH KEY FUNCTION.
A SEPARATE BUDGET & JUSTIFICATION IS NEEDED FOR EACH CONSORTIUM
IF YOUR APPLICATION PROPOSES A PEDIATRIC PI WHO REQUEST DIRECT AUTHORITY OVER A SEPARATE BUDGET AND INFRASTRUCTURE FOR PEDIATRIC CLINICAL RESEARCH,  PRESENT THIS REQUEST ON A SEPARATE BUDGET, TO INCLUDE FORM PG 4 DETAILED BUDGET, FORM PAGE 5, BUDGET FOR ENTIRE PROPOSED  PERIOD OF SUPPORT AND A DETAILED JUSTIFICATION 
SHOULD THE PEDIATRIC PI BE LOCATED AT A DIFFERENT INSTITUTION, THIS BUDGET SHOULD BE INCLUDED AS A CONSORTIUM TO THE APPLICANT INSTITUTION. 

## Preparing your budget (cont.):

**If the requested key function has a consortium, place the consortium budget & justification (Form Page 4, Form Page 5, and continuation page) immediately after the budget justification for the corresponding key function.**
**Include a “Resources” page for each consortium.**

## Preparing your budget (cont.):

**All requested costs must be clearly justified on Form Page 5 & continuation pages.**
**Requested costs must be reasonable, allowable, allocable to the project, and  conform to any limitations set forth in the cost principles. **

## Participant and Clinical Interactions Resources

**If your CTSA application proposed a “Participant and Clinical Interactions Resources:**”** **
**please describe the relationship between the personnel listed in the budget and the PCIR site in the Resources section of your application.**
**Provide details on any special rates used (e.g. patient care) in the budget justification**

## Foreign Component (optional):

**If your CTSA application proposed a foreign component:**
**Provide a justification on Form Page 5/continuation pages **
**Describe special resources or characteristics of the research project (e.g., human subjects, animals, disease, equipment, and techniques), whether similar research is being done in the United States and whether there is a need for additional research in this area. **
**List foreign sites on Form Page 2 **
**List foreign sites on the Checklist, ***and*** list countries involved**

## Checklist – calculation of F&A

**If your CTSA application requests an off-site rate, other special rate, or more than one rate, include an explanation of the rate(s) and base(s) used ****	**

**Notes:**
ATTACH SEPARATE SHEET, IF NECESSARY

## Questions? Grants Management contact for this RFA is Mary NiemiecTelephone: (301) 435-0842FAX: (301) 480-3777Email: niemiecm@mail.nih.gov Thank you!

**Notes:**
Key DatesRelease Date: March 22, 2007Letters of Intent Receipt Date(s): September 24, 2007Application Receipt Date(s): October 24, 2007Peer Review Date(s): February - March 2007Council Review Date(s): May 2008Earliest Anticipated Start Date(s): July 1, 2008Additional Information To Be Available Date (URL Activation Date): April, 2007Expiration Date: October 25, 2007

Grants Management contact is Mary Niemiec
Telephone: (301) 435-0842FAX: (301) 480-3777
Email: niemiecm@mail.nih.gov