# Presentation: 268026

## THE NIH SUBMISSION AND  ASSIGNMENT PROCESS

**Suzanne E. Fisher, Ph.D**
**Director, Division of Receipt and Referral**
**Center for Scientific Review**
**	****	****	****	****	**
**	****	****	****	****	****January 2002**

## WHAT’S IN A NAME?

- NIH perspective - Receipt and Referral
- Applicant perspective - Submission and Assignment
- Multiple activities involving a variety of procedures, policies, and decisions – critical to the NIH Extramural process

## SUBMISSION

- The Division of Receipt and Referral,CSR receives all competitive applications for NIH, also applications for AHRQ, SAMHSA, NIOSH, and small business applications for CDC and FDA
- Twenty-four funding components of NIH
- More than 46,000 applications/year
- Three Receipt/Review/Award cycles per year

## THREE FAVORITE TOPICS FOR DRR

- I would like permission to submit my application late.
- Did you receive my application?  I sent it Fed Ex.
- I sent my application and then I looked at it...

## OPPORTUNITIES ABOUND – A BLESSING AND A CURSE

- _Many _different grant mechanisms used by the Institutes/Centers
- Support ranges from individual predoctoral level to very large resources
- Each Institute/Center uses a different array of mechanisms and may have special requirements
- Investigator-initiated and solicited applications (RFAs)
- Application kits and deadlines vary

## NIH FUNDING COMPONENTS

- NCI
- NEI
- NHLBI
- NHGRI
- NIA
- NIAAA
- NIAID
- NIAMS
- NICHD
- NIDCD
- NIDCR
- NIDDK

- NIDA
- NIEHS
- NIGMS
- NIMH
- NINDS
- NINR
- NLM
- NIBIB
- NCCAM
- NCRR
- NCMHD
- FIC

## COMMON GRANT MECHANISMS

- C06
- F31, F32, F33
- K01, K02, K08, K07, K12, K23, K24, K25
- P01
- P20
- P30, P40, P50, P60
- M01

- R01
- R03
- R21
- R25
- R41, R42
- R43, R44
- T32
- U01

## STAGES IN PROCESSING OF APPLICATIONS

- Loading Dock
- Application Receipt
- Project Control Unit 1
- Referral
- Project Control Unit 2
- Scanning/Duplication/Delivery to review group/IC

## LOADING DOCK

- Receive packages
- Unwrap
- The step we know goes away with electronic submissions!

## APPLICATION RECEIPT

- Date stamp
- Accession number
- Open and count letters
- Separate bulky appendices
- Identify RFAs, other applications for special handling

## PROJECT CONTROL -  UNIT 1

- Record data from page 1, budget, Checklist, Personal Data page
- Match any ARAs (Awaiting Receipt of Application)
- Identify noncompliant budgets ($500k, modular)
- Identify noncompliant forms
- Identify potential duplicates
- Screen for format compliance
- Print PI application history (sponsor history for fellowships)

## REFERRAL PROCESS

- Make sure application is in compliance with policies and should be assigned
- $500k
- Modular budget
- Format
- Revised application
- A2/2 year limit
- Duplicate applications
- Virtual A3s
- Supplement time period matches parent grant
- HESC
- Next policy

## REFERRAL PROCESS (cont.)

- Determine if NIH or other agency application
- CSR or IC review
- Assign
- New, competing, supplement
- Mechanism
- Review location
- Primary and secondary ICs

## PROJECT CONTROL – UNIT 2

- Final data quality check
- Final check for compliance (format, budget, etc.) and matching of any ARAs
- Generation of unique number for new applications
- Prepare application for scanning/duplication and distribution to review and ICs

##  NONCOMPLIANT APPLICATIONS 

- Fix directly if possible
- Shorten title
- Match letters, other material received separately
- Contact IC
- $500k
- Supplements that do not match parent grant

## NONCOMPLIANT APPLICATIONS (cont.)

- Contact PI to correct
- Form
- Format
- Missing reference letters
- Modular Budget
- Supplements
- Return to PI
- Not corrected/or not corrected in time
- $500k
- Not appropriate for NIH (mechanism/IC)

## POST SUBMISSION INTERACTIONS WITH INVESTIGATORS

- Add missing information
- Replace sections
- Assignment suggestions
- Assignment changes
- On time information

## CURRENT PAPER SUBMISSION PROCESS

- Poor track record of compliance in many areas
- Vertebrate Animals, Human Subjects
- Considerable interaction with PIs, institutions, ICs in process
- Applications may be held for correction/clarification at various stages of process

## ELECTRONIC SUBMISSION – OPPORTUNITIES AND CHALLENGES

- Completeness/Compliance
- Research Plan
- Investigator requests
- Receipt dates
- Equity
- Shorten submission to award cycle

## COMPLETENESS/COMPLIANCE

- Facilitate the submission of complete applications; avoid errors of omission
- Facilitate the submission of applications that comply with NIH procedures and policies (and accommodate changes in policies)
- Include “other” materials – letters of reference, collaboration, etc.
- Minimize post submission corrections
- Allow post submission additions
- Integrate on-time information
- Facilitate administrative review by NIH staff at many levels (referral, review, program, grants management)

## RESEARCH PLAN

- Enable investigators to present scientific information in a way that they feel makes the best case, shows necessary information in figures, tables, etc.
- Apply appropriate limits for text size, font, margins, etc.

## INVESTIGATOR REQUESTS

- Identification of mechanism and any special requirements
- “Self Referral” - suggestions for assignment for review and potential funding IC(s)

## RECEIPT DATES

- Handle large volume
- 47,000 or more a year
- 4,000 in one day
- Application and Appendix materials
- Reasonable flexibility for late applications (study section members, natural disasters, family emergencies)

## EQUITY

- Accommodate wide range of application types (fellowship, small business, research, centers)
- Accommodate range of applicant organizations
- Referral, review, award processes will be using both electronic and paper modes for some time
- Need to be sure that neither mode is advantaged or disadvantaged

## SHORTEN CYCLE

- Elimination of paper handling, data entry, etc. will eventually allow change in receipt dates, less time for receipt and referral stages
- May not lead to significant changes in time allowed for recruitment of reviewer or “homework” by reviewers
- Still expect to convene study section meetings

## CONCLUSION

- Change to electronic submission provides an opportunity to re-engineer grant application practices and improve the process
- This will require a lot of “hard” thinking and work in advance