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

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

OPPORTUNITIES ABOUND – A BLESSING AND A CURSE n Many different grant mechanisms used by the Institutes/Centers n Support ranges from individual predoctoral level to very large resources n Each Institute/Center uses a different array of mechanisms and may have special requirements n Investigator-initiated and solicited applications (RFAs) n Application kits and deadlines vary

NIH FUNDING COMPONENTS n NCI n NEI n NHLBI n NHGRI n NIA n NIAAA n NIAID n NIAMS n NICHD n NIDCD n NIDCR n NIDDK n NIDA n NIEHS n NIGMS n NIMH n NINDS n NINR n NLM n NIBIB n NCCAM n NCRR n NCMHD n FIC

COMMON GRANT MECHANISMS n C06 n F31, F32, F33 n K01, K02, K08, K07, K12, K23, K24, K25 n P01 n P20 n P30, P40, P50, P60 n M01 n R01 n R03 n R21 n R25 n R41, R42 n R43, R44 n T32 n U01

STAGES IN PROCESSING OF APPLICATIONS n Loading Dock n Application Receipt n Project Control Unit 1 n Referral n Project Control Unit 2 n Scanning/Duplication/Delivery to review group/IC

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

REFERRAL PROCESS n 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.) n Determine if NIH or other agency application n CSR or IC review n Assign –New, competing, supplement –Mechanism –Review location –Primary and secondary ICs

PROJECT CONTROL – UNIT 2 n Final data quality check n Final check for compliance (format, budget, etc.) and matching of any ARAs n Generation of unique number for new applications n Prepare application for scanning/duplication and distribution to review and ICs

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

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

POST SUBMISSION INTERACTIONS WITH INVESTIGATORS n Add missing information n Replace sections n Assignment suggestions n Assignment changes n On time information

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

ELECTRONIC SUBMISSION – OPPORTUNITIES AND CHALLENGES n Completeness/Compliance n Research Plan n Investigator requests n Receipt dates n Equity n Shorten submission to award cycle

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

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

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

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

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

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

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