NIH MODULAR GRANT APPLICATIONS: MODIFICATIONS AND UPDATE Release Date: July 24, 2000 NOTICE: OD-00-046 National Institutes of Health Since the original announcement by the National Institutes of Health in December 1998 of Modular Grant Applications, about 25,000 applications (R01, R03, R21, R15) have been submitted in the new modular format. We have received applications for four of the standard investigator-initiated rounds as well as many receipt dates for Request for Applications (RFAs) and Program Announcements (PAs). Throughout this period, we have received many questions/comments/concerns/inquiries to our e-mail address, and many hits to our modular grant website, As we now move to the full two-year phase of this new application format, there is a need to modify and clarify some of our original instructions and guidance to applicants and applicant institutions. This Notice addresses five issues regarding modular grant applications. A. MODIFICATIONS TO THE BUDGET NARRATIVE JUSTIFICATION PAGE Provide budget narrative for ALL personnel by position, role, and level of effort. This includes consultants and any to be appointed positions. Discussion: The original guidance requested budget narrative only for KEY personnel. We found the definition used to identify KEY personnel varied widely from Institution to Institution. Since personnel generally account for 65-70 percent of the direct costs of a grant award, providing a budget narrative for ALL personnel should be of great value to reviewers and NIH staff. In addition, this change will result in standard information for personnel in all applications. This modification is effective for all appropriate investigator-initiated applications and responses to RFAs and PAs submitted on or after September 1, 2000. RFAs and PAs released prior to September 1 will have contained our earlier reference to KEY personnel, but this notification will apply to them as well. In the future, all RFAs and PAs to be released will reference the requirement for ALL personnel to be discussed on the budget narrative page. B. CONSEQUENCES OF SUBMISSION OF NON-COMPLIANT MODULAR GRANT APPLICATIONS The modular grant application instructions require limited budgetary information and almost 95% of the applicants followed those instructions. Those applications that were not prepared according to the instructions have to date, been accepted for peer review. Administrative notes have been placed on summary statements to alert applicants of their failure to comply with the new application instructions. In order to ensure that all applications are treated in an equitable manner, the following new procedure is being implemented: Effective for the receipt dates beginning September 1, 2000, applications not in compliance with the modular application instructions will be returned to the applicant institution by the Center for Scientific Review. Applications revised and resubmitted to NIH in a timely manner may remain in the intended review cycle. An application will be considered NON-COMPLIANT if: 1. The requested direct cost budget is not in modules of $25,000 for all years of support for requests up to $250,000 per year. 2. A detailed itemized categorical budget is provided. 3. The Budget Narrative Justification page includes an itemized justification for one or more of the following: equipment, supplies, travel, other expenses, etc. but the number of modules requested in each year is the same, or the information is not intended to explain the request for a different number of modules in one or more years. 4. OTHER SUPPORT pages are supplied, in addition to or in the absence of the section in the Biographical Sketch identifying Research Projects Ongoing or Completed During the Last Three Years. 5. The Biographical Sketch lists Current and Pending Support instead of or in addition to the required information. C. UPDATE ON THE INITIAL PEER REVIEW OF MODULAR GRANT APPLICATIONS The first review cycle of modular grant applications generated a wide variety of opinions and reactions from applicants, reviewers, and Institutional sponsored research officials. Comments ranged from support and encouragement to serious concerns involving every aspect of the modular application process. In order to respond to these comments, a MODULAR GRANT APPLICATION UPDATE: PEER REVIEW was prepared and can be found at the Modular Grant website This update has been distributed to all Center for Scientific Review (CSR) review groups, appropriate Institute scientific review groups, and to all Scientific Review Administrators. It includes information on the review of modular applications with respect to how budget adjustments are to be recommended, overlap issues, preliminary data on the number of modules and direct costs requested, and most importantly, historical data on the pattern of direct cost awards for R01s by budget category. We are continuing to monitor all aspects of the process as this, the first full fiscal year of implementation comes to a close. D. CLARIFICATION TO THE CHECKLIST INSTRUCTIONS Applicant institutions should calculate the Facilities and Administrative(F&A) costs using the current negotiated F&A rate, less exclusions, for the initial budget period and all future budget periods. It is not necessary to list the exclusions on the Checklist nor anywhere in the application. E. REMINDERS FOR MODULAR GRANT APPLICATIONS 1. Budget Narrative Justification page this is not a Form page at this time. Use a blank sheet to recreate the sample. 2. Include a letter of commitment or intent if there is a subcontract/consortium. 3. Biosketches should be submitted for KEY personnel, including consultants. 4. Follow the guidance included in the PHS 398 instructions regarding page limitations and font size. 5. Any RFA or PA issued since December 1, 1998 that involves modular grant applications will state that fact. Any appropriate active PAs released before that time will also require submission in the modular format. 6. Reviewers will be instructed to disregard any budget or budget narrative justifications not in compliance with the modular application instructions.

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