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PROGRAM DIRECTOR ROLES AND RESPONSIBILITIES

Grant Process. Pre-ApplicationReferralReviewPre-Award CouncilPost-Award. . . JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL. . Review . Council. . Cycle 1. Receipt. Referral. . . . . . . . . Award. . . . . .

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PROGRAM DIRECTOR ROLES AND RESPONSIBILITIES

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    1. PROGRAM DIRECTOR ROLES AND RESPONSIBILITIES Barbara Spalholz, Ph.D. Division of Cancer Biology National Cancer Institute January 29, 2007

    2. Grant Process Pre-Application Referral Review Pre-Award Council Post-Award

    3. Application Submission Timeframe Three overlapping cycles occur per year:

    4. Pre-Application Program Activities: RFAs and PAs Develop scientific concepts for NCI initiatives Scientific community or portfolio based Advisory group directive Congressional directive Select appropriate grant mechanism and initiative mechanism to achieve goals R01, R21, R03, P01, U01 etc. Program Announcement (PA) Request for Applications (RFA) Obtain NCI approval Communicate goals of NCI initiatives ENS system - http://oerdb.od.nih.gov/cfdocs/ens/ens_main.cfm NIH Guide and Grants.gov Scientific community

    5. NCI Process to Initiate PAs, RFAs or RFPs

    6. Pre-Application Functions Advise applicants on funding mechanisms R01, P01, R15 etc. (unsolicited applications) R21, R03, R01 (PAs, RFAs) Other funding sources Prepare documents for applications requiring prior approval for acceptance Awaiting Receipt of Application (ARA) form Example: Applications over $500,000 dc in any year Workbench module Conference grants (POC is David Contois, DEA) http://grants2.nih.gov/grants/guide/pa-files/PAR-03-176.html Provide grant writing advice and study section information Advise on application procedures, requirements and general grant policy

    7. Application Requirements Competing Renewal Budget Cap http://grants.nih.gov/grants/guide/notice-files/not-ca-01-016.html Request is limited to a 20% increase above last funded year Exemptions must be approved before submission Model Organism Sharing Plan http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html Data Sharing Plan All applications requesting $500,000 DC or more in any single year. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html Goal: “to share and make available to the public the results and accomplishments of the activities that [NIH] funds” Plan to share "unique data" that cannot be readily replicated eg., epidemiologic/clinical trial data, genome sequences/maps, protein/nucleotide databases

    11. 2007 Grant Mechanism Experts

    12. CSR Referral Assignments are made based on specific written guidelines To Study Sections based on Topics addressed in the application Areas of expertise in the Study Section http://www.csr.nih.gov/review/irgdesc.htm To awarding Institute/Center based on Overall mission of the Institute/Center Specific programmatic mandates and interests of the Institute Dual assignments possible

    13. NCI Referral Program Coordination and Referral Branch PCRB assigns applications to Cancer Activity http://deaintranet.nci.nih.gov/ncipolicy/NCIInternalGuide03.pdf Assignment appears in Workbench Referral Activity lists Program reviews assignment Renewal/revised applications default to previous program Single referral: Program decides appropriateness Yes/ program accepts and assigns specific PD No/ program refers to another program/branch/IC If transferring primary IC assignment, prepares a 901 Dual NCI referral: Program representatives negotiate Refusing program releases application Accepting program assigns PD PD assignment transferred to IMPAC II systems PD name and contact information will appear of summary statement and NIH Commons

    14. Program Activities in the Initial Review Process Attend Study Sections Respond to Program Related Questions Note Reviewers’ Concerns Discuss Summary Statements and Issues Raised with Applicants Discuss Appeal Issues with SRAs

    15. Pre-Award: Funding Decisions PDs Should Not Make Funding Promises to PIs Payline funding Documented on Paylists in Workbench Institute paylines Percentiled R01s, R21s, R03s, R15s SBIRs, STTRs http://camp.nci.nih.gov/admin/oem/efdb/ EC determination P01s, R01s over $700,000 DC RFA, PA Funding plan Discretionary funding Documented on “Exception form” in Workbench Program Funding Request Module Exceptions/Shannons (R55) /R56s/AERs New PI “extended payline” Secondary IC assignments

    16. Resolving Human Subjects, Animal or Biohazard Concerns Examples of concerns: IRG identified H.S. code 44, 45 Animal code 44, 45 Program identifies concern from application or progress report Actions required before funding allowed Contact PI and obtain response Prepare recommendation and submit to appropriate office to lift bar to award Human Subjects Technical clarification - OER (Valerie Gordon) Assurance negotiation - OHRP http://www.hhs.gov/ohrp Minority, Gender, Children - DEA policy http://deaintranet.nci.nih.gov/ncipolicy/inclusion.htm#procedure Animal - OLAW http://grants1.nih.gov/grants/olaw/olaw.htm Biohazards – NIH OSHA http://dohs.ors.od.nih.gov/ Comments – PD reviews, contacts PI for response, and prepares recommendation

    17. Funding Preparation Fogarty Clearance for Foreign Grants and Domestic Grants with Substantial Foreign Components (Form 1820)* https://fts.nhlbi.nih.gov/nihfts/login.jsp Updated Other Support* Negotiate Overlap Concerns Negotiate Change in Aims to Match Budget Reductions Human and Animal Concerns Check Assurances – JIT information Resolve IRG Concerns* Check Required Human Subjects Training* Clinical Trials Special Requirements* Obtain Discretionary Funding Approval* Exception funding, budget restorations, policy exemptions NCI Levels of Authority Division-specific processes Complete Program Director Electronic Greensheet *Submit Documentation with Electronic Greensheet

    18. IRG and Funding Documentation: Responsibilities and Paper Flow

    19. Council Review-Program Activities National Cancer Advisory Board (NCAB) Report Review Concerns Human Subjects Women, Minorities and Children Representation Animal Welfare Biohazards Address Foreign Institution Requirements Prepare MERIT Nominations and Extension Recommendations http://deaintranet.nci.nih.gov/ncipolicy/r37.htm Prepare Review Appeal Packages for Council Review Other Staff recommendations

    21. Post-Award Activities Review Annual Non-competing Renewal Applications (T5) Accessible electronically in E-Grants Monitor Research Progress and Other Support Oversee Policy Adherence Assess Impact of Grant Changes Complete T5 Electronic Greensheet Assist Grantees During Award Period Evaluate Administrative Supplement Requests Explain Grant Policy Facilitate Collaborations This is the phase of the grant cycle where there is a close coordination between a program and grants management staff. 1. Provide direct consultation and assistance to grantees concerning programmatic and technical matters; Make sure there are no overlaps between projects; change in the scientific scope, change in PIs -Assist grantees by providing administrative supplements, interim funding, Follow the Levels of Authority, a document which was put forth by GAB. It provides us with a guideline as to which level has the authority to approve what. -So far, I have not mentioned much about our interactions with the ARCs. ARCs is involved with any activities that require the Division allocated funds, such as administrative supplements, exception funding, conference grants 3. Evaluate and Monitor progress -- PIs submit every year a progress report on their research and us as program director will read and evaluate the progress and ensure that there are no overlaps with their research; grantees should be acknowledging NCI grants in their publication 4. Interact and provide input to grants management staff concerning business issues relating to the grant I hope I have provided you with an overall picture as to what we as program director. Now I will turn over to Dianne Bronzert who will describe in detail some of the special program initiatives This is the phase of the grant cycle where there is a close coordination between a program and grants management staff. 1. Provide direct consultation and assistance to grantees concerning programmatic and technical matters; Make sure there are no overlaps between projects; change in the scientific scope, change in PIs -Assist grantees by providing administrative supplements, interim funding, Follow the Levels of Authority, a document which was put forth by GAB. It provides us with a guideline as to which level has the authority to approve what. -So far, I have not mentioned much about our interactions with the ARCs. ARCs is involved with any activities that require the Division allocated funds, such as administrative supplements, exception funding, conference grants 3. Evaluate and Monitor progress -- PIs submit every year a progress report on their research and us as program director will read and evaluate the progress and ensure that there are no overlaps with their research; grantees should be acknowledging NCI grants in their publication 4. Interact and provide input to grants management staff concerning business issues relating to the grant I hope I have provided you with an overall picture as to what we as program director. Now I will turn over to Dianne Bronzert who will describe in detail some of the special program initiatives

    22. Databases for Program Directors IMPAC II (NIH Information for Management, Analysis and Coordination) Requires IMPAC II userID and password http://impacii.nih.gov/webapps/index.cfm QuickView ? NIH Grant Folder ? PI Common’s View Program Module Electronic Council Book PMA (NCI Portfolio Management Application) Only available to subscribing NCI Divisions Workbench (NCI only) Requires NCI/Novell userID and password https://i2e.nci.nih.gov/workbench/WorkbenchView Notifications ? Greensheets YourGrants Referral Activity Program Funding Requests (Exceptions) Change IMPAC II password E-Grants (NCI Electronic Grant File)

    23. How to get access to databases DCB Barbara Spalholz, John Cole DCCPS Judy Kuan DCP David Levin, Cynthia Whitman DCTD Wendy Fredericks DEA Greg Fischetti, Debbie Buranich OGA Terry Dunne EFDB Sun Beng-Meng, Vance Hudgins OCTR Pat Winkler Others Anita LoMonico

    24. Program Director Resources NCI E-mail Distribution Lists Program Directors list owner is Charles Conley DEA PD Plus list owner is Charles Conley GAB (OGA) PD list contact Terry Dunne EFBD Program Staff list owner is Steve Hazen NOW (NCI Online Workplace) List Automatically included when you’re entered into NOW

    25. Program Director Resources Levels of Authority http://camp.nci.nih.gov/admin/grants/loaindex.htm Best Practices http://best-practices.cancer.gov/funding/ NCI Office of Grants Administration http://camp.nci.nih.gov/admin/grants/index.htm NCI Extramural Financial Data Branch http://camp.nci.nih.gov/admin/oem/efdb/ NCI DEA Intranet http://deaintranet.nci.nih.gov/ NIH Commons https://commons.era.nih.gov/commons/ Human Subjects Guidance http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf NCI Grants-Related Policies http://deaintranet.nci.nih.gov/ncipolicy/index.htm

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