# Presentation: 265055

## PROGRAM DIRECTOR  ROLES AND RESPONSIBILITIES

- Barbara Spalholz, Ph.D.
- Division of Cancer Biology
- National Cancer Institute
- February 16, 2006

## Grant Process

- Pre-Application
- Referral
- Review
- Pre-Award
- Council
- Post-Award

- JAN    FEB    MAR    APR   MAY   JUN     JUL     AUG    SEP   OCT    NOV     DEC    JAN   FEB    MAR    APR    MAY    JUN     JUL

- Council

**Cycle**** ****1**

- Receipt

- Referral

- Award

- Application Submission TimeframeThree overlapping cycles occur per year:

## 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

## 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

## Grant Mechanism Experts

| Mechanism | Program Contact | OGA Expert* |
| --- | --- | --- |
| R13 
Conference  | David Contois, DEA | Penny Jones
Gerry McCann |
| R15 
AREA  | Chris Hatch, DEA | Joy Kearse |
| R21/R33 
Phased Innovation | Jennifer Couch,
DCB | Barbara Liesenfeld |
| R43,R44,R41,R42
SBIR,STTR | Michael Weingarten
OD | Ted Williams |
| Minority Supplements | Peter Ogunbiyi
CMBB | Barbara Fisher |

- * http://www3.cancer.gov/admin/gab/expert_list.pdf

## Data Sharing Plan

- Goal: “to share and make available to the public the results  and accomplishments of the activities that [NIH] funds”
- "unique data" that cannot be readily replicated eg., epidemiologic/clinical trial data, genome sequences/maps, protein/nucleotide databases
- Requirements:
- All applications requesting $500,000 DC or more in any single year.
- Guidelines:
- “Timely release and sharing“ of research results
- Applicants should explain any limitations in their data sharing plans
- Publishing final data is an acceptable mechanism for sharing data
- Data-sharing shouldn’t compromise research subjects' rights and privacy
- NCI Divisions developing specific guidelines for their portfolios
- Policy statement:
- http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
- Frequently Asked Questions on Data Sharing
- _[http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm](http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm)_

## Competing Renewal (T2) Budget Cap Policy

- NIH Guide announcement
- _[http://grants.nih.gov/grants/guide/notice-files/not-ca-01-016.html](http://grants.nih.gov/grants/guide/notice-files/not-ca-01-016.html)_
- Competing renewal can only request a 20% increase above their last funded year
- Can round up to nearest module
- Can include supplements in base if the work is continued in the renewal
- Exemptions
- Must be approved prior to application submission
- <30% increase, Division Director approval
- >30% increase, DDES approval
- Remediation after submission
- Applicants can withdraw application
- Applicants can possibly renegotiate aims before funding

## 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://](http://www.csr.nih.gov/review/irgdesc.htm)__[www.csr.nih.gov/review/irgdesc.htm](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
- http://cms.csrweb.nih.gov/PeerReviewResources/ReferralGuidelinesforFundingComponentsofPHS/

## NCI Referral Program Coordination and Referral Branch

- NCI Cancer Activity Referral Guidelines
- http://deaintranet.nci.nih.gov/ncipolicy/NCIInternalGuide03.pdf
- PCRB assigns applications to Cancer Activity
- 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

## 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

## Pre-Award: Funding Decisions

- PDs Should Not Make Funding Promises to PIs
- Funding Recommendation
- Within paylines (documented on paylists)
- Institute paylines
- Percentiled R01s, most R21s, R03s, R15s
- SBIRs, STTRs
- _[http://](http://camp.nci.nih.gov/admin/oem/efdb/)__[camp.nci.nih.gov/admin/oem/efdb](http://camp.nci.nih.gov/admin/oem/efdb/)__[/](http://camp.nci.nih.gov/admin/oem/efdb/)_
- EC determination
- P01s, R01s over $700,000 DC
- RFA, PA Funding plans
- Outside paylines-Discretionary Funding
- Accelerated Executive Review (AER)
- Exceptions/Shannons (R55) /R56s
- Documented on “Exception form” in Workbench Program Funding Request Module

## 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://](http://www.hhs.gov/ohrp)__[www.hhs.gov/ohrp](http://www.hhs.gov/ohrp)_
- Minority, Gender, Children - DEA policy _[http://](http://deaintranet.nci.nih.gov/ncipolicy/inclusion.htm#procedure)__[deaintranet.nci.nih.gov/ncipolicy/inclusion.htm#procedure](http://deaintranet.nci.nih.gov/ncipolicy/inclusion.htm#procedure)_
- Animal  - OLAW _[http://grants1.nih.gov/grants/olaw/olaw.htm](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

## Funding Preparation*Submit Documentation with Electronic Greensheet

- 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

## IRG and Funding Documentation: Responsibilities and Paper Flow

- Application Study Section Review
- 		1.CSR calculates score and prepares summary statement (SS)
- 		2.CSR releases to IMPAC II and NIH Commons
- 		3.PI is responsible for obtaining scores and SS from Commons

- _scored applications_
- 	Program sends NCAB information to PI

- _unscored applications_

- _to be funded - Program needs to:_
- 	1. Foreign grants - prepare 1820#*
- 	2. “U” codes # - contact PI to address concern, get code changed*
- 	3. Request and review updated other support*
- 	4. Request and obtain JIT*
- 	5. Complete electronic greensheet, append documents obtained
- 	6. Discretionary funding approval *-
- 		prepare exception, follow Division approval process

- _not to be funded:_
-          1. “U” codes –notify PI
-          2. advise on revising

- # = report to NCAB
- * = append to greensheet unless already in Commons

## 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](http://deaintranet.nci.nih.gov/ncipolicy/r37.htm)_
- Prepare Review Appeal Packages for Council Review
- Other Staff recommendations

## Slide 17

## 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

**Notes:**
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   

## 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)

## How to get access to databases

- DCB	Barbara Spalholz, John Cole
- DCCPS	Everett Carpenter, Judy Kuan
- DCP	David Levin, Cynthia Whitman
- DCTD	Wendy Fredericks
- DEA 	Greg Fischetti, Debbie Buranich
- OGA	Terry Dunne, Brian Iglesias
- EFDB	Sun Beng-Meng, Vance Hudgins
- OCTR	Pat Winkler
- Others	Anita LoMonico

- 2/24/05

## Program Director Resources

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

## Program Director Resources

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