receipt and referral of grant applications suzanne e. fisher, ph.d. director division of receipt and...

RECEIPT AND REFERRAL OF

GRANT APPLICATIONS

Suzanne E. Fisher, Ph.D.

Director

Division of Receipt and Referral

Center for Scientific Review

HACU 2006

Office of the DirectorOffice of the Director

National Instituteon Alcohol Abuseand Alcoholism

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National CancerInstitute

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Instituteof Environmental Health Sciences

National Instituteon Aging

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Child Health

and HumanDevelopment

National Institute onDeafness and Other

CommunicationDisorders

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National EyeInstitute

National HumanGenome Research

Institute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Instituteof Nursing Research

National Libraryof Medicine

National Libraryof Medicine

Center for InformationTechnology

Center for InformationTechnology



National Centerfor Complementary

and AlternativeMedicine

National Centerfor Complementary

and AlternativeMedicine

National Instituteof Allergy and

Infectious Diseases

National Instituteof Allergy and

Infectious Diseases

FogartyInternational

Center

FogartyInternational

Center

National Centerfor ResearchResources

National Centerfor ResearchResources

National Institutes of HealthNational Institutes of Health

Clinical Center

Clinical Center

National Center on Minority Health andHealth Disparities

National Center on Minority Health andHealth Disparities

National Institute of Biomedical Imagingand Bioengineering

National Institute of Biomedical Imagingand Bioengineering

In 2006 expect to receive nearly 80,000 applications

(paper and electronic)

TERMINOLOGY & ABBREVIATIONS

Assignment = Referral Institute/Center = IC Principal Investigator = PI FOA = Funding Opportunity Announcement

PA = Program Announcement RFA = Request for Applications

SRG = Scientific Review Group =Study Section = Review Committee

Grant Application Grant

TYPE OF APPLICATION DETERMINES SUBMISSION DATE

January, May September 10: Institutional Training Grant

February, June, October 1: New Research, Research Career, and all Program Project/Center

February, June, October 25: AREA March, July, November 1: Renewal/Competing

Continuation, Resubmission/Amended, and Revised/Supplemental

April, August, December 1: STTR and SBIR April, August, December 5: Individual NRSA

Fellowship April, August, December 15: Conference May, September 1, January 2: All AIDS applications

NEW LEXICONNew application = newRevised/amended application (A1, A2) =

resubmissionCompeting continuation application (type 2)

= renewalCompeting supplemental application (type

3) = revisionChanged/corrected application =

response to errors/warnings

Continuation = noncompeting continuation (type 5); do not use Grants.gov!

APPLICATION TYPE DETERMINES PAPER OR

ELECTRONIC SUBMISSION Conversion is by grant mechanism

Small Business – December 1, 2005 AREA (R15) – February 25, 2006 R03, R21, R33, R21/R33 R34 – June 1, 2006 R18, R25 – October 1, 2006 R01 – February 1, 2007 Career (K series) – June 1, 2007 Fellowships – August 5, 2007 All by October 2007

After conversion all applications (RFAs, PAs, PARs, PAs) must be submitted via Grants.gov; applications submitted in paper or using PHS 398 will not be accepted.

Mechanism Abbreviation Key:C06/UC6 Research Facilities Construction GrantsDP1 NIH Director’s Pioneer Award ProgramD71/U2R International Training Cooperative Agreement/ Phase 2 of FIC mechanism D71G Resource ProgramP Research Program Projects and CentersR01 Research Project Grant ProgramR03 Small Grant ProgramsR10/U10 Cooperative Clinical Research GrantsR13/U13 Support for Conferences & Scientific MeetingsR15 Academic Research Enhancement Awards (AREA)R18/U18 Research Demonstration and Dissemination Projects

R21/R33 Exploratory/Development ResearchR24/U24 Resource Related Research ProjectsR25 Education ProjectsR34 Clinical Trial Planning Grant ProgramR36 Research Dissertation Grant ProgramSBIR Small Business Innovation Research STTR Small Business Technology TransferS06,S10,S11 Biomedical ResearchS21,22 Health Disparities Endowment GrantsU Cooperative Agreement AwardsX01 High Throughput ScreeningX02 Preapplication

Current as of February 21, 2006. Visit the Web site for the latest version: http://era.nih.gov/ElectronicReceipt/

NIH Planned Transition Dates of Mechanisms for Electronic Submission using the SF424 (R&R)

2006

12 10 11

Resource (G7, G8, G11, G13, G20), Career Development (K), S11, S21, S22 (Jun. 1, 2007)

05 07 1209 01 02 03

R03,R21, R21/R33, R34(June 1, 2006)

04 05

2007

R18/U18, R25, C06/UC6 (Oct. 1, 2006) Fellowship (F)

(Aug. 5, 2007)

Project/Center (P), G12, M01, S06, R10/U10, U01, U19, U54, U56, R24/U24 (Oct. 1, 2007)

01 02 03 04 06 08 06

S10 (Mar. 22, 2006)

R15 (Feb. 25, 2006)

R36 (Feb. 17, 2006)

R13/U13 (Dec. 15, 2005)

SBIR/STTR (Dec. 1, 2005)

1007 0908

X02 (April 18, 2006)

R01(Feb. 1, 2007)

Training (T&D), U45, D71/U2R (Sep. 10, 2007)

Potential R01 Multi-PI Pilot(Oct. 1, 2006)

DP1(Jan. 22, 2007)

X01 (May 18, 2006)

ELECTRONIC SUBMISSION Grants.gov – single portal for applications to all Federal

Agencies eRA Commons – the NIH electronic Research

Administration system that allows applicants/grantees to electronically receive and transmit application and award information.

Registration is required in advance (may take 4 weeks) Grants.gov – Organization: DUNS and CCR NIH – Commons for organization and PI Start early and register now

Computer Requirements Pure Edge Viewer (free at Grants.gov) PDF generation PC or PC emulation software or CITRIX service (free)

ELECTRONIC SUBMISSION (cont.)

Start with Funding Opportunity Announcement (FOA) in the NIH Guide and Contracts (http://grants2.nih.gov/grants/guide/)

Combination of SF 424RR and PHS 398 specific elements (information on Principal Investigator, new investigators, clinical studies, Human Embryonic Stem Cells, etc.)

Submit to Grants.gov by 5 p.m. local time – limited validations

NIH retrieves application from Grants.gov – standard and mechanism specific validations

Utilize Commons to get information on validations – errors that must be corrected (starting at Grants.gov) and warnings (optional correction)

http://grants2.nih.gov/grants/guide/

Searching the NIH GuideThe NIH Guide for Grants and Contractshttp://grants2.nih.gov/grants/guide/index.html

Enter search criteria

orSelect Advanced Search

Searching the NIH Guide

Selecting the FOA number opens the announcement

Applicants will identify an FOA of interest and download the application package.


Button added to the NIH Guide announcements allows applicants to access the Grants.gov application package directly from the NIH Guide.


Download FOA instructions and applications package from Grants.gov

Preparing an Application

Select “Save” to save the application package to your local hard drive.All mandatory Grants.gov fields are high-lighted and denoted with an asterisk. See Application Guide for additional NIH requirements.


Optional documents may or may not need to be filled out – refer to the agency specific instructions

All Mandatory Documents must be completed in order to submit the application

NIH will use agency-specific forms labeled PHS 398


To open a form, highlight the form and then select “Open Form”

Preparing an Application Submit button

will not become activated until the following has been completed:•All Mandatory

Fields have been completed

•All Mandatory Documents have been completed and move to the Completed box

•All applicable Optional Documents have been completed and moved to the Completed box

•Only a AOR/SO can submit a grant!

Preparing Text Attachments

NIH only accepts attachments in PureEdge or PDF format. Do not submit attachments in other formats (Word, Word Perfect, etc.)

Do not put special characters in file names.

Disable all security features in the PDF document.

Do not send PDF documents with editable fields (fields that can be changed).

Check Submission Status in Commons

Once the application has been submitted, Grants.gov and eRA Commons will send a series of status Email notifications. Errors/Warnings Two business days to look at application; make sure

complete/correct. AOR only has option of rejecting Grants.gov sends notifications to the AOR only;

eRA Commons sends notifications to the AOR/SO and the PI.A full list of notification messages can be found at: http://era.nih.gov/ElectronicReceipt/tips_tools.htm#5.

Email can be unreliable – applicants should proactively check the status of their applications in eRA Commons after submission.

http://era.nih.gov/ElectronicReceipt/tips_tools.htm#TYPE%20OF%20APPLICATION%20DETERMINES%20SUBMISSION%20DATE

Viewing Errors/Warnings

1. Click the Status tab to view the PI Status.2. Find application that shows “eSubmission Error” in Application Status.3. Follow the link on the Application ID to see specific error/warning messages.

Application Errors/Warnings

Errors and Warnings Warnings can be fixed at the applicant’s

discretion but do not require action for the application to move on.

Errors must be addressed before the application can move on.

After making all corrections, the entire changed/corrected application must be resubmitted through Grants.gov.

Once all errors are corrected, a new grant image is generated and made available for checking.

PRACTICAL DETAILS -ELECTRONIC SUBMISSION Grants.gov/424RR applications look different

Some sections in more pages High quality images, color Form pages, organization a bit different

Best Advice – Read and follow all instructions! Most frequent mistakes

Not completing registration in advance Not allowing time for potential problems/corrections Omitting PI’s Commons User ID Attachments not in pdf format

While the mode of submission is changing the fundamental policies and processes of the NIH extramural process are not changing

Where To Go For Help General information on Electronic Submission/SF424

(R&R): http://era.nih.gov/ElectronicReceipt Grants.gov registration, submission and Pure Edge

questions: http://www.grants.gov/CustomerSupport Grants.gov Customer Service

• E-mail: [email protected] • Phone: 1-800-518-4726

eRA Commons registration and post submission questions

• http://era.nih.gov/commons/index.cfm • E-mail: [email protected] • Phone: 1-866-504-9552 OR 301-402-7469

Forms transition and questions on NIH’s plan for electronic receipt - NIH Grants Information

• E-mail: [email protected]• Phone: 301-435-0714

APPLICATION POLICIES Late Applications – Notice OD-05-030 IC approval needed for all applications requesting

$500,000 or more direct costs in any year Modular budgets for R01, R03, R15, R21, and R34

under $250,000 Resubmission Applications Applications to and following RFA Applications changing mechanisms Duplicate applications not allowed (P series exception) Format Requirements (within pdfs!):

Arial, Helvetica, Georgia, Palatino 11 point, 15 cpi, 6 lpi, ½ in margins Use common sense

RECENT CHANGES IN APPLICATION POLICIES Institutions now maintain record of PI signature; no need for PI to

sign paper application or verify electronic submission http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-054.html http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-055.html

Commons User Name required for all PIs Multiple PI option – contact PI, Leadership Plan; limited FOAs Effort reported in person months Include information on select agents when appropriate Appendix materials – use url for publicly available articles Changes in PHS 398:

http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-056.html Changes in SF 424RR: http://grants1.nih.gov/grants/guide/notice-files/NOT-

OD-06-057.html Changes in PHS 2590:

http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-058.htm l

WHAT KIND OF APPLICATION TO SUBMIT 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

INFORMATION SOURCES NIH Home Page (http://www.nih.gov)

Funding Opportunities/Grants Page: http://grants1.nih.gov/grants/oer.htm

NIH Guide to Grants and Contractshttp://grants2.nih.gov/grants/guide/index.html

Individual Institutes/Centers (http://www.nih.gov/icd/) Special Programs and Staff Contacts

Center for Scientific Review (http://www.csr.nih.gov) Descriptions of review groups Meeting schedule Review Guidelines Mock Study Section Contact Information

THREE COMPONENTS OF EACH ASSIGNMENT

Mechanism Institute/Center for funding consideration; dual

assignments based on IC interests Review location

Institute/Center CSR

Principal Investigators are encouraged to include a request letter. Institute/Center Review – IRG or Study Section Areas of Expertise Needed (but not names) Conflicts

MECHANISM

Different Institutes/Centers use different arrays of mechanisms

For some mechanisms (R03, R21, P series) ICs may have different eligibility criteria, budget caps, page limits for research plan, etc.

Paper - Identify PA/RFA on line 2 and mechanism in cover letter

Electronic – pick correct F0A

INSTITUTE/CENTER ASSIGNMENTS Referral Guidelines for Funding

Components of PHS ICs Have Many Shared Interests

Overall MissionSpecific Program Mandates24 Institutes/Centers have evolved over

time, many shared interests Principal Investigator Requests Institute/Center Requests Program Announcements Assignment History

INITIAL REVIEW GROUP ASSIGNMENT Referral Guidelines for IRG and Study Section

http://www.csr.nih.gov/review/irgdesc.htm Principal Investigator requests; generally show

application to requested IRG CSR practice is that if request cannot be honored,

accepting/welcoming IRG must communicate with PI. Previous assignment history IRG considerations:

Study Section or Special Emphasis Panel (SEP) Conflict of Interest Workload

PHILOSOPHY OF ASSIGNMENTS

Consider major focus of application – “center of gravity” Consider all aspects of application, not just title or

Description Review Guidelines are the fundamental basis of

decisions Guidelines cannot cover every topic Often consider secondary/tertiary factors

Panel on Scientific Boundaries for Review Basic science reviewed in context of organ/disease

studied Also need review location for fundamental science

studies Ideally have two “homes” for review for every

application

ASSIGNMENT NOTIFICATION

Study Section or Special Emphasis Panel Scientific Review Administrator

Address, telephone number, etc. Institute Assignment

Primary and any dual General contact number

Unique Identifier (1 R01 xx123456-01) Should receive within four to six weeks Utilize Commons to get assignment information, review

outcome; Summary Statements - NIH is phasing out paper notifications

Contact Division of Receipt and Referral if not available in Commons in a timely fashion!

ASSIGNMENT

Verify correct mechanism Concerns regarding review or Institute

assignmentContact SRAInstitute Home Page and telephone

number Request for change in writing to CSR (fax

301-480-1987) More efficient to include cover letter with

submission (electronic submission has cover letter option)

RESUBMISSION APPLICATION 2 amendment / No time limitation Must have received summary statement Need to make changes in Research

Plan Need to include Introduction and mark

text to show changes Next review may be by same or different

study section

THE NEXT STAGE

Peer Review

Questions?