NIH UpdateSpring 2005

University of North Carolina-Chapel Hill

Research Administration Support Group April 21, 2005

Current Issues

Reminders

Compliance

Electronic Research Administration

Outreach

Current IssuesCurrent Issues

Imperatives for NIH

• Accelerate pace of discoveries in life sciences• Enable deeper understanding of pathobiology of

disease prior to irreversible damage• Translate research more rapidly from laboratories to

patients and back• Explore novel biomedical strategies orders of

magnitude more effective than current ones• NIH Roadmap

What is the NIH Roadmap?

• A framework of priorities the NIH as a whole must address in order to optimize its entire research portfolio.

• A set of initiatives that are central to extending the quality of healthy life for people in this country and around the world.

• A vision for a more efficient and productive system of biomedical and behavioral research.

Three Themes of the Roadmap

Re-engineering theClinical Research

Enterprise

Research Teamsof the Future

New Pathwaysto Discovery

Re-engineering the Clinical Research

Enterprise

Public-PrivatePartnerships

High-riskResearch

Interdisciplinary Research Nanomedicine

Bioinformatics and Computational Biology

StructuralBiology

Building Blocks, Biological Pathways

and Networks

Molecular Libraries

and Imaging

ImplementationGroups

New Pathways to Discovery

Research Teams of the Future

Re-engineering the ClinicalEnterprise

NIH Roadmap: Trans-NIH teams manage…

New Pathways to DiscoveryGenomic era offers unprecedented opportunities

• Building Blocks for Biological Pathways, Networks

• Molecular Libraries and Imaging

• Structural Biology

• Bioinformatics and Computational Biology

• Nanomedicine

Research Teams of the FuturePromoting innovation

• Interdisciplinary Research Teams– Centers– Training

• “Out-of-the-Box” Thinkers– Director’s Pioneer Award

• Public-Private Partnerships– Central point of contact at NIH

Re-engineering the Clinical Research Enterprise

• Translational Research through:– Regional Centers– Core Services

• Harmonize and Simplify Clinical Research Regulatory Processes

• Integrate Clinical Research Networks• Strengthen Clinical Research Workforce

– Regional Centers of Excellence for Training– National Clinical Research Corps

NIH Roadmap Goals

• Accelerate basic research Accelerate basic research discoveries and speed translation discoveries and speed translation of those discoveries into clinical of those discoveries into clinical practicepractice

• Explicitly address roadblocks that Explicitly address roadblocks that slow the pace of medical slow the pace of medical research in improving the health research in improving the health of the American peopleof the American people

Additional Information on the NIH Roadmap

• Roadmap website:

http://nihroadmap.nih.gov/

• RFA’s and PA’s posted in the NIH Guide for Grants and Contracts

http://grants1.nih.gov/grants/guide/index.html

The NIH Budget

FY 2005 Budget $28.59 Billion

Research Project Grants

R&D Contracts

Intramural Research

All OtherRes. Mgmt. & Support

Other Research

Research Training

Research Centers

Research Project Grants 53%

$15.3 billionTraining 3% $761 million

FY ‘06 President’s Budget Request

• $28.740 billion – ~ .5% increase over FY 2005

• Approximately 9,463 competing RPG awards– ~ 247 over FY 2005

• Major initiatives– NIH Roadmap– Biodefense– Neuroscience Blueprint– AIDS

RPG Success Rates

NIH NIH RateRate

25%25% 16%16% 21%21% 18%18% 20%20% 2727%%

2929%%

2929%%

31%30%28%27%25%

32% 31% 32%

29%

31%

NIEHS RateNIEHS Rate 25% 19%

25% 25%

Salary Cap• Restricts the amount of direct salary under a grant

or contract to Executive Level I of the Federal Executive Pay Scale

• Executive Level I increase effective January 1, 2005

170,000

175,000

180,000

185,000

2004 2005

$175,700

$180,100

January 7, 2005 NIH Guide Noticehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-024.html

Public Access to NIH Research Information

New Public Access Policyto Publications Resulting from NIH-funded Research

NIH-funded investigators are requested to submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported, in whole or in part, with direct costs from NIH.

NIH Guide, February 3, 2005http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html

Effective May 2, 2005

Why Public Access?ACCESSACCESS Provide electronic access to NIH-funded research

publications for patients, families, health professionals, teachers, and students.

ARCHIVEARCHIVE Keep a central archive of NIH-funded research publications—for now and in the future, preserving vital medical research results and information for years to come.

ADVANCE SCIENCEADVANCE SCIENCE Create an information resource that will make it easier for scientists to mine medical research publications, and for NIH to better manage its entire research investment.

Updated Criteria for Evaluating Research Grant Applications

Updated Review CriteriaEffective Jan 2005

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Updated Review Criteria (cont)

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Updated Review Criteria (cont)

NIH Guide Notice, October 12, 2004 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-002.html

NIH Policy on Late Submission of Grant Applications

NIH Policy on Late Submission of Grant Applications

• NIH expects grant applications to be submitted on time • Late applications

– Generally are not accepted, except in rare instances• Unaccepted late applications will be returned without review

– Are only considered for standing receipt dates– Permission is not granted in advance– Must be accompanied by a cover letter with compelling reasons

for the delay – Window of consideration for late applications is two weeks

• NIH will not consider accepting late applications for the Special Receipt Dates for RFAs and PARs

NIH Guide, January 27, 2005http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-030.html

Model Organisms

New NIH Policy on Sharing of Model Organisms for Biomedical

Research

NIH Guide Notice, May 7, 2004 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html

FAQs and sample sharing plans available at: http://grants.nih.gov/grants/policy/model_organism/index.htm

Investigators submitting an NIH application/proposal beginning with the October 1, 2004 receipt date are expected to include a specific plan for sharing and distributing unique model organism research resources generated using NIH funding in the application/proposal OR state appropriate reasons for why such sharing is restricted or not possible.

Sharing Model Organisms (cont.)

• Applicants should specify– A reasonable time frame for periodic deposition of material

and associated data

– If, or how, they will exercise their intellectual property rights

• Investigators may request funds in their application/proposal to defray reasonable costs

• Reviewers will review the plan and may comment in an administrative note– Reviewers will generally not include their assessment in the

overall priority score.

• Failure to comply with NIH research resource sharing policies, guidelines, and the accepted plan may be considered by NIH staff in future funding decisions.

National Science Advisory Board for

Biosecurity (NSABB)

National Science Advisory Board for Biosecurity (NSABB)

• Will advise heads of Federal entities that conduct/support life sciences research

• Managed by NIH

• Further information and updates available at: http://www.biosecurityboard.gov

New Board to provide advice and guidance regarding biological research that has the potential for misuse and could pose a biologic threat to public health or national security

FY 2005 Kirschstein-NRSA News

FY 2005 Kirschstein-NRSA News

• $1,000 increase in Institutional Allowance for Individual Postdoctoral Fellowships only

• No stipend increase this year• Revising the Individual Fellowship Application and

Progress Report Form Pages and Instructions. Expect new version to be available by Fall 2005.

NIH Guide, February 4, 2005http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-032.html

Revised PHS 398 and 2590 Forms

• Revised PHS 398 forms are accepted for submission/receipt dates on or after 12/1/04.

• All applications received on or after May 10, 2005 must use the new instructions and forms.

• Applications using the old forms received after May 9 will be returned.

NIH Guide, November 2, 2004http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-006.htmlRevised instructions and forms http://grants.nih.gov/grants/forms.htm

PHS 398 (rev. 9/04)

PHS 398 (rev. 9/04)

Reorganized into 3 Parts– Part I: Instructions (now are truly just application

instructions)

– Part II: Supplement Instructions for Preparing the Human Subjects Section of the Research Plan

– Part III: Policies, Assurances, Definitions & Other Information

• Font Size Requirement: NIH now requires the use of Arial-11 or Helvetica-11 point font.

• Face Page: Added “Clinical Trials Indicator”.• Form Page 2

• Description now includes separate instruction for PI to clearly describe public health relevance.

• Created designated area for Stem Cell information.

• Added new section for “Other Significant Contributors”.

Changes of Note to the PHS 398 (rev. 9/04) Instructions

• Significant Revisions, particularly in Part II, Human Subjects Research Supplement, to address NIH implementation of OHRP Guidance on research involving coded private information or biological specimens.

• Instructions for Modular and Non-Modular Budgets and have been revised to implement the new policy on Direct Cost Limitations.

• The modular budget format no longer applies to SBIR/STTR grant applications.

Changes of Note to the PHS 398 (rev. 9/04) Instructions

Change in Calculation of Direct Costs for Applications with Consortium F&A Costs All applications that involve consortium/contractual facilities and administrative (F&A) costs are to exclude the facilities and administrative (F&A) costs requested by consortium participants from the total direct cost request.

NIH Guide notice, November 2, 2004: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html

Effective for all applications that

have submission/receipt dates

on or after Dec 1, 2004

New PHS 398 Modular Budget Format Page

BUDGET JUSTIFICATION PAGEMODULAR RESEARCH GRANT APPLICATION

Initial Period

2nd 3rd 4th 5th Sum Total

DC less Consortium F&A

(Item 7a, Face Page)

(Sum = Item 8a, Face Page)

Consortium F&A                              

Total DC                              

Total Direct Costs Requested for Entire Project Period$      

• Added 2 new rows (DC less Consortium F&A and Consortium F&A) and 1 new column (Sum Total)

New PHS 398 Budget Page - Form Page 4

• Separated Consortium DC & F&A Costs• Instructions revised to use Subtotal for Face

Page Item 7a

CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS     

SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (Item 7a, Face Page)$      

CONSORTIUM/CONTRACTUAL COSTSFACILITIES AND

ADMINISTRATIVE COSTS      

TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD $      

• Revised PHS 2590 forms may be used now• All progress reports received on or after May 1, 2005

must use the new version.

NIH Guide, November 2, 2004http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-007.htmlRevised instructions and forms http://grants.nih.gov/grants/forms.htm

PHS 2590 (rev. 9/04)

• Grantees need only submit a signed original and one copy.

• Uses new definition of “Key Personnel” implemented in the NIH Grants Policy Statement (rev. 12/03)

• “Other Significant Contributors” introduced in the PHS398 (rev. 9/04) has been incorporated

• The SNAP progress report instructions for the first 2 SNAP questions have been modified as follows:

– SNAP Question #1 - requires submission of complete Other Support information with any change

– SNAP Question #2, Reworded so level of effort question only applies to the PI and other personnel named on the Notice of Grant Award.

Changes of Note to the PHS 2590 Instructions

Centralized Receipt of Non-Competing Progress Reports

• Effective with non-competing progress reports due on/after October 1, 2004

• Does NOT change the mailing address used for all new and competing grants nor that process

• Only for NIH progress reports• Goal of improving efficiency

NIH Guide Notices, July 23 and September 2, 2004http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-054.htmlhttp://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-063.html

Applications and Forms:Questions?

Dedicated e-mail address for questions on format:

format@mail.nih.gov

Frequently asked questions on format:

http://www.format.nih.gov

New Grant Mechanism

New High Priority, Short-term Project Award (R56)

• Funding high-priority new or competing renewal R01 applications that fall just outside the funding limits of the participating NIH Institutes and Centers

• One or two years of funding • INVESTIGATORS MAY NOT APPLY FOR AN R56

GRANT - Recipients of R56 awards will be selected by IC staff

• Awarded beginning in Fiscal Year 2005• Additional information is available at

http://grants.nih.gov/grants/funding/r56.htm

NIH Guide, June 15, 2004http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-047.html

Career Development Awards

Mentored career awardees (K awardees) may now hold concurrent support from an NIH career

award and as a PI an NIH research grant or project leader on a multi-project grant.

Policy on Concurrent Support for Mentored Career Awardees

NIH Guide, November 14, 2003 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html

Information About Career Development Awardshttp://grants.nih.gov/training/careerdevelopmentawards.htm

• May reduce level of effort on career awards in last two years of support and replace with an NIH research grant or subproject -- awardee must remain in mentored situation

• Awardee must serve as a PI or subproject Director• Effort required on career award may be reduced to no less

than 50% and be replaced by effort from the research award so total level of research commitment remains at >75% for the duration of the mentored career award

• Applies to K01, K07, K08, K22, K23, and K25, and individuals mentored through institutional K12 awards

• Policy effective for competing research applications submitted on or after February 1, 2004

New Policy on Concurrent Support for Mentored Career Awardees

Revised Definition of Full Time Appointment for Career Awards

• Require 75% commitment of full-time professional effort• Revised policy allows recipient to meet required

commitment of total professional effort as long as:1. the individual has a full-time appointment with the

applicant organization

2. the minimum percentage of the candidate’s commitment required for the proposed Career award experience is covered by that appointment

• Applies to all existing Career Development Award announcements for all applications and resubmissions submitted on/after October 1, 2004

NIH Guide Notice, August 3, 2004http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html

SBIR/STTR(Small Business

Research)

SBIR/STTR• Use the "SBIR/STTR Supplementary Instructions for

Completing the Newly Revised (09/04) PHS 398 Forms• SBIR/STTR may no longer use modular budget format• FDA Resources and useful websites provided in

SBIR/STTR solicitation• Type 2 competing Phase II awards• NIH SBIR Conference in Bethesda, MD on July 28 &

29, 2005• Technical Assistance Program for NIH Awardees

NIH Small Business Funding Opportunities web page:http://grants.nih.gov/grants/funding/sbir.htm

Protecting Research Subjects

New Guidance for Protecting Research Subjects from Possible Harm Caused

by Financial Conflicts of Interest• New guidance entitled, "Financial Relationships and Interests

in Research Involving Human Subjects: Guidance for Human Subject Protection," published May 12, 2004

• Applies to all human subjects research conducted or supported by HHS agencies or regulated by the FDA

• Intended for:– Institutional Review Boards (IRBs)– Investigators– Research institutions– Other interested parties

Federal Register notice: http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finalguid.pdf

HHS press release: http://www.hhs.gov/news/press/2004pres/20040512.html

NIH Implementation of OHRP Guidanceon Research Involving Coded Private Information or Biological Specimens

• NIH added definitions and clarifications relevant to the OHRP Guidance to the PHS 398 (rev. 9/04) instructions.

• All grant applications and progress reports involving coded private information or biological specimens submitted on or after January 10, 2005 should follow the revised instructions.

• Although use of the 9/04 version of the PHS 398 is not mandatory until May 10, 2005, this version includes instructions to help applicants apply the OHRP guidance.

NIH Guide, December 30, 2004http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-020.htmlOHRP Guidance, August 10, 2004 http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf

RemindersReminders

Data Sharing

NIH Policy on Data Sharing

Investigators submitting a research application requesting $500,000 or more of direct costs in any single budget period to NIH on or after October 1, 2003 must include a plan for sharing final research data for research purposes, or state why data sharing is not possible.

February 26, 2003 NIH Guide Notice: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html

NIH Guide, October 16, 2001 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html

Reminder

Applications and Forms:Restriction on Submission

Prior approval is required for competingapplications that request $500,000 total direct costs or more for any budget period. (This limit is now exclusive of any consortium F&A costs.)

NIH Guide, October 16, 2001

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html

Reminder

Graduate Student Compensation

• Ties compensation on research grants to the zero level NRSA postdoc stipend in effect at the time of award

• Compensation continues to include “salary or

wages, fringe benefits and tuition remission”• No adjustments will be made to noncompeting award

levels or future years• Grantees may rebudget to accommodate the higher level• This policy was effective with awards issued on or after

12/10/2001

See NIH Guide, 12/10/2001 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-017.html

Reminder

Other Support

• NIH requires complete and up-to-date other support information before an award can be made– Complete means all sources of research support

(including outside the applicant organization)

• Grantees must report changes in other support as part of the annual progress report

NIH Guide, February 13, 2003http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-029.html

Reminder

Financial Conflict of Interest

See the following NIH Guide Notices for additional information:http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-00-040.htmlhttp://grants2.nih.gov/grants/guide/notice-files/not95-179.html

When a conflict of interest is identified, the grantee must:– Notify Chief GMO to assure that the conflict of

interest is being managed, reduced, or eliminated

– Provide additional information, if requested

FCOI requirements must be addressed in consortium agreements

Reminder

Closeout Final Reports

Documents are due within 90 days of project period end date– Final Financial Status Report (FSR)– Final Inventions Statement & Certification– Final Progress Report

Failure to submit timely reports may affect future funding to the organization

Reminder

Revised Policy on Amended Applications

• No longer time limit on submission of revised applications

• Limit of 2 revisions remains in effect

• Applies to all NIH extramural funding mechanisms

NIH Guide Notice May 7, 2003http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-041.html

Reminder

Revised Policy on Application Resubmissions

• Unfunded RFA applications--resubmit as NEW investigator initiated apps

• Previously unfunded investigator-initiated applications submitted in response to an RFA should be prepared as NEW applications

• Unfunded applications reviewed for a particular grant mechanism then submitted for a different grant mechanism--prepare as NEW applications

NIH Guide Notice, January 16, 2003:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html

Reminder

Non-Competing Continuation Progress Reports

• REMINDER—Don’t Be Late! A recent OIG study concluded that major contributing factors to late awards were late and/or incomplete progress reports.– An annual progress report is due two months

prior to anniversary date – New Business Process Beginning

10/1/2004: Centralized Receipt of ALL NIH Progress Reports: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-054.html

Non-competing Continuation Grant Progress Reports

• It is important that progress reports be complete and timely

• All grantees have access to searchable list of due progress reports at: http://era.nih.gov/userreports/pr_due.cfm

• NIH e-mails 2 progress report reminders to the PI– Two months prior to the due date– Two weeks after the due date for overdue reports

NIH Guide, August 5, 2003:http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-054.html

Reminder

Intellectual Property

• Implement Employee Agreements at employment• Disclose Each Invention within 60 days• Resolve Election or Waive of Title within 2 years • File Patent within 1 yr. of election• Provide License to the Govt. upon title election• Indicate Govt. Support on Patent with patent appl.• Share Royalties With Inventor when available• License Small Businesses where feasible• Product Manufacturing in U.S. required• Report on Invention Utilization annually

Invention Reporting Requirements of Invention Reporting Requirements of Grantee/Contractors per the Bayh-Grantee/Contractors per the Bayh-Dole ActDole ActAdministrative Requirements (per 37CFR, 401.14)Administrative Requirements (per 37CFR, 401.14)

Reminder

Intellectual Property

• Information on reporting requirements and policy, as well as electronic systems to fulfill reporting requirements, may be found at Interagency Edison, http://www.iedison.gov.

• All foreign grantees, contractors, consortium participants and/or subcontractors are reminded that they must comply with Bayh-Dole invention reporting requirements

COMPLIANCECOMPLIANCE

Common Institutional Compliance Issues• Misuse of funds• Unallowable costs• Misallocation of costs• Excessive cost transfers• Inaccurate effort reporting• Incomplete other support• Inadequate subrecipient monitoring• Large unobligated balances

Common Contributors to Compliance Problems

• Inadequate resources• Lack of understanding of roles and

responsibilities of institutional staff• Inadequate staff training and education• Outdated or nonexistent policies and

procedures• Inadequate management systems (e.g., effort

reporting, financial management)• Perception that internal control systems are

not necessary

What Can You Do?Elements of an Effective Compliance Program

• Formalized compliance function • Current, written policies and procedures• Defined roles and responsibilities• Ongoing training and education program• Effective communication• Effective management systems and internal

controls • Enforcement of compliance standards• Appropriate and prompt response to non-

compliance

eRA StatisticsNIH Commons

May ‘03 Jan. ‘04 Oct. ‘04 Feb. ‘05

Institutions 425 778 1,792 2,363

eSNAPs 165 756 2,944 5,174

FSRs 7,000 22,302 38,212 49,588

JIT N/A N/A 595 1,037

No Cost Ext. N/A N/A 2,961 4,012

Users 3,100 8,972 25,690 34,796

Commons Capabilities

• Administration– Create and maintain institutional profiles (IPFs)

– Create and maintain user accounts and professional profiles (PPFs)

• Status– Display summary and detail grant info, notice of

grant award and other documents, progress report face page, NIH staff contact info

– Link to study section dates and rosters

– Submit Just-in-Time (JIT) info

– Submit request for No-Cost Extension

Commons Capabilities (cont)

• Electronic Simple Non-Competing Award Process (eSNAP)– Review simple, non-competing grant info– Submit simple, non-competing progress report

• Financial Status Report (FSR)– Submit FSR

• Internet Assisted Review (IAR)– Submit critiques and scores prior to review meeting– Review all critiques prior to meeting– Generate summary statement body

• Demo Facility– Try out most Commons capabilities in a simulated session

Benefits of Electronic Submissions

• Just-in-Time Info– Enter IACUC and IRB approval dates, other

support and education info for key personnel involved with human subjects

• Request for No-Cost Extensions

– Automatically updates end dates

– Generates notifications

– Eliminates 10-day window for hardcopy requests

Benefits of Electronic Submissions (Cont)• eSNAPs

– Due 45 days before budget start date (vs. 60 days for paper)

– IRB and IACUC approval dates not required with submission

– Image stored in electronic grant folder for online viewing

• Reviewer Critiques– Laptops (PC and Mac) are easier to use than

paper at meetings– Reviewers come to the table prepared for

discussion, resulting in shorter and more productive meetings

– Study section chairperson/SRA creates better meeting schedule by knowing in advance which applications need the most discussion

– Electronic critiques facilitate the generation of summary statements

Update on Electronic Competing Application Process (eCGAP)

• More than 30 research institutions were early adopters during pilots

• In January 2005, NIH opened access to electronic submission for– modular non-consortia R01, R03 and R21

applications– new, competing continuation and revised

applications• Grantee institutions work with Service Providers

to transmit system-to-system

Collaboration with Grants.gov

• NIH Pioneer Award applications submitted via Grants.gov• eRA and Grants.gov completed initial system-to-system

tests• eRA and Grants.gov preparing for joint pilot in spring 2005• eRA mapped SF 424 R&R to eRA data elements• Grants.gov completing PHS 398 NIH-specific forms to

supplement SF 424• eRA defined business validations for applications thru

Grants.gov• eRA integrating Grants.gov Web service calls with eRA

eXchange

Why e-Applications• To satisfy the requirements of the Government Paperwork

Elimination Act (Public Law 105-277) as well as Public Law 106-107 and the President’s Management Agenda, which mandates improving access to federal grants via the Internet.

• To save 200,000,000 pieces of paper per year and countless hours of human effort. These savings mean more money and more time to dedicate to scientific discovery.

• To create a comprehensive electronic repository of eRA data that can be mined with intelligent tools to promote health research and accelerate discoveries.

OPDIV Integration with eRA• New DHHS Enterprise Grants Management System Board

oversees integration of all Department research grants processing under eRA.

• Benefits of Integration– streamline work processes to provide improved services to citizens– capitalize on existing advanced technology and best practices– create an opportunity for cost-effective, intra-agency sharing– provide a single point-of-interface with Grants.gov and the HHS

Unified Financial Management System– maintain reliable and common data across Operating Divisions– simplify the implementation of new policies and regulations

• Status of Migration (January 2005)- AHRQ is performing 100% of its research grant transactions using eRA; CDC, 95%; FDA, 30%, HRSA, 15%; and SAMHSA, 15%

Plans for 2005• Pilot e-applications with full budgets, supplements and

possibly addenda• Implement “One View,” to achieve a consistent look and

feel for data input, processing and reporting throughout the grant lifecycle

• Release new version of X-Train• Develop complex, electronic non-competing application

process (eNAP)• Create infrastructure for electronic notification• Implement organizational hierarchy, a new Commons

security scheme that will accommodate each institution’s unique structure (i.e., schools/divisions/departments) and the many roles/rights required by large institutions

Commons User SupportCommons User Support

eRA Website http://era.nih.gov/

Inside eRA for Partners Newsletter

http://era.nih.gov/eranews/backissue_partners.cfm

Commons Website https://commons.era.nih.gov/commons/

Commons Demos https://commonsdemo.era.nih.gov/commons-demo/

Commons Support Page

http://era.nih.gov/commons/index.cfm

Information for Partners

http://era.nih.gov/Projectmgmt/SBIR/sbir_grants.htm

Commons HelpDesk

Local Telephone 301-402-7469

Toll Free Telephone 866-504-9552

TTY Telephone (for Hearing Impaired Only)

301-451-5939

Email commons@od.nih.gov

Outreach and ResourcesOutreach and Resources

NIH Regional Seminars on Program Funding and Grants

Administration

• NIH holds 2 Regional Seminars a year to educate research administrators, investigators new to NIH, and trainees

• 2005 seminars: – April 7-8, 2005 in Albuquerque, NM

– June 23-24, 2005 in West Lafayette, IN

• Seminar information: http://grants.nih.gov/grants/seminars.htm

Workshops and Seminars:

http://grants1.nih.gov/grants/outreach.htm

Webpage for New Investigators

http://grants1.nih.gov/grants/new_investigators/index.htm

Grants Information

http://grants.nih.gov/grants/oer.htm

Phone: 301-435-0714

E-Mail: GrantsInfo@nih.gov

NIH Preserving public trust while

supporting discoveries to improve human health.

Dorothy Duke, Chief Grants Management Officer National Institute of Environmental Health Sciences

National Institutes of Healthduke3@niehs.nih.gov

Thank You!Thank You!

Questions?Questions?