NIH Update – Fall 2007
Office of Policy for Extramural Research
NIH Budget News
President’s Budget Request
• Requested $28.85
• Increase of $232 million
from FY2007 estimate
• Estimated 10,188
• Approx. 566 over
FY2007 estimates and
1000 more than FY2006
3 More at: http://officeofbudget.od.nih.gov/PDF/Press%20info-2008.pdf
President’s Budget Request
Areas of Focus:
– Bolster funding to new investigators especially in novel and
recently emerging areas of opportunity - Expansion of the
“Pathway to Independence” program
– Encourage established investigators through investigator-
initiated RPGs (FY2008 estimate is highest level in NIH
– Roadmap/Common Fund – Important for projects and
initiatives that accelerate the pace of discovery across NIH
– Global Fund for HIV/AIDS, Tuberculosis and Malaria
– Support studies of the Genes, Environment and Health
Initiative – Accelerate discovery of the major genetic factors
4 More at: http://officeofbudget.od.nih.gov/PDF/Press%20info-2008.pdf
FY 2008 President’s Budget Request
& Support 4%
All Other 5%
6% $15.165 B
Current NIH Budget Status
• Continuing Resolution (P.L. 110-92) funds NIH
and other agencies until November 16.
• NIH will issue non-competing research grant
awards at ~80% of previously committed level.
– Similar to FY2006 and FY2007
– Upward adjustments will be considered after final
appropriation is enacted.
• Institutions should monitor expenditures
carefully during this period.
6 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-001.html
NIH Award Data By State
(Data posted for FY 1998 – FY 2006)
NIH funding data for your Tennessee:
state and organizations FY 2006
within your state. Grants
Grant Type Dollar Amount
Just click on any location on this Construction $699,945 1
interactive map at Fellowships $2,500,429 57
Research Grants $395,265,874 941
Training Grants $16,343,557 55
Other Awards $789,507 3
Total $415,599,312 1057
Vanderbilt Univ. $268,470,667 5
Univ. of Memphis $5,572,280 9
7 More Award Trends at: http://grants.nih.gov/grants/award/awardtr.htm
NIH Ranking Tables Replaced
with New Web-Based Tool
Displays the dollars awarded by major component
or department, as well as by mechanism.
8 More at: http://grants.nih.gov/grants/award/trends/FindOrg.cfm
NIH Priority: Roadmap for
• “Version 1.5” Builds on Success of Original Roadmap
• NIH is Focusing on Three Roadmap “Themes”:
– Research Teams of the Future
– Re-engineering the Clinical Research Enterprise
– New Pathways to Discovery
• Building Blocks, Biological Pathways, and Networks
• Molecular Libraries and Imaging
• Structural Biology
• Bioinformatics and Computational Biology
• Human Microbiome Project – New in 2007!
• Epigenomics – New in 2007!
9 More at: http://nihroadmap.nih.gov
NIH Priority: Blueprint for
• Cooperative effort among 16 ICs to accelerate
• RFAs in 2007, 2008, and 2009 will focus on three
– Neurodegeneration during disease and aging;
– Neurodevelopment throughout the lifespan; and
– Neuroplasticity, from molecular to behavioral levels.
• Available neuroscience resources include: animal
models; imaging tools; neuroinformatics
(computational biology); core facilities; cells, tissue,
and DNA; gene and protein expression; and
10 More at: http://neuroscienceblueprint.nih.gov
NIH Priority: Continued Focus
on New Investigators
11 Available at: http://grants1.nih.gov/grants/new_investigators/index.htm
NIH/CSR Shortens Review
for New Investigators
• New investigators unsuccessful in a R01 grant submission who
are readily able to address the concerns and issues identified
in the Summary Statement may shorten the time to the next
• Available for all CSR study sections reviewing new investigator
R01 applications submitted for standard receipt dates (not
including RFAs and PARs with special dates).
• Policies and practices include:
– Resubmission applications to be considered at the next
cycle must be submitted by March 20, July 20, or November
– New Investigators who do not choose this option may use
the standard resubmission dates for subsequent
submissions (March 5, July 5, or November 5).
12 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html
New Innovator Award (DP2)
• Stimulates highly innovative research.
• Supports promising new investigators.
• Awards will provide up to $1.5 million in direct
costs for (up to) a 5 year project period.
• Highly Popular: NIH received nearly 2,200
• Currently reviewing lessons-learned for future
13 More at: http://grants.nih.gov/grants/new_investigators/innovator_award
Pathway to Independence
• Facilitates timely transition from mentored postdoctoral
research to independent research position at earlier stage.
• Primary, long-term goal is to increase and maintain strong
cohort of new and talented, NIH-supported independent
• Provides up to 5 years of support consisting of two phases:
– Initial phase (K99): 1-2 years of mentored support for
highly promising, postdoctoral research scientists.
– 2nd Phase (R00): Up to 3 years of independent support
contingent on securing an independent research position.
• Standard K Submission Dates (February 12, June 12,
• Program Announcement PA-07-297
14 Qs and As at: http://grants.nih.gov/grants/new_investigators/QsandAs.htm
NIH Director’s Bridge Award
• Continued, limited funding for new and established PIs who
have submitted a competing renewal, who just miss the
nominal funding payline for the IC.
• Additional funded time for PIs to strengthen a resubmission.
• Selectees receive one-year of funding up to $333,000 DC +
• Cannot apply, cannot self-nominate! Criteria:
– Must have < $200,000 in other support (total costs) from
all sources to fund research
– No A2s are eligible
– Applications submitted in FY2006 that are still being
considered for funding & FY2007 submissions
15 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-056.html
New Scientific and Grants
Enhancing Peer Review at NIH
• Reviewing strengths and deficiencies of NIH peer review
• Especially interested in creative suggestions regarding:
– Challenges of NIH System of Research Support
– Challenges of Peer Review Process
– Solutions to Challenges
– Core Values of NIH Peer Review Process
– Peer Review Criteria and Scoring
– Career Pathways
• Public Consultation Period
– Regional Consultation Meetings held September/October,
– RFI for public comment period in Summer, 2007
17 More at: http://enhancing-peer-review.nih.gov
Centralized NIH Database
of Human Genome Data
• Facilitates rapid and broad access to Genome-Wide
Association Study (GWAS) datasets
• Policy addresses:
– Principles governing the repository
– Data sharing procedures and requirements
– Research participant protection and privacy
– Data Access Committees
– Intellectual property and publication rights
– Oversight and governance of repository
• Policy effective for applicants submitting 1/25/08
18 GWAS Website: http://grants.nih.gov/grants/gwas
Multiple Principal Investigators
Supporting Team Science
Goal: Encourage collaboration among equals
when that is the most appropriate way to
address a scientific problem, a “Team
Multiple Principal Investigator website and FAQs:
• Available to all research grant applications
submitted electronically through Grants.gov.
• Does not apply to the following types of
applications (Note: The restriction to a single PI
will be described in FOAs for those programs.)
– Individual Career Awards, Fellowships,
Dissertation Grants, Director‟s Pioneer Awards,
Construction Grants, and Shared
• Some PHS 398 applications submitted on paper
will allow inclusion of multiple PIs, but only when
clearly specified in the RFA or PA.
20 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html
Limits on Application
• Applicants often ask, “What constitutes a New
– Substantially different in content and scope
– Includes substantial changes in all sections of the
– Includes fundamental changes in the questions being
asked and/or the outcomes examined
– Requests for review by a different review committee or
funding consideration by a different NIH institute are not
sufficient reasons to consider an application as new.
• Resubmission FAQs:
21 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-015.html
Funding Policy for NRSA
• FY2008 Update: No changes to levels announced
• Institutional Training Grants (T32, T34, T35,
– Effective for new & competing renewals beginning in
FY 2007, and non-competing awards in FY 2007 that
were awarded as competing in FY 2006
– Tuition & Fees: Formula provides 60% of the level
requested by the applicant institution up to a specified
– Training Related Expenses: Funds per trainee
increased and includes health insurance.
22 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-057.html
NRSA Pilot: Funding Policy
for NRSA (Cont.)
• Individual Fellowships (F30, F31, F32, F33,
– Effective for awards beginning in FY 2007
– Tuition & Fees: New formula provides 60% of the
level requested by the applicant institution up to a
– Institutional Allowance: Funds provided per fellow
increased and includes health insurance.
23 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-057.html
Institutional Training Grants
Institutional Training Grants
Award PREDOCTORAL POSTDOCTORAL
OLD NEW OLD NEW
Stipend $20,772 $20,772 $36,996 - $51,036 $36,996 - $51,036
Tuition/Fee $3,000 + 60% 60% up to $3,000 + 60% above 60% up to $4,500
above $3,000 $16,000 $3,000 (includes 60% up to $16,000
(includes 60% up to health insurance) for additional
health $21,000 for dual degree
Training $2,200 $4,200 $3,850 $7,850
Related (includes health (includes health
Expenses insurance) insurance)
Trainee $400 - $1,000 (typical range; varies by NIH awarding component)
F&A (Old) 8% (excludes tuition/fees/health insurance, equipment)
F&A (New) 8% (excludes, tuition/fees, equipment)
Award PREDOCTORAL POSTDOCTORAL
OLD NEW OLD NEW
Stipend $20,772 $20,772 $36,996 - $36,996 -
Tuition/Fees $3,000 + 60% 60% up to $3,000 + 60% 60% up to
above $3,000 $16,000 above $3,000 $4,500
(includes 60% up to (does not 60% up to
health $21,000 for include health $16,000 for
insurance) dual degree insurance) additional
Institutional $2,750* $4,200* $7,000* $7,850*
Allowance $1,650** $3,100** $5,900** $6,750**
(includes (includes health (includes health
health insurance) insurance)
Current NIH Salary Cap
• Effective January 1, 2007, salary and wages on
NIH grants limited to $186,600.
• Stay tuned for FY 2008 cap requirements.
• Grantees should provide information on full
salary needs (if more than the cap) so NIH can
adjust based on future limits.
• Salary Cap Summary (Historical Information):
26 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-051.html
New: Notice of Award (NoA)
• Now a PDF attachment to an e-mail (no longer
• Improves formatting and function (long terms
can now be accommodated)
• Summary & cumulative data provided when a
separate supplement award has been issued
• E-mailed to address designated in eRA
• NIH is working to eliminate hard copy mailing of
27 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-060.html
Elimination of Paper Notification of
Award Letters (NoAs)
• As of January 1, 2008, NIH will no longer
provide paper notification of NoA letters.
• NoAs will be sent solely by e-mail and award
letters will be accessible through the eRA
• All award recipients must be e-mail enabled!
– Edit your institutional profile in the eRA
– If already enabled, confirm that the address is
28 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-002.html
• As of October 1, 2007, NIH requires all
Financial Status Reports (FSRs) to be
submitted using the electronic FSR
system in the eRA Commons.
• Applies to both domestic and foreign
• Does not apply to other Federal
29 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-078.html
Federal Funding Accountability
and Transparency Act (FFATA)
• NIH is actively involved with a variety of Federal-
wide committees to implement the act and is
tailoring processes to meet its requirements.
• Federal Funding Accountability and Transparency
Act (P.L. 109-282) requires reporting of all
subrecipient awards above $25,000.
– Requires information on every grant, including 1) the
amount, 2) descriptive purpose of the grant, and 3) name
and location of recipient of primary performance location.
– Potential increased attention and scrutiny when data is
made publicly available.
30 More at: www.FederalSpending.gov
Highlights of New and
Existing Grant Requirements
Financial Conflict of Interest
• Targeted Site Reviews were a 2006 to determine whether
grantee institutions have:
– Fully implemented the FCOI regulations as they pertain to
grants (42 CFR Part 50 Subpart F), and;
– Complied with reporting requirements.
• Eighteen site reviews completed in FY 2006
– “Observations from NIH‟s FY 2006 Targeted Site Reviews
on Financial Conflict of Interest” have been posted on the
OER Conflict of Interest page:
– Guide Notice: http://grants.nih.gov/grants/guide/notice-
32 FCOI questions for NIH? FCOIcompliance@mail.nih.gov
Definition of Investigator
Investigator – Principal Investigator (PI) and any other
person who is responsible for the design, conduct, or
reporting of research funded by PHS, or proposed for such
The term “Investigator” includes the Investigator’s spouse
and dependent children.
• An investigator is not just the Principal Investigator or Key
Personnel conducting the PHS sponsored research.
• Recipient institutions are encouraged to broadly consider
an individual‟s role, rather than title, and their degree of
independence when applying the definition.
FCOI Summary of
1. At the time of application: Investigators must
submit significant financial interests to the
2. Prior to the expenditure of funds: The
institution must report a financial conflict of
interest to the NIH and assure that it has been
managed, reduced, or eliminated.
3. FCOI identified after the initial report: The
institution must report within 60 days of
identification and assure that it has been
managed, reduced, or eliminated.
34 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-013.html
Protecting Research Subjects
Protecting Research Subjects from Harm Caused by
Financial Conflicts of Interest
• 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)
– Research institutions
– Other interested parties
35 More at: http://www.hhs.gov/news/press/2004pres/20040512.html
Pilot FCOI Compliance Program
• NIH will select a number of institutions for review of
their FCOI policy and related information.
– Based on 42 CFR Part 50, Subpart F: Responsibility of
Applicants for Promoting Objectivity in Research for
which PHS Funding is Sought
– These are desk reviews, not site visits
– Areas of noncompliance will be noted and must be
resolved with the NIH Division of Grants Compliance
• Results of the pilot program will be shared with the
NIH research community for educational purposes
to enhance and improve FCOI compliance.
36 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-010.html
FY 2008 OIG Audit Work Plan
• Colleges‟ and Universities‟ Compliance with Cost
– May include cost transfers, effort reporting, and other
areas in OMB Circular A-21.
• University Administrative and Clerical Salaries
– Are salary costs appropriately charged?
• NIH Monitoring of Extramural Conflicts of Interest
– How NIH monitors extramural grantees‟ financial conflicts
of interest and the effectiveness of NIH‟s oversight.
37 FY 08 Work Plan: http://oig.hhs.gov/publications/workplan.html#1
• All NIH grantees that expend $500,000 or
more within a year in Federal awards are
subject to an audit requirement.
• Audits are due no later than 9 months after
the end of the grantee‟s audit period.
• Grantees delinquent in submitting audits risk
the imposition of sanctions and potential loss
of Federal funds.
Summary of Audit Requirements
Grantee Type Source of Audit Where to Submit Audit Reports
State & Local OMB Circular A-133 Federal Audit Clearinghouse
Governments 1201 E. 10th Street
Colleges & Jeffersonville, IN 47132
National External Audit Review Center
For-Profits HHS Office of Audit Services
45 CFR Part 74.26 (d) 323 West 8th Street
Lucas Place, Room 514
Kansas City, MO 64105
Foreign NIH Grants Policy
Statement (same as (same as For-Profits)
• Policy 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 are made to noncompeting award
levels or future years.
• Grantees may rebudget to accommodate higher
level of postdoc stipend in subsequent years.
40 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-017.html
Closeout Final Reports
Grantees are strongly encouraged to submit closeout
documents electronically through the eRA Commons!
• Documents are due within 90 days of
project period end date
– Final Financial Status Report (now required
– Final Inventions Statement & Certification
– Final Progress Report
• Failure to submit timely reports may
affect future funding to the organization!
41 More at:http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-051.htm/
NIH Policy on Data Sharing
submitting a research
$500,000 or more of
direct costs, in any
single budget period
to NIH, must include a
plan for sharing final
research data for
research purposes, or
state why data sharing
is not possible.
NIH Policy on Data Sharing
• Data Sharing Main Page http://grants.nih.gov/grants/policy/data_sharing
• Data Sharing Chart: Quick guide for the purpose of identifying
various data sharing regulation/policy/guidance documents
applicable to NIH funding
• NIH Guide Notice, 2/26/03: Final NIH Statement on Sharing
Research Data http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-
• NIH Guide Notice,10/16/01: Revised Policy on the
Acceptance for Review of Unsolicited Applications that
Request $500,000 or More in Direct Costs
NIH Policy on Sharing of Model
Organisms for Biomedical Research
Investigators submitting an NIH
application/proposal 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.
FAQs and sample sharing plans available at:
44 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html
Animal Welfare Requirements
and Compliance Assistance
• “What Investigators Need to Know About the Care and Use of
– Brochure explains the requirements for using animals in
– Contact OLAW to request multiple copies
• FAQs on “PHS Policy on Humane Care and Use of
Vertebrate Animals” available on the OLAW website
• IACUC 101 is a series of workshops on the roles and
responsibilities of IACUCs, including federal policies and
regulations regarding animal welfare.
– November 29, 2007: Virginia Beach, VA
– March 26, 2008: Atlanta, GA
46 More at: http://olaw.nih.gov
Policy on UnAllowable Costs for
Activities Involving Animals
• Institutions are not permitted to charge grants or
contracts for animal activities when terms and
conditions are not upheld, e.g.,
– Absence/suspension of valid Assurance filed with OLAW
– Absence/suspension of valid IACUC approval of the animal
• Failure to obtain IACUC approval for animal activity.
• Continuing animal activities after IACUC approval has expired.
• Continuing animal activities after suspension of IACUC approval.
• Institutions must report noncompliant situations to:
– OLAW (firstname.lastname@example.org or 301-594-2061)
– Institute/Center (IC) supporting the award
47 More at: Notice NOT-OD-07-044 at http://olaw.nih.gov
Subawards and Animals (Cont.)
• Prime grantee is accountable to NIH and must confirm
Assurance and IACUC approval (dated within 3 years)
• Animal welfare requirements apply to all consortium
participants and sub-projects
– Inter-Institutional Assurance is needed:
• Prime grantee has no animal program; animal work is
being conducted at an Assured performance site
– Foreign Assurance is needed:
• Direct support to a foreign institution
• Domestic prime grantee with a foreign performance
site using animals (Domestic grantee‟s IACUC
approves animal activities performed at foreign site)
48 GPS Page 224 at: http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
Electronic Submission Status
• 80% of all competing grant
applications to NIH are now
• NIH continues to account for over
50% of all application submissions
• Career Development (K) Transitions
• Fellowship (F) to electronic
• Training & Development (T&D) submission
• Complex mechanisms
– NIH, AHRQ and Grants.gov are working together to
establish new transition dates. A notice announcing the
adjusted timeline will be issued as soon as possible.
– For now, applications for these mechanisms will continue
to be submitted on paper using the applicable forms.
Read & Follow All Instructions!
• Avoid having to submit corrected
applications – read and follow all
application guide and
– Look for the HHS logo in the
application guide for any special
instructions or fields not marked as
mandatory on the federal-wide
form that are required by NIH
52 More at: http://grants.nih.gov/grants/funding/424/index.htm
Avoid Common Errors
• Use PDF format for text attachments
• R&R Senior/Key Person Profile(s) form
– Include eRA Commons Username in the
“Credential, e.g. agency login” field for all
individuals assigned a PD/PI role.
– Include the Organization Name for all Senior/Key
• R&R Budget form - Senior/Key Person effort
must be greater than zero
53 More at: http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm
Track Your Application
• Clicking “Submit” is NOT the last step!
– It is the applicant‟s responsibility to track the
application through the submission process
– Use eRA Commons to check for submission
errors/warnings and to view your assembled
• If you can‟t view your application in eRA
Commons – we can‟t review it!
54 More at: http://era.nih.gov/ElectronicReceipt/
• Responded to applicant
– Improved text of error/warning
– Enhanced application guide
– Extended application viewing
times through Federal holidays
55 More at: http://era.nih.gov/ElectronicReceipt/
• Grants.gov Adobe eForms
– Platform Independent
(PC and Mac compatible)
– Advanced Search Features
– Will have the same „look & feel‟ as current
forms to ease the transition
– No firm transition date set
• Reduction of correction window in ERA
Commons from 5 days to 2 days.
56 More at: http://www.grants.gov/aboutgrants/program_status.jsp
Servicing Other Agencies
• Continuing to service HHS partners
– Agency for Healthcare Research & Quality (AHRQ)
– Centers for Disease Control and Prevention (CDC)
– Food & Drug Administration (FDA)
– Substance Abuse & Mental Health Services
• New partner
– Veteran‟s Health Administration (VA)
• Summer 2007 pilot
eRA Commons Features
• Electronic Streamlined Non-competing Award
– Changes to Institutional Profile
– Updated to include changes to multi-PI Leadership
Plan and research with Select Agents
• Delegation of PI status to assistant for
reviewing electronic applications
• Ability to monitor the electronic submission of
59 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-064.html
Coming Soon: xTrain
• xTrain is a new system to improve the
administration of NIH Training Grants.
– Allows PIs and staff to electronically submit
appointment forms and termination notices
– Allows institutional staff to track status and timing
of appointment actions
– Will be available through eRA Commons
• Pilot - Fall 2007
• Full production release – Expected early 2008
Enhanced eRA Commons
• Updated Status screens (October 26, 2007).
– Added ability to search and track applications by
Grants.gov tracking number.
– Reorganized application/grant data to separate
applications requiring further action in the
submission process from all others.
• While the screens may look different, all the
information you’re used to seeing is still
available (plus more!)
61 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-007.html
• PIs have an obligation to keep information in
their Personal Profile current and need to
update it regularly
• Profile data used in other electronic
processes (e.g., Summary Statements,
– Position Titles
– Addresses - e-mail & postal
Technical Assistance and
Pipeline to Partnerships
• Showcase of SBIR/STTR grantee technology
available to potential strategic partners and
investors for development opportunities.
• Searchable index organized by technology and
stage of development.
65 More at: http://www.ott.nih.gov/p2p/p2p_writeup.html/
Redesigned OER Web Site
• Office of Extramural Research home page
– Links to funding opportunities, grants policy,
application and forms, awarded grant data
• Redesign based on focus groups and visitor
– New search tools
– Comprehensive glossary and acronyms list
– New content walks through the NIH grant-
• Also improved & updated eRA web site
66 Visit at: http://grants.nih.gov/grants/oer.htm
67 OER web site located at http://grants.nih.gov/grants/oer.htm
Redesigned eRA Web Site
• Services for Applicants - 'plain language' fact
sheets on eRA services
• Commons - overview, quick link to system,
user guides, release notes, FAQs and other
• NIH & Grantor Agencies - highlights services
and system modules available for NIH staff and
other Federal agencies
• News & Events - eRA updates and info on
68 Visit at: http://era.nih.gov/
Helpful NIH Web Pages
• NIH Searchable Database of RFAs, PAs, and Guide Notices
• NIH Grants Policy Statement (Rev. 12/03)
• NIH Extramural Nexus – Bimonthly newsletter for the extramural
• Electronic Submission of Grant Applications Homepage
• CRISP database - Search to analyze an Institute‟s portfolio of
funded projects, research areas, and more
• Grant Application Basics
New OER Outreach Webpage
New OER Outreach Webpage
• NIH Regional Seminars on Program Funding and Grants
– Funding Opportunities for New Investigators
– Application Preparation and the Review Process
– Grant Administration Issues, Hot Topics, and More…
• National Animal Welfare Workshops
• Office of Human Research Protections Workshops
• NIH Small Business Research Workshops
• Office of Research Integrity Workshops and Conferences
70 Visit at: http://grants.nih.gov/grants/outreach.htm
NIH Regional Seminars on Program
Funding and Grants Administration
2008 Regional Seminars:
March 25-26, 2008 in San Antonio, TX
June 19-20, 2008 in Chicago, IL
NIH electronic research administration labs
offered in conjunction with the two-day seminar.
• Yearly seminars to educate research administrators,
investigators new to NIH, and trainees.
• Due to the popularity of these seminars and availability
of space - Early Registration is Highly
Recommended! Interested in hosting?
• Seminar and Registration Information: Contact us!
71 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-076.html
NIH OER Listserv Addresses
• Office of Biotechnology Activities (OBA):
• Office of Human Research Protections (OHRP):
• Office of Laboratory Animal Welfare (OLAW):
– Separate listservs available for scientists and administrators
• NIH Guide for Grants and Contracts:
– The official publication for NIH medical and behavioral research
Grant Policies, Guidelines and Funding Opportunities
Who to Contact!
• Institutional Resources – First, utilize the
expertise of your organization‟s Office of
Application Specific Questions
• Administrative - Contact the Grants Management
Specialist at the awarding Institute/Center
• Scientific/Programmatic - Contact the designated
Program Official/Director at awarding
• Review Questions - Contact the assigned
Scientific Review Officer
Who to Contact!
• Grants Administration individuals at all NIH ICs:
• NIH Chief Grants Management Officers:
• Grants Policy Interpretation & Consultation:
– E-Mail: GrantsPolicy@mail.nih.gov
– Phone: 301-435-0949 Toll-Free at (800) 518-4726
• Compliance Issues:
– E-Mail: GrantsCompliance@mail.nih.gov
– Phone: 301-435-0949 Toll-Free at (800) 518-4726
Who to Contact!
• General Application Questions: (e-Submission guidelines,
resources & referrals, application review & award process,
– E-Mail: GrantsInfo@nih.gov
– Phone: 301-435-0714
• Customer Support for Grants.gov: (navigating forms, aspects
of submitting through the system, resources available, etc.)
– E-Mail: email@example.com
– Webpage: http://grants.gov/
– Phone: 1-800-518-4726
• eRA Commons Help Desk: (Commons registration help,
application verification, Commons functionality questions, etc.)
– E-Mail: firstname.lastname@example.org
– Webpage: https://commons.era.nih.gov/commons/index.jsp
– Phone: 301-402-7469 (Toll Free: 866-504-9552)
#1 – How do I prepare for
• Grants.gov requires registration for the
• eRA Commons registration is for both the
organization and the PI
– These are separate processes that can be done
• All registrations must be completed prior to
It is critical for institutions to begin these registrations
at least 2 – 4 weeks before applications are due!
78 More at: http://era.nih.gov/ElectronicReceipt/preparing.htm
#2 – How do I submit a
– NIH Grant Applications Forms (PHS 398 and SF424 R&R) accommodate
more than one PI
– Leadership Plan required describing roles, responsibilities, and the working
relationship of the identified PIs.
• Principal Investigators
– The Contact PI will be responsible for communication between the NIH and
the leadership team (and will be listed first on the application)
– All PIs share the responsibility and authority for leading and directing the
• New Investigator Policies
– New Investigator box on the application may only be checked when all PIs
are classified as New Investigators.
• Review Criteria
– Standard NIH review criteria have been modified accordingly.
• Awards Involving More than One Institution
– PIs from different institutions will be managed though subcontracts for now.
79 More at: http://grants.nih.gov/grants/multi_pi/
#3 – Are there any fellowship programs for
individuals from minority or disadvantaged
Yes, but a revised FOA includes the
• Effective January 1, 2007: Now 3 submission
dates--April 13, August 13, and December 13.
• Amends application submission requirements.
Specifically, adds new bullet in “Content and Form
of Application Submission” section to require
information that must be submitted by applicant
Institution in a letter certifying the applicant‟s
eligibility (See FOA for further details.)
• Updates information on Tuition/Fees and
Institutional Allowance, published in the NIH
80 FOA at: http://grants.nih.gov/grants/guide/pa-files/PA-07-106.html
#4 - Does NIH still accept
unsolicited grant applications?
Yes, by using Parent Announcements
– Used for “unsolicited” or “investigator-initiated”
– Available on Grants.gov and NIH web pages.
• Program Announcements
– Statement of new or ongoing NIH interest in a
certain research area.
• Requests for Applications (RFAs)
– Statement soliciting applications in a well-
defined scientific area to accomplish specific
81 All Available at: http://grants.nih.gov/grants/guide/index.html
#5 – Can foreign applicants
submit modular budgets?
• Receiving detailed budgets from foreign
applications allows NIH staff to assist applicant
community with applicable regulatory and policy
requirements for grant funding expenditure.
• This policy does not affect domestic (U.S.)
institutions with subawards to foreign (non-U.S.)
82 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-096.html
#6 – Are fellowship candidates
required to register in eRA Commons?
• Yes, applicant organizations should register any
individual fellows submitting applications to NIH
• PI Role in the Commons does not provide special
status – only a record in the system that provides
administrative authority to see pertinent application
documents (e.g. summary statements, scores,
submission status, etc.)
• Individual Fellows registered by any organization
other than the sponsoring organization should not
have more than one eRA Commons account.
83 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-003.html
#7- Are consortium F&A costs included
as part of an applicant‟s direct costs?
No. Applicants are to exclude the facilities and
administrative (F&A) costs requested by consortium
participants when determining if the budget exceeds a
direct cost limit.
• This policy applies to:
– $250K direct cost calculation for modular budgets
– $500K direct cost calculation for NIH data sharing
policy and requirement to contact IC staff for
unsolicited applications requesting over $500K
• This policy does not apply to:
– Small Business Innovation Research (SBIR) grants
– Small Business Technology Transfer (STTR) grants
84 More at: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html
#8 – Does NIH accept late
• Late applications
– Generally are not accepted, except in rare instances
• Unaccepted late applications will be returned without review
– Permission is not granted in advance
– Must be accompanied by a cover letter with compelling reasons
for the delay (including timing and nature of the cause of the
– Regular Standing Submission dates – Late applications must be
received within two weeks of standing submission date
– Expedited Standing Submission dates – Late applications must be
received within one week of standing submission date.
• NIH expects grant applications to be submitted on time
• NIH will not consider accepting late applications for the
Special Receipt Dates for RFAs and PARs
85 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-086.html
#9 – Am I allowed to reduce my
effort on a K award?
• Yes, policy allows recipient to meet required 75%
commitment of total professional effort as long as:
– The individual has a full-time appointment with the applicant
– The minimum percentage of the candidate‟s commitment required
for the proposed Career award experience is covered by that
• Grantees may reduce level of effort on most career awards
in last two years of support and replace with an NIH
research grant or subproject.
– 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.
86 More at: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html
#10 – How do I calculate person-
months in a 9-month academic year?
• Person months are the metric expressing
amount of effort faculty and other
senior/key personnel devote to a project
• How are person-months calculated?
– Multiply the percentage of effort by the number
of months of the appointment. For example:
• 10% of a 9 month academic year appointment
equals .9 person months (9 x .1 = .9 person
• 10% of a 12 month calendar appointment equals
1.2 months (12 x .10 = 1.2 person months)
87 More at: http://grants.nih.gov/grants/policy/person_months_faqs.htm
#11- What are the requirements
for recombinant DNA research?
• Institutional Biosafety Committees must review and
certify proposed recombinant DNA research.
• Serious adverse events in human gene transfer
research must be reported promptly!
– Usually within 15 days, but
– Within 7 days if life threatening or fatal.
– Annual reporting is also required.
• Full text of the guidelines are available:
– Site also includes available training opportunities.
88 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-067.html
#12 – Where do I send progress
reports? Closeout documents?
• Submit Continuation Progress Reports and
Closeout Documents (including Final Progress
Reports) electronically through eRA Commons or;
• Mail to the appropriate grants specialist or the
Central NIH unit at:
Division of Extramural Activities Support
OER National Institutes of Health
6705 Rockledge Drive, Room 2207, MSC 7987
Bethesda, MD 20892-7987 (for regular or US Postal
Service Express mail)
Bethesda, MD 20817 (for other courier/express mail
#13 - Where do I send Fellowship
• Termination notices for NRSA Fellowships
– Submit on Form PHS 416-7
– Send to Grants Management Specialist listed on
#14 – Does NIH have a cap on
• There is no cap on consultant fees and the NIH
salary cap does not apply.
• Grantees must have written policies for paying
– Are consistently applied regardless of fund source.
– Include conditions for paying consultant fees.
• Consultants must be properly classified.
– Defined as individuals who provide professional services
or advice for a fee, but normally are not employees of the
organization. Includes firms that provide advice or
#15 - Am I considered a
• “New” investigators cannot have successfully
competed as a PD/PI for most research grants.
– Does not include R03, R15, R21, R55, R66 grants
– Does not include K01, K08, K22, K23, K30, or K99/R00
• PD/PI‟s who did not initially compete for a major
research grant but were later designated as PD/PI
are still considered “new”.
• All PD/PIs must meet the new investigator definition
to receive special consideration on multi/PI grants.
#16 – How different does a “new
application” have to be?
• Expected to be substantially different in content and
• More significant differences than normally
encountered in resubmission applications.
– Rewording the Title and Specific Aims not sufficient
– Incorporating minor changes in response to reviewer
comments not sufficient
• Research Plan changes should produce a
significant change in direction and approach. All
research plan sections should have substantial
changes, particularly the Specific Aims and
Research Design and Methods sections.
#17 – As PI, what happens if I
change institutions mid-grant?
• Prior, written approval is required for transferring
legal and administrative authority for a grant to a
– Transfer approval is not automatic and requires
approval from both NIH and the original grantee
– Contact your GMO before moving to initiate the transfer
• Grants to individuals may not be transferred but
individual fellowships may transfer to a new