National Institutes of Health Basics

1
National Institutes of Health Basics

• An Overview of the NIH Grants Process Unique
  Vocabulary

2
NIH As A Grant-Making Organization

• NIH is an agency within the Public Health Service
  (PHS), which is under the umbrella of the
  Department of Health Human Services (HHS)
• NIHs mission is to improve human health by
  increasing scientific knowledge related to
  disease health.
• NIH is made up of 27 Institutes and Centers
  (ICs), each with its own mission and functions,
  separate appropriations and statutory
  authorities.
• They are loosely organized under the Office of
  the NIH Director, with broad authority to set
  their own policies and make their own grant
  funding decisions.

3
NIHs Extramural Research Program

• The NIH conducts its own Intramural Research
  Program utilizing staff scientists on its
  Bethesda campus.
• The NIH Extramural Research Grants Program funds
  research nationally at universities and research
  centers through grants, cooperative agreements
  and contracts.

4
NIH Office of Extramural Research

• The OER website is the best place to start when
  looking for information about NIH grants
  http//grants1.nih.gov/grants/oer.htm

• You can find there
• NIH Guide for Grants
• Contracts containing
• Notices, PAs/RFAs/RFPs
• Application Forms
• Supplemental Guidelines
• Policies
• Peer Review Information

5
Understanding the NIH Grants Process

• NIH receives over 28,000 competing grant
  applications per year.
• The Center for Scientific Review (CSR) receives
  almost 10,000 applications per grant cycle.
• NIH funded about 17,000 applications in FY01.
• The success rate for competing R01 applications
  hovers around 30.

CSRs mailroom on deadline day.
6
So What Happens To That Grant Application After
it Leaves RSP?The NIH Grant Peer Review Process
Revealed

• Applications received at NIH are sorted by
  Referral Officers at CSR to determine which
  Integrated Review Group (IRG) would be most
  appropriate for assessment of scientific merit.
  IRGs are clusters of study sections that review
  similar science.
• Once the IRG is identified, the application is
  then assigned to one of the constituent study
  sections within the IRG.
• In addition to the IRG assignment, Referral
  Officers also identify which Institute(s)/Center(s
  ) (I/C) of the NIH would be most suitable to fund
  the application, should it be considered
  sufficiently meritorious.
• Once the I/C is identified, a unique application
  number is assigned to each application. The
  Referral Office seriously considers written
  requests from applicants for both study section
  and Institute assignments (just include a cover
  letter with the application).

A brief description of the peer review process
can be found on the NIH website at
http//www.csr.nih.gov/review/peerrev.htm
7
The NIH Peer Review Process

• After an application is assigned to a Study
  Section, the Scientific Review Administrator
  (SRA) assigns it to 2 or 3 members to read.
• Those applications believed to rank in the lower
  half of the group of applications are
  streamlined or triagedi.e., they are returned
  to the applicant without review. The applicant
  may revise the application and re-submit it for a
  later deadline.
• The Study Section reviews and ranks applications,
  assigning a priority score to each proposal.
• Priority scores and percentile rankings are
  transmitted to the funding institutes, where
  Program Officials make funding recommendations to
  the Institutes National Advisory Council. The
  Advisory Council conducts a second level of
  review and makes final funding decisions.

It generally takes at least 10 months for a grant
to be funded after it is submitted to NIH. A
proposal submitted on February 1 will not be
funded before December.
8
NIH Contracts, Cooperative Agreements and
GrantsWhats the Difference?

• NIH Grants are considered financial assistance to
  support activities in the public interest. NIH
  assumes that the grantee (UW-Madison) would have
  conducted the activity/research regardless of
  whether or not NIH funded it. Generally, the
  grantee controls all scientific aspects of the
  project under grant funding.
• NIH utilizes the Cooperative Agreement when it
  wishes to retain control over the scientific and
  programmatic aspects of the project. While
  cooperative agreements are considered a financial
  assistance mechanism, the rules governing the use
  of funds and conduct of the activity are more
  restrictive than those governing standard
  research grants. (They normally are not under FDP
  or Expanded Authorities.)
• The Contract mechanism is used when NIH wishes to
  purchase a product or service. Contracts are not
  financial assistance. The contract is a
  procurement mechanism by which the government
  purchases goods or services that it needs.
• The remainder of this presentation is concerned
  primarily with grants. However, please be aware
  that NIH contract opportunities require complex
  applications, and the PI should give RSP as much
  lead time as possible. NIH issues a Request for
  Proposals (RFP) inviting proposals for contract
  opportunities. The RFP number will look
  something like N02CP31013-38. Contract proposals
  must follow the instructions in the RFP and
  generally are NOT submitted on the standard NIH
  grant application forms. Contract proposals
  require both a technical plan and a business
  plan. The business plan includes Representations
  and Certifications which must be signed by RSP.

9
R01s and K08s and T32s, Oh My! So What Do
All Those Letters Mean?

• NIH uses a variety of funding mechanisms,
  including grants, cooperative agreements
  contracts.
• Grants Cooperative Agreements are classified by
  Activity Codes that indicate the kind of
  activity that will be conducted under the
  project
• The R-series indicates Research Project Grants,
  e.g., R01, R03, R21.
• The P-series indicates Program Project Grants,
  e.g., P01, P30, P50.
• The T-series indicates institutional NRSA
  training grants.
• The K-series indicates career development awards.
• The F-series indicates individual NRSA
  fellowships.

The IMPAC Manual contains complete explanations
of all activity codes and other arcane NIH
classification codes. It may be found at
http//grants1.nih.gov/grants/funding/funding.htm
10
A Rose is A Rose By Any Other NameBut What Does
That NIH Grant Number Mean?

• The NIH application number or grant number
  conveys a wealth of information about the grant.
• The first digit indicates the Type of Application
  i.e., new(1), non-competing continuation (5),
  competing renewal (2), supplemental (3), or
  transfer(7).
• The second set of three characters indicates the
  Activity Code, i.e, R01 is a Research Project
  Grant.
• The two-letter code tells you the funding
  institute, i.e., AR is the National Institute of
  Arthritis Musculoskeletal Skin Diseases
  (NIAMS).
• The six-digit code is the NIH serial number.
• The two digits following the dash indicate the
  year of funding.
• Suffixes after the year may indicate that the
  application is amended/revised (A) or is a
  supplement (S) to an existing grant.

2 R01 CA 597631-05A1 The above grant is a
competing renewal of a Research Project Grant
funded by the NCI. This is the 5th year of
funding, and the application is the first
amendment/revision of a previously unfunded
competing renewal application.
11
NIH Grant Vocabulary

• Competitive Segment The initial project period
  recommended for support (up to 5 years) or each
  extension of a project period resulting from a
  competing continuation award that establishes a
  new competitive segment for the project.
• Budget Period The intervals of time, usually 12
  months each, into which a project period is
  divided for budgetary and funding purposes.
• Project Period The total time for which NIH
  approves support of a project. The total project
  period is comprised of the initial competitive
  segment, any subsequent competitive segment
  resulting from competing continuation awards, and
  non-competing extensions.
• New Application A grant application for a new
  project that has not previously been submitted to
  NIH for funding consideration.
• Revised Application An application which was
  previously not funded by NIH and which the PI has
  revised to address the concerns of peer
  reviewers. NIH will only accept up to 2
  revisions of the same application.
• Competing Continuation/Renewal An application
  that requests funding of an additional several
  years for a project that was previously funded
  for a period of several years by NIH. The
  renewal application must compete with all other
  new, revised and competing continuation
  applications, i.e., it receives no special
  consideration for funding.
• Non-competing Continuation An application that
  must be submitted each year within the
  competitive segment in order to receive the next
  budget year of funding. This application
  includes the PIs annual progress report on the
  science of the project. This application does
  not compete with others for funding, since the
  funding was already committed by NIH at the
  beginning of the competitive segment.

12
So Many Application Kits, So Little Time Which
NIH Application Should the PI Use?

• PHS-398
• New, Revised and Competing Renewals of Research
  Project Grants (R-series), Career Development
  Awards (K-series) and Institutional NRSA
  Training Grants (T-series).
• PHS-2590
• Non-competing continuations of all the above
  grant series.
• PHS-416-1
• New and Revised Individual NRSA Fellowships
  (F-series)
• PHS-416-9
• Non-competing continuations of F-series grants.

13
PHS-398 SUBMISSION REQUIREMENTS

• Cover Letter (optional)
• Original, single sided application w/ PI and RSP
  signatures
• 5 exact single sided copies (made after signature
  of original), DO NOT STAPLE
• 5 collated sets of appendix materials

14
PHS-398 APPLICATION KIT REMINDERS

• Text Size Helvetica or Arial 11 Point /15
  Characters Per Inch / 6 Lines Per Vertical Inch
• Watch page limitations on Research Plan
• IRB, IACUC Biosafety approval letters should be
  attached, if available

15
Revised PHS 398 Forms (Rev. 05/01)

• Four (4) page Biographical Sketch
• Biosketch the same for modular and non-modular
  submission
• NO Other Support, until requested
• NO Personnel Report, until requested
• Checklist includes space to calculate FA for
  each project year
• Provisions for SBIR/STTR applications

16
Biosketch Reminder for the PHS-398

• Biosketch format is identical for modular and
  non-modular submissions
• Four (4) page limit
• NOTE Positions, Education and Honors and
  Publications sections each may not exceed two
  of the four page limit
• Include section on Research Support (Ongoing
  Completed in the Last 3 Years)

17
NIH Budget Preparation for the Traditional
Format DIRECT COSTS

• Personnel (Salary Fringe)
• Consultant Costs
• Supplies
• Equipment
• gt 5,000 equipment
• lt 5,000 supplies
• Travel
• Patient Care Costs
• Other Expenses

• Equipment is defined at UW-Madison as an article
  of tangible nonexpendable personal property that
  has a useful life of more than 1 year and an
  acquisition cost of 5,000 or more per unit.

18
Budget TerminologyFRINGE BENEFITS

• Retirement
• FICA
• Health Dental
• Tuition Reimbursement
• Post Retirement Benefits
• Other

19
NIH Budget PreparationFringe Benefit Rates
(FY06-07)

• Regular Faculty and Academic Staff  35.00
• Regular Classified 50.00
• Research Associates and Grad Interns 24.00
• Research Assistants, Project Assistants, Teaching
  Assistants, Pre-Doc Fellows and/or
  Trainees  27.00
• Post-Doc Fellows and/or Trainees 12.50
• Limited Term Employes (LTE's) 20.00
• Ad Hoc Program Specialists, Undergraduate
  Assistants and Undergraduate Interns 6.00
• Student Hourly Employee 2.00
• The rates for Research, Project, and Teaching 
  Assistants, and Pre and Post-doctoral Fellows
  and/or Trainees represent the Universitys
  contribution to health insurance only.  All other
  rates include the Universitys contribution to
  retirement, health and life insurance, social
  security, unemployment and worker's compensation
  insurance, and income continuation insurance as
  appropriate.

20
Budget TerminologyFacilities Administration
Costs

• Definition
• Costs that are incurred by a grantee organization
• for common or joint objectives which cannot be
• identified specifically with a particular project
  or
• program.
• FA Rates may be found on RSPs website at
• http//www.rsp.wisc.edu/rates.html

21
Variations on a ThemeNIH Modular Grants

• NIH modular grant process applies to
• Research Project Grant Unsolicited New,
  Revised,Competing Continuation, Competing
  Supplements (R01, R03, R15, R21, R41, R43)
• For applications up to 250,000 direct cost
  annually or IF SPECIFIED in program announcement
  or request for applications

22
What is MODULAR about it?

• Costs requested in Modules of 25,000
• e.g., 125,000, 225,000
• Level funding for life of competitive period
• A typical modular grant application will request
  the same number of modules in each year.
• NOTE This is not a requirement, but any
  variation in modules must be justified.
• No detailed categorical budget information
• Narrative information for Personnel, and (if
  applicable) consortium/contractual

23
Why the MODULAR GRANT?

• Simplify/Improve NIH granting process
• Simplify/Improve NIH oversight process
• Saves Administrative Effort
• -Eliminate pre-award cost analysis
• -Focus on Science, not cost detail
• Eliminates post-award categorical budget
  oversight
• Oversight based on total cost
• Emphasize Program over administration

24
Advantages to the PI

• Competes on basis of Science, not budget detail
• Minimizes post-award categorical cost management
• Must manage project, but not tied to budget
• Automatic carry-forward
• Requirement for prior approval from NIH for
  Significant Rebudgeting is eliminated

25
Disadvantages to the PI

• Extra step preparing proposal budget
• Detailed budget still needed by most Division
• Requires careful post-award management of funds
  (responsibility falls to institution to monitor)
• Carry-over (greater than 25) rules still apply

26
Preparing the Modular NIH Grant Proposal

• Integrated into PHS 398 (Rev. 04/2006) SF424
  RR
• No submission of detailed budget
• Provide only narrative NIH Modular Grant budget
  justification
• Bottom line direct cost totals for each year
  grand total
• Budget justification listing key personnel by
  position, role, and level of effort (no salaries)
• Itemize subcontracts to nearest 1,000

27
More Variations on a ThemeJust-in-Time
Instructions for the PHS-398

• Just-in-Time concept applies to the R- and
  K-series. These instructions are now
  incorporated into the PHS-398 instructions.
• Just-in-Time instructions are still occasionally
  seen in a PA or RFA. Be aware that the special
  instructions found in the relevant PA or RFA take
  precedence over the standard instructions in the
  PHS-398 kit.
• Just-in-Time applies to IRB and IACUC approvals
  and Other Support.

28
Using the NIH PHS-2590 Application The
Complete, Traditional Format

• Some grants, such as Program Project Grants
  (P-series) and Institutional Training Grants
  (T-series) must use the complete, traditional
  instructions for the PHS-2590.
• For these grants, PIs must complete all the
  relevant forms for their non-competing
  continuation applications, according to the
  PHS-2590 instructions.

29
The PHS-2590 the Streamlined Non-competing
Award Process (SNAP)

• Most NIH awards under Expanded Authorities and/or
  Federal Demonstration Partnership (FDP) are under
  SNAP. These may include R01, R03, R13, R15, R18,
  R21, R24, R25, R29, R37, R42, R44, and K awards.
• The Streamlined Non-competing Award Process
  (SNAP) instructions do not require submission of
  a detailed budget.
• Check the PIs NIH Notice of Grant Award (NGA) to
  be certain the grant is under SNAP.

30
Its A SNAP!

• PIs may submit SNAP applications electronically
  through the NIH Commons.
• There are only three parts to a paper SNAP
  application 1) Face Page 2) Progress Report
  Summary and 3) Personnel Report.
• A Checklist Page is required only if there has
  been a change in the performance site that
  affects the FA rate for the grant and/or if
  program income is anticipated. (It is not
  necessary to complete a Checklist Page just
  because the UW-Madison F A rate changes. The
  exact instructions are found on page 2 of the PHS
  2590 kit.)

31
SNAP Instructions for the PHS-2590

• Face Page No Dollar Amounts Required On the
  face page, NIH asks that items 8a and 8b remain
  blank. This is because the NIH already has
  committed to a specific funding level that will
  be granted in the continuation years of a grant.
  For this reason, as well, NIH does not want a
  detailed budget with SNAP applications.
• Progress Report The Three Questions NIH
  requires a Progress Report Summary (Form Page 5)
  with SNAP applications. In addition to the
  scientific progress report, three specific
  questions must be answered
• Has there been a change in the other support of
  key personnel since the last reporting period?
• Will there be, in the next budget period, a
  significant change in the level of effort for key
  personnel from what was approved for this
  project? (gt25 reduction)
• Is it anticipated that an estimated unobligated
  balance (including prior year carryover) will be
  greater than 25 percent of the current year's
  total budget?
• If the answer to any of these questions is "yes,"
  an explanation must be given.
• If there has been a change in the other support
  of any key personnel, updated Other Support pages
  must be submitted. When a previously active grant
  has terminated and/or a previously pending grant
  is now active, then a report is necessary.
• Change in level of effort for key personnel is
  described as a reduction by 25 percent in time
  devoted to a project, regardless of whether or
  not the individual receives salary on the grant.
  (Note that according to the NIH Grants Policy
  Manual, change in level of effort only applies to
  persons named in the NGA, almost always only the
  PI.)
• Significant Rebudgeting Not Applicable Effective
  with the revised NIH Policy Statement issued
  March 1, 2001, the question regarding significant
  rebudgeting is no longer applicable and does not
  need to be answered.
• Personnel Report Form The final page required
  for a SNAP application is the Personnel Report
  Form. All Key Personnel for the current budget
  period who participated in the project during the
  current budget period should be listed.

32
The PHS-416-1 and PHS-416-9

• The PHS-416-1 is used for new and revised
  individual National Research Service Award (NRSA)
  fellowships (F31, F32, F33.)
• The PHS-416-9 is used for non-competing
  continuation applications (progress reports) for
  currently funded fellowships.
• In addition to the instructions in the PHS-416,
  applicants should use the relevant supplemental
  instructions found at http//grants1.nih.gov/trai
  ning/nrsa.htmfellowships
• Certain specialized NRSA programs have
  supplemental guidelines, as do certain Institutes
  within NIH.
• For example, applicants for the standard
  Postdoctoral Individual NRSA Fellowship should
  refer to the general postdoctoral program
  announcement at http//grants1.nih.gov/grants/gui
  de/pa-files/PA-06-373.html

33
Mysteries of A-21 Cost Accounting Standards

• Cost Accounting Standards (CAS) Policy
• EFFECTIVE SEPTEMBER 1, 1994
• FOLLOWING COSTS UNALLOWABLE AS Direct Costs,
  except in justified extraordinary circumstances
• Clerical/Administrative Salaries
• Postage
• Office Supplies
• Local Telephone Service/Equipment
• Dues/Memberships
• General Purpose Equipment
• UW-Madison relies upon the College/School Deans
  offices to review budgets for CAS Exceptions.

34
COMPLIANCE ISSUES

• INSTITUTIONAL REVIEW BOARD proof of approval
  required by NIH in a Just-in-Time manner prior
  to issuance of award.
• INSTITUTIONAL ANIMAL CARE USE COMMITTEE proof
  of approval required by NIH in a Just-in-Time
  manner prior to issuance of award.
• OFFICE OF BIOLOGICAL SAFETY
• Authorized Organizational Official signature
  (RSP) on application certifies that the project
  will not be conducted without this approval in
  place.

35
NIH Grants Policy Statement The Ultimate Answer
Source

• When in doubt, refer to the NIH Grants Policy
  Statement, revised 12/03.
• It contains answers to questions about prior
  approval requirements, expanded authorities,
  NIH-specific FDP terms and conditions,
  allowability of costs, and rules for flowdown of
  terms to subcontractors/consortium participants.
• It may be found athttp//grants1.nih.gov/grants/
  policy/nihgps_2003/