# Presentation: 719088

## Everything You’ve Always Wanted to Know about Research Grant Supplements

- National Advisory Council on Drug Abuse
- May 22, 2003
- Richard  A. Millstein, J.D.
- Deputy Director, NIDA
- NIH, DHHS

## Supplements...

- Occasions arise when investigators believe that their approved budgets are not sufficient. NIH has a process that allows consideration for existing budgets to receive additional funds, a “supplement”.
- There are two types of supplements
- Competitive Supplements
- Administrative Supplements

**Notes:**
Occasions arise when investigators believe that their approved budgets are not sufficient to accomplish the aims of the grant, due to costs unforeseen at the time of the application’s award. 

NIH has a process that allows consideration for existing budgets to receive additional funds, a supplement.

There are two types of supplements.

## Competitive Supplements

- “A request for an increase in support in a current budget period for expansion of the project’s approved scope of research protocol” (NIH Grants Policy Statement)
- Applicant initiates and submits on PHS 398 for peer review
- Expands beyond scope of “parent grant” but work is closely tied to it.

**Notes:**
Key Concepts:
        Competitive—the request is made on the PHS 398, submitted to CSR, and undergoes peer review just as any competing application does.  In Council Book, these are coded as a type “3”  and as an “S”.  For example the 2nd supplement to a grant would be 3 R01 DA 19999-04S2.
        Expansion beyond approved scope—when a project is moving beyond its approved scope of work or significantly changing the research protocol, but the work is still closely tied to the “parent” grant, competitive supplements should be used.  This allows for peer review of the idea and approach.  

Points for consideration:

Sometimes it’s not clear if an application should be new R01 or a competitive supplement.  In general, it should be a competitive supplement if the planned expansion depends on samples, facilities, or on-going activities supported in the “parent” project.  

It’s not always clear if something is moving beyond the approved scope or research protocol.  In general, research ideas and approaches should be examined by outside experts in the peer review process, so competitive supplements should be used when the idea or procedures are different enough from those already reviewed that the independent review would be useful.  “When in doubt, have it peer reviewed” is a good motto, ensuring that new ideas are assessed by peers. 

## Changes in Scope

- Change in specific aims
- Change from the approved use of animals or human subjects
- Shift of research emphasis from one disease area to another
- Transfer of substantive programmatic work to a third party
- 				[examples from NIH Grants Policy Statement]

**Notes:**
A “Change in scope”  would normally call for a competitive supplement.

The NIH Grants Policy Statement gives examples of changes in scope.  These examples are either of a change in science (e.g. change in specific aims) or events that suggest the science may have changed (e.g., transfer of portions of the research to a third party).

Actions likely to be considered a change in scope include, but are not limited to the examples given on the slide. 

NIH has provided some flexibility in interpreting what constitutes a change in scope.  That sometimes makes it difficult to decide if a supplement should be administrative or competitive.   

## Administrative Supplements

- “A request for additional funding for a current budget period to meet increased costs that are within the scope of the approved application but that were unforeseen...” (NIH Grants Policy Statement)
- Applicant initiates and submits for internal review

**Notes:**
Because an administrative supplement is based on a change in financial need rather than a change in scientific work or plans, it is initiated with grants management and peer review is not needed (there’s no science to review).  The request may be presented as a letter or on a PHS 398 and is sent directly to the Grants Management Branch of NIDA.

## Examples of unforeseen costs

- Salary increases
- Loss of equipment originally available from other sources (a facility closes, earthquake damage)
- Correcting errors in recommendations or awards
- Orderly termination
- Bridge Funding

**Notes:**
“Classic examples” of uses of administrative supplements– no peer review needed.  Are subject to staff review.

Correct the base salary, perhaps incident to change of institution
Unanticipated replacement of equipment
Errors in recommendations or awards
Orderly termination, when it appears a project is not going to be renewed, and funds are needed to finish up the research or reporting.  
Another use of funds is for  ‘bridge funding,” used when an ongoing project did not do well in a competing continuation application but staff believe it will do better when revised and will secure continuing support, so funds are needed to “bridge” the period between the end of the first grant and the beginning of the competitive renewal.

Grants management reviews the costs, refers to program for their input on the scientific aspects and funding, and then the supplement request is examined from a policy and budget perspective by relevant offices.  You’ll see this on the electronic form I’ll show later in this talk.  

## Administrative Supplements for Special Purposes

- NIH allows use of Administrative Supplements to achieve special purposes
- NIDA uses Administrative Supplements for these NIH-wide purposes, as well as for on-going programs and one-time applications.

**Notes:**
NIH has administrative supplement programs that do not require peer review.  Rather, staff have  authority to approve some activities.  These programs are geared toward achieving special purposes.  Similarly, NIDA uses administrative supplements for some special purposes.

## NIH-wide Administrative Supplement Programs

- Underrepresented Minorities
- Individuals with Disabilities
- Re-entry into Biomedical and Behavioral Research Careers
-    These provide supplies, salary, and travel to allow research directly related to on-going research of parent grant.

**Notes:**
NIDA participates in these NIH-wide programs
1       Research Supplements for Underrepresented Minorities
 “to increase the number of underrepresented minority scientists participating in biomedical research and the health related sciences”
 a.   NIDA  Minority research investigator supplements:
                    N Approximately 50/year
                    $ Approximately $2M/year

2    Research Supplements for Individuals with Disabilities
 “to extend opportunities to persons with qualifying disabilities who are capable of entering or resuming research careers.”

  3     Supplements to Promote Re-entry into Biomedical and Behavioral Research Careers
 “to support individuals with high potential to reenter an active research career after taking time off to care for children or attend to other family responsibilities”

## NIDA Administrative Supplements

- AIDS Supplements
- Methamphetamine
- Animal Models
- Health Disparities
- International Collaborations
- South Africa Initiative
- World Trade Center Disaster

**Notes:**
Shows how NIDA has used supplements to address gaps in portfolio and address emerging issues.
b.     AIDS supplements
        Were used for a few years, not FY 2003
        N Approximately 10-25/year
        $ Approximately $1.5M - $3M/year
        Includes about 25% co-funded with other institutes

c.     Methamphetamine MAMPH supplements
        1999 special need: N=2; $165,000

d.     Animal models supplements
        1999 only: N=23; $968,000; 20% co-funded

e.     As with c) and d), above, year ’00-’02 one-year only 
       supplements supported:  Data on them later
        Health disparities
        International
        South Africa
World Trade Center Disaster

## NIDA Dollars: “Special Supplement Programs”  

## NIDA Dollars for “Regular” Administrative Supplements 

**Notes:**
The average award decreased from $98 K in FY 2000 to $88 k in FY 20001 to $72 k in FY 2002.

## NIDA Dollars for Supplements FY 2000-2002

## Council’s Role

- Consider competitive supplements along with competing grant applications
- Advise and approve administrative supplements
- Delegated authority for some administrative supplements to NIDA staff

**Notes:**
Council’s role
Consideration of competitive supplements along with competing grant applications.  The competitive supplements are in the “Electronic COUNCIL BOOK.”
Administrative Supplements are presented in a separate folder as “action” or “information only” items.

## Council’s Delegations: Subject to budget thresholds, staff may approve--

- Increases of salary & fringe benefits
- Replacement of lost or broken equipment
- Correction of errors or oversights in applications, study section recommendations, or awards
- Orderly termination & bridge funding
- Some modifications in scope to take advantage of opportunities

**Notes:**
Through the Council delegation of authority as given in the “Council Operating Procedures” that you approve yearly (last time at the last Council meeting in Feb 2003), staff may approve the listed actions as ADMINISTRATIVE SUPPLEMENTS without taking them to Council for approval, but Council does get copies of these actions for your information (per delegation of authority).
Council, of course, retains authority for review and approval of all competitive supplements.

## Council Delegations: Council Reserved Its Approval for---

- Any supplement for 25% or more of the direct costs for the year to which the supplement is attached
- Any supplement of $100,000 or more in direct costs for any year

**Notes:**
Council did not delegate approval of administrative supplements that meet these budget thresholds.

## Electronic Tracking

- Updating Supplement:  DESPR/PRB DA R01 12345-01

- % of  parent grant:   ___

**Notes:**
NIDA has developed methods to help us better track and manage supplements.
Applicants still submit paper requests for administrative supplements, but the approval process occurs on-line, with opportunity for staff to comment [box for comments not shown.]
Requests must be reviewed (and approved) by Grants Management Office, Program, OEA, Budget, and the Deputy Director.

## Take Home Messages

- Supplements serve a range of purposes
- Administrative and competitive supplements are distinct
- NIDA is implementing more systematic tracking, analysis, and oversight of the supplement award process
- Relevance to budget scenarios in the post-NIH doubled budget years.

**Notes:**
Supplements serve a range of purposes
Administrative and competitive supplements are distinct in their purposes and in the way they are processed
NIDA, through the electronic tracking form, is implementing more oversight of the supplement award process.
The use of supplements is likely to change given the different budget climate of the post-doubling years.
e.g., 2 supplement limit

QUESTIONS? COMMENTS?