NIH GUIDE, Volume 23, Number 15, April 15, 1994

P.T. 34


  Grants Administration/Policy+ 

  Clinical Trial 


  Disease Prevention+ 

National Institute of Allergy and Infectious Diseases

The National Institute of Allergy and Infectious Diseases (NIAID)

announces that any new or competing continuation

investigator-initiated clinical trial, prevention, education, or

control intervention, or epidemiological study in which direct costs

exceed $500,000 in any year will usually be awarded as a cooperative

agreement (U01).

The $500,000 direct costs limit applies when either (1) a study is to

be conducted at one institution or (2) a study proposing

multi-institutional collaborative arrangements is submitted as either

subcontracts to a single application or as separate applications.

For single applications, the dollar limit excludes indirect costs of

any subcontracts that are reported as a direct cost on the

application budget page summary.  Separate U01 awards usually will be

made for individual applications submitted concurrently by

institutions proposing a study involving a coordinated research


This policy is effective immediately with publication of this notice

and covers all current pending unfunded applications as well as all

future submissions.

The cooperative agreement is an assistance instrument similar in most

ways to a grant.  It differs in that, in addition to the standard

stewardship role, an Institute extramural program director is

expected to have a continuing substantive role in one or more

scientific aspects of the study, in an assisting, not directing,

relationship.  The type and degree of such involvement should be

appropriate to the specific cooperative agreement.  The awardee will

have lead responsibilities in all aspects of study, including any

modification of study design, conduct of study, quality control, and

analysis of results.  The Institute program director may have

assistance roles in one or more of those areas and will have a shared

lead responsibility in facilitating interim data and safety


In order to facilitate the above interactions, it will be necessary

for awardees to plan for periodic (at least annual) meetings with

NIAID staff in the Bethesda, MD area.  Accordingly, applicants must

request, and will be allowed, sufficient funds within the submitted

budgets to accommodate expenses for participants at these meetings,

as well as for expenses incurred in the conduct and monitoring of the


All awards made as cooperative agreements under the above

circumstances will be subject to the applicable terms of award.

Specific terms, conditions, and arbitration procedures pertaining to

the scope and nature of the interaction between the NIAID and its

awardees will be incorporated in the Notices of Award.  It is

anticipated that these terms and conditions will enhance the

relationship between the National Institute of Allergy and Infectious

Diseases and the principal investigator(s) and will facilitate the

successful conduct and completion of the study.  Therefore,

applications falling under these guidelines, but not accepting the

stated conditions, will not be considered for funding.


Potential applicants for research with these characteristics are

strongly encouraged to contact the NIAID prior to making detailed

plans or submitting their application(s).  Questions regarding this

notice and requests for a generic sample of terms and conditions of

award may be directed to:

Director, Division of Extramural Activities

National Institute of Allergy and Infectious Diseases

Solar Building, Room 3C20

Bethesda, MD  20892

Telephone:  (301) 496-7291

FAX:  (301) 402-0369

Potential applicants will be referred for further consultation to the

appropriate NIAID Program and Grants Administration staff.


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