ACCEPTANCE FOR REVIEW OF UNSOLICITED APPLICATIONS THAT REQUEST MORE THAN
$500,000 DIRECT COSTS

Release Date:  March 20, 1998 (See revision dated October 16, 2001)

P.T. 

National Institutes of Health

Effective Date:  June 1, 1998

The National Institutes of Health (NIH) is updating the policy about the
acceptance of applications requesting direct costs of $500,000 or more for any
one year.  Previously this policy applied only to new unsolicited
applications.  Now the policy is being extended to ALL unsolicited
applications  - new (Type 1), competing continuation (type 2), competing
supplement and any amended/revised version of the preceding grant application
types requesting $500,000 or more in direct costs for any year.

Background

The NIH supports research projects with large budgets, but needs to consider
the possibility of such awards as early as possible in the budget and program
planning process. Unanticipated requests for unusually high amounts of direct
costs, despite the merit of the application and the justification of the
budget, are difficult to manage by NIH staff.  It is in the best interest of
all parties for anyone planning an application that requests unusually high
direct costs to contact the appropriate NIH program staff as early as possible
to ensure that an IC would be willing and able to accept the application.

This notice clarifies and revises the policy published in the NIH Guide, Vol.
25, Number 14, May 3, 1996.

NEW POLICY.  An applicant planning to submit an investigator-initiated new
(type 1), competing continuation (type 2), competing supplement or any
amended/revised version of the preceding grant application types requesting
$500,000 or more in direct costs for any year (see Applicability below) is
advised that he or she must contact Institute or Center program staff before
submitting the application, i.e., as plans for the study are being developed. 
Furthermore, the applicant must obtain agreement from Institute/Center staff
that the Institute or Center will accept the application for consideration for
award.  Finally, the applicant must identify, in the cover letter that is sent
with the application, the staff member and Institute or Center who agreed to
accept assignment of the application. This new policy requires an applicant to
obtain agreement for acceptance of both any such application and any
subsequent amendment.

Any application subject to this policy that does not contain the required
information in the cover letter sent with the application will be returned to
the applicant without review.  Applicants who are uncertain regarding which
Institute or Center to contact should call the DIVISION OF RECEIPT AND
REFERRAL, Center for Scientific Review (see INQUIRIES).

APPLICABILITY.  This policy applies to ALL investigator-initiated new (type
1), competing continuation (type 2), competing supplement and any
amended/revised version of the preceding grant application types requesting
$500,000 or more in direct costs for any year for any mechanism (e.g., R01,
P01, R18, T32).  This policy applies also to any group of unsolicited
applications (e.g., clinical trial networks, epidemiologic studies) that
requests $500,000 or more direct costs for any one year, even if none of the
individual applications request that much.

This policy does not apply to an application submitted in response to RFAs or
in response to other announcements with specific budgetary limits.  However,
such an application must be responsive to any budgetary limits specified or it
will be returned to the applicant without review.

PROCEDURES.  An applicant planning to submit a grant application to which this
policy applies is required to contact, in writing or by telephone, Institute
or Center program staff when the application development process begins.  If
the Institute or Center is willing to accept assignment of the application for
consideration of funding, the staff will notify the Center for Scientific
Review before the application is submitted.

The applicant Principal Investigator must identify, in the cover letter sent
with the application, the program staff member and Institute or Center that
has agreed to accept assignment of the application.

An application received without indication of prior staff concurrence and
identification of that contact will be returned to the applicant without
review.

EFFECTIVE DATE.  This policy becomes effective on June 1, 1998.

Applicants are encouraged, however, to contact Institute or Center staff at
any time about the preparation of applications to which this policy will
apply.

INQUIRIES

For additional information about the policy, the program staff at any IC may
be contacted.  Applicants who are uncertain about which IC may have the
greatest interest in the research for which support may be sought, should
contact:

Division of Receipt and Referral
Center for Scientific Review
National Institutes of Health
Telephone:  (301) 435-0715
FAX:  (301) 480-1987

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