National Advisory Council or Board, mandated by statute, providing the second level of review for grant applications for each Institute/Center awarding grants. The Councils/Boards are comprised of both scientific and lay representatives. Council/Board recommendations are based on scientific merit (as judged by the initial review groups) and the relevance of the proposed study to an institute's programs and priorities. With some exceptions, grants cannot be awarded without recommendations for approval by a Council/Board.
An ancillary clinical trial to a larger clinical trial may be considered an independent clinical trial if it includes an additional intervention to patients or a sub-population of patients within the larger clinical trial. An example of an ancillary study that is not a clinical trial could be research which involves analyses of stored samples collected in an ongoing clinical trial but no additional intervention to the human subjects/patients.
Application Submission System & Interface for Submission Tracking (ASSIST)
Cluster of Programs
Cognizant Agency for Audit
Cognizant Agency for Indirect Costs
Conflict of Interest
Debarment and Suspension
Departmental Grants Appeals Board
Dual Review System
Early Stage Investigator (ESI)
ECB-Council Portal and Archive
Depending on the context, in either paragraph (1) or (2) of this section:
(1)(i) The Federal financial assistance that a non-Federal entity receives directly from a Federal awarding agency or indirectly from a pass-through entity, as described in 45 CFR 75.101; or
(ii) The cost-reimbursement contract under the Federal Acquisition Regulations that a non-Federal entity receives directly from a Federal awarding agency or indirectly from a pass-through entity, as described in 45 CFR 75.101.
(2) The instrument setting forth the terms and conditions. The instrument is the grant agreement, cooperative agreement, other agreement for assistance covered in paragraph (2) of Federal financial assistance, or the cost-reimbursement contract awarded under the Federal Acquisition Regulations.
(3) Federal award does not include other contracts that a Federal agency uses to buy goods or services from a contractor or a contract to operate Federal government owned, contractor operated facilities (GOCOs).
Federal Award Identification Number
Federal Demonstration Partnership (FDP)
Federal Financial Assistance
(1) For grants and cooperative agreements, Federal financial assistance means assistance that non-Federal entities receive or administer in the form of:
(ii) Cooperative agreements;
(iii) Non-cash contributions or donations of property (including donated surplus property);
(iv) Direct appropriations;
(v) Food commodities; and
(vi) Other financial assistance (except assistance listed in paragraph (b) of this section).
(2) For Subpart F of 45 CFR 75, Federal financial assistance also includes assistance that non-Federal entities receive or administer in the form of:
(ii) Loan Guarantees;
(iii) Interest subsidies; and
(iv) Insurance.(3) Federal financial assistance does not include amounts received as reimbursement for services rendered to individuals as described in 45 CFR 75.502(h) and (i).
Federal Financial Report (FFR)
(1) All Federal awards which are assigned a single number in the CFDA.
(2) When no CFDA number is assigned, all Federal awards to non- Federal entities from the same agency made for the same purpose should be combined and considered one program.
(3) Notwithstanding paragraphs (1) and (2) of this definition, a cluster of programs.
The types of clusters of programs are:
(i) Research and development (R&D);
(ii) Student financial aid (SFA); and
(iii) "Other clusters,'' as described in the definition of Cluster of Programs.