Executive Order 12549, "Debarment and Suspension," mandated development of a Governmentwide debarment and suspension system for nonprocurement transactions with Federal agencies. Nonprocurement transactions include grants, cooperative agreements, and fellowships. DHHS regulations implementing Executive Order 12549 are provided in 45 CFR 76, "Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide Requirements for Drug-Free Workplace (Grants)." Accordingly, before a grant award can be made, the applicant organization must make the following certification (Appendix A of the DHHS regulations):
"(1) The prospective primary participant certifies to the best of its knowledge and belief, that it and its principals (including research personnel):
(a) Are not presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from covered transactions by any Federal department or agency;
(b) Have not within a three-year period preceding this proposal been convicted of or had a civil judgment rendered against them for commissions of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State or local) transaction or contract under a public transaction; violation of Federal or State antitrust statutes or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, or receiving stolen property;
(c) Are not presently indicted for or otherwise criminally or civilly charged by a governmental entity (Federal, State or local) with commission of any of the offenses enumerated in paragraph (1)(b) of this certification; and
(d) Have not within a three-year period preceding this application/proposal had one or more public transactions (Federal, State or local) terminated for cause or default.
(2) Where the prospective primary participant is unable to certify to any of the statements in this certification, such prospective participant shall attach an explanation to this proposal."
Grantees are required to obtain a similar certification from most subawardees (called "lower tier participants"). See 45 CFR 76, Appendices A and B.