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[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2008]
[CITE: 21CFR1404]





TITLE 21--FOOD AND DRUGS
CHAPTER III--OFFICE OF NATIONAL DRUG CONTROL POLICY
 
PART 1404GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)
 

Sec. 1404.25 How is this part organized?

(a) This part is subdivided into ten subparts. Each subpart contains information related to a broad topic or specific audience with special responsibilities, as shown in the following table:

In subpart . . .You will find provisions related to . . .
Ageneral information about this rule.
Bthe types of Office of National Drug Control Policy transactions that are covered by the Governmentwide nonprocurement suspension and debarment system.
Cthe responsibilities of persons who participate in covered transactions.
Dthe responsibilities of Office of National Drug Control Policy officials who are authorized to enter into covered transactions.
Ethe responsibilities of Federal agencies for theExcluded Parties List System(Disseminated by the General Services Administration).
Fthe general principles governing suspension, debarment, voluntary exclusion and settlement.
Gsuspension actions.
Hdebarment actions.
Idefinitions of terms used in this part.
J[Reserved]

(b) The following table shows which subparts may be of special interest to you, depending on who you are:

If you are . . .See subpart(s) . . .
(1) a participant or principal in a nonprocurement transactionA, B, C, and I.
(2) a respondent in a suspension actionA, B, F, G and I.
(3) a respondent in a debarment actionA, B, F, H and I.
(4) a suspending officialA, B, D, E, F, G and I.
(5) a debarring officialA, B, D, E, F, H and I.
(6) a (n) Office of National Drug Control Policy official authorized to enter into a covered transactionA, B, D, E and I.
(7) ReservedJ.
Sec. 1404.50 How is this part written?

(a) This part uses a "plain language" format to make it easier for the general public and business community to use. The section headings and text, often in the form of questions and answers, must be read together.

(b) Pronouns used within this part, such as "I" and "you," change from subpart to subpart depending on the audience being addressed. The pronoun "we" always is the Office of National Drug Control Policy.

(c) The "Covered Transactions" diagram in the appendix to this part shows the levels or "tiers" at which the Office of National Drug Control Policy enforces an exclusion under this part.

Sec. 1404.75 Do terms in this part have special meanings?

This part uses terms throughout the text that have special meaning. Those terms are defined in Subpart I of this part. For example, three important terms are--

(a)Exclusion or excluded, which refers only to discretionary actions taken by a suspending or debarring official under this part or the Federal Acquisition Regulation (48 CFR part 9, subpart 9.4);

(b)Disqualification or disqualified, which refers to prohibitions under specific statutes, executive orders (other than Executive Order 12549 and Executive Order 12689), or other authorities. Disqualifications frequently are not subject to the discretion of an agency official, may have a different scope than exclusions, or have special conditions that apply to the disqualification; and

(c)Ineligibility or ineligible, which generally refers to a person who is either excluded or disqualified.

Subpart F--General Principles Relating to Suspension and Debarment Actions

Sec. 1404.600 How do suspension and debarment actions start?

When we receive information from any source concerning a cause for suspension or debarment, we will promptly report and investigate it. We refer the question of whether to suspend or debar you to our suspending or debarring official for consideration, if appropriate.

Sec. 1404.605 How does suspension differ from debarment?
Sec. 1404.610 What procedures does the Office of National Drug Control Policy use in suspension and debarment actions?

Suspension differs from debarment in that--

A suspending official . . .A debarring official . . .
(a) Imposes suspension as a temporary status of ineligibility for procurement and nonprocurement transactions, pending completion of an investigation or legal proceedingsImposes debarment for a specified period as a final determination that a person is not presently responsible.
(b) Must--(1) Haveadequate evidencethat there may be a cause for debarment of a person; and(2) Conclude thatimmediate actionis necessary to protect the Federal interestMust conclude, based on apreponderance of the evidence,that the person has engaged in conduct that warrants debarment.
(c) Usually imposes the suspensionfirst,and then promptly notifies the suspended person, giving the person an opportunity to contest the suspension and have it liftedImposes debarmentaftergiving the respondent notice of the action and an opportunity to contest the proposed debarment.

In deciding whether to suspend or debar you, we handle the actions as informally as practicable, consistent with principles of fundamental fairness.

(a) For suspension actions, we use the procedures in this subpart and subpart G of this part.

(b) For debarment actions, we use the procedures in this subpart and subpart H of this part.

Sec. 1404.615 How does the Office of National Drug Control Policy notify a person of a suspension or debarment action?

(a) The suspending or debarring official sends a written notice to the last known street address, facsimile number, or e-mail address of--

(1) You or your identified counsel; or

(2) Your agent for service of process, or any of your partners, officers, directors, owners, or joint venturers.

(b) The notice is effective if sent to any of these persons.

Sec. 1404.620 Do Federal agencies coordinate suspension and debarment actions?

Yes, when more than one Federal agency has an interest in a suspension or debarment, the agencies may consider designating one agency as the lead agency for making the decision. Agencies are encouraged to establish methods and procedures for coordinating their suspension and debarment actions.

Sec. 1404.625 What is the scope of a suspension or debarment?

If you are suspended or debarred, the suspension or debarment is effective as follows:

(a) Your suspension or debarment constitutes suspension or debarment of all of your divisions and other organizational elements from all covered transactions, unless the suspension or debarment decision is limited--

(1) By its terms to one or more specifically identified individuals, divisions, or other organizational elements; or

(2) To specific types of transactions.

(b) Any affiliate of a participant may be included in a suspension or debarment action if the suspending or debarring official--

(1) Officially names the affiliate in the notice; and

(2) Gives the affiliate an opportunity to contest the action.

Sec. 1404.630 May the Office of National Drug Control Policy impute conduct of one person to another?

For purposes of actions taken under this rule, we may impute conduct as follows:

(a)Conduct imputed from an individual to an organization. We may impute the fraudulent, criminal, or other improper conduct of any officer, director, shareholder, partner, employee, or other individual associated with an organization, to that organization when the improper conduct occurred in connection with the individual's performance of duties for or on behalf of that organization, or with the organization's knowledge, approval or acquiescence. The organization's acceptance of the benefits derived from the conduct is evidence of knowledge, approval or acquiescence.

(b)Conduct imputed from an organization to an individual, or between individuals. We may impute the fraudulent, criminal, or other improper conduct of any organization to an individual, or from one individual to another individual, if the individual to whom the improper conduct is imputed either participated in, had knowledge of, or reason to know of the improper conduct.

(c)Conduct imputed from one organization to another organization. We may impute the fraudulent, criminal, or other improper conduct of one organization to another organization when the improper conduct occurred in connection with a partnership, joint venture, joint application, association or similar arrangement, or when the organization to whom the improper conduct is imputed has the power to direct, manage, control or influence the activities of the organization responsible for the improper conduct. Acceptance of the benefits derived from the conduct is evidence of knowledge, approval or acquiescence.

Sec. 1404.635 May the Office of National Drug Control Policy settle a debarment or suspension action?

Yes, we may settle a debarment or suspension action at any time if it is in the best interest of the Federal Government.

Sec. 1404.640 May a settlement include a voluntary exclusion?

Yes, if we enter into a settlement with you in which you agree to be excluded, it is called a voluntary exclusion and has governmentwide effect.

Sec. 1404.645 Do other Federal agencies know if the Office of National Drug Control Policy agrees to a voluntary exclusion?

(a) Yes, we enter information regarding a voluntary exclusion into theEPLS.

(b) Also, any agency or person may contact us to find out the details of a voluntary exclusion.



Appendix to Part 1404--Covered Transactions

View or download PDF

Authority: E.O. 12549 3 CFR 1986 Comp., p. 189; E.O. 12689 3 CFR 1989 Comp., p. 235; sec. 2455, Pub. L. 103-355, 108 Stat. 3327 (31 U.S.C. 6101 note); 21 U.S.C. 1701.
Source: 68 FR 66544, 66580, 66581, Nov. 26, 2003, unless otherwise noted.

Database Updated April 1, 2008

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