21 C.F.R. PART 1404--GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)
TITLE 21-Food and Drugs
CHAPTER III--OFFICE OF NATIONAL DRUG CONTROL POLICY
PART 1404--GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)
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| How is this part organized?
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| How is this part written?
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| Do terms in this part have special meanings?
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Subpart A--GENERAL
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| Does this part apply to me?
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| What is the purpose of the nonprocurement debarment and suspension system?
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| How does an exclusion restrict a person's involvement in covered transactions?
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| May we grant an exception to let an excluded person participate in a covered transaction?
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| Does an exclusion under the nonprocurement system affect a person's eligibility for Federal procurement contracts?
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| Does exclusion under the Federal procurement system affect a person's eligibility to participate in nonprocurement transactions?
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| May the Office of National Drug Control Policy exclude a person who is not currently participating in a nonprocurement transaction?
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| How do I know if a person is excluded?
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| Does this part address persons who are disqualified, as well as those who are excluded from nonprocurement transactions?
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Subpart B--COVERED TRANSACTIONS
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| What is a covered transaction?
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| Why is it important if a particular transaction is a covered transaction?
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| Which nonprocurement transactions are covered transactions?
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| Which nonprocurement transactions are not covered transactions?
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| Are any procurement contracts included as covered transactions?
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| How do I know if a transaction in which I may participate is a covered transaction?
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Subpart C--RESPONSIBILITIES OF PARTICIPANTS REGARDING TRANSACTIONS
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| What must I do before I enter into a covered transaction with another person at the next lower tier?
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| May I enter into a covered transaction with an excluded or disqualified person?
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| What must I do if a Federal agency excludes a person with whom I am already doing business in a covered transaction?
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| May I use the services of an excluded person as a principal under a covered transaction?
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| Must I verify that principals of my covered transactions are eligible to participate?
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| What happens if I do business with an excluded person in a covered transaction?
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| What requirements must I pass down to persons at lower tiers with whom I intend to do business?
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| What information must I provide before entering into a covered transaction with the Office of National Drug Control Policy?
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| If I disclose unfavorable information required under 1404.335, will I be prevented from participating in the transaction?
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| What happens if I fail to disclose information required under 1404.335?
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| What must I do if I learn of information required under 1404.335 after entering into a covered transaction with the Office of National Drug Control Policy?
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| What information must I provide to a higher tier participant before entering into a covered transaction with that participant?
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| What happens if I fail to disclose the information required under 1404.355?
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| What must I do if I learn of information required under 1404.355 after entering into a covered transaction with a higher tier participant?
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Subpart D--RESPONSIBILITIES OF OFFICE OF NATIONAL DRUG CONTROL POLICY OFFICIALS REGARDING TRANSACTIONS
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| May I enter into a transaction with an excluded or disqualified person?
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| May I enter into a covered transaction with a participant if a principal of the transaction is excluded?
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| May I approve a participant's use of the services of an excluded person?
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| What must I do if a Federal agency excludes the participant or a principal after I enter into a covered transaction?
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| May I approve a transaction with an excluded or disqualified person at a lower tier?
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| When do I check to see if a person is excluded or disqualified?
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| How do I check to see if a person is excluded or disqualified?
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| What must I require of a primary tier participant?
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| What method do I use to communicate those requirements to participants?
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| What action may I take if a primary tier participant knowingly does business with an excluded or disqualified person?
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| What action may I take if a primary tier participant fails to disclose the information required under 1404.335?
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| What may I do if a lower tier participant fails to disclose the information required under 1404.355 to the next higher tier?
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Subpart E--EXCLUDED PARTIES LIST SYSTEM
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| What is the purpose of the Excluded Parties List System (EPLS)?
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| What specific information is in the EPLS?
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| Who places the information into the EPLS?
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| Whom do I ask if I have questions about a person in the EPLS?
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| Where can I find the EPLS?
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Subpart F--GENERAL PRINCIPLES RELATING TO SUSPENSION AND DEBARMENT ACTIONS
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| How do suspension and debarment actions start?
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| How does suspension differ from debarment?
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| What procedures does the Office of National Drug Control Policy use in suspension and debarment actions?
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| How does the Office of National Drug Control Policy notify a person of a suspension or debarment action?
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| Do Federal agencies coordinate suspension and debarment actions?
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| What is the scope of a suspension or debarment?
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| May the Office of National Drug Control Policy impute conduct of one person to another?
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| May the Office of National Drug Control Policy settle a debarment or suspension action?
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| May a settlement include a voluntary exclusion?
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| Do other Federal agencies know if the Office of National Drug Control Policy agrees to a voluntary exclusion?
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Subpart G--SUSPENSION
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| When may the suspending official issue a suspension?
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| What does the suspending official consider in issuing a suspension?
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| When does a suspension take effect?
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| What notice does the suspending official give me if I am suspended?
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| How may I contest a suspension?
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| How much time do I have to contest a suspension?
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| What information must I provide to the suspending official if I contest a suspension?
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| Under what conditions do I get an additional opportunity to challenge the facts on which the suspension is based?
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| Are suspension proceedings formal?
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| How is fact-finding conducted?
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| What does the suspending official consider in deciding whether to continue or terminate my suspension?
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| When will I know whether the suspension is continued or terminated?
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| How long may my suspension last?
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Subpart H--DEBARMENT
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| What are the causes for debarment?
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| What notice does the debarring official give me if I am proposed for debarment?
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| When does a debarment take effect?
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| How may I contest a proposed debarment?
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| How much time do I have to contest a proposed debarment?
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| What information must I provide to the debarring official if I contest a proposed debarment?
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| Under what conditions do I get an additional opportunity to challenge the facts on which a proposed debarment is based?
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| Are debarment proceedings formal?
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| How is fact-finding conducted?
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| What does the debarring official consider in deciding whether to debar me?
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| What is the standard of proof in a debarment action?
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| Who has the burden of proof in a debarment action?
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| What factors may influence the debarring official's decision?
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| How long may my debarment last?
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| When do I know if the debarring official debars me?
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| May I ask the debarring official to reconsider a decision to debar me?
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| What factors may influence the debarring official during reconsideration?
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| May the debarring official extend a debarment?
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Subpart I--DEFINITIONS
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| Excluded Parties List System
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| Ineligible or ineligibility.
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| Nonprocurement transaction.
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| Preponderance of the evidence.
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| Voluntary exclusion or voluntarily excluded.
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Subpart J--[RESERVED]
