21 CFR 1404.830 - Under what conditions do I get an additional opportunity to challenge the facts on which a proposed debarment is based?

Code of Federal Regulations - Title 21: Food and Drugs (December 2005)


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TITLE 21 - FOOD AND DRUGS

CHAPTER III - OFFICE OF NATIONAL DRUG CONTROL POLICY

PART 1404 - GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)

subpart h - DEBARMENT

1404.830 - Under what conditions do I get an additional opportunity to challenge the facts on which a proposed debarment is based?

  (a) You as a respondent will not have an additional opportunity to challenge the facts if the debarring official determines that (1) Your debarment is based upon a conviction or civil judgment; (2) Your presentation in opposition contains only general denials to information contained in the Notice of Proposed Debarment; or (3) The issues raised in your presentation in opposition to the proposed debarment are not factual in nature, or are not material to the debarring official's decision whether to debar.

  (b) You will have an additional opportunity to challenge the facts if the debarring official determines that (1) The conditions in paragraph (a) of this section do not exist; and (2) Your presentation in opposition raises a genuine dispute over facts material to the proposed debarment.

  (c) If you have an opportunity to challenge disputed material facts under this section, the debarring official or designee must conduct additional proceedings to resolve those facts.

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