U.S Code last checked for updates: Apr 26, 2024
All TitlesTitle 21Chapter 9Subchapter III
§ 335b.
Civil penalties
(a)
In general
Any person that the Secretary finds—
(1)
knowingly made or caused to be made, to any officer, employee, or agent of the Department of Health and Human Services, a false statement or misrepresentation of a material fact in connection with an abbreviated drug application,
(2)
bribed or attempted to bribe or paid or attempted to pay an illegal gratuity to any officer, employee, or agent of the Department of Health and Human Services in connection with an abbreviated drug application,
(3)
destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of, any material document or other material evidence which was the property of or in the possession of the Department of Health and Human Services for the purpose of interfering with that Department’s discharge of its responsibilities in connection with an abbreviated drug application,
(4)
knowingly failed to disclose, to an officer or employee of the Department of Health and Human Services, a material fact which such person had an obligation to disclose relating to any drug subject to an abbreviated drug application,
(5)
knowingly obstructed an investigation of the Department of Health and Human Services into any drug subject to an abbreviated drug application,
(6)
is a person that has an approved or pending drug product application and has knowingly—
(A)
employed or retained as a consultant or contractor, or
(B)
otherwise used in any capacity the services of,
a person who was debarred under section 335a of this title, or
(7)
is an individual debarred under section 335a of this title and, during the period of debarment, provided services in any capacity to a person that had an approved or pending drug product application,
shall be liable to the United States for a civil penalty for each such violation in an amount not to exceed $250,000 in the case of an individual and $1,000,000 in the case of any other person.
(b)
Procedure
(1)
In general
(A)
Action by the Secretary
(B)
Action by the Attorney General
(2)
Amount
(3)
Limitation on actions
No action may be initiated under this section—
(A)
with respect to any act described in subsection (a) that occurred before May 13, 1992, or
(B)
more than 6 years after the date when facts material to the act are known or reasonably should have been known by the Secretary but in no event more than 10 years after the date the act took place.
(c)
Judicial review
(d)
Recovery of penalties
(e)
Informants
The Secretary may award to any individual (other than an officer or employee of the Federal Government or a person who materially participated in any conduct described in subsection (a)) who provides information leading to the imposition of a civil penalty under this section an amount not to exceed—
(1)
$250,000, or
(2)
one-half of the penalty so imposed and collected,
whichever is less. The decision of the Secretary on such award shall not be reviewable.
(June 25, 1938, ch. 675, § 307, as added Pub. L. 102–282, § 3, May 13, 1992, 106 Stat. 159; amended Pub. L. 103–80, § 3(g), Aug. 13, 1993, 107 Stat. 776.)
cite as: 21 USC 335b
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