21 U.S.C. § 335a — Debarment, temporary denial of approval,

Page 69 TITLE 21—FOOD AND DRUGS § 335a § 335a. Debarment, temporary denial of approval, and suspension (a) Mandatory debarment; certain drug applica- tions (1) Corporations, partnerships, and associa- tions If the Secretary finds that a person other than an individual has been convicted, after May 13, 1992, of a felony under Federal law for conduct relating to the development or ap- proval, including the process for development or approval, of any abbreviated drug applica- tion, the Secretary shall debar such person from submitting, or assisting in the submis- sion of, any such application. (2) Individuals If the Secretary finds that an individual has been convicted of a felony under Federal law for conduct— (A) relating to the development or ap- proval, including the process for develop- ment or approval, of any drug product, or (B) otherwise relating to the regulation of any drug product under this chapter, the Secretary shall debar such individual from providing services in any capacity to a person that has an approved or pending drug product application. (b) Permissive debarment; certain drug applica- tions; food imports (1) In general The Secretary, on the Secretary’s own ini- tiative or in response to a petition, may, in ac- cordance with paragraph (2) or (3), debar— (A) a person other than an individual from submitting or assisting in the submission of any abbreviated drug application; (B) an individual from providing services in any capacity to a person that has an ap- proved or pending drug product application; (C) a person from importing an article of food or offering such an article for import into the United States; or (D) a person from importing or offering for import into the United States a drug. (2) Persons subject to permissive debarment; certain drug applications The following persons are subject to debar- ment under subparagraph (A) or (B) of para- graph (1): (A) Corporations, partnerships, and associa- tions Any person other than an individual that the Secretary finds has been convicted— (i) for conduct that— (I) relates to the development or ap- proval, including the process for the de- velopment or approval, of any abbre- viated drug application; and (II) is a felony under Federal law (if the person was convicted before May 13, 1992), a misdemeanor under Federal law, or a felony under State law, or (ii) of a conspiracy to commit, or aiding or abetting, a criminal offense described in clause (i) or a felony described in sub- section (a)(1), if the Secretary finds that the type of con- duct which served as the basis for such con- viction undermines the process for the regu- lation of drugs. (B) Individuals (i) Any individual whom the Secretary finds has been convicted of— (I) a misdemeanor under Federal law or a felony under State law for conduct relat- ing to the development or approval, in- cluding the process for development or ap- proval, of any drug product or otherwise relating to the regulation of drug products under this chapter, or (II) a conspiracy to commit, or aiding or abetting, such criminal offense or a felony described in subsection (a)(2), if the Secretary finds that the type of con- duct which served as the basis for such con- viction undermines the process for the regu- lation of drugs. (ii) Any individual whom the Secretary finds has been convicted of— (I) a felony which is not described in sub- section (a)(2) or clause (i) of this subpara- graph and which involves bribery, payment of illegal gratuities, fraud, perjury, false statement, racketeering, blackmail, extor- tion, falsification or destruction of records, or interference with, obstruction of an investigation into, or prosecution of, any criminal offense, or (II) a conspiracy to commit, or aiding or abetting, such felony, if the Secretary finds, on the basis of the conviction of such individual and other in- formation, that such individual has dem- onstrated a pattern of conduct sufficient to find that there is reason to believe that such individual may violate requirements under this chapter relating to drug products. (iii) Any individual whom the Secretary finds materially participated in acts that were the basis for a conviction for an offense described in subsection (a) or in clause (i) or (ii) for which a conviction was obtained, if the Secretary finds, on the basis of such par- ticipation and other information, that such individual has demonstrated a pattern of conduct sufficient to find that there is rea- son to believe that such individual may vio- late requirements under this chapter relat- ing to drug products. (iv) Any high managerial agent whom the Secretary finds— (I) worked for, or worked as a consultant for, the same person as another individual during the period in which such other indi- vidual took actions for which a felony con- viction was obtained and which resulted in the debarment under subsection (a)(2), or clause (i), of such other individual, (II) had actual knowledge of the actions described in subclause (I) of such other in- dividual, or took action to avoid such ac- tual knowledge, or failed to take action for the purpose of avoiding such actual knowledge, (III) knew that the actions described in subclause (I) were violative of law, and Page 70 TITLE 21—FOOD AND DRUGS § 335a (IV) did not report such actions, or did not cause such actions to be reported, to an officer, employee, or agent of the De- partment or to an appropriate law enforce- ment officer, or failed to take other appro- priate action that would have ensured that the process for the regulation of drugs was not undermined, within a reasonable time after such agent first knew of such ac- tions, if the Secretary finds that the type of con- duct which served as the basis for such other individual’s conviction undermines the proc- ess for the regulation of drugs. (3) Persons subject to permissive debarment; food or drug importation A person is subject to debarment under para- graph (1)(C) if— (A) the person has been convicted of a fel- ony for conduct relating to the importation into the United States of any food; (B) the person has engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious ad- verse health consequences or death to hu- mans or animals; (C) the person has been convicted of a fel- ony for conduct relating to the importation into the United States of any drug or con- trolled substance (as defined in section 802 of this title); (D) the person has engaged in a pattern of importing or offering for import— (i) controlled substances that are prohib- ited from importation under section 1401(m) of title 19; or (ii) adulterated or misbranded drugs that are— (I) not designated in an authorized electronic data interchange system as a product that is regulated by the Sec- retary; or (II) knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary. (4) Stay of certain orders An order of the Secretary under clause (iii) or (iv) of paragraph (2)(B) shall not take effect until 30 days after the order has been issued. (5) Definition For purposes of paragraph (3)(D), the term ‘‘pattern of importing or offering for import’’ means importing or offering for import a drug described in clause (i) or (ii) of paragraph (3)(D) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer. (c) Debarment period and considerations (1) Effect of debarment The Secretary— (A) shall not accept or review (other than in connection with an audit under this sec- tion) any abbreviated drug application sub- mitted by or with the assistance of a person debarred under subsection (a)(1) or (b)(2)(A) during the period such person is debarred, (B) shall, during the period of a debarment under subsection (a)(2) or (b)(2)(B), debar an individual from providing services in any ca- pacity to a person that has an approved or pending drug product application and shall not accept or review (other than in connec- tion with an audit under this section) an ab- breviated drug application from such indi- vidual, and (C) shall, if the Secretary makes the find- ing described in paragraph (6) or (7) of sec- tion 335b(a) of this title, assess a civil pen- alty in accordance with section 335b of this title. (2) Debarment periods (A) In general The Secretary shall debar a person under subsection (a) or (b) for the following peri- ods: (i) The period of debarment of a person (other than an individual) under sub- section (a)(1) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under sub- section (a) occurs within 10 years after such person has been debarred under sub- section (a)(1), the period of debarment shall be permanent. (ii) The debarment of an individual under subsection (a)(2) shall be permanent. (iii) The period of debarment of any per- son under paragraph (2) or (3) of subsection (b) shall not be more than 5 years. The Secretary may determine whether de- barment periods shall run concurrently or consecutively in the case of a person debarred for multiple offenses. (B) Notification Upon a conviction for an offense described in subsection (a) or (b) or upon execution of an agreement with the United States to plead guilty to such an offense, the person involved may notify the Secretary that the person acquiesces to debarment and such person’s debarment shall commence upon such notification. (3) Considerations In determining the appropriateness and the period of a debarment of a person under sub- section (b) and any period of debarment be- yond the minimum specified in subparagraph (A)(i) of paragraph (2), the Secretary shall con- sider where applicable— (A) the nature and seriousness of any of- fense involved, (B) the nature and extent of management participation in any offense involved, wheth- er corporate policies and practices encour- aged the offense, including whether inad- equate institutional controls contributed to the offense, (C) the nature and extent of voluntary steps to mitigate the impact on the public of any offense involved, including the recall or the discontinuation of the distribution of suspect drugs, full cooperation with any in- vestigations (including the extent of disclo- sure to appropriate authorities of all wrong- doing), the relinquishing of profits on drug approvals fraudulently obtained, and any Page 71 TITLE 21—FOOD AND DRUGS § 335a 1 So in original. Probably should be ‘‘section’’. other actions taken to substantially limit potential or actual adverse effects on the public health, (D) whether the extent to which changes in ownership, management, or operations have corrected the causes of any offense involved and provide reasonable assurances that the offense will not occur in the future, (E) whether the person to be debarred is able to present adequate evidence that cur- rent production of drugs subject to abbre- viated drug applications and all pending ab- breviated drug applications are free of fraud or material false statements, and (F) prior convictions under this chapter or under other Acts involving matters within the jurisdiction of the Food and Drug Ad- ministration. (d) Termination of debarment (1) Application Any person that is debarred under sub- section (a) (other than a person permanently debarred) or any person that is debarred under subsection (b) may apply to the Secretary for termination of the debarment under this sub- section. Any information submitted to the Secretary under this paragraph does not con- stitute an amendment or supplement to pend- ing or approved abbreviated drug applications. (2) Deadline The Secretary shall grant or deny any appli- cation respecting a debarment which is sub- mitted under paragraph (1) within 180 days of the date the application is submitted. (3) Action by the Secretary (A) Corporations (i) Conviction reversal If the conviction which served as the basis for the debarment of a person under subsection (a)(1) or paragraph (2)(A) or (3) of subsection (b) is reversed, the Secretary shall withdraw the order of debarment. (ii) Application Upon application submitted under para- graph (1), the Secretary shall terminate the debarment of a person if the Secretary finds that— (I) changes in ownership, management, or operations have fully corrected the causes of the offense involved and pro- vide reasonable assurances that the of- fense will not occur in the future, and (II) in applicable cases, sufficient au- dits, conducted by the Food and Drug Administration or by independent ex- perts acceptable to the Food and Drug Administration, demonstrate that pend- ing applications and the development of drugs being tested before the submission of an application are free of fraud or ma- terial false statements. In the case of persons debarred under sub- section (a)(1), such termination shall take effect no earlier than the expiration of one year from the date of the debarment. (B) Individuals (i) Conviction reversal If the conviction which served as the basis for the debarment of an individual under subsection (a)(2) or clause (i), (ii), (iii), or (iv) of subsection (b)(2)(B) or sub- section (b)(3) is reversed, the Secretary shall withdraw the order of debarment. (ii) Application Upon application submitted under para- graph (1), the Secretary shall terminate the debarment of an individual who has been debarred under subsection (b)(2)(B) or subsection (b)(3) if such termination serves the interests of justice and adequately pro- tects the integrity of the drug approval process or the food importation process, as the case may be. (4) Special termination (A) Application Any person that is debarred under sub- section (a)(1) (other than a person perma- nently debarred under subsection (c)(2)(A)(i)) or any individual who is debarred under sub- section (a)(2) may apply to the Secretary for special termination of debarment under this subsection. Any information submitted to the Secretary under this subparagraph does not constitute an amendment or supplement to pending or approved abbreviated drug ap- plications. (B) Corporations Upon an application submitted under sub- paragraph (A), the Secretary may take the action described in subparagraph (D) if the Secretary, after an informal hearing, finds that— (i) the person making the application under subparagraph (A) has demonstrated that the felony conviction which was the basis for such person’s debarment involved the commission of an offense which was not authorized, requested, commanded, performed, or recklessly tolerated by the board of directors or by a high managerial agent acting on behalf of the person within the scope of the board’s or agent’s office or employment, (ii) all individuals who were involved in the commission of the offense or who knew or should have known of the offense have been removed from employment involving the development or approval of any drug subject to sections 1 355 of this title, (iii) the person fully cooperated with all investigations and promptly disclosed all wrongdoing to the appropriate authorities, and (iv) the person acted to mitigate any im- pact on the public of any offense involved, including the recall, or the discontinu- ation of the distribution, of any drug with respect to which the Secretary requested a recall or discontinuation of distribution due to concerns about the safety or effi- cacy of the drug. (C) Individuals Upon an application submitted under sub- paragraph (A), the Secretary may take the action described in subparagraph (D) if the Page 72 TITLE 21—FOOD AND DRUGS § 335a Secretary, after an informal hearing, finds that such individual has provided substan- tial assistance in the investigations or pros- ecutions of offenses which are described in subsection (a) or (b) or which relate to any matter under the jurisdiction of the Food and Drug Administration. (D) Secretarial action The action referred to in subparagraphs (B) and (C) is— (i) in the case of a person other than an individual— (I) terminating the debarment imme- diately, or (II) limiting the period of debarment to less than one year, and (ii) in the case of an individual, limiting the period of debarment to less than per- manent but to no less than 1 year, whichever best serves the interest of justice and protects the integrity of the drug ap- proval process. (e) Publication and list of debarred persons The Secretary shall publish in the Federal Register the name of any person debarred under subsection (a) or (b), the effective date of the de- barment, and the period of the debarment. The Secretary shall also maintain and make avail- able to the public a list, updated no less often than quarterly, of such persons, of the effective dates and minimum periods of such debarments, and of the termination of debarments. (f) Temporary denial of approval (1) In general The Secretary, on the Secretary’s own ini- tiative or in response to a petition, may, in ac- cordance with paragraph (3), refuse by order, for the period prescribed by paragraph (2), to approve any abbreviated drug application sub- mitted by any person— (A) if such person is under an active Fed- eral criminal investigation in connection with an action described in subparagraph (B), (B) if the Secretary finds that such per- son— (i) has bribed or attempted to bribe, has paid or attempted to pay an illegal gra- tuity, or has induced or attempted to in- duce another person to bribe or pay an ille- gal gratuity to any officer, employee, or agent of the Department of Health and Human Services or to any other Federal, State, or local official in connection with any abbreviated drug application, or has conspired to commit, or aided or abetted, such actions, or (ii) has knowingly made or caused to be made a pattern or practice of false state- ments or misrepresentations with respect to material facts relating to any abbre- viated drug application, or the production of any drug subject to an abbreviated drug application, to any officer, employee, or agent of the Department of Health and Human Services, or has conspired to com- mit, or aided or abetted, such actions, and (C) if a significant question has been raised regarding— (i) the integrity of the approval process with respect to such abbreviated drug ap- plication, or (ii) the reliability of data in or con- cerning such person’s abbreviated drug ap- plication. Such an order may be modified or terminated at any time. (2) Applicable period (A) In general Except as provided in subparagraph (B), a denial of approval of an application of a per- son under paragraph (1) shall be in effect for a period determined by the Secretary but not to exceed 18 months beginning on the date the Secretary finds that the conditions described in subparagraphs (A), (B), and (C) of paragraph (1) exist. The Secretary shall terminate such denial— (i) if the investigation with respect to which the finding was made does not result in a criminal charge against such person, if criminal charges have been brought and the charges have been dismissed, or if a judgment of acquittal has been entered, or (ii) if the Secretary determines that such finding was in error. (B) Extension If, at the end of the period described in subparagraph (A), the Secretary determines that a person has been criminally charged for an action described in subparagraph (B) of paragraph (1), the Secretary may extend the period of denial of approval of an appli- cation for a period not to exceed 18 months. The Secretary shall terminate such exten- sion if the charges have been dismissed, if a judgment of acquittal has been entered, or if the Secretary determines that the finding described in subparagraph (A) was in error. (3) Informal hearing Within 10 days of the date an order is issued under paragraph (1), the Secretary shall pro- vide such person with an opportunity for an informal hearing, to be held within such 10 days, on the decision of the Secretary to refuse approval of an abbreviated drug applica- tion. Within 60 days of the date on which such hearing is held, the Secretary shall notify the person given such hearing whether the Sec- retary’s refusal of approval will be continued, terminated, or otherwise modified. Such noti- fication shall be final agency action. (g) Suspension authority (1) In general If— (A) the Secretary finds— (i) that a person has engaged in conduct described in subparagraph (B) of sub- section (f)(1) in connection with 2 or more drugs under abbreviated drug applications, or (ii) that a person has engaged in flagrant and repeated, material violations of good manufacturing practice or good laboratory practice in connection with the develop- ment, manufacturing, or distribution of Page 73 TITLE 21—FOOD AND DRUGS § 335a one or more drugs approved under an ab- breviated drug application during a 2-year period, and— (I) such violations may undermine the safety and efficacy of such drugs, and (II) the causes of such violations have not been corrected within a reasonable period of time following notice of such violations by the Secretary, and (B) such person is under an active inves- tigation by a Federal authority in connec- tion with a civil or criminal action involving conduct described in subparagraph (A), the Secretary shall issue an order suspending the distribution of all drugs the development or approval of which was related to such con- duct described in subparagraph (A) or sus- pending the distribution of all drugs approved under abbreviated drug applications of such person if the Secretary finds that such con- duct may have affected the development or ap- proval of a significant number of drugs which the Secretary is unable to identify. The Sec- retary shall exclude a drug from such order if the Secretary determines that such conduct was not likely to have influenced the safety or efficacy of such drug. (2) Public health waiver The Secretary shall, on the Secretary’s own initiative or in response to a petition, waive the suspension under paragraph (1) (involving an action described in paragraph (1)(A)(i)) with respect to any drug if the Secretary finds that such waiver is necessary to protect the public health because sufficient quantities of the drug would not otherwise be available. The Secretary shall act on any petition seeking ac- tion under this paragraph within 180 days of the date the petition is submitted to the Sec- retary. (h) Termination of suspension The Secretary shall withdraw an order of sus- pension of the distribution of a drug under sub- section (g) if the person with respect to whom the order was issued demonstrates in a petition to the Secretary— (1)(A) on the basis of an audit by the Food and Drug Administration or by experts accept- able to the Food and Drug Administration, or on the basis of other information, that the de- velopment, approval, manufacturing, and dis- tribution of such drug is in substantial com- pliance with the applicable requirements of this chapter, and (B) changes in ownership, management, or operations— (i) fully remedy the patterns or practices with respect to which the order was issued, and (ii) provide reasonable assurances that such actions will not occur in the future, or (2) the initial determination was in error. The Secretary shall act on a submission of a pe- tition under this subsection within 180 days of the date of its submission and the Secretary may consider the petition concurrently with the suspension proceeding. Any information sub- mitted to the Secretary under this subsection does not constitute an amendment or supple- ment to a pending or approved abbreviated drug application. (i) Procedure The Secretary may not take any action under subsection (a), (b), (c), (d)(3), (g), or (h) with re- spect to any person unless the Secretary has issued an order for such action made on the record after opportunity for an agency hearing on disputed issues of material fact. In the course of any investigation or hearing under this sub- section, the Secretary may administer oaths and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the at- tendance and testimony of witnesses and the production of evidence that relates to the mat- ter under investigation. (j) Judicial review (1) In general Except as provided in paragraph (2), any per- son that is the subject of an adverse decision under subsection (a), (b), (c), (d), (f), (g), or (h) may obtain a review of such decision by the United States Court of Appeals for the District of Columbia or for the circuit in which the person resides, by filing in such court (within 60 days following the date the person is noti- fied of the Secretary’s decision) a petition re- questing that the decision be modified or set aside. (2) Exception Any person that is the subject of an adverse decision under clause (iii) or (iv) of subsection (b)(2)(B) may obtain a review of such decision by the United States District Court for the District of Columbia or a district court of the United States for the district in which the per- son resides, by filing in such court (within 30 days following the date the person is notified of the Secretary’s decision) a complaint re- questing that the decision be modified or set aside. In such an action, the court shall deter- mine the matter de novo. (k) Certification Any application for approval of a drug product shall include— (1) a certification that the applicant did not and will not use in any capacity the services of any person debarred under subsection (a) or (b), in connection with such application, and (2) if such application is an abbreviated drug application, a list of all convictions, described in subsections (a) and (b) which occurred with- in the previous 5 years, of the applicant and affiliated persons responsible for the develop- ment or submission of such application. (l) Applicability (1) Conviction For purposes of this section, a person is con- sidered to have been convicted of a criminal offense— (A) when a judgment of conviction has been entered against the person by a Federal or State court, regardless of whether there is an appeal pending, (B) when a plea of guilty or nolo contendere by the person has been accepted by a Federal or State court, or Page 74 TITLE 21—FOOD AND DRUGS § 335a (C) when the person has entered into par- ticipation in a first offender, deferred adju- dication, or other similar arrangement or program where judgment of conviction has been withheld. (2) Effective dates Subsection (a), subparagraph (A) of sub- section (b)(2), clauses (i) and (ii) of subsection (b)(2)(B), and subsection (b)(3)(A) shall not apply to a conviction which occurred more than 5 years before the initiation of an agency action proposed to be taken under subsection (a) or (b). Clauses (iii) and (iv) of subsection (b)(2)(B), subsection (b)(3)(B), and subsections (f) and (g) shall not apply to an act or action which occurred more than 5 years before the initiation of an agency action proposed to be taken under subsection (b), (f), or (g). Clause (iv) of subsection (b)(2)(B) shall not apply to an action which occurred before June 1, 1992. Subsection (k) shall not apply to applications submitted to the Secretary before June 1, 1992. (m) Devices; mandatory debarment regarding third-party inspections and reviews (1) In general If the Secretary finds that a person has been convicted of a felony under section 331(gg) of this title, the Secretary shall debar such per- son from being accredited under section 360m(b) or 374(g)(2) of this title and from car- rying out activities under an agreement de- scribed in section 383(b) of this title. (2) Debarment period The Secretary shall debar a person under paragraph (1) for the following periods: (A) The period of debarment of a person (other than an individual) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under such paragraph occurs within 10 years after such person has been debarred under such paragraph, the period of debarment shall be permanent. (B) The debarment of an individual shall be permanent. (3) Termination of debarment; judicial review; other matters Subsections (c)(3), (d), (e), (i), (j), and (l)(1) apply with respect to a person (other than an individual) or an individual who is debarred under paragraph (1) to the same extent and in the same manner as such subsections apply with respect to a person who is debarred under subsection (a)(1), or an individual who is debarred under subsection (a)(2), respectively. (June 25, 1938, ch. 675, § 306, as added Pub. L. 102–282, § 2, May 13, 1992, 106 Stat. 150; amended Pub. L. 105–115, title I, § 125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 107–188, title III, § 304(a)–(c), June 12, 2002, 116 Stat. 665, 666; Pub. L. 107–250, title II, § 203, Oct. 26, 2002, 116 Stat. 1610; Pub. L. 115–271, title III, § 3022(b)(2), Oct. 24, 2018, 132 Stat. 3938.) Editorial Notes PRIOR PROVISIONS A prior section 306 of act June 25, 1938, was renum- bered section 309 and is classified to section 336 of this title. AMENDMENTS 2018—Subsec. (b)(1). Pub. L. 115–271, § 3022(b)(2)(A)(i), inserted ‘‘or (3)’’ after ‘‘paragraph (2)’’ in introductory provisions. Subsec. (b)(1)(D). Pub. L. 115–271, § 3022(b)(2)(A)(ii)–(v), added subpar. (D). Subsec. (b)(3). Pub. L. 115–271, § 3022(b)(2)(B)(i), in- serted ‘‘or drug’’ after ‘‘food’’ in heading. Subsec. (b)(3)(C), (D). Pub. L. 115–271, § 3022(b)(2)(B)(ii)–(iv), added subpars. (C) and (D). Subsec. (b)(5). Pub. L. 115–271, § 3022(b)(2)(C), added par. (5). 2002—Subsec. (a). Pub. L. 107–188, § 304(b)(1), sub- stituted ‘‘Mandatory debarment; certain drug applica- tions’’ for ‘‘Mandatory debarment’’ in heading. Subsec. (b). Pub. L. 107–188, § 304(b)(2)(A), substituted ‘‘Permissive debarment; certain drug applications; food imports’’ for ‘‘Permissive debarment’’ in heading. Subsec. (b)(1)(C). Pub. L. 107–188, § 304(a)(1), added sub- par. (C). Subsec. (b)(2). Pub. L. 107–188, § 304(b)(2)(B), sub- stituted ‘‘permissive debarment; certain drug applica- tions’’ for ‘‘permissive debarment’’ in heading. Pub. L. 107–188, § 304(a)(2)(A), inserted ‘‘subparagraph (A) or (B) of’’ before ‘‘paragraph (1)’’ in introductory provisions. Subsec. (b)(3), (4). Pub. L. 107–188, § 304(a)(2)(B), (C), added par. (3) and redesignated former par. (3) as (4). Subsec. (c)(2)(A)(iii). Pub. L. 107–188, § 304(b)(3), sub- stituted ‘‘paragraph (2) or (3) of subsection (b)’’ for ‘‘subsection (b)(2)’’. Subsec. (d)(3)(A)(i). Pub. L. 107–188, § 304(b)(4)(A), sub- stituted ‘‘subsection (a)(1) or paragraph (2)(A) or (3) of subsection (b)’’ for ‘‘subsection (a)(1) or (b)(2)(A)’’. Subsec. (d)(3)(A)(ii)(II). Pub. L. 107–188, § 304(b)(4)(B), inserted ‘‘in applicable cases,’’ before ‘‘sufficient au- dits’’. Subsec. (d)(3)(B)(i). Pub. L. 107–188, § 304(b)(4)(C), in- serted ‘‘or subsection (b)(3)’’ after ‘‘subsection (b)(2)(B)’’. Subsec. (d)(3)(B)(ii). Pub. L. 107–188, § 304(b)(4)(C), (D), inserted ‘‘or subsection (b)(3)’’ after ‘‘subsection (b)(2)(B)’’ and ‘‘or the food importation process, as the case may be’’ before period. Subsec. (l)(2). Pub. L. 107–188, § 304(c), in first sentence struck out ‘‘and’’ after ‘‘subsection (b)(2),’’ and inserted ‘‘, and subsection (b)(3)(A)’’ after ‘‘subsection (b)(2)(B)’’ and in second sentence inserted ‘‘, subsection (b)(3)(B),’’ after ‘‘subsection (b)(2)(B)’’. Subsec. (m). Pub. L. 107–250 added subsec. (m). 1997—Subsec. (d)(4)(B)(ii). Pub. L. 105–115 struck out ‘‘or 357’’ after ‘‘355’’. Statutory Notes and Related Subsidiaries CONSTRUCTION Pub. L. 102–282, § 7, May 13, 1992, 106 Stat. 162, provided that: ‘‘No amendment made by this Act [enacting this section and sections 335b and 335c of this title and amending sections 321, 336, 337, and 355 of this title] shall preclude any other civil, criminal, or administra- tive remedy provided under Federal or State law, in- cluding any private right of action against any person for the same action subject to any action or civil pen- alty under an amendment made by this Act.’’ CONGRESSIONAL FINDINGS Pub. L. 102–282, § 1(c), May 13, 1992, 106 Stat. 149, pro- vided that: ‘‘The Congress finds that— ‘‘(1) there is substantial evidence that significant corruption occurred in the Food and Drug Adminis- tration’s process of approving drugs under abbre- viated drug applications, ‘‘(2) there is a need to establish procedures designed to restore and to ensure the integrity of the abbre- viated drug application approval process and to pro- tect the public health, and ‘‘(3) there is a need to establish procedures to bar individuals who have been convicted of crimes per- Page 75 TITLE 21—FOOD AND DRUGS § 335b taining to the regulation of drug products from work- ing for companies that manufacture or distribute such products.’’ § 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 Depart- ment 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 of- ficer, 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, re- moval, or secretion of, any material document or other material evidence which was the property of or in the possession of the Depart- ment 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 ap- plication, (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 pend- ing drug product application and has know- ingly— (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 de- barment, 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 indi- vidual and $1,000,000 in the case of any other per- son. (b) Procedure (1) In general (A) Action by the Secretary A civil penalty under subsection (a) shall be assessed by the Secretary on a person by an order made on the record after an oppor- tunity for an agency hearing on disputed issues of material fact and the amount of the penalty. In the course of any investiga- tion or hearing under this subparagraph, the Secretary may administer oaths and affir- mations, examine witnesses, receive evi- dence, and issue subpoenas requiring the at- tendance and testimony of witnesses and the production of evidence that relates to the matter under investigation. (B) Action by the Attorney General In lieu of a proceeding under subparagraph (A), the Attorney General may, upon request of the Secretary, institute a civil action to recover a civil money penalty in the amount and for any of the acts set forth in sub- section (a). Such an action may be insti- tuted separately from or in connection with any other claim, civil or criminal, initiated by the Attorney General under this chapter. (2) Amount In determining the amount of a civil penalty under paragraph (1), the Secretary or the court shall take into account the nature, cir- cumstances, extent, and gravity of the act subject to penalty, the person’s ability to pay, the effect on the person’s ability to continue to do business, any history of prior, similar acts, and such other matters as justice may require. (3) Limitation on actions No action may be initiated under this sec- tion— (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 rea- sonably should have been known by the Sec- retary but in no event more than 10 years after the date the act took place. (c) Judicial review Any person that is the subject of an adverse decision under subsection (b)(1)(A) may obtain a review of such decision by the United States Court of Appeals for the District of Columbia or for the circuit in which the person resides, by filing in such court (within 60 days following the date the person is notified of the Secretary’s de- cision) a petition requesting that the decision be modified or set aside. (d) Recovery of penalties The Attorney General may recover any civil penalty (plus interest at the currently pre- vailing rates from the date the penalty became final) assessed under subsection (b)(1)(A) in an action brought in the name of the United States. The amount of such penalty may be deducted, when the penalty has become final, from any sums then or later owing by the United States to the person against whom the penalty has been assessed. In an action brought under this subsection, the validity, amount, and appro- priateness of the penalty shall not be subject to judicial review. (e) Informants The Secretary may award to any individual (other than an officer or employee of the Fed- eral Government or a person who materially participated in any conduct described in sub- section (a)) who provides information leading to the imposition of a civil penalty under this sec- tion an amount not to exceed—