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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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10-1 - COMMUNICATIONS - DISTRICT AND CENTER RESPONSIBILITIES

10-1 - COMMUNICATIONS - DISTRICT AND CENTER RESPONSIBILITIES
      10-1-1 - Regulatory Actions that Require Center Concurrence
      10-1-2 - Regulatory Actions prepared by a Center for District Issuance and/or Follow-up
      10-1-3 - Debarment - Notification Responsibilities of FDA Employees

  10-1 - COMMUNICATIONS - DISTRICT AND CENTER RESPONSIBILITIES

  10-1-1 - Regulatory Actions that Require Center Concurrence

When a decision is made by the District that initiation of a regulatory action is appropriate, the District should notify the appropriate Center compliance unit regarding its intent to submit a recommendation.   District Compliance staff should also remember to enter the "In Review" profile status as "pending" on the Maintain Profiles screen in the Field Accomplishment and Compliance Tracking System (FACTS) for each profile class covered when the recommendation is a result of a Current Good Manufacturing Practice (CGMP) or Quality System (QS) inspection of a domestic drug, biologics, or medical device facility.  Compliance staff should also notate the Remarks field to explain the action being recommended.  When the action recommendation is forwarded to a Center for review, the Remarks field should be updated to reflect that and include the date forwarded.  With regard to foreign inspections, Center Compliance staff are responsible for the review and evaluation, and should enter the In Review "pending" status and notate the corresponding Remarks field as appropriate.  (See "Firm Profile Updates in FACTS" in Chapter 4 for more information.)

The Center will notify the District as soon as a case (compliance) officer has been assigned.This early communication will create opportunities to discuss the case, including the overall strategy, as well as the history, violations, rationale, charging scheme, regulatory and policy considerations, local knowledge, and national/program issues.

If, after its initial review of a District's recommendation, the Center compliance unit is inclined not to concur with the District's recommendation, the Center will promptly notify and provide the District with an oral explanation for its preliminary decision not to concur with the recommendation. If the District does not agree with the basis for the potential disapproval, it should provide the Center with additional justification for proceeding with the recommended action within three business days.The additional justification should be limited to information currently available to the District, not a commitment to gather additional information to support the recommendation. The Center will consider this additional justification before making a final disposition on the District's recommendation, apprise the District of its decision, and prepare the final memo. The Center's final disposition on the recommendation (approved or disapproved) will normally not be delayed if it is determined that an inspection will be necessary to collect additional supporting evidence. The involved compliance officer and the DCB should participate in discussions with the Center that occur during the process described in this paragraph. If the official action proposed was not the subject of a formal recommendation from the District (e.g. BIMO, foreign inspection), the same communication principles should apply between involved Center and District staff.

  10-1-2 - Regulatory Actions prepared by a Center for District Issuance and/or Follow-up

When a decision is made by a Center that District issuance, involvement and/or follow-up is an appropriate course of action, the Center should notify the appropriate District compliance unit(s) regarding its intent to prepare a regulatory action, and provide the District(s) with an opportunity to collaborate on the compliance strategy and the substance of the action.

10-1-3 - Debarment - Notification Responsibilities of FDA Employees

  1. Background
    1. Purpose and Authority for Debarment - Debarment is a remedial measure taken under section 306 of the Act to prohibit a person (e.g., an individual, corporation, partnership, or association) from participating in FDA-regulated activities, as described below:
      1. A person other than an individual may be prohibited from submitting, or assisting in the submission of, any abbreviated drug application. Sections 306(a)(1) and 306(b)(1)(A).
      2. An individual may be prohibited from providing services in any capacity to the sponsor of an approved or pending drug product application.  Sections 306(a)(2) and 306(b)(1)(B).
      3. A person may be prohibited from importing an article of food, or offering an article of food for import, into the United States.  Section 306(b)(1)(C).
      4. A person may be prohibited from being accredited to inspect eligible device manufacturers and from carrying out activities under agreements with foreign countries to facilitate commerce in devices.  Section 306(m)(1).  

        Debarment may be based on a criminal conviction or on conduct, as identified in section 306 of the Act.  See “Persons Subject to Debarment” below.
    2. “Drug Product” - For purposes of section 306, the term “drug product” means a drug
      subject to regulation under section 505 (new drugs), section 512 (new animal drugs), or section 802 (exports of certain unapproved products) of the Act, or under section 351 (regulation of biological products) of the Public Health Service Act.  Section 201(dd).
    3. Other Possible Actions - Civil Penalties

      Under section 307(a)(6) of the Act, any person with an approved or pending drug product application who knowingly engages the services of a debarred person is liable for civil penalties. 

      Under 307(a)(7), debarred individuals are subject to civil penalties for providing services to a person with an approved or pending drug product application.
  2.   Notification Responsibilities
    1. Authority - Staff Manual Guide (SMG) “7712 - Debarment Proceedings” provides general procedures for FDA staff to follow for debarment actions and defines the responsibilities of FDA employees.  ORA’s Office of Enforcement (OE) has responsibility for initiating and pursuing debarment actions.  All FDA employees have a responsibility to notify OE of any persons that may be subject to debarment and to forward relevant materials to OE within specified timeframes, as detailed below. 
    2. Required Notification - In accordance with SMG 7712, all FDA employees have the following responsibilities:
      1. Ensuring that ORA’s Office of Enforcement (OE) is notified when the employee has notice (from an oral or written communication) that a person may be subject to debarment.
      2. Ensuring that OE is provided with copies of all relevant materials (e.g., any written notice or petition for debarment and information supporting debarment) in the employee’s possession.
      3. Send the notification and materials to the attention of the Debarment Specialist, Division of Compliance Policy/OE via electronic transmission, interoffice or regular mail, or FAX. Include your name, office, and phone number. The Division of Compliance Policy (DCP) is located at 12420 Parklawn Drive, Rockville, Maryland 20857. Telephone 301-796-5280; FAX 301-827-3670. Contact the Debarment Specialist or DCP if you have any questions about notification or debarment, or if you need further information.
    3. Timeframes for Notification - If the person who may be subject to debarment:
      1. has an approved or pending drug application;
      2. is an employee of such a person;
      3. is a clinical investigator;
      4. is currently engaged in importing food or offering it for import; or
      5. has been convicted of a felony under section 301(gg) of the Act, FDA employees will notify OE as soon as is practicable.
      Otherwise, employees will notify OE within ninety (90) days of receiving the oral or written notice.
    4. Requirements Applicable to OCI - The Office of Criminal Investigations (OCI) is responsible for providing quarterly reports to the Director, Division of Compliance Policy (OE) that set forth all convictions that have occurred within the preceding three (3) months that may trigger debarment.
  3. Persons Subject to Debarment

    The triggering event for debarment is ordinarily a felony or misdemeanor conviction under Federal law or a felony conviction under State law.  However, certain conduct may subject a food importer, and, for drugs and biologics, a high managerial agent (and other individuals) to debarment.  The types of convictions and conduct that may subject persons to debarment are detailed in section 306 of the Act and summarized below, by product type.
    1. Foods:  A person (an individual, corporation, partnership, or association) is subject to debarment if the person has been convicted of a felony for conduct relating to the importation into the U.S. of any food, or has engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious adverse health consequences or death to humans or animals.  Section 306(b)(3).
    2. Drugs – Corporations, Partnerships, and Associations:  A person other than an individual is subject to debarment if that person has been:
      1. Convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any abbreviated drug application. Section 306(a)(1).
      2. Convicted for conduct that relates to the development or approval, including the process for development or approval, of any abbreviated drug application, and is a misdemeanor under Federal law or a felony under State law.  Section 306(b)(2)(A)(i).
      3. Convicted of a conspiracy to commit, or aiding or abetting, a criminal offense described in i. or ii. above.  Section 306(b)(2)(A)(ii). 
    3. Drugs/Biologics – Individuals:  An individual is subject to debarment if s/he has been:
      1. Convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product, or otherwise relating to the regulation of any drug product under the Act.  Section 306(a)(2).
      2. Convicted of a misdemeanor under Federal law or a felony under State law for conduct relating to the development or approval, including the process for development or approval, of any drug product, or otherwise relating to the regulation of drug products under the Act, or has been convicted of a conspiracy to commit, or aiding or abetting, a criminal offense described in this paragraph or the preceding paragraph.  Section 306(b)(2)(B)(i).
      3. Convicted of a felony under Federal law or a felony under State law which involves bribery, payment of illegal gratuities, fraud, perjury, false statement, racketeering, blackmail, extortion, falsification or destruction of records, or interference with, obstruction of an investigation into, or prosecution of, any criminal offense, or a conspiracy to commit, or aiding or abetting, such felony.  Section 306(b)(2)(B)(ii).
    4. Drugs/Biologics – Debarment based on Conduct:  An individual is also subject to debarment: 
      1. If s/he materially participated in acts that were the basis for a conviction for an offense subject to debarment.  Section 306(b)(2)(B)(iii).
      2. If s/he is a high managerial agent who: 
        • worked for, or worked as a consultant for, the same person as another individual during the period in which such other individual took actions for which a felony conviction was obtained and which resulted in the debarment of such individual;
        • had actual knowledge of the actions described above of such other individual, or took action to avoid such actual knowledge, or failed to take action for the purpose of avoiding such actual knowledge;
        • knew that the actions were violative of law; and
        • did not report such actions, or did not cause such actions to be reported, to an officer, employee, or agent of the Department or to an appropriate law enforcement officer, or failed to take other appropriate 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 actions.  Sections 201(bb) and (cc), and 306(b)(2)(B)(iv).
    5. Devices:  A person (an individual, corporation, partnership, or association) accredited to inspect eligible device manufacturers is subject to debarment if the person has been convicted of a felony for one or more prohibited acts under section 301(gg) of the Act.  Section 306(m).  

      Section 301(gg) prohibits the knowing failure to notify the Secretary of a condition the accredited person discovered during an inspection that could cause or contribute to an unreasonable risk to the public health as required by section 704(g)(7)(E), or an accredited person’s knowing inclusion of false information in an inspection report prepared under section 704(g)(7)(A), or the knowing failure to include material facts in such a report.