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AIP Procedures

1-1-5 Responsibilities Of Agency Personnel And Organization

All FDA employees are responsible for working together to ensure that the AIP is consistently applied when warranted. Agency managers, including supervisors, and directors in each Division, Office, Center, District and Region may delegate authority for carrying out the responsibilities related to the AIP. Responsibilities are set out below.

  1. Each employee should:
    1. be familiar with the Agency's procedures for carrying out the AIP, and the name and telephone number of the AIP contact person (Attachment A);
    2. be aware of the ways in which a person might subvert the integrity of the approval process by committing a wrongful act, e.g., bribing an Agency employee, submitting false data, etc.;
    3. promptly discuss observations. Each incident of a suspected wrongful act, whether evidenced by a formal submission to the Agency, an informal document, or a verbal communication, should be reported and investigated to determine whether it raises a significant question of data integrity or reliability regarding a regulated product.

      If he or she suspects wrongful acts or is asked to participate in or contribute to wrongful acts, promptly discuss those observations or concerns with his/her supervisor. If the employee thinks the supervisor is involved, then he/she should go to the next higher supervisor. The Agency's Office of Internal Affairs welcomes inquiries, but will need to know what steps have been taken within his/her Office to address the issue.

      Review 5 CFR Part 2635, Subpart B, to determine if acceptance of a gift is legal. The regulations, "Standards of Ethical Conduct for Employees of the Executive Branch," have been provided to each employee. If questions remain after reviewing the regulations, contact the Division of Employee Relations, Ethics Branch (HFA-22), Office of Human Resources and Management Services. (See also 18 U.S.C. 201, "Bribery--Penalties for accepting a bribe," 18 U.S.C. 209, "Dual Compensation," and 41 U.S.C. 4.23(b)(2), "Procurement."

      An employee should not assume that an incident is isolated or not important. The Agency takes each observation seriously.
    4. notify his/her immediate supervisor or appropriate Office manager, if a person debarred under the Generic Drug Enforcement Act or a person convicted of a crime related to the development or approval/certification of a FDA-regulated product is involved with an application; and
    5. forward issues requiring discussion to the AIP-C through the appropriate AIP contact person.
  2. Field office or other Agency investigative unit should:
    1. conduct inspections to verify allegations, including the scope and extent, of suspected wrongful acts. If wrongful acts are first uncovered by Field office investigations, notify the appropriate Center AIP contact person of findings as soon as possible. If the Center issued an assignment to investigate suspected wrongful acts, notify the contact listed on the assignment with the results of the investigation;
    2. submit recommendations for withdrawal for each of the affected applications, detailing all specific findings and related exhibits. If the criteria are met, submit a recommendation for invoking the AIP to the appropriate Center OC;
    3. if AIP is invoked, review the firm's proposed audit plan for adequacy, and confirm the completed independent audit information;
    4. evaluate the firm's CAP and provide specific comments to the firm on its adequacy when appropriate. Seek guidance from the Center's OC when needed. Verify implementation and/or completion of the CAP; and,
    5. submit to the appropriate Center, the Field's/investigating unit's recommendation and supporting documentation for revoking the AIP.
  3. Reviewing Office Director should:
    1. ensure that the Office has a procedure to alert the Center's Office of Compliance (OC) when the Center suspects wrongful acts;
    2. notify the Office staff in writing when the Center has either invoked or revoked the AIP. Review should be deferred when the Center invokes the AIP and resumed when the Center either has granted an exception to or revoked the AIP. Ensure that the Office doesn't communicate to the firm observations of suspected wrongful acts or request further information to correct the suspected wrongful acts unless directed by the Center's OC;
    3. ensure that the Office has a mechanism to identify those applications under the AIP so that substantive scientific review is appropriately deferred unless either an exception has been granted to the AIP, or the AIP is revoked;
    4. if authority is delegated by the Center Director, grant or deny an applicant's request for an exception to the AIP and notify the Office staff; and,
    5. transmit a copy of the firm's written request for an AIP exception (see "GRANTING AN EXCEPTION TO DEFERRAL OF SCIENTIFIC REVIEW AFTER THE AIP IS INVOKED") to the AIP contact person. The firm's documentation should describe the basis for the request.
  4. Immediate review supervisors, including division directors should:
    1. defer secondary (supervisory) review of an application subject to AIP when so notified by the reviewing Office Director; and,
    2. resume or begin secondary review of an application subject to the AIP when notified by the reviewing Office Director.
  5. Reviewers or Center consumer safety officers should:
    1. defer primary review of an application subject to AIP when so notified by the reviewing Office Director; and,
    2. resume or begin primary review of an application subject to the AIP when notified by the reviewing Office Director.
  6. Center Compliance Office Director should:
    1. ensure that the Office has a mechanism to alert the Field Office and ORA's Office of Enforceme
    2. review the Field Office/investigating unit's recommendation for invoking or revoking the AIP and provide guidance to the Field Office/ investigating unit on the adequacy of the firm's CAP;
    3. prepare, for the Center Director's signature, the letter to the firm advising it that the Center either has invoked or revoked the AIP. Consistent language in the letters should be used where appropriate (see Attachment B for "model" letters). Notify appropriate headquarters and Field office personnel when the signed letter issues;
    4. when the AIP is invoked, coordinate with the Reviewing Office/divisions to obtain a list of the firm's applications, including those affected by the AIP, and attach it to the letter notifying the firm;
    5. maintain a liaison with the OCC to obtain legal consultation, as needed;
    6. ensure that the scientific review units have verified the number of applications that have been identified by the firm as withdrawn;
    7. notify the appropriate Agency Offices, such as the Office of Criminal Investigations, and the OCC, to:
      1. share discovered facts and observations,
      2. request facts and information that they are authorized to disclose that may assist the Center in its AIP decision, and
      3. discuss the relevance, if any, of "milestones" in court proceedings (56 FR 46191, at 46194, comment 9). An example of a "milestone" is an order issued in a civil proceeding or a criminal conviction, when the order or conviction is based upon a finding of fact that establishes a wrongful act related to the approval process; and,
    8. initiate and monitor administrative and legal action(s), where appropriate, in conjunction with relevant FDA and non-FDA government offices.
  7. Center Director should:
    1. sign the letter to the firm advising it that the Center has either invoked or revoked the AIP;
    2. ensure that the Center has a procedure to implement the AIP, which includes granting or denying an applicant's request for an exception to the AIP; and,
    3. designate a Center AIP contact person(s).
  8. AIP contact person(s) (see Attachment A) should:
    1. as a member of the AIP-C, participate regularly and actively to discuss and participate in consensus-building when confronted with an issue that will promote the goal of consistent implementation of the AIP across the Agency;
    2. if a Center contact person, maintain a current list of applications subject to the AIP by each Center;
    3. distribute the Agency policy and appropriate Center procedure statements on AIP to personnel it represents within the Agency; and,
    4. The AIP-C chairperson should:
      1. prepare an agenda for each AIP-C meeting, and
      2. ensure that the AIP contact persons receive the agenda and minutes for each AIP-C meeting, and based on the information provided by the AIP contact persons, an updated list of all firms whose applications are subject to the AIP.
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