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Compliance References
Regulatory Procedures Manual 2008
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     5-2-1 - Purpose
     5-2-2 - Authority
     5-2-3 - Preparation
     5-2-4 - Respondents' Request for Special Information
     5-2-5 - Conducting the 305 Meeting
     5-2-6 - Procedures after Meeting


5-2-1 - Purpose

This section summarizes the authority, policies, and procedures pertaining to the opportunity, under Section 305 of the Act, for a person to present their views before criminal prosecution is recommended to a United States Attorney.

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5-2-2 - Authority

The Secretary of Health and Human Services delegates broad authority to the Commissioner of Food and Drugs under 21 CFR 5.10, and, unless specifically prohibited, gives the Commissioner the authority to redelegate this authority. District Directors, Regional Food and Drug Directors, and Directors and Deputy Directors of the centers, are authorized under 21 CFR 5.28(a), to designate officials to hold hearings under section 305 of the Act. A Compliance Officer has authority to hold Section 305 meetings by such designation.

21 CFR 7.85 provides requirements about the conduct of such meetings.

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5-2-3 - Preparation

Except in unusual circumstances, the Compliance Officer who holds the meeting is the individual who issued the Section 305 Notice. As there is normally a time lapse between the issuance of the Section 305 Notice and the meeting date, the Compliance Officer should review the case immediately prior to the meeting. The Compliance Officer will need to be completely familiar with the charges, the law and regulations, and fully understand any analytical results and methodology that are part of the case (if necessary, through discussion with the analyst).

The Compliance Officer should assemble any necessary references, such as the Act, regulations, official compendia, etc. The Compliance Officer may also wish to mark or photocopy pertinent information in the files to avoid searches for data during the meeting. Such information may include records relating to samples, EIRs, and FDA 483s, and documents relating to prior warnings to the firm or individuals in the form of citations, seizures, prosecutions, office interviews, letters, etc. To avoid the need to reread all of the material, it is best to organize this information at the time of the initial review, when preparing the Section 305 Notice.

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5-2-4 - Respondents' Request for Special Information

Respondents, their attorneys, and others occasionally attempt to obtain detailed information concerning the government's case. Such requests constitute requests for information under the Freedom of Information Act (FOIA). Point out that under the FOIA, they must submit requests in writing to the Director of FDA’s Division of FOI. Refer the requester to http://www.FDA.Gov/FOI/FOIA2.htm, and mention that the request must be processed according to law and FDA’s procedures. For example, FDA’s Associate Commissioner for Public Affairs might determine that some or all of the information about FDA’s case may be withheld from disclosure under 21 C.F.R. 20.62 (pre-decisional information, attorney work product, etc.) and/or 21 C.F.R. 20.64 (open investigatory, personal privacy, confidential source, etc.).

NOTE: If a respondent requests a portion of a sample, follow the procedures set forth in 21 CFR 2.10(d) and 2.10(c).

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5-2-5 - Conducting the 305 Meeting

Respondents are occasionally quite upset due to the receipt of the Section 305 Notice and may tend to be discourteous or argumentative. The 305 meeting is not a debate and nothing can be gained by the Compliance Officer losing objectivity or by the respondent becoming abusive. The Compliance Officer should politely point out that the proceedings are not a trial but rather an opportunity for the respondents to give their side of the story and discuss any mitigating circumstances, corrective actions taken or planned, etc., and that FDA will consider this information when deciding whether or not to forward the case to the Department of Justice for the institution of criminal proceedings.

The Compliance Officer should strive for continuity and relevancy. Some respondents may digress into time-consuming, irrelevant or repetitious discussion unless there is a diplomatic effort to focus upon relevant matters. Listed below is a suggested routine format for achieving orderly progress during the meeting:

  1. Identification Of Respondents
    After the respondents have been introduced and seated, make notes showing the name, address, position, and business connection of each respondent. The notes are for ready reference during the meeting and useful during the dictation of the Record.
  2. Failure Of Respondent To Appear
    Frequently, a cited individual does not attend the meeting. Determine if anyone present purports to represent such respondent and enter any responses into the record.

    Designated representative(s) must have a signed written statement of authorization for each respondent for whom he/she has authority to act. If a representative appears without written authorization, the meeting may proceed with respect to any respondent for whom the representative appears, only if the Compliance Officer first verifies by telephone, or other appropriate means, the authenticity of the representative’s authority (21 CFR 7.84(g)).
  3. Attendance By Individuals Not Cited
    Occasionally, an individual who was not named in the Section 305 Notice will appear and, during the course of the meeting, it will become apparent that the person shares the responsibility for the violation. In such instances, request a short delay and have the legal clerk prepare a supplemental Section 305 Notice including the individual's name, present it to him/her, and proceed with the meeting.

    Respondents may arrive at a meeting accompanied by many adherents. When this situation occurs, the Compliance Officer should have each person identify themselves by name, state their relationship to the respondent, and, for the record, state that they are attending on behalf of the respondent. The Compliance Officer should then announce to the group that the meeting is not open to the public, that it concerns only the respondent, and that the only legitimate business other persons have in being there is that they are there at the request of, and on behalf of, the respondent; otherwise, they may not be present. Afterwards, the Compliance Officer will hear comments from all persons remaining present. If these actions are not taken, the respondent may claim that FDA deprived him/her of his/her rights to fully respond and explain.
  4. More Than One Respondent
    Requests for separate meetings should be in writing and should be received at least three working days before the date set in the notice (21 CFR 7.84(e)). However, if there is more than one respondent, advise the respondents in advance that they are entitled to separate meetings if they so wish.
  5. Legal Status Sheet, Form FDA 454
    Ask for the Legal Status Sheet. The respondent may complete the sheet before or at the meeting. However, you may not demand completion or submittal of the sheet since there is no legal requirement that respondents furnish the sheet.
  6. Explain The Purpose Of The Meeting And The Charges
    Although the Information Sheet (Form FDA 466a), which accompanies the Section 305 Notice and Charge Sheet, contains information concerning the reason for the notice, the Compliance Officer should reiterate the purpose of the notice prior to the discussion of the charges and advise the respondents that:
    1. The meeting is being held in accordance with Section 305 of the Act to give them an opportunity to present any facts they believe are relevant prior to the FDA making its decision whether to recommend prosecution to the Department of Justice; and,
    2. The purpose of the meeting is not to resolve conclusively whether violations occurred, and therefore FDA will not present either witnesses or evidence at the meeting.
    The Compliance Officer should briefly state the information in the FDA's possession, which indicates that violations of the Act (and other laws, if pertinent) occurred and that the individuals listed in the Section 305 Notice were responsible, either through their actions or their failure to take action. This may be by reference to the pertinent inspections, FDA 483s, warning letters etc., to provide a brief summary of the relevant time and acts. Request that the respondents follow their copies of the Section 305 Notice and Charge Sheet as the Compliance Officer either reads verbatim or summarizes the pertinent information concerning the shipment or receipt of each product and the charges pertaining to it, or the acts that constitute violations.

    The Compliance Officer should ask the respondents whether they understand the charges. If the response is negative, answer any questions to ensure that the respondent understands the basis of the allegations. If the respondent indicates that the shipping or receiving dates are incorrect, clarify the discrepancies. If they indicate that they will make no admissions with regard to the shipment or receipt of the products, do not pursue the matter.
  7. Miranda Warning
    In the past, there were questions regarding whether the Compliance Officer needs to give the "Miranda Warnings" prior to conducting a Section 305 meeting. They are not to be given.

    In Miranda v. Arizona, the court ruled that when an individual is taken into custody or otherwise deprived of his freedom and subjected to questioning, the person must be notified of his right to remain silent, that anything he says may be used against him, and that he has the right to an attorney. This warning does not apply to Section 305 meetings because a respondent to a Section 305 Notice is not "taken into custody or otherwise deprived of his freedom." In addition, even though not required, FDA notifies the respondents (Form FDA 466a) that they are not compelled to answer and that an attorney may represent them. In 1976, in Beckwith v. United States, the Supreme Court held that even when the investigation has "focused" on an individual, he is not entitled to Miranda warnings unless he is in custody. In Oregon v. Mathiason, decided in January 1977, the Supreme Court held that a meeting at which the individual was free to leave did not require Miranda warnings.
  8. Respondents' Statement
    After discussing the purpose for the meeting and the charges, the Compliance Officer should invite the respondents to state their views with respect to the alleged violations. Take notes regarding the various points covered by the respondents to ensure that pertinent comments are not inadvertently omitted when the summary is dictated.

    Occasionally respondents appearing at a meeting present a prepared written response. In such instances the Compliance Officer should, if practical, read the written response aloud while the respondents follow their copies. The Compliance Officer should ask questions regarding any points that need clarification. In the dictation of the meeting summary, refer to the written response, which will be attached to the record as an exhibit, indicate that it was read aloud in the presence of the respondents, and include in the dictation only information concerning the points discussed for clarification.

    Each respondent may present any information bearing upon the issues. This may consist of proposed or revised labeling, letters, laboratory data, sanitation contracts, etc. Identify each exhibit submitted by respondents at the meeting with the related sample number, date received, and the Compliance Officer’s initials. Place the identification at the top right hand corner of the exhibit, if it is possible to do so without obscuring any material.

    Respondents may request that the Compliance Officer comment on the adequacy of the proposed corrections. Unless headquarters provided specific instruction, refrain from commenting, and explain that comments may be provided after careful consideration of the submitted material and that it may involve headquarters review. Advise the respondents that the information will be included in the record as an exhibit.
  9. Ensure Scope Of Respondents' Responsibility
    Usually respondents demonstrate their responsibilities while expressing their views with respect to the alleged violations. Normally, they express responsibilities in the form of comments such as "I hired extra men for sanitation" or "I ordered the destruction of the merchandise" etc.

    If there are any doubts about the responsibility of any of the respondents, ask questions to ensure that you are not including individuals in a criminal proceeding who lack the authority to detect, prevent or correct violations. For example, ask who had the authority to change pest control firms or consulting laboratories, who hires or discharges employees for sanitation or quality control work, who directs labeling changes, and who expends monies for structural repairs and the purchase of new equipment, etc.

    In addition to the responsibility of those who appear, the Compliance Officer may need to make inquiries regarding the responsibilities of an individual listed in the Section 305 Notice who does not appear. This could be particularly important in cases where officials of a company at a location other than the one inspected have been cited, but do not appear at the meeting.
  10. Guaranties
    Unless a respondent voluntarily includes as part of his presentation a guaranty related to the violations, explore thoroughly the question of whether one exists. Otherwise, the respondent may overlook the fact that he/she had a guaranty, until he/she or his/her attorney eventually presents it as a defense at trial.

    If a respondent requests information regarding guaranties so that he/she may obtain them in the future, furnish a copy of 21 CFR 7.13.

    If the respondent presents a guaranty at the meeting, do not comment upon its validity. Tell the respondents that the validity of the guarantee will be reviewed after the meeting.
  11. Summary
    At the conclusion of the meeting, the Compliance Officer will dictate an accurate summary of the meeting in the presence of the respondents, or at their option, immediately after their departure. The respondents, for a variety of reasons, may wish to leave the meeting before the summary is dictated, and should be afforded that option. In that event, a draft copy of the summary should be forwarded to the respondents, requesting their comments within 10 days, and explaining that without benefit of comment the record will stand as drafted. In the event respondents remain during the dictation, they should be offered an opportunity to provide additional comments or corrections. Inform the respondents that if they disagree with, or wish to clarify, any of the statements they may do so after dictation of the summary.

    If respondents undertake to have long or irrelevant statements included in the dictated summary, tactfully suggest that they may wish to submit a statement after the meeting, and that the statement will be included as an attachment to the Record. (21 CFR 7.85(g)).

    1. Required Statements
      The Summary should always contain statements to the effect that:

      1. The purpose of the meeting was discussed with the respondents and they understood that it was being held pursuant to Section 305 of the Act;
      2. The charges were discussed with the respondents and they understood them;
      3. The respondents indicated that the shipments had been made, or received, as alleged. (If not admitted, or they have reservations, this information should be included);
      4. Information concerning the statements each respondent made concerning his scope of authority (responsibility) at the firm;
      5. The respondents were asked if they had any corrections or comments to make (followed by their statements or a comment in the record that they had none);
      6. Copies of the Summary will be forwarded to the respondents; and,
      7. (In the final section of the record) that the Summary was dictated in the presence of the respondents and when asked if they felt that the dictation accurately and fairly summarized the discussion they indicated that it did (or did not in the following respect). If the respondents elected not to remain during the dictation of the summary, the final section of the draft should reflect that fact.

      A copy of the typed summary should be provided to each respondent, and should be accompanied by a cover letter, which states that the firm and individuals have an opportunity to make any additions or corrections in writing within 10 days after receipt.
    2. Addendum to the Summary

      Occasionally after the respondents have left the premises, the Compliance Officer will realize that significant information was omitted from the Summary. In such a case, an addendum to the Summary should be dictated and mailed to the respondents along with the Summary dictated in their presence. A cover letter should accompany the Summary and addendum pointing out the inadvertent omission. Request a letter from the respondents within 10 days indicating that the additional information had been discussed as recorded in the addendum.

      A respondent may request that the meeting be reopened in order to submit new information for the record. Such a request must be timely, in writing, state the nature of the new information, the reason it was not previously available at the time of the original meeting and why the information cannot be submitted in documentary form. If the district concludes that the meeting should be reopened to receive the new information, it may do so.

      On occasion, respondents will request an additional meeting at headquarters to discuss the matter further. Such meetings are an extension of the Section 305 meeting and are governed by the procedures of this chapter.
    3. Verbatim Transcript of Meeting

      The respondent has the right to a verbatim transcript, at his expense. If exercising this right, the respondent must provide the necessary person or equipment to make the transcript. The respondent must submit a copy of such transcription to the district at no cost with an opportunity to make corrections and obtain agreement as to its accuracy. Under these circumstances, the Compliance Officer need dictate only a brief in-house summary after departure of the respondents, explaining the circumstances under which the verbatim transcript was made, who was present, etc. In this case, FDA does not prepare a "Summary".

      The Compliance Officer may also order the meeting transcribed at FDA's expense. In this case, a copy of the transcription is provided to each respondent (21 CFR 7.85(e)).
    4. Handling of Electronic Recording

      If the meeting statement has been recorded, after transcribing, appropriately identify the recording medium with the date of the meeting, the name of firm cited, the sample numbers, and the transcriber's name. File the recording in the lead sample jacket and retain it until the 10-day period for review by the respondent has expired, then remove and destroy, or erase the recording.
    5. Preparation of Summary
      1. Method of Preparation
        • Prepare the summary as a separate document, using the format in Exhibit 5-6 as an example.
        • Include the following statement at the bottom of the copy provided to each respondent:

          "Copy of this Summary (or transcript) furnished to (respondent).”
        • Include the transmittal letter advising respondents of the 10-day period for additions or corrections.
      2. Number of Copies - Make sufficient copies for the following distribution:
        • Original + 1 copy for center (hold for submission with case)
        • One copy for district case file
        • One copy for district establishment file on firm
        • One copy for Resident Investigator, if desired
        • One copy for district reading file
        • One copy for each respondent
  12. Multi-Session Meetings
    The intent of the regulations is to limit multi-session meetings. Requests for changes in time and place of the meeting must be made in accordance with 21 CFR 7.84(e). New evidence may be submitted in accordance with 21 CFR 7.85(g). Nevertheless, a respondent may appear for a meeting, but claim he/she has further evidence to submit. If the request is reasonable, recess the meeting until a mutually agreeable date. Prepare only one Record covering both meetings.

    When the respondent merely requests an opportunity to submit supplemental documentary evidence without further personal appearance, he/she may do as provided in 21 CFR 7.85(g). Mark additional information and/or documentation that is received within ten calendar days after respondents’ received their copy of the summary or transcription of the meeting as an exhibit and add it to the Record.
  13. Response By Mail
    Frequently, respondents elect to respond in writing in lieu of making a personal appearance. It is not necessary to acknowledge receipt of a written response. However, it may be desirable to acknowledge a written response when you also need to clarify some point of misunderstanding or oversight on the part of the respondent.

    Hold correspondence to a minimum to avoid "holding a meeting by mail."

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5-2-6 - Procedures after Meeting

After the meeting (or written response, if any), a decision must be made as to disposition of the charges for each sample involved. The charges are disposed of by one or a combination of the following actions: Permanent Abeyance, Temporary Abeyance, or Prosecution.

  1. Reporting Permanent Abeyance And Temporary Abeyance Cases

    The district should process cases designated as in abeyance within seven days after the meeting, with notification to the appropriate center, as described below.

    1. Permanent Abeyance

      Prepare a memorandum to the appropriate center(s) compliance office, headed "PA after CITATION" which provides the reason for placing the case in permanent abeyance (PA) and the planned district follow-up. Attachments should include a copy of the Section 305 Notice endorsed "PA (date and initials)", a copy of the Charge Sheet, a copy of the Summary, and any relevant information. Hold all copies the above documents in the district case file.

      Forward a copy of the memorandum to the center(s), an endorsed "PA (date and initials)" copy of the Section 305 Notice, and a copy of the Charge Sheet to the district establishment file.

      The Home District’s Compliance Branch should update the Sample Disposition record(s) in FACTS with the appropriate information about the status of the samples.

    2. Temporary Abeyance

      Prepare assignments for necessary follow‑up and forward copies to the appropriate center(s) compliance office.  Hold the file in the District Compliance Branch.  A case in TA is not considered closed.

  2. Notification Of Non-Prosecution

    When the Agency makes a final determination that prosecution will not be recommended for any of the persons named in a notice (i.e., the case is closed), the district that issued the 305 Notice will advise each person in writing of that fact (21 CFR 7.85(h)(1)).

    After the Agency decides to decline prosecution, that decision must be communicated to the office (generally a district office) that originated the citation recommendation to ensure that notification of non-prosecution issues in accordance with regulations. The FDA unit to which the recommendation was made, e.g., center, OE, OCC, is responsible for issuance of the declination to the originating office/district. Upon receipt of the declination, and absent a request for reconsideration of the recommendation, the originating office/district should issue the notification of non-prosecution within 10 working days.

    When it is determined that one of several persons named in a notice will not be included in a recommendation for criminal prosecution, the Office of Chief Counsel (OCC) will determine when that person will be notified (21 CFR 7.85(h)(2)). The Office of Chief Counsel will notify the district of this fact, and the district will issue the letter. The latter procedure applies when the Department of Justice declines to proceed with the entire case (21 CFR 7.85(h)(3)) or declines to proceed against an individual (21 CFR 7.85(h)(4)). See Exhibit 5-7 for the model letter to use.

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