CHAPTER 10

OTHER PROCEDURES

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SUBCHAPTER - PRIOR NOTICE
Purpose...........................................................375
Background........................................................375
Policy............................................................375
Procedures........................................................376

SUBCHAPTER - EIR CONCLUSIONS AND DECISIONS 
Purpose...........................................................376
Background........................................................376
Discussion........................................................376
Policy............................................................376
Inspection Conclusion.............................................376
DistrictDecision.................................................377
Procedures........................................................378
Compliance Officer Review.........................................379
Inspections Conducted by State Personnel..........................379

SUBCHAPTER - ITS AND SUPPORT FACILITIES CLASSIFICATION/ADMINISTRATIVE ACTIONS 
Approved/NAI/VAI..................................................379
Provisional/OAI...................................................379
Not-Approved/OAI .................................................380

SUBCHAPTER - REPORTING AND MONITORING 
Purpose ..........................................................380
Responsibilities .................................................380
Procedures........................................................381

SUBCHAPTER - AD HOC COMMITTEE 
Purpose...........................................................382
Background........................................................382
Function..........................................................382
Composition.......................................................382
Procedures........................................................383
Responsibilities..................................................383

SUBCHAPTER - APPEAL PROCESS 
Purpose...........................................................384
Who May Appeal....................................................384
What may be Appealed..............................................384
Appeal Is Not Appropriate.........................................384
Requests for Appeal...............................................384
Review of Appeals ................................................384
Decisions on Appeals..............................................384 

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SUBCHAPTER

PRIOR NOTICE

PURPOSE

This chapter defines "prior notice" and establishes uniform criteria to determine if prior notice has been achieved.

BACKGROUND

A basic precept of FDA enforcement policy is the belief that the majority of persons desire to comply with the law, and will comply voluntarily when given information as to what is required and what violations appear to exist. Therefore, it is agency policy that responsible persons to be given notice of their violative conduct and afforded an opportunity for correction provided that the situation does not present a danger to health, or does not constitute intentional, gross or flagrant violation.

The Food and Drug Administration is under no legal obligation however to warn firms or individuals that they or their products are in violation of the law prior to taking formal regulatory action. Nevertheless, documentation of notice of violative conduct strengthens the agency's position in regulatory actions by establishing that responsible individuals continued violative conduct despite warnings by the agency.

POLICY

Prior notice means that responsible persons have been advised of conduct which is in violation of the laws enforced by the Food and Drug Administration.

The following criteria must be met and documented to assure adequate prior notice has been given:

1. Responsible persons have been advised.

2. The violative conduct has been adequately identified.

3. The conduct describes violates law enforced by FDA.

4. A reasonable amount of time to implement corrections has been given.

All criteria must be met to assure adequate prior notice.

Compliance with these provisions of prior notice assures meting the requirements of injunctions and certain criminal actions.

PROCEDURES

"Prior Notice" includes a Warning Letter, civil suit, or administrative action. In addition, "Prior Notice" may be given in less formal ways. The following are examples:

1. Notification by state, municipal, or other Federal agencies involving the same or similar violations.

2. FDA-483, List of Observations provided by and FDA investigator at the conclusion of the inspection provides notice to the person who issued. Issuance of a copy of the FDA-483 to a firm's most responsible person(s) should follow guidance in FMD 120.

3. Discussion of objectionable conditions by and FDA investigator, clearly documented in the EIR.

4. Verbal notification form agency officials to a firm's top management, for example meetings or telephone conversations, confirmed in writing.

5. Advisory communication by FDA Center personnel involving critical scientific issues.

6. Industry meetings during which pertinent violations are discussed if attendance by a firm's management is documented.

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SUBCHAPTER

EIR CONCLUSIONS AND

DECISIONS

PURPOSE

The purpose of this subchapter is to provide definitions and procedures for assigning Investigations Branch conclusions and District Office decisions to an Establishment Inspection Report (EIR).

BACKGROUND

The Field has traditionally had guidelines based on nationally established policy for the classification of EIRs. These were originally contained in the Regulatory Procedures Manual and were placed in the PODS Handbook on July 1, 1969. They are also presently published as Field Management Directive (FMD) No. 86.

DISCUSSION

Since the compliance status of EIRs has broad ramifications and impacts directly on critical public health issues, the classification process must be both accurate and uniform. The last revision to these procedures (May 1994) were modifications of the previous EIR classification system and were designed to bring greater uniformity in interpretation and decisions.

Instead of three Voluntary Action Indicated (VAI) categories, there are now only one VAI category. The one VAI category will contain all EIRs that previously would have been classified as VAI-1 or VAI-2 and those in VAI-3 that did not result in Warning Letters or other administrative action. All EIRs that result in Warning letters are now to be classified in the Official Action Indicated (OAI) category whereas before such Warning Letters could have been either VAI-3 or OAI.

Investigation Branches are now allowed to give final District Decisions for all classifications. District Compliance Branches may change a District Decision of OAI to VAI if a district decides that no administrative or regulatory action will be taken or recommended.

POLICY

Domestic and foreign EIRs for all programs will be classified to reflect the compliance status at the time of the inspection and the District's decision or recommended administrative or regulatory action.

INSPECTION CONCLUSION

The inspection conclusion is decided by Investigations Branch and represents whether objectionable conditions were found during the inspection or not. This column is also used to record the appropriate code when an inspection was attempted but not conducted. If an EIR covers more than one Program Assignment Code (PAC), there may be more than one inspection conclusion. Definitions are as follows for "Inspection Conclusions":

CODE/TITLE: N - No Action Indicated (NAI)

DEFINITION: No objectionable conditions or practices were found during the inspection.

CODE/TITLE: A - Correction Indicated (CI)

DEFINITION: Objectionable conditions or practices were found during the inspection.

CODE/TITLE: B - Referred to Center (RTC)

DEFINITION: A temporary conclusion showing that the EIR has been referred to the appropriate Center for the permanent Inspection Conclusion and District Decision.

CODE/TITLE: T - Not Official Establishment

Inventory (NOT OEI)

DEFINITION: The establishment has ceased business in commodities FDA regulates and should be removed from the Active OEI.

CODE/TITLE: V - Out of Business(OOB)

DEFINITION: The establishment has ceased to exist as (OOB) an identifiable organization and should be removed from the Active OEI.

CODE/TITLE: R - No Inspection Made (NIM)

DEFINITION: An inspection was attempted at an establishment with a Central File Number but was not conducted because the establishment had moved, or was not in operation, or the product/process was not available.

DISTRICT DECISION

The District Decision represents the action that the District will take after considering the findings found during the inspection, any events that occurred following the findings, and Agency policy. The Investigations Branch and Compliance Branch will be responsible for assigning District Decision codes to EIRs as outlined in the PROCEDURES section of this subchapter (below).

The following District Decisions will be used as appropriate according to their definitions. (These definitions will be included in the ORA Data Codes Manual, Inspection Conclusion/District Decision Section). Codes marked with a "*" are not entered by district personnel, but are assigned by computer programming based on entries in the Inspection Conclusion column. This is done as an aid for data analysis. Definitions are as follows for "District Decisions":

CODE/TITLE: N* - No Action Indicated (NAI)

DEFINITION: Assigned by computer programming based on an "NAI" Inspection Conclusion.

CODE/TITLE: E - Voluntary Action Indicated (VAI)

DEFINITION: Objectionable conditions are found but the District is not prepared to take or recommend any administrative or regulatory action. The District may advise the establishment following the inspection of findings that should be corrected, but the significance is not such to warrant warnings of administrative or regulatory actions or to request a response. Any corrective action is left to the establishment to take voluntarily. Recalls initiated by the firm would be VAI.

CODE/TITLE: A - Official Action Indicated (OAI)

DEFINITION: Regulatory and/or administrative sanctions will be recommended.

CODE/TITLE: I - Referred To State (RTS)

DEFINITION: Referred to State, local, or other federal office.

CODE/TITLE: T* - Not Official Establishment Inventory (NOT OEI)

DEFINITION: Assigned by computer programming based on a "Not OEI" Inspection Conclusion.

CODE/TITLE: V* - Out of Business (OOB)

DEFINITION: Assigned by computer programming based on an "OOB" Inspection Conclusion.

CODE/TITLE: R - No Inspection Made (NIM)

DEFINITION: Assigned by computer programming based on a "NIM" Inspection Conclusion.

CODE/TITLE: P - Referred to Center (RTC)

DEFINITION: Assigned by computer programming based on a "RTC" Inspection Conclusion.

PROCEDURES

SUPERVISORY INVESTIGATOR REVIEW

The supervisory investigator reviews the EIR to determine if all information necessary to draw a conclusion is included. If it is, an Inspection Conclusion is assigned. When necessary information has not been obtained, the supervisory investigator will take the appropriate action as required by the District.

1. "No Objectionable Conditions or Practices Found" Inspections

If the supervisory investigator concludes that no objectionable conditions or practices were found during the inspection, the code "N" shall be entered as the Inspection Conclusion on the EIR coversheet, and the District Decision is left blank. The FDA-481CG (or a copy) will be routed to the Data Processing Unit (DPU) for data entry.

2. "Objectionable Conditions or Practices Found" Inspections

If the supervisory investigator concludes that valid objectionable conditions or practices were found, the code "A" shall be entered as the Inspection Conclusion on the EIR coversheet. The District Decision must then be one of the following:

a) If the objectionable conditions and practices were either corrected by the establishment, or the District is not prepared to take or recommend any regulatory or administrative action, the supervisory investigator will assign the District Decision code "E" (VAI) or "I" (Referred to state, local or other federal office) as is appropriate. The FDA-481CG (or a copy) will be routed to DPU for data entry.

b) If objectionable conditions or practices, including any listed below, are such as to warrant either regulatory or administrative action, the supervisory investigator will assign the District Decision code "A" (OAI). This would include a firm conducting a voluntary recall where the district has decided conditions warrant either regulatory or administrative action. The supervisory investigator will include in the EIR endorsement an evaluation of inspection findings and a recommended action.

      Banning
      Certification Withholding or
            Revocation
      Citation
      Civil Penalty
      Disqualification
      Emergency Permit Disapproved
      Injunction
      License Denial, Suspension, or
           Revocation
      Prosecution
      Provisional Listing
      Recall (FDA initiated recalls)
      Recommendation for Denial for Pending
           Application (NDA, NADA, ANDA,
           PMA, etc.)
      Recommendation for Revocation of
           Approved Application (NDA, NADA,
           ANDA, PMA, etc.)
      Remove from Shippers List
      Seizure/Detention
      Use Prohibited
      Warning Letter 

3. Referred to Center Instructions

The supervisory investigator shall temporarily use the Inspection Conclusion "Referred to Center" (Code B) for any EIR requiring headquarters review prior to reaching the final Inspection Conclusion and District Decision. The supervisory investigator will forward a copy of the FDA-481CG to DPU for data entry at the time the report is forwarded to a Center for their review. This conclusion is to be used only when the compliance program or a policy issuance reserves to a Center the right of such a review. These reports should be monitored to ensure that the final codes are entered in the data system under the fiscal year in which the inspection was made. The District Decision code is left blank on the EIR but will be filled automatically on the computer record.

Do not use this conclusion for a report being forwarded to a Center for concurrence with a regulatory action being recommended by the district or for evaluation and comment.

4. Referred to Office of Criminal Investigations (OCI)

Whenever an EIR is referred to OCI for further investigative follow-up or as part of an OCI case, the report shall be classified as "OAI".

5. Referred to State Instructions

Normally, only violative EIRs for which the Agency either can not or chooses not to take regulatory and/or administrative action are referred to states, since the reason for a referral is usually to request the state to consider some action. A memorandum for referral is normally prepared by the District Compliance Branch. The district is obligated to maintain contact with the state to learn if action is taken.

6. Follow-up Classifications to OAI EIRs

An OAI classification may delay an establishment seeking government contracts or approvals. Therefore, if the previous inspection was OAI and the reinspection is either VAI or NAI, the new classification needs to be reported to DPU ASAP but not to exceed ten working days from the completion of the inspection.

7. Other Instructions

When an inspection cannot be conducted, the supervisory investigator will enter the Inspection Conclusion code for "Not Official Establishment Inventory" (Code T), "Out of Business" (Code V), or "No Inspection Made" (Code R) as appropriate. The District Decision code is left blank on the EIR but will be filled automatically on the computer record.

COMPLIANCE OFFICER REVIEW

When an EIR is submitted to Compliance Branch for consideration of a regulatory or administrative action and the Compliance Branch finds that no action by the Agency is warranted, the District Decision recorded on the coversheet of the EIR should be changed to either a "VAI" or "RTS" decision. The change in classification must be documented for the file, and the District DPU should be notified to change the computer record.

INSPECTIONS CONDUCTED BY STATE PERSONNEL

Assignment of uniform classifications to state inspections performed under FDA contracts or agreements are essential to the success of these programs. State officials responsible for submitting EIRs to FDA are to be furnished with copies of this FMD and be instructed in the use of these criteria. Copies of any other pertinent guidelines and programs shall be furnished.

Do not consider violations of state law or regulations that are not actionable under current FDA policy, in reaching conclusions or decisions on EIRs although these violations will be followed up under the state's own program.

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SUBCHAPTER

ITS CLASSIFICATIONS AND ADMINISTRATIVE ACTIONS

APPROVED/NAI, VAI

An APPROVED classification may be assigned when the establishment is found, with few exceptions, to comply with FDA sanitation requirements. The sanitation rating should be 85 or above, with all minor violations corrected as soon as possible, but no longer than the next routine inspection. Corrective action on a "critical item" should take place during the inspection period *or immediately thereafter, with the acceptance of the FDA specialist.* The following additional criteria should be used:

1. Assigned an NAI *Inspection Conclusion and District Decision* when the facility is in compliance with FDA requirements.

2. *Assigned a CI (Correction Indicated) Inspection Conclusion and a VAI District Decision* when only a few minor violations are found, the establishment has made voluntary corrections, and the firm is likely to remain in compliance.

3. *Assigned a CI Inspection Conclusion and a VAI District Decision* where minor violations are found, the establishments has made partial voluntary corrections, and minor violations remain which cannot be corrected immediately, but will be corrected by the next inspection. Where "critical item" violation is found, it should be corrected during the inspection period (the more serious violations generally warrant a PROVISIONAL/*OAI* classification).

PROVISIONAL/OAI

A PROVISIONAL classification may be assigned when a sanitation rating falls between *70* and 84 and/or a "critical items(s)" is violative.

A facility should not generally retain a PROVISIONAL status for more than 30 days. When inspectional findings warrant, a shorter period may be assigned. For example, if one or more "critical item" are in violation, they should be corrected as soon as possible, but generally within 10 days. Similarly, an extension of the time period may be given when the items in violation are substantially corrected during or shortly after the inspection.

A PROVISIONAL classification may also be assigned when there is epidemiological or other evidence that a facility is associated with passenger, crew or employee food-borne or other diseases of public health importance in the Interstate Travel Sanitation Program area.

This classification may be assigned on an interim basis to an establishment which is resuming operation after a period of NOT-APPROVED classification.

*Note - For all Provisional classifications, enter "ITS-Provisional" in the "PRODUCT" (product description) field on the FDA 481A.*

NOT-APPROVED/OAI

A NOT-APPROVED classification may be assigned to a facility when one or more of the following conditions exist:

1. The establishment has a sanitation rating less than 70.

2. An imminent health hazard exists.

3. There is epidemiological or other evidence that the continued operation of an establishment will have a direct or substantial indirect bearing on the transmission of food-borne disease or other disease of important in the Interstate Travel Sanitation Program area.

4. The establishment has been on PROVISIONAL status for a specified time period and there has been on significant improvement in the sanitation level; or the establishment has as a history of repeated PROVISIONAL classifications.

An establishment so classified should be reinspected *after being contacted by the establishment person-in-charge and after FDA has been assured that* only if there is evidence that the facility can be operated in accordance with good sanitation practices.

*Facilities classified as NOT-APPROVED are to be considered USE-PROHIBITED by interstate carrier companies. The district(s) should investigate the acceptability of carrier alternative food sources/operations which are the result of a NOT-APPROVED action.*

*Note - For all Not Approved classifications enter ITS-Not Approved" in the "PRODUCT" (product description) field on the FDA 481A.

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SUBCHAPTER

REPORTING AND MONITORING

PURPOSE

To establish uniform procedures for monitoring and reporting the activities on regulatory actions. To set forth responsibility for monitoring actions for the agency.

RESPONSIBILITIES

ORA/OFFICE OF ENFORCEMENT (OE)

Responsible for periodic evaluating, summarizing, and reporting agency regulatory accomplishments and enforcement activities. Provides the press office with information on legal actions filed in the field.

CENTERS

Responsible for tracking each action recommendation they receive and responding to the field on each recommendation. Provides information copies of all actions initiated by the center to the appropriate field office in a timely manner.

DISTRICT OFFICES

Responsible for the timely reporting of all legal and administrative action activities into the ORA management information system. For promptly reporting the filing and subsequent update activities for all approved legal actions to ORA/OE.

PROCEDURES

DISTRICT OFFICES

Each district office will enter data into the ORA management information system (MIS), following the instructions in the current FDA Data Code Manual, when any of the following actions are recommended by the district and will update the MIS record when there is any subsequent activity on that action (such as, approval or disapproval, filing in court, seizure accomplishment, close out, etc). Seizure (direct reference or recommended), Injunction (routine or non-routine), Prosecution (routine or non-routine), 305 meeting (citation, direct or recommended,Civil penalty, Suspension or revocation of a license or other items, i.e. certification, NDA, IND, etc., Emergency permit, Banning, Disqualification (ITS use prohibited, clinical investigator, etc.), Warning letter, Notice of findings letter, and Import detention or release with comment.

When the district has received notification that an action has been filed in court, the following information will be promptly transmitted to Division of Compliance Management and Operations (DCMO - HFC-210).

PROSECUTION OR INJUNCTION (SPECIFY WHICH)

1. Against - Include full name and address of firm, name and title of each individual.

2. Charges - A brief description of what is being charged. (For example: "Adulteration, product contains insect fragments and was held under insanitary conditions").

3. Product - Include specific name(s), or if more than five item state "stored food" or "various drugs".

4. Filed - Include date filed, court jurisdiction, FDC number, court reference number, and lead sample number.

SEIZURE

1. Product - Specific name if possible

2. Charge - A brief description of what is being charged (see example above).

3. Firm - Give the name and address (city and state) of the firm responsible for the violation.

4. Filed - Include date filed, court jurisdiction, FDC number, court reference number, and lead sample number.

NOTE: When reporting the above information to DCMO (HFC-210) on a specific case, please include the name of the investigator(s), analyst(s), and/or other district personnel who were involved in the case.

The district will submit written update information on each active case in the district until that case has been closed. Report the following update information when there is any activity subsequent to filing, such as: seized, consent decree, goods reconditioned, etc. OE will keep the responsible center advised of case progress. District, Firm name and product, FDC number or other assigned case number (Inj. etc.), Date activity occurred, A brief description of the activity and summary of even leading to or related to the activity, and Value: Include the dollar value and the of goods seized.

NOTE: When reporting updates, please include the names of district personnel who were involved in the case.

The MIS will also be kept current by the districts for: Center initiated administrative and or legal actions at the time when the district receives their copy of the said action and, Filed cases (seizure, prosecution, injunction etc.), the district will enter the update information for the case from filing through adjudication and close out.

NOTE: Refer to the current FDA Data Codes Manual for reporting guidance.

Appealing a turndown or requesting an ad hoc meeting: See RPM subchapters Appeal Process on page 384, and Ad Hoc Committee on page 382.

CENTERS

Each center will establish and maintain a record system which is capable of supplying the following information for each case recommended by the field or which is initiated within the center. Firm name and address, District, Type of action, Date received, Lead sample number (if Known), and Date and center decision (approve or disapprove, etc.).

Each center will submit a summary report of all regulatory actions received and/or taken by the center (including warning letters that originate within the center) to ORA/OE at the end of each month.

Each center will send DCMO (HFC-210) a copy of the decision memorandum on each case received from the field.

The centers will send a copy of each warning letter originating in the center to the appropriate district office and ORA/OE.

OFFICE OF ENFORCEMENT

The OE will develop procedures to report and summarize the regulatory accomplishments of the agency and will prepare status reports on cases pending and/or closed on a periodic basis (e.g. weekly, monthly, quarterly, yearly) as needed by OE or other agency components.

The OE will provide the weekly information on legal actions to the press office for publication in the weekly ENFORCEMENT REPORT.

GENERAL COUNSEL

General counsel (GC) will provide OE and the appropriate district with a copy of all transmittal letters forwarding cases to the Department of Justice (DOJ). GC will also notify OE of any action(s) taken or suggested by DOJ (PREFERABLY EARLY ENOUGH SO THAT OE may have an opportunity to comment) on cases from the time they are sent to DOJ until resolved.

General counsel will work in concert with OE/DCMO to develop summaries of agency legal actions.

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SUBCHAPTER

AD HOC COMMITTEE

PURPOSE

This chapter outlines the function, composition, and activities of agency ad hoc committees, and the responsibilities of the field and headquarters units in recommending, and carrying out the goals of the ad hoc committee.

BACKGROUND

In 1984, an Office of Planning and Evaluation study of the routine and non-routine case procedure disclosed considerable support for the ad hoc committee system from agency managers and case reviewers. This support was based on actual experience in the use of ad hoc committees. An updated 1986 OPE study demonstrated that the use of ad hoc committees expedited the processing of injunctions by resolving issues, planning regulatory procedures, and committing responsible units to an action plan.

FUNCTION

There are two principle types of ad hoc committees, strategy and referral. Strategy ad hocs are used to resolve issues for which agency precedent is lacking or matters that involve complex and difficult enforcement issues such as those described in RPM Chapter 6, page 204, "Development of Felony Violation".

Ad Hoc committees convened to consider the agency referral of a matter to the Department of Justice for further criminal investigations or proceedings are referral ad hocs. See Chapter 6, page 205, "Referrals for Criminal Investigations". While both types of committees can be used at any point in the case development or review process, early identification of the need for an ad hoc committee will expedite decision-making and enable a more prompt review of legal actions. Accordingly, every effort should be made to use this procedure in the earliest stages of an investigation before a regulatory action is recommended or developed.

Ad hoc committees may also be requested to resolved disagreements among Agency components regarding an appropriate regulatory course of action, where enforcement policy is inconsistent, unclear or non-existent. The parties in disagreement should first attempt to resolve the disputed issues between themselves.

The Office of Criminal Investigations (OCI) is charged with the responsibility to review all matters within the purview of this agency for which a criminal investigation is recommended. OCI should be contacted as soon as the district office or center believes that there is a need for criminal investigation. If OCI believes that they would not be interested in the matter at the time, the district or center should proceed as outlined below under RPM page 383, "Procedures".

COMPOSITION

The ad hoc committee will be chaired by the Director, Office of Enforcement/ORA, and will consist of the Regional Food and Drug Director, the appropriate Center Director of Compliance, and the Deputy Chief Counsel for Litigation and the Director OCI, if appropriate. These individuals are considered the "principals." When the principals are unable to participate in a scheduled ad hoc meeting they shall designate a senior compliance official (or attorney) to serve in their absence.

Principals or their designated representatives should be prepared to make agency decisions on the issues based upon the evidence presented prior to and during the ad hoc meeting. Appropriate resource persons may accompany the principals to the meetings, but they should be limited to only those persons who have knowledge of the events or who can significantly help in the decision making process.

PROCEDURES

The meeting will be chaired by the Director of OE. The party requesting the ad hoc will be expected to briefly summarize the reason for the request, the recommended outcome of the committee, describe any foreseeable problems, and provide whatever additional information that would serve useful in reaching a decision.

Requests for an ad hoc committee may originate from a RFDD, district director (with the concurrence of the RFDD), the Center Director of Compliance or its equivalent, the Director, Office of Enforcement, or the Deputy Chief Counsel for Litigation. The requesting office must submit an original and three copies of the ad hoc request and accompanying material to the Office of Enforcement, Division of Compliance Management and Operations (DCMO) HFC-210. Except in case of a genuine emergency, no meeting will be held without at least ten working days to review the accompanying material.

The ad hoc request consisting of an executive summary (no greater than five pages length should include:

o a brief description of the factual background of the case,

o a description of the evidence FDA has in hand,

o if a strategy ad hoc (in addition to those items delineated in Chapter 6, RPM page 204, "Development of Felony Violations"), what is the requesting office's recommendation ?,

o if a referral ad hoc (in addition to what is required by Chapter 6, page 205, "Referrals for Criminal Investigations"), the evidence expected to be gained through the grand jury and why is it necessary to refer the matter to the grand jury instead of continuing with an FDA investigation?

o the options that have been considered (accepted or rejected and why), and

o other reasons for the ad hoc request.

The executive summary should limit its exhibits to the case in point.

All decisions of the ad hoc Committee, including any necessary follow-up, will be recorded and disseminated by the DCMO Case Review Officer to the ad hoc.

The ad hoc committee may be reconvened when significant changes or revisions to the original ad hoc committee decision are being contemplated, when significant new information is revealed that may affect the original decision of the ad hoc committee, or when problems arise that may alter the original decision of the ad hoc committee.

In those situations where it is necessary to reconvene the ad hoc committee, i.e., when additional investigations are mandated, etc., every effort should be made by the original ad hoc principals to attend any follow-up ad hocs. In the great majority of cases, a decision will be made based on a consensus of the members of the committee. Where this cannot be done, the Director, Office of Enforcement, will refer the matter to the ACRA with recommendation for final decision. All committee decisions are subject to review by the ACRA and Chief Counsel and the final decision reached will not be subject to appeal.

RESPONSIBILITIES

Office of Enforcement - will receive the request for an ad hoc committee, check the information for completeness, disseminate informational material to the members of the ad hoc committee, and establish the time and place for the meeting.

The Director, Office of Enforcement - will chair the ad hoc committee and issue the final decision based on ad hoc committee discussion. If no decision can be reached by the ad hoc committee, the issue will be referred to the ACRA for a final decision.

The Regional Food and Drug Director - will approve or disapprove all recommendations for an ad hoc committee from the field. The Regional Director will also serve on the ad hoc committee.

The District Director - may recommend the ad hoc committee and forward the recommendation with appropriate background information through the Regional Director.

The Center Director of Compliance or equivalent, - will approve or disapprove all recommendations for an ad hoc committee from the center and will serve on the ad hoc committee.

The Deputy Chief Counsel for Litigation, Office of General Counsel, will serve or appoint an attorney from the GC staff to serve on the committees requiring legal counsel.

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SUBCHAPTER

APPEAL PROCESS

PURPOSE

The purpose of this document is to set forth a procedure for the appeal of decisions regarding recommendations for legal or administrative actions.

WHO MAY APPEAL

Appeals may be originated by the regional food and drug directors or the center associate directors for compliance (or equivalent). This policy does not apply to non-routine injunction or prosecution cases.

WHAT MAY BE APPEALED

Any decision disapproving a proposed action, administrative or legal, which is based on an allegedly inconsistent, unclear or non-existent enforcement policy, may be appealed. An attempt to resolve the disagreement must, however, be made by the directors of the involved offices prior to submission of an appeal.

APPEAL IS NOT APPROPRIATE

An appeal is not appropriate when additional information which overcomes the basis for the original denial becomes available. In that case, the recommendation should be updated to include the additional information and resubmitted to the center with an explanation for the resubmission and a request for reconsideration.

REQUESTS FOR APPEAL

Districts should submit appeals over the signature of the regional food and drug director. Centers should submit appeals over the signature of the associate directors for compliance (or equivalent). The appeal and two copies of all documents necessary for the review shall be identified, indexed and submitted to the Director, Office of Enforcement (HFC-200).

The appeal memorandum shall state the issues upon which the appeal is based, and the reasons for disagreeing with the decision of the declining unit. Recommendations shall include a summary of communications regarding attempts to resolve differences of opinion.

REVIEW OF APPEALS

The Division of Compliance Policy (DCP), (HFC-230), will review the appeal package to assure that it is complete, and appropriate (see RPM page 384, "What May Be Appealed" and page 384, "Appeal Is Not Appropriate"), and will determine whether the appeal deals with policy, regulations, or a statute. DCP will attempt to identify any policy issue involved in the appeal and attempt to gain a resolution of the disagreement by the parties to the appeal.

DECISION ON APPEALS

If DCP cannot get the parties to agree, then DCP will schedule an ad hoc committee meeting chaired by the Director, Office of Enforcement (HFC-200) and including the regional food and drug director, the center associate director for compliance; and the deputy chief counsel for litigation, if appropriate. The referenced officials should personally attend committee meetings; however, if they are unable to be present, they shall designate a senior compliance official to serve in their absence. Ordinarily only one resource person should accompany the senior compliance official. Unusual circumstances may require additional resource persons. DCP will distribute copies of the background material prior to committee meetings.

All decisions will be recorded and disseminated. The decision may be limited to a decision on the merits of the case or it may include instructions to develop policy in a particular program area. In the vast majority of case, appeals should be resolved by a consensus of the ad hoc committee members. In those rare instances where it is impossible for the ad hoc committee to reach a consensus, it will forward the appeal to the ACRA for a final decision. All committee decisions are reviewable by the ACRA or the Chief Counsel.