CHAPTER 3

OTHER REGULATORY AGENCIES

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CONTENTS

SUBCHAPTER - COMMISSIONING STATE ANDLOCAL OFFICIALS

Purpose..................................45
General Provisions.......................45
Objectives...............................46
Eligibility Requirements.................47
Legal Restrictions and 
   Conflict of Interest Safeguards ......47
Privacy Act..............................48
The Commissioning Process................49
Relationship With Commissioned Officers..51
Acceptance of State Commissions..........52
Record Keeping...........................52
Renewal of Commissions...................53
Non-Renewal of Commissions...............53
Revocation of Commissions................53
Lost Credentials.........................53
Exhibits.................................54

SUBCHAPTER - WORK SHARING AGREEMENT GUIDANCE
Purpose..................................54
Authority for Federal-State Cooperation..54
Policy...................................54
Subject of Agreement.....................55
Authority for Signing....................55
Agreement Format and Content.............55
Reporting Requirements...................55
Exhibits.................................56

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SUBCHAPTER

COMMISSIONING STATE AND LOCAL OFFICIALS

PURPOSE

This Subchapter establishes Food and Drug Administration policies, procedures, and responsibilities for commissioning state and local officials to receive commissions to perform designated activities.

GENERAL PROVISIONS

Commissioning policies and procedures have been developed by the Food and Drug administration to grant specific federal authority to state and local officials pursuant to the following: Section 702(a) of the Federal Food, Drug, and Cosmetic Act (Title 21, U.S.C.) [the Act]; Section 360E(2) of the Public Health Service Act (Title 42, U.S.C.); and authority delegated to the Commissioner of Food and Drugs by the Secretary of Health and Human Services (21 CFR 5.35).

CERTIFICATES AND CREDENTIALS

State and local officials may be commissioned to perform specific functions pursuant to the Act. Officials so commissioned will receive a Certificate of Commission (Exhibit 3-4). In addition, commissioned officers will receive a set of pocket credentials so that they can exercise activities #1 through #3, as identified in the next paragraph. However, under usual conditions, those officials only commissioned for activity #4, to receive and review FDA documents, will not receive pocket credentials.

PROGRAM AREAS

Officials may be commissioned to act in specific program areas corresponding to those covered in the laws administered by the Food and Drug Administration. The program area or areas will be specified on the pocket credentials (see Exhibit 3-3). Program areas specified may include, but not be limited to, the following: Foods, Drugs, Medicated Feeds, Shellfish, Medical Devices, Radiological Health, Biologics, and Cosmetics.

Some officials may be commissioned to act in all program areas. This is often the case if they are commissioned only for the purpose of receiving and reviewing official FDA documents (activity #4). For such officials, in the space for the program area on Form FDA 1990a (Exhibit 3-3), it shall read: All Under The FD& C Act.

RECEIVE AND REVIEW OFFICIAL FDA DOCUMENTS (ACTIVITY #4)

The power granted under this activity is restricted to reviewing materials provided to the official by FDA. No authority is conveyed to review FDA documents which are not specifically supplied to the official for the purpose of his or her review. The commissioned official with this power may have access to trade secrets and commercial confidential information as needed in accordance with the Act and FDA regulations.

Whenever FDA provides a commissioned official, in accordance with the Act and FDA regulation, with a non-public document, the document must be marked "For Official Use Only." The envelope in which it is furnished will be identified "To Be Opened By Addressee Only." See Exhibit 3-5 for a sample of a letter used to transmit such confidential information.

QUALIFICATIONS

The Food and Drug Administration requires that state and local officials selected for FDA commissioning may only be commissioned in areas in which he or she has been determined to be qualified. The matter of qualifications is more fully discussed under Eligibility Requirements, Section C.

CONFLICT OF INTEREST SAFEGUARDS

The conflict of interest safeguards found in this chapter are modeled after the ones in 21 C.F.R. 20.89(c) and have been adapted accordingly. The principle behind the safeguards is to treat state and local government officials as if they were subject to the conflict of interest rules applicable to the Food and Drug Administration advisory committee members under 21 C.F.R. 14.80(b)(1).

The safeguards address the commitment to protect confidential commercial and trade secret information and to certify that no conflict of interest exist.

Candidates seeking commissioning (and Commissioned Officials for renewal purposes) are asked to attest in writing (through the Acceptance of the Commission) that he/she, his/her spouse, or his/her minor child(ren) do not have any personal financial interests or any other financial or business relationships with firms operating in the specific fields where authority would be granted to the official as a commissioned officer.

A written assurance, as obtained through the Acceptance of the Commission, is a prerequisite before non-public information is released to the commissioned official.

A copy of the brochure, The FDA Commission, will contain a detailed explanation of the conflict of interest safeguards.

DURATION

Each commission will be issued for a period of three years. They may be renewed (see RPM page 53, "Renewal of Commissions"); they may not be renewed (see RPM page 53, "Non-Renewal of Commissions"); or may be revoked (see RPM page 53, "Revocation of Commissions").

MANAGEMENT REVIEW

The RFDD will periodically review each commission to determine whether it should be renewed, not renewed, or revoked. Decisions based on this review shall be reduced to writing and a copy of this memorandum shall be sent to DFSR.

ACCOUNTABILITY

In order to maintain a strict accountability for FDA pocket credentials and to make sure that the list of credential holders is up-to-date, the RFDD will make an annual validation of credentials.

A letter similar to that shown in Exhibit 3-8 will be sent to each Agency Head together with a form listing the members of that agency holding credentials (Exhibit 3-9).

After return of the validation form, duly annotated and signed by the Agency Head, a copy shall be sent to the Division of Federal-State Relations (DFSR)/ORA.

OBJECTIVES

The basic objective of the FDA State Commissioning Program is to make inter-agency cooperation and coordination more effective. The program (1) permits commissioned state and local officials to operate under the Act which, in some situations, may afford enhanced consumer protection authorities; (2) enables senior state and local officials to review FDA non-public records without triggering provisions of the Federal Freedom of Information Act; (3) enables state officials to perform inspections and collect samples under contract to FDA even if their own laws do not give them the required authority; and (4) permits FDA investigators to perform certain state functions under controlled circumstances.

The advice and recommendations of senior state and local officials holding FDA commissions may be solicited on sensitive matters which can not otherwise be disclosed outside the Agency. Such consultation may take place on the regional and the national levels.

Headquarter/Center offices should notify respective Regional offices when the services of a commissioned official is requested and, when possible, the nature of the assignment. When the service is completed, a follow-up call should be made to the Regional office informing them of the result of the contribution of the commissioned official.

ELIGIBILITY REQUIREMENTS

All Agency Heads of state regulatory agencies appointed by the governor of the state are deemed to be qualified and eligible.

All Agency Heads of state regulatory agencies not appointed directly by the governor, and Agency Heads of local agencies shall be deemed to be eligible provided the individual's educational achievements, subsequent training, and career experience lend credence to the presumption that they are qualified in the area(s) in which they will be commissioned.

Program directors and subordinate officials must be qualified in the area or areas in which the commission is to be offered. This determination is made by the RFDD, based on a number of factors including: (1) the recommendation of the Agency Head of the agency in which the individual works, (2) the training and experience of the candidate, and (3) reports of Consumer Safety Officers and State Program Specialists who have worked with the candidate. If pertinent information on the candidate is incomplete or not readily available, the RFDD has the option of requesting a curriculum vitae (CV) from the candidate that covers the information (see Exhibit 3-1 for examples of questions usually answered by information recorded on a CV).

Program directors and subordinate officials in an agency can not hold a commission unless the Agency Head holds a commission or has indicated that he or she will accept a commission.

Notwithstanding the paragraph above, a person who is deputy to the Agency Head may be nominated by the Agency Head to be commissioned in place of the Agency Head to satisfy the requirement that the head of an agency must be commissioned if members of that agency hold commissions.

All state and local officials other than Agency Heads must be recommended for commissioning by their Agency Head.

No state or local official may be commissioned if he or she is determined to have a conflict of interest. A conflict of interest is where the official, his/her spouse, or his/her minor child(ren) have a financial interest in a firm that is operating in one of the specific fields where authority would be granted to the official as a commissioned official. In addition, if the official has a business relationship (e.g. contract) with the subject firm, that would also constitute a conflict of interest.

Commissioned officers must be citizens of the United States.

Final decision on eligibility for a commission rests with the RFDD

LEGAL RESTRICTIONS AND CONFLICT OF INTEREST SAFEGUARDS

The commissioned state or local official is considered to be an officer of the Department of Health and Human Services. However, accepting a commission does not subject the commissioned officer to the restrictions on political activity set forth in the Hatch Act, except on days in which the service under the commission is actually rendered.

The United States is liable for torts of its employees under the Federal Tort Claims Act as further clarified by the Federal Employees Liability Reform and Tort Compensation Act of 1988. The definition of employee includes persons acting on behalf of a federal agency in an official capacity, temporarily or permanently in the service of the United States, with or without compensation. This definition would include all individuals commissioned under this Program. However, the Federal Tort Claims Act would only apply if the individual holding a commission is performing federal duties.

Commissioned officials are subject to conflict of interest safeguards similar to those found in 21 CFR 20.89(c), which require the official to sign a written commitment to protect the confidentiality of information and to provide a written assurance that he/she has no financial interest in the regulated industry of the type that would preclude participation in the review of FDA assignment if the individual were subject to the conflict of interest rules applicable to the Food and Drug Administration advisory committee members under 21 CFR14.80(b)(1).

CONDITION TO HOLDING A COMMISSION

As a condition to holding a FDA commission, a state or local government official must provide a written assurance by signing the "Acceptance of Commission" (see Exhibit 3-7) that addresses the three safeguards below:

1. Confidentiality of Information. The official understands that any trade secret information the he/she reviews is entitled to significant and heightened protection under Federal law. The official further understand that if he/she makes any unauthorized disclosures of trade secret or confidential commercial information he/she will be committing a criminal violation under Federal Law (21 U.S.C. 331(j) and 18 U.S.C. 1905).
2. Financial Interest. The official (including spouse and minor children) does not have any personal financial interests (stocks, bonds, etc.), or any other financial or business relationships (contracts, consultant fees, etc.) in firms operating in the specific fields where authority will be conferred on the official as a commissioned officer.
Personal financial interest include the official's personal interest as well as the interests of a spouse and minor child(ren). It includes but in not limited to the following examples:
• The official owns or co-owns a firm;
• Spouse or minor child holds stock in a firm;
• The official works as a consultant or a contractor to a firm; or
• The official is employed by the firm.
3. Use of information for Personal Gain. The official agrees not to use information to further his/her private financial interests or the private financial interests of any individual.

POLICY NOT TO COMMISSION

As stated in RPM page 47, "Eligibility Requirements", FDA will not commission a state or local government official if he/she is determined to have a conflict of interest.

PROCEDURE REGARDING CONFLICT OF INTEREST SAFEGUARDS PRIOR TO COMMISSIONING

An individual recommended for a commission may discuss questions about the Conflict of Interest Safeguards with his/her sponsoring FDA official.

In the event that the candidate becomes aware of a potential financial interest that would affect the individual's participation under the FDA Commissioned Program, the sponsoring FDA official will summarize the issues and submit it along with other documentation to the FDA Regional office for resolution. All issues affecting candidate's financial interests must be resolved prior to granting a commission.

POLICY AND PROCEDURE DURING TIME OF COMMISSIONING

Policy. The FDA commissioned official must remain free from financial interests which may affect the specified authorities in the FDA commission.

Procedure. In the event that a financial interest is acquired after the official receives a commission, he/she must notify FDA and must not participate in any assignment affected by the financial interest.

The Sponsoring FDA official will summarize the issues and submit it along with other documentation to the FDA Regional office for resolution.

The resolution may range from disqualification from participating in any commissioned authorities pertaining to the firm, to revocation of the commission and return of the FDA credentials. However, if the financial interest is removed, FDA would again consider the official for commissioning.

PRIVACY ACT

The Privacy Act of 1974 has an impact on cooperating officials because (1) the candidate for a commission may be asked to supply personal information; (2) the candidate may possibly receive a background check; and (3) a personnel file on the commissioned officer is maintained by DFSR.

APPLICATION FOR COMMISSION

In the event that an RFDD needs further information on which to make a determination of the qualification of the candidate, the RFDD may require a completed curriculum vitae covering standard questions usually answered by applicants for employment (Exhibit 3-1).

BACKGROUND CHECK

Under normal circumstances, no background checks will be made of officials employed by state and local regulatory agencies. However, the Agency retains its right to make such a check.

A candidate for a commission should be informed of the above statement.

In the unusual event that a proposed candidate for a commission has not had a background check by his or her own agency, the RFDD may decide (a) not to offer a commission, (b) offer a commission on the basis of other information on the candidate, or (c) require a background check.

If a state or local official has received a commission and substantive questions subsequently arise, the RFDD has the option of (1) revoking the commission, (2) determining through other means whether or not a problem really exists, or (3) requiring a background check.

If the candidate or commission holder has not completed a curriculum vitae, one should be requested from the individual. Failure of that individual to supply a curriculum vitae to the RFDD upon request may be considered grounds for withdrawing the offer of a commission, or revoking a previously issued commission.

In the event that an RFDD determines that a background check should be made, the RFDD has the option of issuing the commission prior to receiving the results of the check, or waiting until the background check has been made.

If the RFDD requires a background check, a package of all information gathered on the candidate, including any curriculum vitae furnished by the candidate, shall be sent to DFSR who will obtain the background check through the Office of the Inspector General of the Department.

Obtaining an FDA commission is a privilege extended to a select and limited number of regulatory officials. In the event that the information on a person is such that it is deemed prudent to require a background check, members of the regulatory profession should understand and take no umbrage. In the event, however, that a candidate objects to the process, or challenges the right to make such a check, that individual is considered to have withdrawn his or her candidacy and the background check will not be made.

MAINTENANCE OF FILES

Files maintained on commissioned officers are subject to the Privacy Act.

A commissioned officer wishing to review his or her own file may obtain a copy by asking the RFDD.

All other questions about this file should be addressed to the FDA Freedom of Information Staff (HFI-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

THE COMMISSIONING PROCESS

REASONS FOR COMMISSIONING

Commissions should be offered if it is deemed by the RFDD that such an action is in the interests of the Agency. There are no hard and fast guidelines for making such a determination. However, there are some reasons which may apply to specific cases:

1. The individual is by position, training, and/or experience a person whose advice and counsel on confidential or sensitive matters is desired on the district, regional, or national level.
2. The individual is, by position, a person who would have to review the recommendations of a commissioned subordinate in order to assure FDA that the recommendations represent the official views of the state or local agency. Since only holders of FDA commissions can review certain FDA documents, it would be necessary that the supervisory individual be commissioned.
3. The individual is engaged in joint state-FDA investigatory operations.
4. The individual is engaged in carrying out a contract issued by FDA for which the application of federal law is required for successful completion of the contract.
5. It is necessary to have access to FDA information of an investigatory or otherwise confidential nature.
6. The state or local official is helping FDA in a special manner for which FDA credentials are required. For example, an FDA district may require samples to be collected on a routine basis from a plant that is located about a half-day's journey from the closest FDA post. However, a state employee, located near the plant, could, if commissioned, pick up the samples at a tremendous savings in time and money to FDA (it is assumed that FDA would make arrangements for this with the state agency that are satisfactory to that agency).

INITIATING THE PROCESS

When the need to commission a state or local official is discerned, a written recommendation to that effect should be sent to the RFDD through a district director or director of state programs. This recommendation should specify:

1. the full name, title, and agency of the individual for whom the commission is being requested
2. the reasons for which the commission is requested
3. the program area or areas for which the commission will be issued (see RPM page 45, "General Provisions - Program Areas").
4. which of the four activities the individual will be authorized to perform (see RPM page 45, "General Provisions - Activities").
5. whether the individual is to be issued a certificate, pocket credentials, or both (see RPM page 45, "General Provisions - Certificates and Credentials").

A line should be typed on the memorandum on which the RFDD can indicate his concurrence or non-concurrence.

CONTACTING THE CANDIDATE

All state and local officials who have been nominated for an FDA commission must be contacted before a commission is prepared to be sure the individual understands the terms and conditions attached to holding a commission and that the person will accept the commission when presented. Specific points to cover include:

1. general description of the commissioning program
2. purpose for which this particular commission is offered
3. what will and won't be expected of the candidate
4. conflict of interest safeguards and what they mean
5. the need for the candidate to be an American citizen
6. the possibility that a background check might be required at some time in the future
7. appreciation of the Individual's willingness to serve.

At the conclusion of this discussion it must be clear that the individual sees no obstacle to holding a commission and will accept the commission when it is formally offered.

Should a question arise regarding a possible conflict of interest that can not be resolved by the sponsoring FDA official, the sponsoring FDA official will summarize the issues and submit it along with other documentation to the FDA Regional office for resolution. The matter will then be discussed with the RFDD and a decision reached as to whether or not the individual can be commissioned.

In the case of an Agency Head, this discussion should be conducted in person by the RFDD. If circumstances make this impractical, a visit for this purpose may be made by a district director, director of state programs, or assistant regional director for intergovernmental affairs. Agency Heads who are already familiar with the program and for whom this information need not be duplicated may be contacted by telephone to get the assurance that the commission, when offered, will be accepted.

In the case of a program director and/or a subordinate officer, this discussion should be conducted by a district director, assistant regional director for intergovernmental affairs, or the director of state programs. However, in situations where the commissioning program is ongoing and well understood by the program director, the discussion may be held with a supervisory investigator with whom the program director already works. Since it is not always practical to meet with each subordinate, the program director may vouch for his or her subordinate.

If there is reasonable assurance that the candidate(s) for commissioning are eligible and will accept the commission(s) then, to speed the commissioning process, the "commissioning packets" discussed in the next section may be prepared in advance and brought to the meeting. The FDA official may remain and be available to answer questions while the forms in the commission package that have to be returned to FDA are filled out and handed back.

If it is determined that the candidate for commissioning is not eligible, a letter must be issued to the candidate and his/her supervisor informing them of the reasons for the withdrawal of the offer of a commission.

THE "COMMISSIONING PACKAGE"

Upon confirmation to the RFDD that a commission will be accepted, a "commissioning package" shall be delivered to each candidate. This package contains:

1. A letter signed by the RFDD offering the candidate a commission.
a. In the case of an Agency Head, the letter will cite the Commissioner's desire that the candidate have an FDA commission (see Exhibit 3-10).
b. In the case of a program director or an individual subordinate to the program director, the letter will go to the Agency Head but omit mention of the Commissioner (see Exhibit 3-11).
2. A copy of the brochure The FDA Commission. Previous editions of this publication are obsolete. 3. Acceptance of Commission form (see Exhibit 3-7).
3. One blank Identification Card (see Exhibit 3-2).
4. (only at RFDD's specific instructions) A request for a curriculum vitae (see Exhibit 3-1).
5. Basic Information From Candidate form to be filled out and signed (see Exhibit 3-12). Asks candidate to supply: full name; aliases; home address; title; agency; division or dept.; address; date of birth; place of birth; social security number; data for pocket credentials; and affirmation of American citizenship.
6. Instructions to Candidate form (see Exhibit 3-13). Explains what to do with the identification card, size and number of pictures required, and need for copy of naturalization papers if not born in the U.S.

Upon receipt of those portions of the commissioning package that have been requested to be returned to the RFDD, the material is checked for accuracy and completeness. Forms which have been only partially completed or completed incorrectly will be returned to the candidate with a request for correction(s).

THE COMMISSION DOCUMENTS

After the information from the candidate has been checked, the following materials are prepared and sent to the newly commissioned officer:

1. A letter, signed by the RFDD, thanking the individual for accepting a commission.
2. f appropriate, laminated pocket credentials in a credential case (see Exhibits 3-2 and 3-3).
3. A Certificate of Commission, either signed by the Commissioner or signed with a facsimile signature (see Exhibit 3-4). A small stock of Certificates of Commission pre-signed by the Commissioner and/or the facsimile stamp for the Commissioner's signature shall be kept in the RFDD's safe.
4. A form to be returned to the RFDD on which the Commissioned officer can order certain FDA material without charge (see RPM page 51, "Relationship with Commissioned Officers - # 5" and Exhibit 3-14).

RELATIONSHIP WITH COMMISSIONED OFFICERS

FDA's relationship with state and local agencies is very important as our mission will require closer coordination and better cooperation to provide the level of consumer protection demanded by our citizens. Having state and local officials hold FDA commissions should help promote our efforts to foster better understanding of FDA's mission and how we carry out our functions.

Having an FDA commission is, for most holders, both a tangible and intangible benefit. Not only can the commission help the holder get his or her job done but it can be viewed as a recognition by FDA of the individual's competence, experience, and training. A program manager whose subordinates are selected to hold FDA commissions may consider that the commissions validate the superior training and competence of the group that he or she manages. We need to encourage the recognition that an FDA commission is a thing of value, reflecting well on the holder.

To encourage closer ties with cooperating state officials who hold FDA commissions, to inform them about FDA, and to let our Agency benefit from their knowledge and experience, the following steps should be considered by the RFDD:

1. 1. Regional Meetings. The RFDD should plan and hold a yearly one-day meeting for all commissioned Agency Heads. This event could include a discussion on FDA priority decisions, presentations by senior agency officials on new developments, policy matters, state contracts, and training. Much of the meeting would be spent in soliciting their views and suggestions. Examples of effective state-federal cooperation would be cited; individuals who had done well in joint projects would be recognized.
Should such a meeting prove impractical due to travel restrictions on out-of-state Agency Heads, or lack of funds to underwrite travel by the state officials, the RFDD might substitute visits to the office of each commissioned Agency Head. Alternatively, commissioned Agency Heads can be invited to a closer FDA facility for the meeting. The discussion might cover matters similar to those suggested in the preceding paragraph.
2. Recognition from the Commissioner. The RFDD may prepare a letter for the Commissioner's signature recognizing outstanding efforts by a state or local commissioned individual, his or her unit, division, or agency. Such letters should be sent via DFSR for signing and mailing. . Awards. The RFDD may nominate commissioned individuals, or groups of commissioned individuals for FDA awards, medals, or commendations similar to those awarded to FDA employees.
3. Binders. Each commissioned officer should be given a binder or binders appropriate to the FDA material they are to receive and maintain.
4. Literature and Publications. At the option of the RFDD, commissioned officers, especially agency heads, should be offered, without cost, subscriptions to selected FDA publications and reports. It is important that they only receive those publications which they want and which meet their particular needs. Their wishes in this respect can be communicated to FDA by use of a Request For FDA Materials form (Exhibit 3-14). Examples of the wide range of publications which could be offered are:
a. FDA Investigations Operation Manual
b. FDA Compliance Policy Guides Manual
c. FDA Consumer (monthly)
d. FDA Today (quarterly)
e. Catalog of Courses and Training Materials (ORA)
f. National Training Course Catalog (ORA)
g. The CDRH Newsletter (or similar newsletters from other centers and the Office of Regulatory Affairs)
h. Weekly Federal Register summary
i. Monthly Drug and Device Product Approval List
j. Annual Directory of State Officials
k. Laboratory Information Bulletin (LIB)
l. Approved Drug Products With Therapeutic Equivalence Evaluations (and cumulative supplements)
m. FDA Quarterly Activities Report
n. Special reports in the area in which the commission is held
5. Training. In addition to receiving headquarter initiated training bulletins, the RFDD will make sure that any training course sponsored or held within his or her region is announced to all officers commissioned in the area for which the course is intended. They will be given priority over non-FDA personnel to attend should they indicate they wish to.
6. State Activity Information Letter (SAIL). Commissioned program directors should be contacted once a month to get input for SAIL. Help in putting together the material should be offered.
7. Visibility. Commissioned state and local officials should be considered when disseminating information to the public about FDA activities. For example, Consumer Affairs Officers who have radio or television programs, or who write columns for newspapers or magazines, should report interesting and meaningful activities of commissioned officers. Regional and district officials compiling material for FDA Consumer should also include stories concerning the activities of commissioned officers.
8. District Meetings. Commissioned officers should be invited to all or part of annual district meetings.
9. Laboratory Support. Commissioned officers should be shown particular consideration in extending laboratory support to run state samples or permit state personnel to use laboratory facilities.
10. Biennial Evaluation. Every two years, commissioned officers will be asked for their evaluation of the Commissioning Program (see Exhibit 3-15 for the evaluation form). The completed evaluation will be incorporated into the field report to DFSR, see RPM page 54, "DFSR Program Responsibilities".

ACCEPTANCE OF STATE COMMISSIONS

Occasionally, it becomes useful for an FDA investigator to exercise state powers. This can be true because a state official is not available at the time and place required, or the state has powers, such as the ability to place an embargo, not held by FDA.

An FDA Consumer Safety Officer may hold a state commission provided:

1. The commission is offered by a state agency whose Agency Head holds an FDA commission; and
2. No use whatsoever of the commission is made unless and until a state official, authorized by the state regulatory agency, has given prior permission to use the state commission in each specific contemplated use. Concurrently, the supervisor of the FDA investigator must be informed of the contemplated use of the commission and concur.

RECORD KEEPING

Each regional office shall establish and maintain individual records on each commission issued within the region. This record shall include:

1. number, date issued, and expiration date of credential issued. This information, along with other data, may be entered on (optional) Form FDH 2081 (Exhibit 3-6)
2. data on commission holder contained on the Basic Information From Candidate For An FDA Commission form
3. copy of naturalization papers if the officer was not born in the United States.
4. andidate's curriculum vitae, if the RFDD specifically requested that one be furnished
5. signed Acceptance of Commission form
6. all correspondence including awards
7. photocopies of credential forms (FDA 1990a and FDA 200A)
8. one color photograph of commission holder

Each regional office shall maintain a record of the annual validation of all credentials issued in the region (Exhibit 3-9). Copies of the validation forms shall be sent to DFSR.

At the conclusion of the issuance of a commission, the complete file shall be photocopied (except that one of the three photographs obtained from the commission holder shall be used instead of a photocopy) and a duplicate file folder made. This duplicate record shall be sent to DFSR. DFSR will maintain the national roster and official nationwide file of commissioned officers.

The regional office shall notify each district director of the issuance of the commission.

RENEWAL OF COMMISSIONS

Approximately two months before the expiration of the three-year period for which a commission is valid, a review of the commissioned officer's record shall be made. This review shall consider all pertinent aspects of the use made of the commission including inspections made, samples collected, advice and consultation extended, and cooperation offered in both routine and emergency situations.

A memorandum shall be prepared to the RFDD making a recommendation whether or not to renew the commission. This recommendation may be signed by a district director, director of state programs, regional executive officer, assistant regional director, or other official formally charged with oversight of the commissioning program. The RFDD shall indicate whether he or she concurs or not with the recommendation. A copy of this document shall be sent to DFSR.

If the RFDD has agreed to a renewal, a new Form FDA 1990a and Form FDA 200A shall be prepared and exchanged for the ones about to expire. This exchange may be handled in any convenient way, provided the old Form FDA 1990a and Form FDA 200A are returned to the RFDD for cancellation.

The commissioned officer is to be sent a new Acceptance of Commission form (Exhibit 3-7) to be completed and sent back to the Regional office.

NON-RENEWAL OF COMMISSION

A commission which otherwise would be renewed may not be renewed if the individual who holds it has changed positions, resigned, or retired. A decision not to renew a commission may be made at any time if the conditions so warrant. If the commission is not to be renewed, a letter to that effect should be sent to the supervisor of the individual. This letter should briefly cite the reason. Examples of reasons include: "change of position", "resigned", "retired", "no longer involved in FDA contract work", "inactive", or "at holder's request."

Commissions for which only a certificate was issued may be allowed to expire without correspondence indicating that the commission will not be renewed. Instead, a letter thanking the commission holder for their service shall be sent. A copy of this letter shall be sent to DFSR.

As soon as a decision is made that a commission will not be renewed, arrangements must be made to collect the pocket credentials. These credentials shall be cancelled by cutting in two and placing in the regional file holding the records of that commission.

DFSR should be immediately notified of a non-renewal of commission so that the subscriptions and routine mailings of information to that person can be stopped, and the file on that commission be closed.

Commission non-renewals are made without prejudice. That is, there is no implication that the commissioned officer might not be recommissioned at some later date should conditions change.

REVOCATION OF COMMISSION

Commissions may be revoked for cause. A reason for revocation could be the abuse or misuse of the commission, including transmittal of confidential information to individuals who are not employees of the Department of Health and Human Services. Other appropriate causes for revocation include conflict of interest, arrest and conviction for a felony, substance abuse, and behavior which may bring discredit on the agency.

A memorandum recommending such an action and detailing the reasons therefore may be sent to the RFDD by a district director, assistant regional director, executive officer, director of state programs, or other officer specifically charged with oversight of the commissioning program.

If the RFDD concurs, a letter signed by the RFDD shall be sent to the Agency Head stating the details of the revocation and requesting that the certificate of commission, pocket credentials, and any documents belonging to FDA be collected and returned to the RFDD by registered mail. A copy of this letter shall be sent to DFSR so that the subscriptions and routine mailings of information to that person can be stopped and the file on that commission closed.

Revocation of a commission is done with prejudice. That is, the individual concerned is no longer eligible for an FDA commission.

LOST CREDENTIALS

Pocket credentials may not be retained by commissioned officers as mementos or souvenirs. The Certificate of Commission may serve this purpose. This information should be made clear to each commissioned officer who holds pocket credentials.

Loss of credentials is considered serious. Commissioned officers should be asked to report the loss of their pocket credentials immediately to the RFDD or designated official. Information on the loss of the credentials should be sent to DFSR for transmittal to the Federal Bureau of Investigation.

DFSR PROGRAM RESPONSIBILITIES

Maintaining a current national inventory of state officials holding commissions issued by the Regional Food and Drug Directors.

Arranging for initiation, when requested by a Regional Food and Drug Director, special checks of a candidate for an FDA commission, when the field manager has determined such eligibility review is necessary.

Notifying the Office of Facilities and Administrative Management, Division of Administrative Management, Physical Security Staff of lost state commissioned official's credentials, and of commissions that have been revoked for cause upon the recommendation of a Regional Food and Drug Director and concurrence of the Associate Commissioner for Regulatory Affairs.

Preparing a biennial report by January 31 on the status of the commissioning program, field utilization of this cooperative program and significant achievements of the program. The national summary report will be based on data reported by the regions.

EXHIBITS

3-1 Examples of personal information that would be expected to be found on a curriculum vitae

3-2 Form FDA 200A, Pocket Credential Identification Card

3-3 Form FDA 1990a, Pocket Credential Authority Card

3-4 Form FDH 2088, Certificate of Commission

3-5 Letter transmitting confidential information (sample)

3-6 Form FDH 2081, Commissioned Officer's Record (optional)

3-7 Form, Acceptance of Commission

3-8 Annual Letter Requesting Validation of Credentials (sample)

3-9 Form, Accounting for FDA Credentials for Calendar Year

3-10 Letter Offering a Commission to an Agency Head (sample)

3-11 Letter Offering a Commission to non-Agency Heads (sample)

3-12 Form, Basic Information From Candidate

3-13 Form, Instructions to Candidate

3-14 Form, Request for FDA Materials

3-15 Letter Requesting Commissioned Official to Evaluate Program (Biennial)

------------------------

SUBCHAPTER

WORK-SHARING AGREEMENT GUIDANCE

PURPOSE

This subchapter sets forth the authority, policy,

format, and responsibilities for the establishment of work-sharing agreements with state and local agencies.

Interagency Agreements (IAGs) and Memoranda of Understanding (MOU's) between FDA and other federal agencies and foreign governments are covered under Staff Manual Guide (SMG) 2820.1.

AUTHORITY FOR FEDERAL STATE COOPERATION

The Federal Food, Drug, and Cosmetic Act, Section 702(a), authorizes the Secretary to commission state and local officials to conduct examinations and investigations for purposes arising under the Act. Section 311(a) of the Public Health Service Act states that the Secretary "shall cooperate with and aid state and local authorities in the enforcement of their quarantine and other health regulations ..." Broad authority for intergovernmental cooperation in the conduct of specialized or technical services is provided under Title III of the Intergovernmental Cooperation Act of 1968 (PL 90-577).

POLICY

It is the policy of the Food and Drug Administration to initiate and enter into cooperative work-sharing programs with agencies of state or local governments whenever such cooperation creates a partnership which ensures overall consumer protection and effectively utilizes the expenditure of resources. It is also FDA's policy that cooperative work-sharing agreements should be formalized by a Memorandum of Understanding, signed by the participating parties.

OTHER ALTERNATIVES

Where a work-sharing agreement between FDA and a state authority is not in effect FDA should promote cooperation between state and federal authorities to the extent possible. To this end FDA regional management can use an "Exchange of Correspondence," which is essentially an exchange of letters/memoranda in which each agency (FDA and state or local) sets forth, separately, those selective program areas where a cooperative work-sharing effort is appropriate.

There are a number of unwritten working arrangements between districts and state or local government agencies. FDA should routinely evaluate whether these arrangement should be the subject of an MOU or an Exchange of Correspondence.

SUBJECT OF AGREEMENT

The subject matter to be included under a formal program will obviously vary. The only relevant criterion is that the subject matter be within the regulatory jurisdiction of the parties. It is axiomatic that neither FDA nor a state or local agency can abdicate its legal responsibilities under such an agreement. Consequently, it is customary for an agreement to provide that the parties retain independent responsibility over some aspect of the work covered by a formal agreement.

The parties to an agreement must decide how the work will be apportioned. For example, under an agreement one party might agree to collect product samples for analysis by the other party.

RESOURCE COMMITMENTS

Because both parties must be able to contribute a portion of the resources necessary to accomplish the terms of the agreement, each party must be aware, when the agreement is entered into, of the expenditure of resources likely to be required.

PRIORITIES

The projected resource allocations will indicate the priorities of each party. Nevertheless, the parties, prior to entering into an agreement must discuss not only the divisions of labor being agreed to, but the priorities each party will assign to each designated task. To this end, parties, prior to entering an agreement, should thoroughly discuss their respective regulatory and compliance philosophies.

AUTHORITY FOR SIGNING

The agreement may be signed for FDA by either the Regional or District Food and Drug Director, at the option of the Regional Food and Drug Director.

AGREEMENT FORMAT AND CONTENT

FORMAT (ATTACHMENT A)

To insure that there is a relatively uniform national approach in the development and implementation of these agreements, a basic format should be used. A guideline format, Attachment A, has been developed for this purpose.

CONTENT

The guideline further offers some "boilerplate" language which may be used in developing the terms of agreement. The areas of agreement to be considered are not limited to those major elements listed in Attachment A - III - Substance of Agreement. However, the suggested "boilerplate" options listed in Attachment A have been approved by General Counsel and the Associate Commissioner for Regulatory Affairs. Any significant variation from the pre-approved "boilerplate" language for the agency commitments in the agreement, especially those involving FDA policy or enforcement of statutes(s) require review and approval by headquarters before execution (signing).

QUALITY ASSURANCE (MUTUAL)

A work-sharing agreement should provide that a quality assurance evaluation may be performed at the request of either party to ensure that the agreement is being carried out efficiently and effectively in the interest of each party. To this end, the parties should meet periodically (annually or semi-annually) to conduct such an evaluation. See Exhibit 3-16, Attachment A - Joint Planning, Option a or b. While no formal reporting format is required, the method of exchange (e.g., by memorandum, discussion during program review and planning conference(s), etc.), should be agreed to by the participants and should be specified in the agreement.

REPORTING REQUIREMENTS

SPONSOR

Two (2) originals for FDA, plus state needs as determined. On signature, the sponsor will submit a signed original under cover memorandum to the Office of Regional Operations, Division of Federal-State Relations, HFC-150. One original signed copy of the MOU will be maintained in the regional office. Any subsequent modification or renewal to the agreement should be documented and an original signed copy forwarded to DFSR, see Exhibit 3-17, Attachment B - Addendum (sample).

OFFICIAL REPOSITORY

The Division of Contracts and Grants Management, Office of Administration, State Contracts and Assistance Agreements Branch (HFA-520) is designated as the official repository for these agreements. DCGM/SCAAB will maintain a current listings of all MOU's and agreements. One original, plus one copy will be transmitted by DFSR to DCGM/SCAAB. The signed original will be the official repository copy. A WordPerfect 5.1 file will be sent to DFSR.

DCGM/SCAAB will assign a control I.D. number (prefix 225) to the agreement and return the copy document to DFSR with the assigned control number denoting the official repository's receipt of the agreement document.

COMPLIANCE POLICY GUIDES (CPG) INDEXING

DFSR will provide a copy of a new agreement or an addendum, when there is a substantive modification to an existing agreement, to the Division of Compliance Policy (HFC-230), for the purpose of formatting and filing in the agency's CPG - Chapter 57 - Memoranda of Understanding and Agreements with State Agencies.

EXHIBITS

3-16 Attachment A - Guideline Format

3-17 Attachment B - Addendum

Exhibit 3-1

SAMPLE QUESTIONS ANSWERED ON A CURRICULUM VITAE

The following questions are the ones for which answers are usually found on a routine curriculum vitae (CV) prepared by an individual seeking employment. However, few, if any, CVs would answer all the questions on this check-list.

1. Title (Mr., Mrs., Ms, Dr.)
2. Name (first, middle, last)
3. Social Security number
4. Home address (apartment no., street, city, state, Zip)
5. Home telephone number (including area code)
6. Office telephone number (including area code)
7. Date of birth
8. Place of birth (city, state or other country)
9. Citizenship
10. Marital status (married, widowed, divorced, single, separated)
11. High school (name, location, and date of graduation)
12. Colleges attended (names, locations, and dates)
13. Major field(s) of study at highest level of college work
4. Degrees confirmed (dates)
15. Honors, awards, fellowships, or scholarships received in schools
16. Honors and recognitions received in professional life
17. Employment history. Starting with current position and working backwards,
 preferably to completion of education, give: name and address  
of employer, title of position held, name and telephone number of immediate supervisor
18. Three references (other than current employer or family - include their addresses
 and telephone numbers)
19. Licenses or certificates held (cite type and issuing agency)
20. Military or civilian federal service (branch, department, agency, rank or
 rating at separation, date of separation)

Exhibits 3-2 & 3

FORM FDA 200A: IDENTIFICATION CARD

and

FORM FDA 1990A: AUTHORITY CARD

Exhibit 3-4

FORM FDA 2088: CERTIFICATE OF COMMISSION

Exhibit 3-5

LETTER TRANSMITTING CONFIDENTIAL INFORMATION (SAMPLE)

(Regional letterhead)

FOR OFFICIAL USE ONLY

State Health Commissioner
State/Local Agency
123 Elms Street
Somewhere, US 00000

Date

Dear Commissioner:

I am enclosing the following confidential document:

Revised Policy for Dealing with Salmonella Enteritidis in
Chickens, Draft dated January 18, 1989

Your input on this matter is very much desired. I'd appreciate it if you would
review this draft and give me your comments as soon as possible, but not later
than February 28, 1989.

Permit me to remind you that this material is identified as being for official use
only, and is so marked. As an FDA commissioned officer, you must maintain the
confidentiality of this material unless and until FDA determines that the information 
may be released to the public. 

You may share this material only with members of your staff who hold FDA
commissions specifying that they can receive and review official FDA documents.
Divulging this material to others is not permitted.

hank you again for all your assistance.

   Sincerely,

   Regional FDA Director

Enclosure: a/s

FOR OFFICIAL USE ONLY

Exhibit 3-6

FORM FDH 2081: COMMISSIONED OFFICER'S RECORD (OPTIONAL)

Exhibit 3-7

FORM: ACCEPTANCE OF COMMISSION

(Regional letterhead)

ACCEPTANCE OF COMMISSION

In accepting a commission as an officer of the Department of Health and Human Services as authorized by law, I have read and understand the provisions of 21 U.S.C. 331(j) [Section 301(j) of the Federal Food, Drug, and Cosmetic Act] which contain this specific prohibition:

"The using by any person to his own advantage, or revealing, other than to the Secretary or officer or employees of the Department, or to the courts when relevant in any judicial proceeding under this Act, any information acquired under authority of section 404, 409, 412, 505, 507, 510, 512, 513, 514, 515, 516, 518, 519, 520, 704, 721, or 708 concerning any method or process which as a trade secret is entitled to protection."

Section 520(c) of the Federal Food, Drug, and Cosmetic Act also prohibits the release of information exempt from disclosure pursuant to 5 U.S.C. 552(b)(4) of the Freedom of Information Act that is obtained under section 513, 514, 515, 516, 518, 519, 704, or under 520(f) or 520(g) of the FD& C Act.

I understand that any trade secret and commercial confidential information that I review is entitled to significant and heightened protection under Federal law. I further understand that if I make any unauthorized disclosures of trade secret or confidential commercial information I will be committing a criminal violation under Federal Law (21 U.S.C 331(j); 18 U.S.C. 1905).

I shall not use this information to further my private interests or the interests of any other person.

I attest that I (including my spouse and minor children) do not have any personal financial interests (stocks, bonds, etc.), or have no financial or business relationships in firms operating in the specific fields where authority has been conferred on me as a commissioned officer.

____________________________________ _____________________________
signaturedate

Certification of the Recommending Agency Head

I certify that, to the best of my knowledge, this candidate for an FDA Commission is an individual of good character, ability, and work habits and is capable of carrying out the responsibilities of a commissioned officer of the Department of Health and Human Services, Food and Drug Administration.

_______________________________________________Signature of Agency Head

Exhibit 3-8

ANNUAL VALIDATION LETTER (SAMPLE)

(Regional letterhead)

State Health Commissioner
State/Local Agency
123 Elms Street
Somewhere, US 00000

 Date

Dear Commissioner:

As you are aware, the FDA credentials held by members of your Department have a high potential for misuse, particularly if lost. Because of their importance, we are conducting a review to make sure that each credential exists and is held by the person to whom it was issued.

Enclosed is our form "Accounting for FDA Credentials for Calendar Year 19xx" listing each member of your Department holding pocket credentials and the numbers assigned to these credentials. We ask that you, or an official designated by you, make a personal examination of each credential, confirm that its number matches the number on our form, and then certify to FDA that the credential exists.

If anyone on the list is no longer an employee of your Agency, or will leave its employ before needing to use his or her pocket credentials, please indicate this on the form by crossing off his or her name. I'd also appreciate it if the credentials could be collected from the individual(s) and returned to me via registered letter.

If any credentials cannot be located, please advise me immediately.

Thank you for your assistance.

        Sincerely yours,

        Regional FDA Director

Enclosure: a/s

Exhibit 3-9

FORM: ANNUAL VALIDATION OF FDA CREDENTIALS

(Regional Letterhead)

Accounting for FDA Credentials for Calendar Year 19XX

Agency:

   Name           Credential Number

Validation Statement 

I have personally viewed all the FDA credentials listed above and confirm that these credentials issued to the individuals named above exist. Any exception to this statement is indicated below:

[ ] None, or:

Date:       ____________________________
 Signature

Name:          Title:

Exhibit 3-10

LETTER OFFERING A COMMISSION TO AN AGENCY HEAD (SAMPLE)

(Regional letterhead)

State Health Commissioner
State/Local Agency
123 Elms Street
Somewhere, US 00000

Date

Dear Commissioner:

It is my distinct pleasure to offer you a commission in the Department of Health and Human Services, Food and Drug Administration. Commissioner (NAME) recently made a particular point of his desire to have you serve with us.

The commission will enable you to receive and review official FDA documents. This will permit us to benefit from your review and recommendations on policy matters which are still confidential. We are anxious to get your input on current public health issues, not only as they affect your State, but the nation as a whole.

Reaching you with this letter is a packet of informational materials and some forms which need to be filled out so that we can finish processing your commission. In particular, please review the booklet, "The FDA Commission." If you have any questions whatsoever on this material, please give me a call.

Our agencies have a good record of working closely together to protect the citizens of (name of state). Your acceptance of this commission augurs well towards continuing our fruitful cooperation and coordination.

Best personal regards,

               Sincerely,

               Regional FDA Director

Enclosure: a/s

Exhibit 3-11

LETTER OFFERING COMMISSION TO NON-AGENCY HEADS (SAMPLE)

(Regional letterhead) State Health Commissioner

State/Local Agency
123 Elms Street
Somewhere, US 00000
Date

Dear Commissioner:

I am pleased to offer, with your concurrence, FDA commissions to the

following individuals on your staff:

NAME, AGENCY {for (name program areas)}

These commissions will authorize these individuals to conduct examinations, inspections, and investigations; collect and obtain samples; copy and verify records; and receive and review official FDA documents. They will have the same authority as do regular FDA officers within the limitations specified in their commissions. These individuals will, of course, continue to serve under your direction.

Enclosed with this letter are packets of informational material and forms for each candidate. Please note that your signature will be required on the "Acceptance of Commission" form and, if "Application for Commission" forms are included, in section 19 of that form. When these forms are completed, please ask the individuals return them to my office, attention: (name of FDA official).

We will be most happy to have these members of your staff join the ranks of FDA commissioned officers, and I personally appreciate your willingness to permit them to serve with us.

             Sincerely yours,

             Regional FDA Director

Enclosures: a/s

Exhibit 3-12

FORM: BASIC INFORMATION FROM CANDIDATE

(Regional letterhead)

BASIC INFORMATION FROM CANDIDATE FOR AN FDA COMMISSION

This information is necessary to process your commission. Please complete this form and return it to the FDA Regional Office. Accuracy is essential.

Last or Family Name:_____________________________________________
First or Given Name:_____________________________________________
Middle Name(s) or Initial(s)        _____________________________________________

(if you do not have a middle name or a middle initial, enter "not applicable")

Other names or aliases used:_____________________________________________________

Date of Birth:__________________________Place of Birth:__________________________

(If not born in the United States, please attach photocopy of naturalization papers or
 other document attesting to citizenship)

Social Security Number:        ____________________________________________
Home Address:  ____________________________________________
City, State, and Zip:          ____________________________________________
Job Title:     ____________________________________________
Agency:        ____________________________________________
Division or Dept.:             ____________________________________________
Address:       ____________________________________________
City, State, & Zip:            ____________________________________________
Data for pocket credentials:   ____________________________________________

Height:__________Weight:__________Color Eyes:_________
Color Hair: __________________

I affirm that I am an American citizen.

      Date: __________________

              ______________________________________
     (signature)

Exhibit 3-13

FORM: INSTRUCTIONS TO CANDIDATE

(Regional letterhead)

INSTRUCTIONS TO CANDIDATE FOR AN FDA COMMISSION

You have been offered a commission as an officer of the Department of Health and Human Services, U.S. Food and Drug Administration. Congratulations! However, before the actual commission can be conferred, some processing is necessary. This information sheet is designed to help you with the paperwork.

o The FDA Commission (brochure). This booklet contains information about the FDA commission that you need to know. Please read this material carefully and retain for future reference.

o Acceptance of Commission. This must be signed by you. If you have questions about possible conflict of interest please talk to your FDA advisor. Note that this form requires a certification signed by the head of your agency. Please obtain this signature and return the form.

o Basic Information. This form asks some basic information needed to complete processing of your commission. Please answer each question, sign, and return.

o Identification Card. If you are to be issued pocket credentials, we need your signature on this card. Please sign in black ink. Do not fill in any other part of the card; this will be done later. Return this card.

o Application for Commission. This form asks you for data which needs to be reviewed prior to issuance of a commission. Note that item 19 requires a certification signed by the head of your agency. If the information on this form has been obtained elsewhere, this form has been omitted from the package.

o Photographs. We need three color pictures of your face. The pictures will be trimmed to 1 3/8" high X 1 1/2" wide. In addition--and this is optional--we would appreciate a black and white photograph of you that could be used for promotional purposes.

Should you have any questions about this material, please contact your FDA advisor.

Exhibit 3-14

FORM: REQUEST FOR FDA MATERIALS

(Regional letterhead)

REQUEST FOR FDA SUBSCRIPTIONS, LITERATURE, AND MANUALS

As an FDA commissioned officer, I would appreciate receiving the following materials. I understand that manuals and some directories require frequent updating. Please sent the material marked "H" to my residence, and the material marked "O" to my office.

Name: ________________________________Title:_______________________________

Office Address          Home Address

Dept.:____________________________           Apt. #:_____________________________

Street: __________________________           Street:_______________________________

City:_____________________________           City: ________________________________

State & Zip:______________________           State & Zip:__________________________

(mark an "H" or an "O" within the brackets next to the material you want)

[ ] FDA Investigations Operation Manual

[ ] FDA Compliance Policy Guides Manual
[ ] FDA Consumer (monthly)
[ ] Drug and Device Approval List (monthly)
[ ] FDA Today (quarterly)
[ ] FDA Activities Report (quarterly)
[ ] Newsletter or bulletin from ____________________________________
      (Cite center, division, or unit; if not sure, specify area of interest.)
[ ] Catalog of Courses & Training Materials (ORA) 
[ ] National Training Course Catalog (ORA) 
[ ] Approved Drug Products With Therapeutic Equivalence Evaluations 
[ ] Laboratory Information Bulletin (LIB) 
[ ] Directory of State Officials (annual) 
[ ] Federal Register Summaries 
[ ] Other: ____________________________________________________________

Exhibit 3-15

FORM: EVALUATION OF PROGRAM

(Regional letterhead)

Dear:

This office is making an evaluation of the effectiveness of the of the Commissioning Program for State and Local Regulatory Officials and would appreciate your answering the following questions:

1. Have you exercised the authority of your Commission during the last two years?

___Yes ____No

2. Do you supervise employees holding FDA Commission?

___Yes ____No

3. Do you consider the specifications of authority in your Commission adequate? If no, please provide additional details.

___Yes ____No

4. Has industry questioned your dual role as a State/Local Official and a Federal Officer? If yes, please provide additional details.

___Yes ____No

5. What general/specific comments or suggestions do you have on improving the Commissioning Program?

___Yes ____No

6. Other comments

Exhibit 3-16

ATTACHMENT A - GUIDELINE FORMAT

MEMORANDUM OF UNDERSTANDING

BETWEEN

(INSERT NAME OF STATE AGENCY)

AND

(DISTRICT/REGION)

FOOD AND DRUG ADMINISTRATION

Exhibit 3-16

ATTACHMENT A - GUIDELINE FORMAT

FORMAT

I. Purpose

II. Background

III. Substance of Memorandum of Understanding

A. General Provisions

B. FDA Agrees To:

C. State Agency Agrees To:

IV Name and Address of Participating Agencies

V. Liaison (Designees from each Agency)

Name, Title

Address

Telephone

VI. Period of Agreement (limited or indefinite)

VII. Approval - Acceptance (Signatures, Title, Date)

Exhibit 3-16

ATTACHMENT A - GUIDELINE FORMAT

(MOU TITLE)

I. PURPOSE: This agreement establishes a cooperative program between the (State agency) and the (FDA region/district). This agreement sets forth the working arrangements between the agencies concerning: (e.g., the inspection or investigation of: [insert type inspection or products or name the program area]) in the State of ____________.

II. BACKGROUND: (Briefly describe why the cooperative agreement is needed including phrasing; overall consumer protection will also be enhanced through joint planning and coordination efforts, thereby reducing duplication and providing for more efficient use of combined resources.)

III. SUBSTANCE OF AGREEMENT (This section delineates the work and responsibilities of the agencies.)

A. General Provisions (i.e., the agencies agree to):

B. FDA agrees to:

C. (State agency) agrees to:

The following list of elements may be used to derive the areas applicable to this agreement. One or more of the "options" may be used as appropriate.

Elements

1. Joint Planning

2. Joint Inspections

3. Compliance Activities

4. Disasters

5. Recalls

6. Training

7. Exchange of Inspectional and Analytical Information

8. Pesticide and Mycotoxin Data Exchange

9. Investigation of Foodborne Illnesses

10. Consumer Complaints

Exhibit 3-16 (Continued)

ATTACHMENT A - GUIDELINE FORMAT

Suggested Term(s) of Agreement - (choose one or more option(s))

1. JOINT PLANNING

Option a.
The agencies will meet (e.g., annually,semi-annually), to discuss and plan to assure that resources are efficiently and effectively used. The listing and scheduling of establishments to be inspected by each agency will be completed at these planning meetings.

Option b.
Representatives of the participating agencies will meet periodically to review working arrangements, evaluate accomplishments, maintain program uniformity, and plan future operations.

2. JOINT INSPECTIONS

Either agency may, for training or compliance follow-up purposes, request a joint inspection. The implementation of joint inspections will depend on the availability of personnel and agency priorities.

3. COMPLIANCE ACTIVITIES

Option a.
The agencies will coordinate enforcement actions against persons, firms, or products subject to both Federal and State statutes and inspections.

Option b.
The agency that discovers a violation associated with an inspection will have the primary responsibility to follow through with appropriate compliance activity. Either agency may propose to refer a compliance matter to the other when it appears resolution can best be achieved under the authority of the other agency.

Option c.
Copies of Warning Letters issued to firms will be exchanged in a timely fashion.

Option d.
The agencies will coordinate and maintain close communication on all compliance activities associated with inspections of (type; e.g., food, drug, devices, etc.) establishments in the State of ________.

Exhibit 3-16 (Continued)

ATTACHMENT A - GUIDELINE FORMAT

4. DISASTERS

Disaster Investigation: Each agency will cooperate in the resolution of problems involving contamination caused by such disasters as floods, fires, tornados, common carrier wrecks, chemical spills, etc. Each agency may request assistance from the other on an as-needed basis.

5. RECALLS

Option a.
(Insert name of State agency) will assist FDA in monitoring recalls of products manufactured or distributed in the State of _______. This assistance will be limited to recalls involving products considered by FDA to represent significant health hazards.

Option b.
The FDA region/district will notify (insert name of State agency) of all "hazard to health" recalls involving (food, drug, or devices) manufacturers or repackers within the State of __________. Such notification will generally be made through the Federal-State communications system.

6. TRAINING

Training: Either agency may request training with the understanding that the ability to respond to such a request will depend on the availability of personnel and resources as well as the priorities of the responding agency.

7. EXCHANGE OF INSPECTIONAL AND ANALYTICAL INFORMATION

Information Exchange: FDA and (insert name of State agency) will exchange information regarding firms subject to the jurisdiction of each agency. Information to be exchanged may include: official establishment inventory (OEI); establishment inspection reports (EIRs); and analytical information and compliance activities, which include copies of correspondence with the regulated trade such as Regulatory Letters on Notice of Adverse Findings. EIR's and sample reports will not normally be exchanged when there are no adverse findings. However, the agencies will provide this information if needed to assist the other agency and reduce any duplication of effort.

8. PESTICIDE AND MYCOTOXIN DATA EXCHANGE

Option a.
Pesticide and/or Mycotoxin Program: The agencies will exchange pesticide and (or) mycotoxin analytical results on (insert appropriate term such as all violative, etc.) samples collected within the State of ______________.

Exhibit 3-16 (Continued)

ATTACHMENT A - GUIDELINE FORMAT

Option b.
(________) will provide (________) with results of analyses of food, feed, and related samples, that are examined for pesticides, industrial chemicals, or mycotoxins.

9. INVESTIGATION OF FOODBORNE ILLNESS

Option a.
The agencies will, as necessary, conduct joint inspections of foodborne disease outbreaks. The parties will exchange copies of all investigational and analytical results.

Option b.
The (insert name of State agency) will promptly inform FDA of foodborne illnesses involving commercially prepared food products subject to the Food, Drug, and Cosmetic Act.

Option c.
FDA agrees to inform promptly (name State agency) of foodborne illnesses involving commercially prepared food within the State subject to State or Federal statutes.

10. CONSUMER COMPLAINTS

Consumer complaints regarding (insert description; e.g., food-and drug-related products) will normally be investigated by the agency receiving the initial complaint. The complaint may be referred to the other agency if the situation indicates that the other agency has a greater interest in the matter. Joint inspection may also be conducted.

IV. NAME AND ADDRESS OF PARTICIPATING AGENCIES

A. State Agency

B. Food and Drug Region/District

V. LIAISON OFFICERS

A. For State Agency
Name, Title
Address
Telephone

Exhibit 3-16 (Continued)

ATTACHMENT A - GUIDELINE FORMAT

EXAMPLE:
Director, Compliance Division
(Currently, Joe Doe)
State Department of Health
Room 101, State Office Building
Tel. (Commercial)

B. For FDA

Same format as (A.) above - insert Federal liaison information.

VI. PERIOD OF AGREEMENT

Option a. (indefinite)
This agreement will become effective upon acceptance by each agency and shall remain in effect indefinitely. It may be modified by mutual written consent or may be terminated by either agency upon a 30-day advance written notice to the other agency.

Option b. (Limited)
The agreement, when signed by each agency, will be effective from date of last signature and will expire one year from that date. It may be renewed or modified by mutual written consent or may be terminated by either agency upon 30-day advance written notice to the other agency.

VII. APPROVED AND ACCEPTED APPROVED AND ACCEPTED 
FOR THE FOOD AND DRUG      FOR _____________________
ADMINISTRATION             (NAME THE STATE AGENCY)

BY: _______________________BY: _____________________
TITLE: ____________________TITLE: __________________
DATE: _____________________DATE: ___________________

Exhibit 3-17

ATTACHMENT B - ADDENDUM

MEMORANDUM OF UNDERSTANDING

Between

(Insert Name of State Agency)

and

(Insert Name of FDA Region)

U. S. Food and Drug Administration

ADDENDUM

This addendum authorize the renewal of the agreement developed by the above two agencies for the (insert purpose e.g. coordination of food processing, storage and service, and interstate carrier support inspectional activities) with (insert state or county) without revision for the period ending (insert date).

Approved for the (state agency) by:

______________________________________       ____________
Name and Title               Date

Approved for the (Region, FDA) by:

_______________________________________      ____________
Name and Title               Date