Regulatory Procedures Manual

Chapter 3: COMMISSIONING AND INFORMATION SHARING

COMMISSIONING FEDERAL, STATE, AND LOCAL OFFICIALS

AND SHARING NON-PUBLIC INFORMATION

This chapter contains sections on commissioning, information sharing agreements, and 

information disclosure.

Section Topic Page

3-1 INTRODUCTION ....................................................................................................2

3-2 COMMISSIONING DEFINITION ............................................................................2

3-3 COMMISSIONING AUTHORITIES.........................................................................3

3-4 OTHER INFORMATION SHARING AUTHORITIES...............................................4

3-5 COMMISSIONING AND OTHER INFORMATION SHARING AGREEMENT 

TYPES..............................................................................................................................5

3-5-1 Commissioning Types......................................................................................5

3-5-2 Other Information Sharing Agreement Types...................................................6

20.88 ISA.................................................................................................................. 6

20.85 ISA.................................................................................................................. 6

3-6 COMMISIONING CONFLICT OF INTEREST.........................................................6

3-6-1 Written Assurances..........................................................................................6

3-7 INFORMATION SHARING AND PROTECTION OF NON-PUBLIC 

INFORMATION ................................................................................................................8

3-7-1 Written Assurance............................................................................................8

3-7-2 Protection of Non-Public Information................................................................9

3-7-3 Sharing Non-public Information Under Commission ......................................10

3-7-4 Sharing Non-public Information Under 21 CFR § 20.88 (State or Local) .......11

3-7-5 Sharing Non-public Information Under 21 CFR § 20.85 (Federal) .................12

3-7-6 Information Sharing Training..........................................................................12

3-7-7 Privacy Act.....................................................................................................13
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3-8 COMMISSIONING ADMINISTRATIVE CONSIDERATIONS................................13

3-8-1 Duration .........................................................................................................13

3-8-2 Commissioning Request ................................................................................13

3-8-3 Authorities Granted ........................................................................................14

3-8-4 Suitability for a Commission...........................................................................15

3-8-5 Accountability.................................................................................................16

3-8-6 Renewal of Commission ................................................................................17

3-8-7 Non-renewal of Commission..........................................................................18

3-8-8 Administrative Hold of Commission................................................................18

3-8-9 Suspension of Commission............................................................................20

3-8-10 Revocation of Commission ............................................................................21

3-8-11 Returning of Pocket Credentials ....................................................................22

3-8-12 Relationship with Commissioned Officials......................................................22

3-9 FDA EMPLOYEE ACCEPTING A STATE’S COMMISSION ................................23

3-10 EXHIBITS.............................................................................................................24

Exhibit 3-1: SAMPLE STATE POCKET CREDENTIAL CARD....................................24

Exhibit 3-2: SAMPLE FORM FDA 3716: CERTIFICATE OF COMMISION.................25

3-1 INTRODUCTION

This chapter describes the Food and Drug Administration’s (FDA) procedures and 

responsibilities for commissioning and entering into other information sharing agreements 

(ISA) with other government employees and officials and an overview of information 

sharing with these employees and officials.

3-2 COMMISSIONING DEFINITION

An FDA commission is a delegated authority from the Commissioner of Food and Drugs 

to an individual to act on his/her behalf. A health, food, or drug officer or employee of 

any State, Territory, or political subdivision thereof (herein referred to as “state and local

officials”) may be commissioned to conduct examinations and investigations on FDA’s 

behalf for the purposes of the Act. For example, a commissioned official may work on 

behalf of the FDA under contract, partnership, or for the purposes of other cooperative

agreements. It may be necessary for state or local officials to carry pocket credentials in

cases where they are conducting assignments under FDA authority, such as conducting 

examinations, inspections, investigations or collecting samples, and copying and 
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verifying records. In other cases, it may be necessary for them to only be commissioned

with certificate to receive and review information.

FDA developed its commissioning program to make inter-agency cooperation more 

effective thereby increasing the amount of public health protection afforded to the 

American consumer. FDA achieves its goal by:

1. Permitting commissioned federal, state, and local officials to operate 

under Section 702(a)(1)(A) of the federal Food, Drug, and Cosmetic Act 

(hereafter referred to as the Act).

2. Enabling those commissioned officials to effectively carry out their 

responsibilities by reviewing FDA information, such as draft policy, that is 

protected from disclosure to the public by the Freedom of Information Act 

(FOIA).

A state and local official may be either be commissioned with a certificate of 

commission or pocket credentials. A certificate of commission grants federal authority 

to receive and review non-public information “for use only in their work with the FDA”.

1

Pocket credentials grant federal authority to conduct contract inspections on behalf of 

FDA when the state doesn’t have similar authorities and also grants federal authority to 

receive and review non-public information for use in their work with the FDA.

An EXECUTIVE (EXEC) Certificate of Commission is a specialized subset of the 

certificate of commission. This grant of authority for top state agency officials allows for 

the receipt and review of all FDA program/commodity areas under the official’s purview. 

This certificate is exclusively restricted to top state agency officials that meet the 

following criteria: a) US Citizen or National that is the Head of Agency, or Principle

Deputy/Delegate and b) Directly responsible for more than four program/commodity 

areas. While this grant authority allows access to more commodity specific information 

than other types of commissioning, the holder of an Executive Certificate is still required 

to follow all of the requirements related to the protection of non-public information listed 

within the Commissioning Guide and the Acceptance of Commission Agreement.

This chapter focuses on commissioning of state and local officials, and references 

FDA’s authority to commission officials from other Federal government departments and 

agencies under important provisions regarding the safety and security of regulated 

products, including the Public Health Security and Bioterrorism Preparedness and 

Response Act of 2002 (hereafter referred to as the BT Act); and the Drug Quality and 

Security Act of 2013 (DQSA). It also discusses other types of information sharing 

agreements used to share non-public information with federal, state, and local officials.

3-3 COMMISSIONING AUTHORITIES

Section 702(a)(1)(A) of the Act authorizes FDA “to conduct examinations and 

1 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=20.84
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investigations for the purposes of this Act...through any health, food, or drug officer or 

employee of any State, Territory, or political subdivision thereof, duly commissioned by 

the Secretary as an officer of the Department.”

Section 702(a)(2) of the Act, as amended by the BT Act, authorizes FDA, pursuant to a 

memorandum of understanding, to “conduct examinations and investigations for the 

purposes of the Act through the officers and employees” of other federal departments 

and agencies. Under this provision, FDA may commission other federal officials 

pursuant to a memorandum of understanding between the Secretary and the head of 

the other federal department or agency. Such a memorandum of understanding is only 

effective in the case of examinations or inspections at facilities or other locations that 

are “jointly regulated” by FDA and the other federal agency or department.

Section 503A and 503B of the Act, as amended by the DQSA, requires the Secretary to 

establish a mechanism to receive submissions from state boards of pharmacy 

concerning certain actions taken against compounding pharmacies or expressing 

concerns that a compounding pharmacy may be acting contrary to section 503A. This 

section is to be implemented in consultation with the National Association of Boards of 

Pharmacy (NABP). In addition, state boards of pharmacy must be notified when the 

Secretary receives certain state submissions or makes a determination that a 

compounding pharmacy is acting contrary to section 503A.

FDA’s Office of Regulatory Affairs (ORA), Office of Partnerships (OP) has primary 

responsibility for overseeing the implementation of FDA’s Commissioning Program and 

its maintenance on a national scale. The Program Division Directors (PDDs) have 

primary responsibility for administering and executing the program for commissioning 

state and local officials. Commissioning for tobacco retail contract inspections is 

executed jointly between Center for Tobacco Products (CTP) and OP. For federal 

officials, the inter-agency Memorandum of Understanding (MOU) that is required by the 

BT Act should include provisions regarding the implementation of the commissioning 

procedures. For that reason, those provisions are briefly mentioned.

Individuals seeking commissions should be referred to their relevant FDA District Office 

or State Liaison. The exception is those seeking commissions for tobacco retail 

compliance should contact FDA’s Center for Tobacco Products at 

CTPTrainer@fda.hhs.gov.

3-4 OTHER INFORMATION SHARING AUTHORITIES

Section 21 CFR § 20.88 authorizes FDA to share certain non-public information with 

counterpart state, local and U.S. territory government agencies provided that agency 
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has entered into a written agreement to protect FDA’s information from further 

disclosure. Information shared with these agencies under this section allows FDA’s 

discretionary sharing of authorized non-public information, under certain circumstances 

(see section 3-7 below).

Section 21 CFR § 20.85 authorizes FDA to share certain non-public information with 

non-HHS federal government agencies provided the agency has entered into a written 

agreement to protect FDA’s information from further disclosure.

ORA’s Division of Information Disclosure Policy (DIDP) is responsible for developing 

and maintaining 20.88 and 20.85 agreements. Any state or federal agency should first 

contact DIDP to properly determine if the state and federal agency can enter into such 

an agreement with FDA. Division representatives must also contact DIDP first before 

further sharing any non-public information with any outside agency to ensure proper 

agreements are in place before sharing. DIDP is responsible for oversight in developing 

ORA’s information sharing policies as well as helping administer the sharing of ORA’s 

information with outside parties, including Freedom of Information (FOI) requests. To 

contact DIDP, e-mail ORAInfoShare@fda.hhs.gov .

3-5 COMMISSIONING AND OTHER INFORMATION SHARING 

AGREEMENT TYPES

3-5-1 Commissioning Types

Federal authority can be granted via pocket credentials to state and local officials 

who will actively engage in investigational and inspectional activities on behalf of 

the FDA. FDA may issue pocket credentials to other federal officials pursuant to 

a memorandum of understanding between the Secretary and the head of the 

other federal department or agency (see Exhibit 3-1 for a sample credential). 

Such a memorandum of understanding is only effective in the case of 

examinations or inspections at facilities or other locations that are “jointly 

regulated” by FDA and the other federal agency or department. Adequate 

justification that pocket credentials are needed for inspection or investigation 

activities under federal authority must be provided for all state and local officials 

requesting pocket credentials. Pocket credentials are for official business only for 

inspections and investigations. They shall not be used as a means of personal 

identification or for other personal purposes.

Federal authority can be granted via a certificate of commission to state and local 

officials allowing them to receive and review non-public information. (See Exhibit 

3-2 for a sample certificate of commission).
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Adequate justification that a certificate of commission is required must be 

provided for all state and local officials requesting a certificate of commission. 

Refer to section 3-7 below for information about sharing information under 

commission and section 3-8 below for additional information regarding issues to 

consider prior to commissioning including needs and process for justification.

3-5-2 Other Information Sharing Agreement Types

20.88 ISA

States and local governments can enter into 20.88 information sharing 

agreements with FDA to allow for sharing of FDA information, with limitations 

(see also section 3-7). There are two types of information sharing agreements 

states and local governments can enter into: single-signature long-term and 

case-specific agreements. Entering into either type of agreement doesn’t prevent 

entering into the other. Long-term agreements are commodity specific (food 

(including animal food) and cosmetics; pharmacy compounding and drug 

security; imports; and drugs and biologics) and last a duration of up to 5 years (all 

20.88 agreements expire at the same time, regardless of when entered into with 

FDA). Information can be further shared within the agency with anyone under the 

signatory’s chain of command.

State and local governments may also enter into case-specific agreements, 

especially if entering into long-term agreements aren’t possible. Case-specific 

agreements are written for specific events or situations, allowing ORA to share 

only within what is detailed in the agreement. Information can only be shared 

with those that have signed the confidentiality form. 

20.85 ISA

Similarly, non-HHS federal agencies can enter into 20.85 case-specific 

agreements that allow sharing with the agency/office/division that have signed 

the agreement.

3-6 COMMISIONING CONFLICT OF INTEREST

3-6-1 Written Assurances

1. State or local officials

State or local officials seeking commissioning and Commissioned Officials 

considered for renewal are required to attest in writing, e.g., through the 
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Acceptance of the Commission form, that they do not have certain 

personal financial interests or financial or business relationships with firms 

operating in the specific fields where authority would be granted to the 

official under the commission.

A state or local government employee recommended for a commission 

should discuss questions about the conflict of interest with his/her 

sponsoring FDA district official, or CTP Contract Officer Representative 

(COR). If the candidate/official becomes aware of a potential financial 

interest that would affect participation under the FDA Commissioning 

Program, the sponsoring FDA district official or CTP COR will summarize 

the issues and submit them along with other documentation to the FDA 

Division, OP, and/or CTP for resolution. OP will discuss the matter with the 

PDD/DD, or CTP, and appropriate FDA Ethics Officials; a decision will be 

reached as to whether the individual can be commissioned. OP may 

contact the FDA's Ethics and Integrity Staff (HFA-320). This discussion 

should ideally be conducted in person by the PDD/DD in the case of a 

state agency head. If circumstances make this impractical, a PDD/DD, 

director of state programs, or deputy director may make a visit for this 

purpose 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 or a subordinate official, a PDD/DD, deputy director for 

intergovernmental affairs, or the director of state programs should conduct 

this discussion. 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.

FDA will not commission any official/candidate if determined to have a 

conflict of interest. All issues affecting candidate's financial interests must 

be resolved prior to granting a commission.

The FDA commissioned official must remain free from financial interests 

that may affect the specified authorities in the FDA commission. If the 

official acquires a financial interest after receiving a commission, he/she 

must notify FDA and not participate in any assignment related to the 

financial interest.
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If problems arise about the commissioned status of any official, FDA’s 

resolution may range from disqualification from participating in any 

commission related activities pertaining to the firm, to the revocation of the 

commission and return of the FDA pocket credentials. If FDA determines 

that the problem is resolved, it may consider commissioning the official 

again.

2. Federal officials

For federal officials, the governing MOU may contain provisions about the 

conflict of interest standard, e.g., the standard that is imposed by that 

other federal agency.

3-7 INFORMATION SHARING AND PROTECTION OF NON-PUBLIC 

INFORMATION

3-7-1 Written Assurance

Outside agencies, whether entering into either a commission or an information 

sharing agreement with FDA, must be able to maintain the confidentiality of any 

and all information FDA shares, unless ORA has reviewed and approved the 

information for further disclosure. For example, state or local officials seeking a 

commission or commission renewal are required to attest in writing, e.g., through 

the Acceptance of Commission form for commissioning or the Tobacco 

Acceptance of Commission form for tobacco commissioning, that they 

understand that any non-public information FDA provides for review is entitled to 

significant protection under federal law. The state or local official further 

understands that if they make any unauthorized disclosures of non-public 

information, they may be committing a possible violation under federal Law (21 

U.S.C. § 331(j), 5 U.S.C. § 552a(i)(1), and 18 U.S.C. § 1905) which could result 

in civil or criminal penalties including fines and/or imprisonment In long-term 

20.88 and 20.85 agreements, agency or department signatories attest to a 

confidentiality commitment for their organization contained within the agreement 

establishing that the state or federal government agency has the authority to 

protect the non-public information from disclosure and the government agency 

will not further disclose any such information provided to it. Furthermore, a singlesignature non-disclosure agreement, is signed by state agencies awarded 

contracts. These commitments apply to anyone under the signatory’s chain of 

command. In case-specific 20.88 and 20.85 agreements, individuals receiving 

non-public information must sign the agreement’s confidentiality form.
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3-7-2 Protection of Non-Public Information

FDA may share “non-public information” outside of FDA for various reasons (for 

example, during an outbreak investigation). Non-public information generally 

includes confidential commercial information, trade secrets information), 

deliberative process, open investigatory records, and personal privacy 

information). This may include, but not limited to: written reports, manufacturing 

and production techniques, equipment used, official FDA documents, etc. The 

only individuals eligible to see or hear FDA-provided non-public information are:

a) Commissioned officer(s) who collected or received the information 

that have a valid FDA use for the information,

b) An employee at the same state/territorial agency who also holds

an FDA commission within the same commodity area,

c) Officers or employees of the Food and Drug Administration or the 

Department of Health and Human Services,

d) Any state official covered by an appropriate 20.88 information 

sharing agreement (with the exception of trade secret information),

e) Any non-HHS federal official covered by an appropriate 20.85 

information sharing agreement (with the exception of trade secret 

information).

f) A state official covered by a state contract’s single signature nondisclosure agreement.

Information obtained during a contract inspection, through FDA systems, or any 

other information obtained pursuant to a commission by a commissioned official 

is an official FDA record. Information obtained pursuant to a commission is for 

that official’s use exclusive in their work with the FDA unless further disclosure is 

authorized by FDA. Information shared by FDA under commission cannot be 

copied into state memoranda, emails, or other documents, or discussed with 

individuals not covered above, without first consulting FDA. If in doubt, consult 

with FDA. Any requests to further share FDA’s information received beyond that 

which is authorized in the above paragraph should be referred to ORA’s Division 

of Information Disclosure Policy (DIDP) at ORAInfoShare@fda.hhs.gov.

Pursuant to 21 U.S.C. § 372(a), commissioned state and local government 

officials are “officers” of the U.S. Department of Health and Human Services, 

making them subject to the same disclosure restrictions and penalties as any 

other employee of FDA. Any public requests for information shared by FDA under 

a commission, including FDA contract inspections performed by an agency using 

FDA authority, are to be directed to file a Freedom of Information Act request 

directly with the FDA FOIA office to obtain copies of those records. Information 

obtained during an inspection by a commissioned official is an official FDA record 
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and may not be disclosed by an agency in response to such a request. If 

presented with a formal request or subpoena for information obtained in the 

course of using the FDA commission, the commissioned official or state agency 

should immediately contact ORA’s DIDP at ORAInfoShare@fda.hhs.gov.

Information shared under 20.88 or 20.85 information sharing agreements must be 

first reviewed and redacted for trade secret information. Per 21 CFR § 20.61 and 

21 U.S.C. § 331(j), trade secret information cannot be shared under any of these 

agreements. Information shared under either of these types of agreements can 

be used by states to inform decisions made by the agency (i.e., state-level 

compliance actions, the need for non-contract inspections, etc.).

Further, while FDA’s sharing of personal privacy information is discretionary, 

FDA’s practice is not to share any personal privacy information with any non-FDA 

federal (including other HHS agencies), state, or local agencies, including any 

whistleblower information. This includes any information that could potentially aid 

anyone to determine a whistleblower or complaint’s identity. FDA may decide to 

share certain personal privacy information only if a substantive rationale is 

provided in order to complete follow up work as needed. In addition, some 

information containing personal privacy information is subject to the Privacy Act 

and may not be shared under these agreements unless authorized under the 

Privacy Act (e.g., written consent or a routine use). Prior to releasing any 

personal privacy information, DIDP should be contacted before any information 

disclosure occurs. Redactions in any of these situations, or questions regarding 

the need to redact, are to be directed to DIDP at ORAInfoShare@fda.hhs.gov.

3-7-3 Sharing Non-public Information Under Commission

FDA may provide a state or local official commissioned in a commodity area to 

“receive and review FDA information”, with information for use only for their work 

with the FDA (including for situational awareness). The information shared may 

only pertain to their authorized commodity area if it is protected from disclosure to 

the public by the Freedom of Information Act (see 21 CFR § 20.84). Per this 

regulation, this information may not be used to inform state action and is for use 

only in their work with the Food and Drug Administration.

Trade secret information can be shared under a commission (either credential or 

certificate) for a valid FDA use. Personal privacy information is not be shared 

outside of FDA unless the non-FDA user can demonstrate a sustainable need for 

that information (see above section on sharing of non-public information).

To verify an individual’s commission and their approved commodity area prior to 

transmitting information, please contact StateCommissioning@fda.hhs.gov for 
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access to the Commissioning Officials database and for any other questions you 

might have regarding commissioning. 

Commissioned officials may only further share FDA information with members of 

their staff who hold FDA commissions within the same commodity program area, 

or an official with an Executive Certificate of Commission specifying that they can 

receive and review official FDA documents. The information may not be copied 

into state memoranda, emails, or other documents, or discussed with 

noncommissioned officials. Any requests to further share FDA information 

received pursuant to a commission beyond that which is authorized should be 

referred to ORA’s Division of Information Disclosure Policy at 

ORAInfoShare@fda.hhs.gov. 

Whenever FDA provides non-public information to commissioned officials, in 

accordance with the Act and FDA regulations, FDA should indicate the 

information is non-public by affixing a transmittal letter which cautions the 

recipient against further disclosure, marking the documents with a non-public 

information coversheet , password encrypting electronic files where possible, and 

adding E-mail and oral disclaimers , as appropriate. When sending documents 

via non-electronic means, the document’s envelope should be identified "To Be 

Opened By Addressee Only."

3-7-4 Sharing Non-public Information Under 21 CFR § 20.88 (State or Local)

FDA may share certain non-public information pursuant to 21 CFR § 20.88(c) and 

(d) with state and local officials, as part of cooperative law enforcement or 

regulatory efforts. This information may be used to inform a state action (i.e., 

state-level compliance actions, the need for non-contract inspections, etc.). For 

FDA to share non-public information, there must be a written statement from the 

state agency establishing that the State government agency has the authority to 

protect the non-public information from disclosure and a written commitment that 

the State government agency will not further disclose any such information 

provided to it. This is called a case-specific 20.88 agreement. 

Any documents shared under 21 CFR § 20.88 must have an information 

disclosure review performed to redact all trade secret information and should not 

include personal privacy-related information unless there is a demonstrated need 

by the state agency for the information. When transmitting the records FDA 

indicates that the information is non-public, e.g., by affixing a transmittal letter or 

disclaimer language in an email which cautions the recipient against further 

disclosure, marking the documents with a non-public information coversheet , 

password encrypting electronic files where possible, etc. 
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To verify an agency is currently covered under a long-term sharing agreement, 

check the 20.88 Long Term Information Sharing Agreement Database or check 

with DIDP at ORAInfoShare@fda.hhs.gov. Any records request not covered 

under a long-term agreement should be forwarded to DIDP for authorization, with 

a copy to the relevant State Liaison.

For any questions you might have regarding the sharing of non-public information 

with a state or local entity, please contact DIDP at ORAInfoShare@fda.hhs.gov.

3-7-5 Sharing Non-public Information Under 21 CFR § 20.85 (Federal)

FDA may share certain non-public information with another federal agency under 

21 CFR. §20.85 (Disclosure to other federal government departments and 

agencies). ORA’s Division of Information Disclosure Policy (DIDP), Office of 

Strategic Planning and Operational Policy (OSPOP) manages all 20.85 

agreements for the FDA. Any requests for records from a federal agency should 

be forwarded to the DIDP at ORAInfoShare@fda.hhs.gov with a copy to the 

relevant State Liaison.

For FDA to share confidential commercial information, pre-decisional information, 

open investigatory records, and personal privacy information, there must be a 

written statement from the federal agency establishing that the federal agency 

has the authority to protect the non-public information from disclosure and a 

written commitment that the federal agency will not further disclose any such 

information provided to it. Trade secret information may not be shared under 

20.85 agreements. Personal privacy information pertinent or in furtherance of the 

agency’s investigation may be released under a 20.85 authorization.

Any documents shared under a valid 20.85 agreement must have an information 

disclosure review performed to redact all trade secret information and should not 

include personal privacy-related information unless there is a demonstrated need 

by the state agency for the information. When transmitting the records FDA

indicates that the information is non-public, e.g., by affixing a transmittal letter (or 

use transmittal letter language in an email) which cautions the recipient against 

further disclosure, marking the documents with a non-public information 

coversheet , password encrypting electronic files where possible, etc.

For any questions you might have regarding the sharing of non-public information 

with a federal entity contact DIDP at ORAInfoShare@fda.hhs.gov.

3-7-6 Information Sharing Training

It is imperative that non-public information remains secure and confidential after 

changing hands. The FDA Information Sharing Training module is designed to 
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clarify the roles and responsibilities of recipients of various types of non-public 

information, and it is highly recommended for all of FDA’s state and local partners 

and those FDA employees involved with those partners.

See the FDA Information Sharing webpage

3-7-7 Privacy Act 

The FDA District Office, CTP, Office of Security Operations, and the Office of 

Partnerships maintain records on individuals who have applied to be 

commissioned (i.e., photograph, commissioning application package).

Any person may review his or her own file by requesting a copy of it from the 

Division of Freedom of Information under the Privacy Act. All other questions 

about Privacy Act records should be addressed to:

Food and Drug Administration

Division of Freedom of Information

Office of the Executive Secretariat, OC 

5630 Fishers Lane, Room 1035

Rockville, MD 20857

301-796-3900 (main)

301-827-9267 (fax)

FDAPrivacyOffice@fda.hhs.gov

3-8 COMMISSIONING ADMINISTRATIVE CONSIDERATIONS

3-8-1 Duration

Generally, each state or local commission is issued for a period of five years. At 

the end of each five-year term, FDA will review the commission and determine 

whether it should be renewed. For federal commissioned officials, the MOU 

should include the duration of commission, which might be a term other than five 

years.

3-8-2 Commissioning Request

A formal request for a commission is considered when a completed application is 

received by the district for traditional commissioning and CTP for Tobacco.

A Certificate of Commissioning application packet or tobacco application packet

includes, a completed and signed Basic Information From a Candidate for an 

FDA Commission and Acceptance of Commission forms. Additional reference 

materials are distributed with the application packet, i.e., Instructions to 
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Candidates for an FDA Traditional Commission and The FDA Commission:

Granting Federal Authority to State and Local Officials.

3-8-3 Authorities Granted

An individual commissioned by FDA must understand the nature of the federal 

authority that is granted. It may be used only for the stated purposes when acting 

on behalf of FDA and does not delegate any federal authority beyond that 

specified. The authorities granted by an FDA commission are valid only for the 

specific program area(s) for which the candidate applies, up to a maximum of 

four (4) programs, excluding the Executive Certificate of Commission. The 

program areas include: 

Bioterrorism, Animal Feeds, Biologics, BSE Activity, Cosmetics, Dairy, Drugs, 

Eggs, Foods, Medical Devices, Produce, Pesticide Residue, Radiological 

Health, Shellfish, and Tobacco.

An FDA commission confers upon the recipient the authority to perform activities 

in designated program areas as a federal official within their own state or local 

jurisdiction. A commission with pocket credentials permits the holder to perform 

the following activities:

1. Conduct examinations, inspections, and investigations

2. Collect samples

3. Copy and verify records

4. Receive and review FDA documents

Commissioned officials who will be performing activities 1 and 2 above may be 

requested to show when entering a firm for an inspection. The firm is only 

required to admit inspectors with up-to-date credentials in an appropriate 

program area.

A Certificate of Commission and the Executive Certificate of Commission allows 

the commissioned official to perform activities 3 and 4, listed above. Any records 

received under activities 1- 4 above should be identified and stored as FDA 

records.

Additionally, information directly related to an FDA contract can be shared with 

anyone working on that contract without the need for a commission. Employees 

receiving non-public information under an FDA contract must be covered under 

the Single Signature Non-Disclosure Agreement.
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3-8-4 Suitability for a Commission

To be considered for an FDA commission, the applicant must be a citizen of the 

United States or a United States National. Nationals are persons born in an 

outlying possession of the United States (American Samoa or Swains Island) or 

born of a parent or parents who are non-citizen nationals who meet certain 

physical presence or residence requirements. Permanent residents and green 

card holders are not US nationals and are not eligible for commissioning.

PDDs/DDs are approving authorities for commission requests. Requests must be 

accompanied by a justification as to why a commission is required in performing 

work for the FDA. PDDs/DDs are required to provide a justification for all 

Certificate of Commission approved requests as to why a 20.88 agreement will 

not suffice for information sharing purposes. The justification must also make 

clear that the use of the information shared with the commissioned individual 

won’t be used for further work outside of that with FDA.

Prior to issuing a commission, FDA will determine that the candidate is qualified 

to carry out the duties of a commissioned official. In most cases, the sufficiency of 

the individual's qualifications will be stipulated by their agency; however, FDA 

reserves the right to inquire further into the candidate's qualifications. In addition, 

FDA will conduct a Minimum Background Investigation (MBI) - Level 5 Moderate 

Risk Public Trust investigation via the Electronic Questionnaires for Investigations 

Processing (e-QIP) system for all pocket credential requests and, in some cases,

certificate of commission requests, if deemed appropriate by the PDD/DD.

Candidates will be required to complete the e-QIP Initiation Form to be given 

access to the e-QIP system. Candidates will electronically enter data for review 

and submission to the Office of Personnel Management (OPM). The e-QIP 

system is part of E-GOV, which is an integral part of the President’s Management 

Agenda (PMA). The MBI will consist of searches of records covering specific 

areas of an individual’s background during the past ten years. Inquiries are sent 

to current and past employers, schools attended, references and local law 

enforcement authorities. A credit check and face to face interview with an 

investigator will also be conducted. 

The Office of Personnel Management’s (OPM) Federal Investigative Services 

(FIS) conducts background investigations on federal applicants, employees, 

contractor personnel, and commissioning candidates for suitability and security 

determination purposes. A credit search is a routine part of many of these 

investigations. The subjects of background investigations are requested to sign a 

release form allowing a check of his or her credit history. Searches are conducted 

for each name variation a person has used; therefore, there may be more than 
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one search by OPM showing on a person’s credit report. Credit inquiries from 

OPM investigations are included in the Regular Inquiries portion of a credit 

record, but these inquiries are “soft” hits and do not have an impact on a person’s 

credit score. Failure to provide FDA with required information within the allotted 

timeframe will result in a denial for the commission request. 

If an individual already possesses a background investigation, the investigation 

will be reviewed by FDA. If the investigation is compliant with FDA standards, the 

individual will not need to undergo an additional investigation.

FDA Form 2115s State Credentialing Record is required for all candidates 

requesting to be commissioned with pocket credentials. A copy of this form in 

provided to the candidate in the application packet or tobacco application packet. 

3-8-5 Accountability

The commissioning candidate is responsible for contacting FDA when:

• A conflict of interest arises

• An ethical dilemma arises in which a conflict of interest could arise

• Any potential unauthorized or inadvertent release of non-public 

information 

• Any civil, criminal, or illegal activity which could jeopardize the Level 

5 MBI obtained by the individual

• When a credential is lost or stolen. 

• When a subpoena is received for information that was obtained 

under a commissioning agreement 

FDA reserves the right to deny, administratively hold, suspend, or revoke a 

commission at any time. In some instances, FDA may pursue civil or criminal 

charges if the commissioned official is not upholding his or her duties as a 

commissioned official. Grounds for action may include the following:

a. Charges of a felony.

b. Charges of a misdemeanor, excluding minor traffic offenses where 

the fine is less than $500.

c. Pending trial for a felony or misdemeanor charge, excluding minor 

traffic offenses where the fine is less than $500.

d. Pending investigation related to a felony or misdemeanor charge, 

excluding minor traffic offenses where the fine is less than $500.

e. The abuse or misuse of the commission.

f. The transmittal of confidential information from a commissioned state 

or local official to individuals who are not employees or 

commissioned officials of the Department of Health and Human 
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Services.

g. A conflict of interest.

h. Change in criminal or credit history. 

i. Conviction of a crime.

j. Substance abuse.

k. Behavior that may discredit the agency.

l. Inappropriate disclosure of non-public information.

m. Contract discrepancies.

n. FDA policy violations.

o. Programmatic hurdles.

Credentials are considered federal government property. Therefore, the credential 

must be returned to FDA if the commissioned official leaves the state or local agency 

or otherwise no longer has a need for the credential. The certificate of commission 

does not need to be returned to FDA upon its expiration.

3-8-6 Renewal of Commission

1. State or local officials

Commissions of state or local officials are valid for five years. The district 

will review the commissioned official’s record approximately three (3) 

months prior to expiration of the commission and notify the applicant’s 

supervisor of the impending expiration. This review considers all pertinent 

aspects of the commission including inspections, collection of samples, 

consultation extended, cooperation in routine and emergency situations, 

and any breaches of confidentiality. For state or local officials, a completed 

application package for traditional commissioning should be sent to the 

District, from the state or local official, signaling the intent to request a 

renewal. 

Office of Partnerships will work with CTP and State Program Coordinators 

to renew tobacco retail compliance commissions.

Application packets for tobacco and non-tobacco are specific to those 

programs.

All renewal applications from the state agency should be entered into the 

National Commissioning Inventory (NCI) to be routed for approval and

processing. ORA has the option to conduct a background investigation at 

any time during the renewal process, if deemed necessary.

2. Federal officials
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For federal officials, the MOU should contain provisions about the duration 

of the commission and procedures about renewal of a commission.

3-8-7 Non-renewal of Commission

1. State or local officials

ORA reserves the right to deny renewal commissioning requests. The 

PDD/DD will consider the state agency needs, justification, and make a 

decision based on all pertinent aspects of the commission including 

inspections, collection of samples, consultation extended, cooperation in 

routine and emergency situation, non-public document review, and any 

breaches of confidentiality. FDA will not renew a commission if the holder 

has changed positions outside of the organization/agency, resigned, or 

retired. All renewal applications in progress will be withdrawn if the official 

changes positions outside the organization/agency, resigns, or retires. If the 

commissioning request is not renewed, the district aided by the NCI with 

OP’s Commissioning Team’s signature block or in cases of tobacco, CTP, 

will send a notification to the applicant and their supervisor advising of the 

decision.

2. Federal officials

For federal officials, the governing MOU may contain provisions about nonrenewal of a commission.

3-8-8 Administrative Hold of Commission

1. General

ORA may use discretion at any time to administratively hold the commission 

of such authorized officials on the grounds of violations.

The decision to administratively hold an FDA commission will be 

communicated within 30 calendar days to both the individual and his/her 

supervisor.

2. State or local officials

For commissioned state or local officials, within ten (10) calendar days after 

receiving a felony or misdemeanor charge (or pending trial or investigation), 

or after violation for an administrative hold has occurred, details of the 

applicable charge or violation must be communicated to their employer, and 

to the PDD/ DD, deputy director, executive official, director of state 

programs, or other official specifically charged with oversight of the 
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commissioning program. 

Within five (5) calendar days after receiving details of the charge or 

violation, the PDD/DD must inform OP’s National Commissioning 

Coordinator at StateCommissioning@fda.hhs.gov. OP’s National 

Commissioning Coordinator will work with Office of Security Operations and 

OP Senior Management to decide if an administrative hold of the 

commission is required. After a decision has been reached, the OP National 

Commissioning Coordinator will recommend the appropriate action, to the 

PDD/DD specifically charged with oversight of the commissioning official.

If an administrative hold of commission is not required and the PDD/DD 

concurs, a letter signed by OP’s Commissioning Team should be sent to the 

district to notify the agency head stating that no further action will be taken.

If an administrative hold of commission is required and division concurs, a 

letter signed by OP’s Commissioning Team should be sent to the district for 

dissemination to the agency head stating the details of the administrative 

hold and requesting that all commissioning instruments and any documents 

belonging to FDA be collected and returned to OP. The documents and all 

additional documentation from the division must then be sent via e-mail to 

StateCommissioning@fda.hhs.gov.

Once a commission has been administratively held, the FDA will wait for the 

final verdict of the charge or violation to make its decision on 

revoking/suspending or reinstating the commission. If the state or local 

official is not charged with the felony or misdemeanor, or in violation of any 

of the mentioned scenarios, FDA will use discretion to reinstate their 

commission. A follow up letter signed by OP’s Commissioning Team 

including the commissioning instruments, should be sent to the district for 

distribution to the agency head stating the decision to reinstate. 

If the state or local official is charged with the felony or misdemeanor, or in 

violation of any of the mentioned scenarios, their commission will be 

revoked/suspended immediately. A follow up letter signed by OP’s 

Commissioning Team should be sent to district to notify the agency head 

stating the decision of revocation/suspensions. Once a commission has 

been revoked/suspended, that individual is no longer eligible for an FDA 

commission.

If there is a dissenting opinion between the PDD/DD and another FDA 

official regarding the administrative hold of an individual’s commission, the 

ACRA, or appropriate senior ORA official, will be consulted for a final 
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decision.

3-8-9 Suspension of Commission

1. General

ORA may use discretion at any time to suspend the commission of such 

authorized officials on the grounds of violations.

The decision to revoke or suspend an FDA commission will be 

communicated within 30 calendar days to both the individual and his/her 

supervisor.

2. State or local officials

For commissioned state or local officials, within ten (10) calendar days after 

receiving a felony or misdemeanor charge (or pending trial or investigation), 

the details of the applicable charge must be communicated to their 

employer, and to the PDD/ DD, deputy director, executive official, director of 

state programs, or other official specifically charged with oversight of the 

commissioning program. 

Within five (5) calendar days after receiving details of the charge, the 

PDD/DD must inform OP’s National Commissioning Coordinator at 

StateCommissioning@fda.hhs.gov. OP’s National Commissioning 

Coordinator will work with Office of Security Operations and OP Senior 

Management to decide if suspension of the commission is required. After a 

decision has been reached, the OP National Commissioning Coordinator 

will recommend the appropriate action, to the PDD/DD specifically charged 

with oversight of the commissioning official.

If suspension of commission is not required and the PDD/DD concurs, a 

letter signed by OP’s Commissioning Team should be sent to the district to 

notify the agency head stating that no further action will be taken.

If suspension of commission is required and division concurs, a letter signed 

by OP’s Commissioning Team should be sent to the district for 

dissemination to the agency head stating the details of the suspension and 

requesting that all commissioning instruments and any documents 

belonging to FDA be collected and returned to OP. The documents and all 

additional documentation from the division must then be sent via e-mail to 

StateCommissioning@fda.hhs.gov.

Once a commission has been suspended, the FDA will wait for the final 

verdict of the charge to make its decision on revoking or reinstating the 
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commission. If the state or local official is not charged with the felony or 

misdemeanor, FDA will use discretion to reinstate their commission. A 

follow up letter signed by OP’s Commissioning Team including the 

commissioning instruments, should be sent to the district for distribution to 

the agency head stating the decision to reinstate. 

If the state or local official is charged with the felony or misdemeanor, their 

commission will be revoked immediately. A follow up letter signed by OP’s 

Commissioning Team should be sent to district to notify the agency head 

stating the decision of revocation. Once a commission has been revoked, 

that individual is no longer eligible for an FDA commission.

If there is a dissenting opinion between the PDD/DD and another FDA 

official regarding the suspension of an individual’s commission, the ACRA, 

or appropriate senior ORA official, will be consulted for a final decision.

3-8-10 Revocation of Commission

1. General

ORA may use discretion at any time to revoke the commission of such 

authorized officials on the grounds of violations.

The decision to revoke an FDA commission will be communicated in 30 

calendar days to both the individual and his/her supervisor.

2. State or local officials

For state or local officials, within ten (10) calendar days after violation for 

revocation has occurred, details of the violation must be communicated to 

their place of employment who must then communicate the details to the 

FDA PDD/DD, deputy director, executive official, director of state programs, 

or other official specifically charged with oversight of the commissioning 

program. Within five (5) calendar days after receiving details of the charge, 

the Division must inform the Office of Partnership’s National Commissioning 

Coordinator. 

The Office of Partnership’s National Commissioning Coordinator will work 

with Office of Security and the Office of Partnership’s senior management to 

decide if revocation of commissions is required. After a decision has been 

reached, the Office of Partnership’s National Commissioning Coordinator 

will recommend the appropriate action to the PDD/DD specifically charged 

with oversight of the commissioning official.

If the PDD/DD concurs, a letter signed by OP’s Commissioning Team 
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should be sent to district to notify the agency head stating the details of the 

revocation and requesting that the commissioning instruments, and any 

documents belonging to FDA be collected and returned to OP. The 

documents and all additional documentation from the Division office must 

then be sent via e-mail StateCommissioning@fda.hhs.gov. 

Original certificates and credentials should be returned by mail. Once a 

commission has been revoked, that individual is no longer eligible for an 

FDA commission. If there is a dissenting opinion between the PDD/DD and 

another FDA official regarding the revocation of an individual’s commission, 

the ACRA will be consulted for a final decision.

3. Federal officials

For federal officials, the MOU may contain provisions about revocation of a 

commission.

3-8-11 Returning of Pocket Credentials

It is the responsibility of the state agency to return all FDA issued pocket 

credentials when no longer needed. Examples include expired credentials, 

individuals that have retired or changed agencies, or when no longer needed to 

conduct inspections under FDA authority. The expired pocket credentials must be 

returned to the State Liaison in their respective district office for processing and 

then forwarded to Office of Partnerships. Tobacco retail compliance credentials 

should be returned directly to the OP Tobacco Commissioning Coordinator.

3-8-12 Relationship with Commissioned Officials

FDA's relationship with state and local agencies is very important, because close 

coordination and cooperation provides a high level of consumer protection. State 

and local officials who hold FDA commissions help FDA enforce its laws and 

regulations. 

To encourage closer ties with cooperating state and local officials who hold FDA 

commissions, to inform them about FDA, and to let FDA benefit from their 

knowledge and experience, the PDD/DD should consider the following:

• Literature and publications

The manuals listed below are available on the FDA internet and can 

be accessed at: www.fda.gov. For further assistance please contact 

OP at StateCommissioning@fda.hhs.gov.

1. FDA Inspection References
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a. Investigations Operation Manual 

b. FDA Compliance Policy Guides Manual 

c. FDA Regulatory Procedures Manual

2. Catalog of Courses and Training Materials

3. Laboratory Information Bulletin

4. Orange Book: Approved Drug Products With Beneficial 

Equivalence Evaluations

5. FDA Information Sharing Course

6. Section 702(a) of the Federal Food, Drug and Cosmetic 

Act (21 USC 372)

7. 21 CFR §20.88 Communications with State and local 

government officials 

8. SMG 2280.3 – FDA Official Credentials and Badges

9. SMG 3297.4 – Implementation of the Privacy Act and the 

FDA Privacy Program: Overview

3-9 FDA EMPLOYEE ACCEPTING A STATE’S COMMISSION

Rarely, an FDA investigator may find it valuable to exercise state powers. For example, 

an FDA investigator may wish to obtain a state commission to have the ability to place 

an embargo in those cases when a state official, who has the authority to do so, is not 

available. An FDA investigator may hold a state commission provided that:

The commission is offered by a state agency whose agency head holds an FDA 

Commission.

The commission is not used unless a state official, authorized by the state regulatory 

agency, has given prior permission to use the state commission in each specific 

contemplated use. The supervisor of the FDA investigator should agree to the 

contemplated use of the commission.
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3-10 EXHIBITS

Exhibit 3-1: SAMPLE STATE POCKET CREDENTIAL CARD
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Exhibit 3-2: SAMPLE FORM FDA 3716: CERTIFICATE OF COMMISION