RegulatoryProceduresManual

 Chapter 10: OTHER PROCEDURES

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This chapter includes the following sections: 

Section Topic Page

10-1 COMMUNICATIONS – OFFICE OF REGULATORY AFFAIRS AND CENTER 

RESPONSIBILITIES ....................................................................................................... 4

10-1-1 Regulatory Actions that Require Center Concurrence................................... 4

10-1-2 Regulatory Actions prepared by a Center for Program Issuance and/or 

Follow-up ..................................................................................................................... 5

10-1-3 Debarment - Notification Responsibilities of FDA Employees ....................... 5

10-2 PRIOR NOTICE.................................................................................................. 10

10-2-1 Purpose....................................................................................................... 10

10-2-2 Background ................................................................................................. 10

10-2-3 Prior Notice.................................................................................................. 10

10-2-4 Procedures.................................................................................................. 11

10-3 REGULATORY MEETINGS ............................................................................... 12

10-4 INSPECTION OF FOOD RECORDS – SECTIONS 414(a) and 704(a).............. 13

10-4-1 Purpose....................................................................................................... 13

10-4-2 Authority ...................................................................................................... 13

10-4-3 Statutory requirements for invoking records inspection authority ................ 15

10-4-4 Records that may be accessed and copied under this authority ................. 16

10-4-5 Records that may not be accessed and copied under this authority ........... 16
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10-4-6 Procedure for Invoking Records Inspection Authority.................................. 16

10-4-7 Issuing Form FDA 482c............................................................................... 18

10-4-8 Timeframes for compliance ......................................................................... 18

10-4-9 Failure to provide records............................................................................ 19

10-5 ESTABLISHMENT INSPECTION REPORT (EIR) CONCLUSIONS AND 

DECISIONS .................................................................................................................. 19

10-5-1 Release of the Establishment Inspection Report......................................... 19

10-5-2 No Action Indicated (NAI) and Voluntary Action Indicated (VAI) 90 day 

Decisional Letters for Drug Inspections ..................................................................... 19

10-6 INTERSTATE TRAVEL PROGRAM (ITP) CLASSIFICATIONS AND 

ADMINISTRATIVE ACTIONS ....................................................................................... 19

10-7 REPORTING AND MONITORING ..................................................................... 19

10-8 AD HOC COMMITTEE....................................................................................... 20

10-8-1 Purpose....................................................................................................... 20

10-8-2 Function....................................................................................................... 20

10-8-3 Composition ................................................................................................ 20

10-8-4 Procedures.................................................................................................. 21

10-8-5 Responsibilities ........................................................................................... 22

10-9 APPEAL PROCESS........................................................................................... 23

10-9-1 Purpose....................................................................................................... 23

10-9-2 Who May Appeal......................................................................................... 23

10-9-3 What May Be Appealed............................................................................... 23

10-9-4 When An Appeal Is Not Appropriate............................................................ 23

10-9-5 Requests For Appeal................................................................................... 24

10-9-6 Review Of Appeals...................................................................................... 24
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10-9-7 Decision On Appeals................................................................................... 24

10-10 EXPERT SUPPORT FOR CASES ..................................................................... 25

10-10-1 Purpose....................................................................................................... 25

10-10-2 Responsibility .............................................................................................. 25

10-10-3 Criteria For Determining The Level Of Expert Support................................ 25

10-10-4 Documentation ............................................................................................ 26

10-10-5 List Of Individuals For Expert Support......................................................... 26

10-10-6 Obtaining And Paying For Expert Support................................................... 26

10-11 TESTIMONY; PRODUCTION OF RECORDS; CERTIFICATION OF RECORDS...... 29

10-11-1 Requests for Testimony............................................................................... 29

10-11-2 Requests for Production of Records............................................................ 32

10-11-3 Multi-issue Subpoena - Requests for Samples............................................ 33

10-11-4 Requests for Certification of Records.......................................................... 33

10-11-5 Requests involving Special Circumstances................................................. 33

10-11-6 Disclosure of Non-public information........................................................... 34

10-11-7 Other Requests for Information – Informal Meetings................................... 35

10-11-8 Definitions.................................................................................................... 36

10-11-9 References.................................................................................................. 37

10-12 U. S. CONGRESSIONAL REQUESTS – INSTRUCTIONS FOR ORA 

EMPLOYEES................................................................................................................ 38

10-13 REQUESTS FROM STATE AND FEDERAL OFFICIALS – INSTRUCTIONS FOR 

ORA EMPLOYEES ....................................................................................................... 40

10-13-1 Background ................................................................................................. 40

10-13-2 Procedures for Handling Inquiries from State Congressional Officials and 

their Staff ................................................................................................................... 41
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10-13-3 Procedures for Handling Inquiries from Federal Agencies .......................... 43

10-13-4 Procedures for Handling Inquiries from Other State, Local, Tribal, and 

Territorial Government Officials and National Associations ....................................... 43

10-14 APPLICATION INTEGRITY POLICY.................................................................. 45

10-15 EXHIBIT ............................................................................................................. 46

10-1 COMMUNICATIONS – OFFICE OF REGULATORY AFFAIRS AND 

CENTER RESPONSIBILITIES

10-1-1 Regulatory Actions that Require Center Concurrence

When a decision is made by the Program Division that initiation of a regulatory action is 

appropriate, the Division should notify the appropriate Center compliance unit regarding 

its intent to submit a recommendation. Division Compliance staff should also remember 

to enter the “In Review” profile status as “pending” on the Maintain Profiles screen in 

eNSpect for each profile class covered when the recommendation is a result of a 

Current Good Manufacturing Practice (CGMP) or Quality System (QS) inspection of a 

domestic drug, biologics, or medical device facility. Compliance staff should also notate 

the Remarks field to explain the action being recommended. When the action 

recommendation is forwarded to a Center for review, the Remarks field should be 

updated to reflect that and include the date forwarded. With regard to foreign 

inspections, Center Compliance staff are responsible for the review and evaluation, and 

should enter the In Review “pending” status and notate the corresponding Remarks field 

as appropriate. See “Firm Profile Updates in eNSpect” in Chapter 4 for more 

information.

The Center will notify Program Division as soon as a case (compliance) officer has been 

assigned. This early communication will create opportunities to discuss the case, 

including the overall strategy, as well as the history, violations, rationale, charging 

scheme, regulatory and policy considerations, local knowledge, and national/program 

issues. 

If, after its initial review of a Program Division's recommendation, the Center compliance 

unit is inclined not to concur with the Division's recommendation, the Center will 

promptly notify and provide the Division with an oral explanation for its preliminary 

decision not to concur with the recommendation. If the Division does not agree with the 

basis for the potential disapproval, it should provide the Center with additional 

justification for proceeding with the recommended action within three business days. 

The additional justification should be limited to information currently available to the 

Division, not a commitment to gather additional information to support the 
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recommendation. The Center will consider this additional justification before making a 

final disposition on the Division's recommendation, apprise the Division of its decision, 

and prepare the final memo. The Center's final disposition on the recommendation 

(approved or disapproved) will normally not be delayed if it is determined that an 

inspection will be necessary to collect additional supporting evidence. The involved 

compliance officer and the appropriate division should participate in discussions with the 

Center that occur during the process described in this paragraph. If the official action 

proposed was not the subject of a formal recommendation from the Division (e.g. BIMO, 

foreign inspection), the same communication principles should apply between involved 

Center and Division staff. 

10-1-2 Regulatory Actions prepared by a Center for Program Issuance and/or 

Follow-up

When a decision is made by a Center that a Program Division issuance, involvement 

and/or follow-up is an appropriate course of action, the Center should notify the 

appropriate Division compliance unit(s) regarding its intent to prepare a regulatory 

action, and provide the Division(s) with an opportunity to collaborate on the compliance 

strategy and the substance of the action.

10-1-3 Debarment - Notification Responsibilities of FDA Employees 

1. Background

a. Purpose and Authority for Debarment - Debarment is a remedial 

measure taken under section 306 of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) to prohibit a person (e.g., an individual, 

corporation, partnership, or association) from participating in FDAregulated activities, as described below:

i. A person other than an individual may be prohibited from 

submitting, or assisting in the submission of, any abbreviated 

drug application. Sections 306(a)(1) and 306(b)(1)(A).

ii. An individual may be prohibited from providing services in any 

capacity to the sponsor of an approved or pending drug product 

application. Sections 306(a)(2) and 306(b)(1)(B).

iii. A person may be prohibited from importing an article of food, or 

offering an article of food for import, into the United States. 

Section 306(b)(1)(C).

iv. A person may be prohibited from importing or offering for import 

into the United States any drug. 306(b)(1)(D)
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v. A person may be prohibited from being accredited to inspect 

eligible device manufacturers and from carrying out activities 

under agreements with foreign countries to facilitate commerce 

in devices. Section 306(m)(1).

Debarment may be based on a criminal conviction or on conduct, as 

identified in section 306 of the Act. See Persons Subject to Debarment

in paragraph 3 in this subsection.

b. “Drug Product” - For purposes of section 306, the term “drug product” 

means a drug subject to regulation under section 505 (new drugs), 

section 512 (new animal drugs), or section 802 (exports of certain 

unapproved products) of the Act, or under section 351 (regulation of 

biological products) of the Public Health Service Act. Section 201(dd).

c. Other Possible Actions - Civil Penalties

d. Under section 307(a)(6) of the Act, any person with an approved or 

pending drug product application who knowingly engages the services 

of a debarred person is liable for civil penalties.

e. Under 307(a)(7), debarred individuals are subject to civil penalties for 

providing services to a person with an approved or pending drug 

product application.

2. Notification Responsibilities

a. Authority - Staff Manual Guide (SMG) 7712 - Debarment Proceedings

provides general procedures for FDA staff to follow for debarment 

actions and defines the responsibilities of FDA employees. ORA’s 

Division of Enforcement (DE) has responsibility for initiating and 

pursuing debarment actions. All FDA employees have a responsibility 

to notify DE of any persons that may be subject to debarment and to 

forward relevant materials to DE within specified timeframes, as 

detailed below. 

b. Required Notification - In accordance with SMG 7712, all FDA 

employees have the following responsibilities: 

i. Ensuring that ORA’s Division of Enforcement (DE) is notified 

when the employee observes conduct or has notice (from an 

oral or written communication) that a person may be subject to 

debarment.

ii. Ensuring that DE is provided with copies of all relevant materials 

(e.g., any written notice or petition for debarment and 
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information supporting debarment) in the employee’s 

possession.

Send the notification and materials to the attention of the Debarment 

Specialist, DE via electronic transmission, interoffice or regular mail, or 

FAX. Include your name, office, and phone number. The debarment 

specialist can be reached at debarments@fda.hhs.gov or 

240-402-8743. Contact the debarment specialist if you have any 

questions about notification or debarment, or if you need further 

information.

c. Timeframes for Notification - If the person who may be subject to 

debarment:

i. has an approved or pending drug application;

ii. is an employee of such a person;

iii. is a clinical investigator; 

iv. is currently engaged in importing food or offering it for import; or

v. is currently engaged in importing a drug or offering it for import; 

or

vi. has been convicted of a felony under section 301(gg) of the Act,

FDA employees will notify DE as soon as is practicable. Otherwise, 

employees will notify DE within ninety (90) days of receiving the oral or 

written notice.

d. Requirements Applicable to OCI - The Office of Criminal Investigations 

(OCI) is responsible for providing quarterly reports to the DE that set 

forth all convictions that have occurred within the preceding three (3) 

months that may trigger debarment.

3. Persons Subject to Debarment

The triggering event for debarment is ordinarily a felony or misdemeanor 

conviction under Federal law or a felony conviction under State law. 

However, certain conduct may subject a food or drug importer, and, for 

drugs and biologics, a high managerial agent (and other individuals) to 

debarment. The types of convictions and conduct that may subject 

persons to debarment are detailed in section 306 of the Act and 

summarized below, by product type.
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a. Foods: A person (an individual, corporation, partnership, or 

association) is subject to debarment if the person has been convicted 

of a felony for conduct relating to the importation into the U.S. of any 

food, or has engaged in a pattern of importing or offering for import 

adulterated food that presents a threat of serious adverse health 

consequences or death to humans or animals. Section 306(b)(3).

b. Drug Imports: A person (an individual, corporation, partnership, or 

association) is subject to debarment if the person has been convicted 

of a felony for conduct relating to the importation into the U.S. of any 

drug or controlled substance (as defined in section 102 of the 

Controlled Substances Act [21 USCS § 802]), or has engaged in a 

pattern of importing or offering for import, (i) controlled substances that 

are prohibited from importation under section 401 (m) of the Tariff Act 

of 1930 (19 U.S.C. 1201(m)) or, (ii) adulterated or misbranded drugs 

that are (I) not designated in an authorized electronic data interchange 

system as a product that is regulated by the Secretary or (II) knowingly 

or intentionally falsely designated in an authorized electronic data 

interchange system as a product that is regulated by the Secretary. 

Section 306(b)(3).

c. Drugs (Drugs Applications) – Corporations, Partnerships, and 

Associations: A person other than an individual is subject to 

debarment if that person has been:

i. Convicted of a felony under Federal law for conduct relating to 

the development or approval, including the process for 

development or approval, of any abbreviated drug application. 

Section 306(a)(1).

ii. Convicted for conduct that relates to the development or 

approval, including the process for development or approval, of 

any abbreviated drug application, and is a misdemeanor under 

Federal law or a felony under State law. Section 306(b)(2)(A)(i). 

iii. Convicted of a conspiracy to commit, or aiding or abetting, a 

criminal offense described in i. or ii. above. Section 

306(b)(2)(A)(ii). 

d. Drugs/Biologics (Drug Applications) – Individuals: An individual is 

subject to debarment if s/he has been:

i. Convicted of a felony under Federal law for conduct relating to 

the development or approval, including the process for 

development or approval, of any drug product, or otherwise 
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relating to the regulation of any drug product under the Act. 

Section 306(a)(2).

ii. Convicted of a misdemeanor under Federal law or a felony 

under State law for conduct relating to the development or 

approval, including the process for development or approval, of 

any drug product, or otherwise relating to the regulation of drug 

products under the Act, or has been convicted of a conspiracy 

to commit, or aiding or abetting, a criminal offense described in 

this paragraph or the preceding paragraph. Section

306(b)(2)(B)(i).

iii. Convicted of a felony under Federal law or a felony under State 

law which involves bribery, payment of illegal gratuities, fraud, 

perjury, false statement, racketeering, blackmail, extortion, 

falsification or destruction of records, or interference with,

obstruction of an investigation into, or prosecution of, any 

criminal offense, or a conspiracy to commit, or aiding or 

abetting, such felony. Section 306(b)(2)(B)(ii).

e. Drugs/Biologics (Drug Applications) – Debarment based on Conduct: 

An individual is also subject to debarment:

i. If s/he materially participated in acts that were the basis for a 

conviction for an offense subject to debarment. Section 

306(b)(2)(B)(iii).

ii. If s/he is a high managerial agent who:

• worked for, or worked as a consultant for, the same person as 

another individual during the period in which such other 

individual took actions for which a felony conviction was 

obtained and which resulted in the debarment of such individual; 

• had actual knowledge of the actions described above of such 

other individual, or took action to avoid such actual knowledge, 

or failed to take action for the purpose of avoiding such actual 

knowledge; 

• knew that the actions were violative of law; and 

• did not report such actions, or did not cause such actions to be 

reported, to an officer, employee, or agent of the Department or 

to an appropriate law enforcement officer, or failed to take other 

appropriate action that would have ensured that the process for 

the regulation of drugs was not undermined, within a reasonable 
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time after such agent first knew of such actions. Sections 

201(bb) and (cc), and 306(b)(2)(B)(iv).

f. Devices: A person (an individual, corporation, partnership, or 

association) accredited to inspect eligible device manufacturers is 

subject to debarment if the person has been convicted of a felony for 

one or more prohibited acts under section 301(gg) of the Act. Section 

306(m).

Section 301(gg) prohibits the knowing failure to notify the Secretary of a 

condition the accredited person discovered during an inspection that could 

cause or contribute to an unreasonable risk to the public health as 

required by section 704(g)(7)(E), or an accredited person’s knowing 

inclusion of false information in an inspection report prepared under 

section 704(g)(7)(A), or the knowing failure to include material facts in 

such a report.

10-2 PRIOR NOTICE

10-2-1 Purpose

This section defines "prior notice" and establishes uniform criteria to determine if 

adequate prior notice has been provided.

10-2-2 Background

Except in a few specifically defined areas, the Food and Drug Administration (FDA) has 

no legal obligation to warn firms or individuals that they, their practices, or their products 

are in violation of the law prior to taking formal enforcement action. However, a basic 

principle of FDA’s enforcement policy is the belief that the majority of persons will 

voluntarily comply with the law when given information as to what is required, what 

violations appear to exist, and, in the case of violations of regulatory significance, that 

failure to comply may result in the initiation of enforcement action.

10-2-3 Prior Notice 

When it is consistent with the public protection responsibilities of the agency and if a 

violative situation does not present a danger to health or does not constitute intentional, 

gross or flagrant violations, it is FDA’s practice to afford individuals and firms an 

opportunity to voluntarily take appropriate and prompt corrective action prior to the 

initiation of enforcement action. If voluntary correction is not achieved, documentation 

that adequate prior notice was provided strengthens the agency's position in 

enforcement actions by establishing that responsible individuals continued violating the 

law despite having been warned by the agency.
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The following factors should be considered in evaluating the adequacy of prior notice 

(prior warning):

1. The conduct, condition, practice, or product violates the laws enforced by FDA. 

2. The notice (warning) adequately identified the violative conduct, condition, 

practice or product. 

Note: Similar violations do not need separate prior notices, for example, separate 

prior notices are not necessary for each unapproved new drug shipped. 

3. Notice (warning) was provided to the firm and the most responsible individuals. 

4. The firm was afforded a reasonable amount of time to implement corrections. 

Corrections may include halting shipments, recalling product in violation, or 

changing procedures and controls. 

5. Consider if situations have occurred that may affect the adequacy of prior notice, 

such as a change in ownership or responsible management. For example, 

consider what is known by the new management, and if the "firm" received 

notice. 

Note: Prior Notice may be provided orally or in writing. Where there is no dispute as to 

what is required to comply with the law, adequate notice may well be the Investigator’s 

discussion of objectionable conditions with responsible management at the conclusion 

of the inspection. If, however, the violative conduct involves a controversial area, an 

area in which policy is still emerging, or one that has not been pervasively regulated in 

the past, written notice (usually in the form of a Warning Letter) may be required prior to 

the initiation of enforcement action.

Consideration of these factors will facilitate meeting the prior notice requirements for 

civil and certain criminal actions.

10-2-4 Procedures

Warning Letters are the principal means by which the agency provides prior notice of 

violations and of achieving voluntary compliance. See RPM Chapter 4, Advisory 

Actions. However, Prior Notice may be provided by means of a civil suit, administrative 

action, or other less formal ways, including the following:

1. Enforcement action or notification by State, municipal or other Federal agencies 

involving the same or similar violations. 

2. Issuance of the FDA-483, List of Observations, at the conclusion of an 

inspection. Issuance of a copy of the FDA-483 to a firm's most responsible 

person(s) must follow guidance in IOM Chapter 5 – Establishment Inspections. 
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3. Discussion with management by an FDA investigator, documented in the EIR. 

4. Recall Classification Notification Letters. 

5. Properly documented meetings or telephone conversations between agency 

officials and a firm's top management (see section 10-3, Regulatory Meetings). 

6. Properly documented advisory communications by FDA Center personnel 

concerning critical scientific issues. 

Note: For further information related to "properly documented" telephone conversations 

and meetings, see SMG 2126.2, Memoranda of Telephone Conversations and 

Meetings with Non-FDA Persons.

10-3 REGULATORY MEETINGS

A Regulatory Meeting is a meeting requested by FDA management at its discretion, to 

inform responsible individuals or firms about how one or more products, practices, 

processes, or other activities are considered to be in violation of the law. FDA is not 

required to hold a Regulatory Meeting and, except for a few specifically defined areas 

(see RPM Chapter 4, Advisory Actions > Warning Letter Procedures), is not required to 

provide any other form of prior notice prior to taking an enforcement action.

Regulatory Meetings can be an effective enforcement tool to obtain prompt voluntary 

compliance, and have been used successfully in a variety of different situations, 

including:

1. As a follow-up to a Warning Letter when firms have corrected the majority of 

violative conditions noted in the Warning Letter, to provide additional 

encouragement, direction, and assistance in achieving compliance. As a followup to a Warning Letter, FDA officials may remind a firm or individual in a 

Regulatory Meeting that failure to make appropriate corrections in a timely 

manner may result in enforcement action. 

2. To communicate documented violations that do not warrant the issuance of a 

Warning Letter. Under these circumstances, a Regulatory Meeting provides the 

added benefit of real time, two-way discussion of the violations and the 

appropriate corrective actions.

A Regulatory Meeting should not be used as a substitute for an Untitled Letter when a 

particular compliance program calls for the issuance of an Untitled Letter. Also, in most 

cases, a Regulatory Meeting should not be used to initially communicate violations of 

regulatory significance. Such violations are generally best communicated in the form of 

a Warning Letter. However, there are some situations when a regulatory meeting may 

be used to initially communicate violations of regulatory significance. Examples include:
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1. When a Regulatory Meeting is held to communicate a health hazard and the 

necessity for immediate corrective action to address violative product that is on 

the market. 

2. When a Regulatory Meeting is held in conjunction with the issuance of a Warning 

Letter to emphasize the significance of the violations. 

A successful outcome of a Regulatory Meeting would include a commitment by the 

responsible individuals to correct the conditions or practices at their facility that are in 

violation of the law. The divisions, at their discretion, would typically verify these 

commitments through evaluation of subsequent communication and documentation 

and/or a follow-up inspection. The inspection classification should reflect the 

significance of the violations and can be appropriately modified based on the adequacy 

of the corrective action. In those instances where the corrective actions are not 

satisfactorily carried out, definitive plans should be made for follow up action by the 

Division. Consult with the involved Center and DE is advisable.

Any FDA organization with regulatory oversight of a firm or individual has the discretion 

to decide whether or not to hold a Regulatory Meeting. If a Center decides to hold a 

Regulatory Meeting concerning observations made by one or more Divisions, the 

Center should invite any -ORA DE staff involved and consider any objections that such 

division(s) may have to such meeting. Centers are also encouraged to invite division

participation in Regulatory Meetings concerning observations or matters originating in 

the Center (e.g., unapproved new drug or device issues). Any disagreement between a 

Center and a Division about whether to conduct a Regulatory Meeting should be 

resolved by collaborative discussion with the Center, Division, and DE.

For situations that involve corporate-wide violations or multiple divisions, the meeting 

should include the affected Centers, DE, and the involved Divisions. The location of the 

meeting should be negotiated by the involved parties.

Summary minutes must be prepared for all regulatory meetings.

10-4 INSPECTION OF FOOD RECORDS – SECTIONS 414(a) and 

704(a)

10-4-1 Purpose

This section describes the authority, criteria, and procedure for inspecting records under 

sections 414(a) and 704(a) of the FD&C Act.

10-4-2 Authority

1. The FD&C Act:
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a. Section 414(a) Records Inspection – Criteria for records access, see 

subsection 10-4-3 below.

b. Section 414(b)- Authority to issue regulations to establish requirements 

for the establishment and maintenance of records needed to determine 

the immediate previous sources and the immediate subsequent 

recipients of food. See 21 CFR 1.326 to 1.368.

c. Section 414(c)- Protection of sensitive information. FDA shall take 

appropriate measures to ensure that effective procedures are in place 

to prevent the unauthorized disclosure of any trade secret or 

confidential information that is obtained by FDA pursuant to section 

414.

d. Section 414(d) Limitations- This section shall not be construed -- (1) to 

limit the authority of FDA to inspect records or require establishment 

and maintenance of records under any other provision of this Act; (2) 

to authorize FDA to impose any requirements with respect to a food to 

the extent that it is within the exclusive jurisdiction of the Secretary of 

Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 

et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or 

the Egg Products Inspection Act (21 U.S.C. 1031 et seq); (3) to have 

any legal effect on section 552 of title 5, United States Code, or section 

1905 of title 18, United States Code; or (4) to extend to recipes for 

food, financial data, pricing data, personnel data, research data, or 

sales data (other than shipment data regarding sales).

e. Section 704(a)(1)(B)- Requirement that, during an inspection, any 

person (excluding farms and restaurants) who manufacturers, 

processes, packs, transports, distributes, holds, or imports foods 

provide access to all records and other information described in 

section 414, when the criteria for records inspection in section 

414(a)(1) or (a)(2) are satisfied, subject to the limitations in section 

414(d).

f. Section 301(e)- Authority to treat the refusal to permit access to or 

copying of any record required by section 414 or 704(a) or the failure 

to establish or maintain any record required by section 414(b) as 

prohibited acts.

2. 21 CFR 1.361: What are the Record Availability Requirements?

When FDA has a reasonable belief that an article of food, and any other 

article that FDA reasonably believes is likely to be affected in a similar 

manner, is adulterated and presents a threat of serious adverse health 

consequences or death to humans or animals (SAHCODHA), or when 
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FDA believes that there is a reasonable probability that the use of or 

exposure to an article of food, and any other article of food that the FDA 

reasonably believes is likely to be affected in a similar manner, will cause 

SAHCODHA, any records and other information accessible to FDA under 

section 414 or 704(a) of the FD&C Act must be made readily available for 

inspection and photocopying or other means of reproduction. Such 

records and other information must be made available as soon as 

possible, not to exceed 24 hours from the time of receipt of the request.

10-4-3 Statutory requirements for invoking records inspection authority

FDA can invoke its authority to access and copy records when the statutory 

requirements in section 414(a)(1), 414(a)(2), or section 704 of the FD&C Act are 

satisfied, whether or not intentional adulteration is known or suspected.

1. Section 414(a)(1) Adulterated Food

If FDA has a reasonable belief that an article of food, and any other article of 

food that FDA reasonably believes is likely to be affected in a similar manner, is 

adulterated and presents a threat of serious adverse health consequences or 

death to humans or animals, FDA has authority to access and copy all records 

relating to such articles that are needed to assist FDA in making this 

determination.

2. Section 414(a)(2) Use of or Exposure to Food of Concern

If FDA believes that there is a reasonable probability that the use of or exposure 

to an article of food, and any other article of food that FDA reasonably believes is 

likely to be affected in a similar manner, will cause serious adverse health 

consequences or death to humans or animals, FDA has authority to access and 

copy all records relating to such article, and any other article of food that FDA 

reasonably believes is likely to be affected in a similar manner, that are needed 

to assist FDA in making this determination.

Sections 414(a)(1) and 414(a)(2) apply to any person - excluding farms and restaurants 

- who manufactures, processes, packs, distributes, receives, holds, or imports such 

article of food. Appropriate credentials and a written notice must be presented and the 

request for records must be conducted at reasonable times, within reasonable limits, 

and in a reasonable manner. See 10-4-7.

For foreign firms, section 414 applies to any person (excluding farms and restaurants) 

who manufactures, processes, packs, transports, distributes, holds, or imports such 

article intended for U.S. commerce.
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10-4-4 Records that may be accessed and copied under this authority

FDA may access and copy all records, as authorized under section 414 and 704 

relating to the manufacture, processing, packing, distribution, receipt, holding, or 

importation of the article of food that are maintained by or on behalf of an entity in any 

format (including paper and electronic formats) and at any location, which are needed to 

meet the criteria in section 414(a)(1) or (a)(2). See 21 CFR 1.326.

The Investigator should initially request and review the records most likely needed to 

establish adulteration and serious adverse health consequences or death to humans or 

animals. See sections 414(a)(1) and (a)(2). The Investigator, as appropriate, should 

extend the review to other necessary records.

10-4-5 Records that may not be accessed and copied under this authority

FDA's authority under sections 414 and 704(a) of the FD&C Act does not apply to: 

recipes for food, financial data, pricing data, personnel data, research data (except test 

marketing a food), or sales data (other than shipment data regarding sales), all of which 

are excluded under section 414(d). In addition, FDA may not access records from farms 

and restaurants. See 21 CFR 1.362.

In 21 CFR 1.328, "recipe" is defined as “the formula, including ingredients, quantities, 

and instructions necessary to manufacture a food product. Because a recipe must have 

all three elements, a list of the ingredients used to manufacture a product without 

quantity information and manufacturing instructions is not a recipe." Accordingly, FDA 

has authority to access such a list of ingredients in a records request.

10-4-6 Procedure for Invoking Records Inspection Authority

The Program Division must obtain ORA/Division of Enforcement (DE) concurrence in 

accordance with the procedures below before making a request to any person for 

access to records under sections 414(a) and 704(a). The procedure should be 

expedited and be initiated upon receiving the firm’s refusal. The final determination to 

invoke this authority should occur within 24 hours of initiating this procedure.

1. FDA's Office of Emergency Operations (OEO) will coordinate activities to obtain 

ORA/DE concurrence on a records request and should be initially contacted as 

follows:

a. During a domestic inspection, Program Division or other FDA 

personnel notifies FDA's OEO at 866-300-4374 or 301-796-8240; or 

via email at Emergency.Operations@fda.hhs.gov – 24 hours/day. OEO 

may be contacted in advance of an inspection if the refusal of records 

is likely.
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b. During a foreign inspection, the FDA investigator conducting the 

inspection notifies the Division of Foreign Human and Animal Food 

Operations (DFHAFO) for guidance. DFHAFO then notifies OEO.

2. OEO notifies the appropriate Center (CFSAN and/or CVM) and ORA/DE either 

verbally or in writing.

3. OEO schedules a conference call with the Program Division, appropriate Center 

compliance unit, ORA/DE, and the Office of Chief Counsel (OCC). Prior to the 

conference call, the Program Division should prepare a draft recommendation 

memorandum (Exhibit 10-1) and a draft Form FDA 482c for OEO to distribute to 

call participants on the call. During the conference call:

a. The Program Division must be prepared to address the following:

• Rationale for why there is a reasonable belief regarding an article of 

food as required by section 414(a)(1) and/or a reasonable 

probability regarding an article of food as required by section 

414(a)(2) of the FD&C Act;

• Details surrounding record refusal, including the reason for refusal 

and FDA’s attempts at obtaining necessary records;

• Date/s of the inspection;

• List of records to be requested and rationale for why the records 

meet the statutory requirements of section 414 of the FD&C Act; 

and 

• Approximate timeframe for when the Form FDA 482c could be 

issued, if approved, and any concerns surrounding issuance.

b. The appropriate Center, with the concurrence of ORA/DE, determines 

that there is a reasonable belief that the food is adulterated and 

presents a threat of SAHCODHA, or that there is a reasonable 

probability that the use of or exposure to the food will cause 

SAHCODHA.

c. ORA/DE concurs with any requests for access to records, and works 

with the appropriate Center to determine the scope of the request and 

ensures the requested records are necessary to assess whether the 

food, and any other food that FDA reasonably believes is likely to be 

affected in a similar manner, is adulterated and presents a threat of 

SAHCODHA or whether there is a reasonable probability that the use 

of or exposure to the food, and any other food that FDA reasonably 

believes is likely to be affected in a similar manner, will cause 

SAHCODHA.
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d. The appropriate Center consults with OCC on the determination of 

whether there is a reasonable belief that the food is adulterated. 

ORA/DE will consult with the appropriate Center and OCC in 

determining the appropriate scope of the records request.

4. After concurrence has been reached on the call from ORA/DE, the Center, and 

OCC, the Program Division finalizes the recommendation memorandum (Exhibit 

10-1) and forwards it to the Center for final concurrence. OEO prepares a record 

of the call and distributes the record to the participants on the call.

5. The delegated official from the Center signs the final determination (Exhibit 10-1). 

See SMG 1410.306, Determinations Related to Records Access for Human 

and Animal Foods under Section 414 of the Federal Food, Drug, and 

Cosmetic Act, for delegations of authority.

6. Once the final determination is signed by the Center, the Center provides the 

signed memorandum to ORA/DE. ORA/DE conveys the information to the 

Program Division Director for the facility being inspected (domestic inspection) or 

DFHAFO (foreign inspection). If it is a foreign inspection, DFHAFO conveys the 

information to the appropriate foreign inspection investigator.

7. The Program Division maintains the case documentation in CMS, including a 

record of concurrence by each office. For foreign inspections, the Center is 

responsible for managing the case in CMS. Once the 482c is issued, the case 

may be closed. The case may be withdrawn if the decision is made to not pursue 

the records request.

10-4-7 Issuing Form FDA 482c

After the necessary determination has been made in accordance with the procedures in 

section 10-4-6 above, an investigator or other authorized FDA personnel upon 

presentation of credentials will issue a written notice, Form FDA 482c, to the owner, 

operator, or agent in charge, informing that person of the records requested and FDA's 

legal authority to obtain such records. The Form FDA 482c and the related procedures 

are described in the Investigations Operations Manual (IOM) Chapter 5 - Establishment 

Inspections Subchapter 5.4 - Food. FDA may request additional records related to the 

implicated food at a later time under the same authority. For foreign inspections, consult 

with OCC.

10-4-8 Timeframes for compliance

For all persons except foreign firms, records and other information requested under this 

authority must be made available as soon as possible, not to exceed 24 hours from the 

time of receipt of the request. 21 CFR 1.361. The Division should document in CMS the 

outcome and the firm’s compliance with request.
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10-4-9 Failure to provide records

The refusal to permit access to or copying of any record required by section 414 or 

704(a) and the failure to establish or maintain any record required by section 414(b) are 

prohibited acts under section 301(e) of the Act. See 21 CFR 1.363.

10-5 ESTABLISHMENT INSPECTION REPORT (EIR) CONCLUSIONS 

AND DECISIONS

For further information, see Field Management Directive (FMD) No. 86 Establishment 

Inspection Report Conclusions and Decisions, or refer to the FDA’s FMD web site.

Please remember to update the firm’s profile information at each stage in the review 

process to its conclusion, as appropriate, for any Current Good Manufacturing Practice 

(CGMP) or Quality System (QS) inspection of a domestic or foreign drug, biologics, 

medical device or combination product facility that involves compliance activity or 

status. See “Firm Profile Updates in eNSpect” in RPM Chapter 4 for further information.

10-5-1 Release of the Establishment Inspection Report

For further information on the criteria and instructions for releasing one copy of an 

Establishment Inspection Report, to the firm’s top management or designee at the 

inspected firm, see Field Management Directive No.145 Release of the Establishment 

Report.

10-5-2 No Action Indicated (NAI) and Voluntary Action Indicated (VAI) 90 day 

Decisional Letters for Drug Inspections

For further information on the criteria and instructions for the new NAI and VAI 90 Day 

Decisional Letters, see Field Bulletin No.63 - FMD-145 NAI/VAI 90 Day Decisional 

Letters for Drug Inspections

10-6 INTERSTATE TRAVEL PROGRAM (ITP) CLASSIFICATIONS AND 

ADMINISTRATIVE ACTIONS

For further information related to ITP see Compliance Program 7318.029, Interstate 

Travel Program-- Conveyances and Support Facilities.

10-7 REPORTING AND MONITORING

The Field Accomplishments and Compliance Tracking System (FACTS) replaces this 

section. Please see your FACTS Lead User for further guidance.
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10-8 AD HOC COMMITTEE

10-8-1 Purpose

This section outlines the function, composition, and activities of agency ad hoc

committees that are convened for enforcement purposes, and lists the responsibilities of 

the field and headquarters units in recommending and carrying out their goals.

10-8-2 Function

There are four principle types of ad hoc committees: “strategy,” “referral,” “appeal,” and

“seizure/injunction.”

1. Strategy ad hoc committees are formed to resolve issues for which agency 

precedent is lacking on matters that involve complex and difficult enforcement 

issues, or where there is a dispute between two or more offices over strategy.

2. Referral ad hoc committees are formed to consider the referral of a matter to the

Department of Justice for further criminal investigations or proceedings. See 

RPM Chapter 6, “Judicial Actions.”

Note: OCI is responsible for reviewing all matters within FDA’s jurisdiction for 

which a criminal investigation may be recommended. If the division or center 

office believes that there is a need for a criminal investigation, they must contact 

OCI immediately. If OCI concludes that they will not be participating in the matter 

at the time, the division office or center may then proceed as outlined below

under 10-8-4 Procedures.

3. Appeal ad hoc committees are formed to resolve issues pertaining to a legal, 

administrative, or regulatory course of action, when enforcement policy is 

inconsistent, unclear or not fully developed.

4. Seizure/injunction ad hoc committees may be convened at any time during the 

preliminary assessment, case initiation, or concurrent review process (see RPM 

Chapter 6) when ORA, the Center Director, or the Deputy Chief Counsel for 

Litigation, or a designee, cannot agree on the strategy or viability of a seizure or 

injunction case.

Ad hoc committees may be formed at any point in the case development or review 

process; however, early identification of the need for an ad hoc committee enables a 

more prompt review of the action.

10-8-3 Composition

The ad hoc committee will be chaired by the Director, DE, and will consist of the 

appropriate directors of Program Office involved and of the center office of compliance, 
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the Deputy Chief Counsel for Litigation and, if appropriate, the Director, OCI. The 

Director, OEIO, should be included when the matter involves a foreign inspection. When 

a committee member is unable to participate in a scheduled ad hoc meeting, he or she 

must designate an appropriate official to serve in his or her absence.

The committee members or their designated representatives should be prepared to 

make agency decisions on the issues based upon the evidence presented prior to and 

during the ad hoc committee meeting. The committee members are also responsible for 

identifying and arranging for the participation of any additional personnel and for other 

resources that they feel are necessary. Personnel should be limited to those individuals 

who have knowledge of the events at issue or who can significantly help in the decision 

making process.

10-8-4 Procedures

Requests for forming a strategy, referral, appeal, or seizure/injunction ad hoc committee 

may originate from an appropriate division director and program office director, DE; a 

Director of Compliance; or the Deputy Chief Counsel for Litigation.

If the parties cannot reach an agreement working on their own or with the help of DE, 

DE will schedule an ad hoc committee meeting.

The person who requests an ad hoc committee must submit a memorandum via CMS to 

DE, OSPOP. The memorandum should specify the type of ad hoc committee being 

requested.

a. The person who requests a strategy ad hoc committee should include 

in the memorandum the recommended outcome of the meeting.

b. The person who requests a referral ad hoc committee should include in 

the memorandum a description of the evidence expected to be gained 

through further criminal investigations or proceedings and the reasons 

it is necessary to refer the matter to the Department of Justice instead 

of continuing with an FDA investigation.

c. The person who requests an appeal ad hoc committee does not need 

to summarize the facts and evidence in the memorandum if the 

committee participants are already familiar with the case; however, if 

the committee participants are unfamiliar with the case, the person 

who requests an appeal ad hoc should include sufficient background 

and supporting information in the memorandum.

d. The person who requests a seizure/injunction ad hoc committee 

should describe any disputed data, information, or views in the 

memorandum. When an ad hoc committee is requested, the clock for 

reviewing seizure/injunction cases will be tolled. Therefore, the time it 
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takes to review the ad hoc request will not be applied against the 

timelines for reviewing seizure/injunction cases, described in section 6-

1-5 (4). The ad hoc committee will immediately establish a time 

schedule for its review of the case.

At the ad hoc committee meeting, the person who requested the meeting will briefly 

summarize the reason for the request, recommend an outcome of the meeting, describe 

any foreseeable problems, and provide whatever information may be useful in reaching 

a decision.

All decisions made by the ad hoc committee, including necessary follow-up and 

strategy, will be recorded, disseminated, and noted in the appropriate section of CMS 

by the Compliance Officer assigned to the case.

The ad hoc committee may reconvene in cases of significant changes, or revisions to 

the original ad hoc supporting material, the discovery of new information or evidence, or 

when other issues arise that could impact the original decision of the committee. These 

changes must first be reviewed under the regular review process. If it is necessary to 

reconvene the ad hoc committee, the original ad hoc attendees should make every 

effort to attend any follow-up ad hoc meeting.

In most instances, the committee will reach a decision through consensus of the 

members. When consensus is not possible, the Director, DE will refer the matter to the 

Associate Commissioner for Regulatory Affairs (ACRA) with a recommendation for 

making a final decision.

All committee decisions are subject to review by the ACRA and OCC, and the final 

decision will not be subject to appeal.

10-8-5 Responsibilities

DE receives the request for convening an ad hoc committee review. DE assesses the 

request to determine if there is a clear indication of a dispute or other issue in need of 

resolution, determines whether sufficient information was submitted, attempts to obtain 

a resolution with the parties, and if a resolution cannot be reached, establishes the time 

and place for the meeting. DE will also disseminate the request and any supporting 

material to the principal members of the ad hoc committee.

The Director, DE, chairs the ad hoc committee and issues the final decision based upon 

the ad hoc committee’s discussion. If the ad hoc committee cannot reach a decision, the 

Director, DE, refers the matter to the ACRA for a final decision.

The Director, ORO, may recommend convening an ad hoc committee based on issues 

that arise from ORO headquarters based program activities.
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The appropriate division directors listed in subsection 10-8-3 Composition make a final 

decision on all recommendations for an ad hoc committee from the field. The Regional 

Director serves as a principal on the ad hoc committee.

The Division Director may recommend the convening of an ad hoc committee and 

forward the recommendation to DE through the appropriate division directors listed in 

subsection 10-8-3.

The Director of Compliance of the appropriate Center approves or disapproves all 

recommendations for an ad hoc committee from the center and will serve as a principal 

on the ad hoc committee.

The Deputy Chief Counsel for Litigation will serve as a principal on the ad hoc

committee to provide legal counsel, and to advise on a particular recommendation.

The ACRA may review all committee decisions.

Committee members who are unable to participate in a scheduled ad hoc meeting are 

responsible for designating an appropriate official to serve in their absence. The 

committee members are also responsible for identifying and arranging for the 

participation of any appropriate resource persons they feel are necessary, and for 

providing necessary background information to those persons.

10-9 APPEAL PROCESS

10-9-1 Purpose

This section sets forth a procedure for the appeal of decisions regarding 

recommendations for legal or administrative actions.

10-9-2 Who May Appeal

Appeals may be originated by the appropriate division directors listed in subsection 10-

8-3 or the Center Directors for Compliance (or equivalent).

10-9-3 What May Be Appealed

Appropriate officials may appeal any decision disapproving a proposed action, 

administrative or legal, which is allegedly inconsistent, or where there is nonexistent 

enforcement policy. The directors of the involved offices must have attempted to resolve 

the disagreement prior to submitting an appeal.

10-9-4 When An Appeal Is Not Appropriate

An appeal is not appropriate when additional information that overcomes the basis for 

the original denial becomes available. In such cases, the recommendation should be 
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updated to include the new or additional information and resubmitted to the reviewing 

office with an explanation for the resubmission and a request for reconsideration.

10-9-5 Requests For Appeal

ORA should submit appeals over the signature of the appropriate division directors 

listed in subsection 10-8-3. Centers should submit appeals over the signature of the 

Center Director for Compliance. The appeal memorandum and two copies of relevant 

supporting material must be identified, indexed, and submitted to the Director, DE.

The appeal memorandum must identify the issues on which the appeal is based, and 

the reasons for disagreeing with the decision of the declining unit. Recommendations 

must include a summary of communications regarding attempts to resolve differences of 

opinion.

10-9-6 Review Of Appeals

DE will review the appeal package to assure that it is complete, determine that an 

appeal is appropriate, and will determine whether the appeal deals with policy, 

regulations, or a statute. DE will initially attempt to gain a resolution of the disagreement 

by the parties to the appeal.

10-9-7 Decision On Appeals

If DE cannot get the parties to agree, an ad hoc committee meeting to be chaired by the 

Director, DE, will be scheduled, following the procedures outlined in section 10-6, ad 

hoc Committee.

The meeting will include the appropriate division directors listed in subsection 10-8-3, 

the Center Director for Compliance, and the Deputy Chief Counsel for Litigation, if 

appropriate. If the principals are unable to attend, they will designate a senior 

compliance official to serve in their absence. Usually only one resource person must 

accompany the senior compliance official.

Resolution of appeals is by consensus of the ad hoc committee members. If the ad hoc

committee can not reach a consensus, the matter will be forwarded to the ACRA for a 

final decision.

Decisions made by the ad hoc committee will be recorded and distributed to meeting 

participants. The decision may be limited to a decision on the merits of the case or it 

may include instructions to develop policy in a particular program area. The ACRA or 

OCC may review all committee decisions.
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10-10 EXPERT SUPPORT FOR CASES

10-10-1Purpose

This section sets out a procedure for assuring that medical, scientific, technical or other 

specialized (collectively “expert”) support is available for a case. A witness qualified as 

an expert by knowledge, skill, experience, training or education, may testify thereto in 

the form of an opinion or otherwise, if 

1. the testimony is based upon sufficient facts or data, 

2. the testimony is the product of reliable principles and methods, and 

3. the witness has applied the principles and methods reliably to the facts of the 

case.

Federal Rules of Evidence, “Rule 702. Testimony by Experts”.

For purposes of this section, the term “case” refers to a matter that is or may become a 

court case or hearing. The term “experts” is used to describe individuals from within or 

outside of FDA, who may serve as consultants and/or as expert witnesses in a case. 

FDA may seek expert support whether or not a case is contested or litigated.

10-10-2Responsibility

The Centers have the primary responsibility for assuring that FDA has appropriate 

expert support for a case, if needed to support the particular violation. The initial 

determination as to the need for expert support shall be included in the approval 

memorandum. The Center Compliance Office, in consultation with OCC, should 

determine whether or not FDA needs expert support for a case. If the Center 

determines that expert support is needed, it should consult with its medical or scientific 

review staffs to ensure that the Center position on the subject represents the consensus 

of current informed medical or scientific opinion. If necessary, the Center should also 

consult ORA to make this determination. See also FDA SMG 2610.2, Obtaining 

Services of Expert or Fact Witnesses (7/2/98).

The Center should also determine whether FDA will be able to obtain expert support for 

a case, when it is necessary to do so. The Center should not send a case forward to 

institute actual legal proceedings until it makes these determinations about expert 

support.

10-10-3Criteria For Determining The Level Of Expert Support

FDA requires outside expert support in precedent-setting cases when FDA does not 

have sufficient in-house expertise. If in-house experts are available, the Center should 
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contact them to determine whether it should also contact individuals from outside FDA 

to assess the consensus of current medical, scientific, or technical opinion.

The Center generally should review unprecedented issues and complex cases involving 

state- of-the-art and/or current good manufacturing practice to determine whether it 

should obtain concurrence by the experts.

The Center generally needs only limited additional expert support for cases that are 

sufficiently similar to previous cases, except where a new court decision, regulation, or 

policy has sufficiently changed the factors to consider.

The Center generally needs to refer only to recent cases when determining the need f 

or expert support in a current case that is identical to a recent case.

10-10-4Documentation

The Center’s approval memorandum for a case should include a section regarding 

expert support, under a separate heading. This section should summarize the Center’s 

effort to provide assurance of expert support and describe significant issues or concerns 

related to the expert support. It should also include relevant information about prior or 

pending court cases, testimony or affidavits developed during a recent court case or 

hearing, information derived during recent processes to propose or finalize rules, 

advisory committee meetings, literature searches that support the consensus of current 

opinion, memoranda of conversations with experts, etc.

10-10-5List Of Individuals For Expert Support

The Center should develop and maintain a list of experts. The Center might develop this 

information from a variety of sources, but it is responsible for assuring the adequacy of

the expert support for a case. For example, when the Center contacts an expert, it 

should consider asking that expert to identify other individuals with similar expertise. 

This may be useful in the case at hand (e.g., if a corroborating witness is needed) as 

well as in future cases.

10-10-6Obtaining And Paying For Expert Support

The Center might determine that FDA needs expert support from outside FDA to review 

a case and/or to serve as an expert witness. In that event, the Center should consult 

with other FDA components, e.g., Office of Chief Counsel and ORA division offices, to 

identify the most suitable witness, obtain the services of that individual, and pay for 

fees. Further background about obtaining the services of experts and paying for expert 

support is set out in an August 25, 2003, memorandum, Obtaining Services of and 

Paying for Expert Witnesses/Consultants--Policy from Donald Vasbinder, Acting 

Director, Office of Enforcement, to FDA Center and ORA managers. A copy of the 

memorandum can be found on Inside FDA - Home > Policies & Procedures > Guidance 

& Regulations: Enforcement > Payment/Costs.
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As explained in that memorandum, it is important to keep in mind the overall principle 

that each case is brought on behalf of the FDA, not any particular part of the 

organization. It is the responsibility of all involved elements of the FDA to cooperate and 

work together to provide the best possible support for all cases, regardless of which 

particular office may be the lead. Thus, it is the joint responsibility of the Center and field 

offices to identify and obtain the best witnesses and other case support, with the Office 

of Chief Counsel responsible for the final determination of use of witnesses if we 

anticipate a contest or litigating a case. Although the Centers have primary 

responsibility for assuring the availability of expert support, field offices should work 

closely with the Centers and provide any possible assistance in the process, such as 

identifying and suggesting to the Center possible good local experts. Field/Center 

consultation and cooperation on considering the possible need for and the obtaining of 

expert support should start as soon as necessary and feasible in the case development 

process and continue throughout each stage.

The following procedures are to be followed for obtaining and paying for the services of 

experts when needed for support of court cases or hearings:

1. Decisions are to be made jointly by the responsible Center and field offices on the 

type and scope of expert support needed for support of cases and hearings. It is 

also important that, if the agency anticipates that a case will be contested, the 

Office of Chief Counsel be consulted as to the use of expert witnesses. The office 

that first identifies the need to obtain expert support is responsible for contacting 

and consulting with the other offices responsible for the case.

2. For outside (non-FDA) consultants and expert witnesses agreed upon as 

necessary by all parties to support cases or hearings at any stage (including 

support for a recommendation, review and approval, and litigation), all costs 

associated with such services will be shared equally among each major office 

(other than OCC) having responsibility for the case (e.g., each Center and 

Division involved). This includes all necessary expenses for such expert services, 

such as contracting for and consulting with experts, travel and per diem, and other

associated expenses necessary for this purpose.

a. For outside experts, the responsible Center and field offices involved 

shall also consult and agree with one another on which office will be 

designated to take the lead role in actually contacting the expert, 

negotiating a contract for services, and making sure the necessary 

paperwork is completed.

b. Normally, unless mutually agreed otherwise, the designated lead office 

for these administrative purposes will be the one having primary 

responsibility for the aspect of the case that requires the expert 

support. For example:
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i. The Division would normally be the administrative lead for 

expert support (such as declarations) required for its regulatory 

action recommendations, or for expert witnesses needed for 

testimony for a trial or hearing under the Division’s purview.

ii. The Center would normally be the administrative lead if either 

the Center or OCC concluded in reviewing a recommended 

case that outside expert review is required to ensure adequate 

scientific support is available before proceeding with the case, 

or for expert witnesses needed for testimony at a hearing under 

the Center’s purview.

c. The designated lead office that prepares the necessary paperwork to 

procure the services for outside expert support is also responsible for 

ensuring timely payment of all invoices related to the services 

provided. In order to accommodate the shared- funding arrangement, 

the following accounting procedures should be employed:

i. When an ORA field office is designated as the lead for an 

outside expert:

The total expense should be charged to the applicable ORA field 

central funding CAN using category E. Accounting technicians 

should code field "N" of the DHR as follows:

"E (Last name of witness)"

Copies of each obligating document, including information 

concerning the Center with which the cost will be shared, should be 

sent to ORA’s, Division of Management Operations (DMO) using

the contact information on the division’s intranet page. DMO will 

provide the respective Center a copy of the obligating document for 

tracking purposes. Each quarter, DMO will contact the budget 

personnel in the applicable Center to request a transfer of funds to 

recover half of the total cost.

ii. When a Center is designated as the lead for an outside expert:

The total expense should be charged to the applicable Center’s 

accounting point. Copies of each obligating document, including 

information concerning the field location with which the cost will be 

shared, should be sent to DMO at using the contact information on 

the division’s intranet page. Each quarter, the applicable Center will 

contact the budget personnel in DMO to request a transfer of funds 

to recover its half of the total cost.
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3. For expert support provided by FDA employees, all such expenses (including 

travel and per diem) will be borne by the office of the employee involved. 

Expenses should be paid by the employee’s office in accordance with its normal 

procedures. 

NOTE: For expert support by FDA employees, this changes some provisions in 

sections 5.b. and 7.b.iii. of FDA SMG 2610.2, Obtaining Services of Expert or 

Fact Witnesses, which are somewhat in conflict.)

10-11 TESTIMONY; PRODUCTION OF RECORDS; CERTIFICATION OF 

RECORDS

Although FDA receives requests for information orally, in writing, and even in person at 

FDA offices, from parties including litigants, Congressional representatives and their 

staffs, and state and other federal officials,only writen requsts can be processed. Any 

FDA employee receiving a request should let the requestor know to file it in writing and 

preferably electronically. Before releasing any information to any person, FDA staff must 

carefully review the procedures in this Chapter including the special considerations 

described on 10-11-5 Requests Involving Special Circumstances and in the instructions 

for ORA employees in 10-12, U. S. Congressional Requests and in 10-13, Requests 

from State and Federal Officials.

10-11-1Requests for Testimony

FDA regulations at 21 CFR § 20.1 require that requests for testimony of FDA 

employees in non-FDA proceedings be handled in a specific manner. FDA employees 

are not permitted to provide testimony, whether written or oral, pertaining to any function 

of the FDA, or with respect to any information acquired in performing their official duties, 

unless authorized by the FDA Commissioner or another FDA official to whom this 

authority has been delegated. The FDA may authorize current FDA employees to 

provide testimony in any proceeding when the testimony will be in the public interest 

and promote FDA’s objectives and the laws it enforces. 21 CFR § 20.1. While 

interrupting the normal duties of FDA employees to provide testimony in a proceeding to 

which the agency is not a party is generally not considered to be in the public interest, 

FDA may be able to honor a request for testimony by providing responsive documents. 

The FDA can also certify these documents for presentation in court.

The FDA processes written requests for testimony in accordance with 21 CFR § 20.1. 

Affidavits, declarations, and employees’ responses to depositions, interrogatories, or 

rogatory letters are considered to be testimony covered by 21 CFR § 20.1. See 10-11-8 

Definitions. Under no circumstances does the FDA process verbal requests for 

testimony.
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The Director, OSPOP, ORA has been delegated the authority to authorize the giving of 

testimony under 21 CFR § 20.11, and is the agency lead for authorizing all testimony. In 

addition to the Director, OPSPO, the following officials have the authority to authorize 

the giving of testimony under 21 CFR § 20.1: the ACRA; and the Deputy ACRA, ORA 

See SMG 1410.24 for these delegations.

ORA’s Office of Partnerships and Operational Policy (OPOP)/ Office of Strategic 

Planning and Operational Policy (OSPOP)/Division of Information Disclosure Policy 

Information (DIDP)/Disclosure Policy Branch (DPB) conducts the initial review of all

requests for testimony , and DPB then prepares a 21 CFR § 20.1 package for the 

review and signature of the Director, OSPOP.

FDA employees may be asked to assist DPB in responding to a request for testimony, 

by identifying suitable individual(s) to testify, drafting authorized testimony, or identifying 

records (instead of testimony) that are responsive to the request.

If a request involves Congress, employee personnel records, the DHHS Office of Equal 

Employment Opportunity, the investigation of an FDA employee by the DHHS Inspector 

General, the testimony of an FDA employee as a private citizen, or the testimony of a 

former employee regarding FDA-related matters, see the instructions in “Requests 

involving Special Circumstances” below. Otherwise,

1. If you receive a written request for testimony (whether by letter, subpoena, 

or in any other form) that was submitted by, or on the behalf of any person, 

contact DPB immediately and send the original request to that office at the 

address below.

U.S. Food and Drug Administration

Office of Partnerships and Operational Policy

Office of Strategic Policy and Operational Policy

Division of Information Disclosure Policy

1 Pursuant to Staff Manual Guide (SMG) 1410.24, Disclosure of Official Records and Authorization of Testimony, dated April 27, 

2007, the Commissioner of Food and Drugs (Commissioner) has delegated to “Director, Division of Compliance Policy” (DCP), 

among others, the authority to the make determinations to authorize the testimony of an FDA employee in litigation in which the FDA 

is not a party pursuant to 21 C.F.R. § 20.1. It is well established that DCP was reorganized into the Office of Strategic Planning and 

Operational Policy (OSPOP) and kept the same functions. According to SMG 1401.1, Policy and Procedures Governing Regulatory 

and Administrative Delegations of Authority (DOAs), paragraph G, delegations to an organization remain in effect in a successor 

organization with the same functions. Therefore, as the successor organization to DCP, Director of the Office of Strategic Planning 

and Operational Policy (OSPOP) has the authority to grant requests for testimony pursuant to 21 C.F.R. 20.1. The OSPOP Director 

will have primary responsibility for ORA’s 20.1 authorizations.

Note: Per the SMG, the Deputy Associate Commissioner for Regulatory Affairs (Deputy ACRA), ORA; the Director and Deputy 

Director, Office of Enforcement OE, ORA; and the Director, Division of Compliance Policy, OE, ORA are all delegated the authority 

to grant requests for testimony or to authorize the giving of testimony under Sec. 20.1 of 21 CFR. These officials may not further 

redelegate this authority.
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Disclosure Policy Branch

c/o Testimony Specialist

12420 Parklawn Drive

(Element Bldg., RM. 4042)

Rockville, MD 20857

To expedite processing, a scanned copy of the testimony request should also be 

sent to the FDA Outlook address for the ORA OSPOP Testimony – Info Sharing 

Team at ORAInfoshare@fda.hhs.gov.

2. If you are contacted by individuals requesting testimony:

a. Either refer the individuals to a Testimony Specialist at the FDA 

Outlook address for the ORA OSPOP Testimony – Info Sharing Team 

in DIDP/DPB, or advise them that FDA does not process verbal 

requests for testimony and that they should submit a written testimony 

request to the address for DPB shown above, well in advance of their 

desired due date to allow time for evaluating and processing the 

request; and that they should include information about the hearing 

body, date, location, and purpose of the proceeding; the nature and 

scope of the testimony the FDA is being asked to provide and the use 

to which it will be put; the name(s) of the FDA employees, if known, 

being asked to testify; the requester's interest in the matter sought to 

be disclosed; the requester's rationale for considering that the 

testimony is in the public interest and will promote the objectives of 

FDA and the laws it enforces; and any other relevant background. 

Refer them to 21 CFR § 20.1(c) for FDA’s procedures on how to make 

these requests.

b. Do not make any commitment regarding the availability or willingness 

of a witness to testify in any particular case.

c. Document the conversation, and send DIDP/DPB a memorandum by 

email and contact that office to confirm receipt.

3. If you have been authorized to testify:

a. Before presenting testimony, contact the assigned OCC attorney, to 

obtain legal advice; and the appropriate FDA component, to obtain any 

technical advice you believe you need and, if needed, information 

about funding travel.

b. After presenting testimony, submit a summary memorandum or copy of 

the testimony or a transcript of the testimony to the Testimony 

Specialists in DPB and to OCC. If the Director, OSPOP, authorizes the 

testimony for a hearing in a state court, the summary memorandum 
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you prepare should address not only the individual's testimony, but 

also any other portions of the hearing that the individual attended.

10-11-2Requests for Production of Records

The Director, OSPOP, is the agency official with delegated authority who is the lead for 

responding to subpoenas for the production of records made pursuant to 21 CFR § 

20.21.

If a request involves Congress, employee personnel records, the DHHS Office of Equal 

Employment Opportunity, the investigation of an FDA employee by the DHHS Inspector 

General, the testimony of an FDA employee as a private citizen, or the testimony of a 

former employee regarding FDA-related matters, see the instructions for ORA 

employees in 10-12, U.S. Congressional Requests and in 10-13, Requests from State 

and Federal Officials. Otherwise,

1. If you receive a written request or a subpoena, including a subpoena duces 

tecum, for the production or certification of records:

Send the request to the address for the Testimony Specialist, DPB

shown above.

2. If you are contacted by an individual requesting the production or 

certification of records:

a. Either refer the individuals to the Testimony Specialist, DPB; or advise 

them that FDA does not process verbal requests for records and that 

they should submit a written request to the address for the Testimony 

Specialist, DPB (shown above in “If you receive a written request for 

testimony”) well in advance of their desired due date to allow time for 

evaluating and processing the request; and that they should include 

1 Pursuant to Staff Manual Guide (SMG) 1410.24, Disclosure of Official Records and Authorization of Testimony, dated April 27, 

2007, the Commissioner of Food and Drugs (Commissioner) has delegated to “Director, Division of Compliance Policy” (DCP), 

among others, the authority to the make determinations to authorize the testimony of an FDA employee in litigation in which the FDA 

is not a party pursuant to 21 C.F.R. § 20.2. It is well established that DCP was reorganized into the Office of Strategic Planning and 

Operational Policy (OSPOP) and kept the same functions. According to SMG 1401.1, Policy and Procedures Governing Regulatory 

and Administrative Delegations of Authority (DOAs), paragraph G, delegations to an organization remain in effect in a successor 

organization with the same functions. Therefore, as the successor organization to DCP, Director of the Office of Strategic Planning 

and Operational Policy (OSPOP) has the authority to grant requests for testimony pursuant to 21 C.F.R. 20.2. The OSPOP Director 

will have primary responsibility for ORA’s 20.2 authorizations.

Note: Per the SMG, the Deputy Associate Commissioner for Regulatory Affairs (Deputy ACRA), ORA; the Director and Deputy 

Director, Office of Enforcement OE, ORA; and the Director, Division of Compliance Policy, OE, ORA are all delegated the authority 

to grant requests for testimony or to authorize the giving of testimony under Sec. 20.2 of 21 CFR. These officials may not further 

redelegate this authority.
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specific information about the records requested, the requested due 

date, and any other relevant background. Refer them to 21 CFR § 20.2 

for FDA’s procedures for processing these requests.

b. Do not make any commitment regarding the availability of records.

c. Document the conversation, and send DPB a memorandum by email 

or and contact that office to confirm receipt.

10-11-3 Multi-issue Subpoena - Requests for Samples

If you receive a subpoena or a request that seeks FDA records, testimony, and actual 

samples for litigation (not for first party request for a 702(b) sample), you should: (1) 

refer the sender of the request/subpoena for the samples to the Testimony Specialist, 

DPB, who, if needed, will consult with OCC for a response pursuant to 21 CFR § 2.10, 

and if involved, OCI; and (2) process the remaining portion of the request/subpoena as 

a request for testimony and for records.

FDA considers a request/subpoena for analytical results to be a request for records.

10-11-4Requests for Certification of Records

FDA processes requests for certification of records in accordance with 21 CFR § 20.3. If 

you are asked to certify records, contact DPB by email at the FDA Outlook address for 

the ORA OSPOP Testimony – Info Sharing Team. DPB will forward requests for the 

certification of records to the appropriate component for direct response.

10-11-5Requests involving Special Circumstances

If you receive a request that involves:

1. An FDA proceeding or a DHHS proceeding where FDA is involved – contact 

DPB, if that office is not already involved or aware of the request. DPB will 

coordinate with other entities as needed.

2. Congress – contact FDA’s Office of Legislation, except as noted in instructions 

for ORA staff in sections 10-12, Congressional Requests and in 10-13, Requests 

from State and Federal Officials below.

3. Employee personnel records related to litigation – contact DPB. DPB will 

coordinate with other entities as needed.

4. An investigation of an FDA employee by the DHHS Inspector General - contact 

FDA’s Office of Internal Affairs (HFH-560) in the Office of Criminal Investigations.
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5. The DHHS Office of Equal Employment Opportunity – contact FDA’s EEO and 

Diversity Management Office (HF-15), in the Office of Shared Services.

6. Testimony as a private citizen - Some testimony as a "private citizen" (i.e., not in 

one's official FDA capacity) may raise special concerns such as possible conflict 

of interest or may require approval as an outside activity. 

NOTE: If the individual’s planned testimony is based on information derived 

during FDA employment, the employee must contact DIDP/DPB for clearance of 

this testimony under 21 CFR § 20.1. For testimony as a private citizen, 

employees also should refer to the Standards of Ethical Conduct for Employees 

of the Executive Branch, 5 CFR § 2635.805, and the HHS Supplemental 

Standards of Ethical Conduct, 5 CFR § 5501.106. Contact FDA’s Ethics and 

Integrity Staff for further information regarding approval of the testimony as an 

outside activity.

7. Testimony by former FDA employees - Requests for the testimony of former FDA 

employees are not covered specifically by 21 CFR § 20.1. However, we

encourage former employees to contact DPB if they receive a request or 

subpoena to provide testimony regarding FDA-related matters, because FDA 

may assist that individual on behalf of FDA. Advise former employees that there 

may be other restrictions on their ability to provide the requested testimony, 

including possible conflict of interest concerns and statutory and regulatory 

restrictions on the release of trade secrets and other kinds of confidential 

information.

10-11-6Disclosure of Non-public information

FDA generally discloses information pursuant to a request or subpoena if that 

information is neither exempt from disclosure under FOIA nor prohibited from disclosure 

by other law, and the disclosure is consistent with FDA’s part 20 regulations.

In certain circumstances, with the appropriate authorization, transmittal procedures, and 

disclosure reviews, FDA may share certain non-public information that is otherwise 

exempt or prohibited from disclosure, e.g., 21 CFR § 20.85 (disclosure to other federal 

agencies), 21 CFR § 20.88(d) (disclosure to state and local agencies), or 21 CFR 

20.89(c) (disclosure to foreign agencies). Any request for non-public information from a 

federal or state agency must be sent to the Testimony Specialists in the Division of 

Information Disclosure Policy/Office of Strategic Policy and Operational Planning/ORA 

at the FDA Outlook address for the ORA OSPOP Testimony – Info Sharing Team. See 

also RPM Chapter 3 Commissioning > Confidentiality. Any request for non-public 

information from a foreign agency must be sent to the Office of Partnerships 

International and Federal Engagement staff at the FDA Outlook address for ORA OP DI 

International and Federal Group.
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Other examples of instances in which FDA may share non- public information are set 

forth below.

1. FDA may share under 21 U.S.C. § 372(a) certain non-public information, 

including trade secrets, personal privacy, open investigatory, and confidential 

commercial information, , with federal or state officials commissioned by FDA 

under law. For questions contact Office of Partnerships at the FDA Outlook 

address for ORA State Commissioning . See also RPM Chapter 3 

Commissioning > Confidentiality.

2. FDA may share under 21 CFR § 20.90 certain non-public information with other 

government officials under agreements or contracts that contain appropriate 

confidentiality provisions. For questions contact Office of Partnerships at the FDA 

Outlook address for ORA OP Feedback.

10-11-7Other Requests for Information – Informal Meetings

A person (individual, company, corporation, etc.) might request an informal meeting with 

an FDA employee to discuss information the employee obtained during the course of 

his or her employment.

1. If the requester is not an official from another government agency, and if private 

civil litigation is involved, decline the request and suggest that the requester 

submit a request for testimony under 21 CFR 20.1. Also, advise the requester 

that FDA has a long- standing practice against granting one-sided interviews or 

informal testimony to avoid creating the impression that FDA is biased toward a 

party.

2. If the requester is not an official from another government agency, and if the 

request relates to a matter other than private civil litigation (e.g., the requester 

seeks general information about FDA’s activities), advise the requester to submit 

a written request to FDA, to be handled as general correspondence under routine 

office procedures.

3. If the requester is an official from another government agency, advise the 

requester to submit a written request to FDA to be handled under appropriate 

agency procedures for the sharing of publicly releasable or non-public 

information under RPM Chapter 3 Commissioning > Confidentiality and in

Instructions for ORA employees in 10-12, U. S. Congressional Requests and in 

10-13, Requests from State and Federal Officials. Contact OCI’s information 

disclosure senior investigator if the request is from a law enforcement agency 

and the request is for non-public information.

Consult with DIDP if needed at the FDA Outlook address for the ORA OSPOP 

Testimony – Info Sharing Team.
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10-11-8Definitions

The following list contains definitions of commonly used terms in the context of 

testimony, subpoenas, or production of records.

Affidavit - A written document signed in the presence of a notary public under a sworn 

oath that the statement is true. FDA considers an affidavit to be testimony covered by 

21 CFR 20.1.

Certification (also known as “certificate”) - A written assurance, or official 

representation, that some act has or has not been done, or some event occurred, or 

some legal formality has been complied with. Typically, a requester will ask that FDA 

certify as to the authenticity of an FDA record as a true copy. FDA processes requests 

or subpoenas for certification under 21 CFR 20.3.

Declaration - A written statement signed under the penalty of perjury. A declaration can 

substitute for an affidavit in federal court proceedings. 28 U.S.C. 1746. FDA considers a 

declaration to be testimony covered by 21 CFR 20.1.

Deposition - The taking and recording of testimony of a witness under oath, in front of a 

court reporter prior to trial and away from the courtroom. FDA considers an employee’s 

responses in a deposition to be testimony covered by 21 CFR 20.1.

Interrogatories - Written questions sent by one party in a lawsuit to the other party 

during the discovery process prior to trial. Interrogatories must be answered in writing 

under oath or under penalty of perjury. FDA considers the employee’s response to 

interrogatories to be testimony covered by 21 CFR 20.1.

Notary Public - A person authorized by the state in which they reside to administer an 

oath of truth to a person making an affidavit, and to apply their signature and seal or 

stamp to attest to the oath.

Rogatory Letters - A written request from a judge in one state to a judge in another, 

asking that the latter take the testimony of a witness. FDA considers testimony in 

response to rogatory letters to be covered by 21 CFR 20.1.

Subpoena - A court order commanding a witness to appear at a certain time and place 

to testify on a certain matter. For purposes of this section, a “subpoena” means a 

subpoena for verbal or written testimony (e.g., an affidavit). A subpoena for testimony 

also might include a request for records. In that case, FDA would process the subpoena 

under 21 CFR 20.1 and 20.2.

Subpoena Duces Tecum - A court order commanding a witness to produce documents 

at a certain time and place. FDA processes these subpoenas, which are intended for 

the production of records, under 21 CFR 20.2.
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Testimony - For purposes of this section, testimony is an individual’s statement given in 

writing (such as an affidavit or a declaration) or by appearance under oath at a 

proceeding. The statement might be in response to a deposition or interrogatories. 

Testimony is covered by 21 CFR 20.1.

10-11-9References

The following list contains references commonly used in the context of testimony, 

subpoenas, or production of records.

1. "Enforcement Notes,” Issue No. 85, September 18, 2002, Testimony, available on 

ORA’s Intranet

2. Staff Manual Guide 1410.21(General Redelegations of Authority from the 

Commissioner to other Officers of the Food and Drug Administration)

3. Staff Manual Guide 1410.23 (Certification of True Copies and Use of Department 

Seal)

4. Staff Manual Guide 1410.24 (Disclosure of Official Records and Authorization of

Testimony)

5. Staff Manual Guide 2127.1 (Attendance by FDA Employees at Congressional 

Hearings)

6. Staff Manual Guide 2127.2 (Requests for Testimony of FDA Personnel in NonFDA Proceedings)

7. Staff Manual Guide 2460.7 (Procedures for Implementing the Freedom of 

Information Act) (Not on Intranet)

8. 5 U.S.C. § 552a (Privacy Act); 21 CFR Part 21(Privacy Act regulations)

9. 5 U.S.C. § 552(b) (Freedom of Information Act (FOIA)); 21 CFR Part 20 (FOIA 

regulations), particularly 21 CFR 20.1, 20.2, and 20.3

10.5 CFR § 2635.805 (Standards of Ethical Conduct for Employees of the Executive 

Branch; Service as an expert witness)

11.5 CFR § 5501.106 (HHS Supplemental Standards of Ethical Conduct; Outside 

employment and other outside activities

12.Information Disclosure Manual on ORA’s Intranet Information Disclosure Main 

Page

13.FDA’s FOIA Page on FDA’s Intranet
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10-12 U. S. CONGRESSIONAL REQUESTS – INSTRUCTIONS FOR 

ORA EMPLOYEES

Whether any ORA field or headquarters employees may directly answer an inquiry 

from U.S. Congressional staff (House or Senate) in their district’s geographical area or 

must refer the inquiry to ORA’s Executive Secretariat Staff (ESS) depends on the 

source and subject matter of the inquiry, as detailed below.

1. The following type of U.S. Congressional (House or Senate) inquiries may be 

answered directly by ORA field or headquarters employees: 

a. Inquiries from Congressional staff located in a district’s geographical 

area that concern issues of general interest and can be answered 

using approved information already available to the public (e.g., copies 

of public documents, FDA publications, talking points, press releases, 

Federal Register notices, or other published materials). 

i. ORA employees should refer the Congressional staff located in 

their district’s geographical area to FDA’s public websites, 

where many of these materials are available online.

b. Inquiries from Congressional staff located in a district’s geographical 

area that request information about an import entry in “may proceed” 

status that is “closed” for ORA.

i. ORA employees may refer these inquires to FDA’s public 

website for its import entry system - Import Trade Auxiliary 

Communication System (ITACS): 

https://itacs.fda.gov/app/welcomeToITACS.jsf.

Note: “May Proceed” status indicates that the entry has been 

released without any further action by FDA and is considered 

“closed.”

“May Proceed” status does not include entries in which there 

was an examination, sampling, detention, etc. Those inquiries 

must be referred to FDA’s Office of Legislation (OL) through 

ESS.

2. The following types of U.S. Congressional (House or Senate) inquiries must be

referred to ESS:

a. Inquiries that originate from the staff of a Congressional office located

in Washington, D.C.
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b. Inquiries involving legislative, policy, or budget issues that are national 

in scope (e.g., issues that are receiving major press coverage, are the 

subject of pending Federal legislation, involve FDA expenditures, etc.).

c. Inquiries regarding FDA inspections, investigations, sample 

collection/analysis, litigation, or pending product approvals.

d. Inquiries that involve import entries in any status other than “may 

proceed,” as defined in section 1(b) above.

e. Inquiries regarding cases in litigation or pending product approvals.

f. Any inquiries that require a formal, written response.

Submit the inquiry or refer the requesters to ESS via the FDA Outlook address 

for the ORA OCPM Executive Secretariat Staff within one business day of 

receiving the inquiry. To ensure the expeditious handling of the inquiry, please 

include “Congressional Inquiry” in the subject line of your email. 

Upon receipt, ESS will refer the inquiry to OL’s Congressional Correspondence 

Team to collect information/data and issue the official agency response to the 

requester.

Federal (non-congressional) inquiries are processed by ORA’s Federal-State 

Health Communications and Relations (FSHCR) program manager. Submit 

federal (non-congressional) inquiries to the FSHCR program manager at the FDA 

Outlook address for DivComm-ORAORA’s per RPM 10-13-3, Procedures for 

Handling Inquiries from Federal Agencies. Additionally, if the federal request is 

for non-publicly available records, forward the request to the FDA Outlook 

address for the ORA OSPOP Testimony – Info Sharing Team in DIDP/DPB with 

a copy to the FSHCR program manager at the FDA Outlook address for 

DivComm-ORA.

Inquiries from state, local, tribal, and territorial government officials must be 

processed per RPM 10-13-4 Procedures for Handling Inquiries from Other 

State, Local, Tribal, and Territorial Government Officials unless the inquiry 

concerns non-publicly available information or is solely a records request; in 

those cases, forward the request to to the FDA Outlook address for the ORA 

OSPOP Testimony – Info Sharing Team in DIDP/DPB with a copy to to the 

FSHCR program manager at the FDA Outlook address for DivComm-ORA.

If you have any questions regarding U.S. Congressional inquiries, call or email ESS 

or OL. Contact information below:

Executive Secretariat Staff
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Email address: use the FDA Outlook address for ORA OCPM Executive 

Secretariat Staff

Phone: (301) 796-5231 

Fax: (301) 827-0963 

Office of Legislation 

Congressional Correspondence Team

Email address: use the FDA Outlook address for legislation

Phone: (301) 796-8900

Fax: (301) 827-8602 or (301) 847-8603 

10-13 REQUESTS FROM STATE AND FEDERAL OFFICIALS –

INSTRUCTIONS FOR ORA EMPLOYEES

10-13-1Background

Be aware of changes in 2014 in the handling of inquiries and requests for information 

and reports (henceforth referred to as inquiries) originating from state government 

officials and national associations representing state government officials (State 

government officials include governors, attorneys general, state legislators, and other 

officials in state, local, tribal, and territorial governments.) Historically, these inquiries 

were handled by the Office of Partnerships (OP) in ORA. These requests included most 

inquiries involving actions and matters that were policy-related and operational in 

nature. In addition, ORA’s district and regional offices responded directly to inquiries 

from state legislatures within their boundaries when the inquiries involved issues of

general interest that could be answered using cleared information available to the 

public.

With the exception of testimony and subpoena requests that fall under 21 C.F.R §§ 

20.1, 20.2 and non-public information and records requests that fall under 21 CFR

§§20.85, and 20.88 (all of which are managed by DIDP), responsibility for handling and 

coordinating agency responses to policy-related and operational-type inquiries from 

these entities was moved from the OP to ORA’s Division of Communications in March 

2014 as part of ORA’s realignment and consolidation of all communications and public 

affairs staff and functions into a newly established Division of Communications. Under 

this ORA realignment, the FSHCR program manager in ORA’s Division of 

Communications was charged with handling and coordinating responses to policyrelated and operational-type inquiries from state congressional officials, other state, 

local, tribal, and territorial government officials, and national associations representing 

state government officials.

In September 2014, FDA’s Office of Policy, Planning, and Legislation (OPPL) signed a 

Service Level Agreement (SLA) with ORA that outlined the responsibilities of ORA and 

of OPPL’s newly created Intergovernmental Affairs (IGA) staff, with new procedures for 
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handling inquiries from state congressional officials and the national associations that 

represent state government officials.

1. Under the SLA, IGA is responsible for handling responses to policy-related 

inquiries from state congressional officials and the national associations 

representing state government officials. ORA, however, retains responsibility for 

handling and coordinating operational-type responses to inquiries from those 

groups.

a. Inquiries that are policy-related generally pertain to questions 

regarding FDA laws, regulations, policies, guidance, and rulemaking.

b. Inquiries that are operational in nature usually involve regulatory 

actions such FDA investigations and compliance/enforcement 

activities. Examples include warning letters, embargos, injunctions, 

seizures, etc.) as well as information on illness outbreaks and injuryrelated events involving FDA-regulated products.

2. The SLA designates the following as points of contact and liaisons in ORA and 

OPPL: the director and staff of IGA, which is part of OPPL, and the FSHCR 

program manager. They are variously responsible for handling and coordinating 

different kinds of policy-related and operational inquiries from state congressional 

officials and the national associations representing state government officials.

10-13-2Procedures for Handling Inquiries from State Congressional Officials and 

their Staff 

In accordance with the SLA, all inquiries, unless solely a request for records or a 

request for non-public information, that originate from state congressional officials (e.g., 

state senator, state representative, state assemblyman) and their staff must be referred 

either to the FSHCR program manager in ORA’s Division of Communications or IGA 

Staff for further processing as detailed below. If solely records are requested, or the 

release of non-public information is implicated, contact DBP/DIDP at the FDA Outlook 

address for ORA OSPOP Testimony – Info Sharing Team.

1. The FSHCR program manager will handle responses to inquiries that are 

operational in nature and involve regulatory actions such as FDA inspections, 

investigations, and compliance/enforcement actions (e.g., warning letters, 

embargos, injunctions, seizures, inspections, etc.) and activities like work 

planning, emergency response, and sample collection. This responsibility 

includes coordinating with the responsible FDA center/office and the Office of 

Chief Counsel (OCC) to develop and clear the response as required. It also 

entails coordinating with DBP/DIDP if records are requested or if non-publicly 

available information may be released pursuant to 21 CFR § 20.88. 
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a. ORA field and headquarters employees must refer the inquiry to the 

FSHCR program manager for further processing within one business 

day of receipt of the inquiry. To ensure the expeditious handling of the 

inquiry, “State Congressional Inquiry” should be in the subject line of 

the email. 

i. The FSHCR program manager referenced above must contact 

the requester to acknowledge receipt of the inquiry and provide 

a projected time frame when a response will be provided.

ii. The FSHCR program manager will provide the cleared 

response to the requestor as expeditiously as possible after 

receipt of the inquiry. If significant delays are encountered with 

coordinating or clearing the response, the FSHCR program 

manager will inform the requestor of the delay, along with a 

projected date or time frame when the cleared agency response 

will be provided to them.

2. The IGA staff will handle inquiries that are policy-related and involve FDA 

legislation, legislative testimony, guidances and rulemaking, FDA-regulated 

products, and tobacco.

a. ORA field and headquarters employees must forward the inquiry to the 

FSHCR program manager at the FDA Outlook address for DivCommORA for further processing within one business day of receipt of the 

inquiry. To ensure the expeditious handling of the inquiry, “State 

Congressional Inquiry” should be in the subject line of the email. 

b. The FSHCR program manager will forward the inquiry within one 

business day of receipt to the IGA Staff to handle and coordinate the 

response to the inquiry.

3. The IGA staff will handle responses to inquiries that are policy-related and 

involve pharmacy compounding issues.

a. ORA field and headquarters employees must forward the inquiry within 

one business day of receipt directly to the IGA staff at the FDA Outlook 

address for the IGA, with copies sent to the FSHCR program manager 

at the FDA Outlook address for DivComm-ORA and to the Outlook 

address for ORA Compounding ICS.

4. For inquiries that are a combination of policy-related and operational in nature, 

the IGA staff and FSHCR program manager will collaboratively review the inquiry 

to determine who will take the lead in handling and coordinating the response to 

the inquiry.
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5. ORA field and headquarters employees who have questions regarding whether 

an inquiry is policy-related or operational in nature may forward the inquiry to the 

FSHCR program manager to determine how it should be handled.

10-13-3Procedures for Handling Inquiries from Federal Agencies

With the exception of inquiries from the HHS Office of the Inspector General (OIG) and 

U.S. Government Accountability Office (GAO), the FSHCR program manager handles 

all inquiries for publicly available information from other federal agencies sent to any 

ORA employee. If records are requested or the release of non-public information is 

contemplated, coordination must be made with the DPB/DIDP to determine if nonpublicly available information may be released pursuant to 21 CFR § 20.85. 

Additionally, OSPOP is responsible for coordinating ORA’s response to inquiries 

involving GAO studies and OIG audits.

1. ORA field and headquarters employees must forward the federal agency inquiry 

directly to the FSHCR program manager at the FDA Outlook address for 

DivComm-ORA for further processing within one business day of receipt of the 

inquiry. To ensure the expeditious handling of the inquiry, “Federal Agency 

Inquiry” should be in the subject line of the email. 

2. For federal inquiries from the HHS OIG and US GAO, ORA field and 

headquarters employees must forward the inquiry to the FDA Outlook address 

for the GAO ORA Liaison in ORA’s OSPOP with a copy to the FSHCR program 

manager at the FDA Outlook address for DivComm-ORA within one business 

day of receipt of the inquiry.

3. If solely records are requested, or the release of non-public information is 

implicated, the FSHCR must contact DBP/DIDP at the FDA Outlook address for 

the ORA OSPOP Testimony – Info Sharing Team.

10-13-4Procedures for Handling Inquiries from Other State, Local, Tribal, and 

Territorial Government Officials and National Associations

Regarding inquiries from other state, local, tribal, and territorial government officials and 

the national associations representing these officials: The source and subject matter 

determine whether the inquiry should be handled by ORA field employees or be referred 

to the FSHCR program manager or IGA staff for further processing. See details below.

1. The following types of inquiries from non-elected state, local, tribal, and territorial 

government officials and national associations representing these officials may 

be answered directly by ORA field and headquarters employees:
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b. Inquiries that deal with issues of general interest that can be answered 

with approved information and reports available to the public (e.g., 

copies of public documents, FDA publications, Field Alert Reports, 

talking points, press releases, Federal Register notices, or other 

published materials). When applicable, ORA employees should refer 

the requestor to FDA’s public website, where many of the materials are 

available online.

c. Inquiries involving operational matters such as requests for information 

about pending or recommended compliance/enforcement actions, 

within five working days of completion of a violative inspection, events 

related to illness and injury involving regulated products, and 

emergency situations subject to appropriate information disclosure 

requirements. If solely records are requested or the release of nonpublic information is implicated, ORA employees must contact 

DBP/DIDP at the FDA Outlook address for the ORA OSPOP 

Testimony – Info Sharing Team.

d. Field or headquarters employees must provide a cleared response to 

the requestor as expeditiously as possible after receipt of the inquiry. If 

significant delays are encountered with coordinating or clearing the 

response, the requestor must be informed of the delay along with a 

projected date or time frame when the cleared agency response will be 

provided to them. 

2. The following types of inquiries from elected and high-level other state, local, 

tribal, and territorial government officials and their staff, as well as the national 

associations representing these officials, must be referred to the FSHCR 

program manager or IGA staff for further processing as detailed below:

a. The FSHCR program manager will handle responses that involve 

operational issues.

i. ORA field and headquarters employees must forward the inquiry 

to the FSHCR program manager at the FDA Outlook address 

for DivComm-ORA for further processing within one business 

day of receipt of the inquiry. To ensure the expeditious handling 

of the inquiry, “State Government Inquiry” should be in the 

subject line of the email. If solely records are requested or the 

release of non-public information is implicated, ORA employees 

must contact DBP/DIDP at the FDA Outlook address for the 

ORA OSPOP Testimony – Info Sharing Team with a copy to 

FSHCR program manager at the FDA Outlook address for 

DivComm-ORA.
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b. IGA staff will handle responses to inquiries that involve legislative, 

policy, budget matters, and high interest issues that are national in 

scope (e.g., issues that are receiving major press coverage, are the 

subject of pending federal legislation, involve FDA expenditures, etc.) 

However, send the inquiries to the FSHCR project manager for initial 

handling. 

i. ORA field and headquarters employees must forward the inquiry 

to the FSHCR program manager for further processing within 

one business day of receipt of the inquiry. To ensure the 

expeditious handling of the inquiry, “State Government Inquiry” 

should be in the subject line of the email. 

ii. The FSHCR program manager will forward the inquiry within 

one business day of receipt to the IGA Staff at the FDA Outlook 

address for IGA to handle and coordinate the response to the 

inquiry.

c. The IGA staff will handle the response to policy-related pharmacy 

compounding inquiries.

i. ORA field and headquarters employees must forward the inquiry 

within one business day of receipt directly to the IGA staff at the 

FDA Outlook address for the IGA to handle and coordinate the 

response to the inquiry, with copies sent to the FSHCR program 

manager at the FDA Outlook address for DivComm-ORA and to 

the Outlook address for ORA Compounding ICS. To ensure the 

expeditious handling of the inquiry, “State Pharmacy

Compounding Inquiry” should be in the subject line of the email.

10-14 APPLICATION INTEGRITY POLICY

The Application Integrity Policy (AIP) describes the agency's approach regarding the 

review of applications that may be affected by wrongful acts that raise significant 

questions regarding data reliability. FDA published this policy, formally titled, "Fraud, 

Untrue Statements of Material Facts, Bribery, and Illegal Gratuities; Final Policy" in the 

Federal Register on September 10, 1991 (56 FR 46191), and in Compliance Policy 

Guide (CPG) 7150.09. See Sec. 120.100 of the Compliance Policy Guides publication. 

These documents, procedures to implement the AIP, and AIP information are available 

on the FDA Application Integrity page.
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10-15 EXHIBIT

Exhibit 10-1 – SECTION 414 OF THE FD&C ACT RECOMMENDATION MEMORANDUM

To: Director, Division of Enforcement, Office of Regulatory Affairs 

From: Program Division Director or Designee

Date: 

Re: Formal Recommendation for Invoking Records Inspection Authority under Section 414 

of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350c]

Firm Identification #(s): Insert firm name, address, and FEI number (may not be a farm or 

restaurant)

Dates of Inspection:

Details of Record Refusal: Provide information on the facts of the records refusal and 

FDA’s attempts at obtaining the necessary records or provide the background of past 

experiences with the firm, if the Division anticipates the firm may refuse to provide access to 

records. 

Section 414 of the FD&C Act Statutory Requirements: Outline evidence supporting why

the Division believes the current situation meets the statutory requirements of section 414 of 

the FD&C Act. This may be done with a bulleted list to describe how the requirements are 

met under either section 414(a)(1) or 414(a)(2) of the FD&C Act. Examples include but are 

not limited to: Description of foodborne outbreak; sample results; or inspectional 

observations. 

• Section 414(a)(1) of the FD&C Act: FDA has a reasonable belief that an article of 

food, and any other article of food that FDA reasonably believes is likely to be 

affected in a similar manner, is adulterated and presents a threat of serious adverse 

health consequences or death to humans or animals (SAHCODHA).

• Section 414(a)(2) of the FD&C Act: FDA believes that there is a reasonable 

probability that the use of or exposure to an article of food, and any other article of 

food that FDA reasonably believes is likely to be affected in a similar manner, will 

cause SAHCODHA.

Records to Request: Include a bulleted list of records to request and summarize, in one to 

two sentences, the rationale for why section 414 of the FD&C Act authorizes FDA to access 

and copy these records. 

• The records should relate to the article in question and to any other article of food 

believed to be affected in a similar manner. 

• The records should be necessary to assist in determining whether the food is 

adulterated and presents a threat of SAHCODHA, or there is a reasonably 

probability that use of or exposure to the food will cause SAHCODHA. 

• Examples include: Receiving records for raw materials or finished product; 

production records; sanitation records; testing records; inventory; distribution 

records; and complaints and adverse event reports.
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• Section 414 records inspection authority excludes recipes for food, financial data, 

pricing data, personnel data, research data, or sales data (other than shipment data 

regarding sales).

Timeframe for Issuance of Form FDA 482c: Provide a timeframe for when the Division 

could issue Form FDA 482c, if approved. Include any concerns surrounding issuance (e.g. 

personal safety during issuance).

Program Division Director or designee Signature Block

Center Concurrence:

As an official delegated with the authority to make determinations under section 414(a) of 

the FD&C Act, I have determined there is a reasonable belief, based on the information 

noted above and facts presented to date, that [an article of food] [manufactured, processed, 

packed, distributed, received, held, or imported] by [firm name] is adulterated and presents 

a threat of serious adverse health consequences or death to humans or animals 

(SAHCODHA) or that there is a reasonable probability that use of or exposure to the food 

will cause SAHCODHA.

I concur with the recommendation to invoke records inspection authority under section 414 

of the FD&C Act. 

Delegated Official per SMG 1410.306 Signature Block