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09-10-0013 Employee Conduct Investigative Records, HHS/FDA/OM

System name:

Employee Conduct Investigative Records, HHS/FDA/OM.

Security classification:


System location:

Office of Internal Affairs (HF-9), Office of the Commissioner, 1801 Rockville Pike, Suite 405, Rockville, MD 20857.

Categories of individuals covered by the system:

Employees or former employees, or special Government employees of FDA who are alleged to have violated FDA or Departmental regulations and/or Federal statutes.

Categories of records in the system:

This system includes records relating to correspondence concerning an individual's employment status or conduct while employed by FDA. Examples of these records include: Correspondence from employees, members of Congress and members of the public alleging misconduct by an official of FDA. It also contains reports of investigations to resolve allegations of misconduct or violations of statutes, with related exhibits of statements, affidavits or records obtained during the investigation; reports of action taken by management; decisions on any misconduct substantiated by the investigation; and reports of legal action resulting from violations of statutes referred for prosecution.

Authority for maintenance of the system:

5 U.S.C. 301; Title 18, U.S.C. (e.g., 18 U.S.C. 201, 203, 207, 208, 209, 1905); 21 U.S.C. 331; 28 U.S.C. 535(b); 44 U.S.C. 3101; E.0. 10450 and 45 CFR part 73.


To provide management with information needed to take actions against complaints or alleged violations. These complaints may be referred to the Office of Inspector General, Office of the Secretary, HHS.

Routine uses of records maintained in the system, including categories of users and the purposes of such uses: 1

1. Records that indicate violation or potential violation of law regulation and/or policy may be: (1) Referred for investigation and possible enforcement action under the applicable Federal, state, or foreign laws to the Department of Justice; an appropriate state food and drug enforcement health agency or licensing authority; or

the government of a foreign country; or (2) disclosed in administrative or court proceedings in determining whether a record is relevant to an agency decision concerning documents of investigatory materials.

2. Disclosure may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.

3. The Department of Health and Human Services (HHS) may disclose information from this system of records to the Department of Justice, or to a court or other tribunal, when

(a) HHS, or any component thereof; or

(b) Any HHS employee in his or her official capacity; or

(c) Any HHS employee in his or her individual capacity where the Department of Justice (or HHS, where it is authorized to do so) has agreed to represent the employee; or

(d) The United States or any agency thereof where HHS determines that the litigation is likely to affect HHS or any of its components,

is a party to litigation or has an interest in such litigation, and HHS determines that the use of such records by the Department of Justice, the court or other tribunal, is relevant and necessary to the litigation and would help in the effective representation of the governmental party, provided, however, that in each case, HHS determines that such disclosure is compatible with the purpose for which the records were collected.

4. Disclosure may be made to appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department’s efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, and the information disclosed is relevant and necessary for that assistance.

5. Disclosure may be made to the National Archives and Records Administration and/or the General Services Administration for the purpose of records management inspections conducted under authority of 44 U.S.C. 2904 and 2906.

6. Disclosure may be made to contractors and other persons who perform services for the agency related to this system of records and who need access to the records to perform those services. Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a.

7. When a record on its face, or in conjunction with other records, indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, disclosure may be made to the appropriate public authority, whether federal, foreign, state, local, or tribal, or otherwise, responsible for enforcing, investigating or prosecuting such violation, if the information disclosed is relevant to the responsibilities of the agency or public authority.

8. In the event HHS/FDA deems it desirable or necessary, in determining whether particular records are required to be disclosed under the Freedom of Information Act, disclosure may be made to the Department of Justice for the purpose of obtaining its advice.

Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:


Paper and automated records, in folders, in file cabinets, and on FDA central computer.


Alphabetically by name.


1. Authorized users: Limited access to Division of Ethics and Program Integrity Staff and authorized support staff of the Office of Management and Operations.

2. Physical safeguards: Records are maintained in locked rooms within a locked secured area protected by a 24-hour building guard service.

3. Procedural safeguards: Users of personal information in connection with the performance of their jobs have been instructed to protect such information from public view and from unauthorized personnel. Access is strictly limited to those employees trained in accordance with the Privacy Act. Access to computer records is via user passwords and system access codes.

4. Implementation guidelines: Safeguards are established in accordance with Chapters 45–13 of the Department's General Administration Manual.

Retention and disposal:

Records are retained until 5 years after termination of employment of subject individual or when no longer needed for reference. Disposal of records is accomplished by shredding, burning, or other appropriate means so as to render them illegible.

System manager(s) and address:

Special Agent in Charge, Office of Internal Affairs (HFD-9), Office of the Commissioner, 1801 Rockville, MD 20852.

Notification procedure:

An individual may learn if a record exists about him or her upon written request, with notarized signature if request is made by mail, or with identification if request is made in person, directed to: 

FDA Privacy Act Coordinator (HFI–30), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857

Record access procedures:

Same as notification procedure. Requesters should also reasonably specify the record contents being sought. Access to record systems which have been granted an exemption from the Privacy Act access requirement may be made at the discretion of the system manager. If access is denied to requested records an appeal may be made to: 

Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857

You may also request an accounting of disclosures that have been made of your record, if any.

Contesting record procedures:

If access has been granted, contact the official at the address specified under notification procedure above and reasonably identify the record, specify the information being contested, the corrective action sought, and your reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant.

Record source categories:

Information in this system of records is obtained from FDA personnel and FDA records, subjects of investigations, complaints, witnesses, other Federal agencies, State and local agencies, and personal observations by the investigator.

Systems exempted from certain provisions of the act:2

This system is exempt from access and contest and certain other provisions of the Privacy Act, (5 U.S.C. 552a(c)(3), (d) (1) to (4), (e)(3), (e)(4) (G) to (H), and (f)), to the extent that it includes investigatory material compiled for law enforcement purposes, including criminal law enforcement.


 1 In a June 27, 2014 Federal Register Notice FDA added certain standard routine uses to this and other FDA SORNs. The Federal Register Notice of this action describes the routine uses in more detail and is available online at http://www.gpo.gov/fdsys/pkg/FR-2014-06-27/pdf/2014-15022.pdf. The routine uses added to this SORN appear as routine uses number 4 through 8 below.

2 Federal Register notices regarding the exemptions for this system are available online: Notice of Proposed Rulemaking and Final Rule.

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