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U.S. Department of Health and Human Services

Regulatory Information

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Freedom of Information

09-10-0003 FDA Credential Holder File, HHS/FDA/OC

System name:

FDA Credential Holder File, HHS/FDA/OC.

Security classification:

None.

System location:

FDA employees: 

Personnel Property Management Section, (HFA–227), Office of Management, 5600 Fishers Lane, Rockville, MD 20857

Metropolitan Office Services Section (HFA–216), Office of Management, 200 C Street, SW, Washington, DC 20204

Division of Field Investigations (HFC–130), Office of Regulatory Affairs, 5600 Fishers Lane, Rockville, MD 20857 

Administrative Branch at Field/District Offices. For the location of Field/District Offices, see appendix A to system notice 09–10–0002, Regulated Industry Employee Enforcement Records, HHS/FDA/OC.

State and Local Employees: Division of Federal-State Relations (HFC–151), 5600 Fishers Lane, Rockville, MD 20857.

Administrative Branch at Field/District Offices. For the location of Field/District Offices, see appendix A to system notice 09–10–0002, Regulated Industry Employee Enforcement Records, HHS/FDA/OC.

Categories of individuals covered by the system:

FDA employees and state and local government employees who have been issued FDA credentials for enforcement activities.

Categories of records in the system:

Contains name, job title, height, weight, color of eyes and hair, duty status, and for state and local government employees, professional qualifications.

Authority for maintenance of the system:

Sections 702 to 704, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 372 to 374).

Purpose(s):

To issue or reissue credentials which are used to gain entry to regulated establishments.

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

1. Information may be disclosed to provide assurance to regulated enterprises that an individual is a duly designated enforcement officer and, in the case of state employees, an officer commissioned as an officer of the Department.

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:

Storage:

Maintained in file folders and on computer tapes.

Retrievability:

Indexed by name.

Safeguards:

1. Authorized users: Administrative Services Branch and Office of Regulatory Affairs personnel.

2. Physical safeguards: Records are kept in locked cabinets in a secured area, locked rooms, locked buildings and limited access to authorized personnel. Computer tapes and discs are stored in locked safe.

3. Procedural (or technical) safeguards: Computer software providing restricted commands.

4. Implementation guidelines: Safeguards are established in accordance with Chapter 45–13 and PHS hf:45–13 of the Department's General Administration Manual and Part 6 of the Department's ADP Systems Manual.

Retention and disposal:

Records are retained as long as individual is a duly designated or commissioned official; inactive files destroyed after 10 years. The records are destroyed by shredding, burning, or other appropriate means so as to render them illegible.

System manager(s) and address:

FDA employees: 

Chief, Services Unit (HFA–227), Office of Management, 5600 Fishers Lane, Rockville, MD 20857

Chief, Metropolitan Office Services Unit (HFA–216), Office of Management, 200 C Street, SW, Washington, DC 20204

Administrative Branch at Field/District Offices. For the location of Field /District Offices, see appendix A to system notice 09–10–0002, Regulated Industry Employee Enforcement Records, HHS/FDA/OC.

Federal-State Officer at Field/District Offices. For the location of Field/District Offices, see appendix A to system notice 09–10–0002, Regulated Industry Employee Enforcement Records, HHS/FDA/OMO/DMS.

State employees:

Director, Division of Federal-State Relations (HFC–151), 5600 Fishers Lane, Rockville, MD 20857.

Administrative Branch at Field/District Offices. For the location of Field/District Offices, see appendix A to system notice 09–10–0002, Regulated Industry Employee Enforcement Records, HHS/FDA/OC.

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

Contesting record procedures:

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:

Individual on whom the record is maintained.

Systems exempted from certain provisions of the act:

None.

______________________ 

 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.