09-10-0004 Communications (Oral and Written) With the Public, HHS/FDA/OC
Communications (Oral and Written) With the Public, HHS/FDA/OC.
Administrative Services Branch (HFA–210), 5600 Fishers Lane, Rockville, MD 20857
Office of Legislative Affairs (HFW–1), 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/OMO/DMS.
For the location of Federal Archives and Records Centers, see appendix B to system notice 09–10–0002, Regulated Industry Employee Enforcement Records, HHS/FDA/OMO/DMS.
Categories of individuals covered by the system:
Individuals, other than employees of enterprises regulated by FDA, who communicate with FDA or, in some cases, are the subject of communications by others with FDA.
Categories of records in the system:
Includes correspondence from and to individuals, summaries of conversations prepared by FDA employees, and records prepared by FDA as a follow-up to consumer complaints, oral and written. Administrative Services Branch files include copies of correspondence received from the public, and the FDA reply. The Office of Legislative Affairs maintains duplicates of letters FDA sends to members of Congress and summaries of oral inquiries in files organized by members' names. The Office of Legislative Affairs maintains a manual control system and the Executive Secretariat, Office of the Commissioner, maintains an automated control system of pending correspondence requiring a reply.
Authority for maintenance of the system:
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.); the Public Health Service Act (42 U.S.C. 201 et seq.), and authority delegated to the Commissioner (21 CFR 5.1).
To aid FDA employees in carrying out their responsibilities, e.g., responding to follow-up correspondence on complaints, requests for information, etc.
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:
Manual records are maintained in letter-size folders. Automated records are maintained on computer tapes and discs and stored in a locked safe.
Records are arranged by company or by subject. A computer index gives correspondent's name, date of letter, subject, and location. Field offices file consumer complaints by complaint number.
1. Authorized users: FDA employees who display an FDA identification card; GAO employees upon approval of GAO Liaison Officer, Operations Coordination Staff, OMO, employees of DHHS agencies other than FDA whose duties require the use of information in the system.
2. Physical safeguards: Records are stored in locked cabinets in secured areas, locked buildings and locked rooms. Computer tapes and discs are stored in a locked safe.
3. Procedural (or technical) safeguards: Computer software providing restricted commands. Employees of DHHS agencies other than FDA must display government identification card, complete agreement between FDA and the agency concerned, and sign a commitment to protect privileged information.
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 may be retired to a Federal Records Center and subsequently disposed of in accordance with FDA's Records Control Schedule. The Records Control Schedule and disposal standard for these records may be obtained by writing to the system manager at the appropriate address below.
System manager(s) and address:
Chief, Administrative Services Branch (HFA–210), 5600 Fishers Lane, Rockville, MD 20857
Office of Legislative Affairs (HFW–1), 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/OMO/DMS.
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 specify the record, 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 or others (generally members of Congress) who write to FDA about them.
Systems exempted from certain provisions of the act:
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.