State Food and Drug Official File, HHS/FDA/ORA.
Regional Food and Drug Offices (See Appendix A 0.
Categories of individuals covered by the system:
State officials who have responsibilities related to those of the Food and Drug Administration.
Categories of records in the system:
Contains name, date of birth, education and professional experience, and state in which employed.
Authority for maintenance of the system:
Section 702(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 372(a)).
To provide FDA with the names of State officials who have responsibilities related to those of the Food and Drug Administration.
Routine uses of records maintained in the system, including categories of users and the purposes of such uses: 1
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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:
Maintained in letter-size manila folders.
Indexed by name and state.
1. Authorized users: Personnel of the Division of Federal State Relations who are engaged in contracts or any other activity involving commissioning.
2. Physical safeguards: Records are kept in locked cabinets in a secured area, locked rooms and locked building.
3. Procedural safeguards: Users of personal information in the performance of their duties have been instructed to protect personal information from public view and from unauthorized personnel. Access is strictly limited to those staff members trained in accordance with the Privacy Act.
4. Implementation guidelines: Safeguards are established in accordance with Chapter 45–13 and PHS hf:45–13 of the Department's General Administration Manual.
Retention and disposal:
Records are retained as long as individual is a state employee.
System manager(s) and address:
Regional Food and Drug Directors (See Appendix A for Address).
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. Requests should also reasonably specify the records content 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:
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 3 through 7 below.