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U.S. Department of Health and Human Services

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Freedom of Information

09-10-0008 Radiation Protection Program Personnel Monitoring System, HHS/FDA/CDRH

System name:

Radiation Protection Program Personnel Monitoring System, HHS/FDA/CDRH.

Security classification:

None.

System location:

Office of Health Physics (HFZ–60), Center for Devices and Radiological Health, 5600 Fishers Lane, Rockville, MD 20857

Radiation Detection Company, 162 Wolfe Road, PO Box 3414, Sunnyvale, CA 94088

Categories of individuals covered by the system:

U.S. Public Health Service and other personnel in clinics, laboratories, hospitals, research facilities, etc., who work with ionizing radiation sources and are required to be monitored by Nuclear Regulatory Commission or Occupational Safety and Health Administration regulations.

Categories of records in the system:

Contains name, date of birth, social security account number, job code, period of exposure, effective date, and radiation exposure value.

Authority for maintenance of the system:

Atomic Energy Act of 1954 (68 Stat. 919 et seq.), Nuclear Regulatory Commission Regulations, 10 CFR part 20; Occupational Safety and Health Act of 1970 (84 Stat. 1590 et seq.), Occupational Safety and Health Administration Regulations, 29 CFR 1910.96.

Purpose(s):

To monitor incremental and accumulated exposure to ionizing radiation for radiation protection purposes.

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

Results are disclosed to employers, i.e., clinics, laboratories, etc., after the end of each monitoring period.

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.

Disclosure may be made to HHS contractors and their staff in order to accomplish the purpose for which the records are collected. The recipients are required to protect such records from improper disclosure.

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.

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

Storage:

Maintained on magnetic disc computer data bank, with back-up stored securely off-site. Hard copies are maintained in letter-size folders.

Retrievability:

Indexed by name, social security account number, and facility.

Safeguards:

1. Authorized users: Authorized CDRH and contractor personnel who must have access to information in the system in the performance of their duties.

2. Physical safeguards: Hard copies are filed in secured files, locked building with controlling security personnel stationed at key access points to the record area.

3. Procedural (or technical) safeguards: Computer software is password protected and access is restricted by Resource Access Control Facility (RACF). Contractor is required to maintain confidentiality safeguards with respect to these records.

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:

Indefinite retention on magnetic disc.

System manager(s) and address:

Program Manager, U.S.P.H.S. Personnel Monitoring Program, Office of Health Physics (HFZ–60), Center for Devices and Radiological Health, 5600 Fishers Lane, Rockville, MD 20857.

Notification procedure:

An individual may learn of his or her record 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.