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                              FOIA (Freedom of Information Act)
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                              SORN 09-20-0089
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SORN 09-20-0089








  
  
    

  
      





**System Name:**Studies of Treatment of Tuberculosis and other Mycobacterioses, HHS/CDC/NCPS.

**Security Classification:**None.

**System Location(s):**Division of Tuberculosis Elimination, National Center for Prevention Services, Corporate Square, Bldg. 10, Room 2208, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333 and Federal Records Center, 1557 St. Joseph Avenue, East Point, GA 30344.

A list of contractor sites where individually identified data are currently located is available upon request to the system manager.

**Categories of Individuals Covered by the System:**Adults and children with tuberculosis or other mycobacterial diseases having been or currently being treated or observed by a limited number of participating local or county health departments, clinics, and hospitals (from 1959 until the present time), including those individuals in selected areas receiving isoniazid therapy or BCG vaccinations, and patients for whom routine tuberculosis treatment is ineffective. Also included are contacts to tuberculosis patients, adults with inactive tuberculosis, and controls.

**Categories of Records in the System:**Abstracts of medical data pertaining to clinical trials, including medical history, skin tests, physical examinations, laboratory test results, X-ray results, medications prescribed, smoking habits, etc.

**Authority for Maintenance of the System:**Public Health Service Act, Section 301, "Research and Investigation" (42 U.S.C. 241).

**Purpose(s):**To determine the effectiveness and safety of a variety of treatments and preventive measures for tuberculosis and other mycobacterial diseases, to determine the best measures against drug resistant tuberculosis, and to monitor incidence of complications among individuals who have received preventive therapy, including isoniazid.

**Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of such Uses:**

Records may be disclosed to health departments and other public health or cooperating medical authorities in connection with program activities and related collaborative efforts to deal more effectively with diseases and conditions of public health significance.

Records may be disclosed to health departments and other public health or cooperating medical authorities in connection with program activities and related collaborative efforts to deal more effectively with diseases and conditions of public health significance.

A record may be disclosed for a research purpose, when the Department:

(A) Has determined that the use or disclosure does not violate legal or policy limitations under which the record was provided, collected, or obtained;

(B) Has determined that the research purpose (1) cannot be reasonably accomplished unless the record is provided in individually identifiable form, and (2) warrants the risk to the privacy of the individual that additional exposure of the record might bring;

(C) Has required the recipient to: (1) Establish reasonable administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of the record, (2) remove or destroy the information that identifies the individual at the earliest time at which removal or destruction can be accomplished consistent with the purpose of the research project, unless the recipient has presented adequate justification of a research or health nature for retaining such information, and (3) make no further use or disclosure of the record except (a) in emergency circumstances affecting the health or safety of any individual, (b) for use in another research project, under these same conditions, and with written authorization of the Department, (c) for disclosure to a properly identified person for the purpose of an audit related to the research project, if information that would enable research subjects to be identified is removed or destroyed at the earliest opportunity consistent with the purpose of the audit, or (d) when required by law;

(D) Has secured a written statement attesting to the recipient's understanding of, and willingness to abide by these provisions.

The Department is under contract with private firms for the purpose of collating, analyzing, aggregating or otherwise refining records in this system. Relevant records are maintained by the contractors. The contractors are required to maintain Privacy Act safeguards with respect to such records. Disclosure may be made to a congressional office from the record of an individual in response to a verified inquiry from the congressional office made at the written request of that individual.

Records may be disclosed 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 disclosed is relevant and necessary for that assistance.

**Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System—**

**Storage:**Cards, file folders, computer tapes/disks and printouts.

**Retrievability:**Records are retrieved by the participant's name and/or study I.D. number.

**Safeguards:**

1. Authorized users: A database security package is implemented on CDC's mainframe computer to control unauthorized access to the system. Attempts to gain access by unauthorized individuals are automatically recorded and reviewed on a regular basis. Access is granted to only a limited number of physicians, scientists, statisticians, and designated support staff of the Centers for Disease Control (CDC), or its contractors, as authorized by the system manager to accomplish the stated purposes for which the data in this system have been collected.

2. Physical safeguards: Access to the CDC Clifton Road facility where the mainframe computer is located is controlled by a card key system. Access to the computer room is controlled by a card key and security code (numeric keypad) system. Access to the data entry area is also controlled by a card key system. The hard copy records are kept in locked cabinets in locked rooms. The local fire department is located directly across the street from the Clifton Road buildings. The computer room is protected by an automatic sprinkler system, automatic sensors (e.g., water, heat, smoke, etc.) are installed, and portable fire extinguishers are located throughout the computer room. The system is backed up on a nightly basis with copies of the files stored off site in a secure fire proof safe. The 24-hour guard service in buildings provides screening of visitors. Electronic anti-intrusion devices are in effect at the Federal Records Center.

3. Procedural safeguards: System security includes automatic suspension of accounts, forced password changes, and control of systems and data set access. Protection for computerized records includes programmed verification of valid user identification code, account code and password prior to acceptance of a terminal session or job submission, frequently changed passwords, and Vault Management System. When Privacy Act tapes are erased, a special "certified" process is performed in which tapes are completely written over to avoid inadvertent data disclosure. Additional safeguards may be built into the program by the system analyst as warranted by the sensitivity of the data.

CDC and contractor employees who maintain records are instructed to check with the system manager prior to making disclosures of data. When individually identified data are being used in a room, admittance at either CDC or contractor sites is restricted to specifically authorized personnel. Privacy Act provisions are included in contracts, and the CDC Project Director, contract officers and project officers oversee compliance with these requirements. Upon completion of the contract, all data will be either returned to CDC or destroyed, as specified by the contract.

4. Implementation guidelines: The safeguards outlined above are developed in accordance with Chapter 45-13, "Safeguarding Records Contained in Systems of Records," of the HHS General Administration Manual, supplementary Chapter PHS.hf: 45-13; Part 6, "Automated Information System Security," of the HHS Information Resources Management Manual; the National Bureau of Standards Federal Information Processing Standards (FIPS Pub. 41 and FIPS Pub. 31). FRC safeguards are in compliance with GSA Federal Property Management Regulations, Subchapter B--Archives and Records.

**Retention and Disposal:**Records are maintained in agency for five years. Disposal methods include erasing computer tapes, burning or shredding paper materials or transferring records to the Federal Records Center when no longer needed for evaluation and analysis. Records destroyed by paper recycling process when 20 years old, unless needed for further study.

**System Manager(s) and Address(es):**Director, Division of Tuberculosis Elimination, National Center for Prevention Services, Corporate Square, Bldg. 10, Rm. 10, MS E10, Centers for Disease Control and Prevention, l600 Clifton Road, NE, Atlanta, GA 30333.

**Notification Procedure:**An individual may learn if a record exists about himself or herself by contacting the system manager at the address above. Requesters in person must provide driver's license or other positive identification. Individuals who do not appear in person must either (1) submit a notarized request to verify their identity or (2) certify that they are the individuals they claim to be and that they understand that the knowing and willful request for or acquisition of a record pertaining to an individual under false pretenses is a criminal offense under the Privacy Act subject to a 5,000 dollars fine.

An individual who requests notification of or access to medical records shall, at the time the request is made, designate in writing a responsible representative who is willing to review the record and inform the subject individual of its contents at the representative's discretion.

A parent or guardian who requests notification of, or access to, a child's medical record shall designate a family physician or other health professional (other than a family member) to whom the record, if any, will be sent. The parent or guardian must verify relationship to the child by means of a birth certificate or court order, as well as verify that he or she is who he or she claims to be.

The following information must be provided when requesting notification: (1) Full name; (2) the approximate date and place of the study, if known; and (3) nature of the questionnaire or study in which the requester participated.

**Record Access Procedures:**Same as notification procedures. Requesters should also reasonably specify the record contents being sought. An accounting of disclosures that have been made of the record, if any, may be requested.

**Contesting Record Procedures:**Contact the official at the address specified under System Manager above, reasonably identify the record and specify the information being contested, the corrective action sought, and the reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant.

**Record Source Categories:**Individuals, state and local health departments, hospitals, laboratories, clinics, and family members of study participants.

**Systems Exempted from Certain Provisions of the Act:**None.

                    
  


Content created by Freedom of Information Act (FOIA) Division Content last reviewed December 15, 2017 Back to top
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