Privacy Act of 1974; Report of Modified or Altered System of Records

AGENCY:

National Center for Infectious Diseases (NCID), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS).

ACTION:

Notification of Proposed Altered System of Records.

SUMMARY:

The Department of Health and Human Services proposes to alter System of Records, 09-20-0113, “Epidemic Investigation Case Records, HHS/CDC/NCID.” HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information:

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.

These records will be maintained by the National Center for Infectious Diseases (NCID).

DATES:

Comments must be received on or before February 24, 2011. The proposed altered System of Records will be effective 40 days from the date submitted to the OMB, unless NCID receives comments that would result in a contrary determination.

ADDRESSES:

You may submit comments, identified by the Privacy Act System of Record Number 09-20-0113:

SUPPLEMENTARY INFORMATION:

NCID proposes to alter System of Records, No. 09-20-0113, “Epidemic Investigation Case Records, HHS/CDC/NCID.” The record system is used by professional staff at the Centers for Disease Control and Prevention (CDC) for more complete knowledge of the disease/condition in the following ways: (1) An examination of existing files enables investigators to determine areas that have been adequately investigated and to specify those that might be pursued; or (2) records may later be examined in the light of future discoveries and proven associations so that relevant data collected at the time of the outbreak may be analyzed and reassessed. CDC may or may not request duplicate copies of these State and/or local health department records for further analysis following completion of the field investigation.

This System of Record Notice is being altered to add the Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) memorandum dated May 22, 2007.

The following notice is written in the present tense, rather than the future tense, in order to avoid the unnecessary expenditure of public funds to republish the notice after the System has become effective.

Editorial Note:

This document was received at the Office of the Federal Register on December 27, 2010.

Department of Health and Human Services (HHS)

Centers for Disease Control and Prevention (CDC)

National Center for Infectious Diseases (NCID)

Epidemic Investigation Case Records—Report of Modified or Altered System of Records

Narrative Statement

I. Background and Purpose of the System

A. Background

The Department of Health and Human Services proposes to alter System of Records, No. 09-20-0113 “Epidemic Investigation Case Records, HHS/CDC/NCID.” HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information:

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.

B. Purpose

The record system is used by professional staff at the Centers for Disease Control and Prevention (CDC) for more complete knowledge of the disease/condition in the following ways: (1) An examination of existing files enables investigators to determine areas that have been adequately investigated and to specify those that might be pursued; or (2) Records may later be examined in the light of future discoveries and proven associations so that relevant data collected at the time of the outbreak may be analyzed and reassessed. CDC may or may not request duplicate copies of these State and/or local health department records for further analysis following completion of the field investigation.

II. Authority for Maintenance of the System

Public Health Service Act, Section 301, “Research and Investigation,” (42 U.S.C. 241); Sections 304, 306, and 308(d), which discuss authority to maintain data and to provide assurances of confidentiality for health research and related activities (42 U.S.C. 242b, 242k, and 242m(d)); and Section 361, “Quarantine and Inspection, Control of Communicable Diseases,” (42 U.S.C. 264).

III. Proposed Routine Use Disclosures of Data in the System

The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use”. The routine uses proposed for this System are compatible with the stated purpose of the System:

The following routine uses apply to all records in this system except those maintained under an assurance of confidentiality provided by Section 308(d) of the Public Health Service Act (unless expressly authorized in the consent form or stipulated in the Assurance Statement):

These records may be disclosed, i.e., returned to the State and/or local health departments in order for them to take measures to control, prevent, or treat disease and to conduct follow-up activities with patients and others contacted during the investigations. Private physicians may also be supplied pertinent medical information on their patients from these 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.

In the event of litigation where the defendant is: (a) The Department, any component of the Department, or any employee of the Department in his or her official capacity; (b) the United States where the Department determines that the claim, if successful, is likely to directly affect the operations of the Department or any of its components; or (c) any Department employee in his or her individual capacity where the Department of Justice has agreed to represent such employee, for example, in defending a claim against the Public Health Service based upon an individual's mental or physical condition and alleged to have arisen because of activities of the Public Health Service in connection with such individual, disclosure may be made to the Department of Justice to enable that Department to present an effective defense, provided that such disclosure is compatible with the purpose for which the records were collected.

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.

IV. Effects of the Proposed System of Records on Individual Rights

The routine uses proposed for this System are compatible with the stated purpose of the System:

The first routine use permits 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 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.

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.

V. Safeguards

The records in this System are stored in file folders. Service fellow personnel data is also maintained in an automated database. The records in this System are retrieved by the name of the individual, fellow, or guest researcher.

The records in this System have the following safeguards in place to maintain and protect the information as it relates to Authorized users, physical and procedural safeguards:

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 and Prevention (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.

Physical Safeguards—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 and Prevention (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.

Procedural Safeguards—Protection for computerized records both on the mainframe and the National Centers' Local Area Networks (LAN)s includes programmed verification of valid user identification code and password prior to logging on to the system, mandatory password changes, limited log-ins, virus protection, and user rights/file attribute restrictions. Password protection imposes user name and password log-in requirements to prevent unauthorized access. Each user name is assigned limited access rights to files and directories at varying levels to control file sharing. There are routine daily backup procedures and secure off-site storage is available. To avoid inadvertent data disclosure, “an additional procedure” is performed to ensure that all data are removed from Privacy Act computer tapes and/or other magnetic media. 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.

Implementation Guidelines: The safeguards outlined above in accordance with the HHS Information Security Program Policy and FIPS Pub 200, “Minimum Security Requirements for Federal Information and Information Systems.” Data maintained on CDC's Mainframe and the National Centers' LANs are in compliance with OMB Circular A-130, Appendix III. Security is provided for information collection, processing, transmission, storage, and dissemination in general support systems and major applications.

The records in this System are retained and disposed of in the following way: Records are retained and disposed of in accordance with the CDC Records Control Schedule. Records are maintained in agency for four years. Disposal methods include erasing computer media, 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.

VI. OMB Control Numbers, Expiration Dates, and Titles of Information Collection

A. Full Title: “Epidemic Investigation Case Records, HHS/CDC/NCID.”

OMB Control Number: 09-20-0113.

Expiration Date: TBD.

VII. Supporting Documentation

A. Preamble and Proposed Notice of System for publication in the Federal Register.

B. Agency Rules: None.

C. Exemption Requested: None.

D. Computer Matching Report: The new system does not require a matching report in accordance with the computer matching provisions of the Privacy Act.