[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Notices]
[Pages 4438-4440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-33007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


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

AGENCY: Divisions of Tuberculosis Elimination, National Center for HIV, 
STD and TB Prevention (NCHSTP), Centers for Disease Control and 
Prevention (CDC), Department of Health and Human Services (DHHS).

ACTION: Notification of Proposed Altered System of Records.

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SUMMARY: The Department of Health and Human Services proposes to alter 
System of Records, 09-20-0089, ``Studies of Treatment of Tuberculosis 
and other Mycobacterioses HHS/CDC/NCHSTP.'' 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 Division of Tuberculosis 
Elimination, National Center for HIV, STD and TB Prevention (NCHSTP).

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 NCHSTP receives comments that would 
result in a contrary determination.

ADDRESSES:  You may submit comments, identified by the Privacy Act 
System of Records Number 09-20-0089:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     E-mail: Include PA SOR number 09-20-0089 in the subject 
line of the message.
     Phone: 770/488-8660 (not a toll-free number).
     Fax: 770/488-8659.
     Mail: HHS/CDC Senior Official for Privacy (SOP), Office of 
the Chief Information Security Officer (OCISO), 4770 Buford Highway--M/
S: F-35, Chamblee, GA 30341.
     Hand Delivery/Courier: HHS/CDC Senior Official for Privacy 
(SOP), Office of the Chief Information Security Officer

[[Page 4439]]

(OCISO), 4770 Buford Highway--M/S: F-35, Chamblee, GA 30341.
     Comments received will be available for inspection and 
copying at this same address from 9 a.m. to 3 p.m., Monday through 
Friday, Federal holidays excepted.

SUPPLEMENTARY INFORMATION: NCHSTP proposes to alter System of Records, 
No. 09-20-0089, ``Studies of Treatment of Tuberculosis and other 
Mycobacterioses. HHS/CDC/NCHSTP.'' This System of Records will be used 
to: Determine the effectiveness and safety of a variety of treatments 
and preventive measures for tuberculosis and other mycobacterial 
diseases, determine the best measures against drug resistant 
tuberculosis, and monitor incidence of complications among individuals 
who have received preventive therapy, including isoniazid. 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 preventive therapy with 
isoniazid therapy and/or other changes 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.
    This System of Records 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.

    Dated: November 23, 2010.
Thomas P. Madden,
Chief Information Security Officer, Centers for Disease Control and 
Prevention.

    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 HIV, STD and TB Prevention (NCHSTP)

Studies of Treatment of Tuberculosis and Other Mycobacterioses--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. 09-20-0089, ``Studies of Treatment of 
Tuberculosis and other Mycobacterioses, HHS/CDC/NCHSTP.'' 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

    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.

II. Authority for Maintenance of the System

    The statutory authority for this system is given under the Public 
Health Service Act, Section 301, ``Research and Investigation'' (42 
U.S.C. 241).

III. Proposed Routine Use Disclosures of Data in the System

    A. 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:
    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

[[Page 4440]]

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 first routine use permits an individual may learn if a record 
exists about himself or herself is 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, computer 
tapes/disks, and CD-ROMs.
    The records have the following safeguards in place:
    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: Access to the CDC Clifton Road facility where 
the mainframe computer is located is controlled by a cardkey system. 
Access to the computer room is controlled by a cardkey and security 
code (numeric keypad) system. Access to the data entry area is also 
controlled by a cardkey system. The hard copy records are kept in 
locked cabinets in locked rooms. The local fire department is located 
nearby. 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 fireproof safe. Security guard 
service in buildings provides personnel screening of visitors.
    Procedural Safeguards: Protection for computerized records both on 
the mainframe and the National Center Local Area Network (LAN) include 
programmed verification of valid user identification code and password 
prior to logging on to the system, changed 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 for backup files. To avoid 
inadvertent data disclosure, ``degaussing'' 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: These practices are in compliance with 
the safeguards outlined above are 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 Center 
LAN 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 
accordance with the CDC Records Control Schedule. Records are 
maintained in agency for five years. Disposal methods include erasing 
computer tapes and 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: ``Studies of Treatment of Tuberculosis and other 
Mycobacterioses, HHS/CDC/NCHSTP.''
    B. OMB Control Number: 09-20-0089.
    C. 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.

[FR Doc. 2010-33007 Filed 1-24-11; 8:45 am]
BILLING CODE 4163-18-P