[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]
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