[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Notices]
[Pages 4449-4451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-33012]



[[Page 4449]]

-----------------------------------------------------------------------

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: Scientific Resources Program, Material, Data and Specimen 
Handling Section, National Center for Infectious Diseases (NCID), 
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, 09-20-0106, ``Specimen Handling for Testing and 
Related Data, 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), Scientific Resources Program, Material, 
Data and Specimen Handling Section.

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 09-20-0106:
    <bullet> Federal eRulemaking Portal: http://regulations.gov. Follow 
the instructions for submitting comments.
    <bullet> E-mail: Include PA SOR number 09-20-0106 in the subject 
line of the message.
    <bullet> Phone: 770/488-8660 (not a toll-free number).
    <bullet> Fax: 770/488-8659.
    <bullet> 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.
    <bullet> Hand Delivery/Courier: 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.
    <bullet> 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: NCID proposes to alter System of Records, 
No. 09-20-0106, ``Specimen Handling for Testing and Related Data, HHS/
CDC/NCID.'' For documentation of test results which are returned to 
submitter. Used between specialty units for research purposes; and for 
epidemiological investigations, for epidemic causes, prevention, family 
groupings of diseases, and geographical location of specific diseases; 
also, used by epidemiologist and researchers in determining drug 
resistance of specific organisms.
    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.

    Dated: December 11, 2009.
James D. Seligman,
Chief Information 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 Infectious Diseases (NCID)

Specimen Handling for Testing and Related Data--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. 09-20-0106 ``Specimen Handling for Testing and 
Related Data, 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

    For documentation of test results which are returned to submitter. 
Used between specialty units for research purposes; and for 
epidemiological investigations, for epidemic causes, prevention, family 
groupings of diseases, and geographical location of specific diseases; 
also, used by epidemiologist and researchers in determining drug 
resistance of specific organisms.

II. Authority For Maintenance of the System

    Public Health Service Act, Section 301, ``Research and 
Investigation,'' (42 U.S.C. 241); and Sections 304, 306 and 308(d) 
which discuss authority to grant assurances of confidentiality for 
health research and related activities (42 U.S.C. 242 b, k, and m(d)).

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:
    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.
    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

[[Page 4450]]

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 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 original form (file 
folders); microfilm copies and computer tapes/disks and printouts. The 
records are retrieved by name or designated number furnished by the 
submitter, CDC identifying number, and/or microfilm number.
    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--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 
directly next door to 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 fireproof safe. The 24-hour guard service in buildings 
provides personnel screening of visitors. Electronic anti-intrusion 
devices are in effect at the Federal Records Center.
    Procedural Safeguards--Protection for computerized records both on 
the mainframe and the CIO Local Area Network (LAN) 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 is routine daily backup procedures and secure off-site 
storage is available for backup tapes. 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: 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; and Part 6, ``Automated Information System Security,'' of the 
HHS Information Resources Management Manual. FRC safeguards are in 
compliance with GSA Federal Property Management Regulations, Subchapter 
B--Archives and Records. Data maintained in CDC Atlanta's Processing 
Center 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 CIO LAN currently operates under Novell Netware 
v 4.11 and is in compliance with ``CDC & ATSDR Security Standards for 
Novell File Servers.''
    The records in this System are retained and disposed of in the 
following way: 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

[[Page 4451]]

process when 10 years old, unless needed for further study.

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

    A. Full Title: ``Specimen Handling for Testing Related Data, HHS/
CDC/NCID.''
    OMB Control Number: 09-20-0106.
    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. 2010-33012 Filed 1-24-11; 8:45 am]
BILLING CODE 4163-18-P