[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Notices]
[Pages 4471-4474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-33023]


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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: Division of Respiratory Disease Studies (DRDS), National 
Institute for Occupational Safety and Health (NIOSH), 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, 09-20-0154, ``Medical and Laboratory Studies, HHS/
CDC/NIOSH.'' HHS is proposing to add the following Breach Response 
Routine Use Language to comply with the Office of Management and Budget 
(OMB)

[[Page 4472]]

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 Institute for 
Occupational Safety and Health (NIOSH).

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 NIOSH receives comments that would 
result in a contrary determination.

ADDRESSES: You may submit comments, identified by the Privacy Act 
System of Record Number 09-20-0154:
     Federal eRulemaking Portal: http://regulations.gov. Follow 
the instructions for submitting comments.
     E-mail: Include PA SOR number 09-20-0154 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 (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: NIOSH proposes to alter System of Records, 
No. 09-20-0154, ``Medical and Laboratory Studies, HHS/CDC/NIOSH.'' The 
purpose of this system is to perform medical and epidemiological 
research, statistical analysis, and to identify early indicators of 
occupationally related diseases (biochemical indices); data is given to 
other NIOSH units for biochemical and epidemiological studies.
    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 Institute for Occupational Safety and Health (NIOSH)

Medical and Laboratory Studies

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. 09-20-0154 ``Medical and Laboratory Studies, 
HHS/CDC/NIOSH.'' 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 purpose of this system is to perform medical and 
epidemiological research, statistical analysis, and to identify early 
indicators of occupationally related diseases (biochemical indices); 
data is given to other NIOSH units for biochemical and epidemiological 
studies.

II. Authority for Maintenance of the System

    Federal Mine Safety and Health Act of 1977, Section 501, 
``Research'' (30 U.S.C. 951); and the Occupational Safety and Health 
Act, Section 20, ``Research and Related Activities'' and Section 22(d), 
``Authority of Director, National Institute for Occupational Safety and 
Health'' (29 U.S.C. 669, 671 (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 and support the agency's mission:
    Data may be sent to State Vital Statistics Divisions to obtain 
death certificates and to missing person location agencies to find 
those individuals who cannot otherwise be located.
    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 subject to the Privacy Act are disclosed to private firms 
for data entry, computer systems analysis and computer programming 
services. The contractors promptly return data entry records after the 
contracted work is completed. The contractors are required to maintain 
Privacy Act safeguards.
    Certain communicable diseases may be reported to State and/or local 
health departments where the State has a legally constituted reporting 
program for communicable diseases and which provides for the 
confidentiality of the information.
    In the event of litigation initiated at the request of NIOSH, the 
Institute may disclose such records as it deems

[[Page 4473]]

desirable or necessary to the Department of Justice and to the 
Department of Labor, Office of the Solicitor, where appropriate, to 
enable the Departments to effectively represent the Institute, provided 
such disclosure is compatible with the purpose for which the records 
were collected. The only types of litigative proceedings that NIOSH is 
authorized to request are: (1) enforcement of a subpoena issued to an 
employer to provide relevant information; or (2) contempt citation 
against an employer for failure to comply with a warrant obtained by 
the Institute.
    Disclosure may be made to NIOSH collaborating researchers (NIOSH 
contractors, grantees, cooperative agreement holders, or other Federal 
or State scientists) in order to accomplish the research purpose for 
which the records are collected. The collaborating researchers must 
agree in writing to comply with the confidentiality provisions of the 
Privacy Act and NIOSH must have determined that the researchers' data 
security procedures will protect confidentiality.
    Records may be disclosed by CDC in connection with public health 
activities to the Social Security Administration for sources of 
locating information to accomplish the research or program purposes 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 and support the agency's mission:
    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.
    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.
    Individuals should 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.

V. Safeguards

    The records in this System are stored in computer tapes/disks and 
printouts, CD ROMs, microfilm, microfiche, and hard copy files, and the 
records in this System are retrieved by Name and case number are the 
indices used to retrieve records from this system.
    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--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), 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 facility is monitored, and 
controlled after hours, by security guard service. Hard copy records 
are kept in locked cabinets in locked rooms. Access to the LAN computer 
room is controlled by a punch lock system. The local fire department is 
one mile from the facility, which is of structural steel and cement 
block construction, with pre-cast cement panels on the envelope. No 
combustible materials are used in the building construction, including 
all interior walls. Heat sensors are installed, and portable fire 
extinguishers are located throughout the computer room. The active 
system files are backed up on a weekly basis. The entire system is 
backed up, with copies of the files stored in a secure, fireproof safe 
in a separate location within the facility.
    Procedural Safeguards--The NIOSH Local Area Network (LAN) computer 
system, located within the Morgantown facility, uses a security package 
to control unauthorized access to the system. Attempts to gain access 
by unauthorized individuals are automatically recorded and reviewed on 
a daily basis. Protection for computerized records both on the 
mainframe and the NIOSH 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 are routine daily backup procedures and secure off-site 
storage is available for backup tapes. 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 in 
accordance with the 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 
NIOSH 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 the 
following way: Master records for completed studies are maintained in 
agency until transferred to the National Archives. Source documents for

[[Page 4474]]

computer data are disposed of when no longer needed in the study, as 
determined by the system manager, and as provided in the signed consent 
form, as appropriate. 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. Electronic records, if any, are maintained according to the 
provisions of the records control schedule for NIOSH electronic 
records, which is consistent with the records maintenance requirements 
for other forms of records. Copies of notifications to workers/private 
physicians of needed medical attention and/or medical treatment are 
destroyed when no longer needed for administrative purposes, but may be 
retained for as long as seventy (70) years. Paper records are 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: ``Medical and Laboratory Studies, HHS/CDC/NIOSH.''
    OMB Control Number: 09-20-0154.
    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. 2010-33023 Filed 1-24-11; 8:45 am]
BILLING CODE 4163-18-P