[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Notices]
[Pages 4432-4435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-33004]
[[Page 4431]]
Vol. 76
Tuesday,
No. 16
January 25, 2011
Part II
Department of Health and Human Services
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Centers for Disease Control and Prevention
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Privacy Act of 1974; Report of Modified or Altered System of Records;
Notices
Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 /
Notices
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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: 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, 09-19-0001, ``Records of Persons Exposed or
Potentially Exposed to Toxic or Hazardous Substances, HHS/ATSDR.'' 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 Agency for Toxic Substances
and Disease Registry (ATSDR), Coordinating Center for Environmental
Health and Injury Prevention (CCEHIP), Division of Health Studies.
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 ATSDR/CCEHIP receives comments that
would result in a contrary determination.
ADDRESSES: You may submit comments, identified by the Privacy Act
System of Record Number 09-19-0001:
Federal eRulemaking Portal: http://regulations.gov. Follow
the instructions for submitting comments.
E-mail: Include PA SOR number 09-19-0001 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: ATSDR/CCEHIP proposes to alter System of
Records, No. 09-19-0001, ``Records of Persons Exposed or Potentially
Exposed to Toxic or Hazardous Substances, HHS/ATSDR.'' Records in this
system are used to carry out the legislated environmental public health
mandates of the Agency for Toxic Substances and Disease Registry
(ATSDR). Specifically this information is used to: (1) Identify the
public health threat caused by exposure to toxic and hazardous
substances utilizing health outcome studies, epidemiologic studies,
exposure investigations, and other health effects studies; and (2)
establish and maintain national registries of persons exposed to toxic
substances and persons with serious diseases and illnesses associated
or potentially associated with exposure to toxic substances. Registries
will have the additional purposes of tracking exposed individuals,
keeping them informed of health effects of exposure, preventive
measures and possible breakthroughs in treatment, along with serving as
a centralized location for research data on these exposed individuals.
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.
SYSTEM NUMBER: 09-19-0001
SYSTEM NAME:
Records of Persons Exposed or Potentially Exposed to Toxic or
Hazardous Substances, HHS/ATSDR.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Division of Health Studies, Agency for Toxic Substances and Disease
Registry (ATSDR), Coordinating Center for Environmental Health and
Injury Prevention (CCEHIP), 4770 Buford Highway, Building 106, Atlanta,
GA 30341,
Division of Health Assessment and Consultation, ATSDR, CCEHIP, 4770
Buford Highway, Building 106, Atlanta, GA 30341,
Division of Regional Operations, ATSDR, CCEHIP, 4770 Buford
Highway, Building 106, Atlanta, GA 30341,
Division of Toxicology and Environmental Medicine, ATSDR, CCEHIP,
4770 Buford Highway, Building 106, Atlanta, GA 30341-3724; and
Federal Records Center, 4712 Southpark Blvd., Ellenwood, GA 30294.
Data are also located at contractor sites. A list of contractor sites
where individually identified data are currently located is available
upon request to the system manager.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Individuals exposed or potentially exposed to toxic or hazardous
substances may include the following: (1) Selected persons living or
having lived near a hazardous waste site, including facilities owned or
operated by the United States; (2) persons exposed or potentially
exposed to environmental hazards resulting from exposure to
contaminated water, soil, air, or biota; (3) participants in health
outcome studies (including exposure studies, symptom and disease
prevalence studies, cluster investigations), and epidemiologic studies
to determine the public health threat of exposure to hazardous or toxic
substances; (4) registry participants with exposures associated with
specific chemicals; (5) participants from sites of emergency
activities, and other sites that are the subject of a citizen's
petition; (6) persons working or having worked in response actions at
hazardous waste sites or other occupational settings where exposure to
hazardous substances occurred. The first five categories of persons
above may include children as well as adults.
CATEGORIES OF RECORDS IN THE SYSTEM:
Name, address, (including length of time at current address),
telephone number, date of birth, Social Security number, sex, current
and past occupations, dates, pathways and routes of toxic or hazardous
substance exposure or potential exposure, environmental sampling data,
smoking history, results of medical and laboratory tests, records on
biological specimens (e.g. blood, urine, etc.), and related documents
such as
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questionnaire responses. The specific type of records collected and
maintained is determined by the needs of the individual registry or
study.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
``Comprehensive Environmental Response, Compensation, and Liability
Act of 1980'' as amended by ``Superfund Amendments and Reauthorization
Act of 1986'' (42 U.S.C. 9601, 9604); and the ``Resource Conservation
and Recovery Act of 1976'' as amended in 1984 (42 U.S.C. 6901).
PURPOSE(S):
Records in this system are used to carry out the legislated
environmental public health mandates of the Agency for Toxic Substances
and Disease Registry (ATSDR). Specifically this information is used to:
(1) Identify the public health threat caused by exposure to toxic and
hazardous substances utilizing health outcome studies, epidemiologic
studies, exposure investigations, and other health effects studies; and
(2) establish and maintain national registries of persons exposed to
toxic substances and persons with serious diseases and illnesses
associated or potentially associated with exposure to toxic substances.
Registries will have the additional purposes of tracking exposed
individuals, keeping them informed of health effects of exposure,
preventive measures and possible breakthroughs in treatment, along with
serving as a centralized location for research data on these exposed
individuals.
Records may be disclosed to the National Center for Environmental
Health, CCEHIP, and Centers for Disease Control and Prevention (CDC),
for laboratory analysis of samples and for collaborative efforts (i.e.,
providing staff, performing statistical analysis, etc.) in coordinating
investigations.
Records (i.e., name, Social Security number, date of birth) may be
disclosed to the National Center for Health Statistics, CDC to obtain a
determination of vital status. Death certificates with the cause of
death will then be obtained from Federal, State, or local agencies to
enable ATSDR to: (1) Determine whether excess mortality is occurring
among individuals exposed to toxic or hazardous substances; and (2)
notify similarly exposed persons.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
Records may be disclosed to Department of Health and Human Services
contractors to locate individuals exposed or potentially exposed to
toxic or hazardous substances (e.g., in the establishment of the
National Exposure Registry), conduct interviews, perform medical
examinations, collect and analyze biological specimens, evaluate and
interpret data, and perform follow up health investigations so that the
research purposes for which the records are collected may be
accomplished. The contractor must comply with the requirements of the
Privacy Act with respect to such records.
Records may be disclosed to Federal agencies such as the
Environmental Protection Agency (EPA), State and local health
departments, and other public health or cooperating medical authorities
in connection with program activities and related collaborative efforts
to deal more effectively with exposures to hazardous or toxic
substances, and to satisfy mandatory reporting requirements when
applicable.
Records (i.e., name, Social Security number) may be disclosed to
other Federal agencies and to missing person location agencies to
obtain information to aid in locating individuals involved in these
studies.
Records 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 identified 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; and (D) has secured a written
statement attesting to the recipient's understanding of, and
willingness to abide by these provisions.
Disclosures may be made to a congressional office from the records
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 initiated by EPA in collaboration with
ATSDR, ATSDR may disclose such records as it deems desirable or
necessary to the Department of Justice to enable the Department to
effectively represent ATSDR. The types of litigative proceedings that
ATSDR may request include the recovery of expenses incurred in cleanup
operations at Superfund or Resource Conservation and Recovery Act
sites, including program and staff costs.
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 claims, if successful, are 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 provided to the Social Security Administration by
ATSDR, for the purpose of locating or tracking individuals, to
accomplish the research or program 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.
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POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
File folders, computer tapes and disks (hard and floppy), CD-ROMs.
RETRIEVABILITY:
By name or Social Security number.
SAFEGUARDS:
The following special safeguards are provided to protect the
records from inadvertent disclosure:
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 to records is granted
to only a limited number of physicians, scientists, statisticians, and
designated support staff of ATSDR or its contractors, as authorized by
the system manager to accomplish the stated purposes for which the data
in this system have been collected. A list of authorized users will be
maintained by the system manager.
Physical Safeguards: Questionnaires, log books, and other source
data are maintained in locked cabinets in locked rooms, and security
guard service in buildings provide personnel screening of visitors.
Access to the CDC Clifton Road facility where the mainframe computer is
located (ATSDR utilizes the CDC mainframe computer) is controlled by a
cardkey system. Access to the computer room is controlled by a cardkey
and security code (numeric keypad) system. The local fire department is
located directly next door to the Clifton Road facility. The computer
room is protected by an automatic sprinkler system, numerous automatic
sensors (e.g., water, heat, smoke, etc.) are installed, and a proper
mix of portable fire extinguishers is 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. Computer
workstations, lockable personal computers, and automated records are
located in secured areas.
Procedural Safeguards: Protection for computerized records both on
the mainframe and the ATSDR 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 files.
Knowledge of individual tape passwords is required to access tapes,
and access to systems is limited to users obtaining prior supervisory
approval. When Privacy Act tapes are scratched, a special ``an
additional procedure'' process is performed in which tapes are
completely written over to avoid inadvertent data disclosure. When
possible, a backup copy of data is stored at an offsite location and a
log kept of all changes to each file and all persons reviewing the
file. Selected safeguards will be applicable to specific elements of
the system, as appropriate. Additional safeguards may also be built
into the program by the system analyst as warranted by the sensitivity
of the specific data set.
ATSDR and contractor employees who maintain records are instructed
in specific procedures to protect the security of records, and are to
check with the system manager prior to making disclosure of data. When
individually identified data are being used in a room, admittance at
either ATSDR or contractor sites is restricted to specifically
authorized personnel.
Appropriate Privacy Act provisions are included in contracts, and
the ATSDR Project Director, contract officers, and project officers
oversee compliance with these requirements. Upon completion of the
contract, all data will be either returned to ATSDR or destroyed, as
specified by the contract.
Implementation Guidelines: 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 ATSDR
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.
RETENTION AND DISPOSAL:
Records are retained and disposed of in accordance with the ATSDR
Comprehensive Records Control Schedule (B-371). Current procedures
allow the system manager to keep the records for 20 years unless needed
for further study. Registry records will be actively maintained as long
as funding is provided for by legislation. Retention periods vary
depending on the type of record. Source documents for computer tapes or
disks 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.
Records may be transferred to a Federal Records Center for storage
when no longer needed for evaluation or analysis. Disposal methods
include the paper recycling process, burning or shredding hard copy
records, and erasing computer tapes and disks.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Division of Health Studies, Chamblee Bldg 106, Rm 3007,
MS F57, ATSDR, CCEHIP, 4770 Buford Highway, Atlanta, GA 30341.
Director, Division of Health Assessment and Consultation, Chamblee
Bldg 106, Rm 5007, MS F59, ATSDR, CCEHIP, 4770 Buford Highway, Atlanta,
GA 30341.
Director, Division of Regional Operations, Chamblee Bldg 106, Rm
4112, MS F58, ATSDR, CCEHIP, 4770 Buford Highway, Atlanta, GA 30341.
Director, Division of Toxicology and Environmental Medicine,
Chamblee Bldg. 101, Rm. 3118, MS F29, ATSDR, CCEHIP, 4770 Buford
Highway, Atlanta, GA 30341-3724.
NOTIFICATION PROCEDURE:
An individual may learn if a record exists about himself or herself
by contacting the appropriate system manager at the above address.
Persons who knowingly and willfully request or acquire a record
pertaining to an individual under false pretenses are subject to
criminal prosecution. Requesters in person must provide photo
identification (such as driver's license) or other positive
identification that would authenticate the identity of the individual
making the request. Individuals who do not appear in person must submit
a request which has been notarized to verify their identity. A parent
or guardian who requests notification of, or access to, a minor's
medical record must provide a birth certificate (or notarized copy),
court order, or other competent evidence of guardianship. An individual
who requests notification of or access to, a medical record shall at
the time the request is made, designate in writing a responsible
representative (who may be a physician, other health professional, or
other responsible individual) who will be willing to review the record
and inform the subject individual of its contents at the
representative's discretion.
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In addition, the following information should be provided when
requesting notification: (1) Full name and Social Security number; and
(2) nature of the study, or probable exposure or disease subregistry
which might include the requester.
RECORD ACCESS PROCEDURE:
Same as the 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.
CONTESTING RECORD PROCEDURE (REDRESS):
Contact the system manager at the address specified 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.
RECORD SOURCE CATEGORIES:
Subject individuals, families of deceased individuals, concerned
citizens associated with a particular site, State and local health
departments, physicians' records, hospital records, Social Security
Administration, Environmental Protection Agency and other agencies
responsible for environmental public health.
SYSTEM EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. 2010-33004 Filed 1-24-11; 8:45 am]
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