[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]



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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:
    <bullet> Federal eRulemaking Portal: http://regulations.gov. Follow 
the instructions for submitting comments.
    <bullet> E-mail: Include PA SOR number 09-19-0001 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: 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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