[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Notices]
[Pages 4483-4485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-33028]



[[Page 4483]]

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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 Select Agents and Toxins (DSAT), Coordinating 
Office for Terrorism Preparedness and Emergency Response (COTPER), 
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, 09-20-0170, National Select Agent Registry (NSAR)/
Select Agent Transfer and Entity Registration Information System 
(SATERIS), HHS/CDC/COTPER''. 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 Coordinating Office for 
Terrorism Preparedness and Emergency Response (COTPER), Division of 
Select Agents and Toxins (DSAT).

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 COTPER/DSAT receives comments that 
would result in a contrary determination.

ADDRESSES: You may submit comments, identified by the Privacy Act 
System of Record Number 09-20-0170:
     Federal eRulemaking Portal: http://regulations.gov. Follow 
the instructions for submitting comments.
     E-mail: Include PA SOR number 09-20-0170 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: COTPER/DSAT proposes to alter System of 
Records, No. 09-20-0170, ``National Select Agent Registry (NSAR)/Select 
Agent Transfer and Entity Registration Information System (SATERIS), 
HHS/CDC/COTPER''. Records maintained in the National Select Agent 
Registry (NSAR)--a joint DSAT and U.S. Department of Agriculture/Animal 
and Plant Health Inspection Service (APHIS) information management 
system--are accessed by DSAT through the Select Agent Transfer and 
Entity Registration Information System (SATERIS) which is an user 
interface for data entry, data query, and routine reporting activities. 
The purpose of this system of records is to limit access to those 
select agents listed in 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 
331 to those individuals who have a legitimate need to handle or use 
such select agents, and who are not identified as a restricted person 
by the U.S. Attorney General. The NSAR is also used to track the 
possession, use, and transfer of select agents and is a single Web-
based system shared by DSAT and APHIS.
    DSAT conducts regulatory oversight of individuals and entities that 
possess, use, or transfer select agents. This includes the review of 
registration applications, conducting inspections of registered 
facilities or facilities requesting registration, processing requests 
to import select agents, processing all reports and requests received 
from individuals or entities regarding a select agent, and maintaining 
this information pertaining to individuals and entities that possess, 
use, and/or transfer select agents.
    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)

Coordinating Office for Terrorism Preparedness and Emergency Response 
(COTPER)

National Select Agent Registry (NSAR)/Select Agent Transfer and Entity 
Registration Information System (SATERIS)

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. 09-20-0170,'' National Select Agent Registry 
(NSAR)/Select Agent Transfer and Entity Registration Information System 
(SATERIS), HHS/CDC/COTPER''. 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

    Records maintained in the National Select Agent Registry (NSAR)--a 
joint DSAT and U.S. Department of Agriculture/Animal and Plant Health 
Inspection Service (APHIS) information management system--are accessed 
by DSAT through the Select Agent Transfer and Entity Registration 
Information System (SATERIS) which is an user interface for data entry, 
data query, and routine reporting activities. The purpose of this 
system of records is to limit access to those select agents listed in 
42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331 to those individuals 
who have a legitimate need to handle or use such select agents, and who 
are not identified

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as a restricted person by the U.S. Attorney General. The NSAR is also 
used to track the possession, use, and transfer of select agents and is 
a single Web-based system shared by DSAT and APHIS.
    DSAT conducts regulatory oversight of individuals and entities that 
possess, use, or transfer select agents. This includes the review of 
registration applications, conducting inspections of registered 
facilities or facilities requesting registration, processing requests 
to import select agents, processing all reports and requests received 
from individuals or entities regarding a select agent, and maintaining 
this information pertaining to individuals and entities that possess, 
use, and/or transfer select agents.

II. Authority for Maintenance of the System

    Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002 and the Agricultural Bioterrorism Protection Act of 2002 
(Pub. L. 107-188).

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 contractors to handle program work 
overflow duties, performing many of the same functions (listed in the 
Purpose section above) as DSAT employees. Contractors are required to 
maintain Privacy Act safeguards with respect to such records.
    Records may be disclosed to health departments and other public 
health or cooperating medical authorities to deal more effectively with 
outbreaks and conditions of public health significance.
    Personal information from this system may be disclosed as a routine 
use to assist the recipient Federal agency in making a determination 
concerning an individual's trustworthiness to access select agents; to 
any Federal or State agency where the purpose in making the disclosure 
is to prevent access to select agents for use in domestic or 
international terrorism or for any criminal purpose; or to any Federal 
or State agency to protect the public health and safety with regard to 
the possession, use, or transfer of select agents.
    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 Justice Department has agreed to represent such 
employee, 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 routine uses proposed for this System are compatible with the 
stated purpose of the System:
    An individual may learn if a record exists about himself or herself 
by contacting the system manager at the above address. Requesters in 
person must provide driver's license or other positive identification. 
Individuals who do not appear in person must submit a notarized request 
on institutional letterhead to verify their identity. 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 and/or imprisonment.
    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 by file folders, computer 
tapes and disks, CD-ROMs. The records are retrieved by name or DOJ 
identifier number.
    The following special safeguards are provided to protect the 
records from inadvertent disclosure:
    Authorized Users: A database security package is implemented on CDC 
computers to control unauthorized access to the system. Attempts to 
gain access by unauthorized individuals are automatically recorded and 
reviewed on a regular basis. Individuals who have routine access to 
these records are limited to Select Agent Program staff (DSAT FTEs and 
contractors) who have responsibility for conducting regulatory 
oversight of individuals and entities that possess, use, or transfer 
select agents.
    Physical Safeguards: Paper records are maintained in locked 
cabinets in locked rooms in a restricted access location that is 
controlled by a cardkey system, and security guard service provides 
personnel screening of visitors. Electronic data files are password 
protected and stored in a restricted access location. 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 location. Computer workstations, 
lockable personal computers, and automated records are located in 
secured areas.
    Procedural Safeguards: Protection for computerized records 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 the system is limited to users obtaining prior 
supervisory approval. To avoid inadvertent data disclosure, a special 
additional procedure is performed to ensure that all Privacy Act data 
are removed from computer tapes and/or other magnetic media. 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. Additional safeguards may also be built into the program by the 
system analyst

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as warranted by the sensitivity of the data set.
    The DSAT 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 CDC or contractor sites is restricted to 
specifically authorized personnel.
    Appropriate 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.
    The USDA/APHIS maintains similarly stringent safeguards that are 
discussed within that agency's Select Agent system of records notice.
    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 
COTPER 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 DSAT records and associated information are retained and 
dispositioned in accordance with DSAT records retention schedule, N1-
442-06-1, pending approval by the National Archives and Records 
Administration. The DSAT records will be retained for 10 years in 
compliance with the records retention schedule requirements or until 
such time as no longer needed for litigation or other records purposes. 
Records will be transferred to a Federal Records Center for storage 
when no longer in active use. Final disposition of records stored 
offsite at the Federal Records Center will be accomplished by a 
controlled process requesting final disposition approval from the 
record owner prior to any destruction to ensure records are not needed 
for litigation or other records purposes. Hard copy records and 
Sensitive But Unclassified (SBU) information designated for local 
disposition will be placed in a locked container or designated secure 
storage area while awaiting destruction. All SBU data will be destroyed 
in a manner that precludes its reconstruction, such as shredding.
    Electronic information will be deleted or overwritten using 
overwriting software that wipes the entire physical disk and not just 
the virtual disk. Overwriting is required for the destruction of all 
electronic SBU information.

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

    A. Full Title: ``National Select Agent Registry (NSAR)/Select Agent 
Transfer and Entity Registration Information System (SATERIS), HHS/CDC/
COTPER.''
    OMB Control Number: 09-20-0170.
    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. 2010-33028 Filed 1-24-11; 8:45 am]
BILLING CODE 4163-18-P