[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Notices]
[Pages 38944-38948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13188]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of a New System of Records

AGENCY: Department of Health and Human Services (HHS), Centers for 
Medicare & Medicaid Services (CMS).

ACTION: Notice of a new System of Records (SOR).

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to establish a new system of records titled, 
``Health Insurance Portability and Accountability Act (HIPAA) 
Information Tracking System (HITS), System No. 09-70-0544.'' The Office 
of E-Health Standards and Services (OESS) has been delegated the 
responsibility to regulate and enforce compliance for violations of 
Transactions and Code Sets, Security, and Unique Identifier provisions 
of HIPAA. Enforcement of these provisions is a complaint driven 
process; seeking voluntary compliance from all HIPAA covered entities. 
OESS has procured the services of a contractor to provide a database 
for complaint intake and management, to manage and maintain the overall 
electronic complaint process. Due to investigatory activities, CMS is 
exempting this system from the notification, access, correction and 
amendment provisions of the Privacy Act of 1974.
    The purpose of this system is to store the results of all OESS 
regional investigations, to determine if there were violations as 
charged in the original complaint, to investigate complaints that 
appear to be in violation of the Transactions and Code Sets, Security, 
and Unique Identifier provisions of HIPAA, to refer violations to law 
enforcement activities as necessary, and to maintain and retrieve 
records of the results of the complaint investigations. Information 
retrieved from this SOR will also be disclosed to: (1) Support 
regulatory, reimbursement, and policy functions performed within the 
agency, HIPAA entities, or by a contractor or consultant; (2) assist 
another Federal or state agency in the enforcement of HIPAA regulations 
where sharing the information is necessary to complete the processing 
of a complaint, contribute to the accuracy of CMS's proper payment of 
Medicare benefits, and/or enable such agency to administer a Federal 
health benefits program; (3) support constituent requests made to a 
congressional representative; (4) support litigation involving the 
agency; and (5) combat fraud and abuse in certain health benefits 
programs. We have provided background information about the modified 
system in the ``Supplementary Information'' section below. Although the 
Privacy Act requires only that CMS provide an opportunity for 
interested persons to comment on the proposed routine uses, CMS invites 
comments on all portions of this notice. See ``Effective Dates'' 
section for comment period.

DATES: Effective Date: CMS filed a new SOR report with the Chair of the 
house Committee on Government Reform and Oversight, the Chair of the 
Senate Committee on Governmental Affairs, and the Administrator, Office 
of Information and Regulatory Affairs, Office of Management and Budget 
(OMB) on June 28, 2005. We will not disclose any information under a 
routine use until 30 days after publication. We may defer 
implementation of this SOR or one or more of the routine use statements 
listed below if we receive comments that persuade us to defer 
implementation.

ADDRESSES: The public should address comment to the CMS Privacy 
Officer, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850. Comments received will be available for review at 
this location, by appointment, during regular business hours, Monday 
through Friday from 9 a.m.-3 p.m., eastern daylight time.

FOR FURTHER INFORMATION CONTACT: Michael Phillips, Health Insurance 
Specialist, OESS, CMS, 7500 Security Boulevard, Mail Stop S2-24-15, 
Baltimore, Maryland 21244-1849, Telephone Number (410) 786-6713, 
[email protected].

SUPPLEMENTARY INFORMATION: HITS is used by OESS staff and consists of 
an electronic repository of information and documents and supplementary 
paper document files. The HITS system allows OESS to integrate all of 
OESS' various business process including all of its investigation 
activities to allow real time access and results reporting and other 
varied information management needs. HITS provides (1) a single, 
central, electronic repository of all OHS complaint documents and 
information including investigative files, correspondence, and 
administrative records; (2) easy, robust capability to search all of 
the information in OESS' repository; (3) better quality control at the 
front end with simplified data entry and stronger data validation; (4) 
tools to help staff work on and manage their casework; and (5) includes 
supplementary paper files. The system

[[Page 38945]]

has the capacity to generate reports concerning the status of current 
and closed complaints, reviews and correspondence.
    OESS investigative files maintained in HITS are either received as 
electronic documents or paper records that are compiled for law 
enforcement purposes. In the course of investigations, OESS often has a 
need to obtain confidential information involving individuals other 
than the complainant. In these cases, it is necessary for OHS to: (1) 
Preserve the confidentiality of this information, (2) avoid unwarranted 
invasions of personal privacy, and (3) assure recipients of Federal 
financial assistance that such information provided to OESS will be 
kept confidential. This assurance facilitates prompt and effective 
completion of the investigations.
    Unrestricted disclosure of confidential information in OESS files 
can impede ongoing investigations, invade personal privacy of 
individuals and organizations, reveal the identities of confidential 
sources, or otherwise impair the ability of OESS to conduct 
investigations. For these reasons, the CMS is exempting all 
investigative files from the notification, access, correction and 
amendment provisions under subsection (k)(2) of the Privacy Act.

I. Description of the Proposed System of Records

A. Statutory and Regulatory Basis for SOR

    Authority for maintenance of this system is given under provisions 
of the Health Insurance Portability and Accountability Act of 1996, 
Public Law (Pub. L. 104-191), published at 68 FR 60694 (October 23, 
2003). These regulations are codified at 45 Code of Federal Regulation, 
parts 160, 162, and 164.

B. Collection and Maintenance of Data in the System

    HITS will maintain a file of complaint allegations, information 
gathered during the complaint investigation, findings, and results of 
the investigation, and correspondence relating to the investigation. 
The collected information will contain name, address, telephone number, 
health insurance claim (HIC) number, geographic location, as well as, 
background information relating to Medicare or Medicaid issues of the 
complainant.

II. Agency Policies, Procedures, and Restrictions on the Routine Use

A. Agency Policies, Procedures, and Restrictions on the Routine Use

    The Privacy Act permits 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 disclosure of data is known as a ``routine use.'' 
The government will only release HITS information that can be 
associated with an individual as provided for under ``Section III. 
Proposed Routine Use Disclosures of Data in the System.'' Both 
identifiable and non-identifiable data may be disclosed under a routine 
use.
    We will only collect the minimum personal data necessary to achieve 
the purpose of HITS. CMS has the following policies and procedures 
concerning disclosures of information that will be maintained in the 
system. Disclosure of information from the SOR will be approved only to 
the extent necessary to accomplish the purpose of the disclosure and 
only after CMS:
    1. Determines that the use or disclosure is consistent with the 
reason that the data is being collected, e.g., to store the results of 
all OESS regional investigations, to determine if there were violations 
as charged in the original complaint, to investigate complaints that 
appear to be in violation of the HIPAA, to refer violations to law 
enforcement activities as necessary, and to maintain and retrieve 
records of the results of the complaint investigations.
    2. Determines that:
    a. The purpose for which the disclosure is to be made can only be 
accomplished if the record is provided in individually identifiable 
form;
    b. The purpose for which the disclosure is to be made is of 
sufficient importance to warrant the effect and/or risk on the privacy 
of the individual that additional exposure of the record might bring; 
and
    c. There is a strong probability that the proposed use of the data 
would in fact accomplish the stated purpose(s).
    3. Requires the information recipient to:
    a. Establish administrative, technical, and physical safeguards to 
prevent unauthorized use of disclosure of the record;
    b. Remove or destroy at the earliest time all patient-identifiable 
information; and
    c. Agree to not use or disclose the information for any purpose 
other than the stated purpose under which the information was 
disclosed.
    4. Determines that the data are valid and reliable.

III. Proposed Routine Use Disclosures of Data in the System

    A. 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 proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. We are proposing to establish the 
following routine use disclosures of information maintained in the 
system:
    1. To agency contractors or consultant who have been engaged by the 
agency to assist in the performance of a service related to this system 
of records and who need to have access to the records in order to 
perform the activity.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual or similar 
agreement with a third party to assist in accomplishing CMS function 
relating to purposes for this system or records.
    CMS occasionally contracts out certain of its functions when doing 
so would contribute to effective and efficient operations. CMS must be 
able to give a contractor or consultant whatever information is 
necessary for the contractor or consultant to fulfill its duties. In 
these situations, safeguards are provided in the contract prohibiting 
the contractor or consultant from using or disclosing the information 
for any purpose other than that described in the contract and requires 
the contractor or consultant to return or destroy all information at 
the completion of the contract.
    2. To another Federal or state agency to:
    a. Assist in the enforcement of HIPAA regulations for violations of 
Transactions and Code Sets, Security, and Unique Identifiers where 
sharing the information is necessary to complete the processing of a 
complaint,
    b. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits, and/or
    c. Enable such agency to administer a Federal health benefits 
program, or as necessary to enable such agency to fulfill a requirement 
of a Federal statute or regulation that implements a health benefits 
program funded in whole or in part with Federal funds.
    Other Federal or state agencies in their administration of a 
Federal health program may require HITS information in order to 
investigate complaint

[[Page 38946]]

allegations, evaluate information gathered during the complaint 
investigation, review findings and results of the investigation 
relating to the enforcement of HIPAA regulations for violations of 
Transactions and Code Sets, Security, and Unique Identifiers.
    3. To a member of Congress or to a congressional staff member in 
response to an inquiry of the congressional office made at the written 
request of the constituent about whom the record is maintained.
    Beneficiaries sometimes request the help of a member of Congress in 
resolving an issue relating to a matter before CMS. The member of 
Congress then writes CMS, and CMS must be able to give sufficient 
information to be responsive to the inquiry.
    4. To the Department of Justice (DOJ), court or adjudicatory body 
when:
    a. The agency or any component thereof, or
    b. Any employee of the agency in his or her official capacity, or
    c. Any employee of the agency in his or her individual capacity 
where the DOJ has agreed to represent the employee, or
    d. The United States Government is a party to litigation or has an 
interest in such litigation, and by careful review, CMS determines that 
the records are both relevant and necessary to the litigation and that 
the use of such records by the DOJ, court or adjudicatory body is 
compatible with the purpose for which the agency collected the records.
    Whenever CMS is involved in litigation, and occasionally when 
another party is involved in litigation and CMS' policies or operations 
could be affected by the outcome of the litigation, CMS would be able 
to disclose information to the DOJ, court or adjudicatory body 
involved.
    5. To a CMS contractor (including, but not necessarily limited to 
fiscal intermediaries and carriers) that assists in the administration 
of a CMS-administered health benefits program, or to a grantee of a 
CMS-administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud or abuse in such program.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual relationship or 
grant with a third party to assist in accomplishing CMS functions 
relating to the purpose of combating fraud and abuse.
    CMS occasionally contracts out certain of its functions and makes 
grants when doing so would contribute to effective and efficient 
operations. CMS must be able to give a contractor or grantee whatever 
information is necessary for the contractor or grantee to fulfill its 
duties. In these situations, safeguards are provided in the contract 
prohibiting the contractor or grantee from using or disclosing the 
information for any purpose other than that described in the contract 
and requiring the contractor or grantee to return or destroy all 
information.
    6. To another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any State or local governmental agency), that 
administers, or that has the authority to investigate potential fraud 
or abuse in, a health benefits program funded in whole or in part by 
Federal funds, when disclosure is deemed reasonably necessary by CMS to 
prevent, deter, discover, detect, investigate, examine, prosecute, sue 
with respect to, defend against, correct, remedy, or otherwise combat 
fraud or abuse in such programs.
    Other agencies may require HITS information for the purpose of 
combating fraud and abuse in such Federally funded programs.
    B. Additional Provisions Affecting Routine Use Disclosures. This 
system contains Protected Health Information (PHI) as defined by HHS 
regulation ``Standards for Privacy of Individually Identifiable Health 
Information'' (45 CFR Parts 160 and 164, 65 FR 82462 (12-28-00), 
Subparts A and E. Disclosures of PHI authorized by these routine uses 
may only be made if, and as, permitted or required by the ``Standards 
for Privacy of Individually Identifiable Health Information.''
    In addition, our policy will be to prohibit release even of not 
directly identifiable information, except pursuant to one of the 
routine uses or if required by law, if we determine there is a 
possibility that an individual can be identified through implicit 
deduction based on small cell sizes (instances where the patient 
population is so small that individuals who are familiar with the 
enrollees could, because of the small size, use this information to 
deduce the identity of the beneficiary).

IV. Safeguards

    CMS has safeguards in place for authorized users and monitors such 
users to ensure against excessive or unauthorized use. Personnel having 
access to the system have been trained in the Privacy Act and 
information security requirements. Employees who maintain records in 
this system are instructed not to release data until the intended 
recipient agrees to implement appropriate management, operational and 
technical safeguards sufficient to protect the confidentiality, 
integrity and availability of the information and information systems 
and to prevent unauthorized access.
    This system will conform to all applicable Federal laws and 
regulations and Federal, HHS, and CMS policies and standards as they 
relate to information security and data privacy. These laws and 
regulations include but are not limited to: the Privacy Act of 1974; 
the Federal Information Security Management Act of 2002; the Computer 
Fraud and Abuse Act of 1986; the Health Insurance Portability and 
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the 
corresponding implementing regulations. OMB Circular A-130, Management 
of Federal Resources, Appendix III, Security of Federal Automated 
Information Resources also applies. Federal, HHS, and CMS policies and 
standards include but are not limited to: All pertinent NIST 
publications; the DHHS Information Security Program Handbook and the 
CMS Information Security Handbook.

V. Effects of the Proposed System of Records on Individual Rights

    CMS proposes to establish this system in accordance with the 
principles and requirements of the Privacy Act and will collect, use, 
and disseminate information only as prescribed therein. Data in this 
system will be subject to the authorized releases in accordance with 
the routine uses identified in this system of records.
    CMS will take precautionary measures (see item IV above) to 
minimize the risks of unauthorized access to the records and the 
potential harm to individual privacy or other personal or property 
rights of patients whose data are maintained in the system. CMS will 
collect only that information necessary to perform the system's 
functions. In addition, CMS will make disclosure from the proposed 
system only with consent of the subject individual, or his/her legal 
representative, or in accordance with an applicable exception provision 
of the Privacy Act. CMS, therefore, does not anticipate an unfavorable 
effect on

[[Page 38947]]

individual privacy as a result of information relating to individuals.

John R. Dyer,
Chief Operating Officer.
SYSTEM NO. 09-70-0544

SYSTEM NAME:
    ``Health Insurance Portability and Accountability Act (HIPAA) 
Information Tracking System (HITS), HHS/CMS/OESS''.

Security Classiffication:
    Level Three Privacy Act Sensitive Data.

SYSTEM LOCATION:
    Atlantic Telephone & Telegraph Company, Ashburn, Virginia facility 
under the control of the Center for Medicare & Medicaid Services.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Individuals who have filed complaints alleging violations of the 
Transactions and Code Sets, Security, and Unique Identifier provisions 
under the Health Insurance Portability and Accountability Act of 1996, 
Public Law 104-191, 68 FR 60694 (October 23, 2003). These regulations 
are codified at 45 CFR, parts 160, 162 and 164.

CATEGORIES OF RECORDS IN THE SYSTEM:
    HITS will maintain a file of complaint allegations, information 
gathered during the complaint investigation, findings, and results of 
the investigation, and correspondence relating to the investigation. 
The collected information will contain name, address, telephone number, 
health insurance claim (HIC) number, geographic location, as well as, 
background information relating to Medicare or Medicaid issues.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Authority for maintenance of this system is given under provisions 
of the Health Insurance Portability and Accountability Act of 1996, 
(Pub. L. 104-191), published at 68 FR 60694 (October 23, 2003). These 
regulations are codified at 45 Code of Federal Regulation, parts 160, 
162, and 164.

PURPOSE(S) OF THE SYSTEM:
    The purpose of this system is to store the results of all OESS 
regional investigations, to determine if there were violations as 
charged in the original complaint, to investigate complaints that 
appear to be in violation of the Transactions and Code Sets, Security, 
and Unique Identifier provisions of HIPAA, to refer violations to law 
enforcement activities as necessary, and to maintain and retrieve 
records of the results of the complaint investigations. Information 
retrieved from this SOR will also be disclosed to: (1) Support 
regulatory, reimbursement, and policy functions performed within the 
agency, HIPAA entities, or by a contractor or consultant; (2) assist 
another Federal or state agency in the enforcement of HIPAA regulations 
where sharing the information is necessary to complete the processing 
of a complaint, contribute to the accuracy of CMS's proper payment of 
Medicare benefits, and/or enable such agency to administer a Federal 
health benefits program; (3) support constituent requests made to a 
congressional representative; (4) support litigation involving the 
agency; and (5) combat fraud and abuse in certain health benefits 
programs.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OR USERS AND THE PURPOSES OF SUCH USES:
    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.'' We are proposing to establish the following routine use 
disclosures of information maintained in the system. Information will 
be disclosed:
    1. To agency contractors or consultants who have been engaged by 
the agency to assist in the performance of a service related to this 
system of records and who need to have access to the records in order 
to perform the activity.
    2. To another Federal or state agency to:
    a. Assist in the enforcement of HIPAA regulations for violations of 
Transactions and Code Sets, Security, and Unique Identifiers where 
sharing the information is necessary to complete the processing of a 
complaint,
    b. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits, and/or
    c. Enable such agency to administer a Federal health benefits 
program, or as necessary to enable such agency to fulfill a requirement 
of a Federal statute or regulation that implements a health benefits 
program funded in whole or in part with Federal funds.
    3. To a member of congress or to a congressional staff member in 
response to an inquiry of the congressional office made at the written 
request of the constituent about whom the record is maintained.
    4. To the Department of Justice (DOJ), court or adjudicatory body 
when:
    a. The agency or any component thereof, or
    b.Any employee of the agency in hisor h4r official capacity, or
    c. Any employee of the agency in his or her individual capacity 
where the DOJ has agreed to The United States Government is a party to 
litigation or has an interest in such litigation, and by careful 
review, CMS determines that the records are both relevant and necessary 
to the litigation and that the use of such records by the DOJ, court or 
adjudicatory body is compatible with the purpose for which the agency 
collected the records.
    5. To a CMS contractor (including, but not necessarily limited to 
fiscal intermediaries and carriers) that assists in the administration 
of a CMS-administered health benefits program, or to a grantee of a 
CMS-administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud or abuse in such program.
    6. To another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any State or local governmental agency), that 
administers, or that has the authority to investigate potential fraud 
or abuse in, a health benefits program funded in whole or in part by 
Federal funds, when disclosure is deemed reasonably necessary by CMS to 
prevent, deter, discover, detect, investigate, examine, prosecute, sue 
with respect to, defend against, correct, remedy, or otherwise combat 
fraud or abuse in such programs.
    B. Additional Provisions Affecting Routine Use Disclosures This 
system contains Protected Health Information as defines by HHS 
regulation ``Standards for Privacy of Individually Identifiable Health 
Information'' (45 CFR Parts 160 and 164, 65 FR 82462 (12-28-00), 
Subparts A and E). Disclosures of Protected Health Information 
authorized by these routine uses may only be made if, and as, permitted 
or required by the ``Standards for Privacy of Individually Identifiable 
Health Information.''
    In addition, our policy will be to prohibit release even of not 
directly identifiable information, except pursuant to one of the 
routine uses or if required by law, if we determine there is a 
possibility that an individual can be identified through implicit 
deduction based on small cell sizes (instances where the complaint 
population is so small that individuals who are familiar with the 
complainants could, because of

[[Page 38948]]

the small size, use this information to deduce the identity of the 
complainant).

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    All records are stored electronically.

RETRIEVABILITY:
    The complaint data are retrieved by an individual identifier i.e., 
name of complainant.

SAFEGUARDS:
    CMS has safeguards in place for authorized users and monitors such 
users to ensure against excessive or unauthorized use. Personnel having 
access to the system have been trained in the Privacy Act and 
information security requirements. Employees who maintain records in 
this system are instructed not to release data until the intended 
recipient agrees to implements appropriate management, operational and 
technical safeguards sufficient to protect the confidentiality, 
integrity and availability of the information and information systems 
and to prevent unauthorized access.
    This system will conform to all applicable Federal laws and 
regulations and Federal, HHS, and CMS policies and standards as they 
relate to information security and data privacy. These laws and 
regulations include but are not limited to: The Privacy Act of 1974; 
the Federal Information Security Management Act of 2002; the Computer 
Fraud and Abuse Act of 1986; the Health Insurance Portability and 
Accountability Act of 1996; the E-Government Act of 2002; the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the 
corresponding implementing regulations. OMB Circular A-130, Management 
of Federal Resources, Appendix III, Security of Federal Automated 
Information Resources also applies. Federal, HHS, and CMS policies and 
standards include but are not limited to: All pertinent NIST 
publications; the DHHS Information Security Program Handbook and the 
CMS Information Security Handbook.

RETENTION AND DISPOSAL:
    CMS will retain complaint information for a total period not to 
exceed 25 years.

SYSTEM MANAGER AND ADDRESS:
    Director, Office of E-Health Standards and Services, CMS, Room S2-
26-17, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

NOTIFICATION PROCEDURE:
    Exempt. However, portions of this system notice are non-exempt and 
consideration will be given to requests addressed to the system manager 
for those portions. For general inquiries, it would be helpful if the 
request included the system name, address, age, sex, and for 
verification purposes, the subject individual's name (woman's maiden 
name, if applicable) and complaint tracking ID number.

RECORD ACCESS PROCEDURE:
    Same as notification procedures. Requestors should also specify the 
record contents being sought.

CONTESTING RECORDS PROCEDURES:
    The subject individual should contact the system manager named 
above and reasonably identify the records and specify the information 
to be contested. State the corrective action sought and the reasons for 
the correction with supporting justification. (These Procedures are in 
accordance with Department regulation 45 CFR 5b.7).

RECORDS SOURCE CATEGORIES:
    OESS investigative files maintained in HITS are either received as 
electronic documents or paper records that are compiled for law 
enforcement purposes. In the course of investigations, OESS often has a 
need to obtain confidential information involving individuals other 
than the complainant.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    HHS claims exemption of certain records (case files on active fraud 
investigations) in the system from notification and access procedures 
under 5 U.S.C. 552a(k)(2) inasmuch as these records are investigatory 
materials compiled for program (law) enforcement in anticipation of a 
criminal or administrative proceedings. (See Department Regulation (45 
CFR 5b.11)).

[FR Doc. 05-13188 Filed 7-5-05; 8:45 am]
BILLING CODE 4120-03-P