Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 67709 

Proximal Anastomotic Assist Devices 

Surgeons use proximal AADs in 

CABG procedures to avoid the need to 

clamp the aorta when attaching a 

harvested vessel to it. If a proximal AAD 

is not used, the surgeon must use a 

clamp to stop the flow of blood to a 

segment of the aorta while the harvested 

vessel is surgically attached. Using a 

clamp can cause calcified plaque 

particles to dislodge from the aorta and 

travel through the blood stream to the 

brain, risking neurological dysfunction 

or stroke. 

The proper geographic market in 

which to analyze the effects of the 

proposed transaction on the market for 

proximal AADs is the United States. 

Proximal AADs are medical devices that 

must be approved by the FDA before 

being marketed in the United States. As 

with other medical devices, the clinical 

testing and regulatory approval process 

for proximal AADs can be costly and 

time-consuming, preventing proximal 

AADs approved outside of the United 

States but not approved within the 

United States from serving as a 

competitive alternative for U.S. 

consumers. 

There are currently three firms in the 

U.S. market for proximal AADs, making 

it a highly concentrated market. The 

evidence indicates that J&J and 

Guidant’s manual proximal AADs are 

each others’ closest competitors. 

Medtronic also participates in the 

market with an automatic device that it 

recently launched in the United States. 

A fourth firm, St. Jude Medical, 

removed its automatic device, 

Symmetry, from the market last year 

amidst reports of device failures. J&J’s 

proximal AAD, eNclose, was 

developed and is manufactured by 

Novare; J&J and Novare have a 

distribution agreement making J&J the 

sole distributor of eNclose in the 

United States. 

As with the other medical devices 

discussed, entry into the market for 

proximal AADs is difficult, costly, and 

time-consuming. Additionally, the 

alleged safety concerns regarding St. 

Jude’s Symmetry device have resulted 

in greater scrutiny of proximal AADs by 

the FDA. The increased scrutiny is 

likely to substantially increase the cost 

of developing a proximal AAD. In 

addition, it appears that the publicity 

surrounding Symmetry’s removal from 

the market has dampened physician 

enthusiasm for these devices. These 

developments, along with the declining 

number of overall U.S. CABG 

procedures, decrease the likelihood of 

entry into this market. 

The proposed acquisition is likely to 

cause significant competitive harm in 

the market for proximal AADs by 

eliminating competition between J&J 

and Guidant and reducing the number 

of competitors in the market from three 

to two. The evidence has also shown 

that J&J and Guidant’s products are 

likely each others’ closest competitors 

in the proximal AAD market because 

they are more similar to each other than 

to Medtronic’s product. The proposed 

acquisition is therefore likely to enable 

the combined J&J/Guidant to raise prices 

for proximal AADs unilaterally. 

The proposed acquisition’s 

anticompetitive effects in the market for 

proximal AADs are remedied by the 

proposed Consent Agreement’s 

requirement that J&J terminate its 

distribution agreement with Novare for 

Novare’s proximal AAD, eNclose. It is 

anticipated that it will take Novare no 

more than two months to find a new 

distribution partner for eNclose. 

Appointment of an Interim Monitor and 

a Divestiture Trustee 

The proposed Consent Agreement 

contains a provision that allows the 

Commission to appoint an interim 

monitor to oversee J&J’s compliance 

with all of its obligations and 

performance of its responsibilities 

pursuant to the Commission’s Decision 

and Order. The interim monitor is 

required to file periodic reports with the 

Commission to ensure that the 

Commission remains informed about 

the status of the divestitures, about the 

efforts being made to accomplish the 

divestitures, and the provision of 

services and assistance during the 

transition period for the EVH 

divestiture. 

Finally, the proposed Consent 

Agreement contains provisions that 

allow the Commission to appoint a 

divestiture trustee if any or all of the 

above remedies are not accomplished 

within the time frames required by the 

Consent Agreement. The divestiture 

trustee may be appointed to accomplish 

any and all of the remedies required by 

the proposed Consent Agreement that 

have not yet been fulfilled upon 

expiration of the time period allotted for 

each. 

The purpose of this analysis is to 

facilitate public comment on the 

proposed Consent Agreement, and it is 

not intended to constitute an official 

interpretation of the proposed Decision 

and Order or to modify its terms in any 

way. 

By direction of the Commission, with 

Chairman Majoras and Commissioner 

Harbour recused. 

Donald S. Clark, 

Secretary. 

[FR Doc. 05–22165 Filed 11–7–05; 8:45 am] 

BILLING CODE 6750–01–P 

GOVERNMENT ACCOUNTABILITY 

OFFICE 

Advisory Council on Government 

Auditing Standards; Notice of Meeting 

The Advisory Council on Government 

Auditing Standards will meet Monday, 

December 5, 2005, from 8:30 a.m. to 5 

p.m., in room 7C13 of the Government 

Accountability Office building, 441 G 

Street, NW., Washington, DC. 

The Advisory Council on Government 

Auditing Standards will hold a meeting 

to discuss issues that may impact 

government auditing standards. The 

meeting is open to the public. Council 

discussions and reviews are open to the 

public. Members of the public will be 

provided an opportunity to address the 

Council with a brief (five minute) 

presentation on Monday afternoon. 

Any interested person who plans to 

attend the meeting as an observer must 

contact Sharon Chase, Council 

Assistant, 202–512–9406. A form of 

picture identification must be presented 

to the GAO Security Desk on the day of 

the meeting to obtain access to the GAO 

Building. For further information, 

please contact Ms. Chase. Please check 

the Government Auditing Standards 

Web page (http://www.gao.gov/govaud/ 

ybk01.htm) one week prior to the 

meeting for a final agenda. 

Jeanette M. Franzel, 

Director, Financial Management and 

Assurance. 

[FR Doc. 05–22205 Filed 11–7–05; 8:45 am] 

BILLING CODE 1610–02–P 

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). 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

we are proposing to establish a new 

67710 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 

SOR titled, ‘‘Medicare Prescription Drug 

Plan Finder (MPDPF) System, HHS/ 

CMS/CBC, System No. 09–70–0564.’’

Under the provisions of Section 101 of 

the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) (Pub. L. 108–173), CMS 

has provided the participants of 

eligibility transactions a query and 

response solution in a single data center 

using a three-tier architecture. 

Enterprise Business Services (EBS), the 

user interface, will have the 

responsibility of receiving identifying 

information on Medicare beneficiaries 

for processing eligibility requests and 

enrollment assistance with the Medicare 

Prescription Drug Benefit Program. 

These inbound messages will be sent to 

EBS for processing of the eligibility 

request and for securing the information 

from the CMS Community Based 

Organization/Customer Service 

Representative (CBO/CSR) Data Store, 

and for sending an available plan option 

response back via the internet. EBS will 

capture the identifying information and 

enrollment selection, and transmit it to 

the selected Medicare Prescription Drug 

Plan (PDP) or Medicare Advantage 

Prescription Drug Plan (MAPD). This 

initiative will streamline and facilitate 

drug benefit eligibility determination 

and the enrollment process. 

The primary purpose of this system is 

to provide a Web accessible inquiry 

system that will provide a mechanism to 

support an individual beneficiary’s 

efforts in performing drug benefit 

eligibility queries and to enroll them 

into selected plans. Information in this 

system will also be used to: (1) Support 

regulatory and policy functions 

performed within the Agency or by a 

contractor or consultant; (2) assist PDPs 

and MAPDs directly or through the 

Enterprise Business Services; (3) 

support constituent requests made to a 

Congressional representative; and (4) 

support litigation involving the Agency 

related to this system. We have 

provided background information about 

the proposed system in the 

‘‘Supplementary Information’’ section 

below. Although the Privacy Act 

requires only that the Aroutine use’’

portion of the system be published for 

comment, CMS invites comments on all 

portions of this notice. See EFFECTIVE 

DATES section for comment period. 

EFFECTIVE DATES: CMS filed a new 

system 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 November 1, 2005. To ensure 

that all parties have adequate time in 

which to comment, the new SOR, 

including routine uses, will become 

effective 40 days from the publication of 

the notice, or from the date it was 

submitted to OMB and the Congress, 

whichever is later, unless CMS receives 

comments that require alterations to this 

notice. 

ADDRESSES: The public should address 

comments to: CMS Privacy Officer, 

Division of Privacy Compliance Data 

Development, CMS, 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: 

Thomas Dudley, Division of Website 

Project Management, Beneficiary 

Information Services Group, Center for 

Beneficiary Choices, CMS, Mail Stop 

S1–01–26, 7500 Security Boulevard, 

Baltimore, Maryland, 21244–1850. His 

telephone number is 410–786–1442, or 

e-mail at Thomas.Dudley@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

public version of the toll will use 

knowledge based authentication (KBA), 

to provide the end user access to 

personalized information about their 

drug benefit eligibility and enrollment. 

KBA allows a user to access the system 

based on what they know without the 

need for a user id/password. To 

successfully authenticate, the user will 

need to provide the following 

information: Health Insurance Claim 

Number (HICN), Date of Birth, Last 

Name, Type of Enrollment, Effective 

date of enrollment, and Zip Code. This 

information will then be validated in 

the CMS Data Center. All data elements 

must match to successfully authenticate 

the user. If the authentication fails, the 

user will be taken directly to the default 

route and asked to respond to a series 

of questions in lieu of authentication. 

They will not be provided with ‘‘retry’’

options. If successfully authenticated, 

Part D and Part C information will be 

retrieved from the data center and 

passed to MPDPF. 

CMS has planned to provide the 

participants of eligibility transactions a 

query and response solution in a single 

data center using a three-tier 

architecture. EBS, the user interface, 

will have the responsibility of receiving 

identifying information on Medicare 

beneficiaries for processing eligibility 

requests and enrollment assistance with 

the Medicare Prescription Drug Benefit 

Program. These inbound messages will 

be sent to EBS for processing of the 

eligibility request and for securing the 

information from the CMS CBO/CSR 

Data Store, and for sending a response 

back via the internet. 

The drug benefit itself is very 

complex. The user must self-identify 

him/herself into one of 4 categories in 

order to get the options applicable in 

his/her circumstances (full dual subsidy 

eligible; full subsidy eligible; partial 

subsidy eligible; no subsidy eligible). 

CMS knows from prior education and 

consumer research efforts that it is 

extremely difficult for persons with 

Medicare to understand the nuances of 

these options and to accurately 

categorize them. This presents a 

challenge for both the direct beneficiary 

user and those assisting the beneficiary 

(CSRs and CBOs). However, CMS data 

systems contain information that can 

easily provide the user’s categorization 

and then enable the drug benefit tool to 

accurately present only those options 

that are applicable to his/her unique 

circumstances. This is the primary 

driver for the development of the 

eligibility query. 

A secondary, but also essential, driver 

is to provide an efficient means for users 

to explore their drug benefit choices. We 

need to ensure that we provide tools 

that can encourage the maximum 

number of Medicare beneficiaries to use 

self-service options given the volume of 

inquiries we are projecting and the 

extraordinary costs for servicing those 

calls. To meet the varying needs of 

different end-users, two different 

versions of the MPDPF will be 

developed: one tool will be used for the 

Public (including CBOs, and 

beneficiaries) and the other tool will be 

dedicated to CSR staffing the call 

centers that service 1–800–Medicare. 

I. Description of the Proposed System of 

Records 

A. Statutory and Regulatory Basis for 

the System 

Authority for this system is given 

under the provisions of Section 101 of 

the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) (Public Law 108–173). 

This new prescription drug benefit 

program was enacted into law on 

December 8, 2003, amended Title XVIII 

of the Social Security Act (the Act), and 

codified at Title 42 Code of Federal 

Regulations (CFR) Parts 403, 411, 417 

and 423 by establishing a new Medicare 

‘‘Part D’’ Prescription Drug Benefit 

program. Part D of Title XVIII of the Act, 

as amended by the MMA, and its 

implementing regulations at 42 CFR 

Parts 403, 411, 417 and 423. 

Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 67711 

B. Collection and Maintenance of Data 

in the System 

Information collected for this system 

will include but is not limited to, 

individuals who voluntarily access and 

who successfully validate information 

required by the Web-based Application 

Systems maintained by CMS. 

Information collected for this system 

will include, but is not limited to, last 

name, gender, HICN, telephone number, 

geographic location, type of enrollment 

(Medicare Part A or Part B), and 

effective date of enrollment in Part A 

and Part B. 

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 MPDPF 

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 MPDPF. CMS has the 

following policies and procedures 

concerning disclosures of information 

that will be maintained in the system. 

Disclosure of information from the 

system 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 

provide a Web accessible inquiry system 

that will provide a mechanism to 

support an individual beneficiary’s 

efforts in performing drug benefit 

eligibility queries and to enroll them 

into selected plans. 

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 

consultants who have been contracted 

by the Agency to assist in 

accomplishment of a CMS function 

relating to the purposes for this system 

and who need to have access to the 

records in order to assist CMS. 

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 functions relating 

to purposes for this system. 

CMS occasionally contracts out 

certain of its functions when this would 

contribute to effective and efficient 

operations. CMS must be able to give a 

contractor whatever information is 

necessary for the contractor to fulfill its 

duties. In these situations, safeguards 

are provided in the contract prohibiting 

the contractor from using or disclosing 

the information for any purpose other 

than that described in the contract and 

to return or destroy all information at 

the completion of the contract. 

2. To Medicare Prescription Drug 

Plans (PDP) and Medicare Advantage 

Prescription Drug Plans (MAPD) 

directly or through the Enterprise 

Business Services, a CMS intermediary 

for the administration of Title XVIII of 

the Act. 

PDPs and MAPDs require MPDPF 

information in order to establish the 

validity of evidence or to verify the 

accuracy of information presented by 

the individual, as it concerns the 

individual’s entitlement to Part D 

benefits under the Medicare 

Prescription Drug Benefit Program. 

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. 

Individuals sometimes request the 

help of a Member of Congress in 

resolving some 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. Whenever CMS is involved in 

litigation, or occasionally when another 

party is involved in litigation and CMS’s 

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. A determination would be 

made in each instance that, under the 

circumstances involved, the purposes 

served by the use of the information in 

the particular litigation is compatible 

with a purpose for which CMS collects 

the information. 

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, Subparts A and 

E, 65 FR 82462 (12–28–00)). 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 

67712 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 

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 EGovernment Act of 2002, the ClingerCohen 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 National 

Institute of Standards and Technology 

publications; HHS Information Systems 

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 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 

individual privacy as a result of the 

disclosure of information relating to 

individuals. 

Dated: October 27, 2005. 

Charlene Frizzera, 

Deputy Chief Operating Officer, Centers for 

Medicare & Medicaid Services. 

09–70–0564 

SYSTEM NAME: 

‘‘Medicare Prescription Drug Plan 

Finder (MPDPF) System, HHS/CMS/ 

CBC’’

SECURITY CLASSIFICATION: 

Level 3 Privacy Act Sensitive 

SYSTEM LOCATION: 

Centers for Medicare & Medicaid 

Services (CMS) Data Center, 7500 

Security Boulevard, North Building, 

First Floor, Baltimore, Maryland 21244–

1850, and at various contractor 

locations. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

Information collected for this system 

will include but is not limited to, 

individuals who voluntarily access and 

who successfully validate information 

required by the Web-based Application 

Systems maintained by CMS. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

Information collected for this system 

will include, but is not limited to, last 

name, gender, Health Insurance Claim 

Number (HICN), telephone number, 

geographic location, type of enrollment 

(Medicare Part A or Part B), and 

effective date of enrollment in Part A 

and Part B. 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

Authority for this system is given 

under the provisions of Section 101 of 

the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) (Public Law 108–173). 

This new prescription drug benefit 

program was enacted into law on 

December 8, 2003, amended Title XVIII 

of the Social Security Act (the Act), and 

codified at Title 42 Code of Federal 

Regulations (CFR) parts 403, 411, 417 

and 423 by establishing a new Medicare 

‘‘Part D’’ Prescription Drug Benefit 

program. Part D of Title XVIII of the Act, 

as amended by the MMA, and its 

implementing regulations at 42 CFR 

Parts 403, 411, 417 and 423. 

PURPOSE(S) OF THE SYSTEM: 

The primary purpose of this system is 

to provide a Web accessible inquiry 

system that will provide a mechanism to 

support an individual beneficiary’s 

efforts in performing drug benefit 

eligibility queries and to enroll them 

into selected plans. Information in this 

system will also be used to: (1) Support 

regulatory and policy functions 

performed within the Agency or by a 

contractor or consultant; (2) assist PDPs 

and MAPDs directly or through the 

Enterprise Business Services; (3) 

support constituent requests made to a 

Congressional representative; and (4) 

support litigation involving the Agency 

related to this system. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OR USERS AND

THE PURPOSES OF SUCH USES: 

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 

consultants who have been contracted 

by the Agency to assist in 

accomplishment of a CMS function 

relating to the purposes for this system 

and who need to have access to the 

records in order to assist CMS. 

2. To Medicare Prescription Drug 

Plans (PDP) and Medicare Advantage 

Prescription Drug Plans (MAPD) 

directly or through the Enterprise 

Business Services, a CMS intermediary 

for the administration of Title XVIII of 

the Act. 

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 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 

Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 67713 

records are both relevant and necessary 

to the litigation. 

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, Subparts A and 

E , 65 Fed. Reg. 82462 (12–28–00)). 

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). 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

Computer diskette and on magnetic 

storage media. 

RETRIEVABILITY: 

Information can be retrieved by the 

individual identifiable information of 

the beneficiary. 

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 EGovernment Act of 2002, the ClingerCohen 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 National 

Institute of Standards and Technology 

publications; HHS Information Systems 

Program Handbook and the CMS 

Information Security Handbook. 

RETENTION AND DISPOSAL: 

Records are maintained in a secure 

storage area with identifiers. Disposal 

occurs 6 years and 3 months from the 

time the individual accesses the 

MPDPF. 

SYSTEM MANAGER AND ADDRESS: 

Director, Beneficiary Information 

Services Group, Center for Beneficiary 

Choices, CMS, Mail Stop S1–01–26, 

7500 Security Boulevard, Baltimore, 

Maryland, 21244–1850. 

NOTIFICATION PROCEDURE: 

For purpose of access, the subject 

individual should write to the system 

manager who will require the system 

name, HICN, and for verification 

purposes, the subject individual’s name 

(woman’s maiden name, if applicable). 

RECORD ACCESS PROCEDURE: 

For purpose of access, use the same 

procedures outlined in Notification 

Procedures above. Requestors should 

also reasonably specify the record 

contents being sought. (These 

procedures are in accordance with 

Department regulation 45 CFR 5b.5 

(a)(2).) 

CONTESTING RECORD PROCEDURES: 

The subject individual should contact 

the system manager named above, and 

reasonably identify the record 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.) 

RECORD SOURCE CATEGORIES: 

Sources of information contained in 

this records system include data 

collected from the initial voluntary 

inquiry made by or on behalf of the 

individual and validated through the 

Medicare Beneficiary Database. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. 05–22192 Filed 11–7–05; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0226] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

013 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (FDA recognized 

consensus standards). This publication 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 013’’ (Recognition List 

Number: 013), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices. 

DATES: Submit written or electronic 

comments concerning this document at 

any time. See section VII of this 

document for the effective date of the 

recognition of standards announced in 

this document. 

ADDRESSES: Submit written requests for 

single copies on a 3.5’’ diskette of 

‘‘Modifications to the List of Recognized 

Standards, Recognition List Number: 

013’’ to the Division of Small 

Manufacturers, International and 

Consumer Assistance, Center for 

Devices and Radiological Health (HFZ–

220), Food and Drug Administration, 

1350 Piccard Dr., Rockville, MD 20850. 

Send two self-addressed adhesive labels 

to assist that office in processing your 

requests, or FAX your request to 301–

443–8818. Submit written comments 

concerning this document, or 

recommendations for additional 

standards for recognition, to the contact 

person (see FOR FURTHER INFORMATION

CONTACT). Submit electronic comments 

by e-mail: standards@cdrh.fda.gov. This 

document may also be accessed on 

FDA’s Internet site at http:// 

www.fda.gov/cdrh/fedregin.html. See 

section VI of this document for 

electronic access to the searchable