58446 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

All records are stored on magnetic 

media. 

RETRIEVABILITY: 

Information collected will be 

retrieved by the name or other 

identifying information of the 

participating provider, and may also be 

retrievable by HICN at the individual 

beneficiary record level. 

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 ClingerCohen Act of 1996; the Medicare 

Modernization Act of 2003, and the 

corresponding implementing 

regulations. Office of Management and 

Budget 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; 

the HHS Information Systems Program 

Handbook and the CMS Information 

Security Handbook. 

RETENTION AND DISPOSAL: 

CMS will retain identifiable 

information maintained in the MCMP 

system of records for a period of 6 years. 

Data residing with the designated claims 

payment contractor shall be returned to 

CMS at the end of the project, with all 

data then being the responsibility of 

CMS for adequate storage and security. 

All claims-related records are 

encompassed by the document 

preservation order and will be retained 

until notification is received from the 

DOJ. 

SYSTEM MANAGER AND ADDRESS: 

Director, Medicare Demonstration 

Program Group, Office of Research 

Development and Information, CMS, 

7500 Security Boulevard, Mail stop C4–

17–27, 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, and for verification purposes, the 

subject individual’s name, provider 

identification number, and the patient’s 

medical record number. 

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: 

Information maintained in this system 

will be collected from physicians 

volunteering to participate in the MCMP 

Demonstration. Additional data will be 

collected from Medicare claims 

payment records. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. 05–19907 Filed 10–5–05; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

The Essentials of Food and Drug 

Administration Device Regulations: A 

Primer for Manufacturers and 

Suppliers; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Philadelphia 

District, in cooperation with AdvaMed’s 

Medical Technology Learning Institute, 

is announcing a public workshop on 

FDA device regulations. This 1 1/2-day 

public workshop for start up and small 

device manufacturers and their 

suppliers will include both industry and 

FDA perspectives and a question and 

answer period. 

Date and Time: The public workshop 

will be held on Tuesday, October 11, 

2005, from 8:30 a.m. to 5:30 p.m. and 

Wednesday, October 12, 2005, from 8:30 

a.m. to 12 noon. 

Location: The public workshop will 

be held at The Wyndham Philadelphia 

at Franklin Plaza, 17th and Race St., 

Philadelphia, PA 19103, 215–448–2000. 

For further hotel information and 

driving directions, go to http:// 

www.wyndham.com/hotels/PHLFP. 

(FDA has verified the Web site address, 

but is not responsible for subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.) 

Contact: 

For FDA: Judy Summers-Gates, Food 

and Drug Administration, rm. 900, 

U.S. Customhouse, 200 Chestnut 

St., Philadelphia, PA 19106, 215–

717–3008, FAX: 215–597–4660, email: judith.summersgates@fda.gov. 

For AdvaMed: Krystine McGrath, 

202–434–7237, FAX: 202–783–

8750, kmcgrath@advamed.org; or 

Dia Black, 202–434–7231, FAX: 

202–783–8750, e-mail: 

dblack@avamed.org. 

Registration: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), and the registration fee of $350 

per person to the AdvaMed contacts (see 

Contact). The registration fee for FDA 

employees is waived. To register via the 

Internet go to http://www.advamed.org/ 

philadelphia. (FDA has verified the Web 

site address, but is not responsible for 

subsequent changes to the Web site after 

this document publishes in the Federal 

Register.) 

Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices 58447 

Payment forms accepted are major 

credit card (MasterCard, Visa, or 

American Express) or company check. If 

you wish to pay by check contact 

Krystine McGrath (see Contact). For 

more information on the meeting, or for 

questions on registration, contact 

Krystine McGrath or Dia Black (see 

Contact). Attendees are responsible for 

their own accommodations. 

The registration fee will be used to 

offset the expenses of hosting the 

workshop, including meals (breakfasts 

and a lunch), refreshments, meeting 

rooms, and training materials. It also 

includes a networking reception on 

Tuesday, October 11, 2005. Space is 

limited, therefore interested parties are 

encouraged to register early. There will 

be no onsite registration. 

If you need special accommodations 

due to a disability, please contact Judy 

Summers-Gates at least 7 days in 

advance of the workshop. 

SUPPLEMENTARY INFORMATION: The 

‘‘Essentials of FDA Device Regulations: 

A Primer for Manufacturers and 

Suppliers’’ workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health by educating 

new entrepreneurs on the essentials of 

FDA device regulations. FDA has made 

education of the medical device 

community a high priority to assure the 

quality of products reaching the 

marketplace and to increase the rate of 

voluntary industry compliance with 

regulations. 

The workshop helps to implement the 

objectives of section 903 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

393) and the FDA Plan for Statutory 

Compliance, which includes working 

more closely with stakeholders and 

ensuring access to needed scientific and 

technical expertise. The workshop also 

furthers the goals of the Small Business 

Regulatory Enforcement Fairness Act 

(Public Law 104–121) by providing 

outreach activities by government 

agencies directed to small businesses. 

The following topics will be 

discussed at the workshop: 

• Doing business in a regulated 

industry; 

• Organizational structure of FDA; 

• The quality system regulations and 

inspections; 

• Complaints, medical device 

reporting, corrections, and recalls; 

• Compliance issues; 

• Management responsibility; 

• Interacting with FDA—where do 

you go for assistance?; 

• General question and answer 

session; 

• Manufacturers and suppliers—the 

chain of regulatory responsibility; 

• Reimbursement and medical 

rechnology; 

• The AdvaMed code of ethics; and 

• Fraud and abuse. 

Dated: September 30, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20093 Filed 10–5–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0391] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Functional Indications for Implantable 

Cardioverter Defibrillators; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Functional Indications for 

Implantable Cardioverter Defibrillators.’’

Many implantable cardioverter 

defibrillators (ICDs) currently have a 

functional indication. This draft 

guidance is designed to describe ICD 

functional indications and the types of 

devices appropriate for the indication; 

to provide guidance regarding labeling, 

advertising, and promotion of ICDs with 

an approved functional indication and 

cardiac resynchronization therapy 

defibrillators (CRT/ICDs) with an 

approved indication that describes the 

function of the ICD component; and to 

discuss when to submit an application 

for an investigational device exemption 

(IDE) for a study involving a potential 

new patient population for an ICD with 

an approved functional indication. 

DATES: Submit written or electronic 

comments on this draft guidance by 

January 4, 2006. 

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled 

‘‘Functional Indications for Implantable 

Cardioverter Defibrillators’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–443–8818. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit written comments concerning 

this draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

For premarket issues: Owen Faris or 

Megan Moynahan, Center for 

Devices and Radiological Health 

(HFZ–450), Food and Drug 

Administration, 9200 Corporate 

Blvd., Rockville, MD 20850, 301–

443–8517. 

For promotion and advertising issues: 

Deborah Wolf, Center for Devices 

and Radiological Health (HFZ–302), 

Food and Drug Administration, 

2094 Gaither Rd., Rockville, MD 

20850, 301–594–4589. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Prior to June 2000, the indication 

statement for ICDs included language to 

describe the types of patients who 

would benefit from an ICD. If a 

manufacturer demonstrated in a clinical 

trial that a new patient population 

benefited from its ICD, that 

manufacturer could submit a premarket 

approval application (PMA) supplement 

to update its indication statement to 

include that new patient population. 

That manufacturer could then promote 

its ICD as indicated for the new 

population. On June 20, 2000, FDA held 

a public meeting of the Circulatory 

Systems Devices Panel to introduce the 

concept of a functional indication. The 

functional indication describes what the 

device does and does not explicitly 

specify as an indicated patient 

population or expected outcome. FDA 

presented the functional indication as a 

least burdensome method of allowing 

the clinical community to identify the 

patient populations that would benefit 

from an ICD. The panel endorsed the 

functional indication concept for ICDs 

and, since that time, FDA has approved 

a functional indication for most 

manufacturers’ ICDs. This guidance 

document is intended to discuss the 

intended patient population for ICDs 

with an approved functional indication 

and CRT/ICDs with an approved 

indication that describes the function of 

the ICD component, labeling, 

advertising, and promotion of those 

ICDs and CRT/ICDs, and when to 

submit an application for an IDE for a