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 

58448 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices 

study involving a potential new patient 

population for an ICD with an approved 

functional indication. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized will 

represent the agency’s current thinking 

on functional indications for ICDs. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

To receive ‘‘Functional Indications for 

Implantable Cardioverter Defibrillators ‘‘

by fax, call the CDRH Facts-On-Demand 

system at 800–899–0381 or 301–827–

0111 from a touch-tone telephone. Press 

1 to enter the system. At the second 

voice prompt, press 1 to order a 

document. Enter the document number 

1304 followed by the pound sign (#). 

Follow the remaining voice prompts to 

complete your request. 

Persons interested in obtaining a copy 

of the draft guidance may also do so by 

using the Internet. CDRH maintains an 

entry on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). The 

collections of information addressed in 

the draft guidance document have been 

approved by OMB in accordance with 

the PRA under the regulations 

governing IDEs (21 CFR part 812, OMB 

control number 0910–0078) and PMAs 

(21 CFR part 814, OMB control number 

0910–0231). The labeling provisions 

addressed in the guidance have been 

approved by OMB under OMB control 

number 0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document on 

or before January 4, 2006. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: September 29, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20092 Filed 10–5–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

[DHS–2005–0066] 

Office of Inspector General; Privacy 

Act of 1974; Systems of Records 

AGENCY: Office of Investigations, Office 

of Inspector General, Department of 

Homeland Security. 

ACTION: Notice of revised Privacy Act 

systems of records. 

SUMMARY: In accordance with the 

Privacy Act of 1974, the Department of 

Homeland Security Office of Inspector 

General is giving notice of a revised and 

updated system of records titled, 

‘‘Investigations Data Management 

System (IDMS).’’

DATES: Comments must be received on 

or before November 7, 2005. 

ADDRESSES: You may submit comments, 

identified by Docket Number DHS–

2005–0066, by one of the following 

methods: 

EPA Federal Partner EDOCKET Web 

site: http://www.epa.gov/feddocket. 

Follow instructions for submitting 

comments on the Web site. DHS has 

joined the Environmental Protection 

Agency (EPA) online public docket and 

comment system on its Partner 

Electronic Docket System (Partner 

EDOCKET). 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Fax: (202) 254–4285 (This is not a 

toll-free number). 

Mail: Richard N. Reback, DHS, Office 

of Inspector General/STOP 2600, 245 

Murray Drive, SW., Building 410, 

Washington, DC 20528. 

Hand Delivery/Courier: Richard N. 

Reback, DHS, Office of Inspector 

General/STOP 2600, 245 Murray Drive, 

SW., Building 410, Washington, DC 

20528. 

Instructions: All submissions received 

must include the agency name and 

docket number for this notice. All 

comments received will be posted 

without change to http://www.epa.gov/ 

feddocket, including any personal 

information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.epa.gov/feddocket. You may also 

access the Federal eRulemaking Portal 

at http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Richard N. Reback, Department of 

Homeland Security, Office of Inspector 

General/STOP 2600, 245 Murray Drive, 

SW., Building 410, Washington, DC 

20528 by telephone (202) 254–4100 or 

facsimile (202) 254–4285; Nuala 

O’Connor Kelly, Chief Privacy Officer, 

Department of Homeland Security, 601 

S. 12th Street, Arlington, VA 22202–

4202 by telephone (571) 227–3813 or 

facsimile (571) 227–4171. 

SUPPLEMENTARY INFORMATION: 

The Privacy Act embodies fair 

information principles in a statutory 

framework governing the means by 

which the United States Government 

collects, maintains, uses and 

disseminates personally identifiable 

information. The Privacy Act applies to 

information that is maintained in a 

‘‘system of records.’’ A ‘‘system of 

records’’ is a group of any records under 

the control of an agency from which 

information is retrieved by the name of 

the individual or by some identifying 

number, symbol, or other identifying 

particular assigned to the individual. 

The Privacy Act requires each agency to 

publish in the Federal Register a 

description denoting the type and 

character of each system of records that 

the agency maintains, and the routine 

uses that are contained in each system 

in order to make agency record keeping 

practices transparent, to notify 

individuals regarding the uses to which 

personally identifiable information is 

put, and to assist the individual in 

finding such files within the agency. 

The Department of Homeland 

Security (DHS), Office of Inspector