71702 Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Rules and Regulations 

FOR FURTHER INFORMATION CONTACT: J. 

Mark Reeves, Central Service Office, 

Airspace Branch, AGL–520, Federal 

Aviation Administration, 2300 East 

Devon Avenue, Des Plaines, IL 60018, 

telephone: (847) 294–7477.

SUPPLEMENTARY INFORMATION: 

History 

Federal Register Document 04–19370 

published on Tuesday, August 24, 2004 

(69 FR 51948), established Class E 

airspace at Northwood, ND. An 

incorrect coordinate was used in the 

legal description. This action corrects 

this error.

■ Accordingly, pursuant to the authority 

delegated to me, the error for the Class 

E airspace, Northwood, ND, as published 

in the Federal Register Tuesday, August 

24, 2004, (69 FR 51948), (FR Doc. 04–

19370), is corrected as follows:

PART 71—[AMENDED]

§ 71.1 [Corrected]

■ 1. On page 51948, Column 3; in the 

legal description, change the coordinates 

to read; (Lat. 47°43′27′′ N., long. 

97°35′26′′ W).

Issued in Des Plaines, Illinois on November 

16, 2004. 

Nancy B. Kort, 

Area Director, Central Terminal Operations.

[FR Doc. 04–27091 Filed 12–9–04; 8:45 am] 

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration 

14 CFR Part 71

[Docket No. FAA–2004–17096; Airspace 

Docket No. 04–AGL–05] 

Modification of Class E Airspace; 

South Haven, MI; Correction

AGENCY: Federal Aviation 

Administration (FAA), DOT.

ACTION: Final rule; correction.

SUMMARY: This action corrects errors 

contained in a final rule that was 

published in the Federal Register on 

Tuesday, August 24, 2004 (69 FR 

51946). The final rule modified Class E 

airspace at South Haven, MI.

EFFECTIVE DATE: 0901 UTC, November 

25, 2004.

FOR FURTHER INFORMATION CONTACT: J. 

Mark Reeves, Central Service Office, 

Airspace Branch, AGL–520, Federal 

Aviation Administration, 2300 East 

Devon Avenue, Des Plaines, IL 60018, 

telephone: (847) 294–7477.

SUPPLEMENTARY INFORMATION: 

History 

Federal Register document 04–19372 

published on Tuesday, August 24, 2004 

(69 FR 51946), modified Class E 

airspace at South Haven, MI. An 

incorrect coordinate was used in the 

legal description and it also contained 

an incorrect airspace exclusion. This 

action corrects these errors.

■ Accordingly, pursuant to the authority 

delegated to me, the errors for the Class 

E airspace, South Haven, MI, as 

published in the Federal Register

Tuesday, August 24, 2004, (69 FR 

51946), (FR Doc. 04–19372), is corrected 

as follows:

PART 71—[AMENDED]

§ 71.1 [Corrected]

■ 1. On page 51947, Column 1; in the 

legal description;

■ A. Change the coordinates for 

Watervliet, Watervliet Community 

Hospital, MI Point in Space to read; 

(Lat. 42°11′06′′ N., long. 86°15′02′′ W.)

■ B. Change ‘‘excluding that airspace 

within the South Bend, IN, Class E 

airspace area’’ to read; ‘‘excluding that 

airspace within the Benton Harbor, MI, 

Class E airspace area’’.

Issued in Des Plaines, Illinois on November 

16, 2004. 

Nancy B. Kort, 

Area Director, Central Terminal Operations.

[FR Doc. 04–27094 Filed 12–9–04; 8:45 am] 

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 2004N–0477]

Medical Devices; General Hospital and 

Personal Use Devices; Classification 

of Implantable Radiofrequency 

Transponder System for Patient 

Identification and Health Information

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

implantable radiofrequency transponder 

system for patient identification and 

health information into class II (special 

controls). The special control that will 

apply to the device is the guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: 

Implantable Radiofrequency 

Transponder System for Patient 

Identification and Health Information.’’

The agency is classifying the device into 

class II (special controls) in order to 

provide a reasonable assurance of safety 

and effectiveness of the device. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice of 

availability of a guidance document that 

is the special control for this device.

DATES: This rule is effective January 10, 

2005. The classification was effective 

October 12, 2004.

FOR FURTHER INFORMATION CONTACT: Gail 

Gantt, Center for Devices and 

Radiological Health (HFZ–480), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–1287.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 360c(f)(1)), 

devices that were not in commercial 

distribution before May 28, 1976, the 

date of enactment of the Medical Device 

Amendments of 1976 (the amendments), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the act, to a predicate device 

that does not require premarket 

approval. The agency determines 

whether new devices are substantially 

equivalent to previously marketed 

devices by means of premarket 

notification procedures in section 510(k) 

of the act (21 U.S.C. 360(k)) and 21 CFR 

part 807 of FDA’s regulations.

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request that 

FDA classify the device under the 

criteria set forth in section 513(a)(1) of 

the act. FDA shall, within 60 days of 

receiving such a request, classify the 

device by written order. This 

classification shall be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a document in the Federal 

Register announcing such classification 

(section 513(f)(2) of the act).

Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Rules and Regulations 71703

In accordance with section 513(f)(1) of 

the act, FDA issued a document on July 

22, 2004, classifying the VERICHIP 

Health Information Microtransponder 

System in class III, because it was not 

substantially equivalent to a device that 

was introduced or delivered for 

introduction into interstate commerce 

for commercial distribution before May 

28, 1976, or a device which was 

subsequently reclassified into class I or 

class II. On August 4, 2004, Digital 

Angel Corp. submitted a petition 

requesting classification of the 

VERICHIP Health Information 

Microtransponder System under section 

513(f)(2) of the act. The manufacturer 

recommended that the device be 

classified into class II (Ref. 1).

In accordance with section 513(f)(2) of 

the act, FDA reviewed the petition in 

order to classify the device under the 

criteria for classification set forth in 

section 513(a)(1) of the act. Devices are 

to be classified into class II if general 

controls, by themselves, are insufficient 

to provide reasonable assurance of 

safety and effectiveness, but there is 

sufficient information to establish 

special controls to provide reasonable 

assurance of the safety and effectiveness 

of the device for its intended use. After 

review of the information submitted in 

the petition, FDA determined that the 

VERICHIP Health Information 

Microtransponder System can be 

classified in class II with the 

establishment of special controls. FDA 

believes these special controls, in 

addition to general controls, will 

provide reasonable assurance of safety 

and effectiveness of the device.

The device is assigned the generic 

name implantable radiofrequency 

transponder system for patient 

identification and health information 

and is identified as a system intended 

to enable access to secure patient 

identification and corresponding health 

information. This system may include a 

passive implanted transponder, inserter, 

and scanner. The implanted 

transponder is used only to store a 

unique electronic identification code 

that is read by the scanner. The 

identification code is used to access 

patient identity and corresponding 

health information stored in a database.

The potential risks to health 

associated with the device are adverse 

tissue reaction, migration of implanted 

transponder, compromised information 

security, failure of implanted 

transponder, failure of inserter, failure 

of electronic scanner, electromagnetic 

interference, electrical hazards, 

magnetic resonance imaging 

incompatibility, and needle stick. The 

special controls document aids in 

mitigating the risks by identifying 

performance and safety testing, and 

appropriate labeling.

Therefore, in addition to the general 

controls of the act, an implantable 

radiofrequency transponder system for 

patient identification and health 

information is subject to special controls 

identified as the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Implantable 

Radiofrequency Transponder System for 

Patient Identification and Health 

Information.’’

FDA believes that following the class 

II special controls guidance document 

generally addresses the risks to health 

identified in the previous paragraph. 

Therefore, on October 12, 2004, FDA 

issued an order to the petitioner 

classifying the device into class II. FDA 

is codifying this classification by adding 

21 CFR 880.6300.

Section 510(m) of the act provides 

that FDA may exempt a class II device 

from the premarket notification 

requirements under section 510(k) of the 

act, if FDA determines that premarket 

notification is not necessary to provide 

reasonable assurance of the safety and 

effectiveness of the device. FDA has 

determined that premarket notification 

is not necessary to provide reasonable 

assurance of the safety and effectiveness 

of the implantable radiofrequency 

transponder system for patient 

identification and health information 

because the manufacturing controls, 

software validation science, and 

electrical safety standards in the special 

control guidance are well known. The 

measures needed to keep patient data 

secure are commonly in use. Thus, 

persons who intend to market this 

device type need not submit to FDA a 

premarket notification submission 

containing information on an 

implantable radiofrequency transponder 

system for patient identification and 

health information, unless they exceed 

the limitations on exemptions in 21 CFR 

880.9 (e.g., different intended use or 

fundamental scientific technology).

For the convenience of the reader, 

FDA is also adding new 21 CFR 880.1 

to inform readers of the availability of 

guidance documents referenced in 21 

CFR part 880.

II. Environmental Impact

The agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required.

III. Analysis of Impacts

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 104–4). 

Executive Order 12866 directs agencies 

to assess all costs and benefits of 

available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

agency believes that this final rule is not 

a significant regulatory action under the 

Executive order.

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because classification of these 

devices into class II will relieve 

manufacturers of the device of the cost 

of complying with the premarket 

approval requirements of section 515 of 

the act (21 U.S.C. 360e), and may permit 

small potential competitors to enter the 

marketplace by lowering their costs, the 

agency certifies that the final rule will 

not have a significant impact on a 

substantial number of small entities.

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $110 

million. FDA does not expect this final 

rule to result in any 1-year expenditure 

that would meet or exceed this amount.

IV. Federalism

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required.

71704 Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Rules and Regulations 

V. Paperwork Reduction Act of 1995

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required.

VI. Reference

The following reference has been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

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

through Friday.

1. Petition from Digital Angel Corp., dated 

August 4, 2004.

List of Subjects in 21 CFR Part 880

Medical devices.

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 880 is 

amended as follows:

PART 880—GENERAL HOSPITAL AND 

PERSONAL USE DEVICES

■ 1. The authority citation for 21 CFR 

part 880 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371.

■ 2. Section 880.1 is amended by adding 

new paragraph (e) to read as follows:

§ 880.1 Scope.

* * * * *

(e) Guidance documents referenced in 

this part are available on the Internet at 

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

■ 3. Section 880.6300 is added to subpart 

G to read as follows:

§ 880.6300 Implantable radiofrequency 

transponder system for patient 

identification and health information.

(a) Identification. An implantable 

radiofrequency transponder system for 

patient identification and health 

information is a device intended to 

enable access to secure patient 

identification and corresponding health 

information. This system may include a 

passive implanted transponder, inserter, 

and scanner. The implanted 

transponder is used only to store a 

unique electronic identification code 

that is read by the scanner. The 

identification code is used to access 

patient identity and corresponding 

health information stored in a database.

(b) Classification. Class II (special 

controls). The special control is FDA’s 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Implantable Radiofrequency 

Transponder System for Patient 

Identification and Health Information.’’

See § 880.1(e) for the availability of this 

guidance document. This device is 

exempt from the premarket notification 

procedures in subpart E of part 807 of 

this chapter subject to the limitations in 

§ 880.9.

Dated: November 30, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–27077 Filed 12–9–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117

[CGD01–04–106] 

RIN 1625–AA09

Drawbridge Operation Regulations: 

Connecticut River, CT

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is 

establishing a temporary final rule 

governing the operation of the Route 82 

Bridge, at mile 16.8, across the 

Connecticut River at East Haddam, 

Connecticut. This temporary final rule 

allows the bridge to operate on a fixed 

opening schedule and also authorizes 

several bridge closures from December 

1, 2004, through March 31, 2006. The 

purpose of this temporary final rule is 

to facilitate the rehabilitation 

construction at the Route 82 Bridge.

DATES: This temporary final rule is 

effective from December 1, 2004, 

through March 31, 2006.

ADDRESSES: Material received from the 

public, as well as documents indicated 

in this preamble as being available in 

the docket, are part of docket (CGD01–

04–106) and are available for inspection 

or copying at the First Coast Guard 

District, Bridge Branch Office, 408 

Atlantic Avenue, Boston, 

Massachusetts, 02110, 6:30 a.m. to 3 

p.m., Monday through Friday, except 

Federal holidays.

FOR FURTHER INFORMATION CONTACT: Ms. 

Judy Leung-Yee, Project Officer, First 

Coast Guard District, (212) 668–7195.

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

On October 19, 2004, we published a 

notice of proposed rulemaking (NPRM) 

entitled Drawbridge Operation 

Regulations; Connecticut River, 

Connecticut, in the Federal Register (69 

FR 61455). We received no comments in 

response to the notice of proposed 

rulemaking. No public hearing was 

requested and none was held. 

Under 5 U.S.C. 553(b)(B), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. 

The bridge rehabilitation construction 

has already been delayed over a year 

due to funding issues and as a result of 

those delays the rehabilitation repairs at 

the bridge need to be performed as soon 

as possible. 

Any delay encountered in this 

regulation’s effective date would be 

unnecessary and contrary to the public 

interest because the rehabilitation 

construction is necessary in order to 

assure continued safe reliable operation 

of the bridge. 

Background and Purpose 

The Route 82 Bridge has a vertical 

clearance of 22 feet at mean high water, 

and 25 feet at mean low water in the 

closed position. The existing 

drawbridge operating regulations listed 

at 33 CFR 117.205(c), require the bridge 

to open on signal at all times; except 

that, from May 15 to October 31, 9 a.m. 

to 9 p.m., the bridge is required to open 

for recreational vessels on the hour and 

half hour only. The bridge is required to 

open on signal at all times for 

commercial vessels. 

The Route 82 Bridge was scheduled 

for major repairs in the summer of 2001, 

and again in 2002, but due to a project 

funding shortfall the work was delayed. 

Subsequent to that, the bridge has 

continued to deteriorate. Funding has 

now been made available and the 

necessary repairs need to be performed 

with all due speed to assure safe reliable 

continued operation of the bridge. 

The bridge owner, Connecticut 

Department of Transportation, requested 

a temporary rule to allow the bridge to 

open at specific times. Commercial 

vessels may obtain bridge openings at 

any time provided they provide a twohour advance notice to the bridge 

tender. 

The bridge owner has also requested 

additional bridge closures that will 

restrict both recreational and 

commercial vessel traffic. The requested 

dates include: One seven day bridge 

closure from March 21, 2005 through 

March 28, 2005; three 8 hour closures 

on October 18, 19, and 20, 2005; and 

one 24 hour closure on December 14, 

2005. 

The exact dates and times for the 

above closures possibly may change due 

to unforeseen issues. Should the above