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 

Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Rules and Regulations 71705

dates and times change, the Coast Guard 

will revise this temporary rule and 

publish the exact times and dates in the 

Local Notice to Mariners at least thirtydays in advance of the anticipated 

occurrence of each closure to assist 

mariners in their planning. 

Under this final rule, in effect from 

December 1, 2004 through March 31, 

2006, the Route 82 Bridge will operate 

as follows: 

From November 1 through July 6, the 

draw will open on signal at 5:30 a.m., 

1:30 p.m., and 8 p.m., daily. 

From July 7 through October 31, the 

draw will open on signal Monday 

through Friday at 5:30 a.m., 1:30 p.m., 

and 8 p.m. On Friday the draw will 

open on signal at 5:30 a.m., 1:30 p.m., 

8 p.m., and 11:30 p.m. On Saturday and 

Sunday the draw will open at 5:30 a.m., 

8:30 a.m., 1:30 p.m., 4 p.m., 8 p.m., and 

11:30 p.m. 

At all times, other than during the 

closed periods identified above, the 

draw will open on signal for 

Commercial vessels provided at least a 

two-hour advance notice is given. 

Discussion of Comments and Changes

We received no comments in response 

to the notice of proposed rulemaking. 

No changes have been made to this 

temporary final rule as a result. 

Regulatory Evaluation 

This rule is not a ‘‘significant 

regulatory action’’ under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, and does not 

require an assessment of potential costs 

and benefits under section 6(a)(3), of 

that Order. The Office of Management 

and Budget has not reviewed it under 

that Order. It is not ‘‘significant’’ under 

the regulatory policies and procedures 

of the Department of Homeland Security 

(DHS). 

This conclusion is based on the fact 

vessel traffic will still be able to transit 

through the Route 82 Bridge under a 

fixed time schedule that is expected to 

meet the reasonable needs of navigation. 

Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601–612), we considered 

whether this rule would have a 

significant economic impact on a 

substantial number of small entities. 

The term ‘‘small entities’’ comprises 

small businesses, not-for-profit 

organizations that are independently 

owned and operated and are not 

dominant in their fields, and 

governmental jurisdictions with 

populations less than 50,000. 

The Coast Guard certifies under 5 

U.S.C. 605(b), that this rule will not 

have a significant economic impact on 

a substantial number of small entities. 

This conclusion is based on the fact 

that vessel traffic will still be able to 

transit through the Route 82 Bridge 

under a fixed time schedule that is 

expected to meet the reasonable needs 

of navigation. 

Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Public Law 104–

121), we offered to assist small entities 

in understanding the rule so that they 

could better evaluate its effects on them 

and participate in the rulemaking 

process. 

No small entities requested Coast 

Guard assistance and none was given. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1–

888–REG–FAIR (1–888–734–3247). 

Collection of Information 

This rule calls for no new collection 

of information under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). 

Federalism 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on State or local governments and 

would either preempt State law or 

impose a substantial direct cost of 

compliance on them. We have analyzed 

this rule under that Order and have 

determined that it does not have 

implications for federalism. 

Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 or more in any one year. 

Though this rule will not result in such 

an expenditure, we do discuss the 

effects of this rule elsewhere in this 

preamble. 

Taking of Private Property 

This rule will not effect a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 

Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

does not concern an environmental risk 

to health or risk to safety that may 

disproportionately affect children. 

Indian Tribal Governments 

This final rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Energy Effects 

We have analyzed this rule under 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

71706 Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Rules and Regulations 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This proposed rule does not use 

technical standards. Therefore, we did 

not consider the use of voluntary 

consensus standards.

Environment 

We have analyzed this final rule 

under Commandant Instruction 

M16475.1D, which guides the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded that there are no factors 

in this case that would limit the use of 

a categorical exclusion under section 

2.B.2 of the Instruction. Therefore, this 

rule is categorically excluded, under 

figure 2–1, paragraph (32)(e), of the 

Instruction, from further environmental 

documentation. It has been determined 

that this final rule does not significantly 

impact the environment.

List of Subjects in 33 CFR Part 117

Bridges.

Regulations

■ For the reasons set out in the preamble, 

the Coast Guard amends 33 CFR part 117 

as follows:

PART 117—DRAWBRIDGE 

OPERATION REGULATIONS

■ 1. The authority citation for part 117 

continues to read as follows:

Authority: 33 U.S.C. 499; Department of 

Homeland Security Delegation No. 0170.1; 33 

CFR 1.05–1(g); section 117.255 also issued 

under the authority of Pub. L. 102–587, 106 

Stat. 5039.

■ 2. From December 1, 2004 through 

March 31, 2006, § 117.205 is temporarily 

amended by suspending paragraph (c) 

and adding a new paragraph (d) to read 

as follows:

§ 117.205 Connecticut River.

* * * * *

(d) The draw of the Route 82 Bridge, 

mile 16.8, at East Haddam shall operate 

as follows: 

(1) From November 1 through July 6 

the draw shall open on signal at 5:30 

a.m., 1:30 p.m., and 8 p.m., daily. 

(2) From July 7 through October 31, 

Monday through Thursday, the draw 

shall open on signal at 5:30 a.m., 1:30 

p.m., and 8 p.m. On Friday the draw 

shall open on signal at 5:30 a.m., 1:30 

p.m., 8 p.m., and 11:30 p.m. On 

Saturday and Sunday the draw shall 

open on signal at 5:30 a.m., 8:30 a.m., 

1:30 p.m., 4 p.m., 8 p.m., and 11:30 p.m. 

(3) The draw need not open for the 

passage of vessel traffic on the following 

dates: March 21, 2005 through March 

28, 2005; October 18, 19 and 20, 2005; 

and December 14, 2005. 

(4) At all times, other than the dates 

identified in paragraph (d)(3) of this 

section, the draw shall open on signal 

for commercial vessels provided at least 

a two-hour advance notice is given.

Dated: November 29, 2004. 

David P. Pekoske, 

Rear Admiral, U.S. Coast Guard, Commander, 

First Coast Guard District.

[FR Doc. 04–27101 Filed 12–9–04; 8:45 am] 

BILLING CODE 4910–15–P

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117

[CGD08–04–018] 

RIN 1625–AA09

Drawbridge Operation Regulation; St. 

Croix River, Wisconsin, MN

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is changing 

the regulation governing the Prescott 

Highway Bridge, across the St. Croix 

River at Mile 0.3, at Prescott, Wisconsin. 

Under the rule, the drawbridge need not 

open for river traffic and may remain in 

the closed-to-navigation position from 

November 1, 2005, to April 1, 2006. 

This rule allows the bridge owners to 

make necessary repairs to the bridge.

DATES: This rule is effective November 

1, 2005, to April 1, 2006.

ADDRESSES: Comments and material 

received from the public, as well as 

documents indicated in this preamble as 

being available in the docket, are part of 

the docket [CGD08–04–018] and are 

available for inspection or copying at 

room 2.107f in the Robert A. Young 

Federal Building at Eighth Coast Guard 

District, between 8 a.m. and 4 p.m., 

Monday through Friday, except Federal 

holidays.

FOR FURTHER INFORMATION CONTACT: Mr. 

Roger K. Wiebusch, Bridge 

Administrator, (314) 539–3900, 

extension 2378.

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

On September 21, 2004, we published 

a notice of proposed rulemaking 

(NPRM) entitled Drawbridge Operation 

Regulation; St. Croix River, Wisconsin 

and Minnesota in the Federal Register

(69 FR 56379). We received no comment 

letters on the proposed rule. No public 

hearing was requested, and none was 

held. 

Background and Purpose 

On May 3, 2004, the Wisconsin 

Department of Transportation requested 

a temporary change to the operation of 

the Prescott Highway Bridge across the 

St. Croix River, Mile 0.3, at Prescott, 

Wisconsin, to allow the drawbridge to 

remain in the closed-to-navigation 

position for a 5-month period while the 

electrical and hydraulic systems are 

overhauled. Navigation on the waterway 

consists of both commercial (excursion 

boat) and recreational watercraft, which 

may be minimally impacted by the 

closure period. Currently, the draw 

opens on signal for passage of river 

traffic from April 1 to October 31, 8 a.m. 

to midnight, except that from midnight 

to 8 a.m. the draw shall open on signal 

if notification is made prior to 11 p.m. 

From November 1 to March 31, the draw 

shall open on signal if at least 24 hours 

notice is given. The Wisconsin 

Department of Transportation requested 

the drawbridge be permitted to remain 

closed to navigation from November 1, 

2005, to April 1, 2006. 

Discussion of Comments and Changes 

The Coast Guard received no 

comment letters. No changes will be 

made to this final rule. 

Regulatory Evaluation 

This rule is not a ‘‘significant 

regulatory action’’ under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, and does not 

require an assessment of potential costs 

and benefits under section 6(a)(3) of that 

Order. The Office of Management and 

Budget has not reviewed it under that 

Order. It is not ‘‘significant’’ under the 

regulatory policies and procedures of 

the Department of Homeland Security 

(DHS). 

The Coast Guard expects this 

temporary change to operation of the 

Prescott Highway Bridge to have 

minimal economic impact on 

commercial traffic operating on the St. 

Croix River such that a full regulatory 

evaluation under the regulatory policies 

and procedures of DHS is unnecessary. 

This temporary change will cause 

minimal interruption of the 

drawbridge’s regular operation, since 

the change is only in effect during the 

winter months while the river is frozen.