61738 Federal Register / Vol. 70, No. 206 / Wednesday, October 26, 2005 / Rules and Regulations 

mutation detection system they intend 

to market. 

II. What Is the Environmental Impact of 

This Rule? 

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. What Is the Economic Impact of 

This Rule? 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and 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 as defined 

by the Executive order and so it not 

subject to review 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 this 

device into class II will relieve 

manufacturers 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 economic 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 $115 

million using the most current (2003) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Does This Final Rule Have 

Federalism Implications? 

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. 

V. How Does This Rule Comply with 

the Paperwork Reduction Act of 1995? 

FDA concludes that this rule contains 

no collections of information. Therefore, 

clearance by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520) is not required. 

FDA also concludes that the special 

controls guidance document identified 

by this rule contains information 

collection provisions that are subject to 

review and clearance by OMB under the 

PRA. Elsewhere in this issue of the 

Federal Register, FDA is publishing a 

notice announcing the availability of the 

draft guidance entitled ‘‘Class II Special 

Controls Guidance Document: CFTR 

Gene Mutation Detection Systems.’’

VI. What References are on Display? 

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 Tm Bioscience Corp., 

dated April 4, 2005. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, 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 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for 21 CFR 

part 866 continues to read as follows: 

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

360j, 371. 

■ 2. Add § 866.5900 to subpart F to read 

as follows: 

§ 866.5900 Cystic fibrosis transmembrane 

conductance regulator (CFTR) gene 

mutation detection system. 

(a) Identification. The CFTR gene 

mutation detection system is a device 

used to simultaneously detect and 

identify a panel of mutations and 

variants in the CFTR gene. It is intended 

as an aid in confirmatory diagnostic 

testing of individuals with suspected 

cystic fibrosis (CF), carrier 

identification, and newborn screening. 

This device is not intended for standalone diagnostic purposes, prenatal 

diagnostic, pre-implantation, or 

population screening. 

(b) Classification. Class II (special 

controls). The special control is FDA’s 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

CFTR Gene Mutation Detection 

System.’’ See § 866.1(e) for the 

availability of this guidance document. 

Dated: October 17, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–21348 Filed 10–25–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[CGD05–05–124] 

RIN 1625–AA–09 

Drawbridge Operation Regulations; 

Knapps Narrows, MD 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, Fifth Coast 

Guard District, has approved a 

temporary deviation from the 

regulations governing the operation of 

the Route 33/Knapps Narrows Bridge, at 

mile 0.4, across Knapps Narrows, at 

Tilghman, Maryland. This deviation 

allows the drawbridge to remain closedto-navigation each day from 9 p.m. to 5 

a.m., beginning on Monday, October 24 

until Friday, October 28, 2005, to 

facilitate mechanical repairs. 

DATES: The deviation is effective from 9 

p.m. to 5 a.m. from October 24 until 

October 28, 2005. 

Federal Register / Vol. 70, No. 206 / Wednesday, October 26, 2005 / Rules and Regulations 61739 

ADDRESSES: Materials referred to in this 

document are available for inspection or 

copying at Commander (obr), Fifth Coast 

Guard District, Federal Building, 1st 

Floor, 431 Crawford Street, Portsmouth, 

VA 23704–5004 between 8 a.m. and 4 

p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is (757) 398–6422. Commander (obr), 

Fifth Coast Guard District maintains the 

public docket for this temporary 

deviation. 

FOR FURTHER INFORMATION CONTACT: Bill 

H. Brazier, Bridge Management 

Specialist, Fifth Coast Guard District, at 

(757) 398–6422. 

SUPPLEMENTARY INFORMATION: The Route 

33/Knapps Narrows Bridge, a basculetype drawbridge, has a vertical 

clearance in the closed position to 

vessels of 7 feet, at mean high water. 

Covington Machine and Welding, Inc. 

(CMW), is the contractor engaged to 

perform these repairs for the Maryland 

State Highway Administration (SHA), 

the bridge owner. CMW, on behalf of 

SHA, requested a temporary deviation 

from the operating regulations for the 

Route 33/Knapps Narrows Bridge, set 

out in 33 CFR 117.5, that requires to 

bridge to open promptly and fully for 

the passage of vessels when a request to 

open is given. 

CMW requested the temporary 

deviation to close the Route 33/Knapps 

Narrow Bridge to navigation to facilitate 

replacing leaking oil seals in the main 

drive gear reducer and the hydraulic 

braking system of the draw span. The 

lift span will be locked in the closed-tonavigation position each day from 9 

p.m. to 5 a.m. beginning on Monday, 

October 24, 2005 until and including 

Friday, October 28, 2005. At all other 

times, the bridge will operate in 

accordance with 33 CFR 117.5. 

The Coast Guard has informed the 

known users of the waterway of the 

closure periods for the bridge so that 

these vessels can arrange their transits 

to minimize any impact caused by the 

temporary deviation. 

In accordance with 33 CFR 117.35(c), 

this work will be performed with all due 

speed in order to return the bridge to 

normal operation as soon as possible. 

This deviation from the operating 

regulations is authorized under 33 CFR 

117.35. 

Dated: October 18, 2005. 

Waverly W. Gregory, Jr., 

Chief, Bridge Administration Branch, Fifth 

Coast Guard District. 

[FR Doc. 05–21322 Filed 10–25–05; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[COTP St. Petersburg 05–120] 

RIN 1625–AA00 

Safety Zone Regulation; Tampa Bay, 

FL 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the waters of Tampa Bay, Florida, in the 

vicinity of the Clearwater Memorial 

bascule bridge. This safety zone is being 

established to protect mariners from the 

hazards associated with the blasting 

demolition of the concrete portions of 

the Clearwater Memorial bascule bridge. 

This rule is necessary to provide for the 

safety of life on the navigable waters of 

the United States. 

DATES: This rule is effective from 9:30 

a.m. on October 4, 2005 through 2 p.m. 

on November 8, 2005. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket [COTP St. 

Petersburg 05–120] and are available for 

inspection or copying at Coast Guard 

Sector St. Petersburg, Prevention 

Department, 155 Columbia Drive, 

Tampa, Florida 33606–3598 between 

7:30 a.m. and 4 p.m., Monday through 

Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Lieutenant Junior Grade Jennifer 

Andrew at Coast Guard Sector St. 

Petersburg, Prevention Department, 

(813) 228–2191 Ext 8203. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

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

Coast Guard finds that good cause exists 

for not publishing an NPRM. The 

necessary details for the blasting 

demolition of the Clearwater Memorial 

bascule bridge were not provided with 

sufficient time remaining to publish an 

NPRM. Publishing a NPRM and 

delaying its effective date would be 

contrary to the public interest since 

immediate action is needed to minimize 

potential danger to the public during the 

blasting demolition of the Clearwater 

Memorial bascule bridge. The Coast 

Guard will issue a broadcast notice to 

mariners to advise mariners of the 

restriction along with Coast Guard 

assets on scene who will also provide 

notice of the safety zone to mariners. 

For the same reasons, under 5 U.S.C. 

553(d)(3), the Coast Guard finds that 

good cause exists for making this rule 

effective less than 30 days after 

publication in the Federal Register. 

Background and Purpose 

PCL construction was contracted to 

build a fixed bridge to replace the 

Clearwater Memorial Causeway Bridge 

and remove the existing bridge. The 

fixed bridge was completed early 

September and the removal of the 

bascule bridge was commenced on 

September 12, 2005. On September 13, 

2005 PCL contacted Coast Guard Sector 

St. Petersburg Prevention Department to 

discuss blasting the large concrete 

portions of the bascule bridge directly 

adjacent to the navigation channel along 

with the concrete counterweights for the 

metal bridge leafs. PCL will conduct two 

separate blasts on two different days to 

break up the concrete into smaller 

sections for removal. The first blast will 

be conducted tentatively on October 5, 

2005, at approximately 7:30 a.m. This 

first blast will fracture the main 

concrete vertical portions adjacent to 

the channel from the top to three feet 

above the waterline. The second blast 

will be conducted tentatively on 

October 26, 2005, at approximately 7:30 

a.m. This second and final blast will 

fracture the remaining three feet and the 

16 feet of bridge below the waterline. 

The use of explosives and the proximity 

of the concrete bridge structure to the 

navigable channel present a hazard to 

mariners transiting the area. This safety 

zone is being established to ensure the 

safety of life on the navigable waters of 

the United States. 

Discussion of Rule 

The safety zone will extend out from 

the Clearwater Memorial Causeway 

bascule Bridge in a 1,000 foot radius. 

Vessels and persons not under contract 

or employees of PCL are prohibited from 

entering, anchoring or transiting within 

this zone unless authorized by the 

Captain of the Port St. Petersburg or his 

designated representative. This safety 

zone is effective from 7:30 a.m. on 

October 4, 2005, through 2 p.m. on 

November 8, 2005. The Coast Guard 

does not know the exact dates that this 

safety zone will be enforced at this time. 

Coast Guard Sector St. Petersburg will 

give notice of the enforcement of the 

safety zone by issuing a Broadcast 

Notice to Mariners beginning 24 to 48 

hours before the blasting is scheduled to 

begin. On-scene notice will be provided 

by local Coast Guard and Pinellas