61736 Federal Register / Vol. 70, No. 206 / Wednesday, October 26, 2005 / Rules and Regulations 

Robert Parker Hospital Heliport. The 

affected Class E–5 airspace for the 

airports included in these descriptions 

will be consolidated into the amended 

Binghamton, NY airspace description 

contained in Docket No. FAA–2005–

22100, Airspace Docket No. 05–AEA–

16, effective February 16, 2006. 

DATES: Effective date: February 16, 2006. 

Comment Date: Comments must be 

received on or before November 25, 

2005. 

ADDRESSES: Send comments on the rule 

to the Docket Management System, U.S. 

Department of Transportation, Room 

Plaza 401, 400 Seventh Street, SW., 

Washington, DC 20590–0001. You must 

identify the docket number FAA–2005–

22494; Airspace Docket No. 05–AEA–22 

at the beginning of your comments. You 

may also submit comments on the 

Internet at http://dms.dot.gov. You may 

review the public docket containing the 

rule, any comments received, and any 

final disposition in person in the Docket 

Office between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. The Docket Office (telephone 

1–800–647–5527) is on the plaza level 

of the Department of Transportation 

NASSIF Building at the above address. 

An informal docket may also be 

examined during normal business hours 

at the office of the Area Director, Eastern 

Terminal Operations, Federal Aviation 

Administration, 1 Aviation Plaza, 

Jamaica, NY 11434–4890. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Francis T. Jordan, Jr., Airspace 

Specialist, Airspace and Operations, 

ETSU, Federal Aviation Administration, 

1 Aviation Plaza, Jamaica, NY 11434–

4809, telephone: (718) 553–4521. 

SUPPLEMENTARY INFORMATION: 

Although this action is a final rule, 

which involves the amendment of Class 

E airspace surrounding Binghamton, 

NY, by consolidating that airspace into 

one description, and was not preceded 

by notice and public procedure, 

comments are invited on the rule. This 

rule will become effective on the date 

specified in the DATES section. However, 

after the review of any comments, if the 

FAA finds that further changes are 

appropriate, it will initiate rulemaking 

proceedings to extend the effective date 

or to amend the regulation. 

Comments that provide the factual 

basis supporting the views and 

suggestions presented are particularly 

helpful in evaluating the effects of the 

rule, and in determining whether 

additional rulemaking is required. 

Comments are specifically invited on 

the overall regulatory, aeronautical, 

economic, environmental, and energyrelated aspects of the rule which might 

suggest the need to modify the rule. 

The Rule 

This amendment to Part 71 of the 

Federal Aviation Regulations (14 CFR 

Part 71) amends the description of Class 

E airspace in the Binghamton, NY area 

by removing the airspace designations 

for Cortland, NY, Cortland CountyChase Field Airport (N03); Ithaca, NY, 

Tompkins County Airport (ITH); Elmira, 

NY, Elmira/Corning Regional Airport 

(ELM); Endicott, NY, Tri-Cities Airport 

(CZG); and Sayre, PA, Robert Parker 

Hospital Heliport. It consolidates those 

airspace areas into the amended 

Binghamton, NY description. The 

proliferation of airports with Instrument 

Flight Rule (IFR) operations within the 

Binghamton, NY geographic area has 

resulted in the overlap of numerous 

Class E airspace areas that complicate 

the chart depictions. 

This action clarifies the airspace and 

diminishes the scope and complexity of 

charting. The IFR airports within those 

areas will be incorporated into the 

Binghamton, NY Class E airspace area. 

Accordingly, since this action merely 

consolidates these airspace areas into 

one airspace designation and has 

inconsequential impact on aircraft 

operations in the area, notice and public 

procedure under 5 U.S.C. 553(b) are 

unnecessary. 

Class E airspace designations for 

airspace extending upward from 700 

feet or more above the surface of the 

earth are published in paragraph 6005 of 

FAA Order 7400.9N, dated September 1, 

2005, and effective September 16, 2005, 

which is incorporated by reference in 14 

CFR 71.1. The Class E airspace 

designation listed in this document will 

be published subsequently in the Order. 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. Therefore, this regulation: (1) Is 

not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

Regulatory Evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that will only affect air 

traffic procedures and air navigation it 

is certified that this rule will not have 

significant economic impact on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporated by reference, 

Navigation (air). 

Adoption of the Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR Part 71 as follows: 

PART 71—[AMENDED] 

■ 1. The authority citation for Part 71 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854; 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of the Federal Aviation 

Administration Order 7400.9N, 

Airspace Designations and Reporting 

Points, dated September 1, 2005 and 

effective September 16, 2005, is 

amended as follows: 

Paragraph 6005 Class E airspace areas 

extending from 700 feet of more above the 

surface of the earth. 

* * * * * 

AEA NY E5 Cortland, NY [Removed] 

AEA NY E5 Ithaca, NY [Removed] 

AEA NY E5 Elmira, NY [Removed] 

AEA NY E5 Endicott, NY [Removed] 

AEA PA E5 Sayre, PA [Removed] 

* * * * * 

Issued in Jamaica, New York on October 

11, 2005. 

John G. McCartney, 

Acting Area Director, Eastern Terminal 

Operations. 

[FR Doc. 05–21321 Filed 10–25–05; 8:45 am] 

BILLING CODE 4910–13–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. 2005P–0397] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

Cystic Fibrosis Transmembrane 

Conductance Regulator Gene Mutation 

Detection System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

cystic fibrosis transmembrane 

conductance regulator (CFTR) gene 

Federal Register / Vol. 70, No. 206 / Wednesday, October 26, 2005 / Rules and Regulations 61737 

mutation detection systems 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: 

CFTR Gene Mutation Detection 

Systems.’’ 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 announcing the 

availability of the guidance document 

that will serve as the special control for 

the device. 

DATES: This final rule is effective 

November 25, 2005. The classification 

was effective May 9, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Zivana Tezak, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0597. 

SUPPLEMENTARY INFORMATION: 

I. What is the Background of this 

Rulemaking? 

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 class 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 part 807 (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 notice in the Federal Register 

announcing such classification (section 

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

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

the act, FDA issued an order on April 

1, 2005, classifying the Tm Bioscience 

Corp., Tag-ItTM Cystic Fibrosis Kit into 

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 

April 5, 2005, Tm Bioscience Corp., 

submitted a petition requesting 

classification of the Tag-ItTM Cystic 

Fibrosis Kit under section 513(f)(2) of 

the act. The manufacturer recommended 

that the device be classified into class II. 

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 

Tm Bioscience Corp., Tag-ItTM Cystic 

Fibrosis Kit can be classified into class 

II with the establishment of special 

controls. FDA believes these special 

controls will provide reasonable 

assurance of safety and effectiveness of 

the device. 

The device is assigned the generic 

name ‘‘cystic fibrosis transmembrane 

conductance regulator (CFTR) gene 

mutation detection system’’ and it is 

identified as 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 stand-alone diagnostic 

purposes, prenatal diagnostic, preimplantation, or population screening. 

CFTR gene mutation detection systems 

may consist of different reagents and 

instruments, including polymerase 

chain reaction (PCR) primers, 

hybridization matrices, thermal cyclers, 

sequencers, signal detection 

instruments, and software packages. 

FDA has identified the risks to health 

associated specifically with this type of 

device as improper clinical 

recommendations and improper 

medical patient management due to 

failure of the test to perform as 

indicated or errors in interpretation of 

results. Specifically, in the context of 

carrier-screening in adults, a falsenegative or false-positive result or 

interpretation could lead to inaccurate 

estimates of a couple’s risk of having a 

child with cystic fibrosis. In the context 

of assisting in the diagnosis of CF in 

newborns and children, a false-negative 

could lead to a delay in the definitive 

diagnosis and treatment; a false-positive 

could lead to unnecessary or 

inappropriate treatment. 

FDA believes that the class II special 

controls guidance document aids in 

mitigating the potential risks to health 

by providing recommendations for 

validation of performance 

characteristics, as well as for labeling. 

The guidance document also provides 

information on how to meet premarket 

(510(k)) submission requirements for the 

device. FDA believes that the special 

controls guidance document, in 

addition to general controls, addresses 

the risks to health identified previously 

and provides reasonable assurance of 

the safety and effectiveness of the 

device. Therefore, on May 9, 2005, FDA 

issued an order to the petitioner 

classifying the device into class II. FDA 

is codifying this device by adding 

§ 866.5900. 

Following the effective date of this 

final rule, any firm submitting a 510(k) 

premarket notification for a CFTR gene 

mutation detection system will need to 

address the issues covered in the special 

controls guidance. However, the firm 

need only show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurance of safety and effectiveness. 

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. For this type 

of device, FDA has determined that 

premarket notification is necessary to 

provide reasonable assurance of the 

safety and effectiveness of the device 

and, therefore, the type of device is not 

exempt from premarket notification 

requirements. Persons who intend to 

market this type of device must submit 

to FDA a premarket notification, prior to 

marketing the device, which contains 

information about the CFTR gene 

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.