This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

67652 

Vol. 70, No. 215 

Tuesday, November 8, 2005 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 874 

[Docket No. 2005N–0346] 

Ear, Nose, and Throat Devices; 

Tinnitus Masker; Designation of 

Special Controls 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend the classification regulations of 

tinnitus masker devices in order to 

specify a special control for the device. 

The agency is taking this action on its 

own initiative. This action is being 

taken under the Federal Food, Drug, and 

Cosmetic Act (the act), as amended by 

the Safe Medical Devices Act of 1990 

(SMDA), and the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA). Elsewhere in this issue 

of the Federal Register, FDA is 

publishing a notice of availability of the 

draft guidance document that the 

agency proposes to use as a special 

control for the device. 

DATES: Submit written or electronic 

comments on the proposed rule by 

February 6, 2006. See section XI of this 

document for the proposed effective 

date of a final rule based on this 

document. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2005N–0346, 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

docket number or regulatory 

information number for this rulemaking. 

All comments received may be posted 

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

ohrms/dockets/default.htm, including 

any personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Teresa Cygnarowicz, Center for Devices 

and Radiological Health (HFZ–460), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–2980. 

SUPPLEMENTARY INFORMATION: 

I. Statutory and Regulatory Authorities 

The act (21 U.S.C. 301 et. seq.), as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Public Law 94–295), 

SMDA (Public Law 101–629), FDAMA 

(Public Law 105–115), and the Medical 

Device User Fee and Modernization Act 

(Public Law 107–250), established a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the act (21 U.S.C. 

360c) established three categories 

(classes) of devices, defined by the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under section 513 of the act, FDA 

refers to devices that were in 

commercial distribution before May 28, 

1976 (the date of enactment of the 1976 

amendments), as preamendments 

devices. FDA classifies these devices 

after it takes the following steps: (1) 

Receives a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) publishes the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) publishes 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution before May 28, 1976, 

generally referred to as postamendments 

devices, are classified automatically by 

statute (section 513(f) of the act) into 

class III without any FDA rulemaking 

process. Those devices remain in class 

III until FDA does the following: (1) 

Reclassifies the device into class I or II; 

(2) issues an order classifying the device 

into class I or II in accordance with 

section 513(f)(2) of the act; or (3) issues 

an order finding the device to be 

substantially equivalent, in accordance 

with section 513(i) of the act, to a legally 

marketed device that has been classified 

into class I or class II. 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 the 

regulations. 

Under the 1976 amendments, class II 

devices were defined as devices for 

which there was insufficient 

information to show that general 

controls themselves would provide 

reasonable assurance of safety and 

effectiveness, but for which there was 

sufficient information to establish 

performance standards to provide such 

assurance. SMDA broadened the 

definition of class II devices to mean 

those devices for which the general 

Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Proposed Rules 67653 

controls by themselves are insufficient 

to provide reasonable assurance of 

safety and effectiveness, but for which 

there is sufficient information to 

establish special controls to provide 

such assurance, including performance 

standards, postmarket surveillance, 

patient registries, development and 

dissemination of guidelines, 

recommendations, and any other 

appropriate actions the agency deems 

necessary (section 513(a)(1)(B) of the 

act). 

II. Regulatory History of the Devices 

In the Federal Register of March 31, 

2000 (65 FR 17138), FDA issued a final 

rule reclassifying 28 preamendments 

devices from class III (premarket 

approval) into class II (special controls). 

FDA also identified a summary of FDA 

guidance special controls that the 

agency believes will reasonably ensure 

the safety and effectiveness of the 

devices. For the tinnitus masker device 

(TMD), FDA identified labeling as the 

special control. 

III. Proposed Rule 

FDA is proposing to amend the 

reclassification regulation of TMDs in 

order to designate a special control for 

these devices. FDA has now developed 

a guidance document for the device and, 

under the SMDA provisions, is 

proposing to designate the special 

controls that, in addition to general 

controls, the agency believes will 

reasonably assure the safety and 

effectiveness of these devices. FDA is 

identifying the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Tinnitus Masker 

Devices’’ as the proposed special 

control. 

Following the effective date of a final 

rule based on this proposed rule, any 

firm submitting a premarket notification 

(510(k)) for a new TMD will need to 

address the issues covered in the special 

control guidance. However, the firm 

needs only to show that its device meets 

the recommendations of the guidance or 

in some other way provides equivalent 

assurance of safety and effectiveness. 

IV. Risks to Health 

FDA has identified the following risks 

to health associated with the device in 

the ‘‘Class II Special Controls Guidance 

Document: Tinnitus Masker Devices.’’

The first column in table 1 of this 

document shows the identified risks. 

TABLE 1.—RISKS TO HEALTH AND

RECOMMENDED MITIGATION MEASURES

Risks to Health 

Recommended 

Mitigation 

Measures 

Side effects, including worsening tinnitus Section 8. Clinical Testing 

Section 9. Labeling 

Change in hearing Section 7. Preclinical Testing 

Section 8. Clinical Testing 

Section 9. Labeling 

Adverse tissue reaction Section 7. Preclinical Testing 

Electrical hazards Section 7. Preclinical Testing 

Tissue heating or cavitation 

(ultrasound TMDs only) 

Section 7. Preclinical Testing 

Improper use Section 9. Labeling 

V. Special Controls 

FDA believes that, in addition to 

general controls, the class II special 

controls guidance document entitled 

‘‘Class II Special Controls Guidance 

Document: Tinnitus Masker Devices’’

are adequate controls to address the 

risks to health described in section IV of 

this document. The class II special 

controls guidance document provides 

information on how to control the risks 

to health of device side effects, 

including worsening tinnitus, change in 

hearing, adverse tissue reaction, 

electrical hazards, tissue heating or 

cavitation (ultrasound TMDs only), and 

improper use. The draft guidance 

document contains specific 

recommendations with regard to device 

performance testing and other 

information in a 510(k) submission. In 

table 1 of this document, FDA has 

identified the risks to health associated 

with the use of the device in the first 

column and the recommended 

mitigation measures identified in the 

class II special controls guidance 

document in the second column. These 

recommendations will also help ensure 

that the device has appropriate 

performance characteristics and labeling 

for its use. 

Following the effective date of a final 

rule based on this proposed rule, any 

firm submitting a 510(k) for a TMD 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. 

VI. 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. 

VII. Analysis of Impacts 

FDA has examined the impacts of the 

proposed 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 proposed rule is 

consistent with the regulatory 

philosophy and principles identified in 

the Executive order. In addition, the 

proposed rule is not a significant 

regulatory action as defined by the 

Executive order and so is 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. The purpose of this proposed 

rule is to designate a special control for 

these devices. FDA has designated 

guidance documents as the special 

controls. FDA believes that 

manufacturers, including small 

manufacturers, are already substantially 

in compliance with the 

recommendations in the guidance 

documents and they will not add 

substantially to the information 

manufacturers presently submit. FDA, 

therefore, believes that the rule will 

impose no significant economic impact 

on any small entities. The agency, 

therefore certifies that this proposed 

rule will not have a significant 

economic impact on a substantial 

number of small entities. In addition, 

this proposed rule will not impose costs 

of $100 million or more on either the 

private sector or State, local, and tribal 

governments in the aggregate and, 

therefore, a summary statement or 

67654 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Proposed Rules 

analysis under section 202(a) of the 

Unfunded Mandates Reform Act of 1995 

is not required. 

VIII. 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. 

IX. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed 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 tentatively concludes that 

the special controls guidance document 

does not contain new 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 document entitled ‘‘Class 

II Special Controls Guidance Document: 

Tinnitus Masker Devices.’’

X. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this proposed rule. 

Submit a single copy of electronic 

comments to http://www.fda.gov/ 

dockets/ecomments or two paper copies 

of any written comments, except that 

individuals may submit one paper 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. 

XI. Proposed Implementation Plan 

FDA proposes that any final 

regulation that may issue based on this 

proposal become effective 30 days after 

its date of publication in the Federal 

Register. Following the effective date of 

a final rule exempting the device, 

manufacturers of TMDs will need to 

address the issues covered in this 

special controls guidance. However, the 

manufacturer need only show that its 

device meets the recommendations of 

the guidance or in some other way 

provides equivalent assurances of safety 

and effectiveness. 

List of Subjects in 21 CFR Part 874 

Medical devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 874 be amended as follows: 

PART 874—EAR, NOSE, AND THROAT 

DEVICES 

■ 1. The authority citation for 21 CFR 

part 874 continues to read as follows: 

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

360j, 371. 

■ 2. Section 874.1 is amended by 

revising paragraph (e) to read as follows: 

§ 874.1 Scope. 

* * * * * 

(e) Guidance documents in this part 

may be obtained on the Internet at 

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

■ 3. Section 874. 3400 is amended by 

revising paragraph (b) to read as follows: 

§ 874.3400 Tinnitus masker. 

* * * * * 

(b) Classification. Class II (special 

controls). The special control for these 

devices is FDA’s ‘‘Class II Special 

Controls Guidance Document: Tinnitus 

Masker Devices.’’

Dated: October 7, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–22269 Filed 11–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 948 

[WV–108–FOR] 

West Virginia Regulatory Program 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement (OSM), 

Interior. 

ACTION: Proposed rule; public comment 

period and opportunity for public 

hearing on proposed amendment. 

SUMMARY: We are announcing receipt of 

a proposed amendment to the West 

Virginia regulatory program (the West 

Virginia program) under the Surface 

Mining Control and Reclamation Act of 

1977 (SMCRA or the Act). West Virginia 

proposes to revise its Code of State 

Regulations (CSR) concerning surety 

bonds. The amendment is intended to 

provide the State with an alternative 

source of reliable financial information 

about the surety, and to allow sureties 

that are licensed and in good financial 

condition but are not currently listed 

with the U.S. Department of the 

Treasury as an acceptable surety of 

Federal bonds to provide surety bonds 

to the coal industry in West Virginia. 

The proposed amendment was 

authorized by the West Virginia 

Secretary of State as an emergency rule 

under the State’s Administrative 

Procedures Act. 

DATES: We will accept written 

comments on this amendment until 4 

p.m. (local time), on December 8, 2005. 

If requested, we will hold a public 

hearing on the amendment on December 

5, 2005. We will accept requests to 

speak at a hearing until 4 p.m. (local 

time), on November 23, 2005. 

ADDRESSES: You may submit comments, 

identified by WV–108–FOR, by any of 

the following methods: 

• E-mail: chfo@osmre.gov. Include 

WV–108–FOR in the subject line of the 

message; 

• Mail/Hand Delivery: Mr. Roger W. 

Calhoun, Director, Charleston Field 

Office, Office of Surface Mining 

Reclamation and Enforcement, 1027 

Virginia Street, East, Charleston, West 

Virginia 25301; or 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Instructions: All submissions received 

must include the agency docket number 

for this rulemaking. For detailed 

instructions on submitting comments 

and additional information on the 

rulemaking process, see the ‘‘Public 

Comment Procedures’’ heading in the 

SUPPLEMENTARY INFORMATION section of 

this document. You may also request to 

speak at a public hearing by any of the 

methods listed above or by contacting 

the individual listed under FOR FURTHER

INFORMATION CONTACT. 

Docket: You may review copies of the 

West Virginia program, this amendment, 

a listing of any scheduled public 

hearings, and all written comments 

received in response to this document at 

the addresses listed below during 

normal business hours, Monday through 

Friday, excluding holidays. You may 

also receive one free copy of this 

amendment by contacting OSM’s 

Charleston Field Office listed below. 

Mr. Roger W. Calhoun, Director, 

Charleston Field Office, Office of