56932 Federal Register / Vol. 69, No. 184 / Thursday, September 23, 2004 / Rules and Regulations 

1This definition does not include minivans and 

sport utility vehicles.

2The only change since 1968 was the addition of 

a provision regarding retreaded tires in 1994.

3 In the United States, six tire manufacturers sell 

nearly 200 million passenger car replacement tires 

every year. Almost three-fourths (72%) of these tires 

are sold through independent tire dealers, including 

chain stores like Tire Kingdom and NTB. Mass 

merchandisers like Wal-Mart, Sears, and K-Mart 

account for 18% of replacement tire sales. 

Company-owned stores (e.g., Goodyear and 

Firestone), service stations, new car dealers, and, 

more recently, the Internet, account for the 

remainder.

4NHTSA’s Uniform Tire Quality Grading System 

regulations (‘‘NHTSA regulations’’) set standards for 

treadwear, traction, and temperature ratings, giving 

consumers the ability to compare the quality of one 

tire with that of another. See 49 CFR 575.104. 

NHTSA’s New Pneumatic Tires for Light Vehicles 

regulations, 49 CFR 571.139 (TREAD Act 

regulations), require disclosure on the tire of, 

among other things, the tire’s size, maximum 

inflation pressure, maximum load, generic name of 

cord material, number of plies, whether it has radial 

plies, and whether it is tube or tubeless.

upward from 700 feet or more above the 

surface of the earth are published in 

paragraph 6005 of FAA Order 7400.9L 

dated September 2, 2003, and effective 

September 16, 2003, 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 Rule 

This amendment to 14 CFR part 71 

modifies Class E airspace at Albert Lea, 

MN, to accommodate aircraft executing 

instrument flight procedures into and 

out of Albert Lea Municipal Airport. 

The area will be depicted on 

appropriate aeronautical charts. 

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 

traffic procedures and air navigation, it 

is certified that this rule will not have 

a 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, Incorporation 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—DESIGNATION OF CLASS A, 

CLASS B, CLASS C, CLASS E, 

AIRSPACE AREAS; AIRWAYS; 

ROUTES; AND REPORTING POINTS

■ 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 95665, 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 7400.9L, Airspace 

Designations and Reporting Points, 

dated September 2, 2003, and effective 

September 16, 2003, is amended as 

follows:

* * * * *

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface of the earth.

* * * * *

AGL MN E5 Albert Lea, MN [Revised] 

Albert Lea Municipal Airport, MN 

(Lat. 43°40′54′′ N., long.93°22′02′′ W.)

That airspace extending upward from 700 

feet above the surface within a 6.5-mile 

radius of the Albert Lea Municipal Airport.

* * * * *

Issued in Des Plaines, Illinois, on 

September 9, 2004. 

Keith A. Thompson, 

Area Staff Manager, Central Terminal 

Operations.

[FR Doc. 04–21395 Filed 9–22–04; 8:45 am] 

BILLING CODE 4910–13–M

FEDERAL TRADE COMMISSION

16 CFR Part 228 

Tire Advertising and Labeling Guides

AGENCY: Federal Trade Commission 

(‘‘FTC’’ or ‘‘Commission’’).

ACTION: Final decision.

SUMMARY: The Commission previously 

announced its intention to review and 

seek public comment on its Tire 

Advertising and Labeling Guides (‘‘Tire 

Guides’’ or ‘‘Guides’’). That review has 

been completed, and this document 

announces the Commission’s decision 

to rescind the Guides.

DATES: Effective Date: September 23, 

2004.

ADDRESSES: Requests for copies of this 

document should be sent to the 

Consumer Response Center, Room 130, 

Federal Trade Commission, 600 

Pennsylvania Ave., NW., Washington, 

DC 20580. The document is available on 

the Internet at the Commission’s Web 

site http://www.ftc.gov.

FOR FURTHER INFORMATION CONTACT:

Jonathan L. Kessler, Federal Trade 

Commission, 1111 Superior Avenue, 

Suite 200, Cleveland, Ohio, 44114, 

telephone number (216) 263–3436, Email <jkessler@ftc.gov>.

SUPPLEMENTARY INFORMATION: 

I. Overview of FTC Tire Advertising 

Regulation and the Consumer Tire 

Industry 

The Commission’s Tire Guides 

address aspects of the marketing, use, 

and servicing of tires ‘‘for use on 

passenger automobiles, station wagons, 

and similar vehicles.’’ 1 16 CFR 228.0. 

The Commission first promulgated 

Trade Practice Rules For The Tire 

Industry in 1936. The Tire Guides in 

their current form were published in 

1968.2 Commission hearings in the mid1960s revealed problems with deceptive 

advertising by sellers, and the 

Commission concluded that consumers 

lacked the information needed to make 

informed purchasing decisions. The 

problems appear to have revolved 

around the lack of standard definitions 

for the terms ‘‘ply’’ and ‘‘ply rated,’’ the 

lack of recognized standards for safety 

and quality, and pricing practices.

The tire industry, however, has 

changed considerably in the last 35 

years. First, in 1968, bias ply tires were 

standard on passenger cars. Today, 

radial tires dominate the consumer 

market, with bias tires relegated to large 

trucks and historical vehicles. As a 

result, factors such as the number of 

plies in a tire or its cord material are no 

longer relevant to consumer decision 

making. Second, in 1968, consumers 

bought tires at full-service gas stations 

or locally-owned stores that carried only 

one brand of tire. Today, sales also 

occur through national retailers, 

regional tire stores, new car dealerships, 

and the Internet.3 These new retail 

establishments offer multiple brands, 

tread patterns, and mileage warranties. 

Moreover, prices for these tires are 

widely advertised, often in full-page 

newspaper ads or inserts. As a result, 

consumers have more choices of tires 

and more information about prices and 

options. Third, in 1968, no government 

or industry association established 

standards for measuring tire quality or 

insuring safety. Today, the National 

Highway Traffic Safety Administration 

(‘‘NHTSA’’) oversees the industry and 

has promulgated comprehensive 

regulations requiring disclosure of 

important safety and quality features.4

Federal Register / Vol. 69, No. 184 / Thursday, September 23, 2004 / Rules and Regulations 56933

5The Commission periodically reviews its rules 

and guides. These reviews seek and assess 

information about the costs and benefits of the rules 

and guides, as well as their regulatory and 

economic impact. The information obtained assists 

the Commission in identifying rules and guides that 

warrant modification or rescission. In this instance, 

the Commission sought comments on, among other 

things: the economic impact of and the continuing 

need for the Guides; possible conflicts between the 

Guides and other federal, state, or local laws and 

regulations; and the effect of any technological, 

economic, or other industry changes on the Guides.

6Comments came from the Rubber Manufacturers 

Association, the National Automobile Dealers 

Association, and the Tire Industry Association.

7Letter dated October 24, 2003, from Ann Wilson, 

Rubber Manufacturers Association, to Secretary, 

Federal Trade Commission, at 2.

8The comments differed on whether to revise 

these sections or delete them entirely, however.

9 15 U.S.C. 45.

10Section 228.0 contains definitions and Section 

228.0–1 provides ‘‘[u]se of guide principles.’’

Sections 228.1 through 228.19 are the substantive 

sections.

11The Guides recognize the unique features of 

radials and allow the ply count disclosure to be 

satisfied with just the statement ‘‘radial ply.’’ 16 

CFR 228.2(b)(1) and (2).

12Tire ads for name-brand tires almost always 

state a mileage warranty. Such warranties provide 

additional, albeit non-specific, information about a 

tire’s quality.

13Section 5 of the FTC Act, 15 U.S.C. 45, 

prohibits, among other things, deceptive acts or 

practices. The substantiation doctrine requires 

advertisers to have reasonable substantiation for 

claims in advertisements at the time the 

advertisement is published.

II. Regulatory Review of the Guides and 

Public Comment 

The Commission reviewed the Tire 

Guides as part of its continuing review 

of all current rules and guides.5 On 

August 25, 2003, the Commission 

published a Federal Register notice 

seeking comments about the costs and 

benefits of the Guides. Three written 

comments were received, all in favor of 

significantly revising the Guides.6 For 

example, one comment stated: ‘‘[A]s 

currently written, the Guides have 

limited utility to tire manufacturers, tire 

dealers and tire consumers, appear to be 

redundant with other consumer 

protection laws, and have been 

superseded in part by regulations issued 

by another government agency.’’ 7 All 

three comments substantially agreed on 

four points:

(1) If retained, the Guides should be 

expanded from passenger car and 

station wagon tires to include tires for 

minivans, sport utility vehicles, and 

other light trucks. 

(2) Section 228.2 is obsolete and in 

need of substantial revision or deletion. 

This provision requires that ads making 

comparative quality claims across tire 

brands also disclose that no generally 

accepted standards of tire quality exist. 

In 1978, however, NHTSA promulgated 

its Uniform Tire Quality Grading 

System, which establishes tests and 

criteria for grading tire quality. 

(3) The ply count and cord material 

provisions of Sections 228.6 and 228.7 

are obsolete because of the market 

change from bias ply to radial tires 

(nearly 100% of tires sold for consumer 

vehicles are radials).8

(4) Ads for used and retreaded tires 

should continue to disclose that those 

tires are not new, as required by Section 

228.9. 

Not all comments addressed each 

section of the Guides, but the overall 

suggestion of each comment was to 

revise and retain the Guides rather than 

to rescind them.

III. Determination To Rescind the 

Guides 

After reviewing the Tire Guides, the 

consumer tire industry, the NHTSA 

regulations, the above-referenced 

comments, and other industry guides, 

the Commission has decided to rescind 

the Guides. This decision is based on 

the fact that many provisions in the 

Guides duplicate other laws and 

regulations or are obsolete. In addition, 

some provisions describe conduct that 

is addressed by section 5 of the FTC 

Act, which generally prohibits unfair or 

deceptive acts or practices.9 A 

description and analysis of each of the 

Guides’ nineteen substantive provisions 

follows.10

Section 228.1 requires point-of-sale 

disclosure of the load carrying capacity 

of the tire, the composition of the cord 

material and the actual number of plies. 

It also provides for permanent 

disclosures on the tire itself of the tire’s 

size, whether it is tube or tubeless, and 

its number of plies. This section also 

requires disclosure via a label or tag on 

the tire of its cord material, loadcarrying capacity, and inflation 

pressure. Today, however, NHTSA 

regulations require this information on 

the tire. Moreover, with radial tires 

dominating the market, the ply count 

and cord material disclosures provide 

no meaningful information to 

consumers buying tires for personal, 

family, or household use; NHTSA 

requires this information because it is 

important to tire retreaders.11

Section 228.2 prohibits the use of 

terms like ‘‘line,’’ ‘‘level,’’ and 

‘‘premium’’ without also disclosing the 

lack of any ‘‘industry-wide or other 

accepted system of quality standards or 

grading of industry products’ and that 

any representations of grade or level 

only apply to the marketer’s brand. 

Marketers are prohibited from 

describing tires as ‘‘first line’’ ‘‘unless 

the products so described are the best 

products, exclusive of premium quality 

products embodying special features, of 

the manufacturer or brand name 

distributor.’’ § 228.2 (d). Today, 

however, NHTSA regulations enable 

consumers to compare tires on several 

measures of quality: treadwear, traction, 

load capability, and temperature. 

Consumers also have the benefit of tire 

warranties, which typically warrant a 

tire for a particular number of miles.12

Section 228.3 complements Section 

228.2 by prohibiting a manufacturer 

from using terms that imply that one of 

its tires is better than another unless the 

first is actually superior. Section 228.4 

prohibits describing a tire as ‘‘original 

equipment’’ unless it is currently used 

on new cars or the manufacturer 

discloses when the tire was last used on 

new cars. Under the Guides, original 

equipment tires are considered to be 

‘‘the same brand and quality tires used 

generally as original equipment on new 

current models of vehicles of domestic 

manufacture.’’ There is no evidence, 

however, whether consumers still 

understand the term ‘‘original 

equipment’’ in this way or have changed 

their understanding over the years, and 

none of the commenters mentioned this 

section. Section 228.5 prohibits any 

other quality or performance claim 

unless the claim maker has test results 

to substantiate the claim. Today, most of 

these claims would clearly be covered 

by the FTC’s deception standard and 

substantiation doctrine.13

Sections 228.6 and 228.7 govern 

representations of ‘‘ply count,’’ ‘‘plies,’’

‘‘ply rating,’’ and ‘‘cord material.’’ These 

factors were important indicators of tire 

quality with bias ply tires. Today, 

however, radial tires make these 

measures far less meaningful; NHTSA 

requires them only because they affect 

the retread process. In their place, 

NHTSA regulations require more direct 

information about tire quality. 

Sections 228.8, 228.9, and 228.11 

require disclosures in ads for tires that 

are used or imperfect. In 1968, 

consumers who did not want to pay for 

new, perfect tires could purchase used, 

retreaded, or blemished tires. Today, 

however, these tires are seldom found in 

the consumer market. (Large truck tires, 

such as those for semis, are often 

retreaded, and retreads account for as 

much as 60% of that market.) Moreover, 

if a business were to sell a used, 

blemished, or defective tire without 

proper disclosures, such conduct would 

likely constitute deception in violation 

of section 5 of the FTC Act. 

Section 228.10 requires disclosure if 

an advertised tire is a discontinued or 

56934 Federal Register / Vol. 69, No. 184 / Thursday, September 23, 2004 / Rules and Regulations 

14Letter dated October 24, 2003 from Becky 

MacDicken, Tire Industry Association, to Secretary, 

Federal Trade Commission, at 3.

obsolete model. Tire manufacturers 

today, however, often change models, so 

it is questionable whether such 

information is material to consumers. 

None of the commenters discussed this 

provision and there is no evidence 

whether consumers are concerned about 

or would be adversely affected by 

purchasing a tire that is being 

discontinued. If problems were to 

surface in this area, they likely could be 

addressed by section 5 of the FTC Act. 

Sections 228.12 and 228.13 address 

advertisements that use pictures or 

racing themes. Pictures must be of the 

tire advertised and ads using racing 

themes must disclose that the tires on 

race cars ‘‘are not generally available all 

purpose tires, unless such is the fact.’’

As in 1968, pictures and video can be 

used today to misrepresent the qualities 

of tires, but any material 

misrepresentations would violate 

section 5 of the FTC Act. 

Sections 228.14 and 228.15 address 

price advertising. Section 228.14 

prohibits bait advertising, and Section 

228.15 addresses price comparisons. 

Although both sections address 

concerns that may be relevant to the 

current tire market, the Commission has 

published guides devoted to both issues. 

See 16 CFR 238 (bait advertising) and 16 

CFR 233 (deceptive pricing). These 

guides should provide adequate 

information for tire industry members to 

understand how section 5 of the FTC 

Act applies to their products, making 

Sections 228.14 and 228.15 redundant. 

Section 228.16 requires ads 

containing guarantees to disclose details 

of those guarantees, including how price 

adjustments will be calculated if a tire 

fails during the guarantee period. 

Today, however, warranties must be 

available at a store for inspection before 

purchase. 16 CFR 702 (rule on the 

Presale Availability of Written Warranty 

Terms). Requiring disclosure of 

guarantee details in ads themselves thus 

appears unnecessary. Advertising 

claims about warranties and guarantees 

are also addressed by the Guides for the 

Advertising of Warranties and 

Guarantees, 16 CFR 239. 

Section 228.17 prohibits absolute 

performance or safety claims such as 

‘‘blowout proof’’ or ‘‘skid proof’’ unless 

the claims are true under all driving 

conditions. Any problems attributable to 

these or similar claims can be addressed 

by section 5 of the FTC Act. 

Section 228.18 prohibits claims that 

deceive purchasers or prospective 

purchasers in any material respect. Even 

if updated, this section would still only 

restate established law and not provide 

additional guidance to the tire industry.

Section 228.19 requires that ads for 

metal studded snow tires disclose that 

their use is illegal in some places. Nonmetal studded mud and snow tires and 

all weather tires, however, have made 

metal studded tires far less common 

now than in 1968. 

In sum, the Commission’s review has 

produced no clear reason for retaining 

the Guides. Even if revised as the 

comments suggested, the Guides would 

not provide consumers with any 

information not already required to be 

available to them by other laws and 

regulations. Moreover, neither the 

comments nor the Commission staff’s 

own review of tire advertising has 

identified benefits to consumers from 

the existing Guides or areas where 

businesses are in particular need of 

Commission guidance. Indeed, one 

comment, after noting several changes 

in the industry that would make 

significant revisions necessary if the 

Guides were to be retained, admitted 

that ‘‘[t]hese changes will not make a 

huge difference to consumers. They will 

simply update the Guides to reflect 

today’s market.’’14 Because the vast 

majority of Tire Guide provisions are 

adequately addressed by other laws and 

regulations (including NHTSA 

regulations and Section 5 of the Federal 

Trade Commission Act) or have been 

rendered obsolete because of changes in 

the market, the Commission has 

determined to rescind the Guides.

List of Subjects in 16 CFR Part 228 

Advertising, Automobile tires, Trade 

practices.

PART 228—[REMOVED]

■ The Commission, under authority of 

sections 5(a)(1) and 6(g) of the Federal 

Trade Commission Act, 15 U.S.C. 

45(a)(1) and 46(g), amends Chapter 1 of 

Title 16 of the Code of Federal 

Regulations by removing part 228.

By direction of the Commission, 

Commissioner Leibowitz not participating. 

Donald S. Clark, 

Secretary.

[FR Doc. 04–21404 Filed 9–22–04; 8:45 am] 

BILLING CODE 6750–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. 2004N–0370]

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Beta-Glucan Serological Assay

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

beta-glucan serological reagent device 

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: Serological Assays 

for the Detection of Beta-Glucan.’’ The 

agency is taking this action in response 

to a petition submitted under the 

Federal Food, Drug, and Cosmetic Act 

(the act) as amended by the Medical 

Device Amendments of 1976 (the 1976 

amendments), the Safe Medical Devices 

Act of 1990, the Food and Drug 

Administration Modernization Act of 

1997, and the Medical Device User Fee 

and Modernization Act of 2002. 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 becomes effective 

October 25, 2004. The classification was 

effective May 21, 2004.

FOR FURTHER INFORMATION CONTACT:

Freddie M. Poole, Center for Devices 

and Radiological Health (HFZ–440), 

Food and Drug Administration, 2098 

Gaither Rd., Rockville, MD 20850, 301–

594–2096, ext. 111.

SUPPLEMENTARY INFORMATION:

I. Background

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

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 1976 

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