5440 Federal Register / Vol. 69, No. 23 / Wednesday, February 4, 2004 / Proposed Rules 

1 15 U.S.C. 7601–7610 (Pub. L. 108–164).

2 Id. at 7601.

3 Id. at 7601, 7603.

4 Id. at 7609.

5 Id. at 7607.

6 Id. at 7608.

7 Id.

8 16 CFR part 456.

9See Health Products Research (VIS)—Annual 

2000 Year-End Consumer Contact Lens Survey 

(cited in ‘‘Trends in Contact Lenses & Lens Care,’’ 

The Bausch & Lomb Annual Report to Vision Care 

Professionals (Dec. 2001)).

FEDERAL TRADE COMMISSION

16 CFR Parts 315 and 456 

RIN 3084–AA95 

Contact Lens Rule; Ophthalmic 

Practice Rules

AGENCY: Federal Trade Commission.

ACTION: Notice of proposed rulemaking; 

request for public comment. 

SUMMARY: In this document, the Federal 

Trade Commission (the ‘‘Commission’’ 

or ‘‘FTC’’) issues a Notice of Proposed 

Rulemaking seeking comment on its 

proposed rule to implement the Fairness 

to Contact Lens Consumers Act (‘‘the 

Act’’), which provides for the 

availability of contact lens prescriptions 

to patients and the verification of 

contact lens prescriptions by 

prescribers. This document also 

proposes two clerical amendments to 

the Commission’s Ophthalmic Practice 

Rules, which are designed to clarify the 

distinction between those Rules and the 

proposed Contact Lens Rule.

DATES: Public comments must be 

received on or before April 5, 2004.

ADDRESSES: Comments should refer to 

‘‘Contact Lens Rule, Project No. 

R411002.’’ Comments filed in paper 

form should be mailed or delivered, as 

prescribed in the SUPPLEMENTARY

INFORMATION section, to the following 

address: Federal Trade Commission/

Office of the Secretary, Room 159–H, 

(Annex A) 600 Pennsylvania Avenue, 

NW., Washington, DC 20580. Because 

paper mail in the Washington area and 

at the Agency is subject to delay, please 

consider submitting your comments via 

electronic mail. Comments filed in 

electronic form (except comments 

containing any confidential material) 

should be sent, as prescribed in the 

SUPPLEMENTARY INFORMATION section, to 

the following e-mail box: 

contactlensrule@ftc.gov. All Federal 

Government agency rulemaking 

initiatives are also available online at 

http://www.regulations.gov.

Comments on any proposed filing, 

recordkeeping, or disclosure 

requirements that are subject to 

paperwork burden review under the 

Paperwork Reduction Act should 

additionally be submitted to: Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, New 

Executive Office Building, Room 10102, 

Washington, DC 20503, Attention: Desk 

Officer for Federal Trade Commission, 

as well as to the FTC Secretary at the 

address above.

FOR FURTHER INFORMATION CONTACT:

Thomas Pahl or Kial Young, (202) 326–

2738, contactlensrule@ftc.gov, Federal 

Trade Commission, Bureau of Consumer 

Protection, Division of Advertising 

Practices, 600 Pennsylvania Avenue, 

NW., Washington, DC 20580.

SUPPLEMENTARY INFORMATION: 

I. Background 

Fairness to Contact Lens Consumers Act 

On December 6, 2003, President Bush 

signed the Fairness to Contact Lens 

Consumers Act (‘‘the Act’’).1 Among 

other things, the Act requires that 

prescribers—such as optometrists and 

ophthalmologists—provide contact lens 

prescriptions to their patients upon the 

completion of a contact lens fitting.2

The Act also mandates that prescribers 

verify contact lens prescriptions to 

third-party contact lens sellers who are 

authorized by consumers to seek such 

verification.3 Further, the Act directs 

the Commission to conduct a study to 

examine the strength of competition in 

the sale of prescription contact lenses, 

including an examination of several 

specified issues.4

The Act directs the Commission to 

prescribe implementing rules.5 Any 

violation of the Act or its implementing 

rules constitutes a violation of a rule 

under section 18 of the Federal Trade 

Commission Act, 15 U.S.C. 57a, 

regarding unfair or deceptive acts or 

practices.6 The Act also authorizes the 

Commission to investigate and enforce 

the Act in the same manner, by the same 

means, and with the same jurisdiction, 

powers, and duties, as a trade regulation 

rule under the Federal Trade 

Commission Act.7

The Commission already enforces the 

Ophthalmic Practice Rules.8 These 

Rules primarily require the release of 

eyeglass prescriptions to patients at the 

completion of an eye examination, and 

prohibit eye care practitioners from 

placing certain conditions on such 

release. The Commission today 

proposes two clerical amendments, set 

forth in sections III and XI below, to 

clarify the relationship between the 

Ophthalmic Practices Rules and the 

proposed rule under the Fairness to 

Contact Lens Consumers Act.

II. Overview of the Proposed Contact 

Lens Rule 

Nearly 36 million Americans—almost 

13% of all Americans—wear contact 

lenses.9 The contact lens market in the 

United States is a multi-billion dollar 

market. There are numerous 

manufacturers of contact lenses and 

many different channels of distribution, 

including traditional eye care 

practitioners (e.g., ophthalmologists and 

optometrists), national and regional 

optical chains, mass merchants (e.g., 

Wal-Mart and Costco), and mail order 

and Internet firms.

The contact lens market has 

undergone significant change in recent 

years. The development of disposable 

soft contact lenses, followed by the 

growth of ‘‘alternative’’ retail sources of 

contact lenses (e.g., non-eye care 

practitioners), including mail order and 

Internet firms, and mass merchants, has 

given consumers a greater choice of 

sellers and means of delivery when they 

purchase contact lenses. Such choice 

can have important benefits to 

consumers. Competition among contact 

lens sellers benefits consumers through 

lower prices, greater convenience, and 

improved product quality. 

Key to consumer choice among 

contact lens sellers is the availability of 

the contact lens prescription. To this 

end, the proposed Rule is designed to 

implement the Act’s specific provisions 

regarding the release and verification of 

contact lens prescriptions, and 

otherwise to further the Act’s goals of 

ensuring the availability of such 

prescriptions so that consumers can 

choose among sellers when purchasing 

contact lenses. The proposed Rule 

tracks the language of the Act very 

closely: 

• Section 315.1 describes the scope of 

the regulations under the Act. 

• Section 315.2 sets forth definitions 

for the terms used in the proposed Rule. 

• Section 315.3 requires prescribers 

to provide patients with a copy of their 

contact lens prescription immediately 

upon completion of a contact lens 

fitting, and to provide or verify contact 

lens prescriptions to any third party 

designated by a patient. This section 

further prohibits prescribers from 

placing certain conditions on the release 

or verification of a contact lens 

prescription. 

• Section 315.4 limits the 

circumstances under which a provider 

can require payment for an eye exam 

prior to releasing a contact lens 

prescription to a patient. 

• Section 315.5 requires contact lens 

sellers to either obtain a copy of a 

patient’s prescription, or verify the 

Federal Register / Vol. 69, No. 23 / Wednesday, February 4, 2004 / Proposed Rules 5441

prescription, before selling contact 

lenses, and sets forth procedures for 

obtaining such verification. This section 

also addresses the issue of private label 

contact lenses. 

• Section 315.6 sets minimum 

expiration dates for contact lens 

prescriptions, with an exception for 

cases involving the prescriber’s medical 

judgment with respect to a patient’s 

ocular health. 

• Section 315.7 prohibits certain 

specified parties from representing that 

contact lenses may be obtained without 

a prescription. 

• Section 315.8 prohibits prescribers 

from using or requiring patients to sign 

any waiver or disclaimer of liability for 

the accuracy of an eye examination. 

• Section 315.9 establishes that 

violations of the proposed Rule will be 

treated as violations of a rule defining 

an unfair or deceptive act or practice 

under the FTC Act. 

• Section 315.10 addresses the 

proposed Rule’s severability. 

Following is an overview of the 

proposed Rule, with brief discussions 

where needed. The full text of the 

proposed Rule appears in section X of 

this document. 

Section 315.1 Scope of Regulations 

Part 315, which shall be called the 

‘‘Contact Lens Rule,’’ implements the 

Fairness to Contact Lens Consumers 

Act, codified at 15 U.S.C. 7601–7610. 

The rules in part 315 of Title 16 of the 

Code of Federal Regulations address 

release and verification of contact lens 

prescriptions and related issues in 

implementing the Act. In contrast, the 

rules in part 456 of Title 16 (the 

‘‘Ophthalmic Practices Rules’’ or 

‘‘Eyeglass Rule’’) address the release of 

eyeglass prescriptions and related 

issues. See 16 CFR part 456. 

Section 315.1 describes the basis for, 

and the general scope of, the regulations 

in part 315. It indicates that part 315 

governs contact lens prescriptions and 

related issues, and clarifies that rules 

applicable to eyeglass prescriptions are 

found in part 456. 

Section 315.2 Definitions 

The Act states that a prescription is 

verified if, among other things, the 

prescriber fails to communicate with the 

seller within ‘‘eight business hours, or a 

similar time as defined by [the FTC],’’

after receiving proper verification 

information from the seller. Eight 

business hours’’ is not expressly defined 

in the Act. The purpose of the time 

period, however, is to give prescribers 

an adequate period of time during 

normal office hours to act upon a 

prescription verification request, while 

at the same time allowing sellers to fill 

customer orders expeditiously.

Business hour is defined under the 

proposed Rule to mean an hour between 

9 a.m. and 5 p.m., during a weekday 

(Monday through Friday), excluding 

Federal holidays. For purposes of 

section 315.5(c)(3), ‘‘eight (8) business 

hours’’ shall begin at the time that the 

seller provides the prescription 

verification request to the prescriber and 

conclude after eight (8) business hours 

have elapsed, except that the period for 

verification requests received during 

non-business hours shall begin at 9 a.m. 

on the next weekday that is not a 

Federal holiday. 

A few examples may help clarify how 

eight business hours would be 

calculated under the proposed 

definition: (1) A response to a 

verification request received at 10:30 

a.m. on Monday morning would be 

required by 10:30 a.m. on Tuesday 

morning; (2) a response to a verification 

request received at 10 p.m. on Monday 

night would be required by 9 a.m. on 

Wednesday morning, i.e., eight business 

hours after the verification period 

commences at 9 a.m. on Tuesday 

morning; (3) a response to a verification 

request received at 2 p.m. on Saturday 

afternoon would be required by 9 a.m. 

on Tuesday morning, i.e., eight business 

hours after the verification period 

begins at 9 a.m. on Monday morning; 

and (4) a response to a verification 

request received at 10:30 a.m. in the 

morning on Columbus Day (a Monday) 

would be required by 9 a.m. on 

Wednesday morning, i.e., eight business 

hours after the verification period 

commenced at 9 a.m. on Tuesday 

morning. 

Commission means the Federal Trade 

Commission. 

Contact lens fitting means the process 

that begins after an initial eye 

examination for contact lenses and ends 

when a successful fit has been achieved 

or, in the case of a renewal prescription, 

ends when the prescriber determines 

that no change in the existing 

prescription is required, and such term 

may include: 

(a) an examination to determine lens 

specifications; 

(b) except in the case of a renewal of 

a contact lens prescription, an initial 

evaluation of the fit of the contact lens 

on the eye; and 

(c) medically necessary follow-up 

examinations. 

This definition is taken almost 

verbatim from the Act. 

Contact lens prescription means a 

prescription, issued in accordance with 

State and Federal law, that contains 

sufficient information for the complete 

and accurate filling of a prescription for 

contact lenses, including the following: 

(a) name of the patient; 

(b) date of examination; 

(c) issue date and expiration date of 

prescription; 

(d) name, postal address, telephone 

number, and facsimile telephone 

number of prescriber; 

(e) power, material or manufacturer or 

both of the prescribed contact lens; 

(f) base curve or appropriate 

designation of the prescribed contact 

lens; 

(g) diameter, when appropriate, of the 

prescribed contact lens; and 

(h) in the case of a private label 

contact lens, name of the manufacturer, 

trade name of the private label brand, 

and, if applicable, trade name of 

equivalent brand name. 

This definition is taken almost 

verbatim from the Act. 

Direct communication, as used in 

section 315.5, includes a completed 

communication through telephone, 

facsimile, or electronic mail. This 

definition sets forth the ways in which 

direct communication, as required in 

section 315.5 of the proposed Rule, may 

occur—by telephone, facsimile, or 

electronic mail. The definition further 

requires that the communication 

involve a completed communication 

with the intended recipient. Thus, 

direct communication by telephone 

would require reaching and speaking 

with the intended recipient, or leaving 

a voice message on the telephone 

answering machine of the intended 

recipient. Similarly, direct 

communication by facsimile or 

electronic mail would require that the 

intended recipient receive the facsimile 

or electronic mail message. 

Issue date, as used in section 315.6, 

means the date on which the patient 

receives a copy of the prescription. This 

definition is taken directly from the Act. 

Ophthalmic goods are contact lenses, 

eyeglasses, or any component of 

eyeglasses. This term is not defined in 

the Act, and so it has been defined 

based on similar language in the 

Eyeglass Rule. 

Ophthalmic services are the 

measuring, fitting, and adjusting of 

ophthalmic goods subsequent to an eye 

examination. This term is not defined in 

the Act, and so it has been defined 

based on similar language in the 

Eyeglass Rule. 

Prescriber means, with respect to 

contact lens prescriptions, an 

ophthalmologist, optometrist, or other 

person permitted under State law to 

issue prescriptions for contact lenses in 

compliance with any applicable 

requirements established by the Food 

5442 Federal Register / Vol. 69, No. 23 / Wednesday, February 4, 2004 / Proposed Rules 

10Section 19(d) of the FTC Act, 15 U.S.C. 57b(d).

and Drug Administration. This 

definition is taken directly from the Act.

Private Label Contact Lenses mean 

contact lenses that are sold under the 

label of a seller where the contact lenses 

are identical to lenses made by the same 

manufacturer but sold under the labels 

of other sellers. This definition is 

derived from the Act. 

Section 315.3 Availability of Contact 

Lens Prescriptions to Patients 

The Act requires prescribers to 

provide patients with a copy of their 

contact lens prescription upon 

completion of a contact lens fitting. It 

also mandates that prescribers provide 

or verify contact lens prescriptions to 

third parties authorized to act on behalf 

of patients. The Act further prohibits 

prescribers from refusing to release or 

verify a prescription unless their 

patients purchase contact lenses from 

them, pay a fee in addition to or as part 

of a examination fee, or sign a waiver or 

release of liability. Section 315.3 of the 

proposed Rule is taken almost verbatim 

from the Act. 

Section 315.4 Limits on Requiring 

Immediate Payment 

The Act provides that prescribers can 

require patients to pay a fee for an eye 

examination, fitting, and evaluation 

before the release of a contact lens 

prescription only if the prescriber 

requires immediate payment for an 

examination that reveals that the patient 

does not need contact lenses or other 

ophthalmic goods. The Act treats 

presentation of proof of insurance 

coverage as a type of payment. Section 

315.4 of the proposed Rule is taken 

directly from the Act. 

Section 315.5 Prescriber Verification 

(a) Prescription Requirement 

The Act states that a seller cannot sell 

contact lenses to a customer unless the 

seller has obtained a copy of the 

patient’s contact lens prescription, or 

verified the prescription through a 

direct communication with the 

prescriber. Section 315.5(a) of the 

proposed Rule incorporates these 

preconditions verbatim from the Act. 

(b) Information for Verification 

The Act sets forth with specificity the 

information that a seller must provide to 

the prescriber when seeking verification 

of a contact lens prescription. Under the 

Act, the seller must provide the 

prescriber with the following 

information through direct 

communication: (1) The patient’s full 

name and address; (2) the contact lens 

power, manufacturer, base curve or 

appropriate designation, and diameter 

when appropriate; (3) the quantity of 

lenses ordered; (4) the date of the 

patient request; (5) the date and time of 

the verification request; and (6) the 

name of a contact person at the seller’s 

company, including a facsimile and a 

telephone number. Section 315.5(b) of 

the proposed Rule incorporates these 

requirements verbatim from the Act. 

(c) Verification Events 

The Act sets forth three circumstances 

under which a seller can consider a 

prescription verified and proceed to sell 

contact lenses to its customer. Under the 

Act, a prescription is verified if: (1) The 

prescriber has confirmed the 

prescription is accurate by direct 

communication with the seller; (2) the 

prescriber has informed the seller that 

the prescription is inaccurate and 

provides the accurate prescription; or 

(3) the prescriber fails to communicate 

with the seller within eight (8) business 

hours (or a similar time period defined 

by the Commission) after receiving a 

proper verification request from the 

seller. 

Section 315.5(c) sets forth these 

circumstances, generally repeating the 

language of the Act. This provision 

clarifies, however, that prescribers must 

use a method of direct communication 

(i.e., telephone, facsimile, or e-mail) in 

conveying their response to the seller’s 

verification request. The method of 

direct communication used by the 

prescriber to respond need not be the 

same method of direct communication 

that the seller used to send a verification 

request. For example, an eye care 

practitioner may respond by telephone 

to a seller’s fax seeking verification. The 

proposed Rule also does not include any 

time period for responding to a 

verification request other than the eight 

business hours mentioned in the Act. 

(d) Invalid Prescription 

The Act articulates the obligations of 

the parties if a seller submits a 

prescription for verification that the 

prescriber determines is invalid. The 

Act mandates that the prescriber must 

specify for the seller the basis for 

concluding that any prescription is 

invalid or inaccurate, and, if the 

prescription is inaccurate, the prescriber 

must provide the correct information to 

the seller. The Act precludes a seller 

from filling a contact lens prescription 

that the prescriber has reported is 

inaccurate, expired, or otherwise 

invalid, except that a seller may fill an 

inaccurate prescription that the 

prescriber has corrected. Section 

315.5(d) of the proposed Rule follows 

the procedures set forth in the Act for 

addressing invalid prescriptions. 

(e) No Alteration of Prescription 

The Act prohibits a seller from 

altering a contact lens prescription of its 

customer. The purpose of this 

requirement apparently is to make 

certain that consumers receive the 

contact lenses specified in their 

prescription. The Act, however, 

contains an exception to address socalled ‘‘private label’’ lenses. Some 

manufacturers make identical contact 

lenses that are sold under multiple 

labels, including the private labels of 

particular providers. Prescribers may be 

able to restrict consumer choice by 

writing prescriptions that are limited to 

specified private label contact lenses, 

even though these lenses are identical to 

other lenses made by the same 

manufacturer and sold by other sellers. 

To address such a restriction, the Act 

allows sellers to fill a prescription with 

identical lenses manufactured by the 

same company even though the lenses 

are being sold under a different label 

than that specified on the prescription. 

Section 315.5(e) follows the Act in 

barring sellers from altering 

prescriptions and in allowing them to 

substitute identical contact lenses for a 

private label that a prescriber has 

specified on a prescription. 

(f) Recordkeeping Requirement 

The Act requires sellers to maintain 

records of all direct communications 

relating to prescription verification. 

Section 315.5(f) proposes to require that 

sellers maintain records of such 

communications, as well as any 

prescriptions they receive from patients 

or prescribers, for a period of at least 

three years, and to have those records 

available for inspection by the Federal 

Trade Commission. The purpose of 

these recordkeeping requirements is to 

allow the Commission to investigate 

whether there has been a rule violation 

and to seek civil penalties for any such 

violations. Given that the statute of 

limitations for obtaining civil penalties 

for rule violations under the FTC Act is 

three years,10 a three-year document 

retention requirement would assist the 

Commission in investigating and 

challenging rule violations. 

Nevertheless, the FTC is particularly 

interested in receiving comments 

describing and documenting the costs 

and benefits of maintaining such 

records for three years.

Section 315.5(f)(1) requires that 

sellers keep copies of prescriptions or 

fax copies of prescriptions they receive 

directly from a patient or a prescriber. 

The purpose of this requirement is to 

Federal Register / Vol. 69, No. 23 / Wednesday, February 4, 2004 / Proposed Rules 5443

11Because the proposed amendments are clerical, 

not substantive, in nature, they are exempt from the 

rulemaking requirements that would apply to any 

substantive amendments to the Ophthalmic Practice 

Rules. See 18 U.S.C. 57(d)(1)(B). Nonetheless, in an 

exercise of its discretion, the Commission seeks 

comment on the proposed amendments in 

conjunction with the comments it seeks on the 

proposed Contact Lens Rule.

document that it was permissible for the 

seller to sell contact lenses to the 

customer under section 7603(a)(1) of the 

Act.

Section 315.5(f)(2), consistent with 

section 7603(b) of the Act, also 

mandates that sellers must maintain 

documentation of verification requests. 

The documents that the proposed rules 

would require sellers to preserve vary 

based on the means of direct 

communication the seller employed to 

seek verification. If the seller 

communicates through facsimile or email, it must maintain a copy of the 

verification request and a confirmation 

of the completed communication of that 

request, including the date and time the 

communication was completed. On the 

other hand, if the seller communicates 

through telephone, the seller must 

maintain a telephone log: (1) Describing 

the information that the seller provided 

to the prescriber (e.g., noting that the 

seller read the required prescription 

information to the prescriber); (2) 

recording the date and time the 

telephone call was completed; and (3) 

indicating how the call was completed 

(e.g., by speaking with someone directly 

(and if so whom) or by leaving a 

message). In addition, for 

communications by telephone, the seller 

must retain copies of its telephone bills. 

Section 315.5(f)(3) further mandates 

that the seller must maintain copies of 

all prescription verification responses 

from prescribers. Again, the specific 

documents to be maintained differ 

based on the method of direct 

communication that the prescriber used 

to contact the seller. If the response to 

a verification request occurs via 

facsimile or e-mail, the seller must 

preserve a copy of the communication 

and a record of the time and date it was 

received. If the response to a verification 

request is communicated via telephone, 

then the seller must maintain a 

telephone log describing the 

information communicated and the date 

and time that it was received. 

Section 315.6 Expiration of Contact 

Lens Prescriptions 

The Act provides that if the expiration 

date for a contact lens prescription 

under state law is one year or more after 

its issue date, then the prescription shall 

expire on the date specified by State 

law. The Act also states that if the 

expiration date for a contact lens 

prescription under State law is less than 

one year after its issue date, or the State 

law does not specify an expiration date, 

then the prescription shall expire not 

less than one year after its issue date. 

Notwithstanding these expiration 

standards, the Act further provides that 

a prescriber may specify a different 

expiration date based on his or her 

medical judgment with respect to the 

ocular health of the patient. The 

purpose of establishing a minimum 

expiration date as a matter of Federal 

law is to prevent prescribers from 

selecting a short expiration date for a 

prescription that unduly limits the 

ability of consumers to purchase contact 

lenses from other sellers, unless 

legitimate medical reasons justify 

setting such an expiration date. 

Section 315.6(a) of the proposed Rule 

closely tracks the expiration date 

requirements set forth in the Act, as 

described above. Section 315.6(b) sets 

forth the procedures that prescribers 

must follow if they determine that 

legitimate medical reasons warrant an 

expiration date of less than one year. 

Specifically, prescribers must document 

these medical reasons in the patient’s 

medical record with sufficient detail to 

allow a qualified medical professional 

to determine the reasonableness of the 

shorter expiration date. As with the 

documents that sellers must maintain 

pursuant to section 315.5(f) of the 

proposed Rule, section 315.6(b) requires 

that prescribers maintain these medical 

records for at least three years and that 

they must be available for inspection by 

the Federal Trade Commission. 

Section 315.7 Content of 

Advertisements and Other 

Representations 

The Act provides that any person that 

engages in the manufacture, processing, 

assembly, sale, offering for sale, or 

distribution of contact lenses may not 

represent, by advertisement, sales 

presentation, or otherwise, that contact 

lenses may be obtained without a 

prescription. Section 315.7 incorporates 

this provision verbatim from the Act. 

Section 315.8 Prohibition of Certain 

Waivers 

The Act provides that a prescriber 

may not place on the prescription, or 

require the patient to sign, or deliver to 

the patient, a form or notice waiving or 

disclaiming the liability or 

responsibility of the prescriber for the 

accuracy of the eye examination. The 

Act further provides that this provision 

does not impose liability on a prescriber 

for the ophthalmic goods and services 

dispensed by another seller pursuant to 

the prescriber’s correctly verified 

prescription. Section 315.8 incorporates 

these provisions verbatim from the Act. 

Section 315.9 Enforcement 

The Act provides that any violation of 

the Act or rules implementing the Act 

shall be treated as a violation of a rule 

under section 18 of the Federal Trade 

Commission Act, 15 U.S.C. 57a, 

regarding unfair or deceptive acts or 

practices. The Act further provides that 

the Commission will enforce its 

implementing rules in the same manner, 

by the same means, and with the same 

jurisdiction, powers, and duties as are 

available to it pursuant to the Federal 

Trade Commission Act, 15 U.S.C. 41 et 

seq. Section 315.9 expressly 

incorporates these provisions from the 

Act. 

Section 315.10 Severability 

Section 315.10 states that the 

provisions of the Contact Lens Rule are 

separate and severable from one 

another. If any provision is stayed or 

determined to be invalid, it thus is the 

Commission’s intention that the 

remaining provisions will continue in 

effect. 

III. Overview of the Proposed Clerical 

Amendments to the Ophthalmic 

Practice Rules (16 CFR Part 456) 

The Commission enforces the 

Ophthalmic Practice Rules, 16 CFR part 

456, which primarily address acts and 

practices related to eyeglasses, not 

contact lenses. To clarify the 

relationship between the Ophthalmic 

Practice Rules and the proposed Contact 

Lens Rule, the Commission hereby 

proposes two clerical amendments to 

the Ophthalmic Practice Rules. The first 

amendment is to change the title of the 

Ophthalmic Practices Rules to 

‘‘Ophthalmic Practice Rules (Eyeglass 

Rule).’’ The second amendment is to 

add to the Ophthalmic Practice Rules a 

cross-reference to the Contact Lens Rule. 

A similar cross-reference to the 

Ophthalmic Practice Rules is included 

in section 315.1 of the proposed Contact 

Lens Rule. The Commission believes 

modifying the title of the Ophthalmic 

Practices Rules to include a reference to 

eyeglasses and including crossreferences in both set of rules will help 

direct businesses and consumers to 

applicable regulatory provisions.11

IV. Invitation to Comment 

Comments from members of the 

public are invited, and may be filed 

with the Commission in either paper or 

electronic form. The Commission will 

give consideration to any written 

comments concerning the proposed 

5444 Federal Register / Vol. 69, No. 23 / Wednesday, February 4, 2004 / Proposed Rules 

12Commission Rule 4.2(d), 16 CFR 4.2(d). The 

comment must also be accompanied by an explicit 

request for confidential treatment, including the 

factual and legal basis for the request, and must 

identify the specific portions of the comment to be 

withheld from the public record. The request will 

be granted or denied by the Commission’s General 

Counsel, consistent with applicable law and the 

public interest. See Commission Rule 4.9(c), 16 CFR 

4.9(c).

13See proposed Rule sections 315.3(a), 

315.6(b)(1); see also 15 U.S.C. 7601(a), 7604(b)(1).

14See proposed Rule section 315.5(f); see also 15 

U.S.C. 7603(b).

15The staff estimates that prescribers will not 

spend any additional time complying with the 

recordkeeping requirement that they record the 

medical reasons for setting a prescription expiration 

date shorter than one year. This is because 

instances of shorter expiration dates will occur 

relatively infrequently and the required medical 

information is likely to be recorded in the ordinary 

course of business in any event.

16The Bureau of Labor Statistics reports an 

average wage for salaried optometrists of $42.00 per 

hour.

17This estimate overstates the actual burden, in 

fact, because prescribers in more than two-thirds of 

the States already provide prescriptions to at least 

some of their patients as required by State Law.

18Again, this estimate overstates that actual 

burden, because some mail order and Internet-based 

contact lens sellers already maintain records 

relating to contact lens prescriptions and 

verification.

Contact Lens Rule and the clerical 

amendments to the Ophthalmic Practice 

Rules submitted on or before April 5, 

2004. 

A public comment filed in paper form 

should be mailed or delivered to the 

following address: Federal Trade 

Commission/Office of the Secretary, 

Room 159–H, (Annex A) 600 

Pennsylvania Avenue, NW., 

Washington, DC 20580. If the comment 

contains any material for which 

confidential treatment is requested, it 

must be filed in paper (rather than 

electronic) form, and the first page of 

the document must be clearly labeled 

‘‘Confidential.’’ 12

A public comment that does not 

contain any material for which 

confidential treatment is requested may 

instead be filed in electronic form (in 

ASCII format, WordPerfect, or Microsoft 

Word), as part of or as an attachment to 

an e-mail message sent to the following 

e-mail box: contactlensrule@ftc.gov.

Regardless of the form in which they 

are filed, all timely comments will be 

considered by the Commission, and will 

be available (with confidential material 

redacted) for public inspection and 

copying on the Commission Web site at 

http://www.ftc.gov and at its principal 

office. As a matter of discretion, the 

Commission makes every effort to 

remove home contact information for 

individuals from the public comments it 

receives, before placing those comments 

on the FTC Web site. 

V. Communications by Outside Parties 

to Commissioners or Their Advisors 

Written communications and 

summaries or transcripts of oral 

communications respecting the merits 

of this proceeding from any outside 

party to any Commissioner or 

Commissioner’s advisor will be placed 

on the public record. See 16 CFR 

1.26(b)(5). 

VI. Paperwork Reduction Act 

The Commission has submitted this 

proposed Rule and a Supporting 

Statement for Information Collection 

Provisions to the Office of Management 

and Budget (‘‘OMB’’) for review under 

the Paperwork Reduction Act of 1995 

(‘‘PRA’’), 44 U.S.C. 3501–3517. As 

required by the Fairness to Contact Lens 

Consumers Act, the proposed Rule 

imposes certain disclosure and 

recordkeeping requirements on contact 

lens prescribers and sellers. 

Specifically, the Rule requires 

prescribers to provide a copy of a 

patient’s contact lens prescription to the 

patient or an authorized third party 

upon completion of a contact lens 

fitting, and further requires prescribers 

to document in their patients’ records 

the medical reasons for setting a contact 

lens prescription expiration date of less 

than one year.13 In addition, the Rule 

requires contact lens sellers to maintain 

records for three years of all direct 

communications involved in obtaining 

verification of a contact lens 

prescription, as well as prescriptions, or 

copies thereof, which they receive 

directly from customers or prescribers.14

The Commission staff estimates the 

paperwork burden of the Act and 

proposed Rule, based on its knowledge 

of the eye care industry. The staff 

believes there will be some burden on 

individual prescribers to provide 

contact lens prescriptions, although it 

involves merely writing a few pieces of 

information onto a slip of paper and 

handing it to the patient, or perhaps 

mailing or faxing it to a third party. The 

burden of documenting the medical 

reasons for setting a prescription 

expiration date shorter than one year 

will be minimal, because such 

expiration dates presumably will be set 

in a relatively limited number of cases, 

and because such records are likely kept 

in the ordinary course of business in 

any event. In addition, there will be 

some recordkeeping burden on contact 

lens sellers—including retaining 

prescriptions or records of ‘‘direct 

communications’’—pertaining to each 

sale of contact lenses to consumers who 

received their original prescription from 

a third party prescriber. 

Overall, the Commission staff has 

estimated that the average annual 

burden during the three-year period for 

which OMB clearance is sought will be 

900,000 burden hours. The estimated 

annual labor cost associated with these 

paperwork burdens is $28.2 million. 

Specifically, the staff estimates that 

prescribers will spend an average of one 

(1) minute providing each prescription 

to a patient or authorized third party. 

Based on its knowledge of the industry, 

the staff estimates that there are 36 

million contact lens wearers in the 

United States who visit their eye care 

practitioner annually, and thus 

prescribers will spend 600,000 hours 

complying with the disclosure 

requirement [(36 million × 1 minute) / 

60 minutes = 600,000].15 At an average 

wage for prescribers of $42.00 per 

hour,16 complying with this 

requirement imposes an estimated $25.2 

million labor cost burden on prescribers 

[$42.00 × 600,000 hours = $25.2 

million].17 In addition, the staff 

estimates that contact lens sellers will 

spend an average of five (5) minutes per 

sale of contact lenses complying with 

the recordkeeping requirements. Based 

on its knowledge of the industry, the 

staff estimates that approximately 10% 

of contact lens sales (i.e., sales by mail 

order and Internet-based sellers) will be 

subject to the recordkeeping 

requirements, 3.6 million consumers’

prescriptions or verifications will need 

to be retained, for a total of 300,000 

hours spent on recordkeeping [(3.6 

million × 5 minutes) / 60 minutes = 

300,000 hours]. At an average wage for 

clerical personnel of $10.00 per hour, 

complying with this requirement 

imposes an estimated $3 million labor 

cost burden on contact lens sellers 

[$10.00 × 300,000 hours = $3 million].18

The Commission invites comments 

that will enable it to: (1) Evaluate 

whether the proposed collections of 

information are necessary for the proper 

performance of the functions of the 

Commission, including whether the 

information will have practical utility; 

(2) evaluate the accuracy of the 

Commission’s estimate of the burden of 

the proposed collections of information, 

including the validity of the 

methodology and assumptions used; (3) 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) minimize the burden of the 

collections of information on those who 

must comply, including through the use 

of appropriate automated, electronic, 

mechanical, or other technological 

techniques or other forms of information 

technology. 

Federal Register / Vol. 69, No. 23 / Wednesday, February 4, 2004 / Proposed Rules 5445

19 15 U.S.C. 7601–7610.

20 15 U.S.C. 7607.

21See 12 CFR 121.201 (Small Business 

Administration’s Table of Small Business Size 

Standards).

22 15 U.S.C. 7601.

23 15 U.S.C. 7604(b).

24 15 U.S.C. 7603(b).

25Labeling regulations of the Food and Drug 

Administration effectively require that contact 

lenses are sold only pursuant to a prescription. 

Certain devices, such as contact lenses, when sold 

without a prescription and without adequate 

directions for use on the label, are ‘‘misbranded’’ in 

violation of the Food, Drug & Cosmetics Act. See

21 U.S.C. 352(f); 21 CFR 801.109(a)(2).

26See 16 CFR 456.2(a).

VII. Regulatory Flexibility Act 

The Regulatory Flexibility Act 

(‘‘RFA’’), 5 U.S.C. 601–612, requires an 

agency to provide an Initial Regulatory 

Flexibility Analysis (‘‘IRFA’’) with a 

proposed rule and a Final Regulatory 

Flexibility Analysis (‘‘FRFA’’) with the 

final rule, if any, unless the agency 

certifies that the rule will not have a 

significant economic impact on a 

substantial number of small entities. See

5 U.S.C. 603–605. 

The FTC does not expect that the 

proposed Contact Lens Rule will have a 

significant economic impact on a 

substantial number of small entities. 

The Fairness to Contact Lens Consumers 

Act 19 expressly mandates most, if not 

all, of the proposed Rule’s requirements, 

and thus accounts for most, if not all, of 

the economic impact of the proposed 

Rule. In any event, the burdens most 

likely to be imposed on small entities 

(which are likely to be contact lens 

prescribers)—such as providing contact 

lens prescriptions to patients or their 

agents, recording the medical reasons 

for setting prescription expiration dates 

of less than one year, and verifying 

prescription information—are likely to 

be relatively small. The more significant 

burdens imposed by the Rule likely will 

fall primarily on larger sellers of contact 

lenses, which are more likely to be 

seeking verification of prescriptions and 

thus triggering the Act’s more 

significant recordkeeping requirements.

This document serves as notice to the 

Small Business Administration of the 

agency’s certification of no effect. 

Nonetheless, the Commission has 

determined that it is appropriate to 

publish an IRFA in order to inquire into 

the impact of the proposed Rule on 

small entities. Therefore, the 

Commission has prepared the following 

analysis. 

A. Description of the Reasons That 

Action by the Agency Is Being 

Considered 

The Fairness to Contact Lens 

Consumers Act directs the Commission 

to prescribe rules implementing the Act 

not later than 180 days after the Act 

takes effect on February 4, 2004.20

Accordingly, the Commission has 

prepared the proposed Contact Lens 

Rule announced in this document.

B. Succinct Statement of the Objectives 

of, and Legal Basis for, the Proposed 

Rules 

As set forth above, the objective of the 

proposed Contact Lens Rule is to 

implement the requirements of the 

Fairness to Contact Lens Consumers 

Act. The legal basis for the proposed 

Rule is the Act itself, 15 U.S.C. 7601–

7610. 

C. Description of and, Where Feasible, 

Estimate of the Number of Small 

Entities to Which the Proposed Rule 

Will Apply 

In general, the proposed Rule applies 

to both ‘‘prescribers’’ and ‘‘sellers’’ of 

contact lenses. The FTC staff believes 

that many prescribers will fall into the 

category of small entities (e.g., Offices of 

Optometrists less than $6 million in 

size), but that, for the most part, sellers 

subject to the Rule’s recordkeeping 

requirements likely will be larger 

businesses (e.g., Mail Order Houses or 

Electronic Shopping entities greater 

than $21 million in size).21 Determining 

a precise estimate of the number of 

small entities covered by the Rule’s 

disclosure and recordkeeping 

requirements is not readily feasible. The 

Commission invites comment and 

information on this issue.

D. Projected Reporting, Recordkeeping 

and Other Compliance Requirements, 

Including an Estimate of the Classes of 

Small Entities That Will Be Subject to 

the Requirement and the Type of 

Professional Skills Necessary for 

Preparation of the Report or Record 

As mandated by the Act, the proposed 

Rule imposes disclosure and 

recordkeeping requirements, within the 

meaning of the Paperwork Reduction 

Act, on contact lens prescribers and 

sellers. With respect to disclosure, the 

Rule requires prescribers to provide 

patients with a copy of their contact 

lens prescription upon completion of a 

contact lens fitting, and to provide such 

prescriptions to third parties authorized 

to act on behalf of patients.22

The Rule also implements several 

recordkeeping requirements. First, in 

cases in which a prescriber sets a 

contact lens prescription expiration date 

shorter than one year, the prescriber 

must document in the patient’s record 

the medical reasons justifying the 

shorter expiration date.23 Section 

315.5(f) of the proposed Rule requires 

that such records be kept for three (3) 

years. Second, the Act requires sellers to 

maintain records of all direct 

communications relating to prescription 

verification.24 Accordingly, section 

315.5(f) of the proposed Rule requires 

that sellers maintain records of such 

communications, as well as 

prescriptions they receive directly from 

the patient or prescriber, for a period of 

at least three years. The specific records 

a seller must retain vary depending on 

the manner of communication. If the 

communication occurs through 

facsimile or email, the seller must retain 

a copy of the verification request, a 

confirmation of the completed 

communication of that request 

(including the date and time the 

communication was completed), and 

any response from the provider. If the 

communication occurs through 

telephone, the required record consists 

of a telephone log describing the 

information provided, the date and time 

of the telephone call, and how the call 

was completed (e.g., by speaking with 

someone directly or leaving a message). 

For telephone communications the 

seller also must retain its telephone bill. 

The proposed Rule requires that the 

records be available for inspection by 

the Commission, but does not otherwise 

require production of the records.

The Commission is seeking clearance 

from the Office of Management and 

Budget (‘‘OMB’’) for these requirements 

and the Commission’s Supporting 

Statement submitted as part of that 

process will be made available on the 

public record of this rulemaking. As set 

forth in section VI above, the 

Commission staff has estimated that the 

proposed Rule’s disclosure and 

recordkeeping requirements referenced 

above will require an average annual 

burden of 600,000 hours on prescribers, 

for a total annual labor cost of $25.2 

million, and an average annual burden 

on sellers of 300,000 hours on sellers, 

for a total annual labor cost of $3 

million. 

E. Other Duplicative, Overlapping, or 

Conflicting Federal Rules 

The FTC believes there are no other 

Federal statutes, rules, or policies that 

would conflict with the proposed Rule. 

In fact, the proposed Rule reinforces the 

existing Federal requirement that 

contact lenses be sold only pursuant to 

a prescription,25 and complements the 

Commission’s existing Ophthalmic 

Practices Rule’s requirement that 

prescribers provide patients with a copy 

of their eyeglass prescription upon the 

completion of an eye examination.26

5446 Federal Register / Vol. 69, No. 23 / Wednesday, February 4, 2004 / Proposed Rules 

27The Act becomes effective 60 days after the 

date of its enactment, which was December 6, 2003. 

See Pub. L. 108–164, section 12 (set out as note 

under 15 U.S.C. 7601). 28 15 U.S.C. 7607.

F. Description of Any Significant 

Alternatives to the Proposed Rule That 

Would Accomplish the Stated 

Objectives of Applicable Statutes and 

That Minimize Any Significant 

Economic Impact of the Proposed Rule 

on Small Entities, Including Alternatives 

Considered, Such as: (1) Establishment 

of Differing Compliance or Reporting 

Requirements or Timetables That Take 

Into Account the Resources Available to 

Small Entities; (2) Clarification, 

Consolidation, or Simplification of 

Compliance and Reporting 

Requirements Under the Rule for Such 

Small Entities; (4) Any Exemption From 

Coverage of the Rule, or Any Part 

Thereof, for Such Small Entities 

The proposed Rule’s disclosure and 

recordkeeping requirements are 

designed to impose the minimum 

burden on all affected members of the 

industry, regardless of size. The Act 

itself does not allow the Commission 

any latitude to treat small businesses 

differently, such as by exempting a 

particular category of firm or setting 

forth a lesser standard of compliance for 

any category of firm. However, the 

burdens imposed by the Act and 

proposed Rule on small businesses are 

likely to be relatively limited. The small 

businesses affected by the Rule are 

likely to consist primarily of contact 

lens prescribers in solo or small 

practices. Their burdens under the Rule 

primarily would entail providing 

contact lens prescriptions to patients or 

their agents, documenting in 

exceptional cases the medical reasons 

for setting a contact lens prescription 

date of less than one year, and verifying 

prescriptions for some of their patients 

who seek to purchase their contact 

lenses from another seller. Thus, the 

Commission does not believe that the 

proposed Rule will impose a significant 

economic impact on a substantial 

number of small businesses.

Nonetheless, the Commission 

specifically requests comment on the 

question whether the proposed Rule 

imposes a significant impact upon a 

substantial number of small entities, 

and what modifications to the Rule the 

Commission could make to minimize 

the burden on small entities. Moreover, 

the Commission requests comment on 

the general question whether new 

technology or changes in technology can 

be used to reduce the burdens mandated 

by the Act. 

Questions for Comment To Assist 

Regulatory Flexibility Analysis 

1. Please provide information or 

comment on the number and type of 

small entities affected by the proposed 

Rule. Include in your comments the 

number of small entities that will be 

required to comply with the Rule’s 

disclosure and recordkeeping 

requirements. 

2. Please provide comment on any or 

all of the provisions in the proposed 

Rule with regard to (a) the impact of the 

provision(s) (including benefits and 

costs), if any, and (b) what alternatives, 

if any, the Commission should consider, 

as well as the costs and benefits of those 

alternatives, paying specific attention to 

the effect of the proposed Rule on small 

entities in light of the above analysis. In 

particular, please provide the above 

information with regard to the 

disclosure and recordkeeping provisions 

of the proposed Rule set forth in 

sections 315.3(a), 315.5(f), and 315.6(b), 

and describe any ways in which the 

proposed Rule could be modified to 

reduce any costs or burdens for small 

entities consistent with the Act’s 

mandated requirements. Costs to 

‘‘implement and comply’’ with the 

proposed Rule include expenditures of 

time and money for: any employee 

training; attorney, computer 

programmer or other professional time; 

preparing relevant materials (i.e., 

prescriptions for release), and 

recordkeeping. 

3. Please describe ways in which the 

Rule could be modified to reduce any 

costs or burdens on small entities 

consistent with the Act’s mandated 

requirements, including whether and 

how technological developments could 

reduce the costs of implementing and 

complying with the proposed Rule for 

small entities. 

4. Please provide any information 

quantifying the economic benefits of the 

proposed Rule on the entities covered 

by the Act, including small entities. 

5. Please identify any relevant 

Federal, State, or local rules that may 

duplicate, overlap or conflict with the 

proposed Rule. In addition, please 

identify any industry rules or policies 

that require covered entities to engage in 

business practices that would already 

comply with the requirements of the 

proposed Rule. 

VIII. Effective Date 

The Act takes effect on February 4, 

2004,27 and thus prescribers and sellers 

of contact lenses, and other parties 

covered by the Act, have a legal 

obligation to comply with the Act as of 

that date. The Act directs the 

Commission to prescribe rules that will 

become effective no later than 180 days 

after the effective date of the Act.28 The 

FTC intends to issue final rules with an 

effective date within the time specified 

in the Act. The Commission will 

announce a specific effective date for 

the Contact Lens Rule when it issues its 

final rule.

IX. Questions on the Proposed Contact 

Lens Rule and the Proposed Clerical 

Amendments to the Ophthalmic 

Practice Rules 

The Commission is seeking comment 

on various aspects of the proposed 

Contact Lens Rule, and is particularly 

interested in receiving comment on the 

questions that follow. These questions 

are designed to assist the public and 

should not be construed as a limitation 

on the issues on which public comment 

may be submitted. Responses to these 

questions should cite the numbers and 

subsection of the questions being 

answered. For all comments submitted, 

please submit any relevant data, 

statistics, or any other evidence, upon 

which those comments are based. 

General Questions 

1. Please provide comment on any or 

all of the provisions in the proposed 

Contact Lens Rule and the proposed 

clerical amendments to the Ophthalmic 

Practice Rules. For each provision 

commented on please describe (a) the 

impact of the provision(s) (including 

benefits and costs), if any, and (b) what 

alternatives, if any, the Commission 

should consider, as well as the costs and 

benefits of those alternatives. 

2. Please provide comment on the 

effect of the proposed Contact Lens Rule 

on the costs, profitability, and 

competitiveness of, and employment in, 

small entities. 

Questions Pertaining to the Proposed 

Contact Lens Rule 

Definitions 

3. Section 315.2 defines ‘‘business 

hour.’’ (a) Is this definition sufficiently 

clear?

(b) What is the impact, including 

costs and benefits, of defining the term 

in this way? (c) Should the definition 

include provisions addressing (i) 

prescriber vacation days, (ii) State or 

local holidays, (iii) weekend days, or 

(iv) other exceptions to normal business 

hours? 

4. Section 315.2 defines ‘‘contact lens 

fitting.’’ (a) Is this definition sufficiently 

clear? (b) What is the impact, including 

costs and benefits, of defining the term 

in this way? (c) Should the term 

‘‘medically necessary follow-up 

Federal Register / Vol. 69, No. 23 / Wednesday, February 4, 2004 / Proposed Rules 5447

examinations’’ be defined, and, if so, 

how? 

5. Section 315.2 defines ‘‘contact lens 

prescription.’’ (a) Is this definition 

sufficiently clear? (b) What is the 

impact, including costs and benefits, of 

defining the term in this way? (c) 

Should the definition include the 

prescriber’s e-mail address, if any? (d) 

Should the definition include anything 

else? 

6. Should the Commission define 

‘‘contact lenses’’ for purposes of the Act, 

and, if so, should such definition 

specifically exclude non-corrective or 

‘‘cosmetic’’ contact lenses, because 

consumers do not need a prescription to 

purchase them? 

7. Section 315.2 defines ‘‘direct 

communication.’’ (a) Is this definition 

sufficiently clear? (b) What is the 

impact, including costs and benefits, of 

defining the term in this way? (c) Is it 

appropriate to include messages left on 

telephone answering machines in this 

definition? (d) Should the definition 

expressly require, for communication by 

facsimile or e-mail, the receipt of a 

confirmation that the communication 

was successful? (e) Should the 

definition include any other means of 

direct communication? 

8. Section 315.2 defines ‘‘issue date.’’

(a) Is this definition sufficiently clear? 

(b) Is this term currently defined under 

State laws relating to contact lens 

prescriptions? (c) What is the impact, 

including costs and benefits, of defining 

the term in this way? 

9. Section 315.2 defines ‘‘ophthalmic 

goods.’’ (a) Is this definition sufficiently 

clear? (b) Is there any reason that 

ophthalmic goods should be defined 

differently for purposes of the proposed 

Contact Lens Rule and the Ophthalmic 

Practice Rules? (c) What is the impact, 

including costs and benefits, of defining 

the term in this way? 

10. Section 315.2 defines ‘‘ophthalmic 

services.’’ (a) Is this definition 

sufficiently clear? (b) Is there any reason 

that ophthalmic services should be 

defined differently for purposes of the 

proposed Contact Lens Rule and the 

Ophthalmic Practice Rules? (c) What is 

the impact, including costs and benefits, 

of defining the term in this way? 

11. Section 315.2 defines 

‘‘prescriber.’’ (a) Is this definition 

sufficiently clear? (b) What is the 

impact, including costs and benefits, of 

defining the term in this way? 

12. Section 315.2 defines ‘‘private 

label contact lenses.’’ (a) Is this 

definition sufficiently clear? (b) What is 

the impact, including costs and benefits, 

of defining the term in this way? 

Availability of Contact Lens 

Prescriptions to Patients 

13. Section 315.3(a) requires 

prescribers to release and verify contact 

lens prescriptions to their patients and 

to any person designated to act on 

behalf of the patient. (a) Is this provision 

sufficiently clear? (b) Is it clear the 

means by which a prescriber shall 

provide or verify a contact lens 

prescription as directed by a third party 

authorized to act on behalf of the 

patient? 

14. Section 315.3(b) prohibits 

prescribers from imposing certain 

requirements or conditions on patients 

prior to releasing or verifying contact 

lens prescriptions, including charging 

them any fee in addition to the fee for 

an eye examination, fitting, and 

evaluation to receive a prescription or to 

have a prescription verified. (a) Do 

prescribers itemize charges and fees in 

a manner that distinguishes the amount 

the patient is paying for an eye 

examination, fitting, and evaluation 

from the amount he or she is paying for 

other goods and services? (b) Are there 

additional requirements or conditions 

that should be prohibited to facilitate 

the release and verification of contact 

lens prescriptions? (c) What would be 

the impact, including costs and benefits, 

of such additional prohibitions? 

Limits on Requiring Immediate Payment 

15. Section 315.4 limits the 

circumstances under which a prescriber 

may require immediate payment for fees 

for an eye examination, fitting, and 

evaluation prior to releasing a contact 

lens prescription. Is this provision 

sufficiently clear? 

Prescriber Verification 

16. Section 315.5(a) sets forth the 

circumstances under which contact lens 

sellers may sell contact lenses to a 

patient. (a) Is this provision sufficiently 

clear, and, if not, what should be 

clarified? (b) Should the Commission 

specify, for purposes of paragraph (a)(1), 

that either the original or a copy of a 

prescription will suffice? (c) Are there 

additional requirements the 

Commission should consider imposing, 

and what would be the impact, 

including costs and benefits, of such 

additional requirements? 

17. Section 315.5(b) sets forth the 

information a contact lens seller must 

provide to a prescriber when the seller 

seeks verification of a contact lens 

prescription. (a) Is this provision 

sufficiently clear? (b) What is the 

impact, including costs and benefits, of 

this provision? (c) Is there any 

additional information a prescriber 

needs in order to verify a contact lens 

prescription? (d) If prescribers receive 

the name of a contact person at the 

seller, as well as his or her telephone 

number and fax number, is this 

sufficient to enable a prescriber to 

respond to a verification request within 

eight (8) business hours as defined in 

section 315.5(c)? 

18. Section 315.5(c) defines the 

circumstances under which a contact 

lens prescription is deemed verified. (a) 

Is this provision sufficiently clear? (b) 

What is the impact, including costs and 

benefits, of this provision? (c) Is there a 

different time period that is similar to 

eight business hours, as set forth in 

section 315.5(c)(3), that would give 

prescribers an adequate period of time 

during normal office hours to act upon 

a prescription verification request and 

still allow sellers to fill customer orders 

expeditiously? (d) What would be the 

impact, including costs and benefits, of 

such other time period? (e) Does the 

Health Insurance Portability and 

Accountability Act of 1996 (‘‘HIPAA’’) 

limit or otherwise affect prescribers’

ability to respond to a verification 

request pursuant to section 315.5(c) 

and/or section 315.5(d)? 

19. Section 315.5(d) prohibits a 

contact lens seller from filling a 

prescription if the prescriber provides 

timely notice to the seller that the 

prescription is inaccurate, expired, or 

otherwise invalid, unless the prescriber 

has corrected the inaccuracy. (a) Is this 

provision sufficiently clear? (b) Should 

the Commission specifically define 

inaccurate, invalid, and expired 

prescriptions, and, if so, what should 

those definitions include? (c) What is 

the impact, including the costs and 

benefits, of this provision? 

20. Section 315.5(e) prohibits sellers 

from altering contact lens prescriptions, 

but allows them to substitute identical 

contact lenses from the same 

manufacturer for private label lenses 

specified on a prescription. (a) Is this 

provision sufficiently clear? (b) What is 

the impact, including costs and benefits, 

of this provision? 

21. Section 315.5(f) requires contact 

lens sellers to maintain for three (3) 

years records of prescriptions received, 

direct communications with prescribers 

to verify prescriptions, and responses 

from prescribers to these requests for 

verification. (a) Is this provision 

sufficiently clear? (b) What is the 

impact, including costs and benefits, of 

this provision—particularly with 

respect to the types of documents and 

the length of time they must be 

retained? (c) Are there additional items 

the Commission should require be 

maintained? (d) How can the 

5448 Federal Register / Vol. 69, No. 23 / Wednesday, February 4, 2004 / Proposed Rules 

Commission minimize the burden on 

sellers imposed by the recordkeeping 

requirement? (e) Are there technological 

means available to provide confirmation 

to the sender that an email has been 

received by the intended recipient? 

Expiration of Contact Lens Prescriptions 

22. Section 315.6(a) establishes a 

minimum contact lens prescription 

expiration date of one year, subject to an 

exception based on the medical 

judgment of a prescriber. (a) Is this 

provision sufficiently clear? (b) What is 

the impact, including the costs and 

benefits, of this provision? 

23. Section 315.6(b) sets forth special 

rules for contact lens prescriptions that 

expire in less than one year, including 

a requirement that prescribers document 

the specific reasons for the medical 

judgment on which the shorter 

expiration date is based. (a) Is this 

provision sufficiently clear? (b) What is 

the impact, including the costs and 

benefits, of this provision? (c) In what 

circumstances would there be legitimate 

medical reasons for setting a contact 

lens prescription expiration date of less 

than one year? (d) How can the 

Commission minimize the burden on 

prescribers imposed by the 

documentation requirement and the 

three-year time period for retention? (e) 

For how long do prescribers currently 

retain medical records for their contact 

lens patients? 

Content of Advertisements and Other 

Representations 

24. Section 315.7 prohibits the 

representation that contact lenses may 

be obtained without a prescription. (a) 

Is this provision sufficiently clear? (b) 

What is the impact, including the costs 

and benefits, of this provision? (c) 

Should the Commission clarify that this 

provision applies only to contact lenses 

for which a prescription is required, i.e., 

that it does not apply to non-corrective 

or ‘‘cosmetic’’ contact lenses? 

Prohibition of Certain Waivers 

25. Section 315.8 prohibits prescribers 

from waiving liability or responsibility 

for the accuracy of the eye examination. 

(a) Is this provision sufficiently clear? 

(b) What is the impact, including the 

costs and benefits, of this provision? 

Enforcement 

26. Section 315.9 explains how the 

Commission will treat violations of the 

Contact Lens Rule and defines the scope 

of the agency’s enforcement power and 

jurisdiction. (a) Is this provision 

sufficiently clear? (b) What is the 

impact, including the costs and benefits, 

of this provision? 

Questions on the Proposed Clerical 

Amendments to the Ophthalmic 

Practice Rules 

27. The Commission proposes 

amending the title of 16 CFR Part 456 

to read: Ophthalmic Practice Rules 

(Eyeglass Rule). What is the impact, if 

any, of such an amendment and would 

it effect any substantive change to the 

Rules?

28. The Commission proposed adding 

a new paragraph 456.5 to the 

Ophthalmic Practices Rules to provide a 

cross-reference to the Contact Lens Rule. 

What is the impact, if any, of such an 

amendment and would it effect any 

substantive change to the Rules? 

X. Proposed Contact Lens Rule and 

Clerical Amendments to the 

Ophthalmic Practice Rules (16 CFR 

Part 456)

List of Subjects in 16 CFR Parts 315 and 

456 

Advertising, Medical devices, 

Ophthalmic goods and services, Trade 

practices.

Accordingly, for the reasons stated in 

the preamble, the Federal Trade 

Commission proposes to amend 16 CFR 

chapter I as follows: 

1. Add a new part 315 to subchapter 

C to read as follows:

PART 315—CONTACT LENS RULE

Sec. 

315.1 Scope of regulations in this part. 

315.2 Definitions. 

315.3 Availability of contact lens 

prescriptions to patients. 

315.4 Limits on requiring immediate 

payment. 

315.5 Prescriber verification. 

315.6 Expiration of contact lens 

prescriptions. 

315.7 Content of advertisements and other 

representations. 

315.8 Prohibition of certain waivers. 

315.9 Enforcement. 

315.10 Severability.

Authority: Pub. L. 108–164, secs. 1–12; 15 

U.S.C. 7601–7610.

§ 315.1 Scope of regulations in this part. 

This part, which shall be called the 

‘‘Contact Lens Rule,’’ implements the 

Fairness to Contact Lens Consumers 

Act, codified at 15 U.S.C. 7601–7610, 

which requires that rules be issued to 

address the release and verification of 

contact lens prescriptions. This part 

specifically governs contact lens 

prescriptions and related issues. Part 

456 of Title 16 governs the availability 

of eyeglass prescriptions and related 

issues. 16 CFR part 456 (the Ophthalmic 

Practice Rules (Eyeglass Rule)).

§ 315.2 Definitions. 

Business hour means an hour between 

9 a.m. and 5 p.m., during a weekday 

(Monday through Friday), excluding 

Federal holidays. For purposes of 

§ 315.5(d)(3), ‘‘eight (8) business hours’’

shall be calculated from the first 

business hour that occurs after the seller 

provides the prescription verification 

request to the prescriber, and shall 

conclude after eight (8) business hours 

have elapsed. For verification requests 

received by a prescriber during nonbusiness hours, the calculation of ‘‘eight 

(8) business hours’’ shall begin at 9 a.m. 

on the next weekday that is not a 

Federal holiday. 

Commission means the Federal Trade 

Commission. 

Contact lens fitting means the process 

that begins after an initial eye 

examination for contact lenses and ends 

when a successful fit has been achieved 

or, in the case of a renewal prescription, 

ends when the prescriber determines 

that no change in the existing 

prescription is required, and such term 

may include: 

(1) An examination to determine lens 

specifications; 

(2) Except in the case of a renewal of 

a contact lens prescription, an initial 

evaluation of the fit of the contact lens 

on the eye; and 

(3) Medically necessary follow-up 

examinations. 

Contact lens prescription means a 

prescription, issued in accordance with 

State and Federal law, that contains 

sufficient information for the complete 

and accurate filling of a prescription for 

contact lenses, including the following: 

(1) The name of the patient; 

(2) The date of examination; 

(3) The issue date and expiration date 

of prescription; 

(4) The name, postal address, 

telephone number, and facsimile 

telephone number of prescriber; 

(5) The power, material or 

manufacturer or both of the prescribed 

contact lens; 

(6) The base curve or appropriate 

designation of the prescribed contact 

lens; 

(7) The diameter, when appropriate, 

of the prescribed contact lens; and 

(8) In the case of a private label 

contact lens, the name of the 

manufacturer, trade name of the private 

label brand, and, if applicable, trade 

name of equivalent brand name. 

Direct communication, as used in 

§ 315.5, means completed 

communication by telephone, facsimile, 

or electronic mail. 

Issue date, as used in § 315.6, means 

the date on which the patient receives 

a copy of the prescription.

Federal Register / Vol. 69, No. 23 / Wednesday, February 4, 2004 / Proposed Rules 5449

Ophthalmic goods are contact lenses, 

eyeglasses, or any component of 

eyeglasses. 

Ophthalmic services are the 

measuring, fitting, and adjusting of 

ophthalmic goods subsequent to an eye 

examination. 

Prescriber means, with respect to 

contact lens prescriptions, an 

ophthalmologist, optometrist, or other 

person permitted under State law to 

issue prescriptions for contact lenses in 

compliance with any applicable 

requirements established by the Food 

and Drug Administration. 

Private Label Contact Lenses mean 

contact lenses that are sold under the 

label of a seller where the contact lenses 

are identical to lenses made by the same 

manufacturer but sold under the labels 

of other sellers.

§ 315.3 Availability of Contact Lens 

Prescriptions to Patients 

(a) In general. When a prescriber 

completes a contact lens fitting, the 

prescriber: 

(1) Whether or not requested by the 

patient, shall provide to the patient a 

copy of the contact lens prescription; 

and 

(2) Shall, as directed by any person 

designated to act on behalf of the 

patient, provide or verify the contact 

lens prescription by electronic or other 

means. 

(b) Limitations. A prescriber may not: 

(1) Require the purchase of contact 

lenses from the prescriber or from 

another person as a condition of 

providing a copy of a prescription under 

paragraph (a)(1) or (a)(2) of this section 

or as a condition of verification of a 

prescription under paragraph (a)(2) of 

this section; 

(2) Require payment in addition to, or 

as part of, the fee for an eye 

examination, fitting, and evaluation as a 

condition of providing a copy of a 

prescription under paragraph (a)(1) or 

(a) (2) of this section or as a condition 

of verification of a prescription under 

paragraph (a)(2) of this section; or 

(3) Require the patient to sign a 

waiver or release as a condition of 

releasing or verifying a prescription 

under paragraph (a)(1) or (a)(2) of this 

section.

§ 315.4 Limits on Requiring Immediate 

Payment 

A prescriber may require payment of 

fees for an eye examination, fitting, and 

evaluation before the release of a contact 

lens prescription, but only if the 

prescriber requires immediate payment 

in the case of an examination that 

reveals no requirement for ophthalmic 

goods. For purposes of the preceding 

sentence, presentation of proof of 

insurance coverage for that service shall 

be deemed to be a payment.

§ 315.5 Prescriber Verification 

(a) Prescription requirement. A seller 

may sell contact lenses only in 

accordance with a contact lens 

prescription for the patient that is: 

(1) Presented to the seller by the 

patient or prescriber directly or by 

facsimile; or 

(2) Verified by direct communication. 

(b) Information for verification. When 

seeking verification of a contact lens 

prescription, a seller shall provide the 

prescriber with the following 

information through direct 

communication: 

(1) The patient’s full name and 

address; 

(2) The contact lens power, 

manufacturer, base curve or appropriate 

designation, and diameter when 

appropriate;

(3) The quantity of lenses ordered; 

(4) The date of patient request; 

(5) The date and time of verification 

request; and 

(6) The name of a contact person at 

the seller’s company, including 

facsimile and telephone numbers. 

(c) Verification events. A prescription 

is verified under paragraph (a)(2) of this 

section only if one of the following 

occurs: 

(1) The prescriber confirms the 

prescription is accurate by direct 

communication with the seller; 

(2) The prescriber informs the seller 

through direct communication that the 

prescription is inaccurate and provides 

the accurate prescription; or 

(3) The prescriber fails to 

communicate with the seller within 

eight (8) business hours after receiving 

from the seller the information 

described in paragraph (b) of this 

section. 

(d) Invalid prescription. If a prescriber 

informs a seller before the deadline 

under paragraph (c)(3) of this section 

that the contact lens prescription is 

inaccurate, expired, or otherwise 

invalid, the seller shall not fill the 

prescription. The prescriber shall 

specify the basis for the inaccuracy or 

invalidity of the prescription. If the 

prescription communicated by the seller 

to the prescriber is inaccurate, the 

prescriber shall correct it, and the 

prescription shall then be deemed 

verified under paragraph (c)(2) of this 

section. 

(e) No alteration of prescription. A 

seller may not alter a contact lens 

prescription. Notwithstanding the 

preceding sentence, a seller may 

substitute for private label contact 

lenses specified on a prescription 

identical contact lenses that the same 

company manufactures and sells under 

different labels. 

(f) Recordkeeping requirement. A 

seller shall maintain a record of all 

direct communications referred to in 

paragraph (a) of this section. Such 

record shall consist of the following: 

(1) For prescriptions presented to the 

seller: the prescription itself, or the 

facsimile version thereof, that was 

presented to the seller by the patient or 

prescriber. 

(2) For verification requests by the 

seller: 

(i) If the communication occurs via 

facsimile or e-mail, a copy of the 

verification request, including the 

information provided to the prescriber 

pursuant to paragraph (b) of this section, 

and confirmation of the completed 

transmission thereof, including a record 

of the date and time the request was 

made. 

(ii) If the communication occurs via 

telephone, a telephone log: 

(A) Describing the information 

provided pursuant to paragraph (b) of 

this section; 

(B) Setting forth the date and time the 

request was made; and 

(C) Indicating how the call was 

completed. 

(D) The seller also must retain copies 

of its telephone bills. 

(3) For communications from the 

prescriber, including prescription 

verifications: 

(i) If the communication occurs via 

facsimile or e-mail, a copy of the 

communication and a record of the time 

and date it was received. 

(ii) If the communication occurs via 

telephone, a telephone log describing 

the information communicated and the 

date and time that the information was 

received. 

(4) The records required to be 

maintained under this section shall be 

maintained for a period of not less than 

three years, and these records must be 

available for inspection by the Federal 

Trade Commission, its employees, and 

its representatives.

§ 315.6 Expiration of contact lens 

prescriptions. 

(a) In general. A contact lens 

prescription shall expire: 

(1) On the date specified by the law 

of the State in which the prescription 

was written, if that date is one year or 

more after the issue date of the 

prescription; 

(2) Not less than one year after the 

issue date of the prescription if such 

State law specifies no date or specifies 

a date that is less than one year after the 

issue date of the prescription; or 

5450 Federal Register / Vol. 69, No. 23 / Wednesday, February 4, 2004 / Proposed Rules 

(3) Notwithstanding paragraphs (a)(1) 

and (2) of this section, on the date 

specified by the prescriber, if that date 

is based on the medical judgment of the 

prescriber with respect to the ocular 

health of the patient. 

(b) Special rules for prescriptions of 

less than one year. (1) If a prescription 

expires in less than one year, the 

specific reasons for the medical 

judgment referred to in paragraph (a)(3) 

of this section shall be documented in 

the patient’s medical record with 

sufficient detail to allow for review by 

a qualified professional in the field. 

(2) The documentation described in 

paragraph (b)(1) of this section shall be 

maintained for a period of not less than 

three years, and it must be available for 

inspection by the Federal Trade 

Commission, its employees, or its 

representatives. 

(3) No prescriber shall include an 

expiration date on a prescription that is 

less than the period of time that he or 

she recommends for a reexamination of 

the patient that is medically necessary.

§ 315.7 Content of advertisements and 

other representations. 

Any person that engages in the 

manufacture, processing, assembly, sale, 

offering for sale, or distribution of 

contact lenses may not represent, by 

advertisement, sales presentation, or 

otherwise, that contact lenses may be 

obtained without a prescription.

§ 315.8 Prohibition of certain waivers. 

A prescriber may not place on a 

prescription, or require the patient to 

sign, or deliver to the patient, a form or 

notice waiving or disclaiming the 

liability or responsibility of the 

prescriber for the accuracy of the eye 

examination. The preceding sentence 

does not impose liability on a prescriber 

for the ophthalmic goods and services 

dispensed by another seller pursuant to 

the prescriber’s correctly verified 

prescription.

§ 315.9 Enforcement. 

Any violation of this part shall be 

treated as a violation of a rule under 

section 18 of the Federal Trade 

Commission Act, 15 U.S.C. 57a, 

regarding unfair or deceptive acts or 

practices, and the Commission will 

enforce this part in the same manner, by 

the same means, and with the same 

jurisdiction, powers, and duties as are 

available to it pursuant to the Federal 

Trade Commission Act, 15 U.S.C. 41 et 

seq.

§ 315.10 Severability. 

The provisions of this part are 

separate and severable from one 

another. If any provision is stayed or 

determined to be invalid, it is the 

Commission’s intention that the 

remaining provisions shall continue in 

effect.

PART 456—AMENDED 

2. The authority citation for part 456 

continues to read as follows:

Authority: 15 U.S.C. 57a; 5 U.S.C. 552.

3. Revise the title of part 456 to read 

as follows:

PART 456—OPHTHALMIC PRACTICE 

RULES (EYEGLASS RULE) 

4. Add a new § 456.5 to read as 

follows:

§ 456.5 Rules applicable to prescriptions 

for contact lenses and related issues. 

Rules applicable to prescriptions for 

contact lenses and related issues may be 

found at 16 CFR part 315 (Contact Lens 

Rule).

By direction of the Commission. 

Donald S. Clark, 

Secretary.

[FR Doc. 04–2235 Filed 2–3–04; 8:45 am] 

BILLING CODE 6750–01–P