[Federal Register Volume 69, Number 23 (Wednesday, February 4, 2004)]
[Proposed Rules]
[Pages 5440-5450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2235]



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Part VI





Federal Trade Commission





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16 CFR Parts 315 and 456



Contact Lens Rule; Ophthalmic Practice Rules; Proposed Rule and Final 
Rule

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

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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.

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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: 
[email protected]. 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, [email protected], 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\
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    \1\ 15 U.S.C. 7601-7610 (Pub. L. 108-164).
    \2\ Id. at 7601.
    \3\ Id. at 7601, 7603.
    \4\ Id. at 7609.
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    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\
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    \5\ Id. at 7607.
    \6\ Id. at 7608.
    \7\ Id.
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    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.
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    \8\ 16 CFR part 456.
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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.
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    \9\ See 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)).
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    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

[[Page 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

[[Page 5442]]

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 so-called ``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.
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    \10\ Section 19(d) of the FTC Act, 15 U.S.C. 57b(d).
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    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

[[Page 5443]]

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 e-mail, 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 cross-references in both set of rules will help direct 
businesses and consumers to applicable regulatory provisions.\11\
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    \11\ Because 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.
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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

[[Page 5444]]

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\
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    \12\ Commission 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).
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    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: 
[email protected].
    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\
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    \13\ See proposed Rule sections 315.3(a), 315.6(b)(1); see also 
15 U.S.C. 7601(a), 7604(b)(1).
    \14\ See proposed Rule section 315.5(f); see also 15 U.S.C. 
7603(b).
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    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 x 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 x 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 x 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 x 300,000 hours = $3 
million].\18\
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    \15\ The 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.
    \16\ The Bureau of Labor Statistics reports an average wage for 
salaried optometrists of $42.00 per hour.
    \17\ This 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.
    \18\ Again, 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.
---------------------------------------------------------------------------

    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.

[[Page 5445]]

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.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 7601-7610.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 7607.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \21\ See 12 CFR 121.201 (Small Business Administration's Table 
of Small Business Size Standards).
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 7601.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 7604(b).
    \24\ 15 U.S.C. 7603(b).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \25\ Labeling 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).
    \26\ See 16 CFR 456.2(a).

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[[Page 5446]]

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.
---------------------------------------------------------------------------

    \27\ The 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.
---------------------------------------------------------------------------

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

[[Page 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

[[Page 5448]]

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.


Sec. 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)).


Sec. 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 Sec. 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 non-business 
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 Sec. 315.5, means completed 
communication by telephone, facsimile, or electronic mail.
    Issue date, as used in Sec. 315.6, means the date on which the 
patient receives a copy of the prescription.

[[Page 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.


Sec. 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.


Sec. 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.


Sec. 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.


Sec. 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

[[Page 5450]]

    (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.


Sec. 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.


Sec. 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.


Sec. 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.


Sec. 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 Sec. 456.5 to read as follows:


Sec. 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