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					                                                                                            Wednesday,
                                                                                            February 4, 2004




                                                                                            Part VI

                                                                                            Federal Trade
                                                                                            Commission
                                                                                            16 CFR Parts 315 and 456
                                                                                            Contact Lens Rule; Ophthalmic Practice
                                                                                            Rules; Proposed Rule and Final Rule




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

      FEDERAL TRADE COMMISSION                                2738, contactlensrule@ftc.gov, Federal                  lenses.9 The contact lens market in the
                                                              Trade Commission, Bureau of Consumer                    United States is a multi-billion dollar
      16 CFR Parts 315 and 456                                Protection, Division of Advertising                     market. There are numerous
      RIN 3084–AA95                                           Practices, 600 Pennsylvania Avenue,                     manufacturers of contact lenses and
                                                              NW., Washington, DC 20580.                              many different channels of distribution,
      Contact Lens Rule; Ophthalmic                           SUPPLEMENTARY INFORMATION:                              including traditional eye care
      Practice Rules                                                                                                  practitioners (e.g., ophthalmologists and
                                                              I. Background                                           optometrists), national and regional
      AGENCY:  Federal Trade Commission.                      Fairness to Contact Lens Consumers Act                  optical chains, mass merchants (e.g.,
      ACTION: Notice of proposed rulemaking;
                                                                On December 6, 2003, President Bush                   Wal-Mart and Costco), and mail order
      request for public comment.                             signed the Fairness to Contact Lens                     and Internet firms.
                                                                                                                         The contact lens market has
      SUMMARY: In this document, the Federal                  Consumers Act (‘‘the Act’’).1 Among
                                                                                                                      undergone significant change in recent
      Trade Commission (the ‘‘Commission’’                    other things, the Act requires that
                                                                                                                      years. The development of disposable
      or ‘‘FTC’’) issues a Notice of Proposed                 prescribers—such as optometrists and
                                                                                                                      soft contact lenses, followed by the
      Rulemaking seeking comment on its                       ophthalmologists—provide contact lens
                                                                                                                      growth of ‘‘alternative’’ retail sources of
      proposed rule to implement the Fairness                 prescriptions to their patients upon the
                                                                                                                      contact lenses (e.g., non-eye care
      to Contact Lens Consumers Act (‘‘the                    completion of a contact lens fitting.2
                                                                                                                      practitioners), including mail order and
      Act’’), which provides for the                          The Act also mandates that prescribers                  Internet firms, and mass merchants, has
      availability of contact lens prescriptions              verify contact lens prescriptions to                    given consumers a greater choice of
      to patients and the verification of                     third-party contact lens sellers who are                sellers and means of delivery when they
      contact lens prescriptions by                           authorized by consumers to seek such                    purchase contact lenses. Such choice
      prescribers. This document also                         verification.3 Further, the Act directs                 can have important benefits to
      proposes two clerical amendments to                     the Commission to conduct a study to                    consumers. Competition among contact
      the Commission’s Ophthalmic Practice                    examine the strength of competition in                  lens sellers benefits consumers through
      Rules, which are designed to clarify the                the sale of prescription contact lenses,                lower prices, greater convenience, and
      distinction between those Rules and the                 including an examination of several                     improved product quality.
      proposed Contact Lens Rule.                             specified issues.4                                         Key to consumer choice among
                                                                The Act directs the Commission to                     contact lens sellers is the availability of
      DATES: Public comments must be
                                                              prescribe implementing rules.5 Any                      the contact lens prescription. To this
      received on or before April 5, 2004.                    violation of the Act or its implementing                end, the proposed Rule is designed to
      ADDRESSES: Comments should refer to                     rules constitutes a violation of a rule                 implement the Act’s specific provisions
      ‘‘Contact Lens Rule, Project No.                        under section 18 of the Federal Trade                   regarding the release and verification of
      R411002.’’ Comments filed in paper                      Commission Act, 15 U.S.C. 57a,                          contact lens prescriptions, and
      form should be mailed or delivered, as                  regarding unfair or deceptive acts or                   otherwise to further the Act’s goals of
      prescribed in the SUPPLEMENTARY                         practices.6 The Act also authorizes the                 ensuring the availability of such
      INFORMATION section, to the following                   Commission to investigate and enforce                   prescriptions so that consumers can
      address: Federal Trade Commission/                      the Act in the same manner, by the same                 choose among sellers when purchasing
      Office of the Secretary, Room 159–H,                    means, and with the same jurisdiction,                  contact lenses. The proposed Rule
      (Annex A) 600 Pennsylvania Avenue,                      powers, and duties, as a trade regulation               tracks the language of the Act very
      NW., Washington, DC 20580. Because                      rule under the Federal Trade                            closely:
      paper mail in the Washington area and                   Commission Act.7                                           • Section 315.1 describes the scope of
      at the Agency is subject to delay, please                 The Commission already enforces the                   the regulations under the Act.
      consider submitting your comments via                   Ophthalmic Practice Rules.8 These                          • Section 315.2 sets forth definitions
      electronic mail. Comments filed in                      Rules primarily require the release of                  for the terms used in the proposed Rule.
      electronic form (except comments                        eyeglass prescriptions to patients at the                  • Section 315.3 requires prescribers
      containing any confidential material)                   completion of an eye examination, and                   to provide patients with a copy of their
      should be sent, as prescribed in the                    prohibit eye care practitioners from                    contact lens prescription immediately
      SUPPLEMENTARY INFORMATION section, to                   placing certain conditions on such                      upon completion of a contact lens
      the following e-mail box:                               release. The Commission today                           fitting, and to provide or verify contact
      contactlensrule@ftc.gov. All Federal                    proposes two clerical amendments, set                   lens prescriptions to any third party
      Government agency rulemaking                            forth in sections III and XI below, to                  designated by a patient. This section
      initiatives are also available online at                clarify the relationship between the                    further prohibits prescribers from
      http://www.regulations.gov.                             Ophthalmic Practices Rules and the                      placing certain conditions on the release
         Comments on any proposed filing,                     proposed rule under the Fairness to                     or verification of a contact lens
      recordkeeping, or disclosure                            Contact Lens Consumers Act.                             prescription.
      requirements that are subject to                                                                                   • Section 315.4 limits the
      paperwork burden review under the                       II. Overview of the Proposed Contact
                                                                                                                      circumstances under which a provider
      Paperwork Reduction Act should                          Lens Rule
                                                                                                                      can require payment for an eye exam
      additionally be submitted to: Office of                    Nearly 36 million Americans—almost                   prior to releasing a contact lens
      Information and Regulatory Affairs,                     13% of all Americans—wear contact                       prescription to a patient.
      Office of Management and Budget, New                                                                               • Section 315.5 requires contact lens
      Executive Office Building, Room 10102,                       1 15  U.S.C. 7601–7610 (Pub. L. 108–164).          sellers to either obtain a copy of a
                                                                   2 Id. at 7601.
      Washington, DC 20503, Attention: Desk                                                                           patient’s prescription, or verify the
                                                                   3 Id. at 7601, 7603.
      Officer for Federal Trade Commission,                        4 Id. at 7609.
      as well as to the FTC Secretary at the                       5 Id. at 7607.
                                                                                                                         9 See Health Products Research (VIS)—Annual

      address above.                                                                                                  2000 Year-End Consumer Contact Lens Survey
                                                                   6 Id. at 7608.
                                                                                                                      (cited in ‘‘Trends in Contact Lenses & Lens Care,’’
      FOR FURTHER INFORMATION CONTACT:                             7 Id.
                                                                                                                      The Bausch & Lomb Annual Report to Vision Care
      Thomas Pahl or Kial Young, (202) 326–                        8 16 CFR part 456.                                 Professionals (Dec. 2001)).



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

      prescription, before selling contact                    at the same time allowing sellers to fill              and accurate filling of a prescription for
      lenses, and sets forth procedures for                   customer orders expeditiously.                         contact lenses, including the following:
      obtaining such verification. This section                  Business hour is defined under the                     (a) name of the patient;
      also addresses the issue of private label               proposed Rule to mean an hour between                     (b) date of examination;
      contact lenses.                                         9 a.m. and 5 p.m., during a weekday                       (c) issue date and expiration date of
         • Section 315.6 sets minimum                         (Monday through Friday), excluding                     prescription;
      expiration dates for contact lens                       Federal holidays. For purposes of                         (d) name, postal address, telephone
      prescriptions, with an exception for                    section 315.5(c)(3), ‘‘eight (8) business              number, and facsimile telephone
      cases involving the prescriber’s medical                hours’’ shall begin at the time that the               number of prescriber;
      judgment with respect to a patient’s                    seller provides the prescription                          (e) power, material or manufacturer or
      ocular health.                                          verification request to the prescriber and             both of the prescribed contact lens;
         • Section 315.7 prohibits certain                    conclude after eight (8) business hours                   (f) base curve or appropriate
      specified parties from representing that                have elapsed, except that the period for               designation of the prescribed contact
      contact lenses may be obtained without                  verification requests received during                  lens;
      a prescription.                                         non-business hours shall begin at 9 a.m.                  (g) diameter, when appropriate, of the
         • Section 315.8 prohibits prescribers                on the next weekday that is not a                      prescribed contact lens; and
      from using or requiring patients to sign                Federal holiday.                                          (h) in the case of a private label
      any waiver or disclaimer of liability for                  A few examples may help clarify how                 contact lens, name of the manufacturer,
      the accuracy of an eye examination.                     eight business hours would be                          trade name of the private label brand,
         • Section 315.9 establishes that                     calculated under the proposed                          and, if applicable, trade name of
      violations of the proposed Rule will be                 definition: (1) A response to a                        equivalent brand name.
      treated as violations of a rule defining                verification request received at 10:30                    This definition is taken almost
      an unfair or deceptive act or practice                  a.m. on Monday morning would be                        verbatim from the Act.
      under the FTC Act.                                      required by 10:30 a.m. on Tuesday                         Direct communication, as used in
         • Section 315.10 addresses the                       morning; (2) a response to a verification              section 315.5, includes a completed
      proposed Rule’s severability.                           request received at 10 p.m. on Monday                  communication through telephone,
         Following is an overview of the                      night would be required by 9 a.m. on                   facsimile, or electronic mail. This
      proposed Rule, with brief discussions                   Wednesday morning, i.e., eight business                definition sets forth the ways in which
      where needed. The full text of the                      hours after the verification period                    direct communication, as required in
      proposed Rule appears in section X of                   commences at 9 a.m. on Tuesday                         section 315.5 of the proposed Rule, may
      this document.                                          morning; (3) a response to a verification              occur—by telephone, facsimile, or
                                                              request received at 2 p.m. on Saturday                 electronic mail. The definition further
      Section 315.1 Scope of Regulations                                                                             requires that the communication
                                                              afternoon would be required by 9 a.m.
         Part 315, which shall be called the                  on Tuesday morning, i.e., eight business               involve a completed communication
      ‘‘Contact Lens Rule,’’ implements the                   hours after the verification period                    with the intended recipient. Thus,
      Fairness to Contact Lens Consumers                      begins at 9 a.m. on Monday morning;                    direct communication by telephone
      Act, codified at 15 U.S.C. 7601–7610.                   and (4) a response to a verification                   would require reaching and speaking
      The rules in part 315 of Title 16 of the                request received at 10:30 a.m. in the                  with the intended recipient, or leaving
      Code of Federal Regulations address                     morning on Columbus Day (a Monday)                     a voice message on the telephone
      release and verification of contact lens                would be required by 9 a.m. on                         answering machine of the intended
      prescriptions and related issues in                     Wednesday morning, i.e., eight business                recipient. Similarly, direct
      implementing the Act. In contrast, the                  hours after the verification period                    communication by facsimile or
      rules in part 456 of Title 16 (the                      commenced at 9 a.m. on Tuesday                         electronic mail would require that the
      ‘‘Ophthalmic Practices Rules’’ or                       morning.                                               intended recipient receive the facsimile
      ‘‘Eyeglass Rule’’) address the release of                  Commission means the Federal Trade                  or electronic mail message.
      eyeglass prescriptions and related                      Commission.                                               Issue date, as used in section 315.6,
      issues. See 16 CFR part 456.                               Contact lens fitting means the process              means the date on which the patient
         Section 315.1 describes the basis for,               that begins after an initial eye                       receives a copy of the prescription. This
      and the general scope of, the regulations               examination for contact lenses and ends                definition is taken directly from the Act.
      in part 315. It indicates that part 315                 when a successful fit has been achieved                   Ophthalmic goods are contact lenses,
      governs contact lens prescriptions and                  or, in the case of a renewal prescription,             eyeglasses, or any component of
      related issues, and clarifies that rules                ends when the prescriber determines                    eyeglasses. This term is not defined in
      applicable to eyeglass prescriptions are                that no change in the existing                         the Act, and so it has been defined
      found in part 456.                                      prescription is required, and such term                based on similar language in the
                                                              may include:                                           Eyeglass Rule.
      Section 315.2 Definitions                                                                                         Ophthalmic services are the
                                                                 (a) an examination to determine lens
         The Act states that a prescription is                specifications;                                        measuring, fitting, and adjusting of
      verified if, among other things, the                       (b) except in the case of a renewal of              ophthalmic goods subsequent to an eye
      prescriber fails to communicate with the                a contact lens prescription, an initial                examination. This term is not defined in
      seller within ‘‘eight business hours, or a              evaluation of the fit of the contact lens              the Act, and so it has been defined
      similar time as defined by [the FTC],’’                 on the eye; and                                        based on similar language in the
      after receiving proper verification                        (c) medically necessary follow-up                   Eyeglass Rule.
      information from the seller. Eight                      examinations.                                             Prescriber means, with respect to
      business hours’’ is not expressly defined                  This definition is taken almost                     contact lens prescriptions, an
      in the Act. The purpose of the time                     verbatim from the Act.                                 ophthalmologist, optometrist, or other
      period, however, is to give prescribers                    Contact lens prescription means a                   person permitted under State law to
      an adequate period of time during                       prescription, issued in accordance with                issue prescriptions for contact lenses in
      normal office hours to act upon a                       State and Federal law, that contains                   compliance with any applicable
      prescription verification request, while                sufficient information for the complete                requirements established by the Food


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

      and Drug Administration. This                           when appropriate; (3) the quantity of                  (e) No Alteration of Prescription
      definition is taken directly from the Act.              lenses ordered; (4) the date of the                       The Act prohibits a seller from
        Private Label Contact Lenses mean                     patient request; (5) the date and time of              altering a contact lens prescription of its
      contact lenses that are sold under the                  the verification request; and (6) the                  customer. The purpose of this
      label of a seller where the contact lenses              name of a contact person at the seller’s               requirement apparently is to make
      are identical to lenses made by the same                company, including a facsimile and a                   certain that consumers receive the
      manufacturer but sold under the labels                  telephone number. Section 315.5(b) of
                                                                                                                     contact lenses specified in their
      of other sellers. This definition is                    the proposed Rule incorporates these
                                                                                                                     prescription. The Act, however,
      derived from the Act.                                   requirements verbatim from the Act.
                                                                                                                     contains an exception to address so-
      Section 315.3 Availability of Contact                   (c) Verification Events                                called ‘‘private label’’ lenses. Some
      Lens Prescriptions to Patients                             The Act sets forth three circumstances              manufacturers make identical contact
         The Act requires prescribers to                      under which a seller can consider a                    lenses that are sold under multiple
      provide patients with a copy of their                   prescription verified and proceed to sell              labels, including the private labels of
      contact lens prescription upon                          contact lenses to its customer. Under the              particular providers. Prescribers may be
      completion of a contact lens fitting. It                Act, a prescription is verified if: (1) The            able to restrict consumer choice by
      also mandates that prescribers provide                  prescriber has confirmed the                           writing prescriptions that are limited to
      or verify contact lens prescriptions to                 prescription is accurate by direct                     specified private label contact lenses,
      third parties authorized to act on behalf               communication with the seller; (2) the                 even though these lenses are identical to
      of patients. The Act further prohibits                  prescriber has informed the seller that                other lenses made by the same
      prescribers from refusing to release or                 the prescription is inaccurate and                     manufacturer and sold by other sellers.
      verify a prescription unless their                      provides the accurate prescription; or                 To address such a restriction, the Act
      patients purchase contact lenses from                   (3) the prescriber fails to communicate                allows sellers to fill a prescription with
      them, pay a fee in addition to or as part               with the seller within eight (8) business              identical lenses manufactured by the
      of a examination fee, or sign a waiver or               hours (or a similar time period defined                same company even though the lenses
      release of liability. Section 315.3 of the              by the Commission) after receiving a                   are being sold under a different label
      proposed Rule is taken almost verbatim                  proper verification request from the                   than that specified on the prescription.
      from the Act.                                           seller.                                                Section 315.5(e) follows the Act in
                                                                 Section 315.5(c) sets forth these                   barring sellers from altering
      Section 315.4 Limits on Requiring                                                                              prescriptions and in allowing them to
                                                              circumstances, generally repeating the
      Immediate Payment                                                                                              substitute identical contact lenses for a
                                                              language of the Act. This provision
        The Act provides that prescribers can                 clarifies, however, that prescribers must              private label that a prescriber has
      require patients to pay a fee for an eye                use a method of direct communication                   specified on a prescription.
      examination, fitting, and evaluation                    (i.e., telephone, facsimile, or e-mail) in
      before the release of a contact lens                                                                           (f) Recordkeeping Requirement
                                                              conveying their response to the seller’s
      prescription only if the prescriber                     verification request. The method of                       The Act requires sellers to maintain
      requires immediate payment for an                       direct communication used by the                       records of all direct communications
      examination that reveals that the patient               prescriber to respond need not be the                  relating to prescription verification.
      does not need contact lenses or other                   same method of direct communication                    Section 315.5(f) proposes to require that
      ophthalmic goods. The Act treats                        that the seller used to send a verification            sellers maintain records of such
      presentation of proof of insurance                      request. For example, an eye care                      communications, as well as any
      coverage as a type of payment. Section                  practitioner may respond by telephone                  prescriptions they receive from patients
      315.4 of the proposed Rule is taken                     to a seller’s fax seeking verification. The            or prescribers, for a period of at least
      directly from the Act.                                  proposed Rule also does not include any                three years, and to have those records
      Section 315.5       Prescriber Verification             time period for responding to a                        available for inspection by the Federal
                                                              verification request other than the eight              Trade Commission. The purpose of
      (a) Prescription Requirement                            business hours mentioned in the Act.                   these recordkeeping requirements is to
         The Act states that a seller cannot sell                                                                    allow the Commission to investigate
                                                              (d) Invalid Prescription                               whether there has been a rule violation
      contact lenses to a customer unless the
      seller has obtained a copy of the                          The Act articulates the obligations of              and to seek civil penalties for any such
      patient’s contact lens prescription, or                 the parties if a seller submits a                      violations. Given that the statute of
      verified the prescription through a                     prescription for verification that the                 limitations for obtaining civil penalties
      direct communication with the                           prescriber determines is invalid. The                  for rule violations under the FTC Act is
      prescriber. Section 315.5(a) of the                     Act mandates that the prescriber must                  three years,10 a three-year document
      proposed Rule incorporates these                        specify for the seller the basis for                   retention requirement would assist the
      preconditions verbatim from the Act.                    concluding that any prescription is                    Commission in investigating and
                                                              invalid or inaccurate, and, if the                     challenging rule violations.
      (b) Information for Verification                        prescription is inaccurate, the prescriber             Nevertheless, the FTC is particularly
        The Act sets forth with specificity the               must provide the correct information to                interested in receiving comments
      information that a seller must provide to               the seller. The Act precludes a seller                 describing and documenting the costs
      the prescriber when seeking verification                from filling a contact lens prescription               and benefits of maintaining such
      of a contact lens prescription. Under the               that the prescriber has reported is                    records for three years.
      Act, the seller must provide the                        inaccurate, expired, or otherwise                         Section 315.5(f)(1) requires that
      prescriber with the following                           invalid, except that a seller may fill an              sellers keep copies of prescriptions or
      information through direct                              inaccurate prescription that the                       fax copies of prescriptions they receive
      communication: (1) The patient’s full                   prescriber has corrected. Section                      directly from a patient or a prescriber.
      name and address; (2) the contact lens                  315.5(d) of the proposed Rule follows                  The purpose of this requirement is to
      power, manufacturer, base curve or                      the procedures set forth in the Act for
      appropriate designation, and diameter                   addressing invalid prescriptions.                        10 Section   19(d) of the FTC Act, 15 U.S.C. 57b(d).



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

      document that it was permissible for the                a prescriber may specify a different                   under section 18 of the Federal Trade
      seller to sell contact lenses to the                    expiration date based on his or her                    Commission Act, 15 U.S.C. 57a,
      customer under section 7603(a)(1) of the                medical judgment with respect to the                   regarding unfair or deceptive acts or
      Act.                                                    ocular health of the patient. The                      practices. The Act further provides that
         Section 315.5(f)(2), consistent with                 purpose of establishing a minimum                      the Commission will enforce its
      section 7603(b) of the Act, also                        expiration date as a matter of Federal                 implementing rules in the same manner,
      mandates that sellers must maintain                     law is to prevent prescribers from                     by the same means, and with the same
      documentation of verification requests.                 selecting a short expiration date for a                jurisdiction, powers, and duties as are
      The documents that the proposed rules                   prescription that unduly limits the                    available to it pursuant to the Federal
      would require sellers to preserve vary                  ability of consumers to purchase contact               Trade Commission Act, 15 U.S.C. 41 et
      based on the means of direct                            lenses from other sellers, unless                      seq. Section 315.9 expressly
      communication the seller employed to                    legitimate medical reasons justify                     incorporates these provisions from the
      seek verification. If the seller                        setting such an expiration date.                       Act.
      communicates through facsimile or e-                       Section 315.6(a) of the proposed Rule
      mail, it must maintain a copy of the                    closely tracks the expiration date                     Section 315.10 Severability
      verification request and a confirmation                 requirements set forth in the Act, as                     Section 315.10 states that the
      of the completed communication of that                  described above. Section 315.6(b) sets                 provisions of the Contact Lens Rule are
      request, including the date and time the                forth the procedures that prescribers                  separate and severable from one
      communication was completed. On the                     must follow if they determine that                     another. If any provision is stayed or
      other hand, if the seller communicates                  legitimate medical reasons warrant an                  determined to be invalid, it thus is the
      through telephone, the seller must                      expiration date of less than one year.                 Commission’s intention that the
      maintain a telephone log: (1) Describing                Specifically, prescribers must document                remaining provisions will continue in
      the information that the seller provided                these medical reasons in the patient’s                 effect.
      to the prescriber (e.g., noting that the                medical record with sufficient detail to               III. Overview of the Proposed Clerical
      seller read the required prescription                   allow a qualified medical professional                 Amendments to the Ophthalmic
      information to the prescriber); (2)                     to determine the reasonableness of the                 Practice Rules (16 CFR Part 456)
      recording the date and time the                         shorter expiration date. As with the
      telephone call was completed; and (3)                   documents that sellers must maintain                      The Commission enforces the
      indicating how the call was completed                   pursuant to section 315.5(f) of the                    Ophthalmic Practice Rules, 16 CFR part
      (e.g., by speaking with someone directly                proposed Rule, section 315.6(b) requires               456, which primarily address acts and
      (and if so whom) or by leaving a                        that prescribers maintain these medical                practices related to eyeglasses, not
      message). In addition, for                                                                                     contact lenses. To clarify the
                                                              records for at least three years and that
      communications by telephone, the seller                                                                        relationship between the Ophthalmic
                                                              they must be available for inspection by
      must retain copies of its telephone bills.                                                                     Practice Rules and the proposed Contact
                                                              the Federal Trade Commission.
         Section 315.5(f)(3) further mandates                                                                        Lens Rule, the Commission hereby
      that the seller must maintain copies of                 Section 315.7 Content of                               proposes two clerical amendments to
      all prescription verification responses                 Advertisements and Other                               the Ophthalmic Practice Rules. The first
      from prescribers. Again, the specific                   Representations                                        amendment is to change the title of the
      documents to be maintained differ                         The Act provides that any person that                Ophthalmic Practices Rules to
      based on the method of direct                           engages in the manufacture, processing,                ‘‘Ophthalmic Practice Rules (Eyeglass
      communication that the prescriber used                  assembly, sale, offering for sale, or                  Rule).’’ The second amendment is to
      to contact the seller. If the response to               distribution of contact lenses may not                 add to the Ophthalmic Practice Rules a
      a verification request occurs via                       represent, by advertisement, sales                     cross-reference to the Contact Lens Rule.
      facsimile or e-mail, the seller must                    presentation, or otherwise, that contact               A similar cross-reference to the
      preserve a copy of the communication                    lenses may be obtained without a                       Ophthalmic Practice Rules is included
      and a record of the time and date it was                prescription. Section 315.7 incorporates               in section 315.1 of the proposed Contact
      received. If the response to a verification             this provision verbatim from the Act.                  Lens Rule. The Commission believes
      request is communicated via telephone,                                                                         modifying the title of the Ophthalmic
      then the seller must maintain a                         Section 315.8 Prohibition of Certain                   Practices Rules to include a reference to
      telephone log describing the                            Waivers                                                eyeglasses and including cross-
      information communicated and the date                     The Act provides that a prescriber                   references in both set of rules will help
      and time that it was received.                          may not place on the prescription, or                  direct businesses and consumers to
                                                              require the patient to sign, or deliver to             applicable regulatory provisions.11
      Section 315.6 Expiration of Contact
                                                              the patient, a form or notice waiving or               IV. Invitation to Comment
      Lens Prescriptions
                                                              disclaiming the liability or
         The Act provides that if the expiration                                                                       Comments from members of the
                                                              responsibility of the prescriber for the
      date for a contact lens prescription                                                                           public are invited, and may be filed
                                                              accuracy of the eye examination. The
      under state law is one year or more after                                                                      with the Commission in either paper or
                                                              Act further provides that this provision
      its issue date, then the prescription shall                                                                    electronic form. The Commission will
                                                              does not impose liability on a prescriber
      expire on the date specified by State                                                                          give consideration to any written
                                                              for the ophthalmic goods and services
      law. The Act also states that if the                                                                           comments concerning the proposed
                                                              dispensed by another seller pursuant to
      expiration date for a contact lens                      the prescriber’s correctly verified                      11 Because the proposed amendments are clerical,
      prescription under State law is less than               prescription. Section 315.8 incorporates               not substantive, in nature, they are exempt from the
      one year after its issue date, or the State             these provisions verbatim from the Act.                rulemaking requirements that would apply to any
      law does not specify an expiration date,                                                                       substantive amendments to the Ophthalmic Practice
      then the prescription shall expire not                  Section 315.9 Enforcement                              Rules. See 18 U.S.C. 57(d)(1)(B). Nonetheless, in an
                                                                                                                     exercise of its discretion, the Commission seeks
      less than one year after its issue date.                  The Act provides that any violation of               comment on the proposed amendments in
      Notwithstanding these expiration                        the Act or rules implementing the Act                  conjunction with the comments it seeks on the
      standards, the Act further provides that                shall be treated as a violation of a rule              proposed Contact Lens Rule.



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

      Contact Lens Rule and the clerical                      imposes certain disclosure and                         complying with the disclosure
      amendments to the Ophthalmic Practice                   recordkeeping requirements on contact                  requirement [(36 million × 1 minute) /
      Rules submitted on or before April 5,                   lens prescribers and sellers.                          60 minutes = 600,000].15 At an average
      2004.                                                   Specifically, the Rule requires                        wage for prescribers of $42.00 per
         A public comment filed in paper form                 prescribers to provide a copy of a                     hour,16 complying with this
      should be mailed or delivered to the                    patient’s contact lens prescription to the             requirement imposes an estimated $25.2
      following address: Federal Trade                        patient or an authorized third party                   million labor cost burden on prescribers
      Commission/Office of the Secretary,                     upon completion of a contact lens                      [$42.00 × 600,000 hours = $25.2
      Room 159–H, (Annex A) 600                               fitting, and further requires prescribers              million].17 In addition, the staff
      Pennsylvania Avenue, NW.,                               to document in their patients’ records                 estimates that contact lens sellers will
      Washington, DC 20580. If the comment                    the medical reasons for setting a contact              spend an average of five (5) minutes per
      contains any material for which                         lens prescription expiration date of less              sale of contact lenses complying with
      confidential treatment is requested, it                 than one year.13 In addition, the Rule                 the recordkeeping requirements. Based
      must be filed in paper (rather than                     requires contact lens sellers to maintain              on its knowledge of the industry, the
      electronic) form, and the first page of                 records for three years of all direct                  staff estimates that approximately 10%
      the document must be clearly labeled                    communications involved in obtaining                   of contact lens sales (i.e., sales by mail
      ‘‘Confidential.’’ 12                                    verification of a contact lens                         order and Internet-based sellers) will be
         A public comment that does not                       prescription, as well as prescriptions, or             subject to the recordkeeping
      contain any material for which                          copies thereof, which they receive                     requirements, 3.6 million consumers’
      confidential treatment is requested may                 directly from customers or prescribers.14              prescriptions or verifications will need
      instead be filed in electronic form (in                    The Commission staff estimates the                  to be retained, for a total of 300,000
      ASCII format, WordPerfect, or Microsoft                 paperwork burden of the Act and                        hours spent on recordkeeping [(3.6
      Word), as part of or as an attachment to                proposed Rule, based on its knowledge                  million × 5 minutes) / 60 minutes =
      an e-mail message sent to the following                 of the eye care industry. The staff                    300,000 hours]. At an average wage for
      e-mail box: contactlensrule@ftc.gov.                    believes there will be some burden on                  clerical personnel of $10.00 per hour,
         Regardless of the form in which they                 individual prescribers to provide                      complying with this requirement
      are filed, all timely comments will be                  contact lens prescriptions, although it                imposes an estimated $3 million labor
      considered by the Commission, and will                  involves merely writing a few pieces of                cost burden on contact lens sellers
      be available (with confidential material                information onto a slip of paper and                   [$10.00 × 300,000 hours = $3 million].18
      redacted) for public inspection and                     handing it to the patient, or perhaps                    The Commission invites comments
      copying on the Commission Web site at                   mailing or faxing it to a third party. The             that will enable it to: (1) Evaluate
      http://www.ftc.gov and at its principal                 burden of documenting the medical                      whether the proposed collections of
      office. As a matter of discretion, the                  reasons for setting a prescription                     information are necessary for the proper
      Commission makes every effort to                        expiration date shorter than one year                  performance of the functions of the
      remove home contact information for                     will be minimal, because such                          Commission, including whether the
      individuals from the public comments it                 expiration dates presumably will be set                information will have practical utility;
      receives, before placing those comments                 in a relatively limited number of cases,               (2) evaluate the accuracy of the
      on the FTC Web site.                                    and because such records are likely kept               Commission’s estimate of the burden of
      V. Communications by Outside Parties                    in the ordinary course of business in                  the proposed collections of information,
      to Commissioners or Their Advisors                      any event. In addition, there will be                  including the validity of the
        Written communications and                            some recordkeeping burden on contact                   methodology and assumptions used; (3)
      summaries or transcripts of oral                        lens sellers—including retaining                       enhance the quality, utility, and clarity
      communications respecting the merits                    prescriptions or records of ‘‘direct                   of the information to be collected; and
      of this proceeding from any outside                     communications’’—pertaining to each                    (4) minimize the burden of the
      party to any Commissioner or                            sale of contact lenses to consumers who                collections of information on those who
      Commissioner’s advisor will be placed                   received their original prescription from              must comply, including through the use
      on the public record. See 16 CFR                        a third party prescriber.                              of appropriate automated, electronic,
                                                                 Overall, the Commission staff has                   mechanical, or other technological
      1.26(b)(5).
                                                              estimated that the average annual                      techniques or other forms of information
      VI. Paperwork Reduction Act                             burden during the three-year period for                technology.
         The Commission has submitted this                    which OMB clearance is sought will be
      proposed Rule and a Supporting                          900,000 burden hours. The estimated                      15 The staff estimates that prescribers will not

      Statement for Information Collection                    annual labor cost associated with these                spend any additional time complying with the
                                                              paperwork burdens is $28.2 million.                    recordkeeping requirement that they record the
      Provisions to the Office of Management                                                                         medical reasons for setting a prescription expiration
      and Budget (‘‘OMB’’) for review under                   Specifically, the staff estimates that                 date shorter than one year. This is because
      the Paperwork Reduction Act of 1995                     prescribers will spend an average of one               instances of shorter expiration dates will occur
      (‘‘PRA’’), 44 U.S.C. 3501–3517. As                      (1) minute providing each prescription                 relatively infrequently and the required medical
                                                              to a patient or authorized third party.                information is likely to be recorded in the ordinary
      required by the Fairness to Contact Lens                                                                       course of business in any event.
      Consumers Act, the proposed Rule                        Based on its knowledge of the industry,                  16 The Bureau of Labor Statistics reports an
                                                              the staff estimates that there are 36                  average wage for salaried optometrists of $42.00 per
        12 Commission Rule 4.2(d), 16 CFR 4.2(d). The         million contact lens wearers in the                    hour.
      comment must also be accompanied by an explicit         United States who visit their eye care                   17 This estimate overstates the actual burden, in

      request for confidential treatment, including the       practitioner annually, and thus                        fact, because prescribers in more than two-thirds of
      factual and legal basis for the request, and must                                                              the States already provide prescriptions to at least
      identify the specific portions of the comment to be
                                                              prescribers will spend 600,000 hours                   some of their patients as required by State Law.
      withheld from the public record. The request will                                                                18 Again, this estimate overstates that actual
                                                                13 See proposed Rule sections 315.3(a),
      be granted or denied by the Commission’s General                                                               burden, because some mail order and Internet-based
      Counsel, consistent with applicable law and the         315.6(b)(1); see also 15 U.S.C. 7601(a), 7604(b)(1).   contact lens sellers already maintain records
      public interest. See Commission Rule 4.9(c), 16 CFR       14 See proposed Rule section 315.5(f); see also 15   relating to contact lens prescriptions and
      4.9(c).                                                 U.S.C. 7603(b).                                        verification.



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

      VII. Regulatory Flexibility Act                          Fairness to Contact Lens Consumers                     communications, as well as
         The Regulatory Flexibility Act                        Act. The legal basis for the proposed                  prescriptions they receive directly from
      (‘‘RFA’’), 5 U.S.C. 601–612, requires an                 Rule is the Act itself, 15 U.S.C. 7601–                the patient or prescriber, for a period of
      agency to provide an Initial Regulatory                  7610.                                                  at least three years. The specific records
      Flexibility Analysis (‘‘IRFA’’) with a                   C. Description of and, Where Feasible,                 a seller must retain vary depending on
      proposed rule and a Final Regulatory                     Estimate of the Number of Small                        the manner of communication. If the
      Flexibility Analysis (‘‘FRFA’’) with the                 Entities to Which the Proposed Rule                    communication occurs through
      final rule, if any, unless the agency                    Will Apply                                             facsimile or email, the seller must retain
      certifies that the rule will not have a                                                                         a copy of the verification request, a
                                                                 In general, the proposed Rule applies                confirmation of the completed
      significant economic impact on a
                                                               to both ‘‘prescribers’’ and ‘‘sellers’’ of             communication of that request
      substantial number of small entities. See
                                                               contact lenses. The FTC staff believes                 (including the date and time the
      5 U.S.C. 603–605.
         The FTC does not expect that the                      that many prescribers will fall into the               communication was completed), and
      proposed Contact Lens Rule will have a                   category of small entities (e.g., Offices of           any response from the provider. If the
      significant economic impact on a                         Optometrists less than $6 million in                   communication occurs through
      substantial number of small entities.                    size), but that, for the most part, sellers            telephone, the required record consists
      The Fairness to Contact Lens Consumers                   subject to the Rule’s recordkeeping                    of a telephone log describing the
      Act 19 expressly mandates most, if not                   requirements likely will be larger                     information provided, the date and time
      all, of the proposed Rule’s requirements,                businesses (e.g., Mail Order Houses or                 of the telephone call, and how the call
      and thus accounts for most, if not all, of               Electronic Shopping entities greater                   was completed (e.g., by speaking with
      the economic impact of the proposed                      than $21 million in size).21 Determining               someone directly or leaving a message).
      Rule. In any event, the burdens most                     a precise estimate of the number of                    For telephone communications the
      likely to be imposed on small entities                   small entities covered by the Rule’s                   seller also must retain its telephone bill.
      (which are likely to be contact lens                     disclosure and recordkeeping                           The proposed Rule requires that the
      prescribers)—such as providing contact                   requirements is not readily feasible. The              records be available for inspection by
      lens prescriptions to patients or their                  Commission invites comment and                         the Commission, but does not otherwise
      agents, recording the medical reasons                    information on this issue.                             require production of the records.
      for setting prescription expiration dates                D. Projected Reporting, Recordkeeping                     The Commission is seeking clearance
      of less than one year, and verifying                     and Other Compliance Requirements,                     from the Office of Management and
      prescription information—are likely to                   Including an Estimate of the Classes of                Budget (‘‘OMB’’) for these requirements
      be relatively small. The more significant                Small Entities That Will Be Subject to                 and the Commission’s Supporting
      burdens imposed by the Rule likely will                  the Requirement and the Type of                        Statement submitted as part of that
      fall primarily on larger sellers of contact              Professional Skills Necessary for                      process will be made available on the
      lenses, which are more likely to be                      Preparation of the Report or Record                    public record of this rulemaking. As set
      seeking verification of prescriptions and                  As mandated by the Act, the proposed                 forth in section VI above, the
      thus triggering the Act’s more                           Rule imposes disclosure and                            Commission staff has estimated that the
      significant recordkeeping requirements.                  recordkeeping requirements, within the                 proposed Rule’s disclosure and
         This document serves as notice to the                                                                        recordkeeping requirements referenced
                                                               meaning of the Paperwork Reduction
      Small Business Administration of the                                                                            above will require an average annual
                                                               Act, on contact lens prescribers and
      agency’s certification of no effect.                                                                            burden of 600,000 hours on prescribers,
                                                               sellers. With respect to disclosure, the
      Nonetheless, the Commission has                                                                                 for a total annual labor cost of $25.2
                                                               Rule requires prescribers to provide
      determined that it is appropriate to                                                                            million, and an average annual burden
                                                               patients with a copy of their contact
      publish an IRFA in order to inquire into                                                                        on sellers of 300,000 hours on sellers,
                                                               lens prescription upon completion of a
      the impact of the proposed Rule on                                                                              for a total annual labor cost of $3
                                                               contact lens fitting, and to provide such
      small entities. Therefore, the                                                                                  million.
                                                               prescriptions to third parties authorized
      Commission has prepared the following
                                                               to act on behalf of patients.22                        E. Other Duplicative, Overlapping, or
      analysis.                                                  The Rule also implements several                     Conflicting Federal Rules
      A. Description of the Reasons That                       recordkeeping requirements. First, in
                                                               cases in which a prescriber sets a                       The FTC believes there are no other
      Action by the Agency Is Being
                                                               contact lens prescription expiration date              Federal statutes, rules, or policies that
      Considered
                                                               shorter than one year, the prescriber                  would conflict with the proposed Rule.
        The Fairness to Contact Lens                                                                                  In fact, the proposed Rule reinforces the
                                                               must document in the patient’s record
      Consumers Act directs the Commission                                                                            existing Federal requirement that
                                                               the medical reasons justifying the
      to prescribe rules implementing the Act                                                                         contact lenses be sold only pursuant to
                                                               shorter expiration date.23 Section
      not later than 180 days after the Act                                                                           a prescription,25 and complements the
                                                               315.5(f) of the proposed Rule requires
      takes effect on February 4, 2004.20                                                                             Commission’s existing Ophthalmic
                                                               that such records be kept for three (3)
      Accordingly, the Commission has                                                                                 Practices Rule’s requirement that
                                                               years. Second, the Act requires sellers to
      prepared the proposed Contact Lens                                                                              prescribers provide patients with a copy
                                                               maintain records of all direct
      Rule announced in this document.                                                                                of their eyeglass prescription upon the
                                                               communications relating to prescription
      B. Succinct Statement of the Objectives                  verification.24 Accordingly, section                   completion of an eye examination.26
      of, and Legal Basis for, the Proposed                    315.5(f) of the proposed Rule requires
                                                                                                                        25 Labeling regulations of the Food and Drug
      Rules                                                    that sellers maintain records of such
                                                                                                                      Administration effectively require that contact
        As set forth above, the objective of the                 21 See 12 CFR 121.201 (Small Business
                                                                                                                      lenses are sold only pursuant to a prescription.
      proposed Contact Lens Rule is to                                                                                Certain devices, such as contact lenses, when sold
                                                               Administration’s Table of Small Business Size          without a prescription and without adequate
      implement the requirements of the                        Standards).                                            directions for use on the label, are ‘‘misbranded’’ in
                                                                 22 15 U.S.C. 7601.
                                                                                                                      violation of the Food, Drug & Cosmetics Act. See
        19 15   U.S.C. 7601–7610.                                23 15 U.S.C. 7604(b).                                21 U.S.C. 352(f); 21 CFR 801.109(a)(2).
        20 15   U.S.C. 7607.                                     24 15 U.S.C. 7603(b).                                  26 See 16 CFR 456.2(a).




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

      F. Description of Any Significant                       Rule. Include in your comments the                     become effective no later than 180 days
      Alternatives to the Proposed Rule That                  number of small entities that will be                  after the effective date of the Act.28 The
      Would Accomplish the Stated                             required to comply with the Rule’s                     FTC intends to issue final rules with an
      Objectives of Applicable Statutes and                   disclosure and recordkeeping                           effective date within the time specified
      That Minimize Any Significant                           requirements.                                          in the Act. The Commission will
      Economic Impact of the Proposed Rule                       2. Please provide comment on any or                 announce a specific effective date for
      on Small Entities, Including Alternatives               all of the provisions in the proposed                  the Contact Lens Rule when it issues its
      Considered, Such as: (1) Establishment                  Rule with regard to (a) the impact of the              final rule.
      of Differing Compliance or Reporting                    provision(s) (including benefits and                   IX. Questions on the Proposed Contact
      Requirements or Timetables That Take                    costs), if any, and (b) what alternatives,             Lens Rule and the Proposed Clerical
      Into Account the Resources Available to                 if any, the Commission should consider,                Amendments to the Ophthalmic
      Small Entities; (2) Clarification,                      as well as the costs and benefits of those             Practice Rules
      Consolidation, or Simplification of                     alternatives, paying specific attention to
      Compliance and Reporting                                the effect of the proposed Rule on small                 The Commission is seeking comment
      Requirements Under the Rule for Such                    entities in light of the above analysis. In            on various aspects of the proposed
      Small Entities; (4) Any Exemption From                  particular, please provide the above                   Contact Lens Rule, and is particularly
      Coverage of the Rule, or Any Part                       information with regard to the                         interested in receiving comment on the
      Thereof, for Such Small Entities                        disclosure and recordkeeping provisions                questions that follow. These questions
                                                              of the proposed Rule set forth in                      are designed to assist the public and
         The proposed Rule’s disclosure and                                                                          should not be construed as a limitation
      recordkeeping requirements are                          sections 315.3(a), 315.5(f), and 315.6(b),
                                                              and describe any ways in which the                     on the issues on which public comment
      designed to impose the minimum                                                                                 may be submitted. Responses to these
      burden on all affected members of the                   proposed Rule could be modified to
                                                              reduce any costs or burdens for small                  questions should cite the numbers and
      industry, regardless of size. The Act                                                                          subsection of the questions being
      itself does not allow the Commission                    entities consistent with the Act’s
                                                              mandated requirements. Costs to                        answered. For all comments submitted,
      any latitude to treat small businesses                                                                         please submit any relevant data,
      differently, such as by exempting a                     ‘‘implement and comply’’ with the
                                                              proposed Rule include expenditures of                  statistics, or any other evidence, upon
      particular category of firm or setting                                                                         which those comments are based.
      forth a lesser standard of compliance for               time and money for: any employee
      any category of firm. However, the                      training; attorney, computer                           General Questions
      burdens imposed by the Act and                          programmer or other professional time;                    1. Please provide comment on any or
      proposed Rule on small businesses are                   preparing relevant materials (i.e.,                    all of the provisions in the proposed
      likely to be relatively limited. The small              prescriptions for release), and                        Contact Lens Rule and the proposed
      businesses affected by the Rule are                     recordkeeping.                                         clerical amendments to the Ophthalmic
      likely to consist primarily of contact                     3. Please describe ways in which the                Practice Rules. For each provision
      lens prescribers in solo or small                       Rule could be modified to reduce any                   commented on please describe (a) the
      practices. Their burdens under the Rule                 costs or burdens on small entities                     impact of the provision(s) (including
      primarily would entail providing                        consistent with the Act’s mandated                     benefits and costs), if any, and (b) what
      contact lens prescriptions to patients or               requirements, including whether and                    alternatives, if any, the Commission
      their agents, documenting in                            how technological developments could                   should consider, as well as the costs and
      exceptional cases the medical reasons                   reduce the costs of implementing and                   benefits of those alternatives.
      for setting a contact lens prescription                 complying with the proposed Rule for                      2. Please provide comment on the
      date of less than one year, and verifying               small entities.                                        effect of the proposed Contact Lens Rule
      prescriptions for some of their patients                   4. Please provide any information                   on the costs, profitability, and
      who seek to purchase their contact                      quantifying the economic benefits of the               competitiveness of, and employment in,
      lenses from another seller. Thus, the                   proposed Rule on the entities covered                  small entities.
      Commission does not believe that the                    by the Act, including small entities.
                                                                 5. Please identify any relevant                     Questions Pertaining to the Proposed
      proposed Rule will impose a significant                                                                        Contact Lens Rule
      economic impact on a substantial                        Federal, State, or local rules that may
      number of small businesses.                             duplicate, overlap or conflict with the                Definitions
         Nonetheless, the Commission                          proposed Rule. In addition, please                        3. Section 315.2 defines ‘‘business
      specifically requests comment on the                    identify any industry rules or policies                hour.’’ (a) Is this definition sufficiently
      question whether the proposed Rule                      that require covered entities to engage in             clear?
      imposes a significant impact upon a                     business practices that would already                     (b) What is the impact, including
      substantial number of small entities,                   comply with the requirements of the                    costs and benefits, of defining the term
      and what modifications to the Rule the                  proposed Rule.                                         in this way? (c) Should the definition
      Commission could make to minimize                       VIII. Effective Date                                   include provisions addressing (i)
      the burden on small entities. Moreover,                                                                        prescriber vacation days, (ii) State or
      the Commission requests comment on                        The Act takes effect on February 4,                  local holidays, (iii) weekend days, or
      the general question whether new                        2004,27 and thus prescribers and sellers               (iv) other exceptions to normal business
      technology or changes in technology can                 of contact lenses, and other parties                   hours?
      be used to reduce the burdens mandated                  covered by the Act, have a legal                          4. Section 315.2 defines ‘‘contact lens
      by the Act.                                             obligation to comply with the Act as of                fitting.’’ (a) Is this definition sufficiently
                                                              that date. The Act directs the                         clear? (b) What is the impact, including
      Questions for Comment To Assist                         Commission to prescribe rules that will                costs and benefits, of defining the term
      Regulatory Flexibility Analysis                                                                                in this way? (c) Should the term
                                                                27 The Act becomes effective 60 days after the
        1. Please provide information or                      date of its enactment, which was December 6, 2003.     ‘‘medically necessary follow-up
      comment on the number and type of                       See Pub. L. 108–164, section 12 (set out as note
      small entities affected by the proposed                 under 15 U.S.C. 7601).                                   28 15   U.S.C. 7607.



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

      examinations’’ be defined, and, if so,                  Availability of Contact Lens                           needs in order to verify a contact lens
      how?                                                    Prescriptions to Patients                              prescription? (d) If prescribers receive
         5. Section 315.2 defines ‘‘contact lens                 13. Section 315.3(a) requires                       the name of a contact person at the
      prescription.’’ (a) Is this definition                  prescribers to release and verify contact              seller, as well as his or her telephone
      sufficiently clear? (b) What is the                     lens prescriptions to their patients and               number and fax number, is this
      impact, including costs and benefits, of                                                                       sufficient to enable a prescriber to
                                                              to any person designated to act on
      defining the term in this way? (c)                                                                             respond to a verification request within
                                                              behalf of the patient. (a) Is this provision
      Should the definition include the                                                                              eight (8) business hours as defined in
                                                              sufficiently clear? (b) Is it clear the
      prescriber’s e-mail address, if any? (d)                                                                       section 315.5(c)?
                                                              means by which a prescriber shall                         18. Section 315.5(c) defines the
      Should the definition include anything                  provide or verify a contact lens
      else?                                                                                                          circumstances under which a contact
                                                              prescription as directed by a third party              lens prescription is deemed verified. (a)
         6. Should the Commission define                      authorized to act on behalf of the                     Is this provision sufficiently clear? (b)
      ‘‘contact lenses’’ for purposes of the Act,             patient?                                               What is the impact, including costs and
      and, if so, should such definition                         14. Section 315.3(b) prohibits                      benefits, of this provision? (c) Is there a
      specifically exclude non-corrective or                  prescribers from imposing certain                      different time period that is similar to
      ‘‘cosmetic’’ contact lenses, because                    requirements or conditions on patients                 eight business hours, as set forth in
      consumers do not need a prescription to                 prior to releasing or verifying contact                section 315.5(c)(3), that would give
      purchase them?                                          lens prescriptions, including charging                 prescribers an adequate period of time
         7. Section 315.2 defines ‘‘direct                    them any fee in addition to the fee for                during normal office hours to act upon
      communication.’’ (a) Is this definition                 an eye examination, fitting, and                       a prescription verification request and
      sufficiently clear? (b) What is the                     evaluation to receive a prescription or to             still allow sellers to fill customer orders
      impact, including costs and benefits, of                have a prescription verified. (a) Do                   expeditiously? (d) What would be the
      defining the term in this way? (c) Is it                prescribers itemize charges and fees in                impact, including costs and benefits, of
      appropriate to include messages left on                 a manner that distinguishes the amount                 such other time period? (e) Does the
      telephone answering machines in this                    the patient is paying for an eye                       Health Insurance Portability and
      definition? (d) Should the definition                   examination, fitting, and evaluation                   Accountability Act of 1996 (‘‘HIPAA’’)
      expressly require, for communication by                 from the amount he or she is paying for                limit or otherwise affect prescribers’
      facsimile or e-mail, the receipt of a                   other goods and services? (b) Are there                ability to respond to a verification
      confirmation that the communication                     additional requirements or conditions                  request pursuant to section 315.5(c)
      was successful? (e) Should the                          that should be prohibited to facilitate                and/or section 315.5(d)?
      definition include any other means of                   the release and verification of contact                   19. Section 315.5(d) prohibits a
      direct communication?                                   lens prescriptions? (c) What would be                  contact lens seller from filling a
         8. Section 315.2 defines ‘‘issue date.’’             the impact, including costs and benefits,              prescription if the prescriber provides
      (a) Is this definition sufficiently clear?              of such additional prohibitions?                       timely notice to the seller that the
      (b) Is this term currently defined under                Limits on Requiring Immediate Payment                  prescription is inaccurate, expired, or
      State laws relating to contact lens                                                                            otherwise invalid, unless the prescriber
      prescriptions? (c) What is the impact,                    15. Section 315.4 limits the                         has corrected the inaccuracy. (a) Is this
      including costs and benefits, of defining               circumstances under which a prescriber                 provision sufficiently clear? (b) Should
      the term in this way?                                   may require immediate payment for fees                 the Commission specifically define
                                                              for an eye examination, fitting, and                   inaccurate, invalid, and expired
         9. Section 315.2 defines ‘‘ophthalmic
                                                              evaluation prior to releasing a contact                prescriptions, and, if so, what should
      goods.’’ (a) Is this definition sufficiently
                                                              lens prescription. Is this provision                   those definitions include? (c) What is
      clear? (b) Is there any reason that
                                                              sufficiently clear?                                    the impact, including the costs and
      ophthalmic goods should be defined
      differently for purposes of the proposed                Prescriber Verification                                benefits, of this provision?
      Contact Lens Rule and the Ophthalmic                                                                              20. Section 315.5(e) prohibits sellers
                                                                16. Section 315.5(a) sets forth the                  from altering contact lens prescriptions,
      Practice Rules? (c) What is the impact,                 circumstances under which contact lens
      including costs and benefits, of defining                                                                      but allows them to substitute identical
                                                              sellers may sell contact lenses to a                   contact lenses from the same
      the term in this way?                                   patient. (a) Is this provision sufficiently            manufacturer for private label lenses
         10. Section 315.2 defines ‘‘ophthalmic               clear, and, if not, what should be                     specified on a prescription. (a) Is this
      services.’’ (a) Is this definition                      clarified? (b) Should the Commission                   provision sufficiently clear? (b) What is
      sufficiently clear? (b) Is there any reason             specify, for purposes of paragraph (a)(1),             the impact, including costs and benefits,
      that ophthalmic services should be                      that either the original or a copy of a                of this provision?
      defined differently for purposes of the                 prescription will suffice? (c) Are there                  21. Section 315.5(f) requires contact
      proposed Contact Lens Rule and the                      additional requirements the                            lens sellers to maintain for three (3)
      Ophthalmic Practice Rules? (c) What is                  Commission should consider imposing,                   years records of prescriptions received,
      the impact, including costs and benefits,               and what would be the impact,                          direct communications with prescribers
      of defining the term in this way?                       including costs and benefits, of such                  to verify prescriptions, and responses
         11. Section 315.2 defines                            additional requirements?                               from prescribers to these requests for
      ‘‘prescriber.’’ (a) Is this definition                    17. Section 315.5(b) sets forth the                  verification. (a) Is this provision
      sufficiently clear? (b) What is the                     information a contact lens seller must                 sufficiently clear? (b) What is the
      impact, including costs and benefits, of                provide to a prescriber when the seller                impact, including costs and benefits, of
      defining the term in this way?                          seeks verification of a contact lens                   this provision—particularly with
         12. Section 315.2 defines ‘‘private                  prescription. (a) Is this provision                    respect to the types of documents and
      label contact lenses.’’ (a) Is this                     sufficiently clear? (b) What is the                    the length of time they must be
      definition sufficiently clear? (b) What is              impact, including costs and benefits, of               retained? (c) Are there additional items
      the impact, including costs and benefits,               this provision? (c) Is there any                       the Commission should require be
      of defining the term in this way?                       additional information a prescriber                    maintained? (d) How can the


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

      Commission minimize the burden on                       Questions on the Proposed Clerical                     § 315.2   Definitions.
      sellers imposed by the recordkeeping                    Amendments to the Ophthalmic                              Business hour means an hour between
      requirement? (e) Are there technological                Practice Rules                                         9 a.m. and 5 p.m., during a weekday
      means available to provide confirmation                                                                        (Monday through Friday), excluding
      to the sender that an email has been                       27. The Commission proposes                         Federal holidays. For purposes of
      received by the intended recipient?                     amending the title of 16 CFR Part 456                  § 315.5(d)(3), ‘‘eight (8) business hours’’
                                                              to read: Ophthalmic Practice Rules                     shall be calculated from the first
      Expiration of Contact Lens Prescriptions                (Eyeglass Rule). What is the impact, if                business hour that occurs after the seller
         22. Section 315.6(a) establishes a                   any, of such an amendment and would                    provides the prescription verification
      minimum contact lens prescription                       it effect any substantive change to the                request to the prescriber, and shall
      expiration date of one year, subject to an              Rules?                                                 conclude after eight (8) business hours
      exception based on the medical                             28. The Commission proposed adding                  have elapsed. For verification requests
      judgment of a prescriber. (a) Is this                   a new paragraph 456.5 to the                           received by a prescriber during non-
      provision sufficiently clear? (b) What is               Ophthalmic Practices Rules to provide a                business hours, the calculation of ‘‘eight
      the impact, including the costs and                     cross-reference to the Contact Lens Rule.              (8) business hours’’ shall begin at 9 a.m.
      benefits, of this provision?                            What is the impact, if any, of such an                 on the next weekday that is not a
         23. Section 315.6(b) sets forth special              amendment and would it effect any                      Federal holiday.
      rules for contact lens prescriptions that               substantive change to the Rules?                          Commission means the Federal Trade
      expire in less than one year, including                                                                        Commission.
      a requirement that prescribers document                 X. Proposed Contact Lens Rule and
                                                                                                                        Contact lens fitting means the process
      the specific reasons for the medical                    Clerical Amendments to the
                                                                                                                     that begins after an initial eye
      judgment on which the shorter                           Ophthalmic Practice Rules (16 CFR
                                                                                                                     examination for contact lenses and ends
      expiration date is based. (a) Is this                   Part 456)
                                                                                                                     when a successful fit has been achieved
      provision sufficiently clear? (b) What is               List of Subjects in 16 CFR Parts 315 and               or, in the case of a renewal prescription,
      the impact, including the costs and                     456                                                    ends when the prescriber determines
      benefits, of this provision? (c) In what                                                                       that no change in the existing
      circumstances would there be legitimate                   Advertising, Medical devices,                        prescription is required, and such term
      medical reasons for setting a contact                   Ophthalmic goods and services, Trade                   may include:
      lens prescription expiration date of less               practices.                                                (1) An examination to determine lens
      than one year? (d) How can the                            Accordingly, for the reasons stated in               specifications;
      Commission minimize the burden on                       the preamble, the Federal Trade                           (2) Except in the case of a renewal of
      prescribers imposed by the                              Commission proposes to amend 16 CFR                    a contact lens prescription, an initial
      documentation requirement and the                       chapter I as follows:                                  evaluation of the fit of the contact lens
      three-year time period for retention? (e)                 1. Add a new part 315 to subchapter                  on the eye; and
      For how long do prescribers currently                   C to read as follows:                                     (3) Medically necessary follow-up
      retain medical records for their contact                                                                       examinations.
      lens patients?                                          PART 315—CONTACT LENS RULE                                Contact lens prescription means a
                                                                                                                     prescription, issued in accordance with
      Content of Advertisements and Other                     Sec.                                                   State and Federal law, that contains
      Representations                                         315.1 Scope of regulations in this part.
                                                                                                                     sufficient information for the complete
         24. Section 315.7 prohibits the                      315.2 Definitions.
                                                              315.3 Availability of contact lens                     and accurate filling of a prescription for
      representation that contact lenses may                       prescriptions to patients.                        contact lenses, including the following:
      be obtained without a prescription. (a)                 315.4 Limits on requiring immediate                       (1) The name of the patient;
      Is this provision sufficiently clear? (b)                    payment.                                             (2) The date of examination;
      What is the impact, including the costs                 315.5 Prescriber verification.                            (3) The issue date and expiration date
      and benefits, of this provision? (c)                    315.6 Expiration of contact lens                       of prescription;
      Should the Commission clarify that this                      prescriptions.                                       (4) The name, postal address,
      provision applies only to contact lenses                315.7 Content of advertisements and other              telephone number, and facsimile
      for which a prescription is required, i.e.,                  representations.                                  telephone number of prescriber;
      that it does not apply to non-corrective                315.8 Prohibition of certain waivers.                     (5) The power, material or
                                                              315.9 Enforcement.                                     manufacturer or both of the prescribed
      or ‘‘cosmetic’’ contact lenses?                         315.10 Severability.
                                                                                                                     contact lens;
      Prohibition of Certain Waivers                            Authority: Pub. L. 108–164, secs. 1–12; 15              (6) The base curve or appropriate
         25. Section 315.8 prohibits prescribers              U.S.C. 7601–7610.                                      designation of the prescribed contact
      from waiving liability or responsibility                § 315.1    Scope of regulations in this part.          lens;
      for the accuracy of the eye examination.                                                                          (7) The diameter, when appropriate,
      (a) Is this provision sufficiently clear?                  This part, which shall be called the                of the prescribed contact lens; and
      (b) What is the impact, including the                   ‘‘Contact Lens Rule,’’ implements the                     (8) In the case of a private label
      costs and benefits, of this provision?                  Fairness to Contact Lens Consumers                     contact lens, the name of the
                                                              Act, codified at 15 U.S.C. 7601–7610,                  manufacturer, trade name of the private
      Enforcement                                             which requires that rules be issued to                 label brand, and, if applicable, trade
        26. Section 315.9 explains how the                    address the release and verification of                name of equivalent brand name.
      Commission will treat violations of the                 contact lens prescriptions. This part                     Direct communication, as used in
      Contact Lens Rule and defines the scope                 specifically governs contact lens                      § 315.5, means completed
      of the agency’s enforcement power and                   prescriptions and related issues. Part                 communication by telephone, facsimile,
      jurisdiction. (a) Is this provision                     456 of Title 16 governs the availability               or electronic mail.
      sufficiently clear? (b) What is the                     of eyeglass prescriptions and related                     Issue date, as used in § 315.6, means
      impact, including the costs and benefits,               issues. 16 CFR part 456 (the Ophthalmic                the date on which the patient receives
      of this provision?                                      Practice Rules (Eyeglass Rule)).                       a copy of the prescription.


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

         Ophthalmic goods are contact lenses,                 sentence, presentation of proof of                     lenses specified on a prescription
      eyeglasses, or any component of                         insurance coverage for that service shall              identical contact lenses that the same
      eyeglasses.                                             be deemed to be a payment.                             company manufactures and sells under
         Ophthalmic services are the                                                                                 different labels.
      measuring, fitting, and adjusting of                    § 315.5    Prescriber Verification                        (f) Recordkeeping requirement. A
      ophthalmic goods subsequent to an eye                      (a) Prescription requirement. A seller              seller shall maintain a record of all
      examination.                                            may sell contact lenses only in                        direct communications referred to in
         Prescriber means, with respect to                    accordance with a contact lens                         paragraph (a) of this section. Such
      contact lens prescriptions, an                          prescription for the patient that is:                  record shall consist of the following:
      ophthalmologist, optometrist, or other                     (1) Presented to the seller by the                     (1) For prescriptions presented to the
      person permitted under State law to                     patient or prescriber directly or by                   seller: the prescription itself, or the
      issue prescriptions for contact lenses in               facsimile; or                                          facsimile version thereof, that was
      compliance with any applicable                             (2) Verified by direct communication.               presented to the seller by the patient or
      requirements established by the Food                       (b) Information for verification. When              prescriber.
      and Drug Administration.                                seeking verification of a contact lens                    (2) For verification requests by the
         Private Label Contact Lenses mean                    prescription, a seller shall provide the               seller:
      contact lenses that are sold under the                  prescriber with the following                             (i) If the communication occurs via
      label of a seller where the contact lenses              information through direct                             facsimile or e-mail, a copy of the
      are identical to lenses made by the same                communication:                                         verification request, including the
      manufacturer but sold under the labels                     (1) The patient’s full name and                     information provided to the prescriber
      of other sellers.                                       address;                                               pursuant to paragraph (b) of this section,
                                                                 (2) The contact lens power,                         and confirmation of the completed
      § 315.3 Availability of Contact Lens                    manufacturer, base curve or appropriate                transmission thereof, including a record
      Prescriptions to Patients                               designation, and diameter when                         of the date and time the request was
         (a) In general. When a prescriber                    appropriate;                                           made.
      completes a contact lens fitting, the                      (3) The quantity of lenses ordered;                    (ii) If the communication occurs via
      prescriber:                                                (4) The date of patient request;                    telephone, a telephone log:
         (1) Whether or not requested by the                     (5) The date and time of verification                  (A) Describing the information
      patient, shall provide to the patient a                 request; and                                           provided pursuant to paragraph (b) of
      copy of the contact lens prescription;                     (6) The name of a contact person at                 this section;
      and                                                     the seller’s company, including                           (B) Setting forth the date and time the
         (2) Shall, as directed by any person                 facsimile and telephone numbers.                       request was made; and
      designated to act on behalf of the                         (c) Verification events. A prescription                (C) Indicating how the call was
      patient, provide or verify the contact                  is verified under paragraph (a)(2) of this             completed.
                                                              section only if one of the following                      (D) The seller also must retain copies
      lens prescription by electronic or other
                                                              occurs:                                                of its telephone bills.
      means.                                                                                                            (3) For communications from the
         (b) Limitations. A prescriber may not:                  (1) The prescriber confirms the
                                                              prescription is accurate by direct                     prescriber, including prescription
         (1) Require the purchase of contact
                                                              communication with the seller;                         verifications:
      lenses from the prescriber or from                                                                                (i) If the communication occurs via
      another person as a condition of                           (2) The prescriber informs the seller
                                                              through direct communication that the                  facsimile or e-mail, a copy of the
      providing a copy of a prescription under                                                                       communication and a record of the time
      paragraph (a)(1) or (a)(2) of this section              prescription is inaccurate and provides
                                                              the accurate prescription; or                          and date it was received.
      or as a condition of verification of a                                                                            (ii) If the communication occurs via
      prescription under paragraph (a)(2) of                     (3) The prescriber fails to
                                                              communicate with the seller within                     telephone, a telephone log describing
      this section;                                                                                                  the information communicated and the
         (2) Require payment in addition to, or               eight (8) business hours after receiving
                                                              from the seller the information                        date and time that the information was
      as part of, the fee for an eye                                                                                 received.
      examination, fitting, and evaluation as a               described in paragraph (b) of this
                                                                                                                        (4) The records required to be
      condition of providing a copy of a                      section.
                                                                                                                     maintained under this section shall be
      prescription under paragraph (a)(1) or                     (d) Invalid prescription. If a prescriber
                                                                                                                     maintained for a period of not less than
      (a) (2) of this section or as a condition               informs a seller before the deadline
                                                                                                                     three years, and these records must be
      of verification of a prescription under                 under paragraph (c)(3) of this section
                                                                                                                     available for inspection by the Federal
      paragraph (a)(2) of this section; or                    that the contact lens prescription is
                                                                                                                     Trade Commission, its employees, and
         (3) Require the patient to sign a                    inaccurate, expired, or otherwise
                                                                                                                     its representatives.
      waiver or release as a condition of                     invalid, the seller shall not fill the
      releasing or verifying a prescription                   prescription. The prescriber shall                     § 315.6 Expiration of contact lens
      under paragraph (a)(1) or (a)(2) of this                specify the basis for the inaccuracy or                prescriptions.
      section.                                                invalidity of the prescription. If the                    (a) In general. A contact lens
                                                              prescription communicated by the seller                prescription shall expire:
      § 315.4 Limits on Requiring Immediate                   to the prescriber is inaccurate, the                      (1) On the date specified by the law
      Payment                                                 prescriber shall correct it, and the                   of the State in which the prescription
        A prescriber may require payment of                   prescription shall then be deemed                      was written, if that date is one year or
      fees for an eye examination, fitting, and               verified under paragraph (c)(2) of this                more after the issue date of the
      evaluation before the release of a contact              section.                                               prescription;
      lens prescription, but only if the                         (e) No alteration of prescription. A                   (2) Not less than one year after the
      prescriber requires immediate payment                   seller may not alter a contact lens                    issue date of the prescription if such
      in the case of an examination that                      prescription. Notwithstanding the                      State law specifies no date or specifies
      reveals no requirement for ophthalmic                   preceding sentence, a seller may                       a date that is less than one year after the
      goods. For purposes of the preceding                    substitute for private label contact                   issue date of the prescription; or


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

         (3) Notwithstanding paragraphs (a)(1)                advertisement, sales presentation, or                  another. If any provision is stayed or
      and (2) of this section, on the date                    otherwise, that contact lenses may be                  determined to be invalid, it is the
      specified by the prescriber, if that date               obtained without a prescription.                       Commission’s intention that the
      is based on the medical judgment of the                                                                        remaining provisions shall continue in
                                                              § 315.8    Prohibition of certain waivers.
      prescriber with respect to the ocular                                                                          effect.
      health of the patient.                                     A prescriber may not place on a
         (b) Special rules for prescriptions of               prescription, or require the patient to                PART 456—AMENDED
      less than one year. (1) If a prescription               sign, or deliver to the patient, a form or
      expires in less than one year, the                      notice waiving or disclaiming the                        2. The authority citation for part 456
      specific reasons for the medical                        liability or responsibility of the                     continues to read as follows:
      judgment referred to in paragraph (a)(3)                prescriber for the accuracy of the eye
                                                              examination. The preceding sentence                      Authority: 15 U.S.C. 57a; 5 U.S.C. 552.
      of this section shall be documented in
      the patient’s medical record with                       does not impose liability on a prescriber
                                                                                                                       3. Revise the title of part 456 to read
                                                              for the ophthalmic goods and services
      sufficient detail to allow for review by                                                                       as follows:
                                                              dispensed by another seller pursuant to
      a qualified professional in the field.
                                                              the prescriber’s correctly verified                    PART 456—OPHTHALMIC PRACTICE
         (2) The documentation described in
                                                              prescription.
      paragraph (b)(1) of this section shall be                                                                      RULES (EYEGLASS RULE)
      maintained for a period of not less than                § 315.9    Enforcement.
      three years, and it must be available for                  Any violation of this part shall be                   4. Add a new § 456.5 to read as
      inspection by the Federal Trade                         treated as a violation of a rule under                 follows:
      Commission, its employees, or its                       section 18 of the Federal Trade                        § 456.5 Rules applicable to prescriptions
      representatives.                                        Commission Act, 15 U.S.C. 57a,                         for contact lenses and related issues.
         (3) No prescriber shall include an                   regarding unfair or deceptive acts or
      expiration date on a prescription that is               practices, and the Commission will                       Rules applicable to prescriptions for
      less than the period of time that he or                 enforce this part in the same manner, by               contact lenses and related issues may be
      she recommends for a reexamination of                   the same means, and with the same                      found at 16 CFR part 315 (Contact Lens
      the patient that is medically necessary.                jurisdiction, powers, and duties as are                Rule).
                                                              available to it pursuant to the Federal                  By direction of the Commission.
      § 315.7 Content of advertisements and
                                                              Trade Commission Act, 15 U.S.C. 41 et
      other representations.                                                                                         Donald S. Clark,
                                                              seq.
        Any person that engages in the                                                                               Secretary.
      manufacture, processing, assembly, sale,                § 315.10    Severability.                              [FR Doc. 04–2235 Filed 2–3–04; 8:45 am]
      offering for sale, or distribution of                     The provisions of this part are                      BILLING CODE 6750–01–P
      contact lenses may not represent, by                    separate and severable from one




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