80 FR 53272 - Contact Lens Rule

FEDERAL TRADE COMMISSION

Federal Register Volume 80, Issue 171 (September 3, 2015)

The Commission is requesting public comments on the Contact Lens Rule, which requires that eyecare prescribers provide a copy of a consumer's prescription to the consumer upon completion of a contact lens fitting and verify or provide prescriptions to authorized third parties. The Rule also mandates that a contact lens seller may sell contact lenses only in accordance with a prescription that the seller either: (a) Has received from the patient or prescriber; or (b) has verified through direct communication with the prescriber. The Commission is soliciting comments about the efficiency, costs, benefits, and regulatory impact of the Rule as part of its systematic review of all current Commission regulations and guides. All interested persons are hereby given notice of the opportunity to submit written data, views, and arguments concerning the Rule.

[Federal Register Volume 80, Number 171 (Thursday, September 3, 2015)]
[Proposed Rules]
[Pages 53272-53274]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21577]


=======================================================================
-----------------------------------------------------------------------

FEDERAL TRADE COMMISSION

16 CFR Part 315


Contact Lens Rule

AGENCY: Federal Trade Commission (``FTC'' or ``Commission'').

ACTION: Request for comment.

-----------------------------------------------------------------------

SUMMARY: The Commission is requesting public comments on the Contact 
Lens Rule, which requires that eyecare prescribers provide a copy of a 
consumer's prescription to the consumer upon completion of a contact 
lens fitting and verify or provide prescriptions to authorized third 
parties. The Rule also mandates that a contact lens seller may sell 
contact lenses only in accordance with a prescription that the seller 
either: (a) Has received from the patient or prescriber; or (b) has 
verified through direct communication with the prescriber. The 
Commission is soliciting comments about the efficiency, costs, 
benefits, and regulatory impact of the Rule as part of its systematic 
review of all current Commission regulations and guides. All interested 
persons are hereby given notice of the opportunity to submit written 
data, views, and arguments concerning the Rule.

DATES: Written comments must be received on or before October 26, 2015.

ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/contactlensrule online or on paper, by 
following the instructions in the Instructions for Submitting Comments 
part of the SUPPLEMENTARY INFORMATION section below. Write ``Contact 
Lens Rule, 16 CFR part 315, Project No. R511995'' on your comment, and 
file your comment online at https://ftcpublic.commentworks.com/ftc/contactlensrule by following the instructions on the web-based form. If 
you prefer to file your comment on paper, write ``Contact Lens Rule, 16 
CFR

[[Page 53273]]

part 315, Project No. R511995'' on your comment and on the envelope and 
mail your comment to the following address: Federal Trade Commission, 
Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 
(Annex C), Washington, DC 20580, or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex 
C), Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT: Alysa Bernstein, Attorney, (202) 326-
3289, or Bonnie McGregor, Federal Trade Investigator, (202) 326-2356, 
Division of Advertising Practices, Bureau of Consumer Protection, 
Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 
20580.

SUPPLEMENTARY INFORMATION: 

I. Background

    In 2003, Congress enacted The Fairness to Contact Lens Consumers 
Act, 15 U.S.C. 7601-7610, and pursuant to the Act, the Commission 
promulgated the Contact Lens Rule on July 2, 2004.\1\ The Rule went 
into effect on August 2, 2004.
---------------------------------------------------------------------------

    \1\ Contact Lens Rule, 16 CFR part 315.
---------------------------------------------------------------------------

    The Contact Lens Rule is intended to facilitate the ability of 
consumers to comparison shop for contact lenses while ensuring that 
contact lenses are sold only in accordance with a valid prescription. 
The Rule requires that eyecare prescribers provide a copy of a 
prescription to the consumer upon completion of a contact lens fitting 
and verify or provide prescriptions to authorized third parties.\2\
---------------------------------------------------------------------------

    \2\ 16 CFR 315.3(a).
---------------------------------------------------------------------------

    The Rule specifies that a prescriber may not require the purchase 
of contact lenses as a condition of providing the prescription or 
verification, may not require payment in addition to, or as a part of, 
the fee for an eye examination, fitting, and evaluation as a condition 
of providing the prescription or verification, and may not require the 
patient to sign a waiver or release as a condition of releasing or 
verifying the prescription.\3\ The prescriber is also prohibited from 
requiring immediate payment before the release of a prescription, 
unless the prescriber requires immediate payment when an exam reveals 
that the consumer does not need ophthalmic goods.\4\
---------------------------------------------------------------------------

    \3\ 16 CFR 315.3(b).
    \4\ 16 CFR 315.4.
---------------------------------------------------------------------------

    The Rule also places certain restrictions on sellers. It mandates 
that sellers sell contact lenses only in accordance with a prescription 
that is either presented to the seller or verified by direct 
communication with the prescriber.\5\ The Rule sets out the information 
that must be included in a seller's verification request, and directs 
that a prescription is only verified under the Rule if: (1) A 
prescriber confirms the prescription is accurate, (2) a prescriber 
informs the seller that the prescription is inaccurate and provides an 
accurate prescription, or (3) if the prescriber fails to communicate 
with the seller within eight business hours after receiving a compliant 
verification request.\6\ The Rule states that if the prescriber informs 
the seller within eight hours of receiving the verification request 
that the prescription is inaccurate, expired, or invalid, the seller 
shall not fill the prescription.\7\
---------------------------------------------------------------------------

    \5\ 16 CFR 315.5(a).
    \6\ 16 CFR 315.5(b)-(c).
    \7\ 16 CFR 315.5(d). If the prescription communicated by the 
seller is inaccurate, the prescriber shall correct it. Id.
---------------------------------------------------------------------------

    Sellers may not alter a prescription, but for private label contact 
lenses, may substitute identical contact lenses that the same company 
manufactures and sells under a different name.\8\ Sellers and others 
involved in the manufacture, assembly, processing and distribution of 
contact lenses are prohibited from representing that contact lenses may 
be obtained without a prescription.\9\
---------------------------------------------------------------------------

    \8\ 16 CFR 315.5(e).
    \9\ 16 CFR 315.7.
---------------------------------------------------------------------------

    The Contact Lens Rule sets a minimum expiration date of one year 
after the issue date of a prescription with an exception based on a 
patient's ocular health.\10\ The Rule also implements the Act by 
providing that ``state and local laws and regulations that establish a 
prescription expiration date of less than one year or that restrict 
prescription release or require active verification are pre-empted.'' 
\11\
---------------------------------------------------------------------------

    \10\ 16 CFR 315.6.
    \11\ 16 CFR 315.11(a). The Rule states further that ``[a]ny 
other state or local laws or regulations that are inconsistent with 
the Act or this part are prempted to the extent of the 
inconsistency.'' 16 CFR 315.11(b).
---------------------------------------------------------------------------

II. Regulatory Review of the Contact Lens Rule

    The Commission periodically reviews all of its rules and guides. 
These reviews seek information about the costs and benefits of the 
agency's rules and guides, and their regulatory and economic impact. 
The information obtained assists the Commission in identifying those 
rules and guides that warrant modification or rescission. Therefore, 
the Commission solicits comments on, among other things, the economic 
impact and benefits of the Rule; possible conflict between the Rule and 
State, local, or other Federal laws or regulations; and the effect on 
the Rule of any technological, economic, or other industry changes 
since the Rule was promulgated.

III. Issues for Comment

    The Commission requests written comment on any or all of the 
following questions. These questions are designed to assist the public 
and should not be construed as a limitation on the issues on which 
public comment may be submitted. The Commission requests that responses 
to its questions be as specific as possible, including a reference to 
the question being answered, and reference to empirical data or other 
evidence upon which comments are based wherever available and 
appropriate.
    1. Is there a continuing need for the Rule? Why or why not?
    2. What benefits has the Rule provided to consumers? What evidence 
supports the asserted benefits?
    3. What modifications, if any, should be made to the Rule to 
increase its benefits to consumers?
    a. What evidence supports the proposed modifications?
    b. How would these modifications affect the costs the Rule imposes 
on businesses, including small businesses?
    c. How would these modifications affect the benefits to consumers?
    4. What impact has the Rule had on the flow of truthful information 
to consumers and on the flow of deceptive information to consumers?
    5. What significant costs, if any, has the Rule imposed on 
consumers? What evidence supports the asserted costs?
    6. What modifications, if any, should be made to the Rule to reduce 
any costs imposed on consumers?
    a. What evidence supports the proposed modifications?
    b. How would these modifications affect the benefits provided by 
the Rule?
    7. What benefits, if any, has the Rule provided to businesses, 
including small businesses? What evidence supports the asserted 
benefits?
    8. What modifications, if any, should be made to the Rule to 
increase its benefits to businesses, including small businesses?
    a. What evidence supports the proposed modifications?
    b. How would these modifications affect the costs the Rule imposes 
on businesses, including small businesses?
    c. How would these modifications affect the benefits to consumers?
    9. What significant costs, if any, including costs of compliance, 
has the Rule imposed on businesses, including small businesses? What 
evidence supports the asserted costs?

[[Page 53274]]

    10. What modifications, if any, should be made to the Rule to 
reduce the costs imposed on businesses, including small businesses?
    a. What evidence supports the proposed modifications?
    b. How would these modifications affect the benefits provided by 
the Rule?
    11. What evidence is available concerning the degree of industry 
compliance with the Rule?
    12. What modifications, if any, should be made to the Rule to 
account for changes in relevant technology or economic conditions? What 
evidence supports the proposed modifications?
    13. Does the Rule overlap or conflict with other federal, state, or 
local laws or regulations? If so, how?
    a. What evidence supports the asserted conflicts?
    b. With reference to the asserted conflicts, should the Rule be 
modified? If so, why, and how? If not, why not?

IV. Instructions for Submitting Comments

    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before October 26, 
2015. Write ``Contact Lens Rule, 16 CFR part 315, Project No. R511995'' 
on the comment. Your comment, including your name and your state, will 
be placed on the public record of this proceeding, including, to the 
extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the 
Commission tries to remove individuals' home contact information from 
comments before placing them on the Commission Web site. Because your 
comment will be made public, you are solely responsible for making sure 
that your comment does not include any sensitive personal information, 
such as a Social Security number, date of birth, driver's license 
number or other state identification number or foreign country 
equivalent, passport number, financial account number, or credit or 
debit card number. You are also solely responsible for making sure that 
your comment does not include any sensitive health information, such as 
medical records or other individually identifiable health information.
    In addition, do not include any ``[t]rade secret or any commercial 
or financial information which is . . . privileged or confidential,'' 
as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC 
Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include 
competitively sensitive information such as costs, sales statistics, 
inventories, formulas, patterns, devices, manufacturing processes, or 
customer names.
    If you want the Commission to give your comment confidential 
treatment, you must file it in paper form, with a request for 
confidential treatment, and you must follow the procedure explained in 
FTC Rule 4.9(c), 16 CFR 4.9(c). In particular, the written request for 
confidential treatment that accompanies the comment must include the 
factual and legal basis for the request, and must identify the specific 
portions of the comments to be withheld from the public record. Your 
comment will be kept confidential only if the FTC General Counsel, in 
his or her sole discretion, grants your request in accordance with the 
law and the public interest.
    Postal mail addressed to the Commission is subject to delay due to 
heightened security screening. As a result, we encourage you to submit 
your comment online. To make sure that the Commission considers your 
online comment, you must file it at https://ftcpublic.commentworks.com/ftc/contactlensrule by following the instructions on the web-based 
form. If this document appears at http://www.regulations.gov/#!home, 
you also may file a comment through that Web site.
    If you file your comment on paper, write ``Contact Lens Rule, 16 
CFR part 315, Project No. R511995'' on your comment and on the 
envelope, and mail your comment to the following address: Federal Trade 
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite 
CC-5610 (Annex C), Washington, DC 20580, or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex 
C), Washington, DC 20024.
    Visit the Commission Web site at http://www.ftc.gov to read this 
document and the news release describing it. The FTC Act and other laws 
that the Commission administers permit the collection of public 
comments to consider and use in this proceeding as appropriate. The 
Commission will consider all timely and responsive public comments that 
it receives on or before October 26, 2015. You can find more 
information, including routine uses permitted by the Privacy Act, in 
the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

    By direction of the Commission.
Donald S. Clark
Secretary.
[FR Doc. 2015-21577 Filed 9-2-15; 8:45 am]
BILLING CODE 6750-01-P