Contact Lens Rule, 53272-53274 [2015-21577]
Download as PDF
<![CDATA[
53272
Federal Register / Vol. 80, No. 171 / Thursday, September 3, 2015 / Proposed Rules
ADAMS Accession Number/Federal Register
Citation/URL
Document
Federal Register notice—PRM–51–29, Commonwealth of Massachusetts, Supplemental Information, December 31, 2012.
Federal Register notice—Revisions to Environmental Review of Renewal of Nuclear Power
Plant Operating Licenses Final Rule, June 20, 2013.
Generic Environmental Impact Statement for License Renewal of Nuclear Plants, NUREG–
1437, Revision 1 (Volumes 1–3), June 21, 2013.
LBP–11–35, Memorandum and Order, denial of waiver in Pilgrim adjudicatory proceeding, December 13, 2011.
NEI 06–12, ‘‘B.5.b Phases 2 & 3 Submittal Guideline, Revision 2,’’ Project 689, December 14,
2006.
NRC Overview of the Structural Integrity of the Spent Fuel Pool at Fukushima Dai-ichi, Unit 4,
April 25, 2014.
NUREG–1353, ‘‘Regulatory Analysis for the Resolution of Generic Issue 82, ‘Beyond Design
Basis Accidents in Spent Fuel Pools,’ ’’ April 30, 1989.
NUREG–1437, ‘‘Generic Environmental Impact Statement for License Renewal of Nuclear
Plants’’ (2013 GEIS), June 20, 2013.
NUREG–1437, ‘‘Generic Environmental Impact Statement for License Renewal of Nuclear
Plants’’ (1996 GEIS; Volumes 1 and 2), May 31, 1996.
NUREG–1738, ‘‘Technical Study of Spent Fuel Pool Accident Risk at Decommissioning Nuclear Power Plants,’’ S102686, February 28, 2001.
NUREG–2157, ‘‘Generic Environmental Impact Statement for Continued Storage of Spent Nuclear Fuel’’.
NUREG–2161, ‘‘Consequence Study of a Beyond-Design-Basis Earthquake Affecting the Spent
Fuel Pool for a U.S. Mark I Boiling-Water Reactor’’ (Spent Fuel Pool Study), October 9, 2013.
Order EA–12–049, NRC Order on Mitigating Strategies, March 12, 2012 ....................................
Order EA–12–051, NRC Order on Spent Fuel Pool Instrumentation, March 12, 2012 .................
Order EA–13–109, NRC Order on Severe Accident Capable Hardened Vents, June 6, 2013 .....
PRM–51–10, Commonwealth of Massachusetts, August 25, 2006 ...............................................
PRM–51–29, from Mathew Brock, Commonwealth Of Mass. Petition for Waiver of C.F.R. Part
51 Subpart A, Appendix B or In Alternative Petition For Rulemaking to Rescind Regulations
Excluding Consideration Of Spent Fuel Storage Impacts, June 2, 2011.
Regulatory Guide 4.2, Supplement 1, Revision 1, ‘‘Preparation of Environmental Reports for
Nuclear Power Plant License Renewal Applications,’’ June 20, 2013.
Report of Japanese Government to the IAEA Ministerial Conference on Nuclear Safety—The
Accident at TEPCO’s Fukushima Nuclear Power Stations, June 2011.
Sandia Letter Report, Revision 2, Mitigation of Spent Fuel Pool Loss-of-Coolant Inventory Accidents And Extension of Reference Plant Analyses to Other Spent Fuel Pools, November 30,
2006.
Sandia Report: MELCOR 1.8.5 Separate Effect Analysis of Spent Fuel Assembly Accident Response, June 30, 2003.
SECY–04–0191, ‘‘Withholding Sensitive Unclassified Information Concerning Nuclear Power
Reactors From Public Disclosure,’’ October 19, 2004.
SECY–11–0125, ‘‘Issuance of Bulletin 2011–01, ‘‘Mitigating Strategies,’’ September 12, 2011 ...
SRM–COMSECY–13–0030, Staff Evaluation and Recommendation for Japan Lessons-Learned
Tier 3 Issue on Expedited Transfer of Spent Fuel, May 23, 2014.
The Thompson Report, ‘‘New And Significant Information From The Fukushima Daiichi Accident In The Context Of Future Operation Of The Pilgrim Nuclear Power Plant,’’ June 1, 2011.
Dated at Rockville, Maryland, this 25th day
of August, 2015.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2015–21834 Filed 9–2–15; 8:45 am]
BILLING CODE 7590–01–P
FEDERAL TRADE COMMISSION
rmajette on DSK7SPTVN1PROD with PROPOSALS
16 CFR Part 315
Contact Lens Rule
Federal Trade Commission
(‘‘FTC’’ or ‘‘Commission’’).
ACTION: Request for comment.
AGENCY:
The Commission is requesting
public comments on the Contact Lens
SUMMARY:
VerDate Sep<11>2014
13:54 Sep 02, 2015
Jkt 235001
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
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
77 FR 76952.
78 FR 37282.
ML13107A023.
ML11332A152.
ML070090060.
ML14111A099.
ML082330232.
ML13107A023.
ML040690705, ML040690738.
ML010430066.
ML14196A105, ML14196A107.
ML14255A365.
ML12054A735.
ML12056A044.
ML13143A321.
ML062640409.
ML12254A005.
ML13067A354.
https://www.kantei.go.jp/foreign/kan/topics/
201106/iaea_houkokusho_e.html.
ML120970086.
ML062290362.
ML042310663.
ML111250360.
ML14143A360.
ML12094A183.
written data, views, and arguments
concerning the Rule.
Written comments must be
received on or before October 26, 2015.
DATES:
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
ADDRESSES:
E:\FR\FM\03SEP1.SGM
03SEP1
Federal Register / Vol. 80, No. 171 / Thursday, September 3, 2015 / Proposed Rules
rmajette on DSK7SPTVN1PROD with PROPOSALS
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.
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
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
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
1 Contact
Lens Rule, 16 CFR part 315.
CFR 315.3(a).
3 16 CFR 315.3(b).
4 16 CFR 315.4.
2 16
VerDate Sep<11>2014
13:54 Sep 02, 2015
Jkt 235001
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
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
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
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
5 16
CFR 315.5(a).
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.
8 16 CFR 315.5(e).
9 16 CFR 315.7.
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).
6 16
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
53273
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?
E:\FR\FM\03SEP1.SGM
03SEP1
53274
Federal Register / Vol. 80, No. 171 / Thursday, September 3, 2015 / Proposed Rules
rmajette on DSK7SPTVN1PROD with PROPOSALS
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 https://
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,
VerDate Sep<11>2014
13:54 Sep 02, 2015
Jkt 235001
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 https://
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
https://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 https://www.ftc.gov/
ftc/privacy.htm.
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
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
FEDERAL TRADE COMMISSION
16 CFR Part 456
Ophthalmic Practice Rules (Eyeglass
Rule)
Federal Trade Commission
(‘‘FTC’’ or ‘‘Commission’’).
ACTION: Advance notice of proposed
rulemaking; request for comment.
AGENCY:
The Commission is requesting
public comment on its Trade Regulation
Rule entitled ‘‘Ophthalmic Practice
Rules (Eyeglass Rule),’’ which requires
eye care practitioners to release eyeglass
prescriptions to their patients (‘‘Eyeglass
Rule’’). 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/
ophthalmicruleanprm online or on
paper, by following the instructions in
the Instructions for Submitting
Comments part of the SUPPLEMENTARY
INFORMATION section below. Write
‘‘Eyeglass Rule, 16 CFR part 456, Project
No. R511996’’ on your comment, and
file your comment online at https://
ftcpublic.commentworks.com/ftc/
ophthalmicruleanprm by following the
instructions on the web-based form. If
you prefer to file your comment on
paper, write ‘‘Eyeglass Rule, 16 CFR part
456, Project No. R51199’’ 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 B),
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 B), 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,
SUMMARY:
E:\FR\FM\03SEP1.SGM
03SEP1
]]>Agencies
[Federal Register Volume 80, Number 171 (Thursday, September 3, 2015)]
[Proposed Rules]
[Pages 53272-53274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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 https://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 https://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 https://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
