Agency Information Collection Activities; Proposed Collection; Comment Request, 31938-31941 [2016-11952]
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Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices
The CSRIC is a Federal Advisory
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Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. 2016–11920 Filed 5–19–16; 8:45 am]
BILLING CODE 6712–01–P
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FEDERAL DEPOSIT INSURANCE
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Notice to All Interested Parties of the
Termination of the Receivership of
10006, First Integrity Bank, National
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Notice is hereby given that the Federal
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Minnesota (‘‘the Receiver’’) intends to
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this time frame.
Dated: May 17, 2016.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2016–11996 Filed 5–19–16; 8:45 am]
BILLING CODE 6714–01–P
FEDERAL RESERVE SYSTEM
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
The notificants listed below have
applied under the Change in Bank
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§ 225.41 of the Board’s Regulation Y (12
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2016.
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A. Federal Reserve Bank of Kansas
City (Dennis Denney, Assistant Vice
President) 1 Memorial Drive, Kansas
City, Missouri 64198–0001:
1. Sam Charles Brown and Josephine
Marie Brown, Pueblo, Colorado; to
retain voting shares and thereby control
of Pueblo Bancorporation, parent of
Pueblo Bank & Trust Company, both of
Pueblo, Colorado. In addition, Michelle
Rene Brown, Kenneth Scott Brown,
Karla Lynn Brown, and Sam Charles
Brown, III, all of Pueblo, Colorado,
request approval to retain shares of
Pueblo Bancorp and for approval as
members of the Brown Family Group,
which acting in concert controls Pueblo
Bancorp.
Board of Governors of the Federal Reserve
System, May 13, 2016.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2016–11863 Filed 5–19–16; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL TRADE COMMISSION
Agency Information Collection
Activities; Proposed Collection;
Comment Request
Federal Trade Commission
(FTC or Commission).
ACTION: Notice.
AGENCY:
The information collection
requirements described below will be
submitted to the Office of Management
and Budget (OMB) for review, as
required by the Paperwork Reduction
Act (PRA). The FTC seeks public
comments on its proposal to extend, for
three years, the current PRA clearance
for information collection requirements
contained in the Contact Lens Rule.
This clearance expires on September 30,
2016.
DATES: Comments must be received on
or before July 19, 2016.
ADDRESSES: Interested parties may file a
comment online or on paper by
following the instructions in the
Request for Comments part of the
SUPPLEMENTARY INFORMATION section
below. Write ‘‘Contact Lens Rule: FTC
File No. P054510’’ on your comment,
and file your comment online at https://
ftcpublic.commentworks.com/ftc/
contactlensrulepra by following the
instructions on the web-based form. If
you prefer to file your comment on
paper, mail or deliver your comment to
the following address: Federal Trade
Commission, Office of the Secretary,
600 Pennsylvania Avenue NW., Suite
CC–5610 (Annex J), Washington, DC
20580, or deliver your comment to the
SUMMARY:
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Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices
following address: Federal Trade
Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW.,
5th Floor, Suite 5610 (Annex J),
Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT:
Requests for copies of the collection of
information and supporting
documentation should be addressed to
Alysa S. Bernstein, Attorney, Division of
Advertising Practices, Bureau of
Consumer Protection, Federal Trade
Commission, 600 Pennsylvania Avenue
NW., Mail Drop CC–10528, Washington,
DC 20580, at (202) 326–3289.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act (‘‘PRA’’), 44
U.S.C. 3501–3520, federal agencies must
get OMB approval for each collection of
information they conduct, sponsor, or
require. ‘‘Collection of information’’
means agency requests or requirements
to submit reports, keep records, or
provide information to a third party. 44
U.S.C. 3502(3); 5 CFR 1320.3(c). As
required by section 3506(c)(2)(A) of the
PRA, the FTC is providing this
opportunity for public comment before
requesting that OMB extend the existing
PRA clearance for the information
collection requirements associated with
the Commission’s rules and regulations
under the Contact Lens Rule, 16 CFR
part 315 (OMB Control Number 3084–
0127).
The FTC invites comments on: (1)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(2) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on those who are to respond. All
comments must be received on or before
July 19, 2016.
The Rule was promulgated by the FTC
pursuant to the Fairness to Contact Lens
Consumers Act (FCLCA), Public Law
108–164 (Dec. 6, 2003), which was
enacted to enable consumers to
purchase contact lenses from the seller
of their choice. The Rule became
effective on August 2, 2004. As
mandated by the FCLCA, the Rule
requires the release and verification of
contact lens prescriptions and contains
recordkeeping requirements applying to
both prescribers and sellers of contact
lenses.
Specifically, the Rule requires that
prescribers provide a copy of the
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prescription to the consumer upon the
completion of a contact lens fitting,
even if the patient does not request it,
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. In addition, the Rule
imposes recordkeeping requirements on
contact lens prescribers and sellers. For
example, the Rule requires prescribers
to document in their patients’ records
the medical reasons for setting a contact
lens prescription expiration date of less
than one year. The Rule requires contact
lens sellers to maintain records for three
years of all direct communications
involved in obtaining verification of a
contact lens prescription, as well as
prescriptions, or copies thereof, which
they receive directly from customers or
prescribers.
The information retained under the
Rule’s recordkeeping requirements is
used by the Commission to substantiate
compliance with the Rule and may also
provide a basis for the Commission to
bring an enforcement action. Without
the required records, it would be
difficult either to ensure that entities are
complying with the Rule’s requirements
or to bring enforcement actions based on
violations of the Rule.
No substantive provisions in the Rule
have been amended or changed since
staff’s prior submission to OMB.1 Thus,
the Rule’s disclosure and recordkeeping
requirements remain the same.
Estimated total annual hours burden:
Approximately 1,796,764 hours.
This figure is derived by adding
843,159 disclosure hours for contact
lens prescribers to 953,605
recordkeeping hours for contact lens
sellers, for a combined industry total of
1,796,764 hours. This is higher than
estimates submitted to OMB in 2013
(the respective figure was 1,594,981
hours in July 2013). The higher estimate
is due to an increase in the estimated
number of contact lens wearers from 38
million (2012) to 41 million (2015), and
an increase in the estimated percentage
of verification requests that require the
prescribers to make an affirmative
response.
1. Prescribers
The Rule requires prescribers to make
disclosures in two ways. Upon
completing a contact lens fitting, the
1 The FTC most recently submitted clearance
three years ago. 78 FR 9391 (Feb. 8, 2013) and 78
FR 44122 (Jul. 23, 2013).
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Rule requires that prescribers (1)
provide a copy of the contact lens
prescription to the patient, and (2) as
directed by any person designated to act
on behalf of the patient, provide or
verify the contact lens prescription.
Prescribers can verify a prescription
either by responding affirmatively to a
request for verification, or by not
responding at all, in which case the
prescription will be ‘‘passively verified’’
after eight business hours. Prescribers
are also required to correct an incorrect
prescription submitted by a seller, and
notify a seller if the prescription
submitted for verification is expired or
otherwise invalid.2 Staff believes that
the burden of complying with these
requirements is relatively low.
As noted above, the number of contact
lens wearers in the United States is
estimated to be approximately 41
million.3 Therefore, assuming an annual
contact lens exam for each contact lens
wearer, approximately 41 million
people would receive a copy of their
prescription each year under the Rule.4
At an estimated one minute per
prescription,5 the annual time spent by
prescribers complying with the
requirement to release prescriptions to
patients would be approximately
683,333 hours. [(41 million × 1 minute)/
60 minutes = 683,333 hours]. This
estimate likely overstates the actual
burden because it includes the time
spent by prescribers who already release
prescriptions to patients in the ordinary
course of business.
As stated above, prescribers may also
be required to provide or verify contact
lens prescriptions to sellers. According
to recent survey data, approximately
35.6% of contact lens purchases are
from a source other than the prescriber.6
2 16
CFR 315.5.
J. Nichols, 2015 Annual Report: Contact
Lenses 2015, Contact Lens Spectrum, Vol. 31, Jan.
2016, pp. 18–23, 18.
4 In the past, some commentators have suggested
that typical contact lens wearers obtain annual
exams every 18 months or so, not every year.
However, because most prescriptions are valid a
minimum of one year under the Rule, and use of
a longer exam cycle would lead to an estimate of
a lower number of exams and a reduced burden, we
continue to estimate that patients seek exams every
12 months.
5 In the past, some commenters have suggested
that prescribers spend three to five minutes
providing a prescription to each patient. However,
the Paperwork Reduction Act defines ‘‘burden’’ in
such a way that it excludes any effort that would
be expended regardless of a regulatory requirement.
5 CFR 1320.3(b)(2). In most instances, an eye care
professional would already spend time inputting
the prescription into the patient’s file regardless of
the Rule, and the extra burden imposed by the Rule
is merely copying that prescription for the patient,
which we estimate at one minute.
6 VisionWatch Eyewear U.S. Study, The Vision
Council, Contact Lenses, December 2015, 11A.
3 Jason
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Assuming that each of the 41 million
contact lens wearers in the U.S. makes
one purchase per year, this means that
approximately 14,596,000 contact lens
purchases (41 million × 35.6%) are
made from sellers other than the
prescriber.
Based on recent discussions with
industry, approximately 73% of sales by
non-prescriber sellers require
verification, and prescribers
affirmatively respond (by notifying the
seller that the prescription is invalid or
incorrect) to approximately 15% of
those verification requests. Using a
response rate of 15%, the FTC therefore
estimates that prescribers’ offices
respond to approximately 1,598,262
verification requests annually.
[(14,596,000 × 73%) × 15% = 1,598,262
responses]. Additionally, some
prescribers may voluntarily respond to
verification requests and confirm
prescriptions (as opposed to simply
letting the prescription passively verify).
Because correcting or declining
incorrect prescriptions is mandated by
the Rule and occurs in response to
approximately 15% of requests, staff
assumes that prescribers voluntarily
confirm prescriptions less often, and
confirm no more than an additional
15% of prescriptions. Using a combined
response rate of 30%, the FTC estimates
that prescribers’ offices respond to
approximately 3,196,524 requests
annually.
We estimate that responding to
verification requests requires three
minutes per request.7 Using that data,
we estimate that these responses require
an additional 159,826 hours annually.
[(3,196,524 × 3 minutes)/60 minutes =
159,826 hours].
Combining these hours with the hours
spent disclosing prescriptions to
consumers, we estimate a total of
843,159 hours for contact lens
prescribers. [683,333 + 159,826 hours =
843,159 hours].
Lastly, as required by the FCLCA, the
Rule also imposes a recordkeeping
requirement on prescribers. They must
document the specific medical reasons
for setting a contact lens prescription
expiration date shorter than the oneyear minimum established by the
FCLCA. This burden is likely to be nil
because the requirement applies only in
cases when the prescriber invokes the
medical judgment exception, which is
expected to occur infrequently, and
prescribers are likely to record this
information in the ordinary course of
7 This
estimate is based on the Comment of Roger
Jordan of the American Optometric Association,
April 9, 2013, at 2, available on the FTC’s Web site
at https://www.ftc.gov/policy/public-comments/
initiative-479.
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business as part of their patients’
medical records. As mentioned
previously, the OMB regulation that
implements the PRA defines ‘‘burden’’
to exclude any effort that would be
expended regardless of a regulatory
requirement.8
2. Sellers
As noted above, a seller may sell
contact lenses only in accordance with
a valid prescription that the seller (a)
has received from the patient or
prescriber, or (b) has verified through
direct communication with the
prescriber. The FCLCA also requires
sellers to retain prescriptions and
records of communications with
prescribers relating to prescription
verification for three years. Staff
believes that the burden of complying
with these requirements is relatively
low.
As stated previously, there are
approximately 14,596,000 sales by nonprescriber sellers annually and
approximately 73% of those sales
require verification. Therefore, sellers
verify approximately 10,655,080 orders
annually and retain two records for such
sales: The verification request and any
response from the prescriber. Staff
estimates that sellers’ verification and
recordkeeping for those orders will
entail a maximum of five minutes per
sale. At an estimated five minutes per
sale to each of the approximately
10,655,080 orders, contact lens sellers
will spend a total of 887,923 burden
hours complying with this portion of
the requirement. [(10,655,080 orders × 5
minutes)/60 minutes = 887,923 hours].
This means that approximately 27%
of the remaining sales to non-prescriber
sellers do not require verification and
require the seller to keep only the
prescription provided. Staff estimates
that this recordkeeping burden requires
at most one minute per order for
3,940,920 orders, resulting in 65,682
burden hours. [(3,940,920 orders × 1
minute)/60 minutes = 65,682 hours].
Combining burden hours for all
orders, staff estimates a total of 953,605
hours for contact lens sellers. This
estimate likely overstates the actual
burden because it includes the time
spent by sellers who already keep
records pertaining to contact lens sales
in the ordinary course of business. In
addition, the estimate may overstate the
time spent by sellers to the extent that
records (e.g., verification requests) are
generated and stored automatically and
electronically, which staff understands
is the case for some online sellers.
85
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CFR 1320.3(b)(2).
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Estimated total labor cost burden:
Approximately $61,540,563.
Commission staff derived labor costs
by applying appropriate hourly cost
figures to the burden hours described
above. Based on information from the
industry, staff estimates that
optometrists account for approximately
85% of prescribers. Consequently, for
simplicity, staff will focus on their
average hourly wage in estimating
prescribers’ labor cost burden.
According to Bureau of Labor
Statistics, salaried optometrists earn an
average wage of $55.65 per hour and
general office clerks earn an average
wage of $15.33 per hour.9
Assuming that optometrists are
performing the brunt of the labor for
prescribers and office clerks are
performing the labor for non-prescriber
sellers, estimated total labor cost
attributable to the Rule would be
approximately $61,254,481. [($55.65 ×
843,159 prescriber hours = 46,921,798)
+ ($15.33 × 953,605 office clerk hours =
14,618,765) = $61,540,563].
The contact lens market is a
multibillion-dollar market. One survey
estimates that contact lens sales in the
U.S. in 2015 totaled $4,664,200,000 at
the retail level.10 The total labor cost
burden estimate of $61,540,563
represents approximately 1.3% of the
overall retail market.
Request for Comments:
You can file a comment online or on
paper. Write ‘‘Contact Lens Rule: FTC
File No. P054510’’ on your 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
9 Press Release, Bureau of Labor Statistics, United
States Department of Labor, Occupational
Employment Statistics—May, 2015, available at
https://www.bls.gov/news.release/ocwage.t01.htm.
10 The Vision Council, US Optical Industry
Report Card, December 2015.
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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). 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, the
Commission encourages you to submit
your comments online. To make sure
that the Commission considers your
online comment, you must file it at
https://ftcpublic.commentworks.com/
ftc/contactlensrulepra by following the
instructions on the Web-based form. If
this Notice appears at https://
www.regulations.gov, you also may file
a comment through that Web site.
If you file your comment on paper,
write ‘‘Contact Lens Rule: FTC File No.
P054510’’ on your comment and on the
envelope, and mail it to the following
address: Federal Trade Commission,
Office of the Secretary, 600
Pennsylvania Avenue NW., Suite CC–
5610, (Annex J), 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 J),
Washington, DC 20024. If possible,
submit your paper comment to the
Commission by courier or overnight
service.
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 July 19, 2016. You can find more
information, including routine uses
permitted by the Privacy Act, in the
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31941
Commission’s privacy policy, at https://
www.ftc.gov/ftc/privacy.htm.
AmbulatoryPaymentClassification
Groups.html.
David C. Shonka,
Acting General Counsel.
Deadlines
[FR Doc. 2016–11952 Filed 5–19–16; 8:45 am]
Deadline for Presentations and
Comments
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1665–N]
Medicare Program; Announcement of
the Advisory Panel on Hospital
Outpatient Payment (the Panel)
Meeting on August 22–23, 2016 and
Announcement of Transition to One
Meeting of the Panel Per Year
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
This notice announces the
summer meeting of the Advisory Panel
on Hospital Outpatient Payment (the
Panel) for 2016. It also announces that
the Panel will begin meeting once a year
in the summer, beginning in Calendar
Year 2017. Currently, the Panel
convenes twice yearly. The purpose of
the Panel is to advise the Secretary of
the Department of Health and Human
Services (DHHS) (the Secretary) and the
Administrator of the Centers for
Medicare & Medicaid Services (CMS)
(the Administrator) on the clinical
integrity of the Ambulatory Payment
Classification (APC) groups and their
associated weights and hospital
outpatient therapeutic services
supervision issues.
DATES: Meeting Dates: The second semiannual meeting in 2016 is scheduled for
the following dates and times. The times
listed in this notice are Eastern Daylight
Time (EDT) and are approximate times;
consequently, the meetings may last
longer or be shorter than the times listed
in this notice, but will not begin before
the posted times:
• Monday, August 22, 2016, 9 a.m. to
5 p.m. EDT.
• Tuesday, August 23, 2016, 9 a.m. to
5 p.m. EDT.
Meeting Information Updates: The
actual meeting hours and days will be
posted in the agenda. As information
and updates regarding the onsite,
webcast and teleconference meeting,
and agenda become available, they will
be posted to the CMS Web site at: https://
cms.gov/Regulations-and-Guidance/
Guidance/FACA/AdvisoryPanelon
SUMMARY:
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Presentations or comments and form
CMS–20017, (located at https://www.
cms.hhs.gov/cmsforms/downloads/
cms20017.pdf) must be received by 5
p.m. EDT, Friday, July 15, 2016.
Presentations and comments that are not
received by the due date and time will
be considered late and will not be
included on the agenda. In commenting,
please refer to file code CMS–1665–N.
Meeting Registration Timeframe:
Monday, June 27, 2016, through Friday,
July 29, 2016 at 5 p.m. EDT.
Participants planning to attend this
meeting in person must register online,
during the above specified timeframe at:
https://www.cms.gov/apps/events/
default.asp. On this Web page, double
click the ‘‘Upcoming Events’’ hyperlink,
and then double click the ‘‘HOP Panel’’
event title link and enter the required
information. Include any requests for
special accommodations.
Note: Participants who do not plan to
attend the meeting in person should not
register. No registration is required for
participants who plan to view the meeting
via webcast.
Because of staff and resource
limitations, we cannot accept comments
and presentations by facsimile (FAX)
transmission.
Meeting Location, Webcast, and
Teleconference
The meeting will be held in the
Auditorium, CMS Central Office, 7500
Security Boulevard, Woodlawn,
Maryland 21244–1850. Alternately, the
public may either view this meeting via
a webcast or listen by teleconference.
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E:\FR\FM\20MYN1.SGM
20MYN1
Agencies
[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31938-31941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11952]
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FEDERAL TRADE COMMISSION
Agency Information Collection Activities; Proposed Collection;
Comment Request
AGENCY: Federal Trade Commission (FTC or Commission).
ACTION: Notice.
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SUMMARY: The information collection requirements described below will
be submitted to the Office of Management and Budget (OMB) for review,
as required by the Paperwork Reduction Act (PRA). The FTC seeks public
comments on its proposal to extend, for three years, the current PRA
clearance for information collection requirements contained in the
Contact Lens Rule. This clearance expires on September 30, 2016.
DATES: Comments must be received on or before July 19, 2016.
ADDRESSES: Interested parties may file a comment online or on paper by
following the instructions in the Request for Comments part of the
SUPPLEMENTARY INFORMATION section below. Write ``Contact Lens Rule: FTC
File No. P054510'' on your comment, and file your comment online at
https://ftcpublic.commentworks.com/ftc/contactlensrulepra by following
the instructions on the web-based form. If you prefer to file your
comment on paper, mail or deliver your comment to the following
address: Federal Trade Commission, Office of the Secretary, 600
Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580,
or deliver your comment to the
[[Page 31939]]
following address: Federal Trade Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex
J), Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT: Requests for copies of the collection
of information and supporting documentation should be addressed to
Alysa S. Bernstein, Attorney, Division of Advertising Practices, Bureau
of Consumer Protection, Federal Trade Commission, 600 Pennsylvania
Avenue NW., Mail Drop CC-10528, Washington, DC 20580, at (202) 326-
3289.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act (``PRA''),
44 U.S.C. 3501-3520, federal agencies must get OMB approval for each
collection of information they conduct, sponsor, or require.
``Collection of information'' means agency requests or requirements to
submit reports, keep records, or provide information to a third party.
44 U.S.C. 3502(3); 5 CFR 1320.3(c). As required by section
3506(c)(2)(A) of the PRA, the FTC is providing this opportunity for
public comment before requesting that OMB extend the existing PRA
clearance for the information collection requirements associated with
the Commission's rules and regulations under the Contact Lens Rule, 16
CFR part 315 (OMB Control Number 3084-0127).
The FTC invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on those who
are to respond. All comments must be received on or before July 19,
2016.
The Rule was promulgated by the FTC pursuant to the Fairness to
Contact Lens Consumers Act (FCLCA), Public Law 108-164 (Dec. 6, 2003),
which was enacted to enable consumers to purchase contact lenses from
the seller of their choice. The Rule became effective on August 2,
2004. As mandated by the FCLCA, the Rule requires the release and
verification of contact lens prescriptions and contains recordkeeping
requirements applying to both prescribers and sellers of contact
lenses.
Specifically, the Rule requires that prescribers provide a copy of
the prescription to the consumer upon the completion of a contact lens
fitting, even if the patient does not request it, 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. In addition, the Rule imposes recordkeeping
requirements on contact lens prescribers and sellers. For example, the
Rule requires prescribers to document in their patients' records the
medical reasons for setting a contact lens prescription expiration date
of less than one year. The Rule requires contact lens sellers to
maintain records for three years of all direct communications involved
in obtaining verification of a contact lens prescription, as well as
prescriptions, or copies thereof, which they receive directly from
customers or prescribers.
The information retained under the Rule's recordkeeping
requirements is used by the Commission to substantiate compliance with
the Rule and may also provide a basis for the Commission to bring an
enforcement action. Without the required records, it would be difficult
either to ensure that entities are complying with the Rule's
requirements or to bring enforcement actions based on violations of the
Rule.
No substantive provisions in the Rule have been amended or changed
since staff's prior submission to OMB.\1\ Thus, the Rule's disclosure
and recordkeeping requirements remain the same.
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\1\ The FTC most recently submitted clearance three years ago.
78 FR 9391 (Feb. 8, 2013) and 78 FR 44122 (Jul. 23, 2013).
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Estimated total annual hours burden: Approximately 1,796,764 hours.
This figure is derived by adding 843,159 disclosure hours for
contact lens prescribers to 953,605 recordkeeping hours for contact
lens sellers, for a combined industry total of 1,796,764 hours. This is
higher than estimates submitted to OMB in 2013 (the respective figure
was 1,594,981 hours in July 2013). The higher estimate is due to an
increase in the estimated number of contact lens wearers from 38
million (2012) to 41 million (2015), and an increase in the estimated
percentage of verification requests that require the prescribers to
make an affirmative response.
1. Prescribers
The Rule requires prescribers to make disclosures in two ways. Upon
completing a contact lens fitting, the Rule requires that prescribers
(1) provide a copy of the contact lens prescription to the patient, and
(2) as directed by any person designated to act on behalf of the
patient, provide or verify the contact lens prescription. Prescribers
can verify a prescription either by responding affirmatively to a
request for verification, or by not responding at all, in which case
the prescription will be ``passively verified'' after eight business
hours. Prescribers are also required to correct an incorrect
prescription submitted by a seller, and notify a seller if the
prescription submitted for verification is expired or otherwise
invalid.\2\ Staff believes that the burden of complying with these
requirements is relatively low.
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\2\ 16 CFR 315.5.
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As noted above, the number of contact lens wearers in the United
States is estimated to be approximately 41 million.\3\ Therefore,
assuming an annual contact lens exam for each contact lens wearer,
approximately 41 million people would receive a copy of their
prescription each year under the Rule.\4\
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\3\ Jason J. Nichols, 2015 Annual Report: Contact Lenses 2015,
Contact Lens Spectrum, Vol. 31, Jan. 2016, pp. 18-23, 18.
\4\ In the past, some commentators have suggested that typical
contact lens wearers obtain annual exams every 18 months or so, not
every year. However, because most prescriptions are valid a minimum
of one year under the Rule, and use of a longer exam cycle would
lead to an estimate of a lower number of exams and a reduced burden,
we continue to estimate that patients seek exams every 12 months.
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At an estimated one minute per prescription,\5\ the annual time
spent by prescribers complying with the requirement to release
prescriptions to patients would be approximately 683,333 hours. [(41
million x 1 minute)/60 minutes = 683,333 hours]. This estimate likely
overstates the actual burden because it includes the time spent by
prescribers who already release prescriptions to patients in the
ordinary course of business.
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\5\ In the past, some commenters have suggested that prescribers
spend three to five minutes providing a prescription to each
patient. However, the Paperwork Reduction Act defines ``burden'' in
such a way that it excludes any effort that would be expended
regardless of a regulatory requirement. 5 CFR 1320.3(b)(2). In most
instances, an eye care professional would already spend time
inputting the prescription into the patient's file regardless of the
Rule, and the extra burden imposed by the Rule is merely copying
that prescription for the patient, which we estimate at one minute.
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As stated above, prescribers may also be required to provide or
verify contact lens prescriptions to sellers. According to recent
survey data, approximately 35.6% of contact lens purchases are from a
source other than the prescriber.\6\
[[Page 31940]]
Assuming that each of the 41 million contact lens wearers in the U.S.
makes one purchase per year, this means that approximately 14,596,000
contact lens purchases (41 million x 35.6%) are made from sellers other
than the prescriber.
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\6\ VisionWatch Eyewear U.S. Study, The Vision Council, Contact
Lenses, December 2015, 11A.
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Based on recent discussions with industry, approximately 73% of
sales by non-prescriber sellers require verification, and prescribers
affirmatively respond (by notifying the seller that the prescription is
invalid or incorrect) to approximately 15% of those verification
requests. Using a response rate of 15%, the FTC therefore estimates
that prescribers' offices respond to approximately 1,598,262
verification requests annually. [(14,596,000 x 73%) x 15% = 1,598,262
responses]. Additionally, some prescribers may voluntarily respond to
verification requests and confirm prescriptions (as opposed to simply
letting the prescription passively verify). Because correcting or
declining incorrect prescriptions is mandated by the Rule and occurs in
response to approximately 15% of requests, staff assumes that
prescribers voluntarily confirm prescriptions less often, and confirm
no more than an additional 15% of prescriptions. Using a combined
response rate of 30%, the FTC estimates that prescribers' offices
respond to approximately 3,196,524 requests annually.
We estimate that responding to verification requests requires three
minutes per request.\7\ Using that data, we estimate that these
responses require an additional 159,826 hours annually. [(3,196,524 x 3
minutes)/60 minutes = 159,826 hours].
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\7\ This estimate is based on the Comment of Roger Jordan of the
American Optometric Association, April 9, 2013, at 2, available on
the FTC's Web site at https://www.ftc.gov/policy/public-comments/initiative-479.
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Combining these hours with the hours spent disclosing prescriptions
to consumers, we estimate a total of 843,159 hours for contact lens
prescribers. [683,333 + 159,826 hours = 843,159 hours].
Lastly, as required by the FCLCA, the Rule also imposes a
recordkeeping requirement on prescribers. They must document the
specific medical reasons for setting a contact lens prescription
expiration date shorter than the one-year minimum established by the
FCLCA. This burden is likely to be nil because the requirement applies
only in cases when the prescriber invokes the medical judgment
exception, which is expected to occur infrequently, and prescribers are
likely to record this information in the ordinary course of business as
part of their patients' medical records. As mentioned previously, the
OMB regulation that implements the PRA defines ``burden'' to exclude
any effort that would be expended regardless of a regulatory
requirement.\8\
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\8\ 5 CFR 1320.3(b)(2).
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2. Sellers
As noted above, a seller may sell contact lenses only in accordance
with a valid prescription that the seller (a) has received from the
patient or prescriber, or (b) has verified through direct communication
with the prescriber. The FCLCA also requires sellers to retain
prescriptions and records of communications with prescribers relating
to prescription verification for three years. Staff believes that the
burden of complying with these requirements is relatively low.
As stated previously, there are approximately 14,596,000 sales by
non-prescriber sellers annually and approximately 73% of those sales
require verification. Therefore, sellers verify approximately
10,655,080 orders annually and retain two records for such sales: The
verification request and any response from the prescriber. Staff
estimates that sellers' verification and recordkeeping for those orders
will entail a maximum of five minutes per sale. At an estimated five
minutes per sale to each of the approximately 10,655,080 orders,
contact lens sellers will spend a total of 887,923 burden hours
complying with this portion of the requirement. [(10,655,080 orders x 5
minutes)/60 minutes = 887,923 hours].
This means that approximately 27% of the remaining sales to non-
prescriber sellers do not require verification and require the seller
to keep only the prescription provided. Staff estimates that this
recordkeeping burden requires at most one minute per order for
3,940,920 orders, resulting in 65,682 burden hours. [(3,940,920 orders
x 1 minute)/60 minutes = 65,682 hours].
Combining burden hours for all orders, staff estimates a total of
953,605 hours for contact lens sellers. This estimate likely overstates
the actual burden because it includes the time spent by sellers who
already keep records pertaining to contact lens sales in the ordinary
course of business. In addition, the estimate may overstate the time
spent by sellers to the extent that records (e.g., verification
requests) are generated and stored automatically and electronically,
which staff understands is the case for some online sellers.
Estimated total labor cost burden: Approximately $61,540,563.
Commission staff derived labor costs by applying appropriate hourly
cost figures to the burden hours described above. Based on information
from the industry, staff estimates that optometrists account for
approximately 85% of prescribers. Consequently, for simplicity, staff
will focus on their average hourly wage in estimating prescribers'
labor cost burden.
According to Bureau of Labor Statistics, salaried optometrists earn
an average wage of $55.65 per hour and general office clerks earn an
average wage of $15.33 per hour.\9\
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\9\ Press Release, Bureau of Labor Statistics, United States
Department of Labor, Occupational Employment Statistics--May, 2015,
available at https://www.bls.gov/news.release/ocwage.t01.htm.
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Assuming that optometrists are performing the brunt of the labor
for prescribers and office clerks are performing the labor for non-
prescriber sellers, estimated total labor cost attributable to the Rule
would be approximately $61,254,481. [($55.65 x 843,159 prescriber hours
= 46,921,798) + ($15.33 x 953,605 office clerk hours = 14,618,765) =
$61,540,563].
The contact lens market is a multibillion-dollar market. One survey
estimates that contact lens sales in the U.S. in 2015 totaled
$4,664,200,000 at the retail level.\10\ The total labor cost burden
estimate of $61,540,563 represents approximately 1.3% of the overall
retail market.
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\10\ The Vision Council, US Optical Industry Report Card,
December 2015.
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Request for Comments:
You can file a comment online or on paper. Write ``Contact Lens
Rule: FTC File No. P054510'' on your 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
[[Page 31941]]
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). 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, the Commission encourages you to
submit your comments online. To make sure that the Commission considers
your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/contactlensrulepra by following the
instructions on the Web-based form. If this Notice appears at https://www.regulations.gov, you also may file a comment through that Web site.
If you file your comment on paper, write ``Contact Lens Rule: FTC
File No. P054510'' on your comment and on the envelope, and mail it to
the following address: Federal Trade Commission, Office of the
Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610, (Annex J),
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 J), Washington, DC
20024. If possible, submit your paper comment to the Commission by
courier or overnight service.
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 July 19, 2016.
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.
David C. Shonka,
Acting General Counsel.
[FR Doc. 2016-11952 Filed 5-19-16; 8:45 am]
BILLING CODE 6750-01-P