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Federal Register / Vol. 75, No. 72 / Thursday, April 15, 2010 / Notices
United States is estimated to be
approximately 34 million.1 Therefore,
assuming an annual contact lens exam
for each contact lens wearer, 34 million
people would receive a copy of their
prescription each year under the Rule.
At an estimated one minute per
prescription, the annual time spent by
prescribers complying with the
disclosure requirement would be a
maximum of 567,000 hours. [(34 million
× 1 minute)/60 minutes = 566,667
hours]
As required by the FCLCA, the Rule
also imposes two recordkeeping
requirements. First, prescribers 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. The
OMB regulation that implements the
PRA defines ‘‘burden’’ to exclude any
effort that would be expended
regardless of a regulatory requirement. 5
CFR 1320.3(B)(3)(2).
Second, the Rule requires contact lens
sellers to maintain certain documents
relating to contact lens sales. As noted
above, a 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 FCLCA 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 this requirement is low.
Sellers who seek verification of contact
lens prescriptions must retain one or
two records for each contact lens sale:
Either the relevant prescription itself, or
the verification request and any
response from the prescriber. Staff
estimates that such recordkeeping will
entail a maximum of five minutes per
sale, including time spent preparing a
file and actually filing the record(s).
Staff also believes that, based on its
knowledge of the industry, this burden
will fall primarily on mail order and
Internet-based sellers of contact lenses,
1 See Contact Lenses, Frequently Asked
Questions, Nov. 2009, available at (http://
www.allaboutvision.com/faq/contactlens.htm.) See
also Nichols, J. ‘‘Annual Report: Contact Lenses
2008,’’ Contact Lens Spectrum, Jan. 2009, available
at (http://www.clspectrum.com/
article.aspx?article=102473).
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as they are the entities in the industry
most reliant on obtaining or verifying
contact lens prescriptions. Based on
conversations with the industry, staff
estimates that these entities currently
account for approximately 10% of sales
in the contact lens market2 and, by
extension, that approximately 3.4
million consumers—10% of the 34
million contact lens wearers in the
United States—purchase their lenses
from them.
At an estimated five minutes per sale
to each of 3.4 million consumers,
contact lens sellers will spend a total of
283,300 burden hours complying with
the recordkeeping requirement. [(3.4
million × 5 minutes)/60 minutes =
283,333.3 hours] This estimate likely
overstates the actual burden, however,
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 larger online sellers.
Estimated labor costs: $32,317,000
(rounded to the nearest thousand).
Commission staff derived labor costs
by applying appropriate hourly cost
figures to the burden hours described
above. Staff estimates, based on its
knowledge of the industry, that
optometrists account for approximately
75% 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 from May 2008, salaried
optometrists earn an average wage of
$50.58 per hour and general office
clerical personnel earn an average of
$12.90 per hour.3
With these categories of personnel,
respectively, likely to perform the brunt
of the disclosure (for optometrists) and
recordkeeping (for office clerks) aspects
of the Rule, estimated total labor cost
attributable to the Rule would be
approximately $32.8 million. [($50.58 ×
2 The FTC’s February 2005 study, ‘‘The Strength
of Competition in the Rx Sale of Contact Lenses: An
FTC Study,’’ cites various data that, averaged
together, suggests that approximately 10% of
contact lens sales are by online and mail-order
sellers. The report is available online at (http://
www.ftc.gov/reports/contactlens/
050214contactlensrpt.pdf).
3 Mean and median worker hourly wages for
optometrists and general office clerks are drawn
from the Bureau of Labor Statistics (BLS)
Occupational Employment and Statistics Survey,
May 2008, based on BLS-sampled data it collected
over a 3-year period. See (http://www.bls.gov/
news.release/pdf/ocwage.pdf) (Table 1).
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19649
566,666.7 hours) + ($12.90 × 283,333.3
hours) = $32,317,000]
The contact lens market is a
multibillion dollar market; one recent
survey estimates that contact lens sales
totaled $2.37 billion from Jan 1, 2006 to
Dec 31, 2006.4 Thus, the total labor cost
burden estimate of $32.3 million
represents approximately 1.5% of the
overall market.
Estimated annual non-labor cost
burden: $0 or minimal.
Staff believes that the Rule’s
disclosure and recordkeeping
requirements impose negligible capital
or other non-labor costs, as the affected
entities are likely to have the necessary
supplies and/or equipment already (e.g.,
prescription pads, patients’ medical
charts, facsimile machines and paper,
telephones, and recordkeeping facilities
such as filing cabinets or other storage).
Willard Tom,
General Counsel.
[FR Doc. 2010–8647 Filed 4–14–10: 8:45 am]
BILLING CODE: 6750–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–0371.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: HRSA AIDS
Education and Training Centers
Evaluation Activities (OMB No. 0915–
0281)—Revision
The AIDS Education and Training
Centers (AETC) Program, under the Title
XXVI of the Public Health Service Act,
as amended, Ryan White HIV/AIDS
Program legislation, supports a network
4 The Vision Council of America and Jobson
Optical Research have conducted large scale
continuous consumer research under the name
VisionWatch, which reports on the vision care
industry. The basis for this statistic is on file with
the Federal Trade Commission.
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Federal Register / Vol. 75, No. 72 / Thursday, April 15, 2010 / Notices
of regional and cross-cutting national
centers that conduct targeted, multidisciplinary education and training
programs for health care providers
treating persons with HIV/AIDS. The
AETCs’ purpose is to increase the
number of health care providers who are
effectively educated and motivated to
counsel, diagnose, treat, and medically
manage individuals with HIV infection,
and to help prevent high risk behaviors
that lead to HIV transmission.
As part of an ongoing effort to
evaluate AETC activities, information is
needed on AETC training sessions,
consultations, and technical assistance
activities. Each regional center collects
achieved through training events.
Collection of this information allows
HRSA and HAB to provide information
on training activities and types of
education and training provided to Ryan
White HIV/AIDS Program Grantees,
resource allocation, and capacity
expansion.
Trainees are asked to complete the
Participant Information Form (PIF) for
each activity they complete, and
trainers, are asked to complete the Event
Record (ER). The estimated annual
response burden to trainers as well as
attendees of training programs is as
follows:
forms on AETC training events, and the
centers are required to report aggregate
data on their activities to HRSA and the
HIV/AIDS Bureau (HAB). This data
collection provides information on the
number of training events, including
clinical trainings and consultations, as
well as technical assistance activities
conducted by each regional center, the
number of health care providers
receiving professional training or
consultation, and the time and effort
expended on different levels of training
and consultation activities. In addition,
information is obtained on the
populations served by the AETC
trainees, and the increase in capacity
Responses
per
respondent
Number of
respondents
Form
Total
responses
Hours per
response
Total burden
hours
PIF ....................................................................................
ER ....................................................................................
116,624
18,070
1
1
116,624
18,070
0.167
0.2
19,476.2
3,614
Total ..........................................................................
134,694
........................
134,694
..........................
23,090.2
Number of
respondents
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
12
2
24
32
768
The estimated annual burden to
AETCs is as follows:
Aggregate data set ..............................................................
The total burden hours are 23,858.2.
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to [email protected]
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
Dated: April 7, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–8622 Filed 4–14–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSKH9S0YB1PROD with NOTICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 350(c)(2)(A) of Title 44, United
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States Code, as amended by the
Paperwork Reduction Act of 1995
Public Law 104–13, the Health
Resources and Services Administration
(HRSA) will publish periodic
summaries of proposed projects being
developed for submission to the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
1995. To request more information on
the proposed project or to obtain a copy
of the data collection plans, call HRSA
Reports Clearance Officer at 301–443–
1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be collected
and; (d) ways to minimize the burden of
the collection of information on
respondents, including through the use
of automated collection techniques of
other forms of information technology.
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Proposed Project: Scholarships for
Disadvantaged Students Program (OMB
No. 0915–0149) Extension
The Scholarships for Disadvantaged
Students (SDS) Program has as its
purpose the provision of funds to
eligible schools to provide scholarships
to full-time students with financial need
from disadvantaged backgrounds
enrolled in health professions and
nursing programs.
To qualify for participation in the SDS
program, a school must be carrying out
a program for recruiting and retaining
students from disadvantaged
backgrounds, including students who
are members of racial and ethnic
minority groups (section 737(d)(1)(B) of
the Public Health Service (PHS) Act). A
school must meet the eligibility criteria
to demonstrate that the program has
achieved success based on the number
and/or percentage of disadvantaged
students who graduate from the school.
In awarding SDS funds to eligible
schools, funding priorities must be
given to schools based on the proportion
of graduating students going into
primary care, the proportion of
underrepresented minority students,
and the proportion of graduates working
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File Type | application/pdf |
File Title | Document |
Subject | Extracted Pages |
Author | U.S. Government Printing Office |
File Modified | 2010-04-15 |
File Created | 2010-04-15 |