Contact Lens SNPRM - Supporting Statement - FINAL 2019

Contact Lens SNPRM - Supporting Statement - FINAL 2019.pdf

Contact Lens Rule

OMB: 3084-0127

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Supporting Statement
Proposed Amendments to the Contact Lens Rule
16 CFR § 315
(OMB Control # 3084-0127)
(1-2) Necessity for Collecting the Information/Use of the Information
The Federal Trade Commission promulgated the Contact Lens Rule (“Rule”) pursuant to
the Fairness to Contact Lens Consumers Act (“FCLCA”), Public Law 108-164 (December 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 contact lens prescribers to provide prescriptions to their patients upon the completion of
a contact lens fitting, and provide or verify such prescriptions to authorized third parties, such as
contact lens sellers. Sellers may provide contact lenses only in accordance with a valid
prescription that is presented directly to the seller or verified with the prescriber.
Section 315.3(a)(1) of the Rule requires a prescriber to provide a copy of the contact
lens prescription to the patient after completing a contact lens fitting, regardless of whether it was
requested by the patient. Section 315.3(a)(1) of the Rule tracks the language of the Act
verbatim.1 This provision, referred to as automatic prescription release, was intended to
empower consumers to comparison shop for contact lenses. Based on twelve years of experience
enforcing the Rule and careful consideration of public comments during the rule review,2 the
Commission determined that compliance with the law’s automatic prescription release provision
could be substantially improved.3 The Commission concluded that the potential benefits of
increasing the number of patients in possession of their prescriptions were substantial: increased
patient flexibility and choice in shopping for lenses; a reduced number of verification requests,
which many prescribers find burdensome; a reduced likelihood of errors associated with
incomplete or invalid prescriptions, which can jeopardize patient eye health; and a reduction in
the number and complications of failed attempts at verification. Increasing prescription-release
compliance also would likely spur competition and innovation among contact lens sellers and
manufacturers, and reduce attempts by sellers to verify incorrect, expired, and invalid
prescriptions, or to verify with the wrong prescriber. The Commission also determined that the
cumulative effect of increased automatic-release compliance would thus be lower costs and
improved convenience and flexibility for patients, sellers, and prescribers, as well as increased
1
15 U.S.C. 7601(a)(1).
2

Contact Lens Rule, Request for Comment, 80 Fed. Reg. 53,272 (September 3, 2015) (“Request for
Comment”).

In fact, the Commission has received evidence that a majority of consumers—between 56-65% —are not
receiving their contact lens prescriptions automatically as required by law, and millions of consumers are
not receiving them at all. Supplemental Notice of Proposed Rulemaking, 84 Fed. Reg. 24,664 (May 28,
2019) (“SNPRM”).

accuracy of prescriptions presented to sellers, thereby reducing potential consumer harm.
In 2016, the Commission proposed to amend the Rule to require that prescribers obtain a
signed acknowledgment after releasing a contact lens prescription and maintain each such
acknowledgment for a period of not less than three years.4 Requiring a signed acknowledgment
would increase the Commission’s ability to assess and verify compliance with the Rule.
After a subsequent review of additional public comments, workshop transcripts, and
various empirical surveys and analyses,5 the Commission is proposing to modify its prior
proposal for a signed acknowledgment requirement by instituting a more flexible Confirmation
of Prescription Release provision. The proposed modifications to the Rule would require that
prescribers either (1) obtain from patients, and maintain for a period of not less than three years,
a signed confirmation of prescription release on a separate stand-alone document; (2) obtain from
patients, and maintain for a period of not less than three years, a patient’s signature on a
confirmation of prescription release included on a copy of a patient’s prescription; (3) obtain
from patients, and maintain for a period of not less than three years, a patient’s signature on a
confirmation of prescription release included on a copy of a patient’s contact lens fitting sales
receipt; or (4) provide each patient with a copy of the prescription via online portal, electronic
mail, or text message, and for three years retain evidence that such was sent, received, or, if
provided via an online-patient portal, made accessible, downloadable, and printable by the
patient.
As discussed in the Supplemental Notice of Proposed Rulemaking (“SNPRM”), the
Commission believes that this modified proposal will achieve the goals of the original proposal
while imposing less of a burden on prescribers. Specifically, the modified proposal would
improve compliance with the congressionally-mandated automatic prescription release
requirement, and thereby benefit consumers and competition by ensuring that contact lens users
have the ability to comparison shop for lenses. Furthermore, the modified proposal will provide
much-needed improvements to the Commission’s ability to evaluate and enforce compliance
with this core provision of the Rule. Also, by allowing prescribers more options and flexibility,
the proposed modification will impose even less of an overall burden on prescribers than the
prior proposal, which the Commission had determined was relatively minimal.6
4
Notice of Proposed Rulemaking, 81 Fed. Reg. 88,526 (proposed Dec. 7, 2016) (“NPRM”).
5

Comments received in response to the NPRM are available at https://www.ftc.gov/policy/publiccomments/2016/10/initiative-677. Comments received in connection with the workshop are available at
https://www.ftc.gov/news-events/events-calendar/2018/03/contact-lens-rule-evolving-contact-lensmarketplace. See also Public Workshop Examining Contact Lens Marketplace and Analyzing Proposed
Changes to the Contact Lens Rule, 82 Fed. Reg. 57,889 (Dec. 8, 2017).
6

NPRM, 81 Fed. Reg. at 88,534, 88,557-58. The estimated Paperwork Reduction Act (“PRA”) burden
under the modified proposal is 597,917 hours for all prescribers and their staff, compared to 683,333 hours
for the signed acknowledgment proposal, a decrease of approximately 13 percent. The total cost estimate,

The proposed requirement to collect patient signatures and the associated recordkeeping
requirement would each constitute an information collection as defined by 5 CFR 1320.3(c).
Accordingly, the Commission is providing PRA burden estimates for them, as set forth below.
(3) Consideration of Using Improved Technology to Reduce Burden
The proposed amendments permit the covered firms to use paper or electronic format to
reduce the burden of information collection. Moreover, in its SNPRM, the Commission
specifically sought comments on ways to minimize the burden of the Rule’s collections of
information through the use of information technology.
Consistent with the Government Paperwork Reduction Elimination Act, Pub L. No. 105227, Title XVII, 112 Stat. 2681-749, nothing in the proposed amendments prescribes that the
disclosures be made, records be filed or kept, or signatures be executed, on paper or in any
particular format that would preclude the use of electronic methods to comply with the Rule’s
requirements.

(4) Efforts to Identify Duplication
The proposed recordkeeping requirements do not duplicate any other information
collection requirements imposed by the Commission. To the extent some state laws may already
require prescription release, and/or recordkeeping, similar to that required by the Act, prescribers
and sellers likely can comply with both requirements through a single release or record-keeping
system, thereby avoiding duplication.
(5) Efforts to Minimize Burden on Small Organizations
The proposed recordkeeping requirements are designed to impose the minimum burden on
all affected members of the industry, regardless of size. The Act itself does not allow the
Commission any latitude to treat small businesses differently, such as by exempting a particular
category of firm or setting forth a lesser standard of compliance for any category of firm.
While some contact lens prescribers subject to the Rule’s requirements are small
businesses, staff believes that everything consistent with the requirements of the Rule has been done
to minimize the compliance burden. Although the Act requires the Rule to apply to all covered
firms whether they are small entities or not, the Commission is seeking comment about minimizing
impact on small businesses.
however, is somewhat higher ($13,244,727 for the revised proposal compared to $10,475,495 for the prior
proposal) due to increases in labor costs since 2016, and the fact that the PRA estimate for the original
proposal did not include time required to obtain a patient’s signature, whereas the new proposal assigns that
time to prescribers (as opposed to office staff) and counts it as a PRA burden, in accordance with the
feedback of many NPRM commenters.

(6) Consequences of Conducting the Collection Less Frequently
The proposed recordkeeping requirement would require that sellers retain the required
records for a period of not less than three years. Staff believes that a record retention period
shorter than this would hamper the Commission’s ability to confirm contact lens prescribers’
compliance with the Rule, because the statute of limitations applicable to Commission rule
violations is three years.7

(7) Circumstances Requiring Collection Inconsistent With Guidelines
The proposed amendment’s information collection requirements are consistent with all
applicable guidelines contained in 5 C.F.R. § 1320.5(d)(2). Under the proposed rule amendments,
the Commission’s Rule would only require that covered entities maintain the form for three years.
Instances where records are required to be maintained longer than three years are mandated by
individual state laws.8
(8) Consultation Outside the Agency
On September 3, 2015, the Commission solicited comment on the Contact Lens Rule as
part of its periodic review of its rules and guides.9 As with other regulatory rule reviews, the
Commission sought comment on whether there is a continuing need for the Rule as currently
promulgated and about the Rule’s costs and benefits. The comment period closed on October 26,
2015. The Commission reviewed the 660 comments received in response to the initial request for
comments. Virtually all commenters agreed that there is a continuing need for the Rule and that it
benefits consumers and competition. The majority of commenters recommended some
modifications to the Rule in order to maximize the benefits to consumers and competition,
decrease the burden on businesses, protect consumers’ eye health, or improve overall compliance
with the Rule’s existing requirements. The Commission subsequently published an NPRM on
December 7, 2016. The sixty-day comment period closed on January 30, 2017. In its NPRM, the
Commission determined that the overall weight of the evidence demonstrated a need to improve
compliance with the Rule’s automatic prescription release requirement, as well as a need to create
a mechanism for monitoring and enforcing that requirement. Accordingly, the NPRM proposed to
7
See Section 19(d) of the FTC Act, 15 U.S.C. 57b(d).
8

See, e.g., 246 Mass. Code Regs. § 3.02 (requiring optometrists to maintain patient records for at least
seven years); Wash. Admin. Code § 246-851-290 (requiring optometrists to maintain records of eye exams
and prescriptions for at least five years); Iowa Admin. Code r. 645-182.2(2) (requiring optometrists to
maintain patient records for at least five years); Fla. Admin. Code r. 64B13-3.003(6) (requiring optometrists
to maintain patient records for at least five years).

2015 Request for Comment. Comments received in response to this request are available at
https://www.ftc.gov/policy/public-comments/2015/09/initiative-621.

amend the Rule to require that prescribers request that patients sign an acknowledgement form
upon receiving a copy of their contact lens prescription, and maintain each such acknowledgement
form for three years.10 In response to the NPRM, the Commission received over 4,000 additional
comments, many from prescribers concerned about the burden of the proposed signed
acknowledgment requirement.11
In light of the comments received on the NPRM, the Commission determined that it
would be beneficial to hold a public workshop on the Contact Lens Rule and the evolving contact
lens marketplace to explore issues raised throughout the comment process as well as topics related
to the evolution of the contact lens marketplace. On December 8, 2017, the Commission published
a Federal Register Notice announcing the March 7, 2018 workshop12 with a comment period
closing on April 6, 2018. The workshop included six panels, covering issues relating to the overall
contact lens marketplace, health and safety, competition, purchasing and verification, the proposed
signed acknowledgment and consumer choice, and the future of contact lens prescribing and
selling. In response to the Commission’s comment request and workshop, the Commission
received approximately 3,400 additional comments from a wide range of commenters, including
numerous consumers and prescribers, as well as industry associations, state attorneys general,
contact lens manufacturers, and retailers.13
After a thorough review of comments, workshop transcripts, and various empirical
surveys and analyses, the Commission is now issuing a Supplemental Notice of Proposed
Rulemaking, as opposed to implementing a Final Rule. Written comments must be received on or
before July 29, 2019.
(9) Payments and Gifts to Respondents
Not applicable.

10
The Commission also proposed a technical amendment, to remove the words “private label” from Section
315.5(e) to conform the language of the Rule to that of the FCLCA. In addition to seeking comment on
these proposals, the NPRM sought comment on the following issues: the provision of additional copies of
prescriptions, the amount of time for a prescriber to respond to such a request, the use of patient portals to
release prescriptions, and potential modifications to address concerns about automated telephone
verification calls.
11

Comments received in response to the NPRM are available at https://www.ftc.gov/policy/publiccomments/2016/10/initiative-677.
12

Public Workshop Examining Contact Lens Marketplace and Analyzing Proposed Changes to the Contact
Lens Rule, 82 Fed. Reg. 57,889 (Dec. 8, 2017).

Comments received in response to the workshop notice, as well as transcripts of, and materials from, the
workshop, are available at https://www.ftc.gov/news-events/events-calendar/2018/03/contact-lens-ruleevolving-contact-lens-marketplace.

(10-11) Assurances of Confidentiality/Matters of a Sensitive Nature
Not applicable. No assurance of confidentiality is necessary because although the
Contact Lens Rule requires regulated entities to disclose and/or maintain records, it does not
require the submission of any such records to the agency. Thus, to the extent, if any, that the
agency may require production of such records for law enforcement purposes in specific
proceedings, such production would not constitute an information collection activity within the
meaning of the PRA. In any event, in such proceedings, records would be protected by law from
mandatory public disclosure.14
(12) Estimated Annual Hours Burden and Associated Labor Cost
Estimated Additional Annual Hours Burden: 597,917 hours (85,417 hours regarding
signatures + 512,500 hours regarding their retention).
Commission staff estimates the PRA burden of the proposed modifications based on its
knowledge of the eye-care industry. The staff believes there will be an additional burden on
individual prescribers’ offices to generate and present to patients the confirmations of prescription
release, and to collect and maintain the confirmations of prescription release for a period of not less
than three years.
The number of contact lens wearers in the United States is currently estimated to be
approximately 41 million.15 Therefore, assuming an annual contact lens exam for each contact lens
wearer, approximately 41 million people would read and sign a confirmation of prescription
release every year.16
The Commission believes that generating and presenting the confirmation of prescription
release to patients will not require significant time. Creating the confirmation of prescription
release should be relatively straightforward for prescribers since the Commission’s proposal is
flexible in that it allows any one of several different modalities and delivery methods to satisfy the
requirement, including adding the confirmation to existing documents that prescribers routinely
provide (sales receipts) or are already required to provide (prescriptions) to patients. The
14
See, e.g., Section 21 of the FTC Act, 15 U.S.C. 57b-2; Exemption 6 of the Freedom of Information Act, 5
U.S.C. 552(b)(6).
15

Jennifer R. Cope et al., “Contact Lens Wearer Demographics and Risk Behaviors for Contact LensRelated Eye Infections—United States, 2014,” Morb. Mortal. Wkly. Rep. 64(32):865-70, 866 (Aug. 21,
2015).

In the past, some commenters have suggested that typical contact lens wearers obtain annual exams every
18 months or so, rather than one every year. Because most prescriptions are valid for a minimum of one
year under the Rule, Commission staff will continue to assume conservatively for purposes of PRA burden
estimation that patients seek exams every 12 months. However, as discussed infra, note 21 and
accompanying text, prescription-confirmation releases would not be required under option §

315.5(c)(1)(iv).

Commission’s proposal is also flexible in that it does not prescribe other details such as the precise
content or language of the patient confirmation, but merely requires that, if provided to the patient
in-person, the confirmation from the consumer must be in writing. At the same time, the
Commission’s proposal does not require that prescribers spend time generating their own content
for the confirmation, since the Commission has provided draft language that prescribers are free to
use to satisfy the requirement, if they so desire. Furthermore, the confirmation proposal is flexible
enough to cover situations where a contact lens fitting is completed remotely, since a prescriber
can readily satisfy the requirement by various methods, including email, text, or uploading the
prescription to a patient portal.
The four proposed options for a prescriber to confirm a prescription release to a patient are
set out in § 315.3(c). The first three options (§ 315.3(c)(1)(i), (ii), and (iii)), which direct a
prescriber to provide information to a patient in the form of a confirmation of prescription release,
are not disclosures constituting an information collection under the PRA because the FTC has
supplied the prescriber with draft language the prescriber can use to satisfy this requirement.17
However, as noted above, the collection of a patient’s signature and the associated recordkeeping
required constitutes an information collection as defined by OMB regulations that implement the
PRA. Nonetheless, the Commission believes it will require minimal time for a patient to read the
confirmation of prescription release and provide a signature. Based on a survey submitted in
response to the NPRM, it would take consumers, on average, twelve seconds to read the twosentence acknowledgment proposed by the Commission at the NPRM stage.18 Since the new
proposed confirmation of prescription release would be significantly shorter than the prior
proposed acknowledgment, Commission staff expects that the time required to read and sign such
confirmation would be less, perhaps half (six seconds). As noted above, a somewhat similar
written acknowledgment requirement under HIPAA was estimated to require ten seconds for the
consumer to complete.19 Based on the consumer survey and prior estimate, the Commission allots
ten seconds for the consumer to read and provide a signature.
The fourth option, § 315.3(c)(1)(iv), does not constitute an information collection under
the PRA, since no new information is provided or requested of the patient. Excluding that from
consideration and assuming the remaining three options are exercised with equal frequency, threefourths or 75% of approximately 41 million annual prescription releases otherwise entail reading

17
“The public disclosure of information originally supplied by the Federal government to the recipient for
the purpose of disclosure to the public is not included within” the definition of “collection of information.”
5 CFR 1320.3(c)(2).
18

Laurence C. Baker, “Analysis of Costs and Benefits of the FTC Proposed Patient Acknowledgment and
Recordkeeping Amendment to the Contact Lens Rule,” 11 (2017),
https://www.ftc.gov/system/files/summaries/initiatives/677/meeting_summary_for_the_contact_lens_rulem
aking_proceeding.pdf. The median was ten seconds.
19

67 FR at 53261.

and signing a confirmation statement. Thus, 85,417 hours, cumulatively (75% x 41 million
prescriptions yearly x ten seconds each) would be devoted to those tasks.20
Maintaining those signed confirmations for a period of not less than three years should not
impose substantial new burden on individual prescribers and their office staff. The majority of
states already require that optometrists keep records of eye examinations for at least three years,21
and thus many prescribers who opt to include the confirmation of prescription release on the
prescription itself would be preserving that document, regardless. Similarly, most prescribers
already retain customer sales receipts for financial recordkeeping purposes, and thus prescribers
who opt to include the confirmation of prescription release on the sales receipt also could be
retaining that document, regardless. Moreover, storing a one-page document per patient per year
should not require more than a few seconds, and an inconsequential, or de minimis, amount of
record space. As noted above, some prescribers might present the confirmation of prescription
release electronically, and such format would allow the confirmation to be preserved without any
additional burden. For other prescribers, the new recordkeeping requirement would likely require
that office staff either preserve the confirmation in paper format or electronically scan the signed
confirmation and save it as an electronic document. For prescribers who preserve the confirmation
electronically, Commission staff estimates that scanning and saving the document would consume
approximately one minute. Commission staff do not possess detailed information on the
percentage of prescribers’ offices that use paper forms, electronic forms, or that scan paper files
and maintain them electronically. Thus, for purposes of this PRA analysis, Commission staff will
conservatively assume that all prescriber offices require a full minute per confirmation for
recordkeeping arising from the proposed modifications.
Excluding from PRA consideration the fourth option, §315.3(c)(1)(iv), as there is no
signature to obtain or retain, and assuming that prescribers elect the remaining options threefourths or 75% of the time, the recordkeeping burden for all prescribers to scan and save such
confirmations would amount to 512,500 hours (75% x 41 million prescriptions yearly x one
minute) per year. Thus, estimated incremental PRA recordkeeping burden for prescribers resulting
from the proposed Rule modifications is 597,917 hours (85,417 hours regarding signatures +
512,500 hours regarding their retention).

20
The FTC has previously accounted for and retains active OMB clearance regarding its separate PRA
burden estimates for prescriber release of prescriptions to patients (as opposed to the instant burden estimate
for the time to read and sign a confirmation statement). Those previous estimates were one minute per
prescriber and 683,333 hours, cumulative of the estimated 41 million prescriptions released annually. See
81 FR 31398, at 31939 (May 20, 2016); 81 FR 62501, at 62501 (Sept. 9, 2016).
21

Arguably, the overall burden of the Rule—including verification costs previously
approved by the Office of Management and Budget22—could lessen (or not increase by as much as
the incremental burden from the proposed Rule modifications), given potentially offsetting effects
presented by the proposed modifications. As noted above, some commenters suggested that the
increased burden from the proposed signed-acknowledgment requirement would be lessened or
even outweighed by a reduced verification burden, because with more patients in possession of
their prescriptions and able to present them to third-party sellers, fewer time-consuming
verifications would be necessary.23 Based on some commenter and Commission projections, a
decrease of between 9%-23% in verifications could be sufficient to offset the entire cost of the
signed-acknowledgment proposal.24 Since the estimated burden for the confirmation of
prescription release proposal is similar to that of the signed acknowledgment,25 and would be
expected to have the same offsetting effects, it is possible that the burden of the proposed
modification would be offset to a great extent by a reduction in verifications. In the SNPRM, the
Commission requests additional comment on whether and by how much a reduction in
verifications would result from the confirmation of prescription proposal.
Since the Confirmation of Prescription Release proposal—in contrast to the SignedAcknowledgment proposal—exempts prescribers who do not have a direct or indirect financial
interest in the sale of contact lenses, this will also reduce the burden created by the new
requirement. The Commission, however, does not currently possess information as to how many
prescribers would qualify for the exemption due to a lack of financial interest in the sale of lenses.
The Commission therefore has not reduced its PRA burden estimate accordingly. Instead, the
22
The Commission has estimated that prescribers’ offices spend five minutes per verification request, based
on information provided by the American Optometric Association. Agency Information Collection
Activities; Submission for OMB Review, 81 FR 62501 (Sept. 9, 2016). The Commission has also estimated
that sellers spend five minutes per verification request, and one minute on recordkeeping in non-verification
circumstances (to preserve the prescription when presented by a patient); OMB Control No. 3084-0127.
23

SNPRM at 24,678 [notes 183-190 and accompanying text].

Based on the estimated burden for the Commission’s prior signed-acknowledgment requirement proposal.
SNPRM at 24,678 [note 186 and accompanying text].

The estimated burden of the proposed confirmation requirement is lower than the signed-acknowledgment
burden in terms of time required (597,917 hours for all prescribers and their staff compared to 683,333
hours for the signed-acknowledgment proposal, a decrease of approximately 13 percent). However, the
estimated total financial burden is somewhat higher due to increases in average hourly wages for prescribers
and staff since 2016, and due to the addition of time—now assigned to prescribers—to obtain a signature, in
response to comments and information received subsequent to publication of the NPRM. Because of the
higher overall cost, it might require a greater respective decrease in verifications to offset the financial
burden. As noted, however, in the SNPRM at 24, 693 [note 352 and accompanying text], none of the
monetary burden-offset calculations takes into account the expected benefit to consumers of having their
prescriptions and being able to choose from among competing providers; the savings consumers might
achieve by purchasing lower-priced lenses; the improvements to health and safety due to a reduction in
errors associated with invalid prescriptions currently verified through passive verification; and the
Commission’s improved ability to assess and verify compliance with the Rule.

SNPRM requests comment on the percentage of prescribers who would qualify for the proposed §
315.3(c)(3) exemption.
This PRA analysis also does not attempt to assess and estimate hours or cost burden for
sellers regarding the proposed Rule modifications that would require those who use automated
telephone messages, wholly or in part, to verify a prescription, to record the full call, among other
steps associated with that proposed modification. As noted in the SNPRM’s Section VIII.E.
(Request for Comments/Automated Telephone Verification Messages), the Commission seeks
comments to help inform such estimated burden, to the extent applicable.
Estimated Total Annual Labor Cost Burden: $13,244,727.
Commission staff derives labor costs by applying appropriate hourly cost figures to the
burden hours described above. The prescriber task to obtain patient signed acknowledgments
theoretically could be performed by medical professionals (e.g., optometrists, ophthalmologists) or
support staff (e.g., dispensing opticians, ophthalmic medical technicians). To estimate associated
labor costs, staff will conservatively assume that optometrists would perform the task.26 Applying
a mean hourly wage of $57.2627 for optometrists to the above-noted estimate of 85,417 hours,
resultant aggregate labor costs to obtain patient signatures would be $4,890,977.
Commission staff assumes that office clerks will typically perform the labor pertaining to
the printing, scanning and storing of prescription release confirmations. Applying a mean hourly
wage for office clerks of $16.30 per hour,28 to the above-noted estimate of 512,500 hours,
cumulative labor costs for those tasks would total $8,353,750.
Therefore, combining the aggregate labor costs for both prescribers and office staff to
obtain patient signed acknowledgments and preserve the associated records, the Commission
estimates the total labor burden of the confirmation of prescription release proposal to be
$13,244,727.

26
It is not certain that this assumption is well-founded. See CLR Panel IV Tr., SNPRM at 24,674 [note 126,
at 8] (statements of David Cockrell that, in his office, the staff handle all the verification calls). Many
prescribers may use office staff to handle verification calls, which would result in a significantly lower
burden calculation for prescribers’ offices than what the Commission previously calculated. Without more
empirical data as to who handles most verification requests, however, the Commission will continue to use
the estimate for prescribers, even if it might overstate the actual burden.
27

Economic News Release, U.S. Dep’t of Labor, Bureau of Labor Statistics, Table 1. National employment
and wage data from the Occupational Employment Statistics survey by occupation, May 2017:
https://www.bls.gov/news.release/ocwage.t01.htm (“BLS Table 1”).
28

BLS Table 1.

(13) Estimated Annual Capital or Other Non-Labor Costs
The proposed recordkeeping requirements detailed above regarding prescribers impose
negligible capital or other non-labor costs, as prescribers likely have already the necessary
equipment and supplies (e.g., prescription pads, patients’ medical charts, scanning devices,
recordkeeping storage) to act upon those requirements.
(14) Estimated Cost to Federal Government
Staff believes that the cost to the FTC for administering the proposed Rule changes will
be de minimis. Accordingly, Commission staff retains the previous estimate of $52,000 per year
as the cost to the Government for implementing the Rule. This estimate is based on the
assumption that 15-20% of one Attorney work year, 2.5% of one Economist work year, 15% of
one Investigator work year, and 15% of one Paralegal work year will be expended to enforce the
Rule’s requirements.
(15) Program Changes/Adjustments
The proposed amendments will result in an estimated additional 597,917 burden
hours, annualized, and cumulative of all affected manufacturers, $13,244,727 in associated
labor costs, and negligible capital/non-labor costs.
(16) Plans for Tabulation and Publication
Not applicable. There are no plans to publish for statistical use any information required
by the Rule.
(17) Requested Permission Not to Display the Expiration Date for OMB Approval
This is not applicable, since the Commission will display the expiration date of the
clearance.
(18) Exceptions to the “Certification for Paperwork Reduction Act Submissions”
Not applicable.

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