Proposed Rule2023-01804
Controlled Substances Ordering System (CSOS) Modernization
Primary source
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Published
February 2, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
This rule proposes to amend the Drug Enforcement Administration's (DEA) regulations to conform to the Controlled Substances Ordering System (CSOS) modernization effort by requiring all CSOS enrollment applications and supporting materials to be submitted through the Diversion Control Division secure online portal. These amendments would improve the enrollment process by aligning it with DEA's current requirements for other online form submissions. The online submission of enrollment applications and supporting material through the secure network application portal would increase the efficiency of the enrollment, modification, and revocation processes, and ensure DEA's receipt of accurate documentation in a more timely and organized manner.
Full Text
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<title>Federal Register, Volume 88 Issue 22 (Thursday, February 2, 2023)</title>
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[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Proposed Rules]
[Pages 7033-7044]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-01804]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1311
[Docket No. DEA-732]
RIN 1117-AB79
Controlled Substances Ordering System (CSOS) Modernization
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: This rule proposes to amend the Drug Enforcement
Administration's (DEA) regulations to conform to the Controlled
Substances Ordering System (CSOS) modernization effort by requiring all
CSOS enrollment applications and supporting materials to be submitted
through the Diversion Control Division secure online portal. These
amendments would improve the enrollment process by aligning it with
DEA's current requirements for other online form submissions. The
online submission of enrollment applications and supporting material
through the secure network application portal would increase the
efficiency of the enrollment, modification, and revocation processes,
and ensure DEA's receipt of accurate documentation in a more timely and
organized manner.
DATES: Electronic comments must be submitted, and written comments must
be postmarked, on or before April 3, 2023. Commenters should be aware
that the electronic Federal Docket Management System will not accept
any comments after 11:59 p.m. Eastern Time on the last day of the
comment period.
All comments concerning collections of information under the
Paperwork Reduction Act must be submitted to the Office of Management
and Budget on or before April 3, 2023.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-732'' on all correspondence, including any
attachments.
<bullet> Electronic comments: The Drug Enforcement Administration
(DEA) encourages that all comments be submitted electronically through
the Federal eRulemaking Portal which provides the ability to type short
comments directly into the comment field on the web page or attach a
file for lengthier comments. Please go to <a href="http://www.regulations.gov">http://www.regulations.gov</a>
and follow the online instructions at that site for submitting
comments. Upon completion of your submission, you will receive a
Comment Tracking Number for your comment. Please be aware that
submitted comments are not instantaneously available for public view on
<a href="http://Regulations.gov">Regulations.gov</a>. If you have received a Comment Tracking Number, your
comment has been successfully submitted and there is no need to
resubmit the same comment.
<bullet> Paper comments: Paper comments that duplicate electronic
submissions are not necessary. Should you wish to mail a paper comment,
in lieu of an electronic comment, it should be sent via regular or
express mail to: Drug Enforcement Administration, Attn: DEA Federal
Register Representative/DPW, 8701 Morrissette Drive, Springfield,
Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 776-2265.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received are considered part of the
public record. They will, unless reasonable cause is given, be made
available by the Drug Enforcement Administration (DEA) for public
inspection online at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Such information
includes personal identifying information (such as your name, address,
etc.) voluntarily submitted by the commenter. The Freedom of
Information Act applies to all comments received. If you want to submit
personal identifying information (such as your name, address, etc.) as
part of your comment, but do not want it to be made publicly available,
you must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the
first paragraph of your comment. You must also place all of the
personal identifying information you do not want made publicly
available in the first paragraph of your comment and identify what
information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify the
confidential business information to be redacted within the comment.
Comments containing personal identifying information or
confidential business information identified as directed above will be
made publicly available in redacted form. If a comment has so much
confidential business information that it cannot be effectively
redacted, all or part of that comment may not be made publicly
available. Comments posted to <a href="http://www.regulations.gov">http://www.regulations.gov</a> may include
any personal identifying information (such as name, address, and phone
number) included in the text of your electronic submission that is not
identified as confidential as directed above.
An electronic copy of this proposed rule is available at <a href="http://www.regulations.gov">http://www.regulations.gov</a> for easy reference.
Legal Authority
The Controlled Substances Act (CSA) grants the Attorney General
authority to promulgate rules and regulations relating to: the
registration and control of the manufacture, distribution, and
dispensing of controlled substances and listed chemicals; reporting
changes to professional or business addresses; and the efficient
execution of his statutory functions. 21 U.S.C. 821, 822(a), 827(h),
871(b), 957(a). The Attorney General is further authorized by the CSA
to promulgate rules and regulations relating to the registration and
control of importers and exporters of controlled substances and listed
chemicals.\1\ The Attorney General has delegated this authority to the
Administrator of DEA.\2\
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\1\ 21 U.S.C. 958(f).
\2\ 28 CFR 0.100(b).
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The CSA defines ``distribute'' as ``to deliver (other than by
administering or dispensing) a controlled substance or a listed
chemical'' and ``distributor'' as ``a person who so delivers a
controlled substance or a listed chemical.'' \3\ The CSA further
provides that it ``shall be unlawful for any person to distribute a
controlled substance in schedule I or II to another except in pursuance
of a written order of the person to whom such substance is distributed,
made on a form to be issued by the Attorney General in blank in
accordance with subsection (d) of this section and regulations
prescribed by him pursuant
[[Page 7034]]
to this section.'' \4\ ``Every person who gives an order required under
subsection (a) of this section shall, at or before the time of giving
such order, make or cause to be made a duplicate thereof on a form to
be issued by the Attorney General in blank in accordance with
subsection (d) of this section and regulations prescribed by him
pursuant to this section, and shall, if such order is accepted,
preserve such duplicate for a period of two years and make it available
for inspection and copying . . . . '' \5\ ``The Attorney General shall
issue forms . . . only to persons validly registered under section 823
of this title (or exempted from registration under section 822(d) of
this title). Whenever any such form is issued to a person, the Attorney
General shall, before delivery thereof, insert therein the name of such
person, and it shall be unlawful for any other person (A) to use such
form for the purpose of obtaining controlled substances or (B) to
furnish such form to any person with intent thereby to procure the
distribution of such substances.'' \6\
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\3\ 21 U.S.C. 802(11).
\4\ 21 U.S.C. 828(a).
\5\ 21 U.S.C. 828(c)(2).
\6\ 21 U.S.C. 828(d)(1).
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Implementation of the CSA Written Order Form Requirement
Paper DEA Form 222
In 1971 DEA implemented the CSA's written order form requirement by
publishing a final rule requiring triplicate paper DEA Form 222s.\7\ In
2019, DEA amended its regulations to create a new single-sheet format
for the paper DEA Form 222s.\8\ The rule contained transition
provisions allowing registrants to continue to use their existing
stocks of the triplicate paper DEA Form 222s until their supply was
exhausted, or until October 30, 2021, whichever came sooner.\9\
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\7\ 36 FR 7776, April 24, 1971.
\8\ DEA Notice of Proposed Rulemaking titled ``New Single-Sheet
Format for U.S. Official Order form for Schedule I and II Controlled
Substances (DEA Form 222),'' published in the Federal Register on
February 21, 2019, and DEA Final Rule titled ``New Single-Sheet
Format for U.S. Official Order Form for schedule I and II Controlled
Substances (DEA Form 222),'' published in the Federal Register on
September 30, 2019, at 84 FR 51368.
\9\ 21 CFR 1305.20.
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Electronic DEA Form 222
In 2005, DEA published a final rule amending its regulations to
provide an electronic equivalent to the DEA Form 222 (also known as
CSOS).\10\ The amendments allowed registrants to order schedule I and
II controlled substances electronically and maintain records of these
orders electronically. The intent of these amendments was to reduce
paperwork and transaction times for DEA registrants who sell or buy
controlled substances.
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\10\ DEA Notice of Proposed Rulemaking titled ``Electronic
Orders for Controlled Substances,'' published in the Federal
Register on June 27, 2003, at 68 FR 38557 and DEA Final Rule titled
``Electronic Orders for Controlled Substances,'' published in the
Federal Register on April 1, 2005, at 70 FR 16901.
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Summary of Current CSOS Regulations
The current CSOS regulations are found in 21 CFR parts 1305 and
1311. DEA Registrants use CSOS as a secure system to track schedule I
and II controlled substance orders. The system allows for secure
electronic controlled substances orders without the need for a paper
order form (DEA Form 222). Using Public Key Infrastructure (PKI), CSOS
requires that each individual supplier and purchaser enroll with DEA to
acquire a CSOS digital certificate. System enhancements will allow
electronic documentation submission, self-service support options, and
electronic processing of single and bulk applications, renewals, and
revocations. Users will be able to electronically search for, revoke,
report, retrieve, and renew secure digital certificates.
Purpose of Rule
Current regulations require registrants who wish to participate in
the CSOS system to enroll using a labor intensive manual process which
relies on paper applications. The paper application must be notarized
and the package mailed to DEA, creating delays in the enrollment
process and putting applications at risk of being lost.\11\ The purpose
of this rule is to simplify the application process by requiring all
CSOS enrollment applications to be submitted online. All applicants for
enrollment will follow the CSOS link on the <a href="http://deadiversion.gov">deadiversion.gov</a> website to
the CSOS log-in page. From the CSOS log-in page the applicant will be
redirected to <a href="http://Login.gov">Login.gov</a> for Identification Verification. Upon arrival
at the site, the applicant will be asked to create a <a href="http://Login.gov">Login.gov</a> account
by entering a valid email address, selecting a default language, and
agreeing to <a href="http://Login.gov">Login.gov</a>'s Rules of Behavior. A confirmation email will
then be sent to the applicant's selected email. Once the email has been
confirmed, the applicant must create a <a href="http://Login.gov">Login.gov</a> password by providing
a telephone number to which a verification code can be sent. Once the
code is sent and the applicant enters the given code on the <a href="http://Login.gov">Login.gov</a>
website, the applicant must agree to the site's security statement.
<a href="http://Login.gov">Login.gov</a> next requires applicants to upload photographs of one or more
forms of identification as specified by <a href="http://Login.gov">Login.gov</a> and to enter a Social
Security Number, after which the applicant is asked to verify the given
information. The applicant is next asked to re-enter their <a href="http://Login.gov">Login.gov</a>
password to receive a Personal Key by separate message. The applicant
is then asked to enter that Personal Key and review their information.
Upon review of the information, the applicant is then directed back to
the CSOS website for further processing. Upon return to the CSOS
website, the applicant is asked to agree to the CSOS User Agreement and
can apply for one of three system user roles (Registrant, Coordinator,
or Power of Attorney in order of superiority) with enrollment requests
approved or rejected by the superior role. After the Registrant role is
established, all subordinate applications for enrollment for the
Coordinator role must be approved by the Registrant. Upon establishment
of a Coordinator, all subordinate applications for enrollment for the
Power of Attorney role must be approved in the system by the
responsible Coordinator. This proposed rule would amend DEA regulations
to require electronic enrollment through a secure web-based system.
Submission through the secure online system will be a streamlined
process which will benefit both DEA and CSOS participants.
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\11\ 21 CFR part 1311 et seq.
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Discussion of Regulatory Changes
Need for Regulatory Changes
Regulatory changes are needed to conform existing DEA regulations
regarding the submission of the paper CSOS system enrollment forms to
DEA's current requirements that other DEA forms be submitted
online.\12\ The paper enrollment process is prone to errors, creates
wasteful and unnecessary paper records, requires manual processing,
[[Page 7035]]
and is expensive to process and store. This rule proposes to amend
existing DEA regulations in one part--Title 21 Chapter II Part 1311.
DEA is proposing to amend 21 CFR 1311 to require all CSOS enrollment
applications and supporting materials to be submitted to DEA through
the CSOS secure network portal. This amendment would improve the
submission process by aligning it with DEA's current policy of reducing
and/or eliminating the reliance on wasteful paper applications and
expediting enrollment by utilizing modern technology. The online
submission of applications and supporting materials through the secure
database will ensure DEA's receipt of documentation in a more timely
and organized manner.
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\12\ See Reporting of Theft or Significant Loss of Controlled
Substances, 85 FR 146 (July 29, 2020) (published NPRM proposing to
require all DEA Form 106's to be submitted electronically);
Suspicious Orders of Controlled Substances, 85 FR 212 (Nov. 02,
2020) (published NPRM proposing centralized electronic reporting for
SORS based on Congressional mandate); Agency Rule List--Spring 2021
(2021), <a href="https://www.reginfo.gov/public/do/eAgendaMain?operation=OPERATION_GET_AGENCY_RULE_LIST¤tPub=true&agencyCode=&showStage=active&agencyCd=1100&csrf_token=F19C7C599C70B80C228EC16B60AEB150F6339AF3C80E56FE003EEB7D3A758895BC8E16A215E8A0466326EBFBA8639F799E09">https://www.reginfo.gov/public/do/eAgendaMain?operation=OPERATION_GET_AGENCY_RULE_LIST¤tPub=true&agencyCode=&showStage=active&agencyCd=1100&csrf_token=F19C7C599C70B80C228EC16B60AEB150F6339AF3C80E56FE003EEB7D3A758895BC8E16A215E8A0466326EBFBA8639F799E09</a> (Spring 2021 Unified Agenda of Regulatory and
Deregulatory Actions, Active Regulatory Actions Listed By Agency,
Agency Rule list noting proposed rule stage for Electronic
Submission of DEA Form 41 (Registrant Record of Controlled
Substances Destroyed) -1117-AB59).
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Section by Section Analysis
DEA is proposing to amend 21 CFR 1311.20, 1311.25, 1311.40, and
1311.60 by eliminating the ability of registrants to submit paper CSOS
enrollment application forms. Registrants would thus be required to
submit all their application materials through the secure online
portal. Moreover, DEA is proposing to amend these regulations by
eliminating certain recordkeeping requirements, as those records would
now be accessible as a digital version in the system. DEA believes
these amendments would expedite the enrollment process for registrants
and facilitate the Agency-wide goal of reducing DEA's reliance on paper
forms.
DEA is proposing to amend Sec. 1311.20, which describes the role
and responsibilities of the CSOS Coordinator. Current regulations
require the CSOS Coordinator to complete the paper application process
by submitting the notarized enrollment package to DEA Certification
Authority for processing. This proposed amendment would streamline the
process by eliminating the paper process and requiring Coordinator
applicants to enroll using the secure online portal.
Additionally, DEA is proposing to amend Sec. 1311.25, which
establishes the requirements for a registrant, or authorized
representative with a Power of Attorney, to complete the manual
application process by submitting the notarized enrollment package to
the DEA Certification Authority for processing. This proposed amendment
would streamline the process by eliminating the manual paper process
and require all Registrants, or authorized representative with a Power
of Attorney to enroll using the secure online portal.
DEA is also proposing to amend Sec. 1311.40, which establishes the
criteria for renewal of a CSOS digital certificate by the manual paper
process. This proposed amendment would streamline the renewal process
by eliminating the manual paper process and require that all renewal
applications be submitted using the secure online portal.
Last, DEA is proposing to amend Sec. 1311.60, which establishes
recordkeeping requirements on the part of the CSOS Certificate holder
by requiring that a copy of the subscriber agreement be maintained for
the life of the certificate. This proposed amendment would remove the
requirement of the CSOS Certificate holder to maintain a copy of the
subscriber agreement by enabling registrants to sign and access a
digital version of the agreement in the online portal.
Regulatory Analyses
Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review)
This proposed rule was developed in accordance with the principles
of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies
to assess all costs and benefits of available regulatory alternatives
and, if regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health, and safety effects; distributive impacts; and equity).
E.O. 13563 is supplemental to and reaffirms the principles, structures,
and definitions governing regulatory review established in E.O. 12866.
E.O. 12866 classifies a ``significant regulatory action,''
requiring review by the Office of Management and Budget (OMB), as any
regulatory action that is likely to result in a rule that may: (1) have
an annual effect on the economy of $100 million or more or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities; (2)
create a serious inconsistency or otherwise interfere with an action
taken or planned by another agency; (3) materially alter the budgetary
impact of entitlements, grants, user fees, or loan programs or the
rights and obligations of recipients thereof; or (4) raise novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the E.O. OMB has determined
that this proposed rule is not a ``significant regulatory action''
under E.O. 12866, section 3(f).
Analysis of Benefits and Costs
Current regulations require registrants who wish to participate in
the CSOS system to enroll using a labor-intensive manual process which
relies on paper applications. This proposed rule would amend DEA
regulations to require electronic enrollment through a secure web-based
system.
The current regulations related to CSOS enrollment are summarized
below.
(1) 21 CFR 1311.20(b)-(c) requires coordinators to enroll in
writing.
(2) 21 CFR 1311.25(a)-(b) requires a registrant, or authorized
representative with a Power of Attorney, to enroll in writing.
(3) 21 CFR 1311.40(c)-(d) requires submitting a new application in
writing for every third renewal and for expired certificates.
(4) 21 CFR 1311.60(c) requires maintaining a copy of the
subscription agreement for the life of the certificate.
The proposed rule would change this to:
(1) 21 CFR 1311.20(b)-(c) would require coordinators to enroll
online.
(2) 21 CFR 1311.25(a) (with (b) removed) would require all
registrants, or authorized representative with a Power of Attorney, to
enroll online.
(3) 21 CFR 1311.40(c)-(d) would require, for every third renewal
and expiration, a new application online.
(4) 21 CFR 1311.60(c) would be removed, allowing electronic
subscription agreements to be held online and no longer requiring a
paper copy be maintained.
Table 1 summarizes the changes from current regulations to the
proposed rule.
Table 1--Summary of Current Regulations and the Proposed Rule
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21 CFR Location Current Proposed
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1311.20(b)-(c).................. requires would require
coordinators to coordinators to
enroll in writing. enroll online.
1311.25(a)-(b).................. requires a would require all
registrant, or registrants, or
authorized authorized
representative representative
with a Power of with a Power of
Attorney, to Attorney, to
enroll in writing. enroll online.
[[Page 7036]]
1311.40(c)-(d).................. requires would require, for
submitting a new every third
application in renewal and
writing, for expiration, a new
every third application
renewal and for online.
expired
certificates.
1311.60(c)...................... requires (removal) would
maintaining a allow
copy of the subscription
subscription agreements to be
agreement. held online and
no longer require
a copy be
maintained.
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DEA has examined the benefits and costs of this proposed rule and
believes it is of net economic benefit. DEA believes the cost savings
to registrants, as well as the DEA, heavily outweigh any cost to the
DEA associated with implementing and maintaining the necessary computer
systems to allow for online enrollment and renewal to CSOS.
Affected Parties and Number of CSOS Applications
This proposed rule would affect registrants who wish to participate
in the CSOS system and DEA. A registrant, designated person, or an
authorized representative, who wishes to enroll in the CSOS system can
apply for one of three system user roles: Registrant, Coordinator, or
Power of Attorney. New and renewal enrollment applications are
submitted online. DEA processes the applications in addition to
operating and maintaining the systems used in the enrollment and
certificate management process. The economic impact of this proposed
rule is a function of changes in requirement for each CSOS enrollment
application and the estimated number of applications.
Each year DEA receives a mix of new and renewal applications for
enrollment. In 2021, DEA received 31,172 new applications. These
applications include 11,411; 6,974; and 12,787 new applications for
Registrant, Coordinator, and Power of Attorney roles, respectively. For
every third renewal, the CSOS certificate holder must submit a new
application.\13\ Therefore, for the purposes of this analysis, a third
renewal is considered as a new application. Based on this renewal
requirement, DEA estimates that new applications are approximately one-
third of total applications and the number of renewals is approximately
twice the number of new applications. Therefore, DEA estimates there
were 62,344 renewal applications for a total of 93,516 (31,172 +
62,344) total applications in 2021.
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\13\ 21 CFR 1311.40(c).
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As pharmacies are the largest registration business activity that
participate in CSOS, representing approximately 73% of CSOS registered
locations,\14\ DEA believes the growth in the number of pharmacies
registered with the DEA represents a good proxy for the growth of CSOS-
participating registrants, and the number of CSOS applications for
enrollment.
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\14\ Source: DEA.
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The number of DEA registered pharmacies has declined from 72,353 in
2015 to 70,628 in 2019 and has roughly stayed constant, with no growth,
from 2019 to 2021, with 70,789 and 70,670 pharmacy registration if 2020
and 2021, respectively. So, DEA believes that zero net growth in CSOS
applications is a reasonable estimate. Therefore, DEA estimates the
numbers of applications stay constant at 31,172 new and 62,344 renewal,
for a total of 93,516 applications over the 10-year analysis period.
Registrant Impact
New Applications
Below is a description of the estimated impact of the proposed rule
on new enrollment applications for Registrant, Coordinator, and Power
of Attorney roles.
1. Time To Complete New Application: DEA estimates there will be
labor cost savings from reduced time to complete a new application. DEA
estimates that the current time to complete a new application is three
hours, which includes an estimated 1.5 hours to prepare and provided
the necessary information and 1.5 hours calling the DEA for assistance
or status of application. Under the proposed rule, while an applicant
is expected to require the same 1.5 hours to prepare and provide the
necessary information, the online system will allow self-viewing of
status, reducing the need or duration of calls to DEA. DEA estimates
the required time to complete a new application would be 1.75 hours,
including an estimated 0.25 hours for logging to CSOS system or calls
to DEA for assistance. Using a loaded hourly rate of $87.65 for
Pharmacists,\15 16 17\ the labor cost would decrease from $262.95
($87.65 x 3) to $153.39 ($87.65 x 1.75), resulting in an estimated cost
savings of $109.56 ($262.95-$153.39) per application.
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\15\ U.S. Bureau of Labor Statistics (BLS), Occupational
Employment and Wages, May 2021, 29-1051 Pharmacists. <a href="https://www.bls.gov/oes/current/oes291051.htm">https://www.bls.gov/oes/current/oes291051.htm</a>. (Accessed 4/25/2022.)
\16\ BLS, ``Employer Costs for Employee Compensation--December
2021'' (ECEC).
\17\ As pharmacies represent a large majority of CSOS
participants and pharmacists are expected to be the most prevalent
CSOS users, DEA believes pharmacists wages therefore represent a
good estimate of the wage for all applicants. BLS reports that the
median wage of pharmacists is $61.81. BLS also reports that average
benefits for private industry is 29.5 percent of total compensation.
The 29.5 percent of total compensation equates to 41.8 percent (29.5
percent/70.5 percent) load on wages and salaries. The load of 41.8
percent is added to each of the hourly rates to estimate the loaded
hourly rates. $61.81 x 1.418 = $87.65.
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2. Postage Cost: Under current regulations paper application forms
and supporting information need to be shipped to DEA. The proposed rule
would eliminate the need to ship paper applications. Not having to ship
the enrollment package is estimated to reduce postage costs by $11.13
per application.\18\
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\18\ FedEx Ground rates for a one-pound package using zone five,
effective January 4, 2021 and downloaded on 4/6/2022.
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3. Notary Cost: Under current regulations, a new application for a
Registrant or a Coordinator role requires a notary. The proposed rule
would eliminate the notary requirement. Not having to get a notary (due
to online verification methods that are free) is expected to eliminate
an estimated notary cost of $5.00 per enrollment package.
<SUP>19 20</SUP> The notary requirement only applies to Registrant and
Coordinator roles, and as discussed earlier, of the estimated 31,172
total new applications, 11,411 and 6,974 are for Registrant and
Coordinator, respectively, making up 59 percent ((11,411 + 6,974)/
31,174) of total registrations. Therefore, 59 percent of $5.00, $2.95
is the average notary cost savings for all new applications.
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\19\ National Notary Association, ``2022 Notary Fees by State''.
<a href="https://www.nationalnotary.org/knowledge-center/about-notaries/notary-fees-by-state">https://www.nationalnotary.org/knowledge-center/about-notaries/notary-fees-by-state</a> (accessed 4/6/2022).
\20\ Notary fees can range from $1 to $25. DEA has decided to
use $5 as its estimate of notary fees. DEA believes many applicants
can get documents notarized at low costs, i.e., at banks, employees
with public notary, etc.
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4. Agreement Storage Costs: Under current regulations, a CSOS
certificate holder is required to maintain a copy of
[[Page 7037]]
the subscriber agreement. The proposed rule would eliminate this
requirement. DEA does not believe there is a material impact from not
having to store written subscription agreements and having them be
stored online in CSOS.
Table 2 summarizes the impact of the proposed rule for new
applications.
Table 2--Registrant Impact: New Application
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Cost savings
Current ($) New ($) ($)
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Labor cost per New app.......................................... 262.95 153.39 109.56
Postage cost per New app........................................ 11.13 .............. 11.13
Cost of notary per New app...................................... 2.95 .............. 2.95
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Total new application....................................... .............. .............. 123.64
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Renewal Applications
Below is a description of the estimated impact of the proposed rule
on renewal enrollment applications for Registrant, Coordinator, and
Power of Attorney roles.
1. Time Spent Requested Renewal: DEA estimates there will be labor
cost savings from reduced time to complete a renewal application. DEA
estimates that the time spent requesting a renewal will fall from 1.5
hours using the phone method to 0.25 hours using the online method.
Using a loaded hourly rate of $87.65 for Pharmacists,\21\ the labor
cost would decrease from $131.48 ($87.65 x 1.5) to $21.91 ($87.65 x
0.25), resulting in an estimated cost savings of $109.56 ($131.48-
$21.91) per application.
Table 3 summarizes the impact of the proposed rule for renewal
applications.
Table 3--Registrants Impact--Renewal Applications
----------------------------------------------------------------------------------------------------------------
Cost savings
Current ($) New ($) ($)
----------------------------------------------------------------------------------------------------------------
Labor cost per Renewal app................................... 131.48 21.91 109.56
----------------------------------------------------------------------------------------------------------------
Total Registrant Impact
The total registrant cost savings is $10,684,716 per year,
calculated by multiplying the cost of a new and renewal application by
the number of new and renewal applications. Table 4 details the
calculation.
Table 4--Total Registrant Impact
------------------------------------------------------------------------
------------------------------------------------------------------------
Number of new applications.............................. 31,172
Number of renewal applications.......................... 62,344
Number of total applications............................ 93,516
Cost savings per new application ($).................... 123.64
---------------
Subtotal, all new applications ($).................. 3,854,152
Cost savings per renewal application ($)................ 109.56
---------------
Subtotal, all renewal applications ($).............. 6,830,565
---------------
Total cost savings to registrants ($)........... 10,684,716
------------------------------------------------------------------------
Additional Benefits
There are additional benefits of the proposed rule. These include:
(1) Shorter end-to-end process time (submission to certificate):
Allowing earlier use of CSOS for ordering Schedule II controlled
substances and realizing the benefits of electronic ordering rather
than using paper order forms.
(2) Insight into status and workflows to track the progress of the
submission: Allowing Coordinators to get status updates online, see how
the application progresses, and plan for additional CSOS users.
---------------------------------------------------------------------------
\21\ Note 17.
---------------------------------------------------------------------------
(3) No longer needing to wait for the call center to request
Certificate management action revocations: Allowing Coordinators to
self-manage and remove user certificates.
(4) Safer submission process: Allowing secure delivery of
potentially sensitive information.
(5) Error checking: Allowing programmatic review for erroneous or
incomplete information, reducing delays in application processing.
DEA Impact
DEA's costs are driven by the personnel and technology resources
required to process the applications. Below is a list of the cost
activities and anticipated impact.
1. Certification Authority (CA) Cost: The CA serves as the central
element responsible for establishing a trust relationship between
controlled substance manufacturers, distributors, pharmacies, and other
DEA authorized ordering entities. CA issues user digital certificates
used to digitally sign electronic transactions. DEA believes that the
personnel resources and costs to certify enrollment and issue digital
certificates will not change as a result of this proposed rule. Based
on current CA resources, DEA estimates the annual CA cost will remain
at $732,922.\22\
---------------------------------------------------------------------------
\22\ Source: DEA.
---------------------------------------------------------------------------
[[Page 7038]]
2. Registration Authority (RA) Cost: The RA is the entity that
collects and verifies each applicant's identity and information that
are to be entered into his or her public key certificates. Receiving
electronic applications would eliminate the need to scan paper
applications. DEA estimates that the personnel resources and costs to
process enrollment applications will fall by 30 percent starting with
the second year of implementation of the rule. However, in the first
year of implementation, DEA anticipates the decrease in resource
requirements from elimination of scanning requirement will be offset by
increase in applicant questions referred to RA. DEA estimates the total
annual RA cost of $597,688 \23\ will remain the same in year 1 and will
be $418,382 ($597,688 x 0.7) in year 2 and thereafter.
---------------------------------------------------------------------------
\23\ Source: DEA.
---------------------------------------------------------------------------
3. Mail Reception Cost: Currently, DEA requires personnel to
receive, sort, and deliver paper applications to the RA at an estimated
annual cost of $34,562.\24\ Under the proposed rule, applications would
be received online, eliminating this cost.
---------------------------------------------------------------------------
\24\ Source: DEA.
---------------------------------------------------------------------------
4. Data Entry Cost: Currently, personnel resources are needed to
verify the accuracy of the scanned paper applications and make any
needed corrections. Under the proposed rule, online applications would
eliminate the need for this task. The estimated total current annual
cost of $109,138 \25\ would be eliminated if this proposed rule were
implemented.
---------------------------------------------------------------------------
\25\ Source: DEA.
---------------------------------------------------------------------------
5. Call Center Support Cost: DEA operates a CSOS call center to
service questions, or provide assistance, regarding CSOS enrollment and
certificate management. The estimated total current annual cost as
$1,749,946.\26\ While DEA anticipates a reduction in the number of
calls and duration of each call, DEA anticipates this reduction will
result in lower wait-times for callers rather than reduced call center
resources. Therefore, DEA estimates this cost will remain the same at
$1,749,946.
---------------------------------------------------------------------------
\26\ Source: DEA.
---------------------------------------------------------------------------
6. Information Technology (IT) Cost: DEA currently spends
approximately $255,000 per year on its IT enrollment-related systems
and software. DEA anticipates IT costs will increase to $2,935,200 per
year.\27\ IT cost includes, but are not limited to, cloud services,
workflow management, identity verification, identity management
functionality, professional services for continuous development,
integration and deployment, and maintenance and troubleshooting.
---------------------------------------------------------------------------
\27\ Source: DEA.
---------------------------------------------------------------------------
All costs are expected to scale with the volume of new
applications, except IT cost, which does not vary with the volume of
applications. Table 5 summarizes the DEA's impact.
Table 5--Total DEA Impact
[Initial and remaining years]
----------------------------------------------------------------------------------------------------------------
Year 1, Year 2,
Current ($) Year 1 ($) change from Year 2 * ($) change from
current ($) current ($)
----------------------------------------------------------------------------------------------------------------
Number of applications.......... 31,172 31,172 .............. 31,172 ..............
Certificate Authority........... 732,992 732,992 .............. 418,382 -314,610
Registration Authority **....... 597,688 418,382 -179,306 418,382 -179,306
Mail preparation (received mail) 34,562 .............. -34,562 .............. -34,562
Data Entry...................... 109,138 .............. -109,138 .............. -109,138
Call Center Support............. 1,749,946 1,749,946 .............. 1,749,946 ..............
Information Technology.......... 255,000 2,935,200 2,680,200 2,935,200 2,680,200
-------------------------------------------------------------------------------
Total cost.................. 3,479,325 5,836,519 2,357,194 5,521,909 2,042,584
----------------------------------------------------------------------------------------------------------------
* Years 2 through 10 are all assumed to be the same.
** New cost starts on second year.
Additional Benefits
There are additional benefits to the DEA from the proposed rule.
These include:
(1) That the CSOS System will be supported, secure, reliable, and
scalable: Reducing the risk of lost or stolen data and long-term
reduction in costs associated with to maintenance, operations, and
growth.
(2) The Certificate management process no longer involves a help
desk call: Call center resources will be freed up to reduce hold-times
for registrants allowing meeting call management service level
agreements and improving user satisfaction.
(3) Possible increase in CSOS adoption due to ease of enrollment
process: Reducing DEA costs associated with printing and mailing paper
order forms.
(4) The ease at which enhancements can be made as needed, for
example Enterprise Certificates with multiple DEA numbers: Allowing
efficient future improvements to CSOS.
Registrant and DEA Total Impact
Using the registrant and DEA impacts from table 5 the estimated net
cost savings of this proposed rule for the 10-year analysis period is
listed in Table 8.
Table 6--DEA and Registrant Total Impact
----------------------------------------------------------------------------------------------------------------
Total cost Net cost Total net
savings to savings to DEA cost savings,
Year registrants (net cost) registrant +
($) ($) DEA ($)
----------------------------------------------------------------------------------------------------------------
1............................................................... 10,684,716 (2,536,501) 8,148,216
2............................................................... 10,684,716 (2,357,194) 8,327,522
[[Page 7039]]
3............................................................... 10,684,716 (2,357,194) 8,327,522
4............................................................... 10,684,716 (2,357,194) 8,327,522
5............................................................... 10,684,716 (2,357,194) 8,327,522
6............................................................... 10,684,716 (2,357,194) 8,327,522
7............................................................... 10,684,716 (2,357,194) 8,327,522
8............................................................... 10,684,716 (2,357,194) 8,327,522
9............................................................... 10,684,716 (2,357,194) 8,327,522
10.............................................................. 10,684,716 (2,357,194) 8,327,522
----------------------------------------------------------------------------------------------------------------
The present value of the net cost savings over the 10-year analysis
period is $70,861,367 and $58,321,453 at three and seven percent
discount rates, respectively. The annualized net benefit is $8,307,114
and $8,303,663 at three and seven percent, respectively.
Executive Order 12988, Civil Justice Reform
This proposed rule meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform to
eliminate ambiguity, minimize litigation, establish clear legal
standards, and reduce burdens. DEA expects the instant validation of
online registration applications to reduce ambiguity and reduce the
number of errors in submissions and reduce burdens on both DEA and
registrants.
Executive Order 13132, Federalism
This proposed rule does not have federalism implications warranting
the application of E.O. 13132. The proposed rule does not have
substantial direct effects on the States, on the relationship between
the National government and the States, or on the distribution of power
and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
The proposed rule does not have substantial direct effects on one
or more Indian tribes, on the relationship between the Federal
government and Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.
Regulatory Flexibility Act
In accordance with the Regulatory Flexibility Act (RFA), the DEA
has reviewed the economic impact of this proposed rule on small
entities. DEA's economic impact evaluation indicates that the rule will
not, if promulgated, have a significant economic impact on a
substantial number of small entities.
The RFA requires an agency to analyze options for regulatory relief
of small entities unless it can certify that the rule will not have a
significant impact on substantial number of small entities. DEA has
analyzed the economic impact of each provision of this proposed rule
and estimates that it will have minimal economic impact on affected
entities, including small businesses, nonprofit organizations, and
small governmental jurisdictions.
This proposed rule will simplify the enrollment process by
requiring all initial registration and renewal applications be
submitted online. The rule would affect all enrollment and renewals for
CSOS, whose users currently use paper applications. However, once a
registrant is enrolled the DEA already requires them to order using
CSOS. So, there is no additional cost to obtaining access to CSOS,
since registrants will already be required to use it eventually.
There is a total of 94,011 CSOS participating entities, as can be
seen in Table 7, with approximately 325,000 active certificates.
Certificates have to be renewed every one or three years, based on the
registrants' DEA registration renewal cycle. In 2021, the number of new
applications were 31,172. For every third renewal, the CSOS certificate
holder must submit a new application.\28\ Therefore, for the purposes
of this analysis, a third renewal is considered as a new application.
DEA estimate that the total applications, including renewals, is
93,516.
---------------------------------------------------------------------------
\28\ 21 CFR 1311.40(c).
Table 7--Percentage and Number of Registered Locations by Business Activity
----------------------------------------------------------------------------------------------------------------
Number of Renewal cycle
Business activity entities Percent (years)
----------------------------------------------------------------------------------------------------------------
Pharmacy........................................................ 62,291 66.26 3
Hospital/Clinic................................................. 11,898 12.66 3
Practitioner/Mid-Level Practitioner (MLP)....................... 18,095 19.25 3
Teaching Institution............................................ 14 0.01 3
Manufacturer.................................................... 103 0.11 1
Distributor/Importer/Exporter................................... 444 0.47 1
Researcher...................................................... 247 0.26 1
Analytical Lab.................................................. 26 0.03 1
Reverse Distributor............................................. 5 0.01 1
Narcotic Treatment Program (NTP)................................ 888 0.94 1
-----------------------------------------------
Total........................................................... 94,011 100.00 * 2.97
----------------------------------------------------------------------------------------------------------------
* Weighted average.
(Source: DEA).
[[Page 7040]]
This proposed rule affects all new and renewal enrollment
applications for CSOS, as applications will have to take place online,
and all entities who would submit new and renewal applications. This
proposed rule would affect small entities in industries associated with
the above business activities, primarily industries associated with
pharmacy, hospital/clinic, and practitioner/MLP registrations, as these
business activities make up 98.17% of the CSOS-participating
registrations. Table 8 indicates the sectors, as defined by the North
American Industry Classification System (NAICS), that best correlate
with business activities affected by the proposed rule.
Table 8--Industrial Sectors Affected by the Proposed Rule
------------------------------------------------------------------------
Business activity NAICS code NAICS code description
------------------------------------------------------------------------
Pharmacy......................... 445110 Supermarkets and Other
Grocery (except
Convenience) Stores.
446110 Pharmacies and Drug
Stores.
452210 Department Stores.
452311 Warehouse Clubs and
Supercenters.
NTP, Hospital/Clinic, 621111 Offices of Physicians
Practitioner, MLP*. (except Mental Health
Specialists).
621112 Offices of Physicians,
Mental Health
Specialists.
621330 Offices of Mental Health
Practitioners (except
Physicians).
621420 Outpatient Mental Health
and Substance Abuse
Centers.
621491 HMO Medical Centers.
621493 Freestanding Ambulatory
Surgical and Emergency
Centers.
622110 General Medical and
Surgical Hospitals.
622210 Psychiatric and
Substance Abuse
Hospitals.
622310 Specialty (except
Psychiatric and
Substance Abuse)
Hospitals.
Teaching Institute............... 611310 Colleges, Universities
and Professional
Schools.
Manufacturer..................... 325411 Medicinal and Botanical
Manufacturing.
325412 Pharmaceutical
Preparation
Manufacturing.
Distributor, Importer, Exporter.. 424210 Drugs and Druggists'
Sundries Merchant
Wholesalers.
Researcher....................... 541715 Research and Development
in the Physical,
Engineering, and Life
Sciences (except
Nanotechnology and
Biotechnology).
Analytical Labs.................. 541380 Testing Laboratories.
Reverse Distributor.............. 562213 Solid Waste Combustors
and Incinerators.
562219 Other Nonhazardous Waste
Treatment and Disposal.
------------------------------------------------------------------------
* Practitioners and mid-level practitioners are generally employed in
one of these industries.
As shown in Table 8, the proposed rule would affect a wide variety
of entities across many industry sectors. Some industry sectors are
expected to consist primarily of DEA CSOS registrants (i.e., 446110--
Pharmacies and Drug Stores, 622110--General Medical and Surgical
Hospitals, etc.). Therefore, this proposed rule is expected to affect a
substantial number of small entities in some industries.
There are no new costs associated with this proposed rule. The
labor burden to submit an application is estimated to be the same for
electronic and paper submissions. All CSOS registered location will
already need to have access to the internet in order to use CSOS. DEA
acknowledges some applicants prefer paper forms. DEA does not have a
basis to quantify this preference; however, DEA believes any costs
associated with eliminating this preference is offset by the cost
savings discussion below.
DEA anticipates there will be cost savings associated with
electronic submissions. Some cost savings are described qualitatively
and some are quantified. Many paper applications submitted contain
illegible or erroneous information or omit required information. Many
such errors or omissions, such as not including a signature or paying
the wrong amount, require DEA to contact applicants to correct or
clarify the information in the paper form, consuming DEA's and the
applicant's time and resources. Electronic submissions are expected to
virtually eliminate the requirement for DEA to contact applicants for
clarifications of form data or correction of submission errors, as
validation features in the system will flag common errors prior to
transmission. As DEA has not tracked the number of delays or the
duration of such delays, DEA does not have a basis to quantify the cost
savings.
Furthermore, this proposed rule would eliminate the need to print
paper forms and transmit by mail or courier service, generating an
estimated cost savings of $11.13 per each paper application not
submitted.\29\ DEA assumes the cost savings associated with eliminating
printing costs and envelopes is negligible. This proposed rule would
also eliminate the need to get a notary for new applications, which
will save $5.00 each for applications for registrant and coordinator
roles.\30\ An application for POA role does not require a notary; and
while there would be no notary cost savings for these applications, $5
cost savings is included in the analysis to be conservative and because
applications for registrant and coordinator roles are slightly more
than half of all applications.
---------------------------------------------------------------------------
\29\ Note 18.
\30\ Note 20.
---------------------------------------------------------------------------
As discussed in the E.O. 12866 section above, DEA estimates that
the time savings from this proposed rule will save $109.56 per new and
renewal application.
Total cost savings for a new application is $125.69 (109.56 + 11.13
+ 5.00 = 125.69), as can be seen in Table 9.
[[Page 7041]]
Table 9--Cost Savings per New Application
----------------------------------------------------------------------------------------------------------------
Cost savings
Current ($) New ($) ($)
----------------------------------------------------------------------------------------------------------------
Labor cost per New app.......................................... 262.95 153.39 109.56
Postage cost per app............................................ 11.13 .............. 11.13
Cost of notary.................................................. 5.00 .............. 5.00
-----------------------------------------------
Total....................................................... .............. .............. 125.69
----------------------------------------------------------------------------------------------------------------
As also calculated in the E.O. 12866 section above, total cost
savings for renewals is $109.56, as can be seen in Table 10.
Table 10--Cost Savings Per Renewal Application
----------------------------------------------------------------------------------------------------------------
Cost savings
Current ($) New ($) ($)
----------------------------------------------------------------------------------------------------------------
Labor cost per Renewal app...................................... 131.48 21.91 109.56
-----------------------------------------------
Total....................................................... .............. .............. 109.56
----------------------------------------------------------------------------------------------------------------
There were 31,172 new applications in 2021. DEA estimates there
were also 62,344 renewal applications for a total of 93,516
applications. Given there are 94,011 CSOS participating entities, there
is less than one application per year per entity on average (93,516/
94,011 = 0.99). Given that there are at approximately 325,000 active
digital certificates, the vast majority of which are on three-year
renewal cycles, DEA expects approximately 108,333 certificates to be
renewed annually (325,000/3 = 108,333). There are then approximately
1.15 certificates per entity (108,333/94,011 = 1.15). Given that
smaller firms should have less certificates than larger firms, DEA
believes using one certificate or one application per entity per year
is a reasonable assumption for the smallest of small entities.
To determine whether the proposed rule would have a significant
economic impact on small entities, DEA conducted a revenue test by
comparing the estimated annual cost savings to the average annual
revenue for the smallest of small entities in industries affected by
the proposed rule. Based on the Statistics of U.S. Businesses data from
the Census Bureau, table 11 lists the enterprise size, number of
establishments, and the average annual revenue for the smallest of
small businesses in each industry sector.\31 32\
---------------------------------------------------------------------------
\31\ Census Bureau, Statistics of U.S. Businesses Revenue Data
by Size, 2017. <a href="https://www.census.gov/programs-surveys/susb.html">https://www.census.gov/programs-surveys/susb.html</a>.
(Released 5/28/2021).
\32\ Census Bureau, Statistics of U.S. Businesses Number of
Establishment Data by Size, 2019. <a href="https://www.census.gov/programs-surveys/susb.html">https://www.census.gov/programs-surveys/susb.html</a>. (Released 2/11/2022).
Table 11--Average Annual Revenue of Smallest of Small Entities
----------------------------------------------------------------------------------------------------------------
Enterprise size Average revenue
NAICS NAICS description (number of Number of per establishment
employees) establish-ments ($ thousands)
----------------------------------------------------------------------------------------------------------------
325411................ Medicinal and Botanical 0-4 239 690
Manufacturing.
325412................ Pharmaceutical Preparation 0-4 390 1,173
Manufacturing.
424210................ Drugs and Druggists' Sundries 0-4 4,076 1,512
Merchant Wholesalers.
445110................ Supermarkets and Other Grocery 0-4 20,741 519
(except Convenience) Stores.
446110................ Pharmacies and Drug Stores..... 0-4 7,052 1,328
452210................ Department Stores.............. 0-4 3 467
452311................ Warehouse Clubs and 0-4 20 475
Supercenters.
541380................ Testing Laboratories........... 0-4 2,427 316
541715................ Research and Development in the 0-4 4,895 449
Physical, Engineering, and
Life Sciences (except
Nanotechnology and
Biotechnology).
562213................ Solid Waste Combustors and 0-4 15 949
Incinerators.
562219................ Other Nonhazardous Waste 0-4 183 580
Treatment and Disposal.
611310................ Colleges, Universities, and 0-4 458 802
Professional Schools.
621111................ Offices of Physicians (except 0-4 91,892 465
Mental Health Specialists).
621112................ Offices of Physicians, Mental 0-4 9,031 291
Health Specialists.
621330................ Offices of Mental Health 0-4 22,653 165
Practitioners (except
Physicians).
621420................ Outpatient Mental Health and 0-4 3,019 248
Substance Abuse Centers.
621491................ HMO Medical Centers............ 0-4 27 98
621493................ Freestanding Ambulatory 0-4 1,188 666
Surgical and Emergency Centers.
622110................ General Medical and Surgical 0-4 79 15,559
Hospitals.
622210................ Psychiatric and Substance Abuse 0-4 10 1,024
Hospitals.
622310................ Specialty (except Psychiatric 0-4 8 1,965
and Substance Abuse) Hospitals.
----------------------------------------------------------------------------------------------------------------
[[Page 7042]]
The estimated cost savings of $125.69 for new applications and
$109.56 for renewal applications were compared to the average annual
revenue for each of the NAICS codes in Table 11. For example, taking
the smallest possible entities, HMO Medical Centers with 0-4 people,
with an average revenue of $98,000, the benefit, in the form of cost
savings, from new applications is $125.69 (109.56 + 11.13 + 5 =
125.69), or 0.13 percent of revenues (125.69/98,000 = 0.0013). The
benefit from renewals is 0.11 percent of revenues (109.56/98,000 =
0.0011). Table 12 details the revenue test results for all affected
NAICS codes.
Table 12--Revenue Test of Smallest of Small Entities
----------------------------------------------------------------------------------------------------------------
Benefit from Benefit from
NAICS Average revenue new Percent of renewal Percent of
NAICS description per establishment applications revenue (%) applications revenue (%)
($ thousands) ($) ($)
----------------------------------------------------------------------------------------------------------------
325411...... Medicinal and 690 125.69 0.02 109.56 0.02
Botanical
Manufacturing.
325412...... Pharmaceutical 1,173 125.69 0.01 109.56 0.01
Preparation
Manufacturing.
424210...... Drugs and 1,512 125.69 0.01 109.56 0.01
Druggists'
Sundries
Merchant
Wholesalers.
445110...... Supermarkets 519 125.69 0.02 109.56 0.02
and Other
Grocery
(except
Convenience)
Stores.
446110...... Pharmacies and 1,328 125.69 0.01 109.56 0.01
Drug Stores.
452210...... Department 467 125.69 0.03 109.56 0.02
Stores.
452311...... Warehouse Clubs 475 125.69 0.03 109.56 0.02
and
Supercenters.
541380...... Testing 316 125.69 0.04 109.56 0.03
Laboratories.
541715...... Research and 449 125.69 0.03 109.56 0.02
Development in
the Physical,
Engineering,
and Life
Sciences
(except
Nanotechnology
and
Biotechnology).
562213...... Solid Waste 949 125.69 0.01 109.56 0.01
Combustors and
Incinerators.
562219...... Other 580 125.69 0.02 109.56 0.02
Nonhazardous
Waste
Treatment and
Disposal.
611310...... Colleges, 802 125.69 0.02 109.56 0.01
Universities,
and
Professional
Schools.
621111...... Offices of 465 125.69 0.03 109.56 0.02
Physicians
(except Mental
Health
Specialists).
621112...... Offices of 291 125.69 0.04 109.56 0.04
Physicians,
Mental Health
Specialists.
621330...... Offices of 165 125.69 0.08 109.56 0.07
Mental Health
Practitioners
(except
Physicians).
621420...... Outpatient 248 125.69 0.05 109.56 0.04
Mental Health
and Substance
Abuse Centers.
621491...... HMO Medical 98 125.69 0.13 109.56 0.11
Centers.
621493...... Freestanding 666 125.69 0.02 109.56 0.02
Ambulatory
Surgical and
Emergency
Centers.
622110...... General Medical 15,559 125.69 0.00 109.56 0.00
and Surgical
Hospitals.
622210...... Psychiatric and 1,024 125.69 0.01 109.56 0.01
Substance
Abuse
Hospitals.
622310...... Specialty 1,965 125.69 0.01 109.56 0.01
(except
Psychiatric
and Substance
Abuse)
Hospitals.
----------------------------------------------------------------------------------------------------------------
As shown in Table 12, the revenue test for the smallest of small
entities (0-4 employees) ranges from 0.00 percent with rounding for
NAICS code 622110 to 0.13 percent for NAICS code 621491. Therefore, the
economic impact of this proposed rule is not significant for the
smallest of small entities, and the economic impact is estimated to be
not significant on any small entity.
In conclusion, while the proposed rule will impact a substantial
number of small entities in at least some industries, the economic
impact will not be significant. Therefore, this proposed rule, if
promulgated, will not have a significant economic impact on a
substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act of 1995
(UMRA),\33\ DEA has determined that this action would not result in any
Federal mandate that may result ``in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any 1 year.''
Therefore, neither a Small Government Agency Plan nor any other action
is required under the UMRA.
---------------------------------------------------------------------------
\33\ 2 U.S.C. 1501 et seq.
---------------------------------------------------------------------------
Paperwork Reduction Act
This proposed rule would modify existing collection(s) of
information requirement under the Paperwork Reduction Act (PRA).\34\
The proposed rule will combine all information collection into one on-
line enrollment process eliminating the need for individual forms.
Pursuant to the PRA,\35\ DEA has identified the collections of
information below related to this proposed rule. A person is not
required to respond to a collection of information unless it displays a
valid OMB control number.\36\
---------------------------------------------------------------------------
\34\ 44 U.S.C. 3501-3521.
\35\ 44 U.S.C. 3507(d).
\36\ Copies of existing information collections approved by OMB
may be obtained at <a href="http://www.reginfo.gov/public/do/PRAMain">http://www.reginfo.gov/public/do/PRAMain</a>.
---------------------------------------------------------------------------
A. Collections of Information Associated With the Proposed Rule
1. Title: CSOS Certificate Application.
OMB Control Number: 1117-0038.
[[Page 7043]]
Form Number: DEA-251.
DEA is proposing to amend its regulations to require that all CSOS
applications and supporting materials must be submitted to DEA through
the DEA Diversion Control Division secure network application. This
amendment would improve the submission process by aligning it with
DEA's current requirements for other online form submissions. The
online submission of applications and supporting material through the
secure database will ensure DEA's receipt of documentation in a more
timely and organized manner. This combined online form will be used for
all CSOS user roles: DEA Registrant, Principal Coordinator/Alternate
Coordinator, and Power of Attorney.
DEA estimates the following number of respondents and burden
associated with this collection of information:
<bullet> Number of respondents: 94,011.
<bullet> Frequency of response: 0.994735 (as needed,
calculated).\37\
---------------------------------------------------------------------------
\37\ Calculated by dividing the number of responses (93,516) by
the number of respondents (94,011).
---------------------------------------------------------------------------
<bullet> Number of responses: 93,516.
<bullet> Burden per response: 0.75.\38\
---------------------------------------------------------------------------
\38\ Weighted average of new and renewal applications. There are
31,172 new applications and they take 1.75 hours. There are 62,344
renewals and they take 0.25 hours. New applications represent 33
percent of applications (31,172/93,516 = 0.33) and renewals
represent 67 percent of applications (62,344/93,516 = 0.67). The
weighted average is then 0.75 ([0.33 x 1.75] + [0.67 * 0.25] =
0.75).
---------------------------------------------------------------------------
<bullet> Total annual hour burden: 70,137.
Written comments and suggestions from the public and affected
entities concerning the proposed collections of information are
encouraged. Under the PRA, DEA is required to provide a notice
regarding the proposed collections of information in the FR with the
notice of proposed rulemaking and solicit public comment. Pursuant to
the PRA,\39\ DEA solicits comments on the following issues:
---------------------------------------------------------------------------
\39\ 44 U.S.C. 3506(c)(2).
---------------------------------------------------------------------------
<bullet> Whether the proposed collection of information is
necessary for the proper performance of the functions of DEA, including
whether the information will have practical utility.
<bullet> The accuracy of DEA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used.
<bullet> Recommendations to enhance the quality, utility, and
clarity of the information to be collected.
<bullet> Recommendations to minimize the burden of the collection
of information on those who are to respond, including through the use
of automated collection techniques or other forms of information
technology.
All comments concerning collections of information under the PRA
must be submitted to the Office of Information and Regulatory Affairs,
OMB, Attention: Desk Officer for the Department of Justice, Washington,
DC 20503. Please state that your comments refer to RIN 1117-AB79/Docket
No. DEA-732. All comments must be submitted to OMB on or before April
3, 2023. The final rule will respond to any OMB or public comments on
the information collection requirements contained in this proposed
rule.
If you need a copy of the proposed information collection
instrument(s) with instructions or additional information, please
contact the Regulatory Drafting and Policy Support Section (DPW),
Diversion Control Division, Drug Enforcement Administration; Mailing
Address: 8701 Morrissette Drive, Springfield, Virginia 22152;
Telephone: (571) 362-3261.
List of Subjects in 21 CFR Part 1311
Administrative practice and procedure, Control substances, Drug
traffic control, Prescription drugs, Reporting and recordkeeping
requirements.
For the reasons stated in the preamble, DEA proposes to amend 21
CFR part 1311 as follows:
PART 1311--REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS
0
1 The authority citation for part 1311 continues to read as follows:
Authority: 21 U.S.C. 821, 828, 829, 871(b), 958(e), 965, unless
otherwise noted.
0
2. Amend Sec. 1311.20 by revising paragraphs (b) and (c) to read as
follows:
Sec. 1311.20 Coordinators for CSOS digital certificate holders.
* * * * *
(b) If the designated coordinator changes at any time, the
Certification Authority must immediately be notified of the change and
the new responsibilities assumed by each of the registrant's
coordinators, if applicable. New Coordinators must complete the online
application as provided in Sec. 1311.25.
(c) The registrant's coordinator must inform the Certification
Authority of all digital certificate applications, renewals and
revocations for the registrant's users and approve applicants applying
for a power of attorney digital certificate for a DEA registrant by
means instructed by the Certification Authority within the system.
0
3. Revise Sec. 1311.25 to read as follows:
Sec. 1311.25 Requirements for obtaining a CSOS digital certificate.
(a) To obtain a certificate to use for signing electronic orders
for controlled substances, a registrant, coordinator, or person with
power of attorney authorized to obtain a certificate for signing
electronic orders for controlled substances for a registrant must
complete the online enrollment process at <a href="http://www.deaecom.gov">www.deaecom.gov</a> by:
(1) Completing the online identification proofing process;
(2) Providing a current listing of DEA registrations for which the
individual has authority to sign controlled substances orders.
(3) Uploading all copies of the power of attorney forms authorized
by the registrant, when applicable.
(4) Acknowledging that the applicant has read and understands the
Subscriber Agreement and agrees to all terms contained in the Statement
of Subscriber Obligations contained online.
(b) When the Certification Authority verifies the applicant's
identity and employment and approves the application, it will send the
applicant a one-time use reference number and access code, via separate
channels, and information on how to use them. Using this information,
the applicant must then electronically submit a request for
certification of the public digital signature key. After the request is
approved, the Certification Authority will provide the applicant with
the signed public key certificate.
(c) Once the applicant has generated the key pair, the
Certification Authority must prove that the user has possession of the
key. For public keys, the corresponding private key must be used to
sign the certificate request. Verification of the signature using the
public key in the request will serve as proof of possession of the
private key.
0
4. Amend Sec. 1311.40 by revising paragraphs (c) and (d) to read as
follows:
Sec. 1311.40 Renewal of CSOS digital certificates.
* * * * *
(c) If a CSOS certificate holder applies for a renewal before the
certificate expires, the certificate holder may renew online at
<a href="http://www.deaecom.gov">www.deaecom.gov</a> twice. For every third renewal, the CSOS certificate
holder must submit a new application and documentation, as provided in
Sec. 1311.25.
(d) If a CSOS certificate expires before the holder applies for a
renewal, the certificate holder must submit a new application and all
required documentation, as provided in Sec. 1311.25.
[[Page 7044]]
Sec. 1311.60 [Amended]
0
5. Amend Sec. 1311.60 by removing paragraph (c).
Signing Authority
This document of the Drug Enforcement Administration was signed on
January 24, 2023, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-01804 Filed 2-1-23; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on February 2, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.