Controlled Substances Ordering System (CSOS) Modernization, 7033-7044 [2023-01804]
Download as PDF
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules
(2) Recommendation Not to Board. If
CBP is unable to validate a passenger’s
travel documents, CBP will recommend
that the carrier not board the passenger.
*
*
*
*
*
Alejandro N. Mayorkas,
Secretary, U.S. Department of Homeland
Security.
[FR Doc. 2023–02139 Filed 2–1–23; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1311
[Docket No. DEA–732]
RIN 1117–AB79
Controlled Substances Ordering
System (CSOS) Modernization
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
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.
• Electronic comments: The Drug
Enforcement Administration (DEA)
khammond on DSKJM1Z7X2PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
20:39 Feb 01, 2023
Jkt 259001
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 https://
www.regulations.gov 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 Regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
submitted and there is no need to
resubmit the same comment.
• 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 https://
www.regulations.gov. 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
PO 00000
Frm 00022
Fmt 4702
Sfmt 4702
7033
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 https://
www.regulations.gov 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 https://
www.regulations.gov 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
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
1 21
U.S.C. 958(f).
CFR 0.100(b).
3 21 U.S.C. 802(11).
2 28
E:\FR\FM\02FEP1.SGM
02FEP1
7034
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules
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
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
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
khammond on DSKJM1Z7X2PROD with PROPOSALS
4 21
U.S.C. 828(a).
5 21 U.S.C. 828(c)(2).
6 21 U.S.C. 828(d)(1).
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.
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,’’
VerDate Sep<11>2014
17:12 Feb 01, 2023
Jkt 259001
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.
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 deadiversion.gov website to the
CSOS log-in page. From the CSOS login page the applicant will be redirected
to Login.gov for Identification
Verification. Upon arrival at the site, the
applicant will be asked to create a
Login.gov account by entering a valid
email address, selecting a default
language, and agreeing to Login.gov’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
Login.gov 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 Login.gov website, the
applicant must agree to the site’s
published in the Federal Register on April 1, 2005,
at 70 FR 16901.
11 21 CFR part 1311 et seq.
PO 00000
Frm 00023
Fmt 4702
Sfmt 4702
security statement. Login.gov next
requires applicants to upload
photographs of one or more forms of
identification as specified by Login.gov
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
Login.gov 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.
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,
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), https://www.reginfo.gov/public/do/
eAgendaMain?operation=OPERATION_GET_
AGENCY_RULE_LIST¤tPub=
true&agencyCode=&showStage=active&agencyCd=
1100&csrf_token=F19C7C599C70B80C228EC16B
60AEB150F6339AF3C80E56FE003EEB7D3
A758895BC8E16A215E8A0466326EBFBA8639
F799E09 (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).
E:\FR\FM\02FEP1.SGM
02FEP1
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules
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.
khammond on DSKJM1Z7X2PROD with PROPOSALS
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 § 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 § 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
§ 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
§ 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,
7035
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
21 CFR Location
Current
Proposed
1311.20(b)–(c) .................................
1311.25(a)–(b) .................................
requires coordinators to enroll in writing ...................
requires a registrant, or authorized representative
with a Power of Attorney, to enroll in writing.
would require coordinators to enroll online.
would require all registrants, or authorized representative with a Power of Attorney, to enroll online.
VerDate Sep<11>2014
17:12 Feb 01, 2023
Jkt 259001
PO 00000
Frm 00024
Fmt 4702
Sfmt 4702
E:\FR\FM\02FEP1.SGM
02FEP1
7036
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules
TABLE 1—SUMMARY OF CURRENT REGULATIONS AND THE PROPOSED RULE—Continued
21 CFR Location
Current
Proposed
1311.40(c)–(d) .................................
requires submitting a new application in writing, for
every third renewal and for expired certificates.
requires maintaining a copy of the subscription
agreement.
would require, for every third renewal and expiration, a new application online.
(removal) would allow subscription agreements to
be held online and no longer require a copy be
maintained.
1311.60(c) .......................................
khammond on DSKJM1Z7X2PROD with PROPOSALS
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.
As pharmacies are the largest
registration business activity that
participate in CSOS, representing
approximately 73% of CSOS registered
13 21
CFR 1311.40(c).
VerDate Sep<11>2014
17:12 Feb 01, 2023
Jkt 259001
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.
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 selfviewing 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
14 Source:
DEA.
Bureau of Labor Statistics (BLS),
Occupational Employment and Wages, May 2021,
29–1051 Pharmacists. https://www.bls.gov/oes/
current/oes291051.htm. (Accessed 4/25/2022.)
16 BLS, ‘‘Employer Costs for Employee
Compensation—December 2021’’ (ECEC).
15 U.S.
PO 00000
Frm 00025
Fmt 4702
Sfmt 4702
labor cost would decrease from $262.95
($87.65 × 3) to $153.39 ($87.65 × 1.75),
resulting in an estimated cost savings of
$109.56 ($262.95¥$153.39) per
application.
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
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. 19 20 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.
4. Agreement Storage Costs: Under
current regulations, a CSOS certificate
holder is required to maintain a copy of
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 × 1.418 = $87.65.
18 FedEx Ground rates for a one-pound package
using zone five, effective January 4, 2021 and
downloaded on 4/6/2022.
19 National Notary Association, ‘‘2022 Notary
Fees by State’’. https://www.nationalnotary.org/
knowledge-center/about-notaries/notary-fees-bystate (accessed 4/6/2022).
20 Notary fees can range from $1 to $25. DEA has
decided to use $5 as its estimate of notary fees. DEA
believes many applicants can get documents
notarized at low costs, i.e., at banks, employees
with public notary, etc.
E:\FR\FM\02FEP1.SGM
02FEP1
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules
the subscriber agreement. The proposed
rule would eliminate this requirement.
DEA does not believe there is a material
impact from not having to store written
subscription agreements and having
them be stored online in CSOS.
7037
Table 2 summarizes the impact of the
proposed rule for new applications.
TABLE 2—REGISTRANT IMPACT: NEW APPLICATION
Current
($)
New
($)
Cost savings
($)
Labor cost per New app ..............................................................................................................
Postage cost per New app ..........................................................................................................
Cost of notary per New app ........................................................................................................
262.95
11.13
2.95
153.39
........................
........................
109.56
11.13
2.95
Total new application ............................................................................................................
........................
........................
123.64
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 ×
1.5) to $21.91 ($87.65 × 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
Labor cost per Renewal app .......................................................................................................
Total Registrant Impact
The total registrant cost savings is
$10,684,716 per year, calculated by
multiplying the cost of a new and
renewal application by the number of
Current
($)
New
($)
Cost savings
($)
131.48
21.91
109.56
new and renewal applications. Table 4
details the calculation.
TABLE 4—TOTAL REGISTRANT IMPACT
Number of new applications ................................................................................................................................................................
Number of renewal applications ..........................................................................................................................................................
Number of total applications ................................................................................................................................................................
Cost savings per new application ($) ..................................................................................................................................................
31,172
62,344
93,516
123.64
Subtotal, all new applications ($) .................................................................................................................................................
Cost savings per renewal application ($) ............................................................................................................................................
3,854,152
109.56
Subtotal, all renewal applications ($) ...........................................................................................................................................
6,830,565
Total cost savings to registrants ($) ......................................................................................................................................
10,684,716
khammond on DSKJM1Z7X2PROD with PROPOSALS
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.
VerDate Sep<11>2014
20:39 Feb 01, 2023
Jkt 259001
(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.
PO 00000
Frm 00026
Fmt 4702
Sfmt 4702
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:
E:\FR\FM\02FEP1.SGM
DEA.
02FEP1
7038
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules
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 × 0.7) in year 2 and thereafter.
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.
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.
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 waittimes for callers rather than reduced call
center resources. Therefore, DEA
estimates this cost will remain the same
at $1,749,946.
6. Information Technology (IT) Cost:
DEA currently spends approximately
$255,000 per year on its IT enrollmentrelated systems and software. DEA
anticipates IT costs will increase to
$2,935,200 per year.27 IT cost includes,
but are not limited to, cloud services,
workflow management, identity
verification, identity management
functionality, professional services for
continuous development, integration
and deployment, and maintenance and
troubleshooting.
All costs are expected to scale with
the volume of new applications, except
IT cost, which does not vary with the
volume of applications. Table 5
summarizes the DEA’s impact.
TABLE 5—TOTAL DEA IMPACT
[Initial and remaining years]
Current
($)
Year 1
($)
Year 1,
change from
current
($)
Year 2 *
($)
Year 2,
change from
current
($)
Number of applications ........................................................
Certificate Authority ..............................................................
Registration Authority ** .......................................................
Mail preparation (received mail) ..........................................
Data Entry ............................................................................
Call Center Support .............................................................
Information Technology .......................................................
31,172
732,992
597,688
34,562
109,138
1,749,946
255,000
31,172
732,992
418,382
........................
........................
1,749,946
2,935,200
........................
........................
¥179,306
¥34,562
¥109,138
........................
2,680,200
31,172
418,382
418,382
........................
........................
1,749,946
2,935,200
........................
¥314,610
¥179,306
¥34,562
¥109,138
........................
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 10year analysis period is listed in Table 8.
khammond on DSKJM1Z7X2PROD with PROPOSALS
TABLE 6—DEA AND REGISTRANT TOTAL IMPACT
Year
1 ...................................................................................................................................................
2 ...................................................................................................................................................
23 Source:
24 Source:
DEA.
DEA.
VerDate Sep<11>2014
17:12 Feb 01, 2023
25 Source:
26 Source:
Jkt 259001
Net cost
savings to
DEA
(net cost)
($)
Total cost
savings to
registrants
($)
PO 00000
DEA.
DEA.
Frm 00027
Fmt 4702
10,684,716
10,684,716
27 Source:
Sfmt 4702
E:\FR\FM\02FEP1.SGM
DEA.
02FEP1
(2,536,501)
(2,357,194)
Total net
cost savings,
registrant +
DEA
($)
8,148,216
8,327,522
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules
7039
TABLE 6—DEA AND REGISTRANT TOTAL IMPACT—Continued
Total cost
savings to
registrants
($)
Year
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
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
10,684,716
10,684,716
10,684,716
10,684,716
10,684,716
10,684,716
10,684,716
10,684,716
Net cost
savings to
DEA
(net cost)
($)
(2,357,194)
(2,357,194)
(2,357,194)
(2,357,194)
(2,357,194)
(2,357,194)
(2,357,194)
(2,357,194)
Total net
cost savings,
registrant +
DEA
($)
8,327,522
8,327,522
8,327,522
8,327,522
8,327,522
8,327,522
8,327,522
8,327,522
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.
TABLE 7—PERCENTAGE AND NUMBER OF REGISTERED LOCATIONS BY BUSINESS ACTIVITY
Number of
entities
khammond on DSKJM1Z7X2PROD with PROPOSALS
Business activity
Percent
Renewal cycle
(years)
Pharmacy .....................................................................................................................................
Hospital/Clinic ..............................................................................................................................
Practitioner/Mid-Level Practitioner (MLP) ....................................................................................
Teaching Institution ......................................................................................................................
Manufacturer ................................................................................................................................
Distributor/Importer/Exporter ........................................................................................................
Researcher ..................................................................................................................................
Analytical Lab ..............................................................................................................................
Reverse Distributor ......................................................................................................................
Narcotic Treatment Program (NTP) ............................................................................................
62,291
11,898
18,095
14
103
444
247
26
5
888
66.26
12.66
19.25
0.01
0.11
0.47
0.26
0.03
0.01
0.94
3
3
3
3
1
1
1
1
1
1
Total .............................................................................................................................................
94,011
100.00
* 2.97
* Weighted average.
(Source: DEA).
28 21
CFR 1311.40(c).
VerDate Sep<11>2014
17:12 Feb 01, 2023
Jkt 259001
PO 00000
Frm 00028
Fmt 4702
Sfmt 4702
E:\FR\FM\02FEP1.SGM
02FEP1
7040
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules
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
Pharmacy ...................................................
445110
446110
452210
452311
621111
621112
621330
621420
621491
621493
622110
622210
622310
611310
325411
325412
424210
541715
NTP, Hospital/Clinic, Practitioner, MLP* ....
Teaching Institute .......................................
Manufacturer ..............................................
Distributor, Importer, Exporter ....................
Researcher .................................................
Analytical Labs ...........................................
Reverse Distributor ....................................
541380
562213
562219
NAICS code description
Supermarkets and Other Grocery (except Convenience) Stores.
Pharmacies and Drug Stores.
Department Stores.
Warehouse Clubs and Supercenters.
Offices of Physicians (except Mental Health Specialists).
Offices of Physicians, Mental Health Specialists.
Offices of Mental Health Practitioners (except Physicians).
Outpatient Mental Health and Substance Abuse Centers.
HMO Medical Centers.
Freestanding Ambulatory Surgical and Emergency Centers.
General Medical and Surgical Hospitals.
Psychiatric and Substance Abuse Hospitals.
Specialty (except Psychiatric and Substance Abuse) Hospitals.
Colleges, Universities and Professional Schools.
Medicinal and Botanical Manufacturing.
Pharmaceutical Preparation Manufacturing.
Drugs and Druggists’ Sundries Merchant Wholesalers.
Research and Development in the Physical, Engineering, and Life Sciences (except
Nanotechnology and Biotechnology).
Testing Laboratories.
Solid Waste Combustors and Incinerators.
Other Nonhazardous Waste Treatment and Disposal.
khammond on DSKJM1Z7X2PROD with PROPOSALS
* 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
VerDate Sep<11>2014
17:12 Feb 01, 2023
Jkt 259001
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
PO 00000
Frm 00029
Fmt 4702
Sfmt 4702
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.
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 $125.69 (109.56 + 11.13 +
5.00 = 125.69), as can be seen in Table
9.
29 Note
30 Note
E:\FR\FM\02FEP1.SGM
18.
20.
02FEP1
7041
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules
TABLE 9—COST SAVINGS PER NEW APPLICATION
Current
($)
New
($)
Cost savings
($)
Labor cost per New app ..............................................................................................................
Postage cost per app ..................................................................................................................
Cost of notary ..............................................................................................................................
262.95
11.13
5.00
153.39
........................
........................
109.56
11.13
5.00
Total ......................................................................................................................................
........................
........................
125.69
As also calculated in the E.O. 12866
section above, total cost savings for
renewals is $109.56, as can be seen in
Table 10.
TABLE 10—COST SAVINGS PER RENEWAL APPLICATION
Current
($)
New
($)
Cost savings
($)
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
TABLE 11—AVERAGE ANNUAL REVENUE OF SMALLEST OF SMALL ENTITIES
khammond on DSKJM1Z7X2PROD with PROPOSALS
NAICS
Enterprise size
(number of
employees)
NAICS description
325411
325412
424210
445110
446110
452210
452311
541380
541715
..
..
..
..
..
..
..
..
..
562213
562219
611310
621111
621112
621330
621420
621491
621493
622110
622210
622310
..
..
..
..
..
..
..
..
..
..
..
..
Medicinal and Botanical Manufacturing .................................................
Pharmaceutical Preparation Manufacturing ...........................................
Drugs and Druggists’ Sundries Merchant Wholesalers .........................
Supermarkets and Other Grocery (except Convenience) Stores ..........
Pharmacies and Drug Stores .................................................................
Department Stores .................................................................................
Warehouse Clubs and Supercenters .....................................................
Testing Laboratories ...............................................................................
Research and Development in the Physical, Engineering, and Life
Sciences (except Nanotechnology and Biotechnology).
Solid Waste Combustors and Incinerators .............................................
Other Nonhazardous Waste Treatment and Disposal ...........................
Colleges, Universities, and Professional Schools ..................................
Offices of Physicians (except Mental Health Specialists) ......................
Offices of Physicians, Mental Health Specialists ...................................
Offices of Mental Health Practitioners (except Physicians) ...................
Outpatient Mental Health and Substance Abuse Centers .....................
HMO Medical Centers ............................................................................
Freestanding Ambulatory Surgical and Emergency Centers .................
General Medical and Surgical Hospitals ................................................
Psychiatric and Substance Abuse Hospitals ..........................................
Specialty (except Psychiatric and Substance Abuse) Hospitals ............
31 Census Bureau, Statistics of U.S. Businesses
Revenue Data by Size, 2017. https://
www.census.gov/programs-surveys/susb.html.
(Released 5/28/2021).
VerDate Sep<11>2014
17:12 Feb 01, 2023
Jkt 259001
Number of
establish-ments
0–4
0–4
0–4
0–4
0–4
0–4
0–4
0–4
0–4
239
390
4,076
20,741
7,052
3
20
2,427
4,895
690
1,173
1,512
519
1,328
467
475
316
449
0–4
0–4
0–4
0–4
0–4
0–4
0–4
0–4
0–4
0–4
0–4
0–4
15
183
458
91,892
9,031
22,653
3,019
27
1,188
79
10
8
949
580
802
465
291
165
248
98
666
15,559
1,024
1,965
32 Census Bureau, Statistics of U.S. Businesses
Number of Establishment Data by Size, 2019.
https://www.census.gov/programs-surveys/
susb.html. (Released 2/11/2022).
PO 00000
Frm 00030
Fmt 4702
Sfmt 4702
Average revenue
per establishment
($ thousands)
E:\FR\FM\02FEP1.SGM
02FEP1
7042
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules
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
$125.69 (109.56 + 11.13 + 5 = 125.69),
or 0.13 percent of revenues (125.69/
98,000 = 0.0013). The benefit from
renewals is 0.11 percent of revenues
(109.56/98,000 = 0.0011). Table 12
details the revenue test results for all
affected NAICS codes.
TABLE 12—REVENUE TEST OF SMALLEST OF SMALL ENTITIES
NAICS description
325411 ..
325412 ..
424210 ..
Medicinal and Botanical Manufacturing .....
Pharmaceutical Preparation Manufacturing
Drugs and Druggists’ Sundries Merchant
Wholesalers.
Supermarkets and Other Grocery (except
Convenience) Stores.
Pharmacies and Drug Stores .....................
Department Stores .....................................
Warehouse Clubs and Supercenters .........
Testing Laboratories ...................................
Research and Development in the Physical, Engineering, and Life Sciences (except
Nanotechnology
and
Biotechnology).
Solid Waste Combustors and Incinerators
Other Nonhazardous Waste Treatment
and Disposal.
Colleges, Universities, and Professional
Schools.
Offices of Physicians (except Mental
Health Specialists).
Offices of Physicians, Mental Health Specialists.
Offices of Mental Health Practitioners (except Physicians).
Outpatient Mental Health and Substance
Abuse Centers.
HMO Medical Centers ................................
Freestanding Ambulatory Surgical and
Emergency Centers.
General Medical and Surgical Hospitals ....
Psychiatric and Substance Abuse Hospitals.
Specialty (except Psychiatric and Substance Abuse) Hospitals.
445110 ..
446110
452210
452311
541380
541715
..
..
..
..
..
562213 ..
562219 ..
611310 ..
621111 ..
621112 ..
621330 ..
621420 ..
621491 ..
621493 ..
622110 ..
622210 ..
622310 ..
khammond on DSKJM1Z7X2PROD with PROPOSALS
Average revenue
per establishment
($ thousands)
NAICS
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.
17:12 Feb 01, 2023
Jkt 259001
Percent of
revenue
(%)
0.02
0.01
0.01
109.56
109.56
109.56
0.02
0.01
0.01
519
125.69
0.02
109.56
0.02
1,328
467
475
316
449
125.69
125.69
125.69
125.69
125.69
0.01
0.03
0.03
0.04
0.03
109.56
109.56
109.56
109.56
109.56
0.01
0.02
0.02
0.03
0.02
949
580
125.69
125.69
0.01
0.02
109.56
109.56
0.01
0.02
802
125.69
0.02
109.56
0.01
465
125.69
0.03
109.56
0.02
291
125.69
0.04
109.56
0.04
165
125.69
0.08
109.56
0.07
248
125.69
0.05
109.56
0.04
98
666
125.69
125.69
0.13
0.02
109.56
109.56
0.11
0.02
15,559
1,024
125.69
125.69
0.00
0.01
109.56
109.56
0.00
0.01
1,965
125.69
0.01
109.56
0.01
This proposed rule would modify
existing collection(s) of information
requirement under the Paperwork
U.S.C. 1501 et seq.
Fmt 4702
Sfmt 4702
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
A. Collections of Information Associated
With the Proposed Rule
1. Title: CSOS Certificate Application.
OMB Control Number: 1117–0038.
Paperwork Reduction Act
Frm 00031
Benefit from
renewal
applications
($)
125.69
125.69
125.69
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 $100,000,000 or more
(adjusted annually for inflation) in any
1 year.’’ Therefore, neither a Small
Government Agency Plan nor any other
action is required under the UMRA.
PO 00000
Percent of
revenue
(%)
690
1,173
1,512
Unfunded Mandates Reform Act of 1995
33 2
VerDate Sep<11>2014
Benefit from
new
applications
($)
34 44
U.S.C. 3501–3521.
U.S.C. 3507(d).
36 Copies of existing information collections
approved by OMB may be obtained at https://
www.reginfo.gov/public/do/PRAMain.
35 44
E:\FR\FM\02FEP1.SGM
02FEP1
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules
khammond on DSKJM1Z7X2PROD with PROPOSALS
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:
• Number of respondents: 94,011.
• Frequency of response: 0.994735 (as
needed, calculated).37
• Number of responses: 93,516.
• Burden per response: 0.75.38
• 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:
• 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.
• The accuracy of DEA’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used.
• Recommendations to enhance the
quality, utility, and clarity of the
information to be collected.
• 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
37 Calculated by dividing the number of responses
(93,516) by the number of respondents (94,011).
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 × 1.75] + [0.67 * 0.25]
= 0.75).
39 44 U.S.C. 3506(c)(2).
VerDate Sep<11>2014
17:12 Feb 01, 2023
Jkt 259001
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
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.
2. Amend § 1311.20 by revising
paragraphs (b) and (c) to read as follows:
■
§ 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
§ 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.
■ 3. Revise § 1311.25 to read as follows:
PO 00000
Frm 00032
Fmt 4702
Sfmt 4702
7043
§ 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 www.deaecom.gov 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.
■ 4. Amend § 1311.40 by revising
paragraphs (c) and (d) to read as follows:
§ 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 www.deaecom.gov
twice. For every third renewal, the
CSOS certificate holder must submit a
new application and documentation, as
provided in § 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
§ 1311.25.
E:\FR\FM\02FEP1.SGM
02FEP1
7044
§ 1311.60
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules
[Amended]
5. Amend § 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
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 402, 880, 881, 883, 884,
886, 891
[Docket No. FR–6320–A–01]
RIN 2502–AJ62
Federal Housing Administration (FHA):
Section 8 Project-Based Rental
Assistance: Standard Program
Regulation and Renewal Contract;
Advance Notice of Proposed
Rulemaking and Request for Public
Comment
Office of the Assistant
Secretary for Housing—Federal Housing
Commissioner, Office of Multifamily
Housing Programs, HUD.
ACTION: Advance notice of proposed
rulemaking and request for public
comment.
AGENCY:
The Office of Multifamily
Housing Programs (MFH) seeks
comments from the public regarding an
initiative under which MFH, in
partnership with owners, tenants, and
other program stakeholders, would
move toward a single Section 8 program
regulation and single contract form
pursuant to which the Secretary would
renew project-based Section 8 Housing
Assistance Payments (HAP) contracts
under section 524 of the Multifamily
Assisted Housing Reform and
Affordability Act of 1997 (MAHRA).
khammond on DSKJM1Z7X2PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
17:12 Feb 01, 2023
Jkt 259001
Section 524 authorizes the Secretary to
establish the terms and conditions
under which expiring contracts are
renewed, subject to the requirements of
section 524. Currently, the Secretary
issues one of several section 524
renewal contracts, which is subject to
one of seven Section 8 regulatory parts
under which the original contract was
issued, as well as other HUD regulations
implementing section 524. To reduce
regulatory complexities, MFH envisions
promulgating a single Section 8 projectbased rental assistance program
regulation consisting of a standardized
set of Section 8 program requirements
and a single form of section 524 renewal
contract.
DATES: Comment Due Date: Written
comments must be received on or before
April 3, 2023.
ADDRESSES: Interested persons are
invited to submit comments regarding
this advance notice of proposed
rulemaking. There are two methods for
submitting public comments. All
submissions must refer to the above
docket number and title.
1. Submission of Comments by Mail.
Members of the public may submit
comments by mail to the Regulations
Division, Office of General Counsel,
Department of Housing and Urban
Development, 451 7th Street SW, Room
10276, Washington, DC 20410–0500.
Due to security measures at all federal
agencies, however, submission of
comments by standard mail often results
in delayed delivery. To ensure timely
receipt of comments, HUD recommends
that comments submitted by standard
mail be submitted at least two weeks in
advance of the deadline. HUD will make
all comments received by mail available
to the public at https://
www.regulations.gov.
2. Electronic Submission of
Comments. Interested persons may
submit comments electronically through
the Federal eRulemaking Portal at
www.regulations.gov. HUD strongly
encourages commenters to submit
comments electronically. Electronic
submission of comments allows the
commenter maximum time to prepare
and submit a comment, ensures timely
receipt by HUD, and enables HUD to
make comments immediately available
to the public. Comments submitted
electronically through the
www.regulations.gov website can be
viewed by other commenters and
interested members of the public.
Commenters should follow the
instructions provided on that site to
submit comments electronically.
Note: To receive consideration as
public comments, comments must be
PO 00000
Frm 00033
Fmt 4702
Sfmt 4702
submitted through one of the two
methods specified above. All
submissions must refer to the docket
number and title of the rule.
No Facsimile Comments. Facsimile
(FAX) comments are not acceptable.
3. Public Inspection of Public
Comments. All properly submitted
comments and communications
submitted to HUD are available for
public inspection and copying between
8 a.m. and 5 p.m. weekdays at the above
address. Due to security measures at the
HUD Headquarters building, an advance
appointment to review the public
comments must be scheduled by calling
the Regulations Division at 202–708–
3055 (this is not a toll-free number).
Individuals with speech or hearing
impairments may access this number
via teletypewriter (TTY) by calling the
Federal Relay Service at 800–877–8339
(this is a toll-free number). Copies of all
comments submitted are available for
inspection and downloading at
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jennifer Lavorel, Director, Program
Administration Division, Office of Asset
Management Portfolio Oversight, U.S.
Department of Housing and Urban
Development, 451 7th Street, SW,
Washington, DC 20410, telephone
number 202–402–2515 (this is not a tollfree number). Individuals with speech
or hearing impairments may access this
number via TTY by calling the Federal
Relay Service at 800–877–8339 (this is
a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
The Housing and Community
Development Act of 1974, Public Law
93–383 (Aug. 22, 1974) amended the
United States Housing Act of 1937 to
add Section 8. Congress established a
new project-based rental assistance
(PBRA) program under which public
housing agencies under contract with
HUD were authorized to enter into
Housing Assistance Payments (HAP)
contracts on behalf of eligible lowincome families occupying new,
substantially rehabilitated, or existing
rental units. In 1983, Congress repealed
PBRA authority for new construction
and substantial rehabilitation HAP
contracts. As original HAP contracts
began to expire, Congress enacted the
Multifamily Assisted Housing Reform
and Affordability Act of 1997, Public
Law 105–65 (Oct. 27, 1997), which
authorized the renewal of expiring HAP
contracts. Section 524 of MAHRA
authorizes the renewal of HAP contracts
at market rents (524(a)(4)(c)) and abovemarket rents (524(a)(4)(B)), for contracts
E:\FR\FM\02FEP1.SGM
02FEP1
Agencies
[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 [www.gpo.gov]
[FR Doc No: 2023-01804]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
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 https://www.regulations.gov
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
Regulations.gov. If you have received a Comment Tracking Number, your
comment has been successfully submitted and there is no need to
resubmit the same comment.
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 https://www.regulations.gov. 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 https://www.regulations.gov 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 https://www.regulations.gov 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\
---------------------------------------------------------------------------
\1\ 21 U.S.C. 958(f).
\2\ 28 CFR 0.100(b).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 deadiversion.gov website to
the CSOS log-in page. From the CSOS log-in page the applicant will be
redirected to Login.gov for Identification Verification. Upon arrival
at the site, the applicant will be asked to create a Login.gov account
by entering a valid email address, selecting a default language, and
agreeing to Login.gov'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 Login.gov 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 Login.gov
website, the applicant must agree to the site's security statement.
Login.gov next requires applicants to upload photographs of one or more
forms of identification as specified by Login.gov 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 Login.gov
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.
---------------------------------------------------------------------------
\11\ 21 CFR part 1311 et seq.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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), https://www.reginfo.gov/public/do/eAgendaMain?operation=OPERATION_GET_AGENCY_RULE_LIST¤tPub=true&agencyCode=&showStage=active&agencyCd=1100&csrf_token=F19C7C599C70B80C228EC16B60AEB150F6339AF3C80E56FE003EEB7D3A758895BC8E16A215E8A0466326EBFBA8639F799E09 (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).
---------------------------------------------------------------------------
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
------------------------------------------------------------------------
21 CFR Location Current Proposed
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\13\ 21 CFR 1311.40(c).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\14\ Source: DEA.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\15\ U.S. Bureau of Labor Statistics (BLS), Occupational
Employment and Wages, May 2021, 29-1051 Pharmacists. https://www.bls.gov/oes/current/oes291051.htm. (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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\18\ FedEx Ground rates for a one-pound package using zone five,
effective January 4, 2021 and downloaded on 4/6/2022.
---------------------------------------------------------------------------
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.
19 20 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.
---------------------------------------------------------------------------
\19\ National Notary Association, ``2022 Notary Fees by State''.
https://www.nationalnotary.org/knowledge-center/about-notaries/notary-fees-by-state (accessed 4/6/2022).
\20\ Notary fees can range from $1 to $25. DEA has decided to
use $5 as its estimate of notary fees. DEA believes many applicants
can get documents notarized at low costs, i.e., at banks, employees
with public notary, etc.
---------------------------------------------------------------------------
4. Agreement Storage Costs: Under current regulations, a CSOS
certificate holder is required to maintain a copy of
[[Page 7037]]
the subscriber agreement. The proposed rule would eliminate this
requirement. DEA does not believe there is a material impact from not
having to store written subscription agreements and having them be
stored online in CSOS.
Table 2 summarizes the impact of the proposed rule for new
applications.
Table 2--Registrant Impact: New Application
----------------------------------------------------------------------------------------------------------------
Cost savings
Current ($) New ($) ($)
----------------------------------------------------------------------------------------------------------------
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
-----------------------------------------------
Total new application....................................... .............. .............. 123.64
----------------------------------------------------------------------------------------------------------------
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. https://www.census.gov/programs-surveys/susb.html.
(Released 5/28/2021).
\32\ Census Bureau, Statistics of U.S. Businesses Number of
Establishment Data by Size, 2019. https://www.census.gov/programs-surveys/susb.html. (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 https://www.reginfo.gov/public/do/PRAMain.
---------------------------------------------------------------------------
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:
Number of respondents: 94,011.
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).
---------------------------------------------------------------------------
Number of responses: 93,516.
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).
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
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.
The accuracy of DEA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used.
Recommendations to enhance the quality, utility, and
clarity of the information to be collected.
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 www.deaecom.gov 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
www.deaecom.gov 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