[Federal Register Volume 88, Number 119 (Thursday, June 22, 2023)]
[Rules and Regulations]
[Pages 40707-40713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13085]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA-574]
RIN 1117-AB57
Reporting Theft or Significant Loss of Controlled Substances
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration (DEA) is publishing this
final rule amending the regulations regarding DEA Form 106, used by DEA
registrants to formally report thefts or significant losses of
controlled
[[Page 40708]]
substances, to require that all such forms be submitted electronically,
and to clarify the time frame registrants have to complete the
necessary documentation. This final rule does not change the
requirement that registrants preliminarily notify the DEA Field
Division Office in their area, in writing, of the theft or significant
loss of any controlled substances within one business day of
discovering such loss or theft. Paper copies of DEA Form 106 simply
will no longer be accepted once the final rule becomes effective.
DATES: The final rule is effective July 24, 2023.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 776-3882.
SUPPLEMENTARY INFORMATION:
Background and Legal Authority
The Controlled Substances Act (CSA) authorizes the Administrator of
the Drug Enforcement Administration (DEA) (by delegation from the
Attorney General) to promulgate rules and regulations relating to the
registration and control of the manufacture, distribution, and
dispensing of controlled substances; maintenance and submission of
records and reports related there to; and for the efficient execution
of her statutory functions concerning controlled substances.\1\ DEA
regulations require DEA registrants--both practitioners and non-
practitioners--to notify their local Field Division Office, in writing,
of any theft or significant loss of any controlled substances within
one business day of discovery of the theft or loss, and they complete
and submit to the same Field Division a DEA Form 106 regarding the
theft or loss.\2\ However, the regulations are silent as to the actual
submission method for DEA Form 106 (e.g., mail, hand delivery,
electronic) and the deadline for submitting DEA Form 106.
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\1\ 21 U.S.C. 821, 827, and 871(b).
\2\ 21 CFR 1301.74(c) and 1301.76(b) for non-practitioner and
practitioner registrants, respectively. The provision at 21 CFR
1301.74(c) sets forth certain exceptions regarding in-transit losses
and import/export transactions.
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In contrast, DEA regulations set forth a mandatory electronic
submission method and reporting deadline for DEA Form 107, a form used
by regulated persons \3\ to report any unusual or excessive loss or
disappearance of a listed chemical. Under 21 CFR 1310.05(b)(1), in
addition to certain other specified reporting requirements, a regulated
person must file a complete and accurate DEA Form 107, in accordance
with 21 CFR 1310.06(d), with DEA through DEA's Diversion Control
Division secure network application within 15 calendar days after
becoming aware of the circumstances requiring the report.
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\3\ The term ``regulated person'' is defined at 21 U.S.C.
802(38).
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Based on submission data from 2018, 99.5 percent of all DEA Form
106 submissions are completed electronically via DEA's secure website.
The remaining 0.5 percent of form submissions are completed by paper.
Proposed Rule
DEA published a notice of proposed rulemaking (NPRM) on July 29,
2020,\4\ proposing to require that DEA registrants electronically file
a complete and accurate DEA Form 106 within 15 calendar days after
discovery of the theft or significant loss of any controlled
substances. The intent of this rule was to clarify the submission
process, requiring that all forms be submitted electronically through
DEA's secure online database similar to the submission process and
reporting time period for DEA Form 107. Finally, per the NPRM, there's
no change to specific requirements for 21 CFR 1301.74(c) and 1301.76(b)
that non-practitioners and practitioners preliminarily notify their
local DEA Field Division Office, in writing, of the theft or
significant loss of any controlled substances within one business day
of discovering such theft or loss.
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\4\ 85 FR 45547.
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Discussion of Comments
DEA received 22 comments in response to the NPRM. These comments
were from associations, manufacturer registrants, healthcare systems,
individuals, anonymous commenters, and others. Of these comments, two
commenters were in support for the rule while having concerns for
certain aspects of the proposed amendments and one commenter did not
express a position on the rule. One comment was political in nature and
does not relate to the proposed rule. The other commenters expressed
concerns about the 15-day reporting time frame and other issues, and
provided suggestions. This rule will not respond to the comment outside
of the scope of the proposed rule. The other comments are described and
considered below.
Support of the 15-Day Timeframe
Issue: There are two comments (SpecGX LLC, individual) in favor of
the 15-day timeframe, provided DEA clarify certain aspects. SpecGX LLC
supports the 15-day timeframe as long as they are able to update the
information on the already submitted DEA Form 106 if they have
recovered more of the lost or stolen items that were previously
reported ``lost.'' This commenter believed that it is better to have a
complete, accurate record in order to accurately assess and report. The
individual commenter felt that the timeline for the submission is
reasonable, but suggested that the timeline be expanded during the
initial period for those who have not reported electronically.
DEA Response: DEA appreciates the support of the proposed 15-day
timeframe and the electronic submission of DEA Form 106. It is unclear
to DEA what the individual commenter means by the ``initial'' period.
However, when proposing the 15-day timeframe, DEA wanted to mirror the
submission process and reporting time frame for DEA Form 107.\5\ As
explained in the NPRM preamble, and in the above background section,
DEA regulations require that DEA Form 107 be submitted through the DEA
Diversion Control Division secure network application within 15
calendar days after becoming aware of the circumstances requiring the
report.\6\ As noted above, DEA regulations, 21 CFR 1301.74(c) and
1301.76(b), also require that registrants preliminarily notify their
local DEA Field Division Office, in writing, of the theft or
significant loss of any controlled substances within one business day
of discovery of theft or loss. For those that have never submitted the
report online, this will give them more time to complete their
investigations and get acquainted with the online submission system.
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\5\ 85 FR 45547, 45549.
\6\ 21 CFR 1310.05(b)(1).
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Objection to the 15-Day Timeframe
Issue: A majority of the commenters did not favor the 15-day
timeframe, and instead suggested that DEA implement a 30-day, 45-day,
or 60-day timeframe. The National Community Pharmacists Association
(NCPA) stated that DEA should adopt the 15-day timeframe instead of the
60-day timeframe, but asked that DEA delay the implementation of the
time limit until the current public health emergency of coronavirus
disease (COVID-19) ends. The American Pharmacists Association (APhA)
stated that the 15-day timeframe was insufficient because it was not
enough time to complete all required documentation and investigations,
and would be unduly burdensome to the registrants.
[[Page 40709]]
DEA Response: DEA appreciates the concerns noted in the comments.
DEA understands that adequate time is needed in order to complete an
accurate and thorough investigation. DEA will allow registrants 45 days
to submit DEA Form 106, which DEA believes is more than enough time to
conduct investigations. DEA disagrees with postponing the effective
date of this rule.
One-Day Reporting Requirement
Issue: A few commenters (NACDS; two individuals) expressed concerns
about DEA's current requirements to preliminarily report, in writing,
to the local DEA Field Division office any theft or significant loss of
any controlled substances within one business day of discovering such
theft or loss, and also to separately file DEA Form 106 with the local
DEA Field Division office within a non-specified time frame (noting
that the proposal would change the submission of DEA Form 106 to an
electronic submission only and stipulate a 15-day reporting time
frame). These commenters contended that the one-day reporting
requirement is arbitrary, confusing, and redundant to that of the DEA
Form 106 reporting requirement. In order to streamline reporting and
reduce administrative burden, two of the commenters requested that DEA
abolish the one-day reporting requirement altogether. Alternatively,
these two commenters suggested that DEA make the reporting time frame
for the one-day report match that of DEA Form 106, and the registrant
could utilize one online reporting tool to satisfy both requirements.
The third commenter requested that DEA only have one reporting
requirement, in which a registrant would ``immediately file'' a report
electronically at a ``central location'' with DEA; the central location
could then electronically notify the registrant's regional office; and
the regional office could follow up with the registrant for more
details as appropriate.
DEA Response: DEA believes it is appropriate to retain the two-step
reporting requirement, consisting of the preliminary one-day reporting
and the DEA Form 106 reporting. The one-day reporting notification
allows DEA to know right away about the theft and significant loss, to
have an immediate record of the initial incident, and allows DEA to
promptly institute any actions deemed appropriate to the situation,
including working with the registrant to address the theft or loss.
With the one-day reporting documentation, DEA is able to have a record
of any registrant that reports the theft and loss. As well, the
registrant will have a record of the date of the documentation and to
whom it was sent. Also, the commenter's suggestion for follow-up by the
regional office would shift the burden to DEA, and may well lead to
non-uniform reporting of these incidents. Therefore, DEA will not make
any changes to that requirement in this final rule. The second report--
the submission of DEA Form 106--is important because it allows the
registrant time to adequately investigate the theft or loss and make a
final determination. As discussed above, this final rule implements a
45-day time frame (instead of the proposed 15-day time frame) for
registrants to electronically submit DEA Form 106. As the time frames
for the preliminary reporting and DEA Form 106 are different, it is not
possible for the registrant to utilize an online reporting tool to
satisfy both reporting requirements at one time.
Responsibility for Filing
Issue: One commenter stated that a clinic owned by multiple doctors
who each have individual DEA registrations, may not necessarily know
whose controlled substances were lost. The commenter said that it is
not clear from the regulation how that issue would be resolved and
asked whether one or all of the practitioners should file DEA Form 106.
DEA Response: DEA regulations require each registrant to provide
effective controls and procedures to guard against theft and diversion
of controlled substances \7\ and to maintain complete and accurate
records of controlled substances.\8\ Individual registrants in a
multiple registrant clinic setting should be responsible for their own
records and controlled substance storage. Records and controlled
substances for each individual DEA registrant should be kept separate
from all other registrants to aide in distinguishing which controlled
substances belong to which DEA registrant. Therefore, each registered
practitioner whose stock was affected by the theft or loss, is
responsible for providing the one-day notification to DEA's Field
Division Office and for filing DEA Form 106. Each practitioner is
responsible for designating who files a report of theft or loss within
their clinic or pharmacy, therefore, DEA leaves this decision solely
for the practitioner.
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\7\ 21 CFR 1301.71(a).
\8\ 21 CFR 1304.21(a).
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Definition of Terms
Issue: One commenter requested that DEA distinguish ``significant''
loss from ``normal'' loss.
DEA Response: DEA regulations require registrants to provide
effective controls and procedures to guard against theft and diversion
of controlled substances,\9\ but the regulations do not provide a
specific definition of ``significant loss''. What constitutes a
significant loss for one registrant may be construed as comparatively
insignificant for another. A manufacturer may experience continuous
losses in the manufacturing process due to, for example, atmospheric
changes or mixing procedures. Such losses may not be deemed by the
registrant to be significant and may be recorded in batch records.
Conversely, for registrants other than manufacturers, the repeated loss
of even small quantities of controlled substances over a period of time
may indicate a significant aggregate significant loss that must be
reported to DEA, even though the individual quantity of each occurrence
is not significant. The distinction between a significant loss and a
normal loss is case and circumstance specific, and registrants are best
positioned to determine whether a loss rises to the level of a
significant loss. Therefore, DEA declines to add a definition for
``significant loss'' in this final rule.
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\9\ 21 CFR 1301.71(a).
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Issue: One commenter requested that DEA define the term
``discover.''
DEA Response: DEA previously acknowledged that there is some
confusion on the meaning of ``discovery'' and recognized that the
discovery occurs in incremental stages.\10\ At that time, DEA did not
define ``discovery'' in the regulatory text. DEA is planning on
addressing the definition of Discovery in a future rulemaking. For the
purposes of this final rule, DEA is only addressing the parameters
surrounding the DEA Form 106 submission timeframe and the 1-day
reporting requirement.
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\10\ 70 FR 47094, 47095, August 12, 2005.
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Other Comments
Issue: One commenter, CVS Health, asked whether the electronic DEA
Form 106 should include more categories, specifically ``Unknown'' and
``Other,'' as they believe this would enable them to more accurately
report if the existing categories did not apply to the particular
situation. This commenter noted that the ``Unknown'' category
previously existed, and asked that it be reinstated. The Healthcare
Distribution Alliance (HDA) mentioned that they
[[Page 40710]]
would like the ``Other'' category to be reinstated as that will allow
for accurate reporting of the potential theft or loss incidents that do
not fit the current response options. HDA also encouraged DEA to create
a guidance document that not only would guide registrants on how to
complete DEA Form 106, but also establish a compliance procedure in the
event that the electronic submission is not operable (e.g., several-day
power outage, a natural disaster that's out of the registrant's
control, etc.).
DEA Response: DEA will continue to use the categories that are
currently listed on DEA Form 106. DEA wants accurate information, and
the categories ``unknown'' and ``other'' would provide vague
information and confusion to DEA officials. In addition, DEA has
provided guidelines for completing DEA Form 106, which can be found at
https://www.deadiversion.usdoj.gov/pubs/manuals/(DEA-DC-046)(EO-
DEA154)_Pharmacist_Manual.pdf in Appendix I of the Pharmacist's Manual.
Finally, regarding the request to establish a compliance procedure in
the event that the electronic submission is not operable (e.g.,
several-day power outage, a natural disaster that's out of the
registrant's control, etc.), it is the responsibility of the registrant
to maintain effective controls against diversion and design and operate
compliance procedures to that end. However, in the event of any
technical issues involving the DEA system being down, the registrant
can report the issues by calling the DEA Help Center at 1-800-882-9539.
If there is a need to submit DEA Form 106 while the DEA system is down,
the registrant can document the day and time of their attempted
submission(s) and their successful submission, and retain these
records.
Issue: One commenter asked if DEA has an alternative for rural
residents who are unable to make their submissions electronically, as
well as if there are any alternate submission plans should the network
be down.
DEA Response: Should a DEA registrant that lives in a rural
residency feel the need to request an exception from the electronic
submission requirement, they can write DEA to request an exception to
regulations pursuant to 21 CFR 1307.03. In the event of any technical
issues involving the network being down or otherwise unable to submit
DEA Form 106 online, the registrant can report the issues by calling
the DEA Help Center at 1-800-882-9539.
Issue: The National Association of Chain Drug Stores (NACDS) and
the HDA stated that when a registrant fills out DEA Form 106, enters a
National Drug Code (NDC), and submits the form via the secure online
system, if the NDC isn't up to date, then the submission is rejected by
the secure network application. When new or changed drug codes are not
present, this creates challenges when reporting and results in
inaccurate reports. In these cases, when a form is rejected
electronically, the only other option is to report it via paper. NACDS
also mentioned that there are some field office conflicts. Some offices
prefer faxes while others want written letters sent to particular email
addresses. NACDS is suggesting that there be consistency with the DEA
field offices.
DEA Response: The NDC is updated on a monthly basis and as needed
when a registrant reports an NDC as not listed. Should the registrant
have any questions, they can send an email at [email protected], or the
registrant can indicate which NDC is missing or not included in the NDC
library on the one day reporting notification. Currently, registrants
are required to notify their local DEA Field Office, preliminarily in
writing, of any theft or significant loss.\11\ While faxing is one
method of notifying, it isn't the only option. DEA leaves the decision
of which method of writing is preferred to the discretion of the local
DEA Field Offices.
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\11\ 21 CFR 1301.74(c).
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Section-by-Section Description of Rule Changes
This final rule sets forth in 21 CFR 1301.74(c) and 1301.76(b) that
DEA registrants will have a 45-day calendar period (instead of the
proposed 15-day calendar period), upon discovery of the theft or
significant loss of any controlled substances, to submit DEA Form 106.
This rule finalizes the other proposed provisions that DEA Form 106 be
complete and accurate, and the submission be done electronically
through DEA's Diversion Control Division secure network application
(available on DEA's Diversion Control Division website).
Regulatory Analyses
Executive Orders 12866 and 13563, Regulatory Planning and Review and
Improving Regulation and Regulatory Review
This final 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 as 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 final rule is not a ``significant regulatory action'' under
E.O. 12866, section 3(f).
Analysis of Benefits and Costs
DEA has examined the benefits and costs of this final rule.
Currently, based on submissions received in 2018, 99.5 percent of all
DEA Form 106 reports are reported electronically via DEA's secure
website. This final rule impacts the remaining 0.5 percent of responses
that are reported by paper, representing 181 of a total of 37,047
responses. Benefits include costs savings, as discussed in the
following paragraphs, increased simplicity in reporting theft and loss
on controlled substances, and clarity in the regulations. This final
rule adds clarity to the submission method by matching the electronic
submission process to that of ``Reports of Loss or Disappearance of
Listed Chemicals''--DEA Form 107. Additionally, electronic submissions
will allow all report submissions to be received more quickly and
stored in a central database, as well as allow for analysis.
There is no new cost associated with this final rule. The labor
burden to submit DEA Form 106 is estimated to be the same for
electronic and paper submissions. However, DEA anticipates there will
be cost savings associated with electronic submissions. Some cost
savings are described qualitatively and some are quantified. Based on
submissions received in 2018, DEA estimates approximately 181 paper
submissions per year. Many of these
[[Page 40711]]
paper forms contain illegible or erroneous information, requiring DEA
to call respondents to correct or clarify the information in the paper
form, consuming both DEA's and the respondent's time and resources.
Electronic submissions are expected to virtually eliminate the
requirement for DEA to call back respondents for clarifications of form
data. As DEA has not tracked the number of call backs or the average
duration of calls, DEA does not have a strong basis to quantify the
cost savings.
This final rule eliminates the need to print paper forms and
transmit by mail or courier service. DEA estimates there will be a cost
savings of $0.63, $0.55 for postage plus $0.08 for an envelope, or a
total of $114 per year for an estimated 181 responses per year. DEA
assumes the cost savings associated with not having to print is
negligible. In summary, DEA estimates the economic impact of this final
rule is de minimis.
In the event particular registrants feel the need to request an
exception from the electronic submission requirement, they can write
DEA to request an exception to regulations pursuant to 21 CFR 1307.03.
In the event of any technical issues involving the network being down
or otherwise unable to submit DEA Form 106 online, the registrant can
report the issues by calling the DEA Help Center at 1-800-882-9539.
Executive Order 12988, Civil Justice Reform
This final regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to
eliminate drafting errors and ambiguity, minimize litigation, provide a
clear legal standard for affected conduct, and promote simplification
and burden reduction.
Executive Order 13132, Federalism
This final rule does not have federalism implications warranting
the application of E.O. 13132. The final rule does not have substantial
direct effects on the States, on the relationship between the National
Government and the States, or the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This final rule does not have tribal implications warranting the
application of E.O. 13175. This final 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), 5 U.S.C.
601-612, DEA has reviewed the economic impact of this final rule on
small entities. DEA's economic impact evaluation indicates that the
rule will not have a significant economic impact on a substantial
number of small entities.
The RFA requires agencies to analyze options for regulatory relief
of small entities unless it can certify that the rule will not have a
significant impact on a substantial number of small entities. For the
purposes of the RFA, small entities include small businesses, nonprofit
organizations, and small governmental jurisdictions. DEA has analyzed
the economic impact of each provision of this final rule and estimates
that the final rule will have minimal economic impact on affected
entities, including small entities.
The final rule amends regulations regarding DEA Form 106 to clarify
that all submissions of the form must be submitted online. Based on
actual submissions in 2018, DEA estimates there are 181 paper
submissions per year, submitted by six entities: One distributor, two
pharmacies, one researcher, one veterinarian service entity, and one
hospital.
DEA estimates the affected entities are in the following North
American Industry Classification System (NAICS) industries:
[ssquf] 424210--Drugs and Druggist's Sundries Merchant Wholesalers
[ssquf] 446110--Pharmacies and Drug Stores
[ssquf] 541712--Research and Development in the Physical, Engineering,
and Life Sciences (except Biotechnology)
[ssquf] 541940--Veterinary Services
[ssquf] 622110--General Medical and Surgical Hospitals
The U.S. Census Bureau's Statistics of U.S. Businesses (SUSB) is an
annual series that provides economic data by enterprise size and
industry. SUSB data contains the number of firms for various employment
or revenue size ranges for each industry. Comparing the size ranges to
the U.S. Small Business Administration (SBA) size standards, DEA
estimated the number of entities in each affected industry, number of
small entities in each affected industry, and number of affected small
entities. The table below summarizes the results.
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Number of
NAICS Description Number of SBA size standards Number of affected small
firms small entities entities
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424210............ Drugs and Druggists' 6,833 250 employees............ 6,569 0
Sundries Merchant
Wholesalers.
446110............ Pharmacies and Drug 18,852 $30.0 million *.......... 18,503 0
Stores.
541715............ Research and 9,864 1,000 employees.......... 9,325 0
Development in the
Physical,
Engineering, and Life
Sciences (except
Biotechnology).
541940............ Veterinary Services... 27,708 $8.0 million *........... 27,564 1
622110............ General Medical and 2,904 $41.5 million *.......... 1,199 0
Surgical Hospitals.
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* Annual revenue.
Sources: 2016 SUSB Annual Datasets by Establishment Industry, ``U.S. & states, NAICS, detailed employment sizes
(U.S., 6-digit and states, NAICS sectors).'' https://www.census.gov/data/datasets/2016/econ/susb/2016-susb.html. (Accessed 1/14/2020.) 2012 SUSB Annual Data Tables by Establishment Industry, ``U.S., 6-digit
NAICS.'' https://www.census.gov/data/tables/2012/econ/susb/2012-susb-annual.html. (Accessed 1/14/2020.) U.S.
Small Business Administration, Table of size standards, effective Aug 19, 2019. https://www.sba.gov/document/support--table-size-standards. (Accessed 1/14/2020.)
There is no new cost associated with this final rule. The labor
burden to submit DEA Form 106 is estimated to be the same for
electronic and paper submissions. However, DEA anticipates there will
be cost savings associated with electronic submissions. Some cost
savings are described qualitatively and some are quantified. From
submissions received in 2018, DEA estimates the one affected small
entity submits one paper submission per year. Many of these paper forms
contain illegible or erroneous information, requiring DEA to call
respondents to correct or clarify the information in the paper form,
consuming DEA's and the respondent's time and resources. Electronic
submissions are expected to virtually eliminate the requirement for DEA
to call back the respondent for clarifications of form data. As DEA has
not tracked the number of call backs or the average duration of calls,
DEA does not have a strong basis to quantify the cost savings.
[[Page 40712]]
DEA estimates there will be a cost saving associated with
eliminating the need to print paper forms and transmit by mail or
courier service. The estimated cost savings is $0.63, $0.55 for postage
plus $0.08 for an envelope, per paper submission.
In summary, DEA estimates this rule will affect six entities who
submit 181 paper DEA Form 106's. Of the affected six entities, one
entity (veterinary services entity) is a small entity, submitting one
paper form per year. The estimated cost savings for the affected small
entity is minimal ($0.63 per year). Therefore, this final rule will not
have a significant economic impact on a substantial number of small
entities.
Unfunded Mandates Reform Act of 1995
On the basis of information contained in the RFA section above, DEA
has determined and certifies pursuant to the Unfunded Mandates Reform
Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., 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 provisions of UMRA.
Paperwork Reduction Act
Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521), DEA has identified that this final rule modifies an existing
collection of information: 1117-0001. A person is not required to
respond to a collection of information unless it displays a valid OMB
control number. Copies of existing information collections approved by
OMB may be obtained at https://www.reginfo.gov/.
A. Collections of Information Associated With the Final Rule
Title: Amending Regulations Regarding DEA Form 106.
OMB Control Number: 1117-0001.
Form Number: DEA-106.
DEA is amending its regulations for reporting thefts or significant
losses of controlled substances to implement the requirement of
electronic submissions for reporting the thefts or significant losses
of controlled substances to clarify that all such reports must be
submitted electronically within 45 days of discovery of the
circumstances requiring the report. This amendment clarifies the
submission process by aligning it with the current electronic
submission requirements of reporting losses of disappearance of listed
chemicals on DEA Form 107 and no longer accepting physical copies. Form
107 (OMB Control Number 1117-0024) is also only submitted
electronically; however, the reporting time frame for Form 107 is
within 15 days of discovery of the circumstances requiring the report
instead of the 45-day time frame, finalized in this rule, for DEA Form
106.
Currently, based on 2018 submission data, 99.5 percent of all DEA
Form 106 reports are reported electronically via DEA's secure website.
This final rule impacts the remaining 0.5 percent of responses that are
reported by paper. Electronic submissions are expected to virtually
eliminate the requirement for DEA to call back the respondent for
clarifications of form data. Furthermore, this final rule eliminates
the need for respondents to print paper forms and transmit by mail or
courier service, resulting in cost savings for the 0.5 percent of
responses per year transitioning from paper to electronic forms.
The electronic submission must be filed with DEA through DEA's
Diversion Control Division secure network application (available on
DEA's Diversion Control Division website). The submissions of forms
will be more easily submitted and organized through the secure
database.
DEA estimates the following number of respondents and burden
associated with this collection of information:
[ssquf] Number of respondents: 10,693.
[ssquf] Frequency of response: 3.4646 (calculated).
[ssquf] Number of responses: 37,047.
[ssquf] Burden per response: 0.3333 hours.
[ssquf] Total annual hour of burden: 12,349 hours.
If you need a copy of the information collection instrument(s) with
instructions or additional information, please contact the Regulatory
Drafting and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 776-2265.
Any additional comments on this collection of information, may be
sent in writing to the Office of Information and Regulatory Affairs,
OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please
state that your comment refers to OMB Control Number 1117-0001.
Congressional Review Act
This final rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is
submitting a copy of this rule to both Houses of Congress and to the
Comptroller General.
List of Subjects in 21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
For the reasons set out above, DEA amends 21 CFR part 1301 as
follows:
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1301 continues to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877,
886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.
0
2. In Sec. 1301.74, revise the fifth sentence of paragraph (c)
introductory text to read as follows:
Sec. 1301.74 Other security controls for non-practitioners; narcotic
treatment programs and compounders for narcotic treatment programs.
* * * * *
(c) * * * The registrant must also file a complete and accurate DEA
Form 106 with the Administration through the DEA Diversion Control
Division secure network application within 45 calendar days after
discovery of the theft or loss. * * *
* * * * *
0
3. In Sec. 1301.76, revise the second sentence of paragraph (b)
introductory text to read as follows:
Sec. 1301.76 Other security controls for practitioners.
* * * * *
(b) * * * The registrant must also file a complete and accurate DEA
Form 106 with the Administration through DEA's Diversion Control
Division secure network application within 45 days after discovery of
the theft or loss. * * *
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
June 14, 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
[[Page 40713]]
document upon publication in the Federal Register.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-13085 Filed 6-21-23; 8:45 am]
BILLING CODE 4410-09-P