Reporting Theft or Significant Loss of Controlled Substances, 40707-40713 [2023-13085]

Agencies

• Drug Enforcement Administration
• Department of Justice

[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \3\ The term ``regulated person'' is defined at 21 U.S.C. 
802(38).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \4\ 85 FR 45547.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \5\ 85 FR 45547, 45549.
    \6\ 21 CFR 1310.05(b)(1).
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \7\ 21 CFR 1301.71(a).
    \8\ 21 CFR 1304.21(a).
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \9\ 21 CFR 1301.71(a).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \10\ 70 FR 47094, 47095, August 12, 2005.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \11\ 21 CFR 1301.74(c).
---------------------------------------------------------------------------

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.

----------------------------------------------------------------------------------------------------------------
                                                                                                     Number of
       NAICS              Description       Number of      SBA size standards        Number of    affected small
                                              firms                               small entities     entities
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
* 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