Reporting of Theft or Significant Loss of Controlled Substances, 45547-45551 [2020-15635]
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Federal Register / Vol. 85, No. 146 / Wednesday, July 29, 2020 / Proposed Rules
have a substantial direct effect 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.
For the reasons discussed above, I
certify this proposed regulation:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866,
(2) Will not affect intrastate aviation
in Alaska, and
(3) Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
The Proposed Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):
■
Textron Aviation Inc. (Type Certificate
previously held by Beechcraft
Corporation): Docket No. FAA–2020–
0718; Product Identifier 2019–CE–045–
AD.
(a) Comments Due Date
The FAA must receive comments by
September 14, 2020.
(b) Affected ADs
None.
(c) Applicability
This AD applies to the Textron Aviation
Inc. (type certificate previously held by
Beechcraft Corporation) airplanes,
certificated in any category, identified in
table 1 to paragraph (c) of this AD:
TABLE 1 TO PARAGRAPH (c) OF THIS
AD—APPLICABILITY
Serial numbers
(S/Ns)
Models
F90 ............................
65–90, 65–A90, B90,
C90.
H90 (T–44A) .............
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LA–2 through LA–
225.
All S/Ns.
LL–1 through LL–61.
16:12 Jul 28, 2020
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TABLE 1 TO PARAGRAPH (c) OF THIS
AD—APPLICABILITY—Continued
Models
E90 ............................
65–A90–1 (JU–21A,
U–21A, RU–21A,
RU–21D, U–21G,
RU–21H).
65–A90–2 (RU–21B)
65–A90–3 (RU–21C)
65–A90–4 (RU–21E,
RU–21H).
99, 99A, 99A (FACH),
A99, A99A, B99,
C99.
100, A100 (U–21F) ...
B100 ..........................
Serial numbers
(S/Ns)
LW–1 through LW–
347.
LM–1 through LM–
144.
LS–1, LS–2, LS–3.
LT–1 and LT–2.
LU–1 through LU–16.
U–1 through U–239.
B–1 through B–247.
BE–1 through BE–
137.
(d) Subject
Joint Aircraft System Component (JASC):
5700, Wings.
(e) Unsafe Condition
This AD was prompted by information
provided by Textron Aviation Inc. that a
washer assembly may provide premature
torque indication that could lead to cracking
of the wing fitting. The FAA is issuing this
AD to prevent such fatigue cracks. The
unsafe condition, if not addressed, could
result in failure of the forward lower wing
fitting, which could lead to wing separation
and loss of airplane control.
(f) Compliance
Comply with this AD within the
compliance times specified below, unless
already done.
(g) Action
Frm 00003
(h) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Wichita ACO Branch,
FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures
found in 14 CFR 39.19. Send information to
ATTN: Brian C. Adamson, Aerospace
Engineer, Wichita ACO Branch, AIR–7K3,
FAA, 1801 Airport Rd, Wichita, KS 67209;
phone: 316–946–4193; fax: 316–946–4107;
email: brian.adamson@faa.gov or WichitaCOS@faa.gov. Before using any approved
AMOC on any airplane to which the AMOC
applies, notify your appropriate principal
inspector (PI) in the FAA Flight Standards
District Office (FSDO), or lacking a PI, your
local FSDO.
(i) Related Information
(1) For more information about this AD,
contact Brian C. Adamson, Aerospace
Engineer, Wichita ACO Branch, AIR–7K3,
FAA, 1801 Airport Rd, Wichita, KS 67209;
phone: 316–946–4193; fax: 316–946–4107;
email: brian.adamson@faa.gov or WichitaCOS@faa.gov.
(2) For service information identified in
this AD, contact Textron Aviation Inc., PO
Box 7706, Wichita, KS 67277: phone: 316–
517–5800: internet: https://txtav.com/. You
may view this service information at the
FAA, Airworthiness Products Section,
Operational Safety Branch, 901 Locust St,
Kansas City, MO 64106. For information on
the availability of this material at the FAA,
call 816–329–4148.
Issued on July 22, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020–16214 Filed 7–28–20; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
(1) Within the next 200 flight hours after
the effective date of this AD or within 12
months after the effective date of this AD,
whichever occurs later, inspect each washer
assembly attached to the left and right lower
forward wing bolts and remove all part
number 90–380058–1 washers in accordance
with the Accomplishment Instructions,
paragraphs 3 through 5, of Beechcraft
Mandatory Service Letter MTL–57–01,
Revision 1, dated September 19, 2018 (MTL–
57–01). In all locations where a washer part
number 90–380058–1 was removed, do the
following:
(i) Inspect the bolt, nut, and fitting in
accordance with the Accomplishment
Instructions, paragraph 6, of MTL–57–01. If
there is a crack in the fitting, replace the
fitting before further flight.
(ii) Install a part number 90–380019–1
washer in accordance with the
Accomplishment Instructions, paragraph 7,
of MTL–57–01.
(2) As of the effective date of this AD, do
not install washer part number 90–380058–
1 on any airplane listed in table 1 to
paragraph (c) of this AD.
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Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA–574]
RIN 1117–AB57
Reporting of Theft or Significant Loss
of Controlled Substances
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
This proposed rule would
amend Drug Enforcement
Administration (DEA) regulations
regarding DEA Form 106, used by DEA
registrants to report thefts or significant
losses of controlled substances, to
clarify that all such forms must be
submitted electronically. In addition,
the proposed rule would add new
requirements for the form to be
submitted accurately and within a 15day time period. This proposed rule will
SUMMARY:
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Federal Register / Vol. 85, No. 146 / Wednesday, July 29, 2020 / Proposed Rules
not change the requirement that
registrants 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 discovery of such loss
or theft.
DATES: Comments must be submitted
electronically or postmarked on or
before September 28, 2020. 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 collection
of information under the Paperwork
Reduction Act must be submitted to the
Office of Management and Budget
(OMB) on or before September 28, 2020.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–574’’ on all electronic and
written correspondence, including any
attachments.
• Electronic comments: The Drug
Enforcement Administration 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.
• Paperwork Reduction Act
Comments: All comments concerning
collections of information under the
Paperwork Reduction Act must be
submitted to the Office of Information
and Regulatory Affairs, OMB, Attention:
Desk Officer for DOJ, 725 17th Street
NW, Washington, DC 20503. Please state
that your comment refers to RIN 1117–
AB57/Docket No. DEA–547.
FOR FURTHER INFORMATION CONTACT:
Scott A. Brinks, Regulatory Drafting and
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Policy Support Section (DPW),
Diversion Control Division, Drug
Enforcement Administration; Mailing
Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone:
(571) 362–3261.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments
received in response to this docket 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
directed above as confidential.
An electronic copy of this proposed
rule is available at https://
www.regulations.gov for easy reference.
Background and Legal Authority
The Controlled Substances Act (CSA)
authorizes the Administrator of DEA (by
delegation from the Attorney General) to
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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; and for the efficient
execution of his statutory functions. 21
U.S.C. 821, 827, 871(b). Currently, 21
CFR 1301.74(c) requires a nonpractitioner registrant to notify DEA’s
Field Division Office in his or her area,
in writing, of any theft or significant
loss of any controlled substances within
one business day upon discovery of
such theft or loss. The provision
stipulates this same notification
requirement and one-day time period
regarding in-transit losses of controlled
substances for suppliers, importers, and
exporters with certain exceptions. In
addition to the requirement to notify
DEA within one business day of the
discovery of a theft or loss, this
provision requires a non-practitioner
registrant to complete and submit to the
same field division office a DEA Form
106 regarding the theft or loss. This
provision is silent as to the actual
submission method of the DEA Form
106 (e.g., mail, hand delivery,
electronic) and the time period in which
these reports are due. This proposed
rule will not change the requirement
that registrants notify the Field Division
Office of the Administration in their
area, in writing, of the theft or
significant loss of any controlled
substances within one business day of
discovery of such loss or theft.
Similarly, 21 CFR 1301.76(b)
currently requires practitioner
registrants to notify DEA’s Field
Division Office in his area, in writing,
of the theft or significant loss of any
controlled substances within one
business day upon discovery of the theft
or loss; and to complete and submit
DEA Form 106 to the same Field
Division Office. Again, this provision is
silent as to the actual submission
method of DEA Form 106 and the due
date for this report.
This proposed rule will not change
the requirement under 21 CFR
1301.74(c) and 1301.76(b), respectively,
that non-practitioner and practitioner
registrants notify DEA’s Field Division
Office in their area, in writing, of the
theft or significant loss of any controlled
substances within one business day of
discovery of such loss or theft.
Currently, 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.
See Regulatory Analyses section for
additional information.
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Federal Register / Vol. 85, No. 146 / Wednesday, July 29, 2020 / Proposed Rules
Amendments To Revise Submission
Process for DEA Form 106
This proposed rule would set a 15-day
calendar period for submitting a
complete and accurate DEA Form 106
and clarify the form submission process,
requiring all forms be submitted
electronically. This would match the
submission process for DEA Form 107,
a form used by regulated persons 1 to
report loss or disappearance of listed
chemicals. As set forth in 21 CFR
1310.05(b)(1), a regulated person must
file a complete and accurate DEA Form
107 with DEA through the DEA
Diversion Control Diversion secure
network application (available on the
DEA Diversion Control Division
website) within 15 calendar days after
discovery of the circumstances requiring
the report.
These proposed changes would make
clear to registrants that all DEA Form
106 submissions must go through the
secure online database, and physical
copies will no longer be accepted.
Through the secure online database,
forms will be more easily submitted and
organized.2
Regulatory Analyses
Executive Orders 12866, 13563, and
13771, Regulatory Planning and Review,
Improving Regulation and Regulatory
Review, and Reducing Regulation and
Controlling Regulatory Costs
This proposed rule was developed in
accordance with the principles of
Executive Orders (E.O.s) 12866, 13563,
and 13771. 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
1 The term ‘‘regulated person’’ is defined at 21
U.S.C. 802(38).
2 https://www.deadiversion.usdoj.gov/21cfr_
reports/theft/.
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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. DEA
has determined that this proposed 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 proposed rule. Currently,
99.5 percent of all DEA Form 106
reports are reported electronically via
DEA’s secure website. This proposed
rule will impact 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, and increased simplicity in
reporting theft and loss on controlled
substances and clarity in the
regulations. This proposed rule will add
clarity to the submission method by
matching the submission process and
requirements for ‘‘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 proposed 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
approximately 181 paper submissions
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 both 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.
This proposed rule would eliminate
the need to print paper forms and
transmit by mail or courier service. DEA
estimates there will be a cost savings of
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45549
$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 proposed rule
is de minimis.
E.O. 13771 was issued on January 30,
2017, and published in the Federal
Register on February 3, 2017.3 Section
2(a) of E.O. 13771 requires an agency,
unless prohibited by law, to identify at
least two existing regulations to be
repealed when the agency publicly
proposes for notice and comment or
otherwise promulgates a new regulation.
In furtherance of this requirement,
Section 2(c) of E.O. 13771 requires that
the new incremental costs associated
with new regulations, to the extent
permitted by law, be offset by the
elimination of existing costs associated
with at least two prior regulations. DEA
expects this proposed rule will not be
considered an E.O. 13771 regulatory
action. The estimated economic impact
of proposed rule is de minimis.
Executive Order 12988, Civil Justice
Reform
This proposed 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 proposed rulemaking 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 the
distribution of power and
responsibilities among the various
levels of government.
Executive Order 13175, Consultation
and Coordination With Indian Tribal
Governments
This proposed rule does not have
tribal implications warranting the
application of E.O. 13175. This
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.
3 82
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Regulatory Flexibility Act
In accordance with the Regulatory
Flexibility Act (RFA), 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 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 proposed rule and estimates that
the proposed rule will have minimal
economic impact on affected entities,
including small entities.
This proposed rule would amend
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:
• 424210—Drugs and Druggists’
Sundries Merchant Wholesalers
• 446110—Pharmacies and Drug
Stores
• 541712—Research and
Development in the Physical,
Engineering, and Life Sciences (except
Biotechnology)
• 541940—Veterinary Services
• 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
small entities
Number of
affected small
entities
NAICS
Description
Number of firms
SBA size standards
424210 ......
Drugs and Druggists’ Sundries Merchant
Wholesalers.
Pharmacies and Drug Stores .........................
Research and Development in the Physical,
Engineering, and Life Sciences (except
Biotechnology).
Veterinary Services .........................................
General Medical and Surgical Hospitals ........
6,833 ..........................
250 employees ...........
6,569
0
18,852 ........................
9,864 ..........................
$30.0 million * .............
1,000 employees ........
18,503
9,325
0
0
27,708 ........................
2,904 ..........................
$8.0 million * ...............
$41.5 million * .............
27,564
1,199
1
0
446110 ......
541715 ......
541940 ......
622110 ......
* 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-sizestandards. (Accessed 1/14/2020.)
There is no new cost associated with
this proposed 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.
DEA estimates there will be a cost
saving associated with eliminating the
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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 Forms 106. 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 proposed rule, if
promulgated, 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 ‘‘Regulatory Flexibility Act’’
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
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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 (PRA) (44 U.S.C. 3501–
3521), DEA has identified the following
collection of information related to this
proposed rule. This action would
modify existing collection 1117–0001
and DEA will be submitting the revision
to OMB for approval. 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/. DEA has submitted
this collection request to OMB for
review and approval.
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Federal Register / Vol. 85, No. 146 / Wednesday, July 29, 2020 / Proposed Rules
A. Collections of Information Associated
With the Proposed Rule
Title: Amending Regulations
Regarding DEA Form 106
OMB Control Number: 1117–0001
Form Number: DEA–106
DEA is proposing to amend 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 15 days of
discovery of the circumstances requiring
the report. This amendment would
clarify the submission process by
aligning it with the current
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, within 15 days
of discovery of the circumstances
requiring the report.
Currently, 99.5 percent of all DEA
Form 106 reports are reported
electronically via DEA’s secure website.
This proposed rule will impact 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 proposed rule would eliminate 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 would be
filed with DEA through the DEA
Diversion Control Diversion secure
network application (available on the
DEA Diversion Control Division
website). The submissions of forms will
be more easily submitted and organized
through the secure database.
The DEA estimates the following
number of respondents and burden
associated with this collection of
information:
• Number of respondents: 10,693.
• Frequency of response: 3.4646
(calculated).
• Number of responses: 37,047.
• Burden per response: 0.3333 hours.
• Total annual hour burden: 12,349
hours.
B. Request for Comments Regarding the
Proposed Collections of Information
Written comments and suggestions
from the public and affected entities
VerDate Sep<11>2014
16:12 Jul 28, 2020
Jkt 250001
45551
concerning the proposed revision of this
collection of information are
encouraged. Under the PRA, DEA is
required to provide a notice regarding
the proposed collections of information
in the Federal Register with the notice
of proposed rulemaking and solicit
public comment. Pursuant to section
3506(c)(2) of the PRA (44 U.S.C.
3506(c)(2)), DEA is soliciting comment
on the following issues related to this
information of collection:
• 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.
Please send written comments to the
Office of Information and Regulatory
Affairs, OMB, Attention: Desk Officer
for DOJ, 725 17th Street NW,
Washington, DC 20503. Please state that
your comments refer to RIN 1117–
AB57/Docket No. DEA–574. All
comments must be submitted to OMB
on or before September 28, 2020. 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
22152–2639; Telephone: (571) 362–
3261.
Authority: 21 U.S.C. 821, 822, 823, 824,
831, 871(b), 875, 877, 886a, 951, 952, 956,
957, 958, 965 unless otherwise noted.
List of Subjects in 21 CFR Part 1301
Administrative practice and
procedure, Drug traffic control, Security
measures.
For the reasons set out above, the DEA
proposes to amend 21 CFR part 1301 as
follows:
AGENCY:
PART 1301—REGISTRATION OF
MANUFACTURERS, DISTRIBUTORS,
AND DISPENSERS OF CONTROLLED
SUBSTANCES
1. The authority citation for part 1301
continues to read as follows:
■
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
2. In § 1301.74, revise the fifth
sentence of paragraph (c) introductory
text to read as follows:
■
§ 1301.74 Other security controls for nonpractitioners; 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 15 calendar
days after discovery of the theft or loss.
* * *
*
*
*
*
*
■ 3. In § 1301.76, revise the second
sentence of paragraph (b) introductory
text to read as follows:
§ 1301.76 Other security controls for
practitioners.
*
*
*
*
*
(b) * * * 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 15 calendar
days after the discovery of theft or loss.
* * *
*
*
*
*
*
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020–15635 Filed 7–28–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 31
[REG–111879–20]
RIN 1545–BP88
Recapture of Excess Employment Tax
Credits Under the Families First Act
and the CARES Act
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of Proposed Rulemaking
by cross-reference to temporary
regulations.
In the Rules and Regulations
section of this issue of the Federal
Register, the IRS is issuing temporary
regulations pursuant to the regulatory
authority granted under the Families
First Coronavirus Response Act and the
Coronavirus Aid, Relief, and Economic
Security Act to prescribe such
regulations as may be necessary for
SUMMARY:
E:\FR\FM\29JYP1.SGM
29JYP1
]]>Agencies
[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Proposed Rules]
[Pages 45547-45551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15635]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA-574]
RIN 1117-AB57
Reporting of Theft or Significant Loss of Controlled Substances
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would amend Drug Enforcement Administration
(DEA) regulations regarding DEA Form 106, used by DEA registrants to
report thefts or significant losses of controlled substances, to
clarify that all such forms must be submitted electronically. In
addition, the proposed rule would add new requirements for the form to
be submitted accurately and within a 15-day time period. This proposed
rule will
[[Page 45548]]
not change the requirement that registrants 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 discovery
of such loss or theft.
DATES: Comments must be submitted electronically or postmarked on or
before September 28, 2020. 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 collection of information under the
Paperwork Reduction Act must be submitted to the Office of Management
and Budget (OMB) on or before September 28, 2020.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-574'' on all electronic and written correspondence,
including any attachments.
Electronic comments: The Drug Enforcement Administration
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.
Paperwork Reduction Act Comments: All comments concerning
collections of information under the Paperwork Reduction Act must be
submitted to the Office of Information and Regulatory Affairs, OMB,
Attention: Desk Officer for DOJ, 725 17th Street NW, Washington, DC
20503. Please state that your comment refers to RIN 1117-AB57/Docket
No. DEA-547.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, 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.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
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 directed above as confidential.
An electronic copy of this proposed rule is available at https://www.regulations.gov for easy reference.
Background and Legal Authority
The Controlled Substances Act (CSA) authorizes the Administrator of
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; and for the
efficient execution of his statutory functions. 21 U.S.C. 821, 827,
871(b). Currently, 21 CFR 1301.74(c) requires a non-practitioner
registrant to notify DEA's Field Division Office in his or her area, in
writing, of any theft or significant loss of any controlled substances
within one business day upon discovery of such theft or loss. The
provision stipulates this same notification requirement and one-day
time period regarding in-transit losses of controlled substances for
suppliers, importers, and exporters with certain exceptions. In
addition to the requirement to notify DEA within one business day of
the discovery of a theft or loss, this provision requires a non-
practitioner registrant to complete and submit to the same field
division office a DEA Form 106 regarding the theft or loss. This
provision is silent as to the actual submission method of the DEA Form
106 (e.g., mail, hand delivery, electronic) and the time period in
which these reports are due. This proposed rule will not change the
requirement that registrants notify the Field Division Office of the
Administration in their area, in writing, of the theft or significant
loss of any controlled substances within one business day of discovery
of such loss or theft.
Similarly, 21 CFR 1301.76(b) currently requires practitioner
registrants to notify DEA's Field Division Office in his area, in
writing, of the theft or significant loss of any controlled substances
within one business day upon discovery of the theft or loss; and to
complete and submit DEA Form 106 to the same Field Division Office.
Again, this provision is silent as to the actual submission method of
DEA Form 106 and the due date for this report.
This proposed rule will not change the requirement under 21 CFR
1301.74(c) and 1301.76(b), respectively, that non-practitioner and
practitioner registrants notify DEA's Field Division Office in their
area, in writing, of the theft or significant loss of any controlled
substances within one business day of discovery of such loss or theft.
Currently, 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. See Regulatory
Analyses section for additional information.
[[Page 45549]]
Amendments To Revise Submission Process for DEA Form 106
This proposed rule would set a 15-day calendar period for
submitting a complete and accurate DEA Form 106 and clarify the form
submission process, requiring all forms be submitted electronically.
This would match the submission process for DEA Form 107, a form used
by regulated persons \1\ to report loss or disappearance of listed
chemicals. As set forth in 21 CFR 1310.05(b)(1), a regulated person
must file a complete and accurate DEA Form 107 with DEA through the DEA
Diversion Control Diversion secure network application (available on
the DEA Diversion Control Division website) within 15 calendar days
after discovery of the circumstances requiring the report.
---------------------------------------------------------------------------
\1\ The term ``regulated person'' is defined at 21 U.S.C.
802(38).
---------------------------------------------------------------------------
These proposed changes would make clear to registrants that all DEA
Form 106 submissions must go through the secure online database, and
physical copies will no longer be accepted. Through the secure online
database, forms will be more easily submitted and organized.\2\
---------------------------------------------------------------------------
\2\ https://www.deadiversion.usdoj.gov/21cfr_reports/theft/.
---------------------------------------------------------------------------
Regulatory Analyses
Executive Orders 12866, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs
This proposed rule was developed in accordance with the principles
of Executive Orders (E.O.s) 12866, 13563, and 13771. 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. DEA has
determined that this proposed 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 proposed rule.
Currently, 99.5 percent of all DEA Form 106 reports are reported
electronically via DEA's secure website. This proposed rule will impact
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, and increased
simplicity in reporting theft and loss on controlled substances and
clarity in the regulations. This proposed rule will add clarity to the
submission method by matching the submission process and requirements
for ``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 proposed 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 approximately 181 paper
submissions 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 both 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.
This proposed rule would eliminate 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 proposed rule
is de minimis.
E.O. 13771 was issued on January 30, 2017, and published in the
Federal Register on February 3, 2017.\3\ Section 2(a) of E.O. 13771
requires an agency, unless prohibited by law, to identify at least two
existing regulations to be repealed when the agency publicly proposes
for notice and comment or otherwise promulgates a new regulation. In
furtherance of this requirement, Section 2(c) of E.O. 13771 requires
that the new incremental costs associated with new regulations, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations. DEA expects this
proposed rule will not be considered an E.O. 13771 regulatory action.
The estimated economic impact of proposed rule is de minimis.
---------------------------------------------------------------------------
\3\ 82 FR 9339.
---------------------------------------------------------------------------
Executive Order 12988, Civil Justice Reform
This proposed 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 proposed rulemaking 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 the distribution of
power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed rule does not have tribal implications warranting the
application of E.O. 13175. This 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.
[[Page 45550]]
Regulatory Flexibility Act
In accordance with the Regulatory Flexibility Act (RFA), 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 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 proposed rule and
estimates that the proposed rule will have minimal economic impact on
affected entities, including small entities.
This proposed rule would amend 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:
424210--Drugs and Druggists' Sundries Merchant Wholesalers
446110--Pharmacies and Drug Stores
541712--Research and Development in the Physical,
Engineering, and Life Sciences (except Biotechnology)
541940--Veterinary Services
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 firms SBA size standards Number of affected small
small entities entities
--------------------------------------------------------------------------------------------------------------------------------------------------------
424210............................... Drugs and Druggists' Sundries 6,833................... 250 employees........... 6,569 0
Merchant Wholesalers.
446110............................... Pharmacies and Drug Stores... 18,852.................. $30.0 million *......... 18,503 0
541715............................... Research and Development in 9,864................... 1,000 employees......... 9,325 0
the Physical, Engineering,
and Life Sciences (except
Biotechnology).
541940............................... Veterinary Services.......... 27,708.................. $8.0 million *.......... 27,564 1
622110............................... General Medical and Surgical 2,904................... $41.5 million *......... 1,199 0
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 proposed 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.
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 Forms 106. 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 proposed rule, if
promulgated, 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 ``Regulatory
Flexibility Act'' 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 (PRA) (44 U.S.C.
3501-3521), DEA has identified the following collection of information
related to this proposed rule. This action would modify existing
collection 1117-0001 and DEA will be submitting the revision to OMB for
approval. 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/. DEA has submitted this collection request to
OMB for review and approval.
[[Page 45551]]
A. Collections of Information Associated With the Proposed Rule
Title: Amending Regulations Regarding DEA Form 106
OMB Control Number: 1117-0001
Form Number: DEA-106
DEA is proposing to amend 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 15 days of discovery of
the circumstances requiring the report. This amendment would clarify
the submission process by aligning it with the current 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, within 15 days of
discovery of the circumstances requiring the report.
Currently, 99.5 percent of all DEA Form 106 reports are reported
electronically via DEA's secure website. This proposed rule will impact
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 proposed rule would eliminate 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 would be filed with DEA through the DEA
Diversion Control Diversion secure network application (available on
the DEA Diversion Control Division website). The submissions of forms
will be more easily submitted and organized through the secure
database.
The DEA estimates the following number of respondents and burden
associated with this collection of information:
Number of respondents: 10,693.
Frequency of response: 3.4646 (calculated).
Number of responses: 37,047.
Burden per response: 0.3333 hours.
Total annual hour burden: 12,349 hours.
B. Request for Comments Regarding the Proposed Collections of
Information
Written comments and suggestions from the public and affected
entities concerning the proposed revision of this collection of
information are encouraged. Under the PRA, DEA is required to provide a
notice regarding the proposed collections of information in the Federal
Register with the notice of proposed rulemaking and solicit public
comment. Pursuant to section 3506(c)(2) of the PRA (44 U.S.C.
3506(c)(2)), DEA is soliciting comment on the following issues related
to this information of collection:
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.
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, 725 17th
Street NW, Washington, DC 20503. Please state that your comments refer
to RIN 1117-AB57/Docket No. DEA-574. All comments must be submitted to
OMB on or before September 28, 2020. 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 22152-2639;
Telephone: (571) 362-3261.
List of Subjects in 21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
For the reasons set out above, the DEA proposes to amend 21 CFR
part 1301 as follows:
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
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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.
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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 15 calendar days after
discovery of the theft or loss. * * *
* * * * *
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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 the DEA Diversion Control
Division secure network application within 15 calendar days after the
discovery of theft or loss. * * *
* * * * *
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-15635 Filed 7-28-20; 8:45 am]
BILLING CODE 4410-09-P
