Clarification Regarding the Supplier's DEA Registration Number on the Single-Sheet DEA Form 222
| Published date | 20 July 2021 |
| Citation | 86 FR 38230 |
| Record Number | 2021-15323 |
| Section | Rules and Regulations |
| Court | Drug Enforcement Administration |
Federal Register, Volume 86 Issue 136 (Tuesday, July 20, 2021)
[Federal Register Volume 86, Number 136 (Tuesday, July 20, 2021)]
[Rules and Regulations]
[Pages 38230-38232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15323]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1305
[Docket No. DEA-662]
RIN 1117-AB61
Clarification Regarding the Supplier's DEA Registration Number on
the Single-Sheet DEA Form 222
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Direct final rule.
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SUMMARY: The Drug Enforcement Administration (DEA) is issuing this
direct final rule to amend DEA regulations to clarify that either the
purchaser or the supplier may enter a supplier's DEA registration
number on the Single-Sheet DEA Form 222.
DATES: This direct final rule is effective on October 18, 2021 without
further action, unless significant adverse comment is received by
August 19, 2021. If the Drug Enforcement Administration (DEA) receives
significant adverse comment, it will publish a withdrawal of the rule
in the Federal Register by September 20, 2021. Electronic comments must
be submitted, and written comments must be postmarked, on or before
August 19, 2021. Commenters should be aware that the electronic Federal
Docket Management System will not accept comments after 11:59 p.m.
Eastern Time on the last day of the comment period.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-662'' on all correspondence, including any
attachments.
Electronic comments: DEA encourages that all comments be submitted
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 http://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 an electronic
submission are not necessary and are discouraged. 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,
Attention: DEA Federal Register Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 776-2265.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received are considered part of the
public record. They will, unless reasonable cause is given, be made
available by the Drug Enforcement Administration (DEA) for public
inspection online at http://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 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
confidential business information to be redacted within the comment.
Comments containing personal identifying information and
confidential business information as directed above will generally be
made publicly available in redacted form. If a comment has so much
confidential business information or personal identifying information
that it cannot be effectively redacted, all or part of that comment may
not be made publicly available. Comments posted to http://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 direct final rule is available at http://www.regulations.gov under FDMS Docket ID: DEA-2020-0036.
Legal Authority and Background
The Controlled Substances Act (CSA) grants the Attorney General
authority to promulgate rules and regulations relating to the
registration and control of the manufacture, distribution, and
dispensing of controlled substances; maintenance and submission of
records and reports; and for the efficient execution of his statutory
functions.\1\ The CSA further authorizes the Attorney General to
promulgate rules and regulations relating to the registration and
control of importers and exporters of controlled substances.\2\ The
Attorney General has delegated this authority to the Administrator of
DEA.\3\
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\1\ 21 U.S.C. 821, 827, 871(b).
\2\ 21 U.S.C. 958(f).
\3\ 28 CFR 0.100(b).
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The DEA Form 222 is used by DEA registrants to order schedule I and
II controlled substances. In September 2019, DEA issued a final rule to
implement a new single-sheet DEA Form 222 (single-sheet form) to
replace the three-part carbon copy form (triplicate form), and allowed
a transition period for use of existing stocks of the triplicate form
until October 30, 2021 (or earlier if the registrant exhausts its
supply).\4\ Both the single-sheet and triplicate forms require certain
information to be completed
[[Page 38231]]
pertaining to the supplier (i.e., supplier name, address, and DEA
registration number). The final rule set forth a procedure for the
supplier filling DEA Forms 222 and providing its DEA registration
number, among other things, and specifically provides that ``[a]
supplier may fill the order . . . and must record on the original DEA
Form 222 its DEA registration number.'' \5\
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\4\ New Single-Sheet Format for U.S. Official Order Form for
Schedule I and II Controlled Substances (DEA Form 222) 84 FR 51368,
Sept. 30, 2019.
\5\ 21 CFR 1305.13(b).
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As previously noted, both the single-sheet and triplicate forms
require the supplier's DEA registration number to be recorded. On the
triplicate form, the field for the supplier's DEA registration number
is located within a section titled ``TO BE FILLED IN BY SUPPLIER.''
However, on the single-sheet form, the field for the supplier's DEA
registration number is located directly above a section titled ``TO BE
FILLED IN BY PURCHASER.'' This has led to some confusion regarding who
must record the supplier's DEA registration number on the single-sheet
DEA Form 222.
Clarification on Completing the Supplier's DEA Registration Number
Information
Since the publication of the single-sheet final rule, DEA has
received inquiries regarding whether the purchaser or the supplier
should enter the supplier's DEA registration number on the single-sheet
form. DEA is amending its regulations to clarify that either the
purchaser or the supplier may fill in this information. DEA also notes
that the single-sheet form has been slightly modified--and approved by
the Office of Management and Budget (OMB) in July 2020--by the addition
of a line that separates the field for the supplier's DEA registration
number from the field titled, ``PART 2: TO BE FILLED IN BY PURCHASER,''
in which the supplier's business name and address are recorded. This
revised version of the form is being provided to any registrant
requesting paper DEA Forms 222 pursuant to 21 CFR 1305.11.
Regulatory Analyses
Administrative Procedure Act
An agency may find good cause to exempt a rule from prior public
notice provisions of the Administrative Procedure Act (APA) (5 U.S.C.
553(b)(B)), if it is determined to be unnecessary, impracticable, or
contrary to the public interest. This rule clarifies that either the
purchaser or supplier may enter the supplier's DEA registration number
on the single-sheet DEA Form 222. Furthermore, DEA notes that this rule
does not impose any new requirements as the supplier's DEA registration
number is already required to be entered on the single-sheet form.\6\
Therefore, DEA concludes it is unnecessary to issue this rule for
public notice and comment, prior to issuing a final rule, and finds
good cause to exempt this rule from the provisions of the APA under 5
U.S.C. 553(b)(B). For the same reasons, DEA has determined that this
rule is suitable for direct final rulemaking. Although DEA does not
expect to receive significant adverse comment on this rule, DEA has
decided to allow for public comment. If DEA receives significant
adverse comment within 30 days of the publication of this final rule,
it will publish a timely withdrawal of the rule in the Federal
Register.
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\6\ 21 CFR 1305.13(b).
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Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review)
This direct 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. OMB's Office of Information and Regulatory
Affairs (OIRA) has determined that this direct final rule is not a
significant regulatory action as defined by E.O. 12866, section 3(f).
Analysis of Benefits and Costs
DEA has analyzed the economic impact of this direct final rule and
estimates the annual cost to be $0. This rule is minor and technical in
nature, merely clarifying existing DEA regulations and requirements.
Current regulations require the supplier's DEA registration number to
be entered on the single-sheet DEA Form 222. Thus, this rule does not
impose any new requirement and there is no new cost or labor burden
associated with this rule.
While this direct final rule will result in no economic impact on
registrants or DEA, DEA believes there are certain benefits of this
rule. This rule is expected to enhance clarity as well as flexibility,
by clearly stating that either the purchaser or the supplier may enter
the supplier's DEA registration number on the DEA Form 222. While DEA
does not have a basis to quantify the benefits, DEA believes the
benefits are real and welcomed by the affected registrants.
Executive Order 12988, Civil Justice Reform
This direct final rule meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988 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 direct final rule does not have federalism implications
warranting the application of E.O. 13132. The direct final rule does
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This direct final rule does not have tribal implications warranting
the application of E.O. 13175. It 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
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to
rules that are subject to notice and comment under section 553(b) of
the APA or other laws. As explained above, DEA determined that there is
good cause to exempt this direct final rule from notice and comment.
Consequently, the RFA does not apply to this direct final rule.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined that this action would not
result in any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation) in any one year. Therefore, neither a Small Government
Agency Plan nor any other action is required under UMRA of 1995.
[[Page 38232]]
Paperwork Reduction Act of 1995
This direct final rule does not impose a new collection requirement
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). This
direct final rule does not impose new recordkeeping or reporting
requirements on State or local governments, individuals, businesses, or
organizations. Although the direct final rule is applicable to an
existing collection of information, the rule merely clarifies certain
recordkeeping requirements that already apply to registrants using DEA
Form 222 and therefore does not impose any new collection of
information requirement. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.
Congressional Review Act
OIRA has determined that this direct final rule is not a major rule
as defined by Subtitle E of the Small Business Regulatory Enforcement
Fairness Act of 1996 (known as the Congressional Review Act or CRA), 5
U.S.C. 804(2). This direct final rule will not result in an annual
effect on the economy of $100 million or more; a major increase in
costs or prices; or significant adverse effects on competition,
employment, investment, productivity, innovation, or the ability of
United States-based companies to compete with foreign-based companies
in domestic and export markets. However, pursuant to the CRA, DEA is
submitting a copy of this direct final rule to both Houses of Congress
and to the Comptroller General.
List of Subjects
21 CFR Part 1305
Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, DEA amends 21 CFR part 1305 as
follows:
PART 1305--ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
0
1. The authority citation for part 1305 continues to read as follows:
Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.
0
2. In Sec. 1305.12, add a sentence to the end of paragraph (c) to read
as follows:
Sec. 1305.12 Procedure for executing DEA Forms 222.
* * * * *
(c) * * * The supplier's DEA registration number may be entered by
the purchaser or the supplier.
* * * * *
0
3. In Sec. 1305.13, revise the first sentence of paragraph (b) to read
as follows:
Sec. 1305.13 Procedure for filling DEA Forms 222.
* * * * *
(b) A supplier may fill the order, if possible and if the supplier
desires to do so, and must record on the original DEA Form 222 its DEA
registration number (if not previously entered by the purchaser) and
the number of commercial or bulk containers furnished on each item and
the date on which containers are shipped to the purchaser. * * *
* * * * *
Anne Milgram,
Administrator.
[FR Doc. 2021-15323 Filed 7-19-21; 8:45 am]
BILLING CODE 4410-09-P
