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Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Rules and Regulations 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
As previously noted, both the singlesheet and triplicate forms require the suppliers DEA registration number to be recorded. On the triplicate form, the field for the suppliers 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 suppliers 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 suppliers DEA registration number on the single-sheet DEA Form 222.
Clarification on Completing the Suppliers DEA Registration Number Information Since the publication of the singlesheet final rule, DEA has received inquiries regarding whether the purchaser or the supplier should enter the suppliers 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 modifiedand approved by the Office of Management and Budget OMB in July 2020by the addition of a line that separates the field for the suppliers DEA registration number from the field titled, PART 2: TO BE
FILLED IN BY PURCHASER, in which the suppliers 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
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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.
553bB, 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 suppliers DEA
registration number on the single-sheet DEA Form 222. Furthermore, DEA notes that this rule does not impose any new 5 21

requirements as the suppliers 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. 553bB. 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.
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.
OMBs 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 3f.
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 suppliers 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 suppliers DEA registration number
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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 3a and 3b2 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. 601612 applies to rules that are subject to notice and comment under section 553b 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.

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