Clarification Regarding the Supplier's DEA Registration Number on the Single-Sheet DEA Form 222

CourtDrug Enforcement Administration
Citation86 FR 38230
Record Number2021-15323
Publication Date20 Jul 2021
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]
                =======================================================================
                -----------------------------------------------------------------------
                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.
                -----------------------------------------------------------------------
                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\
                ---------------------------------------------------------------------------
                 \1\ 21 U.S.C. 821, 827, 871(b).
                 \2\ 21 U.S.C. 958(f).
                 \3\ 28 CFR 0.100(b).
                ---------------------------------------------------------------------------
                 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\
                ---------------------------------------------------------------------------
                 \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).
                ---------------------------------------------------------------------------
                 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.
                ---------------------------------------------------------------------------
                 \6\ 21 CFR 1305.13(b).
                ---------------------------------------------------------------------------
                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
                

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT