81 FR 3957 - Self-Certification and Employee Training of Mail-Order Distributors of Scheduled Listed Chemical Products
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 15 (January 25, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 15 (January 25, 2016)
| Page Range | 3957-3959 | |
| FR Document | 2016-01377 |
[Federal Register Volume 81, Number 15 (Monday, January 25, 2016)] [Rules and Regulations] [Pages 3957-3959] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01377] [[Page 3957]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1314 [Docket No. DEA-347] RIN 1117-AB30 Self-Certification and Employee Training of Mail-Order Distributors of Scheduled Listed Chemical Products AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This document finalizes the Drug Enforcement Administration's rule implementing the requirements of the Combat Methamphetamine Enhancement Act of 2010 establishing self-certification and training requirements for mail-order distributors of scheduled listed chemical products. This action finalizes without change the interim final rule with request for comment published on April 13, 2011. DATES: This rule takes effect January 25, 2016. FOR FURTHER INFORMATION CONTACT: Barbara J. Boockholdt, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 22512; Telephone: (202) 598-6812. SUPPLEMENTARY INFORMATION: Legal Authority The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the ``Controlled Substances Act'' and the ``Controlled Substances Import and Export Act,'' respectively, but they are collectively referred to as the ``Controlled Substances Act'' or the ``CSA'' for the purposes of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), parts 1300 to 1321. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. The 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 and listed chemicals, 21 U.S.C. 821, and the efficient execution of his statutory functions. 21 U.S.C. 871(b). The Attorney General has delegated this authority to the Administrator of the DEA, 28 CFR 0.100(b), who in turn has redelegated certain authorities to the Deputy Assistant Administrator of the DEA Office of Diversion Control (``Deputy Assistant Administrator''), 28 CFR part 0, appendix to subpart R. By this document, the DEA finalizes the interim final rule, ``Self- Certification and Employee Training of Mail-Order Distributors of Scheduled Listed Chemical Products'' published on April 13, 2011, at 76 FR 20518. This rule became effective on April 13, 2011. The interim final rule solicited public comments for which the comment period closed on June 13, 2011. No comments were received in response to the publication. No changes are being made to the rule. Background The preamble to the interim final rule explained that section 2 of the Combat Methamphetamine Enhancement Act of 2010 (MEA) (Pub. L. 111- 268, 124 Stat. 2847) amended 21 U.S.C. 830(e)(2) to establish new requirements for mail-order distributors to self-certify with the DEA in order to sell scheduled listed chemical products at retail. Sales ``at retail'' are those intended for personal use. 21 U.S.C. 802(48); 21 CFR 1300.02(b). As Congress directed in the MEA, the DEA has established through this rule criteria for certifications of mail-order distributors consistent with the criteria previously established for certifications of other regulated sellers.\1\ The self-certification must include a statement that the mail-order distributor understands the requirements applicable under 21 CFR part 1314 and agrees to comply with those requirements. Prior to certification, mail-order distributors of scheduled listed chemical products are required to provide the DEA-developed training (available at the DEA's Web site) to their employees. --------------------------------------------------------------------------- \1\ The DEA initially established criteria for certifications for regulated sellers pursuant to the Combat Methamphetamine Epidemic Act of 2005 (CMEA), Public Law 109-177, 120 Stat. 256. The DEA implemented the retail sales provisions of the CMEA through Interim Final Rule, ``Retail Sales of Scheduled Listed Chemical Products; Self-Certification of Regulated Sellers of Scheduled Listed Chemical Products,'' published Sept. 26, 2006 at 71 FR 56008; corrected at 71 FR 60609, Oct. 13, 2006. --------------------------------------------------------------------------- The MEA is the most recent in a series of legislative actions aimed at preventing illicit drug manufacturers' access to methamphetamine precursor chemicals and enhancing penalties for methamphetamine production and trafficking. Methamphetamine is a highly addictive stimulant drug in schedule II of the CSA. As recognized through the acts of Congress, the clandestine manufacture and distribution of methamphetamine have been and continue to be serious national public health problems.\2\ --------------------------------------------------------------------------- \2\ E.g., H.R.Rep. No. 109-299, pt. 2 (2005); For a summary of effects of methamphetamine abuse and addiction see NIDA InfoFacts: Methamphetamine (available at http://www.drugabuse.gov/publications/drugfacts/methamphetamine). --------------------------------------------------------------------------- Who are ``mail-order distributors'' subject to the training and self- certification requirements? The MEA refers to ``mail-order distributors'' but does not define the term. As stated in the interim final rule, the idea of mail-order distributor is developed in 21 CFR part 1314, which discusses regulated persons who make a sale at retail of a scheduled listed chemical product and are required under Sec. 1310.03(c) to submit a report of the sales transaction to the Administration. 21 CFR 1314.100(a). The CSA and its implementing regulations impose recordkeeping and reporting requirements on regulated persons who engage in transactions with a nonregulated person or who engage in an export transaction involving ephedrine, pseudoephedrine, phenylpropanolamine, or gamma- hydroxybutyric acid, including drug products containing these chemicals, and who use or attempt to use the Postal Service or any private or commercial carrier. 21 CFR 1310.03(c). Of those subject to the recordkeeping and reporting requirements, only those distributors who engage in mail-order sales at retail of scheduled listed chemical products are subject to the training and self-certification requirements. 21 CFR 1314.101 and 1314.102. A ``mail-order sale,'' for purposes of part 1314, is defined by DEA regulations as a retail sale of scheduled listed chemical products for personal use where a regulated person uses or attempts to use the U.S. Postal Service or any private or commercial carrier to deliver the product to the customer. 21 CFR 1314.03. Mail-order sales include purchase orders submitted by phone, mail, fax, Internet, or any method other than a face-to-face transaction. Id. The terms ``regulated person,'' ``scheduled listed chemical product,'' and ``at retail'' are defined in 21 U.S.C. 802. The DEA is taking this opportunity in publishing this final rule to provide in this supplementary information a clearer discussion of the development of [[Page 3958]] the statutory and regulatory requirements relating to ``mail-order distributors'' than was included in the preamble of the interim final rule. Before 1996 persons now labeled as ``mail-order distributors'' were not subject to specific regulation as a distinct group. Beginning in 1996, Congress has imposed a number of requirements on these distributors, specifically, in such laws as the Comprehensive Methamphetamine Control Act of 1996 (CMCA), Public Law 104-237, 110 Stat. 3099; the Methamphetamine Anti-Proliferation Act of 2000 (MAPA), Public Law 106-310, 114 Stat. 1227; the Combat Methamphetamine Epidemic Act of 2005 (CMEA), Public Law 109-177, 120 Stat. 256; and the MEA. The CMCA established monthly reporting requirements applicable to regulated persons who engage in transactions with nonregulated persons involving ephedrine, pseudoephedrine, or phenylpropanolamine (including drug products containing these chemicals) and use or attempt to use the Postal Service or any private or commercial carrier. 21 U.S.C. 830(b)(3)(B). The DEA implemented the monthly reporting requirement at 21 CFR 1310.03(c). The MAPA amended 21 U.S.C. 830(b)(3)(B) to require regulated persons also to report mail-order export transactions involving ephedrine, pseudoephedrine, and phenylpropanolamine. The MAPA also established exemptions from the mail-order reporting requirements, including an exemption relating to non-``face-to-face'' transactions. 21 U.S.C. 830(b)(3)(D)(ii). That exemption stipulates that retail distributors generally are not required to report non-face- to-face sales of U.S. Food and Drug Administration-approved (FDA- approved) drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine to ultimate users if the seller's activities related to those products are almost exclusively confined to sales for personal use, both in terms of number and volume of sales. Id.; 21 U.S.C. 802(49). Subsequently, the CMEA specified, however, that this clause is not applicable to sales of scheduled listed chemical products at retail. 21 U.S.C. 830(b)(3)(D)(ii). The DEA interprets this to mean that ``retail stores that deliver these products to customers by mail or delivery services will need to comply with the provisions for mail order sales reporting for these transaction[s].'' 71 FR 56008, 56011, Sept. 26, 2006. Certain additional requirements apply to mail-order distributors. For instance, under the CMEA, mail-order distributors making retail sales of scheduled listed chemical products must confirm the purchaser's identity and may not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in scheduled listed chemical products per customer during a 30-day period. 21 U.S.C. 830(e)(2)(A)-(B). Most recently, the MEA added the requirement that mail-order distributors self-certify in order to sell scheduled listed chemical products at retail, and makes it unlawful for any person to negligently fail to self-certify as required under section 830. 21 U.S.C. 830(e)(2)(C) and 842(a)(10). Which locations are subject to the self-certification requirement? Section 2 of the MEA, codified at 21 U.S.C. 830(e)(2)(c), requires the Attorney General to establish by regulation ``criteria for certifications of mail-order distributors that are consistent with the criteria established for the certifications of regulated sellers'' under the CMEA. The CMEA specifies that a separate certification is required for each place of business at which scheduled listed chemical products are sold at retail. 21 U.S.C. 830(e)(1)(B)(ii)(II); 21 CFR 1314.40(c). The DEA analyzed the plain language and purpose of the statute to interpret the meaning of ``each place of business'' where retail sales are made.\3\ As described in the interim final rule, DEA concludes that mail-order distributors are required to certify at: (1) Every location that prepares or packages product for distribution to customers, and (2) every location where employees accept payment for such sales. This interpretation is consistent with the intent of the MEA to ensure that mail-order distributors of scheduled listed chemical products are aware of their recordkeeping, reporting, customer identification, and sales limit requirements. --------------------------------------------------------------------------- \3\ The DEA notes that this statutory language is materially different than the language requiring entities that manufacture, distribute, or dispense controlled substances or list I chemicals to register at ``each principal place of business or professional practice.'' 21 U.S.C. 822(e). The intent and rationale for the two requirements are different, as well. --------------------------------------------------------------------------- Regulatory Analyses Executive Order 12866 (Regulatory Planning and Review) This regulation has been drafted and reviewed in accordance with Executive Order 12866, ``Regulatory Planning and Review,'' section 1(b), Principles of Regulation. It has been determined that this is not ``a significant regulatory action.'' As discussed above, and in the interim final rule, this action is codifying statutory provisions and involves no agency discretion as to regulatory alternatives. As analyzed in the interim final rule at 76 FR 20158, the DEA has determined that the MEA's requirements will not impose an annual cost on the economy of $100 million or more, the standard for an economically significant rule under Executive Order 12866. The DEA received no public comments with respect to the interim final rule. Paperwork Reduction Act of 1995 To address the new mandates of the MEA, the DEA has revised its existing information collection ``Self-Certification, Training and Logbooks for Regulated Sellers and Mail-Order Distributors of Scheduled Listed Chemical Products,'' Information Collection 1117-0046. The MEA requires mail-order distributors to train any employee who will be involved in selling scheduled listed chemical products and to document the training. Mail-order distributors must also self-certify to the DEA that all affected employees have been trained and that the mail-order distributor is in compliance with all provisions of the CMEA. No comments were received by the DEA regarding the information collection. Regulatory Flexibility Analysis The Deputy Assistant Administrator, in accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. As noted in the interim final rule, the RFA applies to rules that are subject to notice and comment. The DEA determined, as explained in the interim final rule, that public notice and comment were impracticable and contrary to the public interest. Consequently, the RFA does not apply. Although the RFA does not apply to this rulemaking, the DEA has reviewed the potential impacts in the interim final rule, in which the DEA certified that the rule will not have a significant economic impact on small entities. As published in the interim final rule, based on reports filed, DEA expects that the rule will affect only 9 firms, two of which are not small based on the Small Business Administration's size standards. For the seven small firms, the only costs are the $21 annual fee, the time required to complete the certification (0.5 hours or about $20 for a new self-certification application), and [[Page 3959]] cost of training (0.5 hours or about $10). The cost of compliance for these firms, which appear to have between 5 and 25 employees, not all of whom would need to be trained, is less than $200 and in most cases, less than $100. The smallest mail order pharmacies (those with fewer than five employees) have average annual sales of $1 million. The cost of compliance is, therefore, less than 0.1 percent of sales and would not impose a significant economic burden on any small entity. The DEA received no public comments with respect to the interim final rule and the DEA has not received any other information that would materially change the impact of this rule on small entities. Therefore, the DEA concludes this rulemaking will not have a significant economic impact on a substantial number of small entities. Unfunded Mandates Reform Act of 1995 This rule will not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 109 Stat. 48). This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. E.O. 12988 (Civil Justice Reform) This regulation meets the applicable standards set forth in section 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. Executive Order 13132 (Federalism) This rulemaking has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, and the DEA has determined that this action does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. This rulemaking does not impose enforcement responsibilities on any State; nor does it diminish the power of any State to enforce its own laws. The requirements of this rule are mandated under the MEA, and the DEA has no authority to alter them or change the preemption. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132. Executive Order 13175 (Tribal Consultation) The DEA has analyzed this action under Executive Order 13175 and this rule will not have substantial direct effects on one or more Indian tribes; will not impose substantial direct compliance costs on Indian tribal governments; and will not preempt tribal law. Therefore, a tribal summary impact statement is not required. Congressional Review Act This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100 million or more. It will not cause a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the United States-based companies to compete with foreign-based companies in domestic and export markets. List of Subjects in 21 CFR Part 1314 Drug traffic control, Reporting and recordkeeping requirements. Accordingly, the interim final rule amending 21 CFR part 1314 which was published at 76 FR 20518 on April 13, 2011, is adopted as a final rule without change. Dated: January 19, 2016. Louis J. Milione, Deputy Assistant Administrator, Office of Diversion Control. [FR Doc. 2016-01377 Filed 1-22-16; 8:45 am] BILLING CODE 4410-09-P
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DEPARTMENT OF JUSTICE chemicals, 21 U.S.C. 821, and the methamphetamine production and
efficient execution of his statutory trafficking. Methamphetamine is a
Drug Enforcement Administration functions. 21 U.S.C. 871(b). The highly addictive stimulant drug in
Attorney General has delegated this schedule II of the CSA. As recognized
21 CFR Part 1314 authority to the Administrator of the through the acts of Congress, the
[Docket No. DEA–347] DEA, 28 CFR 0.100(b), who in turn has clandestine manufacture and
redelegated certain authorities to the distribution of methamphetamine have
RIN 1117–AB30 Deputy Assistant Administrator of the been and continue to be serious national
DEA Office of Diversion Control public health problems.2
Self-Certification and Employee (‘‘Deputy Assistant Administrator’’), 28
Training of Mail-Order Distributors of Who are ‘‘mail-order distributors’’
CFR part 0, appendix to subpart R.
Scheduled Listed Chemical Products By this document, the DEA finalizes subject to the training and self-
the interim final rule, ‘‘Self-Certification certification requirements?
AGENCY: Drug Enforcement
Administration, Department of Justice. and Employee Training of Mail-Order The MEA refers to ‘‘mail-order
Distributors of Scheduled Listed distributors’’ but does not define the
ACTION: Final rule.
Chemical Products’’ published on April term. As stated in the interim final rule,
SUMMARY: This document finalizes the 13, 2011, at 76 FR 20518. This rule the idea of mail-order distributor is
Drug Enforcement Administration’s rule became effective on April 13, 2011. The developed in 21 CFR part 1314, which
implementing the requirements of the interim final rule solicited public discusses regulated persons who make a
Combat Methamphetamine comments for which the comment sale at retail of a scheduled listed
Enhancement Act of 2010 establishing period closed on June 13, 2011. No chemical product and are required
self-certification and training comments were received in response to under § 1310.03(c) to submit a report of
requirements for mail-order distributors the publication. No changes are being the sales transaction to the
of scheduled listed chemical products. made to the rule. Administration. 21 CFR 1314.100(a).
This action finalizes without change the The CSA and its implementing
Background regulations impose recordkeeping and
interim final rule with request for
The preamble to the interim final rule reporting requirements on regulated
comment published on April 13, 2011.
explained that section 2 of the Combat persons who engage in transactions with
DATES: This rule takes effect January 25,
Methamphetamine Enhancement Act of a nonregulated person or who engage in
2016. 2010 (MEA) (Pub. L. 111–268, 124 Stat. an export transaction involving
FOR FURTHER INFORMATION CONTACT: 2847) amended 21 U.S.C. 830(e)(2) to ephedrine, pseudoephedrine,
Barbara J. Boockholdt, Office of establish new requirements for mail- phenylpropanolamine, or gamma-
Diversion Control, Drug Enforcement order distributors to self-certify with the hydroxybutyric acid, including drug
Administration, 8701 Morrissette Drive, DEA in order to sell scheduled listed products containing these chemicals,
Springfield, Virginia 22512; Telephone: chemical products at retail. Sales ‘‘at and who use or attempt to use the Postal
(202) 598–6812. retail’’ are those intended for personal Service or any private or commercial
SUPPLEMENTARY INFORMATION: use. 21 U.S.C. 802(48); 21 CFR carrier. 21 CFR 1310.03(c). Of those
1300.02(b). As Congress directed in the subject to the recordkeeping and
Legal Authority
MEA, the DEA has established through reporting requirements, only those
The Drug Enforcement this rule criteria for certifications of distributors who engage in mail-order
Administration (DEA) implements and mail-order distributors consistent with sales at retail of scheduled listed
enforces titles II and III of the the criteria previously established for chemical products are subject to the
Comprehensive Drug Abuse Prevention certifications of other regulated sellers.1 training and self-certification
and Control Act of 1970, as amended. 21 The self-certification must include a requirements. 21 CFR 1314.101 and
U.S.C. 801–971. Titles II and III are statement that the mail-order distributor 1314.102. A ‘‘mail-order sale,’’ for
referred to as the ‘‘Controlled understands the requirements purposes of part 1314, is defined by
Substances Act’’ and the ‘‘Controlled applicable under 21 CFR part 1314 and DEA regulations as a retail sale of
Substances Import and Export Act,’’ agrees to comply with those scheduled listed chemical products for
respectively, but they are collectively requirements. Prior to certification, personal use where a regulated person
referred to as the ‘‘Controlled mail-order distributors of scheduled uses or attempts to use the U.S. Postal
Substances Act’’ or the ‘‘CSA’’ for the listed chemical products are required to Service or any private or commercial
purposes of this action. The DEA provide the DEA-developed training carrier to deliver the product to the
publishes the implementing regulations (available at the DEA’s Web site) to their customer. 21 CFR 1314.03. Mail-order
for these statutes in title 21 of the Code employees. sales include purchase orders submitted
of Federal Regulations (CFR), parts 1300 The MEA is the most recent in a series by phone, mail, fax, Internet, or any
to 1321. The CSA and its implementing of legislative actions aimed at method other than a face-to-face
regulations are designed to prevent, preventing illicit drug manufacturers’ transaction. Id. The terms ‘‘regulated
detect, and eliminate the diversion of access to methamphetamine precursor person,’’ ‘‘scheduled listed chemical
controlled substances and listed chemicals and enhancing penalties for product,’’ and ‘‘at retail’’ are defined in
chemicals into the illicit market while 21 U.S.C. 802.
providing for the legitimate medical, 1 The DEA initially established criteria for The DEA is taking this opportunity in
scientific, research, and industrial needs certifications for regulated sellers pursuant to the publishing this final rule to provide in
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Combat Methamphetamine Epidemic Act of 2005 this supplementary information a
of the United States. (CMEA), Public Law 109–177, 120 Stat. 256. The
The CSA grants the Attorney General DEA implemented the retail sales provisions of the clearer discussion of the development of
authority to promulgate rules and CMEA through Interim Final Rule, ‘‘Retail Sales of
regulations relating to the registration Scheduled Listed Chemical Products; Self- 2 E.g., H.R.Rep. No. 109–299, pt. 2 (2005); For a
Certification of Regulated Sellers of Scheduled summary of effects of methamphetamine abuse and
and control of the manufacture, Listed Chemical Products,’’ published Sept. 26, addiction see NIDA InfoFacts: Methamphetamine
distribution, and dispensing of 2006 at 71 FR 56008; corrected at 71 FR 60609, Oct. (available at http://www.drugabuse.gov/
controlled substances and listed 13, 2006. publications/drugfacts/methamphetamine).
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the statutory and regulatory under the CMEA, mail-order interim final rule, this action is
requirements relating to ‘‘mail-order distributors making retail sales of codifying statutory provisions and
distributors’’ than was included in the scheduled listed chemical products involves no agency discretion as to
preamble of the interim final rule. must confirm the purchaser’s identity regulatory alternatives. As analyzed in
Before 1996 persons now labeled as and may not sell more than 7.5 grams the interim final rule at 76 FR 20158,
‘‘mail-order distributors’’ were not of ephedrine base, pseudoephedrine the DEA has determined that the MEA’s
subject to specific regulation as a base, or phenylpropanolamine base in requirements will not impose an annual
distinct group. Beginning in 1996, scheduled listed chemical products per cost on the economy of $100 million or
Congress has imposed a number of customer during a 30-day period. 21 more, the standard for an economically
requirements on these distributors, U.S.C. 830(e)(2)(A)–(B). Most recently, significant rule under Executive Order
specifically, in such laws as the the MEA added the requirement that 12866. The DEA received no public
Comprehensive Methamphetamine mail-order distributors self-certify in comments with respect to the interim
Control Act of 1996 (CMCA), Public order to sell scheduled listed chemical final rule.
Law 104–237, 110 Stat. 3099; the products at retail, and makes it unlawful
Paperwork Reduction Act of 1995
Methamphetamine Anti-Proliferation for any person to negligently fail to self-
Act of 2000 (MAPA), Public Law 106– certify as required under section 830. 21 To address the new mandates of the
310, 114 Stat. 1227; the Combat U.S.C. 830(e)(2)(C) and 842(a)(10). MEA, the DEA has revised its existing
Methamphetamine Epidemic Act of information collection ‘‘Self-
Which locations are subject to the self- Certification, Training and Logbooks for
2005 (CMEA), Public Law 109–177, 120
certification requirement? Regulated Sellers and Mail-Order
Stat. 256; and the MEA.
The CMCA established monthly Section 2 of the MEA, codified at 21 Distributors of Scheduled Listed
reporting requirements applicable to U.S.C. 830(e)(2)(c), requires the Chemical Products,’’ Information
regulated persons who engage in Attorney General to establish by Collection 1117–0046. The MEA
transactions with nonregulated persons regulation ‘‘criteria for certifications of requires mail-order distributors to train
involving ephedrine, pseudoephedrine, mail-order distributors that are any employee who will be involved in
or phenylpropanolamine (including consistent with the criteria established selling scheduled listed chemical
drug products containing these for the certifications of regulated products and to document the training.
chemicals) and use or attempt to use the sellers’’ under the CMEA. The CMEA Mail-order distributors must also self-
Postal Service or any private or specifies that a separate certification is certify to the DEA that all affected
commercial carrier. 21 U.S.C. required for each place of business at employees have been trained and that
830(b)(3)(B). The DEA implemented the which scheduled listed chemical the mail-order distributor is in
monthly reporting requirement at 21 products are sold at retail. 21 U.S.C. compliance with all provisions of the
CFR 1310.03(c). The MAPA amended 21 830(e)(1)(B)(ii)(II); 21 CFR 1314.40(c). CMEA. No comments were received by
U.S.C. 830(b)(3)(B) to require regulated The DEA analyzed the plain language the DEA regarding the information
persons also to report mail-order export and purpose of the statute to interpret collection.
transactions involving ephedrine, the meaning of ‘‘each place of business’’
Regulatory Flexibility Analysis
pseudoephedrine, and where retail sales are made.3 As
phenylpropanolamine. described in the interim final rule, DEA The Deputy Assistant Administrator,
The MAPA also established concludes that mail-order distributors in accordance with the Regulatory
exemptions from the mail-order are required to certify at: (1) Every Flexibility Act (RFA) (5 U.S.C. 601–
reporting requirements, including an location that prepares or packages 612), has reviewed this regulation and
exemption relating to non-‘‘face-to-face’’ product for distribution to customers, by approving it certifies that this
transactions. 21 U.S.C. 830(b)(3)(D)(ii). and (2) every location where employees regulation will not have a significant
That exemption stipulates that retail accept payment for such sales. This economic impact on a substantial
distributors generally are not required to interpretation is consistent with the number of small entities. As noted in
report non-face-to-face sales of U.S. intent of the MEA to ensure that mail- the interim final rule, the RFA applies
Food and Drug Administration- order distributors of scheduled listed to rules that are subject to notice and
approved (FDA-approved) drug chemical products are aware of their comment. The DEA determined, as
products containing ephedrine, recordkeeping, reporting, customer explained in the interim final rule, that
pseudoephedrine, or identification, and sales limit public notice and comment were
phenylpropanolamine to ultimate users requirements. impracticable and contrary to the public
if the seller’s activities related to those interest. Consequently, the RFA does
Regulatory Analyses
products are almost exclusively not apply.
confined to sales for personal use, both Executive Order 12866 (Regulatory Although the RFA does not apply to
in terms of number and volume of sales. Planning and Review) this rulemaking, the DEA has reviewed
Id.; 21 U.S.C. 802(49). Subsequently, the This regulation has been drafted and the potential impacts in the interim
CMEA specified, however, that this reviewed in accordance with Executive final rule, in which the DEA certified
clause is not applicable to sales of Order 12866, ‘‘Regulatory Planning and that the rule will not have a significant
scheduled listed chemical products at Review,’’ section 1(b), Principles of economic impact on small entities. As
retail. 21 U.S.C. 830(b)(3)(D)(ii). The Regulation. It has been determined that published in the interim final rule,
DEA interprets this to mean that ‘‘retail this is not ‘‘a significant regulatory based on reports filed, DEA expects that
stores that deliver these products to action.’’ As discussed above, and in the the rule will affect only 9 firms, two of
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customers by mail or delivery services which are not small based on the Small
will need to comply with the provisions 3 The DEA notes that this statutory language is Business Administration’s size
for mail order sales reporting for these materially different than the language requiring standards. For the seven small firms, the
transaction[s].’’ 71 FR 56008, 56011, entities that manufacture, distribute, or dispense only costs are the $21 annual fee, the
controlled substances or list I chemicals to register
Sept. 26, 2006. at ‘‘each principal place of business or professional
time required to complete the
Certain additional requirements apply practice.’’ 21 U.S.C. 822(e). The intent and rationale certification (0.5 hours or about $20 for
to mail-order distributors. For instance, for the two requirements are different, as well. a new self-certification application), and
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cost of training (0.5 hours or about $10). effects on one or more Indian tribes; will services, within available resources, at
The cost of compliance for these firms, not impose substantial direct locations outside the United States to
which appear to have between 5 and 25 compliance costs on Indian tribal support DoD personnel and their
employees, not all of whom would need governments; and will not preempt families.
to be trained, is less than $200 and in tribal law. Therefore, a tribal summary DATES: This rule is effective February
most cases, less than $100. The smallest impact statement is not required. 24, 2016.
mail order pharmacies (those with fewer
Congressional Review Act FOR FURTHER INFORMATION CONTACT: Mr.
than five employees) have average
annual sales of $1 million. The cost of This rule is not a major rule as Chris Wright, 703–588–0172.
compliance is, therefore, less than 0.1 defined by section 804 of the Small SUPPLEMENTARY INFORMATION: The
percent of sales and would not impose Business Regulatory Enforcement Department of Defense published a
a significant economic burden on any Fairness Act of 1996 (Congressional proposed rule on November 24, 2014
small entity. Review Act). This rule will not result in (79 FR 69777–69781), with a request for
The DEA received no public an annual effect on the economy of $100 public comments. The 60-day public
comments with respect to the interim million or more. It will not cause a comment period ended on January 23,
final rule and the DEA has not received major increase in costs or prices; or 2015. One public comment was
any other information that would significant adverse effects on received. This comment is addressed as
materially change the impact of this rule competition, employment, investment, follows:
on small entities. Therefore, the DEA productivity, innovation, or on the Comment: It is my opinion that this
concludes this rulemaking will not have ability of the United States-based unchecked support of the scouting
a significant economic impact on a companies to compete with foreign- organizations violates the Establishment
substantial number of small entities. based companies in domestic and Clause of Amendment I to the United
export markets. States Constitution. The Boy Scouts
Unfunded Mandates Reform Act of 1995 have acted as a religious organization by
This rule will not impose unfunded List of Subjects in 21 CFR Part 1314
using religion as a reason to exclude gay
mandates as defined by the Unfunded Drug traffic control, Reporting and scout leaders. Providing facilities and
Mandates Reform Act of 1995 (Pub. L. recordkeeping requirements. equipment free of charge effectively
104–4, 109 Stat. 48). This rule will not Accordingly, the interim final rule supports this effort and therefore
result in the expenditure by State, local amending 21 CFR part 1314 which was violates the Establishment Clause. I
and tribal governments, in the aggregate, published at 76 FR 20518 on April 13, wholeheartedly do not support this rule
or by the private sector, of $100 million 2011, is adopted as a final rule without change.
or more in any one year, and it will not change. Response: During litigation, the
significantly or uniquely affect small Dated: January 19, 2016. Department of Defense (DoD), along
governments. Therefore no actions were Louis J. Milione, with the Department of Justice, has
deemed necessary under the provisions consistently defended the legality of the
Deputy Assistant Administrator, Office of
of the Unfunded Mandates Reform Act Diversion Control. statutorily authorized support to the
of 1995. Boy Scouts of America (BSA) and other
[FR Doc. 2016–01377 Filed 1–22–16; 8:45 am]
E.O. 12988 (Civil Justice Reform) organizations. In briefs, the Government
BILLING CODE 4410–09–P
has argued that: (1) The BSA is a civic
This regulation meets the applicable organization, which focuses on
standards set forth in section 3(a) and citizenship training, community service
3(b)(2) of Executive Order 12988 Civil DEPARTMENT OF DEFENSE and outdoor activities and physical
Justice Reform. fitness; (2) DoD support to the BSA has
Office of the Secretary
Executive Order 13132 (Federalism) advanced several compelling military
32 CFR Part 252 purposes; and (3) DoD support to the
This rulemaking has been analyzed in BSA does not result in Government
accordance with the principles and [Docket ID: DOD–2012–OS–0170] indoctrination or endorsement of
criteria contained in Executive Order religion.
13132, and the DEA has determined that RIN 0790–AI98
this action does not have sufficient Executive Summary
Professional U.S. Scouting
federalism implications to warrant the I. Purpose of the Regulatory Action
Organization Operations at U.S.
preparation of a federalism summary
Military Installations Overseas This rule provides that support
impact statement. This rulemaking does
not impose enforcement responsibilities AGENCY: Under Secretary of Defense for provided by DoD is documented in
on any State; nor does it diminish the Personnel and Readiness, DoD. written agreements and signed by the
power of any State to enforce its own ACTION: Final rule. appropriate regional combatant
laws. The requirements of this rule are commander. Also, it would require
mandated under the MEA, and the DEA SUMMARY: This rule updates policy and installation-specific support and
has no authority to alter them or change outlines fiscal and logistical support the services to be based on a written
the preemption. Accordingly, this DoD may provide to qualified scouting agreement and signed by the installation
rulemaking does not have federalism organizations operating on U.S. military commander or designee. These
implications warranting the application installations overseas based on agreements will replace the need for
mstockstill on DSK4VPTVN1PROD with RULES
of Executive Order 13132. Executive Order 12715, Support of these organizations to submit individual
Overseas Scouting Activities for articles of incorporation, written
Executive Order 13175 (Tribal Military Dependents, and pertinent constitutions, charters, or articles of
Consultation) statutes as discussed below. It is DoD agreement to gain approval from the
The DEA has analyzed this action policy to cooperate with and assist installation commander to operate on
under Executive Order 13175 and this qualified scouting organizations in the installation. In addition to Executive
rule will not have substantial direct establishing and providing facilities and Order 12715, Title 10 of the United
VerDate Sep<11>2014 13:57 Jan 22, 2016 Jkt 238001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\25JAR1.SGM 25JAR1](https://thefederalregister.org/doc/81_FR_3972/page/3.svg)
Document Created: 2018-02-02 12:35:11
Document Modified: 2018-02-02 12:35:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule takes effect January 25, 2016. | |
| Contact | Barbara J. Boockholdt, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 22512; Telephone: (202) 598-6812. | |
| FR Citation | 81 FR 3957 | |
| RIN Number | 1117-AB30 | |
| CFR Associated | Drug Traffic Control and Reporting and Recordkeeping Requirements |
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