82 FR 45436 - Schedules of Controlled Substances: Removal of Naldemedine From Control
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 188 (September 29, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 188 (September 29, 2017)
| Page Range | 45436-45438 | |
| FR Document | 2017-20919 |
[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)] [Rules and Regulations] [Pages 45436-45438] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20919] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-468] Schedules of Controlled Substances: Removal of Naldemedine From Control AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: With the issuance of this final rule, the Drug Enforcement Administration removes the substance naldemedine (4R,4aS,7aR,12bS)-3- (cyclopropylmethyl)-4a,7,9-trihydroxy-N-(2-(3-phenyl-1,2,4-oxadiazol-5- yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro-1H-4,12-methanobenzofuro[3,2- e]isoquinoline-6-carboxamide) including its salts from the schedules of the Controlled Substances Act. Prior to the effective date of this rule, naldemedine was a schedule II controlled substance because it can be derived from opium alkaloids. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle naldemedine. DATES: The effective date of this rule is September 29, 2017. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598- 6812. SUPPLEMENTARY INFORMATION: Legal Authority Pursuant to 21 U.S.C. 811(a)(2), the Attorney General may, by rule, ``remove any drug or other substance from the schedules if he finds that the drug or other substance does not meet the requirements for inclusion in any schedule.'' The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the Drug Enforcement Administration (DEA). 28 CFR 0.100. The Controlled Substances Act (CSA) provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on his own motion, (2) at the request of the Secretary of the Department of Health and Human Services (HHS) \1\, or (3) on the petition of any interested party. 21 U.S.C. 811(a). This action was initiated at the request of the Acting Assistant Secretary for Health of the HHS and by a petition by the drug sponsor to DEA to remove naldemedine from the list of scheduled controlled substances of the CSA, and is supported by, inter alia, a recommendation from the Assistant Secretary of the HHS and an evaluation of all relevant data by the DEA. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle or propose to handle naldemedine. --------------------------------------------------------------------------- \1\ As set forth in a memorandum of understanding entered into by the HHS, the Food and Drug Administration (FDA), and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS in carrying out the Secretary's scheduling responsibilities under the CSA, with the concurrence of the NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993. --------------------------------------------------------------------------- Background Naldemedine, known chemically as (4R,4aS,7aR,12bS)-3- (cyclopropylmethyl)-4a,7,9-trihydroxy-N-(2-(3-phenyl-1,2,4-oxadiazol-5- yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro-1H-4,12-methanobenzofuro[3,2- e]isoquinoline-6-carboxamide, is an opium alkaloid derivative. Naldemedine is a high-affinity antagonist at the mu, kappa, and delta opioid receptors. On March 23, 2016, a new drug application (NDA) was submitted by Shionogi Inc. (Sponsor) to the Food and Drug Administration (FDA) for approval of naldemedine for the treatment of opioid induced constipation in patients with chronic non-cancer pain. The FDA approved naldemedine for marketing on March 23, 2017, under the trade name Symproic[supreg] (0.2 mg tablets).\2\ Naldemedine is indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Opioid-induced constipation is caused by an activation of mu-opioid receptors in the gastrointestinal tract. Naldemedine, a peripheral acting mu-opioid antagonist, can prevent OIC. --------------------------------------------------------------------------- \2\ http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208854Orig1s000ltr.pdf (last accessed 04/13/2017). --------------------------------------------------------------------------- DEA and HHS Eight Factor Analyses On June 8, 2016, the DEA received a petition from the drug sponsor requesting that the DEA amend 21 CFR 1308.12(b)(1) to exclude naldemedine as a schedule II substance from the Controlled Substances Act (CSA). The petitioner stated that naldemedine is a potent peripherally acting mu-opioid receptor antagonist. In accordance with 21 CFR 1308.43(c), the DEA accepted the petition for filing on August 5, 2016. On March 22, 2017, the HHS provided the DEA with a scientific and medical evaluation document prepared by the FDA entitled ``Basis for the Recommendation to Decontrol Naldemedine and its Salts from the Controlled Substances Act.'' After considering the eight factors in 21 U.S.C. 811(c), including consideration of the substance's abuse potential, legitimate medical use, and dependence liability, the Assistant Secretary of the HHS recommended that naldemedine [[Page 45437]] and its salts be removed from schedule II of the CSA. In response, the DEA conducted its own eight factor analysis of naldemedine pursuant to 21 U.S.C. 811(c). Both the DEA and HHS analyses are available in their entirety in the public docket of this rule (Docket Number DEA-468) at http://www.regulations.gov under ``Supporting and Related Material.'' Determination To Decontrol Naldemedine After a review of the available data, including the scientific and medical evaluation and the recommendation to decontrol naldemedine from HHS, the DEA published in the Federal Register a notice of proposed rulemaking (NPRM) entitled ``Schedules of Controlled Substances: Removal of Naldemedine from Control'' which proposed removal of naldemedine including its salts from the schedules of the CSA. 82 FR 32153, July 12, 2017. The proposed rule provided an opportunity for interested persons to file a request for a hearing in accordance with DEA regulations by August 11, 2017. No requests for such a hearing were received by the DEA. The NPRM also provided an opportunity for interested persons to submit written comments on the proposal on or before August 11, 2017. Comments Received The DEA received six comments on the proposed rule to remove naldemedine from control. Five commenters supported the decontrol of naldemedine. One commenter submitted a comment not related to the proposed decontrol action. Support One commenter stated that naldemedine does not induce euphoria therefore limiting its potential for abuse. Another commenter stated that naldemedine can help alleviate constipation which will reduce the amount of time a patient is absent from work or the need for placement on disability. Further, another commenter stated that since naldemedine is a naltrexone derivative, it should be unscheduled. One commenter stated that senators and representatives should support the removal of naldemedine to allow for safe and efficacious use of the drug due to its lack of abuse potential in clinical use. This commenter further suggested that naldemedine be made available to the public without the need for a prescription to treat individuals overdosed on opioids. DEA Response: The DEA appreciates the comments in support of this rulemaking. The comment about making naldemedine available without prescription does not relate to the factors determinative of control of a substance (21 U.S.C. 811(c)) or the criteria for placement of a substance in a particular schedule (21 U.S.C. 812(b)). Unrelated Comment A commenter expressed concerns about reports on ``opioid epidemic'' without consideration of the need for opioids by chronic pain patients. This commenter felt ``patients are being denied, dismissed and overlooked by our drs (sic) due to all the scrutiny associated with treating chronic pain disease.'' DEA Response: Because naldemedine is not an opioid analgesic, this comment about the use of opioid analgesic in the management of pain is unrelated to the current decontrol action. Further it does not relate to the factors determinative of control of a substance (21 U.S.C. 811(c)) or the criteria for placement of a substance in a particular schedule (21 U.S.C. 812(b)). Request for Immediate Effective Date The drug sponsor (Shionogi Inc.) requested that the effective date of this decontrol action correspond to the date of publication of the Final Rule. DEA Response: Generally, DEA scheduling actions are effective 30 days from the date of publication of the final rule in the Federal Register. 21 CFR 1308.45; see also 5 U.S.C. 553(d). In accordance with 21 CFR 1308.45, the DEA finds that the limited availability of effective therapeutic treatments for opioid induced constipation (OIC), coupled with the fact that this is an action for decontrol, supports the finding that conditions of public health require this action to be effective immediately upon publication in the Federal Register. Due to adverse side effects, the majority of treatment alternatives currently available for OIC have restricted clinical application. By comparison, in clinical studies, naldemedine was well tolerated and exhibited a good safety profile in patients with opioid-induced bowel dysfunction. In making the determination to make this rule effective immediately, the DEA took into consideration the effects of immediate implementation. The DEA agrees that making this rule immediately effective is in the best interest of the public health and will not burden registrants, the healthcare system or law enforcement. The DEA notes that its decision to make this rule effective immediately aligns with the exceptions to the 30-day effective date requirement of the Administrative Procedure Act (APA). One of the APA's exceptions to the 30-day effective date is for a substantive rule granting or recognizing an exemption or which relieves a restriction. 5 U.S.C. 553(d)(1). Scheduling Conclusion Based on the consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS, and based on the DEA's consideration of its own eight-factor analysis, the Administrator finds that these facts and all relevant data demonstrate that naldemedine does not meet the requirements for inclusion in any schedule, and will be removed from control under the CSA. Regulatory Analyses Executive Orders 12866 and 15363 In accordance with 21 U.S.C. 811(a), this scheduling action is subject to formal rulemaking procedures performed ``on the record after opportunity for a hearing,'' which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563. Executive Order 12988 This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 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 This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The 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 This rule does not have tribal implications warranting the application of Executive Order 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 [[Page 45438]] power and responsibilities between the Federal Government and Indian tribes. Regulatory Flexibility Act The Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. The purpose of this rule is to remove naldemedine from the list of schedules of the CSA. This action removes regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances for handlers and proposed handlers of naldemedine. Accordingly, it has the potential for some economic impact in the form of cost savings. This rule will affect all persons who handle, or propose to handle, naldemedine. Due to the wide variety of unidentifiable and unquantifiable variables that potentially could influence handling of naldemedine, the DEA is unable to determine the number of entities and small entities which might handle naldemedine. However, the DEA estimates that all persons who handle, or propose to handle naldemedine, are currently registered with the DEA to handle controlled substances. Therefore, the 1.7 million (1,683,023 as of April 2017) controlled substance registrations, representing approximately 436,761 entities, would be the maximum number of entities affected by this rule. The DEA estimates that 425,856 (97.5%) of 436,761 affected entities are ``small entities'' in accordance with the RFA and Small Business Administration size standards. The DEA estimates all controlled substance registrants handle both controlled and non-controlled substances and these registrants are expected to continue to handle naldemedine. Additionally, since prospective naldemedine handlers are likely to handle other controlled substances, the cost benefits they would receive as a result of the de- control of naldemedine is minimal. As naldemedine handlers continue to handle other controlled substances, they will need to maintain their DEA registration and keep the same security and recordkeeping processes, equipment, and facilities in place and would experience only minimal reduction in security, inventory, recordkeeping, and labeling costs. Physical security control requirements are the same for controlled substances listed in schedules II, III, IV, and V for the vast majority of registrants (practitioners). While the DEA does not have a basis to estimate the number of affected entities, the DEA estimates that the maximum number of affected entities is 436,761 of which 425,856 are estimated to be small entities. Since the affected entities are expected to handle other controlled substances and maintain security and recordkeeping facilities and processes consistent with controlled substances, the DEA estimates any economic impact will be minimal. Because of these facts, this rule will not have a significant economic impact on a substantial number of small entities. Unfunded Mandates Reform Act of 1995 In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., the DEA has determined and certifies 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 for inflation) in any one year * * *.'' Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995. Paperwork Reduction Act This action does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. 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 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 (CRA)). This rule will not result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign based enterprises in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, 21 CFR part 1308 is amended as follows: PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES 0 1. The authority citation for 21 CFR part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted. 0 2. In Sec. 1308.12, revise the introductory text of paragraph (b)(1) to read as follows: Sec. 1308.12 Schedule II. * * * * * (b) * * * (1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate excluding apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, naldemedine, nalmefene, naloxegol, naloxone, and naltrexone, and their respective salts, but including the following: * * * * * Dated: September 22, 2017. Chuck Rosenberg, Acting Administrator. [FR Doc. 2017-20919 Filed 9-28-17; 8:45 am] BILLING CODE 4410-09-P
![45436 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations
EDGAR Filer Manual, Volume II: e]isoquinoline-6-carboxamide) of all relevant data by the DEA. This
‘‘EDGAR Filing,’’ Version 43 (September including its salts from the schedules of action removes the regulatory controls
2017). Additional provisions applicable the Controlled Substances Act. Prior to and administrative, civil, and criminal
to Form N–SAR filers are set forth in the the effective date of this rule, sanctions applicable to controlled
EDGAR Filer Manual, Volume III: ‘‘N– naldemedine was a schedule II substances, including those specific to
SAR Supplement,’’ Version 6 (January controlled substance because it can be schedule II controlled substances, on
2017). All of these provisions have been derived from opium alkaloids. This persons who handle or propose to
incorporated by reference into the Code action removes the regulatory controls handle naldemedine.
of Federal Regulations, which action and administrative, civil, and criminal
Background
was approved by the Director of the sanctions applicable to controlled
Federal Register in accordance with 5 substances, including those specific to Naldemedine, known chemically as
U.S.C. 552(a) and 1 CFR part 51. You schedule II controlled substances, on (4R,4aS,7aR,12bS)-3-
must comply with these requirements in persons who handle (manufacture, (cyclopropylmethyl)-4a,7,9-trihydroxy-
order for documents to be timely distribute, reverse distribute, dispense, N-(2-(3-phenyl-1,2,4-oxadiazol-5-
received and accepted. The EDGAR conduct research, import, export, or yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro-
Filer Manual is available for Web site conduct chemical analysis) or propose 1H-4,12-methanobenzofuro[3,2-
viewing and printing; the address for to handle naldemedine. e]isoquinoline-6-carboxamide, is an
the Filer Manual is https://www.sec.gov/ DATES: The effective date of this rule is opium alkaloid derivative. Naldemedine
info/edgar/edmanuals.htm. You can September 29, 2017. is a high-affinity antagonist at the mu,
obtain paper copies of the EDGAR Filer kappa, and delta opioid receptors. On
FOR FURTHER INFORMATION CONTACT:
Manual from the following address: March 23, 2016, a new drug application
Michael J. Lewis, Diversion Control
Public Reference Room, U.S. Securities (NDA) was submitted by Shionogi Inc.
Division, Drug Enforcement
and Exchange Commission, 100 F Street (Sponsor) to the Food and Drug
Administration; Mailing Address: 8701
NE., Washington, DC 20549, on official Administration (FDA) for approval of
Morrissette Drive, Springfield, Virginia
business days between the hours of naldemedine for the treatment of opioid
22152; Telephone: (202) 598–6812.
10:00 a.m. and 3:00 p.m. You can also induced constipation in patients with
SUPPLEMENTARY INFORMATION:
inspect the document at the National chronic non-cancer pain. The FDA
Archives and Records Administration Legal Authority approved naldemedine for marketing on
(NARA). For information on the March 23, 2017, under the trade name
Pursuant to 21 U.S.C. 811(a)(2), the
availability of this material at NARA, Symproic® (0.2 mg tablets).2
Attorney General may, by rule, ‘‘remove
call 202–741–6030, or go to: https:// Naldemedine is indicated for the
any drug or other substance from the
www.archives.gov/federal-register/cfr/ treatment of opioid-induced
schedules if he finds that the drug or
ibr-locations.html. constipation (OIC) in adults with
other substance does not meet the
chronic non-cancer pain. Opioid-
§ 232.301 [Amended] requirements for inclusion in any
induced constipation is caused by an
schedule.’’ The Attorney General has
■ 4. Effective June 1, 2018, amend activation of mu-opioid receptors in the
delegated scheduling authority under 21
§ 232.301 by removing the fourth gastrointestinal tract. Naldemedine, a
U.S.C. 811 to the Administrator of the
sentence. peripheral acting mu-opioid antagonist,
Drug Enforcement Administration
can prevent OIC.
By the Commission. (DEA). 28 CFR 0.100.
Dated: September 13, 2017. The Controlled Substances Act (CSA) DEA and HHS Eight Factor Analyses
Brent J. Fields, provides that proceedings for the On June 8, 2016, the DEA received a
Secretary. issuance, amendment, or repeal of the petition from the drug sponsor
[FR Doc. 2017–20654 Filed 9–28–17; 8:45 am]
scheduling of any drug or other requesting that the DEA amend 21 CFR
substance may be initiated by the 1308.12(b)(1) to exclude naldemedine as
BILLING CODE 8011–01–P
Attorney General (1) on his own motion, a schedule II substance from the
(2) at the request of the Secretary of the Controlled Substances Act (CSA). The
Department of Health and Human petitioner stated that naldemedine is a
DEPARTMENT OF JUSTICE Services (HHS) 1, or (3) on the petition potent peripherally acting mu-opioid
Drug Enforcement Administration of any interested party. 21 U.S.C. 811(a). receptor antagonist. In accordance with
This action was initiated at the request 21 CFR 1308.43(c), the DEA accepted
21 CFR Part 1308 of the Acting Assistant Secretary for the petition for filing on August 5, 2016.
Health of the HHS and by a petition by On March 22, 2017, the HHS provided
[Docket No. DEA–468] the drug sponsor to DEA to remove the DEA with a scientific and medical
naldemedine from the list of scheduled evaluation document prepared by the
Schedules of Controlled Substances: controlled substances of the CSA, and is
Removal of Naldemedine From Control FDA entitled ‘‘Basis for the
supported by, inter alia, a Recommendation to Decontrol
AGENCY: Drug Enforcement recommendation from the Assistant Naldemedine and its Salts from the
Administration, Department of Justice. Secretary of the HHS and an evaluation Controlled Substances Act.’’ After
ACTION: Final rule. considering the eight factors in 21
1 As set forth in a memorandum of understanding
U.S.C. 811(c), including consideration
asabaliauskas on DSKBBXCHB2PROD with RULES
SUMMARY: With the issuance of this final entered into by the HHS, the Food and Drug
Administration (FDA), and the National Institute on of the substance’s abuse potential,
rule, the Drug Enforcement Drug Abuse (NIDA), the FDA acts as the lead agency legitimate medical use, and dependence
Administration removes the substance within the HHS in carrying out the Secretary’s liability, the Assistant Secretary of the
naldemedine (4R,4aS,7aR,12bS)-3- scheduling responsibilities under the CSA, with the
HHS recommended that naldemedine
(cyclopropylmethyl)-4a,7,9-trihydroxy- concurrence of the NIDA. 50 FR 9518, Mar. 8, 1985.
The Secretary of the HHS has delegated to the
N-(2-(3-phenyl-1,2,4-oxadiazol-5- Assistant Secretary for Health of the HHS the 2 http://www.accessdata.fda.gov/drugsatfda_
yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro- authority to make domestic drug scheduling docs/appletter/2017/208854Orig1s000ltr.pdf (last
1H-4,12-methanobenzofuro[3,2- recommendations. 58 FR 35460, July 1, 1993. accessed 04/13/2017).
VerDate Sep<11>2014 16:55 Sep 28, 2017 Jkt 241001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\29SER1.SGM 29SER1](https://thefederalregister.org/doc/82_FR_45624/page/1.svg)
![45438 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations
power and responsibilities between the While the DEA does not have a basis List of Subjects in 21 CFR Part 1308
Federal Government and Indian tribes. to estimate the number of affected Administrative practice and
entities, the DEA estimates that the procedure, Drug traffic control,
Regulatory Flexibility Act
maximum number of affected entities is Reporting and recordkeeping
The Administrator, in accordance 436,761 of which 425,856 are estimated requirements.
with the Regulatory Flexibility Act (5 to be small entities. Since the affected
entities are expected to handle other For the reasons set out above, 21 CFR
U.S.C. 601–612) (RFA), has reviewed
controlled substances and maintain part 1308 is amended as follows:
this rule and by approving it certifies
that it will not have a significant security and recordkeeping facilities PART 1308—SCHEDULES OF
economic impact on a substantial and processes consistent with CONTROLLED SUBSTANCES
number of small entities. The purpose of controlled substances, the DEA
this rule is to remove naldemedine from estimates any economic impact will be ■ 1. The authority citation for 21 CFR
the list of schedules of the CSA. This minimal. Because of these facts, this part 1308 continues to read as follows:
action removes regulatory controls and rule will not have a significant
Authority: 21 U.S.C. 811, 812, 871(b),
administrative, civil, and criminal economic impact on a substantial 956(b), unless otherwise noted.
sanctions applicable to controlled number of small entities.
substances for handlers and proposed ■ 2. In § 1308.12, revise the introductory
Unfunded Mandates Reform Act of 1995 text of paragraph (b)(1) to read as
handlers of naldemedine. Accordingly,
it has the potential for some economic In accordance with the Unfunded follows:
impact in the form of cost savings. Mandates Reform Act (UMRA) of 1995,
§ 1308.12 Schedule II.
2 U.S.C. 1501 et seq., the DEA has
This rule will affect all persons who * * * * *
determined and certifies that this action
handle, or propose to handle, (b) * * *
would not result in any Federal
naldemedine. Due to the wide variety of (1) Opium and opiate, and any salt,
mandate that may result ‘‘in the
unidentifiable and unquantifiable compound, derivative, or preparation of
expenditure by State, local, and tribal
variables that potentially could opium or opiate excluding
governments, in the aggregate, or by the
influence handling of naldemedine, the apomorphine, thebaine-derived
private sector, of $100,000,000 or more
DEA is unable to determine the number butorphanol, dextrorphan, nalbuphine,
(adjusted for inflation) in any one year
of entities and small entities which naldemedine, nalmefene, naloxegol,
* * *.’’ Therefore, neither a Small
might handle naldemedine. However, naloxone, and naltrexone, and their
Government Agency Plan nor any other
the DEA estimates that all persons who respective salts, but including the
action is required under UMRA of 1995.
handle, or propose to handle following:
naldemedine, are currently registered Paperwork Reduction Act * * * * *
with the DEA to handle controlled This action does not impose a new
substances. Therefore, the 1.7 million Dated: September 22, 2017.
collection of information requirement
(1,683,023 as of April 2017) controlled Chuck Rosenberg,
under the Paperwork Reduction Act, 44
substance registrations, representing U.S.C. 3501–3521. This action would Acting Administrator.
approximately 436,761 entities, would not impose recordkeeping or reporting [FR Doc. 2017–20919 Filed 9–28–17; 8:45 am]
be the maximum number of entities requirements on State or local BILLING CODE 4410–09–P
affected by this rule. The DEA estimates governments, individuals, businesses, or
that 425,856 (97.5%) of 436,761 affected organizations. An agency may not
entities are ‘‘small entities’’ in conduct or sponsor, and a person is not DEPARTMENT OF DEFENSE
accordance with the RFA and Small required to respond to, a collection of
Business Administration size standards. information unless it displays a Office of the Secretary
The DEA estimates all controlled currently valid OMB control number.
substance registrants handle both 32 CFR Part 199
controlled and non-controlled Congressional Review Act
[Docket ID: DOD–2017–HA–0039]
substances and these registrants are This rule is not a major rule as
expected to continue to handle defined by section 804 of the Small RIN 0720–AB70
naldemedine. Additionally, since Business Regulatory Enforcement
prospective naldemedine handlers are Fairness Act of 1996 (Congressional Establishment of TRICARE Select and
likely to handle other controlled Review Act (CRA)). This rule will not Other TRICARE Reforms
substances, the cost benefits they would result in: An annual effect on the AGENCY: Office of the Secretary,
receive as a result of the de-control of economy of $100,000,000 or more; a Department of Defense (DoD).
naldemedine is minimal. As major increase in costs or prices for ACTION: Interim final rule.
naldemedine handlers continue to consumers, individual industries,
handle other controlled substances, they Federal, State, or local government SUMMARY: This interim final rule
will need to maintain their DEA agencies, or geographic regions; or implements the primary features of
registration and keep the same security significant adverse effects on section 701 and partially implements
and recordkeeping processes, competition, employment, investment, several other sections of the National
equipment, and facilities in place and productivity, innovation, or on the Defense Authorization Act for Fiscal
asabaliauskas on DSKBBXCHB2PROD with RULES
would experience only minimal ability of United States-based Year 2017 (NDAA–17). The law makes
reduction in security, inventory, enterprises to compete with foreign significant changes to the TRICARE
recordkeeping, and labeling costs. based enterprises in domestic and program, especially to the health
Physical security control requirements export markets. However, pursuant to maintenance organization (HMO)-like
are the same for controlled substances the CRA, the DEA has submitted a copy health plan, known as TRICARE Prime;
listed in schedules II, III, IV, and V for of this final rule to both Houses of to the preferred provider organization
the vast majority of registrants Congress and to the Comptroller (PPO) health plan, previously called
(practitioners). General. TRICARE Extra which is to be replaced
VerDate Sep<11>2014 16:55 Sep 28, 2017 Jkt 241001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\29SER1.SGM 29SER1](https://thefederalregister.org/doc/82_FR_45624/page/3.svg)
Document Created: 2017-09-29 03:26:51
Document Modified: 2017-09-29 03:26:51
| 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 | The effective date of this rule is September 29, 2017. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 82 FR 45436 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR