removes regulatory controls and administrative, civil, and criminal
sanctions applicable to controlled substances for handlers and proposed handlers of naloxegol. Accordingly, it has the potential
for some economic impact in the form of cost savings.
Naloxegol is a new molecular entity
and is not currently available or marketed in any country. According to publicly available information reviewed by the DEA, naloxegol
is anticipated to enjoy patent protection for an extended period of time before generic equivalents may be manufactured and marketed
in the United States. Although the number of manufacturers of naloxegol may initially be limited, there is potential for numerous
handlers in various business activities, e.g., distributors, hospitals/clinics, pharmacies, practitioners, etc.
This rule will affect all persons who would
handle, or propose to handle, naloxegol. Due to the wide variety of unidentifiable and unquantifiable variables that potentially
could influence the distribution and dispensing rates of new molecular entities, the DEA is unable to determine the number of entities
and small entities which might handle naloxegol. However, the DEA estimates that all persons who would handle, or propose to handle,
naloxegol are currently registered with the DEA to handle schedule II controlled substances. Therefore, the 1.5 million (1,469,418
as of September 2014) controlled substance registrations, representing approximately 426,714 entities, would be the maximum number
of entities affected by this rule. The DEA estimates that 417,302 (97.8%) of 426,714 affected entities are “small
entities” in accordance with the RFA and Small Business Administration size standards.
The DEA estimates all controlled substances
registrants handle both controlled and non-controlled substances and these registrants are expected to handle naloxegol. Additionally,
since prospective naloxegol handlers are likely to handle other schedule II controlled substances, the cost savings they would
receive as a result of the de-control of naloxegol would be nominal. As naloxegol handlers are likely to handle other schedule
II controlled substances, they will need to maintain their DEA registration and keep the same security, reporting, and recordkeeping
processes, equipment, and facilities in place and would experience only a nominal reduction in security, reporting, inventory,
recordkeeping, and labeling costs.
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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 426,714 of which 417,302
are estimated to be small entities. Since the affected entities are expected to handle other schedule II controlled substances
and maintain security, reporting, and recordkeeping facilities and processes consistent with schedule II controlled substances
handling requirements, the DEA estimates any economic impact (cost savings) will be nominal. Because of these facts, this rule
will not result in a significant economic impact on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
On the basis of information contained in
the “Regulatory Flexibility Act” section above, the DEA has determined and certifies pursuant to the
Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., 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 provisions of UMRA.
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 companies to compete with foreign- based
companies in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy |
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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 to read as follows:
PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES
■ 1.
The authority citation for 21 CFR part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b),
unless otherwise noted.
■ 2.
In § 1308.12, revise the introductory text of paragraph (b)(1) to read as follows:
§ 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, nalmefene,
naloxegol, naloxone, and naltrexone, and their respective salts, but including the following:
* * * * *
Dated: January 16, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015–01172 Filed 1–22–15; 8:45 am]
BILLING CODE 4410–09–P
___________________________________
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 5
[Docket No. USCG–1999–6712]
RIN 1625–AB66
Revision of Auxiliary Regulations
AGENCY: Coast Guard, DHS.
ACTION: Final rule.
___________________________________
SUMMARY: The Coast Guard is amending and reorganizing
the regulations that govern the operation and administration of the Coast Guard Auxiliary, a uniformed, volunteer, non-military
organization chartered by Congress. The amendments conform the regulatory language to changes in the laws governing the Coast Guard
Auxiliary; clarify the Auxiliary’s organization, status, and role in Coast Guard |