[Federal Register Volume 82, Number 18 (Monday, January 30, 2017)]
[Rules and Regulations]
[Pages 8688-8689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01976]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312,
1313, 1314, 1315, 1316, and 1321
[Docket No. DEA-403]
RIN 1117-AB41
Revision of Import and Export Requirements for Controlled
Substances, Listed Chemicals, and Tableting and Encapsulating Machines,
Including Changes To Implement the International Trade Data System
(ITDS); Revision of Reporting Requirements for Domestic Transactions in
Listed Chemicals and Tableting and Encapsulating Machines; and
Technical Amendments
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule; delay of effective date.
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SUMMARY: On December 30, 2016, the Drug Enforcement Administration
published a final rule to implement requirements associated with the
International Trade Data System (ITDS) that will help streamline the
export/import of tableting and encapsulating machines, controlled
substances, and listed chemicals. That rule is scheduled to become
effective January 30, 2017. In accordance with the memorandum of
January 20, 2017, from the Assistant to the President and Chief of
Staff, entitled ``Regulatory Freeze Pending Review,'' this action
hereby temporarily delays until March 21, 2017, the effective date of
the final rule entitled ``Revision of Import and Export Requirements
for Controlled Substances, Listed Chemicals, and Tableting and
Encapsulating Machines, Including Changes to Implement the
International Trade Data System (ITDS); Revision of Reporting
Requirements for Domestic Transactions in Listed Chemicals and
Tableting and Encapsulating Machines; and Technical Amendments'' (RIN
1117-AB41) published in the Federal Register on December 30, 2016, at
81 FR 96992. The temporary delay in the effective date will allow
Department of Justice officials an opportunity to review any potential
questions of fact, law and policy raised by this regulation, consistent
with the Chief of Staff's memorandum of January 20, 2017.
DATES: Effective Dates: This Final Rule is effective January 30, 2017.
The effective date of the Final Rule amending 21 CFR parts 1300, 1301,
1302, 1303, 1304, 1308, 1309, 1310, 1312, 1313, 1314, 1315, 1316, and
1321 published in the Federal Register December 30, 2016, at 81 FR
96992 is delayed to March 21, 2017. However, compliance with the
revisions to DEA regulations made by this rule is not required until
July 31, 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: The Drug Enforcement Administration (DEA) is
updating its regulations for the import and export of tableting and
encapsulating machines, controlled substances, and listed chemicals,
and its regulations relating to reports required for domestic
transactions in listed chemicals, gamma-hydroxybutyric acid, and
tableting and encapsulating machines. In accordance with Executive
Order 13563, the DEA has reviewed its import and export regulations and
reporting requirements for domestic transactions in listed chemicals
(and gamma-hydroxybutyric acid) and tableting and encapsulating
machines, and evaluated them for clarity, consistency, continued
accuracy, and effectiveness. The amendments clarify certain policies
and reflect current procedures and technological advancements. The
amendments also allow for the implementation, as applicable to
tableting and encapsulating machines, controlled substances, and listed
chemicals, of the President's Executive Order 13659 on streamlining the
export/import process and requiring the government-wide utilization of
the International Trade Data System (ITDS). This rule additionally
contains amendments that implement recent changes to the Controlled
Substances Import and Export Act for reexportation of controlled
substances among members of the European Economic Area made by the
Improving Regulatory Transparency for New Medical Therapies Act. The
rule also includes additional substantive and technical and stylistic
amendments.
On July 15, 2016, the DEA published a general notice in the Federal
Register announcing, in coordination with U.S. Customs and Border
Protection (CBP), a pilot test of the ITDS involving the electronic
submission of data related to the importation and exportation of
controlled substances and listed chemicals. (81 FR 46058). The pilot
program is testing the electronic transmission through CBP's ACE
system, of data, forms and documents required by the DEA using the
Partner Government Agency (PGA) Message Set and the Document Image
System (DIS). The data, forms, and documents are transmitted for review
by the DEA. The PGA Message Set and DIS enable importers, exporters,
and brokers to electronically transmit data required by the DEA
directly through ACE; this electronic process replaces certain paper-
based processes that are used outside of the pilot program. The test
commenced on August 1, 2016, and will continue until publication of a
notice in the Federal Register. Any party seeking to participate in the
test was instructed to contact their CBP client representative. The
pilot program will be concluded as of the effective date of the final
rule. At that time, all importers, exporters, and brokers will be able
to use ACE to electronically file required data and documentation
associated with the importation and exportation of controlled
substances and listed chemicals.
The DEA's implementation of this action without opportunity for
public comment is based on the good cause exceptions in 5 U.S.C.
553(b)(B) because seeking public comment is impracticable, unnecessary
and contrary to the public interest. The temporary delay in the
effective date will allow Department of Justice officials an
opportunity to review any potential questions of fact, law and policy
raised by this regulation, consistent with the Chief of Staff's
memorandum of January 20, 2017. Given the imminence of the rule's
effective date, seeking prior public comment on this temporary delay
would have been impractical, as well as contrary to the public interest
in the orderly promulgation and implementation of regulations. For the
foregoing reasons, the good cause exceptions in 5 U.S.C. 553(d)(3) also
apply to DEA's decision to make today's action effective immediately.
[[Page 8689]]
In accordance with the memorandum of January 20, 2017, from the
Assistant to the President and Chief of Staff, entitled ``Regulatory
Freeze Pending Review'' this action hereby temporarily delays until
March 21, 2017, the effective date of the final rule entitled
``Revision of Import and Export Requirements for Controlled Substances,
Listed Chemicals, and Tableting and Encapsulating Machines, Including
Changes to Implement the International Trade Data System (ITDS);
Revision of Reporting Requirements for Domestic Transactions in Listed
Chemicals and Tableting and Encapsulating Machines; and Technical
Amendments'' (RIN 1117-AB41) published in the Federal Register on
December 30, 2016, at 81 FR 96992.
Dated: January 25, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-01976 Filed 1-27-17; 8:45 am]
BILLING CODE 4410-09-P