[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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