82 FR 8688 - 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

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 18 (January 30, 2017)

Page Range		8688-8689
FR Document		2017-01976

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.

Federal Register, Volume 82 Issue 18 (Monday, January 30, 2017)

[Federal Register Volume 82, Number 18 (Monday, January 30, 2017)]
[Rules and Regulations]
[Pages 8688-8689]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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

8688 Federal Register / Vol. 82, No. 18 / Monday, January 30, 2017 / Rules and Regulations

(b) In addition to complying with Reporting Requirements for Domestic of the European Economic Area made
section 5.7.2 of ASTM F2907–15, Transactions in Listed Chemicals and by the Improving Regulatory
comply with the following: Tableting and Encapsulating Machines; Transparency for New Medical
(1) 5.7.3 Warning labels that are and Technical Amendments’’ (RIN Therapies Act. The rule also includes
attached to the fabric with seams shall 1117–AB41) published in the Federal additional substantive and technical
remain in contact with the fabric around Register on December 30, 2016, at 81 FR and stylistic amendments.
the entire perimeter of the label, when 96992. The temporary delay in the On July 15, 2016, the DEA published
the sling is in all manufacturer effective date will allow Department of a general notice in the Federal Register
recommended use positions. Justice officials an opportunity to announcing, in coordination with U.S.
(2) [Reserved] review any potential questions of fact, Customs and Border Protection (CBP), a
law and policy raised by this regulation, pilot test of the ITDS involving the
Todd A. Stevenson, consistent with the Chief of Staff’s electronic submission of data related to
Secretary, Consumer Product Safety memorandum of January 20, 2017.
Commission.
the importation and exportation of
DATES: Effective Dates: This Final Rule controlled substances and listed
[FR Doc. 2017–01285 Filed 1–27–17; 8:45 am]
is effective January 30, 2017. The chemicals. (81 FR 46058). The pilot
BILLING CODE 6355–01–P effective date of the Final Rule program is testing the electronic
amending 21 CFR parts 1300, 1301, transmission through CBP’s ACE
1302, 1303, 1304, 1308, 1309, 1310, system, of data, forms and documents
DEPARTMENT OF JUSTICE 1312, 1313, 1314, 1315, 1316, and 1321 required by the DEA using the Partner
published in the Federal Register Government Agency (PGA) Message Set
Drug Enforcement Administration December 30, 2016, at 81 FR 96992 is and the Document Image System (DIS).
delayed to March 21, 2017. However, The data, forms, and documents are
21 CFR Parts 1300, 1301, 1302, 1303, compliance with the revisions to DEA transmitted for review by the DEA. The
1304, 1308, 1309, 1310, 1312, 1313, regulations made by this rule is not PGA Message Set and DIS enable
1314, 1315, 1316, and 1321 required until July 31, 2017. importers, exporters, and brokers to
[Docket No. DEA–403] FOR FURTHER INFORMATION CONTACT: electronically transmit data required by
Michael J. Lewis, Diversion Control the DEA directly through ACE; this
RIN 1117–AB41 Division, Drug Enforcement electronic process replaces certain
Administration; Mailing Address: 8701 paper-based processes that are used
Revision of Import and Export Morrissette Drive, Springfield, Virginia outside of the pilot program. The test
Requirements for Controlled 22152; Telephone: (202) 598–6812. commenced on August 1, 2016, and will
Substances, Listed Chemicals, and continue until publication of a notice in
SUPPLEMENTARY INFORMATION: The Drug
Tableting and Encapsulating the Federal Register. Any party seeking
Enforcement Administration (DEA) is
Machines, Including Changes To to participate in the test was instructed
updating its regulations for the import
Implement the International Trade Data to contact their CBP client
and export of tableting and
System (ITDS); Revision of Reporting representative. The pilot program will
encapsulating machines, controlled
Requirements for Domestic be concluded as of the effective date of
substances, and listed chemicals, and its
Transactions in Listed Chemicals and the final rule. At that time, all
regulations relating to reports required
Tableting and Encapsulating importers, exporters, and brokers will be
for domestic transactions in listed
Machines; and Technical Amendments able to use ACE to electronically file
chemicals, gamma-hydroxybutyric acid,
AGENCY: Drug Enforcement and tableting and encapsulating required data and documentation
Administration, Department of Justice. machines. In accordance with Executive associated with the importation and
ACTION: Final rule; delay of effective Order 13563, the DEA has reviewed its exportation of controlled substances and
date. import and export regulations and listed chemicals.
reporting requirements for domestic The DEA’s implementation of this
SUMMARY: On December 30, 2016, the transactions in listed chemicals (and action without opportunity for public
Drug Enforcement Administration gamma-hydroxybutyric acid) and comment is based on the good cause
published a final rule to implement tableting and encapsulating machines, exceptions in 5 U.S.C. 553(b)(B) because
requirements associated with the and evaluated them for clarity, seeking public comment is
International Trade Data System (ITDS) consistency, continued accuracy, and impracticable, unnecessary and contrary
that will help streamline the export/ effectiveness. The amendments clarify to the public interest. The temporary
import of tableting and encapsulating certain policies and reflect current delay in the effective date will allow
machines, controlled substances, and procedures and technological Department of Justice officials an
listed chemicals. That rule is scheduled advancements. The amendments also opportunity to review any potential
to become effective January 30, 2017. In allow for the implementation, as questions of fact, law and policy raised
accordance with the memorandum of applicable to tableting and by this regulation, consistent with the
January 20, 2017, from the Assistant to encapsulating machines, controlled Chief of Staff’s memorandum of January
the President and Chief of Staff, entitled substances, and listed chemicals, of the 20, 2017. Given the imminence of the
‘‘Regulatory Freeze Pending Review,’’ President’s Executive Order 13659 on rule’s effective date, seeking prior
this action hereby temporarily delays streamlining the export/import process public comment on this temporary
until March 21, 2017, the effective date and requiring the government-wide delay would have been impractical, as
mstockstill on DSK3G9T082PROD with RULES

of the final rule entitled ‘‘Revision of utilization of the International Trade well as contrary to the public interest in
Import and Export Requirements for Data System (ITDS). This rule the orderly promulgation and
Controlled Substances, Listed additionally contains amendments that implementation of regulations. For the
Chemicals, and Tableting and implement recent changes to the foregoing reasons, the good cause
Encapsulating Machines, Including Controlled Substances Import and exceptions in 5 U.S.C. 553(d)(3) also
Changes to Implement the International Export Act for reexportation of apply to DEA’s decision to make today’s
Trade Data System (ITDS); Revision of controlled substances among members action effective immediately.

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Federal Register / Vol. 82, No. 18 / Monday, January 30, 2017 / Rules and Regulations 8689

In accordance with the memorandum Priority Mail Contract 36 (MC2016–207 Package Service Contract 13 (MC2017–
of January 20, 2017, from the Assistant and CP2016–296); October 12, 2016, 22 and CP2017–42); December 13, 2016,
to the President and Chief of Staff, Priority Mail & First-Class Package Priority Mail Contract 261 (MC2017–28
entitled ‘‘Regulatory Freeze Pending Service Contract 34 (MC2016–211 and and CP2017–53); December 13, 2016,
Review’’ this action hereby temporarily CP2016–300); October 12, 2016, Priority Priority Mail Contract 259 (MC2017–26
delays until March 21, 2017, the Mail Contract 244 (MC2016–212 and and CP2017–51); December 13, 2016,
effective date of the final rule entitled CP2016–301); October 17, 2016, Priority Priority Mail Contract 260 (MC2017–27
‘‘Revision of Import and Export Mail Contract 245 (MC2017–1 and and CP2017–52); December 14, 2016,
Requirements for Controlled CP2017–1); October 17, 2016, Priority Priority Mail Contract 262 (MC2017–29
Substances, Listed Chemicals, and Mail Contract 246 (MC2017–2 and and CP2017–54); December 14, 2016,
Tableting and Encapsulating Machines, CP2017–2); October 17, 2016, Priority Priority Mail Contract 264 (MC2017–31
Including Changes to Implement the Mail Contract 247 (MC2017–3 and and CP2017–56); December 14, 2016,
International Trade Data System (ITDS); CP2017–3); October 17, 2016, Priority Priority Mail Contract 263 (MC2017–30
Revision of Reporting Requirements for Mail Express, Priority Mail & First-Class and CP2017–55); December 14, 2016,
Domestic Transactions in Listed Package Service Contract 11 (MC2017– Priority Mail Contract 265 (MC2017–32
Chemicals and Tableting and 4 and CP2017–4); October 25, 2016, and CP2017–57); December 15, 2016,
Encapsulating Machines; and Technical Priority Mail Express & Priority Mail Priority Mail Express, Priority Mail &
Amendments’’ (RIN 1117–AB41) Contract 37 (MC2017–6 and CP2017– First-Class Package Service Contract 14
published in the Federal Register on 12); October 25, 2016, Priority Mail (MC2017–33 and CP2017–58);
December 30, 2016, at 81 FR 96992. Contract 248 (MC2017–5 and CP2017– December 15, 2016, First-Class Package
Dated: January 25, 2017. 11); October 27, 2016, Parcel Select Service Contract 67 (MC2017–34 and
Chuck Rosenberg, Contract 17 (MC2016–200 and CP2016– CP2017–59); December 20, 2016,
Acting Administrator. 284); November 3, 2016, Priority Mail Priority Mail & First-Class Package
[FR Doc. 2017–01976 Filed 1–27–17; 8:45 am]
Contract 252 (MC2017–10 and CP2017– Service Contract 38 (MC2017–35 and
25); November 3, 2016, Priority Mail CP2017–60); December 20, 2016,
BILLING CODE 4410–09–P
Contract 253 (MC2017–11 and CP2017– Priority Mail & First-Class Package
26); November 3, 2016, Priority Mail Service Contract 39 (MC2017–36 and
Contract 249 (MC2017–7 and CP2017– CP2017–61); December 20, 2016,
POSTAL REGULATORY COMMISSION 22); November 3, 2016, Priority Mail Priority Mail & First-Class Package
39 CFR Part 3020 Contract 251 (MC2017–9 and CP2017– Service Contract 40 (MC2017–37 and
24); November 3, 2016, Priority Mail CP2017–62); December 20, 2016,
[Docket Nos. MC2010–21 and CP2010–36] Express Contract 43 (MC2017–12 and Priority Mail Express & Priority Mail
CP2017–27); November 3, 2016, Priority Contract 38 (MC2017–38 and CP2017–
Update to Competitive Product List Mail Contract 250 (MC2017–8 and 63); December 22, 2016, First-Class
AGENCY: Postal Regulatory Commission. CP2017–23); November 4, 2016, Priority Package Service Contract 69 (MC2017–
ACTION: Final rule. Mail & Parcel Select Contract 2 40 and CP2017–65); December 22, 2016,
(MC2017–13 and CP2017–29); Priority Mail Contract 268 (MC2017–43
SUMMARY: The Commission is updating November 7, 2016, Priority Mail Express and CP2017–68); December 22, 2016,
the competitive product list. This action Contract 42 (MC2016–208 and CP2016– Priority Mail Contract 266 (MC2017–41
reflects a publication policy adopted by 297); November 15, 2016, First-Class and CP2017–66); December 22, 2016,
Commission order. The referenced Package Service Contract 65 (MC2017– Priority Mail Contract 267 (MC2017–42
policy assumes periodic updates. The 14 and CP2017–30); November 15, 2016, and CP2017–67); December 22, 2016,
updates are identified in the body of Priority Mail Contract 255 (MC2017–16 First-Class Package Service Contract 68
this document. The competitive product and CP2017–32); November 15, 2016, (MC2017–39 and CP2017–64);
list, which is republished in its entirety, Priority Mail Contract 254 (MC2017–15 December 22, 2016, Priority Mail
includes these updates. and CP2017–31); November 23, 2016, Contract 269 (MC2017–44 and CP2017–
DATES: Effective Date: January 30, 2017. Priority Mail Contract 256 (MC2017–17 69); December 22, 2016, Priority Mail
Applicability Dates: October 4, 2016, and CP2017–36); November 23, 2016, Contract 270 (MC2017–45 and CP2017–
Priority Mail Contract 240 (MC2016–201 First-Class Package Service Contract 66 71); December 22, 2016, Priority Mail
and CP2016–290); October 4, 2016, (MC2017–20 and CP2017–39); Contract 271 (MC2017–46 and CP2017–
Priority Mail Contract 242 (MC2016–203 November 23, 2016, Priority Mail 72); December 23, 2016, Priority Mail
and CP2016–292); October 4, 2016, Contract 258 (MC2017–19 and CP2017– Contract 272 (MC2017–47 and CP2017–
Priority Mail Express & Priority Mail 38); November 28, 2016, Priority Mail 73); December 23, 2016, Priority Mail &
Contract 35 (MC2016–205 and CP2016– Express, Priority Mail & First-Class First-Class Package Service Contract 41
294); October 4, 2016, Priority Mail Package Service Contract 12 (MC2017– (MC2017–48 and CP2017–74);
Contract 241 (MC2016–202 and 21 and CP2017–41); November 29, 2016, December 23, 2016, Priority Mail
CP2016–291); October 4, 2016, Priority Priority Mail Contract 257 (MC2017–18 Express Contract 44 (MC2017–49 and
Mail Contract 243 (MC2016–204 and and CP2017–37); December 5, 2016, CP2017–75); December 23, 2016,
CP2016–293); October 5, 2016, First- Priority Mail & First-Class Package Priority Mail Contract 273 (MC2017–50
Class Package Service Contract 64 Service Contract 35 (MC2017–23 and and CP2017–76); December 27, 2016,
(MC2016–206 and CP2016–295); CP2017–43); December 5, 2016, Priority Priority Mail Contract 274 (MC2017–51
mstockstill on DSK3G9T082PROD with RULES

October 6, 2016, Priority Mail & First- Mail & First-Class Package Service and CP2017–77); December 27, 2016,
Class Package Service Contract 32 Contract 36 (MC2017–24 and CP2017– Priority Mail Contract 275 (MC2017–52
(MC2016–209 and CP2016–298); 44); December 5, 2016, Priority Mail & and CP2017–78); December 27, 2016,
October 6, 2016, Priority Mail & First- First-Class Package Service Contract 37 Priority Mail & First-Class Package
Class Package Service Contract 33 (MC2017–25 and CP2017–45); Service Contract 42 (MC2017–56 and
(MC2016–210 and CP2016–299); December 5, 2016, Priority Mail CP2017–82); December 27, 2016,
October 6, 2016, Priority Mail Express & Express, Priority Mail & First-Class Priority Mail Contract 277 (MC2017–54

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Document Created: 2017-01-28 01:25:58
Document Modified: 2017-01-28 01:25:58

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; delay of effective date.
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.
Contact		Michael J. Lewis, Diversion Control
FR Citation		82 FR 8688
RIN Number		1117-AB41
CFR Citation		21 CFR 1300 21 CFR 1301 21 CFR 1302 21 CFR 1303 21 CFR 1304 21 CFR 1308 21 CFR 1309 21 CFR 1310 21 CFR 1312 21 CFR 1313 21 CFR 1314 21 CFR 1315 21 CFR 1316 21 CFR 1321

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 82, Issue 18 (January 30, 2017)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration