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21 U.S.C. § 2315 — Procedures for judicial review of classi-
Federal law — U.S. Code and appendices · legal_authorities
Page 1027
TITLE 21—FOOD AND DRUGS
§ 2315
tions under this subchapter with respect to an
entity that is owned or controlled, directly or
indirectly, by a foreign government or any po-
litical subdivision, agency, or instrumentality
of a foreign government, if, not less than 15
days before the waiver is to take effect, the
President certifies to the appropriate congres-
sional committees and leadership that the for-
eign government is closely cooperating with
the United States in efforts to prevent opioid
trafficking.
(2) Certification
The President may certify under paragraph
(1) that a foreign government is closely co-
operating with the United States in efforts to
prevent opioid trafficking if that government
is—
(A) implementing domestic laws to sched-
ule all fentanyl analogues as controlled sub-
stances; and
(B) doing two or more of the following:
(i) Implementing substantial improve-
ments in regulations involving the chem-
ical and pharmaceutical production and
export of illicit opioids.
(ii) Implementing substantial improve-
ments in judicial regulations to combat
transnational criminal organizations that
traffic opioids.
(iii) Increasing efforts to prosecute for-
eign opioid traffickers.
(iv) Increasing intelligence sharing and
law enforcement cooperation with the
United States with respect to opioid traf-
ficking.
(3) Subsequent renewal of waiver
The President may renew a waiver under
paragraph (1) for subsequent periods of not
more than 12 months each if, not less than 15
days before the renewal is to take effect, the
Secretary of State certifies to the appropriate
congressional committees and leadership that
the government of the country to which the
waiver applies has effectively implemented
and is effectively enforcing the me
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Page 1027
TITLE 21—FOOD AND DRUGS
§ 2315
tions under this subchapter with respect to an
entity that is owned or controlled, directly or
indirectly, by a foreign government or any po-
litical subdivision, agency, or instrumentality
of a foreign government, if, not less than 15
days before the waiver is to take effect, the
President certifies to the appropriate congres-
sional committees and leadership that the for-
eign government is closely cooperating with
the United States in efforts to prevent opioid
trafficking.
(2) Certification
The President may certify under paragraph
(1) that a foreign government is closely co-
operating with the United States in efforts to
prevent opioid trafficking if that government
is—
(A) implementing domestic laws to sched-
ule all fentanyl analogues as controlled sub-
stances; and
(B) doing two or more of the following:
(i) Implementing substantial improve-
ments in regulations involving the chem-
ical and pharmaceutical production and
export of illicit opioids.
(ii) Implementing substantial improve-
ments in judicial regulations to combat
transnational criminal organizations that
traffic opioids.
(iii) Increasing efforts to prosecute for-
eign opioid traffickers.
(iv) Increasing intelligence sharing and
law enforcement cooperation with the
United States with respect to opioid traf-
ficking.
(3) Subsequent renewal of waiver
The President may renew a waiver under
paragraph (1) for subsequent periods of not
more than 12 months each if, not less than 15
days before the renewal is to take effect, the
Secretary of State certifies to the appropriate
congressional committees and leadership that
the government of the country to which the
waiver applies has effectively implemented
and is effectively enforcing the measures that
formed the basis for the certification under
paragraph (2).
(b) Waivers for national security and access to
prescription medications
(1) In general
The President may waive the application of
sanctions under this subchapter if the Presi-
dent determines that the application of such
sanctions would harm—
(A) the national security interests of the
United States; or
(B) subject to paragraph (2), the access of
United States persons to prescription medi-
cations.
(2) Monitoring
The President shall establish a monitoring
program to verify that a person that receives
a waiver under paragraph (1)(B) is not traf-
ficking illicit opioids.
(3) Notification
Not later than 15 days after making a deter-
mination under paragraph (1), the President
shall notify the appropriate congressional
committees and leadership of the determina-
tion and the reasons for the determination.
(c) Humanitarian waiver
The President may waive, for renewable peri-
ods of 180 days, the application of the sanctions
under this subchapter if the President certifies
to the appropriate congressional committees
and leadership that the waiver is necessary for
the provision of humanitarian assistance.
(Pub. L. 116–92, div. F, title LXXII, § 7214, Dec. 20,
2019, 133 Stat. 2267.)
Editorial Notes
REFERENCES IN TEXT
This subchapter, referred to in subsecs. (a)(1), (b)(1),
and (c), was in the original ‘‘this subtitle’’, meaning
subtitle A (§§ 7211–7217) of title LXXII of div. F of Pub.
L. 116–92, which is classified principally to this sub-
chapter. For complete classification of subtitle A to
the Code, see Tables.
Executive Documents
DELEGATION OF FUNCTIONS
Functions and authorities of President under this
section delegated to Secretary of State, in consultation
with the Secretary of the Treasury, by section 1(b)(i) of
Memorandum of President of the United States, Mar.
31, 2020, 85 F.R. 22343, set out as a note under section
2311 of this title.
§ 2315. Procedures for judicial review of classi-
fied information
(a) In general
If a finding under this subchapter, or a prohi-
bition, condition, or penalty imposed as a result
of any such finding, is based on classified infor-
mation (as defined in section 1(a) of the Classi-
fied Information Procedures Act (18 U.S.C.
App.)) and a court reviews the finding or the im-
position of the prohibition, condition, or pen-
alty, the President may submit such informa-
tion to the court ex parte and in camera.
(b) Rule of construction
Nothing in this section shall be construed—
(1) to confer or imply any right to judicial
review of any finding under this subchapter, or
any prohibition, condition, or penalty imposed
as a result of any such finding; or
(2) to limit or restrict any other practice,
procedure, right, remedy, or safeguard that—
(A) relates to the protection of classified
information; and
(B) is available to the United States in
connection with any type of administrative
hearing, litigation, or other proceeding.
(Pub. L. 116–92, div. F, title LXXII, § 7215, Dec. 20,
2019, 133 Stat. 2268.)
Editorial Notes
REFERENCES IN TEXT
Section 1(a) of the Classified Information Procedures
Act, referred to in subsec.(a), is section 1(a) of Pub. L.
95–456, Oct. 15, 1980, 94 Stat. 2025, which is set out in the
Appendix to Title 18, Crimes and Criminal Procedure.
This subchapter, referred to in subsecs. (a) and (b)(1),
was in the original ‘‘this subtitle’’, meaning subtitle A
Page 1028
TITLE 21—FOOD AND DRUGS
§ 2316
(§§ 7211–7217) of title LXXII of div. F of Pub. L. 116–92,
which is classified principally to this subchapter. For
complete classification of subtitle A to the Code, see
Tables.
Executive Documents
DELEGATION OF FUNCTIONS
Functions and authorities of President under sub-
section (a) of this section delegated to Secretary of the
Treasury, in consultation with the Secretary of State,
by section 1(d)(viii) of Memorandum of President of the
United States, Mar. 31, 2020, 85 F.R. 22343, set out as a
note under section 2311 of this title.
§ 2316. Briefings on implementation
Not later than 90 days after December 20, 2019,
and every 180 days thereafter until the date that
is 5 years after December 20, 2019, the President,
acting through the Secretary of State and the
Director of National Intelligence, in coordina-
tion with the Secretary of the Treasury, shall
provide to the appropriate congressional com-
mittees and leadership a comprehensive briefing
on efforts to implement this subchapter.
(Pub. L. 116–92, div. F, title LXXII, § 7216, Dec. 20,
2019, 133 Stat. 2269.)
Editorial Notes
REFERENCES IN TEXT
This subchapter, referred to in text, was in the origi-
nal ‘‘this subtitle’’, meaning subtitle A (§§ 7211–7217) of
title LXXII of div. F of Pub. L. 116–92, which is classi-
fied principally to this subchapter. For complete classi-
fication of subtitle A to the Code, see Tables.
SUBCHAPTER II—OTHER MATTERS
§ 2331. Director of National Intelligence program
on use of intelligence resources in efforts to
sanction foreign opioid traffickers
(a) Program required
(1) In general
The Director of National Intelligence shall,
in consultation with the Director of the Office
of National Drug Control Policy, carry out a
program to allocate and enhance use of re-
sources of the intelligence community, includ-
ing intelligence collection and analysis, to as-
sist the Secretary of the Treasury, the Sec-
retary of State, and the Administrator of the
Drug Enforcement Administration in efforts
to identify and impose sanctions with respect
to foreign opioid traffickers under subchapter
I.
(2) Focus on illicit finance
To the extent practicable, efforts described
in paragraph (1) shall—
(A) take into account specific illicit fi-
nance risks related to narcotics trafficking;
and
(B) be developed in consultation with the
Undersecretary of the Treasury for Ter-
rorism and Financial Crimes, appropriate of-
ficials of the Office of Intelligence and Anal-
ysis of the Department of the Treasury, the
Director of the Financial Crimes Enforce-
ment Network, and appropriate Federal law
enforcement agencies.
(b) Review of counternarcotics efforts of the in-
telligence community
The Director of National Intelligence shall, in
coordination with the Director of the Office of
National Drug Control Policy, carry out a com-
prehensive review of the current intelligence
collection priorities of the intelligence commu-
nity for counternarcotics purposes in order to
identify whether such priorities are appropriate
and sufficient in light of the number of lives lost
in the United States each year due to use of ille-
gal drugs.
(c) Reports and briefings
(1) Reports and briefings on program
(A) Annual reports
Not later than 90 days after December 20,
2019, and annually thereafter, the Director of
National Intelligence and the Director of the
Office of National Drug Control Policy shall
jointly submit to the appropriate congres-
sional committees and leadership a report
on the status and accomplishments of the
program required by subsection (a) during
the year ending on the date of the report.
The first report under this subparagraph
shall also include a description of the
amount of funds devoted by the intelligence
community to the efforts described in sub-
section (a) during each of fiscal years 2017
and 2018.
(B) Semiannual briefings
On a semiannual basis, the Director of Na-
tional Intelligence and the Director of the
Office of National Drug Control Policy shall
jointly brief the appropriate congressional
committees and leadership on the status and
accomplishments of the program required by
subsection (a).
(2) Report on review
Not later than 120 days after December 20,
2019, the Director of National Intelligence, in
consultation with the Director of the Office of
National Drug Control Policy and other rel-
evant agencies, shall submit to the appro-
priate congressional committees and leader-
ship—
(A) a comprehensive description of the re-
sults of the review required by subsection
(b); and
(B) an assessment of whether—
(i) the priorities described in that sub-
section are appropriate and sufficient in
light of the number of lives lost in the
United States each year due to use of ille-
gal drugs; and
(ii) any changes to such priorities are
necessary.
(d) Intelligence community defined
In this section, the term ‘‘intelligence commu-
nity’’ has the meaning given that term in sec-
tion 3003(4) of title 50.
(Pub. L. 116–92, div. F, title LXXII, § 7231, Dec. 20,
2019, 133 Stat. 2273; Pub. L. 117–263, div. F, title
LXVIII, § 6811(h), Dec. 23, 2022, 136 Stat. 3601.)
Editorial Notes
REFERENCES IN TEXT
Subchapter I, referred to in subsec. (a)(1), was in the
original ‘‘subtitle A’’, meaning subtitle A (§§ 7211–7217)
Cross-references
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** If the Secretary of the Treasury determines that reasonable grounds exist for concluding that 1 or more financial institutions operating outside of the United States, 1 or more classes of transactions within, or involving, a jurisdiction outside of the United States, or 1 or more types of accounts within, or involving, a jurisdiction outside of the United States, is of primary money laundering concern in connection with illicit opioid trafficking, the Secretary of the Treasury may, by order, regulation, or otherwise as permitted by law—
(1) require domestic financial institutions and domestic financial agencies to take 1 or more of the special measures provided for in section 9714(a)(1) of the National Defense Authorization Act for Fiscal Year 2021 (Public Law 116–283; [31 U.S.C. 5318A](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section5318A&num=0&edition=prelim) note); or
(2) prohibit, or impose conditions upon, certain transmittals of funds (to be defined by the Secretary) by any domestic financial institution or domestic financial agency, if such transmittal of funds involves any such institution, class of transaction, or type of accounts.
**(b) Classified information** In any judicial review of a finding of the existence of a primary money laundering concern, or of the requirement for 1 or more special measures with respect to a primary money laundering concern made under this section, if the designation or imposition, or both, were based on classified information (as defined in section 1(a) of the Classified Information Procedures Act (18 U.S.C. App.)), such information may be submitted by the Secretary to the reviewing court ex parte and in camera. This subsection does not confer or imply any right to judicial review
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