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Q: SECTION 1. SHORT TITLE; AMENDMENT OF 1986 CODE.

(a) Short Title.--This Act may be cited as the ''Tobacco Smuggling
Eradication Act of 2002''.

TITLE I--AMENDMENTS TO INTERNAL REVENUE CODE OF 1986

SEC. 101. AMENDMENT OF 1986 CODE.

Except as otherwise expressly provided, whenever in this title an
amendment or repeal is expressed in terms of an amendment to, or repeal
of, a section or other provision, the reference shall be considered to
be made to a section or other provision of the Internal Revenue Code of
1986.

SEC. 102. IMPROVED MARKING AND LABELING.

(a) In General.--Subsection (b) of section 5723 (relating to marks,
labels, and notices) is amended--
(1) by striking '', if any,'' and
(2) by adding at the end the following: ''Such marks,
labels, and notices shall include marks and notices relating to
the following:
''(1) Identification.--The Secretary shall promulgate
regulations that require each manufacturer or importer of
tobacco products to legibly print a unique serial number on all
packages of tobacco products manufactured or imported for sale
or distribution. Such serial number shall be designed to enable
the Secretary to identify the manufacturer or importer of the
product, and the location and date of manufacture or
importation. The Secretary shall determine the size and
location of the serial number.
''(2) Marking requirements for exports.--Each package of a
tobacco product that is exported shall be marked for export
from the United States. The Secretary shall promulgate
regulations to determine the size and location of the mark and
under what circumstances a waiver of this paragraph shall be
granted.''.
(b) Sales on Indian Reservations.--Section 5723 is amended by
adding at the end the following new subsections:
''(f) Sales on Indian Reservations.--The Secretary, in consultation
with the Secretary of the Interior, shall promulgate regulations that
require that each package of a tobacco product that is sold on an
Indian reservation (as defined in section 403(9) of the Indian Child
Protection and Family Violence Prevention Act (25 U.S.C. 3202(9)) be
labeled as such. Such regulations shall include requirements for the
size and location of the label.
''(g) Definition of Package.--For purposes of this section, the
term 'package' means the innermost sealed container irrespective of the
material from which such container is made, in which a tobacco product
is placed by the manufacturer and in which such tobacco product is
offered for sale to a member of the general public.''.

SEC. 103. WHOLESALERS REQUIRED TO HAVE PERMIT.

Section 5712 (relating to application for permit) is amended by
inserting '', wholesaler,'' after ''manufacturer''.

SEC. 104. CONDITIONS OF PERMIT.

Subsection (a) of section 5713 (relating to issuance of permit) is
amended to read as follows:
''(a) Issuance.--
''(1) In general.--A person shall not engage in business as
a manufacturer, wholesaler, or importer of tobacco products or
as an export warehouse proprietor without a permit to engage in
such business. Such permit shall be issued in such form and in
such manner as the Secretary shall by regulation prescribe, to
every person properly qualified under sections 5711 and 5712. A
new permit may be required at such other time as the Secretary
shall by regulation prescribe.
''(2) Conditions.--The issuance of a permit under this
section shall be conditioned upon the compliance with the
requirements of this chapter and the Contraband Cigarette
Trafficking Act (18 U.S.C. chapter 114), and any regulations
issued pursuant to such statutes.''.

SEC. 105. RECORDS TO BE MAINTAINED.

Section 5741 (relating to records to be maintained) is amended--
(1) by inserting ''(a) In General.--'' before ''Every
manufacturer'',
(2) by inserting ''every wholesaler,'' after ''every
importer,'',
(3) by striking ''such records'' and inserting ''records
concerning the chain of custody of the tobacco products and
such other records'', and
(4) by adding at the end the following new subsection:
''(b) Retailers.--Retailers shall maintain records of receipt of
tobacco products, and such records shall be available to the Secretary
for inspection and audit. An ordinary commercial record or invoice
shall satisfy the requirements of this subsection if such record shows
the date of receipt, from whom tobacco products were received, and the
quantity of tobacco products received.''.

SEC. 106. REPORTS.

Section 5722 (relating to reports) is amended--
(1) by inserting ''(a) In General.--'' before ''Every
manufacturer'', and
(2) by adding at the end the following new subsection:
''(b) Reports By Export Warehouse Proprietors.--
''(1) In general.--Prior to exportation of tobacco products
from the United States, the export warehouse proprietor shall
submit a report (in such manner and form as the Secretary may
by regulation prescribe) to enable the Secretary to identify
the shipment and assure that it reaches its intended
destination.
''(2) Agreements with foreign governments.--Notwithstanding
section 6103 of this title, the Secretary is authorized to
enter into agreements with foreign governments to exchange or
share information contained in reports received from export
warehouse proprietors of tobacco products if--
''(A) the Secretary believes that such agreement
will assist in--
''(i) ensuring compliance with the
provisions of this chapter or regulations
promulgated thereunder, or
''(ii) preventing or detecting violations
of the provisions of this chapter or
regulations promulgated thereunder, and
''(B) the Secretary obtains assurances from such
government that the information will be held in
confidence and used only for the purposes specified in
clauses (i) and (ii) of subparagraph (A).
No information may be exchanged or shared with any government
that has violated such assurances.''.

SEC. 107. FRAUDULENT OFFENSES.

(a) In General.--Subsection (a) of section 5762 (relating to
fraudulent offenses) is amended by striking paragraph (1) and
redesignating paragraphs (2) through (6) as paragraphs (1) through (5),
respectively.
(b) Offenses Relating to Distribution of Tobacco Products.--Section
5762 is amended--
(1) by redesignating subsection (b) as subsection (c),
(2) in subsection (c) (as so redesignated), by inserting
''or (b)'' after ''(a)'', and
(3) by inserting after subsection (a) the following new
subsection:
''(b) Offenses Relating to Distribution of Tobacco Products.--It
shall be unlawful--
''(1) for any person to engage in the business as a
manufacturer or importer of tobacco products or cigarette
papers and tubes, or to engage in the business as a wholesaler
or an export warehouse proprietor, without filing the bond and
obtaining the permit where required by this chapter or
regulations thereunder;
''(2) for a manufacturer, importer, or wholesaler permitted
under this chapter intentionally to ship, transport, deliver,
or receive any tobacco products from or to any person other
than a person permitted under this chapter or a retailer,
except a permitted importer may receive foreign tobacco
products from a foreign manufacturer or a foreign distributor
that have not previously entered the United States;
''(3) for any person (other than the original manufacturer
of such tobacco products or an export warehouse proprietor
authorized to receive any tobacco products that have previously
been exported and returned to the United States) to receive any
tobacco products that have previously been exported and
returned to the United States;
''(4) for any export warehouse proprietor intentionally to
ship, transport, sell, or deliver for sale any tobacco products
to any person other than the original manufacturer of such
tobacco products, another export warehouse proprietor, or a
foreign purchaser;
''(5) for any person (other than a manufacturer or an
export warehouse proprietor permitted under this chapter)
intentionally to ship, transport, receive, or possess, for
purposes of resale, any tobacco product in packages marked
pursuant to regulations issued under section 5723, other than
for direct return to a manufacturer for repacking or for re-
exportation or to an export warehouse proprietor for re-
exportation;
''(6) for any manufacturer, importer, export warehouse
proprietor, or wholesaler permitted under this chapter to make
intentionally any false entry in, to fail willfully to make
appropriate entry in, or to fail willfully to maintain properly
any record or report that such person is required to keep as
required by this chapter or the regulations promulgated
thereunder; and
''(7) for any person to alter, mutilate, destroy,
obliterate, or remove any mark or label required under this
chapter upon a tobacco product held for sale, except pursuant
to regulations of the Secretary authorizing relabeling for
purposes of compliance with the requirements of this section or
of State law.
Any person violating any of the provisions of this subsection shall,
upon conviction, be fined as provided in section 3571 of title 18,
United States Code, imprisoned for not more than 5 years, or both.''.
(c) Intentionally Defined.--Section 5762 is amended by adding at
the end the following:
''(d) Definition of Intentionally.--For purposes of this section
and section 5761, the term 'intentionally' means doing an act, or
omitting to do an act, deliberately, and not due to accident,
inadvertence, or mistake, regardless of whether the person knew that
the act or omission constituted an offense.''.

SEC. 108. CIVIL PENALTIES.

Subsection (a) of section 5761 (relating to civil penalties) is
amended--
(1) by striking ''willfully'' and inserting
''intentionally'', and
(2) by striking ''$1,000'' and inserting ''$10,000''.

SEC. 109. DEFINITIONS.

(a) Export Warehouse Proprietor.--Subsection (i) of section 5702
(relating to definition of export warehouse proprietor) is amended by
inserting before the period the following: ''or any person engaged in
the business of exporting tobacco products from the United States for
purposes of sale or distribution. Any duty free store that sells,
offers for sale, or otherwise distributes to any person in any single
transaction more than 30 packages of cigarettes, or its equivalent for
other tobacco products as the Secretary shall by regulation prescribe,
shall be deemed an export warehouse proprietor under this chapter''.
(b) Retailer; Wholesaler.--Section 5702 is amended by adding at the
end the following:
''(p) Retailer.--The term 'retailer' means any dealer who sells, or
offers for sale, any tobacco product at retail. The term 'retailer'
includes any duty-free store that sells, offers for sale, or otherwise
distributes at retail in any single transaction 30 or less packages, or
its equivalent for other tobacco products.
''(q) Wholesaler.--The term 'wholesaler' means any person engaged
in the business of purchasing tobacco products for resale at wholesale,
or any person acting as an agent or broker for any person engaged in
the business of purchasing tobacco products for resale at wholesale.''.

SEC. 110. EFFECTIVE DATE.

The amendments made by this title shall take effect on January 1,
2003.

TITLE II--AMENDMENTS TO THE CONTRABAND CIGARETTE TRAFFICKING ACT

SEC. 201. AMENDMENTS TO THE CONTRABAND CIGARETTE TRAFFICKING ACT.

(a) Definitions.--Section 2341 of title 18, United States Code, is
amended--
(1) in paragraph (2)--
(A) by striking ''60,000'' and inserting
''30,000'', and
(B) by inserting ''or importer'' after ''as a
manufacturer'';
(2) in paragraph (4), by striking ''and'' at the end;
(3) in paragraph (5), by striking the period and inserting
a semicolon; and
(4) by adding at the end the following:
''(6) the term 'tobacco product' means cigars, cigarettes,
smokeless tobacco, and pipe tobacco (as such terms are defined
in section 5701 of the Internal Revenue Code of 1986); and
''(7) the term 'contraband tobacco product' means a
quantity of tobacco product that is equivalent to or more than
30,000 cigarettes as determined by regulation, which bear no
evidence of the payment of applicable State tobacco taxes in
the State where such tobacco products are found, if such State
requires a stamp, impression, or other indication to be placed
on packages or other containers of product to evidence payment
of tobacco taxes.''
(b) Unlawful Acts.--Section 2342 of title 18, United States Code,
is amended--
(1) in subsection (a), by inserting ''or contraband tobacco
products'' before the period;
(2) by amending subsection (b) to read as follows:
''(b)(1) It shall be unlawful for any person--
''(A) knowingly to make any false statement or
representation with respect to the information required by this
chapter to be kept in the records or reports of any person who
ships, sells, or distributes--
''(i) any quantity of cigarettes in excess of
30,000 in a single transaction or in a series of
related transactions, or
''(ii) tobacco products in such equivalent
quantities as shall be determined by regulation, or
''(B) knowingly to fail to maintain records or reports,
alter or obliterate required markings, or interfere with any
inspection, required under this chapter, with respect to such
quantity of cigarettes or other tobacco products.''; and
(3) by adding at the end the following:
''(c) It shall be unlawful for any person knowingly to transport
tobacco products under a false bill of lading or without any bill of
lading.''.
(c) Recordkeeping.--Section 2343 of title 18, United States Code,
is amended--
(1) in subsection (a), by striking ''60,000 in a single
transaction'' and inserting ''30,000 in a single transaction or
in a series of related transactions, or, in the case of other
tobacco products an equivalent quantity as determined by
regulation,'';
(2) by amending the last sentence of subsection (a) to read
as follows: ''Except as provided in subsection (c) of this
section, nothing contained herein shall authorize the Secretary
to require reporting under this section.'';
(3) in subsection (b), by striking ''60,000 in a single
transaction'' and inserting ''30,000 in a single transaction or
in a series of related transactions, or, in the case of other
tobacco products an equivalent quantity as determined by
regulation,''; and
(4) by adding at the end the following:
''(c)(1) Any person who ships, sells, or distributes tobacco
products for resale in interstate commerce, whereby such tobacco
products are shipped into a State taxing the sale or use of such
tobacco products or who advertises or offers tobacco products for such
sale or transfer and shipment shall--
''(A) first file with the tobacco tax administrator of the
State into which such shipment is made or in which such
advertisement or offer is disseminated, a statement setting for
the person's name, and trade name (if any), and the address of
the person's principal place of business and of any other place
of business; and
''(B) not later than the 10th of each calendar month, file
with the tobacco tax administrator of the State into which such
shipment is made a memorandum or a copy of the invoice covering
each and every shipment of tobacco products made during the
previous calendar month into such State; the memorandum or
invoice in each case to include the name and address of the
person to whom the shipment was made, the brand, and the
quantity thereof.
''(2) The fact that any person ships or delivers for shipment any
tobacco products shall, if such shipment is into a State in which such
person has filed a statement with the tobacco tax administrator under
paragraph (1)(A) of this subsection, be presumptive evidence that such
tobacco products were sold, shipped, or distributed for resale by such
person.
''(3) For purposes of this subsection--
''(A) the term 'use' in addition to its ordinary meaning,
means consumption, storage, handling, or disposal of tobacco
products; and
''(B) the term 'tobacco tax administrator' means the State
official authorized to administer tobacco tax laws of the
State.''.
(d) Penalties.--Section 2344 of title 18, United States Code, is
amended--
(1) in subsection (b), by inserting ''or (c)'' after
''section 2342(b)'' and by inserting ''or (c)'' after section
2343(a)''; and
(2) by striking subsection (c) and inserting the following
new subsection:
''(c) Any contraband cigarettes or contraband tobacco products
involved in any violation of the provisions of this chapter shall be
subject to seizure and forfeiture, and all provisions of section
9703(o) of title 31, United States Code, shall, so far as applicable,
extend to seizures and forfeitures under the provisions of this
chapter.''
(e) Repeal.--The Act of October 19, 1949, entitled ''An Act to
assist States in collecting sales and use taxes on cigarettes'', 63
Stat. 884 (chapter 10A of title 15, U.S.C.), is hereby repealed.

A: Tobacco Smuggling Eradication Act of 2002 - Amends chapter 52 (Tobacco Products and Cigarette Papers and Tubes) of the Internal Revenue Code to require all packages of tobacco products to carry a unique legibly printed serial number by which the Secretary of the Treasury can identify the manufacturer or importer and the location and date of manufacture or importation. Requires tobacco products sold on Indian reservations to be labeled as such.Requires a tobacco wholesaler to have a permit and to maintain certain records.Requires export warehouse proprietors to file certain reports with the Secretary. Authorizes the Secretary to enter into certain tobacco related information agreements with foreign countries.Establishes new offenses relating to the distribution of tobacco.Raises the $1,000 civil penalty under chapter 52 to $10,000.Amends the Contraband Cigarette Trafficking Act to: (1) expand the applicability of such Act from cigarettes only to "tobacco product" (cigars, cigarettes, smokeless tobacco, and pipe tobacco); (2) define "contraband tobacco product" as a quantity of tobacco product that is equivalent to or more than 30,000 cigarettes (currently, 60,000) which bear no evidence of the payment of applicable State tobacco taxes; (3) establish new unlawful acts; and (4) require additional recordkeeping.Repeals Federal law provisions concerning reports required to State tobacco tax administrators by individuals engaged in interstate cigarette commerce.
****
Q: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Saver's Bonus Act of 2007''.

SEC. 2. FINDINGS.

Congress finds the following:
(1) According to the Department of Commerce, Americans are
currently saving less than 1 percent of their disposable
income.
(2) According to the Federal Reserve's 2004 Survey of
Consumer Finances, 17 percent of all households have zero or
negative net worth, while 30 percent have net worth of less
than $10,000.
(3) According to the Federal Reserve's 2004 Survey of
Consumer Finances, 11 percent of households do not have a
checking account and 9 percent do not have a transaction
account of any kind.
(4) According to the Retirement Security Project, in 2004
more than half of all households had zero savings in an
employer-based 401(k)-type plan or tax-preferred savings plan
account.
(5) It is in the economic interests of the United States to
promote savings among all members of society, regardless of
income.

SEC. 3. SAVER'S BONUS.

(a) In General.--The Secretary of the Treasury shall develop a
program to match deposits made by qualifying low-income individuals
into designated savings products.
(b) Qualifying Low-Income Individuals.--For purposes of this Act,
the term ''qualifying low-income individual'' means any individual
determined by the Secretary of the Treasury to be eligible for the
saver's bonus under this Act.
(c) Designated Savings Products.--For purposes of this Act, the
term ''designated savings product'' means any savings product,
including--
(1) qualified retirement plans (as defined in section
4974(c)) of such Code,
(2) qualified tuition programs under section 529 of such
Code,
(3) Coverdell education savings accounts under section 530
of such Code,
(4) United States savings bonds,
(5) certificates of deposits with durations of at least 6
months, and
(6) other types of savings products considered appropriate
by the Secretary of the Treasury for the purposes of this Act.
(d) Saver's Bonus Program.--The program established under
subsection (a) shall provide that--
(1) qualifying low-income individuals who direct their
Federal income tax refund (in its entirety or a portion
thereof) be deposited into any designated savings product shall
be eligible for a dollar-for-dollar match or saver's bonus to
be deposited directly in any designated savings product,
(2) qualifying low-income individuals who claim (when
filing a Federal income tax return) to have deposited funds
into any designated savings product during the course of the
tax year shall be eligible for a saver's bonus to be deposited
directly into any designated savings product, and
(3) the saver's bonus--
(A) shall equal $500 for qualifying low-income
individuals who are eligible for the earned income
credit under section 32 of such Code and shall be
phased out (but not below zero) for such individuals
whose earned income exceeds 120 percent of the earned
income threshold at which such eligibility ceases,
(B) shall be indexed for inflation every 5 years,
and
(C) shall be considered a refundable credit for
purposes of the Internal Revenue Code of 1986.
(e) Conforming Amendment Regarding Funding of Saver's Bonus.--
Section 1324(b)(2) of title 31, United States Code, is amended by
inserting ''or enacted by the Saver's Bonus Act of 2007,''.
(f) Effective Date.--The program under, and amendment made by, this
section shall be effective with respect to Federal income tax returns
for taxable years beginning after December 31, 2008.

SEC. 4. OPENING OF ACCOUNTS ON FEDERAL INCOME TAX RETURNS TO FACILITATE
SAVINGS.

(a) Notification of Option.--
(1) In general.--The Commissioner of Internal Revenue shall
notify qualifying low-income individuals who qualify for a
Federal income tax refund but fail to provide an ACH direct
deposit number on their Federal income tax return that they
have the option of an electronic direct deposit and that they
may be eligible for the saver's bonus program under section 3
if they deposit a refund or a portion of their refund in any
designated savings product.
(2) Method of notification.--The notification under
paragraph (1) shall be made through--
(A) a public awareness program undertaken by the
Secretary of the Treasury, in concert with the
Commissioner of the Internal Revenue and others as
necessary, at least 6 months before January 2009, and
(B) the inclusion of such a notice in the
instruction material for any Federal income tax return.
(b) Establishment of Designated Account Program.--The Secretary of
the Treasury shall develop, in consultation with the Federal Management
System, a program to minimize the delivery of non-electronic Federal
income tax refunds by depositing refunds electronically to an account
held by a depository institution. This program shall include--
(1) provisions for such tax refunds to be deposited into a
designated account,
(2) establishment of account parameters with respect to
minimum balance requirements and limitations on overdrafts,
overdraft fees, and other requirements,
(3) establishment of means for the taxpayer to access the
account electronically or through a payment card, and
(4) provisions to allow taxpayers to open an account with
their Federal income tax refunds through financial service
providers, so long such account is held at a depository
institution that is insured under the Federal Deposit Insurance
Act (12 U.S.C. 1811 et seq.).
(c) Effective Date.--The notification under subsection (a) and the
program under subsection (b) shall be effective with respect to Federal
income tax returns for taxable years beginning after December 31, 2008.

SEC. 5. PURCHASE OF SAVINGS BONDS ON FEDERAL INCOME TAX RETURNS.

(a) Notification of Option.--The Commissioner of Internal Revenue
shall notify individual taxpayers that they have the option of
purchasing United States savings bonds when they file their Federal
income tax returns and that they may be eligible for the saver's bonus
program under section 3. Such notification shall be included in the
instruction material for any Federal income tax return.
(b) Establishment of Savings Bond Purchase Program.--The Secretary
of the Treasury shall develop, in consultation with a task force, a
program for the purchase by individual taxpayers of United States
savings bonds on their Federal income tax returns.
(c) Effective Date.--The notification under subsection (a) and the
program under subsection (b) shall be effective with respect to Federal
income tax returns for taxable years beginning after December 31, 2008.

A: Saver's Bonus Act of 2007 [sic] - Directs the Secretary of the Treasury to develop programs to: (1) match deposits made by low-income individuals into certain savings accounts (saver's bonus); (2) deposit tax refunds electronically into savings accounts; and (3) allow individual taxpayers to purchase U.S. savings bonds on their federal income tax returns.

Requires the Commissioner of the Internal Revenue Service (IRS) to notify low-income taxpayers of their eligibility for the saver's bonus and of their options under this Act.
****
Q: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Regulatory Transparency, Patient
Access, and Effective Drug Enforcement Act of 2014''.

SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW FDA-APPROVED DRUGS.

Section 201 of the Controlled Substances Act (21 U.S.C. 811) is
amended by inserting after subsection (h) the following:
''(i) Within 45 days of receiving a recommendation from the
Secretary to add a drug or substance that has never been marketed in
the United States to a schedule under this title, the Attorney General
shall, without regard to the findings required by subsection (a) of
this section or section 202(b), issue an interim final rule, under the
exception for good cause described in subparagraph (B) of section
553(b) of title 5, United States Code, placing the drug or substance
into the schedule recommended by the Secretary. The interim final rule
shall be made immediately effective under section 553(d)(3) of title 5,
United States Code.''.

SEC. 3. ENHANCING NEW DRUG DEVELOPMENT.

Section 302 of the Controlled Substances Act (21 U.S.C. 822) is
amended by inserting after subsection (g) the following:
''(h)(1) A person who submits an application for registration to
manufacture or distribute a controlled substance in accordance with
this section may indicate on the registration application that the
substance will be used only in connection with clinical trials of a
drug in accordance with section 505(i) of the Federal Food, Drug, and
Cosmetic Act.
''(2) When an application for registration to manufacture or
distribute a controlled substance includes an indication that the
controlled substance will be used only in connection with clinical
trials of a drug in accordance with section 505(i) of the Federal Food,
Drug, and Cosmetic Act, the Attorney General shall--
''(A) make a final decision on the application for
registration within 180 days; or
''(B) provide notice to the applicant in writing of--
''(i) the outstanding issues that must be resolved
in order to reach a final decision on the application;
and
''(ii) the estimated date on which a final decision
on the application will be made.''.

SEC. 4. REGISTRATION PROCESS UNDER CONTROLLED SUBSTANCES ACT.

(a) Definitions.--
(1) Factors as may be relevant to and consistent with the
public health and safety.--Section 303 of the Controlled
Substances Act (21 U.S.C. 823) is amended by adding at the end
the following:
''(i) In this section, the phrase 'factors as may be relevant to
and consistent with the public health and safety' means factors that
are relevant to and consistent with the findings contained in section
101.''.
(2) Imminent danger to the public health or safety.--
Section 304(d) of the Controlled Substances Act (21 U.S.C.
824(d)) is amended--
(A) by striking ''(d) The Attorney General'' and
inserting ''(d)(1) The Attorney General''; and
(B) by adding at the end the following:
''(2) In this subsection, the phrase 'imminent danger to the public
health or safety' means that, in the absence of an immediate suspension
order, controlled substances will continue to be distributed or
dispensed by a registrant who knows or should know through fulfilling
the obligations of the registrant under this Act, or has reason to
believe that--
''(A) the dispensing is outside the usual course of
professional practice;
''(B) the distribution or dispensing poses a present or
foreseeable risk of adverse health consequences or death due to
the abuse or misuse of the controlled substances; or
''(C) the controlled substances will continue to be
diverted outside of legitimate distribution channels.''.
(b) Opportunity To Submit Corrective Action Plan Prior to
Revocation or Suspension.--Subsection (c) of section 304 of the
Controlled Substances Act (21 U.S.C. 824) is amended--
(1) by striking the last two sentences;
(2) by striking ''(c) Before'' and inserting ''(c)(1)
Before''; and
(3) by adding at the end the following:
''(2) An order to show cause under paragraph (1) shall--
''(A) contain a statement of the basis for the denial,
revocation, or suspension, including specific citations to any
laws or regulations alleged to be violated by the applicant or
registrant;
''(B) direct the applicant or registrant to appear before
the Attorney General at a time and place stated in the order,
but not less than 30 days after the date of receipt of the
order; and
''(C) notify the applicant or registrant of the opportunity
to submit a corrective action plan on or before the date of
appearance.
''(3) Upon review of any corrective action plan submitted by an
applicant or registrant pursuant to paragraph (2), the Attorney General
shall determine whether denial, revocation or suspension proceedings
should be discontinued, or deferred for the purposes of modification,
amendment, or clarification to such plan.
''(4) Proceedings to deny, revoke, or suspend shall be conducted
pursuant to this section in accordance with subchapter II of chapter 5
of title 5, United States Code. Such proceedings shall be independent
of, and not in lieu of, criminal prosecutions or other proceedings
under this title or any other law of the United States.
''(5) The requirements of this subsection shall not apply to the
issuance of an immediate suspension order under subsection (d).''.

SEC. 5. REPORT TO CONGRESS ON EFFECTS OF LAW ENFORCEMENT ACTIVITIES ON
PATIENT ACCESS TO MEDICATIONS.

(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs and the Director of the Centers for
Disease Control and Prevention, and in consultation with the
Administrator of the Drug Enforcement Administration and the Director
of National Drug Control Policy, shall submit a report to the
Committees on the Judiciary of the House of Representatives, the
Committee on Energy and Commerce of the House of Representatives, the
Committee on the Judiciary of the Senate, and the Committee on Health,
Education, Labor and Pensions of the Senate identifying--
(1) obstacles to legitimate patient access to controlled
substances;
(2) issues with diversion of controlled substances; and
(3) how collaboration between Federal, State, local, and
tribal law enforcement agencies and the pharmaceutical industry
can benefit patients and prevent diversion and abuse of
controlled substances.
(b) Consultation.--The report under subsection (a) shall
incorporate feedback and recommendations from the following:
(1) Patient groups.
(2) Pharmacies.
(3) Drug manufacturers.
(4) Common or contract carriers and warehousemen.
(5) Hospitals, physicians, and other health care providers.
(6) State attorneys general.
(7) Federal, State, local, and tribal law enforcement
agencies.
(8) Health insurance providers and entities that provide
pharmacy benefit management services on behalf of a health
insurance provider.
(9) Wholesale drug distributors.

A:
Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 - Amends the Controlled Substances Act to direct the Attorney General, within 45 days of receiving a recommendation from the Secretary of Health and Human Services (HHS) to add a drug or substance that has never been marketed in the United States to a schedule of controlled substances, to issue an interim final rule under the exception for good cause, placing it into the schedule recommended, effective immediately. Allows a person who submits an application for registration to manufacture or distribute a controlled substance to indicate on the registration application that the substance will be used only in connection with clinical trials of a drug. Requires the Attorney General to: (1) make a final decision on such application within 180 days, or (2) provide written notice to the applicant of the outstanding issues that must be resolved to reach a final decision and the estimated date on which such decision will be made. Defines: (1) "factors as may be relevant to and consistent with the public health and safety," and (2) "imminent danger to the public health or safety." Requires an order to show cause as to why a registration should not be denied, revoked, or suspended to notify the registrant of the opportunity to submit a corrective action plan on or before the date of appearance before the Attorney General. Requires the Attorney General, upon review of any such plan, to determine whether denial, revocation, or suspension proceedings should be discontinued or deferred for purposes of modification or clarification of such plan. Makes these requirements inapplicable to the issuance of an immediate suspension order. Directs the Secretary, acting through the Commissioner of Food and Drugs (FDA) and the Director of the Centers for Disease Control and Prevention (CDC), to identify: (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; and (3) how collaboration between federal, state, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances.
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