SEC. 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Comprehensive
Fentanyl Control Act''.
    (b) Table of Contents.--The table of contents of this Act is as
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings; sense of Congress.
Sec. 3. Controlled substance analogues.
Sec. 4. Treatment of controlled substance analogues.
Sec. 5. Enhanced penalties.
Sec. 6. Endangering human life while illegally manufacturing controlled
                            substance.
Sec. 7. Temporary scheduling of synthetic opioid analgesics.
Sec. 8. Tableting machines, encapsulating machines, and controlled
                            substance counterfeiting materials.

SEC. 2. FINDINGS; SENSE OF CONGRESS.

    (a) Findings.--The Congress finds as follows:
            (1) Fentanyl is a dangerous, synthetic opioid that's 50 to
        100 times more potent than heroin and morphine and lethal in
        doses as small as approximately 2 milligrams. Current
        sentencing enhancements do not reflect the danger fentanyl
        poses at lower quantities compared to other illicit substances.
            (2) Because a lethal dose of fentanyl can be accidentally
        inhaled or absorbed through the skin, it's not just deadly to
        its users, but it also threatens the lives of law enforcement
        and customs officials, public health workers, first responders
        and postal workers who risk unknowingly coming into contact
        with fentanyl in its different forms.
            (3) From 2013 to 2014, the number of drug seizures by law
        enforcement that tested positive for fentanyl increased by 426
        percent and synthetic opioid-related deaths increased by 79
        percent, with over 700 overdose deaths related to fentanyl.
        However, due to variations in States' medical examiner and
        coroner testing and reporting techniques, and deaths attributed
        to heroin, this figure is believed to be significantly higher.
            (4) Illicitly manufactured fentanyl, pill press machines,
        and other supplies needed to manufacture counterfeit pills
        containing fentanyl are primarily sourced from China and widely
        available for purchase on the Internet. Traffickers can
        typically purchase a kilogram of fentanyl powder for as little
        as $2,000 from a Chinese supplier, transform it into hundreds
        of thousands of pills, and sell the counterfeit pills for
        millions of dollars in profit.
            (5) In 2015, the Drug Enforcement Administration (DEA) and
        Centers for Disease Control and Prevention (CDC) issued
        nationwide alerts identifying fentanyl as a threat to public
        health and safety and stating that the rise of counterfeit
        pills that contain fentanyl in the illicit drug market will
        likely result in more opioid-dependent individuals, overdoses,
        and deaths.
            (6) The DEA has identified two key challenges for using the
        Controlled Substances Analogue Enforcement Act of 1986 (21
        U.S.C. 801 note) to prosecute individuals for violations
        relating to fentanyl:
                    (A) The law requires that the substance have a
                substantially similar chemical structure to a
                controlled substance in order to be considered an
                analogue, yet the threshold for ``substantially
                similar'' has been cited by numerous courts as
                difficult to apply.
                    (B) Each case requires additional investigation to
                determine whether the substance in question was
                ``intended for human consumption'' and can therefore be
                considered an analogue.
            (7) Illicit fentanyl manufacturers are continuously
        manipulating the chemical structures of the analogues in order
        to stay ahead of researchers and law enforcement, thus making
        prosecuting these crimes overly onerous. Furthermore, the speed
        at which these alterations can be made outpace the current
        authorities of the Department of Justice to schedule new
        compounds and analogues under the Controlled Substances Act (21
        U.S.C. 801 et seq.).
    (b) Sense of Congress.--It is the sense of the Congress that--
            (1) the trafficking in fentanyl and other synthetic opioids
        represents a public health emergency in the United States and
        requires a comprehensive legislative response;
            (2) the United States Government should use all available
        measures to reduce the availability of illicit fentanyl, its
        chemical precursors, and the equipment by which fentanyl may be
        milled into counterfeit prescription pills;
            (3) the United States Government should make grants
        available for State and local medical examiners and coroners to
        screen for fentanyl in suspected opioid overdose cases in
        regions reporting increases in fentanyl seizures, fentanyl-
        related overdose fatalities, or unusually high spikes in heroin
        or unspecified drug overdose fatalities;
            (4) State and local law enforcement should, if safe and
        possible, prioritize and expedite testing of drug samples taken
        from drug overdose scenes and share the data on fentanyl drug
        seizures with local health departments, coroners, and medical
        examiners;
            (5) grants made available to address the opioid epidemic
        should be used to improve States' surveillance of fentanyl-
        related deaths and to expand access to naloxone for first
        responders, law enforcement, and health care personnel given
        that multiple doses of naloxone must be administered per
        overdose event; and
            (6) the United States Government, including the Secretary
        of State, the Attorney General, the Secretary of Homeland
        Security, and the Director of the Office of National Drug
        Control Policy, should use the broad diplomatic and law
        enforcement resources of the United States, in partnership with
        the Governments of Mexico and China, to stop the trafficking of
        illicit fentanyl into the United States.

SEC. 3. CONTROLLED SUBSTANCE ANALOGUES.

    (a) In General.--Clauses (i), (ii), and (iii) of section 102(32)(A)
of the Controlled Substances Act (21 U.S.C. 802(32)(A)) are amended by
striking ``substantially'' each place it appears.
    (b) Rule of Construction.--Section 102(32)(A) of the Controlled
Substances Act (21 U.S.C. 82(32)(A)) shall not be construed to require
that a substance satisfy more than one of the clauses listed in such
section 102(32)(A) to meet the definition of a controlled substance
analogue.

SEC. 4. TREATMENT OF CONTROLLED SUBSTANCE ANALOGUES.

    Section 203 of the Controlled Substances Act (21 U.S.C. 813) is
amended by striking ``shall, to the extent intended for human
consumption, be treated, for the purposes of any Federal law as a
controlled substance in schedule I'' and inserting ``shall, to the
extent to which it should be reasonably known to the manufacturer,
distributor, or dispenser that the controlled substance analogue is
intended for human consumption, be treated, with respect to such
manufacturer, distributor, or dispenser, respectively, for the purpose
of any Federal law as a controlled substance in schedule I''.

SEC. 5. ENHANCED PENALTIES.

    (a) Controlled Substances Act Amendments.--The Controlled
Substances Act is amended--
            (1) in section 401(b)(1) (21 U.S.C. 841(b)(1))--
                    (A) in subparagraph (A)(vi)--
                            (i) by striking ``400 grams'' and inserting
                        ``20 grams''; and
                            (ii) by striking ``100 grams'' and
                        inserting ``5 grams''; and
                    (B) in subparagraph (B)(vi)--
                            (i) by striking ``40 grams'' and inserting
                        ``2 grams''; and
                            (ii) by striking ``10 grams'' and inserting
                        ``0.5 grams''; and
            (2) by adding at the end of section 401(b) (21 U.S.C.
        841(b)) the following:
            ``(8) In the case of a violation of subsection (a), if the
        mixture or substance contains a detectable amount of N-phenyl-
        [1-(2-phenylethyl)-4-piperidinyl] propanamide or any analogue
        of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide and
        also contains a detectable amount of another controlled
        substance, then a court shall--
                    ``(A) not impose a term of probation;
                    ``(B) in addition to the term of punishment for the
                violation of this section, impose a term of
                imprisonment not to exceed 5 years; and
                    ``(C) no term of imprisonment imposed on a person
                under subparagraph (B) shall run concurrently with any
                term of imprisonment imposed on the person under any
                other provision of law.
            ``(9) In the case of a violation of subsection (a), if the
        mixture or substance containing a detectable amount of N-
        phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide or any
        analogue of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl]
        propanamide was represented to be or sold as another controlled
        substance, then a court shall--
                    ``(A) not impose a term of probation;
                    ``(B) in addition to the term of punishment for the
                violation of this section, impose a term of
                imprisonment not to exceed 5 years; and
                    ``(C) no term of imprisonment imposed on a person
                under subparagraph (B) shall run concurrently with any
                term of imprisonment imposed on the person under any
                other provision of law.''.
    (b) Controlled Substances Import and Export Act Amendments.--
Section 1010(b) of the Controlled Substances Import and Export Act (21
U.S.C. 960(b)) is amended by adding at the end the following:
            ``(8) In the case of a violation of subsection (a), if the
        mixture or substance containing a detectable amount of N-
        phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide or any
        analogue of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl]
        propanamide also contains a detectable amount of another
        controlled substance, then a court shall--
                    ``(A) not impose a term of probation;
                    ``(B) in addition to the term of punishment for the
                violation of this section, impose a term of
                imprisonment not to exceed 5 years; and
                    ``(C) no term of imprisonment imposed on a person
                under subparagraph (B) shall run concurrently with any
                term of imprisonment imposed on the person under any
                other provision of law.
            ``(9) In the case of a violation of subsection (a), if the
        mixture or substance containing a detectable amount of N-
        phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide or any
        analogue of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl]
        propanamide was represented to be or sold as another controlled
        substance, then a court shall--
                    ``(A) not impose a term of probation;
                    ``(B) in addition to the term of punishment for the
                violation of this section, impose a term of
                imprisonment not to exceed 5 years; and
                    ``(C) no term of imprisonment imposed on a person
                under subparagraph (B) shall run concurrently with any
                term of imprisonment imposed on the person under any
                other provision of law.''.

SEC. 6. ENDANGERING HUMAN LIFE WHILE ILLEGALLY MANUFACTURING CONTROLLED
              SUBSTANCE.

    Section 417 of the Controlled Substances Act (21 U.S.C. 858) is
amended to read as follows:

``SEC. 417. ENDANGERING HUMAN LIFE WHILE ILLEGALLY MANUFACTURING
              CONTROLLED SUBSTANCE.

    ``(a) In General.--Whoever, while manufacturing a controlled
substance in violation of this title, or attempting to do so, or
transporting or causing to be transported materials, including
chemicals, to do so, creates a substantial risk of harm to human life
shall be fined in accordance with title 18, United States Code, or
imprisoned not more than 10 years, or both.
    ``(b) Rebuttable Presumption.--For purposes of this section, there
shall be rebuttable presumption that any violation of subsection (a)
involving a detectable amount of N-phenyl-[1-(2-phenylethyl)-4-
piperidinyl] propanamide, any analogue of N-phenyl-[1-(2-phenylethyl)-
4-piperidinyl] propanamide, or the immediate precursor of such a
substance, creates a substantial risk of harm to human life.''.

SEC. 7. TEMPORARY SCHEDULING OF SYNTHETIC OPIOID ANALGESICS.

    Section 201 of the Controlled Substances Act (21 U.S.C. 811) is
amended by adding at the end the following:
    ``(k) Temporary Scheduling of Synthetic Opioid Analgesics.--
            ``(1) Issuance of order.--The Attorney General may, by
        order and without regard to the findings required by subsection
        (a) of this section or section 202(b) and without regard to the
        procedures prescribed by subsections (a) and (b) of this
        section, place a substance in schedule I if--
                    ``(A) the substance is not listed in any other
                schedule in section 202;
                    ``(B) no exemption, approval, or licensing is in
                effect for the substance under section 505 of the
                Federal Food, Drug, and Cosmetic Act or section 351 of
                the Public Health Service Act; and
                    ``(C) the Attorney General has reason to believe
                that such substance--
                            ``(i) is a synthetic opioid analgesic;
                            ``(ii) is the object or intended object of
                        clandestine importation, manufacture, or
                        distribution; and
                            ``(iii) poses an imminent hazard to public
                        health and safety.
            ``(2) Effective date of order.--An order issued under
        paragraph (1) may not take effect until 5 days after its
        publication in Federal Register.
            ``(3) Expiration of order.--An order issued under paragraph
        (1) shall expire not later than 6 months after the date on
        which it becomes effective, except that the Attorney General
        may extend the order for up to 6 months.
            ``(4) Conclusion of rulemaking.--An order issued under
        paragraph (1) with respect to a substance shall be vacated upon
        the conclusion of a subsequent rulemaking proceeding initiated
        under subsection (a) with respect to such substance.
            ``(5) Order not subject to judicial review.--An order
        issued under paragraph (1) is not subject to judicial
        review.''.

SEC. 8. TABLETING MACHINES, ENCAPSULATING MACHINES, AND CONTROLLED
              SUBSTANCE COUNTERFEITING MATERIALS.

    (a) Mailability.--
            (1) In general.--Chapter 30 of title 39, United States
        Code, is amended by inserting after section 3002a, the
        following new section:
``Sec. 3002b. Nonmailability of tableting machines, encapsulating
              machines, and controlled substance counterfeiting
              materials
    ``(a) Any tableting machine, encapsulating machine, or controlled
substance counterfeiting material is nonmailable matter, shall not be
carried or delivered by mail, and shall be disposed of as the Postal
Service directs, unless such device or material is mailed--
            ``(1) to a regulated person (as defined in section 102(38)
        of the Controlled Substances Act); or
            ``(2) to a person registered to manufacture a controlled
        substance by the Attorney General pursuant to section 302 of
        the Controlled Substances Act.
    ``(b) For the purpose of this section--
            ``(1) the `controlled substance counterfeiting material'
        means any punch, die, plate, stone, or other thing described
        section 403(a)(5) of the Controlled Substances Act;
            ``(2) the term `encapsulating machine' means any manual,
        semiautomatic, or fully automatic equipment which may be used
        to fill shells or capsules with any powdered, granular,
        semisolid, or liquid material; and
            ``(3) the term `tableting machine' means any manual,
        semiautomatic, or fully automatic equipment which may be used
        for the compaction or molding of powdered or granular solids,
        or semisolid material, to produce coherent solid tablets.''.
            (2) Clerical amendment.--The table of sections for chapter
        30 of title 39, United States Code, is amended by inserting
        after the item relating to section 3002a the following new
        item:

``3002b. Nonmailability of tableting machines, encapsulating machines,
                            and controlled substance counterfeiting
                            materials.''.
    (b) Penalty.--
            (1) In general.--Chapter 83 of title 18, United States
        Code, is amended by inserting after section 1716E the following
        new section:
``Sec. 1716F. Nonmailability of tableting machines, encapsulating
              machines, and controlled substance counterfeiting
              materials
    ``Whoever knowingly deposits for mailing or delivery, or knowingly
causes to be delivered by mail according to the direction thereon, or
at any place to which it is directed to be delivered by the person to
whom it is addressed, any matter declared to be nonmailable by section
3002c of title 39, shall be fined under this title or imprisoned not
more than 1 year, or both.''.
            (2) Clerical amendment.--The table of sections for chapter
        83 of title 18, United States Code, is amended by inserting
        after the item relating to section 1716E the following new
        item:

``1716F. Nonmailability of tableting machines, encapsulating machines,
                            and controlled substance counterfeiting
                            materials.''.

Summary: Comprehensive Fentanyl Control Act This bill amends the Controlled Substances Act (CSA) to modify the definition of quot, controlled substance analoguequot. To mean a substance that has a similar chemical structure and pharmacological effect to a schedule I controlled substance. Additionally, it modifies the treatment of controlled substance analogues. Under current law, a controlled substance analogue that is intended for human consumption is treated as a schedule I controlled substance. This bill replaces the intended for human consumption qualifier with a not a chemical substance subject to the Toxic Substances Control Act qualifier. Specifically, a controlled substance analogue that is not a chemical substance under the Toxic Substances Control Act is treated as a schedule I controlled substance. The bill modifies the drug quantity thresholds that trigger a mandatory minimum prison term for a defendant who manufactures, distributes, or possesses with intent to distribute fentanyl. It also establishes a consecutive mandatory prison term for a defendant who commits a drug offense involving a detectable amount of heroin or fentanyl. The bill allows the Drug Enforcement Administration to temporarily place a substance into schedule I if it reasonably believes that the substance: (1) is a synthetic opioid analgesic, (2) is the object of clandestine importation, manufacture, or distribution. And (3) poses an imminent hazard to public health and safety. Finally, the bill makes it a crime to knowingly mail to an unauthorized person equipment that may be used to manufacture counterfeit controlled substances.

Comprehensive Fentanyl Control Act


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Plan B for Plan B Act of 2005''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) The Food and Drug Administration has declared Plan B to
        be safe and effective in preventing unintended pregnancy,
        reducing the risk by as much as 89 percent if taken within days
        of unprotected intercourse and up to 95 percent if taken in the
        first 24 hours.
            (2) On April 21, 2003, product manufacturers Women's
        Capital Corporation, controlled by Barr Pharmaceuticals,
        submitted a supplemental new drug application to the Food and
        Drug Administration to switch Plan B from prescription-only to
        over-the-counter status for women of all ages.
            (3) On December 16, 2003, a joint panel of the Food and
        Drug Administration's Reproductive Health Drugs Advisory
        Committee and Non-Prescription Drugs Advisory Committee voted
        28-0 that Plan B could be used safely in a non-prescription
        setting.
            (4) On December 16, 2003, a joint panel of the Food and
        Drug Administration's Reproductive Health Drugs Advisory
        Committee and Non-Prescription Drugs Advisory Committee voted
        23-4 to recommend that the Food and Drug Administration approve
        the application to make Plan B available over-the-counter for
        women of all ages.
            (5) On May 6, 2004, the Food and Drug Administration deemed
        the application not approvable, directly contradicting the
        overwhelming weight of their own scientific evidence.
            (6) At the suggestion of the Food and Drug Administration,
        Barr Pharmaceutical submitted a formal response, dated July 16,
        2003, to the Administration's non-approvable determination,
        supporting the marketing of Plan B as a prescription drug for
        women 15 years of age or younger and a nonprescription drug for
        women 16 years of age or older.
            (7) On January 21, 2005, the Food and Drug Administration
        delayed issuing a decision on the Plan B application.
            (8) A letter dated July 13, 2005, from Secretary of Health
        and Human Services Michael O. Leavitt to Chairman Mike Enzi of
        the Committee on Health, Education, Labor, and Pensions of the
        Senate stated that the Food and Drug Administration would act
        on the Plan B application by September 1, 2005.
            (9) On August 26, 2005, the Food and Drug Administration
        did not approve or disapprove the Plan B application, and
        instead decided to publish an advance notice of proposed
        rulemaking in the Federal Register, even while concluding that
        ``the available scientific data are sufficient to support the
        safe use of Plan B as an OTC product . . . for women who are 17
        years of age or older''.
            (10) On August 31, 2005, Susan F. Wood, serving as the Food
        and Drug Administration's assistant commissioner for women's
        health and director of the Office of Women's Health, resigned
        her position because of the Administration's refusal to issue a
        final decision on the Plan B application, saying that she could
        not serve at the Administration when ``scientific and clinical
        evidence, fully evaluated and recommended for approval by the
        professional staff [at the Administration], has been
        overruled''.
            (11) On September 1, 2005, the Food and Drug Administration
        issued an advance notice of proposed rulemaking (70 FR 52050)
        to request comment by November 1, 2005, on whether to initiate
        a rulemaking to codify the Administration's interpretation of
        section 503(b) of the Federal Food, Drug, and Cosmetic Act (21
        U.S.C. 353(b)) regarding when an active ingredient may be
        simultaneously marketed in both a prescription drug product and
        an over-the-counter (OTC) drug product, potentially adding
        years of unnecessary regulatory delays to an already extended
        process which is keeping Plan B from over-the-counter status.

SEC. 3. DECISION BY FDA ON MARKETING OF EMERGENCY CONTRACEPTION.

    (a) In General.--Not later than 30 days after the date of the
enactment of this Act, the Commissioner of Food and Drugs shall approve
or disapprove the supplemental new drug application for Plan B, as
amended by the formal response to the non-approvable letter.
    (b) Failure to Approve or Disapprove.--If the Commissioner fails to
approve or disapprove the application described in subsection (a) by
the deadline described in such subsection--
            (1) the Commissioner is deemed to have approved the
        application; and
            (2) such deemed approval shall continue in effect unless
        the Commissioner publishes in the Federal Register a
        determination to approve or disapprove the application.
    (c) Definitions.--In this Act:
            (1) The term ``Commissioner'' means the Commissioner of
        Food and Drugs.
            (2) The term ``formal response'' means the formal response,
        dated July 16, 2003, to the non-approvable letter, supporting
        the marketing of Plan B as a prescription drug for women 15
        years of age or younger and a nonprescription drug for women 16
        years of age or older.
            (3) The term ``Plan B'' means 0.75 mg levonorgestrel
        tablets.
            (4) The term ``prescription drug'' means a drug subject to
        section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act
        (21 U.S.C. 353(b)(1)).
            (5) The term ``supplemental new drug application for Plan
        B'' means the supplemental new drug application submitted under
        section 505(b) of the Federal Food, Drug, and Cosmetic Act (21
        U.S.C. 355(b)) on April 21, 2003, by product manufacturers
        Women's Capital Corporation, controlled by Barr
        Pharmaceuticals, to the Food and Drug Administration to switch
        Plan B from prescription-only to nonprescription status for
        women of all ages.
            (6) The term ``non-approvable letter'' means the non-
        approvable letter dated May 6, 2004, from the Food and Drug
        Administration to Barr Pharmaceuticals.

Summary: Plan B for Plan B Act of 2005 - Requires the Commissioner of Food and Drugs to approve or disapprove within 30 days the supplemental new drug application submitted by Women's Capital Corporation for Plan B , as amended by a formal response to the Food and Drug Administration's non-approvable determination, that would switch the drug from prescription-only to nonprescription status for women 16 years or older. Deems the Commissioner as having approved the application if the deadline is not met and continues such approval unless the Commissioner publishes in the Federal Register a determination to approve or disapprove the application.

To require the Commissioner of Food and Drugs to determine whether to allow the marketing of Plan B as a prescription drug for women 15 years of age or younger and a nonprescription drug for women 16 years of age or older, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Coordinating Assistance for TANF
Recipients Act''.

SEC. 2. COORDINATED CASE MANAGEMENT DEMONSTRATION PROJECTS.

    Section 403 of the Social Security Act (42 U.S.C. 603) is amended
by adding at the end the following:
    ``(c) Coordinated Case Management Demonstration Projects.--
            ``(1) In general.--The Secretary shall make grants to
        States to conduct demonstration projects designed to implement
        and evaluate strategies to provide coordinated case management
        to help individuals receiving assistance under a State program
        funded under this part or any other State program funded with
        qualified State expenditures (as defined in section
        409(a)(7)(B)(i)) increase their employment and self-
        sufficiency.
            ``(2) Application requirements.--The Secretary shall
        require each State that applies for a grant under this
        paragraph to do the following:
                    ``(A) Describe how, using the funds provided under
                this paragraph, the State will develop an individual
                responsibility plan in accordance with section 408(b)
                for each recipient referred to in paragraph (1) of this
                subsection.
                    ``(B) Describe how the State will coordinate the
                development of this plan with other programs and
                agencies providing benefits and services to the
                individual to help the recipient increase the
                employment and self-sufficiency of the recipient.
                    ``(C) Describe how the State will coordinate the
                delivery of the benefits and services to the recipient
                (which may include the use of home visiting models).
                    ``(D) Describe how the State will meet with the
                recipient at least monthly to review the employment
                status of the recipient and status of the participation
                of the recipient in other activities, the benefits and
                services the recipient is receiving, and the progress
                of the recipient toward meeting the goals specified in
                the individual responsibility plan of the recipient.
            ``(3) Use of funds.--A State to which a grant is made under
        this subsection may use the grant for the following purposes:
                    ``(A) To support coordinated case managers in
                completing the activities specified in paragraph (2).
                    ``(B) To provide short-term transitional benefits
                and services to individuals who, due to increased
                employment or earnings, may face disincentives to
                increasing work or earnings due to the phase-out or
                loss of certain benefits.
                    ``(C) To ensure that recipients of services under
                the demonstration project have a choice between 2 or
                more coordinated case management service providers.
                    ``(D) To improve coordination between programs
                serving recipients who are part of the demonstration
                project.
                    ``(E) To improve coordination between information
                technology and other systems to deliver better benefits
                or services to the recipient, except that not more than
                10 percent of the grant amount may be used for this
                purpose.
            ``(4) Evaluation.--The Secretary, in consultation with each
        State conducting a demonstration project under this subsection,
        shall conduct a high-quality evaluation of the demonstration
        project in accordance with the following:
                    ``(A) Evaluator qualifications.--The Secretary may
                not enter into a contract with an evaluator unless the
                evaluator has demonstrated experience in conducting
                rigorous evaluations of program effectiveness
                including, where available and appropriate, well-
                implemented randomized controlled trials.
                    ``(B) Methodologies to be used.--The evaluation of
                a demonstration project shall use experimental designs
                using random assignment or other reliable, evidence-
                based research methodologies that allow for the
                strongest possible causal inferences when random
                assignment is not feasible.
                    ``(C) Public disclosure.--The Secretary shall
                publish the results of the evaluation on the website of
                the Department of Health and Human Services in a
                location easily accessible by the public.
                    ``(D) Limitation on cost of evaluations.--For
                evaluations under this paragraph, the Secretary may not
                obligate more than 20 percent of the funds reserved
                under paragraph (6) for each fiscal year.
            ``(5) Recommendations to congress.--The Secretary shall
        submit recommendations to the Congress on ways to improve case
        management and better coordinate benefits and services across
        programs.
            ``(6) Funding.--Of the amounts made available to carry out
        subsection (b) for fiscal year 2016 and each succeeding fiscal
        year, the Secretary shall reserve $300,000,000 to carry out
        this subsection.
            ``(7) Availability of funds.--Funds provided to a State
        under this subsection for a fiscal year shall be expended by
        the State in the fiscal year or in the succeeding fiscal
        year.''.

SEC. 3. EFFECTIVE DATE.

    The amendment made by this Act shall take effect on October 1,
2015.

Summary: Coordinating Assistance for TANF Recipients Act This bill amends part A (TANF) of the Social Security Act to direct the Department of Health and Human Services to make grants to states to conduct demonstration projects designed to implement and evaluate strategies to provide coordinated case management to help individuals receiving TANF assistance to increase their employment and self-sufficiency.


SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Lebanon and Syria
Liberation Act''.
    (b) Table of Contents.--The table of contents of this Act is as
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
    TITLE I--STRENGTHENING OF INTERNATIONAL SANCTIONS AGAINST SYRIA

Sec. 101. Declarations of policy.
Sec. 102. Codification of existing sanctions.
Sec. 103. Sanctions against certain persons.
Sec. 104. Sanctions against certain foreign countries.
Sec. 105. Diplomatic efforts.
Sec. 106. Report on assistance to, and commerce with, Syria.
TITLE II--ASSISTANCE TO SUPPORT DEMOCRACY IN SYRIA AND SOVEREIGNTY AND
                          DEMOCRACY IN LEBANON

Sec. 201. Declarations of policy.
Sec. 202. Assistance to support a transition to democracy in Syria and
                            restoration of sovereign democratic
                            governance in Lebanon.

SEC. 2. DEFINITIONS.

    In this Act:
            (1) Appropriate congressional committees.--The term
        ``appropriate congressional committees'' means--
                    (A) the Committee on International Relations and
                the Committee on Appropriations of the House of
                Representatives; and
                    (B) the Committee on Foreign Relations and the
                Committee on Appropriations of the Senate.
            (2) Person.--The term ``person'' means any United States or
        foreign individual, partnership, corporation, or other form of
        association, or any of their successor entities, parents or
        subsidiaries.
            (3) Syria.--The term ``Syria'' includes any agency or
        instrumentality of Syria.
            (4) United states assistance.--The term ``United States
        assistance'' means--
                    (A) any assistance under the Foreign Assistance Act
                of 1961 (22 U.S.C. 2251 et seq.), other than urgent
                humanitarian assistance or medicine;
                    (B) sales and assistance under the Arms Export
                Control Act (22 U.S.C. 2751 et seq.);
                    (C) financing by the Commodity Credit Corporation
                for export sales of agricultural commodities; and
                    (D) financing under the Export-Import Bank Act of
                1945 (12 U.S.C. 635 et seq.).

    TITLE I--STRENGTHENING OF INTERNATIONAL SANCTIONS AGAINST SYRIA

SEC. 101. DECLARATIONS OF POLICY.

    Congress makes the following declarations of policy:
            (1) The actions of the Government of the Syrian Arab
        Republic, including its support for terrorism, its development
        of long-range missiles and weapons of mass destruction programs
        and capabilities, its continued occupation of the Lebanese
        Republic in violation of its international obligations, its
        support for, and facilitation of, all terrorist activities
        inside of Iraq, and its massive, systematic, and extraordinary
        violations of human rights of both the Syrian and Lebanese
        people, are a threat to the national security interests of the
        United States and international peace.
            (2) The policy of the United States shall be to deny Syria
        the ability to carry out the following:
                    (A) To finance, provide safe-haven, or otherwise
                support terrorist organizations.
                    (B) To develop biological, chemical, or nuclear
                weapons and long-range ballistic missiles.
                    (C) To continue to occupy and otherwise interfere
                in the affairs of the Government of Lebanon in
                contravention of United Nations Security Council
                Resolutions 425 (1978), 426 (1978), 520 (1982), and
                1559 (2004), and other pertinent obligations.
                    (D) To continue to oppress the people of Syria.
            (3) The President should advocate for, and should instruct
        the United States Permanent Representative to the United
        Nations to propose and seek within the United Nations Security
        Council, a mandatory international embargo against the
        Government of Syria, pursuant to Article 41 of the Charter of
        the United Nations.
            (4) Any effort by a country that is a recipient of United
        States foreign assistance to facilitate, directly or
        indirectly, the development of Syria's nuclear, biological, or
        chemical weapons capabilities, long-range ballistic missile
        development programs, or to help make operational any nuclear
        facility in Syria will have a detrimental impact on United
        States assistance to such country.

SEC. 102. CODIFICATION OF EXISTING SANCTIONS.

    United States sanctions, controls, and regulations relating to
Syria and persons who are determined to be facilitating the Government
of Syria, as in effect on the date of the enactment of this Act, shall
remain in effect until the President certifies to the appropriate
congressional committees that--
            (1) a government exists in Syria that--
                    (A) has ceased any and all support for terrorism;
                    (B) has permanently dismantled Syria's biological,
                chemical, or nuclear weapons programs and has committed
                to combat the proliferation of such weapons;
                    (C) has withdrawn from Lebanon and respects the
                boundaries and sovereignty of all neighboring
                countries; and
                    (D) upholds and defends human rights and civil
                liberties; and
            (2) sovereignty has been restored to Lebanon and there
        exists a freely-elected, internationally recognized democratic
        government in Lebanon.

SEC. 103. SANCTIONS AGAINST CERTAIN PERSONS.

    (a) Prohibition.--If any person knowingly transfers or retransfers
goods or technology so as to contribute to the efforts by Syria to
acquire or develop destabilizing numbers and types of advanced
conventional weapons, or to acquire, develop, produce, or stockpile
biological, chemical, or nuclear weapons and long-range ballistic
missiles, then the sanctions described in subsection (b) shall be
imposed.
    (b) Sanctions.--The sanctions to be imposed pursuant to subsection
(a) are as follows:
            (1) Procurement sanction.--The United States Government
        shall not procure, or enter into any contract for the
        procurement of, any goods or services from the sanctioned
        person.
            (2) Export sanction.--The United States Government shall
        not issue any license for any export by or to the sanctioned
        person.
            (3) Import sanction.--The President shall ban the
        importation of any article that is a product of the sanctioned
        person.

SEC. 104. SANCTIONS AGAINST CERTAIN FOREIGN COUNTRIES.

    (a) Prohibition.--If the President determines that the government
of any foreign country knowingly transfers or retransfers goods or
technology, or provides assistance, so as to contribute to the efforts
by Syria to acquire or develop destabilizing numbers and types of
advanced conventional weapons, or to acquire, develop, produce, or
stockpile biological, chemical, or nuclear weapons and long-range
ballistic missiles, then two or more of the sanctions described in
subsection (b), and the sanctions described in subsection (c), shall be
imposed.
    (b) Sanctions.--The sanctions referred to in subsection (a) are as
follows:
            (1) Suspension of united states assistance.--The United
        States Government shall suspend United States assistance to the
        sanctioned country.
            (2) Export sanction.--The United States Government shall
        not issue any license for any export by or to the sanctioned
        country.
            (3) Import sanction.--The President shall ban the
        importation of any article that is a product of the sanctioned
        country.
            (4) International financial institution assistance.--The
        Secretary of the Treasury shall instruct the United States
        Executive Director at each international financial institution
        (as defined in section 1701(c)(2) of the International
        Financial Institutions Act) to oppose and vote against the
        extension by such institution of any financial or technical
        assistance to the sanctioned country.
            (5) Suspension of codevelopment or coproduction
        agreements.--The United States shall suspend compliance with
        its obligations under any memorandum of understanding with the
        sanctioned country for the codevelopment or coproduction of any
        item on the United States Munitions List (established under
        section 38 of the Arms Export Control Act (22 U.S.C. 2778)),
        including any obligation for implementation of the memorandum
        of understanding through the sale to the sanctioned country of
        technical data or assistance or the licensing for export to the
        sanctioned country of any component part.
            (6) United states munitions list.--No item on the United
        States Munitions List (established pursuant to section 38 of
        the Arms Export Control Act) may be exported to the sanctioned
        country.
    (c) Suspension of Military and Dual-Use Technical Exchange
Agreements.--The United States shall suspend compliance with its
obligations under any technical exchange agreement involving military
and dual-use technology between the United States and the sanctioned
country that does not directly contribute to the security of the United
States, and no military or dual-use technology may be exported from the
United States to the sanctioned country pursuant to that agreement
during that period.

SEC. 105. DIPLOMATIC EFFORTS.

    (a) Bilateral Efforts.--It is the sense of Congress that the
Secretary of State should ensure that United States diplomatic
personnel abroad understand and, in their contacts with foreign
officials, are communicating the reasons for United States policy and
sanctions against the Government of Syria, and are urging foreign
governments to cooperate more effectively with the Government of the
United States.
    (b) United Nations System.--The President shall direct the United
States Permanent Representative to the United Nations, United Nations
organizations and entities, and United Nations affiliated agencies and
bodies, to continue to use the voice and vote of the United States to
oppose Syria's membership and candidacy for leadership posts in such
institutions, and engage in diplomatic efforts to secure multilateral
support for such efforts.
    (c) United Nations Commission on Human Rights.--The President shall
take the necessary steps to secure support for a resolution at the
United Nations Commission on Human Rights holding the the Government of
Syria accountable for its systematic violations of human rights of
Syrian and Lebanese citizens and calling for the appointment of a
United Nations Special Rapporteur to investigate these human rights
violations.
    (d) International Financial Institutions.--The President shall
instruct the United States Executive Director at each international
financial institution (as defined in section 1701(c)(2) of the
International Financial Institutions Act) to use the voice and vote of
the United States to oppose any loan or other assistance to Syria and
to oppose Syria's membership in the institution.
    (e) International Atomic Energy Agency.--The President shall
instruct the United States Permanent Representative to the
International Atomic Energy Agency (IAEA) to seek the adoption of a
resolution calling on Syria to declare all nuclear related facilities,
immediately and unconditionally suspend any activity which could be
used to develop nuclear weapons capability, and provide full access to
IAEA inspectors to its nuclear-related facilities.
    (f) United States and Regional Contact Groups.--The President shall
seek to establish contact groups with relevant countries in the Middle
East to provide forums in which United States officials who are
responsible for counter-proliferation efforts are able to meet, at
least twice each year, with their counterpart from such countries to--
            (1) discuss the global threats presented by Iranian nuclear
        proliferation and sponsorship of international terrorism; and
            (2) develop strategies to effectively address these
        threats.

SEC. 106. REPORT ON ASSISTANCE TO, AND COMMERCE WITH, SYRIA.

    (a) Report.--Not later than 90 days after the date of the enactment
of this Act, and on an annual basis thereafter, the President shall
transmit to the appropriate congressional committees a report on
assistance to, and commerce with, Syria by other foreign countries
during the preceding 12-month period.
    (b) Contents.--Each report required by subsection (a) shall, for
the period covered by the report, contain the following information, to
the extent such information is available:
            (1) A description of all bilateral assistance provided to
        Syria by other foreign countries, including humanitarian
        assistance.
            (2) A description of Syria's commerce with foreign
        countries, including an identification of Syria's trading
        partners and the extent of such trade.
            (3) A description of the joint ventures completed, or under
        consideration, by foreign nationals and business firms
        involving facilities in Syria, including an identification of
        the location of the facilities involved and a description of
        the terms of agreement of the joint ventures and the names of
        the parties that are involved.
            (4) A determination of the amount of debt of the Government
        of Syria that is owed to each foreign country, including--
                    (A) the amount of debt exchanged, forgiven, or
                reduced under the terms of each investment or operation
                in Syria involving foreign nationals; and
                    (B) the amount of debt owed to the foreign country
                that has been exchanged, forgiven, or reduced in return
                for a grant by the Syrian Government of an equity
                interest in a property, investment, or operation of the
                Syrian Government or of a Syrian national.
            (5) A description of the steps taken to assure that raw
        materials and semifinished or finished goods produced by
        facilities in Syria involving foreign nationals do not enter
        the United States market, either directly or through third
        countries or parties.
            (6) An identification of countries and entities that
        provide, or have provided, arms or military supplies from Syria
        or that otherwise have entered into agreements with Syria that
        could have a military application, including--
                    (A) a description of the military supplies,
                equipment, or other material sold, bartered, or
                exchanged between Syria and such countries;
                    (B) a listing of the goods, services, credits, or
                other consideration received by Syria in exchange for
                military supplies, equipment, or material; and
                    (C) the terms or conditions of any such agreement.
    (c) Form.--The report submitted under subsection (a) shall be in
unclassified form but may include a classified annex.

TITLE II--ASSISTANCE TO SUPPORT DEMOCRACY IN SYRIA AND SOVEREIGNTY AND
                          DEMOCRACY IN LEBANON

SEC. 201. DECLARATIONS OF POLICY.

    (a) Syria.--It shall be the policy of the United States to support
independent human rights and pro-democracy forces in Syria to promote
the emergence of a democratic government that--
            (1) will denounce and combat terrorism;
            (2) will dismantle its biological, chemical, and nuclear
        weapons programs and commit to combat the proliferation of such
        weapons;
            (3) will respect the boundaries and sovereignty of its
        neighbors and live in peace and security with all the countries
        in the region; and
            (4) will uphold and defend the human rights and civil
        liberties of its citizens.
    (b) Lebanon.--It shall be the policy of the United States to
initiate efforts to restore Lebanese sovereignty, including the
immediate and unconditional withdrawal of all Syrian personnel from
Lebanon, and to support Lebanese civil society and pro-democracy forces
in restoring a freely-elected, internationally recognized democratic
government in Lebanon.

SEC. 202. ASSISTANCE TO SUPPORT A TRANSITION TO DEMOCRACY IN SYRIA AND
              RESTORATION OF SOVEREIGN DEMOCRATIC GOVERNANCE IN
              LEBANON.

    (a) Authorization.--Notwithstanding any other provision of law, the
President is authorized to provide assistance and other support for
individuals and independent nongovernmental organizations to support a
transition to a freely-elected, internationally recognized democratic
government in Syria and the restoration of sovereign, democratic rule
in Lebanon.
    (b) Activities Supported.--Assistance provided under subsection (a)
shall, to the maximum extent practicable, be used to carry out the
following activities:
            (1) Democracy-building and civil society efforts in Syria
        and Lebanon, including the provision of assistance to
        organizations certified by the President to be independent
        democratic organizations, victims of political repression and
        their families, and prisoners of conscience and their families.
            (2) Radio and television broadcasting to Syria and Lebanon
        to support democracy-building and civil society efforts in
        Syria and Lebanon.
    (c) Authorization of Appropriations.--There are authorized to be
appropriated to the President to carry out this section such sums as
may be necessary for fiscal year 2006 and each subsequent fiscal year.

Summary: Lebanon and Syria Liberation Act - States that US sanctions, controls, and regulations relating to Syria shall remain in effect until the President certifies that: (1) Syria has ceased support for terrorism, has dismantled biological, chemical, or nuclear weapons programs and has committed to combat their proliferation, has withdrawn from Lebanon and respects the boundaries and sovereignty of all neighboring countries, and upholds human rights and civil liberties. And (2) sovereignty has been restored to Lebanon. Imposes specified trade, assistance, and military sanctions, as appropriate, on persons or countries that transfer goods or technology so as to contribute to Syria's biological, chemical, nuclear, or advanced conventional weapons programs. Sets forth diplomatic measures intended to achieve such nonproliferation. Directs the President to provide assistance to support a democratic transition in Syria and the restoration of sovereign, democratic rule in Lebanon. Authorizes appropriations.

To strengthen sanctions against the Government of Syria, to establish a program to support a transition to a democratically elected government in Syria and the restoration of sovereignty and democratic rule in Lebanon, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicaid Mammography Coverage Act of
1993''.

SEC. 2. COVERAGE OF SCREENING MAMMOGRAPHY UNDER MEDICAID.

    (a) In General.--Section 1905(a) of the Social Security Act (42
U.S.C. 1396d(a)), as amended by the Omnibus Budget Reconciliation Act
of 1990, is amended--
            (1) by striking ``and'' at the end of paragraph (21);
            (2) in paragraph (24), by striking the comma at the end and
        inserting a semicolon;
            (3) by redesignating paragraphs (22), (23), and (24) as
        paragraphs (21), (22), and (23), respectively, and by
        transferring and inserting paragraph (25) after paragraph (23),
        as so redesignated; and
            (4) by inserting after paragraph (23) the following new
        paragraph:
            ``(24) screening mammography (as defined in subsection
        (t)(1)) that meets the quality standards established under
        section 1834(c)(3), to the extent consistent with the frequency
        permitted under subsection (t)(2); and''.
    (b) Frequency of Coverage.--Section 1905 of the Social Security Act
(42 U.S.C. 1396d) is amended by adding at the end the following new
subsection:
    ``(t) Coverage of Screening Mammography.--
            ``(1) Definition.--The term `screening mammography' means a
        radiologic procedure provided to a woman for the purpose of
        early detection of breast cancer and includes a physician's
        interpretation of the results of the procedure.
            ``(2) Frequency covered.--
                    ``(A) In general.--Subject to revision by the
                Secretary under subparagraph (B)--
                            ``(i) Medical assistance is not required to
                        be made under this title for screening
                        mammography performed on a woman under 35 years
                        of age.
                            ``(ii) Medical assistance is available
                        under this title for only 1 screening
                        mammography performed on a woman over 34 years
                        of age, but under 40 years of age.
                            ``(iii) In the case of a woman over 39
                        years of age, but under 50 years of age, who--
                                    ``(I) is at a high risk of
                                developing breast cancer (as determined
                                pursuant to factors identified by the
                                Secretary), medical assistance is not
                                required to be made available under
                                this title for a screening mammography
                                performed within 11 months of a
                                previous screening mammography, or
                                    ``(II) is not at a high risk of
                                developing breast cancer, medical
                                assistance is not required to be made
                                available under this title for a
                                screening mammography performed within
                                23 months of a previous screening
                                mammography.
                            ``(iv) In the case of a woman over 49 years
                        of age, medical assistance is not required to
                        be made available under this title for
                        screening mammography performed within 11
                        months of a previous screening mammography.
                    ``(B) Revision of frequency.--
                            ``(i) Review.--The Secretary, in
                        consultation with the Director of the National
                        Cancer Institute, shall review periodically
                        appropriate frequency for performing screening
                        mammography, based on age and such other
                        factors as the Secretary believes to be
                        pertinent.
                            ``(ii) Revision of frequency.--The
                        Secretary, taking into consideration the review
                        made under clause (i), may revise from time to
                        time the frequency with which medical
                        assistance is required to be made available
                        under this title, but no such revision shall
                        apply to screening mammography performed before
                        January 1, 1993.''.
    (c) Conforming Amendments.--(1) Section 1902(a)(10(A) of such Act
(42 U.S.C. 1396a(a)(10)(A)) is amended by striking ``(17) and (21)''
and inserting ``(17), (21) and (24)''.
    (2) Section 1902(a)(10)(C)(iv) (42 U.S.C. 1396a(a)(10)(C)(iv)) is
amended--
            (A) by striking ``(5) and (17)'' and inserting ``(5), (17),
        and (24)''; and
            (B) by striking ``through (21)'' and inserting ``through
        (24)''.
    (3) Section 1902(j) (42 U.S.C. 1396a(j)) is amended by striking
``through (22)'' and inserting ``through (24)''.
    (4) Sections 1916(a)(2)(D) and 1916(b)(2)(D) (42 U.S.C.
1396o(a)(2)(D), 1396o(b)(2)(D)) are each amended by inserting
``services described in section 1905(a)(24)'' before ``family planning
services''.
    (d) Effective Date.--(1) Except as provided in paragraph (2), the
amendments made by subsections (a), (b), and (c) shall apply to
screening mammography performed on or after January 1, 1994, without
regard to whether or not final regulations to carry out such amendments
have been promulgated by such date.
    (2) In the case of a State plan for medical assistance under title
XIX of the Social Security Act which the Secretary of Health and Human
Services determines requires State legislation (other than legislation
appropriating funds) in order for the plan to meet the additional
requirement imposed by the amendments made by this section, the State
plan shall not be regarded as failing to comply with the requirements
of such title solely on the basis of its failure to meet this
additional requirement before the first day of the first calendar
quarter beginning after the close of the first regular session of the
State legislature that begins after the date of the enactment of this
Act. For purposes of the previous sentence, in the case of a State that
has a 2-year legislative session, each year of such session shall be
deemed to be a separate regular session of the State legislature.

Summary: Medicaid Mammography Coverage Act of 1993 - Amends title XIX (Medicaid) of the Social Security Act to provide Medicaid coverage of screening mammographies for women age 35 and older. Varies the permissible frequency of such covered tests on the basis of a woman's age and her risk of developing breast cancer. Directs the Secretary to periodically review and revise permissible frequencies of such tests.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Uterine Fibroid Research and
Education Act of 2003''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) The development of uterine fibroids is a common and
        significant health problem, affecting women of all ages, racial
        backgrounds, and socioeconomic levels.
            (2) It has been estimated that between 20 and 30 percent of
        women of reproductive age have uterine fibroids, though not all
        have been diagnosed. Studies indicate the prevalence could be
        much higher.
            (3) Symptomatic uterine fibroids can cause heavy bleeding,
        pain, and reproductive problems, including infertility. There
        is no known cause of uterine fibroids.
            (4) Uterine fibroids are the most common indication for
        hysterectomy, accounting for approximately one-third of
        hysterectomies, or 200,000 procedures annually.
            (5) African American women are 2 to 3 times more likely to
        develop uterine fibroids than women of other racial groups.
            (6) The estimated annual charges for inpatient care for
        uterine fibroids totaled more than $2,000,000,000 in 1997.
            (7) The Agency for Healthcare Research and Quality found a
        ``remarkable lack of high quality evidence supporting the
        effectiveness of most interventions for symptomatic fibroids''.

SEC. 3. RESEARCH WITH RESPECT TO UTERINE FIBROIDS.

    (a) In General.--The Director of the National Institutes of Health
(in this section referred to as the ``Director of NIH'') shall expand,
intensify, and coordinate programs for the conduct and support of
research with respect to uterine fibroids.
    (b) Administration.--
            (1) In general.--The Director of NIH shall carry out this
        section through the appropriate institutes, offices, and
        centers, including the National Institute of Child Health and
        Human Development, the National Institute of Environmental
        Health Sciences, the Office of Research on Women's Health, the
        National Center on Minority Health and Health Disparities, and
        any other agencies that the Director of NIH determines to be
        appropriate.
            (2) Coordination of activities.--The Office of Research on
        Women's Health shall coordinate activities under paragraph (1)
        among the institutes, offices, and centers of the National
        Institutes of Health.
    (c) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $10,000,000
for each of the fiscal years 2004 through 2008.

SEC. 4. INFORMATION AND EDUCATION WITH RESPECT TO UTERINE FIBROIDS.

    (a) Uterine Fibroids Public Education Program.--
            (1) In general.--The Secretary of Health and Human Services
        (referred to in this section as the ``Secretary''), acting
        through the Director of the Centers for Disease Control and
        Prevention, shall develop and disseminate to the public
        information regarding uterine fibroids, including information
        on--
                    (A) the incidence and prevalence of uterine
                fibroids;
                    (B) the elevated risk for minority women; and
                    (C) the availability, as medically appropriate, of
                a range of treatment options for symptomatic uterine
                fibroids.
            (2) Dissemination.--The Secretary may disseminate
        information under paragraph (1) directly, or through
        arrangements with nonprofit organizations, consumer groups,
        institutions of higher education (as defined in section 101 of
        the Higher Education Act of 1965 (20 U.S.C. 1001)), Federal,
        State, or local agencies, or the media.
            (3) Authorization of appropriations.--For the purpose of
        carrying out this subsection, there are authorized to be
        appropriated such sums as may be necessary for each of the
        fiscal years 2004 through 2008.
    (b) Uterine Fibroids Information Program for Health Care
Providers.--
            (1) In general.--The Secretary, acting through the
        Administrator of the Health Resources and Services
        Administration, shall develop and disseminate to health care
        providers information on uterine fibroids, including
        information on the elevated risk for minority women and the
        range of available options for the treatment of symptomatic
        uterine fibroids.
            (2) Authorization of appropriations.--For the purpose of
        carrying out this subsection, there are authorized to be
        appropriated such sums as may be necessary for each of the
        fiscal years 2004 through 2008.
    (c) Definition.--For purposes of this section, the term
``minority'', with respect to women, means women who are members of
racial or ethnic minority groups within the meaning of section 1707 of
the Public Health Service Act (42 U.S.C. 300u-6).

Summary: Uterine Fibroid Research and Education Act of 2003 - Directs the Director of the National Institutes of Health (NIH) to expand, intensify, and coordinate programs for the conduct and support of research with respect to uterine fibroids. Directs the Secretary of Health and Human Services to develop and disseminate to the public information regarding uterine fibroids, including on: (1) the elevated risk for minority women. And (2) the availability of a range of treatment options. Directs the Secretary, acting through the Administrator of the Health Resources and Services Administration, to develop and disseminate to health care providers information on uterine fibroids, including on: (1) the elevated risk for minority women, and (2) and treatment options.

To provide for uterine fibroid research and education, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Dietary Supplement Full
Implementation and Enforcement Act of 2010''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Each year, more than 150,000,000 Americans regularly
        consume dietary supplements to maintain and improve their
        health.
            (2) Consumer expenditures on dietary supplements exceeded
        $25,000,000,000 in 2008.
            (3) Given the growing awareness of the importance of
        prevention and wellness in the health care system of the United
        States, it is vital that laws governing the safety of, and
        education about, dietary supplements be fully implemented and
        enforced.
            (4) In 1994, Congress approved, and the President signed
        into law, the Dietary Supplement Health and Education Act of
        1994 (Public Law 103-417) (referred to in this Act as
        ``DSHEA''). DSHEA balanced the importance of continuing
        consumer access to vitamins, minerals, and other dietary
        supplements, promoting scientific research on the benefits and
        risks of dietary supplements, and fostering public education on
        the benefits and risks of supplement use with the need for
        regulatory safeguards to protect consumer health, including a
        new standard for safety, penalties for mislabeled or
        adulterated dietary supplements, rules to ensure scientific
        substantiation of the claims made regarding dietary
        supplements, and a notification requirement to the Food and
        Drug Administration before dietary supplements that contain
        certain new dietary ingredients may be marketed.
            (5) DSHEA requires that claims made on dietary supplement
        labels, packaging, and accompanying material be truthful, non-
        misleading, and substantiated. Manufacturers are prohibited
        from making claims that products are intended to diagnose,
        treat, mitigate, cure, or prevent a disease.
            (6) DSHEA requires that dietary supplements comply with
        good manufacturing practice (referred to in this section as
        ``GMP'') requirements, and authorizes the Food and Drug
        Administration to establish such requirements.
            (7) In 2007, after many years of delay, the Food and Drug
        Administration published regulations detailing the GMP
        requirements for dietary supplements, including requirements
        for identity, purity, strength, sanitary conditions, and
        recordkeeping. The Food and Drug Administration began to
        enforce those requirements in 2008.
            (8) DSHEA requires that, before marketing a dietary
        supplement containing certain new dietary ingredients, the
        manufacturer or distributor must submit notice to the Food and
        Drug Administration that includes information showing that the
        dietary supplement will reasonably be expected to be safe.
        According to the Food and Drug Administration, the Food and
        Drug Administration has raised objections to more than 70
        percent of all new dietary ingredient notifications submitted
        to the agency.
            (9) The Food and Drug Administration has successfully used
        the adulteration provisions of DSHEA to remove from the
        marketplace dietary supplements that present an unreasonable
        risk of injury or illness.
            (10) In 2002, Congress passed the Public Health Security
        and Bioterrorism Preparedness and Response Act (Public Law 107-
        188). This law requires any facility engaged in manufacturing,
        processing, packing, or holding food for consumption in the
        United States, including dietary supplements, to be registered
        with the Food and Drug Administration.
            (11) In 2006, Congress supplemented DSHEA by approving the
        Dietary Supplement and Nonprescription Drug Consumer Protection
        Act (Public Law 109-462). This law requires dietary supplement
        manufacturers, packers, and distributors to report promptly to
        the Food and Drug Administration any reports the manufacturer
        or other responsible person receives of serious adverse events
        associated with the use of the products of such manufacturer or
        other responsible person. Information the Food and Drug
        Administration receives under this reporting requirement may
        help the agency detect possible safety problems related to
        dietary supplement products or ingredients.
            (12) DSHEA created the Office of Dietary Supplements within
        the National Institutes of Health to expand research and
        consumer information about the health effects of dietary
        supplements. The Office of Dietary Supplements has greatly
        expanded the number of scientific studies of dietary
        supplements and the availability of reliable information to
        consumers.
            (13) While the Food and Drug Administration has taken some
        important steps to implement and enforce DSHEA and the other
        laws governing the regulation of dietary supplements, the
        agency has not fully implemented and enforced DSHEA and the
        other laws governing the regulation of dietary supplements.
            (14) Both the public and regulated industry would benefit
        from more guidance from the Food and Drug Administration on the
        procedures and definitions concerning the regulation of new
        dietary ingredients under section 413 of the Federal Food,
        Drug, and Cosmetic Act (21 U.S.C. 350b).
            (15) If the Food and Drug Administration determines that a
        product labeled as a dietary supplement includes an anabolic
        steroid or an analogue of an anabolic steroid, the Food and
        Drug Administration does not systematically notify the Drug
        Enforcement Administration of that determination.
            (16) The Food and Drug Administration needs adequate
        resources to implement and enforce DSHEA and other laws
        governing the regulation of dietary supplements appropriately.
        Congress has appropriated additional funds over the last
        several years to implement and enforce DSHEA, reaching more
        than $14,000,000 for fiscal year 2009.
            (17) According to the Food and Drug Administration, full
        implementation of DSHEA and the other laws governing the
        regulation of dietary supplements would require substantial
        additional resources. In 2002, the Food and Drug Administration
        reported to Congress in writing that the agency would need
        between $24,000,000 and $65,000,000 per year to fully implement
        DSHEA.

SEC. 3. SENSE OF CONGRESS.

    It is the sense of Congress that:
            (1) The Food and Drug Administration should increase
        efforts to implement DSHEA more fully and effectively, by--
                    (A) providing Congress with a professional judgment
                estimate of the annual costs during the 5-year period
                beginning on the date of enactment of this Act to fully
                implement and enforce DSHEA and other dietary
                supplement laws and regulations under the jurisdiction
                of the Food and Drug Administration;
                    (B) conducting inspections, using appropriately
                trained inspection personnel, of all facilities in
                which a dietary supplement is manufactured, processed,
                packed, or held to ensure compliance with the new
                dietary supplement good manufacturing practices
                regulations;
                    (C) using the authority under DSHEA to protect the
                public from unsafe dietary supplement products and
                ingredients and to ensure that claims made are
                truthful, non-misleading, and substantiated, with
                highest regulatory priority given to cases of clear
                violations of the law (including the intentional
                adulteration and spiking of products);
                    (D) implementing the recommendations contained in
                the January 2009 report of the Government
                Accountability Office, entitled, ``Dietary Supplements:
                FDA Should Take Further Actions To Improve Oversight
                and Consumer Understanding'', (GAO 09-250) that the
                Food and Drug Administration--
                            (i) require all dietary supplement
                        manufacturers, packers, and distributors to
                        identify themselves specifically as such under
                        existing registration requirements and to
                        update such information annually;
                            (ii) promptly issue guidance to clarify
                        when a dietary supplement ingredient is a new
                        dietary ingredient, the evidence needed to
                        document the safety of new dietary ingredients,
                        and appropriate methods for establishing the
                        identity of a new dietary ingredient; and
                            (iii) coordinate with stakeholder groups
                        involved in consumer outreach to identify,
                        implement, and evaluate the effectiveness of
                        additional mechanisms for educating consumers
                        about the safety, efficacy, and labeling of
                        dietary supplements; and
                    (E) notifying the Drug Enforcement Administration
                if the Food and Drug Administration determines that the
                information in a new dietary ingredient notification
                submitted under section 413 of the Federal Food, Drug,
                and Cosmetic Act (21 U.S.C. 350b) is inadequate to
                establish that the new dietary ingredient will
                reasonably be expected to be safe, because the dietary
                supplement may contain an anabolic steroid or an
                analogue of an anabolic steroid.
            (2) The manufacturers, packers, retailers, and distributors
        of dietary supplements and dietary supplement ingredients
        should increase efforts to--
                    (A) comply fully with all requirements of DSHEA and
                the Dietary Supplement and Nonprescription Drug
                Consumer Protection Act;
                    (B) cooperate fully and appropriately with the Food
                and Drug Administration in implementation and
                enforcement of Federal laws and regulations; and
                    (C) provide the Food and Drug Administration with
                appropriate input on known and suspected violations of
                such laws and regulations.

SEC. 4. AUTHORIZATION OF APPROPRIATIONS AND ALLOCATION OF RESOURCES.

    (a) Authorization of Appropriations.--There are authorized to be
appropriated to carry out the Dietary Supplement Health and Education
Act of 1994, the amendments made by such Act, and other provisions
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
that apply to dietary supplements, $30,000,000 for fiscal year 2011 and
such sums as may be necessary for each of fiscal years 2012 through
2014.
    (b) Allocation of Funds for Fiscal Year 2010.--From funds
appropriated to the Food and Drug Administration for fiscal year 2010
for the purpose of enhancing food safety, not less than $20,000,000
shall be expended to effectively and fully implement and enforce the
Dietary Supplement Health and Education Act of 1994, the amendments
made by such Act, and other provisions under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.) that apply to dietary
supplements.
    (c) Office of Dietary Supplements.--There are authorized to be
appropriated for expanded research and development of consumer
information on dietary supplements by the Office of Dietary Supplements
at the National Institutes of Health--
            (1) $40,000,000 for fiscal year 2010; and
            (2) such sums as may be necessary for each of the fiscal
        years 2011 through 2014.

SEC. 5. ANNUAL ACCOUNTABILITY REPORT ON THE REGULATION OF DIETARY
              SUPPLEMENTS.

    (a) In General.--Not later than January 31, 2011, and annually
thereafter, the Secretary of Health and Human Services shall submit a
report to Congress on the implementation and enforcement of the Dietary
Supplement Health and Education Act of 1994 and the amendments made by
such Act.
    (b) Contents.--The report under subsection (a) shall include the
following:
            (1) The total funding and number of full-time equivalent
        personnel in the Food and Drug Administration dedicated to
        dietary supplement regulation during the prior fiscal year.
            (2) The total funding and number of full-time equivalent
        personnel in the Food and Drug Administration dedicated to
        administering adverse event reporting systems, as such systems
        relate to dietary supplement regulation, during the prior
        fiscal year.
            (3) The total funding and number of full-time equivalent
        personnel in the Food and Drug Administration dedicated to
        enforcement of dietary supplement labeling and claims
        requirements during the prior fiscal year and a brief
        explanation of the activities of such personnel.
            (4) The total funding and number of full-time equivalent
        personnel in the Food and Drug Administration dedicated to the
        review and enforcement of good manufacturing practice
        requirements with respect to dietary supplements during the
        prior fiscal year.
            (5) The number of inspections at which the Food and Drug
        Administration evaluated or reviewed the compliance of a
        manufacturer with good manufacturing practices for dietary
        supplements during the prior fiscal year, and the number of
        times the Food and Drug Administration issued a warning letter
        because it determined that such manufacturer was not in
        compliance with some aspect of such requirements.
            (6) The number of new dietary ingredient notification
        reviews that the Food and Drug Administration performed during
        the prior fiscal year and the number of times the Food and Drug
        Administration objected to the marketing of the dietary
        supplement described in such notification reviews.
            (7) The number of times the Food and Drug Administration
        issued a warning letter or initiated an enforcement action
        against a manufacturer or distributor for failure to file a new
        dietary ingredient notification as required under section 413
        of the Federal Food, Drug, and Cosmetic Act.
            (8) A brief summary and explanation of all enforcement
        actions taken by the Food and Drug Administration and the
        Department of Health and Human Services related to dietary
        supplements during the prior fiscal year, including the number
        and type of actions.
            (9) The number of times the Food and Drug Administration
        requested substantiation of dietary supplement claims from a
        manufacturer during the prior fiscal year, the number of times
        a manufacturer refused to provide such information, and the
        response of the agency in such situations.
            (10) The number of dietary supplement claims determined by
        the Food and Drug Administration during the prior fiscal year
        to be false, misleading, or not substantiated, and a
        description of the follow-up action taken by the agency in such
        instances.
            (11) The research and consumer education activities
        supported by the Office of Dietary Supplements of the National
        Institutes of Health during the prior fiscal year.
            (12) Any recommendations for administrative or legislative
        actions to improve the regulation of dietary supplements.
            (13) Any other information regarding the regulation of
        dietary supplements determined appropriate by the Secretary of
        Health and Human Services or the Commissioner of Food and
        Drugs.

SEC. 6. NEW DIETARY INGREDIENTS.

    (a) Guidelines for Introducing New Dietary Ingredients.--Section
413 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b) is
amended--
            (1) by redesignating subsection (c) as subsection (e); and
            (2) by inserting after subsection (b) the following:
    ``(c) Guidelines.--Not later than 180 days after the date of
enactment of the Dietary Supplement Full Implementation and Enforcement
Act of 2010, the Secretary shall publish guidance that clarifies when a
dietary supplement ingredient is a new dietary ingredient, when the
manufacturer or distributor of a dietary ingredient or dietary
supplement should provide the Secretary with information as described
in subsection (a)(2), the evidence needed to document the safety of new
dietary ingredients, and appropriate methods for establishing the
identity of a new dietary ingredient.
    ``(d) Notification to DEA.--
            ``(1) In general.--If the Secretary determines that the
        information in a new dietary ingredient notification submitted
        under this section for an article purported to be a new dietary
        ingredient is inadequate to establish that a dietary supplement
        containing such article will reasonably be expected to be safe
        because the article may be, or may contain, an anabolic steroid
        or an analogue of an anabolic steroid, the Secretary shall
        notify the Drug Enforcement Administration of such
        determination. Such notification by the Secretary shall
        include, at a minimum, the name of the product or article, the
        name of the person or persons who marketed the product or made
        the submission of information regarding the article to the
        Secretary under this section, and any contact information for
        such person or persons that the Secretary has.
            ``(2) Definitions.--For purposes of this subsection--
                    ``(A) the term `anabolic steroid' has the meaning
                given such term in section 102(41) of the Controlled
                Substances Act; and
                    ``(B) the term `analogue of an anabolic steroid'
                means a substance whose chemical structure is
                substantially similar to the chemical structure of an
                anabolic steroid.''.

Summary: Dietary Supplement Full Implementation and Enforcement Act of 2010 - Authorizes appropriations for FY2011-FY2014 to carry out the Dietary Supplement Health and Education Act of 1994 (DSHEA) and other provisions under the Federal Food, Drug, and Cosmetic Act (FFDCA) that apply to dietary supplements. Requires the allocation of funds appropriated to the Food and Drug Administration (FDA) for FY2010 for the purpose of enhancing food safety to be expended to effectively and fully implement and enforce DSHEA and other FFDCA provisions that apply to dietary supplements. Authorizes appropriations for FY2010-FY2014 for expanded research and development of consumer information on dietary supplements by the Office of Dietary Supplements at the National Institutes of Health (NIH). Requires the Secretary of Health and Human Services (HHS) to report to Congress annually on the implementation and enforcement of DSHEA and its amendments. Amends the FFDCA to require the Secretary to publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with safety information, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identity of a new dietary ingredient. Requires the Secretary to notify the Drug Enforcement Agency (DEA) if information in a new dietary ingredient notification is inadequate to establish that a dietary supplement containing such ingredient will reasonably be expected to be safe because the ingredient may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid.

A bill to ensure that the Dietary Supplement Health and Education Act of 1994 and other requirements for dietary supplements under the jurisdiction of the Food and Drug Administration are fully implemented and enforced, and for other purposes.


SECTION 1. SPECIAL IMMIGRANT STATUS FOR CERTAIN ALIENS, INCLUDING
              TRANSLATORS AND INTERPRETERS, SERVING WITH FEDERAL
              AGENCIES IN IRAQ AND AFGHANISTAN.

    (a) Increase in Numbers Admitted and Aliens Eligible.--
            (1) In general.--Section 1059 of the National Defense
        Authorization Act for Fiscal Year 2006 (8 U.S.C. 1101 note) is
        amended--
                    (A) in the heading, by striking ``as translators
                with united states armed forces'' and inserting ``with
                federal agencies in iraq and afghanistan'';
                    (B) in subsection (b)(1)--
                            (i) in subparagraph (B), by striking ``as a
                        translator'' and inserting ``, or under Chief
                        of Mission authority, as a translator,
                        interpreter, or other capacity'' ;
                            (ii) in subparagraph (C), by inserting
                        ``the Chief of Mission or'' after
                        ``recommendation from''; and
                            (iii) in subparagraph (D), by inserting
                        ``the Chief of Mission or'' after ``as
                        determined by''; and
                    (C) in subsection (c)(1), by inserting ``(or,
                beginning with fiscal year 2007, 500 or such greater
                number as the Secretary of Homeland Security determines
                is warranted by the circumstances)'' after ``50''.
            (2) Review.--If the circumstances warrant, the Secretary of
        Homeland Security, in consultation with the Secretary of State,
        shall review the numerical limitation established under section
        1059(c)(1) of such Act, as amended by paragraph (1)(B), and may
        submit a report to Congress recommending an increase in such
        limitation.
            (3) Report.--The Secretary of Homeland Security shall
        submit to Congress a report whenever the Secretary increases,
        under subsection (c)(1) of section 1059 of such Act, as amended
        by paragraph (1)(B), the number of aliens provided special
        immigrant status under such section. Such report shall include
        an explanation of the circumstances warranting such increase.
    (b) Exclusion From Numerical Limitation.--Section 1059(c)(2) of
such Act is amended--
            (1) in the heading, by striking ``Counting against'' and
        inserting ``Exclusion from''; and
            (2) by inserting before the period at the end the
        following: ``but shall not be counted against any numerical
        limitation under section 201(d), 202(a), or 203(b)(4) of such
        Act (8 U.S.C. 1151(d), 1152(a), and 1153(b)(4))''.
    (c) Adjustment of Status.--Section 1059 of such Act is further
amended--
            (1) by redesignating subsection (d) as subsection (e); and
            (2) by inserting after subsection (c) the following:
    ``(d) Adjustment of Status.--Notwithstanding paragraphs (2), (7),
and (8) of section 245(c) of the Immigration and Nationality Act (8
U.S.C. 1255(c)), the Secretary of Homeland Security may adjust the
status of an alien to that of a lawful permanent resident under section
245(a) of such Act if the alien--
            ``(1) was paroled or admitted as a nonimmigrant into the
        United States; and
            ``(2) is otherwise eligible for special immigrant status
        under this section and under the Immigration and Nationality
        Act.''.
    (d) Refugee Assistance Eligibility.--Section 1059 of such Act, as
amended by subsection (c), is further amended--
            (1) by redesignating (e) as subsection (f); and
            (2) by inserting after subsection (d) the following:
    ``(e) Eligibility for Refugee Assistance.--Any alien provided
special immigrant status under this section shall be eligible for
benefits under chapter 2 of title IV of the Immigration and Nationality
Act to the same extent as individuals admitted (or awaiting admission)
to the United States under section 207 of such Act are eligible for
benefits under such chapter.''.
    (e) Sunset Provision.--Section 1059 of such Act, as amended by
subsections (c) and (d), is further amended by adding at the end the
following:
    ``(g) Sunset Provision.--
            ``(1) In general.--This section is repealed on the date
        that is 3 years after the date of the enactment of this
        subsection.
            ``(2) Applicability.--Notwithstanding paragraph (1), the
        Secretary of Homeland Security may provide an alien with the
        status of a special immigrant under this section if--
                    ``(A) the alien's petition for such status was
                pending before the date described in paragraph (1); and
                    ``(B) the alien was eligible for such status at the
                time the petition was filed.''.

Summary: Amends the National Defense Authorization Act for Fiscal Year 2006 to authorize special immigrant status for certain Afghan or Iraqi translators or interpreters working with the US Armed Forces or federal agencies in Afghanistan and Iraq. Authorizes: (1) additional annual entrants, (2) adjustment to permanent resident status. And (3) eligibility for refugee assistance. Sunsets such special immigrant provisions.

To amend the National Defense Authorization Act for Fiscal Year 2006 to expand the provision of special immigrant status for certain aliens, including translators or interpreters, serving with Federal agencies in Iraq and Afghanistan.