In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

[Q]: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Make It In America Manufacturing 
Communities Act''.

SEC. 2. DEFINITIONS.

    In this Act:
            (1) Manufacturing community support program.--The term 
        ``Manufacturing Community Support Program'' means the program 
        established under section 3(a).
            (2) Participating agency.--The term ``participating 
        agency'' means a Federal agency that elects to participate in 
        the Manufacturing Community Support Program.
            (3) Participating program.--The term ``participating 
        program'' means a program identified by a participating agency 
        under section 3(c)(1)(C).
            (4) Secretary.--The term ``Secretary'' means the Secretary 
        of Commerce.

SEC. 3. PROGRAM TO DESIGNATE AND SUPPORT MANUFACTURING COMMUNITIES.

    (a) Program Authorized.--The Secretary shall establish a program to 
improve the competitiveness of United States manufacturing--
            (1) by designating consortiums as manufacturing communities 
        under subsection (b); and
            (2) by supporting manufacturing communities, as so 
        designated, under subsection (c).
    (b) Designation of Manufacturing Communities.--
            (1) In general.--Except as provided in paragraph (7), for 
        purposes of the Manufacturing Community Support Program, the 
        Secretary shall designate eligible consortiums as manufacturing 
        communities through a competitive process.
            (2) Eligible consortiums.--
                    (A) In general.--An eligible consortium is a 
                consortium that--
                            (i) represents a region defined by the 
                        consortium in accordance with subparagraph (B);
                            (ii) includes at least one--
                                    (I) institution of higher 
                                education;
                                    (II) a private sector entity; and
                                    (III) a government entity;
                            (iii) may include one or more--
                                    (I) private sector partners;
                                    (II) institutions of higher 
                                education;
                                    (III) government entities;
                                    (IV) economic development and other 
                                community and labor groups;
                                    (V) financial institutions; or
                                    (VI) utilities;
                            (iv) has, as a lead applicant--
                                    (I) a district organization (as 
                                defined in section 300.3 of title 13, 
                                Code of Federal Regulations, or 
                                successor regulation);
                                    (II) an Indian tribe (as defined in 
                                section 4 of the Indian Self-
                                Determination and Education Assistance 
                                Act (25 U.S.C. 450b)) or a consortium 
                                of Indian tribes;
                                    (III) a State or a political 
                                subdivision of a State, including a 
                                special purpose unit of a State or 
                                local government engaged in economic or 
                                infrastructure development activities, 
                                or a consortium of political 
                                subdivisions;
                                    (IV) an institution of higher 
                                education or a consortium of 
                                institutions of higher education; or
                                    (V) a public or private nonprofit 
                                organization or association that has an 
                                application that is supported by a 
                                State, a political subdivision of a 
                                State, or a native community.
                    (B) Regions.--Subject to approval by the Secretary, 
                a consortium may define the region that it represents 
                if the region--
                            (i) is large enough to contain critical 
                        elements of the key technologies or supply 
                        chain prioritized by the consortium; and
                            (ii) is small enough to enable close 
                        collaboration among members of the consortium.
            (3) Duration.--Each designation under paragraph (1) shall 
        be for a period of two years.
            (4) Renewal.--
                    (A) In general.--Upon receipt of an application 
                submitted under subparagraph (B), the Secretary may 
                renew a designation made under paragraph (1) for up to 
                two additional two-year periods. Any designation as a 
                manufacturing community or renewal of such designation 
                that is in effect before the date of the enactment of 
                this Act shall count toward the limit set forth in this 
                subparagraph.
                    (B) Application for renewal.--An eligible 
                consortium seeking a renewal under subparagraph (A) 
                shall submit an application to the Secretary at such 
                time, in such manner, and containing such information 
                as the Secretary may require.
                    (C) Modifications authorized.--The Secretary may 
                renew a designation under subparagraph (A) for an 
                eligible consortium that--
                            (i) has changed its composition, either by 
                        adding or removing members; or
                            (ii) as part of its application under 
                        subparagraph (B), submits a revision to the 
                        plan submitted under paragraph (5)(B)(iv) or 
                        the strategy submitted under paragraph 
                        (5)(B)(v).
                    (D) Evaluation for renewal.--In determining whether 
                to renew a designation of an eligible consortium under 
                paragraph (1), the Secretary shall assess the eligible 
                consortium based upon--
                            (i) the performance of the consortium 
                        against the terms of the consortium's most 
                        recent designation under paragraph (1) and any 
                        post-designation awards the consortium may have 
                        received;
                            (ii) the progress the consortium has made 
                        with respect to project-specific metrics the 
                        consortium proposed in the consortium's 
                        application for the most recent designation 
                        under paragraph (1), particularly with respect 
                        to those metrics that were designed to help 
                        communities track their own progress;
                            (iii) whether any changes to the 
                        composition of the eligible consortium or 
                        revisions to the plan or strategy described in 
                        subparagraph (C)(ii) would improve the 
                        competitiveness of United States manufacturing; 
                        and
                            (iv) such other criteria as the Secretary 
                        considers appropriate.
            (5) Application for designation.--
                    (A) In general.--An eligible consortium seeking a 
                designation under paragraph (1) shall submit an 
                application to the Secretary at such time and in such 
                manner as the Secretary may require.
                    (B) Contents.--Each application submitted to the 
                Secretary under subparagraph (A) include--
                            (i) a description of the regional 
                        boundaries of the consortium;
                            (ii) a description of the manufacturing 
                        concentration of the consortium, including an 
                        assessment of how the manufacturing 
                        concentration of the consortium competitively 
                        ranks nationally according to measures relating 
                        to employment, sales, location quotients for an 
                        industry's level of concentration, or such 
                        other measures as the Secretary considers 
                        appropriate;
                            (iii) an integrated assessment of the local 
                        industrial ecosystem of the region of the 
                        consortium, which may include assessment of 
                        workforce and training, such as that involving 
                        women and underrepresented minorities, supplier 
                        network, research and innovation, 
                        infrastructure or site development, trade and 
                        international investment, operational 
                        improvements, and capital access components 
                        needed for manufacturing activities in such 
                        region;
                            (iv) an evidence-based plan for developing 
                        components of such ecosystem (selected by the 
                        consortium)--
                                    (I) by making specific investments 
                                to address gaps in such ecosystem; and
                                    (II) by making the manufacturing of 
                                the region of the consortium uniquely 
                                competitive;
                            (v) a description of the investments the 
                        consortium proposes and the implementation 
                        strategy the consortium intends to use to 
                        address gaps in such ecosystem;
                            (vi) a description of the outcome-based 
                        metrics, benchmarks, and milestones that the 
                        consortium will track and the evaluation 
                        methods the consortium will use while 
                        designated as a manufacturing community to 
                        gauge performance of the strategy of the 
                        consortium to improve the manufacturing in the 
                        region of the consortium; and
                            (vii) such other matters as the Secretary 
                        considers appropriate.
            (6) Evaluation of applications.--The Secretary shall 
        evaluate each application received under paragraph (5) to 
        determine--
                    (A) whether the applicant demonstrates a 
                significant level of regional cooperation in their 
                proposal; and
                    (B) how the manufacturing concentration of the 
                applicant competitively ranks nationally according to 
                measures described in paragraph (5)(B)(ii).
            (7) Certain communities previously recognized.--Each 
        consortium that was designated as a manufacturing community by 
        the Secretary in carrying out the Investing in Manufacturing 
        Communities Partnership initiative of the Department of 
        Commerce before the date of the enactment of this Act shall be 
        deemed a manufacturing community designated under this 
        subsection if such consortium is still designated as a 
        manufacturing community by the Secretary as part of such 
        initiative.
    (c) Support for Designated Manufacturing Communities.--
            (1) Preferential consideration.--
                    (A) In general.--Except as provided in subparagraph 
                (D), if a member of a consortium designated as a 
                manufacturing community under subsection (b) seeks 
                financial or technical assistance under a participating 
                program of a participating agency, the head of such 
                agency may give preferential consideration to such 
                member with respect to the awarding of such financial 
                or technical assistance if--
                            (i) such head considers the award of the 
                        financial or technical assistance consistent 
                        with the economic development strategy of the 
                        consortium; and
                            (ii) the member otherwise meets all 
                        applicable requirements for the financial or 
                        technical assistance.
                    (B) Participating agencies.--The Secretary shall 
                invite other Federal agencies to become participating 
                agencies of the Manufacturing Community Support 
                Program.
                    (C) Participating programs.--The head of each 
                participating agency shall identify all programs 
                administered by such participating agency that are 
                applicable to the Manufacturing Community Support 
                Program.
                    (D) Multiple members of the same consortium seeking 
                the same financial or technical assistance.--
                            (i) In general.--If a participating agency 
                        receives applications for the same financial or 
                        technical assistance from more than one member 
                        of the same consortium designated as a 
                        manufacturing community under subsection (b), 
                        the head of such agency may determine how 
                        preference will be given under subparagraph 
                        (A), including by requiring the consortium to 
                        select which of the members should be given 
                        preference.
                            (ii) Coordination.--If the head of a 
                        participating agency determines that more than 
                        one member of a consortium should be given 
                        preference for financial or technical 
                        assistance under subparagraph (A), he or she 
                        may require such members to demonstrate 
                        coordination with each other in developing 
                        their applications for the financial or 
                        technical assistance.
                    (E) Report.--Not later than 90 days after the date 
                of the enactment of this Act, the head of each 
                participating agency shall submit a report to the 
                Secretary that specifies how the head will give 
                preferential consideration under subparagraph (A).
            (2) Technical assistance.--The Secretary may make a Federal 
        point of contact available to each consortium designated as a 
        manufacturing community under subsection (b) to help the 
        members of the consortium access Federal funds and technical 
        assistance.
            (3) Financial and technical assistance.--
                    (A) In general.--Under the Manufacturing Community 
                Support Program, the head of a participating agency may 
                award financial or technical assistance to a member of 
                a consortium designated as a manufacturing community 
                under subsection (b) as he or she considers appropriate 
                for purposes of such program and consistent with the 
                economic development strategy of the consortium.
                    (B) Use of funds.--
                            (i) In general.--A recipient of financial 
                        or technical assistance under subparagraph (A) 
                        may use such financial or technical assistance 
                        to support an investment in an ecosystem that 
                        will improve the competitiveness of United 
                        States manufacturing.
                            (ii) Investments supported.--Investments 
                        supported under this subparagraph may include--
                                    (I) infrastructure;
                                    (II) access to capital;
                                    (III) promotion of exports and 
                                foreign direct investment;
                                    (IV) equipment or facility 
                                upgrades;
                                    (V) workforce training, retraining, 
                                or recruitment and retention, including 
                                that of women and underrepresented 
                                minorities;
                                    (VI) energy or process efficiency;
                                    (VII) business incubators;
                                    (VIII) site preparation;
                                    (IX) advanced research;
                                    (X) supply chain development; and
                                    (XI) small business assistance.
            (4) Coordination.--
                    (A) Coordination by secretary of commerce.--The 
                Secretary shall coordinate with the heads of the 
                participating agencies to identify programs under 
                paragraph (1)(C).
                    (B) Inter-agency coordination.--The heads of the 
                participating agencies shall coordinate with each 
                other--
                            (i) to leverage complementary activities, 
                        including from non-Federal sources, such as 
                        philanthropies; and
                            (ii) to avoid duplication of efforts.
    (d) Receipt of Transferred Funds.--The Secretary may accept amounts 
transferred to the Secretary from the head of another participating 
agency to carry out this section.
[A]: Make It In America Manufacturing Communities Act This bill requires the Department of Commerce to establish a Manufacturing Community Support Program to improve the competitiveness of U.S. manufacturing by: (1) designating consortiums as manufacturing communities, and (2) authorizing federal agencies electing to participate in the program to provide such communities preferential consideration in awarding financial and technical assistance. A consortium, to be eligible for such designation and assistance, must:    represent a region that is large enough to contain critical elements of the key technologies or supply chain prioritized by the consortium and small enough to enable close collaboration among the consortium's members;   include at least one institution of higher education, a private sector entity, and a government entity; and   have a lead applicant that is a district organization, an Indian tribe, a state or political subdivision of a state, an institution of higher education, a nonprofit organization or association with an application supported by a state, a political subdivision of a state, or a native community.   Commerce shall make such designations for a two-year period, and may renew a designation for additional two-year periods, based on specified criteria.  Recipients may use such financial or technical assistance to support investments in ecosystems that will improve the competitiveness of U.S. manufacturing, including infrastructure, access to capital, promotion of exports and foreign direct investment, equipment upgrades, workforce training and recruitment, energy or process efficiency, business incubators, site preparation, advanced research, supply chain development, and small business assistance. 


[Q]: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Neutral Cost Recovery Act of 2001''.

SEC. 2. NEUTRAL COST RECOVERY DEPRECIATION ADJUSTMENT FOR CERTAIN 
              PROPERTY PLACED IN SERVICE AFTER DECEMBER 31, 2001.

    (a) In General.--Section 168 of the Internal Revenue Code of 1986 
(relating to accelerated cost recovery system) is amended by adding at 
the end thereof the following new subsection:
    ``(k) Deduction Adjustment To Allow Equivalent of Expensing for 
Certain Property Placed in Service After December 31, 2001.--
            ``(1) In general.--In the case of tangible property placed 
        in service after December 31, 2001, the deduction under this 
        section with respect to such property--
                    ``(A) shall be determined by substituting `150 
                percent' for `200 percent' in subsection (b)(1) in the 
                case of property to which the 200 percent declining 
                balance method would otherwise apply, and
                    ``(B) for any taxable year after the taxable year 
                during which the property is placed in service shall 
                be--
                            ``(i) the amount determined under this 
                        section for such taxable year without regard to 
                        this subparagraph, multiplied by
                            ``(ii) the applicable neutral cost recovery 
                        ratio for such taxable year.
            ``(2) Applicable neutral cost recovery ratio.--For purposes 
        of paragraph (1)--
                    ``(A) In general.--The applicable neutral cost 
                recovery ratio for the property for any taxable year is 
                the number determined by--
                            ``(i) dividing--
                                    ``(I) the gross domestic product 
                                deflator for the calendar quarter 
                                ending in such taxable year which 
                                corresponds to the calendar quarter 
                                during which the property was placed in 
                                service by the taxpayer, by
                                    ``(II) the gross domestic product 
                                deflator for the calendar quarter 
                                during which the property was placed in 
                                service by the taxpayer, and
                            ``(ii) then multiplying the number 
                        determined under clause (i) by the number equal 
                        to 1.035 to the nth power where `n' is the 
                        number of full years in the period beginning on 
                        the 1st day of the calendar quarter during 
                        which the property was placed in service by the 
                        taxpayer and ending on the day before the 
                        beginning of the corresponding calendar quarter 
                        ending during such taxable year.
                The applicable neutral cost recovery ratio shall never 
                be less than 1. The applicable neutral cost recovery 
                ratio shall be rounded to the nearest \1/1000\.
                    ``(B) Special rule for certain property.--In the 
                case of property described in paragraph (2) or (3) of 
                subsection (b) or in subsection (g), the applicable 
                neutral cost recovery ratio shall be determined without 
                regard to subparagraph (A)(ii).
            ``(3) Gross domestic product deflator.--For purposes of 
        paragraph (2), the gross domestic product deflator for any 
        calendar quarter is the implicit price deflator for the gross 
        domestic product for such quarter (as shown in the first 
        revision thereof).
            ``(4) Election not to have subsection apply.--This 
        subsection shall not apply to any property if the taxpayer 
        elects not to have this subsection apply to such property. Such 
        an election, once made, shall be irrevocable.
            ``(5) Churning transactions.--This subsection shall not 
        apply to any property if this section would not apply to such 
        property were subsection (f)(5)(A)(ii) applied by substituting 
        `2002' for `1981' and `2001' for `1980'.
            ``(6) Additional deduction not to affect basis or 
        recapture.--
                    ``(A) In general.--The additional amount determined 
                under this section by reason of this subsection shall 
                not be taken into account in determining the adjusted 
                basis of any property or of any interest in a pass-thru 
                entity which holds such property and shall not be 
                treated as a deduction for depreciation for purposes of 
                sections 1245 and 1250.
                    ``(B) Pass-thru entity defined.--For purposes of 
                subparagraph (A), the term `pass-thru entity' means--
                            ``(i) a regulated investment company,
                            ``(ii) a real estate investment trust,
                            ``(iii) an S corporation,
                            ``(iv) a partnership,
                            ``(v) an estate or trust, and
                            ``(vi) a common trust fund.''
    (b) Minimum Tax Treatment.--
            (1) Paragraph (1) of section 56(a) of such Code is amended 
        by adding at the end thereof the following new subparagraph:
                    ``(E) Use of neutral cost recovery ratio.--In the 
                case of property to which section 168(k) applies and 
                which is placed in service after December 31, 2001, the 
                deduction allowable under this paragraph with respect 
                to such property for any taxable year (after the 
                taxable year during which the property is placed in 
                service) shall be--
                            ``(i) the amount so allowable for such 
                        taxable year without regard to this 
                        subparagraph, multiplied by
                            ``(ii) the applicable neutral cost recovery 
                        ratio for such taxable year (as determined 
                        under section 168(k)).
                This subparagraph shall not apply to any property with 
                respect to which there is an election in effect not to 
                have section 168(k)) apply.''
            (2) Subparagraph (C) of section 56(g)(4) of such Code is 
        amended by adding at the end the following new clause:
                            ``(v) Neutral cost recovery deduction.--
                        Clause (i) shall not apply to the additional 
                        deduction allowable by reason of section 
                        168(k).''
    (c) Coordination With Depreciation Limitation on Certain 
Automobiles.--Clause (i) of section 280F(a)(1)(B) of such Code is 
amended by adding at the end the following new sentence: ``For purposes 
of this clause, the unrecovered basis of any passenger automobile shall 
be treated as including the additional amount determined under section 
168 by reason of subsection (k) thereof to the extent not allowed as a 
deduction by reason of this paragraph for any taxable year in the 
recovery period.''
    (d) Effective Date.--The amendments made by this section shall 
apply to taxable years ending after December 31, 2001.
[A]: Amends the Internal Revenue Code to require that the depreciation deduction for tangible property placed in service after 2001 be computed using neutral cost recovery ratios.


[Q]: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Right to Try Act''.

SEC. 2. USE OF UNAPPROVED MEDICAL PRODUCTS BY PATIENTS DIAGNOSED WITH A 
              TERMINAL ILLNESS.

    (a) In General.--Notwithstanding the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.), the Controlled Substances Act (21 
U.S.C. 801 et seq.), and any other provision of Federal law, the 
Federal Government shall not take any action to prohibit or restrict--
            (1) the production, manufacture, distribution, prescribing, 
        or dispensing of an experimental drug, biological product, or 
        device that--
                    (A) is intended to treat a patient who has been 
                diagnosed with a terminal illness; and
                    (B) is authorized by, and in accordance with, State 
                law; and
            (2) the possession or use of an experimental drug, 
        biological product, or device--
                    (A) that is described in subparagraphs (A) and (B) 
                of paragraph (1); and
                    (B) for which the patient has received a 
                certification from the patient's treating physician in 
                accordance with subsection (b).
    (b) Physician Certification.--A certification by the patient's 
treating physician referred to in subsection (a)(2)(B) must include 
each of the following:
            (1) A certification that the physician--
                    (A) is in good standing with the physician's 
                certifying organization or board; and
                    (B) has personally examined the patient.
            (2) A certification that there is no reason to conclude the 
        experimental drug, biological product, or device poses an 
        unreasonable and significant risk of danger to the patient.
            (3) A certification that the patient has been diagnosed 
        with a terminal disease or condition and does not have any 
        treatment options that--
                    (A) are comparable to treatment using the 
                experimental drug, biological product, or device or 
                otherwise satisfactory; and
                    (B) are approved, licensed, or cleared for 
                commercial distribution under section 505, 510(k), or 
                515 of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355, 360(k), 360(e)) or section 351 of the 
                Public Health Service Act (42 U.S.C. 262) and are 
                available to diagnose, monitor, or treat the patient's 
                disease or condition.
            (4) A certification that the probable risk to the patient 
        from the experimental drug, biological product, or device is 
        not greater than the probable risk from the patient's disease 
        or condition.
            (5) A certification that the physician has provided the 
        patient with a written statement and oral explanation of the 
        medical treatment to be provided using the experimental drug, 
        biological product, or device.
            (6) An acknowledgement signed by the patient (or the 
        patient's legal representative) that the physician has provided 
        the written statement and oral explanation required by 
        paragraph (5), and has disclosed the following:
                    (A) That the medical treatment using the 
                experimental drug, biological product, or device is 
                experimental or nonconventional.
                    (B) That the experimental drug, biological product, 
                or device has not been approved, licensed, or cleared 
                for commercial distribution under section 505, 510(k), 
                or 515 of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355, 360(k), 360(e)) or section 351 of the 
                Public Health Service Act (42 U.S.C. 262) for any 
                indication.
                    (C) The material risks generally recognized by a 
                reasonably prudent physician of the medical treatment's 
                side effects.
                    (D) An explanation of the medical treatment, 
                including the expected frequency and duration of the 
                treatment.
    (c) No Liability or Use of Outcomes.--
            (1) No liability.--Notwithstanding any other provision of 
        law, no liability shall lie against a producer, manufacturer, 
        distributor, prescriber, dispenser, possessor, or user of an 
        experimental drug, biological product, or device for the 
        production, manufacture, distribution, prescribing, dispensing, 
        possession, or use of an experimental drug, biological product, 
        or device that is in compliance, with subsection (a).
            (2) No use of outcomes.--Notwithstanding any other 
        provision of law, the outcome of any production, manufacture, 
        distribution, prescribing, dispensing, possession, or use of an 
        experimental drug, biological product, or device that was done 
        in compliance with subsection (a) shall not be used by a 
        Federal agency reviewing the experimental drug, biological 
        product, or device to delay or otherwise adversely impact 
        review or approval of such experimental drug, biological 
        product, or device.
    (d) Rules of Construction.--Nothing in this Act shall be construed 
to--
            (1) require a manufacturer or other person to make 
        available any experimental drug, biological product, or device; 
        or
            (2) prohibit a manufacturer or other person from receiving 
        compensation or recovering costs for the production, 
        manufacture, distribution, or sale of an experiment drug, 
        biological product, or device.
    (e) Definitions.--In this section:
            (1) Biological product.--The term ``biological product'' 
        has the meaning given to such term in section 351 of the Public 
        Health Service Act (42 U.S.C. 262).
            (2) Device; drug.--The terms ``device'' and ``drug'' have 
        the meanings given to such terms in section 201 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 321).
            (3) Experimental drug, biological product, or device.--The 
        term ``experimental drug, biological product, or device'' means 
        a drug, biological product, or device that--
                    (A) has successfully completed a phase 1 clinical 
                investigation;
                    (B) remains under investigation in a clinical trial 
                approved by the Food and Drug Administration; and
                    (C) is not approved, licensed, or cleared for 
                commercial distribution under section 505, 510(k), or 
                515 of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355, 360(k), 360(e)) or section 351 of the 
                Public Health Service Act (42 U.S.C. 262).
            (4) Phase 1 clinical investigation.--The term ``phase 1 
        clinical investigation'' means a phase 1 clinical 
        investigation, as described in section 312.21 of title 21, Code 
        of Federal Regulations (or any successor regulations).
            (5) Terminal illness.--The term ``terminal illness'' has 
        the meaning given to such term in the State law specified in 
        subsection (a)(1)(B).
[A]:
Right to Try Act This bill requires the federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are authorized by state law and intended to treat terminally ill patients. Patients receiving these treatments must be certified by a physician as having exhausted all other treatment options and as being at greater risk from their medical condition than the treatment. The physician must explain the treatment to the patient, including that the treatment is experimental, and the patient, or the patient's legal representative, must acknowledge the explanation. A manufacturer, distributor, prescriber, dispenser, possessor, or user of such a treatment has no liability regarding the treatment. The outcome of manufacture, distribution, prescribing, dispensing, possession, or use of such a treatment may not be used by a federal agency to adversely impact review or approval of the treatment. The treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the Food and Drug Administration (FDA); and (3) not be approved, licensed, or cleared for sale by the FDA.