In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
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Question: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Detroit Economic Competitiveness 
Act''.

SEC. 2. DETROIT JOBS TRUST FUND.

    (a) In General.--Subchapter A of chapter 98 of the Internal Revenue 
Code of 1986 is amended by adding at the end the following new section:

``SEC. 9512. DETROIT JOBS TRUST FUND.

    ``(a) Creation of Trust Fund.--There is established in the Treasury 
of the United States a trust fund to be known as the `Detroit Jobs 
Trust Fund', consisting of such amounts as may be appropriated or 
credited to such fund as provided in this section or section 9602(b).
    ``(b) Transfers to Trust Fund.--There are hereby appropriated to 
the Detroit Jobs Trust Fund amounts equivalent to receipts in the 
Treasury of taxes (including all income, excise, and employment taxes 
whether imposed with respect to individuals or businesses) imposed 
under this title (with respect to periods after the date of the 
enactment of this section) which are (as determined by the Secretary) 
attributable to Detroit, Michigan. The city of Detroit, Michigan, shall 
provide the Secretary such information as the Secretary may request for 
purposes of making the determinations required under this subsection. 
For purposes of this subsection, the taxes imposed on a corporation or 
other business entity shall not be treated as attributable to Detroit, 
Michigan, merely because the headquarters of such corporation or entity 
is located in Detroit, Michigan.
    ``(c) Expenditures.--
            ``(1) In general.--Except as otherwise provided in this 
        subsection, amounts in the Detroit Jobs Trust Fund shall 
        (without need of any further appropriation) be distributed 
        annually by the Secretary to the city of Detroit, Michigan, to 
        carry out the purposes described in paragraph (2).
            ``(2) Use of expenditures.--Amounts distributed to the city 
        of Detroit, Michigan, under this section shall be used for the 
        following purposes and in the following order of priority:
                    ``(A) First, of the amounts distributed with 
                respect the annual period not in excess of the Detroit 
                income tax suspension hold harmless amount, for any 
                purpose determined by the city government of Detroit, 
                Michigan.
                    ``(B) Second, for payment of principal and interest 
                on any general obligation issued by the city of 
                Detroit, Michigan (to the extent of such obligations).
                    ``(C) Third, for payment of principal and interest 
                on obligations to which section 103 applies and the 
                proceeds of which were used for the public schools of 
                the city of Detroit, Michigan (to the extent of such 
                obligations).
                    ``(D) Fourth, for jobs development, public safety, 
                education, business infrastructure, or public 
                infrastructure (to the extent consistent with the plan 
                described in paragraph (4)).
            ``(3) Restriction on distributions.--No distribution shall 
        be made by the Secretary under paragraph (1) unless--
                    ``(A) the city of Detroit, Michigan, does not 
                impose an income tax with respect to the period to 
                which such distribution relates,
                    ``(B) such city has reduced the aggregate property 
                taxes imposed by an amount not less than the reduction 
                in the payment obligations of such city by reason of 
                the payments described in paragraph (2),
                    ``(C) all prior distributions made to the city 
                under paragraph (2) were used by the city in a manner 
                consistent with the requirements of paragraph (2), and
                    ``(D) such city has provided such information to 
                the Comptroller General of the United States as the 
                Comptroller General may request to carry out section 
                2(b) of the Detroit Economic Competitiveness Act.
            ``(4) 5-year development plan.--A plan is described in this 
        paragraph if such plan--
                    ``(A) is a 5-year plan describing development goals 
                for Detroit, Michigan, and detailing how distributions 
                for purposes described in paragraph (2)(D) will be 
                spent,
                    ``(B) has been approved by simple majority vote of 
                the City Council of Detroit, Michigan (after 
                consultation with the Detroit Board of Education), and
                    ``(C) has been submitted to, and approved by, the 
                Secretary of the Treasury, the Secretary of Housing and 
                Urban Development, and the Secretary of Education.
        No distribution shall be made under paragraph (1) for a purpose 
        described in paragraph (2)(D) unless a plan described in this 
        paragraph is in effect and all prior such distributions for 
        such purposes were used in accordance with such plan.
            ``(5) Special rules during period of plan development.--
        During the period during which the plan described in paragraph 
        (4) is developed (but not in excess of the 5-month period 
        beginning on the date of the first distribution under paragraph 
        (1)), amounts distributed may be used concurrently for the 
        purposes described in subparagraphs (A), (B), and (C) of 
        paragraph (2).
            ``(6) Detroit income tax suspension hold harmless amount.--
                    ``(A) In general.--For purposes of paragraph 
                (2)(A), the term `Detroit income tax suspension hold 
                harmless amount' means the amount (as determined by the 
                Secretary) of revenue collected by the city of Detroit 
                pursuant to the income tax imposed by such city during 
                the calendar year preceding the calendar year which 
                includes the date of the enactment of this section.
                    ``(B) Cross reference.--For provision which 
                requires suspension of the Detroit income tax, see 
                paragraph (3)(A).
                    ``(C) Tax returns may still be required.--The city 
                of Detroit, Michigan, shall not be treated as failing 
                to satisfy the requirement of paragraph (3)(A) with 
                respect to any period merely because taxpayers are 
                required to file tax returns and report income with 
                respect to such period.
            ``(7) Amounts made available not to reduce other funding.--
        Amounts distributed to the city of Detroit, Michigan, under 
        this section shall supplement, and not supplant, any other 
        funding (including any Federal funding) for such city.
    ``(d) Termination.--No amount shall be distributed from, or 
appropriated to, the Detroit Jobs Trust Fund after the 5-year period 
beginning on the date of the enactment of this section. Any amounts 
remaining in such Trust Fund at the end of such period shall be 
transferred to the general fund of the Treasury. The 5-year period 
specified in this subsection shall not be renewed or extended.''.
    (b) GAO Reports.--The Comptroller General of the United States 
shall submit an annual report to Congress which--
            (1) describes the manner and purposes for which 
        distributions made from the Detroit Jobs Trust Fund have been 
        used,
            (2) describes the extent to which progress has been made 
        toward meeting the development goals under the plan described 
        in section 9512(c)(4) of the Internal Revenue Code of 1986 (as 
        added by this section) and whether such progress is consistent 
        with meeting such goals, and
            (3) includes any recommendations the Comptroller General 
        may have regarding improvements to the program described in 
        section 9512 of such Code.
The first such annual report shall be submitted not later than 90 days 
after the 1-year period beginning on the date of the enactment of this 
Act and the last such annual report shall be submitted not later than 
90 days after the date on which the Detroit Jobs Trust Fund terminates 
pursuant to section 9512(d) of such Code.
    (c) Clerical Amendment.--The table of sections for subchapter A of 
chapter 98 of the Internal Revenue Code of 1986 is amended by adding at 
the end the following new item:

``Sec. 9512. Detroit Jobs Trust Fund.''.

SEC. 3. ZERO CAPITAL GAINS RATE FOR CERTAIN NEW INVESTMENTS IN DETROIT, 
              MICHIGAN.

    (a) In General.--Subchapter Y of chapter 1 of the Internal Revenue 
Code of 1986 is amended by adding at the end the following new part:

        ``PART IV--CERTAIN NEW INVESTMENTS IN DETROIT, MICHIGAN

``Sec. 1400V. Zero capital gains rate for certain new investments in 
                            Detroit, Michigan.

``SEC. 1400V. ZERO CAPITAL GAINS RATE FOR CERTAIN NEW INVESTMENTS IN 
              DETROIT, MICHIGAN.

    ``(a) In General.--Gross income does not include any qualified 
capital gain from the sale or exchange of a specified new investment 
held for more than 1 year.
    ``(b) Specified New Investment.--For purposes of this section--
            ``(1) In general.--The term `specified new investment' 
        means--
                    ``(A) any qualified stock,
                    ``(B) any qualified partnership interest, and
                    ``(C) any qualified business property.
            ``(2) Qualified stock.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), the term `qualified stock' means any 
                stock in a domestic corporation if--
                            ``(i) such stock is acquired by the 
                        taxpayer during the 1-year period beginning on 
                        the date of the enactment of this section, at 
                        its original issue (directly or through an 
                        underwriter) from the corporation solely in 
                        exchange for cash,
                            ``(ii) as of the time such stock was 
                        issued, such corporation was a specified 
                        Detroit business (or, in the case of a new 
                        corporation, such corporation was being 
                        organized for purposes of being a specified 
                        Detroit business), and
                            ``(iii) during substantially all of the 
                        taxpayer's holding period for such stock, such 
                        corporation qualified as a specified Detroit 
                        business.
                    ``(B) Redemptions.--A rule similar to the rule of 
                section 1202(c)(3) shall apply for purposes of this 
                paragraph.
            ``(3) Qualified partnership interest.--The term `qualified 
        partnership interest' means any capital or profits interest in 
        a domestic partnership if--
                    ``(A) such interest is acquired by the taxpayer 
                during the 1-year period beginning on the date of the 
                enactment of this section, from the partnership solely 
                in exchange for cash,
                    ``(B) as of the time such interest was acquired, 
                such partnership was a specified Detroit business (or, 
                in the case of a new partnership, such partnership was 
                being organized for purposes of being a specified 
                Detroit business), and
                    ``(C) during substantially all of the taxpayer's 
                holding period for such interest, such partnership 
                qualified as a specified Detroit business.
        A rule similar to the rule of paragraph (2)(B) shall apply for 
        purposes of this paragraph.
            ``(4) Qualified business property.--
                    ``(A) In general.--The term `qualified business 
                property' means tangible property if--
                            ``(i) such property was acquired by the 
                        taxpayer by purchase (as defined in section 
                        179(d)(2)) during the 1-year period beginning 
                        on the date of the enactment of this section,
                            ``(ii) the original use of such property in 
                        Detroit, Michigan, commences with the taxpayer, 
                        and
                            ``(iii) during substantially all of the 
                        taxpayer's holding period for such property, 
                        substantially all of the use of such property 
                        was in a specified Detroit business of the 
                        taxpayer.
                    ``(B) Special rule for substantial improvements.--
                The requirements of clauses (i) and (ii) of 
                subparagraph (A) shall be treated as satisfied with 
                respect to--
                            ``(i) property which is substantially 
                        improved by the taxpayer before the end of the 
                        period described in subparagraph (A)(i), and
                            ``(ii) any land on which such property is 
                        located.
                The determination of whether a property is 
                substantially improved shall be made under clause (ii) 
                of section 1400B(b)(4)(B), except that `the date of the 
                enactment of section 1400V' shall be substituted for 
                `December 31, 1997' in such clause.
    ``(c) Qualified Capital Gain.--For purposes of this section--
            ``(1) In general.--Except as otherwise provided in this 
        subsection, the term `qualified capital gain' means any gain 
        recognized on the sale or exchange of--
                    ``(A) a capital asset, or
                    ``(B) property used in the trade or business (as 
                defined in section 1231(b)).
            ``(2) Gain before enactment not qualified.--The term 
        `qualified capital gain' shall not include any gain 
        attributable to periods before the date of the enactment of 
        this section.
            ``(3) Certain rules to apply.--Rules similar to the rules 
        of paragraphs (3), (4), and (5) of section 1400B(e) shall apply 
        for purposes of this subsection.
    ``(d) Specified Detroit Business.--For purposes of this section, 
the term `specified Detroit business' means any enterprise zone 
business (as defined in section 1397C), determined--
            ``(1) without regard to subsections (b)(6) and (c)(5) 
        thereof,
            ``(2) by substituting `80 percent' for `50 percent' in 
        subsections (b)(2) and (c)(1) thereof,
            ``(3) by treating Detroit, Michigan, as an empowerment zone 
        (and by treating no area other than Detroit, Michigan, as an 
        empowerment zone).
    ``(e) Certain Rules To Apply.--For purposes of this section, rules 
similar to the rules of paragraphs (6) and (7) of subsection (b), and 
subsections (f) and (g), of section 1400B shall apply; except that for 
such purposes section 1400B(g)(2) shall be applied by substituting 
`before the date of the enactment of section 1400V' for `before January 
1, 1998, or after December 31, 2014'.
    ``(f) Regulations.--The Secretary shall prescribe such regulations 
as may be appropriate to carry out the purposes of this section, 
including regulations to prevent the abuse of the purposes of this 
section.''.
    (b) Clerical Amendment.--The table of parts for subchapter Y of 
chapter 1 of such Code is amended by adding at the end the following 
new item:

       ``Part IV. Certain New Investments in Detroit, Michigan''.

    (c) Effective Date.--The amendments made by this section shall 
apply to property acquired after the date of the enactment of this Act.

Answer: Detroit Economic Competitiveness Act - Amends the Internal Revenue Code to establish the Detroit Jobs Trust Fund to finance economic development in Detroit, Michigan. Requires the Secretary of the Treasury to make annual distributions from such Fund to the city of Detroit for payment of debt obligations and for job development, public safety, education, and business and public infrastructure. Prohibits any distributions unless the city of Detroit: (1) does not impose an income tax during a period of distribution, (2) has made specified reductions in aggregate property taxes, (3) has used prior distributions as required under this Act, (4) has provided required information to the Comptroller General (GAO), and (5) has implemented a five-year plan describing development goals for Detroit and detailing how distributions from the Trust Fund will be spent. Terminates such Fund five years after enactment of this Act.

Requires GAO to submit annual reports to Congress describing the use of distributions from the Trust Fund, the extent to which progress has been made in meeting the plan's development goals, and Comptroller General recommendations for improving the program established under this Act.

Excludes from gross income capital gain from the sale or exchange of investment property used in trade or business in Detroit.


Question: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Tinnitus Research for Military 
Health Improvement Act''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Tinnitus, or the perception of sound where no external 
        source of such sound exists, is the most prevalent disabling 
        condition that affects members of the Armed Forces, most 
        notably those members who have been exposed to blast injuries 
        during combat, or other high noise level situations.
            (2) Tinnitus is the leading service-connected disability 
        for returning members of the Armed Forces and the prevalence of 
        tinnitus is continuing to increase at alarming rates.
            (3) An otologic, or ear, injury such as tinnitus has been 
        shown to decrease performance and situational awareness during 
        combat, seriously compromising the ability of a member of the 
        Armed Forces to hear and execute commands properly, thereby 
        jeopardizing not only the affected member but other members as 
        well.
            (4) While certain types of sensory impairment in combat or 
        other military activities may be readily apparent, otologic 
        injuries such as tinnitus may not be easily noticeable, which 
        necessitates the need for more rigorous screening for tinnitus 
        before and after deployment, and for additional research to 
        distinguish tinnitus from other forms of brain injury incurred 
        during combat.
            (5) Medical evidence to date suggests a demonstrated link 
        between tinnitus and post-traumatic stress disorder and 
        traumatic brain injury, such that improved understanding of 
        treatment of tinnitus may also directly advance research 
        efforts to address post-traumatic stress disorder and traumatic 
        brain injury.
            (6) Improving the treatment and prevention of tinnitus will 
        benefit all members of the Armed Forces who are increasingly at 
        risk of injury from high-decibel equipment or explosive 
        devices.

SEC. 3. CENTER OF EXCELLENCE FOR THE STUDY OF TINNITUS.

    (a) Establishment.--
            (1) In general.--The Secretary of Defense shall establish 
        one or more Centers of Excellence (in this section referred to 
        as a ``center'') for the study of tinnitus.
            (2) Location.--The Secretary shall establish a center at a 
        military installation in the United States where members of the 
        Armed Forces perform activities involving high rates of sound, 
        including artillery instruction and other basic combat training 
        related activities.
    (b) Responsibilities.--A center shall have the responsibilities as 
follows:
            (1) To study and enhance existing treatment modalities for 
        members of the Armed Forces with tinnitus, including diagnosed 
        cases of recurrent, chronic, or severe tinnitus.
            (2) To conduct basic and clinical research to prevent, 
        treat, and cure tinnitus, including studies on the neurological 
        changes in the brain associated with tinnitus.
            (3) To coordinate research activities with the Defense 
        Centers of Excellence for Psychological Health and Traumatic 
        Brain Injury in order to establish a tinnitus data registry for 
        members of the Armed Forces affected with tinnitus and other 
        neurological conditions that will enhance scientific progress 
        toward improvements in treatment for tinnitus and associated 
        neurological combat related conditions.
    (c) Reports.--Not later than one year after the date of the 
enactment of this Act, and annually thereafter, the Secretary of 
Defense shall submit to Congress a report on the activities of the 
center.
    (d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $7,000,000 for each of fiscal 
years 2011 through 2016.

SEC. 4. AURAL SCREENINGS FOR MEMBERS OF THE ARMED FORCES.

    (a) In General.--Paragraph (2) of section 1074f(b) of title 10, 
United States Code, is amended by adding at the end the following new 
subparagraph:
            ``(D) An aural screening, including an assessment of 
        tinnitus.''.
    (b) Effective Date.--Section 1074f(b)(2) of title 10, United States 
Code, as added by subsection (a) of this section, shall apply to 
members of the Armed Forces who are deployed or return from deployment 
on or after the date that is 30 days after the date of the enactment of 
this Act.

SEC. 5. GRANT PROGRAM TO ENCOURAGE TINNITUS RESEARCH.

    (a) In General.--Subject to the availability of appropriations 
provided for such purpose, the Secretary of Defense shall establish a 
program to award grants to institutions to assist such institutions in 
conducting research on recurrent, chronic, or severe tinnitus and 
peripheral neurological conditions, including research related to 
neurology, pharmacology, audiology, otolaryngology, and other 
disciplines that the Secretary determines appropriate according to 
newly discovered evidence-based findings.
    (b) Eligibility.--
            (1) Teaching program.--An institution eligible to receive a 
        grant under this section is--
                    (A) a hospital with a teaching program described in 
                section 1861(b)(6) of the Social Security Act (42 
                U.S.C. 1395x); or
                    (B) an educational institution with demonstrated 
                expertise in tinnitus research.
            (2) Application.--To be eligible to receive a grant under 
        this section, an institution shall submit an application to the 
        Secretary of Defense at such time, in such manner, and 
        containing such information as the Secretary may require. The 
        Secretary shall ensure that such applications are peer-reviewed 
        by multidisciplinary tinnitus experts from both the public and 
        private sector.
    (c) Grant Amount.--An institution awarded a grant under this 
section may not receive more than $2,500,000 per fiscal year under this 
section.
    (d) Reports.--Not later than December 31 of each year a grant may 
be awarded under this section, the Secretary of Defense shall submit to 
Congress a report on the grant program, including a summary of the 
research related to tinnitus conducted by each grant recipient.
    (e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $10,000,000 for each of fiscal 
years 2011 through 2016.

SEC. 6. IMPROVING AURAL PROTECTION FOR MEMBERS OF THE ARMED FORCES.

    (a) In General.--The Secretary of Defense shall examine methods to 
improve the aural protection for members of the Armed Forces in combat.
    (b) Report.--Not later than one year after the date of the 
enactment of this Act, the Secretary shall submit to Congress a report 
on the methods to improve aural protection examined under subsection 
(a).

SEC. 7. EXECUTIVE AGENT FOR TINNITUS.

    (a) Executive Agent.--Not later than 90 days after the date of the 
enactment of this Act, the Secretary of Defense shall designate a 
senior official of the Department of Defense to act as the executive 
agent for tinnitus.
    (b) Roles, Responsibilities, and Authorities.--
            (1) In general.--Not later than one year after the date of 
        the enactment of this Act, and in accordance with Directive 
        5101.1, the Secretary of Defense shall prescribe the roles, 
        responsibilities, and authorities of the executive agent 
        designated under subsection (a).
            (2) Specification.--The roles and responsibilities of the 
        executive agent designated under subsection (a) shall include 
        coordinating common functions related to tinnitus among the 
        military departments.
    (c) Support.--In accordance with Directive 5101.1, the Secretary of 
Defense shall ensure that the military departments, Defense Agencies, 
and other components of the Department of Defense provide the executive 
agent designated under subsection (a) with the appropriate support and 
resources needed to perform the roles, responsibilities, and 
authorities of the executive agent.
    (d) Definitions.--In this section:
            (1) The term ``Directive 5101.1'' means Department of 
        Defense Directive 5101.1, or any successor directive relating 
        to the responsibilities of an executive agent of the Department 
        of Defense.
            (2) The term ``executive agent'' has the meaning given the 
        term ``DoD Executive Agent'' in Directive 5101.1.

Answer: Tinnitus Research for Military Health Improvement Act - Directs the Secretary of Defense (DOD) to establish one or more centers of excellence for the study of tinnitus. Requires such centers to be established at military installations where members of the Armed Forces perform activities involving high rates of sound, including artillery instruction. Outlines center activities, including researching and enhancing treatments for members with tinnitus.

Requires the inclusion, within a current medical tracking system for members deployed overseas, of an aural screening which shall include an assessment of tinnitus.

Directs the Secretary to establish a grant program to assist eligible institutions in conducting research on recurrent, chronic, or severe tinnitus and peripheral neurological conditions. Makes eligible for such grants: (1) a hospital with an approved teaching program as defined under the Social Security Act; or (2) an educational institution with demonstrated expertise in tinnitus research.

Requires the Secretary to designate a senior DOD official to act as the executive agent for tinnitus.


Question: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Devices Technical 
Corrections Act''.

SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 107-250.

    (a) Title I; Fees Relating to Medical Devices.--Part 3 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379i et seq.), as added by section 102 of Public Law 107-250 
(116 Stat. 1589), is amended--
        (1) in section 737--
            (A) in paragraph (4)(B), by striking ``and for which 
        clinical data are generally necessary to provide a reasonable 
        assurance of safety and effectiveness'' and inserting ``and for 
        which substantial clinical data are necessary to provide a 
        reasonable assurance of safety and effectiveness'';
            (B) in paragraph (4)(D), by striking ``manufacturing,'';
            (C) in paragraph (5)(J), by striking ``a premarket 
        application'' and all that follows and inserting ``a premarket 
        application or premarket report under section 515 or a 
        premarket application under section 351 of the Public Health 
        Service Act.''; and
            (D) in paragraph (8), by striking ``The term `affiliate' 
        means a business entity that has a relationship with a second 
        business entity'' and inserting ``The term `affiliate' means a 
        business entity that has a relationship with a second business 
        entity (whether domestic or international)''; and
        (2) in section 738--
            (A) in subsection (a)(1)--
                (i) in subparagraph (A)--

                    (I) in the matter preceding clause (i) by striking 
                ``subsection (d),'' and inserting ``subsections (d) and 
                (e),'';
                    (II) in clause (iv), by striking ``clause (i),'' 
                and all that follows and inserting ``clause (i).''; and
                    (III) in clause (vii), by striking ``clause (i),'' 
                and all that follows and inserting ``clause (i), 
                subject to any adjustment under subsection 
                (e)(2)(C)(ii).''; and

                (ii) in subparagraph (D), in each of clauses (i) and 
            (ii), by striking ``application'' and inserting 
            ``application, report,'';
            (B) in subsection (d)(2)(B), beginning in the second 
        sentence, by striking ``firms. which show'' and inserting 
        ``firms, which show'';
            (C) in subsection (e)--
                (i) in paragraph (1), by striking ``Where'' and 
            inserting ``For fiscal year 2004 and each subsequent fiscal 
            year, where''; and
                (ii) in paragraph (2)--

                    (I) in subparagraph (B), beginning in the second 
                sentence, by striking ``firms. which show'' and 
                inserting ``firms, which show''; and
                    (II) in subparagraph (C)(i), by striking ``Where'' 
                and inserting ``For fiscal year 2004 and each 
                subsequent fiscal year, where'';

            (D) in subsection (f), by striking ``for filing''; and
            (E) in subsection (h)(2)(B)--
                (i) in clause (ii), by redesignating subclauses (I) and 
            (II) as items (aa) and (bb), respectively;
                (ii) by redesignating clauses (i) and (ii) as 
            subclauses (I) and (II), respectively;
                (iii) by striking ``The Secretary'' and inserting the 
            following:
                ``(i) In general.--The Secretary''; and
                (iv) by adding at the end the following:
                ``(ii) More than 5 percent.--To the extent such costs 
            are more than 5 percent below the specified level in 
            subparagraph (A)(ii), fees may not be collected under this 
            section for that fiscal year.''.
    (b) Title II; Amendments Regarding Regulation of Medical Devices.--
        (1) Inspections by accredited persons.--Section 704(g) of the 
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)), as added 
    by section 201 of Public Law 107-250 (116 Stat. 1602), is amended--
            (A) in paragraph (1), in the first sentence, by striking 
        ``conducting inspections'' and all that follows and inserting 
        ``conducting inspections of establishments that manufacture, 
        prepare, propagate, compound, or process class II or class III 
        devices, which inspections are required under section 510(h) or 
        are inspections of such establishments required to register 
        under section 510(i).'';
            (B) in paragraph (5)(B), in the first sentence, by striking 
        ``or poses'' and all that follows through the period and 
        inserting ``poses a threat to public health, fails to act in a 
        manner that is consistent with the purposes of this subsection, 
        or where the Secretary determines that there is a financial 
        conflict of interest in the relationship between the accredited 
        person and the owner or operator of a device establishment that 
        the accredited person has inspected under this subsection.'';
            (C) in paragraph (6)(A)--
                (i) in clause (i), by striking ``of the establishment 
            pursuant to subsection (h) or (i) of section 510'' and 
            inserting ``described in paragraph (1)'';
                (ii) in clause (ii)--

                    (I) in the matter preceding subclause (I)--

                        (aa) by striking ``each inspection'' and 
                    inserting ``inspections''; and
                        (bb) by inserting ``during a 2-year period'' 
                    after ``person''; and

                    (II) in subclause (I), by striking ``such a 
                person'' and inserting ``an accredited person'';

                (iii) in clause (iii)--

                    (I) in the matter preceding subclause (I), by 
                striking ``and the following additional conditions are 
                met:'' and inserting ``and 1 or both of the following 
                additional conditions are met:'';
                    (II) in subclause (I), by striking ``accredited'' 
                and all that follows through the period and inserting 
                ``(accredited under paragraph (2) and identified under 
                clause (ii)(II)) as a person authorized to conduct such 
                inspections of device establishments.''; and
                    (III) in subclause (II), by inserting ``or by a 
                person accredited under paragraph (2)'' after ``by the 
                Secretary'';

                (iv) in clause (iv)(I)--

                    (I) in the first sentence--

                        (aa) by striking ``the two immediately 
                    preceding inspections of the establishment'' and 
                    inserting ``inspections of the establishment during 
                    the previous 4 years''; and
                        (bb) by inserting ``section'' after ``pursuant 
                    to'';

                    (II) in the third sentence--

                        (aa) by striking ``the petition states a 
                    commercial reason for the waiver;''; and
                        (bb) by inserting ``not'' after ``the Secretary 
                    has not determined that the public health would''; 
                    and

                    (III) in the fourth sentence, by striking ``granted 
                until'' and inserting ``granted or deemed to be granted 
                until''; and

                (v) in clause (iv)(II)--

                    (I) by inserting ``of a device establishment 
                required to register'' after ``to be conducted''; and
                    (II) by inserting ``section'' after ``pursuant 
                to'';

            (D) in paragraph (6)(B)(iii)--
                (i) in the first sentence, by striking ``, and data 
            otherwise describing whether the establishment has 
            consistently been in compliance with sections 501 and 502 
            and other'' and inserting ``and with other''; and
                (ii) in the second sentence--

                    (I) by striking ``inspections'' and inserting 
                ``inspectional findings''; and
                    (II) by inserting ``relevant'' after ``together 
                with all other'';

            (E) in paragraph (6)(B)(iv)--
                (i) by inserting ``(I)'' after ``(iv)''; and
                (ii) by adding at the end the following:
    ``(II) If, during the two-year period following clearance under 
subparagraph (A), the Secretary determines that the device 
establishment is substantially not in compliance with this Act, the 
Secretary may, after notice and a written response, notify the 
establishment that the eligibility of the establishment for the 
inspections by accredited persons has been suspended.'';
            (F) in paragraph (6)(C)(ii), by striking ``in accordance 
        with section 510(h), or has not during such period been 
        inspected pursuant to section 510(i), as applicable'';
            (G) in paragraph (10)(B)(iii), by striking ``a reporting'' 
        and inserting ``a report''; and
            (H) in paragraph (12)--
                (i) by striking subparagraph (A) and inserting the 
            following:
        ``(A) the number of inspections conducted by accredited persons 
    pursuant to this subsection and the number of inspections conducted 
    by Federal employees pursuant to section 510(h) and of device 
    establishments required to register under section 510(i);''; and
                (ii) in subparagraph (E), by striking ``obtained by the 
            Secretary'' and all that follows and inserting ``obtained 
            by the Secretary pursuant to inspections conducted by 
            Federal employees;''.
        (2) Other corrections.--
            (A) Prohibited acts.--Section 301(gg) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331(gg)), as amended by 
        section 201(d) of Public Law 107-250 (116 Stat. 1609), is 
        amended to read as follows:
    ``(gg) The knowing failure to comply with paragraph (7)(E) of 
section 704(g); the knowing inclusion by a person accredited under 
paragraph (2) of such section of false information in an inspection 
report under paragraph (7)(A) of such section; or the knowing failure 
of such a person to include material facts in such a report.''.
            (B) Electronic labeling.--Section 502(f) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)), as amended by 
        section 206 of Public Law 107-250 (116 Stat. 1613), is amended, 
        in the last sentence--
                (i) by inserting ``or by a health care professional and 
            required labeling for in vitro diagnostic devices intended 
            for use by health care professionals or in blood 
            establishments'' after ``in health care facilities'';
                (ii) by inserting a comma after ``means'';
                (iii) by striking ``requirements of law and, that'' and 
            inserting ``requirements of law, and that'';
                (iv) by striking ``the manufacturer affords health care 
            facilities the opportunity'' and inserting ``the 
            manufacturer affords such users the opportunity''; and
                (v) by striking ``the health care facility''.
    (c) Title III; Additional Amendments.--
        (1) Effective date.--Section 301(b) of Public Law 107-250 (116 
    Stat. 1616), is amended by striking ``18 months'' and inserting 
    ``36 months''.
        (2) Premarket notification.--Section 510(o) of the Federal 
    Food, Drug, and Cosmetic Act (21 U.S.C. 360(o)), as added by 
    section 302(b) of Public Law 107-250 (116 Stat. 1616), is amended--
            (A) in paragraph (1)(B), by striking ``, adulterated'' and 
        inserting ``or adulterated''; and
            (B) in paragraph (2)--
                (i) in subparagraph (B), by striking ``, adulterated'' 
            and inserting ``or adulterated''; and
                (ii) in subparagraph (E), by striking ``semicritical'' 
            and inserting ``semi-critical''.
    (d) Miscellaneous Corrections.--
        (1) Certain amendments to section 515.--
            (A) In general.--
                (i) Technical correction.--Section 515(c) of the 
            Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)), 
            as amended by sections 209 and 302(c)(2)(A) of Public Law 
            107-250 (116 Stat. 1613, 1618), is amended by redesignating 
            paragraph (3) (as added by section 209 of such Public Law) 
            as paragraph (4).
                (ii) Modular review.--Section 515(c)(4)(B) of the 
            Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
            360e(c)(4)(B)) is amended by striking ``unless an issue of 
            safety'' and inserting ``unless a significant issue of 
            safety''.
            (B) Conforming amendment.--Section 210 of Public Law 107-
        250 (116 Stat. 1614) is amended by striking
        ``, as amended'' and all that follows through ``by adding'' and 
        inserting ``is amended in paragraph (3), as redesignated by 
        section 302(c)(2)(A) of this Act, by adding''.
        (2) Certain amendments to section 738.--
            (A) In general.--Section 738(a) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 379j(a)), as amended by subsection 
        (a), is amended--
                (i) in the matter preceding paragraph (1)--

                    (I) by striking ``(a) Types of Fees.--Beginning 
                on'' and inserting the following:

    ``(a) Types of Fees.--
        ``(1) In general.--Beginning on''; and

                    (II) by striking ``this section as follows:'' and 
                inserting ``this section.''; and

                (ii) by striking ``(1) Premarket application,'' and 
            inserting the following: ``(2) Premarket application,''.
            (B) Conforming amendments.--Section 738 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by 
        subparagraph (A), is amended--
                (i) in subsection (d)(1), in the last sentence, by 
            striking ``subsection (a)(1)(A)'' and inserting 
            ``subsection (a)(2)(A)'';
                (ii) in subsection (e)(1), by striking ``subsection 
            (a)(1)(A)(vii)'' and inserting ``subsection 
            (a)(2)(A)(vii)'';
                (iii) in subsection (e)(2)(C)--

                    (I) in each of clauses (i) and (ii), by striking 
                ``subsection (a)(1)(A)(vii)'' and inserting 
                ``subsection (a)(2)(A)(vii)''; and
                    (II) in clause (ii), by striking ``subsection 
                (a)(1)(A)(i)'' and inserting ``subsection 
                (a)(2)(A)(i)''; and

                (iv) in subsection (j), by striking ``subsection 
            (a)(1)(D),'' and inserting ``subsection (a)(2)(D),''.
            (C) Additional conforming amendment.--Section 102(b)(1) of 
        Public Law 107-250 (116 Stat. 1600) is amended, in the matter 
        preceding subparagraph (A), by striking ``section 
        738(a)(1)(A)(ii)'' and inserting ``section 738(a)(2)(A)(ii)''.
        (3) Public law 107-250.--Public Law 107-250 is amended--
            (A) in section 102(a) (116 Stat. 1589), by striking ``(21 
        U.S.C. 379F et seq.)'' and inserting ``(21 U.S.C. 379f et 
        seq.)'';
            (B) in section 102(b) (116 Stat. 1600)--
                (i) by striking paragraph (2);
                (ii) in paragraph (1), by redesignating subparagraphs 
            (A) and (B) as paragraphs (1) and (2), respectively; and
                (iii) by striking:
    ``(b) Fee Exemption for Certain Entities Submitting Premarket 
Reports.--
        ``(1) In general.--A person submitting a premarket report'' and 
    inserting:
    ``(b) Fee Exemption for Certain Entities Submitting Premarket 
Reports.--A person submitting a premarket report''; and
            (C) in section 212(b)(2) (116 Stat. 1614), by striking ``, 
        such as phase IV trials,''.
SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DEVICES INTENDED FOR 
CHILDREN.
    Not later than 180 days after the date of enactment of this Act, 
the Secretary of Health and Human Services shall submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives a 
report on the barriers to the availability of devices intended for the 
treatment or diagnosis of diseases and conditions that affect children. 
The report shall include any recommendations of the Secretary of Health 
and Human Services for changes to existing statutory authority, 
regulations, or agency policy or practice to encourage the invention 
and development of such devices.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.

Answer:
Medical Devices Technical Corrections Act - Amends the Federal Food, Drug, and Cosmetic Act (as amended by the Medical Device User Fee and Modernization Act of 2002) to revise provisions concerning medical devices user fees.

Prohibits the Secretary of Health and Human Services from collecting fees to defray costs in any fiscal year where the amount appropriated is more than five percent below the costs of the resources allocated for the review of device applications.

Allows the Secretary to withdraw accreditation to inspect from any person where the Secretary determines that there is a conflict of interest between the company and the accredited inspector.

Permits a company that markets at least one medical device in the United States and one medical device in another country to use an accredited third party inspector if the company certifies that the foreign country recognizes inspections by: (1) the Food and Drug Administration (FDA); and/or (2) the third party inspector. (Current law requires a country to recognize both types of inspections.)

Allows the Secretary to withdraw eligibility for third party inspections from a company if the Secretary determines that the company is substantially not in compliance with the Act.

Allows electronic labeling for prescription devices intended for use by health care professionals and for in vitro diagnostic devices intended for use by health care professionals or in blood establishments.

Delays by 18 additional months the effective date of the provision deeming a device misbranded if the identification of the manufacturer is not conspicuously displayed.

Directs the Secretary to submit a report to the relevant committees on the barriers to the availability of devices intended for treatment or diagnosis of diseases or conditions that affect children.