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SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pay It Back Act''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) the Congressional Budget Office estimates that the 
        deficit for this fiscal year will reach $1.6 trillion or 11 
        percent of the Gross Domestic Product;
            (2) this deficit represents the largest relative deficit 
        since the end of World War II;
            (3) the Congressional Budget Office estimates that the 
        fiscal year 2010 deficit will reach $1.4 trillion; and
            (4) given the choice between forcing our children to pay 
        for the national debt and requiring banks and other 
        beneficiaries of the goodwill of the taxpayer to make a down 
        payment now, we choose to help our kids.

SEC. 3. AMENDMENT TO TARP AUTHORIZATION.

    Section 115(a)(3) of the Emergency Economic Stabilization Act of 
2008 (12 U.S.C. 5225(a)(3)) is amended by striking ``outstanding at any 
one time'' and inserting ``, in the aggregate (or such higher amount, 
in the aggregate, as has been obligated or expended under this Act as 
of the date of enactment of the Pay It Back Act)''.

SEC. 4. REPORT.

    Section 106 of the Emergency Economic Stabilization Act of 2008 (12 
U.S.C. 5216) is amended by inserting at the end the following:
    ``(f) Report.--The Secretary of the Treasury shall report to 
Congress every 6 months on amounts received and transferred to the 
general fund under subsection (d).''.

SEC. 5. AMENDMENTS TO HOUSING AND ECONOMIC RECOVERY ACT OF 2008.

    (a) Sale of Fannie Mae Obligations and Securities by the Treasury; 
Deficit Reduction.--Section 304(g)(2) of the Federal National Mortgage 
Association Charter Act (12 U.S.C. 1719(g)(2)) is amended--
            (1) by redesignating subparagraph (C) as subparagraph (D); 
        and
            (2) by inserting after subparagraph (B) the following:
                    ``(C) Deficit reduction.--The Secretary of the 
                Treasury shall--
                            ``(i) deposit in the General Fund of the 
                        Treasury any amounts received by the Secretary 
                        for the sale of any obligation or security 
                        acquired by the Secretary under this 
                        subsection; and
                            ``(ii) ensure that such amounts so 
                        deposited--
                                    ``(I) are dedicated for the sole 
                                purpose of deficit reduction; and
                                    ``(II) are prohibited from use as 
                                an offset for other spending increases 
                                or revenue reductions.''.
    (b) Sale of Freddie Mac Obligations and Securities by the Treasury; 
Deficit Reduction.--Section 306(l)(2) of the Federal Home Loan Mortgage 
Corporation Act (12 U.S.C. 1455(l)(2)) is amended--
            (1) by redesignating subparagraph (C) as subparagraph (D); 
        and
            (2) by inserting after subparagraph (B) the following:
                    ``(C) Deficit reduction.--The Secretary of the 
                Treasury shall--
                            ``(i) deposit in the General Fund of the 
                        Treasury any amounts received by the Secretary 
                        for the sale of any obligation or security 
                        acquired by the Secretary under this 
                        subsection; and
                            ``(ii) ensure that such amounts so 
                        deposited--
                                    ``(I) are dedicated for the sole 
                                purpose of deficit reduction; and
                                    ``(II) are prohibited from use as 
                                an offset for other spending increases 
                                or revenue reductions.''.
    (c) Sale of Federal Home Loan Banks Obligations by the Treasury; 
Deficit Reduction.--Section 11(l)(2) of the Federal Home Loan Bank Act 
(12 U.S.C. 1431(l)(2)) is amended--
            (1) by redesignating subparagraph (C) as subparagraph (D); 
        and
            (2) by inserting after subparagraph (B) the following:
                    ``(C) Deficit reduction.--The Secretary of the 
                Treasury shall--
                            ``(i) deposit in the General Fund of the 
                        Treasury any amounts received by the Secretary 
                        for the sale of any obligation acquired by the 
                        Secretary under this subsection; and
                            ``(ii) ensure that such amounts so 
                        deposited--
                                    ``(I) are dedicated for the sole 
                                purpose of deficit reduction; and
                                    ``(II) are prohibited from use as 
                                an offset for other spending increases 
                                or revenue reductions.''.
    (d) Repayment of Fees.--Any periodic commitment fee or any other 
fee or assessment paid by the Federal National Mortgage Association or 
Federal Home Loan Mortgage Corporation to the Secretary of the Treasury 
as a result of any preferred stock purchase agreement, mortgage-backed 
security purchase program, or any other program or activity authorized 
or carried out pursuant to the authorities granted to the Secretary of 
the Treasury under the amendments made by section 1117 of the Housing 
and Economic Recovery Act of 2008 (Public Law 110-289; 122 Stat. 2683), 
including any fee agreed to by contract between the Secretary and the 
Association or Corporation, shall be deposited in the General Fund of 
the Treasury where such amounts shall be--
            (1) dedicated for the sole purpose of deficit reduction; 
        and
            (2) prohibited from use as an offset for other spending 
        increases or revenue reductions.

SEC. 6. FEDERAL HOUSING FINANCE AGENCY REPORT.

    The Director of the Federal Housing Finance Agency shall submit to 
Congress a report on the plans of the Agency to continue to support and 
maintain the Nation's vital housing industry, while at the same time 
guaranteeing that the American taxpayer will not suffer unnecessary 
losses.

SEC. 7. REPAYMENT OF UNOBLIGATED ARRA FUNDS.

    (a) Rejection of ARRA Funds by State.--Section 1607 of division A 
of the American Recovery and Reinvestment Act of 2009 (Public Law 111-
5; 123 Stat. 303) is amended by adding at the end the following:
    ``(d) Statewide Rejection of Funds.--If funds provided to any State 
in any division of this Act are not accepted for use by the Governor of 
the State pursuant to subsection (a) or by the State legislature 
pursuant to subsection (b), then all such funds shall be--
            ``(1) rescinded; and
            ``(2) deposited in the General Fund of the Treasury, where 
        such amounts shall be--
                    ``(A) dedicated for the sole purpose of deficit 
                reduction; and
                    ``(B) prohibited from use as an offset for other 
                spending increases or revenue reductions.''.
    (b) Withdrawal or Recapture of Unobligated Funds.--Title XVI of 
division A of the American Recovery and Reinvestment Act of 2009 
(Public Law 111-5; 123 Stat. 302) is amended by adding at the end the 
following:

             ``withdrawal or recapture of unobligated funds

    ``Sec. 1613. Notwithstanding any other provision of this Act, if 
the head of any executive agency withdraws or recaptures for any reason 
funds appropriated or otherwise made available under this division, and 
such funds have not been obligated by a State to a local government or 
for a specific project, such recaptured funds shall be--
            ``(1) rescinded; and
            ``(2) deposited in the General Fund of the Treasury, where 
        such amounts shall be--
                    ``(A) dedicated for the sole purpose of deficit 
                reduction; and
                    ``(B) prohibited from use as an offset for other 
                spending increases or revenue reductions.''.
    (c) Return of Unobligated Funds by End of 2012.--Section 1603 of 
division A of the American Recovery and Reinvestment Act of 2009 
(Public Law 111-5; 123 Stat. 302) is amended--
            (1) by striking ``All funds'' and inserting ``(a) In 
        General.--All funds''; and
            (2) by adding at the end the following:
    ``(b) Repayment of Unobligated Funds.--Any discretionary 
appropriations made available in this division that have not been 
obligated as of December 31, 2012, are hereby rescinded, and such 
amounts shall be deposited in the General Fund of the Treasury, where 
such amounts shall be--
            ``(1) dedicated for the sole purpose of deficit reduction; 
        and
            ``(2) prohibited from use as an offset for other spending 
        increases or revenue reductions.
    ``(c) Presidential Waiver Authority.--
            ``(1) In general.--The President may waive the requirements 
        under subsection (b), if the President determines that it is 
        not in the best interest of the Nation to rescind a specific 
        unobligated amount after December 31, 2012.
            ``(2) Requests.--The head of an executive agency may also 
        apply to the President for a waiver from the requirements under 
        subsection (b).''.

SEC. 8. REDUCTION OF STATUTORY LIMIT ON THE PUBLIC DEBT.

    Section 3101 of title 31, United States Code, is amended--
            (1) in subsection (b), by inserting ``minus the aggregate 
        amounts described in subsection (d)'' before ``, outstanding at 
        one time''; and
            (2) by adding at the end the following:
    ``(d) Amounts described in this subsection are any amounts received 
by the Secretary of the Treasury pursuant to--
            ``(1) section 106(d) of the Emergency Economic 
        Stabilization Act of 2008 before, on, or after the date of 
        enactment of this subsection; and
            ``(2) section 304(g) of the Federal National Mortgage 
        Association Charter Act (12 U.S.C. 1719(g)), section 306(l) of 
        the Federal Home Loan Mortgage Corporation Act (12 U.S.C. 
        1455(l)), section 11(l) of the Federal Home Loan Bank Act (12 
        U.S.C. 1431(l)), section 1607(d) of division A of the American 
        Recovery and Reinvestment Act of 2009 (Public Law 111-5), 
        section 1613 of division A of the American Recovery and 
        Reinvestment Act of 2009 (Public Law 111-5), and sections 5(d) 
        and 7(c) of the Pay It Back Act after the date of enactment of 
        this subsection.''.
Pay It Back Act - Amends the Emergency Economic Stabilization Act of 2008 (EESA) to revise the limitation on the authority of the Secretary of the Treasury to purchase troubled assets under the Troubled Asset Relief Program (TARP) to $700 billion outstanding at any one time. Changes the maximum authority to $700 billion, in the aggregate, or such higher amount, in the aggregate, as has been obligated or expended under TARP as of the enactment of this Act.

Requires the Secretary to report to Congress every six months on transfer to the Treasury's General Fund for reduction of the public debt of revenues of, and proceeds from the sale of troubled assets purchased under TARP, or from the sale, exercise, or surrender of warrants or senior debt instruments acquired under TARP.

Amends the Federal National Mortgage Association Charter Act, the Federal Home Loan Mortgage Corporation Act, and the Federal Home Loan Bank Act to require the Secretary to deposit in the Treasury solely for debt reduction any amounts received by the Secretary for the sale of any obligation or security acquired from the Federal National Mortgage Association (Fannie Mae), the Federal Home Loan Mortgage Corporation (Freddie Mac), or a Federal Home Loan Bank for secondary market operations. Prohibits the use of any such amounts as an offset for other spending increases or revenue reductions.

Requires deposit in the Treasury solely for debt reduction of any periodic commitment fee or any other fee or assessment paid to the Secretary by Fannie Mae or Freddie Mac as a result of any preferred stock purchase agreement, mortgage-backed security purchase program, or any other program or activity under the Housing and Economic Recovery Act of 2008.

Requires the Director of the Federal Housing Finance Agency (FHFA) to report to Congress on FHFA plans to continue to support and maintain the nation's vital housing industry, while at the same time guaranteeing that the American taxpayer will not suffer unnecessary losses.

Amends the American Recovery and Reinvestment Act of 2009 (ARRA) to require: (1) rescission of any ARRA (stimulus) funds offered to but not accepted by the governor or legislature of a state; and (2) their deposit in the Treasury solely for debt reduction. Requires the same treatment for any funds withdrawn or recaptured by an executive agency head which have not been obligated by a state to a local government or for a specific project.

Rescinds for deposit in the Treasury solely for debt reduction specified discretionary appropriations that have not been obligated as of December 31, 2012.

Lowers the statutory limit on the public debt by the amounts the Secretary receives under this Act for deposit in the Treasury solely for debt reduction.

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.
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.

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Medicare IVIG 
Access Act of 2007''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Medicare payment for immune globulins.
Sec. 4. Coverage and payment of intravenous immune globulin in the 
                            home.
Sec. 5. Patient access surveys and reports.

SEC. 2. FINDINGS.

    (a) Findings.--Congress finds the following:
            (1) Intravenous immune globulin (IVIG) is a human blood 
        plasma derived product, which over the past 25 years has become 
        an invaluable therapy for many primary immunodeficiency 
        diseases, as well as a number of neurological, autoimmune, and 
        other chronic conditions and illnesses. For many of these 
        disorders, IVIG is the most effective and viable treatment 
        available, and has dramatically improved the quality of life 
        for persons with these conditions and has become a life-saving 
        therapy for many.
            (2) The Food and Drug Administration (FDA) recognizes each 
        IVIG brand as a unique biologic. The differences in basic 
        fractionation and the addition of various modifications for 
        further purification, stabilization and virus inactivation/
        removal yield clearly different biological products. As a 
        result, IVIG therapies are not interchangeable, with patient 
        tolerance differing from one IVIG brand to another.
            (3) The report of the Office of the Assistant Secretary for 
        Planning and Evaluation (ASPE), Department of Health and Human 
        Services (DHHS), ``Analysis of Supply, Distribution, Demand, 
        and Access Issues Associated with Immune Globulin Intravenous 
        (IGIV)'', issued in May 2007, found that IVIG manufacturing is 
        complex and requires substantial upfront cash outlay and 
        planning and takes between seven and 12 months from plasma 
        collection at donor centers to FDA lot release.
            (4) The Medicare Prescription Drug, Improvement, and 
        Modernization Act of 2003 changed Medicare's reimbursement 
        methodology for IVIG from average wholesale price (AWP) to 
        average sales price plus 6 percent (ASP+6), effective January 
        1, 2005, for physicians, and January 1, 2006, for hospital 
        outpatient departments, thereby reducing reimbursement rates 
        paid to these providers of IVIG on behalf of Medicare 
        beneficiaries.
            (5) An Office of the Inspector General (OIG) April 2007 
        report, Intravenous Immune Globulin: Medicare Payment and 
        Availability, found that Medicare reimbursement for IVIG was 
        inadequate to cover the cost many providers must pay for the 
        product. During the third quarter of 2006, 44 percent of IVIG 
        sales to hospitals and 41 percent of sales to physicians by the 
        three largest distributors occurred at prices above Medicare 
        payment amounts.
            (6) The ASPE report notes that after the new reimbursement 
        rules for physicians was instituted in 2005, 42 percent of 
        Medicare beneficiaries who had received their IVIG treatment in 
        their physician's office at the end of 2004 were shifted to the 
        hospital outpatient setting by the beginning of 2006. This 
        shift in site of care has resulted in lack of continuity of 
        care and adverse impact on health outcomes and quality of life.
            (7) The OIG also reported that 61 percent of responding 
        physicians indicated that they had sent patients to hospitals 
        for IVIG treatment, largely because of their inability to 
        purchase IVIG at prices below the Medicare payment amounts. In 
        addition, OIG found that some physicians had stopped providing 
        IVIG to Medicare beneficiaries altogether.
            (8) The OIG's 2007 report concluded that whatever 
        improvement some providers saw in the relationship of Medicare 
        reimbursement for IVIG to prices paid during the first three 
        quarters of 2006 would be eroded if manufacturers were to 
        increase prices for IVIG in the future.
            (9) The Centers for Medicare & Medicaid Services, in 
        recognition of dislocations experienced by patients and 
        providers in obtaining IVIG since the change to the ASP+6 
        reimbursement methodology, has provided during 2006 and 2007 a 
        temporary additional payment for IVIG preadministration-related 
        services to compensate physicians and hospital outpatient 
        departments for the extra resources they have had to expend in 
        locating and obtaining appropriate IVIG products and in 
        scheduling patient infusions.
            (10) Approximately 10,000 Medicare beneficiaries receive 
        IVIG treatment for their primary immunodeficiency disease in a 
        variety of different settings. They have no other effective 
        treatment for their condition.
            (11) The Medicare Modernization Act of 2003 (MMA) 
        established an IVIG home infusion benefit for persons with 
        primary immunodeficiency disease (PIDD), paying only for IVIG 
        and specifically excluding coverage of items and services 
        related to administration of the product.
            (12) The ASPE report, Analysis of Supply, Distribution, 
        Demand, and Access Issues Associated with Immune Globulin 
        Intravenous (IGIV), found that Medicare's IVIG home infusion 
        benefit is not designed to reimburse for more than the cost of 
        IVIG and does not cover the cost of infusion services (for 
        example, nursing and clinical services and supplies) in the 
        home. As a consequence, the report found that home infusion 
        providers generally do not accept new PIDD patients with only 
        Medicare coverage. These limitations in service are caused by 
        health care providers (A) not being able to acquire IVIG at 
        prices at or below the Medicare part B reimbursement level, and 
        (B) not being reimbursed for the infusion services provided by 
        a nurse.
            (13) Access to home infusion of IVIG for PIDD patients, who 
        have a genetic or intrinsic defect in their human immune 
        system, will reduce their exposure to infections at a time when 
        their antibodies are compromised and will improve the quality 
        of their care and their health.

SEC. 3. MEDICARE PAYMENT FOR IMMUNE GLOBULINS.

    (a) In General.--Section 1842(o)(1)(E) of the Social Security Act 
(42 U.S.C. 1395u(o)(1)(E)) is amended--
            (1) in paragraph (1)(E)(ii), by inserting before the period 
        the following: ``, plus an additional amount (if applicable) 
        under paragraph (7)'';
            (2) in paragraph (7), by striking ``(6)'' and inserting 
        ``(7)'' and by redesignating it as paragraph (8); and
            (3) by inserting after paragraph (6) the following new 
        paragraph:
            ``(7)(A) Not later than 6 months after the date of the 
        enactment of the Medicare IVIG Access Act of 2007, the 
        Secretary shall--
                    ``(i) collect data on the differences, if any, 
                between payments to physicians for immune globulins 
                under paragraph (1)(E)(ii) and costs incurred by 
                physicians for furnishing these products; and
                    ``(ii) review available data, including survey data 
                presented by members of the IVIG community on the 
                access of individuals eligible for services under this 
                part to immune globulins.
            ``(B) Upon completion of the review and collection of data 
        under subparagraph (A), and not later than 7 months after the 
        date of the enactment of this paragraph, the Secretary shall 
        provide, if appropriate, to physicians furnishing immune 
        globulins, a payment, in addition to the payment provided for 
        in paragraph (1)(E)(ii), for all items related to the 
        furnishing of immune globulins, in an amount that the Secretary 
        determines to be appropriate.
            ``(C) In the case of immune globulins furnished on or after 
        January 1, 2007, the Secretary shall continue the 
        preadministration-related services payment established under 
        the Final Physician Fee Schedule Rule issued by the Centers for 
        Medicare & Medicaid Services on November 1, 2006 (CMS-1321-FC), 
        until such time as the Secretary determines that payment for 
        immune globulins is adequate or until a new payment methodology 
        is implemented.''.
    (b) As Part of Hospital Outpatient Services.--Section 1833(t)(14) 
of such Act (42 U.S.C. 1395l(t)(14)) is amended--
            (1) in subparagraph (A)(iii), by striking ``subparagraph 
        (E)'' and inserting ``subparagraphs (E) and (I)''; and
            (2) by adding at the end the following new subparagraph:
                    ``(I) Additional payment for immune globulins.--
                            ``(i) Data collection and review.--Not 
                        later than 6 months after the date of the 
                        enactment of the Medicare IVIG Access Act of 
                        2007, the Secretary shall--
                                    ``(I) review available data, 
                                including survey data presented by 
                                members of the IVIG community, on the 
                                access of individuals eligible for 
                                services under this part to immune 
                                globulins; and
                                    ``(II) collect data on the 
                                differences, if any, between payments 
                                for immune globulins under subparagraph 
                                (A)(iii) and costs incurred for 
                                furnishing these products.
                            ``(ii) Additional payment authority.--Upon 
                        completion of the review and collection of data 
                        under clause (i), and not later than 7 months 
                        after the date of the enactment of this 
                        subparagraph, the Secretary shall provide, if 
                        appropriate, to hospitals furnishing immune 
                        globulins as part of a covered OPD service, a 
                        payment, in addition to the payment provided 
                        for under subparagraph (A)(iii), for all items 
                        related to the furnishing of immune globulins, 
                        in an amount that the Secretary determines to 
                        be appropriate.
                            ``(iii) Continuation of special payment 
                        rule.--In the case of immune globulins 
                        furnished on or after January 1, 2007, the 
                        Secretary shall continue the preadministration-
                        related services payment established under the 
                        Final Hospital Outpatient Rule issued by the 
                        Centers for Medicare & Medicaid Services 
                        November 1, 2006 (CMS-1506-FC), until such time 
                        as the Secretary determines that payment for 
                        immune globulins is adequate or until a new 
                        payment methodology is implemented.''.

SEC. 4. COVERAGE AND PAYMENT OF INTRAVENOUS IMMUNE GLOBULIN IN THE 
              HOME.

    (a) Including Coverage of Administration.--
            (1) In general.--Section 1861 of the Social Security Act 
        (42 U.S.C. 1395x) is amended--
                    (A) in subsection (s)(2)(Z), by inserting before 
                the semicolon at the end the following: ``, regardless 
                of whether the individual receiving the globulin is 
                eligible to receive home health services under this 
                title''; and
                    (B) in subsection (zz), by striking ``but not 
                including items or services related to the 
                administration of the derivative''.
            (2) Conforming home health amendment.--Section 1814(a) of 
        such Act (42 U.S.C. 1395f(a)) is amended by adding at the end 
        the following: ``An individual eligible for intravenous immune 
        globulin under section 1861(s)(2)(Z) shall not be considered 
        eligible for home health services under paragraph (2)(C) or 
        section 1835(a)(2)(A) solely on the basis of meeting the 
        requirements of such subsection or section 1861(zz).''.
    (b) Payment for Intravenous Immune Globulin Administration in the 
Home.--Section 1834 of such Act (42 U.S.C. 1395m) is amended by adding 
at the end the following new subsection:
    ``(n) Payment for Intravenous Immune Globulin in the Home.--The 
Secretary shall review available published and unpublished data and 
information, including the Study of Intravenous Immune Globulin 
Administration Options: Safety, Access, and Cost Issues (CMS Contract 
#500-95-0059), on confirming the appropriateness of administration of 
intravenous immune globulin in the home setting, and (as appropriate) 
calculate the amount, in addition to that made under section 
1842(o)(1)(E)(ii) for immune globulins, that should be paid to 
providers for clinical, compliance, and complication management 
services for ensuring safe and efficacious delivery of immune globulins 
in the home setting under 1861(s)(2)(Z). The Secretary shall pay such 
amounts no later than January 1, 2008.''.
    (c) Application of Criminal Record Request Provisions to IVIG In-
Home Providers.--Section 124(i)(1) of the Departments of Commerce, 
Justice, State, the Judiciary, and Related Agencies Appropriations Act, 
1999 (as contained in section 1(b) of Public Law 105-277; 112 Stat. 
2681-74) is amended by adding at the end the following: ``Such term 
includes an entity providing intravenous immune globulin under part B 
of title XVIII of the Social Security Act in a home.''.
    (d) Effective Date.--The amendments made by subsections (a) and (b) 
shall apply to intravenous immune globulin administered on or after 
January 1, 2008.

SEC. 5. PATIENT ACCESS SURVEYS AND REPORTS.

    (a) Surveys.--The Secretary of Health and Human Services shall 
conduct, not later than 3 years after the date of the enactment of this 
Act, two surveys of Medicare and non-Medicare patients who need immune 
globulins for the purpose of measuring changes in patient access to 
those products (and providers furnishing those products), as well as 
changes in the health care status of those patients. The Secretary may 
enter into contracts with organizations or entities qualified to 
conduct such surveys.
    (b) Survey Reports.--Each of the surveys shall include a report to 
the Secretary and the Committees on Energy and Commerce and Ways and 
Means of the House of Representatives and the Committee on Finance of 
the Senate on findings from the survey, as well as a discussion of 
reasons for observed changes, if any.
    (c) Congressional Reports.--On the basis of findings from such 
surveys, the Secretary shall submit to Congress reports that include 
recommendations on necessary adjustments in payments for immune 
globulins under the Medicare program in order to assure beneficiary 
access to those products and providers that furnish those products. The 
first such report shall be submitted no later than 2 years after the 
date of the enactment of this Act and the second report no later than 
four years after such date.

Medicare IVIG Access Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to collect and review data on the differences, if any, between: (1) payments to physicians for immune globulins using average sales price payment methodology; and (2) costs incurred by physicians for furnishing these products.

Requires the Secretary, after completion of the review, to provide, if appropriate, an additional payment to such physicians for all items related to the furnishing of immune globulins as part of hospital outpatient services.

Provides for Medicare coverage of and payment for intravenous immune globulin (IVIG) administered in the home.

Directs the Secretary to conduct two surveys, for reports to Congress, of Medicare and non-Medicare patients who need immune globulins in order to measure changes in patient access to those products (and providers furnishing them), as well as changes in the health care status of those patients.