[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3493 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 3493

  To amend the Federal Food, Drug, and Cosmetic Act to make technical 
corrections relating to the amendments made by the Medical Device User 
       Fee and Modernization Act of 2002, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 17, 2003

  Mr. Greenwood (for himself and Ms. Eshoo) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to make technical 
corrections relating to the amendments made by the Medical Device User 
       Fee and Modernization Act of 2002, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Devices Technical 
Corrections Act of 2003''.

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

    (a) Title I; Fees Relating to Medical Devices.--
            (1) Types of fees.--Section 738 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 379j), as added by section 102 of 
        Public Law 107-250 (116 Stat. 1589), is amended by amending 
        subsection (a) to read as follows:
    ``(a) Types of Fees.--Beginning on the date of the enactment of the 
Medical Device User Fee and Modernization Act of 2002, the Secretary 
shall assess and collect fees in accordance with this section as 
follows:
            ``(1) Premarket application, premarket report, supplement, 
        and submission fee.--Except as provided in paragraph (2) and 
        subsections (d) and (e), each person who submits any of the 
        following, on or after October 1, 2002, shall be subject to a 
        fee established under subsection (c)(5) for the fiscal year 
        involved in accordance with the following:
                    ``(A) A premarket application.
                    ``(B) For a premarket report, a fee equal to the 
                fee that applies under subparagraph (A).
                    ``(C) For a panel track supplement, a fee equal to 
                the fee that applies under subparagraph (A).
                    ``(D) For a 180-day supplement, a fee equal to 21.5 
                percent of the fee that applies under subparagraph (A).
                    ``(E) For a real-time supplement, a fee equal to 
                7.2 percent of the fee that applies under subparagraph 
                (A).
                    ``(F) For an efficacy supplement, a fee equal to 
                the fee that applies under subparagraph (A).
                    ``(G) For a premarket notification submission, a 
                fee equal to 1.42 percent of the fee that applies under 
                subparagraph (A), subject to any adjustment under 
                subsection (e)(2)(C)(ii).
            ``(2) Exceptions.--
                    ``(A) Humanitarian device exemption.--An 
                application under section 520(m) is not subject to any 
                fee under paragraph (1).
                    ``(B) Further manufacturing use.--No fee shall be 
                required under paragraph (1) for the submission of a 
                premarket application under section 351 of the Public 
                Health Service Act for a product licensed for further 
                manufacturing use only.
                    ``(C) State or federal government sponsors.--No fee 
                shall be required under paragraph (1) for a premarket 
                application, premarket report, supplement, or premarket 
                notification submission submitted by a State or Federal 
                Government entity unless the device involved is to be 
                distributed commercially.
                    ``(D) Premarket notifications by third parties.--No 
                fee shall be required under paragraph (1) for a 
                premarket notification submission reviewed by an 
                accredited person pursuant to section 523.
                    ``(E) Pediatric conditions of use.--
                            ``(i) In general.--No fee shall be required 
                        under paragraph (1) for a premarket 
                        application, premarket report, or premarket 
                        notification submission if the proposed 
                        conditions of use for the device involved are 
                        solely for a pediatric population. No fee shall 
                        be required under such subparagraph for a 
                        supplement if the sole purpose of the 
                        supplement is to propose conditions of use for 
                        a pediatric population.
                            ``(ii) Subsequent proposal of adult 
                        conditions of use.--In the case of a person who 
                        submits a premarket application or premarket 
                        report for which, under clause (i), a fee under 
                        paragraph (1) is not required, any supplement 
                        to such application that proposes conditions of 
                        use for any adult population is subject to the 
                        fee that applies under such subparagraph for a 
                        premarket application.
            ``(3) Payment.--The fee required by paragraph (1) shall be 
        due upon submission of the premarket application, premarket 
        report, supplement, or premarket notification submission, 
        except that invoices for applications submitted on or after 
        October 1, 2002, and before the date on which appropriations 
        under subsection (h)(3) for fiscal year 2003 first become 
        available shall be payable within 30 days of the issuance of 
        such invoices. Applicants submitting portions of applications 
        pursuant to section 515(c)(3) shall pay such fees upon 
        submission of the first portion of such applications. The fees 
        credited to fiscal year 2003 under this section shall include 
all fees payable from October 1, 2002, through September 30, 2003.
            ``(4) Refunds.--
                    ``(A) Application refused for filing.--The 
                Secretary shall refund 75 percent of the fee paid under 
                paragraph (1) for any application, report, or 
                supplement that is refused for filing.
                    ``(B) Application withdrawn before filing.--The 
                Secretary shall refund 75 percent of the fee paid under 
                paragraph (1) for any application, report, or 
                supplement that is withdrawn prior to the filing 
                decision of the Secretary.
                    ``(C) Application withdrawn before first action.--
                After receipt of a request for a refund of the fee paid 
                under paragraph (1) for a premarket application, 
                premarket report, or supplement that is withdrawn after 
                filing but before a first action, the Secretary may 
                return some or all of the fee. The amount of refund, if 
                any, shall be based on the level of effort already 
                expended on the review of such application, report, or 
                supplement. The Secretary shall have sole discretion to 
                refund a fee or portion of the fee under this 
                subparagraph. A determination by the Secretary 
                concerning a refund under this paragraph shall not be 
                reviewable.''.
            (2) Other corrections relating to fees.--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--
                    (A) in section 737--
                            (i) in paragraph (4)--
                                    (I) in subparagraph (B), by 
                                striking ``and for which'' and all that 
                                follows and inserting the following: 
                                ``and for which substantial clinical 
                                data are necessary to provide a 
                                reasonable assurance of safety and 
                                effectiveness.''; and
                                    (II) in subparagraph (D), by 
                                striking ``manufacturing,'';
                            (ii) in paragraph (5)(J), by striking ``a 
                        premarket application'' and all that follows 
                        and inserting the following: ``a premarket 
                        application or premarket report under section 
                        515 or a premarket application under section 
                        351 of the Public Health Service Act.''; and
                            (iii) in paragraph (8), in the matter 
                        preceding subparagraph (A), by inserting 
                        ``(whether domestic or international)'' after 
                        ``second business entity''; and
                    (B) in section 738--
                            (i) in subsection (d)(2)(B), beginning in 
                        the second sentence, by striking ``firms. which 
                        show'' and inserting ``firms, which show'';
                            (ii) 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)--
                                            (aa) in subparagraph (B), 
                                        beginning in the second 
                                        sentence, by striking ``firms. 
                                        which show'' and inserting 
                                        ``firms, which show''; and
                                            (bb) in subparagraph 
                                        (C)(i), by striking ``Where'' 
                                        and inserting ``For fiscal year 
                                        2004 and each subsequent fiscal 
                                        year, where'';
                            (iii) in subsection (f), by striking ``for 
                        filing'' and inserting ``for review''; and
                            (iv) in subsection (h)(2)--
                                    (I) in subparagraph (A), by 
                                striking clause (ii) and inserting the 
                                following:
                            ``(ii) shall only be collected and 
                        available to defray increases in the costs of 
                        the resources allocated for the purposes for 
                        the review of device applications (including 
                        increases in such costs for an additional 
                        number of full-time equivalent positions in the 
                        Department of Health and Human Services to be 
                        engaged in such process) over such costs for 
                        fiscal year 2002 when multiplied by the 
                        adjustment factor.
                For purposes of this subparagraph, the determination of 
                the costs of the resources allocated for the process 
                for the review of device applications for fiscal year 
                2003 through 2007 shall not include costs paid from 
                fees collected under this section.''; and
                                    (II) in subparagraph (B), by 
                                inserting after and below clause 
                                (ii)((II) the following:
                ``To the extent such costs are more than 5 percent 
                below the level specified 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 the following: ``conducting 
                inspections of establishments that manufacture, 
                prepare, propagate, compound, or process class II or 
                class III devices, which inspections are required in 
                section 510(h) or are inspections of such 
                establishments required to register under section 
                510(i).'';
                    (B) in paragraph (6)(A)--
                            (i) in the matter preceding clause (i), by 
                        inserting ``during a two-year period'' after 
                        ``paragraph (2)'';
                            (ii) in clause (i), by striking ``most 
                        recent inspection'' and all that follows 
                        through ``section 510 as'' and inserting ``most 
                        recent inspection described in paragraph (1) 
                        as'';
                            (iii) in clause (ii)--
                                    (I) in the matter preceding 
                                subclause (I), by striking ``With 
                                respect to'' and all that follows and 
                                inserting the following: ``With respect 
                                to the inspections to be conducted by 
                                an accredited person during such two-
                                year period--'';
                                    (II) in subclause (I), by striking 
                                ``such a person to conduct the 
                                inspection,'' and inserting ``an 
                                accredited person to conduct the 
                                inspections,''; and
                                    (III) in subclause (II), by 
                                striking ``the inspection,'' and 
                                inserting ``the inspections,'';
                            (iv) in clause (iii)--
                                    (I) in the matter preceding 
                                subclause (I), by striking ``United 
                                States,'' and all that follows and 
                                inserting ``United States, and--'';
                                    (II) in subclause (I)--
                                            (aa) by striking ``At least 
                                        one'' and inserting ``at least 
                                        one''; and
                                            (bb) by striking 
                                        ``identified under subclause 
                                        (II) of this clause.'' and 
                                        inserting ``identified under 
                                        clause (ii)(II); or''; and
                                    (III) in subclause (II), by 
                                striking ``The owner'' and inserting 
                                ``the owner''; and
                            (v) in clause (iv)--
                                    (I) in subclause (I), in the first 
                                sentence, by striking ``In the case 
                                of'' and all that follows through 
                                ``except that'' and inserting the 
                                following: ``In the case of inspections 
                                to be conducted pursuant to section 
                                510(h), persons accredited under 
                                paragraph (2) did not conduct any 
                                inspection of the establishment during 
                                the two preceding two-year periods 
                                referred to in such section with 
                                respect to the establishment, except 
                                that'';
                            (II) in subclause (II), by striking ``In 
                        the case of'' and all that follows through 
                        ``the Secretary'' and inserting the following: 
                        ``In the case of inspections to be conducted of 
                        a device establishment required to register 
                        under section 510(i), the Secretary'';
                    (C) in paragraph (6)(B)--
                            (i) in clause (iii)--
                                    (I) by striking ``and data 
                                otherwise'' in the first sentence and 
                                all that follows through ``reports of 
                                inspections regarding'' in the second 
                                sentence and inserting the following: 
                                ``and data describing compliance with 
                                other applicable provisions of this 
                                Act. Such data shall include reports of 
                                inspectional findings regarding''; and
                                    (II) in the second sentence, by 
                                striking ``establishment, together 
                                with'' and all that follows and 
                                inserting ``establishment.''; and
                            (ii) in clause (v), by adding at the end 
                        the following subclause:
            ``(III) The agreement (or deemed agreement) of the 
        Secretary under this subparagraph to the selection of an 
        accredited person is effective for the two-year period referred 
        to in the matter preceding clause (i) of subparagraph (A), 
        subject to paragraph (5)(B).'';
                    (D) in paragraph (6)(C)(ii), in the last sentence, 
                by inserting before the period the following: ``and may 
                submit a notice under subparagraph (A)'';
                    (E) in paragraph (10)(B)(iii), by striking ``a 
                reporting'' and inserting ``a report''; and
                    (F) in paragraph (12)--
                            (i) in subparagraph (A), by striking ``the 
                        number of'' the first place such term appears 
                        and all that follows and inserting the 
                        following: ``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.--Chapter V of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by 
        sections 204 and 206 of Public Law 107-250 (116 Stat. 1611, 
        1613), is amended--
                    (A) in section 502(f), in the last sentence--
                            (i) by striking ``requirements of law and, 
                        that'' and inserting ``requirements of law, 
                        that''; and
                            (ii) by striking ``and after such request, 
                        promptly provides'' and inserting ``and that, 
                        after receiving such request, the manufacturer 
                        promptly provides''; and
                    (B) in section 503(g)(4)(A), in the second 
                sentence, by striking ``shall, in determining whether'' 
                and all that follows through ``consult'' and inserting 
                the following: ``shall, in determining whether the 
                product to be assigned is appropriately classified as a 
combination product, consult''.
    (c) Title III; Additional Amendments.--
            (1) In general.--The Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 301 et seq.), as amended by sections 301 and 302 of 
        Public Law 107-250 (116 Stat. 1616), is amended--
                    (A) in section 502 (21 U.S.C. 352)--
                            (i) by striking paragraph (u); and
                            (ii) by redesignating paragraph (v) as 
                        paragraph (u); and
                    (B) in section 510(o) (21 U.S.C. 360(o))--
                            (i) in paragraph (1)(B), in the third 
                        sentence, by striking ``misbranded under 
                        section 502(o), adulterated under'' and 
                        inserting ``misbranded under section 502(o) or 
                        adulterated under''; and
                            (ii) in paragraph (2)--
                                    (I) in subparagraph (B), in the 
                                third sentence, by striking 
                                ``misbranded under section 502(o), 
                                adulterated under'' and inserting 
                                ``misbranded under section 502(o) or 
                                adulterated under''; and
                                    (II) in subparagraph (E), by 
                                striking ``semicritical'' and inserting 
                                ``semi-critical''.
            (2) Conforming amendment.--Section 301 of Public Law 107-
        250 (116 Stat. 1616) is amended by striking subsection (b).
    (d) Miscellaneous Corrections.--
            (1) Certain amendments regarding section 515(c).--
                    (A) In general.--Section 515(c) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 360e), as 
                amended by sections 209 and 302(c)(2)(A) of Public Law 
                107-250 (116 Stat. 1613, 1618), is amended--
                            (i) by redesignating the second paragraph 
                        (3) (added by section 209 of such Public Law) 
                        as paragraph (4); and
                            (ii) in paragraph (4) (as so redesignated), 
                        in subparagraph (B), by striking ``an issue'' 
                        and inserting ``a new issue''.
                    (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 the following: ``is amended in paragraph 
                (3), as redesignated by section 302(c)(2)(A) of this 
                Act, by adding''.
            (2) Conforming amendments regarding references to section 
        738(a).--
                    (A) In general.--Section 738 of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by 
                subparagraph (A) of this paragraph, is amended--
                            (i) in subsection (d)(1), in the last 
                        sentence, by striking ``clauses (i) through 
                        (vi) of subsection (a)(1)(A)'' and inserting 
                        ``subparagraphs (A) through (F) of subsection 
                        (a)(1)'';
                            (ii) in subsection (e)(1), by striking 
                        ``subsection (a)(1)(A)(vii)'' and inserting 
                        ``subsection (a)(1)(G)'';
                            (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)(1)(G)''; and
                                    (II) in clause (ii), by striking 
                                ``subsection (a)(1)(A)(i)'' and 
                                inserting ``subsection (a)(1)(A)''; and
                            (iv) in subsection (j), by striking 
                        ``subsection (a)(1)(D),'' and inserting 
                        ``subsection (a)(4),''.
                    (B) 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)(1)(B)''.
            (3) Public law 107-250.--Public Law 107-250 is amended--
                    (A) in section 102--
                            (i) in subsection (a) (116 Stat. 1589), by 
                        striking ``(21 U.S.C. 379F et seq.)'' and 
                        inserting ``(21 U.S.C. 379f et seq.)''; and
                            (ii) in subsection (b) (116 Stat. 1600), by 
                        striking paragraph (2);
                    (B) in section 212(b)(2) (116 Stat. 1614), by 
                striking ``medical devices, such as phase IV trials, 
                and'' and inserting ``medical devices and''; and
                    (C) in section 214(a)(3) (116 Stat. 1615), by 
                striking ``discussion'' and inserting ``presentation''.
            (4) Public health service act.--Section 498C of the Public 
        Health Service Act (42 U.S.C. 289g-3), as added by section 
        215(b) of Public Law 107-250 (116 Stat. 1615), is amended in 
        subsection (a) by striking ``Director of NIH may'' and 
        inserting ``Director of NIH shall''.
    (e) Humanitarian Device Exemption; Pediatric Patients.--Section 
520(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(m)(3)) is amended--
            (1) by striking ``(3) No person'' and inserting ``(3)(A) 
        Except as provided in subparagraph (B), no person''; and
            (2) by adding at the end the following:
    ``(B)(i) Subparagraph (A) does not apply with respect to any device 
intended for the treatment or diagnosis of a pediatric condition.
    ``(ii) For purposes of this subsection:
            ``(I) The term `pediatric condition' means a disease, 
        disorder, or other condition unique to, more serious, or more 
        prevalent in pediatric patients.
            ``(II) The term `pediatric patient' means a patient who is 
        under 15 years of age at the time of diagnosis or treatment.''.
                                 <all>