[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1881 Reported in Senate (RS)]






                                                       Calendar No. 412
108th CONGRESS
  1st Session
                                S. 1881

  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 SENATE OF THE UNITED STATES

                           November 18, 2003

   Mr. Alexander (for himself, Mrs. Murray, Mr. Gregg, and Mr. Enzi) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

                           November 24, 2003

                Reported by Mr. Gregg, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Medical Devices Technical 
Corrections Act''.</DELETED>

<DELETED>SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 107-
              250.</DELETED>

<DELETED>    (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--</DELETED>
        <DELETED>    (1) in section 737--</DELETED>
                <DELETED>    (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'';</DELETED>
                <DELETED>    (B) in paragraph (4)(D), by striking 
                ``manufacturing,'';</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (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</DELETED>
        <DELETED>    (2) in section 738--</DELETED>
                <DELETED>    (A) in subsection (a)(1)--</DELETED>
                        <DELETED>    (i) in subparagraph (A)--
                        </DELETED>
                                <DELETED>    (I) in the matter 
                                preceding clause (i) by striking 
                                ``subsection (d),'' and inserting 
                                ``subsections (d) and (e),'';</DELETED>
                                <DELETED>    (II) in clause (iv), by 
                                striking ``clause (i),'' and all that 
                                follows and inserting ``clause (i).''; 
                                and</DELETED>
                                <DELETED>    (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</DELETED>
                        <DELETED>    (ii) in subparagraph (D), in each 
                        of clauses (i) and (ii), by striking 
                        ``application'' and inserting ``application, 
                        report,'';</DELETED>
                <DELETED>    (B) in subsection (d)(2)(B), beginning in 
                the second sentence, by striking ``firms. which show'' 
                and inserting ``firms, which show'';</DELETED>
                <DELETED>    (C) in subsection (e)--</DELETED>
                        <DELETED>    (i) in paragraph (1), by striking 
                        ``Where'' and inserting ``For fiscal year 2004 
                        and each subsequent fiscal year, where''; 
                        and</DELETED>
                        <DELETED>    (ii) in paragraph (2)--</DELETED>
                                <DELETED>    (I) in subparagraph (B), 
                                beginning in the second sentence, by 
                                striking ``firms. which show'' and 
                                inserting ``firms, which show''; 
                                and</DELETED>
                                <DELETED>    (II) in subparagraph 
                                (C)(i), by striking ``Where'' and 
                                inserting ``For fiscal year 2004 and 
                                each subsequent fiscal year, 
                                where'';</DELETED>
                <DELETED>    (D) in subsection (f), by striking ``for 
                filing''; and</DELETED>
                <DELETED>    (E) in subsection (h)(2)--</DELETED>
                        <DELETED>    (i) by striking subparagraph 
                        (A)(ii) and inserting the following:</DELETED>
                        <DELETED>    ``(ii) shall only be collected and 
                        available to defray increases in the costs of 
                        the resources allocated for the process 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 (the determination of the 
                        costs of the resources allocated for the 
                        process for the review of device applications 
                        for fiscal year 2003 through 2007, for purposes 
                        of this subparagraph, shall not include costs 
                        paid from fees collected under this 
                        section).''; and</DELETED>
                        <DELETED>    (ii) in subparagraph (B)--
                        </DELETED>
                                <DELETED>    (I) in clause (ii), by 
                                redesignating subclauses (I) and (II) 
                                as items (aa) and (bb), 
                                respectively;</DELETED>
                                <DELETED>    (II) by redesignating 
                                clauses (i) and (ii) as subclauses (I) 
                                and (II), respectively;</DELETED>
                                <DELETED>    (III) by striking ``The 
                                Secretary'' and inserting the 
                                following:</DELETED>
                        <DELETED>    ``(i) In general.--The 
                        Secretary''; and</DELETED>
                                <DELETED>    (IV) by adding at the end 
                                the following:</DELETED>
                        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (b) Title II; Amendments Regarding Regulation of Medical 
Devices.--</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (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).'';</DELETED>
                <DELETED>    (B) in paragraph (6)(A)--</DELETED>
                        <DELETED>    (i) in clause (i), by striking 
                        ``of the establishment pursuant to subsection 
                        (h) or (i) of section 510'' and inserting 
                        ``described in paragraph (1)'';</DELETED>
                        <DELETED>    (ii) in clause (ii)--</DELETED>
                                <DELETED>    (I) in the matter 
                                preceding subclause (I)--</DELETED>
                                        <DELETED>    (aa) by striking 
                                        ``each inspection'' and 
                                        inserting ``inspections''; 
                                        and</DELETED>
                                        <DELETED>    (bb) by inserting 
                                        ``during a 2-year period'' 
                                        after ``person''; and</DELETED>
                                <DELETED>    (II) in subclause (I), by 
                                striking ``such a person'' and 
                                inserting ``an accredited 
                                person'';</DELETED>
                        <DELETED>    (iii) in clause (iii)--</DELETED>
                                <DELETED>    (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:'';</DELETED>
                                <DELETED>    (II) in subclause (I), by 
                                striking ``under subclause (II) of this 
                                clause'' and inserting ``under clause 
                                (ii)(II)''; and</DELETED>
                                <DELETED>    (III) in subclause (II), 
                                by inserting ``or by a person 
                                accredited under paragraph (2)'' after 
                                ``by the Secretary'';</DELETED>
                        <DELETED>    (iv) in clause (iv)(I)--</DELETED>
                                <DELETED>    (I) in the first 
                                sentence--</DELETED>
                                        <DELETED>    (aa) by striking 
                                        ``the two immediately preceding 
                                        inspections of the 
                                        establishment'' and inserting 
                                        ``inspections of the 
                                        establishment during the 
                                        previous 4 years''; 
                                        and</DELETED>
                                        <DELETED>    (bb) by inserting 
                                        ``section'' after ``pursuant 
                                        to''; and</DELETED>
                                <DELETED>    (II) in the third 
                                sentence--</DELETED>
                                        <DELETED>    (aa) by striking 
                                        ``the petition states a 
                                        commercial reason for the 
                                        waiver;''; and</DELETED>
                                        <DELETED>    (bb) by inserting 
                                        ``not'' after ``the Secretary 
                                        has not determined that the 
                                        public health would''; 
                                        and</DELETED>
                        <DELETED>    (v) in clause (iv)(II)--</DELETED>
                                <DELETED>    (I) by inserting ``of a 
                                device establishment required to 
                                register'' after ``to be conducted''; 
                                and</DELETED>
                                <DELETED>    (II) by inserting 
                                ``section'' after ``pursuant 
                                to'';</DELETED>
                <DELETED>    (C) in paragraph (6)(B)(iii)--</DELETED>
                        <DELETED>    (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</DELETED>
                        <DELETED>    (ii) in the second sentence--
                        </DELETED>
                                <DELETED>    (I) by striking 
                                ``inspections'' and inserting 
                                ``inspectional findings''; 
                                and</DELETED>
                                <DELETED>    (II) by striking ``, 
                                together with all other compliance data 
                                the Secretary deems 
                                necessary'';</DELETED>
                <DELETED>    (D) 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'';</DELETED>
                <DELETED>    (E) in paragraph (10)(B)(iii), by striking 
                ``a reporting'' and inserting ``a report''; 
                and</DELETED>
                <DELETED>    (F) in paragraph (12)--</DELETED>
                        <DELETED>    (i) by striking subparagraph (A) 
                        and inserting the following:</DELETED>
                <DELETED>    ``(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</DELETED>
                        <DELETED>    (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;''.</DELETED>
        <DELETED>    (2) Other corrections.--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--</DELETED>
                <DELETED>    (A) 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'';</DELETED>
                <DELETED>    (B) by inserting a comma after 
                ``means'';</DELETED>
                <DELETED>    (C) by striking ``requirements of law and, 
                that'' and inserting ``requirements of law, and 
                that'';</DELETED>
                <DELETED>    (D) by striking ``the manufacturer affords 
                health care facilities the opportunity'' and inserting 
                ``the manufacturer affords such users the 
                opportunity''; and</DELETED>
                <DELETED>    (E) by striking ``the health care 
                facility''.</DELETED>
<DELETED>    (c) Title III; Additional Amendments.--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--
</DELETED>
        <DELETED>    (1) in paragraph (1)(B), by striking ``, 
        adulterated'' and inserting ``or adulterated''; and</DELETED>
        <DELETED>    (2) in paragraph (2)--</DELETED>
                <DELETED>    (A) in subparagraph (B), by striking ``, 
                adulterated'' and inserting ``or adulterated''; 
                and</DELETED>
                <DELETED>    (B) in subparagraph (E), by striking 
                ``semicritical'' and inserting ``semi-
                critical''.</DELETED>
<DELETED>    (d) Miscellaneous Corrections.--</DELETED>
        <DELETED>    (1) Certain amendments to section 515.--</DELETED>
                <DELETED>    (A) In general.--</DELETED>
                        <DELETED>    (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).</DELETED>
                        <DELETED>    (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''.</DELETED>
                <DELETED>    (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''.</DELETED>
        <DELETED>    (2) Certain amendments to section 738.--</DELETED>
                <DELETED>    (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--
                </DELETED>
                        <DELETED>    (i) in the matter preceding 
                        paragraph (1)--</DELETED>
                                <DELETED>    (I) by striking ``(a) 
                                Types of Fees.--Beginning on'' and 
                                inserting the following:</DELETED>
<DELETED>    ``(a) Types of Fees.--</DELETED>
        <DELETED>    ``(1) In general.--Beginning on''; and</DELETED>
                                <DELETED>    (II) by striking ``this 
                                section as follows:'' and inserting 
                                ``this section.''; and</DELETED>
                        <DELETED>    (ii) by striking ``(1) Premarket 
                        application,'' and inserting the following: 
                        ``(2) Premarket application,''.</DELETED>
                <DELETED>    (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--
                </DELETED>
                        <DELETED>    (i) in subsection (d)(1), in the 
                        last sentence, by striking ``subsection 
                        (a)(1)(A)'' and inserting ``subsection 
                        (a)(2)(A)'';</DELETED>
                        <DELETED>    (ii) in subsection (e)(1), by 
                        striking ``subsection (a)(1)(A)(vii)'' and 
                        inserting ``subsection 
                        (a)(2)(A)(vii)'';</DELETED>
                        <DELETED>    (iii) in subsection (e)(2)(C)--
                        </DELETED>
                                <DELETED>    (I) in each of clauses (i) 
                                and (ii), by striking ``subsection 
                                (a)(1)(A)(vii)'' and inserting 
                                ``subsection (a)(2)(A)(vii)''; 
                                and</DELETED>
                                <DELETED>    (II) in clause (ii), by 
                                striking ``subsection (a)(1)(A)(i)'' 
                                and inserting ``subsection 
                                (a)(2)(A)(i)''; and</DELETED>
                        <DELETED>    (iv) in subsection (j), by 
                        striking ``subsection (a)(1)(D),'' and 
                        inserting ``subsection (a)(2)(D),''.</DELETED>
                <DELETED>    (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)''.</DELETED>
        <DELETED>    (3) Public law 107-250.--Public Law 107-250 is 
        amended--</DELETED>
                <DELETED>    (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.)'';</DELETED>
                <DELETED>    (B) in section 102(b) (116 Stat. 1600)--
                </DELETED>
                        <DELETED>    (i) by striking paragraph 
                        (2);</DELETED>
                        <DELETED>    (ii) in paragraph (1), by 
                        redesignating subparagraphs (A) and (B) as 
                        paragraphs (1) and (2), respectively; 
                        and</DELETED>
                        <DELETED>    (iii) by striking:</DELETED>
<DELETED>    ``(b) Fee Exemption for Certain Entities Submitting 
Premarket Reports.--</DELETED>
        <DELETED>    ``(1) In general.--A person submitting a premarket 
        report'' and inserting:</DELETED>
<DELETED>    ``(b) Fee Exemption for Certain Entities Submitting 
Premarket Reports.--A person submitting a premarket report'';</DELETED>
                <DELETED>    (C) in section 212(b)(2) (116 Stat. 1614), 
                by striking ``, such as phase IV trials,''; 
                and</DELETED>
                <DELETED>    (D) in section 301(b) (116 Stat. 1616), by 
                striking ``18 months'' and inserting ``36 
                months''.</DELETED>

<DELETED>SEC. 3. HUMANITARIAN DEVICE EXEMPTION AND PEDIATRIC 
              PRODUCTS.</DELETED>

<DELETED>    (a) Amendment to Federal Food, Drug, and Cosmetic Act.--
Section 520(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j(m)(3)) is amended to read as follows:</DELETED>
<DELETED>    ``(3) Excluding devices intended for the treatment or 
diagnosis of diseases or conditions that affect pediatric patients, no 
person granted an exemption under paragraph (2) with respect to a 
device may sell the device for an amount that exceeds the costs of 
research and development, fabrication, and distribution of the device. 
The exclusion from the prohibition under the previous sentence for 
devices intended for the treatment or diagnosis of diseases or 
conditions that affect pediatric patients, shall not apply in the case 
of a request for an exemption under paragraph (2) made on or after 
October 1, 2007. In this paragraph, the term `pediatric patient' means 
a patient who is 14 years of age or younger at the time of diagnosis or 
treatment.''.</DELETED>
<DELETED>    (b) Report.--Not later than October 1, 2006, the 
Comptroller General of the United States, in consultation with the 
Secretary of Health and Human Services, shall submit to Congress a 
report that addresses the effectiveness of section 520(m) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) in ensuring 
the development of devices designed to treat or diagnose diseases or 
conditions that affect fewer than 4,000 pediatric patients in the 
United States. Such report shall include the number and importance of 
devices for pediatric patients that are receiving exemptions under 
section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(m)).</DELETED>

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 (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 
                                ``under subclause (II) of this clause'' 
                                and inserting ``under clause 
                                (ii)(II)''; 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'';
                    (C) 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
                            (ii) in the second sentence--
                                    (I) by striking ``inspections'' and 
                                inserting ``inspectional findings''; 
                                and
                                    (II) by inserting ``relevant'' 
                                after ``together with all other'';
                    (D) 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'';
                    (E) in paragraph (10)(B)(iii), by striking ``a 
                reporting'' and inserting ``a report''; and
                    (F) 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.




                                                       Calendar No. 412

108th CONGRESS

  1st Session

                                S. 1881

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                           November 24, 2003

                       Reported with an amendment