[Congressional Record Volume 149, Number 174 (Tuesday, November 25, 2003)]
[Senate]
[Pages S16057-S16060]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




               MEDICAL DEVICES TECHNICAL CORRECTIONS ACT

  Mr. McCONNELL. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of Calendar No. 412, S. 1881.

[[Page S16058]]

  The PRESIDING OFFICER. The clerk will report the bill by title.
  The assistant legislative clerk read as follows:

       A bill (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.

  There being no objection, the Senate proceeded to consider the bill, 
which had been reported from the Committee on Health, Education, Labor, 
and Pensions, with an amendment to strike all after the enacting clause 
and inserting in lieu thereof the following:
  [Strike the part shown in black brackets and insert the part shown in 
italic.]

                                S. 1881

       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''.

     [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)--
       [(i) by striking subparagraph (A)(ii) and inserting the 
     following:
       [``(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
       [(ii) in subparagraph (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''; and

       [(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
       [(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 striking ``, together with all other compliance 
     data the Secretary deems necessary'';

       [(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.--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--
       [(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'';
       [(B) by inserting a comma after ``means'';
       [(C) by striking ``requirements of law and, that'' and 
     inserting ``requirements of law, and that'';
       [(D) by striking ``the manufacturer affords health care 
     facilities the opportunity'' and inserting ``the manufacturer 
     affords such users the opportunity''; and
       [(E) by striking ``the health care facility''.
       [(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--
       [(1) in paragraph (1)(B), by striking ``, adulterated'' and 
     inserting ``or adulterated''; and
       [(2) in paragraph (2)--
       [(A) in subparagraph (B), by striking ``, adulterated'' and 
     inserting ``or adulterated''; and
       [(B) 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

[[Page S16059]]

     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'';
       [(C) in section 212(b)(2) (116 Stat. 1614), by striking ``, 
     such as phase IV trials,''; and
       [(D) in section 301(b) (116 Stat. 1616), by striking ``18 
     months'' and inserting ``36 months''.

     [SEC. 3. HUMANITARIAN DEVICE EXEMPTION AND PEDIATRIC 
                   PRODUCTS.

       [(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:
       [``(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.''.
       [(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)).]

     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

[[Page S16060]]

       (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.

  Mr. McCONNELL. Mr. President, I ask unanimous consent that the 
committee substitute amendment be agreed to, the bill, as amended, be 
read a third time and passed, the motion to reconsider be laid upon the 
table, and that any statements relating to the bill be printed in the 
Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The committee amendment in the nature of a substitute was agreed to.
  The bill (S. 1881), as amended, was read the third time and passed.

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