Text: S.2289 — 112th Congress (2011-2012)

There is one version of the bill.

Bill text available as:

Shown Here:
Introduced in Senate (04/17/2012)


Formatting necessary for an accurate reading of this legislative text may be shown by tags (e.g., <DELETED> or <BOLD>) or may be missing from this TXT display. For complete and accurate display of this text, see the PDF or HTML/XML.




[Congressional Bills 112th Congress]
[From the U.S. Government Printing Office]
[S. 2289 Introduced in Senate (IS)]

112th CONGRESS
  2d Session
                                S. 2289

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                         pediatric provisions.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 17, 2012

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

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                         pediatric provisions.

    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 ``Better Pharmaceuticals and Devices 
for Children Act of 2012''.

SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.

    (a) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.
Sec. 3. Permanence.
Sec. 4. Written requests.
Sec. 5. Communication with Pediatric Review Committee.
Sec. 6. Access to data.
Sec. 7. Ensuring the completion of pediatric studies.
Sec. 8. Pediatric study plans.
Sec. 9. Reauthorizations.
Sec. 10. Report.
Sec. 11. Technical amendments.
    (b) References in Act.--Except as otherwise specified, amendments 
made by this Act to a section or other provision of law are amendments 
to such section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 3. PERMANENCE.

    (a) Pediatric Studies of Drugs.--Subsection (q) of section 505A (21 
U.S.C. 355a) is amended--
            (1) in paragraph (1), by striking ``on or before October 1, 
        2012,''; and
            (2) in paragraph (2), by striking ``on or before October 1, 
        2012,''.
    (b) Research Into Pediatric Uses for Drugs and Biological 
Products.--Section 505B (21 U.S.C. 355c) is amended--
            (1) by striking subsection (m); and
            (2) by redesignating subsection (n) as subsection (m).

SEC. 4. WRITTEN REQUESTS.

    (a) Federal Food, Drug, and Cosmetic Act.--Subsection (h) of 
section 505A (21 U.S.C. 355a) is amended to read as follows:
    ``(h) Relationship to Pediatric Research Requirements.--Exclusivity 
under this section shall only be granted for the completion of a study 
or studies that are the subject of a written request and for which 
reports are submitted and accepted in accordance with subsection 
(d)(3). Written requests under this section may consist of a study or 
studies required under section 505B.''.
    (b) Public Health Service Act.--Section 351(m) of the Public Health 
Service Act (42 U.S.C. 262(m)) is amended by striking ``(f), (i), (j), 
(k), (l), (p), and (q)'' and inserting ``(f), (h), (i), (j), (k), (l), 
and (p)''.

SEC. 5. COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE.

    Not later than 1 year after the date of enactment of this Act, the 
Secretary of Health and Human Services (referred to in this Act as the 
``Secretary'') shall issue internal standard operating procedures that 
provide for the review by the internal review committee established 
under section 505C of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355d) of any significant modifications to initial pediatric 
study plans, agreed pediatric study plans, and written requests under 
sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c). Such internal standard operating procedures shall be made 
publicly available on the Internet Web site of the Food and Drug 
Administration.

SEC. 6. ACCESS TO DATA.

    Not later than 3 years after the date of enactment of this Act, the 
Secretary shall make available to the public, including through posting 
on the Internet Web site of the Food and Drug Administration, the 
medical, statistical, and clinical pharmacology reviews of, and 
corresponding written requests issued to an applicant, sponsor, or 
holder for, pediatric studies submitted between January 4, 2002, and 
September 27, 2007, under subsection (b) or (c) of section 505A of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6 
months of market exclusivity was granted and that resulted in a 
labeling change. The Secretary shall make public the information 
described in the preceding sentence in a manner consistent with how the 
Secretary releases information under section 505A(k) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)).

SEC. 7. ENSURING THE COMPLETION OF PEDIATRIC STUDIES.

    (a) Extension of Deadline for Deferred Studies.--Section 505B (21 
U.S.C. 355c) is amended--
            (1) in subsection (a)(3)--
                    (A) by redesignating subparagraph (B) as 
                subparagraph (C);
                    (B) by inserting after subparagraph (A) the 
                following:
                    ``(B) Deferral extension.--
                            ``(i) In general.--On the initiative of the 
                        Secretary or at the request of the applicant, 
                        the Secretary may grant an extension of a 
                        deferral approved under subparagraph (A) for 
                        submission of some or all assessments required 
                        under paragraph (1) if--
                                    ``(I) the Secretary determines that 
                                the conditions described in subclause 
                                (II) or (III) of subparagraph (A)(i) 
                                continue to be met; and
                                    ``(II) the applicant submits a new 
                                timeline under subparagraph (A)(ii)(IV) 
                                and any significant updates to the 
                                information required under subparagraph 
                                (A)(ii).
                            ``(ii) Timing and information.--If the 
                        deferral extension under this subparagraph is 
                        requested by the applicant, the applicant shall 
                        submit the deferral extension request 
                        containing the information described in this 
                        subparagraph not less than 90 days prior to the 
                        date that the deferral would expire but for the 
                        requested extension. The Secretary shall 
                        respond to such request not later than 45 days 
                        after the receipt of such letter. If the 
                        Secretary grants such an extension, the 
                        specified date shall be considered the extended 
                        date. The sponsor of the required assessment 
                        under paragraph (1) shall not be issued a 
                        letter described in subsection (d) unless the 
                        specified date of submission for such required 
                        studies has passed or if the request for an 
                        extension is pending. For a deferral that has 
                        expired prior to the date of enactment of the 
                        Better Pharmaceuticals and Devices for Children 
                        Act of 2012 or that will expire prior to 270 
                        days after the date of enactment of such Act, a 
                        deferral extension shall be requested by an 
                        applicant not later than 180 days after the 
                        date of enactment of such Act. Nothing in this 
                        clause shall prevent the Secretary from 
                        updating the status of a study or studies 
                        publicly if components of such study or studies 
                        are late or delayed.''; and
                    (C) in subparagraph (C), as so redesignated--
                            (i) in clause (i), by adding at the end the 
                        following:
                                    ``(III) Projected completion date 
                                for pediatric studies.
                                    ``(IV) The reason or reasons why a 
                                deferral or deferral extension 
                                continues to be necessary.''; and
                            (ii) in clause (ii)--
                                    (I) by inserting ``, as well as the 
                                date of each deferral or deferral 
                                extension, as applicable,'' after 
                                ``clause (i)''; and
                                    (II) by inserting ``not later than 
                                60 days after submission to the 
                                Secretary'' after ``Administration''; 
                                and
            (2) in subsection (f)--
                    (A) in the subsection heading, by inserting 
                ``Deferral Extensions,'' after ``Deferrals,'';
                    (B) in paragraph (1), by inserting ``, deferral 
                extension,'' after ``deferral''; and
                    (C) in paragraph (4), by inserting ``, deferral 
                extensions,'' after ``deferrals''.
    (b) Tracking of Extensions; Annual Information.--Section 
505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as follows:
                    ``(D) aggregated on an annual basis--
                            ``(i) the total number of deferrals and 
                        deferral extensions requested and granted under 
                        this section and, if granted, the reasons for 
                        each such deferral or deferral extension;
                            ``(ii) the timeline for completion of the 
                        assessments; and
                            ``(iii) the number of assessments completed 
                        and pending by the specified date, as outlined 
                        in subsection (a)(3);''.
    (c) Action on Failure To Complete Studies.--
            (1) Issuance of letter.--Subsection (d) of section 505B (21 
        U.S.C. 355c) is amended to read as follows:
    ``(d) Submission of Assessments.--If a person fails to submit a 
required assessment described in subsection (a)(2), fails to meet the 
applicable requirements in subsection (a)(3), or fails to submit a 
request for approval of a pediatric formulation described in subsection 
(a) or (b), in accordance with applicable provisions of subsections (a) 
and (b), the following shall apply:
            ``(1) Beginning 270 days after the date of enactment of the 
        Better Pharmaceuticals and Devices for Children Act of 2012, 
        the Secretary shall issue a letter to such person informing 
        them of such failure to submit or meet the applicable 
        subsection. Such letter shall require the person to respond in 
        writing within 45 calendar days of issuance of such letter. 
        Such response may include the person's request for a deferral 
        extension if applicable. Such letter and the person's written 
        response to such letter shall be made publicly available on the 
        Internet Web site of the Food and Drug Administration 45 
        calendar days after issuance, with redactions for any trade 
        secrets and confidential commercial information. If the 
        Secretary determines that the letter was issued in error, the 
        requirements of this paragraph shall not apply.
            ``(2) The drug or biological product that is the subject of 
        an assessment described in subsection (a)(2), applicable 
        requirements in subsection (a)(3), or request for approval of a 
        pediatric formulation, may be considered misbranded solely 
        because of that failure and subject to relevant enforcement 
        action (except that the drug or biological product shall not be 
        subject to action under section 303), but such failure shall 
        not be the basis for a proceeding--
                    ``(A) to withdraw approval for a drug under section 
                505(e); or
                    ``(B) to revoke the license for a biological 
                product under section 351 of the Public Health Service 
                Act.''.
            (2) Tracking of letters issued.--Subparagraph (D) of 
        section 505B(f)(6) (21 U.S.C. 355c(f)(6)), as amended by 
        subsection (b), is further amended--
                    (A) in clause (ii), by striking ``; and'' and 
                inserting a semicolon;
                    (B) in clause (iii), by adding ``and'' at the end; 
                and
                    (C) by adding at the end the following:
                            ``(iv) the number of postmarket non-
                        compliance letters issued pursuant to 
                        subsection (d), and the recipients of such 
                        letters;''.

SEC. 8. PEDIATRIC STUDY PLANS.

    (a) In General.--Subsection (e) of section 505B (21 U.S.C. 355c) is 
amended to read as follows:
    ``(e) Pediatric Study Plans.--
            ``(1) In general.--An applicant subject to subsection (a) 
        shall submit to the Secretary an initial pediatric study plan 
        prior to the submission of the assessments described under 
        subsection (a)(2).
            ``(2) Timing; content; meeting.--
                    ``(A) Timing.--An applicant shall submit an initial 
                pediatric study plan to the Secretary not later than 60 
                calendar days after the date of the end of phase II 
                meeting or such other equivalent time agreed upon 
                between the Secretary and the applicant. Nothing in 
                this paragraph shall preclude the Secretary from 
                accepting the submission of an initial pediatric study 
                plan earlier than the date described under the 
                preceding sentence.
                    ``(B) Content of initial plan.--The initial 
                pediatric study plan shall include--
                            ``(i) an outline of the pediatric study or 
                        studies that the applicant plans to conduct 
                        (including, to the extent practicable study 
                        objectives and design, age groups, relevant 
                        endpoints, and statistical approach);
                            ``(ii) any request for a deferral, partial 
                        waiver, or waiver under this section, if 
                        applicable, along with any supporting 
                        information; and
                            ``(iii) other information specified in the 
                        regulations promulgated under paragraph (4).
                    ``(C) Meeting.--The Secretary--
                            ``(i) shall meet with the applicant to 
                        discuss the initial pediatric study plan not 
                        later than 60 calendar days after the receipt 
                        of such plan under subparagraph (A);
                            ``(ii) may determine that a written 
                        response to the initial pediatric study plan is 
                        sufficient to communicate comments on the 
                        initial pediatric study plan, and that no 
                        meeting is necessary; and
                            ``(iii) if the Secretary determines that no 
                        meeting is necessary, shall so notify the 
                        applicant and provide written comments of the 
                        Secretary not later than 60 calendar days after 
                        the receipt of the initial pediatric study 
                        plan.
            ``(3) Agreed pediatric study plan.--The applicant shall 
        document agreement on the initial pediatric study plan in a 
        submission to the Secretary marked `Agreed Pediatric Study 
        Plan', and the Secretary shall confirm such agreement to the 
        applicant in writing not later than 30 calendar days of receipt 
        of such agreed pediatric study plan.
            ``(4) Deferral and waiver.--If the agreed pediatric study 
        plan contains a request from the applicant for a deferral, 
        partial waiver, or waiver under this section, the written 
        confirmation under paragraph (3) shall include a recommendation 
        from the Secretary as to whether such request meets the 
        standards under paragraphs (3) or (4) of subsection (a).
            ``(5) Amendments to the plan.--At the initiative of the 
        Secretary or the applicant, the agreed pediatric study plan may 
        be amended at any time. The requirements of paragraph (2)(C) 
        shall apply to any such proposed amendment in the same manner 
        and to the same extent as such requirements apply to an initial 
        pediatric study plan under paragraph (1). The requirements of 
        paragraphs (3) and (4) shall apply to any agreement resulting 
        from such proposed amendment in the same manner and to the same 
        extent as such requirements apply to an agreed pediatric study 
        plan.
            ``(6) Internal committee.--The Secretary shall consult the 
        internal committee under section 505C on the review of the 
        initial pediatric plan, agreed pediatric plan, and any 
        amendments to such plans.
            ``(7) Required rulemaking.--Not later than 1 year after the 
        date of enactment of the Better Pharmaceuticals and Devices for 
        Children Act of 2012, the Secretary shall promulgate proposed 
        regulations and issue proposed guidance to implement the 
        provisions of this subsection.''.
    (b) Conforming Amendments.--Section 505B (21 U.S.C. 355c) is 
amended--
            (1) by amending subclause (II) of subsection (a)(3)(A)(ii) 
        to read as follows:
                                    ``(II) a pediatric study plan as 
                                described in subsection (e);''; and
            (2) in subsection (f)--
                    (A) in the subsection heading, by striking 
                ``Pediatric Plans,'' and inserting ``Pediatric Study 
                Plans,'';
                    (B) in paragraph (1), by striking ``all pediatric 
                plans'' and inserting ``initial pediatric study plans, 
                agreed pediatric study plans,''; and
                    (C) in paragraph (4)--
                            (i) in the paragraph heading, by striking 
                        ``Pediatric Plans,'' and inserting ``Pediatric 
                        Study Plans,''; and
                            (ii) by striking ``pediatric plans'' and 
                        inserting ``initial pediatric study plans, 
                        agreed pediatric study plans,''.
    (c) Effective Dates.--
            (1) Pediatric study plans.--Subsection (e) of section 505B 
        of the Federal Food, Drug, and Cosmetic Act (other than 
        paragraph (4) of such subsection), as amended by subsection 
        (a), shall take effect 180 days after the date of enactment of 
        this Act, without regard to whether the Secretary has 
        promulgated final regulations under paragraph (4) of such 
        subsection by such date.
            (2) Conforming amendments.--The amendments made by 
        subsection (b) shall take effect 180 days after the date of 
        enactment of this Act.

SEC. 9. REAUTHORIZATIONS.

    (a) Pediatric Advisory Committee.--Section 14(d) of the Best 
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by 
striking ``Notwithstanding section 14 of the Federal Advisory Committee 
Act, the advisory committee shall continue to operate during the five-
year period beginning on the date of the enactment of the Best 
Pharmaceuticals for Children Act of 2007'' and inserting ``Section 14 
of the Federal Advisory Committee Act shall not apply to the advisory 
committee''.
    (b) Pediatric Subcommittee of the Oncologic Drugs Advisory 
Committee.--Section 15(a)(3) of the Best Pharmaceuticals for Children 
Act (42 U.S.C. 284m note) is amended by striking `` during the five-
year period beginning on the date of the enactment of the Best 
Pharmaceuticals for Children Act of 2007'' and inserting ``for the 
duration of the operation of the Oncologic Drugs Advisory Committee''.
    (c) Humanitarian Device Exemption Extension.--Section 
520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(m)(6)(A)(iv)) is amended by striking ``2012'' and inserting 
``2017''.
    (d) Demonstration Grants To Improve Pediatric Device 
Availability.--Section 305(e) of Pediatric Medical Device Safety and 
Improvement Act (Public Law 110-85; 42 U.S.C. 282 note) is amended by 
striking ``$6,000,000 for each of fiscal years 2008 through 2012'' and 
inserting ``$4,500,000 for each of fiscal years 2013 through 2017''.
    (e) Program for Pediatric Study of Drugs in PHSA.--Section 
409I(e)(1)(B) of the Public Health Service Act (42 U.S.C. 
284m(e)(1)(B)) is amended by striking ``of the four succeeding fiscal 
years'' and inserting ``succeeding fiscal year''.

SEC. 10. REPORT.

    (a) In General.--Not later than January 1, 2016, and at the end of 
each subsequent 5-year period, the Comptroller General of the United 
States, in consultation with the Secretary of Health and Human 
Services, shall submit to Congress a report that evaluates the 
effectiveness of sections 505A and 505B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the Public 
Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by 
children are tested in pediatric populations and properly labeled for 
use in children.
    (b) Contents.--The report under subsection (a) shall include--
            (1) the number and importance of drugs and biological 
        products for children that are being tested (as of the date of 
        such report) under 505A and 505B of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the 
        Public Health Service Act (42 U.S.C. 284m), including--
                    (A) the number of labeling changes made to drugs 
                and biological products pursuant to such sections since 
                the date of enactment of this Act; and
                    (B) the importance of such drugs and biological 
                products in the improvement of the health of children;
            (2) the number of requirements under such sections 505A and 
        505B that have not met by the initial deadline provided under 
        such sections, including--
                    (A) the number of deferrals and deferral extensions 
                granted and the reasons such extensions were granted;
                    (B) the number of waivers and partial waivers 
                granted; and
                    (C) the number of letters issued under subsection 
                (d) of such section 505B;
            (3) the number of written requests issued and declined 
        under such section 505A since the date of enactment of this Act 
        (including the reasons for such declination), and a description 
        and status of referrals made under subsection (n) of such 
        section 505A;
            (4) the number and importance of drugs and biological 
        products for children that are not being tested for use in 
        pediatric populations, notwithstanding the existence of the 
        programs under such sections 505A and 505B and section 409I of 
        the Public Health Service Act;
            (5) the possible reasons for the lack of testing reported 
        under paragraph (4);
            (6) the number of drugs and biological products for which 
        testing is being done (as of the date of the report) and for 
        which a labeling change is required under the programs 
        described in paragraph (4), including--
                    (A) the date labeling changes are made;
                    (B) which labeling changes required the use of the 
                dispute resolution process; and
                    (C) for labeling changes that required such dispute 
                resolution process, a description of--
                            (i) the disputes;
                            (ii) the recommendations of the Pediatric 
                        Advisory Committee; and
                            (iii) the outcomes of such process; and
                    (D) an assessment of the effectiveness in improving 
                information about pediatric uses of drugs and 
                biological products;
            (7)(A) the efforts made by the Secretary to increase the 
        number of studies conducted in the neonatal population 
        (including efforts made to encourage the conduct of appropriate 
        studies in neonates by companies with products that have 
        sufficient safety and other information to make the conduct of 
        the studies ethical and safe); and
            (B) the results of such efforts;
            (8)(A) the number and importance of drugs and biological 
        products for children with cancer that are being tested as a 
        result of the programs described in paragraph (4); and
            (B) any recommendations for modifications to such programs 
        that would lead to new and better therapies for children with 
        cancer, including a detailed rationale for each recommendation;
            (9) an assessment of progress made in addressing the 
        recommendations and findings of any prior report issued by the 
        Comptroller General regarding the topics addressed in the 
        report under this section, including with respect to--
                    (A) improving public access to information from 
                pediatric studies conducted under such sections 505A 
                and 505B; and
                    (B) improving the timeliness of pediatric studies 
                and pediatric study planning under such sections 505A 
                and 505B;
            (10) any recommendations for modification to the programs 
        that would improve pediatric drug research and increase 
        pediatric labeling of drugs and biological products; and
            (11) an assessment of the successes of and limitations to 
        studying drugs for rare diseases under such sections 505A and 
        505B.

SEC. 11. TECHNICAL AMENDMENTS.

    (a) Pediatric Studies of Drugs in FFDCA.--Section 505A (21 U.S.C. 
355a) is amended--
            (1) in subsection (k)(2), by striking ``subsection 
        (f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
            (2) in subsection (n)--
                    (A) in the subsection heading, by striking 
                ``Completed'' and inserting ``Submitted''; and
                    (B) in paragraph (1)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``have not been completed'' 
                        and inserting ``have not been submitted by the 
                        date specified in the written request issued'';
                            (ii) in subparagraph (A)--
                                    (I) in the first sentence, by 
                                inserting ``, or for which a period of 
                                exclusivity eligible for extension 
                                under subsection (b)(1) or (c)(1) of 
                                this section or under subsection (m)(2) 
                                or (m)(3) of section 351 of the Public 
                                Health Service Act has not ended'' 
                                after ``expired''; and
                                    (II) by striking ``Prior to'' and 
                                all that follows through the period at 
                                the end; and
                            (iii) in subparagraph (B), by striking ``no 
                        listed patents or has 1 or more listed patents 
                        that have expired,'' and inserting ``no 
                        unexpired listed patents and for which no 
                        unexpired periods of exclusivity eligible for 
                        extension under subsection (b)(1) or (c)(1) of 
                        this section or under subsection (m)(2) or 
                        (m)(3) of section 351 of the Public Health 
                        Service Act apply''; and
            (3) in subsection (o)(2), by amendment subparagraph (B) to 
        read as follows:
                    ``(B) a statement of any appropriate pediatric 
                contraindications, warnings, precautions, or other 
                information that the Secretary considers necessary to 
                assure safe use.''.
    (b) Research Into Pediatric Uses for Drugs and Biological Projects 
in FFDCA.--Section 505B (21 U.S.C. 355c) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                            (i) in the matter preceding subparagraph 
                        (A), by inserting ``for a drug'' after ``(or 
                        supplement to an application)'';
                            (ii) in subparagraph (A), by striking ``for 
                        a'' and inserting ``, including, with respect 
                        to a drug, an application (or supplement to an 
                        application) for a'';
                            (iii) in subparagraph (B), by striking 
                        ``for a'' and inserting ``, including, with 
                        respect to a drug, an application (or 
                        supplement to an application) for a''; and
                            (iv) in the matter following subparagraph 
                        (B), by inserting ``(or supplement)'' after 
                        ``application''; and
                    (B) in paragraph (4)(C)--
                            (i) in the first sentence, by inserting 
                        ``partial'' before ``waiver is granted''; and
                            (ii) in the second sentence, by inserting 
                        ``such a'' after ``full or'';
            (2) in subsection (b)(1), in the matter preceding 
        subparagraph (A), by striking ``After providing notice'' and 
        all that follows through ``studies), the'' and inserting 
        ``The'';
            (3) in subsection (g)--
                    (A) in paragraph (1)(A), by inserting ``that 
                receives a priority review or 330 days after the date 
                of the submission of an application or supplement that 
                receives a standard review'' after ``after the date of 
                the submission of the application or supplement''; and
                    (B) in paragraph (2), by striking ``the label of 
                such product'' and inserting ``the labeling of such 
                product''; and
            (4) in subsection (h)(1)--
                    (A) by inserting ``an application (or supplement to 
                an application) that contains'' after ``date of 
                submission of''; and
                    (B) by inserting ``, if the application (or 
                supplement) receives a priority review, or not later 
                than 330 days after the date of submission of an 
                application (or supplement to an application) that 
                contains a pediatric assessment under this section, if 
                the application (or supplement) receives a standard 
                review,'' after ``under this section,''.
    (c) Internal Review Committee.--The heading of section 505C (21 
U.S.C. 355d) is amended by inserting ``and deferral extensions'' after 
``deferrals''.
    (d) Program for Pediatric Studies of Drugs.--Section 409I(c) of the 
Public Health Service Act (42 U.S.C. 284m(c)) is amended--
            (1) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A), by 
                inserting ``or section 351(m) of this Act,'' after 
                ``Cosmetic Act,'';
                    (B) in subparagraph (A)(i), by inserting ``or 
                section 351(k) of this Act'' after ``Cosmetic Act''; 
                and
                    (C) by amending subparagraph (B) to read as 
                follows:
                    ``(B) there remains no patent listed pursuant to 
                section 505(b)(1) of the Federal Food, Drug, and 
                Cosmetic Act, and every three-year and five-year period 
                referred to in subsection (c)(3)(E)(ii), 
                (c)(3)(E)(iii), (c)(3)(E)(iv), (j)(5)(F)(ii), 
                (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the 
                Federal Food, Drug, and Cosmetic Act, or applicable 
                twelve-year period referred to in section 351(k)(7) of 
                this Act, and any seven-year period referred to in 
                section 527 of the Federal Food, Drug, and Cosmetic Act 
                has ended for at least one form of the drug; and''; and
            (2) in paragraph (2)--
                    (A) in the paragraph heading, by striking ``for 
                drugs lacking exclusivity'';
                    (B) by striking ``under section 505 of the Federal 
                Food, Drug, and Cosmetic Act''; and
                    (C) by inserting ``or section 351(m) of this 
                Act,''.
    (e) Pediatric Subcommittee of the Oncologic Advisory Committee.--
Section 15(a) of the Best Pharmaceuticals for Children Act (Public Law 
107-109), as amended by section 502(e) of the Food and Drug 
Administration Amendments Act of 2007 (Public Law 110-85), is amended 
in paragraph (1)(D), by striking ``section 505B(f)'' and inserting 
```section 505C'''.
    (f) Foundation of National Institutes of Health.--Section 
499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) 
is amended by striking ``for which the Secretary issues a certification 
in the affirmative under section 505A(n)(1)(A) of the Federal Food, 
Drug, and Cosmetic Act''.
    (g) Application.--Notwithstanding any provision of sections 505A 
and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 
355c) stating that a provision applies beginning on the date of the 
enactment of the Best Pharmaceuticals for Children Act of 2007 or the 
date of the enactment of the Pediatric Research Equity Act of 2007, any 
amendment made by this Act to such a provision applies beginning on the 
date of the enactment of this Act.
                                 <all>