H. R. 3580—42 
(c) USE OF FUNDS.—A nonprofit consortium that receives a 
grant or contract under this section shall facilitate the development, 
production, and distribution of pediatric medical devices by— 
(1) encouraging innovation and connecting qualified 
individuals with pediatric device ideas with potential manufac-
turers; 
(2) mentoring and managing pediatric device projects 
through the development process, including product identifica-
tion, prototype design, device development, and marketing; 
(3) connecting innovators and physicians to existing Federal 
and non-Federal resources, including resources from the Food 
and Drug Administration, the National Institutes of Health, 
the Small Business Administration, the Department of Energy, 
the Department of Education, the National Science Foundation, 
the Department of Veterans Affairs, the Agency for Healthcare 
Research and Quality, and the National Institute of Standards 
and Technology; 
(4) assessing the scientific and medical merit of proposed 
pediatric device projects; and 
(5) providing assistance and advice as needed on business 
development, 
personnel 
training, 
prototype 
development, 
postmarket needs, and other activities consistent with the pur-
poses of this section. 
(d) COORDINATION.— 
(1) NATIONAL
INSTITUTES
OF
HEALTH.—Each consortium 
that receives a grant or contract under this section shall— 
(A) coordinate with the National Institutes of Health’s 
pediatric device contact point or office, designated under 
section 402(b)(23) of the Public Health Service Act, as 
added by section 304(a) of this Act; and 
(B) provide to the National Institutes of Health any 
identified pediatric device needs that the consortium lacks 
sufficient capacity to address or those needs in which the 
consortium has been unable to stimulate manufacturer 
interest. 
(2) FOOD
AND
DRUG
ADMINISTRATION.—Each consortium 
that receives a grant or contract under this section shall coordi-
nate with the Commissioner of Food and Drugs and device 
companies to facilitate the application for approval or clearance 
of devices labeled for pediatric use. 
(3) EFFECTIVENESS AND OUTCOMES.—Each consortium that 
receives a grant or contract under this section shall annually 
report to the Secretary of Health and Human Services on 
the status of pediatric device development, production, and 
distribution that has been facilitated by the consortium. 
(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 
to be appropriated to carry out this section $6,000,000 for each 
of fiscal years 2008 through 2012. 
SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS 
AND PEDIATRIC ADVISORY COMMITTEE. 
(a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 6(b) of the 
Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is 
amended by inserting ‘‘, including increasing pediatric access to 
medical devices’’ after ‘‘pediatric issues’’.
H. R. 3580—43 
(b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 of the Best 
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is 
amended— 
(1) in subsection (a), by inserting ‘‘(including drugs and 
biological products) and medical devices’’ after ‘‘therapeutics’’; 
and 
(2) in subsection (b)— 
(A) in paragraph (1), by inserting ‘‘(including drugs 
and biological products) and medical devices’’ after ‘‘thera-
peutics’’; and 
(B) in paragraph (2)— 
(i) in subparagraph (A), by striking ‘‘and 505B’’ 
and inserting ‘‘505B, 510(k), 515, and 520(m)’’; 
(ii) by striking subparagraph (B) and inserting 
the following: 
‘‘(B) identification of research priorities related to 
therapeutics (including drugs and biological products) and 
medical devices for pediatric populations and the need for 
additional diagnostics and treatments for specific pediatric 
diseases or conditions;’’; and 
(iii) in subparagraph (C), by inserting ‘‘(including 
drugs and biological products) and medical devices’’ 
after ‘‘therapeutics’’. 
SEC. 307. POSTMARKET SURVEILLANCE. 
Section 522 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360l) is amended— 
(1) by amending the section heading and designation to 
read as follows: 
‘‘SEC. 522. POSTMARKET SURVEILLANCE.’’; 
(2) by striking subsection (a) and inserting the following: 
‘‘(a) POSTMARKET SURVEILLANCE.— 
‘‘(1) IN GENERAL.— 
‘‘(A) CONDUCT.—The Secretary may by order require 
a manufacturer to conduct postmarket surveillance for any 
device of the manufacturer that is a class II or class III 
device— 
‘‘(i) the failure of which would be reasonably likely 
to have serious adverse health consequences; 
‘‘(ii) that is expected to have significant use in 
pediatric populations; or 
‘‘(iii) that is intended to be— 
‘‘(I) implanted in the human body for more 
than 1 year; or 
‘‘(II) a life-sustaining or life-supporting device 
used outside a device user facility. 
‘‘(B) 
CONDITION.—The 
Secretary 
may 
order 
a 
postmarket surveillance under subparagraph (A) as a condi-
tion to approval or clearance of a device described in 
subparagraph (A)(ii). 
‘‘(2) RULE OF CONSTRUCTION.—The provisions of paragraph 
(1) shall have no effect on authorities otherwise provided under 
the Act or regulations issued under this Act.’’; and 
(3) in subsection (b)— 
(A) by striking ‘‘(b) SURVEILLANCE APPROVAL.—Each’’ 
and inserting the following: 
‘‘(b) SURVEILLANCE APPROVAL.—
H. R. 3580—44 
‘‘(1) IN GENERAL.—Each’’; 
(B) by striking ‘‘The Secretary, in consultation’’ and 
inserting ‘‘Except as provided in paragraph (2), the Sec-
retary, in consultation’’; 
(C) by striking ‘‘Any determination’’ and inserting 
‘‘Except as provided in paragraph (2), any determination’’; 
and 
(D) by adding at the end the following: 
‘‘(2) LONGER SURVEILLANCE FOR PEDIATRIC DEVICES.—The 
Secretary may by order require a prospective surveillance 
period of more than 36 months with respect to a device that 
is expected to have significant use in pediatric populations 
if such period of more than 36 months is necessary in order 
to assess the impact of the device on growth and development, 
or the effects of growth, development, activity level, or other 
factors on the safety or efficacy of the device. 
‘‘(c) DISPUTE RESOLUTION.—A manufacturer may request review 
under section 562 of any order or condition requiring postmarket 
surveillance under this section. During the pendency of such review, 
the device subject to such a postmarket surveillance order or condi-
tion shall not, because of noncompliance with such order or condi-
tion, be deemed in violation of section 301(q)(1)(C), adulterated 
under section 501(f)(1), misbranded under section 502(t)(3), or in 
violation of, as applicable, section 510(k) or section 515, unless 
deemed necessary to protect the public health.’’. 
TITLE IV—PEDIATRIC RESEARCH 
EQUITY ACT OF 2007 
SEC. 401. SHORT TITLE. 
This title may be cited as the ‘‘Pediatric Research Equity Act 
of 2007’’. 
SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT. 
(a) IN GENERAL.—Section 505B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355c) is amended to read as follows: 
‘‘SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND 
BIOLOGICAL PRODUCTS. 
‘‘(a) NEW DRUGS AND BIOLOGICAL PRODUCTS.— 
‘‘(1) IN GENERAL.—A person that submits, on or after the 
date of the enactment of the Pediatric Research Equity Act 
of 2007, an application (or supplement to an application)— 
‘‘(A) under section 505 for a new active ingredient, 
new indication, new dosage form, new dosing regimen, 
or new route of administration, or 
‘‘(B) under section 351 of the Public Health Service 
Act (42 U.S.C. 262) for a new active ingredient, new indica-
tion, new dosage form, new dosing regimen, or new route 
of administration, 
shall submit with the application the assessments described 
in paragraph (2). 
‘‘(2) ASSESSMENTS.— 
‘‘(A) IN GENERAL.—The assessments referred to in para-
graph (1) shall contain data, gathered using appropriate
H. R. 3580—45 
formulations for each age group for which the assessment 
is required, that are adequate— 
‘‘(i) to assess the safety and effectiveness of the 
drug or the biological product for the claimed indica-
tions in all relevant pediatric subpopulations; and 
‘‘(ii) to support dosing and administration for each 
pediatric subpopulation for which the drug or the 
biological product is safe and effective. 
‘‘(B) SIMILAR COURSE OF DISEASE OR SIMILAR EFFECT 
OF DRUG OR BIOLOGICAL PRODUCT.— 
‘‘(i) IN GENERAL.—If the course of the disease and 
the effects of the drug are sufficiently similar in adults 
and pediatric patients, the Secretary may conclude 
that pediatric effectiveness can be extrapolated from 
adequate and well-controlled studies in adults, usually 
supplemented with other information obtained in pedi-
atric patients, such as pharmacokinetic studies. 
‘‘(ii) EXTRAPOLATION
BETWEEN
AGE
GROUPS.—A 
study may not be needed in each pediatric age group 
if data from one age group can be extrapolated to 
another age group. 
‘‘(iii) INFORMATION
ON
EXTRAPOLATION.—A brief 
documentation of the scientific data supporting the 
conclusion under clauses (i) and (ii) shall be included 
in any pertinent reviews for the application under sec-
tion 505 of this Act or section 351 of the Public Health 
Service Act (42 U.S.C. 262). 
‘‘(3) DEFERRAL.— 
‘‘(A) IN GENERAL.—On the initiative of the Secretary 
or at the request of the applicant, the Secretary may defer 
submission of some or all assessments required under para-
graph (1) until a specified date after approval of the drug 
or issuance of the license for a biological product if— 
‘‘(i) the Secretary finds that— 
‘‘(I) the drug or biological product is ready 
for approval for use in adults before pediatric 
studies are complete; 
‘‘(II) pediatric studies should be delayed until 
additional safety or effectiveness data have been 
collected; or 
‘‘(III) there is another appropriate reason for 
deferral; and 
‘‘(ii) the applicant submits to the Secretary— 
‘‘(I) certification of the grounds for deferring 
the assessments; 
‘‘(II) a description of the planned or ongoing 
studies; 
‘‘(III) evidence that the studies are being con-
ducted or will be conducted with due diligence 
and at the earliest possible time; and 
‘‘(IV) a timeline for the completion of such 
studies. 
‘‘(B) ANNUAL REVIEW.— 
‘‘(i) IN GENERAL.—On an annual basis following 
the approval of a deferral under subparagraph (A), 
the applicant shall submit to the Secretary the fol-
lowing information:
H. R. 3580—46 
‘‘(I) Information detailing the progress made 
in conducting pediatric studies. 
‘‘(II) If no progress has been made in con-
ducting such studies, evidence and documentation 
that such studies will be conducted with due dili-
gence and at the earliest possible time. 
‘‘(ii) PUBLIC AVAILABILITY.—The information sub-
mitted through the annual review under clause (i) 
shall promptly be made available to the public in an 
easily accessible manner, including through the Web 
site of the Food and Drug Administration. 
‘‘(4) WAIVERS.— 
‘‘(A) FULL WAIVER.—On the initiative of the Secretary 
or at the request of an applicant, the Secretary shall grant 
a full waiver, as appropriate, of the requirement to submit 
assessments for a drug or biological product under this 
subsection if the applicant certifies and the Secretary finds 
that— 
‘‘(i) necessary studies are impossible or highly 
impracticable (because, for example, the number of 
patients is so small or the patients are geographically 
dispersed); 
‘‘(ii) there is evidence strongly suggesting that the 
drug or biological product would be ineffective or 
unsafe in all pediatric age groups; or 
‘‘(iii) the drug or biological product— 
‘‘(I) does not represent a meaningful thera-
peutic benefit over existing therapies for pediatric 
patients; and 
‘‘(II) is not likely to be used in a substantial 
number of pediatric patients. 
‘‘(B) PARTIAL WAIVER.—On the initiative of the Sec-
retary or at the request of an applicant, the Secretary 
shall grant a partial waiver, as appropriate, of the require-
ment to submit assessments for a drug or biological product 
under this subsection with respect to a specific pediatric 
age group if the applicant certifies and the Secretary finds 
that— 
‘‘(i) necessary studies are impossible or highly 
impracticable (because, for example, the number of 
patients in that age group is so small or patients 
in that age group are geographically dispersed); 
‘‘(ii) there is evidence strongly suggesting that the 
drug or biological product would be ineffective or 
unsafe in that age group; 
‘‘(iii) the drug or biological product— 
‘‘(I) does not represent a meaningful thera-
peutic benefit over existing therapies for pediatric 
patients in that age group; and 
‘‘(II) is not likely to be used by a substantial 
number of pediatric patients in that age group; 
or 
‘‘(iv) the applicant can demonstrate that reasonable 
attempts to produce a pediatric formulation necessary 
for that age group have failed. 
‘‘(C) PEDIATRIC
FORMULATION
NOT
POSSIBLE.—If a 
waiver is granted on the ground that it is not possible
H. R. 3580—47 
to develop a pediatric formulation, the waiver shall cover 
only the pediatric groups requiring that formulation. An 
applicant seeking either a full or partial waiver shall 
submit to the Secretary documentation detailing why a 
pediatric formulation cannot be developed and, if the waiver 
is granted, the applicant’s submission shall promptly be 
made available to the public in an easily accessible manner, 
including through posting on the Web site of the Food 
and Drug Administration. 
‘‘(D) LABELING REQUIREMENT.—If the Secretary grants 
a full or partial waiver because there is evidence that 
a drug or biological product would be ineffective or unsafe 
in pediatric populations, the information shall be included 
in the labeling for the drug or biological product. 
‘‘(b) MARKETED DRUGS AND BIOLOGICAL PRODUCTS.— 
‘‘(1) IN GENERAL.—After providing notice in the form of 
a letter (that, for a drug approved under section 505, references 
a declined written request under section 505A for a labeled 
indication which written request is not referred under section 
505A(n)(1)(A) to the Foundation of the National Institutes of 
Health for the pediatric studies), the Secretary may (by order 
in the form of a letter) require the sponsor or holder of an 
approved application for a drug under section 505 or the holder 
of a license for a biological product under section 351 of the 
Public Health Service Act to submit by a specified date the 
assessments described in subsection (a)(2), if the Secretary 
finds that— 
‘‘(A)(i) the drug or biological product is used for a 
substantial number of pediatric patients for the labeled 
indications; and 
‘‘(ii) adequate pediatric labeling could confer a benefit 
on pediatric patients; 
‘‘(B) there is reason to believe that the drug or 
biological product would represent a meaningful thera-
peutic benefit over existing therapies for pediatric patients 
for 1 or more of the claimed indications; or 
‘‘(C) the absence of adequate pediatric labeling could 
pose a risk to pediatric patients. 
‘‘(2) WAIVERS.— 
‘‘(A) FULL WAIVER.—At the request of an applicant, 
the Secretary shall grant a full waiver, as appropriate, 
of the requirement to submit assessments under this sub-
section if the applicant certifies and the Secretary finds 
that— 
‘‘(i) necessary studies are impossible or highly 
impracticable (because, for example, the number of 
patients in that age group is so small or patients 
in that age group are geographically dispersed); or 
‘‘(ii) there is evidence strongly suggesting that the 
drug or biological product would be ineffective or 
unsafe in all pediatric age groups. 
‘‘(B) PARTIAL WAIVER.—At the request of an applicant, 
the Secretary shall grant a partial waiver, as appropriate, 
of the requirement to submit assessments under this sub-
section with respect to a specific pediatric age group if 
the applicant certifies and the Secretary finds that—
H. R. 3580—48 
‘‘(i) necessary studies are impossible or highly 
impracticable (because, for example, the number of 
patients in that age group is so small or patients 
in that age group are geographically dispersed); 
‘‘(ii) there is evidence strongly suggesting that the 
drug or biological product would be ineffective or 
unsafe in that age group; 
‘‘(iii)(I) the drug or biological product— 
‘‘(aa) does not represent a meaningful thera-
peutic benefit over existing therapies for pediatric 
patients in that age group; and 
‘‘(bb) is not likely to be used in a substantial 
number of pediatric patients in that age group; 
and 
‘‘(II) the absence of adequate labeling could not 
pose significant risks to pediatric patients; or 
‘‘(iv) the applicant can demonstrate that reasonable 
attempts to produce a pediatric formulation necessary 
for that age group have failed. 
‘‘(C) PEDIATRIC
FORMULATION
NOT
POSSIBLE.—If a 
waiver is granted on the ground that it is not possible 
to develop a pediatric formulation, the waiver shall cover 
only the pediatric groups requiring that formulation. An 
applicant seeking either a full or partial waiver shall 
submit to the Secretary documentation detailing why a 
pediatric formulation cannot be developed and, if the waiver 
is granted, the applicant’s submission shall promptly be 
made available to the public in an easily accessible manner, 
including through posting on the Web site of the Food 
and Drug Administration. 
‘‘(D) LABELING REQUIREMENT.—If the Secretary grants 
a full or partial waiver because there is evidence that 
a drug or biological product would be ineffective or unsafe 
in pediatric populations, the information shall be included 
in the labeling for the drug or biological product. 
‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection 
alters or amends section 301(j) of this Act or section 552 of 
title 5 or section 1905 of title 18, United States Code. 
‘‘(c) MEANINGFUL THERAPEUTIC BENEFIT.—For the purposes of 
paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) and para-
graphs (1)(B) and (2)(B)(iii)(I)(aa) of subsection (b), a drug or 
biological product shall be considered to represent a meaningful 
therapeutic benefit over existing therapies if the Secretary deter-
mines that— 
‘‘(1) if approved, the drug or biological product could rep-
resent an improvement in the treatment, diagnosis, or preven-
tion of a disease, compared with marketed products adequately 
labeled for that use in the relevant pediatric population; or 
‘‘(2) the drug or biological product is in a class of products 
or for an indication for which there is a need for additional 
options. 
‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person fails to submit 
an assessment described in subsection (a)(2), or a request for 
approval of a pediatric formulation described in subsection (a) or 
(b), in accordance with applicable provisions of subsections (a) and 
(b)—
H. R. 3580—49 
‘‘(1) the drug or biological product that is the subject of 
the assessment or request 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 
‘‘(2) the failure to submit the assessment or request 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. 
‘‘(e) MEETINGS.—Before and during the investigational process 
for a new drug or biological product, the Secretary shall meet 
at appropriate times with the sponsor of the new drug or biological 
product to discuss— 
‘‘(1) information that the sponsor submits on plans and 
timelines for pediatric studies; or 
‘‘(2) any planned request by the sponsor for waiver or 
deferral of pediatric studies. 
‘‘(f) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, 
AND WAIVERS.— 
‘‘(1) REVIEW.—Beginning not later than 30 days after the 
date of the enactment of the Pediatric Research Equity Act 
of 2007, the Secretary shall utilize the internal committee estab-
lished under section 505C to provide consultation to reviewing 
divisions on all pediatric plans and assessments prior to 
approval of an application or supplement for which a pediatric 
assessment is required under this section and all deferral and 
waiver requests granted pursuant to this section. 
‘‘(2) ACTIVITY BY COMMITTEE.—The committee referred to 
in paragraph (1) may operate using appropriate members of 
such committee and need not convene all members of the com-
mittee. 
‘‘(3) DOCUMENTATION
OF
COMMITTEE
ACTION.—For each 
drug or biological product, the committee referred to in para-
graph (1) shall document, for each activity described in para-
graph (4) or (5), which members of the committee participated 
in such activity. 
‘‘(4) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, 
AND
WAIVERS.—Consultation on pediatric plans and assess-
ments by the committee referred to in paragraph (1) pursuant 
to this section shall occur prior to approval of an application 
or supplement for which a pediatric assessment is required 
under this section. The committee shall review all requests 
for deferrals and waivers from the requirement to submit a 
pediatric assessment granted under this section and shall pro-
vide recommendations as needed to reviewing divisions, 
including with respect to whether such a supplement, when 
submitted, shall be considered for priority review. 
‘‘(5) RETROSPECTIVE
REVIEW
OF
PEDIATRIC
ASSESSMENTS, 
DEFERRALS, AND WAIVERS.—Not later than 1 year after the 
date of the enactment of the Pediatric Research Equity Act 
of 2007, the committee referred to in paragraph (1) shall con-
duct a retrospective review and analysis of a representative 
sample of assessments submitted and deferrals and waivers 
approved under this section since the enactment of the Pediatric 
Research Equity Act of 2003. Such review shall include an
H. R. 3580—50 
analysis of the quality and consistency of pediatric information 
in pediatric assessments and the appropriateness of waivers 
and deferrals granted. Based on such review, the Secretary 
shall issue recommendations to the review divisions for 
improvements and initiate guidance to industry related to the 
scope of pediatric studies required under this section. 
‘‘(6) TRACKING OF ASSESSMENTS AND LABELING CHANGES.— 
The Secretary, in consultation with the committee referred 
to in paragraph (1), shall track and make available to the 
public in an easily accessible manner, including through posting 
on the Web site of the Food and Drug Administration— 
‘‘(A) the number of assessments conducted under this 
section; 
‘‘(B) the specific drugs and biological products and their 
uses assessed under this section; 
‘‘(C) the types of assessments conducted under this 
section, including trial design, the number of pediatric 
patients studied, and the number of centers and countries 
involved; 
‘‘(D) the total number of deferrals requested and 
granted under this section and, if granted, the reasons 
for such deferrals, the timeline for completion, and the 
number completed and pending by the specified date, as 
outlined in subsection (a)(3); 
‘‘(E) the number of waivers requested and granted 
under this section and, if granted, the reasons for the 
waivers; 
‘‘(F) the number of pediatric formulations developed 
and the number of pediatric formulations not developed 
and the reasons any such formulation was not developed; 
‘‘(G) the labeling changes made as a result of assess-
ments conducted under this section; 
‘‘(H) an annual summary of labeling changes made 
as a result of assessments conducted under this section 
for distribution pursuant to subsection (h)(2); 
‘‘(I) an annual summary of information submitted 
pursuant to subsection (a)(3)(B); and 
‘‘(J) the number of times the committee referred to 
in paragraph (1) made a recommendation to the Secretary 
under paragraph (4) regarding priority review, the number 
of times the Secretary followed or did not follow such 
a recommendation, and, if not followed, the reasons why 
such a recommendation was not followed. 
‘‘(g) LABELING CHANGES.— 
‘‘(1) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST FOR LABELING CHANGE AND FAILURE TO 
AGREE.—If, on or after the date of the enactment of the 
Pediatric Research Equity Act of 2007, the Commissioner 
determines that a sponsor and the Commissioner have 
been unable to reach agreement on appropriate changes 
to the labeling for the drug that is the subject of the 
application or supplement, not later than 180 days after 
the date of the submission of the application or supple-
ment— 
‘‘(i) the Commissioner shall request that the 
sponsor of the application make any labeling change