‘‘(I) compliance data for the establishment in 
accordance with clause (iii)(I); or 
‘‘(II) information concerning the relationship 
between the owner or operator of the establishment 
and the accredited person identified in such notice in 
accordance with clause (iii)(II). 
The owner or operator of the establishment, or such ac-
credited person, as the case may be, shall respond to such 
a request not later than 60 days after receiving such re-
quest. 
‘‘(iii)(I) The compliance data to be submitted by the 
owner or operation of a device establishment in response 
to a request under clause (ii)(I) are data describing wheth-
er the quality controls of the establishment have been suf-
ficient for ensuring consistent compliance with current 
good manufacturing practice within the meaning of section 
501(h) and with other applicable provisions of this Act. 
Such data shall include complete reports of inspectional 
findings regarding good manufacturing practice or other 
quality control audits that, during the preceding 2-year 
period, were conducted at the establishment by persons 
other than the owner or operator of the establishment, to-
gether with all other compliance data the Secretary deems 
necessary. Data under the preceding sentence shall dem-
onstrate to the Secretary whether the establishment has
facilitated consistent compliance by promptly correcting 
any compliance problems identified in such inspections. 
‘‘(II) A request to an accredited person under clause 
(ii)(II) may not seek any information that is not required 
to be maintained by such person in records under sub-
section (f)(1). 
‘‘(iv) A device establishment is deemed to have clear-
ance to participate in the program and to use the accred-
ited person identified in the notice under subparagraph 
(A)(ii) for inspections of the establishment unless the Sec-
retary, not later than 60 days after receiving the informa-
tion requested under clause (ii), issues a response that de-
nies clearance to participate as provided under subpara-
graph (C). 
‘‘(C)(i) The Secretary may deny clearance to a device 
establishment if the Secretary has evidence that the cer-
tification under subparagraph (A)(ii)(IV) is untrue and 
the Secretary provides to the owner or operator of the es-
tablishment a statement summarizing such evidence. 
‘‘(ii) The Secretary may deny clearance to a device 
establishment if the Secretary determines that the estab-
lishment has failed to demonstrate consistent compliance 
for purposes of subparagraph (B)(iii)(I) and the Secretary 
provides to the owner or operator of the establishment a 
statement of the reasons for such determination.
‘‘(iii)(I) The Secretary may reject the selection of the 
accredited person identified in the notice under subpara-
graph (A)(ii) if the Secretary provides to the owner or op-
erator of the establishment a statement of the reasons for 
such rejection. Reasons for the rejection may include that 
the establishment or the accredited person, as the case 
may be, has failed to fully respond to the request, or that 
the Secretary has concerns regarding the relationship be-
tween the establishment and such accredited person. 
‘‘(II) If the Secretary rejects the selection of an ac-
credited person by the owner or operator of a device estab-
lishment, the owner or operator may make an additional 
selection of an accredited person by submitting to the Sec-
retary a notice that identifies the additional selection. 
Clauses (i) and (ii) of subparagraph (B), and subclause 
(I) of this clause, apply to the selection of an accredited 
person through a notice under the preceding sentence in 
the same manner and to the same extent as such provi-
sions apply to a selection of an accredited person through 
a notice under subparagraph (A)(ii). 
‘‘(iv) In the case of a device establishment that is de-
nied clearance under clause (i) or (ii) or with respect to 
which the selection of the accredited person is rejected 
under clause (iii), the Secretary shall designate a person 
to review the statement of reasons, or statement summa-
rizing such evidence, as the case may be, of the Secretary 
under such clause if, during the 30-day period beginning 
on the date on which the owner or operator of the estab-
lishment receives such statement, the owner or operator 
requests the review. The review shall commence not later 
than 30 days after the owner or operator requests the re-
view, unless the Secretary and the owner or operator oth-
erwise agree.’’; 
(5) in paragraph (7)— 
(A) in subparagraph (A), by striking ‘‘(A) 
Persons’’ and all that follows through the end 
and inserting the following: ‘‘(A) Persons ac-
credited under paragraph (2) to conduct inspec-
tions shall record in writing their inspection ob-
servations and shall present the observations to 
the device establishment’s designated represent-
ative and describe each observation. Addition-
ally, such accredited person shall prepare an in-
spection report in a form and manner des-
ignated by the Secretary to conduct inspections, 
taking into consideration the goals of inter-
national harmonization of quality systems 
standards. Any official classification of the in-
spection shall be determined by the Secretary.’’; 
and
(B) by adding at the end the following: 
‘‘(F) For the 
purpose 
of 
setting 
risk-based 
inspectional priorities, the Secretary shall accept voluntary 
submissions of reports of audits assessing conformance 
with appropriate quality systems standards set by the 
International Organization for Standardization (ISO) and 
identified by the Secretary in public notice. If the owner 
or operator of an establishment elects to submit audit re-
ports under this subparagraph, the owner or operator shall 
submit all such audit reports with respect to the establish-
ment during the preceding 2-year periods.’’; and 
(6) in paragraph (10)(C)(iii), by striking 
‘‘based’’ and inserting ‘‘base’’. 
SEC. 229. STUDY OF NOSOCOMIAL INFECTIONS RELATING 
TO MEDICAL DEVICES. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study on— 
(1) the number of nosocomial infections attrib-
utable to new and reused medical devices; and 
(2) the causes of such nosocomial infections, in-
cluding the following: 
(A) Reprocessed single use devices. 
(B) Handling of sterilized medical devices. 
(C) In-hospital sterilization of medical de-
vices.
(D) Health care professionals’ practices for 
patient examination and treatment. 
(E) Hospital-based policies and procedures 
for infection control and prevention. 
(F) Hospital-based practices for handling 
of medical waste. 
(G) Other causes. 
(b) REPORT.—Not later than 1 year after the date 
of the enactment of this Act, the Comptroller General shall 
complete the study under subsection (a) and submit to the 
Congress a report on the results of such study. 
(c) 
DEFINITION.—In 
this 
section, 
the 
term 
‘‘nosocomial infection’’ means an infection that is acquired 
while an individual is a patient at a hospital and was nei-
ther present nor incubating in the patient prior to receiv-
ing services in the hospital. 
TITLE III—PEDIATRIC MEDICAL 
DEVICE 
SAFETY 
AND 
IM-
PROVEMENT ACT OF 2007 
SEC. 301. SHORT TITLE. 
This title may be cited as the ‘‘Pediatric Medical De-
vice Safety and Improvement Act of 2007’’.
SEC. 302. TRACKING PEDIATRIC DEVICE APPROVALS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 515 the following: 
‘‘SEC. 515A. PEDIATRIC USES OF DEVICES. 
‘‘(a) NEW DEVICES.— 
‘‘(1) IN GENERAL.—A person that submits to 
the Secretary an application under section 520(m), 
or an application (or supplement to an application) 
or a product development protocol under section 
515, shall include in the application or protocol the 
information described in paragraph (2). 
‘‘(2) REQUIRED
INFORMATION.—The applica-
tion or protocol described in paragraph (1) shall in-
clude, with respect to the device for which approval 
is sought and if readily available— 
‘‘(A) a description of any pediatric sub-
populations that suffer from the disease or con-
dition that the device is intended to treat, diag-
nose, or cure; and 
‘‘(B) the number of affected pediatric pa-
tients. 
‘‘(3) ANNUAL
REPORT.—Not later than 18 
months after the date of enactment of this section, 
and annually thereafter, the Secretary shall submit 
to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on En-
ergy and Commerce of the House of Representatives 
a report that includes— 
‘‘(A) the number of devices approved in the 
year preceding the year in which the report is 
submitted, for which there is a pediatric sub-
population that suffers from the disease or con-
dition that the device is intended to treat, diag-
nose, or cure; 
‘‘(B) the number of devices approved in 
the year preceding the year in which the report 
is submitted, labeled for use in pediatric pa-
tients; 
‘‘(C) the number of pediatric devices ap-
proved in the year preceding the year in which 
the report is submitted, exempted from a fee 
pursuant to section 738(a)(2)(B)(v); and 
‘‘(D) the review time for each device de-
scribed in subparagraphs (A), (B), and (C). 
‘‘(b) DETERMINATION
OF PEDIATRIC EFFECTIVE-
NESS BASED ON SIMILAR COURSE OF DISEASE OR CONDI-
TION OR SIMILAR EFFECT OF DEVICE ON ADULTS.— 
‘‘(1) IN GENERAL.—If the course of the disease 
or condition and the effects of the device are suffi-
ciently similar in adults and pediatric patients, the
Secretary may conclude that adult data may be used 
to support a determination of a reasonable assur-
ance of effectiveness in pediatric populations, as ap-
propriate. 
‘‘(2) EXTRAPOLATION
BETWEEN
SUBPOPULA-
TIONS.—A study may not be needed in each pedi-
atric subpopulation if data from one subpopulation 
can be extrapolated to another subpopulation. 
‘‘(c) PEDIATRIC SUBPOPULATION.—For purposes of 
this section, the term ‘pediatric subpopulation’ has the 
meaning given the term in section 520(m)(6)(E)(ii).’’. 
SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EX-
EMPTION. 
(a) IN GENERAL.—Section 520(m) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is 
amended— 
(1) in paragraph (3), by striking ‘‘No’’ and in-
serting ‘‘Except as provided in paragraph (6), no’’; 
(2) in paragraph (5)— 
(A) by inserting ‘‘, if the Secretary has 
reason to believe that the requirements of para-
graph (6) are no longer met,’’ after ‘‘public 
health’’; and 
(B) by adding at the end the following: ‘‘If 
the person granted an exemption under para-
graph (2) fails to demonstrate continued com-
pliance with the requirements of this sub-
section, the Secretary may suspend or withdraw 
the exemption from the effectiveness require-
ments of sections 514 and 515 for a humani-
tarian device only after providing notice and an 
opportunity for an informal hearing.’’; and 
(3) by striking paragraph (6) and inserting 
after paragraph (5) the following new paragraphs: 
‘‘(6)(A) Except as provided in subparagraph (D), the 
prohibition in paragraph (3) shall not apply with respect 
to a person granted an exemption under paragraph (2) 
if each of the following conditions apply: 
‘‘(i)(I) The device with respect to which the ex-
emption is granted is intended for the treatment or 
diagnosis of a disease or condition that occurs in pe-
diatric patients or in a pediatric subpopulation, and 
such device is labeled for use in pediatric patients or 
in a pediatric subpopulation in which the disease or 
condition occurs. 
‘‘(II) The device was not previously approved 
under this subsection for the pediatric patients or 
the pediatric subpopulation described in subclause 
(I) prior to the date of enactment of the Pediatric
Medical Device Safety and Improvement Act of 
2007. 
‘‘(ii) During any calendar year, the number of 
such devices distributed during that year does not 
exceed the annual distribution number specified by 
the Secretary when the Secretary grants such ex-
emption. The annual distribution number shall be 
based on the number of individuals affected by the 
disease or condition that such device is intended to 
treat, diagnose, or cure, and of that number, the 
number of individuals likely to use the device, and 
the number of devices reasonably necessary to treat 
such individuals. In no case shall the annual dis-
tribution number exceed the number identified in 
paragraph (2)(A). 
‘‘(iii) Such person immediately notifies the Sec-
retary if the number of such devices distributed dur-
ing any calendar year exceeds the annual distribu-
tion number referred to in clause (ii). 
‘‘(iv) The request for such exemption is sub-
mitted on or before October 1, 2013. 
‘‘(B) The Secretary may inspect the records relating 
to the number of devices distributed during any calendar 
year of a person granted an exemption under paragraph
(2) for which the prohibition in paragraph (3) does not 
apply. 
‘‘(C) A person may petition the Secretary to modify 
the annual distribution number specified by the Secretary 
under subparagraph (A)(ii) with respect to a device if ad-
ditional information on the number of individuals affected 
by the disease or condition arises, and the Secretary may 
modify such number but in no case shall the annual dis-
tribution number exceed the number identified in para-
graph (2)(A). 
‘‘(D) If a person notifies the Secretary, or the Sec-
retary determines through an inspection under subpara-
graph (B), that the number of devices distributed during 
any calendar year exceeds the annual distribution number, 
as required under subparagraph (A)(iii), and modified 
under subparagraph (C), if applicable, then the prohibi-
tion in paragraph (3) shall apply with respect to such per-
son for such device for any sales of such device after such 
notification. 
‘‘(E)(i) In this subsection, the term ‘pediatric pa-
tients’ means patients who are 21 years of age or younger 
at the time of the diagnosis or treatment. 
‘‘(ii) In this subsection, the term ‘pediatric sub-
population’ means 1 of the following populations: 
‘‘(I) Neonates.
‘‘(II) Infants. 
‘‘(III) Children. 
‘‘(IV) Adolescents. 
‘‘(7) The Secretary shall refer any report of an ad-
verse event regarding a device for which the prohibition 
under paragraph (3) does not apply pursuant to para-
graph (6)(A) that the Secretary receives to the Office of 
Pediatric Therapeutics, established under section 6 of the 
Best Pharmaceuticals for Children Act (Public Law 107– 
109). In considering the report, the Director of the Office 
of Pediatric Therapeutics, in consultation with experts in 
the Center for Devices and Radiological Health, shall pro-
vide for periodic review of the report by the Pediatric Ad-
visory Committee, including obtaining any recommenda-
tions of such committee regarding whether the Secretary 
should take action under this Act in response to the re-
port. 
‘‘(8) In consultation with the Office of Pediatric 
Therapeutics and the Center for Devices and Radiological 
Health, the Secretary shall provide for an annual review 
by the Pediatric Advisory Committee of all devices de-
scribed in paragraph (6) to ensure that the exemption 
under paragraph (2) remains appropriate for the pediatric 
populations for which it is granted.’’.
(b) REPORT.—Not later than January 1, 2012, the 
Comptroller General of the United States shall submit to 
the Committee on Health, Education, Labor, and Pen-
sions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives a report on 
the impact of allowing persons granted an exemption 
under section 520(m)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)(2)) with respect to a 
device to profit from such device pursuant to section 
520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amend-
ed by subsection (a)), including— 
(1) an assessment of whether such section 
520(m)(6) (as amended by subsection (a)) has in-
creased the availability of pediatric devices for condi-
tions that occur in small numbers of children, in-
cluding any increase or decrease in the number of— 
(A) exemptions granted under such section 
520(m)(2) for pediatric devices; and 
(B) applications approved under section 
515 of such Act (21 U.S.C. 360e) for devices 
intended to treat, diagnose, or cure conditions 
that occur in pediatric patients or for devices 
labeled for use in a pediatric population; 
(2) the conditions or diseases the pediatric de-
vices were intended to treat or diagnose and the esti-
mated size of the pediatric patient population for 
each condition or disease; 
(3) the costs of the pediatric devices, based on 
a survey of children’s hospitals; 
(4) the extent to which the costs of such devices 
are covered by health insurance; 
(5) the impact, if any, of allowing profit on ac-
cess to such devices for patients; 
(6) the profits made by manufacturers for each 
device that receives an exemption; 
(7) an estimate of the extent of the use of the 
pediatric devices by both adults and pediatric popu-
lations for a condition or disease other than the con-
dition or disease on the label of such devices; 
(8) recommendations of the Comptroller Gen-
eral of the United States regarding the effectiveness 
of such section 520(m)(6) (as amended by sub-
section (a)) and whether any modifications to such 
section 520(m)(6) (as amended by subsection (a)) 
should be made; 
(9) existing obstacles to pediatric device devel-
opment; and 
(10) an evaluation of the demonstration grants 
described in section 305.
(c) GUIDANCE.—Not later than 180 days after the 
date of enactment of this Act, the Commissioner of Food 
and Drugs shall issue guidance for institutional review 
committees on how to evaluate requests for approval for 
devices for which a humanitarian device exemption under 
section 520(m)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(m)(2)) has been granted. 
SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RE-
SEARCH. 
(a) ACCESS TO FUNDING.—The Director of the Na-
tional Institutes of Health shall designate a contact point 
or office at the National Institutes of Health to help 
innovators and physicians access funding for pediatric 
medical device development. 
(b) PLAN FOR PEDIATRIC MEDICAL DEVICE RE-
SEARCH.— 
(1) IN
GENERAL.—Not later than 180 days 
after the date of enactment of this Act, the Commis-
sioner of Food and Drugs, in collaboration with the 
Director of the National Institutes of Health and the 
Director of the Agency for Healthcare Research and 
Quality, 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 plan for expanding pedi-
atric medical device research and development. In 
developing such plan, the Commissioner of Food and 
Drugs shall consult with individuals and organiza-
tions with appropriate expertise in pediatric medical 
devices. 
(2) CONTENTS.—The plan under paragraph (1) 
shall include— 
(A) the current status of federally funded 
pediatric medical device research; 
(B) any gaps in such research, which may 
include a survey of pediatric medical providers 
regarding unmet pediatric medical device needs, 
as needed; and 
(C) a research agenda for improving pedi-
atric medical device development and Food and 
Drug Administration clearance or approval of 
pediatric medical devices, and for evaluating the 
short- and long-term safety and effectiveness of 
pediatric medical devices. 
SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDI-
ATRIC DEVICE AVAILABILITY. 
(a) IN GENERAL.— 
(1) REQUEST FOR PROPOSALS.—Not later than 
90 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue
a request for proposals for 1 or more grants or con-
tracts to nonprofit consortia for demonstration 
projects to promote pediatric device development. 
(2) DETERMINATION
ON
GRANTS
OR
CON-
TRACTS.—Not later than 180 days after the date the 
Secretary of Health and Human Services issues a 
request for proposals under paragraph (1), the Sec-
retary shall make a determination on the grants or 
contracts under this section. 
(b) APPLICATION.—A nonprofit consortium that de-
sires to receive a grant or contract under this section shall 
submit an application to the Secretary of Health and 
Human Services at such time, in such manner, and con-
taining such information as the Secretary may require. 
(c) USE OF FUNDS.—A nonprofit consortium that re-
ceives a grant or contract under this section shall— 
(1) encourage innovation by connecting quali-
fied individuals with pediatric device ideas with po-
tential manufacturers; 
(2) mentor and manage pediatric device 
projects through the development process, including 
product identification, prototype design, device devel-
opment, and marketing; 
(3) connect innovators and physicians to exist-
ing Federal resources, including resources from the
Food and Drug Administration, the National Insti-
tutes of Health, the Small Business Administration, 
the Department of Energy, the Department of Edu-
cation, the National Science Foundation, the De-
partment of Veterans Affairs, the Agency for 
Healthcare Research and Quality, and the National 
Institute of Standards and Technology; 
(4) assess the scientific and medical merit of 
proposed pediatric device projects; 
(5) assess business feasibility and provide busi-
ness advice; 
(6) provide assistance with prototype develop-
ment; and 
(7) provide assistance with postmarket needs, 
including training, logistics, and reporting. 
(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 of-
fice, designated under section 304; 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 in-
terest. 
(2) FOOD AND DRUG ADMINISTRATION.—Each 
consortium that receives a grant or contract under 
this section shall coordinate with the Commissioner 
of Food and Drugs and device companies to facili-
tate the application for approval or clearance of de-
vices labeled for pediatric use. 
(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 THERA-
PEUTICS AND PEDIATRIC ADVISORY COM-
MITTEE. 
(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 in-
creasing pediatric access to medical devices’’ after ‘‘pedi-
atric issues’’. 
(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 ‘‘(in-
cluding drugs and biological products) and med-
ical devices’’ after ‘‘therapeutics’’; 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 re-
lated to therapeutics (including drugs and bio-
logical products) and medical devices for pedi-
atric 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 STUDIES. 
Section 522 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360l) is amended—
(1) in subsection (a)— 
(A) by inserting ‘‘, or as a condition to ap-
proval of an application (or a supplement to an 
application) or a product development protocol 
under section 515 or as a condition to clearance 
of a premarket notification under section 
510(k), for a pediatric population or pediatric 
subpopulation,’’ after ‘‘The Secretary may by 
order’’; and 
(B) by inserting ‘‘, or that is indicated for 
pediatric populations or subpopulations or is ex-
pected to have significant use in pediatric popu-
lations,’’ after ‘‘health consequences’’; and 
(2) in subsection (b)— 
(A) by striking ‘‘(b) SURVEILLANCE AP-
PROVAL.—Each’’ and inserting the following: 
‘‘(b) SURVEILLANCE APPROVAL.— 
‘‘(1) IN GENERAL.—Each’’; 
(B) by striking ‘‘The Secretary, in con-
sultation’’ and inserting ‘‘Except as provided in 
paragraph (2), the Secretary, 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
STUDIES
FOR
PEDIATRIC
DE-
VICES.—The Secretary may by order require a pro-
spective surveillance period of more than 36 months 
with respect to a device that is expected to have sig-
nificant 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 de-
vice. 
‘‘(c) DISPUTE RESOLUTION.—A manufacturer may 
request review under section 562 of any order or condition 
requiring postmarket surveillance under this section. Dur-
ing the pendency of such review, the device subject to such 
a postmarket surveillance order or condition shall not be 
deemed misbranded under section 502(t) or otherwise in 
violation of such order or condition or a related require-
ment of this Act 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’’.
100 
SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQ-
UITY ACT. 
(a) IN GENERAL.—Section 505B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amend-
ed 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 enactment of the Pediatric Re-
search Equity Act of 2007, an application (or sup-
plement to an application)— 
‘‘(A) under section 505 for a new active in-
gredient, 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 indication, new dosage 
form, new dosing regimen, or new route of ad-
ministration, 
shall submit with the application the assessments de-
scribed in paragraph (2). 
‘‘(2) ASSESSMENTS.— 
‘‘(A) IN GENERAL.—The assessments re-
ferred to in paragraph (1) shall contain data,
101 
gathered using appropriate formulations for 
each age group for which the assessment is re-
quired, that are adequate— 
‘‘(i) to assess the safety and effective-
ness of the drug or the biological product 
for the claimed indications in all relevant 
pediatric subpopulations; and 
‘‘(ii) to support dosing and adminis-
tration 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 pediatric patients, 
such as pharmacokinetic studies. 
‘‘(ii) EXTRAPOLATION BETWEEN AGE 
GROUPS.—A study may not be needed in
102 
each pediatric age group if data from one 
age group can be extrapolated to another 
age group. 
‘‘(iii) INFORMATION
ON
EXTRAPO-
LATION.—A brief documentation of the sci-
entific data supporting the conclusion 
under clauses (i) and (ii) shall be included 
in the medical review that is collected as 
part of the application under section 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 paragraph (1) 
until a specified date after approval of the drug 
or issuance of the license for a biological prod-
uct if— 
‘‘(i) the Secretary finds that— 
‘‘(I) the drug or biological prod-
uct is ready for approval for use in 
adults before pediatric studies are 
complete;
103 
‘‘(II) pediatric studies should be 
delayed until additional safety or ef-
fectiveness data have been collected; 
or 
‘‘(III) there is another appro-
priate reason for deferral; and 
‘‘(ii) the applicant submits to the Sec-
retary— 
‘‘(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 conducted or will be con-
ducted with due diligence and at the 
earliest possible time; and 
‘‘(IV) a timeline for the comple-
tion 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 following 
information:
104 
‘‘(I) Information detailing the 
progress made in conducting pediatric 
studies. 
‘‘(II) If no progress has been 
made in conducting such studies, evi-
dence and documentation that such 
studies will be conducted with due 
diligence and at the earliest possible 
time. 
‘‘(ii) PUBLIC AVAILABILITY.—The in-
formation submitted through the annual 
review under clause (i) shall promptly be 
made available to the public in an easily 
accessible manner, including through the 
website of the Food and Drug Administra-
tion. 
‘‘(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 ap-
propriate, of the requirement to submit assess-
ments for a drug or biological product under 
this subsection if the applicant certifies and the 
Secretary finds that—
105 
‘‘(i) necessary studies are impossible 
or highly impracticable (because, for exam-
ple, the number of patients is so small or 
the patients are geographically dispersed); 
‘‘(ii) there is evidence strongly sug-
gesting that the drug or biological product 
would be ineffective or unsafe in all pedi-
atric age groups; or 
‘‘(iii) The drug or biological product— 
‘‘(I) does not represent a mean-
ingful therapeutic benefit over existing 
therapies for pediatric patients; and 
‘‘(II) is not likely to be used in a 
substantial number of pediatric pa-
tients. 
‘‘(B) PARTIAL WAIVER.—On the initiative 
of the Secretary or at the request of an appli-
cant, the Secretary shall grant a partial waiver, 
as appropriate, of the requirement to submit as-
sessments 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 exam-
106 
ple, 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 sug-
gesting 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 mean-
ingful therapeutic 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 pa-
tients in that age group; or 
‘‘(iv) the applicant can demonstrate 
that reasonable attempts to produce a pe-
diatric formulation necessary for that age 
group have failed. 
‘‘(C) PEDIATRIC FORMULATION NOT POS-
SIBLE.—If a waiver is granted on the ground 
that it is not possible to develop a pediatric for-
mulation, the waiver shall cover only the pedi-
atric groups requiring that formulation. An ap-
plicant seeking either a full or partial waiver
107 
shall submit to the Secretary documentation de-
tailing why a pediatric formulation cannot be 
developed and, if the waiver is granted, the ap-
plicant’s submission shall promptly be made 
available to the public in an easily accessible 
manner, including through posting on the 
website 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 prod-
uct would be ineffective or unsafe in pediatric 
populations, the information shall be included 
in the labeling for the drug or biological prod-
uct. 
‘‘(b) MARKETED DRUGS
AND BIOLOGICAL PROD-
UCTS.— 
‘‘(1) IN GENERAL.—Beginning on the date of 
enactment of the Pediatric Research Equity Act of 
2007, after providing notice in the form of a letter 
and an opportunity for written response and a meet-
ing, which may include an advisory committee meet-
ing, 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 hold-
er of a license for a biological product under section
108 
351 of the Public Health Service Act to submit by 
a specified date the assessments described in sub-
section (a)(2), if the Secretary finds that— 
‘‘(A)(i) the drug or biological product is 
used for a substantial number of pediatric pa-
tients for the labeled indications; and 
‘‘(ii) adequate pediatric labeling could con-
fer a benefit on pediatric patients; 
‘‘(B) there is reason to believe that the 
drug or biological product would represent a 
meaningful therapeutic benefit over existing 
therapies for pediatric patients for 1 or more of 
the claimed indications; or 
‘‘(C) the absence of adequate pediatric la-
beling could pose a risk to pediatric patients. 
‘‘(2) WAIVERS.— 
‘‘(A) FULL WAIVER.—At the request of an 
applicant, the Secretary shall grant a full waiv-
er, as appropriate, of the requirement to submit 
assessments under this subsection if the appli-
cant certifies and the Secretary finds that— 
‘‘(i) necessary studies are impossible 
or highly impracticable (because, for exam-
ple, the number of patients in that age