‘‘(iii) The actual amount of such rare 
pediatric disease product distributed in the 
United States. 
‘‘(B) PUBLICATION
UPON
FAILURE
TO 
DEMONSTRATE GOOD FAITH EFFORT TO MAR-
KET.—The Secretary may publish the results of 
a report submitted under subparagraph (A) in 
the Federal Register if the Secretary finds that 
the sponsor that submitted such report has not 
made a good faith effort to meet the demand in 
the United States for the product that is the 
subject of such report during each of the first 
4 years after approval of such product. 
‘‘(f) PRODUCTION REPORT FOR TROPICAL DISEASE 
PRODUCTS.— 
‘‘(1) REPORT REQUIRED.—The sponsor of an 
approved tropical disease product shall submit a re-
port to the Secretary not later than 5 years after the 
approval of the applicable rare tropical disease prod-
uct application. Such report shall provide the fol-
lowing information, with respect to each of the first 
4 years after approval of such product: 
‘‘(A) The estimated global population suf-
fering from the tropical disease. 
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‘‘(B) The estimated global demand for 
such tropical disease product. 
‘‘(C) The actual amount of such tropical 
disease product distributed globally. 
‘‘(2) PUBLICATION
UPON
FAILURE
TO
DEM-
ONSTRATE GOOD FAITH EFFORT TO MARKET.—The 
Secretary may publish the results of a report sub-
mitted under paragraph (1) in the Federal Register 
if the Secretary finds that the sponsor that sub-
mitted such report has not made a good faith effort 
to meet the global demand for the product that is 
the subject of such report during each of the first 
4 years after approval of such product. 
‘‘(g) NOTICE OF ISSUANCE AND USE OF VOUCHER.— 
The Secretary shall publish a notice in the Federal Reg-
ister and on the Web site of the Food and Drug Adminis-
tration not later than 30 days after the occurrence of each 
of the following: 
‘‘(1) The Secretary issues a priority review 
voucher under this section. 
‘‘(2) A sponsor submits a human drug applica-
tion for which such sponsor uses a priority review 
voucher. 
‘‘(h) ELIGIBILITY FOR OTHER PROGRAMS.—A spon-
sor who seeks a priority review voucher under this section 
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may participate in any other incentive program, including 
the programs the Secretary has implemented under this 
Act, if the sponsor meets the applicable criteria of such 
other incentive program. 
‘‘(i) RELATION TO OTHER PROVISIONS.—The provi-
sions of this section shall supplement, not supplant, any 
other provisions of this Act or the Public Health Service 
Act that encourage the development of drugs for tropical 
diseases and rare pediatric diseases.’’. 
(f) CONFORMING AMENDMENT.—Section 740(b) of 
the Agricultural, Rural Development, Food and Drug Ad-
ministration, and Related Agencies Appropriations Act, 
2010 (21 U.S.C. 360aa note) is amended by striking 
‘‘(a)(3)’’ each place such term appears and inserting 
‘‘(a)(6)’’. 
SEC. 3. EFFECTIVE DATE. 
This Act (and the amendments made by this Act) 
shall take effect on the date that is 90 days after the date 
of enactment of this Act. 
Æ 
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