200 
(d) REGULATIONS.— 
(1) IN GENERAL.—Not later than 36 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services, in consulta-
tion with the Secretary of Homeland Security acting 
through U.S. Customs and Border Protection, shall 
promulgate the regulations required to carry out sec-
tion 801(s) of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (b). 
(2) EFFECTIVE DATE.—In establishing the ef-
fective date of the regulations under paragraph (1), 
the Secretary of Health and Human Services shall, 
in consultation with the Secretary of Homeland Se-
curity acting through U.S. Customs and Border Pro-
tection, as determined appropriate by the Secretary 
of Health and Human Services, provide a reasonable 
period of time for an importer of a drug to comply 
with good importer practices, taking into account 
differences among importers and types of imports, 
including based on the level of risk posed by the im-
ported product. 
SEC. 811. NOTIFICATION. 
(a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 
331), as amended by section 811, is further amended by 
adding at the end the following: 
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‘‘(bbb) The failure to notify the Secretary in violation 
of section 568.’’. 
(b) NOTIFICATION.—Subchapter E of chapter V (21 
U.S.C. 360bbb et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 568 NOTIFICATION. 
‘‘(a) NOTIFICATION TO SECRETARY.—With respect 
to a drug, the Secretary may require notification to the 
Secretary by a regulated person if the regulated person 
knows— 
‘‘(1) that the use of such drug in the United 
States may result in serious injury or death; 
‘‘(2) of a significant loss or known theft of such 
drug intended for use in the United States; or 
‘‘(3) that— 
‘‘(A) such drug has been or is being coun-
terfeited; and 
‘‘(B)(i) the counterfeit product is in com-
merce in the United States or could be reason-
ably expected to be introduced into commerce; 
or 
‘‘(ii) such drug has been or is being im-
ported into the United States or may reason-
ably be expected to be offered for import into 
the United States. 
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‘‘(b) 
MANNER
OF
NOTIFICATION.—Notification 
under this section shall be made in such manner and by 
such means as the Secretary may specify by regulation 
or guidance. 
‘‘(c) SAVINGS CLAUSE.—Nothing in this section shall 
be construed as limiting any other authority of the Sec-
retary to require notifications related to a drug under any 
other provision of this Act or the Public Health Service 
Act. 
‘‘(d) DEFINITION.—In this section, the term ‘regu-
lated person’ means— 
‘‘(1) a person who is required to register under 
section 510 or 801(s); 
‘‘(2) a wholesale distributor of a drug product; 
or 
‘‘(3) any other person that distributes drugs ex-
cept a person that distributes drugs exclusively for 
retail sale.’’. 
SEC. 812. EXCHANGE OF INFORMATION. 
Section 708 (21 U.S.C. 379) is amended— 
(1) by striking ‘‘The Secretary may provide’’ 
and inserting the following: 
‘‘(a) CONTRACTORS.—The Secretary may provide’’; 
and 
(2) by adding at the end the following: 
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‘‘(b) ABILITY TO RECEIVE
AND PROTECT CON-
FIDENTIAL INFORMATION.—Except pursuant to an order 
of a court of the United States, the Secretary shall not 
be required to disclose under section 552 of title 5, United 
States Code, or any other provision of law, any informa-
tion relating to drugs obtained from a Federal, State, or 
local government agency, or from a foreign government 
agency, if the agency has requested that the information 
be kept confidential. For purposes of section 552 of title 
5, United States Code, this subsection shall be considered 
a statute described in section 552(b)(3)(B). 
‘‘(c) AUTHORITY TO ENTER INTO MEMORANDA OF 
UNDERSTANDING FOR PURPOSES OF INFORMATION EX-
CHANGE.—The Secretary may enter into written agree-
ments regarding the exchange of information referenced 
in section 301(j) subject to the following criteria: 
‘‘(1) CERTIFICATION.—The Secretary may only 
enter into written agreements under this subsection 
with foreign governments that the Secretary has cer-
tified as having the authority and demonstrated abil-
ity to protect trade secret information from disclo-
sure. Responsibility for this certification shall not be 
delegated to any officer or employee other than the 
Commissioner of Food and Drugs. 
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‘‘(2) 
WRITTEN
AGREEMENT.—The 
written 
agreement under this subsection shall include a com-
mitment by the foreign government to protect infor-
mation exchanged under this subsection from disclo-
sure unless and until the sponsor gives written per-
mission for disclosure or the Secretary makes a dec-
laration of a public health emergency pursuant to 
section 319 of the Public Health Service Act that is 
relevant to the information. 
‘‘(3) INFORMATION EXCHANGE.—The Secretary 
may provide to a foreign government that has been 
certified under paragraph (1), and that has executed 
a written agreement under paragraph (2), informa-
tion referenced in section 301(j) in the following cir-
cumstances: 
‘‘(A) Information concerning the inspection 
of a facility may be provided if— 
‘‘(i) the Secretary reasonably believes, 
or the written agreement described in 
paragraph (2) establishes, that the govern-
ment has authority to otherwise obtain 
such information; and 
‘‘(ii) the written agreement executed 
under paragraph (2) limits the recipient’s 
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use of the information to the recipient’s 
civil regulatory purposes. 
‘‘(B) Information not described in sub-
paragraph (A) may be provided as part of an 
investigation, or to alert the foreign government 
to the potential need for an investigation, if the 
Secretary has reasonable grounds to believe 
that a drug has a reasonable probability of 
causing serious adverse health consequences or 
death. 
‘‘(d) NO LIMITATION ON AUTHORITY.—This section 
shall not affect the authority of the Secretary to provide 
or disclose information under any other provision of law.’’. 
SEC. 813. EXTRATERRITORIAL JURISDICTION. 
Chapter III (21 U.S.C. 331 et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 311. EXTRATERRITORIAL JURISDICTION. 
‘‘There is extraterritorial jurisdiction over any viola-
tion of this Act relating to any article regulated under this 
Act if such article was intended for import into the United 
States or if any act in furtherance of the violation was 
committed in the United States.’’. 
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206 
SEC. 814. PROTECTION AGAINST INTENTIONAL ADULTERA-
TION. 
Section 303(b) (21 U.S.C. 333(b)) is amended by 
adding at the end the following: 
‘‘(7) Notwithstanding subsection (a)(2), any 
person that knowingly and intentionally engages in 
an activity that results in a drug becoming adulter-
ated under subsection (a)(1), (b), (c), or (d) of sec-
tion 501 and having a reasonable probability of 
causing serious adverse health consequences or 
death shall be imprisoned for not more than 20 
years or fined not more than $1,000,000, or both.’’. 
SEC. 815. RECORDS FOR INSPECTION. 
Section 704(a) (21 U.S.C. 374(a)) is amended by 
adding at the end the following: 
‘‘(4)(A) Any records or other information that the 
Secretary may inspect under this section from a person 
that owns or operates an establishment that is engaged 
in 
the 
manufacture, 
preparation, 
propagation, 
compounding, or processing of a drug shall, upon the re-
quest of the Secretary, be provided to the Secretary by 
such person, in advance of or in lieu of an inspection, with-
in a reasonable timeframe, within reasonable limits, and 
in a reasonable manner, and in either electronic or phys-
ical form, at the expense of such person. The Secretary’s 
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request shall include a sufficient description of the records 
requested. 
‘‘(B) Upon receipt of the records requested under 
subparagraph (A), the Secretary shall provide to the per-
son confirmation of receipt. 
‘‘(C) Nothing in this paragraph supplants the author-
ity of the Secretary to conduct inspections otherwise per-
mitted under this Act in order to ensure compliance with 
this Act.’’. 
Subtitle B—Medical Gas Safety 
SEC. 821. REGULATION OF MEDICAL GASES. 
Chapter V (21 U.S.C. 351 et seq.) is amended by 
adding at the end the following: 
‘‘Subchapter G—Medical Gases 
‘‘SEC. 575. DEFINITIONS. 
‘‘In this subchapter: 
‘‘(1) The term ‘designated medical gas’ means 
any of the following: 
‘‘(A) Oxygen that meets the standards set 
forth in an official compendium. 
‘‘(B) Nitrogen that meets the standards 
set forth in an official compendium. 
‘‘(C) Nitrous oxide that meets the stand-
ards set forth in an official compendium. 
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208 
‘‘(D) Carbon dioxide that meets the stand-
ards set forth in an official compendium. 
‘‘(E) Helium that meets the standards set 
forth in an official compendium. 
‘‘(F) Carbon monoxide that meets the 
standards set forth in an official compendium. 
‘‘(G) Medical air that meets the standards 
set forth in an official compendium. 
‘‘(H) Any other medical gas deemed appro-
priate by the Secretary, after taking into ac-
count any investigational new drug application 
or investigational new animal drug application 
for the same medical gas submitted in accord-
ance with regulations applicable to such appli-
cations in title 21 of the Code of Federal Regu-
lations, unless any period of exclusivity under 
section 
505(c)(3)(E)(ii) 
or 
section 
505(j)(5)(F)(ii), or the extension of any such 
period under section 505A, applicable to such 
medical gas has not expired. 
‘‘(2) The term ‘medical gas’ means a drug 
that— 
‘‘(A) is manufactured or stored in a lique-
fied, nonliquefied, or cryogenic state; and 
‘‘(B) is administered as a gas. 
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209 
‘‘SEC. 576. REGULATION OF MEDICAL GASES. 
‘‘(a) CERTIFICATION
OF
DESIGNATED
MEDICAL 
GASES.— 
‘‘(1) SUBMISSION.—Beginning 180 days after 
the date of enactment of this section, any person 
may file with the Secretary a request for certifi-
cation of a medical gas as a designated medical gas. 
Any such request shall contain the following infor-
mation: 
‘‘(A) A description of the medical gas. 
‘‘(B) The name and address of the spon-
sor. 
‘‘(C) The name and address of the facility 
or facilities where the medical gas is or will be 
manufactured. 
‘‘(D) Any other information deemed appro-
priate by the Secretary to determine whether 
the medical gas is a designated medical gas. 
‘‘(2) GRANT OF CERTIFICATION.—The certifi-
cation requested under paragraph (1) is deemed to 
be granted unless, within 60 days of the filing of 
such request, the Secretary finds that— 
‘‘(A) the medical gas subject to the certifi-
cation is not a designated medical gas; 
‘‘(B) the request does not contain the in-
formation required under paragraph (1) or oth-
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210 
erwise lacks sufficient information to permit the 
Secretary to determine that the medical gas is 
a designated medical gas; or 
‘‘(C) denying the request is necessary to 
protect the public health. 
‘‘(3) EFFECT OF CERTIFICATION.— 
‘‘(A) IN GENERAL.— 
‘‘(i) APPROVED USES.—A designated 
medical gas for which a certification is 
granted under paragraph (2) is deemed, 
alone or in combination, as medically ap-
propriate, with another designated medical 
gas or gases for which a certification or 
certifications have been granted, to have in 
effect an approved application under sec-
tion 505 or 512, subject to all applicable 
post-approval requirements, for the fol-
lowing indications for use: 
‘‘(I) In the case of oxygen, the 
treatment or prevention of hypoxemia 
or hypoxia. 
‘‘(II) In the case of nitrogen, use 
in hypoxic challenge testing. 
‘‘(III) In the case of nitrous 
oxide, analgesia. 
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‘‘(IV) In the case of carbon diox-
ide, use in extracorporeal membrane 
oxygenation therapy or respiratory 
stimulation. 
‘‘(V) In the case of helium, the 
treatment of upper airway obstruction 
or increased airway resistance. 
‘‘(VI) In the case of medical air, 
to reduce the risk of hyperoxia. 
‘‘(VII) In the case of carbon 
monoxide, use in lung diffusion test-
ing. 
‘‘(VIII) Any other indication for 
use for a designated medical gas or 
combination of designated medical 
gases deemed appropriate by the Sec-
retary, unless any period of exclusivity 
under clause (iii) or (iv) of section 
505(c)(3)(E), clause (iii) or (iv) of 
section 505(j)(5)(F), or section 527, 
or the extension of any such period 
under section 505A, applicable to 
such indication for use for such gas or 
combination of gases has not expired. 
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‘‘(ii) LABELING.—The requirements 
of sections 503(b)(4) and 502(f) are 
deemed to have been met for a designated 
medical gas if the labeling on final use 
container for such medical gas bears— 
‘‘(I) the information required by 
section 503(b)(4); 
‘‘(II) a warning statement con-
cerning the use of the medical gas as 
determined by the Secretary by regu-
lation; and 
‘‘(III) appropriate directions and 
warnings concerning storage and han-
dling. 
‘‘(B) INAPPLICABILITY
OF
EXCLUSIVITY 
PROVISIONS.— 
‘‘(i) NO
EXCLUSIVITY
FOR
A
CER-
TIFIED
MEDICAL
GAS.—No designated 
medical gas deemed under subparagraph 
(A)(i) to have in effect an approved appli-
cation is eligible for any period of exclu-
sivity under section 505(c), 505(j), or 527, 
or the extension of any such period under 
section 505A, on the basis of such deemed 
approval. 
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‘‘(ii) EFFECT
ON
CERTIFICATION.— 
No period of exclusivity under section 
505(c), 505(j), or section 527, or the ex-
tension of any such period under section 
505A, with respect to an application for a 
drug product shall prohibit, limit, or other-
wise affect the submission, grant, or effect 
of a certification under this section, except 
as provided in subsection (a)(3)(A)(i)(VIII) 
and section 575(1)(H). 
‘‘(4) WITHDRAWAL, SUSPENSION, OR REVOCA-
TION OF APPROVAL.— 
‘‘(A) WITHDRAWAL, SUSPENSION
OF
AP-
PROVAL.—Nothing in this subchapter limits the 
Secretary’s authority to withdraw or suspend 
approval of a drug product, including a des-
ignated medical gas deemed under this section 
to have in effect an approved application under 
section 505 or section 512 of this Act. 
‘‘(B) REVOCATION
OF
CERTIFICATION.— 
The Secretary may revoke the grant of a certifi-
cation under paragraph (2) if the Secretary de-
termines that the request for certification con-
tains any material omission or falsification. 
‘‘(b) PRESCRIPTION REQUIREMENT.— 
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214 
‘‘(1) IN GENERAL.—A designated medical gas 
shall be subject to the requirements of section 
503(b)(1) unless the Secretary exercises the author-
ity provided in section 503(b)(3) to remove such 
medical gas from the requirements of section 
503(b)(1), the gas is approved for use without a pre-
scription pursuant to an application under section 
505 or 512, or the use in question is authorized pur-
suant to another provision of this Act relating to use 
of medical products in emergencies. 
‘‘(2) OXYGEN.— 
‘‘(A) NO
PRESCRIPTION
REQUIRED
FOR 
CERTAIN
USES.—Notwithstanding paragraph 
(1), oxygen may be provided without a prescrip-
tion for the following uses: 
‘‘(i) For use in the event of depres-
surization or other environmental oxygen 
deficiency. 
‘‘(ii) For oxygen deficiency or for use 
in emergency resuscitation, when adminis-
tered by properly trained personnel. 
‘‘(B) LABELING.—For oxygen provided 
pursuant to subparagraph (A), the require-
ments of section 503(b)(4) shall be deemed to 
have been met if its labeling bears a warning 
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215 
that the oxygen can be used for emergency use 
only and for all other medical applications a 
prescription is required. 
‘‘SEC. 577. INAPPLICABILITY OF DRUG FEES TO DES-
IGNATED MEDICAL GASES. 
‘‘A designated medical gas, alone or in combination 
with another designated gas or gases (as medically appro-
priate) deemed under section 576 to have in effect an ap-
proved application shall not be assessed fees under section 
736(a) on the basis of such deemed approval.’’. 
SEC. 822. CHANGES TO REGULATIONS. 
(a) REPORT.—Not later than 18 months after the 
date of the enactment of this Act, the Secretary, after ob-
taining input from medical gas manufacturers and any 
other interested members of the public, shall— 
(1) determine whether any changes to the Fed-
eral drug regulations are necessary for medical 
gases; and 
(2) submit to the Committee on Health, Edu-
cation, Labor and Pensions of the Senate and the 
Committee on Energy and Commerce of the House 
of Representatives a report regarding any such 
changes. 
(b) REGULATIONS.—If the Secretary determines 
under subsection (a) that changes to the Federal drug reg-
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216 
ulations are necessary for medical gases, the Secretary 
shall issue final regulations revising the Federal drug reg-
ulations with respect to medical gases not later than 48 
months after the date of the enactment of this Act. 
(c) DEFINITIONS.—In this section: 
(1) The term ‘‘Federal drug regulations’’ means 
regulations in title 21 of the Code of Federal Regu-
lations pertaining to drugs. 
(2) The term ‘‘medical gas’’ has the meaning 
given to such term in section 575 of the Federal 
Food, Drug, and Cosmetic Act, as added by section 
821 of this Act. 
(3) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services, acting through the 
Commissioner of Food and Drugs. 
SEC. 823. RULES OF CONSTRUCTION. 
Nothing in this subtitle and the amendments made 
by this subtitle applies with respect to— 
(1) a drug that is approved prior to May 1, 
2012, pursuant to an application submitted under 
section 505 or 512 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355, 360b); 
(2) any gas listed in subparagraphs (A) through 
(G) of section 575(1) of the Federal Food, Drug, 
and Cosmetic Act, as added by section 821 of this 
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217 
Act, or any combination of any such gases, for an 
indication that— 
(A) is not included in, or is different from, 
those specified in subclauses (I) through (VII) 
of section 576(a)(3)(A)(i) of such Act; and 
(B) is approved on or after May 1, 2012, 
pursuant to an application submitted under 
Section 505 or 512; or 
(3) any designated medical gas added pursuant 
to subparagraph (H) of section 575(1) of such Act 
for an indication that— 
(A) is not included in, or is different from, 
those originally added pursuant to subpara-
graph (H) of section 575(1) and section 
576(a)(3)(A)(i)(VIII); and 
(B) is approved on or after May 1, 2012, 
pursuant to an application submitted under sec-
tion 505 or 512 of such Act. 
Subtitle C—Generating Antibiotic 
Incentives Now 
SEC. 831. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 505D 
(21 U.S.C. 355e) the following: 
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‘‘SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW 
QUALIFIED INFECTIOUS DISEASE PRODUCTS. 
‘‘(a) EXTENSION.—If the Secretary approves an ap-
plication pursuant to section 505 for a drug that has been 
determined to be a qualified infectious disease product 
under subsection (d), then the four- and five-year periods 
described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of 
section 505, the three-year periods described in clauses 
(iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and 
(iv) of subsection (j)(5)(F) of section 505, or the seven 
year period described in section 527, as applicable, shall 
be extended by five years. 
‘‘(b) RELATION TO PEDIATRIC EXCLUSIVITY.—Any 
extension under subsection (a) of a period shall be in addi-
tion to any extension of the period under section 505A 
with respect to the drug. 
‘‘(c) LIMITATIONS.—Subsection (a) does not apply to 
the approval of— 
‘‘(1) a supplement to an application under sec-
tion 505(b) for any qualified infectious disease prod-
uct for which an extension described in subsection 
(a) is in effect or has expired; 
‘‘(2) a subsequent application filed by the same 
sponsor or manufacturer of a qualified infectious 
disease product described in paragraph (1) (or a li-
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censor, predecessor in interest, or other related enti-
ty) for— 
‘‘(A) a change (not including a modifica-
tion to the active moiety of the qualified infec-
tious disease product) that results in a new in-
dication, route of administration, dosing sched-
ule, dosage form, delivery system, delivery de-
vice, or strength; or 
‘‘(B) a modification to the active moiety of 
the qualified infectious disease product that 
does not result in a change in safety or effec-
tiveness; or 
‘‘(3) a product that does not meet the definition 
of a qualified infectious disease product under sub-
section (f) based upon its approved uses. 
‘‘(d) DETERMINATION.—The manufacturer or spon-
sor of a drug may request that the Secretary designate 
a drug as a qualified infectious disease product at any 
time in the drug development process prior to the submis-
sion of an application under section 505(b) for the drug, 
but not later than 45 days before the submission of such 
application. The Secretary shall, not later than 30 days 
after the submission of such request, determine whether 
the drug is a qualified infectious disease product. 
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‘‘(e) REGULATIONS.—The Secretary shall promulgate 
regulations for carrying out this section. The Secretary 
shall promulgate the initial regulations for carrying out 
this section not later than 12 months after the date of 
the enactment of this section. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) QUALIFIED
INFECTIOUS
DISEASE
PROD-
UCT.—The term ‘qualified infectious disease prod-
uct’ means an antibacterial or antifungal drug for 
human use that treats or prevents an infection 
caused by a qualifying pathogen. 
‘‘(2) 
QUALIFYING
PATHOGEN.—The 
term 
‘qualifying pathogen’ means— 
‘‘(A) resistant gram-positive pathogens, in-
cluding 
methicillin-resistant 
Staphylococcus 
aureus (MRSA), vancomycin-resistant Staphy-
lococcus aureus (VRSA), and vancomycin-resist-
ant enterococcus (VRE); 
‘‘(B) multidrug resistant gram-negative 
bacteria, including Acinetobacter, Klebsiella, 
Pseudomonas, and E. coli species; 
‘‘(C) multi-drug resistant tuberculosis; or 
‘‘(D) any other infectious pathogen identi-
fied for purposes of this section by the Sec-
retary.’’. 
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(b) APPLICATION.—Section 505E of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(a), applies only with respect to a drug that is first ap-
proved under section 505(c) of such Act (21 U.S.C. 
355(c)) on or after the date of the enactment of this Act. 
SEC. 832. STUDY ON INCENTIVES FOR QUALIFIED INFEC-
TIOUS DISEASE BIOLOGICAL PRODUCTS. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall— 
(1) conduct a study on the need for incentives 
to encourage research on and development and mar-
keting of qualified infectious disease biological prod-
ucts; and 
(2) not later than 1 year after the date of the 
enactment of this Act, submit a report to the Con-
gress on the results of such study, including any rec-
ommendations of the Comptroller General on appro-
priate incentives for addressing such need. 
(b) DEFINITIONS.—In this section: 
(1) The term ‘‘biological product’’ has the 
meaning given to such term in section 351 of the 
Public Health Service Act (42 U.S.C. 262). 
(2) The term ‘‘qualified infectious disease bio-
logical product’’ means a biological product for 
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human use that treats or prevents an infection 
caused by a qualifying pathogen. 
(3) The term ‘‘qualifying pathogen’’ has the 
meaning given to such term in section 505E of the 
Federal Food, Drug, and Cosmetic Act, as added by 
section 831 of this Act. 
SEC. 833. CLINICAL TRIALS. 
(a) REVIEW AND REVISION OF GUIDELINES.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of this Act, and not later 
than 4 years thereafter, the Secretary shall— 
(A) review the guidance of the Food and 
Drug Administration for the conduct of clinical 
trials 
with 
respect 
to 
antibacterial 
and 
antifungal drugs; and 
(B) as appropriate, revise such guidance to 
reflect developments in scientific and medical 
information and technology and to ensure clar-
ity regarding the procedures and requirements 
for approval of an antibiotic and antifungal 
drug under chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et 
seq.). 
(2) ISSUES FOR REVIEW.—At a minimum, the 
review under paragraph (1) shall address the appro-
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priate animal models of infection, in vitro tech-
niques, valid microbiological surrogate markers, the 
use of noninferiority versus superiority trials, and 
appropriate delta values for noninferiority trials. 
(3) RULE OF CONSTRUCTION.—Except to the 
extent to which the Secretary of Health and Human 
Services makes revisions under paragraph (1)(B), 
nothing in this section shall be construed to repeal 
or otherwise affect the guidance of the Food and 
Drug Administration. 
(b) RECOMMENDATIONS FOR INVESTIGATIONS.— 
(1) REQUEST.—The sponsor of a drug intended 
to be used to treat or prevent a qualifying pathogen 
may request that the Secretary provide written rec-
ommendations for nonclinical and clinical investiga-
tions which may be conducted with the drug before 
it may be approved for such use under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355). 
(2) RECOMMENDATIONS.—If the Secretary has 
reason to believe that a drug for which a request is 
made under this subsection is a qualified infectious 
disease product, the Secretary shall provide the per-
son making the request written recommendations for 
the nonclinical and clinical investigations which the 
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Secretary believes, on the basis of information avail-
able to the Secretary at the time of the request, 
would be necessary for approval under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) of such drug for the use described in 
paragraph (1). 
(c) DEFINITIONS.—In this section: 
(1) The term ‘‘drug’’ has the meaning given to 
such term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321). 
(2) The term ‘‘qualified infectious disease prod-
uct’’ has the meaning given to such term in section 
505E of the Federal Food, Drug, and Cosmetic Act, 
as added by section 831 of this Act. 
(3) The term ‘‘qualifying pathogen’’ has the 
meaning given to such term in section 505E of the 
Federal Food, Drug, and Cosmetic Act, as added by 
section 831 of this Act. 
(4) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services, acting through the 
Commissioner of Food and Drugs. 
SEC. 834. REASSESSMENT OF QUALIFIED INFECTIOUS DIS-
EASE PRODUCT INCENTIVES IN 5 YEARS. 
Not later than five years after the date of enactment 
of this Act, the Secretary of Health and Human Services 
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shall, in consultation with the Food and Drug Administra-
tion, Centers for Disease Control and Prevention and 
other appropriate agencies, submit to the Committee on 
Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report that contains the fol-
lowing: 
(1)(A) The number of initial designations of 
drugs as qualified infectious disease products under 
section 505E of the Federal Food, Drug, and Cos-
metic Act; 
(B) the number of qualified infectious disease 
products approved under this program; and 
(C) whether such products address the need for 
antibacterial and antifungal drugs to treat serious 
and life-threatening infections. 
(2) Recommendations— 
(A) based on the information in paragraph 
(1) and any other relevant data, on any changes 
that should be made to the list of pathogens 
that are defined as qualifying pathogens under 
section 505E(f)(2) of the Federal Food, Drug, 
and Cosmetic Act, as added by section 831; and 
(B) on whether any additional program 
(such as the development of public-private col-
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laborations to advance antibacterial drug inno-
vation) or changes to the incentives under this 
subtitle may be needed to promote the develop-
ment of antibacterial drugs. 
(3) An examination of— 
(A) the adoption of programs to measure 
the use of antibacterial drugs in health care set-
tings; and 
(B) the implementation and effectiveness 
of antimicrobial stewardship protocols across all 
health care settings. 
(4) Any recommendations for ways to encour-
age further development and establishment of stew-
ardship programs. 
SEC. 
835. 
GUIDANCE 
ON 
PATHOGEN-FOCUSED 
ANTI-
BACTERIAL DRUG DEVELOPMENT. 
(a) DRAFT GUIDANCE.—Not later than June 30, 
2013, in order to facilitate the development of anti-
bacterial drugs for serious or life-threatening bacterial in-
fections, particularly in areas of unmet need, the Secretary 
of Health and Human Services shall publish draft guid-
ance that— 
(1) specifies how preclinical and clinical data 
can be utilized to inform an efficient and stream-
lined pathogen-focused antibacterial drug develop-
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ment program that meets the approval standards of 
the Food and Drug Administration; and 
(2) provides advice on approaches for the devel-
opment of antibacterial drugs that target a more 
limited spectrum of pathogens. 
(b) FINAL GUIDANCE.—Not later than December 31, 
2014, after notice and opportunity for public comment on 
the draft guidance under subsection (a), the Secretary of 
Health and Human Services shall publish final guidance 
consistent with this section. 
Subtitle D—Accelerated Approval 
SEC. 841. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS 
OR LIFE-THREATENING DISEASES OR CONDI-
TIONS. 
(a) FINDINGS; SENSE OF CONGRESS.— 
(1) FINDINGS.—The Congress finds as follows: 
(A) The Food and Drug Administration 
(referred to in this subsection as the ‘‘FDA’’) 
serves a critical role in helping to assure that 
new medicines are safe and effective. Regu-
latory innovation is 1 element of the Nation’s 
strategy to address serious and life-threatening 
diseases or conditions by promoting investment 
in and development of innovative treatments for 
unmet medical needs. 
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(B) During the 2 decades following the es-
tablishment of the accelerated approval mecha-
nism, advances in medical sciences, including 
genomics, molecular biology, and bioinformatics, 
have provided an unprecedented understanding 
of the underlying biological mechanism and 
pathogenesis of disease. A new generation of 
modern, targeted medicines is under develop-
ment to treat serious and life-threatening dis-
eases, some applying drug development strate-
gies based on biomarkers or pharmacogenomics, 
predictive toxicology, clinical trial enrichment 
techniques, and novel clinical trial designs, such 
as adaptive clinical trials. 
(C) As a result of these remarkable sci-
entific and medical advances, the FDA should 
be encouraged to implement more broadly effec-
tive processes for the expedited development 
and review of innovative new medicines in-
tended to address unmet medical needs for seri-
ous or life-threatening diseases or conditions, 
including those for rare diseases or conditions, 
using a broad range of surrogate or clinical 
endpoints and modern scientific tools earlier in 
the drug development cycle when appropriate. 
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This may result in fewer, smaller, or shorter 
clinical trials for the intended patient popu-
lation or targeted subpopulation without com-
promising or altering the high standards of the 
FDA for the approval of drugs. 
(D) Patients benefit from expedited access 
to safe and effective innovative therapies to 
treat unmet medical needs for serious or life- 
threatening diseases or conditions. 
(E) For these reasons, the statutory au-
thority in effect on the day before the date of 
enactment of this Act governing expedited ap-
proval of drugs for serious or life-threatening 
diseases or conditions should be amended in 
order to enhance the authority of the FDA to 
consider appropriate scientific data, methods, 
and tools, and to expedite development and ac-
cess to novel treatments for patients with a 
broad range of serious or life-threatening dis-
eases or conditions. 
(2) SENSE OF CONGRESS.—It is the sense of 
the Congress that the FDA should apply the acceler-
ated approval and fast track provisions set forth in 
section 506 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 356), as amended by this sec-
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230 
tion, to help expedite the development and avail-
ability to patients of treatments for serious or life- 
threatening diseases or conditions while maintaining 
safety and effectiveness standards for such treat-
ments. 
(b) EXPEDITED APPROVAL.—Section 506 (21 U.S.C. 
356) is amended to read as follows: 
‘‘SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS 
OR LIFE-THREATENING DISEASES OR CONDI-
TIONS. 
‘‘(a) DESIGNATION
OF DRUG
AS
A FAST TRACK 
PRODUCT.— 
‘‘(1) IN GENERAL.—The Secretary shall, at the 
request of the sponsor of a new drug, facilitate the 
development and expedite the review of such drug if 
it is intended, whether alone or in combination with 
one or more other drugs, for the treatment of a seri-
ous or life-threatening disease or condition, and it 
demonstrates the potential to address unmet medical 
needs for such a disease or condition. (In this sec-
tion, such a drug is referred to as a ‘fast track prod-
uct’.) 
‘‘(2) REQUEST FOR DESIGNATION.—The spon-
sor of a new drug may request the Secretary to des-
ignate the drug as a fast track product. A request 
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for the designation may be made concurrently with, 
or at any time after, submission of an application 
for the investigation of the drug under section 505(i) 
of this Act or section 351(a)(3) of the Public Health 
Service Act. 
‘‘(3) DESIGNATION.—Within 60 calendar days 
after the receipt of a request under paragraph (2), 
the Secretary shall determine whether the drug that 
is the subject of the request meets the criteria de-
scribed in paragraph (1). If the Secretary finds that 
the drug meets the criteria, the Secretary shall des-
ignate the drug as a fast track product and shall 
take such actions as are appropriate to expedite the 
development and review of the application for ap-
proval of such product. 
‘‘(b) ACCELERATED APPROVAL OF A DRUG FOR A 
SERIOUS OR LIFE-THREATENING DISEASE OR CONDI-
TION, INCLUDING A FAST TRACK PRODUCT.— 
‘‘(1) IN GENERAL.—The Secretary may approve 
an application for approval of a product for a seri-
ous or life-threatening disease or condition, including 
a fast track product, under section 505(c) of this 
Act or section 351(a) of the Public Health Service 
Act upon making a determination that the product 
has an effect on— 
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‘‘(A) a surrogate endpoint that is reason-
ably likely to predict clinical benefit; or 
‘‘(B) a clinical endpoint that can be meas-
ured earlier than irreversible morbidity or mor-
tality, that is reasonably likely to predict an ef-
fect on irreversible morbidity or mortality or 
other clinical benefit, 
taking into account the severity or rarity of the dis-
ease or condition and the availability of alternative 
treatments. The evidence to support that an end-
point is reasonably likely to predict clinical benefit 
may include epidemiological, pathophysiologic, phar-
macologic, therapeutic or other evidence developed 
using, for example, biomarkers, or other scientific 
methods or tools. 
‘‘(2) LIMITATION.—Approval of a product 
under this subsection may, as determined by the 
Secretary, be subject to the following require-
ments— 
‘‘(A) that the sponsor conduct appropriate 
post-approval studies to verify and describe the 
predicted effect of the product on irreversible 
morbidity or mortality or other clinical benefit; 
and 
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‘‘(B) that the sponsor submit copies of all 
promotional materials related to the product, at 
least 30 days prior to dissemination of the ma-
terials— 
‘‘(i) during the preapproval review pe-
riod; and 
‘‘(ii) following approval, for a period 
that the Secretary determines to be appro-
priate. 
‘‘(3) 
EXPEDITED
WITHDRAWAL
OF
AP-
PROVAL.—The Secretary may withdraw approval of 
a product approved pursuant to this subsection 
using expedited procedures (as prescribed by the 
Secretary in regulations, which shall include an op-
portunity for an informal hearing) if— 
‘‘(A) the sponsor fails to conduct any re-
quired post-approval study of the product with 
due diligence; 
‘‘(B) a study required to verify and de-
scribe the predicted effect on irreversible mor-
bidity or mortality or other clinical benefit of 
the product fails to verify and describe such ef-
fect or benefit; 
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‘‘(C) other evidence demonstrates that the 
product is not safe or effective under the condi-
tions of use; or 
‘‘(D) the sponsor disseminates false or 
misleading promotional materials with respect 
to the product. 
‘‘(c) REVIEW OF INCOMPLETE APPLICATIONS FOR 
APPROVAL OF A FAST TRACK PRODUCT.— 
‘‘(1) IN
GENERAL.—If the Secretary deter-
mines, after preliminary evaluation of clinical data 
submitted by the sponsor, that a fast track product 
may be effective, the Secretary shall evaluate for fil-
ing, and may commence review of portions of, an ap-
plication for the approval of the product before the 
sponsor submits a complete application. The Sec-
retary shall commence such review only if the appli-
cant— 
‘‘(A) provides a schedule for submission of 
information necessary to make the application 
complete; and 
‘‘(B) pays any fee that may be required 
under section 736. 
‘‘(2) EXCEPTION.—Any time period for review 
of human drug applications that has been agreed to 
by the Secretary and that has been set forth in goals 
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identified in letters of the Secretary (relating to the 
use of fees collected under section 736 to expedite 
the drug development process and the review of 
human drug applications) shall not apply to an ap-
plication submitted under paragraph (1) until the 
date on which the application is complete. 
‘‘(d) AWARENESS EFFORTS.—The Secretary shall— 
‘‘(1) develop and disseminate to physicians, pa-
tient 
organizations, 
pharmaceutical 
and 
bio-
technology companies, and other appropriate persons 
a description of the provisions of this section appli-
cable to accelerated approval and fast track prod-
ucts; and 
‘‘(2) establish a program to encourage the de-
velopment of surrogate and clinical endpoints, in-
cluding biomarkers, and other scientific methods and 
tools that can assist the Secretary in determining 
whether the evidence submitted in an application is 
reasonably likely to predict clinical benefit for seri-
ous or life-threatening conditions for which there 
exist significant unmet medical needs.’’. 
SEC. 842. GUIDANCE; AMENDED REGULATIONS. 
(a) INITIAL GUIDANCE.—Not later than one year 
after the date of enactment of this Act, the Secretary of 
Health and Human Services (in this subtitle referred to 
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236 
as the ‘‘Secretary’’) shall issue draft guidance to imple-
ment the amendment made by section 841. 
(b) FINAL GUIDANCE.—Not later than one year after 
the issuance of draft guidance under subsection (a), after 
an opportunity for public comment, the Secretary shall— 
(1) issue final guidance to implement the 
amendment made by section 841; and 
(2) amend the regulations governing accelerated 
approval in parts 314 and 601 of title 21, Code of 
Federal Regulations, as necessary to conform such 
regulations with the amendments made by section 
841. 
(c) CONSIDERATIONS.—In developing the guidance 
under subsections (a) and (b)(1) and the amendments 
under subsection (b)(2), the Secretary shall consider— 
(1) issues arising under the accelerated ap-
proval and fast track processes under section 506 of 
the Federal Food, Drug, and Cosmetic Act (as 
amended by section 841) for drugs designated for a 
rare disease or condition under section 526 of the 
Federal, Food, Drug, and Cosmetic Act; and 
(2) how to incorporate novel approaches to the 
review of surrogate endpoints based on patho-
physiologic and pharmacologic evidence in such guid-
ance, especially in instances where the low preva-
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lence of a disease renders the existence or collection 
of other types of data unlikely or impractical. 
(d) NO DELAY
IN REVIEW
OR APPROVAL.—The 
issuance (or non-issuance) of guidance or conforming reg-
ulations implementing the amendments made by section 
841 shall not preclude the review of, or action on, a re-
quest for designation or an application for approval sub-
mitted pursuant to section 506 of the Federal Food, Drug, 
and Cosmetic Act, as amended by section 841. 
SEC. 843. INDEPENDENT REVIEW. 
(a) IN GENERAL.—The Secretary may, in conjunc-
tion with other planned reviews of the new drug review 
process, contract with an independent entity with expertise 
in assessing the quality and efficiency of biopharma-
ceutical development and regulatory review programs, to 
evaluate the Food and Drug Administration’s application 
of the processes described in section 506 of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 
841, and the impact of such processes on the development 
and timely availability of innovative treatments for pa-
tients suffering from serious or life-threatening conditions. 
(b) CONSULTATION.—Any evaluation under sub-
section (a) shall include consultation with regulated indus-
tries, patient advocacy and disease research foundations, 
and relevant academic medical centers. 
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Subtitle E—Critical Path 
Reauthorization 
SEC. 851. REAUTHORIZATION OF THE CRITICAL PATH PUB-
LIC-PRIVATE PARTNERSHIPS. 
Subsection (f) of section 566 (21 U.S.C. 360bbb–5) 
is amended to read as follows: 
‘‘(f) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $6,000,000 for each of fiscal years 2013 through 
2017.’’. 
Subtitle F—Miscellaneous 
SEC. 861. REAUTHORIZATION OF PROVISION RELATING TO 
EXCLUSIVITY 
OF 
CERTAIN 
DRUGS 
CON-
TAINING SINGLE ENANTIOMERS. 
Section 505(u)(4) (21 U.S.C. 355(u)(4)) is amended 
by striking ‘‘2012’’ and inserting ‘‘2017’’. 
SEC. 862. EXTENSION OF PERIOD FOR FIRST APPLICANT TO 
OBTAIN 
TENTATIVE 
APPROVAL 
WITHOUT 
FORFEITING 180-DAY EXCLUSIVITY PERIOD. 
(a) EXTENSION OF PERIOD.— 
(1) IN
GENERAL.—Subclause (IV) of section 
505(j)(5)(D)(i) 
(21 
U.S.C. 
355(j)(5)(D)(i)) 
is 
amended to read as follows: 
‘‘(IV) FAILURE TO OBTAIN TEN-
TATIVE
APPROVAL.—The first appli-
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cant fails to obtain tentative approval 
of the application within 45 months 
after the date on which— 
‘‘(aa) the application is filed 
and initially contains a certifi-
cation described in paragraph 
(2)(A)(vii)(IV), or 
‘‘(bb) 
the 
application 
is 
amended to first contain such a 
certification, 
unless the failure is caused by a 
change in or a review of the require-
ments for approval of the application 
imposed after the date on which the 
application is so filed or amended.’’. 
(2) APPLICABILITY.— 
(A) IN GENERAL.—Subject to subsection 
(b), the amendment made by paragraph (1) ap-
plies— 
(i) only with respect to an application 
that is filed under section 505(j) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) on or after the day that is 
30 months prior to the date of the enact-
ment of this Act; and 
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under paragraph (1), the Secretary shall determine 
whether— 
‘‘(A) the disease or condition that is the 
subject of such request is a rare pediatric dis-
ease; and 
‘‘(B) the application for the new drug is a 
rare pediatric disease product application. 
‘‘(e) MARKETING
OF RARE PEDIATRIC DISEASE 
PRODUCTS.— 
‘‘(1) IN GENERAL.—The Secretary shall deem a 
rare pediatric disease product application incomplete 
if such application does not contain a description of 
the plan of the sponsor of such application to mar-
ket the product in the United States. 
‘‘(2) REVOCATION.—The Secretary may revoke 
any priority review voucher awarded under sub-
section (b) if the rare pediatric disease product for 
which such voucher was awarded is not marketed in 
the United States within the 365 day period begin-
ning on the date of the approval of such drug under 
section 505 of this Act or section 351 of the Public 
Health Service Act. 
‘‘(3) POSTAPPROVAL
PRODUCTION
REPORT.— 
The sponsor of an approved rare pediatric disease 
product shall submit a report to the Secretary not 
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