Sec. 4. Additional extension of exclusivity period for qualified infectious disease 
products for which a companion diagnostic test is cleared or 
approved. 
Sec. 5. Priority review. 
Sec. 6. Fast track product. 
Sec. 7. Study on incentives for qualified infectious disease biological products. 
Sec. 8. Clinical trials. 
SEC. 3. 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: 
‘‘SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW 
QUALIFIED INFECTIOUS DISEASE PRODUCTS. 
‘‘(a) EXTENSION.—If, prior to approval of a drug 
pursuant to an application submitted under section 
505(b), the Secretary determines that the drug is a quali-
fied infectious disease product, 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 de-
scribed 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 appli-
cable, 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— 
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‘‘(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; or 
‘‘(2) a subsequent application filed by the same 
sponsor or manufacturer of a qualified infectious 
disease product described in paragraph (1) (or a li-
censor, predecessor in interest, or other related enti-
ty) for— 
‘‘(A) a change (not including a modifica-
tion to the structure of the qualified infectious 
disease product) that results in a new indica-
tion, route of administration, dosing schedule, 
dosage form, delivery system, delivery device, or 
strength; or 
‘‘(B) a modification to the structure of the 
qualified infectious disease product that does 
not result in a change in safety or effectiveness. 
‘‘(d) DETERMINATION.—The manufacturer or spon-
sor of a drug may request the Secretary to designate a 
drug as a qualified infectious disease product. Such a re-
quest for designation shall be made at least 45 days before 
the submission of an application under section 505(b) for 
such drug. The Secretary shall, not later than 30 days 
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after the submission of such request, determine whether 
the drug is a qualified infectious disease product. 
‘‘(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 antibiotic drug for treating, detecting, 
preventing, or identifying 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) multi-drug resistant gram negative 
bacteria, including Acinetobacter, Klebsiella, 
Pseudomonas, and E. coli species; 
‘‘(C) multi-drug resistant tuberculosis; or 
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‘‘(D) any other infectious pathogen identi-
fied for purposes of this section by the Sec-
retary.’’. 
(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. 4. ADDITIONAL EXTENSION OF EXCLUSIVITY PERIOD 
FOR QUALIFIED INFECTIOUS DISEASE PROD-
UCTS FOR WHICH A COMPANION DIAGNOSTIC 
TEST IS CLEARED OR APPROVED. 
The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.), as amended by section 3, is further 
amended by inserting after section 505E the following: 
‘‘SEC. 505E–1. ADDITIONAL EXTENSION OF EXCLUSIVITY 
FOR QUALIFIED INFECTIOUS DISEASE PROD-
UCTS FOR WHICH A COMPANION DIAGNOSTIC 
TEST IS CLEARED OR APPROVED. 
‘‘(a) IN GENERAL.—If the sponsor or manufacturer 
of a qualified infectious disease product identifies in ac-
cordance with subsection (b) a companion diagnostic test 
described in subsection (c), any period extended under sec-
tion 505E(a) with respect to such product shall be further 
extended by 6 months. 
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‘‘(b) IDENTIFICATION REQUIREMENTS.—For pur-
poses of subsection (a), the identification of a companion 
diagnostic test shall— 
‘‘(1) be made in such manner as the Secretary 
may require; and 
‘‘(2) occur before the expiration of the period to 
be extended under subsection (a), not counting any 
extension to such period under section 505E(a) or 
505A. 
‘‘(c) COMPANION DIAGNOSTIC TEST.—For purposes 
of subsection (a), a device is a companion diagnostic test 
with respect to a qualified infectious disease product if 
each of the following is met: 
‘‘(1) The device is determined by the Secretary 
under subsection (f) to be a test for diagnosis of a 
qualifying pathogen. 
‘‘(2) The qualified infectious disease product 
has been determined under section 505E(d) to be for 
treating, detecting, preventing, or identifying such 
qualifying pathogen. 
‘‘(3) The device is cleared under section 510(k) 
or approved under section 515. 
‘‘(4) The sponsor or manufacturer, as applica-
ble, of the qualified infectious disease product has 
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the exclusive rights to submit an identification under 
subsection (a) with respect to the device. 
‘‘(d) RELATION TO PEDIATRIC EXCLUSIVITY.—Any 
extension under subsection (a) of a period with respect 
to a qualified infectious disease product shall be in addi-
tion to any extension of the period under section 505A 
of this Act with respect to the product. 
‘‘(e) LIMITATIONS.—After the extension of any pe-
riod under subsection (a) with respect to a qualified infec-
tious disease product pursuant to the identification of a 
device as a companion diagnostic test, subsection (a) does 
not authorize— 
‘‘(1) any subsequent extension with respect to 
such product; or 
‘‘(2) any extension with respect to any other 
product pursuant to identification of such device. 
‘‘(f) DETERMINATION.—The sponsor or manufac-
turer of a drug may request the Secretary to determine 
that a device is a test for diagnosis of a qualifying patho-
gen. Such a request shall be made at least 45 days before 
the submission of a notification under section 510(k) or 
an application under section 515 for such device. The Sec-
retary shall, not later than 30 days after the submission 
of such request, determine whether the device is a test 
for diagnosis of a qualifying pathogen. 
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