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GAIN Act as Introduced

GAIN Act as Introduced

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Published by marynmck
Text as introduced of GAIN (Generating Antibiotic Incentives Now) Bill, 2011
Text as introduced of GAIN (Generating Antibiotic Incentives Now) Bill, 2011

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Published by: marynmck on Jun 17, 2011
Copyright:Attribution Non-commercial

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08/01/2014

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.....................................................................(Original Signature of Member)
112
TH
CONGRESS1
ST
S
ESSION
 
H. R.
 ll 
 
To provide incentives for the development of qualified infectious diseaseproducts.
IN THE HOUSE OF REPRESENTATIVES
Mr. G
INGREY
of Georgia (for himself, Mr. G
ENE
G
REEN
of Texas, Mr. W
HITFIELD
, Ms. D
E
G
ETTE
, Mr. R
OGERS
of Michigan, Ms. E
SHOO
, andMr. S
HIMKUS
) introduced the following bill; which was referred to theCommittee on
 lllllllllllllll 
 
A BILL
 
To provide incentives for the development of qualifiedinfectious disease products.
 Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Generating Antibiotic
4
Incentives Now Act of 2011’’.
5
SEC. 2. TABLE OF CONTENTS.
6
The table of contents of this Act is as follows:
7
Sec.1.Short title.Sec.2.Table of contents.
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2
Sec.3.Extension of exclusivity period for drugs.Sec.4.Additional extension of exclusivity period for qualified infectious diseaseproducts for which a companion diagnostic test is cleared orapproved.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.
1
(a) I
N
G
ENERAL
.—The Federal Food, Drug, and
2
Cosmetic Act is amended by inserting after section 505D
3
(21 U.S.C. 355e) the following:
4
‘‘SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW
5
QUALIFIED INFECTIOUS DISEASE PRODUCTS.
6
‘‘(a) E
 XTENSION
.—If, prior to approval of a drug
7
pursuant to an application submitted under section
8
505(b), the Secretary determines that the drug is a quali-
9
fied infectious disease product, then the four- and five-
10
 year periods described in subsections (c)(3)(E)(ii) and
11
(j)(5)(F)(ii) of section 505, the three-year periods de-
12
scribed in clauses (iii) and (iv) of subsection (c)(3)(E) and
13
clauses (iii) and (iv) of subsection (j)(5)(F) of section 505,
14
or the seven year period described in section 527, as appli-
15
cable, shall be extended by five years.
16
‘‘(b) R
ELATION TO
P
EDIATRIC
E
 XCLUSIVITY
.—Any 
17
extension under subsection (a) of a period shall be in addi-
18
tion to any extension of the period under section 505A 
19
 with respect to the drug.
20
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3‘‘(c) L
IMITATIONS
.—Subsection (a) does not apply to
1
the approval of—
2
‘‘(1) a supplement to an application under sec-
3
tion 505(b) for any qualified infectious disease prod-
4
 uct for which an extension described in subsection
5
(a) is in effect or has expired; or
6
‘‘(2) a subsequent application filed by the same
7
sponsor or manufacturer of a qualified infectious
8
disease product described in paragraph (1) (or a li-
9
censor, predecessor in interest, or other related enti-
10
ty) for—
11
‘‘(A) a change (not including a modifica-
12
tion to the structure of the qualified infectious
13
disease product) that results in a new indica-
14
tion, route of administration, dosing schedule,
15
dosage form, delivery system, delivery device, or
16
strength; or
17
‘‘(B) a modification to the structure of the
18
qualified infectious disease product that does
19
not result in a change in safety or effectiveness.
20
‘‘(d) D
ETERMINATION
.—The manufacturer or spon-
21
sor of a drug may request the Secretary to designate a
22
drug as a qualified infectious disease product. Such a re-
23
quest for designation shall be made at least 45 days before
24
the submission of an application under section 505(b) for
25
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