cessor system), including matching with medical assist-
ance programs operated by other States.’’. 
(b) EFFECTIVE DATE.— 
(1) IN GENERAL.—Except as provided in para-
graph (2), the amendments made by subsection (a) 
take effect on October 1, 2009. 
(2) EXTENSION
OF
EFFECTIVE
DATE
FOR 
STATE LAW AMENDMENT.—In the case of a State 
plan under title XIX of the Social Security Act (42 
U.S.C. 1396 et seq.) which the Secretary of Health 
and Human Services determines requires State legis-
lation in order for the plan to meet the additional 
requirements imposed by the amendments made by 
subsection (a), the State plan shall not be regarded 
as failing to comply with the requirements of such 
title solely on the basis of its failure to meet these 
additional requirements before the first day of the 
first calendar quarter beginning after the close of 
the first regular session of the State legislature that 
begins after the date of enactment of this Act. For 
purposes of the previous sentence, in the case of a 
State that has a 2-year legislative session, each year 
of the session is considered to be a separate regular 
session of the State legislature. 
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SEC. 4. INCENTIVES FOR THE DEVELOPMENT OF, AND AC-
CESS TO, CERTAIN ANTIBIOTICS. 
(a) IN GENERAL.—Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 
adding at the end the following: 
‘‘(v) ANTIBIOTIC DRUGS SUBMITTED BEFORE NO-
VEMBER 21, 1997.— 
‘‘(1) ANTIBIOTIC
DRUGS
APPROVED
BEFORE 
NOVEMBER 21, 1997.— 
‘‘(A) IN GENERAL.—Notwithstanding any 
provision of the Food and Drug Administration 
Modernization Act of 1997 or any other provi-
sion of law, a sponsor of a drug that is the sub-
ject of an application described in subparagraph 
(B)(i) shall be eligible for, with respect to the 
drug, the 3-year exclusivity period referred to 
under clauses (iii) and (iv) of subsection 
(c)(3)(E) and under clauses (iii) and (iv) of 
subsection (j)(5)(F), subject to the require-
ments of such clauses, as applicable. 
‘‘(B) APPLICATION; ANTIBIOTIC DRUG DE-
SCRIBED.— 
‘‘(i) APPLICATION.—An application 
described in this clause is an application 
for marketing submitted under this section 
after the date of the enactment of this sub-
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section in which the drug that is the sub-
ject of the application contains an anti-
biotic drug described in clause (ii). 
‘‘(ii) ANTIBIOTIC
DRUG.—An anti-
biotic drug described in this clause is an 
antibiotic drug that was the subject of an 
application approved by the Secretary 
under section 507 of this Act (as in effect 
before November 21, 1997). 
‘‘(2) ANTIBIOTIC DRUGS SUBMITTED BEFORE 
NOVEMBER 21, 1997, BUT NOT APPROVED.— 
‘‘(A) IN GENERAL.—Notwithstanding any 
provision of the Food and Drug Administration 
Modernization Act of 1997 or any other provi-
sion of law, a sponsor of a drug that is the sub-
ject of an application described in subparagraph 
(B)(i) may elect to be eligible for, with respect 
to the drug— 
‘‘(i)(I) the 3-year exclusivity period re-
ferred to under clauses (iii) and (iv) of 
subsection (c)(3)(E) and under clauses (iii) 
and (iv) of subsection (j)(5)(F), subject to 
the requirements of such clauses, as appli-
cable; and 
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‘‘(II) the 5-year exclusivity period re-
ferred to under clause (ii) of subsection 
(c)(3)(E) and under clause (ii) of sub-
section (j)(5)(F), subject to the require-
ments of such clauses, as applicable; or 
‘‘(ii) a patent term extension under 
section 156 of title 35, United States 
Code, subject to the requirements of such 
section. 
‘‘(B) APPLICATION; ANTIBIOTIC DRUG DE-
SCRIBED.— 
‘‘(i) APPLICATION.—An application 
described in this clause is an application 
for marketing submitted under this section 
after the date of the enactment of this sub-
section in which the drug that is the sub-
ject of the application contains an anti-
biotic drug described in clause (ii). 
‘‘(ii) ANTIBIOTIC
DRUG.—An anti-
biotic drug described in this clause is an 
antibiotic drug that was the subject of 1 or 
more applications received by the Secretary 
under section 507 of this Act (as in effect 
before November 21, 1997), none of which 
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was approved by the Secretary under such 
section. 
‘‘(3) LIMITATIONS.— 
‘‘(A) EXCLUSIVITIES AND EXTENSIONS.— 
Paragraphs (1)(A) and (2)(A) shall not be con-
strued to entitle a drug that is the subject of 
an approved application described in subpara-
graphs (1)(B)(i) or (2)(B)(i), as applicable, to 
any market exclusivities or patent extensions 
other than those exclusivities or extensions de-
scribed in paragraph (1)(A) or (2)(A). 
‘‘(B) CONDITIONS
OF
USE.—Paragraphs 
(1)(A) and (2)(A)(i) shall not apply to any con-
dition of use for which the drug referred to in 
subparagraph (1)(B)(i) or (2)(B)(i), as applica-
ble, was approved before the date of the enact-
ment of this subsection. 
‘‘(4) APPLICATION OF CERTAIN PROVISIONS.— 
Notwithstanding section 125, or any other provision, 
of the Food and Drug Administration Modernization 
Act of 1997, or any other provision of law, and sub-
ject to the limitations in paragraphs (1), (2), and 
(3), the provisions of the Drug Price Competition 
and Patent Term Restoration Act of 1984 shall 
apply to any drug subject to paragraph (1) or any 
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drug with respect to which an election is made under 
paragraph (2)(A).’’. 
(b) TRANSITIONAL RULES.— 
(1) With respect to a patent issued on or before 
the date of the enactment of this Act, any patent in-
formation required to be filed with the Secretary of 
Health and Human Services under subsection (b)(1) 
or (c)(2) of section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355) to be listed on a 
drug to which subsection (v)(1) of such section 505 
(as added by this section) applies shall be filed with 
the Secretary not later than 60 days after the date 
of the enactment of this Act. 
(2) With respect to any patent information re-
ferred to in paragraph (1) of this subsection that is 
filed with the Secretary within the 60-day period 
after the date of the enactment of this Act, the Sec-
retary shall publish such information in the elec-
tronic version of the list referred to at section 
505(j)(7) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(7)) as soon as it is received, 
but in no event later than the date that is 90 days 
after the enactment of this Act. 
(3) With respect to any patent information re-
ferred to in paragraph (1) that is filed with the Sec-
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retary within the 60-day period after the date of en-
actment of this Act, each applicant that, not later 
than 120 days after the date of the enactment of 
this Act, amends an application that is, on or before 
the date of the enactment of this Act, a substantially 
complete application (as defined in paragraph 
(5)(B)(iv) of section 505(j) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j))) to con-
tain 
a 
certification 
described 
in 
paragraph 
(2)(A)(vii)(IV) of such section 505(j) with respect to 
that patent shall be deemed to be a first applicant 
(as defined in paragraph (5)(B)(iv) of such section 
505(j)). 
SEC. 5. CLARIFICATION OF AUTHORITY FOR USE OF MED-
ICAID INTEGRITY PROGRAM FUNDS. 
(a) CLARIFICATION
OF AUTHORITY
FOR USE
OF 
FUNDS.— 
(1) IN GENERAL.—Section 1936 of the Social 
Security Act (42 U.S.C. 1396u–6) is amended— 
(A) in subsection (b)(4), by striking ‘‘Edu-
cation of’’ and inserting ‘‘Education or training, 
including at such national, State, or regional 
conferences as the Secretary may establish, of 
State or local officers, employees, or inde-
pendent contractors responsible for the adminis-
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tration or the supervision of the administration 
of the State plan under this title,’’; and 
(B) in subsection (e), by striking para-
graph (2) and inserting the following: 
‘‘(2) AVAILABILITY; AUTHORITY FOR USE OF 
FUNDS.— 
‘‘(A) 
AVAILABILITY.—Amounts 
appro-
priated pursuant to paragraph (1) shall remain 
available until expended. 
‘‘(B) AUTHORITY FOR USE OF FUNDS FOR 
TRANSPORTATION AND TRAVEL EXPENSES FOR 
ATTENDEES AT EDUCATION, TRAINING, OR CON-
SULTATIVE ACTIVITIES.— 
‘‘(i) IN
GENERAL.—The Secretary 
may use amounts appropriated pursuant to 
paragraph (1) to pay for transportation 
and the travel expenses, including per diem 
in lieu of subsistence, at rates authorized 
for employees of agencies under subchapter 
I of chapter 57 of title 5, United States 
Code, while away from their homes or reg-
ular places of business, of individuals de-
scribed in subsection (b)(4) who attend 
education, training, or consultative activi-
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ties conducted under the authority of that 
subsection.’’. 
(2) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall take effect as if included in 
the enactment of section 1936 of the Social Security 
Act, as added by section 6034(a) of the Deficit Re-
duction Act of 2005 (Public Law 109–171). 
(b) PUBLIC DISCLOSURE.— 
(1) IN
GENERAL.—Section 1936(e)(2)(B) of 
such Act (42 U.S.C. 1396u–6(e)(2)(B)), as added by 
subsection (a) of this section, is amended by adding 
at the end the following: 
‘‘(ii) PUBLIC DISCLOSURE.—The Sec-
retary shall make available on a website of 
the Centers for Medicare & Medicaid Serv-
ices that is accessible to the public— 
‘‘(I) the total amount of funds 
expended for each conference con-
ducted under the authority of sub-
section (b)(4); and 
‘‘(II) the amount of funds ex-
pended for each such conference that 
were for transportation and for travel 
expenses.’’. 
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(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall apply to conferences con-
ducted under the authority of section 1936(b)(4) of 
the Social Security Act (42 U.S.C. 1396u–6(b)(4)) 
after the date of enactment of this Act. 
SEC. 6. FUNDING FOR THE MEDICARE IMPROVEMENT 
FUND. 
Section 1898(b)(1) of the Social Security Act (42 
U.S.C. 
1395iii(b)(1)) 
is 
amended 
by 
striking 
‘‘$2,220,000,000’’ and inserting ‘‘$2,290,000,000’’. 
SEC. 7. TECHNICAL CORRECTION. 
Section 1941(b)(1)(B) of the Social Security Act, as 
added by section 7002(b) of the Supplemental Appropria-
tions Act, 2008, is amended by inserting ‘‘each of’’ after 
‘‘for’’. 
Æ 
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