I 
112TH CONGRESS 
2D SESSION 
H. R. 4332 
To amend section 505(j) of the Federal Food, Drug, and Cosmetic Act 
to extend the period for a first applicant, with respect to a generic 
drug, to obtain tentative approval without forfeiting the 180-day exclu-
sivity period, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 29, 2012 
Mr. PALLONE (for himself and Mr. GUTHRIE) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend section 505(j) of the Federal Food, Drug, and 
Cosmetic Act to extend the period for a first applicant, 
with respect to a generic drug, to obtain tentative ap-
proval without forfeiting the 180-day exclusivity period, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Generic Drug Applica-
tion Review Fairness Act of 2012’’. 
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SEC. 2. 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) of the Federal Food, Drug, and Cos-
metic Act (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-
cant fails to obtain tentative approval 
of the application within 60 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.— 
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(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 
(ii) only if no certification under para-
graph (2)(A)(vii)(IV) of such section 
505(j) was made before such day with re-
spect to the listed drug (as such term is 
used in such section 505(j)). 
(B) CERTAIN APPLICATIONS.—If an appli-
cation was filed under section 505(j) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) prior to the day specified in sub-
paragraph (A)(i) and, on such day, contained a 
certification 
described 
in 
paragraph 
(2)(A)(vii)(IV), the application shall be subject 
to paragraph (5)(D)(i)(IV) of such section 
505(j) as in effect on the day before the date 
of the enactment of this Act. 
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(b) INCREMENTAL REDUCTION OF EXTENDED PE-
RIOD.— 
(1) PERIOD DURATION.— 
(A) Effective on October 1, 2013, sub-
clause (IV) of section 505(j)(5)(D)(i) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)(D)(i)), as amended by sub-
section (a)(1), is amended by striking ‘‘60 
months’’ and inserting ‘‘54 months’’. 
(B) Effective on October 1, 2014, sub-
clause (IV) of section 505(j)(5)(D)(i) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)(D)(i)), as amended by sub-
paragraph (A), is amended by striking ‘‘54 
months’’ and inserting ‘‘48 months’’. 
(C) Effective on October 1, 2015, sub-
clause (IV) of section 505(j)(5)(D)(i) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)(D)(i)), as amended by sub-
paragraph (B), is amended by striking ‘‘48 
months’’ and inserting ‘‘42 months’’. 
(D) Effective on October 1, 2016, sub-
clause (IV) of section 505(j)(5)(D)(i) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)(D)(i)), as amended by sub-
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paragraph (C), is amended by striking ‘‘42 
months’’ and inserting ‘‘36 months’’. 
(E) Effective on October 1, 2017, sub-
clause (IV) of section 505(j)(5)(D)(i) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)(D)(i)), as amended by sub-
paragraph (D), is amended by striking ‘‘36 
months’’ and inserting ‘‘30 months’’. 
(2) APPLICABILITY.— 
(A) The amendments made by subpara-
graphs (A), (B), (C), and (D) of paragraph (1) 
apply only with respect to an application under 
section 505(j) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)) that— 
(i) is filed and initially contains a cer-
tification 
described 
in 
paragraph 
(2)(A)(vii)(IV) during the period of one 
fiscal year beginning on the effective date 
of the respective amendment; or 
(ii) is amended to initially contain 
such a certification during such period. 
(B) The amendment made by paragraph 
(1)(E) applies only with respect to an applica-
tion under section 505(j) of the Federal Food, 
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Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
that— 
(i) is filed and initially contains a cer-
tification 
described 
in 
paragraph 
(2)(A)(vii)(IV) on or after October 1, 
2017; or 
(ii) is amended to initially contain 
such a certification on or after October 1, 
2017. 
(c) CONFORMING AMENDMENT.—Subparagraph (G) 
of section 505(q)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(q)(1)) is amended by striking 
‘‘the 30-month period’’ and inserting ‘‘the period’’. 
SEC. 3. MAINTENANCE OF OFFICE OF GENERIC DRUGS AT 
CDER; REPORTING. 
Section 505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)) is amended by adding at the 
end the following: 
‘‘(11) OFFICE OF GENERIC DRUGS.— 
‘‘(A) OFFICE.—The Secretary shall main-
tain the Office of Generic Drugs as a separate 
office within the Center for Drug Evaluation 
and Research of the Food and Drug Adminis-
tration. 
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‘‘(B) REPORTING.—The Director of the 
Office of Generic Drugs shall report directly to 
the Director of the Center for Drug Evaluation 
and Research.’’. 
Æ 
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