Sec. 1135. FINAL AGENCY ACTION RELATING TO PETITIONS AND CIVIL ACTIONS

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## SEC. 1135 FINAL AGENCY ACTION RELATING TO PETITIONS AND CIVIL ACTIONS Section 505(q) (21 U.S.C. 355(q)) is amended— ####

(1)in paragraph (1)— #####

(A)in subparagraph (A), by striking “subsection (b)(2) or (j)” and inserting “subsection (b)(2) or

(j)of this section or section 351(k) of the Public Health Service Act”; and #####

(B)in subparagraph (F), by striking “180 days” and inserting “150 days”; ####

(2)in paragraph (2)(A)— #####

(A)in the subparagraph heading, by striking “180” and inserting “150”; and #####

(B)in clause (i), by striking “180-day” and inserting “150-day”; ####

(3)in paragraph (4)— #####

(A)by redesignating subparagraphs

(A)and

(B)as clauses

(i)and (ii), respectively, and moving such clauses, as so redesignated, 2 ems to the right; #####

(B)by striking “ This subsection does not apply to— ” and inserting the following: > > ##### “(A) > > This subsection does not apply to—” > ; and #####

(C)by adding at the end the following: > > ##### “(B) > > Paragraph

(2)does not apply to a petition addressing issues concerning an application submitted pursuant to section 351(k) of the Public Health Service Act.” > ; and ####

(4)in paragraph (5), by striking “subsection (b)(2) or (j)” inserting “subsection (b)(2) or

(j)of the Act or 351(k) of the Public Health Service Act”.

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U.S. Code

New drugs
§ 355

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Sec. 1135

FINAL AGENCY ACTION RELATING TO PETITIONS AND CIVIL ACTIONS

U.S.C.§ 355

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