Page:United States Statutes at Large Volume 121.djvu/846

 PUBLIC LAW 110–85—SEPT. 27, 2007 Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec.

1002. 1003. 1004. 1005. 1006. 1007. 1008. 1009. 1010. 1011.

121 STAT. 825

Ensuring the safety of pet food. Ensuring efficient and effective communications during a recall. State and Federal Cooperation. Reportable Food Registry. Enhanced aquaculture and seafood inspection. Consultation regarding genetically engineered seafood products. Sense of Congress. Annual report to Congress. Publication of annual reports. Rule of construction. TITLE XI—OTHER PROVISIONS Subtitle A—In General

Sec. 1101. Policy on the review and clearance of scientific articles published by FDA employees. Sec. 1102. Priority review to encourage treatments for tropical diseases. Sec. 1103. Improving genetic test safety and quality. Sec. 1104. NIH Technical amendments. Sec. 1105. Severability clause. Subtitle B—Antibiotic Access and Innovation Sec. Sec. Sec. Sec.

1111. 1112. 1113. 1114.

Identification of clinically susceptible concentrations of antimicrobials. Orphan antibiotic drugs. Exclusivity of certain drugs containing single enantiomers. Report.

TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

Prescription Drug User Fee Amendments of 2007.

SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.

(a) SHORT TITLE.—This title may be cited as the ‘‘Prescription Drug User Fee Amendments of 2007’’. (b) REFERENCES IN TITLE.—Except as otherwise specified, amendments made by this title to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (c) FINDING.—The Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

21 USC 301 note.

21 USC 379g note.

SEC. 102. DEFINITIONS.

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Section 735 (21 U.S.C. 379g) is amended— (1) in the matter before paragraph (1), by striking ‘‘For purposes of this subchapter’’ and inserting ‘‘For purposes of this part’’; (2) in paragraph (1)— (A) in subparagraph (A), by striking ‘‘505(b)(1),’’ and inserting ‘‘505(b), or’’; (B) by striking subparagraph (B); (C) by redesignating subparagraph (C) as subparagraph (B); and

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