121 STAT. 972
PUBLIC LAW 110–85—SEPT. 27, 2007
written policies to implement this section and govern the timely submission, review, clearance, and disclaimer requirements for articles. ‘‘(c) TIMING OF SUBMISSION FOR REVIEW.—If an officer or employee, including a Staff Fellow and a contractor who performs staff work, of the Food and Drug Administration is directed by the policies established under subsection (b) to submit an article to the supervisor of such officer or employee, or to some other official of the Food and Drug Administration, for review and clearance before such officer or employee may seek to publish or present such an article at a conference, such officer or employee shall submit such article for such review and clearance not less than 30 days before submitting the article for publication or presentation. ‘‘(d) TIMING FOR REVIEW AND CLEARANCE.—The supervisor or other reviewing official shall review such article and provide written clearance, or written clearance on the condition of specified changes being made, to such officer or employee not later than 30 days after such officer or employee submitted such article for review. ‘‘(e) NON-TIMELY REVIEW.—If, 31 days after such submission under subsection (c), the supervisor or other reviewing official has not cleared or has not reviewed such article and provided written clearance, such officer or employee may consider such article not to have been cleared and may submit the article for publication or presentation with an appropriate disclaimer as specified in the policies established under subsection (b). ‘‘(f) EFFECT.—Nothing in this section shall be construed as affecting any restrictions on such publication or presentation provided by other provisions of law.’’. SEC. 1102. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL DISEASES.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the following: 21 USC 360n.
‘‘SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL DISEASES.
dkrause on GSDDPC44 with PUBLAW
‘‘(a) DEFINITIONS.—In this section: ‘‘(1) PRIORITY REVIEW.—The term ‘priority review’, with respect to a human drug application as defined in section 735(1), means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007. ‘‘(2) PRIORITY REVIEW VOUCHER.—The term ‘priority review voucher’ means a voucher issued by the Secretary to the sponsor of a tropical disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 505(b)(1) or section 351 of the Public Health Service Act after the date of approval of the tropical disease product application. ‘‘(3) TROPICAL DISEASE.—The term ‘tropical disease’ means any of the following: ‘‘(A) Tuberculosis. ‘‘(B) Malaria. ‘‘(C) Blinding trachoma.
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