121 STAT. 898
PUBLIC LAW 110–85—SEPT. 27, 2007
SEC. 602. OFFICE OF THE CHIEF SCIENTIST.
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following: 21 USC 399a.
‘‘SEC. 910. OFFICE OF THE CHIEF SCIENTIST.
‘‘(a) ESTABLISHMENT; APPOINTMENT.—The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office. ‘‘(b) DUTIES OF THE OFFICE.—The Office of the Chief Scientist shall— ‘‘(1) oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration; ‘‘(2) track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration; ‘‘(3) develop and advocate for a budget to support intramural research; ‘‘(4) develop a peer review process by which intramural research can be evaluated; ‘‘(5) identify and solicit intramural research proposals from across the Food and Drug Administration through an advisory board composed of employees of the Administration that shall include— ‘‘(A) representatives of each of the centers and the science-based offices within the Office of the Commissioner; and ‘‘(B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and ‘‘(6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.’’. SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the following:
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21 USC 360bbb–5.
VerDate Aug 31 2005
13:52 Jan 23, 2009
‘‘SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
‘‘(a) ESTABLISHMENT.—The Secretary, acting through the Commissioner of Food and Drugs, may enter into collaborative agreements, to be known as Critical Path Public-Private Partnerships, with one or more eligible entities to implement the Critical Path Initiative of the Food and Drug Administration by developing innovative, collaborative projects in research, education, and outreach for the purpose of fostering medical product innovation, enabling the acceleration of medical product development, manufacturing, and translational therapeutics, and enhancing medical product safety. ‘‘(b) ELIGIBLE ENTITY.—In this section, the term ‘eligible entity’ means an entity that meets each of the following: ‘‘(1) The entity is—
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