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Accelerating the Development of New Drugs and Diagnostics Maximizing the Impact of the Cures Acceleration Network: Workshop Summary (2012) / Chapter Skim
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Appendix B: Public Health Service Act, Title IV - National Institutes of Health
Pages 87-94

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From page 87...
... BIOLOGICAL PRODUCT- The term `biological product' has the meaning given such term in section 351 of the Public Health Service Act.
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From page 88...
... ensuring that such activities are coordinated with the approval requirements of the Food and Drug Administration, with the goal of expediting the development and approval of counter measures and products; and (C) connecting interested persons with additional technical assistance made available under section 565 of the Federal Food, Drug, and Cosmetic Act.
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From page 89...
... (II) At least 4 individuals shall be recognized leaders in professional venture capital or private equity organiza tions and have demonstrated experience in private equity investing.
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From page 90...
... a representative of the National Science Foundation, recommended by the Chair of the National Science Board; and (v) a representative of the Food and Drug Administration, recommended by the Commissioner of Food and Drugs.
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From page 91...
... COMPENSATION AND TRAVEL EXPENSES (A) COMPENSATION- Members shall receive compensation at a rate to be fixed by the Chairperson but not to exceed a rate equal to the daily equivalent of the annual rate of basic pay prescribed for level IV of the Executive Schedule under section 5315 of title 5, United States Code, for each day (including travel time)
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From page 92...
... help the award recipient establish protocols that comply with Food and Drug Administration standards and otherwise per mit the recipient to meet regulatory requirements at all stages of development, manufacturing, review, approval, and safety surveil lance of a medical product.
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From page 93...
... (C) THE CURES ACCELERATION FLEXIBLE RESEARCH AWARDS- If the Director of the Center determines that the goals and objectives of this section cannot adequately be carried out through a contract, grant, or cooperative agreement, the Director of the Center shall have flexible research authority to use other trans actions to fund projects in accordance with the terms and conditions of this section.
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From page 94...
... (f) Competitive Basis of Awards- Any grant, cooperative agreement, or contract awarded under this section shall be awarded on a competitive basis.
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Key Terms

  • acceleration network
  • medical products
  • federal food
  • cosmetic act
  • biological product

  • private equity
  • flexible research
  • disease advocacy
  • funds appropriated
  • eligible entities

  • research institution
  • award grants
  • eligible entity
  • research authority
  • subsequent fiscal

  • service act
  • venture capital
  • administration standards
  • initial award
  • advocacy organization

  • professional venture
  • competitive basis
  • contracts awarded
  • review board
  • employed intermittently

  • judicial review
  • public research
  • acceleration grant
  • support revolutionary
  • pendent investigators


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