PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 899
dkrause on GSDDPC44 with PUBLAW
‘‘(A) an institution of higher education (as such term is defined in section 101 of the Higher Education Act of 1965) or a consortium of such institutions; or ‘‘(B) an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from tax under section 501(a) of such Code. ‘‘(2) The entity has experienced personnel and clinical and other technical expertise in the biomedical sciences, which may include graduate training programs in areas relevant to priorities of the Critical Path Initiative. ‘‘(3) The entity demonstrates to the Secretary’s satisfaction that the entity is capable of— ‘‘(A) developing and critically evaluating tools, methods, and processes— ‘‘(i) to increase efficiency, predictability, and productivity of medical product development; and ‘‘(ii) to more accurately identify the benefits and risks of new and existing medical products; ‘‘(B) establishing partnerships, consortia, and collaborations with health care practitioners and other providers of health care goods or services; pharmacists; pharmacy benefit managers and purchasers; health maintenance organizations and other managed health care organizations; health care insurers; government agencies; patients and consumers; manufacturers of prescription drugs, biological products, diagnostic technologies, and devices; and academic scientists; and ‘‘(C) securing funding for the projects of a Critical Path Public-Private Partnership from Federal and nonfederal governmental sources, foundations, and private individuals. ‘‘(c) FUNDING.—The Secretary may not enter into a collaborative agreement under subsection (a) unless the eligible entity involved provides an assurance that the entity will not accept funding for a Critical Path Public-Private Partnership project from any organization that manufactures or distributes products regulated by the Food and Drug Administration unless the entity provides assurances in its agreement with the Food and Drug Administration that the results of the Critical Path Public-Private Partnership project will not be influenced by any source of funding. ‘‘(d) ANNUAL REPORT.—Not later than 18 months after the date of the enactment of this section, and annually thereafter, the Secretary, in collaboration with the parties to each Critical Path Public-Private Partnership, shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives— ‘‘(1) reviewing the operations and activities of the Partnerships in the previous year; and ‘‘(2) addressing such other issues relating to this section as the Secretary determines to be appropriate. ‘‘(e) DEFINITION.—In this section, the term ‘medical product’ includes a drug, a biological product as defined in section 351 of the Public Health Service Act, a device, and any combination of such products. ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $5,000,000 for fiscal
VerDate Aug 31 2005
13:52 Jan 23, 2009
Jkt 059194
PO 00001
Frm 00897
Fmt 6580
Sfmt 6581
M:\STATUTES\2007\59194PT1.001
APPS10
PsN: 59194PT1
�
