Page:United States Statutes at Large Volume 120.djvu/2905

 120 STAT. 2874

PUBLIC LAW 109–417—DEC. 19, 2006

‘‘(2) identify accepted animal models for particular diseases and conditions associated with any biological, chemical, radiological, or nuclear agent, any toxin, or any potential pandemic infectious disease, and identify strategies to accelerate animal model and research tool development and validation; and ‘‘(3) obtain advice regarding supporting and facilitating advanced research and development related to qualified countermeasures and qualified pandemic or epidemic products that are likely to be safe and effective with respect to children, pregnant women, and other vulnerable populations, and other issues regarding activities under this section that affect such populations. ‘‘(c) DEFINITIONS.—Any term that is defined in section 319L and that is used in this section shall have the same meaning in this section as such term is given in section 319L. ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated $1,000,000 to carry out this section for fiscal year 2007 and each fiscal year thereafter.’’. SEC. 403. CLARIFICATION OF COUNTERMEASURES COVERED BY PROJECT BIOSHIELD.

42 USC 247d–6b.

42 USC 321j.

VerDate 14-DEC-2004

09:16 Jul 13, 2007

(a) QUALIFIED COUNTERMEASURE.—Section 319F–1(a) of the Public Health Service Act (42 U.S.C. 247d–6a(a)) is amended by striking paragraph (2) and inserting the following: ‘‘(2) DEFINITIONS.—In this section: ‘‘(A) QUALIFIED COUNTERMEASURE.—The term ‘qualified countermeasure’ means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that the Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of the Homeland Security Act of 2002) to— ‘‘(i) diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security; or ‘‘(ii) diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in this subparagraph. ‘‘(B) INFECTIOUS DISEASE.—The term ‘infectious disease’ means a disease potentially caused by a pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a person and that reproduces in that person.’’. (b) SECURITY COUNTERMEASURE.—Section 319F–2(c)(1)(B) is amended by striking ‘‘treat, identify, or prevent’’ each place it appears and inserting ‘‘diagnose, mitigate, prevent, or treat’’. (c) LIMITATION ON USE OF FUNDS.—Section 510(a) of the Homeland Security Act of 2002 (6 U.S.C. 320(a)) is amended by adding at the end the following: ‘‘None of the funds made available under this subsection shall be used to procure countermeasures to

Jkt 059194

PO 00003

Frm 00353

Fmt 6580

Sfmt 6581

E:\PUBLAW\PUBL003.109

APPS06

PsN: PUBL003

�