II 

109TH CONGRESS 

1ST SESSION S. 975 

To provide incentives to increase research by private sector entities to develop 

medical countermeasures to prevent, detect, identify, contain, and treat 

illnesses, including those associated with a biological, chemical, nuclear, 

or radiological weapons attack or an infectious disease outbreak, and 

for other purposes. 

IN THE SENATE OF THE UNITED STATES 

APRIL 29 (legislative day, APRIL 28), 2005 

Mr. LIEBERMAN (for himself, Mr. HATCH, and Mr. BROWNBACK) introduced 

the following bill; which was read the first time 

A BILL 

To provide incentives to increase research by private sector 

entities to develop medical countermeasures to prevent, 

detect, identify, contain, and treat illnesses, including 

those associated with a biological, chemical, nuclear, or 

radiological weapons attack or an infectious disease outbreak, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Project BioShield II Act of 2005’’. 
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1 (b) IN HONOR.—This Act is enacted in honor of Rob2 ert Stevens, Thomas Morris, Jr., Joseph Curseen, Kathy 

3 Nguyen, Ottilie Lundgren, and Lisa J. Raines, victims of 

4 terrorist attacks in the United States in 2001. 

5 (c) TABLE OF CONTENTS.—The table of contents of 

6 this Act is as follows: 

Sec. 1. Short title. 

TITLE I—AMENDMENTS TO THE PROJECT BIOSHIELD ACT OF 

2004 REGARDING TERROR COUNTERMEASURES 

Sec. 101. Procurement of certain drugs, detection technology, diagnostics, and 

research tools. 

Sec. 102. Additional authority under project bioshield. 

Sec. 103. Request of agency. 

TITLE II—AMENDMENTS TO THE PROJECT BIOSHIELD ACT OF 

2004 REGARDING INFECTIOUS DISEASE COUNTERMEASURES; 

ADDITIONAL PROVISIONS 

Sec. 201. Amendments to the Project Bioshield Act of 2004 regarding infectious disease countermeasures. 

Sec. 202. Procurement pools; additional incentives under Project Bioshield. 

Sec. 203. Annual report. 

Sec. 204. Use of funds; requirements of manufacturers. 

TITLE III—AMENDMENTS TO THE PROJECT BIOSHIELD ACT OF 

2004 REGARDING INCENTIVES TO ESTABLISH BIODEFENSE, INFECTIOUS DISEASE, VACCINE, AND RESEARCH TOOL INDUSTRIES. 

Subtitle A—Certification of Successful Development 

Sec. 301. Certification of successful development. 

Subtitle B—Federal Tax Incentives 

Sec. 311. General provisions. 

Sec. 312. Tax credits. 

Subtitle C—Patent Protections 

Sec. 331. Patent term restoration and extension and exclusive marketing. 

Sec. 332. International protection for bioshield intellectual property. 

Subtitle D—Liability Protections 

Sec. 341. Liability and compensation for injured parties. 

TITLE IV—VALLEY OF DEATH FOR SMALL COMPANIES 

Sec. 401. Purpose. 
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Sec. 402. Valley of death for small companies. 

TITLE V—BIOSHIELD ANTITRUST EXEMPTION 

Sec. 501. Limited antitrust exemption. 

TITLE VI—BIOSHIELD IMMIGRATION PRIORITY 

Sec. 601. H1B visa exemption. 

Sec. 602. Visa processing. 

TITLE VII—BIOSHIELD EXPORT PRIORITY 

Sec. 701. Short title. 

Sec. 702. Requirement to expedite export applications. 

Sec. 703. Preservation of foreign sales markets for qualified and security countermeasures. 

TITLE VIII—OFFICE OF PUBLIC HEALTH COUNTERMEASURE 

DEVELOPMENT 

Sec. 801. Office of Public Health Countermeasure Development. 

Sec. 802. Bioterror, chemical, nuclear, radiological, and infectious disease countermeasure development strategy. 

TITLE IX—OFFICE OF MEDICAL READINESS AND RESPONSE OF 

THE DEPARTMENT OF HOMELAND SECURITY 

Sec. 901. Office of Medical Readiness and Response of the Department of 

Homeland Security. 

TITLE X—NATIONAL EMERGENCY MEDICAL READINESS AND 

RESPONSE BOARD 

Sec. 1001. National Emergency Medical Readiness and Response Board. 

TITLE XI—ENCOURAGING GREATER COORDINATION WITH 

FORMER SOVIET SCIENTISTS AND TRANSFER OF COUNTERMEASURES 

Sec. 1101. Purpose; report to Congress. 

TITLE XII—EMERGENCY CONTINUITY OF NATIONAL 

HEALTHCARE; REIMBURSEMENT OF INFECTIOUS DISEASE 

PHYSICIANS FOR COMMUNITY EMERGENCY PREPAREDNESS ACTIVITIES; MEDICAL LICENSE RECIPROCITY 

Sec. 1201. Continuity of national healthcare system in an emergency. 

Sec. 1202. Reimbursement of infectious disease physicians for community emergency preparedness activities. 

Sec. 1203. Medical license reciprocity. 

Sec. 1204. Liability protection for healthcare volunteers and hospitals. 

TITLE XIII—ADEQUACY OF EMERGENCY MEDICAL RESPONSE 

ASSETS FOR HOMELAND SECURITY MISSIONS 

Sec. 1301. Adequacy of emergency medical response assets for homeland security missions. 
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TITLE XIV—CONSTRUCTION OF SPECIALIZED RESEARCH 

FACILITIES FOR THE DEVELOPMENT OF COUNTERMEASURES 

Sec. 1401. Construction of specialized research facilities for the development of 

countermeasures. 

TITLE XV—BIODEFENSE AND INFECTIOUS DISEASE RESEARCH 

AND SCIENTIFIC AND TECHNICAL PERSONNEL 

Sec. 1501. Establishment of grant program. 

TITLE XVI—NATIONAL INSTITUTES OF HEALTH 

Subtitle A—National Center for Healthcare Technology Development 

Sec. 1601. Purpose. 

Sec. 1602. National Center for Healthcare Technology Development. 

Sec. 1603. Technology development opportunities assessments. 

Sec. 1604. Resources for the National Center for Healthcare Technology Development. 

Sec. 1605. Biennial report of the Director of the National Institutes of Health 

to the President and Congress. 

Sec. 1606. Authority of the Directors of the National Research Institutes; biennial report. 

Sec. 1607. Commercial research and investigations. 

Sec. 1608. SBIR/STTR program consultation with the Director of the Center 

of Healthcare Technology Development. 

Sec. 1609. Purpose of the National Research Institutes. 

Sec. 1610. Conforming amendment. 

Sec. 1611. Effective date. 

Subtitle B—Protecting Government Investment in Basic Biomedical Research 

Sec. 1621. Findings. 

Sec. 1622. Utilization and availability. 

Sec. 1623. Restoration of term of unexploited patents on Government sponsored inventions relating to countermeasures. 

Sec. 1624. Encouraging the patenting of research tools. 

Sec. 1625. Effective date. 

Subtitle C—Partnership Challenge Grants 

Sec. 1631. Partnership challenge grants. 

TITLE XVII—DEVELOPMENT OF COUNTERMEASURE RESEARCH 

AT THE DEPARTMENT OF DEFENSE 

Sec. 1701. Development of countermeasure research at the Department of Defense. 

Sec. 1702. Request by the department of defense. 

Sec. 1703. Expanded public-private partnership agreements for research and 

development. 

TITLE XVIII—MILLENNIUM MEDICINE DISCOVERY AWARD 

Sec. 1801. Millennium Medicine Discovery Award. 

TITLE XIX—FOOD AND DRUG ADMINISTRATION 
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Sec. 1901. Other incentives. 

Sec. 1902. Systems biology. 

Sec. 1903. Bioterror and infectious disease provisions. 

Sec. 1904. Approvals of certain drugs based on animal trials. 

Sec. 1905. Clinical trial guidelines for anti-infectives. 

Sec. 1906. Authorization of appropriations for FDA purchase of microbiological 

data. 

Sec. 1907. Authorization of appropriations to implement Public Health Service 

action plan to combat antimicrobial resistance. 

TITLE XX—ANIMAL MODELS 

Sec. 2001. Animal models for certain diseases. 

Sec. 2002. Animal models five-year initiative. 

TITLE XXI—STRENGTHENING OF THE VACCINE INDUSTRY 

Subtitle A—Biologics, Adjuvants, and Cell Culture Development 

Sec. 2101. Biologics manufacturing capacity incentives. 

Sec. 2102. Biologics manufacturing efficiency incentives. 

Sec. 2103. Development of vaccine adjuvants. 

Sec. 2104. Cell culture or recombinant vaccines. 

Subtitle B—Influenza Vaccine 

CHAPTER 1—INFLUENZA VACCINE AWARENESS CAMPAIGN

Sec. 2111. Awareness campaign and education and outreach efforts. 

CHAPTER 2—ENCOURAGING VACCINE PRODUCTION CAPACITY

Sec. 2121. Incentives for the construction of vaccine manufacturing facilities. 

CHAPTER 3—ENSURING SUFFICIENT FLU VACCINE SUPPLY

Sec. 2131. Vaccine supply. 

CHAPTER 4—PREPARING FOR A PANDEMIC OR EPIDEMIC

Sec. 2141. Preparation for influenza pandemic or epidemic; anti-virals supply. 

CHAPTER 5—REPORT AND ADMINISTRATION

Sec. 2151. Report to Congress. 

Sec. 2152. Simplified administration of vaccine supply. 

Sec. 2153. Medicare coverage of vaccines and prophylaxis as countermeasures. 

TITLE XXII—GAAP ACCOUNTING FOR VACCINE REVENUE 

RECOGNITION 

Sec. 2201. GAAP accounting for vaccine procurement. 

TITLE XXIII—HUMAN CLINICAL TRIALS AND DRUGS FOR RARE 

DISEASES AND CONDITIONS 
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Sec. 2301. Expanded human clinical trials qualifying for orphan drug credit. 

TITLE XXIV—HEALTHCARE SYSTEM COLLECTION OF CLINICAL 

DATA REGARDING SAFETY AND EFFECTIVENESS OF COUNTERMEASURES 

Sec. 2401. Findings; definitions. 

Sec. 2402. Certification of clinical countermeasures delivery centers. 

Sec. 2403. Eligibility criteria. 

Sec. 2404. Policies, procedures, and protocols for the delivery of clinical countermeasures. 

Sec. 2405. Incentives for qualified clinical countermeasures delivery centers. 

Sec. 2406. Authorization of appropriations. 

TITLE XXV—CENTERS FOR DISEASE CONTROL AND PREVENTION 

Sec. 2501. Global Disease Detection Trust Fund. 

Sec. 2502. Environmental microbiology facility study and report. 

Sec. 2503. Enforcement of quarantines. 

Sec. 2504. Educational campaign at the Centers for Disease Control and Prevention. 

TITLE XXVI—ZOONOTIC DISEASE SURVEILLANCE 

Sec. 2601. Zoonotic disease surveillance. 

TITLE XXVII—COUNTERMEASURES AGAINST AGROTERRORISM 

Sec. 2701. Findings. 

Sec. 2702. Definitions. 

Sec. 2703. Establishment of working group. 

Sec. 2704. Duties. 

Sec. 2705. State and local assistance. 

Sec. 2706. Interagency coordination. 

Sec. 2707. Regional, State, and local preparedness. 

Sec. 2708. International activities. 

Sec. 2709. Review of legal authority. 

TITLE XXVIII—GLOBAL DISTRIBUTION OF MEDICAL 

COUNTERMEASURES. 

Sec. 2801. Findings. 

Sec. 2802. Report by USAID. 

TITLE XXIX—ENVIRONMENTAL PROTECTION AGENCY; 

DECONTAMINATION AND REMEDIATION 

Sec. 2901. Findings. 

Sec. 2902. Report on capabilities. 
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1 TITLE I—AMENDMENTS TO THE 

2 PROJECT BIOSHIELD ACT OF 

3 2004 REGARDING TERROR 

4 COUNTERMEASURES 

5 SEC. 101. PROCUREMENT OF CERTAIN DRUGS, DETECTION 

6 TECHNOLOGY, DIAGNOSTICS, AND RESEARCH 

7 TOOLS. 

8 (a) IN GENERAL.—Part B of title III of the Public 

9 Health Service Act (42 U.S.C. 243 et seq.) is amended— 

10 (1) in section 319F–1(a)— 

11 (A) by redesignating paragraphs (3), (4), 

12 and (5) as paragraphs (4), (5), and (6), respec13 tively; and 

14 (B) by inserting after paragraph (2) the 

15 following: 

16 ‘‘(3) INCLUSION.—The term ‘qualified counter17 measure’ includes detection technology, diagnostics, 

18 and research tools, as those terms are defined in sec19 tion 319F–3.’’; and 

20 (2) in section 319F–2(c)(1)(B), in the matter 

21 preceding clause (i), by striking ‘‘means a’’ and in22 serting ‘‘means detection technology, diagnostics, 

23 and research tools, as those terms are defined in 

24 319F–3, a’’. 
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1 (b) PURCHASE FUNDS.—Title V of the Homeland Se2 curity Act of 2002 (6 U.S.C. 311 et seq.) is amended by 

3 adding at the end the following: 

4 ‘‘SEC. 512. COUNTERMEASURE PURCHASE FUND AT THE 

5 DEPARTMENT OF HOMELAND SECURITY. 

6 ‘‘(a) PURCHASE FUND.— 

7 ‘‘(1) ESTABLISHMENT OF FUND.—There is es8 tablished in the Department a fund to be known as 

9 the ‘Terrorism and Infectious Disease Counter10 measure Purchase Fund’ (referred to in this sub11 section as the ‘Fund’) consisting of amounts appro12 priated for expenditure by the Secretary under para13 graph (4). This fund shall be separate from the spe14 cial reserve fund established under section 510. 

15 ‘‘(2) INVESTMENT OF FUND.—Amounts in the 

16 Fund shall be invested in accordance with section 

17 9702 of title 31, United States Code, and any inter18 est on, and proceeds from, any such investment shall 

19 be credited to and become part of the Fund. 

20 ‘‘(3) USE OF FUND.— 

21 ‘‘(A) IN GENERAL.—The Secretary shall 

22 expend amounts in the Fund— 

23 ‘‘(i) for the purchase of counter24 measures; and 
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1 ‘‘(ii) to provide advance, partial, 

2 progress or other payments, in accordance 

3 with subparagraph (E), to manufacturers 

4 of countermeasures. 

5 ‘‘(B) PURCHASE.—Countermeasures shall 

6 be purchased by the Fund at the price and 

7 under the terms negotiated by the Secretary 

8 and the manufacturer or at a commercial price, 

9 if applicable. 

10 ‘‘(C) COORDINATION WITH THE DEPART11 MENT OF HEALTH AND HUMAN SERVICES.— 

12 The Secretary may delegate authority to the 

13 Secretary of Health and Human Services to 

14 purchase countermeasures using the Fund. Any 

15 such purchases by the Secretary of Health and 

16 Human Services shall be conducted as if made 

17 by the Secretary under this section. 

18 ‘‘(D) CONDITIONS FOR PURCHASE.— 

19 ‘‘(i) IN GENERAL.—Payments for pur20 chases under subparagraph (A)(i) shall be 

21 made under such terms and conditions as 

22 are set forth in the contract between the 

23 parties. 

24 ‘‘(ii) DETERMINATIONS.—The deter25 minations required under section 319F– 
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1 2(c) of the Public Health Service Act shall 

2 not be required with respect to a contract, 

3 grant, or other transaction funded by the 

4 Fund under this section. 

5 ‘‘(E) ADVANCE, PARTIAL, PROGRESS, OR

6 OTHER PAYMENTS.— 

7 ‘‘(i) IN GENERAL.—The Secretary 

8 may make payments under subparagraph 

9 (A)(ii) to manufacturers of counter10 measures prior to the final purchase of 

11 such countermeasure. 

12 ‘‘(ii) BASIS FOR PAYMENTS.—Pay13 ments under this subparagraph shall be 

14 based on— 

15 ‘‘(I) the performance of the man16 ufacturer involved as measured by the 

17 Secretary using objective, quantifiable 

18 methods (such as delivery of accept19 able items, work measurement, or sta20 tistical process controls) established 

21 by the Secretary; 

22 ‘‘(II) the accomplishment of 

23 events or milestones as defined in a 

24 program management plan that is de-
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1 veloped by the manufacturer and sub2 mitted to the Secretary; or 

3 ‘‘(III) other quantifiable meas4 ures of results determined appropriate 

5 by the Secretary. 

6 ‘‘(iii) NUMBER, TIME, AND AMOUNT

7 OF PAYMENTS.— 

8 ‘‘(I) IN GENERAL.—The Sec9 retary shall, with respect to a manu10 facturer of a countermeasure, deter11 mine the number of payments to be 

12 made, the timing of such payments, 

13 and subject to subclause (II), the 

14 amount of each such payment. 

15 ‘‘(II) LIMITATION.—The amount 

16 of a partial payment made to a manu17 facturer under this subparagraph 

18 shall not exceed the portion of the 

19 total purchase price (described in sub20 paragraph (B)) for the counter21 measure that remains unpaid as of 

22 the date of the payment involved. 

23 ‘‘(iv) CONDITIONS FOR PAYMENT.— 

24 The Secretary shall ensure that any pay25 ment to which this subparagraph applies is 
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1 commensurate with the actions taken by 

2 the manufacturer and the progress made 

3 in achieving the performance measures 

4 under clause (ii)(I) through the time of 

5 such payment. The manufacturer shall 

6 provide such information and evidence as 

7 such Secretary determines necessary to de8 termine compliance with the preceding sen9 tence. 

10 ‘‘(v) INDEPENDENT RESEARCH AND

11 DEVELOPMENT COSTS.—The payment 

12 amount under this subparagraph may in13 clude the costs associated with independent 

14 research and development undertaken by 

15 the manufacturer prior to entering into a 

16 contract or other agreement with the Sec17 retary under this section. 

18 ‘‘(4) AUTHORITY TO CONTRACT.— 

19 ‘‘(A) IN GENERAL.—For purposes of a 

20 procurement under this subsection, the Sec21 retary shall have responsibilities described in 

22 subparagraphs (B) and (C). 

23 ‘‘(B) PROCUREMENT.— 

24 ‘‘(i) IN GENERAL.—The Secretary 

25 shall be responsible for— 
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1 ‘‘(I) arranging for procurement 

2 of a countermeasure, including negoti3 ating terms (including quantity, pro4 duction schedule, and price) of, and 

5 entering into contracts, cooperative 

6 agreements, or other transactions, and 

7 for carrying out such other activities 

8 as may reasonably be required; and 

9 ‘‘(II) promulgating such regula10 tions as the Secretary determines nec11 essary to implement the provisions of 

12 this subsection. 

13 ‘‘(ii) OTHER TRANSACTION AUTHOR14 ITY, ADDITIONAL AUTHORITY FOR RE15 SEARCH PROJECTS.—The Secretary shall 

16 have the authority to enter into trans17 actions (other than procurement contracts, 

18 grants, and cooperative agreements), in19 cluding transactions for prototypes, to the 

20 same extent as provided to the Secretary 

21 of Defense under section 2371 of title 10, 

22 United States Code, for purposes of car23 rying out the objectives of the Project Bio24 Shield II Act of 2005. 

25 ‘‘(iii) CONTRACT TERMS.— 
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1 ‘‘(I) MANDATORY TERMS.—A 

2 contract for procurement under this 

3 subsection shall include the following 

4 terms: 

5 ‘‘(aa) CONTRACT DURA6 TION.—The contract shall be for 

7 a period not to exceed 10 years, 

8 except that, in first awarding the 

9 contract, the Secretary may pro10 vide for a longer duration, not 

11 exceeding a total of 18 years, if 

12 the Secretary determines that 

13 complexities or other difficulties 

14 in performance under the con15 tract justify such an extended pe16 riod. The contract shall be renew17 able for additional periods, none 

18 of which shall exceed 5 years. 

19 ‘‘(bb) PRODUCT AP20 PROVAL.—The contract shall pro21 vide that the vendor seek ap22 proval, clearance, or licensing or 

23 validating of the product from 

24 the Secretary or other appro25 priate Federal agency and for a 
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1 timetable for the development of 

2 data and other information to 

3 support such approval, clearance, 

4 or licensing, and that the Sec5 retary may waive part or all of 

6 such contract term on request of 

7 the vendor or on the initiative of 

8 the Secretary. 

9 ‘‘(II) STORAGE BY VENDOR.—A 

10 contract for procurement under this 

11 subsection may provide that the ven12 dor provide storage for stocks of a 

13 product delivered to the ownership of 

14 the Federal Government under the 

15 contract, for such period and under 

16 such terms and conditions as the Sec17 retary may specify, and in such case 

18 amounts from the purchase fund 

19 under subsection (a) shall be available 

20 for costs of shipping, handling, stor21 age, and related costs for such prod22 uct. 

23 ‘‘(III) WARM INDUSTRIAL BASE

24 FEE.—A contract for procurement 

25 under this section may provide that 
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1 the vendor receive a fee for estab2 lishing and maintaining manufac3 turing capacity in excess of the initial 

4 requirement of purchase of the coun5 termeasure, in order to ensure that 

6 the Secretary has available a warm in7 dustrial base in the event of the need 

8 to increase purchases of counter9 measures. To the extent practicable, 

10 the Secretary shall modify contracts 

11 in existence on the date of enactment 

12 of this Act to have available a warm 

13 industrial base. The cost of maintain14 ing a warm industrial base shall be an 

15 allowable and allocable direct cost to 

16 the contract. 

17 ‘‘(IV) PURCHASE OF FDA LI18 CENSED PRODUCTS.—Nothing in this 

19 section shall be construed to prevent 

20 the Secretary from purchasing coun21 termeasures that are licensed by the 

22 Food and Drug Administration for 

23 the indicated use or, in the event of a 

24 countermeasure that is established to 

25 be safe and effective for uses other 
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1 than those indicated on the label of 

2 such countermeasure, a use for which 

3 the vendor may be approved under 

4 emergency use authorities or approval 

5 by the Food and Drug Administration 

6 subsequent to purchase. 

7 ‘‘(V) OTHER CONTRACT RE8 QUIREMENTS.— 

9 ‘‘(aa) COST ACCOUNTING

10 STANDARD.—Notwithstanding 

11 any other provision of law, the 

12 cost accounting standards set 

13 forth under chapter 99 of title 

14 48, Code of Federal Regulations, 

15 the cost principles set forth 

16 under part 31 of title 48, Code of 

17 Federal Regulations, and the re18 quirement for submission of cer19 tified cost and pricing data under 

20 section 304A of the Federal 

21 Property and Administrative 

22 Services Act of 1949 (41 U.S.C. 

23 254b) shall not apply to any con24 tract, grant, or cooperative agree25 ment entered into under the 
18 

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1 Project BioShield Act of 2004 

2 (or the amendments made to 

3 such Act by the Project Bio4 Shield II Act of 2005.). 

5 ‘‘(bb) SINGLE TRANS6 ACTION.—The Secretary shall, to 

7 the extent practicable, enter into 

8 a single transaction with each 

9 contractor for the procurement of 

10 countermeasures, even if addi11 tional research and development 

12 of such countermeasures may be 

13 required, so long as the Secretary 

14 determines that sufficient and 

15 satisfactory clinical experience or 

16 research data supports a reason17 able conclusion that such security 

18 countermeasures will qualify for 

19 approval or licensing by the Food 

20 and Drug Administration within 

21 8 years from the date of entering 

22 into the procurement transaction. 

23 ‘‘(iv) PROCUREMENT OF MULTIPLE

24 PRODUCT AND TECHNOLOGIES.—Notwith25 standing any other provision of law, the 
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1 Secretary shall, to the maximum extent 

2 practicable, enter into multiple trans3 actions for the procurement of multiple 

4 technologies and products from multiple 

5 manufacturers of countermeasures in order 

6 to mitigate the risks associated with de7 pendence on a single supplier or tech8 nology. 

9 ‘‘(v) SINGLE TRANSACTION.—The 

10 Secretary shall, to the extent practicable, 

11 enter into a single transaction for the pro12 curement of countermeasures, even if addi13 tional research and development of such 

14 countermeasures may be required, so long 

15 as the Secretary determines that sufficient 

16 and satisfactory clinical experience or re17 search data supports a reasonable conclu18 sion that such security countermeasures 

19 will qualify for approval or licensing by the 

20 Food and Drug Administration within 8 

21 years from the date of entering into the 

22 procurement transaction. The fact that an 

23 entity has not filed for investigational new 

24 drug status with the Food and Drug Ad25 ministration, or has filed for such status 
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1 but has not yet been approved, shall not be 

2 the sole basis for a determination by the 

3 Secretary with respect to whether a coun4 termeasure qualifies for approval or licens5 ing by the Food and Drug Administration 

6 not more than 8 years from the date of the 

7 procurement transaction. 

8 ‘‘(vi) AVAILABILITY OF SIMPLIFIED

9 ACQUISITION PROCEDURES.— 

10 ‘‘(I) IN GENERAL.—If the Sec11 retary determines that there is a 

12 pressing need for a procurement of a 

13 specific countermeasure, the amount 

14 of the procurement under this sub15 section shall be deemed to be below 

16 the threshold amount specified in sec17 tion 4(11) of the Office of Federal 

18 Procurement Policy Act (41 U.S.C. 

19 403(11)), for purposes of application 

20 to such procurement, pursuant to sec21 tion 302A(a) of the Federal Property 

22 and Administrative Services Act of 

23 1949 (41 U.S.C. 252a(a)), of— 

24 ‘‘(aa) section 303(g)(1)(A) 

25 of the Federal Property and Ad-
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1 ministrative Services Act of 1949 

2 (41 U.S.C. 253(g)(1)(A)) and its 

3 implementing regulations; and 

4 ‘‘(bb) section 302A(b) of 

5 such Act (41 U.S.C. 252a(b)) 

6 and its implementing regulations. 

7 ‘‘(II) APPLICATION OF CERTAIN

8 PROVISIONS.—Notwithstanding sub9 clause (I) and the provisions of law 

10 and regulations referred to in such 

11 clause, each of the following provi12 sions shall apply to procurements de13 scribed in this clause to the same ex14 tent that such provisions would apply 

15 to such procurements in the absence 

16 of subclause (I): 

17 ‘‘(aa) Chapter 37 of title 40, 

18 United States Code (relating to 

19 contract work hours and safety 

20 standards). 

21 ‘‘(bb) Subsections (a) and 

22 (b) of section 7 of the Anti-Kick23 back Act of 1986 (41 U.S.C. 57 

24 (a) and (b)). 
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1 ‘‘(cc) Section 304C of the 

2 Federal Property and Adminis3 trative Services Act of 1949 (41 

4 U.S.C. 254d) (relating to the ex5 amination of contractor records). 

6 ‘‘(dd) Section 3131 of title 

7 40, United States Code (relating 

8 to bonds of contractors of public 

9 buildings or works). 

10 ‘‘(ee) Subsection (a) of sec11 tion 304 of the Federal Property 

12 and Administrative Services Act 

13 of 1949 (41 U.S.C. 254(a)) (re14 lating to contingent fees to mid15 dlemen). 

16 ‘‘(ff) Section 6002 of the 

17 Solid Waste Disposal Act (42 

18 U.S.C. 6962). 

19 ‘‘(gg) Section 1354 of title 

20 31, United States Code (relating 

21 to the limitation on the use of 

22 appropriated funds for contracts 

23 with entities not meeting vet24 erans employment reporting re25 quirements). 
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1 ‘‘(III) INTERNAL CONTROLS TO

2 BE ESTABLISHED.—The Secretary 

3 shall establish appropriate internal 

4 controls for procurements made under 

5 this clause, including requirements 

6 with respect to documentation of the 

7 justification for the use of the author8 ity provided under this paragraph 

9 with respect to the procurement in10 volved. 

11 ‘‘(IV) AUTHORITY TO LIMIT COM12 PETITION.—In conducting a procure13 ment under this subparagraph, the 

14 Secretary may not use the authority 

15 provided for under subclause (I) to 

16 conduct a procurement on a basis 

17 other than full and open competition 

18 unless the Secretary determines that 

19 the mission of the BioShield Program 

20 under the Project BioShield II Act of 

21 2005 would be seriously impaired 

22 without such a limitation. 

23 ‘‘(vii) PROCEDURES OTHER THAN

24 FULL AND OPEN COMPETITION.— 
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1 ‘‘(I) IN GENERAL.—In using the 

2 authority provided in section 

3 303(c)(1) of the Federal Property and 

4 Administrative Services Act of 1949 

5 (41 U.S.C. 253(c)(1)) to use proce6 dures other than competitive proce7 dures in the case of a procurement 

8 under this subsection, the phrase 

9 ‘available from only one responsible 

10 source’ in such section 303(c)(1) shall 

11 be deemed to mean ‘available from 

12 only one responsible source or only 

13 from a limited number of responsible 

14 sources’. 

15 ‘‘(II) RELATION TO OTHER AU16 THORITIES.—The authority under 

17 subclause (I) is in addition to any 

18 other authority to use procedures 

19 other than competitive procedures. 

20 ‘‘(III) APPLICABLE GOVERNMENT

21 WIDE REGULATIONS.—The Secretary 

22 shall implement this clause in accord23 ance with regulations implementing 

24 such section 303(c)(1) (including re25 quirements that offers be solicited 
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1 from as many potential sources as is 

2 practicable under the circumstances, 

3 that required notices be published, 

4 and that submitted offers be consid5 ered), as such regulations apply to 

6 procurements for which an agency has 

7 authority to use procedures other than 

8 competitive procedures when the prop9 erty or services needed by the agency 

10 are available from only one respon11 sible source or only from a limited 

12 number of responsible sources and no 

13 other type of property or services will 

14 satisfy the needs of the agency. 

15 ‘‘(viii) PREMIUM PROVISION IN MUL16 TIPLE AWARD CONTRACTS.— 

17 ‘‘(I) IN GENERAL.—If, under this 

18 subsection, the Secretary enters into 

19 contracts with more than one vendor 

20 to procure a countermeasure, such 

21 Secretary may, notwithstanding any 

22 other provision of law, include in each 

23 of such contracts a provision that 

24 identifies an increment of the total 

25 quantity of countermeasure required, 
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1 whether by percentage or by numbers 

2 of units. 

3 ‘‘(II) DETERMINATION OF GOV4 ERNMENT’S REQUIREMENT NOT RE5 VIEWABLE.—If the Secretary includes 

6 in each of a set of contracts a provi7 sion as described in subclause (I), 

8 such Secretary’s determination of the 

9 total quantity of countermeasures re10 quired, and any amendment of such 

11 determination, is committed to agency 

12 discretion. 

13 ‘‘(ix) EXTENSION OF CLOSING DATE; 

14 RECEIPT OF PROPOSALS NOT REVIEW15 ABLE.—A decision by the Secretary to ex16 tend the closing date for receipt of pro17 posals for a procurement under this sub18 section is committed to agency discretion. 

19 ‘‘(x) LIMITING COMPETITION TO

20 SOURCES RESPONDING TO REQUEST FOR

21 INFORMATION.—In conducting a procure22 ment under this subsection, the Secretary 

23 may exclude a source that has not re24 sponded to a request for information under 

25 section 303A(a)(l)(B) of the Federal Prop-
27 

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1 erty and Administrative Services Act of 

2 1949 (41 U.S.C. 253a(a)(1)(B)) if such re3 quest has given notice that the Secretary 

4 may so exclude such a source. 

5 ‘‘(C) COUNTERMEASURES PURCHASED.— 

6 Any stockpiles of countermeasures purchased 

7 under this section may be held in the strategic 

8 national stockpile under section 319F–2 of the 

9 Public Health Service Act (42 U.S.C. 247d– 

10 6b). 

11 ‘‘(5) REQUIREMENTS FOR MANUFACTURERS.— 

12 The Secretary, or the Secretary of Health and 

13 Human Services under delegated authority, shall 

14 provide to manufacturers to the extent feasible the 

15 logistical and operational requirements of counter16 measures prior to their development and acquisition. 

17 The logistical and operational requirements will con18 sider public health needs as well as requirements for 

19 storage, maintenance, security, rotation, and trans20 port of any countermeasures purchased through the 

21 Countermeasure Purchase Fund. 

22 ‘‘(6) COORDINATION.—Consistent with the pro23 visions of section 319F–2(c)(2)(B) of the Public 

24 Health Service Act, the Secretary shall coordinate 

25 with the Secretary of Health and Human Services to 
28 

S 975 IS 

1 store, maintain, secure, rotate, and transport any 

2 materiel purchased through the Countermeasure 

3 Purchase Fund and designated for use in the Stra4 tegic National Stockpile under such section 319F–2. 

5 ‘‘(7) APPROPRIATION.— 

6 ‘‘(A) IN GENERAL.—The total appropria7 tions made available for both the Fund under 

8 section 512 and the special reserve fund under 

9 section 510 may be used to provide funding for 

10 activities conducted by the Secretary and, where 

11 appropriate, the Secretary of Health and 

12 Human Services, in accordance with the Project 

13 BioShield Act of 2004 and the Project Bio14 Shield II Act of 2005 (and the amendments 

15 made by such Acts). 

16 ‘‘(B) USE OF FUNDS.—The Secretary, or 

17 the Secretary of Health and Human Services 

18 under delegated authority, may use the funds 

19 under this section to cover the costs of storage, 

20 maintenance, security, rotation, and transport 

21 of any material purchased through the Counter22 measure Purchase Fund.’’. 

23 ‘‘(b) DEFINITION.—In this section, the term ‘coun24 termeasure’ has the meaning given such term in section 

25 319F–3 of the Public Health Service Act.’’. 
29 

S 975 IS 

1 SEC. 102. ADDITIONAL AUTHORITY UNDER PROJECT BIO2 SHIELD. 

3 (a) ADDITIONAL AUTHORITY FOR RESEARCH

4 PROJECTS.—Section 319F–1 of the Public Health Service 

5 Act (42 U.S.C. 247d–6a) is amended by— 

6 (1) redesignating subsection (f) as subsection 

7 (g); and 

8 (2) inserting after subsection (e) the following: 

9 ‘‘(f) OTHER TRANSACTION AUTHORITY.—The Sec10 retary shall have the authority to enter into transactions 

11 (other than procurement contracts, grants, and coopera12 tive agreements), including transactions for prototypes, to 

13 the same extent as provided to the Secretary of Defense 

14 under section 2371 of title 10, United States Code, for 

15 purposes of carrying out the objectives of the Project Bio16 Shield Act of 2004.’’. 

17 (b) ENCOURAGEMENT OF TECHNOLOGY TRANSFER

18 AND COMMERCIALIZATION.—Section 319F–2(c)(5)(B)(iii) 

19 of the Public Health Service Act (42 U.S.C. 247d– 

20 6b(c)(5)(B)(iii)) is amended to read as follows: 

21 ‘‘(iii) Where there is a potential to 

22 transfer the technology developed as a se23 curity countermeasure to the commercial 

24 market, either as a countermeasure to be 

25 sold in foreign markets or, if the counter26 measure has beneficial use and utility for 
30 

S 975 IS 

1 indications other than chemical, biological, 

2 radiological, or nuclear protection, for use 

3 as other than a countermeasure in com4 mercial markets thus meriting Federal 

5 funding to stimulate and encourage such 

6 commercialization and technology transfer, 

7 and demonstrating a potential return on 

8 such Federal investment.’’. 

9 (c) PROCUREMENT OF CERTAIN COUNTER10 MEASURES.—Section 319F–2 of the Public Health Service 

11 Act (42 U.S.C. 247d–6b) is amended by— 

12 (1) redesignating subsections (e) and (f) as sub13 sections (l) and (m), respectively; and 

14 (2) by inserting after subsection (d) the fol15 lowing: 

16 ‘‘(e) PROCUREMENT OF CERTAIN COUNTER17 MEASURES.— 

18 ‘‘(1) IN GENERAL.—The Secretary shall, to the 

19 extent practicable, enter into transactions for the 

20 procurement of security countermeasures, even if ad21 ditional research and development of such security 

22 countermeasures may be required, so long as the 

23 Secretary determines that sufficient and satisfactory 

24 clinical experience or research data supports a rea25 sonable conclusion that such security counter-
31 

S 975 IS 

1 measures will qualify for approval or licensing by the 

2 Food and Drug Administration within 8 years from 

3 the date of entering into the procurement trans4 action. 

5 ‘‘(2) BASIS FOR DETERMINATION.—The fact 

6 that an entity has not filed for Investigational New 

7 Drug status with the Food and Drug Administra8 tion, or has filed for such status but has not yet 

9 been approved, shall not be the sole basis for a de10 termination by the Secretary with respect to whether 

11 a security countermeasure qualifies for approval or 

12 licensing by the Food and Drug Administration 

13 within 8 years from the date of entering into the 

14 procurement transaction. 

15 ‘‘(f) EFFECT OF SECTION.—Notwithstanding any 

16 other provision of law, the cost accounting standards set 

17 forth under chapter 99 of title 48, Code of Federal Regu18 lations, the cost principles set forth under part 31 of title 

19 48, Code of Federal Regulations, and the requirement of 

20 the submission of certified cost and pricing information 

21 under section 254b of title 41, United States Code, shall 

22 not apply to any contract, grant, or cooperative agreement 

23 entered into under the Project BioShield Act of 2004 (or 

24 the amendments made to such Act by the Project Bio25 Shield II Act of 2005). 
32 

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1 ‘‘(g) ACCELERATED APPROVAL.—An entity that en2 ters into an agreement under this section, section 319F– 

3 1, or section 512 of the Homeland Security Act of 2002 

4 shall be eligible for accelerated approval of a counter5 measure in accordance with section 573 of the Federal 

6 Food, Drug, and Cosmetic Act. 

7 ‘‘(h) PROCUREMENT OF MULTIPLE PRODUCT AND

8 TECHNOLOGIES.—Notwithstanding any other provision of 

9 law, the Secretary shall, to the extent practicable, enter 

10 into multiple transactions for the procurement of multiple 

11 technologies and products from multiple manufacturers of 

12 qualified and security countermeasures (as defined by this 

13 section and section 319F–1) in order to mitigate the risks 

14 associated with dependence on a single supplier or tech15 nology. 

16 ‘‘(i) WARM INDUSTRIAL BASE FEE.—A contract for 

17 procurement under this section may provide that the ven18 dor receive a fee for establishing and maintaining manu19 facturing capacity in excess of the initial requirement of 

20 purchase of the countermeasure, in order to ensure that 

21 the Secretary has available a warm industrial base in the 

22 event of the need to increase purchases of counter23 measures. To the extent practicable, the Secretary shall 

24 modify contracts in existence on the date of enactment of 

25 this subsection to have available a warm industrial base. 
33 

S 975 IS 

1 The Secretary shall deem the cost of such fee allowable 

2 and allocable as a direct cost to the contract. 

3 ‘‘(j) PURCHASE OF FDA LICENSED PRODUCTS.— 

4 Nothing in this section shall be construed to prevent the 

5 Secretary from purchasing countermeasures that are li6 censed by the Food and Drug Administration for the indi7 cated use or, in the event of a countermeasure that is es8 tablished to be safe and effective for uses other than those 

9 indicated on the label of such countermeasure, a use for 

10 which the vendor may be approved under emergency use 

11 authorities or approval by the Food and Drug Administra12 tion subsequent to purchase.’’. 

13 (d) TECHNICAL AMENDMENTS.—Section 319F–2 of 

14 the Public Health Service Act (42 U.S.C. 247d–6b) is 

15 amended by— 

16 (1) in the section heading, inserting ‘‘and Secu17 rity Countermeasure Procurements’’ after ‘‘Stock18 pile’’; and 

19 (2) in subsection (c)— 

20 (A) in the heading, by deleting ‘‘bio21 medical’’; 

22 (B) in paragraph (5)— 

23 (i) by amending subparagraph (A) to 

24 read as follows: 
34 

S 975 IS 

1 ‘‘(A) IN GENERAL.—The Secretary, in ac2 cordance with the provisions of this paragraph, 

3 shall identify specific security countermeasures 

4 that the Secretary determines, in consultation 

5 with the Homeland Security Secretary, to be 

6 appropriate for inclusion in the stockpile under 

7 subsection (a) or acquisition for other purposes 

8 pursuant to procurements made with amounts 

9 in the special reserve fund under paragraph 

10 (10) (referred to in this subsection individually 

11 as a ‘‘procurement under this subsection’’).’’; 

12 and 

13 (ii) in subparagraph (B)(ii), by delet14 ing the word ‘‘stockpile’’ and inserting 

15 ‘‘government’’; 

16 (C) by amending paragraph (6)(D) to read 

17 as follows: 

18 ‘‘(D) Subsequent specific counter19 measures.—Procurement under this subsection 

20 of a security countermeasure for a particular 

21 purpose does not preclude the subsequent pro22 curement under this subsection of any other se23 curity countermeasure for such purpose if the 

24 Secretary has determined under paragraph 

25 (5)(A) that such countermeasure is appropriate 
35 

S 975 IS 

1 for inclusion in the stockpile or acquisition for 

2 other purposes and if, as determined by the 

3 Secretary, such countermeasure provides im4 proved safety or effectiveness, or for other rea5 sons enhances preparedness to respond to 

6 threats of use of a biological, chemical, radio7 logical, or nuclear agent. Such a determination 

8 by the Secretary is committed to agency discre9 tion.’’; and 

10 (D) in paragraph (8)— 

11 (i) in subparagraph (A)— 

12 (I) by striking ‘‘COOPERATION.— 

13 ’’ and all that follows through ‘‘out’’ 

14 and inserting ‘‘COOPERATION.—In 

15 carrying out’’; and 

16 (II) by striking ‘‘, subject to sub17 paragraph (B),’’; and 

18 (ii) by striking subparagraph (B). 

19 SEC. 103. REQUEST OF AGENCY. 

20 Section 319F–2 of the Public Health Service Act (42 

21 U.S.C. 247d–6b) (as amended by section 102) is further 

22 amended by inserting after subsection (j) the following: 

23 ‘‘(k) REQUEST OF AGENCY TO USE BIOSHIELD I 

24 AND BIOSHIELD II AUTHORITY AND INCENTIVES.— 
36 

S 975 IS 

1 ‘‘(1) IN GENERAL.—Upon request by a Federal 

2 agency, the Secretary may establish interagency 

3 agreements, under terms acceptable to the Sec4 retary, in which such agency may order counter5 measures under procurement contracts or procure6 ment pools established by the Secretary. 

7 ‘‘(2) PROCESSING OF ORDERS.—The ordering 

8 of a countermeasure under an agreement under 

9 paragraph (1) (including transfers of appropriated 

10 funds between an agency and the Department to pay 

11 for such orders) may be conducted pursuant to sec12 tion 1535 of title 31, United States Code, if such 

13 order is processed under the terms established— 

14 ‘‘(A)(1) in the interagency agreement re15 quired by subsection (c)(7)(B), for orders of de16 tection technology and decontamination tech17 nology placed by the Department of Homeland 

18 Security; or 

19 ‘‘(2) by the Secretary in the interagency 

20 agreement described under paragraph (1) for 

21 all other orders; and 

22 ‘‘(B) in the Project BioShield Act of 2004 

23 and the Project BioShield II Act of 2005 (and 

24 the amendments made by such Acts) with re-
37 

S 975 IS 

1 spect to the procurement of countermeasures 

2 under this section and section 319F–1.’’. 

3 TITLE II—AMENDMENTS TO THE 

4 PROJECT BIOSHIELD ACT OF 

5 2004 REGARDING INFECTIOUS 

6 DISEASE COUNTER7 MEASURES; ADDITIONAL PRO8 VISIONS 

9 SEC. 201. AMENDMENTS TO THE PROJECT BIOSHIELD ACT 

10 OF 2004 REGARDING INFECTIOUS DISEASE 

11 COUNTERMEASURES. 

12 (a) COUNTERMEASURES TO DETECT, DIAGNOSE, 

13 PREVENT, OR TREAT AN INFECTIOUS DISEASE.— 

14 (1) PROCUREMENT AUTHORITY.—Section 

15 319F–1(a)(2) of the Public Health Service Act (42 

16 U.S.C. 247d–6a) is amended— 

17 (A) in subparagraph (A), by striking ‘‘; 

18 or’’ and inserting a semicolon; 

19 (B) in subparagraph (B), by striking the 

20 period and inserting ‘‘; or’’; and 

21 (C) by adding after subparagraph (B) the 

22 following: 

23 ‘‘(C) detect, diagnose, treat, or prevent an 

24 infectious disease (as defined in section 319F– 

25 3(a)(6)) adversely affecting public health.’’. 
38 

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1 (2) STRATEGIC NATIONAL STOCKPILE.—Section 

2 319F–2(c)(1)(B) of the Public Health Service Act is 

3 amended— 

4 (A) in clause (i)(III)(bb), by striking ‘‘; 

5 or’’ and inserting a semicolon; 

6 (B) in clause (ii), by striking the period 

7 and inserting ‘‘; or’’; and 

8 (C) by adding at the end the following: 

9 ‘‘(iii) is intended to detect, diagnose, 

10 prevent, or treat an infectious disease (as 

11 defined in section 319–3(a)(6)).’’. 

12 SEC. 202. PROCUREMENT POOLS; ADDITIONAL INCENTIVES 

13 UNDER PROJECT BIOSHIELD. 

14 (a) IN GENERAL.—Part B of title III of the Public 

15 Health Service Act (42 U.S.C. 243 et seq.), as amended 

16 by section 101, is amended by inserting after section 

17 319F–2 the following: 

18 ‘‘SEC. 319F–3. PROCUREMENT OF CERTAIN DRUGS, DETEC19 TION TECHNOLOGY, DIAGNOSTICS, AND RE20 SEARCH TOOLS. 

21 ‘‘(a) DEFINITIONS.—For purposes of this part: 

22 ‘‘(1) BIOLOGICAL OR CHEMICAL AGENT; TOXIN; 

23 NUCLEAR OR RADIOLOGICAL MATERIAL; TERROR

24 WEAPON.—The term— 
39 

S 975 IS 

1 ‘‘(A) ‘biological agent’, ‘biological toxin’, or 

2 ‘chemical agent’, or any variation of any such 

3 term, includes any microorganism, virus, infec4 tious substance, toxic biological product, or 

5 toxic or poisonous chemical, that may be used 

6 in a manner that may cause widespread death 

7 or serious bodily injury, including biological 

8 agents and toxins described in paragraphs (1) 

9 and (2) of section 178 of title 18, United States 

10 Code; 

11 ‘‘(B) ‘nuclear or radiological material’ 

12 means any radioactive material that may be 

13 used in a manner that may cause widespread 

14 death or serious bodily injury; and 

15 ‘‘(C) ‘terror weapon’ or ‘weapon of mass 

16 destruction’ mean any matter described in sub17 paragraph (A) or (B) that may be used in a 

18 manner that may cause widespread death or se19 rious bodily injury. 

20 ‘‘(2) COUNTERMEASURE.—The term ‘counter21 measure’ means— 

22 ‘‘(A) a vaccine and related delivery system, 

23 anti-infective, antibiotic or combinations there24 of, therapy, microbicide, diagnostic technology, 

25 drug, biological product, chemical, or other 
40 

S 975 IS 

1 technology that is subject to applicable provi2 sions of this Act, the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 301 et seq.), or the 

4 Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.), 

5 and that prevents infection with, or the spread 

6 of, or the directly diagnose, treat, or prevent 

7 the pathological effects of infection with, bodily 

8 harm from, or the spread of, a biological or 

9 chemical agent or toxin on the list described in 

10 subsection (f), including treatments for address11 ing excessive bleeding and other trauma fol12 lowing a terrorist attack; 

13 ‘‘(B) a therapy, diagnostic, or piece of 

14 equipment that may be used to detect, treat, or 

15 prevent bodily harm that may be caused by the 

16 use of biological, chemical, nuclear, or radio17 logical material as a terror weapon or by an in18 fectious disease; 

19 ‘‘(C) a qualified countermeasure, as de20 fined in section 319F–1; or 

21 ‘‘(D) a security countermeasure, as defined 

22 in section 319F–2. 

23 ‘‘(3) DECONTAMINATION TECHNOLOGY.—The 

24 term ‘decontamination technology’ means a product 
41 

S 975 IS 

1 or service used for the decontamination of property 

2 following a terrorist attack. 

3 ‘‘(4) DETECTION TECHNOLOGY.—The term ‘de4 tection technology’ means scientific instruments, 

5 consumables (such as reagents or assays, including 

6 reagents or assays using polymerase chain reaction 

7 (PCR) or Real Time PCR), software, or services for 

8 the detection of the presence, concentration, charac9 teristics, or identification of a biological, chemical, 

10 nuclear, radiological agent, or infectious disease in 

11 environmental or field samples. 

12 ‘‘(5) DEVELOPMENT.—The term ‘development’ 

13 or ‘to develop’ includes research leading to the iden14 tification and isolation of suitable compounds or bio15 logical materials, the engineering, modification (in16 cluding research leading to the expanded use of cur17 rently approved drugs or biological products), eval18 uation, production, and formulation of such com19 pounds or materials, the conduct of preclinical and 

20 clinical studies, the preparation of an application for 

21 marketing approval, and preparation of test meth22 ods, with respect to countermeasures regulated by 

23 the Food and Drug Administration, and other ac24 tions prior to approval of a countermeasure by the 

25 Food and Drug Administration or when it is pro-
42 

S 975 IS 

1 cured as an unlicensed countermeasure under sec2 tion 319F–2(e). 

3 ‘‘(6) DIAGNOSTICS.— 

4 ‘‘(A) IN GENERAL.—The term ‘diagnostics’ 

5 includes products, devices, and technologies to 

6 detect, identify, or analyze the potential pres7 ence of, or exposure to, 1 or more biological, 

8 nuclear, radiological, or chemical agent or toxin 

9 in potentially exposed individuals through 

10 means to enable effective medical intervention 

11 through the administration of appropriate coun12 termeasures. 

13 ‘‘(B) INCLUSION.—The term ‘diagnostics’ 

14 includes technologies that diagnose or screen 

15 for the health and safety of potentially exposed 

16 individuals and products that serve as 

17 contraindicators for vaccines or drugs. 

18 ‘‘(7) INFECTIOUS DISEASE.— 

19 ‘‘(A) IN GENERAL.—The term ‘infectious 

20 disease’ means a disease in humans caused 

21 by— 

22 ‘‘(i) a microbe (including a bacteria, 

23 virus, fungus, or parasite) that is acquired 

24 by a person and that reproduces in that 

25 person; 
43 

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1 ‘‘(ii) microbial products (such as botu2 linum toxin); or 

3 ‘‘(iii) a prion. 

4 ‘‘(B) INCLUSION.—The term ‘infectious 

5 disease’ includes— 

6 ‘‘(i) a disease in humans caused by a 

7 microorganism, whether or not— 

8 ‘‘(I) such microorganism is ac9 quired by an individual through 

10 human-to-human contact; or 

11 ‘‘(II) if the individual is initially 

12 symptomatic of the disease; and 

13 ‘‘(ii) zoonotic diseases that may find 

14 hosts in animal and human populations. 

15 ‘‘(8) MANUFACTURER.— 

16 ‘‘(A) IN GENERAL.—The term ‘manufac17 turer’ means an entity responsible for research, 

18 evaluation, development, or production of a 

19 countermeasure and, except for a counter20 measure that is not subject to review and ap21 proval by the Food and Drug Administration 

22 prior to marketing (such as research tools), the 

23 potential or actual holder of the approved new 

24 drug application, biologic license application, or 
44 

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1 product license application or equivalent for 

2 such countermeasure. 

3 ‘‘(B) LIMITATION.—The term ‘manufac4 turer’ does not require that a manufacturer 

5 conduct the actual research, evaluation, devel6 opment, or production in its own facilities, but 

7 may enter into arrangements with third parties 

8 for the research, evaluation, development, or 

9 production of the countermeasure. 

10 ‘‘(9) RESEARCH TOOL.—The term ‘research 

11 tool’ includes the full range of tools and systems 

12 that accelerate the discovery, development, and man13 ufacture of countermeasures, including animal dis14 ease models, cell lines, cell line cultures for the pro15 duction of biologics, de novo DNA synthesis, 

16 monoclonal and polyclonal antibodies, reagents or 

17 assays (such as those utilizing the polymerase chain 

18 reaction (PCR) or Real Time PCR processes), drug 

19 delivery technologies, vaccine adjuvants, antibiotic 

20 sensitivity screens, laboratory animals, large animals 

21 including nonhuman primates (and other such ani22 mals used or intended to be used for drug produc23 tion), growth factors, combinatorial chemistry and 

24 DNA libraries, vaccine antigen libraries, clones and 

25 cloning tools (such as PCR or Real Time PCR), 
45 

S 975 IS 

1 methods, laboratory equipment and machines, data2 bases, and other technologies that enable the rapid 

3 and effective development of countermeasures, in4 cluding diagnostics, vaccines, drugs, antibiotics, non5 laboratory tools, and tools systems that directly as6 sist such countermeasure development efforts. 

7 ‘‘(b) PROCUREMENT POOLS.— 

8 ‘‘(1) IN GENERAL.—Notwithstanding any other 

9 provision of law, the Secretary shall establish, and 

10 make payments from, procurement pools with re11 spect to the procurement of a qualified counter12 measure under section 319F–1 or a security coun13 termeasure under section 319F–2. 

14 ‘‘(2) ROLE OF OTHER ORGANIZATIONS.—In or15 ganizing the procurement pools under paragraph 

16 (1), the Secretary may accept contributions and 

17 guarantees from— 

18 ‘‘(A) non-governmental organizations; 

19 ‘‘(B) international health agencies; 

20 ‘‘(C) the United Nations; 

21 ‘‘(D) the Global Vaccine Acquisition Initia22 tive; and 

23 ‘‘(E) private nonprofit organizations that 

24 are organized to support international public 

25 health research and programs. 
46 

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1 ‘‘(3) CONSULTATION.—The Secretary shall— 

2 ‘‘(A) consult with the organizations de3 scribed under paragraph (2) regarding the 

4 terms and management of procurement con5 tracts that exceed $25,000,000 in value under 

6 this section and sections 319F–1 and 319F–2 

7 that receive payment from the procurement pool 

8 established under paragraph (1); and 

9 ‘‘(B) provide information to such organiza10 tions regarding such procurement contracts. 

11 ‘‘(4) LIMITATION.—Nothing in this part shall 

12 be construed to prohibit the Secretary or the Sec13 retary of Homeland Security (with respect to pro14 curement agreements under section 512 of the 

15 Homeland Security Act of 2002) from accepting 

16 contributions and guarantees from organizations 

17 that receive funding from the Federal Government. 

18 ‘‘(5) CONTRIBUTION TO OTHER POOLS.—The 

19 Secretary and the Secretary of Homeland Security 

20 (with respect to procurement agreements under sec21 tion 512 of the Homeland Security Act of 2002) 

22 may contribute funds to procurement pools orga23 nized by other entities, such as foreign governments, 

24 the United Nations, or nonprofit or non-govern-
47 

S 975 IS 

1 mental entities for procurement of qualified and se2 curity countermeasures. 

3 ‘‘(c) ADVISORY COMMITTEE.— 

4 ‘‘(1) ESTABLISHMENT.—The Secretary shall es5 tablish an advisory committee to be known as the 

6 International Public Health Advisory Committee (re7 ferred to in this section as the ‘Advisory Com8 mittee’). 

9 ‘‘(2) MEMBERSHIP.— 

10 ‘‘(A) IN GENERAL.—The Advisory Com11 mittee shall be composed of representatives, to 

12 be appointed by the Secretary, from organiza13 tions, including the Centers for Disease Control 

14 and Prevention and the organizations described 

15 in subparagraph (B), with expertise and re16 sources regarding the development and distribu17 tion of countermeasures against biological, 

18 chemical, nuclear, or radiological agents or in19 fectious diseases. 

20 ‘‘(B) ORGANIZATIONS DESCRIBED.—The 

21 organizations described under this subpara22 graph are— 

23 ‘‘(i) non-governmental organizations; 

24 ‘‘(ii) international health agencies; 

25 ‘‘(iii) the United Nations; 
48 

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1 ‘‘(iv) the Global Vaccine Acquisition 

2 Initiative; and 

3 ‘‘(v) private nonprofit organizations 

4 that are organized to support international 

5 public health research and programs. 

6 ‘‘(3) DUTIES OF ADVISORY COMMITTEE.—The 

7 Advisory Committee, through a public process, 

8 shall— 

9 ‘‘(A) develop an international, multi10 faceted, and coordinated strategy, that, with re11 spect to countermeasures against biological, 

12 chemical, radiological, and nuclear agents or in13 fectious disease— 

14 ‘‘(i) develops strategies for estab15 lishing procurement pools; 

16 ‘‘(ii) develops strategies to facilitate 

17 partnerships between the government and 

18 private sector; 

19 ‘‘(iii) makes recommendations for 

20 strengthening the infrastructure necessary 

21 for researching, creating, and stockpiling 

22 critical therapeutics; 

23 ‘‘(iv) recommends ways in which the 

24 countermeasure development process may 

25 be shortened; and 
49 

S 975 IS 

1 ‘‘(v) makes recommendations for pri2 ority areas for developing research and dis3 covery programs necessary to develop 

4 countermeasures; 

5 ‘‘(B) develop criteria for determining which 

6 countermeasures against biological, chemical, 

7 nuclear, and radiological agents or infectious 

8 disease should be developed and procured; 

9 ‘‘(C) explore priority broad spectrum 

10 therapeutics and ways in which the counter11 measure development process may be acceler12 ated to facilitate rapid development of new 

13 drugs in the event of an attack with a pre14 viously unknown biological agent or pathogen; 

15 and 

16 ‘‘(D) recognize the importance and the 

17 need for advancement in the field of 

18 bioinformatics which will accelerate the dis19 covery or development of all types of counter20 measures by promoting the use of advanced 

21 mathematical, computing, or image processing 

22 technologies, including pattern recognition 

23 methods, lossless digital data compression for 

24 storage and transmission of biomedical images, 

25 and the ability to analyze massive amounts of 
50 

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1 data, in order to solve complex research and de2 velopment problems. 

3 ‘‘(d) DIAGNOSTICS INCENTIVES.— 

4 ‘‘(1) IDENTIFICATION.—Not later than 180 

5 days after the date of enactment of the Project Bio6 Shield II Act of 2005, the Secretary shall develop 

7 and make available to potential manufacturers, a list 

8 of the diagnostics that need to be developed to pre9 pare the United States for a terrorist attack using 

10 a biological or chemical agent, infectious disease, 

11 toxin, or nuclear or radiological materials, or to 

12 counter a naturally occurring infectious disease out13 break. The Secretary shall provide such information 

14 as the Secretary determines to be necessary to en15 able such potential manufacturers to structure and 

16 focus their research and development programs for 

17 the development of such research tools. 

18 ‘‘(2) REVISIONS.—The Secretary shall revise 

19 the list developed under paragraph (1) not less often 

20 than annually, and make such list available to poten21 tial manufacturers of diagnostics under terms and 

22 conditions consistent with the security interests of 

23 the United States. 

24 ‘‘(3) DEVELOPMENT OF CERTAIN

25 DIAGNOSTICS.— 
51 

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1 ‘‘(A) IN GENERAL.—The Secretary, acting 

2 through the Assistant Secretary for Public 

3 Health Countermeasure Development, shall de4 velop and implement, in consultation with State 

5 and local public health officials and private sec6 tor entities, a strategy for the development of 

7 infectious disease multiplexed molecular level di8 agnostic screening technologies and the building 

9 of an integrated and standardized information 

10 system linking the Federal, State, and local 

11 public health systems for reporting automated 

12 laboratory results for all toxicology and infec13 tious diseases. The strategy shall address the 

14 integration, correlation, and analysis from lab15 oratory results with data generated from envi16 ronmental monitoring using detection tech17 nology. 

18 ‘‘(B) STRATEGY.—The strategy developed 

19 and implemented pursuant to subparagraph (A) 

20 shall— 

21 ‘‘(i) include the development of con22 firmatory laboratory tests to validate pre23 sumptive results available from initial 

24 screening; 
52 

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1 ‘‘(ii) complement the development of 

2 therapeutics where appropriate; and 

3 ‘‘(iii) promote the advancement of 

4 bioinformatics through the use of incen5 tives, the procurement and rapid develop6 ment of new devices, and the development 

7 of a robust and standardized information 

8 infrastructure for carrying out medical 

9 surveillance tasks. 

10 ‘‘(C) TECHNOLOGY.— 

11 ‘‘(i) IN GENERAL.—The specific 

12 screening and diagnostics technology used 

13 to implement the strategy described in sub14 paragraph (A) may consist of multiplexed 

15 devices that screen for routinely encoun16 tered common infectious diseases and have 

17 biothreat agent detection algorithms em18 bedded in the devices with automatic re19 porting features. 

20 ‘‘(ii) DISSEMINATION AND EVALUA21 TION.—The Secretary shall develop— 

22 ‘‘(I) the methods by which the re23 sults from such detection devices may 

24 be rapidly disseminated to the appro-
53 

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1 priate domestic and international 

2 health care systems; and 

3 ‘‘(II) a system by which the util4 ity of such results, and the efficacy of 

5 such dissemination system, may be 

6 evaluated and improved, as necessary. 

7 ‘‘(4) UTILIZATION OF DIAGNOSTICS BY HEALTH

8 CARE PROVIDERS.— 

9 ‘‘(A) IN GENERAL.—The Secretary shall 

10 develop and implement a strategy that recog11 nizes the need to provide the right incentives to 

12 the health care industry, including the qualified 

13 clinical countermeasures delivery centers under 

14 the Project Bioshield II Act of 2005, to allow 

15 the industry to utilize the new diagnostic tools 

16 that will be made available through research 

17 and allow for screening for infectious diseases 

18 and other biological, chemical, nuclear, radio19 logical, and emerging terrorist threats. 

20 ‘‘(B) REIMBURSEMENT.—The strategy 

21 shall include appropriate incentives to allow for 

22 reimbursement to State and local governments, 

23 hospitals, clinics, and other providers who per24 form laboratory screening utilizing newer molec25 ular level tests that rapidly detect infectious 
54 

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1 diseases and other biological, chemical, nuclear, 

2 radiological, and emerging terrorist threats. 

3 ‘‘(C) STRATEGIES.—The Secretary shall 

4 establish similar strategies for States and local 

5 governments to utilize to promote biological, 

6 chemical, nuclear, radiological, and other 

7 emerging terrorist threats and infectious dis8 eases screening, including testing for the rapid 

9 identification of potential biothreat agents. 

10 ‘‘(5) NO JUDICIAL REVIEW.—Notwithstanding 

11 any other provision of law, there shall be no judicial 

12 review of the list, or revised list, developed by the 

13 Secretary under this subsection. 

14 ‘‘(e) RESEARCH TOOLS INCENTIVES.— 

15 ‘‘(1) IDENTIFICATION.—Not later than 180 

16 days after the date of enactment of the Project Bio17 Shield II Act of 2005, the Secretary shall develop 

18 and make available to potential entities and manu19 facturers, a list of the research tools and the sys20 tems to aid in the development of such tools that 

21 need to be developed to prepare the United States 

22 for a terrorist attack, with a biological or chemical 

23 agent or toxin or nuclear or radiological materials, 

24 or to counter a naturally occurring infectious disease 

25 outbreak. The list developed by the Secretary shall 
55 

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1 include research tools for which there is a need for 

2 development in order to understand why certain 

3 countermeasures may cause adverse events, how to 

4 minimize such adverse events, and how to treat such 

5 adverse events. The Secretary shall provide such in6 formation as the Secretary determines to be nec7 essary to enable such potential manufacturers to 

8 structure and focus their research and development 

9 programs for the development of research tools. 

10 ‘‘(2) REVISIONS.—The Secretary shall revise 

11 the list developed under paragraph (1) not less often 

12 than annually, and make such list available to poten13 tial manufacturers of research tools under terms and 

14 conditions consistent with the security interests of 

15 the United States. 

16 ‘‘(3) NO JUDICIAL REVIEW.—Notwithstanding 

17 any other provision of law, there shall be no judicial 

18 review of the list, or revised list, developed by the 

19 Secretary under this subsection. 

20 ‘‘(4) UTILIZATION AND AVAILABILITY.— 

21 ‘‘(A) IN GENERAL.—Entities that enter 

22 into a contract for procurement of a qualified 

23 countermeasure under section 319F–1 or of a 

24 security countermeasure under section 319F–2, 

25 or under section 512 of the Homeland Security 
56 

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1 Act of 2002 shall maximize the utilization of 

2 the research tools involved for the development 

3 of countermeasures. In addition, such entities 

4 shall promote the advancement of 

5 bioinformatics through the use of incentives for 

6 the development and procurement of 

7 bioinformatics research tools. 

8 ‘‘(B) RULE OF CONSTRUCTION.—Nothing 

9 in this section or chapter 18 of title 35, United 

10 States Code, shall be construed to restrict the 

11 right of an entity described in subparagraph 

12 (A) to— 

13 ‘‘(i) secure and enforce patents with 

14 regard to research tools; 

15 ‘‘(ii) enter into exclusive, revocable, 

16 and nontransferable licenses of such re17 search tools; or 

18 ‘‘(iii) impose limits on royalty- or 

19 product-reach-through or downstream 

20 rights or agreements on future counter21 measures or products, or option rights with 

22 respect to a research tool. 

23 ‘‘(f) INITIAL LIST.—Not later than 180 days after 

24 the date of enactment of the Project BioShield II Act of 

25 2005, the Secretary, in consultation with the Secretary of 
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1 Defense and the Secretary of Homeland Security, shall de2 velop, publish in the Federal Register, and make available 

3 to potential manufacturers of terror weapons and infec4 tious disease countermeasures, except as provided in sub5 section (i), a list of biological and chemical agents, toxins, 

6 and nuclear and radiological materials that may be used 

7 as weapons of mass destruction or that are infectious dis8 eases with respect the which the Secretary finds that re9 search to develop new and improved countermeasures is 

10 in the national interest of the United States. Such initial 

11 list may, at the discretion of the Secretary, contain the 

12 following: 

13 ‘‘(1) Variola major (confluent, flat, and hemor14 rhagic smallpox). 

15 ‘‘(2) Bacillus anthracis (anthrax) or near-neigh16 bor pathogenic Bacillus spp. 

17 ‘‘(3) Clostridium botulinum (botulism) or botu18 lism toxins. 

19 ‘‘(4) Francisella tularensis (tularemia). 

20 ‘‘(5) Yersina pestis (Black Death: bubonic 

21 plague, pneumonic plague). 

22 ‘‘(6) Pathogenic Haemophilus spp. 

23 ‘‘(7) Ebolavirus spp. (Ebola hemorrhagic fever). 

24 ‘‘(8) Marburgvirus spp. (Marburg hemorrhagic 

25 fever). 
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1 ‘‘(9) Arenavirus Lassa Virus (Lassa fever). 

2 ‘‘(10) Arenavirus Junin Virus (Argentine 

3 hemmorrhagic fever). 

4 ‘‘(11) Nairovirus Crimean-Congo hemorrhagic 

5 fever virus (Crimean-Congo hemmorrhagic fever). 

6 ‘‘(12) Coxiella burnetti (Q fever). 

7 ‘‘(13) Coccidioidomycosis immitis (Coccidioi8 domycosis, San Joaquin Valley, or desert fever). 

9 ‘‘(14) Clostridium perfringens (gas gangrene, 

10 necrotizing enteritis). 

11 ‘‘(15) Treponema spp. 

12 ‘‘(16) Borrelia spp. 

13 ‘‘(17) Chlamydia psittaci (parrot fever). 

14 ‘‘(18) Phlebovirus Rift Valley fever virus (Rift 

15 Valley fever). 

16 ‘‘(19) Rickettsia rickettsii (Rocky Mountain 

17 Spotted Fever). 

18 ‘‘(20) Brucella spp. (brucellosis). 

19 ‘‘(21) Burkholderia mallei (glanders). 

20 ‘‘(22) Alphavirus Venezuelan equine encepha21 litis virus (Venezuelan equine encephalomyelitis). 

22 ‘‘(23) Alphavirus Eastern equine encephalitis 

23 virus (Eastern equine encephalomyelitis) and 

24 Alphavirus Western equine encephalitis virus (West25 ern equine encephalomyelitis). 
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1 ‘‘(24) Ricin toxin (castor bean toxin). 

2 ‘‘(25) Trichothecene Mycotoxins. 

3 ‘‘(26) Dinoflagellate neurotoxin (Paralytic 

4 Shellfish Toxin). 

5 ‘‘(27) Aflatoxins. 

6 ‘‘(28) Epsilon toxin of clostridium perfringens. 

7 ‘‘(29) Staphylococcus enterotoxin B (Staphy8 lococcus entertoxin B intoxication). 

9 ‘‘(30) Methicillin-resistant staphylococcus 

10 aureus. 

11 ‘‘(31) Influenza. 

12 ‘‘(32) Avian influenza. 

13 ‘‘(33) Pathogenic Salmonella spp. (gastro14 intestinal upset, enteric fever). 

15 ‘‘(34) Salmonella Typhi (typhoid fever). 

16 ‘‘(35) Shigella dysenteriae (dysentery, hemo17 lytic-uremic syndrome). 

18 ‘‘(36) Escherichia coli 0157:H7 (severe diar19 rhea, hemolytic-uremic syndrome) and other Esch20 erichia coli pathotypes. 

21 ‘‘(37) Vibrio species (cholera). 

22 ‘‘(38) Toxoplasma gondii. 

23 ‘‘(39) Cryptosporidium parvum. 

24 ‘‘(40) Henipavirus Nipah virus (Nipa encepha25 litis). 
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1 ‘‘(41) Hantavirus spp. (Hantavirus Pulmonary 

2 Syndrome). 

3 ‘‘(42) Tickborne hemorrhagic fever viruses. 

4 ‘‘(43) Tickborne encephalitis virus. 

5 ‘‘(44) Flavivirus Yellow Fever virus (Yellow 

6 fever, West Nile virus, Dengue). 

7 ‘‘(45) Human Immunodeficiency Virus (HIV), 

8 Acquired Immune Deficiency Syndrome (AIDS) 

9 ‘‘(46) Plasmodium falciparum, P. ovale, P. 

10 vivax, P. malariae (Malaria). 

11 ‘‘(47) Rickettsia typhi (typhus). 

12 ‘‘(48) Antibiotic-resistant Mycobacterium tuber13 culosis. 

14 ‘‘(49) Entamoeba histolytica (amebiasis). 

15 ‘‘(50) Pathogenic Shigella spp. (bacillary dys16 entery, Shigellosis). 

17 ‘‘(51) Giardia lamblia (giardiasis). 

18 ‘‘(52) Orthopox virus spp. (monkey pox infec19 tion). 

20 ‘‘(53) Trypanosoma brucei gambiense or 

21 rhodesiense (trypanosomiasis, sleeping sickness). 

22 ‘‘(54) Leishmania donovane (visceral leishmani23 asis, black fever, Kala Azar). 

24 ‘‘(55) Schistosoma mansoni, S. haematobium, 

25 S. japonicum (schistosomiasis or bilharzia). 
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1 ‘‘(56) Necator Americanus and Ancylostoma 

2 duodenale (hookworm). 

3 ‘‘(57) Ascaris lumbricoides (roundworm). 

4 ‘‘(58) Trichuris trichiura (whipworm). 

5 ‘‘(59) Onchocerca volvulus (river blindness). 

6 ‘‘(60) Drancunculus medianensis (guinea 

7 worm). 

8 ‘‘(61) Wuchereria bancrofti and Brugia malayi 

9 (lymphatic filariasis or elephantiasis). 

10 ‘‘(62) Mycobacterium ulcerans (Burulu Ulcer). 

11 ‘‘(63) Mycobacterium leprea (leprosy). 

12 ‘‘(64) Chlamydia trachomitis (Trachoma). 

13 ‘‘(65) Pathogenic Streptococcus spp. 

14 ‘‘(66) Nerve agents (including Tabun, Sarin, 

15 Soman, GF, VX, V-gas, third generation nerve 

16 agents organophosphate pesticides add carbamate 

17 insecticides). 

18 ‘‘(67) Blood agents (including hydrogen cyanide 

19 and cyanogen chloride). 

20 ‘‘(68) Blister agents (including Lewisite, nitro21 gen and sulfur mustards). 

22 ‘‘(69) Heavy metals (including arsenic, lead, 

23 and mercury). 

24 ‘‘(70) Volatile toxins (including benzene, chloro25 form, and trihalomethanes). 
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1 ‘‘(71) Pulmonary agents (including phosgene 

2 and chlorine vinyl chloride). 

3 ‘‘(72) Incapacitating agents (including BZ). 

4 ‘‘(73) Nuclear and radiological materials. 

5 ‘‘(74) Exotic agents including hybrid orga6 nisms, genetically modified organisms, antibiotic-in7 duced toxins, autoimmune peptides, immune mim8 icry agents, binary bioweapons, stealth viruses, and 

9 bioregulators and biomodulators. 

10 ‘‘(75) Innovative treatments and measures to 

11 address trauma, including excessive bleeding, result12 ing from an act of terrorism. 

13 ‘‘(76) Any other new and emerging natural in14 fectious disease threats. 

15 ‘‘(g) REVISIONS.—The Secretary shall revise the list 

16 developed under subsection (f) on at least an annual basis, 

17 and make such list available, under the terms and limita18 tions described in this section, to potential manufacturers 

19 of terror weapons countermeasures, infectious disease 

20 countermeasures, or weapons of mass destruction counter21 measures, or to holders of approved certifications. Such 

22 terms and conditions shall be consistent with the security 

23 interests of the United States. 

24 ‘‘(h) NO JUDICIAL REVIEW.—Notwithstanding any 

25 other provision of law, there shall be no judicial review 
63 

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1 of the Secretary’s determinations regarding which agents, 

2 toxins, or materials to include on the list, or revised list, 

3 developed under this section or of a determination to ex4 empt information from public distribution under this sec5 tion. 

6 ‘‘(i) EXEMPTION.— 

7 ‘‘(1) IN GENERAL.—The Secretary may exempt 

8 certain information concerning weapons of mass de9 struction from publication if the Secretary deter10 mines that such publication would be detrimental to 

11 the security of the United States. In providing an 

12 exemption under the preceding sentence, the Sec13 retary shall develop procedures for making such list 

14 or information available on a confidential basis to 

15 potential manufacturers of countermeasures. 

16 ‘‘(2) SUFFICIENCY OF INFORMATION.—In devel17 oping the procedures described in paragraph (1), the 

18 Secretary shall ensure that the information provided 

19 to potential manufacturers of countermeasures is 

20 sufficient to enable the Federal Government and the 

21 manufacturer to determine when such a manufac22 turer has successfully developed a countermeasure 

23 and therefore becomes entitled to the procurement, 

24 intellectual property, and liability provisions of title 
64 

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1 III of the Project BioShield II Act of 2005 (and the 

2 amendments made by such title).’’. 

3 (b) DETECTION TECHNOLOGY INCENTIVES.—Section 

4 512 of the Homeland Security Act of 2002 (as added by 

5 section 101), is amended by— 

6 (1) redesignating subsection (b) as subsection 

7 (d); and 

8 (2) inserting after subsection (a) the following: 

9 ‘‘(b) DETECTORS TECHNOLOGY INCENTIVES.— 

10 ‘‘(1) IDENTIFICATION.— 

11 ‘‘(A) IN GENERAL.—Not later than 180 

12 days after the date of enactment of the Project 

13 BioShield II Act of 2005, the Secretary shall 

14 develop and make available to potential manu15 facturers, a list of the infectious disease, bio16 logical, chemical, radiological, or nuclear agents 

17 to be detected as well as the name and seller of 

18 the detection technology furnished to the Gov19 ernment and whether the Secretary has cer20 tified such detection technology under section 

21 301(b)(4) of the Project BioShield II Act of 

22 2005. The detection targets shall include chem23 ical or biological agents or toxins or nuclear or 

24 radiological materials. 
65 

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1 ‘‘(B) AVAILABILITY OF INFORMATION.— 

2 The Secretary shall provide such information as 

3 the Secretary determines to be necessary to en4 able the potential manufacturers of terror 

5 weapons and infectious disease detection tech6 nology to structure and focus their research and 

7 development programs for the development of 

8 such technology. 

9 ‘‘(C) REVISIONS.—The Secretary shall re10 vise the list developed under subparagraph (A) 

11 not less often than annually, and make such list 

12 available to potential manufacturers of terror 

13 weapons and infectious disease detections equip14 ment under terms and conditions consistent 

15 with the security interests of the United States. 

16 ‘‘(D) NO JUDICIAL REVIEW.—Notwith17 standing any other provision of law, there shall 

18 be no judicial review of the determinations by 

19 the Secretary regarding which agents, toxins, or 

20 materials are to be included on the list, or re21 vised list, developed under this subsection. 

22 ‘‘(E) CONSULTATION.—In developing and 

23 revising the list described under subparagraph 

24 (A), the Secretary shall consult with the Sec-
66 

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1 retary of Health and Human Services and the 

2 Secretary of Defense. 

3 ‘‘(F) EXEMPTION.— 

4 ‘‘(i) IN GENERAL.—The Secretary 

5 may exempt certain information concerning 

6 weapons of mass destruction from publica7 tion under this subsection if the Secretary 

8 determines that such publication would be 

9 detrimental to the security of the United 

10 States. In providing an exemption under 

11 the preceding sentence, the Secretary shall 

12 develop procedures for making such list or 

13 information available on a confidential 

14 basis to potential manufacturers of coun15 termeasures. 

16 ‘‘(ii) SUFFICIENCY OF INFORMA17 TION.—In developing the procedures de18 scribed in clause (i), the Secretary shall 

19 ensure that the information provided to po20 tential manufacturers of countermeasures 

21 is sufficient to enable the Federal Govern22 ment and the manufacturer to determine 

23 when such a manufacturer has successfully 

24 developed a countermeasure and therefore 

25 becomes entitled to the procurement, intel-
67 

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1 lectual property, and liability provisions of 

2 title III of the Project BioShield II Act of 

3 2005 (and the amendments made by such 

4 title). 

5 ‘‘(2) OTHER DETECTION TECHNOLOGY INCEN6 TIVES.— 

7 ‘‘(A) IN GENERAL.—In furnishing the list 

8 to potential vendors of detection technology, the 

9 Secretary shall promote the advancement of 

10 bioinformatics through the use of incentives for 

11 bioinformatics research tools to develop detec12 tion technology. 

13 ‘‘(B) COOPERATION.—The Secretary shall 

14 cooperate with the Secretary of the Department 

15 of Homeland Security and in consultation with 

16 the appropriate Advisory Committees, in the 

17 course of DHS certification of detection tech18 nology countermeasures, to generate perform19 ance measures or performance standards (such 

20 as ‘time to result’, ‘sensitivity’, or ‘specificity’ 

21 with respect to a target pathogen) for such de22 tection technology countermeasures. 

23 ‘‘(c) DECONTAMINATION TECHNOLOGY INCEN24 TIVES.— 

25 ‘‘(1) IDENTIFICATION.— 
68 

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1 ‘‘(A) IN GENERAL.—Not later than 180 

2 days after the date of enactment of the Project 

3 BioShield II Act of 2005, the Secretary shall 

4 develop and make available to potential manu5 facturers, a list of the infectious disease, bio6 logical, chemical, radiological, or nuclear agents 

7 for which decontamination technology is nec8 essary as well as the name and seller of the de9 contamination technology furnished to the Gov10 ernment and whether the Secretary has cer11 tified such decontamination technology under 

12 section 301(b)(4) of the Project BioShield II 

13 Act of 2005. The decontamination targets shall 

14 include chemical or biological agents or toxins 

15 or nuclear or radiological materials. 

16 ‘‘(B) AVAILABILITY OF INFORMATION.— 

17 The Secretary shall provide such information as 

18 the Secretary determines to be necessary to en19 able the potential manufacturers of terror 

20 weapons and infectious disease decontamination 

21 technology to structure and focus their research 

22 and development programs for the development 

23 of such technology. 

24 ‘‘(C) REVISIONS.—The Secretary shall re25 vise the list developed under subparagraph (A) 
69 

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1 not less often than annually, and make such list 

2 available to potential manufacturers of terror 

3 weapons and infectious disease decontamination 

4 equipment under terms and conditions con5 sistent with the security interests of the United 

6 States. 

7 ‘‘(D) NO JUDICIAL REVIEW.—Notwith8 standing any other provision of law, there shall 

9 be no judicial review of the determinations by 

10 the Secretary regarding which agents, toxins, or 

11 materials are to be included on the list, or re12 vised list, developed under this subsection. 

13 ‘‘(E) CONSULTATION.—In developing and 

14 revising the list described under subparagraph 

15 (A), the Secretary shall consult with the Sec16 retary of Health and Human Services and the 

17 Secretary of Defense. 

18 ‘‘(F) EXEMPTION.— 

19 ‘‘(i) IN GENERAL.—The Secretary 

20 may exempt certain information concerning 

21 weapons of mass destruction from publica22 tion under this subsection if the Secretary 

23 determines that such publication would be 

24 detrimental to the security of the United 

25 States. In providing an exemption under 
70 

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1 the preceding sentence, the Secretary shall 

2 develop procedures for making such list or 

3 information available on a confidential 

4 basis to potential manufacturers of coun5 termeasures. 

6 ‘‘(ii) SUFFICIENCY OF INFORMA7 TION.—In developing the procedures de8 scribed in clause (i), the Secretary shall 

9 ensure that the information provided to po10 tential manufacturers of countermeasures 

11 is sufficient to enable the Federal Govern12 ment and the manufacturer to determine 

13 when such a manufacturer has successfully 

14 developed a countermeasure and therefore 

15 becomes entitled to the procurement, intel16 lectual property, and liability provisions of 

17 title III of the Project BioShield II Act of 

18 2005 (and the amendments made by such 

19 title).’’. 

20 (d) NEGOTIATIONS WITH FOREIGN GOVERN21 MENTS.—The Secretary of Homeland Security shall enter 

22 into negotiations with foreign governments and organiza23 tions to secure coordination and reciprocity among the ap24 plicable regulatory agencies responsible for approving and 

25 licensing countermeasures, including diagnostics, vaccines, 
71 

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1 and drugs to prevent, treat, detect, or identify, an infec2 tious disease. 

3 SEC. 203. ANNUAL REPORT. 

4 Part B of title III of the Public Health Service Act 

5 (42 U.S.C. 243 et seq.) (as amended by sections 202, 

6 1401, 1631, 1901, 2101, and 2102) is amended by insert7 ing after section 319F–8 (as added by section 1631) the 

8 following: 

9 ‘‘SEC. 319F–9. ANNUAL REPORT. 

10 ‘‘(a) IN GENERAL.— 

11 ‘‘(1) SUBMISSION OF REPORT.—Not later than 

12 January 1, 2006, and each January 1 thereafter, 

13 the Secretary shall submit to the appropriate com14 mittees of Congress, and make available to the pub15 lic, a report concerning the implementation of sec16 tions 319F–4 through 319F–8 and the amendments 

17 made by title III of the Project BioShield II Act of 

18 2005. 

19 ‘‘(2) CONTENT OF REPORT.—Reports under 

20 paragraph (1) shall include— 

21 ‘‘(A) an assessment of whether the incen22 tives provided for under sections 319F–4 

23 through 319F–8 and such amendments are suf24 ficient, as determined by the Secretary, to in25 duce the biotechnology, pharmaceutical, device, 
72 

S 975 IS 

1 and research tool industries to modify their on2 going research priorities and devote manage3 ment and scientific talent to researching the de4 velopment of priority countermeasures, detec5 tions equipment, diagnostics, research tools, or 

6 drugs intended to directly prevent or treat the 

7 pathological and physiological effects of expo8 sures to biological, chemical, nuclear, radio9 logical, and other emerging bioterrorist threats 

10 and infectious diseases; 

11 ‘‘(B) an assessment of whether such incen12 tives are sufficient, as determined by the Sec13 retary, to address the sensitivity of such indus14 tries to the possibility of challenges to their 

15 prices and patents and the terms of sales that 

16 may arise when the Federal Government is an 

17 oligopoly or monopoly purchaser; 

18 ‘‘(C) an assessment of whether such incen19 tives are likely to lead to the development of 

20 countermeasures and implementation through 

21 the qualified clinical countermeasures delivery 

22 centers to prepare the United States in the 

23 event of the use by terrorists and others of bio24 logical, chemical, nuclear, or radiological weap25 ons against military or intelligence, Govern-
73 

S 975 IS 

1 ment, and civilian population of the United 

2 States; 

3 ‘‘(D) an assessment of whether such incen4 tives will lead to the development of research 

5 tools; 

6 ‘‘(E) an assessment of whether such provi7 sions are achieving the goal of securing the 

8 United States from bioterror attacks and infec9 tious disease outbreaks; 

10 ‘‘(F) an assessment of whether the 

11 incentivies of the Project BioShield II Act of 

12 2005 are being abused by sponsors seeking ex13 panded market protection for non-counter14 measure products based on the development of 

15 countermeasures that are marginally useful or 

16 that require minimal research and development 

17 efforts; 

18 ‘‘(G) an accounting of the additional 

19 healthcare costs to consumers, healthcare pro20 viders, and government payors due to the appli21 cation of the marketing protection incentivies of 

22 such Act; 

23 ‘‘(H) a description of how such incentives 

24 for private sector research relate to the provi-
74 

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1 sion of public funding for the development of 

2 countermeasures; and 

3 ‘‘(I) recommendations to increase or de4 crease the effectiveness of such incentives. 

5 ‘‘(b) LIMITATION ON PUBLICATION.—The Secretary 

6 may exempt information from disclosure to the public 

7 under subsection (a) if the Secretary determines that such 

8 publication may be detrimental to the security of the 

9 United States. Such determinations by the Secretary shall 

10 not be subject to judicial review.’’. 

11 SEC. 204. USE OF FUNDS; REQUIREMENTS OF MANUFAC12 TURERS. 

13 (a) IN GENERAL.—The Secretary of Health and 

14 Human Services may use funds appropriated for the Stra15 tegic National Stockpile under section 319F–2 of the Pub16 lic Health Service Act (42 U.S.C. 247d–6b) or under any 

17 other provision of law for the storage, maintenance, secu18 rity, rotation, and transport of any material purchased for 

19 such stockpile. 

20 (b) REQUIREMENTS OF MANUFACTURERS.—The Sec21 retary of Health and Humans Services shall provide to 

22 manufacturers, to the extent practicable, the logistical and 

23 operational requirements of countermeasures prior to their 

24 development and acquisition. The logistical and oper25 ational requirements shall consider public health needs as 
75 

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1 well as requirements for storage, maintenance, security, 

2 rotation, and transport of any countermeasures purchased 

3 under the authority of the Project BioShield Act of 2004. 

4 TITLE III—AMENDMENTS TO 

5 THE PROJECT BIOSHIELD 

6 ACT OF 2004 REGARDING IN7 CENTIVES TO ESTABLISH BIO8 DEFENSE, INFECTIOUS DIS9 EASE, VACCINE, AND RE10 SEARCH TOOL INDUSTRIES 

11 Subtitle A—Certification of 

12 Successful Development 

13 SEC. 301. CERTIFICATION OF SUCCESSFUL DEVELOPMENT. 

14 (a) DEFINITIONS.—For purposes of this title, the 

15 term ‘‘countermeasure’’ has the meaning given that term 

16 in section 319F–3 of the Public Health Service Act (as 

17 added by section 101), and the terms ‘‘countermeasure 

18 product’’, ‘‘eligible patent’’ and ‘‘designated product’’ have 

19 the meanings given such terms in section 156(a) of title 

20 35, United States Code (as added by section 331). 

21 (b) CERTIFICATION REQUIREMENTS.— 

22 (1) IN GENERAL.—An entity described in para23 graph (2) may submit to the Secretary of Health 

24 and Human Services (referred to in this subtitle as 

25 the ‘‘Secretary’’) with respect to agreements for pro-
76 

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1 curement entered into under section 319F–1 or 

2 319F–2 of the Public Health Service Act (42 U.S.C. 

3 247d–6a or 247d–6b), or to the Secretary of Home4 land Security with respect to agreements for pro5 curement entered into under section 512 of the 

6 Homeland Security Act of 2002 (as added by section 

7 202), an application for certification that— 

8 (A) the entity may receive a patent term 

9 extension under the provisions of section 158 of 

10 title 35, United States Code (as added by sec11 tion 331), and the duration of any such exten12 sion; and 

13 (B) the entity has successfully developed a 

14 countermeasure under an agreement described 

15 in paragraph (2)(C). 

16 (2) ENTITY DESCRIBED.—An entity described 

17 under this paragraph is an entity that— 

18 (A) operates a private sector establish19 ment; 

20 (B) is engaged in the conduct of research 

21 to develop a countermeasure; and 

22 (C) enters into an agreement for procure23 ment with the Secretary under the authority 

24 provided in section 319F–1 or 319F–2 of the 

25 Public Health Service Act (42 U.S.C. 247d–6a 
77 

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1 or 247d–6b), or with the Secretary of Home2 land Security under section 512 of the Home3 land Security Act of 2002 (as added by section 

4 101). 

5 (3) SUCCESSFUL DEVELOPMENT OF A COUN6 TERMEASURE.—For the purposes of this section, an 

7 entity shall be deemed to have successfully developed 

8 a countermeasure if, after the date the entity enters 

9 into an agreement for procurement with the Sec10 retary under the authority provided in section 

11 319F–1 or 319F–2 of the Public Health Service Act 

12 (42 U.S.C. 247d–6a or 247d–6b), or with the Sec13 retary of Homeland Security under section 512 of 

14 the Homeland Security Act of 2002 as added by sec15 tion 101, either— 

16 (A) the entity has met the requirements 

17 specified in the contract for procurement under 

18 section 319F–1 or 319F–2 of the Public Health 

19 Service Act (42 U.S.C. 247d–6a or 247d–6b)) 

20 or under section 512 of the Homeland Security 

21 Act of 2002; or 

22 (B) the countermeasure has been approved 

23 under sections 505 or 513 of the Federal Food 

24 Drug and Cosmetic Act (21 U.S.C. 355) or sec-
78 

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1 tion 351 of the Public Health Service Act; (42 

2 U.S.C. 262), as appropriate. 

3 (4) CERTIFICATIONS BY SECRETARY.— 

4 (A) CERTIFICATION AS TO ELIGIBILITY

5 FOR SPECIAL PATENT TERM EXTENSION.— 

6 (i) IN GENERAL.—An entity, prior to 

7 the date it has successfully developed a 

8 countermeasure product, may request that 

9 the Secretary determine if the entity is en10 titled to receive an extension of the term of 

11 an eligible patent under section 158 of title 

12 35, United States Code (as added by sec13 tion 331), and the duration of any such ex14 tension. 

15 (ii) FACTORS CONSIDERED.—The Sec16 retary shall consider the following factors 

17 in making the determinations specified in 

18 clause (i)— 

19 (I) the nature of the terror 

20 threats to be countered and the im21 portance of developing the counter22 measures in question to respond to 

23 such threat; 
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1 (II) the difficulty, risk, and ex2 pense likely to be associated with the 

3 development of such countermeasure; 

4 (III) the existence or non-exist5 ence of practical alternatives to the 

6 countermeasure to be developed; 

7 (IV) whether review of the safety 

8 and effectiveness of the counter9 measure product will require reports 

10 from clinical investigations of the 

11 countermeasure product; and 

12 (V) the impact of the patent ex13 tension on consumers and healthcare 

14 providers. 

15 (iii) LIMITATION.—The Secretary may 

16 determine that an extension under this sec17 tion is available only if the countermeasure 

18 product involved— 

19 (I) contains an active ingredient 

20 (including any ester or salt of the ac21 tive ingredient) which has not been 

22 approved in another application under 

23 section 505(b) of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 

25 355(b)); and 
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1 (II) is superior to a previously 

2 available drug, antibiotic drug, bio3 logical product, device, detection tech4 nology, or research tool. 

5 (iv) LIMITATION ON EXTENSIONS.— 

6 Any extension authorized by the Secretary 

7 shall not exceed 2 years, and shall not be 

8 less than 6 months, in duration. 

9 (v) WRITTEN DETERMINATION.—The 

10 Secretary shall provide an entity that re11 quests a determination under clause (i) 

12 with a written determination on the eligi13 bility of that entity for a patent term ex14 tension under section 158 of title 35, 

15 United States Code (as added by section 

16 331), and the duration of any such exten17 sion. 

18 (vi) EFFECT OF SECTION.—The Sec19 retary shall promulgate regulations to give 

20 effect to this section. 

21 (B) WRITTEN NOTICE OF ENTITY DEVEL22 OPING COUNTERMEASURE.— 

23 (i) IN GENERAL.—Not later than 180 

24 days after entering a contract with the 

25 Secretary of Health and Human Services 
81 

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1 under section 319F–1 or 319F–2 of the 

2 Public Health Service Act (42 U.S.C. 

3 247d–6a or 247d–6b) or with the Sec4 retary of Homeland Security under section 

5 512 of the Homeland Security Act of 2002 

6 (as added by section 101) for the procure7 ment of a countermeasure for which the 

8 Secretary of Health and Human Services 

9 or the Secretary of Homeland Security, as 

10 appropriate, has determined that a patent 

11 extension is available under section 158 of 

12 title 35, United States Code (as added by 

13 section 331), the entity that enters such 

14 contract shall notify such appropriate Sec15 retary of the patent that would be ex16 tended if such entity received a certifi17 cation under section 301(b)(4)(A). 

18 (ii) PUBLICATION OF INFORMATION.— 

19 The Secretary of Health and Human Serv20 ices, with respect to a contract under such 

21 section 319F–1 or 319F–2 of the Public 

22 Health Service Act, or the Secretary of 

23 Homeland Security, with respect to a con24 tract under such section 512 of the Home25 land Security Act of 2002, shall publish in 
82 

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1 the Federal Register the information pro2 vided in a notification received under 

3 clause (i). 

4 (iii) IRREVOCABLE ELECTION.—An 

5 submission of a notification by an entity 

6 under clause (i) shall constitute an irrev7 ocable election of the patent extended 

8 under section 158 of title 35, United 

9 States Code, except that such entity may 

10 elect to restore the term of the eligible pat11 ent under section 156a of title 35, United 

12 States Code, instead of extending the term 

13 of the patent under such section 158 on 

14 the basis of the successful development of 

15 the countermeasure. 

16 (C) CERTIFICATION AS TO SUCCESSFUL

17 DEVELOPMENT.—With respect to an application 

18 for certification submitted by an entity in ac19 cordance with the terms of the agreement for 

20 procurement described under paragraph (2)(C), 

21 the Secretary or the Secretary of Homeland Se22 curity, as appropriate, shall— 

23 (i) determine if the entity has success24 fully developed the countermeasure in25 volved; 
83 

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1 (ii) provide the notice required under 

2 subparagraph (B); 

3 (iii) approve or deny the application 

4 for certification; and 

5 (iv) notify such entity of and publish 

6 such approval or denial, and the reasons 

7 therefore. 

8 (D) EFFECTS OF CERTIFICATION.—If the 

9 Secretary or Secretary of Homeland Security 

10 certifies the application of an entity under para11 graph (3)(A), such entity— 

12 (i) shall receive payment under the 

13 contract described in paragraph (2)(C); 

14 (ii) may utilize the patent restoration 

15 and extension protection under section 

16 156a and 158 of title 35, United States 

17 Code (as added by section 331); 

18 (iii) may utilize the marketing exclu19 sivity provisions of section 505(c)(3)(E) 

20 and 505(j)(5)(F) of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 

22 355(c)(3)(E) and 21 U.S.C. 355(j)(5)(E)); 

23 and 
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1 (iv) may utilize the liability protec2 tions described under this title (and the 

3 amendments made by this title). 

4 (c) RULE OF CONSTRUCTION.—Nothing in this sec5 tion shall be construed to restrict the authority of the Sec6 retary (with respect to procurement agreements under sec7 tion 319F–1 or 319F–2 of the Public Health Service Act 

8 (42 U.S.C. 247d–6a or 247d–6b)) or the Secretary of 

9 Homeland Security (with respect to procurement agree10 ments under section 512 of the Homeland Security Act 

11 of 2002 (as added by section 101) to permit an entity to 

12 utilize the liability protections described under this title 

13 (and the amendments made by this title) or to receive pay14 ment under the agreement described in subsection 

15 (b)(2)(C) prior to the approval of the application for cer16 tification submitted by the entity pursuant to the terms 

17 of such agreement. 

18 (d) JUDICIAL REVIEW.—A determination by the Sec19 retary or the Secretary of Homeland Security, as appro20 priate, under subsection (b) shall constitute final agency 

21 action subject to judicial review. A prevailing plaintiff in 

22 an action challenging an adverse determination by the 

23 Secretary or Secretary of Homeland Security under such 

24 subsection may be awarded reasonable attorneys fees 

25 under section 2412 of title 28, United States Code. 
85 

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1 Subtitle B—Federal Tax Incentives 

2 SEC. 311. GENERAL PROVISIONS. 

3 (a) IN GENERAL.—Any entity which enters into a 

4 contract for procurement with the Secretary under the au5 thority provided in section 319F–1 or 319F–2 of the Pub6 lic Health Service Act (42 U.S.C. 247d–6a or 247d–6b) 

7 or under section 512 of the Homeland Security Act of 

8 2002 (as added by section 101) may irrevocably elect 1 

9 of the following Federal tax incentives to fund research 

10 with respect to each contract to develop countermeasures 

11 (as that term is defined in section 319F–3 of the Public 

12 Health Service Act (as added by section 202)): 

13 (1) RESEARCH AND DEVELOPMENT LIMITED

14 PARTNERSHIPS TO FUND COUNTERMEASURE RE15 SEARCH.—The entity may establish a limited part16 nership for the countermeasures, but only if such en17 tity is a qualified small business as determined 

18 under section 1202(d) of the Internal Revenue Code 

19 of 1986, by substituting ‘‘$750,000,000’’ for 

20 ‘‘$50,000,000’’ each place it appears. For purposes 

21 of the Internal Revenue Code of 1986, section 469 

22 of such Code shall not apply with respect to a lim23 ited partnership established under this paragraph. 

24 (2) CAPITAL GAINS EXCLUSION FOR INVESTORS

25 TO FUND COUNTERMEASURE RESEARCH.—The enti-
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1 ty may issue a class of stock for the counter2 measures under section 1202 of the Internal Rev3 enue Code of 1986 with the following modifications: 

4 (A) INCREASED EXCLUSION FOR NONCOR5 PORATE TAXPAYERS.—Subsection (a) of section 

6 1202 of such Code shall be applied by sub7 stituting ‘‘100 percent’’ for ‘‘50 percent’’. 

8 (B) APPLICATION TO CORPORATE TAX9 PAYERS.—Subsection (a) of section 1202 of 

10 such Code shall be applied without regard to 

11 the phrase ‘‘other than a corporation’’. 

12 (C) STOCK OF LARGER BUSINESSES ELIGI13 BLE FOR EXCLUSION.—Paragraph (1) of sec14 tion 1202(d) of such Code (defining qualified 

15 small business) shall be applied by substituting 

16 ‘‘$750,000,000’’ for ‘‘$50,000,000’’ each place 

17 it appears. 

18 (D) REDUCTION IN HOLDING PERIOD.— 

19 Subsection (a) of section 1202 of such Code 

20 shall be applied by substituting ‘‘3 years’’ for 

21 ‘‘5 years’’. 

22 (E) NONAPPLICATION OF PER-ISSUER LIM23 ITATION.—Section 1202 of such Code shall be 

24 applied without regard to subsection (b) (relat-
87 

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1 ing to per-issuer limitations on taxpayer’s eligi2 ble gain). 

3 (F) MODIFICATION OF WORKING CAPITAL

4 LIMITATION.—Section 1202(e)(6) of such Code 

5 shall be applied— 

6 (i) in subparagraph (B), by sub7 stituting ‘‘5 years’’ for ‘‘2 years’’, and 

8 (ii) without regard to the last sen9 tence. 

10 (G) NONAPPLICATION OF MINIMUM TAX

11 PREFERENCE.—Section 57(a) of such Code 

12 shall be applied without regard to paragraph 

13 (7). 

14 (3) TAX CREDITS TO FUND COUNTERMEASURE

15 RESEARCH.—The entity may be eligible for the tax 

16 credits provided for in section 312. 

17 (b) REPORTING; RECAPTURE.— 

18 (1) REPORTING.—Each entity described in sub19 section (a) shall submit to the Secretary and the 

20 Secretary of the Treasury such information regard21 ing its election of any tax incentive under this sec22 tion with respect to any contract described in sub23 section (a) as the Director of the National Institutes 

24 of Health and the Secretary of Health and Human 

25 Services determine necessary to carry out the en-
88 

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1 forcement provisions prescribed under paragraph 

2 (2). 

3 (2) RECAPTURE.—The Secretary of the Treas4 ury, in consultation with the Director of the Na5 tional Institutes of Health and the Secretary of 

6 Health and Human Services, shall provide for the 

7 recapture of any tax benefits resulting from any 

8 elected tax incentive under this section if the result9 ing research is for a purpose other than that speci10 fied in such contract. 

11 (c) EFFECTIVE DATE.—The provisions of this section 

12 shall apply to taxable years beginning after December 31, 

13 2004. 

14 SEC. 312. TAX CREDITS. 

15 (a) AMENDMENTS TO THE INTERNAL REVENUE

16 CODE.— 

17 (1) TAX CREDIT TO FUND COUNTERMEASURE

18 RESEARCH.— 

19 (A) IN GENERAL.—Subpart D of part IV 

20 of subchapter A of chapter 1 of the Internal 

21 Revenue Code of 1986 (relating to business-re22 lated credits) is amended by adding at the end 

23 the following new section: 
89 

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1 ‘‘SEC. 45J. CREDIT FOR MEDICAL RESEARCH RELATED TO 

2 DEVELOPING COUNTERMEASURES. 

3 ‘‘(a) GENERAL RULE.—For purposes of section 38, 

4 in the case of any entity described in section 311(a) of 

5 the Project BioShield II Act of 2005 which makes an elec6 tion under such section to apply this section, the counter7 measures research credit determined under this section for 

8 the taxable year is an amount equal to 35 percent of the 

9 eligible countermeasures research expenses for the taxable 

10 year. 

11 ‘‘(b) ELIGIBLE COUNTERMEASURES RESEARCH EX12 PENSES.—For purposes of this section— 

13 ‘‘(1) ELIGIBLE COUNTERMEASURES RESEARCH

14 EXPENSES.— 

15 ‘‘(A) IN GENERAL.—Except as otherwise 

16 provided in this paragraph, the term ‘eligible 

17 countermeasures research expenses’ means the 

18 amounts which are paid or incurred by the tax19 payer during the taxable year with respect to 

20 any contract described in section 311(a) of the 

21 Project BioShield II Act of 2005 which would 

22 be described in subsection (b) of section 41 if 

23 such subsection were applied with the modifica24 tions set forth in subparagraph (B). 

25 ‘‘(B) MODIFICATIONS; INCREASED INCEN26 TIVE FOR CONTRACT RESEARCH PAYMENTS.— 
90 

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1 For purposes of subparagraph (A), subsection 

2 (b) of section 41 shall be applied— 

3 ‘‘(i) by substituting ‘eligible counter4 measures research’ for ‘qualified research’ 

5 each place it appears in paragraphs (2) 

6 and (3) of such subsection, and 

7 ‘‘(ii) by substituting ‘100 percent’ for 

8 ‘65 percent’ in paragraph (3)(A) of such 

9 subsection. 

10 ‘‘(C) EXCLUSION FOR AMOUNTS FUNDED

11 BY GRANTS, ETC.—The term ‘eligible counter12 measures research expenses’ shall not include 

13 any amount to the extent such amount is fund14 ed by any grant, contract, or otherwise by an15 other person (or any governmental entity). 

16 ‘‘(2) COUNTERMEASURES RESEARCH.—The 

17 term ‘countermeasures research’ means research 

18 conducted by an entity with respect to the develop19 ment of countermeasures (as defined in section 

20 319F–3 of the Public Health Service Act). 

21 ‘‘(c) COORDINATION WITH CREDIT FOR INCREASING

22 RESEARCH EXPENDITURES.— 

23 ‘‘(1) IN GENERAL.—Except as provided in para24 graph (2), any eligible countermeasures research ex25 penses for a taxable year to which an election under 
91 

S 975 IS 

1 this section applies shall not be taken into account 

2 for purposes of determining the credit allowable 

3 under section 41 for such taxable year. 

4 ‘‘(2) EXPENSES INCLUDED IN DETERMINING

5 BASE PERIOD RESEARCH EXPENSES.—Any eligible 

6 countermeasures research expenses for any taxable 

7 year which are qualified research expenses (within 

8 the meaning of section 41(b)) shall be taken into ac9 count in determining base period research expenses 

10 for purposes of applying section 41 to subsequent 

11 taxable years. 

12 ‘‘(d) COORDINATION WITH CREDIT FOR CLINICAL

13 TESTING EXPENSES FOR CERTAIN DRUGS FOR RARE

14 DISEASES.—Any eligible countermeasures research ex15 pense for a taxable year shall not be taken into account 

16 for purposes of determining the credit allowable under sec17 tion 45C for such taxable year. 

18 ‘‘(e) SPECIAL RULES.— 

19 ‘‘(1) PRE-CLINICAL RESEARCH.—No credit shall 

20 be allowed under this section for pre-clinical re21 search unless such research is pursuant to a re22 search plan an abstract of which has been filed with 

23 the Food and Drug Administration before the begin24 ning of such year. This paragraph shall be waived 

25 for any research that is pursuant to a research plan 
92 

S 975 IS 

1 or abstract that has been filed with the Food and 

2 Drug Administration not later than 270 days after 

3 the date of enactment of this section. The Secretary 

4 of Health and Human Services shall prescribe regu5 lations specifying the requirements for such plans 

6 and procedures for filing under this paragraph. 

7 ‘‘(2) CERTAIN RULES MADE APPLICABLE.— 

8 Rules similar to the rules of paragraphs (1) and (2) 

9 of section 41(f) shall apply for purposes of this sec10 tion.’’. 

11 (B) INCLUSION IN GENERAL BUSINESS

12 CREDIT.—Section 38(b) of such Code is amend13 ed by striking ‘‘plus’’ at the end of paragraph 

14 (18), by striking the period at the end of para15 graph (19) and inserting ‘‘, plus’’, and by add16 ing at the end the following new paragraph: 

17 ‘‘(20) the countermeasures research credit de18 termined under section 45J.’’. 

19 (C) DENIAL OF DOUBLE BENEFIT.—Sec20 tion 280C of such Code is amended by adding 

21 at the end the following new subsection: 

22 ‘‘(e) CREDIT FOR ELIGIBLE COUNTERMEASURES RE23 SEARCH EXPENSES.— 

24 ‘‘(1) IN GENERAL.—No deduction shall be al25 lowed for that portion of the eligible counter-
93 

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1 measures research expenses (as defined in section 

2 45J(b)) otherwise allowable as a deduction for the 

3 taxable year which is equal to the amount of the 

4 credit determined for such taxable year under sec5 tion 45J(a). 

6 ‘‘(2) CERTAIN RULES TO APPLY.—Rules similar 

7 to the rules of paragraphs (2), (3), and (4) of sub8 section (c) shall apply for purposes of this sub9 section.’’. 

10 (D) DEDUCTION FOR UNUSED PORTION OF

11 CREDIT.—Section 196(c) of such Code (defining 

12 qualified business credits) is amended by strik13 ing ‘‘and’’ at the end of paragraph (11), by 

14 striking the period at the end of paragraph (12) 

15 and inserting ‘‘, and’’, and by adding at the end 

16 the following new paragraph: 

17 ‘‘(13) the countermeasures research credit de18 termined under section 45J(a) (other than such 

19 credit determined under the rules of section 

20 280C(e)(2)).’’. 

21 (E) TECHNICAL AMENDMENT.—The table 

22 of sections for subpart D of part IV of sub23 chapter A of chapter 1 of such Code is amended 

24 by adding at the end the following new item: 

‘‘Sec. 45J. Credit for medical research related to developing countermeasures.’’. 
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1 (2) TAX CREDIT TO FUND COUNTERMEASURE

2 RESEARCH AT CERTAIN QUALIFIED NON-PROFIT AND

3 ACADEMIC INSTITUTIONS INCLUDING TEACHING

4 HOSPITALS.— 

5 (A) IN GENERAL.—Subpart D of part IV 

6 of subchapter A of chapter 1 of the Internal 

7 Revenue Code of 1986 (relating to business re8 lated credits) is amended by inserting after sec9 tion 41 the following: 

10 ‘‘SEC. 41A. CREDIT FOR COUNTERMEASURES RESEARCH 

11 EXPENSES. 

12 ‘‘(a) GENERAL RULE.—For purposes of section 38, 

13 in the case of any entity described in section 311(a) of 

14 the Project BioShield II Act of 2005 which makes an elec15 tion under such section to apply this section, the counter16 measures research credit determined under this section for 

17 the taxable year shall be an amount equal to 35 percent 

18 of the excess (if any) of— 

19 ‘‘(1) the eligible countermeasures research ex20 penses for the taxable year, over 

21 ‘‘(2) the countermeasures base period amount. 

22 ‘‘(b) ELIGIBLE COUNTERMEASURES RESEARCH EX23 PENSES.—For purposes of this section— 

24 ‘‘(1) IN GENERAL.—The term ‘eligible counter25 measures research expenses’ means the amounts 
95 

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1 which are paid or incurred by the taxpayer during 

2 the taxable year directly or indirectly to any quali3 fied nonprofit or academic institution for counter4 measures research activities with respect to any con5 tract described in section 311(a) of the Project Bio6 Shield II Act of 2005. 

7 ‘‘(2) COUNTERMEASURES RESEARCH ACTIVI8 TIES.— 

9 ‘‘(A) IN GENERAL.—The term ‘counter10 measures research activities’ means research 

11 conducted by an entity with respect to the de12 velopment of countermeasures (as defined in 

13 section 319F–3 of the Public Health Service 

14 Act), conducted at any qualified nonprofit or 

15 academic institution in the development of any 

16 product, which occurs before— 

17 ‘‘(i) the date on which an application 

18 with respect to such product is approved 

19 under section 505(b), 506, or 507 of the 

20 Federal Food, Drug, and Cosmetic Act, 

21 ‘‘(ii) the date on which a license for 

22 such product is issued under section 351 of 

23 the Public Health Service Act, or 

24 ‘‘(iii) the date classification or ap25 proval of such product which is a device in-
96 

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1 tended for human use is given under sec2 tion 513, 514, or 515 of the Federal Food, 

3 Drug, and Cosmetic Act. 

4 ‘‘(B) PRODUCT.—The term ‘product’ 

5 means any drug, biologic, medical device, or re6 search tool. 

7 ‘‘(3) QUALIFIED NONPROFIT OR ACADEMIC IN8 STITUTION.—The term ‘qualified nonprofit or aca9 demic institution’ means any of the following institu10 tions: 

11 ‘‘(A) EDUCATIONAL INSTITUTION.—A 

12 qualified organization described in section 

13 170(b)(1)(A)(iii) which is owned or affiliated 

14 with an institution of higher education as de15 scribed in section 3304(f). 

16 ‘‘(B) TEACHING HOSPITAL.—A teaching 

17 hospital which— 

18 ‘‘(i) is publicly supported or owned by 

19 an organization described in section 

20 501(c)(3), and 

21 ‘‘(ii) is affiliated with an organization 

22 meeting the requirements of subparagraph 

23 (A). 

24 ‘‘(C) FOUNDATION.—A medical research 

25 organization described in section 501(c)(3) 
97 

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1 (other than a private foundation) which is affili2 ated with, or owned by— 

3 ‘‘(i) an organization meeting the re4 quirements of subparagraph (A), or 

5 ‘‘(ii) a teaching hospital meeting the 

6 requirements of subparagraph (B). 

7 ‘‘(D) CHARITABLE RESEARCH HOS8 PITAL.—A hospital that is designated as a can9 cer center by the National Cancer Institute. 

10 ‘‘(E) OTHER INSTITUTIONS.—A qualified 

11 organization (as defined in section 41(e)(6)). 

12 ‘‘(4) EXCLUSION FOR AMOUNTS FUNDED BY

13 GRANTS, ETC.—The term ‘eligible countermeasures 

14 research expenses’ shall not include any amount to 

15 the extent such amount is funded by any grant, con16 tract, or otherwise by another person (or any gov17 ernmental entity). 

18 ‘‘(c) COUNTERMEASURES RESEARCH BASE PERIOD

19 AMOUNT.—For purposes of this section, the term ‘coun20 termeasures research base period amount’ means the aver21 age annual eligible countermeasures research expenses 

22 paid by the taxpayer during the 3-taxable year period end23 ing with the taxable year immediately preceding the first 

24 taxable year of the taxpayer beginning after December 31, 

25 2004. 
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1 ‘‘(d) SPECIAL RULES.— 

2 ‘‘(1) CERTAIN RULES MADE APPLICABLE.— 

3 Rules similar to the rules of subsections (f) and (g) 

4 of section 41 shall apply for purposes of this section. 

5 ‘‘(2) COORDINATION WITH CREDIT FOR IN6 CREASING RESEARCH EXPENDITURES AND WITH

7 CREDIT FOR CLINICAL TESTING EXPENSES FOR CER8 TAIN DRUGS FOR RARE DISEASES.—Any eligible 

9 countermeasures research expense for a taxable year 

10 shall not be taken into account for purposes of de11 termining the credit allowable under section 41 or 

12 45C for such taxable year. 

13 ‘‘(3) ELIGIBLE COUNTERMEASURES RESEARCH

14 EXPENSES NOT TREATED AS UNRELATED BUSINESS

15 TAXABLE INCOME.—For purposes of section 511, el16 igible countermeasures research expenses paid or in17 curred by the taxpayer directly or indirectly to any 

18 qualified non-profit or academic institution shall not 

19 be considered unrelated business taxable income of 

20 such institution.’’. 

21 (B) CREDIT TO BE PART OF GENERAL

22 BUSINESS CREDIT.—Section 38(b) of such Code 

23 (relating to current year business credits), as 

24 amended by this section, is amended by striking 

25 ‘‘plus’’ at the end of paragraph (19), by strik-
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1 ing the period at the end of paragraph (20) and 

2 inserting ‘‘, plus’’, and by adding at the end the 

3 following: 

4 ‘‘(21) the countermeasures research credit de5 termined under section 41A(a).’’. 

6 (C) DENIAL OF DOUBLE BENEFIT.—Sec7 tion 280C of such Code, as amended by this 

8 section, is amended by adding at the end the 

9 following new subsection: 

10 ‘‘(f) CREDIT FOR COUNTERMEASURES RESEARCH

11 EXPENSES.— 

12 ‘‘(1) IN GENERAL.—No deduction shall be al13 lowed for that portion of the eligible counter14 measures research expenses (as defined in section 

15 41A(b)) otherwise allowable as a deduction for the 

16 taxable year which is equal to the amount of the 

17 credit determined for such taxable year under sec18 tion 41A(a). 

19 ‘‘(2) CERTAIN RULES TO APPLY.—Rules similar 

20 to the rules of paragraphs (2), (3), and (4) of sub21 section (c) shall apply for purposes of this sub22 section.’’. 

23 (D) DEDUCTION FOR UNUSED PORTION OF

24 CREDIT.—Section 196(c) of such Code (defining 

25 qualified business credits), as amended by this 
100 

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1 section, is amended by striking ‘‘and’’ at the 

2 end of paragraph (12), by striking the period at 

3 the end of paragraph (13) and inserting ‘‘, 

4 and’’, and by adding at the end the following 

5 new paragraph: 

6 ‘‘(14) the countermeasures research expenses 

7 credit determined under section 41A(a) (other than 

8 such credit determined under the rules of section 

9 280C(f)(2)),’’. 

10 (E) CLERICAL AMENDMENT.—The table of 

11 sections for subpart D of part IV of subchapter 

12 A of chapter 1 of such Code is amended by 

13 adding after the item relating to section 41 the 

14 following: 

‘‘Sec. 41A. Credit for countermeasures research expenses.’’. 

15 (3) COUNTERMEASURES EQUITY TAX CREDIT.— 

16 (A) IN GENERAL.—Subpart D of part IV 

17 of subchapter A of chapter 1 of the Internal 

18 Revenue Code of 1986 (relating to business-re19 lated credits), as amended by this section, is 

20 amended by adding at the end the following 

21 new section: 

22 ‘‘SEC. 45K. COUNTERMEASURES EQUITY TAX CREDIT. 

23 ‘‘(a) ALLOWANCE OF CREDIT.— 

24 ‘‘(1) GENERAL RULE.—For purposes of section 

25 38, in the case of a taxpayer who holds a qualified 
101 

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1 countermeasures equity investment on a credit allow2 ance date of such investment which occurs during 

3 the taxable year, the countermeasures equity tax 

4 credit determined under this section for such taxable 

5 year is an amount equal to the applicable percentage 

6 of the amount paid to the qualified countermeasures 

7 company solely in exchange for its stock at original 

8 issue. 

9 ‘‘(2) APPLICABLE PERCENTAGE.—For purposes 

10 of paragraph (1), the applicable percentage is 40 

11 percent. 

12 ‘‘(3) CREDIT ALLOWANCE DATE.—For purposes 

13 of paragraph (1), the term ‘credit allowance date’ 

14 means, with respect to any qualified counter15 measures equity investment— 

16 ‘‘(A) the date on which such investment is 

17 initially made, and 

18 ‘‘(B) each of the 3 anniversary dates of 

19 such date thereafter. 

20 ‘‘(b) QUALIFIED COUNTERMEASURES EQUITY IN21 VESTMENT.—For purposes of this section— 

22 ‘‘(1) IN GENERAL.—The term ‘qualified coun23 termeasures equity investment’ means any equity in24 vestment in a qualified countermeasures company 

25 if— 
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1 ‘‘(A) such investment is acquired by the 

2 taxpayer at its original issue (directly or 

3 through an underwriter) solely in exchange for 

4 cash, 

‘‘(B) not less than 1 5 ⁄2 of such cash is used 

6 by the qualified countermeasures company with 

7 respect to any contract described in section 

8 311(a) of the Project BioShield II Act of 2005 

9 or efforts reasonably leading to such contract 

10 (such as generation of preliminary data or pro11 totype development), and 

12 ‘‘(C) such investment is designated for 

13 purposes of this section by the qualified coun14 termeasures company. 

15 Such term shall not include any equity investment 

16 issued by a qualified countermeasures company more 

17 than 5 years after the date that such company re18 ceives an allocation under subsection (d). Any alloca19 tion not used within such 5-year period may be re20 allocated by the Secretary under subsection (d). 

21 ‘‘(2) LIMITATION.—The maximum amount of 

22 equity investments issued by a qualified counter23 measures company which may be designated under 

24 paragraph (1)(C) by such company shall not exceed 
103 

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1 the portion of the limitation amount allocated under 

2 subsection (f) to such company. 

3 ‘‘(3) TREATMENT OF SUBSEQUENT PUR4 CHASERS.—The term ‘qualified equity investment’ 

5 includes any equity investment which would (but for 

6 paragraph (1)(A)) be a qualified equity investment 

7 in the hands of the taxpayer if such investment was 

8 a qualified equity investment in the hands of a prior 

9 holder. 

10 ‘‘(4) REDEMPTIONS.—A rule similar to the rule 

11 of section 1202(c)(3) shall apply for purposes of this 

12 subsection. 

13 ‘‘(5) EQUITY INVESTMENT.—The term ‘equity 

14 investment’ means any stock (other than non15 qualified preferred stock as defined in section 

16 351(g)(2)) in an entity which is a corporation. 

17 ‘‘(c) QUALIFIED COUNTERMEASURES COMPANY.— 

18 For purposes of this section the term ‘qualified counter19 measures company’ means any domestic corporation sub20 ject to tax under subchapter C of this chapter if such com21 pany has entered into a procurement contract with the 

22 Secretary of Health and Human Services under section 

23 319F–1 or 319F–2 of the Public Health Service Act (42 

24 U.S.C. 247d–6a or 247d–6b) or with the Secretary of 
104 

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1 Homeland Security under section 512 of the Homeland 

2 Security Act of 2002. 

3 ‘‘(d) NATIONAL LIMITATION ON AMOUNT OF INVEST4 MENTS DESIGNATED.— 

5 ‘‘(1) IN GENERAL.—There is a qualified coun6 termeasures equity tax credit limitation for each cal7 endar year. Such limitation is $100,000,000 for each 

8 calendar year 2005 through 2009. 

9 ‘‘(2) ALLOCATION OF LIMITATION.—The limita10 tion under paragraph (1) shall be allocated by the 

11 Secretary among qualified countermeasures compa12 nies selected by the Secretary. In making allocations 

13 under the preceding sentence, the Secretary shall 

14 give priority to the extent to which it is reasonably 

15 anticipated that a qualified countermeasures com16 pany would have insufficient taxable income and tax 

17 liability to utilize research tax credits and other tax 

18 incentives provided by sections 311 and 312 of the 

19 Project BioShield II Act of 2005. 

20 ‘‘(3) CARRYOVER OF UNUSED LIMITATION.—If 

21 the qualified countermeasures equity tax credit limi22 tation for any calendar year exceeds the aggregate 

23 amount allocated under paragraph (2) for such year, 

24 such limitation for the succeeding calendar year 

25 shall be increased by the amount of such excess. No 
105 

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1 amount may be carried under the preceding sentence 

2 to any calendar year after 2014. 

3 ‘‘(e) RECAPTURE OF CREDIT IN CERTAIN CASES.— 

4 ‘‘(1) IN GENERAL.—If, at any time during the 

5 4-year period beginning on the date of the original 

6 issue of a qualified countermeasures equity invest7 ment in a qualified countermeasures company, there 

8 is a recapture event with respect to such investment, 

9 then the tax imposed by this chapter for the taxable 

10 year in which such event occurs shall be increased 

11 by the credit recapture amount. 

12 ‘‘(2) CREDIT RECAPTURE AMOUNT.—For pur13 poses of paragraph (1), the credit recapture amount 

14 is an amount equal to the sum of— 

15 ‘‘(A) the aggregate decrease in the credits 

16 allowed to the taxpayer under section 38 for all 

17 prior taxable years which would have resulted if 

18 no credit had been determined under this sec19 tion with respect to such investment, plus 

20 ‘‘(B) interest at the underpayment rate es21 tablished under section 6621 on the amount de22 termined under subparagraph (A) for each 

23 prior taxable year for the period beginning on 

24 the due date for filing the return for the prior 

25 taxable year involved. 
106 

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1 No deduction shall be allowed under this chapter for 

2 interest described in subparagraph (B). 

3 ‘‘(3) RECAPTURE EVENT.—For purposes of 

4 paragraph (1), there is a recapture event with re5 spect to a qualified countermeasures equity invest6 ment in a qualified countermeasures company if— 

7 ‘‘(A) such company ceases to be a qualified 

8 countermeasures company, or 

9 ‘‘(B) such investment is redeemed by such 

10 company. 

11 ‘‘(4) SPECIAL RULES.— 

12 ‘‘(A) TAX BENEFIT RULE.—The tax for 

13 the taxable year shall be increased under para14 graph (1) only with respect to credits allowed 

15 by reason of this section which were used to re16 duce tax liability. In the case of credits not so 

17 used to reduce tax liability, the carryforwards 

18 and carrybacks under section 39 shall be appro19 priately adjusted. 

20 ‘‘(B) NO CREDITS AGAINST TAX.—Any in21 crease in tax under this subsection shall not be 

22 treated as a tax imposed by this chapter for 

23 purposes of determining the amount of any 

24 credit under this chapter or for purposes of sec25 tion 55. 
107 

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1 ‘‘(f) BASIS REDUCTION.—The basis of any qualified 

2 countermeasures equity investment shall be reduced by the 

3 amount of any credit determined under this section with 

4 respect to such investment. This subsection shall not apply 

5 for purposes of sections 1202, 1400B, and 1400F. 

6 ‘‘(g) REGULATIONS.—The Secretary shall prescribe 

7 such regulations as may be appropriate to carry out this 

8 section, including regulations which— 

9 ‘‘(1) prevent the abuse of the purposes of this 

10 section, 

11 ‘‘(2) impose appropriate reporting require12 ments, and 

13 ‘‘(3) apply the provisions of this section to 

14 newly formed entities.’’. 

15 (B) CREDIT TO BE PART OF GENERAL

16 BUSINESS CREDIT.—Section 38(b) of such Code 

17 (relating to current year business credits), as 

18 amended by this section, is amended by striking 

19 ‘‘plus’’ at the end of paragraph (20), by strik20 ing the period at the end of paragraph (21) and 

21 inserting ‘‘, plus’’, and by adding at the end the 

22 following: 

23 ‘‘(22) the countermeasures equity investment 

24 credit determined under section 45K(a).’’. 
108 

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1 (C) DEDUCTION FOR UNUSED PORTION OF

2 CREDIT.—Section 196(c) of such Code (defining 

3 qualified business credits), as amended by this 

4 section, is amended by striking ‘‘and’’ at the 

5 end of paragraph (13), by striking the period at 

6 the end of paragraph (14) and inserting ‘‘, 

7 and’’, and by adding at the end the following 

8 new paragraph: 

9 ‘‘(15) the countermeasures equity investment 

10 credit determined under section 45K(a),’’. 

11 (D) CLERICAL AMENDMENT.—The table of 

12 sections for subpart D of part IV of subchapter 

13 A of chapter 1 of such Code is amended by 

14 adding after the item relating to section 41 the 

15 following: 

‘‘Sec. 45K. Countermeasures equity tax credit.’’. 

16 (b) EFFECTIVE DATE.—The amendments made by 

17 this section shall apply to taxable years beginning after 

18 December 31, 2004. 

19 Subtitle C—Patent Protections 

20 SEC. 331. PATENT TERM RESTORATION AND EXTENSION 

21 AND EXCLUSIVE MARKETING. 

22 (a) LIMITATION.—A private entity may utilize the 

23 patent term restoration and extension and exclusive mar24 keting provisions described in this subtitle if such private 

25 entity— 
109 

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1 (1) is an entity described under section 

2 301(b)(2); 

3 (2) has had an application for certification ap4 proved by the Secretary of Health and Human Serv5 ices or the Secretary of Homeland Security, as ap6 propriate, under section 301(b)(4)(C); and 

7 (3)(A) has received approval of the counter8 measure by the Food and Drug Administration; or 

9 (B) section 319F–2(e) applies. 

10 (b) RESTORATION OF PATENT TERMS RELATING TO

11 COUNTERMEASURES.— 

12 (1) IN GENERAL.—Chapter 14 of title 35, 

13 United States Code, is amended by inserting after 

14 section 156 the following: 

15 ‘‘§ 156a. Restoration of patent terms relating to coun16 termeasure products 

17 ‘‘(a) DEFINITIONS.—In this section, the term— 

18 ‘‘(1) ‘countermeasure product’ means a counter19 measure, as that term is defined in section 319F– 

20 3(a)(2) of the Public Health Service Act, that is a— 

21 ‘‘(A) new drug, antibiotic drug, or device, 

22 as those terms are defined in section 201 of the 

23 Federal Food, Drug, and Cosmetic Act (21 

24 U.S.C. 321); or 
110 

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1 ‘‘(B) biological product, as such term is 

2 defined in section 351 of the Public Health 

3 Service Act (42 U.S.C. 262); 

4 ‘‘(2) ‘regulatory review period’ means the period 

5 of time that— 

6 ‘‘(A) starts on the date that is the later 

7 of— 

8 ‘‘(i) the date that an eligible patent 

9 sought to be extended under this section is 

10 filed; 

11 ‘‘(ii) if the countermeasure product is 

12 a drug, antibiotic drug, or biological prod13 uct, the date that an exemption under sec14 tion 505(i) of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 355(i)) became 

16 effective for the product; or 

17 ‘‘(iii) if the countermeasure product is 

18 a device, the date that an investigational 

19 device exception is approved under section 

20 520(g) of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 360j(g)) became 

22 effective for the product; and 

23 ‘‘(B) ends on the date that is— 

24 ‘‘(i) in the case of a drug or antibiotic 

25 drug, the date on which an application 
111 

S 975 IS 

1 submitted for the drug or antibiotic drug 

2 under section 505(b)(1) of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 

4 355(b)(1)) is approved; 

5 ‘‘(ii) in the case of a biological prod6 uct, the date on which an application sub7 mitted for the biological product under sec8 tion 351 of the Public Health Service Act 

9 (42 U.S.C. 262) is approved; 

10 ‘‘(iii) in the case of a device, the date 

11 on which an application submitted for the 

12 device under section 513 of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 

14 360c) is approved; or 

15 ‘‘(iv) if an application is submitted 

16 under subsection (c)(3) prior to any of the 

17 dates specified in clauses (i) through (iii), 

18 the date that the countermeasure product 

19 became eligible for purchase under a con20 tract for procurement under section 319F– 

21 1 or 319F–2 of the Public Health Service 

22 Act (42 U.S.C. 247d–6a or 247d–6b)) or 

23 under section 512 of the Homeland Secu24 rity Act of 2002; 

25 ‘‘(3) ‘eligible patent’ means a patent that— 
112 

S 975 IS 

1 ‘‘(A) claims a countermeasure product that 

2 has been successfully developed as specified in 

3 section 301(b)(3) of the Research Act, or an ac4 tive ingredient of such product, or a process of 

5 making or method of using such product or the 

6 active ingredient of such product for the coun7 termeasure use that has been approved by the 

8 Food and Drug Administration; and 

9 ‘‘(B) is owned by, or licensed to, an entity 

10 that has been certified as having successfully 

11 developed the countermeasure section 

12 301(b)(4)(C) of the Research Act; and 

13 ‘‘(4) ‘Research Act’ means the Project Bio14 Shield II Act of 2005. 

15 ‘‘(b) PATENT TERM RESTORATION.—The term of an 

16 eligible patent shall be restored by a period equal to the 

17 number of days in the regulatory review period if, with 

18 respect to the patent that is the basis of the application— 

19 ‘‘(1) an application under subsection (c) is sub20 mitted to the Director by either the owner of record 

21 of the patent, or its agent, on or before the later 

22 of— 

23 ‘‘(A) the date specified in subsection 

24 (c)(3); or 
113 

S 975 IS 

1 ‘‘(B) 45 days after the date of issuance of 

2 the patent; 

3 ‘‘(2) the patent has not been previously restored 

4 under this section, or extended under section 156 or 

5 158; 

6 ‘‘(3) the term of the patent has not expired be7 fore the date that the application is submitted to the 

8 Director; and 

9 ‘‘(4) the regulatory review period for the coun10 termeasure product— 

11 ‘‘(A) has not been relied upon to support 

12 an application to extend the term of another 

13 patent under this section or under section 156; 

14 and 

15 ‘‘(B) did not commence before the date of 

16 enactment of the Research Act. 

17 ‘‘(c) ADMINISTRATIVE PROVISIONS.— 

18 ‘‘(1) IN GENERAL.—To obtain a restoration of 

19 the term of a patent under this section, the owner 

20 of record of the patent or the agent of the owner 

21 shall submit an application to the Director. 

22 ‘‘(2) CONTENT.—The application shall con23 tain— 
114 

S 975 IS 

1 ‘‘(A) a description of the approved counter2 measure product and the Federal statute under 

3 which regulatory review occurred; 

4 ‘‘(B) the identity of the patent for which 

5 a restoration is sought; and 

6 ‘‘(C) such other information as the Direc7 tor may require. 

8 ‘‘(3) SUBMISSION OF APPLICATION.—An appli9 cation under this section shall be submitted to the 

10 Director not later than 60 days after the last of the 

11 following dates: 

12 ‘‘(A) The date that the product became eli13 gible for purchase under a contract for procure14 ment under section 319F–1 or 319F–2 of the 

15 Public Health Service Act (42 U.S.C. 247d–6a 

16 or 247d–6b)) or under section 512 of the 

17 Homeland Security Act of 2002. 

18 ‘‘(B) The date that an application under 

19 section 505 of the Federal Food Drug and Cos20 metic Act was approved for the drug or anti21 biotic drug. 

22 ‘‘(C) The date that an application under 

23 section 351 of the Public Health Service Act 

24 was approved for the biological product. 
115 

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1 ‘‘(D) The date that an application under 

2 section 513 of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 360c) was approved 

4 for the device. 

5 ‘‘(4) PUBLICATION OF APPLICATIONS BY THE

6 SECRETARY.—Immediately under receipt of an appli7 cation for patent restoration under this subsection, 

8 the Director shall publish the application and pro9 vide a reasonable period of time for interested par10 ties to submit comments with respect to the applica11 tion. 

12 ‘‘(5) IRREVOCABLE ELECTION.—The submis13 sion of an application under this section is an irrev14 ocable election of the application of this section to 

15 the patent that is the basis of the application. A pat16 ent that has been the basis of an application made 

17 under this section may not be the subject of an ap18 plication made under section 156 or 158. 

19 ‘‘(d) LIMITATIONS.—A patent that is the subject of 

20 an application filed under subsection (c) may not be re21 stored under this section if— 

22 ‘‘(1) the regulatory review period for the coun23 termeasure product was commenced before the date 

24 of enactment of the Research Act; 
116 

S 975 IS 

1 ‘‘(2) the patent that is the basis of the applica2 tion under this section expired before the date of en3 actment of the Research Act; or 

4 ‘‘(3) a patent which has been extended under 

5 section 156 of this title prior to the date of enact6 ment of the Research Act claims the countermeasure 

7 product, an active ingredient of the countermeasure 

8 product, a method of using the countermeasure 

9 product, a method of using an active ingredient of 

10 the countermeasure product, or making the counter11 measure.’’. 

12 (2) TECHNICAL AND CONFORMING AMEND13 MENT.—The table of sections for chapter 14 of title 

14 35, United States Code, is amended by inserting 

15 after the item relating to section 156 the following: 

‘‘156a. Restoration of patent terms relating to countermeasure products.’’. 

16 (c) EXTENSION OF PATENT TERMS RELATING TO

17 COUNTERMEASURE PRODUCTS.— 

18 (1) IN GENERAL.—Chapter 14 of title 35, 

19 United States Code, is amended by adding at the 

20 end the following: 

21 ‘‘§ 158. Extension of patent terms relating to counter22 measure products 

23 ‘‘(a) DEFINITIONS.—In this section, the term— 
117 

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1 ‘‘(1) ‘countermeasure product’ means a counter2 measure, as that term is defined in 319F–3(a)(2) of 

3 the Public Health Service Act, that is a— 

4 ‘‘(A) new drug or antibiotic drug, as those 

5 terms are defined in section 201 in the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 

7 321), containing an active ingredient (including 

8 any ester or salt of the active ingredient) which 

9 has not been approved in another application 

10 under section 505(b) of that Act (21 U.S.C. 

11 355(b)); 

12 ‘‘(B) device, as that term is defined in sec13 tion 201 in the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 321); or 

15 ‘‘(C) biological product, as that term is de16 fined in section 351 of the Public Health Serv17 ice Act (42 U.S.C. 262); 

18 ‘‘(2) ‘designated product’ means a drug, anti19 biotic drug, or device, as those terms are defined in 

20 section 201 of the Federal Food, Drug and Cosmetic 

21 Act (21 U.S.C. 321), or a biological product, as that 

22 term is defined in section 351 of the Public Health 

23 Service Act; 

24 ‘‘(3) ‘eligible patent’ means a patent that at the 

25 time the eligible entity entered into the contract to 
118 

S 975 IS 

1 develop such countermeasure product, was owned by 

2 or licensed to that eligible entity, and claims a des3 ignated product, an active ingredient of a designated 

4 product, a method of making or using a designated 

5 product or a method of making or using an active 

6 ingredient of a designated product; 

7 ‘‘(4) ‘eligible entity’ means a natural or legal 

8 person that has— 

9 ‘‘(A) successfully developed a counter10 measure product; 

11 ‘‘(B) been certified as being eligible to re12 ceive a patent term extension under this section 

13 by section 301(b)(4)(A)(i) of the Research Act; 

14 ‘‘(C) been certified as having successfully 

15 developed a countermeasure under section 

16 301(b)(4)(C) of the Research Act; and 

17 ‘‘(D) entered into a contract for the sale of 

18 the countermeasure product under section 

19 319F–1 or 319F–2 of the Public Health Serv20 ice Act (42 U.S.C. 247d–6a or 247d–6b) or sec21 tion 512 of the Homeland Security Act of 2002; 

22 and 

23 ‘‘(5) ‘Research Act’ means the Project Bio24 Shield II Act of 2005. 
119 

S 975 IS 

1 ‘‘(b) PATENT TERM EXTENSION.—The term of an el2 igible patent shall be extended for the period determined 

3 by the Secretary of Health and Human Services in a cer4 tification under section 301(b)(4)(A)(i) of the Research 

5 Act, in addition to the term which would otherwise apply 

6 except for this section, if— 

7 ‘‘(1) an application under subsection (c) is sub8 mitted to the Director by either the owner of record 

9 of the patent or its agent on or before the date spec10 ified in subsection (c)(3); 

11 ‘‘(2) the patent has not been previously ex12 tended under this section, or under section 156 or 

13 156a; 

14 ‘‘(3) the applicant has provided written notice 

15 and the Secretary has published such information as 

16 required under section 301(b)(4)(B) of the Project 

17 BioShield II Act of 2005; 

18 ‘‘(4) the patent has not expired before the date 

19 that the application is submitted; 

20 ‘‘(5) the term of no other patent has been ex21 tended based on the certification being relied upon 

22 by the eligible entity to request extension of the pat23 ent; and 

24 ‘‘(6) no other patent that claims the designated 

25 product, an active ingredient of the designated prod-
120 

S 975 IS 

1 uct, a method of making or using a designated prod2 uct or a method of making or using an active ingre3 dient of a designated product has been extended 

4 under this section or under section 156a. 

5 ‘‘(c) ADMINISTRATIVE PROVISIONS.— 

6 ‘‘(1) IN GENERAL.—To obtain an extension of 

7 the term of a patent under this section, the owner 

8 of record of the patent or the agent of the owner 

9 shall submit an application to the Director. 

10 ‘‘(2) CONTENT.—An application filed under this 

11 section shall contain— 

12 ‘‘(A) a description of the approved counter13 measure product and the Federal statute under 

14 which regulatory review occurred; 

15 ‘‘(B) the identity of the eligible patent for 

16 which an extension is sought under this section; 

17 ‘‘(C) the identity of the eligible entity and 

18 the applicant (if different from the eligible enti19 ty); 

20 ‘‘(D) the identity of the designated product 

21 to which the eligible patent relates; 

22 ‘‘(E) information concerning the certifi23 cation specified in section 301(b)(4)(A)(i) of the 

24 Research Act being relied upon as the basis of 

25 the extension being requested; 
121 

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1 ‘‘(F) information indicating that the entity 

2 owned or licensed the eligible patent at the time 

3 it entered into the contract to develop the 

4 countermeaure product; and 

5 ‘‘(G) such other information as the Direc6 tor may require including to establish that the 

7 applicant meets the requirements of this sec8 tion. 

9 ‘‘(3) SUBMISSION OF APPLICATION.—An appli10 cation under this section shall be submitted to the 

11 Director within 60 days after the date of the certifi12 cation specified in section 301(b)(4)(C) of the Re13 search Act that is being relied upon to request ex14 tension of the patent that is the subject of the appli15 cation. 

16 ‘‘(d) IRREVOCABLE ELECTION.—The submission of 

17 an application under this section is an irrevocable election 

18 of the application of this section to the patent that is the 

19 basis of the application. A patent that has been the basis 

20 of an application made under this section may not be the 

21 subject of an application made under sections 156 or 

22 156a.’’. 

23 (2) TECHNICAL AND CONFORMING AMEND24 MENT.—The table of sections for chapter 14 of title 
122 

S 975 IS 

1 35, United States Code, is amended by adding at 

2 the end the following: 

‘‘158. Extension of patent terms relating to countermeasure products.’’. 

3 (d) DISCRETIONARY WAIVER OF MARCH-IN RIGHTS

4 AND EXCLUSIVE LICENSING.— 

5 (1) DISCRETION TO WAIVE MARCH-IN

6 RIGHTS.— 

7 (A) IN GENERAL.—The owner of a patent 

8 over which the Government has rights under 

9 chapter 18 of title 35, United States Code, may 

10 request that a Federal agency under whose 

11 funding a subject invention was made may 

12 waive rights the Government has under sections 

13 200, 203, and 209 of title 35, United States 

14 Code, if— 

15 (i) such entity holds a certification 

16 under section 301(b)(4)(C) of the Research 

17 Act; and 

18 (ii) the subject invention is related to 

19 or will be used to discover, evaluate, 

20 produce, manufacture or use the counter21 measure, detection equipment, diagnostic, 

22 research tool, drug, antibiotic drug, biologi23 cal product or a device that is the subject 

24 of the certification. 
123 

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1 (B) REQUESTS.—If a request under sub2 paragraph (A) is made within 90 days after the 

3 date of the certification under section 

4 301(b)(4)(C) of the Research Act or the date 

5 that the entity obtained title to the patent, the 

6 Federal agency shall grant the request. 

7 (2) FEDERALLY OWNED INVENTIONS.—Section 

8 209 of title 35, United States Code, is amended— 

9 (A) by redesignating subsections (e) and 

10 (f) as subsections (f) and (g), respectively; and 

11 (B) by inserting after subsection (d) the 

12 following: 

13 ‘‘(e) TERMS AND CONDITIONS OF EXCLUSIVE LI14 CENSE.—Each exclusive license granted under section 

15 207(a)(2) shall include a provision that, at the discretion 

16 of the licensee, the licensee may act as the agent for the 

17 licensor with respect to any patent for the licensed inven18 tion for purposes of extending a patent under section 156a 

19 or 158.’’. 

20 (3) COOPERATIVE RESEARCH AND DEVELOP21 MENT AGREEMENTS.—Section 12(b) of the Steven22 son-Wydler Technology Innovation Act of 1980 (15 

23 U.S.C. 3710a(b)) is amended by adding at the end 

24 the following: 
124 

S 975 IS 

1 ‘‘(7) Each exclusive license for a patent granted 

2 under an agreement entered into under subsection 

3 (a)(1) shall include a provision that, at the discre4 tion of the licensee, the licensee may act as the 

5 agent for the licensor with respect to that patent for 

6 purposes of extending a patent under section 156a 

7 or 158 of title 35, United States Code.’’. 

8 (4) APPLICABLE LICENSES.—The amendments 

9 made by paragraphs (2) and (3) shall apply only to 

10 exclusive licenses granted after 60 days after the 

11 date of enactment of this Act. 

12 (e) EXCLUSIVE MARKETING.—Subchapter A of chap13 ter V of the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 351 et seq.) is amended by inserting after section 

15 505B, the following: 

16 ‘‘SEC. 505C. MARKET EXCLUSIVITY FOR COUNTERMEASURE 

17 PRODUCTS. 

18 ‘‘(a) IN GENERAL.—Subsection (b) shall apply if the 

19 Secretary determines that a new drug is a countermeasure 

20 product, as that term is defined in section 156a(a)(1) of 

21 title 35, United States Code, that has been successfully 

22 developed by an entity that has been certified under sec23 tion 301(b)(4)(A) of the Project BioShield II Act of 2005. 

24 ‘‘(b) EXCLUSIVITY.—With respect to a new drug de25 scribed in subsection (a)— 
125 

S 975 IS 

1 ‘‘(1)(A)(i) the period referred to in subsection 

2 (c)(3)(E)(ii) of section 505, and in subsection 

3 (j)(5)(F)(ii) of such section, shall be 10 years in4 stead of 5 years, and the periods of 4 years, to 48 

5 months, and to 7 and one-half years referred to in 

6 subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such 

7 section shall be 9 years, 108 months, and 9 years, 

8 respectively; or 

9 ‘‘(ii) the period referred to in clauses (iii) and 

10 (iv) of subsection (c)(3)(E) of such section, and in 

11 clauses (iii) and (iv) of subsection (j)(5)(F) of such 

12 section, shall be 6 years instead of 3 years; and 

13 ‘‘(B) if the drug is designated under section 

14 526 for a rare disease or condition, the period re15 ferred to in section 527(a) shall be 10 years instead 

16 of 7 years. 

17 ‘‘(c) SPECIAL RULE FOR UNEXPLOITED COUNTER18 MEASURES.—If, as of the date that is 45 days before the 

19 date on which the periods specified in paragraph (1) or 

20 (2) of section 505B expire, there has been no substantial 

21 commercial exploitation of the drug, including insubstan22 tial sales of the drug following its approval for marketing, 

23 the periods specified in such sections shall be extended by 

24 a period of 3 years.’’. 
126 

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1 SEC. 332. INTERNATIONAL PROTECTION FOR BIOSHIELD 

2 INTELLECTUAL PROPERTY. 

3 The Secretary of Commerce, the United States Trade 

4 Representative, and the Commissioner of Patents shall en5 sure in international, bilateral, and multilateral negotia6 tions and agreements, and proceedings before agencies of 

7 the World Trade Organization, that— 

8 (1) intellectual property for which restoration of 

9 a patent term is granted under section 156a of title 

10 35, United States Code (as added by section 331), 

11 or for which an extension of a patent term is grant12 ed under section 158 of title 35, United States Code, 

13 (as added by section 331) under this Act is not im14 paired; 

15 (2) substantially similar intellectual property 

16 rights granted to the same or related entities as 

17 those that qualify for restoration or an extension 

18 under such sections are not impaired; and 

19 (3) vigorous enforcement actions and sanctions 

20 are taken and imposed with respect to infringement 

21 of such intellectual property. 
127 

S 975 IS 

1 Subtitle D—Liability Protections 

2 SEC. 341. LIABILITY AND COMPENSATION FOR INJURED 

3 PARTIES. 

4 (a) THE PUBLIC HEALTH SERVICE ACT AMEND5 MENTS.—Section 224 of the Public Health Service Act 

6 (42 U.S.C. 233) is amended— 

7 (1) in subsection (a), by inserting ‘‘or the man8 ufacture or distribution of a covered countermeasure 

9 as defined in subsection (p)’’ after ‘‘including the 

10 conduct of clinical studies or investigation’’; 

11 (2) in the heading of subsection (p), by striking 

12 ‘‘ADMINISTRATION OF SMALLPOX COUNTER13 MEASURES BY HEALTH PROFESSIONALS’’ and in14 serting ‘‘MANUFACTURE, DISTRIBUTION, AND AD15 MINISTRATION OF COVERED COUNTERMEASURES’’; 

16 (3) in subsection (p)(1)— 

17 (A) by inserting ‘‘manufacture, distribu18 tion, or’’ after ‘‘liability arising out of’’; 

19 (B) by striking ‘‘against smallpox to an in20 dividual’’; and 

21 (C) by inserting before the period at the 

22 end ‘‘notwithstanding the applicability of the 

23 SAFETY Act (6 U.S.C. 441 et seq.)’’; 

24 (4) in subsection (p)(2)— 
128 

S 975 IS 

1 (A) in the heading, by striking ‘‘COUNTER2 MEASURE AGAINST SMALLPOX’’ and inserting 

3 ‘‘COVERED COUNTERMEASURES’’; 

4 (B) in subparagraph (A)(i)— 

5 (i) by inserting ‘‘(I)’’ after ‘‘makes 

6 advisable’’; and 

7 (ii) by inserting before the period at 

8 the end ‘‘; or (II) the manufacture or dis9 tribution of a covered countermeasure for 

10 possible future administration to a cat11 egory or categories of individuals’’; 

12 (C) in subparagraph (A)(ii) by inserting— 

13 (i) ‘‘, or product or products’’ after 

14 ‘‘or substances’’; and 

15 (ii) before the period at the end ‘‘and 

16 any conditions governing the manufacture 

17 or distribution of such covered counter18 measures’’; 

19 (D) in subparagraph (A)(iv), by adding at 

20 the end before the period ‘‘. Notwithstanding 

21 clause (iii), such declaration or amendment 

22 shall take effect immediately upon publication 

23 and shall not be subject to the provisions of sec24 tion 553 of title 5, United States code, con-
129 

S 975 IS 

1 cerning prior notice and opportunity for com2 ment’’. 

3 (E) in subparagraph (A), by adding at the 

4 end the following: 

5 ‘‘(v) RECOMMENDED DECLARATION.—Any 

6 person may recommend to the Secretary at any 

7 time the declaration of a countermeasure under 

8 this paragraph and may provide data and infor9 mation to support such recommendation.’’; 

10 (F) in subparagraph (B)(i), by striking ‘‘, 

11 for a purpose stated in paragraph (7)(A)(i),’’; 

12 and 

13 (G) by adding at the end the following: 

14 ‘‘(E) LIABILITY OF THE UNITED

15 STATES.—The United States shall be liable 

16 under this subsection with respect to a claim 

17 arising out of the manufacture, distribution, or 

18 administration of a covered countermeasure re19 gardless of whether— 

20 ‘‘(i) the cause of action seeking com21 pensation for harm caused by such coun22 termeasure is alleged as negligence, strict 

23 liability, breach of warranty, failure to 

24 warn, or other action; or 
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1 ‘‘(ii) the covered countermeasure is 

2 designated or certified as a qualified anti3 terrorism technology under the SAFETY 

4 Act (6 U.S.C. 441 et seq.). 

5 The United States shall be liable under this 

6 subsection for claims for injury or loss arising 

7 out of administration of a covered 

8 countermeausre during a human clinical inves9 tigation on a covered countermeasure whether 

10 or not the certification for successful develop11 ment of the countermeausre is made under sec12 tion 301(b)(3) of the Project BioShield II Act 

13 of 2005. 

14 ‘‘(F) LIABILITY OF THE UNITED STATES

15 FOR MANUFACTURE OR DISTRIBUTION WITHIN

16 THE SCOPE OF DECLARATION.— 

17 ‘‘(i) IN GENERAL.—Except as pro18 vided in paragraph (5)(B)(ii), the United 

19 States shall be liable under this subsection 

20 with respect to a claim arising out of the 

21 manufacture or distribution of a covered 

22 countermeasure if— 

23 ‘‘(I) the manufacturer was cov24 ered by a declaration by the Secretary 
131 

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1 under subparagraph (A) with respect 

2 to such countermeasure; and 

3 ‘‘(II) the countermeasure was 

4 manufactured and distributed in ac5 cordance with, and during, the rel6 evant period of such declaration. 

7 ‘‘(ii) EFFECT OF SECTION.—For pur8 poses of this section, any activity reason9 ably related to the manufacture, distribu10 tion, or administration of a covered coun11 termeasure shall be considered to be a 

12 medical, surgical, dental, or related func13 tion within the scope of the covered per14 son’s employment by the Public Health 

15 Service.’’; 

16 (5) in subsection (p)(4)(A), by inserting ‘‘man17 ufacture, distribution, or’’ after ‘‘arising out of the’’; 

18 and 

19 (6) in subsection (p)(7)— 

20 (A) by striking subparagraph (A) and in21 serting the following: 

22 ‘‘(A) COVERED COUNTERMEASURE.— 

23 ‘‘(i) BEFORE PUBLICATION OF

24 LIST.—Until the date that the Secretary 

25 publishes the list described under section 
132 

S 975 IS 

1 319F–3(f), the term ‘‘covered counter2 measure’’ means a substance or product 

3 that is specified in a declaration under 

4 paragraph (2). 

5 ‘‘(ii) After publication of list. After 

6 the date that the Secretary publishes the 

7 list described under section 319F–3(f), the 

8 term ‘‘covered countermeasure’’ means a 

9 substance or product that is— 

10 ‘‘(I) specified in a declaration 

11 under paragraph (2); and 

12 ‘‘(II)(aa) a countermeasure, as 

13 such term is defined is section 319F– 

14 3; or 

15 ‘‘(bb) designed, developed, modi16 fied, used, or procured for the purpose 

17 of preventing, detecting, identifying, 

18 or treating pandemic influenza or lim19 iting the harm such influenza might 

20 otherwise cause.’’; 

21 (B) in subparagraph (B)— 

22 (i) in the matter preceding clause (i), 

23 by inserting ‘‘manufacture, distribution, 

24 or’’ after ‘‘with respect to the’’; and 
133 

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1 (ii) in clause (iv), by inserting ‘‘or dis2 tribution’’ after ‘‘with respect to adminis3 tration’’; and 

4 (C) in subparagraph (D)— 

5 (i) in the heading, by inserting ‘‘MAN6 UFACTURE, DISTRIBUTION, OR’’ after 

7 ‘‘ARISING OUT OF’’; 

8 (ii) in the matter preceding clause (i) 

9 by— 

10 (I) striking ‘‘administration of a 

11 covered countermeasure’’; and 

12 (II) by inserting ‘‘relating to the 

13 manufacture, distribution, or adminis14 tration of a covered countermeasure’’ 

15 after ‘‘with respect to a claim or li16 ability’’; 

17 (iii) in clause (iii), by striking ‘‘; or’’ 

18 and inserting a semicolon; 

19 (iv) in clause (iv) by striking the pe20 riod and inserting ‘‘; or’’; and 

21 (v) by adding at the end the following: 

22 ‘‘(v) the manufacture or distribution 

23 of a covered countermeasure and adminis24 tration of a covered countermeasure in the 

25 course of a human clinical investigation. 
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1 For purposes of this subsection, the term 

2 ‘administration’ includes administration in 

3 the course of a human clinical investiga4 tion.’’. 

5 (b) AMENDMENTS TO THE SAFETY ACT.—The 

6 SAFETY Act (6 U.S.C. 441 et seq.) is amended— 

7 (1) in section 863, in subsections (a)(1), (a)(2), 

8 (d)(1), and (d)(2), by inserting ‘‘, or potential threat 

9 of such act,’’ after ‘‘from such act’’; 

10 (2) in section 864— 

11 (A) in subsections (a)(1), (b), and (c), by 

12 inserting ‘‘or potential threat of such act’’ after 

13 ‘‘from such act’’; and 

14 (B) in subsection (a)(3), by inserting ‘‘or 

15 potential threat of such act’’ after ‘‘act of ter16 rorism’’; and 

17 (3) in section 865(1)— 

18 (A) by inserting ‘‘(including a vaccine, 

19 therapeutic or other biological product, drug, 

20 antimicrobial or combination thereof, detection 

21 technology, or device)’’ after ‘‘product’’; 

22 (B) by inserting ‘‘, biotechnology, detection 

23 technology, or a pharmacological product’’ after 

24 ‘‘information technology’’; and 
135 

S 975 IS 

1 (C) by inserting ‘‘treating,’’ after ‘‘pre2 venting,’’. 

3 (c) LIMITATION.—A private entity may utilize the li4 ability protections described in this section (and the 

5 amendments made by this section) if such entity— 

6 (1)(A) is described under section 301(b)(2); 

7 and 

8 (B) has been certified by the Secretary of 

9 Health and Human Services or the Secretary of 

10 Homeland Security, as appropriate, under section 

11 301(b)(4); or 

12 (2) without regard to the requirements of sec13 tions 301(b)(2) and 301(b)(4), has developed a 

14 product (including a drug, vaccine, or other bio15 logic), equipment, service (including support service), 

16 device, or technology (including information tech17 nology) designed, developed, modified, used, or pro18 cured for the specific purpose of preventing, detect19 ing, identifying, or treating pandemic influenza or 

20 limiting the harm such pandemic might cause. 

21 (d) EFFECT OF SECTION.—Notwithstanding any 

22 other provision of law, an entity shall not be required to 

23 apply for and receive designation or certification by the 

24 Secretary of Homeland Security of a product or service 

25 as a Qualified Anti-Terror Technology under the SAFE-
136 

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1 TY Act (6 U.S.C. 441 et seq.) in order to receive indem2 nification under Public Law 85–804. 

3 (e) EFFECT ON PENDING ACTIONS.—Nothing in this 

4 Act (or the amendments made by this Act) shall be con5 strued to apply to a legal action pending or filed on or 

6 before the date of enactment of this Act against a manu7 facturer or other entity with respect to a diagnostic, thera8 peutic, detection technology, or research that was not con9 ducted pursuant to a contract under the amendments 

10 made by this Act or the Project BioShield Act of 2004 

11 (Public Law 108–276). 

12 TITLE IV—VALLEY OF DEATH 

13 FOR SMALL COMPANIES 

14 SEC. 401. PURPOSE. 

15 It is the purpose of this title to enable small compa16 nies to fund the initial research and development nec17 essary so that such small companies may be able to par18 ticipate in the procurement process for countermeasures, 

19 and become part of a national biodefense, infectious dis20 ease, and research tool industry. 

21 SEC. 402. VALLEY OF DEATH FOR SMALL COMPANIES. 

22 Section 319F–2 of the Public Health Service Act (42 

23 U.S.C. 247d–6b), as amended by section 103, is amended 

24 by— 
137 

S 975 IS 

1 (1) redesignating subsections (l) and (m) as 

2 subsections (r) and (s), respectively; and 

3 (2) inserting after subsection (k) the following: 

4 ‘‘(l) REIMBURSEMENT.—The Secretary may reim5 burse an entity for costs associated with improvement, in6 crease, or production of a countermeasure necessary for 

7 testing (including a clinical trial) conducted on humans 

8 or animals from funds appropriated to fund the Project 

9 BioShield Act of 2004 and the Project BioShield II Act 

10 of 2005. 

11 ‘‘(m) GRANTS TO CERTAIN ENTITIES.—The Sec12 retary may award grants to State or local government 

13 agencies, small businesses, university technology partner14 ship offices, and other entities to conduct preliminary 

15 screening of compounds and to develop of business plans 

16 related to such preliminary screenings. 

17 ‘‘(n) SECURITY FUNDING.—The Secretary shall pro18 vide funding for an entity that enters into an agreement 

19 under the amendments made by the Project BioShield Act 

20 of 2004 or the Project BioShield II Act of 2005 (and the 

21 amendments made by such Act) to provide security for 

22 the personnel and facilities of such entity that develop, 

23 produce, distribute, or store countermeasures under sec24 tion 319K. 
138 

S 975 IS 

1 ‘‘(o) PRIORITY ACCESS TO CERTAIN RESEARCH RE2 SULTS.—An entity that enters into an agreement under 

3 this section, section 319F–2, or section 512 of the Home4 land Security Act of 2002 shall be given priority access 

5 to the results of research related to the epidemiology and 

6 pathogenesis of agents, the genomes and other DNA anal7 ysis, or other comparative analysis of agents relevant to 

8 research conducted under subparagraphs (A), (B), and 

9 (C) of section 319F(h)(1). 

10 ‘‘(p) TRANSLATIONAL DEVELOPMENT FOR BIO11 DEFENSE DRUG AND VACCINE CANDIDATES.— 

12 ‘‘(1) IN GENERAL.—An entity that enters into 

13 an agreement under this section, section 319F–2, or 

14 section 512 of the Homeland Security Act of 2002 

15 shall be eligible for translational development for 

16 biodefense drug and infectious disease counter17 measure candidates. For purposes of this section, 

18 such entities may include universities, small busi19 nesses, for-profit, and nonprofit entities. 

20 ‘‘(2) TRANSLATIONAL DEVELOPMENT.—In this 

21 subsection, the term ‘translational development’ 

22 shall include the following: 

23 ‘‘(A) Triage screening of applications for 

24 promising drug and biological candidates. 
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S 975 IS 

1 ‘‘(B) Plans to outline the tasks, timelines, 

2 and costs required to complete the development 

3 process for promising drug and biological can4 didates. 

5 ‘‘(C) Implementation of the recommended 

6 development steps for key therapeutics. 

7 ‘‘(D) Project management to implement 

8 the recommended development steps. 

9 ‘‘(E) Regulatory consultants to interface 

10 with the Food and Drug Administration and 

11 the entity to devise a plan that rapidly brings 

12 new biodefense candidates to approval and 

13 stockpiling. 

14 ‘‘(q) RULE OF CONSTRUCTION.—Nothing in this sec15 tion shall be construed to limit the authority of the Sec16 retary or the Secretary of Homeland Security to distribute 

17 countermeasures from the Strategic National Stockpile to 

18 foreign countries or foreign entities if it is determined by 

19 such Secretaries that such a deployment would protect the 

20 interests and safety of citizens of the United States, living 

21 in the United States or abroad, from the event of a bioter22 rorist attack or other public health emergency.’’. 
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1 TITLE V—BIOSHIELD ANTITRUST 

2 EXEMPTION 

3 SEC. 501. LIMITED ANTITRUST EXEMPTION. 

4 Section 2 of the Clayton Act (15 U.S.C. 13) is 

5 amended by adding at the end the following: 

6 ‘‘(g) LIMITED ANTITRUST EXEMPTION.— 

7 ‘‘(1) COUNTERMEASURES DEVELOPMENT MEET8 INGS.— 

9 ‘‘(A) COUNTERMEASURES DEVELOPMENT

10 MEETINGS AND CONSULTATIONS.—The Sec11 retary may conduct meetings and consultations 

12 with parties involved in the development of 

13 countermeasures for the purpose of the develop14 ment, manufacture, distribution, purchase, or 

15 sale of countermeasures consistent with the 

16 purposes of this title. The Secretary shall give 

17 notice of such meetings and consultations to the 

18 Attorney General and the Chairperson of the 

19 Federal Trade Commission (referred to in this 

20 subsection as the ‘Chairperson’). 

21 ‘‘(B) MEETING AND CONSULTATION CON22 DITIONS.—A meeting or consultation conducted 

23 under subparagraph (A) shall— 

24 ‘‘(i) be chaired or, in the case of a 

25 consultation, facilitated by the Secretary; 
141 

S 975 IS 

1 ‘‘(ii) be open to parties involved in the 

2 development, manufacture, distribution, 

3 purchase, or sale of countermeasures, as 

4 determined by the Secretary; 

5 ‘‘(iii) be open to the Attorney General 

6 and the Chairperson; 

7 ‘‘(iv) be limited to discussions involv8 ing the development, manufacture, dis9 tribution, or sale of countermeasures, con10 sistent with the purposes of this title; and 

11 ‘‘(v) be conducted in such manner as 

12 to ensure that national security, confiden13 tial, and proprietary information is not dis14 closed outside the meeting or consultation. 

15 ‘‘(C) MINUTES.—The Secretary shall 

16 maintain minutes of meetings and consultations 

17 under this subsection, which shall not be dis18 closed under section 552 of title 5, United 

19 States Code. 

20 ‘‘(D) EXEMPTION.—The antitrust laws 

21 shall not apply to meetings and consultations 

22 under this paragraph, except that any agree23 ment or conduct that results from a meeting or 

24 consultation and that does not receive an ex-
142 

S 975 IS 

1 emption pursuant to this subsection shall be 

2 subject to the antitrust laws. 

3 ‘‘(2) WRITTEN AGREEMENTS.—The Secretary 

4 shall file a written agreement regarding covered ac5 tivities, made pursuant to meetings or consultations 

6 conducted under paragraph (1) and that is con7 sistent with this paragraph, with the Attorney Gen8 eral and the Chairperson for a determination of the 

9 compliance of such agreement with antitrust laws. 

10 In addition to the proposed agreement itself, any 

11 such filing shall include— 

12 ‘‘(A) an explanation of the intended pur13 pose of the agreement; 

14 ‘‘(B) a specific statement of the substance 

15 of the agreement; 

16 ‘‘(C) a description of the methods that will 

17 be utilized to achieve the objectives of the 

18 agreement; 

19 ‘‘(D) an explanation of the necessity of a 

20 cooperative effort among the particular partici21 pating parties to achieve the objectives of the 

22 agreement; and 

23 ‘‘(E) any other relevant information deter24 mined necessary by the Secretary in consulta-
143 

S 975 IS 

1 tion with the Attorney General and the Chair2 person. 

3 ‘‘(3) DETERMINATION.—The Attorney General, 

4 in consultation with the Chairperson, shall determine 

5 whether an agreement regarding covered activities 

6 referred to in paragraph (2) would likely— 

7 ‘‘(A) be in compliance with the antitrust 

8 laws, and so inform the Secretary and the par9 ticipating parties; or 

10 ‘‘(B) violate the antitrust laws, in which 

11 case, the filing shall be deemed to be a request 

12 for an exemption from the antitrust laws, lim13 ited to the performance of the agreement con14 sistent with the purposes of this title. 

15 ‘‘(4) ACTION ON REQUEST FOR EXEMPTION.— 

16 ‘‘(A) IN GENERAL.—The Attorney General, 

17 in consultation with the Chairperson, shall 

18 grant, deny, grant in part and deny in part, or 

19 propose modifications to a request for exemp20 tion from the antitrust laws under paragraph 

21 (3) within 15 days of the receipt of such re22 quest. 

23 ‘‘(B) EXTENSION.—The Attorney General 

24 may extend the 15-day period referred to in 

25 subparagraph (A) for an additional period of 
144 

S 975 IS 

1 not to exceed 10 days. Such additional period 

2 may be further extended only by the United 

3 States district court, upon an application by the 

4 Attorney General after notice to the Secretary 

5 and the parties involved. 

6 ‘‘(C) DETERMINATION.—In granting an 

7 exemption under this paragraph, the Attorney 

8 General, in consultation with the Chairperson 

9 and the Secretary— 

10 ‘‘(i) must find— 

11 ‘‘(I) that the agreement involved 

12 is necessary to ensure the availability 

13 of countermeasures; 

14 ‘‘(II) that the exemption from 

15 the antitrust laws would promote the 

16 public interest; and 

17 ‘‘(III) that there is no substantial 

18 competitive impact to areas not di19 rectly related to the purposes of the 

20 agreement; and 

21 ‘‘(ii) may consider any other factors 

22 determined relevant by the Attorney Gen23 eral and the Chairperson. 

24 ‘‘(5) LIMITATION ON AND RENEWAL OF EXEMP25 TIONS.—An exemption granted under paragraph (4) 
145 

S 975 IS 

1 shall be limited to covered activities, and shall expire 

2 on the date that is 3 years after the date on which 

3 the exemption becomes effective (and at 3-year in4 tervals thereafter, if renewed) unless the Attorney 

5 General in consultation with the Chairperson deter6 mines that the exemption should be renewed (with 

7 modifications, as appropriate) considering the fac8 tors described in paragraph (4). 

9 ‘‘(6) LIMITATION ON PARTIES.—The use of any 

10 information acquired under an exempted agreement 

11 by the parties to such an agreement for any pur12 poses other than those specified in the antitrust ex13 emption granted by the Attorney General shall be 

14 subject to the antitrust laws and any other applica15 ble laws. 

16 ‘‘(7) GUIDELINES.—The Attorney General and 

17 the Chairperson may develop and issue guidelines to 

18 implement this subsection. 

19 ‘‘(8) REPORT.—Not later than 1 year after the 

20 date of enactment of the Project BioShield II Act of 

21 2005, and annually thereafter, the Attorney General 

22 and the Chairperson shall report to Congress on the 

23 use and continuing need for the exemption from the 

24 antitrust laws provided by this subsection. 
146 

S 975 IS 

1 ‘‘(9) SUNSET.—The authority of the Attorney 

2 General to grant or renew a limited antitrust exemp3 tion under this subsection shall expire at the end of 

4 the 10-year period that begins on the date of enact5 ment of the Project BioShield II Act of 2005. 

6 ‘‘(h) DEFINITIONS.—In this section: 

7 ‘‘(1) ANTITRUST LAWS.—The term ‘antitrust 

8 laws’— 

9 ‘‘(A) has the meaning given such term in 

10 subsection (a) of the first section of the Clayton 

11 Act (15 U.S.C. 12(a)), except that such term 

12 includes the Act of June 19, 1936 (15 U.S.C. 

13 13 et seq.) commonly known as the Robinson14 Patman Act), and section 5 of the Federal 

15 Trade Commission Act (15 U.S.C. 45) to the 

16 extent such section 5 applies to unfair methods 

17 of competition; and 

18 ‘‘(B) includes any State law similar to the 

19 laws referred to in subparagraph (A). 

20 ‘‘(2) COUNTERMEASURE.—The term ‘counter21 measure’ has the meaning given that term in section 

22 319F–3 of the Public Health Service Act. 

23 ‘‘(3) COVERED ACTIVITIES.— 

24 ‘‘(A) IN GENERAL.—Except as provided in 

25 subparagraph (B), the term ‘covered activities’ 
147 

S 975 IS 

1 means any group of activities or conduct, in2 cluding attempting to make, making, or per3 forming a contract or agreement or engaging in 

4 other conduct, for the purpose of— 

5 ‘‘(i) theoretical analysis, experimen6 tation, or the systematic study of phe7 nomena or observable facts necessary to 

8 the development of countermeasures; 

9 ‘‘(ii) the development or testing of 

10 basic engineering techniques necessary to 

11 the development of countermeasures; 

12 ‘‘(iii) the extension of investigative 

13 findings or theory of a scientific or tech14 nical nature into practical application for 

15 experimental and demonstration purposes, 

16 including the experimental production and 

17 testing of models, prototypes, equipment, 

18 materials, and processes necessary to the 

19 development of countermeasures; 

20 ‘‘(iv) the production, distribution, or 

21 marketing of a product, process, or service 

22 that is a countermeasures; 

23 ‘‘(v) the testing in connection with the 

24 production of a product, process, or serv-
148 

S 975 IS 

1 ices necessary to the development of coun2 termeasures; 

3 ‘‘(vi) the collection, exchange, and 

4 analysis of research or production informa5 tion necessary to the development of coun6 termeasures; or 

7 ‘‘(vii) any combination of the purposes 

8 described in clauses (i) through (vi); 

9 and such term may include the establishment 

10 and operation of facilities for the conduct of 

11 covered activities described in clauses (i) 

12 through (vi), the conduct of such covered activi13 ties on a protracted and proprietary basis, and 

14 the processing of applications for patents and 

15 the granting of licenses for the results of such 

16 covered activities. 

17 ‘‘(B) EXCEPTION.—The term ‘covered ac18 tivities’ shall not include the following activities 

19 involving 2 or more persons: 

20 ‘‘(i) Exchanging information among 

21 competitors relating to costs, sales, profit22 ability, prices, marketing, or distribution of 

23 any product, process, or service if such in24 formation is not reasonably necessary to 
149 

S 975 IS 

1 carry out the purposes of covered activi2 ties. 

3 ‘‘(ii) Entering into any agreement or 

4 engaging in any other conduct— 

5 ‘‘(I) to restrict or require the 

6 sale, licensing, or sharing of inven7 tions, developments, products, proc8 esses, or services not developed 

9 through, produced by, or distributed 

10 or sold through such covered activi11 ties; or 

12 ‘‘(II) to restrict or require par13 ticipation by any person who is a 

14 party to such covered activities in 

15 other research and development activi16 ties, that is not reasonably necessary 

17 to prevent the misappropriation of 

18 proprietary information contributed 

19 by any person who is a party to such 

20 covered activities or of the results of 

21 such covered activities. 

22 ‘‘(iii) Entering into any agreement or 

23 engaging in any other conduct allocating a 

24 market with a competitor that is not ex-
150 

S 975 IS 

1 pressly exempted from the antitrust laws 

2 by a determination under subsection (i)(4). 

3 ‘‘(iv) Exchanging information among 

4 competitors relating to production (other 

5 than production by such covered activities) 

6 of a product, process, or service if such in7 formation is not reasonably necessary to 

8 carry out the purpose of such covered ac9 tivities. 

10 ‘‘(v) Entering into any agreement or 

11 engaging in any other conduct restricting, 

12 requiring, or otherwise involving the pro13 duction of a product, process, or service 

14 that is not so expressly exempted from the 

15 antitrust laws by a determination under 

16 subsection (i)(4). 

17 ‘‘(vi) Except as otherwise provided in 

18 this subsection, entering into any agree19 ment or engaging in any other conduct to 

20 restrict or require participation by any per21 son who is a party to such activities, in 

22 any unilateral or joint activity that is not 

23 reasonably necessary to carry out the pur24 pose of such covered activities. 
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1 ‘‘(4) DEVELOPMENT.—The term ‘development’ 

2 includes the identification of suitable compounds or 

3 biological materials, the conduct of preclinical and 

4 clinical studies, the preparation of an application for 

5 marketing approval, and any other actions related to 

6 preparation of a countermeasure. 

7 ‘‘(5) PERSON.—The term ‘person’ has the 

8 meaning given such term in subsection (a) of the 

9 first section of this Act. 

10 ‘‘(6) SECRETARY.—The term ‘Secretary’ means 

11 the Secretary of Health and Human Services.’’. 

12 TITLE VI—BIOSHIELD 

13 IMMIGRATION PRIORITY 

14 SEC. 601. H1B VISA EXEMPTION. 

15 Section 214(g) of the Immigration and Nationality 

16 Act (8 U.S.C. 1184(g)) is amended by adding at the end 

17 the following new paragraph: 

18 ‘‘(9)(A) The numerical limitations contained in para19 graph (1)(A) shall not apply to any nonimmigrant alien 

20 issued a visa or otherwise provided status under section 

21 101(a)(15)(H)(i)(b) who— 

22 ‘‘(i) is employed by a person that has entered 

23 into a contract for procurement with the Secretary 

24 of Health and Human Services under the authority 

25 provided in section 319F–1 or 319F–2 of the Public 
152 

S 975 IS 

1 Health Service Act (42 U.S.C. 247d–6a and 247d– 

2 6b) or with the Secretary of Homeland Security 

3 under section 512 of the Homeland Security Act of 

4 2002; and 

5 ‘‘(ii) provides services related to the research, 

6 development, or production of a qualified counter7 measure or a security countermeasure under such 

8 contract. 

9 ‘‘(B) In this paragraph: 

10 ‘‘(i) The term ‘qualified countermeasure’ has 

11 the meaning given that term in section 319F–1 of 

12 the Public Health Service Act. 

13 ‘‘(ii) The term ‘security countermeasure’ has 

14 the meaning given that term in section 319F–2 of 

15 the Public Health Service Act.’’. 

16 SEC. 602. VISA PROCESSING. 

17 (a) REQUIREMENT TO EXPEDITE.—The Secretary of 

18 Homeland Security and the Secretary of State shall expe19 dite the processing of an application of an alien seeking 

20 a visa under section 101(a)(15)(H)(i)(b) of the Immigra21 tion and Nationality Act (8 U.S.C. 1101(a)(15)(H)(i)(b)) 

22 if such alien— 

23 (1) is employed by a person that has entered 

24 into a contract for procurement with the Secretary 

25 of Health and Human Services under the authority 
153 

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1 provided in section 319F–1 or 319F–2 of the Public 

2 Health Service Act (42 U.S.C. 247d–6a and 247d– 

3 6b) or with the Secretary of Homeland Security 

4 under section 512 of the Homeland Security Act of 

5 2002; and 

6 (2) provides services related to the research, de7 velopment, or production of a qualified counter8 measure or a security countermeasure under such 

9 contract. 

10 (b) DEFINITIONS.—In this section: 

11 (1) QUALIFIED COUNTERMEASURE.—The term 

12 ‘‘qualified countermeasure’’ has the meaning given 

13 that term in section 319F–1 of the Public Health 

14 Service Act. 

15 (2) SECURITY COUNTERMEASURE.—The term 

16 ‘‘security countermeasure’’ has the meaning given 

17 that term in section 319F–2 of the Public Health 

18 Service Act. 

19 TITLE VII—BIOSHIELD EXPORT 

20 PRIORITY 

21 SEC. 701. SHORT TITLE. 

22 This title may be cited as the ‘‘Bioshield Export Pri23 ority Act’’. 
154 

S 975 IS 

1 SEC. 702. REQUIREMENT TO EXPEDITE EXPORT APPLICA2 TIONS. 

3 (a) IN GENERAL.—The Secretary of Commerce or 

4 the Secretary of Health and Human Services, whichever 

5 is applicable, shall expedite the processing of a request to 

6 export a drug, medical device, diagnostic test, etiological 

7 agent, biological product, or any item the export of which 

8 is restricted pursuant to section 5 or 6 of the Export Ad9 ministration Act of 1979 (as in effect pursuant to the 

10 International Emergency Economic Powers Act; 50 U.S.C. 

11 1701 et seq.), if the export of that drug, medical device, 

12 diagnostic test, etiological agent, biological product, or 

13 other item is necessary to carry out a procurement con14 tract entered into by the Secretary of Health and Human 

15 Services under the authority provided in section 319F– 

16 1 or section 319F–2 of the Public Health Service Act (42 

17 U.S.C. 247d–6a and 247d–6b), or by the Secretary of 

18 Homeland Security under section 512 of the Homeland 

19 Security Act of 2002, with respect to a qualified counter20 measure or security countermeasure under such contract. 

21 (b) QUALIFIED AND SECURITY COUNTERMEASURES

22 DEFINED.—In this section: 

23 (1) the term ‘‘qualified countermeasure’’ has 

24 the meaning given that term in section 319F–1 of 

25 the Public Health Service Act (42 U.S.C. 247d–6a); 

26 and 
155 

S 975 IS 

1 (2) the term ‘‘security countermeasure’’ has the 

2 meaning given that term in section 319F–2 of the 

3 Public Health Service Act (42 U.S.C. 247d–6b). 

4 SEC. 703. PRESERVATION OF FOREIGN SALES MARKETS 

5 FOR QUALIFIED AND SECURITY COUNTER6 MEASURES. 

7 Notwithstanding any other provision of law, no Fed8 eral agency shall sell, barter, trade, or transfer a qualified 

9 countermeasure or a security countermeasure to a foreign 

10 government, or to any other foreign entity or purchaser 

11 outside the United States where an entity that has suc12 cessfully developed a countermeasure under this Act or the 

13 Project BioShield Act of 2004 (Public Law 108–276) (and 

14 the amendments made by such Acts) is able to sell, barter, 

15 trade, or transfer such countermeasure to such foreign 

16 government or entity, unless the President makes a deter17 mination that such sale, barter, trade, or transfer is nec18 essary for protecting the national security or national de19 fense of the United States. 
156 

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1 TITLE VIII—OFFICE OF PUBLIC 

2 HEALTH COUNTERMEASURE 

3 DEVELOPMENT 

4 SEC. 801. OFFICE OF PUBLIC HEALTH COUNTERMEASURE 

5 DEVELOPMENT. 

6 Section 2811(a) of the Public Health Service Act (42 

7 U.S.C. 300hh–11(a)) is amended to read as follows: 

8 ‘‘(a) ASSISTANT SECRETARY FOR PUBLIC HEALTH

9 COUNTERMEASURE DEVELOPMENT.— 

10 ‘‘(1) IN GENERAL.—There is established within 

11 the Department of Health and Human Services the 

12 Office of Public Health Countermeasure Develop13 ment (referred to in this subsection as the ‘Office’). 

14 Such Office shall be headed by an Assistant Sec15 retary for Public Health Countermeasure Develop16 ment, who shall be appointed by the President and 

17 shall report to the Secretary. 

18 ‘‘(2) DEPUTY DIRECTOR.—There is established 

19 within the Department of Health and Human Serv20 ices the position of Deputy Director for Medical 

21 Countermeasure Development. 

22 ‘‘(3) DUTIES.—The Assistant Secretary for 

23 Public Health Countermeasure Development shall 

24 ensure that research supported by the Department 

25 of Health and Human Services— 
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1 ‘‘(A) is consistent with the national pre2 paredness plan developed under section 2812 

3 with respect to— 

4 ‘‘(i) identifying priorities, goals, objec5 tives, and policies for identifying, devel6 oping, delivering, and evaluating medical 

7 and other countermeasures to biological, 

8 chemical, radiological, nuclear, and other 

9 emerging natural and terrorists threats 

10 and infectious diseases and research tools 

11 and countermeasures should include con12 tainment and decontamination strategies 

13 for human and animal remains; and 

14 ‘‘(ii) coordinating the civilian efforts 

15 of the Federal Government to identify and 

16 rapidly develop such countermeasures; and 

17 ‘‘(B) is conducted pursuant to a com18 prehensive, research-based strategy for— 

19 ‘‘(i) the conduct of basic and applied 

20 research; 

21 ‘‘(ii) the development of the counter22 measures described under subparagraph 

23 (A)(i); and 
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1 ‘‘(iii) the development of standards by 

2 which the goals of such strategy may be 

3 accomplished and evaluated.’’. 

4 SEC. 802. BIOTERROR, CHEMICAL, NUCLEAR, RADIO5 LOGICAL, AND INFECTIOUS DISEASE COUN6 TERMEASURE DEVELOPMENT STRATEGY. 

7 Subtitle B of title XXVIII of the Public Health Serv8 ice Act (42 U.S.C. 300hh–11 et seq.) is amended by add9 ing at the end the following: 

10 ‘‘SEC. 2812. BIOTERROR, CHEMICAL, NUCLEAR, RADIO11 LOGICAL, AND INFECTIOUS DISEASE COUN12 TERMEASURE DEVELOPMENT STRATEGY. 

13 ‘‘(a) PLAN FOR COUNTERMEASURE RESEARCH.— 

14 ‘‘(1) IN GENERAL.—The Secretary, in consulta15 tion with the Secretary of Defense and the Secretary 

16 of Homeland Security, shall develop a comprehen17 sive, long-term plan for engaging State and local 

18 public health officials, medical examiners, and other 

19 non-Federal entities, including private for-profit en20 tities, in the research, development, production, de21 livery, and evaluation of countermeasures for biologi22 cal, chemical, radiological, and nuclear weapons and 

23 infectious diseases. 

24 ‘‘(2) CONTENTS.—The plan described under 

25 paragraph (1) shall include a plan for the develop-
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1 ment of countermeasures for exotic pathogens (in2 cluding vaccine resistant bacterial or viral strains, 

3 antibiotic resistant organisms, genetically modified 

4 organisms, hybrid organisms, synthetic organisms, 

5 autoimmune peptides, antibiotic-induced toxins, eth6 nic and racial specific pathogens, and bioregulators 

7 and biomodulators) and measures for containment 

8 and safe handling of contaminated human and ani9 mal remains. 

10 ‘‘(3) OTHER DUTIES.—The Secretary, in con11 sultation with the Secretary of Defense and the Sec12 retary of Homeland Security, shall— 

13 ‘‘(A) develop a plan and strategy for en14 gaging pharmaceutical and biotechnology com15 panies, universities, small businesses, and non16 profit institutions, including entities that are 

17 under-resourced and not able to advance beyond 

18 preclinical development to clinical trials, in 

19 order to create a multi-dimensional biodefense, 

20 infectious disease, vaccine, and research tool in21 dustry; and 

22 ‘‘(B) provide joint oversight of 

23 translational development for biodefense drug 

24 and vaccine candidates, as provided in section 

25 319F–2(o). 
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1 ‘‘(4) COORDINATION; PURPOSE.—In developing 

2 the plan described under paragraph (1), the Sec3 retary, in consultation with the Secretary of Defense 

4 and the Secretary of Homeland Security, shall— 

5 ‘‘(A) consult with— 

6 ‘‘(i) other Federal agencies with ex7 pertise in research, development, and pro8 duction of the countermeasures described 

9 under paragraph (1); 

10 ‘‘(ii) private, for-profit entities, State 

11 and local public health officials, medical 

12 examiners, and entrepreneurs with exper13 tise and technology with respect to such 

14 countermeasures, research tools, and the 

15 systems for developing such research tools; 

16 ‘‘(iii) investors that fund the entities 

17 described under clause (ii); 

18 ‘‘(iv) nonprofit research universities 

19 and institutions; 

20 ‘‘(v) professional organizations rep21 resenting infectious disease physicians and 

22 scientists; 

23 ‘‘(vi) local public health and hospital 

24 organizations; and 
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1 ‘‘(vii) national and international 

2 healthcare delivery and public health enti3 ties, and other interested private and pub4 lic entities; 

5 ‘‘(B) evaluate proposals to ensure that— 

6 ‘‘(i) Federal efforts assist and 

7 incentivize private sector development of 

8 systems to facilitate and expedite the de9 velopment and diffusion of research tools, 

10 and research tool systems, to aid in the de11 velopment and deployment of counter12 measures; 

13 ‘‘(ii) research and development of 

14 such countermeasures by non-Federal enti15 ties is likely to yield countermeasures that 

16 may be procured and deployed with respect 

17 to the homeland security in the United 

18 States and against an infectious diseases; 

19 ‘‘(iii) ample investor capital is avail20 able to fund such research and develop21 ment, and non-Federal entities are not de22 pendent on grants from the Federal Gov23 ernment; 

24 ‘‘(iv) the terms of procurement of 

25 such countermeasures are defined in ad-
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1 vance so that entities may accurately and 

2 reliably assess— 

3 ‘‘(I) the potential counter4 measures market; 

5 ‘‘(II) the potential rate of return; 

6 and 

7 ‘‘(III) that the terms of the pro8 curement are comparable to the pro9 curement of other medicines and bio10 logical products from other markets; 

11 ‘‘(v) appropriate intellectual property, 

12 risk protection, and Government approval 

13 standards are applicable to such counter14 measures; 

15 ‘‘(vi) federally funded research is con16 ducted and prioritized to address the high17 est priority countermeasure detection tools 

18 and transfer or license those technologies, 

19 as appropriate, to non-Federal entities for 

20 production; and 

21 ‘‘(vii) universities, State and local gov22 ernment laboratories, and research institu23 tions play a vital role as partners in re24 search, development, and technology trans25 fer, with appropriate progress benchmarks 
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1 for such activities, with for-profit entities; 

2 and 

3 ‘‘(C) provide the private sector with suffi4 cient advance notice of the procurement prior5 ities of the Federal Government with respect to 

6 countermeasures. 

7 ‘‘(5) PLAN DETAILS.— 

8 ‘‘(A) IN GENERAL.—The plan described 

9 under paragraph (1) shall, on an annual 

10 basis— 

11 ‘‘(i) designate, in 5 year increments, 

12 specific countermeasures for which con13 tracts under the Project BioShield Act of 

14 2004 and the Project BioShield II Act of 

15 2005 will be awarded; 

16 ‘‘(ii) estimate the date on which re17 quest for proposals will be published; 

18 ‘‘(iii) provide information regarding 

19 the qualifications of the entities with which 

20 it may enter into an agreement; and 

21 ‘‘(iv) list the projected schedule for 

22 the completion of the development of such 

23 countermeasures. 

24 ‘‘(B) DESIGNATION OF COUNTER25 MEASURES.— 
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1 ‘‘(i) IN GENERAL.—The plan de2 scribed in paragraph (1) shall, on an an3 nual basis, designate specific counter4 measures to be developed against terror 

5 weapons or weapons of mass destruction. 

6 ‘‘(ii) INFECTIOUS DISEASE COUNTER7 MEASURES IN THE UNITED STATES.—For 

8 every 5 such countermeasures designated 

9 under clause (i), not less than 2 additional 

10 countermeasures shall be designated for 

11 development against an infectious disease 

12 that— 

13 ‘‘(I) is not a terror weapon or 

14 weapon of mass destruction; and 

15 ‘‘(II) has or may have substantial 

16 incidence in the United States. 

17 ‘‘(iii) GLOBAL INFECTIOUS DISEASE

18 COUNTERMEASURES IN DEVELOPING

19 COUNTRIES.—For every 5 such counter20 measures designated under clause (i), not 

21 less than 2 additional countermeasures 

22 shall be designated for development 

23 against an infectious disease that— 

24 ‘‘(I) is not a terror weapon or 

25 weapon of mass destruction; and 
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1 ‘‘(II) has or may have substantial 

2 incidence largely in developing coun3 tries. 

4 ‘‘(C) DESIGNATION OF RESEARCH TOOLS; 

5 PURCHASE POOLS; ESTIMATION.—The plan de6 scribed in paragraph (1) shall— 

7 ‘‘(i) designate research tools, includ8 ing research tool systems, to be developed; 

9 ‘‘(ii) identify purchase pools with 

10 which the Secretary shall seek to negotiate 

11 for the development of countermeasures; 

12 and 

13 ‘‘(iii) estimate the amount of appro14 priations necessary to procure the develop15 ment of such countermeasures and re16 search tools. 

17 ‘‘(D) PUBLIC AVAILABILITY.—The plan de18 scribed in paragraph (1) shall be published in 

19 the Federal Register. 

20 ‘‘(6) PERFORMANCE MEASURE SYSTEM.— 

21 ‘‘(A) IN GENERAL.—Not later than 180 

22 days after the development of the plan de23 scribed in paragraph (1), the Secretary shall 

24 implement a performance measure system to 

25 evaluate the progress toward the goals of the 
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1 Project BioShield II Act of 2005, which shall 

2 include a list of clear, measurable benchmarks 

3 by which progress may be evaluated, includ4 ing— 

5 ‘‘(i) a list of threats for which coun6 termeasures are necessary; 

7 ‘‘(ii) a list of research and research 

8 tool systems necessary for the development 

9 of countermeasures; 

10 ‘‘(iii) systems to develop and deliver 

11 countermeasures for at-risk populations; 

12 ‘‘(iv) an annual accounting of the 

13 number of outbreaks, including incidence 

14 numbers and case fatality rates, in the 

15 United States of influenza and other such 

16 diseases that such Act addresses; 

17 ‘‘(v) a list of any new threats that ei18 ther emerged from nature, or that were en19 gineered and released during the previous 

20 year; and 

21 ‘‘(vi) an accounting of the time that it 

22 took to detect, analyze, and respond to any 

23 instance of a threat. 

24 ‘‘(B) EVALUATION.—Not later than 1 year 

25 after the publication of the benchmarks de-
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1 scribed in subparagraph (A), and on annual 

2 basis thereafter, the Secretary shall publish and 

3 submit to Congress an evaluation of the 

4 progress made with respect to such benchmarks 

5 during the preceding year. 

6 ‘‘(7) SUBMISSION OF PLAN; REPORTING.— 

7 ‘‘(A) SUBMISSION OF PLAN.—Not later 

8 than 270 days after the date of enactment of 

9 the Project BioShield II Act of 2005, the Sec10 retary shall submit to Congress the plan devel11 oped under paragraph (1) and recommenda12 tions for the enactment of supporting or ena13 bling legislation with respect to such plan. The 

14 Secretary shall submit to Congress an updated 

15 version of such plan and such recommendations 

16 on an annual basis. 

17 ‘‘(B) REPORTING.—The Secretary shall re18 port periodically to Congress on the status of 

19 the countermeasure research, development, and 

20 production of non-Federal entities, and submit 

21 recommendations for legislation as determined 

22 necessary by the Secretary. 

23 ‘‘(b) ADVISORY COMMITTEE.— 

24 ‘‘(1) ESTABLISHMENT OF COMMITTEE.—The 

25 Secretary, in consultation with the Secretary of De-
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1 fense and the Secretary of Homeland Security, shall 

2 establish an advisory committee to be known as the 

3 Public Health Countermeasure Development Advi4 sory Committee (referred to in this section as the 

5 ‘Advisory Committee’). 

6 ‘‘(2) DUTIES.—The Advisory Committee shall 

7 advise the Secretary, the Secretary of Defense, and 

8 the Secretary of Homeland Security with respect to 

9 the establishment of a biodefense, an infectious dis10 ease, vaccine, and a research tool industry to supply 

11 the Federal Government and other public entities 

12 with the medical countermeasures necessary to pro13 tect the public from biological, chemical, radiological, 

14 and nuclear attacks, or infectious diseases. 

15 ‘‘(3) MEMBERSHIP.—The Secretary, Secretary 

16 of Defense, and the Secretary of Homeland Security 

17 shall appoint the members of the Advisory Com18 mittee, which shall be composed of— 

19 ‘‘(A) representatives of the for-profit and 

20 nonprofit research sectors, and State and local 

21 governments, including representatives of the 

22 small business industry and infectious disease 

23 medical, research, biotechnology, and pharma24 ceutical communities; and 
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1 ‘‘(B) experts on the terms and impact of 

2 the incentives provided under the Project Bio3 Shield Act of 2004 or the Project BioShield II 

4 Act of 2005 (and the amendments made by 

5 such Acts). 

6 ‘‘(4) VACANCIES.—Any vacancy in the Advisory 

7 Committee shall not affect its powers, but shall be 

8 filled in the same manner as the original appoint9 ment. 

10 ‘‘(5) MEETINGS.—The Advisory Committee 

11 shall meet at the call of the co-chairpersons. 

12 ‘‘(6) CO-CHAIRPERSONS.—The Secretary, the 

13 Secretary of Defense, and the Secretary of Health 

14 and Human Services shall serve as the co-chair15 persons of the Advisory Committee. 

16 ‘‘(7) POWERS.— 

17 ‘‘(A) HEARINGS.—The Advisory Com18 mittee may hold such hearings, sit and act at 

19 such times and places, take such testimony, and 

20 receive such evidence as the Advisory Com21 mittee considers advisable to carry out this sec22 tion. 

23 ‘‘(B) INFORMATION FROM FEDERAL AGEN24 CIES.— 
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1 ‘‘(i) IN GENERAL.—The Advisory 

2 Committee may secure directly from any 

3 Federal department or agency such infor4 mation as the Advisory Committee con5 siders necessary to carry out the provisions 

6 of this section. Upon request of the Advi7 sory Committee, the head of such depart8 ment or agency shall furnish such informa9 tion to the Advisory Committee. 

10 ‘‘(ii) LIMITATION.—Nothing in this 

11 subsection shall be construed to allow the 

12 Advisory Committee to secure information 

13 that is exempt from disclosure under sec14 tion 552 of title 5, United States Code 

15 (commonly referred to as the Freedom of 

16 Information Act). 

17 ‘‘(C) POSTAL SERVICES.—The Advisory 

18 Committee may use the United States mails in 

19 the same manner and under the same condi20 tions as other departments and agencies of the 

21 Federal Government. 

22 ‘‘(8) PERSONNEL.— 

23 ‘‘(A) TRAVEL EXPENSES.—The members 

24 of the Advisory Committee shall not receive 

25 compensation for the performance of services 
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1 for the Advisory Committee, but shall be al2 lowed travel expenses, including per diem in lieu 

3 of subsistence, at rates authorized for employ4 ees of agencies under subchapter I of chapter 

5 57 of title 5, United States Code, while away 

6 from their homes or regular places of business 

7 in the performance of services for the Advisory 

8 Committee. Notwithstanding section 1342 of 

9 title 31, United States Code, the Secretary may 

10 accept the voluntary and uncompensated serv11 ices of members of the Advisory Committee. 

12 ‘‘(B) DETAIL OF GOVERNMENT EMPLOY13 EES.—Any Federal Government employee may 

14 be detailed to the Advisory Committee without 

15 reimbursement, and such detail shall be without 

16 interruption or loss of civil service status or 

17 privilege.’’. 
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1 TITLE IX—OFFICE OF MEDICAL 

2 READINESS AND RESPONSE 

3 OF THE DEPARTMENT OF 

4 HOMELAND SECURITY 

5 SEC. 901. OFFICE OF MEDICAL READINESS AND RESPONSE 

6 OF THE DEPARTMENT OF HOMELAND SECU7 RITY. 

8 (a) IN GENERAL.—Title VIII of the Homeland Secu9 rity Act of 2002 (6 U.S.C. 361 et seq.) is amended by 

10 inserting after section 879 the following: 

11 ‘‘SEC. 879A. OFFICE OF MEDICAL READINESS AND RE12 SPONSE. 

13 ‘‘(a) ESTABLISHMENT.—There is established within 

14 the Office of the Secretary an Office of Medical Readiness 

15 and Response. 

16 ‘‘(b) ASSISTANT SECRETARY.—The Office estab17 lished under subsection (a) shall be headed by an Assist18 ant Secretary for Medical Readiness and Response, who 

19 shall be appointed by the President by and with the advice 

20 and consent of the Senate. 

21 ‘‘(c) DUTIES OF THE ASSISTANT SECRETARY.—The 

22 Assistant Secretary for Medical Readiness and Response 

23 shall— 
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1 ‘‘(1) serve as the principal advisor to the Sec2 retary on all matters related to emergency medical 

3 preparedness and response; 

4 ‘‘(2) develop Federal strategy, training (includ5 ing exercises), coordination, funding, and implemen6 tation of emergency medical response to mass cas7 ualty events for Federal, State, and local public 

8 health agencies and private sector entities in support 

9 of homeland security; 

10 ‘‘(3) serve as the primary Federal official with 

11 respect to overseeing the identification and develop12 ment, in consultation with nonprofit health and pub13 lic health departments and medical centers, of med14 ical preparedness centers and deployable medical 

15 care units designed to meet the demands of a ter16 rorist event or other incident requiring mass cas17 ualty care and containment of infectious disease; 

18 ‘‘(4) serve as the primary official of the Depart19 ment relating to and overseeing medical emer20 gencies, including emergencies incident to a terrorist 

21 attack or naturally occurring infectious disease out22 break; 

23 ‘‘(5) in coordination with the Secretary of 

24 Health and Human Services, have the authority to 
174 

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1 deploy the Strategic National Stockpile and the 

2 Commissioned Corps of the Public Health Service; 

3 ‘‘(6) report directly to the Secretary; and 

4 ‘‘(7) evaluate and report to Congress on the 

5 preparedness of Federal, State, and local agencies to 

6 respond to major medical disaster. 

7 ‘‘(d) FUNCTIONS.—There shall be transferred to the 

8 Office of Medical Readiness and Response the following 

9 functions, personnel, assets, and liabilities of the following: 

10 ‘‘(1) The National Disaster Medical System 

11 (transferred to the Department pursuant to section 

12 503(5)). 

13 ‘‘(2) The Metropolitan Medical Response Sys14 tem (transferred to the Department pursuant to sec15 tion 503(5)). 

16 ‘‘(3) The emergency medical response functions 

17 of the Office of Emergency Preparedness (trans18 ferred to the Department pursuant to section 

19 503(5)). 

20 ‘‘(4) Other resources and offices of the Depart21 ment as designated by the Secretary.’’. 

22 (b) CONFORMING AMENDMENTS.—Section 502(3) of 

23 the Homeland Security Act of 2002 (6 U.S.C. 312(3)) is 

24 amended— 

25 (1) in subparagraph (B)— 
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1 (A) by striking ‘‘, the National Disaster 

2 Medical System,’’; and 

3 (B) by striking the semicolon and inserting 

4 ‘‘; and’’; 

5 (2) by striking subparagraph (C); and 

6 (3) by redesignating subparagraph (D) as sub7 paragraph (C). 

8 TITLE X—NATIONAL EMER9 GENCY MEDICAL READINESS 

10 AND RESPONSE BOARD 

11 SEC. 1001. NATIONAL EMERGENCY MEDICAL READINESS 

12 AND RESPONSE BOARD. 

13 (a) IN GENERAL.—Title VIII of the Homeland Secu14 rity Act of 2002 (6 U.S.C. 361 et seq.), as amended by 

15 section 901, is further amended by inserting after section 

16 879A (as added by section 901) the following: 

17 ‘‘SEC. 879B. NATIONAL EMERGENCY MEDICAL READINESS 

18 AND RESPONSE BOARD. 

19 ‘‘(a) ESTABLISHMENT OF BOARD.— 

20 ‘‘(1) IN GENERAL.—There is established in the 

21 Department the National Emergency Medical Readi22 ness and Response Board (referred to in this section 

23 as the ‘Board’). 
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1 ‘‘(2) CHAIRPERSON.—The Assistant Secretary 

2 for Medical Readiness and Response shall serve as 

3 the chairperson of the Board. 

4 ‘‘(3) COMPOSITION.—The Board shall be com5 posed of the following members (or their designees): 

6 ‘‘(A) The Assistant Secretary for Medical 

7 Readiness and Response. 

8 ‘‘(B) The United States Surgeon General. 

9 ‘‘(C) The Assistant Secretary for Public 

10 Health Countermeasure Development. 

11 ‘‘(D) The Director of the National Insti12 tutes of Health. 

13 ‘‘(E) The Director of the Centers for Dis14 ease Control and Prevention. 

15 ‘‘(F) The Director of National Bioter16 rorism and Hospital Readiness of the Health 

17 Resources and Services Administration. 

18 ‘‘(G) The Deputy Assistant to the Sec19 retary of Defense for Chemical and Biological 

20 Defense. 

21 ‘‘(H) The Commanding General, Army 

22 Medical Research and Materiel Command. 

23 ‘‘(I) The Assistant Secretary for Health of 

24 the Department of Veterans Affairs. 
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1 ‘‘(J) The Deputy Commander, United 

2 States Northern Command. 

3 ‘‘(K) The Commissioner of Food and 

4 Drugs. 

5 ‘‘(L) The Secretary of Agriculture. 

6 ‘‘(M) The Postmaster General. 

7 ‘‘(N) Any other individual appointed by the 

8 President to the Board. 

9 ‘‘(4) MEETINGS.—The Board shall meet at the 

10 call of the chairperson. 

11 ‘‘(b) DUTIES AND POWERS.— 

12 ‘‘(1) DUTIES.—The Board shall oversee the fol13 lowing activities: 

14 ‘‘(A) The development, assessment, and 

15 validation of national, interagency, emergency 

16 medical response plans, in coordination with 

17 State and local public health officials, for bio18 terrorism (including agroterrorism), chemical 

19 attack, radiological attack, nuclear attack, in20 fectious disease, and high explosives attack. 

21 ‘‘(B) In cooperation with State and local 

22 public health agencies, the development, testing, 

23 and implementation of a plan for the necessary 

24 training related to, and the assessment and 
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1 evaluation of, the Federal emergency medical 

2 response plans described in subparagraph (A). 

3 ‘‘(C) The coordination of the Federal 

4 emergency medical response plans described in 

5 subparagraph (A) among all the Federal de6 partments and agencies represented on the 

7 Board through joint exercises that shall be ob8 served and evaluated by the members of the 

9 Board (or their designees). 

10 ‘‘(D) Defining, and determining when and 

11 how to implement, national level emergency 

12 medical response plans to medical disasters. 

13 ‘‘(2) POWERS.—The Board may secure directly 

14 from any Federal department or agency such infor15 mation as the Board considers necessary to carry 

16 out this subsection. Upon request of the chairperson 

17 of the Board, the head of such department or agency 

18 shall furnish such information to the Board. 

19 ‘‘(c) BOARD PERSONNEL MATTERS.— 

20 ‘‘(1) DETAIL OF GOVERNMENT EMPLOYEES.— 

21 Any Federal Government employee may be detailed 

22 to the Board without reimbursement, and such de23 tail shall be without interruption or loss of civil serv24 ice status or privilege. 
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1 ‘‘(2) PROCUREMENT OF TEMPORARY AND

2 INTERMITTENT SERVICES.—The chairperson of the 

3 Board may procure temporary and intermittent serv4 ices under section 3109(b) of title 5, United States 

5 Code, at rates for individuals which do not exceed 

6 the daily equivalent of the annual rate of basic pay 

7 prescribed for level V of the Executive Schedule 

8 under section 5316 of such title. 

9 ‘‘(d) ADVISORY COMMITTEE.— 

10 ‘‘(1) ESTABLISHMENT.—Not later than 180 

11 days after the date of enactment of the Project Bio12 Shield II Act of 2005, the Assistant Secretary for 

13 Medical Readiness and Response shall establish an 

14 advisory committee that shall provide assistance and 

15 oversight to the Board and to the Assistant Sec16 retary for Medical Readiness and Response. 

17 ‘‘(2) COMPOSITION.—The advisory committee 

18 established pursuant to paragraph (1) shall consist 

19 of representatives, appointed by the Assistant Sec20 retary for Medical Readiness and Response, of— 

21 ‘‘(A) designees of State and local public 

22 health and emergency management agencies; 

23 ‘‘(B) State and local emergency managers 

24 or adjutant generals and State emergency med25 ical services directors; 
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1 ‘‘(C) physicians and first responders (in2 cluding nurses, police, and paramedics); 

3 ‘‘(D) academic medical research institu4 tions; 

5 ‘‘(E) the World Health Organization; 

6 ‘‘(F) the International Committee of the 

7 Red Cross; 

8 ‘‘(G) the International Federation of Red 

9 Cross and Red Crescent Societies; 

10 ‘‘(H) the American Red Cross; 

11 ‘‘(I) the Infectious Disease Society of 

12 America; 

13 ‘‘(J) professional medical and clinical soci14 eties, as appropriate; 

15 ‘‘(K) local hospitals and hospital districts; 

16 ‘‘(L) medical care delivery facilities (hos17 pital outpatient centers); 

18 ‘‘(M) pharmacies; 

19 ‘‘(N) accredited schools of public health; 

20 ‘‘(O) pathologists, coroners, and chief med21 ical examiners; and 

22 ‘‘(P) other individuals and representatives 

23 of entities appointed by the Assistant Secretary 

24 for Medical Readiness and Response to the ad25 visory committee.’’. 
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1 (b) CONFORMING AMENDMENTS.—The table of con2 tents in section 1(b) of the Homeland Security Act of 

3 2002 (6 U.S.C. 101 note) is amended by— 

4 (1) inserting after the item relating to section 

5 511 the following: 

‘‘Sec. 510. Countermeasure Purchase Fund at the Department of Homeland 

Security.’’; 

6 and 

7 (2) inserting after the item relating to section 

8 879 the following: 

‘‘Sec. 879A. Office of Medical Readiness and Response. 

‘‘Sec. 879B. National Emergency Medical Readiness and Response Board.’’. 

9 TITLE XI—ENCOURAGING 

10 GREATER COORDINATION 

11 WITH FORMER SOVIET SCI12 ENTISTS AND TRANSFER OF 

13 COUNTERMEASURES 

14 SEC. 1101. PURPOSE; REPORT TO CONGRESS. 

15 (a) PURPOSE.—The purpose of this section is to di16 rect the Department of State and the Department of Com17 merce to develop and implement a program to secure the 

18 access to, and transfer of, compounds, culture collections, 

19 devices, scientific methods, and research tools to the 

20 United States to further the protection of the United 

21 States and its allies against biological, chemical, nuclear, 

22 and radiological agents or infectious diseases. Such an ef-
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1 fort must address the state of intellectual property of such 

2 items and ensure the security of such intellectual property 

3 to allow for and encourage commercialization. 

4 (b) REPORT.— 

5 (1) IN GENERAL.—Not later than 180 days 

6 after the date of enactment of the Project BioShield 

7 II Act of 2005, the Secretary of State, in coopera8 tion with the Secretary of Homeland Security and 

9 Secretary of Commerce, shall report to the Com10 mittee on Foreign Relations of the Senate and the 

11 Committee on International Relations of the House 

12 of Representatives on the existence and adequacy of 

13 all United States Government-sponsored programs 

14 or organizations responsible for encouraging com15 mercialization of countermeasures developed by 

16 former-Soviet scientists and current scientists work17 ing within the Commonwealth of Independent States 

18 (referred to in this section as ‘‘CIS’’). 

19 (2) CONTENT OF REPORT.—The report de20 scribed under paragraph (1) shall identify any 

21 known legal prohibitions and practical challenges in 

22 the United States or CIS to the purposes of this sec23 tion, including laws governing intellectual property, 

24 export controls, and classification of information re25 stricting or inhibiting private-sector exchange and 
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1 development of such countermeasures. The Secretary 

2 of State shall provide such information as the Sec3 retary determines to be necessary to enable such po4 tential commercialization and cooperation. 

5 TITLE XII—EMERGENCY CON6 TINUITY OF NATIONAL 

7 HEALTHCARE; REIMBURSE8 MENT OF INFECTIOUS DIS9 EASE PHYSICIANS FOR COM10 MUNITY EMERGENCY PRE11 PAREDNESS ACTIVITIES; 

12 MEDICAL LICENSE RECI13 PROCITY 

14 SEC. 1201. CONTINUITY OF NATIONAL HEALTHCARE SYS15 TEM IN AN EMERGENCY. 

16 Section 319 of the Public Health Service Act (42 

17 U.S.C. 247d) is amended by adding at the end the fol18 lowing: 

19 ‘‘(e) CONTINUITY OF NATIONAL HEALTHCARE SYS20 TEM IN AN EMERGENCY.— 

21 ‘‘(1) EMERGENCY HEALTH INSURANCE REIM22 BURSEMENT.—In the event of a public health emer23 gency determined pursuant to subsection (a), the 

24 Secretary may guarantee reimbursement to public 

25 and private healthcare providers (which shall include 
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1 nurses and non-clinical staff) for care related to the 

2 public health emergency provided to individuals by 

3 such providers to the extent that the public or pri4 vate health insurance reimbursement (as the case 

5 may be) to such providers is not applicable because 

6 of war or terrorism coverage exclusions at one of the 

7 following rates: 

8 ‘‘(A) The applicable rates under the Medi9 care and Medicaid programs. 

10 ‘‘(B) A per diem rate determined by the 

11 Secretary. 

12 ‘‘(2) GUARANTEE OF PAYMENTS.—During a 

13 closure of the United States mails due to a public 

14 health emergency determined pursuant to subsection 

15 (a), the Secretary may provide a guarantee of pay16 ment to private healthcare providers to enable such 

17 providers to maintain services and continuity in re18 sponse to such emergency.’’. 

19 SEC. 1202. REIMBURSEMENT OF INFECTIOUS DISEASE PHY20 SICIANS FOR COMMUNITY EMERGENCY PRE21 PAREDNESS ACTIVITIES. 

22 Section 319 of the Public Health Service Act (as 

23 amended by section 1201) is further amended by adding 

24 at the end the following: 
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1 ‘‘(f) REIMBURSEMENT OF INFECTIOUS DISEASE

2 PHYSICIANS FOR COMMUNITY EMERGENCY PREPARED3 NESS ACTIVITIES.—The Secretary shall reimburse board4 certified infectious disease and public health specialists for 

5 services provided during a public health emergency under 

6 subsection (a) at applicable rates under the Medicare pro7 gram, to the extent that such services are not otherwise 

8 wholly reimbursed by other public or private insurance.’’. 

9 SEC. 1203. MEDICAL LICENSE RECIPROCITY. 

10 Section 319 of the Public Health Service Act (42 

11 U.S.C. 247d) (as amended by section 1202) is further 

12 amended by adding at the end the following: 

13 ‘‘(g) MEDICAL LICENSE RECIPROCITY.—The Sec14 retary may issue regulations requiring the establishment 

15 of reciprocity of medical licensing and certification be16 tween or among States during a national or local public 

17 health emergency determined pursuant to subsection (a). 

18 ‘‘(h) MINIMUM STANDARDS.—Medical licensing for 

19 the purposes of subsection (g) shall include the licensing 

20 of allopathic and osteopathic physicians, registered nurses, 

21 nurse practitioners, physician assistants, pharmacists, 

22 paramedics, respiratory therapists, and other first re23 sponders or allied health professionals. 

24 ‘‘(i) PSA.—The Secretary may issue regulations re25 quiring or providing appropriate liability and workman’s 
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1 compensation coverage for healthcare professionals and 

2 others responding to a public health emergency, as deter3 mined under subsection (a).’’. 

4 SEC. 1204. LIABILITY PROTECTION FOR HEALTHCARE VOL5 UNTEERS AND HOSPITALS. 

6 Part B of title III of the Public Health Service Act 

7 (42 U.S.C. 243 et seq.) (as amended by sections 202, 

8 1402, 1631, 1901, 2101, 2102, and 1631) is amended by 

9 inserting after section 319F–9 (as added by section 203) 

10 the following: 

11 ‘‘SEC. 319F–10. LIABILITY PROTECTION FOR HEALTHCARE 

12 VOLUNTEERS AND HOSPITALS LITIGATION 

13 MANAGEMENT. 

14 ‘‘(a) FEDERAL CAUSE OF ACTION.— 

15 ‘‘(1) IN GENERAL.—There shall exist an exclu16 sive Federal cause of action for claims arising out 

17 of, related to, or resulting from care delivered by any 

18 person or entity at any location in the United States 

19 if the governor of that State has declared a state of 

20 emergency, or the Secretary of Health and Human 

21 Services declares that a public health emergency is 

22 in effect in that State, or the President signs a dis23 aster declaration for that State. Such Federal cause 

24 of action shall be brought in the United States dis25 trict court for the District of Columbia and shall be 
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1 only for injuries that are caused by willful or wanton 

2 misconduct. 

3 ‘‘(2) LIMITATIONS.—Healthcare personnel, vol4 unteers, and other workers providing emergency 

5 medical or triage care in field settings, alternative 

6 treatment facilities, and in vaccination or medication 

7 distribution settings shall be immune from claim for 

8 loss of property (including business interruption or 

9 other types of indirect losses), personal injury, or 

10 death. 

11 ‘‘(b) SPECIAL RULES.— 

12 ‘‘(1) IN GENERAL.—When a hospital is pro13 viding care under emergency conditions as described 

14 in this section and such care is not administered for 

15 or in expectation of compensation, then the max16 imum liability to the Federal Government on behalf 

17 of the hospital (or its employees, volunteers, officers, 

18 and directors) is $250,000 for each claimant. 

19 ‘‘(2) PUNITIVE DAMAGES.—No punitive dam20 ages intended to punish or deter, exemplary dam21 ages, or other damages not intended to compensate 

22 a plaintiff for actual medical expenses or lost wages 

23 may be awarded in an action under this section, nor 

24 shall any party in such action be liable for interest 

25 prior to the judgment. 
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1 ‘‘(3) NONECONOMIC DAMAGES.—No non2 economic damages may be awarded for claims under 

3 this section. 

4 ‘‘(4) LIMITATIONS.—Hospitals and other health 

5 care organizations shall be immune from vicarious li6 ability for the actions of volunteers providing care 

7 under emergency conditions described in this section, 

8 even if the hospital or health care organization is 

9 considered the employer for worker’ compensation 

10 purposes. 

11 ‘‘(5) ATTORNEY FEES.—Attorney fees in an ac12 tion under this section shall be calculated on a rea13 sonable amount of work performed on behalf of the 

14 plaintiff.’’. 

15 TITLE XIII—ADEQUACY OF 

16 EMERGENCY MEDICAL RE17 SPONSE ASSETS FOR HOME18 LAND SECURITY MISSIONS 

19 SEC. 1301. ADEQUACY OF EMERGENCY MEDICAL RESPONSE 

20 ASSETS FOR HOMELAND SECURITY MIS21 SIONS. 

22 (a) STUDY.—The Assistant Secretary for Medical 

23 Readiness and Response of the Department of Homeland 

24 Security shall perform a study and prepare a report as25 sessing the state of medical and health readiness and re-
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1 sponse capability to respond to large-scale medical emer2 gencies, such as terrorist actions. The study will evaluate 

3 the following aspects of medical and health readiness and 

4 response: 

5 (1) The nature and extent of emergency med6 ical and health resources needed to respond to and 

7 mitigate a biological, chemical, radiological, or nu8 clear attack or an infectious disease outbreak. 

9 (2) The assets and resources currently available 

10 from the Federal, State, and local governments, pri11 vate sector entities, industry, hospitals, and aca12 demia to meet the homeland security mission. 

13 (3) The deficiencies in assets and resources 

14 needed to respond to such an attack or outbreak. 

15 (4) Recommendations regarding the types and 

16 extent of assets and resources needed to be secured 

17 to respond to such an attack or outbreak, including 

18 those requested from State and local public health 

19 agencies and their volunteer responders. 

20 (b) CONTENT.—The report described in subsection 

21 (a) shall assess and make recommendations with regard 

22 to— 

23 (1) the appropriate roles and responsibilities in 

24 responding to a medical emergency of— 

25 (A) full-time government employees; 
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1 (B) part-time personnel; and 

2 (C) volunteer personnel; 

3 (2) the appropriate skills and skilled workers 

4 needed, including physicians (including infectious 

5 diseases specialists), other health care personnel, 

6 and first responders; 

7 (3) the appropriate planning and training need8 ed prior to an attack or outbreak; 

9 (4) the appropriate contingency plans for re10 sponding to a novel or catastrophic incident; and 

11 (5) mechanisms to— 

12 (A) develop and pilot test strategies to be 

13 used to reduce disease transmission in a bioter14 rorism incident, a public health emergency, or 

15 an epidemic or pandemic; 

16 (B) develop and validate meaningful na17 tional standards for Federal, State, and local 

18 public health agencies and for nongovernmental 

19 healthcare delivery institutions in preparedness 

20 for and response to epidemics, pandemics, and 

21 mass casualty incidents; 

22 (C) test these methods in State, local, and 

23 multi-State proof-of-concept tests; and 
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1 (D) develop public risk communication 

2 tools that support the widespread use of such 

3 activities. 

4 (c) CONSULTATION.—In preparing this report, the 

5 Assistant Secretary for Medical Readiness and Response 

6 of the Department of Homeland Security shall consult 

7 with the members of the National Emergency Prepared8 ness and Response Board. 

9 (d) SUBMISSION DATE.—The report shall be sub10 mitted to Congress not later than 1 year after the date 

11 of enactment of this Act. 

12 TITLE XIV—CONSTRUCTION OF 

13 SPECIALIZED RESEARCH FA14 CILITIES FOR THE DEVELOP15 MENT OF COUNTER16 MEASURES 

17 SEC. 1401. CONSTRUCTION OF SPECIALIZED RESEARCH FA18 CILITIES FOR THE DEVELOPMENT OF COUN19 TERMEASURES. 

20 (a) IN GENERAL.—Part B of title III of the Public 

21 Health Service Act (42 U.S.C. 243 et seq.) (as amended 

22 by sections 202, 1901, 2101, and 2102) is amended by 

23 inserting after section 319F–6 (as added by section 2102) 

24 the following: 
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1 ‘‘SEC. 319F–7. CONSTRUCTION OF BIOSAFETY LEVEL 3–4 RE2 SEARCH FACILITIES. 

3 ‘‘(a) FINDINGS.—Congress finds that— 

4 ‘‘(1) research to develop countermeasures re5 quires the use of special facilities where biological 

6 and chemical agents can be handled safely both for 

7 laboratory research and efficacy testing in animal 

8 models; 

9 ‘‘(2) very few companies and very few State and 

10 local public health laboratories have sufficient funds 

11 for the construction of these special facilities; and 

12 ‘‘(3) the Federal Government can facilitate re13 search and development of countermeasures by fi14 nancing the construction of these special facilities. 

15 ‘‘(b) GRANTS AUTHORIZED.— 

16 ‘‘(1) IN GENERAL.—The Secretary is authorized 

17 to award grants and contracts to grantees to con18 struct, maintain, and manage (including funding for 

19 staff and staff training) biosafety level 3–4 facilities. 

20 ‘‘(2) REQUIREMENTS.—To be eligible for a 

21 grant under paragraph (1) an entity shall— 

22 ‘‘(A) allow use of the facility involved by 

23 only those researchers who meet qualifications 

24 set by the Secretary; 

25 ‘‘(B) give priority for the use of the facility 

26 involved to those entities that have been reg-
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1 istered and certified by the Secretary to develop 

2 countermeasures; and 

3 ‘‘(C) allow the National Institutes of 

4 Health and the Centers for Disease Control and 

5 Prevention to inspect the facility involved at 

6 any time. 

7 ‘‘(3) NUMBER OF GRANTS.—The Secretary of 

8 Homeland Security shall determine the number of 

9 facilities that need to be constructed under this sec10 tion, not to exceed 10 such facilities nationwide, and 

11 the Secretary shall award grants based on such de12 termination. 

13 ‘‘(c) APPLICATION.— 

14 ‘‘(1) IN GENERAL.—To be eligible to receive a 

15 grant under this section, an entity shall submit to 

16 the Secretary an application at such time, in such 

17 form, and containing such information as the Sec18 retary may require. 

19 ‘‘(2) CONTENTS.—Each application submitted 

20 pursuant to paragraph (1) shall— 

21 ‘‘(A) provide detailed information on the 

22 technical specifications of proposed facilities; 

23 ‘‘(B) propose a design that includes offices 

24 for personnel, visiting researchers, and facilities 

25 for research and laboratory materials; and 
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1 ‘‘(C) provide assurances that— 

2 ‘‘(i) the facilities shall be available on 

3 a fee-for-service or other basis to compa4 nies and academic researchers; 

5 ‘‘(ii) such services offered to compa6 nies and academic researchers shall include 

7 testing and validation studies for all types 

8 of countermeasures, including detection 

9 technology; 

10 ‘‘(iii) such facilities shall utilize the 

11 research tools identified by the Secretary 

12 in section 319F–3 of this Act or certified 

13 under section 301(b)(4) of the Project Bio14 Shield II Act of 2005; and 

15 ‘‘(iv) that the facilities will be con16 structed as secure facilities. 

17 ‘‘(d) DEFINITIONS.—For the purposes of this sec18 tion— 

19 ‘‘(1) unless otherwise specifically identified, the 

20 term ‘Director’ means the Director of the National 

21 Institutes of Health; 

22 ‘‘(2) the term ‘biosafety level 3 facility’ means 

23 a facility described in section 627.15 of title 32, 

24 Code of Federal Regulations (or any successor regu25 lation); and 
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1 ‘‘(3) the term ‘biosafety level 4 facility’ means 

2 a facility described in section 627.16 of title 32, 

3 Code of Federal Regulation (or any successor regu4 lation). 

5 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

6 are authorized to be appropriated such sums as may be 

7 necessary to carry out this section.’’. 

8 (b) NEEDS ASSESSMENT.—The Secretary of Health 

9 and Human Services shall conduct a study of regional and 

10 national laboratory capacities with respect to the labora11 tories described in section 319F–7 of the Public Health 

12 Service Act (as added by this title) before implementing 

13 such section. 

14 TITLE XV—BIODEFENSE AND IN15 FECTIOUS DISEASE RE16 SEARCH AND SCIENTIFIC AND 

17 TECHNICAL PERSONNEL 

18 SEC. 1501. ESTABLISHMENT OF GRANT PROGRAM. 

19 Part B of title IV of the Public Health Service Act 

20 (42 U.S.C. 284 et seq.) is amended by adding at the end 

21 the following: 

22 ‘‘SEC. 409J. GRANTS FOR BIODEFENSE AND INFECTIOUS 

23 DISEASE RESEARCH. 

24 ‘‘(a) IN GENERAL.—The Director of the Centers for 

25 Disease Control and Prevention (referred in this section 
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1 as the ‘Director’), in consultation with the Assistant Sec2 retary for Medical Readiness and Response of the Depart3 ment of Homeland Security, and the Secretary of Defense 

4 shall establish a program to award grants and scholar5 ships to eligible entities to ensure that sufficient scientific 

6 and technical personnel are available to conduct biodefense 

7 and infectious disease research. 

8 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

9 or scholarship under subsection (a), an entity shall— 

10 ‘‘(1) be— 

11 ‘‘(A) an individual who desires to acquire 

12 a scientific or technical skill identified and list13 ed by the Director under subsection (c)(1)(A); 

14 or 

15 ‘‘(B) a facility or institution that is des16 ignated as a scientific or technical skills facility 

17 under subsection (c)(1)(B); and 

18 ‘‘(2) submit to the Director an application, at 

19 such time, in such manner, and containing such in20 formation as the Director may require. 

21 ‘‘(c) IDENTIFICATION OF SCIENTIFIC AND TECH22 NICAL SKILLS SHORTAGES.— 

23 ‘‘(1) ASSESSMENT AND DESIGNATION.— 

24 ‘‘(A) IN GENERAL.—Not later than 1 year 

25 after the date of enactment of this section, and 
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1 annually thereafter, the Director shall, for pur2 poses of this section, assess the science and 

3 technical skills that are needed for the develop4 ment of medical countermeasures to biological, 

5 chemical, nuclear, radiological, and other 

6 emerging natural and terrorists threats and in7 fectious diseases, including the expertise needed 

8 concerning the identification of drugs, detection 

9 equipment, diagnostics, and research tools with 

10 respect to such countermeasures. Upon comple11 tion of such assessment, the Director shall pub12 lish a list of the scientific and technical skills so 

13 identified and for which there exists a shortage 

14 of qualified individuals. 

15 ‘‘(B) FACILITIES.—Not later than 1 year 

16 after the date of enactment of this section, and 

17 annually thereafter, the Director shall designate 

18 public or nonprofit private facilities or institu19 tions that the Director determines provides edu20 cation or training with respect to a scientific or 

21 technical skill identified and published on the 

22 list under subparagraph (A). 

23 ‘‘(2) LIMITATION ON REMOVAL FROM LIST OR

24 DESIGNATION.—The Director shall not remove a 

25 skill from the list under paragraph (1)(A) or a des-
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1 ignation with respect to a facility or institution 

2 under paragraph (1)(B) unless the Director has af3 forded interested persons and groups an opportunity 

4 to provide data and information in support of the 

5 listing or designation involved, and has made a de6 termination on the basis of the data and information 

7 submitted by such persons and groups and other 

8 data and information available to the Director. 

9 ‘‘(3) CRITERIA.—The Director shall establish 

10 by regulation criteria for the listing of skills or des11 ignation of facilities and institutions under para12 graph (1). 

13 ‘‘(4) NOTICE.—The Director shall give written 

14 notice of the listing of a skill or designation of a fa15 cility or institution not later than 60 days from the 

16 date of such designation, to— 

17 ‘‘(A) the Governor of each State and offi18 cial of each local city or town in which the facil19 ity or institution so designated is in whole or 

20 part located; and 

21 ‘‘(B) appropriate public or nonprofit pri22 vate entities which provide education or train23 ing in the skills so listed. 

24 ‘‘(5) RECOMMENDED DESIGNATION.—Any per25 son may recommend to the Director the listing or a 
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1 skill or designation of a facility or other institution 

2 under paragraph (1). 

3 ‘‘(6) DISSEMINATION OF CRITERIA.—The Di4 rector shall disseminate information concerning the 

5 criteria described in paragraph (3) to— 

6 ‘‘(A) the Governor of each State; 

7 ‘‘(B) the representative of any facility se8 lected by any such Governor to receive such in9 formation; 

10 ‘‘(C) the representative of any facility that 

11 requests such information; and 

12 ‘‘(D) the representative of any facility de13 termined by the Director to be likely to meet 

14 such criteria. 

15 ‘‘(d) USE OF FUNDS.— 

16 ‘‘(1) SCHOLARSHIPS.— 

17 ‘‘(A) IN GENERAL.—Amounts provided to 

18 an individual under a scholarship under sub19 section (a) shall be used to obtain education 

20 leading to a degree or postdoctoral training at 

21 a nonprofit institution determined appropriate 

22 by the Secretary to further the development of 

23 medical countermeasures to biological, chemical, 

24 nuclear, radiological, and other emerging terror25 ists threats and infectious diseases, including 
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1 the expertise needed concerning the identifica2 tion and development of drugs, detection equip3 ment, human and animal remains handling and 

4 containment equipment and methods, 

5 diagnostics, and research tools with respect to 

6 such countermeasures. 

7 ‘‘(B) AGREEMENT TO SERVE.—To be eligi8 ble to receive a scholarship described in sub9 paragraph (A), an individual shall agree to 

10 enter into contract with the Director for obli11 gated service as provided for in subparagraph 

12 (C). 

13 ‘‘(C) OBLIGATED SERVICE.—An individual 

14 who has entered into a written contract with 

15 the Director under subparagraph (B) shall con16 duct countermeasures research on a full-time 

17 basis in an area determined appropriate by the 

18 Director for the period of obligated service pro19 vided for in such contract. 

20 ‘‘(D) PERIOD OF SERVICE.—The period of 

21 obligated service under a contract under sub22 paragraph (B) shall be equal to the greater 

23 of— 
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1 ‘‘(i) 1 year for each school year for 

2 which the individual was provided a schol3 arship under subsection (a); or 

4 ‘‘(ii) 2 years. 

5 ‘‘(E) BREACH OF CONTRACT.—The provi6 sions of section 338E shall apply to a breach of 

7 contract under this paragraph to the same ex8 tent that such provisions apply to a breach of 

9 a scholarship contract under such section. 

10 ‘‘(2) TRANSITION TO WORKFORCE.—The Direc11 tor is authorized to provide assistance to Federal 

12 agencies to incorporate the individuals who receive a 

13 grant under this section into the Federal workforce, 

14 including non-tenured positions that could transition 

15 into permanent positions at the end of the payback 

16 period. 

17 ‘‘(3) GRANTS.—Amounts awarded under a 

18 grant under subsection (a) shall be used for activi19 ties that facilitate the conduct of countermeasures 

20 research. 

21 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

22 is authorized to be appropriated to carry out this section, 

23 such sums as may be necessary.’’. 
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1 TITLE XVI—NATIONAL 

2 INSTITUTES OF HEALTH 

3 Subtitle A—National Center for 

4 Healthcare Technology Develop5 ment 

6 SEC. 1601. PURPOSE. 

7 The purpose of this subtitle is to enhance the licens8 ing of research, and protect the value of intellectual prop9 erty, funded by the National Institutes of Health to com10 panies to develop healthcare technologies for the benefit 

11 of patients. 

12 SEC. 1602. NATIONAL CENTER FOR HEALTHCARE TECH13 NOLOGY DEVELOPMENT. 

14 (a) IN GENERAL.—Part E of title IV of the Public 

15 Health Service Act (42 U.S.C. 287 et seq.) is amended 

16 by adding at the end the following: 

17 ‘‘SUBPART 7—NATIONAL CENTER FOR HEALTHCARE

18 TECHNOLOGY DEVELOPMENT

19 ‘‘SEC. 485K. NATIONAL CENTER FOR HEALTH CARE TECH20 NOLOGY DEVELOPMENT. 

21 ‘‘(a) DEFINITION.—In this subpart, the term 

22 ‘healthcare technology development program’ means a pro23 gram designed to— 

24 ‘‘(1) maximize the technology development op25 portunities and the return on the investment of the 
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1 Federal Government in research related to the devel2 opment of human diagnostics, therapeutics, anti3 microbials, vaccines, and research tools so that this 

4 investment provides clinical benefits to individuals; 

5 ‘‘(2) ensure that research supported by the 

6 Federal Government is complimentary to, and not 

7 duplicative of or competitive with, private sector re8 search; 

9 ‘‘(3) speed the development of biomedical re10 search enabling human diagnostics, therapeutics, 

11 vaccines, and research tools; and 

12 ‘‘(4) reduce the time and cost necessary for the 

13 development of human diagnostics, therapeutics, vac14 cines, and research tools. 

15 ‘‘(b) ESTABLISHMENT; PURPOSE.— 

16 ‘‘(1) ESTABLISHMENT.—There is established 

17 within the National Institutes of Health a National 

18 Center for Healthcare Technology Development (re19 ferred to in this subpart as the ‘Center’). 

20 ‘‘(2) PURPOSE.—The purpose of the Center is 

21 to increase and support healthcare technology devel22 opment, which includes— 

23 ‘‘(A) maximizing the technology develop24 ment opportunities and the return on the in25 vestment of the Federal Government in re-
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1 search related to the development of human 

2 diagnostics, therapeutics, vaccines, and research 

3 tools so that this investment provides clinical 

4 benefits to individuals; 

5 ‘‘(B) ensuring that research supported by 

6 the Federal Government is complimentary to, 

7 and not duplicative of or competitive with, pri8 vate sector research; 

9 ‘‘(C) speeding the development of bio10 medical research enabling human diagnostics, 

11 therapeutics, vaccines, and research tools; and 

12 ‘‘(D) reducing the cost and time necessary 

13 for the development of human diagnostics, 

14 therapeutics, vaccines, and research tools. 

15 ‘‘(c) DIRECTOR.— 

16 ‘‘(1) IN GENERAL.—The Center shall be headed 

17 by a Center Director (referred to in this section as 

18 the ‘Center Director’) appointed by the President by 

19 and with the advice and consent of the Senate. 

20 ‘‘(2) COMPENSATION.—The Center Director 

21 shall be compensated at a rate that is the greater 

22 of— 

23 ‘‘(A) the average total compensation of the 

24 directors of the national research institutes; or 

25 ‘‘(B) level IV of the Executive Schedule. 
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1 ‘‘(3) DUTIES OF THE CENTER DIRECTOR.—The 

2 Center Director shall perform functions as described 

3 under this subpart and as the Secretary and the Di4 rector of NIH determine appropriate. 

5 ‘‘(d) ASSOCIATE DIRECTOR.— 

6 ‘‘(1) IN GENERAL.—There shall be in the Cen7 ter an Associate Director for Biological, Chemical, 

8 Radiological, and Infectious Disease Countermeasure 

9 Development (referred to in this section as the ‘As10 sociate Director’), who shall be appointed by the 

11 Center Director. 

12 ‘‘(2) DUTIES OF THE ASSOCIATE DIRECTOR.— 

13 The Associate Director shall— 

14 ‘‘(A) serve as a liaison between the Depart15 ment of Health and Human Services, the Na16 tional Institutes of Health, the Department of 

17 Homeland Security, and the Department of De18 fense on matters relating to the development of 

19 biomedical technologies that enable effective 

20 countermeasures to bioterror, chemical, and ra21 diological agents and infectious diseases; 

22 ‘‘(B) ensure that the National Institutes of 

23 Health supports research that is consistent 

24 with, and supportive of, the joint strategy for 

25 the development of countermeasures for bio-
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1 terror, chemical, and radiological agents and in2 fectious diseases of the Department of Home3 land Security, the Department of Health and 

4 Human Services, and the Department of De5 fense; and 

6 ‘‘(C) annually review the effectiveness of 

7 the technology transfer policies and practices of 

8 the National Institutes of Health with respect 

9 to the development of countermeasures for bio10 terror, chemical, and radiological agents and in11 fectious diseases to ensure that the policies and 

12 practices are consistent with the joint counter13 measure development strategy of the Depart14 ment of Homeland Security, the Department of 

15 Health and Human Services, and the Depart16 ment of Defense. 

17 ‘‘(e) DUTIES OF THE CENTER.—The Center shall— 

18 ‘‘(1) manage the technology transfer, partner19 ship, and healthcare technology development pro20 grams at the National Institutes of Health; 

21 ‘‘(2) oversee the healthcare technology develop22 ment programs of the grantees of the National Insti23 tutes of Health; 
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1 ‘‘(3) secure and license intellectual property for 

2 research performed at the National Institutes of 

3 Health; 

4 ‘‘(4) prepare, on an annual basis, the National 

5 Healthcare Technology Development Strategy re6 garding the technology transfer, partnership, and 

7 healthcare technology development programs of the 

8 National Institutes of Health and the grantees of 

9 the National Institutes of Health; 

10 ‘‘(5) with regard to the Healthcare Technology 

11 Development Opportunities Assessments under sec12 tion 492A— 

13 ‘‘(A) establish criteria for the contents of 

14 the assessments; 

15 ‘‘(B) assist National Institutes of Health 

16 applicants in preparing the assessments; 

17 ‘‘(C) assist the Directors of the national 

18 research institutes in reviewing the assess19 ments; 

20 ‘‘(D) prepare periodic analyses of the con21 tents of the assessments; and 

22 ‘‘(E) prepare periodic analyses of the ex23 tent to which the opportunities were realized; 

24 ‘‘(6) in consultation with the Directors of the 

25 national research institutes, the National Advisory 
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1 Council under subsection (f) and the Institute Advi2 sory Councils under subsection (g), prepare a re3 search agenda for the National Institutes of Health, 

4 and for each national research institute, that de5 scribes— 

6 ‘‘(A) the technology development opportu7 nities and the research that would be most ben8 eficial to enhancing the return on the invest9 ment of the Federal Government in developing 

10 human diagnostics, therapeutics, vaccines, and 

11 research tools, so that this investment provides 

12 clinical benefits to individuals; 

13 ‘‘(B) the research supported by the Fed14 eral Government that is complimentary to, and 

15 not duplicative of or competitive with, private 

16 sector research; 

17 ‘‘(C) proposed measures designed to speed 

18 the development of human diagnostics, thera19 peutics, vaccines, and research tools; and 

20 ‘‘(D) proposed measures designed to re21 duce the cost and time necessary to develop 

22 human diagnostics, therapeutics, vaccines, and 

23 research tools; 

24 ‘‘(7) publish a technology transfer, partnership, 

25 and healthcare technology development manual that 
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1 describes the most effective healthcare technology 

2 development policies and practices for the National 

3 Institutes of Health and its grantees that maximize 

4 the technology development opportunities and the re5 turn on the investment of the Federal Government 

6 in research to the development of healthcare tech7 nology; 

8 ‘‘(8) collect and analyze comprehensive data re9 garding the effectiveness of the technology transfer, 

10 partnerships, and healthcare technology development 

11 programs of the National Institutes of Health and 

12 its grantees that maximize the technology develop13 ment opportunities and the return on the investment 

14 of the Federal Government in research to the devel15 opment of healthcare technology, including data re16 garding— 

17 ‘‘(A) intellectual property; 

18 ‘‘(B) licensing and commercialization of in19 ventions sponsored by the National Institutes of 

20 Health; 

21 ‘‘(C) cooperative research and development 

22 agreements; and 

23 ‘‘(D) technology development opportunities 

24 assessments under section 492A(a); 
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1 ‘‘(9) develop guidelines that enable the National 

2 Institutes of Health to accept and divest economic 

3 interests in commercial entities that enter into tech4 nology transfer, licensing, and partnership relation5 ships with the National Institutes of Health; 

6 ‘‘(10) accept payment for services, use of equip7 ment, materials, or laboratory personnel, and retain 

8 or transfer those funds to the appropriate labora9 tories; 

10 ‘‘(11) ensure that Small Business Innovative 

11 Research (SBIR) and Small Business Technology 

12 Transfer Program (STTR) grants under section 9 of 

13 the Small Business Act (15 U.S.C. 638) are award14 ed to entities that have the greatest capacity to de15 velop healthcare technology that provides clinical 

16 benefits to individuals; 

17 ‘‘(12) oversee the review of SBIR and STTR 

18 grants; 

19 ‘‘(13) annually award the ‘Birch Bayh and 

20 Robert Dole Award for Healthcare Partnerships’ to 

21 the individual and to the organization that has made 

22 the most significant contribution with regard to— 

23 ‘‘(A) maximizing the technology develop24 ment opportunities and the return on the in25 vestment of the Federal Government in re-
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1 search related to the development of human 

2 diagnostics, therapeutics, vaccines, and research 

3 tools so that this investment provides clinical 

4 benefits to individuals; 

5 ‘‘(B) ensuring that research supported by 

6 the Federal Government is complimentary to, 

7 and not duplicative of or competitive with, pri8 vate sector research; 

9 ‘‘(C) speeding the development of bio10 medical research enabling human diagnostics, 

11 therapeutics, vaccines, and research tools; and 

12 ‘‘(D) reducing the time and cost necessary 

13 to develop human diagnostics, therapeutics, vac14 cines, and research tools; 

15 ‘‘(14) annually award the ‘Ronald Reagan and 

16 Morris Udall Award for Healthcare Technology De17 velopment’ to the individual scientist supported by 

18 the National Institutes of Health that has made the 

19 most significant contribution to the development of 

20 healthcare technology that provides clinical benefits 

21 to individuals; 

22 ‘‘(15) provide grants to private organizations 

23 with expertise in technology transfer, partnerships, 

24 and healthcare technology development programs; 
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1 ‘‘(16) manage an education program for Na2 tional Institutes of Health and private sector entity 

3 employees and grantees on the role of the National 

4 Institutes of Health concerning the development of 

5 healthcare technology; and 

6 ‘‘(17) manage the advisory councils under sub7 sections (f) and (g). 

8 ‘‘(f) NATIONAL ADVISORY COUNCIL.— 

9 ‘‘(1) ESTABLISHMENT.—The Secretary shall es10 tablish in the Center an advisory council to be 

11 known as the National Healthcare Technology De12 velopment Advisory Council (referred to in this sub13 section as the ‘National Advisory Council’). 

14 ‘‘(2) COMPOSITION.— 

15 ‘‘(A) IN GENERAL.—The National Advi16 sory Council shall be composed of 13 members 

17 to be appointed in accordance with subpara18 graph (B) and subject to subparagraphs (C), 

19 (D), (E), and (F). 

20 ‘‘(B) APPOINTMENT; BACKGROUND.— 

21 ‘‘(i) APPOINTMENT.—Not later than 

22 180 days after the effective date of the 

23 Project BioShield II Act of 2005, the Di24 rector of NIH shall appoint the members 

25 of the National Advisory Council. 
213 

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1 ‘‘(ii) BACKGROUND.—Of the members 

2 appointed under clause (i)— 

3 ‘‘(I) not less than 9 members 

4 shall be executive officers of bio5 technology, pharmaceutical, diag6 nostic, and research tool companies 

7 that are currently developing or com8 mercializing healthcare technology; 

9 ‘‘(II) not less than 3 members 

10 shall be executive offices of small busi11 ness interests; and 

12 ‘‘(III) the remaining members 

13 may include investors and investment 

14 company executives, securities ana15 lysts, experts in the economics of bio16 medical research and development, ex17 perts in intellectual property and tech18 nology transfer, Food and Drug Ad19 ministration regulations, licenses, 

20 partnerships, and technology transfer 

21 officers of grantees of the National 

22 Institutes of Health. 

23 ‘‘(C) INSTITUTE ADVISORY COUNCILS.—A 

24 member of the National Advisory Council shall 
214 

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1 not serve as a member of an Institute Advisory 

2 Council under subsection (g). 

3 ‘‘(D) EX OFFICIO MEMBERS.— 

4 ‘‘(i) IN GENERAL.—The Secretary of 

5 Commerce, the Director of the National 

6 Science Foundation, and the Director of 

7 the National Institute of Standards and 

8 Technology shall serve as ex officio mem9 bers of the National Advisory Council. 

10 ‘‘(ii) DESIGNEES.—The officers listed 

11 in clause (i) may appoint a designee to 

12 perform their functions on the National 

13 Advisory Council. 

14 ‘‘(E) CHAIRPERSON.—The Director of 

15 NIH shall appoint a chairperson of the Na16 tional Advisory Council from among the council 

17 members. 

18 ‘‘(F) VACANCY.—Any vacancy in the Na19 tional Advisory Council shall not affect the pow20 ers of the Council and shall be filled in the 

21 same manner as the original appointment. 

22 ‘‘(3) DUTIES OF THE NATIONAL ADVISORY

23 COUNCIL.—The National Advisory Council shall ad24 vise the Center Director regarding policies and pro25 cedures that will— 
215 

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1 ‘‘(A) maximize the technology development 

2 opportunities and the return on the investment 

3 of the Federal Government in research related 

4 to the development of human diagnostics, thera5 peutics, vaccines, and research tools so that this 

6 investment provides clinical benefits to individ7 uals; 

8 ‘‘(B) ensure that research supported by the 

9 Federal Government is complimentary to, and 

10 not duplicative of or competitive with, private 

11 sector research; 

12 ‘‘(C) speed the development of biomedical 

13 research into effective human diagnostics, 

14 therapeutics, vaccines, and research tools; and 

15 ‘‘(D) reduce the cost and time needed for 

16 the development of human diagnostics, thera17 peutics, vaccines, and research tools. 

18 ‘‘(4) POWERS.— 

19 ‘‘(A) HEARINGS.—The National Advisory 

20 Council may hold such hearings, sit and act at 

21 such times and places, take such testimony, and 

22 receive such evidence as the National Advisory 

23 Council considers advisable to carry out this 

24 section. 
216 

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1 ‘‘(B) INFORMATION FROM FEDERAL AGEN2 CIES.—The National Advisory Council may se3 cure directly from any Federal department or 

4 agency such information as the National Advi5 sory Council considers necessary to carry out 

6 the provisions of this section. Upon request of 

7 the National Advisory Council, the head of such 

8 department or agency shall furnish such infor9 mation to the National Advisory Council. 

10 ‘‘(C) POSTAL SERVICES.—The National 

11 Advisory Council may use the United States 

12 mails in the same manner and under the same 

13 conditions as other departments and agencies of 

14 the Federal Government. 

15 ‘‘(5) PERSONNEL.— 

16 ‘‘(A) TRAVEL EXPENSES.—The members 

17 of the National Advisory Council shall not re18 ceive compensation for the performance of serv19 ices for the National Advisory Council, but shall 

20 be allowed travel expenses, including per diem 

21 in lieu of subsistence, at rates authorized for 

22 employees of agencies under subchapter I of 

23 chapter 57 of title 5, United States Code, while 

24 away from their homes or regular places of 

25 business in the performance of services for the 
217 

S 975 IS 

1 National Advisory Council. Notwithstanding 

2 section 1342 of title 31, United States Code, 

3 the Secretary may accept the voluntary and un4 compensated services of members of the Na5 tional Advisory Council. 

6 ‘‘(B) DETAIL OF GOVERNMENT EMPLOY7 EES.—Any Federal Government employee may 

8 be detailed to the National Advisory Council 

9 without reimbursement, and such detail shall be 

10 without interruption or loss of civil service sta11 tus or privilege. 

12 ‘‘(g) INSTITUTE ADVISORY COUNCILS.— 

13 ‘‘(1) ESTABLISHMENT.—The Secretary shall es14 tablish in the Center the National Center for 

15 Healthcare Technology Development Institute Advi16 sory Councils (referred to in this subsection as the 

17 ‘Institute Advisory Councils’). 

18 ‘‘(2) COMPOSITION.— 

19 ‘‘(A) IN GENERAL.—Each Institute Advi20 sory Council shall be composed of 13 members 

21 appointed in accordance with subparagraph (B) 

22 and subject to subparagraphs (C), (D), (E), 

23 and (F). 

24 ‘‘(B) APPOINTMENT; BACKGROUND.— 
218 

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1 ‘‘(i) APPOINTMENT.—Not later than 

2 180 days after the effective date of the 

3 Project BioShield II Act of 2005, the ap4 propriate Institute Director shall appoint 

5 the members of the respective Institute 

6 Advisory Council. 

7 ‘‘(ii) BACKGROUND.—Of the members 

8 appointed under clause (i)— 

9 ‘‘(I) at least 9 members shall be 

10 executive officers of biotechnology, 

11 pharmaceutical, diagnostic, and re12 search tool companies that are cur13 rently developing or commercializing 

14 healthcare technology; and 

15 ‘‘(II) the remaining members 

16 shall include investors and investment 

17 company executives, securities ana18 lysts, experts in the economics of bio19 medical research and development, ex20 perts in intellectual property and tech21 nology transfer, Food and Drug Ad22 ministration regulations, licenses, 

23 partnerships, and technology transfer 

24 officers of grantees of the National 

25 Institutes of Health. 
219 

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1 ‘‘(C) NATIONAL ADVISORY COUNCIL.—A 

2 member of an Institute Advisory Council shall 

3 not serve as a member of the National Advisory 

4 Council under subsection (f). 

5 ‘‘(D) EX OFFICIO MEMBER.—The Center 

6 Director, or his or her designee, shall serve as 

7 an ex officio member of the Institute Advisory 

8 Councils. 

9 ‘‘(E) CHAIRPERSON.—The appropriate In10 stitute Director shall appoint a chairperson of 

11 the respective Institute Advisory Council from 

12 among the council members. 

13 ‘‘(F) VACANCIES.—Any vacancy in an In14 stitute Advisory Council shall not affect the 

15 powers of the Council and shall be filled in the 

16 same manner as the original appointment. 

17 ‘‘(3) DUTIES OF THE INSTITUTE ADVISORY

18 COUNCIL.—The Institute Advisory Councils shall ad19 vise the Center Director regarding policies and pro20 cedures that will— 

21 ‘‘(A) maximize the technology development 

22 opportunities and the return on the investment 

23 of the Federal Government in research related 

24 to the development of human diagnostics, thera25 peutics, vaccines, and research tools so that this 
220 

S 975 IS 

1 investment provides clinical benefits to individ2 uals; 

3 ‘‘(B) ensure that research supported by the 

4 Federal Government is complimentary to, and 

5 not duplicative of or competitive with, private 

6 sector research; 

7 ‘‘(C) speed the development of biomedical 

8 research into human diagnostics, therapeutics, 

9 vaccines, and research tools; and 

10 ‘‘(D) reduce the cost and time needed for 

11 the development of human diagnostics, thera12 peutics, vaccines, and research tools. 

13 ‘‘(4) POWERS.— 

14 ‘‘(A) HEARINGS.—The Institute Advisory 

15 Councils may hold such hearings, sit and act at 

16 such times and places, take such testimony, and 

17 receive such evidence as the Institute Advisory 

18 Council considers advisable to carry out this 

19 section. 

20 ‘‘(B) INFORMATION FROM FEDERAL AGEN21 CIES.—The Institute Advisory Councils may se22 cure directly from any Federal department or 

23 agency such information as the Institute Advi24 sory Council considers necessary to carry out 

25 the provisions of this section. Upon request of 
221 

S 975 IS 

1 an Institute Advisory Council, the head of such 

2 department or agency shall furnish such infor3 mation to the Institute Advisory Council. 

4 ‘‘(C) POSTAL SERVICES.—The Institute 

5 Advisory Councils may use the United States 

6 mails in the same manner and under the same 

7 conditions as other departments and agencies of 

8 the Federal Government. 

9 ‘‘(5) PERSONNEL.— 

10 ‘‘(A) TRAVEL EXPENSES.—The members 

11 of the Institute Advisory Councils shall not re12 ceive compensation for the performance of serv13 ices for the Institute Advisory Councils, but 

14 shall be allowed travel expenses, including per 

15 diem in lieu of subsistence, at rates authorized 

16 for employees of agencies under subchapter I of 

17 chapter 57 of title 5, United States Code, while 

18 away from their homes or regular places of 

19 business in the performance of services for the 

20 Institute Advisory Councils. Notwithstanding 

21 section 1342 of title 31, United States Code, 

22 the Secretary may accept the voluntary and un23 compensated services of members of the Insti24 tute Advisory Council. 
222 

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1 ‘‘(B) DETAIL OF GOVERNMENT EMPLOY2 EES.—Any Federal Government employee may 

3 be detailed to an Institute Advisory Council 

4 without reimbursement, and such detail shall be 

5 without interruption or loss of civil service sta6 tus or privilege. 

7 ‘‘(h) TRAINEESHIPS; FELLOWSHIPS.— 

8 ‘‘(1) IN GENERAL.—The Secretary, acting 

9 through the Center Director, may— 

10 ‘‘(A) provide research training and instruc11 tion in technology transfer and healthcare com12 mercialization transfer, licenses, partnerships, 

13 and healthcare technology development; and 

14 ‘‘(B) establish research traineeships and 

15 fellowships in technology transfer and 

16 healthcare commercialization. 

17 ‘‘(2) STIPENDS AND ALLOWANCES.—The Sec18 retary may provide individuals receiving instruction, 

19 a traineeship, or fellowship under paragraph (1) 

20 with such stipends and allowances, including 

21 amounts for travel, subsistence, and dependents, as 

22 the Secretary determines necessary. 

23 ‘‘(3) EMPLOYEE DETAIL.—The Secretary shall 

24 establish guidelines for the temporary leave, for a 

25 period of not to exceed 3 years, of not more than 
223 

S 975 IS 

1 220 employees of the National Institutes of Health, 

2 to appropriate for-profit organizations that are in 

3 the business of developing human therapeutics, vac4 cines, devices, or diagnostics and research tools. 

5 ‘‘(i) GRANTS.— 

6 ‘‘(1) IN GENERAL.—The Secretary, acting 

7 through the Center Director, shall award grants to 

8 eligible nonprofit institutions to provide training, in9 struction, traineeships, and fellowships under sub10 section (h). 

11 ‘‘(2) USE OF FUNDS.—A nonprofit institution 

12 that receives funds under this subsection shall use 

13 the amounts provided through the grant to provide 

14 training, instruction, traineeships, and fellowships to 

15 individuals under subsection (h) with regard to tech16 nology transfer and healthcare development. 

17 ‘‘(3) ELIGIBILITY.—To be eligible for a grant 

18 under this subsection, a nonprofit institution shall 

19 submit an application to the Secretary in such form, 

20 in such manner, and containing such information as 

21 the Secretary may require. 

22 ‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—There 

23 is authorized to be appropriated an amount equal to 0.3 

24 percent of the amount obligated by the National Institutes 
224 

S 975 IS 

1 of Health in fiscal year 2004 for each fiscal year to carry 

2 out this section.’’. 

3 (b) GOVERNMENT DISCOUNT.—The Secretary of 

4 Health and Human Services and the Secretary of Vet5 erans Affairs shall ensure that the price that the Federal 

6 Government pays for a drug, biological product, human 

7 therapeutic, vaccine, or diagnostic developed using tech8 nology licensed by the National Institutes of Health does 

9 not include reimbursement for any royalty rate previously 

10 paid by the technology partner or its assign. 

11 SEC. 1603. TECHNOLOGY DEVELOPMENT OPPORTUNITIES 

12 ASSESSMENTS. 

13 Section 492A(a) of the Public Health Service Act (42 

14 U.S.C. 289a–1(a)) is amended by adding at the end the 

15 following: 

16 ‘‘(3) TECHNOLOGY DEVELOPMENT OPPORTUNI17 TIES ASSESSMENT.—Each proposal submitted to the 

18 National Institutes of Health shall include an assess19 ment, prepared in compliance with the guidelines de20 veloped by the National Center for Healthcare Tech21 nology Development, of technology development op22 portunities, including opportunities that may exist 

23 for the proposed research to— 

24 ‘‘(A) maximize the technology development 

25 opportunities and the return on the investment 
225 

S 975 IS 

1 of the Federal Government in research related 

2 to the development of human diagnostics, thera3 peutics, vaccines, and research tools so that this 

4 investment provides clinical benefits to individ5 uals; 

6 ‘‘(B) ensure that research supported by the 

7 Federal Government is complimentary to, and 

8 not duplicative of or competitive with, private 

9 sector research; 

10 ‘‘(C) speed the development of biomedical 

11 research into human diagnostics, therapeutics, 

12 vaccines, and research tools; and 

13 ‘‘(D) reduce the cost and time necessary 

14 for the development of human diagnostics, 

15 therapeutics, vaccines, and research tools.’’. 

16 SEC. 1604. RESOURCES FOR THE NATIONAL CENTER FOR 

17 HEALTHCARE TECHNOLOGY DEVELOPMENT. 

18 Section 402(b) of the Public Health Service Act (42 

19 U.S.C. 282(b)) is amended— 

20 (1) in paragraph (13)(B), by striking ‘‘and’’; 

21 (2) in paragraph (14), by striking ‘‘title 38, 

22 United States Code.’’ and inserting ‘‘title 38, United 

23 States Code; and’’; and 

24 (3) inserting after paragraph (14) the following: 
226 

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1 ‘‘(15) after consultation with the Director of 

2 the National Center for Healthcare Technology De3 velopment, shall develop programs designed to— 

4 ‘‘(A) maximize the technology development 

5 opportunities and the return on the investment 

6 of the Federal Government in research related 

7 to the development of human diagnostics, thera8 peutics, vaccines, and research tools so that this 

9 investment provides clinical benefits to individ10 uals; 

11 ‘‘(B) ensure that research supported by the 

12 Federal Government is complimentary to, and 

13 not duplicative of or competitive with, private 

14 sector research; 

15 ‘‘(C) speed the development of biomedical 

16 research into human diagnostics, therapeutics, 

17 vaccines, and research tools; and 

18 ‘‘(D) reduce the time and cost necessary 

19 for the development of human diagnostics, 

20 therapeutics, vaccines, and research tools.’’. 

21 SEC. 1605. BIENNIAL REPORT OF THE DIRECTOR OF THE 

22 NATIONAL INSTITUTES OF HEALTH TO THE 

23 PRESIDENT AND CONGRESS. 

24 Section 403 of the Public Health Service Act (42 

25 U.S.C. 283) is amended— 
227 

S 975 IS 

1 (1) in paragraph (4), by striking ‘‘area; and’’ 

2 and inserting ‘‘area;’’; 

3 (2) in paragraph (5), by striking ‘‘Nursing Re4 search.’’ and inserting ‘‘Nursing Research; and’’; 

5 and 

6 (3) by inserting after (5) the following: 

7 ‘‘(6) a description of the healthcare technology 

8 that has been developed for the clinical benefit of in9 dividuals with support by the National Institutes of 

10 Health in the preceding 2-year period and the spe11 cific contribution of research supported by the Na12 tional Institutes of Health to this technology.’’. 

13 SEC. 1606. AUTHORITY OF THE DIRECTORS OF THE NA14 TIONAL RESEARCH INSTITUTES; BIENNIAL 

15 REPORT. 

16 (a) AUTHORITY OF THE DIRECTORS OF THE NA17 TIONAL RESEARCH INSTITUTES.—Section 405(b)(1)(A) 

18 of the Public Health Service Act (42 U.S.C. 284(b)(1)(A)) 

19 is amended— 

20 (1) in clause (iii), by striking ‘‘disabilities, and’’ 

21 and inserting ‘‘disabilities,’’; 

22 (2) in clause (iv), by striking ‘‘the environ23 ment;’’ and inserting ‘‘the environment, and’’; and 

24 (3) by inserting after clause (iv) the following: 
228 

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1 ‘‘(v) the expansion of knowledge of the cre2 ation, manufacture, or administration of treat3 ments of patients suffering from diseases, dis4 orders, or disabilities; and’’. 

5 (b) BIENNIAL REPORT.—Section 407 of the Public 

6 Health Service Act (42 U.S.C. 284b) is amended to read 

7 as follows: 

8 ‘‘SEC. 407. INSTITUTE BIENNIAL REPORT. 

9 ‘‘(a) IN GENERAL.—The Director of each national re10 search institute, after consultation with the advisory coun11 cil for the institute, shall include in the biennial report 

12 made under section 403— 

13 ‘‘(1) a description of the research areas identi14 fied as most relevant to the development of tech15 nology by the National Center for Healthcare Tech16 nology Development Advisory Council; 

17 ‘‘(2) a description of the activities of the insti18 tute; 

19 ‘‘(3) a description of technology that has been 

20 developed and licensed for the clinical benefit of in21 dividuals from all research supported by the insti22 tute; and 

23 ‘‘(4) a description of program policies of the Di24 rector of the institute. 
229 

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1 ‘‘(b) ADDITIONAL REPORTS.—The Director of each 

2 national research institute may prepare such additional re3 ports as the Director determines appropriate. 

4 ‘‘(c) OPPORTUNITY FOR WRITTEN COMMENTS.—The 

5 Director of each national research institute shall provide 

6 the advisory council for the institute an opportunity for 

7 the submission of the written comments described under 

8 section 406(g).’’. 

9 SEC. 1607. COMMERCIAL RESEARCH AND INVESTIGATIONS. 

10 Section 301(a) of the Public Health Service Act (42 

11 U.S.C. 241(a)) is amended in the matter following para12 graph (8) by striking ‘‘for biomedical and behavioral re13 search, substances and living organisms’’ and inserting 

14 ‘‘for commercial, biomedical, and behavioral research, sub15 stances, resources, rights to intellectual property, and liv16 ing organisms’’. 

17 SEC. 1608. SBIR/STTR PROGRAM CONSULTATION WITH THE 

18 DIRECTOR OF THE CENTER OF HEALTHCARE 

19 TECHNOLOGY DEVELOPMENT. 

20 Section 9 of the Small Business Act (15 U.S.C. 638) 

21 is amended— 

22 (1) in subsection (g)(3)— 

23 (A) in subparagraph (A), by striking ‘‘; 

24 or’’ and inserting a semicolon; 
230 

S 975 IS 

1 (B) in subparagraph (B), by inserting ‘‘or’’ 

2 after the semicolon; and 

3 (C) by adding after subparagraph (B) the 

4 following: 

5 ‘‘(C) the Director of the National Center 

6 for Healthcare Technology Development under 

7 section 485K of the Public Health Service 

8 Act;’’; and 

9 (2) in subsection (o)(3)— 

10 (A) in subparagraph (A), by striking ‘‘; 

11 or’’ and inserting a semicolon; 

12 (B) in subparagraph (B), by inserting ‘‘or’’ 

13 after the semicolon; and 

14 (C) by inserting after subparagraph (B) 

15 the following: 

16 ‘‘(C) by the Director of the National Cen17 ter for Healthcare Technology Development 

18 under section 485K of the Public Health Serv19 ice Act;’’. 

20 SEC. 1609. PURPOSE OF THE NATIONAL RESEARCH INSTI21 TUTES. 

22 Title IV of the Public Health Service Act (42 U.S.C. 

23 281 et seq.) is amended— 

24 (1) in section 410 (42 U.S.C. 285), by inserting 

25 before the period the following: ‘‘, and the conduct 
231 

S 975 IS 

1 and support of the development of healthcare tech2 nologies’’; 

3 (2) in section 418 (42 U.S.C. 285b), by insert4 ing before the period the following: ‘‘, and the con5 duct and support of the development of healthcare 

6 technologies’’; 

7 (3) in section 426 (42 U.S.C. 285c), by insert8 ing before the period the following: ‘‘, and the con9 duct and support of the development of healthcare 

10 technologies’’; 

11 (4) in section 435 (42 U.S.C. 285d), by insert12 ing before the period the following: ‘‘, and the con13 duct and support of the development of healthcare 

14 technologies’’; 

15 (5) in section 443 (42 U.S.C. 285e), by insert16 ing before the period the following: ‘‘, and the con17 duct and support of the development of healthcare 

18 technologies’’; 

19 (6) in section 446 (42 U.S.C. 285f), by insert20 ing before the period the following: ‘‘, and the con21 duct and support of the development of healthcare 

22 technologies’’; 

23 (7) in section 448 (42 U.S.C. 285g), by insert24 ing before the period the following: ‘‘, and the con-
232 

S 975 IS 

1 duct and support of the development of healthcare 

2 technologies’’; 

3 (8) in section 453 (42 U.S.C. 285h), by insert4 ing before the period the following: ‘‘, and the con5 duct and support of the development of healthcare 

6 technologies’’; 

7 (9) in section 455 (42 U.S.C. 285i), by insert8 ing before the period the following: ‘‘, and the con9 duct and support of the development of healthcare 

10 technologies’’; 

11 (10) in section 457 (42 U.S.C. 285j), by insert12 ing before the period the following: ‘‘, and the con13 duct and support of the development of healthcare 

14 technologies’’; 

15 (11) in section 461 (42 U.S.C. 285k), by insert16 ing before the period the following: ‘‘, and the con17 duct and support of the development of healthcare 

18 technologies’’; 

19 (12) in section 463 (42 U.S.C. 285l), by insert20 ing before the period the following: ‘‘, and the con21 duct and support of the development of healthcare 

22 technologies’’; 

23 (13) in section 464 (42 U.S.C. 285m), by in24 serting before the period the following: ‘‘, and the 
233 

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1 conduct and support of the development of 

2 healthcare technologies’’; 

3 (14) in section 464H (42 U.S.C. 284n), by in4 serting before the period the following: ‘‘, and the 

5 conduct and support of the development of 

6 healthcare technologies’’; 

7 (15) in section 464L (42 U.S.C. 285o), by in8 serting before the period the following: ‘‘, and the 

9 conduct and support of the development of 

10 healthcare technologies’’; 

11 (16) in section 464R (42 U.S.C. 285p), by in12 serting before the period the following: ‘‘, and the 

13 conduct and support of the development of 

14 healthcare technologies’’; 

15 (17) in section 464V (42 U.S.C. 285q), by in16 serting before the period the following: ‘‘, and the 

17 conduct and support of the development of 

18 healthcare technologies’’; and 

19 (18) in section 464Z (42 U.S.C. 285r), by in20 serting before the period the following: ‘‘, and the 

21 conduct and support of the development of 

22 healthcare technologies’’. 
234 

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1 SEC. 1610. CONFORMING AMENDMENT. 

2 Section 401(b)(1) of the Public Health Service Act 

3 (42 U.S.C. 281(b)(1)) is amended by adding at the end 

4 the following: 

5 ‘‘(S) The National Center for Healthcare Tech6 nology Development.’’. 

7 SEC. 1611. EFFECTIVE DATE. 

8 This title shall take effect on October 1, 2005, or 

9 upon the date of enactment of this title, whichever occurs 

10 later. 

11 Subtitle B—Protecting Government 

12 Investment in Basic Biomedical 

13 Research 

14 SEC. 1621. FINDINGS. 

15 Congress finds that— 

16 (1) the rate of return on the Federal Govern17 ment’s investment in basic biomedical research is 

18 maximized when the intellectual property for that re19 search is effectively transferred to commercial enti20 ties for development into healthcare products for the 

21 benefit of patients; 

22 (2) intellectual property for research supported 

23 by the National Institutes of Health is often not 

24 competitive with intellectual property for research 

25 supported by private investors due to inefficiencies 

26 of the technology transfer process and the con-
235 

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1 sequent erosion of the term of the patents for the 

2 technology; and 

3 (3) to protect the Federal Government’s invest4 ment in basic biomedical research and to maximize 

5 the likelihood that technology will be developed into 

6 healthcare products, a patent that is not affected by 

7 the inefficiencies in the technology transfer process 

8 should be granted. 

9 SEC. 1622. UTILIZATION AND AVAILABILITY. 

10 (a) IN GENERAL.—An entity with respect to which 

11 an affirmative determination is made under section 

12 301(b)(4) shall maximize the utilization of a research tool 

13 involved for the development of countermeasures, includ14 ing making the research tool available on commercially 

15 reasonable terms to other entities certified under section 

16 301(b)(4) to develop countermeasures. 

17 (b) RULE OF CONSTRUCTION.—Nothing in this title 

18 or chapter 18 of title 35, United States Code, shall be 

19 construed to restrict the right of an entity described in 

20 subsection (a) to— 

21 (1) secure and enforce a patent regarding a re22 search tool; 

23 (2) enter into exclusive, revocable, and non24 transferable licenses of a research tool; or 
236 

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1 (3) impose limits on royalty- or product- reach2 through or downstream rights or agreements on fu3 ture countermeasures, or option rights with respect 

4 to a research tool. 

5 SEC. 1623. RESTORATION OF TERM OF UNEXPLOITED PAT6 ENTS ON GOVERNMENT SPONSORED INVEN7 TIONS RELATING TO COUNTERMEASURES. 

8 (a) IN GENERAL.—Chapter 14 of title 35, United 

9 States Code, is amended by adding at the end the fol10 lowing: 

11 ‘‘§ 159. Patent term restoration for unexploited pat12 ents on Government sponsored inven13 tions 

14 ‘‘(a) DEFINITIONS.—In this section: 

15 ‘‘(1) ELIGIBLE GOVERNMENT-SPONSORED IN16 VENTION.—The term ‘eligible Government-supported 

17 invention’ means an invention supported in part by 

18 funds appropriated to the National Institutes of 

19 Health that may be used to produce a counter20 measure to a terror agent, infectious disease or 

21 other disease or condition or is subject to the provi22 sions of chapter 18 of title 35, United States Code. 

23 ‘‘(2) ELIGIBLE GOVERNMENT PATENT.—The 

24 term ‘eligible Government patent’ means a patent 

25 that— 
237 

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1 ‘‘(A) claims an eligible Government-sup2 ported invention; 

3 ‘‘(B) has not been extended or restored 

4 under section 156, 156a, or 158; and 

5 ‘‘(C) has not been licensed prior to a date 

6 that is 2 years before the date the patent will 

7 expire. 

8 ‘‘(3) EFFECTIVE EXPLOITATION OF DATE OF

9 THE PATENT.—The term ‘effective exploitation date 

10 of the patent’ means the date that is the later of— 

11 ‘‘(A) the date that the patent is licensed to 

12 an entity that is not a Federal agency, as that 

13 term is defined in section 201(a), for purposes 

14 of development or commercialization of the pat15 ented invention; or 

16 ‘‘(B) if the patent claims a product, a 

17 method of using a product or a method of using 

18 a product as defined in section 156(a), the date 

19 that such product is approved under section 

20 505(b)(1) of the Federal Food Drug and Cos21 metic Act (21 U.S.C. 355(b)(1)) or under sec22 tion 351 of the Public Health Service Act (42 

23 U.S.C. 262). 

24 ‘‘(b) PATENT TERM RESTORATION FOR ELIGIBLE

25 GOVERNMENT PATENTS.— 
238 

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1 ‘‘(1) IN GENERAL.—Notwithstanding the provi2 sions of section 154, the term of an eligible Govern3 ment patent shall be restored by a period equal to 

4 the number of days starting on the date that the 

5 patent is issued and ending on the date of effective 

6 exploitation date of the patent. 

7 ‘‘(2) LIMITATION.—No eligible Government pat8 ent shall be restored under this section unless— 

9 ‘‘(A) the Director of the National Insti10 tutes of Health (referred to in this section as 

11 the ‘Director of NIH’) determines that the li12 censing of such patent will assist in the develop13 ment of countermeasures, medicines, vaccines, 

14 and other technology potentially beneficial to 

15 patients; and 

16 ‘‘(B) prior to the expiration of the patent, 

17 the Director of NIH submits an application to 

18 the Director to restore the term of the patent 

19 under subsection (c). 

20 ‘‘(c) PROCEDURE FOR RESTORING TERM OF ELIGI21 BLE GOVERNMENT PATENT.— 

22 ‘‘(1) IN GENERAL.—The Director of NIH shall 

23 request restoration of an eligible Government patent 

24 by submitting a written application to the Director. 
239 

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1 ‘‘(2) CONTENTS OF APPLICATION.—An applica2 tion under this section shall— 

3 ‘‘(A) be sent to the Director prior to the 

4 date that is 45 days before the patent expires; 

5 ‘‘(B) set forth the period of the restoration 

6 requested; and 

7 ‘‘(C) provide an explanation of the basis of 

8 the conclusion of the Director of NIH that the 

9 requirements of subparagraph (A) are met with 

10 respect to the patent being restored. 

11 ‘‘(3) EFFECT OF SECTION.—The Director of 

12 NIH shall promulgate regulations to give effect to 

13 this section, including procedures that permit the 

14 restoration of patents in respect of which title has 

15 been transferred under section 202. 

16 ‘‘(d) DEFERRAL OF PAYMENT OF PATENT ISSUE

17 FEES FOR ELIGIBLE GOVERNMENT PATENTS.—The Fed18 eral agency that has rights in an invention subject to a 

19 patent application under chapter 18 may defer the pay20 ment of fees under section 41 due for issuance of an eligi21 ble Government patent until the date that is 90 days after 

22 the date that the patent been licensed to an entity that 

23 is not a Federal agency as that term is defined in section 

24 201(a). Not later than 30 days after the date a notice 

25 of allowance of the patent application is mailed by the Di-
240 

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1 rector, the applicant shall inform the Director that it is 

2 invoking this section with respect to the application. The 

3 Director shall issue the patent for the National Institutes 

4 of Health-supported technology notwithstanding the non5 payment of the issue fee, subject to the provisions of this 

6 section. 

7 ‘‘(e) PROCEDURES APPLICABLE TO PATENT TERM

8 RESTORATION APPLICATIONS.—The Director has the au9 thority to accept an application submitted under this sec10 tion and sections 156, 156a, and 158 after the date speci11 fied in such sections in exceptional circumstances or where 

12 good cause is shown for the delay in submitting the appli13 cation, except no application may be accepted under any 

14 of these sections more than 30 days after the date speci15 fied in such section. 

16 ‘‘(f) RULES OF CONSTRUCTION REGARDING RE17 SEARCH TOOLS.—Nothing in this section or chapter 18 

18 of title 35, United States Code, shall be construed to re19 strict the right of an entity to— 

20 ‘‘(i) secure and enforce patents with 

21 regard to research tools; 

22 ‘‘(ii) enter into exclusive, revocable, 

23 and nontransferable licenses of such re24 search tools; or 
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1 ‘‘(iii) impose limits on royalty- or 

2 product-reach-through or downstream 

3 rights or agreements on future counter4 measures or products, or option rights with 

5 respect to a research tool.’’. 

6 (d) DISCRETIONARY WAIVER OF MARCH-IN RIGHTS

7 AND EXCLUSIVE LICENSING.— 

8 (1) IN GENERAL.—The owner of a patent over 

9 which the Government has rights under chapter 18 

10 of title 35, United States Code, may request that a 

11 Federal agency under whose funding a subject in12 vention was made may waive rights the Government 

13 has under sections 200, 203, and 209 of title 35, 

14 United States Code. 

15 (2) REQUESTS.—If a request under paragraph 

16 (1) is made within 90 days after the date that the 

17 entity obtained title to the patent, the Federal agen18 cy shall grant the request. 

19 (c) FEDERALLY OWNED INVENTIONS.—Section 

20 209 of title 35, United States Code, (as amended by 

21 section 301) is amended— 

22 (A) by redesignating subsections (f) and 

23 (g) as subsections (g) and (h), respectively; and 

24 (B) by inserting after subsection (e) the 

25 following: 
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1 ‘‘(f) TERMS AND CONDITIONS OF EXCLUSIVE LI2 CENSE.—Each exclusive license granted shall include a 

3 provision that, at the discretion of the licensee, the li4 censee may act as the agent for the licensor with respect 

5 to any patent for the licensed invention for purposes of 

6 extending a patent under section 156a or 158.’’. 

7 (d) TECHNICAL AND CONFORMING AMENDMENT.— 

8 The table of sections for chapter 14 of title 35, United 

9 States Code, is amended by adding after the item relating 

10 to section 158 the following: 

‘‘159. Patent term restoration for unexploited patents on Government 

sponsored inventions.’’. 

11 SEC. 1624. ENCOURAGING THE PATENTING OF RESEARCH 

12 TOOLS. 

13 Section 200 of title 35, United States Code, is 

14 amended by striking ‘‘enterprise without unduly encum15 bering future research and discovery’’ and inserting ‘‘en16 terprise’’. 

17 SEC. 1625. EFFECTIVE DATE. 

18 This title takes effect on October 1, 2005, or upon 

19 the date of enactment of this title, whichever occurs later. 

20 Subtitle C—Partnership Challenge 

21 Grants 

22 SEC. 1631. PARTNERSHIP CHALLENGE GRANTS. 

23 Part B of title III of the Public Health Service Act 

24 (42 U.S.C. 243 et seq.) (as amended by sections 202, 
243 

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1 1901, 2101, 2102, and 1401) is amended by inserting 

2 after section 319F–7 (as added by section 1401) the fol3 lowing: 

4 ‘‘SEC. 319F–8. NATIONAL INSTITUTES OF HEALTH COUN5 TERMEASURES PARTNERSHIP CHALLENGE 

6 GRANTS. 

7 ‘‘(a) GRANTS AUTHORIZED.—The Director of the 

8 National Institutes of Health (in this section referred to 

9 as the ‘Director’), in consultation with the Director of the 

10 Centers for Disease Control and Prevention, is authorized 

11 to award, in consultation with the Foundation for the Na12 tional Institutes of Health, partnership challenge grants 

13 to promote joint ventures between the National Institutes 

14 of Health, the Foundation for the National Institutes of 

15 Health, its grantees, qualified clinical countermeasures de16 livery centers, and for-profit biotechnology, pharma17 ceutical, and medical device industries for the development 

18 of countermeasures and research tools. 

19 ‘‘(b) REGULATIONS.—The Director shall issue regu20 lations within 90 days of the date of enactment of this 

21 section to implement the awarding of grants under sub22 section (a). 

23 ‘‘(c) RULE OF CONSTRUCTION.—Nothing in this sec24 tion shall be construed to preclude an entity that receives 

25 a partnership challenge grant under this section from also 
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1 being certified as being eligible for the tax, procurement, 

2 intellectual property, and liability incentives provided for 

3 under the amendments made by subtitle A of title III of 

4 the Project BioShield II Act of 2005. 

5 ‘‘(d) SAFETY TRAINING PROGRAM.—The Director of 

6 NIH, in consultation with the Director of the Centers for 

7 Disease Control and Prevention, shall establish a safety 

8 training program for researchers working in biosafety level 

9 3 or 4 facilities. 

10 ‘‘(e) TRANSFER OF FUNDS.—The Director is author11 ized to transfer funds to the Foundation for the National 

12 Institutes of Health to be used for partnership grants and 

13 other costs associated with administering this section. 

14 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

15 are authorized to be appropriated such sums as may be 

16 necessary for each of fiscal years 2004, 2005, 2006, 2007, 

17 and 2008 for the purpose of carrying out this section.’’ 

18 TITLE XVII—DEVELOPMENT OF 

19 COUNTERMEASURE RE20 SEARCH AT THE DEPART21 MENT OF DEFENSE 

22 SEC. 1701. DEVELOPMENT OF COUNTERMEASURE RE23 SEARCH AT THE DEPARTMENT OF DEFENSE. 

24 There are authorized to be appropriated to the De25 partment of Health and Human Services, including funds 
245 

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1 appropriated under the Project BioShield Act of 2004 and 

2 this Act, such sums as may be necessary to secure and 

3 facilitate the development of countermeasures, as defined 

4 in section 319F–3 of the Public Health Service Act (as 

5 added by section 202), and infectious disease research at 

6 the Department of Defense. 

7 SEC. 1702. REQUEST BY THE DEPARTMENT OF DEFENSE. 

8 (a) IN GENERAL.—Upon request by the Secretary of 

9 Defense, the Secretary of Health and Human Services 

10 may establish interagency agreements, under terms ac11 ceptable to the Secretary of Health and Human Services, 

12 in which the Department of Defense may order counter13 measures under procurement contracts or procurement 

14 pools established by the Secretary of Health and Human 

15 Services. 

16 (b) PROCESSING OF ORDERS.—The ordering of a 

17 countermeasure under an agreement under subsection (a) 

18 (including transfers of appropriated funds between the 

19 Department of Defense and the Department of Health 

20 and Human Services to pay for such orders) may be con21 ducted pursuant to section 1535 of title 31, United States 

22 Code, if such order is processed under the terms estab23 lished— 
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1 (1) by the Secretary in the interagency agree2 ment described under subsection (a) for all other or3 ders; and 

4 (2) in the Project BioShield Act of 2004 and 

5 the Project BioShield II Act of 2005 (and the 

6 amendments made by such Acts) with respect to the 

7 procurement of countermeasures under section 

8 319F–2 and section 319F–1 of the Public Health 

9 Service Act. 

10 SEC. 1703. EXPANDED PUBLIC-PRIVATE PARTNERSHIP 

11 AGREEMENTS FOR RESEARCH AND DEVELOP12 MENT. 

13 (a) COOPERATIVE RESEARCH AND DEVELOPMENT

14 AGREEMENTS.— 

15 (1) AUTHORITY.—In order to develop counter16 measures and research tools, the Secretary of De17 fense may— 

18 (A) authorize the directors or commanders 

19 of laboratories and technical activities to enter 

20 into agreements under section 3710a of title 15, 

21 United States Code; and 

22 (B) subject to requirements analogous to 

23 those governing the licensing of federally owned 

24 inventions under section 209 of title 35, United 

25 States Code, grant nonexclusive, exclusive, or 
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1 partially exclusive licenses, royalty-free or for 

2 royalties or other consideration, for computer 

3 software developed at a laboratory or technical 

4 activity that would, if the information involved 

5 were obtained from a non-Federal source, con6 stitute a trade secret or commercial or financial 

7 information that is privileged or confidential 

8 under the meaning of section 552(b)(4) of title 

9 5, United States Code. 

10 (2) PROTECTION OF SOFTWARE.—The Sec11 retary of Defense shall provide appropriate pre12 cautions against the unlicensed dissemination of any 

13 software licensed under paragraph (1)(B), including 

14 exemption from subchapter II of chapter 5 of title 

15 5, United States Code (commonly known as the Ad16 ministrative Procedure Act), for a period of up to 5 

17 years after the development of the software by the 

18 laboratory or technical activity. 

19 (b) ROYALTIES.— 

20 (1) IN GENERAL.—Except as provided in para21 graph (2), any royalties or other payments received 

22 by the Department of Defense from licensing com23 puter software under subsection (a)(1)(B) shall be 

24 disposed of as follows: 
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1 (A) The Department may provide appro2 priate incentives, from royalties or other pay3 ments, to laboratory and technical activity em4 ployees who are not developers of such com5 puter software but who substantially increased 

6 the technical value of the software. 

7 (B) The Department shall retain the royal8 ties and other payments received until the De9 partment or the laboratory or technical activity 

10 involved makes payments to employees of a lab11 oratory or technical activity under subpara12 graph (A). 

13 (C) The balance of the royalties or other 

14 payments shall be transferred by the Depart15 ment of Defense to the accounts of any of its 

16 laboratories and technical activities, with the 

17 majority share of the royalties or other pay18 ments from any invention going to the account 

19 of the laboratory or technical activity respon20 sible for the invention. The royalties or other 

21 payments so transferred may be used or obli22 gated by a laboratory or technical activity dur23 ing the fiscal year in which they are received or 

24 during the 2 succeeding fiscal years— 
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1 (i) to reward scientific, engineering, 

2 and technical employees of the laboratory 

3 or technical activity, including developers 

4 of sensitive or classified technology, re5 gardless of whether the technology has 

6 commercial applications; 

7 (ii) to further scientific exchange 

8 among the laboratories and technical ac9 tivities of the Department; 

10 (iii) for education and training of em11 ployees consistent with the research and 

12 development missions and objectives of the 

13 Department or the laboratory or technical 

14 activity, and for other activities that in15 crease the potential for transfer of the 

16 technology of the laboratories and technical 

17 activities; 

18 (iv) for payment of expenses inci19 dental to the administration and licensing 

20 of computer software or other intellectual 

21 property made at that laboratory or tech22 nical activity, including the fees or other 

23 costs for the services of other agencies, 

24 persons, or organizations for intellectual 
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1 property management and licensing serv2 ices; or 

3 (v) for scientific research and develop4 ment consistent with the research and de5 velopment missions and objectives of the 

6 laboratory or technical activity. 

7 (D) All royalties or other payments re8 tained by the Department or laboratory or tech9 nical activity after payments have been made 

10 pursuant to subparagraphs (A), (B), and (C) 

11 that are unobligated and unexpended at the end 

12 of the second fiscal year succeeding the fiscal 

13 year in which the royalties and other payments 

14 were received shall be paid into the Treasury of 

15 the United States. 

16 (2) EXCESS PAYMENTS.—If, after payments to 

17 employee-developers under paragraph (1), the royal18 ties or other payments received by the Department 

19 of Defense in any fiscal year exceed 5 percent of the 

20 budget of the Department for that year, 75 percent 

21 of such excess shall be paid to the Treasury of the 

22 United States and the remaining 25 percent may be 

23 used or obligated as described in paragraph (1)(C). 

24 Any funds not so used or obligated shall be paid into 

25 the Treasury of the United States. 
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1 (3) TREATMENT OF PAYMENTS.—Any payment 

2 made to an employee under this subsection shall be 

3 in addition to the regular pay of the employee and 

4 to any other awards made to the employee, and shall 

5 not affect the entitlement of the employee to any 

6 regular pay, annuity, or award to which such em7 ployee is otherwise entitled or for which such em8 ployee is otherwise eligible or limit the amount 

9 thereof. Any such payment made to an employee-de10 veloper shall continue after the developer leaves the 

11 laboratory or technical activity or the Department. 

12 Payments made under this section shall not exceed 

13 $150,000 per year to any one person, unless the 

14 President approves a larger award (with the amount 

15 in excess of $150,000 being treated as a Presidential 

16 award under section 4504 of title 5, United States 

17 Code). 

18 (c) REGULATIONS.—The Secretary of Defense shall 

19 promulgate regulations implementing this section. 

20 (d) INFORMATION IN REPORT.—The report required 

21 under section 2515(d) of title 10, United States Code, 

22 shall include information regarding the implementation 

23 and effectiveness of this section. 

24 (e) LABORATORY AND TECHNICAL ACTIVITY DE25 FINED.—As used in this section, the terms ‘‘laboratory’’ 
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1 and ‘‘technical activity’’ mean any facility or group of fa2 cilities that is owned, leased, operated, or otherwise used 

3 by the Department of Defense to perform research, devel4 opment, engineering, testing, or evaluation. The term in5 cludes Department of Defense universities, depots, logis6 tics centers, test centers, shipyards, arsenals, or similar 

7 organizations that perform these activities in any capacity 

8 consistent with their missions, regardless of whether such 

9 activities are a primary or substantial element of such mis10 sions. This definition also shall be used by Department 

11 of Defense entities when entering into cooperative re12 search and development agreements under section 3710a 

13 of title 15, United States Code. 

14 (f) EFFECTIVE DATE AND EXPIRATION.—The au15 thority provided for in this section is for a pilot program 

16 to test the effectiveness of this authority and shall expire 

17 on December 31, 2009. 

18 TITLE XVIII—MILLENNIUM 

19 MEDICINE DISCOVERY AWARD 

20 SEC. 1801. MILLENNIUM MEDICINE DISCOVERY AWARD. 

21 Part P of title III of the Public Health Service Act 

22 (42 U.S.C. 280 et seq.) is amended by adding at the end 

23 the following: 
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1 ‘‘SEC. 3990. MILLENNIUM MEDICINE DISCOVERY AWARD. 

2 ‘‘(a) ESTABLISHMENT OF AWARD.—There is estab3 lished an award to be known as the Millennium Medicine 

4 Discovery Award (referred to in the section as the 

5 ‘Award’). 

6 ‘‘(b) PURPOSE OF AWARD.—The Secretary shall 

7 present the Award to an individual, institution of higher 

8 learning (as defined in section 101(a) of the Higher Edu9 cation Act of 1965 (20 U.S.C. 1001(a)), or commercial 

10 entity that— 

11 ‘‘(1) discovers a vaccine or therapeutic that 

12 cures or prevents AIDS; 

13 ‘‘(2) discovers a vaccine or therapeutics that 

14 prevents infection from malaria; 

15 ‘‘(3) discovers a new class of anti-microbials; or 

16 ‘‘(4) attains another achievement in infectious 

17 disease research as determined by the Secretary. 

18 ‘‘(c) REGULATIONS.— 

19 ‘‘(1) IN GENERAL.—The Secretary shall by reg20 ulation establish the medical discoveries for which 

21 the Award may be conferred, the amount of the 

22 award, and the application process for the Award. 

23 ‘‘(2) LIMITATION.—The amount of an Award 

24 under this section, which shall be in the form of 

25 cash, shall not exceed $100,000,000 per discovery. 
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1 ‘‘(d) EXAMPLES OF DISCOVERIES.—Discoveries that 

2 may qualify for an Award under this section may include 

3 1 of the following: 

4 ‘‘(1) An oral vaccine delivery system, or needle5 free system, that provides primary immunization 

6 against bioterrorism agents, infectious disease, or 

7 significant diseases of the developing world. 

8 ‘‘(2) A new adjuvant for vectored or recom9 binant DNA vaccines that induce and sustain both 

10 cellular and humeral responses in humans that is di11 rected at bioterrorism agents, infectious diseases, or 

12 significant diseases of the developing world. 

13 ‘‘(3) A vaccine that provides lifelong protection 

14 against HIV–1 infection, or a vaccine that lessens 

15 the viral load in those immunized people who become 

16 infected or that delays the clinical progression of dis17 ease and decreases transmission of the virus through 

18 the immunized population. 

19 ‘‘(4) A microbicide that prevents or significantly 

20 reduces HIV transmission and other infections. In 

21 this paragraph, the term ‘microbicide’ means a 

22 range of products, including those products in gel, 

23 cream, film, ring, or suppository form that, when ap24 plied topically, prevent HIV transmission and other 

25 sexually transmitted diseases. 
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1 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated such sums as may be 

3 necessary to carry out this section. The Secretary shall 

secure 1 4 ⁄2 of the funding for the Awards under this section 

5 from other entities, including nonprofit institutions.’’. 

6 TITLE XIX—FOOD AND DRUG 

7 ADMINISTRATION 

8 SEC. 1901. OTHER INCENTIVES. 

9 Part B of title III of the Public Health Service Act 

10 (42 U.S.C. 243 et seq.) is amended by inserting after sec11 tion 319F–3 (as added by section 202) the following: 

12 ‘‘SEC. 319F–4. ACCELERATED APPROVAL OF COUNTER13 MEASURES. 

14 ‘‘(a) IN GENERAL.—The Secretary may designate a 

15 countermeasure as a fast-track product pursuant to sec16 tion 506 of the Federal Food, Drug, and Cosmetic Act 

17 (21 U.S.C. 356) or as a device granted priority review pur18 suant to section 515(d)(5) of such Act (21 U.S.C. 

19 366e(d)(5)). Such a designation may be made prior to the 

20 submission of— 

21 ‘‘(1) a request for designation by the sponsor or 

22 applicant; or 

23 ‘‘(2) an application for the investigation of the 

24 drug under section 505(i) (21 U.S.C. 355(i)) of such 

25 Act or section 351(a)(3). 
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1 Nothing in this subsection shall be construed to pro2 hibit a sponsor or applicant from declining such a designa3 tion. 

4 ‘‘(b) USE OF ANIMAL TRIALS.—A drug for which ap5 proval is sought under section 505(d) of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 355(d)) or section 351 

7 on the basis of evidence of effectiveness that is derived 

8 from animal studies may be designated as a fast-track 

9 product for purposes of this section. 

10 ‘‘(c) PRIORITY REVIEW.— 

11 ‘‘(1) IN GENERAL.—A countermeasure that is a 

12 drug or biological product shall be subject to the 

13 performance goals established by the Commissioner 

14 of Food and Drugs for priority drugs or biological 

15 products. 

16 ‘‘(2) DEFINITION.—In this subsection, the term 

17 ‘priority drugs or biological products’ means a drug 

18 or biological product that is the subject of a drug 

19 application referred to in section 101(4) of the Food 

20 and Drug Administration Modernization Act of 

21 1997.’’. 

22 SEC. 1902. SYSTEMS BIOLOGY. 

23 (a) FINDINGS.—Congress makes the following find24 ings: 
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1 (1) Systems biology, the application of com2 putational tools to understand the dynamic behavior 

3 of biological networks as integrated systems rather 

4 than isolated parts, is an emerging field of research. 

5 (2) Open-source systems biology can play a role 

6 in accelerating understanding of complex biological 

7 systems, increasing confidence in the analysis and 

8 prioritization of drug targets, enabling predictive 

9 toxicology, and other emerging capabilities. 

10 (3) Such capabilities can lead to shorter drug 

11 development times, speeding the delivery of needed 

12 medication to address public health concerns, and 

13 may help decrease or manage the high risks associ14 ated with the entire drug development system, re15 sulting in a reduction of the mounting costs of drug 

16 development and an increase in the number of new 

17 entities brought to market to improve public health. 

18 (b) IMPLEMENTATION OF BIOLOGY RESEARCH PRO19 GRAMS.—The Secretary of Health and Human Services 

20 shall promulgate regulations implementing— 

21 (1) systems biology research programs, includ22 ing systems biology tool development, model develop23 ment, and integration of such research into experi24 mental frameworks validating and exploiting re25 search results; 
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1 (2) research efforts, including systems biology 

2 approaches, directed to address the detection of bio3 threat agents through blood samples; and 

4 (3) such programs described in the Food and 

5 Drug Report of March 2004 entitled ‘‘Critical Path 

6 Initiative’’ that enable the development of tools and 

7 methods for the rapid approval of safe medications 

8 for the treatment of anticipated biohazards. 

9 SEC. 1903. BIOTERROR AND INFECTIOUS DISEASE PROVI10 SIONS. 

11 (a) BIOTERROR AND INFECTIOUS DISEASE PROVI12 SIONS.—Chapter V of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 351 et seq.) is amended by adding 

14 at the end the following: 

15 ‘‘Subchapter F—Bioterror and Infectious 

16 Disease Products 

17 ‘‘SEC. 571. DEFINITIONS. 

18 ‘‘In this subchapter: 

19 ‘‘(1) BIOLOGICAL AGENT.—The term ‘biological 

20 agent’, ‘biological toxin’, or any variation of any 

21 such term, means any microorganism, virus, infec22 tious substance, or biological product, that may be 

23 used in a manner that is intended to cause wide24 spread death or serious bodily injury, including bio25 logical agents and toxins described in paragraphs (1) 
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1 and (2) of section 178 of title 18, United States 

2 Code. 

3 ‘‘(2) BIOTERROR OR INFECTIOUS DISEASE

4 PRODUCT.—The term ‘bioterror or infectious disease 

5 product’ means a countermeasure against a biologi6 cal agent. 

7 ‘‘(3) COUNTERMEASURE.—The term ‘counter8 measure’ means— 

9 ‘‘(A) a vaccine and related delivery system, 

10 anti-infective, microbicide, diagnostic tech11 nology, drug, biological product, or other tech12 nology that can be used to diagnose, treat, or 

13 prevent infection with or bodily harm from, or 

14 the spread of, a biological or chemical agent or 

15 toxin on the list described in section 319F–3(f) 

16 of the Public Health Service Act, and that is 

17 subject to applicable provisions of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 301 

19 et seq.), the Public Health Service Act (42 

20 U.S.C. 201 et seq.), or the Virus-Serum-Toxin 

21 Act (21 U.S.C. 151 et seq.); 

22 ‘‘(B) a therapy, diagnostic, or piece of 

23 equipment that may be used to detect, treat, or 

24 prevent bodily harm that may be caused by the 
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1 use of nuclear or radiological material as a ter2 ror weapon; 

3 ‘‘(C) a qualified countermeasure, as de4 fined in section 319F–1 of the Public Health 

5 Service Act (42 U.S.C. 247d–6a); and 

6 ‘‘(D) a security countermeasure, as defined 

7 in section 319F–2 (42 U.S.C. 246d–6b). 

8 ‘‘(4) INFECTIOUS DISEASE.— 

9 ‘‘(A) IN GENERAL.—The term ‘infectious 

10 disease’ means a disease in humans caused 

11 by— 

12 ‘‘(i) a microbe (including a bacteria, 

13 virus, fungus, or parasite) that is acquired 

14 by a person that reproduces in that person; 

15 ‘‘(ii) microbial products (such as botu16 linum toxin); or 

17 ‘‘(iii) a prion. 

18 ‘‘(B) INCLUSION.— 

19 ‘‘(i) a disease in humans caused by a 

20 microorganism, whether or not— 

21 ‘‘(I) such microorganism is ac22 quired by an individual through 

23 human-to-human contact; or 

24 ‘‘(II) if the individual is initially 

25 symptomatic of the disease; and 
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1 ‘‘(ii) zoonotic diseases that may find 

2 hosts in animal and human populations. 

3 ‘‘SEC. 572. DEPUTY COMMISSIONER FOR BIOLOGICAL, 

4 CHEMICAL, NUCLEAR, RADIOLOGICAL, AND 

5 INFECTIOUS DISEASE PRODUCTS. 

6 ‘‘(a) ESTABLISHMENT OF OFFICE.—There is estab7 lished within the Office of Counterterrorism of the Office 

8 of the Commissioner of the Food and Drug Administra9 tion an Office of the Deputy Commissioner for Biological, 

10 Chemical, Nuclear, Radiological, and Infectious Disease 

11 Products (referred to in this section as the ‘Deputy Com12 missioner’). 

13 ‘‘(b) DUTIES.—The Deputy Commissioner shall— 

14 ‘‘(1) oversee, plan, and direct resources and 

15 personnel of the Center for Biologics Evaluation and 

16 Research, the Center for Drug Evaluation and Re17 search, and other relevant offices within the Food 

18 and Drug Administration, toward the evaluation of 

19 products for the prevention, surveillance, diagnosis, 

20 and treatment of biological, chemical, nuclear, radio21 logical, and emerging infectious disease threats; 

22 ‘‘(2) review not less than annually, the progress 

23 of such offices with respect to the functions de24 scribed under paragraph (1); and 
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1 ‘‘(3) consult with the Commissioner of Food 

2 and Drugs with respect to carrying out the duties 

3 described under paragraph (1). 

4 ‘‘(c) AUTHORITY.—The Deputy Commissioner 

5 shall have the authority to address staffing needs 

6 and compensation for shortfalls resulting from any 

7 waiver of user fees under section 574. 

8 ‘‘SEC. 573. ACCELERATED APPROVAL FOR CERTAIN PROD9 UCTS. 

10 ‘‘The Secretary shall, at the request of the sponsor 

11 of a new bioterror or infectious disease product, deem such 

12 countermeasure a fast track product under section 506 

13 if— 

14 ‘‘(1) there is no other countermeasure product 

15 approved by the Food and Drug Administration suf16 ficient to respond to the bioterror or pathogen threat 

17 addressed by such new product; and 

18 ‘‘(2) the bioterror or pathogen threat addressed 

19 by such new product is eminent, as determined by 

20 the Secretary, in consultation with the Secretary of 

21 Homeland Security and the Director of the Centers 

22 for Disease Control and Prevention. 

23 ‘‘SEC. 574. WAIVER OF USER FEES. 

24 ‘‘(a) IN GENERAL.—The Secretary shall waive the as25 sessment of a user fee under chapter VII to the application 
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1 and approval of a bioterror or infectious disease product. 

2 Such waivers shall not result in a reduction of funds avail3 able to the Secretary for conducting review of such appli4 cations and approvals. 

5 ‘‘(b) LIMITATION.—The Secretary shall not waive an 

6 assessment of a user fee under subsection (a) for an appli7 cant more than once.’’. 

8 SEC. 1904. APPROVALS OF CERTAIN DRUGS BASED ON ANI9 MAL TRIALS. 

10 (a) FEDERAL FOOD, DRUG, AND COSMETIC ACT.— 

11 Section 505(d) of the Federal Food, Drug, and Cosmetic 

12 Act (21 U.S.C. 355(d)) is amended by adding at the end 

13 the following: ‘‘In the case of drugs and diagnostic devices 

14 for use against infectious disease or lethal or permanently 

15 disabling toxic biological, chemical, radiological, nuclear, 

16 or other substances, when adequate and well-controlled 

17 studies of effectiveness in humans cannot ethically be con18 ducted because the studies would involve administering a 

19 potentially lethal or permanently disabling toxic substance 

20 or organism to healthy human volunteers, and when ade21 quate field trials assessing use of the drug or diagnostic 

22 device (in situations such as after accidental or hostile ex23 posure to the substance) have not been feasible or where 

24 adequate volumes of human samples for diagnosis from 

25 previous exposures is not available, the Secretary may 
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1 grant approval based on evidence of effectiveness derived 

2 from appropriate studies in animals. The Secretary may 

3 promulgate regulations establishing standards, criteria, 

4 and procedures for use of the authority contained in the 

5 preceding sentence.’’. 

6 (b) PUBLIC HEALTH SERVICE ACT.—Section 351 of 

7 the Public Health Service Act (42 U.S.C. 262) is amended 

8 by adding at the end the following: 

9 ‘‘(k) APPROVAL OF CERTAIN PRODUCTS AND DIAG10 NOSTIC DEVICES BASED ON ANIMAL TRIALS.—In the 

11 case of biological products and diagnostic devices for use 

12 against infectious disease, or lethal or permanently dis13 abling toxic biological, chemical, radiological, nuclear, or 

14 other substances, when definitive human effectiveness 

15 studies in humans cannot ethically be conducted because 

16 the studies would involve administering a potentially lethal 

17 or permanently disabling toxic substance or organism to 

18 healthy human volunteers, and when adequate field trials 

19 assessing use of the drug (in situations such as after acci20 dental or hostile exposure to the substance) have not been 

21 feasible, the Secretary may grant approval based on evi22 dence of effectiveness derived from appropriate studies in 

23 animals. The Secretary may promulgate regulations estab24 lishing standards, criteria, and procedures for use of the 

25 authority provided under this subsection.’’. 
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1 (c) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated such sums as may be 

3 necessary to carry out this section (and the amendments 

4 made by this section). 

5 SEC. 1905. CLINICAL TRIAL GUIDELINES FOR ANTI6 INFECTIVES. 

7 Chapter V of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

9 section 510 the following: 

10 ‘‘SEC. 511. CLINICAL TRIAL GUIDELINES FOR ANTI11 INFECTIVES. 

12 ‘‘(a) IN GENERAL.—Not later than 1 year after the 

13 date of enactment of the Project BioShield II Act of 2005, 

14 the Secretary, acting through the Commissioner of Food 

15 and Drugs, shall issue guidelines for the conduct of clin16 ical trials with respect to anti-microbials, including anti17 microbials to treat resistant pathogens, bacterial menin18 gitis, acute bacterial sinusitis, acute bacterial otitis media, 

19 and acute exacerbation of chronic bronchitis. Such guide20 lines shall indicate the appropriate animal models of infec21 tion, in vitro techniques, and valid microbiologic surrogate 

22 markers. 

23 ‘‘(b) REVIEW.—Not later than 5 years after the date 

24 of enactment of the Project BioShield II Act of 2005, the 

25 Secretary, acting through the Commissioner of Food and 
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1 Drugs, shall review and update the guidelines described 

2 under subsection (a) to reflect developments in scientific 

3 and medical information and technology.’’. 

4 SEC. 1906. AUTHORIZATION OF APPROPRIATIONS FOR FDA 

5 PURCHASE OF MICROBIOLOGICAL DATA. 

6 (a) IN GENERAL.—There are authorized to be appro7 priated $3,000,000 for fiscal year 2007 for the purpose 

8 of strengthening the ability of the Food and Drug Admin9 istration to evaluate antibiotics for the treatment of tar10 geted pathogens. 

11 (b) SOLE PURPOSE.—Such funds shall be used solely 

12 for the purpose of contracting with entities that the Sec13 retary of Health and Human Services determines capable 

14 of providing national, real-time microbiological data rel15 evant to antibiotic sensitivity of all clinically relevant 

16 strains of bacterial pathogens. 

17 SEC. 1907. AUTHORIZATION OF APPROPRIATIONS TO IM18 PLEMENT PUBLIC HEALTH SERVICE ACTION 

19 PLAN TO COMBAT ANTIMICROBIAL RESIST20 ANCE. 

21 To implement the Public Health Service action plan 

22 to combat antimicrobial resistance (Public Health Action 

23 Plan to Combat Antimicrobial Resistance, Part 1: Domes24 tic Issues (January 18, 2001)) as developed by the Inter25 agency Antimicrobial Resistance Task Force authorized 
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1 under section 319E of the Public Health Service Act (42 

2 U.S.C. 247d–5), there are authorized to be appropriated 

3 $25,000,000 for fiscal year 2007. 

4 TITLE XX—ANIMAL MODELS 

5 SEC. 2001. ANIMAL MODELS FOR CERTAIN DISEASES. 

6 (a) FINDING.—Congress finds that the development 

7 of well-characterized animal models for identified threat 

8 agents is crucial for testing the efficacy of medical coun9 termeasures, and that data is crucial for licensure of prod10 ucts to protect the Nation, particularly those animals ge11 netically designed and bred to mimic the disease or toxic 

12 response of humans to a particular biological insult. 

13 (b) ESTABLISHMENT OF WORKING GROUP; GRANTS

14 TO STUDY ANIMAL RESPONSES.—Subpart 6 of part C of 

15 title IV of the Public Health Service Act (42 U.S.C. 285f 

16 et seq.) is amended by adding at the end the following: 

17 ‘‘SEC. 447C. ESTABLISHMENT OF WORKING GROUP. 

18 ‘‘(a) IN GENERAL.—The Director of the Institute, in 

19 consultation with the Assistant Secretary for Medical 

20 Readiness and Response of the Department of Homeland 

21 Security and the Director of the Centers for Disease Con22 trol and Prevention, shall establish a working group to 

23 carry out the duties described in subsection (b) (referred 

24 to in this section as the ‘Working Group’). 
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1 ‘‘(b) DUTIES.—The Working Group shall determine 

2 the most pressing scientific gaps in understanding that 

3 must be addressed to create accurate animal models used 

4 to determine disease processes for agents that threaten 

5 humans. 

6 ‘‘(c) MEMBERSHIP.—The Working Group shall in7 clude not less than one Director of a center in the National 

8 Private Research Program. 

9 ‘‘SEC. 447D. GRANTS TO STUDY ANIMAL RESPONSES. 

10 ‘‘(a) IN GENERAL.—The Secretary, in consultation 

11 with the Commissioner of Food and Drugs and the Sec12 retary of Homeland Security, shall— 

13 ‘‘(1) establish and award grants under this sec14 tion to eligible entities to study the physiological re15 sponses of certain animal species to bioterrorism 

16 agents and other infectious agents; and 

17 ‘‘(2) coordinate efforts to identify and develop 

18 well-characterized animal models, including cor19 relates of protection, when feasible, for categories of 

20 infectious diseases, and classes of toxins considered 

21 the most likely threats to human populations, as 

22 identified as bioterror agents by the Office of Emer23 gency Preparedness and Response of the Centers for 

24 Disease Control and Prevention. 
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1 ‘‘(b) ELIGIBILITY; APPLICATION.—To be eligible to 

2 receive a grant under this section, an entity shall— 

3 ‘‘(1) provide assurances to the Secretary that 

4 the entity has a biosafety level 3 or 4 facility that 

5 is approved by the Centers for Disease Control and 

6 Prevention or has a contractual relationship with 

7 such a facility; and 

8 ‘‘(2) with respect to an animal biosafety lab, 

9 provide assurances that such lab is in compliance 

10 with the Guide for the Care and Use of Laboratory 

11 Animals and the Animal Welfare Act (7 U.S.C. 2131 

12 note); and 

13 ‘‘(3) submit to the Secretary an application at 

14 such time, in such manner, and containing such in15 formation as the Secretary may require. 

16 ‘‘(c) BENEFITS UNDER PROJECT BIOSHIELD.— 

17 ‘‘(1) IN GENERAL.—If the Secretary determines 

18 that an entity receiving a grant under this section 

19 has successfully and thoroughly created an animal 

20 model for the purpose of testing and regulating 

21 novel countermeasures, such animal model shall be 

22 considered a research tool for purposes of receiving 

23 the benefits under the amendments made by the 

24 Project BioShield II Act of 2005. 
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1 ‘‘(2) CLARIFICATION.—An animal model may 

2 be developed, and subsequently recommended by the 

3 Food and Drug Administration, separately from a 

4 countermeasure application so that such animal 

5 model is regarded as a research tool for the counter6 measure and such Administration may require such 

7 recommended animal model in clinical trials to fulfill 

8 regulatory requirements. 

9 ‘‘(d) DEFINITIONS.— 

10 ‘‘(1) BIOSAFETY LEVEL 3 FACILITY.—The term 

11 ‘biosafety level 3 facility’ means a facility described 

12 in section 627.15 of title 32, Code of Federal Regu13 lations (or any successor regulation). 

14 ‘‘(2) BIOSAFETY LEVEL 4 FACILITY.—The term 

15 ‘biosafety level 4 facility’ means a facility described 

16 in section 627.16 of title 32, Code of Federal Regu17 lations (or any successor regulation). 

18 ‘‘(3) RESEARCH TOOL.—The term ‘research 

19 tool’ includes the full range of tools that scientists 

20 may use in the laboratory, including animal disease 

21 models, cell lines, cell line cultures for the produc22 tion of biologics, monoclonal and polyclonal anti23 bodies, reagents, drug delivery technologies, vaccine 

24 adjuvants, laboratory animals, large animals includ25 ing nonhuman primates and large animals used for 
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1 drug production, growth factors, combinatorial 

2 chemistry and DNA libraries, antigen libraries, 

3 clones and cloning tools (such as PCR or Real Time 

4 PCR), methods, laboratory equipment and machines, 

5 databases, and other technologies that enable the 

6 rapid and effective development of countermeasures, 

7 including diagnostics, vaccines, and drugs. 

8 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

9 are authorized to be appropriated such sums as may be 

10 necessary for the development of animals models described 

11 under subsection (a)(2).’’. 

12 SEC. 2002. ANIMAL MODELS FIVE-YEAR INITIATIVE. 

13 (a) FINDINGS.—Congress finds the following: 

14 (1) The United States Government has made 

15 an unprecedented commitment to expanding and ad16 vancing the biomedical research program at the Na17 tional Institutes of Health, and the success of the 

18 Government’s efforts is contingent upon the avail19 ability of quality resources that will enable and en20 hance all research endeavors ranging from the most 

21 basic and fundamental to the most highly innovative. 

22 (2) Biomedical research has relied on such 

23 quality resource, the National Primate Research 

24 Centers Program, for more than 40 years, for re-
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1 search models and expertise with non-human pri2 mates. 

3 (3) The National Primate Research Centers 

4 Program is comprised of a network of 8 National 

5 Primate Research Centers (referred to in this sec6 tion ‘‘NPRCs’’) that provide centralized housing and 

7 care for non-human primates, as well as the facilities 

8 and support necessary for research conducted with 

9 such primates. Scientists from almost every State 

10 use the resources of the NPRCs for a vast array of 

11 studies. 

12 (4) As a result of expanded investment in bio13 medical research from 2000 to 2005, the demand for 

14 the resources of the NPRCs has increased signifi15 cantly, but several important impediments have be16 come barriers to successful non-human primate re17 search, including the limited number of such pri18 mates available, the lack of infrastructure to breed 

19 and house animals for research, and the need for 

20 trained staff for handling and sophisticated care. 

21 (5) In order to remedy such problems, the Na22 tional Institutes of Health needs to support a Fed23 eral advancement initiative for the NPRCs that ad24 dresses the necessary upgrades and program capac25 ity expansions. 
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1 (b) FIVE-YEAR INITIATIVE FOR PRIMATE CEN2 TERS.— 

3 Subpart 1 of Part E of title IV of the Public Health 

4 Service Act (42 U.S.C. 287 et seq.) is amended by— 

5 (1) redesignating the section 481C as added by 

6 Public Law 106–505 as section 481D; and 

7 (2) by adding at the end the following: 

8 ‘‘SEC. 481E. FIVE-YEAR INITIATIVE FOR PRIMATE CENTERS. 

9 ‘‘(a) IN GENERAL.—The Secretary shall provide ad10 ditional sums to the base grants provided to the National 

11 Primate Research Centers by the National Center for Re12 search Resources in order to— 

13 ‘‘(1) increase domestic breeding capabilities; 

14 ‘‘(2) develop bridging programs to effectively 

15 utilize additional primate species; 

16 ‘‘(3) increase the quality and capacity of pri17 mate housing and breeding facilities and the avail18 ability of related state-of-the-art diagnostic and clin19 ical support equipment for primates; and 

20 ‘‘(4) increase the number of personnel trained 

21 in primate care and management at the National 

22 Primate Research Centers. 

23 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 

24 are authorized to be appropriated such sums as may be 

25 necessary to carry out this section.’’. 
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1 TITLE XXI—STRENGTHENING OF 

2 THE VACCINE INDUSTRY 

3 Subtitle A—Biologics, Adjuvants, 

4 and Cell Culture Development 

5 SEC. 2101. BIOLOGICS MANUFACTURING CAPACITY INCEN6 TIVES. 

7 Part B of title III of the Public Health Service Act 

8 (42 U.S.C. 243 et seq.) (as amended by sections 202 and 

9 1901) is amended by inserting after section 319F–4 (as 

10 added by section 1901) the following: 

11 ‘‘SEC. 319F–5. BIOLOGICS MANUFACTURING CAPACITY IN12 CENTIVES. 

13 ‘‘(a) SURVEY AND PLAN.—Not later than 90 days 

14 after the date of enactment of the Project BioShield II 

15 Act of 2005, the Secretary shall— 

16 ‘‘(1) conduct a survey of the biologics manufac17 turing and filling facilities, including those for the 

18 production of antibiotics, vaccines, monoclonal and 

19 polyclonal antibodies, recombinant proteins, and 

20 plant compounds using cell culture methods, recom21 binant technology or other techniques, as well as 

22 those for the production of antibodies and other 

23 blood products from human and animal blood, oper24 ating in the United States and determine whether 

25 additional manufacturing facilities that will be need-
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1 ed (and if so the number of such facilities) to manu2 facture and stockpile biologically active materials for 

3 bioterrorist attacks or infectious disease outbreaks; 

4 and 

5 ‘‘(2) develop a plan to ensure that sufficient 

6 biologics manufacturing and filling facilities are 

7 available in the United States, Canada, Mexico, Eu8 rope, and Japan, when they are needed, including an 

9 analysis of the feasibility of the Federal Government 

10 contracting for the construction and maintenance of 

11 such facilities or of providing tax and other incen12 tives for the construction and maintenance of such 

13 facilities by private sector entities. 

14 ‘‘(b) SUBMISSION TO CONGRESS.—The Secretary 

15 shall submit the plan developed under subsection (a)(2) 

16 to Congress together with recommendations concerning 

17 the manner in which to ensure that the needed biologics 

18 manufacturing facilities available for the production of 

19 countermeasures under this title are constructed and 

20 available, including the siting, design and certification 

21 costs, costs of training and recruitment of expert staff, 

22 and other costs associated with such facilities. 

23 ‘‘(c) INCENTIVES FOR THE CONSTRUCTION OF BIO24 LOGICS MANUFACTURING FACILITIES AVAILABLE FOR

25 THE PRODUCTION OF COUNTERMEASURES.—The Sec-
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1 retary shall issue regulations regarding the selection of an 

2 entity that agrees to operate as a biologics manufacturing 

3 facility available for the production of countermeasures 

4 under this title in accordance with the plan developed 

5 under subsection (a)(2) for the investment tax credit pro6 vided under the amendments made by title III of the 

7 Project BioShield II Act of 2005. Such regulations shall 

8 state when such an entity shall be available and the terms 

9 for the use for the production of such countermeasures. 

10 If an entity is constructed to produce such counter11 measures, such entity shall provide notice that such entity 

12 is available to produce such countermeasures.’’. 

13 SEC. 2102. BIOLOGICS MANUFACTURING EFFICIENCY IN14 CENTIVES. 

15 Part B of title III of the Public Health Service Act 

16 (42 U.S.C. 243 et seq.) (as amended by sections 202, 

17 1901, and 2101) is amended by inserting after section 

18 319F–5 (as added by section 2101) the following: 

19 ‘‘SEC. 319F–6. BIOLOGICS MANUFACTURING EFFICIENCY IN20 CENTIVES. 

21 ‘‘(a) FINDINGS.—Congress finds that— 

22 ‘‘(1) the manufacturing of biologics, which are 

23 derived from living organisms, is an art as well as 

24 a science; 
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1 ‘‘(2) the efficiency of the biologics manufac2 turing process determines the output capacity, pu3 rity, and manufacturing cost of antibiotics, vaccines, 

4 recombinant proteins, plant compounds, antibodies, 

5 and blood products; 

6 ‘‘(3) technical advances in manufacturing 

7 sciences for biologics can increase the capacity of the 

8 Federal Government to ensure that antibiotics, vac9 cines, recombinant proteins, plant compounds, anti10 bodies, and blood products are available as part of 

11 a bioterror or infectious disease plan and to reduce 

12 the cost of manufacturing and stockpiling these vac13 cines, recombinant proteins, plant compounds, anti14 bodies, and blood products; and 

15 ‘‘(4) the subjects of research relating to the 

16 manufacturing of biologics may include the develop17 ment of— 

18 ‘‘(A) additional well-characterized cell lines 

19 or host strains for antibiotics, vaccines, recom20 binant proteins, plant compounds, and 

21 monoclonal and polyclonal antibody production; 

22 ‘‘(B) new biologic and chemical standards 

23 for use in product testing, including testing of 

24 potency and purity; 
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1 ‘‘(C) improved preservatives for vaccines or 

2 other biologics to prolong shelf-life; 

3 ‘‘(D) adjuvants that enhance the immune 

4 response; 

5 ‘‘(E) tests to determine contamination with 

6 human or animal viruses or prions; 

7 ‘‘(F) improved tests of potency and purity 

8 during the manufacturing process, not just for 

9 the final product; 

10 ‘‘(G) improved characterization of biologics 

11 at the macro-molecular level; 

12 ‘‘(H) processes that enhance the yield and 

13 quality of biologics; 

14 ‘‘(I) improved methods that enhance dis15 infection and sterilization of material and facili16 ties; 

17 ‘‘(J) new methods to improve output, man18 ufacturing costs, and product quality with a 

19 particular emphasis on downstream processing 

20 (separation and purification) where particular 

21 bottlenecks occur with much lost product, com22 plexity, and very high costs; and 

23 ‘‘(K) improved methods for decontamina24 tion of production facilities to enable switching 

25 from one product to another. 
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1 ‘‘(b) SURVEY AND PLAN.—Not later than 180 days 

2 after the date of enactment of the Project BioShield II 

3 Act of 2005, the Secretary shall— 

4 ‘‘(1) conduct a survey of existing biologics man5 ufacturing sciences and determine whether technical 

6 advances in such sciences might increase the bio7 logics output capacity and purity, and lower the 

8 manufacturing cost of antibiotics, vaccines, recom9 binant proteins, plant compounds, antibodies, and 

10 blood products; and 

11 ‘‘(2) develop a plan to provide incentives to en12 hance scientific research to develop new technologies 

13 identified under the survey conducted under para14 graph (1), including a list of the possible tech15 nologies that may be developed and the possible in16 centives that may lead to their development. 

17 ‘‘(c) SUBMISSION TO CONGRESS.—The Secretary 

18 shall submit the plan developed under subsection (b)(2) 

19 to Congress together with recommendations concerning 

20 the provision of funding or incentives for the conduct of 

21 scientific research to develop new technologies relating to 

22 biologics manufacturing sciences. 

23 ‘‘(d) INCENTIVES.—The Secretary shall establish a 

24 program under which entities that agree to develop new 

25 technologies, or improve existing technologies, in accord-
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1 ance with the plan developed under subsection (b)(2) are 

2 eligible for the tax incentives provided for under the 

3 amendments made by section 312 of the Project BioShield 

4 II Act of 2005.’’. 

5 SEC. 2103. DEVELOPMENT OF VACCINE ADJUVANTS. 

6 (a) FINDINGS.—Congress finds the following: 

7 (1) New vaccines are under development and 

8 testing for the control of infectious diseases includ9 ing human immunodeficiency virus infection, an10 thrax, avian flu, and many others, and additional in11 fectious diseases can be anticipated with advanced 

12 rapid, along with advanced rapid production of vac13 cine technologies. 

14 (2) Most new vaccines are composed of syn15 thetic, recombinant, or highly purified subunit anti16 gens that are safer than those in use as of the date 

17 of enactment of this Act, but their purity can result 

18 in a weaker protective response from the vaccine re19 cipient. 

20 (3) Vaccines are administered to protect a 

21 healthy population, and any complications with vac22 cines result in swift and severe public and legal re23 sponses. 

24 (4) Adjuvants are chemicals that enhance the 

25 specific protective immune response of vaccines. 
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1 (5) As of 2005, there is one aluminum salt2 based adjuvant used in vaccines licensed in the 

3 United States. 

4 (6) Standardized methods to evaluate new vac5 cine adjuvant safety must be implemented for 

6 human vaccines that are to be formulated with novel 

7 adjuvants. 

8 (7) Vaccine adjuvants should receive highest 

9 priority by the Food and Drug Administration and 

10 the National Institute of Allergy and Infectious Dis11 eases, as the failure to develop and approve them 

12 will result in the inability to deploy effective counter13 measures against bioterrorism or naturally occurring 

14 infectious diseases, even when vaccine development 

15 is achieved. 

16 (b) VACCINE ADJUVANT PRIORITY.—The Secretary 

17 of Health and Human Services shall promulgate regula18 tions that establish— 

19 (1) priority handling procedures, which may in20 cluded expedited review and fee waivers, at the Food 

21 and Drug Administration with respect to vaccine ad22 juvants; and 

23 (2) methods for evaluating the safety of— 
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1 (A) adjuvants, separate from the methods 

2 used to evaluate the safety and effectiveness of 

3 adjuvants with vaccine agents; and 

4 (B) adjuvants used in conjunction with one 

5 or more vaccine agent. 

6 (c) INCENTIVES FOR VACCINE ADJUVANT PRO7 DUCERS.— 

8 (1) IN GENERAL.—Persons that produce adju9 vants shall be entitled to receive the incentives under 

10 title III (and the amendments made by that title). 

11 (2) DEFENSE OF CERTAIN MALPRACTICE AND

12 NEGLIGENCE SUITS.—Section 224 of the Public 

13 Health Service Act (42 U.S.C. 233) (as amended by 

14 title III of this Act) shall apply to vaccine adjuvants 

15 developed for use in bioterrorism countermeasures or 

16 to treat or prevent infectious disease in the same 

17 manner as such section applies to covered counter18 measures (as defined by such section). 

19 (d) REQUESTS FOR PROPOSALS.—The Secretary of 

20 Health and Human Services shall develop and publish in 

21 the Federal Register a request for proposals with respect 

22 to adjuvant development and production. 

23 (e) AUTHORIZATION OF APPROPRIATIONS.—There 

24 are authorized to be appropriated such sums as may be 

25 necessary carry out this section. 
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1 SEC. 2104. CELL CULTURE OR RECOMBINANT VACCINES. 

2 (a) GRANTS.—The Director of the National Insti3 tutes of Health, in consultation with the Commissioner of 

4 Food and Drugs and the Director of the Centers of Dis5 ease Control and Prevention, may award grants to eligible 

6 entities for the development of cell-culture and other vac7 cine production technologies. 

8 (b) ELIGIBILITY.—To be eligible to receive a grant 

9 under this section an entity shall— 

10 (1) be a public or private entity determined ap11 propriate by the Director of the National Institutes 

12 of Health; and 

13 (2) prepare and submit to the Director an ap14 plication at such time, in such manner, and con15 taining such information as the Director may re16 quire. 

17 (c) USE OF FUNDS.—An entity shall use amounts re18 ceived under a grant under this section to carry out activi19 ties leading to the development of cell-culture and other 

20 vaccine production technology, including the retooling of 

21 outdated plants and the construction of new manufac22 turing plants. 

23 (d) ACTIVITIES OF THE FOOD AND DRUG ADMINIS24 TRATION.—To further the goal of increasing the produc25 tion of cell culture and other vaccines, the Food and Drug 

26 Administration shall— 
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1 (1) develop updated regulations relating to the 

2 approval of cell culture and other vaccines; and 

3 (2) as part of such regulations, provide for pri4 ority to be given to the inspection and evaluation of 

5 cell culture and other vaccine manufacturing plants. 

6 (e) ACTIVITIES OF THE SECRETARY.—To further the 

7 goal of increasing the production of cell culture and other 

8 vaccines, the Secretary of Health and Human Services 

9 shall— 

10 (1) develop a strategic plan for the distribution 

11 of biologicals developed at facilities constructed 

12 under a grant under this section in the case of an 

13 infectious disease outbreak; and 

14 (2) not later than 6 months after the date of 

15 enactment of this Act, submit to the appropriate 

16 committees of Congress a report on the strategy de17 veloped under paragraph (1) and on the status and 

18 use of previous vaccine development grants. 

19 (f) AUTHORIZATION OF APPROPRIATIONS.—There is 

20 authorized to be appropriated such sums as may be nec21 essary to carry out this section. 
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1 Subtitle B—Influenza Vaccine 

2 CHAPTER 1—INFLUENZA VACCINE 

3 AWARENESS CAMPAIGN 

4 SEC. 2111. AWARENESS CAMPAIGN AND EDUCATION AND 

5 OUTREACH EFFORTS. 

6 Part P of title III of the Public Health Service Act 

7 (42 U.S.C. 280g et seq.) is amended by adding at the end 

8 the following: 

9 ‘‘SEC. 399O. AWARENESS CAMPAIGN AND EDUCATION AND 

10 OUTREACH EFFORTS. 

11 ‘‘(a) CAMPAIGN.—The Secretary, acting through the 

12 Director of the Centers for Disease Control and Preven13 tion (in this section referred to as the ‘Director’), shall 

14 conduct a public awareness campaign and education and 

15 outreach efforts each year during the time period pre16 ceding the influenza season on each of the following: 

17 ‘‘(1) The importance of receiving the influenza 

18 vaccine. 

19 ‘‘(2) Which populations the Director rec20 ommends to receive the influenza vaccine to prevent 

21 health complications associated with influenza, in22 cluding health care workers and household contacts. 

23 ‘‘(3) Professional medical education of physi24 cians, nurses, pharmacists, and other health care 
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1 providers and such providers’ associated organiza2 tions. 

3 ‘‘(4) Information that emphasizes the safety 

4 and benefit of recommended vaccines for the public 

5 good. 

6 ‘‘(b) OUTREACH TO MEDICARE RECIPIENTS.— 

7 ‘‘(1) IN GENERAL.—The Administrator of the 

8 Centers for Medicare & Medicaid Services shall, at 

9 the earliest possible time in the influenza vaccine 

10 planning and production process, reach out to pro11 viders of medicare services, including managed care 

12 providers, nursing homes, hospitals, and physician 

13 offices to urge early and full preordering of the in14 fluenza vaccine so that production levels can accom15 modate the needs for the influenza vaccine. 

16 ‘‘(2) RATES OF IMMUNIZATION AMONG MEDI17 CARE RECIPIENTS.—The Director shall work with 

18 the Administrator of the Centers for Medicare & 

19 Medicaid Services to publish the rates of influenza 

20 immunization among individuals receiving assistance 

21 under the medicare program under title XVIII of the 

22 Social Security Act (42 U.S.C. 1395 et seq.). 

23 ‘‘(c) STATE AND PUBLIC HEALTH ADULT IMMUNIZA24 TION ACTIVITIES.—The Director shall support the devel25 opment of State adult immunization programs that place 
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1 emphasis on improving influenza vaccine delivery to high2 risk populations and the general population, including the 

3 exploration of improving access to the influenza vaccine. 

4 ‘‘(d) EFFICACY OF VACCINE.—The Director shall 

5 work with appropriate agencies in conducting a study to 

6 assess the efficacy of the influenza vaccine. 

7 ‘‘(e) EXISTING MODES OF COMMUNICATION.—In car8 rying out the public awareness campaign and education 

9 and outreach efforts under subsections (a) and (b), the 

10 Director may use existing websites or structures for com11 munication. 

12 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

13 are authorized to be appropriated to carry out this section 

14 $10,000,000 for each of fiscal years 2005 through 2009.’’. 

15 CHAPTER 2—ENCOURAGING VACCINE 

16 PRODUCTION CAPACITY 

17 SEC. 2121. INCENTIVES FOR THE CONSTRUCTION OF VAC18 CINE MANUFACTURING FACILITIES. 

19 (a) VACCINE MANUFACTURING FACILITIES INVEST20 MENT TAX CREDIT.— 

21 (1) ALLOWANCE OF CREDIT.—Section 46 of the 

22 Internal Revenue Code of 1986 (relating to amount 

23 of investment credit) is amended by striking ‘‘and’’ 

24 at the end of paragraph (1), by striking the period 

25 at the end of paragraph (2) and inserting ‘‘, and’’, 
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1 and by adding at the end the following new para2 graph: 

3 ‘‘(3) the vaccine manufacturing facilities invest4 ment credit.’’. 

5 (2) AMOUNT OF CREDIT.—Subpart E of part 

6 IV of subchapter A of chapter 1 of such Code (relat7 ing to rules for computing investment credit) is 

8 amended by inserting after section 48 the following 

9 new section: 

10 ‘‘SEC. 48A. VACCINE MANUFACTURING FACILITIES CREDIT. 

11 ‘‘(a) IN GENERAL.—For purposes of section 46, the 

12 influenza vaccine manufacturing facilities investment cred13 it for any taxable year is an amount equal to 20 percent 

14 of the qualified investment for such taxable year. 

15 ‘‘(b) QUALIFIED INVESTMENT.— 

16 ‘‘(1) IN GENERAL.—For purposes of subsection 

17 (a), the qualified investment for any taxable year is 

18 the basis of each influenza vaccine manufacturing 

19 facilities property placed in service by the taxpayer 

20 during such taxable year. 

21 ‘‘(2) VACCINE MANUFACTURING FACILITIES

22 PROPERTY.—For purposes of this section, the term 

23 ‘influenza vaccine manufacturing facilities property’ 

24 means real and tangible personal property— 
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1 ‘‘(A)(i) the original use of which com2 mences with the taxpayer, or 

3 ‘‘(ii) which is acquired through purchase 

4 (as defined by section 179(d)(2)), 

5 ‘‘(B) which is depreciable under section 

6 167, 

7 ‘‘(C) which is used for the manufacture, 

8 distribution, or research and development of 

9 vaccines, and 

10 ‘‘(D) which is in compliance with any 

11 standards and regulations which are promul12 gated by the Food and Drug Administration, 

13 the Occupational Safety and Health Adminis14 tration, or the Environmental Protection Agen15 cy and which are applicable to such property. 

16 ‘‘(c) CERTAIN PROGRESS EXPENDITURE RULES

17 MADE APPLICABLE.—Rules similar to rules of subsections 

18 (c)(4) and (d) of section 46 (as in effect on the day before 

19 the date of the enactment of the Revenue Reconciliation 

20 Act of 1990) shall apply for purposes of this subsection. 

21 ‘‘(d) TERMINATION.—This subsection shall not apply 

22 to any property placed in service after December 31, 

23 2009.’’. 

24 (b) TECHNICAL AMENDMENTS.— 
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1 (1) Clause (iii) of section 49(a)(1)(C) of such 

2 Code is amended to read as follows: 

3 ‘‘(iii) the basis of any vaccine manu4 facturing facilities property.’’. 

5 (2) Subparagraph (E) of section 50(a)(2) of 

6 such Code is amended by inserting ‘‘or 48A(c)’’ be7 fore the period. 

8 (3) The table of sections for subpart E of part 

9 IV of subchapter A of chapter 1 of such Code is 

10 amended by inserting after the item relating to sec11 tion 48 the following: 

‘‘Sec. 48A. Vaccine manufacturing facilities credit.’’. 

12 (c) EFFECTIVE DATE.—The amendments made by 

13 this section shall apply to property placed in service after 

14 December 31, 2004, under rules similar to the rules of 

15 section 48(m) of the Internal Revenue Code of 1986 (as 

16 in effect on the day before the date of enactment of the 

17 Revenue Reconciliation Act of 1990). 

18 CHAPTER 3—ENSURING SUFFICIENT FLU 

19 VACCINE SUPPLY 

20 SEC. 2131. VACCINE SUPPLY. 

21 Title XXI of the Public Health Service Act (42 

22 U.S.C. 300aa–1 et seq.) is amended by adding at the end 

23 the following: 
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1 ‘‘Subtitle 3—Influenza Vaccine 

2 ‘‘VACCINE SUPPLY

3 ‘‘SEC. 2141. (a) REQUESTS FOR MORE DOSES.— 

4 ‘‘(1) IN GENERAL.—Not later than March 15 of 

5 each year, the Secretary shall enter into contracts 

6 with manufacturers to produce such additional doses 

7 of the influenza vaccine as determined necessary by 

8 the Secretary. 

9 ‘‘(2) CONTENT OF CONTRACT.—A contract for 

10 additional doses shall provide that the manufacturer 

11 will be compensated by the Secretary at an equitable 

12 rate negotiated by the Secretary and the manufac13 turer for any doses that— 

14 ‘‘(A) were not sold by the manufacturer 

15 through routine market mechanisms at the end 

16 of the influenza season for that year; and 

17 ‘‘(B) were requested by the Secretary to be 

18 produced by such manufacturer. 

19 ‘‘(3) WHEN SUCH VACCINE PURCHASES

20 SHOULD TAKE PLACE.—The Secretary may purchase 

21 from the manufacturer the doses for which it has 

22 contracted at any time after which it is determined 

23 by the Secretary, in consultation with the manufac24 turer, that the doses will likely not be absorbed by 

25 the private market. 
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1 ‘‘(b) CONTINGENCY PLAN.—The Secretary shall en2 courage States to develop a contingency plan, in coordina3 tion with the Department of Health and Human Services, 

4 for maximizing influenza immunization for high-risk popu5 lations in the event of a delay or shortage of the influenza 

6 vaccine. 

7 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 

8 are authorized to be appropriated to carry out this section 

9 such sums as may be necessary.’’. 

10 CHAPTER 4—PREPARING FOR A 

11 PANDEMIC OR EPIDEMIC 

12 SEC. 2141. PREPARATION FOR INFLUENZA PANDEMIC OR 

13 EPIDEMIC; ANTI-VIRALS SUPPLY. 

14 Subtitle 3 of title XXI of the Public Health Service 

15 Act, as added by section 2131, is amended by adding at 

16 the end the following: 

17 ‘‘PREPARATION FOR INFLUENZA PANDEMIC OR EPIDEMIC

18 ‘‘SEC. 2142. (a) ESTABLISHMENT OF A PROTOCOL.— 

19 The Secretary, acting through the Director of the Na20 tional Vaccine Program (referred to in this section as the 

21 ‘Director of the Program’), shall continue progress on the 

22 pandemic preparedness plan and, in consultation with the 

23 Director of the Centers for Disease Control and Preven24 tion, establish a protocol to attempt to prevent, prepare 

25 for, and respond to an influenza pandemic or epidemic. 
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1 Such protocol shall be updated as determined appropriate 

2 by the Director of the Program. 

3 ‘‘(b) CONTENTS OF PROTOCOL.—The protocol estab4 lished under subsection (a) shall— 

5 ‘‘(1) improve upon the current influenza vac6 cines and production and dissemination methods; 

7 and 

8 ‘‘(2) address— 

9 ‘‘(A) methods to coordinate dissemination 

10 of the influenza vaccine to key populations in 

11 the event of an influenza pandemic or epidemic; 

12 ‘‘(B) expansion of influenza vaccine manu13 facturing capacity (including making advance 

14 arrangements for ensuring the availability of 

15 raw materials) to respond to the needs of the 

16 United States during an influenza pandemic or 

17 epidemic; 

18 ‘‘(C) alternative ways to manufacture or 

19 produce the influenza vaccine; 

20 ‘‘(D) alternative methods to prevent the 

21 spread of, and complications associated with, 

22 influenza, including anti-viral medications; 

23 ‘‘(E) vaccine manufacturing capacity, pro24 duction, and dissemination to improve pre-
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1 paredness for immediate pandemic threats, 

2 which may include avian influenza; 

3 ‘‘(F) a tracking method for publicly and 

4 privately sold doses of the influenza vaccine to 

5 enable the Director of the Program to deter6 mine, after consultation with manufacturers of 

7 the influenza vaccine, how much supply is in 

8 circulation in the case of an influenza pandemic 

9 or epidemic; and 

10 ‘‘(G) other issues determined by the Direc11 tor of the Program to be appropriate. 

12 ‘‘(c) COORDINATION; PREPARATION; PREVENTION.— 

13 In establishing the protocol under subsection (a), the Di14 rector of the Program shall— 

15 ‘‘(1) coordinate with health care providers, 

16 manufacturers, research institutions, health care or17 ganizations, and other expert stakeholders; 

18 ‘‘(2) continue building international and na19 tional surveillance capacity; 

20 ‘‘(3) continue to engage in epidemiological stud21 ies and research on novel influenza viruses; and 

22 ‘‘(4) assist States with preparedness activities 

23 for a rapid State and local response to an influenza 

24 pandemic, including exploring methods of making 
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1 the influenza vaccine more accessible to the general 

2 population. 

3 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

4 are authorized to be appropriated to carry out this section 

5 $150,000,000 for each of fiscal years 2005 through 2009. 

6 ‘‘SEC. 2143. INFLUENZA ANTI-VIRALS SUPPLY. 

7 ‘‘(a) IN GENERAL.—The Secretary shall establish a 

8 stockpile of anti-virals to use for rapid response to an in9 fluenza outbreak. 

10 ‘‘(b) AMOUNT.—The stockpile established under sub11 section (a) shall be of sufficient quantity to treat not less 

12 than 2 percent of the population of the United States.’’. 

13 CHAPTER 5—REPORT AND 

14 ADMINISTRATION 

15 SEC. 2151. REPORT TO CONGRESS. 

16 Not later than 180 days after the date of enactment 

17 of this Act, the Director of the Centers for Disease Control 

18 and Prevention, in consultation with the Assistant Sec19 retary for Medical Readiness and Response of the Depart20 ment of Homeland Security and the Director of the Na21 tional Institute for Allergy and Infectious Disease of the 

22 National Institutes of Health, shall submit a report to 

23 Congress that describes alternatives to traditional vaccines 

24 and anti-viral therapeutics for viral diseases, including 

25 negative immunomodulation compounds that partially 
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1 suppress a macrophage-dependent innate immune re2 sponse of an individual to viral pathogens, in order to de3 crease morbidity and mortality from an excessive immune 

4 response. 

5 SEC. 2152. SIMPLIFIED ADMINISTRATION OF VACCINE SUP6 PLY. 

7 Section 1928(d)(6) of the Social Security Act (42 

8 U.S.C. 1396s(d)(6)) is amended by inserting before the 

9 last sentence the following: ‘‘The Secretary may sell such 

10 quantities of vaccines from such supply as the Secretary 

11 determines appropriate. Proceeds received from such sales 

12 shall be available to the Secretary solely for the purposes 

13 of this section and shall remain available until expended. 

14 SEC. 2153. MEDICARE COVERAGE OF VACCINES AND PRO15 PHYLAXIS AS COUNTERMEASURES. 

16 (a) FINDINGS.—Congress finds the following: 

17 (1) In the event of a bioterrorism attack or in18 fectious disease outbreak, it is in the public interest 

19 to ensure appropriate and timely voluntary utiliza20 tion of critical vaccines and other prophylaxis 

21 against these pathogens. 

22 (2) Such voluntary utilization in such emer23 gency will be increased if the vaccines and other pro24 phylaxis are covered under Medicare Part B. 
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1 (3) Such voluntary utilization reduces adverse 

2 impacts on the public health infrastructure and as3 sists in containing the pathogen without the need to 

4 impose quarantines. 

5 (4) Coverage and reimbursement for most vac6 cines and other prophylaxis currently is not available 

7 under Medicare Part B. 

8 (5) Medicare Part B does cover diagnostic serv9 ices as well as drugs and biological products that are 

10 administered incident to a physician’s services that 

11 are not usually self-administered by the patient as 

12 long as they are ‘‘reasonable and necessary for the 

13 diagnosis or treatment of illness or injury or to im14 prove the function of a malformed body member’’. 

15 (6) The public interest would be served best by 

16 extending Medicare Part B coverage and reimburse17 ment to vaccines and prophylaxis that would combat 

18 a wide variety of chemical and biological agents, tox19 ins, nuclear and radiological materials, and emerging 

20 infectious diseases. 

21 (b) AMENDMENT TO THE SOCIAL SECURITY ACT TO

22 EXTEND COVERAGE.—Section 1861(s)(10)(A) of the So23 cial Security Act (42 U.S.C. 1396x(s)(10)(A)) is amended 

24 by inserting ‘‘, a vaccine or prophylaxis against any of the 

25 agents, toxins, or materials on the list developed by the 
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1 Secretary under section 319F–3(f) of the Public Health 

2 Service Act and its administration’’ after ‘‘pneumococcal 

3 vaccine and its administration’’. 

4 (c) EFFECTIVE DATE.—The amendment made by 

5 subsection (b) shall apply to items furnished on or after 

6 the date of enactment of this Act. 

7 TITLE XXII—GAAP ACCOUNTING 

8 FOR VACCINE REVENUE REC9 OGNITION 

10 SEC. 2201. GAAP ACCOUNTING FOR VACCINE PROCURE11 MENT. 

12 Not later than 180 days after the date of enactment 

13 of this Act, the Secretary of Health and Human Services 

14 and the Secretary of Homeland Security, in consultation 

15 with appropriate representatives from the Securities and 

16 Exchange Commission (as determined by such Secre17 taries) shall meet to determine— 

18 (1) how contracts entered into under the 

19 Project BioShield Act of 2004 and the Project Bio20 Shield II Act of 2005 (and the amendments made 

21 by such Acts) may be structured so that a person 

22 that enters such a contract can recognized revenue 

23 under General Acceptable Accounting Principles ac24 counting rules; or 
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1 (2) how the Securities and Exchange Commis2 sion may interpret its Staff Accounting Bulletin 

3 Number 104 of December 17, 2003, to achieve the 

4 result described under paragraph (1). 

5 TITLE XXIII—HUMAN CLINICAL 

6 TRIALS AND DRUGS FOR 

7 RARE DISEASES AND CONDI8 TIONS 

9 SEC. 2301. EXPANDED HUMAN CLINICAL TRIALS QUALI10 FYING FOR ORPHAN DRUG CREDIT. 

11 (a) EXPANDED HUMAN CLINICAL TRIALS QUALI12 FYING FOR ORPHAN DRUG CREDIT.— 

13 (1) IN GENERAL.—Subclause (I) of section 

14 45C(b)(2)(A)(ii) of the Internal Revenue Code of 

15 1986 is amended to read as follows: 

16 ‘‘(I) after the date that the appli17 cation is filed for designation under 

18 such section 526, and’’. 

19 (2) CONFORMING AMENDMENTS.—Clause (i) of 

20 section 45C(b)(2)(A) of the Internal Revenue Code 

21 of 1986 is amended by inserting ‘‘which is’’ before 

22 ‘‘being’’ and by inserting before the comma at the 

23 end ‘‘and which is designated under section 526 of 

24 such Act’’. 
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1 (3) EFFECTIVE DATE.—The amendments made 

2 by this subsection shall apply to amounts paid or in3 curred after December 31, 2003. 

4 (b) PUBLICATION OF FILING AND APPROVAL OF RE5 QUESTS FOR DESIGNATION OF DRUGS FOR RARE DIS6 EASES OR CONDITIONS.—Subsection (c) of section 526 of 

7 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

8 360bb) is amended to read as follows: 

9 ‘‘(c) Not less than monthly, the Secretary shall pub10 lish in the Federal Register, and otherwise make available 

11 to the public, notice of requests for designation of a drug 

12 under subsection (a) and approvals of such requests. Such 

13 notice shall include— 

14 ‘‘(1) the name and address of the manufacturer 

15 and the sponsor; 

16 ‘‘(2) the date of the request for designation or 

17 of the approval of such request; 

18 ‘‘(3) the nonproprietary name of the drug and 

19 the name of the drug under which an application is 

20 filed under section 505(b) of this Act or section 351 

21 of the Public Health Service Act; 

22 ‘‘(4) the rare disease or condition for which the 

23 designation is requested or approved; and 

24 ‘‘(5) the proposed indication for use of the 

25 product.’’. 
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1 TITLE XXIV—HEALTHCARE SYS2 TEM COLLECTION OF CLIN3 ICAL DATA REGARDING SAFE4 TY AND EFFECTIVENESS OF 

5 COUNTERMEASURES 

6 SEC. 2401. FINDINGS; DEFINITIONS. 

7 (a) PURPOSE.—The purpose of this title is to provide 

8 necessary protocols and funding to ensure that real time 

9 clinical data about a countermeasure, as it is utilized, may 

10 be extracted in order to assess the appropriate role of such 

11 countermeasure in responding to a terror attack or out12 break of infectious disease. 

13 (b) DEFINITIONS.—In this title: 

14 (1) CLINICAL COUNTERMEASURES DELIVERY.— 

15 The term ‘‘clinical countermeasures delivery’’ refers 

16 to the coordinated development, implementation, and 

17 evaluation of consistent clinical countermeasures 

18 policies, diagnostic procedures and protocols, edu19 cation and training, and necessary medical capacities 

20 (such as administrative support, infrastructure in21 cluding healthcare epidemiology, laboratories, infor22 mation systems, leadership and expert personnel, re23 search capability, equipment and supplies) for the 

24 healthcare delivery and response community within a 

25 defined geographic area that takes into account pop-
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1 ulations at risk and vulnerabilities to pathogens and 

2 agents. 

3 (2) CLINICAL COUNTERMEASURES DELIVERY

4 CENTER.—The term ‘‘clinical countermeasures deliv5 ery center’’ means a nonprofit health or public 

6 health, medical center, or public hospital, including 

7 an academic health center or other similar organiza8 tion, that dedicates a significant percentage of its re9 sources for the coordination of healthcare delivery, 

10 research, education, and integrated community serv11 ices, as determined by the Assistant Secretary for 

12 Medical Readiness and Response of the Department 

13 of Homeland Security. 

14 (3) EMERGENCY SITUATION.—The term ‘‘emer15 gency situation’’ means a natural or man-made 

16 event that requires an emergency response and is 

17 designated as an emergency by the President, a Gov18 ernor through an appropriate State emergency man19 agement coordinator, local government executive, or 

20 a county emergency manager (only with respect to 

21 a condition for a period not to exceed 24 hours 

22 pending review and approval by a Governor) in 

23 which clinical countermeasures may or will be uti24 lized. 
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1 (4) HEALTHCARE DELIVERY AND RESPONSE

2 COMMUNITY.—The term ‘‘healthcare delivery and re3 sponse community’’ means individuals, entities, and 

4 institutions that provide— 

5 (A) direct patient healthcare, public health, 

6 or community health; or 

7 (B) emergency medical care, such as emer8 gency medical, fire, and police services. 

9 (5) QUALIFIED CLINICAL COUNTERMEASURES

10 DELIVERY CENTER.—The term ‘‘qualified clinical 

11 countermeasures delivery center’’ means a clinical 

12 countermeasures delivery center that has been cer13 tified under section 2402 as in compliance with the 

14 requirements of section 2403. 

15 (6) ASSISTANT SECRETARY.—The term ‘‘Assist16 ant Secretary’’ means the Assistant Secretary for 

17 Medical Readiness and Response of the Department 

18 of Homeland Security. 

19 SEC. 2402. CERTIFICATION OF CLINICAL COUNTER20 MEASURES DELIVERY CENTERS. 

21 (a) ESTABLISHMENT OF PROGRAM.—The Assistant 

22 Secretary shall establish and administer a program to cer23 tify clinical countermeasures delivery centers as qualified 

24 clinical countermeasures delivery centers for purposes of 

25 ensuring that— 
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1 (1) the coordinated development, implementa2 tion, and evaluation of clinical countermeasures will 

3 precede and follow the utilization of the clinical 

4 countermeasures developed under this Act (or the 

5 amendments made by this Act) or otherwise avail6 able to respond to a biological, chemical, nuclear, ra7 diological, or explosive event or other emergency sit8 uation; and 

9 (2) such countermeasures are delivered to af10 fected and at-risk populations within a therapeuti11 cally effective time period. 

12 (b) APPLICATION.— 

13 (1) IN GENERAL.—To be certified as a qualified 

14 clinical countermeasures delivery center, a clinical 

15 countermeasures delivery center shall submit to the 

16 Assistant Secretary an application at such time, in 

17 such manner, and containing such information as 

18 the Assistant Secretary shall require. 

19 (2) APPROVAL.—In determining whether to ap20 prove an application under paragraph (1), the As21 sistant Secretary shall ensure that the clinical coun22 termeasures delivery center is in compliance with the 

23 criteria developed pursuant to section 2403. 

24 (c) REQUIREMENTS.—Upon approval of an applica25 tion under subsection (b), a qualified clinical counter-
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1 measures delivery center within a specified geographic 

2 area and representing an affected or at risk population, 

3 shall— 

4 (1) during the pre-event phase, develop, test 

5 (through exercises), and have in place plans for clin6 ical countermeasures delivery, in accordance with 

7 section 2404; 

8 (2) during the pre-event phase, prepare, test, 

9 and have in place plans to develop new, and to main10 tain existing, collaborations with members of the 

11 healthcare delivery and response community; 

12 (3) during the event phase, deliver clinical 

13 countermeasures to affected and at-risk populations 

14 in a therapeutically effective time period and provide 

15 medical management and treatment of adverse 

16 events arising from utilization of clinical counter17 measures developed in response to an emergency sit18 uation; 

19 (4) during the event phase, communicate pre20 liminary findings regarding the delivery and efficacy 

21 of clinical countermeasures to appropriate Federal, 

22 State, and local public health authorities; 

23 (5) during the post event phase, have in place 

24 a validated process of metrics and measures for eval25 uating the effectiveness of clinical countermeasures 
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1 through clinical research, including external evalua2 tion, quality assurance and mitigation, and an eval3 uation of the clinical countermeasures delivery cen4 ter’s capability to respond to the needs of popu5 lations at risk and address potential hazard 

6 vulnerabilities; and 

7 (6) during the post-even phase, share informa8 tion about the effectiveness of countermeasures and 

9 the capability of the countermeasure delivery centers 

10 to respond to the event to appropriate Federal, 

11 State, and local public health authorities. 

12 (d) STANDARDS.—The Assistant Secretary shall set 

13 standards to ensure that qualified clinical counter14 measures delivery centers remain prepared to fulfill the 

15 functions described under this section in the event of an 

16 emergency situation. 

17 SEC. 2403. ELIGIBILITY CRITERIA. 

18 (a) IN GENERAL.—The Assistant Secretary shall es19 tablish by regulation criteria for the certification of clinical 

20 countermeasures delivery centers as qualified clinical 

21 countermeasures delivery centers for purposes of this title. 

22 (b) MINIMUM QUALIFICATIONS.—The criteria devel23 oped under subsection (a) shall require that a qualified 

24 clinical countermeasures delivery center— 
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1 (1) be a nonprofit healthcare provider that is 

2 directly affiliated with an accredited medical teach3 ing institution, accredited school of public health, or 

4 an institution of higher education (as defined by sec5 tion 101(a) of the Higher Education Act of 1965 

6 (20 U.S.C. 1001(a))); and 

7 (2) have in place— 

8 (A) plans for clinical countermeasures de9 livery in accordance with section 2404; 

10 (B) collaborating agreements with mem11 bers of its healthcare delivery and response 

12 community; 

13 (C) plans to participate annually in at 

14 least 1 major exercise of plans and systems 

15 demonstrating coordination among representa16 tives of its healthcare delivery and response 

17 community, as evaluated by the Secretary; 

18 (D) operating and managing clinical plans 

19 to deliver healthcare to affected and at risk 

20 populations in response to an emergency situa21 tion; and 

22 (E) a validated process— 

23 (i) of metrics and measures for evalu24 ating the effectiveness of the delivery cen25 ter’s capability to meet the needs of af-
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1 fected and at risk populations and address 

2 potential vulnerabilities to hazards; and 

3 (ii) for sharing the results and data 

4 from the plans and activities required 

5 under this subsection. 

6 SEC. 2404. POLICIES, PROCEDURES, AND PROTOCOLS FOR 

7 THE DELIVERY OF CLINICAL COUNTER8 MEASURES. 

9 (a) IN GENERAL.—The Assistant Secretary, in con10 sultation with the Commissioner of the Food and Drug 

11 Administration, the Director of the Centers for Disease 

12 Control and Prevention, the Health Resources Services 

13 Administration, the Commissioner of Medicare and Med14 icaid, and other regulatory and accreditation agencies, as 

15 appropriate, shall establish policies, procedures, and proto16 cols to ensure the coordinated delivery of clinical counter17 measures as described in section 2402(c). 

18 (b) DESCRIPTION.—The policies, procedures, and 

19 protocols established under subsection (a) shall be de20 signed to— 

21 (1) foster cooperation and coordination among 

22 qualified clinical countermeasures delivery centers; 

23 (2) ensure the implementation, delivery and 

24 evaluation of clinical countermeasures among the 

25 healthcare delivery and response community; and 
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1 (3) identify and address the clinical, oper2 ational, ethical, and legal issues that may arise dur3 ing an emergency situation. 

4 (c) DUTIES OF CENTERS.—The qualified clinical 

5 countermeasures delivery centers shall— 

6 (1) meet the requirements described in subpara7 graphs (A) and (B) of section 2403(b)(2); 

8 (2) participate annually in at least 1 major ex9 ercise of plans and systems demonstrating the co10 ordination of clinical countermeasures among rep11 resentatives of its healthcare delivery and response 

12 community; 

13 (3) have in place operating and clinical plans— 

14 (A) to deliver clinical countermeasures 

15 within a therapeutically effective time period to 

16 affected and at risk populations in response to 

17 an emergency situation; and 

18 (B) for the medical management and treat19 ment of adverse events arising from utilization 

20 of clinical countermeasures developed in re21 sponse to an emergency situation; and 

22 (4) have in place a validated process— 

23 (A) of metrics and measures for— 

24 (i) evaluating the effectiveness of clin25 ical countermeasures, including external 
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1 evaluation, quality assurance, and mitiga2 tion; and 

3 (ii) evaluating the clinical counter4 measures delivery center’s capability to 

5 meet the needs of affected and at risk pop6 ulations and address potential 

7 vulnerabilities to hazards; and 

8 (B) for sharing the results and data from 

9 the plans and activities required under this sub10 section. 

11 SEC. 2405. INCENTIVES FOR QUALIFIED CLINICAL COUN12 TERMEASURES DELIVERY CENTERS. 

13 A clinical countermeasures delivery center that is cer14 tified by the Assistant Secretary as a qualified clinical 

15 countermeasures delivery center— 

16 (1) shall be entitled to reimbursement— 

17 (A) for the costs associated with prepared18 ness for clinical countermeasures delivery and 

19 maintaining readiness for a healthcare emer20 gency requiring the use of clinical counter21 measures, including training exercises and edu22 cational programs; 

23 (B) for costs associated with the imple24 mentation, delivery, and evaluation of clinical 

25 countermeasures in the event of a healthcare 
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1 emergency in which clinical countermeasures, 

2 including those developed under this Act (or the 

3 amendments made by this Act), are utilized; 

4 and 

5 (C) for costs associated with the post-event 

6 initiatives involved with the delivery of clinical 

7 countermeasures in the event of a healthcare 

8 emergency in which clinical countermeasures, 

9 including those developed under this Act (or the 

10 amendments made by this Act), are utilized; 

11 and 

12 (2) at the discretion of the Assistant Secretary, 

13 may receive 1 or more of the following: 

14 (A) Bonus payment under the Medicare 

15 program under title XVIII of the Social Secu16 rity Act (42 U.S.C. 1395 et seq.) for the reim17 bursement of expenditures incurred in connec18 tion with the implementation of activities under 

19 this title. 

20 (B) Increased graduate medical education 

21 reimbursement for expenditures incurred in 

22 connection with the implementation of activities 

23 under this title. 

24 (C) The application and receipt of sur25 charges with respect to reimbursements under 
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1 the Medicare or Medicaid programs under title 

2 XVIII or XIX of the Social Security Act (42 

3 U.S.C. 1395 or 1396 et seq.) paid to the quali4 fied clinical countermeasures delivery centers. 

5 (D) Participation in a program to receive 

6 temporary personnel replacements, salary reim7 bursements, and training cost reimbursement, 

8 to be applied to the personnel of qualified clin9 ical countermeasures delivery centers that 

10 choose to obtain specialized training in emer11 gency preparedness or that want to obtain spe12 cial certifications. 

13 (E) Malpractice and tort liability indem14 nification for the qualified clinical counter15 measures delivery centers and the personnel 

16 supporting such centers for legal fees and judg17 ments incurred in connection with the imple18 mentation of activities under this title. 

19 (F) Worker’s compensation indemnification 

20 with respect to qualified clinical counter21 measures delivery centers’ personnel in connec22 tion with the implementation of programs under 

23 this title during periods of training and emer24 gency situations. 
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1 (G) Notwithstanding the requirements of 

2 section 1867 of the Social Security Act (42 

3 U.S.C. 1395dd), commonly known as the Emer4 gency Medical Treatment and Active Labor Act, 

5 the ability of qualified clinical countermeasures 

6 delivery centers to pre-triage patients during an 

7 emergency situation, including triaging based 

8 on nonemergent conditions to other hospitals, 

9 ambulatory facilities, or other appropriate 

10 healthcare entities. 

11 (H) Indemnification by the Federal Gov12 ernment for legal fees incurred by the qualified 

13 clinical countermeasures delivery centers during 

14 an emergency situations, as well as worker’s 

15 compensation and overall liability coverage dur16 ing such a situation and during periods of 

17 training. 

18 (I) The assistance of Federal personnel or 

19 armed forces personnel for the planning and 

20 support of training and training exercises for 

21 the personnel of the qualified clinical counter22 measures delivery centers. 

23 (J) The provision of family support serv24 ices for workers, including emergency manage25 ment and public health agencies personnel, sup-
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1 porting the center during an emergency situa2 tion to allow for communication access to such 

3 workers during such situation, priority standing 

4 for access to vaccines and other recommended 

5 interventions, and other services to help work6 ers function effectively in such a situation. 

7 SEC. 2406. AUTHORIZATION OF APPROPRIATIONS. 

8 There are authorized to be appropriated such sums 

9 as may be necessary to carry out this title. 

10 TITLE XXV—CENTERS FOR DIS11 EASE CONTROL AND PREVEN12 TION 

13 SEC. 2501. GLOBAL DISEASE DETECTION TRUST FUND. 

14 (a) IN GENERAL.— 

15 (1) ESTABLISHMENT OF FUND.—There is es16 tablished within the Centers for Disease Control and 

17 Prevention a Global Disease Detection Trust Fund 

18 (referred to in this title as the ‘‘Detection Trust 

19 Fund’’). 

20 (2) ADMINISTRATION.—The Detection Trust 

21 Fund shall be administered by the Director of the 

22 Centers for Disease Control and Prevention. 

23 (3) PURPOSES.—The purposes of the Detection 

24 Trust Fund are to— 
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1 (A) detect, verify, and respond to infec2 tious disease outbreaks around the world more 

3 quickly, including threats such as avian influ4 enza and the development of antimicrobial re5 sistance that emerge outside the United States; 

6 (B) control intentional or naturally occur7 ring health threats at their origin and prevent 

8 international spread; 

9 (C) protect the health and safety of United 

10 States citizens and officials traveling or living 

11 abroad; and 

12 (D) protect the economic interests of the 

13 United States and its partners from threats to 

14 health. 

15 (b) USE OF FUND.— 

16 (1) IN GENERAL.—The Director of the Centers 

17 for Disease Control and Prevention may expend not 

18 more than $250,000,000 in each fiscal year from the 

19 Detection Trust Fund on global disease detection ac20 tivities, which may include— 

21 (A) conducting— 

22 (i) disease surveillance activities; 

23 (ii) field investigations; 

24 (iii) training and development activi25 ties; and 
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1 (iv) research on methods and ap2 proaches for detection and control of 

3 threats to health described in subsection 

4 (a)(3); 

5 (B) developing information and commu6 nications technology; 

7 (C) improving infectious disease epidemi8 ology; 

9 (D) providing technical assistance for dis10 ease prevention and control programs; 

11 (E) ensuring the capacity to prepare for 

12 and respond to emerging and unknown public 

13 health threats and emergencies; and 

14 (F) developing and maintaining of labora15 tory capacity. 

16 (2) LIMITATION.—Amounts expended from the 

17 Detection Trust Fund shall not be funded through 

18 reductions in the annual appropriations for related 

19 activities of the Centers for Disease Control and 

20 Prevention. 

21 (c) AUTHORIZATION OF APPROPRIATIONS.—There 

22 are authorized to be appropriated $1,250,000,000 to the 

23 Detection Trust Fund to carry out this section. 
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1 SEC. 2502. ENVIRONMENTAL MICROBIOLOGY FACILITY 

2 STUDY AND REPORT. 

3 Not later than 6 months after the date of enactment 

4 of this Act, the Director of the Centers for Disease Control 

5 and Prevention shall— 

6 (1) conduct a study on the feasibility of devel7 oping an environmental microbiology facility as part 

8 of the National Interagency Biodefense Campus at 

9 Fort Detrick, Maryland; and 

10 (2) submit to Congress a report that describes 

11 the findings of the study under paragraph (1), in12 cluding— 

13 (A) the need for such a facility and the po14 tential benefits of developing such a facility as 

15 part of the Interagency campus; 

16 (B) the feasibility of constructing such a 

17 facility, and 

18 (C) the projected cost and timetable for 

19 the construction of such a facility. 

20 SEC. 2503. ENFORCEMENT OF QUARANTINES. 

21 (a) PENALTIES.—Section 368 (42 U.S.C. 271) is 

22 amended— 

23 (1) in subsection (a), by striking ‘‘$1,000 or by 

24 imprisonment for not more than one year’’ and in25 serting ‘‘$250,000 or by imprisonment for not more 

26 than 10 years’’; and 
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1 (2) in subsection (b), by striking ‘‘$5,000’’ and 

2 inserting ‘‘$1,000,000’’. 

3 (b) PANEL PHYSICIAN QUALITY CONTROL.—Section 

4 361 of the Public Health Service Act (42 U.S.C. 264) is 

5 amended by adding at the end the following: 

6 ‘‘(f) Where the United States enters into agreements, 

7 contracts, or other arrangements with physicians or other 

8 healthcare providers and laboratories in foreign countries 

9 for the purpose of conducting health screening on aliens 

10 seeking temporary or permanent residence in the United 

11 States, the Secretary shall evaluate each such physician 

12 or provider on an annual basis to certify that the physician 

13 or provider adequately complies with applicable regula14 tions governing the medical screening of applicants for 

15 entry into the United States. The Secretary may assess 

16 certification or user fees to support the annual evaluation, 

17 quality control, and certification of panel physicians per18 forming such foreign medical screenings.’’. 

19 SEC. 2504. EDUCATIONAL CAMPAIGN AT THE CENTERS FOR 

20 DISEASE CONTROL AND PREVENTION. 

21 (a) IN GENERAL.—The Director of the Centers for 

22 Disease Control and Prevention shall, in consultation with 

23 relevant stakeholders, carry out a 2-phase, national edu24 cational campaign to make available information about the 

25 possible public health measures that might be imple-
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1 mented in the event of a pandemic outbreak or a bioterror 

2 attack involving an infectious disease. 

3 (b) CAMPAIGN CONTENT.— 

4 (1) IN GENERAL.—The campaign established 

5 under subsection (a) may include information re6 garding— 

7 (A) the circumstances under which a range 

8 of public health measures might be imple9 mented; 

10 (B) the concepts of person-to-person 

11 spread, quarantine, isolation, and movement re12 striction; 

13 (C) mass pre- and post-exposure prophy14 laxis, the use of off-label drugs, and other ex15 traordinary measures to protect the public 

16 health; 

17 (D) the rationale and benefits to the public 

18 of implementing such public health measures; 

19 and 

20 (E) the legal rights of citizens in the event 

21 such public health measures are implemented. 

22 (2) CAMPAIGN PHASE 1.— 

23 (A) IN GENERAL.—In Phase 1 of the cam24 paign established under subsection (a), the Di25 rector of the Centers for Disease Control and 
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1 Prevention shall consult with a diverse advisory 

2 panel in the preparation of nationally standard3 ized messages and guidance about the range of 

4 medical and nonmedical interventions to inter5 rupt disease transmission. 

6 (B) COMPOSITION OF ADVISORY PANEL.— 

7 The advisory panel consulted under subpara8 graph (A) shall include— 

9 (i) representatives of State and local 

10 governments and nongovernmental public 

11 health agencies; 

12 (ii) public health experts and medical 

13 practitioners who have real-world experi14 ence in crisis management and risk com15 munication; 

16 (iii) business leaders; 

17 (iv) members of the lay public; and 

18 (v) subject matter experts in bioethics, 

19 risk communication, health education, com20 munity organization, advertising, and pub21 lic relations. 

22 (C) COLLECTION OF INFORMATION.—To 

23 direct the deliberations of the advisory panel, 

24 the Director of the Centers for Disease Control 

25 and Prevention shall collect and synthesize ex-
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1 tant information regarding community-level dis2 ease containment measures, including assess3 ment of interventions during the SARS out4 break. 

5 (3) CAMPAIGN PHASE 2.— 

6 (A) PURPOSE.—The purpose of Phase 2 of 

7 the campaign established under subsection (a) 

8 shall be to augment at the State and local level 

9 nationally standardized messages to address 

10 specific community needs and concerns. 

11 (B) ESTABLISHMENT OF GRANT.— 

12 (i) IN GENERAL.—The Director of the 

13 Centers for Disease Control and Preven14 tion shall award grants to 5 local health 

15 departments (that are regionally and de16 mographically diverse) to design and de17 liver educational campaigns targeted for 

18 their community with respect to the plans 

19 of the health departments for imple20 menting a range of public health interven21 tions in the context of a pandemic out22 break or biological attack. 

23 (ii) APPLICATION.—Local public 

24 health departments shall submit to the 

25 Secretary an application to receive a grant 
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1 under clause (i) at such time, in such man2 ner, and containing such information as 

3 the Secretary may require. 

4 (c) AUTHORIZATION OF APPROPRIATIONS.—There 

5 are authorized to be appropriated $20,000,000 for each 

6 of fiscal years 2006 through 2010 to carry out this sec7 tion. 

8 TITLE XXVI—ZOONOTIC DISEASE 

9 SURVEILLANCE 

10 SEC. 2601. ZOONOTIC DISEASE SURVEILLANCE. 

11 (a) FINDINGS.—Congress makes the following find12 ings: 

13 (1) Seventy percent of the known bioterrorist 

14 agents are zoonotic. 

15 (2) Emerging infectious diseases such as SARS, 

16 monkeypox, and West Nile virus have emerged from 

17 animal origins. 

18 (2) Early warning of impending zoonotic dis19 ease outbreaks has failed in sentinel animal popu20 lations during zoonotic outbreaks such as SARS, 

21 monkeypox, and West Nile virus. 

22 (3) There is no way to predict what species 

23 might serve as sentinels in emerging infectious dis24 eases or bioterrorist events. 
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1 (4) Many animals, such as dogs, cats, and ex2 otic pets, do not fall under the jurisdiction of any 

3 Federal agency. 

4 (5) There is a lack of focus on the detection of 

5 zoonotic threats in sentinel or reservoir animal popu6 lations prior to human involvement. 

7 (6) There is a continued inability to share real8 time data across the human and veterinary agencies 

9 on zoonotic threats. 

10 (b) ESTABLISHMENT OF WORKING GROUP.—The 

11 Secretary of Homeland Security, in consultation with the 

12 Secretary of Health and Human Services, the Secretary 

13 of Agriculture, the Secretary of the Interior, and the Sec14 retary of Defense shall establish a Zoonotic Disease Work15 ing Group within the Department of Homeland Security 

16 (referred to in this section as the ‘‘Working Group’’). 

17 (c) DUTIES OF WORKING GROUP.— 

18 (1) IN GENERAL.—The Working Group shall 

19 conduct a study of all matters relating to the cre20 ation of an integrated (human and animal) real-time 

21 zoonotic disease surveillance network and make rec22 ommendations that address gaps in surveillance ac23 tivities. 

24 (2) MATTERS STUDIED.—The Working Group 

25 shall— 
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1 (A) evaluate the status of zoonotic disease 

2 surveillance by Federal agencies and the private 

3 sector as of the date of enactment of this Act; 

4 (B) identify— 

5 (i) existing bioterrorism funds in Fed6 eral and State agencies; 

7 (ii) budgets that could be redirected 

8 toward improving the ability to detect and 

9 report zoonotic threats across species han10 dled by veterinary and wildlife institutions; 

11 and 

12 (iii) existing laboratory facilities for 

13 zoo animals, pets, and exotic collections 

14 that could be networked, equipped, and 

15 funded for such purpose; and 

16 (C) consult private sector representatives, 

17 including those with expertise on non-agricul18 tural species, exotic pets, and zoo animals, rep19 resentatives of State and local public health 

20 agencies, and representatives from veterinarians 

21 and laboratories. 

22 (3) SUBMISSION OF REPORT.—Not later than 8 

23 months after the date of enactment of this Act, the 

24 Working Group shall submit a report to the Sec-
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1 retary of Homeland Security with respect to its find2 ings and recommendations under this section. 

3 TITLE XXVII—COUNTER4 MEASURES AGAINST 

5 AGROTERRORISM 

6 SEC. 2701. FINDINGS. 

7 Congress finds that— 

8 (1) agriculture is important to the social and 

9 economic stability of the United States; 

10 (2) in 2001, food production constituted 9.7 

11 percent of the gross domestic product of the United 

12 States, generating cash receipts in excess of 

13 $991,000,000,000; 

14 (3) the agriculture production and food indus15 tries are vulnerable to deliberate agroterrorist acts 

16 and naturally occurring disease disruption; 

17 (4) practices that heighten this vulnerability in18 clude— 

19 (A) the highly intensive and concentrated 

20 nature of agribusiness in the United States, 

21 which increases the potential speed with which 

22 a disease can spread; 

23 (B) the insufficiency of agricultural secu24 rity methods and biosurveillance technologies; 
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1 (C) the hesitancy of producers to report 

2 disease outbreaks for fear of uncompensated 

3 culling or quarantine; 

4 (D) the declining pool of veterinarians and 

5 diagnosticians trained to recognize foreign ani6 mal diseases; 

7 (E) larger breeding herds, which reduce in8 dividual animal health observations and may 

9 cause illnesses to remain undetected; and 

10 (F) inadequate laboratory diagnostic capa11 bility at the national and local levels; 

12 (5)(A) countermeasures should be developed to 

13 both prevent and control agroterrorism; 

14 (B) incentives under title III (and amendments 

15 made by that title) should be made available to per16 sons who develop and manufacture those counter17 measures; 

18 (C) threats to biosecurity should be identified 

19 through cooperative decisions made by the Secretary 

20 and the Secretary of Homeland Security; 

21 (D) the Secretary regulates and approves bio22 logical and chemical agents and toxins under the 

23 Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.); and 

24 (E) the Secretary of Health and Human Serv25 ices, acting through the Center for Veterinary Medi-
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1 cine of the Food and Drug Administration, regulates 

2 and approves new animal drugs under section 512 of 

3 the Federal Food, Drug, and Cosmetic Act (21 

4 U.S.C. 360b); 

5 (6) preventative countermeasures (including all 

6 equipment, materials, drugs, personnel, and training 

7 necessary to interdict the spread of animal and plant 

8 diseases efficiently and effectively) should include— 

9 (A) increased funding for the Animal and 

10 Plant Health Inspection Service to increase 

11 training and better protect the borders of the 

12 United States; 

13 (B) increased funding for exotic animal 

14 and plant disease research conducted in coun15 tries in which exotic diseases are endemic; 

16 (C) improved use, by persons under con17 tract with the Federal Government to develop 

18 countermeasures, of appropriate containment 

19 facilities controlled by the Federal Government 

20 (such as the National Veterinary Disease Lab21 oratory in Ames, Iowa or Plum Island, New 

22 York); and 

23 (D) increased funding for vaccine and anti24 biotic research; 

25 (7) control countermeasures should include— 
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1 (A) recruiting, training, and equipping 

2 field personnel; 

3 (B) developing rapid and specific diag4 nostic tests; 

5 (C) developing a stockpile of counter6 measures to biological and chemical agents and 

7 toxins of consequence to the agricultural com8 munity, as determined by the Secretary, with 

9 adequate funding for the development of the 

10 stockpile; 

11 (D) researching and stockpiling of 

12 antiviral, antifungal, antibacterial, and vector 

13 control agents; and 

14 (E) a national system of livestock identi15 fication and movement surveillance; and 

16 (8) an effective system of countermeasures 

17 against agroterrorism will require initial centraliza18 tion followed by dissemination of policies and prac19 tices to a local level. 

20 SEC. 2702. DEFINITIONS. 

21 In this Act: 

22 (1) AGRICULTURAL DISEASE.—The term ‘‘agri23 cultural disease’’ means an outbreak of a plant or 

24 animal disease, or a pest infestation, that requires 

25 prompt action in order to prevent injury or damage 
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1 to people, plants, livestock, property, the economy, 

2 or the environment. 

3 (2) AGRICULTURAL DISEASE EMERGENCY.— 

4 The term ‘‘agricultural disease emergency’’ means 

5 an agricultural disease that the Secretary determines 

6 to be an emergency under— 

7 (A) section 415 of the Plant Protection 

8 Act (7 U.S.C. 7715); or 

9 (B) section 10407(b) of the Animal Health 

10 Protection Act (7 U.S.C. 8306(b)). 

11 (3) AGRICULTURE.—The term ‘‘agriculture’’ in12 cludes— 

13 (A) the science and practice of activities 

14 relating to food, feed, and fiber production, 

15 processing, marketing, distribution, use, and 

16 trade; 

17 (B) family and consumer science, nutri18 tion, food science and engineering, agricultural 

19 economics, and other social sciences; and 

20 (C) forestry, wildlife science, fishery 

21 science, aquaculture, floraculture, veterinary 

22 medicine, and other environmental and natural 

23 resource sciences. 
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1 (4) AGROTERRORISM.—The term 

2 ‘‘agroterrorism’’ means the commission of an 

3 agroterrorist act. 

4 (5) AGROTERRORIST ACT.—The term 

5 ‘‘agroterrorist act’’ means a criminal act consisting 

6 of causing or attempting to cause damage or harm 

7 to, or destruction or contamination of, a crop, live8 stock, farm or ranch equipment, material or prop9 erty associated with agriculture, or a person engaged 

10 in agricultural activity, that is committed with the 

11 intent— 

12 (A) to intimidate or coerce a civilian popu13 lation; or 

14 (B) to influence the policy of a government 

15 by intimidation or coercion. 

16 (6) BIOSECURITY.— 

17 (A) IN GENERAL.—The term ‘‘biosecurity’’ 

18 means protection from the risks posed by bio19 logical, chemical, or radiological agents to— 

20 (i) plant or animal health; 

21 (ii) the agricultural economy; 

22 (iii) the environment; or 

23 (iv) human health. 

24 (B) INCLUSIONS.—The term ‘‘biosecurity’’ 

25 includes the exclusion, eradication, and control 
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1 of biological agents that cause plant or animal 

2 diseases. 

3 (7) COUNTERMEASURE.—The term ‘‘counter4 measure’’ has the meaning given that term in sec5 tion 319F–3 of the Public Health Service Act (as 

6 added by section 202). 

7 (8) INDIAN TRIBE.—The term ‘‘Indian tribe’’ 

8 has the meaning given the term in section 4 of the 

9 Indian Self-Determination and Education Assistance 

10 Act (25 U.S.C. 450b). 

11 (9) SECRETARY.—The term ‘‘Secretary’’ means 

12 the Secretary of Agriculture. 

13 (10) TRIBAL GOVERNMENT.—The term ‘‘tribal 

14 government’’ means the governing body of an Indian 

15 tribe. 

16 SEC. 2703. ESTABLISHMENT OF WORKING GROUP. 

17 The Secretary, in consultation with the Secretary of 

18 Health and Human Services and the Secretary of Home19 land Security, shall establish a working group (referred 

20 to in this title as the ‘‘Working Group’’) that shall include 

21 representatives of— 

22 (1) appropriate agencies of the Department of 

23 Agriculture, appointed by the Secretary; 
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1 (2) the Centers for Disease Control and Preven2 tion, appointed by the Secretary of Health and 

3 Human Services; 

4 (3) the Center for Veterinary Medicine of the 

5 Food and Drug Administration, appointed by the 

6 Secretary of Health and Human Services, in con7 sultation with the Secretary of Defense and the Sec8 retary of Homeland Security; 

9 (4) the Department of Homeland Security, ap10 pointed by the Secretary of Homeland Security; and 

11 (5) the Animal Health Institute. 

12 SEC. 2704. DUTIES. 

13 (a) STUDY.— 

14 (1) IN GENERAL.—The Working Group shall 

15 conduct a study of all matters relating to developing 

16 countermeasures against agroterrorism in the 

17 United States. 

18 (2) MATTERS TO BE STUDIED.—The matters to 

19 be studied by the Working Group shall include— 

20 (A) the nature of United States prepared21 ness for agroterrorism threats to crops and live22 stock in the United States, including an evalua23 tion of the progress of ongoing research, stud24 ies, and programs; 
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1 (B) the availability of countermeasures 

2 against agroterrorism threats; 

3 (C) the strategy used to develop such 

4 qualified countermeasures to both prevent and 

5 control an agroterrorism threat; 

6 (D) the appropriateness of adapting the in7 centives established by the amendments made 

8 by the Project BioShield Act of 2004 (118 Stat. 

9 835) and by this Act (including amendments 

10 made by this Act), to such countermeasures 

11 against agroterrorism; 

12 (E) whether technological innovation is re13 quired to complete the identification, border se14 curity, and transit surveillance of livestock; 

15 (F) the appropriateness of entering into bi16 lateral agreements with countries in which ex17 otic animal disease vaccines that are approved 

18 by the Department of Agriculture are produced 

19 in order to provide for the use of the vaccines 

20 by the United States in the case of an emer21 gency; 

22 (G) the feasibility of producing certain vac23 cines, especially vaccines for foot and mouth 

24 disease, in the continental United States; 
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1 (H) the feasibility of leasing Plum Island, 

2 New York, for use as a commercial vaccine pro3 duction facility; and 

4 (I) the provision of funds for the Agency 

5 for International Development to establish an 

6 office of animal and plant health, the mission of 

7 which is to assist countries in controlling and 

8 eradicating diseases that pose a threat to agri9 culture in the United States. 

10 (b) RECOMMENDATIONS.—The Working Group shall 

11 develop recommendations on— 

12 (1) specific requirements needed to accelerate 

13 the development of countermeasures against 

14 agroterrorism, including research tools, biologics, 

15 and therapeutics; and 

16 (2) if the Working Group determines that the 

17 commercial agricultural industry is incapable or has 

18 inadequate resources to fulfill the biosecurity needs 

19 of the United States, adapting the incentives de20 scribed in subparagraph (D) of subsection (a)(2). 

21 (c) REPORT.—Not later than 1 year after the date 

22 of enactment of this Act, the Working Group shall submit 

23 to the appropriate committees of Congress a report that 

24 contains— 
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1 (1) a detailed statement of the findings and 

2 conclusions of the Working Group; and 

3 (2) the recommendations of the Working Group 

4 for such legislation and administrative actions as the 

5 Working Group considers appropriate. 

6 SEC. 2705. STATE AND LOCAL ASSISTANCE. 

7 (a) STUDY.— 

8 (1) IN GENERAL.—In consultation with the 

9 steering committee of the National Animal Health 

10 Emergency Management System and other stake11 holders, the Secretary shall conduct a study to— 

12 (A) determine the best use of epidemiolo13 gists, animal and plant pathologists, computer 

14 modelers, and statisticians as members of emer15 gency response task forces that handle foreign 

16 or emerging agricultural disease emergencies; 

17 and 

18 (B) identify the types of data that are nec19 essary for proper modeling and analysis of agri20 cultural disease emergencies. 

21 (2) REPORT.—Not later than 180 days after 

22 the date of enactment of this Act, the Secretary 

23 shall submit a report that describes the results of 

24 the study under paragraph (1) to— 
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1 (A) the Secretary of Homeland Security; 

2 and 

3 (B) the head of any other agency involved 

4 in response planning for agricultural disease 

5 emergencies. 

6 (b) GEOGRAPHIC INFORMATION SYSTEM GRANTS.— 

7 (1) IN GENERAL.—The Secretary, in consulta8 tion with the Secretary of Homeland Security and 

9 the Secretary of the Interior, shall establish a pro10 gram under which the Secretary shall provide grants 

11 to States and local governments to develop capabili12 ties to use a geographic information system or sta13 tistical model for an epidemiological assessment in 

14 the event of an agricultural disease emergency. 

15 (2) AUTHORIZATION OF APPROPRIATIONS.— 

16 There are authorized to be appropriated such sums 

17 as may be necessary to carry out this subsection. 

18 (c) GRANTS TO FACILITATE PARTICIPATION OF

19 STATE AND LOCAL ANIMAL AND PLANT HEALTHCARE

20 OFFICIALS.— 

21 (1) IN GENERAL.—The Secretary of Homeland 

22 Security, in coordination with the Secretary, shall 

23 establish a program under which the Secretary of 

24 Homeland Security shall provide grants to commu25 nities to facilitate the participation of State and 
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1 local animal and plant healthcare officials in commu2 nity emergency planning efforts. 

3 (2) AUTHORIZATION OF APPROPRIATIONS.— 

4 There is authorized to be appropriated such sums as 

5 may be necessary to carry out this subsection. 

6 (d) BIOSECURITY AWARENESS AND PROGRAMS.— 

7 (1) IN GENERAL.—The Secretary shall imple8 ment a public awareness campaign for farmers, 

9 ranchers, and other agricultural producers that em10 phasizes— 

11 (A) the need for heightened biosecurity on 

12 farms; and 

13 (B) reporting to the Department of Agri14 culture any agricultural disease anomaly. 

15 (2) ON-FARM BIOSECURITY.— 

16 (A) IN GENERAL.—Not later than 240 

17 days after the date of enactment of this Act, 

18 the Secretary, in consultation with associations 

19 of agricultural producers and taking into con20 sideration research conducted under the Na21 tional Agricultural Research, Extension, and 

22 Teaching Policy Act of 1977 (7 U.S.C. 3101 et 

23 seq.), shall— 

24 (i) develop guidelines— 
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1 (I) to improve monitoring of vehi2 cles and materials entering or leaving 

3 farm or ranch operations; and 

4 (II) to control human traffic en5 tering or leaving farm or ranch oper6 ations; and 

7 (ii) distribute the guidelines developed 

8 under clause (i) to agricultural producers 

9 through agricultural informational semi10 nars and biosecurity training sessions. 

11 (B) AUTHORIZATION OF APPROPRIA12 TIONS.— 

13 (i) IN GENERAL.—There are author14 ized to be appropriated such sums as may 

15 be necessary to carry out this paragraph. 

16 (ii) INFORMATION PROGRAM.—Of the 

17 amounts made available under clause (i), 

18 the Secretary may use such sums as are 

19 necessary to establish in each State an in20 formation program to distribute the bio21 security guidelines developed under sub22 paragraph (A)(i). 

23 (3) BIOSECURITY GRANT PILOT PROGRAM.— 

24 (A) INCENTIVES.— 
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1 (i) IN GENERAL.—Not later than 240 

2 days after the date of enactment of this 

3 Act, the Secretary shall develop a pilot 

4 program to provide incentives, in the form 

5 of grants or low-interest loans, to agricul6 tural producers to restructure farm and 

7 ranch operations (based on the biosecurity 

8 guidelines developed under paragraph 

9 (2)(A)(i)) to achieve the goals described in 

10 clause (ii). 

11 (ii) GOALS.—The goals referred to in 

12 clause (i) are— 

13 (I) to control access to farms and 

14 ranches by persons intending to com15 mit agroterrorist acts; 

16 (II) to prevent the introduction 

17 and spread of agricultural diseases; 

18 and 

19 (III) to take other measures to 

20 ensure biosecurity. 

21 (iii) LIMITATION.—The amount of a 

22 grant or low-interest loan provided under 

23 this paragraph shall not exceed $10,000. 
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1 (B) REPORT.—Not later than 3 years after 

2 the date of enactment of this Act, the Secretary 

3 shall submit to Congress a report that— 

4 (i) describes the implementation of 

5 the pilot program; and 

6 (ii) makes recommendations for ex7 panding the pilot program. 

8 (C) AUTHORIZATION OF APPROPRIA9 TIONS.—There are authorized to be appro10 priated such sums as may be necessary to carry 

11 out this paragraph. 

12 SEC. 2706. INTERAGENCY COORDINATION. 

13 (a) AGRICULTURAL DISEASE LIAISONS.— 

14 (1) AGRICULTURAL DISEASE MANAGEMENT LI15 AISON.—The Secretary of Homeland Security shall 

16 establish a senior level position within the Federal 

17 Emergency Management Agency the primary re18 sponsibility of which is to serve as a liaison for agri19 cultural disease management between— 

20 (A) the Department of Homeland Security; 

21 and 

22 (B)(i) the Federal Emergency Manage23 ment Agency; 

24 (ii) the Department of Agriculture; 
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1 (iii) other Federal agencies responsible for 

2 a response to an emergency relating to an agri3 culture disease; 

4 (iv) the emergency management commu5 nity; 

6 (v) State emergency and agricultural offi7 cials; 

8 (vi) tribal governments; and 

9 (vii) industries affected by agricultural dis10 ease. 

11 (2) ANIMAL HEALTH CARE LIAISON.—The Sec12 retary of Health and Human Services shall establish 

13 within the Department of Health and Human Serv14 ices a senior level position the primary responsibility 

15 of which is to serve as a liaison between— 

16 (A) the Department of Health and Human 

17 Services; and 

18 (B)(i) the Department of Agriculture; 

19 (ii) the animal health community; 

20 (iii) the emergency management commu21 nity; 

22 (iv) tribal governments; and 

23 (v) industries affected by agricultural dis24 ease. 

25 (b) TRANSPORTATION.— 
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1 (1) IN GENERAL.—The Secretary of Transpor2 tation, in consultation with the Secretary and the 

3 Secretary of Homeland Security, shall— 

4 (A) publish in the Federal Register pro5 posed guidelines for restrictions on interstate 

6 transportation of an agricultural commodity or 

7 product in response to an agricultural disease; 

8 (B) provide for a comment period of not 

9 less than 90 days for the proposed guidelines; 

10 and 

11 (C) establish final guidelines, taking into 

12 consideration any comment received under sub13 paragraph (B); and 

14 (2) provide the guidelines described in para15 graph (1) to officers and employees of— 

16 (A) the Department of Agriculture; 

17 (B) the Department of Transportation; 

18 and 

19 (C) the Department of Homeland Security. 

20 SEC. 2707. REGIONAL, STATE, AND LOCAL PREPAREDNESS. 

21 (a) ENVIRONMENTAL PROTECTION AGENCY.—The 

22 Administrator of the Environmental Protection Agency, in 

23 consultation with the Secretary, shall cooperate with re24 gional, State, and local disaster preparedness officials to 

25 include consideration of the potential environmental ef-
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1 fects of a response activity in planning a response to an 

2 agricultural disease. 

3 (b) DEPARTMENT OF AGRICULTURE.—The Sec4 retary, in consultation with the Secretary of Homeland Se5 curity, shall— 

6 (1) develop and implement procedures to pro7 vide information to, and share information among, 

8 Federal, regional, State, tribal, and local officials re9 garding agricultural threats, risks, and 

10 vulnerabilities; and 

11 (2) cooperate with State agricultural officials, 

12 State and local emergency managers, representatives 

13 from State land grant colleges and research univer14 sities, agricultural producers, and agricultural trade 

15 associations to establish local response plans for ag16 ricultural diseases. 

17 (c) FEDERAL EMERGENCY MANAGEMENT AGEN18 CY.—The Director of the Federal Emergency Manage19 ment Agency, in consultation with the Secretary, shall— 

20 (1) establish a task force consisting of agricul21 tural producers and State and local emergency re22 sponse officials to identify the best practices for re23 gional and State agricultural disease programs; 
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1 (2) distribute to States, tribal governments, and 

2 localities a report that describes the best practices 

3 identified under paragraph (1); and 

4 (3) design packages containing exercises for 

5 training, based on the identified best practices, in 

6 the form of printed materials and electronic media, 

7 for distribution to State and local emergency man8 agers, State agricultural officials, and tribal govern9 ment officials. 

10 SEC. 2708. INTERNATIONAL ACTIVITIES. 

11 (a) INTERNATIONAL AGRICULTURAL DISEASE SUR12 VEILLANCE.—Not later than 1 year after the date of en13 actment of this Act, the Secretary, in consultation with 

14 the Secretary of State and the Administrator of the Agen15 cy for International Development, shall submit to Con16 gress a report that describes measures taken by the Sec17 retary to— 

18 (1) streamline the process of notification by the 

19 Secretary to Federal agencies in the event of an ag20 ricultural disease in a foreign country; and 

21 (2) cooperate with representatives of foreign 

22 countries, international organizations, and industry 

23 to develop and implement methods of sharing infor24 mation relating to international agricultural diseases 

25 and unusual agricultural activities. 
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1 (b) INSPECTIONS OF IMPORTED AGRICULTURAL

2 PRODUCTS.—The Secretary of Homeland Security shall— 

3 (1) cooperate with the Secretary and any appro4 priate Federal intelligence official to improve the 

5 ability of the Department of Agriculture to identify 

6 agricultural commodities and products, livestock, 

7 and other goods imported from suspect locations 

8 that are recognized by the intelligence community 

9 as— 

10 (A) having experienced an agricultural ter11 rorist activity or an unusual agricultural dis12 ease; or 

13 (B) harboring or having harbored an 

14 agroterrorist; and 

15 (2) use the information described in paragraph 

16 (1) to establish priorities for inspecting imported ag17 ricultural products. 

18 (c) BILATERAL MUTUAL ASSISTANCE AGREE19 MENTS.—The Secretary of State, in coordination with the 

20 Secretary and the Secretary of Homeland Security, 

21 shall— 

22 (1) enter into mutual assistance agreements 

23 with other countries to provide and receive assist24 ance in the event of an agricultural disease, includ25 ing— 
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1 (A) training for veterinarians and agri2 culture specialists of the United States in the 

3 identification, diagnosis, and control of foreign 

4 agricultural diseases; 

5 (B) providing resources and personnel to a 

6 foreign government with limited resources to re7 spond to an agricultural disease; and 

8 (C) bilateral training programs and exer9 cises relating to assistance provided under this 

10 paragraph; and 

11 (2) provide funding for a program or exercise 

12 described in paragraph (1)(C). 

13 SEC. 2709. REVIEW OF LEGAL AUTHORITY. 

14 (a) IN GENERAL.—The Attorney General, in con15 sultation with the Secretary, shall conduct a review of 

16 State and local laws relating to agroterrorism and biosecu17 rity to determine— 

18 (1) the extent to which the laws facilitate or im19 pede the implementation of a current or proposed re20 sponse plan relating to an agricultural disease; 

21 (2) whether an injunction issued by a State 

22 court could— 

23 (A) delay the implementation of a Federal 

24 response plan described in paragraph (1); or 
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1 (B) affect the extent to which an agricul2 tural disease spreads; and 

3 (3) the types and extent of legal evidence that 

4 may be required by a State court before a response 

5 plan described in paragraph (1) may be imple6 mented. 

7 (b) REPORT.—Not later than 180 days after the date 

8 of enactment of this Act, the Attorney General shall sub9 mit to Congress a report that describes the results of the 

10 review under subsection (a) (including any recommenda11 tions of the Attorney General). 

12 TITLE XXVIII—GLOBAL DIS13 TRIBUTION OF MEDICAL 

14 COUNTERMEASURES 

15 SEC. 2801. FINDINGS. 

16 Congress finds the following: 

17 (1) Experience with infections diseases like HIV 

18 and malaria in developing countries illustrate that 

19 the United States must work with developing coun20 tries to plan for the delivery of products developed 

21 under this Act (and the amendments made by this 

22 Act). 

23 (2) For patients to benefit from these new med24 ical interventions, there must be health care pro-
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1 viders to prescribe and administer such interventions 

2 and assistance to purchase the treatments. 

3 (3) The United States Agency for International 

4 Development (referred to in this title as ‘‘USAID’’) 

5 should work with its counterparts in other highly in6 dustrialized nations to gain assistance in supplying 

7 such products. The Department of Health and 

8 Human Services and USAID should undertake 

9 preapproval planning and multilateral consensus 

10 building to assure optimal outcomes for use of such 

11 products. 

12 SEC. 2802. REPORT BY USAID. 

13 (a) IN GENERAL.—Not later than 1 year after the 

14 date of enactment of this Act, the Administrator of the 

15 United States Agency for International Development (re16 ferred to in this section as the ‘‘Administrator of 

17 USAID’’), in consultation with the entities described 

18 under subsection (b), shall submit to the Committee on 

19 Health, Education, Labor, and Pensions of the Senate and 

20 the Committee on Energy and Commerce of the House 

21 of Representatives the report described under subsection 

22 (c). 

23 (b) CONSULTING ENTITIES.—In preparing the report 

24 under subsection (a), the Administrator of USAID shall 

25 consult with the following entities: 
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1 (1) The Secretary of State. 

2 (2) The United States Global AIDS Coordi3 nator and Office of International Health Affairs. 

4 (3) The Director of the Centers for Disease 

5 Control and Prevention. 

6 (4) The Commissioner of Food and Drugs. 

7 (5) The Surgeon General. 

8 (6) The Secretary of Homeland Security. 

9 (7) The Secretary of Defense. 

10 (8) The Director of the United States Peace 

11 Corps. 

12 (9) The World Health Organization. 

13 (10) The United Nations Children’s Fund 

14 (UNICEF). 

15 (11) The United Nations Human Commissioner 

16 for Refugees (UNHCR). 

17 (12) The Global Fund to fight HIV/AIDS, TB 

18 and Malaria. 

19 (13) The Global Alliance for Vaccines and Im20 munizations (GAVI). 

21 (14) The International Committee of the Red 

22 Cross, the International Federation of Red Cross 

23 and Red Crescent Societies, and the American Red 

24 Cross. 
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1 (15) Other non-profit non-government organiza2 tions and foundations with expertise in the distribu3 tion of infectious disease countermeasures. 

4 (c) REPORT.— 

5 (1) IN GENERAL.—The report under subsection 

6 (a) shall address— 

7 (A) the global distribution of counter8 measures procured under the Project BioShield 

9 Act of 2004 (Public Law 108–276) and this 

10 Act (and the amendments made by such Acts), 

11 particularly countermeasures to infectious dis12 eases that are not terror weapons and that have 

13 a substantial incidence in developing countries; 

14 (B) the existing infrastructure with respect 

15 to ensuring global distribution of such counter16 measures; and 

17 (C) plans for strengthening the infrastruc18 ture described under subparagraph (B) to en19 sure the effective global distribution of such 

20 countermeasures. 

21 (2) CONTENT OF REPORT.—The report under 

22 subsection (a) shall include an analysis with respect 

23 to— 

24 (A) the procedures by which the appro25 priate officials at the Office of Public Health 
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1 Countermeasure Development of the Depart2 ment of Health and Human Services will notify 

3 USAID and other agencies of the types, charac4 teristics, quantity, and timing of the counter5 measures that may become available under the 

6 Project BioShield Act of 2004 (Public Law 

7 108–276) and this Act (and the amendments 

8 made by such Acts); 

9 (B) the types and sources of data upon 

10 which the Government will rely in determining 

11 the numbers and locations of specific popu12 lations that might benefit from such counter13 measures; 

14 (C) the means for ensuring that such 

15 countermeasures will be distributed in devel16 oping countries that cannot purchase the coun17 termeasures; 

18 (D) the trade and regulatory barriers to 

19 the global distribution of such countermeasures 

20 and recommendations for removing such bar21 riers; 

22 (E) the appropriate— 

23 (i) priorities for national and regional 

24 distribution of such countermeasures based 
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1 on public health, medical, and other cri2 teria; 

3 (ii) terms for the transfer and sale of 

4 such countermeasures by the United States 

5 and other entities participating in a pro6 curement pool established under section 

7 319F–3 of the Public Health Service Act 

8 (as added by section 202) to other govern9 ments or nongovernment organizations and 

10 individuals; 

11 (iii) labels and information provided 

12 to public health officials and individuals re13 garding such countermeasures; 

14 (iv) protocols for licensing of counter15 measures distributed globally, and policies 

16 for distribution of unlicensed investiga17 tional countermeasures; 

18 (v) protocols for assessing the safety 

19 and effectiveness of such countermeasures 

20 and any contraindications for the utiliza21 tion of such countermeasures; 

22 (vi) pre- and post-licensing clinical 

23 testing of such countermeasures; 
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1 (vii) strategy for minimizing the devel2 opment of natural resistance to such coun3 termeasures; 

4 (viii) liability and indemnification poli5 cies associated with global distribution of 

6 countermeasures; and 

7 (ix) protections for intellectual prop8 erty associated with such countermeasures; 

9 and 

10 (F) the appropriate protocols for ongoing 

11 assessment of the effectiveness of the global dis12 tribution strategy, including independent as13 sessments. 

14 (d) ASSESSMENT BY THE DIRECTOR OF THE CEN15 TERS FOR DISEASE CONTROL AND PREVENTION.—The 

16 Director of the Centers for Disease Control and Preven17 tion shall submit as part of the report under subsection 

18 (a), an assessment of— 

19 (1) the existing public health infrastructure 

20 available to participate in the global distribution of 

21 the countermeasures described under subsection 

22 (c)(1) and the appropriate strategy for strength23 ening the public health infrastructure necessary for 

24 the global distribution of such countermeasures; 
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1 (2) the capacity of international public health 

2 agencies to respond to a pandemic or other public 

3 health emergency, including distribution of such 

4 countermeasures and other medical countermeasures 

5 and recommendations for strengthening such capac6 ity; 

7 (3) the existing information reporting and diag8 nostic and detection systems regarding global infec9 tious disease and recommendations for strengthening 

10 such systems; 

11 (4) the capacity of international public health 

12 agencies to establish and maintain quarantines or 

13 other isolation strategies to contain outbreaks of in14 fectious diseases and recommendations for strength15 ening such capacity; 

16 (5) the long-term impact on health and chronic 

17 disease of distributing such countermeasures; 

18 (6) the ability of the United States to provide 

19 long-term medical and supportive care for victims of 

20 an infectious disease, or adverse effects of a counter21 measures; 

22 (7) the feasibility of creating a Strategic Global 

23 Stockpile of countermeasures; and 
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1 (8) the feasibility of initiating a global pre2 paredness fund for a global response to outbreaks of 

3 infectious diseases. 

4 TITLE XXIX—ENVIRONMENTAL 

5 PROTECTION AGENCY; DE6 CONTAMINATION AND REME7 DIATION 

8 SEC. 2901. FINDINGS. 

9 Congress finds the following: 

10 (1) Nuclear, biological, and chemical decon11 tamination present different challenges for homeland 

12 security. Nuclear contamination can be detected eas13 ily but can only be remediated by removal of radio14 active material. 

15 (2) Chemical contamination is relatively easy to 

16 detect, dissipates rapidly in warm weather, and inac17 tivates under the right circumstances. 

18 (3) Biological contamination presents the big19 gest challenge, in part, because very large indoor 

20 and outdoor areas may become contaminated (hun21 dreds of square miles) and, in part, because detec22 tion methods and decontamination technologies are 

23 not optimally effective. 

24 (4) Indoor biological decontamination can be 

25 more challenging than outdoor decontamination due 
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1 to the absence of weathering processes and environ2 mental decay. 

3 (5) Current indoor biological decontamination 

4 methods have emerged from ad hoc emergency re5 sponses to the Fall 2001 anthrax letter attacks. 

6 (6) Opening one letter containing several grams 

7 of Bacillus anthracis spores in the Daschle Suite of 

8 the Hart Senate Office Building initiated a 3-month 

9 remediation and restoration effort that ultimately in10 volved 26 Federal buildings at a cost of approxi11 mately $26,000,000. 

12 (7) The transit of several other anthrax-laden 

13 letters through the Brentwood and Trenton United 

14 States Postal Service Processing and Distribution 

Centers led to an unprecedented 3 and 1 15 ⁄2 year re16 mediation effort involving tens of thousands of envi17 ronmental samples and on-site construction of spe18 cialized chlorine dioxide decontamination facilities at 

19 a total cost of more than $200,000,000. 

20 (8) It is not practical to scale up these oper21 ations to handle 1 or more wide-area anthrax re22 leases. 

23 SEC. 2902. REPORT ON CAPABILITIES. 

24 (a) IN GENERAL.—Not later than one year after the 

25 date of enactment of this Act, the Administrator of the 
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1 Environmental Protection Agency (referred to in this sec2 tion as the ‘‘Administrator’’), in consultation with the Sec3 retary of Defense, the Secretary of Health and Human 

4 Services, the Secretary of Homeland Security, and other 

5 Federal agencies as determined appropriated by the Ad6 ministrator, shall submit to the Committees on Health, 

7 Education, Labor, and Pensions, Armed Services, Home8 land Security and Governmental Affairs, and Environment 

9 and Public Works of the Senate and the Committees on 

10 Energy and Commerce, Armed Services, Homeland Secu11 rity, and Resources of the House of Representatives, a re12 port that— 

13 (1) describes— 

14 (A) the state of technology for the detec15 tion and monitoring of nuclear, biological, and 

16 chemical contamination; 

17 (B) the technologies and operational con18 cepts for indoor and outdoor environmental re19 mediation of such contamination; 

20 (C) training and doctrine for decontamina21 tion; 

22 (D) the safety and environmental con23 sequences associated with such remediation and 

24 decontamination procedures; 
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1 (E) the financial costs and timelines asso2 ciated with such procedures; 

3 (F) the number of available decontamina4 tion companies and personnel, along with plans 

5 for augmenting such workforce in an emer6 gency; 

7 (G) the health and safety standards used 

8 to determine efficacy of clean up procedures, 

9 and the state of efforts to define such stand10 ards; 

11 (H) an assessment of Federal assets to co12 ordinate and implement decontamination re13 sponses; and 

14 (I) the ability of the Environmental Pro15 tection Agency and other agencies to train, 

16 equip, and field a dedicated homeland defense 

17 decontamination capability; and 

18 (2) makes recommendations with respect to— 

19 (A) defining different contamination events 

20 and scenarios; 

21 (B) research, technologies, and technology 

22 infrastructure, needed to fill technology defi23 ciencies; 

24 (C) development of doctrine, training, and 

25 certification methods for decontamination; 
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1 (D) methods of enhancing the Federal, as 

2 well as industrial, response capability; 

3 (E) dual use technologies and programs; 

4 (F) methods for coordination among the 

5 Department of Defense, the Department of 

6 Health and Human Services, the Technology 

7 Safety Working Group of the United States 

8 Army, the Defense Advanced Research Projects 

9 Agency, and the Defense Threat Reduction 

10 Agency; 

11 (G) development of standards for decon12 tamination (both health and environmental); 

13 and 

14 (H) a joint decontamination research, de15 velopment, and operational program. 

16 (b) REQUEST BY ADMINISTRATOR.— 

17 (1) IN GENERAL.—The Administrator may re18 quest that the Secretary of Health and Human 

19 Services enter into an interagency agreement, under 

20 terms acceptable to the Secretary, in which the En21 vironmental Protection Agency may order counter22 measures under procurement contracts or procure23 ment pools established by the Secretary. 

24 (2) PROCESSING OF ORDERS.—The ordering of 

25 a countermeasure under an agreement under para-
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1 graph (1) (including transfers of appropriated funds 

2 between the Environmental Protection Agency and 

3 the Department of Health and Human Services to 

4 pay for such order) may be conducted pursuant to 

5 section 1535 of title 31, United States Code, if such 

6 order is processed under the terms established— 

7 (A) by the Secretary of Health and 

8 Human Services in the interagency agreement 

9 described under paragraph (1); and 

10 (B) in the Project BioShield Act of 2004 

11 and this Act (and the amendments made by 

12 such Acts) with respect to the procurement of 

13 countermeasures under sections 319F–1 and 

14 319F–2 of the Public Health Service Act (42 

15 U.S.C. 247d–6a and 247d–6b) (as amended by 

16 this Act). 

Æ