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[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 975 Introduced in Senate (IS)]

  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.

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

SECTION 1. SHORT TITLE.

    (a) Short Title.--This Act may be cited as the ``Project BioShield 
II Act of 2005''.
    (b) In Honor.--This Act is enacted in honor of Robert Stevens, 
Thomas Morris, Jr., Joseph Curseen, Kathy Nguyen, Ottilie Lundgren, and 
Lisa J. Raines, victims of terrorist attacks in the United States in 
2001.
    (c) Table of Contents.--The table of contents of 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.
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.
  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

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

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.

  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.

    (a) In General.--Part B of title III of the Public Health Service 
Act (42 U.S.C. 243 et seq.) is amended--
            (1) in section 319F-1(a)--
                    (A) by redesignating paragraphs (3), (4), and (5) 
                as paragraphs (4), (5), and (6), respectively; and
                    (B) by inserting after paragraph (2) the following:
            ``(3) Inclusion.--The term `qualified countermeasure' 
        includes detection technology, diagnostics, and research tools, 
        as those terms are defined in section 319F-3.''; and
            (2) in section 319F-2(c)(1)(B), in the matter preceding 
        clause (i), by striking ``means a'' and inserting ``means 
        detection technology, diagnostics, and research tools, as those 
        terms are defined in 319F-3, a''.
    (b) Purchase Funds.--Title V of the Homeland Security Act of 2002 
(6 U.S.C. 311 et seq.) is amended by adding at the end the following:

``SEC. 512. COUNTERMEASURE PURCHASE FUND AT THE DEPARTMENT OF HOMELAND 
              SECURITY.

    ``(a) Purchase Fund.--
            ``(1) Establishment of fund.--There is established in the 
        Department a fund to be known as the `Terrorism and Infectious 
        Disease Countermeasure Purchase Fund' (referred to in this 
        subsection as the `Fund') consisting of amounts appropriated 
        for expenditure by the Secretary under paragraph (4). This fund 
        shall be separate from the special reserve fund established 
        under section 510.
            ``(2) Investment of fund.--Amounts in the Fund shall be 
        invested in accordance with section 9702 of title 31, United 
        States Code, and any interest on, and proceeds from, any such 
        investment shall be credited to and become part of the Fund.
            ``(3) Use of fund.--
                    ``(A) In general.--The Secretary shall expend 
                amounts in the Fund--
                            ``(i) for the purchase of countermeasures; 
                        and
                            ``(ii) to provide advance, partial, 
                        progress or other payments, in accordance with 
                        subparagraph (E), to manufacturers of 
                        countermeasures.
                    ``(B) Purchase.--Countermeasures shall be purchased 
                by the Fund at the price and under the terms negotiated 
                by the Secretary and the manufacturer or at a 
                commercial price, if applicable.
                    ``(C) Coordination with the department of health 
                and human services.--The Secretary may delegate 
                authority to the Secretary of Health and Human Services 
                to purchase countermeasures using the Fund. Any such 
                purchases by the Secretary of Health and Human Services 
                shall be conducted as if made by the Secretary under 
                this section.
                    ``(D) Conditions for purchase.--
                            ``(i) In general.--Payments for purchases 
                        under subparagraph (A)(i) shall be made under 
                        such terms and conditions as are set forth in 
                        the contract between the parties.
                            ``(ii) Determinations.--The determinations 
                        required under section 319F-2(c) of the Public 
                        Health Service Act shall not be required with 
                        respect to a contract, grant, or other 
                        transaction funded by the Fund under this 
                        section.
                    ``(E) Advance, partial, progress, or other 
                payments.--
                            ``(i) In general.--The Secretary may make 
                        payments under subparagraph (A)(ii) to 
                        manufacturers of countermeasures prior to the 
                        final purchase of such countermeasure.
                            ``(ii) Basis for payments.--Payments under 
                        this subparagraph shall be based on--
                                    ``(I) the performance of the 
                                manufacturer involved as measured by 
                                the Secretary using objective, 
                                quantifiable methods (such as delivery 
                                of acceptable items, work measurement, 
                                or statistical process controls) 
                                established by the Secretary;
                                    ``(II) the accomplishment of events 
                                or milestones as defined in a program 
                                management plan that is developed by 
                                the manufacturer and submitted to the 
                                Secretary; or
                                    ``(III) other quantifiable measures 
                                of results determined appropriate by 
                                the Secretary.
                            ``(iii) Number, time, and amount of 
                        payments.--
                                    ``(I) In general.--The Secretary 
                                shall, with respect to a manufacturer 
                                of a countermeasure, determine the 
                                number of payments to be made, the 
                                timing of such payments, and subject to 
                                subclause (II), the amount of each such 
                                payment.
                                    ``(II) Limitation.--The amount of a 
                                partial payment made to a manufacturer 
                                under this subparagraph shall not 
                                exceed the portion of the total 
                                purchase price (described in 
                                subparagraph (B)) for the 
                                countermeasure that remains unpaid as 
                                of the date of the payment involved.
                            ``(iv) Conditions for payment.--The 
                        Secretary shall ensure that any payment to 
                        which this subparagraph applies is commensurate 
                        with the actions taken by the manufacturer and 
                        the progress made in achieving the performance 
                        measures under clause (ii)(I) through the time 
                        of such payment. The manufacturer shall provide 
                        such information and evidence as such Secretary 
                        determines necessary to determine compliance 
                        with the preceding sentence.
                            ``(v) Independent research and development 
                        costs.--The payment amount under this 
                        subparagraph may include the costs associated 
                        with independent research and development 
                        undertaken by the manufacturer prior to 
                        entering into a contract or other agreement 
                        with the Secretary under this section.
            ``(4) Authority to contract.--
                    ``(A) In general.--For purposes of a procurement 
                under this subsection, the Secretary shall have 
                responsibilities described in subparagraphs (B) and 
                (C).
                    ``(B) Procurement.--
                            ``(i) In general.--The Secretary shall be 
                        responsible for--
                                    ``(I) arranging for procurement of 
                                a countermeasure, including negotiating 
                                terms (including quantity, production 
                                schedule, and price) of, and entering 
                                into contracts, cooperative agreements, 
                                or other transactions, and for carrying 
                                out such other activities as may 
                                reasonably be required; and
                                    ``(II) promulgating such 
                                regulations as the Secretary determines 
                                necessary to implement the provisions 
                                of this subsection.
                            ``(ii) Other transaction authority, 
                        additional authority for research projects.--
                        The Secretary shall have the authority to enter 
                        into transactions (other than procurement 
                        contracts, grants, and cooperative agreements), 
                        including transactions for prototypes, to the 
                        same extent as provided to the Secretary of 
                        Defense under section 2371 of title 10, United 
                        States Code, for purposes of carrying out the 
                        objectives of the Project BioShield II Act of 
                        2005.
                            ``(iii) Contract terms.--
                                    ``(I) Mandatory terms.--A contract 
                                for procurement under this subsection 
                                shall include the following terms:
                                            ``(aa) Contract duration.--
                                        The contract shall be for a 
                                        period not to exceed 10 years, 
                                        except that, in first awarding 
                                        the contract, the Secretary may 
                                        provide for a longer duration, 
                                        not exceeding a total of 18 
                                        years, if the Secretary 
                                        determines that complexities or 
                                        other difficulties in 
                                        performance under the contract 
                                        justify such an extended 
                                        period. The contract shall be 
                                        renewable for additional 
                                        periods, none of which shall 
                                        exceed 5 years.
                                            ``(bb) Product approval.--
                                        The contract shall provide that 
                                        the vendor seek approval, 
                                        clearance, or licensing or 
                                        validating of the product from 
                                        the Secretary or other 
                                        appropriate Federal agency and 
                                        for a timetable for the 
                                        development of data and other 
                                        information to support such 
                                        approval, clearance, or 
                                        licensing, and that the 
                                        Secretary may waive part or all 
                                        of such contract term on 
                                        request of the vendor or on the 
                                        initiative of the Secretary.
                                    ``(II) Storage by vendor.--A 
                                contract for procurement under this 
                                subsection may provide that the vendor 
                                provide storage for stocks of a product 
                                delivered to the ownership of the 
                                Federal Government under the contract, 
                                for such period and under such terms 
                                and conditions as the Secretary may 
                                specify, and in such case amounts from 
                                the purchase fund under subsection (a) 
                                shall be available for costs of 
                                shipping, handling, storage, and 
                                related costs for such product.
                                    ``(III) Warm industrial base fee.--
                                A contract for procurement under this 
                                section may provide that the vendor 
                                receive a fee for establishing and 
                                maintaining manufacturing capacity in 
                                excess of the initial requirement of 
                                purchase of the countermeasure, in 
                                order to ensure that the Secretary has 
                                available a warm industrial base in the 
                                event of the need to increase purchases 
                                of countermeasures. To the extent 
                                practicable, the Secretary shall modify 
                                contracts in existence on the date of 
                                enactment of this Act to have available 
                                a warm industrial base. The cost of 
                                maintaining a warm industrial base 
                                shall be an allowable and allocable 
                                direct cost to the contract.
                                    ``(IV) Purchase of fda licensed 
                                products.--Nothing in this section 
                                shall be construed to prevent the 
                                Secretary from purchasing 
                                countermeasures that are licensed by 
                                the Food and Drug Administration for 
                                the indicated use or, in the event of a 
                                countermeasure that is established to 
                                be safe and effective for uses other 
                                than those indicated on the label of 
                                such countermeasure, a use for which 
                                the vendor may be approved under 
                                emergency use authorities or approval 
                                by the Food and Drug Administration 
                                subsequent to purchase.
                                    ``(V) Other contract 
                                requirements.--
                                            ``(aa) Cost accounting 
                                        standard.--Notwithstanding any 
                                        other provision of law, the 
                                        cost accounting standards set 
                                        forth under chapter 99 of title 
                                        48, Code of Federal 
                                        Regulations, the cost 
                                        principles set forth under part 
                                        31 of title 48, Code of Federal 
                                        Regulations, and the 
                                        requirement for submission of 
                                        certified cost and pricing data 
                                        under section 304A of the 
                                        Federal Property and 
                                        Administrative Services Act of 
                                        1949 (41 U.S.C. 254b) shall not 
                                        apply to any contract, grant, 
                                        or cooperative agreement 
                                        entered into under the Project 
                                        BioShield Act of 2004 (or the 
                                        amendments made to such Act by 
                                        the Project BioShield II Act of 
                                        2005.).
                                            ``(bb) Single 
                                        transaction.--The Secretary 
                                        shall, to the extent 
                                        practicable, enter into a 
                                        single transaction with each 
                                        contractor for the procurement 
                                        of countermeasures, even if 
                                        additional research and 
                                        development of such 
                                        countermeasures may be 
                                        required, so long as the 
                                        Secretary determines that 
                                        sufficient and satisfactory 
                                        clinical experience or research 
                                        data supports a reasonable 
                                        conclusion that such security 
                                        countermeasures will qualify 
                                        for approval or licensing by 
                                        the Food and Drug 
                                        Administration within 8 years 
                                        from the date of entering into 
                                        the procurement transaction.
                            ``(iv) Procurement of multiple product and 
                        technologies.--Notwithstanding any other 
                        provision of law, the Secretary shall, to the 
                        maximum extent practicable, enter into multiple 
                        transactions for the procurement of multiple 
                        technologies and products from multiple 
                        manufacturers of countermeasures in order to 
                        mitigate the risks associated with dependence 
                        on a single supplier or technology.
                            ``(v) Single transaction.--The Secretary 
                        shall, to the extent practicable, enter into a 
                        single transaction for the procurement of 
                        countermeasures, even if additional research 
                        and development of such countermeasures may be 
                        required, so long as the Secretary determines 
                        that sufficient and satisfactory clinical 
                        experience or research data supports a 
                        reasonable conclusion that such security 
                        countermeasures will qualify for approval or 
                        licensing by the Food and Drug Administration 
                        within 8 years from the date of entering into 
                        the procurement transaction. The fact that an 
                        entity has not filed for investigational new 
                        drug status with the Food and Drug 
                        Administration, or has filed for such status 
                        but has not yet been approved, shall not be the 
                        sole basis for a determination by the Secretary 
                        with respect to whether a countermeasure 
                        qualifies for approval or licensing by the Food 
                        and Drug Administration not more than 8 years 
                        from the date of the procurement transaction.
                            ``(vi) Availability of simplified 
                        acquisition procedures.--
                                    ``(I) In general.--If the Secretary 
                                determines that there is a pressing 
                                need for a procurement of a specific 
                                countermeasure, the amount of the 
                                procurement under this subsection shall 
                                be deemed to be below the threshold 
                                amount specified in section 4(11) of 
                                the Office of Federal Procurement 
                                Policy Act (41 U.S.C. 403(11)), for 
                                purposes of application to such 
                                procurement, pursuant to section 
                                302A(a) of the Federal Property and 
                                Administrative Services Act of 1949 (41 
                                U.S.C. 252a(a)), of--
                                            ``(aa) section 303(g)(1)(A) 
                                        of the Federal Property and 
                                        Administrative Services Act of 
                                        1949 (41 U.S.C. 253(g)(1)(A)) 
                                        and its implementing 
                                        regulations; and
                                            ``(bb) section 302A(b) of 
                                        such Act (41 U.S.C. 252a(b)) 
                                        and its implementing 
                                        regulations.
                                    ``(II) Application of certain 
                                provisions.--Notwithstanding subclause 
                                (I) and the provisions of law and 
                                regulations referred to in such clause, 
                                each of the following provisions shall 
                                apply to procurements described in this 
                                clause to the same extent that such 
                                provisions would apply to such 
                                procurements in the absence of 
                                subclause (I):
                                            ``(aa) Chapter 37 of title 
                                        40, United States Code 
                                        (relating to contract work 
                                        hours and safety standards).
                                            ``(bb) Subsections (a) and 
                                        (b) of section 7 of the Anti-
                                        Kickback Act of 1986 (41 U.S.C. 
                                        57 (a) and (b)).
                                            ``(cc) Section 304C of the 
                                        Federal Property and 
                                        Administrative Services Act of 
                                        1949 (41 U.S.C. 254d) (relating 
                                        to the examination of 
                                        contractor records).
                                            ``(dd) Section 3131 of 
                                        title 40, United States Code 
                                        (relating to bonds of 
                                        contractors of public buildings 
                                        or works).
                                            ``(ee) Subsection (a) of 
                                        section 304 of the Federal 
                                        Property and Administrative 
                                        Services Act of 1949 (41 U.S.C. 
                                        254(a)) (relating to contingent 
                                        fees to middlemen).
                                            ``(ff) Section 6002 of the 
                                        Solid Waste Disposal Act (42 
                                        U.S.C. 6962).
                                            ``(gg) Section 1354 of 
                                        title 31, United States Code 
                                        (relating to the limitation on 
                                        the use of appropriated funds 
                                        for contracts with entities not 
                                        meeting veterans employment 
                                        reporting requirements).
                                    ``(III) Internal controls to be 
                                established.--The Secretary shall 
                                establish appropriate internal controls 
                                for procurements made under this 
                                clause, including requirements with 
                                respect to documentation of the 
                                justification for the use of the 
                                authority provided under this paragraph 
                                with respect to the procurement 
                                involved.
                                    ``(IV) Authority to limit 
                                competition.--In conducting a 
                                procurement under this subparagraph, 
                                the Secretary may not use the authority 
                                provided for under subclause (I) to 
                                conduct a procurement on a basis other 
                                than full and open competition unless 
                                the Secretary determines that the 
                                mission of the BioShield Program under 
                                the Project BioShield II Act of 2005 
                                would be seriously impaired without 
                                such a limitation.
                            ``(vii) Procedures other than full and open 
                        competition.--
                                    ``(I) In general.--In using the 
                                authority provided in section 303(c)(1) 
                                of the Federal Property and 
                                Administrative Services Act of 1949 (41 
                                U.S.C. 253(c)(1)) to use procedures 
                                other than competitive procedures in 
                                the case of a procurement under this 
                                subsection, the phrase `available from 
                                only one responsible source' in such 
                                section 303(c)(1) shall be deemed to 
                                mean `available from only one 
                                responsible source or only from a 
                                limited number of responsible sources'.
                                    ``(II) Relation to other 
                                authorities.--The authority under 
                                subclause (I) is in addition to any 
                                other authority to use procedures other 
                                than competitive procedures.
                                    ``(III) Applicable government wide 
                                regulations.--The Secretary shall 
                                implement this clause in accordance 
                                with regulations implementing such 
                                section 303(c)(1) (including 
                                requirements that offers be solicited 
                                from as many potential sources as is 
                                practicable under the circumstances, 
                                that required notices be published, and 
                                that submitted offers be considered), 
                                as such regulations apply to 
                                procurements for which an agency has 
                                authority to use procedures other than 
                                competitive procedures when the 
                                property or services needed by the 
                                agency are available from only one 
                                responsible source or only from a 
                                limited number of responsible sources 
                                and no other type of property or 
                                services will satisfy the needs of the 
                                agency.
                            ``(viii) Premium provision in multiple 
                        award contracts.--
                                    ``(I) In general.--If, under this 
                                subsection, the Secretary enters into 
                                contracts with more than one vendor to 
                                procure a countermeasure, such 
                                Secretary may, notwithstanding any 
                                other provision of law, include in each 
                                of such contracts a provision that 
                                identifies an increment of the total 
                                quantity of countermeasure required, 
                                whether by percentage or by numbers of 
                                units.
                                    ``(II) Determination of 
                                government's requirement not 
                                reviewable.--If the Secretary includes 
                                in each of a set of contracts a 
                                provision as described in subclause 
                                (I), such Secretary's determination of 
                                the total quantity of countermeasures 
                                required, and any amendment of such 
                                determination, is committed to agency 
                                discretion.
                            ``(ix) Extension of closing date; receipt 
                        of proposals not reviewable.--A decision by the 
                        Secretary to extend the closing date for 
                        receipt of proposals for a procurement under 
                        this subsection is committed to agency 
                        discretion.
                            ``(x) Limiting competition to sources 
                        responding to request for information.--In 
                        conducting a procurement under this subsection, 
                        the Secretary may exclude a source that has not 
                        responded to a request for information under 
                        section 303A(a)(l)(B) of the Federal Property 
                        and Administrative Services Act of 1949 (41 
                        U.S.C. 253a(a)(1)(B)) if such request has given 
                        notice that the Secretary may so exclude such a 
                        source.
                    ``(C) Countermeasures purchased.--Any stockpiles of 
                countermeasures purchased under this section may be 
                held in the strategic national stockpile under section 
                319F-2 of the Public Health Service Act (42 U.S.C. 
                247d-6b).
            ``(5) Requirements for manufacturers.--The Secretary, or 
        the Secretary of Health and Human Services under delegated 
        authority, shall provide to manufacturers to the extent 
        feasible the logistical and operational requirements of 
        countermeasures prior to their development and acquisition. The 
        logistical and operational requirements will consider public 
        health needs as well as requirements for storage, maintenance, 
        security, rotation, and transport of any countermeasures 
        purchased through the Countermeasure Purchase Fund.
            ``(6) Coordination.--Consistent with the provisions of 
        section 319F-2(c)(2)(B) of the Public Health Service Act, the 
        Secretary shall coordinate with the Secretary of Health and 
        Human Services to store, maintain, secure, rotate, and 
        transport any materiel purchased through the Countermeasure 
        Purchase Fund and designated for use in the Strategic National 
        Stockpile under such section 319F-2.
            ``(7) Appropriation.--
                    ``(A) In general.--The total appropriations made 
                available for both the Fund under section 512 and the 
                special reserve fund under section 510 may be used to 
                provide funding for activities conducted by the 
                Secretary and, where appropriate, the Secretary of 
                Health and Human Services, in accordance with the 
                Project BioShield Act of 2004 and the Project BioShield 
                II Act of 2005 (and the amendments made by such Acts).
                    ``(B) Use of funds.--The Secretary, or the 
                Secretary of Health and Human Services under delegated 
                authority, may use the funds under this section to 
                cover the costs of storage, maintenance, security, 
                rotation, and transport of any material purchased 
                through the Countermeasure Purchase Fund.''.
    ``(b) Definition.--In this section, the term `countermeasure' has 
the meaning given such term in section 319F-3 of the Public Health 
Service Act.''.

SEC. 102. ADDITIONAL AUTHORITY UNDER PROJECT BIOSHIELD.

    (a) Additional Authority for Research Projects.--Section 319F-1 of 
the Public Health Service Act (42 U.S.C. 247d-6a) is amended by--
            (1) redesignating subsection (f) as subsection (g); and
            (2) inserting after subsection (e) the following:
    ``(f) Other Transaction Authority.--The Secretary shall have the 
authority to enter into transactions (other than procurement contracts, 
grants, and cooperative agreements), including transactions for 
prototypes, to the same extent as provided to the Secretary of Defense 
under section 2371 of title 10, United States Code, for purposes of 
carrying out the objectives of the Project BioShield Act of 2004.''.
    (b) Encouragement of Technology Transfer and Commercialization.--
Section 319F-2(c)(5)(B)(iii) of the Public Health Service Act (42 
U.S.C. 247d-6b(c)(5)(B)(iii)) is amended to read as follows:
                            ``(iii) Where there is a potential to 
                        transfer the technology developed as a security 
                        countermeasure to the commercial market, either 
                        as a countermeasure to be sold in foreign 
                        markets or, if the countermeasure has 
                        beneficial use and utility for indications 
                        other than chemical, biological, radiological, 
                        or nuclear protection, for use as other than a 
                        countermeasure in commercial markets thus 
                        meriting Federal funding to stimulate and 
                        encourage such commercialization and technology 
                        transfer, and demonstrating a potential return 
                        on such Federal investment.''.
    (c) Procurement of Certain Countermeasures.--Section 319F-2 of the 
Public Health Service Act (42 U.S.C. 247d-6b) is amended by--
            (1) redesignating subsections (e) and (f) as subsections 
        (l) and (m), respectively; and
            (2) by inserting after subsection (d) the following:
    ``(e) Procurement of Certain Countermeasures.--
            ``(1) In general.--The Secretary shall, to the extent 
        practicable, enter into transactions for the procurement of 
        security countermeasures, even if additional research and 
        development of such security countermeasures may be required, 
        so long as the Secretary determines that sufficient and 
        satisfactory clinical experience or research data supports a 
        reasonable conclusion that such security countermeasures will 
        qualify for approval or licensing by the Food and Drug 
        Administration within 8 years from the date of entering into 
        the procurement transaction.
            ``(2) Basis for determination.--The fact that an entity has 
        not filed for Investigational New Drug status with the Food and 
        Drug Administration, or has filed for such status but has not 
        yet been approved, shall not be the sole basis for a 
        determination by the Secretary with respect to whether a 
        security countermeasure qualifies for approval or licensing by 
        the Food and Drug Administration within 8 years from the date 
        of entering into the procurement transaction.
    ``(f) Effect of Section.--Notwithstanding any other provision of 
law, the cost accounting standards set forth under chapter 99 of title 
48, Code of Federal Regulations, the cost principles set forth under 
part 31 of title 48, Code of Federal Regulations, and the requirement 
of the submission of certified cost and pricing information under 
section 254b of title 41, United States Code, shall not apply to any 
contract, grant, or cooperative agreement entered into under the 
Project BioShield Act of 2004 (or the amendments made to such Act by 
the Project BioShield II Act of 2005).
    ``(g) Accelerated Approval.--An entity that enters into an 
agreement under this section, section 319F-1, or section 512 of the 
Homeland Security Act of 2002 shall be eligible for accelerated 
approval of a countermeasure in accordance with section 573 of the 
Federal Food, Drug, and Cosmetic Act.
    ``(h) Procurement of Multiple Product and Technologies.--
Notwithstanding any other provision of law, the Secretary shall, to the 
extent practicable, enter into multiple transactions for the 
procurement of multiple technologies and products from multiple 
manufacturers of qualified and security countermeasures (as defined by 
this section and section 319F-1) in order to mitigate the risks 
associated with dependence on a single supplier or technology.
    ``(i) Warm Industrial Base Fee.--A contract for procurement under 
this section may provide that the vendor receive a fee for establishing 
and maintaining manufacturing capacity in excess of the initial 
requirement of purchase of the countermeasure, in order to ensure that 
the Secretary has available a warm industrial base in the event of the 
need to increase purchases of countermeasures. To the extent 
practicable, the Secretary shall modify contracts in existence on the 
date of enactment of this subsection to have available a warm 
industrial base. The Secretary shall deem the cost of such fee 
allowable and allocable as a direct cost to the contract.
    ``(j) Purchase of FDA Licensed Products.--Nothing in this section 
shall be construed to prevent the Secretary from purchasing 
countermeasures that are licensed by the Food and Drug Administration 
for the indicated use or, in the event of a countermeasure that is 
established to be safe and effective for uses other than those 
indicated on the label of such countermeasure, a use for which the 
vendor may be approved under emergency use authorities or approval by 
the Food and Drug Administration subsequent to purchase.''.
    (d) Technical Amendments.--Section 319F-2 of the Public Health 
Service Act (42 U.S.C. 247d-6b) is amended by--
            (1) in the section heading, inserting ``and Security 
        Countermeasure Procurements'' after ``Stockpile''; and
            (2) in subsection (c)--
                    (A) in the heading, by deleting ``biomedical'';
                    (B) in paragraph (5)--
                            (i) by amending subparagraph (A) to read as 
                        follows:
                    ``(A) In general.--The Secretary, in accordance 
                with the provisions of this paragraph, shall identify 
                specific security countermeasures that the Secretary 
                determines, in consultation with the Homeland Security 
                Secretary, to be appropriate for inclusion in the 
                stockpile under subsection (a) or acquisition for other 
                purposes pursuant to procurements made with amounts in 
                the special reserve fund under paragraph (10) (referred 
                to in this subsection individually as a ``procurement 
                under this subsection'').''; and
                            (ii) in subparagraph (B)(ii), by deleting 
                        the word ``stockpile'' and inserting 
                        ``government'';
                    (C) by amending paragraph (6)(D) to read as 
                follows:
                    ``(D) Subsequent specific countermeasures.--
                Procurement under this subsection of a security 
                countermeasure for a particular purpose does not 
                preclude the subsequent procurement under this 
                subsection of any other security countermeasure for 
                such purpose if the Secretary has determined under 
                paragraph (5)(A) that such countermeasure is 
                appropriate for inclusion in the stockpile or 
                acquisition for other purposes and if, as determined by 
                the Secretary, such countermeasure provides improved 
                safety or effectiveness, or for other reasons enhances 
                preparedness to respond to threats of use of a 
                biological, chemical, radiological, or nuclear agent. 
                Such a determination by the Secretary is committed to 
                agency discretion.''; and
                    (D) in paragraph (8)--
                            (i) in subparagraph (A)--
                                    (I) by striking ``Cooperation.--'' 
                                and all that follows through ``out'' 
                                and inserting ``Cooperation.--In 
                                carrying out''; and
                                    (II) by striking ``, subject to 
                                subparagraph (B),''; and
                            (ii) by striking subparagraph (B).

SEC. 103. REQUEST OF AGENCY.

    Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) 
(as amended by section 102) is further amended by inserting after 
subsection (j) the following:
    ``(k) Request of Agency To Use BioShield I and BioShield II 
Authority and Incentives.--
            ``(1) In general.--Upon request by a Federal agency, the 
        Secretary may establish interagency agreements, under terms 
        acceptable to the Secretary, in which such agency may order 
        countermeasures under procurement contracts or procurement 
        pools established by the Secretary.
            ``(2) Processing of orders.--The ordering of a 
        countermeasure under an agreement under paragraph (1) 
        (including transfers of appropriated funds between an agency 
        and the Department to pay for such orders) may be conducted 
        pursuant to section 1535 of title 31, United States Code, if 
        such order is processed under the terms established--
                    ``(A)(1) in the interagency agreement required by 
                subsection (c)(7)(B), for orders of detection 
                technology and decontamination technology placed by the 
                Department of Homeland Security; or
                    ``(2) by the Secretary in the interagency agreement 
                described under paragraph (1) for all other orders; and
                    ``(B) in the Project BioShield Act of 2004 and the 
                Project BioShield II Act of 2005 (and the amendments 
                made by such Acts) with respect to the procurement of 
                countermeasures under this section and section 319F-
                1.''.

  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.

    (a) Countermeasures To Detect, Diagnose, Prevent, or Treat an 
Infectious Disease.--
            (1) Procurement authority.--Section 319F-1(a)(2) of the 
        Public Health Service Act (42 U.S.C. 247d-6a) is amended--
                    (A) in subparagraph (A), by striking ``; or'' and 
                inserting a semicolon;
                    (B) in subparagraph (B), by striking the period and 
                inserting ``; or''; and
                    (C) by adding after subparagraph (B) the following:
                    ``(C) detect, diagnose, treat, or prevent an 
                infectious disease (as defined in section 319F-3(a)(6)) 
                adversely affecting public health.''.
            (2) Strategic national stockpile.--Section 319F-2(c)(1)(B) 
        of the Public Health Service Act is amended--
                    (A) in clause (i)(III)(bb), by striking ``; or'' 
                and inserting a semicolon;
                    (B) in clause (ii), by striking the period and 
                inserting ``; or''; and
                    (C) by adding at the end the following:
                            ``(iii) is intended to detect, diagnose, 
                        prevent, or treat an infectious disease (as 
                        defined in section 319-3(a)(6)).''.

SEC. 202. PROCUREMENT POOLS; ADDITIONAL INCENTIVES UNDER PROJECT 
              BIOSHIELD.

    (a) In General.--Part B of title III of the Public Health Service 
Act (42 U.S.C. 243 et seq.), as amended by section 101, is amended by 
inserting after section 319F-2 the following:

``SEC. 319F-3. PROCUREMENT OF CERTAIN DRUGS, DETECTION TECHNOLOGY, 
              DIAGNOSTICS, AND RESEARCH TOOLS.

    ``(a) Definitions.--For purposes of this part:
            ``(1) Biological or chemical agent; toxin; nuclear or 
        radiological material; terror weapon.--The term--
                    ``(A) `biological agent', `biological toxin', or 
                `chemical agent', or any variation of any such term, 
                includes any microorganism, virus, infectious 
                substance, toxic biological product, or toxic or 
                poisonous chemical, that may be used in a manner that 
                may cause widespread death or serious bodily injury, 
                including biological agents and toxins described in 
                paragraphs (1) and (2) of section 178 of title 18, 
                United States Code;
                    ``(B) `nuclear or radiological material' means any 
                radioactive material that may be used in a manner that 
                may cause widespread death or serious bodily injury; 
                and
                    ``(C) `terror weapon' or `weapon of mass 
                destruction' mean any matter described in subparagraph 
                (A) or (B) that may be used in a manner that may cause 
                widespread death or serious bodily injury.
            ``(2) Countermeasure.--The term `countermeasure' means--
                    ``(A) a vaccine and related delivery system, anti-
                infective, antibiotic or combinations thereof, therapy, 
                microbicide, diagnostic technology, drug, biological 
                product, chemical, or other technology that is subject 
                to applicable provisions of this Act, the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or the 
                Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.), and that 
                prevents infection with, or the spread of, or the 
                directly diagnose, treat, or prevent the pathological 
                effects of infection with, bodily harm from, or the 
                spread of, a biological or chemical agent or toxin on 
                the list described in subsection (f), including 
                treatments for addressing excessive bleeding and other 
                trauma following a terrorist attack;
                    ``(B) a therapy, diagnostic, or piece of equipment 
                that may be used to detect, treat, or prevent bodily 
                harm that may be caused by the use of biological, 
                chemical, nuclear, or radiological material as a terror 
                weapon or by an infectious disease;
                    ``(C) a qualified countermeasure, as defined in 
                section 319F-1; or
                    ``(D) a security countermeasure, as defined in 
                section 319F-2.
            ``(3) Decontamination technology.--The term 
        `decontamination technology' means a product or service used 
        for the decontamination of property following a terrorist 
        attack.
            ``(4) Detection Technology.--The term `detection 
        technology' means scientific instruments, consumables (such as 
        reagents or assays, including reagents or assays using 
        polymerase chain reaction (PCR) or Real Time PCR), software, or 
        services for the detection of the presence, concentration, 
        characteristics, or identification of a biological, chemical, 
        nuclear, radiological agent, or infectious disease in 
        environmental or field samples.
            ``(5) Development.--The term `development' or `to develop' 
        includes research leading to the identification and isolation 
        of suitable compounds or biological materials, the engineering, 
        modification (including research leading to the expanded use of 
        currently approved drugs or biological products), evaluation, 
        production, and formulation of such compounds or materials, the 
        conduct of preclinical and clinical studies, the preparation of 
        an application for marketing approval, and preparation of test 
        methods, with respect to countermeasures regulated by the Food 
        and Drug Administration, and other actions prior to approval of 
        a countermeasure by the Food and Drug Administration or when it 
        is procured as an unlicensed countermeasure under section 319F-
        2(e).
            ``(6) Diagnostics.--
                    ``(A) In general.--The term `diagnostics' includes 
                products, devices, and technologies to detect, 
                identify, or analyze the potential presence of, or 
                exposure to, 1 or more biological, nuclear, 
                radiological, or chemical agent or toxin in potentially 
                exposed individuals through means to enable effective 
                medical intervention through the administration of 
                appropriate countermeasures.
                    ``(B) Inclusion.--The term `diagnostics' includes 
                technologies that diagnose or screen for the health and 
                safety of potentially exposed individuals and products 
                that serve as contraindicators for vaccines or drugs.
            ``(7) Infectious disease.--
                    ``(A) In general.--The term `infectious disease' 
                means a disease in humans caused by--
                            ``(i) a microbe (including a bacteria, 
                        virus, fungus, or parasite) that is acquired by 
                        a person and that reproduces in that person;
                            ``(ii) microbial products (such as 
                        botulinum toxin); or
                            ``(iii) a prion.
                    ``(B) Inclusion.--The term `infectious disease' 
                includes--
                            ``(i) a disease in humans caused by a 
                        microorganism, whether or not--
                                    ``(I) such microorganism is 
                                acquired by an individual through 
                                human-to-human contact; or
                                    ``(II) if the individual is 
                                initially symptomatic of the disease; 
                                and
                            ``(ii) zoonotic diseases that may find 
                        hosts in animal and human populations.
            ``(8) Manufacturer.--
                    ``(A) In general.--The term `manufacturer' means an 
                entity responsible for research, evaluation, 
                development, or production of a countermeasure and, 
                except for a countermeasure that is not subject to 
                review and approval by the Food and Drug Administration 
                prior to marketing (such as research tools), the 
                potential or actual holder of the approved new drug 
                application, biologic license application, or product 
                license application or equivalent for such 
                countermeasure.
                    ``(B) Limitation.--The term `manufacturer' does not 
                require that a manufacturer conduct the actual 
                research, evaluation, development, or production in its 
                own facilities, but may enter into arrangements with 
                third parties for the research, evaluation, 
                development, or production of the countermeasure.
            ``(9) Research tool.--The term `research tool' includes the 
        full range of tools and systems that accelerate the discovery, 
        development, and manufacture of countermeasures, including 
        animal disease models, cell lines, cell line cultures for the 
        production of biologics, de novo DNA synthesis, monoclonal and 
        polyclonal antibodies, reagents or assays (such as those 
        utilizing the polymerase chain reaction (PCR) or Real Time PCR 
        processes), drug delivery technologies, vaccine adjuvants, 
        antibiotic sensitivity screens, laboratory animals, large 
        animals including nonhuman primates (and other such animals 
        used or intended to be used for drug production), growth 
        factors, combinatorial chemistry and DNA libraries, vaccine 
        antigen libraries, clones and cloning tools (such as PCR or 
        Real Time PCR), methods, laboratory equipment and machines, 
        databases, and other technologies that enable the rapid and 
        effective development of countermeasures, including 
        diagnostics, vaccines, drugs, antibiotics, non-laboratory 
        tools, and tools systems that directly assist such 
        countermeasure development efforts.
    ``(b) Procurement Pools.--
            ``(1) In general.--Notwithstanding any other provision of 
        law, the Secretary shall establish, and make payments from, 
        procurement pools with respect to the procurement of a 
        qualified countermeasure under section 319F-1 or a security 
        countermeasure under section 319F-2.
            ``(2) Role of other organizations.--In organizing the 
        procurement pools under paragraph (1), the Secretary may accept 
        contributions and guarantees from--
                    ``(A) non-governmental organizations;
                    ``(B) international health agencies;
                    ``(C) the United Nations;
                    ``(D) the Global Vaccine Acquisition Initiative; 
                and
                    ``(E) private nonprofit organizations that are 
                organized to support international public health 
                research and programs.
            ``(3) Consultation.--The Secretary shall--
                    ``(A) consult with the organizations described 
                under paragraph (2) regarding the terms and management 
                of procurement contracts that exceed $25,000,000 in 
                value under this section and sections 319F-1 and 319F-2 
                that receive payment from the procurement pool 
                established under paragraph (1); and
                    ``(B) provide information to such organizations 
                regarding such procurement contracts.
            ``(4) Limitation.--Nothing in this part shall be construed 
        to prohibit the Secretary or the Secretary of Homeland Security 
        (with respect to procurement agreements under section 512 of 
        the Homeland Security Act of 2002) from accepting contributions 
        and guarantees from organizations that receive funding from the 
        Federal Government.
            ``(5) Contribution to other pools.--The Secretary and the 
        Secretary of Homeland Security (with respect to procurement 
        agreements under section 512 of the Homeland Security Act of 
        2002) may contribute funds to procurement pools organized by 
        other entities, such as foreign governments, the United 
        Nations, or nonprofit or non-governmental entities for 
        procurement of qualified and security countermeasures.
    ``(c) Advisory Committee.--
            ``(1) Establishment.--The Secretary shall establish an 
        advisory committee to be known as the International Public 
        Health Advisory Committee (referred to in this section as the 
        `Advisory Committee').
            ``(2) Membership.--
                    ``(A) In general.--The Advisory Committee shall be 
                composed of representatives, to be appointed by the 
                Secretary, from organizations, including the Centers 
                for Disease Control and Prevention and the 
                organizations described in subparagraph (B), with 
                expertise and resources regarding the development and 
                distribution of countermeasures against biological, 
                chemical, nuclear, or radiological agents or infectious 
                diseases.
                    ``(B) Organizations described.--The organizations 
                described under this subparagraph are--
                            ``(i) non-governmental organizations;
                            ``(ii) international health agencies;
                            ``(iii) the United Nations;
                            ``(iv) the Global Vaccine Acquisition 
                        Initiative; and
                            ``(v) private nonprofit organizations that 
                        are organized to support international public 
                        health research and programs.
            ``(3) Duties of advisory committee.--The Advisory 
        Committee, through a public process, shall--
                    ``(A) develop an international, multifaceted, and 
                coordinated strategy, that, with respect to 
                countermeasures against biological, chemical, 
                radiological, and nuclear agents or infectious 
                disease--
                            ``(i) develops strategies for establishing 
                        procurement pools;
                            ``(ii) develops strategies to facilitate 
                        partnerships between the government and private 
                        sector;
                            ``(iii) makes recommendations for 
                        strengthening the infrastructure necessary for 
                        researching, creating, and stockpiling critical 
                        therapeutics;
                            ``(iv) recommends ways in which the 
                        countermeasure development process may be 
                        shortened; and
                            ``(v) makes recommendations for priority 
                        areas for developing research and discovery 
                        programs necessary to develop countermeasures;
                    ``(B) develop criteria for determining which 
                countermeasures against biological, chemical, nuclear, 
                and radiological agents or infectious disease should be 
                developed and procured;
                    ``(C) explore priority broad spectrum therapeutics 
                and ways in which the countermeasure development 
                process may be accelerated to facilitate rapid 
                development of new drugs in the event of an attack with 
                a previously unknown biological agent or pathogen; and
                    ``(D) recognize the importance and the need for 
                advancement in the field of bioinformatics which will 
                accelerate the discovery or development of all types of 
                countermeasures by promoting the use of advanced 
                mathematical, computing, or image processing 
                technologies, including pattern recognition methods, 
                lossless digital data compression for storage and 
                transmission of biomedical images, and the ability to 
                analyze massive amounts of data, in order to solve 
                complex research and development problems.
    ``(d) Diagnostics Incentives.--
            ``(1) Identification.--Not later than 180 days after the 
        date of enactment of the Project BioShield II Act of 2005, the 
        Secretary shall develop and make available to potential 
        manufacturers, a list of the diagnostics that need to be 
        developed to prepare the United States for a terrorist attack 
        using a biological or chemical agent, infectious disease, 
        toxin, or nuclear or radiological materials, or to counter a 
        naturally occurring infectious disease outbreak. The Secretary 
        shall provide such information as the Secretary determines to 
        be necessary to enable such potential manufacturers to 
        structure and focus their research and development programs for 
        the development of such research tools.
            ``(2) Revisions.--The Secretary shall revise the list 
        developed under paragraph (1) not less often than annually, and 
        make such list available to potential manufacturers of 
        diagnostics under terms and conditions consistent with the 
        security interests of the United States.
            ``(3) Development of Certain Diagnostics.--
                    ``(A) In general.--The Secretary, acting through 
                the Assistant Secretary for Public Health 
                Countermeasure Development, shall develop and 
                implement, in consultation with State and local public 
                health officials and private sector entities, a 
                strategy for the development of infectious disease 
                multiplexed molecular level diagnostic screening 
                technologies and the building of an integrated and 
                standardized information system linking the Federal, 
                State, and local public health systems for reporting 
                automated laboratory results for all toxicology and 
                infectious diseases. The strategy shall address the 
                integration, correlation, and analysis from laboratory 
                results with data generated from environmental 
                monitoring using detection technology.
                    ``(B) Strategy.--The strategy developed and 
                implemented pursuant to subparagraph (A) shall--
                            ``(i) include the development of 
                        confirmatory laboratory tests to validate 
                        presumptive results available from initial 
                        screening;
                            ``(ii) complement the development of 
                        therapeutics where appropriate; and
                            ``(iii) promote the advancement of 
                        bioinformatics through the use of incentives, 
                        the procurement and rapid development of new 
                        devices, and the development of a robust and 
                        standardized information infrastructure for 
                        carrying out medical surveillance tasks.
                    ``(C) Technology.--
                            ``(i) In general.--The specific screening 
                        and diagnostics technology used to implement 
                        the strategy described in subparagraph (A) may 
                        consist of multiplexed devices that screen for 
                        routinely encountered common infectious 
                        diseases and have biothreat agent detection 
                        algorithms embedded in the devices with 
                        automatic reporting features.
                            ``(ii) Dissemination and evaluation.--The 
                        Secretary shall develop--
                                    ``(I) the methods by which the 
                                results from such detection devices may 
                                be rapidly disseminated to the 
                                appropriate domestic and international 
                                health care systems; and
                                    ``(II) a system by which the 
                                utility of such results, and the 
                                efficacy of such dissemination system, 
                                may be evaluated and improved, as 
                                necessary.
            ``(4) Utilization of diagnostics by health care 
        providers.--
                    ``(A) In general.--The Secretary shall develop and 
                implement a strategy that recognizes the need to 
                provide the right incentives to the health care 
                industry, including the qualified clinical 
                countermeasures delivery centers under the Project 
                Bioshield II Act of 2005, to allow the industry to 
                utilize the new diagnostic tools that will be made 
                available through research and allow for screening for 
                infectious diseases and other biological, chemical, 
                nuclear, radiological, and emerging terrorist threats.
                    ``(B) Reimbursement.--The strategy shall include 
                appropriate incentives to allow for reimbursement to 
                State and local governments, hospitals, clinics, and 
                other providers who perform laboratory screening 
                utilizing newer molecular level tests that rapidly 
                detect infectious diseases and other biological, 
                chemical, nuclear, radiological, and emerging terrorist 
                threats.
                    ``(C) Strategies.--The Secretary shall establish 
                similar strategies for States and local governments to 
                utilize to promote biological, chemical, nuclear, 
                radiological, and other emerging terrorist threats and 
                infectious diseases screening, including testing for 
                the rapid identification of potential biothreat agents.
            ``(5) No judicial review.--Notwithstanding any other 
        provision of law, there shall be no judicial review of the 
        list, or revised list, developed by the Secretary under this 
        subsection.
    ``(e) Research Tools Incentives.--
            ``(1) Identification.--Not later than 180 days after the 
        date of enactment of the Project BioShield II Act of 2005, the 
        Secretary shall develop and make available to potential 
        entities and manufacturers, a list of the research tools and 
        the systems to aid in the development of such tools that need 
        to be developed to prepare the United States for a terrorist 
        attack, with a biological or chemical agent or toxin or nuclear 
        or radiological materials, or to counter a naturally occurring 
        infectious disease outbreak. The list developed by the 
        Secretary shall include research tools for which there is a 
        need for development in order to understand why certain 
        countermeasures may cause adverse events, how to minimize such 
        adverse events, and how to treat such adverse events. The 
        Secretary shall provide such information as the Secretary 
        determines to be necessary to enable such potential 
        manufacturers to structure and focus their research and 
        development programs for the development of research tools.
            ``(2) Revisions.--The Secretary shall revise the list 
        developed under paragraph (1) not less often than annually, and 
        make such list available to potential manufacturers of research 
        tools under terms and conditions consistent with the security 
        interests of the United States.
            ``(3) No judicial review.--Notwithstanding any other 
        provision of law, there shall be no judicial review of the 
        list, or revised list, developed by the Secretary under this 
        subsection.
            ``(4) Utilization and availability.--
                    ``(A) In general.--Entities that enter into a 
                contract for procurement of a qualified countermeasure 
                under section 319F-1 or of a security countermeasure 
                under section 319F-2, or under section 512 of the 
                Homeland Security Act of 2002 shall maximize the 
                utilization of the research tools involved for the 
                development of countermeasures. In addition, such 
                entities shall promote the advancement of 
                bioinformatics through the use of incentives for the 
                development and procurement of bioinformatics research 
                tools.
                    ``(B) Rule of construction.--Nothing in this 
                section or chapter 18 of title 35, United States Code, 
                shall be construed to restrict the right of an entity 
                described in subparagraph (A) to--
                            ``(i) secure and enforce patents with 
                        regard to research tools;
                            ``(ii) enter into exclusive, revocable, and 
                        nontransferable licenses of such research 
                        tools; or
                            ``(iii) impose limits on royalty- or 
                        product-reach-through or downstream rights or 
                        agreements on future countermeasures or 
                        products, or option rights with respect to a 
                        research tool.
    ``(f) Initial List.--Not later than 180 days after the date of 
enactment of the Project BioShield II Act of 2005, the Secretary, in 
consultation with the Secretary of Defense and the Secretary of 
Homeland Security, shall develop, publish in the Federal Register, and 
make available to potential manufacturers of terror weapons and 
infectious disease countermeasures, except as provided in subsection 
(i), a list of biological and chemical agents, toxins, and nuclear and 
radiological materials that may be used as weapons of mass destruction 
or that are infectious diseases with respect the which the Secretary 
finds that research to develop new and improved countermeasures is in 
the national interest of the United States. Such initial list may, at 
the discretion of the Secretary, contain the following:
            ``(1) Variola major (confluent, flat, and hemorrhagic 
        smallpox).
            ``(2) Bacillus anthracis (anthrax) or near-neighbor 
        pathogenic Bacillus spp.
            ``(3) Clostridium botulinum (botulism) or botulism toxins.
            ``(4) Francisella tularensis (tularemia).
            ``(5) Yersina pestis (Black Death: bubonic plague, 
        pneumonic plague).
            ``(6) Pathogenic Haemophilus spp.
            ``(7) Ebolavirus spp. (Ebola hemorrhagic fever).
            ``(8) Marburgvirus spp. (Marburg hemorrhagic fever).
            ``(9) Arenavirus Lassa Virus (Lassa fever).
            ``(10) Arenavirus Junin Virus (Argentine hemmorrhagic 
        fever).
            ``(11) Nairovirus Crimean-Congo hemorrhagic fever virus 
        (Crimean-Congo hemmorrhagic fever).
            ``(12) Coxiella burnetti (Q fever).
            ``(13) Coccidioidomycosis immitis (Coccidioidomycosis, San 
        Joaquin Valley, or desert fever).
            ``(14) Clostridium perfringens (gas gangrene, necrotizing 
        enteritis).
            ``(15) Treponema spp.
            ``(16) Borrelia spp.
            ``(17) Chlamydia psittaci (parrot fever).
            ``(18) Phlebovirus Rift Valley fever virus (Rift Valley 
        fever).
            ``(19) Rickettsia rickettsii (Rocky Mountain Spotted 
        Fever).
            ``(20) Brucella spp. (brucellosis).
            ``(21) Burkholderia mallei (glanders).
            ``(22) Alphavirus Venezuelan equine encephalitis virus 
        (Venezuelan equine encephalomyelitis).
            ``(23) Alphavirus Eastern equine encephalitis virus 
        (Eastern equine encephalomyelitis) and Alphavirus Western 
        equine encephalitis virus (Western equine encephalomyelitis).
            ``(24) Ricin toxin (castor bean toxin).
            ``(25) Trichothecene Mycotoxins.
            ``(26) Dinoflagellate neurotoxin (Paralytic Shellfish 
        Toxin).
            ``(27) Aflatoxins.
            ``(28) Epsilon toxin of clostridium perfringens.
            ``(29) Staphylococcus enterotoxin B (Staphylococcus 
        entertoxin B intoxication).
            ``(30) Methicillin-resistant staphylococcus aureus.
            ``(31) Influenza.
            ``(32) Avian influenza.
            ``(33) Pathogenic Salmonella spp. (gastrointestinal upset, 
        enteric fever).
            ``(34) Salmonella Typhi (typhoid fever).
            ``(35) Shigella dysenteriae (dysentery, hemolytic-uremic 
        syndrome).
            ``(36) Escherichia coli 0157:H7 (severe diarrhea, 
        hemolytic-uremic syndrome) and other Escherichia coli 
        pathotypes.
            ``(37) Vibrio species (cholera).
            ``(38) Toxoplasma gondii.
            ``(39) Cryptosporidium parvum.
            ``(40) Henipavirus Nipah virus (Nipa encephalitis).
            ``(41) Hantavirus spp. (Hantavirus Pulmonary Syndrome).
            ``(42) Tickborne hemorrhagic fever viruses.
            ``(43) Tickborne encephalitis virus.
            ``(44) Flavivirus Yellow Fever virus (Yellow fever, West 
        Nile virus, Dengue).
            ``(45) Human Immunodeficiency Virus (HIV), Acquired Immune 
        Deficiency Syndrome (AIDS)
            ``(46) Plasmodium falciparum, P. ovale, P. vivax, P. 
        malariae (Malaria).
            ``(47) Rickettsia typhi (typhus).
            ``(48) Antibiotic-resistant Mycobacterium tuberculosis.
            ``(49) Entamoeba histolytica (amebiasis).
            ``(50) Pathogenic Shigella spp. (bacillary dysentery, 
        Shigellosis).
            ``(51) Giardia lamblia (giardiasis).
            ``(52) Orthopox virus spp. (monkey pox infection).
            ``(53) Trypanosoma brucei gambiense or rhodesiense 
        (trypanosomiasis, sleeping sickness).
            ``(54) Leishmania donovane (visceral leishmaniasis, black 
        fever, Kala Azar).
            ``(55) Schistosoma mansoni, S. haematobium, S. japonicum 
        (schistosomiasis or bilharzia).
            ``(56) Necator Americanus and Ancylostoma duodenale 
        (hookworm).
            ``(57) Ascaris lumbricoides (roundworm).
            ``(58) Trichuris trichiura (whipworm).
            ``(59) Onchocerca volvulus (river blindness).
            ``(60) Drancunculus medianensis (guinea worm).
            ``(61) Wuchereria bancrofti and Brugia malayi (lymphatic 
        filariasis or elephantiasis).
            ``(62) Mycobacterium ulcerans (Burulu Ulcer).
            ``(63) Mycobacterium leprea (leprosy).
            ``(64) Chlamydia trachomitis (Trachoma).
            ``(65) Pathogenic Streptococcus spp.
            ``(66) Nerve agents (including Tabun, Sarin, Soman, GF, VX, 
        V-gas, third generation nerve agents organophosphate pesticides 
        add carbamate insecticides).
            ``(67) Blood agents (including hydrogen cyanide and 
        cyanogen chloride).
            ``(68) Blister agents (including Lewisite, nitrogen and 
        sulfur mustards).
            ``(69) Heavy metals (including arsenic, lead, and mercury).
            ``(70) Volatile toxins (including benzene, chloroform, and 
        trihalomethanes).
            ``(71) Pulmonary agents (including phosgene and chlorine 
        vinyl chloride).
            ``(72) Incapacitating agents (including BZ).
            ``(73) Nuclear and radiological materials.
            ``(74) Exotic agents including hybrid organisms, 
        genetically modified organisms, antibiotic-induced toxins, 
        autoimmune peptides, immune mimicry agents, binary bioweapons, 
        stealth viruses, and bioregulators and biomodulators.
            ``(75) Innovative treatments and measures to address 
        trauma, including excessive bleeding, resulting from an act of 
        terrorism.
            ``(76) Any other new and emerging natural infectious 
        disease threats.
    ``(g) Revisions.--The Secretary shall revise the list developed 
under subsection (f) on at least an annual basis, and make such list 
available, under the terms and limitations described in this section, 
to potential manufacturers of terror weapons countermeasures, 
infectious disease countermeasures, or weapons of mass destruction 
countermeasures, or to holders of approved certifications. Such terms 
and conditions shall be consistent with the security interests of the 
United States.
    ``(h) No Judicial Review.--Notwithstanding any other provision of 
law, there shall be no judicial review of the Secretary's 
determinations regarding which agents, toxins, or materials to include 
on the list, or revised list, developed under this section or of a 
determination to exempt information from public distribution under this 
section.
    ``(i) Exemption.--
            ``(1) In general.--The Secretary may exempt certain 
        information concerning weapons of mass destruction from 
        publication if the Secretary determines that such publication 
        would be detrimental to the security of the United States. In 
        providing an exemption under the preceding sentence, the 
        Secretary shall develop procedures for making such list or 
        information available on a confidential basis to potential 
        manufacturers of countermeasures.
            ``(2) Sufficiency of information.--In developing the 
        procedures described in paragraph (1), the Secretary shall 
        ensure that the information provided to potential manufacturers 
        of countermeasures is sufficient to enable the Federal 
        Government and the manufacturer to determine when such a 
        manufacturer has successfully developed a countermeasure and 
        therefore becomes entitled to the procurement, intellectual 
        property, and liability provisions of title III of the Project 
        BioShield II Act of 2005 (and the amendments made by such 
        title).''.
    (b) Detection Technology Incentives.--Section 512 of the Homeland 
Security Act of 2002 (as added by section 101), is amended by--
            (1) redesignating subsection (b) as subsection (d); and
            (2) inserting after subsection (a) the following:
    ``(b) Detectors Technology Incentives.--
            ``(1) Identification.--
                    ``(A) In general.--Not later than 180 days after 
                the date of enactment of the Project BioShield II Act 
                of 2005, the Secretary shall develop and make available 
                to potential manufacturers, a list of the infectious 
                disease, biological, chemical, radiological, or nuclear 
                agents to be detected as well as the name and seller of 
                the detection technology furnished to the Government 
                and whether the Secretary has certified such detection 
                technology under section 301(b)(4) of the Project 
                BioShield II Act of 2005. The detection targets shall 
                include chemical or biological agents or toxins or 
                nuclear or radiological materials.
                    ``(B) Availability of information.--The Secretary 
                shall provide such information as the Secretary 
                determines to be necessary to enable the potential 
                manufacturers of terror weapons and infectious disease 
                detection technology to structure and focus their 
                research and development programs for the development 
                of such technology.
                    ``(C) Revisions.--The Secretary shall revise the 
                list developed under subparagraph (A) not less often 
                than annually, and make such list available to 
                potential manufacturers of terror weapons and 
                infectious disease detections equipment under terms and 
                conditions consistent with the security interests of 
                the United States.
                    ``(D) No judicial review.--Notwithstanding any 
                other provision of law, there shall be no judicial 
                review of the determinations by the Secretary regarding 
                which agents, toxins, or materials are to be included 
                on the list, or revised list, developed under this 
                subsection.
                    ``(E) Consultation.--In developing and revising the 
                list described under subparagraph (A), the Secretary 
                shall consult with the Secretary of Health and Human 
                Services and the Secretary of Defense.
                    ``(F) Exemption.--
                            ``(i) In general.--The Secretary may exempt 
                        certain information concerning weapons of mass 
                        destruction from publication under this 
                        subsection if the Secretary determines that 
                        such publication would be detrimental to the 
                        security of the United States. In providing an 
                        exemption under the preceding sentence, the 
                        Secretary shall develop procedures for making 
                        such list or information available on a 
                        confidential basis to potential manufacturers 
                        of countermeasures.
                            ``(ii) Sufficiency of information.--In 
                        developing the procedures described in clause 
                        (i), the Secretary shall ensure that the 
                        information provided to potential manufacturers 
                        of countermeasures is sufficient to enable the 
                        Federal Government and the manufacturer to 
                        determine when such a manufacturer has 
                        successfully developed a countermeasure and 
                        therefore becomes entitled to the procurement, 
                        intellectual property, and liability provisions 
                        of title III of the Project BioShield II Act of 
                        2005 (and the amendments made by such title).
            ``(2) Other detection technology incentives.--
                    ``(A) In general.--In furnishing the list to 
                potential vendors of detection technology, the 
                Secretary shall promote the advancement of 
                bioinformatics through the use of incentives for 
                bioinformatics research tools to develop detection 
                technology.
                    ``(B) Cooperation.--The Secretary shall cooperate 
                with the Secretary of the Department of Homeland 
                Security and in consultation with the appropriate 
                Advisory Committees, in the course of DHS certification 
                of detection technology countermeasures, to generate 
                performance measures or performance standards (such as 
                `time to result', `sensitivity', or `specificity' with 
                respect to a target pathogen) for such detection 
                technology countermeasures.
    ``(c) Decontamination Technology Incentives.--
            ``(1) Identification.--
                    ``(A) In general.--Not later than 180 days after 
                the date of enactment of the Project BioShield II Act 
                of 2005, the Secretary shall develop and make available 
                to potential manufacturers, a list of the infectious 
                disease, biological, chemical, radiological, or nuclear 
                agents for which decontamination technology is 
                necessary as well as the name and seller of the 
                decontamination technology furnished to the Government 
                and whether the Secretary has certified such 
                decontamination technology under section 301(b)(4) of 
                the Project BioShield II Act of 2005. The 
                decontamination targets shall include chemical or 
                biological agents or toxins or nuclear or radiological 
                materials.
                    ``(B) Availability of information.--The Secretary 
                shall provide such information as the Secretary 
                determines to be necessary to enable the potential 
                manufacturers of terror weapons and infectious disease 
                decontamination technology to structure and focus their 
                research and development programs for the development 
                of such technology.
                    ``(C) Revisions.--The Secretary shall revise the 
                list developed under subparagraph (A) not less often 
                than annually, and make such list available to 
                potential manufacturers of terror weapons and 
                infectious disease decontamination equipment under 
                terms and conditions consistent with the security 
                interests of the United States.
                    ``(D) No judicial review.--Notwithstanding any 
                other provision of law, there shall be no judicial 
                review of the determinations by the Secretary regarding 
                which agents, toxins, or materials are to be included 
                on the list, or revised list, developed under this 
                subsection.
                    ``(E) Consultation.--In developing and revising the 
                list described under subparagraph (A), the Secretary 
                shall consult with the Secretary of Health and Human 
                Services and the Secretary of Defense.
                    ``(F) Exemption.--
                            ``(i) In general.--The Secretary may exempt 
                        certain information concerning weapons of mass 
                        destruction from publication under this 
                        subsection if the Secretary determines that 
                        such publication would be detrimental to the 
                        security of the United States. In providing an 
                        exemption under the preceding sentence, the 
                        Secretary shall develop procedures for making 
                        such list or information available on a 
                        confidential basis to potential manufacturers 
                        of countermeasures.
                            ``(ii) Sufficiency of information.--In 
                        developing the procedures described in clause 
                        (i), the Secretary shall ensure that the 
                        information provided to potential manufacturers 
                        of countermeasures is sufficient to enable the 
                        Federal Government and the manufacturer to 
                        determine when such a manufacturer has 
                        successfully developed a countermeasure and 
                        therefore becomes entitled to the procurement, 
                        intellectual property, and liability provisions 
                        of title III of the Project BioShield II Act of 
                        2005 (and the amendments made by such 
                        title).''.
    (d) Negotiations With Foreign Governments.--The Secretary of 
Homeland Security shall enter into negotiations with foreign 
governments and organizations to secure coordination and reciprocity 
among the applicable regulatory agencies responsible for approving and 
licensing countermeasures, including diagnostics, vaccines, and drugs 
to prevent, treat, detect, or identify, an infectious disease.

SEC. 203. ANNUAL REPORT.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) (as amended by sections 202, 1401, 1631, 1901, 2101, and 2102) 
is amended by inserting after section 319F-8 (as added by section 1631) 
the following:

``SEC. 319F-9. ANNUAL REPORT.

    ``(a) In General.--
            ``(1) Submission of report.--Not later than January 1, 
        2006, and each January 1 thereafter, the Secretary shall submit 
        to the appropriate committees of Congress, and make available 
        to the public, a report concerning the implementation of 
        sections 319F-4 through 319F-8 and the amendments made by title 
        III of the Project BioShield II Act of 2005.
            ``(2) Content of report.--Reports under paragraph (1) shall 
        include--
                    ``(A) an assessment of whether the incentives 
                provided for under sections 319F-4 through 319F-8 and 
                such amendments are sufficient, as determined by the 
                Secretary, to induce the biotechnology, pharmaceutical, 
                device, and research tool industries to modify their 
                ongoing research priorities and devote management and 
                scientific talent to researching the development of 
                priority countermeasures, detections equipment, 
                diagnostics, research tools, or drugs intended to 
                directly prevent or treat the pathological and 
                physiological effects of exposures to biological, 
                chemical, nuclear, radiological, and other emerging 
                bioterrorist threats and infectious diseases;
                    ``(B) an assessment of whether such incentives are 
                sufficient, as determined by the Secretary, to address 
                the sensitivity of such industries to the possibility 
                of challenges to their prices and patents and the terms 
                of sales that may arise when the Federal Government is 
                an oligopoly or monopoly purchaser;
                    ``(C) an assessment of whether such incentives are 
                likely to lead to the development of countermeasures 
                and implementation through the qualified clinical 
                countermeasures delivery centers to prepare the United 
                States in the event of the use by terrorists and others 
                of biological, chemical, nuclear, or radiological 
                weapons against military or intelligence, Government, 
                and civilian population of the United States;
                    ``(D) an assessment of whether such incentives will 
                lead to the development of research tools;
                    ``(E) an assessment of whether such provisions are 
                achieving the goal of securing the United States from 
                bioterror attacks and infectious disease outbreaks;
                    ``(F) an assessment of whether the incentivies of 
                the Project BioShield II Act of 2005 are being abused 
                by sponsors seeking expanded market protection for non-
                countermeasure products based on the development of 
                countermeasures that are marginally useful or that 
                require minimal research and development efforts;
                    ``(G) an accounting of the additional healthcare 
                costs to consumers, healthcare providers, and 
                government payors due to the application of the 
                marketing protection incentivies of such Act;
                    ``(H) a description of how such incentives for 
                private sector research relate to the provision of 
                public funding for the development of countermeasures; 
                and
                    ``(I) recommendations to increase or decrease the 
                effectiveness of such incentives.
    ``(b) Limitation on Publication.--The Secretary may exempt 
information from disclosure to the public under subsection (a) if the 
Secretary determines that such publication may be detrimental to the 
security of the United States. Such determinations by the Secretary 
shall not be subject to judicial review.''.

SEC. 204. USE OF FUNDS; REQUIREMENTS OF MANUFACTURERS.

    (a) In General.--The Secretary of Health and Human Services may use 
funds appropriated for the Strategic National Stockpile under section 
319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) or under 
any other provision of law for the storage, maintenance, security, 
rotation, and transport of any material purchased for such stockpile.
    (b) Requirements of Manufacturers.--The Secretary of Health and 
Humans Services shall provide to manufacturers, to the extent 
practicable, the logistical and operational requirements of 
countermeasures prior to their development and acquisition. The 
logistical and operational requirements shall consider public health 
needs as well as requirements for storage, maintenance, security, 
rotation, and transport of any countermeasures purchased under the 
authority of the Project BioShield Act of 2004.

 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.

    (a) Definitions.--For purposes of this title, the term 
``countermeasure'' has the meaning given that term in section 319F-3 of 
the Public Health Service Act (as added by section 101), and the terms 
``countermeasure product'', ``eligible patent'' and ``designated 
product'' have the meanings given such terms in section 156(a) of title 
35, United States Code (as added by section 331).
    (b) Certification Requirements.--
            (1)  In general.--An entity described in paragraph (2) may 
        submit to the Secretary of Health and Human Services (referred 
        to in this subtitle as the ``Secretary'') with respect to 
        agreements for procurement entered into under section 319F-1 or 
        319F-2 of the Public Health Service Act (42 U.S.C. 247d-6a or 
        247d-6b), or to the Secretary of Homeland Security with respect 
        to agreements for procurement entered into under section 512 of 
        the Homeland Security Act of 2002 (as added by section 202), an 
        application for certification that--
                    (A) the entity may receive a patent term extension 
                under the provisions of section 158 of title 35, United 
                States Code (as added by section 331), and the duration 
                of any such extension; and
                    (B) the entity has successfully developed a 
                countermeasure under an agreement described in 
                paragraph (2)(C).
            (2)  Entity described.--An entity described under this 
        paragraph is an entity that--
                    (A) operates a private sector establishment;
                    (B) is engaged in the conduct of research to 
                develop a countermeasure; and
                    (C) enters into an agreement for procurement with 
                the Secretary under the authority provided in section 
                319F-1 or 319F-2 of the Public Health Service Act (42 
                U.S.C. 247d-6a or 247d-6b), or with the Secretary of 
                Homeland Security under section 512 of the Homeland 
                Security Act of 2002 (as added by section 101).
            (3) Successful development of a countermeasure.--For the 
        purposes of this section, an entity shall be deemed to have 
        successfully developed a countermeasure if, after the date the 
        entity enters into an agreement for procurement with the 
        Secretary under the authority provided in section 319F-1 or 
        319F-2 of the Public Health Service Act (42 U.S.C. 247d-6a or 
        247d-6b), or with the Secretary of Homeland Security under 
        section 512 of the Homeland Security Act of 2002 as added by 
        section 101, either--
                    (A) the entity has met the requirements specified 
                in the contract for procurement under section 319F-1 or 
                319F-2 of the Public Health Service Act (42 U.S.C. 
                247d-6a or 247d-6b)) or under section 512 of the 
                Homeland Security Act of 2002; or
                    (B) the countermeasure has been approved under 
                sections 505 or 513 of the Federal Food Drug and 
                Cosmetic Act (21 U.S.C. 355) or section 351 of the 
                Public Health Service Act; (42 U.S.C. 262), as 
                appropriate.
            (4)  Certifications by secretary.--
                    (A) Certification as to eligibility for special 
                patent term extension.--
                            (i) In general.--An entity, prior to the 
                        date it has successfully developed a 
                        countermeasure product, may request that the 
                        Secretary determine if the entity is entitled 
                        to receive an extension of the term of an 
                        eligible patent under section 158 of title 35, 
                        United States Code (as added by section 331), 
                        and the duration of any such extension.
                            (ii) Factors considered.--The Secretary 
                        shall consider the following factors in making 
                        the determinations specified in clause (i)--
                                    (I) the nature of the terror 
                                threats to be countered and the 
                                importance of developing the 
                                countermeasures in question to respond 
                                to such threat;
                                    (II) the difficulty, risk, and 
                                expense likely to be associated with 
                                the development of such countermeasure;
                                    (III) the existence or non-
                                existence of practical alternatives to 
                                the countermeasure to be developed;
                                    (IV) whether review of the safety 
                                and effectiveness of the countermeasure 
                                product will require reports from 
                                clinical investigations of the 
                                countermeasure product; and
                                    (V) the impact of the patent 
                                extension on consumers and healthcare 
                                providers.
                            (iii) Limitation.--The Secretary may 
                        determine that an extension under this section 
                        is available only if the countermeasure product 
                        involved--
                                    (I) contains an active ingredient 
                                (including any ester or salt of the 
                                active ingredient) which has not been 
                                approved in another application under 
                                section 505(b) of the Federal Food, 
                                Drug, and Cosmetic Act (21 U.S.C. 
                                355(b)); and
                                    (II) is superior to a previously 
                                available drug, antibiotic drug, 
                                biological product, device, detection 
                                technology, or research tool.
                            (iv) Limitation on extensions.--Any 
                        extension authorized by the Secretary shall not 
                        exceed 2 years, and shall not be less than 6 
                        months, in duration.
                            (v) Written determination.--The Secretary 
                        shall provide an entity that requests a 
                        determination under clause (i) with a written 
                        determination on the eligibility of that entity 
                        for a patent term extension under section 158 
                        of title 35, United States Code (as added by 
                        section 331), and the duration of any such 
                        extension.
                            (vi) Effect of section.--The Secretary 
                        shall promulgate regulations to give effect to 
                        this section.
                    (B) Written notice of entity developing 
                countermeasure.--
                            (i) In general.--Not later than 180 days 
                        after entering a contract with the Secretary of 
                        Health and Human Services under section 319F-1 
                        or 319F-2 of the Public Health Service Act (42 
                        U.S.C. 247d-6a or 247d-6b) or with the 
                        Secretary of Homeland Security under section 
                        512 of the Homeland Security Act of 2002 (as 
                        added by section 101) for the procurement of a 
                        countermeasure for which the Secretary of 
                        Health and Human Services or the Secretary of 
                        Homeland Security, as appropriate, has 
                        determined that a patent extension is available 
                        under section 158 of title 35, United States 
                        Code (as added by section 331), the entity that 
                        enters such contract shall notify such 
                        appropriate Secretary of the patent that would 
                        be extended if such entity received a 
                        certification under section 301(b)(4)(A).
                            (ii) Publication of information.--The 
                        Secretary of Health and Human Services, with 
                        respect to a contract under such section 319F-1 
                        or 319F-2 of the Public Health Service Act, or 
                        the Secretary of Homeland Security, with 
                        respect to a contract under such section 512 of 
                        the Homeland Security Act of 2002, shall 
                        publish in the Federal Register the information 
                        provided in a notification received under 
                        clause (i).
                            (iii) Irrevocable election.--An submission 
                        of a notification by an entity under clause (i) 
                        shall constitute an irrevocable election of the 
                        patent extended under section 158 of title 35, 
                        United States Code, except that such entity may 
                        elect to restore the term of the eligible 
                        patent under section 156a of title 35, United 
                        States Code, instead of extending the term of 
                        the patent under such section 158 on the basis 
                        of the successful development of the 
                        countermeasure.
                    (C) Certification as to successful development.--
                With respect to an application for certification 
                submitted by an entity in accordance with the terms of 
                the agreement for procurement described under paragraph 
                (2)(C), the Secretary or the Secretary of Homeland 
                Security, as appropriate, shall--
                            (i) determine if the entity has 
                        successfully developed the countermeasure 
                        involved;
                            (ii) provide the notice required under 
                        subparagraph (B);
                            (iii) approve or deny the application for 
                        certification; and
                            (iv) notify such entity of and publish such 
                        approval or denial, and the reasons therefore.
                    (D) Effects of certification.--If the Secretary or 
                Secretary of Homeland Security certifies the 
                application of an entity under paragraph (3)(A), such 
                entity--
                            (i) shall receive payment under the 
                        contract described in paragraph (2)(C);
                            (ii) may utilize the patent restoration and 
                        extension protection under section 156a and 158 
                        of title 35, United States Code (as added by 
                        section 331);
                            (iii) may utilize the marketing exclusivity 
                        provisions of section 505(c)(3)(E) and 
                        505(j)(5)(F) of the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 355(c)(3)(E) and 21 
                        U.S.C. 355(j)(5)(E)); and
                            (iv) may utilize the liability protections 
                        described under this title (and the amendments 
                        made by this title).
    (c) Rule of Construction.--Nothing in this section shall be 
construed to restrict the authority of the Secretary (with respect to 
procurement agreements under section 319F-1 or 319F-2 of the Public 
Health Service Act (42 U.S.C. 247d-6a or 247d-6b)) or the Secretary of 
Homeland Security (with respect to procurement agreements under section 
512 of the Homeland Security Act of 2002 (as added by section 101) to 
permit an entity to utilize the liability protections described under 
this title (and the amendments made by this title) or to receive 
payment under the agreement described in subsection (b)(2)(C) prior to 
the approval of the application for certification submitted by the 
entity pursuant to the terms of such agreement.
    (d) Judicial Review.--A determination by the Secretary or the 
Secretary of Homeland Security, as appropriate, under subsection (b) 
shall constitute final agency action subject to judicial review. A 
prevailing plaintiff in an action challenging an adverse determination 
by the Secretary or Secretary of Homeland Security under such 
subsection may be awarded reasonable attorneys fees under section 2412 
of title 28, United States Code.

                   Subtitle B--Federal Tax Incentives

SEC. 311. GENERAL PROVISIONS.

    (a) In General.--Any entity which enters into a contract for 
procurement with the Secretary under the authority provided in section 
319F-1 or 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6a or 
247d-6b) or under section 512 of the Homeland Security Act of 2002 (as 
added by section 101) may irrevocably elect 1 of the following Federal 
tax incentives to fund research with respect to each contract to 
develop countermeasures (as that term is defined in section 319F-3 of 
the Public Health Service Act (as added by section 202)):
            (1) Research and development limited partnerships to fund 
        countermeasure research.--The entity may establish a limited 
        partnership for the countermeasures, but only if such entity is 
        a qualified small business as determined under section 1202(d) 
        of the Internal Revenue Code of 1986, by substituting 
        ``$750,000,000'' for ``$50,000,000'' each place it appears. For 
        purposes of the Internal Revenue Code of 1986, section 469 of 
        such Code shall not apply with respect to a limited partnership 
        established under this paragraph.
            (2) Capital gains exclusion for investors to fund 
        countermeasure research.--The entity may issue a class of stock 
        for the countermeasures under section 1202 of the Internal 
        Revenue Code of 1986 with the following modifications:
                    (A) Increased exclusion for noncorporate 
                taxpayers.--Subsection (a) of section 1202 of such Code 
                shall be applied by substituting ``100 percent'' for 
                ``50 percent''.
                    (B) Application to corporate taxpayers.--Subsection 
                (a) of section 1202 of such Code shall be applied 
                without regard to the phrase ``other than a 
                corporation''.
                    (C) Stock of larger businesses eligible for 
                exclusion.--Paragraph (1) of section 1202(d) of such 
                Code (defining qualified small business) shall be 
                applied by substituting ``$750,000,000'' for 
                ``$50,000,000'' each place it appears.
                    (D) Reduction in holding period.--Subsection (a) of 
                section 1202 of such Code shall be applied by 
                substituting ``3 years'' for ``5 years''.
                    (E) Nonapplication of per-issuer limitation.--
                Section 1202 of such Code shall be applied without 
                regard to subsection (b) (relating to per-issuer 
                limitations on taxpayer's eligible gain).
                    (F) Modification of working capital limitation.--
                Section 1202(e)(6) of such Code shall be applied--
                            (i) in subparagraph (B), by substituting 
                        ``5 years'' for ``2 years'', and
                            (ii) without regard to the last sentence.
                    (G) Nonapplication of minimum tax preference.--
                Section 57(a) of such Code shall be applied without 
                regard to paragraph (7).
            (3) Tax credits to fund countermeasure research.--The 
        entity may be eligible for the tax credits provided for in 
        section 312.
    (b) Reporting; Recapture.--
            (1) Reporting.--Each entity described in subsection (a) 
        shall submit to the Secretary and the Secretary of the Treasury 
        such information regarding its election of any tax incentive 
        under this section with respect to any contract described in 
        subsection (a) as the Director of the National Institutes of 
        Health and the Secretary of Health and Human Services determine 
        necessary to carry out the enforcement provisions prescribed 
        under paragraph (2).
            (2) Recapture.--The Secretary of the Treasury, in 
        consultation with the Director of the National Institutes of 
        Health and the Secretary of Health and Human Services, shall 
        provide for the recapture of any tax benefits resulting from 
        any elected tax incentive under this section if the resulting 
        research is for a purpose other than that specified in such 
        contract.
    (c) Effective Date.--The provisions of this section shall apply to 
taxable years beginning after December 31, 2004.

SEC. 312. TAX CREDITS.

    (a) Amendments to the Internal Revenue Code.--
            (1) Tax credit to fund countermeasure research.--
                    (A) In general.--Subpart D of part IV of subchapter 
                A of chapter 1 of the Internal Revenue Code of 1986 
                (relating to business-related credits) is amended by 
                adding at the end the following new section:

``SEC. 45J. CREDIT FOR MEDICAL RESEARCH RELATED TO DEVELOPING 
              COUNTERMEASURES.

    ``(a) General Rule.--For purposes of section 38, in the case of any 
entity described in section 311(a) of the Project BioShield II Act of 
2005 which makes an election under such section to apply this section, 
the countermeasures research credit determined under this section for 
the taxable year is an amount equal to 35 percent of the eligible 
countermeasures research expenses for the taxable year.
    ``(b) Eligible Countermeasures Research Expenses.--For purposes of 
this section--
            ``(1) Eligible countermeasures research expenses.--
                    ``(A) In general.--Except as otherwise provided in 
                this paragraph, the term `eligible countermeasures 
                research expenses' means the amounts which are paid or 
                incurred by the taxpayer during the taxable year with 
                respect to any contract described in section 311(a) of 
                the Project BioShield II Act of 2005 which would be 
                described in subsection (b) of section 41 if such 
                subsection were applied with the modifications set 
                forth in subparagraph (B).
                    ``(B) Modifications; increased incentive for 
                contract research payments.--For purposes of 
                subparagraph (A), subsection (b) of section 41 shall be 
                applied--
                            ``(i) by substituting `eligible 
                        countermeasures research' for `qualified 
                        research' each place it appears in paragraphs 
                        (2) and (3) of such subsection, and
                            ``(ii) by substituting `100 percent' for 
                        `65 percent' in paragraph (3)(A) of such 
                        subsection.
                    ``(C) Exclusion for amounts funded by grants, 
                etc.--The term `eligible countermeasures research 
                expenses' shall not include any amount to the extent 
                such amount is funded by any grant, contract, or 
                otherwise by another person (or any governmental 
                entity).
            ``(2) Countermeasures research.--The term `countermeasures 
        research' means research conducted by an entity with respect to 
        the development of countermeasures (as defined in section 319F-
        3 of the Public Health Service Act).
    ``(c) Coordination With Credit for Increasing Research 
Expenditures.--
            ``(1) In general.--Except as provided in paragraph (2), any 
        eligible countermeasures research expenses for a taxable year 
        to which an election under this section applies shall not be 
        taken into account for purposes of determining the credit 
        allowable under section 41 for such taxable year.
            ``(2) Expenses included in determining base period research 
        expenses.--Any eligible countermeasures research expenses for 
        any taxable year which are qualified research expenses (within 
        the meaning of section 41(b)) shall be taken into account in 
        determining base period research expenses for purposes of 
        applying section 41 to subsequent taxable years.
    ``(d) Coordination With Credit for Clinical Testing Expenses for 
Certain Drugs for Rare Diseases.--Any eligible countermeasures research 
expense for a taxable year shall not be taken into account for purposes 
of determining the credit allowable under section 45C for such taxable 
year.
    ``(e) Special Rules.--
            ``(1) Pre-clinical research.--No credit shall be allowed 
        under this section for pre-clinical research unless such 
        research is pursuant to a research plan an abstract of which 
        has been filed with the Food and Drug Administration before the 
        beginning of such year. This paragraph shall be waived for any 
        research that is pursuant to a research plan or abstract that 
        has been filed with the Food and Drug Administration not later 
        than 270 days after the date of enactment of this section. The 
        Secretary of Health and Human Services shall prescribe 
        regulations specifying the requirements for such plans and 
        procedures for filing under this paragraph.
            ``(2) Certain rules made applicable.--Rules similar to the 
        rules of paragraphs (1) and (2) of section 41(f) shall apply 
        for purposes of this section.''.
                    (B) Inclusion in general business credit.--Section 
                38(b) of such Code is amended by striking ``plus'' at 
                the end of paragraph (18), by striking the period at 
                the end of paragraph (19) and inserting ``, plus'', and 
                by adding at the end the following new paragraph:
            ``(20) the countermeasures research credit determined under 
        section 45J.''.
                    (C) Denial of double benefit.--Section 280C of such 
                Code is amended by adding at the end the following new 
                subsection:
    ``(e) Credit for Eligible Countermeasures Research Expenses.--
            ``(1) In general.--No deduction shall be allowed for that 
        portion of the eligible countermeasures research expenses (as 
        defined in section 45J(b)) otherwise allowable as a deduction 
        for the taxable year which is equal to the amount of the credit 
        determined for such taxable year under section 45J(a).
            ``(2) Certain rules to apply.--Rules similar to the rules 
        of paragraphs (2), (3), and (4) of subsection (c) shall apply 
        for purposes of this subsection.''.
                    (D) Deduction for unused portion of credit.--
                Section 196(c) of such Code (defining qualified 
                business credits) is amended by striking ``and'' at the 
                end of paragraph (11), by striking the period at the 
                end of paragraph (12) and inserting ``, and'', and by 
                adding at the end the following new paragraph:
            ``(13) the countermeasures research credit determined under 
        section 45J(a) (other than such credit determined under the 
        rules of section 280C(e)(2)).''.
                    (E) Technical amendment.--The table of sections for 
                subpart D of part IV of subchapter A of chapter 1 of 
                such Code is amended by adding at the end the following 
                new item:

                              ``Sec. 45J. Credit for medical research 
                                        related to developing 
                                        countermeasures.''.
            (2) Tax credit to fund countermeasure research at certain 
        qualified non-profit and academic institutions including 
        teaching hospitals.--
                    (A) In general.--Subpart D of part IV of subchapter 
                A of chapter 1 of the Internal Revenue Code of 1986 
                (relating to business related credits) is amended by 
                inserting after section 41 the following:

``SEC. 41A. CREDIT FOR COUNTERMEASURES RESEARCH EXPENSES.

    ``(a) General Rule.--For purposes of section 38, in the case of any 
entity described in section 311(a) of the Project BioShield II Act of 
2005 which makes an election under such section to apply this section, 
the countermeasures research credit determined under this section for 
the taxable year shall be an amount equal to 35 percent of the excess 
(if any) of--
            ``(1) the eligible countermeasures research expenses for 
        the taxable year, over
            ``(2) the countermeasures base period amount.
    ``(b) Eligible Countermeasures Research Expenses.--For purposes of 
this section--
            ``(1) In general.--The term `eligible countermeasures 
        research expenses' means the amounts which are paid or incurred 
        by the taxpayer during the taxable year directly or indirectly 
        to any qualified nonprofit or academic institution for 
        countermeasures research activities with respect to any 
        contract described in section 311(a) of the Project BioShield 
        II Act of 2005.
            ``(2) Countermeasures research activities.--
                    ``(A) In general.--The term `countermeasures 
                research activities' means research conducted by an 
                entity with respect to the development of 
                countermeasures (as defined in section 319F-3 of the 
                Public Health Service Act), conducted at any qualified 
                nonprofit or academic institution in the development of 
                any product, which occurs before--
                            ``(i) the date on which an application with 
                        respect to such product is approved under 
                        section 505(b), 506, or 507 of the Federal 
                        Food, Drug, and Cosmetic Act,
                            ``(ii) the date on which a license for such 
                        product is issued under section 351 of the 
                        Public Health Service Act, or
                            ``(iii) the date classification or approval 
                        of such product which is a device intended for 
                        human use is given under section 513, 514, or 
                        515 of the Federal Food, Drug, and Cosmetic 
                        Act.
                    ``(B) Product.--The term `product' means any drug, 
                biologic, medical device, or research tool.
            ``(3) Qualified nonprofit or academic institution.--The 
        term `qualified nonprofit or academic institution' means any of 
        the following institutions:
                    ``(A) Educational institution.--A qualified 
                organization described in section 170(b)(1)(A)(iii) 
                which is owned or affiliated with an institution of 
                higher education as described in section 3304(f).
                    ``(B) Teaching hospital.--A teaching hospital 
                which--
                            ``(i) is publicly supported or owned by an 
                        organization described in section 501(c)(3), 
                        and
                            ``(ii) is affiliated with an organization 
                        meeting the requirements of subparagraph (A).
                    ``(C) Foundation.--A medical research organization 
                described in section 501(c)(3) (other than a private 
                foundation) which is affiliated with, or owned by--
                            ``(i) an organization meeting the 
                        requirements of subparagraph (A), or
                            ``(ii) a teaching hospital meeting the 
                        requirements of subparagraph (B).
                    ``(D) Charitable research hospital.--A hospital 
                that is designated as a cancer center by the National 
                Cancer Institute.
                    ``(E) Other institutions.--A qualified organization 
                (as defined in section 41(e)(6)).
            ``(4) Exclusion for amounts funded by grants, etc.--The 
        term `eligible countermeasures research expenses' shall not 
        include any amount to the extent such amount is funded by any 
        grant, contract, or otherwise by another person (or any 
        governmental entity).
    ``(c) Countermeasures Research Base Period Amount.--For purposes of 
this section, the term `countermeasures research base period amount' 
means the average annual eligible countermeasures research expenses 
paid by the taxpayer during the 3-taxable year period ending with the 
taxable year immediately preceding the first taxable year of the 
taxpayer beginning after December 31, 2004.
    ``(d) Special Rules.--
            ``(1) Certain rules made applicable.--Rules similar to the 
        rules of subsections (f) and (g) of section 41 shall apply for 
        purposes of this section.
            ``(2) Coordination with credit for increasing research 
        expenditures and with credit for clinical testing expenses for 
        certain drugs for rare diseases.--Any eligible countermeasures 
        research expense for a taxable year shall not be taken into 
        account for purposes of determining the credit allowable under 
        section 41 or 45C for such taxable year.
            ``(3) Eligible countermeasures research expenses not 
        treated as unrelated business taxable income.--For purposes of 
        section 511, eligible countermeasures research expenses paid or 
        incurred by the taxpayer directly or indirectly to any 
        qualified non-profit or academic institution shall not be 
        considered unrelated business taxable income of such 
        institution.''.
                    (B) Credit to be part of general business credit.--
                Section 38(b) of such Code (relating to current year 
                business credits), as amended by this section, is 
                amended by striking ``plus'' at the end of paragraph 
                (19), by striking the period at the end of paragraph 
                (20) and inserting ``, plus'', and by adding at the end 
                the following:
            ``(21) the countermeasures research credit determined under 
        section 41A(a).''.
                    (C) Denial of double benefit.--Section 280C of such 
                Code, as amended by this section, is amended by adding 
                at the end the following new subsection:
    ``(f) Credit for Countermeasures Research Expenses.--
            ``(1) In general.--No deduction shall be allowed for that 
        portion of the eligible countermeasures research expenses (as 
        defined in section 41A(b)) otherwise allowable as a deduction 
        for the taxable year which is equal to the amount of the credit 
        determined for such taxable year under section 41A(a).
            ``(2) Certain rules to apply.--Rules similar to the rules 
        of paragraphs (2), (3), and (4) of subsection (c) shall apply 
        for purposes of this subsection.''.
                    (D) Deduction for unused portion of credit.--
                Section 196(c) of such Code (defining qualified 
                business credits), as amended by this section, is 
                amended by striking ``and'' at the end of paragraph 
                (12), by striking the period at the end of paragraph 
                (13) and inserting ``, and'', and by adding at the end 
                the following new paragraph:
            ``(14) the countermeasures research expenses credit 
        determined under section 41A(a) (other than such credit 
        determined under the rules of section 280C(f)(2)),''.
                    (E) Clerical amendment.--The table of sections for 
                subpart D of part IV of subchapter A of chapter 1 of 
                such Code is amended by adding after the item relating 
                to section 41 the following:

                              ``Sec. 41A. Credit for countermeasures 
                                        research expenses.''.
            (3) Countermeasures equity tax credit.--
                    (A) In general.--Subpart D of part IV of subchapter 
                A of chapter 1 of the Internal Revenue Code of 1986 
                (relating to business-related credits), as amended by 
                this section, is amended by adding at the end the 
                following new section:

``SEC. 45K. COUNTERMEASURES EQUITY TAX CREDIT.

    ``(a) Allowance of Credit.--
            ``(1) General rule.--For purposes of section 38, in the 
        case of a taxpayer who holds a qualified countermeasures equity 
        investment on a credit allowance date of such investment which 
        occurs during the taxable year, the countermeasures equity tax 
        credit determined under this section for such taxable year is 
        an amount equal to the applicable percentage of the amount paid 
        to the qualified countermeasures company solely in exchange for 
        its stock at original issue.
            ``(2) Applicable percentage.--For purposes of paragraph 
        (1), the applicable percentage is 40 percent.
            ``(3) Credit allowance date.--For purposes of paragraph 
        (1), the term `credit allowance date' means, with respect to 
        any qualified countermeasures equity investment--
                    ``(A) the date on which such investment is 
                initially made, and
                    ``(B) each of the 3 anniversary dates of such date 
                thereafter.
    ``(b) Qualified Countermeasures Equity Investment.--For purposes of 
this section--
            ``(1) In general.--The term `qualified countermeasures 
        equity investment' means any equity investment in a qualified 
        countermeasures company if--
                    ``(A) such investment is acquired by the taxpayer 
                at its original issue (directly or through an 
                underwriter) solely in exchange for cash,
                    ``(B) not less than \1/2\ of such cash is used by 
                the qualified countermeasures company with respect to 
                any contract described in section 311(a) of the Project 
                BioShield II Act of 2005 or efforts reasonably leading 
                to such contract (such as generation of preliminary 
                data or prototype development), and
                    ``(C) such investment is designated for purposes of 
                this section by the qualified countermeasures company.
        Such term shall not include any equity investment issued by a 
        qualified countermeasures company more than 5 years after the 
        date that such company receives an allocation under subsection 
        (d). Any allocation not used within such 5-year period may be 
        reallocated by the Secretary under subsection (d).
            ``(2) Limitation.--The maximum amount of equity investments 
        issued by a qualified countermeasures company which may be 
        designated under paragraph (1)(C) by such company shall not 
        exceed the portion of the limitation amount allocated under 
        subsection (f) to such company.
            ``(3) Treatment of subsequent purchasers.--The term 
        `qualified equity investment' includes any equity investment 
        which would (but for paragraph (1)(A)) be a qualified equity 
        investment in the hands of the taxpayer if such investment was 
        a qualified equity investment in the hands of a prior holder.
            ``(4) Redemptions.--A rule similar to the rule of section 
        1202(c)(3) shall apply for purposes of this subsection.
            ``(5) Equity investment.--The term `equity investment' 
        means any stock (other than nonqualified preferred stock as 
        defined in section 351(g)(2)) in an entity which is a 
        corporation.
    ``(c) Qualified Countermeasures Company.--For purposes of this 
section the term `qualified countermeasures company' means any domestic 
corporation subject to tax under subchapter C of this chapter if such 
company has entered into a procurement contract with the Secretary of 
Health and Human Services under section 319F-1 or 319F-2 of the Public 
Health Service Act (42 U.S.C. 247d-6a or 247d-6b) or with the Secretary 
of Homeland Security under section 512 of the Homeland Security Act of 
2002.
    ``(d) National Limitation on Amount of Investments Designated.--
            ``(1) In general.--There is a qualified countermeasures 
        equity tax credit limitation for each calendar year. Such 
        limitation is $100,000,000 for each calendar year 2005 through 
        2009.
            ``(2) Allocation of limitation.--The limitation under 
        paragraph (1) shall be allocated by the Secretary among 
        qualified countermeasures companies selected by the Secretary. 
        In making allocations under the preceding sentence, the 
        Secretary shall give priority to the extent to which it is 
        reasonably anticipated that a qualified countermeasures company 
        would have insufficient taxable income and tax liability to 
        utilize research tax credits and other tax incentives provided 
        by sections 311 and 312 of the Project BioShield II Act of 
        2005.
            ``(3) Carryover of unused limitation.--If the qualified 
        countermeasures equity tax credit limitation for any calendar 
        year exceeds the aggregate amount allocated under paragraph (2) 
        for such year, such limitation for the succeeding calendar year 
        shall be increased by the amount of such excess. No amount may 
        be carried under the preceding sentence to any calendar year 
        after 2014.
    ``(e) Recapture of Credit in Certain Cases.--
            ``(1) In general.--If, at any time during the 4-year period 
        beginning on the date of the original issue of a qualified 
        countermeasures equity investment in a qualified 
        countermeasures company, there is a recapture event with 
        respect to such investment, then the tax imposed by this 
        chapter for the taxable year in which such event occurs shall 
        be increased by the credit recapture amount.
            ``(2) Credit recapture amount.--For purposes of paragraph 
        (1), the credit recapture amount is an amount equal to the sum 
        of--
                    ``(A) the aggregate decrease in the credits allowed 
                to the taxpayer under section 38 for all prior taxable 
                years which would have resulted if no credit had been 
                determined under this section with respect to such 
                investment, plus
                    ``(B) interest at the underpayment rate established 
                under section 6621 on the amount determined under 
                subparagraph (A) for each prior taxable year for the 
                period beginning on the due date for filing the return 
                for the prior taxable year involved.
        No deduction shall be allowed under this chapter for interest 
        described in subparagraph (B).
            ``(3) Recapture event.--For purposes of paragraph (1), 
        there is a recapture event with respect to a qualified 
        countermeasures equity investment in a qualified 
        countermeasures company if--
                    ``(A) such company ceases to be a qualified 
                countermeasures company, or
                    ``(B) such investment is redeemed by such company.
            ``(4) Special rules.--
                    ``(A) Tax benefit rule.--The tax for the taxable 
                year shall be increased under paragraph (1) only with 
                respect to credits allowed by reason of this section 
                which were used to reduce tax liability. In the case of 
                credits not so used to reduce tax liability, the 
                carryforwards and carrybacks under section 39 shall be 
                appropriately adjusted.
                    ``(B) No credits against tax.--Any increase in tax 
                under this subsection shall not be treated as a tax 
                imposed by this chapter for purposes of determining the 
                amount of any credit under this chapter or for purposes 
                of section 55.
    ``(f) Basis Reduction.--The basis of any qualified countermeasures 
equity investment shall be reduced by the amount of any credit 
determined under this section with respect to such investment. This 
subsection shall not apply for purposes of sections 1202, 1400B, and 
1400F.
    ``(g) Regulations.--The Secretary shall prescribe such regulations 
as may be appropriate to carry out this section, including regulations 
which--
            ``(1) prevent the abuse of the purposes of this section,
            ``(2) impose appropriate reporting requirements, and
            ``(3) apply the provisions of this section to newly formed 
        entities.''.
                    (B) Credit to be part of general business credit.--
                Section 38(b) of such Code (relating to current year 
                business credits), as amended by this section, is 
                amended by striking ``plus'' at the end of paragraph 
                (20), by striking the period at the end of paragraph 
                (21) and inserting ``, plus'', and by adding at the end 
                the following:
            ``(22) the countermeasures equity investment credit 
        determined under section 45K(a).''.
                    (C) Deduction for unused portion of credit.--
                Section 196(c) of such Code (defining qualified 
                business credits), as amended by this section, is 
                amended by striking ``and'' at the end of paragraph 
                (13), by striking the period at the end of paragraph 
                (14) and inserting ``, and'', and by adding at the end 
                the following new paragraph:
            ``(15) the countermeasures equity investment credit 
        determined under section 45K(a),''.
                    (D) Clerical amendment.--The table of sections for 
                subpart D of part IV of subchapter A of chapter 1 of 
                such Code is amended by adding after the item relating 
                to section 41 the following:

                              ``Sec. 45K. Countermeasures equity tax 
                                        credit.''.
    (b) Effective Date.--The amendments made by this section shall 
apply to taxable years beginning after December 31, 2004.

                     Subtitle C--Patent Protections

SEC. 331. PATENT TERM RESTORATION AND EXTENSION AND EXCLUSIVE 
              MARKETING.

    (a) Limitation.--A private entity may utilize the patent term 
restoration and extension and exclusive marketing provisions described 
in this subtitle if such private entity--
            (1) is an entity described under section 301(b)(2);
            (2) has had an application for certification approved by 
        the Secretary of Health and Human Services or the Secretary of 
        Homeland Security, as appropriate, under section 301(b)(4)(C); 
        and
            (3)(A) has received approval of the countermeasure by the 
        Food and Drug Administration; or
            (B) section 319F-2(e) applies.
    (b) Restoration of Patent Terms Relating to Countermeasures.--
            (1) In general.--Chapter 14 of title 35, United States 
        Code, is amended by inserting after section 156 the following:
``Sec. 156a. Restoration of patent terms relating to countermeasure 
              products
    ``(a) Definitions.--In this section, the term--
            ``(1) `countermeasure product' means a countermeasure, as 
        that term is defined in section 319F-3(a)(2) of the Public 
        Health Service Act, that is a--
                    ``(A) new drug, antibiotic drug, or device, as 
                those terms are defined in section 201 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 321); or
                    ``(B) biological product, as such term is defined 
                in section 351 of the Public Health Service Act (42 
                U.S.C. 262);
            ``(2) `regulatory review period' means the period of time 
        that--
                    ``(A) starts on the date that is the later of--
                            ``(i) the date that an eligible patent 
                        sought to be extended under this section is 
                        filed;
                            ``(ii) if the countermeasure product is a 
                        drug, antibiotic drug, or biological product, 
                        the date that an exemption under section 505(i) 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355(i)) became effective for the 
                        product; or
                            ``(iii) if the countermeasure product is a 
                        device, the date that an investigational device 
                        exception is approved under section 520(g) of 
                        the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 360j(g)) became effective for the 
                        product; and
                    ``(B) ends on the date that is--
                            ``(i) in the case of a drug or antibiotic 
                        drug, the date on which an application 
                        submitted for the drug or antibiotic drug under 
                        section 505(b)(1) of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 355(b)(1)) is 
                        approved;
                            ``(ii) in the case of a biological product, 
                        the date on which an application submitted for 
                        the biological product under section 351 of the 
                        Public Health Service Act (42 U.S.C. 262) is 
                        approved;
                            ``(iii) in the case of a device, the date 
                        on which an application submitted for the 
                        device under section 513 of the Federal Food, 
                        Drug, and Cosmetic Act (21 U.S.C. 360c) is 
                        approved; or
                            ``(iv) if an application is submitted under 
                        subsection (c)(3) prior to any of the dates 
                        specified in clauses (i) through (iii), the 
                        date that the countermeasure product became 
                        eligible for purchase under a contract for 
                        procurement under section 319F-1 or 319F-2 of 
                        the Public Health Service Act (42 U.S.C. 247d-
                        6a or 247d-6b)) or under section 512 of the 
                        Homeland Security Act of 2002;
            ``(3) `eligible patent' means a patent that--
                    ``(A) claims a countermeasure product that has been 
                successfully developed as specified in section 
                301(b)(3) of the Research Act, or an active ingredient 
                of such product, or a process of making or method of 
                using such product or the active ingredient of such 
                product for the countermeasure use that has been 
                approved by the Food and Drug Administration; and
                    ``(B) is owned by, or licensed to, an entity that 
                has been certified as having successfully developed the 
                countermeasure section 301(b)(4)(C) of the Research 
                Act; and
            ``(4) `Research Act' means the Project BioShield II Act of 
        2005.
    ``(b) Patent Term Restoration.--The term of an eligible patent 
shall be restored by a period equal to the number of days in the 
regulatory review period if, with respect to the patent that is the 
basis of the application--
            ``(1) an application under subsection (c) is submitted to 
        the Director by either the owner of record of the patent, or 
        its agent, on or before the later of--
                    ``(A) the date specified in subsection (c)(3); or
                    ``(B) 45 days after the date of issuance of the 
                patent;
            ``(2) the patent has not been previously restored under 
        this section, or extended under section 156 or 158;
            ``(3) the term of the patent has not expired before the 
        date that the application is submitted to the Director; and
            ``(4) the regulatory review period for the countermeasure 
        product--
                    ``(A) has not been relied upon to support an 
                application to extend the term of another patent under 
                this section or under section 156; and
                    ``(B) did not commence before the date of enactment 
                of the Research Act.
    ``(c) Administrative Provisions.--
            ``(1) In general.--To obtain a restoration of the term of a 
        patent under this section, the owner of record of the patent or 
        the agent of the owner shall submit an application to the 
        Director.
            ``(2) Content.--The application shall contain--
                    ``(A) a description of the approved countermeasure 
                product and the Federal statute under which regulatory 
                review occurred;
                    ``(B) the identity of the patent for which a 
                restoration is sought; and
                    ``(C) such other information as the Director may 
                require.
            ``(3) Submission of application.--An application under this 
        section shall be submitted to the Director not later than 60 
        days after the last of the following dates:
                    ``(A) The date that the product became eligible for 
                purchase under a contract for procurement under section 
                319F-1 or 319F-2 of the Public Health Service Act (42 
                U.S.C. 247d-6a or 247d-6b)) or under section 512 of the 
                Homeland Security Act of 2002.
                    ``(B) The date that an application under section 
                505 of the Federal Food Drug and Cosmetic Act was 
                approved for the drug or antibiotic drug.
                    ``(C) The date that an application under section 
                351 of the Public Health Service Act was approved for 
                the biological product.
                    ``(D) The date that an application under section 
                513 of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 360c) was approved for the device.
            ``(4) Publication of applications by the secretary.--
        Immediately under receipt of an application for patent 
        restoration under this subsection, the Director shall publish 
        the application and provide a reasonable period of time for 
        interested parties to submit comments with respect to the 
        application.
            ``(5) Irrevocable election.--The submission of an 
        application under this section is an irrevocable election of 
        the application of this section to the patent that is the basis 
        of the application. A patent that has been the basis of an 
        application made under this section may not be the subject of 
        an application made under section 156 or 158.
    ``(d) Limitations.--A patent that is the subject of an application 
filed under subsection (c) may not be restored under this section if--
            ``(1) the regulatory review period for the countermeasure 
        product was commenced before the date of enactment of the 
        Research Act;
            ``(2) the patent that is the basis of the application under 
        this section expired before the date of enactment of the 
        Research Act; or
            ``(3) a patent which has been extended under section 156 of 
        this title prior to the date of enactment of the Research Act 
        claims the countermeasure product, an active ingredient of the 
        countermeasure product, a method of using the countermeasure 
        product, a method of using an active ingredient of the 
        countermeasure product, or making the countermeasure.''.
            (2) Technical and conforming amendment.--The table of 
        sections for chapter 14 of title 35, United States Code, is 
        amended by inserting after the item relating to section 156 the 
        following:

        ``156a. Restoration of patent terms relating to countermeasure 
                            products.''.
    (c) Extension of Patent Terms Relating to Countermeasure 
Products.--
            (1) In general.--Chapter 14 of title 35, United States 
        Code, is amended by adding at the end the following:
``Sec. 158. Extension of patent terms relating to countermeasure 
              products
    ``(a) Definitions.--In this section, the term--
            ``(1) `countermeasure product' means a countermeasure, as 
        that term is defined in 319F-3(a)(2) of the Public Health 
        Service Act, that is a--
                    ``(A) new drug or antibiotic drug, as those terms 
                are defined in section 201 in the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 321), containing an active 
                ingredient (including any ester or salt of the active 
                ingredient) which has not been approved in another 
                application under section 505(b) of that Act (21 U.S.C. 
                355(b));
                    ``(B) device, as that term is defined in section 
                201 in the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 321); or
                    ``(C) biological product, as that term is defined 
                in section 351 of the Public Health Service Act (42 
                U.S.C. 262);
            ``(2) `designated product' means a drug, antibiotic drug, 
        or device, as those terms are defined in section 201 of the 
        Federal Food, Drug and Cosmetic Act (21 U.S.C. 321), or a 
        biological product, as that term is defined in section 351 of 
        the Public Health Service Act;
            ``(3) `eligible patent' means a patent that at the time the 
        eligible entity entered into the contract to develop such 
        countermeasure product, was owned by or licensed to that 
        eligible entity, and claims a designated product, an active 
        ingredient of a designated product, a method of making or using 
        a designated product or a method of making or using an active 
        ingredient of a designated product;
            ``(4) `eligible entity' means a natural or legal person 
        that has--
                    ``(A) successfully developed a countermeasure 
                product;
                    ``(B) been certified as being eligible to receive a 
                patent term extension under this section by section 
                301(b)(4)(A)(i) of the Research Act;
                    ``(C) been certified as having successfully 
                developed a countermeasure under section 301(b)(4)(C) 
                of the Research Act; and
                    ``(D) entered into a contract for the sale of the 
                countermeasure product under section 319F-1 or 319F-2 
                of the Public Health Service Act (42 U.S.C. 247d-6a or 
                247d-6b) or section 512 of the Homeland Security Act of 
                2002; and
            ``(5) `Research Act' means the Project BioShield II Act of 
        2005.
    ``(b) Patent Term Extension.--The term of an eligible patent shall 
be extended for the period determined by the Secretary of Health and 
Human Services in a certification under section 301(b)(4)(A)(i) of the 
Research Act, in addition to the term which would otherwise apply 
except for this section, if--
            ``(1) an application under subsection (c) is submitted to 
        the Director by either the owner of record of the patent or its 
        agent on or before the date specified in subsection (c)(3);
            ``(2) the patent has not been previously extended under 
        this section, or under section 156 or 156a;
            ``(3) the applicant has provided written notice and the 
        Secretary has published such information as required under 
        section 301(b)(4)(B) of the Project BioShield II Act of 2005;
            ``(4) the patent has not expired before the date that the 
        application is submitted;
            ``(5) the term of no other patent has been extended based 
        on the certification being relied upon by the eligible entity 
        to request extension of the patent; and
            ``(6) no other patent that claims the designated product, 
        an active ingredient of the designated product, a method of 
        making or using a designated product or a method of making or 
        using an active ingredient of a designated product has been 
        extended under this section or under section 156a.
    ``(c) Administrative Provisions.--
            ``(1) In general.--To obtain an extension of the term of a 
        patent under this section, the owner of record of the patent or 
        the agent of the owner shall submit an application to the 
        Director.
            ``(2) Content.--An application filed under this section 
        shall contain--
                    ``(A) a description of the approved countermeasure 
                product and the Federal statute under which regulatory 
                review occurred;
                    ``(B) the identity of the eligible patent for which 
                an extension is sought under this section;
                    ``(C) the identity of the eligible entity and the 
                applicant (if different from the eligible entity);
                    ``(D) the identity of the designated product to 
                which the eligible patent relates;
                    ``(E) information concerning the certification 
                specified in section 301(b)(4)(A)(i) of the Research 
                Act being relied upon as the basis of the extension 
                being requested;
                    ``(F) information indicating that the entity owned 
                or licensed the eligible patent at the time it entered 
                into the contract to develop the countermeaure product; 
                and
                    ``(G) such other information as the Director may 
                require including to establish that the applicant meets 
                the requirements of this section.
            ``(3) Submission of application.--An application under this 
        section shall be submitted to the Director within 60 days after 
        the date of the certification specified in section 301(b)(4)(C) 
        of the Research Act that is being relied upon to request 
        extension of the patent that is the subject of the application.
    ``(d) Irrevocable Election.--The submission of an application under 
this section is an irrevocable election of the application of this 
section to the patent that is the basis of the application. A patent 
that has been the basis of an application made under this section may 
not be the subject of an application made under sections 156 or 
156a.''.
            (2) Technical and conforming amendment.--The table of 
        sections for chapter 14 of title 35, United States Code, is 
        amended by adding at the end the following:

``158. Extension of patent terms relating to countermeasure 
                            products.''.
    (d) Discretionary Waiver of March-In Rights and Exclusive 
Licensing.--
            (1) Discretion to waive march-in rights.--
                    (A) In general.--The owner of a patent over which 
                the Government has rights under chapter 18 of title 35, 
                United States Code, may request that a Federal agency 
                under whose funding a subject invention was made may 
                waive rights the Government has under sections 200, 
                203, and 209 of title 35, United States Code, if--
                            (i) such entity holds a certification under 
                        section 301(b)(4)(C) of the Research Act; and
                            (ii) the subject invention is related to or 
                        will be used to discover, evaluate, produce, 
                        manufacture or use the countermeasure, 
                        detection equipment, diagnostic, research tool, 
                        drug, antibiotic drug, biological product or a 
                        device that is the subject of the 
                        certification.
                    (B) Requests.--If a request under subparagraph (A) 
                is made within 90 days after the date of the 
                certification under section 301(b)(4)(C) of the 
                Research Act or the date that the entity obtained title 
                to the patent, the Federal agency shall grant the 
                request.
            (2) Federally owned inventions.--Section 209 of title 35, 
        United States Code, is amended--
                    (A) by redesignating subsections (e) and (f) as 
                subsections (f) and (g), respectively; and
                    (B) by inserting after subsection (d) the 
                following:
    ``(e) Terms and Conditions of Exclusive License.--Each exclusive 
license granted under section 207(a)(2) shall include a provision that, 
at the discretion of the licensee, the licensee may act as the agent 
for the licensor with respect to any patent for the licensed invention 
for purposes of extending a patent under section 156a or 158.''.
            (3) Cooperative research and development agreements.--
        Section 12(b) of the Stevenson-Wydler Technology Innovation Act 
        of 1980 (15 U.S.C. 3710a(b)) is amended by adding at the end 
        the following:
            ``(7) Each exclusive license for a patent granted under an 
        agreement entered into under subsection (a)(1) shall include a 
        provision that, at the discretion of the licensee, the licensee 
        may act as the agent for the licensor with respect to that 
        patent for purposes of extending a patent under section 156a or 
        158 of title 35, United States Code.''.
            (4) Applicable licenses.--The amendments made by paragraphs 
        (2) and (3) shall apply only to exclusive licenses granted 
        after 60 days after the date of enactment of this Act.
    (e) Exclusive Marketing.--Subchapter A of chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
inserting after section 505B, the following:

``SEC. 505C. MARKET EXCLUSIVITY FOR COUNTERMEASURE PRODUCTS.

    ``(a) In General.--Subsection (b) shall apply if the Secretary 
determines that a new drug is a countermeasure product, as that term is 
defined in section 156a(a)(1) of title 35, United States Code, that has 
been successfully developed by an entity that has been certified under 
section 301(b)(4)(A) of the Project BioShield II Act of 2005.
    ``(b) Exclusivity.--With respect to a new drug described in 
subsection (a)--
            ``(1)(A)(i) the period referred to in subsection 
        (c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii) 
        of such section, shall be 10 years instead of 5 years, and the 
        periods of 4 years, to 48 months, and to 7 and one-half years 
        referred to in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of 
        such section shall be 9 years, 108 months, and 9 years, 
        respectively; or
            ``(ii) the period referred to in clauses (iii) and (iv) of 
        subsection (c)(3)(E) of such section, and in clauses (iii) and 
        (iv) of subsection (j)(5)(F) of such section, shall be 6 years 
        instead of 3 years; and
            ``(B) if the drug is designated under section 526 for a 
        rare disease or condition, the period referred to in section 
        527(a) shall be 10 years instead of 7 years.
    ``(c) Special Rule for Unexploited Countermeasures.--If, as of the 
date that is 45 days before the date on which the periods specified in 
paragraph (1) or (2) of section 505B expire, there has been no 
substantial commercial exploitation of the drug, including 
insubstantial sales of the drug following its approval for marketing, 
the periods specified in such sections shall be extended by a period of 
3 years.''.

SEC. 332. INTERNATIONAL PROTECTION FOR BIOSHIELD INTELLECTUAL PROPERTY.

    The Secretary of Commerce, the United States Trade Representative, 
and the Commissioner of Patents shall ensure in international, 
bilateral, and multilateral negotiations and agreements, and 
proceedings before agencies of the World Trade Organization, that--
            (1) intellectual property for which restoration of a patent 
        term is granted under section 156a of title 35, United States 
        Code (as added by section 331), or for which an extension of a 
        patent term is granted under section 158 of title 35, United 
        States Code, (as added by section 331) under this Act is not 
        impaired;
            (2) substantially similar intellectual property rights 
        granted to the same or related entities as those that qualify 
        for restoration or an extension under such sections are not 
        impaired; and
            (3) vigorous enforcement actions and sanctions are taken 
        and imposed with respect to infringement of such intellectual 
        property.

                   Subtitle D--Liability Protections

SEC. 341. LIABILITY AND COMPENSATION FOR INJURED PARTIES.

    (a) The Public Health Service Act Amendments.--Section 224 of the 
Public Health Service Act (42 U.S.C. 233) is amended--
            (1) in subsection (a), by inserting ``or the manufacture or 
        distribution of a covered countermeasure as defined in 
        subsection (p)'' after ``including the conduct of clinical 
        studies or investigation'';
            (2) in the heading of subsection (p), by striking 
        ``Administration of Smallpox Countermeasures by Health 
        Professionals'' and inserting ``Manufacture, Distribution, and 
        Administration of Covered Countermeasures'';
            (3) in subsection (p)(1)--
                    (A) by inserting ``manufacture, distribution, or'' 
                after ``liability arising out of'';
                    (B) by striking ``against smallpox to an 
                individual''; and
                    (C) by inserting before the period at the end 
                ``notwithstanding the applicability of the SAFETY Act 
                (6 U.S.C. 441 et seq.)'';
            (4) in subsection (p)(2)--
                    (A) in the heading, by striking ``countermeasure 
                against smallpox'' and inserting ``covered 
                countermeasures'';
                    (B) in subparagraph (A)(i)--
                            (i) by inserting ``(I)'' after ``makes 
                        advisable''; and
                            (ii) by inserting before the period at the 
                        end ``; or (II) the manufacture or distribution 
                        of a covered countermeasure for possible future 
                        administration to a category or categories of 
                        individuals'';
                    (C) in subparagraph (A)(ii) by inserting--
                            (i) ``, or product or products'' after ``or 
                        substances''; and
                            (ii) before the period at the end ``and any 
                        conditions governing the manufacture or 
                        distribution of such covered countermeasures'';
                    (D) in subparagraph (A)(iv), by adding at the end 
                before the period ``. Notwithstanding clause (iii), 
                such declaration or amendment shall take effect 
                immediately upon publication and shall not be subject 
                to the provisions of section 553 of title 5, United 
                States code, concerning prior notice and opportunity 
                for comment''.
                    (E) in subparagraph (A), by adding at the end the 
                following:
                    ``(v) Recommended declaration.--Any person may 
                recommend to the Secretary at any time the declaration 
                of a countermeasure under this paragraph and may 
                provide data and information to support such 
                recommendation.'';
                    (F) in subparagraph (B)(i), by striking ``, for a 
                purpose stated in paragraph (7)(A)(i),''; and
                    (G) by adding at the end the following:
                    ``(E) Liability of the united states.--The United 
                States shall be liable under this subsection with 
                respect to a claim arising out of the manufacture, 
                distribution, or administration of a covered 
                countermeasure regardless of whether--
                            ``(i) the cause of action seeking 
                        compensation for harm caused by such 
                        countermeasure is alleged as negligence, strict 
                        liability, breach of warranty, failure to warn, 
                        or other action; or
                            ``(ii) the covered countermeasure is 
                        designated or certified as a qualified anti-
                        terrorism technology under the SAFETY Act (6 
                        U.S.C. 441 et seq.).
                The United States shall be liable under this subsection 
                for claims for injury or loss arising out of 
                administration of a covered countermeausre during a 
                human clinical investigation on a covered 
                countermeasure whether or not the certification for 
                successful development of the countermeausre is made 
                under section 301(b)(3) of the Project BioShield II Act 
                of 2005.
                    ``(F) Liability of the united states for 
                manufacture or distribution within the scope of 
                declaration.--
                            ``(i) In general.--Except as provided in 
                        paragraph (5)(B)(ii), the United States shall 
                        be liable under this subsection with respect to 
                        a claim arising out of the manufacture or 
                        distribution of a covered countermeasure if--
                                    ``(I) the manufacturer was covered 
                                by a declaration by the Secretary under 
                                subparagraph (A) with respect to such 
                                countermeasure; and
                                    ``(II) the countermeasure was 
                                manufactured and distributed in 
                                accordance with, and during, the 
                                relevant period of such declaration.
                            ``(ii) Effect of section.--For purposes of 
                        this section, any activity reasonably related 
                        to the manufacture, distribution, or 
                        administration of a covered countermeasure 
                        shall be considered to be a medical, surgical, 
                        dental, or related function within the scope of 
                        the covered person's employment by the Public 
                        Health Service.'';
            (5) in subsection (p)(4)(A), by inserting ``manufacture, 
        distribution, or'' after ``arising out of the''; and
            (6) in subsection (p)(7)--
                    (A) by striking subparagraph (A) and inserting the 
                following:
                    ``(A) Covered countermeasure.--
                            ``(i) Before publication of list.--Until 
                        the date that the Secretary publishes the list 
                        described under section 319F-3(f), the term 
                        ``covered countermeasure'' means a substance or 
                        product that is specified in a declaration 
                        under paragraph (2).
                            ``(ii) After publication of list. After the 
                        date that the Secretary publishes the list 
                        described under section 319F-3(f), the term 
                        ``covered countermeasure'' means a substance or 
                        product that is--
                                    ``(I) specified in a declaration 
                                under paragraph (2); and
                                    ``(II)(aa) a countermeasure, as 
                                such term is defined is section 319F-3; 
                                or
                                    ``(bb) designed, developed, 
                                modified, used, or procured for the 
                                purpose of preventing, detecting, 
                                identifying, or treating pandemic 
                                influenza or limiting the harm such 
                                influenza might otherwise cause.'';
                    (B) in subparagraph (B)--
                            (i) in the matter preceding clause (i), by 
                        inserting ``manufacture, distribution, or'' 
                        after ``with respect to the''; and
                            (ii) in clause (iv), by inserting ``or 
                        distribution'' after ``with respect to 
                        administration''; and
                    (C) in subparagraph (D)--
                            (i) in the heading, by inserting 
                        ``manufacture, distribution, or'' after 
                        ``arising out of'';
                            (ii) in the matter preceding clause (i) 
                        by--
                                    (I) striking ``administration of a 
                                covered countermeasure''; and
                                    (II) by inserting ``relating to the 
                                manufacture, distribution, or 
                                administration of a covered 
                                countermeasure'' after ``with respect 
                                to a claim or liability'';
                            (iii) in clause (iii), by striking ``; or'' 
                        and inserting a semicolon;
                            (iv) in clause (iv) by striking the period 
                        and inserting ``; or''; and
                            (v) by adding at the end the following:
                            ``(v) the manufacture or distribution of a 
                        covered countermeasure and administration of a 
                        covered countermeasure in the course of a human 
                        clinical investigation.
                        For purposes of this subsection, the term 
                        `administration' includes administration in the 
                        course of a human clinical investigation.''.
    (b) Amendments to the SAFETY Act.--The SAFETY Act (6 U.S.C. 441 et 
seq.) is amended--
            (1) in section 863, in subsections (a)(1), (a)(2), (d)(1), 
        and (d)(2), by inserting ``, or potential threat of such act,'' 
        after ``from such act'';
            (2) in section 864--
                    (A) in subsections (a)(1), (b), and (c), by 
                inserting ``or potential threat of such act'' after 
                ``from such act''; and
                    (B) in subsection (a)(3), by inserting ``or 
                potential threat of such act'' after ``act of 
                terrorism''; and
            (3) in section 865(1)--
                    (A) by inserting ``(including a vaccine, 
                therapeutic or other biological product, drug, 
                antimicrobial or combination thereof, detection 
                technology, or device)'' after ``product'';
                    (B) by inserting ``, biotechnology, detection 
                technology, or a pharmacological product'' after 
                ``information technology''; and
                    (C) by inserting ``treating,'' after 
                ``preventing,''.
    (c) Limitation.--A private entity may utilize the liability 
protections described in this section (and the amendments made by this 
section) if such entity--
            (1)(A) is described under section 301(b)(2); and
            (B) has been certified by the Secretary of Health and Human 
        Services or the Secretary of Homeland Security, as appropriate, 
        under section 301(b)(4); or
            (2) without regard to the requirements of sections 
        301(b)(2) and 301(b)(4), has developed a product (including a 
        drug, vaccine, or other biologic), equipment, service 
        (including support service), device, or technology (including 
        information technology) designed, developed, modified, used, or 
        procured for the specific purpose of preventing, detecting, 
        identifying, or treating pandemic influenza or limiting the 
        harm such pandemic might cause.
    (d) Effect of Section.--Notwithstanding any other provision of law, 
an entity shall not be required to apply for and receive designation or 
certification by the Secretary of Homeland Security of a product or 
service as a Qualified Anti-Terror Technology under the SAFETY Act (6 
U.S.C. 441 et seq.) in order to receive indemnification under Public 
Law 85-804.
    (e) Effect on Pending Actions.--Nothing in this Act (or the 
amendments made by this Act) shall be construed to apply to a legal 
action pending or filed on or before the date of enactment of this Act 
against a manufacturer or other entity with respect to a diagnostic, 
therapeutic, detection technology, or research that was not conducted 
pursuant to a contract under the amendments made by this Act or the 
Project BioShield Act of 2004 (Public Law 108-276).

             TITLE IV--VALLEY OF DEATH FOR SMALL COMPANIES

SEC. 401. PURPOSE.

    It is the purpose of this title to enable small companies to fund 
the initial research and development necessary so that such small 
companies may be able to participate in the procurement process for 
countermeasures, and become part of a national biodefense, infectious 
disease, and research tool industry.

SEC. 402. VALLEY OF DEATH FOR SMALL COMPANIES.

    Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-
6b), as amended by section 103, is amended by--
            (1) redesignating subsections (l) and (m) as subsections 
        (r) and (s), respectively; and
            (2) inserting after subsection (k) the following:
    ``(l) Reimbursement.--The Secretary may reimburse an entity for 
costs associated with improvement, increase, or production of a 
countermeasure necessary for testing (including a clinical trial) 
conducted on humans or animals from funds appropriated to fund the 
Project BioShield Act of 2004 and the Project BioShield II Act of 2005.
    ``(m) Grants to Certain Entities.--The Secretary may award grants 
to State or local government agencies, small businesses, university 
technology partnership offices, and other entities to conduct 
preliminary screening of compounds and to develop of business plans 
related to such preliminary screenings.
    ``(n) Security Funding.--The Secretary shall provide funding for an 
entity that enters into an agreement under the amendments made by the 
Project BioShield Act of 2004 or the Project BioShield II Act of 2005 
(and the amendments made by such Act) to provide security for the 
personnel and facilities of such entity that develop, produce, 
distribute, or store countermeasures under section 319K.
    ``(o) Priority Access to Certain Research Results.--An entity that 
enters into an agreement under this section, section 319F-2, or section 
512 of the Homeland Security Act of 2002 shall be given priority access 
to the results of research related to the epidemiology and pathogenesis 
of agents, the genomes and other DNA analysis, or other comparative 
analysis of agents relevant to research conducted under subparagraphs 
(A), (B), and (C) of section 319F(h)(1).
    ``(p) Translational Development for Biodefense Drug and Vaccine 
Candidates.--
            ``(1) In general.--An entity that enters into an agreement 
        under this section, section 319F-2, or section 512 of the 
        Homeland Security Act of 2002 shall be eligible for 
        translational development for biodefense drug and infectious 
        disease countermeasure candidates. For purposes of this 
        section, such entities may include universities, small 
        businesses, for-profit, and nonprofit entities.
            ``(2) Translational development.--In this subsection, the 
        term `translational development' shall include the following:
                    ``(A) Triage screening of applications for 
                promising drug and biological candidates.
                    ``(B) Plans to outline the tasks, timelines, and 
                costs required to complete the development process for 
                promising drug and biological candidates.
                    ``(C) Implementation of the recommended development 
                steps for key therapeutics.
                    ``(D) Project management to implement the 
                recommended development steps.
                    ``(E) Regulatory consultants to interface with the 
                Food and Drug Administration and the entity to devise a 
                plan that rapidly brings new biodefense candidates to 
                approval and stockpiling.
    ``(q) Rule of Construction.--Nothing in this section shall be 
construed to limit the authority of the Secretary or the Secretary of 
Homeland Security to distribute countermeasures from the Strategic 
National Stockpile to foreign countries or foreign entities if it is 
determined by such Secretaries that such a deployment would protect the 
interests and safety of citizens of the United States, living in the 
United States or abroad, from the event of a bioterrorist attack or 
other public health emergency.''.

                 TITLE V--BIOSHIELD ANTITRUST EXEMPTION

SEC. 501. LIMITED ANTITRUST EXEMPTION.

    Section 2 of the Clayton Act (15 U.S.C. 13) is amended by adding at 
the end the following:
    ``(g) Limited Antitrust Exemption.--
            ``(1) Countermeasures development meetings.--
                    ``(A) Countermeasures development meetings and 
                consultations.--The Secretary may conduct meetings and 
                consultations with parties involved in the development 
                of countermeasures for the purpose of the development, 
                manufacture, distribution, purchase, or sale of 
                countermeasures consistent with the purposes of this 
                title. The Secretary shall give notice of such meetings 
                and consultations to the Attorney General and the 
Chairperson of the Federal Trade Commission (referred to in this 
subsection as the `Chairperson').
                    ``(B) Meeting and consultation conditions.--A 
                meeting or consultation conducted under subparagraph 
                (A) shall--
                            ``(i) be chaired or, in the case of a 
                        consultation, facilitated by the Secretary;
                            ``(ii) be open to parties involved in the 
                        development, manufacture, distribution, 
                        purchase, or sale of countermeasures, as 
                        determined by the Secretary;
                            ``(iii) be open to the Attorney General and 
                        the Chairperson;
                            ``(iv) be limited to discussions involving 
                        the development, manufacture, distribution, or 
                        sale of countermeasures, consistent with the 
                        purposes of this title; and
                            ``(v) be conducted in such manner as to 
                        ensure that national security, confidential, 
                        and proprietary information is not disclosed 
                        outside the meeting or consultation.
                    ``(C) Minutes.--The Secretary shall maintain 
                minutes of meetings and consultations under this 
                subsection, which shall not be disclosed under section 
                552 of title 5, United States Code.
                    ``(D) Exemption.--The antitrust laws shall not 
                apply to meetings and consultations under this 
                paragraph, except that any agreement or conduct that 
                results from a meeting or consultation and that does 
                not receive an exemption pursuant to this subsection 
                shall be subject to the antitrust laws.
            ``(2) Written agreements.--The Secretary shall file a 
        written agreement regarding covered activities, made pursuant 
        to meetings or consultations conducted under paragraph (1) and 
        that is consistent with this paragraph, with the Attorney 
        General and the Chairperson for a determination of the 
        compliance of such agreement with antitrust laws. In addition 
        to the proposed agreement itself, any such filing shall 
        include--
                    ``(A) an explanation of the intended purpose of the 
                agreement;
                    ``(B) a specific statement of the substance of the 
                agreement;
                    ``(C) a description of the methods that will be 
                utilized to achieve the objectives of the agreement;
                    ``(D) an explanation of the necessity of a 
                cooperative effort among the particular participating 
                parties to achieve the objectives of the agreement; and
                    ``(E) any other relevant information determined 
                necessary by the Secretary in consultation with the 
                Attorney General and the Chairperson.
            ``(3) Determination.--The Attorney General, in consultation 
        with the Chairperson, shall determine whether an agreement 
        regarding covered activities referred to in paragraph (2) would 
        likely--
                    ``(A) be in compliance with the antitrust laws, and 
                so inform the Secretary and the participating parties; 
                or
                    ``(B) violate the antitrust laws, in which case, 
                the filing shall be deemed to be a request for an 
                exemption from the antitrust laws, limited to the 
                performance of the agreement consistent with the 
                purposes of this title.
            ``(4) Action on request for exemption.--
                    ``(A) In general.--The Attorney General, in 
                consultation with the Chairperson, shall grant, deny, 
                grant in part and deny in part, or propose 
                modifications to a request for exemption from the 
                antitrust laws under paragraph (3) within 15 days of 
                the receipt of such request.
                    ``(B) Extension.--The Attorney General may extend 
                the 15-day period referred to in subparagraph (A) for 
                an additional period of not to exceed 10 days. Such 
                additional period may be further extended only by the 
                United States district court, upon an application by 
                the Attorney General after notice to the Secretary and 
                the parties involved.
                    ``(C) Determination.--In granting an exemption 
                under this paragraph, the Attorney General, in 
                consultation with the Chairperson and the Secretary--
                            ``(i) must find--
                                    ``(I) that the agreement involved 
                                is necessary to ensure the availability 
                                of countermeasures;
                                    ``(II) that the exemption from the 
                                antitrust laws would promote the public 
                                interest; and
                                    ``(III) that there is no 
                                substantial competitive impact to areas 
                                not directly related to the purposes of 
                                the agreement; and
                            ``(ii) may consider any other factors 
                        determined relevant by the Attorney General and 
                        the Chairperson.
            ``(5) Limitation on and renewal of exemptions.--An 
        exemption granted under paragraph (4) shall be limited to 
        covered activities, and shall expire on the date that is 3 
        years after the date on which the exemption becomes effective 
        (and at 3-year intervals thereafter, if renewed) unless the 
        Attorney General in consultation with the Chairperson 
        determines that the exemption should be renewed (with 
        modifications, as appropriate) considering the factors 
        described in paragraph (4).
            ``(6) Limitation on parties.--The use of any information 
        acquired under an exempted agreement by the parties to such an 
        agreement for any purposes other than those specified in the 
        antitrust exemption granted by the Attorney General shall be 
        subject to the antitrust laws and any other applicable laws.
            ``(7) Guidelines.--The Attorney General and the Chairperson 
        may develop and issue guidelines to implement this subsection.
            ``(8) Report.--Not later than 1 year after the date of 
        enactment of the Project BioShield II Act of 2005, and annually 
        thereafter, the Attorney General and the Chairperson shall 
        report to Congress on the use and continuing need for the 
        exemption from the antitrust laws provided by this subsection.
            ``(9) Sunset.--The authority of the Attorney General to 
        grant or renew a limited antitrust exemption under this 
        subsection shall expire at the end of the 10-year period that 
        begins on the date of enactment of the Project BioShield II Act 
        of 2005.
    ``(h) Definitions.--In this section:
            ``(1) Antitrust laws.--The term `antitrust laws'--
                    ``(A) has the meaning given such term in subsection 
                (a) of the first section of the Clayton Act (15 U.S.C. 
                12(a)), except that such term includes the Act of June 
                19, 1936 (15 U.S.C. 13 et seq.) commonly known as the 
                Robinson-Patman Act), and section 5 of the Federal 
                Trade Commission Act (15 U.S.C. 45) to the extent such 
                section 5 applies to unfair methods of competition; and
                    ``(B) includes any State law similar to the laws 
                referred to in subparagraph (A).
            ``(2) Countermeasure.--The term `countermeasure' has the 
        meaning given that term in section 319F-3 of the Public Health 
        Service Act.
            ``(3) Covered activities.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), the term `covered activities' means 
                any group of activities or conduct, including 
                attempting to make, making, or performing a contract or 
                agreement or engaging in other conduct, for the purpose 
                of--
                            ``(i) theoretical analysis, 
                        experimentation, or the systematic study of 
                        phenomena or observable facts necessary to the 
                        development of countermeasures;
                            ``(ii) the development or testing of basic 
                        engineering techniques necessary to the 
                        development of countermeasures;
                            ``(iii) the extension of investigative 
                        findings or theory of a scientific or technical 
                        nature into practical application for 
                        experimental and demonstration purposes, 
                        including the experimental production and 
                        testing of models, prototypes, equipment, 
                        materials, and processes necessary to the 
                        development of countermeasures;
                            ``(iv) the production, distribution, or 
                        marketing of a product, process, or service 
                        that is a countermeasures;
                            ``(v) the testing in connection with the 
                        production of a product, process, or services 
                        necessary to the development of 
                        countermeasures;
                            ``(vi) the collection, exchange, and 
                        analysis of research or production information 
                        necessary to the development of 
                        countermeasures; or
                            ``(vii) any combination of the purposes 
                        described in clauses (i) through (vi);
                and such term may include the establishment and 
                operation of facilities for the conduct of covered 
                activities described in clauses (i) through (vi), the 
                conduct of such covered activities on a protracted and 
                proprietary basis, and the processing of applications 
                for patents and the granting of licenses for the 
                results of such covered activities.
                    ``(B) Exception.--The term `covered activities' 
                shall not include the following activities involving 2 
                or more persons:
                            ``(i) Exchanging information among 
                        competitors relating to costs, sales, 
                        profitability, prices, marketing, or 
                        distribution of any product, process, or 
                        service if such information is not reasonably 
                        necessary to carry out the purposes of covered 
                        activities.
                            ``(ii) Entering into any agreement or 
                        engaging in any other conduct--
                                    ``(I) to restrict or require the 
                                sale, licensing, or sharing of 
                                inventions, developments, products, 
                                processes, or services not developed 
                                through, produced by, or distributed or 
                                sold through such covered activities; 
                                or
                                    ``(II) to restrict or require 
                                participation by any person who is a 
                                party to such covered activities in 
                                other research and development 
                                activities, that is not reasonably 
                                necessary to prevent the 
                                misappropriation of proprietary 
                                information contributed by any person 
                                who is a party to such covered 
                                activities or of the results of such 
                                covered activities.
                            ``(iii) Entering into any agreement or 
                        engaging in any other conduct allocating a 
                        market with a competitor that is not expressly 
                        exempted from the antitrust laws by a 
                        determination under subsection (i)(4).
                            ``(iv) Exchanging information among 
                        competitors relating to production (other than 
                        production by such covered activities) of a 
                        product, process, or service if such 
                        information is not reasonably necessary to 
                        carry out the purpose of such covered 
                        activities.
                            ``(v) Entering into any agreement or 
                        engaging in any other conduct restricting, 
                        requiring, or otherwise involving the 
                        production of a product, process, or service 
                        that is not so expressly exempted from the 
                        antitrust laws by a determination under 
                        subsection (i)(4).
                            ``(vi) Except as otherwise provided in this 
                        subsection, entering into any agreement or 
                        engaging in any other conduct to restrict or 
                        require participation by any person who is a 
                        party to such activities, in any unilateral or 
                        joint activity that is not reasonably necessary 
                        to carry out the purpose of such covered 
                        activities.
            ``(4) Development.--The term `development' includes the 
        identification of suitable compounds or biological materials, 
        the conduct of preclinical and clinical studies, the 
        preparation of an application for marketing approval, and any 
        other actions related to preparation of a countermeasure.
            ``(5) Person.--The term `person' has the meaning given such 
        term in subsection (a) of the first section of this Act.
            ``(6) Secretary.--The term `Secretary' means the Secretary 
        of Health and Human Services.''.

                TITLE VI--BIOSHIELD IMMIGRATION PRIORITY

SEC. 601. H1B VISA EXEMPTION.

    Section 214(g) of the Immigration and Nationality Act (8 U.S.C. 
1184(g)) is amended by adding at the end the following new paragraph:
    ``(9)(A) The numerical limitations contained in paragraph (1)(A) 
shall not apply to any nonimmigrant alien issued a visa or otherwise 
provided status under section 101(a)(15)(H)(i)(b) who--
            ``(i) is employed by a person that has entered into a 
        contract for procurement with the Secretary of Health and Human 
        Services under the authority provided in section 319F-1 or 
        319F-2 of the Public Health Service Act (42 U.S.C. 247d-6a and 
        247d-6b) or with the Secretary of Homeland Security under 
        section 512 of the Homeland Security Act of 2002; and
            ``(ii) provides services related to the research, 
        development, or production of a qualified countermeasure or a 
        security countermeasure under such contract.
    ``(B) In this paragraph:
            ``(i) The term `qualified countermeasure' has the meaning 
        given that term in section 319F-1 of the Public Health Service 
        Act.
            ``(ii) The term `security countermeasure' has the meaning 
        given that term in section 319F-2 of the Public Health Service 
        Act.''.

SEC. 602. VISA PROCESSING.

    (a) Requirement To Expedite.--The Secretary of Homeland Security 
and the Secretary of State shall expedite the processing of an 
application of an alien seeking a visa under section 
101(a)(15)(H)(i)(b) of the Immigration and Nationality Act (8 U.S.C. 
1101(a)(15)(H)(i)(b)) if such alien--
            (1) is employed by a person that has entered into a 
        contract for procurement with the Secretary of Health and Human 
        Services under the authority provided in section 319F-1 or 
        319F-2 of the Public Health Service Act (42 U.S.C. 247d-6a and 
        247d-6b) or with the Secretary of Homeland Security under 
        section 512 of the Homeland Security Act of 2002; and
            (2) provides services related to the research, development, 
        or production of a qualified countermeasure or a security 
        countermeasure under such contract.
    (b) Definitions.--In this section:
            (1) Qualified countermeasure.--The term ``qualified 
        countermeasure'' has the meaning given that term in section 
        319F-1 of the Public Health Service Act.
            (2) Security countermeasure.--The term ``security 
        countermeasure'' has the meaning given that term in section 
        319F-2 of the Public Health Service Act.

                  TITLE VII--BIOSHIELD EXPORT PRIORITY

SEC. 701. SHORT TITLE.

    This title may be cited as the ``Bioshield Export Priority Act''.

SEC. 702. REQUIREMENT TO EXPEDITE EXPORT APPLICATIONS.

    (a) In General.--The Secretary of Commerce or the Secretary of 
Health and Human Services, whichever is applicable, shall expedite the 
processing of a request to export a drug, medical device, diagnostic 
test, etiological agent, biological product, or any item the export of 
which is restricted pursuant to section 5 or 6 of the Export 
Administration Act of 1979 (as in effect pursuant to the International 
Emergency Economic Powers Act; 50 U.S.C. 1701 et seq.), if the export 
of that drug, medical device, diagnostic test, etiological agent, 
biological product, or other item is necessary to carry out a 
procurement contract entered into by the Secretary of Health and Human 
Services under the authority provided in section 319F-1 or section 
319F-2 of the Public Health Service Act (42 U.S.C. 247d-6a and 247d-
6b), or by the Secretary of Homeland Security under section 512 of the 
Homeland Security Act of 2002, with respect to a qualified 
countermeasure or security countermeasure under such contract.
    (b) Qualified and Security Countermeasures Defined.--In this 
section:
            (1) the term ``qualified countermeasure'' has the meaning 
        given that term in section 319F-1 of the Public Health Service 
        Act (42 U.S.C. 247d-6a); and
            (2) the term ``security countermeasure'' has the meaning 
        given that term in section 319F-2 of the Public Health Service 
        Act (42 U.S.C. 247d-6b).

SEC. 703. PRESERVATION OF FOREIGN SALES MARKETS FOR QUALIFIED AND 
              SECURITY COUNTERMEASURES.

    Notwithstanding any other provision of law, no Federal agency shall 
sell, barter, trade, or transfer a qualified countermeasure or a 
security countermeasure to a foreign government, or to any other 
foreign entity or purchaser outside the United States where an entity 
that has successfully developed a countermeasure under this Act or the 
Project BioShield Act of 2004 (Public Law 108-276) (and the amendments 
made by such Acts) is able to sell, barter, trade, or transfer such 
countermeasure to such foreign government or entity, unless the 
President makes a determination that such sale, barter, trade, or 
transfer is necessary for protecting the national security or national 
defense of the United States.

     TITLE VIII--OFFICE OF PUBLIC HEALTH COUNTERMEASURE DEVELOPMENT

SEC. 801. OFFICE OF PUBLIC HEALTH COUNTERMEASURE DEVELOPMENT.

    Section 2811(a) of the Public Health Service Act (42 U.S.C. 300hh-
11(a)) is amended to read as follows:
    ``(a) Assistant Secretary for Public Health Countermeasure 
Development.--
            ``(1) In general.--There is established within the 
        Department of Health and Human Services the Office of Public 
        Health Countermeasure Development (referred to in this 
        subsection as the `Office'). Such Office shall be headed by an 
        Assistant Secretary for Public Health Countermeasure 
        Development, who shall be appointed by the President and shall 
        report to the Secretary.
            ``(2) Deputy director.--There is established within the 
        Department of Health and Human Services the position of Deputy 
        Director for Medical Countermeasure Development.
            ``(3) Duties.--The Assistant Secretary for Public Health 
        Countermeasure Development shall ensure that research supported 
        by the Department of Health and Human Services--
                    ``(A) is consistent with the national preparedness 
                plan developed under section 2812 with respect to--
                            ``(i) identifying priorities, goals, 
                        objectives, and policies for identifying, 
                        developing, delivering, and evaluating medical 
                        and other countermeasures to biological, 
                        chemical, radiological, nuclear, and other 
                        emerging natural and terrorists threats and 
                        infectious diseases and research tools and 
                        countermeasures should include containment and 
                        decontamination strategies for human and animal 
                        remains; and
                            ``(ii) coordinating the civilian efforts of 
                        the Federal Government to identify and rapidly 
                        develop such countermeasures; and
                    ``(B) is conducted pursuant to a comprehensive, 
                research-based strategy for--
                            ``(i) the conduct of basic and applied 
                        research;
                            ``(ii) the development of the 
                        countermeasures described under subparagraph 
                        (A)(i); and
                            ``(iii) the development of standards by 
                        which the goals of such strategy may be 
                        accomplished and evaluated.''.

SEC. 802. BIOTERROR, CHEMICAL, NUCLEAR, RADIOLOGICAL, AND INFECTIOUS 
              DISEASE COUNTERMEASURE DEVELOPMENT STRATEGY.

    Subtitle B of title XXVIII of the Public Health Service Act (42 
U.S.C. 300hh-11 et seq.) is amended by adding at the end the following:

``SEC. 2812. BIOTERROR, CHEMICAL, NUCLEAR, RADIOLOGICAL, AND INFECTIOUS 
              DISEASE COUNTERMEASURE DEVELOPMENT STRATEGY.

    ``(a) Plan for Countermeasure Research.--
            ``(1) In general.--The Secretary, in consultation with the 
        Secretary of Defense and the Secretary of Homeland Security, 
        shall develop a comprehensive, long-term plan for engaging 
        State and local public health officials, medical examiners, and 
        other non-Federal entities, including private for-profit 
        entities, in the research, development, production, delivery, 
        and evaluation of countermeasures for biological, chemical, 
        radiological, and nuclear weapons and infectious diseases.
            ``(2) Contents.--The plan described under paragraph (1) 
        shall include a plan for the development of countermeasures for 
        exotic pathogens (including vaccine resistant bacterial or 
        viral strains, antibiotic resistant organisms, genetically 
        modified organisms, hybrid organisms, synthetic organisms, 
        autoimmune peptides, antibiotic-induced toxins, ethnic and 
        racial specific pathogens, and bioregulators and biomodulators) 
        and measures for containment and safe handling of contaminated 
        human and animal remains.
            ``(3) Other duties.--The Secretary, in consultation with 
        the Secretary of Defense and the Secretary of Homeland 
        Security, shall--
                    ``(A) develop a plan and strategy for engaging 
                pharmaceutical and biotechnology companies, 
                universities, small businesses, and nonprofit 
                institutions, including entities that are under-
                resourced and not able to advance beyond preclinical 
                development to clinical trials, in order to create a 
                multi-dimensional biodefense, infectious disease, 
                vaccine, and research tool industry; and
                    ``(B) provide joint oversight of translational 
                development for biodefense drug and vaccine candidates, 
                as provided in section 319F-2(o).
            ``(4) Coordination; purpose.--In developing the plan 
        described under paragraph (1), the Secretary, in consultation 
        with the Secretary of Defense and the Secretary of Homeland 
        Security, shall--
                    ``(A) consult with--
                            ``(i) other Federal agencies with expertise 
                        in research, development, and production of the 
                        countermeasures described under paragraph (1);
                            ``(ii) private, for-profit entities, State 
                        and local public health officials, medical 
                        examiners, and entrepreneurs with expertise and 
                        technology with respect to such 
                        countermeasures, research tools, and the 
                        systems for developing such research tools;
                            ``(iii) investors that fund the entities 
                        described under clause (ii);
                            ``(iv) nonprofit research universities and 
                        institutions;
                            ``(v) professional organizations 
                        representing infectious disease physicians and 
                        scientists;
                            ``(vi) local public health and hospital 
                        organizations; and
                            ``(vii) national and international 
                        healthcare delivery and public health entities, 
                        and other interested private and public 
                        entities;
                    ``(B) evaluate proposals to ensure that--
                            ``(i) Federal efforts assist and 
                        incentivize private sector development of 
                        systems to facilitate and expedite the 
                        development and diffusion of research tools, 
                        and research tool systems, to aid in the 
                        development and deployment of countermeasures;
                            ``(ii) research and development of such 
                        countermeasures by non-Federal entities is 
                        likely to yield countermeasures that may be 
                        procured and deployed with respect to the 
                        homeland security in the United States and 
                        against an infectious diseases;
                            ``(iii) ample investor capital is available 
                        to fund such research and development, and non-
                        Federal entities are not dependent on grants 
                        from the Federal Government;
                            ``(iv) the terms of procurement of such 
                        countermeasures are defined in advance so that 
                        entities may accurately and reliably assess--
                                    ``(I) the potential countermeasures 
                                market;
                                    ``(II) the potential rate of 
                                return; and
                                    ``(III) that the terms of the 
                                procurement are comparable to the 
                                procurement of other medicines and 
                                biological products from other markets;
                            ``(v) appropriate intellectual property, 
                        risk protection, and Government approval 
                        standards are applicable to such 
                        countermeasures;
                            ``(vi) federally funded research is 
                        conducted and prioritized to address the 
                        highest priority countermeasure detection tools 
                        and transfer or license those technologies, as 
                        appropriate, to non-Federal entities for 
                        production; and
                            ``(vii) universities, State and local 
                        government laboratories, and research 
                        institutions play a vital role as partners in 
                        research, development, and technology transfer, 
                        with appropriate progress benchmarks for such 
                        activities, with for-profit entities; and
                    ``(C) provide the private sector with sufficient 
                advance notice of the procurement priorities of the 
                Federal Government with respect to countermeasures.
            ``(5) Plan details.--
                    ``(A) In general.--The plan described under 
                paragraph (1) shall, on an annual basis--
                            ``(i) designate, in 5 year increments, 
                        specific countermeasures for which contracts 
                        under the Project BioShield Act of 2004 and the 
                        Project BioShield II Act of 2005 will be 
                        awarded;
                            ``(ii) estimate the date on which request 
                        for proposals will be published;
                            ``(iii) provide information regarding the 
                        qualifications of the entities with which it 
                        may enter into an agreement; and
                            ``(iv) list the projected schedule for the 
                        completion of the development of such 
                        countermeasures.
                    ``(B) Designation of countermeasures.--
                            ``(i) In general.--The plan described in 
                        paragraph (1) shall, on an annual basis, 
                        designate specific countermeasures to be 
                        developed against terror weapons or weapons of 
                        mass destruction.
                            ``(ii) Infectious disease countermeasures 
                        in the united states.--For every 5 such 
                        countermeasures designated under clause (i), 
                        not less than 2 additional countermeasures 
                        shall be designated for development against an 
                        infectious disease that--
                                    ``(I) is not a terror weapon or 
                                weapon of mass destruction; and
                                    ``(II) has or may have substantial 
                                incidence in the United States.
                            ``(iii) Global infectious disease 
                        countermeasures in developing countries.--For 
                        every 5 such countermeasures designated under 
                        clause (i), not less than 2 additional 
                        countermeasures shall be designated for 
                        development against an infectious disease 
                        that--
                                    ``(I) is not a terror weapon or 
                                weapon of mass destruction; and
                                    ``(II) has or may have substantial 
                                incidence largely in developing 
                                countries.
                    ``(C) Designation of research tools; purchase 
                pools; estimation.--The plan described in paragraph (1) 
                shall--
                            ``(i) designate research tools, including 
                        research tool systems, to be developed;
                            ``(ii) identify purchase pools with which 
                        the Secretary shall seek to negotiate for the 
                        development of countermeasures; and
                            ``(iii) estimate the amount of 
                        appropriations necessary to procure the 
                        development of such countermeasures and 
                        research tools.
                    ``(D) Public availability.--The plan described in 
                paragraph (1) shall be published in the Federal 
                Register.
            ``(6) Performance measure system.--
                    ``(A) In general.--Not later than 180 days after 
                the development of the plan described in paragraph (1), 
                the Secretary shall implement a performance measure 
                system to evaluate the progress toward the goals of the 
                Project BioShield II Act of 2005, which shall include a 
                list of clear, measurable benchmarks by which progress 
                may be evaluated, including--
                            ``(i) a list of threats for which 
                        countermeasures are necessary;
                            ``(ii) a list of research and research tool 
                        systems necessary for the development of 
                        countermeasures;
                            ``(iii) systems to develop and deliver 
                        countermeasures for at-risk populations;
                            ``(iv) an annual accounting of the number 
                        of outbreaks, including incidence numbers and 
                        case fatality rates, in the United States of 
                        influenza and other such diseases that such Act 
                        addresses;
                            ``(v) a list of any new threats that either 
                        emerged from nature, or that were engineered 
                        and released during the previous year; and
                            ``(vi) an accounting of the time that it 
                        took to detect, analyze, and respond to any 
                        instance of a threat.
                    ``(B) Evaluation.--Not later than 1 year after the 
                publication of the benchmarks described in subparagraph 
                (A), and on annual basis thereafter, the Secretary 
                shall publish and submit to Congress an evaluation of 
                the progress made with respect to such benchmarks 
                during the preceding year.
            ``(7) Submission of plan; reporting.--
                    ``(A) Submission of plan.--Not later than 270 days 
                after the date of enactment of the Project BioShield II 
                Act of 2005, the Secretary shall submit to Congress the 
                plan developed under paragraph (1) and recommendations 
                for the enactment of supporting or enabling legislation 
                with respect to such plan. The Secretary shall submit 
                to Congress an updated version of such plan and such 
                recommendations on an annual basis.
                    ``(B) Reporting.--The Secretary shall report 
                periodically to Congress on the status of the 
                countermeasure research, development, and production of 
                non-Federal entities, and submit recommendations for 
                legislation as determined necessary by the Secretary.
    ``(b) Advisory Committee.--
            ``(1) Establishment of committee.--The Secretary, in 
        consultation with the Secretary of Defense and the Secretary of 
        Homeland Security, shall establish an advisory committee to be 
        known as the Public Health Countermeasure Development Advisory 
        Committee (referred to in this section as the `Advisory 
        Committee').
            ``(2) Duties.--The Advisory Committee shall advise the 
        Secretary, the Secretary of Defense, and the Secretary of 
        Homeland Security with respect to the establishment of a 
        biodefense, an infectious disease, vaccine, and a research tool 
        industry to supply the Federal Government and other public 
        entities with the medical countermeasures necessary to protect 
        the public from biological, chemical, radiological, and nuclear 
        attacks, or infectious diseases.
            ``(3) Membership.--The Secretary, Secretary of Defense, and 
        the Secretary of Homeland Security shall appoint the members of 
        the Advisory Committee, which shall be composed of--
                    ``(A) representatives of the for-profit and 
                nonprofit research sectors, and State and local 
                governments, including representatives of the small 
                business industry and infectious disease medical, 
                research, biotechnology, and pharmaceutical 
                communities; and
                    ``(B) experts on the terms and impact of the 
                incentives provided under the Project BioShield Act of 
                2004 or the Project BioShield II Act of 2005 (and the 
                amendments made by such Acts).
            ``(4) Vacancies.--Any vacancy in the Advisory Committee 
        shall not affect its powers, but shall be filled in the same 
        manner as the original appointment.
            ``(5) Meetings.--The Advisory Committee shall meet at the 
        call of the co-chairpersons.
            ``(6) Co-chairpersons.--The Secretary, the Secretary of 
        Defense, and the Secretary of Health and Human Services shall 
        serve as the co-chairpersons of the Advisory Committee.
            ``(7) Powers.--
                    ``(A) Hearings.--The Advisory Committee may hold 
                such hearings, sit and act at such times and places, 
                take such testimony, and receive such evidence as the 
                Advisory Committee considers advisable to carry out 
                this section.
                    ``(B) Information from federal agencies.--
                            ``(i) In general.--The Advisory Committee 
                        may secure directly from any Federal department 
                        or agency such information as the Advisory 
                        Committee considers necessary to carry out the 
                        provisions of this section. Upon request of the 
                        Advisory Committee, the head of such department 
                        or agency shall furnish such information to the 
                        Advisory Committee.
                            ``(ii) Limitation.--Nothing in this 
                        subsection shall be construed to allow the 
                        Advisory Committee to secure information that 
                        is exempt from disclosure under section 552 of 
                        title 5, United States Code (commonly referred 
                        to as the Freedom of Information Act).
                    ``(C) Postal services.--The Advisory Committee may 
                use the United States mails in the same manner and 
                under the same conditions as other departments and 
                agencies of the Federal Government.
            ``(8) Personnel.--
                    ``(A) Travel expenses.--The members of the Advisory 
                Committee shall not receive compensation for the 
                performance of services for the Advisory Committee, but 
                shall be allowed travel expenses, including per diem in 
                lieu of subsistence, at rates authorized for employees 
                of agencies under subchapter I of chapter 57 of title 
                5, United States Code, while away from their homes or 
                regular places of business in the performance of 
                services for the Advisory Committee. Notwithstanding 
                section 1342 of title 31, United States Code, the 
                Secretary may accept the voluntary and uncompensated 
                services of members of the Advisory Committee.
                    ``(B) Detail of government employees.--Any Federal 
                Government employee may be detailed to the Advisory 
                Committee without reimbursement, and such detail shall 
                be without interruption or loss of civil service status 
                or privilege.''.

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.

    (a) In General.--Title VIII of the Homeland Security Act of 2002 (6 
U.S.C. 361 et seq.) is amended by inserting after section 879 the 
following:

``SEC. 879A. OFFICE OF MEDICAL READINESS AND RESPONSE.

    ``(a) Establishment.--There is established within the Office of the 
Secretary an Office of Medical Readiness and Response.
    ``(b) Assistant Secretary.--The Office established under subsection 
(a) shall be headed by an Assistant Secretary for Medical Readiness and 
Response, who shall be appointed by the President by and with the 
advice and consent of the Senate.
    ``(c) Duties of the Assistant Secretary.--The Assistant Secretary 
for Medical Readiness and Response shall--
            ``(1) serve as the principal advisor to the Secretary on 
        all matters related to emergency medical preparedness and 
        response;
            ``(2) develop Federal strategy, training (including 
        exercises), coordination, funding, and implementation of 
        emergency medical response to mass casualty events for Federal, 
        State, and local public health agencies and private sector 
        entities in support of homeland security;
            ``(3) serve as the primary Federal official with respect to 
        overseeing the identification and development, in consultation 
        with nonprofit health and public health departments and medical 
        centers, of medical preparedness centers and deployable medical 
        care units designed to meet the demands of a terrorist event or 
        other incident requiring mass casualty care and containment of 
        infectious disease;
            ``(4) serve as the primary official of the Department 
        relating to and overseeing medical emergencies, including 
        emergencies incident to a terrorist attack or naturally 
        occurring infectious disease outbreak;
            ``(5) in coordination with the Secretary of Health and 
        Human Services, have the authority to deploy the Strategic 
        National Stockpile and the Commissioned Corps of the Public 
        Health Service;
            ``(6) report directly to the Secretary; and
            ``(7) evaluate and report to Congress on the preparedness 
        of Federal, State, and local agencies to respond to major 
        medical disaster.
    ``(d) Functions.--There shall be transferred to the Office of 
Medical Readiness and Response the following functions, personnel, 
assets, and liabilities of the following:
            ``(1) The National Disaster Medical System (transferred to 
        the Department pursuant to section 503(5)).
            ``(2) The Metropolitan Medical Response System (transferred 
        to the Department pursuant to section 503(5)).
            ``(3) The emergency medical response functions of the 
        Office of Emergency Preparedness (transferred to the Department 
        pursuant to section 503(5)).
            ``(4) Other resources and offices of the Department as 
        designated by the Secretary.''.
    (b) Conforming amendments.--Section 502(3) of the Homeland Security 
Act of 2002 (6 U.S.C. 312(3)) is amended--
            (1) in subparagraph (B)--
                    (A) by striking ``, the National Disaster Medical 
                System,''; and
                    (B) by striking the semicolon and inserting ``; 
                and'';
            (2) by striking subparagraph (C); and
            (3) by redesignating subparagraph (D) as subparagraph (C).

    TITLE X--NATIONAL EMERGENCY MEDICAL READINESS AND RESPONSE BOARD

SEC. 1001. NATIONAL EMERGENCY MEDICAL READINESS AND RESPONSE BOARD.

    (a) In General.--Title VIII of the Homeland Security Act of 2002 (6 
U.S.C. 361 et seq.), as amended by section 901, is further amended by 
inserting after section 879A (as added by section 901) the following:

``SEC. 879B. NATIONAL EMERGENCY MEDICAL READINESS AND RESPONSE BOARD.

    ``(a) Establishment of Board.--
            ``(1) In general.--There is established in the Department 
        the National Emergency Medical Readiness and Response Board 
        (referred to in this section as the `Board').
            ``(2) Chairperson.--The Assistant Secretary for Medical 
        Readiness and Response shall serve as the chairperson of the 
        Board.
            ``(3) Composition.--The Board shall be composed of the 
        following members (or their designees):
                    ``(A) The Assistant Secretary for Medical Readiness 
                and Response.
                    ``(B) The United States Surgeon General.
                    ``(C) The Assistant Secretary for Public Health 
                Countermeasure Development.
                    ``(D) The Director of the National Institutes of 
                Health.
                    ``(E) The Director of the Centers for Disease 
                Control and Prevention.
                    ``(F) The Director of National Bioterrorism and 
                Hospital Readiness of the Health Resources and Services 
                Administration.
                    ``(G) The Deputy Assistant to the Secretary of 
                Defense for Chemical and Biological Defense.
                    ``(H) The Commanding General, Army Medical Research 
                and Materiel Command.
                    ``(I) The Assistant Secretary for Health of the 
                Department of Veterans Affairs.
                    ``(J) The Deputy Commander, United States Northern 
                Command.
                    ``(K) The Commissioner of Food and Drugs.
                    ``(L) The Secretary of Agriculture.
                    ``(M) The Postmaster General.
                    ``(N) Any other individual appointed by the 
                President to the Board.
            ``(4) Meetings.--The Board shall meet at the call of the 
        chairperson.
    ``(b) Duties and Powers.--
            ``(1) Duties.--The Board shall oversee the following 
        activities:
                    ``(A) The development, assessment, and validation 
                of national, interagency, emergency medical response 
                plans, in coordination with State and local public 
                health officials, for bioterrorism (including 
                agroterrorism), chemical attack, radiological attack, 
                nuclear attack, infectious disease, and high explosives 
                attack.
                    ``(B) In cooperation with State and local public 
                health agencies, the development, testing, and 
                implementation of a plan for the necessary training 
                related to, and the assessment and evaluation of, the 
                Federal emergency medical response plans described in 
                subparagraph (A).
                    ``(C) The coordination of the Federal emergency 
                medical response plans described in subparagraph (A) 
                among all the Federal departments and agencies 
                represented on the Board through joint exercises that 
                shall be observed and evaluated by the members of the 
                Board (or their designees).
                    ``(D) Defining, and determining when and how to 
                implement, national level emergency medical response 
                plans to medical disasters.
            ``(2) Powers.--The Board may secure directly from any 
        Federal department or agency such information as the Board 
        considers necessary to carry out this subsection. Upon request 
        of the chairperson of the Board, the head of such department or 
        agency shall furnish such information to the Board.
    ``(c) Board Personnel Matters.--
            ``(1) Detail of government employees.--Any Federal 
        Government employee may be detailed to the Board without 
        reimbursement, and such detail shall be without interruption or 
        loss of civil service status or privilege.
            ``(2) Procurement of temporary and intermittent services.--
        The chairperson of the Board may procure temporary and 
        intermittent services under section 3109(b) of title 5, United 
        States Code, at rates for individuals which do not exceed the 
        daily equivalent of the annual rate of basic pay prescribed for 
        level V of the Executive Schedule under section 5316 of such 
        title.
    ``(d) Advisory Committee.--
            ``(1) Establishment.--Not later than 180 days after the 
        date of enactment of the Project BioShield II Act of 2005, the 
        Assistant Secretary for Medical Readiness and Response shall 
        establish an advisory committee that shall provide assistance 
        and oversight to the Board and to the Assistant Secretary for 
        Medical Readiness and Response.
            ``(2) Composition.--The advisory committee established 
        pursuant to paragraph (1) shall consist of representatives, 
        appointed by the Assistant Secretary for Medical Readiness and 
        Response, of--
                    ``(A) designees of State and local public health 
                and emergency management agencies;
                    ``(B) State and local emergency managers or 
                adjutant generals and State emergency medical services 
                directors;
                    ``(C) physicians and first responders (including 
                nurses, police, and paramedics);
                    ``(D) academic medical research institutions;
                    ``(E) the World Health Organization;
                    ``(F) the International Committee of the Red Cross;
                    ``(G) the International Federation of Red Cross and 
                Red Crescent Societies;
                    ``(H) the American Red Cross;
                    ``(I) the Infectious Disease Society of America;
                    ``(J) professional medical and clinical societies, 
                as appropriate;
                    ``(K) local hospitals and hospital districts;
                    ``(L) medical care delivery facilities (hospital 
                outpatient centers);
                    ``(M) pharmacies;
                    ``(N) accredited schools of public health;
                    ``(O) pathologists, coroners, and chief medical 
                examiners; and
                    ``(P) other individuals and representatives of 
                entities appointed by the Assistant Secretary for 
                Medical Readiness and Response to the advisory 
                committee.''.
    (b) Conforming Amendments.--The table of contents in section 1(b) 
of the Homeland Security Act of 2002 (6 U.S.C. 101 note) is amended 
by--
            (1) inserting after the item relating to section 511 the 
        following:

``Sec. 510. Countermeasure Purchase Fund at the Department of Homeland 
                            Security.'';

        and
            (2) inserting after the item relating to section 879 the 
        following:

``Sec. 879A. Office of Medical Readiness and Response.
``Sec. 879B. 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.

    (a) Purpose.--The purpose of this section is to direct the 
Department of State and the Department of Commerce to develop and 
implement a program to secure the access to, and transfer of, 
compounds, culture collections, devices, scientific methods, and 
research tools to the United States to further the protection of the 
United States and its allies against biological, chemical, nuclear, and 
radiological agents or infectious diseases. Such an effort must address 
the state of intellectual property of such items and ensure the 
security of such intellectual property to allow for and encourage 
commercialization.
    (b) Report.--
            (1) In general.--Not later than 180 days after the date of 
        enactment of the Project BioShield II Act of 2005, the 
        Secretary of State, in cooperation with the Secretary of 
        Homeland Security and Secretary of Commerce, shall report to 
        the Committee on Foreign Relations of the Senate and the 
        Committee on International Relations of the House of 
        Representatives on the existence and adequacy of all United 
        States Government-sponsored programs or organizations 
        responsible for encouraging commercialization of 
        countermeasures developed by former-Soviet scientists and 
        current scientists working within the Commonwealth of 
        Independent States (referred to in this section as ``CIS'').
            (2) Content of report.--The report described under 
        paragraph (1) shall identify any known legal prohibitions and 
        practical challenges in the United States or CIS to the 
        purposes of this section, including laws governing intellectual 
        property, export controls, and classification of information 
        restricting or inhibiting private-sector exchange and 
        development of such countermeasures. The Secretary of State 
        shall provide such information as the Secretary determines to 
        be necessary to enable such potential commercialization and 
        cooperation.

 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.

    Section 319 of the Public Health Service Act (42 U.S.C. 247d) is 
amended by adding at the end the following:
    ``(e) Continuity of National Healthcare System in an Emergency.--
            ``(1) Emergency health insurance reimbursement.--In the 
        event of a public health emergency determined pursuant to 
        subsection (a), the Secretary may guarantee reimbursement to 
        public and private healthcare providers (which shall include 
        nurses and non-clinical staff) for care related to the public 
        health emergency provided to individuals by such providers to 
        the extent that the public or private health insurance 
        reimbursement (as the case may be) to such providers is not 
        applicable because of war or terrorism coverage exclusions at 
        one of the following rates:
                    ``(A) The applicable rates under the Medicare and 
                Medicaid programs.
                    ``(B) A per diem rate determined by the Secretary.
            ``(2) Guarantee of payments.--During a closure of the 
        United States mails due to a public health emergency determined 
        pursuant to subsection (a), the Secretary may provide a 
        guarantee of payment to private healthcare providers to enable 
        such providers to maintain services and continuity in response 
        to such emergency.''.

SEC. 1202. REIMBURSEMENT OF INFECTIOUS DISEASE PHYSICIANS FOR COMMUNITY 
              EMERGENCY PREPAREDNESS ACTIVITIES.

    Section 319 of the Public Health Service Act (as amended by section 
1201) is further amended by adding at the end the following:
    ``(f) Reimbursement of Infectious Disease Physicians for Community 
Emergency Preparedness Activities.--The Secretary shall reimburse 
board-certified infectious disease and public health specialists for 
services provided during a public health emergency under subsection (a) 
at applicable rates under the Medicare program, to the extent that such 
services are not otherwise wholly reimbursed by other public or private 
insurance.''.

SEC. 1203. MEDICAL LICENSE RECIPROCITY.

    Section 319 of the Public Health Service Act (42 U.S.C. 247d) (as 
amended by section 1202) is further amended by adding at the end the 
following:
    ``(g) Medical License Reciprocity.--The Secretary may issue 
regulations requiring the establishment of reciprocity of medical 
licensing and certification between or among States during a national 
or local public health emergency determined pursuant to subsection (a).
    ``(h) Minimum Standards.--Medical licensing for the purposes of 
subsection (g) shall include the licensing of allopathic and 
osteopathic physicians, registered nurses, nurse practitioners, 
physician assistants, pharmacists, paramedics, respiratory therapists, 
and other first responders or allied health professionals.
    ``(i) PSA.--The Secretary may issue regulations requiring or 
providing appropriate liability and workman's compensation coverage for 
healthcare professionals and others responding to a public health 
emergency, as determined under subsection (a).''.

SEC. 1204. LIABILITY PROTECTION FOR HEALTHCARE VOLUNTEERS AND 
              HOSPITALS.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) (as amended by sections 202, 1402, 1631, 1901, 2101, 2102, and 
1631) is amended by inserting after section 319F-9 (as added by section 
203) the following:

``SEC. 319F-10. LIABILITY PROTECTION FOR HEALTHCARE VOLUNTEERS AND 
              HOSPITALS LITIGATION MANAGEMENT.

    ``(a) Federal Cause of Action.--
            ``(1) In general.--There shall exist an exclusive Federal 
        cause of action for claims arising out of, related to, or 
        resulting from care delivered by any person or entity at any 
        location in the United States if the governor of that State has 
        declared a state of emergency, or the Secretary of Health and 
        Human Services declares that a public health emergency is in 
        effect in that State, or the President signs a disaster 
        declaration for that State. Such Federal cause of action shall 
        be brought in the United States district court for the District 
        of Columbia and shall be only for injuries that are caused by 
        willful or wanton misconduct.
            ``(2) Limitations.--Healthcare personnel, volunteers, and 
        other workers providing emergency medical or triage care in 
        field settings, alternative treatment facilities, and in 
        vaccination or medication distribution settings shall be immune 
        from claim for loss of property (including business 
        interruption or other types of indirect losses), personal 
        injury, or death.
    ``(b) Special Rules.--
            ``(1) In general.--When a hospital is providing care under 
        emergency conditions as described in this section and such care 
        is not administered for or in expectation of compensation, then 
        the maximum liability to the Federal Government on behalf of 
        the hospital (or its employees, volunteers, officers, and 
        directors) is $250,000 for each claimant.
            ``(2) Punitive damages.--No punitive damages intended to 
        punish or deter, exemplary damages, or other damages not 
        intended to compensate a plaintiff for actual medical expenses 
        or lost wages may be awarded in an action under this section, 
        nor shall any party in such action be liable for interest prior 
        to the judgment.
            ``(3) Noneconomic damages.--No noneconomic damages may be 
        awarded for claims under this section.
            ``(4) Limitations.--Hospitals and other health care 
        organizations shall be immune from vicarious liability for the 
        actions of volunteers providing care under emergency conditions 
        described in this section, even if the hospital or health care 
        organization is considered the employer for worker' 
        compensation purposes.
            ``(5) Attorney fees.--Attorney fees in an action under this 
        section shall be calculated on a reasonable amount of work 
        performed on behalf of the plaintiff.''.

TITLE XIII--ADEQUACY OF EMERGENCY MEDICAL RESPONSE ASSETS FOR HOMELAND 
                           SECURITY MISSIONS

SEC. 1301. ADEQUACY OF EMERGENCY MEDICAL RESPONSE ASSETS FOR HOMELAND 
              SECURITY MISSIONS.

    (a) Study.--The Assistant Secretary for Medical Readiness and 
Response of the Department of Homeland Security shall perform a study 
and prepare a report assessing the state of medical and health 
readiness and response capability to respond to large-scale medical 
emergencies, such as terrorist actions. The study will evaluate the 
following aspects of medical and health readiness and response:
            (1) The nature and extent of emergency medical and health 
        resources needed to respond to and mitigate a biological, 
        chemical, radiological, or nuclear attack or an infectious 
        disease outbreak.
            (2) The assets and resources currently available from the 
        Federal, State, and local governments, private sector entities, 
        industry, hospitals, and academia to meet the homeland security 
        mission.
            (3) The deficiencies in assets and resources needed to 
        respond to such an attack or outbreak.
            (4) Recommendations regarding the types and extent of 
        assets and resources needed to be secured to respond to such an 
        attack or outbreak, including those requested from State and 
        local public health agencies and their volunteer responders.
    (b) Content.--The report described in subsection (a) shall assess 
and make recommendations with regard to--
            (1) the appropriate roles and responsibilities in 
        responding to a medical emergency of--
                    (A) full-time government employees;
                    (B) part-time personnel; and
                    (C) volunteer personnel;
            (2) the appropriate skills and skilled workers needed, 
        including physicians (including infectious diseases 
        specialists), other health care personnel, and first 
        responders;
            (3) the appropriate planning and training needed prior to 
        an attack or outbreak;
            (4) the appropriate contingency plans for responding to a 
        novel or catastrophic incident; and
            (5) mechanisms to--
                    (A) develop and pilot test strategies to be used to 
                reduce disease transmission in a bioterrorism incident, 
                a public health emergency, or an epidemic or pandemic;
                    (B) develop and validate meaningful national 
                standards for Federal, State, and local public health 
                agencies and for nongovernmental healthcare delivery 
                institutions in preparedness for and response to 
                epidemics, pandemics, and mass casualty incidents;
                    (C) test these methods in State, local, and multi-
                State proof-of-concept tests; and
                    (D) develop public risk communication tools that 
                support the widespread use of such activities.
    (c) Consultation.--In preparing this report, the Assistant 
Secretary for Medical Readiness and Response of the Department of 
Homeland Security shall consult with the members of the National 
Emergency Preparedness and Response Board.
    (d) Submission Date.--The report shall be submitted to Congress not 
later than 1 year after the date of enactment of this Act.

  TITLE XIV--CONSTRUCTION OF SPECIALIZED RESEARCH FACILITIES FOR THE 
                     DEVELOPMENT OF COUNTERMEASURES

SEC. 1401. CONSTRUCTION OF SPECIALIZED RESEARCH FACILITIES FOR THE 
              DEVELOPMENT OF COUNTERMEASURES.

    (a) In General.--Part B of title III of the Public Health Service 
Act (42 U.S.C. 243 et seq.) (as amended by sections 202, 1901, 2101, 
and 2102) is amended by inserting after section 319F-6 (as added by 
section 2102) the following:

``SEC. 319F-7. CONSTRUCTION OF BIOSAFETY LEVEL 3-4 RESEARCH FACILITIES.

    ``(a) Findings.--Congress finds that--
            ``(1) research to develop countermeasures requires the use 
        of special facilities where biological and chemical agents can 
        be handled safely both for laboratory research and efficacy 
        testing in animal models;
            ``(2) very few companies and very few State and local 
        public health laboratories have sufficient funds for the 
        construction of these special facilities; and
            ``(3) the Federal Government can facilitate research and 
        development of countermeasures by financing the construction of 
        these special facilities.
    ``(b) Grants Authorized.--
            ``(1) In general.--The Secretary is authorized to award 
        grants and contracts to grantees to construct, maintain, and 
        manage (including funding for staff and staff training) 
        biosafety level 3-4 facilities.
            ``(2) Requirements.--To be eligible for a grant under 
        paragraph (1) an entity shall--
                    ``(A) allow use of the facility involved by only 
                those researchers who meet qualifications set by the 
                Secretary;
                    ``(B) give priority for the use of the facility 
                involved to those entities that have been registered 
                and certified by the Secretary to develop 
                countermeasures; and
                    ``(C) allow the National Institutes of Health and 
                the Centers for Disease Control and Prevention to 
                inspect the facility involved at any time.
            ``(3) Number of grants.--The Secretary of Homeland Security 
        shall determine the number of facilities that need to be 
        constructed under this section, not to exceed 10 such 
        facilities nationwide, and the Secretary shall award grants 
        based on such determination.
    ``(c) Application.--
            ``(1) In general.--To be eligible to receive a grant under 
        this section, an entity shall submit to the Secretary an 
        application at such time, in such form, and containing such 
        information as the Secretary may require.
            ``(2) Contents.--Each application submitted pursuant to 
        paragraph (1) shall--
                    ``(A) provide detailed information on the technical 
                specifications of proposed facilities;
                    ``(B) propose a design that includes offices for 
                personnel, visiting researchers, and facilities for 
                research and laboratory materials; and
                    ``(C) provide assurances that--
                            ``(i) the facilities shall be available on 
                        a fee-for-service or other basis to companies 
                        and academic researchers;
                            ``(ii) such services offered to companies 
                        and academic researchers shall include testing 
                        and validation studies for all types of 
                        countermeasures, including detection 
                        technology;
                            ``(iii) such facilities shall utilize the 
                        research tools identified by the Secretary in 
                        section 319F-3 of this Act or certified under 
                        section 301(b)(4) of the Project BioShield II 
                        Act of 2005; and
                            ``(iv) that the facilities will be 
                        constructed as secure facilities.
    ``(d) Definitions.--For the purposes of this section--
            ``(1) unless otherwise specifically identified, the term 
        `Director' means the Director of the National Institutes of 
        Health;
            ``(2) the term `biosafety level 3 facility' means a 
        facility described in section 627.15 of title 32, Code of 
        Federal Regulations (or any successor regulation); and
            ``(3) the term `biosafety level 4 facility' means a 
        facility described in section 627.16 of title 32, Code of 
        Federal Regulation (or any successor regulation).
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this 
section.''.
    (b) Needs Assessment.--The Secretary of Health and Human Services 
shall conduct a study of regional and national laboratory capacities 
with respect to the laboratories described in section 319F-7 of the 
Public Health Service Act (as added by this title) before implementing 
such section.

TITLE XV--BIODEFENSE AND INFECTIOUS DISEASE RESEARCH AND SCIENTIFIC AND 
                          TECHNICAL PERSONNEL

SEC. 1501. ESTABLISHMENT OF GRANT PROGRAM.

    Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) is amended by adding at the end the following:

``SEC. 409J. GRANTS FOR BIODEFENSE AND INFECTIOUS DISEASE RESEARCH.

    ``(a) In General.--The Director of the Centers for Disease Control 
and Prevention (referred in this section as the `Director'), in 
consultation with the Assistant Secretary for Medical Readiness and 
Response of the Department of Homeland Security, and the Secretary of 
Defense shall establish a program to award grants and scholarships to 
eligible entities to ensure that sufficient scientific and technical 
personnel are available to conduct biodefense and infectious disease 
research.
    ``(b) Eligibility.--To be eligible to receive a grant or 
scholarship under subsection (a), an entity shall--
            ``(1) be--
                    ``(A) an individual who desires to acquire a 
                scientific or technical skill identified and listed by 
                the Director under subsection (c)(1)(A); or
                    ``(B) a facility or institution that is designated 
                as a scientific or technical skills facility under 
                subsection (c)(1)(B); and
            ``(2) submit to the Director an application, at such time, 
        in such manner, and containing such information as the Director 
        may require.
    ``(c) Identification of Scientific and Technical Skills 
Shortages.--
            ``(1) Assessment and designation.--
                    ``(A) In general.--Not later than 1 year after the 
                date of enactment of this section, and annually 
                thereafter, the Director shall, for purposes of this 
                section, assess the science and technical skills that 
                are needed for the development of medical 
                countermeasures to biological, chemical, nuclear, 
                radiological, and other emerging natural and terrorists 
                threats and infectious diseases, including the 
                expertise needed concerning the identification of 
                drugs, detection equipment, diagnostics, and research 
                tools with respect to such countermeasures. Upon 
                completion of such assessment, the Director shall 
                publish a list of the scientific and technical skills 
                so identified and for which there exists a shortage of 
                qualified individuals.
                    ``(B) Facilities.--Not later than 1 year after the 
                date of enactment of this section, and annually 
                thereafter, the Director shall designate public or 
                nonprofit private facilities or institutions that the 
                Director determines provides education or training with 
                respect to a scientific or technical skill identified 
                and published on the list under subparagraph (A).
            ``(2) Limitation on removal from list or designation.--The 
        Director shall not remove a skill from the list under paragraph 
        (1)(A) or a designation with respect to a facility or 
        institution under paragraph (1)(B) unless the Director has 
        afforded interested persons and groups an opportunity to 
        provide data and information in support of the listing or 
        designation involved, and has made a determination on the basis 
        of the data and information submitted by such persons and 
        groups and other data and information available to the 
        Director.
            ``(3) Criteria.--The Director shall establish by regulation 
        criteria for the listing of skills or designation of facilities 
        and institutions under paragraph (1).
            ``(4) Notice.--The Director shall give written notice of 
        the listing of a skill or designation of a facility or 
        institution not later than 60 days from the date of such 
        designation, to--
                    ``(A) the Governor of each State and official of 
                each local city or town in which the facility or 
                institution so designated is in whole or part located; 
                and
                    ``(B) appropriate public or nonprofit private 
                entities which provide education or training in the 
                skills so listed.
            ``(5) Recommended designation.--Any person may recommend to 
        the Director the listing or a skill or designation of a 
        facility or other institution under paragraph (1).
            ``(6) Dissemination of criteria.--The Director shall 
        disseminate information concerning the criteria described in 
        paragraph (3) to--
                    ``(A) the Governor of each State;
                    ``(B) the representative of any facility selected 
                by any such Governor to receive such information;
                    ``(C) the representative of any facility that 
                requests such information; and
                    ``(D) the representative of any facility determined 
                by the Director to be likely to meet such criteria.
    ``(d) Use of Funds.--
            ``(1) Scholarships.--
                    ``(A) In general.--Amounts provided to an 
                individual under a scholarship under subsection (a) 
                shall be used to obtain education leading to a degree 
                or postdoctoral training at a nonprofit institution 
                determined appropriate by the Secretary to further the 
                development of medical countermeasures to biological, 
                chemical, nuclear, radiological, and other emerging 
                terrorists threats and infectious diseases, including 
                the expertise needed concerning the identification and 
                development of drugs, detection equipment, human and 
                animal remains handling and containment equipment and 
                methods, diagnostics, and research tools with respect 
                to such countermeasures.
                    ``(B) Agreement to serve.--To be eligible to 
                receive a scholarship described in subparagraph (A), an 
                individual shall agree to enter into contract with the 
                Director for obligated service as provided for in 
                subparagraph (C).
                    ``(C) Obligated service.--An individual who has 
                entered into a written contract with the Director under 
                subparagraph (B) shall conduct countermeasures research 
                on a full-time basis in an area determined appropriate 
                by the Director for the period of obligated service 
                provided for in such contract.
                    ``(D) Period of service.--The period of obligated 
                service under a contract under subparagraph (B) shall 
                be equal to the greater of--
                            ``(i) 1 year for each school year for which 
                        the individual was provided a scholarship under 
                        subsection (a); or
                            ``(ii) 2 years.
                    ``(E) Breach of contract.--The provisions of 
                section 338E shall apply to a breach of contract under 
                this paragraph to the same extent that such provisions 
                apply to a breach of a scholarship contract under such 
                section.
            ``(2) Transition to workforce.--The Director is authorized 
        to provide assistance to Federal agencies to incorporate the 
        individuals who receive a grant under this section into the 
        Federal workforce, including non-tenured positions that could 
        transition into permanent positions at the end of the payback 
        period.
            ``(3) Grants.--Amounts awarded under a grant under 
        subsection (a) shall be used for activities that facilitate the 
        conduct of countermeasures research.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, such sums as may be 
necessary.''.

                TITLE XVI--NATIONAL INSTITUTES OF HEALTH

   Subtitle A--National Center for Healthcare Technology Development

SEC. 1601. PURPOSE.

    The purpose of this subtitle is to enhance the licensing of 
research, and protect the value of intellectual property, funded by the 
National Institutes of Health to companies to develop healthcare 
technologies for the benefit of patients.

SEC. 1602. NATIONAL CENTER FOR HEALTHCARE TECHNOLOGY DEVELOPMENT.

    (a) In General.--Part E of title IV of the Public Health Service 
Act (42 U.S.C. 287 et seq.) is amended by adding at the end the 
following:

   ``Subpart 7--National Center for Healthcare Technology Development

``SEC. 485K. NATIONAL CENTER FOR HEALTH CARE TECHNOLOGY DEVELOPMENT.

    ``(a) Definition.--In this subpart, the term `healthcare technology 
development program' means a program designed to--
            ``(1) maximize the technology development opportunities and 
        the return on the investment of the Federal Government in 
        research related to the development of human diagnostics, 
        therapeutics, anti-microbials, vaccines, and research tools so 
        that this investment provides clinical benefits to individuals;
            ``(2) ensure that research supported by the Federal 
        Government is complimentary to, and not duplicative of or 
        competitive with, private sector research;
            ``(3) speed the development of biomedical research enabling 
        human diagnostics, therapeutics, vaccines, and research tools; 
        and
            ``(4) reduce the time and cost necessary for the 
        development of human diagnostics, therapeutics, vaccines, and 
        research tools.
    ``(b) Establishment; Purpose.--
            ``(1) Establishment.--There is established within the 
        National Institutes of Health a National Center for Healthcare 
        Technology Development (referred to in this subpart as the 
        `Center').
            ``(2) Purpose.--The purpose of the Center is to increase 
        and support healthcare technology development, which includes--
                    ``(A) maximizing the technology development 
                opportunities and the return on the investment of the 
                Federal Government in research related to the 
                development of human diagnostics, therapeutics, 
                vaccines, and research tools so that this investment 
                provides clinical benefits to individuals;
                    ``(B) ensuring that research supported by the 
                Federal Government is complimentary to, and not 
                duplicative of or competitive with, private sector 
                research;
                    ``(C) speeding the development of biomedical 
                research enabling human diagnostics, therapeutics, 
                vaccines, and research tools; and
                    ``(D) reducing the cost and time necessary for the 
                development of human diagnostics, therapeutics, 
                vaccines, and research tools.
    ``(c) Director.--
            ``(1) In general.--The Center shall be headed by a Center 
        Director (referred to in this section as the `Center Director') 
        appointed by the President by and with the advice and consent 
        of the Senate.
            ``(2) Compensation.--The Center Director shall be 
        compensated at a rate that is the greater of--
                    ``(A) the average total compensation of the 
                directors of the national research institutes; or
                    ``(B) level IV of the Executive Schedule.
            ``(3) Duties of the center director.--The Center Director 
        shall perform functions as described under this subpart and as 
        the Secretary and the Director of NIH determine appropriate.
    ``(d) Associate Director.--
            ``(1) In general.--There shall be in the Center an 
        Associate Director for Biological, Chemical, Radiological, and 
        Infectious Disease Countermeasure Development (referred to in 
        this section as the `Associate Director'), who shall be 
        appointed by the Center Director.
            ``(2) Duties of the associate director.--The Associate 
        Director shall--
                    ``(A) serve as a liaison between the Department of 
                Health and Human Services, the National Institutes of 
                Health, the Department of Homeland Security, and the 
                Department of Defense on matters relating to the 
                development of biomedical technologies that enable 
                effective countermeasures to bioterror, chemical, and 
                radiological agents and infectious diseases;
                    ``(B) ensure that the National Institutes of Health 
                supports research that is consistent with, and 
                supportive of, the joint strategy for the development 
                of countermeasures for bioterror, chemical, and 
                radiological agents and infectious diseases of the 
                Department of Homeland Security, the Department of 
                Health and Human Services, and the Department of 
                Defense; and
                    ``(C) annually review the effectiveness of the 
                technology transfer policies and practices of the 
                National Institutes of Health with respect to the 
                development of countermeasures for bioterror, chemical, 
                and radiological agents and infectious diseases to 
                ensure that the policies and practices are consistent 
                with the joint countermeasure development strategy of 
                the Department of Homeland Security, the Department of 
                Health and Human Services, and the Department of 
                Defense.
    ``(e) Duties of the Center.--The Center shall--
            ``(1) manage the technology transfer, partnership, and 
        healthcare technology development programs at the National 
        Institutes of Health;
            ``(2) oversee the healthcare technology development 
        programs of the grantees of the National Institutes of Health;
            ``(3) secure and license intellectual property for research 
        performed at the National Institutes of Health;
            ``(4) prepare, on an annual basis, the National Healthcare 
        Technology Development Strategy regarding the technology 
        transfer, partnership, and healthcare technology development 
        programs of the National Institutes of Health and the grantees 
        of the National Institutes of Health;
            ``(5) with regard to the Healthcare Technology Development 
        Opportunities Assessments under section 492A--
                    ``(A) establish criteria for the contents of the 
                assessments;
                    ``(B) assist National Institutes of Health 
                applicants in preparing the assessments;
                    ``(C) assist the Directors of the national research 
                institutes in reviewing the assessments;
                    ``(D) prepare periodic analyses of the contents of 
                the assessments; and
                    ``(E) prepare periodic analyses of the extent to 
                which the opportunities were realized;
            ``(6) in consultation with the Directors of the national 
        research institutes, the National Advisory Council under 
        subsection (f) and the Institute Advisory Councils under 
        subsection (g), prepare a research agenda for the National 
        Institutes of Health, and for each national research institute, 
        that describes--
                    ``(A) the technology development opportunities and 
                the research that would be most beneficial to enhancing 
                the return on the investment of the Federal Government 
                in developing human diagnostics, therapeutics, 
                vaccines, and research tools, so that this investment 
                provides clinical benefits to individuals;
                    ``(B) the research supported by the Federal 
                Government that is complimentary to, and not 
                duplicative of or competitive with, private sector 
                research;
                    ``(C) proposed measures designed to speed the 
                development of human diagnostics, therapeutics, 
                vaccines, and research tools; and
                    ``(D) proposed measures designed to reduce the cost 
                and time necessary to develop human diagnostics, 
                therapeutics, vaccines, and research tools;
            ``(7) publish a technology transfer, partnership, and 
        healthcare technology development manual that describes the 
        most effective healthcare technology development policies and 
        practices for the National Institutes of Health and its 
        grantees that maximize the technology development opportunities 
        and the return on the investment of the Federal Government in 
        research to the development of healthcare technology;
            ``(8) collect and analyze comprehensive data regarding the 
        effectiveness of the technology transfer, partnerships, and 
        healthcare technology development programs of the National 
        Institutes of Health and its grantees that maximize the 
        technology development opportunities and the return on the 
        investment of the Federal Government in research to the 
        development of healthcare technology, including data 
        regarding--
                    ``(A) intellectual property;
                    ``(B) licensing and commercialization of inventions 
                sponsored by the National Institutes of Health;
                    ``(C) cooperative research and development 
                agreements; and
                    ``(D) technology development opportunities 
                assessments under section 492A(a);
            ``(9) develop guidelines that enable the National 
        Institutes of Health to accept and divest economic interests in 
        commercial entities that enter into technology transfer, 
        licensing, and partnership relationships with the National 
        Institutes of Health;
            ``(10) accept payment for services, use of equipment, 
        materials, or laboratory personnel, and retain or transfer 
        those funds to the appropriate laboratories;
            ``(11) ensure that Small Business Innovative Research 
        (SBIR) and Small Business Technology Transfer Program (STTR) 
        grants under section 9 of the Small Business Act (15 U.S.C. 
        638) are awarded to entities that have the greatest capacity to 
        develop healthcare technology that provides clinical benefits 
        to individuals;
            ``(12) oversee the review of SBIR and STTR grants;
            ``(13) annually award the `Birch Bayh and Robert Dole Award 
        for Healthcare Partnerships' to the individual and to the 
        organization that has made the most significant contribution 
        with regard to--
                    ``(A) maximizing the technology development 
                opportunities and the return on the investment of the 
                Federal Government in research related to the 
                development of human diagnostics, therapeutics, 
                vaccines, and research tools so that this investment 
                provides clinical benefits to individuals;
                    ``(B) ensuring that research supported by the 
                Federal Government is complimentary to, and not 
                duplicative of or competitive with, private sector 
                research;
                    ``(C) speeding the development of biomedical 
                research enabling human diagnostics, therapeutics, 
                vaccines, and research tools; and
                    ``(D) reducing the time and cost necessary to 
                develop human diagnostics, therapeutics, vaccines, and 
                research tools;
            ``(14) annually award the `Ronald Reagan and Morris Udall 
        Award for Healthcare Technology Development' to the individual 
        scientist supported by the National Institutes of Health that 
        has made the most significant contribution to the development 
        of healthcare technology that provides clinical benefits to 
        individuals;
            ``(15) provide grants to private organizations with 
        expertise in technology transfer, partnerships, and healthcare 
        technology development programs;
            ``(16) manage an education program for National Institutes 
        of Health and private sector entity employees and grantees on 
        the role of the National Institutes of Health concerning the 
        development of healthcare technology; and
            ``(17) manage the advisory councils under subsections (f) 
        and (g).
    ``(f) National Advisory Council.--
            ``(1) Establishment.--The Secretary shall establish in the 
        Center an advisory council to be known as the National 
        Healthcare Technology Development Advisory Council (referred to 
        in this subsection as the `National Advisory Council').
            ``(2) Composition.--
                    ``(A) In general.--The National Advisory Council 
                shall be composed of 13 members to be appointed in 
                accordance with subparagraph (B) and subject to 
                subparagraphs (C), (D), (E), and (F).
                    ``(B) Appointment; background.--
                            ``(i) Appointment.--Not later than 180 days 
                        after the effective date of the Project 
                        BioShield II Act of 2005, the Director of NIH 
                        shall appoint the members of the National 
                        Advisory Council.
                            ``(ii) Background.--Of the members 
                        appointed under clause (i)--
                                    ``(I) not less than 9 members shall 
                                be executive officers of biotechnology, 
                                pharmaceutical, diagnostic, and 
                                research tool companies that are 
                                currently developing or commercializing 
                                healthcare technology;
                                    ``(II) not less than 3 members 
                                shall be executive offices of small 
                                business interests; and
                                    ``(III) the remaining members may 
                                include investors and investment 
                                company executives, securities 
                                analysts, experts in the economics of 
                                biomedical research and development, 
                                experts in intellectual property and 
                                technology transfer, Food and Drug 
                                Administration regulations, licenses, 
                                partnerships, and technology transfer 
                                officers of grantees of the National 
                                Institutes of Health.
                    ``(C) Institute advisory councils.--A member of the 
                National Advisory Council shall not serve as a member 
                of an Institute Advisory Council under subsection (g).
                    ``(D) Ex officio members.--
                            ``(i) In general.--The Secretary of 
                        Commerce, the Director of the National Science 
                        Foundation, and the Director of the National 
                        Institute of Standards and Technology shall 
                        serve as ex officio members of the National 
                        Advisory Council.
                            ``(ii) Designees.--The officers listed in 
                        clause (i) may appoint a designee to perform 
                        their functions on the National Advisory 
                        Council.
                    ``(E) Chairperson.--The Director of NIH shall 
                appoint a chairperson of the National Advisory Council 
                from among the council members.
                    ``(F) Vacancy.--Any vacancy in the National 
                Advisory Council shall not affect the powers of the 
                Council and shall be filled in the same manner as the 
                original appointment.
            ``(3) Duties of the national advisory council.--The 
        National Advisory Council shall advise the Center Director 
        regarding policies and procedures that will--
                    ``(A) maximize the technology development 
                opportunities and the return on the investment of the 
                Federal Government in research related to the 
                development of human diagnostics, therapeutics, 
                vaccines, and research tools so that this investment 
                provides clinical benefits to individuals;
                    ``(B) ensure that research supported by the Federal 
                Government is complimentary to, and not duplicative of 
                or competitive with, private sector research;
                    ``(C) speed the development of biomedical research 
                into effective human diagnostics, therapeutics, 
                vaccines, and research tools; and
                    ``(D) reduce the cost and time needed for the 
                development of human diagnostics, therapeutics, 
                vaccines, and research tools.
            ``(4) Powers.--
                    ``(A) Hearings.--The National Advisory Council may 
                hold such hearings, sit and act at such times and 
                places, take such testimony, and receive such evidence 
                as the National Advisory Council considers advisable to 
                carry out this section.
                    ``(B) Information from federal agencies.--The 
                National Advisory Council may secure directly from any 
                Federal department or agency such information as the 
                National Advisory Council considers necessary to carry 
                out the provisions of this section. Upon request of the 
                National Advisory Council, the head of such department 
                or agency shall furnish such information to the 
                National Advisory Council.
                    ``(C) Postal services.--The National Advisory 
                Council may use the United States mails in the same 
                manner and under the same conditions as other 
                departments and agencies of the Federal Government.
            ``(5) Personnel.--
                    ``(A) Travel expenses.--The members of the National 
                Advisory Council shall not receive compensation for the 
                performance of services for the National Advisory 
                Council, but shall be allowed travel expenses, 
                including per diem in lieu of subsistence, at rates 
                authorized for employees of agencies under subchapter I 
                of chapter 57 of title 5, United States Code, while 
                away from their homes or regular places of business in 
                the performance of services for the National Advisory 
                Council. Notwithstanding section 1342 of title 31, 
                United States Code, the Secretary may accept the 
                voluntary and uncompensated services of members of the 
                National Advisory Council.
                    ``(B) Detail of government employees.--Any Federal 
                Government employee may be detailed to the National 
                Advisory Council without reimbursement, and such detail 
                shall be without interruption or loss of civil service 
                status or privilege.
    ``(g) Institute Advisory Councils.--
            ``(1) Establishment.--The Secretary shall establish in the 
        Center the National Center for Healthcare Technology 
        Development Institute Advisory Councils (referred to in this 
        subsection as the `Institute Advisory Councils').
            ``(2) Composition.--
                    ``(A) In general.--Each Institute Advisory Council 
                shall be composed of 13 members appointed in accordance 
                with subparagraph (B) and subject to subparagraphs (C), 
                (D), (E), and (F).
                    ``(B) Appointment; background.--
                            ``(i) Appointment.--Not later than 180 days 
                        after the effective date of the Project 
                        BioShield II Act of 2005, the appropriate 
                        Institute Director shall appoint the members of 
                        the respective Institute Advisory Council.
                            ``(ii) Background.--Of the members 
                        appointed under clause (i)--
                                    ``(I) at least 9 members shall be 
                                executive officers of biotechnology, 
                                pharmaceutical, diagnostic, and 
                                research tool companies that are 
                                currently developing or commercializing 
                                healthcare technology; and
                                    ``(II) the remaining members shall 
                                include investors and investment 
                                company executives, securities 
                                analysts, experts in the economics of 
                                biomedical research and development, 
                                experts in intellectual property and 
                                technology transfer, Food and Drug 
                                Administration regulations, licenses, 
                                partnerships, and technology transfer 
                                officers of grantees of the National 
                                Institutes of Health.
                    ``(C) National advisory council.--A member of an 
                Institute Advisory Council shall not serve as a member 
                of the National Advisory Council under subsection (f).
                    ``(D) Ex officio member.--The Center Director, or 
                his or her designee, shall serve as an ex officio 
                member of the Institute Advisory Councils.
                    ``(E) Chairperson.--The appropriate Institute 
                Director shall appoint a chairperson of the respective 
                Institute Advisory Council from among the council 
                members.
                    ``(F) Vacancies.--Any vacancy in an Institute 
                Advisory Council shall not affect the powers of the 
                Council and shall be filled in the same manner as the 
                original appointment.
            ``(3) Duties of the institute advisory council.--The 
        Institute Advisory Councils shall advise the Center Director 
        regarding policies and procedures that will--
                    ``(A) maximize the technology development 
                opportunities and the return on the investment of the 
                Federal Government in research related to the 
                development of human diagnostics, therapeutics, 
                vaccines, and research tools so that this investment 
                provides clinical benefits to individuals;
                    ``(B) ensure that research supported by the Federal 
                Government is complimentary to, and not duplicative of 
                or competitive with, private sector research;
                    ``(C) speed the development of biomedical research 
                into human diagnostics, therapeutics, vaccines, and 
                research tools; and
                    ``(D) reduce the cost and time needed for the 
                development of human diagnostics, therapeutics, 
                vaccines, and research tools.
            ``(4) Powers.--
                    ``(A) Hearings.--The Institute Advisory Councils 
                may hold such hearings, sit and act at such times and 
                places, take such testimony, and receive such evidence 
                as the Institute Advisory Council considers advisable 
                to carry out this section.
                    ``(B) Information from federal agencies.--The 
                Institute Advisory Councils may secure directly from 
                any Federal department or agency such information as 
                the Institute Advisory Council considers necessary to 
                carry out the provisions of this section. Upon request 
                of an Institute Advisory Council, the head of such 
                department or agency shall furnish such information to 
                the Institute Advisory Council.
                    ``(C) Postal services.--The Institute Advisory 
                Councils may use the United States mails in the same 
                manner and under the same conditions as other 
                departments and agencies of the Federal Government.
            ``(5) Personnel.--
                    ``(A) Travel expenses.--The members of the 
                Institute Advisory Councils shall not receive 
                compensation for the performance of services for the 
                Institute Advisory Councils, but shall be allowed 
                travel expenses, including per diem in lieu of 
                subsistence, at rates authorized for employees of 
                agencies under subchapter I of chapter 57 of title 5, 
                United States Code, while away from their homes or 
                regular places of business in the performance of 
                services for the Institute Advisory Councils. 
                Notwithstanding section 1342 of title 31, United States 
                Code, the Secretary may accept the voluntary and 
                uncompensated services of members of the Institute 
                Advisory Council.
                    ``(B) Detail of government employees.--Any Federal 
                Government employee may be detailed to an Institute 
                Advisory Council without reimbursement, and such detail 
                shall be without interruption or loss of civil service 
                status or privilege.
    ``(h) Traineeships; Fellowships.--
            ``(1) In general.--The Secretary, acting through the Center 
        Director, may--
                    ``(A) provide research training and instruction in 
                technology transfer and healthcare commercialization 
                transfer, licenses, partnerships, and healthcare 
                technology development; and
                    ``(B) establish research traineeships and 
                fellowships in technology transfer and healthcare 
                commercialization.
            ``(2) Stipends and allowances.--The Secretary may provide 
        individuals receiving instruction, a traineeship, or fellowship 
        under paragraph (1) with such stipends and allowances, 
        including amounts for travel, subsistence, and dependents, as 
        the Secretary determines necessary.
            ``(3) Employee detail.--The Secretary shall establish 
        guidelines for the temporary leave, for a period of not to 
        exceed 3 years, of not more than 220 employees of the National 
        Institutes of Health, to appropriate for-profit organizations 
        that are in the business of developing human therapeutics, 
        vaccines, devices, or diagnostics and research tools.
    ``(i) Grants.--
            ``(1) In general.--The Secretary, acting through the Center 
        Director, shall award grants to eligible nonprofit institutions 
        to provide training, instruction, traineeships, and fellowships 
        under subsection (h).
            ``(2) Use of funds.--A nonprofit institution that receives 
        funds under this subsection shall use the amounts provided 
        through the grant to provide training, instruction, 
        traineeships, and fellowships to individuals under subsection 
        (h) with regard to technology transfer and healthcare 
        development.
            ``(3) Eligibility.--To be eligible for a grant under this 
        subsection, a nonprofit institution shall submit an application 
        to the Secretary in such form, in such manner, and containing 
        such information as the Secretary may require.
    ``(j) Authorization of Appropriations.--There is authorized to be 
appropriated an amount equal to 0.3 percent of the amount obligated by 
the National Institutes of Health in fiscal year 2004 for each fiscal 
year to carry out this section.''.
    (b) Government Discount.--The Secretary of Health and Human 
Services and the Secretary of Veterans Affairs shall ensure that the 
price that the Federal Government pays for a drug, biological product, 
human therapeutic, vaccine, or diagnostic developed using technology 
licensed by the National Institutes of Health does not include 
reimbursement for any royalty rate previously paid by the technology 
partner or its assign.

SEC. 1603. TECHNOLOGY DEVELOPMENT OPPORTUNITIES ASSESSMENTS.

    Section 492A(a) of the Public Health Service Act (42 U.S.C. 289a-
1(a)) is amended by adding at the end the following:
            ``(3) Technology development opportunities assessment.--
        Each proposal submitted to the National Institutes of Health 
        shall include an assessment, prepared in compliance with the 
        guidelines developed by the National Center for Healthcare 
        Technology Development, of technology development 
        opportunities, including opportunities that may exist for the 
        proposed research to--
                    ``(A) maximize the technology development 
                opportunities and the return on the investment of the 
                Federal Government in research related to the 
                development of human diagnostics, therapeutics, 
                vaccines, and research tools so that this investment 
                provides clinical benefits to individuals;
                    ``(B) ensure that research supported by the Federal 
                Government is complimentary to, and not duplicative of 
                or competitive with, private sector research;
                    ``(C) speed the development of biomedical research 
                into human diagnostics, therapeutics, vaccines, and 
                research tools; and
                    ``(D) reduce the cost and time necessary for the 
                development of human diagnostics, therapeutics, 
                vaccines, and research tools.''.

SEC. 1604. RESOURCES FOR THE NATIONAL CENTER FOR HEALTHCARE TECHNOLOGY 
              DEVELOPMENT.

    Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) 
is amended--
            (1) in paragraph (13)(B), by striking ``and'';
            (2) in paragraph (14), by striking ``title 38, United 
        States Code.'' and inserting ``title 38, United States Code; 
        and''; and
            (3) inserting after paragraph (14) the following:
            ``(15) after consultation with the Director of the National 
        Center for Healthcare Technology Development, shall develop 
        programs designed to--
                    ``(A) maximize the technology development 
                opportunities and the return on the investment of the 
                Federal Government in research related to the 
                development of human diagnostics, therapeutics, 
                vaccines, and research tools so that this investment 
                provides clinical benefits to individuals;
                    ``(B) ensure that research supported by the Federal 
                Government is complimentary to, and not duplicative of 
                or competitive with, private sector research;
                    ``(C) speed the development of biomedical research 
                into human diagnostics, therapeutics, vaccines, and 
                research tools; and
                    ``(D) reduce the time and cost necessary for the 
                development of human diagnostics, therapeutics, 
                vaccines, and research tools.''.

SEC. 1605. BIENNIAL REPORT OF THE DIRECTOR OF THE NATIONAL INSTITUTES 
              OF HEALTH TO THE PRESIDENT AND CONGRESS.

    Section 403 of the Public Health Service Act (42 U.S.C. 283) is 
amended--
            (1) in paragraph (4), by striking ``area; and'' and 
        inserting ``area;'';
            (2) in paragraph (5), by striking ``Nursing Research.'' and 
        inserting ``Nursing Research; and''; and
            (3) by inserting after (5) the following:
            ``(6) a description of the healthcare technology that has 
        been developed for the clinical benefit of individuals with 
        support by the National Institutes of Health in the preceding 
        2-year period and the specific contribution of research 
        supported by the National Institutes of Health to this 
        technology.''.

SEC. 1606. AUTHORITY OF THE DIRECTORS OF THE NATIONAL RESEARCH 
              INSTITUTES; BIENNIAL REPORT.

    (a) Authority of the Directors of the National Research 
Institutes.--Section 405(b)(1)(A) of the Public Health Service Act (42 
U.S.C. 284(b)(1)(A)) is amended--
            (1) in clause (iii), by striking ``disabilities, and'' and 
        inserting ``disabilities,'';
            (2) in clause (iv), by striking ``the environment;'' and 
        inserting ``the environment, and''; and
            (3) by inserting after clause (iv) the following:
                    ``(v) the expansion of knowledge of the creation, 
                manufacture, or administration of treatments of 
                patients suffering from diseases, disorders, or 
                disabilities; and''.
    (b) Biennial Report.--Section 407 of the Public Health Service Act 
(42 U.S.C. 284b) is amended to read as follows:

``SEC. 407. INSTITUTE BIENNIAL REPORT.

    ``(a) In General.--The Director of each national research 
institute, after consultation with the advisory council for the 
institute, shall include in the biennial report made under section 
403--
            ``(1) a description of the research areas identified as 
        most relevant to the development of technology by the National 
        Center for Healthcare Technology Development Advisory Council;
            ``(2) a description of the activities of the institute;
            ``(3) a description of technology that has been developed 
        and licensed for the clinical benefit of individuals from all 
        research supported by the institute; and
            ``(4) a description of program policies of the Director of 
        the institute.
    ``(b) Additional Reports.--The Director of each national research 
institute may prepare such additional reports as the Director 
determines appropriate.
    ``(c) Opportunity for Written Comments.--The Director of each 
national research institute shall provide the advisory council for the 
institute an opportunity for the submission of the written comments 
described under section 406(g).''.

SEC. 1607. COMMERCIAL RESEARCH AND INVESTIGATIONS.

    Section 301(a) of the Public Health Service Act (42 U.S.C. 241(a)) 
is amended in the matter following paragraph (8) by striking ``for 
biomedical and behavioral research, substances and living organisms'' 
and inserting ``for commercial, biomedical, and behavioral research, 
substances, resources, rights to intellectual property, and living 
organisms''.

SEC. 1608. SBIR/STTR PROGRAM CONSULTATION WITH THE DIRECTOR OF THE 
              CENTER OF HEALTHCARE TECHNOLOGY DEVELOPMENT.

    Section 9 of the Small Business Act (15 U.S.C. 638) is amended--
            (1) in subsection (g)(3)--
                    (A) in subparagraph (A), by striking ``; or'' and 
                inserting a semicolon;
                    (B) in subparagraph (B), by inserting ``or'' after 
                the semicolon; and
                    (C) by adding after subparagraph (B) the following:
                    ``(C) the Director of the National Center for 
                Healthcare Technology Development under section 485K of 
                the Public Health Service Act;''; and
            (2) in subsection (o)(3)--
                    (A) in subparagraph (A), by striking ``; or'' and 
                inserting a semicolon;
                    (B) in subparagraph (B), by inserting ``or'' after 
                the semicolon; and
                    (C) by inserting after subparagraph (B) the 
                following:
                    ``(C) by the Director of the National Center for 
                Healthcare Technology Development under section 485K of 
                the Public Health Service Act;''.

SEC. 1609. PURPOSE OF THE NATIONAL RESEARCH INSTITUTES.

    Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) 
is amended--
            (1) in section 410 (42 U.S.C. 285), by inserting before the 
        period the following: ``, and the conduct and support of the 
        development of healthcare technologies'';
            (2) in section 418 (42 U.S.C. 285b), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (3) in section 426 (42 U.S.C. 285c), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (4) in section 435 (42 U.S.C. 285d), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (5) in section 443 (42 U.S.C. 285e), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (6) in section 446 (42 U.S.C. 285f), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (7) in section 448 (42 U.S.C. 285g), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (8) in section 453 (42 U.S.C. 285h), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (9) in section 455 (42 U.S.C. 285i), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (10) in section 457 (42 U.S.C. 285j), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (11) in section 461 (42 U.S.C. 285k), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (12) in section 463 (42 U.S.C. 285l), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (13) in section 464 (42 U.S.C. 285m), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (14) in section 464H (42 U.S.C. 284n), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (15) in section 464L (42 U.S.C. 285o), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (16) in section 464R (42 U.S.C. 285p), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies'';
            (17) in section 464V (42 U.S.C. 285q), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies''; and
            (18) in section 464Z (42 U.S.C. 285r), by inserting before 
        the period the following: ``, and the conduct and support of 
        the development of healthcare technologies''.

SEC. 1610. CONFORMING AMENDMENT.

    Section 401(b)(1) of the Public Health Service Act (42 U.S.C. 
281(b)(1)) is amended by adding at the end the following:
            ``(S) The National Center for Healthcare Technology 
        Development.''.

SEC. 1611. EFFECTIVE DATE.

    This title shall take effect on October 1, 2005, or upon the date 
of enactment of this title, whichever occurs later.

   Subtitle B--Protecting Government Investment in Basic Biomedical 
                                Research

SEC. 1621. FINDINGS.

    Congress finds that--
            (1) the rate of return on the Federal Government's 
        investment in basic biomedical research is maximized when the 
        intellectual property for that research is effectively 
        transferred to commercial entities for development into 
        healthcare products for the benefit of patients;
            (2) intellectual property for research supported by the 
        National Institutes of Health is often not competitive with 
        intellectual property for research supported by private 
        investors due to inefficiencies of the technology transfer 
        process and the consequent erosion of the term of the patents 
        for the technology; and
            (3) to protect the Federal Government's investment in basic 
        biomedical research and to maximize the likelihood that 
        technology will be developed into healthcare products, a patent 
        that is not affected by the inefficiencies in the technology 
        transfer process should be granted.

SEC. 1622. UTILIZATION AND AVAILABILITY.

    (a) In General.--An entity with respect to which an affirmative 
determination is made under section 301(b)(4) shall maximize the 
utilization of a research tool involved for the development of 
countermeasures, including making the research tool available on 
commercially reasonable terms to other entities certified under section 
301(b)(4) to develop countermeasures.
    (b) Rule of Construction.--Nothing in this title or chapter 18 of 
title 35, United States Code, shall be construed to restrict the right 
of an entity described in subsection (a) to--
            (1) secure and enforce a patent regarding a research tool;
            (2) enter into exclusive, revocable, and nontransferable 
        licenses of a research tool; or
            (3) impose limits on royalty- or product- reach-through or 
        downstream rights or agreements on future countermeasures, or 
        option rights with respect to a research tool.

SEC. 1623. RESTORATION OF TERM OF UNEXPLOITED PATENTS ON GOVERNMENT 
              SPONSORED INVENTIONS RELATING TO COUNTERMEASURES.

    (a) In General.--Chapter 14 of title 35, United States Code, is 
amended by adding at the end the following:
``Sec. 159. Patent term restoration for unexploited patents on 
              Government sponsored inventions
    ``(a) Definitions.--In this section:
            ``(1) Eligible government-sponsored invention.--The term 
        `eligible Government-supported invention' means an invention 
        supported in part by funds appropriated to the National 
        Institutes of Health that may be used to produce a 
        countermeasure to a terror agent, infectious disease or other 
        disease or condition or is subject to the provisions of chapter 
        18 of title 35, United States Code.
            ``(2) Eligible government patent.--The term `eligible 
        Government patent' means a patent that--
                    ``(A) claims an eligible Government-supported 
                invention;
                    ``(B) has not been extended or restored under 
                section 156, 156a, or 158; and
                    ``(C) has not been licensed prior to a date that is 
                2 years before the date the patent will expire.
            ``(3) Effective exploitation of date of the patent.--The 
        term `effective exploitation date of the patent' means the date 
        that is the later of--
                    ``(A) the date that the patent is licensed to an 
                entity that is not a Federal agency, as that term is 
                defined in section 201(a), for purposes of development 
                or commercialization of the patented invention; or
                    ``(B) if the patent claims a product, a method of 
                using a product or a method of using a product as 
                defined in section 156(a), the date that such product 
                is approved under section 505(b)(1) of the Federal Food 
                Drug and Cosmetic Act (21 U.S.C. 355(b)(1)) or under 
                section 351 of the Public Health Service Act (42 U.S.C. 
                262).
    ``(b) Patent Term Restoration for Eligible Government Patents.--
            ``(1) In general.--Notwithstanding the provisions of 
        section 154, the term of an eligible Government patent shall be 
        restored by a period equal to the number of days starting on 
        the date that the patent is issued and ending on the date of 
        effective exploitation date of the patent.
            ``(2) Limitation.--No eligible Government patent shall be 
        restored under this section unless--
                    ``(A) the Director of the National Institutes of 
                Health (referred to in this section as the `Director of 
                NIH') determines that the licensing of such patent will 
                assist in the development of countermeasures, 
                medicines, vaccines, and other technology potentially 
                beneficial to patients; and
                    ``(B) prior to the expiration of the patent, the 
                Director of NIH submits an application to the Director 
                to restore the term of the patent under subsection (c).
    ``(c) Procedure for Restoring Term of Eligible Government Patent.--
            ``(1) In general.--The Director of NIH shall request 
        restoration of an eligible Government patent by submitting a 
        written application to the Director.
            ``(2) Contents of application.--An application under this 
        section shall--
                    ``(A) be sent to the Director prior to the date 
                that is 45 days before the patent expires;
                    ``(B) set forth the period of the restoration 
                requested; and
                    ``(C) provide an explanation of the basis of the 
                conclusion of the Director of NIH that the requirements 
                of subparagraph (A) are met with respect to the patent 
                being restored.
            ``(3) Effect of section.--The Director of NIH shall 
        promulgate regulations to give effect to this section, 
        including procedures that permit the restoration of patents in 
        respect of which title has been transferred under section 202.
    ``(d) Deferral of Payment of Patent Issue Fees for Eligible 
Government Patents.--The Federal agency that has rights in an invention 
subject to a patent application under chapter 18 may defer the payment 
of fees under section 41 due for issuance of an eligible Government 
patent until the date that is 90 days after the date that the patent 
been licensed to an entity that is not a Federal agency as that term is 
defined in section 201(a). Not later than 30 days after the date a 
notice of allowance of the patent application is mailed by the 
Director, the applicant shall inform the Director that it is invoking 
this section with respect to the application. The Director shall issue 
the patent for the National Institutes of Health-supported technology 
notwithstanding the non-payment of the issue fee, subject to the 
provisions of this section.
    ``(e) Procedures Applicable to Patent Term Restoration 
Applications.--The Director has the authority to accept an application 
submitted under this section and sections 156, 156a, and 158 after the 
date specified in such sections in exceptional circumstances or where 
good cause is shown for the delay in submitting the application, except 
no application may be accepted under any of these sections more than 30 
days after the date specified in such section.
    ``(f) Rules of Construction Regarding Research Tools.--Nothing in 
this section or chapter 18 of title 35, United States Code, shall be 
construed to restrict the right of an entity to--
                            ``(i) secure and enforce patents with 
                        regard to research tools;
                            ``(ii) enter into exclusive, revocable, and 
                        nontransferable licenses of such research 
                        tools; or
                            ``(iii) impose limits on royalty- or 
                        product-reach-through or downstream rights or 
                        agreements on future countermeasures or 
                        products, or option rights with respect to a 
                        research tool.''.
    (d) Discretionary Waiver of March-In Rights and Exclusive 
Licensing.--
            (1) In general.--The owner of a patent over which the 
        Government has rights under chapter 18 of title 35, United 
        States Code, may request that a Federal agency under whose 
        funding a subject invention was made may waive rights the 
        Government has under sections 200, 203, and 209 of title 35, 
        United States Code.
            (2) Requests.--If a request under paragraph (1) is made 
        within 90 days after the date that the entity obtained title to 
        the patent, the Federal agency shall grant the request.
            (c) Federally owned inventions.--Section 209 of title 35, 
        United States Code, (as amended by section 301) is amended--
                    (A) by redesignating subsections (f) and (g) as 
                subsections (g) and (h), respectively; and
                    (B) by inserting after subsection (e) the 
                following:
    ``(f) Terms and Conditions of Exclusive License.--Each exclusive 
license granted shall include a provision that, at the discretion of 
the licensee, the licensee may act as the agent for the licensor with 
respect to any patent for the licensed invention for purposes of 
extending a patent under section 156a or 158.''.
    (d) Technical and Conforming Amendment.--The table of sections for 
chapter 14 of title 35, United States Code, is amended by adding after 
the item relating to section 158 the following:

        ``159. Patent term restoration for unexploited patents on 
                            Government sponsored inventions.''.

SEC. 1624. ENCOURAGING THE PATENTING OF RESEARCH TOOLS.

    Section 200 of title 35, United States Code, is amended by striking 
``enterprise without unduly encumbering future research and discovery'' 
and inserting ``enterprise''.

SEC. 1625. EFFECTIVE DATE.

    This title takes effect on October 1, 2005, or upon the date of 
enactment of this title, whichever occurs later.

                Subtitle C--Partnership Challenge Grants

SEC. 1631. PARTNERSHIP CHALLENGE GRANTS.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) (as amended by sections 202, 1901, 2101, 2102, and 1401) is 
amended by inserting after section 319F-7 (as added by section 1401) 
the following:

``SEC. 319F-8. NATIONAL INSTITUTES OF HEALTH COUNTERMEASURES 
              PARTNERSHIP CHALLENGE GRANTS.

    ``(a) Grants Authorized.--The Director of the National Institutes 
of Health (in this section referred to as the `Director'), in 
consultation with the Director of the Centers for Disease Control and 
Prevention, is authorized to award, in consultation with the Foundation 
for the National Institutes of Health, partnership challenge grants to 
promote joint ventures between the National Institutes of Health, the 
Foundation for the National Institutes of Health, its grantees, 
qualified clinical countermeasures delivery centers, and for-profit 
biotechnology, pharmaceutical, and medical device industries for the 
development of countermeasures and research tools.
    ``(b) Regulations.--The Director shall issue regulations within 90 
days of the date of enactment of this section to implement the awarding 
of grants under subsection (a).
    ``(c) Rule of Construction.--Nothing in this section shall be 
construed to preclude an entity that receives a partnership challenge 
grant under this section from also being certified as being eligible 
for the tax, procurement, intellectual property, and liability 
incentives provided for under the amendments made by subtitle A of 
title III of the Project BioShield II Act of 2005.
    ``(d) Safety Training Program.--The Director of NIH, in 
consultation with the Director of the Centers for Disease Control and 
Prevention, shall establish a safety training program for researchers 
working in biosafety level 3 or 4 facilities.
    ``(e) Transfer of Funds.--The Director is authorized to transfer 
funds to the Foundation for the National Institutes of Health to be 
used for partnership grants and other costs associated with 
administering this section.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary for each of fiscal years 
2004, 2005, 2006, 2007, and 2008 for the purpose of carrying out this 
section.''

TITLE XVII--DEVELOPMENT OF COUNTERMEASURE RESEARCH AT THE DEPARTMENT OF 
                                DEFENSE

SEC. 1701. DEVELOPMENT OF COUNTERMEASURE RESEARCH AT THE DEPARTMENT OF 
              DEFENSE.

    There are authorized to be appropriated to the Department of Health 
and Human Services, including funds appropriated under the Project 
BioShield Act of 2004 and this Act, such sums as may be necessary to 
secure and facilitate the development of countermeasures, as defined in 
section 319F-3 of the Public Health Service Act (as added by section 
202), and infectious disease research at the Department of Defense.

SEC. 1702. REQUEST BY THE DEPARTMENT OF DEFENSE.

    (a) In General.--Upon request by the Secretary of Defense, the 
Secretary of Health and Human Services may establish interagency 
agreements, under terms acceptable to the Secretary of Health and Human 
Services, in which the Department of Defense may order countermeasures 
under procurement contracts or procurement pools established by the 
Secretary of Health and Human Services.
    (b) Processing of Orders.--The ordering of a countermeasure under 
an agreement under subsection (a) (including transfers of appropriated 
funds between the Department of Defense and the Department of Health 
and Human Services to pay for such orders) may be conducted pursuant to 
section 1535 of title 31, United States Code, if such order is 
processed under the terms established--
            (1) by the Secretary in the interagency agreement described 
        under subsection (a) for all other orders; and
            (2) in the Project BioShield Act of 2004 and the Project 
        BioShield II Act of 2005 (and the amendments made by such Acts) 
        with respect to the procurement of countermeasures under 
        section 319F-2 and section 319F-1 of the Public Health Service 
        Act.

SEC. 1703. EXPANDED PUBLIC-PRIVATE PARTNERSHIP AGREEMENTS FOR RESEARCH 
              AND DEVELOPMENT.

    (a) Cooperative Research and Development Agreements.--
            (1) Authority.--In order to develop countermeasures and 
        research tools, the Secretary of Defense may--
                    (A) authorize the directors or commanders of 
                laboratories and technical activities to enter into 
                agreements under section 3710a of title 15, United 
                States Code; and
                    (B) subject to requirements analogous to those 
                governing the licensing of federally owned inventions 
                under section 209 of title 35, United States Code, 
                grant nonexclusive, exclusive, or partially exclusive 
                licenses, royalty-free or for royalties or other 
                consideration, for computer software developed at a 
                laboratory or technical activity that would, if the 
                information involved were obtained from a non-Federal 
                source, constitute a trade secret or commercial or 
                financial information that is privileged or 
                confidential under the meaning of section 552(b)(4) of 
                title 5, United States Code.
            (2) Protection of software.--The Secretary of Defense shall 
        provide appropriate precautions against the unlicensed 
        dissemination of any software licensed under paragraph (1)(B), 
        including exemption from subchapter II of chapter 5 of title 5, 
        United States Code (commonly known as the Administrative 
        Procedure Act), for a period of up to 5 years after the 
        development of the software by the laboratory or technical 
        activity.
    (b) Royalties.--
            (1) In general.--Except as provided in paragraph (2), any 
        royalties or other payments received by the Department of 
        Defense from licensing computer software under subsection 
        (a)(1)(B) shall be disposed of as follows:
                    (A) The Department may provide appropriate 
                incentives, from royalties or other payments, to 
                laboratory and technical activity employees who are not 
                developers of such computer software but who 
                substantially increased the technical value of the 
                software.
                    (B) The Department shall retain the royalties and 
                other payments received until the Department or the 
                laboratory or technical activity involved makes 
                payments to employees of a laboratory or technical 
                activity under subparagraph (A).
                    (C) The balance of the royalties or other payments 
                shall be transferred by the Department of Defense to 
                the accounts of any of its laboratories and technical 
                activities, with the majority share of the royalties or 
                other payments from any invention going to the account 
                of the laboratory or technical activity responsible for 
                the invention. The royalties or other payments so 
                transferred may be used or obligated by a laboratory or 
                technical activity during the fiscal year in which they 
                are received or during the 2 succeeding fiscal years--
                            (i) to reward scientific, engineering, and 
                        technical employees of the laboratory or 
                        technical activity, including developers of 
                        sensitive or classified technology, regardless 
                        of whether the technology has commercial 
                        applications;
                            (ii) to further scientific exchange among 
                        the laboratories and technical activities of 
                        the Department;
                            (iii) for education and training of 
                        employees consistent with the research and 
                        development missions and objectives of the 
                        Department or the laboratory or technical 
                        activity, and for other activities that 
                        increase the potential for transfer of the 
                        technology of the laboratories and technical 
                        activities;
                            (iv) for payment of expenses incidental to 
                        the administration and licensing of computer 
                        software or other intellectual property made at 
                        that laboratory or technical activity, 
                        including the fees or other costs for the 
                        services of other agencies, persons, or 
                        organizations for intellectual property 
                        management and licensing services; or
                            (v) for scientific research and development 
                        consistent with the research and development 
                        missions and objectives of the laboratory or 
                        technical activity.
                    (D) All royalties or other payments retained by the 
                Department or laboratory or technical activity after 
                payments have been made pursuant to subparagraphs (A), 
                (B), and (C) that are unobligated and unexpended at the 
                end of the second fiscal year succeeding the fiscal 
                year in which the royalties and other payments were 
                received shall be paid into the Treasury of the United 
                States.
            (2) Excess payments.--If, after payments to employee-
        developers under paragraph (1), the royalties or other payments 
        received by the Department of Defense in any fiscal year exceed 
        5 percent of the budget of the Department for that year, 75 
        percent of such excess shall be paid to the Treasury of the 
        United States and the remaining 25 percent may be used or 
        obligated as described in paragraph (1)(C). Any funds not so 
        used or obligated shall be paid into the Treasury of the United 
        States.
            (3) Treatment of payments.--Any payment made to an employee 
        under this subsection shall be in addition to the regular pay 
        of the employee and to any other awards made to the employee, 
        and shall not affect the entitlement of the employee to any 
        regular pay, annuity, or award to which such employee is 
        otherwise entitled or for which such employee is otherwise 
        eligible or limit the amount thereof. Any such payment made to 
        an employee-developer shall continue after the developer leaves 
        the laboratory or technical activity or the Department. 
        Payments made under this section shall not exceed $150,000 per 
        year to any one person, unless the President approves a larger 
        award (with the amount in excess of $150,000 being treated as a 
        Presidential award under section 4504 of title 5, United States 
        Code).
    (c) Regulations.--The Secretary of Defense shall promulgate 
regulations implementing this section.
    (d) Information in Report.--The report required under section 
2515(d) of title 10, United States Code, shall include information 
regarding the implementation and effectiveness of this section.
    (e) Laboratory and Technical Activity Defined.--As used in this 
section, the terms ``laboratory'' and ``technical activity'' mean any 
facility or group of facilities that is owned, leased, operated, or 
otherwise used by the Department of Defense to perform research, 
development, engineering, testing, or evaluation. The term includes 
Department of Defense universities, depots, logistics centers, test 
centers, shipyards, arsenals, or similar organizations that perform 
these activities in any capacity consistent with their missions, 
regardless of whether such activities are a primary or substantial 
element of such missions. This definition also shall be used by 
Department of Defense entities when entering into cooperative research 
and development agreements under section 3710a of title 15, United 
States Code.
    (f) Effective Date and Expiration.--The authority provided for in 
this section is for a pilot program to test the effectiveness of this 
authority and shall expire on December 31, 2009.

            TITLE XVIII--MILLENNIUM MEDICINE DISCOVERY AWARD

SEC. 1801. MILLENNIUM MEDICINE DISCOVERY AWARD.

    Part P of title III of the Public Health Service Act (42 U.S.C. 280 
et seq.) is amended by adding at the end the following:

``SEC. 3990. MILLENNIUM MEDICINE DISCOVERY AWARD.

    ``(a) Establishment of Award.--There is established an award to be 
known as the Millennium Medicine Discovery Award (referred to in the 
section as the `Award').
    ``(b) Purpose of Award.--The Secretary shall present the Award to 
an individual, institution of higher learning (as defined in section 
101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)), or 
commercial entity that--
            ``(1) discovers a vaccine or therapeutic that cures or 
        prevents AIDS;
            ``(2) discovers a vaccine or therapeutics that prevents 
        infection from malaria;
            ``(3) discovers a new class of anti-microbials; or
            ``(4) attains another achievement in infectious disease 
        research as determined by the Secretary.
    ``(c) Regulations.--
            ``(1) In general.--The Secretary shall by regulation 
        establish the medical discoveries for which the Award may be 
        conferred, the amount of the award, and the application process 
        for the Award.
            ``(2) Limitation.--The amount of an Award under this 
        section, which shall be in the form of cash, shall not exceed 
        $100,000,000 per discovery.
    ``(d) Examples of Discoveries.--Discoveries that may qualify for an 
Award under this section may include 1 of the following:
            ``(1) An oral vaccine delivery system, or needle-free 
        system, that provides primary immunization against bioterrorism 
        agents, infectious disease, or significant diseases of the 
        developing world.
            ``(2) A new adjuvant for vectored or recombinant DNA 
        vaccines that induce and sustain both cellular and humeral 
        responses in humans that is directed at bioterrorism agents, 
        infectious diseases, or significant diseases of the developing 
        world.
            ``(3) A vaccine that provides lifelong protection against 
        HIV-1 infection, or a vaccine that lessens the viral load in 
        those immunized people who become infected or that delays the 
        clinical progression of disease and decreases transmission of 
        the virus through the immunized population.
            ``(4) A microbicide that prevents or significantly reduces 
        HIV transmission and other infections. In this paragraph, the 
        term `microbicide' means a range of products, including those 
        products in gel, cream, film, ring, or suppository form that, 
        when applied topically, prevent HIV transmission and other 
        sexually transmitted diseases.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this section. 
The Secretary shall secure \1/2\ of the funding for the Awards under 
this section from other entities, including nonprofit institutions.''.

                TITLE XIX--FOOD AND DRUG ADMINISTRATION

SEC. 1901. OTHER INCENTIVES.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 319F-3 (as added by 
section 202) the following:

``SEC. 319F-4. ACCELERATED APPROVAL OF COUNTERMEASURES.

    ``(a) In General.--The Secretary may designate a countermeasure as 
a fast-track product pursuant to section 506 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356) or as a device granted priority review 
pursuant to section 515(d)(5) of such Act (21 U.S.C. 366e(d)(5)). Such 
a designation may be made prior to the submission of--
            ``(1) a request for designation by the sponsor or 
        applicant; or
            ``(2) an application for the investigation of the drug 
        under section 505(i) (21 U.S.C. 355(i)) of such Act or section 
        351(a)(3).
    Nothing in this subsection shall be construed to prohibit a sponsor 
or applicant from declining such a designation.
    ``(b) Use of Animal Trials.--A drug for which approval is sought 
under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(d)) or section 351 on the basis of evidence of effectiveness 
that is derived from animal studies may be designated as a fast-track 
product for purposes of this section.
    ``(c) Priority Review.--
            ``(1) In general.--A countermeasure that is a drug or 
        biological product shall be subject to the performance goals 
        established by the Commissioner of Food and Drugs for priority 
        drugs or biological products.
            ``(2) Definition.--In this subsection, the term `priority 
        drugs or biological products' means a drug or biological 
        product that is the subject of a drug application referred to 
        in section 101(4) of the Food and Drug Administration 
        Modernization Act of 1997.''.

SEC. 1902. SYSTEMS BIOLOGY.

    (a) Findings.--Congress makes the following findings:
            (1) Systems biology, the application of computational tools 
        to understand the dynamic behavior of biological networks as 
        integrated systems rather than isolated parts, is an emerging 
        field of research.
            (2) Open-source systems biology can play a role in 
        accelerating understanding of complex biological systems, 
        increasing confidence in the analysis and prioritization of 
        drug targets, enabling predictive toxicology, and other 
        emerging capabilities.
            (3) Such capabilities can lead to shorter drug development 
        times, speeding the delivery of needed medication to address 
        public health concerns, and may help decrease or manage the 
        high risks associated with the entire drug development system, 
        resulting in a reduction of the mounting costs of drug 
        development and an increase in the number of new entities 
        brought to market to improve public health.
    (b) Implementation of Biology Research Programs.--The Secretary of 
Health and Human Services shall promulgate regulations implementing--
            (1) systems biology research programs, including systems 
        biology tool development, model development, and integration of 
        such research into experimental frameworks validating and 
        exploiting research results;
            (2) research efforts, including systems biology approaches, 
        directed to address the detection of biothreat agents through 
        blood samples; and
            (3) such programs described in the Food and Drug Report of 
        March 2004 entitled ``Critical Path Initiative'' that enable 
        the development of tools and methods for the rapid approval of 
        safe medications for the treatment of anticipated biohazards.

SEC. 1903. BIOTERROR AND INFECTIOUS DISEASE PROVISIONS.

    (a) Bioterror and Infectious Disease Provisions.--Chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended 
by adding at the end the following:

       ``Subchapter F--Bioterror and Infectious Disease Products

``SEC. 571. DEFINITIONS.

    ``In this subchapter:
            ``(1) Biological agent.--The term `biological agent', 
        `biological toxin', or any variation of any such term, means 
        any microorganism, virus, infectious substance, or biological 
        product, that may be used in a manner that is intended to cause 
        widespread death or serious bodily injury, including biological 
        agents and toxins described in paragraphs (1) and (2) of 
        section 178 of title 18, United States Code.
            ``(2) Bioterror or infectious disease product.--The term 
        `bioterror or infectious disease product' means a 
        countermeasure against a biological agent.
            ``(3) Countermeasure.--The term `countermeasure' means--
                    ``(A) a vaccine and related delivery system, anti-
                infective, microbicide, diagnostic technology, drug, 
                biological product, or other technology that can be 
                used to diagnose, treat, or prevent infection with or 
                bodily harm from, or the spread of, a biological or 
                chemical agent or toxin on the list described in 
                section 319F-3(f) of the Public Health Service Act, and 
                that is subject to applicable provisions of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
                the Public Health Service Act (42 U.S.C. 201 et seq.), 
                or the Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.);
                    ``(B) a therapy, diagnostic, or piece of equipment 
                that may be used to detect, treat, or prevent bodily 
                harm that may be caused by the use of nuclear or 
                radiological material as a terror weapon;
                    ``(C) a qualified countermeasure, as defined in 
                section 319F-1 of the Public Health Service Act (42 
                U.S.C. 247d-6a); and
                    ``(D) a security countermeasure, as defined in 
                section 319F-2 (42 U.S.C. 246d-6b).
            ``(4) Infectious disease.--
                    ``(A) In general.--The term `infectious disease' 
                means a disease in humans caused by--
                            ``(i) a microbe (including a bacteria, 
                        virus, fungus, or parasite) that is acquired by 
                        a person that reproduces in that person;
                            ``(ii) microbial products (such as 
                        botulinum toxin); or
                            ``(iii) a prion.
                    ``(B) Inclusion.--
                            ``(i) a disease in humans caused by a 
                        microorganism, whether or not--
                                    ``(I) such microorganism is 
                                acquired by an individual through 
                                human-to-human contact; or
                                    ``(II) if the individual is 
                                initially symptomatic of the disease; 
                                and
                            ``(ii) zoonotic diseases that may find 
                        hosts in animal and human populations.

``SEC. 572. DEPUTY COMMISSIONER FOR BIOLOGICAL, CHEMICAL, NUCLEAR, 
              RADIOLOGICAL, AND INFECTIOUS DISEASE PRODUCTS.

    ``(a) Establishment of Office.--There is established within the 
Office of Counterterrorism of the Office of the Commissioner of the 
Food and Drug Administration an Office of the Deputy Commissioner for 
Biological, Chemical, Nuclear, Radiological, and Infectious Disease 
Products (referred to in this section as the `Deputy Commissioner').
    ``(b) Duties.--The Deputy Commissioner shall--
            ``(1) oversee, plan, and direct resources and personnel of 
        the Center for Biologics Evaluation and Research, the Center 
        for Drug Evaluation and Research, and other relevant offices 
        within the Food and Drug Administration, toward the evaluation 
        of products for the prevention, surveillance, diagnosis, and 
        treatment of biological, chemical, nuclear, radiological, and 
        emerging infectious disease threats;
            ``(2) review not less than annually, the progress of such 
        offices with respect to the functions described under paragraph 
        (1); and
            ``(3) consult with the Commissioner of Food and Drugs with 
        respect to carrying out the duties described under paragraph 
        (1).
            ``(c) Authority.--The Deputy Commissioner shall have the 
        authority to address staffing needs and compensation for 
        shortfalls resulting from any waiver of user fees under section 
        574.

``SEC. 573. ACCELERATED APPROVAL FOR CERTAIN PRODUCTS.

    ``The Secretary shall, at the request of the sponsor of a new 
bioterror or infectious disease product, deem such countermeasure a 
fast track product under section 506 if--
            ``(1) there is no other countermeasure product approved by 
        the Food and Drug Administration sufficient to respond to the 
        bioterror or pathogen threat addressed by such new product; and
            ``(2) the bioterror or pathogen threat addressed by such 
        new product is eminent, as determined by the Secretary, in 
        consultation with the Secretary of Homeland Security and the 
        Director of the Centers for Disease Control and Prevention.

``SEC. 574. WAIVER OF USER FEES.

    ``(a) In General.--The Secretary shall waive the assessment of a 
user fee under chapter VII to the application and approval of a 
bioterror or infectious disease product. Such waivers shall not result 
in a reduction of funds available to the Secretary for conducting 
review of such applications and approvals.
    ``(b) Limitation.--The Secretary shall not waive an assessment of a 
user fee under subsection (a) for an applicant more than once.''.

SEC. 1904. APPROVALS OF CERTAIN DRUGS BASED ON ANIMAL TRIALS.

    (a) Federal Food, Drug, and Cosmetic Act.--Section 505(d) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) is amended by 
adding at the end the following: ``In the case of drugs and diagnostic 
devices for use against infectious disease or lethal or permanently 
disabling toxic biological, chemical, radiological, nuclear, or other 
substances, when adequate and well-controlled studies of effectiveness 
in humans cannot ethically be conducted because the studies would 
involve administering a potentially lethal or permanently disabling 
toxic substance or organism to healthy human volunteers, and when 
adequate field trials assessing use of the drug or diagnostic device 
(in situations such as after accidental or hostile exposure to the 
substance) have not been feasible or where adequate volumes of human 
samples for diagnosis from previous exposures is not available, the 
Secretary may grant approval based on evidence of effectiveness derived 
from appropriate studies in animals. The Secretary may promulgate 
regulations establishing standards, criteria, and procedures for use of 
the authority contained in the preceding sentence.''.
    (b) Public Health Service Act.--Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended by adding at the end the 
following:
    ``(k) Approval of Certain Products and Diagnostic Devices Based on 
Animal Trials.--In the case of biological products and diagnostic 
devices for use against infectious disease, or lethal or permanently 
disabling toxic biological, chemical, radiological, nuclear, or other 
substances, when definitive human effectiveness studies in humans 
cannot ethically be conducted because the studies would involve 
administering a potentially lethal or permanently disabling toxic 
substance or organism to healthy human volunteers, and when adequate 
field trials assessing use of the drug (in situations such as after 
accidental or hostile exposure to the substance) have not been 
feasible, the Secretary may grant approval based on evidence of 
effectiveness derived from appropriate studies in animals. The 
Secretary may promulgate regulations establishing standards, criteria, 
and procedures for use of the authority provided under this 
subsection.''.
    (c) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this section 
(and the amendments made by this section).

SEC. 1905. CLINICAL TRIAL GUIDELINES FOR ANTI-INFECTIVES.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 510 the following:

``SEC. 511. CLINICAL TRIAL GUIDELINES FOR ANTI-INFECTIVES.

    ``(a) In General.--Not later than 1 year after the date of 
enactment of the Project BioShield II Act of 2005, the Secretary, 
acting through the Commissioner of Food and Drugs, shall issue 
guidelines for the conduct of clinical trials with respect to anti-
microbials, including anti-microbials to treat resistant pathogens, 
bacterial meningitis, acute bacterial sinusitis, acute bacterial otitis 
media, and acute exacerbation of chronic bronchitis. Such guidelines 
shall indicate the appropriate animal models of infection, in vitro 
techniques, and valid microbiologic surrogate markers.
    ``(b) Review.--Not later than 5 years after the date of enactment 
of the Project BioShield II Act of 2005, the Secretary, acting through 
the Commissioner of Food and Drugs, shall review and update the 
guidelines described under subsection (a) to reflect developments in 
scientific and medical information and technology.''.

SEC. 1906. AUTHORIZATION OF APPROPRIATIONS FOR FDA PURCHASE OF 
              MICROBIOLOGICAL DATA.

    (a) In General.--There are authorized to be appropriated $3,000,000 
for fiscal year 2007 for the purpose of strengthening the ability of 
the Food and Drug Administration to evaluate antibiotics for the 
treatment of targeted pathogens.
    (b) Sole purpose.--Such funds shall be used solely for the purpose 
of contracting with entities that the Secretary of Health and Human 
Services determines capable of providing national, real-time 
microbiological data relevant to antibiotic sensitivity of all 
clinically relevant strains of bacterial pathogens.

SEC. 1907. AUTHORIZATION OF APPROPRIATIONS TO IMPLEMENT PUBLIC HEALTH 
              SERVICE ACTION PLAN TO COMBAT ANTIMICROBIAL RESISTANCE.

    To implement the Public Health Service action plan to combat 
antimicrobial resistance (Public Health Action Plan to Combat 
Antimicrobial Resistance, Part 1: Domestic Issues (January 18, 2001)) 
as developed by the Interagency Antimicrobial Resistance Task Force 
authorized under section 319E of the Public Health Service Act (42 
U.S.C. 247d-5), there are authorized to be appropriated $25,000,000 for 
fiscal year 2007.

                        TITLE XX--ANIMAL MODELS

SEC. 2001. ANIMAL MODELS FOR CERTAIN DISEASES.

    (a) Finding.--Congress finds that the development of well-
characterized animal models for identified threat agents is crucial for 
testing the efficacy of medical countermeasures, and that data is 
crucial for licensure of products to protect the Nation, particularly 
those animals genetically designed and bred to mimic the disease or 
toxic response of humans to a particular biological insult.
    (b) Establishment of Working Group; Grants To Study Animal 
Responses.--Subpart 6 of part C of title IV of the Public Health 
Service Act (42 U.S.C. 285f et seq.) is amended by adding at the end 
the following:

``SEC. 447C. ESTABLISHMENT OF WORKING GROUP.

    ``(a) In General.--The Director of the Institute, in consultation 
with the Assistant Secretary for Medical Readiness and Response of the 
Department of Homeland Security and the Director of the Centers for 
Disease Control and Prevention, shall establish a working group to 
carry out the duties described in subsection (b) (referred to in this 
section as the `Working Group').
    ``(b) Duties.--The Working Group shall determine the most pressing 
scientific gaps in understanding that must be addressed to create 
accurate animal models used to determine disease processes for agents 
that threaten humans.
    ``(c) Membership.--The Working Group shall include not less than 
one Director of a center in the National Private Research Program.

``SEC. 447D. GRANTS TO STUDY ANIMAL RESPONSES.

    ``(a) In General.--The Secretary, in consultation with the 
Commissioner of Food and Drugs and the Secretary of Homeland Security, 
shall--
            ``(1) establish and award grants under this section to 
        eligible entities to study the physiological responses of 
        certain animal species to bioterrorism agents and other 
        infectious agents; and
            ``(2) coordinate efforts to identify and develop well-
        characterized animal models, including correlates of 
        protection, when feasible, for categories of infectious 
        diseases, and classes of toxins considered the most likely 
        threats to human populations, as identified as bioterror agents 
        by the Office of Emergency Preparedness and Response of the 
        Centers for Disease Control and Prevention.
    ``(b) Eligibility; Application.--To be eligible to receive a grant 
under this section, an entity shall--
            ``(1) provide assurances to the Secretary that the entity 
        has a biosafety level 3 or 4 facility that is approved by the 
        Centers for Disease Control and Prevention or has a contractual 
        relationship with such a facility; and
            ``(2) with respect to an animal biosafety lab, provide 
        assurances that such lab is in compliance with the Guide for 
        the Care and Use of Laboratory Animals and the Animal Welfare 
        Act (7 U.S.C. 2131 note); and
            ``(3) submit to the Secretary an application at such time, 
        in such manner, and containing such information as the 
        Secretary may require.
    ``(c) Benefits Under Project BioShield.--
            ``(1) In general.--If the Secretary determines that an 
        entity receiving a grant under this section has successfully 
        and thoroughly created an animal model for the purpose of 
        testing and regulating novel countermeasures, such animal model 
        shall be considered a research tool for purposes of receiving 
        the benefits under the amendments made by the Project BioShield 
        II Act of 2005.
            ``(2) Clarification.--An animal model may be developed, and 
        subsequently recommended by the Food and Drug Administration, 
        separately from a countermeasure application so that such 
        animal model is regarded as a research tool for the 
        countermeasure and such Administration may require such 
        recommended animal model in clinical trials to fulfill 
        regulatory requirements.
    ``(d) Definitions.--
            ``(1) Biosafety level 3 facility.--The term `biosafety 
        level 3 facility' means a facility described in section 627.15 
        of title 32, Code of Federal Regulations (or any successor 
        regulation).
            ``(2) Biosafety level 4 facility.--The term `biosafety 
        level 4 facility' means a facility described in section 627.16 
        of title 32, Code of Federal Regulations (or any successor 
        regulation).
            ``(3) Research tool.--The term `research tool' includes the 
        full range of tools that scientists may use in the laboratory, 
        including animal disease models, cell lines, cell line cultures 
        for the production of biologics, monoclonal and polyclonal 
        antibodies, reagents, drug delivery technologies, vaccine 
        adjuvants, laboratory animals, large animals including nonhuman 
        primates and large animals used for drug production, growth 
        factors, combinatorial chemistry and DNA libraries, antigen 
        libraries, clones and cloning tools (such as PCR or Real Time 
        PCR), methods, laboratory equipment and machines, databases, 
        and other technologies that enable the rapid and effective 
        development of countermeasures, including diagnostics, 
        vaccines, and drugs.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary for the development of 
animals models described under subsection (a)(2).''.

SEC. 2002. ANIMAL MODELS FIVE-YEAR INITIATIVE.

    (a) Findings.--Congress finds the following:
            (1) The United States Government has made an unprecedented 
        commitment to expanding and advancing the biomedical research 
        program at the National Institutes of Health, and the success 
        of the Government's efforts is contingent upon the availability 
        of quality resources that will enable and enhance all research 
        endeavors ranging from the most basic and fundamental to the 
        most highly innovative.
            (2) Biomedical research has relied on such quality 
        resource, the National Primate Research Centers Program, for 
        more than 40 years, for research models and expertise with non-
        human primates.
            (3) The National Primate Research Centers Program is 
        comprised of a network of 8 National Primate Research Centers 
        (referred to in this section ``NPRCs'') that provide 
        centralized housing and care for non-human primates, as well as 
        the facilities and support necessary for research conducted 
        with such primates. Scientists from almost every State use the 
        resources of the NPRCs for a vast array of studies.
            (4) As a result of expanded investment in biomedical 
        research from 2000 to 2005, the demand for the resources of the 
        NPRCs has increased significantly, but several important 
        impediments have become barriers to successful non-human 
        primate research, including the limited number of such primates 
        available, the lack of infrastructure to breed and house 
        animals for research, and the need for trained staff for 
        handling and sophisticated care.
            (5) In order to remedy such problems, the National 
        Institutes of Health needs to support a Federal advancement 
        initiative for the NPRCs that addresses the necessary upgrades 
        and program capacity expansions.
    (b) Five-year Initiative for Primate Centers.--
    Subpart 1 of Part E of title IV of the Public Health Service Act 
(42 U.S.C. 287 et seq.) is amended by--
            (1) redesignating the section 481C as added by Public Law 
        106-505 as section 481D; and
            (2) by adding at the end the following:

``SEC. 481E. FIVE-YEAR INITIATIVE FOR PRIMATE CENTERS.

    ``(a) In General.--The Secretary shall provide additional sums to 
the base grants provided to the National Primate Research Centers by 
the National Center for Research Resources in order to--
            ``(1) increase domestic breeding capabilities;
            ``(2) develop bridging programs to effectively utilize 
        additional primate species;
            ``(3) increase the quality and capacity of primate housing 
        and breeding facilities and the availability of related state-
        of-the-art diagnostic and clinical support equipment for 
        primates; and
            ``(4) increase the number of personnel trained in primate 
        care and management at the National Primate Research Centers.
    ``(b) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this 
section.''.

            TITLE XXI--STRENGTHENING OF THE VACCINE INDUSTRY

     Subtitle A--Biologics, Adjuvants, and Cell Culture Development

SEC. 2101. BIOLOGICS MANUFACTURING CAPACITY INCENTIVES.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) (as amended by sections 202 and 1901) is amended by inserting 
after section 319F-4 (as added by section 1901) the following:

``SEC. 319F-5. BIOLOGICS MANUFACTURING CAPACITY INCENTIVES.

    ``(a) Survey and Plan.--Not later than 90 days after the date of 
enactment of the Project BioShield II Act of 2005, the Secretary 
shall--
            ``(1) conduct a survey of the biologics manufacturing and 
        filling facilities, including those for the production of 
        antibiotics, vaccines, monoclonal and polyclonal antibodies, 
        recombinant proteins, and plant compounds using cell culture 
        methods, recombinant technology or other techniques, as well as 
        those for the production of antibodies and other blood products 
        from human and animal blood, operating in the United States and 
        determine whether additional manufacturing facilities that will 
        be needed (and if so the number of such facilities) to 
        manufacture and stockpile biologically active materials for 
        bioterrorist attacks or infectious disease outbreaks; and
            ``(2) develop a plan to ensure that sufficient biologics 
        manufacturing and filling facilities are available in the 
        United States, Canada, Mexico, Europe, and Japan, when they are 
        needed, including an analysis of the feasibility of the Federal 
        Government contracting for the construction and maintenance of 
        such facilities or of providing tax and other incentives for 
        the construction and maintenance of such facilities by private 
        sector entities.
    ``(b) Submission to Congress.--The Secretary shall submit the plan 
developed under subsection (a)(2) to Congress together with 
recommendations concerning the manner in which to ensure that the 
needed biologics manufacturing facilities available for the production 
of countermeasures under this title are constructed and available, 
including the siting, design and certification costs, costs of training 
and recruitment of expert staff, and other costs associated with such 
facilities.
    ``(c) Incentives for the Construction of Biologics Manufacturing 
Facilities Available for the Production of Countermeasures.--The 
Secretary shall issue regulations regarding the selection of an entity 
that agrees to operate as a biologics manufacturing facility available 
for the production of countermeasures under this title in accordance 
with the plan developed under subsection (a)(2) for the investment tax 
credit provided under the amendments made by title III of the Project 
BioShield II Act of 2005. Such regulations shall state when such an 
entity shall be available and the terms for the use for the production 
of such countermeasures. If an entity is constructed to produce such 
countermeasures, such entity shall provide notice that such entity is 
available to produce such countermeasures.''.

SEC. 2102. BIOLOGICS MANUFACTURING EFFICIENCY INCENTIVES.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) (as amended by sections 202, 1901, and 2101) is amended by 
inserting after section 319F-5 (as added by section 2101) the 
following:

``SEC. 319F-6. BIOLOGICS MANUFACTURING EFFICIENCY INCENTIVES.

    ``(a) Findings.--Congress finds that--
            ``(1) the manufacturing of biologics, which are derived 
        from living organisms, is an art as well as a science;
            ``(2) the efficiency of the biologics manufacturing process 
        determines the output capacity, purity, and manufacturing cost 
        of antibiotics, vaccines, recombinant proteins, plant 
        compounds, antibodies, and blood products;
            ``(3) technical advances in manufacturing sciences for 
        biologics can increase the capacity of the Federal Government 
        to ensure that antibiotics, vaccines, recombinant proteins, 
        plant compounds, antibodies, and blood products are available 
        as part of a bioterror or infectious disease plan and to reduce 
        the cost of manufacturing and stockpiling these vaccines, 
        recombinant proteins, plant compounds, antibodies, and blood 
        products; and
            ``(4) the subjects of research relating to the 
        manufacturing of biologics may include the development of--
                    ``(A) additional well-characterized cell lines or 
                host strains for antibiotics, vaccines, recombinant 
                proteins, plant compounds, and monoclonal and 
                polyclonal antibody production;
                    ``(B) new biologic and chemical standards for use 
                in product testing, including testing of potency and 
                purity;
                    ``(C) improved preservatives for vaccines or other 
                biologics to prolong shelf-life;
                    ``(D) adjuvants that enhance the immune response;
                    ``(E) tests to determine contamination with human 
                or animal viruses or prions;
                    ``(F) improved tests of potency and purity during 
                the manufacturing process, not just for the final 
                product;
                    ``(G) improved characterization of biologics at the 
                macro-molecular level;
                    ``(H) processes that enhance the yield and quality 
                of biologics;
                    ``(I) improved methods that enhance disinfection 
                and sterilization of material and facilities;
                    ``(J) new methods to improve output, manufacturing 
                costs, and product quality with a particular emphasis 
                on downstream processing (separation and purification) 
                where particular bottlenecks occur with much lost 
                product, complexity, and very high costs; and
                    ``(K) improved methods for decontamination of 
                production facilities to enable switching from one 
                product to another.
    ``(b) Survey and Plan.--Not later than 180 days after the date of 
enactment of the Project BioShield II Act of 2005, the Secretary 
shall--
            ``(1) conduct a survey of existing biologics manufacturing 
        sciences and determine whether technical advances in such 
        sciences might increase the biologics output capacity and 
        purity, and lower the manufacturing cost of antibiotics, 
        vaccines, recombinant proteins, plant compounds, antibodies, 
        and blood products; and
            ``(2) develop a plan to provide incentives to enhance 
        scientific research to develop new technologies identified 
        under the survey conducted under paragraph (1), including a 
        list of the possible technologies that may be developed and the 
        possible incentives that may lead to their development.
    ``(c) Submission to Congress.--The Secretary shall submit the plan 
developed under subsection (b)(2) to Congress together with 
recommendations concerning the provision of funding or incentives for 
the conduct of scientific research to develop new technologies relating 
to biologics manufacturing sciences.
    ``(d) Incentives.--The Secretary shall establish a program under 
which entities that agree to develop new technologies, or improve 
existing technologies, in accordance with the plan developed under 
subsection (b)(2) are eligible for the tax incentives provided for 
under the amendments made by section 312 of the Project BioShield II 
Act of 2005.''.

SEC. 2103. DEVELOPMENT OF VACCINE ADJUVANTS.

    (a) Findings.--Congress finds the following:
            (1) New vaccines are under development and testing for the 
        control of infectious diseases including human immunodeficiency 
        virus infection, anthrax, avian flu, and many others, and 
        additional infectious diseases can be anticipated with advanced 
        rapid, along with advanced rapid production of vaccine 
        technologies.
            (2) Most new vaccines are composed of synthetic, 
        recombinant, or highly purified subunit antigens that are safer 
        than those in use as of the date of enactment of this Act, but 
        their purity can result in a weaker protective response from 
        the vaccine recipient.
            (3) Vaccines are administered to protect a healthy 
        population, and any complications with vaccines result in swift 
        and severe public and legal responses.
            (4) Adjuvants are chemicals that enhance the specific 
        protective immune response of vaccines.
            (5) As of 2005, there is one aluminum salt-based adjuvant 
        used in vaccines licensed in the United States.
            (6) Standardized methods to evaluate new vaccine adjuvant 
        safety must be implemented for human vaccines that are to be 
        formulated with novel adjuvants.
            (7) Vaccine adjuvants should receive highest priority by 
        the Food and Drug Administration and the National Institute of 
        Allergy and Infectious Diseases, as the failure to develop and 
        approve them will result in the inability to deploy effective 
        countermeasures against bioterrorism or naturally occurring 
        infectious diseases, even when vaccine development is achieved.
    (b) Vaccine Adjuvant Priority.--The Secretary of Health and Human 
Services shall promulgate regulations that establish--
            (1) priority handling procedures, which may included 
        expedited review and fee waivers, at the Food and Drug 
        Administration with respect to vaccine adjuvants; and
            (2) methods for evaluating the safety of--
                    (A) adjuvants, separate from the methods used to 
                evaluate the safety and effectiveness of adjuvants with 
                vaccine agents; and
                    (B) adjuvants used in conjunction with one or more 
                vaccine agent.
    (c) Incentives for Vaccine Adjuvant Producers.--
            (1) In general.--Persons that produce adjuvants shall be 
        entitled to receive the incentives under title III (and the 
        amendments made by that title).
            (2) Defense of certain malpractice and negligence suits.--
        Section 224 of the Public Health Service Act (42 U.S.C. 233) 
        (as amended by title III of this Act) shall apply to vaccine 
        adjuvants developed for use in bioterrorism countermeasures or 
        to treat or prevent infectious disease in the same manner as 
        such section applies to covered countermeasures (as defined by 
        such section).
    (d) Requests for Proposals.--The Secretary of Health and Human 
Services shall develop and publish in the Federal Register a request 
for proposals with respect to adjuvant development and production.
    (e) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary carry out this section.

SEC. 2104. CELL CULTURE OR RECOMBINANT VACCINES.

    (a) Grants.--The Director of the National Institutes of Health, in 
consultation with the Commissioner of Food and Drugs and the Director 
of the Centers of Disease Control and Prevention, may award grants to 
eligible entities for the development of cell-culture and other vaccine 
production technologies.
    (b) Eligibility.--To be eligible to receive a grant under this 
section an entity shall--
            (1) be a public or private entity determined appropriate by 
        the Director of the National Institutes of Health; and
            (2) prepare and submit to the Director an application at 
        such time, in such manner, and containing such information as 
        the Director may require.
    (c) Use of Funds.--An entity shall use amounts received under a 
grant under this section to carry out activities leading to the 
development of cell-culture and other vaccine production technology, 
including the retooling of outdated plants and the construction of new 
manufacturing plants.
    (d) Activities of the Food and Drug Administration.--To further the 
goal of increasing the production of cell culture and other vaccines, 
the Food and Drug Administration shall--
            (1) develop updated regulations relating to the approval of 
        cell culture and other vaccines; and
            (2) as part of such regulations, provide for priority to be 
        given to the inspection and evaluation of cell culture and 
        other vaccine manufacturing plants.
    (e) Activities of the Secretary.--To further the goal of increasing 
the production of cell culture and other vaccines, the Secretary of 
Health and Human Services shall--
            (1) develop a strategic plan for the distribution of 
        biologicals developed at facilities constructed under a grant 
        under this section in the case of an infectious disease 
        outbreak; and
            (2) not later than 6 months after the date of enactment of 
        this Act, submit to the appropriate committees of Congress a 
        report on the strategy developed under paragraph (1) and on the 
        status and use of previous vaccine development grants.
    (f) Authorization of Appropriations.--There is authorized to be 
appropriated such sums as may be necessary to carry out this section.

                     Subtitle B--Influenza Vaccine

            CHAPTER 1--INFLUENZA VACCINE AWARENESS CAMPAIGN

SEC. 2111. AWARENESS CAMPAIGN AND EDUCATION AND OUTREACH EFFORTS.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding at the end the following:

``SEC. 399O. AWARENESS CAMPAIGN AND EDUCATION AND OUTREACH EFFORTS.

    ``(a) Campaign.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention (in this section referred to 
as the `Director'), shall conduct a public awareness campaign and 
education and outreach efforts each year during the time period 
preceding the influenza season on each of the following:
            ``(1) The importance of receiving the influenza vaccine.
            ``(2) Which populations the Director recommends to receive 
        the influenza vaccine to prevent health complications 
        associated with influenza, including health care workers and 
        household contacts.
            ``(3) Professional medical education of physicians, nurses, 
        pharmacists, and other health care providers and such 
        providers' associated organizations.
            ``(4) Information that emphasizes the safety and benefit of 
        recommended vaccines for the public good.
    ``(b) Outreach to Medicare Recipients.--
            ``(1) In general.--The Administrator of the Centers for 
        Medicare & Medicaid Services shall, at the earliest possible 
        time in the influenza vaccine planning and production process, 
        reach out to providers of medicare services, including managed 
        care providers, nursing homes, hospitals, and physician offices 
        to urge early and full preordering of the influenza vaccine so 
        that production levels can accommodate the needs for the 
        influenza vaccine.
            ``(2) Rates of immunization among medicare recipients.--The 
        Director shall work with the Administrator of the Centers for 
        Medicare & Medicaid Services to publish the rates of influenza 
        immunization among individuals receiving assistance under the 
        medicare program under title XVIII of the Social Security Act 
        (42 U.S.C. 1395 et seq.).
    ``(c) State and Public Health Adult Immunization Activities.--The 
Director shall support the development of State adult immunization 
programs that place emphasis on improving influenza vaccine delivery to 
high-risk populations and the general population, including the 
exploration of improving access to the influenza vaccine.
    ``(d) Efficacy of Vaccine.--The Director shall work with 
appropriate agencies in conducting a study to assess the efficacy of 
the influenza vaccine.
    ``(e) Existing Modes of Communication.--In carrying out the public 
awareness campaign and education and outreach efforts under subsections 
(a) and (b), the Director may use existing websites or structures for 
communication.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $10,000,000 for each of fiscal 
years 2005 through 2009.''.

           CHAPTER 2--ENCOURAGING VACCINE PRODUCTION CAPACITY

SEC. 2121. INCENTIVES FOR THE CONSTRUCTION OF VACCINE MANUFACTURING 
              FACILITIES.

    (a) Vaccine Manufacturing Facilities Investment Tax Credit.--
            (1) Allowance of credit.--Section 46 of the Internal 
        Revenue Code of 1986 (relating to amount of investment credit) 
        is amended by striking ``and'' at the end of paragraph (1), by 
        striking the period at the end of paragraph (2) and inserting 
        ``, and'', and by adding at the end the following new 
        paragraph:
            ``(3) the vaccine manufacturing facilities investment 
        credit.''.
            (2) Amount of credit.--Subpart E of part IV of subchapter A 
        of chapter 1 of such Code (relating to rules for computing 
        investment credit) is amended by inserting after section 48 the 
        following new section:

``SEC. 48A. VACCINE MANUFACTURING FACILITIES CREDIT.

    ``(a) In General.--For purposes of section 46, the influenza 
vaccine manufacturing facilities investment credit for any taxable year 
is an amount equal to 20 percent of the qualified investment for such 
taxable year.
    ``(b) Qualified Investment.--
            ``(1) In general.--For purposes of subsection (a), the 
        qualified investment for any taxable year is the basis of each 
        influenza vaccine manufacturing facilities property placed in 
        service by the taxpayer during such taxable year.
            ``(2) Vaccine manufacturing facilities property.--For 
        purposes of this section, the term `influenza vaccine 
        manufacturing facilities property' means real and tangible 
        personal property--
                    ``(A)(i) the original use of which commences with 
                the taxpayer, or
                    ``(ii) which is acquired through purchase (as 
                defined by section 179(d)(2)),
                    ``(B) which is depreciable under section 167,
                    ``(C) which is used for the manufacture, 
                distribution, or research and development of vaccines, 
                and
                    ``(D) which is in compliance with any standards and 
                regulations which are promulgated by the Food and Drug 
                Administration, the Occupational Safety and Health 
                Administration, or the Environmental Protection Agency 
                and which are applicable to such property.
    ``(c) Certain Progress Expenditure Rules Made Applicable.--Rules 
similar to rules of subsections (c)(4) and (d) of section 46 (as in 
effect on the day before the date of the enactment of the Revenue 
Reconciliation Act of 1990) shall apply for purposes of this 
subsection.
    ``(d) Termination.--This subsection shall not apply to any property 
placed in service after December 31, 2009.''.
    (b) Technical Amendments.--
            (1) Clause (iii) of section 49(a)(1)(C) of such Code is 
        amended to read as follows:
                            ``(iii) the basis of any vaccine 
                        manufacturing facilities property.''.
            (2) Subparagraph (E) of section 50(a)(2) of such Code is 
        amended by inserting ``or 48A(c)'' before the period.
            (3) The table of sections for subpart E of part IV of 
        subchapter A of chapter 1 of such Code is amended by inserting 
        after the item relating to section 48 the following:

``Sec. 48A. Vaccine manufacturing facilities credit.''.
    (c) Effective Date.--The amendments made by this section shall 
apply to property placed in service after December 31, 2004, under 
rules similar to the rules of section 48(m) of the Internal Revenue 
Code of 1986 (as in effect on the day before the date of enactment of 
the Revenue Reconciliation Act of 1990).

           CHAPTER 3--ENSURING SUFFICIENT FLU VACCINE SUPPLY

SEC. 2131. VACCINE SUPPLY.

    Title XXI of the Public Health Service Act (42 U.S.C. 300aa-1 et 
seq.) is amended by adding at the end the following:

                    ``Subtitle 3--Influenza Vaccine

                            ``vaccine supply

    ``Sec. 2141. (a) Requests for More Doses.--
            ``(1) In general.--Not later than March 15 of each year, 
        the Secretary shall enter into contracts with manufacturers to 
        produce such additional doses of the influenza vaccine as 
        determined necessary by the Secretary.
            ``(2) Content of contract.--A contract for additional doses 
        shall provide that the manufacturer will be compensated by the 
        Secretary at an equitable rate negotiated by the Secretary and 
        the manufacturer for any doses that--
                    ``(A) were not sold by the manufacturer through 
                routine market mechanisms at the end of the influenza 
                season for that year; and
                    ``(B) were requested by the Secretary to be 
                produced by such manufacturer.
            ``(3) When such vaccine purchases should take place.--The 
        Secretary may purchase from the manufacturer the doses for 
        which it has contracted at any time after which it is 
        determined by the Secretary, in consultation with the 
        manufacturer, that the doses will likely not be absorbed by the 
        private market.
    ``(b) Contingency Plan.--The Secretary shall encourage States to 
develop a contingency plan, in coordination with the Department of 
Health and Human Services, for maximizing influenza immunization for 
high-risk populations in the event of a delay or shortage of the 
influenza vaccine.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be 
necessary.''.

            CHAPTER 4--PREPARING FOR A PANDEMIC OR EPIDEMIC

SEC. 2141. PREPARATION FOR INFLUENZA PANDEMIC OR EPIDEMIC; ANTI-VIRALS 
              SUPPLY.

    Subtitle 3 of title XXI of the Public Health Service Act, as added 
by section 2131, is amended by adding at the end the following:

            ``preparation for influenza pandemic or epidemic

    ``Sec. 2142. (a) Establishment of a Protocol.--The Secretary, 
acting through the Director of the National Vaccine Program (referred 
to in this section as the `Director of the Program'), shall continue 
progress on the pandemic preparedness plan and, in consultation with 
the Director of the Centers for Disease Control and Prevention, 
establish a protocol to attempt to prevent, prepare for, and respond to 
an influenza pandemic or epidemic. Such protocol shall be updated as 
determined appropriate by the Director of the Program.
    ``(b) Contents of Protocol.--The protocol established under 
subsection (a) shall--
            ``(1) improve upon the current influenza vaccines and 
        production and dissemination methods; and
            ``(2) address--
                    ``(A) methods to coordinate dissemination of the 
                influenza vaccine to key populations in the event of an 
                influenza pandemic or epidemic;
                    ``(B) expansion of influenza vaccine manufacturing 
                capacity (including making advance arrangements for 
                ensuring the availability of raw materials) to respond 
                to the needs of the United States during an influenza 
                pandemic or epidemic;
                    ``(C) alternative ways to manufacture or produce 
                the influenza vaccine;
                    ``(D) alternative methods to prevent the spread of, 
                and complications associated with, influenza, including 
                anti-viral medications;
                    ``(E) vaccine manufacturing capacity, production, 
                and dissemination to improve preparedness for immediate 
                pandemic threats, which may include avian influenza;
                    ``(F) a tracking method for publicly and privately 
                sold doses of the influenza vaccine to enable the 
                Director of the Program to determine, after 
                consultation with manufacturers of the influenza 
                vaccine, how much supply is in circulation in the case 
                of an influenza pandemic or epidemic; and
                    ``(G) other issues determined by the Director of 
                the Program to be appropriate.
    ``(c) Coordination; Preparation; Prevention.--In establishing the 
protocol under subsection (a), the Director of the Program shall--
            ``(1) coordinate with health care providers, manufacturers, 
        research institutions, health care organizations, and other 
        expert stakeholders;
            ``(2) continue building international and national 
        surveillance capacity;
            ``(3) continue to engage in epidemiological studies and 
        research on novel influenza viruses; and
            ``(4) assist States with preparedness activities for a 
        rapid State and local response to an influenza pandemic, 
        including exploring methods of making the influenza vaccine 
        more accessible to the general population.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $150,000,000 for each of fiscal 
years 2005 through 2009.

``SEC. 2143. INFLUENZA ANTI-VIRALS SUPPLY.

    ``(a) In General.--The Secretary shall establish a stockpile of 
anti-virals to use for rapid response to an influenza outbreak.
    ``(b) Amount.--The stockpile established under subsection (a) shall 
be of sufficient quantity to treat not less than 2 percent of the 
population of the United States.''.

                  CHAPTER 5--REPORT AND ADMINISTRATION

SEC. 2151. REPORT TO CONGRESS.

    Not later than 180 days after the date of enactment of this Act, 
the Director of the Centers for Disease Control and Prevention, in 
consultation with the Assistant Secretary for Medical Readiness and 
Response of the Department of Homeland Security and the Director of the 
National Institute for Allergy and Infectious Disease of the National 
Institutes of Health, shall submit a report to Congress that describes 
alternatives to traditional vaccines and anti-viral therapeutics for 
viral diseases, including negative immunomodulation compounds that 
partially suppress a macrophage-dependent innate immune response of an 
individual to viral pathogens, in order to decrease morbidity and 
mortality from an excessive immune response.

SEC. 2152. SIMPLIFIED ADMINISTRATION OF VACCINE SUPPLY.

    Section 1928(d)(6) of the Social Security Act (42 U.S.C. 
1396s(d)(6)) is amended by inserting before the last sentence the 
following: ``The Secretary may sell such quantities of vaccines from 
such supply as the Secretary determines appropriate. Proceeds received 
from such sales shall be available to the Secretary solely for the 
purposes of this section and shall remain available until expended.

SEC. 2153. MEDICARE COVERAGE OF VACCINES AND PROPHYLAXIS AS 
              COUNTERMEASURES.

    (a) Findings.--Congress finds the following:
            (1) In the event of a bioterrorism attack or infectious 
        disease outbreak, it is in the public interest to ensure 
        appropriate and timely voluntary utilization of critical 
        vaccines and other prophylaxis against these pathogens.
            (2) Such voluntary utilization in such emergency will be 
        increased if the vaccines and other prophylaxis are covered 
        under Medicare Part B.
            (3) Such voluntary utilization reduces adverse impacts on 
        the public health infrastructure and assists in containing the 
        pathogen without the need to impose quarantines.
            (4) Coverage and reimbursement for most vaccines and other 
        prophylaxis currently is not available under Medicare Part B.
            (5) Medicare Part B does cover diagnostic services as well 
        as drugs and biological products that are administered incident 
        to a physician's services that are not usually self-
        administered by the patient as long as they are ``reasonable 
        and necessary for the diagnosis or treatment of illness or 
        injury or to improve the function of a malformed body member''.
            (6) The public interest would be served best by extending 
        Medicare Part B coverage and reimbursement to vaccines and 
        prophylaxis that would combat a wide variety of chemical and 
        biological agents, toxins, nuclear and radiological materials, 
        and emerging infectious diseases.
    (b) Amendment to the Social Security Act to Extend Coverage.--
Section 1861(s)(10)(A) of the Social Security Act (42 U.S.C. 
1396x(s)(10)(A)) is amended by inserting ``, a vaccine or prophylaxis 
against any of the agents, toxins, or materials on the list developed 
by the Secretary under section 319F-3(f) of the Public Health Service 
Act and its administration'' after ``pneumococcal vaccine and its 
administration''.
    (c) Effective Date.--The amendment made by subsection (b) shall 
apply to items furnished on or after the date of enactment of this Act.

      TITLE XXII--GAAP ACCOUNTING FOR VACCINE REVENUE RECOGNITION

SEC. 2201. GAAP ACCOUNTING FOR VACCINE PROCUREMENT.

    Not later than 180 days after the date of enactment of this Act, 
the Secretary of Health and Human Services and the Secretary of 
Homeland Security, in consultation with appropriate representatives 
from the Securities and Exchange Commission (as determined by such 
Secretaries) shall meet to determine--
            (1) how contracts entered into under the Project BioShield 
        Act of 2004 and the Project BioShield II Act of 2005 (and the 
        amendments made by such Acts) may be structured so that a 
        person that enters such a contract can recognized revenue under 
        General Acceptable Accounting Principles accounting rules; or
            (2) how the Securities and Exchange Commission may 
        interpret its Staff Accounting Bulletin Number 104 of December 
        17, 2003, to achieve the result described under paragraph (1).

  TITLE XXIII--HUMAN CLINICAL TRIALS AND DRUGS FOR RARE DISEASES AND 
                               CONDITIONS

SEC. 2301. EXPANDED HUMAN CLINICAL TRIALS QUALIFYING FOR ORPHAN DRUG 
              CREDIT.

    (a) Expanded Human Clinical Trials Qualifying for Orphan Drug 
Credit.--
            (1) In general.--Subclause (I) of section 45C(b)(2)(A)(ii) 
        of the Internal Revenue Code of 1986 is amended to read as 
        follows:
                                    ``(I) after the date that the 
                                application is filed for designation 
                                under such section 526, and''.
            (2) Conforming amendments.--Clause (i) of section 
        45C(b)(2)(A) of the Internal Revenue Code of 1986 is amended by 
        inserting ``which is'' before ``being'' and by inserting before 
        the comma at the end ``and which is designated under section 
        526 of such Act''.
            (3) Effective date.--The amendments made by this subsection 
        shall apply to amounts paid or incurred after December 31, 
        2003.
    (b) Publication of Filing and Approval of Requests for Designation 
of Drugs for Rare Diseases or Conditions.--Subsection (c) of section 
526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) is 
amended to read as follows:
    ``(c) Not less than monthly, the Secretary shall publish in the 
Federal Register, and otherwise make available to the public, notice of 
requests for designation of a drug under subsection (a) and approvals 
of such requests. Such notice shall include--
            ``(1) the name and address of the manufacturer and the 
        sponsor;
            ``(2) the date of the request for designation or of the 
        approval of such request;
            ``(3) the nonproprietary name of the drug and the name of 
        the drug under which an application is filed under section 
        505(b) of this Act or section 351 of the Public Health Service 
        Act;
            ``(4) the rare disease or condition for which the 
        designation is requested or approved; and
            ``(5) the proposed indication for use of the product.''.

  TITLE XXIV--HEALTHCARE SYSTEM COLLECTION OF CLINICAL DATA REGARDING 
              SAFETY AND EFFECTIVENESS OF COUNTERMEASURES

SEC. 2401. FINDINGS; DEFINITIONS.

    (a) Purpose.--The purpose of this title is to provide necessary 
protocols and funding to ensure that real time clinical data about a 
countermeasure, as it is utilized, may be extracted in order to assess 
the appropriate role of such countermeasure in responding to a terror 
attack or outbreak of infectious disease.
    (b) Definitions.--In this title:
            (1) Clinical countermeasures delivery.--The term ``clinical 
        countermeasures delivery'' refers to the coordinated 
        development, implementation, and evaluation of consistent 
        clinical countermeasures policies, diagnostic procedures and 
        protocols, education and training, and necessary medical 
        capacities (such as administrative support, infrastructure 
        including healthcare epidemiology, laboratories, information 
        systems, leadership and expert personnel, research capability, 
        equipment and supplies) for the healthcare delivery and 
        response community within a defined geographic area that takes 
        into account populations at risk and vulnerabilities to 
        pathogens and agents.
            (2) Clinical countermeasures delivery center.--The term 
        ``clinical countermeasures delivery center'' means a nonprofit 
        health or public health, medical center, or public hospital, 
        including an academic health center or other similar 
        organization, that dedicates a significant percentage of its 
        resources for the coordination of healthcare delivery, 
        research, education, and integrated community services, as 
        determined by the Assistant Secretary for Medical Readiness and 
        Response of the Department of Homeland Security.
            (3) Emergency situation.--The term ``emergency situation'' 
        means a natural or man-made event that requires an emergency 
        response and is designated as an emergency by the President, a 
        Governor through an appropriate State emergency management 
        coordinator, local government executive, or a county emergency 
        manager (only with respect to a condition for a period not to 
        exceed 24 hours pending review and approval by a Governor) in 
        which clinical countermeasures may or will be utilized.
            (4) Healthcare delivery and response community.--The term 
        ``healthcare delivery and response community'' means 
        individuals, entities, and institutions that provide--
                    (A) direct patient healthcare, public health, or 
                community health; or
                    (B) emergency medical care, such as emergency 
                medical, fire, and police services.
            (5) Qualified clinical countermeasures delivery center.--
        The term ``qualified clinical countermeasures delivery center'' 
        means a clinical countermeasures delivery center that has been 
        certified under section 2402 as in compliance with the 
        requirements of section 2403.
            (6) Assistant secretary.--The term ``Assistant Secretary'' 
        means the Assistant Secretary for Medical Readiness and 
        Response of the Department of Homeland Security.

SEC. 2402. CERTIFICATION OF CLINICAL COUNTERMEASURES DELIVERY CENTERS.

    (a) Establishment of Program.--The Assistant Secretary shall 
establish and administer a program to certify clinical countermeasures 
delivery centers as qualified clinical countermeasures delivery centers 
for purposes of ensuring that--
            (1) the coordinated development, implementation, and 
        evaluation of clinical countermeasures will precede and follow 
        the utilization of the clinical countermeasures developed under 
        this Act (or the amendments made by this Act) or otherwise 
        available to respond to a biological, chemical, nuclear, 
        radiological, or explosive event or other emergency situation; 
        and
            (2) such countermeasures are delivered to affected and at-
        risk populations within a therapeutically effective time 
        period.
    (b) Application.--
            (1) In general.--To be certified as a qualified clinical 
        countermeasures delivery center, a clinical countermeasures 
        delivery center shall submit to the Assistant Secretary an 
        application at such time, in such manner, and containing such 
        information as the Assistant Secretary shall require.
            (2) Approval.--In determining whether to approve an 
        application under paragraph (1), the Assistant Secretary shall 
        ensure that the clinical countermeasures delivery center is in 
        compliance with the criteria developed pursuant to section 
        2403.
    (c) Requirements.--Upon approval of an application under subsection 
(b), a qualified clinical countermeasures delivery center within a 
specified geographic area and representing an affected or at risk 
population, shall--
            (1) during the pre-event phase, develop, test (through 
        exercises), and have in place plans for clinical 
        countermeasures delivery, in accordance with section 2404;
            (2) during the pre-event phase, prepare, test, and have in 
        place plans to develop new, and to maintain existing, 
        collaborations with members of the healthcare delivery and 
        response community;
            (3) during the event phase, deliver clinical 
        countermeasures to affected and at-risk populations in a 
        therapeutically effective time period and provide medical 
        management and treatment of adverse events arising from 
        utilization of clinical countermeasures developed in response 
        to an emergency situation;
            (4) during the event phase, communicate preliminary 
        findings regarding the delivery and efficacy of clinical 
        countermeasures to appropriate Federal, State, and local public 
        health authorities;
            (5) during the post event phase, have in place a validated 
        process of metrics and measures for evaluating the 
        effectiveness of clinical countermeasures through clinical 
        research, including external evaluation, quality assurance and 
        mitigation, and an evaluation of the clinical countermeasures 
        delivery center's capability to respond to the needs of 
        populations at risk and address potential hazard 
        vulnerabilities; and
            (6) during the post-even phase, share information about the 
        effectiveness of countermeasures and the capability of the 
        countermeasure delivery centers to respond to the event to 
        appropriate Federal, State, and local public health 
        authorities.
    (d) Standards.--The Assistant Secretary shall set standards to 
ensure that qualified clinical countermeasures delivery centers remain 
prepared to fulfill the functions described under this section in the 
event of an emergency situation.

SEC. 2403. ELIGIBILITY CRITERIA.

    (a) In General.--The Assistant Secretary shall establish by 
regulation criteria for the certification of clinical countermeasures 
delivery centers as qualified clinical countermeasures delivery centers 
for purposes of this title.
    (b) Minimum Qualifications.--The criteria developed under 
subsection (a) shall require that a qualified clinical countermeasures 
delivery center--
            (1) be a nonprofit healthcare provider that is directly 
        affiliated with an accredited medical teaching institution, 
        accredited school of public health, or an institution of higher 
        education (as defined by section 101(a) of the Higher Education 
        Act of 1965 (20 U.S.C. 1001(a))); and
            (2) have in place--
                    (A) plans for clinical countermeasures delivery in 
                accordance with section 2404;
                    (B) collaborating agreements with members of its 
                healthcare delivery and response community;
                    (C) plans to participate annually in at least 1 
                major exercise of plans and systems demonstrating 
                coordination among representatives of its healthcare 
                delivery and response community, as evaluated by the 
                Secretary;
                    (D) operating and managing clinical plans to 
                deliver healthcare to affected and at risk populations 
                in response to an emergency situation; and
                    (E) a validated process--
                            (i) of metrics and measures for evaluating 
                        the effectiveness of the delivery center's 
                        capability to meet the needs of affected and at 
                        risk populations and address potential 
                        vulnerabilities to hazards; and
                            (ii) for sharing the results and data from 
                        the plans and activities required under this 
                        subsection.

SEC. 2404. POLICIES, PROCEDURES, AND PROTOCOLS FOR THE DELIVERY OF 
              CLINICAL COUNTERMEASURES.

    (a) In General.--The Assistant Secretary, in consultation with the 
Commissioner of the Food and Drug Administration, the Director of the 
Centers for Disease Control and Prevention, the Health Resources 
Services Administration, the Commissioner of Medicare and Medicaid, and 
other regulatory and accreditation agencies, as appropriate, shall 
establish policies, procedures, and protocols to ensure the coordinated 
delivery of clinical countermeasures as described in section 2402(c).
    (b) Description.--The policies, procedures, and protocols 
established under subsection (a) shall be designed to--
            (1) foster cooperation and coordination among qualified 
        clinical countermeasures delivery centers;
            (2) ensure the implementation, delivery and evaluation of 
        clinical countermeasures among the healthcare delivery and 
        response community; and
            (3) identify and address the clinical, operational, 
        ethical, and legal issues that may arise during an emergency 
        situation.
    (c) Duties of Centers.--The qualified clinical countermeasures 
delivery centers shall--
            (1) meet the requirements described in subparagraphs (A) 
        and (B) of section 2403(b)(2);
            (2) participate annually in at least 1 major exercise of 
        plans and systems demonstrating the coordination of clinical 
        countermeasures among representatives of its healthcare 
        delivery and response community;
            (3) have in place operating and clinical plans--
                    (A) to deliver clinical countermeasures within a 
                therapeutically effective time period to affected and 
                at risk populations in response to an emergency 
                situation; and
                    (B) for the medical management and treatment of 
                adverse events arising from utilization of clinical 
                countermeasures developed in response to an emergency 
                situation; and
            (4) have in place a validated process--
                    (A) of metrics and measures for--
                            (i) evaluating the effectiveness of 
                        clinical countermeasures, including external 
                        evaluation, quality assurance, and mitigation; 
                        and
                            (ii) evaluating the clinical 
                        countermeasures delivery center's capability to 
                        meet the needs of affected and at risk 
                        populations and address potential 
                        vulnerabilities to hazards; and
                    (B) for sharing the results and data from the plans 
                and activities required under this subsection.

SEC. 2405. INCENTIVES FOR QUALIFIED CLINICAL COUNTERMEASURES DELIVERY 
              CENTERS.

    A clinical countermeasures delivery center that is certified by the 
Assistant Secretary as a qualified clinical countermeasures delivery 
center--
            (1) shall be entitled to reimbursement--
                    (A) for the costs associated with preparedness for 
                clinical countermeasures delivery and maintaining 
                readiness for a healthcare emergency requiring the use 
                of clinical countermeasures, including training 
                exercises and educational programs;
                    (B) for costs associated with the implementation, 
                delivery, and evaluation of clinical countermeasures in 
                the event of a healthcare emergency in which clinical 
                countermeasures, including those developed under this 
                Act (or the amendments made by this Act), are utilized; 
                and
                    (C) for costs associated with the post-event 
                initiatives involved with the delivery of clinical 
                countermeasures in the event of a healthcare emergency 
                in which clinical countermeasures, including those 
                developed under this Act (or the amendments made by 
                this Act), are utilized; and
            (2) at the discretion of the Assistant Secretary, may 
        receive 1 or more of the following:
                    (A) Bonus payment under the Medicare program under 
                title XVIII of the Social Security Act (42 U.S.C. 1395 
                et seq.) for the reimbursement of expenditures incurred 
                in connection with the implementation of activities 
                under this title.
                    (B) Increased graduate medical education 
                reimbursement for expenditures incurred in connection 
                with the implementation of activities under this title.
                    (C) The application and receipt of surcharges with 
                respect to reimbursements under the Medicare or 
                Medicaid programs under title XVIII or XIX of the 
                Social Security Act (42 U.S.C. 1395 or 1396 et seq.) 
                paid to the qualified clinical countermeasures delivery 
                centers.
                    (D) Participation in a program to receive temporary 
                personnel replacements, salary reimbursements, and 
                training cost reimbursement, to be applied to the 
                personnel of qualified clinical countermeasures 
                delivery centers that choose to obtain specialized 
                training in emergency preparedness or that want to 
                obtain special certifications.
                    (E) Malpractice and tort liability indemnification 
                for the qualified clinical countermeasures delivery 
                centers and the personnel supporting such centers for 
                legal fees and judgments incurred in connection with 
                the implementation of activities under this title.
                    (F) Worker's compensation indemnification with 
                respect to qualified clinical countermeasures delivery 
                centers' personnel in connection with the 
                implementation of programs under this title during 
                periods of training and emergency situations.
                    (G) Notwithstanding the requirements of section 
                1867 of the Social Security Act (42 U.S.C. 1395dd), 
                commonly known as the Emergency Medical Treatment and 
                Active Labor Act, the ability of qualified clinical 
                countermeasures delivery centers to pre-triage patients 
                during an emergency situation, including triaging based 
                on nonemergent conditions to other hospitals, 
                ambulatory facilities, or other appropriate healthcare 
                entities.
                    (H) Indemnification by the Federal Government for 
                legal fees incurred by the qualified clinical 
                countermeasures delivery centers during an emergency 
                situations, as well as worker's compensation and 
                overall liability coverage during such a situation and 
                during periods of training.
                    (I) The assistance of Federal personnel or armed 
                forces personnel for the planning and support of 
                training and training exercises for the personnel of 
                the qualified clinical countermeasures delivery 
                centers.
                    (J) The provision of family support services for 
                workers, including emergency management and public 
                health agencies personnel, supporting the center during 
                an emergency situation to allow for communication 
                access to such workers during such situation, priority 
                standing for access to vaccines and other recommended 
                interventions, and other services to help workers 
                function effectively in such a situation.

SEC. 2406. AUTHORIZATION OF APPROPRIATIONS.

    There are authorized to be appropriated such sums as may be 
necessary to carry out this title.

         TITLE XXV--CENTERS FOR DISEASE CONTROL AND PREVENTION

SEC. 2501. GLOBAL DISEASE DETECTION TRUST FUND.

    (a) In General.--
            (1) Establishment of fund.--There is established within the 
        Centers for Disease Control and Prevention a Global Disease 
        Detection Trust Fund (referred to in this title as the 
        ``Detection Trust Fund'').
            (2) Administration.--The Detection Trust Fund shall be 
        administered by the Director of the Centers for Disease Control 
        and Prevention.
            (3) Purposes.--The purposes of the Detection Trust Fund are 
        to--
                    (A) detect, verify, and respond to infectious 
                disease outbreaks around the world more quickly, 
                including threats such as avian influenza and the 
                development of antimicrobial resistance that emerge 
                outside the United States;
                    (B) control intentional or naturally occurring 
                health threats at their origin and prevent 
                international spread;
                    (C) protect the health and safety of United States 
                citizens and officials traveling or living abroad; and
                    (D) protect the economic interests of the United 
                States and its partners from threats to health.
    (b) Use of Fund.--
            (1) In general.--The Director of the Centers for Disease 
        Control and Prevention may expend not more than $250,000,000 in 
        each fiscal year from the Detection Trust Fund on global 
        disease detection activities, which may include--
                    (A) conducting--
                            (i) disease surveillance activities;
                            (ii) field investigations;
                            (iii) training and development activities; 
                        and
                            (iv) research on methods and approaches for 
                        detection and control of threats to health 
                        described in subsection (a)(3);
                    (B) developing information and communications 
                technology;
                    (C) improving infectious disease epidemiology;
                    (D) providing technical assistance for disease 
                prevention and control programs;
                    (E) ensuring the capacity to prepare for and 
                respond to emerging and unknown public health threats 
                and emergencies; and
                    (F) developing and maintaining of laboratory 
                capacity.
            (2) Limitation.--Amounts expended from the Detection Trust 
        Fund shall not be funded through reductions in the annual 
        appropriations for related activities of the Centers for 
        Disease Control and Prevention.
    (c) Authorization of Appropriations.--There are authorized to be 
appropriated $1,250,000,000 to the Detection Trust Fund to carry out 
this section.

SEC. 2502. ENVIRONMENTAL MICROBIOLOGY FACILITY STUDY AND REPORT.

    Not later than 6 months after the date of enactment of this Act, 
the Director of the Centers for Disease Control and Prevention shall--
            (1) conduct a study on the feasibility of developing an 
        environmental microbiology facility as part of the National 
        Interagency Biodefense Campus at Fort Detrick, Maryland; and
            (2) submit to Congress a report that describes the findings 
        of the study under paragraph (1), including--
                    (A) the need for such a facility and the potential 
                benefits of developing such a facility as part of the 
                Interagency campus;
                    (B) the feasibility of constructing such a 
                facility, and
                    (C) the projected cost and timetable for the 
                construction of such a facility.

SEC. 2503. ENFORCEMENT OF QUARANTINES.

    (a) Penalties.--Section 368 (42 U.S.C. 271) is amended--
            (1) in subsection (a), by striking ``$1,000 or by 
        imprisonment for not more than one year'' and inserting 
        ``$250,000 or by imprisonment for not more than 10 years''; and
            (2) in subsection (b), by striking ``$5,000'' and inserting 
        ``$1,000,000''.
    (b) Panel Physician Quality Control.--Section 361 of the Public 
Health Service Act (42 U.S.C. 264) is amended by adding at the end the 
following:
    ``(f) Where the United States enters into agreements, contracts, or 
other arrangements with physicians or other healthcare providers and 
laboratories in foreign countries for the purpose of conducting health 
screening on aliens seeking temporary or permanent residence in the 
United States, the Secretary shall evaluate each such physician or 
provider on an annual basis to certify that the physician or provider 
adequately complies with applicable regulations governing the medical 
screening of applicants for entry into the United States. The Secretary 
may assess certification or user fees to support the annual evaluation, 
quality control, and certification of panel physicians performing such 
foreign medical screenings.''.

SEC. 2504. EDUCATIONAL CAMPAIGN AT THE CENTERS FOR DISEASE CONTROL AND 
              PREVENTION.

    (a) In General.--The Director of the Centers for Disease Control 
and Prevention shall, in consultation with relevant stakeholders, carry 
out a 2-phase, national educational campaign to make available 
information about the possible public health measures that might be 
implemented in the event of a pandemic outbreak or a bioterror attack 
involving an infectious disease.
    (b) Campaign Content.--
            (1) In general.--The campaign established under subsection 
        (a) may include information regarding--
                    (A) the circumstances under which a range of public 
                health measures might be implemented;
                    (B) the concepts of person-to-person spread, 
                quarantine, isolation, and movement restriction;
                    (C) mass pre- and post-exposure prophylaxis, the 
                use of off-label drugs, and other extraordinary 
                measures to protect the public health;
                    (D) the rationale and benefits to the public of 
                implementing such public health measures; and
                    (E) the legal rights of citizens in the event such 
                public health measures are implemented.
            (2) Campaign phase 1.--
                    (A) In general.--In Phase 1 of the campaign 
                established under subsection (a), the Director of the 
                Centers for Disease Control and Prevention shall 
                consult with a diverse advisory panel in the 
                preparation of nationally standardized messages and 
                guidance about the range of medical and nonmedical 
                interventions to interrupt disease transmission.
                    (B) Composition of advisory panel.--The advisory 
                panel consulted under subparagraph (A) shall include--
                            (i) representatives of State and local 
                        governments and nongovernmental public health 
                        agencies;
                            (ii) public health experts and medical 
                        practitioners who have real-world experience in 
                        crisis management and risk communication;
                            (iii) business leaders;
                            (iv) members of the lay public; and
                            (v) subject matter experts in bioethics, 
                        risk communication, health education, community 
                        organization, advertising, and public 
                        relations.
                    (C) Collection of information.--To direct the 
                deliberations of the advisory panel, the Director of 
                the Centers for Disease Control and Prevention shall 
                collect and synthesize extant information regarding 
                community-level disease containment measures, including 
                assessment of interventions during the SARS outbreak.
            (3) Campaign phase 2.--
                    (A) Purpose.--The purpose of Phase 2 of the 
                campaign established under subsection (a) shall be to 
                augment at the State and local level nationally 
                standardized messages to address specific community 
                needs and concerns.
                    (B) Establishment of grant.--
                            (i) In general.--The Director of the 
                        Centers for Disease Control and Prevention 
                        shall award grants to 5 local health 
                        departments (that are regionally and 
                        demographically diverse) to design and deliver 
                        educational campaigns targeted for their 
                        community with respect to the plans of the 
                        health departments for implementing a range of 
                        public health interventions in the context of a 
                        pandemic outbreak or biological attack.
                            (ii) Application.--Local public health 
                        departments shall submit to the Secretary an 
                        application to receive a grant under clause (i) 
                        at such time, in such manner, and containing 
                        such information as the Secretary may require.
    (c) Authorization of Appropriations.--There are authorized to be 
appropriated $20,000,000 for each of fiscal years 2006 through 2010 to 
carry out this section.

               TITLE XXVI--ZOONOTIC DISEASE SURVEILLANCE

SEC. 2601. ZOONOTIC DISEASE SURVEILLANCE.

    (a) Findings.--Congress makes the following findings:
            (1) Seventy percent of the known bioterrorist agents are 
        zoonotic.
            (2) Emerging infectious diseases such as SARS, monkeypox, 
        and West Nile virus have emerged from animal origins.
            (2) Early warning of impending zoonotic disease outbreaks 
        has failed in sentinel animal populations during zoonotic 
        outbreaks such as SARS, monkeypox, and West Nile virus.
            (3) There is no way to predict what species might serve as 
        sentinels in emerging infectious diseases or bioterrorist 
        events.
            (4) Many animals, such as dogs, cats, and exotic pets, do 
        not fall under the jurisdiction of any Federal agency.
            (5) There is a lack of focus on the detection of zoonotic 
        threats in sentinel or reservoir animal populations prior to 
        human involvement.
            (6) There is a continued inability to share real-time data 
        across the human and veterinary agencies on zoonotic threats.
    (b) Establishment of Working Group.--The Secretary of Homeland 
Security, in consultation with the Secretary of Health and Human 
Services, the Secretary of Agriculture, the Secretary of the Interior, 
and the Secretary of Defense shall establish a Zoonotic Disease Working 
Group within the Department of Homeland Security (referred to in this 
section as the ``Working Group'').
    (c) Duties of Working Group.--
            (1) In general.--The Working Group shall conduct a study of 
        all matters relating to the creation of an integrated (human 
        and animal) real-time zoonotic disease surveillance network and 
        make recommendations that address gaps in surveillance 
        activities.
            (2) Matters studied.--The Working Group shall--
                    (A) evaluate the status of zoonotic disease 
                surveillance by Federal agencies and the private sector 
                as of the date of enactment of this Act;
                    (B) identify--
                            (i) existing bioterrorism funds in Federal 
                        and State agencies;
                            (ii) budgets that could be redirected 
                        toward improving the ability to detect and 
                        report zoonotic threats across species handled 
                        by veterinary and wildlife institutions; and
                            (iii) existing laboratory facilities for 
                        zoo animals, pets, and exotic collections that 
                        could be networked, equipped, and funded for 
                        such purpose; and
                    (C) consult private sector representatives, 
                including those with expertise on non-agricultural 
                species, exotic pets, and zoo animals, representatives 
                of State and local public health agencies, and 
                representatives from veterinarians and laboratories.
            (3) Submission of report.--Not later than 8 months after 
        the date of enactment of this Act, the Working Group shall 
        submit a report to the Secretary of Homeland Security with 
        respect to its findings and recommendations under this section.

           TITLE XXVII--COUNTERMEASURES AGAINST AGROTERRORISM

SEC. 2701. FINDINGS.

    Congress finds that--
            (1) agriculture is important to the social and economic 
        stability of the United States;
            (2) in 2001, food production constituted 9.7 percent of the 
        gross domestic product of the United States, generating cash 
        receipts in excess of $991,000,000,000;
            (3) the agriculture production and food industries are 
        vulnerable to deliberate agroterrorist acts and naturally 
        occurring disease disruption;
            (4) practices that heighten this vulnerability include--
                    (A) the highly intensive and concentrated nature of 
                agribusiness in the United States, which increases the 
                potential speed with which a disease can spread;
                    (B) the insufficiency of agricultural security 
                methods and biosurveillance technologies;
                    (C) the hesitancy of producers to report disease 
                outbreaks for fear of uncompensated culling or 
                quarantine;
                    (D) the declining pool of veterinarians and 
                diagnosticians trained to recognize foreign animal 
                diseases;
                    (E) larger breeding herds, which reduce individual 
                animal health observations and may cause illnesses to 
                remain undetected; and
                    (F) inadequate laboratory diagnostic capability at 
                the national and local levels;
            (5)(A) countermeasures should be developed to both prevent 
        and control agroterrorism;
            (B) incentives under title III (and amendments made by that 
        title) should be made available to persons who develop and 
        manufacture those countermeasures;
            (C) threats to biosecurity should be identified through 
        cooperative decisions made by the Secretary and the Secretary 
        of Homeland Security;
            (D) the Secretary regulates and approves biological and 
        chemical agents and toxins under the Virus-Serum-Toxin Act (21 
        U.S.C. 151 et seq.); and
            (E) the Secretary of Health and Human Services, acting 
        through the Center for Veterinary Medicine of the Food and Drug 
        Administration, regulates and approves new animal drugs under 
        section 512 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360b);
            (6) preventative countermeasures (including all equipment, 
        materials, drugs, personnel, and training necessary to 
        interdict the spread of animal and plant diseases efficiently 
        and effectively) should include--
                    (A) increased funding for the Animal and Plant 
                Health Inspection Service to increase training and 
                better protect the borders of the United States;
                    (B) increased funding for exotic animal and plant 
                disease research conducted in countries in which exotic 
                diseases are endemic;
                    (C) improved use, by persons under contract with 
                the Federal Government to develop countermeasures, of 
                appropriate containment facilities controlled by the 
                Federal Government (such as the National Veterinary 
                Disease Laboratory in Ames, Iowa or Plum Island, New 
                York); and
                    (D) increased funding for vaccine and antibiotic 
                research;
            (7) control countermeasures should include--
                    (A) recruiting, training, and equipping field 
                personnel;
                    (B) developing rapid and specific diagnostic tests;
                    (C) developing a stockpile of countermeasures to 
                biological and chemical agents and toxins of 
                consequence to the agricultural community, as 
                determined by the Secretary, with adequate funding for 
                the development of the stockpile;
                    (D) researching and stockpiling of antiviral, 
                antifungal, antibacterial, and vector control agents; 
                and
                    (E) a national system of livestock identification 
                and movement surveillance; and
            (8) an effective system of countermeasures against 
        agroterrorism will require initial centralization followed by 
        dissemination of policies and practices to a local level.

SEC. 2702. DEFINITIONS.

    In this Act:
            (1) Agricultural disease.--The term ``agricultural 
        disease'' means an outbreak of a plant or animal disease, or a 
        pest infestation, that requires prompt action in order to 
        prevent injury or damage to people, plants, livestock, 
        property, the economy, or the environment.
            (2) Agricultural disease emergency.--The term 
        ``agricultural disease emergency'' means an agricultural 
        disease that the Secretary determines to be an emergency 
        under--
                    (A) section 415 of the Plant Protection Act (7 
                U.S.C. 7715); or
                    (B) section 10407(b) of the Animal Health 
                Protection Act (7 U.S.C. 8306(b)).
            (3) Agriculture.--The term ``agriculture'' includes--
                    (A) the science and practice of activities relating 
                to food, feed, and fiber production, processing, 
                marketing, distribution, use, and trade;
                    (B) family and consumer science, nutrition, food 
                science and engineering, agricultural economics, and 
                other social sciences; and
                    (C) forestry, wildlife science, fishery science, 
                aquaculture, floraculture, veterinary medicine, and 
                other environmental and natural resource sciences.
            (4) Agroterrorism.--The term ``agroterrorism'' means the 
        commission of an agroterrorist act.
            (5) Agroterrorist act.--The term ``agroterrorist act'' 
        means a criminal act consisting of causing or attempting to 
        cause damage or harm to, or destruction or contamination of, a 
        crop, livestock, farm or ranch equipment, material or property 
        associated with agriculture, or a person engaged in 
        agricultural activity, that is committed with the intent--
                    (A) to intimidate or coerce a civilian population; 
                or
                    (B) to influence the policy of a government by 
                intimidation or coercion.
            (6) Biosecurity.--
                    (A) In general.--The term ``biosecurity'' means 
                protection from the risks posed by biological, 
                chemical, or radiological agents to--
                            (i) plant or animal health;
                            (ii) the agricultural economy;
                            (iii) the environment; or
                            (iv) human health.
                    (B) Inclusions.--The term ``biosecurity'' includes 
                the exclusion, eradication, and control of biological 
                agents that cause plant or animal diseases.
            (7) Countermeasure.--The term ``countermeasure'' has the 
        meaning given that term in section 319F-3 of the Public Health 
        Service Act (as added by section 202).
            (8) Indian tribe.--The term ``Indian tribe'' has the 
        meaning given the term in section 4 of the Indian Self-
        Determination and Education Assistance Act (25 U.S.C. 450b).
            (9) Secretary.--The term ``Secretary'' means the Secretary 
        of Agriculture.
            (10) Tribal government.--The term ``tribal government'' 
        means the governing body of an Indian tribe.

SEC. 2703. ESTABLISHMENT OF WORKING GROUP.

    The Secretary, in consultation with the Secretary of Health and 
Human Services and the Secretary of Homeland Security, shall establish 
a working group (referred to in this title as the ``Working Group'') 
that shall include representatives of--
            (1) appropriate agencies of the Department of Agriculture, 
        appointed by the Secretary;
            (2) the Centers for Disease Control and Prevention, 
        appointed by the Secretary of Health and Human Services;
            (3) the Center for Veterinary Medicine of the Food and Drug 
        Administration, appointed by the Secretary of Health and Human 
        Services, in consultation with the Secretary of Defense and the 
        Secretary of Homeland Security;
            (4) the Department of Homeland Security, appointed by the 
        Secretary of Homeland Security; and
            (5) the Animal Health Institute.

SEC. 2704. DUTIES.

    (a) Study.--
            (1) In general.--The Working Group shall conduct a study of 
        all matters relating to developing countermeasures against 
        agroterrorism in the United States.
            (2) Matters to be studied.--The matters to be studied by 
        the Working Group shall include--
                    (A) the nature of United States preparedness for 
                agroterrorism threats to crops and livestock in the 
                United States, including an evaluation of the progress 
                of ongoing research, studies, and programs;
                    (B) the availability of countermeasures against 
                agroterrorism threats;
                    (C) the strategy used to develop such qualified 
                countermeasures to both prevent and control an 
                agroterrorism threat;
                    (D) the appropriateness of adapting the incentives 
                established by the amendments made by the Project 
                BioShield Act of 2004 (118 Stat. 835) and by this Act 
                (including amendments made by this Act), to such 
                countermeasures against agroterrorism;
                    (E) whether technological innovation is required to 
                complete the identification, border security, and 
                transit surveillance of livestock;
                    (F) the appropriateness of entering into bilateral 
                agreements with countries in which exotic animal 
                disease vaccines that are approved by the Department of 
                Agriculture are produced in order to provide for the 
                use of the vaccines by the United States in the case of 
                an emergency;
                    (G) the feasibility of producing certain vaccines, 
                especially vaccines for foot and mouth disease, in the 
                continental United States;
                    (H) the feasibility of leasing Plum Island, New 
                York, for use as a commercial vaccine production 
                facility; and
                    (I) the provision of funds for the Agency for 
                International Development to establish an office of 
                animal and plant health, the mission of which is to 
                assist countries in controlling and eradicating 
                diseases that pose a threat to agriculture in the 
                United States.
    (b) Recommendations.--The Working Group shall develop 
recommendations on--
            (1) specific requirements needed to accelerate the 
        development of countermeasures against agroterrorism, including 
        research tools, biologics, and therapeutics; and
            (2) if the Working Group determines that the commercial 
        agricultural industry is incapable or has inadequate resources 
        to fulfill the biosecurity needs of the United States, adapting 
        the incentives described in subparagraph (D) of subsection 
        (a)(2).
    (c) Report.--Not later than 1 year after the date of enactment of 
this Act, the Working Group shall submit to the appropriate committees 
of Congress a report that contains--
            (1) a detailed statement of the findings and conclusions of 
        the Working Group; and
            (2) the recommendations of the Working Group for such 
        legislation and administrative actions as the Working Group 
        considers appropriate.

SEC. 2705. STATE AND LOCAL ASSISTANCE.

    (a) Study.--
            (1) In general.--In consultation with the steering 
        committee of the National Animal Health Emergency Management 
        System and other stakeholders, the Secretary shall conduct a 
        study to--
                    (A) determine the best use of epidemiologists, 
                animal and plant pathologists, computer modelers, and 
                statisticians as members of emergency response task 
                forces that handle foreign or emerging agricultural 
                disease emergencies; and
                    (B) identify the types of data that are necessary 
                for proper modeling and analysis of agricultural 
                disease emergencies.
            (2) Report.--Not later than 180 days after the date of 
        enactment of this Act, the Secretary shall submit a report that 
        describes the results of the study under paragraph (1) to--
                    (A) the Secretary of Homeland Security; and
                    (B) the head of any other agency involved in 
                response planning for agricultural disease emergencies.
    (b) Geographic Information System Grants.--
            (1) In general.--The Secretary, in consultation with the 
        Secretary of Homeland Security and the Secretary of the 
        Interior, shall establish a program under which the Secretary 
        shall provide grants to States and local governments to develop 
        capabilities to use a geographic information system or 
        statistical model for an epidemiological assessment in the 
        event of an agricultural disease emergency.
            (2) Authorization of appropriations.--There are authorized 
        to be appropriated such sums as may be necessary to carry out 
        this subsection.
    (c) Grants To Facilitate Participation of State and Local Animal 
and Plant Healthcare Officials.--
            (1) In general.--The Secretary of Homeland Security, in 
        coordination with the Secretary, shall establish a program 
        under which the Secretary of Homeland Security shall provide 
        grants to communities to facilitate the participation of State 
        and local animal and plant healthcare officials in community 
        emergency planning efforts.
            (2) Authorization of appropriations.--There is authorized 
        to be appropriated such sums as may be necessary to carry out 
        this subsection.
    (d) Biosecurity Awareness and Programs.--
            (1) In general.--The Secretary shall implement a public 
        awareness campaign for farmers, ranchers, and other 
        agricultural producers that emphasizes--
                    (A) the need for heightened biosecurity on farms; 
                and
                    (B) reporting to the Department of Agriculture any 
                agricultural disease anomaly.
            (2) On-farm biosecurity.--
                    (A) In general.--Not later than 240 days after the 
                date of enactment of this Act, the Secretary, in 
                consultation with associations of agricultural 
                producers and taking into consideration research 
                conducted under the National Agricultural Research, 
                Extension, and Teaching Policy Act of 1977 (7 U.S.C. 
                3101 et seq.), shall--
                            (i) develop guidelines--
                                    (I) to improve monitoring of 
                                vehicles and materials entering or 
                                leaving farm or ranch operations; and
                                    (II) to control human traffic 
                                entering or leaving farm or ranch 
                                operations; and
                            (ii) distribute the guidelines developed 
                        under clause (i) to agricultural producers 
                        through agricultural informational seminars and 
                        biosecurity training sessions.
                    (B) Authorization of appropriations.--
                            (i) In general.--There are authorized to be 
                        appropriated such sums as may be necessary to 
                        carry out this paragraph.
                            (ii) Information program.--Of the amounts 
                        made available under clause (i), the Secretary 
                        may use such sums as are necessary to establish 
                        in each State an information program to 
                        distribute the biosecurity guidelines developed 
                        under subparagraph (A)(i).
            (3) Biosecurity grant pilot program.--
                    (A) Incentives.--
                            (i) In general.--Not later than 240 days 
                        after the date of enactment of this Act, the 
                        Secretary shall develop a pilot program to 
                        provide incentives, in the form of grants or 
                        low-interest loans, to agricultural producers 
                        to restructure farm and ranch operations (based 
                        on the biosecurity guidelines developed under 
                        paragraph (2)(A)(i)) to achieve the goals 
                        described in clause (ii).
                            (ii) Goals.--The goals referred to in 
                        clause (i) are--
                                    (I) to control access to farms and 
                                ranches by persons intending to commit 
                                agroterrorist acts;
                                    (II) to prevent the introduction 
                                and spread of agricultural diseases; 
                                and
                                    (III) to take other measures to 
                                ensure biosecurity.
                            (iii) Limitation.--The amount of a grant or 
                        low-interest loan provided under this paragraph 
                        shall not exceed $10,000.
                    (B) Report.--Not later than 3 years after the date 
                of enactment of this Act, the Secretary shall submit to 
                Congress a report that--
                            (i) describes the implementation of the 
                        pilot program; and
                            (ii) makes recommendations for expanding 
                        the pilot program.
                    (C) Authorization of appropriations.--There are 
                authorized to be appropriated such sums as may be 
                necessary to carry out this paragraph.

SEC. 2706. INTERAGENCY COORDINATION.

    (a) Agricultural Disease Liaisons.--
            (1) Agricultural disease management liaison.--The Secretary 
        of Homeland Security shall establish a senior level position 
        within the Federal Emergency Management Agency the primary 
        responsibility of which is to serve as a liaison for 
        agricultural disease management between--
                    (A) the Department of Homeland Security; and
                    (B)(i) the Federal Emergency Management Agency;
                    (ii) the Department of Agriculture;
                    (iii) other Federal agencies responsible for a 
                response to an emergency relating to an agriculture 
                disease;
                    (iv) the emergency management community;
                    (v) State emergency and agricultural officials;
                    (vi) tribal governments; and
                    (vii) industries affected by agricultural disease.
            (2) Animal health care liaison.--The Secretary of Health 
        and Human Services shall establish within the Department of 
        Health and Human Services a senior level position the primary 
        responsibility of which is to serve as a liaison between--
                    (A) the Department of Health and Human Services; 
                and
                    (B)(i) the Department of Agriculture;
                    (ii) the animal health community;
                    (iii) the emergency management community;
                    (iv) tribal governments; and
                    (v) industries affected by agricultural disease.
    (b) Transportation.--
            (1) In general.--The Secretary of Transportation, in 
        consultation with the Secretary and the Secretary of Homeland 
        Security, shall--
                    (A) publish in the Federal Register proposed 
                guidelines for restrictions on interstate 
                transportation of an agricultural commodity or product 
                in response to an agricultural disease;
                    (B) provide for a comment period of not less than 
                90 days for the proposed guidelines; and
                    (C) establish final guidelines, taking into 
                consideration any comment received under subparagraph 
                (B); and
            (2) provide the guidelines described in paragraph (1) to 
        officers and employees of--
                    (A) the Department of Agriculture;
                    (B) the Department of Transportation; and
                    (C) the Department of Homeland Security.

SEC. 2707. REGIONAL, STATE, AND LOCAL PREPAREDNESS.

    (a) Environmental Protection Agency.--The Administrator of the 
Environmental Protection Agency, in consultation with the Secretary, 
shall cooperate with regional, State, and local disaster preparedness 
officials to include consideration of the potential environmental 
effects of a response activity in planning a response to an 
agricultural disease.
    (b) Department of Agriculture.--The Secretary, in consultation with 
the Secretary of Homeland Security, shall--
            (1) develop and implement procedures to provide information 
        to, and share information among, Federal, regional, State, 
        tribal, and local officials regarding agricultural threats, 
        risks, and vulnerabilities; and
            (2) cooperate with State agricultural officials, State and 
        local emergency managers, representatives from State land grant 
        colleges and research universities, agricultural producers, and 
        agricultural trade associations to establish local response 
        plans for agricultural diseases.
    (c) Federal Emergency Management Agency.--The Director of the 
Federal Emergency Management Agency, in consultation with the 
Secretary, shall--
            (1) establish a task force consisting of agricultural 
        producers and State and local emergency response officials to 
        identify the best practices for regional and State agricultural 
        disease programs;
            (2) distribute to States, tribal governments, and 
        localities a report that describes the best practices 
        identified under paragraph (1); and
            (3) design packages containing exercises for training, 
        based on the identified best practices, in the form of printed 
        materials and electronic media, for distribution to State and 
        local emergency managers, State agricultural officials, and 
        tribal government officials.

SEC. 2708. INTERNATIONAL ACTIVITIES.

    (a) International Agricultural Disease Surveillance.--Not later 
than 1 year after the date of enactment of this Act, the Secretary, in 
consultation with the Secretary of State and the Administrator of the 
Agency for International Development, shall submit to Congress a report 
that describes measures taken by the Secretary to--
            (1) streamline the process of notification by the Secretary 
        to Federal agencies in the event of an agricultural disease in 
        a foreign country; and
            (2) cooperate with representatives of foreign countries, 
        international organizations, and industry to develop and 
        implement methods of sharing information relating to 
        international agricultural diseases and unusual agricultural 
        activities.
    (b) Inspections of Imported Agricultural Products.--The Secretary 
of Homeland Security shall--
            (1) cooperate with the Secretary and any appropriate 
        Federal intelligence official to improve the ability of the 
        Department of Agriculture to identify agricultural commodities 
        and products, livestock, and other goods imported from suspect 
        locations that are recognized by the intelligence community 
        as--
                    (A) having experienced an agricultural terrorist 
                activity or an unusual agricultural disease; or
                    (B) harboring or having harbored an agroterrorist; 
                and
            (2) use the information described in paragraph (1) to 
        establish priorities for inspecting imported agricultural 
        products.
    (c) Bilateral Mutual Assistance Agreements.--The Secretary of 
State, in coordination with the Secretary and the Secretary of Homeland 
Security, shall--
            (1) enter into mutual assistance agreements with other 
        countries to provide and receive assistance in the event of an 
        agricultural disease, including--
                    (A) training for veterinarians and agriculture 
                specialists of the United States in the identification, 
                diagnosis, and control of foreign agricultural 
                diseases;
                    (B) providing resources and personnel to a foreign 
                government with limited resources to respond to an 
                agricultural disease; and
                    (C) bilateral training programs and exercises 
                relating to assistance provided under this paragraph; 
                and
            (2) provide funding for a program or exercise described in 
        paragraph (1)(C).

SEC. 2709. REVIEW OF LEGAL AUTHORITY.

    (a) In General.--The Attorney General, in consultation with the 
Secretary, shall conduct a review of State and local laws relating to 
agroterrorism and biosecurity to determine--
            (1) the extent to which the laws facilitate or impede the 
        implementation of a current or proposed response plan relating 
        to an agricultural disease;
            (2) whether an injunction issued by a State court could--
                    (A) delay the implementation of a Federal response 
                plan described in paragraph (1); or
                    (B) affect the extent to which an agricultural 
                disease spreads; and
            (3) the types and extent of legal evidence that may be 
        required by a State court before a response plan described in 
        paragraph (1) may be implemented.
    (b) Report.--Not later than 180 days after the date of enactment of 
this Act, the Attorney General shall submit to Congress a report that 
describes the results of the review under subsection (a) (including any 
recommendations of the Attorney General).

      TITLE XXVIII--GLOBAL DISTRIBUTION OF MEDICAL COUNTERMEASURES

SEC. 2801. FINDINGS.

    Congress finds the following:
            (1) Experience with infections diseases like HIV and 
        malaria in developing countries illustrate that the United 
        States must work with developing countries to plan for the 
        delivery of products developed under this Act (and the 
        amendments made by this Act).
            (2) For patients to benefit from these new medical 
        interventions, there must be health care providers to prescribe 
        and administer such interventions and assistance to purchase 
        the treatments.
            (3) The United States Agency for International Development 
        (referred to in this title as ``USAID'') should work with its 
        counterparts in other highly industrialized nations to gain 
        assistance in supplying such products. The Department of Health 
        and Human Services and USAID should undertake preapproval 
        planning and multilateral consensus building to assure optimal 
        outcomes for use of such products.

SEC. 2802. REPORT BY USAID.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Administrator of the United States Agency for 
International Development (referred to in this section as the 
``Administrator of USAID''), in consultation with the entities 
described under subsection (b), shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives the report 
described under subsection (c).
    (b) Consulting Entities.--In preparing the report under subsection 
(a), the Administrator of USAID shall consult with the following 
entities:
            (1) The Secretary of State.
            (2) The United States Global AIDS Coordinator and Office of 
        International Health Affairs.
            (3) The Director of the Centers for Disease Control and 
        Prevention.
            (4) The Commissioner of Food and Drugs.
            (5) The Surgeon General.
            (6) The Secretary of Homeland Security.
            (7) The Secretary of Defense.
            (8) The Director of the United States Peace Corps.
            (9) The World Health Organization.
            (10) The United Nations Children's Fund (UNICEF).
            (11) The United Nations Human Commissioner for Refugees 
        (UNHCR).
            (12) The Global Fund to fight HIV/AIDS, TB and Malaria.
            (13) The Global Alliance for Vaccines and Immunizations 
        (GAVI).
            (14) The International Committee of the Red Cross, the 
        International Federation of Red Cross and Red Crescent 
        Societies, and the American Red Cross.
            (15) Other non-profit non-government organizations and 
        foundations with expertise in the distribution of infectious 
        disease countermeasures.
    (c) Report.--
            (1) In general.--The report under subsection (a) shall 
        address--
                    (A) the global distribution of countermeasures 
                procured under the Project BioShield Act of 2004 
                (Public Law 108-276) and this Act (and the amendments 
                made by such Acts), particularly countermeasures to 
                infectious diseases that are not terror weapons and 
                that have a substantial incidence in developing 
                countries;
                    (B) the existing infrastructure with respect to 
                ensuring global distribution of such countermeasures; 
                and
                    (C) plans for strengthening the infrastructure 
                described under subparagraph (B) to ensure the 
                effective global distribution of such countermeasures.
            (2) Content of report.--The report under subsection (a) 
        shall include an analysis with respect to--
                    (A) the procedures by which the appropriate 
                officials at the Office of Public Health Countermeasure 
                Development of the Department of Health and Human 
                Services will notify USAID and other agencies of the 
                types, characteristics, quantity, and timing of the 
                countermeasures that may become available under the 
                Project BioShield Act of 2004 (Public Law 108-276) and 
                this Act (and the amendments made by such Acts);
                    (B) the types and sources of data upon which the 
                Government will rely in determining the numbers and 
                locations of specific populations that might benefit 
                from such countermeasures;
                    (C) the means for ensuring that such 
                countermeasures will be distributed in developing 
                countries that cannot purchase the countermeasures;
                    (D) the trade and regulatory barriers to the global 
                distribution of such countermeasures and 
                recommendations for removing such barriers;
                    (E) the appropriate--
                            (i) priorities for national and regional 
                        distribution of such countermeasures based on 
                        public health, medical, and other criteria;
                            (ii) terms for the transfer and sale of 
                        such countermeasures by the United States and 
                        other entities participating in a procurement 
                        pool established under section 319F-3 of the 
                        Public Health Service Act (as added by section 
                        202) to other governments or nongovernment 
                        organizations and individuals;
                            (iii) labels and information provided to 
                        public health officials and individuals 
                        regarding such countermeasures;
                            (iv) protocols for licensing of 
                        countermeasures distributed globally, and 
                        policies for distribution of unlicensed 
                        investigational countermeasures;
                            (v) protocols for assessing the safety and 
                        effectiveness of such countermeasures and any 
                        contraindications for the utilization of such 
                        countermeasures;
                            (vi) pre- and post-licensing clinical 
                        testing of such countermeasures;
                            (vii) strategy for minimizing the 
                        development of natural resistance to such 
                        countermeasures;
                            (viii) liability and indemnification 
                        policies associated with global distribution of 
                        countermeasures; and
                            (ix) protections for intellectual property 
                        associated with such countermeasures; and
                    (F) the appropriate protocols for ongoing 
                assessment of the effectiveness of the global 
                distribution strategy, including independent 
                assessments.
    (d) Assessment by the Director of the Centers for Disease Control 
and Prevention.--The Director of the Centers for Disease Control and 
Prevention shall submit as part of the report under subsection (a), an 
assessment of--
            (1) the existing public health infrastructure available to 
        participate in the global distribution of the countermeasures 
        described under subsection (c)(1) and the appropriate strategy 
        for strengthening the public health infrastructure necessary 
        for the global distribution of such countermeasures;
            (2) the capacity of international public health agencies to 
        respond to a pandemic or other public health emergency, 
        including distribution of such countermeasures and other 
        medical countermeasures and recommendations for strengthening 
        such capacity;
            (3) the existing information reporting and diagnostic and 
        detection systems regarding global infectious disease and 
        recommendations for strengthening such systems;
            (4) the capacity of international public health agencies to 
        establish and maintain quarantines or other isolation 
        strategies to contain outbreaks of infectious diseases and 
        recommendations for strengthening such capacity;
            (5) the long-term impact on health and chronic disease of 
        distributing such countermeasures;
            (6) the ability of the United States to provide long-term 
        medical and supportive care for victims of an infectious 
        disease, or adverse effects of a countermeasures;
            (7) the feasibility of creating a Strategic Global 
        Stockpile of countermeasures; and
            (8) the feasibility of initiating a global preparedness 
        fund for a global response to outbreaks of infectious diseases.

   TITLE XXIX--ENVIRONMENTAL PROTECTION AGENCY; DECONTAMINATION AND 
                              REMEDIATION

SEC. 2901. FINDINGS.

    Congress finds the following:
            (1) Nuclear, biological, and chemical decontamination 
        present different challenges for homeland security. Nuclear 
        contamination can be detected easily but can only be remediated 
        by removal of radioactive material.
            (2) Chemical contamination is relatively easy to detect, 
        dissipates rapidly in warm weather, and inactivates under the 
        right circumstances.
            (3) Biological contamination presents the biggest 
        challenge, in part, because very large indoor and outdoor areas 
        may become contaminated (hundreds of square miles) and, in 
        part, because detection methods and decontamination 
        technologies are not optimally effective.
            (4) Indoor biological decontamination can be more 
        challenging than outdoor decontamination due to the absence of 
        weathering processes and environmental decay.
            (5) Current indoor biological decontamination methods have 
        emerged from ad hoc emergency responses to the Fall 2001 
        anthrax letter attacks.
            (6) Opening one letter containing several grams of Bacillus 
        anthracis spores in the Daschle Suite of the Hart Senate Office 
        Building initiated a 3-month remediation and restoration effort 
        that ultimately involved 26 Federal buildings at a cost of 
        approximately $26,000,000.
            (7) The transit of several other anthrax-laden letters 
        through the Brentwood and Trenton United States Postal Service 
        Processing and Distribution Centers led to an unprecedented 3 
        and \1/2\ year remediation effort involving tens of thousands 
        of environmental samples and on-site construction of 
        specialized chlorine dioxide decontamination facilities at a 
        total cost of more than $200,000,000.
            (8) It is not practical to scale up these operations to 
        handle 1 or more wide-area anthrax releases.

SEC. 2902. REPORT ON CAPABILITIES.

    (a) In General.--Not later than one year after the date of 
enactment of this Act, the Administrator of the Environmental 
Protection Agency (referred to in this section as the 
``Administrator''), in consultation with the Secretary of Defense, the 
Secretary of Health and Human Services, the Secretary of Homeland 
Security, and other Federal agencies as determined appropriated by the 
Administrator, shall submit to the Committees on Health, Education, 
Labor, and Pensions, Armed Services, Homeland Security and Governmental 
Affairs, and Environment and Public Works of the Senate and the 
Committees on Energy and Commerce, Armed Services, Homeland Security, 
and Resources of the House of Representatives, a report that--
            (1) describes--
                    (A) the state of technology for the detection and 
                monitoring of nuclear, biological, and chemical 
                contamination;
                    (B) the technologies and operational concepts for 
                indoor and outdoor environmental remediation of such 
                contamination;
                    (C) training and doctrine for decontamination;
                    (D) the safety and environmental consequences 
                associated with such remediation and decontamination 
                procedures;
                    (E) the financial costs and timelines associated 
                with such procedures;
                    (F) the number of available decontamination 
                companies and personnel, along with plans for 
                augmenting such workforce in an emergency;
                    (G) the health and safety standards used to 
                determine efficacy of clean up procedures, and the 
                state of efforts to define such standards;
                    (H) an assessment of Federal assets to coordinate 
                and implement decontamination responses; and
                    (I) the ability of the Environmental Protection 
                Agency and other agencies to train, equip, and field a 
                dedicated homeland defense decontamination capability; 
                and
            (2) makes recommendations with respect to--
                    (A) defining different contamination events and 
                scenarios;
                    (B) research, technologies, and technology 
                infrastructure, needed to fill technology deficiencies;
                    (C) development of doctrine, training, and 
                certification methods for decontamination;
                    (D) methods of enhancing the Federal, as well as 
                industrial, response capability;
                    (E) dual use technologies and programs;
                    (F) methods for coordination among the Department 
                of Defense, the Department of Health and Human 
                Services, the Technology Safety Working Group of the 
                United States Army, the Defense Advanced Research 
                Projects Agency, and the Defense Threat Reduction 
                Agency;
                    (G) development of standards for decontamination 
                (both health and environmental); and
                    (H) a joint decontamination research, development, 
                and operational program.
    (b) Request by Administrator.--
            (1) In general.--The Administrator may request that the 
        Secretary of Health and Human Services enter into an 
        interagency agreement, under terms acceptable to the Secretary, 
        in which the Environmental Protection Agency may order 
        countermeasures under procurement contracts or procurement 
        pools established by the Secretary.
            (2) Processing of orders.--The ordering of a countermeasure 
        under an agreement under paragraph (1) (including transfers of 
        appropriated funds between the Environmental Protection Agency 
        and the Department of Health and Human Services to pay for such 
        order) may be conducted pursuant to section 1535 of title 31, 
        United States Code, if such order is processed under the terms 
        established--
                    (A) by the Secretary of Health and Human Services 
                in the interagency agreement described under paragraph 
                (1); and
                    (B) in the Project BioShield Act of 2004 and this 
                Act (and the amendments made by such Acts) with respect 
                to the procurement of countermeasures under sections 
                319F-1 and 319F-2 of the Public Health Service Act (42 
                U.S.C. 247d-6a and 247d-6b) (as amended by this Act).
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