[House Report 109-686]
[From the U.S. Government Publishing Office]



109th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     109-686

======================================================================



 
    BIODEFENSE AND PANDEMIC VACCINE AND DRUG DEVELOPMENT ACT OF 2006

                                _______
                                

 September 26, 2006.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

    Mr. Barton of Texas, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                        [To accompany H.R. 5533]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 5533) to prepare and strengthen the biodefenses 
of the United States against deliberate, accidental, and 
natural outbreaks of illness, and for other purposes, having 
considered the same, report favorably thereon with an amendment 
and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................     8
Background and Need for Legislation..............................     8
Hearings.........................................................     9
Committee Consideration..........................................     9
Committee Votes..................................................     9
Committee Oversight Findings.....................................     9
Statement of General Performance Goals and Objectives............     9
New Budget Authority, Entitlement Authority, and Tax Expenditures     9
Earmark..........................................................    10
Committee Cost Estimate..........................................    10
Congressional Budget Office Estimate.............................    10
Federal Mandates Statement.......................................    12
Advisory Committee Statement.....................................    12
Constitutional Authority Statement...............................    12
Applicability to Legislative Branch..............................    12
Section-by-Section Analysis of the Legislation...................    13
Changes in Existing Law Made by the Bill, as Reported............    14

                               Amendment

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Biodefense and Pandemic Vaccine and 
Drug Development Act of 2006''.

SEC. 2. TABLE OF CONTENTS.

  The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Biomedical Advanced Research and Development Authority; 
National Biodefense Science Board.
Sec. 4. Clarification of countermeasures covered by Project BioShield.
Sec. 5. Technical assistance.
Sec. 6. Procurement.

SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY; 
                    NATIONAL BIODEFENSE SCIENCE BOARD.

  Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is 
amended by inserting after section 319K the following:

``SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.

  ``(a) Biomedical Advanced Research and Development Authority.--
          ``(1) Establishment.--There is established within the 
        Department of Health and Human Services the Biomedical Advanced 
        Research and Development Authority.
          ``(2) In general.--The Secretary shall coordinate and oversee 
        the acceleration of countermeasure and product advanced 
        research and development by--
                  ``(A) facilitating collaboration among the Department 
                of Health and Human Services, other Federal agencies, 
                relevant industries, academia, and other persons, with 
                respect to such advanced research and development;
                  ``(B) promoting countermeasure and product advanced 
                research and development;
                  ``(C) facilitating contacts between interested 
                persons and the offices or employees authorized by the 
                Secretary to advise such persons regarding requirements 
                under the Federal Food, Drug, and Cosmetic Act and 
                under section 351 of this Act; and
                  ``(D) promoting innovation to reduce the time and 
                cost of countermeasure and product advanced research 
                and development.
          ``(3) Director.--The BARDA shall be headed by a Director 
        (referred to in this section as the `Director') who shall be 
        appointed by the Secretary and to whom the Secretary shall 
        delegate such functions and authorities as necessary to 
        implement this section.
          ``(4) Duties.--
                  ``(A) Collaboration.--To carry out the purpose 
                described in paragraph (2)(A), the Secretary shall--
                          ``(i) facilitate and increase the expeditious 
                        and direct communication between the Department 
                        of Health and Human Services and relevant 
                        persons with respect to countermeasure and 
                        product advanced research and development, 
                        including by--
                                  ``(I) facilitating such communication 
                                regarding the processes for procuring 
                                such advanced research and development 
                                with respect to qualified 
                                countermeasures and qualified pandemic 
                                or epidemic products of interest; and
                                  ``(II) soliciting information about 
                                and data from research on potential 
                                qualified countermeasures and qualified 
                                pandemic or epidemic products and 
                                related technologies;
                          ``(ii) at least annually--
                                  ``(I) convene meetings with 
                                representatives from relevant 
                                industries, academia, other Federal 
                                agencies, international agencies as 
                                appropriate, and other interested 
                                persons;
                                  ``(II) sponsor opportunities to 
                                demonstrate the operation and 
                                effectiveness of relevant biodefense 
                                countermeasure technologies; and
                                  ``(III) convene such working groups 
                                on countermeasure and product advanced 
                                research and development as the 
                                Secretary may determine are necessary 
                                to carry out this section; and
                          ``(iii) carry out the activities described in 
                        section 6 of the Biodefense and Pandemic 
                        Vaccine and Drug Development Act of 2006.
                  ``(B) Support advanced research and development.--To 
                carry out the purpose described in paragraph (2)(B), 
                the Secretary shall--
                          ``(i) conduct ongoing searches for, and 
                        support calls for, potential qualified 
                        countermeasures and qualified pandemic or 
                        epidemic products;
                          ``(ii) direct and coordinate the 
                        countermeasure and product advanced research 
                        and development activities of the Department of 
                        Health and Human Services;
                          ``(iii) establish strategic initiatives to 
                        accelerate countermeasure and product advanced 
                        research and development and innovation in such 
                        areas as the Secretary may identify as priority 
                        unmet need areas; and
                          ``(iv) award contracts, grants, cooperative 
                        agreements, and enter into other transactions, 
                        for countermeasure and product advanced 
                        research and development.
                  ``(C) Facilitating advice.--To carry out the purpose 
                described in paragraph (2)(C) the Secretary shall--
                          ``(i) connect interested persons with the 
                        offices or employees authorized by the 
                        Secretary to advise such persons regarding the 
                        regulatory requirements under the Federal Food, 
                        Drug, and Cosmetic Act and under section 351 of 
                        this Act related to the approval, clearance, or 
                        licensure of qualified countermeasures or 
                        qualified pandemic or epidemic products; and
                          ``(ii) ensure that, with respect to persons 
                        performing countermeasure and product advanced 
                        research and development funded under this 
                        section, such offices or employees provide such 
                        advice in a manner that is ongoing and that is 
                        otherwise designated to facilitate expeditious 
                        development of qualified countermeasures and 
                        qualified pandemic or epidemic products that 
                        may achieve such approval, clearance, or 
                        licensure.
                  ``(D) Supporting innovation.--To carry out the 
                purpose described in paragraph (2)(D), the Secretary 
                may award contracts, grants, and cooperative 
                agreements, or enter into other transactions, such as 
                prize payments, to promote--
                          ``(i) innovation in technologies that may 
                        assist countermeasure and product advanced 
                        research and development;
                          ``(ii) research on and development of 
                        research tools and other devices and 
                        technologies; and
                          ``(iii) research to promote strategic 
                        initiatives, such as rapid diagnostics, broad 
                        spectrum antimicrobials, and vaccine 
                        manufacturing technologies.
          ``(5) Transaction authorities.--
                  ``(A) Other transactions.--In carrying out the 
                functions under subparagraph (B) or (D) of paragraph 
                (4), the Secretary shall have authority to enter into 
                other transactions for countermeasure and product 
                advanced research and development.
                  ``(B) Expedited authorities.--
                          ``(i) In general.--In awarding contracts, 
                        grants, and cooperative agreements, and in 
                        entering into other transactions under 
                        subparagraph (B) or (D) of paragraph (4), the 
                        Secretary shall have the expedited procurement 
                        authorities, the authority to expedite peer 
                        review, and the authority for personal services 
                        contracts, supplied by subsections (b), (c), 
                        and (d) of section 319F-1.
                          ``(ii) Application of provisions.--Provisions 
                        in such section 319F-1 that apply to such 
                        authorities and that require institution of 
                        internal controls, limit review, provide for 
                        Federal Tort Claims Act coverage of personal 
                        services contractors, and commit decisions to 
                        the discretion of the Secretary shall apply to 
                        the authorities as exercised pursuant to this 
                        paragraph.
                          ``(iii) Authority to limit competition.--For 
                        purposes of applying section 319F-1(b)(1)(D) to 
                        this paragraph, the phrase `BioShield Program 
                        under the Project BioShield Act of 2004' shall 
                        be deemed to mean the countermeasure and 
                        product advanced research and development 
                        program under this section.
                          ``(iv) Availability of data.--The Secretary 
                        may require that, as a condition of being 
                        awarded a contract, grant, cooperative 
                        agreement, or other transaction under 
                        subparagraph (B) or (D) of paragraph (4), a 
                        person make available to the Secretary on an 
                        ongoing basis, and submit upon request to the 
                        Secretary, relevant data related to or 
                        resulting from countermeasure and product 
                        advanced research and development carried out 
                        pursuant to this section.
                  ``(C) Advance payments; advertising.--The authority 
                of the Secretary to enter into contracts under this 
                section shall not be limited by section 3324(a) of 
                title 31, United States Code, or by section 3709 of the 
                Revised Statutes of the United States (41 U.S.C. 5).
                  ``(D) Milestone-based payments allowed.--In awarding 
                contracts, grants, and cooperative agreements, and in 
                entering into other transactions, under this section, 
                the Secretary may use milestone-based awards and 
                payments.
                  ``(E) Foreign nationals eligible.--The Secretary may 
                under this section award contracts, grants, and 
                cooperative agreements to, and may enter into other 
                transactions with, highly qualified foreign national 
                persons outside the United States, alone or in 
                collaboration with American participants, when such 
                transactions may inure to the benefit of the American 
                people and are consistent with National security.
                  ``(F) Establishment of advanced research centers.--
                The Secretary may establish one or more federally-
                funded research and development centers, or university-
                affiliated research centers in accordance with section 
                303(c)(3) of the Federal Property and Administrative 
                Services Act of 1949 (41 U.S.C. 253(c)(3)), provided 
                that such centers are consistent and complementary with 
                the duties described in paragraph (4), and are 
                consistent and complementary with, and deemed necessary 
                after considering the availability of, existing 
                federally-supported basic research programs.
          ``(6) Vulnerable populations.--In carrying out the functions 
        under this section, the Secretary may give priority to the 
        advanced research and development of qualified countermeasures 
        and qualified pandemic or epidemic products that are likely to 
        be safe and effective with respect to the emergency health 
        security needs of children and other vulnerable populations.
          ``(7) Personnel authorities.--
                  ``(A) Specially qualified scientific and professional 
                personnel.--In addition to any other personnel 
                authorities, the Secretary may--
                          ``(i) without regard to those provisions of 
                        title 5, United States Code, governing 
                        appointments in the competitive service, 
                        appoint highly qualified individuals to 
                        scientific or professional positions in BARDA, 
                        such as program managers, to carry out this 
                        section; and
                          ``(ii) compensate them in the same manner in 
                        which individuals appointed under section 9903 
                        of such title are compensated, without regard 
                        to the provisions of chapter 51 and subchapter 
                        III of chapter 53 of such title relating to 
                        classification and General Schedule pay rates.
                  ``(B) Special consultants.--In carrying out this 
                section, the Secretary may--
                          ``(i) appoint special consultants pursuant to 
                        section 207(f); and
                          ``(ii) accept voluntary and uncompensated 
                        services.
  ``(c) Inapplicability of Certain Provisions.--
          ``(1) Disclosure.--
                  ``(A) In general.--The Secretary shall withhold from 
                disclosure under section 552 of title 5, United States 
                Code, specific technical data or scientific information 
                that is created or obtained during the countermeasure 
                and product advanced research and development funded by 
                the Secretary that reveal vulnerabilities of existing 
                medical or public health defenses against biological, 
                chemical, nuclear, or radiological threats. Such 
                information shall be deemed to be information described 
                in section 552(b)(3) of title 5, United States Code.
                  ``(B) Oversight.--Information subject to 
                nondisclosure under subparagraph (A) shall be reviewed 
                by the Secretary every 5 years to determine the 
                relevance or necessity of continued nondisclosure.
          ``(2) Federal advisory committee act.--Section 14 of the 
        Federal Advisory Committee Act (5 U.S.C. App.) shall not apply 
        to a working group of BARDA or to the National Biodefense 
        Science Board under section 319M.
  ``(d) Authorization of Appropriations.--For the purpose of carrying 
out advanced research and development under this section, there are 
authorized to be appropriated $160,000,000 for each of the fiscal years 
2007 and 2008. Such authorizations are in addition to other 
authorizations of appropriations that are available for such purpose. 
Amounts appropriated under the preceding sentence are available until 
expended.
  ``(e) Definitions.--For purposes of this section:
          ``(1) BARDA.--The term `BARDA' means the Biomedical Advanced 
        Research and Development Authority.
          ``(2) Other transactions.--The term `other transactions' 
        means transactions, other than procurement contracts, grants, 
        and cooperative agreements, such as the Secretary of Defense 
        may enter into under section 2371 of title 10, United States 
        Code.
          ``(3) Qualified countermeasure.--The term `qualified 
        countermeasure' has the meaning given such term in section 
        319F-1.
          ``(4) Qualified pandemic or epidemic product.--The term 
        `qualified pandemic or epidemic product' has the meaning given 
        the term in section 319F-3.
          ``(5) Advanced research and development.--
                  ``(A) In general.--The term `advanced research and 
                development' means, with respect to a product that is 
                or may become a qualified countermeasure or a qualified 
                pandemic or epidemic product, activities that 
                predominantly--
                          ``(i) are conducted after basic research and 
                        preclinical development of the product; and
                          ``(ii) are related to manufacturing the 
                        product on a commercial scale and in a form 
                        that satisfies the regulatory requirements 
                        under the Federal Food, Drug, and Cosmetic Act 
                        or under section 351 of this Act.
                  ``(B) Activities included.--The term under 
                subparagraph (A) includes--
                          ``(i) testing of the product to determine 
                        whether the product may be approved, cleared, 
                        or licensed under the Federal Food, Drug, and 
                        Cosmetic Act or under section 351 of this Act 
                        for a use that is or may be the basis for such 
                        product becoming a qualified countermeasure or 
                        qualified pandemic or epidemic product, or to 
                        help obtain such approval, clearance, or 
                        license;
                          ``(ii) design and development of tests or 
                        models, including animal models, for such 
                        testing;
                          ``(iii) activities to facilitate manufacture 
                        of the product on a commercial scale with 
                        consistently high quality, as well as to 
                        improve and make available new technologies to 
                        increase manufacturing surge capacity;
                          ``(iv) activities to improve the shelf-life 
                        of the product or technologies for 
                        administering the product; and
                          ``(v) such other activities as are part of 
                        the advanced stages of testing, refinement, 
                        improvement, or preparation of the product for 
                        such use and as are specified by the Secretary.
          ``(6) Research tool.--The term `research tool' means a 
        device, technology, biological material, reagent, animal model, 
        computer system, computer software, or analytical technique 
        that is developed to assist in the discovery, development, or 
        manufacture of qualified countermeasures or qualified pandemic 
        or epidemic products.
          ``(7) Program manager.--The term `program manager' means an 
        individual appointed to carry out functions under this section 
        and authorized to provide project oversight and management of 
        strategic initiatives.
          ``(8) Person.--The term `person' includes an individual, 
        partnership, corporation, association, entity, or public or 
        private corporation, and a Federal, State, or local government 
        agency or department.

``SEC. 319M. NATIONAL BIODEFENSE SCIENCE BOARD AND WORKING GROUPS.

  ``(a) In General.--
          ``(1) Establishment and function.--The Secretary shall 
        establish the National Biodefense Science Board (referred to in 
        this section as the `Board') to provide expert advice and 
        guidance to the Secretary on scientific, technical and other 
        matters of special interest to the Department of Health and 
        Human Services regarding current and future chemical, 
        biological, nuclear, and radiological agents, whether naturally 
        occurring, accidental, or deliberate.
          ``(2) Membership.--The membership of the Board shall be 
        comprised of individuals who represent the Nation's preeminent 
        scientific, public health, and medical experts, as follows--
                  ``(A) such Federal officials as the Secretary may 
                determine are necessary to support the functions of the 
                Board;
                  ``(B) four individuals representing the 
                pharmaceutical, biotechnology, and device industries;
                  ``(C) four individuals representing academia; and
                  ``(D) five other members as determined appropriate by 
                the Secretary.
          ``(3) Term of appointment.--A member of the Board described 
        in subparagraph (B), (C), or (D) of paragraph (2) shall serve 
        for a term of 3 years, except that the Secretary may adjust the 
        terms of the initial Board appointees in order to provide for a 
        staggered term of appointment for all members.
          ``(4) Consecutive appointments; maximum terms.--A member may 
        be appointed to serve not more than 3 terms on the Board and 
        may serve not more than 2 consecutive terms.
          ``(5) Duties.--The Board shall--
                  ``(A) advise the Secretary on current and future 
                trends, challenges, and opportunities presented by 
                advances in biological and life sciences, 
                biotechnology, and genetic engineering with respect to 
                threats to biodefense or public health security posed 
                by naturally occurring infectious diseases and 
                chemical, biological, radiological, and nuclear agents;
                  ``(B) at the request of the Secretary, review and 
                consider any information and findings received from the 
                working groups established under subsection (b); and
                  ``(C) at the request of the Secretary, provide 
                recommendations and findings for expanded, intensified, 
                and coordinated biodefense research and development 
                activities.
          ``(6) Meetings.--
                  ``(A) Initial meeting.--Not later than one year after 
                the date of enactment of the Biodefense and Pandemic 
                Vaccine and Drug Development Act of 2006, the Secretary 
                shall hold the first meeting of the Board.
                  ``(B) Subsequent meetings.--The Board shall meet at 
                the call of the Secretary, but in no case less than 
                twice annually.
          ``(7) Vacancies.--Any vacancy in the Board shall not affect 
        its powers, but shall be filled in the same manner as the 
        original appointment.
          ``(8) Chairperson.--The Secretary shall appoint a chairperson 
        from among the members of the Board.
          ``(9) Powers.--
                  ``(A) Hearings.--The Board may hold such hearings, 
                sit and act at such times and places, take such 
                testimony, and receive such evidence as the Board 
                considers advisable to carry out this subsection.
                  ``(B) Postal services.--The Board may use the United 
                States mails in the same manner and under the same 
                conditions as other departments and agencies of the 
                Federal Government.
          ``(10) Personnel.--
                  ``(A) Employees of the federal government.--A member 
                of the Board that is an employee of the Federal 
                Government may not receive additional pay, allowances, 
                or benefits by reason of the member's service on the 
                Board.
                  ``(B) Other members.--A member of the Board that is 
                not an employee of the Federal Government may be 
                compensated at a rate not to exceed the daily 
                equivalent of the annual rate of basic pay prescribed 
                for level IV of the Executive Schedule under section 
                5315 of title 5, United States Code, for each day 
                (including travel time) during which the member is 
                engaged in the actual performance of duties as a member 
                of the Board.
                  ``(C) Travel expenses.--Each member of the Board 
                shall receive travel expenses, including per diem in 
                lieu of subsistence, in accordance with applicable 
                provisions under subchapter I of chapter 57 of title 5, 
                United States Code.
                  ``(D) Detail of government employees.--Any Federal 
                Government employee may be detailed to the Board with 
                the approval for the contributing agency without 
                reimbursement, and such detail shall be without 
                interruption or loss of civil service status or 
                privilege.
  ``(b) Definitions.--Any term that is defined in section 319L and that 
is used in this section shall have the same meaning in this section as 
such term is given in section 319L.
  ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated $1,000,000 to carry out this section for each of the 
fiscal years 2007 and 2008.''.

SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED BY PROJECT BIOSHIELD.

  (a) Qualified Countermeasures.--Section 319F-1(a)(2) of the Public 
Health Service Act (42 U.S.C. 247d-6a(a)(2)) is amended--
          (1) by amending subparagraph (A) to read as follows:
                  ``(A) diagnose, mitigate, prevent, or treat harm from 
                any biological agent (including organisms that cause an 
                infectious disease) or toxin, or from any chemical, 
                radiological, or nuclear agent, that may cause a public 
                health emergency affecting national security; or'';
          (2) in subparagraph (B), by striking ``treat, identify, or 
        prevent harm'' and inserting ``diagnose, mitigate, prevent, or 
        treat harm''; and
          (3) by adding after and below subparagraph (B) the following:
        ``If through publication in the Federal Register the Secretary 
        makes a determination that there is credible evidence that a 
        biological agent has the potential to cause an epidemic or 
        pandemic that may constitute a public health emergency, a 
        countermeasure to such agent shall, without further 
        administrative action, be considered a qualified countermeasure 
        within the meaning of this paragraph.''.
  (b) Security Countermeasures.--Section 319F-2(c)(1)(B)(i)(I) of the 
Public Health Service Act (42 U.S.C. 247d-6b(c)(1)(B)(i)(I)) is amended 
by striking ``to treat'' the first place such term appears and all that 
follows through ``from a condition'' and inserting the following: ``to 
diagnose, mitigate, prevent, or treat harm from any biological agent 
(including organisms that cause an infectious disease) or toxin or from 
any chemical, radiological, or nuclear agent identified as a material 
threat under paragraph (2)(A)(ii), or to diagnose, mitigate, prevent, 
or treat harm from a condition''.

SEC. 5. TECHNICAL ASSISTANCE.

  Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb et seq.) is amended by adding at the end the 
following:

``SEC. 565. TECHNICAL ASSISTANCE.

  ``The Secretary, in consultation with the Commissioner of Food and 
Drugs, shall establish within the Food and Drug Administration a team 
of experts on manufacturing and regulatory activities (including 
compliance with current Good Manufacturing Practice) to provide both 
off-site and on-site technical assistance to the manufacturers of 
qualified countermeasures (as defined in section 319F-1 of the Public 
Health Service Act), security countermeasures (as defined in section 
319F-2 of such Act), or vaccines, at the request of such a manufacturer 
and at the discretion of the Secretary, if the Secretary determines 
that a shortage or potential shortage may occur in the United States in 
the supply of such vaccines or countermeasures and that the provision 
of such assistance would be beneficial in helping alleviate or avert 
such shortage.''.

SEC. 6. PROCUREMENT.

  Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) 
is amended--
          (1) in the section heading, by inserting ``AND SECURITY 
        COUNTERMEASURE PROCUREMENTS'' before the period; and
          (2) in subsection (c)--
                  (A) in the subsection heading, by striking 
                ``Biomedical'';
                  (B) in paragraph (5)(B)(i), by striking ``to meet the 
                needs of the stockpile'' and inserting ``to meet the 
                stockpile needs'';
                  (C) in paragraph (7)(B)--
                          (i) by striking the subparagraph heading and 
                        all that follows through ``Homeland Security 
                        Secretary'' and inserting the following: 
                        ``Interagency agreement; cost.--The Homeland 
                        Security Secretary''; and
                          (ii) by striking clause (ii);
                  (D) in paragraph (7)(C)(ii)--
                          (i) by amending clause (I) to read as 
                        follows:
                                  ``(I) Payment conditioned on 
                                delivery.--The contract shall provide 
                                that no payment may be made until 
                                delivery of a portion, acceptable to 
                                the Secretary, of the total number of 
                                units contracted for, except that, 
                                notwithstanding any other provision of 
                                law, the contract may provide that, if 
                                the Secretary determines (in the 
                                Secretary's discretion) that an advance 
                                payment, partial payment for 
                                significant milestones, or payment to 
                                increase manufacturing capacity is 
                                necessary to ensure success of a 
                                project, the Secretary shall pay an 
                                amount, not to exceed 10 percent of the 
                                contract amount, in advance of 
                                delivery. The Secretary shall, to the 
                                extent practicable, make the 
                                determination of advance payment at the 
                                same time as the issuance of a 
                                solicitation. The contract shall 
                                provide that such advance payment is 
                                required to be repaid if there is a 
                                failure to perform by the vendor under 
                                the contract. The contract may also 
                                provide for additional advance payments 
                                of 5 percent each for meeting the 
                                milestones specified in such contract. 
                                Provided that the specified milestones 
                                are reached, these advance payments of 
                                5 percent shall not be required to be 
                                repaid. Nothing in this subclause shall 
                                be construed as affecting the rights of 
                                vendors under provisions of law or 
                                regulation (including the Federal 
                                Acquisition Regulation) relating to the 
                                termination of contracts for the 
                                convenience of the Government.''; and
                          (ii) by adding at the end the following:
                                  ``(VII) Procurement of multiple 
                                products and technologies.--The 
                                Secretary may enter into multiple 
                                transactions for the procurement of 
                                multiple technologies and products from 
                                multiple manufacturers of security 
                                countermeasures in order to mitigate 
                                against the risks associated with 
                                dependence on a single supplier or 
                                technology.
                                  ``(VIII) Sales exclusivity.--The 
                                contract may provide that the vendor is 
                                the exclusive supplier of the product 
                                to the Federal Government for a 
                                specified period of time, not to exceed 
                                the term of the contract, on the 
                                condition that the vendor is able to 
                                satisfy the needs of the Government. 
                                During the agreed period of sales 
                                exclusivity, the vendor shall not 
                                assign its rights of sales exclusivity 
                                to another entity or entities without 
                                approval by the Secretary. Such a sales 
                                exclusivity provision in such a 
                                contract shall constitute a valid basis 
                                for a sole source procurement under 
                                section 303(c)(1) of the Federal 
                                Property and Administrative Services 
                                Act of 1949 (41 U.S.C. 253(c)(1)).
                                  ``(IX) Surge capacity.--The contract 
                                may provide that the vendor establish 
                                domestic manufacturing capacity of the 
                                product to ensure that additional 
                                production of the product is available 
                                in the event that the Secretary 
                                determines that there is a need to 
                                quickly purchase additional quantities 
                                of the product. Such contract may 
                                provide a fee to the vendor for 
                                establishing and maintaining such 
                                capacity in excess of the initial 
                                requirement for the purchase of the 
                                product. Additionally, the cost of 
                                maintaining the domestic manufacturing 
                                capacity shall be an allowable and 
                                allocable direct cost of the contract.
                                  ``(X) Additional contract terms.--The 
                                Secretary, in any contract for 
                                procurement under this section, may 
                                specify--
                                          ``(aa) the dosing and 
                                        administration requirements for 
                                        countermeasures to be developed 
                                        and procured;
                                          ``(bb) the amount of funding 
                                        that will be dedicated by the 
                                        Secretary for development and 
                                        acquisition of the 
                                        countermeasure; and
                                          ``(cc) the specifications the 
                                        countermeasure must meet to 
                                        qualify for procurement under a 
                                        contract under this section.''; 
                                        and
                  (E) in paragraph (8)(A), by adding at the end the 
                following: ``In the case of such agreements by the 
                Secretary, the Secretary may allow other executive 
                agencies to order qualified and security 
                countermeasures under procurement contracts or other 
                agreements established by the Secretary, and such 
                ordering process (including transfers of appropriated 
                funds between an agency and the Department of Health 
                and Human Services as reimbursements for such orders 
                for countermeasures) may be conducted under the 
                authority of section 1535 of title 31, United States 
                Code, except that all such orders shall be processed 
                under the terms established under this section for the 
                procurement of countermeasures.''

                          Purpose and Summary

    The purpose of H.R. 5533, the Biodefense and Pandemic 
Vaccine and Drug Development Act of 2006, is to prepare and 
strengthen the biodefenses of the United States against 
deliberate, accidental, and natural outbreaks of illness, and 
for other purposes.

                  Background and Need for Legislation

    Project BioShield was signed into law on July 21, 2004, to 
encourage the development of countermeasures to address 
chemical, biological, radiological, and nuclear threats. The 
legislation provided procedures for bioterrorism-related 
procurement, hiring, and awarding of research grants, in an 
effort to make it easier for the Federal government to quickly 
commit substantial funds to countermeasure projects. Congress 
has identified a number of improvements to fully realize 
Project BioShield's potential and to provide further incentives 
toward such development. H.R. 5533 provides a single point of 
authority within the Department of Health and Human Services 
for the advanced research and development of medical 
countermeasures to make important procurement decisions. The 
legislation provides needed authorization to fund advanced 
research and development activities that were not covered by 
Project Bioshield. Additionally, the legislation will provide 
for further purchasing and contractual flexibility.

                                Hearings

    On Thursday, April 6, 2006, the Subcommittee on Health held 
a hearing entitled ``Project Bioshield Reauthorization 
Issues.'' The Subcommittee received testimony from: The 
Honorable Alex M. Azar, Deputy Secretary, U.S. Department of 
Health and Human Services; Mr. Jean D. Reed, Special Assistant, 
Chemical and Biological Defense and Chemical Demilitarization 
Programs, Office of the Assistant to the Secretary of Defense 
for Nuclear and Chemical and Biological Defense, U.S. 
Department of Defense; Dr. Tara O'Toole, CEO and Director, 
Center for Biosecurity, University of Pittsburgh Medical 
Center; Mr. Peter F. Young, President and CEO, AlphaVax, Inc, 
on behalf of the Biotechnology Industry Organization; Mr. Bruce 
Cohen, President and CEO, Cellerant Therapeutics, Inc.; Dr. 
David P. Wright, President and CEO, PharmAthene, on behalf of 
the Alliance for Biosecurity; and Dr. Martin Blaser, President, 
Infectious Diseases Society of America.

                        Committee Consideration

    On Wednesday, September 20, 2006, the Committee on Energy 
and Commerce met in open markup session and ordered H.R. 5533 
favorably reported to the House, amended, by a voice vote, a 
quorum being present.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 5533 reported. A motion by Mr. Barton to order H.R. 5533 
reported to the House, amended, was agreed to by a voice vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee held an oversight 
hearing and made findings that are reflected in this report.

         Statement of General Performance Goals and Objectives

    The goal of H.R. 5533 is to prepare and strengthen the 
biodefenses of the United States against deliberate, 
accidental, and natural outbreaks of illness.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
5533, Biodefense and Pandemic Vaccine and Drug Development Act 
of 2006, would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

                                Earmark

    In compliance with H. Res. 1000 as passed the House of 
Representatives on September 14, 2006, the Committee finds that 
H.R. 5533, Biodefense and Pandemic Vaccine and Drug Development 
Act of 2006, contains no earmarks.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                                September 26, 2006.
Hon. Joe Barton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 5533, the 
Biodefense and Pandemic Vaccine and Drug Development Act of 
2006.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Jeanne De 
Sa and Sam Papenfuss.
            Sincerely,
                                          Donald B. Marron,
                                                   Acting Director.
    Enclosure.

H.R. 5533--Biodefense and Pandemic Vaccine and Drug Development Act of 
        2006

    Summary: H.R. 5533 would create an office at the Department 
of Health and Human Services (HHS) called the Biomedical 
Advanced Research and Development Authority (BARDA). BARDA 
would oversee advanced research and development of products to 
defend against bioterrorism and pandemic influenza. The bill 
also would establish the National Biodefense Science Board, an 
advisory group that would provide scientific guidance to HHS on 
issues involving chemical, biological, radiological, and 
nuclear agents. Additionally, the bill would require HHS to 
establish a team of experts at the Food and Drug Administration 
(FDA) to provide technical assistance to drug manufacturers 
when shortages of certain vaccines and drugs occur. H.R. 5533 
also would clarify that Project BioShield, a program that 
provides incentives to companies to manufacture vaccines and 
drugs, covers certain products--so-called qualified and 
security countermeasures--that address public health threats 
caused by acts of terrorism.
    The bill would authorize the appropriation of $160 million 
for each of fiscal years 2007 and 2008 for activities related 
to the operation of BARDA. The bill also would authorize the 
appropriation of $1 million for each of fiscal years 2007 and 
2008 for the National Biodefense Science Board. CBO estimates 
that $1 million a year would be necessary for FDA to implement 
activities outlined in the bill. Assuming appropriation of the 
authorized and necessary amounts, CBO estimates that 
implementing H.R. 5533 would cost $33 million in 2007 and $319 
million over the 2007-2011 period. Enacting the bill would not 
affect direct spending or receipts.
    H.R 5533 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA) 
and would impose no costs on state, local, or tribal 
governments.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 5533 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

------------------------------------------------------------------------
                                      By fiscal year, in millions of
                                                 dollars--
                                 ---------------------------------------
                                   2007    2008    2009    2010    2011
------------------------------------------------------------------------
              CHANGES IN SPENDING SUBJECT TO APPROPRIATION

BARDA:
    Authorization Level.........     160     160       0       0       0
    Estimated Outlays...........      31     148     101      24       8
National Biodefense Science
 Board:
    Authorization Level.........       1       1       0       0       0
    Estimated Outlays...........       1       1       0       0       0
FDA:
    Estimated Authorization            1       1       1       1       1
     Level......................
    Estimated Outlays...........       1       1       1       1       1
        Total Changes:
            Estimated                162     162       1       1       1
             Authorization Level
            Estimated Outlays...      33     150     102      25       9
------------------------------------------------------------------------

    Basis of estimate: For this estimate, CBO assumes that H.R. 
5533 will be enacted before the end of calendar year 2006, and 
that the authorized and necessary amounts will be provided each 
year.

Biomedical Advanced Research and Development Authority (BARDA)

    H.R. 5533 would establish BARDA as a new agency within HHS. 
BARDA would provide incentives and guidance for research and 
development of products to counter bioterrorism and pandemic 
influenza. The bill would authorize the appropriation of $160 
million for each of fiscal years 2007 and 2008 for activities 
to be performed by this new agency. Those activities would 
include facilitating collaboration among government, private 
industry, and academia; encouraging advanced research and 
development of those products; and promoting scientific 
innovation to reduce the time and cost of development. 
Specifically, BARDA would direct and coordinate research and 
development activities for countermeasures to bioterrorism and 
pandemic influenza at HHS. The agency also would offer grants, 
awards, and prizes to industry to provide incentives to develop 
certain countermeasures deemed priorities.
    For this estimate, CBO assumes that spending by BARDA would 
follow historical spending patterns for similar research and 
development activities in health care and defense programs. 
Assuming appropriation of the authorized amounts, CBO estimates 
that BARDA spending would total $31 million in 2007 and $312 
million over the 2007-2011 period.

National Biodefense Science Board

    The bill would authorize the appropriation of $1 million 
for each of fiscal years 2007 and 2008 to establish the 
National Biodefense Science Board, an advisory group that would 
provide scientific and technical guidance to HHS on current and 
future chemical, biological, radiological, and nuclear agents. 
Assuming appropriation of the authorized amounts, CBO estimates 
that provision would cost $2 million over the 2007-2008 period.

Food and Drug Administration (FDA)

    H.R. 5533 would require the FDA to provide technical 
assistance to drug manufacturers in cases where there are 
shortages of certain vaccines and drugs that the Secretary 
deems priorities for addressing a public health threat. Based 
on similar technical-advisory activities conducted by HHS, CBO 
estimates that the program would require funding of about $1 
million a year. CBO estimates that this provision of the bill 
would cost $1 million in 2007 and $5 million over the 2007-2011 
period, assuming appropriation of the necessary amounts.
    Intergovernmental and private-sector impact: H.R. 5533 
contains no intergovernmental or private-sector mandates as 
defined in UMRA and would impose no costs on state, local, or 
tribal governments.
    Estimate prepared by: Federal Costs: Jeanne De Sa and Sam 
Papenfuss. Impact on State, Local, and Tribal Governments: Leo 
Lex. Impact on the Private Sector: Paige Shevlin.
    Estimate approved by: Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 establishes the short title as the Biodefense and 
Pandemic Vaccine and Drug Development Act of 2006.

Section 2. Table of contents

    Section 2 sets out the table of contents for the Act.

Section 3. Biomedical Advanced Research and Development Authority; 
        National Biodefense Science Board

    Section 3 amends Title III of the Public Health Service Act 
by adding a new Section 319L and new Section 319M.
            ``Section 319L. Biomedical Advanced Research and 
                    Development Authority.''
    New Section 319L in Title III of the Public Health Service 
Act would set out a Biomedical Advanced Research and 
Development Authority. Many of the functions and duties set out 
in this section currently exist at the Department under prior 
authorizations and decisions of the Secretary. This provision 
reorganizes and expands upon these existing authorities and 
duties. Among other items, new section 319L will establish a 
single point of authority in the Federal government for 
civilian medical countermeasure advanced research and 
development, direct and coordinate advanced research and 
development of promising new medical countermeasures; and spur 
innovation to accelerate countermeasure development. The 
exception builds on the efforts authorized under the Project 
Bioshield Act of 2003. The additional authorities will address 
the development area beyond research and before manufacturing.
    The activities intended for inclusion under the definition 
of ``advanced research and development'' include the broad 
array of activities that are predominantly conducted after 
basic research and are conducted to enable the efficient 
development, testing, manufacture, storage, or use of a product 
that is or may become a qualified countermeasure or a qualified 
pandemic or epidemic product. These include the duties of BARDA 
described in new Section 319L(a)(2)(B) and (a)(4)(D).
    New Section 319L would also exempt the Secretary from 
requirements under the Freedom of Information Act in order to 
withhold from forced disclosure of specific technical data or 
scientific information that would reveal vulnerabilities of 
existing medical or public health defenses against biological, 
chemical, nuclear, or radiological threats.
    New Section 319L also provides for authorizations of $160 
million for FY 2007 and $160 million FY 2008 for advanced 
research and development activities.
            ``Section 319M. National Biodefense Science Board and 
                    Working Groups.''
    New section 319M provides for the Public Health Service Act 
which establishes a National Biodefense Science Board.

Section 4. Clarification of countermeasures covered by Project 
        BioShield

    Section 4 clarifies the definition of qualified 
countermeasures under Project BioShield to include organisms 
that might cause infectious disease that may cause a public 
health emergency affecting national security.

Section 5. Technical assistance

    Section 5 amends subchapter E of chapter V of the Federal 
Food, Drug, and Cosmetic Act by adding a new Section 565.
            ``Section 565. Technical Assistance.''
    New Section 565 provides for the Secretary, in consultation 
with the Commissioner of Food and Drugs, to establish a team to 
work with manufacturers to identify and resolve problems to 
alleviate or avert significant shortage of a vaccine or 
countermeasure.

Section 6. Procurement

    Section 6 provides authority to allow the Secretary, under 
certain circumstances, to enter into an exclusive sales 
contract with a particular manufacturer for a particular 
product, but also allows for procurement of technologies and 
products from multiple manufacturers. The section provides 
authority to allow contracts to support the cost of 
establishing domestic manufacturing capacity; and to include 
additional advance payments for meeting specified milestones. 
The section further allows other executive agencies to order 
countermeasures through the Department of Health and Human 
Services.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *



     TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE


Part B--Federal-State Cooperation

           *       *       *       *       *       *       *



SEC. 319F-1. AUTHORITY FOR USE OF CERTAIN PROCEDURES REGARDING 
                    QUALIFIED COUNTERMEASURE RESEARCH AND DEVELOPMENT 
                    ACTIVITIES. 

  (a) In General.--
          (1) * * *

           *       *       *       *       *       *       *

          (2) Qualified countermeasure.--For purposes of this 
        section, the term ``qualified countermeasure'' means a 
        drug (as that term is defined by section 201(g)(1) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        321(g)(1))), biological product (as that term is 
        defined by section 351(i) of this Act (42 U.S.C. 
        262(i))), or device (as that term is defined by section 
        201(h) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321(h))) that the Secretary determines to be a 
        priority (consistent with sections 302(2) and 304(a) of 
        the Homeland Security Act of 2002) to--
                  [(A) treat, identify, or prevent harm from 
                any biological, chemical, radiological, or 
                nuclear agent that may cause a public health 
                emergency affecting national security; or]
                  (A) diagnose, mitigate, prevent, or treat 
                harm from any biological agent (including 
                organisms that cause an infectious disease) or 
                toxin, or from any chemical, radiological, or 
                nuclear agent, that may cause a public health 
                emergency affecting national security; or
                  (B) [treat, identify, or prevent harm] 
                diagnose, mitigate, prevent, or treat harm from 
                a condition that may result in adverse health 
                consequences or death and may be caused by 
                administering a drug, biological product, or 
                device that is used as described in 
                subparagraph (A).
        If through publication in the Federal Register the 
        Secretary makes a determination that there is credible 
        evidence that a biological agent has the potential to 
        cause an epidemic or pandemic that may constitute a 
        public health emergency, a countermeasure to such agent 
        shall, without further administrative action, be 
        considered a qualified countermeasure within the 
        meaning of this paragraph.

           *       *       *       *       *       *       *


SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE AND SECURITY COUNTERMEASURE 
                    PROCUREMENTS.

  (a) * * *

           *       *       *       *       *       *       *

  (c) Additional Authority Regarding Procurement of Certain 
[Biomedical] Countermeasures; Availability of Special Reserve 
Fund.--
          (1) In general.--
                  (A) * * *
                  (B) Security countermeasure.--For purposes of 
                this subsection, the term ``security 
                countermeasure'' means a drug (as that term is 
                defined by section 201(g)(1) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 
                321(g)(1))), biological product (as that term 
                is defined by section 351(i) of this Act (42 
                U.S.C. 262(i))), or device (as that term is 
                defined by section 201(h) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 321(h))) 
                that--
                          (i)(I) the Secretary determines to be 
                        a priority (consistent with sections 
                        302(2) and 304(a) of the Homeland 
                        Security Act of 2002) [to treat, 
                        identify, or prevent harm from any 
                        biological, chemical, radiological, or 
                        nuclear agent identified as a material 
                        threat under paragraph (2)(A)(ii), or 
                        to treat, identify, or prevent harm 
                        from a condition] to diagnose, 
                        mitigate, prevent, or treat harm from 
                        any biological agent (including 
                        organisms that cause an infectious 
                        disease) or toxin or from any chemical, 
                        radiological, or nuclear agent 
                        identified as a material threat under 
                        paragraph (2)(A)(ii), or to diagnose, 
                        mitigate, prevent, or treat harm from a 
                        condition that may result in adverse 
                        health consequences or death and may be 
                        caused by administering a drug, 
                        biological product, or device against 
                        such an agent;

           *       *       *       *       *       *       *

          (5) Secretary's determination of countermeasures 
        appropriate for funding from special reserve fund.--
                  (A) * * *
                  (B) Requirements.--In making a determination 
                under subparagraph (A) with respect to a 
                security countermeasure, the Secretary shall 
                determine and consider the following:
                          (i) The quantities of the product 
                        that will be needed [to meet the needs 
                        of the stockpile] to meet the stockpile 
                        needs.

           *       *       *       *       *       *       *

          (7) Procurement.--
                  (A) * * *
                  (B) [Interagency agreement; costs.--
                          (i) Interagency agreement.--The 
                        Homeland Security Secretary] 
                        Interagency agreement; cost.--The 
                        Homeland Security Secretary shall enter 
                        into an agreement with the Secretary 
                        for procurement of a security 
                        countermeasure in accordance with the 
                        provisions of this paragraph. The 
                        special reserve fund under paragraph 
                        (10) shall be available for payments 
                        made by the Secretary to a vendor for 
                        such procurement.
                          [(ii) Other costs.--The actual costs 
                        to the Secretary under this section, 
                        other than the costs described in 
                        clause (i), shall be paid from the 
                        appropriation provided for under 
                        subsection (f)(1).]
                  (C) Procurement.--
                          (i) * * *
                          (ii) Contract terms.--A contract for 
                        procurements under this subsection 
                        shall (or, as specified below, may) 
                        include the following terms:
                                  [(I) Payment conditioned on 
                                delivery.--The contract shall 
                                provide that no payment may be 
                                made until delivery has been 
                                made of a portion, acceptable 
                                to the Secretary, of the total 
                                number of units contracted for, 
                                except that, notwithstanding 
                                any other provision of law, the 
                                contract may provide that, if 
                                the Secretary determines (in 
                                the Secretary's discretion) 
                                that an advance payment is 
                                necessary to ensure success of 
                                a project, the Secretary may 
                                pay an amount, not to exceed 10 
                                percent of the contract amount, 
                                in advance of delivery. The 
                                contract shall provide that 
                                such advance payment is 
                                required to be repaid if there 
                                is a failure to perform by the 
                                vendor under the contract. 
                                Nothing in this subclause may 
                                be construed as affecting 
                                rights of vendors under 
                                provisions of law or regulation 
                                (including the Federal 
                                Acquisition Regulation) 
                                relating to termination of 
                                contracts for the convenience 
                                of the Government.]
                                  (I) Payment conditioned on 
                                delivery.--The contract shall 
                                provide that no payment may be 
                                made until delivery of a 
                                portion, acceptable to the 
                                Secretary, of the total number 
                                of units contracted for, except 
                                that, notwithstanding any other 
                                provision of law, the contract 
                                may provide that, if the 
                                Secretary determines (in the 
                                Secretary's discretion) that an 
                                advance payment, partial 
                                payment for significant 
                                milestones, or payment to 
                                increase manufacturing capacity 
                                is necessary to ensure success 
                                of a project, the Secretary 
                                shall pay an amount, not to 
                                exceed 10 percent of the 
                                contract amount, in advance of 
                                delivery. The Secretary shall, 
                                to the extent practicable, make 
                                the determination of advance 
                                payment at the same time as the 
                                issuance of a solicitation. The 
                                contract shall provide that 
                                such advance payment is 
                                required to be repaid if there 
                                is a failure to perform by the 
                                vendor under the contract. The 
                                contract may also provide for 
                                additional advance payments of 
                                5 percent each for meeting the 
                                milestones specified in such 
                                contract. Provided that the 
                                specified milestones are 
                                reached, these advance payments 
                                of 5 percent shall not be 
                                required to be repaid. Nothing 
                                in this subclause shall be 
                                construed as affecting the 
                                rights of vendors under 
                                provisions of law or regulation 
                                (including the Federal 
                                Acquisition Regulation) 
                                relating to the termination of 
                                contracts for the convenience 
                                of the Government.

           *       *       *       *       *       *       *

                                  (VII) Procurement of multiple 
                                products and technologies.--The 
                                Secretary may enter into 
                                multiple transactions for the 
                                procurement of multiple 
                                technologies and products from 
                                multiple manufacturers of 
                                security countermeasures in 
                                order to mitigate against the 
                                risks associated with 
                                dependence on a single supplier 
                                or technology.
                                  (VIII) Sales exclusivity.--
                                The contract may provide that 
                                the vendor is the exclusive 
                                supplier of the product to the 
                                Federal Government for a 
                                specified period of time, not 
                                to exceed the term of the 
                                contract, on the condition that 
                                the vendor is able to satisfy 
                                the needs of the Government. 
                                During the agreed period of 
                                sales exclusivity, the vendor 
                                shall not assign its rights of 
                                sales exclusivity to another 
                                entity or entities without 
                                approval by the Secretary. Such 
                                a sales exclusivity provision 
                                in such a contract shall 
                                constitute a valid basis for a 
                                sole source procurement under 
                                section 303(c)(1) of the 
                                Federal Property and 
                                Administrative Services Act of 
                                1949 (41 U.S.C. 253(c)(1)).
                                  (IX) Surge capacity.--The 
                                contract may provide that the 
                                vendor establish domestic 
                                manufacturing capacity of the 
                                product to ensure that 
                                additional production of the 
                                product is available in the 
                                event that the Secretary 
                                determines that there is a need 
                                to quickly purchase additional 
                                quantities of the product. Such 
                                contract may provide a fee to 
                                the vendor for establishing and 
                                maintaining such capacity in 
                                excess of the initial 
                                requirement for the purchase of 
                                the product. Additionally, the 
                                cost of maintaining the 
                                domestic manufacturing capacity 
                                shall be an allowable and 
                                allocable direct cost of the 
                                contract.
                                  (X) Additional contract 
                                terms.--The Secretary, in any 
                                contract for procurement under 
                                this section, may specify--
                                          (aa) the dosing and 
                                        administration 
                                        requirements for 
                                        countermeasures to be 
                                        developed and procured;
                                          (bb) the amount of 
                                        funding that will be 
                                        dedicated by the 
                                        Secretary for 
                                        development and 
                                        acquisition of the 
                                        countermeasure; and
                                          (cc) the 
                                        specifications the 
                                        countermeasure must 
                                        meet to qualify for 
                                        procurement under a 
                                        contract under this 
                                        section.

           *       *       *       *       *       *       *

          (8) Interagency cooperation.--
                  (A) In general.--In carrying out activities 
                under this section, the Homeland Security 
                Secretary and the Secretary are authorized, 
                subject to subparagraph (B), to enter into 
                interagency agreements and other collaborative 
                undertakings with other agencies of the United 
                States Government. In the case of such 
                agreements by the Secretary, the Secretary may 
                allow other executive agencies to order 
                qualified and security countermeasures under 
                procurement contracts or other agreements 
                established by the Secretary, and such ordering 
                process (including transfers of appropriated 
                funds between an agency and the Department of 
                Health and Human Services as reimbursements for 
                such orders for countermeasures) may be 
                conducted under the authority of section 1535 
                of title 31, United States Code, except that 
                all such orders shall be processed under the 
                terms established under this section for the 
                procurement of countermeasures.

           *       *       *       *       *       *       *


SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.

  (a) Biomedical Advanced Research and Development Authority.--
          (1) Establishment.--There is established within the 
        Department of Health and Human Services the Biomedical 
        Advanced Research and Development Authority.
          (2) In general.--The Secretary shall coordinate and 
        oversee the acceleration of countermeasure and product 
        advanced research and development by--
                  (A) facilitating collaboration among the 
                Department of Health and Human Services, other 
                Federal agencies, relevant industries, 
                academia, and other persons, with respect to 
                such advanced research and development;
                  (B) promoting countermeasure and product 
                advanced research and development;
                  (C) facilitating contacts between interested 
                persons and the offices or employees authorized 
                by the Secretary to advise such persons 
                regarding requirements under the Federal Food, 
                Drug, and Cosmetic Act and under section 351 of 
                this Act; and
                  (D) promoting innovation to reduce the time 
                and cost of countermeasure and product advanced 
                research and development.
          (3) Director.--The BARDA shall be headed by a 
        Director (referred to in this section as the 
        ``Director'') who shall be appointed by the Secretary 
        and to whom the Secretary shall delegate such functions 
        and authorities as necessary to implement this section.
          (4) Duties.--
                  (A) Collaboration.--To carry out the purpose 
                described in paragraph (2)(A), the Secretary 
                shall--
                          (i) facilitate and increase the 
                        expeditious and direct communication 
                        between the Department of Health and 
                        Human Services and relevant persons 
                        with respect to countermeasure and 
                        product advanced research and 
                        development, including by--
                                  (I) facilitating such 
                                communication regarding the 
                                processes for procuring such 
                                advanced research and 
                                development with respect to 
                                qualified countermeasures and 
                                qualified pandemic or epidemic 
                                products of interest; and
                                  (II) soliciting information 
                                about and data from research on 
                                potential qualified 
                                countermeasures and qualified 
                                pandemic or epidemic products 
                                and related technologies;
                          (ii) at least annually--
                                  (I) convene meetings with 
                                representatives from relevant 
                                industries, academia, other 
                                Federal agencies, international 
                                agencies as appropriate, and 
                                other interested persons;
                                  (II) sponsor opportunities to 
                                demonstrate the operation and 
                                effectiveness of relevant 
                                biodefense countermeasure 
                                technologies; and
                                  (III) convene such working 
                                groups on countermeasure and 
                                product advanced research and 
                                development as the Secretary 
                                may determine are necessary to 
                                carry out this section; and
                          (iii) carry out the activities 
                        described in section 6 of the 
                        Biodefense and Pandemic Vaccine and 
                        Drug Development Act of 2006.
                  (B) Support advanced research and 
                development.--To carry out the purpose 
                described in paragraph (2)(B), the Secretary 
                shall--
                          (i) conduct ongoing searches for, and 
                        support calls for, potential qualified 
                        countermeasures and qualified pandemic 
                        or epidemic products;
                          (ii) direct and coordinate the 
                        countermeasure and product advanced 
                        research and development activities of 
                        the Department of Health and Human 
                        Services;
                          (iii) establish strategic initiatives 
                        to accelerate countermeasure and 
                        product advanced research and 
                        development and innovation in such 
                        areas as the Secretary may identify as 
                        priority unmet need areas; and
                          (iv) award contracts, grants, 
                        cooperative agreements, and enter into 
                        other transactions, for countermeasure 
                        and product advanced research and 
                        development.
                  (C) Facilitating advice.--To carry out the 
                purpose described in paragraph (2)(C) the 
                Secretary shall--
                          (i) connect interested persons with 
                        the offices or employees authorized by 
                        the Secretary to advise such persons 
                        regarding the regulatory requirements 
                        under the Federal Food, Drug, and 
                        Cosmetic Act and under section 351 of 
                        this Act related to the approval, 
                        clearance, or licensure of qualified 
                        countermeasures or qualified pandemic 
                        or epidemic products; and
                          (ii) ensure that, with respect to 
                        persons performing countermeasure and 
                        product advanced research and 
                        development funded under this section, 
                        such offices or employees provide such 
                        advice in a manner that is ongoing and 
                        that is otherwise designated to 
                        facilitate expeditious development of 
                        qualified countermeasures and qualified 
                        pandemic or epidemic products that may 
                        achieve such approval, clearance, or 
                        licensure.
                  (D) Supporting innovation.--To carry out the 
                purpose described in paragraph (2)(D), the 
                Secretary may award contracts, grants, and 
                cooperative agreements, or enter into other 
                transactions, such as prize payments, to 
                promote--
                          (i) innovation in technologies that 
                        may assist countermeasure and product 
                        advanced research and development;
                          (ii) research on and development of 
                        research tools and other devices and 
                        technologies; and
                          (iii) research to promote strategic 
                        initiatives, such as rapid diagnostics, 
                        broad spectrum antimicrobials, and 
                        vaccine manufacturing technologies.
          (5) Transaction authorities.--
                  (A) Other transactions.--In carrying out the 
                functions under subparagraph (B) or (D) of 
                paragraph (4), the Secretary shall have 
                authority to enter into other transactions for 
                countermeasure and product advanced research 
                and development.
                  (B) Expedited authorities.--
                          (i) In general.--In awarding 
                        contracts, grants, and cooperative 
                        agreements, and in entering into other 
                        transactions under subparagraph (B) or 
                        (D) of paragraph (4), the Secretary 
                        shall have the expedited procurement 
                        authorities, the authority to expedite 
                        peer review, and the authority for 
                        personal services contracts, supplied 
                        by subsections (b), (c), and (d) of 
                        section 319F-1.
                          (ii) Application of provisions.--
                        Provisions in such section 319F-1 that 
                        apply to such authorities and that 
                        require institution of internal 
                        controls, limit review, provide for 
                        Federal Tort Claims Act coverage of 
                        personal services contractors, and 
                        commit decisions to the discretion of 
                        the Secretary shall apply to the 
                        authorities as exercised pursuant to 
                        this paragraph.
                          (iii) Authority to limit 
                        competition.--For purposes of applying 
                        section 319F-1(b)(1)(D) to this 
                        paragraph, the phrase ``BioShield 
                        Program under the Project BioShield Act 
                        of 2004'' shall be deemed to mean the 
                        countermeasure and product advanced 
                        research and development program under 
                        this section.
                          (iv) Availability of data.--The 
                        Secretary may require that, as a 
                        condition of being awarded a contract, 
                        grant, cooperative agreement, or other 
                        transaction under subparagraph (B) or 
                        (D) of paragraph (4), a person make 
                        available to the Secretary on an 
                        ongoing basis, and submit upon request 
                        to the Secretary, relevant data related 
                        to or resulting from countermeasure and 
                        product advanced research and 
                        development carried out pursuant to 
                        this section.
                  (C) Advance payments; advertising.--The 
                authority of the Secretary to enter into 
                contracts under this section shall not be 
                limited by section 3324(a) of title 31, United 
                States Code, or by section 3709 of the Revised 
                Statutes of the United States (41 U.S.C. 5).
                  (D) Milestone-based payments allowed.--In 
                awarding contracts, grants, and cooperative 
                agreements, and in entering into other 
                transactions, under this section, the Secretary 
                may use milestone-based awards and payments.
                  (E) Foreign nationals eligible.--The 
                Secretary may under this section award 
                contracts, grants, and cooperative agreements 
                to, and may enter into other transactions with, 
                highly qualified foreign national persons 
                outside the United States, alone or in 
                collaboration with American participants, when 
                such transactions may inure to the benefit of 
                the American people and are consistent with 
                National security.
                  (F) Establishment of advanced research 
                centers.--The Secretary may establish one or 
                more federally-funded research and development 
                centers, or university-affiliated research 
                centers in accordance with section 303(c)(3) of 
                the Federal Property and Administrative 
                Services Act of 1949 (41 U.S.C. 253(c)(3)), 
                provided that such centers are consistent and 
                complementary with the duties described in 
                paragraph (4), and are consistent and 
                complementary with, and deemed necessary after 
                considering the availability of, existing 
                federally-supported basic research programs.
          (6) Vulnerable populations.--In carrying out the 
        functions under this section, the Secretary may give 
        priority to the advanced research and development of 
        qualified countermeasures and qualified pandemic or 
        epidemic products that are likely to be safe and 
        effective with respect to the emergency health security 
        needs of children and other vulnerable populations.
          (7) Personnel authorities.--
                  (A) Specially qualified scientific and 
                professional personnel.--In addition to any 
                other personnel authorities, the Secretary 
                may--
                          (i) without regard to those 
                        provisions of title 5, United States 
                        Code, governing appointments in the 
                        competitive service, appoint highly 
                        qualified individuals to scientific or 
                        professional positions in BARDA, such 
                        as program managers, to carry out this 
                        section; and
                          (ii) compensate them in the same 
                        manner in which individuals appointed 
                        under section 9903 of such title are 
                        compensated, without regard to the 
                        provisions of chapter 51 and subchapter 
                        III of chapter 53 of such title 
                        relating to classification and General 
                        Schedule pay rates.
                  (B) Special consultants.--In carrying out 
                this section, the Secretary may--
                          (i) appoint special consultants 
                        pursuant to section 207(f); and
                          (ii) accept voluntary and 
                        uncompensated services.
  (c) Inapplicability of Certain Provisions.--
          (1) Disclosure.--
                  (A) In general.--The Secretary shall withhold 
                from disclosure under section 552 of title 5, 
                United States Code, specific technical data or 
                scientific information that is created or 
                obtained during the countermeasure and product 
                advanced research and development funded by the 
                Secretary that reveal vulnerabilities of 
                existing medical or public health defenses 
                against biological, chemical, nuclear, or 
                radiological threats. Such information shall be 
                deemed to be information described in section 
                552(b)(3) of title 5, United States Code.
                  (B) Oversight.--Information subject to 
                nondisclosure under subparagraph (A) shall be 
                reviewed by the Secretary every 5 years to 
                determine the relevance or necessity of 
                continued nondisclosure.
          (2) Federal advisory committee act.--Section 14 of 
        the Federal Advisory Committee Act (5 U.S.C. App.) 
        shall not apply to a working group of BARDA or to the 
        National Biodefense Science Board under section 319M.
  (d) Authorization of Appropriations.--For the purpose of 
carrying out advanced research and development under this 
section, there are authorized to be appropriated $160,000,000 
for each of the fiscal years 2007 and 2008. Such authorizations 
are in addition to other authorizations of appropriations that 
are available for such purpose. Amounts appropriated under the 
preceding sentence are available until expended.
  (e) Definitions.--For purposes of this section:
          (1) BARDA.--The term ``BARDA'' means the Biomedical 
        Advanced Research and Development Authority.
          (2) Other transactions.--The term ``other 
        transactions'' means transactions, other than 
        procurement contracts, grants, and cooperative 
        agreements, such as the Secretary of Defense may enter 
        into under section 2371 of title 10, United States 
        Code.
          (3) Qualified countermeasure.--The term ``qualified 
        countermeasure'' has the meaning given such term in 
        section 319F-1.
          (4) Qualified pandemic or epidemic product.--The term 
        ``qualified pandemic or epidemic product'' has the 
        meaning given the term in section 319F-3.
          (5) Advanced research and development.--
                  (A) In general.--The term ``advanced research 
                and development'' means, with respect to a 
                product that is or may become a qualified 
                countermeasure or a qualified pandemic or 
                epidemic product, activities that 
                predominantly--
                          (i) are conducted after basic 
                        research and preclinical development of 
                        the product; and
                          (ii) are related to manufacturing the 
                        product on a commercial scale and in a 
                        form that satisfies the regulatory 
                        requirements under the Federal Food, 
                        Drug, and Cosmetic Act or under section 
                        351 of this Act.
                  (B) Activities included.--The term under 
                subparagraph (A) includes--
                          (i) testing of the product to 
                        determine whether the product may be 
                        approved, cleared, or licensed under 
                        the Federal Food, Drug, and Cosmetic 
                        Act or under section 351 of this Act 
                        for a use that is or may be the basis 
                        for such product becoming a qualified 
                        countermeasure or qualified pandemic or 
                        epidemic product, or to help obtain 
                        such approval, clearance, or license;
                          (ii) design and development of tests 
                        or models, including animal models, for 
                        such testing;
                          (iii) activities to facilitate 
                        manufacture of the product on a 
                        commercial scale with consistently high 
                        quality, as well as to improve and make 
                        available new technologies to increase 
                        manufacturing surge capacity;
                          (iv) activities to improve the shelf-
                        life of the product or technologies for 
                        administering the product; and
                          (v) such other activities as are part 
                        of the advanced stages of testing, 
                        refinement, improvement, or preparation 
                        of the product for such use and as are 
                        specified by the Secretary.
          (6) Research tool.--The term ``research tool'' means 
        a device, technology, biological material, reagent, 
        animal model, computer system, computer software, or 
        analytical technique that is developed to assist in the 
        discovery, development, or manufacture of qualified 
        countermeasures or qualified pandemic or epidemic 
        products.
          (7) Program manager.--The term ``program manager'' 
        means an individual appointed to carry out functions 
        under this section and authorized to provide project 
        oversight and management of strategic initiatives.
          (8) Person.--The term ``person'' includes an 
        individual, partnership, corporation, association, 
        entity, or public or private corporation, and a 
        Federal, State, or local government agency or 
        department.

SEC. 319M. NATIONAL BIODEFENSE SCIENCE BOARD AND WORKING GROUPS.

  (a) In General.--
          (1) Establishment and function.--The Secretary shall 
        establish the National Biodefense Science Board 
        (referred to in this section as the ``Board'') to 
        provide expert advice and guidance to the Secretary on 
        scientific, technical and other matters of special 
        interest to the Department of Health and Human Services 
        regarding current and future chemical, biological, 
        nuclear, and radiological agents, whether naturally 
        occurring, accidental, or deliberate.
          (2) Membership.--The membership of the Board shall be 
        comprised of individuals who represent the Nation's 
        preeminent scientific, public health, and medical 
        experts, as follows--
                  (A) such Federal officials as the Secretary 
                may determine are necessary to support the 
                functions of the Board;
                  (B) four individuals representing the 
                pharmaceutical, biotechnology, and device 
                industries;
                  (C) four individuals representing academia; 
                and
                  (D) five other members as determined 
                appropriate by the Secretary.
          (3) Term of appointment.--A member of the Board 
        described in subparagraph (B), (C), or (D) of paragraph 
        (2) shall serve for a term of 3 years, except that the 
        Secretary may adjust the terms of the initial Board 
        appointees in order to provide for a staggered term of 
        appointment for all members.
          (4) Consecutive appointments; maximum terms.--A 
        member may be appointed to serve not more than 3 terms 
        on the Board and may serve not more than 2 consecutive 
        terms.
          (5) Duties.--The Board shall--
                  (A) advise the Secretary on current and 
                future trends, challenges, and opportunities 
                presented by advances in biological and life 
                sciences, biotechnology, and genetic 
                engineering with respect to threats to 
                biodefense or public health security posed by 
                naturally occurring infectious diseases and 
                chemical, biological, radiological, and nuclear 
                agents;
                  (B) at the request of the Secretary, review 
                and consider any information and findings 
                received from the working groups established 
                under subsection (b); and
                  (C) at the request of the Secretary, provide 
                recommendations and findings for expanded, 
                intensified, and coordinated biodefense 
                research and development activities.
          (6) Meetings.--
                  (A) Initial meeting.--Not later than one year 
                after the date of enactment of the Biodefense 
                and Pandemic Vaccine and Drug Development Act 
                of 2006, the Secretary shall hold the first 
                meeting of the Board.
                  (B) Subsequent meetings.--The Board shall 
                meet at the call of the Secretary, but in no 
                case less than twice annually.
          (7) Vacancies.--Any vacancy in the Board shall not 
        affect its powers, but shall be filled in the same 
        manner as the original appointment.
          (8) Chairperson.--The Secretary shall appoint a 
        chairperson from among the members of the Board.
          (9) Powers.--
                  (A) Hearings.--The Board may hold such 
                hearings, sit and act at such times and places, 
                take such testimony, and receive such evidence 
                as the Board considers advisable to carry out 
                this subsection.
                  (B) Postal services.--The Board may use the 
                United States mails in the same manner and 
                under the same conditions as other departments 
                and agencies of the Federal Government.
          (10) Personnel.--
                  (A) Employees of the federal government.--A 
                member of the Board that is an employee of the 
                Federal Government may not receive additional 
                pay, allowances, or benefits by reason of the 
                member's service on the Board.
                  (B) Other members.--A member of the Board 
                that is not an employee of the Federal 
                Government may be compensated at a rate not to 
                exceed the daily equivalent of the annual rate 
                of basic pay prescribed for level IV of the 
                Executive Schedule under section 5315 of title 
                5, United States Code, for each day (including 
                travel time) during which the member is engaged 
                in the actual performance of duties as a member 
                of the Board.
                  (C) Travel expenses.--Each member of the 
                Board shall receive travel expenses, including 
                per diem in lieu of subsistence, in accordance 
                with applicable provisions under subchapter I 
                of chapter 57 of title 5, United States Code.
                  (D) Detail of government employees.--Any 
                Federal Government employee may be detailed to 
                the Board with the approval for the 
                contributing agency without reimbursement, and 
                such detail shall be without interruption or 
                loss of civil service status or privilege.
  (b) Definitions.--Any term that is defined in section 319L 
and that is used in this section shall have the same meaning in 
this section as such term is given in section 319L.
  (c) Authorization of Appropriations.--There are authorized to 
be appropriated $1,000,000 to carry out this section for each 
of the fiscal years 2007 and 2008.

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FEDERAL FOOD, DRUG, AND COSMETIC ACT

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CHAPTER V--DRUGS AND DEVICES

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Subchapter E--General Provisions Relating to Drugs and Devices

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SEC. 565. TECHNICAL ASSISTANCE.

  The Secretary, in consultation with the Commissioner of Food 
and Drugs, shall establish within the Food and Drug 
Administration a team of experts on manufacturing and 
regulatory activities (including compliance with current Good 
Manufacturing Practice) to provide both off-site and on-site 
technical assistance to the manufacturers of qualified 
countermeasures (as defined in section 319F-1 of the Public 
Health Service Act), security countermeasures (as defined in 
section 319F-2 of such Act), or vaccines, at the request of 
such a manufacturer and at the discretion of the Secretary, if 
the Secretary determines that a shortage or potential shortage 
may occur in the United States in the supply of such vaccines 
or countermeasures and that the provision of such assistance 
would be beneficial in helping alleviate or avert such 
shortage.

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