```

[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5533 Introduced in House (IH)]

109th CONGRESS
  2d Session
                                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.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              June 6, 2006

 Mr. Rogers of Michigan (for himself, Ms. Eshoo, Mr. Hoekstra, and Mr. 
   McHugh) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
To prepare and strengthen the biodefenses of the United States against 
deliberate, accidental, and natural outbreaks of illness, and for other 
                               purposes.

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

SECTION 1. SHORT TITLE.

    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.  7. Rule of construction.

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) Definitions.--In this section:
            ``(1) BARDA.--The term `BARDA' means the Biomedical 
        Advanced Research and Development Authority.
            ``(2) Fund.--The term `Fund' means the Biodefense Medical 
        Countermeasure Development Fund established under subsection 
        (d).
            ``(3) 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.
            ``(4) Qualified countermeasure.--The term `qualified 
        countermeasure' has the meaning given such term in section 
        319F-1.
            ``(5) Qualified pandemic or epidemic product.--The term 
        `qualified pandemic or epidemic product' has the meaning given 
        the term in section 319F-3.
            ``(6) 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.
            ``(7) Research tool.--The term `research tool' means a 
        device, technology, biological material (including a cell line 
        or an antibody), 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.
            ``(8) 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.
            ``(9) 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.
    ``(b) Strategic Plan for Countermeasure Research, Development, and 
Procurement.--
            ``(1) In general.--Not later than 6 months after the date 
        of enactment of the Biodefense and Pandemic Vaccine and Drug 
        Development Act of 2006, the Secretary shall develop, make 
        public, and present to the appropriate Congressional committees 
        a strategic plan to integrate biodefense and emerging 
        infectious disease requirements with the advanced research and 
        development, strategic initiatives for innovation, and the 
        procurement of qualified countermeasures and qualified pandemic 
        or epidemic products. The Secretary shall periodically review 
        and, as appropriate, revise the plan.
            ``(2) Content.--The strategic plan under paragraph (1) 
        shall--
                    ``(A) guide research and development, conducted or 
                supported by the Department of Health and Human 
                Services, of qualified countermeasures and qualified 
                pandemic or epidemic products against possible 
                biological, chemical, radiological, and nuclear agents 
                and to emerging infectious diseases;
                    ``(B) guide innovation in technologies that may 
                assist advanced research and development of qualified 
                countermeasures and qualified pandemic or epidemic 
                products (such research and development referred to in 
                this section as `countermeasure and product advanced 
                research and development');
                    ``(C) guide procurement of such qualified 
                countermeasures and qualified pandemic or epidemic 
                products by such Department;
                    ``(D) include immediate, short-term, and long-term 
                goals;
                    ``(E) include immediate, short-term, and long-term 
                procurement priorities; and
                    ``(F) identify processes used to designate a range 
                of funds available for various types of countermeasure 
                procurements.
    ``(c) 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.--Based upon the strategic plan described 
        in subsection (b), 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 7 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 
                        shall 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, all 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.
                    ``(F) Establishment of 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 
        children, pregnant women, 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.
    ``(d) Fund.--
            ``(1) Establishment.--There is established the Biodefense 
        Medical Countermeasure Development Fund, which shall be 
        available to carry out this section in addition to such amounts 
        as are otherwise available for this purpose.
            ``(2) Funding.--To carry out the purposes of this section, 
        there are authorized to be appropriated to the Fund--
                    ``(A) $1,070,000,000 for fiscal years 2006 through 
                2008, the amounts to remain available until expended; 
                and
                    ``(B) such sums as may be necessary for subsequent 
                fiscal years, the amounts to remain available until 
                expended.
    ``(e) 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.

``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 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) Other Working Groups.--The Secretary may establish a working 
group of experts, or may use an existing working group or advisory 
committee, to--
            ``(1) identify innovative research with the potential to be 
        developed as a qualified countermeasure or a qualified pandemic 
        or epidemic product;
            ``(2) identify accepted animal models for particular 
        diseases and conditions associated with any biological, 
        chemical, radiological, or nuclear agent, any toxin, or any 
        potential pandemic infectious disease, and identify strategies 
        to accelerate animal model and research tool development and 
        validation; and
            ``(3) obtain advice regarding supporting and facilitating 
        advanced research and development related to qualified 
        countermeasures and qualified pandemic or epidemic products 
        that are likely to be safe and effective with respect to 
        children, pregnant women, and other vulnerable populations, and 
        other issues regarding activities under this section that 
        affect such populations.
    ``(c) Definitions.--Any term that is defined in section 319L and 
that is used in this section shall have the same meaning in this 
section as such term is given in section 319L.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated $1,000,000 to carry out this section for fiscal year 2007 
and each fiscal year thereafter.''.

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

    (a) Qualified Countermeasure.--Section 319F-1(a) of the Public 
Health Service Act (42 U.S.C. 247d-6a(a)) is amended by striking 
paragraph (2) and inserting the following:
            ``(2) Definitions.--In this section:
                    ``(A) Qualified countermeasure.--The term 
                `qualified countermeasure' means a drug (as that term 
                is defined by section 201(g)(1) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), 
                biological product (as that term is defined by section 
                351(i) of this Act (42 U.S.C. 262(i))), or device (as 
                that term is defined by section 201(h) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that 
                the Secretary determines to be a priority (consistent 
                with sections 302(2) and 304(a) of the Homeland 
                Security Act of 2002) to--
                            ``(i) diagnose, mitigate, prevent, or treat 
                        harm from any biological agent (including 
                        organisms that cause an infectious disease) or 
                        toxin, chemical, radiological, or nuclear agent 
                        that may cause a public health emergency 
                        affecting national security; or
                            ``(ii) diagnose, mitigate, prevent, or 
                        treat harm from a condition that may result in 
                        adverse health consequences or death and may be 
                        caused by administering a drug, biological 
                        product, or device that is used as described in 
                        this subparagraph.
                    ``(B) Infectious disease.--The term `infectious 
                disease' means a disease potentially caused by a 
                pathogenic organism (including a bacteria, virus, 
                fungus, or parasite) that is acquired by a person and 
                that reproduces in that person.''.
    (b) Security Countermeasure.--Section 319F-2(c)(1)(B)(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, 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.

    (a) Security Countermeasures.--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 advanced 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.--
                                Notwithstanding any other provision of 
                                law or regulation, the Secretary shall, 
                                where possible, 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: ``Such agreements may allow other executive 
                agencies to order qualified and security 
                countermeasures under procurement contracts or other 
                agreements established by the Secretary. 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.''.
    (b) Qualified Countermeasures.--Section 319F-1(b) of the Public 
Health Service Act (42 U.S.C. 247d-6a(b)) is amended by adding at the 
end the following:
            ``(5) Procurement of multiple products and technologies.--
        Notwithstanding any other provision of law or regulation, the 
        Secretary shall, where possible, enter into multiple 
        transactions for the procurement of multiple technologies and 
        products from multiple manufacturers of qualified 
        countermeasures in order to mitigate against the risks 
        associated with dependence on a single supplier or 
        technology.''.

SEC. 7. RULE OF CONSTRUCTION.

    Nothing in this Act, or any amendment made by this Act, shall be 
construed to affect any law that applies to the National Vaccine Injury 
Compensation Program under title XXI of the Public Health Service Act 
(42 U.S.C. 300aa-1 et seq.), including such laws regarding--
            (1) whether claims may be filed or compensation may be paid 
        for a vaccine-related injury or death under such Program;
            (2) claims pending under such Program; and
            (3) any petitions, cases, or other proceedings before the 
        United States Court of Federal Claims pursuant to such title.
                                 <all>
```