[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 2564 Introduced in Senate (IS)]








 109th CONGRESS
  2d Session
                                S. 2564

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 6, 2006

 Mr. Burr (for himself, Mr. Frist, Mr. Enzi, Mr. Gregg, Mr. Alexander, 
and Mrs. Dole) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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. Orphan drug market exclusivity for countermeasure products.
Sec. 6. Technical assistance.
Sec. 7. Collaboration and coordination.
Sec. 8. Procurement.
Sec. 9. Rule of construction.

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

    (a) In General.--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) Security countermeasure.--The term `security 
        countermeasure' has the meaning given such term in section 
        319F-2.
            ``(8) 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.
            ``(9) 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.
            ``(10) 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 and make 
        public 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.
            ``(2) Content.--The strategic plan under paragraph (1) 
        shall guide--
                    ``(A) 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) 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'); and
                    ``(C) procurement of such qualified countermeasures 
                and qualified pandemic or epidemic products by such 
                Department.
    ``(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)).
            ``(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.
            ``(2) Funds.--
                    ``(A) First fiscal year.--
                            ``(i) Authorization and appropriation.--
                        There are authorized to be appropriated and 
                        there are appropriated to the Fund $340,000,000 
                        to carry out this section for fiscal year 2007. 
                        Such funds shall remain available until 
                        expended.
                            ``(ii) Authorization of appropriations.--
                        There are authorized to be appropriated, in 
                        addition to the amounts appropriated under 
                        clause (i), $160,000,000 to carry out this 
                        section for fiscal year 2007. Such funds shall 
                        remain available until expended.
                    ``(B) Subsequent fiscal years.--
                            ``(i) In general.--There are authorized to 
                        be appropriated to carry out this section--
                                    ``(I) $500,000,000 for fiscal year 
                                2008; and
                                    ``(II) such sums as may be 
                                necessary for fiscal years 2009 through 
                                2012.
                            ``(ii) Availability of funds.--Such sums 
                        authorized under clause (i) shall 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.''.
    (b) Offset of Funding.--The amount appropriated under the 
subheading ``Biodefense Countermeasures'' under the heading ``Emergency 
Preparedness and Response'' in title III of the Department of Homeland 
Security Appropriations Act, 2004 (Public Law 108-90) shall be 
decreased by $340,000,000.

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) is amended by 
striking ``treat, identify, or prevent'' each place it appears and 
inserting ``diagnose, mitigate, prevent, or treat''.
    (c) Limitation on Use of Funds.--Section 510(a) of the Homeland 
Security Act of 2002 (6 U.S.C. 320(a)) is amended by adding at the end 
the following: ``None of the funds made available under this subsection 
shall be used to procure countermeasures to diagnose, mitigate, 
prevent, or treat harm resulting from any naturally occurring 
infectious disease.''.

SEC. 5. ORPHAN DRUG MARKET EXCLUSIVITY FOR COUNTERMEASURE PRODUCTS.

    (a) In General.--Section 527 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360cc) is amended by adding at the end the 
following:
    ``(c) Market Exclusivities for Countermeasures, Antibiotics, and 
Antiinfectives.--
            ``(1) In general.--Except as provided in paragraph (2), 
        with respect to a drug that is designated under section 526 for 
        a rare disease or condition, the period referred to in this 
        section is deemed to be 10 years in lieu of 7 years if--
                    ``(A) such rare disease or condition is directly 
                caused by a--
                            ``(i)(I) biological agent (including an 
                        organism that causes infectious disease);
                            ``(II) toxin; or
                            ``(III) chemical, radiological, or nuclear 
                        agent; and
                            ``(ii) such biological agent (including an 
                        organism that causes an infectious disease), 
                        toxin, or chemical, radiological or nuclear 
                        agent, is identified as a material threat under 
                        subsection (c)(2)(A)(ii) of section 319F-2 of 
                        the Public Health Service Act;
                    ``(B) such drug is determined by the Secretary to 
                be a security countermeasure under subsection (c)(1)(B) 
                of such section 319F-2 with respect to such agent or 
                toxin;
                    ``(C) no active ingredient (including a salt or 
                ester of the active ingredient) of the drug has been 
                approved under an application under section 505(b) 
                prior to the submission of the request for designation 
                of the new drug under section 526; and
                    ``(D) notice respecting the designation of a drug 
                under section 526 has been made available to the 
                public.
            ``(2) Application of provision.--Paragraph (1) shall apply 
        with respect to an antibiotic drug or antiinfective drug 
        designated under section 526 only if--
                    ``(A) no active ingredient (including a salt or 
                ester of the active ingredient) of such drug has been 
                approved as a feed or water additive for an animal in 
                the absence of any clinical sign of disease in the 
                animal for growth promotion, feed efficiency, weight 
                gain, routine disease prevention, or other routine 
                purpose;
                    ``(B) no active ingredient (including a salt or 
                ester of the active ingredient) of such drug has been 
                approved for use in humans under section 505 or 
                approved for human use under section 507 (as in effect 
                prior to November 21, 1997) prior to the submission of 
                the request for designation of the new drug under 
                section 526;
                    ``(C) the Secretary has made a determination that--
                            ``(i) such drug is not a member of a class 
                        of antibiotics that is particularly prone to 
                        creating antibiotic resistance;
                            ``(ii) sufficient antibiotics do not 
                        already exist in the same class;
                            ``(iii) such drug represents a significant 
                        clinical improvement over other antibiotic 
                        drugs;
                            ``(iv) such drug is for a serious or life-
                        threatening disease or conditions; and
                            ``(v) such drug is for a countermeasure 
                        use; and
                    ``(D) notice respecting the designation of a drug 
                under section 526 has been made available to the 
                public.
            ``(3) Rule of construction.--With respect to a drug to 
        which this subsection applies, and which is also approved for 
        additional uses to which this subsection does not apply, 
        nothing in section 505(b)(2) or 505(j) shall prohibit the 
        Secretary from approving a drug under section 505(b)(2) or 
        505(j) with different or additional labeling for the drug as 
        the Secretary deems necessary to ensure that the drug is safe 
        and effective for the uses to which this subsection does not 
        apply.
            ``(4) Study and report.--Not later than January 1, 2011, 
        the Comptroller General of the United States shall conduct a 
        study and submit to Congress a report concerning the effect of 
        and activities under this subsection. Such study and report 
        shall examine all relevant issues including--
                    ``(A) the effectiveness of this subsection in 
                improving the availability of novel countermeasures for 
                procurement under section 319F-2 of the Public Health 
                Service Act;
                    ``(B) the effectiveness of this subsection in 
                improving the availability of drugs that treat serious 
                or life threatening diseases or conditions and offer 
                significant clinical improvements;
                    ``(C) the continued need for additional incentives 
                to create more antibiotics and antiinfectives;
                    ``(D) the economic impact of the section on 
                taxpayers and consumers, including--
                            ``(i) the economic value of additional 
                        drugs provided for under this subsection, 
                        including the impact of improved health care 
                        and hospitalization times associated with 
                        treatment of nosocomial infections; and
                            ``(ii) the economic cost of any delay in 
                        the availability of lower cost generic drugs on 
                        patients, the insured, and Federal and private 
                        health plans;
                    ``(E) the adequacy of limits under subparagraphs 
                (A) and (B) of paragraph (2) to maximize the useful 
                period during which antibiotic drugs or antiinfective 
                drugs remain therapeutically useful treatments; and
                    ``(F) any recommendations for modifications to this 
                subsection that the Comptroller determines to be 
                appropriate.
            ``(5) Effective date.--This subsection shall apply only to 
        products for which an applicant has applied for designation 
        under section 526 after the date of enactment of the Biodefense 
        and Pandemic Vaccine and Drug Development Act of 2006.
            ``(6) Sunset.--This subsection shall not apply with respect 
        to any designation of a drug under section 526 made by the 
        Secretary on or after October 1, 2011.''.

SEC. 6. 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. 7. COLLABORATION AND COORDINATION.

    (a) Limited Antitrust Exemption.--
            (1) Meetings and consultations to discuss security 
        countermeasures, qualified countermeasures, or qualified 
        pandemic or epidemic product development.--
                    (A) Authority to conduct meetings and 
                consultations.--The Secretary of Health and Human 
                Services (referred to in this subsection as the 
                ``Secretary''), in coordination with the Attorney 
                General and the Secretary of Homeland Security, may 
                conduct meetings and consultations with persons engaged 
                in the development of a security countermeasure (as 
                defined in section 319F-2 of the Public Health Service 
                Act (42 U.S.C. 247d-6b)) (as amended by this Act), a 
                qualified countermeasure (as defined in section 319F-1 
                of the Public Health Service Act (42 U.S.C. 247d-6a)) 
                (as amended by this Act), or a qualified pandemic or 
                epidemic product (as defined in section 319F-3 of the 
                Public Health Service Act (42 U.S.C. 247d-6d)) for the 
                purpose of the development, manufacture, distribution, 
                purchase, or storage of a countermeasure or product. 
                The Secretary may convene such meeting or consultation 
                at the request of the Secretary of Homeland Security, 
                the Attorney General, the Chairman of the Federal Trade 
                Commission (referred to in this section as the 
                ``Chairman''), or any interested person, or upon 
                initiation by the Secretary. The Secretary shall give 
                prior notice of any such meeting or consultation, and 
                the topics to be discussed, to the Attorney General, 
                the Chairman, and the Secretary of Homeland Security.
                    (B) Meeting and consultation conditions.--A meeting 
                or consultation conducted under subparagraph (A) 
                shall--
                            (i) be chaired or, in the case of a 
                        consultation, facilitated by the Secretary;
                            (ii) be open to persons involved in the 
                        development, manufacture, distribution, 
                        purchase, or storage of a countermeasure or 
                        product, as determined by the Secretary;
                            (iii) be open to the Attorney General, the 
                        Secretary of Homeland Security, and the 
                        Chairman;
                            (iv) be limited to discussions involving 
                        covered activities; and
                            (v) be conducted in such manner as to 
                        ensure that no national security, confidential 
                        commercial, or proprietary information is 
                        disclosed outside the meeting or consultation.
                    (C) Limitation.--The Secretary may not require 
                participants to disclose confidential commercial or 
                proprietary information.
                    (D) Transcript.--The Secretary shall maintain a 
                complete verbatim transcript of each meeting or 
                consultation conducted under this subsection, which 
                shall not be disclosed under section 552 of title 5, 
                United States Code, unless such Secretary, in 
                consultation with the Attorney General and the 
                Secretary of Homeland Security, determines that 
                disclosure would pose no threat to national security. 
                The determination regarding possible threats to 
                national security shall not be subject to judicial 
                review.
                    (E) Exemption.--
                            (i) In general.--Subject to clause (ii), it 
                        shall not be a violation of the antitrust laws 
                        for any person to participate in a meeting or 
                        consultation conducted in accordance with this 
                        paragraph.
                            (ii) Limitation.--Clause (i) shall not 
                        apply to any agreement or conduct that results 
                        from a meeting or consultation and that is not 
                        covered by an exemption granted under paragraph 
                        (4).
            (2) Submission of written agreements.--The Secretary shall 
        submit each written agreement regarding covered activities that 
        is made pursuant to meetings or consultations conducted under 
        paragraph (1) to the Attorney General and the Chairman for 
        consideration. In addition to the proposed agreement itself, 
        any submission shall include--
                    (A) an explanation of the intended purpose of the 
                agreement;
                    (B) a specific statement of the substance of the 
                agreement;
                    (C) a description of the methods that will be 
                utilized to achieve the objectives of the agreement;
                    (D) an explanation of the necessity for a 
                cooperative effort among the particular participating 
                persons to achieve the objectives of the agreement; and
                    (E) any other relevant information determined 
                necessary by the Attorney General, in consultation with 
                the Chairman and the Secretary.
            (3) Exemption for conduct under approved agreement.--It 
        shall not be a violation of the antitrust laws for a person to 
        engage in conduct in accordance with a written agreement to the 
        extent that such agreement has been granted an exemption under 
        paragraph (4), during the period for which the exemption is in 
        effect.
            (4) Action on written agreements.--
                    (A) In general.--The Attorney General, in 
                consultation with the Chairman, shall grant, deny, 
                grant in part and deny in part, or propose 
                modifications to an exemption request regarding a 
                written agreement submitted under paragraph (2), in a 
                written statement to the Secretary, within 15 business 
                days of the receipt of such request. An exemption 
                granted under this paragraph shall take effect 
                immediately.
                    (B) Extension.--The Attorney General may extend the 
                15-day period referred to in subparagraph (A) for an 
                additional period of not to exceed 10 business days.
                    (C) Determination.--An exemption shall be granted 
                regarding a written agreement submitted in accordance 
                with paragraph (2) only to the extent that the Attorney 
                General, in consultation with the Chairman and the 
                Secretary, finds that the conduct that will be exempted 
                will not have any substantial anticompetitive effect 
                that is not reasonably necessary for ensuring the 
                availability of the countermeasure or product involved.
            (5) Limitation on and renewal of exemptions.--An exemption 
        granted under paragraph (4) shall be limited to covered 
        activities, and such exemption shall be renewed (with 
        modifications, as appropriate, consistent with the finding 
        described in paragraph (4)(C)), on the date that is 3 years 
        after the date on which the exemption is granted unless the 
        Attorney General in consultation with the Chairman determines 
        that the exemption should not be renewed (with modifications, 
        as appropriate) considering the factors described in paragraph 
        (4).
            (6) Authority to obtain information.--Consideration by the 
        Attorney General for granting or renewing an exemption 
        submitted under this section shall be considered an antitrust 
        investigation for purposes of the Antitrust Civil Process Act 
        (15 U.S.C. 1311 et seq.).
            (7) Limitation on parties.--The use of any information 
        acquired under an agreement for which an exemption has been 
        granted under paragraph (4), for any purpose other than 
        specified in the exemption, shall be subject to the antitrust 
        laws and any other applicable laws.
            (8) Report.--Not later than one year after the date of 
        enactment of this Act and biannually thereafter, the Attorney 
        General and the Chairman shall report to Congress on the use of 
        the exemption from the antitrust laws provided by this 
        subsection.
    (b) Sunset.--The applicability of this section shall expire at the 
end of the 6-year period that begins on the date of enactment of this 
Act.
    (c) Definitions.--In this section:
            (1) Antitrust laws.--The term ``antitrust laws''--
                    (A) has the meaning given such term in subsection 
                (a) of the first section of the Clayton Act (15 U.S.C. 
                12(a)), except that such term includes section 5 of the 
                Federal Trade Commission Act (15 U.S.C. 45) to the 
                extent such section 5 applies to unfair methods of 
                competition; and
                    (B) includes any State law similar to the laws 
                referred to in subparagraph (A).
            (2) Countermeasure or product.--The term ``countermeasure 
        or product'' refers to a security countermeasure, qualified 
        countermeasure, or qualified pandemic or epidemic product (as 
        those terms are defined in subsection (a)(1)).
            (3) Covered activities.--
                    (A) In general.--Except as provided in subparagraph 
                (B), the term ``covered activities'' includes any 
                activity relating to the development, manufacture, 
                distribution, purchase, or storage of a countermeasure 
                or product.
                    (B) Exception.--The term ``covered activities'' 
                shall not include, with respect to a meeting or 
                consultation conducted under subsection (a)(1) or an 
                agreement for which an exemption has been granted under 
                subsection (a)(4), the following activities involving 2 
                or more persons:
                            (i) Exchanging information among 
                        competitors relating to costs, profitability, 
                        or distribution of any product, process, or 
                        service if such information is not reasonably 
                        necessary to carry out covered activities--
                                    (I) with respect to a 
                                countermeasure or product regarding 
                                which such meeting or consultation is 
                                being conducted; or
                                    (II) that are described in the 
                                agreement as exempted.
                            (ii) Entering into any agreement or 
                        engaging in any other conduct--
                                    (I) to restrict or require the 
                                sale, licensing, or sharing of 
                                inventions, developments, products, 
                                processes, or services not developed 
                                through, produced by, or distributed or 
                                sold through such covered activities; 
                                or
                                    (II) to restrict or require 
                                participation, by any person 
                                participating in such covered 
                                activities, in other research and 
                                development activities, except as 
                                reasonably necessary to prevent the 
                                misappropriation of proprietary 
                                information contributed by any person 
                                participating in such covered 
                                activities or of the results of such 
                                covered activities.
                            (iii) Entering into any agreement or 
                        engaging in any other conduct allocating a 
                        market with a competitor that is not expressly 
                        exempted from the antitrust laws under 
                        subsection (a)(4).
                            (iv) Exchanging information among 
                        competitors relating to production (other than 
                        production by such covered activities) of a 
                        product, process, or service if such 
                        information is not reasonably necessary to 
                        carry out such covered activities.
                            (v) Entering into any agreement or engaging 
                        in any other conduct restricting, requiring, or 
                        otherwise involving the production of a 
                        product, process, or service that is not 
                        expressly exempted from the antitrust laws 
                        under subsection (a)(4).
                            (vi) Except as otherwise provided in this 
                        subsection, entering into any agreement or 
                        engaging in any other conduct to restrict or 
                        require participation by any person 
                        participating in such covered activities, in 
                        any unilateral or joint activity that is not 
                        reasonably necessary to carry out such covered 
                        activities.
                            (vii) Entering into any agreement or 
                        engaging in any other conduct restricting or 
                        setting the price at which a countermeasure or 
                        product is offered for sale, whether by bid or 
                        otherwise.

SEC. 8. 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 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) 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)).
                                    ``(VIII) 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.
                                    ``(IX) 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.''.

SEC. 9. 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>