[Congressional Record Volume 152, Number 43 (Thursday, April 6, 2006)]
[Senate]
[Pages S3222-S3227]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BURR (for himself, Mr. Frist, Mr. Enzi, Mr. Gregg, Mr. 
        Alexander, and Mrs. Dole):
  S. 2564. A bill to prepare and strengthen the biodefenses of the 
United States against deliberate, accidental, and natural outbreaks of 
illness, and for other purposes; to the Committee on Health, Education, 
Labor, and Pensions.
  Mr. BURR. Mr. President, I ask unanimous consent that the text of the 
bill be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2564

       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.

[[Page S3223]]

       ``(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,

[[Page S3224]]

     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

[[Page S3225]]

       ``(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.--

[[Page S3226]]

       (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)).

[[Page S3227]]

       ``(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.
                                 ______