[Congressional Record (Bound Edition), Volume 152 (2006), Part 15]
[House]
[Pages 19862-19868]
[From the U.S. Government Publishing Office, www.gpo.gov]




    BIODEFENSE AND PANDEMIC VACCINE AND DRUG DEVELOPMENT ACT OF 2006

  Mr. DEAL of Georgia. Mr. Speaker, I move to suspend the rules and 
pass the bill (H.R. 5533) to prepare and strengthen the biodefenses of 
the United States against deliberate, accidental, and natural outbreaks 
of illness, and for other purposes, as amended.
  The Clerk read as follows:

                               H.R. 5533

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

     SECTION 1. SHORT TITLE.

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

     SEC. 2. TABLE OF CONTENTS.

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

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

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

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

       ``(a) Biomedical Advanced Research and Development 
     Authority.--
       ``(1) Establishment.--There is established within the 
     Department of Health and Human Services the Biomedical 
     Advanced Research and Development Authority.
       ``(2) In general.--The Secretary shall coordinate and 
     oversee the acceleration of countermeasure and product 
     advanced research and development by--
       ``(A) facilitating collaboration among the Department of 
     Health and Human Services, other Federal agencies, relevant 
     industries, academia, and other persons, with respect to such 
     advanced research and development;
       ``(B) promoting countermeasure and product advanced 
     research and development;
       ``(C) facilitating contacts between interested persons and 
     the offices or employees authorized by the Secretary to 
     advise such persons regarding requirements under the Federal 
     Food, Drug, and Cosmetic Act and under section 351 of this 
     Act; and
       ``(D) promoting innovation to reduce the time and cost of 
     countermeasure and product advanced research and development.
       ``(3) Director.--The BARDA shall be headed by a Director 
     (referred to in this section as the `Director') who shall be 
     appointed by the Secretary and to whom the Secretary shall 
     delegate such functions and authorities as necessary to 
     implement this section.
       ``(4) Duties.--
       ``(A) Collaboration.--To carry out the purpose described in 
     paragraph (2)(A), the Secretary shall--
       ``(i) facilitate and increase the expeditious and direct 
     communication between the Department of Health and Human 
     Services and relevant persons with respect to countermeasure 
     and product advanced research and development, including by--

       ``(I) facilitating such communication regarding the 
     processes for procuring such advanced research and 
     development with respect to qualified countermeasures and 
     qualified pandemic or epidemic products of interest; and
       ``(II) soliciting information about and data from research 
     on potential qualified countermeasures and qualified pandemic 
     or epidemic products and related technologies;

       ``(ii) at least annually--

       ``(I) convene meetings with representatives from relevant 
     industries, academia, other Federal agencies, international 
     agencies as appropriate, and other interested persons;
       ``(II) sponsor opportunities to demonstrate the operation 
     and effectiveness of relevant biodefense countermeasure 
     technologies; and
       ``(III) convene such working groups on countermeasure and 
     product advanced research and development as the Secretary 
     may determine are necessary to carry out this section; and

       ``(iii) carry out the activities described in section 6 of 
     the Biodefense and Pandemic Vaccine and Drug Development Act 
     of 2006.
       ``(B) Support advanced research and development.--To carry 
     out the purpose described in paragraph (2)(B), the Secretary 
     shall--
       ``(i) conduct ongoing searches for, and support calls for, 
     potential qualified countermeasures and qualified pandemic or 
     epidemic products;
       ``(ii) direct and coordinate the countermeasure and product 
     advanced research and development activities of the 
     Department of Health and Human Services;
       ``(iii) establish strategic initiatives to accelerate 
     countermeasure and product advanced research and development 
     and innovation in such areas as the Secretary may identify as 
     priority unmet need areas; and
       ``(iv) award contracts, grants, cooperative agreements, and 
     enter into other transactions, for countermeasure and product 
     advanced research and development.
       ``(C) Facilitating advice.--To carry out the purpose 
     described in paragraph (2)(C) the Secretary shall--
       ``(i) connect interested persons with the offices or 
     employees authorized by the Secretary to advise such persons 
     regarding the regulatory requirements under the Federal Food, 
     Drug, and Cosmetic Act and under section 351 of this Act 
     related to the approval, clearance, or licensure of qualified 
     countermeasures or qualified pandemic or epidemic products; 
     and
       ``(ii) ensure that, with respect to persons performing 
     countermeasure and product advanced research and development 
     funded under this section, such offices or employees provide 
     such advice in a manner that is ongoing and that is otherwise 
     designated to facilitate expeditious development of qualified 
     countermeasures and qualified pandemic or epidemic products 
     that may achieve such approval, clearance, or licensure.

[[Page 19863]]

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

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

       ``(a) In General.--
       ``(1) Establishment and function.--The Secretary shall 
     establish the National Biodefense Science Board (referred to 
     in this section as the `Board') to provide expert advice and 
     guidance to the Secretary on scientific, technical and other 
     matters of special interest to the Department of Health and 
     Human Services regarding current and future chemical, 
     biological, nuclear, and radiological agents, whether 
     naturally occurring, accidental, or deliberate.
       ``(2) Membership.--The membership of the Board shall be 
     comprised of individuals who represent the Nation's 
     preeminent scientific, public health, and medical experts, as 
     follows--
       ``(A) such Federal officials as the Secretary may determine 
     are necessary to support the functions of the Board;
       ``(B) four individuals representing the pharmaceutical, 
     biotechnology, and device industries;
       ``(C) four individuals representing academia; and

[[Page 19864]]

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

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

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

     SEC. 5. TECHNICAL ASSISTANCE.

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

     ``SEC. 565. TECHNICAL ASSISTANCE.

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

     SEC. 6. PROCUREMENT.

       Section 319F-2 of the Public Health Service Act (42 U.S.C. 
     247d-6b) is amended--
       (1) in the section heading, by inserting ``AND SECURITY 
     COUNTERMEASURE PROCUREMENTS'' before the period; and
       (2) in subsection (c)--
       (A) in the subsection heading, by striking ``Biomedical'';
       (B) in paragraph (5)(B)(i), by striking ``to meet the needs 
     of the stockpile'' and inserting ``to meet the stockpile 
     needs'';
       (C) in paragraph (7)(B)--
       (i) by striking the subparagraph heading and all that 
     follows through ``Homeland Security Secretary'' and inserting 
     the following: ``Interagency agreement; cost.--The Homeland 
     Security Secretary''; and
       (ii) by striking clause (ii);
       (D) in paragraph (7)(C)(ii)--
       (i) by amending clause (I) to read as follows:

       ``(I) Payment conditioned on delivery.--The contract shall 
     provide that no payment may be made until delivery of a 
     portion, acceptable to the Secretary, of the total number of 
     units contracted for, except that, notwithstanding any other 
     provision of law, the contract may provide that, if the 
     Secretary determines (in the Secretary's discretion) that an 
     advance payment, partial payment for significant milestones, 
     or payment to increase manufacturing capacity is necessary to 
     ensure success of a project, the Secretary shall pay an 
     amount, not to exceed 10 percent of the contract amount, in 
     advance of delivery. The Secretary shall, to the extent 
     practicable, make the determination of advance payment at the 
     same time as the issuance of a solicitation. The contract 
     shall provide that such advance payment is required to be 
     repaid if there is a failure to perform by the vendor under 
     the contract. The contract may also provide for additional 
     advance payments of 5 percent each for meeting the milestones 
     specified in such contract. Provided that the specified 
     milestones are reached, these advance payments of 5 percent 
     shall not be required to be repaid. Nothing in this subclause 
     shall be construed as affecting the rights of vendors under 
     provisions of law or regulation (including the Federal 
     Acquisition Regulation) relating to the termination of 
     contracts for the convenience of the Government.''; and

       (ii) by adding at the end the following:

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

       ``(aa) the dosing and administration requirements for 
     countermeasures to be developed and procured;
       ``(bb) the amount of funding that will be dedicated by the 
     Secretary for development and acquisition of the 
     countermeasure; and

[[Page 19865]]

       ``(cc) the specifications the countermeasure must meet to 
     qualify for procurement under a contract under this 
     section.''; and
       (E) in paragraph (8)(A), by adding at the end the 
     following: ``In the case of such agreements by the Secretary, 
     the Secretary may allow other executive agencies to order 
     qualified and security countermeasures under procurement 
     contracts or other agreements established by the Secretary, 
     and such ordering process (including transfers of 
     appropriated funds between an agency and the Department of 
     Health and Human Services as reimbursements for such orders 
     for countermeasures) may be conducted under the authority of 
     section 1535 of title 31, United States Code, except that all 
     such orders shall be processed under the terms established 
     under this section for the procurement of countermeasures.''

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Georgia (Mr. Deal) and the gentlewoman from California (Ms. Eshoo) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Georgia.


                             General Leave

  Mr. DEAL of Georgia. Mr. Speaker, I ask unanimous consent that all 
Members may have 5 legislative days within which to revise and extend 
their remarks on this legislation and insert extraneous material on the 
bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Georgia?
  There was no objection.
  Mr. DEAL of Georgia. Mr. Speaker, I yield myself such time as I may 
consume.
  I rise today in strong support of H.R. 5533, the Biodefense and 
Pandemic Vaccine and Drug Development Act of 2006.
  Like the NIH Reform Act that we will be considering later this 
evening, this legislation is the end product of a cooperative, 
bipartisan effort to help improve research outputs for the benefit of 
all Americans should the unspeakable happen here again on American 
soil.
  As my colleagues are no doubt aware, biodefense is an area where the 
Federal Government must take a strong role because there is no business 
model that will support the investments we need without a clear path 
from the Federal Government. However, we also know that the expertise 
in this area mostly lies with the private sector, so we must make sure 
that we facilitate a strong working partnership.
  Project BioShield was signed into law on July 21, 2004, to help 
encourage the development of new bioterrorism countermeasures. The 
legislation provided procedures for bioterrorism-related procurement, 
hiring and awarding of research grants in an effort to make it easier 
for United States Department of Health and Human Services to quickly 
commit substantial funds to countermeasure projects.
  This past April, the Subcommittee on Health held a hearing on Project 
BioShield; and at this hearing our expert witnesses identified a number 
of barriers to fully realizing Project BioShield's potential. They 
highlighted the fact that there is no single point of authority within 
the Department of Health and Human Services for the advanced research 
and development of medical countermeasures to make important 
procurement decisions. Additionally, HHS has limited purchasing and 
contractual flexibility, and this inefficient structure and limited 
flexibility exacerbates the shortcomings of the status quo.
  Drug and vaccine development is unnecessarily lengthy, often taking 
between 8 and 12 years, and many potential products fail prematurely 
following basic research due to limited funding for advanced research 
and development. There simply is not enough motivation for academic 
researchers, drug and vaccine manufacturers and other possible partners 
to commit substantial resources to bring new and improved products to 
the market quickly.
  I believe that the legislation before us today helps address the 
problems raised in our hearing and represents a huge improvement over 
the status quo.
  I would like to commend the chairman of our Energy and Commerce 
Committee, Chairman Barton of Texas; Congressman Mike Rogers of 
Michigan; and Congresswoman Anna Eshoo of California for their strong 
leadership on this legislation that builds on the achievements of the 
Project BioShield Act and takes further steps to identify and promote 
medical countermeasures to bioterrorism and other public health 
emergencies, including potential pandemic infectious diseases.
  I urge my colleagues to support this legislation.
  Mr. Speaker, I reserve the balance of my time.
  Ms. ESHOO. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I am really proud to be the Democratic sponsor of this 
bill; and I want to salute my friend and my colleague, Representative 
Rogers, for the work that he has done. We have really enjoyed working 
together, and I think that the best part of this all is that our work 
has really produced something that is important for the American 
people. So I want to thank him for everything that he has done to see 
that the bill is on the floor today.
  This legislation really addresses a very urgent issue which is 
critical to our Nation's security and our public health.
  A month after the 9/11 attacks on New York and Washington, our 
country was attacked again. When we were attacked that second time, it 
was when envelopes of anthrax spores were mailed to several media 
outlets and congressional offices. The attacks killed five people, they 
crippled our mail service here on the Hill and cost hundreds of 
millions of dollars to clean up.
  We are now observing the spread of a virulent new strain of Avian 
influenza, the so-called Asian bird flu, in Asia and around the world, 
causing nearly 150 deaths and threatening to become the next deadly 
pandemic.
  Whether the threat is man-made bioterrorism or a highly infectious 
disease, our country is at risk, and we are losing precious time in the 
race to develop effective countermeasures that could save thousands or 
even millions of lives.
  In hearings earlier this year on the Project BioShield Act, it was 
apparent that gaps remained in our effort to address these threats to 
the public health.
  In particular, we learned that very few companies are willing to risk 
their limited resources to develop the vaccines and the antidotes to 
respond to chemical, biological, radiological or nuclear attacks or to 
a fast-spreading influenza.
  Given the risks and the costs involved, it is not surprising that 
companies would rather pursue the next blockbuster cancer medicine or 
cholesterol medicine rather than take a chance on an uncertain market 
where the government is likely to be the only customer.
  So having heard this in the hearings, we rolled our sleeves up. We 
understood that Project BioShield does not address the problem. While 
the law set aside $5.6 billion over 10 years to obtain drugs for the 
Strategic National Stockpile, companies receive very little 
compensation until they can deliver a minimum number of doses. As a 
result, many of these potential drugs languish in the laboratory in 
what is known as the ``Valley of Death.''
  As with any drug, the development of biodefense drugs require 
efficacy trials, toxicity testing, production design and a range of 
other activities that are expensive but necessary to determine whether 
a drug will work, whether it is safe and how it will be manufactured.
  The centerpiece of this legislation that we are on the floor on 
behalf of this evening develops a new, or places a new office within 
HHS, the Biomedical Advanced Research and Development Authority, BARDA, 
which would be a single point of Federal authority for the development 
of medical countermeasures.
  This bill will empower BARDA to make milestone payments to drug 
developers at key stages of their work, helping to reduce financial 
risks of taking on this great challenge. In other words, we are going 
to get the job done.
  I urge my colleagues to support this important legislation, which 
will ensure that our country does its best to prepare for the worst.
  Mr. Speaker, I reserve the balance of my time.
  Mr. DEAL of Georgia. Mr. Speaker, I am pleased to yield 5 minutes to 
the

[[Page 19866]]

gentleman from Michigan (Mr. Rogers), the author of the legislation.
  Mr. ROGERS of Michigan. Mr. Speaker, I rise today in strong support 
of H.R. 5533, the Biodefense and Pandemic Vaccine and Drug Development 
Act of 2006.
  I would like to thank Chairman Barton and Chairman Deal and the 
Energy Committee staff for their continued support on this effort.
  I want to thank my colleague and friend, Congresswoman Anna Eshoo, 
and her staff for your commitment, your energy, your counsel and your 
enthusiasm to get this bill as far as we have come. Thank you very 
much. It has been a joy to work with you.
  And I have to say at the time of this intense pre-election 
partisanship, I am thankful that we might serve as an example to many, 
that you can reach across the aisle to pass important legislation that 
affects the American people so deeply as their future security, the 
security of their children and their families and the well-being of the 
United States of America. Thank you for working with us. I appreciated 
the opportunity to do that.
  I would also like to recognize the administration and their 
willingness to work with us to build upon Project BioShield, of which 
they really led the charge. We found that it was not sufficient, it 
needed some improvement, but it was very forward leaning of this 
President to come out and establish for the first time BioShield, 
knowing that the threat was real from terrorists around the country and 
trying to develop at least a program that would deal with the bioterror 
threat to the United States. They have been so willing to work with us 
in finding out what worked and what did not work and this second round 
we think improves BioShield dramatically and really has to happen if we 
are going to have protection against biothreats in the future.
  The efforts include both offensive and defensive ways to find new 
developments and better treatments for those infected by bioterrorist 
attacks and naturally occurring attacks, as was mentioned by the 
mention of the bird flu.
  The problems that we have discovered in looking at BioShield was that 
there was no single point of authority within HHS for the advanced 
research and development of countermeasures and quick procurement 
decisions, and, really, there is only one customer for these type of 
vaccines, and this is the place where we found some difficulty. There 
is really only one customer, and that customer is the people of the 
United States, the government of the United States. With a single 
source contract it is very hard to attract venture capital, very hard 
to get private industry excited about developing something if they did 
not know where the Federal Government was going to be when it came to 
purchasing something that we are the only ones that were going to buy 
it, a hard place to be.
  So we came up with the single point of authority to make quick 
decisions; and the Valley of Death takes a long time, 8 to 12 years, to 
develop these vaccines, very labor intensive, a lot of intellectual 
power applied to coming up with the right vaccine to be the right 
prophylactic for what we know is a bioterrorism or natural-occurring 
event. That Valley of Death, because we are the single source of those 
contracts, was very real and stalling what we know is great research to 
happen for the cure and the development of these vaccines.
  Also, we found that it did not motivate academic researchers, drug 
and vaccine manufacturers and other possible partners to commit 
substantial resources.

                              {time}  2000

  What this bill does, Mr. Speaker, is address all those issues and 
gives us a framework to go forward and bring out the best in our 
scientific community, our academic community, our producing community 
to come up with the right safety net for the protection of the United 
States when it comes to bioterror threats and natural occurring threats 
in and around our societies, which we know is already here, bird flu 
mentioned, but we also know the real threat of bioterrorism as well.
  I would hope, Mr. Speaker, that we could encourage the Senate to take 
our lead here and set aside any partisanship that may arise in the 
course of this bill in the Senate and take quick action. This really 
means the safety and security of every family in this country. 
Bioterrorism is, unfortunately, a reality in 2006 and beyond; and they 
need to set aside any differences they may have in the Senate and take 
this bill up. So I would encourage Senate Democrat leadership to do 
just that.
  I would also commend Senator Byrd, who has created this bipartisan 
product, and urge they move this product as soon as possible. And I 
would also urge, Mr. Speaker, that this important piece of legislation 
be passed as quickly as possible.
  Ms. ESHOO. Mr. Speaker, I just want to close. I do not think I have 
any other individuals to come to the floor to speak on this this 
evening.
  I also want to thank our staffs, because they have worked exceedingly 
hard and exceedingly well with one another, both from Mr. Rogers' 
staff, certainly mine, with Steve Keenan and Jennifer Nieto, and 
everyone that helped them in my office, as well as John Ford on the 
minority staff of the committee, as well as the majority staff. I 
salute all of you. I thank you. I am proud of the work we have been 
able to do.
  Mr. DINGELL. Mr. Speaker, I rise in support of H.R. 5533, the 
``Biodefense and Pandemic Vaccine and Drug Development Act of 2006''.
  In an effort to respond to the new era of heightened threats to our 
national security and the increased risk of harm to Americans, Congress 
passed the ``Project Bioshield Act'' in July of 2004. The basic purpose 
of Project Bioshield was to support research that would lead to the 
development and availability of ``countermeasures'' to combat public 
health emergencies that threaten our national security. The main 
provisions of this law included: (1) flexible procedures for 
bioterrorism-related procurement, hiring of personnel, and awarding of 
research grants; (2) guaranteeing a Federal Government market for new 
biomedical countermeasures; and (3) permitting emergency use of 
unapproved countermeasures.
  Building on the Project Bioshield Act, H.R. 5533 takes further steps 
to identify potential medical countermeasures to protect the public 
health and national security from biological, chemical, radiological, 
and nuclear threats. Additionally, this legislation ensures the rapid 
development of medical countermeasures against such threats, including 
potential pandemic infectious diseases and it seeks to expand the 
collaboration and coordination between government and the private 
sector so that we can effectively respond in the event of a public 
health emergency.
  Since the implementation of Project Bioshield, it has become apparent 
that certain barriers still exist to the development of 
countermeasures. Many promising countermeasures are not making it 
through the advanced research and development stages necessary to bring 
products to the point of eligibility for procurement. H.R. 5533 seeks 
to rectify this impediment to advanced-stage countermeasure 
development.
  This legislation seeks to streamline the countermeasure research and 
development process and create a single point of Federal authority by 
creating a new office called the Biomedical Advanced Research and 
Development Agency (BARDA) within the Department of Health and Human 
Services. BARDA would establish a ``one stop shop'' agency for advanced 
research and development of medical countermeasures, including drugs 
and vaccines to respond to bioterrorism and natural disease outbreaks. 
This agency would be responsible for directing and coordinating 
collaboration among HHS entities, other Federal agencies, relevant 
industries, academia, and other individuals with respect to 
countermeasure research and development.
  I commend my colleagues, Representatives Eshoo and Rogers, for their 
diligent and impassioned work on this issue. This is a good bill and I 
urge my colleagues to support it.
  Mr. BARTON of Texas. Mr. Speaker, please include this exchange of 
correspondence in the Record for H.R. 5533.

                                         House of Representatives,


                             Committee on Energy and Commerce,

                               Washington, DC, September 26, 2006.
     Hon. Tom Davis,
     Chairman, Committee on Government Reform,
     House of Representatives, Washington, DC.
       Dear Chairman Davis: I acknowledge and appreciate your 
     willingness not to exercise your referral of H.R. 5533, 
     Biodefense and

[[Page 19867]]

     Pandemic Vaccine and Drug Development Act of 2006. In doing 
     so, I agree that your decision to forgo further action on the 
     bill will not prejudice the Committee on Government Reform 
     with respect to its jurisdictional prerogatives on this 
     legislation or similar legislation.
       Further, I recognize your right to request conferees on 
     those provisions within the Committee on Government Reform's 
     jurisdiction should they be the subject of a House-Senate 
     conference on this or similar legislation.
       I will include your letter and this response in the 
     Congressional Record during floor consideration of H.R. 5533.
           Sincerely
                                                       Joe Barton,
                                                         Chairman.
                                  ____
                                  
                                         House of Representatives,


                               Committee on Government Reform,

                              Washington, DC., September 26, 2006.
     Hon. Joe Barton,
     Chairman, House Committee on Energy and Commerce,
     Rayburn House Office Building, Washington, DC.
       Dear Mr. Chairman: On September 20, 2006, the House 
     Committee on Energy and Commerce reported H.R. 5533, the 
     Biodefense and Pandemic Vaccine and Drug Development Act of 
     2006. As you know, the bill includes provisions within the 
     jurisdiction of the Committee on Government Reform, 
     specifically section 3 of the bill that would exempt the 
     Authority proposed to be created by this legislation from 
     portions of the Federal Advisory Committee Act and the 
     Freedom of Information Act. Section 3 would also authorize 
     the Secretary of Health and Human Services to utilize ``other 
     transaction'' procurement authority.
       In the interests of moving this important legislation 
     forward, I agreed to waive sequential consideration of this 
     bill by the Committee on Government Reform. However, I did so 
     only with the understanding that this procedural route would 
     not be construed to prejudice the Committee on Government 
     Reform's jurisdictional interest and prerogatives on this 
     bill or any other similar legislation and will not be 
     considered as precedent for consideration of matters of 
     jurisdictional interest to my Committee in the future.
       I respectfully request your support for the appointment of 
     outside conferees from the Committee on Government Reform 
     should this bill or a similar bill be considered in a 
     conference with the Senate. Finally, I request that you 
     include this letter and your response in the Congressional 
     Record during consideration of the legislation on the House 
     floor.
       Thank you for your attention to these matters.
           Sincerely,
                                                        Tom Davis.

  Mr. WAXMAN. Mr. Speaker, the bill before us would create a new agency 
within the Department of Health and Human Services, the Biomedical 
Advanced Research and Development Authority, or BARDA. I support 
creating this new agency. However, some provisions in the bill raise 
concerns because they waive a number of existing Federal statutes 
enacted to ensure proper government oversight. I want to express my 
reservations over these provisions, and urge that they be addressed in 
conference.
  This bill contains exemptions from important federal open government 
laws designed to ensure accountability and transparency, like the 
Freedom of Information Act (FOIA) and federal procurement law. These 
open government laws are within the jurisdiction of the Committee on 
Government Reform, on which I am the ranking member, but unfortunately, 
the Government Reform Committee did not have an opportunity to consider 
the bill.
  FOIA is the central law that guarantees public access to government 
information. It establishes the presumption that people should be able 
to access information held by the government. FOIA contains exemptions 
that prevent the disclosure of information in the case where harm could 
result from disclosure--including exemptions for classified 
information, trade secrets, information compiled for law enforcement 
purposes, and internal agency documents that would be exempt from 
discovery in litigation.
  H.R. 5533 establishes a new FOIA exemption, requiring the Secretary 
to withhold from public disclosure ``specific technical data of 
scientific information that is created or obtained during 
countermeasure research and product advanced development funded by the 
Secretary that reveal vulnerabilities of existing medical or public 
health defenses against biological, chemical, nuclear, or radiological 
threats.'' While this exemption appears narrow in scope, the 
Administration has a long record of interpreting narrow language 
broadly to withhold public information. Unless there is a compelling 
reason why the existing FOIA exemptions are inadequate--which there 
does not appear to be in this case--it is unwise to add new exemptions 
to FOIA. Moreover, the language of the new exemption is not clear. The 
language applies to any ``advanced research and development that is 
funded by the Secretary,'' which may inappropriately extend the 
exemption far beyond BARDA to other research funded by the Department 
of Health and Human Services.
  Another issue is so-called ``other transaction authority.'' This 
authority is essentially a waiver from most federal procurement law--
everything from competition requirements, to auditing and pricing 
safeguards, to the Buy America and Drug-free workplace laws. The 
authority was originally developed to help DOD in attracting smaller 
contractors to federal research and development contracts, though in 
practice it has not often been used to accomplish that objective. While 
I am not necessarily opposed to granting BARDA other transaction 
authority, I have yet to hear a convincing rationale for its necessity. 
If such a rationale exists, we should explore ways to limit its 
application at BARDA to those instances where it is truly needed, as 
opposed to the blanket grant of authority currently in H.R. 5533.
  Finally, H.R. 5533 exempts all advisory committees established under 
the bill from section 14 of the Federal Advisory Committee Act. Section 
14 was added to the FACA law because Congress decided that there was a 
proliferation of advisory committees and that it is important to ensure 
that they should continuously be reviewed to ensure their ongoing 
necessity. Again, there is no clear explanation for why this waiver of 
current law is necessary, or what interests would be protected by 
exempting the committees from renewal requirements.
  All of these issues are within the jurisdiction of the Government 
Reform Committee, and I hope they can be addressed as this bill moves 
forward in the legislative process.
  Mr. GENE GREEN of Texas. Mr. Speaker, I rise in support of H.R. 5533, 
to advance the development of biological countermeasures.
  The anthrax attacks of 2001 shined a bright light on our lack of 
preparedness to deal with a biological attack. While we were blessed 
that Cipro was an effective countermeasure for anthrax specifically, 
the attacks led us to realize the real possibility that our enemies 
could develop the capability to attack our country using several 
biological agents for which we do not have effective countermeasures.
  This possibility strikes great fear in most Americans, who have been 
bombarded in recent years with the threat not only of bioterrorism but 
also pandemic flu. However, this uncertainty of a biological attack or 
pandemic flu is the same factor that often keeps manufacturers from 
making the investments necessary to bring a countermeasure to market.
  When medical treatments for conditions such as high blood pressure 
and high cholesterol are developed, pharmaceutical manufacturers are 
willing to make the investment in research and development because 
there is a known demand for these treatments. We are lucky that there 
is no current demand for biological countermeasures. As a country 
responsible for protecting American citizens, however, we cannot wait 
for a biological attack or pandemic flu to occur before these 
countermeasures are developed.
  This is a classic case of market failure, where the government must 
intervene and provide public resources to ensure that we have effective 
countermeasures before a biological attack occurs. This bill achieves 
that goal by providing the incentives to encourage the private sector 
to develop these treatments. Specifically, it would provide the 
necessary assurances that the federal government will purchase the end 
product for use in the event of an attack. Additionally, it will 
provide milestone payments to countermeasure developers to bridge the 
funding gap between basic research and countermeasure development.
  I encourage my colleagues to join me in supporting this bill, which 
will go a long way toward ensuring that we have effective biological 
countermeasures in place in the event of a biological attack or 
infectious disease pandemic.
  Ms. ESHOO. Mr. Speaker, I yield back the balance of my time.
  Mr. DEAL of Georgia. Mr. Speaker, I have no other requests for time, 
and I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Georgia (Mr. Deal) that the House suspend the rules and 
pass the bill, H.R. 5533, as amended.
  The question was taken; and (two-thirds having voted in favor 
thereof) the rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

[[Page 19868]]



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