109 HR 5533 IH: Biodefense and Pandemic U.S. House of Representatives 2006-06-06 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 109th CONGRESS 2d Session H. R. 5533 IN THE HOUSE OF REPRESENTATIVES June 6, 2006 Mr. Rogers of Michigan (for himself, Ms. Eshoo, Mr. Hoekstra, and Mr. McHugh) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To prepare and strengthen the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness, and for other purposes.

1.

Short title

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

2.

Table of contents

The table of contents of this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Sec. 3. Biomedical Advanced Research and Development Authority; National Biodefense Science Board. Sec. 4. Clarification of countermeasures covered by Project BioShield. Sec. 5. Technical assistance. Sec. 6. Procurement. Sec. 7. Rule of construction.

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:

319L.

Biomedical Advanced Research and Development Authority

(a)

Definitions

In this section: (1)

BARDA

The term BARDA means the Biomedical Advanced Research and Development Authority. (2)

Fund

The term Fund means the Biodefense Medical Countermeasure Development Fund established under subsection (d). (3)

Other transactions

The term other transactions means transactions, other than procurement contracts, grants, and cooperative agreements, such as the Secretary of Defense may enter into under section 2371 of title 10, United States Code. (4)

Qualified countermeasure

The term qualified countermeasure has the meaning given such term in section 319F–1. (5)

Qualified pandemic or epidemic product

The term qualified pandemic or epidemic product has the meaning given the term in section 319F–3. (6)

Advanced research and development

(A)

In general

The term advanced research and development means, with respect to a product that is or may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly— (i)are conducted after basic research and preclinical development of the product; and (ii)are related to manufacturing the product on a commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act. (B)

Activities included

The term under subparagraph (A) includes— (i)testing of the product to determine whether the product may be approved, cleared, or licensed under the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act for a use that is or may be the basis for such product becoming a qualified countermeasure or qualified pandemic or epidemic product, or to help obtain such approval, clearance, or license; (ii)design and development of tests or models, including animal models, for such testing; (iii)activities to facilitate manufacture of the product on a commercial scale with consistently high quality, as well as to improve and make available new technologies to increase manufacturing surge capacity; (iv)activities to improve the shelf-life of the product or technologies for administering the product; and (v)such other activities as are part of the advanced stages of testing, refinement, improvement, or preparation of the product for such use and as are specified by the Secretary. (7)

Research tool

The term research tool means a device, technology, biological material (including a cell line or an antibody), reagent, animal model, computer system, computer software, or analytical technique that is developed to assist in the discovery, development, or manufacture of qualified countermeasures or qualified pandemic or epidemic products. (8)

Program manager

The term program manager means an individual appointed to carry out functions under this section and authorized to provide project oversight and management of strategic initiatives. (9)

Person

The term person includes an individual, partnership, corporation, association, entity, or public or private corporation, and a Federal, State, or local government agency or department. (b)

Strategic plan for countermeasure research, development, and procurement

(1)

In general

Not later than 6 months after the date of enactment of the Biodefense and Pandemic Vaccine and Drug Development Act of 2006, the Secretary shall develop, make public, and present to the appropriate Congressional committees a strategic plan to integrate biodefense and emerging infectious disease requirements with the advanced research and development, strategic initiatives for innovation, and the procurement of qualified countermeasures and qualified pandemic or epidemic products. The Secretary shall periodically review and, as appropriate, revise the plan. (2)

Content

The strategic plan under paragraph (1) shall— (A)guide research and development, conducted or supported by the Department of Health and Human Services, of qualified countermeasures and qualified pandemic or epidemic products against possible biological, chemical, radiological, and nuclear agents and to emerging infectious diseases; (B)guide innovation in technologies that may assist advanced research and development of qualified countermeasures and qualified pandemic or epidemic products (such research and development referred to in this section as countermeasure and product advanced research and development); (C)guide procurement of such qualified countermeasures and qualified pandemic or epidemic products by such Department; (D)include immediate, short-term, and long-term goals; (E)include immediate, short-term, and long-term procurement priorities; and (F)identify processes used to designate a range of funds available for various types of countermeasure procurements. (c)

Biomedical Advanced Research and Development Authority

(1)

Establishment

There is established within the Department of Health and Human Services the Biomedical Advanced Research and Development Authority. (2)

In general

Based upon the strategic plan described in subsection (b), the Secretary shall coordinate and oversee the acceleration of countermeasure and product advanced research and development by— (A)facilitating collaboration among the Department of Health and Human Services, other Federal agencies, relevant industries, academia, and other persons, with respect to such advanced research and development; (B)promoting countermeasure and product advanced research and development; (C)facilitating contacts between interested persons and the offices or employees authorized by the Secretary to advise such persons regarding requirements under the Federal Food, Drug, and Cosmetic Act and under section 351 of this Act; and (D)promoting innovation to reduce the time and cost of countermeasure and product advanced research and development. (3)

Director

The BARDA shall be headed by a Director (referred to in this section as the Director) who shall be appointed by the Secretary and to whom the Secretary shall delegate such functions and authorities as necessary to implement this section. (4)

Duties

(A)

Collaboration

To carry out the purpose described in paragraph (2)(A), the Secretary shall— (i)facilitate and increase the expeditious and direct communication between the Department of Health and Human Services and relevant persons with respect to countermeasure and product advanced research and development, including by— (I)facilitating such communication regarding the processes for procuring such advanced research and development with respect to qualified countermeasures and qualified pandemic or epidemic products of interest; and (II)soliciting information about and data from research on potential qualified countermeasures and qualified pandemic or epidemic products and related technologies; (ii)at least annually— (I)convene meetings with representatives from relevant industries, academia, other Federal agencies, international agencies as appropriate, and other interested persons; (II)sponsor opportunities to demonstrate the operation and effectiveness of relevant biodefense countermeasure technologies; and (III)convene such working groups on countermeasure and product advanced research and development as the Secretary may determine are necessary to carry out this section; and (iii)carry out the activities described in section 7 of the Biodefense and Pandemic Vaccine and Drug Development Act of 2006. (B)

Support advanced research and development

To carry out the purpose described in paragraph (2)(B), the Secretary shall— (i)conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products; (ii)direct and coordinate the countermeasure and product advanced research and development activities of the Department of Health and Human Services; (iii)establish strategic initiatives to accelerate countermeasure and product advanced research and development and innovation in such areas as the Secretary may identify as priority unmet need areas; and (iv)award contracts, grants, cooperative agreements, and enter into other transactions, for countermeasure and product advanced research and development. (C)

Facilitating advice

To carry out the purpose described in paragraph (2)(C) the Secretary shall— (i)connect interested persons with the offices or employees authorized by the Secretary to advise such persons regarding the regulatory requirements under the Federal Food, Drug, and Cosmetic Act and under section 351 of this Act related to the approval, clearance, or licensure of qualified countermeasures or qualified pandemic or epidemic products; and (ii)ensure that, with respect to persons performing countermeasure and product advanced research and development funded under this section, such offices or employees provide such advice in a manner that is ongoing and that is otherwise designated to facilitate expeditious development of qualified countermeasures and qualified pandemic or epidemic products that may achieve such approval, clearance, or licensure. (D)

Supporting innovation

To carry out the purpose described in paragraph (2)(D), the Secretary may award contracts, grants, and cooperative agreements, or enter into other transactions, such as prize payments, to promote— (i)innovation in technologies that may assist countermeasure and product advanced research and development; (ii)research on and development of research tools and other devices and technologies; and (iii)research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies. (5)

Transaction authorities

(A)

Other transactions

In carrying out the functions under subparagraph (B) or (D) of paragraph (4), the Secretary shall have authority to enter into other transactions for countermeasure and product advanced research and development. (B)

Expedited authorities

(i)

In general

In awarding contracts, grants, and cooperative agreements, and in entering into other transactions under subparagraph (B) or (D) of paragraph (4), the Secretary shall have the expedited procurement authorities, the authority to expedite peer review, and the authority for personal services contracts, supplied by subsections (b), (c), and (d) of section 319F–1. (ii)

Application of provisions

Provisions in such section 319F–1 that apply to such authorities and that require institution of internal controls, limit review, provide for Federal Tort Claims Act coverage of personal services contractors, and commit decisions to the discretion of the Secretary shall apply to the authorities as exercised pursuant to this paragraph. (iii)

Authority to limit competition

For purposes of applying section 319F–1(b)(1)(D) to this paragraph, the phrase BioShield Program under the Project BioShield Act of 2004 shall be deemed to mean the countermeasure and product advanced research and development program under this section. (iv)

Availability of data

The Secretary shall require that, as a condition of being awarded a contract, grant, cooperative agreement, or other transaction under subparagraph (B) or (D) of paragraph (4), a person make available to the Secretary on an ongoing basis, and submit upon request to the Secretary, all data related to or resulting from countermeasure and product advanced research and development carried out pursuant to this section. (C)

Advance payments; advertising

The authority of the Secretary to enter into contracts under this section shall not be limited by section 3324(a) of title 31, United States Code, or by section 3709 of the Revised Statutes of the United States (41 U.S.C. 5). (D)

Milestone-based payments allowed

In awarding contracts, grants, and cooperative agreements, and in entering into other transactions, under this section, the Secretary may use milestone-based awards and payments. (E)

Foreign nationals eligible

The Secretary may under this section award contracts, grants, and cooperative agreements to, and may enter into other transactions with, highly qualified foreign national persons outside the United States, alone or in collaboration with American participants, when such transactions may inure to the benefit of the American people. (F)

Establishment of research centers

The Secretary may establish one or more federally-funded research and development centers, or university-affiliated research centers in accordance with section 303(c)(3) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(3)), provided that such centers are consistent and complementary with the duties described in paragraph (4), and are consistent and complementary with, and deemed necessary after considering the availability of, existing federally-supported basic research programs. (6)

Vulnerable populations

In carrying out the functions under this section, the Secretary may give priority to the advanced research and development of qualified countermeasures and qualified pandemic or epidemic products that are likely to be safe and effective with respect to children, pregnant women, and other vulnerable populations. (7)

Personnel authorities

(A)

Specially qualified scientific and professional personnel

In addition to any other personnel authorities, the Secretary may— (i)without regard to those provisions of title 5, United States Code, governing appointments in the competitive service, appoint highly qualified individuals to scientific or professional positions in BARDA, such as program managers, to carry out this section; and (ii)compensate them in the same manner in which individuals appointed under section 9903 of such title are compensated, without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates. (B)

Special consultants

In carrying out this section, the Secretary may— (i)appoint special consultants pursuant to section 207(f); and (ii)accept voluntary and uncompensated services. (d)

Fund

(1)

Establishment

There is established the Biodefense Medical Countermeasure Development Fund, which shall be available to carry out this section in addition to such amounts as are otherwise available for this purpose. (2)

Funding

To carry out the purposes of this section, there are authorized to be appropriated to the Fund— (A)$1,070,000,000 for fiscal years 2006 through 2008, the amounts to remain available until expended; and (B)such sums as may be necessary for subsequent fiscal years, the amounts to remain available until expended. (e)

Inapplicability of Certain Provisions

(1)

Disclosure

(A)

In general

The Secretary shall withhold from disclosure under section 552 of title 5, United States Code, specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development funded by the Secretary that reveal vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats. Such information shall be deemed to be information described in section 552(b)(3) of title 5, United States Code. (B)

Oversight

Information subject to nondisclosure under subparagraph (A) shall be reviewed by the Secretary every 5 years to determine the relevance or necessity of continued nondisclosure. (2)

Federal Advisory Committee Act

Section 14 of the Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to a working group of BARDA or to the National Biodefense Science Board under section 319M.

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.

.

4.

Clarification of countermeasures covered by Project BioShield

(a)

Qualified Countermeasure

Section 319F–1(a) of the Public Health Service Act (42 U.S.C. 247d–6a(a)) is amended by striking paragraph (2) and inserting the following: (2)

Definitions

In this section: (A)

Qualified countermeasure

The term qualified countermeasure means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that the Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of the Homeland Security Act of 2002) to— (i)diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security; or (ii)diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in this subparagraph. (B)

Infectious disease

The term infectious disease means a disease potentially caused by a pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a person and that reproduces in that person. . (b)

Security Countermeasure

Section 319F–2(c)(1)(B)(i)(I) is amended by striking to treat the first place such term appears and all that follows through from a condition and inserting the following: to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent identified as a material threat under paragraph (2)(A)(ii), or to diagnose, mitigate, prevent, or treat harm from a condition.

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:

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.

.

6.

Procurement

(a)

Security countermeasures

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

Payment conditioned on delivery

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

Procurement of multiple products and technologies

Notwithstanding any other provision of law or regulation, the Secretary shall, where possible, enter into multiple transactions for the procurement of multiple technologies and products from multiple manufacturers of security countermeasures in order to mitigate against the risks associated with dependence on a single supplier or technology. (VIII)

Sales exclusivity

The contract may provide that the vendor is the exclusive supplier of the product to the Federal Government for a specified period of time, not to exceed the term of the contract, on the condition that the vendor is able to satisfy the needs of the Government. During the agreed period of sales exclusivity, the vendor shall not assign its rights of sales exclusivity to another entity or entities without approval by the Secretary. Such a sales exclusivity provision in such a contract shall constitute a valid basis for a sole source procurement under section 303(c)(1) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)). (IX)

Surge capacity

The contract may provide that the vendor establish domestic manufacturing capacity of the product to ensure that additional production of the product is available in the event that the Secretary determines that there is a need to quickly purchase additional quantities of the product. Such contract may provide a fee to the vendor for establishing and maintaining such capacity in excess of the initial requirement for the purchase of the product. Additionally, the cost of maintaining the domestic manufacturing capacity shall be an allowable and allocable direct cost of the contract. (X)

Additional contract terms

The Secretary, in any contract for procurement under this section, may specify— (aa)the dosing and administration requirements for countermeasures to be developed and procured; (bb)the amount of funding that will be dedicated by the Secretary for development and acquisition of the countermeasure; and (cc)the specifications the countermeasure must meet to qualify for procurement under a contract under this section. ; and (E)in paragraph (8)(A), by adding at the end the following: Such agreements may allow other executive agencies to order qualified and security countermeasures under procurement contracts or other agreements established by the Secretary. Such ordering process (including transfers of appropriated funds between an agency and the Department of Health and Human Services as reimbursements for such orders for countermeasures) may be conducted under the authority of section 1535 of title 31, United States Code, except that all such orders shall be processed under the terms established under this section for the procurement of countermeasures.. (b)

Qualified countermeasures

Section 319F–1(b) of the Public Health Service Act (42 U.S.C. 247d–6a(b)) is amended by adding at the end the following: (5)

Procurement of multiple products and technologies

Notwithstanding any other provision of law or regulation, the Secretary shall, where possible, enter into multiple transactions for the procurement of multiple technologies and products from multiple manufacturers of qualified countermeasures in order to mitigate against the risks associated with dependence on a single supplier or technology. .

7.

Rule of construction

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