H.R. 5533House109th Congress (2005-2007)Passed House

Biodefense and Pandemic Vaccine and Drug Development Act of 2006

Legislative Activity

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14 earlier actions

SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

November 13, 2006

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HouseIntro Referral

Introduced in House

June 6, 2006

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

June 6, 2006

HouseCommittee

Referred to the Subcommittee on Health.

Health Subcommittee

June 23, 2006

HouseCommittee

Committee Consideration and Mark-up Session Held.

Energy and Commerce Committee

September 20, 2006

HouseCommittee

Ordered to be Reported (Amended) by Voice Vote.

Energy and Commerce Committee

September 20, 2006

HouseCommittee

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 109-686.

Energy and Commerce Committee

September 26, 2006

HouseCalendars

Placed on the Union Calendar, Calendar No. 416.

September 26, 2006

HouseFloor

Mr. Deal (GA) moved to suspend the rules and pass the bill, as amended.

September 26, 2006 • 7:47 PM

HouseFloor

Considered under suspension of the rules. (consideration: CR H7445-7450)

September 26, 2006 • 7:47 PM

HouseFloor

DEBATE - The House proceeded with forty mintues of debate on H.R. 5533.

September 26, 2006 • 7:47 PM

HouseFloor

Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H7445-7447)

September 26, 2006 • 8:01 PM

HouseFloor

On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H7445-7447)

September 26, 2006 • 8:01 PM

HouseFloor

Motion to reconsider laid on the table Agreed to without objection.

September 26, 2006 • 8:01 PM

SenateIntro Referral

Received in the Senate.

September 27, 2006

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

November 13, 2006

Floor Debate

7 members

What members said about H.R. 5533 on the floor

3 Republicans4 Democrats

Rep. Mike RogersR-MI-8 · Sep 26, 2006

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…

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.

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.

Rep. Anna G. EshooD-CA-14 · Sep 26, 2006

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…

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. 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. Speaker, I yield back the balance of my time.

Rep. Henry A. WaxmanD-CA-30 · Sep 26, 2006

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.

Rep. Nathan DealR-GA-10 · Sep 26, 2006

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,…

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.

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.

Mr. Speaker, I am pleased to yield 5 minutes to the gentleman from Michigan (Mr. Rogers), the author of the legislation.

Mr. Speaker, I have no other requests for time, and I yield back the balance of my time.

Rep. Anna G. EshooD-CA-14 · Dec 8, 2006

Mr. Speaker, as the Democratic sponsor of the House version of this bill, H.R. 5533, I am proud to rise today in strong support of this legislation. This bill addresses an urgent issue which is…

Mr. Speaker, as the Democratic sponsor of the House version of this bill, H.R. 5533, I am proud to rise today in strong support of this legislation. This bill addresses an urgent issue which is critical to our Nation's security and public health: The threat of bioterror and pandemic disease.

Last week the State Department issued a warning that the continuing spread of a highly contagious avian influenza (H5N1) virus among animals in Asia, Africa, the Middle East and Europe has the potential to significantly threaten human health. The virus has already caused nearly 150 human deaths around the world. If a virus such as H5N1 mutates and spreads easily from one person to another, avian influenza could break out globally. While there are no reports of sustained human-to-human transmission of avian influenza, the U.S. government and international health agencies are scrambling to prepare for a possible pandemic.

In hearings earlier this year on the Project Bioshield Act, it was apparent that gaps remain in our effort to address emerging threats

to public health. In particular, we learned that very few companies are willing to risk their limited resources to develop the vaccines and antidotes to respond to chemical, biological, radiological or nuclear attacks or to a fast-spreading influenza such as H5N1. Put simply, there is little economic incentive for companies to conduct the vital research necessary in this field.

The centerpiece of our legislation is a new office within HHS, the Biomedical Advanced Research and Development Authority (BARDA), which will be a single point of federal authority for the development of medical countermeasures.

The bill enables the Secretary of HHS and the BARDA Director to collaborate and consult with agency leaders, academia, and industry on developing needed medical countermeasures and pandemic or epidemic products. This bill also empowers BARDA to make milestone payments to drug developers at key stages of their work, helping to reduce the financial risks of taking on such a great challenge.

This legislation has broad bipartisan support in the House of Representatives and the Senate, and I thank the bill's many cosponsors for their support. I especially want to thank Congressman Mike Rogers for his leadership on this issue. This bill demonstrates the good that can come out of bipartisan teamwork and I'm proud to have worked with him to make this bill a reality.

I also want to thank Chairmen Barton and Deal as well as Ranking Member Dingell for acknowledging the importance of this legislation and working with us every step of the way to get it done before the end of the year.

I also want to thank the staff members who have put so much time and energy into this legislation: Kelly Childress with Representative Rogers, Nandan Kenkeremath with Chairman Barton, Brandon Clark with Chairman Deal, John Ford with Representative Dingell, and Jason Mahler and Jennifer Nieto of my staff.

Mr. Speaker, this is a good bill that ensures our country is doing its best to prepare for the worst. Thank you for bringing this bill before the House today and I urge my colleagues to support it.

The Senate bill was ordered to be read a third time, was read the third time, and passed, and a motion to reconsider was laid on the table.

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Rep. John D. DingellD-MI-15 · Sep 26, 2006

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…

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.

Rep. Joe BartonR-TX-6 · Dec 8, 2006

Mr. Speaker, I ask unanimous consent to take from the Speaker's table the Senate bill (S. 3678) to amend the Public Health Service Act with respect to public health security and all- hazards…

Mr. Speaker, I ask unanimous consent to take from the Speaker's table the Senate bill (S. 3678) to amend the Public Health Service Act with respect to public health security and all- hazards preparedness and response, and for other purposes, and ask for its immediate consideration in the House.

Mr. Speaker, please insert this exchange of correspondence on S. 3678 into the Record.

Congress of the United States,

House of Representatives,

Washington, DC, December 8, 2006.

Hon. J. Dennis Hastert,

Speaker, House of Representatives, Washington, DC.

Dear Mr. Speaker: We write to clarify the intent of Title I

of S. 3678, the ``Pandemic and All-Hazards Preparedness

Act,'' regarding the respective roles and responsibilities of

the Secretary of Homeland Security and the Secretary of

Health and Human Services during Incidents of National

Significance under the National Response Plan (NRP). Title I

of S. 3678 should not be construed to designate the

Department of Health and Human Services as the lead Federal

agency under the NRP during incidents of National

Significance that require a medical and/or public health

response.

The NRP is an all-discipline, all-hazards plan that

establishes a single, comprehensive framework for the

management of domestic incidents. Under the NRP, the

Department of Homeland Security (DHS) is the Federal

department responsible for coordinating Federal operations

and/or resources during Incidents of National Significance,

while the Department of Health and Human Services (DHHS) is

the Federal coordinator and primary agency for Emergency

Support Function 8, Public Health and Medical Services.

Nothing in Title I should be interpreted to change or affect

the existing relationship between DHS as the incident manager

and DHHS as the primary agency for medical services, as

currently defined by the NRP for Incidents of National

Significance.

Rather than amending or otherwise diminishing the existing

responsibilities of the Secretary of Homeland Security under

the NRP, S. 3678 is intended to clarify and more specifically

define the medical preparedness and response authorities of

the Secretary of Health and Human Services with respect to

the Public Health Service Act.

A copy of this letter will be included in the Record during

consideration of the bill on the House floor and should be

construed as a definitive expression of Congressional intent

on this matter.

Sincerely,

Peter T. King,

Chairman, Committee on Homeland Security.

Joe Barton,

Chairman, Committee on Energy and Commerce.

Rep. Gene GreenD-TX-29 · Sep 28, 2006

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…

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.

Rep. Joe BartonR-TX-6 · Sep 26, 2006

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…

Bill Text

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Referred in SenateIssued November 13, 2006

        [Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5533 Referred in Senate (RFS)]

2d Session
H. R. 5533

_______________________________________________________________________

IN THE SENATE OF THE UNITED STATES

September 27, 2006

Received

November 13, 2006

Read twice and referred to the Committee on Health, Education, Labor,
and Pensions

_______________________________________________________________________

AN ACT

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

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

SECTION 1. SHORT TITLE.

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

SEC. 2. TABLE OF CONTENTS.

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

SEC. 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.
``(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
``(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
``(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.''

Passed the House of Representatives September 26, 2006.

Attest:

KAREN L. HAAS,

Clerk.