Biodefense and Pandemic Vaccine and Drug Development Act of 2006
Latest action · Nov 13, 2006 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedJun 6, 2006
- Passed HouseSep 26, 2006
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Biodefense and Pandemic Vaccine and Drug Development Act of 2006 - Amends the Public Health Service Act to establish the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (HHS). Requires the Secretary of Health and Human Services to coordinate and oversee the acceleration of countermeasure and product advanced research and development.
Requires the Secretary to: (1) facilitate and increase expeditious and direct communication with respect to such research and development; (2) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products; (3) direct and coordinate such research and development activities of HHS; (4) establish strategic initiatives to accelerate such research and development and innovation in priority unmet need areas; and (5) connect interested persons with authorized offices or employees to advise such persons regarding relevant regulatory requirements related to qualified countermeasures or qualified pandemic or epidemic products. Allows the Secretary to award contracts, grants, and cooperative agreements or enter into other transactions to promote: (1) innovation in technologies that may assist such research and development; (2) research on and development of research tools and other devices and technologies; and (3) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies.
Authorizes the Secretary to enter into other transactions for countermeasure and product advanced research and development. Gives the Secretary expedited procurement authorities, the authority to expedite peer review, and the authority for personal services contracts. Authorizes the Secretary to require that, as a condition of being awarded a contract, grant, cooperative agreement, or other transaction, a person make available to the Secretary relevant data related to or resulting from such research and development. Exempts the Secretary's authority to enter into contracts from advertising and advance payment requirements.
Allows the Secretary to: (1) use milestone-based awards and payments; (2) make awards to and enter into transactions with highly qualified foreign national persons outside the United States under certain circumstances; (3) establish one or more federally-funded research and development centers or university-affiliated research centers; (4) 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; (5) appoint highly qualified individuals to scientific or professional positions in BARDA without regard to federal provisions governing appointments in the competitive service; (6) appoint special consultants; and (7) accept voluntary and uncompensated services.
Requires the Secretary to withhold from disclosure under the Freedom of Information Act 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 reveals vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats.
Authorizes appropriations for FY2007-FY2008.
Requires the Secretary to establish the National Biodefense Science Board to provide expert advice and guidance to the Secretary on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents.
(Sec. 4) Includes within the definitions of "qualified countermeasure" and "security countermeasure" an agent to diagnose, mitigate, prevent, or treat harm from organisms that cause an infectious disease. Deems as a qualified countermeasure without further administrative action any countermeasure for a biological agent if the Secretary determines that there is credible evidence that such agent has the potential to cause an epidemic or pandemic that may constitute a public health emergency.
(Sec. 5) Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to establish within the Food and Drug Administration (FDA) a team of experts on manufacturing and regulatory activities to provide technical assistance to the manufacturers of qualified countermeasures, security countermeasures, or vaccines if the Secretary determines that a shortage or potential shortage may occur.
(Sec, 6) Allows partial payment on a procurement contract for a security countermeasure for significant milestones or a payment to increase manufacturing capacity. Allows procurement contracts to provide: (1) for advance payments for milestones; (2) that the vendor is the sole and exclusive supplier of the product to the government for a specified period if the vendor is able to satisfy the government's needs; (3) that the vendor establish domestic manufacturing capacity of the product to ensure that additional production is available as necessary; (4) dosing and administration requirements for countermeasures; (5) the amount of funding that will be dedicated by the Secretary for countermeasure research and development; and (6) specifications the countermeasure must meet to qualify for procurement under a contract.
Cosponsors 11
Members who signed on, in the order they did. Signatures ran from Jun 6, 2006 to Sep 19, 2006; 3 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-CA | Anna G. Eshoo | Original | Jun 6, 2006 |
| R-NY | John M. McHugh | Original | Jun 6, 2006 |
| R-MI | Peter Hoekstra | Original | Jun 6, 2006 |
| R-TX | Michael C. Burgess | Jun 7, 2006 | |
| D-LA | William J. Jefferson | Jun 15, 2006 | |
| D-SC | James E. Clyburn | Jun 19, 2006 | |
| D-CA | Lois Capps | Jul 17, 2006 | |
| D-TN | Bart Gordon | Jul 28, 2006 | |
| R-IL | John Shimkus | Sep 6, 2006 | |
| R-NJ | Mike Ferguson | Sep 6, 2006 | |
| D-MD | Albert Russell Wynn | Sep 19, 2006 |
Committees 2
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Jun 6, 2006Markup Sep 20, 2006Reported Sep 26, 2006 |
| Health Subcommittee | Referred Jun 23, 2006 | |
| Senate | Health, Education, Labor, and Pensions Committee | Referred Nov 13, 2006 |
Actions 14
Everything that happened, newest first.
- Nov 13, 2006Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Sep 27, 2006Received in the Senate.
- Sep 26, 2006Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 109-686.
- Sep 26, 2006Placed on the Union Calendar, Calendar No. 416.
- Sep 26, 2006Mr. Deal (GA) moved to suspend the rules and pass the bill, as amended.
- Sep 26, 2006Considered under suspension of the rules. (consideration: CR H7445-7450)
- Sep 26, 2006DEBATE - The House proceeded with forty mintues of debate on H.R. 5533.
- Sep 26, 2006Passed/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)
- Sep 26, 2006Motion to reconsider laid on the table Agreed to without objection.
- Sep 20, 2006Committee Consideration and Mark-up Session Held.
- Sep 20, 2006Ordered to be Reported (Amended) by Voice Vote.
- Jun 23, 2006Referred to the Subcommittee on Health.
- Jun 6, 2006Introduced in House
- Jun 6, 2006Referred to the House Committee on Energy and Commerce.
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Committee report
Congressional Budget Office cost estimates 2
- Sep 26, 2006H.R. 5533, Biodefense and Pandemic Vaccine and Drug Development Act of 2006<p>Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on September 20, 2006</p>
- Sep 26, 2006H.R. 5533, Biodefense and Pandemic Vaccine and Drug Development Act of 2006Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on September 20, 2006
CRS reports 1
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 1
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| RL33589 | The Pandemic and All-Hazards Preparedness Act (P.L. 109-417): Provisions and Changes to Preexisting Law Archived | Report | Mar 12, 2007 |
Related bills 2
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 1873 | Biodefense and Pandemic Vaccine and Drug Development Act of 2005 | Related bill | Oct 24, 2005 |
| S 2564 | Biodefense and Pandemic Vaccine and Drug Development Act of 2006 | Related bill | Apr 6, 2006 |
Titles 4
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To prepare and strengthen the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness, and for other purposes.
- Short Titles as Introduced
- Biodefense and Pandemic Vaccine and Drug Development Act of 2006
- Short Titles as Reported to House
- Biodefense and Pandemic Vaccine and Drug Development Act of 2006
- Short Titles as Passed House
- Biodefense and Pandemic Vaccine and Drug Development Act of 2006
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Access to health care
- Antibiotics
- Antitrust law
- Awards, medals, prizes
- Biological warfare
- Chemical warfare
- Commemorations
- Commerce
- Communicable diseases
- Communication in medicine
- Communication in science
- Conferences
- Congressional reporting requirements
- Department of Health and Human Services
- Drug industry
- Economics and Public Finance
- Epidemics
- Executive reorganization
- Federal advisory bodies
- Federal aid to research
- Government Operations and Politics
- Government procurement
- Government trust funds
- Health
- Health planning
- Laboratories
- Medical technology
- Medical tests
- Nuclear terrorism
- Pharmaceutical research
- Radiation victims
- Research and development
- Research and development facilities
- Research centers
- Research grants
- Science, Technology, Communications
- Strategic planning
- Technological innovations
- Terrorism
- Vaccines
Text 4
Each version as it was printed, newest first.
- Nov 13, 2006Referred in Senate
- Sep 26, 2006Engrossed in House
- Sep 26, 2006Reported in House
- Jun 6, 2006Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.