Dental Emergency Responder Act of 2011

Madam Speaker, I'd like to yield such time as she may consume to the gentlewoman from California (Ms. Eshoo) and stress her involvement in this issue over the years.

Madam Speaker, I yield myself such time as I may consume.

I'm pleased to rise in support of H.R. 6672, the Pandemic and All- Hazards Preparedness Reauthorization Act of 2012. This bill reflects bipartisan work that has taken place between the House and Senate over the last several months to resolve differences between the House and Senate-passed PAHPA reauthorization bills.

We all know very well that our Nation continues to face threats that require an ongoing commitment to public health and emergency preparedness. Just recently we experienced a devastating storm along the east coast--Hurricane Sandy--that destroyed entire communities in coastal New Jersey and New York, including areas within my district. The Federal Government's support, including through programs authorized by PAHPA, was critical in the wake of this disaster.

The legislation before us today reauthorizes programs and activities first established as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the 2004 Project Bioshield Act, and the 2006 Pandemic and All-Hazards Preparedness.

In the wake of 9/11, Congress placed a high priority on biodefense. Congress first passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to improve the Nation's ability to respond to acts of biological terrorism.

In 2004, we passed the Project Bioshield Act with tremendous bipartisan support, and Democrats and Republicans worked together to authorize the development, procurement, and emergency use of medical countermeasures for biological, chemical, radiological, and nuclear threats.

We then identified some shortfalls, and in 2006 worked to amend and build upon the existing BioShield program and Department of Health and Human Services authorities by passing PAHPA. For example, PAHPA charged the Assistant Secretary for Preparedness and Response with the Department's public health and medical response. It required, a National Health Security Strategy to guide the Department's preparedness and response efforts, reauthorize grants to improve State and local public health and hospital preparedness, and establish the Biomedical Advance Research and Development Authority to spur development of medical countermeasures.

Together, BioShield and PAHPA represent more comprehensive efforts to prepare for and respond to public health emergencies, whether they're naturally occurring events like the H1N1 outbreak, or those that are deliberate, such as anthrax attacks. As a result of these bills and the investments that followed, our Nation is better equipped to respond to public health emergencies.

I'd just like to take a few moments, Madam Speaker, to highlight ways that H.R. 6672 will continue the progress we've made over the past decade.

First, the bill further facilitates the development of medical countermeasures through emphasizing medical countermeasures advancement in the National Health Security Strategy; requiring the development of a 5-year budget analysis of the countermeasure enterprise; and calling for the development of a countermeasure strategy and implementation plan.

Second, Madam Speaker, H.R. 6672 bolsters the Nation's medical and public health preparedness and response infrastructure, including through a new authority that would allow States to redeploy personnel funded through Federal programs to the areas within their State where they're most needed in the aftermath of a disaster.

Third, it strengthens and clarifies the position of Assistant Secretary for

Preparedness and Response as the lead for HHS on emergency preparedness and response and calls for streamlining and better coordinating HHS preparedness grants with those of other departments.

Next, it places even greater emphasis on the special needs of pediatric and other at-risk populations in preparing for and responding to public health emergencies.

Finally, H.R. 6672 improves FDA's emergency response capabilities. It will enable FDA to authorize the distribution and use of medical countermeasures in preparation for an emergency and to take actions during an emergency that will allow for the most effective use of medical countermeasures.

I'd like to thank Congressman Mike Rogers, Congressman Gene Green, and their staff who authored the original House legislation, H.R. 2405. I'd like to recognize the contributions of Chairman Upton, Chairman Pitts, Ranking Member Waxman, Congresswoman Eshoo, and Congressman Markey, and their staff in strengthening the legislation as it moved through the committee process and in discussions with the Senate. They have all worked in a bipartisan fashion over the past 1\1/2\ years to accomplish the goals of our Members and should be commended for their work.

I also urge Members to join me in supporting passage of H.R. 6672. I'm hopeful that our Senate colleagues will similarly support this bill's passage so we can get the bill to the President's desk.

Madam Speaker, I reserve the balance of my time.

Madam Speaker, I'd like to submit letters of support from the following organizations into the Record: the Alliance for Biosecurity, the American Academy of Pediatrics, the Biotechnology Industry Organization, or BIO, the Roundtable on Critical Care Policy, and a joint letter from four public health organizations. Those are the American Public Health Association, the Association of State and Territorial Health Officials, the National Association of County and City Health Officials, and the Trust for America's Health.

I yield back the balance of my time.

Alliance for Biosecurity, Office of the Secretary and

Legal Counsel,

Washington, DC, December 17, 2012.

Hon. Mike Rogers,

Rayburn House Office Building,

Washington, DC.

Dear Representative Rogers: On behalf of the Alliance for

Biosecurity, I write in strong support of the Pandemic All-

Hazards Preparedness Reauthorization Act of 2012 (H.R. 6672).

The Alliance for Biosecurity is a collaboration of

pharmaceutical and biotechnology companies working to develop

medical countermeasures (MCMs) to prevent and treat diseases

associated with bioterrorism and emerging infectious

diseases. It is essential to our nation's safety that this

bill is passed by the House and Senate before the end of the

112th Congress.

As you know, the chemical, biological, radiological, and

nuclear (CBRN) threat is real and growing. It is critical

that the country continue ongoing efforts to develop,

procure, and stockpile MCMs to both deter an attack and

protect our citizens should a bioterrorism event occur. The

Congressionally-established Commission on the Prevention of

Weapons of Mass Destruction Proliferation and Terrorism 2008

report predicted that ``it is more likely than not that a

weapon of mass destruction will be used in a terrorist attack

somewhere in the world by the end of 2013.'' There is a

limited commercial market for MCMs; consequently, without

adequate advanced development and stockpiling funding,

companies have neither the incentive nor the ability to

invest in these life-saving therapies.

Reauthorization of PAHPA and Project BioShield is critical

to ensuring the sustainability of the MCM enterprise. We

applaud the tireless work of you and your colleagues on this

important issue and urge that this measure is brought up for

consideration in the House and Senate without delay to ensure

that our nation remains prepared to face such threats.

Respectfully submitted on behalf of the Alliance for

Biosecurity.

Maureen Donahue Hardwick,

Secretariat and Legal Counsel.

Madam Speaker, I move to suspend the rules and pass the bill (H.R. 6672) to reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, and for other purposes.

Madam Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and insert extraneous materials in the Record on H.R. 6672.

Madam Speaker, I yield myself such time as I may consume.

Although it has been more than 10 years since September 11 and the anthrax attacks that followed, the threat of bioterrorism remains a very real danger to the American people. Fortunately, we have spent the last decade preparing for chemical, biological, radiological, and nuclear threats by developing and stockpiling numerous medical countermeasures to protect Americans in the event of such an attack. As a result of these efforts, we now have numerous vaccines and treatments in the Strategic National Stockpile that will save thousands of lives if we are attacked. However, the work to protect Americans against bioterrorism is not finished; and we must pass this bill, or the future of America's public health preparedness infrastructure will be in jeopardy.

The Pandemic and All-Hazards Preparedness Authorization Act, known as PAHPRA, is a fiscally responsible bill that represents common ground between the bipartisan House and Senate-passed preparedness bills. I would like to take the opportunity to thank the bipartisan cosponsors, including Chairman Upton and Ranking Member Waxman, as well as our great bipartisan partners in the Senate for their support in what has been a very productive process to ensure the health, preparedness of our States and hospitals for the next flu outbreak or pandemic.

The bill will reauthorize critically important biodefense programs designed to promote the continued development of medical countermeasures against threats and would strengthen the Nation's public health preparedness infrastructure. Reauthorizing these programs is essential to how the Nation would respond to a chemical, biological, radiological, or nuclear attack. PAHPRA will reauthorize critically important programs for 5 years at the fiscal year 2012 appropriated level. The bill would not create a new program nor increase the authorization for appropriations for the existing program.

H.R. 6672 would reauthorize and improve certain provisions of Project Bioshield and PAHPRA. Its passage, I think, is important for the future of our national security here at home.

Madam Speaker, I reserve the balance of my time.

I yield 2 minutes to the distinguished chairman and a great leader of this Congress, the chairman of the Energy and Commerce Committee, the gentleman from Michigan (Mr. Upton).

Madam Speaker, I just want to say thank you and congratulate my friend, Anna Eshoo, for the work that she's done on this bill in such a bipartisan way. I think we would not have advanced to this degree without her great help and assistance.

With that, I would yield 3 minutes to the gentleman from Texas (Mr. Burgess).

Madam Speaker, at this time we have no further speakers, and I would continue to reserve the balance of my time.

Madam Speaker, there are many things that keep me awake at night as the chairman of the House Permanent Select Committee on Intelligence. The growing threat from chemical, biological, radiological, and nuclear attacks not only abroad but here is of growing concern. Instability in governments that possess these materials, an increasing interest from those who would choose to do harm to the United States, desire to get their hands on these materials means that we must prepare ourselves here at home for the unfortunate, I think unlikely certainly in the short term, but possible position of being attacked with these disturbing weapons systems. This is that important step to protect Americans by increasing our stockpiles, and I would urge its passage.

With that, Madam Speaker, I yield back the balance of my time.

Madam Speaker, on that I demand the yeas and nays.

Madam Speaker, I rise in support of H.R. 6672, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2012, and urge my colleagues to support this bill as well.

Madam Speaker, this legislation has been a long time coming. The House version of the

bill passed this body over one year ago; the Senate version was adopted in March of this year. Since that time we have been engaged in a lengthy, but extremely productive process with our Senate colleagues and their staff to come together to bridge the differences between the two bills. H.R. 6672 is the product of that effort. It is our hope that the Senate will pass the bill as soon as possible after the House acts on the legislation today, allowing the critical work authorized under the legislation to continue.

Toward that end, H.R. 6672 reauthorizes and makes minor--but important--improvements to various programs and activities first established in the 2004 Project Bioshield Act and the 2006 Pandemic and All-Hazards Preparedness Act, or as it is commonly referred to, ``PAHPA.'' These programs and activities are key in helping to ensure that our Nation is well prepared to successfully manage the effects of natural disasters, infectious disease outbreaks, and acts of bioterrorism.

H.R. 6672 includes dozens of changes to these underlying authorities. Let me highlight just three provisions that deserve special attention:

The bill targets the Food and Drug Administration, FDA, to ensure that it focuses on medical countermeasures--that is, products designed to combat chemical, biological, radioactive, and nuclear agents--of the highest importance. It requires FDA to work with industry on industry- submitted regulatory management plans for prioritized countermeasures to facilitate scientific exchanges between the FDA and countermeasure product sponsors to streamline our ability to make these products available. Just last Friday, FDA approved the first drug developed and procured under Project BioShield. Raxibacumab is approved for use together with antibiotics to treat anthrax in children and adults. The FDA provisions in H.R. 6672--together with the renewed emphasis in our countermeasure enterprise through other provisions in this legislation--will make it possible for even more drugs and devices to move from early development to procurement.

The legislation also makes improvements to the Nation's blueprint for public health preparedness and response activities that will enhance the ability of our diverse health care system to respond to mass casualty emergencies. Among such improvements are clarifying the role of the Assistant Secretary of Preparedness and Response as the lead office within the Department of Health and Human Services, HHS, for emergency preparedness and response. H.R. 6672 also establishes a new authority to permit the HHS Secretary to approve a request of a state, territory, or an Indian tribe to redeploy certain federally-supported employees during the time of a national emergency to geographic areas where such employees are needed most.

In addition, H.R. 6672 continues support for investments in State and local public health departments. Such investments are necessary to make certain that we have the requisite public health infrastructure in place to respond immediately and appropriately to any public health threat that may arise.

This legislation reflects the effort of a number of members-- Democrats and Republicans alike. On our side of the aisle Congressman Green, Congresswoman Eshoo, Congressman Markey, and our Health Subcommittee Ranking Member--Congressman Pallone--have been deeply involved. I want to thank them and their staff for all the long and incredibly hard work they have put into this legislation and to the process of getting us here today.

I urge my colleagues to vote in favor of H.R. 6672.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 570) to amend the Public Health Service Act to enhance the roles of dentists and allied dental personnel in the Nation's disaster response framework, and for other purposes.

Mr. Speaker, I ask unanimous consent that all Members have 5 legislative days to revise and extend their remarks and include extraneous material on H.R. 570 currently under consideration.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, currently Federal statute deters through omission the incorporation of dental professionals and schools into emergency response plans. H.R. 570 would remedy this omission by incorporating dentistry by name into the Federal disaster response framework. This legislation is endorsed by the American Dental Association and the Academy of General Dentistry, and it passed the House last year on a voice vote.

It recently passed the Committee on Energy and Commerce, the Health Subcommittee, and the full committee, on a voice vote, and 19 members of the Energy and Commerce Committee are currently cosponsors.

In the aftermath of a natural disaster, terrorist attack, or public health emergency, traditional medical delivery systems can become overwhelmed. In these situations it is vital that States work with all qualified and licensed providers to ensure a volunteer workforce to assist in the mitigation of that tragedy. Dentists receive sound general medical background during their professional education and are equipped to take patient medical histories, administer injections, and triage patients. This legislation calls for no new Federal money and poses no new restrictions on moneys now being spent. It simply allows States, at their option, to incorporate dentists and dental facilities into their planning.

I believe this bill will allow us to strategically utilize all available resources and have the ability to deploy the maximum amount of aid in times of disaster. I urge support of this bill.

I want to thank the gentleman from New York (Mr. Towns) for introducing the legislation with me.

I reserve the balance of my time.

Mr. Speaker, I want to take just a moment to thank Candice Miller from Michigan, who was involved in this legislation throughout its course last year and has been very instrumental this year.

I reserve the balance of my time.

Again, Mr. Speaker, I also want to thank Chairman Upton and Chairman Pitts and Ranking Members Waxman and Pallone for their work in passing this bill so quickly through the subcommittee and the full committee. I also want to thank Mr. Stupak for his hard work on the legislation in the last Congress.

Again, I want to acknowledge the work of Candice Miller last Congress and this Congress in getting this bill passed.

In an emergency, all hands on deck. Dentists are willing to support the medical and public health response to a disaster, and this legislation allows States the option to incorporate dentists into their disaster response framework. Our Nation's medical surge capacity will never be optimal until we capitalize on the personnel resources of the entire health care workforce.

I urge full support of this important legislation, H.R. 570, to ensure our national disaster responses have the maximum amount of available resources.

I also want to thank two of my staff members, Rebekah West and James Paluskiewicz, for their hard work in getting this bill to the floor in what appears to be record time.

Again, I urge support for the legislation and for the passage of the bill, and I yield back the balance of my time.

Mr. Speaker, on that I demand the yeas and nays.

I particularly want to thank Mr. Rogers, who has helped shepherd this bill through our committee. I appreciate the very hard work of Chairman Pitts, Ranking Members Waxman and Pallone, along with all the members of our committee to get this bill done and to the floor this afternoon.

Madam Speaker, this bill, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2012, would reauthorize programs designed to encourage the development of medical countermeasures and improve the Nation's health infrastructure to help us respond to a terrorist attack. This bill is very similar to H.R. 2405, the Pandemic and All- Hazards Preparedness Act of 2011, which passed the House last year. This bill, H.R. 6672, reflects common ground reached between the House and Senate through months and months of bipartisan negotiations. I'm hopeful that the Congress, House and Senate, will enact the bill this week so that we can ensure that our Nation is prepared for the unthinkable.

This bill reauthorizes the special reserve fund, the Biodefense Advanced Research and Development Authority, and public health preparedness programs, while eliminating duplicative reports. It also clarifies that the Assistant Secretary for Preparedness and Response is the leader of the Federal Government's efforts on preparedness

and response. This clarification will help in removing duplication, improving coordination, and providing accountability.

The bill also takes important steps to foster medical countermeasure development by ensuring that the FDA's regulations of medical countermeasures are predictable, consistent, and, in fact, transparent. Finally, the bill would provide additional flexibility for emergency distribution, stockpiling, and use of medical countermeasures so the Nation is prepared for whatever may happen.

I would urge all of my colleagues to support the bill. Again, I commend Republicans and Democrats for working together on a bill that really does need to get to the President's desk.