Paul Wellstone

Mr. WELLSTONE

Mr. WELLSTONE. I thank the Chair. Before I proceed, could I make sure? I ask the Chair to please notify me if I should go over 10 minutes, because I do not want to take any more time than that.

Mr. WELLSTONE. Mr. President, I have been allotted 10 minutes. So I will be pleased to lock that block of time.

Mr. WELLSTONE. Mr. President, let me be clear that Senator Kennedy will be on the floor with his motion. I am actually not making a motion. But what I thought I would do is take a little bit of time to talk about one provision in the motion. That is something that I have worked on, and I want to speak a little bit about that.

Mr. WELLSTONE

Mr. WELLSTONE. Madam President, let me speak briefly on this amendment. Let me make three central points, not as an expert on all of the technical detail but I think I speak for the State of Minnesota, or a vast majority of people in my State when I say, first of all, this amendment really is an obvious effort to gag nonprofit organizations. I do not think it makes any sense. Day after day, we have been hearing from a majority in the House and some of my other colleagues about the importance of voluntarism and the value of the private sector in our society. We talk about James Madison, and we talk about Thomas Jefferson, and I can think of the Alex de Tocqueville classic about America, the importance of mediating institutions. That is what these nonprofits are all about. They are the key to an effective civil society. They are ones who get people to participate in a democracy. They are ones who represent the interests of the middle class, of workers and poor people. By the way, all too often they are the only voices for the voiceless. So it does seem to me that this provision--and I have not seen exactly all that is in this modification--would make it very difficult for these groups to fully participate in the democratic purposes of this society. And to the extent that is true, I think it is a loss. Moreover, I think it is a bit deplorable that those who are talking about these kinds of restrictions and are talking about the nonprofit sector, when it comes to others who feed the most from the public trough, the defense contractors and the big businesses, if we want to talk about people who are receiving hundreds of billions of dollars a year, do not gag them at all. I would not be in favor of that anyway, because I think it is a violation of the first amendment to the Constitution, but it does seem to me that there is a sleight of the hand here that we ought to understand. On the one hand, we go after these nonprofits that are all too often, as I said, the only voice for the voiceless, organizations that do wonderful work, that contribute greatly to the civil society, that do a lot of effective social service work and charity work and all of the rest. On the other hand, when it comes to big military contractors, big companies that receive all sorts of benefits, contracts, money from the Federal Government, when it comes to all sorts of large corporations which receive all of these various tax breaks, we do not have any such restrictions on them. It seems to me that this is a double code. It is the same double code--those big contractors, they have the big bucks; they are the heavy hitters; they have the lobbyists. This is not lobbying reform. I have been involved in lobbying reform and the gift ban. This is nothing more than an effort to gag nonprofit organizations. I must say to my colleagues that I find this even more troubling. I was at a press conference today. The Office of Management and Budget released a study--Dr. Rivlin deserves a lot of credit for her intellectual honesty--that what we passed that we called welfare reform will, in fact, on the House side, lead to over 2 million more children being impoverished in America; on the Senate side, a little over 1 million children will be impoverished as a result of legislation that we passed that we called ``welfare reform.'' At the time that we do that we now want to gag these nonprofit organizations which are quite often the only voice for those citizens, including the children. It is a bit outrageous. Finally, Madam President--and I will be relatively brief because I imagine we have a vote coming up soon--I think the definition of political advocacy is such a broad definition, and we are not talking about lobbying, which is restricted. We are not talking about narrow partisan activity. We are saying that if an organization, a nonprofit organization wants to testify before the legislature, somebody wants to write an op-ed piece, somebody wants to do an educational forum, you name it, they may not be able to do that. I think it is transparent what this is all about. I think it has already had a chilling effect in this country. And this is an amendment that ought to be voted down. In any case, even if I was for it--and I am not--it is a gag order. It is an absolutely outrageous double code, with no such effort focused toward military contractors, big corporations. Such an effort should not be focused on them anyway; I would not be in favor of that because of basic first amendment guarantees, but, in addition, it should not be on this continuing resolution. We are talking about whether or not the Government is going to continue to function, for God's sake. We are talking about whether or not we can govern here in Washington. I think people are sick and tired of these games and these amendments that get put on this kind of legislation. Let me conclude by talking about another issue, since I think I have a little bit more time, about which I am deeply troubled. And that has to do with my concern about the low-income energy assistance program which, Madam President, I know is very important to a State like Maine. This program, the low-income energy assistance program--and I was tempted to do an amendment on this continuing resolution; I will not at this time because I think this is very, very serious business--but this is a 6-month heating season program, it is not really a 1-year program. And it is extremely important that the cold weather States get this funding and get this funding out to people. It is true that some LIHEAP funds are used for cooling in places like nursing homes, but in the vast majority of the cases it is cold-weather States. And this money is used to help low-income people pay for furnace repairs and replacements, for fuel and propane tanks being filled, and for emergency assistance to avoid utility shutoff. Madam President, I will tell you what we are doing right now. By not getting the money out to these communities, by having it essentially 30 percent of what it should be, we are basically forcing people to freeze on an installment plan. Madam President, as I said before, this is a stopgap budget bill. If we continue to allocate these dollars, small in amount, for emergency heating assistance for elderly people, people with disabilities, people with children in this fashion, we are going to have some citizens who are going to freeze to death in this country. And then we will be ashamed. Then we will take the action. But, my God, Madam President, I do not want to wait until that point in time. I want to make it clear to my colleagues that we cannot continue to fund programs like the low-income energy assistance program on an ad hoc, partial basis without doing serious harm to millions of families, some of the most vulnerable citizens in this country, who depend upon this program for their very survival during the winter. Madam President, I was considering an amendment to this bill to provide additional LIHEAP funding for the States. But I am not going to do it because we are on the brink of a Government shutdown. I think that would be irresponsible. But I am not going to continue to let this go on month after month, allowing people to freeze on the installment plan. Is that what we want? Do we want to have vulnerable elderly people freeze, some perhaps even freeze to death, before we act to provide adequate low-income energy assistance funding? I do not think so. And I do not think that is what people voted for last year. I do not think we can let this happen. I think we are going to have to do something soon. And if we do not do something soon, that is exactly what is going to happen. It could happen in [[Page S 16874]] North Dakota, it could happen in Alaska, it could happen in Maine, it could happen in Michigan, it could happen in Minnesota, it could happen in any number of the cold weather States in this country. Madam President, this Low-Income Energy Assistance Program has been cut already by 25 percent this past year, and the House of Representatives urged its elimination altogether. The total cost of low-income energy assistance for citizens across this country does not equal one B-2 bomber, and in the House of Representatives they want to eliminate the program. This program right now is down $1.2 billion from 10 years ago, and the need is growing. I have just said to my colleagues that I am extremely worried about what is going to happen. What I am hearing in my State is the funds are going to be depleted in the coming weeks. What is going to happen during the rest of the winter in Maine or in Minnesota or in West Virginia, you name it? What happens in February? What happens in March or later if a cold snap occurs and people are held up without fuel oil or propane or electricity to run their thermostats? What then are we going to do? Madam President, the Low-Income Energy Assistance Program in my State of Minnesota serves about 110,000 households, over 300,000 people. These are poor people. These are elderly people, people with disabilities, families with children. This year we are expecting to provide a supplement of an average of only $200 for the whole winter. The average fuel bill in Minnesota for the vulnerable elderly is between $1,800 and $2,000 a year. So people are carrying most of these costs. The continuing resolution which the House passed last night and upon which we are going to act today provides that only a small percentage of the funds requested by the States in the first quarter, the funds that they need to run the program, are going to be there. Madam President, I just simply have to say one more time that I am concerned. We have this only at about 30 percent of the normal rate. Minnesota is planning cuts of about 50 percent in benefit levels and will be unable to provide assistance to all eligible applicants under the current circumstances. In addition, many programs had to turn away recipients from the crisis program because of this erratic Federal funding. As a result, there are 900,000 households who have empty fuel tanks or who need electric utility connections who have not been served under LIHEAP, and the number is growing. Madam President, one final point. There have been criticisms of this program, many of them coming from warm weather States. But let me just say to my colleagues, this is an effective, highly targeted program that serves 6 million low-income families and helps them pay their energy bills. More than two-thirds of these LIHEAP households have annual incomes of less than $8,000 a year, and one-half of these households have annual incomes below $6,000 a year. I just simply ask my colleagues this question, because I have seen this happen before: Are we going to continue to not provide the funding? Are we going to continue to do this on this ad hoc, sporadic basis? What is going to happen? I already know what is going to happen. Congress diddles, a few sad stories of vulnerable elderly people without heat appear, and then a few more, constituents contact their Members of Congress as the cold worsens, and then a couple of people are found dead in their apartments in the upper Midwest, or in New England, because they were knocked off LIHEAP or were otherwise unable to get their electricity or fuel bills paid and got shut off, or because they were too ashamed, too weak, or unable to bring themselves to ask their families to pay for the bills. And then Congress acts. That is the scenario. That is what is going to happen. We are not providing what is not an income supplement, but a survival supplement. People are not going to be able to afford to pay their heating bills, and people are going to go without. And they are going to be too ashamed to ask or they are going to be too ashamed to turn to their families if their families can provide them with the support, and then they are going to freeze to death. That is not how this process should work. Americans deserve better. That is not what we are about, letting the vulnerable elderly freeze to death on an isolated farmstead or in an urban high rise. We can do much better. And we should start now. We should not continue to provide pitifully inadequate LIHEAP funding to bleed the program for months while Congress struggles to get its work done, to allow people to freeze to death on the installment plan. We can do better. Americans insist on it. I do not think I should do this amendment today, but if this goes on to December--and I know what this is going to mean to people in my State and a whole lot of other States--I am going to bring this amendment to the floor, and I am going to insist that we provide this funding for this program because I will be darned if on my watch as a U.S. Senator from Minnesota, people are going to freeze to death in the United States of America. What are we about? Where is our compassion? Where are our priorities? Where are our values? When are we going to get real again? Madam President, that is where we are heading right now in this Nation, and we have got to do better, and the sooner the better. I yield the floor. Mr. CRAIG addressed the Chair.

Mr. WELLSTONE. I thank the Chair. We are on the Simpson amendment; is that correct?

Mr. WELLSTONE. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. WELLSTONE

Mr. WELLSTONE. Mr. President, I said to my wife, Sheila, this morning that there is nowhere on Earth I would have rather been than in Jerusalem yesterday for this service to honor a very courageous man, Yitzhak Rabin. Mr. President, I will never forget the long lines of the people in Jerusalem in Israel as we drove to the service, as I drove to the service with my colleagues--Democrats and Republicans--to look out of the window and to see the sadness of the people, to see the sadness of the people. Mr. President, I will never forget the words at the service, the words of our President, President Clinton, the words of the Prime Minister's granddaughter. Her words were heard and felt by people all over the world. Nor will I forget the words of King Hussein of Jordan who said, ``I remember my grandfather being assassinated''--the King as a little boy was next to his grandfather--``and now my brother''--my brother; he called Prime Minister Rabin his brother. He said, ``I am not afraid. I am not afraid. If I have to meet that fate,'' the King said, ``so be it, but I am committed to this peace process.'' Mr. President, I just would like to say on the floor of the U.S. Senate that I owe a tremendous debt of gratitude to my State of Minnesota for giving me an opportunity to be a U.S. Senator and giving me an opportunity to be invited to be able to go and to be at that service. I believe that the way that I can honor Prime Minister Rabin--I believe the way that all of us can honor Prime Minister Rabin--whether we are Democrats or Republicans, as leaders in the U.S. Congress, is to dedicate our services to this peace process. [[Page S 16721]] Mr. President, the Prime Minister knew that the status quo was unacceptable. He knew that the status quo extended to the future would only mean that Israeli children and Palestinian children would be killing each other for generations to come. He gave his life for peace. He was a general. He defended his country. He was a military hero. But in the last analysis, at the very end, he gave his life for security for his country and for peace for the peoples of the Middle East. His loss is not only the loss of Israel, his loss is the loss of the peoples of the Middle East, and his loss is the loss to all of us--all of us--who live in this world. So, colleagues, I think that the way that we honor this man, Prime Minister Rabin, is by dedicating ourselves to the peace process. Whenever our country can facilitate negotiations, we should do so. Whenever our country can continue the work of Dennis Roth and others who have been so skillful in helping to mediate and keep these negotiations going, we should do so. When there are terms of the agreement that we are asked to follow through on such as financial aid, economic development, aid to Palestinian people, that the Prime Minister was so much for, we should support that. Mr. President, I hope this does not lead to a period of darkness. Certainly, it feels that way now. This is a nightmare of the world. Let us dedicate ourselves to the peace process. Let us do as public servants what the Prime Minister was able to do. He took the moral position. He did not know how the elections would turn out, but he did what he thought was the right thing. His example of leadership was an example of leadership not just for Israel but for all us that are in public service in all countries throughout the world. As a Senator from Minnesota, as the son of a Jewish immigrant from the Ukraine and Russia, Leon Wellstone, as the son of a daughter of Ukrainian immigrants, Mincha Daneshevsky, as a father, grandfather, a Senator from Minnesota, and an American Jew, I was so proud to be there yesterday. I hope I can live my life, with my family and in my community, and as a Senator, in such a way that I honor this man. I yield the floor.

Mr. WELLSTONE. Thank you, Mr. President. Please excuse me for not wanting to talk about the peace. I want to talk about my grandfather. You always awake from a nightmare, but since yesterday I was continually awakening to a nightmare. It is not possible to get used to the nightmare of life without you. The television never ceases to broadcast pictures of you, and you are so alive that I can almost touch you--but only almost, and I won't be able to anymore. Grandfather, you were the pillar of fire in front of the camp and now we are left in the camp alone, in the dark; and we are so cold and so sad. I am not able to finish this; left with no alternative. I say goodbye to you, hero, and ask you to rest in peace, and think about us, and miss us, as down here we love you so very much. I imagine angels are accompanying you now and I ask them to take care of you, because you deserve their protection. Mr. President, words of Noa Ben-Artzi Philosof, 17, granddaughter of Prime Minister Rabin, at yesterday's service in Israel. I ask unanimous consent that her statement at the service be printed as part of the Record of the U.S. Senate and therefore the record of our country.

Mr. WELLSTONE

Mr. WELLSTONE. I thank the Chair.

Mr. WELLSTONE. Mr. President, I ask unanimous consent that following the Senator from Florida I have 10 minutes and the Senator from North Dakota have 10 minutes in succession.

Mr. WELLSTONE

Mr. WELLSTONE. Of course.

Mr. WELLSTONE

Mr. WELLSTONE. What was the justification? I would like to hear a careful policy justification. But, Mr. President, I will not. Because there is none. I know the pain this inflicts on citizens in my State and I intend to fight this all the way until we change this formula. And above and beyond that, I intend to be a part of an effort in this Senate to make sure that we do deficit reduction but we do it on the basis of a standard of fairness, not on the basis of responding to the people who give the money and who have the clout and have their way and are not asked to tighten their belts. But it is the children, the elderly, people with disabilities, the working families, the people who live in the communities. We are going to change that one way or another. We are going to change that. I yield the floor.

Mr. WELLSTONE. Mr. President, I ask unanimous consent I have 30 more seconds.

Mr. WELLSTONE. Mr. President, first of all, let me just join with the Senator from Massachusetts, and I am sure the Senator from Arkansas. We are ready for the debate. We have some amendments with some instructions to conferees. I do not really understand what the majority party is afraid of. I think we ought to have the debate now. The more I analyze what happened with this reconciliation bill, the more I begin to think about the importance of reform and making this a political process that is responsive to people in the country. I do not mean just the people who are the heavy hitters and the players and the big givers. It is pretty amazing. The pharmaceutical companies come out great, the doctors come out great--though I want to make it clear there are many doctors in my State, I am very proud to say, who do not go along at all with these draconian cuts in health care. They know the pain it is going to inflict across a broad segment of our population in Minnesota. But at the same time as we have some special interests that come out of this just doing great, we have a whole lot of people that get hurt. I just want to focus on one other part of this amendment, the language that will read that provisions providing greater or lesser Medicaid spending in States based upon the votes needed for the passage of legislation rather than the needs of the people of those States, that, in fact, this will be eliminated. I, again, refer to the dark of the night, back-room deal sometime between 6 p.m. and 9 p.m. on Friday evening, where there was wheeling and dealing and Senators in Republican caucus did something like leverage votes for money for States, some kind of process like that. Because all of a sudden we saw a dramatic change in the formula of this amendment. My State of Minnesota wound up with $520 million less between now and 2002 for medical assistance recipients. In my State of Minnesota, and in every State across the land, when we talk about medical assistance we are talking about senior citizens. Two-thirds of the senior citizens in nursing homes in Minnesota rely on medical assistance. And I would far prefer we get serious about real health care reform, and having had a dad with Parkinson's and a mother who struggled with that as well, I am all for home-based care. I want people to be able to live at home in as near normal circumstances as possible, with dignity. But sometimes, for people, it happens. It happened with my parents, and we did everything we could to keep them in their homes, and we did for many [[Page S 16593]] years. The nursing home at the end of their lives became a home away from home. For God's sake, who makes up those cuts? In my State of Minnesota we are talking about 300,000 children; 300,000 children. Medical assistance is an important safety net to make sure that children receive some health care. As a former teacher, I want to make it clear to my colleagues: students--young students, children--do not do well in school when they go to school not having had adequate health care. If a child has an abscessed tooth because that child cannot afford dental care, that child is not likely to do well in his or her elementary school class. For people with disabilities, this is an unbelievably important issue. It is a life or death issue. Because, for families who want to keep their children at home as opposed to institutionalization, the medical assistance payments are critically important. And, for adults who want to get up in the morning and be able to go to work and own their own small business, they need medical assistance for a personal attendant. That is a life with dignity. That is what medical assistance means to those people. So when we are talking about a formula and we are talking about statistics and we are talking about what happened to the State of Minnesota in the dark of night, Friday evening, we are talking about people's lives. What this part of the amendment is going to say, when we give our instructions to conferees, is that we should undo, reverse those provisions which provided medical assistance spending to States based upon the votes needed for the passage of the legislation rather than the needs of the people in those States. I would like to debate that today, I say to my colleague from Arkansas. I am ready for that debate. I am ready for people to tell me who made that decision between 6 p.m. and 9 p.m. What committee met in public? Who voted? Who is held accountable?

Mr. WELLSTONE

Mr. WELLSTONE. I think my colleague should give me a minute to respond.

Mr. WELLSTONE. I say to my colleague from Alaska that I would have been pleased to go on with this debate. I think the national environmental law requires an environmental impact statement. It is not obstructionism to say so. I think for the vast majority of the people in the country, First, they do not believe on environmental grounds, or on energy grounds, that we need to do oil drilling which could threaten the pristine wilderness area, a real treasure for this Nation; and, Second, I think people believe, if you are going to go forward with it, you at least ought to be willing to file an environmental impact statement so we can know what in the world it is going to do. We had the Exxon Valdez oil spill. A lot has happened since 1987. That is not, I say to my colleague, obstructionism for me to come to the floor and to make that clear. I thank the Senator from Utah.

Mr. WELLSTONE. I thank my colleague.

Mr. WELLSTONE. I wonder whether the Senator from Utah would be willing to give me 2 minutes.

Mr. WELLSTONE. Will the Senator yield?

Mr. WELLSTONE. I thank my colleague from Alaska. I wanted to ask the Senator. In the committee I had an amendment which said that if we go forward with oil drilling in the Arctic Refuge there ought to be at least an environmental impact statement that is filed. Can the Senator explain why he disagrees with that? I know in fact we have not had one since 1987. Much has changed since then, and the Secretary stated that an environmental impact statement will be necessary for each new lease sale. This is certainly a new lease sale. Even if you are for drilling in ANWR, I think there is a big argument against it. It is not rhetoric. Why will the Senator at least not be willing to go forward with environmental impact statement?

Mr. WELLSTONE. Mr. President, will the Senator yield?

Mr. WELLSTONE

Mr. WELLSTONE. Mr. President, the legislation I am introducing today would take a significant and responsible step toward improving the effectiveness, timeliness, and predictability of the FDA review process for medical devices. Over the past 9 months, I have met with numerous representatives of Minnesota's medical device industry, patient advocacy groups, clinicians, and officials at the FDA and have concluded that there are indeed steps that Congress should take to make the regulatory process for medical devices more efficient. Minnesotans want the FDA not only to protect public health, but also to promote public health. They want to know not only that new technologies will be safe, but that they will be available to them in a timely manner. Many of Minnesota's medical device manufacturers, researchers, clinicians, and patients in need of new and improved health care technology have become increasingly concerned about the regulatory environment at the FDA. Two weeks ago I visited SpineTech, which is a perfect example of Minnesota's burgeoning, world-famous medical device industry. It was formed in 1991 with 4 people, funded by venture capital, and it now employs more than 40 people. It manufacturers a breakthrough disc replacement technology which has been studied in clinical trials for 3 years. The technology, used for individuals with chronic low-back pain, has been shown to result in shorter hospital stays, less invasive surgery and lower medical costs than the alternative therapy. SpineTech filed its premarket approval application in January of this year. The application has not yet been accepted by the FDA and thus the premarket approval process has not yet even officially begun. The average total elapsed time for FDA review of PMA applications is now about 823 days. The technology has been available in every other advanced industrialized country for the past 2 years. The technologies that the FDA regulates are changing rapidly. We cannot afford a regulatory system ill-equipped to speed these advances. As a result, both Congress and the administration are reexamining the paradigms that have governed the FDA. Our challenge will be to define FDA's mission and scope of responsibility, as well as to give guidance on an appropriate balance between the risk and rewards of streamlining all aspects of how FDA does its job--including the approval process for breakthrough products. The legislation that I will be introducing would begin to address these objectives in three important ways. First, it would enable the FDA to adopt nationally and internationally recognized performance standards to improve the transparency and effectiveness of the device review process and promote global harmonization and interantional trade. Resource constraints and the time-consuming rulemaking process have precluded FDA promulgation of performance standards in the past. This legislation would allow the FDA, when appropriate, to simply adopt consensus standards that are already being used by most of the world and use those standards to assist in determining the safety and effectiveness of class III medical devices. The FDA could require additional data from a manufacturer relevant to an aspect of a device covered by an adopted performance standard if necessary to protect patient safety. Currently, the lack of clear performance standards for class III medical devices is a barrier to the improvement of the quality and timeliness of the premarket approval process. Second, it would improve communication between the industry and the FDA and the predictability of the review process. I believe that these two factors are so important that I have even included what would usually be management decisions in the legislation. This bill includes provisions for periodic meetings betwen the applicant and the FDA to ensure that applicants are promptly informed of any deficiencies in their application, that questions that can be answered easily would be addressed right away, and that applicants would be well-informed about the status of their application. I believe that improving communication between the FDA and industry would result in greater compliance with regulations and that this will ultimately benefit consumers and patients. Third, the legislation would help the FDA focus its resources more appropriately. PMA supplements or 510(k)s that relate only to changes that can be shown to not adversely affect the safety or effectiveness of the device would not require premarket approval or notification. Manufacturers would instead make information and data supporting the change part of the device master record at the FDA. In addition, the FDA would be able to exempt from premarket notification requirements those class II devices for which such requirements are unnecessary to ensure the public health without first having to go through the time consuming and bureaucratic process of reclassifying them to class I. Enabling the FDA to focus its attention where the real risks are will not only streamline the approval process but also benefit consumers and patients. Finally, I want to be clear that this legislation is a work in progress. I look forward to working with Senator Kassebaum, the chairman of the Labor and Human Resources Committee, and my colleagues on the committee on the concepts included in my proposal. I will work vigorously to ensure they are included in any comprehensive FDA legislation considered by the Senate both this year and in the future. I look forward to continuing to work on these issues with Minnesotans and to pressing ahead next year on whatever we cannot accomplish this year. Clearly there are actions Congress can take to improve the FDA without scarificing the assurances of safety that all Americans depend on. Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. WELLSTONE

Mr. WELLSTONE. Mr. President, the legislation I am introducing today would take a significant and responsible step toward improving the effectiveness, timeliness, and predictability of the FDA review process for medical devices. Over the past 9 months, I have met with numerous representatives of Minnesota's medical device industry, patient advocacy groups, clinicians, and officials at the FDA and have concluded that there are indeed steps that Congress should take to make the regulatory process for medical devices more efficient. Minnesotans want the FDA not only to protect public health, but also to promote public health. They want to know not only that new technologies will be safe, but that they will be available to them in a timely manner. Many of Minnesota's medical device manufacturers, researchers, clinicians, and patients in need of new and improved health care technology have become increasingly concerned about the regulatory environment at the FDA. Two weeks ago I visited SpineTech, which is a perfect example of Minnesota's burgeoning, world-famous medical device industry. It was formed in 1991 with 4 people, funded by venture capital, and it now employs more than 40 people. It manufacturers a breakthrough disc replacement technology which has been studied in clinical trials for 3 years. The technology, used for individuals with chronic low-back pain, has been shown to result in shorter hospital stays, less invasive surgery and lower medical costs than the alternative therapy. SpineTech filed its premarket approval application in January of this year. The application has not yet been accepted by the FDA and thus the premarket approval process has not yet even officially begun. The average total elapsed time for FDA review of PMA applications is now about 823 days. The technology has been available in every other advanced industrialized country for the past 2 years. The technologies that the FDA regulates are changing rapidly. We cannot afford a regulatory system ill-equipped to speed these advances. As a result, both Congress and the administration are reexamining the paradigms that have governed the FDA. Our challenge will be to define FDA's mission and scope of responsibility, as well as to give guidance on an appropriate balance between the risk and rewards of streamlining all aspects of how FDA does its job--including the approval process for breakthrough products. The legislation that I will be introducing would begin to address these objectives in three important ways. First, it would enable the FDA to adopt nationally and internationally recognized performance standards to improve the transparency and effectiveness of the device review process and promote global harmonization and interantional trade. Resource constraints and the time-consuming rulemaking process have precluded FDA promulgation of performance standards in the past. This legislation would allow the FDA, when appropriate, to simply adopt consensus standards that are already being used by most of the world and use those standards to assist in determining the safety and effectiveness of class III medical devices. The FDA could require additional data from a manufacturer relevant to an aspect of a device covered by an adopted performance standard if necessary to protect patient safety. Currently, the lack of clear performance standards for class III medical devices is a barrier to the improvement of the quality and timeliness of the premarket approval process. Second, it would improve communication between the industry and the FDA and the predictability of the review process. I believe that these two factors are so important that I have even included what would usually be management decisions in the legislation. This bill includes provisions for periodic meetings betwen the applicant and the FDA to ensure that applicants are promptly informed of any deficiencies in their application, that questions that can be answered easily would be addressed right away, and that applicants would be well-informed about the status of their application. I believe that improving communication between the FDA and industry would result in greater compliance with regulations and that this will ultimately benefit consumers and patients. Third, the legislation would help the FDA focus its resources more appropriately. PMA supplements or 510(k)s that relate only to changes that can be shown to not adversely affect the safety or effectiveness of the device would not require premarket approval or notification. Manufacturers would instead make information and data supporting the change part of the device master record at the FDA. In addition, the FDA would be able to exempt from premarket notification requirements those class II devices for which such requirements are unnecessary to ensure the public health without first having to go through the time consuming and bureaucratic process of reclassifying them to class I. Enabling the FDA to focus its attention where the real risks are will not only streamline the approval process but also benefit consumers and patients. Finally, I want to be clear that this legislation is a work in progress. I look forward to working with Senator Kassebaum, the chairman of the Labor and Human Resources Committee, and my colleagues on the committee on the concepts included in my proposal. I will work vigorously to ensure they are included in any comprehensive FDA legislation considered by the Senate both this year and in the future. I look forward to continuing to work on these issues with Minnesotans and to pressing ahead next year on whatever we cannot accomplish this year. Clearly there are actions Congress can take to improve the FDA without scarificing the assurances of safety that all Americans depend on. Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. WELLSTONE

Mr. WELLSTONE. Yes, it is.

Mr. WELLSTONE. In the conference report language, it is stated that $55.3 million is provided for biofuels energy systems. When $27.65 million is taken out for biochemical and thermochemical conversion, that leaves another $27.65 million. Then $3.94 million goes to the regional biomass program and full funding is provided for biomass power projects in Vermont and Hawaii. There is no instruction for the remainder of the nonbiochemical and nonthermo- chemical biomass funding. Am I correct in stating that that remainder could be applied to the Biomass Power for Rural Development Program?