Barbara Mikulski

Ms. MIKULSKI

Ms. MIKULSKI. Thank you, Mr. President. I rise today to join my very distinguished colleague, the Senator from Missouri, to offer for the Senate's consideration the conference agreement on the VA-HUD bill. This bill contains $99 billion--$99 billion--in outlay spending, of which almost $20 billion is in mandatory spending. This isn't just about numbers though. And it will not be about statistics; this is about people. The VA-HUD bill is probably one of the most complex that comes before the Senate. In terms of dollar amounts, it ranks up there with defense, and it ranks up there with the Labor, Health and Human Services budget. What it does in terms of dollar amounts, though, is it really is focused on two policy objectives. No. 1, how do we respond to the day- to-day needs of our constituents, those veterans who need health care or access to a mortgage, or constituents who need housing, whether it is housing for the elderly, or housing for neighborhoods trying to rebuild themselves, or in response to the need for emergency assistance? At the same time, this subcommittee gets America ready for its future. It is significant in public investments in science and technology. That is where we have tried to make wise and prudent choices, on how we respond to the day-to-day needs of the American people and at the same time help our country get ready for the future. I believe that, working on a bipartisan basis, we have been able to do this. I thank my colleague, Senator Bond, for the collegial manner in which he and his staff have worked with my staff and myself to craft a bipartisan bill that represents the best interests of the American people. I am very pleased to say that when it has come to meeting the health needs of our veterans, whether it has been making sure that the housing needs are met, and at the same time whether it is our space program or our investments in information technology, we have not played politics. Isn't this what the American people want us to do? For the people who risked their lives at Iwo Jima, Pork Chop Hill, Desert Storm, the Mekong delta, they want us to get out there and get up every day and see how we can be responsible in meeting their needs and not play politics with their needs. Well, we looked at people who need public housing or subsidized housing, how we can ensure that housing is not a way of life but a way to a better life. Isn't that what the American people want us to do? When they look to not only the Stars and Stripes, but they look out there to the stars of the universe, they want the United States of America to lead the way. They do not want us to play politics with our space program. And we have not done that. At the same time, they know a new century is coming, a new economy is on its way. We need groups like the National Science Foundation, in its investments in information technology and other basic scientific research, to do that basic research which the Federal laboratories and our universities are best at, so that we can then turn to the private sector to value add where public investments in publicly funded research will lead to the private-sector jobs. And they do not want us to play politics with that. And guess what? We did not. So, Mr. President, as we come before you with this VA-HUD bill, I think that is what we have done. We have moved this legislation forward. I think the numbers speak for themselves. We have provided $300 million more for VA medical care than the budget agreement because we said, ``Promises made should be promises kept to our veterans.'' We wanted to be sure that the VA medical research could continue to be funded in a way that meets the important practical clinical research that is important. I am so pleased that we are going to be doing research on gulf war syndrome. I am particularly pleased that we have the set-aside for both Parkinson's disease and prostate cancer. With quality VA medical care and research, we are providing real help for real people. When we look at our housing and urban development, we once again make sure that we adequately fund the very successful program that funds housing for the elderly in our local communities. This committee was concerned, though, about two things. First, we were concerned that the way section 8 was being funded could inadvertently result in yet one more unfunded liability to taxpayers and a hollow opportunity for the poor. The Senator from Missouri, Senator Bond, has been an architect of reform in this area. I have noted with great pleasure the way he worked with the administration in terms of fashioning a compromise where we meet our fiscal and social responsibility simultaneously. We also fund something called HOPE VI which says that public housing should not be a way of life but a way to a better life. We have come up with not only a new physical infrastructure, but a new social infrastructure that says, if you get a subsidy, you have to get yourself, your family, and your community ready for the future because it mandates that you must be in job training and it mandates also that you must be engaged in community service in your own area. This way we build the capacity of the individual, we build the community in which that individual lives, and we get value not only for the taxpayer, but the lives of residents will be transformed forever. Again, this committee provided real help for real people. This year, when we looked at the environment, the President's request had many items we worked on, from Superfund to Brownfields, clean air to clean water. What we have been able to do is not only work on these issues, but also lay the groundwork for the research that needs to be done to be sure that we have sufficient science for a regulatory framework. I am very grateful for the response of the Senator from Missouri when I came to him when Maryland was hit by a terrible tragedy in which we had a fish kill over on our Eastern Shore. We had thousands of fish die. Our great medical community was concerned that it was having a dire effect on the physical and public health of our community. Before we responded inappropriately, we felt that we needed to have our Federal laboratories engaged so that they could support not only Maryland, but other affected States like Virginia and North Carolina, so we could come up with wise solutions to protect public health and also maintain the community. I want to thank Senator Bond for responding to my request for $3 million that will fund EPA to find a solution to a problem called the pfiesteria, an ``X Files''-like organism that goes from a vegetable to an animal and then attacks fish in a vicious way. What we are able to do now is to provide the best science to come up with the best solutions to be able to protect lives, protect the Chesapeake Bay, and protect our economy. I want to thank the Senator for responding to that because it was a last-minute, but certainly a much needed request. In NASA, we also talked about how we maintain our core programs-- safety for the shuttle, we will fly high in the space station, and we will once again have adequate funding for Mission to Planet Earth. While we study the great universe, we also need to look back on the one planet where we do believe there is intelligent life, and that is our own dear planet Earth. Thanks to this we will be able to study our planet as if it were a distant planet and come up with new ways of doing business, where we can predict earthquakes, where we can predict floods, where we can predict famine, and using the tools of science, we can help countries all over this planet be able to protect themselves from either the dire effects of nature or the dire effects that we bring upon ourselves. I am also particularly pleased that, once again, the chairman responded to a request from both the administration and from this side of the aisle to maintain the National Service Program. This is a program where we ask young people to volunteer in their communities, and while they are doing that, receive a voucher to reduce their student debts, and at the same time give back to their community. There are many aspects of this bill which we could elaborate on, but the one that we probably have to respond to most immediately is the Federal Emergency Management Agency. FEMA is the 9-1-1 agency for the American people. Unfortunately, just about every Senator's State had a call on FEMA. We were able to respond to that, and once again, we worked on a bipartisan basis. What we are also going to do now is to practice the three R's of emergency management: readiness and preparedness, response when a disaster hits, and restoration. Only this time when we restore, we are not going to only restore, we will take steps to help communities reduce the impact from future natural disasters like hurricanes and floods. Mr. President, we could talk about the legislation, but what I am here to say today is that what we have done in this subcommittee is that we have responded to the needs of the American people, we have gotten ourselves ready for the future, we have been fiscally responsible, and we have done it on a bipartisan basis. At the end of the day, I don't think we can do better than that. I will be able to go back to my constituents in Maryland and say, ``We think we have done a good job for you. We think we have done a good job for America.'' I thank Senator Bond and his staff for the way they worked with us, particularly John Kamarck, Carrie Apostolou, and a wonderful detailee, Sarah Horrigan. I also want to thank my staff, Andy Givens, David Bowers, and also another detailee, a science whiz kid like Sarah, Stacy Closson, who came to us to learn about how the Senate works, while we have a better insight into how science works. Mr. President, I think that concludes my remarks. I yield the floor and I will look forward to the passage of the bill.

Ms. MIKULSKI

Ms. MIKULSKI. Mr. Chairman, I agree completely with what you just stated. The provisions that have been negotiated between FDA and industry and set forth in the sideletter from the Secretary are a key part of PDUFA. These provisions cover electronic submissions, meeting management goals, clinical holds, major dispute resolution, special protocol question assessment and agreement, and additional procedures, such as action letters. Not only should these performance goals be considered fully binding on the agency, they should be considered as minimum, not maximum commitments. If the agency can do better, it should. I know that FDA will do its best to exceed the performance goals and other matters spelled out in the letter, just as it has exceeded its commitments in the 1992 PDUFA letter. Effective and aggressive oversight of the fda

Ms. MIKULSKI. I thank the Senators from Massachusetts and Vermont for their very kind comments. I also thank you for the cooperation of your staff, and wish to acknowledge the role of Lynne Lawrence and Roberta Haeberle. But let's get FDA the right staff that they need.

Ms. MIKULSKI. Madam President, I would like to have the chairman's understanding of the letter to be submitted by the Secretary of Health and Human Services concerning the performance goals of the FDA in connection with the reauthorization of the Prescription Drug User Fee Act of 1997, PDUFA.

Ms. MIKULSKI. Mr. President, thank you. Mr. President, in a few hours we will be voting on the final passage of the FDA Modernization and Accountability Act. I am so pleased that this day has finally arrived. I thank the chairman of the Labor Committee, Mr. Jeffords, for all of his incredible patience, persistence, dedication, and attention to really lead the mission to move FDA into the 21st century. I thank him for his heartfelt devotion to accomplishing this mission and for never giving up. I also want to thank his staff for their hard work and for the bipartisan, nonpartisan way in which they worked. Let me also acknowledge the tremendous contribution of the ranking member, Senator Kennedy. There is no doubt that this is a better bill and FDA will be in better shape because of his efforts. Mr. President, I have worked on FDA reform for a number of years. When I was a Member of the House of Representatives, we embarked, on a bipartisan basis, to ensure consumer protection, to prevent dumping of drugs that did not meet our standards into Third World countries. Then coming to the Senate, I joined with my colleague from Massachusetts, Senator Kennedy, and with the Senator from Utah, Mr. Hatch, in fashioning something called the Prescription Drug User Fee Act, otherwise nicknamed PDUFA. What PDUFA did is provide, through a user fee mechanism, the ability to hire 600 more people at FDA to analyze the safety and efficacy of pharmaceuticals to move them to the marketplace. Because of PDUFA and the great legislative idea of Kennedy-Hatch, FDA was able to hire more people to examine products that were being presented for evaluation and get them to clinical practice more quickly. The leadership of Kennedy-Hatch on PDUFA has not only stood the test of time, but it has shown that we can expedite the drug approval process while maintaining safety and efficacy. But while PDUFA made a huge difference, it became clear that PDUFA was not enough. More staff operating in an outdated regulatory framework without a clear legislative framework was deficient. That is when we began to consult with experts in the field of public health, particularly those involved in drugs and biologics on where we needed to go. While we were considering this, the world of science was changing. We were experiencing a tremendous revolution in biology. We went from basic discoveries in science, particularly in the field of chemistry and physics, to a whole new explosion in biology and genetics and biologic materials. We also went from a smokestack economy to a cyberspace economy in which the very tools of information technology could enable us to improve our productivity. It became clear that we needed an FDA with a new legislative framework and a new culture and a continued commitment to the traditional values of safety and efficacy. This is when we began to put together what we called the sensible center on FDA reform. One often hears about partisan bickering. One often hears about prickly relationships between the two parties. But I tell you, thanks to the leadership of Senator Kassebaum, who initially chaired this initiative, we, Republicans and Democrats, worked together because we never wanted to play politics with the lives of the American people. What we wanted to do is to make sure the American medical community and the world medical community had the best clinical tools at their disposal to help save lives. We saw the reform of FDA accomplishing two important policy goals-- saving lives and at the same time generating jobs in our own American economy in the fields of pharmaceuticals, biologics, and medical devices. Senator Kassebaum took important steps forward. Senator Jeffords assumed that mantle and brought us to this point today. What will this bill do? Why is it so important? It gives, first of all, a clear statement on what is the mission and purpose of FDA--to save lives with pharmaceutical and biologic products and to maintain the safety of our food supply. This bill does not deal with the food safety issue, but it sure does focus on those things that normally would take place in clinical practice. Why is it so important? It streamlines the regulatory process, it reauthorizes that very highly successful PDUFA, to make sure we have adequate staff, and it creates an FDA that rewards significant science while protecting public health. It means that new lifesaving drugs and devices will get into clinical practice more quickly. It will enable us to produce products that we can sell around the world saving lives and generating jobs. What is so great about pharmaceuticals, biologics, and medical devices is that they are translingual, they are transcultural. When you need a new drug and it is approved by FDA, whether you live in Baltimore or whether you live in London or whether you live in Bangladesh, you need it. If you then use a medical device, you know if it is safe in Maryland, it will be safe in Moscow or Malaysia. This is why this will offer us a whole new opportunity in exports. I am really proud of FDA. I am proud of all the people who work at FDA, and under very Spartan resources. Why? Because it is known as the gold standard around the world for product approval. We want to maintain that high standard, and at the same time we want to make sure that the FDA is ready to enter the 21st century. This legislation will be the bridge to the future, maintaining the evaluation of safety and efficacy with the new tools to be able to participate in a 21st century science environment and a 21st century economy. This bill sets up a new legislative and regulatory framework which reflects the latest scientific advancements. That framework continues the FDA's strong mission to public health and safety, but it sets a new goal for FDA--enhancing public health by not impeding innovation or product liability through unnecessary red tape that only delays approval. There is an urgency about reauthorizing PDUFA. Its authority expires at the end of this month. PDUFA has enabled FDA to hire 600 new reviewers, and to cut review times from 29 to 17 months over the last 5 years. If we fail to act now, it means the people who have been working on behalf of the American people and the world will get RIF notices. We cannot let them down, because we do not want them to let the American people or the world down. We risk losing talented employees and slowing down the approval process. Delay will hurt dedicated employees, but more importantly it will hurt patients. Patients benefit the most from this legislation. Safe and effective new medical tools will be helping patients live longer lives or get better quicker. We are not just extending PDUFA. We are improving it. Currently, PDUFA only addresses something called the review phase of the approval process. Our bill extends PDUFA to streamline the early drug development phase as well. What does this mean? New innovations. We are going to be able to allow for electronic submissions. We want to improve productivity. Instead of carloads of paper, stacks and stacks of material not being able to be utilized in an efficient way being deposited at FDA, companies will be able to make those electronic submissions. This reduces not only paperwork but actually provides a more agile way for scientific reviewers to get through the data in a way that improves efficiency while they are analyzing efficacy. Updating the approval process for biotechnology is another critical component of this bill. Biotechnology is one of the fastest growing industries in our country. In my own State of Maryland, there are 143 of these companies. They are working on everything from AIDS to Alzheimer's to Parkinson's disease, to breast and ovarian cancer, as well as new immunizations for children. These are absolutely vital areas of endeavor. We want to be able to help them develop these new areas, go through a submission at FDA to make sure they are safe, and get new products out there doing their job of improving people's health. The job of FDA is to make sure that safe and effective products get to our patients. Our job, as Members of Congress, is to fund scientific research through NIH and other Federal laboratories and extramural research at great institutions like the University of Maryland and Johns Hopkins and at the same time to provide FDA the regulatory and legislative framework to evaluate new products to make them available to doctors and to patients. That is why I am fighting for this. There have been many issues raised in this debate. Some have been very robust. Some have even been prickly. But I tell you, I want to absolutely say that I am on the side of FDA. I am absolutely on the side of safety. I am absolutely on the side of efficacy. I believe this is what this bill does. This legislation should not be a battle of wills, it should not be a battle over this line item or that line item. It should be really a battle over what is the best way to make sure the American people have from their physicians and other clinical practitioners the best devices and products to be able to save their lives. Mr. President, my dear father died of Alzheimer's. He was in the final stages when I became a U.S. Senator. He was so ill that he could not come to that marvelous night in my life when I won the general election and knew I would be the first Democratic woman ever elected in her own right. I spoke to my father that election night, via TV because he could not be there, to thank him for what he did for me and my sisters. With Alzheimer's, I watched my father die one brain cell at a time. It did not matter that I was a U.S. Senator, it did not matter that I was helping fund research at NIH, my father was dying. My father was a modest man. He didn't want a fancy tombstone or a lot of other things, but I vowed, I promised, in my heart of hearts I would do all I could to find a cure for Alzheimer's. I would do all I could for those people who have Alzheimer's or other forms of dementia or other mind diseases. While I did that, I promised also that I would do all I could to make sure those tools moved to the clinical practice as fast as they could. Every one of us has faced some type of tragedy in our lives where we look to the American medical, pharmaceutical, biological, and device communities to help us. I have done that so many times. I am grateful to the medical communities in the United States of America. When my own mother had one of her last horrible heart attacks that was rapidly leading to a stroke there was a new drug that was so sophisticated that if it was administered quickly could help her avoid having a stroke. It required informed consent, because even though it was approved it was so dramatic in the way it thins the blood, almost to a hemophilia level, that you needed consent on the scene. I heard all of the medical pros and cons of that. I was advised by a great clinician at Mercy Hospital and I gave that approval because my mother was not conscious and not able to do that. And guess what? That new drug approved by FDA, developed in San Francisco, got my mother through her critical medical crisis with the hands-on care of the Sisters of Mercy at Mercy Hospital. My mother did not have a stroke because we avoided the clotting with the help of this new dramatic drug. I give praise and thanksgiving to God for that and the ingenuity of the American medical community that enabled my mother to stay with us 100 more days so she could be back at home, have conversations with us, her grandchildren, and so she could, even in her final days, continue a telephone ministry that she had. She was a member of a parish group called the Cheer Up Club where other shut-ins called each other. Let me tell you, the best ``Cheer Up Club'' I can belong to is right here in the U.S. Senate when we pass FDA reform to make sure that when a physician works with a patient or a family they are cheered because they have these new tools. Mr. President, I thank you for the time given to me to speak today. If I seem a little emotional, you bet. I love my family, as so many of us do, and this is why I so rely upon the American medical community and FDA to make sure that the best pharmaceutical, biological, and medical devices are available to the American people and also to the people of the world. I look forward to voting for final passage and having a conference report to bring back.

Ms. MIKULSKI

Ms. MIKULSKI. Mr. President, I rise to cosponsor Senator Harkin's amendment to establish the Center of Alternative Medicine. I helped him establish the Office of Alternative Medicine in 1993 at NIH. Why did I do that? One, because I want everyone who is sick in the United States of America to have access to all possible means of treatment that are safe and have efficacy. At the same time, I wanted to prevent quackery. I also was aware of the Harvard study by a Dr. Eisenberg that said one out of three Americans was using alternative or complementary medicine, but we were not aware of scientific investigation to establish its efficacy or its safety. Yet, many of us have enjoyed those practices. Some years ago, I had some very severe illnesses. Western medicine was of limited utility for me and I turned to acupuncture. Acupuncture helped me get well and has helped me stay well. I am pleased about that. But there are many other modalities out there being utilized by the American consumer. I want to make sure they are safe. I want to make sure they have efficacy. I want NIH to investigate it, and then I want them to validate it. I believe there is merit in this. I am puzzled why NIH wants to continually try to submerge this Office of Alternative or Complementary Medicine. The hallmark of NIH is to have an open mind and to pursue scientific investigation. I believe Senator Harkin is on the right track. Though this amendment might not be germane, it is certainly relevant to the American people. If we don't find a way to move it on this bill, let's explore other ways. I yield back such time as I might have.

Ms. MIKULSKI

Ms. MIKULSKI. Mr. President, I rise today in opposition to the Ashcroft amendment. This amendment would eliminate the National Endowment for the Arts [NEA], an organization which has come under unfair attack in the past few years. Funding for the NEA has consistently dropped. Funding last year was $99.5 million, a 39-percent decrease in 2 years. Now, many of my colleagues want to abolish the endowment completely. I disagree with this approach. For every Federal dollar invested in the arts, our citizens receive an enormous return. My state of Maryland received $1.4 million in arts funding last year. This means that the Baltimore Childrens Theater Association is able to thrive. It means that the Baltimore Museum of Art can bring world renown exhibits to the citizens of my State. And it means that local communities throughout Maryland have access to community festivals, arts centers, and galleries. There is a myth that the arts are for the elite. However, I believe the arts are about three things: Jobs, economic development, and families. The arts attract jobs. The arts help create economic development in communities. The arts are family first. The cost of Federal funding for the arts is 35 cents for every citizen. The arts are a sound investment. The rewards are great. Federal funding for the NEA has led to the flourishing of arts organizations in small cities and rural areas across the country. In my State of Maryland, local arts agencies are able to leverage Federal dollars for their fundraising efforts. Without Federal support, Marylanders wouldn't have the Puppet Co. in Glen Echo, the Bluebird Blues Festival at Prince George's Community College, the Writers Center in Bethesda, or the University of Maryland music programs. I am committed to protecting the Federal role in the arts. We should not become the only civilized country in the world that does not support the arts. I urge my colleagues to join me in opposing the Ashcroft amendment.

Ms. MIKULSKI

Ms. MIKULSKI. Mr. President, in a week already saddened by the loss of Diana, Princess of Wales, we were further grieved to learn Friday of the death of Mother Teresa. Her presence, that of a living saint, will be sorely missed. Mother Teresa has played the role of world conscience. Throughout her life, she has lived in the most pure and basic manner. While caring for the destitute and sick, she insisted on living in poverty herself. Mother Teresa believed that ``the more we empty ourselves, the more room we give God to fill us.'' She practiced what she preached. Mother Teresa's remarkable and selfless works have been recognized around the world. In 1979, she was awarded the Nobel Peace Prize. In 1980, she was bestowed India's highest honor, the Jewel of India award. Last year, President Clinton conferred honorary American citizenship on Mother Teresa. Most recently, she was awarded a congressional Medal of Honor. Mother Teresa knew that these were merely earthly rewards. While she was an international figure, she remained focused and committed to her mission. She rejected the media attention these awards drew, saying that she must get back to her work. Any money that came with these awards was immediately given to the poor. Mother Teresa will be sadly missed but her work will continue. I pray that Sister Nirmala will be given the same strength and world support to continue the mission Mother Teresa founded in 1948, the Order of the Missionaries of Charity. I also pay tribute to Mother Teresa's life by recommiting myself to work for the poorest members of society. Mr. President, I yield the floor.

Ms. MIKULSKI

Ms. MIKULSKI. Thank you very much. I wish to say to my colleagues, we have worked very long and hard to move FDA reform ahead, to make sure that products, whether they be pharmaceuticals, biologics, or cosmetics, are available in a safe way to the American people. There are policy differences, but they should be decided on the basis of debates and votes. We should not hold up reform on the basis of process. Let us vote for cloture. Let us move the bill forward. Let us resolve our differences in the usual and customary way. I ask my colleagues to join with me to vote for cloture, and then move forward in an adequate, robust and well-amplified debate on the issues. I thank the Senator from Indiana.

Ms. MIKULSKI. I announce that the Senator from Kentucky [Mr. Ford] and the Senator from Ohio [Mr. Glenn] are necessarily absent.

Ms. MIKULSKI

Ms. MIKULSKI. Mr. President, I thank the chairman for his leadership in bringing about not only a reform structure for FDA that preserves both the safety and efficacy of pharmaceuticals, biologics and other products that the American people utilize, but also for the fact that he has been able to move this legislation to the floor. I also extend my compliments to Senator Kennedy for his longstanding commitment to public health, to public safety, and at the same time being able to maintain the whole idea of developing jobs in our own country. Mr. President, I have been working on FDA reform for a number of years. I worked on FDA reform when I was a Member of the House of Representatives on the Energy and Commerce Committee, serving under then Congressman Dingell, where we embarked, on a bipartisan basis, to ensure consumer protection and that we did not dump our drugs that did not meet our standards on third world countries. Coming to the Senate, I joined with my colleague from Massachusetts and the Senator from Utah, [Mr. Hatch], in fashioning legislation called PDUFA, the Prescription Drug User Fee Act, which enabled a very important tool to go into place in which we could hire more people to come to FDA to examine the products that were being presented for evaluation, to be able to move them to clinical practice in an expeditious way. The leadership of Kennedy-Hatch on PDUFA has not only stood the test of time, but has really been shown as a test for being able to expedite approval processes and maintaining safety and efficacy. But it was clear that PDUFA was not enough, that more staff operating in an outdated regulatory framework, without a clear legislative framework, was deficient. That is when we began to consult with experts in public health, those involved in public policy related to food, particularly with drugs and biologics. And in the meantime, while we were considering all this, something came into the world which was the revolution in biology. We had gone from a smokestack economy to a cyberspace economy. We had gone through basic discoveries in science from the field of chemistry and physics to a whole new explosion in biology, which is truly revolutionizing the world, whether it is in genetics or other biologic materials. These offer new challenges to ensure their safety and efficacy, new staff and a new legislative framework. What we then said is that we needed an FDA with a new legislative framework and a new culture. This is then when we tried to put together what we called the sensible center, working with Republicans and Democrats alike, because we certainly never want to play politics with the lives of the American people to come up with it. Senator Kassebaum chaired the committee during this initiative. We took important steps forward. I say to Senator Jeffords, you have assumed that mantle, and I think you have improved on the original legislation that Senator Kassebaum had written. I was proud to participate for several reasons. One, I have the pleasure and the honor of having FDA located in Maryland. I cannot tell you the enthusiasm to be able to have the National Institutes of Health in Bethesda and FDA in Rockville, really looking at the life science endeavors, the ingenuity, creativity and scientific know-how, to come up with basic knowledge, to work extramurally in these wonderful institutions in Maryland, in Massachusetts, and Vermont, academic centers of excellence, to come up with fantastic new ways of saving lives and at the same time generating jobs. Through the work, then, of Secretary Shalala and the Vice President, we did make some improvements. But we must codify those improvements. So this is where we come to today. What I like about the legislation here is that it streamlines and updates the regulatory process for new products, it reauthorized that highly successful Prescription Drug User Fee Act, and it creates an FDA that rewards significant science and evaluation while protecting public health. Now, what is the end result of the legislation that we will pass? It will mean that new life-saving drugs and devices will get into clinical practice more quickly, and it will enable us to add products that we can sell around the world and, through this, save lives and generate jobs. FDA is known the world over as kind of the ``gold standard'' of the approval of products. We want to maintain that high standard. We want to maintain its global position. At the same time, we want to make sure that FDA can enter the 21st century. This bill gets us there. It sets up a new legislative and regulatory framework that reflects the latest scientific advancements. The framework continues FDA's strong mission to protect public health and safety and at the same time sets a new goal for FDA, enhancing public health by not impeding innovation or product availability through unnecessary processes that only delay the approval. We are considering a very important issue today. I would just like to reiterate the importance that no matter what the outcome of this bill, we must pass the reauthorization of the Prescription Drug User Fee Act. This has enabled them to hire 600 new reviewers and cut review times from 29 to 17 months over the last 5 years. If we fail to act, it means that people who have been working on behalf of the American people will get RIF notices because we have not been as quick to approve FDA reform as we have asked them to approve products that do meet the safety standard. Who benefits from this legislation? Most of all, it is the patients. Safe and effective new medicines will be getting to the patients early. It will meet the performance standards in PDUFA, and we will be able to again provide this great opportunity for patients. By extending PDUFA, we can make further improvements in the drug approval process. Currently, PDUFA only addresses the review phase of the approval process. Our bill expands PDUFA to streamline the early drug development phase as well. This expansion will be covered in a separate letter. This letter is very significant in how PDUFA will work. The letter includes performance goals that have been worked out between FDA and the biological and pharmaceutical industry. What are the kinds of things that this will do that will help? Electronic submissions. It means that instead of a carload, whether it is UPS, IPS, or whatever, pulling up at FDA, with stacks and stacks and stacks of material, it can be done electronically. That not only reduces paperwork, but actually provides a more facile, agile way for the scientific reviewers to get through the data. Also, we are talking about meeting management, in other words, FDA meeting to discuss what are the appropriate protocols; reducing the response time on clinical holds; having written protocol agreements; predictable appeal processes; and reducing manufacturing supplement review times, along with some others. These are management tools, and I cannot understand why the naysayers are saying no to this. I want to make it clear that these goals that we are outlining should be binding on the agency. It is my intent that the letter that will accompany this legislation should be considered as a minimum, not a maximum, commitment. The agency can do better; it should by all means do better. The agency did a great job exceeding its commitments in the 1992 letter along PDUFA compliance. I am sure they can do it this time. Updating the approval process for biotech is another critical component. Biotech is one of the fastest growing industries in our country. There are over 143 biotech companies like that in my own State of Maryland. They are working on AIDS, Alzheimer's, breast and ovarian cancer, other life-threatening infections such as whooping cough. I know during the NIH discussion the other day we passed additional money for Parkinson's. I am proud to report that there is a biotech firm in Maryland that also has a joint venture with brilliant neurological scientists from Johns Hopkins. And we anticipate either a cure for Parkinson's--a cure for Parkinson's--or certainly the ability to stretch out the ability of people to function both intellectually and in terms of their motor skills. You know what? That cure could very well come from Maryland. My gosh, can you understand the joy that I will have the day that I can come to the U.S. Senate and announce that we have found a cure for Parkinson's, that it is in my own home State, and that we have a pharmaceutical that can help people gripped by this devastating and debilitating disease? That is what we are here for. We do not find the cure, but we fund the research to look for the cure. We do not invent the product; that is up to the genius of our private sector working with our scientific community. We cannot ensure the safety and efficacy of that idea to make sure it is not only a dream, but also has the ability to really work in clinical practice in a way that enhances in patients. And that is the job of FDA. But our job is to fund the research and to have the regulatory and legislative framework to evaluate it, to get it out to clinical practice. That is why I am fighting for this. This is exactly why I am fighting for this. My dear father died of Alzheimer's, and it did not matter that I was a U.S. Senator. I watched my father die one brain cell at a time, and it did not matter what my job was. My father was a modest man. He did not want a fancy tombstone or a lot of other things, but I vowed I would do all I can for research in this and to help other people along these lines. And we can go around the Senate. Every one of us has faced some type of tragedy in our lives where we looked to the American medical and pharmaceutical, biological community to help us. When my mother had one of her last terrible heart attacks that was leading rapidly to a stroke--there is a new drug that is so sophisticated that it must be administered very quickly. You need informed consent because, even though it is approved, it is so dramatic that it thins the blood almost to the hemophilia level. I gave that approval because my mother was not conscious enough to do it. Guess what? That new drug approved by FDA, developed in San Francisco, got my mother through her medical crisis with the hands-on care of the Sisters of Mercy in Baltimore at Mercy Hospital. We were able to move that through. Mother did not have a stroke because we could avoid the clotting that would have precipitated it. Thanks to the grace of God and the ingenuity of American medicine, we had my mother with us 100 more days in a way that she could function at home, have conversations with us and her grandchildren. Do you think I am not for FDA? You think I am not for safety? You think I am not for efficacy? You bet I am. And that is what this is all about. It is not a battle of wills. It is not a battle over this line item or that line item. It is really a battle to make sure that the American people have from their physicians and clinical practitioners the best devices and products to be able to administer to save lives. So that is what we are all about. I do really hope that we can approve this FDA reform. I am glad that we invoked cloture, not because I want to stifle debate, but I hope that for whatever ways can be done to improve the bill, let us offer those amendments on the floor, let us have a robust debate, and then let us vote on this, because at the end of next week we will make sure we have had adequate staff to be able to deal with work at FDA and an adequate framework to save lives and generate jobs. So, Mr. President, I thank you for the time. If I seem a little emotional about it, you bet I am. I love FDA. I am really proud they are in my State. I thank God for the ingenuity of the American medical community. And I really look forward to moving the bill. I yield the floor. Mr. JEFFORDS addressed the Chair.

Ms. MIKULSKI

Ms. MIKULSKI. Mr. President, as the dean of the women in the Senate, I rise to pay tribute to the life and legacy of Diana, the Princess of Wales. Our hearts go out to her family and to the British people. We believe it is appropriate that we adopt this resolution to create a national day of mourning on September 6, the day of her funeral. People have expressed surprise at the outpouring of love and grief from the British people. But we shouldn't be surprised. Princess Diana was a remarkable person. We were dazzled by her grace and beauty--but what we truly valued was her compassion. She was called the people's princess. She was born a member of the aristocracy and married into royalty--but she never forgot that Britain's strength was its ordinary working people. The thousands of people laying flowers and waiting in line for hours to sign the condolence book represent a cross section of Britons. They are the senior citizens, the working mothers, the new immigrants--and especially, the children. She treated the people she met with respect and compassion and she taught her children to do the same. Many people go through the motions of doing good works. But with Princess Diana, it came from the heart. The Princess of Wales had her personal challenges. But it is for her public commitments that we will most remember her. She chose her causes carefully. She worked on behalf of those who were most in need. She campaigned for awareness of AIDS and tolerance and compassion for those who suffered from AIDS. She helped support battered women's shelters. She worked on behalf of children's hospitals. She worked to raise money for breast cancer research. These causes were universal in nature and supported by many women around the world. She was also a leader in the effort to end the use of antipersonnel landmines. She traveled to Angola and Bosnia to show the world the tragic effects of landmines on ordinary civilians. By visiting mine fields and landmine victims, she showed us more than any report or international symposium ever could. In the U.S. Senate, Senator Leahy and Senator Hagel have led our effort to end the use of landmines. I am proud to be part of that effort. We have stopped exporting mines, and are now trying to stop their use. The world's most technologically advanced military does not need a weapon that cannot distinguish between a soldier and a child-- who may be killed while playing in a field 10 years after the war is over. Mr. President, Princess Diana's death was a tragedy. But her life was a triumph. Her legacy is her work on behalf of those in need, and, most importantly, her children--whose lives will reflect the values their mother taught them. We can best honor her legacy by continuing to work as she did for those who are most in need.

Ms. MIKULSKI

Ms. MIKULSKI. Mr. President, I am pleased to be able to support the conference reports on the Balanced Budget Act and the Taxpayer Relief Act. Together, these bills will bring us to a balanced budget by the year 2002, while providing vitally important investments in education, in children's health, and in economic development. I believe that my job as the Senator from Maryland and the Senator for Maryland is to save jobs, save lives, and save communities. I believe these bills will help us to do all three. These bills address the day-to-day needs of America's families, and they keep faith with America's seniors. They open the doors to opportunity and give help to those who practice self help. Mr. President, I am particularly pleased that the conferees rejected the unnecessary and harmful structural changes in the Medicare Program. As my colleagues know, I adamantly opposed the means testing of the Medicare program, and the change in the age of eligibility for Medicare from 65 to 67. Such major changes should not be considered without Presidential leadership and a national discussion. I am pleased that these changes were not included in the final budget package. I believe the commission established by this agreement is a better way of addressing the long-term solvency concerns of Medicare. There is much good news for senior citizens in the Medicare portions of this budget. We have ensured the solvency of the Medicare Program for at least the next 10 years. We have provided funds for critical new preventive care benefits, by expanding coverage for mammography and colerectal screening, and by improving self-management of diseases like diabetes. These are investments that will pay off, improving the health of Medicare beneficiaries and saving lives. Having said that, however, I am disappointed with other cuts that these bills make in the Medicare Program. It is disturbing that the Federal guarantee of adequate reimbursement rates to nursing homes has been abandoned. I believe this will put nursing homes in a budget squeeze and will have a negative effect on the quality of care that we provide to our most fragile elderly. I am also disappointed with the excessive cuts in the reimbursement rates for such key services as home oxygen therapy. I believe seniors will be hurt by this change. I hope that we will have an opportunity to revisit these issues in the future. This legislation also will provide a tremendous investment in the health of America's children. The $24 billion provided for health care for uninsured children in this bill is the single largest increase for children's health efforts in over 30 years. Mr. President, there are 10 million uninsured children in this country; 1 in 8 of the children in my own State of Maryland have no health insurance coverage. It is really shameful that we have allowed so many children to be at risk. I believe we have to do all we can to ensure that no child goes without adequate health care. I wish we could have reached every uninsured child with this bill. I pledge to do all I can to work toward that goal. While it does not reach 100 percent coverage for our children, I do believe that this bill makes tremendous strides in the right direction. Over 5 million children who currently have no health care will now get their immunizations, early screening, and other health care services. We have taken a great step in ensuring healthy children who are ready to learn and ready to succeed. I like this budget package because it also opens the doors to education for young people and to people seeking to further their education. The $1,500 HOPE scholarship contained in this bill will help to make available to every student the first two years of college. The tuition tax credit the bill provides for juniors, seniors, and graduate students will enable thousands more young people and returning students to get the education and skills they'll need to succeed in the 21st century. The tax provisions of this package will provide much needed tax relief for working families, for family-owned businesses and farms, and for those who have invested in their homes and communities. This bill is good for those who work hard, play by the rules, and pay their taxes. The child tax credit will provide relief to some 27 million families. When the credit is fully phased in, families with children under 17 years of age will be able to claim a $500 per child credit. We ensure that working families who qualify for the earned income tax credit--who may not pay income taxes but who do pay payroll taxes--will also benefit from the child tax credit. That means we will provide help to families with incomes below $30,000--from the firefighters in Baltimore County to the watermen on the Chesapeake Bay. They work hard, they contribute to our economy and our communities, and they deserve our help. This bill rewards investment and thrift. It will allow Americans who have invested in their communities by the purchase of a home to be able to recoup their investment when they sell that home, without being subject to onerous capital gains taxes. It ensures that people who have built a family farm or a small business with a lifetime of hard work can pass that enterprise on to the next generation. It encourages savings. The bill's new IRA provisions will reward those who practice self help, by increasing access to IRA's, and by allowing withdrawals from IRA's for the first-time home buyers and for educational purposes. Mr. President, this budget package does not provide everything I would like, and I do not like every provision of this package. But I believe overall, this is an agreement well worth supporting. These conference reports finish the job the Congress began in 1993, when the President and congressional Democrats passed the deficit reduction bill. In 1992, our deficit was $290 billion. This year, it will be less than $45 billion. This historic economic plan started us on the road to elimination of our deficit. The bills we are passing this week will finish the job we began in 1993. This is a victory for fiscal responsibility. It is a victory for America's families. It keeps faith with our seniors, opens the doors of opportunity to those seeking an education, protects children's healthy and rewards those who save and who invest. I am proud to support it. duopoly and newspaper-tv cross ownership

Ms. MIKULSKI

Ms. MIKULSKI. Mr. President, I have a question for the distinguished Senator from Alabama and the distinguished Senator from New Jersey concerning discretionary funding for the Interstate 4-R Program. The report accompanying S. 1048 includes language recognizing certain projects that should receive priority attention when the Federal Highway Administration awards discretionary grants. In Frederick, MD, there is a project to upgrade Interstate 70 at its conjunction with Interstate 270, U.S. 15, U.S. 40, and U.S. 340. The complicated interchanges of these two expressways and the other U.S. highways have numerous ramp movements which need to be reconstructed and upgraded in order to provide efficient and safe access. The current interchange forces traffic onto local streets jeopardizing safety for local residents. I ask my colleagues whether they believe the upgrading of I-70 in Frederick would qualify as a project that might receive funds under the Interstate 4-R Program.

Ms. MIKULSKI. I also want to thank the managers for the courtesy and their leadership on this legislation.

Ms. MIKULSKI

Ms. MIKULSKI. Mr. President, I rise in strong support of the Byrd resolution on global climate change and I urge my colleagues to support it. I am proud to be a cosponsor of this resolution. This resolution explains what the ground rules should be if the United States is to become a signer of the United Nations Framework Convention on Climate Change. This resolution would prohibit the ratification of any treaty that would seriously threaten the economy of the United States. It says that both industrialized nations and developing countries must share the burden of any globally binding treaty on climate change equally. I support the Byrd resolution for one simple, but very compelling reason--jobs. For those of you who thought you'd hear a vacuum sound pulling jobs overseas following NAFTA implementation--you ain't heard nothin' yet. The only thing this treaty will do, the way it is written now, is destroy American industry as we know it. I will not be a party to any treaty or agreement that sends American jobs overseas. Business won't have any incentive to maintain or build new factories in the United States. Let me be clear: I support international efforts to improve the environment. But the effort must truly be international if we are to make any progress. I do not believe efforts to control or reduce global warming will be successful unless rapidly developing countries are forced to take the kind of tough steps that the United States will have to take. We cannot be a part of a binding international agreement that lets countries such as China, South Korea, and India off the hook. Developing nations do contribute to global warming. If we exempt them from the restrictions mandated for the industrialized nations, we will simply see a shifting of pollution, not a reduction. This is not what anyone wants to see happen. The objective of the treaty being negotiated is to curb global climate change. The United States has already taken steps to achieve this goal. At the beginning of President Clinton's first term, he released his administration's version of a domestic climate change action plan. This plan relies on a comprehensive set of voluntary actions by industry, utilities, and other large-scale energy users. It also promotes energy efficiency upgrades through new building codes in residential and commercial sectors. Large-scale tree planting and forest reserves are encouraged, as well as increased use of hydroelectric power sources. These are important steps which will have a positive impact on our global climate. We certainly must continue to research causes of global climate change, and come up with scientifically sound solutions. Our viability as a nation and planet depends on it. But we cannot throw away American jobs based on a plan that could have only a marginal impact on climate change. Coming up with the right plan should have little effect on the American economy, because it will mean an overall sustainability of the global environment, and the continuation of the United States as a leader of technological and industrial innovation. Once again, Mr. President, I support this commonsense resolution, which will simply ensure that American jobs won't be lost as we address the issue of global climate change. I am hopeful we can pass this resolution and move on to the next stage of protecting our global environment. I thank the Chair.

Ms. MIKULSKI

Ms. MIKULSKI. Mr. President, I am proud to strongly support and cosponsor the McConnell amendment to restore modest funding for the National Endowment for Democracy. I commend the distinguished chairman of the Foreign Operations Subcommittee for his continued leadership on this important matter. The National Endowment for Democracy is a proven, cost-effective investment in democracy. It represents our national interests and our values. As a member of the Commerce, State, Justice Subcommittee, I am disappointed that no funds were provided for a program that so effectively strengthens democracy around the world. Today we seek to restore funding to continue this important tool of American foreign policy. The cold war may be over--but dictatorships and military juntas still exist. Democracy is still fragile in too many countries. Rigged elections still occur, and freedom of speech is not a universal right. The National Endowment for Democracy provides the tools of democracy. It encourages a free press, unions, and multiparty elections. It supports women's participation in the electoral process. It assists grassroots organizations that support democracy and human rights. The National Endowment for Democracy has a remarkable track record. It was one of the early supporters of the Solidarity movement in Poland. It helped to draft South Africa's constitution. But NED does not rest on it laurels. Today, in Albania, Burma, and Cuba--NED is supporting democracy. It provides assistance to the only independent newspaper in Bosnia. It is helping to empower women in Turkey. It is helping Asian organizations to fight against the use of child labor. Mr. President, the cold war is over--but American leadership is still important. We are still the strongest voice for democracy. I urge my colleagues to join me is supporting the National Endowment for Democracy--one of our most important tools in supporting democracy around the world. Mr. GRAHAM addressed the Chair.

Ms. MIKULSKI

Ms. MIKULSKI. Thank you very much, Mr. President. I think that is a prudent course in which to proceed. The full committee markup was delayed because the committee was late going into session because of our moving ahead on military construction. I do want to speak about the space station and began my remarks at the conclusion of the Senator from Arkansas's proposal. But, Mr. President, before I give my remarks, what is the pending business before the Senate?

Ms. MIKULSKI. Mr. President, first of all, I thank the Senator from Colorado for not pressing for a vote on this amendment, how to use the taxpayer's dollar to really create not only opportunity in public housing but also how we can end the cycle of poverty, the culture of poverty, and for public housing to be a way to a better life. I am glad the authorizers are going to consider the bill. I look forward to listening to the recommendations. I know the senior Senator from Maryland is the ranking member and we will have many spirited discussions. So how best to provide for the poor, particularly also the working poor, is, indeed, a great challenge. We do not want to repeat mistakes in the future, but we also do not want to create new mistakes in the future. So the authorizing bill is a great way to do it. I thank the Senator from Colorado for his spirited advocacy and also for withdrawing the amendment. I yield the floor. The amendment (No. 947) was withdrawn.

Ms. MIKULSKI. Mr. President, what a moving story, what a moving story to hear about the Forgotten 216th. I am sure that this has been a considerable heartbreak for every member of that unit who went to ground zero. I am sure they went with good faith in themselves and in their Government, and yet over the last 45 years, they have endured terrible blows from their Government--one, the blow of exposing them to intense radiation with no protective gear; the second, that for 45 years, the very validity of their concerns about what happened to them and their need for medical treatment were, again, rejected by their U.S. Government. I thank the Senator for this type of amendment, because I will tell you today, I didn't want to, because of a budget situation, have to vote to reject them one more time. I think just as you have heard now from the chairman of the committee, we are going to take your amendment. We like your amendment, and I will tell you why we like your amendment. One, we are going to get to the facts about what this will cost, because too often, as the Senator from Minnesota knows, compelling human need gets all entangled over cost. This way we will know the cost. But then by asking the Veterans Affairs Committee to hold hearings within 60 days, it is a bit of a hammer, if you will, to ensure that there will be, as in our democracy, a public hearing on this. I say to my colleague from Minnesota that it has been my observation in 20 years--10 in the House and now over 10 in the Senate--that the VA, when it came to compensation for what our veterans were exposed to, never acted on their own. They only acted because Congress pushed for the facts. I thank the Senator from Minnesota for pushing for the facts in terms of this situation, the facts on cost, the facts on what happened to them, and the facts on the consequences to these veterans and how we need to address them. I say to my colleagues in the VA, not the committee, but in the Veterans' Administration, if you are listening to the debate, don't see this as a problem; see this as an opportunity, because here we can have one of the most unique longitudinal studies of what happened to men who were fit for duty when they walked at ground zero, and then what were their health consequences to both themselves and to their beloved wives, as well as to their children and their grandchildren. What a unique opportunity for both veterans, the Centers for Disease Control, and even NIH to welcome these men, to embrace these men as we try to redress the grievance that happened to them, and the lessons learned so that we then know what radiation did to people and offer insights that could help other people who have been exposed to radiation. So I thank the Senator for his amendment. I thank the Senator for his advocacy in this area. I look forward to accepting the amendment, and I look forward to hearing the CBO and the VA Committee's report. Mr. WELLSTONE addressed the Chair.

Ms. MIKULSKI. I move to lay that motion on the table. The motion to lay on the table was agreed to. Mr. BOND addressed the Chair.

Ms. MIKULSKI. Mr. President, I rise to offer an amendment on behalf of myself and Senator Daschle. I send the amendment to the desk.

Ms. MIKULSKI. Mr. President, I ask unanimous consent that the reading of the amendment be dispensed with.

Ms. MIKULSKI. Mr. President, I wish to bring to my colleagues' attention that this amendment is Mikulski-Daschle-Bond amendment. It is being offered in concurrence with the chairman of the committee. What this does is provide funding for empowerment zones, the ``America Reads'' initiative and FEMA disaster mitigation. I want to note that the money that we provide is indeed a modest fund, but it, indeed, enables us to state that these are three priorities we wanted to consider in the appropriations, that we would have normally had a larger funding had the budget agreement not given us such a skimpy allocation. What does this amendment do? It provides $25 million to HUD for a new round of empowerment zones and enterprise communities. It also provides $20 million for the America Reads initiative at the Corporation for National Service. And it provides $5 million for FEMA's predisaster mitigation program. Mr. President, while this amendment provides funding for these three separate programs, we must remember that each of these three programs have in common, namely, that they really do directly assist the residents of our Nation with their day-to-day needs. First, Mr. President, this amendment, in providing $25 million for a second round of empowerment zones and enterprise communities, would promote job creation and economic development in economically distressed urban and rural areas. I am sure that we would all agree this is a critical need. Unfortunately, probably every Senator here has an area in their State that is economically distressed--urban, rural, or both. The first round of the program covered American communities of which 72 urban and 23 rural communities were either designated empowerment zones or enterprise communities. Mr. President, what this money actually goes for, though, is job creation, economic development, job training, and empowerment of local residents. The empowerment zone is not a quick fix, but it does offer opportunity and hope. In the area of America Reads, this amendment also provides $20 million for the America Reads initiative. This money would support 1,300 additional Corporation members who would serve as tutor coordinators. These tutor coordinators would provide direct tutoring and help mobilize and coordinate thousands of tutors to work with young children across the country. What is the purpose of the America Reads initiative? It is to help with local school systems to make sure that every child in the United States can read by the time they are in the third grade. It is the administration's policy, and I know supported on a bipartisan basis, that we want to see every child in the United States of America immunized by the time they are 2, screened and school-ready by the time they are 6, can read by the time they are in the third grade, and know how to use and have access to a computer by the time they are 12. That would enable our children to be ready for the 21st century. But let us be clear. It is not the Federal Government's job to supplant local school systems. What the America Reads initiative does is mobilize volunteer efforts, provide the infrastructure to be able to greatly utilize volunteers and, in addition to local school efforts, to help our kids read. In no way will it supplant local school efforts nor local school board policies. So it will be one of the better of the Federal and local partnerships. Mr. President, also, let us turn to Federal predisaster mitigation. I note that the Presiding Officer is from Pennsylvania. We have sure lived through a lot of floods the last 2 years. And it has been wonderful when FEMA has been able to respond ``911'' to our States. I know what Missouri endured, what our colleagues in the Dakotas and 12 other States did. But, you know, some Federal funds used wisely could actually prevent damage to either personal property or small business if we did some infrastructure planning. What this amendment does is provide $5 million for predisaster mitigation activities at FEMA. Last year, we provided $2 million for a pilot program identifying communities that could benefit from the money and build on it. Mr. President, this is a modest amount of money, but I believe will help tremendously in the future. In California, if we insist that earthquake standards are met, it then saves money when an earthquake hits. In Dade County, the officials there have a mitigation program to protect structures against hurricane force winds. And in my own State of Maryland, we had a unique partnership between the Governor of the State of Maryland and the Corps of Engineers to do a flood mitigation task force up in western Maryland where Pennsylvania and West Virginia coincide, and, in the area of the great floods, collided. So, Mr. President, this modest amount of money would really go a long way in helping us assess what we need to do to protect small business and personal property. An ounce of prevention is worth a pound of cure, and I believe a dollar's worth of prevention will ultimately help us save $100 in disaster relief. Mr. President, as I stated, this amendment provides funding for three important programs: First, the amendment provides $25 million to HUD for a new round of empowerment zones and enterprise communities. The amendment also provides $20 million for America Reads Initiative activities at the Corporation for National Service. And the amendment provides $5 million for FEMA's predisaster mitigation program. Mr. President, while this amendment provides funding for three separate programs, we must remember what each of these programs have in common, namely, they all aim to directly assist residents of our great Nation. First Mr. President, this amendment would provide $25 million for a new round of empowerment zones and enterprise communities administered by the Department of Housing and Urban Development. The first round of empowerment zones were awarded in December 1994. The goal is to promote job creation and economic development in economically distressed urban and rural areas. I am sure we would all agree this is a critical need. Unfortunately, probably every Senator in here has an area in their State that is an economically distressed area--urban, rural, or both. The first round of the program covered a wide range of American communities. Seventy-two urban areas and 33 rural communities were designated empowerment zones or enterprise communities. There are currently eight urban empowerment zones and three rural empowerment zones. There are also 4 enhanced enterprise communities and 93 enterprise communities. Each empowerment zone received $100 million--Los Angeles received $125 million. Cleveland $90 million--each enhanced enterprise community received $25 million, and the 93 enterprise communities received $3 million. This money can be used for job creation and economic development activities--such as building renovations and infrastructure improvements. The money can also be used to provide services such as child care, job training and transportation for residents in the zones. In addition to the grant money, in each empowerment zone and enterprise community, employers are eligible for wage tax credits worth $3,000 for every employee hired who lives in the empowerment zone. The program is not just about moving employees from one location to another, it is also about providing employers incentives to help unemployed and underemployed zone residents. We are talking about a hand up, not a hand out. The tax credit provision is designed to provide an opportunity structure, a chance to work hard and earn a decent living. Empowerment zones and enterprise communities are also eligible for various other benefits including tax-exempt bond financing and tax writeoffs for depreciating personal property. Mr. President, the empowerment zone program is not a quick fix. Many of the communities are ones that have suffered for years from high unemployment, high crime, and other problems. The program is a 10-year effort that required partnerships between community residents, local and State governments, and local businesses. A recent GAO report noted that the zones have made some progress. The report notes that there is still work to be done, but the effort is progressing. The key is that the program is making progress and its deficiencies are ones that can be addressed. In its own assessment of the empowerment zones and enterprise communities, HUD notified five communities that they were not making sufficient progress. These communities risk having future funding withdrawn. The point is that this is not some HUD program run wild. There are standards and expectations that are being measured. Mr. President, the empowerment zone program is a good mix of Republican and Democratic ideas--tax incentives to leverage private dollars and community involvement in decisionmaking. Mr. President, this amendment also provides $20 million for the America Reads Initiative at the Corporation for National Service. This money would support approximately 1,300 additional corporation members who would serve as tutor coordinators. These tutor coordinators would provide direct tutoring and help to mobilize and coordinate thousands of tutors to work with young children across the country. The America Reads initiative is an administration effort that is truly worthy of bipartisan support. The goal is simple--every child in the Nation should be able to read independently and read well by the third grade. A simple, yet key goal in the effort to ensure that every child is equipped with the basic tools needed to compete in the 21st century. Mr. President, in 1994, 40 percent of fourth graders failed to attain the basic level of reading on the National Assessment of Educational Progress. This is a fact that we can't ignore and must address. Let me be clear, the reading deficiencies of our Nation's children won't be erased with volunteer tutors. There are issues of education funding and the delivery of education that need to be addressed. I am under no illusion that the America Reads initiative is the only answer. But Mr. President, I don't want us to make the perfect enemy of the good. The America Reads initiative is part of the answer. A Cohen, Kulik and Kulik analysis of 65 published studies showed that quality tutoring programs produced positive, though modest effects. Other studies done in Florida and England have found similar results. Mr. President, modest is in the eye of the beholder. If I am rich and only see a modest return on my stock investment, I may be disappointed. But if I am a child who can't read like I should be able to, and someone helps me improve my reading modestly so that I can understand words on a page, I am probably very happy with my modest gains. Mr. President, there have been many debates about the corporation for National Service. This amendment moves beyond that debate. The program will be funded and will continue to operate. This amendment seeks to provide some additional funding to support corporation activities that I am sure we all agree are worthwhile. Finally Mr. President, this amendment also provides $5 million for predisaster mitigation activities at FEMA. Mr. President, I don't know if there is a clearer example of ``an ounce of prevention is worth a pound of cure.'' To put it in appropriations terms one might say that ``a dime of prevention is worth a dollar of cure.'' Currently, FEMA provides postdisaster mitigation money to communities--up to 15 percent of the amount they received for disaster recovery efforts. This money is important and necessary, but its' flaw is that it comes after a disaster has struck. Last year, the VA-HUD bill provides FEMA $2 million to begin a pilot program identifying communities that could benefit from predisaster mitigation money. This amendment seeks to provide money that would expand on that effort. Unfortunately, every Senators' State has likely placed a ``911'' call to FEMA. Many times, there is nothing that we can do to escape nature's fury. However, all to often, there are things that we can do to reduce the risk to life and property. From making sure buildings meet proper standards to moving structures out of high-risk areas, there are things we can do. Retrofitting a bridge in California to meet earthquake standards costs about $31 a square foot. Replacing a bridge that didn't meet standards would cost about $135 per square foot. In Dade County, FL, officials have a mitigation program designed to protect structures from hurricane force winds. A cost-benefit analysis showed that for every $1 dollar in mitigation money invested to protect an emergency housing center, $5 in future damage relief costs are likely saved. Mr. President, there are other examples I could site. The point is that the predisaster mitigation program is ultimately about saving lives, saving communities, and saving taxpayers' money. Mr. President, I urge my colleagues on both sides of the aisle to support this amendment. It is designed to help provide opportunity structures and economic development for our Nation's distressed urban and rural communities through the empowerment zone and enterprise communities program. The amendment also provides support for the critical America Read initiative--designed to help ensure that all of the Nation's children can read properly by the fourth grade. Finally, the amendment provides support to a predisaster mitigation program designed to save lives, save communities and save taxpayers' money. Mr. President, I believe this amendment addresses concerns that transcend party lines. It is designed to support programs that directly impact the citizens of our Nation. I want to especially thank Senator Daschle for his support, and Senator Bond for his willingness to work with me on this important effort. I urge my colleagues to support this amendment. Mr. President, I hope that we can move expeditiously and adopt this amendment and make a great step forward in giving empowerment and help to our local communities. Mr. BOND addressed the Chair.

Ms. MIKULSKI. Let us move for its adoption.