Jim Jeffords

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I rise today with Senator Snowe to introduce legislation to aid the growth of commerce throughout New England. The Older Industrial Region Rail and Port Access and Modernization Act aims to improve northern New England's aging rail infrastructure and ocean ports to speed delivery of goods and people throughout the region. New England was built by the railroads. But in our modern economy, highways have captured a majority of the commerce, supplanting rail. As we reach the end of this century, our region has begun to recognize the importance of railroads, and their vital role in our expanding economy. Efficient highways run north to south in northern New England, but we have no east to west roads sufficient to handle growing trade and commerce. As Vermont, New Hampshire, and Maine work together to compete in this global economy, our success is dependent on our mutual efforts to improve access to markets. We will succeed only if modern freight railroads can serve the entire region and through our ports bring goods to market across the Nation and around the world. Rail lines throughout northern New England have been neglected for many years. Crumbling rail beds and constricted passage has limited the movement of freight and passenger trains and restricted rail access to deep water ports. Older bridges, deteriorated tracks, inadequate tunnels all contribute to a rail system that fails to fulfill the needs of the three-State area. As a result, commerce throughout the region suffers. A recent report by Cambridge Systematics, entitled ``New England Transportation Initiative,'' indicates that northern New England's economy cannot fully expand without a carefully planned and implemented intermodal strategy. The study predicts that Maine's ports will gradually lose business to southern ports, primarily in New Jersey and New York, because of inadequate rail transportation and port access. In addition, the study predicts that business and jobs in New Hampshire and Vermont will not keep pace with other regions without a better strategy to efficiently move goods and people. An exhaustive analysis by the Eastern Border Transportation Coalition regarding the trade and traffic flows across the eastern United States- Canada border projected a trade increase of close to 200 percent by the year 2015. The report also outlines that this increase could be hampered by a lack of adequate transportation options and overcrowded roads and highway border stations. To avoid this setback, rail options must be available. Without proper infrastructure development, New England's chance to take advantage of such economic growth will diminish. The legislation we introduce today will authorize Federal spending to rehabilitate rail beds in Vermont, Maine, and New Hampshire, enabling them to improve their freight rail traffic and better handle the movement of goods and people with their borders. States will be able to apply separately to the U.S. Secretary of Transportation for individual grants. Grant funding is provided for a variety of categories: Port development and access; bridge and tunnel obstruction repair and replacement; repair of railroad beds; and development of intermodal facilities, including intermodal truck-train transfer facilities. Revitalization of these resources will allow freight and passenger trains to move freely throughout the region, reconnecting railroad towns long separated by the hazards of unpassable tracks. The bill also establishes a loan assistant program. Railroad companies in Vermont, Maine, and New Hampshire will be able to access low interest loans to improve their rail lines in the region. The loans can be used for purchase of rolling stock, development of maintenance facilities, and many other capital improvements. Without this legislation, Vermont, New Hampshire, and Maine may fail to benefit from future growth opportunities. Even though international shipping trade is expected to increase by 20 percent in the next 5 years, New England is less likely to benefit from the influx of business and jobs because of its decaying rail and port infrastructure. Improving rail lines will bring new life to our region, strengthening our industries and thereby our economies. Mr. President, I would urge action on this legislation, because, as we are learning, ports and railroads are the life lines that will help to ensure the well-being of all of northern New England.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I would be happy to enlighten the body as to where we stand. It is my understanding we have an agreement. However, it appears an objection will be raised if we try to move forward at this time. So, I would just alert everyone that I believe we have an agreement and that we will be able to move forward this week. There are, as is always the case when you go to bring a measure forward, people who decide suddenly they want to be involved in the process. We will try to accommodate them. I know there are several Members who are out of the country right now and will be back later today. So, I don't intend to call up the FDA Act at this time, but I will, with the indulgence of the President, move forward, I suppose as in morning business, and discuss where we are on the bill.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I would like to announce for information of the Senate and the public that a hearing of the Senate Committee on Labor and Human Resources will be held on Tuesday, July 29, 1997, 9:30 a.m., in SD-430 of the Senate Dirksen Building. The subject of the hearing is improving educational opportunities for low-income children. For further information, please call the committee, 202/224-5375. committee on rules and administration

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I ask unanimous consent that Sean Donohue and Chris Loso, fellows with the Committee on Labor and Human Resources, be permitted the privilege of the floor during all Senate consideration of S. 830, the Food and Drug Modernization and Accountability Act.

Mr. JEFFORDS. I am not proceeding to the bill at this time. I am hopeful and wait patiently with great expectations that at some point after having discussed with you and perhaps communicated with the minority leader that we will be able to move forward with the bill in a way that will utilize the time today effectively so that we can complete this bill by the end of the week. But I do not intend to call it up at this particular moment.

Mr. JEFFORDS. The bill itself has been ready for about a month and has been under examination for a month. In order to be able to proceed most efficiently and effectively in the amendment process, we have been working with Members--and you have asked us to do so today--to take into consideration possible changes in the bill. We had many requests of that nature over the past month, and we have accommodated, to my knowledge, every one of those requests and have been and are ready to proceed, with the understanding that certain amendments would be offered. Some of those amendments would be accepted and some of those would be disagreed with. But we are under the exigencies of time here. This is such an important bill. We started negotiations, the Senate did, last year, under Senator Kassebaum. The bill was voted out of the committee by a very substantial vote. However, there were strong objections raised to it and problems with the House. So we started again this year with the bill and we have been working for several months, now, ironing out these difficulties and problems. It was my understanding we had a consensus. That is why we are here on the floor this afternoon. On the other hand, now we understand that some others have reasons that they would like to participate. We have no problem with that. The problem is not ours, in the sense of the committee. The problem is time on the floor. We have just 1 week left before we go into recess in order to accomplish the major bills, the reconciliation and budget matters, and we will have only a limited amount of time. So, for us to proceed and get this finished by the end of the week, which is important, it is going to take agreement by those who now want to participate in order to have a timely process where we can bring this to conclusion. I look forward to working with my colleague--I know he will cooperate with us so that this very important piece of legislation can get passed out. The House is waiting to move until we move. Also connected with it is the Prescription Drug User Fee Act, PDUFA, which is very important to get passed because that expires at the end of September. So we must move ahead. I thank the Senator for giving his time.

Mr. JEFFORDS. If the Senator will yield?

Mr. JEFFORDS. Mr. President, I, again, want to thank Doctor --Senator Frist who is a cosponsor of this bill and has lent his incredible expertise to this effort. I especially thank him for his leadership, with Senators Mack, Boxer, and Wyden, for their work in solving the off-labeling provision. Their collaboration shows the broad base of support this provision now has. Off-labeling was one of the most contentious provisions in the last Congress. To come up with a solution of that issue is a tremendous step forward. I want to talk a little bit, before I wind things up here, about the broad base of support we have. Senator DeWine, for instance, joined with Senator Dodd in offering important amendments to establish incentives for the conduct of research into pediatric uses of existing and new drugs. Senator Hutchinson had an amendment to establish a national framework for pharmacy compounding with respect to State regulations which allowed us to move forward on another very contentious and important issue. I also want to praise and thank Senator Mikulski for being a cosponsor of this legislation, and the importance of her help on PDUFA, of which she was a primary sponsor. We all benefit from Senator Mikulski's determination to bring FDA into the 21st century, not just for the benefit of her own constituents, but for all of us. I also would like to point out that we had contributions by Senator Dodd in the area of patient databases. He worked very closely with Senator Snowe and Senator Feinstein. We are grateful for their leadership in these areas. Senator Dodd has been a tremendous asset in helping to enact broad-based reform this year. He has been of steady, continual assistance to us. Also, the tremendous difficulties that we had with third-party review provisions during the last Congress have undergone substantial revision since it was first debated. Senator Coats in particular has shown incredible leadership on this issue. This was a very difficult area and Senator Coats has been magnanimous in his willingness to spend many hours in bringing about consensus. I certainly appreciate his work. Senator Wellstone's contributions to the area of reforming medical device reviews shows the breadth of the philosophical collaboration we had on these issues. Senator Wellstone introduced his own legislation to reform the medical devices approval process and many of his provisions are included in this bill. Also, of course, Senator Kennedy has been of incredible help, as he has been on so many issues. He has worked hard and I thank him for the number of hours that he and his staff put into this bill to make sure we arrived at a consensus. I also thank Senator Gregg for working so hard on radio- pharmaceuticals, on streamlining the process for reviewing health claims based on Federal research, and on establishing uniformity in over-the-counter drugs and cosmetics. The latter issue--cosmetic uniformity--is still giving us some trouble. But Senator Gregg has just been incredibly hard-working and effective with this bill in handling four different issues. Also, the two amendments that Senator Harkin had on the third-party review for medical devices and also his work in other areas has been a very great help and a demonstration of the broad philosophical support that we have and how we are working together to bring about a consensus, hopefully, before the end of the day on the remaining issues. Mr. President, before I cease, I would like to take care of a couple of housekeeping matters here.

Mr. JEFFORDS. Mr. President, first of all, I want to thank the Senator from Oregon for his support and for his very effective presentation. I know there are so many of us here who want to work together. In fact, just about everybody does. That is why it is of such concern to me that we now find ourselves in a position where we can't proceed. I know of the Senator's immense assistance in helping us in this matter, and I appreciate what he has said. Mr. President, I think it would be wise at this point, while we are biding time in the hopes of being able to move forward, to answer the questions that many people have: Why are we here? What is the big deal? What is so important? Why are we anxious to get moving and to get this piece of legislation passed? I would like to go through some of the problems that we have right now with the FDA because it is our lives and our health that are at stake here. The time delays that occur because of the various problems at the FDA that we are trying to correct mean that new therapies that would be essential to your life and health, proceed so slowly that many, many people are deprived of the hopes and dreams we all have of a good health and a good life. Let me provide some examples. By law, FDA is required to review and act on applications for approval on drugs within 180 days. Now, that 180 days was not just pulled out of the air. That was looking at the normal processes you would be able to do it in 180 days. According to FDA's own budget justification for fiscal year 1998, it takes the agency an average of 12 months longer than the statute allows to complete this process. It takes, on average, a year and a half for a process that should take 6 months. Since the 1960's to the 1990's, complete clinical trials, that is, the time required by FDA to show for efficacy of drugs, has increased from 2.5 to nearly 7 years. Between 1990 and 1995, the FDA average approval time, that is, the time after the clinical trials have been completed, was about 2.3 years. Today, only 1 in 5,000 potential new medicines is ever approved by the FDA. According to a recently published study, from the beginning of the process to the end, it takes an average of 15 years and costs in the range of $500 million to bring a new drug to market. Why does this process take so long? Before FDA even gets involved in the process, innovators spend an average of 6\1/2\ years in early research and preclinical testing in the laboratory and with animal studies. Long before human tests begin, a summary of all the preclinical results is submitted to the FDA. This document, known as the investigational new drug application, or IND, contains information on chemistry, manufacturing data, pharmacological test results, safety testing results and a plan for clinical testing in people. If the FDA judges the potential benefits to humans to outweigh the risks involved, the stage is set for three phases of clinical trials to begin. Taken together, the three phases of clinical trials in human populations average about an additional 6 years. Phase I clinical trials focus on safety. During about a 1-year period, very low doses of compound are administered to small groups of healthy volunteers. Gradually, they are increased to determine how the bodies react to the different levels. Phase II clinical trials last about 2 years; that is, 2 additional years. They involve 100 and 300 patient volunteers, and focus on the compounds effectiveness. These are blinded trials that are held in hospitals around the country where they compare the innovator compound with a so called placebo--that is the control group is not given anything. The effect of the innovator drug is compared with effect on those who received the placebo. Three out of four prospective drugs drop out of the picture as a result of the data collected during these phase II trials. Phase III trials involve one or more clinical trials where researchers aim to confirm the results of earlier tests in a larger population. Phase III lasts from 2 to 5 years and can involve between 3,000 and 150,000 patients in hundreds of hospitals and medical centers. These tests provide researchers with a huge database of information on the safety and efficacy of the drug candidate to satisfy FDA's regulatory requirements. The amount of data required to file for the next new phase, new drug application, or NDA, is staggering. The application for new drugs typically runs to hundreds of thousands of pages in length. For example, in 1994, the NDA for a groundbreaking arthritis medication contained more than 1,000 volumes of documentation that weighed 3 tons. It included data from clinical tests in roughly 10,000 patients, some of whom had been taking new medication 5 years. During the NDA review process--which can last an additional 2\1/2\ years, Government officials have extensive contact with the company. They visit the research facilities and talk to the doctors and scientists involved in the research. In addition, FDA officials visit and approve the manufacturing facilities and review and approve all the labeling, packaging and marketing that will accompany the product. Well, that is good and we want the FDA to be thorough, but things can be done more efficiently and more effectively. If we cannot reduce these times based on the consensus agreements in this bill--then a lot of people will lose the timely availability and the utilization of these breakthroughs. What does this reducing of overall time mean for Americans? If we can reduce this overall time, it means quicker access to safe and effective lifesaving drugs. I want to point out that the FDA, when it reviewed priority applications, has been able to make breakthroughs in AIDS and elsewhere by just being more efficient. Also, for instance, to give you an example of review process delay, over 12 million type-2 diabetics had to wait almost 2 years for a new machine to be approved. Almost 2 million American women with breast cancer had to wait almost 2 years in excess of what should have been required for this review process. So when that you have that kind of delay, you know you have to have reform, and that is why we are here. Some may argue that the long period of review and approval time is the price we pay for ensuring drug safety and efficacy. But that long delay does not hold true for all drugs. We know the FDA can significantly reduce its approval times because it has already done it. We have, for instance, with respect to the AIDS therapies, the so-called protease inhibiters that were approved in a matter of months. FDA can do more to ensure that they receive timely attention, and S. 830 will help FDA do so for all promising therapies. FDA is aware of this, and that is why they have been working to help simplify the law, simplify the process, simplify the procedures, so that we can get these drugs to market on time without in any way infringing upon the necessity to protect the health of our people. So as we proceed, I will review these issues in a more definitive manner. But as we await removal of an objection to proceed, I just wanted to remind people that there are real, valid, deep concerns that we are facing here. Our goal is to make sure the health of our Nation can improve and that people will be able to have access to the innovative therapies that will benefit their lives. Mr. President, I yield the floor. Mr. FRIST addressed the Chair.

Mr. JEFFORDS. Mr. President, as we have just discussed, I am going to proceed so that my colleagues and those interested in this legislation can better understand the nature of this legislation and the importance of it, and, hopefully, later in the day, we will be able to proceed in an orderly manner through the amendment process. The legislation is to modernize the Food and Drug Administration, and we authorize the Prescription Drug User Fee Act, which will, upon enactment, streamline the FDA's regulatory procedures. This modernization will help the agency review medical devices and drugs more expeditiously and will let the American public have access sooner to newer, safer and more effective therapeutic products. I am disappointed that some of my Democratic colleagues are not desirous of proceeding at this time, but I will do my best to accommodate them and also to move forward on this bill. I am especially chagrined, given the months of bipartisan negotiating that has led to this bill. Each major provision--all of the drugs and medical device provisions of this measure--represents long-sought agreements with the minority and with the FDA itself. I do not understand this continued delay. In particular, Senator Kennedy has played a key role in reaching this agreement, and I wish to applaud his willingness and tenacity in working through several difficult issues to reach a consensus on this legislation. In addition, Secretary Shalala and the FDA itself has worked diligently to reach reasonable, sensible agreements. This is a good, bipartisan measure that represents moderate yet real reform. It has been agreed to by the minority and the administration. There is no reason for further delay, and I am going forward today with the expectation that before the end of the day, we will be moving forward on this bill. On June 11, prior to the committee markup of S. 830, I received a letter from Secretary Shalala outlining the Department's key concerns. This was sometime ago. In her letter, the Secretary stated: I am concerned that the inclusion of nonconsensus issues in the committee's bill will result in a protracted and contentious debate. Before and since our committee markup, we have worked hard to achieve a consensus bill. The measure before us today accomplishes that goal. Bipartisan staff and Members have worked diligently with the agency to address each of the significant nonconsensus provisions raised by the Secretary. In her letter, Secretary Shalala expressed her feeling that the legislation would lower the review standard for marketing approval. Key changes have been made to the substitute to address these concerns. With respect to the number of clinical investigations required for approval, changes were made to assure that there is not a presumption of less than the two well-controlled and adequate investigations, while guarding against the rote requirement of two studies. We made it very clear you don't have to do two, although it is quite acceptable for you to do two, but you shouldn't look at it as being required. It is not necessary. The measure clarifies that substantial evidence may, when the Secretary determines that such data and evidence are sufficient to establish effectiveness, consist of data with one adequate and well- controlled clinical investigation and confirmatory evidence. Concerns were raised also about allowing distribution of experimental therapies without adequate safeguards to assure patient safety or completion of research on efficacy. Changes to accommodate those concerns were made. They are in the substitute. We tighten the definition of who may provide unapproved therapies and gave FDA more control over the expanded access process. Other changes will ensure that use of products outside of clinical trials will not interfere with adequate enrollment of patients in those trials and also give the FDA authority to terminate expanded access if patient safeguard protections are not met. The provision allowing manufacturers to charge for products covered under the expedited access provision was deleted also. In mid-June, the Secretary argued that S. 830 would allow health claims for food and economic claims for drugs and biologic products without adequate scientific proof. In response, Senator Gregg agreed to changes that would allow the FDA 120 days to review a health claim and provide the agency with the authority to prevent the claim from being used in the marketplace by issuing an interim final regulation. In addition, the provision allowing pharmaceutical manufacturers to distribute economic information was modified to clarify that the information must be based on competent and reliable scientific evidence and limited the scope to claims directly related to an indication for which the drug was approved. This bill was further changed to accommodate the Secretary's opposition to the provision that would allow third-party review for devices. Products now excluded from third-party review include Class III products. These are products that are implantable for more than 1 year, those that are life sustaining or life supporting, and also products that are of substantial importance in the prevention of impairment to human health. In addition, a provision advocated by Senator Harkin has been incorporated that clarifies the statutory right of the FDA to review records related to compensation agreements between accredited reviewers and device sponsors. I want to point out that we have been working hard with Members, the Secretary, and others who brought problems to us, and we believe we have all of those taken care of, but we understand now we will have to do some more work today. Finally, the Secretary was concerned about provisions that she felt would burden the agency with extensive new regulatory requirements that would detract resources from critical agency functions without commensurate enhancement of the public health. This legislation now gives FDA new powers to make enforcement activity more efficient, adds important new patient benefits and protections, and makes the review process more efficient. First, we give FDA new powers and clarify existing authority, including mandatory foreign facility registration, seizure authority for certain imported goods, and a presumption of interstate commerce for FDA-regulated products. Those are all important changes to help clarify the powers of the FDA. Second, to assist patients with finding out about promising new clinical trials, we established a clinical trials database registry, accessed by an 800 number. Patients will also benefit from a new requirement that companies report annually on their compliance with agreements to conduct postapproval studies on drugs. This was an important provision that we added, working with Senator Kennedy. Third, FDA's burden will be eased by provisions to make the review process more collaborative. Collaborative reviews will improve the quality of applications for new products and reduce the length of time and effort required to review products. We also expressly allow FDA to access expertise at other science-based agencies and contract with experts to help with product reviews. This is very important to bring about more efficient and effective utilization of resources. Lastly, by expanding the third-party review pilot program for medical devices, we build on an important tool for the agency to use in managing an increasing workload in an era of declining Federal resources. In closing, I echo another part of Secretary Shalala's June 11 letter: I want to commend you and the members of the committee on both sides of the aisle on the progress we have made together to develop a package of sensible, consensus reform provisions that are ready for consideration with reauthorization of the Prescription Drug User Fee Act. . . a protracted and contentious debate . . . would not serve our mutual goal of timely reauthorization of PDUFA and passage of constructive, consensus bipartisan FDA reform. I can't tell you how pleased I am that we have been able to work with the Secretary and come to this point now where we have few--I don't believe we have any disagreements--with the Secretary. Although we have some further matters we may have to discuss. From the beginning of this process, all of the stakeholders have been committed to producing a consensus measure, and we have accomplished that goal. There is agreement on this bill, and I urge my Democratic colleagues to allow this important measure to move forward. Before yielding the floor, I would like to commend the members of the committee. I have never worked with a group that has worked as hard as the members of my committee have to bring about a consensus. This has been night-and-day work for weeks. We have some outstanding Members on both sides of the aisle that have done outstanding work to bring us to this point. I could name them all, and I will eventually as we go forward, but I know standing and ready to go is one of those who has been of invaluable service to this committee. That is Senator Frist. With his knowledge as a physician, his intelligence and ability to communicate in a way that brings about consensus, we have moved forward on some incredibly important goals for being able to assist our doctors in their pursuance of good health for all of us. With that, Mr. President, I yield the floor. Mr. FRIST addressed the Chair.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the resolution be agreed to; that the motion to reconsider be laid upon the table; and that any statements relating to the resolution appear at the appropriate place in the Record.

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the Senate proceed to the immediate consideration of Calendar No. 130, SEnate Concurrent Resolution 33.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the Senate stand in recess until the hour of 3 p.m.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the resolution be agreed to; that the motion to reconsider be laid upon the table; and that any statement relating to the resolution appear at the appropriate place in the Record.

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the Senate proceed to the consideration of House Concurrent Resolution 123, which was received from the House and is agreed upon by both parties.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I am introducing legislation today, pursuant to many recent discussions about the rescue plan for the District of Columbia, that reaffirms my strong belief that education must be the keystone of that plan and that fair and ready funding is available with no cost to the Federal Government. Every Washington area citizen should keep a careful watch on what Congress is doing to rescue the Capital from its present plight. The chorus resounds, ``we must get people to move back into the Capital! Its future depends on it!'' But if we examine the present congressional and administration plans and overlay them onto the root causes for the plight, serious questions arise as to their effectiveness. Studies indicate that the two leading causes, by far, that cause people to leave the District and keep them from living in the city are poor schools and high incidents of crime. Let's examine the plans that Congress has before it. Only the Senate plan as currently outlined even mentions education and that is basically a symbolic gesture to help repair the crumbling school infrastructure. The administration does consider the crime problem, but only at the end game of taking over the prison system. The administration's plan has no mention of repairing the failing D.C. educational system; a system which is among the worst in the Nation. The central administrative problem of the District's school system is not money, it is management chaos. But money is a serious concern in the area of school infrastructure, and D.C. has one of the worst school infrastructures in the Nation. In fairness to General Becton, the new chief executive officer for the schools, he is trying valiantly to upgrade overall standards but too much of his time is spent dealing with emergency school infrastructure repairs. Again this September, 43 schools will be threatened with closure at the outset of the academic year. Over $2 billion are needed just to fix building code violations. Crime in the District is directly related to the public school system. Some 40 percent of D.C. children drop out of school between grades 7 and 12. National studies show that about 80 percent of prison inmates are school drop-outs. A plan to help D.C. must have a strong component to improve education. As will be shown below, this need not carry a significant dollar cost to the Federal Treasury. In fact it will save millions. The President wants to be known as the Education President. Congress wants to be known as the Education Congress. Wouldn't the best demonstration of that intent be to start by improving the education system of the Nation's Capital? The present plans for enhancing a middle-class tax base in the District are based on business tax incentives. But if you are a middle- class taxpayer with school-age children you currently have to factor in approximately $10,000 a year in private education fees to feel comfortable with the level of education and safety you are providing to your family--$10,000 a year, per child, is a huge barrier for most middle-class families. The plans currently being considered in Congress that exclude discussion of schools may well create jobs. But jobs for whom? Even the promoters of those plans recognize that those jobs would primarily go to non-residents of the District. Projections show that two out of three jobs will go to non-residents. This will leave the District with more infrastructure demands and less money to deal with them--the exact status of the problems at present. As stated in the recent Brookings Institution study on D.C. entitled ``The Orphan Capital'' taxing metropolitan area residents where they live instead of where they work creates a revenue boon for Maryland and Virginia and a revenue disaster for the District. D.C. is the only city in a multi-State configuration in the country that has an income tax but is not able to tax its non-resident workers. This situation has also led D.C. to have the highest income tax rate on its residents in the area. That income tax rate is another barrier to the middle-class return to the city. The result is that $20 billion in wages leaves the District each year without being taxed, resulting in hundreds of millions of dollars flowing each year to the treasuries of Maryland and Virginia. Only 1 percent of this amount goes in the other direction--from D.C. residents working in the suburbs back in to D.C. This is a huge inequity that no other major city suffers. The history of the tax inequity began in 1973 when D.C. was given home rule. An astute Virginia representative convinced Congress to prohibit the non-resident tax from being enacted. A brilliant move, perhaps justified at the time, but it is unjust now, particularly to the children of D.C. It is not unexpected that the Maryland and Virginia Senators object violently when changing this situation is suggested. However, a win-win proposal for all D.C. metropolitan residents is possible. It will create high-paying job opportunities for high-school graduates through improved skill training. It will provide the needed repairs to the D.C. school infrastructure. It will provide funds to improve schools and other area training institutions. A recent report issued by the Greater Washington Board of Trade indicates that there are approximately 50,000 high-paying jobs requiring information technology skills in the Washington metropolitan area. These jobs pay on average $40,000 a year. By filling these jobs the Board of Trade estimates an additional $3.5 billion annually would be injected into the economy of what we call `the golden crescent'--the Washington metropolitan region that stretches from Annapolis, Maryland to Winchester, Virginia. But actually, this labor market shortage is a national problem. There are an estimated 190,000 information technology jobs going begging in the Nation for lack of skilled workers. Congress is presently trying to pass legislation to revamp our workforce training laws. We have at this time a prime opportunity to solve the D.C. metropolitan problem and provide a national model to help correct the serious national skill training deficiencies. I am introducing legislation today to accomplish this ``win-win'' structure. If the Washington metropolitan area were to become a model for the rest of the country we could jump start the rest of the country in solving this serious national problem. And this could be done with no additional Federal cost. But, of course, there is a hitch. My plan would require a 3-percent non-resident income tax on D.C. commuter wages. But remember, it would cost the commuters nothing because of laws requiring mutual offsetting tax credits. There would be an offset against the State income taxes of Maryland and Virginia. This would allow the commuter dollars to stay within the metropolitan region instead of going to Richmond and Annapolis with the hope of it coming back. One percent of this new revenue would be used to repair the D.C. school infrastructure. Bonds could then be amortized for the $2 billion needed. The other two percent would fund a trust overseen by metro-area school and business leaders to provide funding for regional skill training. Benefits to the regional economy should more than offset any losses to the States. It is hard to argue against growing the local Maryland and Virginia metro-area economies by $3.5 billion a year. This and future gains would more than offset the 1 percent going solely to D.C. And finally, this bill results in hundreds of millions of dollars in savings to the Federal Government; hundreds of millions of dollars of help to the suburbs surrounding the capital; the repair of the D.C. school system and the overall improvement of the regional school system; and potential revenue gains to Maryland and Virginia. Most importantly, it would make the congressional and administration plans sensible instead of senseless. We must not miss this opportunity.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I am introducing legislation today, pursuant to many recent discussions about the rescue plan for the District of Columbia, that reaffirms my strong belief that education must be the keystone of that plan and that fair and ready funding is available with no cost to the Federal Government. Every Washington area citizen should keep a careful watch on what Congress is doing to rescue the Capital from its present plight. The chorus resounds, ``we must get people to move back into the Capital! Its future depends on it!'' But if we examine the present congressional and administration plans and overlay them onto the root causes for the plight, serious questions arise as to their effectiveness. Studies indicate that the two leading causes, by far, that cause people to leave the District and keep them from living in the city are poor schools and high incidents of crime. Let's examine the plans that Congress has before it. Only the Senate plan as currently outlined even mentions education and that is basically a symbolic gesture to help repair the crumbling school infrastructure. The administration does consider the crime problem, but only at the end game of taking over the prison system. The administration's plan has no mention of repairing the failing D.C. educational system; a system which is among the worst in the Nation. The central administrative problem of the District's school system is not money, it is management chaos. But money is a serious concern in the area of school infrastructure, and D.C. has one of the worst school infrastructures in the Nation. In fairness to General Becton, the new chief executive officer for the schools, he is trying valiantly to upgrade overall standards but too much of his time is spent dealing with emergency school infrastructure repairs. Again this September, 43 schools will be threatened with closure at the outset of the academic year. Over $2 billion are needed just to fix building code violations. Crime in the District is directly related to the public school system. Some 40 percent of D.C. children drop out of school between grades 7 and 12. National studies show that about 80 percent of prison inmates are school drop-outs. A plan to help D.C. must have a strong component to improve education. As will be shown below, this need not carry a significant dollar cost to the Federal Treasury. In fact it will save millions. The President wants to be known as the Education President. Congress wants to be known as the Education Congress. Wouldn't the best demonstration of that intent be to start by improving the education system of the Nation's Capital? The present plans for enhancing a middle-class tax base in the District are based on business tax incentives. But if you are a middle- class taxpayer with school-age children you currently have to factor in approximately $10,000 a year in private education fees to feel comfortable with the level of education and safety you are providing to your family--$10,000 a year, per child, is a huge barrier for most middle-class families. The plans currently being considered in Congress that exclude discussion of schools may well create jobs. But jobs for whom? Even the promoters of those plans recognize that those jobs would primarily go to non-residents of the District. Projections show that two out of three jobs will go to non-residents. This will leave the District with more infrastructure demands and less money to deal with them--the exact status of the problems at present. As stated in the recent Brookings Institution study on D.C. entitled ``The Orphan Capital'' taxing metropolitan area residents where they live instead of where they work creates a revenue boon for Maryland and Virginia and a revenue disaster for the District. D.C. is the only city in a multi-State configuration in the country that has an income tax but is not able to tax its non-resident workers. This situation has also led D.C. to have the highest income tax rate on its residents in the area. That income tax rate is another barrier to the middle-class return to the city. The result is that $20 billion in wages leaves the District each year without being taxed, resulting in hundreds of millions of dollars flowing each year to the treasuries of Maryland and Virginia. Only 1 percent of this amount goes in the other direction--from D.C. residents working in the suburbs back in to D.C. This is a huge inequity that no other major city suffers. The history of the tax inequity began in 1973 when D.C. was given home rule. An astute Virginia representative convinced Congress to prohibit the non-resident tax from being enacted. A brilliant move, perhaps justified at the time, but it is unjust now, particularly to the children of D.C. It is not unexpected that the Maryland and Virginia Senators object violently when changing this situation is suggested. However, a win-win proposal for all D.C. metropolitan residents is possible. It will create high-paying job opportunities for high-school graduates through improved skill training. It will provide the needed repairs to the D.C. school infrastructure. It will provide funds to improve schools and other area training institutions. A recent report issued by the Greater Washington Board of Trade indicates that there are approximately 50,000 high-paying jobs requiring information technology skills in the Washington metropolitan area. These jobs pay on average $40,000 a year. By filling these jobs the Board of Trade estimates an additional $3.5 billion annually would be injected into the economy of what we call `the golden crescent'--the Washington metropolitan region that stretches from Annapolis, Maryland to Winchester, Virginia. But actually, this labor market shortage is a national problem. There are an estimated 190,000 information technology jobs going begging in the Nation for lack of skilled workers. Congress is presently trying to pass legislation to revamp our workforce training laws. We have at this time a prime opportunity to solve the D.C. metropolitan problem and provide a national model to help correct the serious national skill training deficiencies. I am introducing legislation today to accomplish this ``win-win'' structure. If the Washington metropolitan area were to become a model for the rest of the country we could jump start the rest of the country in solving this serious national problem. And this could be done with no additional Federal cost. But, of course, there is a hitch. My plan would require a 3-percent non-resident income tax on D.C. commuter wages. But remember, it would cost the commuters nothing because of laws requiring mutual offsetting tax credits. There would be an offset against the State income taxes of Maryland and Virginia. This would allow the commuter dollars to stay within the metropolitan region instead of going to Richmond and Annapolis with the hope of it coming back. One percent of this new revenue would be used to repair the D.C. school infrastructure. Bonds could then be amortized for the $2 billion needed. The other two percent would fund a trust overseen by metro-area school and business leaders to provide funding for regional skill training. Benefits to the regional economy should more than offset any losses to the States. It is hard to argue against growing the local Maryland and Virginia metro-area economies by $3.5 billion a year. This and future gains would more than offset the 1 percent going solely to D.C. And finally, this bill results in hundreds of millions of dollars in savings to the Federal Government; hundreds of millions of dollars of help to the suburbs surrounding the capital; the repair of the D.C. school system and the overall improvement of the regional school system; and potential revenue gains to Maryland and Virginia. Most importantly, it would make the congressional and administration plans sensible instead of senseless. We must not miss this opportunity.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I would like to engage in a brief colloquy with Senator Cochran regarding the status of legislation to modernize the Food and Drug Administration and reauthorize the Prescription Drug User Fee Act of 1992 [PDUFA]. The Labor Committee has reported out S. 830 with a strong bipartisan vote of 14-4. This legislation reauthorizes PDUFA for 5 years and brings the Agency's procedures up to date with the tremendous innovation now occurring in the health technology sector. It is my understanding that the bill before us does not reauthorize or extend the PDUFA program and appropriately leaves this action to the Labor Committee and the Congress. The bill before us does anticipate this reauthorization of PDUFA by setting a limit on the amount of fees which may be collected and expended once the reauthorization is enacted--which is a sensible approach. FDA reform and reauthorization of PDUFA go hand-in-hand and I am fully confident that we will have legislation accomplishing both at once on the floor in a timely fashion.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I rise today, on behalf of myself, Senator Murray, and Senator Snowe, to introduce the James P. Grant World Summit for Children Implementation Act of 1997. At the 1990 World Summit for Children, the United States and 158 other nations made a promise to the world's children. In signing the summit declaration and plan of action, they pledged, by the year 2000, to reduce child mortality rates by at least one-third, to reduce maternal deaths and child malnutrition by one-half, to provide all children access to basic education, and to provide all families access to clean water, safe sanitation and family planning information, and services. In the declaration they stated, ``We are prepared to make available the resources to meet these commitments.'' We have, in fact, made some progress over the last several years in meeting these admittedly ambitious objectives. Child mortality rates have fallen. Over 80 percent of the world's children are now immunized, saving 3 million lives annually. Nonetheless, millions of children are still dying every year for want of a vaccine costing just a few dollars or a Vitamin A capsule costing a few cents. It is estimated that 12 million children still die each year from preventable diseases and malnutrition. The objective of the legislation Senators Murray and Snowe and I are introducing today is to keep the United States focused on the commitments it made at the World Summit on Children. The bill would shift funds within the existing foreign assistance budget to meet the needs of children--without increasing overall foreign assistance. Specifically, it calls for increased allocations of funds for child survival, basic education, Vitamin A and other micronutrients, UNICEF, AIDS prevention and care, refugee assistance, family planning, and tuberculosis prevention and treatment. This is not just a foreign assistance bill. We can and must do more in our own country to improve the health and welfare of children at risk. Therefore, this legislation also calls for increased funding of domestic programs which touch the lives of children, namely Head Start and the Special Supplemental Food Program for Women, Infants, and Children, also known as WIC. Both of these programs have proven track records of improving the lives and prospects of children from low- income families. Mr. President, I appreciate that Congress is in the midst of serious fiscal belt tightening in order to meet our balanced budget objectives. This means that we must focus on our highest priorities. I would maintain, though, that we have no higher priority than our children and providing for their future. The programs cited in this bill, if properly funded, will improve the quality of life of children, here and abroad, and help them grow into healthy, productive adults. Moreover, it will do so without increasing our overall foreign assistance and with only a modest increase in the two domestic programs cited. Mr. President, this bill is good for children, good for their families, and good for our future. I urge my colleagues to support it.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I rise to introduce, with my colleagues Senators Kennedy, Frist, and Collins, the National Science Foundation Authorization Act of 1997. Our legislation authorizes the National Science Foundation [NSF] for fiscal years 1998 and 1999 and is similar to the legislation that was approved by the House of Representatives by voice vote on April 24, 1997. The strong bipartisan support which NSF enjoys is a product of its historic contribution to American security and competitiveness. The prominent role of science in the American war effort during World War II left Americans with a new appreciation of the importance of research in establishing and preserving economic and military security. Federally funded research provided the American war effort with radar, sonar, the proximity fuse, blood plasma, sulfanilamide, penicillin, and the atomic bomb. In 1944, President Roosevelt charged Vannevar Bush, his chief science adviser, with evaluating the most effective way to harness this technological infrastructure in peace-time. The Bush report--Science--The Endless Frontier--established a strategy and rationale for Federal support of basic research. The report argued that ``a nation which depends upon others for its new basic scientific knowledge will be slow in its industrial progress and weak in its competitive position in world trade regardless of its mechanical skill.'' This report provided the blueprint for creation of the National Science Foundation. NSF was established in 1950 to ``develop and encourage the pursuit of a national policy for the promotion of basic research and education in the sciences.'' Eight years later, following the 1957 Soviet launch of the Sputnik satellite, this mission was expanded to provide greater support for science education and literacy. Over the next three decades, NSF became the primary Federal sponsor of basic scientific research in mathematics, physical sciences, computer science, engineering, and environmental science at colleges and universities. Equally important to the future of our Nation, NSF has become a primary catalyst for math and science education reform. NSF's Role in Federal Research and Development The legislation which I am introducing with my colleagues authorizes $3.5 billion for the National Science Foundation in fiscal year 1998 and $3.6 billion in fiscal year 1999. Although the National Science Foundation's budget accounts for only 4 percent of Federal research and development funding, NSF provides 25 percent of Federal support to academic institutions for research. NSF's contribution is even greater in some disciplines--NSF provides nearly 50 percent of all Federal support for basic research in certain fields of science, including math, computer science, and environmental science. This funding supports approximately 19,000 research and education projects at more than 2,000 colleges, universities, primary, elementary, and secondary schools, businesses, and other research institutions. Competition for these grants is fierce. NSF funds only about one-third of the 30,000 proposals it reviews annually. The importance of this investment cannot be exaggerated. Over the past decade, private sector investment in research and development has eclipsed Federal investment in public science. However, the Federal investment in basic science plays a preeminent role in industrial innovation in the United States. A recent review of American industrial patent applications revealed that the Government or nonprofit foundations supported 75 percent of the main papers cited as the foundation for the new industrial innovation. The remaining 25 percent were funded by industry. NSF's Role in Science Education and Technology Literacy This bill authorizes $645 million for the education and human resources directorate [EHRD] in fiscal year 1998. EHRD has primary responsibility for NSF's education and training activities. In contrast with the programs of the Department of Education, NSF science and math education programs are experiments which link learning and discovery. Proposals are selected by outside peer review panels on the basis of their potential to provide long-lasting and broad impact. NSF has made notable contributions in the areas of curriculum and instructional material development, professional development, and improved the participation in science research and science education of women, minorities, and individuals with disabilities. This legislation strengthens and enhances these efforts. And finally, I would be remiss if I did not speak about the partnership which has been forged between the State of Vermont and the National Science Foundation. Last year, NSF grants were provided to the Barre Town Elementary School, Mountshire Museum of Science, Cabot School, Charlestown Elementary School, St. Michael's College, Johnson State College, and the University of Vermont. In 1992, the Vermont Institute for Science, Math, and Technology received a 5-year award of $7.9 million to establish a collaborative statewide education reform effort linking business, higher education, government, and community sectors. Our bill builds upon partnerships like that forged with the State of Vermont and offers a credible bipartisan response to the research and science education challenges facing our Nation. I urge the support of all my colleagues in the Senate for this worthwhile legislation.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I rise today, on behalf of myself, Senator Murray, and Senator Snowe, to introduce the James P. Grant World Summit for Children Implementation Act of 1997. At the 1990 World Summit for Children, the United States and 158 other nations made a promise to the world's children. In signing the summit declaration and plan of action, they pledged, by the year 2000, to reduce child mortality rates by at least one-third, to reduce maternal deaths and child malnutrition by one-half, to provide all children access to basic education, and to provide all families access to clean water, safe sanitation and family planning information, and services. In the declaration they stated, ``We are prepared to make available the resources to meet these commitments.'' We have, in fact, made some progress over the last several years in meeting these admittedly ambitious objectives. Child mortality rates have fallen. Over 80 percent of the world's children are now immunized, saving 3 million lives annually. Nonetheless, millions of children are still dying every year for want of a vaccine costing just a few dollars or a Vitamin A capsule costing a few cents. It is estimated that 12 million children still die each year from preventable diseases and malnutrition. The objective of the legislation Senators Murray and Snowe and I are introducing today is to keep the United States focused on the commitments it made at the World Summit on Children. The bill would shift funds within the existing foreign assistance budget to meet the needs of children--without increasing overall foreign assistance. Specifically, it calls for increased allocations of funds for child survival, basic education, Vitamin A and other micronutrients, UNICEF, AIDS prevention and care, refugee assistance, family planning, and tuberculosis prevention and treatment. This is not just a foreign assistance bill. We can and must do more in our own country to improve the health and welfare of children at risk. Therefore, this legislation also calls for increased funding of domestic programs which touch the lives of children, namely Head Start and the Special Supplemental Food Program for Women, Infants, and Children, also known as WIC. Both of these programs have proven track records of improving the lives and prospects of children from low- income families. Mr. President, I appreciate that Congress is in the midst of serious fiscal belt tightening in order to meet our balanced budget objectives. This means that we must focus on our highest priorities. I would maintain, though, that we have no higher priority than our children and providing for their future. The programs cited in this bill, if properly funded, will improve the quality of life of children, here and abroad, and help them grow into healthy, productive adults. Moreover, it will do so without increasing our overall foreign assistance and with only a modest increase in the two domestic programs cited. Mr. President, this bill is good for children, good for their families, and good for our future. I urge my colleagues to support it.

Mr. JEFFORDS. Mr. President, I rise to introduce, with my colleagues Senators Kennedy, Frist, and Collins, the National Science Foundation Authorization Act of 1997. Our legislation authorizes the National Science Foundation [NSF] for fiscal years 1998 and 1999 and is similar to the legislation that was approved by the House of Representatives by voice vote on April 24, 1997. The strong bipartisan support which NSF enjoys is a product of its historic contribution to American security and competitiveness. The prominent role of science in the American war effort during World War II left Americans with a new appreciation of the importance of research in establishing and preserving economic and military security. Federally funded research provided the American war effort with radar, sonar, the proximity fuse, blood plasma, sulfanilamide, penicillin, and the atomic bomb. In 1944, President Roosevelt charged Vannevar Bush, his chief science adviser, with evaluating the most effective way to harness this technological infrastructure in peace-time. The Bush report--Science--The Endless Frontier--established a strategy and rationale for Federal support of basic research. The report argued that ``a nation which depends upon others for its new basic scientific knowledge will be slow in its industrial progress and weak in its competitive position in world trade regardless of its mechanical skill.'' This report provided the blueprint for creation of the National Science Foundation. NSF was established in 1950 to ``develop and encourage the pursuit of a national policy for the promotion of basic research and education in the sciences.'' Eight years later, following the 1957 Soviet launch of the Sputnik satellite, this mission was expanded to provide greater support for science education and literacy. Over the next three decades, NSF became the primary Federal sponsor of basic scientific research in mathematics, physical sciences, computer science, engineering, and environmental science at colleges and universities. Equally important to the future of our Nation, NSF has become a primary catalyst for math and science education reform. NSF's Role in Federal Research and Development The legislation which I am introducing with my colleagues authorizes $3.5 billion for the National Science Foundation in fiscal year 1998 and $3.6 billion in fiscal year 1999. Although the National Science Foundation's budget accounts for only 4 percent of Federal research and development funding, NSF provides 25 percent of Federal support to academic institutions for research. NSF's contribution is even greater in some disciplines--NSF provides nearly 50 percent of all Federal support for basic research in certain fields of science, including math, computer science, and environmental science. This funding supports approximately 19,000 research and education projects at more than 2,000 colleges, universities, primary, elementary, and secondary schools, businesses, and other research institutions. Competition for these grants is fierce. NSF funds only about one-third of the 30,000 proposals it reviews annually. The importance of this investment cannot be exaggerated. Over the past decade, private sector investment in research and development has eclipsed Federal investment in public science. However, the Federal investment in basic science plays a preeminent role in industrial innovation in the United States. A recent review of American industrial patent applications revealed that the Government or nonprofit foundations supported 75 percent of the main papers cited as the foundation for the new industrial innovation. The remaining 25 percent were funded by industry. NSF's Role in Science Education and Technology Literacy This bill authorizes $645 million for the education and human resources directorate [EHRD] in fiscal year 1998. EHRD has primary responsibility for NSF's education and training activities. In contrast with the programs of the Department of Education, NSF science and math education programs are experiments which link learning and discovery. Proposals are selected by outside peer review panels on the basis of their potential to provide long-lasting and broad impact. NSF has made notable contributions in the areas of curriculum and instructional material development, professional development, and improved the participation in science research and science education of women, minorities, and individuals with disabilities. This legislation strengthens and enhances these efforts. And finally, I would be remiss if I did not speak about the partnership which has been forged between the State of Vermont and the National Science Foundation. Last year, NSF grants were provided to the Barre Town Elementary School, Mountshire Museum of Science, Cabot School, Charlestown Elementary School, St. Michael's College, Johnson State College, and the University of Vermont. In 1992, the Vermont Institute for Science, Math, and Technology received a 5-year award of $7.9 million to establish a collaborative statewide education reform effort linking business, higher education, government, and community sectors. Our bill builds upon partnerships like that forged with the State of Vermont and offers a credible bipartisan response to the research and science education challenges facing our Nation. I urge the support of all my colleagues in the Senate for this worthwhile legislation.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I would like to announce for information of the Senate and the public that an Executive Session of the Senate Committee on Labor and Human Resources will be held on Wednesday, July 23, 1997, 9:30 a.m., in SD-430 of the Senate Dirksen Building. The following are on the agenda to be considered: S. 1020, Arts and Humanities Amendments of 1997; the National Science Foundation Authorization of 1997; the Workforce Investment Partnership Act; and Presidential nominations. For further information, please call the committee, 202/224-5375. committee on labor and human resources

Mr. JEFFORDS. Mr. President, I would like to announce for information of the Senate and the public that a hearing of the Senate Committee on Labor and Human Resources Subcommittee on Public Health and Safety will be held on Thursday, July 24, 1997, 2:00 p.m., in SD-430 of the Senate Dirksen Building. The subject of the hearing is National Institutes of Health Reauthorization. For further information, please call the committee, 202/224-5375.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I rise today to pay tribute to an American and Austrian hero, Baron Georg von Trapp, on the 50th anniversary of his death. During his lifetime, Baron von Trapp stood for honor and courage. He held a deep devotion for both his country and his family. Baron von Trapp was remembered on the week-end of July 11, in a celebration at the Trapp Family Lodge in Stowe, VT. I regret that I was unable to attend, however I would like to take this opportunity to remember the significance of his life, made famous by the 1965 movie, ``The Sound of Music.'' It is a reflection of Baron von Trapp's spirit that he is not only an American legend, but he is also considered a hero in Austria, the homeland that he fled 60 years ago. It is a tribute to his excellence that the 89 members of the 1997 graduating class of the Theresianum Military Academy, the Austrian equivalent to West Point, voted Baron von Trapp their class hero, someone whom they all wished to emulate. Baron von Trapp was a celebrated military commander. He was honored with two medals for courage in battle, including the Maria Theresian Ritter Medal, Austria's highest, for sinking a French submarine in 1915. He was also influential in the development of submarine warfare and torpedoes. However, his love and devotion for his country never underscored the importance of his family. He made an intense connection with his children through music. Out of this connection came the famous Trapp Family Singers. When the Nazis invaded and were pressuring Baron von Trapp to join Hitler's ranks, he asked his family if they wanted to leave for America, saying that if anyone wanted to stay, they would all stay. Everyone wanted to leave. Although nothing could replace the love he had for his homeland, Baron von Trapp did grow to love his new home in Vermont. He found new passions in maple sugaring and farming. Because they spent most of the year touring, they rented out rooms in their lodge to skiers, starting what would eventually become a landmark in Vermont, the Trapp Family Lodge. Once again, I would like to express my admiration for Baron von Trapp and his entire family on the anniversary of his death.