Jack Reed

Mr. REED

Mr. REED. Will the Senator yield?

Mr. REED. Mr. President, I will yield myself such time as is controlled by the opponents of the amendment.

Mr. REED

Mr. REED. I thank the Senator from Massachusetts for yielding time. Very briefly, what we have done in the overall FDA law is create an incentive for companies, under section 510(k) to get approval of class I and II devices, to go out and pick out existing devices and say the new device is substantially equivalent. This, I think, provides pressure for companies to go out and simply say we are going to do exactly what these other devices do, even though their new design might have many more capabilities. This is not an academic problem. Take, for example, the issue of a biopsy needle. Typically these needles are very small. They remove a very small amount of tissue, about the size of a pencil tip. If the FDA was presented with a new biopsy needle that was claimed to be simply for biopsy of tissue but in fact removed 50 times that amount of tissue, a much, much larger bit of tissue, the suspicion would be that this is not just for biopsies, it's actually to remove the lesion. Yet under this law, today, as we speak, they could not look behind that claim on the label. They could not look behind it and say, give us some data about the removal of lesions. This is a serious public health problem. That is what we are addressing today. I hope, with Senator Kennedy's direction and leadership, we can resolve this along with Senator Jeffords and his colleagues. I yield the remainder of my time.

Mr. REED

Mr. REED. Mr. President, last November, the people of Rhode Island gave me the great honor of succeeding one of this Chamber's true giants: Senator Claiborne Pell. Throughout his years of service, Senator Pell committed himself to increasing access to education and, fittingly, his name has become synonymous with the fight to open the doors of higher education to all of our Nation's citizens, regardless of income. Senator Pell also dedicated himself to increasing access to the arts for all Americans, regardless of an individual's or a community's wealth. He recognized the power of the arts to inspire people of all ages, through national and local exhibitions as well as arts education. With his wise and steadfast leadership, Congress made a commitment to advancing these aims, creating a National Endowment for the Arts. I am proud to follow in Senator Pell's footsteps in supporting the NEA and a strong Federal commitment to the arts. Across the country and in my home State of Rhode Island, the arts enhance our culture and strengthen our economy. The events of recent years in Rhode Island's capital city of Providence are a testament to the power of the arts. The last half decade has seen the revitalization of Providence's downtown area. One major factor in this rebirth has been the emergence of Waterplace Park, which uses architecture to take advantage of the Woonasquatucket and Providence Rivers' natural beauty. This summer, with NEA support, the WaterFire exhibition was introduced to the park. In the few short months since its installation, this artistic display has already encouraged thousands of Rhode Islanders to rediscover Providence's treasures. The arts have also contributed to Providence's revival in other ways. Institutions like the recently renovated Providence Performance Arts Center and Trinity Repertory Company, both of which receive NEA support, provide our State's residents with opportunities to see well- renown and innovative theatrical works. In addition, the passage of new tax incentives for artists residing in downtown Providence has attracted a vibrant and increasingly active artistic community to the city. Taken together, these developments led USA Today to name Providence a ``Renaissance City'' in 1996. The Federal investment in the NEA is minimal. The $100 million this bill would provide for the NEA, for which I commend the chairman and ranking member of the subcommittee, represents less than 40 cents for each of our Nation's citizens. But with this tiny investment, the NEA does great things, offering our Nation's citizens increased access to all forms of the arts. In my State, the NEA supports not only theatrical productions, but also the work of the Children's Museum of Rhode Island, the youth concerts given by the Rhode Island Philharmonic Orchestra, and the interactive music program that Rhode Island Hospital offers to its patients. In my hometown of Cranston, the NEA supports the annual Labor and Ethnic Heritage Festival, which brings people of diverse backgrounds together to celebrate and learn about each others' traditions and cultures. These programs reach a wide range of Rhode Islanders, but even those who choose not to participate in these events benefit from NEA support and our State's vibrant arts communities. There is a close relationship between the arts in Rhode Island and economic growth. Working closely with the NEA, the Rhode Island State Council on the Arts supports many arts organizations, social service organizations conducting arts programs, and arts educators. One of the Rhode Island Council's funding categories, which supports 26 of the State's largest arts organizations, is known as general operating support. In 1995-96, the council's grants in this category totaled $355,000, with an average grant size of $10,000. For this investment of $355,000, the State of Rhode Island saw an enormous return. The 26 general operating support organizations directly contributed more than $24 million into the Rhode Island economy. More than 1.1 million people attended these organizations' programs last year, further spurring the economy. Using modest Department of Commerce multipliers, these figures suggest that the activities of the general operating support organizations alone contributed a total of more than $97 million to Rhode Island's economy last year. The figure for all arts organizations would be even greater. These impressive findings are repeated on a national scale. Recent studies have shown that the national nonprofit arts industry generates some $36.8 billion annually in economic activity; supports 1.3 million jobs; and produces $790 million in local government revenue and $1.2 billion in State revenue. For each dollar the NEA invests in communities, there is a twentyfold return in jobs, services, and contracts. Without question, this is a wise investment of our resources. We must also recognize the importance of national leadership in the arts, which only a strong, sufficiently funded National Endowment can provide. As my colleague from Utah, Mr. Bennett, noted yesterday, the NEA's seal of approval helps countless organizations across the country to raise matching funds from private sources to support the arts. In addition, by identifying arts education and increased access to the arts as its priorities, the NEA has promoted these issues nationwide. In recent years, we have seen a resurgence of our commitment to include the arts in elementary and secondary school curricula in Rhode Island, largely spurred by the NEA's emphasis on how exposure to the arts helps young people to grow more proficient in all subjects. I am proud to serve on the Labor and Human Resources Committee, which has examined many of these issues. I am also proud to be a cosponsor of S. 1020, which the committee passed earlier this year by a bipartisan 14-to-4 vote. S. 1020 reauthorizes and continues to reform the NEA, while maintaining a strong Federal commitment to the agency and its ideals. I look forward to the consideration of this important legislation on the Senate floor. Standing on this floor 32 years ago, Senator Pell observed that ``the arts throughout history have greatly enriched all truly worthwhile civilizations. The arts can put into tangible form the highest of man's creative ideas, so that they may become permanently memorable.'' Today, I wish to echo Senator Pell's wise counsel. I urge my colleagues to support the NEA at the funding level requested by the subcommittee and to preserve a strong Federal commitment to the arts. vanishing treasures

Mr. REED

Mr. REED. Mr. President, I ask unanimous consent to proceed as in morning business for the next 10 minutes.

Mr. REED. I thank the Chair. (The remarks of Mr. Reed pertaining to the introduction of S. 1169 are located in today's Record under ``Statements on Introduced Bills and Joint Resolutions.'') Mr. GORTON addressed the Chair.

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

Mr. REED

Mr. REED. Mr. President, we all recognize the need for qualified, well-trained and dedicated teachers to improve the education of students throughout the United States. Unfortunately, many students who are just returning from their summer vacations are entering classrooms where teachers have not been so prepared, who are not as qualified as they should be, and this, of course, impacts tremendously on the productivity and the excellence of American education. Today I am introducing legislation which I believe will change fundamentally the way teachers are trained and, thus, improve the quality of teaching in America's classrooms. This is absolutely critical, since over the next decade, 2 million new teachers will need to be hired. This is the result of a combination of retirements of existing teachers, together with the increase in student population which is taking place throughout the United States. Last year's report by the National Commission on Teaching and America's Future entitled, ``What Matters Most: Teaching for America's Future'', shed light on the disheartening state of the teaching profession in the United States: more than 12 percent of all newly hired teachers have no training whatsoever in educational technique and pedagogy; more than 14 percent enter the teaching profession without meeting State standards; 23 percent of all secondary teachers do not have even a minor in the main teaching field which they have been hired to perform, including more than 30 percent of mathematics teachers; and, in schools with the highest minority enrollments, students have less than a 50-percent chance of getting a science or mathematics teacher who holds a license and degree in the field which they are teaching. These findings were echoed also in ``Quality Counts: A Report Card on the Condition of Public Education in the 50 States,'' which was published this past January by Education Week. This report notes that on average, 4 out of 10 secondary teachers do not have a degree in the subjects they teach; there are too many unlicensed teachers in America's classrooms; and too few of our prospective teachers receive the high-quality education they need to be effective teachers. Overall, this report rated the States, and the average was C. No State received an A, and there were only eight B's: California, Colorado, Georgia, Kentucky, Massachusetts, Minnesota, Nebraska, and Vermont. Three States received D's for their teaching: Arizona, Hawaii, and Idaho. And the rest, including my State of Rhode Island, received a gentleman's C, which in today's competitive world is unsatisfactory for the future of our country and the success of our children. It must be noted that teacher quality varies tremendously; that in different classrooms in the same schools, you will see outstanding teachers in one and less qualified teachers in another. Many students are taught by a qualified teacher who understands their subject and how to teach students to excel. But not all students are so fortunate. These students are being deprived essentially of the quality education they need because their teacher is not well prepared and not qualified. ``What teachers know and do is the most important reflection on what students learn'' is the first premise of the National Commission on Teaching and America's Future. Given the statistics I just recited about the current state of teaching in America, it is no wonder American students are failing to make the grade in a very competitive world. Indeed, a study which compared high- and low-achieving elementary schools with similar student characteristics found that more than 90 percent of the variation in achievement in math and reading was directly attributable to differences in the qualifications of the teachers in those schools. It is also no wonder that American students don't fare well in international comparisons. The results of the eighth-grade Third International Mathematics and Science Study found that these students barely scored above the world average in science and below the world average in mathematics. And today, being mediocre is insufficient in order to face the challenges of a very complex world. Even though much has been done to address teacher quality, the truth is that the current system of teacher preparation does not give teachers a fair chance at success. Prospective teachers, those in training in our Nation's teacher colleges, are not likely to be provided with the panoply of experiences which they need, such as actual classroom time, structured practice opportunities, a talented and experienced teacher as a mentor, and the skills to work with diverse student populations. These are the tools they need to be adequately prepared and, sadly, many do not receive this help while they are in teacher preparation. Indeed, as the 1996 report by the National Commission on Teaching and America's Future notes, traditional teacher education programs are failing because they are too short, too fragmented and they use textbooks rather than active hands-on teaching methods. They also neglect to develop some of the ideas and concepts that are critical to success, such as working in teams and using technology. Sadly, I believe there is a real disconnect between the teacher colleges that prepare teachers and the elementary and secondary schools that hire them to teach the children of America. Consequently, beginning teachers are thrown into classrooms without the skills to succeed. As Linda Darling-Hammond, the Executive Director of the National Commission on Teaching and America's Future, writes, the message given to these teachers in the beginning of the school year is ``Figure it out yourself. We'll see you in June. . .if you make it that long!'' Due to this sink-or-swim method of teacher preparation, some teachers do not make it to June or survive past the first few years of teaching. As a USA Today article from earlier this year points out, 17 percent of new teachers leave the classroom after 1 year, and a 1987 study by Grissmer and Kirby estimated that 30 to 50 percent of new teachers leave the profession within 3 to 5 years. Add to this defection from the ranks of the profession the increased student enrollment due to the continuing Baby Boom Echo which will reach a record 52.2 million in 1997 and, indeed, increase each year through 2006, and impending retirements of many of our teachers. This situation creates a tremendous challenge and a need to prepare over 2 million new teachers to face the next century. The time is ripe to face this challenge. We must do so now before public support for education wanes. By enacting needed reforms and changes in how we prepare and continue the development of teachers, we can guarantee the success of both students and teachers. We must directly connect our teacher preparation and development system to our elementary and secondary schools. Our future teachers need and deserve the kind of hands-on training and ``real world'' experience they will get from more exposure and practice in today's classrooms, as well as the mentoring and assistance they will receive from our best and most experienced veteran teachers. My bill accomplishes this by fostering partnerships between the teacher colleges at our Nation's institutions of higher education and elementary and secondary schools. These partners should work in concert to prepare teachers adequately and keep their skills updated by working jointly to develop enhanced curricula and mentoring activities, as well as to research and implement sound teaching and learning practices. As Jerrald Shrive wrote in ``Lessons from Restructuring Experiences: Stories of Change in Professional Development Schools'': . . . educational partnerships and collaborations [between schools and universities] can be one significant piece of the actions necessary to move all of education to more productive levels. These premises underlie the legislation I introduce today. The Teacher Excellence in America Challenge Act or the TEACH Act, aims to improve the continuum of professional development from preservice preparation to the induction of new teachers to the improvement of veteran teachers, all of this designed to increase the achievement of our students. My legislation establishes a competitive 5-year grant program to provide grants to professional development partnerships consisting of institutions of higher education, public elementary and secondary schools, local educational agencies, and others, such as the State educational agency, teacher organizations, or nonprofit organizations. These partnerships must be based upon a mutual commitment to improve teaching and learning. These partnerships would use grant funding to support, as well as create, professional development schools, a reform that has been employed across this country and other industrialized nations and has shown success in increasing student achievement, better preparing prospective and beginning teachers, and providing critical ongoing opportunities for the professional development of veteran teachers. Professional development schools involve shared responsibility and cooperation between the institutions of higher education that prepare teachers and the public elementary and secondary schools that employ teachers, a system similar to teaching hospitals. An example of a professional development school can be found at the Sullivan School in Newport, RI. It is in a partnership with Salve Regina University. At the Sullivan School, Salve Regina students are given opportunities to practice teaching in a real classroom. Sullivan teachers are involved in observing these Salve Regina students, and they can also utilize the resources of Salve Regina University for professional development opportunities. Sullivan students go on field trips to Salve Regina for both higher education and career awareness activities, and the parents of these Sullivan students are also involved and are also provided opportunities for education and training. This is a model of one possible way to use professional development schools to enhance the preparation of teachers, the education of students, and the involvement of parents. Additional components of the TEACH Act include forging links between a university's school of education and their schools of arts and sciences. We have found in our discussions and research that many times within the university itself there is no collaboration, connection and concentration. This legislation will foster such cooperation. The TEACH Act also encourages the development of mentoring programs in which senior expert teachers would help younger teachers. It emphasizes technology training, which is a key piece now of higher education everywhere, and it recognizes that in order to be a good teacher, you have to have time to prepare to be a good teacher. It also would create a cadre of quality teachers that would act as a resource to enhance the professional development of all teachers and reestablishes principals as educational leaders. This is not a giveaway grant program. The TEACH Act offers resources to partnerships but it demands results. Strong evaluation provisions in the TEACH Act require that partnerships demonstrate increased student achievement, improved teacher preparation, increased opportunities for professional development, and also it insists that well-qualified teachers be placed in the classroom in order to continue to receive this grant funding. In addition, the legislation requires an independent national evaluation of the short-term and long-term impacts and outcomes of these professional development partnerships. Mr. President, given the growing need to update and improve the teacher training in this country, I expect we will see other proposals to address this problem offered in this body. I would be concerned if such proposals fell short on what we must accomplish by block granting training programs or failing to approach the kind of rigor that is included in the legislation I submit today. We have to have a rigorous and demanding legislative agenda in order to inspire and act as a catalyst for better teacher training across the country. Better teacher training will lead to better teachers. And better teachers will lead to better education and a better future for our children. My legislation puts us on track to answering the call of the National Commission on Teaching and America's Future to provide every student in America with access to competent, qualified, and dedicated teaching by the year 2006. I urge my colleagues to join me in this essential endeavor and to support the TEACH Act and help reform our system of teacher training as well as update the skills of teachers already in the classroom. Mr. President, I ask unanimous consent that a copy of this legislation be printed in the Record.

Mr. REED

Mr. REED. Mr. President, we all recognize the need for qualified, well-trained and dedicated teachers to improve the education of students throughout the United States. Unfortunately, many students who are just returning from their summer vacations are entering classrooms where teachers have not been so prepared, who are not as qualified as they should be, and this, of course, impacts tremendously on the productivity and the excellence of American education. Today I am introducing legislation which I believe will change fundamentally the way teachers are trained and, thus, improve the quality of teaching in America's classrooms. This is absolutely critical, since over the next decade, 2 million new teachers will need to be hired. This is the result of a combination of retirements of existing teachers, together with the increase in student population which is taking place throughout the United States. Last year's report by the National Commission on Teaching and America's Future entitled, ``What Matters Most: Teaching for America's Future'', shed light on the disheartening state of the teaching profession in the United States: more than 12 percent of all newly hired teachers have no training whatsoever in educational technique and pedagogy; more than 14 percent enter the teaching profession without meeting State standards; 23 percent of all secondary teachers do not have even a minor in the main teaching field which they have been hired to perform, including more than 30 percent of mathematics teachers; and, in schools with the highest minority enrollments, students have less than a 50-percent chance of getting a science or mathematics teacher who holds a license and degree in the field which they are teaching. These findings were echoed also in ``Quality Counts: A Report Card on the Condition of Public Education in the 50 States,'' which was published this past January by Education Week. This report notes that on average, 4 out of 10 secondary teachers do not have a degree in the subjects they teach; there are too many unlicensed teachers in America's classrooms; and too few of our prospective teachers receive the high-quality education they need to be effective teachers. Overall, this report rated the States, and the average was C. No State received an A, and there were only eight B's: California, Colorado, Georgia, Kentucky, Massachusetts, Minnesota, Nebraska, and Vermont. Three States received D's for their teaching: Arizona, Hawaii, and Idaho. And the rest, including my State of Rhode Island, received a gentleman's C, which in today's competitive world is unsatisfactory for the future of our country and the success of our children. It must be noted that teacher quality varies tremendously; that in different classrooms in the same schools, you will see outstanding teachers in one and less qualified teachers in another. Many students are taught by a qualified teacher who understands their subject and how to teach students to excel. But not all students are so fortunate. These students are being deprived essentially of the quality education they need because their teacher is not well prepared and not qualified. ``What teachers know and do is the most important reflection on what students learn'' is the first premise of the National Commission on Teaching and America's Future. Given the statistics I just recited about the current state of teaching in America, it is no wonder American students are failing to make the grade in a very competitive world. Indeed, a study which compared high- and low-achieving elementary schools with similar student characteristics found that more than 90 percent of the variation in achievement in math and reading was directly attributable to differences in the qualifications of the teachers in those schools. It is also no wonder that American students don't fare well in international comparisons. The results of the eighth-grade Third International Mathematics and Science Study found that these students barely scored above the world average in science and below the world average in mathematics. And today, being mediocre is insufficient in order to face the challenges of a very complex world. Even though much has been done to address teacher quality, the truth is that the current system of teacher preparation does not give teachers a fair chance at success. Prospective teachers, those in training in our Nation's teacher colleges, are not likely to be provided with the panoply of experiences which they need, such as actual classroom time, structured practice opportunities, a talented and experienced teacher as a mentor, and the skills to work with diverse student populations. These are the tools they need to be adequately prepared and, sadly, many do not receive this help while they are in teacher preparation. Indeed, as the 1996 report by the National Commission on Teaching and America's Future notes, traditional teacher education programs are failing because they are too short, too fragmented and they use textbooks rather than active hands-on teaching methods. They also neglect to develop some of the ideas and concepts that are critical to success, such as working in teams and using technology. Sadly, I believe there is a real disconnect between the teacher colleges that prepare teachers and the elementary and secondary schools that hire them to teach the children of America. Consequently, beginning teachers are thrown into classrooms without the skills to succeed. As Linda Darling-Hammond, the Executive Director of the National Commission on Teaching and America's Future, writes, the message given to these teachers in the beginning of the school year is ``Figure it out yourself. We'll see you in June. . .if you make it that long!'' Due to this sink-or-swim method of teacher preparation, some teachers do not make it to June or survive past the first few years of teaching. As a USA Today article from earlier this year points out, 17 percent of new teachers leave the classroom after 1 year, and a 1987 study by Grissmer and Kirby estimated that 30 to 50 percent of new teachers leave the profession within 3 to 5 years. Add to this defection from the ranks of the profession the increased student enrollment due to the continuing Baby Boom Echo which will reach a record 52.2 million in 1997 and, indeed, increase each year through 2006, and impending retirements of many of our teachers. This situation creates a tremendous challenge and a need to prepare over 2 million new teachers to face the next century. The time is ripe to face this challenge. We must do so now before public support for education wanes. By enacting needed reforms and changes in how we prepare and continue the development of teachers, we can guarantee the success of both students and teachers. We must directly connect our teacher preparation and development system to our elementary and secondary schools. Our future teachers need and deserve the kind of hands-on training and ``real world'' experience they will get from more exposure and practice in today's classrooms, as well as the mentoring and assistance they will receive from our best and most experienced veteran teachers. My bill accomplishes this by fostering partnerships between the teacher colleges at our Nation's institutions of higher education and elementary and secondary schools. These partners should work in concert to prepare teachers adequately and keep their skills updated by working jointly to develop enhanced curricula and mentoring activities, as well as to research and implement sound teaching and learning practices. As Jerrald Shrive wrote in ``Lessons from Restructuring Experiences: Stories of Change in Professional Development Schools'': . . . educational partnerships and collaborations [between schools and universities] can be one significant piece of the actions necessary to move all of education to more productive levels. These premises underlie the legislation I introduce today. The Teacher Excellence in America Challenge Act or the TEACH Act, aims to improve the continuum of professional development from preservice preparation to the induction of new teachers to the improvement of veteran teachers, all of this designed to increase the achievement of our students. My legislation establishes a competitive 5-year grant program to provide grants to professional development partnerships consisting of institutions of higher education, public elementary and secondary schools, local educational agencies, and others, such as the State educational agency, teacher organizations, or nonprofit organizations. These partnerships must be based upon a mutual commitment to improve teaching and learning. These partnerships would use grant funding to support, as well as create, professional development schools, a reform that has been employed across this country and other industrialized nations and has shown success in increasing student achievement, better preparing prospective and beginning teachers, and providing critical ongoing opportunities for the professional development of veteran teachers. Professional development schools involve shared responsibility and cooperation between the institutions of higher education that prepare teachers and the public elementary and secondary schools that employ teachers, a system similar to teaching hospitals. An example of a professional development school can be found at the Sullivan School in Newport, RI. It is in a partnership with Salve Regina University. At the Sullivan School, Salve Regina students are given opportunities to practice teaching in a real classroom. Sullivan teachers are involved in observing these Salve Regina students, and they can also utilize the resources of Salve Regina University for professional development opportunities. Sullivan students go on field trips to Salve Regina for both higher education and career awareness activities, and the parents of these Sullivan students are also involved and are also provided opportunities for education and training. This is a model of one possible way to use professional development schools to enhance the preparation of teachers, the education of students, and the involvement of parents. Additional components of the TEACH Act include forging links between a university's school of education and their schools of arts and sciences. We have found in our discussions and research that many times within the university itself there is no collaboration, connection and concentration. This legislation will foster such cooperation. The TEACH Act also encourages the development of mentoring programs in which senior expert teachers would help younger teachers. It emphasizes technology training, which is a key piece now of higher education everywhere, and it recognizes that in order to be a good teacher, you have to have time to prepare to be a good teacher. It also would create a cadre of quality teachers that would act as a resource to enhance the professional development of all teachers and reestablishes principals as educational leaders. This is not a giveaway grant program. The TEACH Act offers resources to partnerships but it demands results. Strong evaluation provisions in the TEACH Act require that partnerships demonstrate increased student achievement, improved teacher preparation, increased opportunities for professional development, and also it insists that well-qualified teachers be placed in the classroom in order to continue to receive this grant funding. In addition, the legislation requires an independent national evaluation of the short-term and long-term impacts and outcomes of these professional development partnerships. Mr. President, given the growing need to update and improve the teacher training in this country, I expect we will see other proposals to address this problem offered in this body. I would be concerned if such proposals fell short on what we must accomplish by block granting training programs or failing to approach the kind of rigor that is included in the legislation I submit today. We have to have a rigorous and demanding legislative agenda in order to inspire and act as a catalyst for better teacher training across the country. Better teacher training will lead to better teachers. And better teachers will lead to better education and a better future for our children. My legislation puts us on track to answering the call of the National Commission on Teaching and America's Future to provide every student in America with access to competent, qualified, and dedicated teaching by the year 2006. I urge my colleagues to join me in this essential endeavor and to support the TEACH Act and help reform our system of teacher training as well as update the skills of teachers already in the classroom. Mr. President, I ask unanimous consent that a copy of this legislation be printed in the Record.

Mr. REED

Mr. REED. I yield the floor. Amendment No. 1097 (Purpose: To enhance food safety for children through preventive research and medical treatment)

Mr. REED. I ask for the yeas and nays.

Mr. REED. Thank you, Mr. President. I ask unanimous consent to lay aside the pending amendment.

Mr. REED. Mr. President, I send an amendment to the desk and ask for its immediate consideration.

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

Mr. REED. Thank you, Mr. President. Prior to offering an amendment, I ask unanimous consent to yield the floor to my colleague, the Senator from Louisiana, and have the opportunity to reclaim the floor and present my amendment, if I may.

Mr. REED. Mr. President, I rise this afternoon to offer an amendment with my Republican colleague from Maine on the Labor and Human Resources Committee, Senator Susan Collins, and we are joined by a host of other colleagues--Senator Kennedy, Senator Chafee, Senator Smith of Oregon, Senator Harkin, Senator Dodd, Senator Conrad, Senator Levin, Senator Kohl, Senator Wyden, Senator Lautenberg, Senator Murray, Senator Wellstone, Senator Bingaman, Senator Reid of Nevada, Senator Feingold, Senator Dorgan, Senator Torricelli, Senator Kerrey, Senator Johnson, and Senator Landrieu. I believe this indicates the widespread depth of concern and support for maintenance of the State Student Incentive Grant Program, or SSIG, as it is known. This is a remarkable program, which requires State governments to match Federal resources on a dollar-for-dollar basis and provides direct higher education grant assistance to needy students. I had originally intended to offer, along with my colleague Senator Collins, an amendment which would have restored SSIG funding to last year's level of $50 million, but out of deference to the subcommittee chairman and also because of a lack of sufficient offset, the amendment today adds back $35 million for SSIG with an offset of unobligated balances from prior years. In accepting this change, it is our intent to work with Chairman Specter and Senator Harkin, as they have agreed, to ensure that funding for SSIG, at no less than $35 million and hopefully even more, is secured during conference deliberations with the other body. Mr. President, I want to tell all of my colleagues why this amendment and saving student aid funding is so vitally important. SSIG is critical to higher education, critical to the dreams of more than 700,000 students across the Nation and 13,000 students just in my home State of Rhode Island alone. We are all familiar with another higher education grant, the Pell grant, and, as I think many in this Chamber, as well as students, parents, and those involved in higher education know, the purchasing power of the Pell grant has fallen drastically in comparison to inflation and the skyrocketing cost of college education. Students have searched for other sources of need-based higher education grants and have come to rely upon SSIG, the State Student Incentive Grant. With a relatively modest amount of Federal funding, this essential program encourages States to provide need-based financial aid to students in the form of grants and community service work study awards. SSIG grants are targeted to the neediest undergraduate and graduate students. The average family income for SSIG recipients in 1991-92 was approximately $12,000, which is below the Federal poverty level for a family of four. The average SSIG-supported grant was about $1,200 in 1995-96. This program reaches those families who are most desperately in need of support to send their children to college. Moreover, this program is extremely efficient. Every SSIG dollar goes to the students. These funds are not used in any way to cover administrative costs. With an SSIG expenditure at the Federal level of $63 million in fiscal year 1996, the program leveraged more than $784 million in State matching funds and served more than 700,000 students across America. In Rhode Island, an SSIG Federal expenditure of roughly $334,000 leveraged over $8 million in Rhode Island expenditures, serving more than 13,000 students. The history of this program is simple. Before its enactment 25 years ago, only 26 States provided need-based assistance to students. Now, all 50 States provide such assistance. While SSIG has been successful in increasing State aid, it is not true that it has outlived its usefulness. The statutory purpose of SSIG is not simply to start up State programs. Instead, its purpose is to encourage and assist States in making need-based grant and community service work-study awards to students. Indeed, if SSIG is eliminated, nine States, including Alabama, Arizona, Georgia, and Mississippi, could lose their entire grant program. In these States, SSIG funds represent 25 percent or more of their entire student grant program. It is unlikely they would sustain these programs without this Federal assistance and encouragement. In addition, if SSIG were eliminated, 43 States have already said they would reduce the number and amount of need-based grants, according to the National Association of State Student Grant and Aid Programs. Thirteen States could face a 40-percent drop in funding for need-based grants, according to PIRG's Higher Education Project. Even with Federal funding, my home State of Rhode Island failed to maintain funding for the State grant program in 1993 and lost Federal SSIG funding. So Rhode Island, a State known for its commitment to education, also faces serious harm to its need-based program. How could SSIG have outlived its usefulness if States have already or are threatening to shut down student grant programs and cut student aid? Even the Appropriations Committee has noted that there is wisdom in maintaining funding for this program. In this Congress, the Senate will work on the reauthorization of the Higher Education Act, which covers most higher education grants and loan programs including Pell grants and SSIG. During this reauthorization process, the Senate Labor and Human Resources Committee, on which I serve, along with Senator Collins, will comprehensively review all higher education aid programs. Prior to the Labor Committee's work, I believe it would be inappropriate and unfair for Congress to eliminate a successful program like SSIG. It is a program that deserves support, but also deserves review, which it will receive in the reauthorization of the Higher Education Act. It is also interesting to note that at a time when the majority party in this Congress is calling for more Federal money to be returned to the States, eliminating SSIG would end a successful program that gives States substantial flexibility and resources to help them help their citizens on to a better life. In addition, it is important to note in the recent budget, we have gone a long way in providing tax incentives to send young people to college, tax credits and deductions from taxes, but the people that are served by SSIG are those that cannot readily use the tax system to help their children go to college. In this way, SSIG is vitally important because it is a grant program directly to those low-income Americans that need a chance to share in the same opportunity that we have, in our wisdom, provided through the tax system to upper-income and middle- income Americans. Now, let me emphasize that SSIG is more important than ever as college costs continue to grow faster than income and grant aid, and as the grant-loan imbalance widens. In 1975, 80 percent of student aid came in the form of grants and 20 percent in the form of loans. Now, the opposite is true. Let me also add that low-income students are finding it particularly hard to afford higher education. Less than 50 percent of high school graduates with family incomes under $22,000 go on to college, while more than 80 percent of their higher income counterparts go on to pursue education beyond high school. Frankly, if we do not reverse this trend, if we do not let every segment of our society go on to higher education, we will continue to develop a bifurcation of our society and our economy as young people with a chance to go on to college gain skills that make them employable and, indeed, enhances their incomes and ability to seize all the opportunity in our society, while others are left out. We cannot let that happen. SSIG continues to make a difference for needy students in many States. However, I again remind my colleagues that nine States would likely end their grant programs without Federal encouragement and funding. Moreover, 43 States have said they would cut grants if SSIG were eliminated. Mr. President, we should be helping all our citizens achieve the American dream by ensuring access to higher education, especially for hard-working families whose wages have not kept up with inflation. Our amendment seeks to provide $35 million for SSIG. It is not a lot of money in a bill that contains more than $269 billion in funding, but it will make a huge difference to the students who rely upon it. This amendment, I understand, is agreeable to the chairman and the ranking member and they have committed to work with Senator Collins and myself to fight for this funding in conference. I have a letter from the American Council of Education in support of the amendment, and I ask unanimous consent that it be printed in the Record.

Mr. REED. I urge my colleagues to support this amendment. We cannot afford to pass up this opportunity to aid students who in turn will build a stronger and more prosperous America.

Mr. REED. Will the Senator yield?

Mr. REED. Would the Senator also include in this request a modification that precludes any second-degree amendments on my amendment?

Mr. REED. I understand this vote is scheduled for 5 o'clock.

Mr. REED

Mr. REED. Thank you, Mr. President. I thank the Senator from Massachusetts for yielding. Mr. President, over the past several months, we on the Labor Committee have been working diligently and effectively to try to create a Food and Drug Administration reform bill--a bill that truly balances the need for technological innovations and flexibility but that doesn't upset the fundamental obligations of the Food and Drug Administration to protect the public's health and safety. And we have made progress. We have to recognize that the purpose of this bill fundamentally is the reauthorization of the Prescription Drug User Fee Act. That is the critical dimension that we are faced with. With the expiration of that authority at the end of this month or the beginning of the next fiscal year, we would lose a very valuable program, a program that has generally provided great success in speeding up approval, of ensuring that drugs are brought to the marketplace in a much more efficient and effective way. Linking the authorization of the Prescription Drug User Fee Act to the controversial FDA reform proposals may threaten many of the benefits of PDUFA--the acronym for the Prescription Drug User Fee Act. I hope that will not be the case. I hope we can work out some of these details and reach a suitable conclusion. Much of the credit is due to the leadership of both Senator Jeffords and Senator Kennedy. They have been working diligently to arrive at a legislative proposal that would balance the need for a rapid and effective regulatory response to the approval of medical drugs and devices but also fundamentally protect the public health. Frankly, I suggest that this is the motivation for our debate today. The critical issue has to be, must be, and should be the protection of the public health and safety. That is why we have a Food and Drug Administration. That is why we maintain a strong, vigilant Food and Drug Administration. We have agreement, I believe, that PDUFA is working, and that we can move forward with PDUFA. The industry is, indeed, thrilled by it. It works well. They pay fees dedicated to the examination and review of proposed drugs and devices. These resources have enabled the FDA to speed up the process. In terms of the FDA process, PDUFA has done a great deal. The bill that we are considering on the floor today includes a reauthorization of PDUFA, and represents many improvements in the original bill that we started with, and, indeed, even the bill that emerged from the committee. But there are still critical issues that have to be addressed in terms of protection of the public health and safety. They are complicated issues. They are issues that require careful review and deliberation. One of the disappointing aspects of this process is that the final version of this bill was just released publicly Wednesday, the same time the cloture motion was filed. Again, in the spirit of careful, thorough, thoughtful review, this does not provide the best opportunity to review all the nuances of this legislation. So that is why I believe the effort today, led by Senator Kennedy, is a very important one. It allows this body to more carefully, more intelligently and more thoroughly review provisions that will affect the lives of untold Americans. I daresay that the Food and Drug Administration reaches the lives of every American, probably more so than any regulatory agency in this country. All the prescription drugs on the shelves, all of the medical devices that are used--all of them, the food additives, all of these things-- are influenced by FDA action. We have to be very careful, very thoughtful and, I believe, methodical. So today's debate--and again I commend Senator Kennedy for ensuring that we do have a thorough debate--is vitally important to that goal. I mentioned that we have made progress on this bill, but I should say there are also areas that need improvement--desperately need improvement. There is one in particular I would like to speak to for a moment, and that is the issue of medical device labeling. This bill contains a medical device provision which potentially opens up a serious public health loophole. Section 404 of this bill would prevent the Food and Drug Administration, before clearing a device for the market, from examining whether a device will be used for an unlabeled use before clearing it for use in the market. This provision could allow the gaming of the FDA process where companies could attempt to escape a requirement of providing essential safety and effectiveness data by adopting a very narrow use for the device. For example, under this bill, a company could get approval for a biopsy needle from the FDA, even though it may be used in practice-- and, indeed, this would be something that the company might have knowledge of--for an entirely different purpose, such as for tumor removal. Yet, the company could avoid submitting to the FDA any safety or effectiveness data on this device for tumor removal because FDA would be prohibited by law from asking for that data. In other words, the FDA would be prohibited from looking behind the limited proposed use of the device. Another example is a company which receives approval of a general surgical laser, even though the laser is clearly designed for prostate surgery. The public health of the American people is dependent upon a thorough and complete review of such devices, and yet, section 404 would essentially put blindfolds on the agency. They very well might know from general literature, the company might very well know from its sales force who, when they present this product, hear medical professionals saying, ``This is great, but I'll use it for something else,'' and yet the FDA would not be able to require data on this likely use. This provision would prevent the FDA from providing for the safety and effectiveness of medical devices. The issue of allowing FDA to look beyond the conditions of use on the label and evaluating the use of a device is somewhat of a gray area. Certainly, advances in technology, new uses by the medical profession of devices should not be inhibited, but we also do not want to compromise the ability of the FDA to protect the public health. That is the great balance we must strike in this legislation: allowing for technological flexibility, regulatory efficiency, but not compromising the public health of the American people. It is a balance that we are edging close to. We have made progress since the adoption of this bill at the committee level, but more progress can and should be made. We are committed to making such progress. We are committed, I think, to coming up with final legislation that will reflect both the need for technological efficiency and innovation, but also protecting the public health of the American people. I hope we can do that. I know that we desperately want, all of us, to reauthorize PDUFA so that we can continue that outstanding record of regulatory efficiency and approvals that have been generated by PDUFA. But, I don't think any of us want to create a situation where months from now or years from now we are confronted with public health problems because we acted hastily or we acted without the thoughtful, careful review that is necessary to develop legislation that protects the public health and provides for all of the new innovations that are fast becoming part of our medical marketplace. Again, I commend Senator Kennedy for his unflinching efforts to ensure that these concerns are fully addressed. I also thank and commend the chairman of the committee who has worked diligently, sincerely and doggedly over these last several months to try to bring together opposing views on the committee. I believe we are close but not quite there yet. I believe in the days ahead, we can, in fact, reach a position of which we will all be very, very proud. At this time, I am prepared to yield back to the senior Senator from Massachusetts.

Mr. REED. If the Senator will yield for response, one of my fears is that not only would this situation result in perhaps not giving the FDA data on uses that the companies are aware of in the marketplace, but it might provide a subtle incentive in marketing these devices to encourage uses that are not authorized by the FDA and certainly not to be attentive to those types of uses and report back to regulatory authorities. Again, when we think about this legislation, we have to think about also that there are a complex set of incentives and disincentives for the best possible behavior by pharmaceutical and device companies. I don't think any of us would like to unwittingly create a situation in which devices approved for one use are cavalierly marketed by companies for other uses and are merely winked at when they do not fall within the category of the approval. So that is another important issue. There is another aspect of this which I would like to raise with Senator Kennedy, and that is, I understand that Secretary Shalala has communicated concerns about this issue. I understand that she is concerned about this and her concern may be of such a level that it could suggest that she recommend to the President a veto of this legislation. A veto would be, I think, particularly unfortunate since we have worked so hard, we have made so much progress, and we have reached a point where we are very close to legislation which could virtually pass with unanimity in this body. It would be unfortunate that this type of provision of the bill would disrupt that process. I wonder if that is correct.

Mr. REED. If the Senator will yield again, I concur with his analysis, with the danger, and also with the fact this has risen to the level of the Secretary of Health and Human Services as a significant an obstacle to passage or acceptance by the President. Again, I don't think any of us are suggesting that pharmaceutical and device manufacturers are going to--some may, but I hope not--deliberately try to bait and switch. But the market is evolving so much and there is so much innovation that if the FDA can't, by reviewing the literature, make an estimate of what a device might be used for and ask for data on that likely use, then I think we are really constraining FDA--as I said before, putting blinders on the FDA. That, I think, would be a mistake in policy. And I also feel, based upon my sense of the progress we have made to date, that this is not an unsolvable issue. This issue is one that there is compromise language, with which we can both provide for innovation, we can provide for marketing, we can avoid cumbersome demands by the FDA. But we can still give the FDA the authority to say, ``Listen, you are marketing this device for a very specific use, but we are aware that it would likely be used two or three others ways. How does this device work in those contexts?'' This is a very serious issue. Once again, without the efforts of the Senator from Massachusetts to try to focus on these issues, it well could have been lost in the clamor of getting out of here and getting on with other business. It would be, in the long run, unfortunate for the public health of the American people. Let me conclude by saying that it is vitally important in ensuring when the bill passes--and I believe we all hope it passes--it passes in a way we will all be proud of and will deal with all these issues that, leaving no unintended loophole or unintended consequences. I hope that we will have thought it through, worked it out and come up with legislation that will provide for the kind of technological innovation we all want, provide for the kind of efficient regulatory review that we all want and certainly protect the safety of the American public which not only we want but the American people demand. I yield the floor.

Mr. REED. If I may, if the Senator will yield, I, too, concur with the support, the assistance, the advice, and I think the general goodwill that the industry has brought to this debate. We are now, though, at the detail level, the fine detail, technical detail, and that is critically important. These are the types of details which later on come back to haunt us sometimes if they are not done well.

Mr. REED. The industry has been responsive and reasonable, and we want to incorporate their best advice but also recognize that our ultimate responsibility is to the health of the American people. Something else, too, that the Senator alluded to was that this industry is becoming a very important part of our economy, not just nationally but locally. In Rhode Island we have several companies that are emerging as leaders in the industry. They offer not only extraordinary opportunities to help the American people, indeed, the people of the world, through medicine and devices, but also are becoming increasingly important economic powers within our communities--sources of jobs, employment and the types of activity that we certainly want to encourage. Part of our motivation today is to ensure that we do this right. We need to give them the kind of direction and incentives that will make them stronger competitors in the international marketplace, stronger sources of strength in the communities of America, but also make them responsible and accountable to the American people through appropriate regulation. All of these things we can accomplish because I believe that the differences that separate us at the moment are not fundamental, ideological or in any other sense broad based. They are, rather, important details which will ensure or not ensure that this legislation can be used effectively to protect the public health. So again I thank the Senator.