[Congressional Record (Bound Edition), Volume 151 (2005), Part 3]
[Senate]
[Pages 2973-2987]
[From the U.S. Government Publishing Office, www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. AKAKA (for himself, Mr. Sarbanes, and Mr. Corzine):
  S. 468. A bill to amend the Higher Education Act of 1965 to enhance 
the literacy in finance and economics, and for other purposes; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. AKAKA. Mr. President, I rise to reintroduce comprehensive 
legislation aimed at addressing the issue of economic and financial 
illiteracy on college campuses. I am referring to the worrisome 
problems of skyrocketing debt levels, low rates of saving, and the 
proliferation of unchecked predatory practices by unscrupulous 
financial institutions among young adults who hold our country's future 
in their hands. Entitled the College LIFE or College Literacy In 
Finance and Economics Act, this bill has the support of Senators 
Sarbanes and Corzine. I thank my colleagues from Maryland and New 
Jersey for joining me as original cosponsors of this measure. I also 
thank Senator Enzi, the Chairman of the Health, Education, Labor, and 
Pensions Committee, for working with me on financial literacy as it 
affects all constituencies, including college students.
  The problem we are working to address with the College LIFE Act is 
simple. Our college students are many of America's best and the 
brightest and will go on to become leaders--in business, education, 
politics, the military, the community--any area you can name. I find it 
wonderful that many young people are fulfilling their dreams of higher 
education in numbers that I did not imagine when I was in college. In 
fact, as reported by the Census Bureau, college enrollment was 
estimated at 15.9 million for the current school year, compared to 5.7 
million in 1965 when the Higher Education Act was enacted. However, I 
am gravely concerned, both as a member of this body and particularly as 
a grandparent and great-grandparent, that our young people are entering 
college without proper direction or good skills for money management or 
economic decisionmaking.
  As we work on increasing access to higher education, we must give 
students access to tools needed to make sound economic and financial 
decisions once they are on campus; however, the lack of personal 
finance and economics standards or implementation of existing standards 
in elementary and secondary education in a number of States results in 
many students arriving at college with little understanding of economic 
concepts like supply and demand or benefits versus costs, or personal 
finance concepts such as household money management or the importance 
of maintaining good credit history. Without this basic understanding, 
college students are not effectively evaluating credit alternatives, 
managing their debt, and preparing for long-term financial goals, such 
as saving for a home or retirement.
  Imagine life from the point of view of a college student. A young 
adult leaves his home and travels many miles--thousands of miles in the 
case of Hawaii students attending mainland colleges--to the campus that 
holds his hopes and dreams. Perhaps he is not being mindful of how much 
money he needs for textbooks, school supplies, or student fees. He 
visits the campus bookstore and walks out with a bag that includes a 
preapproved credit card application, which he immediately completes and 
sends. Months later, he has joined other credit card-holding college 
students who, on average, have credit card balances above $3,000. 
Sophomore year rolls around and, instead of conferring with his parents 
about the details of his renewal FAFSA for student financial aid or 
master promissory note, he is saddled with another $20,000 loan. 
According to the Census Bureau, average college tuition, room, and 
board have increased to $29,119 for a four-year private institution and 
to $9,953 for a four-year public institution. The same scenario repeats 
itself in junior and senior year. Finally, after completing all 
coursework, he graduates, finds an entry-level job, and realizes that, 
after servicing his debt, he has little left to spend on basics such as 
food, transportation, and rent, much less career clothing or a new 
briefcase. His lack of knowledge about how to properly use credit has 
led him to anxiety-causing financial missteps. With appropriate 
financial and economic literacy, he may have known what debt load to 
anticipate and made wiser financing and spending decisions while in 
school.
  Instead, she may be on the road to true financial trouble. A U.S. 
Public Interest Research Group and Consumer Federation of America 
analysis of Federal Reserve data indicates that the average household 
with debt carries approximately $10,000 to $12,000 in total revolving 
debt and has nine credit cards. From January through September of 2004, 
approximately 1.2 million consumers filed for bankruptcy, keeping pace 
with last year's record level, which is almost half of the number of 
college diplomas expected to be conferred this year at 2.5 million. 
Furthermore, the Federal Reserve Board reports that Americans currently 
pay more than 13 percent of after-tax income to service their debts. We 
must ensure that our youth make the right decisions to follow a better 
financial path. This is especially in light of a report cited by Dan 
Iannicola, Jr., Deputy Assistant Secretary of the Treasury for 
Financial Education, at a House hearing last Congress, noting that 
youths spent more than $172 billion in a recent year, and figures from 
MarketResearch.com noting that typical 8- to 14-year-olds spend--from 
allowances, jobs, and gifts--nearly $1,300 a year or $25 a week.
  The College LIFE Act represents a comprehensive approach to assist 
upcoming generations of Americans. It proposes four new grant programs 
that provide resources to encourage experimentation with delivery 
systems--innovative methods used in or out of the classroom to increase 
college students' financial literacy. Another grant would allow higher 
education institutions to share best practices about or create personal 
finance courses where none exist. A third grant would assist efforts 
that are looking at the best ways to integrate personal finance and 
economic education into basic educational subjects, which is especially 
important as schools are facing challenges under the No Child Left 
Behind Act and are tempted to focus on subjects being tested for 
Adequate Yearly Progress. The final grant would train teachers and high 
school counselors toward increasing financial and economic literacy in 
grades K-12 so that our college students are prepared when they arrive 
at college campuses.
  The bill also proposes a pilot program for five higher education 
institutions to encourage students to take a personal finance course 
and participate in preventive annual credit counseling, working in 
conjunction with State or local public, private, and nonprofit entities 
selected by the local education agency or the school, and measuring the 
effectiveness of efforts in any behavioral changes that may result. It 
promotes greater collaboration with and support from Federal agencies 
in the form of the Financial Literacy and Education Commission. 
Finally, the measure emphasizes the importance of personal finance and 
economic education and counseling by authorizing these activities as 
allowable uses in existing Higher Education Act programs, such as TRIO, 
GEAR UP, and Title III and Title V Serving Institutions.
  Furthermore, I intend the reach of this bill to be beyond the 
traditional college student. Our returning college students are a vital 
part of society--many who are already community leaders and 
breadwinners for their families who have already gained valuable work 
experience that they may use as they learn a new field or continue 
their undergraduate study in the pursuit of a graduate or doctoral 
degree. In addition, older adults who are entering higher education for 
the first time can also be lauded for their enterprising spirit in 
wanting to better their lives by earning an associates or bachelors 
degree. I anticipate that the assistance provided through the College 
LIFE Act will work to provided needed help to many of these students as 
well.
  I am looking forward to continuing to work with my colleagues to have 
the

[[Page 2974]]

College LIFE Act passed or included in the upcoming Higher Education 
Act reauthorization. I encourage my colleagues' support for this bill.
                                 ______
                                 
      By Mr. ROCKEFELLER (for himself, Mr. Lott, Mr. Roberts, Ms. 
        Snowe, Mr. Bayh, Mr. Chambliss, Ms. Mikulski, Mr. Corzine, Mr. 
        Levin, Mr. DeWine, Mr. Wyden, Mr. Bond, Mrs. Feinstein, Mr. 
        Hagel, and Mr. Hatch):
  S. 469. A bill to amend the Internal Revenue Code of 1986 to exclude 
from gross income the gain from the sale of a principal residence by 
certain employees of the intelligence community; to the Committee on 
Finance.
  Mr. ROCKEFELLER. Mr. President, today I am introducing legislation to 
extend an important tax benefit to the men and women of the United 
States Intelligence Community. I am pleased that in keeping with the 
bipartisan traditions of the Intelligence Committee, every member, 
Republican and Democrat, is listed as an original cosponsor.
  Two years ago, on Veterans Day, President Bush signed into law an 
important modification to our tax code to ensure that it does not 
punish those who serve our country in the military and in the U.S. 
foreign service. Unfortunately, that legislation did not extend to 
intelligence officers, who serve alongside their military and 
diplomatic colleagues all around the world and who often face the same 
tax issues encountered by those individuals. The legislation I am 
introducing today makes a common sense modification to the capital 
gains tax exclusion rules to ensure that when selling their homes, 
intelligence officers do not pay more tax than they would if they did 
not serve their country.
  The men and women of the Intelligence Community, serve with the 
military in Iraq, Afghanistan, Korea, and numerous other locations 
where we have U.S. forces deployed. They also serve in U.S. Embassies 
around the world. Often times they carry an added burden because they 
must serve undercover. Their families and friends don't know what they 
do. They live their cover story by day and perform their critical 
intelligence work by night. They work for all fifteen of the agencies 
included in the intelligence community and they do a remarkable job. 
These people are dedicated to their mission and to this country.
  These patriotic individuals sacrifice a great deal on behalf of the 
rest of us. They uproot and relocate their families every few years. 
They often live in places most of us wouldn't even visit. And they 
rarely have the quality of life with access to modern luxuries that the 
rest of us take for granted. To then say that they are going to be 
penalized by our tax code is unacceptable.
  Since 1997, our tax code has allowed Americans to sell their homes 
without paying taxes on up to $250,000 of capital gains. Married 
couples can exclude $500,000 in capital gains from taxation. This 
provision is specifically intended only for principle residences, and 
therefore, sellers are required to have lived in the homes for at least 
2 of the 5 years prior to sale.
  In 2003, Congress recognized that this residency requirement was 
often difficult for members of the armed forces and foreign service to 
satisfy. If they had been stationed away from home while serving their 
country, they were essentially punished with higher taxes on the sales 
of their homes. Congress addressed this injustice by allowing service 
personnel and foreign service officers who were stationed away from 
home to suspend the residency requirement for as many as ten years. 
This change allows, for example, a soldier who spent the last 7 years 
stationed in Germany to exclude from taxes the capital gains on the 
sale of his former home in the U.S., as long as he had lived in it for 
at least 2 of the 5 years prior to his service overseas. The change is 
effective on all sales after 1997, when the capital gains tax exclusion 
for home sales was provided to all Americans.
  Fairness demands that Congress apply the same rules to intelligence 
officers serving their country away from home. My legislation simply 
inserts intelligence officers into the list of those allowed to suspend 
the 5 year residency test period for up to 10 years while they are 
stationed away from home.
  I intend to work with my colleagues on the Intelligence Committee and 
the Finance Committee to ensure that this provision is enacted this 
year.
                                 ______
                                 
      By Mr. DODD (for himself, Mr. Grassley, Mr. Johnson, and Mr. 
        Wyden):
  S. 470. A bill to amend the Public Health Service Act to expand the 
clinical trials drug data bank; to the Committee on Health, Education, 
Labor, and Pensions.
  Mr. DODD. Mr. President, I rise today to introduce the Fair Access to 
Clinical Trials, FACT, Act. I want to begin by thanking Senator 
Grassley, Senator Johnson, and Senator Wyden for joining me in 
introducing this legislation. Our bill will create an electronic 
databanks for clinical trials of drugs, biological products, and 
medical devices. Such a databank will ensure that physicians, 
researchers, the general public, and patients seeking to enroll in 
clinical trials have access to basic information about those trials. It 
will require manufacturers and other researchers to reveal the results 
of clinical trials so that clinically important information will be 
available to all Americans, and physicians will have all the necessary 
information to make appropriate treatment decisions for their patients.
  Events of the past year have made it clear that such a databank is 
needed. First, serious questions were raised about the effectiveness 
and safety of antidepressants when used in children and youth. It has 
now become clear that the existing data indicates that these drugs may 
very well put children at risk. However, because the data from 
antidepressant clinical trials was not publicly available, it took 
years for this risk to be realized. In the meantime, millions of 
children have been prescribed antidepressants by well-meaning 
physicians. While these drugs undoubtedly helped many of these 
children, they also led to greater suffering for others. Recently, it 
has been suggested that the risk of antidepressants might even extend 
beyond children.
  The news is similarly disturbing for a popular class of painkillers 
known as Cox-2 inhibitors. These medicines, taken by millions of 
Americans, have been associated with an increased risk of 
cardiovascular adverse events, such as heart attack and stroke. It has 
been suggested that one of these medicines, which has since been pulled 
from the market, may be responsible for tens of thousands of deaths.
  Unfortunately, antidepressants and Cox-2 inhibitors are just two 
examples of a story that has become all too common. It has been 
suggested that negative data might actually have been suppressed; and 
if this is discovered to be the case, those responsible should be dealt 
with harshly. However, because of what is known as ``publication 
bias,'' the information available to the public and physicians can be 
misleading even without nefarious motives. The simple fact is that a 
study with a positive result is far more likely to be published, and 
thus publicly available, than a study with a negative result. 
Physicians and patients hear the good news, but rarely the bad news. In 
the end, the imbalance of available information hurts patients.
  Our bill would correct the imbalance of information, and prevent 
manufacturers from suppressing negative data. It would do so by 
creating a two-part databank, consisting of an expansion of 
clinicaltrials.gov--an existing registry that is operated by the 
National Library of Medicine, NLM--and a new database for clinical 
trial results.
  Under the FACT Act, the registry would continue to operate as a 
resource for patients seeking to enroll in clinical trials for drugs 
and biological products intended to treat serious or life-threatening 
conditions--and for the first time, it would also include medical 
device trials. The new results database would include all trials, 
except for preliminary safety trials, and would require the submission 
of results data.
  Our legislation would enforce the requirement to submit information 
to

[[Page 2975]]

the databank in two ways. First, by requiring registration as a 
condition of Institutional Review Board, IRB, approval, no trial could 
begin without submitting preliminary information to the registry and 
database. This information would include the purpose of the trial, the 
estimated date of trial completion, as well as all of the information 
necessary to help patients to enroll in the trial.
  Once the trial is completed, the researcher or manufacturer would be 
required to submit the results to the database. If they refuse to do 
so, they would be subject to monetary penalties or, in the case of 
federally funded research, a restriction on future funding. It is my 
belief that these enforcement mechanisms will ensure broad compliance. 
However, in the rare case where a manufacturer does not comply, this 
legislation also gives the Food and Drug Administration, FDA, the 
authority to publicize the required information.
  Let me also say that any time you are collecting large amounts of 
data and making it public, protecting patient privacy and 
confidentiality must be paramount. Our legislation would in no way 
threaten that privacy. The simple fact is that under this bill, no 
individually identifiable information would be available to the public.
  I believe that the establishment of a clinical trials databank is 
absolutely necessary for the health and well-being of the American 
public. But I would also like to highlight two other benefits that such 
a databank will have. First, it has the potential to reduce health care 
costs. Studies have shown that publication bias also leads to a bias 
toward new and more expensive treatment options. A databank could help 
make it clear that, in some cases, less expensive treatments are just 
as effective for patients.
  In addition, a databank will ensure that the sacrifice made by 
patients who enroll in clinical trials is not squandered. Many patients 
would be less willing to participate in trials if they understood that 
the data are unlikely to be made public if the results of the trial are 
negative. We owe it to patients to make sure that their participation 
in a trial will benefit other individuals suffering from the same 
illness or condition.
  The problems associated with publication bias have recently drawn 
more attention from the medical community, and there is broad consensus 
that a clinical trials registry is one of the best ways to address the 
issue. Accordingly, the American Medical Association, AMA, has 
recommended the creation of such a databank, and the major medical 
journals have established a policy that they will only publish the 
results of trials that were registered in a public database before the 
trial began. Our legislation meets all of the minimum criteria for a 
trial registry set out by the International Committee of Medical 
Journal Editors.
  To its credit, the pharmaceutical industry has also acknowledged the 
problem, and has created a database to which manufacturers can 
voluntarily submit clinical trials data. I applaud this step. However, 
if our objective is to provide the public with a complete and 
consistent supply of information, a voluntary database is unlikely to 
achieve that goal. Some companies will provide information, but others 
may decide not to participate. We need a clinical trials framework that 
is not just fair to all companies, but provides patients with peace of 
mind that they will receive complete information about the medicines 
they rely on.
  The American drug industry is an extraordinary success story. As a 
result of the innovations that this industry has spawned, millions of 
lives have been improved and saved in our country and around the globe. 
Because of the importance of these medicines to our health and well-
being, I have consistently supported sound public policies to help the 
industry to succeed. This legislation aims to build upon the successes 
of this industry, and help ensure that the positive changes to our 
health care system that prescription drugs have brought are not 
undermined by controversies such as the ones now surrounding 
antidepressants and Cox-2 inhibitors, which are at least in part based 
on a lack of public information. This bill will help ensure that well-
informed patients will use new and innovative medicines.
  I look forward to working with industry, physicians, the medical 
journals, patient groups, and my colleagues--including the Chairman and 
the Ranking Member of the Health, Education, Labor, and Pensions 
Committee, Senator Enzi and Senator Kennedy--to move this legislation 
forward. This bill has already been endorsed by the National 
Organization for Rare Disorders, Consumers Union, the Elizabeth Glaser 
Pediatric AIDS Foundation, the American Academy of Child and Adolescent 
Psychiatry, the American Psychiatric Association, the New England 
Journal of Medicine, and the National Women's Health Network. I thank 
these organizations for lending their expertise as we crafted this 
legislation.
  The creation of a clinical trials databank is a critical step toward 
ensuring the safety of drugs, biological products, and devices in this 
country--but it should not be the end of our efforts. I believe that 
other steps are necessary to fully restore patient confidence in the 
safety of the medicines they rely on. I have already announced my 
intention to introduce another piece of legislation that will create an 
Office of Patient Protection within the FDA, which will be responsible 
for ensuring the safety of prescription drugs once they are on the 
market. I look forward to introducing this bill in the coming weeks.
  Clinical trials are critical to protecting the safety and health of 
the American public, and for this reason, trial results must not be 
treated as information that can be hidden from scrutiny. Recent events 
have made it clear that a clinical trials databank is needed. Patients 
and physicians agree that such a databank is in the interest of the 
public health. I urge my colleagues to support this legislation, and I 
am hopeful that it will become law as soon as possible.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 470

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Fair Access to Clinical 
     Trials Act of 2005'' or the ``FACT Act''.

     SEC. 2. PURPOSE.

       It is the purpose of this Act--
       (1) to create a publicly accessible national data bank of 
     clinical trial information comprised of a clinical trial 
     registry and a clinical trial results database;
       (2) to foster transparency and accountability in health-
     related intervention research and development;
       (3) to maintain a clinical trial registry accessible to 
     patients and health care practitioners seeking information 
     related to ongoing clinical trials for serious or life-
     threatening diseases and conditions; and
       (4) to establish a clinical trials results database of all 
     publicly and privately funded clinical trial results 
     regardless of outcome, that is accessible to the scientific 
     community, health care practitioners, and members of the 
     public.

     SEC. 3. CLINICAL TRIALS DATA BANK.

       (a) In General.--Section 402(j) of the Public Health 
     Service Act (42 U.S.C. 282(j)) is amended--
       (1) in paragraph (1)(A), by striking ``for drugs for 
     serious or life-threatening diseases and conditions'';
       (2) in paragraph (2), by striking ``available to 
     individuals with serious'' and all that follows through the 
     period and inserting ``accessible to patients, other members 
     of the public, health care practitioners, researchers and the 
     scientific community. In making information about clinical 
     trials publicly available, the Secretary shall seek to be as 
     timely and transparent as possible.'';
       (3) by redesignating paragraphs (4) and (5), as paragraphs 
     (8) and (9), respectively;
       (4) by striking paragraph (3) and inserting the following:
       ``(3) The data bank shall include the following:
       ``(A)(i) A registry of clinical trials (in this 
     subparagraph referred to as the `registry') of health-related 
     interventions (whether federally or privately funded).
       ``(ii) The registry shall include information for all 
     clinical trials conducted to test the safety or effectiveness 
     (including comparative effectiveness) of any drug, biological

[[Page 2976]]

     product, or device (including those drugs, biological 
     products, or devices approved or cleared by the Secretary) 
     intended to treat serious or life-threatening diseases and 
     conditions, except those Phase I clinical trials conducted to 
     test solely the safety of an unapproved drug or unlicensed 
     biological product, or pilot or feasibility studies conducted 
     to confirm the design and operating specifications of an 
     unapproved or not yet cleared medical device. For purposes of 
     this section, Phase I clinical trials are trials described in 
     section 313.12(a) of title 21, Code of Federal Regulations 
     (or any successor regulations).
       ``(iii) The registry may include information for--
       ``(I) Phase I clinical trials conducted to test solely the 
     safety of an unapproved drug or unlicensed biological 
     product, or pilot or feasibility studies conducted to confirm 
     the design and operating specifications of an unapproved or 
     not yet cleared medical device with the consent of the 
     responsible person; and
       ``(II) clinical trials of other health-related 
     interventions with the consent of the responsible person.
       ``(iv) The information to be included in the registry under 
     this subparagraph shall include the following:
       ``(I) Descriptive information, including a brief title, 
     trial description in lay terminology, trial phase, trial 
     type, trial purpose, description of the primary and secondary 
     clinical outcome measures to be examined in the trial, the 
     time at which the outcome measures will be assessed, and the 
     dates and details of any revisions to such outcomes.
       ``(II) Recruitment information, including eligibility and 
     exclusion criteria, a description of whether, and through 
     what procedure, the manufacturer or sponsor of the 
     investigation of a new drug will respond to requests for 
     protocol exception, with appropriate safeguards, for single-
     patient and expanded protocol use of the new drug, 
     particularly in children, a statement as to whether the trial 
     is closed to enrollment of new patients, overall trial 
     status, individual site status, and estimated completion 
     date. For purposes of this section the term `completion date' 
     means the date of the last visit by subjects in the trial for 
     the outcomes described in subclause (I).
       ``(III) Location and contact information, including the 
     identity of the responsible person.
       ``(IV) Administrative data, including the study sponsor and 
     the study funding source.
       ``(V) Information pertaining to experimental treatments for 
     serious or life threatening diseases and conditions (whether 
     federally or privately funded) that may be available--
       ``(aa) under a treatment investigational new drug 
     application that has been submitted to the Secretary under 
     section 360bbb(c) of title 21, Code of Federal Regulations; 
     or
       ``(bb) as a Group C cancer drug (as defined by the National 
     Cancer Institute).
       ``(B)(i) A clinical trials results database (in this 
     subparagraph referred to as the `database') of health-related 
     interventions (whether federally or privately funded).
       ``(ii) The database shall include information for all 
     clinical trials conducted to test the safety or effectiveness 
     (including comparative effectiveness) of any drug, biological 
     product, or device (including those drugs, biological 
     products, or devices approved or cleared by the Secretary), 
     except those Phase I clinical trials conducted to test solely 
     the safety of an unapproved drug or unlicensed biological 
     product, or pilot or feasibility studies conducted to confirm 
     the design and operating specifications of an unapproved or 
     not yet cleared medical device.
       ``(iii) The database may include information for--
       ``(I) Phase I clinical trials conducted to test solely the 
     safety of an unapproved drug or unlicensed biological 
     product, or pilot or feasibility studies conducted to confirm 
     the design and operating specifications of an unapproved or 
     not yet cleared medical device with the consent of the 
     responsible person; and
       ``(II) clinical trials of other health-related 
     interventions with the consent of the responsible person.
       ``(iv) The information to be included in the database under 
     this subparagraph shall include the following:
       ``(I) Descriptive information, including--
       ``(aa) a brief title;
       ``(bb) the drug, biological product or device to be tested;
       ``(cc) a trial description in lay terminology;
       ``(dd) the trial phase;
       ``(ee) the trial type;
       ``(gg) the trial purpose;
       ``(hh) the estimated completion date for the trial; and
       ``(ii) the study sponsor and the study funding source.
       ``(II) A description of the primary and secondary clinical 
     outcome measures to be examined in the trial, the time at 
     which the outcome measures will be assessed, and the dates 
     and details of any revisions to such outcomes.
       ``(III) The actual completion date of the trial and the 
     reasons for any difference from such actual date and the 
     estimated completion date submitted pursuant to subclause 
     (I)(hh). If the trial is not completed, the termination date 
     and reasons for such termination.
       ``(IV) A summary of the results of the trial in a standard, 
     non-promotional summary format (such as ICHE3 template form), 
     including the trial design and methodology, results of the 
     primary and secondary outcome measures as described in 
     subclause (II), summary data tables with respect to the 
     primary and secondary outcome measures, including information 
     on the statistical significance or lack thereof of such 
     results.
       ``(V) Safety data concerning the trial (including a summary 
     of all adverse events specifying the number and type of such 
     events, data on prespecified adverse events, data on serious 
     adverse events, and data on overall deaths).
       ``(VI) Any publications in peer reviewed journals relating 
     to the trial. If the trial results are published in a peer 
     reviewed journal, the database shall include a citation to 
     and, when available, a link to the journal article.
       ``(VII) A description of the process used to review the 
     results of the trial, including a statement about whether the 
     results have been peer reviewed by reviewers independent of 
     the trial sponsor.
       ``(VIII) If the trial addresses the safety, effectiveness, 
     or benefit of a use not described in the approved labeling 
     for the drug, biological product, or device, a statement, as 
     appropriate, displayed prominently at the beginning of the 
     data in the registry with respect to the trial, that the Food 
     and Drug Administration--
       ``(aa) is currently reviewing an application for approval 
     of such use to determine whether the use is safe and 
     effective;
       ``(bb) has disapproved an application for approval of such 
     use;
       ``(cc) has reviewed an application for approval of such use 
     but the application was withdrawn prior to approval or 
     disapproval; or
       ``(dd) has not reviewed or approved such use as safe and 
     effective.
       ``(IX) If data from the trial has not been submitted to the 
     Food and Drug Administration, an explanation of why it has 
     not been submitted.
       ``(X) A description of the protocol used in such trial to 
     the extent necessary to evaluate the results of such trial.
       ``(4)(A) Not later than 90 days after the date of the 
     completion of the review by the Food and Drug Administration 
     of information submitted by a sponsor in support of a new 
     drug application, or a supplemental new drug application, 
     whether or not approved by the Food and Drug Administration, 
     the Commissioner of Food and Drugs shall make available to 
     the public the full reviews conducted by the Administration 
     of such application.
       ``(B) Not later than 90 days after the date of the 
     completion of a written consultation on a drug concerning the 
     drug's safety conducted by the Office of Drug Safety, 
     regardless of whether initiated by such Office or outside of 
     the Office, the Commissioner of Food and Drugs shall make 
     available to the public a copy of such consultation in full.
       ``(C) Nothing in this paragraph shall be construed to alter 
     or amend section 301(j) or section 1905 of title 18, United 
     States Code.
       ``(D) This paragraph shall supersede section 552 of title 
     5, United States Code.
       ``(5) The information described in subparagraphs (A) and 
     (B) of paragraph (3) shall be in a format that can be readily 
     accessed and understood by members of the general public, 
     including patients seeking to enroll as subjects in clinical 
     trials.
       ``(6) The Secretary shall assign each clinical trial a 
     unique identifier to be included in the registry and in the 
     database described in subparagraphs (A) and (B) of paragraph 
     (3). To the extent practicable, this identifier shall be 
     consistent with other internationally recognized and used 
     identifiers.
       ``(7) To the extent practicable, the Secretary shall ensure 
     that where the same information is required for the registry 
     and the database described in subparagraphs (A) and (B) of 
     paragraph (3), a process exists to allow the responsible 
     person to make only one submission.''; and
       (5) by adding at the end the following:
       ``(10) In this section, the term `clinical trial' with 
     respect to the registry and the database described in 
     subparagraphs (A) and (B) of paragraph (3) means a research 
     study in human volunteers to answer specific health 
     questions, including treatment trials, prevention trials, 
     diagnostic trials, screening trials, and quality of life 
     trials.''.
       (b) Actions of Secretary Regarding Clinical Trials.--
     Section 402 of the Public Health Service Act (42 U.S.C. 282) 
     is amended--
       (1) by redesignating subsections (k) and (l) as subsections 
     (q) and (r), respectively; and
       (2) by inserting after subsection (j), the following:
       ``(k) Federally Supported Trials.--
       ``(1) All federally supported trials.--With respect to any 
     clinical trial described in subsection (j)(3)(B) that is 
     supported solely by a grant, contract, or cooperative 
     agreement awarded by the Secretary, the principal 
     investigator of such trial shall, not later than the date 
     specified in paragraph (2), submit to the Secretary--

[[Page 2977]]

       ``(A) the information described in subclauses (II) through 
     (X) of subsection (j)(3)(B)(iv), and with respect to clinical 
     trials in progress on the date of enactment of the FACT Act, 
     the information described in subclause (I) of subsection 
     (j)(3)(B)(iv); or
       ``(B) a statement containing information sufficient to 
     demonstrate to the Secretary that the information described 
     in subparagraph (A) cannot reasonably be submitted, along 
     with an estimated date of submission of the information 
     described in such subparagraph.
       ``(2) Date specified.--The date specified in this paragraph 
     shall be the date that is 1 year from the earlier of--
       ``(A) the estimated completion date of the trial, as 
     submitted under subsection (j)(3)(B)(vi)(I)(hh); or
       ``(B) the actual date of the completion or termination of 
     the trial.
       ``(3) Condition of federal grants, contracts, and 
     cooperative agreements.--
       ``(A) Certification of compliance.--To be eligible to 
     receive a grant, contract, or cooperative agreement from the 
     Secretary for the conduct or support of a clinical trial 
     described in subsection (j)(3)(B), the principal investigator 
     involved shall certify to the Secretary that--
       ``(i) such investigator shall submit data to the Secretary 
     in accordance with this subsection; and
       ``(ii) such investigator has complied with the requirements 
     of this subsection with respect to other clinical trials 
     conducted by such investigator after the date of enactment of 
     the FACT Act.
       ``(B) Failure to submit certification.--An investigator 
     that fails to submit a certification as required under 
     subparagraph (A) shall not be eligible to receive a grant, 
     contract, or cooperative agreement from the Secretary for the 
     conduct or support of a clinical trial described in 
     subsection (j)(3)(B).
       ``(C) Failure to comply with certification.--If, by the 
     date specified in paragraph (2), the Secretary has not 
     received the information or statement described in paragraph 
     (1), the Secretary shall--
       ``(i) transmit to the principal investigator involved a 
     notice specifying the information or statement required to be 
     submitted to the Secretary and stating that such investigator 
     shall not be eligible to receive further funding from the 
     Secretary if such information or statement is not submitted 
     to the Secretary within 30 days of the date on which such 
     notice is transmitted; and
       ``(ii) include and prominently display, until such time as 
     the Secretary receives the information or statement described 
     in paragraph (1), as part of the record of such trial in the 
     database described in subsection (j), a notice stating that 
     the results of such trials have not been reported as required 
     by law.
       ``(D) Failure to comply with notice.--If by the date that 
     is 30 days after the date on which the notice described in 
     subparagraph (C) is transmitted, the Secretary has not 
     received from the principal investigator involved the 
     information or statement required pursuant to such notice, 
     the Secretary may not award a grant, contract, cooperative 
     agreement, or any other award to such principal investigator 
     until such principal investigator submits to the Secretary 
     the information or statement required pursuant to such 
     notice.
       ``(E) Submission of statement but not information.--
       ``(i) In general.--If by the date specified in paragraph 
     (2), the Secretary has received a statement described in 
     paragraph (1)(B) but not the information described in 
     paragraph (1)(A), the Secretary shall transmit to the 
     principal investigator involved a notice stating that such 
     investigator shall submit such information by the date 
     determined by the Secretary in consultation with such 
     investigator.
       ``(ii) Failure to comply with certification.--If, by the 
     date specified by the Secretary in the notice under clause 
     (i), the Secretary has not received the information described 
     in paragraph (1)(B), the Secretary shall--

       ``(I) transmit to the principal investigator involved a 
     notice specifying the information required to be submitted to 
     the Secretary and stating that such investigator shall not be 
     eligible to receive further funding from the Secretary if 
     such information is not submitted to the Secretary within 30 
     days of the date on which such notice is transmitted; and
       ``(II) include and prominently display, until such time as 
     the Secretary receives the information described in paragraph 
     (1)(B), as part of the record of such trial in the database 
     described in subsection (j), a notice stating that the 
     results of such trials have not been reported as required by 
     law.

       ``(F) Failure to comply with notice.--If by the date that 
     is 30 days after the date on which the notice described in 
     subparagraph (E)(ii)(I) is transmitted, the Secretary has not 
     received from the principal investigator involved the 
     information required pursuant to such notice, the Secretary 
     may not award a grant, contract, cooperative agreement, or 
     any other award to such principal investigator until such 
     principal investigator submits to the Secretary the 
     information required pursuant to such notice.
       ``(G) Rule of construction.--For purposes of this 
     paragraph, limitations on the awarding of grants, contracts, 
     cooperative agreements, or any other awards to principal 
     investigators for violations of this paragraph shall not be 
     construed to include any funding that supports the clinical 
     trial involved.
       ``(4) Rule of construction.--Nothing in this subsection 
     shall be construed to prevent an investigator other than the 
     investigator described in paragraph (3)(F) from receiving an 
     ongoing award, contract, or cooperative agreement.
       ``(5) Inclusion in registry.--
       ``(A) General rule.--The Secretary shall, pursuant to 
     subsection (j)(5), include--
       ``(i) the data described in subsection (j)(3)(A) and 
     submitted under the amendments made by section 4(a) of the 
     FACT Act in the registry described in subsection (j) as soon 
     as practicable after receiving such data; and
       ``(ii) the data described in clause (I) of subsection 
     (j)(3)(B)(iv) and submitted under this subsection or the 
     amendments made by section 4(a) of the FACT Act in the 
     database described in subsection (j) as soon as practicable 
     after receiving such data.
       ``(B) Other data.--
       ``(i) In general.--The Secretary shall, pursuant to 
     subsection (j)(5), include the data described in subclauses 
     (II) through (X) of subsection (j)(3)(B)(iv) and submitted 
     under this section in the database described in subsection 
     (j)--

       ``(I) as soon as practicable after receiving such data; or
       ``(II) in the case of data to which clause (ii) applies, by 
     the date described in clause (iii).

       ``(ii) Data described.--This clause applies to data 
     described in clause (i) if--

       ``(I) the principal investigator involved requests a delay 
     in the inclusion in the database of such data in order to 
     have such data published in a peer reviewed journal; and
       ``(II) the Secretary determines that an attempt will be 
     made to seek such publication.

       ``(iii) Date for inclusion in registry.--Subject to clause 
     (iv), the date described in this clause is the earlier of--

       ``(I) the date on which the data involved is published as 
     provided for in clause (ii); or
       ``(II) the date that is 18 months after the date on which 
     such data is submitted to the Secretary.

       ``(iv) Extension of date.--The Secretary may extend the 18-
     month period described in clause (iii)(II) for an additional 
     6 months if the principal investigator demonstrates to the 
     Secretary, prior to the expiration of such 18-month period, 
     that the data involved has been accepted for publication by a 
     journal described in clause (ii)(I).
       ``(v) Modification of data.--Prior to including data in the 
     database under clause (ii) or (iv), the Secretary shall 
     permit the principal investigator to modify the data 
     involved.
       ``(6) Memorandum of understanding.--Not later than 6 months 
     after the date of enactment of the FACT Act, the Secretary 
     shall seek a memorandum of understanding with the heads of 
     all other Federal agencies that conduct clinical trials to 
     include in the registry and the database clinical trials 
     sponsored by such agencies that meet the requirements of this 
     subsection.
       ``(7) Application to certain persons.--The provisions of 
     this subsection shall apply to a responsible person described 
     in subsections (p)(1)(A)(ii)(II) or (p)(1)(B)(i)(II).
       ``(l) Trials With Non-Federal Support.--
       ``(1) In general.--The responsible person for a clinical 
     trial described in subsection (j)(3)(B) shall, not later than 
     the date specified in paragraph (3), submit to the 
     Secretary--
       ``(A) the information described in subclauses (II) through 
     (X) of subsection (j)(3)(B)(iv), and with respect to clinical 
     trials in progress on the date of enactment of the FACT Act, 
     the information described in subclause (I) of subsection 
     (j)(3)(B)(iv); or
       ``(B) a statement containing information sufficient to 
     demonstrate to the Secretary that the information described 
     in subparagraph (A) cannot reasonably be submitted, along 
     with an estimated date of submission of the information 
     described in such subparagraph.
       ``(2) Sanction in case of noncompliance.--
       ``(A) Initial noncompliance.--If by the date specified in 
     paragraph (3), the Secretary has not received the information 
     or statement required to be submitted to the Secretary under 
     paragraph (1), the Secretary shall--
       ``(i) transmit to the responsible person for such trial a 
     notice stating that such responsible person shall be liable 
     for the civil monetary penalties described in subparagraph 
     (B) if the required information or statement is not submitted 
     to the Secretary within 30 days of the date on which such 
     notice is transmitted; and
       ``(ii) include and prominently display, until such time as 
     the Secretary receives the information described in paragraph 
     (1), as part of the record of such trial in the database 
     described in subsection (j), a notice stating that the 
     results of such trials have not been reported as required by 
     law.
       ``(B) Civil monetary penalties for noncompliance.--
       ``(i) In general.--If by the date that is 30 days after the 
     date on which a notice described in subparagraph (A) is 
     transmitted,

[[Page 2978]]

     the Secretary has not received from the responsible person 
     involved the information or statement required pursuant to 
     such notice, the Secretary shall, after providing the 
     opportunity for a hearing, order such responsible person to 
     pay a civil penalty of $10,000 for each day after such date 
     that the information or statement is not submitted.
       ``(ii) Waivers.--In any case in which a responsible person 
     described in clause (i) is a nonprofit entity, the Secretary 
     may waive or reduce the penalties applicable under such 
     clause to such person.
       ``(C) Submission of statement but not information.--
       ``(i) In general.--If by the date specified in paragraph 
     (3), the Secretary has received a statement described in 
     paragraph (1)(B) but not the information described in 
     paragraph (1)(A) the Secretary shall transmit to the 
     responsible person involved a notice stating that such 
     responsible person shall submit such information by the date 
     determined by the Secretary in consultation with such 
     responsible person.
       ``(ii) Failure to comply.--If, by the date specified by the 
     Secretary in the notice under clause (i), the Secretary has 
     not received the information described in paragraph (1)(A), 
     the Secretary shall--

       ``(I) transmit to the responsible person involved a notice 
     specifying the information required to be submitted to the 
     Secretary and stating that such responsible person shall be 
     liable for the civil monetary penalties described in 
     subparagraph (D) if such information is not submitted to the 
     Secretary within 30 days of the date on which such notice is 
     transmitted; and
       ``(II) include and prominently display, until such time as 
     the Secretary receives the information described in paragraph 
     (1)(A), as part of the record of such trial in the database 
     described in subsection (j), a notice stating that the 
     results of such trials have not been reported as required by 
     law.

       ``(D) Noncompliance.--
       ``(i) In general.--If by the date that is 30 days after the 
     date on which a notice described in subparagraph (C)(ii)(I) 
     is transmitted, the Secretary has not received from the 
     responsible person involved the information required pursuant 
     to such notice, the Secretary, after providing the 
     opportunity for a hearing, order such responsible person to 
     pay a civil penalty of $10,000 for each day after such date 
     that the information is not submitted.
       ``(ii) Waivers.--In any case in which a responsible person 
     described in clause (i) is a nonprofit entity, the Secretary 
     may waive or reduce the penalties applicable under such 
     clause to such person.
       ``(E) Notice of publication of data.--If the responsible 
     person is the manufacturer or distributor of the drug, 
     biological product, or device involved, the notice under 
     subparagraphs (A)(i) and (C)(ii)(I) shall include a notice 
     that the Secretary shall publish the data described in 
     subsection (j)(3)(B) in the database if the responsible 
     person has not submitted the information specified in the 
     notice transmitted by the date that is 6 months after the 
     date of such notice.
       ``(F) Publication of data.--Notwithstanding section 301(j) 
     of the Federal Food, Drug, and Cosmetic Act, section 1905 of 
     title 18, United States Code, or any other provision of law, 
     if the responsible person is the manufacturer or distributor 
     of the drug, biological product, or device involved, and if 
     the responsible person has not submitted to the Secretary the 
     information specified in a notice transmitted pursuant to 
     subparagraph (A)(i) or (C)(ii)(I) by the date that is 6 
     months after the date of such notice, the Secretary shall 
     publish in the registry information that--
       ``(i) is described in subsection (j)(3)(B); and
       ``(ii) the responsible person has submitted to the 
     Secretary in any application, including a supplemental 
     application, for the drug or device under section 505, 510, 
     515, or 520 of the Federal Food, Drug, and Cosmetic Act or 
     for the biological product under section 351.
       ``(3) Date specified.--The date specified in this paragraph 
     shall be the date that is 1 year from the earlier of--
       ``(A) the estimated completion date of the trial, submitted 
     under subsection (j)(3)(B)(vi)(I)(hh); or
       ``(B) the actual date of completion or termination of the 
     trial.
       ``(4) Use of funds.--
       ``(A) In general.--The Secretary shall deposit the funds 
     collected under paragraph (2) into an account and use such 
     funds, in consultation with the Director of the Agency for 
     Healthcare Research and Quality, to fund studies that compare 
     the clinical effectiveness of 2 or more treatments for a 
     disease or condition.
       ``(B) Funding decisions.--The Secretary shall award funding 
     under subparagraph (A) based on a priority list established 
     not later than 6 months after the date of enactment of the 
     FACT Act by the Director of the Agency for Healthcare 
     Research and Quality and periodically updated as determined 
     appropriate by the Director.
       ``(5) Inclusion in registry.--
       ``(A) General rule.--The Secretary shall, pursuant to 
     subsection (j)(5), include--
       ``(i) the data described in subsection (j)(3)(A) and 
     submitted under the amendments made by section 4(a) of the 
     FACT Act in the registry described in subsection (j) as soon 
     as practicable after receiving such data; and
       ``(ii) the data described in clause (I) of subsection 
     (j)(3)(B)(iv) and submitted under this subsection in the 
     database described in subsection (j) as soon as practicable 
     after receiving such data
       ``(B) Other data.--
       ``(i) In general.--The Secretary shall, pursuant to 
     subsection (j)(5), include the data described in subclauses 
     (II) through (X) of subsection (j)(3)(B)(iv) and submitted 
     under this section in the database described in subsection 
     (j)--

       ``(I) as soon as practicable after receiving such data; or
       ``(II) in the case of data to which clause (ii) applies, by 
     the date described in clause (iii).

       ``(ii) Data described.--This clause applies to data 
     described in clause (i) if--

       ``(I) the responsible person involved requests a delay in 
     the inclusion in the database of such data in order to have 
     such data published in a peer reviewed journal; and
       ``(II) the Secretary determines that an attempt will be 
     made to seek such publication.

       ``(iii) Date for inclusion in registry.--Subject to clause 
     (iv), the date described in this clause is the earlier of--

       ``(I) the date on which the data involved is published as 
     provided for in clause (ii); or
       ``(II) the date that is 18 months after the date on which 
     such data is submitted to the Secretary.

       ``(iv) Extension of date.--The Secretary may extend the 18-
     month period described in clause (iii)(II) for an additional 
     6 months if the responsible person demonstrates to the 
     Secretary, prior to the expiration of such 18-month period, 
     that the data involved has been accepted for publication by a 
     journal described in clause (ii)(I).
       ``(v) Modification of data.--Prior to including data in the 
     database under clause (ii) or (iv), the Secretary shall 
     permit the responsible person to modify the data involved.
       ``(6) Effect.--The information with respect to a clinical 
     trial submitted to the Secretary under this subsection, 
     including data published by the Secretary pursuant to 
     paragraph (2)(F), may not be submitted by a person other than 
     the responsible person as part of, or referred to in, an 
     application for approval of a drug or device under section 
     505, 510, 515, or 520 of the Federal Food, Drug, and Cosmetic 
     Act or of a biological product under section 351, unless the 
     information is available from a source other than the 
     registry or database described in subsection (j).
       ``(m) Procedures and Waivers.--
       ``(1) Submission prior to notice.--Nothing in subsections 
     (k) through (l) shall be construed to prevent a principal 
     investigator or a responsible person from submitting any 
     information required under this subsection to the Secretary 
     prior to receiving any notice described in such subsections.
       ``(2) Ongoing trials.--A factually accurate statement that 
     a clinical trial is ongoing shall be deemed to be information 
     sufficient to demonstrate to the Secretary that the 
     information described in subsections (k)(1)(A) and (l)(1)(A) 
     cannot reasonably be submitted.
       ``(3) Information previously submitted.--Nothing in 
     subsections (k) through (l) shall be construed to require the 
     Secretary to send a notice to any principal investigator or 
     responsible person requiring the submission to the Secretary 
     of information that has already been submitted.
       ``(4) Submission format and technical standards.--
       ``(A) In general.--The Secretary shall, to the extent 
     practicable, accept submissions required under this 
     subsection in an electronic format and shall establish 
     interoperable technical standards for such submissions.
       ``(B) Consistency of standards.--To the extent practicable, 
     the standards established under subparagraph (A) shall be 
     consistent with standards adopted by the Consolidated Health 
     Informatics Initiative (or a successor organization to such 
     Initiative) to the extent such Initiative (or successor) is 
     in operation.
       ``(5) Trials completed prior to enactment.--The Secretary 
     shall establish procedures and mechanisms to allow for the 
     voluntary submission to the database of the information 
     described in subsection (j)(3)(B) with respect to clinical 
     trials completed prior to the date of enactment of the FACT 
     Act. In cases in which it is in the interest of public 
     health, the Secretary may require that information from such 
     trials be submitted to the database. Failure to comply with 
     such a requirement shall be deemed to be a failure to submit 
     information as required under this section, and the 
     appropriate remedies and sanctions under this section shall 
     apply.
       ``(6) Trials not involving drugs, biological products, or 
     devices.--The Secretary shall establish procedures and 
     mechanisms to allow for the voluntary submission to the 
     database of the information described in subsection (j)(3)(B) 
     with respect to clinical trials that do not involve drugs, 
     biological products, or devices. In cases in which it is in 
     the interest of public health, the Secretary may require that 
     information from such trials be submitted to the database. 
     Failure to comply with such a requirement shall be deemed to 
     be a failure to submit information as required under this 
     section, and the appropriate remedies and sanctions under 
     this section shall apply.

[[Page 2979]]

       ``(7) Submission of inaccurate information.--
       ``(A) In general.--If the Secretary determines that 
     information submitted by a principal investigator or a 
     responsible person under this section is factually and 
     substantively inaccurate, the Secretary shall submit a notice 
     to the investigator or responsible person concerning such 
     inaccuracy that includes--
       ``(i) a summary of the inaccuracies involved; and
       ``(ii) a request for corrected information within 30 days.
       ``(B) Audit of information.--
       ``(i) In general.--The Secretary may conduct audits of any 
     information submitted under subsection (j).
       ``(ii) Requirement.--Any principal investigator or 
     responsible person that has submitted information under 
     subsection (j) shall permit the Secretary to conduct the 
     audit described in clause (i).
       ``(C) Changes to information.--Any change in the 
     information submitted by a principal investigator or a 
     responsible person under this section shall be reported to 
     the Secretary within 30 days of the date on which such 
     investigator or person became aware of the change for 
     purposes of updating the registry or the database.
       ``(D) Failure to correct.--If a principal investigator or a 
     responsible person fails to permit an audit under 
     subparagraph (B), provide corrected information pursuant to a 
     notice under subparagraph (A), or provide changed information 
     under subparagraph (C), the investigator or responsible 
     person involved shall be deemed to have failed to submit 
     information as required under this section and the 
     appropriate remedies and sanction under this section shall 
     apply.
       ``(E) Corrections.--
       ``(i) In general.--The Secretary may correct, through any 
     means deemed appropriate by the Secretary to protect public 
     health, any information included in the registry or the 
     database described in subsection (j) (including information 
     described or contained in a publication referred to under 
     subclause (VI) of subsection (j)(3)(B)(iv)) that is--

       ``(I) submitted to the Secretary for inclusion in the 
     registry or the database; and
       ``(II) factually and substantively inaccurate or false or 
     misleading.

       ``(ii) Reliance on information.--The Secretary may rely on 
     any information from a clinical trial or a report of an 
     adverse event acquired or produced under the authority of 
     section 351 of this Act or of the Federal Food, Drug, and 
     Cosmetic Act in determining whether to make corrections as 
     provided for in clause (i).
       ``(iii) Determinations relating to misleading 
     information.--For purposes of clause (i)(II), in determining 
     whether information is misleading, the Secretary shall use 
     the standard described in section 201(n) of the Federal Food, 
     Drug, and Cosmetic Act that is used to determine whether 
     labeling or advertising is misleading.
       ``(iv) Rule of construction.--This subparagraph shall not 
     be construed to authorize the disclosure of information if--

       ``(I) such disclosure would constitute an invasion of 
     personal privacy;
       ``(II) such information concerns a method or process which 
     as a trade secret is entitled to protection within the 
     meaning of section 301(j) of the Federal Food, Drug, and 
     Cosmetic Act;
       ``(III) such disclosure would disclose confidential 
     commercial information or a trade secret, other than a trade 
     secret described in subclause (II), unless such disclosure is 
     necessary--

       ``(aa) to make a correction as provided for under clause 
     (i); and
       ``(bb) protect the public health; or

       ``(IV) if such disclosure relates to a biological product 
     for which no license is in effect under section 351, a drug 
     for which no approved application is in effect under section 
     505(c) of the Federal Food, Drug, and Cosmetic Act, or a 
     device that is not cleared under section 510(k) of such Act 
     or for which no application is in effect under section 515 of 
     such Act.

       ``(v) Notice.--In the case of a disclosure under clause 
     (iv)(III), the Secretary shall notify the manufacturer or 
     distributor of the drug, biological product, or device 
     involved--

       ``(I) at least 30 days prior to such disclosure; or
       ``(II) if immediate disclosure is necessary to protect the 
     public health, concurrently with such disclosure.

       ``(8) Waivers regarding clinical trial results.--The 
     Secretary may waive the requirements of subsections (k)(1) 
     and (l)(1) that the results of clinical trials be submitted 
     to the Secretary, upon a written request from the responsible 
     person if the Secretary determines that extraordinary 
     circumstances justify the waiver and that providing the 
     waiver is in the public interest or consistent with the 
     protection of public health.
       ``(n) Trials Conducted Outside of the United States.--
       ``(1) In general.--With respect to clinical trials 
     described in paragraph (2), the responsible person shall 
     submit to the Secretary the information required under 
     subclauses (II) through (X) of subsection (j)(3)(B)(iv). 
     Failure to comply with this paragraph shall be deemed to be a 
     failure to submit information as required under this section, 
     and the appropriate remedies and sanctions under this section 
     shall apply.
       ``(2) Clinical trial described.--A clinical trial is 
     described in this paragraph if--
       ``(A) such trial is conducted outside of the United States; 
     and
       ``(B) the data from such trial is--
       ``(i) submitted to the Secretary as part of an application, 
     including a supplemental application, for a drug or device 
     under section 505, 510, 515, or 520 of the Federal Food, 
     Drug, and Cosmetic Act or for the biological product under 
     section 351; or
       ``(ii) used in advertising or labeling to make a claim 
     about the drug, device, or biological product involved.
       ``(o) Definitions; Individual Liability.--
       ``(1) Responsible person.--
       ``(A) In general.--In this section, the term `responsible 
     person' with respect to a clinical trial, means--
       ``(i) if such clinical trial is the subject of an 
     investigational new drug application or an application for an 
     investigational device exemption, the sponsor of such 
     investigational new drug application or such application for 
     an investigational device exemption; or
       ``(ii) except as provided in subparagraph (B), if such 
     clinical trial is not the subject of an investigational new 
     drug application or an application for an investigational 
     device exemption--

       ``(I) the person that provides the largest share of the 
     monetary support (such term does not include in-kind support) 
     for the conduct of such trial; or
       ``(II) in the case in which the person described in 
     subclause (I) is a Federal or State agency, the principal 
     investigator of such trial.

       ``(B) Nonprofit entities and requesting persons.--
       ``(i) Nonprofit entities.--For purposes of subparagraph 
     (A)(ii)(I), if the person that provides the largest share of 
     the monetary support for the conduct of the clinical trial 
     involved is a nonprofit entity, the responsible person for 
     purposes of this section shall be--

       ``(I) the nonprofit entity; or
       ``(II) if the nonprofit entity and the principal 
     investigator of such trial jointly certify to the Secretary 
     that the principal investigator will be responsible for 
     submitting the information described in subsection (j)(3)(B) 
     for such trial, the principal investigator.

       ``(ii) Requesting persons.--For purposes of subparagraph 
     (A)(ii)(I), if a person--

       ``(I) has submitted a request to the Secretary that the 
     Secretary recognize the person as the responsible person for 
     purposes of this section; and
       ``(II) the Secretary determines that such person--

       ``(aa) provides monetary support for the conduct of such 
     trial;
       ``(bb) is responsible for the conduct of such trial; and
       ``(cc) will be responsible for submitting the information 
     described in subsection (j)(3)(B) for such trial;
     such person shall be the responsible person for purposes of 
     this section.
       ``(2) Drug, device, biological product.--In this section--
       ``(A) the terms `drug' and `device' have the meanings given 
     such terms in section 201 of the Federal Food, Drug, and 
     Cosmetic Act; and
       ``(B) the term `biological product' has the meaning given 
     such term in section 351 of this Act.
       ``(3) Individual liability.--
       ``(A) Limitation on liability of individuals.--No 
     individual shall be liable for any civil monetary penalty 
     under this section.
       ``(B) Individuals who are responsible persons.--If a 
     responsible person under subparagraph (A) or (B) of paragraph 
     (1) is an individual, such individual shall be subject to the 
     procedures and conditions described in subsection (k).''.
       (c) Authorization of Appropriations.--Section 402 of the 
     Public Health Service Act (42 U.S.C. 282), as amended by this 
     section, is further amended by adding at the end the 
     following:
       ``(s) Authorization of Appropriations.--There are 
     authorized to be appropriated, such sums as may be necessary 
     to carry out this section.''.

     SEC. 4. REVIEW AND APPROVAL OF PROPOSALS FOR RESEARCH.

       (a) Amendments.--Section 492A(a) of the Public Health 
     Service Act (42 U.S.C. 289a-1(a)) is amended--
       (1) in paragraph (1)(A), by striking ``unless'' and all 
     that follows through the period and inserting the following: 
     ``unless--
       ``(i) the application has undergone review in accordance 
     with such section and has been recommended for approval by a 
     majority of the members of the Board conducting the review;
       ``(ii) such Board has submitted to the Secretary a 
     notification of such approval; and
       ``(iii) with respect to an application involving a clinical 
     trial to which section 402(j) applies, the principal 
     investigator who has submitted such application has submitted 
     to the Secretary for inclusion in the registry and the 
     database described in section 402(j) the information 
     described in paragraph (3)(A)

[[Page 2980]]

     and subclause (I) of paragraph (3)(B)(iv) of such section.''; 
     and
       (2) by adding at the end the following:
       ``(3) Cost recovery.--Nonprofit entities may recover the 
     full costs associated with compliance with the requirements 
     of paragraph (1) from the Secretary as a direct cost of 
     research.''.
       (b) Regulations.--The Secretary of Health and Human 
     Services shall modify the regulations promulgated at part 46 
     of title 45, Code of Federal Regulations, part 50 of title 
     21, Code of Federal Regulations, and part 56 of title 21, 
     Code of Federal Regulations, to reflect the amendments made 
     by subsection (a).

     SEC. 5. PROHIBITED ACTS.

       Section 301 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 331) is amended by adding at the end the following:
       ``(hh)(1) The entering into of a contract or other 
     agreement by a responsible person or a manufacturer of a 
     drug, biological product, or device with an individual who is 
     not an employee of such responsible person or manufacturer, 
     or the performance of any other act by such a responsible 
     person or manufacturer, that prohibits, limits, or imposes 
     unreasonable delays on the ability of such individual to--
       ``(A) discuss the results of a clinical trial at a 
     scientific meeting or any other public or private forum; or
       ``(B) publish the results of a clinical trial or a 
     description or discussion of the results of a clinical trial 
     in a scientific journal or any other publication.
       ``(2) The entering into a contract or other agreement by a 
     responsible person or a manufacturer of a drug, biological 
     product, or device with an academic institution or a health 
     care facility, or the performance of any other act by such a 
     responsible person or manufacturer, that prohibits, limits, 
     or imposes unreasonable delays on the ability of an 
     individual who is not an employee of such responsible person 
     or manufacturer to--
       ``(A) discuss the results of a clinical trial at a 
     scientific meeting or any other public or private forum; or
       ``(B) publish the results of a clinical trial or a 
     description or discussion of the results of a clinical trial 
     in a scientific journal or any other publication.''.

     SEC. 6. REPORTS.

       (a) Implementation Report.--Not later than 1 year after the 
     date of enactment of this Act, the Secretary of Health and 
     Human Services shall submit to the appropriate committees of 
     Congress a report on the status of the implementation of the 
     requirements of the amendments made by section 3 that 
     includes a description of the number and types of clinical 
     trials for which information has been submitted under such 
     amendments.
       (b) Data Collection.--
       (1) In general.--The Secretary of Health and Human Services 
     shall enter into a contract with the Institute of Medicine 
     for the conduct of a study concerning the extent to which 
     data submitted to the registry under section 402(j) of the 
     Public Health Service Act (42 U.S.C. 282(j)) has impacted the 
     public health.
       (2) Report.--Not later than 6 months after the date on 
     which a contract is entered into under paragraph (1), the 
     Institute of Medicine shall submit to the Secretary of Health 
     and Human Services a report on the results of the study 
     conducted under such paragraph. Such report shall include 
     recommendations for changes to the registry, the database, 
     and the data submission requirements that would benefit the 
     public health.

  Mr. GRASSLEY. Mr. President, earlier today, Senate Bill 470 was 
introduced. I am pleased to sponsor the Fair Access to Clinical Trials 
Act of 2005, with Senator Dodd. I am co-sponsoring this legislation as 
part of a sustained effort to restore public confidence in the Federal 
Government's food and drug safety agency. Enactment of this bill will 
be a meaningful step toward greater transparency and accountability in 
clinical trials and the scientific process.
  The Food and Drug Administration earned its prized reputation through 
decades of good work on behalf of the American people. The FDA's drug 
approval process has long been considered the ``Good Housekeeping Seal 
of Approval.'' However, the Vioxx disaster and its aftermath have 
shaken the public's confidence. American consumers demand and deserve 
assurances that the medicines in their cabinets are safe. The health 
and safety of the public must be the FDA's first and only concern. 
Unfortunately, reforms at the FDA are necessary to place that mission 
front and center once again.
  I began my oversight of the FDA last year in response to concerns 
about the reluctance of the FDA to provide information to the public 
about the increased suicidal risks for young people taking anti-
depressants. Last November, I chaired a groundbreaking hearing on drug 
safety, the FDA and Vioxx. That hearing and other critical drug safety 
concerns of the past year highlighted the need for reforms and more 
stringent oversight of the FDA.
  Sometimes congressional scrutiny of agency mismanagement can lead to 
necessary reforms. Sometimes an agency will act on its own to enhance 
its credibility. I have been pressing for reforms--both administrative 
and legislative--to bring about greater responsiveness and transparency 
at the FDA. The risks and benefits of prescription drugs should be 
readily available to patients and doctors seeking to make informed 
decisions.
  The FACT Act will expand www.clinicaltrials.gov to create a publicly 
accessible national data bank of clinical trial information comprised 
of a clinical trial registry and a clinical trial results database. The 
legislation will foster transparency and accountability in health-
related intervention research and development and ensure that the 
scientific community and the general public have access to basic 
information about clinical trials. Importantly, the FACT Act will 
maintain clinicaltrials.gov as a registry for patients and physicians 
seeking information about ongoing clinical trials for serious or life-
threatening diseases and conditions. The legislation will also prevent 
companies from withholding clinically important information about their 
products.
  The FACT Act will maintain a clinical trial registry accessible to 
patients and health care practitioners seeking information related to 
ongoing clinical trials for serious or life-threatening diseases and 
conditions; establish a clinical trials results database of all 
publicly and privately funded clinical trial results regardless of 
outcome that is accessible to the scientific community, health care 
practitioners, and members of the public; require the Food and Drug 
Administration (FDA) to make internal drug approval and safety reviews 
publicly available; build on the successful model of 
www.clinicaltrials.gov, which was established in 1997. The web site 
will continue to be run by the National Library of Medicine at the 
National Institutes of Health, with assistance from the FDA; apply to 
clinical trials for drugs, biologics, and medical devices. All trials 
must be registered in the database in order to obtain approval from a 
U.S. Institutional Review Board; require that foreign trials that are 
submitted to the FDA or used in advertising to U.S. physicians be 
registered in the database at the time of submission; require that 
researchers promptly disclose the objectives, eligibility criteria, 
sources of funding, and anticipated timeline of clinical trials. The 
bill's standards will meet all of the minimum criteria for a trial 
registry set out by the International Committee of Medical Journal 
Editors on September 8, 2004; mandate that the results of clinical 
trials be available to doctors and patients. Recognizing that the peer 
review process is the best safeguard for scientific accuracy, the bill 
provides time for researchers to publish their results. The disclosure 
of important trial results satisfies the recommendation of the American 
Medical Association; establish strong enforcement mechanisms. The bill 
will provide for civil monetary penalties of up to $10,000 per day for 
sponsors who refuse to comply. Monetary penalties will be earmarked for 
studies that compare clinical therapies; provide authority to audit the 
completeness and accuracy of the information in the registry; and 
ensure that the Food and Drug Administration has the authority to 
correct false or misleading statements about the results of clinical 
trials.
  Later this month I will also introduce legislation to establish an 
independent office of drug safety in the Food and Drug Administration. 
Today's legislation is an important step toward reforming the FDA. I 
urge my colleagues to join me in this effort by cosponsoring this 
important legislation.
  Mr. JOHNSON. Mr. President, today I join several of my colleagues in 
introducing a very important piece of legislation that will improve 
access to information about prescription drugs for patients and their 
doctors. Today, Senators Dodd, Grassley, Wyden and I

[[Page 2981]]

are introducing the Fair Access to Clinical Trials Act or FACT Act. I 
commend my colleagues for their hard work on this legislation. I also 
thank them for their commitment to ensuring that finally, objective, 
unbiased information can be put in the hands of consumers and doctors, 
reducing negative outcomes, improving patient care, and ultimately 
reducing costs of medications.
  In recent months, we have learned that certain prescription drugs on 
the market today may not be as safe as we once thought. 
GlaxoSmithKline's antidepressant drug, Paxil, was found to increase the 
risk of suicide among adolescents. Further investigation of this issue 
indicated that some manufacturers of antidepressants highlighted 
positive findings of tests on youngsters, while playing down negative 
or inconclusive ones. In addition, the arthritis medication, Vioxx, was 
pulled off the market due to negative study findings, and over 27,000 
sudden cardiac deaths and heart attacks may have been caused by this 
medication.
  I find it unacceptable that current law does not require that the 
results of these studies on Paxil and Vioxx be made readily available 
to doctors and their patients. It is unacceptable that today, much of 
the information consumers and doctors rely on to make decisions about 
the medications they use are based on incomplete information. Patients 
are often swayed by direct-to-consumer drug advertisements and doctors 
must rely on the information they learn at drug company sponsored 
conferences. Access to complete information about prescription drugs is 
an important consumer issue, and that is why I am introducing this 
legislation that would require pharmaceutical companies to fully 
disclose clinical drug trial information in a public database before 
medications are introduced on the shelves.
  Under my legislation, all studies on medicines like Paxil and Vioxx 
would be listed in a public drug trial registry database. The database 
would include all the studies, both good and bad, the studies that are 
conducted after the drug is already on the market, and even the studies 
that are discontinued. Doctors and patients would have access to all 
different types of information so they could make a clear decision on 
which drugs are best for any circumstance.
  The drug trial database established under this legislation would be 
accessible to the public on a governmental Web site. The database will 
include information about the sponsor of the drug trial, the parameters 
of the study, and the outcome or results of the trial. Medical 
professionals ought to have complete information available when 
prescribing medications, and consumers should be aware of all the 
effects prescription drugs can have when taken over a period of time. 
Common sense tells us we need transparency in the prescription drug 
industry when it comes to the effectiveness of medications, and this 
database works towards that goal and will help to hold drug companies 
accountable for their products on the market.
  I hope the Senate and House will take up this bill and pass it. It 
addresses an important consumer right-to-know issue that will help to 
ensure that patients and doctors have the best, most accurate 
information at their fingertips when making life-altering medical 
decisions.
                                 ______
                                 
      By Mr. LEAHY:
  S. 472. A bill to criminalize Internet scams involving fraudulently 
obtaining personal information, commonly known as phishing; to the 
Committee on the Judiciary.
  Mr. LEAHY. Mr. President, today I am introducing a bill, the Anti-
Phishing Act of 2005, which targets a serious threat to the security of 
the Internet.
  Phishing is a rapidly growing class of identity theft scams on the 
Internet that is causing both short-term losses and long-term economic 
damage. In the short-term, these scams defraud individuals and 
financial institutions. Estimated losses from phishing attacks are now 
in the billions of dollars, and those losses are growing. The short-
term losses, however, are just a chapter in a larger story. In the 
long-term, phishing undermines the public's trust in the Internet. By 
making consumers uncertain about the integrity of the Internet's 
complex addressing system, phishing threatens to make us all less 
likely to use the Internet for secure transactions. If you can't trust 
where you are on the web, you are less likely to use it for commerce 
and communications.
  Those well versed in popular culture may guess that phishing was 
named after the phenomenally popular Vermont band, Phish. But phishing 
over the Internet was in fact named from the sport of fishing, as an 
analogy for its technique of luring Internet prey with convincing email 
bait. The ``F'' is replaced by a ``P-H'' in keeping with a computer 
hacker tradition.
  Phishing attacks usually start with emails that are, in Internet 
jargon, ``spoofed.'' That is, they are made to appear to be coming from 
some trusted financial institution or commercial entity. The spoofed 
email usually asks the victim to go to a website to confirm or renew 
private account information. These emails offer a link that appears to 
take the victim to the website of the trusted institution. In fact the 
link takes the victim to a phony website that is visually identical to 
that of the trusted institution, but is in fact run by the criminal. 
When the victim takes the bait and sends their account information, the 
criminal uses it--sometimes within minutes--to transfer the victim's 
funds or to make purchases. Phishers are the new con artists of 
cyberspace.
  Phishing is on the rise. The Anti-Phishing Working Group reports that 
the number of new phishing messages climbed at a monthly rate of 38 
percent in the last six months of 2004. The number of new phishing 
websites has climbed 24 percent per month since last August. And 
phishing attacks are increasingly sophisticated. Early phishing attacks 
were by novices, but there is now evidence that some attacks are backed 
by organized crime. Some of the attacks these days also include 
spyware, a type of software that is secretly installed on the victim's 
computer to surreptitiously capture account information when the victim 
visits legitimate websites.
  In addition, the Internet faces the threat of ``pharming.'' This 
insidious crime does not rely on email bait. Rather, it attacks web 
browsers and the Internet's addressing system. The effect is that even 
individuals who type a desired Internet destination into their web 
browser may be redirected to a phony web site, with the same disastrous 
result as clicking on the phony link in a phishing attack.
  Some phishers and pharmers can be prosecuted under wire fraud or 
identity theft statutes, but often these prosecutions take place only 
after someone has been defrauded. For most of these criminals, that 
leaves plenty of time to cover their tracks. It has been reported that 
the average phishing website is active on the Internet for less than 
six days. Moreover, the mere threat of these attacks undermines 
everyone's confidence in the Internet. When people cannot trust that 
websites are what they appear to be, they will not use the Internet for 
their secure transactions. Traditional wire fraud and identity theft 
statutes are not sufficient to respond to phishing and pharming.
  The Anti-Phishing Act of 2005 protects the integrity of the Internet 
in two ways. First, it criminalizes the bait. It makes it illegal to 
knowingly send out spoofed email that links to sham websites with the 
intention of committing a crime. Second, it criminalizes the sham 
websites that are the true scene of both types of crime.
  There are, of course, important First Amendment concerns to be 
protected. The Anti-Phishing Act protects parodies and political speech 
from being prosecuted as Phishing. We have worked closely with various 
public interest organizations to ensure that the Anti-Phishing Act does 
not impinge on the important democratic role that the Internet plays.
  To many Americans, phishing and pharming are new words. They are 
certainly a new form of an old crime. They are also very serious, and 
we need

[[Page 2982]]

to act aggressively to keep them from eroding the public's trust in 
online commerce and communication. I look forward to working with 
others in the Senate in addressing this growing threat to the Internet 
with effective and responsible action.
                                 ______
                                 
      By Ms. CANTWELL (for herself, Mr. Bingaman, and Mr. Lieberman):
  S. 473. A bill to amend the Public Health Service Act to promote and 
improve the allied health professions; to the Committee on Health, 
Education, Labor, and Pensions.
  Ms. CANTWELL. Mr. President, the well-being of the U.S. population 
depends to a considerable extent on having access to high quality 
health care which, in turn, requires the presence of an adequate supply 
of health care professionals. The Congress and the President recognized 
this need when we passed, and President Bush signed, the Nurse 
Reinvestment Act in the 107th Congress. Just as with nurses, we must 
also insure an adequate supply of well-prepared allied health 
professionals. That is why, today, I am introducing the Allied Health 
Reinvestment Act with my good colleagues, Senator Bingaman of New 
Mexico and Senator Lieberman of Connecticut.
  The allied health professions are many. Those recognized in the act 
include professionals in the areas of: dental hygiene, dietetics/
nutrition, emergency medical services, health information management, 
clinical laboratory sciences/medical technology, cytotechnology, 
occupational therapy, physical therapy, radiologic technology, nuclear 
medical technology, rehabilitation counseling, respiratory therapy, and 
speech-language pathology/audiology. This is not an exhaustive list, as 
the act will leave to the discretion of the Secretary of HHS additional 
professions deemed eligible.
  Today, many allied health professions are characterized by existing 
workforce shortages, declining enrollments in academic institutions, or 
a combination of both factors. The American Hospital Association, AHA, 
reports vacancy rates of 18 percent among radiology technicians, 10 
percent among laboratory technologists, 15.3 percent among imaging 
technicians, and 12.7 percent among pharmacy technicians. In addition, 
the AHA indicates that hospitals are having increasing difficulties 
recruiting these same professionals over the preceding 2-year period.
  In my own State of Washington, the Washington State Hospital 
Association reports vacancy rates of 14.3 percent among ultrasound 
technologists, 11.3 percent among radiology technicians, and 10.9 
percent among nuclear medicine technologists. These vacancy rates have 
a real effect on the hospitals in my State. When I meet with hospital 
officials back home, they always tell me how the lack of technicians 
affects patient care.
  The Bureau of Labor Statistics projected that in the period 1998-
2008, the United States would need a total of 93,000 new professionals 
in clinical laboratory science by creating 53,000 new positions and 
filling the 40,000 existing vacancies. That averages 9,000 openings per 
year for technicians, and yet academic institutions are producing only 
4,990 graduates annually. If these numbers stay constant, we will be 
short by 43,100 needed technicians in 2008.
  According to the American Hospital Association, declining enrollment 
in health education programs contributes to the critical shortages of 
health care professionals. Similarly, data from a November 2002 study 
of 90 institutions by the Association of Schools of Allied Health 
Professions, ASAHP, shows a 3-year period of decline in enrollment in 
cardiovascular perfusion technology, cytotechnology, dietetics, 
emergency medical sciences, health administration, health information 
management, medical technology, occupational therapy, rehabilitation 
counseling, respiratory therapy, and respiratory therapy technician 
programs. As an indication of a worsening situation, data from the 
2002-2003 academic year, alone, show that dental hygiene, physician 
assistant, and speech-language pathology and audiology should be added 
to this list.
  While having an adequate number of health professionals in our 
country is key to ensuring access to health care for all of us, 
certainly one of the key populations for whom a healthy supply of 
health professionals is vitally important for is our senior population.
  The U.S. Census Bureau reports that rapid growth of the population 
age 65 and over will begin in 2011 when the first of the baby boom 
generation reaches age 65 and will continue for many years. From 1900 
to 2000, the proportion of persons 65 and over tripled, going from 4.1 
percent to 12.4 percent.
  The baby-boom generation's movement into middle age, a period when 
the incidence of heart attack and stroke increases, will produce a 
higher demand for therapeutic services. Medical advances now enable 
more patients with critical problems to survive, but in order to do so 
and maintain a high quality of life, these patients may need extensive 
therapy.
  Along with the aging of the population came an increase in the number 
of Americans living with one, and often more than one, chronic 
condition. Today, it is estimated that 125 million Americans live with 
a chronic condition, and by 2020 as the population ages, that number 
will increase to an estimated 157 million, with 81 million of them 
having two or more chronic conditions. Twenty-five percent of 
individuals with chronic conditions have some type of activity 
limitations. Two-thirds of Medicare spending is for beneficiaries with 
five or more chronic conditions.
  Many individuals with chronic conditions rely on family caregivers. 
Approximately 9 million Americans provide such services, and on the 
average, they spend 24 hours a week doing so. Caregivers aged 65-74 
provide an average of 30.7 hours of care per week and individuals aged 
75 and older provide an average of 34.5 hours per week.
  Women are more likely than men to have chronic conditions, in part 
because they have longer life expectancies. These same women are 
caregivers to other chronically ill persons. In addition, 65 percent of 
caregivers are female, and of all caregivers, nearly 40 percent are 55 
years of age and older.
  Physicians report that their training does not adequately prepare 
them to care for this type of patient by providing education and 
offering effective nutritional guidance. Those aspects of care can be 
provided by allied health professionals, but many of them need better 
preparation to treat and coordinate care for patients with chronic 
conditions. While much emphasis is placed on curative forms of care, 
additional efforts must be devoted to slowing the progression of 
disease and its effects.
  One example of the effectiveness of allied health interventions may 
be illustrated by a study funded by the National Institute on Aging, 
the National Center for Medical Rehabilitation Research, and the Agency 
for Health Care Policy and Research--since renamed the Agency for 
Healthcare Research and Quality. The investigation showed that 
significant benefits resulted from a 9-month occupational therapy 
intervention intended to reduce health-related declines urban, 
multiethnic, independent-living older adults. The majority of study 
participants, 73 percent, lived alone and 26 percent reported at least 
one disability. Important health-related benefits attributable to the 
intervention continued over a 6-month interval in the absence of 
further treatment.
  The bill my colleagues and I introduce today, like the Nurse 
Reinvestment Act in the 107th Congress, is intended to provide 
incentives for individuals to seek and complete high quality allied 
health education and training. Furthermore, the bill will provide 
additional funding to ensure that such education and training can be 
provided to allied health students so that the U.S. healthcare industry 
with have a supply of allied health professionals needed to support the 
Nation's health care system in this decade and beyond.
  The bill offers allied health education, practice, and retention 
grants. Education grants will be used to expand the enrollment in 
allied health

[[Page 2983]]

education programs, especially by underrepresented racial and ethnic 
minority students, and provide educational opportunities through new 
technologies and methods, including distance-learning. Practice grants 
are intended to establish or expand allied health practice arrangements 
in noninstitutional settings to demonstrate methods that will improve 
access to primary health care in rural areas and other medically 
underserved communities. Retention grants are intended to promote 
career advancement for allied health personnel.
  Grants will also be made available to health care facilities to 
enable them to carry out demonstrations of models and best practices in 
allied health for the purpose of developing innovative strategies or 
approaches for retention of allied health professionals. These grants 
will be awarded to a variety of geographic regions, and to a range of 
different types and sizes of facilities, including facilities located 
in rural, urban, and suburban areas.
  Furthermore, this bill will give the Secretary of HHS, acting through 
the Administrator of HRSA, the authority to enter into an agreement 
with any institution that offers an eligible allied health education 
program to establish and operate a faculty loan fund to increase the 
number of qualified allied health faculty. Loans may be granted to 
faculty who are pursuing a full-time course of study or, at the 
discretion of the Secretary, a part-time course of study in an advanced 
degree program.
  I am especially proud of the provisions of this legislation regarding 
the National Health Service Corps program, the brain child of Senator 
Warren Magnuson of Washington. The NHSC program, of course, encourages 
students in the health professions such as doctors and dentists to 
serve in underserved areas throughout our nation in return for loan 
repayment assistance. And, like the NHSC program, this Allied Health 
Reinvestment Act will establish a scholarship program that provides 
scholarships to individuals seeking allied health education in exchange 
for service by those individuals in rural and other medically 
underserved areas with allied health personnel shortages.
  There are a number of organizations supporting this bill, and I thank 
them for that support. Among them, the list includes, but is not 
limited to:

     Washington State Hospital Association
     Health Work Force Institute (Seattle, WA)
     American Association for Respiratory Care
     American Association of Community Colleges
     American Clinical Laboratory Association
     American Dental Hygienists' Association
     American Dietetic Association
     American Health Information Management Association
     American Hospital Association
     American Physical Therapy Association
     American Society for Clinical Laboratory Science
     American Society for Clinical Pathology
     American Society of Radiologic Technologists
     Association of Academic Health Centers
     College of Health Deans
     Midwest Regional Deans Group
     Myositis Association
     National Association of EMS Educators
     National Cancer Registrars Association
     National Network of Health Career Programs in Two-Year 
         Colleges
     Northeast Regional Deans Group

  In addition to these organizations, I would also like to express my 
appreciation to the Association of Schools of Allied Health 
Professions, ASAHP, for its support of the legislation as well as its 
ongoing efforts to address the need for allied health professionals and 
allied health faculty.
  ASAHP, founded in 1967, has a membership that includes 108 
institutions of higher learning throughout the United States, as well 
as several hundred individual members. ASAHP publishes a quarterly 
journal and also conducts an annual survey of member institutions. This 
annual survey, called the ``Institutional Profile Survey,'' is used 
for, among other purposes, collecting student application and 
enrollment data. These data substantiate that there is a pressing need 
to address existing allied health workforce shortages, which have been 
further exacerbated by declines in enrollment that have occurred for 4 
straight years.
  In the survey conducted during the period September-November 2004 for 
the 2004-2005 class starting in fall 2004, the results from 90 academic 
institutions indicate that in 16 of the 20 professions studied, 
available classroom seats were not filled. For example, only 33 percent 
of enrollment capacity was reached for health information management 
programs in these schools. Given the emphasis on increasing the use of 
information technology in health care such as conversion to electronic 
patient records, that figure is disturbingly low.
  Similarly, the survey shows that enrollment levels were low in the 
following professions: rehabilitation counseling, 44 percent, emergency 
medical sciences, 66 percent, cytotechnology, 69 percent, and medical 
technology, 77 percent. Severe workforce shortages already exist in the 
two laboratory professions and emergency medical personnel will play a 
key role as first responders in dealing with any bioterrorism incident 
that might occur.
  Using data from the Institutional Profile Survey, as well as the 
General Accounting Office, U.S. Census Bureau, and other sources, ASAHP 
has compiled what I believe to be a compelling rationale in its support 
for the Allied Health Reinvestment Act that Senators Bingaman, 
Lieberman, and I introduce today. I ask unanimous consent that the text 
of this Rationale for an Allied Health Reinvestment Act from the 
Association of Schools of Allied Health Professions be printed in the 
Record.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

            Rationale for an Allied Health Reinvestment Act

       Led by the Association of Schools of Allied Health 
     Professions, a Washington-DC based organization with 108 
     colleges and universities as members, a coalition of 30 
     national organizations supports the enactment of an Allied 
     Health Reinvestment Act.
       The well-being of the U.S. population depends to a 
     considerable extent on having access to high quality health 
     care, which requires the presence of an adequate supply of 
     competently-prepared allied health professionals. Workforce, 
     demographic, and epidemiologic imperatives are the driving 
     forces behind the need to have such legislation enacted.


                        The Workforce Imperative

       Many allied health professions are characterized by 
     existing workforce shortages, declining enrollments in 
     academic institutions, or a combination of both factors. 
     Hospital officials have reported vacancy rates of 18 percent 
     among radiologic technologists and 10 percent among 
     laboratory technologists, plus they indicated more difficulty 
     in recruiting these same professionals than two years prior.
       Fitch, a leading global rating agency that provides the 
     world's credit markets with credit opinions, indicates that 
     labor expenses due to personnel shortages will continue to 
     plague hospitals and is the biggest financial concern for 
     that sector because it typically costs up to twice normal 
     equivalent wages to fill gaps with temporary agency help.
       The Bureau of Labor Statistics (BLS) projects that in the 
     period 1998-2008, a total of 93,000 positions in clinical 
     laboratory science need to be provided in the form of 
     creating 53,000 new jobs and filling 40,000 existing 
     vacancies. Of the 9,000 openings per year, academic 
     institutions are producing only 4,990 graduates annually. BLS 
     projections in 2004 show that nine of the 10 fastest growing 
     occupations are health or computer (information technology) 
     occupations.
       Accredited respiratory therapy programs in 2000 graduated 
     5,512 students--21% fewer than the 6,062 graduates in 1999. 
     In 2001, the number of graduates from these schools fell 
     another 20% to 4,437. The BLS expects employment of 
     respiratory therapists to increase faster than the average of 
     all occupations, increasing from 21% to 35% through 2010. The 
     aging population and an attendant rise in the incidence of 
     respiratory ailments, including asthma and COPD, and 
     cardiopulmonary diseases drive this demand.
       Employment growth in schools will result from expansion of 
     the school-age population and extended services for disabled 
     students. Therapists will be needed to help children with 
     disabilities prepare to enter special education programs.
       The American Hospital Association has identified declining 
     enrollment in health education programs as a factor leading 
     to critical shortages of health care professionals. That 
     assessment is buttressed by data from 90 institutions 
     belonging to the Association of Schools of Allied Health 
     Professions. The following professions were unable to reach 
     enrollment capacity over a

[[Page 2984]]

     three-year period: cardiovascular perfusion technology, 
     cytotechnology, dietetics, emergency medical sciences, health 
     administration, health information management, medical 
     technology, occupational therapy, rehabilitation counseling, 
     respiratory therapy, and respiratory therapy technician.
       Given the level of anxiety over the possibility of 
     terrorist attacks occurring in this country, in a study 
     released by the General Accounting Office (GAO) on April 8, 
     2003 that focused on the nation's adequacy of preparedness 
     against bioterrorism, it was reported that shortages in 
     clinical laboratory personnel exist in state and local public 
     health departments, laboratories, and hospitals. Moreover, 
     these shortages are a major concern that is difficult to 
     remedy.
       Laboratories play a critical role in the detection and 
     diagnosis of illnesses resulting from exposure to either 
     biological or chemical agents. No therapy or prophylaxis can 
     be initiated without laboratory identification and 
     confirmation of the agent in question. Laboratories need to 
     have adequate capacity and necessary staff to test clinical 
     and environmental samples in order to identify an agent 
     promptly so that proper treatment can be started and 
     infectious diseases prevented from spreading.
       Meanwhile, the U.S population continues to become more 
     racially and ethnically diverse. A health care workforce is 
     needed that better reflects the population they serve. 
     Practitioners must become more attuned to cultural 
     differences in order to facilitate communication and enhance 
     health care quality.


                       The Demographic Imperative

       The U.S. Census Bureau reports that rapid growth of the 
     population age 65 and over will begin in 2011 when the first 
     of the baby-boom generation reaches age 65 and will continue 
     for many years. The larger proportions of the population in 
     older age groups result in part from sustained low fertility 
     levels and from relatively larger declines in mortality at 
     older ages in the latter part of the 20th century. From 1900 
     to 2000, the proportion of persons 65 and over went from 4.1 
     percent to 12.4 percent.
       In the 20th century, the total population more than 
     tripled, while the 65 years and older population grew more 
     than tenfold, from 3.1 million in 1900 to 35.0 million in 
     2000.
       Among the older population, the cohort 85 years and over 
     increased from 122,000 in 1900 to 4.2 million in 2000. Since 
     1940, this age group increased at a more rapid rate than 65-
     to-74 year olds and 75-to-85 year olds in every decade. As a 
     proportion of the older population, the 85 and over group 
     went from being four percent of the older population to 12 
     percent between 1900 and 2000.


                     The Epidemiological Imperative

       The baby-boom generation's movement into middle age, a 
     period when the incidence of heart attack and stroke 
     increases, will produce a higher demand for therapeutic 
     services. Medical advances now enable more patients with 
     critical problems to survive. These patients may need 
     extensive therapy.
       According to Solucient, a major provider of information for 
     health care providers, profound demographic shifts over the 
     next twenty-five years will result in significant increases 
     in the demand for inpatient acute care services if current 
     utilization patterns do not change. An aging baby-boom 
     generation, increasing life expectancy, rising fertility 
     rates, and continued immigration will undoubtedly increase 
     the volume of inpatient hospitalizations and significantly 
     alter the mix of acute care services required by patients 
     over the next quarter century. Nationwide, demographic 
     changes alone could result in a 46 percent increase in acute 
     care bed demand by 2027. Total acute care admissions could 
     also increase by almost 13 million cases in the next quarter 
     century--a growth of 41 percent from the current number of 
     national admissions. Currently, the aged nationwide account 
     for about 40 percent of inpatient admissions and about 49 
     percent of beds. By 2027, they could make up a majority of 
     acute care services--51 percent of admissions and 59 percent 
     of beds.
       Along with the aging of the population came an increase in 
     the number of Americans living with one, and often more than 
     one, chronic condition. Today, it is estimated that 125 
     million Americans live with a chronic condition, and by 2020 
     as the population ages, that number will increase to an 
     estimated 157 million, with 81 million of them having two or 
     more chronic conditions. Twenty-five percent of individuals 
     with chronic conditions have some type of activity 
     limitations. Two-thirds of Medicare spending is for 
     beneficiaries with five or more chronic conditions.
       Many individuals with chronic conditions rely on family 
     caregivers. Approximately nine million Americans provide such 
     services, and on the average, they spend 24 hours a week 
     doing so. Caregivers age 65-74 provide an average of 30.7 
     hours of care per week and individuals age 75 and older 
     provide an average of 34.5 hours per week.
       Women are more likely than men to have chronic conditions, 
     in part because they have longer life expectancies. These 
     same women are caregivers to other chronically ill persons. 
     In addition, 65 percent of caregivers are female, and of all 
     caregivers, nearly 40 percent are 55 years of age and older.
       Physicians report that their training does not adequately 
     prepare them to care for this type of patient in areas such 
     as providing education and offering effective nutritional 
     guidance. Allied health professionals can provide those 
     aspects of care, but many of them need better preparation to 
     treat and coordinate care for patients with chronic 
     conditions. While much emphasis is placed on curative forms 
     of care, additional efforts must be devoted to slowing the 
     progression of disease and its effects.
                                  ____


                                 S. 473

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Allied Health Reinvestment 
     Act''.

     SEC. 2. FINDINGS AND PURPOSE.

       (a) Findings.--Congress makes the following findings:
       (1) The United States Census Bureau and other reports 
     highlight the increased demand for acute and chronic 
     healthcare services among both the general population and a 
     rapidly growing aging portion of the population.
       (2) The calls for reduction in medical errors, increased 
     patient safety, and quality of care have resulted in an 
     amplified call for allied health professionals to provide 
     healthcare services.
       (3) Several allied health professions are characterized by 
     workforce shortages, declining enrollments in allied health 
     education programs, or a combination of both factors, and 
     hospital officials have reported vacancy rates in positions 
     occupied by allied health professionals.
       (4) Many allied health education programs are facing 
     significant economic pressure that could force their closure 
     due to an insufficient number of students.
       (b) Purpose.--It is the purpose of this Act to provide 
     incentives for individuals to seek and complete high quality 
     allied health education and training and provide additional 
     funding to ensure that such education and training can be 
     provided to allied health students so that the United States 
     healthcare industry with have a supply of allied health 
     professionals needed to support the health care system of the 
     United States in this decade and beyond.

     SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

       Title VII of the Public Health Service Act (42 U.S.C. 292 
     et seq.) is amended by adding at the end the following:

                 ``PART G--ALLIED HEALTH PROFESSIONALS

     ``SEC. 799C. DEFINITIONS.

       ``In this part:
       ``(1) Allied health education program.--The term `allied 
     health education program' means any postsecondary educational 
     program offered by an institution accredited by an agency or 
     commission recognized by the Department of Education, or 
     leading to a State certificate or license or any other 
     educational program approved by the Secretary. Such term 
     includes colleges, universities, or schools of allied health 
     and equivalent entities that include programs leading to a 
     certificate, associate, baccalaureate, or graduate level 
     degree in an allied health profession.
       ``(2) Allied health professions.--The term `allied health 
     professions' includes professions in the following areas at 
     the certificate, associate, baccalaureate, or graduate level:
       ``(A) Dental hygiene.
       ``(B) Dietetics or nutrition.
       ``(C) Emergency medical services.
       ``(D) Health information management.
       ``(E) Clinical laboratory sciences and medical technology.
       ``(F) Cytotechnology.
       ``(G) Occupational therapy.
       ``(H) Physical therapy.
       ``(I) Radiologic technology.
       ``(J) Nuclear medical technology.
       ``(K) Rehabilitation counseling.
       ``(L) Respiratory therapy.
       ``(M) Speech-language pathology and audiology.
       ``(N) Any other profession determined appropriate by the 
     Secretary.
       ``(3) Health care facility.--The term `health care 
     facility' means an outpatient health care facility, hospital, 
     nursing home, home health care agency, hospice, federally 
     qualified health center, nurse managed health center, rural 
     health clinic, public health clinic, or any similar 
     healthcare facility or practice that employs allied health 
     professionals.

     ``SEC. 799C-1. PUBLIC SERVICE ANNOUNCEMENTS.

       ``The Secretary shall develop and issue public service 
     announcements that shall--
       ``(1) advertise and promote the allied health professions;
       ``(2) highlight the advantages and rewards of the allied 
     health professions; and
       ``(3) encourage individuals from diverse communities and 
     backgrounds to enter the allied health professions.

     ``SEC. 799C-2. STATE AND LOCAL PUBLIC SERVICE ANNOUNCEMENTS.

       ``(a) In General.--The Secretary shall award grants to 
     designated eligible entities

[[Page 2985]]

     to support State and local advertising campaigns that are 
     conducted through appropriate media outlets (as determined by 
     the Secretary) to--
       ``(1) promote the allied health professions;
       ``(2) highlight the advantages and rewards of the allied 
     health professions; and
       ``(3) encourage individuals from disadvantaged communities 
     and backgrounds to enter the allied health professions.
       ``(b) Eligible Entity.--To be eligible to receive a grant 
     under subsection (a), an entity shall--
       ``(1) be a professional, national, or State allied health 
     association, State health care provider, or association of 
     one or more health care facilities, allied health education 
     programs, or other entities that provides similar services or 
     serves a like function; and
       ``(2) prepare and submit to the Secretary an application at 
     such time, in such manner, and containing such information as 
     the Secretary may require.

     ``SEC. 799C-3. ALLIED HEALTH RECRUITMENT GRANT PROGRAM.

       ``(a) Program Authorized.--The Secretary shall award grants 
     to eligible entities to increase allied health professions 
     education opportunities.
       ``(b) Eligible Entity.--To be eligible to receive a grant 
     under subsection (a), an entity shall--
       ``(1) be a professional, national, or State allied health 
     association, State health care provider, or association of 
     one or more health care facilities, allied health education 
     programs, or other eligible entities that provides similar 
     services or serves a like function; and
       ``(2) prepare and submit to the Secretary an application at 
     such time, in such manner, and containing such information as 
     the Secretary may require.
       ``(c) Use of Funds.--An entity shall use amounts received 
     under a grant under subsection (a) to--
       ``(1) support outreach programs at elementary and secondary 
     schools that inform guidance counselors and students of 
     education opportunities regarding the allied health 
     professions;
       ``(2) carry out special projects to increase allied health 
     education opportunities for individuals who are from 
     disadvantaged backgrounds (including racial and ethnic 
     minorities that are underrepresented among the allied health 
     professions) by providing student scholarships or stipends, 
     pre-entry preparation, and retention activities;
       ``(3) provide assistance to public and nonprofit private 
     educational institutions to support remedial education 
     programs for allied health students who require assistance 
     with math, science, English, and medical terminology;
       ``(4) meet the costs of child care and transportation for 
     individuals who are taking part in an allied health education 
     program at any level; and
       ``(5) support community-based partnerships seeking to 
     recruit allied health professionals in rural communities and 
     medically underserved urban communities, and other 
     communities experiencing an allied health professions 
     shortage.

     ``SEC. 799C-4. GRANTS FOR HEALTH CAREER ACADEMIES.

       ``(a) In General.--The Secretary shall award grants to 
     eligible entities to assist such entities in collaborating to 
     carry out programs that form education pipelines to 
     facilitate the entry of students of secondary educational 
     institutions, especially underrepresented racial and ethnic 
     minorities, into careers in the allied health professions.
       ``(b) Eligible Entity.--To be eligible to receive a grant 
     under subsection (a), an entity shall--
       ``(1) be an institution that offers allied health education 
     programs, a health care facility, or a secondary educational 
     institution; and
       ``(2) prepare and submit to the Secretary an application at 
     such time, in such manner, and containing such information as 
     the Secretary may require.

     ``SEC. 799C-5. ALLIED HEALTH EDUCATION, PRACTICE, AND 
                   RETENTION GRANTS.

       ``(a) Education Priority Areas.--The Secretary may award 
     grants to or enter into contracts with eligible entities to--
       ``(1) expand the enrollment of individuals in allied health 
     education programs, especially the enrollment of 
     underrepresented racial and ethnic minority students; and
       ``(2) provide education through new technologies and 
     methods, including distance-learning methodologies.
       ``(b) Practice Priority Areas.--The Secretary may award 
     grants to or enter into contracts with eligible entities to--
       ``(1) establish or expand allied health practice 
     arrangements in noninstitutional settings to demonstrate 
     methods to improve access to primary health care in rural 
     areas and other medically underserved communities;
       ``(2) provide care for underserved populations and other 
     high-risk groups such as the elderly, individuals with HIV/
     AIDS, substance abusers, the homeless, and victims of 
     domestic violence;
       ``(3) provide managed care, information management, quality 
     improvement, and other skills needed to practice in existing 
     and emerging organized health care systems; or
       ``(4) develop generational and cultural competencies among 
     allied health professionals.
       ``(c) Retention Priority Areas.--
       ``(1) In general.--The Secretary may award grants to and 
     enter into contracts with eligible entities to enhance the 
     allied health professions workforce by initiating and 
     maintaining allied health retention programs described in 
     paragraph (2) or (3).
       ``(2) Grants for career ladder programs.--The Secretary may 
     award grants to and enter into contracts with eligible 
     entities for programs--
       ``(A) to promote career advancement for allied health 
     personnel in a variety of training settings, cross training 
     or specialty training among diverse population groups, and 
     the advancement of individuals; and
       ``(B) to assist individuals in obtaining the education and 
     training required to enter the allied health professions and 
     advance within such professions, such as by providing career 
     counseling and mentoring.
       ``(3) Enhancing patient care delivery systems.--
       ``(A) Grants.--The Secretary may award grants to eligible 
     entities to improve the retention of allied health 
     professionals and to enhance patient care that is directly 
     related to allied health activities by enhancing 
     collaboration and communication among allied health 
     professionals and other health care professionals, and by 
     promoting allied health involvement in the organizational and 
     clinical decision-making processes of a health care facility.
       ``(B) Preference.--In making awards of grants under this 
     paragraph, the Secretary shall give preferences to applicants 
     that have not previously received an award under this 
     paragraph and to applicants from rural, underserved areas.
       ``(C) Continuation of an award.--The Secretary shall make 
     continuation of any award under this paragraph beyond the 
     second year of such award contingent on the recipient of such 
     award having demonstrated to the Secretary measurable and 
     substantive improvement in allied health personnel retention 
     or patient care.
       ``(d) Eligible Entity.--To be eligible to receive a grant 
     under this section, an entity shall--
       ``(1) be a health care facility, or any partnership or 
     coalition containing a health care facility or allied health 
     education program; and
       ``(2) prepare and submit to the Secretary an application at 
     such time, in such manner, and containing such information as 
     the Secretary may require.

     ``SEC. 799C-6. DEVELOPING MODELS AND BEST PRACTICES PROGRAM.

       ``(a) Authorized.--The Secretary shall award grants to 
     eligible entities to enable such entities to carry out 
     demonstration programs using models and best practices in 
     allied health for the purpose of developing innovative 
     strategies or approaches for the retention of allied health 
     professionals.
       ``(b) Eligible Entity.--To be eligible to receive a grant 
     under this section, an entity shall--
       ``(1) be a health care facility, or any partnership or 
     coalition containing a health care facility or allied health 
     education program; and
       ``(2) prepare and submit to the Secretary an application at 
     such time, in such manner, and containing such information as 
     the Secretary may require.
       ``(c) Distribution of Grants.--In awarding grants under 
     this section, the Secretary shall ensure that grantee 
     represent a variety of geographic regions and a range of 
     different types and sizes of facilities, including facilities 
     located in rural, urban, and suburban areas.
       ``(d) Use of Funds.--An entity shall use amounts received 
     under a grant under this section to carry out demonstration 
     programs of models and best practices in allied health for 
     the purpose of--
       ``(1) promoting retention and satisfaction of allied health 
     professionals;
       ``(2) promoting opportunities for allied health 
     professionals to pursue education, career advancement, and 
     organizational recognition; and
       ``(3) developing continuing education programs that 
     instruct allied health professionals in how to use emerging 
     medical technologies and how to address current and future 
     health care needs.
       ``(e) Area Health Education Centers.--The Secretary shall 
     award grants to area health education centers to enable such 
     centers to enter into contracts with allied health education 
     programs to expand the operation of area health education 
     centers to work in communities to develop models of 
     excellence for allied health professionals or to expand any 
     junior and senior high school mentoring programs to include 
     an allied health professions mentoring program.

     ``SEC. 799C-7. ALLIED HEALTH FACULTY LOAN PROGRAM.

       ``(a) Establishment.--The Secretary, acting through the 
     Administrator of the Health Resources and Services 
     Administration, may enter into an agreement with any 
     institution offering an eligible allied health education 
     program for the establishment and operation

[[Page 2986]]

     of a faculty loan fund in accordance with this section 
     (referred to in this section as the `loan fund'), to increase 
     the number of qualified allied health faculty.
       ``(b) Agreements.--Each agreement entered into under this 
     section shall--
       ``(1) provide for the establishment of a loan fund by the 
     institution offering the allied health education program 
     involved;
       ``(2) provide for deposit in the loan fund of--
       ``(A) the Federal capital contributions to the fund;
       ``(B) an amount provided by the institution involved which 
     shall be equal to not less than one-ninth of the amount of 
     the Federal capital contribution under subparagraph (A);
       ``(C) any collections of principal and interest on loans 
     made from the fund; and
       ``(D) any other earnings of the fund;
       ``(3) provide that the loan fund will be used only for the 
     provision of loans to faculty of the allied health education 
     program in accordance with subsection (c) and for the costs 
     of the collection of such loans and the interest thereon;
       ``(4) provide that loans may be made from such fund only to 
     faculty who are pursuing a full-time course of study or, at 
     the discretion of the Secretary, a part-time course of study 
     in an advanced degree program; and
       ``(5) contain such other provisions determined appropriate 
     by the Secretary to protect the financial interests of the 
     United States.
       ``(c) Loan Provisions.--Loans from any faculty loan fund 
     established pursuant to an agreement under this section shall 
     be made to an individual on such terms and conditions as the 
     allied health education program may determine, except that--
       ``(1) such terms and conditions are subject to any 
     conditions, limitations, and requirements prescribed by the 
     Secretary;
       ``(2) in the case of any individual, the total of the loans 
     for any academic year made by an allied health education 
     program from loan funds established pursuant to agreements 
     under this section may not exceed $30,000, plus any amount 
     determined by the Secretary on an annual basis to reflect 
     inflation;
       ``(3) upon completion by the individual of each of the 
     first, second, and third year of full-time employment, as 
     required under the loan agreement, as a faculty member in an 
     allied health education program, the program shall cancel 20 
     percent of the principal and interest due on the amount of 
     the unpaid portion of the loan on the first day of such 
     employment;
       ``(4) upon completion by the individual of the fourth year 
     of full-time employment, as required under the loan 
     agreement, as a faculty member in an allied health education 
     program, the program shall cancel 25 percent of the principal 
     and interest due on the amount of the unpaid portion of the 
     loan on the first day of such employment;
       ``(5) the loan may be used to pay the cost of tuition, 
     fees, books, laboratory expenses, and other reasonable 
     education expenses;
       ``(6) the loan shall be repayable in equal or graduated 
     periodic installments (with the right of the borrower to 
     accelerate repayment) over the 10-year period that begins 9 
     months after the individual ceases to pursue a course of 
     study in an allied health education program; and
       ``(7) such loan shall--
       ``(A) beginning on the date that is 3 months after the 
     individual ceases to pursue a course of study in an allied 
     health education program, bear interest on the unpaid balance 
     of the loan at the rate of 3 percent per year; or
       ``(B) subject to subsection (e), if the allied health 
     education program determines that the individual will not 
     complete such course of study or serve as a faculty member as 
     required under the loan agreement under this subsection, bear 
     interest on the unpaid balance of the loan at the prevailing 
     market rate.
       ``(d) Payment of Proportionate Share.--Where all or any 
     part of a loan (including interest thereon) is canceled under 
     this section, the Secretary shall pay to the allied health 
     education program involved an amount equal to the program's 
     proportionate share of the canceled portion, as determined by 
     the Secretary.
       ``(e) Review by Secretary.--At the request of the 
     individual involved, the Secretary may review any 
     determination by an allied health education program under 
     this section.

     ``SEC. 799C-8. SCHOLARSHIP PROGRAM FOR SERVICE IN RURAL AND 
                   OTHER MEDICALLY UNDERSERVED AREAS.

       ``(a) Program Authorized.--The Secretary shall establish a 
     scholarship program (referred to in this section as the 
     `program') to provide scholarships to individuals seeking 
     allied health education who agree to provide service in rural 
     and other medically underserved areas with allied health 
     personnel shortages.
       ``(b) Preference.--In awarding scholarships under this 
     section, the Secretary shall give preference to--
       ``(1) applicants who demonstrate the greatest financial 
     need;
       ``(2) applicants who agree to serve in health care 
     facilities experiencing allied health shortages in rural and 
     other medically underserved areas;
       ``(3) applicants who are currently working in a health care 
     facility who agree to serve the period of obligated service 
     at such facility;
       ``(4) minority applicants; and
       ``(5) applicants with an interest in a practice area of 
     allied health that has unmet needs.
       ``(c) Program Requirements.--
       ``(1) Contracts.--Under the program, the Secretary shall 
     enter into contracts with eligible individuals under which 
     such individuals agree to serve as allied health 
     professionals for a period of not less than 2 years at a 
     health care facility with a critical shortage of allied 
     health professionals in consideration of the Federal 
     Government agreeing to provide to the individuals 
     scholarships for attendance in an allied health education 
     program.
       ``(2) Eligible individuals.--In this subsection, the term 
     `eligible individual' means an individual who is enrolled or 
     accepted for enrollment as a full-time or part-time student 
     in an allied health education program.
       ``(3) Service requirement.--
       ``(A) In general.--The Secretary may not enter into a 
     contract with an eligible individual under this section 
     unless the individual agrees to serve as an allied health 
     professional at a health care facility with a critical 
     shortage of allied health professionals for a period of full-
     time service of not less than 2 years, or for a period of 
     part-time service in accordance with subparagraph (B).
       ``(B) Part-time service.--An individual may complete the 
     period of service described in subparagraph (A) on a part-
     time basis if the individual has a written agreement that--
       ``(i) is entered into by the facility and the individual 
     and is approved by the Secretary; and
       ``(ii) provides that the period of obligated service will 
     be extended so that the aggregate amount of service performed 
     will equal the amount of service that would be performed 
     through a period of full-time service of not less than 2 
     years.
       ``(d) Reports.--Not later than 18 months after the date of 
     enactment of this part, and annually thereafter, the 
     Secretary shall prepare and submit to the appropriate 
     committees of Congress a report describing the program 
     carried out under this section, including statements 
     regarding--
       ``(1) the number of enrollees by specialty or discipline, 
     scholarships, and grant recipients;
       ``(2) the number of graduates;
       ``(3) the amount of scholarship payments made;
       ``(4) which educational institution the recipients 
     attended;
       ``(5) the number and placement location of the scholarship 
     recipients at health care facilities with a critical shortage 
     of allied health professionals;
       ``(6) the default rate and actions required;
       ``(7) the amount of outstanding default funds of the 
     scholarship program;
       ``(8) to the extent that it can be determined, the reason 
     for the default;
       ``(9) the demographics of the individuals participating in 
     the scholarship program; and
       ``(10) an evaluation of the overall costs and benefits of 
     the program.

     ``SEC. 799C-9. GRANTS FOR CLINICAL EDUCATION, INTERNSHIP, AND 
                   RESIDENCY PROGRAMS.

       ``(a) Program Authorized.--The Secretary shall award grants 
     to eligible entities to develop clinical education, 
     internship, and residency programs that encourage mentoring 
     and the development of specialties.
       ``(b) Eligible Entities.--To be eligible for a grant under 
     this section an entity shall--
       ``(1) be a partnership of an allied health education 
     program and a health care facility; and
       ``(2) prepare and submit to the Secretary an application at 
     such time, in such manner, and containing such information as 
     the Secretary may require.
       ``(c) Use of Funds.--An eligible entity shall use amounts 
     received under a grant under this section to--
       ``(1) develop clinical education, internship, and residency 
     programs and curriculum and training programs for graduates 
     of an allied health education program;
       ``(2) provide support for faculty and mentors; and
       ``(3) provide support for allied health professionals 
     participating in clinical education, internship, and 
     residency programs on both a full-time and part-time basis.

     ``SEC. 799C-10. GRANTS FOR PARTNERSHIPS.

       ``(a) In General.--The Secretary shall award grants to 
     eligible entities to enable such entities to form 
     partnerships to carry out the activities described in this 
     section.
       ``(b) Eligible Entity.--To be eligible to receive a grant 
     under this section, and entity shall--
       ``(1) be a partnership between an allied health education 
     program and a health care facility; and
       ``(2) prepare and submit to the Secretary an application at 
     such time, in such manner, and containing such information as 
     the Secretary may require.

[[Page 2987]]

       ``(c) Use of Funds.--An eligible entity shall use amounts 
     received under a grant under this section to--
       ``(1) provide employees of the health care facility that is 
     a member of the partnership involved advanced training and 
     education in a allied health education program;
       ``(2) establish or expand allied health practice 
     arrangements in non-institutional settings to demonstrate 
     methods to improve access to health care in rural and other 
     medically underserved communities;
       ``(3) purchase distance learning technology to extend 
     general education and training programs to rural areas, and 
     to extend specialty education and training programs to all 
     areas; and
       ``(4) establish or expand mentoring, clinical education, 
     and internship programs for training in specialty care areas.

     ``SEC. 799C-11. ALLIED HEALTH PROFESSIONS TRAINING FOR 
                   DIVERSITY.

       ``The Secretary, acting in conjunction with allied health 
     professional associations, shall develop a system for 
     collecting and analyzing allied health workforce data 
     gathered by the Bureau of Labor Statistics, the Health 
     Resources and Services Administration, other entities within 
     the Department of Health and Human Services, the Department 
     of Veterans Affairs, the Center for Medicare & Medicaid 
     Services, the Department of Defense, allied health 
     professional associations, and regional centers for health 
     workforce studies to determine educational pipeline and 
     practitioner shortages, and project future needs for such a 
     workforce.

     ``SEC. 799C-12. ALLIED HEALTH PROFESSIONS TRAINING FOR 
                   DIVERSITY.

       ``The Secretary shall include schools of allied health 
     among the health professions schools that are eligible to 
     receive grants under this part for the purpose of assisting 
     such schools in supporting Centers of Excellence in health 
     professions education for under-represented minority 
     individuals.

     ``SEC. 799C-13. REPORTS BY GENERAL ACCOUNTING OFFICE.

       ``Not later than 4 years after the date of enactment of 
     this part, the Comptroller General of the United States shall 
     conduct an evaluation of whether the programs carried out 
     under this part have demonstrably increased the number of 
     applicants to allied health education programs and prepare 
     and submit to the appropriate committees of Congress a report 
     concerning the results of such evaluation.

     ``SEC. 799C-14. AUTHORIZATION OF APPROPRIATIONS.

       ``There is authorized to be appropriated to carry out this 
     part, such sums as may be necessary for each of fiscal years 
     2006 through 2011.''.

                          ____________________