[Congressional Record Volume 151, Number 20 (Monday, February 28, 2005)]
[Senate]
[Pages S1796-S1810]
From the Congressional Record Online through the 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'
[[Page S1797]]
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 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.
[[Page S1798]]
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 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''.
[[Page S1799]]
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
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
[[Page S1800]]
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--
``(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
[[Page S1801]]
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, 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
[[Page S1802]]
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.
``(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
[[Page S1803]]
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) 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
[[Page S1804]]
patients and their doctors. Today, Senators Dodd, Grassley, Wyden and I
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 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.
[[Page S1805]]
______
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 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
[[Page S1806]]
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 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
[[Page S1807]]
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 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
[[Page S1808]]
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 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
[[Page S1809]]
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.
``(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.
[[Page S1810]]
``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.''.
____________________