Senate Committee Completes Ag Approps Bill
On June 27, the Senate Appropriations Committee approved
H.R.2744, making appropriations for FY2006 for Agriculture, Rural Development,
Food & Drug Administration (FDA) and Related Agencies. The legislation
emerged from Committee with no controversy, but is not expected to
be hassle-free when considered by the full Senate.
For FDA, the committee recommends a total of $1,866,772,000
(almost $4 million more than the House-passed total), with $305 million
to
be raised from prescription drug user fees (PDUFA), $11.3 million from
animal drug fees, and $40.3 million from medical device fees.
Issues raised in the committee report include:
“Follow-on Biologics” – FDA is asked to report 90
days post-enactment on the “status of its activities” related
to developing “an approval and post-approval monitoring system” for
follow-ons.
Drug Safety – FDA is commended for
its Critical Path work. The Report also mentions the work of the C-Path
Institute at University
of Arizona, headed by Dr. Ray Woosley, formerly with Georgetown University
and “father” of the concept of the AHRQ-funded Centers
for Education & Research on Therapeutics (CERTS). The bill provides
$750,000 to fund collaborative work between C-Path and the University
of Utah on cardiovascular biomarkers to predict safety and clinical
outcome.
In providing $5 million for drug safety, the Committee expressed concern
about FDA’s efforts to enhance the CDER Office of Drug Safety
and requests a report on this in 90 days. Particular mention is made
of efforts related to orphan products.
Drug Counterfeiting/Track & Trace – The
committee directed FDA to report in 90 days regarding its experience
and findings in working
with manufacturers on their use of authentication technologies and
encourages the agency to issue draft guidance for use of such technologies.
Authorized Generics – The committee
expressed concern that increasing numbers of “authorized generics” could
adversely affect market entry for generic products and urges FDA to
ensure incentives
for generics are preserved.
Prescription Drug Compounding – $750,000 is provided for a pilot
program with FDA and United States Pharmacopeia (USP) to speed up developing
monographs for compounded medications, in consultation with compounding
pharmacists.
Monographs for Unapproved Drugs – The
committee asks for an FDA report in 90 days, regarding how the agency
will regulate, in a “uniform
and transparent” way, drugs on the market for
a long time but have not been FDA-approved. Last year, FDA was asked
to provide a report on the feasibility of a monograph system for these
products; the report states FDA had said such a system “would
be scientifically infeasible and cost prohibitive.”
Orphan Diseases – The committee urges
FDA to work with its advisory committee members to assist with clinical
trial design for orphan products,
and to allow those experts who participated in clinical trial design
also to participate in product review. In addition, the report expresses
support for the Independent Consultants for Biotechnology Clinical
Protocols, about which FDA issued a guidance document in May 2003.
BIO strongly supported this new program in PDUFA III re-authorization.
Finally, the committee “encourages enhanced exploration of potential
surrogate endpoints and use of FDAMA’s fast-track provision” to
provide patient access as soon as possible in cases of serious and
life-threatening illness.
Food – Several comments are made regarding
efforts to address food-borne illness and seafood safety. In addition,
the committee expressed
concern that food labels may be misleading with respect to health claims,
nutrient content, and calories; asked FDA to ensure the accuracy of
the Nutrition Facts panel, and asked for a report by Feb. 1, 2006
on the kinds of violations FDA is seeing on food labels and the actions
being taken about this.
Dietary Supplements – FDA is asked
to produce, in 90 days, a cost estimate for establishing a system for
mandatory reporting of
adverse events for dietary supplements. Of the $5.56 million provided
for the adverse events reporting system at CFSAN (CAERS), $1.7 million
is allocated specifically for supplements. The committee expressed
concern about FDA’s failure to publish the Good Manufacturing
Practices rule for supplements, and asked this be done, along
with directing the agency to prioritize its funds so it can enhance
its
efforts to enforce the Dietary Supplement Health & Education Act
(DSHEA). Finally, an additional $500,000 is provided for a review of
botanicals in supplement products, currently under way with the National
Center for Natural Products in Mississippi.
Animal Welfare Act – The Animal and
Plant Health Inspection Service (APHIS) Animal Care Unit recieved
$17,478,000 for the enforcement of the Animal Welfare Act.
This is
the same amount requested in the President's budget
and the same amount provided in the House-passed bill. The FY 2006
funding would be a 6% increase over last year's funding of $16,485,000.
The prognosis for this bill being considered by the
full Senate is not clear. Several FDA-related issues not considered
during subcommittee
or full committee mark-up can be expected to be raised on the floor.
These include provisions related to avoiding conflict of interest on
FDA advisory committees and legalizing prescription drug importation.
Sen. Byron Dorgan (D-ND) stated unequivocally he will bring an importation
provision to the Senate for a vote, in the context of this or other
bills.
Return to top
EPA’s Proposed Human Pesticide
Testing Analysis Released
On June 28, Reps. Henry Waxman (D-CA) and Hilda Solis
(D-CA) and Sen. Barbara Boxer (D-CA) released a report, prepared by
Democratic staff
of the House Government Reform Committee. The report presents an analysis
of the potential impacts of a proposal currently in draft at the Environmental
Protection Agency (EPA), according to the report, “will
allow the systematic testing of pesticides on humans.”
The report says pesticide manufacturers have importuned
the Administration to allow such testing, effectively reversing a moratorium
on human pesticide testing put in place in 1998 by then-EPA Administrator
Carol Browner.
According to the report, in addition to the fact EPA
currently is reviewing results from a number of human studies that
are ethically
flawed, the draft proposed rule would essentially institutionalize
such studies, which should be prohibited altogether. The report’s
analysis of the draft proposal indicates if studies were done
according to the proposal, they would not meet minimal human testing
requirements
set out in a recent National Academy of Sciences report. The report
says the rule would not “establish national review panel to
prevent abusive experiments, fails to provide full protections for
children and other vulnerable population, and includes multiple loopholes
that undermine its effectiveness.”
Under a bill approved by the Senate this week, EPA would be prohibited
for one year from allowing pesticides to be tested on human volunteers
or to use data from such testing. Part
of the EPA appropriations bill, the amendment by Sen. Barbara Boxer
(D-CA) is necessary to protect
children and pregnant women from exposure to chemicals without proper
controls. Boxer called it a “time out” to consider ethical,
moral and health issues. Industry said the ban was too broad.
A related amendment, calling for EPA to publish its review and rules
on human testing, also passed the Senate. The Boxer action would restore
a ban put in place during the Clinton Administration and in force during
President Bush’s first term. The House approved similar legislation
last month.
Return to top
CMS Announces CAP for Medicare Part B Drugs
On June 27, the Centers for Medicare & Medicaid Services
(CMS) announced its interim final rule on the new Competitive Acquisition
Program (CAP)
program will be published in the Federal Register on July 6. This program
was mandated as part of the Medicare Part B payment/reimbursement reforms
of the Medicare Modernization Act (MMA). It offers physicians an optional
way to obtain Part B covered drugs through distributors/vendors that
will be selected by CMS on a competitive basis.
In announcing the rule, CMS Administrator Dr. Mark
McClellan referred to the value of this kind of program in reducing
administrative
and
logistical burdens on physicians. In addition, supporters of the program
argue there could be cost savings for patients over the long term and
financial advantages for physicians, who otherwise bill Medicare directly
for the drugs they administer, at ASP + 6%, be paid 80%, and bill the
patient the remaining 20% (doctors receive a separate reimbursement
for administrative and other costs associated with providing the drug
to the patient).
Under the CAP program, physicians would obtain the products from a
CMS-authorized vendor (at a previously negotiated price), who then
would bill Medicare for the ASP + 6% and bill the patient for any applicable
deductible or co-payment. The physician would continue to be reimbursed
by Medicare for administration costs.
CMS will accept bids from potential CAP vendors July
6 - Aug. 5. Comments on the interim final rule are due by Sept.
6,
and the program will go into effect Jan. 1, 2006. The CAP program
is not mandatory, so physicians can choose whether to obtain products
this way or purchase them as they currently do. An annual opportunity
will exist for physicians to decide which option to choose, with the
first opportunity being October 1.
A physician will select a single vendor from a list of approved vendors
and purchase all products from this vendor. Vendor selection will be
based on criteria including the price of the products and various financial
stability, quality, and integrity requirements. The vendor will need
to be able to supply all covered drugs (181 drugs will be included
in the program, of the 440 currently billed through “incident
to physician services” provisions) and will need to service physicians
nationally.
Among concerns raised about the program are questions of how CMS will
ensure that all of the vendors’ drugs are pure, potent, of high
quality, and authentic.
Return to top
Obesity Bills Introduced in Senate
On June 28, Sen. Bill Frist (R-TN), with several bipartisan
cosponsors, introduced two bills designed to address what he called
the “fast-growing
problem” of obesity.
S. 1324, the “Childhood Obesity Reduction Act,” cosponsored
by Sen. Ron Wyden (D-OR), would establish the following:
• Congressional Council on Childhood Obesity to work with outside
experts on a program to educate, inform, and coordinate activities
related to reducing obesity among children; and
• Nonprofit National Foundation for the Prevention
& Reduction of Childhood Obesity. The foundation would evaluate and
disseminate information
about model plans used by schools to reduce obesity, make “challenge
awards” to schools, and participate in various meetings, workshops,
etc. A non-profit entity would receive grants for HHS to incorporate
and start the foundation, which thereafter would receive additional
annual grants (up to $2.2 million per year beginning in 2009).
S. 1325, the “Improved Nutrition and Physical
Activity Act of 2005 (IMPACT),” cosponsored by Sen. Jeff Bingaman
(D-NM) and others, has been introduced before, but never acted on.
Among other
things, it would do the following:
• add obesity and related issues to the list of priority health matters
under the Health Professions training programs of Title VII of the
Public Health Service Act and authorize funds for health professions
training in the prevention, diagnosis, and treatment of obesity;
• authorize funds for a demonstration program with community organizations
working with schools and other parts of the community to implement
beneficial approaches to reducing obesity;
• authorize the Centers for Disease Control
(CDC) specifically to collect data about children’s
fitness;
• require AHRQ to review information and report on obesity trends
in sub-populations;
• authorize the use of funds for Preventive Services Block Grants
to states for community education on nutrition and physical activity;
• require the HHS Secretary to report on obesity and fitness-related
research across HHS; and
• require a report on the effectiveness of the Youth Media Campaign
in changing behavior and reducing obesity.
Both bills have been referred to the Senate Committee on Health, Education,
Labor, & Pensions (HELP). There has been no indication to date
on when the Committee plans to consider them.
Return to top
Waxman, Markey Re-Introduce Clinical Trials Bill
On June 30, Reps. Henry Waxman (D-CA), Ed Markey (D-MA), and 30 others
introduced H.R. 3196, the Fair Access to Clinical Trials (FACT) Act.
The bill would require the Secretary of HHS to maintain a database
of clinical trials information, including both pre- and post-market
studies of drugs, biological products, and medical devices.
In a press statement on the bill’s introduction,
Markey said, “Drug
companies should not be able to pick and choose which trials they want
to disclose and which they want to keep from the public. The medical
community deserves to have a complete picture of the safety and effectiveness
of drugs and devices.”
The bill’s requirements would expand current activities (clinicaltrials.gov).
Currently, requirements to register clinical trials apply to studies
related to serious and life-threatening illnesses; H.R. 3196 would
include all clinical trials. The bill distinguishes between trials
to test safety and effectiveness, which must be listed, and trials
testing safety only (or feasibility, in the case of devices) or that
investigate pharmacokinetics. Those trials would be excluded, except
for pharmacokinetic studies in special populations. The bill also indicates
classified information, as defined in title 5, U.S.C., would be
excluded.
Under the bill, before beginning a clinical study
sponsors would be required to list information including the purpose
and hypothesis
of the study, the medical condition being studied, the intervention,
the outcome being sought, the ethics review of the study, expected
start and ending dates, eligibility criteria for enrolling, identification
of a product being studied as either FDA-approved or not, contact information
for scientific inquiries, and any restrictions the study sponsor places
on investigators as regards their ability to present or publish their
findings. Sponsors would be required to update the information in the
database at lease once each six months, highlighting any changes and
stating when and why such changes were made.
Additional requirements would apply for trials relating
to serious and life-threatening conditions, including a brief summary
of the
study in lay language; location of trial sites and points of contact,
enrollment status, and any additional information that might be available
under a treatment IND.
Results of all clinical trials also would be posted, under the provisions
of H.R. 3196, and must be provided by the sponsor in a “structured
abstract … in a form not likely to mislead or distort the results.” The
results information would include the actual completion date and an
explanation if this date differs from the earlier-listed expected date;
primary and secondary outcomes; number and kinds of significant adverse
events, whether or not determined to be caused by the intervention;
citations to any published articles about the study; status of FDA
review, if any, or an explanation of why the data haven’t been
submitted to FDA; drop-out rate and reasons; demographics of study
population; and agreements, if any, to restrict presentation or publication
of results.
The bill would require results to be submitted within one year of
the estimated or actual study completion date, whichever is earlier,
unless the Secretary grants an exception or unless an article about
the study results is pending publication. If an article has been submitted
for publication, there could be an extension of the time. In the case
of a study that lasts longer than three years, interim reports would
be required, at the three year anniversary and annually thereafter.
The Secretary could waive the results submission requirements in “extraordinary
circumstances.”
Failure to comply with the requirements of the legislation could result
in civil monetary penalties; ineligibility for federal grants, contracts,
or cooperative agreements; or ineligibility for either INDs or IDEs.
In the case of results not being submitted, the Secretary would be
authorized to release information about the study and study results,
notwithstanding current prohibitions in law against such public release.
By definition, the bill clarifies that no information would be made
public through the database that would violate personal privacy or
reveal a trade secret.
The legislation would require a change in regulations regarding the
functions of IRBs, to add that IRBs would be required to determine
if these requirements are being met and to deny approval for studies
that are not properly registered with the database.
There has been no indication to date that the Energy & Commerce
Committee, to which the bill is referred, plans action on this issue
or on legislation. In the meantime, however, the major trade associations
representing the drug and biotechnology industries have indicated their
belief that all clinical trials should be registered with clinicaltrials.gov and that clinically meaningful results should be posted in a database
accessible to the public. Several privately sponsored, publicly accessible
databases have been established, both by individual companies and by
the Pharmaceutical Research and Manufacturers of America (PhRMA), to
which trial results are being posted.
Return to top
USDA Confirms First U.S.-Born Case of BSE Found in Waco,
TX
The first U.S. case of BSE in a native-born animal
was confirmed this week after further testing at a World Animal Health
Organization (OIE)
lab in Weybridge, England. The 12-year-old Brahman cross-breed animal
was tested originally in November 2004 when it arrived at 3/D-4/D
plant that serves the pet food industry.
USDA, FDA and industry all have said essentially
the same thing: the federal and industry firewalls designed to mitigate
BSE in the U.S.
worked. The animal was identified and destroyed, and the food/feed
supply was unaffected.
“The source herd is now under a hold order as we identify animals
of interest within the herd,” said USDA Chief Veterinarian Dr.
John Clifford. “Consistent with (international animal health)
guidelines, animals of interest include any other animals that were
born the same year as this animal, as well as any born the year before
and the year after…we are also interested in any of this animal’s
offspring that were born within the last two years.”
The animal was nonambulatory and following initial
testing, its body was incinerated so that no part of
the animal entered
the food, feed or pet food chains, USDA said this week. Since the animal
was born four years before the 1997 FDA feed ban was implemented, the
source of infection is under investigation. FDA is reviewing the feed
records from the ranch where the animal was born and the processing
records of local feed plants to check for FDA feed ban compliance since
1997. USDA has not released the name or location of the ranch where
the animal lived.
The pet food company involved, Champion Pet Foods, issued a June 29
statement that said, in part: “Last year, Champion Pet Foods
began testing all dead and non-ambulatory cattle for BSE as part of
USDA’s testing program. These cattle are brought to our company…from
all over the region…On Monday, Nov. 15, 2004, a cow was brought
to us from an outside source as is every cow that enters this facility.
We do not know the origin of this cow. The cow was dead on arrival…we
followed our normal daily procedures and sent a sample from this cow
to the USDA-approved laboratory at Texas A&M. They then tested
it and the results proved inconclusive…A USDA representative
took the entire carcass in question to Texas Veterinary Diagnostic
Laboratory at Texas A&M where it was incinerated. Following USDA
procedures, no part of the cow entered the pet food chain.”
So far only Taiwan and Indonesia have announced they’ve
reintroduced their import bans on U.S. beef. The Australian beef industry,
which
has seen Asian beef sales skyrocket since the first U.S. case of BSE
was found in 2003, backed its U.S. counterparts, urging Japanese consumers
to not turn away from beef based on the U.S. announcement, stressing
the U.S. case was “isolated and the animal did not enter the
food chain.” Japanese Prime Minister Junichiro Koizumi
told reporters June 30 he saw no impact of the U.S. announcement on
his
government’s decision to reopen beef trade with the U.S. Japan
has had 20 cases of native-born BSE.
No U.S. state has said it will stop taking live animals
from Texas, a move, Clifford said, that “wouldn’t make
any sense with the safeguards we have in place.” U.S. futures
markets and cattle sales have been relatively unfazed by the USDA announcement.
A consumer tracking survey conducted this week by
the National Cattlemen’s
Beef Assn. found USDA’s announcement didn’t affect consumer
confidence that U.S. beef is safe from BSE. The independent telephone
survey of 927 adults found 92% of American consumers are confident
U.S. beef is safe from mad cow disease. The level of confidence in
U.S. beef safety has remained strong (average 91%) since the first
U.S. case (in an imported Canadian dairy cow) was announced in December
2003.
Return to top Detailed Traceback System Discussed
USDA used DNA analysis to trace the second case of
U.S. BSE to its birth herd after ear tags inadvertently were confused
with those of
other animals rendered at the pet food plant in Waco, TX. This development
has rekindled talk of quickly implementing a more sophisticated animal
identification system in the U.S.
Rep. Bob Goodlatte (R-VA), chair of the House Agriculture
Committee, said a system to trace cattle movement needs to be operational “as
soon as possible.” USDA has said its mandatory system should
be in place by January 2009, but Goodlatte ventured the industry can
move more quickly than the government. NCBA said it’s developing
its own tracking system that will be fully operational by October
2006, with testing beginning Oct. 1, 2005.
Return to top Senate Passes CAFTA After Sugar Deal Fails
The deals cut to protect the sugar industry from the fear of soaring
imports failed to hit the mark for the sugar industry, but apparently
the deal was sweet enough to move enough Senators to vote to approve
the Central America Free Trade Agreement (CAFTA) 54-45. The vote was
the closest of any recently approved trade pact.
The American Sugar Alliance dismissed the Bush Administration’s
offer to pay CAFTA countries in cash or commodities, or convert imported
sugar into ethanol so sugar imports don’t exceed the 1.523-million-ton
annual cap. U.S. Trade Representative Rob Portman, however, said the
assurances from Secretary of Agriculture Mike Johanns were as far
as the Administration would go “so I don’t think there
will be a need to make any other substantive changes.”
In the Senate, the USDA deal was strong enough to move Sen. Saxby
Chambliss (R-GA), chair of the Senate Agriculture Committee and a sugar
supporter, to switch his vote in favor of CAFTA approval.
The White House turned full attention to the House,
hammering home the Johanns agreement on sugar protection and targeting
House members
who were invited by the Bush Administration to participate in the development
of the USDA assurances. The House Ways & Means Committee this week
approved the trade pact, setting up a July floor vote.
House opposition to CAFTA is not just about sugar. A considerable
number of members are concerned about labor protections, and several
members want the White House to assure them that labor violations will
receive the same status as trade violations in the treaty dispute resolution
process.
Return to top Senate Passes Energy Bill, Conference Battles Loom
With relatively little pain, the Senate this week approved a comprehensive
energy bill, setting up a series of conference battles with the House
bill approved last month. At issue will be several controversial items
that stymied enactment in the last Congress, including oil exploration
in the Alaskan National Wildlife Reserve, liability protection for
MTBE makers, and the level of tax incentives for various energy-related
endeavors.
One sure-fire sticking point will be how much ethanol and biodiesel
oil refiners will be required to mix in their gasoline and diesel fuel
to meet the requirements of the Renewable Fuels Standard (RFS). The
Senate bill calls for 8 billion gallons to be used by 2012, while the
House bill sets the cap at 5 billion gallons. Reps. Gil Gutknecht (R-MN)
and Stephanie Herseth (D-SD) introduced legislation in the House this
week setting the ceiling on RFS alternative fuels blending at 8 billion
gallons, a move designed to push House conferees closer to the Senate
number.
Conferees will be named after Congress returns from its July 4 recess.
Return to top COOL Moving To Top of List for Ag Legislators
While ag groups across Washington generally praised the introduction
of legislation to allow for voluntary country-of-origin labeling (COOL),
Senate champions continued their push to keep the system mandatory.
Sen. Tim Johnson (D-SD) introduced legislation to
move the implementation date for mandatory COOL to January 30, 2006.
Johnson’s bill would
cover all commodities, including muscle cuts of beef, veal, lamb
and pork; ground beef, ground lamb and ground pork; farm-raised fish
and shellfish; perishable ag commodities and peanuts.
Meanwhile Sens. John Cornyn (R-TX) and Blanche Lincoln (D-AR) introduced
a bill that would make COOL voluntary for meat. The bill is a companion
to HR 2068 in the House.
Return to top
New Bills
A number of new bills have been introduced. Click
here to send a request for a copy of the text or more information about
the bill.
S.1324
Sen. Bill Frist (R-TN) introduced the “Childhood Obesity Reduction
Act.”
S.1325
Frist also proposed the “Improved Nutrition and Physical Activity
Act of 2005 (IMPACT).”
S.1331
Legislation offered by Sen. Tim Johnson (R-SD) would change the date
of implementation of country of origin labeling to January 30, 2006.
S.1333
A bill proposed by Sen. John Cornyn (R-TX) would establish a voluntary
program for country of origin labeling of meat.
S.1337
Sen. Mike Enzi (R-WY) introduced a bill to “restore fairness
and reliability to the medical justice system and promote patient safety
by fostering alternatives to current medical tort litigation.”
S.1355
Enzi also offered a bill on the adoption of health information technology
and to improve the quality and reduce the costs of healthcare.
S.1357
Legislation proposed by Sen. Tom Harkin (D-IA) would provide the Secretary
of Agriculture the authority to prescribe performance standards for
the reduction of pathogens in meat, meat products, poultry, and poultry
products processed by establishments receiving inspection services
and to enforce the Hazard Analysis and Critical Control Point (HACCP)
System requirements, sanitation requirements, and the performance
standards.
H.R.3070
Rep. Ken Calvert (R-CA) introduced a NASA reauthorization bill.
H.R.3084
A bill offered by Rep. Cliff Stearns (R-FL) would require testing for
steroids and other performance-enhancing substances for certain sports.
H.R.3131
Rep. Fred Upton (R-MI) proposed amendments to the “Healthy Start
Initiative.”
H.R.3144
Rep. Roscoe Bartlett (R-MD) introduced a bill to provide for a program
at the National Institutes of Health to conduct and support research
in the derivation and use of human pluripotent stem cells by means
that do not harm human embryos.
H.R.3151
A bill offered by Rep. Benjamin Cardin (D-MD) would remove the exclusion
of benzodiazepines from required coverage under the Medicare prescription
drug program.
H.R.3154
Rep. Barbara Cubin proposed a bill to provide incentives for pharmaceutical
companies, biotechnology companies, and medical device companies
to invest in research and development with respect to antibiotic
drugs, antivirals, diagnostic tests, and vaccines that may be used
to identify, treat, or prevent an infectious disease.
H.R.3156
Rep. Susan Davis offered a bill on dietary supplements.
H.R.3160
Legislation proposed by Rep. Anna Eshoo would provide the Secretary
of Agriculture the authority to prescribe performance standards for
the reduction of pathogens in meat, meat products, poultry, and poultry
products processed by establishments receiving inspection services
and to enforce the Hazard Analysis and Critical Control Point (HACCP)
System requirements, sanitation requirements, and the performance
standards.
H.R.3166
A bill offered by Rep. Raul Grijalva (D-AZ) would provide compensation
to livestock operators who voluntarily relinquish a grazing permit
or lease on Federal lands where conflicts with other multiple uses
render livestock grazing impractical.
H.R.3170
Rep. Steve King (R-IA) introduced legislation that would establish
a Livestock Identification Board to create and implement a mandatory
national
livestock identification system.
H.R.3196
Rep. Henry Waxman proposed a bill that would expand the scope of information
required for the data bank on clinical trials of drugs.
Return to top
Inside
Track is produced as a service to clients of Policy Directions,
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