S. 2456Senate110th Congress (2007-2009)In Committee

Influenza Vaccine Security Act of 2007

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SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

December 12, 2007

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SenateIntro Referral

Introduced in Senate

December 12, 2007

SenateIntro Referral

Sponsor introductory remarks on measure. (CR S15247-15248)

December 12, 2007

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

December 12, 2007

Floor Debate

5 members

What members said about S. 2456 on the floor

1 Republican4 Democrats

Sen. Christopher J. DoddD-CT · Dec 12, 2007

Mr. President, today we are facing a crisis in the mortgage markets on a scale that has not been seen since the Great Depression: over 2 million homeowners face foreclosure at a loss of over $160…

Mr. President, today we are facing a crisis in the mortgage markets on a scale that has not been seen since the Great Depression: over 2 million homeowners face foreclosure at a loss of over $160 billion in hard-earned home equity; the Conference of Mayors recently reported, November 26, 2007, that they expect a decline of $1.2 trillion in property values in 2008 because of the crisis; over one out of every 5 subprime loans is currently delinquent according to First American Loan Performance, an industry research firm. These high default rates have frozen the subprime and jumbo mortgage markets and infected the capital markets to the point where central banks around the world have had to inject liquidity into the system to avoid the crisis from spreading to other segments of the market.

One of the fundamental causes of this serious crisis is abusive and predatory subprime mortgage lending. The Homeownership Preservation and Protection Act of 2007, which I am introducing today with a number of my colleagues, is designed to protect American homeowners from these practices, and prevent this disaster from happening again. The legislation will: realign the interests of the mortgage industry with borrowers to insure the availability of mortgage capital on fair terms both for the creation and sustainability of homeownership; establish new lending standards to ensure that loans are affordable and fair, and provide for adequate remedies to make sure the standards are met; and create

a transparent set of rules for the mortgage industry so that capital can safely return to the market without bad lending practices driving out the good.

The fundamental problem in the subprime market today is that the mortgage system has become extremely fragmented, with different entities responsible for selling, underwriting, originating, funding, and securitizing the loans. Too few of these entities have a stake in the long-term success of the mortgage. A recent article in The Economist, February 17, 2007, described the process succinctly:

Banks are traditionally supposed to know a bit about the

borrowers on their books. But, in many cases, their loans did

not stay on their books long enough for them to care.

Mortgages were written for a fee, sold to investment banks

for a fee, then packaged and floated for another fee. At each

link in the chain, the fees mattered more than the quality of

the loans. . . .

As the GAO concluded, ``Originators [mortgage brokers and lenders] had financial incentives to increase loan volume, partially at the expense of loan quality,'' October 10, 2007. For example, mortgage originators have an incentive to get a borrower to take out a larger loan than he or she needs, and at a higher interest rate than that for which the borrower would qualify, because the originator gets a higher commission for such loans.

Comptroller of the Currency John Dugan recently described the corrosive impact of this system on underwriting standards. In a speech to the American Bankers Association October 9, 2007, Mr. Dugan said:

When a bank makes a loan that it plans to hold, the

fundamental standard it uses to underwrite the loan is that

most basic of credit standards that . . . the underwriting

must be strong enough to create a reasonable expectation that

the loan will be repaid. But when a bank makes a loan that it

plans to sell, then the credit evaluation shifts in an

important way: the underwriting must be strong enough to

create a reasonable expectation that the loan can be sold or

put another way, the bank will underwrite to whatever

standard the market will bear.

The vast majority of subprime loans were made to be sold, and, hence, their underwriting standards simply were not sufficient to ensure a reasonable prospect of repayment for too many Americans.

While the focus of much of the news coverage has been on the impact of the crisis on financial institutions and markets, I ask my colleagues to keep in mind the affect this is having on individuals who are losing their homes, and on their neighbors, who are seeing their home equity erode as foreclosures in their neighborhoods increase.

It is important to keep in mind that only about 10 percent of subprime mortgages in the past several years have been made to first time home buyers. This market has not been primarily about creating a new set of homeowners; a majority of subprime loans have been refinances. While maintaining access to subprime credit on fair terms is important, too much of the subprime market in the past several years has actually put the homes and home equity of American families at risk.

The legislation seeks to set high standards for brokers, lenders, appraisers, servicers, and Wall Street and provide for strong remedies to restore accountability to the system. Specifically, the legislation will establish new protections for all borrowers including a prohibition on steering prime borrowers to subprime loans, which the Wall Street Journal recently found was widespread in the market. The bill establishes a fiduciary duty for mortgage brokers towards borrowers. It provides for a duty of good faith and fair dealing toward borrowers for all lenders.

The bill will establish new protections for subprime borrowers and borrowers who get exotic mortgages. First and foremost, brokers and lenders will have to establish the borrowers' ability to repay the loan, including for interest-only and option ARMs. In addition, the bill prohibits prepayment penalties and YSPs on these loans, and requires that these loans provide a net tangible benefit to the borrower.

The bill will tighten the definition of high cost loans and provide increased protections for these borrowers, including a prohibition of balloon payments, financing of points and fees, prepayment penalties and yield spread premiums, YSPs.

The bill will provide strong remedies to make sure these standards are met. The bill puts more ``cops on the beat'' by allowing state attorneys general to enforce the provisions of the law, and it does not preempt State law. States should be allowed the flexibility to address new abuses as they arise.

The bill will provide for limited liability for holders of a mortgage made in violation of law, whether it is the original lender or a subsequent investment trust. Unlike current law, which puts the burden on the borrower to find the party responsible for causing the harm, the legislation allows the borrower to go directly to the current mortgage holder for a cure.

The bill will also prohibit lenders from influencing appraisers, limit the ``junk'' fees mortgage servicers can charge, and require them to credit payments promptly, require foreclosure prevention counseling or loss mitigation before a foreclosure can take place, and uuthorize the hiring of additional FBI agents to fight mortgage fraud.

In the coming months, the housing crisis is going to get worse. We will need to continue to press lenders and servicers to provide real relief for homeowners threatened with foreclosure. FHA and the GSEs will have to play an expanded role. But as we deal with the cleaning up the current crisis, let us keep in mind the need to address the underlying problems that have created the crisis, and move to address those underlying causes by passing the ``Homeownership Protection and Preservation Act.''

Finally, I want to acknowledge the work of a number of my colleagues on this issue. Senators Schumer, Brown, and Casey introduced a bill on this topic earlier this year, S. 1299, from which I took some important provisions. In addition, Senators Reed and Menendez both made important contributions to the deliberations leading up to the introduction of this legislation.

Mr. President, I ask unanimous consent that the text of the bill and a detailed summary be printed in the Record.

Sen. Jeff BingamanD-NM · Dec 12, 2007

Mr. President, I rise today with my colleagues Senators Dole, Durbin, Feinstein, Stabenow, Salazar, Kerry, Brown, McCaskill, Schumer, Boxer, Levin, Bayh, Burr, Martinez, Clinton, Pryor, Leahy,…

Mr. President, I rise today with my colleagues Senators Dole, Durbin, Feinstein, Stabenow, Salazar, Kerry, Brown, McCaskill, Schumer, Boxer, Levin, Bayh, Burr, Martinez, Clinton, Pryor, Leahy, Lincoln, Hutchison, Chambliss, Rockefeller, and Isakson to introduce legislation vitally important to the ability of our States to continue to fund their Medicaid programs and ensure access to health care services for low-income constituents. The legislation would extend the existing 1 year moratorium for an additional year on a

CMS rule limiting Medicaid payments to public and teaching hospitals as well as the ability of States to fund critical healthcare programs for rural residents such as through Sole Community Hospital programs.

On January 18, 2007, the Centers for Medicare and Medicaid Services, CMS, published a proposed rule entitled ``Medicaid Program; Cost Limit for Providers Operated by Units of Government and Provisions to Ensure the Integrity of Federal- State-Financial Partnership'' that would make sweeping changes to public and other safety net provider payment and financing arrangements with State Medicaid programs. The proposed rule would: impose a cost limit on Medicaid payments to public and other safety net providers; impose a new Federal definition of public provider status; and, greatly restrict the sources of non-Federal share funding through intergovernmental transfers, IGTs, and certified public expenditures, CPEs.

National advocates report that over 400 comment letters were submitted to CMS on the proposed rule, none of which expressed support for the rule and the overall majority of which called for its withdrawal. In addition, a budget neutral reserve fund to block this regulation was introduced by me and approved by the Senate this year.

CMS subsequently issued an additional regulation that would force billions of dollars in additional Medicaid payment reductions to teaching hospitals, many of whom are public hospitals, hampering the ability of those providers to provide essential services including the education of the next generation of medical professionals despite a shortage of medical professionals. The proposed regulations would cut at least $5 billion in Medicaid funding for safety net hospitals nationwide over 5 years--weakening their effectiveness for all of us and jeopardizing the health of millions of vulnerable children and families.

In response to these rules, 66 Senators and 283 Members of the House have gone on record in opposition to the rules since they were released earlier this year. This includes a majority of the Finance Committee including Senators: Roberts, Snowe, Smith, Rockefeller, Kerry, Bingaman, Salazar, Stabenow, Wyden, Lincoln, Schumer, and Cantwell.

Furthermore, Congress showed its strong opposition to the rules by including a one-year moratorium in the recent supplemental appropriations bill, P.L. 110-28. The moratorium prohibits implementation of the rules for one year from the date of enactment of the supplemental. The supplemental was negotiated extensively by Congress and the White House and a deal was reached on May 23. On May 25--the day the President signed the supplemental, and the moratorium, into law--the administration put the final rule on display and published it in the Federal Register on May 29. The most damaging components of the proposed rule remain in the final rule, including Medicaid cuts limiting public and other safety net providers to cost.

Since then, CMS has issued a third rule of major concern to public and teaching hospitals. On September 28, 2007, CMS released a new proposed rule governing the calculation of the Medicaid outpatient upper payment limit, UPL. Many believe this action was in violation of the current moratorium enacted by Congress. For example, the outpatient regulation would exclude GME costs from the calculation of the Medicaid Outpatient UPL for all hospitals and would also eliminate many ancillary services from the UPL calculation for all-inclusive rate providers.

Major Medicaid reforms require a congressional role. By rushing to publish a final regulation, CMS has disregarded congressional opposition and attempted to usurp Congress's role. In addition, the status quo is now the administration's new policy, not what existed when Congress was in the process of enacting the moratorium. CMS's action requires states to prepare for implementation of the regulation and expend administrative resources to do so--all of this before Congress has the opportunity to address the key policy issues contained in the regulation.

I urge my colleagues to join me in supporting this important legislation.

Mr. President, I ask unanimous consent that the text of the bill and letters of support be printed in the Record.

Sen. Hillary Rodham ClintonD-NY · Dec 12, 2007

Mr. President, today I join my colleague, Senator Pat Roberts, in introducing the Influenza Vaccine Security Act. Senator Roberts and I first introduced this legislation during the 109th Congress, in response to seasonal flu vaccine shortages, as well as the growing awareness of the need for pandemic flu preparedness. Some of these provisions were incorporated into law, but the overall need to address problems in education, tracking, and distribution related to seasonal influenza vaccine have not changed.

About 36,000 Americans die from the flu every year, and 200,000 more are hospitalized due to complications from the flu. These complications and deaths are largely preventable with a simple flu shot. Yet the process of getting a flu shot is not always simple. Since 2000, our Nation has experienced multiple shortages of flu vaccine prior to Thanksgiving, when demand is highest. What we have also experienced-- and what received less attention--is the fact that at the end of the flu season, we often have surpluses. The millions of doses that were in such high demand earlier in the season go unused. We need to bring some stability into the vaccine market, to ensure that we have vaccine at periods of high demand, and also sustain demand beyond the limited early-season period.

The Influenza Vaccine Security Act will help create a stable flu vaccine market for manufacturers by increasing coordination between the public and private sectors so that we can set targets and procedures for dealing with both shortages and surpluses before they hit. It will also create a buyback provision so that we can direct late-season surplus vaccine to public health and bioterrorism prevention efforts, instead of having it go to waste. The legislation will increase demand for vaccine by improving education and outreach to populations with historically low rates of influenza vaccination.

Of course, vaccines do us no good if they can't get to the people who need them, and in past shortages, we had problems matching existing stocks of vaccine to the high priority populations, like senior citizens, who needed vaccines right away. The Influenza Vaccine Security Act also sets up a tracking system so the CDC and state and local health departments can share the information they need to ensure that high priority populations will have access to vaccines. This tracking system is critical and will provide fundamental infrastructure necessary not only to deal with our annual flu season, but avian or other pandemic outbreaks.

This legislation is supported by Trust for America's Health, the American Lung Association, the American Public Health Association, the National Association of County and City Health Officials, the American Academy of Pediatrics, the American Academy of Physician Assistants, the American College of Occupational and Environmental Medicine, the Association of American Medical Colleges, the Association for Professionals in Infection Control and Epidemiology, the Allergy & Asthma Network, Mothers of Asthmatics, the Asthma and Allergy Foundation of America, the Center for Biosecurity at the University of Pittsburgh Medical Center, the Center for Infectious Disease Research & Policy, the Immunization Coalition of Washington, DC, and the Service Employees International Union.

Mr. President, I ask unanimous consent to have letters of support printed in the Record.

Sen. Hillary Rodham ClintonD-NY · Dec 12, 2007

Mr. President, I ask unanimous consent to have letters of support printed in the Record.

Sen. Daniel K. AkakaD-HI · Dec 12, 2007

Mr. President, for the last few weeks, the administration has increased its rhetoric about a looming budget shortfall at the Department of Defense unless Congress passes an emergency spending bill. Most recently, the President threatened to lay off hundreds of thousands of Federal workers at DoD to make up for any shortfalls. This is simply unacceptable.

The Pentagon said as late as last week that the Department has sufficient funds in order to keep our fighting men and women in Iraq and Afghanistan supplied through late February to mid-March of next year. Nonetheless, the administration continues to threaten to layoff workers to make up for a non-existent gap in funding. The Department of Defense should not use Federal employees as pawns because the White House is playing politics with the budget.

As Chairman of the Governmental Affairs Oversight of Government Management and Federal Workforce Subcommittee and the Armed Services Readiness Subcommittee, I have made oversight Government contracting a priority. In several hearings, I have heard officials and whistleblowers testify about the systemic waste, fraud and abuse, in many contracts. If the administration wants to save money, it should start increasing oversight over contracts and drop those that are not performing.

Rather than increasing their efforts to eliminate waste, fraud, and abuse in contracting that costs us billions every year, this administration would rather lay off patriotic civilian Federal employees who have dedicated their careers to the Federal Government. The Federal Government is already facing looming crisis in retirements and is working hard to recruit new workers to fill vacancies. Using Federal workers to make a political statement is wrong. It sends a negative message to prospective employees and hurts recruitment efforts in the long run.

Instead of looking to cut the Federal workforce to save money, the President should be holding contractors accountable to reduce costs and ensure

that our fighting men and women in Iraq and Afghanistan have the supplies they need.

Today, I am introducing a bill that would send a clear message to the administration that Federal workers are not bargaining chips.

The idea behind this legislation is simple, rather than laying off Federal workers to close a budget shortfall, the Pentagon should suspend contracts for non-essential services. Many service contractors work side-by-side with Federal workers. There is no reason that Federal workers should get a pink slip for Christmas while the Pentagon continues to spend millions on contractors.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

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Sen. Norm ColemanR-MN · Dec 12, 2007

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

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Introduced in SenateIssued December 12, 2007

110th CONGRESS

1st Session

S. 2456

IN THE SENATE OF THE UNITED STATES

December 12, 2007

Mr. Reid (for Mrs. Clinton (for herself and Mr. Roberts)) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Public Health Service Act to improve and secure an adequate supply of influenza vaccine.

Short title

This Act may be cited as the Influenza Vaccine Security Act of 2007.

Market Guarantees

101.

Amendment to the Public Health Service Act

Title XXI of the Public Health Service Act (42 U.S.C. 300aa–1 et seq.) is amended by adding at the end the following:

Influenza vaccine security

2141.

Establishment of an influenza vaccine target and stockpile

(a)

Annual target

The Secretary, in consultation with the Advisory Committee on Immunization Practices to the Centers for Disease Control and Prevention (referred to in this subtitle as the Advisory Committee), shall determine an annual production target for influenza vaccine, based on the recommendations of the Advisory Committee. Based on such target, the Secretary, acting through the Centers for Disease Control and Prevention, shall coordinate with the private market to encourage the production of such vaccine in amounts that will meet the annual target.

(b)

Stockpile

Prior to the start of each annual influenza season (as determined by the Secretary), the Secretary is authorized to purchase and store from multiple manufacturers an amount not to exceed 10 percent of the total amount of influenza vaccine, including one or more active vaccine antigen ingredients in bulk or filled form, that is designated for production by the Advisory Committee for placement in the strategic national stockpile under section 121 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (referred to in this subtitle as the strategic national stockpile). Such vaccine shall be held in reserve to be used in the event of a vaccine shortage in a given influenza season. The Secretary shall coordinate with the manufacturers involved to ensure that reserving amounts of vaccine for the stockpile does not interfere with the early season delivery or early season administration of vaccine to high priority populations (as defined by the Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention) (referred to in this subtitle as high priority populations).

2142.

Vaccine buyback program

(a)

In general

The Secretary shall establish an influenza vaccine buyback protocol under which the Secretary may enter into buyback contracts with manufacturers of influenza vaccine to purchase such manufacturers' excess stocks of influenza vaccine so long as such vaccine has been manufactured in accordance with the recommendations of the Advisory Committee for the production of seasonal influenza vaccine.

(b)

Manufacturers

The Secretary shall have the discretion to award buyback contracts under subsection (a) to several influenza vaccine manufacturers in a manner consistent with the goal of providing stability in the influenza vaccine market, as long as the Federal Government purchases not more than 50 percent of the excess influenza vaccine stock of any single manufacturer at market price.

(c)

Cooperation with manufacturers, distributors, and wholesalers

As a condition of participation in the buyback program under this section, the Director of the Centers for Disease Control and Prevention shall work in cooperation with influenza vaccine manufacturers and wholesalers and distributors within the chain of custody from factory to health care institution or health care providers to share pertinent information that will allow for the tracking of influenza vaccine, maximize the delivery and availability of influenza vaccines to high priority populations, and ensure that influenza vaccine is delivered on an equitable basis, particularly in times of vaccine shortages.

(d)

Confidentiality

The information submitted to the Centers for Disease Control and Prevention or its contractors, if any, under subsections (c) and (d) shall remain confidential in accordance with the exception from the public disclosure of trade secrets, commercial or financial information, and information obtained from an individual that is privileged and confidential, as provided for in section 552(b)(4) of title 5, United States Code, and subject to the penalties and exceptions under sections 1832 and 1833 of title 18, United States Code, relating to the protection and theft of trade secrets, and subject to privacy protections that are consistent with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. None of such information provided by a manufacturer, wholesaler, or distributor shall be disclosed without its consent to another manufacturer, wholesaler, or distributor, or shall be used in any manner to give a manufacturer, wholesaler, or distributor a proprietary advantage over its competitors.

(e)

Ability To negotiate

The Secretary shall have the ability to negotiate, on a case-by-case basis, the submission of information under subsection (c), as long as the information provided will achieve the goals of tracking of the influenza vaccine, maximizing the delivery and availability of influenza vaccines to high priority populations, and ensuring that influenza vaccine is delivered on an equitable geographical basis, particularly in times of vaccine shortages.

(f)

Notice

(1)

In general

For purposes of maintaining and administering the supply of vaccines described under subsection (a), the Secretary shall by contract require that a manufacturer of a vaccine included in such supply provide not less than 12 months notice to the Secretary of a purposeful discontinuance of the manufacture of such vaccine by the manufacture of the vaccine.

(2)

Reduction of period of notice

The notification period required under paragraph (1) shall not apply in a case in which vaccine production is interrupted because of unforeseen manufacturing concerns.

(g)

Use of vaccine post buyback

Following the buyback of vaccine under this section, the Secretary shall direct that any vaccine purchased in such buyback be used for the following activities:

(1)

Use in late-season mass vaccination exercises conducted in coordination with Federal, State or local agencies engaged in emergency preparedness and bioterrorism preparedness activities. Such exercises should be carried out in partnership with voluntary organizations working to improve emergency preparedness and bioterrorism preparedness.

(2)

Promoting and carrying out late-season vaccination through the Indian Health Service, the Public Health Service, the Department of Veterans Affairs, or through other federally funded health care providers, such as community health centers and rural health clinics.

(3)

Other activities approved by the Secretary.

2143.

Critical supply purchase program

(a)

In general

The Secretary shall increase the amount of antiviral medications, N–95 respirator masks, and other protections and treatments, as determined necessary by the Secretary as they become available, to treat and prevent pandemic influenza, in the strategic national stockpile. In increasing such amounts, the Secretary shall consult with the Director of the Centers for Disease Control and Prevention and the Assistant Secretary for Preparedness and Response, to determine the amounts that are necessary to provide adequate protection to not less than the number of individual who respond to an influenza epidemic.

(b)

Pediatric programs

The Secretary is encouraged to consult with all relevant Federal agencies and the private sector to develop and approve N–95 respirators and other protections and treatments, as determined necessary by the Secretary, to treat and prevent pandemic influenza, and shall ensure that such products are represented in adequate amounts in the strategic national stockpile to provide adequate protection to pediatric populations in the United States.

2144.

Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary to carry out this subtitle in each of fiscal years 2008 through 2012.

Food and Drug Administration assistance to manufacturers

201.

Amendment to the Food, Drug, and Cosmetic Act

Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following:

909.

Provisions related to the emergency acquisition of vaccines

(a)

In general

(1)

Increased communication

The Food and Drug Administration shall carry out activities to increase communication between the agency and the scientific community regarding vaccine development and regulation, including participation in conferences on the science related to infectious diseases, influenza, biologic manufacturing, and other issues as determined appropriate by the Director of the Center for Biologics Evaluation and Research.

(2)

Regulatory roadmap

The Commissioner, in consultation with the Director of the Centers for Disease Control and Prevention, the Secretary, and other agencies or participants as determined appropriate by the Secretary, shall develop a regulatory roadmap to address the following issues surrounding emergency use authorization of influenza vaccine, as determined by the Secretary during a public health emergency involving an actual or imminent outbreak of naturally occurring or engineered seasonal influenza:

(A)

Policies for the emergency use authorization of influenza vaccine that is produced and sold in other countries so that such vaccine may be imported into the United States by the United States Government during a vaccine shortage.

(B)

Policies for the facilitation of the distribution of any such vaccine imported into the United States during a vaccine shortage, including the interstate transportation, allocation and equitable distribution of vaccine among high priority populations (as defined by the Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention) during an emergency use situation.

(C)

Policies for the communication and coordination of a response to an emergency use authorization with State and local health departments, including guidelines for notification of such entities in such situations.

(D)

Policies for the emergency use authorization of vaccines that are in clinical development in both the United States and other countries, including clarification of IND protocols for such vaccines, particularly those using new vaccine development technologies.

(3)

Consultation

In developing the roadmap under paragraph (2), the Commissioner shall solicit input from private and nonprofit stakeholders, including State and local health officials, and such input shall include recommendations for developing emergency use authorization guidelines that maintain the scientific and regulatory standards of the Food and Drug Administration.

(4)

Standing orders

(A)

Development

The Secretary shall direct the Centers for Disease Control and Prevention, in conjunction with State and local health departments and representatives of State medical boards and nursing examiners, to develop and publish a model standing order that will, at a minimum, address the need for standing orders to administer influenza vaccine in hospitals, community health centers, nursing homes, and other assisted living facilities, and by home health care providers. The Centers for Disease Control and Prevention is encouraged to expand such a model standing order to take into account—

(i)

the administration of other Medicare covered vaccines; and

(ii)

the delivery of influenza vaccine to patients in children's hospitals or other institutions serving the long-term care needs of a pediatric population, including those in a non-clinical setting.

(B)

Implementation

Not less than 1 year after the publication of the standing order under paragraph (A), States shall be required to implement such standing order in order to be eligible to receive grants under this Act.

(C)

Rule of construction

Nothing in this paragraph shall be construed as precluding the application of State laws, so long as such laws do not restrict the implementation of this requirements of the Influenza Vaccine Security Act of 2007 (and the amendments made by such Act).

(b)

Authorization of appropriations

There are authorized to be appropriated to carry out this section, $5,000,000 for fiscal year 2008, and such sums as may be necessary for each of fiscal years 2009 through 2012, to be made available to the Food and Drug Administration to provide the technical assistance and take advantage of the training opportunities as designated in this section.

III

Vaccine education, outreach, and coordination

301.

Authority of the National Center for Immunization and Respiratory Diseases for coordination, education, outreach, and communication across HHS

Section 2102 of the Public Health Service Act (42 U.S.C. 300aa–2) is amended—

(1)

in subsection (a), by adding at the end the following:

(10)

Coordination of support

The Director of the Center, in consultation with the Director of the National Institute for Allergy and Infectious Disease, shall—

(A)

coordinate efforts in regard to all influenza vaccine education, outreach, surveillance, and research activities within the Department in support of the goal of—

(i)

increasing overall influenza vaccination rates in the United States, particularly those of high priority populations (as defined by the Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention) and health care providers;

(ii)

increasing vaccination rates among medically underserved populations with low vaccination rates; and

(iii)

any other vaccine promotion activities as directed by the Secretary;

(B)

coordinate educational efforts under this paragraph with the National Vaccine Program Office, State and local health departments, the National Institutes of Health, and all other relevant Federal and other entities as designated by the Director; and

(C)

provide an annual report to Congress on the progress being made toward the goals described in subparagraph (A).

; and

(2)

by adding at the end the following:

(c)

Appropriations for coordination of influenza vaccine outreach activities

There is authorized to be appropriated to carry out activities under subsection (a)(10), $2,000,000 for each of fiscal years 2008 through 2012.

Increased influenza vaccine and outbreak surveillance activities

401.

Tracking network and demonstration grants

Title III of the Public Health Service Act is amended by inserting after section 319B (42 U.S.C. 247d–2) the following:

319B–1.

Tracking network and demonstration grants

(a)

Tracking system

(1)

Establishment

Not later than 2 years after the date of enactment of this section, the Director of the Centers for Disease Control and Prevention, in conjunction with State and local public health officials and health provider and nonprofit organizations, shall establish an electronic tracking system through which the Director and such officials can determine the amount of influenza vaccine within a 24-hour window that is available for distribution to patients, as well as the need for such vaccine on a county-by-county basis, and the progress of vaccine delivery and distribution efforts at the State and local level.

(2)

Estimates

The tracking system established under paragraph (1) shall collect estimates of the size of high priority populations (as defined by the Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention) (referred to in this section as high priority populations) in each county in the United States, so as to better determine where influenza vaccine resources may need to be directed in the case of an emergency.

(3)

Provision of information

To be eligible to participate in buyback programs the vaccine manufacturer shall provide information to the tracking system as the Director of the Centers for Disease Control and Prevention determines appropriate in accordance with subtitle 3 of title XXI.

(4)

Confidentiality

The information submitted to the Secretary (or a contractors, if any) under this section or under any other section of this Act related to vaccine distribution information shall remain confidential in accordance with the exception from the public disclosure of trade secrets, commercial or financial information, and information obtained from an individual that is privileged and confidential, as provided for in section 552(b)(4) of title 5, United States Code, and subject to the penalties and exceptions under sections 1832 and 1833 of title 18, United States Code, relating to the protection and theft of trade secrets, and subject to privacy protections that are consistent with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. None of such information provided by a manufacturer, wholesaler, or distributor shall be disclosed without its consent to another manufacturer, wholesaler, or distributor, or shall be used in any manner to give a manufacturer, wholesaler, or distributor a proprietary advantage.

(5)

Guidelines

The Secretary, in order to maintain the confidentiality of relevant information and ensure that none of the information contained in the systems involved may be used to provide proprietary advantage within the vaccine market, while allowing State, local, and tribal health officials access to such information to maximize the delivery and availability of vaccines to high priority populations, during times of influenza pandemics, vaccine shortages, and supply disruptions, in consultation with manufacturers, distributors, wholesalers and State, local, and tribal health departments, shall develop guidelines permitting the Department of Health and Human Services to carry out paragraphs (1) and (2) and (3).

(b)

Expansion of current systems and activities

(1)

Surveillance system

Not later than 4 years after the date of enactment of this section, the Director of the Centers for Disease Control and Prevention shall upgrade and enhance the influenza surveillance system of the Centers for Disease Control and Prevention to report influenza data from State and local health departments into the tracking system established under subsection (a)(1).

(2)

Educational materials

The tracking system shall contain information to assist users in accessing influenza education, outreach, and communications tools, such as those developed and financed under the Influenza Vaccine Security Act of 2007 (and the amendments made by such Act).

(c)

Demonstration grants

(1)

In general

The Director of the Centers for Disease Control and Prevention shall award demonstration grants to State and local health departments to enable such departments to enter into contract with hospitals, community health centers, long-term care facilities, physicians’ offices, and health care facilities operated or funded by such departments to assist such department and entities in upgrading their information technology, infrastructure, and workforce in a manner that will allow such departments and entities to improve their ability to report and track influenza vaccine dissemination.

(2)

Priority

In awarding grants under paragraph (1), priority shall be given to departments and entities that serve high priority populations in medically underserved areas.

(d)

Authorization of appropriations

There are authorized to be appropriated—

(1)

to carry out subsection (a), $100,000,000 for each of fiscal years 2008 through 2012, of which $500,000 for each fiscal year shall be made available to implement subsection (b)(3); and

(2)

to carry out subsection (c), $100,000,000 for each of fiscal years 2008 through 2012.

Flu vaccine outreach and education

501.

Educational efforts and grants

Title III of the Public Health Service Act is amended by inserting after section 319B–1 (as added by section 401) the following:

319B–2.

Immunization educational efforts and grants

(a)

In general

The Director of the Centers for Disease Control and Prevention, in conjunction with State and local health departments, shall revise and expand the influenza-related educational materials to the Centers for Disease Control and Prevention, and facilitate the use of such materials by health care providers and patients. The Director is authorized to coordinate such educational efforts with nonprofit provider and patient advocacy groups.

(b)

Influenza vaccine education and outreach

(1)

In general

In order to achieve an optimal balance in the influenza vaccine market, and to ensure that the recommendations of the Advisory Committee on Immunization Practices to the Centers for Disease Control and Prevention for vaccine administration are carried out to the maximum extent possible, the Director of the Centers for Disease Control and Prevention, in conjunction with State and local health departments, shall carry out influenza immunization education and outreach activities that target physicians and other health care providers, health insurance providers, health care institutions and patients, particularly those in high priority populations (as defined by the Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention) (referred to in this section as high priority populations).

(2)

Types of activities

The education and outreach activities under paragraph (1) shall include—

(A)

activities to encourage voluntary participation in influenza vaccination programs, with the goal of increasing overall influenza vaccination rates in the United States, achieving full influenza vaccination of all high priority populations, and full use of each season’s influenza vaccine supply and late season vaccination;

(B)

the provision of information on influenza prevention, including to medically underserved communities with low vaccination rates;

(C)

activities to increase the number of healthcare providers who receive influenza vaccines each year; and

(D)

other influenza educational efforts determined appropriate by the Director.

(c)

Grants

The Director of the Centers for Disease Control and Prevention may award grants to State and local health departments to carry out activities to encourage individuals, particularly those from high priority populations, to seek out influenza vaccinations.

(d)

Collaboration

State and local health departments that receive grants under subsection (b) are encouraged to collaborate on projects with physicians and other health care providers, health insurance providers, health care institutions, and groups representing high priority populations.

(e)

Authorization of appropriations

In addition to any amounts otherwise available through the Secretary for influenza outreach and education, there is authorized to be appropriated to carry out this section, $10,000,000 for each of fiscal years 2008 through 2012.