S. 375

Flu Protection Act of 2005

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Contents

II

109th CONGRESS

1st Session

S. 375

IN THE SENATE OF THE UNITED STATES

February 15, 2005

Mr. Bayh (for himself, Mr. Craig, and Ms. Landrieu) introduced the following bill; which was read twice and referred to the Committee on Finance

A BILL

To amend the Public Health Service Act to provide for an influenza vaccine awareness campaign, ensure a sufficient influenza vaccine supply, and prepare for an influenza pandemic or epidemic, to amend the Internal Revenue Code of 1986 to encourage vaccine production capacity, and for other purposes.

1.

Short title

This Act may be cited as the Flu Protection Act of 2005.

I

Flu vaccine awareness campaign

101.

Awareness campaign and education and outreach efforts

Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end the following:

399O.

Awareness campaign and education and outreach efforts

(a)

Campaign

The Secretary, acting through the Director of the Centers for Disease Control and Prevention (in this section referred to as the Director), shall conduct a public awareness campaign and education and outreach efforts each year during the time period preceding the influenza season on each of the following:

(1)

The importance of receiving the influenza vaccine.

(2)

Which populations the Director recommends to receive the influenza vaccine to prevent health complications associated with influenza, including health care workers and household contacts.

(3)

Professional medical education of physicians, nurses, pharmacists, and other health care providers and such providers’ associated organizations.

(4)

Information that emphasizes the safety and benefit of recommended vaccines for the public good.

(b)

Outreach to Medicare recipients

(1)

In general

The Administrator of the Centers for Medicare & Medicaid Services shall, at the earliest possible time in the influenza vaccine planning and production process, reach out to providers of medicare services, including managed care providers, nursing homes, hospitals, and physician offices to urge early and full preordering of the influenza vaccine so that production levels can accommodate the needs for the influenza vaccine.

(2)

Rates of immunization among Medicare recipients

The Director shall work with the Administrator of the Centers for Medicare & Medicaid Services to publish the rates of influenza immunization among individuals receiving assistance under the medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).

(c)

State and public health adult immunization activities

The Director shall support the development of State adult immunization programs that place emphasis on improving influenza vaccine delivery to high-risk populations and the general population, including the exploration of improving access to the influenza vaccine.

(d)

Efficacy of vaccine

The Director shall work with appropriate agencies in conducting a study to assess the efficacy of the influenza vaccine.

(e)

Existing modes of communication

In carrying out the public awareness campaign and education and outreach efforts under subsections (a) and (b), the Director may use existing websites or structures for communication.

(f)

Authorization of appropriations

There are authorized to be appropriated to carry out this section $10,000,000 for each of fiscal years 2005 through 2009.

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II

Encouraging vaccine production capacity

201.

Incentives for the construction of vaccine manufacturing facilities

(a)

Vaccine manufacturing facilities investment tax credit

(1)

Allowance of credit

Section 46 of the Internal Revenue Code of 1986 (relating to amount of investment credit) is amended by striking and at the end of paragraph (1), by striking the period at the end of paragraph (2) and inserting , and, and by adding at the end the following new paragraph:

(3)

the vaccine manufacturing facilities investment credit.

.

(2)

Amount of credit

Subpart E of part IV of subchapter A of chapter 1 of such Code (relating to rules for computing investment credit) is amended by inserting after section 48 the following new section:

48A.

Vaccine manufacturing facilities credit

(a)

In general

For purposes of section 46, the vaccine manufacturing facilities investment credit for any taxable year is an amount equal to 20 percent of the qualified investment for such taxable year.

(b)

Qualified investment

(1)

In general

For purposes of subsection (a), the qualified investment for any taxable year is the basis of each vaccine manufacturing facilities property placed in service by the taxpayer during such taxable year.

(2)

Vaccine manufacturing facilities property

For purposes of this section, the term vaccine manufacturing facilities property means real and tangible personal property—

(A)
(i)

the original use of which commences with the taxpayer, or

(ii)

which is acquired through purchase (as defined by section 179(d)(2)),

(B)

which is depreciable under section 167,

(C)

which is used for the manufacture, distribution, or research and development of vaccines, and

(D)

which is in compliance with any standards and regulations which are promulgated by the Food and Drug Administration, the Occupational Safety and Health Administration, or the Environmental Protection Agency and which are applicable to such property.

(c)

Certain progress expenditure rules made applicable

Rules similar to rules of subsections (c)(4) and (d) of section 46 (as in effect on the day before the date of the enactment of the Revenue Reconciliation Act of 1990) shall apply for purposes of this subsection.

(d)

Termination

This subsection shall not apply to any property placed in service after December 31, 2009.

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(b)

Technical amendments

(1)

Clause (iii) of section 49(a)(1)(C) of such Code is amended to read as follows:

(iii)

the basis of any vaccine manufacturing facilities property.

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(2)

Subparagraph (E) of section 50(a)(2) of such Code is amended by inserting or 48A(c) before the period.

(3)

The table of sections for subpart E of part IV of subchapter A of chapter 1 of such Code is amended by inserting after the item relating to section 48 the following:

Sec. 48A. Vaccine manufacturing facilities credit.

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(c)

Effective date

The amendments made by this section shall apply to property placed in service after December 31, 2004, under rules similar to the rules of section 48(m) of the Internal Revenue Code of 1986 (as in effect on the day before the date of enactment of the Revenue Reconciliation Act of 1990).

III

Ensuring sufficient flu vaccine supply

301.

Vaccine supply

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:

3

Influenza Vaccine

2141.

Vaccine supply

(a)

Requests for more doses

(1)

In general

Not later than March 15 of each year, the Secretary shall enter into contracts with manufacturers to produce such additional doses of the influenza vaccine as determined necessary by the Secretary.

(2)

Content of contract

A contract for additional doses shall provide that the manufacturer will be compensated by the Secretary at an equitable rate negotiated by the Secretary and the manufacturer for any doses that—

(A)

were not sold by the manufacturer through routine market mechanisms at the end of the influenza season for that year; and

(B)

were requested by the Secretary to be produced by such manufacturer.

(3)

When such vaccine purchases should take place

The Secretary may purchase from the manufacturer the doses for which it has contracted at any time after which it is determined by the Secretary, in consultation with the manufacturer, that the doses will likely not be absorbed by the private market.

(b)

Contingency plan

The Secretary shall encourage States to develop a contingency plan, in coordination with the Department of Health and Human Services, for maximizing influenza immunization for high-risk populations in the event of a delay or shortage of the influenza vaccine.

(c)

Authorization of appropriations

There are authorized to be appropriated to carry out this section such sums as may be necessary.

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IV

Preparing for a pandemic or epidemic

401.

Preparation for influenza pandemic or epidemic

Subtitle 3 of title XXI of the Public Health Service Act, as added by section 301, is amended by adding at the end the following:

2142.

Preparation for influenza pandemic or epidemic

(a)

Establishment of a protocol

The Secretary, acting through the Director of the National Vaccine Program (referred to in this section as the Director of the Program), shall continue progress on the pandemic preparedness plan and, in consultation with the Director of the Centers for Disease Control and Prevention, establish a protocol to attempt to prevent, prepare for, and respond to an influenza pandemic or epidemic. Such protocol shall be updated as determined appropriate by the Director of the Program.

(b)

Contents of protocol

The protocol established under subsection (a) shall—

(1)

improve upon the current influenza vaccines and production and dissemination methods; and

(2)

address—

(A)

methods to coordinate dissemination of the influenza vaccine to key populations in the event of an influenza pandemic or epidemic;

(B)

expansion of influenza vaccine manufacturing capacity (including making advance arrangements for ensuring the availability of raw materials) to respond to the needs of the United States during an influenza pandemic or epidemic;

(C)

alternative ways to manufacture or produce the influenza vaccine;

(D)

alternative methods to prevent the spread of, and complications associated with, influenza, including antiviral medications;

(E)

vaccine manufacturing capacity, production, and dissemination to improve preparedness for immediate pandemic threats, which may include avian influenza;

(F)

a tracking method for publicly and privately sold doses of the influenza vaccine to enable the Director of the Program to determine, after consultation with manufacturers of the influenza vaccine, how much supply is in circulation in the case of an influenza pandemic or epidemic; and

(G)

other issues determined by the Director of the Program to be appropriate.

(c)

Coordination; preparation; prevention

In establishing the protocol under subsection (a), the Director of the Program shall—

(1)

coordinate with health care providers, manufacturers, research institutions, health care organizations, and other expert stakeholders;

(2)

continue building international and national surveillance capacity;

(3)

continue to engage in epidemiological studies and research on novel influenza viruses; and

(4)

assist States with preparedness activities for a rapid State and local response to an influenza pandemic, including exploring methods of making the influenza vaccine more accessible to the general population.

(d)

Authorization of appropriations

There are authorized to be appropriated to carry out this section $150,000,000 for each of fiscal years 2005 through 2009.

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