[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3758 Introduced in House (IH)]






108th CONGRESS
  2d Session
                                H. R. 3758

  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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 3, 2004

  Mr. Emanuel (for himself, Mr. Shimkus, Ms. DeGette, and Mr. Engel) 
 introduced the following bill; which was referred to the Committee on 
   Energy and Commerce, and in addition to the Committee on Ways and 
 Means, for a period to be subsequently determined by the Speaker, in 
   each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 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.

    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 ``Flu Protection Act of 2004''.

                TITLE I--FLU VACCINE AWARENESS CAMPAIGN

SEC. 101. AWARENESS CAMPAIGN AND EDUCATION AND OUTREACH EFFORTS.

    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:

                    ``Subtitle 3--Influenza Vaccine

        ``awareness campaign and education and outreach efforts

    ``Sec. 2141. (a) Campaign.--The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention (in this 
subtitle 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, efficacy, 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 2004 through 2008.''.

           TITLE II--ENCOURAGING VACCINE PRODUCTION CAPACITY

SEC. 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 (2), by 
        striking the period at the end of paragraph (3) and inserting 
        ``, and'', and by adding at the end the following new 
        paragraph:
            ``(4) the vaccine manufacturing facilities investment 
        credit.''.
            (2) Amount of credit.--Section 48 of such Code is amended 
        by adding at the end the following new subsection:
    ``(c) Vaccine Manufacturing Facilities Investment Credit.--
            ``(1) 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.
            ``(2) Qualified investment.--For purposes of paragraph (1), 
        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.
            ``(3) Vaccine manufacturing facilities property.--For 
        purposes of this subsection, 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.
            ``(4) 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.
            ``(5) Termination.--This subsection shall not apply to any 
        property placed in service after December 31, 2008.''.
    (b) Technical Amendments.--
            (1) Subparagraph (C) of section 49(a)(1) of such Code is 
        amended by striking ``and'' at the end of clause (ii), by 
        striking the period at the end of clause (iii) and inserting 
        ``, and'', and by adding at the end the following new clause:
                            ``(iv) the basis of any vaccine 
                        manufacturing facilities property.''.
            (2) Subparagraph (E) of section 50(a)(2) of such Code is 
        amended by inserting ``or 48(c)(4)'' before the period.
            (3)(A) The section heading for section 48 of such Code is 
        amended to read as follows:

``SEC. 48. OTHER CREDITS.''.

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

``Sec. 48. Other credits.''.
    (c) Effective Date.--The amendments made by this section shall 
apply to property placed in service after December 31, 2003, 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 the enactment 
of the Revenue Reconciliation Act of 1990).

           TITLE III--ENSURING SUFFICIENT FLU VACCINE SUPPLY

SEC. 301. VACCINE SUPPLY.

    Subtitle 3 of title XXI of the Public Health Service Act, as added 
by section 101, is amended by adding at the end the following:

                            ``vaccine supply

    ``Sec. 2142. (a) Requests for More Doses.--
            ``(1) In general.--Not later than March 15 of each year, 
        the Director shall enter into a contract with one or more 
        manufacturers to produce such additional doses of the influenza 
        vaccine as determined necessary by the Director.
            ``(2) Content of contract.--A contract for additional doses 
        shall provide that the manufacturer will be compensated by the 
        Director at an equitable rate negotiated by the Director 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 Director to be produced 
                by such manufacturer.
            ``(3) When such vaccine purchases should take place.--The 
        Director may purchase from a manufacturer the doses for which 
        it has contracted at any time after which it is determined by 
        the Director, in consultation with the manufacturer, that the 
        doses will likely not be absorbed by the private market.
    ``(b) Contingency Plan.--The Director 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.''.

             TITLE IV--PREPARING FOR A PANDEMIC OR EPIDEMIC

SEC. 401. PREPARATION FOR INFLUENZA PANDEMIC OR EPIDEMIC.

    Subtitle 3 of title XXI of the Public Health Service Act, as added 
by section 101 and amended by section 301, is further amended by adding 
at the end the following:

            ``preparation for influenza pandemic or epidemic

    ``Sec. 2143. (a) Establishment of a Protocol.--The Secretary, 
acting through the Director, shall 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.
    ``(b) Contents of Protocol.--The protocol established under 
subsection (a) shall--
            ``(1) address methods to coordinate dissemination of the 
        influenza vaccine to key populations in the event of an 
        influenza pandemic or epidemic;
            ``(2) address 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;
            ``(3) improve upon the current influenza vaccines and 
        production and dissemination methods;
            ``(4) address alternative ways to manufacture or produce 
        the influenza vaccine;
            ``(5) address how many doses of the influenza vaccine 
        should be produced on an annual basis and which strains of 
        influenza should be covered by such vaccine in a particular 
        year;
            ``(6) address public awareness and education, and 
        professional education on the need to receive an influenza 
        vaccine;
            ``(7) address alternative methods to prevent the spread of, 
        and complications associated with, influenza, including 
        antiviral medications;
            ``(8) address a tracking method for publicly and privately 
        sold doses of the influenza vaccine to enable the Director 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
            ``(9) address other issues determined by the Director to be 
        appropriate.
    ``(c) Coordination; Preparation; Prevention.--In establishing the 
protocol under subsection (a), the Director shall--
            ``(1) coordinate with health care providers, manufacturers, 
        research institutions, health care organizations, and other 
        expert stakeholders;
            ``(2)(A) conduct international and national surveillance;
            ``(B) build State surveillance capacity;
            ``(C) collect influenza vaccine safety and efficacy data; 
        and
            ``(D) engage in epidemiological studies and research on 
        novel influenza viruses;
            ``(3) 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; and
            ``(4) develop systems to routinely measure the impact of 
        influenza on pediatric and high-risk populations.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $100,000,000 for each of fiscal 
years 2004 through 2008.''.

         TITLE V--NOTICE OF INTENT TO WITHDRAW FROM THE MARKET

SEC. 501. MANUFACTURER WITHDRAWAL FROM THE MARKET.

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

       ``Subtitle 4--Notice of Intent to Withdraw From the Market

               ``manufacturer withdrawal from the market

    ``Sec. 2151. Any manufacturer of a vaccine that receives authority 
under Federal law to distribute such vaccine shall provide advance 
notification to the Department of Health and Human Services regarding 
such manufacturer's intent to stop the distribution of such vaccine 
into the marketplace.''.
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