[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2968 Introduced in Senate (IS)]







108th CONGRESS
  2d Session
                                S. 2968

   To amend the Public Health Service Act to address the shortage of 
               influenza vaccine, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 8, 2004

Mr. Reed (for himself, Mr. Kennedy, Mr. Warner, Mr. Daschle, Ms. Snowe, 
Mr. Dodd, Mrs. Clinton, Mr. Dorgan, Mr. Bayh, Mr. Schumer, Mr. Johnson, 
and Mr. Dayton) 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 address the shortage of 
               influenza vaccine, 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 ``Emergency Flu Response Act of 
2004''.

SEC. 2. EMERGENCY FLU RESPONSE.

    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

``SEC. 2141. DEFINITION.

    ``In this subtitle, the term `priority group' means a group 
described as a priority group for vaccination with influenza vaccine in 
recommendations entitled `Interim Influenza Vaccination 
Recommendations--2004-2005 Influenza Season', dated October 5, 2004, or 
any successor to such recommendations issued by the Secretary.

``SEC. 2142. EMERGENCY ACCESS TO INFLUENZA VACCINE.

    ``(a) Declaration of Emergency.--
            ``(1) In general.--Under section 564(b)(1)(C) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-
        3(b)(1)(C)), the Secretary shall immediately declare the 
        shortage of influenza vaccine in the United States for the 
        2004-2005 influenza season to be an emergency justifying an 
        authorization for a product under section 564 of such Act (21 
        U.S.C. 360bbb).
            ``(2) Determination.--For the purpose of making 
        determinations under section 564(b)(1)(C) of such Act to carry 
        out paragraph (1), the Secretary--
                    ``(A) shall deem the shortage to be a public health 
                emergency described in such section; and
                    ``(B) shall deem influenza virus to be a biological 
                agent.
            ``(3) Construction.--Nothing in this subsection shall be 
        considered to invoke the authorities described in section 319, 
        or to limit the ability of the Secretary to invoke such 
        authorities.
    ``(b) Seeking Influenza Vaccine.--The Secretary shall promptly 
consult with the health ministries of Canada, countries that are 
members of the European Union as of January 1, 2003, Japan, and 
Switzerland to assess the availability of influenza vaccine for the 
2004-2005 influenza season that--
            ``(1) has been approved, licensed, or otherwise cleared for 
        marketing by the relevant regulatory agency in such a country; 
        and
            ``(2) is in excess of the needs in such country for the 
        vaccination of persons at high risk for complications from 
        influenza.
    ``(c) Issuance of Authorization.--
            ``(1) In general.--The Secretary shall promptly evaluate 
        available influenza vaccine (as identified under subsection 
        (b)) to determine whether the vaccine meets the criteria for 
        issuance of an authorization under section 564(c) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3(c)).
            ``(2) Criteria.--For the purpose of making determinations 
        under section 564(c) of such Act to carry out paragraph (1), 
        the Secretary--
                    ``(A) shall deem influenza virus to be an agent 
                that can cause a serious or life-threatening disease or 
                condition; and
                    ``(B) shall deem the shortage described in 
                subsection (a)(1) to be sufficient evidence that there 
                is no alternative described in section 564(c)(3).
    ``(d) Vaccine Purchase.--Not later than 30 days after the date of 
enactment of the Emergency Flu Response Act of 2004, the Secretary 
shall purchase, at a reasonable price, available influenza vaccine 
identified under subsection (b) for which the Secretary has issued an 
authorization under section 564(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb-3(c)).
    ``(e) Vaccine Distribution.--Notwithstanding any other provision of 
law, the Secretary shall promptly import and distribute any influenza 
vaccine purchased under subsection (d), giving first priority to 
persons in priority groups.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary 
for fiscal year 2005.

``SEC. 2143. EFFECTIVE RESPONSES TO VACCINE SHORTAGES.

    ``(a) In General.--The Secretary shall award a grant to each State 
to allow such State to develop and implement a plan to respond to the 
shortage of influenza vaccine in the United States for the 2004-2005 
influenza season.
    ``(b) Use of Funds.--A State that receives a grant under this 
section shall use the funds made available through a grant under 
subsection (a) to develop--
            ``(1) a voluntary plan to ensure that the influenza vaccine 
        is, to the maximum extent possible, administered to priority 
        groups;
            ``(2) a system to notify health care providers about 
        revisions in guidelines for administering influenza vaccine;
            ``(3) an awareness campaign to inform the public about 
        recommendations concerning groups that are priority groups for 
        vaccination with influenza vaccine; and
            ``(4) procedures to allow for the voluntary donation of 
        vaccine as described in section 2145.
    ``(c) Amount.--The amount of a grant under subsection (a) shall be 
proportional to the population of the State and the severity of the 
shortage of influenza vaccine in such State, as determined by the 
Secretary.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary 
for fiscal year 2005.

``SEC. 2144. EFFECTIVE MONITORING OF THE NATION'S INFLUENZA VACCINE 
              SUPPLY.

    ``(a) Manufacturers.--Not later than 15 days after the date of 
enactment of the Emergency Flu Response Act of 2004 and every 30 days 
thereafter, any person who manufactures influenza vaccine for 
introduction into interstate commerce shall prepare and submit to the 
Secretary a summary report that lists--
            ``(1) each client, both public and private, who purchased 
        influenza vaccine from the manufacturer during the period 
        covered by the report; and
            ``(2) the number of doses of influenza vaccine sold to each 
        client during the period.
    ``(b) State Public Health Agencies.--To be eligible to receive a 
grant under section 2143(a), a State through its public health agency 
shall, not later than 15 days after the date of enactment of the 
Emergency Flu Response Act of 2004 and every 30 days thereafter, 
prepare and submit to the Secretary a summary report describing--
            ``(1) the number of doses of influenza vaccine available in 
        the State during the period covered by the report;
            ``(2) the number of such doses that were given to each 
        priority group during that period; and
            ``(3) to the extent that such information is readily 
        obtainable by the State, the manner in which such doses were 
        distributed to consumers during such period, such as by 
        distribution through public health agencies or private health 
        care providers.

``SEC. 2145. CLEARINGHOUSES FOR VOLUNTARY DONATION OF INFLUENZA 
              VACCINE.

    ``The Centers for Disease Control and Prevention, and each State 
public health agency described in section 2144(b), shall establish a 
clearinghouse to--
            ``(1) enable persons to voluntarily donate influenza 
        vaccine doses; and
            ``(2) distribute the doses for administration to 
        individuals in priority groups.

``SEC. 2146. PURCHASES OF INFLUENZA VACCINE.

    ``(a) In General.--The Secretary shall establish a program through 
which the Secretary may--
            ``(1) purchase from private employers, vaccine wholesalers, 
        and other appropriate individuals and entities, doses of 
        influenza vaccine that are not needed for the vaccination of 
        priority groups; and
            ``(2) distribute the doses purchased under paragraph (1) 
        for administration to individuals in priority areas.
    ``(b) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary 
for fiscal year 2005.

``SEC. 2147. USE OF INFLUENZA VACCINE.

    ``(a) Executive Branch.--The head of each Executive agency (as 
defined in section 105 of title 5, United States Code) shall ensure 
that any influenza vaccine in the possession of the head of the agency 
shall--
            ``(1) be administered only to employees of the agency who 
        are in priority groups; and
            ``(2) provide to the Secretary any doses of the vaccine 
        that are not needed for the vaccination of individuals in 
        priority groups, so that the Secretary can distribute the doses 
        for administration to individuals in the priority groups.
    ``(b) Legislative Branch.--The Attending Physician of the Capitol 
shall ensure that any influenza vaccine in the possession of the 
Attending Physician shall--
            ``(1) be administered only to employees of the legislative 
        branch of the Federal Government who are in priority groups; 
        and
            ``(2) provide to the Secretary any doses of the vaccine 
        that are not needed for the vaccination of individuals in 
        priority groups, so that the Secretary can distribute the doses 
        for administration to individuals in the priority groups.

``SEC. 2148. ENHANCING EXISTING COUNTERMEASURES AGAINST INFLUENZA.

    ``(a) Authorization to Purchase.--The Secretary may, subject to 
amounts appropriated under subsection (d), purchase at a reasonable 
negotiated price, such additional amounts of any drug approved by the 
Commissioner of Food and Drugs to treat influenza as are determined 
necessary by the Secretary.
    ``(b) Addition to Stockpile.--The Secretary shall include any drug 
purchased under subsection (a) in the stockpile established under 
section 121 of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002.
    ``(c) Increasing the Effectiveness of Existing Vaccine Supplies.--
The Secretary, acting through the Director of the National Institutes 
of Health, shall conduct a clinical trial or trials to determine 
whether influenza vaccine can be diluted and continue to retain its 
effectiveness in preventing influenza in individuals in priority 
groups.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary 
for fiscal year 2005.

``SEC. 2149. NATIONAL QUARANTINE COMPENSATION PROGRAM.

    ``(a) In General.--There is established the National Quarantine 
Compensation Program to be administered by the Secretary under which 
compensation shall be paid to individuals who are subjected to an order 
of quarantine issued by a Federal or State health agency.
    ``(b) Amount.--An individual's compensation under the National 
Quarantine Compensation Program shall be equal to wages lost as a 
result of such individual being subjected to the quarantine.
    ``(c) Appropriations.--There are authorized to be appropriated and 
there are hereby appropriated to carry out subsections (a) and (b) such 
sums as may be necessary.

``SEC. 2150. EMPLOYMENT RIGHTS AND PROTECTIONS RELATING TO FEDERALLY 
              MANDATED HEALTH-RELATED QUARANTINE.

    ``(a) Definitions.--In this section:
            ``(1) Employer.--The term `employer'--
                    ``(A) means any person engaged in commerce or in 
                any industry or activity affecting commerce; and
                    ``(B) includes--
                            ``(i)(I) any person who acts, directly or 
                        indirectly, in the interest of a person 
                        described in subparagraph (A) to any of the 
                        employees of such person; or
                            ``(II) any successor in interest of a 
                        person described in subparagraph (A);
                            ``(ii) any public agency, as defined in 
                        section 3(x) of the Fair Labor Standards Act of 
                        1938 (29 U.S.C. 203(x));
                            ``(iii) the Government Accountability 
                        Office, the Government Printing Office, and the 
                        Library of Congress; and
                            ``(iv) all other legislative branch 
                        entities identified as employing offices in the 
                        Congressional Accountability Act of 1995 (2 
                        U.S.C. 1301 et seq.).
            ``(2) Employment benefits.--The term `employment benefits' 
        means all benefits provided or made available to employees by 
        an employer, including group life insurance, health insurance, 
        disability insurance, sick leave, annual leave, educational 
        benefits, and pensions, regardless of whether such benefits are 
        provided by a practice or written policy of an employer or 
        through an employee benefit plan, as defined in section 3 of 
        the Employee Retirement Income Security Act of 1974 (29 U.S.C. 
        1002).
            ``(3) Secretary.--
                    ``(A) In general.--Except as otherwise provided in 
                subparagraph (B), the term `Secretary' means the 
                Secretary of Labor.
                    ``(B) Exceptions.--In the case of actions brought 
                regarding employees--
                            ``(i) of the Government Accountability 
                        Office, the term `Secretary' means the 
                        Comptroller General of the United States;
                            ``(ii) of the Government Printing Office, 
                        the term `Secretary' means the Public Printer;
                            ``(iii) of the Library of Congress, the 
                        term `Secretary' means the Librarian of 
                        Congress; and
                            ``(iv) of any other legislative branch 
                        employer, the term `Secretary' means the Office 
                        of Compliance.
    ``(b) Employment Rights, Benefits, and Protection From 
Discrimination.--
            ``(1) Restoration to position.--Any individual subjected to 
        an order of quarantine issued by a Federal or State health 
        agency shall be entitled, on return from such quarantine--
                    ``(A) to be restored by the employer of such 
                individual to the position of employment held by the 
                individual when the quarantine of such individual 
                commenced; or
                    ``(B) to be restored to an equivalent position with 
                equivalent employment benefits, pay, and other terms 
                and conditions of employment.
            ``(2) Benefits.--An individual restored to such 
        individual's position, or equivalent position, pursuant to 
        paragraph (1) shall be entitled to the seniority and other 
        rights and benefits that the individual had on the date when 
        the quarantine of such individual commenced, plus the 
        additional seniority and rights and benefits that the 
        individual would have attained had the individual not been 
        subjected to a federally mandated health-related quarantine.
            ``(3) Protection from discrimination.--It shall be unlawful 
        for an employer to discharge or in any other manner 
        discriminate against any individual on the basis of such 
        individual's being, or having been, subjected to a federally 
        mandated health-related quarantine.
    ``(c) Investigative Authority; Enforcement.--
            ``(1) In general.--The Secretary shall ensure compliance 
        with the provisions of subsection (b) and enforce violations of 
        subsection (b).
            ``(2) Same authorities.--In order to carry out paragraph 
        (1), the Secretary shall have the same authorities as provided 
        to the Secretary under sections 106 and 107 of the Family and 
        Medical Leave Act of 1993 (29 U.S.C. 209 and 210) to ensure 
        compliance with and enforce violations of the Family and 
        Medical Leave Act of 1993.
    ``(d) State and Local Laws.--Nothing in this section shall be 
construed to supersede any provision of any State or local law that 
provides greater rights than the rights established under this 
section.''.

``SEC. 2151. ASSURING THAT INDIVIDUALS IN PRIORITY GROUPS RECEIVE 
              VACCINES.

    ``(a) Determinations.--Not later than 30 days after the date of 
enactment of the Emergency Flu Response Act of 2004, and every 30 days 
thereafter, the Secretary shall review the effectiveness of measures 
taken under sections 2142 through 2147 and determine whether the 
measures have ensured the distribution of influenza vaccine for 
administration to individuals in priority groups. If the Secretary 
determines that the measures have not ensured that distribution, the 
Secretary--
            ``(1) may take the actions described in subsection (b) if 
        the Secretary determines that such actions are needed to 
        protect the public health; and
            ``(2) shall notify the appropriate committees of Congress 
        of such determination.
    ``(b) Assuring the Individuals in Priority Groups Receive 
Vaccines.--On making the determination described in subsection (a), the 
Secretary may require that a person, not including a person that is a 
manufacturer of influenza vaccine, who possesses influenza vaccine sell 
such person's supply of the influenza vaccine to the Federal 
Government, as an exercise of the Federal Government's power to take 
private property for public use, for just compensation.
    ``(c) Prioritization.--The Secretary shall distribute the doses of 
influenza vaccine obtained under subsection (b) in a manner determined 
appropriate by the Secretary to ensure that such vaccine is 
administered to individuals in priority groups.''.
                                 <all>