```

[House Report 107-168]
[From the U.S. Government Publishing Office]

107th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                    107-168

======================================================================

 
                  FLU VACCINE AVAILABILITY ACT OF 2001

                                _______
                                

 July 26, 2001.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Tauzin, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 943]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 943) to amend the Public Health Service Act with 
respect to the availability of influenza vaccine through the 
program under section 317 of such Act, having considered the 
same, report favorably thereon with an amendment and recommend 
that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     1
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Hearings.........................................................     3
Committee Consideration..........................................     4
Committee Votes..................................................     4
Committee Oversight Findings.....................................     4
Statement of General Performance Goals and Objectives............     4
New Budget Authority, Entitlement Authority, and Tax Expenditures     4
Committee Cost Estimate..........................................     4
Congressional Budget Office Estimate.............................     4
Federal Mandates Statement.......................................     6
Advisory Committee Statement.....................................     6
Constitutional Authority Statement...............................     6
Applicability to Legislative Branch..............................     6
Section-by-Section Analysis of the Legislation...................     6
Changes in Existing Law Made by the Bill, as Reported............     6

                               Amendment

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Flu Vaccine Availability Act of 
2001''.

SEC. 2. AMENDMENT TO PUBLIC HEALTH SERVICE ACT REGARDING AVAILABILITY 
                    OF INFLUENZA VACCINE.

  Section 317(j) of the Public Health Service Act (42 U.S.C. 247b(j)) 
is amended by adding at the end the following paragraph:
  ``(3)(A) For the purpose of carrying out activities relating to 
influenza vaccine under the immunization program under this subsection, 
there are authorized to be appropriated such sums as may be necessary 
for each of the fiscal years 2002 and 2003. Such authorization is in 
addition to amounts available under paragraphs (1) and (2) for such 
purpose.
  ``(B) The authorization of appropriations established in subparagraph 
(A) is not effective for a fiscal year unless the total amount 
appropriated under paragraphs (1) and (2) for the fiscal year is not 
less than such total for fiscal year 2000.
  ``(C) The purposes for which amounts appropriated under subparagraph 
(A) are available to the Secretary include providing for improved State 
and local infrastructure for influenza immunizations under this 
subsection in accordance with the following:
          ``(i) Increasing influenza immunization rates in populations 
        considered by the Secretary to be high risk for influenza-
        related complications and in their contacts.
          ``(ii) Recommending that health care providers actively 
        target influenza vaccine available in September, October, and 
        November to individuals at increased risk for influenza-related 
        complications and to their contacts.
          ``(iii) Providing for the continued availability of influenza 
        immunizations through December of such year, and for additional 
        periods to the extent that influenza vaccine remains available.
          ``(iv) Encouraging States as appropriate to develop 
        contingency plans (including plans for public and professional 
        educational activities) for maximizing influenza immunizations 
        for high-risk populations in the event of a delay or shortage 
        of influenza vaccine.
  ``(D) The Secretary shall submit to the Committee on Energy and 
Commerce in the House of Representatives, and the Committee on Health, 
Education, Labor, and Pensions in the Senate, periodic reports Congress 
describing the activities of the Secretary under this subsection 
regarding influenza vaccine. The first such report shall be submitted 
not later than June 6, 2002, the second report shall be submitted not 
later than June 6, 2003, and subsequent reports shall be submitted 
biennially thereafter.''.

                          Purpose and Summary

    The purpose of H.R. 943, the Flu Vaccine Availability Act 
of 2001, as amended, is to ensure that flu vaccines are 
received by the States, and distributed to qualifying health 
care providers for the immunization of children, adolescents, 
and adults in accordance with established guidelines of the 
immunization program. This legislation also expresses the sense 
of the House of Representatives that oversight hearings should 
be convened immediately to determine: (1) the course of action 
followed by distributors of influenza vaccine during this 
influenza season; (2) whether or not such distributors put 
profit ahead of the health and well-being of the American 
people; and (3) whether it is necessary to take additional 
measures to ensure the safe, adequate, and timely supply of 
influenza vaccines in the future.

                  Background and Need for Legislation

    Epidemics of influenza typically occur during the winter 
months and, according to the most recent report of the Advisory 
Committee on Immunization Practices (ACIP), are responsible for 
approximately 20,000 deaths per year in the United States. 
Rates of infection are highest among children, but rates of 
serious illness and death are highest among people over age 65 
and persons of any age who have medical conditions that place 
them at increased risk for complications from influenza.
    On July 14, 2000, the Centers for Disease Control reported 
a substantial delay in the supply of the influenza vaccine for 
the 2000-01 season and the possibility of a vaccine shortage. 
The optimal time to administer influenza vaccine is October 
through mid-November, but a substantial amount of the flu 
vaccine was distributed late in the season. At that time, much 
of the limited vaccine supply was diverted from physicians and 
hospitals to non-professional distributors who distributed the 
vaccine on a first-come, first-serve basis, regardless of risk, 
thereby depriving patients most in need from receiving the 
vaccine.
    While a resolution of manufacturing problems and improved 
yields of the vaccine averted a serious crisis, recent studies 
have indicated that a similar crisis may arise during the 2001-
02 influenza season. In the Centers for Disease Control's 
Morbidity and Mortality Weekly Report (MMWR) dated July 13, 
2001, vaccine distribution for the 2001-02 influenza season 
suggest that 49.8 million doses will be available for delivery 
by the end of October 2001--approximately 26 million fewer 
doses of the vaccine than were available by the end of October 
1999 (75.8 million doses). However, manufacturers also project 
distribution of 27.3 million doses in November and December, 
bringing the cumulative projected total to 77.1 million doses, 
which is greater than the 70.4 million doses distributed in 
2000 and comparable with the 76.8 million doses distributed in 
1999.
    Because of the potential for another influenza vaccine 
delay, the ACIP has developed supplemental recommendations. The 
goals of the recommendations are (1) to prioritize and phase in 
using vaccine for the 2001-02 influenza season to ensure that 
persons at greatest risk forsevere influenza and its 
complications and their health-care providers receive vaccine early in 
the influenza season, and (2) to increase overall protection of those 
at greatest risk for severe influenza and its complications.
    Steps must be taken to ensure the safe, adequate, and 
timely supply of vaccines in the future. H.R. 943 will help 
ensure that such a shortage, were it to happen again, would be 
alleviated by proper planning by CDC, the States, and local 
administrators of the vaccines. The Flu Vaccine Availability 
Act of 2001 helps ensure that influenza vaccine shortages do 
not jeopardize the health of thousands of Americans in future 
flu seasons. The bill would authorize funding under the Public 
Health Service Act immunization program for the distribution of 
influenza vaccine to qualifying health care providers, 
including physicians. Enactment of this measure would help 
prevent a recurrence of the distribution problems that took 
place during the 2000-01 flu season.

                                Hearings

    The Subcommittee on Health held a hearing on H.R. 943 on 
June 27, 2001. The witness testifying on the bill was William 
J. Hall, M.D., President, American College of Physicians--
American Society of Internal Medicine.

                        Committee Consideration

    On Wednesday, July 11, 2001, the Subcommittee on Health met 
in open markup session and approved H.R. 943 for Full Committee 
consideration, as amended, by a voice vote, a quorum being 
present. On Wednesday, July 18, 2001, the Full Committee met in 
open markup session and ordered H.R. 943 favorably reported to 
the House, as amended, by a voice vote, a quorum being present.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 943 reported. A motion by Mr. Tauzin to order H.R. 943 
reported to the House, as amended, was agreed to by a voice 
vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee held a legislative 
hearing and made findings that are reflected in this report.

         Statement of General Performance Goals and Objectives

    The goal of H.R. 943 is to ensure the safe, adequate, and 
timely supply of the influenza vaccine to those who are at 
greatest risk of influenza and its complications.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
943, the Flu Vaccine Availability Act of 2001, would result in 
no new or increased budget authority, entitlement authority, or 
tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, July 24, 2001.
Hon. W.J. ``Billy'' Tauzin,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed estimate of H.R. 943, the Flu Vaccine 
Availability Act of 2001, as ordered reported by the Committee 
on Energy and Commerce on July 18, 2001.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Jeanne De Sa.
            Sincerely,
                                          Barry B. Anderson
                                    (For Dan L. Crippen, Director).
    Enclosure.

H.R. 943--Flu Vaccine Availability Act of 2001

    H.R. 943 would permit the Centers for Disease Control and 
Prevention (CDC) to conduct activities to enhance influenza 
vaccination efforts by state and local governments and would 
authorize the appropriation of such sums as necessary in fiscal 
years 2002 and 2003 for that purpose. Those activities would 
focus on increasing influenza vaccination rates among adults, 
particularly high-risk populations and health care workers. The 
bill also would provide for the continued availability of the 
vaccine, and encourage states to develop contingency plans in 
the event of a vaccine shortage. Because CDC is authorized to 
conduct those activities under current law, CBO estimates the 
bill would not have a significant budgetary effect.
    Section 317 of the Public Health Service Act provides an 
indefinite authorization of such sums as necessary for CDC to 
provide grants to state and local governments for the 
immunization of children, adolescents, and adults against 
vaccine-preventable diseases. Some grant awards target the 
improvement of vaccine delivery systems; others assist grantees 
in conducting immunization programs and purchasing vaccines.
    In fiscal year 2001, CDC awarded $159 million in grants to 
states and local governments for the improvement of operations 
and infrastructure of vaccine programs, most of which support 
activities related to childhood vaccinations. Only a few of the 
grantees target more than 10 percent of their fiscal year 2001 
grant funds toward adult immunization efforts. Under existing 
authority, CDC could provide grant funds for purposes outlined 
in the bill. CDC has also recently recommended that state and 
local governments develop contingency plans in the event of a 
vaccine shortage.
    The legislation would not affect direct spending or 
receipts; therefore, pay-as-you-go procedures would not apply. 
H.R. 943 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act and 
would impose no costs on the budgets of state, local, or tribal 
governments.
    The CBO staff contact is Jeanne De Sa. This estimate was 
approved by Peter H. Fontaine, Deputy Assistant Director for 
Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation

Section 1. Short title

    This Act may be cited as the ``Flu Vaccine Availability Act 
of 2001.''

Section 2. Amendment to Public Health Service Act regarding 
        availability of influenza vaccine

    Section 2 provides such funds as may be necessary for 
providing for improved State and local infrastructure for 
influenza immunizations in accordance with the following: (1) 
assuring a priority system is intact for serving high-risk 
populations, (2) increasing public awareness on the 
effectiveness of the influenza vaccine late in the flu season, 
and (3) encouraging States to develop contingency plans for 
maximizing influenza immunizations in the event of a delay or 
shortage of influenza vaccine. This section also stipulates 
that the Secretary of Health and Human Services shall submit to 
the Committee on Energy and Commerce in the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions in the Senate, periodic reports describing the 
activities of the Secretary regarding influenza vaccine.

         Changes in Existing Law Made by the Bill, as Reported

    In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italic and existing law in which no change is 
proposed is shown in roman):

              SECTION 317 OF THE PUBLIC HEALTH SERVICE ACT

             project grants for preventive health services

    Sec. 317. (a) * * *

           *       *       *       *       *       *       *

    (j)(1) * * *

           *       *       *       *       *       *       *

    (3)(A) For the purpose of carrying out activities relating 
to influenza vaccine under the immunization program under this 
subsection, there are authorized to be appropriated such sums 
as may be necessary for each of the fiscal years 2002 and 2003. 
Such authorization is in addition to amounts available under 
paragraphs (1) and (2) for such purpose.
    (B) The authorization of appropriations established in 
subparagraph (A) is not effective for a fiscal year unless the 
total amount appropriated under paragraphs (1) and (2) for the 
fiscal year is not less than such total for fiscal year 2000.
    (C) The purposes for which amounts appropriated under 
subparagraph (A) are available to the Secretary include 
providing for improved State and local infrastructure for 
influenza immunizations under this subsection in accordance 
with the following:
          (i) Increasing influenza immunization rates in 
        populations considered by the Secretary to be high risk 
        for influenza-related complications and in their 
        contacts.
          (ii) Recommending that health care providers actively 
        target influenza vaccine available in September, 
        October, and November to individuals at increased risk 
        for influenza-related complications and to their 
        contacts.
          (iii) Providing for the continued availability of 
        influenza immunizations through December of such year, 
        and for additional periods to the extent that influenza 
        vaccine remains available.
          (iv) Encouraging States as appropriate to develop 
        contingency plans (including plans for public and 
        professional educational activities) for maximizing 
        influenza immunizations for high-risk populations in 
        the event of a delay or shortage of influenza vaccine.
    (D) The Secretary shall submit to the Committee on Energy 
and Commerce in the House of Representatives, and the Committee 
on Health, Education, Labor, and Pensions in the Senate, 
periodic reports Congress describing the activities of the 
Secretary under this subsection regarding influenza vaccine. 
The first such report shall be submitted not later than June 6, 
2002, the second report shall be submitted not later than June 
6, 2003, and subsequent reports shall be submitted biennially 
thereafter.

                                

```