[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.