[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 2456 Introduced in Senate (IS)]
110th CONGRESS
1st Session
S. 2456
To amend the Public Health Service Act to improve and secure an
adequate supply of influenza vaccine.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 12, 2007
Mr. Reid (for Mrs. Clinton (for herself and Mr. Roberts)) 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 improve and secure an
adequate supply of influenza vaccine.
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 ``Influenza Vaccine Security Act of
2007''.
TITLE I--MARKET GUARANTEES
SEC. 101. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.
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 Security
``SEC. 2141. ESTABLISHMENT OF AN INFLUENZA VACCINE TARGET AND
STOCKPILE.
``(a) Annual Target.--The Secretary, in consultation with the
Advisory Committee on Immunization Practices to the Centers for Disease
Control and Prevention (referred to in this subtitle as the `Advisory
Committee'), shall determine an annual production target for influenza
vaccine, based on the recommendations of the Advisory Committee. Based
on such target, the Secretary, acting through the Centers for Disease
Control and Prevention, shall coordinate with the private market to
encourage the production of such vaccine in amounts that will meet the
annual target.
``(b) Stockpile.--Prior to the start of each annual influenza
season (as determined by the Secretary), the Secretary is authorized to
purchase and store from multiple manufacturers an amount not to exceed
10 percent of the total amount of influenza vaccine, including one or
more active vaccine antigen ingredients in bulk or filled form, that is
designated for production by the Advisory Committee for placement in
the strategic national stockpile under section 121 of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002
(referred to in this subtitle as the `strategic national stockpile').
Such vaccine shall be held in reserve to be used in the event of a
vaccine shortage in a given influenza season. The Secretary shall
coordinate with the manufacturers involved to ensure that reserving
amounts of vaccine for the stockpile does not interfere with the early
season delivery or early season administration of vaccine to high
priority populations (as defined by the Advisory Committee on
Immunization Practices and the Centers for Disease Control and
Prevention) (referred to in this subtitle as `high priority
populations').
``SEC. 2142. VACCINE BUYBACK PROGRAM.
``(a) In General.--The Secretary shall establish an influenza
vaccine buyback protocol under which the Secretary may enter into
buyback contracts with manufacturers of influenza vaccine to purchase
such manufacturers' excess stocks of influenza vaccine so long as such
vaccine has been manufactured in accordance with the recommendations of
the Advisory Committee for the production of seasonal influenza
vaccine.
``(b) Manufacturers.--The Secretary shall have the discretion to
award buyback contracts under subsection (a) to several influenza
vaccine manufacturers in a manner consistent with the goal of providing
stability in the influenza vaccine market, as long as the Federal
Government purchases not more than 50 percent of the excess influenza
vaccine stock of any single manufacturer at market price.
``(c) Cooperation With Manufacturers, Distributors, and
Wholesalers.--As a condition of participation in the buyback program
under this section, the Director of the Centers for Disease Control and
Prevention shall work in cooperation with influenza vaccine
manufacturers and wholesalers and distributors within the chain of
custody from factory to health care institution or health care
providers to share pertinent information that will allow for the
tracking of influenza vaccine, maximize the delivery and availability
of influenza vaccines to high priority populations, and ensure that
influenza vaccine is delivered on an equitable basis, particularly in
times of vaccine shortages.
``(d) Confidentiality.--The information submitted to the Centers
for Disease Control and Prevention or its contractors, if any, under
subsections (c) and (d) shall remain confidential in accordance with
the exception from the public disclosure of trade secrets, commercial
or financial information, and information obtained from an individual
that is privileged and confidential, as provided for in section
552(b)(4) of title 5, United States Code, and subject to the penalties
and exceptions under sections 1832 and 1833 of title 18, United States
Code, relating to the protection and theft of trade secrets, and
subject to privacy protections that are consistent with the regulations
promulgated under section 264(c) of the Health Insurance Portability
and Accountability Act of 1996. None of such information provided by a
manufacturer, wholesaler, or distributor shall be disclosed without its
consent to another manufacturer, wholesaler, or distributor, or shall
be used in any manner to give a manufacturer, wholesaler, or
distributor a proprietary advantage over its competitors.
``(e) Ability To Negotiate.--The Secretary shall have the ability
to negotiate, on a case-by-case basis, the submission of information
under subsection (c), as long as the information provided will achieve
the goals of tracking of the influenza vaccine, maximizing the delivery
and availability of influenza vaccines to high priority populations,
and ensuring that influenza vaccine is delivered on an equitable
geographical basis, particularly in times of vaccine shortages.
``(f) Notice.--
``(1) In general.--For purposes of maintaining and
administering the supply of vaccines described under subsection
(a), the Secretary shall by contract require that a
manufacturer of a vaccine included in such supply provide not
less than 12 months notice to the Secretary of a purposeful
discontinuance of the manufacture of such vaccine by the
manufacture of the vaccine.
``(2) Reduction of period of notice.--The notification
period required under paragraph (1) shall not apply in a case
in which vaccine production is interrupted because of
unforeseen manufacturing concerns.
``(g) Use of Vaccine Post Buyback.--Following the buyback of
vaccine under this section, the Secretary shall direct that any vaccine
purchased in such buyback be used for the following activities:
``(1) Use in late-season mass vaccination exercises
conducted in coordination with Federal, State or local agencies
engaged in emergency preparedness and bioterrorism preparedness
activities. Such exercises should be carried out in partnership
with voluntary organizations working to improve emergency
preparedness and bioterrorism preparedness.
``(2) Promoting and carrying out late-season vaccination
through the Indian Health Service, the Public Health Service,
the Department of Veterans Affairs, or through other federally
funded health care providers, such as community health centers
and rural health clinics.
``(3) Other activities approved by the Secretary.
``SEC. 2143. CRITICAL SUPPLY PURCHASE PROGRAM.
``(a) In General.--The Secretary shall increase the amount of
antiviral medications, N-95 respirator masks, and other protections and
treatments, as determined necessary by the Secretary as they become
available, to treat and prevent pandemic influenza, in the strategic
national stockpile. In increasing such amounts, the Secretary shall
consult with the Director of the Centers for Disease Control and
Prevention and the Assistant Secretary for Preparedness and Response,
to determine the amounts that are necessary to provide adequate
protection to not less than the number of individual who respond to an
influenza epidemic.
``(b) Pediatric Programs.--The Secretary is encouraged to consult
with all relevant Federal agencies and the private sector to develop
and approve N-95 respirators and other protections and treatments, as
determined necessary by the Secretary, to treat and prevent pandemic
influenza, and shall ensure that such products are represented in
adequate amounts in the strategic national stockpile to provide
adequate protection to pediatric populations in the United States.
``SEC. 2144. AUTHORIZATION OF APPROPRIATIONS.
``There are authorized to be appropriated such sums as may be
necessary to carry out this subtitle in each of fiscal years 2008
through 2012.''.
TITLE II--FOOD AND DRUG ADMINISTRATION ASSISTANCE TO MANUFACTURERS
SEC. 201. AMENDMENT TO THE FOOD, DRUG, AND COSMETIC ACT.
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
391 et seq.) is amended by adding at the end the following:
``SEC. 909. PROVISIONS RELATED TO THE EMERGENCY ACQUISITION OF
VACCINES.
``(a) In General.--
``(1) Increased communication.--The Food and Drug
Administration shall carry out activities to increase
communication between the agency and the scientific community
regarding vaccine development and regulation, including
participation in conferences on the science related to
infectious diseases, influenza, biologic manufacturing, and
other issues as determined appropriate by the Director of the
Center for Biologics Evaluation and Research.
``(2) Regulatory roadmap.--The Commissioner, in
consultation with the Director of the Centers for Disease
Control and Prevention, the Secretary, and other agencies or
participants as determined appropriate by the Secretary, shall
develop a regulatory roadmap to address the following issues
surrounding emergency use authorization of influenza vaccine,
as determined by the Secretary during a public health emergency
involving an actual or imminent outbreak of naturally occurring
or engineered seasonal influenza:
``(A) Policies for the emergency use authorization
of influenza vaccine that is produced and sold in other
countries so that such vaccine may be imported into the
United States by the United States Government during a
vaccine shortage.
``(B) Policies for the facilitation of the
distribution of any such vaccine imported into the
United States during a vaccine shortage, including the
interstate transportation, allocation and equitable
distribution of vaccine among high priority populations
(as defined by the Advisory Committee on Immunization
Practices and the Centers for Disease Control and
Prevention) during an emergency use situation.
``(C) Policies for the communication and
coordination of a response to an emergency use
authorization with State and local health departments,
including guidelines for notification of such entities
in such situations.
``(D) Policies for the emergency use authorization
of vaccines that are in clinical development in both
the United States and other countries, including
clarification of IND protocols for such vaccines,
particularly those using new vaccine development
technologies.
``(3) Consultation.--In developing the roadmap under
paragraph (2), the Commissioner shall solicit input from
private and nonprofit stakeholders, including State and local
health officials, and such input shall include recommendations
for developing emergency use authorization guidelines that
maintain the scientific and regulatory standards of the Food
and Drug Administration.
``(4) Standing orders.--
``(A) Development.--The Secretary shall direct the
Centers for Disease Control and Prevention, in
conjunction with State and local health departments and
representatives of State medical boards and nursing
examiners, to develop and publish a model standing
order that will, at a minimum, address the need for
standing orders to administer influenza vaccine in
hospitals, community health centers, nursing homes, and
other assisted living facilities, and by home health
care providers. The Centers for Disease Control and
Prevention is encouraged to expand such a model
standing order to take into account--
``(i) the administration of other Medicare
covered vaccines; and
``(ii) the delivery of influenza vaccine to
patients in children's hospitals or other
institutions serving the long-term care needs
of a pediatric population, including those in a
non-clinical setting.
``(B) Implementation.--Not less than 1 year after
the publication of the standing order under paragraph
(A), States shall be required to implement such
standing order in order to be eligible to receive
grants under this Act.
``(C) Rule of construction.--Nothing in this
paragraph shall be construed as precluding the
application of State laws, so long as such laws do not
restrict the implementation of this requirements of the
Influenza Vaccine Security Act of 2007 (and the
amendments made by such Act).
``(b) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $5,000,000 for fiscal year
2008, and such sums as may be necessary for each of fiscal years 2009
through 2012, to be made available to the Food and Drug Administration
to provide the technical assistance and take advantage of the training
opportunities as designated in this section.''.
TITLE III--VACCINE EDUCATION, OUTREACH, AND COORDINATION
SEC. 301. AUTHORITY OF THE NATIONAL CENTER FOR IMMUNIZATION AND
RESPIRATORY DISEASES FOR COORDINATION, EDUCATION,
OUTREACH, AND COMMUNICATION ACROSS HHS.
Section 2102 of the Public Health Service Act (42 U.S.C. 300aa-2)
is amended--
(1) in subsection (a), by adding at the end the following:
``(10) Coordination of support.--The Director of the
Center, in consultation with the Director of the National
Institute for Allergy and Infectious Disease, shall--
``(A) coordinate efforts in regard to all influenza
vaccine education, outreach, surveillance, and research
activities within the Department in support of the goal
of--
``(i) increasing overall influenza
vaccination rates in the United States,
particularly those of high priority populations
(as defined by the Advisory Committee on
Immunization Practices and the Centers for
Disease Control and Prevention) and health care
providers;
``(ii) increasing vaccination rates among
medically underserved populations with low
vaccination rates; and
``(iii) any other vaccine promotion
activities as directed by the Secretary;
``(B) coordinate educational efforts under this
paragraph with the National Vaccine Program Office,
State and local health departments, the National
Institutes of Health, and all other relevant Federal
and other entities as designated by the Director; and
``(C) provide an annual report to Congress on the
progress being made toward the goals described in
subparagraph (A).''; and
(2) by adding at the end the following:
``(c) Appropriations for Coordination of Influenza Vaccine Outreach
Activities.--There is authorized to be appropriated to carry out
activities under subsection (a)(10), $2,000,000 for each of fiscal
years 2008 through 2012.''.
TITLE IV--INCREASED INFLUENZA VACCINE AND OUTBREAK SURVEILLANCE
ACTIVITIES
SEC. 401. TRACKING NETWORK AND DEMONSTRATION GRANTS.
Title III of the Public Health Service Act is amended by inserting
after section 319B (42 U.S.C. 247d-2) the following:
``SEC. 319B-1. TRACKING NETWORK AND DEMONSTRATION GRANTS.
``(a) Tracking System.--
``(1) Establishment.--Not later than 2 years after the date
of enactment of this section, the Director of the Centers for
Disease Control and Prevention, in conjunction with State and
local public health officials and health provider and nonprofit
organizations, shall establish an electronic tracking system
through which the Director and such officials can determine the
amount of influenza vaccine within a 24-hour window that is
available for distribution to patients, as well as the need for
such vaccine on a county-by-county basis, and the progress of
vaccine delivery and distribution efforts at the State and
local level.
``(2) Estimates.--The tracking system established under
paragraph (1) shall collect estimates of the size of high
priority populations (as defined by the Advisory Committee on
Immunization Practices and the Centers for Disease Control and
Prevention) (referred to in this section as `high priority
populations') in each county in the United States, so as to
better determine where influenza vaccine resources may need to
be directed in the case of an emergency.
``(3) Provision of information.--To be eligible to
participate in buyback programs the vaccine manufacturer shall
provide information to the tracking system as the Director of
the Centers for Disease Control and Prevention determines
appropriate in accordance with subtitle 3 of title XXI.
``(4) Confidentiality.--The information submitted to the
Secretary (or a contractors, if any) under this section or
under any other section of this Act related to vaccine
distribution information shall remain confidential in
accordance with the exception from the public disclosure of
trade secrets, commercial or financial information, and
information obtained from an individual that is privileged and
confidential, as provided for in section 552(b)(4) of title 5,
United States Code, and subject to the penalties and exceptions
under sections 1832 and 1833 of title 18, United States Code,
relating to the protection and theft of trade secrets, and
subject to privacy protections that are consistent with the
regulations promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996. None of
such information provided by a manufacturer, wholesaler, or
distributor shall be disclosed without its consent to another
manufacturer, wholesaler, or distributor, or shall be used in
any manner to give a manufacturer, wholesaler, or distributor a
proprietary advantage.
``(5) Guidelines.--The Secretary, in order to maintain the
confidentiality of relevant information and ensure that none of
the information contained in the systems involved may be used
to provide proprietary advantage within the vaccine market,
while allowing State, local, and tribal health officials access
to such information to maximize the delivery and availability
of vaccines to high priority populations, during times of
influenza pandemics, vaccine shortages, and supply disruptions,
in consultation with manufacturers, distributors, wholesalers
and State, local, and tribal health departments, shall develop
guidelines permitting the Department of Health and Human
Services to carry out paragraphs (1) and (2) and (3).
``(b) Expansion of Current Systems and Activities.--
``(1) Surveillance system.--Not later than 4 years after
the date of enactment of this section, the Director of the
Centers for Disease Control and Prevention shall upgrade and
enhance the influenza surveillance system of the Centers for
Disease Control and Prevention to report influenza data from
State and local health departments into the tracking system
established under subsection (a)(1).
``(2) Educational materials.--The tracking system shall
contain information to assist users in accessing influenza
education, outreach, and communications tools, such as those
developed and financed under the Influenza Vaccine Security Act
of 2007 (and the amendments made by such Act).
``(c) Demonstration Grants.--
``(1) In general.--The Director of the Centers for Disease
Control and Prevention shall award demonstration grants to
State and local health departments to enable such departments
to enter into contract with hospitals, community health
centers, long-term care facilities, physicians' offices, and
health care facilities operated or funded by such departments
to assist such department and entities in upgrading their
information technology, infrastructure, and workforce in a
manner that will allow such departments and entities to improve
their ability to report and track influenza vaccine
dissemination.
``(2) Priority.--In awarding grants under paragraph (1),
priority shall be given to departments and entities that serve
high priority populations in medically underserved areas.
``(d) Authorization of Appropriations.--There are authorized to be
appropriated--
``(1) to carry out subsection (a), $100,000,000 for each of
fiscal years 2008 through 2012, of which $500,000 for each
fiscal year shall be made available to implement subsection
(b)(3); and
``(2) to carry out subsection (c), $100,000,000 for each of
fiscal years 2008 through 2012.''.
TITLE V--FLU VACCINE OUTREACH AND EDUCATION
SEC. 501. EDUCATIONAL EFFORTS AND GRANTS.
Title III of the Public Health Service Act is amended by inserting
after section 319B-1 (as added by section 401) the following:
``SEC. 319B-2. IMMUNIZATION EDUCATIONAL EFFORTS AND GRANTS.
``(a) In General.--The Director of the Centers for Disease Control
and Prevention, in conjunction with State and local health departments,
shall revise and expand the influenza-related educational materials to
the Centers for Disease Control and Prevention, and facilitate the use
of such materials by health care providers and patients. The Director
is authorized to coordinate such educational efforts with nonprofit
provider and patient advocacy groups.
``(b) Influenza Vaccine Education and Outreach.--
``(1) In general.--In order to achieve an optimal balance
in the influenza vaccine market, and to ensure that the
recommendations of the Advisory Committee on Immunization
Practices to the Centers for Disease Control and Prevention for
vaccine administration are carried out to the maximum extent
possible, the Director of the Centers for Disease Control and
Prevention, in conjunction with State and local health
departments, shall carry out influenza immunization education
and outreach activities that target physicians and other health
care providers, health insurance providers, health care
institutions and patients, particularly those in high priority
populations (as defined by the Advisory Committee on
Immunization Practices and the Centers for Disease Control and
Prevention) (referred to in this section as `high priority
populations').
``(2) Types of activities.--The education and outreach
activities under paragraph (1) shall include--
``(A) activities to encourage voluntary
participation in influenza vaccination programs, with
the goal of increasing overall influenza vaccination
rates in the United States, achieving full influenza
vaccination of all high priority populations, and full
use of each season's influenza vaccine supply and late
season vaccination;
``(B) the provision of information on influenza
prevention, including to medically underserved
communities with low vaccination rates;
``(C) activities to increase the number of
healthcare providers who receive influenza vaccines
each year; and
``(D) other influenza educational efforts
determined appropriate by the Director.
``(c) Grants.--The Director of the Centers for Disease Control and
Prevention may award grants to State and local health departments to
carry out activities to encourage individuals, particularly those from
high priority populations, to seek out influenza vaccinations.
``(d) Collaboration.--State and local health departments that
receive grants under subsection (b) are encouraged to collaborate on
projects with physicians and other health care providers, health
insurance providers, health care institutions, and groups representing
high priority populations.
``(e) Authorization of Appropriations.--In addition to any amounts
otherwise available through the Secretary for influenza outreach and
education, there is authorized to be appropriated to carry out this
section, $10,000,000 for each of fiscal years 2008 through 2012.''.
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