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                                               February 2, 2009



                        Congressional Research Service
                                       Report RS22576
      Pandemic Influenza: Appropriations for Public Health
                   Preparedness and Response
                              Sarah A. Lister, Domestic Social Policy Division

                                              November 27, 2007

Abstract. The spread of H5N1 avian influenza ("flu"), and the human deaths it has caused, raise concern that
the virus could morph and cause a global human pandemic. Congress has provided specific funding for pandemic
flu preparedness since FY2004, including $6.1 billion in emergency supplemental appropriations for FY2006.
These funds bolster related activities to prepare for public health threats, and to control seasonal flu. This re-
port discusses appropriations for pandemic flu, primarily to the Department of Health and Human Services (HHS).
                                                                                                                        Order Code RS22576
                                                                                                                  Updated November 27, 2007




                                               Pandemic Influenza: Appropriations for
                                              Public Health Preparedness and Response
                                                                           Sarah A. Lister
                                                            Specialist in Public Health and Epidemiology
                                                                  Domestic Social Policy Division

                                        Summary

                                                  The spread of H5N1 avian influenza ("flu"), and the human deaths it has caused,
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                                            raise concern that the virus could morph and cause a global human pandemic. Congress
                                            has provided specific funding for pandemic flu preparedness since FY2004, including
                                            $6.1 billion in emergency supplemental appropriations for FY2006. These funds bolster
                                            related activities to prepare for public health threats, and to control seasonal flu. This
                                            report discusses appropriations for pandemic flu, primarily to the Department of Health
                                            and Human Services (HHS), and will be updated as needed.

                                        Background
                                              In 1997, a new avian (bird) flu virus (H5N1) emerged in Asia and killed six people.
                                        It has since spread to Europe and Africa. The virus has infected more than 330 people,
                                        killing more than half of them. Health officials are concerned that it could change
                                        sufficiently to cause a global human pandemic. Beginning in FY2004, Congress has
                                        provided funding specifically for pandemic flu preparedness, through both regular and
                                        emergency supplemental appropriations. This report describes federal funding for
                                        pandemic flu, primarily to the Department of Health and Human Services (HHS). Federal
                                        funding to control the disease in birds is generally provided to the U.S. Department of
                                        Agriculture (USDA) for activities involving commercial poultry, and to the Department
                                        of the Interior for activities involving wildlife. The Departments of Homeland Security,
                                        Defense, State, and Veterans Affairs, and the U.S. Agency for International Development
                                        (USAID), have also received funds for global avian flu control.1

                                             It is difficult to track federal funding for flu preparedness, for several reasons. First,
                                        funds designated specifically for pandemic flu do not reflect the sum of all relevant
                                        activities. For example, programs to improve health surveillance in general, or to
                                        streamline federal disaster response, are important for pandemic preparedness. Also, the


                                        1
                                           For more information, see CRS Reports on appropriations at [http://apps.crs.gov/cli
                                        /level_2.aspx?PRDS_CLI_ITEM_ID=73], and CRS Report RL33145, Pandemic Influenza:
                                        Domestic Preparedness Efforts, by Sarah A. Lister.
                                                                                     CRS-2

                                        President has called on all federal agencies to develop continuity plans for a flu pandemic,
                                        activities that are typically funded through general administrative accounts. Second,
                                        certain activities (e.g., the expansion of vaccine production capacity) address preparedness
                                        for both seasonal and pandemic flu, and may not be designated as pandemic spending,
                                        despite their relevance. Finally, federal agencies may not prepare budget information,
                                        such as the presentation of base funding or annual increases, in a consistent fashion.

                                            This report provides information on appropriations, primarily to HHS, that the
                                        Congress has specifically designated for pandemic flu preparedness. Appropriated
                                        amounts are presented in Tables 1 and 2. Pandemic flu funding for HHS has generally
                                        been provided in the Public Health and Social Services Emergency Fund (PHSSEF), an
                                        account intended for one-time or short-term activities. This report will be updated.

                                        History of Recent Appropriations
                                             FY2004. In February 2003, the Administration requested $100 million in FY2004
                                        appropriations for activities to ensure an adequate supply of vaccine in the event of a
                                        pandemic.2 In P.L. 108-199, the Consolidated Appropriations Act, 2004, Congress
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                                        provided $50 million to HHS to enhance vaccine production capacity.3 Funding was used
                                        in part to award a $10 million contract to a domestic manufacturer of injectable flu
                                        vaccine to assure a year-round supply of eggs for vaccine production.4

                                             FY2005 -- Regular Appropriations. In February 2004, the Administration
                                        requested $100 million in FY2005 appropriations, again for HHS to expand vaccine
                                        production capacity.5 In October 2004, while Congress was considering FY2005
                                        appropriations, there was a production failure at a plant supplying half of the nation's
                                        supply of injectable seasonal flu vaccine. This resulted in a nationwide shortage, and
                                        focused attention on the frailty of the vaccine production system. At the same time, H5N1
                                        avian flu was spreading through Asia. In December 2004, Congress passed P.L. 108-447,
                                        the Consolidated Appropriations Act, 2005, providing HHS with the requested $100
                                        million to bolster flu vaccine production capacity, including the purchase of flu vaccine.6

                                             FY2005 -- Supplemental Appropriations. In May 2005, Congress passed P.L.
                                        109-13, the Emergency Supplemental Appropriations Act for Defense, the Global War
                                        on Terror, and Tsunami Relief, 2005, providing $25 million to USAID for programs to
                                        control the global spread of avian flu, and stipulating that $15 million of it be transferred
                                        to the Centers for Disease Control and Prevention (CDC). The law also provided $58
                                        million to CDC to purchase flu countermeasures (vaccines and antiviral drugs) for the

                                        2
                                            HHS, Budget in Brief, FY2004, February 2003, pp. 94 and 96, at [http://www.hhs.gov/budget/].
                                        3
                                            P.L. 108-199, 118 Stat. 251. This amount was subject to a 0.59% rescission.
                                        4
                                          HHS: "Secretary Thompson Announces Contract to Secure Future Egg Supply for Flu
                                        Vaccines," press release, November 9, 2004; and "Pandemic Influenza Funding Activities," at
                                        [http://www.hhs.gov/aspr/barda/procurement/panflu.html].
                                        5
                                            HHS, Budget in Brief, FY2005, February 2004, p. 102.
                                        6
                                          P.L. 108-447, 118 Stat. 3138. The act also provided $300,000 above the budget request to the
                                        Food and Drug Administration (FDA), for flu vaccine activities. These amounts were subject
                                        to a 0.8% rescission.
                                                                                       CRS-3

                                        Strategic National Stockpile, and $10 million to HHS for sewer improvements to support
                                        an expansion of the nation's only domestic production facility for injectable flu vaccine.7

                                             FY2006 -- Regular Appropriations. In February 2005, the Administration
                                        requested $120 million for HHS for pandemic preparedness for FY2006, including
                                        ongoing work to expand vaccine production capacity.8 In July 2005, the Administration
                                        sought an additional $150 million to purchase and stockpile flu antiviral drugs and
                                        prototype H5N1 vaccines.9 In December 2005, Congress provided funding for pandemic
                                        flu in FY2006 emergency supplemental appropriations (discussed below), using this
                                        vehicle, rather than regular appropriations, to provide the bulk of pandemic funding for
                                        FY2006. Also in December 2005, Congress passed regular FY2006 appropriations for
                                        HHS in P.L. 109-149, the Departments of Labor, Health and Human Services, and
                                        Education, and Related Agencies Appropriations Act, 2006, providing $63.6 million to
                                        HHS for general public health preparedness activities, including efforts to bolster
                                        domestic flu vaccine production capacity and to stockpile vaccine.10

                                              FY2006 -- Supplemental Appropriations. As Congress weighed regular
                                        appropriations for FY2006, H5N1 avian flu spread to Europe, and Hurricane Katrina
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                                        raised concerns about the nation's general level of disaster readiness. In November 2005,
                                        the Administration requested $7.1 billion in emergency supplemental funds for avian and
                                        pandemic flu preparedness.11 This included $6.7 billion for HHS in amounts to be
                                        obligated over three years -- $3.2 billion for FY2006, $2.3 billion for FY2007, and $1.2
                                        billion for FY2008 -- and the remainder for FY2006 activities in several other
                                        departments and agencies. (See Table 2.) The bulk of the amount requested for HHS
                                        was to support the expansion of domestic vaccine manufacturing capacity.12

                                              First Supplemental. In December 2005, Congress provided $3.8 billion in
                                        emergency supplemental appropriations, including $3.3 billion for HHS,13 in Division B,
                                        Title II of P.L. 109-148, the Department of Defense, Emergency Supplemental
                                        Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza
                                        Act, 2006. The distribution of these funds to various federal departments and agencies
                                        is presented in Table 2. Most of the difference between the $7.1 billion request and the


                                        7
                                            H.Rept. 109-72, p. 144, and pp. 149-150.
                                        8
                                            HHS, Budget in Brief, FY2006, February 2005, text, p. 112, and table, p. 113.
                                        9
                                          White House Office of Management and Budget (OMB), Estimate No. 9, July 15, 2005, at
                                        [http://www.whitehouse.gov/omb/budget/amendments/amendment_7_15_05.pdf].
                                        10
                                          P.L. 109-149, 119 Stat. 2857-2858. Pursuant to Section 3801 of P.L. 109-148, this amount was
                                        subject to a 1% rescission.
                                        1 1
                                               OMB,      Estimate       No.     15,    November          1,   2005,                at
                                        [http://www.whitehouse.gov/omb/budget/amendments/supplemental_11_01_05.pdf].
                                        12
                                          Testimony of Michael O. Leavitt, Secretary of Health and Human Services, hearing on
                                        Pandemic Influenza before the House Committee on Appropriations, Subcommittee on Labor,
                                        Health and Human Services, and Education, November 2, 2005, 109th Cong., 1st Sess.
                                        13
                                          See P.L. 109-148, 119 Stat. 2783 for amounts to FDA, which is funded through Agriculture,
                                        Rural Development, Food and Drug Administration, and Related Agencies Appropriations, and
                                        119 Stat. 2786-2787 for the remaining HHS activities.
                                                                                       CRS-4

                                        $3.8 billion appropriation resulted because Congress did not fund the "out years" of the
                                        Administration's HHS request, i.e., the amounts for FY2007 and FY2008. In report
                                        language (H.Rept. 109-359), conferees directed the Secretary of HHS to report to the
                                        appropriations committees on a semi-annual basis regarding the use of the $3.3 billion
                                        provided. HHS has submitted a report to congressional appropriators, and has published
                                        updates on these activities.14

                                             Second Supplemental. In February 2006, in its FY2007 budget request, HHS
                                        repeated its November 2005 request for $2.3 billion in FY2007 emergency supplemental
                                        funds for pandemic flu, but sought the funds prior to the regular FY2007 appropriations
                                        cycle. (HHS called the $2.3 billion amount an "allowance."15) In June 2006, Congress
                                        provided $2.3 billion in supplemental funds to HHS in Title IV of P.L. 109-234, the
                                        Emergency Supplemental Appropriations Act for Defense, the Global War on Terror, and
                                        Hurricane Recovery, 2006.16 Congress authorized the Secretary of HHS to use most of
                                        the funds to further federal domestic preparedness activities, the vaccine initiative
                                        (including the construction or renovation of privately owned buildings), and stockpiling
                                        of antiviral drugs and medical supplies. Congress directed that $30 million be transferred
                                        to USAID for global disease control activities. No other departments or agencies received
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                                        funds specifically for avian or pandemic flu in the act. (See Table 2.)

                                             FY2007 -- Regular Appropriations. In February 2006, in addition to
                                        supplemental funds noted above, the Administration requested $352 million for HHS
                                        pandemic flu activities in regular FY2007 appropriations.17 Coincident with passage of
                                        the second FY2006 supplemental, the House and Senate Committees on Appropriations
                                        each recommended $78.9 million for the PHSSEF. The Senate committee recommended
                                        an additional $92 million for domestic and global pandemic flu activities at CDC.18
                                        Similarly, the House passed Agriculture appropriations for FY2007, including $28.1
                                        million for pandemic flu activities at the Food and Drug Administration (FDA), and the
                                        Senate committee reported Agriculture appropriations, including a $50.5 million increase
                                        for FDA pandemic flu activities, to make the FY2007 recommended total in excess of $60
                                        million.19

                                              The amounts recommended above were not subsequently enacted. In February 2007,
                                        Congress passed FY2007 appropriations for HHS in H.J.Res. 20, the Revised Continuing
                                        Appropriations Resolution, 2007 (P.L. 110-5). The law was not accompanied by a
                                        conference report. Except for amounts specified -- including an amount for pandemic
                                        flu -- the law provided that departments be funded through FY2007 at the FY2006 level,


                                        14
                                          HHS: Report to Congress, "Pandemic Influenza Preparedness Spending, Conference Report
                                        109-359," June 15, 2006; and Pandemic Planning Updates I-IV, at [http://www.pandemicflu.gov/
                                        plan/tab1.html].
                                        15
                                             HHS, Budget in Brief, FY2007, February 2006, pp. 99-101.
                                        16
                                             P.L. 109-234, 120 Stat. 479-480.
                                        17
                                             HHS, Budget in Brief, FY2007, February 2006, pp. 99-101.
                                        18
                                             H.Rept. 109-515, June 20, 2006, p. 169; S.Rept. 109-287, July 20, 2006, pp. 7, 90, 96, and 221.
                                        19
                                          H.Rept. 109-463, May 12, 2006, p. 115; S.Rept. 109-266, June 22, 2006, p. 144. Amounts
                                        reported include some carryover of the $20 million provided in P.L. 109-148.
                                                                                    CRS-5

                                        with certain rescissions and salary adjustments. P.L. 110-5 explicitly provided $100
                                        million to the PHSSEF, to be transferred to CDC, for preparedness and response to
                                        pandemic flu and other emerging infectious diseases. It also rescinded $29.7 million from
                                        CDC regular appropriations for FY2006, intended for the purchase of annual bulk
                                        monovalent influenza vaccine (to bolster supplies of seasonal flu vaccine). It did not
                                        mention any additional HHS amounts for flu preparedness. Though it is possible that the
                                        Department funded additional pandemic flu activities with a portion of its overall
                                        appropriation for FY2007, specific amounts, if any, have not been published.

                                             FY2007 -- Supplemental Appropriations. Two FY2007 supplemental
                                        appropriations bills (H.R. 1591 and P.L. 110-28) would have provided an appropriation
                                        to HHS for pandemic flu, but in neither case was the provision enacted. The conference
                                        report for H.R. 1591, the U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and
                                        Iraq Accountability Appropriations Act, 2007, which would have provided $625 million
                                        for pandemic flu to the PHSSEF, was vetoed by President Bush on May 1, 2007. H.R.
                                        2206, a bill with the same name that passed in the House, would also have provided $625
                                        million to the PHSSEF, but the provision was removed before the bill's enactment as P.L.
                                        110-28. The law as enacted provided funds to USAID and the Department of the Interior
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                                        for avian flu control. The Administration had opposed, among other things, the inclusion
                                        of funding for "avian flu preparedness" as emergency spending in H.R. 2206, saying that
                                        it was adequately addressed in the FY2008 budget request.20

                                             FY2008. As discussed earlier, the Administration requested, in November 2005,
                                        $7.1 billion in supplemental funds for pandemic preparedness, of which $1.16 billion was
                                        to be available to HHS in FY2008. The supplemental amount requested for FY2008 has
                                        not been appropriated. In its budget proposal for FY2008, the Administration requested
                                        $1.19 billion in regular appropriations for pandemic flu, including $870 million for the
                                        PHSSEF to be available until expended, and $322 million for ongoing agency activities,
                                        principally at CDC, FDA and the National Institutes of Health (NIH).21

                                             On November 13, 2007, President Bush vetoed H.R. 3043, the Departments of
                                        Labor, Health and Human Services, and Education, and Related Agencies Appropriations
                                        Act, 2008. The House failed to override the veto on November 15, 2007. The conference
                                        report would have provided $764 million to the PHSSEF for pandemic flu activities, of
                                        which $686 million was to be used for the development and purchase of vaccine, antiviral
                                        drugs, and other supplies. The conference report also included, for CDC, $37 million for
                                        immunization activities related to both seasonal and pandemic flu, and $69 million for
                                        global pandemic flu preparedness activities.22 Agriculture appropriations for FY2008,
                                        which may include pandemic preparedness funding for FDA, are also pending at this time.


                                        20
                                          OMB, Statement of Administration Policy, H.R. 2206, the U.S. Troop Readiness, Veterans'
                                        Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007, May 10, 2007, at
                                        [http://www.whitehouse.gov/omb/legislative/sap/110-1/hr2206sap-h.pdf]. It is not clear in this
                                        statement whether the reference to "avian flu preparedness" was intended to include the amounts
                                        intended for pandemic preparedness efforts at HHS, which were removed from the enacted law.
                                        Seasonal, avian and pandemic flu are distinct threats, and are defined on the federal flu
                                        preparedness website at [http://www.pandemicflu.gov/].
                                        21
                                             HHS, Budget in Brief, FY2008, February 2007, pp. 102-104.
                                        22
                                             H.Rept. 110-424, November 5, 2007, pp. 125, 134, and 164-165.
                                                                                         CRS-6

                                                 Table 1. HHS Appropriations Targeted for Pandemic Flu
                                                                                  (dollars in millions)

                                                                                                                                            FY2008
                                          Funding mechanism                      FY2004        FY2005        FY2006        FY2007
                                                                                                                                            request
                                          Regular appropriations                     $50a          $99b          $63d           $100f       $1,192g
                                          Supplemental appropriations                   0           83c        5,620e              0              0
                                                                                                                                       f
                                          TOTAL                                       $50         $182        $5,683            $100         $1,192

                                        a. Reflects a 0.59% rescission.
                                        b. Reflects a 0.8% rescission.
                                        c. Includes $15 million transferred to CDC from USAID.
                                        d. Amount is not restricted to avian and pandemic flu activities, and reflects a 1.0% rescission.
                                        e. Includes $30 million to be transferred to USAID.
                                        f. Additional amounts may have been allocated from the total HHS appropriation.
                                        g. Of this amount, $870 million is requested to be available until expended.


                                                        Table 2. FY2006 Supplemental Appropriations
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                                                                  for Avian and Pandemic Flu
                                                                                  (dollars in millions)

                                                                                      Supplemental
                                         Department or Agency                                               P.L. 109-148           P.L. 109-234
                                                                                        requesta
                                         Agriculture                                             $91.4                  $91.4                     0
                                         Defense                                                 130.0                  130.0                     0
                                         HHS
                                            (Request for FY2006)                              3,200.0b             3,320.0b                2,300.0c
                                            (Request for FY2007)                               2,300.0                    0                       0
                                            (Request for FY2008)                               1,160.0                    0                       0
                                            Total for three years                             6,660.0b             3,320.0b                2,300.0c
                                         Homeland Security                                        47.3                 47.3                       0
                                         Interior                                                 11.6                 11.6                       0
                                         State                                                    38.5                 31.0                       0
                                         Veterans Affairs                                         27.0                 27.0                       0
                                         USAID                                                   131.5                131.5                       0
                                         TOTAL                                                $7,137.3             $3,789.8                $2,300.0

                                        a. White House Office of Management and Budget, Estimate No. 15, Nov. 1, 2005, at [http://www.
                                               whitehouse.gov/omb/budget/amendments/supplemental_11_01_05.pdf].
                                        b. Includes $20 million for FDA, provided in Agriculture appropriations.
                                        c. Includes $30 million to be transferred to USAID.