For other versions of this document, see http://wikileaks.org/wiki/CRS-RL32549 ------------------------------------------------------------------------------ Order Code RL32549 CRS Report for Congress Received through the CRS Web Project BioShield: Legislative History and Side-by-Side Comparison of H.R. 2122, S. 15, and S. 1504 August 27, 2004 Frank Gottron Analyst in Science and Technology Policy Resources, Science, and Industry Division Eric Fischer Senior Specialist in Science and Technology Policy Resources, Science, and Industry Division Congressional Research Service ~ The Library of Congress Project BioShield: Legislative History and Side-by-Side Comparison of H.R. 2122, S. 15, and S. 1504 Summary Few effective countermeasures currently exist to deal with chemical, biological, radiological, and nuclear terror agents. In early 2003, the Bush administration proposed Project BioShield to stimulate the development of such countermeasures and to procure them for the Strategic National Stockpile (SNS). Congress considered three bills that incorporated much of the administration's proposal: S. 15 (Gregg), H.R. 2122 (Tauzin), and S. 1504 (Gregg). H.R. 2122 passed the House on July 16, 2003. S. 15 passed the Senate on May 25, 2004 in an amended form similar to H.R. 2122. This version of S. 15 passed the House on July 14, 2004. President Bush signed S. 15 into law as the Project BioShield Act of 2004 (P.L. 108-276) on July 21, 2004. Although many of the details of Project BioShield changed during Congressional consideration, all the proposals shared similar key provisions. Each bill would have provided expedited hiring, procurement, and grant awarding procedures for bioterrorism-related products and services. Each bill would have provided a market guarantee for countermeasure producers by allowing the Secretary of Health and Human Services (HHS) to contract to procure countermeasures still in development. Thus, several years before a company plans to be able to deliver a countermeasure, the company would have been assured that if they successfully develop the countermeasure the government is obligated to purchase a set amount of it at a set price. Each bill would have authorized the HHS Secretary to allow the emergency use of countermeasures that lack Food and Drug Administration approval. Congress changed many important aspects of the Administration's proposal. The most important change related to the funding mechanism. The Administration requested a permanent, indefinite appropriation, to be spent at the President's discretion, for the purchase of countermeasures. The enacted version of Project BioShield authorizes the appropriation of $5.593 billion for FY2004-FY2013. The Department of Homeland Security (DHS) Appropriations Act (P.L. 108-90) appropriated this amount. The Project BioShield Act of 2004 (P.L. 108-276) also: transfers the SNS from DHS to HHS, permits procurement of countermeasures with commercial markets, permits countermeasure procurement contracts to be written up to eight years before countermeasures are expected to be deliverable, and authorizes appropriations to allow DHS to improve its ability to perform threat analysis. A provision that would have allowed HHS to develop countermeasures directly was excluded from the enacted version Project BioShield. This report will not be updated. For more analysis and the current status of Project BioShield, see CRS Report RS21507, Project BioShield, by Frank Gottron. Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Legislative History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Senate Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 House Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Presidential Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Related Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Comparison of the Bills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Similarities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 List of Tables Table 1. Short Title . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Table 2. New Health and Human Services Secretary Authorities for Countermeasure Research and Development . . . . . . . . . . . . . . . . . . . . . . . . 7 Table 3. Biomedical Countermeasures Procurement . . . . . . . . . . . . . . . . . . . . . 25 Table 4. Authorization for Medical Products for Use in Emergencies . . . . . . . . 57 Table 5. Required Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 Table 6. Outreach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Table 7. Export Control Recommendation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Table 8. Interagency Coordination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Table 9. Smallpox- Related Amendments to the Homeland Security Act and Public Health Services Act . . . . . . . . . . . . . . 108 Table 10. Additional HHS Secretary Authorities During National Emergencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 Table 11. Special Funding Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Project BioShield: Legislative History and Side-by-Side Comparison of H.R. 2122, S. 15, and S. 1504 Introduction Several high profile incidents since 2001 have highlighted the nation's vulnerability to bioterrorism. Most prominent of these were the anthrax mailings of 2001. These caused five deaths, required thousands to take prophylactic antibiotics, and cost millions of dollars to clean up. If there had not been an effective antibiotic treatment for this strain of anthrax, the death toll would have been even higher. Other prominent incidents include the discovery of the toxin ricin in Senator Frist's office in the Dirksen Senate Office Building office in February 2004 and in a postal facility in Greenville, South Carolina, in October 2003. The Secret Service also intercepted a letter containing ricin addressed to the White House in October 2003. Ricin, a deadly toxin, lacks any Food and Drug Administration (FDA) approved treatments or prophylaxis.1 Many of the other biological threats deemed most dangerous by the Centers for Disease Control and Prevention (CDC) also lack effective FDA-approved treatments and prophylactics. For example, botulinum toxin, plague, tularemia, and many viral hemorrhagic fevers (VHFs) lack licensed vaccines, while smallpox and VHFs lack any specific treatment.2 Additionally, many of the vaccines and treatments that currently exist are suboptimal for responding to bioterrorism. For example, the Department of Health and Human Services (HHS) has called for better vaccines for anthrax and smallpox and better treatments for anthrax, plague, and botulism.3 1 For more information on ricin, see CRS Report RS21383, Ricin: Technical Background and Potential Role in Terrorism, by Dana A. Shea and Frank Gottron. 2 For more information on potential chemical and biological terrorism agents and the availability of countermeasures, see CRS Report RL32391, Small-scale Terrorist Attacks Using Chemical and Biological Agents: An Assessment Framework and Preliminary Comparisons, by Dana A. Shea and Frank Gottron. 3 National Institute of Allergy and Infectious Disease, NIAID Biodefense Research Agenda for CDC Category A Agents, Department of Health and Human Services, Washington, DC, February, 2002. CRS-2 Several factors likely contribute to this paucity of bioterrorism countermeasures, including a lack of a financial incentives to develop countermeasures,4 the perception of a relatively high threat of litigation stemming from adverse reactions to the countermeasures,5 and the lack of success of a Department of Defense effort to develop such countermeasures.6 In addition, because these diseases are rare, many companies apparently have balked at spending millions of dollars developing a product with such a small potential market.7 To encourage the development of new biomedical countermeasures, President Bush proposed Project BioShield in his 2003 State of the Union address. The 108th Congress considered three bills that incorporated the administration's proposal: S. 15 (Gregg), H.R. 2122 (Tauzin), and S. 1504 (Gregg). Most of the attention garnered by Project BioShield has focused on countermeasures against bioterrorism. However, Project BioShield also applies to countermeasures against chemical, radiological, and nuclear attacks. This report provides a brief legislative history and a side-by-side comparison of the three bills, including versions of S. 15 as initially reported and as enacted. Such a comparison may be useful both with respect to congressional oversight of Project BioShield activities and with respect to future legislative initiatives relating to countermeasure procurement. Legislative History Senate Action. Senator Gregg introduced S. 15 on March 11, 2003. The Senate Committee on Health, Education, Labor, and Pensions (HELP) reported S. 15 on March 25, 2003, with an amendment in the nature of a substitute and without a written report. In the comparison tables below, this version is referred to as "S. 15 as Reported by Committee." Senator Gregg introduced S. 1504 on July 30, 2003. It shared many of the provisions found in H.R. 2122, which the House had passed on June 16, 2003. S. 1504 was placed directly on the Senate Legislative Calendar. In the comparison tables below, this version is listed as "S. 1504 as Introduced." 4 Alan Pemberton, Pharmaceutical Research and Manufacturers of America, Testimony before the U.S. House of Representatives Select Committee on Homeland Security, May 15, 2003. 5 Dr. Kim Bush, President Vaccines Division, Baxter Healthcare Corp, Testimony before the U.S. Senate Committee on Health, Education, Labor, and Pensions, Health Subcommittee, January 30, 2003. 6 Institute of Medicine and National Research Council, Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents, National Academy Press, Washington DC, 2004. 7 See CRS Report RL30913, Pharmaceutical Research and Development: A Description and Analysis of the Process by Richard Rowberg. CRS-3 On May 19, 2004 the Senate passed S. 15 with an amendment in the nature of a substitute (99-0). The amended and passed version of S. 15 had relatively minor differences from H.R. 2122 (see below). This version of S. 15 was passed by the House and became the Project BioShield Act of 2004 (P.L. 108-276). In the comparison tables below, this version is referred to as "S. 15 as Enacted." House Action. Representative Tauzin introduced H.R. 2122 on May 15, 2003. It was referred to the Committee on Energy and Commerce, Committee on Government Reform, Committee on Armed Services, and the Select Committee on Homeland Security. The Committee on the Judiciary chose not to seek a serial referral.8 Committee Hearings. The House Committee on Energy and Commerce Subcommittee on Health held a joint hearing with the House Select Committee on Homeland Security Subcommittee on Emergency Preparedness and Response entitled "Furthering Public Health Security: Project BioShield" on March 27, 2003. The House Committee on Government Reform held a hearing to consider the "Project Bioshield Act" on April 4, 2003. The House Select Committee on Homeland Security held a hearing on "BioShield: Countering the Bioterrorist Threat" on May 15, 2003. The House Select Committee on Homeland Security Subcommittee on Emergency Preparedness and Response and the Subcommittee on Intelligence and Counterterrorism held a joint hearing on "Does the Homeland Security Act of 2002 Give the Department the Tools It Needs To Determine Which Bio-Warfare Threats Are Most Serious?" on June 5, 2003. On June 6, 2003 the House Select Committee on Homeland Security held a hearing on "Bioshield: Lessons from Current Efforts To Develop Bio-Warfare Countermeasures." Committee Reports and Amendments. The House Committee on Energy and Commerce reported H.R .2122 (H.Rept. 108-147, Part 1) on June 10, 2003. The House Committee on Armed Services discharged H.R. 2122 on June 11, 2003. The House Committee on Government Reform reported H.R. 2122 with amendments on June 12, 2003 (see H.Rept. 108-147, Part 2). The House Select Committee on Homeland Security reported H.R. 2122 with amendments on July 8, 2003 (see H.Rept. 108-147, Part 3). The version reported by the House Select Committee on Homeland Security is the version that passed the House. In the comparison charts below, this is the version referred to as "H.R. 2122 as Passed by the House." Floor Action. The House of Representatives passed H.R. 2122 on July 16, 2003 (421-2). The House passed S. 15 on July 14, 2004 (414-2). Presidential Action. S. 15 was signed into law by President Bush on July 21, 2004 (P.L. 108-276). 8 U.S. Congress, Project BioShield Act of 2003: H.Rept. 108-147 Part I, 108th Congress, first session, pp. 20-21. CRS-4 Related Legislation. The Department of Homeland Security Appropriations Act, 2004 (P.L. 108-90, enacted October 1, 2003) appropriated $5.593 billion for FY2004-FY2013 to procure medical countermeasures against biological terror attacks. Of this amount, up to $890 million may be obligated in FY2004 and no more than $3.418 billion may be obligated through FY2008. The enactment of this law effectively resolved the funding differences that had been pending between S. 15 and H.R. 2122 at that time. S. 15 as reported by the Senate HELP Committee called for a permanent indefinite spending appropriation, while H.R. 2122 authorized a specific appropriation amount. P.L. 108-90 contained funding levels identical to those authorized in H.R. 2122. Although P.L. 108-90 specified that those funds were only for medical countermeasures against biological terror attacks, the Project BioShield Act of 2004 (P.L. 108-276) changed this to allow countermeasures against chemical, biological, radiological, and nuclear terrorism. The National Defense Authorization Act for Fiscal Year 2004 (P.L. 108-136, enacted November 24, 2003) contained some Department of Defense-related language similar to that found in S. 15 as reported by the Senate HELP Committee and H.R. 2122. It gave the Secretary of Defense some authorities similar to those given to the Secretary of Health and Human Services by the Project BioShield Act of 2004. These new authorities relate to the hiring of biomedical countermeasure consultants, the procurement of biomedical countermeasures, and the emergency use of unapproved countermeasures for the military. The Defense Secretary's authorities relate to Department of Defense programs and military personnel, whereas the HHS Secretary's authorities relate to HHS programs and to civilian populations. The Consolidated Appropriations Act, 2004 (P.L. 108-199, enacted January 23, 2004), reduced the funds available for obligation in FY2004 from $890 million to $885 million. Comparison of the Bills All of the Project BioShield-related legislative proposals shared the same goal of increasing the development and purchase of biomedical countermeasures for the SNS. Each also largely reflected the Administration's proposals on a broad scale. However, Congress, through its deliberative process, changed many of the details in each bill. Similarities. These bills shared many provisions. Each would have provided expedited hiring, procurement, and grant awarding procedures for bioterrorism- related products and services. These provisions were designed to make it easier for HHS to quickly commit substantial funds to biomedical countermeasure projects. Each bill would have provided a market guarantee for countermeasure producers by allowing the HHS Secretary to contract to procure countermeasures still in development. Thus, several years before a company plans to be able to deliver a countermeasure, the company would be assured that if they successfully develop the countermeasure the government is obligated to purchase a set amount of it at a set price. Under each bill, the manufacturing company can only receive payment upon countermeasure delivery, with some minor exceptions. Each bill would have authorized the HHS Secretary to allow the emergency use of countermeasures that lack FDA approval. CRS-5 Differences. Funding. The largest difference among the bills was the difference in funding mechanism. S. 15 as reported by the Senate HELP Committee would have granted a permanent, indefinite appropriation for purchasing countermeasures to be spent at the President's discretion. This mandatory funding, which was also part of the original Administration proposal, would not be subject to the annual appropriations process. The Administration predicted that it would spend approximately $5.6 billion for FY2004-FY2013 for BioShield-related countermeasure procurement. The Congressional Budget Office estimated that approximately $8.1 billion would be spent over that time period.9 H.R. 2122, S. 1504, and S. 15 as amended and enacted authorize specific funding for the program but do not appropriate funds. All three of these authorize the exact appropriation amounts found in the Department of Homeland Security Appropriation Act, 2004 (P.L. 108-90) that was passed while the Project BioShield legislation was under consideration. There were minor differences in the mechanisms of funding between H.R. 2122 and S. 1504. S. 15 as enacted adopted the H.R. 2122 mechanism. SNS Transfer. Congress created the National Pharmaceutical Stockpile (NPS), the forerunner to the SNS, in the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999 (P.L. 105-277). The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188) essentially redesignated the NPS as the SNS and listed specific requirements regarding SNS management and maintenance. The Homeland Security Act of 2002 (P.L. 107-296) transferred the SNS program to the Department of Homeland Security. S. 15 as enacted transferred the SNS back to HHS. This provision was not in any of the other bills. Countermeasure Qualifications. The bills differed in which countermeasures qualify for procurement under Project BioShield. S. 15 as reported by the Senate HELP Committee and S. 1504 would have excluded any countermeasure that has a significant market other than as a countermeasure. H.R. 2122 and S. 15 as enacted allow the purchase of countermeasures even if they have other significant markets. This change may encourage the development of countermeasures that can protect against more than one agent, such as new wide- spectrum antibiotics. Such products are more likely to have other commercial applications and markets. Thus, while very desirable for the SNS, they would have been excluded from Project BioShield funding under S. 15 as reported and S. 1504. S. 15 as reported by the Senate HELP Committee and S. 1504 required that products be likely to have FDA approval within five years. H.R. 2122 required that countermeasures be likely to be approved sometime in the future. S. 15 as enacted requires that countermeasures be likely to be approved within eight years. The enacted language will allow the HHS Secretary to contract to purchase 9 U.S. Congress. Cost Estimate: S. 15 Project BioShield Act of 2003. Congressional Budget Office. May 7, 2003. CRS-6 countermeasures that are earlier in the development process than would the other Senate versions, but not as early as H.R. 2122 would have allowed. H.R. 2122, S. 1504, and S. 15 as reported by the Senate HELP Committee specify that countermeasures should be deliverable within five years. S. 15 as enacted specifies that countermeasures should be deliverable within eight years. HHS Countermeasure Development Program. H.R. 2122 would have authorized the HHS Secretary to "initiate and sustain a program that results in the delivery of priority countermeasures for placement in the stockpile." This provision would have allowed the government to directly develop countermeasures. This could be done through several mechanisms including government owned-government operated (GO-GO) facilities or government owned-contractor operated (GO-CO) facilities. This provision was not included in S. 15 as enacted. Patient Protection during Emergencies. S. 1504 and S. 15 as enacted grant the HHS Secretary authority, during a national emergency, to temporarily waive or modify some patient protection provisions of the Social Security Act and the Public Health Security and Bioterrorism Preparedness Act of 2002. These provisions concern patient privacy and which hospitals patients can be directed to or away from pursuant to a state emergency plan. H.R. 2122 and S. 15 as reported by the Senate HELP Committee lacked this provision. DHS Terrorism Analyst Hiring. H.R. 2122 and S. 15 as enacted authorize appropriations to hire more biological and chemical terrorism analysts in the Department of Homeland Security's Directorate for Information Analysis and Infrastructure Protection (IAIP). They also authorize appropriations to acquire and deploy facilities that permit the Undersecretary of IAIP to access all classified information to which he is entitled. S. 15 as reported by the Senate HELP Committee and S. 1504 lacked similar provisions. Other Differences. Several other notable differences, including reporting and recordkeeping requirements, are detailed the tables below. The italics in the tables highlight language differences between the bills. CRS-7 Table 1. Short Title Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Short Title Sec. 1 Sec. 1 Sec. 1 Sec. 1 "Project BioShield Act of Same as S. 15 as Reported by Same as S. 15 as Reported by "Project BioShield Act of 2003." Committee. Committee 2004." Note: Italics highlight language differences between the bills. Table 2. New Health and Human Services Secretary Authorities for Countermeasure Research and Development Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Amendment Sec. 2 Sec. 2 Sec. 2 Sec. 2 to the Public Amends Part B of title IV of Amends Part B of title III of Same as S. 15 as Reported by Same as H.R. 2122. Health the Public Health Service Act the PHSA, (42 U.S.C. 243 et Committee. Services Act (PHSA, 42 U.S.C. 284 et seq.) by inserting "Sec. seq.) by adding "Sec. 409J 319F-1 Authority for Use of Biomedical Countermeasure Certain Procedures Research and Development." Regarding Biomedical Countermeasure Research and Development Activities." CRS-8 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Defining Sec. 2 (a) "Sec. 409J (g)" Sec. 2 (a) "Sec. 319F-1 Sec. 2 (a) "Sec. 409J (g)" Sec. 2 (a) "Sec. 319F-1 Counter- Defines a qualified (a)(2)" and Sec. 2 (e) Same as S. 15 as Reported by (a)(2)" and Sec. 2 (d) measures countermeasure as a drug (as Defines qualified Committee. Same as S. 15 as Reported by that term is defined by countermeasure as a priority Committee. section 201(g)(1) of the countermeasure (as defined Federal Food, Drug, and in section 319F(h) and as Cosmetic Act (21 U.S.C. determined by the Secretary 321(g)(1))), biological in accordance with such product (as that term is section and consistent with defined by section 351(i) of sections 302(2) and 304(a) of this Act (42 U.S.C. 262(i))), the Homeland Security Act or device (as that term is of 2002) defined by section 201(h) of against a chemical, the Federal Food, Drug, and biological, radiological, or Cosmetic Act (21 U.S.C. nuclear agent that may cause 321(h))) that the Secretary a public health emergency determines to be a priority affecting national security. (consistent with sections 302(2) and 304(a) of the Homeland Security Act of 2002) to -- CRS-9 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Defining Sec. 2 (e) Sec. 2 (a) "Sec. 409J (g)" Sec. 2 (d) Counter- Defines a countermeasure as Same as S. 15 as Reported by Same as H.R. 2122. measures a drug, biological product, Committee. (continued) device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that can be used to -- (A) treat, identify, or prevent (1) to treat, identify, or Same as S. 15 as Reported by Same as H.R. 2122. harm from any biological, prevent infection by a Committee. chemical, radiological, or biological agent or toxin or nuclear agent that may cause harm from any other agent a public health emergency that may cause a public affecting national security; or health emergency; or (B) treat, identify, or prevent (2) to treat, identify, or Same as H.R. 2122. Same as H.R. 2122. harm from a condition that prevent harm from a may result in adverse health condition that may result in consequences or death and adverse health consequences may be caused by or death and may be caused administering a drug, by the administering of a biological product, or device countermeasure described in that is used as described in (1). subparagraph (A). CRS-10 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Lead Sec. 2 (a) "Sec. 409J (a)(2)" No similar provision. Sec. 2 (a) "Sec. 409J (a)(2)" No similar provision. Institute The Director of the National Same as S. 15 as Reported by Institutes of Health (NIH) Committee. shall carry out these authorities. The National Institute of Allergy and Infectious Diseases (NIAID) shall be the lead institute within NIH for performing, administering, or supporting biomedical countermeasure research and development. The NIH Director may delegate to the NIAID Director authorities as are necessary to carry out this function. The HHS Secretary may authorize the NIH Director to work through any national research institute. Interagency Sec. 2 (a) "Sec. 409J (a)(3)" Sec. 2 (a) "Sec. 319F-1 Sec. 2 (a) "Sec. 409J (a)(3)" Sec. 2 (a) "Sec. 319F-1 Cooperation Authorizes the HHS (a)(3)" Same as S. 15 as Reported by (a)(3)" Secretary to enter into Authorizes the HHS Committee. Same as H.R. 2122. interagency agreements for Secretary to enter into countermeasure research and interagency agreements for development and to use other countermeasure research and HHS agencies. development. CRS-11 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Facility Sec. 2 (a) "Sec. 409J Sec. 2 (a) "Sec. 319F-1 Sec. 2 (a) "Sec. 409J Sec. 2 (a) "Sec. 319F-1 Availability (a)(2)(D)" (a)(4)" (a)(2)(D)" (a)(4)" to the HHS Secretary can make Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by Secretary funding for countermeasure Committee. Committee. Committee. research and development facilities dependent on allowing future emergency use of facilities by the Secretary. Export No similar provision. Sec. 2 (a) "Sec. 319F-1 No similar provision. Sec. 2 (a) "Sec. 319F-1 Controls (a)(5)" (a)(5)" Each award agreement must Same as H.R. 2122. state that any products developed with BioShield funding must comply with export-related controls. CRS-12 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Expedited Sec. 2 (a) "Sec. 409J (b)(1)" Sec. (a) "Sec. 319F-1 (b)(1)" Sec. 2 (a) "Sec. 409J (b)(1)" Sec. (a) "Sec. 319F-1 (b)(1)" Maximum Procure- (A) Procurements less than (A) Same as S. 15 as (A) Same as S. 15 as (A) Same as S. 15 as would ment $25 million for property or Reported by Committee. Reported by Committee. Reported by Committee. otherwise be Authority services related to pressing $100,000. countermeasure research and development needs can follow simplified acquisition regulations. No similar provision. (B) These purchases must (B) These purchases must (B)These purchases must comply with laws and comply with laws and comply with laws and regulations relating to regulations relating to regulations relating to contract work hours and contract work hours and contract work hours and safety standards, examination safety standards, examination safety standards, examination of contractor records, and the of contractor records, the of contractor records, the Anti-Kickback Act (21 U. S. Anti-Kickback Act, bonds of Anti-Kickback Act, bonds of C. 57(a) and (b). contractors of public contractors of public buildings, limits on buildings, middlemen fees subcontractor sales, solid waste disposal, and middlemen fees, and veterans' employment veterans' employment reporting requirements. reporting requirements. (B) Appropriate internal (C) Same as S. 15 as (C) Same as S. 15 as (C) Same as S. 15 as controls shall be developed Reported by Committee. Reported by Committee. Reported by Committee. for the use of this authority. CRS-13 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Expedited Sec. (a) "Sec. 409J (b)(2)" Sec. 2 (a) "Sec. 319F-1 Sec. (a) "Sec. 409J (b)(2)" Sec. 2 (a) "Sec. 319F-1 Procure- Authorizes the use of "other (b)(2)" Same as S. 15 as Reported by (b)(2)" ment than competitive procedures" Authorizes the use of "other Committee. Same as H.R. 2122. Authority in awarding contracts if that than competitive procedures" (continued) which is being procured is in awarding contracts if that available from a limited which is being procured is number of responsible available from a limited sources and no other type of number of responsible property or services will sources. meet the need. CRS-14 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Expedited No similar provision. Sec. 2 (a) "Sec. 319F-1 No similar provision. Sec. 2 (a) "Sec. 319F-1 Procure- (b)(2)(C)" (b)(2)(C)" ment Awards must comply with Awards must comply with Authority government-wide government-wide regulations (continued) regulations, including (including requirements that requirements that offers be offers be solicited from as solicited from as many many potential sources as is potential sources as is practicable under the practicable under the circumstances, that required circumstances, that required notices be published, and that notices be published, and that submitted offers be submitted offers be considered) as such considered. regulations apply to procurements for which an agency has authority to use procedures other than competitive procedures when the property or services needed by the agency are available from only one responsible source or only from a limited number of responsible sources and no other type of property or services will satisfy the needs of the agency. CRS-15 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Expedited Sec. 2 (a) "Sec. 409J (b)(3)" Sec. 2 (a) "Sec. 319F-1 Sec. 2 (a) "Sec. 409J (b)(3)" Sec. 2 (a) "Sec. 319F-1 Micro- Procure- Procurements less than (b)(3)" Same as S. 15 as Reported by (b)(3)" purchase ment $15,000 for property or Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by maximum Authority services related to pressing Committee. Committee. would (continued) countermeasure research and otherwise be development needs can $2,500. follow micropurchase regulations. Appropriate internal controls shall be developed for the use of this authority. Government purchase card preferences do not apply to these purchases if they are greater than $2,500. CRS-16 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Contesting No similar provision. Sec. 2 (a) "Sec. 319F-1 No similar provision. Sec. 2 (a) "Sec. 319F-1 Decisions (b)(4)" (b)(4)" Made Under Notwithstanding any other Notwithstanding 28 These provision of law, contracting U.S.C.18(f), 28 U.S.C. 1491 Authorities agency decisions relating to subsection (f), and 31 U.S.C. countermeasure research and 3556, contracting agency development procurement decisions relating to can be reviewed by filing a countermeasure research and protest with the contracting development procurement agency or the Comptroller can be reviewed by filing a General. If there is a written protest with the contracting finding that a review-related agency or the Comptroller delay would harm the United General. If there is a written States, the decision to make finding that a review-related the award or procurement is delay would harm the United committed to agency States, the decision to make discretion. the award or procurement is committed to agency discretion. CRS-17 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Expedited Sec. (a) "Sec. 409J (c)" Sec. 2 (a) "Sec. 319F-1 Sec. (a) "Sec. 409J (c)" Sec. 2 (a) "Sec. 319F-1 Peer Review Allows the HHS Secretary to (c)(1)" Same as S. 15 as Reported by (c)(1)" use an expedited award Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by process, rather than the Committee. Committee. normal peer review process, for grants, contracts, and cooperative agreements less than $1.5 million related to biomedical countermeasure R&D activity, if the Secretary deems there is a pressing need for an expedited award. No similar provision. Sec. 2 (a) "Sec. 319F-1 No similar provision. Sec. 2 (a) "Sec. 319F-1 (c)(2)" (c)(2)" Determination of whether to Same as H.R. 2122. employ expedited peer review with respect to subsequent awards shall be determined without regard to the peer review procedures used for any prior peer review of that same award. CRS-18 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Agency Sec. 2(a) "Sec. 409J (d)" No similar provision. Sec. 2(a) "Sec. 409J (d)" No similar provision. Facilities HHS Secretary may acquire, Same as S. 15 as Reported by lease, construct, improve, Committee. renovate, remodel, repair, operate, and maintain laboratories, other research facilities and equipment, and other real or personal property as the Secretary determines necessary for the purpose of performing, administering, and supporting biomedical countermeasure research and development. CRS-19 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Personal Sec. 2 (a) "Sec. 409J (e)(1)" Sec. 2 (a) "Sec. 319F-1 (d)" Sec. 2 (a) "Sec. 409J (e)(1)" Sec. 2 (a) "Sec. 319F-1 (d)" Services Authorizes the HHS Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by Contracts Secretary to enter into Committee. Committee. Committee. personal services contracts with up to 30 experts or consultants with no limit on period of service. No similar provision. Sec. 2 (a) "Sec. 319F-1 No similar provision. Sec. 2 (a) "Sec. 319F-1 (d)(1)" (d)(1)" Pay cannot exceed that of the Same as H.R. 2122. U. S. President. Sec. 2 (a) "Sec. 409J (e)(2)" Sec. 2 (a) "Sec. 319F-1 Sec. 2 (a) "Sec. 409J (e)(2)" Sec. 2 (a) "Sec. 319F-1 These contractors are treated (d)(2)" Same as S. 15 as Reported by (d)(2)" as employees of HHS for Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by Federal Tort Claims Act Committee. Committee. purposes. Sec. 2 (a) "Sec. 409J (e)(3)" Sec. 2 (a) "Sec. 319F-1 Sec. 2 (a) "Sec. 409J (e)(3)" Sec. 2 (a) "Sec. 319F-1 Internal controls for this (d)(3)" Same as S. 15 as Reported by (d)(3)" authority will be Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by implemented. Committee. Committee. CRS-20 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Personal Sec. 2 (a) "Sec. 409J No similar provision. Sec. 2 (a) "Sec. 409J Sec. 2 (a) "Sec. 319F-1 Services (e)(2)(C)" (e)(2)(C)" (d)(2)(C)" Contracts The United States has the Same as S. 15 as Reported by Same as S. 15 as Reported by (continued) right to sue these contractors Committee. Committee. to recover payments (and litigation costs) made to any claimant stemming from the job-related gross misconduct of these contractors. The venue for this action will be in the district court of the United States in which such contractor resides or has its principal place of business. Streamlined Sec. 2 (a) "Sec. 409J (f)" Sec. 2 (a) "Sec. 319F-1 (e)" Sec. 2 (a) "Sec. 409J (f)(1)" Sec. 2 (a) "Sec. 319F-1 Personnel The HHS Secretary may Same as S. 15 as Reported by Same as S. 15 as Reported by (e)(1)" Authority appoint up to 30 professional Committee. Committee. Same as S. 15 as Reported by and technical employees to Committee. help NIH respond to pressing qualified countermeasure research and development needs without regard to provisions governing appointments in the competitive service or pay rates. CRS-21 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Streamlined No similar provision. No similar provision. No similar provision. Sec. 2 (a) "Sec. 319F-1 Personnel (e)(2)" Authority (A) Recruitment and (continued) appointments must be based solely on the individual's abilities, knowledge, and skills. No similar provision. No similar provision. Sec. 2 (a) "Sec. 409J (f)(2)" (B) Same as S. 1504. These U.S.C. Provisions in U.S.C. title 5 provisions relating to merit system include principles, prohibited protections personnel practices and regarding preference eligibility apply to discrimin- these appointments. ation on the basis of political affiliation, race, color, religion, national origin, sex, marital status, age, or handicap. This section of U.S. Code prohibits appointment of relatives. CRS-22 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Streamlined Sec. 2 (a) "Sec. 409J (f)(2)" Sec. 2 (a) "Sec. 319F-1 Sec. 2 (a) "Sec. 409J (f)(3)" Sec. 2 (a) "Sec. 319F-1 Personnel Internal controls for this (e)(2)" Same as S. 15 as Reported by (e)(3) Authority authority will be Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by (continued) implemented. Committee. Committee. Actions Sec. 2 (a) "Sec. 409J (h)" Sec. 2 (a) "Sec. 319F-1 (f)" Sec. 2 (a) "Sec. 409J (h)" Sec. 2 (a) "Sec. 319F-1 (f)" Committed All actions by the HHS All actions by the HHS Same as S. 15 as Reported by Same as S. 15 as Reported by to Agency Secretary under the authority Secretary under the authority Committee. Committee. Discretion of this section are committed of this section are committed to agency discretion. to agency discretion, except those deemed reviewable under Sec. 319F-1 (b)(4). CRS-23 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Technical Sec. 2 (b). Sec. 2 (b). Sec. 2 (b). Sec. 2 (b). Amendment (1) Amends the PHSA (42 (1) Same as S. 15 as Same as S. 15 as Reported by (1) Same as S. 15 as U.S.C. 287a-2) to allow the Reported by Committee. Committee. Reported by Committee. Director of NIH to work through the Director of NIAID to fund public or nonprofit entities to expand, remodel, renovate or alter existing research facilities or construct new research facilities. Increases the federal share from 50% to 75% for NIAID funded projects and from 40% to 75% of costs associated with NIAID use for multipurpose facilities. No similar provision. (2) Authorizes such sums as No similar provision. (2) Authorizes such sums as may be necessary for FY2003 may be necessary for FY2004 and FY2004 to fund these and FY2005 to fund these improvements. improvements. CRS-24 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House HHS No similar provision. Sec. 2 (c) No similar provision. No similar provision. Program to The HHS Secretary may Develop initiate and sustain a program Counter -- that results in the delivery of measures priority countermeasures for placement in the Strategic National Stockpile (SNS). Authorizes the appropriation of such sums as may be necessary for each of the fiscal years 2004 through 2013. National No similar provision. Sec. 2 (d) No similar provision. No similar provision. Vaccine Authorizes the appropriation Program of such sums as may be necessary for each of the fiscal years 2004 through 2013 for the National Vaccine Program. Technical No similar provision. Sec. 2 (e) No similar provision. Sec. 2 (d) Amendment Amends the PHSA to add the Same as H.R. 2122. Secretary of Homeland Security to the working group on the preparedness, prevention, and response to bioterrorism and other public health emergencies. CRS-25 Table 3. Biomedical Countermeasures Procurement Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Sec. 3 Sec. 3 Sec. 3 Sec. 3 Amends PHSA by adding Amends PHSA by adding Same as S. 15 as Reported by Same as H.R. 2122. Sec. 319A-1. Sec. 319F-2. Committee. Transfer of No similar provision. Sec. 3 (a) No similar provision. Sec. 3 (a) Strategic Transfers and amends the Same as H.R. 2122. National section of the Public Health Stockpile Security and Bioterrorism Language Preparedness and Response Act of 2002 (P.L. 107-188, 42 U.S.C. 300hh-12) dealing with the Strategic National Stockpile (SNS, Sec. 121) to the Public Health Services Act as section 319F-2. CRS-26 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Stockpile No similar provision. Sec. 3 (a) "Sec. 319F-2 No similar provision. Sec. 3 (a) "Sec. 319F-2 S. 15 as Manage- (a)(1)" (a)(1)" Enacted ment DHS Secretary in HHS Secretary in transfers the coordination with HHS coordination with DHS SNS from Secretary and VA Secretary Secretary shall maintain the DHS to shall maintain the Strategic Strategic National Stockpile. HHS. National Stockpile. No similar provision. In managing the Stockpile No similar provision. Same as H.R. 2122. DHS Secretary shall: No similar provision. (A) consult with the Working No similar provision. Same as H.R. 2122. Group on Bioterrorism defined in PHSA Sec. 319F (a); No similar provision. (B) ensure adequate No similar provision. Same as H.R. 2122. procedures for inventory management and accounting, and for the physical security of the stockpile; No similar provision. (C) take into consideration No similar provision. Same as H.R. 2122. the timing and location of special events; CRS-27 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Stockpile No similar provision. (D) review and revise, the No similar provision. Same as H.R. 2122. Manage- contents of the stockpile on a ment regular basis to ensure that (continued) emerging threats, advanced technologies, and new countermeasures are adequately considered; No similar provision. (E) devise plans for the No similar provision. Same as H.R. 2122. effective and timely supply- chain management of the stockpile, in consultation with appropriate Federal, State and local agencies, and the public and private health care infrastructure; CRS-28 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Stockpile No similar provision. No similar provision. No similar provision. (F) deploy the stockpile as Manage- required by the Secretary of ment Homeland Security to (continued) respond to an actual or potential emergency; No similar provision. No similar provision. No similar provision. (G) deploy the stockpile at the discretion of the Secretary to respond to an actual or potential public health emergency or other situation in which deployment is necessary to protect the public health or safety; and No similar provision. (F) ensure adequate stockpile No similar provision. (H)Same as H.R. 2122. physical security. Procure- No similar provision. Sec. 3 (a) "Sec. 319F-2 No similar provision. Sec. 3 (a) "Sec. 319F-2 ment (c)(1)(A)" (c)(1)(A)" Authority The special reserve fund Same as H.R. 2122. defined in Sec. 319F-2 (c)(10) can be used to procure security countermeasures for the SNS. CRS-29 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Definitions Sec. 3 "Sec. 319A-1 (h)(1)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 (a) "Sec. 319A-1 Sec. 3 (a) "Sec. 319F-2 H.R. 2122's of Security Defines a qualified (c)(1)(B)" (h)(1)" (c)(1)(B)" definition of Counter -- countermeasure as a Defines a security Same as S. 15 as Reported by Defines a security a priority measures biomedical countermeasure countermeasure as a priority Committee. countermeasure as a drug, counter- and for use against a CBRN agent countermeasure against a biological product, or device measure is Qualified identified as a material threat CBRN agent identified as a countermeasure against a from Sec. Counter -- that is approved or cleared by material threat, that is CBRN agent identified as a 319F(h) of measures the Food and Drug determined to be a necessary material threat, that is the Public Administration (FDA) or a countermeasure under 391F- determined to be a necessary Health biological product licensed 2(c)(2)(B), and is approved countermeasure under 391F- Service Act. by the HHS Secretary under or cleared by the Food and 2(B)(ii), and is approved or 42 U.S.C. 262, Drug Administration (FDA) cleared by the Food and Drug or a biological product Administration (FDA) or a licensed by the HHS biological product licensed Secretary under 42 U.S.C. by the HHS Secretary under 262, 42 U.S.C. 262, or is a priority or is a priority Same as S. 15 as Reported by or is a countermeasure for countermeasure for which the countermeasure for which the Committee. which the HHS Secretary HHS Secretary determines HHS Secretary determines determines that sufficient and that sufficient and that sufficient and satisfactory clinical satisfactory clinical satisfactory clinical experience or research data experience or research data experience or research data support a reasonable support a reasonable support a reasonable conclusion that the conclusion that the conclusion that the countermeasure will qualify countermeasure will qualify countermeasure will qualify for approval or licensing for approval or licensing for approval or licensing in within eight years, within five years. the future, CRS-30 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Definitions No similar provision. or is authorized for No similar provision. Same as H.R. 2122. of Security emergency use by the HHS Counter -- Secretary. measures and Qualified Counter -- measures (continued) Determina- Sec. 3 "Sec. 319A-1 (a)(1)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (a)(1)" Sec. 3 (a) "Sec. 319F-2 tion of Requires the DHS Secretary (c)(2)(A)" Same as S. 15 as Reported by (c)(2)(A)" Material to determine, on an ongoing Requires the DHS Secretary Committee. Same as H.R. 2122. Threat basis, which CBRN agents to determine, on an ongoing pose a material risk of use basis, which CBRN agents against the U.S. population. pose a material threat. Determina- Sec. 3 "Sec. 319A-1 Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 Sec. 3 (a) "Sec. 319F-2 tion of (a)(2)(A)" (c)(2)(B)" (a)(2)(A)" (c)(2)(B)" Public Requires the HHS Secretary, Requires the HHS Secretary Same as S. 15 as Reported by Same as H.R. 2122. Health in consultation with the DHS to determine the public Committee. Impact Secretary, to determine the health consequences of use public health consequences of any of the agents of use of any of the agents identified by the DHS identified by the DHS Secretary to pose a material Secretary to pose a material threat, and to determine the threat, and to determine the agents for which priority agents for which priority countermeasures are countermeasures are necessary to protect the necessary to protect the public health from a material public health from a material threat. threat. CRS-31 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Notification No similar provision. Sec. 3 (a) "Sec. 319F-2 No similar provision. Sec. 3 (a) "Sec. 319F-2 to Congress (c)(2)(C)" (c)(2)(C)" The DHS and HHS The DHS and HHS Secretaries will notify Secretaries will notify Congress when any material Congress when any material threat, public health impact, threat, public health impact, or necessary countermeasure or necessary countermeasure determination is made. Such determination is made. notice shall be in unclassified or, if necessary classified form. Assuring No similar provision. Sec. 3 (a) "Sec. 319F-2 No similar provision. Sec. 3 (a) "Sec. 319F-2 Access to (c)(2)(D)" (c)(2)(D)" Threat All information to which the Same as H.R. 2122. Information DHS Secretary is entitled, regardless of classification level, will be used in making material threat determinations. Assessment Sec. 3 "Sec. 319A-1 (b)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (b)" Sec. 3 (a) "Sec. 319F-2 of The HHS Secretary, in (c)(3)" Same as S. 15 as Reported by (c)(3)" Availability consultation with the DHS Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by and Appro- Secretary, shall assess the Committee. Committee. priateness of availability and Counter -- appropriateness of measures countermeasures to address identified material threats. CRS-32 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Call for Sec. 3 "Sec. 319A-1 (c)(1)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (c)(1)" Sec. 3 (a) "Sec. 319F-2 Develop- If a countermeasure is found (c)(4)(A)" Same as S. 15 as Reported by (c)(4)(A)" ment of appropriate but not available, If a countermeasure is found Committee. Same as H.R. 2122. Counter -- the DHS and HHS appropriate but not available measures Secretaries may jointly or available but cleared only submit, for presidential for alternative purposes, the approval, a call for the DHS and HHS Secretaries development of such may jointly submit, for countermeasure and a presidential approval, a call commitment to recommend for the development of such the procurement of the first countermeasure and a developed appropriate commitment to recommend countermeasure. the procurement of the first developed appropriate countermeasure, using the fund created by Sec. 319- F(c)(10). CRS-33 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Counter -- Sec. 3 "Sec. 319A-1 (b)(2)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (b)(2)" Sec. 3 (a) "Sec. 319F-2 measure The HHS and DHS (c)(4)(B)" Same as S. 15 as Reported by (c)(4)(B)" Specifica- Secretaries will, to the extent Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by tions practicable, include in the Committee. Committee. proposal the estimated quantity and price of the future purchase, necessary measures of minimum safety and effectiveness, and any other information necessary to encourage and facilitate research, development, and manufacture of the countermeasure or to provide specifications for it. CRS-34 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Notifying Sec. 3 "Sec. 319A-1 (c)(3)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (c)(3)" Sec. 3 (a) "Sec. 319F-2 Potential If the President approves a (c)(4)(C)" Same as S. 15 as Reported by (c)(4)(C)" Developers proposal the DHS and HHS Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by Secretaries shall make known Committee. Committee. to persons who may respond to a call for the countermeasure involved -- the call for the Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by countermeasure; Committee. Committee. Committee. the required specifications Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by for the countermeasure; and Committee. Committee. Committee. a commitment for a the commitment described in Same as S. 15 as Reported by Same as H.R. 2122. recommendation for Sec. 3 (a) "Sec. 319F-2 Committee. procurement of the first such (c)(4)(A)" specific countermeasure that [see above] meets the conditions for procurement under subsection (d) and the specifications under Sec. 3 "Sec. 319A-1 (d)(2)" [see below] CRS-35 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Secretary's Sec. 3 "Sec. 319A-1 (d)(1)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (d)(1)" Sec. 3 (a) "Sec. 319F-2 Determina- The HHS Secretary, in (c)(5)(A)" Same as S. 15 as Reported by (c)(5)(A)" tion of consultation with the DHS The HHS Secretary, in Committee. Same as H.R. 2122. Counter -- Secretary, will determine if consultation with the DHS measures specific countermeasures are Secretary, will determine if Appropriate appropriate for procurement specific countermeasures are for Funding using the appropriations appropriate for procurement specified in Sec. 319A-1 (i). using the special reserve fund defined in Sec. 319F-2 (c)(10). CRS-36 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Secretary's Sec. 319A-1 (d)(2). Sec. 319F-2 (c)(5)(B). Sec. 319A-1 (d)(2). Sec. 3 (a) "Sec. 319F-2 Both H.R. Determina- For countermeasures to In making this determination Same as S. 15 as Reported by (c)(5)(B)" 2122 and S. tion of qualify for this funding the the HHS Secretary will Committee. Same as H.R. 2122. 15 as Counter -- HHS Secretary must determine and consider: Enacted measures determine: require the Appropriate Secretary for Funding (B)(i) quantities of the (i) Same as S. 15 as Reported Same as S. 15 as Reported by (i) Same as S. 15 as Reported only to (continued) product that will be needed by Committee. Committee. by Committee. consider for the SNS, whether products (B)(ii) feasibility of delivery (iii) Same as S. 15 as Same as S. 15 as Reported by (ii) feasibility of delivery of have other of sufficient quantities within Reported by Committee. Committee. sufficient quantities within significant five years, and eight years, and markets. This allows (C) that there is no (iii) whether there is a lack of Same as S. 15 as Reported by (iii) Same as H.R. 2122. procurement significant commercial a significant commercial Committee. of products market for the product, at the market for the product at that have time of this determination, time of procurement other another other than as a than as a countermeasure. market. countermeasure. This must be annually redetermined. CRS-37 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Presidential Sec. 3. "Sec. 319A-1 (e)" Sec. 3 (a) "Sec. 319F-2 Sec. 3. "Sec. 319A-1 (e)" Sec. 3 (a) "Sec. 319F-2 Approval (1) If a countermeasure is (c)(6)" Same as S.15 as Reported by (c)(6)" Required deemed appropriate, the HHS (A) If a countermeasure is Committee. Same as S.15 as Reported by for Procure- and DHS Secretaries, in deemed appropriate, the HHS Committee. ment coordination with the and DHS Secretaries, in Director of Office of coordination with the Management and Budget, Director of Office of will submit to the President a Management and Budget, proposal to procure the will submit to the President a countermeasure. proposal to procure the countermeasure using the special reserve fund defined in Sec. 319F-2 (c)(10). (2) Presidential approval is (B) Same as S. 15 as Same as S.15 as Reported by Same as S.15 as Reported by required to procure Reported by Committee. Committee. Committee. countermeasures under this act. CRS-38 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Notice to Sec. 3 "Sec. 319A-1 (e)(3)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (e)(3)" Sec. 3 (a) "Sec. 319F-2 Congress The DHS Secretary will (c)(6)(C)" Same as S.15 as Reported by (c)(6)(C)" notify Congress of each The HHS and DHS Committee. Same as H.R. 2122. presidential decision to Secretaries will notify approve the procurement of designated congressional countermeasures under this committees of each act. presidential decision to approve the use of the special reserve fund. This notice will include: No similar provision. an explanation of the No similar provision. Same as H.R. 2122. decision to use the special reserve fund, the potential countermeasure supplier or suppliers (when available), and whether other potential suppliers were considered and reasons for any rejection of them. CRS-39 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Subsequent Sec. 3 "Sec. 319A-1 (c)(4)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (c)(4)" Sec. 3 (a) "Sec. 319F-2 Specific Countermeasures developed (c)(6)(D)" Same as S.15 as Reported by (c)(6)(D)" Counter -- after a procurement can also Same as S.15 as Reported by Committee. Same as S.15 as Reported by measures be procured under this act if Committee. Committee. they represent an improvement over the original countermeasure. Examples of qualifying improvements are better safety or effectiveness. No similar provision. Determination of an No similar provision. Same as H.R. 2122. improvement is committed to agency discretion. Rule of No similar provision. Sec. 3 (a) "Sec. 319F-2 No similar provision. Sec. 3 (a) "Sec. 319F-2 Con- (c)(6)(E)" (c)(6)(E)" struction Recommendations and Same as H.R. 2122. approvals under Sec. 319F-2 (c)(6) are to the determination that the special reserve fund will be used for a procurement; not to the substance of contracts nor other matters relating to awards. CRS-40 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Interagency No similar provision. Sec. 3 (a) "Sec. 319F-2 No similar provision. Sec. 3 (a) "Sec. 319F-2 Agreements (c)(7)(A)-(B)" (c)(7)(A)-(B)" for Procure- The DHS Secretary will Same as H.R. 2122. ment reimburse the HHS Secretary for all costs of presidentially approved countermeasure procurements. Sec. 3 "Sec. 319A-1 However, the special reserve Same as S. 15 as Reported by Same as H.R. 2122. (i)(2)(C)" fund cannot be used to Committee. Funds appropriated under reimburse administrative this subsection cannot be costs. used for administrative costs. Procure- Sec. 3 "Sec. 319A-1 (f)(1)" Sec 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (f)(1)" Sec 3 (a) "Sec. 319F-2 ment The HHS Secretary is (c)(7)(C)(i)" Same as S. 15 as Reported by (c)(7)(C)(i)" responsible for arranging for Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by countermeasure procurement, Committee. Committee. including negotiating terms of (including quantity, production schedule, and price), and entering into, contracts and cooperative agreements, and for carrying out such other activities as may reasonably be required. The HHS Secretary will Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by promulgate any regulations Committee. Committee. Committee. necessary to implement these procurement provisions. CRS-41 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Contract Sec. 3 "Sec. 319A-1 (f)(2)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (f)(2)" Sec 3 (a) "Sec. 319F-2 Terms The procurement contracts (c)(7)(C)(ii)" Same as S. 15 as Reported by (c)(7)(C)(ii)" will include the following Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by terms: Committee. Committee. Payment conditioned on Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by delivery of a substantial Committee. Committee. Committee. portion of the number of contracted units. No similar provision. Up to a 10% advance No similar provision. Up to a 10% advance payment to ensure success of payment to ensure success of a project can be made at the a project can be made at the discretion of HHS Secretary. discretion of HHS Secretary. This advance payment must This advance payment must be refunded if the contractor be refunded if the contractor fails to perform under the fails to perform under the terms of the contract except terms of the contract. in special circumstances as determined by the Secretary. The contract period cannot The contract period cannot Same as S. 15 as Reported by Same as H.R. 2122. be longer than five years. be longer than five years, or Committee. up to eight years if the HHS Secretary determines at the time of initial award that a longer period is justified. CRS-42 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Contract Contracts may be renewed Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by Terms for additional periods of up Committee. Committee. Committee. (continued) to five years each. No similar provisions. The vendor must comply No similar provisions. Same as H.R. 2122. with all applicable export- related controls. The vendor must seek No similar provisions. Same as S. 15 as Reported by Same as S. 15 as Reported by approval, clearance or Committee. Committee. licensing of product. The HHS Secretary may waive this provision. CRS-43 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Contract The contract may specify: The contract may specify: The contract may specify: The contract may specify: Terms (continued) That the vendor must store Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by the countermeasure. In this Committee. Committee. Committee. case the special fund can be used to pay the vendor for the costs of shipping, handling, storage and related costs of the countermeasure a discounted price for a No similar provision. Same as S. 15 as Reported by Same as S. 15 as Reported by product that has not been Committee. Committee. licensed or approved at the time of delivery, and that the HHS Secretary may No similar provision. Same as S. 15 as Reported by No similar provision. terminate the contract for the Committee. failure to deliver a reasonable number (as determined by the Secretary) of units of product by three years after the contract commenced. CRS-44 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Availability Sec. 3 "Sec. 319A-1 (f)(3)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (f)(3)" Sec 3 (a) "Sec. 319F-2 of Simplified acquisition (c)(7)(C)(iii)(I)" Same as S. 15 as Reported by (c)(7)(C)(iii)(I)" Simplified procedures will apply to all Simplified acquisition Committee. Same as H.R. 2122. Acquisition countermeasure procedures will apply to Procedures procurements under this countermeasure section. procurements for which the HHS Secretary determines that there is pressing need. No similar provision. Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 Sec. 3 (a) "Sec. 319F-2 (c)(7)(C)(iii)(II)" (f)(3)(B)" (c)(7)(C)(iii)(II)" These purchases must These purchases must These purchases must comply with laws and comply with laws and comply with laws and regulations relating to regulations relating to regulations relating to contract work hours and contract work hours and contract work hours and safety standards, examination safety standards, examination safety standards, examination of contractor records, and the of contractor records, the of contractor records, the Anti-Kickback Act. Anti-Kickback Act, bonds of Anti-Kickback Act, bonds of contractors of public contractors of public buildings, limits on buildings, middlemen fees, subcontractor sales, the Solid Waste Disposal Act, middlemen fees, and and veterans' employment veterans' employment reporting requirements. reporting requirements. No similar provision. No similar provision. No similar provision. Sec 3 (a) "Sec. 319F-2 (c)(7)(C)(iii)(III)" The Secretary shall establish appropriate internal controls for procurements under this clause. CRS-45 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Authority to No similar provision. No similar provision. No similar provision. Sec. 3 (a) ""Sec. 319F-2 Limit (c)(7)(C)(iii)(IV)" Competition If the Secretary determines that the mission of the BioShield Program under the Project BioShield Act of 2004 would be seriously impaired by fair and open competition, the Secretary may conduct a procurement using other than fair and open competition. Use of Sec. 3 "Sec. 319A-1 (f)(4)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (f)(4)" Sec. 3 (a) "Sec. 319F-2 Procedures Authorizes the use of (c)(7)(C)(iv)" Same as S. 15 as Reported by (c)(7)(C)(iv)" Other than noncompetitive procedures to Authorizes the use of other Committee. Same as H.R. 2122. Full and procure a product available than competitive procedures Open from a limited number of to procure a product Competition responsible sources. available from a limited number of responsible sources. CRS-46 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Use of No similar provision. The Secretary shall No similar provision. The Secretary shall Procedures implement this clause in implement this clause in Other than accordance with accordance with Full and government-wide regulations government-wide regulations Open including requirements that including requirements that Competition offers be solicited from as offers be solicited from as (continued) many potential sources as is many potential sources as is practicable under the practicable under the circumstances, that required circumstances, that required notices be published, and that notices be published, and that submitted offers be submitted offers be considered. considered, as such regulations apply to procurements for which an agency has authority to use procedures other than competitive procedures when the property or services needed by the agency are available from only one responsible source or only from a limited number of responsible sources and no other type of property or services will satisfy the needs of the agency. CRS-47 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Premium Sec. 3 "Sec. 319A-1 (f)(5)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (f)(5)" Sec. 3 (a) "Sec. 319F-2 Provision in The HHS Secretary may (c)(7)(C)(v)" Same as S. 15 as Reported by (c)(7)(C)(v)" Multiple enter into contracts for a Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by Award single countermeasure with Committee. Committee. Contracts more than one vendor. In these cases contracts may be constructed to award a greater share of the procurement to the first vendor to successfully meet the terms of the contract. Determinations of the Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by success of meeting all of the Committee. Committee. Committee. requirements by the HHS Secretary are committed to agency discretion. Extension of Sec. 3 "Sec. 319A-1 (f)(6)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (f)(6)" Sec. 3 (a) "Sec. 319F-2 Closing A decision by the HHS (c)(7)(C)(vi)" Same as S. 15 as Reported by (c)(7)(C)(vi)" Date for Secretary to extend the Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by Receipt of closing date for receipt of Committee. Committee. Proposals is proposals for a procurement not is committed to agency Reviewable discretion. CRS-48 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Limiting Sec. 3 "Sec. 319A-1 (f)(7)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (f)(7)" Sec. 3 (a) "Sec. 319F-2 Competition The HHS Secretary may (c)(7)(C)(vii)" Same as S. 15 as Reported by (c)(7)(C)(vii)" to Sources stipulate that all potential Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by Responding sources must provide, on Committee. Committee. to request, information that Information would allow the HHS to use Requests advance procurement planning or market research. Vendors who do not provide such information can be excluded from consideration. Interagency Sec. 3 "Sec. 319A-1 (g)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (g)" Sec. 3 (a) "Sec. 319F-2 Agreements HHS and DHS Secretaries (c)(8)" Same as S. 15 as Reported by (c)(8)" may enter into interagency Same as S. 15 as Reported by Committee. Same as S. 15 as Reported by agreements with other Committee. Committee. federal agencies to facilitate procuring these countermeasures. Only the DHS and HHS Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by Secretaries may exercise the Committee. Committee. Committee. authorities provided by this section. CRS-49 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Restrictions Sec. 3 "Sec. 319A-1 (i)(2)" Sec. 3 (a) "Sec. 319F-2 Sec. 3 "Sec. 319A-1 (i)(2)" Sec. 3 (a) "Sec. 319F-2 on Use of Amounts appropriated under (c)(9)" Same as S. 15 as Reported by (c)(9)" Funds this Act cannot be used to The special reserve fund Committee. Same as H.R. 2122. pay for: cannot be used to pay for: (A) vaccines under (A) vaccines under Same as S. 15 as Reported by Same as H.R. 2122. procurement contracts procurement contracts Committee. entered into before January entered into before the 1, 2003, or enactment of this Act or (B) new contracts or No similar provision. Same as S. 15 as Reported by No similar provision. obligations for procuring a Committee. countermeasure after a determination that it has significant commercial market other than as a countermeasure and; (C) administrative costs. (B) Same as S. 15 as Same as S. 15 as Reported by (B) costs other than Reported by Committee. Committee. payments made by the Secretary to a vendor for a procurement of a security countermeasure under Sec. 319F-2 (c)(7). CRS-50 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Definitions No similar provision. Sec. 3 (a) "Sec. 319F-2 No similar provision. Sec. 3 (a) "Sec. 319F-2 (c)(10)(A)" (c)(10)(A)" Special reserve fund in this Same as H.R. 2122. section has the same meaning as special reserve fund in Sec. 510 of the Homeland Security Act of 2002 (6 U.S.C. 311 et seq.) No similar provision. Designates specific No similar provision. Designates specific congressional committees for congressional committees for reporting purposes: reporting purposes: In the House of Same as H.R. 2122. Representatives: the Committee on Energy and Commerce, the Committee on Appropriations, the Committee on Government Reform, and the Select Committee on Homeland Security (or any successor to the Select Committee). In the Senate: the Committee In the Senate: the on Health, Education, Labor, appropriate committees. and Pensions, the Committee on Appropriations, and the Committee on Government Affairs. CRS-51 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Definitions Sec. 3 "Sec. 319A-1 (h)(2)" Sec. 2 (e). Sec. 3 "Sec. 319A-1 (h)(2)" Sec. 2 (a) "Sec. 319F-1 (continued) Defines biomedical The PHSA, as modified by Same as S. 15 as Reported by (a)(2)" and Sec. 2 (d) countermeasure as a drug, this legislation, defines a Committee. Same as S. 15 as Reported by biological product, or device countermeasure as a drug, Committee. used: biological product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that can be used (1) to treat, identify, or (1) to treat, identify, or Same as S. 15 as Reported by Same as S. 15 as Reported by prevent harm from any prevent infection by a Committee. Committee. CBRN agent that may cause biological agent or toxin or a public health emergency harm from any other agent affecting national security; or that may cause a public health emergency; or (2) to treat, identify, or (2) Same as S. 15 as Same as S. 15 as Reported by Same as S. 15 as Reported by prevent harm from a Reported by Committee. Committee. Committee. condition that may result in adverse health consequences or death and may be caused by the administering of a countermeasure described in (1). CRS-52 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Technical No similar provision. Sec. 3 (a) "Sec. 319F-2 (d- No similar provision. Sec. 3 (a) "Sec. 319F-2 (d- Amend- f)" f)" ments These subsections make Same as H.R. 2122. technical amendments required by the transfer of the SNS from the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to the PHSA. Amendment No similar provision. Sec. 3 (b) No similar provision. Sec. 3 (b) to No similar provision. (1) Amends Homeland Homeland Security Act (P.L. 107-296) Security Act to be consistent with the transfer of the Strategic National Stockpile to the direct control of the HHS Secretary. Adds to the Homeland Same as H.R. 2122. Security Act of 2002 (P.L. 107-296, 6 U.S.C. 311 et seq.) "Sec. 510 Procurement of Security Countermeasures for the Strategic National Stockpile." CRS-53 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Appropri- Sec. 3 "Sec. 319A-1 (i)" Sec. 3 (b) "Sec. 510 (a)" Sec. 3 "Sec. 319A-1 (i)" Sec. 3 (b) "Sec. 510 (a)" The 2004 ation Appropriates, out of any Authorizes the appropriation Authorizes the appropriation Same as H.R. 2122. DHS Authoriza- moneys in the Treasury not of up to $5.593 billion for of up to $5.593 billion for Appropri- tion otherwise appropriated, for FY2004-2013 for FY2004-2013 for ations Act FY2003 and for each fiscal presidentially approved presidentially approved (P.L. 108-90) year thereafter, such sums as countermeasures. countermeasures. appropriated may be necessary for the $5.593 costs incurred by the HHS billion for Secretary in the procurement FY2004- of presidentially approved FY2013 for countermeasures. "Biodefense Counter- Of this total, not more than Of this total, not more than Same as H.R. 2122. measures" $3.418 billion may be $3.418 billion may be with obligated for FY2004-2008 authorized for FY2004-2008 identical and not more than $890 and not more than $890 obligation million for FY2004. This million for FY2004. constraints. money goes into the special reserve fund as defined in Sec. 510 (b). Definition of No similar provision. Sec. 3 (b) "Sec. 510 (b)" No similar provision. Sec. 3 (b) "Sec. 510 (b)" S. 15 as Special Special reserve fund means Special reserve fund means Enacted uses Reserve the appropriations account the "Biodefense the identical Fund established as a result of any Countermeasures" language appropriations made under appropriations account or used in the Sec. 510 (a). any other appropriation made 2004 DHS under Sec. 510 (a). Appropria- tions Act. CRS-54 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Limits on No similar provision. Sec. 3 (b) "Sec. 510 (c)" No similar provision. Sec. 3 (b) "Sec. 510 (c)" Special (1) It is the intent of the No similar provision. Reserve Congress that unobligated Fund amounts in this fund will not be applied, through reprogramming or otherwise, to any other purpose. No similar provision. (2)Appropriations to the No similar provision. Same as H.R. 2122. special reserve fund are available to be obligated through FY2013 and only for presidentially approved countermeasures. CRS-55 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Related No similar provision. Sec. 3 (b) "Sec. 510 (d)(1)" No similar provision. Sec. 3 (b) "Sec. 510 (d)(1)" Appropria- Authorizes the appropriation Authorizes the appropriation tion of $5 million for FY2003 and of such sums as may be Authoriza- such sums as may be necessary for FY2004-2006 tions necessary for FY2004-2006 for the hiring of CBRN for the hiring of Chemical, threat assessment analysts Biological, Radiological, and within the DHS IAIP. Nuclear (CBRN) threat assessment analysts within the DHS Directorate for Information Analysis and Infrastructure Protection (IAIP). No similar provision. Sec. 3 (b) "Sec. 510 (d)(2)" No similar provision. Sec. 3 (b) "Sec. 510 (d)(2)" Authorizes the appropriation Authorizes the appropriation of such sums as may be of such sums as may be necessary for FY2003- necessary for FY2004- FY2006 for the acquisition FY2006 for the acquisition and deployment of secure and deployment of secure facilities to permit the DHS facilities to permit the DHS Secretary to receive (by the Secretary to receive (not end of 2003) all classified later than 180 days after information and products to enactment) all classified which the Undersecretary for information and products to IAIP is entitled. which the Undersecretary for IAIP is entitled. CRS-56 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Stockpile No similar provision. No similar provision. No similar provision. Sec. 3 (c) Functions The functions, personnel, Transferred assets, unexpended balances, From DHS and liabilities of the Strategic Secretary to National Stockpile are HHS transferred from the DHS Secretary Secretary to the HHS Secretary. Exceptions: Duties of the DHS Secretary described in this act and the "Biodefense Countermeasure" funds appropriated in the 2004 DHS Appropriations Act (P.L. 108-90) are not transferred. CRS-57 Table 4. Authorization for Medical Products for Use in Emergencies Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Sec. 4 Sec. 4 Sec. 4 Sec. 4 Authorization for Medical Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by Products for Use in Committee. Committee. Committee. Emergencies. Amends Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) by adding "Sec. 564. Authorization for Medical Products for Use in Emergencies." Authoriza- Sec. 4 (a) "Sec. 564 (a)" Sec. 4 (a) "Sec. 564 (a)" Sec. 4 (a) "Sec. 564 (a)" Sec. 4 (a) "Sec. 564 (a)" tion to The HHS Secretary may Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by Allow the authorize the temporary Committee. Committee. Committee. Emergency introduction into interstate Use of a commerce, of a drug, device, Counter- or biological product measure intended for use in an actual or potential emergency. CRS-58 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Approval No similar provision. Sec. 4 (a) "Sec. 564 (a)(2)" No similar provision. Sec. 4 (a) "Sec. 564 (a)(2)" Status of The HHS Secretary may Same as H.R. 2122. Product make emergency use authorizations for products that are not approved, licensed, or cleared for commercial distribution (unapproved products) and for products that are approved for other uses (unapproved use of an approved product). Relation to No similar provision. Sec. 4 (a) "Sec. 564 (a)(3)" No similar provision. Sec. 4 (a) "Sec. 564 (a)(3)" Other Uses Emergency use Same as H.R. 2122. authorizations are in addition to any other approved uses of the product. CRS-59 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Definitions No similar provision. Sec. 4 (a) "Sec. 564 (a)(4)" No similar provision. Sec. 4 (a) "Sec. 564 (a)(4)" The PHSA Biological product has the Same as H.R. 2122. defines meaning given in sec. 351 of biological the PHSA. product as "a virus, Emergency use means the Same as H.R. 2122. therapeutic use of a product during an serum, toxin, actual emergency or potential antitoxin, emergency. vaccine, blood, blood Product means a drug, device Same as H.R. 2122. component or biological product. or derivative, allergenic An unapproved product is a Same as H.R. 2122. product, or product without approval, analogous license, or clearance for product, or ... commercial distribution. any trivalent organic An unapproved use of an Same as H.R. 2122. arsenic approved product is the use compound, of a product that is not applicable to approved for that use but has the been approved for another prevention, use. treatment, or cure of a disease or condition of human beings." CRS-60 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Emergency Sec. 4 (a) "Sec. 564 (b)(1)" Sec. 4 (a) "Sec. 564 (b)(1)" Sec. 4 (a) "Sec. 564 (b)(1)" Sec. 4 (a) "Sec. 564 (b)(1)" Declaration The HHS Secretary may The HHS Secretary may The HHS Secretary may The HHS Secretary may declare an emergency if: declare an emergency if: declare an emergency if: declare an emergency if: (A) The Homeland Security (A) The Homeland Security Same as S. 15 as Reported by Same as S. 15 as Reported by (DHS) Secretary determines (DHS) Secretary determines Committee. Committee. that there is a domestic that there is a national emergency or significant emergency or significant potential for one involving potential for one involving the heightened risk of attack the heightened risk of attack with a specified biological, with a specified biological, chemical, radiological or chemical, radiological or nuclear (CBRN) agent, or nuclear (CBRN) agent, or (B) The Defense Secretary (B) The Defense Secretary Same as S. 15 as Reported by Same as S. 15 as Reported by determines that there is a determines that there is a Committee. Committee. military emergency or military emergency or significant potential for one significant potential for one involving the heightened risk involving the heightened risk to U.S. military forces of to U.S. military forces of attack with a CBRN agent, or attack with a specified CBRN agent, or CRS-61 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Emergency (C) the HHS Secretary Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by Declaration determines that there is a Committee. Committee. Committee. (continued) public health emergency under Section 319 of the PHSA affecting national security and involving a specified CBRN agent, or a specified disease or condition that may be attributable to such agent. Declaration Sec. 4 (a) "Sec. 564 Sec. 4 (a) "Sec. 564 Sec. 4 (a) "Sec. 564 Sec. 4 (a) "Sec. 564 Termination (b)(2)(A)" (b)(2)(A)" (b)(2)(A)" (b)(2)(A)" An emergency declaration Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by will terminate on the earlier Committee. Committee. Committee. of: (i) a determination by the HHS Secretary, in consultation with the DHS Secretary or Defense Secretary that the circumstances requiring the declaration no longer exist, or (ii) one year from the declaration date. CRS-62 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Declaration Sec. 4 (a) "Sec. 564 Sec. 4 (a) "Sec. 564 Sec. 4 (a) "Sec. 564 Sec. 4 (a) "Sec. 564 Renewal (b)(2)(B)" (b)(2)(B)" (b)(2)(B)" (b)(2)(B)" The HHS Secretary may Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by renew a declaration. Committee. Committee. Committee. Renewed declarations will be subject to termination under the above conditions and may also be renewed. Disposition No similar provision. No similar provision. No similar provision. Sec. 4 (a) "Sec. 564 of Product (b)(2)(C)" If an emergency use authorization of an unapproved product is terminated, the Secretary shall consult with the manufacturer of such product with respect to the appropriate disposition of the product. CRS-63 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Advance No similar provision. Sec. 4 (a) "Sec. 564 (b)(3)" No similar provision. Sec. 4 (a) "Sec. 564 (b)(3)" Notice of The HHS Secretary must Same as H.R. 2122. Termination provide advanced notification that the declaration will be terminated to allow enough time to: (A) allow removal of unapproved products from distribution channels and (B) allow labeling changes for products used for unapproved uses. Publication Sec. 4 (a) "Sec. 564 (b)(3)" Sec. 4 (a) "Sec. 564 (b)(4)" Sec. 4 (a) "Sec. 564 (b)(3)" Sec. 4 (a) "Sec. 564 (b)(4)" H.R. 2122 The HHS Secretary must The HHS Secretary must Same as S. 15 as Reported by The HHS Secretary must Sec. 5 publish in the Federal publish in the Federal Committee. publish in the Federal (a)(1)(A)(iii) Register and notify the Register each declaration, Register each declaration, (II) requires appropriate congressional determination and renewal. determination, advanced an annual committees of each notice of termination, and report to declaration, determination renewal. Congress and renewal. detailing any such declaration. See below. CRS-64 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Emergency Sec. 4 "Sec. 564 (c)" Sec. 4 "Sec. 564 (c)" Sec. 4 "Sec. 564 (c)" Sec. 4 "Sec. 564 (c)" Authoriza- The HHS Secretary may The HHS Secretary may Same as S. 15 as Reported by Same as H.R. 2122. tion Criteria authorize the emergency use authorize the emergency use Committee. of a product only if the of a product only if, after Secretary concludes -- consultation with the Director of the National Institutes of Health and the Director of the Centers for Disease Control and Prevention, the Secretary concludes -- (1) that an agent specified in Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by the emergency declaration Committee. Committee. Committee. can cause a serious or life- threatening disease or condition; (2) that, based on the totality Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by of scientific evidence Committee. Committee. Committee. available to the Secretary, it is reasonable to believe that -- Same as S. 15 as Reported by Same as S. 15 as Reported by (A) the product may be (A) the product may be Committee. Committee. effective in diagnosing, effective in detecting, treating, or preventing a life- diagnosing, treating, or threatening disease or preventing a life-threatening condition caused by that disease or condition caused agent or by a countermeasure by that agent or by a against that agent; and countermeasure against that CRS-65 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Emergency (B) the known and potential Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by Authoriza- benefits of the product Committee. Committee. Committee. tion Criteria outweigh its known and (continued) potential risks. (3) that there is no adequate, Same as S. 15 as Reported by Same as S. 15 as Reported by (3) that there is no adequate, approved, and available Committee. Committee. approved, and available alternative to the product for alternative to the product for detecting, diagnosing, diagnosing, preventing, or preventing, or treating such treating such disease or disease or condition; and condition; and (4) that such other criteria as Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by the Secretary may by Committee. Committee. Committee. regulation prescribe are satisfied. CRS-66 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Emergency Sec. 4 "Sec. 564 (d)" Sec. 564 (d)(1). Sec. 4 "Sec. 564 (d)" Sec. 4 (a) "Sec. 564 (d)" Authoriza- An authorization of a product Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by tion Scope under this section shall state Committee. Committee. Committee. -- (A) each disease or condition (1)Same as S. 15 as Reported (1) Same as S. 15 as (1) each disease or condition for which the product may be by Committee. Reported by Committee. and the intended use of the used within the scope of the product within the scope of authorization; the authorization; and (B) the Secretary's No similar provision. (2) Same as H.R. 2122 No similar provision. conclusions, that the known and potential benefits of the product, outweigh the known and potential risks of the product; and (C) Same as S. 15 as (2) Same as S. 15 as (3) the Secretary's (2) the Secretary's Reported by Committee. Reported by Committee. conclusions, concerning the conclusions, concerning the safety and potential safety and potential effectiveness of the product effectiveness of the product in diagnosing, preventing, or in detecting, diagnosing, treating such diseases or preventing, or treating such conditions, including an diseases or conditions, assessment of the available including an assessment of scientific evidence. the available scientific evidence. CRS-67 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Confidential No similar provision. Sec. 564 (d)(2). No similar provision. No similar provision. These Information Nothing in this section alters sections of or amends 18 U.S.C. 1905 or the United 5 U.S.C. 552(b)(4). States Code require the confidential handling of financial information of any person, firm, partnership, corporation, association. This includes trade secrets and information on processes and operations. CRS-68 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Required Sec. 4 "Sec. 564 (e)" Sec. 4(a) "Sec. 564 Sec. 4 "Sec. 564 (e)" Sec. 4(a) "Sec. 564 Conditions The HHS Secretary will (e)(1)(A)" Same as S. 15 as Reported by (e)(1)(A)" on impose requirements With respect to emergency Committee. With respect to emergency Unapproved (including requirements use of an unapproved use of an unapproved Product concerning product labeling product, the HHS Secretary product, the HHS Secretary Emergency and the provision of will establish authorization will establish authorization Authoriza- information) designed to conditions to protect public conditions to protect public tion ensure that -- health including -- health including -- (1) to the extent feasible, (i) to the extent feasible, Same as S. 15 as Reported by (i) to the extent practical, ensuring those administering ensuring that those Committee. ensuring that those the countermeasure know administering the administering the that the Secretary has countermeasure know countermeasure know that authorized the product solely that the Secretary has the Secretary has authorized for emergency use, the authorized the emergency use the emergency use of the significant known and of the product, the significant product, the significant potential benefits and risks of known and potential benefits known and potential benefits the product (and the extent to and risks of the product (and and risks of the product (and which these are unknown), the extent to which these are the extent to which these are and of any available unknown), and of any unknown), and of any alternatives and their risks available alternatives and available alternatives and and benefits. their risks and benefits. their risks and benefits. CRS-69 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Required (2) to the extent feasible, (ii) to the extent feasible, (2) Same as S. 15 as (ii) to the extent practical, Conditions (including requirements ensuring that those receiving Reported by Committee. ensuring that those receiving on concerning product labeling the product know -- the product know -- Unapproved and the provision of Product information) ensuring that Emergency those receiving the product Authoriza- know -- tion (continued) that the Secretary has that the Secretary has Same as S. 15 as Reported by that the Secretary has authorized the product solely authorized the emergency use Committee. authorized the emergency use for emergency use, the of the product, the significant of the product, the significant significant known and known and potential benefits known and potential benefits potential benefits and risks of and risks of the product (and and risks of the product (and the product (and the extent to the extent to which these are the extent to which these are which these are unknown), of unknown), of any available unknown), of any available any available alternatives and alternatives and their risks alternatives and their risks their risks and benefits, and and benefits, and of the and benefits, and of the of the option to accept or option to accept or refuse option to accept or refuse refuse administration of the administration of the product administration of the product product and any and any consequences of and any consequences of consequences of doing so; doing so; doing so; Sec. 4 "Sec. 564 (e)(8)" (iii) appropriate conditions Sec. 4 "Sec. 564 (e)(8)" (iii) Same as H.R. 2122. Same as H.R. 2122. for the monitoring and Same as H.R. 2122. reporting of adverse events associated with use of the product; CRS-70 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Required Sec. 4 "Sec. 564 (e)(6)" (iv) For manufacturers of the Sec. 4 "Sec. 564 (e)(6)" (iv) Same as H.R. 2122. Conditions Requirements concerning product, appropriate Same as S. 15 as Reported by on recordkeeping and reporting, conditions concerning record Committee. Unapproved including records access by keeping and reporting Product the Secretary and publication including records access by Emergency of data. the Secretary. Authoriza- tion (continued) CRS-71 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Optional Sec. 4 "Sec. 564 (e)" Sec. 4 (a) "Sec. 564 Sec. 4 "Sec. 564 (e)" Sec. 4 (a) "Sec. 564 S. 15 as Conditions The HHS Secretary is (e)(1)(B)" Same as S. 15 as Reported by (e)(1)(B)" Reported by on authorized to impose such With respect to emergency Committee. With respect to the Committee Unapproved conditions on an use of an unapproved emergency use of an and Product authorization as the product, The HHS Secretary unapproved product, the S. 1504 do Emergency Secretary determines are may establish additional Secretary may, for a person not Authoriza- necessary to protect public conditions on authorizations who carries out any activity distinguish tion health including -- to protect public health for which the authorization is between including -- issued, establish such unapproved conditions on an products and authorization under this unapproved section as the Secretary finds uses of necessary or appropriate to approved protect the public health, products. including the following: (3) impose limitations on (i) on which entities may (3) Same as S. 15 as (i) Same as H.R. 2122. which entities may distribute distribute the product for Reported by Committee. the product for emergency emergency use and on how use and on how distribution distribution is to be is to be performed; performed; (4) impose limitations on (ii) on who may administer (4) Same as H.R. 2122. (ii) Same as H.R. 2122. who may administer the the product for emergency product for emergency use, use, and on the categories of and on the categories of individuals to whom, and the individuals to whom, and the circumstances under which, circumstances under which, the product may be the product may be administered.; administered; CRS-72 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Optional No similar provision. No similar provision. No similar provision. (iii) Appropriate conditions S. 15 as Conditions with respect to the collection Reported by on and analysis of information, Committee Unapproved during the period when the and Product authorization is in effect, S. 1504 Emergency concerning the safety and require the Authoriza- effectiveness of the product imposition of tion with respect to its emergency record- (continued) use; keeping require- (5) condition the No similar provision. (5) Same as S. 15 as No similar provision. ments. authorization on the Reported by Committee. H.R. 2122 performance of studies, and S. 15 as clinical trials, or other enacted research needed to support permit but do marketing approval of the not require product. such require- ments. (6) The Secretary shall (iii) for persons other than (6) Same as S. 15 as (iv) Same as H.R. 2122. impose, to the extent feasible manufacturers of the Reported by Committee. and appropriate, product, appropriate requirements concerning conditions concerning recordkeeping and reporting, recordkeeping and reporting, including records access by including records access by the Secretary and publication the Secretary with respect to of data. the emergency use of the product. CRS-73 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Optional (7) The HHS Secretary may (iv) with respect to the (7) Same as S. 15 as Sec. 4 (a) "Sec. 564 (e)(3)" The FFDCA Conditions waive, to the extent emergency use of the Reported by Committee. Same as H.R. 2122. Sec. 501 on appropriate given the product, waive or limit, to defines Unapproved circumstances of the the extent appropriate given adulterated Product emergency, requirements, the circumstances of the drugs and Emergency with respect to the product, emergency, conditions devices. Authoriza- of current good regarding current good tion manufacturing practice manufacturing practice (continued) otherwise applicable to the otherwise applicable to the manufacture, processing, manufacture, processing, packing, or holding of packing, or holding of these products subject to regulation products subject to regulation under this act. under this act, including such requirements established in section 501 of the Federal Food, Drug, and Cosmetic Act (FFDCA). CRS-74 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Unapproved Sec. 4 "Sec. 564 (e)(1-8)" Sec. 4 (a) "Sec. 564 (e)(2)" Sec. 564 (e)(1-8). Sec. 4 (a) "Sec. 564 (e)(2)" S. 15 as Use See above. For unapproved use of an See above. Same as H.R. 2122. Reported by Emergency approved product Committee Authoriza- authorization: and tion S. 1504 do Conditions See above. The Secretary may, for See above. For a manufacturer of the not manufacturers of the product product who carries out any distinguish who choose to carry out one activity for which the between or more activities for which authorization is issued, the unapproved the authorization is issued, Secretary shall, to the extent products and establish any of the practicable given the unapproved conditions described in circumstances of the uses of clauses Sec. 564 (e)(1)(A)(i - emergency, establish approved iv) conditions described in products. clauses (i) and (ii) of Sec. 564 (e)(1)(A) (1)(A), and may establish conditions described in clauses (iii) and (iv) of such paragraph. No similar provision. (i) If the manufacturer of the No similar provision. (i) Same as H.R. 2122. product chooses not to make an authorized change to the product label to reflect the emergency authorization, the authorization may not allow the product distributors or any other person to alter or obscure the labeling provided by the manufacturer. CRS-75 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Unapproved No similar provision. (ii) In the circumstances No similar provision. (ii) In the circumstances Use described in clause (i), an described in clause (i), for a Emergency authorization under this person who does not Authoriza- section regarding the manufacture the product and tion emergency use may, for who chooses to act under this Conditions persons who do not clause, an authorization (continued) manufacture the product and under this section regarding who choose to act under this the emergency use shall, to clause, authorize such the extent practicable, persons to provide authorize such person to information on the product in provide appropriate addition to the labeling information with respect to provided by the such product in addition to manufacturer, subject to the labeling provided by the compliance with clause (i). manufacturer, subject to Such additional information compliance with clause (i). shall not be considered While the authorization labeling for purposes of under this section is effective, section 502. such additional information shall not be considered labeling for purposes of section 502. CRS-76 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Unapproved No similar provision. No similar provision. No similar provision. Sec. 4 (a) "Sec. 564 (e)(4)" Use The Secretary may establish Emergency conditions on advertisements Authoriza- and other promotional tion descriptive printed matter Conditions that relate to the emergency (continued) use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product) Emergency Sec. 4 "Sec. 564 (f)" Sec. 4 "Sec. 564 (f)" Sec. 4 "Sec. 564 (f)" Sec. 4 "Sec. 564 (f)" Use Emergency authorizations Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by Authoriza- will continue until the earlier Committee. Committee. Committee. tion of a termination of the Duration emergency declaration or a revocation of emergency use authorization by the HHS Secretary under Sec. 564 (g). After authorization Same as S. 15 as Reported by Same as S. 15 as Reported by After authorization terminates, patients already Committee. Committee. terminates, patients already receiving the product may receiving the product may continue to do so for as long continue to do so for as long as is deemed necessary by as is deemed necessary by the patients' attending the patient's attending physicians. physician. CRS-77 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Emergency Sec. 4 (a) "Sec. 564 (g)" Sec. 4 (a) "Sec. 564 (g)" Sec. 4 (a) "Sec. 564 (g)" Sec. 4 (a) "Sec. 564 (g)" Use The HHS Secretary will Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by Authoriza- periodically review the Committee. Committee. Committee. tion circumstances and Revocation appropriateness of these emergency use authorizations. The HHS Secretary may The HHS Secretary may Same as S. 15 as Reported by Same as S. 15 as Reported by revoke an authorization if the revoke an authorization if the Committee. Committee. authorization criteria under authorization criteria under Sec. 564 (c) are no longer Sec. 564 (c) are no longer met or other circumstances met. make such a revocation appropriate. This decision is not Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by reviewable. Committee. Committee. Committee. CRS-78 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Publication Sec. 4 (a) "Sec. 564 (h)" Sec. 4 (a) "Sec. 564 (h)" Sec. 4 (a) "Sec. 564 (h)" Sec. 4 (a) "Sec. 564 (h)" H.R. 2122 The HHS Secretary will The Secretary shall promptly Same as S. 15 as Reported by The Secretary shall promptly Sec. 5 promptly publish in the publish in the Federal Committee. publish in the Federal (a)(1)(A)(iii) Federal Register, and provide Register a notice of each Register a notice of each (I) requires to the appropriate authorization, and each authorization, and each an annual congressional committees, a termination or revocation of termination or revocation of report to notice of each authorization, an authorization, and an an authorization under this Congress authorization termination and explanation of the reasons section, and an explanation detailing authorization revocation. therefor, under this section. of the reasons therefor such (which may include a authoriza- summary of data or tions. information that has been See below. submitted to the Secretary in an application under section 505(i) or section 520(g), even if such summary may indirectly reveal the existence of such application). No similar provision. No similar provision. No similar provision. Nothing in this section alters or amends section 1905 of title 18, United States Code, or section 552(b)(4) of title 5 of such Code. CRS-79 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Record- Sec. 4 (a) "Sec. 564 (i)(1)" No similar provision. Sec. 4 (a) "Sec. 564 (i)(1)" No similar provision. keeping The HHS Secretary may Same as S. 15 as Reported by require persons, including a Committee. person who holds an authorization under this section, or who manufactures, distributes, prescribes, or administers a product that is the subject of such an authorization, to establish and maintain -- data that is obtained from No similar provision. Same as S. 15 as Reported by No similar provision. such activity and that Committee. pertains to the effectiveness or safety of such product; such records as are necessary No similar provision. Same as S. 15 as Reported by No similar provision. to determine, or facilitate a Committee. determination, whether there may be any violation of this section or of a regulation promulgated under this section; and such additional records as the No similar provision. Same as S. 15 as Reported by No similar provision. Secretary may determine Committee. necessary. CRS-80 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Access to Sec. 4 (a) "Sec. 564 (i)(2)" No similar provision. Sec. 4 (a) "Sec. 564 (i)(2)" No similar provision. Records by The HHS Secretary may Same as S. 15 as Reported by HHS require a person who holds Committee. Secretary an authorization under this section, or who manufactures, distributes, prescribes, or administers a product that is the subject of such an authorization, to provide to the Secretary all data that is obtained from such activity and that pertains to the safety or effectiveness of such product. Every person required under No similar provision. Same as S. 15 as Reported by No similar provision. this section to establish or Committee. maintain records, and every person in charge or custody of such records, shall, upon request by the Secretary, permit the Secretary at all reasonable times to have access to, to copy, and to verify such records. CRS-81 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Actions Sec. 4 (a) "Sec. 564 (k)" Sec. 4 (a) "Sec. 564 (i)" Sec. 4 (a) "Sec. 564 (k)" Sec. 4 (a) "Sec. 564 (i)" Committed All HHS Secretary, Defense Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by to Agency Secretary and DHS Secretary Committee. Committee. Committee. Discretion actions under the authority of this section are committed to agency discretion. Regulations Sec. 4 (a) "Sec. 564 (l)" No similar provision. Sec. 4 (a) "Sec. 564 (l)" No similar provision. The HHS Secretary may Same as S. 15 as Reported by promulgate regulations to Committee. implement this section. CRS-82 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Rules of Sec. 4 (a) "Sec. 564 (m)" Sec 4 (a) "Sec. 564 (j)" Sec. 4 (a) "Sec. 564 (m)" Sec 4 (a) "Sec. 564 (j)" Con- Nothing in this section shall Same as S. 15 as Reported by Same as S. 15 as Reported by Nothing in this section struction be construed to impair or Committee. Committee. impairs the authority of -- otherwise affect the authority of -- the President as Commander Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by in Chief of the Armed Forces Committee; Committee; Committee; of the United States; the Secretary of Defense with Same as S. 15 as Reported by Same as S. 15 as Reported by Same as S. 15 as Reported by respect to the Department of Committee; Committee. Committee; Defense, including the armed forces, under other provisions of Federal law. No similar provision. or the HHS Secretary under No similar provision. the United States to use or section 319F-2 of the Public manage quantities of a Health Services Act to product that are owned or manage the stockpile under controlled by the United such section. States (including quantities in the stockpile maintained under section 319F-2 of the Public Health Service Act). CRS-83 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Application Sec. 4 (a) "Sec. 564 (n)(1)" Sec. 4 (a) "Sec. 564 (k)(1)" Sec. 4 (a) "Sec. 564 No similar provision. Similar to Members With respect to members of Same as S. 15 as Reported by (n)(1)(A)" provisions of the the armed forces, the Committee. Same as S. 15 as Reported by were enacted Armed President may waive any Committee. by the Forces requirement designed to National ensure that individuals are Defense informed of an option to Authoriza- accept or refuse the product tion Act for if the President determines, Fiscal Year in writing, that complying 2004 with such requirement is not (P.L.108- feasible, is contrary to the 136) best interests of the members Sec. 1603 (b) affected, or is not in the (10 U.S.C. interests of national security. 1107a). CRS-84 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Application No similar provision. Sec. 4 (a) "Sec. 564 (k)(2)" Sec. 4 (a) "Sec. 564 No similar provision. 10 U.S.C. to Members If the HHS Secretary (n)(1)(B)" 1107 of the determines that it is not Same as H.R. 2122. addresses the Armed feasible to provide a member procedures Forces of the armed forces required for (continued) information required by Sec. using 564 (e)(1)(A)(ii) [see above] investiga- prior to the use of the tional new product, such information drugs (IND) will be provided to the on the individual or next-of-kin as members of soon as possible and within the armed 30 days of use. This services. information must be recorded Among other in the medical record of the provisions, it member. requires notification Sec. 4 (a) "Sec. 564 (n)(2)" Sec. 4 (a) "Sec. 564 (k)(3)" Sec. 4 (a) "Sec. 564 (n)(2)" No similar provision. that it is an 10 U.S.C. 1107 does not Same as S. 15 as Reported by Same as S. 15 as Reported by IND, or a apply for the emergency use Committee. Committee. drug of products if the basis for an unapproved emergency declaration is the for its use, Defense Secretary's the reasons conclusion of a military for the emergency or potential for drug's use, one under Sec. 564 (b)(1)(B). and potential side effects. CRS-85 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Relation to Sec. 4 (a) "Sec. 564 (o)" Sec. 4 (a) "Sec. 564 (l)" Sec. 4 (a) "Sec. 564 (o)" Sec. 4 (a) "Sec. 564 (k)" These Other If a product is the subject of Same as S. 15 as Reported by Same as S. 15 as Reported by If a product is the subject of sections of Provisions an authorization under this Committee. Committee. an authorization under this U.S.C. relate section, the use of such section, the use of such to testing product within the scope of product within the scope of IND in the authorization -- the authorization -- humans. shall not be subject to any Same as S. 15 as Reported by Same as S. 15 as Reported by shall not be considered to requirements pursuant to Committee; Committee; constitute a clinical section 505(i) or 520(g); and investigation for purposes of section 505(i), section 520(g); shall not be subject to any Same as S. 15 as Reported by Same as S. 15 as Reported by or any other provision of this requirements otherwise Committee. Committee. act or section 351 of the applicable to clinical Public Health Service Act. investigations pursuant to other provisions of this act. CRS-86 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Discretion No similar provision. Sec. 4 (a) "Sec. 564 (m)" No similar provision. Sec. 4 (a) "Sec. 564 (l)" Regarding The HHS Secretary cannot Same as H.R. 2122. Use of require any person to carry Authoriza- out any activity this section tion makes lawful. People who choose not to carry out such activity are not required to inform the HHS Secretary of this choice, unless they are the sole source of an unapproved product that has been authorized for emergency use. In this case the manufacturer must notify the HHS Secretary of the choice not to participate in the program, within a reasonable time from the emergency-use authorization. CRS-87 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Enforce- Sec. 4 (a) "Sec. 564 (j)" Sec. 4 (a) "Sec. 564 (n)" Sec. 4 (a) "Sec. 564 (j)" No similar provision. ment A person who violates a A person who carries out an Same as S. 15 as Reported by requirement of this section or activity pursuant to an Committee. of a regulation or order authorization under this promulgated pursuant to this section, but who fails to section shall be subject to a comply with applicable civil money penalty of not conditions under subsection more than $100,000 in the (e), is in violation of the case of an individual, and not Federal Food, Drug, and more than $250,000 in the Cosmetic Act. case of any other person, for each violation, not to exceed $1,000,000 for all such violations adjudicated in a single proceeding. CRS-88 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Enforce- Sec. 4 (b) No similar provision. Sec. 4 (b) No similar provision. ment Technical amendments to Same as S. 15 as Reported by (continued) Section 301 of the Food, Committee. Drug and Cosmetic Act (21 U.S.C. 331) to allow enforcement of the new Sec. 564. Makes it a crime to: Same as S. 15 as Reported by Committee. (1) Promote or use a product that is the subject of an authorization under section 564 other than as stated in the authorization, or other than during the period described by section 564(g), unless such promotion or use is permitted under another provision of this act; (2) Fail to comply with an Same as S. 15 as Reported by information requirement Committee. under section 564(e). CRS-89 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Repeal of No similar provision. No similar provision. No similar provision. Sec. 4 (b) Subsection Termination Subsection (d) of section (d) specified Provision 1603 of the National Defense that Authorization Act for Fiscal enactment of Year 2004 (10 U.S.C. 1107a Project note) is repealed. BioShield would terminate the described "Application to Members of the Armed Forces" in the National Defense Authoriza- tion Act Section 1603 (similar to S. 15 as Reported Sec. 4 (a) "Sec. 564 (n)(1)" see above). Therefore with this repeal, those provisions remain in effect. CRS-90 Table 5. Required Reports Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House No similar provision. Sec. 5 Reports Regarding No similar provision. Sec. 5 Reports Regarding Authorities Under this act. Authorities Under this act. Notices and No similar provision. Sec. 5 (a)(1)(A) No similar provision. Sec. 5 (a)(1)(A) Annual The HHS Secretary will Same as H.R. 2122. Reports submit annual reports regarding the exercise of the following authorities (under Sections 2, 3 and 4 of this act): No similar provision. use of simplified acquisition No similar provision. Same as H.R. 2122, authority, No similar provision. use of other than full and No similar provision. Same as H.R. 2122, open competition, No similar provision. use of expedited peer review, No similar provision. Same as H.R. 2122, No similar provision. use of premium provision in No similar provision. Same as H.R. 2122, multiple-award contracts, CRS-91 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Notices and Sec. 4 (a) "Sec. 564 (h)" authorization of the Sec. 4 (a) "Sec. 564 (h)" Same as H.R. 2122, The S. 15 as Annual The HHS Secretary will emergency use of drugs, Same as S. 15 as Reported by Reported by Reports promptly publish in the Committee. Committee (continued) Federal Register, and provide and S. 1504 to the appropriate require case- congressional committees, a by-case notice of each authorization, notification authorization termination and rather than authorization revocation. annual reports with respect to these actions. Sec. 4 "Sec. 564 (b)(3)" declaration of any Sec. 4 "Sec. 564 (b)(3)" Same as H.R. 2122, The HHS Secretary must emergency, and Same as S. 15 as Reported by publish in the Federal Committee. Register and notify the appropriate congressional committees each declaration, determination and renewal. No similar provision. conditions placed on No similar provision. Same as H.R. 2122. emergency use of drugs emergency. CRS-92 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Contents of No similar provision. Sec. 5 (a)(1)(B) No similar provision. Sec. 5 (a)(1)(B) Reports These reports will be Same as H.R. 2122. submitted to the designated congressional committees and summarize -- No similar provision. the particular actions that No similar provision. Same as H.R. 2122; were taken under the authorities specified in subparagraph (A), including, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used; No similar provision. the reasons underlying the No similar provision. Same as H.R. 2122; decision to use such authorities, including any options that were considered and rejected with respect to the use of such authorities; CRS-93 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Contents of No similar provision. the identification of each No similar provision. the number of, nature of, and Reports person or entity that other information concerning (continued) received, or was considered the persons and entities that and rejected for, grants, received a grant, cooperative cooperative agreements, or agreement, or contract contracts pursuant to the use pursuant to the use of such of such authorities; and authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity; and No similar provision. whether, with respect to each No similar provision. Same as H.R. 2122. procurement that is approved by the President, a contract was entered into within one year after such presidential approval. CRS-94 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Annual No similar provision. Sec. 5 (a)(2) No similar provision. Sec. 5 (a)(2) Summaries The HHS Secretary shall Same as H.R. 2122. Regarding annually submit a report to Certain the designated congressional Activity committees that summarizes the activity relating to the exercise of the following authorities granted by Sec. 2 of this act: No similar provision. use of increased No similar provision. Same as H.R. 2122. micropurchase threshold, No similar provision. use of authority for personal No similar provision. Same as H.R. 2122. services contracts (including the number of persons who were paid amounts greater than $100,000 and the number of persons who were paid amounts between $50,000 and $100,000), and No similar provision. use of streamlined personnel No similar provision. Same as H.R. 2122. authority. CRS-95 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House National No similar provision. Sec. 5 (b)(1) No similar provision. No similar provision. Academy of Not later than four years after Sciences the date of the enactment of Review this act, the HHS Secretary will request the National Academy of Sciences to review the biomedical countermeasure research and development authorities established in this act to determine whether and to what extent activities undertaken pursuant to such authorities have enhanced the development of biomedical countermeasures affecting national security, and to recommend any legislative or administrative changes necessary to improve the ability of the Secretary to carry out these activities in the future. The Secretary shall ensure that the results of the study are submitted to the designated congressional committees not later than five years after enactment. CRS-96 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House National No similar provision. Sec. 5 (b)(2) No similar provision. No similar provision. Academy of This report shall include -- Sciences Review No similar provision. a summary of the most recent No similar provision. No similar provision. Report analysis by the Department Contents of Homeland Security and the intelligence community of the domestic threat from chemical, biological, radiological, and nuclear agents; No similar provision. the Academy's assessment of No similar provision. No similar provision. the current availability of countermeasures to address such threats; No similar provision. the Academy's assessment of No similar provision. No similar provision. the extent to which programs and activities under this act will reduce any gap between the threat and the availability of countermeasures to an acceptable level of risk; and CRS-97 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House National No similar provision. the Academy's assessment of No similar provision. No similar provision. Academy of threats to national security Sciences that are posed by technology Review that will enable, during the Report 10-year period beginning on Contents the date of the enactment of (continued) this act, the development of antibiotic- resistant, mutated, or bioengineered strains of biological agents; and No similar provision. recommendations on short- No similar provision. No similar provision. term and long-term governmental strategies for addressing such threats, including recommendations for federal policies regarding research priorities, the development of countermeasures, and investments in technology. CRS-98 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House General Sec. 6 Sec. 5 (c) Sec. 6 Sec. 5 (b) Accounting Not later than four years four years after the date of Same as S. 15 as Reported by Same as H.R. 2122. Office after the date of the the enactment of this act, the Committee. Review enactment of this act, the Comptroller General of the Comptroller General of the United States shall initiate a United States shall initiate a study -- study that -- (1)(A) to review the HHS Same as S. 15 as Reported by (A)(i) Same as H.R. 2122. The (1) describes the activities Secretary's use of the Committee. provisions conducted under the authorities granted under cited in S. 15 authorities provided for in this Act with respect to as Reported section 409J(b)(1) of the simplified acquisition by Public Health Service Act (as procedures, procedures other Committee added by section 2) and than full and open and S. 1504 section 319A-1(f)(3) and (4) competition, increased refer to of such Act (as added by micropurchase thresholds, simplified section 3); personal services contracts, acquisition streamlined personnel procedures authority, and the purchase and use of of security countermeasures non- under the special reserve competitive fund; and procedures. (1)(B) to recommend any No similar provision. (A)(ii) to make No similar provision. legislative or administrative recommendations to improve changes necessary to the utilization or improve the use or effectiveness of such effectiveness of such authorities in the future; authorities in the future; CRS-99 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House General (2) identifies any No similar provision. Same as S. 15 as Reported by No similar provision. Accounting procurements that would Committee; Office have been prohibited except Review for the authorities provided (continued) by this act; and. (3) to assess the adequacy of (2)(A) to review the internal Same as S. 15 as Reported by (B)(i) to review and assess internal controls instituted by controls instituted by the Committee. the adequacy of the internal the HHS Secretary with HHS Secretary with respect controls instituted by such respect to such authorities, to such authorities, where Secretary with respect to where required by this act. required by this act; and such authorities, where required by this act; and No similar provision. (2)(B) to recommend any No similar provision. (B)(ii) to make legislative or administrative recommendations to improve changes necessary to the effectiveness of such improve the effectiveness of controls; such controls; and CRS-100 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House General No similar provision. (3)(A) to review the No similar provision. (C)(i) Same as H.R. 2122; Accounting Secretary's use of the Office authority granted under this Review act to authorize an (continued) emergency use of a biomedical countermeasure, including the means by which the Secretary determines whether and under what conditions any such authorizations should be granted and the benefits and adverse impacts, if any, resulting from the use of such authority; and No similar provision. (3)(B) to recommend any No similar provision. (C)(ii) to make legislative or administrative recommendations to improve changes necessary to the utilization or improve the utilization or effectiveness of such effectiveness of such authority and to enhance authority and to enhance protection of the public protection of the public health; health. No similar provision. The results of the study shall No similar provision. Same as H.R. 2122. be submitted to the designated congressional committees not later than five years after the enactment of this act. CRS-101 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Report No similar provision. Sec. 5 (d)(1) No similar provision. Sec. 5 (c) Regarding Not later than 120 days after Same as H.R. 2122. Security enactment of this act, the Counter- DHS and HHS Secretaries measures will jointly report to the Procure- designated congressional ment committees whether there is Barriers a lack of adequate large-scale biocontainment facilities necessary for the testing of security countermeasures in accordance with Food and Drug Administration requirements. No similar provision. Sec. 5 (d)(2) No similar provision. No similar provision. Not later than one year after enactment of this act, the DHS and HHS Secretaries shall jointly report to the designated congressional committees any other potential barriers to the procurement of security countermeasures that have not been addressed by this act. CRS-102 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Report No similar provision. Sec. 5 (e) No similar provision. No similar provision. Regarding Not later than 270 days after Status of enactment of this act, the Program for DHS Secretary will submit to Chemical the designated congressional Terrorism committees a report Prepared- describing the status of the ness program carried out by the Secretary to enhance the preparedness of the United States to respond to terrorist attacks involving chemical agents. CRS-103 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Designated No similar provision. Sec. 5 (f) No similar provision. Sec. 5 (d) S. 15 as Congress- The term "designated Same as H.R. 2122. Reported by ional congressional committees" Committee Committees means the following and S. 1504 committees of Congress: use the phrase No similar provision. the House Committees on No similar provision. Same as H.R. 2122. "appropriate Energy and Commerce, congress- Appropriations, Government ional Reform, and the Select committees," Committee on Homeland elsewhere in Security (or any successor to the bills, the Select Committee); without specifying No similar provision. the Senate Committees on No similar provision. In the Senate: the which Health, Education, Labor, appropriate committees committees and Pensions; they are. Appropriations; and Government Affairs. CRS-104 Table 6. Outreach Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Outreach No similar provision. Sec. 6 No similar provision. Sec. 6 The HHS Secretary will The HHS Secretary will develop outreach measures to develop outreach measures to ensure to the extent ensure to the extent practicable that diverse practicable that diverse institutions, including institutions, including Historically Black Colleges Historically Black Colleges and Universities and those and Universities and those serving large proportions of serving large proportions of Hispanics, Native Americans, Black or African Americans, Asian-Pacific Americans, or American Indians, other underrepresented Appalachian Americans, populations, are Alaska Natives, Asians, meaningfully aware of Native Hawaiians, other available research and Pacific Islanders, Hispanics development grants, or Latinos, or other contracts, cooperative underrepresented agreements, and populations, are procurements conducted meaningfully aware of under sections 2 and 3 of this available research and act. development grants, contracts, cooperative agreements, and procurements conducted under sections 2 and 3 of this act. CRS-105 Table 7. Export Control Recommendation Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Recom- No similar provision. Sec. 7 No similar provision. Sec. 7 mendation Upon the award of any grant, Same as H.R. 2122. for Export contract, or cooperative Controls on agreement under section 2 or Certain 3 of this act for the research, Biomedical development, or procurement Counter- of a countermeasure the HHS measures Secretary will, in consultation with the heads of other appropriate federal agencies, determine whether such countermeasure is subject to existing export- related controls and, if not, may make a recommendation that such countermeasure should be included on the list of controlled items subject to export-related controls. CRS-106 Table 8. Interagency Coordination Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Ensuring No similar provision. Sec. 8 (a) No similar provision. Sec. 8 (a) Coordina- The HHS, DHS and Defense Same as H.R. 2122. tion, Secretaries will ensure that Cooperation the activities of their and the respective Departments Elimination coordinate, complement, and of do not unnecessarily Unnecessary duplicate programs to Duplication identify potential domestic in Programs threats from biological, chemical, radiological or nuclear agents, detect domestic incidents involving such agents, analyze such incidents, and develop necessary countermeasures. The Secretaries will ensure that information and technology possessed by their Departments relevant to these activities are shared with the other Departments. CRS-107 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Designation No similar provision. Sec. 8 (b) No similar provision. Sec. 8 (b) of Agency The HHS, DHS and Defense Same as H.R. 2122. Coordin- Secretaries will each ation designate an officer or Officer employee of their respective Departments who shall coordinate, through regular meetings and communications, with the other aforementioned Departments such programs and activities carried out by their Departments. CRS-108 Table 9. Smallpox- Related Amendments to the Homeland Security Act and Public Health Services Act Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Smallpox- Sec. 5 No similar provision. No similar provision. No similar provision. The Related These provisions concern Smallpox Amend- smallpox countermeasures Emergency ments to the and were considered by Personnel Homeland other legislation. Protection Security Act Act of 2003 and Public (P.L.108-20) Health incorporated Services Act many of the provisions in S. 15 as Reported. CRS-109 Table 10. Additional HHS Secretary Authorities During National Emergencies Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Authority of No similar provision. No similar provision. Sec. 5 Sec. 9 the HHS Amends section 1135(b) of Same as S. 1504. Secretary the Social Security Act that During was added by the Public National Health Security and Emer- Bioterrorism Preparedness gencies and Response Act of 2002 (P.L. 107-188). No similar provision. No similar provision. Allows the HHS Secretary in Same as S. 1504. emergencies to waive or modify -- No similar provision. No similar provision. sanctions relating to the Same as S. 1504. examination and treatment of emergency medical conditions and women in labor, if individuals are directed to or relocated to receive medical screening in an alternative location pursuant to an appropriate State emergency preparedness plan, No similar provision. No similar provision. sanctions and penalties that Same as S. 1504. arise from noncompliance with the following requirements: CRS-110 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Authority of No similar provision. No similar provision. to obtain a patient's Same as S. 1504. the HHS agreement to speak with Secretary family members or friends; During and National Emer- No similar provision. No similar provision. to honor a request to opt out Same as S. 1504. gencies of the facility directory; (continued) No similar provision. No similar provision. requirement to distribute a Same as S. 1504. notice; or No similar provision. No similar provision. relating to the patient's right Same as S. 1504. to request privacy restrictions; and confidential communications. CRS-111 Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Authority of No similar provision. No similar provision. Such waivers or Such waivers or the HHS modifications shall be modifications shall only be in Secretary limited to a 72-hour period effect if such actions are During beginning upon taken in a manner that does National implementation of a hospital not discriminate among Emer- disaster protocol. A waiver or individuals on the basis of gencies modification shall be their source of payment or of (continued) withdrawn after such period their ability to pay, and shall and the provider shall be limited to a 72-hour comply with the period beginning upon requirements under such implementation of a hospital paragraph for any patient still disaster protocol. A waiver or under the care of the modification shall be provider. withdrawn after such period and the provider shall comply with the requirements under such paragraph for any patient still under the care of the provider. CRS-112 Table 11. Special Funding Language Provision S. 15 as Reported by H.R. 2122 as Passed by S. 1504 as Introduced S. 15 as Enacted Comments Committee House Special No similar provision. No similar provision. Sec. 7 No similar provision. Funding In the Senate, for purposes of Language points of order under a for Project concurrent resolution on the BioShield budget and the Congressional Budget Act of 1974, provisions contained in any bill, resolution, amendment, motion, or conference report that change the availability of any amounts appropriated pursuant to this act (or an amendment made by this act) shall not be scored with respect to the level of budget authority or outlays contained in such bill, resolution, amendment, motion, or conference report. ------------------------------------------------------------------------------ For other versions of this document, see http://wikileaks.org/wiki/CRS-RL32549