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107th Congress Report | HOUSE OFREPRESENTATIVES I 2dSession I , i^.^gl PUBLIC HEALTH SECURITY AND BIOTER- RORISM PREPAREDNESS AND RESPONSE ACT OF 2002 CONFERENCE REPORT TO ACCOMPANY H.R. 3448 May 21, 2002.—Ordered to be printed U.S. GOVERNMENT PRINTING OFFICE WASHINGTON 2002 : 107th Congress1 HOUSE OF REPRESENTATIVES f Report 2d Session io7-481 PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 May21, 2002.—Orderedtobeprinted Mr. Tauzin, from the Committee ofconference, submitted the following CONFERENCE REPORT [To accompanyH.R. 3448] The committee of conference on the disagreeing votes of the two Houses on the amendment of the Senate to the bill (H.R. 3448), to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies, having met, after full and free conference, have agreed to recommend and do recommend to their respective Houses as follows: That the House recede from its disagreement to the amendment of the Senate and agree to the same with an amendment as follows: In lieu of the matter proposed to be inserted by the Senate amendment, insert the following: SECTION1. SHORTTITLE; TABLE OFCONTENTS. (a) Short Title.—This Act may be cited as the "Public Health Security and Bioterrorism Pre—paredness and Response Act of2002". (b) Table of Contents. The table ofcontents ofthe Act is as follows: TITLEI—NATIONALPREPAREDNESSFORBIOTERRORISMAND OTHER PUBLICHEALTHEMERGENCIES — SubtitleA NationalPreparedness andResponsePlanning, Coordinating, and Reporting Sec. 101. Nationalpreparedness and response. Sec. 102. Assistant Secretary for Public Health Emergency Preparedness; National DisasterMedical System. Sec. 103. ImprovingabilityofCentersforDisease ControlandPrevention. Sec. 104. Advisory committees and communications; study regarding communications abilitiesofpublic health agencies. Sec. 105. Education ofhealth carepersonnel;trainingregardingpediatric issues. Sec. 106. Grants regardingshortagesofcertain healthprofessionals. 99-006 Sec. 107. Emergency system for advance registration of health professions volunteers. Sec. 108. Workinggroup. Sec. 109. Antimicrobial resistance. Sec. 110. Supplies andservices in lieu ofawardfunds. Sec. 111. Additionalamendments. — SubtitleB StrategicNationalStockpile;DevelopmentofPriority Countermeasures Sec. 121. Strategic nationalstockpile. Sec. 122. Acceleratedapproval ofpriority countermeasures. Sec. 123. Issuance ofrule on animal trials. Sec. 124. Securityforcountermeasure developmentandproduction. Sec. 125. Acceleratedcountermeasure research anddevelopment. Sec. 126. Evaluation ofnew and emerging technologies regarding bioterrorist attack andotherpublichealth emergencies. Sec. 127. Potassium iodide. — Subtitle C ImprovingState, Local, andHospitalPreparednessforandResponse to Bioterrorism and OtherPublicHealthEmergencies Sec. 131. Grants to improve State, local, and hospitalpreparednessforand response to bioterrorism andotherpublichealth emergencies. — SubtitleD EmergencyAuthorities;AdditionalProvisions fSec. 141. Reportingdeadlines. Sec. 142. Streamlining and clarifying communicable disease quarantineprovisions. Sec. 143. Emergency waiverofMedicare, Medicaid, andSCHIPrequirements. Sec. 144. Provisionforexpiration ofpublichealth emergencies. — SubtitleE AdditionalProvisions Sec. 151. DesignatedStatepublicemergencyannouncementplan. Sec. 152. Expandedresearch by SecretaryofEnergy. Sec. 153. Expandedresearch on workerhealth andsafety. Sec. 154. Enhancement of emergency preparedness ofDepartment of Veterans Af- fairs. Sec. 155. Reauthorization ofexistingprogram. Sec. 156. Sense ofCongress. Sec. 157. GeneralAccounting Office report. Sec. 158. Certain awards. Sec. 159. Public access defibrillationprograms andpublic access defibrillation dem- onstrationprojects. TITLEII—ENHANCING CONTROLS ONDANGEROUSBIOLOGICALAGENTS AND TOXINS — SubtitleA DepartmentofHealth andHuman Services Sec. 201. Regulationofcertain biologicalagents and toxins. Sec. 202. Implementation byDepartmentofHealth andHuman Services. Sec. 203. Effective dates. Sec. 204. Conformingamendment. — SubtitleB DepartmentofAgriculture Sec. 211. Shorttitle. Sec. 212. Regulation ofcertain biological agents andtoxins. Sec. 213. Implementation byDepartmentofAgriculture. — Subtitle C Interagency CoordinationRegarding OverlapAgents and Toxins Sec. 221. Interagencycoordination. — SubtitleD CriminalPenaltiesRegarding CertainBiologicalAgents and Toxins Sec. 231. Criminalpenalties. TITLEIII—PROTECTINGSAFETYAND SECURITYOFFOODANDDRUG SUPPLY — SubtitleA Protection ofFoodSupply Sec. 301. Foodsafety andsecuritystrategy. Sec. 302. Protection againstadulteration offood. 3 Sec. 303. Administrative detention. Sec. 304. Debarmentforrepeatedorseriousfood import violations. Sec. 305. Registration offoodfacilities. Sec. 306. Maintenance and inspection ofrecordsforfoods. Sec. 307. Priornotice ofimportedfoodshipments. Sec. 308. Authority to mark articles refusedadmission into UnitedStates. Sec. 309. Prohibition againstportshopping. Sec. 310. Notices toStates regardingimportedfood. Sec. 311. Grants toStatesforinspections. Sec. 312. Surveillanceand informationgrantsandauthorities. Sec. 313. Surveillanceofzoonoticdiseases. Sec. 314. Authority tocommission otherFederalofficials to conductinspections. Sec. 315. Rule ofconstruction. — SubtitleB Protection ofDrugSupply Sec. 321. Annual registration offoreign manufacturers; shipping information; drug anddevice listing. Sec. 322. Requirement ofadditional information regarding import components in- tendedfor use inexportproducts. — Subtitle C GeneralProvisionsRelatingto Upgrade ofAgricultural Security Sec. 331. Expansion ofAnimalandPlantHealthInspection Service activities. Sec. 332. Expansion ofFoodSafetyInspection Serviceactivities. Sec. 333. Biosecurity upgradesat theDepartmentofAgriculture. Sec. 334. Agricultural biosecurity. Sec. 335. Agricultural bioterrorism research anddevelopment. Sec. 336. Animalenterprise terrorismpenalties. TITLEIV—DRINKING WATERSECURITYAND SAFETY Sec. 401. Terroristandotherintentional acts. Sec. 402. OtherSafeDrinking WaterActamendments. Sec. 403. Miscellaneous and technicalamendments. TITLE V—ADDITIONALPROVISIONS — SubtitleA PrescriptionDrug UserFees Sec. 501. Short title. Sec. 502. Findings. Sec. 503. Definitions. Sec. 504. Authority toassessand use drugfees. Sec. 505. Accountabilityand reports. Sec. 506. Reports ofpostmarketingstudies. Sec. 507. Savings clause. Sec. 508. Effective date. Sec. 509. Sunsetclause. — SubtitleB FundingProvisionsRegardingFoodandDrugAdministration Sec. 521. Office ofDrugSafety. Sec. 522. Division ofDrugMarketing,Advertising, and Communications. Sec. 523. OfficeofGenericDrugs. — Subtitle C AdditionalProvisions Sec. 531. Transition to digital television. Sec. 532. 3-year delay in lock in procedures for Medicare+Choice plans; change in Medicare+Choice reporting deadlines and annual, coordinated election periodfor2003, 2004, and2005. 4 TITLE I—NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUB- LIC HEALTH EMERGENCIES — Subtitle A National Preparedness and Re- sponse Planning^ Coordinating^ and Re- porting SEC. 101. NATIONALPREPAREDNESSANDRESPONSE. (a) In General.—The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by adding at the end the following title: ''TITLE XXVIII—NATIONAL PREPARED- NESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMER- GENCIES — ''Subtitle A National Preparedness and Response Planning^ Coordinating, and Reporting "SEC. 2801. NATIONAL—PREPAREDNESSPLAN. "(a) In General. "(1) Preparedness— and response regarding public HEALTH EMERGENCIES. The Secretary shall further develop and implement a coordinated strategy, building upon the core public health capabilities established pursuant to section 319A, for carrying out health-related activities to prepare for and respond effectively to bioterrorism and other public health emergencies, including the preparation ofa plan under this section. The Secretary shall periodically thereafter review and, as appropriate, revise theplan. — "(2) National approach. In carrying out paragraph (1), the Secretary shall collaborate with the States toward the goal ofensuring that the activities ofthe Secretary regarding bioterrorism and other public health emergencies are coordinated with activities ofthe States, including—localgovernments. "(3) Evaluation of progress. The plan under paragraph (1) shall provide for specific benchmarks and outcome measures for evaluating the progress of the Secretary and the States, including local governments, with respect to the plan under paragraph including progress toward achieving the (1), goals specified in subsection —(b). "(b) Preparedness Goals. The plan under subsection (a) should includeprovisions in furtherance ofthe following: "(1) Providing effective assistance to State and local governments in the event of bioterrorism or other public health emergency. 5 "(2) Ensuring that State and local governments have appropriate capacity to detect and respond effectively to such emergencies, including capacities for the following: ''(A) Effective public health surveillance and reporting mechanisms at the State and local levels. ''(B) Appropriate laboratory readiness. "(C) Properly trained and equipped emergency response, public health, and medicalpersonnel. ''(D) Health and safety protection of workers responding to such an emergency. "(E) Public health agencies that are prepared to coordinate health services (including mental health services) during and after such emergencies. "(F) Participation in communications networks that can effectively disseminate relevant information in a timely and secure manner to appropriate public and private entities and to thepublic. "(3) Developing and maintaining medical countermeasures (such as drugs, vaccines and other biological products, medical devices, and other supplies) against biological agents and toxins that may be involved in such emergencies. "(4) Ensuring coordination and minimizing duplication of Federal, State, and local planning, preparedness, and response activities, including during the investigation of a suspicious disease outbreak or otherpotentialpublic health emergency. "(5) Enhancing the readiness ofhospitals and other health care facilities to respond effectively to such emergencies. "(c) Reports to Cong—ress.— "(1) In general. Not later than one year after the date of the enactment of the Public Health Security and Bioterrorism Preparedness and Response Act of2002, and biennially thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House ofRepresentatives, and the Com- mittee on Health, Education, Labor, and Pensions of the Sen- ate, a report concerningprogress with respect to the plan under subsection (a), including progress toward achieving the goals specified in subsection (b). — "(2) Additional authority. Reports submitted under paragraph (1) by the Secretary (oth—er than the first report) shall make recommendations concerning "(A) any additional legislative authority that the Sec- retary determines is necessary for fully implementing the plan under subsection (a), including meeting the goals under subsection (b); and "(B) any additional legislative authority that the Sec- retary determines is necessary under section 319 to protect the public health in the event ofan emergency described in section 319(a). — "(d) Rule of Construction. This section may not be con- strued as expanding or limiting any of the authorities of the Sec- retary that, on the day before the date ofthe enactment ofthe Public Health Security and Bioterrorism Preparedness and Response Act of 2002, were in effect with respect to preparing for and responding effectively to bioterrorism a—nd otherpublic health emergencies.". (b) Other Reports. 6 — (1) In general. Not later than one year after the date of the enactment of this Act, the Secretary ofHealth and Human Services (referred to in this subsection as the ''Secretary") shall submit to the Committee on Energy and Commerce ofthe House of Representatives, and the Committee on Health, Ed—ucation, Labor, and Pensions ofthe Senate, a report concerning (A) the recommendations and findings of the National Advisory Committee on Children and Terrorism under section 319F(c)(2) ofthe Public Health Service Act; (B) the recommendations and findings ofthe EPICAd- visory Committee under section 319F(c)(3) ofsuch Act; (C) the characteristics that may render a rural community uniquely vulnerable to a biological attack, including distance, lack of emergency transport, hospital or laboratory capacity, lack ofintegration ofFederal or State public health networks, workforce deficits, or other relevant characteristics; (D) the characteristics that may render areas or populations designated as medically underserved populations (as defined in section 330 ofsuch Act) uniquely vulnerable to a biological attack, including significant numbers oflow- income or uninsured individuals, lack ofaffordable and ac- cessible health care services, insufficient public and pri- mary health care resources, lack of integration of Federal or State public health networks, workforce deficits, or other relevant characteristics; (E) the recommendations of the Secretary with respect to additional legislative authority that the Secretary determines is necessary to effectively strengthen rural commu- nities, or medically underserved populations (as defined in section 330 ofsuch Act); and (F) the need for and benefits ofa National Disaster Re- sponse Medical Volunteer Service that would be a private- sector, community-based rapid response corps of medical volunteers. (—2) Study regarding local emergency response methods. The Secretary shall conduct a study ofeffective methods for the provision of emergency response services through local governments (including through private response contractors and volunteers ofsuch governments) in a consistent manner in response to acts of bioterrorism or other public health emergencies. Not later than 180 days after the date ofthe enactment ofthis Act, the Secretary shall submit to the Committee on En- ergy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report describing the findings ofthe study. SEC. 102. ASSISTANT SECRETARY FOR PUBLIC HEALTH EMERGENCY PREPAREDNESS;NATIONALDISASTERMEDICALSYSTEM. (a) In General.—Title XXVHI ofthe Public Health Service Act, as added by section 101 of this Act, is amended by adding at the end the following subtitle: 7 — ^^Subtitle B Emergency Preparedness and Response ''SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM AND OTHER PUBLIC HEALTH EMER- GENCIES. ''(a) Assist—ant Secretary for Public Health Emergency PREPAREDNESS. — ''(1) In GENERAL. There is established within the Depart- ment of Health and Human Services the position ofAssistant Secretary for Public Health Emergency Preparedness. The President shall appoint an individual to serve in such position. Such Assistant Se—cretary shall report to the Secretary. ''(2) Duties. Subject to the authority of the Secretary, the Assistant Secretary for Public Health Emergency Preparedness shall carry out the following duties with respect to bioterrorism and otherpublic health emergencies: — ''(A) Coordinate on behalfofthe Secretary "(i) interagency interfaces between the Department of Health and Human Services (referred to in this paragraph as the 'Department') and other departments, agencies, and offices ofthe United States; and "(ii) interfaces between the Department and State and local entities with responsibility for emergencypre- paredness. "(B) Coordinate the operations ofthe National Disaster Medical System and any other emergency response activities within the Department ofHealth and Human Services that are related to bioterrorism and other public health emergencies. TC) Coordinate the efforts ofthe Department to bolster State and local emergency preparedness for a bioterrorist attack or other public health emergency, and evaluate the progress of such entities in meeting the benchmarks and other outcome measures contained in the nationalplan and in meeting the core public health capabilities established pursuant to 319A. "(D) Any other duties determined appropriate by the Secretary. — "(b) National Disast—er Medical System. "(1) In general. The Secretary shall provide for the operation in accordance with this section of a system to be known as the National Disaster Medical System. The Secretary shall designate the Assistant Secretary for Public Health Emergency Preparedness as the head ofthe National Disaster Medical Sys- tem, subject to the authority ofthe Secretary. — "(2) Federaland state coLLABORATrvE system. "(A) In general.—The National Disaster Medical Sys- tem shall be a coordinated effort by the Federal agencies specified in subparagraph (B), working in collaboration with the States and other appropriate public orprivate entities, to carry out the purposes described in p—aragraph (3). "(B) Participating federal agencies. The Federal agencies referred to in subparagraph (A) are the Depart- 8 ment of Health and Human Services, the Federal Emer- gency Management Agency, the Department ofDefense, and the Department ofVeteran—s Affairs. "(3) Purpose of syst—em. TAj In general. The Secret—ary may activate the Na- tional Disaster Medical System to 'W provide health services, health-related social services, other appropriate human services, and appropriate auxiliary services to respond to the needs of vic- tims of a public health emergency (whether or not determined to be a public health emergency under section 319); or "(ii) bepresent at locations, andfor limitedperiods oftime, specified by the Secretary on the basis that the Secretary has determined that a location is at risk of apublic health emergency du—ring the time specified. "(B) Ongoing activities. The National Disaster Medical System shall carry out such ongoing activities as may be necessary toprepare for the provision ofservices described in subparagraph (A) in the event that the Secretary activates the National Disaster Medical System for such purposes. — ''(C) Test for mobilization of system. During the one-year period beginning on the date of the enactment of the Public Health Security and Bioterrorism Preparedness and Response Act of2002, the Secretary shall conduct an exercise to test the capability and timeliness ofthe National Disaster Medical System to mobilize and otherwise respond effectively to a bioterrorist attack or other public health emergency that affects two or more geographic locations concurrently. Thereafter, the Secretary may periodically conduct such exercises regarding the National Disaster Medical System as the Secretary determines to be appropriate. — Tcj Criteria. — "(1) In general. The Secretary shall establish criteria for the operation ofthe National Disaster Medical System. "—(2) Participation agreements for non-federal entities. In carrying outparagraph (1), the Secretary shall establish criteria regarding the participation of States and private entities in the National Disaster Medical System, including criteria regarding agreements for such participation. The criteria shall include the following: TAJ Provisions relating to the custody and use ofFed- eral personal property by such entities, which may in the discretion of the Secretary include authorizing the custody and use ofsuch property to respond to emergency situations for which the National Disaster Medical System has not been activated by the Secretary pursuant to subsection (b)(3)(A). Any such custody and use of Federal personal property shall be on a reimbursable basis. "(B) Provisions relating to circumstances in which an individual or entity has agreements with both the National Disaster Medical System and another entity regarding the provision ofemergency services by the individual. Suchpro-