" ! HOUSE OF REPRESENTATIVES 107TH CONGRESS

2d Session

REPORT

107–481

PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE

ACT OF 2002

CONFERENCE REPORT

TO ACCOMPANY

H.R. 3448

MAY 21, 2002.—Ordered to be printed

PUBLIC HEALTH SECURITY AND BIOTERRORISM

PREPAREDNESS AND RESPONSE ACT OF 2002

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

1

99–006

" ! HOUSE OF REPRESENTATIVES 107TH CONGRESS

2d Session

REPORT

107–481

2002

PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE

ACT OF 2002

CONFERENCE REPORT

TO ACCOMPANY

H.R. 3448

MAY 21, 2002.—Ordered to be printed

99–006

107TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 2d Session 107–481

PUBLIC HEALTH SECURITY AND BIOTERRORISM

PREPAREDNESS AND RESPONSE ACT OF 2002

MAY 21, 2002.—Ordered to be printed

Mr. TAUZIN, from the Committee of conference,

submitted the following

CONFERENCE REPORT

[To accompany H.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:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE.—This Act may be cited as the ‘‘Public Health

Security and Bioterrorism Preparedness and Response Act of 2002’’.

(b) TABLE OF CONTENTS.—The table of contents of the Act is as

follows:

TITLE I—NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER

PUBLIC HEALTH EMERGENCIES

Subtitle A—National Preparedness and Response Planning, Coordinating, and

Reporting

Sec. 101. National preparedness and response.

Sec. 102. Assistant Secretary for Public Health Emergency Preparedness; National

Disaster Medical System.

Sec. 103. Improving ability of Centers for Disease Control and Prevention.

Sec. 104. Advisory committees and communications; study regarding communications abilities of public health agencies.

Sec. 105. Education of health care personnel; training regarding pediatric issues.

Sec. 106. Grants regarding shortages of certain health professionals.

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Sec. 107. Emergency system for advance registration of health professions volunteers.

Sec. 108. Working group.

Sec. 109. Antimicrobial resistance.

Sec. 110. Supplies and services in lieu of award funds.

Sec. 111. Additional amendments.

Subtitle B—Strategic National Stockpile; Development of Priority Countermeasures

Sec. 121. Strategic national stockpile.

Sec. 122. Accelerated approval of priority countermeasures.

Sec. 123. Issuance of rule on animal trials.

Sec. 124. Security for countermeasure development and production.

Sec. 125. Accelerated countermeasure research and development.

Sec. 126. Evaluation of new and emerging technologies regarding bioterrorist attack

and other public health emergencies.

Sec. 127. Potassium iodide.

Subtitle C—Improving State, Local, and Hospital Preparedness for and Response to

Bioterrorism and Other Public Health Emergencies

Sec. 131. Grants to improve State, local, and hospital preparedness for and response

to bioterrorism and other public health emergencies.

Subtitle D—Emergency Authorities; Additional Provisions

Sec. 141. Reporting deadlines.

Sec. 142. Streamlining and clarifying communicable disease quarantine provisions.

Sec. 143. Emergency waiver of Medicare, Medicaid, and SCHIP requirements.

Sec. 144. Provision for expiration of public health emergencies.

Subtitle E—Additional Provisions

Sec. 151. Designated State public emergency announcement plan.

Sec. 152. Expanded research by Secretary of Energy.

Sec. 153. Expanded research on worker health and safety.

Sec. 154. Enhancement of emergency preparedness of Department of Veterans Affairs.

Sec. 155. Reauthorization of existing program.

Sec. 156. Sense of Congress.

Sec. 157. General Accounting Office report.

Sec. 158. Certain awards.

Sec. 159. Public access defibrillation programs and public access defibrillation demonstration projects.

TITLE II—ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS

AND TOXINS

Subtitle A—Department of Health and Human Services

Sec. 201. Regulation of certain biological agents and toxins.

Sec. 202. Implementation by Department of Health and Human Services.

Sec. 203. Effective dates.

Sec. 204. Conforming amendment.

Subtitle B—Department of Agriculture

Sec. 211. Short title.

Sec. 212. Regulation of certain biological agents and toxins.

Sec. 213. Implementation by Department of Agriculture.

Subtitle C—Interagency Coordination Regarding Overlap Agents and Toxins

Sec. 221. Interagency coordination.

Subtitle D—Criminal Penalties Regarding Certain Biological Agents and Toxins

Sec. 231. Criminal penalties.

TITLE III—PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG

SUPPLY

Subtitle A—Protection of Food Supply

Sec. 301. Food safety and security strategy.

Sec. 302. Protection against adulteration of food.

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Sec. 303. Administrative detention.

Sec. 304. Debarment for repeated or serious food import violations.

Sec. 305. Registration of food facilities.

Sec. 306. Maintenance and inspection of records for foods.

Sec. 307. Prior notice of imported food shipments.

Sec. 308. Authority to mark articles refused admission into United States.

Sec. 309. Prohibition against port shopping.

Sec. 310. Notices to States regarding imported food.

Sec. 311. Grants to States for inspections.

Sec. 312. Surveillance and information grants and authorities.

Sec. 313. Surveillance of zoonotic diseases.

Sec. 314. Authority to commission other Federal officials to conduct inspections.

Sec. 315. Rule of construction.

Subtitle B—Protection of Drug Supply

Sec. 321. Annual registration of foreign manufacturers; shipping information; drug

and device listing.

Sec. 322. Requirement of additional information regarding import components intended for use in export products.

Subtitle C—General Provisions Relating to Upgrade of Agricultural Security

Sec. 331. Expansion of Animal and Plant Health Inspection Service activities.

Sec. 332. Expansion of Food Safety Inspection Service activities.

Sec. 333. Biosecurity upgrades at the Department of Agriculture.

Sec. 334. Agricultural biosecurity.

Sec. 335. Agricultural bioterrorism research and development.

Sec. 336. Animal enterprise terrorism penalties.

TITLE IV—DRINKING WATER SECURITY AND SAFETY

Sec. 401. Terrorist and other intentional acts.

Sec. 402. Other Safe Drinking Water Act amendments.

Sec. 403. Miscellaneous and technical amendments.

TITLE V—ADDITIONAL PROVISIONS

Subtitle A—Prescription Drug User Fees

Sec. 501. Short title.

Sec. 502. Findings.

Sec. 503. Definitions.

Sec. 504. Authority to assess and use drug fees.

Sec. 505. Accountability and reports.

Sec. 506. Reports of postmarketing studies.

Sec. 507. Savings clause.

Sec. 508. Effective date.

Sec. 509. Sunset clause.

Subtitle B—Funding Provisions Regarding Food and Drug Administration

Sec. 521. Office of Drug Safety.

Sec. 522. Division of Drug Marketing, Advertising, and Communications.

Sec. 523. Office of Generic Drugs.

Subtitle C—Additional Provisions

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

period for 2003, 2004, and 2005.

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TITLE I—NATIONAL PREPAREDNESS

FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES

Subtitle A—National Preparedness and Response Planning, Coordinating, and Reporting

SEC. 101. NATIONAL PREPAREDNESS AND RESPONSE.

(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 PREPAREDNESS FOR BIOTERRORISM AND

OTHER PUBLIC HEALTH EMERGENCIES

‘‘Subtitle A—National Preparedness and

Response Planning, Coordinating, and

Reporting

‘‘SEC. 2801. NATIONAL PREPAREDNESS PLAN.

‘‘(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 of a plan under this section.

The Secretary shall periodically thereafter review and, as appropriate, revise the plan.

‘‘(2) NATIONAL APPROACH.—In carrying out paragraph (1),

the Secretary shall collaborate with the States toward the goal

of ensuring that the activities of the Secretary regarding bioterrorism and other public health emergencies are coordinated

with activities of the States, including local governments.

‘‘(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 (1), including progress toward achieving the

goals specified in subsection (b).

‘‘(b) PREPAREDNESS GOALS.—The plan under subsection (a)

should include provisions in furtherance of the following:

‘‘(1) Providing effective assistance to State and local governments in the event of bioterrorism or other public health emergency.

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‘‘(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 medical personnel. ‘‘(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 the public.

‘‘(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 other potential public health emergency. ‘‘(5) Enhancing the readiness of hospitals and other health

care facilities to respond effectively to such emergencies.

‘‘(c) REPORTS TO CONGRESS.— ‘‘(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 of 2002, and biennially thereafter, the Secretary shall submit to the Committee on Energy

and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report concerning progress 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 (other than the first report) shall

make recommendations concerning— ‘‘(A) any additional legislative authority that the Secretary 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 Secretary determines is necessary under section 319 to protect

the public health in the event of an emergency described in

section 319(a). ‘‘(d) RULE OF CONSTRUCTION.—This section may not be construed as expanding or limiting any of the authorities of the Secretary that, on the day before the date of the enactment of the Public

Health Security and Bioterrorism Preparedness and Response Act of

2002, were in effect with respect to preparing for and responding effectively to bioterrorism and other public health emergencies.’’. (b) OTHER REPORTS.—

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(1) IN GENERAL.—Not later than one year after the date of

the enactment of this Act, the Secretary of Health and Human

Services (referred to in this subsection as the ‘‘Secretary’’) shall

submit to the Committee on Energy and Commerce of the House

of Representatives, and the Committee on Health, Education,

Labor, and Pensions of the Senate, a report concerning—

(A) the recommendations and findings of the National

Advisory Committee on Children and Terrorism under section 319F(c)(2) of the Public Health Service Act;

(B) the recommendations and findings of the EPIC Advisory Committee under section 319F(c)(3) of such 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 of integration of Federal 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 of such Act) uniquely vulnerable

to a biological attack, including significant numbers of lowincome or uninsured individuals, lack of affordable and accessible health care services, insufficient public and primary 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 communities, or medically underserved populations (as defined in

section 330 of such Act); and

(F) the need for and benefits of a National Disaster Response Medical Volunteer Service that would be a privatesector, community-based rapid response corps of medical

volunteers.

(2) STUDY REGARDING LOCAL EMERGENCY RESPONSE METHODS.—The Secretary shall conduct a study of effective methods

for the provision of emergency response services through local

governments (including through private response contractors

and volunteers of such governments) in a consistent manner in

response to acts of bioterrorism or other public health emergencies. Not later than 180 days after the date of the enactment

of this Act, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and the

Committee on Health, Education, Labor, and Pensions of the

Senate, a report describing the findings of the study.

SEC. 102. ASSISTANT SECRETARY FOR PUBLIC HEALTH EMERGENCY

PREPAREDNESS; NATIONAL DISASTER MEDICAL SYSTEM.

(a) IN GENERAL.—Title XXVIII of the Public Health Service Act,

as added by section 101 of this Act, is amended by adding at the

end the following subtitle:

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‘‘Subtitle B—Emergency Preparedness and

Response

‘‘SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE

TO BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES.

‘‘(a) ASSISTANT SECRETARY FOR PUBLIC HEALTH EMERGENCY

PREPAREDNESS.—

‘‘(1) IN GENERAL.—There is established within the Department of Health and Human Services the position of Assistant

Secretary for Public Health Emergency Preparedness. The

President shall appoint an individual to serve in such position.

Such Assistant Secretary 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 other public health emergencies:

‘‘(A) Coordinate on behalf of the 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 of the United States; and

‘‘(ii) interfaces between the Department and State

and local entities with responsibility for emergency preparedness.

‘‘(B) Coordinate the operations of the National Disaster

Medical System and any other emergency response activities within the Department of Health and Human Services

that are related to bioterrorism and other public health

emergencies.

‘‘(C) Coordinate the efforts of the 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 national plan and

in meeting the core public health capabilities established

pursuant to 319A.

‘‘(D) Any other duties determined appropriate by the

Secretary.

‘‘(b) NATIONAL DISASTER 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 of the National Disaster Medical System, subject to the authority of the Secretary.

‘‘(2) FEDERAL AND STATE COLLABORATIVE SYSTEM.—

‘‘(A) IN GENERAL.—The National Disaster Medical System shall be a coordinated effort by the Federal agencies

specified in subparagraph (B), working in collaboration

with the States and other appropriate public or private entities, to carry out the purposes described in paragraph (3).

‘‘(B) PARTICIPATING FEDERAL AGENCIES.—The Federal

agencies referred to in subparagraph (A) are the DepartVerDate 11-MAY-2000 07:55 May 23, 2002 Jkt 099006 PO 00000 Frm 00011 Fmt 6659 Sfmt 6603 E:\HR\OC\HR481.XXX pfrm09 PsN: HR481
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ment of Health and Human Services, the Federal Emergency Management Agency, the Department of Defense, and

the Department of Veterans Affairs.

‘‘(3) PURPOSE OF SYSTEM.— ‘‘(A) IN GENERAL.—The Secretary may activate the National Disaster Medical System to— ‘‘(i) provide health services, health-related social

services, other appropriate human services, and appropriate auxiliary services to respond to the needs of victims of a public health emergency (whether or not determined to be a public health emergency under section

319); or ‘‘(ii) be present at locations, and for limited periods

of time, specified by the Secretary on the basis that the

Secretary has determined that a location is at risk of

a public health emergency during the time specified.

‘‘(B) ONGOING ACTIVITIES.—The National Disaster

Medical System shall carry out such ongoing activities as

may be necessary to prepare for the provision of services 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 of 2002, the Secretary shall conduct an

exercise to test the capability and timeliness of the 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.

‘‘(c) CRITERIA.— ‘‘(1) IN GENERAL.—The Secretary shall establish criteria for

the operation of the National Disaster Medical System. ‘‘(2) PARTICIPATION AGREEMENTS FOR NON-FEDERAL ENTI- TIES.—In carrying out paragraph (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: ‘‘(A) Provisions relating to the custody and use of Federal personal property by such entities, which may in the

discretion of the Secretary include authorizing the custody

and use of such 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 of emergency services by the individual. Such proVerDate 11-MAY-2000 07:55 May 23, 2002 Jkt 099006 PO 00000 Frm 00012 Fmt 6659 Sfmt 6603 E:\HR\OC\HR481.XXX pfrm09 PsN: HR481
9

visions shall address the issue of priorities among the

agreements involved. ‘‘(d) INTERMITTENT DISASTER-RESPONSE PERSONNEL.— ‘‘(1) IN GENERAL.—For the purpose of assisting the National

Disaster Medical System in carrying out duties under this section, the Secretary may appoint individuals to serve as intermittent personnel of such System in accordance with applicable

civil service laws and regulations. ‘‘(2) LIABILITY.—For purposes of section 224(a) and the remedies described in such section, an individual appointed under

paragraph (1) shall, while acting within the scope of such appointment, be considered to be an employee of the Public Health

Service performing medical, surgical, dental, or related functions. With respect to the participation of individuals appointed

under paragraph (1) in training programs authorized by the

Assistant Secretary for Public Health Emergency Preparedness

or a comparable official of any Federal agency specified in subsection (b)(2)(B), acts of individuals so appointed that are within the scope of such participation shall be considered within the

scope of the appointment under paragraph (1) (regardless of

whether the individuals receive compensation for such participation).

‘‘(e) CERTAIN EMPLOYMENT ISSUES REGARDING INTERMITTENT

APPOINTMENTS.— ‘‘(1) INTERMITTENT DISASTER-RESPONSE APPOINTEE.—For

purposes of this subsection, the term ‘intermittent disaster-response appointee’ means an individual appointed by the Secretary under subsection (d). ‘‘(2) COMPENSATION FOR WORK INJURIES.—An intermittent

disaster-response appointee shall, while acting in the scope of

such appointment, be considered to be an employee of the Public

Health Service performing medical, surgical, dental, or related

functions, and an injury sustained by such an individual shall

be deemed ‘in the performance of duty’, for purposes of chapter

81 of title 5, United States Code, pertaining to compensation for

work injuries. With respect to the participation of individuals

appointed under subsection (d) in training programs authorized

by the Assistant Secretary for Public Health Emergency Preparedness or a comparable official of any Federal agency specified in subsection (b)(2)(B), injuries sustained by such an individual, while acting within the scope of such participation, also

shall be deemed ‘in the performance of duty’ for purposes of

chapter 81 of title 5, United States Code (regardless of whether

the individuals receive compensation for such participation). In

the event of an injury to such an intermittent disaster-response

appointee, the Secretary of Labor shall be responsible for making determinations as to whether the claimant is entitled to

compensation or other benefits in accordance with chapter 81 of

title 5, United States Code.

‘‘(3) EMPLOYMENT AND REEMPLOYMENT RIGHTS.— ‘‘(A) IN GENERAL.—Service as an intermittent disasterresponse appointee when the Secretary activates the National Disaster Medical System or when the individual participates in a training program authorized by the Assistant

Secretary for Public Health Emergency Preparedness or a

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comparable official of any Federal agency specified in subsection (b)(2)(B) shall be deemed ‘service in the uniformed

services’ for purposes of chapter 43 of title 38, United States

Code, pertaining to employment and reemployment rights

of individuals who have performed service in the uniformed

services (regardless of whether the individual receives compensation for such participation). All rights and obligations

of such persons and procedures for assistance, enforcement,

and investigation shall be as provided for in chapter 43 of

title 38, United States Code. ‘‘(B) NOTICE OF ABSENCE FROM POSITION OF EMPLOY- MENT.—Preclusion of giving notice of service by necessity of

Service as an intermittent disaster-response appointee when

the Secretary activates the National Disaster Medical System shall be deemed preclusion by ‘military necessity’ for

purposes of section 4312(b) of title 38, United States Code,

pertaining to giving notice of absence from a position of employment. A determination of such necessity shall be made

by the Secretary, in consultation with the Secretary of Defense, and shall not be subject to judicial review.

‘‘(4) LIMITATION.—An intermittent disaster-response appointee shall not be deemed an employee of the Department of

Health and Human Services for purposes other than those specifically set forth in this section.

‘‘(f) RULE OF CONSTRUCTION REGARDING USE OF COMMISSIONED CORPS.—If the Secretary assigns commissioned officers of

the Regular or Reserve Corps to serve with the National Disaster

Medical System, such assignments do not affect the terms and conditions of their appointments as commissioned officers of the Regular or Reserve Corps, respectively (including with respect to pay

and allowances, retirement, benefits, rights, privileges, and immunities).

‘‘(g) DEFINITION.—For purposes of this section, the term ‘auxiliary services’ includes mortuary services, veterinary services, and

other services that are determined by the Secretary to be appropriate

with respect to the needs referred to in subsection (b)(3)(A). ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

providing for the Assistant Secretary for Public Health Emergency

Preparedness and the operations of the National Disaster Medical

System, other than purposes for which amounts in the Public

Health Emergency Fund under section 319 are available, there are

authorized to be appropriated such sums as may be necessary for

each of the fiscal years 2002 through 2006.’’. (b) SENSE OF CONGRESS REGARDING RESOURCES OF NATIONAL

DISASTER MEDICAL SYSTEM.—It is the sense of the Congress that

the Secretary of Health and Human Services should provide sufficient resources to entities tasked to carry out the duties of the National Disaster Medical System for reimbursement of expenses, operations, purchase and maintenance of equipment, training, and other

funds expended in furtherance of the National Disaster Medical

System.

SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE CONTROL

AND PREVENTION.

Section 319D of the Public Health Service Act (42 U.S.C. 247d–

4) is amended to read as follows:

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‘‘SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND

PREVENTION.

‘‘(a) FACILITIES; CAPACITIES.—

‘‘(1) FINDINGS.—Congress finds that the Centers for Disease

Control and Prevention has an essential role in defending

against and combatting public health threats and requires secure and modern facilities, and expanded and improved capabilities related to bioterrorism and other public health emergencies, sufficient to enable such Centers to conduct this important mission.

‘‘(2) FACILITIES.—

‘‘(A) IN GENERAL.—The Director of the Centers for Disease Control and Prevention may design, construct, and

equip new facilities, renovate existing facilities (including

laboratories, laboratory support buildings, scientific communication facilities, transshipment complexes, secured

and isolated parking structures, office buildings, and other

facilities and infrastructure), and upgrade security of such

facilities, in order to better conduct the capacities described

in section 319A, and for supporting public health activities.

‘‘(B) MULTIYEAR CONTRACTING AUTHORITY.—For any

project of designing, constructing, equipping, or renovating

any facility under subparagraph (A), the Director of the

Centers for Disease Control and Prevention may enter into

a single contract or related contracts that collectively include the full scope of the project, and the solicitation and

contract shall contain the clause ‘availability of funds’

found at section 52.232–18 of title 48, Code of Federal Regulations.

‘‘(3) IMPROVING THE CAPACITIES OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION.—The Secretary, taking into

account evaluations under section 319B(a), shall expand, enhance, and improve the capabilities of the Centers for Disease

Control and Prevention relating to preparedness for and responding effectively to bioterrorism and other public health

emergencies. Activities that may be carried out under the preceding sentence include—

‘‘(A) expanding or enhancing the training of personnel;

‘‘(B) improving communications facilities and networks, including delivery of necessary information to rural

areas;

‘‘(C) improving capabilities for public health surveillance and reporting activities, taking into account the integrated system or systems of public health alert communications and surveillance networks under subsection (b); and

‘‘(D) improving laboratory facilities related to bioterrorism and other public health emergencies, including increasing the security of such facilities.

‘‘(b) NATIONAL COMMUNICATIONS AND SURVEILLANCE NETWORKS.—

‘‘(1) IN GENERAL.—The Secretary, directly or through

awards of grants, contracts, or cooperative agreements, shall

provide for the establishment of an integrated system or systems

of public health alert communications and surveillance networks between and among—

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‘‘(A) Federal, State, and local public health officials;

‘‘(B) public and private health-related laboratories, hospitals, and other health care facilities; and

‘‘(C) any other entities determined appropriate by the

Secretary.

‘‘(2) REQUIREMENTS.—The Secretary shall ensure that networks under paragraph (1) allow for the timely sharing and

discussion, in a secure manner, of essential information concerning bioterrorism or another public health emergency, or recommended methods for responding to such an attack or emergency.

‘‘(3) STANDARDS.—Not later than one year after the date of

the enactment of the Public Health Security and Bioterrorism

Preparedness and Response Act of 2002, the Secretary, in cooperation with health care providers and State and local public

health officials, shall establish any additional technical and reporting standards (including standards for interoperability) for

networks under paragraph (1).

‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—

‘‘(1) FACILITIES; CAPACITIES.—

‘‘(A) FACILITIES.—For the purpose of carrying out subsection (a)(2), there are authorized to be appropriated

$300,000,000 for each of the fiscal years 2002 and 2003,

and such sums as may be necessary for each of the fiscal

years 2004 through 2006.

‘‘(B) MISSION; IMPROVING CAPACITIES.—For the purposes of achieving the mission of the Centers for Disease

Control and Prevention described in subsection (a)(1), for

carrying out subsection (a)(3), for better conducting the capacities described in section 319A, and for supporting public health activities, there are authorized to be appropriated

such sums as may be necessary for each of the fiscal years

2002 through 2006.

‘‘(2) NATIONAL COMMUNICATIONS AND SURVEILLANCE NETWORKS.—For the purpose of carrying out subsection (b), there

are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006.’’.

SEC. 104. ADVISORY COMMITTEES AND COMMUNICATIONS; STUDY REGARDING COMMUNICATIONS ABILITIES OF PUBLIC

HEALTH AGENCIES.

(a) IN GENERAL.—Section 319F of the Public Health Service Act

(42 U.S.C. 247d–6) is amended—

(1) by striking subsections (b) and (i);

(2) by redesignating subsections (c) through (h) as subsections (e) through (j), respectively; and

(3) by inserting after subsection (a) the following subsections:

‘‘(b) ADVICE TO THE FEDERAL GOVERNMENT.—

‘‘(1) REQUIRED ADVISORY COMMITTEES.—In coordination

with the working group under subsection (a), the Secretary

shall establish advisory committees in accordance with paragraphs (2) and (3) to provide expert recommendations to assist

such working groups in carrying out their respective responsibilities under subsections (a) and (b).

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‘‘(2) NATIONAL ADVISORY COMMITTEE ON CHILDREN AND

TERRORISM.— ‘‘(A) IN GENERAL.—For purposes of paragraph (1), the

Secretary shall establish an advisory committee to be

known as the National Advisory Committee on Children

and Terrorism (referred to in this paragraph as the ‘Advisory Committee’). ‘‘(B) DUTIES.—The Advisory Committee shall provide

recommendations regarding— ‘‘(i) the preparedness of the health care (including

mental health care) system to respond to bioterrorism

as it relates to children; ‘‘(ii) needed changes to the health care and emergency medical service systems and emergency medical

services protocols to meet the special needs of children;

and ‘‘(iii) changes, if necessary, to the national stockpile

under section 121 of the Public Health Security and

Bioterrorism Preparedness and Response Act of 2002 to

meet the emergency health security of children.

‘‘(C) COMPOSITION.—The Advisory Committee shall be

composed of such Federal officials as may be appropriate

to address the special needs of the diverse population

groups of children, and child health experts on infectious

disease, environmental health, toxicology, and other relevant professional disciplines. ‘‘(D) TERMINATION.—The Advisory Committee terminates one year after the date of the enactment of the Public

Health Security and Bioterrorism Preparedness and Response Act of 2002.

‘‘(3) EMERGENCY PUBLIC INFORMATION AND COMMUNICATIONS ADVISORY COMMITTEE.—

‘‘(A) IN GENERAL.—For purposes of paragraph (1), the

Secretary shall establish an advisory committee to be

known as the Emergency Public Information and Communications Advisory Committee (referred to in this paragraph as the ‘EPIC Advisory Committee’).

‘‘(B) DUTIES.—The EPIC Advisory Committee shall

make recommendations to the Secretary and the working

group under subsection (a) and report on appropriate ways

to communicate public health information regarding bioterrorism and other public health emergencies to the public. ‘‘(C) COMPOSITION.—The EPIC Advisory Committee

shall be composed of individuals representing a diverse

group of experts in public health, medicine, communications, behavioral psychology, and other areas determined

appropriate by the Secretary.

‘‘(D) DISSEMINATION.—The Secretary shall review the

recommendations of the EPIC Advisory Committee and ensure that appropriate information is disseminated to the

public.

‘‘(E) TERMINATION.—The EPIC Advisory Committee

terminates one year after the date of the enactment of Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

14

‘‘(c) STRATEGY FOR COMMUNICATION OF INFORMATION REGARD- ING BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES.—In

coordination with working group under subsection (a), the Secretary

shall develop a strategy for effectively communicating information

regarding bioterrorism and other public health emergencies, and

shall develop means by which to communicate such information.

The Secretary may carry out the preceding sentence directly or

through grants, contracts, or cooperative agreements. ‘‘(d) RECOMMENDATION OF CONGRESS REGARDING OFFICIAL

FEDERAL INTERNET SITE ON BIOTERRORISM.—It is the recommendation of Congress that there should be established an official Federal

Internet site on bioterrorism, either directly or through provision of

a grant to an entity that has expertise in bioterrorism and the development of websites, that should include information relevant to diverse populations (including messages directed at the general public

and such relevant groups as medical personnel, public safety workers, and agricultural workers) and links to appropriate State and

local government sites.’’. (b) STUDY REGARDING COMMUNICATIONS ABILITIES OF PUBLIC

HEALTH AGENCIES.—The Secretary of Health and Human Services,

in consultation with the Federal Communications Commission, the

National Telecommunications and Information Administration, and

other appropriate Federal agencies, shall conduct a study to determine whether local public health entities have the ability to maintain communications in the event of a bioterrorist attack or other

public health emergency. The study shall examine whether

redundancies are required in the telecommunications system, particularly with respect to mobile communications, for public health

entities to maintain systems operability and connectivity during

such emergencies. The study shall also include recommendations to

industry and public health entities about how to implement such

redundancies if necessary.

SEC. 105. EDUCATION OF HEALTH CARE PERSONNEL; TRAINING REGARDING PEDIATRIC ISSUES.

Section 319F(g) of the Public Health Service Act, as redesignated by section 104(a)(2) of this Act, is amended to read as follows:

‘‘(g) EDUCATION; TRAINING REGARDING PEDIATRIC ISSUES.—

‘‘(1) MATERIALS; CORE CURRICULUM.—The Secretary, in collaboration with members of the working group described in

subsection (b), and professional organizations and societies,

shall—

‘‘(A) develop materials for teaching the elements of a

core curriculum for the recognition and identification of potential bioweapons and other agents that may create a public health emergency, and for the care of victims of such

emergencies, recognizing the special needs of children and

other vulnerable populations, to public health officials,

medical professionals, emergency physicians and other

emergency department staff, laboratory personnel, and

other personnel working in health care facilities (including

poison control centers);

‘‘(B) develop a core curriculum and materials for community-wide planning by State and local governments, hospitals and other health care facilities, emergency response

units, and appropriate public and private sector entities to

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respond to a bioterrorist attack or other public health emergency;

‘‘(C) develop materials for proficiency testing of laboratory and other public health personnel for the recognition

and identification of potential bioweapons and other agents

that may create a public health emergency; and

‘‘(D) provide for dissemination and teaching of the materials described in subparagraphs (A) through (C) by appropriate means, which may include telemedicine, long-distance learning, or other such means.

‘‘(2) CERTAIN ENTITIES.—The entities through which education and training activities described in paragraph (1) may

be carried out include Public Health Preparedness Centers, the

Public Health Service’s Noble Training Center, the Emerging

Infections Program, the Epidemic Intelligence Service, the Public Health Leadership Institute, multi-State, multi-institutional

consortia, other appropriate educational entities, professional

organizations and societies, private accrediting organizations,

and other nonprofit institutions or entities meeting criteria established by the Secretary.

‘‘(3) GRANTS AND CONTRACTS.—In carrying out paragraph

(1), the Secretary may carry out activities directly and through

the award of grants and contracts, and may enter into interagency cooperative agreements with other Federal agencies.

‘‘(4) HEALTH-RELATED ASSISTANCE FOR EMERGENCY RESPONSE PERSONNEL TRAINING.—The Secretary, in consultation

with the Attorney General and the Director of the Federal

Emergency Management Agency, may provide technical assistance with respect to health-related aspects of emergency response personnel training carried out by the Department of Justice and the Federal Emergency Management Agency.’’.

SEC. 106. GRANTS REGARDING SHORTAGES OF CERTAIN HEALTH PROFESSIONALS.

Part B of title III of the Public Health Service Act (42 U.S.C.

243 et seq.) is amended by inserting after section 319G the following

section:

‘‘SEC. 319H. GRANTS REGARDING TRAINING AND EDUCATION OF CERTAIN HEALTH PROFESSIONALS.

‘‘(a) IN GENERAL.—The Secretary may make awards of grants

and cooperative agreements to appropriate public and nonprofit private health or educational entities, including health professions

schools and programs as defined in section 799B, for the purpose

of providing low-interest loans, partial scholarships, partial fellowships, revolving loan funds, or other cost-sharing forms of assistance for the education and training of individuals in any category

of health professions for which there is a shortage that the Secretary

determines should be alleviated in order to prepare for or respond

effectively to bioterrorism and other public health emergencies.

‘‘(b) AUTHORITY REGARDING NON-FEDERAL CONTRIBUTIONS.—

The Secretary may require as a condition of an award under subsection (a) that a grantee under such subsection provide non-Federal

contributions toward the purpose described in such subsection.

‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, there are authorized to be appropriated

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such sums as may be necessary for each of the fiscal years 2002

through 2006.’’.

SEC. 107. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF

HEALTH PROFESSIONS VOLUNTEERS.

Part B of title III of the Public Health Service Act, as amended

by section 106 of this Act, is amended by inserting after section

319H the following section:

‘‘SEC. 319I. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF

HEALTH PROFESSIONS VOLUNTEERS.

‘‘(a) IN GENERAL.—The Secretary shall, directly or through an

award of a grant, contract, or cooperative agreement, establish and

maintain a system for the advance registration of health professionals for the purpose of verifying the credentials, licenses, accreditations, and hospital privileges of such professionals when, during

public health emergencies, the professionals volunteer to provide

health services (referred to in this section as the ‘verification system’). In carrying out the preceding sentence, the Secretary shall

provide for an electronic database for the verification system.

‘‘(b) CERTAIN CRITERIA.—The Secretary shall establish provisions regarding the promptness and efficiency of the system in collecting, storing, updating, and disseminating information on the

credentials, licenses, accreditations, and hospital privileges of volunteers described in subsection (a).

‘‘(c) OTHER ASSISTANCE.—The Secretary may make grants and

provide technical assistance to States and other public or nonprofit

private entities for activities relating to the verification system developed under subsection (a).

‘‘(d) COORDINATION AMONG STATES.—The Secretary may encourage each State to provide legal authority during a public health

emergency for health professionals authorized in another State to

provide certain health services to provide such health services in the

State.

‘‘(e) RULE OF CONSTRUCTION.—This section may not be construed as authorizing the Secretary to issue requirements regarding

the provision by the States of credentials, licenses, accreditations, or

hospital privileges.

‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, there are authorized to be appropriated

$2,000,000 for fiscal year 2002, and such sums as may be necessary

for each of the fiscal years 2003 through 2006.’’.

SEC. 108. WORKING GROUP.

Section 319F of the Public Health Service Act, as amended by

section 104(a), is amended by striking subsection (a) and inserting

the following:

‘‘(a) WORKING GROUP ON BIOTERRORISM AND OTHER PUBLIC

HEALTH EMERGENCIES.—

‘‘(1) IN GENERAL.—The Secretary, in coordination with the

Secretary of Agriculture, the Attorney General, the Director of

Central Intelligence, the Secretary of Defense, the Secretary of

Energy, the Administrator of the Environmental Protection

Agency, the Director of the Federal Emergency Management

Agency, the Secretary of Labor, the Secretary of Veterans Affairs, and with other similar Federal officials as determined appropriate, shall establish a working group on the prevention,

17

preparedness, and response to bioterrorism and other public

health emergencies. Such joint working group, or subcommittees

thereof, shall meet periodically for the purpose of consultation

on, assisting in, and making recommendations on— ‘‘(A) responding to a bioterrorist attack, including the

provision of appropriate safety and health training and

protective measures for medical, emergency service, and

other personnel responding to such attacks; ‘‘(B) prioritizing countermeasures required to treat, prevent, or identify exposure to a biological agent or toxin pursuant to section 351A; ‘‘(C) facilitation of the awarding of grants, contracts, or

cooperative agreements for the development, manufacture,

distribution, supply-chain management, and purchase of

priority countermeasures; ‘‘(D) research on pathogens likely to be used in a biological threat or attack on the civilian population; ‘‘(E) development of shared standards for equipment to

detect and to protect against biological agents and toxins; ‘‘(F) assessment of the priorities for and enhancement

of the preparedness of public health institutions, providers

of medical care, and other emergency service personnel (including firefighters) to detect, diagnose, and respond (including mental health response) to a biological threat or attack;‘‘(G) in the recognition that medical and public health

professionals are likely to provide much of the first response

to such an attack, development and enhancement of the

quality of joint planning and training programs that address the public health and medical consequences of a biological threat or attack on the civilian population

between—

‘‘(i) local firefighters, ambulance personnel, police

and public security officers, or other emergency response personnel; and

‘‘(ii) hospitals, primary care facilities, and public

health agencies;

‘‘(H) development of strategies for Federal, State, and

local agencies to communicate information to the public regarding biological threats or attacks;

‘‘(I) ensuring that the activities under this subsection

address the health security needs of children and other vulnerable populations;

‘‘(J) strategies for decontaminating facilities contaminated as a result of a biological attack, including appropriate protections for the safety of workers conducting such

activities;

‘‘(K) subject to compliance with other provisions of Federal law, clarifying the responsibilities among Federal officials for the investigation of suspicious outbreaks of disease

and other potential public health emergencies, and for related revisions of the interagency plan known as the Federal response plan; and

‘‘(L) in consultation with the National Highway Traffic

Safety Administration and the U.S. Fire Administration,

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ways to enhance coordination among Federal agencies involved with State, local, and community based emergency

medical services, including issuing a report that—

‘‘(i) identifies needs of community-based emergency

medical services; and

‘‘(ii) identifies ways to streamline and enhance the

process through which Federal agencies support community-based emergency medical services.

‘‘(2) CONSULTATION WITH EXPERTS.—In carrying out subparagraphs (B) and (C) of paragraph (1), the working group

under such paragraph shall consult with the pharmaceutical,

biotechnology, and medical device industries, and other appropriate experts.

‘‘(3) USE OF SUBCOMMITTEES REGARDING CONSULTATION REQUIREMENTS.—With respect to a requirement under law that

the working group under paragraph (1) be consulted on a matter, the working group may designate an appropriate subcommittee of the working group to engage in the consultation.

‘‘(4) DISCRETION IN EXERCISE OF DUTIES.—Determinations

made by the working group under paragraph (1) with respect

to carrying out duties under such paragraph are matters committed to agency discretion for purposes of section 701(a) of title

5, United States Code.

‘‘(5) RULE OF CONSTRUCTION.—This subsection may not be

construed as establishing new regulatory authority for any of

the officials specified in paragraph (1), or as having any legal

effect on any other provision of law, including the responsibilities and authorities of the Environmental Protection Agency.’’.

SEC. 109. ANTIMICROBIAL RESISTANCE.

Section 319E of the Public Health Service Act (42 U.S.C. 247d–

5) is amended—

(1) in subsection (b)—

(A) by striking ‘‘shall conduct and support’’ and inserting ‘‘shall directly or through awards of grants or cooperative agreements to public or private entities provide for the

conduct of’’; and

(B) by amending paragraph (4) to read as follows:

‘‘(4) the sequencing of the genomes, or other DNA analysis,

or other comparative analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in

consultation with the task force established under subsection

(a)), in collaboration and coordination with the activities of the

Department of Defense and the Joint Genome Institute of the

Department of Energy; and’’;

(2) in subsection (e)(2), by inserting after ‘‘societies,’’ the following: ‘‘schools or programs that train medical laboratory personnel,’’; and

(3) in subsection (g), by striking ‘‘and such sums’’ and all

that follows and inserting the following: ‘‘$25,000,000 for each

of the fiscal years 2002 and 2003, and such sums as may be

necessary for each of the fiscal years 2004 through 2006.’’.

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SEC. 110. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.

Part B of title III of the Public Health Service Act, as amended

by section 107 of this Act, is amended by inserting after section 319I

the following section:

‘‘SEC. 319J. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.

‘‘(a) IN GENERAL.—Upon the request of a recipient of an award

under any of sections 319 through 319I or section 319K, the Secretary may, subject to subsection (b), provide supplies, equipment,

and services for the purpose of aiding the recipient in carrying out

the purposes for which the award is made and, for such purposes,

may detail to the recipient any officer or employee of the Department

of Health and Human Services.

‘‘(b) CORRESPONDING REDUCTION IN PAYMENTS.—With respect

to a request described in subsection (a), the Secretary shall reduce

the amount of payments under the award involved by an amount

equal to the costs of detailing personnel and the fair market value

of any supplies, equipment, or services provided by the Secretary.

The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.’’.

SEC. 111. ADDITIONAL AMENDMENTS.

Part B of title III of the Public Health Service Act (42 U.S.C.

243 et seq) is amended—

(1) in section 319A(a)(1), by striking ‘‘10 years’’ and inserting ‘‘five years’’;

(2) in section 319B(a), in the first sentence, by striking ‘‘10

years’’ and inserting ‘‘five years’’; and

(3) in section 391F(e)(2), as redesignated by section

104(a)(2) of this Act—

(A) by striking ‘‘or’’ after ‘‘clinic,’’; and

(B) by inserting before the period following: ‘‘, professional organization or society, school or program that

trains medical laboratory personnel, private accrediting organization, or other nonprofit private institution or entity

meeting criteria established by the Secretary’’.

Subtitle B—Strategic National Stockpile;

Development of Priority Countermeasures

SEC. 121. STRATEGIC NATIONAL STOCKPILE.

(a) STRATEGIC NATIONAL STOCKPILE.—

(1) IN GENERAL.—The Secretary of Health and Human

Services (referred to in this section as the ‘‘Secretary’’), in coordination with the Secretary of Veterans Affairs, shall maintain a stockpile or stockpiles of drugs, vaccines and other biological products, medical devices, and other supplies in such

numbers, types, and amounts as are determined by the Secretary to be appropriate and practicable, taking into account

other available sources, to provide for the emergency health security of the United States, including the emergency health security of children and other vulnerable populations, in the event

of a bioterrorist attack or other public health emergency.

(2) PROCEDURES.—The Secretary, in managing the stockpile under paragraph (1), shall—

20

(A) consult with the working group under section

319F(a) of the Public Health Service Act;

(B) ensure that adequate procedures are followed with

respect to such stockpile for inventory management and accounting, and for the physical security of the stockpile;

(C) in consultation with Federal, State, and local officials, take into consideration the timing and location of

special events;

(D) review and revise, as appropriate, the contents of

the stockpile on a regular basis to ensure that emerging

threats, advanced technologies, and new countermeasures

are adequately considered;

(E) devise plans for the effective and timely supplychain management of the stockpile, in consultation with appropriate Federal, State and local agencies, and the public

and private health care infrastructure; and

(F) ensure the adequate physical security of the stockpile.

(b) SMALLPOX VACCINE DEVELOPMENT.— (1) IN GENERAL.—The Secretary shall award contracts,

enter into cooperative agreements, or carry out such other activities as may reasonably be required in order to ensure that

the stockpile under subsection (a) includes an amount of vaccine against smallpox as determined by the Secretary to be sufficient to meet the health security needs of the United States.

(2) RULE OF CONSTRUCTION.—Nothing in this section shall

be construed to limit the private distribution, purchase, or sale

of vaccines from sources other than the stockpile described in

subsection (a).

(c) DISCLOSURES.—No Federal agency shall disclose under section 552, United States Code, any information identifying the location at which materials in the stockpile under subsection (a) are

stored.

(d) DEFINITION.—For purposes of subsection (a), the term ‘‘stockpile’’ includes— (1) a physical accumulation (at one or more locations) of

the supplies described in subsection (a); or

(2) a contractual agreement between the Secretary and a

vendor or vendors under which such vendor or vendors agree to

provide to the Secretary supplies described in subsection (a).

(e) AUTHORIZATION OF APPROPRIATIONS.— (1) STRATEGIC NATIONAL STOCKPILE.—For the purpose of

carrying out subsection (a), there are authorized to be appropriated $640,000,000 for fiscal year 2002, and such sums as

may be necessary for each of fiscal years 2003 through 2006.

(2) SMALLPOX VACCINE DEVELOPMENT.—For the purpose of

carrying out subsection (b), there are authorized to be appropriated $509,000,000 for fiscal year 2002, and such sums as

may be necessary for each of fiscal years 2003 through 2006.

SEC. 122. ACCELERATED APPROVAL OF PRIORITY COUNTERMEASURES.

(a) IN GENERAL.—The Secretary of Health and Human Services

may designate a priority countermeasure as a fast-track product

pursuant to section 506 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 356) or as a device granted review priority pursuant

21

to section 515(d)(5) of such Act (21 U.S.C. 360e(d)(5)). Such a designation may be made prior to the submission of—

(1) a request for designation by the sponsor or applicant; or

(2) an application for the investigation of the drug under

section 505(i) of such Act or section 351(a)(3) of the Public

Health Service Act.

Nothing in this subsection shall be construed to prohibit a sponsor

or applicant from declining such a designation.

(b) USE OF ANIMAL TRIALS.—A drug for which approval is

sought under section 505(b) of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act on the

basis of evidence of effectiveness that is derived from animal studies

pursuant to section 123 may be designated as a fast track product

for purposes of this section.

(c) PRIORITY REVIEW OF DRUGS AND BIOLOGICAL PRODUCTS.—

A priority countermeasure that is a drug or biological product shall

be considered a priority drug or biological product for purposes of

performance goals for priority drugs or biological products agreed

to by the Commissioner of Food and Drugs.

(d) DEFINITIONS.—For purposes of this title:

(1) The term ‘‘priority countermeasure’’ has the meaning

given such term in section 319F(h)(4) of the Public Health Service Act.

(2) The term ‘‘priority drugs or biological products’’ means

a drug or biological product that is the subject of a drug or biologics application referred to in section 101(4) of the Food and

Drug Administration Modernization Act of 1997.

SEC. 123. ISSUANCE OF RULE ON ANIMAL TRIALS.

Not later than 90 days after the date of the enactment of this

Act, the Secretary of Health and Human Services shall complete the

process of rulemaking that was commenced under authority of section 505 of the Federal Food, Drug, and Cosmetic Act and section

351 of the Public Health Service Act with the issuance of the proposed rule entitled ‘‘New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use

Against Lethal or Permanently Disabling Toxic Substances When

Efficacy Studies in Humans Ethically Cannot be Conducted’’ published in the Federal Register on October 5, 1999 (64 Fed. Reg.

53960), and shall promulgate a final rule.

SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND PRODUCTION.

Part B of title III of the Public Health Service Act, as amended

by section 110 of this Act, is amended by inserting after section

319J the following section:

‘‘SEC. 319K. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND

PRODUCTION.

‘‘(a) IN GENERAL.—The Secretary, in consultation with the Attorney General and the Secretary of Defense, may provide technical

or other assistance to provide security to persons or facilities that

conduct development, production, distribution, or storage of priority

countermeasures (as defined in section 319F(h)(4)).

‘‘(b) GUIDELINES.—The Secretary may develop guidelines to enable entities eligible to receive assistance under subsection (a) to secure their facilities against potential terrorist attack.’’.

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SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH AND DEVELOPMENT.

Section 319F(h) of the Public Health Service Act, as redesignated by section 104(a)(2) of this Act, is amended to read as follows:

‘‘(h) ACCELERATED RESEARCH AND DEVELOPMENT ON PRIORITY

PATHOGENS AND COUNTERMEASURES.—

‘‘(1) IN GENERAL.—With respect to pathogens of potential

use in a bioterrorist attack, and other agents that may cause a

public health emergency, the Secretary, taking into consideration any recommendations of the working group under subsection (a), shall conduct, and award grants, contracts, or cooperative agreements for, research, investigations, experiments,

demonstrations, and studies in the health sciences relating to—

‘‘(A) the epidemiology and pathogenesis of such pathogens;

‘‘(B) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens

(as determined by the Director of the National Institutes of

Health in consultation with the working group established

in subsection (a)), in collaboration and coordination with

the activities of the Department of Defense and the Joint

Genome Institute of the Department of Energy;

‘‘(C) the development of priority countermeasures; and

‘‘(D) other relevant areas of research;

with consideration given to the needs of children and other vulnerable populations.

‘‘(2) PRIORITY.—The Secretary shall give priority under this

section to the funding of research and other studies related to

priority countermeasures.

‘‘(3) ROLE OF DEPARTMENT OF VETERANS AFFAIRS.—In carrying out paragraph (1), the Secretary shall consider using the

biomedical research and development capabilities of the Department of Veterans Affairs, in conjunction with that Department’s

affiliations with health-professions universities. When advantageous to the Government in furtherance of the purposes of

such paragraph, the Secretary may enter into cooperative agreements with the Secretary of Veterans Affairs to achieve such

purposes.

‘‘(4) PRIORITY COUNTERMEASURES.—For purposes of this

section, the term ‘priority countermeasure’ means a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or

diagnostic test that the Secretary determines to be—

‘‘(A) a priority to treat, identify, or prevent infection by

a biological agent or toxin listed pursuant to section

351A(a)(1), or harm from any other agent that may cause

a public health emergency; or

‘‘(B) a priority to diagnose conditions that may result

in adverse health consequences or death and may be caused

by the administering of a drug, biological product, device,

vaccine, vaccine adjuvant, antiviral, or diagnostic test that

is a priority under subparagraph (A).’’.

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SEC. 126. EVALUATION OF NEW AND EMERGING TECHNOLOGIES REGARDING BIOTERRORIST ATTACK AND OTHER PUBLIC

HEALTH EMERGENCIES.

(a) IN GENERAL.—The Secretary of Health and Human Services

(referred to in this section as the ‘‘Secretary’’) shall promptly carry

out a program to periodically evaluate new and emerging technologies that, in the determination of the Secretary, are designed to

improve or enhance the ability of public health or safety officials to

conduct public health surveillance activities relating to a bioterrorist attack or other public health emergency.

(b) CERTAIN ACTIVITIES.—In carrying out this subsection, the

Secretary shall, to the extent practicable—

(1) survey existing technology programs funded by the Federal Government for potentially useful technologies;

(2) promptly issue a request, as necessary, for information

from non-Federal public and private entities for ongoing activities in this area; and

(3) evaluate technologies identified under paragraphs (1)

and (2) pursuant to subsection (c).

(c) CONSULTATION AND EVALUATION.—In carrying out subsection (b)(3), the Secretary shall consult with the working group

under section 319F(a) of the Public Health Service Act, as well as

other appropriate public, nonprofit, and private entities, to develop

criteria for the evaluation of such technologies and to conduct such

evaluations.

(d) REPORT.—Not later than 180 days after the date of the enactment of this Act, and periodically thereafter, the Secretary shall

submit to the Committee on Energy and Commerce of the House of

Representatives, and the Committee on Health, Education, Labor,

and Pensions of the Senate, a report on the activities under this section.

SEC. 127. POTASSIUM IODIDE.

(a) IN GENERAL.—Through the national stockpile under section

121, the President, subject to subsections (b) and (c), shall make

available to State and local governments potassium iodide tablets

for stockpiling and for distribution as appropriate to public facilities, such as schools and hospitals, in quantities sufficient to provide adequate protection for the population within 20 miles of a nuclear power plant.

(b) STATE AND LOCAL PLANS.—

(1) IN GENERAL.—Subsection (a) applies with respect to a

State or local government, subject to paragraph (2), if the government involved meets the following conditions:

(A) Such government submits to the President a plan

for the stockpiling of potassium iodide tablets, and for the

distribution and utilization of potassium iodide tablets in

the event of a nuclear incident.

(B) The plan is accompanied by certifications by such

government that the government has not already received

sufficient quantities of potassium iodide tablets from the

Federal Government.

(2) LOCAL GOVERNMENTS.—Subsection (a) applies with respect to a local government only if, in addition to the conditions

described in paragraph (1), the following conditions are met:

24

(A) The State in which the locality involved is

located—

(i) does not have a plan described in paragraph

(1)(A); or

(ii) has a plan described in such paragraph, but

the plan does not address populations at a distance

greater than 10 miles from the nuclear power plant involved.

(B) The local government has petitioned the State to

modify the State plan to address such populations, not exceeding 20 miles from such plant, and 60 days have

elapsed without the State modifying the State plan to address populations at the full distance sought by the local

government through the petition.

(C) The local government has submitted its local plan

under paragraph (1)(A) to the State, and the State has approved the plan and certified that the plan is not inconsistent with the State emergency plan.

(c) GUIDELINES.—Not later than one year after the date of the

enactment of this Act, the President, in consultation with individuals representing appropriate Federal, State, and local agencies,

shall establish guidelines for the stockpiling of potassium iodide

tablets, and for the distribution and utilization of potassium iodide

tablets in the event of a nuclear incident. Such tablets may not be

made available under subsection (a) until such guidelines have been

established.

(d) INFORMATION.—The President shall carry out activities to

inform State and local governments of the program under this section.

(e) REPORTS.— (1) PRESIDENT.—Not later than six months after the date

on which the guidelines under subsection (c) are issued, the

President shall submit to the Congress a report— (A) on whether potassium iodide tablets have been

made available under subsection (a) or other Federal,

State, or local programs, and the extent to which State and

local governments have established stockpiles of such tablets; and

(B) the measures taken by the President to implement

this section.

(2) NATIONAL ACADEMY OF SCIENCES.—

(A) IN GENERAL.—The President shall request the National Academy of Sciences to enter into an agreement with

the President under which the Academy conducts a study

to determine what is the most effective and safe way to distribute and administer potassium iodide tablets on a mass

scale. If the Academy declines to conduct the study, the

President shall enter into an agreement with another appropriate public or nonprofit private entity to conduct the

study.

(B) REPORT.—The President shall ensure that, not later

than six months after the date of the enactment of this Act,

the study required in subparagraph (A) is completed and a

report describing the findings made in the study is submitted to the Congress.

25

(f) APPLICABILITY.—Subsections (a) and (d) cease to apply as requirements if the President determines that there is an alternative

and more effective prophylaxis or preventive measures for adverse

thyroid conditions that may result from the release of radionuclides

from nuclear power plants.

Subtitle C—Improving State, Local, and

Hospital Preparedness for and Response

to Bioterrorism and Other Public Health

Emergencies

SEC. 131. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM AND

OTHER PUBLIC HEALTH EMERGENCIES.

(a) IN GENERAL.—Part B of title III of the Public Health Service

Act (42 U.S.C. 243 et seq.) is amended by inserting after section

319C the following sections:

‘‘SEC. 319C–1. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL

PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM

AND OTHER PUBLIC HEALTH EMERGENCIES.

‘‘(a) IN GENERAL.—To enhance the security of the United States

with respect to bioterrorism and other public health emergencies,

the Secretary shall make awards of grants or cooperative agreements to eligible entities to enable such entities to conduct the activities described in subsection (d).

‘‘(b) ELIGIBLE ENTITIES.—

‘‘(1) IN GENERAL.—To be eligible to receive an award under

subsection (a), an entity shall—

‘‘(A)(i) be a State; and

‘‘(ii) prepare and submit to the Secretary an application at such time, and in such manner, and containing

such information as the Secretary may require, including

an assurance that the State—

‘‘(I) has completed an evaluation under section

319B(a), or an evaluation that is substantially equivalent to an evaluation described in such section (as determined by the Secretary);

‘‘(II) has prepared, or will (within 60 days of receiving an award under this section) prepare, a Bioterrorism and Other Public Health Emergency Preparedness and Response Plan in accordance with subsection

(c);

‘‘(III) has established a means by which to obtain

public comment and input on the plan prepared under

subclause (II), and on the implementation of such plan,

that shall include an advisory committee or other similar mechanism for obtaining comment from the public

at large as well as from other State and local stakeholders;

‘‘(IV) will use amounts received under the award

in accordance with the plan prepared under subclause

(II), including making expenditures to carry out the

strategy contained in the plan; and

26

‘‘(V) with respect to the plan prepared under subclause (II), will establish reasonable criteria to evaluate

the effective performance of entities that receive funds

under the award and include relevant benchmarks in

the plan; or

‘‘(B)(i) be a political subdivision of a State or a consortium of 2 or more such subdivisions; and

‘‘(ii) prepare and submit to the Secretary an application at such time, and in such manner, and containing

such information as the Secretary may require.

‘‘(2) COORDINATION WITH STATEWIDE PLANS.—An award

under subsection (a) to an eligible entity described in paragraph

(1)(B) may not be made unless the application of such entity is

in coordination with, and consistent with, applicable Statewide

plans described in subsection (d)(1).

‘‘(c) BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCY

PREPAREDNESS AND RESPONSE PLAN.—Not later than 60 days after

receiving amounts under an award under subsection (a), an eligible

entity described in subsection (b)(1)(A) shall prepare and submit to

the Secretary a Bioterrorism and Other Public Health Emergency

Preparedness and Response Plan. Recognizing the assessment of

public health needs conducted under section 319B, such plan shall

include a description of activities to be carried out by the entity to

address the needs identified in such assessment (or an equivalent

assessment).

‘‘(d) USE OF FUNDS.—An award under subsection (a) may be expended for activities that may include the following and similar activities:

‘‘(1) To develop Statewide plans (including the development

of the Bioterrorism and Other Public Health Emergency Preparedness and Response Plan required under subsection (c)),

and community-wide plans for responding to bioterrorism and

other public health emergencies that are coordinated with the

capacities of applicable national, State, and local health agencies and health care providers, including poison control centers.

‘‘(2) To address deficiencies identified in the assessment

conducted under section 319B.

‘‘(3) To purchase or upgrade equipment (including stationary or mobile communications equipment), supplies, pharmaceuticals or other priority countermeasures to enhance preparedness for and response to bioterrorism or other public

health emergencies, consistent with the plan described in subsection (c).

‘‘(4) To conduct exercises to test the capability and timeliness of public health emergency response activities.

‘‘(5) To develop and implement the trauma care and burn

center care components of the State plans for the provision of

emergency medical services.

‘‘(6) To improve training or workforce development to enhance public health laboratories.

‘‘(7) To train public health and health care personnel to enhance the ability of such personnel—

‘‘(A) to detect, provide accurate identification of, and

recognize the symptoms and epidemiological characteristics

27

of exposure to a biological agent that may cause a public

health emergency; and ‘‘(B) to provide treatment to individuals who are exposed to such an agent.

‘‘(8) To develop, enhance, coordinate, or improve participation in systems by which disease detection and information

about biological attacks and other public health emergencies

can be rapidly communicated among national, State, and local

health agencies, emergency response personnel, and health care

providers and facilities to detect and respond to a bioterrorist

attack or other public health emergency, including activities to

improve information technology and communications equipment available to health care and public health officials for use

in responding to a biological threat or attack or other public

health emergency. ‘‘(9) To enhance communication to the public of information

on bioterrorism and other public health emergencies, including

through the use of 2-1-1 call centers. ‘‘(10) To address the health security needs of children and

other vulnerable populations with respect to bioterrorism and

other public health emergencies. ‘‘(11) To provide training and develop, enhance, coordinate,

or improve methods to enhance the safety of workers and workplaces in the event of bioterrorism. ‘‘(12) To prepare and plan for contamination prevention efforts related to public health that may be implemented in the

event of a bioterrorist attack, including training and planning

to protect the health and safety of workers conducting the activities described in this paragraph. ‘‘(13) To prepare a plan for triage and transport management in the event of bioterrorism or other public health emergencies. ‘‘(14) To enhance the training of health care professionals

to recognize and treat the mental health consequences of bioterrorism or other public health emergencies.

‘‘(15) To enhance the training of health care professionals

to assist in providing appropriate health care for large numbers

of individuals exposed to a bioweapon.

‘‘(16) To enhance training and planning to protect the

health and safety of personnel, including health care professionals, involved in responding to a biological attack.

‘‘(17) To improve surveillance, detection, and response activities to prepare for emergency response activities including

biological threats or attacks, including training personnel in

these and other necessary functions and including early warning and surveillance networks that use advanced information

technology to provide early detection of biological threats or attacks.

‘‘(18) To develop, enhance, and coordinate or improve the

ability of existing telemedicine programs to provide health care

information and advice as part of the emergency public health

response to bioterrorism or other public health emergencies.

Nothing in this subsection may be construed as establishing new

regulatory authority or as modifying any existing regulatory authority.

28

‘‘(e) PRIORITIES IN USE OF GRANTS.— ‘‘(1) IN GENERAL.— ‘‘(A) PRIORITIES.—Except as provided in subparagraph

(B), the Secretary shall, in carrying out the activities described in this section, address the following hazards in the

following priority: ‘‘(i) Bioterrorism or acute outbreaks of infectious

diseases. ‘‘(ii) Other public health threats and emergencies. ‘‘(B) DETERMINATION OF THE SECRETARY.—In the case

of the hazard involved, the degree of priority that would

apply to the hazard based on the categories specified in

clauses (i) and (ii) of subparagraph (A) may be modified by

the Secretary if the following conditions are met: ‘‘(i) The Secretary determines that the modification

is appropriate on the basis of the following factors: ‘‘(I) The extent to which eligible entities are

adequately prepared for responding to hazards

within the category specified in clause (i) of subparagraph (A). ‘‘(II) There has been a significant change in

the assessment of risks to the public health posed

by hazards within the category specified in clause

(ii) of such subparagraph.

‘‘(ii) Prior to modifying the priority, the Secretary

notifies the appropriate committees of the Congress of

the determination of the Secretary under clause (i) of

this subparagraph. ‘‘(2) AREAS OF EMPHASIS WITHIN CATEGORIES.—The Secretary shall determine areas of emphasis within the category of

hazards specified in clause (i) of paragraph (1)(A), and shall

determine areas of emphasis within the category of hazards

specified in clause (ii) of such paragraph, based on an assessment of the risk and likely consequences of such hazards and

on an evaluation of Federal, State, and local needs, and may

also take into account the extent to which receiving an award

under subsection (a) will develop capacities that can be used for

public health emergencies of varying types.

‘‘(f) CERTAIN ACTIVITIES.—In administering activities under section 319C(c)(4) or similar activities, the Secretary shall, where appropriate, give priority to activities that include State or local government financial commitments, that seek to incorporate multiple

public health and safety services or diagnostic databases into an integrated public health entity, and that cover geographic areas lacking advanced diagnostic and laboratory capabilities. ‘‘(g) COORDINATION WITH LOCAL MEDICAL RESPONSE SYSTEM.—

An eligible entity and local Metropolitan Medical Response Systems

shall, to the extent practicable, ensure that activities carried out

under an award under subsection (a) are coordinated with activities

that are carried out by local Metropolitan Medical Response Systems.‘‘(h) COORDINATION OF FEDERAL ACTIVITIES.—In making

awards under subsection (a), the Secretary shall— ‘‘(1) annually notify the Director of the Federal Emergency

Management Agency, the Director of the Office of Justice ProVerDate 11-MAY-2000 07:55 May 23, 2002 Jkt 099006 PO 00000 Frm 00032 Fmt 6659 Sfmt 6603 E:\HR\OC\HR481.XXX pfrm09 PsN: HR481
29

grams, and the Director of the National Domestic Preparedness

Office, as to the amount, activities covered under, and status of

such awards; and ‘‘(2) coordinate such awards with other activities conducted

or supported by the Secretary to enhance preparedness for bioterrorism and other public health emergencies.

‘‘(i) DEFINITION.—For purposes of this section, the term ‘eligible

entity’ means an entity that meets the conditions described in subparagraph (A) or (B) of subsection (b)(1). ‘‘(j) FUNDING.— ‘‘(1) AUTHORIZATIONS OF APPROPRIATIONS.— ‘‘(A) FISCAL YEAR 2003.— ‘‘(i) AUTHORIZATIONS.—For the purpose of carrying

out this section, there is authorized to be appropriated

$1,600,000,000 for fiscal year 2003, of which— ‘‘(I) $1,080,000,000 is authorized to be appropriated for awards pursuant to paragraph (3)

(subject to the authority of the Secretary to make

awards pursuant to paragraphs (4) and (5)); and ‘‘(II) $520,000,000 is authorized to be

appropriated— ‘‘(aa) for awards under subsection (a) to

States, notwithstanding the eligibility conditions under subsection (b), for the purpose of

enhancing the preparedness of hospitals (including children’s hospitals), clinics, health

centers, and primary care facilities for bioterrorism and other public health emergencies;

and ‘‘(bb) for Federal, State, and local planning and administrative activities related to

such purpose. ‘‘(ii) CONTINGENT ADDITIONAL AUTHORIZATION.—If

a significant change in circumstances warrants an increase in the amount authorized to be appropriated

under clause (i) for fiscal year 2003, there are authorized to be appropriated such sums as may be necessary

for such year for carrying out this section, in addition

to the amount authorized in clause (i).

‘‘(B) OTHER FISCAL YEARS.—For the purpose of carrying

out this section, there are authorized to be appropriated

such sums as may be necessary for each of the fiscal years

2004 through 2006.

‘‘(2) SUPPLEMENT NOT SUPPLANT.—Amounts appropriated

under paragraph (1) shall be used to supplement and not supplant other State and local public funds provided for activities

under this section.

‘‘(3) STATE BIOTERRORISM AND OTHER PUBLIC HEALTH

EMERGENCY PREPAREDNESS AND RESPONSE BLOCK GRANT FOR

FISCAL YEAR 2003.— ‘‘(A) IN GENERAL.—For fiscal year 2003, the Secretary

shall, in an amount determined in accordance with subparagraphs (B) through (D), make an award under subsection (a) to each State, notwithstanding the eligibility

conditions described in subsection (b), that submits to the

30

Secretary an application for the award that meets the criteria of the Secretary for the receipt of such an award and

that meets other implementation conditions established by

the Secretary for such awards. No other awards may be

made under subsection (a) for such fiscal year, except as

provided in paragraph (1)(A)(i)(II) and paragraphs (4) and

(5). ‘‘(B) BASE AMOUNT.—In determining the amount of an

award pursuant to subparagraph (A) for a State, the Secretary shall first determine an amount the Secretary considers appropriate for the State (referred to in this paragraph as the ‘base amount’), except that such amount may

not be greater than the minimum amount determined

under subparagraph (D). ‘‘(C) INCREASE ON BASIS OF POPULATION.—After determining the base amount for a State under subparagraph

(B), the Secretary shall increase the base amount by an

amount equal to the product of— ‘‘(i) the amount appropriated under paragraph

(1)(A)(i)(I) for the fiscal year, less an amount equal to

the sum of all base amounts determined for the States

under subparagraph (B), and less the amount, if any,

reserved by the Secretary under paragraphs (4) and (5);

and ‘‘(ii) subject to paragraph (4)(C), the percentage

constituted by the ratio of an amount equal to the population of the State over an amount equal to the total

population of the States (as indicated by the most recent data collected by the Bureau of the Census).

‘‘(D) MINIMUM AMOUNT.—Subject to the amount appropriated under paragraph (1)(A)(i)(I), an award pursuant to

subparagraph (A) for a State shall be the greater of the

base amount as increased under subparagraph (C), or the

minimum amount under this subparagraph. The minimum

amount under this subparagraph is—

‘‘(i) in the case of each of the several States, the

District of Columbia, and the Commonwealth of Puerto

Rico, an amount equal to the lesser of—

‘‘(I) $5,000,000; or

‘‘(II) if the amount appropriated under paragraph (1)(A)(i)(I) is less than $667,000,000, an

amount equal to 0.75 percent of the amount appropriated under such paragraph, less the amount, if

any, reserved by the Secretary under paragraphs

(4) and (5); or

‘‘(ii) in the case of each of American Samoa, Guam,

the Commonwealth of the Northern Mariana Islands,

and the Virgin Islands, an amount determined by the

Secretary to be appropriate, except that such amount

may not exceed the amount determined under clause

(i).

‘‘(4) CERTAIN POLITICAL SUBDIVISIONS.— ‘‘(A) IN GENERAL.—For fiscal year 2003, the Secretary

may, before making awards pursuant to paragraph (3) for

such year, reserve from the amount appropriated under

31

paragraph (1)(A)(i)(I) for the year an amount determined

necessary by the Secretary to make awards under subsection (a) to political subdivisions that have a substantial

number of residents, have a substantial local infrastructure

for responding to public health emergencies, and face a

high degree of risk from bioterrorist attacks or other public

health emergencies. Not more than three political subdivisions may receive awards pursuant to this subparagraph. ‘‘(B) COORDINATION WITH STATEWIDE PLANS.—An

award pursuant to subparagraph (A) may not be made unless the application of the political subdivision involved is

in coordination with, and consistent with, applicable Statewide plans described in subsection (c)(1). ‘‘(C) RELATIONSHIP TO FORMULA GRANTS.—In the case

of a State that will receive an award pursuant to paragraph (3), and in which there is located a political subdivision that will receive an award pursuant to subparagraph

(A), the Secretary shall, in determining the amount under

paragraph (3)(B) for the State, subtract from the population of the State an amount equal to the population of

such political subdivision. ‘‘(D) CONTINUITY OF FUNDING.—In determining whether to make an award pursuant to subparagraph (A) to a political subdivision, the Secretary may consider, as a factor

indicating that the award should be made, that the political subdivision received public health funding from the

Secretary for fiscal year 2002.

‘‘(5) SIGNIFICANT UNMET NEEDS; DEGREE OF RISK.— ‘‘(A) IN GENERAL.—For fiscal year 2003, the Secretary

may, before making awards pursuant to paragraph (3) for

such year, reserve from the amount appropriated under

paragraph (1)(A)(i)(I) for the year an amount determined

necessary by the Secretary to make awards under subsection (a) to eligible entities that—

‘‘(i) have a significant need for funds to build capacity to identify, detect, monitor, and respond to a bioterrorist or other threat to the public health, which

need will not be met by awards pursuant to paragraph

(3); and

‘‘(ii) face a particularly high degree of risk of such

a threat.

‘‘(B) RECIPIENTS OF GRANTS.—Awards pursuant to subparagraph (A) may be supplemental awards to States that

receive awards pursuant to paragraph (3), or may be

awards to eligible entities described in subsection (b)(1)(B)

within such States.

‘‘(C) FINDING WITH RESPECT TO DISTRICT OF COLUM- BIA.—The Secretary shall consider the District of Columbia

to have a significant unmet need for purposes of subparagraph (A), and to face a particularly high degree of risk for

such purposes, on the basis of the concentration of entities

of national significance located within the District.

‘‘(6) FUNDING OF LOCAL ENTITIES.—For fiscal year 2003, the

Secretary shall in making awards under this section ensure

that appropriate portions of such awards are made available to

32

political subdivisions, local departments of public health, hospitals (including children’s hospitals), clinics, health centers, or

primary care facilities, or consortia of such entities.

‘‘SEC. 319C–2. PARTNERSHIPS FOR COMMUNITY AND HOSPITAL PREPAREDNESS.

‘‘(a) GRANTS.—The Secretary shall make awards of grants or

cooperative agreements to eligible entities to enable such entities to

improve community and hospital preparedness for bioterrorism and

other public health emergencies. ‘‘(b) ELIGIBILITY.—To be eligible for an award under subsection

(a), an entity shall— ‘‘(1) be a partnership consisting of— ‘‘(A) one or more hospitals (including children’s hospitals), clinics, health centers, or primary care facilities;

and ‘‘(B)(i) one or more political subdivisions of States;

‘‘(ii) one or more States; or

‘‘(iii) one or more States and one or more political subdivisions of States; and

‘‘(2) prepare, in consultation with the Chief Executive Officer of the State, District, or territory in which the hospital, clinic, health center, or primary care facility described in paragraph (1)(A) is located, and submit to the Secretary, an application at such time, in such manner, and containing such information as the Secretary may require.

‘‘(c) REGIONAL COORDINATION.—In making awards under subsection (a), the Secretary shall give preference to eligible entities that

submit applications that, in the determination of the Secretary,

will—

‘‘(1) enhance coordination—

‘‘(A) among the entities described in subsection

(b)(1)(A); and

‘‘(B) between such entities and the entities described in

subsection (b)(1)(B); and

‘‘(2) serve the needs of a defined geographic area.

‘‘(d) CONSISTENCY OF PLANNED ACTIVITIES.—An entity described in subsection (b)(1) shall utilize amounts received under an

award under subsection (a) in a manner that is coordinated and

consistent, as determined by the Secretary, with an applicable State

Bioterrorism and Other Public Health Emergency Preparedness and

Response Plan.

‘‘(e) USE OF FUNDS.—An award under subsection (a) may be expended for activities that may include the following and similar

activities—

‘‘(1) planning and administration for such award;

‘‘(2) preparing a plan for triage and transport management

in the event of bioterrorism or other public health emergencies;

‘‘(3) enhancing the training of health care professionals to

improve the ability of such professionals to recognize the symptoms of exposure to a potential bioweapon, to make appropriate

diagnosis, and to provide treatment to those individuals so exposed;

‘‘(4) enhancing the training of health care professionals to

recognize and treat the mental health consequences of bioterrorism or other public health emergencies;

33

‘‘(5) enhancing the training of health care professionals to

assist in providing appropriate health care for large numbers of

individuals exposed to a bioweapon;

‘‘(6) enhancing training and planning to protect the health

and safety of personnel involved in responding to a biological

attack;

‘‘(7) developing and implementing the trauma care and

burn center care components of the State plans for the provision

of emergency medical services; or

‘‘(8) conducting such activities as are described in section

319C–1(d) that are appropriate for hospitals (including children’s hospitals), clinics, health centers, or primary care facilities.

‘‘(f) LIMITATION ON AWARDS.—A political subdivision of a State

shall not participate in more than one partnership described in subsection (b)(1).

‘‘(g) PRIORITIES IN USE OF GRANTS.—

‘‘(1) IN GENERAL.—

‘‘(A) PRIORITIES.—Except as provided in subparagraph

(B), the Secretary shall, in carrying out the activities described in this section, address the following hazards in the

following priority:

‘‘(i) Bioterrorism or acute outbreaks of infectious

diseases.

‘‘(ii) Other public health threats and emergencies.

‘‘(B) DETERMINATION OF THE SECRETARY.—In the case

of the hazard involved, the degree of priority that would

apply to the hazard based on the categories specified in

clauses (i) and (ii) of subparagraph (A) may be modified by

the Secretary if the following conditions are met:

‘‘(i) The Secretary determines that the modification

is appropriate on the basis of the following factors:

‘‘(I) The extent to which eligible entities are

adequately prepared for responding to hazards

within the category specified in clause (i) of subparagraph (A).

‘‘(II) There has been a significant change in

the assessment of risks to the public health posed

by hazards within the category specified in clause

(ii) of such subparagraph.

‘‘(ii) Prior to modifying the priority, the Secretary

notifies the appropriate committees of the Congress of

the determination of the Secretary under clause (i) of

this subparagraph.

‘‘(2) AREAS OF EMPHASIS WITHIN CATEGORIES.—The Secretary shall determine areas of emphasis within the category of

hazards specified in clause (i) of paragraph (1)(A), and shall

determine areas of emphasis within the category of hazards

specified in clause (ii) of such paragraph, based on an assessment of the risk and likely consequences of such hazards and

on an evaluation of Federal, State, and local needs, and may

also take into account the extent to which receiving an award

under subsection (a) will develop capacities that can be used for

public health emergencies of varying types.

34

‘‘(h) COORDINATION WITH LOCAL MEDICAL RESPONSE SYSTEM.—

An eligible entity and local Metropolitan Medical Response Systems

shall, to the extent practicable, ensure that activities carried out

under an award under subsection (a) are coordinated with activities

that are carried out by local Metropolitan Medical Response Systems.

‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, there are authorized to be appropriated

such sums as may be necessary for each of fiscal years 2004 through

2006.’’.

(b) CERTAIN GRANTS.—Section 319C of the Public Health Service Act (42 U.S.C. 247d–3) is amended by striking subsection (f).

Subtitle D—Emergency Authorities;

Additional Provisions

SEC. 141. REPORTING DEADLINES.

Section 319 of the Public Health Service Act (42 U.S.C. 247d)

is amended by adding at the end the following:

‘‘(d) DATA SUBMITTAL AND REPORTING DEADLINES.—In any case

in which the Secretary determines that, wholly or partially as a result of a public health emergency that has been determined pursuant to subsection (a), individuals or public or private entities are

unable to comply with deadlines for the submission to the Secretary

of data or reports required under any law administered by the Secretary, the Secretary may, notwithstanding any other provision of

law, grant such extensions of such deadlines as the circumstances

reasonably require, and may waive, wholly or partially, any sanctions otherwise applicable to such failure to comply. Before or

promptly after granting such an extension or waiver, the Secretary

shall notify the Congress of such action and publish in the Federal

Register a notice of the extension or waiver.’’.

SEC. 142. STREAMLINING AND CLARIFYING COMMUNICABLE DISEASE

QUARANTINE PROVISIONS.

(a) ELIMINATION OF PREREQUISITE FOR NATIONAL ADVISORY

HEALTH COUNCIL RECOMMENDATION BEFORE ISSUING QUARANTINE

RULES.—

(1) EXECUTIVE ORDERS SPECIFYING DISEASES SUBJECT TO

INDIVIDUAL DETENTIONS.—Section 361(b) of the Public Health

Act (42 U.S.C. 264(b)) is amended by striking ‘‘Executive orders

of the President upon the recommendation of the National Advisory Health Council and the Surgeon General’’ and inserting

‘‘Executive orders of the President upon the recommendation of

the Secretary, in consultation with the Surgeon General,’’.

(2) REGULATIONS PROVIDING FOR APPREHENSION OF INDIVIDUALS.—Section 361(d) of the Public Health Act (42 U.S.C.

264(d)) is amended by striking ‘‘On recommendation of the National Advisory Health Council, regulations’’ and inserting

‘‘Regulations’’.

(3) REGULATIONS PROVIDING FOR APPREHENSION OF INDIVIDUALS IN WARTIME.—Section 363 of the Public Health Act (42

U.S.C. 266) is amended by striking ‘‘the Surgeon General, on

recommendation of the National Advisory Health Council,’’ and

35

inserting ‘‘the Secretary, in consultation with the Surgeon General,’’.

(b) APPREHENSION AUTHORITY TO APPLY IN CASES OF EXPOSURE TO DISEASE.—

(1) REGULATIONS PROVIDING FOR APPREHENSION OF INDIVIDUALS.—Section 361(d) of the Public Health Act (42 U.S.C.

264(d)), as amended by subsection (a)(2), is further amended—

(A) by striking ‘‘(1)’’ and ‘‘(2)’’ and inserting ‘‘(A)’’ and

‘‘(B)’’, respectively;

(B) by striking ‘‘(d)’’ and inserting ‘‘(d)(1)’’;

(C) in paragraph (1) (as designated by subparagraph

(B) of this paragraph), in the first sentence, by striking ‘‘in

a communicable stage’’ each place such term appears and

inserting ‘‘in a qualifying stage’’; and

(D) by adding at the end the following paragraph:

‘‘(2) For purposes of this subsection, the term ‘qualifying stage’,

with respect to a communicable disease, means that such disease—

‘‘(A) is in a communicable stage; or

‘‘(B) is in a precommunicable stage, if the disease would be

likely to cause a public health emergency if transmitted to other

individuals.’’.

(2) REGULATIONS PROVIDING FOR APPREHENSION OF INDIVIDUALS IN WARTIME.—Section 363 of the Public Health Act (42

U.S.C. 266), as amended by subsection (a)(3), is further amended by striking ‘‘in a communicable stage’’.

(c) STATE AUTHORITY.—Section 361 of the Public Health Act (42

U.S.C. 264) is amended by adding at the end the following:

‘‘(e) Nothing in this section or section 363, or the regulations

promulgated under such sections, may be construed as superseding

any provision under State law (including regulations and including

provisions established by political subdivisions of States), except to

the extent that such a provision conflicts with an exercise of Federal

authority under this section or section 363.’’.

SEC. 143. EMERGENCY WAIVER OF MEDICARE, MEDICAID, AND SCHIP

REQUIREMENTS.

(a) WAIVER AUTHORITY.—Title XI of the Social Security Act (42

U.S.C. 1301 et seq.) is amended by inserting after section 1134 the

following new section:

‘‘AUTHORITY TO WAIVE REQUIREMENTS DURING NATIONAL

EMERGENCIES

‘‘SEC. 1135. (a) PURPOSE.—The purpose of this section is to enable the Secretary to ensure to the maximum extent feasible, in any

emergency area and during an emergency period (as defined in subsection (g)(1))—

‘‘(1) that sufficient health care items and services are available to meet the needs of individuals in such area enrolled in

the programs under titles XVIII, XIX, and XXI; and

‘‘(2) that health care providers (as defined in subsection

(g)(2)) that furnish such items and services in good faith, but

that are unable to comply with one or more requirements described in subsection (b), may be reimbursed for such items and

services and exempted from sanctions for such noncompliance,

absent any determination of fraud or abuse.

36

‘‘(b) SECRETARIAL AUTHORITY.—To the extent necessary to accomplish the purpose specified in subsection (a), the Secretary is authorized, subject to the provisions of this section, to temporarily

waive or modify the application of, with respect to health care items

and services furnished by a health care provider (or classes of

health care providers) in any emergency area (or portion of such an

area) during any portion of an emergency period, the requirements

of titles XVIII, XIX, or XXI, or any regulation thereunder (and the

requirements of this title other than this section, and regulations

thereunder, insofar as they relate to such titles), pertaining to— ‘‘(1)(A) conditions of participation or other certification requirements for an individual health care provider or types of

providers, ‘‘(B) program participation and similar requirements for an

individual health care provider or types of providers, and ‘‘(C) pre-approval requirements;

‘‘(2) requirements that physicians and other health care

professionals be licensed in the State in which they provide

such services, if they have equivalent licensing in another State

and are not affirmatively excluded from practice in that State

or in any State a part of which is included in the emergency

area;

‘‘(3) sanctions under section 1867 (relating to examination

and treatment for emergency medical conditions and women in

labor) for a transfer of an individual who has not been stabilized in violation of subsection (c) of such section if the transfer arises out of the circumstances of the emergency;

‘‘(4) sanctions under section 1877(g) (relating to limitations

on physician referral);

‘‘(5) deadlines and timetables for performance of required

activities, except that such deadlines and timetables may only

be modified, not waived; and

‘‘(6) limitations on payments under section 1851(i) for

health care items and services furnished to individuals enrolled

in a Medicare+Choice plan by health care professionals or facilities not included under such plan.

Insofar as the Secretary exercises authority under paragraph (6)

with respect to individuals enrolled in a Medicare+Choice plan, to

the extent possible given the circumstances, the Secretary shall reconcile payments made on behalf of such enrollees to ensure that the

enrollees do not pay more than would be required had they received

services from providers within the network of the plan and may reconcile payments to the organization offering the plan to ensure that

such organization pays for services for which payment is included

in the capitation payment it receives under part C of title XVIII. ‘‘(c) AUTHORITY FOR RETROACTIVE WAIVER.—A waiver or modification of requirements pursuant to this section may, at the Secretary’s discretion, be made retroactive to the beginning of the emergency period or any subsequent date in such period specified by the

Secretary.

‘‘(d) CERTIFICATION TO CONGRESS.—The Secretary shall provide

a certification and advance written notice to the Congress at least

two days before exercising the authority under this section with respect to an emergency area. Such a certification and notice shall

include—

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‘‘(1) a description of—

‘‘(A) the specific provisions that will be waived or modified;

‘‘(B) the health care providers to whom the waiver or

modification will apply;

‘‘(C) the geographic area in which the waiver or modification will apply; and

‘‘(D) the period of time for which the waiver or modification will be in effect; and

‘‘(2) a certification that the waiver or modification is necessary to carry out the purpose specified in subsection (a).

‘‘(e) DURATION OF WAIVER.—

‘‘(1) IN GENERAL.—A waiver or modification of requirements

pursuant to this section terminates upon—

‘‘(A) the termination of the applicable declaration of

emergency or disaster described in subsection (g)(1)(A);

‘‘(B) the termination of the applicable declaration of

public health emergency described in subsection (g)(1)(B);

or

‘‘(C) subject to paragraph (2), the termination of a period of 60 days from the date the waiver or modification is

first published (or, if applicable, the date of extension of the

waiver or modification under paragraph (2)).

‘‘(2) EXTENSION OF 60-DAY PERIODS.—The Secretary may, by

notice, provide for an extension of a 60-day period described in

paragraph (1)(C) (or an additional period provided under this

paragraph) for additional period or periods (not to exceed, except as subsequently provided under this paragraph, 60 days

each), but any such extension shall not affect or prevent the termination of a waiver or modification under subparagraph (A)

or (B) of paragraph (1).

‘‘(f) REPORT TO CONGRESS.—Within one year after the end of the

emergency period in an emergency area in which the Secretary exercised the authority provided under this section, the Secretary shall

report to the Congress regarding the approaches used to accomplish

the purposes described in subsection (a), including an evaluation of

such approaches and recommendations for improved approaches

should the need for such emergency authority arise in the future.

‘‘(g) DEFINITIONS.—For purposes of this section:

‘‘(1) EMERGENCY AREA; EMERGENCY PERIOD.—An ‘emergency

area’ is a geographical area in which, and an ‘emergency period’ is the period during which, there exists—

‘‘(A) an emergency or disaster declared by the President

pursuant to the National Emergencies Act or the Robert T.

Stafford Disaster Relief and Emergency Assistance Act; and

‘‘(B) a public health emergency declared by the Secretary pursuant to section 319 of the Public Health Service

Act.

‘‘(2) HEALTH CARE PROVIDER.—The term ‘health care provider’ means any entity that furnishes health care items or services, and includes a hospital or other provider of services, a

physician or other health care practitioner or professional, a

health care facility, or a supplier of health care items or services.’’.

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(b) EFFECTIVE DATE.—The amendment made by subsection (a)

shall be effective on and after September 11, 2001.

SEC. 144. PROVISION FOR EXPIRATION OF PUBLIC HEALTH EMERGENCIES.

(a) IN GENERAL.—Section 319(a) of the Public Health Service

Act (42 U.S.C. 247d(a)), is amended by adding at the end the following new sentence: ‘‘Any such determination of a public health

emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period

beginning on the date on which the determination is made by the

Secretary, whichever occurs first. Determinations that terminate

under the preceding sentence may be renewed by the Secretary (on

the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after

making a determination under this subsection of a public health

emergency (including a renewal), the Secretary shall submit to the

Congress written notification of the determination.’’.

(b) APPLICABILITY.—The amendment made by subsection (a) applies to any public health emergency under section 319(a) of the

Public Health Service Act, including any such emergency that was

in effect as of the day before the date of the enactment of this Act.

In the case of such an emergency that was in effect as of such day,

the 90-day period described in such section with respect to the termination of the emergency is deemed to begin on such date of enactment.

Subtitle E—Additional Provisions

SEC. 151. DESIGNATED STATE PUBLIC EMERGENCY ANNOUNCEMENT

PLAN.

Section 613(b) of the Robert T. Stafford Disaster Relief and

Emergency Assistance Act (42 U.S.C. 5196b(b)) is amended—

(1) in paragraph (5), by striking ‘‘and’’ at the end;

(2) in paragraph (6), by striking the period and inserting

‘‘; and’’; and

(3) by adding at the end the following:

‘‘(7) include a plan for providing information to the public

in a coordinated manner.’’.

SEC. 152. EXPANDED RESEARCH BY SECRETARY OF ENERGY.

(a) DETECTION AND IDENTIFICATION RESEARCH.—

(1) IN GENERAL.—In conjunction with the working group

under section 319F(a) of the Public Health Service Act, the Secretary of Energy and the Administrator of the National Nuclear

Security Administration shall expand, enhance, and intensify

research relevant to the rapid detection and identification of

pathogens likely to be used in a bioterrorism attack or other

agents that may cause a public health emergency.

(2) AUTHORIZED ACTIVITIES.—Activities carried out under

paragraph (1) may include—

(A) the improvement of methods for detecting biological

agents or toxins of potential use in a biological attack and

the testing of such methods under variable conditions;

39

(B) the improvement or pursuit of methods for testing,

verifying, and calibrating new detection and surveillance

tools and techniques; and

(C) carrying out other research activities in relevant

areas.

(3) REPORT.—Not later than 180 days after the date of the

enactment of this Act, the Administrator of the National Nuclear Security Administration shall submit to the Committee on

Energy and Natural Resources and the Committee on Armed

Services of the Senate, and the Committee on Energy and Commerce and the Committee on Armed Services of the House of

Representatives, a report setting forth the programs and

projects that will be funded prior to the obligation of funds appropriated under subsection (b).

(b) AUTHORIZATION.—For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be

necessary in each of fiscal years 2002 through 2006.

SEC. 153. EXPANDED RESEARCH ON WORKER HEALTH AND SAFETY.

The Secretary of Health and Human Services (referred to in

this section as the ‘‘Secretary’’), acting through the Director of the

National Institute of Occupational Safety and Health, shall enhance

and expand research as deemed appropriate on the health and safety of workers who are at risk for bioterrorist threats or attacks in

the workplace, including research on the health effects of measures

taken to treat or protect such workers for diseases or disorders resulting from a bioterrorist threat or attack. Nothing in this section

may be construed as establishing new regulatory authority for the

Secretary or the Director to issue or modify any occupational safety

and health rule or regulation.

SEC. 154. ENHANCEMENT OF EMERGENCY PREPAREDNESS OF DEPARTMENT OF VETERANS AFFAIRS.

(a) READINESS OF DEPARTMENT MEDICAL CENTER.—(1) The

Secretary of Veterans Affairs shall take appropriate actions to enhance the readiness of Department of Veterans Affairs medical centers to protect the patients and staff of such centers from chemical

or biological attack or otherwise to respond to such an attack and

so as to enable such centers to fulfil their obligations as part of the

Federal response to public health emegencies.

(2) Actions under paragraph (1) shall include—

(A) the provision of decontamination equipment and personal protection equipment at Department medical centers; and

(B) the provision of training in the use of such equipment

to staff of such centers.

(b) SECURITY AT DEPARTMENT MEDICAL AND RESEARCH FACILITIES.—(1) Not later than 180 days after the date of the enactment

of this Act, the Secretary shall carry out an evaluation of the security needs at Department medical centers and research facilities.

The evaluation shall address the following needs:

(A) Needs for the protection of patients and medical staff

during emergencies, including a chemical or biological attack or

other terrorist attack.

(B) Needs, if any, for screening personnel engaged in research relating to biological pathogens or agents, including

work associated with such research.

40

(C) Needs for securing laboratories or other facilities engaged in research relating to biological pathogens or agents.

(D) Any other needs the Secretary considers appropriate.

(2) The Secretary shall take appropriate actions to enhance the

security of Department medical centers and research facilities, including staff and patients at such centers and facilities. In taking

such actions, the Secretary shall take into account the results of the

evaluation required by paragraph (1).

(c) TRACKING OF PHARMACEUTICALS AND MEDICAL SUPPLIES

AND EQUIPMENT.—The Secretary shall develop and maintain a centralized system for tracking the current location and availability of

pharmaceuticals, medical supplies, and medical equipment throughout the Department health care system in order to permit the ready

identification and utilization of such pharmaceuticals, supplies, and

equipment for a variety of purposes, including response to a chemical or biological attack or other terrorist attack.

(d) TRAINING.—The Secretary shall ensure that the Department

medical centers, in consultation with the accredited medical school

affiliates of such medical centers, develop and implement curricula

to train resident physicians and health care personnel in medical

matters relating to biological, chemical, or radiological attacks.

(e) PARTICIPATION IN NATIONAL DISASTER MEDICAL SYSTEM.— (1) The Secretary shall, in consultation with the Secretary of Defense, the Secretary of Health and Human Services, and the Director of the Federal Emergency Management Agency, establish and

maintain a training program to facilitate the participation of the

staff of Department medical centers, and of the community partners

of such centers, in the National Disaster Medical System.

(2) The Secretary shall establish and maintain the training program under paragraph (1) in accordance with the recommendations

of the working group under section 319F(a) of the Public Health

Service Act.

(f) MENTAL HEALTH COUNSELING.—(1) With respect to activities

conducted by personnel serving at Department medical centers, the

Secretary shall, in consultation with the Secretary of Health and

Human Services, the American Red Cross, and the working group

under section 319F(a) of the Public Health Service Act, develop and

maintain various strategies for providing mental health counseling

and assistance, including counseling and assistance for post-traumatic stress disorder, to local and community emergency response

providers, veterans, active duty military personnel, and individuals

seeking care at Department medical centers following a bioterrorist

attack or other public health emergency.

(2) The strategies under paragraph (1) shall include the following:

(A) Training and certification of providers of mental health

counseling and assistance.

(B) Mechanisms for coordinating the provision of mental

health counseling and assistance to emergency response providers referred to in that paragraph.

(g) AUTHORIZATION OF APPROPRIATIONS.—There is hereby authorized to be appropriated for the Department of Veterans Affairs

amounts as follows:

(1) To carry out activities required by subsection (a)—

(A) $100,000,000 for fiscal year 2002; and

41

(B) such sums as may be necessary for each of fiscal

years 2003 through 2006.

(2) To carry out activities required by subsections (b)

through (f)—(A) $33,000,000 for fiscal year 2002; and

(B) such sums as may be necessary for each of fiscal

years 2003 through 2006.

SEC. 155. REAUTHORIZATION OF EXISTING PROGRAM.

Section 582(f) of the Public Health Service Act (42 U.S.C.

290hh-1(f)) is amended by striking ‘‘2002 and 2003’’ and inserting ‘‘2003 through 2006’’.

SEC. 156. SENSE OF CONGRESS.

It is the sense of the Congress that— (1) many excellent university-based programs are already

functioning and developing important biodefense products and

solutions throughout the United States;

(2) accelerating the crucial work done at university centers

and laboratories will contribute significantly to the United

States capacity to defend against any biological threat or attack;

(3) maximizing the effectiveness of, and extending the mission of, established university programs would be one appropriate use of the additional resources provided for in this Act

and the amendments made by this Act; and

(4) the Secretary of Health and Human Services should, as

appropriate, recognize the importance of existing public and

private university-based research, training, public awareness,

and safety related biological defense programs when the Secretary makes awards of grants and contracts in accordance

with this Act and the amendments made by this Act.

SEC. 157. GENERAL ACCOUNTING OFFICE REPORT.

(a) IN GENERAL.—The Comptroller General shall submit to the

Committee on Health, Education, Labor, and Pensions and the

Committee on Appropriations of the Senate, and to the Committee

on Energy and Commerce and the Committee on Appropriations of

the House of Representatives, a report that describes—

(1) Federal activities primarily related to research on, preparedness for, and the management of the public health and

medical consequences of a bioterrorist attack against the civilian population;

(2) the coordination of the activities described in paragraph

(1);

(3) the effectiveness of such efforts in preparing national,

State, and local authorities to address the public health and

medical consequences of a potential bioterrorist attack against

the civilian population;

(4) the activities and costs of the Civil Support Teams of

the National Guard in responding to biological threats or attacks against the civilian population;

(5) the activities of the working group under subsection (a)

and the efforts made by such group to carry out the activities

described in such subsection; and

(6) the ability of private sector contractors to enhance governmental responses to biological threats or attacks.

42

SEC. 158. CERTAIN AWARDS.

Section 319(a) of the Public Health Service Act (42 U.S.C.

247d(a)) is amended in the matter after and below paragraph (2)

by striking ‘‘grants and’’ and inserting ‘‘grants, providing awards

for expenses, and’’

SEC. 159. PUBLIC ACCESS DEFIBRILLATION PROGRAMS AND PUBLIC

ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.

(a) SHORT TITLE.—This section may be cited as the ‘‘Community Access to Emergency Defibrillation Act of 2002’’.

(b) FINDINGS.—Congress makes the following findings:

(1) Over 220,000 Americans die each year from cardiac arrest. Every 2 minutes, an individual goes into cardiac arrest in

the United States.

(2) The chance of successfully returning to a normal heart

rhythm diminishes by 10 percent each minute following sudden

cardiac arrest.

(3) Eighty percent of cardiac arrests are caused by ventricular fibrillation, for which defibrillation is the only effective

treatment.

(4) Sixty percent of all cardiac arrests occur outside the

hospital. The average national survival rate for out-of-hospital

cardiac arrest is only 5 percent.

(5) Communities that have established and implemented

public access defibrillation programs have achieved average

survival rates for out-of-hospital cardiac arrest as high as 50

percent.

(6) According to the American Heart Association, wide use

of defibrillators could save as many as 50,000 lives nationally

each year.

(7) Successful public access defibrillation programs ensure

that cardiac arrest victims have access to early 911 notification,

early cardiopulmonary resuscitation, early defibrillation, and

early advanced care.

(c) PUBLIC ACCESS DEFIBRILLATION PROGRAMS AND

PROJECTS.—Part B of title III of the Public Health Service Act (42

U.S.C. 243 et seq.), as amended by Public Law 106–310, is amended

by adding after section 311 the following:

‘‘SEC. 312. PUBLIC ACCESS DEFIBRILLATION PROGRAMS.

‘‘(a) IN GENERAL.—The Secretary shall award grants to States,

political subdivisions of States, Indian tribes, and tribal organizations to develop and implement public access defibrillation

programs—

‘‘(1) by training and equipping local emergency medical

services personnel, including firefighters, police officers, paramedics, emergency medical technicians, and other first responders, to administer immediate care, including cardiopulmonary

resuscitation and automated external defibrillation, to cardiac

arrest victims;

‘‘(2) by purchasing automated external defibrillators, placing the defibrillators in public places where cardiac arrests are

likely to occur, and training personnel in such places to administer cardiopulmonary resuscitation and automated external

defibrillation to cardiac arrest victims;

43

‘‘(3) by setting procedures for proper maintenance and testing of such devices, according to the guidelines of the manufacturers of the devices;

‘‘(4) by providing training to members of the public in

cardiopulmonary resuscitation and automated external

defibrillation;

‘‘(5) by integrating the emergency medical services system

with the public access defibrillation programs so that emergency medical services personnel, including dispatchers, are informed about the location of automated external defibrillators

in their community; and

‘‘(6) by encouraging private companies, including small

businesses, to purchase automated external defibrillators and

provide training for their employees to administer

cardiopulmonary resuscitation and external automated

defibrillation to cardiac arrest victims in their community.

‘‘(b) PREFERENCE.—In awarding grants under subsection (a),

the Secretary shall give a preference to a State, political subdivision

of a State, Indian tribe, or tribal organization that—

‘‘(1) has a particularly low local survival rate for cardiac

arrests, or a particularly low local response rate for cardiac arrest victims; or

‘‘(2) demonstrates in its application the greatest commitment to establishing and maintaining a public access

defibrillation program.

‘‘(c) USE OF FUNDS.—A State, political subdivision of a State,

Indian tribe, or tribal organization that receives a grant under subsection (a) may use funds received through such grant to—

‘‘(1) purchase automated external defibrillators that have

been approved, or cleared for marketing, by the Food and Drug

Administration;

‘‘(2) provide automated external defibrillation and basic life

support training in automated external defibrillator usage

through nationally recognized courses;

‘‘(3) provide information to community members about the

public access defibrillation program to be funded with the

grant;

‘‘(4) provide information to the local emergency medical

services system regarding the placement of automated external

defibrillators in public places;

‘‘(5) produce materials to encourage private companies, including small businesses, to purchase automated external

defibrillators; and

‘‘(6) further develop strategies to improve access to automated external defibrillators in public places.

‘‘(d) APPLICATION.—

‘‘(1) IN GENERAL.—To be eligible to receive a grant under

subsection (a), a State, political subdivision of a State, Indian

tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.

‘‘(2) CONTENTS.—An application submitted under paragraph (1) shall—

44

‘‘(A) describe the comprehensive public access

defibrillation program to be funded with the grant and

demonstrate how such program would make automated external defibrillation accessible and available to cardiac arrest victims in the community; ‘‘(B) contain procedures for implementing appropriate

nationally recognized training courses in performing

cardiopulmonary resuscitation and the use of automated

external defibrillators; ‘‘(C) contain procedures for ensuring direct involvement

of a licensed medical professional and coordination with

the local emergency medical services system in the oversight

of training and notification of incidents of the use of the

automated external defibrillators; ‘‘(D) contain procedures for proper maintenance and

testing of the automated external defibrillators, according

to the labeling of the manufacturer; ‘‘(E) contain procedures for ensuring notification of

local emergency medical services system personnel, including dispatchers, of the location and type of devices used in

the public access defibrillation program; and

‘‘(F) provide for the collection of data regarding the effectiveness of the public access defibrillation program to be

funded with the grant in affecting the out-of-hospital cardiac arrest survival rate.

‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, there are authorized to be appropriated

$25,000,000 for fiscal year 2003, and such sums as may be necessary for each of the fiscal years 2004 through 2006. Not more than

10 percent of amounts received under a grant awarded under this

section may be used for administrative expenses.

‘‘SEC. 313. PUBLIC ACCESS DEFIBRILLATION DEMONSTRATION

PROJECTS.

‘‘(a) IN GENERAL.—The Secretary shall award grants to political subdivisions of States, Indian tribes, and tribal organizations

to develop and implement innovative, comprehensive, communitybased public access defibrillation demonstration projects that—

‘‘(1) provide cardiopulmonary resuscitation and automated

external defibrillation to cardiac arrest victims in unique settings;

‘‘(2) provide training to community members in

cardiopulmonary resuscitation and automated external

defibrillation; and

‘‘(3) maximize community access to automated external

defibrillators.

‘‘(b) USE OF FUNDS.—A recipient of a grant under subsection (a)

shall use the funds provided through the grant to—

‘‘(1) purchase automated external defibrillators that have

been approved, or cleared for marketing, by the Food and Drug

Administration;

‘‘(2) provide basic life training in automated external

defibrillator usage through nationally recognized courses;

‘‘(3) provide information to community members about the

public access defibrillation demonstration project to be funded

with the grant;

45

‘‘(4) provide information to the local emergency medical

services system regarding the placement of automated external

defibrillators in the unique settings; and ‘‘(5) further develop strategies to improve access to automated external defibrillators in public places.

‘‘(c) APPLICATION.— ‘‘(1) IN GENERAL.—To be eligible to receive a grant under

subsection (a), a political subdivision of a State, Indian tribe,

or tribal organization shall prepare and submit an application

to the Secretary at such time, in such manner, and containing

such information as the Secretary may reasonably require. ‘‘(2) CONTENTS.—An application submitted under paragraph (1) may— ‘‘(A) describe the innovative, comprehensive, community-based public access defibrillation demonstration

project to be funded with the grant; ‘‘(B) explain how such public access defibrillation demonstration project represents innovation in providing public

access to automated external defibrillation; and ‘‘(C) provide for the collection of data regarding the effectiveness of the demonstration project to be funded with

the grant in— ‘‘(i) providing emergency cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims in the setting served by the demonstration project; and ‘‘(ii) affecting the cardiac arrest survival rate in

the setting served by the demonstration project. ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized

to be appropriated to carry out this section $5,000,000 for each of

fiscal years 2002 through 2006. Not more than 10 percent of

amounts received under a grant awarded under this section may be

used for administrative expenses.’’.

TITLE II—ENHANCING CONTROLS ON

DANGEROUS BIOLOGICAL AGENTS

AND TOXINS

Subtitle A—Department of Health and

Human Services

SEC. 201. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.

(a) BIOLOGICAL AGENTS PROVISIONS OF THE ANTITERRORISM

AND EFFECTIVE DEATH PENALTY ACT OF 1996; CODIFICATION IN THE

PUBLIC HEALTH SERVICE ACT, WITH AMENDMENTS.—Subpart 1 of

part F of title III of the Public Health Service Act (42 U.S.C. 262

et seq.) is amended by inserting after section 351 the following:

‘‘SEC. 351A. ENHANCED CONTROL OF DANGEROUS BIOLOGICAL

AGENTS AND TOXINS.

‘‘(a) REGULATORY CONTROL OF CERTAIN BIOLOGICAL AGENTS

AND TOXINS.—

‘‘(1) LIST OF BIOLOGICAL AGENTS AND TOXINS.—

46

‘‘(A) IN GENERAL.—The Secretary shall by regulation

establish and maintain a list of each biological agent and

each toxin that has the potential to pose a severe threat to

public health and safety. ‘‘(B) CRITERIA.—In determining whether to include an

agent or toxin on the list under subparagraph (A), the Secretary shall— ‘‘(i) consider— ‘‘(I) the effect on human health of exposure to

the agent or toxin; ‘‘(II) the degree of contagiousness of the agent

or toxin and the methods by which the agent or

toxin is transferred to humans; ‘‘(III) the availability and effectiveness of

pharmacotherapies and immunizations to treat

and prevent any illness resulting from infection by

the agent or toxin; and ‘‘(IV) any other criteria, including the needs of

children and other vulnerable populations, that

the Secretary considers appropriate; and

‘‘(ii) consult with appropriate Federal departments

and agencies and with scientific experts representing

appropriate professional groups, including groups with

pediatric expertise. ‘‘(2) BIENNIAL REVIEW.—The Secretary shall review and republish the list under paragraph (1) biennially, or more often

as needed, and shall by regulation revise the list as necessary

in accordance with such paragraph.

‘‘(b) REGULATION OF TRANSFERS OF LISTED AGENTS AND TOX- INS.—The Secretary shall by regulation provide for— ‘‘(1) the establishment and enforcement of safety procedures

for the transfer of listed agents and toxins, including measures

to ensure—

‘‘(A) proper training and appropriate skills to handle

such agents and toxins; and

‘‘(B) proper laboratory facilities to contain and dispose

of such agents and toxins;

‘‘(2) the establishment and enforcement of safeguard and security measures to prevent access to such agents and toxins for

use in domestic or international terrorism or for any other

criminal purpose;

‘‘(3) the establishment of procedures to protect the public

safety in the event of a transfer or potential transfer of such an

agent or toxin in violation of the safety procedures established

under paragraph (1) or the safeguard and security measures established under paragraph (2); and

‘‘(4) appropriate availability of biological agents and toxins

for research, education, and other legitimate purposes.

‘‘(c) POSSESSION AND USE OF LISTED AGENTS AND TOXINS.— The Secretary shall by regulation provide for the establishment and

enforcement of standards and procedures governing the possession

and use of listed agents and toxins, including the provisions described in paragraphs (1) through (4) of subsection (b), in order to

protect the public health and safety. ‘‘(d) REGISTRATION; IDENTIFICATION; DATABASE.—

47

‘‘(1) REGISTRATION.—Regulations under subsections (b) and

(c) shall require registration with the Secretary of the possession, use, and transfer of listed agents and toxins, and shall include provisions to ensure that persons seeking to register under

such regulations have a lawful purpose to possess, use, or transfer such agents and toxins, including provisions in accordance

with subsection (e)(6). ‘‘(2) IDENTIFICATION; DATABASE.—Regulations under subsections (b) and (c) shall require that registration include (if

available to the person registering) information regarding the

characterization of listed agents and toxins to facilitate their

identification, including their source. The Secretary shall maintain a national database that includes the names and locations

of registered persons, the listed agents and toxins such persons

are possessing, using, or transferring, and information regarding the characterization of such agents and toxins.

‘‘(e) SAFEGUARD AND SECURITY REQUIREMENTS FOR REG- ISTERED PERSONS.— ‘‘(1) IN GENERAL.—Regulations under subsections (b) and

(c) shall include appropriate safeguard and security requirements for persons possessing, using, or transferring a listed

agent or toxin commensurate with the risk such agent or toxin

poses to public health and safety (including the risk of use in

domestic or international terrorism). The Secretary shall establish such requirements in consultation with the Attorney General, and shall ensure compliance with such requirements as

part of the registration system under such regulations. ‘‘(2) LIMITING ACCESS TO LISTED AGENTS AND TOXINS.—Requirements under paragraph (1) shall include provisions to ensure that registered persons— ‘‘(A) provide access to listed agents and toxins to only

those individuals whom the registered person involved determines have a legitimate need to handle or use such

agents and toxins;

‘‘(B) submit the names and other identifying information for such individuals to the Secretary and the Attorney

General, promptly after first determining that the individuals need access under subparagraph (A), and periodically

thereafter while the individuals have such access, not less

frequently than once every five years;

‘‘(C) deny access to such agents and toxins by individuals whom the Attorney General has identified as restricted

persons; and

‘‘(D) limit or deny access to such agents and toxins by

individuals whom the Attorney General has identified as

within any category under paragraph (3)(B)(ii), if limiting

or denying such access by the individuals involved is determined appropriate by the Secretary, in consultation with

the Attorney General.

‘‘(3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY

GENERAL.—

‘‘(A) IN GENERAL.—Upon the receipt of names and other

identifying information under paragraph (2)(B), the Attorney General shall, for the sole purpose of identifying whether the individuals involved are within any of the categories

48

specified in subparagraph (B), promptly use criminal, immigration, national security, and other electronic databases

that are available to the Federal Government and are appropriate for such purpose. ‘‘(B) CERTAIN INDIVIDUALS.—For purposes of subparagraph (A), the categories specified in this subparagraph regarding an individual are that— ‘‘(i) the individual is a restricted person; or

‘‘(ii) the individual is reasonably suspected by any

Federal law enforcement or intelligence agency of— ‘‘(I) committing a crime set forth in section

2332b(g)(5) of title 18, United States Code; ‘‘(II) knowing involvement with an organization that engages in domestic or international terrorism (as defined in section 2331 of such title 18)

or with any other organization that engages in intentional crimes of violence; or ‘‘(III) being an agent of a foreign power (as defined in section 1801 of title 50, United States

Code). ‘‘(C) NOTIFICATION BY ATTORNEY GENERAL REGARDING

SUBMITTED NAMES.—After the receipt of a name and other

identifying information under paragraph (2)(B), the Attorney General shall promptly notify the Secretary whether the

individual is within any of the categories specified in subparagraph (B).

‘‘(4) NOTIFICATIONS BY SECRETARY.—The Secretary, after

receiving notice under paragraph (3) regarding an individual,

shall promptly notify the registered person involved of whether

the individual is granted or denied access under paragraph (2).

If the individual is denied such access, the Secretary shall

promptly notify the individual of the denial. ‘‘(5) EXPEDITED REVIEW.—Regulations under subsections (b)

and (c) shall provide for a procedure through which, upon request to the Secretary by a registered person who submits

names and other identifying information under paragraph

(2)(B) and who demonstrates good cause, the Secretary may, as

determined appropriate by the Secretary—

‘‘(A) request the Attorney General to expedite the process of identification under paragraph (3)(A) and notification of the Secretary under paragraph (3)(C); and

‘‘(B) expedite the notification of the registered person by

the Secretary under paragraph (4).

‘‘(6) PROCESS REGARDING PERSONS SEEKING TO REGISTER.—

‘‘(A) INDIVIDUALS.—Regulations under subsections (b)

and (c) shall provide that an individual who seeks to register under either of such subsections is subject to the same

processes described in paragraphs (2) through (4) as apply

to names and other identifying information submitted to

the Attorney General under paragraph (2)(B). Paragraph

(5) does not apply for purposes of this subparagraph. ‘‘(B) OTHER PERSONS.—Regulations under subsections

(b) and (c) shall provide that, in determining whether to

deny or revoke registration by a person other than an individual, the Secretary shall submit the name of such person

49

to the Attorney General, who shall use criminal, immigration, national security, and other electronic databases

available to the Federal Government, as appropriate for the

purpose of promptly notifying the Secretary whether the

person, or, where relevant, the individual who owns or controls such person, is a restricted person or is reasonably

suspected by any Federal law enforcement or intelligence

agency of being within any category specified in paragraph

(3)(B)(ii) (as applied to persons, including individuals).

Such regulations shall provide that a person who seeks to

register under either of such subsections is subject to the

same processes described in paragraphs (2) and (4) as

apply to names and other identifying information submitted to the Attorney General under paragraph (2)(B).

Paragraph (5) does not apply for purposes of this subparagraph. The Secretary may exempt Federal, State, or local

governmental agencies from the requirements of this subparagraph.

‘‘(7) REVIEW.— ‘‘(A) ADMINISTRATIVE REVIEW.— ‘‘(i) IN GENERAL.—Regulations under subsections

(b) and (c) shall provide for an opportunity for a review

by the Secretary— ‘‘(I) when requested by the individual involved,

of a determination under paragraph (2) to deny

the individual access to listed agents and toxins;

and ‘‘(II) when requested by the person involved, of

a determination under paragraph (6) to deny or revoke registration for such person.

‘‘(ii) EX PARTE REVIEW.—During a review under

clause (i), the Secretary may consider information relevant to the review ex parte to the extent that disclosure of the information could compromise national security or an investigation by any law enforcement

agency.

‘‘(iii) FINAL AGENCY ACTION.—The decision of the

Secretary in a review under clause (i) constitutes final

agency action for purposes of section 702 of title 5,

United States Code.

‘‘(B) CERTAIN PROCEDURES.—

‘‘(i) SUBMISSION OF EX PARTE MATERIALS IN JUDICIAL PROCEEDINGS.—When reviewing a decision of the

Secretary under subparagraph (A), and upon request

made ex parte and in writing by the United States, a

court, upon a sufficient showing, may review and consider ex parte documents containing information the

disclosure of which could compromise national security

or an investigation by any law enforcement agency. If

the court determines that portions of the documents

considered ex parte should be disclosed to the person

involved to allow a response, the court shall authorize

the United States to delete from such documents specified items of information the disclosure of which could

compromise national security or an investigation by

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any law enforcement agency, or to substitute a summary of the information to which the person may respond. Any order by the court authorizing the disclosure of information that the United States believes

could compromise national security or an investigation

by any law enforcement agency shall be subject to the

processes set forth in subparagraphs (A) and (B)(i) of

section 2339B(f)(5) of title 18, United States Code (relating to interlocutory appeal and expedited consideration). ‘‘(ii) DISCLOSURE OF INFORMATION.—In a review

under subparagraph (A), and in any judical proceeding

conducted pursuant to such review, neither the Secretary nor the Attorney General may be required to disclose to the public any information that under subsection (h) shall not be disclosed under section 552 of

title 5, United States Code. ‘‘(8) NOTIFICATIONS REGARDING THEFT OR LOSS OF

AGENTS.—Requirements under paragraph (1) shall include the

prompt notification of the Secretary, and appropriate Federal,

State, and local law enforcement agencies, of the theft or loss

of listed agents and toxins. ‘‘(9) TECHNICAL ASSISTANCE FOR REGISTERED PERSONS.— The Secretary, in consultation with the Attorney General, may

provide technical assistance to registered persons to improve security of the facilities of such persons.

‘‘(f) INSPECTIONS.—The Secretary shall have the authority to inspect persons subject to regulations under subsection (b) or (c) to ensure their compliance with such regulations, including prohibitions

on restricted persons and other provisions of subsection (e). ‘‘(g) EXEMPTIONS.— ‘‘(1) CLINICAL OR DIAGNOSTIC LABORATORIES.—Regulations

under subsections (b) and (c) shall exempt clinical or diagnostic

laboratories and other persons who possess, use, or transfer listed agents or toxins that are contained in specimens presented

for diagnosis, verification, or proficiency testing, provided

that— ‘‘(A) the identification of such agents or toxins is reported to the Secretary, and when required under Federal,

State, or local law, to other appropriate authorities; and ‘‘(B) such agents or toxins are transferred or destroyed

in a manner set forth by the Secretary by regulation.

‘‘(2) PRODUCTS.—

‘‘(A) IN GENERAL.—Regulations under subsections (b)

and (c) shall exempt products that are, bear, or contain listed agents or toxins and are cleared, approved, licensed, or

registered under any of the Acts specified in subparagraph

(B), unless the Secretary by order determines that applying

additional regulation under subsection (b) or (c) to a specific product is necessary to protect public health and safety. ‘‘(B) RELEVANT LAWS.—For purposes of subparagraph

(A), the Acts specified in this subparagraph are the following: ‘‘(i) The Federal Food, Drug, and Cosmetic Act.

51

‘‘(ii) Section 351 of this Act.

‘‘(iii) The Act commonly known as the VirusSerum-Toxin Act (the eighth paragraph under the

heading ‘Bureau of Animal Industry’ in the Act of

March 4, 1913; 21 U.S.C. 151–159). ‘‘(iv) The Federal Insecticide, Fungicide, and

Rodenticide Act.

‘‘(C) INVESTIGATIONAL USE.— ‘‘(i) IN GENERAL.—The Secretary may exempt an

investigational product that is, bears, or contains a

listed agent or toxin from the applicability of provisions of regulations under subsection (b) or (c) when

such product is being used in an investigation authorized under any Federal Act and the Secretary determines that applying additional regulation under subsection (b) or (c) to such product is not necessary to

protect public health and safety. ‘‘(ii) CERTAIN PROCESSES.—Regulations under subsections (b) and (c) shall set forth the procedures for

applying for an exemption under clause (i). In the case

of investigational products authorized under any of the

Acts specified in subparagraph (B), the Secretary shall

make a determination regarding a request for an exemption not later than 14 days after the first date on

which both of the following conditions have been met

by the person requesting the exemption: ‘‘(I) The person has submitted to the Secretary

an application for the exemption meeting the requirements established by the Secretary. ‘‘(II) The person has notified the Secretary that

the investigation has been authorized under such

an Act. ‘‘(3) PUBLIC HEALTH EMERGENCIES.—The Secretary may

temporarily exempt a person from the applicability of the requirements of this section, in whole or in part, if the Secretary

determines that such exemption is necessary to provide for the

timely participation of the person in a response to a domestic

or foreign public health emergency (whether determined under

section 319(a) or otherwise) that involves a listed agent or toxin.

With respect to the emergency involved, such exemption for a

person may not exceed 30 days, except that the Secretary, after

review of whether such exemption remains necessary, may provide one extension of an additional 30 days.

‘‘(4) AGRICULTURAL EMERGENCIES.—Upon request of the

Secretary of Agriculture, after the granting by such Secretary of

an exemption under section 212(g)(1)(D) of the Agricultural Bioterrorism Protection Act of 2002 pursuant to a finding that

there is an agricultural emergency, the Secretary of Health and

Human Services may temporarily exempt a person from the applicability of the requirements of this section, in whole or in

part, to provide for the timely participation of the person in a

response to the agricultural emergency. With respect to the

emergency involved, the exemption under this paragraph for a

person may not exceed 30 days, except that upon request of the

Secretary of Agriculture, the Secretary of Health and Human

52

Services may, after review of whether such exemption remains

necessary, provide one extension of an additional 30 days.

‘‘(h) DISCLOSURE OF INFORMATION.— ‘‘(1) NONDISCLOSURE OF CERTAIN INFORMATION.—No Federal agency specified in paragraph (2) shall disclose under section 552 of title 5, United States Code, any of the following: ‘‘(A) Any registration or transfer documentation submitted under subsections (b) and (c) for the possession, use,

or transfer of a listed agent or toxin; or information derived

therefrom to the extent that it identifies the listed agent or

toxin possessed, used, or transferred by a specific registered

person or discloses the identity or location of a specific registered person. ‘‘(B) The national database developed pursuant to subsection (d), or any other compilation of the registration or

transfer information submitted under subsections (b) and

(c) to the extent that such compilation discloses site-specific

registration or transfer information. ‘‘(C) Any portion of a record that discloses the site-specific or transfer-specific safeguard and security measures

used by a registered person to prevent unauthorized access

to listed agents and toxins. ‘‘(D) Any notification of a release of a listed agent or

toxin submitted under subsections (b) and (c), or any notification of theft or loss submitted under such subsections. ‘‘(E) Any portion of an evaluation or report of an inspection of a specific registered person conducted under

subsection (f) that identifies the listed agent or toxin possessed by a specific registered person or that discloses the

identity or location of a specific registered person if the

agency determines that public disclosure of the information

would endanger public health or safety.

‘‘(2) COVERED AGENCIES.—For purposes of paragraph (1)

only, the Federal agencies specified in this paragraph are the

following:

‘‘(A) The Department of Health and Human Services,

the Department of Justice, the Department of Agriculture,

and the Department of Transportation.

‘‘(B) Any Federal agency to which information specified

in paragraph (1) is transferred by any agency specified in

subparagraph (A) of this paragraph.

‘‘(C) Any Federal agency that is a registered person, or

has a sub-agency component that is a registered person.

‘‘(D) Any Federal agency that awards grants or enters

into contracts or cooperative agreements involving listed

agents and toxins to or with a registered person, and to

which information specified in paragraph (1) is transferred

by any such registered person.

‘‘(3) OTHER EXEMPTIONS.—This subsection may not be construed as altering the application of any exemptions to public

disclosure under section 552 of title 5, United States Code, except as to subsection 552(b)(3) of such title, to any of the information specified in paragraph (1). ‘‘(4) RULE OF CONSTRUCTION.—Except as specifically provided in paragraph (1), this subsection may not be construed as

53

altering the authority of any Federal agency to withhold under

section 552 of title 5, United States Code, or the obligation of

any Federal agency to disclose under section 552 of title 5,

United States Code, any information, including information relating to—

‘‘(A) listed agents and toxins, or individuals seeking access to such agents and toxins; ‘‘(B) registered persons, or persons seeking to register

their possession, use, or transfer of such agents and toxins; ‘‘(C) general safeguard and security policies and requirements under regulations under subsections (b) and (c);

or ‘‘(D) summary or statistical information concerning

registrations, registrants, denials or revocations of registrations, listed agents and toxins, inspection evaluations and

reports, or individuals seeking access to such agents and

toxins.

‘‘(5) DISCLOSURES TO CONGRESS; OTHER DISCLOSURES.— This subsection may not be construed as providing any

authority—

‘‘(A) to withhold information from the Congress or any

committee or subcommittee thereof; or ‘‘(B) to withhold information from any person under

any other Federal law or treaty. ‘‘(i) CIVIL MONEY PENALTY.— ‘‘(1) IN GENERAL.—In addition to any other penalties that

may apply under law, any person who violates any provision of

regulations under subsection (b) or (c) shall be subject to the

United States for a civil money penalty in an amount not exceeding $250,000 in the case of an individual and $500,000 in

the case of any other person. ‘‘(2) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions of section 1128A of the Social Security Act (other than

subsections (a), (b), (h), and (i), the first sentence of subsection

(c), and paragraphs (1) and (2) of subsection (f)) shall apply to

a civil money penalty under paragraph (1) in the same manner

as such provisions apply to a penalty or proceeding under section 1128A(a) of such Act. The Secretary may delegate authority

under this subsection in the same manner as provided in section 1128A(j)(2) of the Social Security Act, and such authority

shall include all powers as contained in section 6 of the Inspector General Act of 1978 (5 U.S.C. App.).

‘‘(j) NOTIFICATION IN EVENT OF RELEASE.—Regulations under

subsections (b) and (c) shall require the prompt notification of the

Secretary by a registered person whenever a release, meeting criteria

established by the Secretary, of a listed agent or toxin has occurred

outside of the biocontainment area of a facility of the registered person. Upon receipt of such notification and a finding by the Secretary

that the release poses a threat to public health or safety, the Secretary shall take appropriate action to notify relevant State and

local public health authorities, other relevant Federal authorities,

and, if necessary, other appropriate persons (including the public).

If the released listed agent or toxin is an overlap agent or toxin (as

defined in subsection (l)), the Secretary shall promptly notify the

Secretary of Agriculture upon notification by the registered person.

54

‘‘(k) REPORTS.—The Secretary shall report to the Congress annually on the number and nature of notifications received under

subsection (e)(8) (relating to theft or loss) and subsection (j) (relating

to releases). ‘‘(l) DEFINITIONS.—For purposes of this section: ‘‘(1) The terms ‘biological agent’ and ‘toxin’ have the meanings given such terms in section 178 of title 18, United States

Code.‘‘(2) The term ‘listed agents and toxins’ means biological

agents and toxins listed pursuant to subsection (a)(1). ‘‘(3) The term ‘listed agents or toxins’ means biological

agents or toxins listed pursuant to subsection (a)(1). ‘‘(4) The term ‘overlap agents and toxins’ means biological

agents and toxins that— ‘‘(A) are listed pursuant to subsection (a)(1); and

‘‘(B) are listed pursuant to section 212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002.

‘‘(5) The term ‘overlap agent or toxin’ means a biological

agent or toxin that— ‘‘(A) is listed pursuant to subsection (a)(1); and

‘‘(B) is listed pursuant to section 212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002.

‘‘(6) The term ‘person’ includes Federal, State, and local

governmental entities. ‘‘(7) The term ‘registered person’ means a person registered

under regulations under subsection (b) or (c). ‘‘(8) The term ‘restricted person’ has the meaning given such

term in section 175b of title 18, United States Code.

‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, there are authorized to be appropriated

such sums as may be necessary for each of the fiscal years 2002

through 2007.’’. (b) REPORT TO CONGRESS.—Not later than one year after the

date of the enactment of this Act, the Secretary of Health and

Human Services, after consultation with other appropriate Federal

agencies, shall submit to the Congress a report that—

(1) describes the extent to which there has been compliance

by governmental and private entities with applicable regulations under section 351A of the Public Health Service Act (as

added by subsection (a) of this section), including the extent of

compliance before the date of the enactment of this Act, and including the extent of compliance with regulations promulgated

after such date of enactment;

(2) describes the actions to date and future plans of the Secretary for updating the list of biological agents and toxins

under such section 351A;

(3) describes the actions to date and future plans of the Secretary for determining compliance with regulations under such

section 351A and for taking appropriate enforcement actions;

(4) evaluates the impact of such section 351A on research

on biological agents and toxins listed pursuant to such section;

and

(5) provides any recommendations of the Secretary for administrative or legislative initiatives regarding such section

351A.

55

SEC. 202. IMPLEMENTATION BY DEPARTMENT OF HEALTH AND HUMAN

SERVICES.

(a) DATE CERTAIN FOR NOTICE OF POSSESSION.—Not later than

90 days after the date of the enactment of this Act, all persons (unless exempt under subsection (g) of section 351A of the Public

Health Service Act, as added by section 201 of this Act) in possession of biological agents or toxins listed under such section 351A of

the Public Health Service Act shall notify the Secretary of Health

and Human Services of such possession. Not later than 30 days

after such date of enactment, the Secretary shall provide written

guidance on how such notice is to be provided to the Secretary.

(b) DATE CERTAIN FOR PROMULGATION; EFFECTIVE DATE REGARDING CRIMINAL AND CIVIL PENALTIES.—Not later than 180 days

after the date of the enactment of this Act, the Secretary of Health

and Human Services shall promulgate an interim final rule for carrying out section 351A of the Public Health Service Act, subject to

subsection (c). Such interim final rule shall take effect 60 days after

the date on which such rule is promulgated, including for purposes

of—

(1) section 175b(c) of title 18, United States Code (relating

to criminal penalties), as added by section 231(a)(5) of this Act;

and

(2) section 351A(i) of the Public Health Service Act (relating

to civil penalties).

(c) TRANSITIONAL PROVISION REGARDING CURRENT RESEARCH

AND EDUCATION.—The interim final rule under subsection (b) shall

include time frames for the applicability of the rule that minimize

disruption of research or educational projects that involve biological

agents and toxins listed pursuant to section 351A(a)(1) of the Public

Health Service Act and that were underway as of the effective date

of such rule.

SEC. 203. EFFECTIVE DATES.

(a) IN GENERAL.—Regulations promulgated by the Secretary of

Health and Human Services under section 511 of the Antiterrorism

and Effective Death Penalty Act of 1996 are deemed to have been

promulgated under section 351A of the Public Health Service Act,

as added by section 201 of this Act. Such regulations, including the

list under subsection (d)(1) of such section 511, that were in effect

on the day before the date of the enactment of this Act remain in

effect until modified by the Secretary in accordance with such section 351A and with section 202 of this Act.

(b) EFFECTIVE DATE REGARDING DISCLOSURE OF INFORMATION.—Subsection (h) of section 351A of the Public Health Service

Act, as added by section 201 of this Act, is deemed to have taken

effect on the effective date of the Antiterrorism and Effective Death

Penalty Act of 1996.

SEC. 204. CONFORMING AMENDMENT.

Subsections (d), (e), (f), and (g) of section 511 of the

Antiterrorism and Effective Death Penalty Act of 1996 (42 U.S.C.

262 note) are repealed.

56

Subtitle B—Department of Agriculture

SEC. 211. SHORT TITLE.

This subtitle may be cited as the ‘‘Agricultural Bioterrorism

Protection Act of 2002’’.

SEC. 212. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.

(a) REGULATORY CONTROL OF CERTAIN BIOLOGICAL AGENTS

AND TOXINS.—

(1) LIST OF BIOLOGICAL AGENTS AND TOXINS.—

(A) IN GENERAL.—The Secretary of Agriculture shall by

regulation establish and maintain a list of each biological

agent and each toxin that the Secretary determines has the

potential to pose a severe threat to animal or plant health,

or to animal or plant products.

(B) CRITERIA.—In determining whether to include an

agent or toxin on the list under subparagraph (A), the Secretary shall—

(i) consider—

(I) the effect of exposure to the agent or toxin

on animal or plant health, and on the production

and marketability of animal or plant products;

(II) the pathogenicity of the agent or the toxicity of the toxin and the methods by which the

agent or toxin is transferred to animals or plants;

(III) the availability and effectiveness of

pharmacotherapies and prophylaxis to treat and

prevent any illness caused by the agent or toxin;

and

(IV) any other criteria that the Secretary considers appropriate to protect animal or plant

health, or animal or plant products; and

(ii) consult with appropriate Federal departments

and agencies and with scientific experts representing

appropriate professional groups.

(2) BIENNIAL REVIEW.—The Secretary shall review and republish the list under paragraph (1) biennially, or more often

as needed, and shall by regulation revise the list as necessary

in accordance with such paragraph.

(b) REGULATION OF TRANSFERS OF LISTED AGENTS AND TOX- INS.—The Secretary shall by regulation provide for— (1) the establishment and enforcement of safety procedures

for the transfer of listed agents and toxins, including measures

to ensure—

(A) proper training and appropriate skills to handle

such agents and toxins; and

(B) proper laboratory facilities to contain and dispose

of such agents and toxins;

(2) the establishment and enforcement of safeguard and security measures to prevent access to such agents and toxins for

use in domestic or international terrorism or for any other

criminal purpose;

(3) the establishment of procedures to protect animal and

plant health, and animal and plant products, in the event of a

57

transfer or potential transfer of such an agent or toxin in violation of the safety procedures established under paragraph (1) or

the safeguard and security measures established under paragraph (2); and

(4) appropriate availability of biological agents and toxins

for research, education, and other legitimate purposes.

(c) POSSESSION AND USE OF LISTED AGENTS AND TOXINS.—The

Secretary shall by regulation provide for the establishment and enforcement of standards and procedures governing the possession

and use of listed agents and toxins, including the provisions described in paragraphs (1) through (4) of subsection (b), in order to

protect animal and plant health, and animal and plant products.

(d) REGISTRATION; IDENTIFICATION; DATABASE.—

(1) REGISTRATION.—Regulations under subsections (b) and

(c) shall require registration with the Secretary of the possession, use, and transfer of listed agents and toxins, and shall include provisions to ensure that persons seeking to register under

such regulations have a lawful purpose to possess, use, or transfer such agents and toxins, including provisions in accordance

with subsection (e)(6).

(2) IDENTIFICATION; DATABASE.—Regulations under subsections (b) and (c) shall require that registration include (if

available to the person registering) information regarding the

characterization of listed agents and toxins to facilitate their

identification, including their source. The Secretary shall maintain a national database that includes the names and locations

of registered persons, the listed agents and toxins such persons

are possessing, using, or transferring, and information regarding the characterization of such agents and toxins.

(e) SAFEGUARD AND SECURITY REQUIREMENTS FOR REGISTERED

PERSONS.—

(1) IN GENERAL.—Regulations under subsections (b) and (c)

shall include appropriate safeguard and security requirements

for persons possessing, using, or transferring a listed agent or

toxin commensurate with the risk such agent or toxin poses to

animal and plant health, and animal and plant products (including the risk of use in domestic or international terrorism).

The Secretary shall establish such requirements in consultation

with the Attorney General, and shall ensure compliance with

such requirements as part of the registration system under such

regulations.

(2) LIMITING ACCESS TO LISTED AGENTS AND TOXINS.—Requirements under paragraph (1) shall include provisions to ensure that registered persons—

(A) provide access to listed agents and toxins to only

those individuals whom the registered person involved determines have a legitimate need to handle or use such

agents and toxins;

(B) submit the names and other identifying information for such individuals to the Secretary and the Attorney

General, promptly after first determining that the individuals need access under subparagraph (A), and periodically

thereafter while the individuals have such access, not less

frequently than once every five years; and

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(C)(i) in the case of listed agents and toxins that are

not overlap agents and toxins (as defined in subsection

(g)(1)(A)(ii)), limit or deny access to such agents and toxins

by individuals whom the Attorney General has identified as

within any category under paragraph (3)(B), if limiting or

denying such access by the individuals involved is determined appropriate by the Secretary, in consultation with

the Attorney General; and

(ii) in the case of listed agents and toxins that are overlap agents— (I) deny access to such agents and toxins by individuals whom the Attorney General has identified as within any category referred to in paragraph (3)(B)(i); and

(II) limit or deny access to such agents and

toxins by individuals whom the Attorney General

has identified as within any category under paragraph (3)(B)(ii), if limiting or denying such access

by the individuals involved is determined appropriate by the Secretary, in consultation with the

Attorney General.

(3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY

GENERAL.—

(A) IN GENERAL.—Upon the receipt of names and other

identifying information under paragraph (2)(B), the Attorney General shall, for the sole purpose of identifying whether the individuals involved are within any of the categories

specified in subparagraph (B), promptly use criminal, immigration, national security, and other electronic databases

that are available to the Federal Government and are appropriate for such purpose.

(B) CERTAIN INDIVIDUALS.—For purposes of subparagraph (A), the categories specified in this subparagraph regarding an individual are that— (i) the individual is within any of the categories

described in section 175b(d)(1) of title 18, United States

Code (relating to restricted persons); or

(ii) the individual is reasonably suspected by any

Federal law enforcement or intelligence agency of— (I) committing a crime set forth in section

2332b(g)(5) of title 18, United States Code;

(II) knowing involvement with an organization

that engages in domestic or international terrorism

(as defined in section 2331 of such title 18) or with

any other organization that engages in intentional

crimes of violence; or

(III) being an agent of a foreign power (as defined in section 1801 of title 50, United States

Code).

(C) NOTIFICATION BY ATTORNEY GENERAL REGARDING

SUBMITTED NAMES.—After the receipt of a name and other

identifying information under paragraph (2)(B), the Attorney General shall promptly notify the Secretary whether the

individual is within any of the categories specified in subparagraph (B).

59

(4) NOTIFICATIONS BY SECRETARY.—The Secretary, after receiving notice under paragraph (3) regarding an individual,

shall promptly notify the registered person involved of whether

the individual is granted or denied access under paragraph (2).

If the individual is denied such access, the Secretary shall

promptly notify the individual of the denial.

(5) EXPEDITED REVIEW.—Regulations under subsections (b)

and (c) shall provide for a procedure through which, upon request to the Secretary by a registered person who submits

names and other identifying information under paragraph

(2)(B) and who demonstrates good cause, the Secretary may, as

determined appropriate by the Secretary— (A) request the Attorney General to expedite the process

of identification under paragraph (3)(A) and notification of

the Secretary under paragraph (3)(C); and

(B) expedite the notification of the registered person by

the Secretary under paragraph (4).

(6) PROCESS REGARDING PERSONS SEEKING TO REGISTER.— (A) INDIVIDUALS.—Regulations under subsections (b)

and (c) shall provide that an individual who seeks to register under either of such subsections is subject to the same

processes described in paragraphs (2) through (4) as apply

to names and other identifying information submitted to

the Attorney General under paragraph (2)(B). Paragraph

(5) does not apply for purposes of this subparagraph.

(B) OTHER PERSONS.—Regulations under subsections

(b) and (c) shall provide that, in determining whether to

deny or revoke registration by a person other than an individual, the Secretary shall submit the name of such person

to the Attorney General, who shall use criminal, immigration, national security, and other electronic databases

available to the Federal Government, as appropriate for the

purpose of promptly notifying the Secretary whether the

person, or, where relevant, the individual who owns or controls such person, is within any of the categories described

in section 175b(d)(1) of title 18, United States Code (relating to restricted persons), or is reasonably suspected by any

Federal law enforcement or intelligence agency of being

within any category specified in paragraph (3)(B)(ii) (as applied to persons, including individuals). Such regulations

shall provide that a person who seeks to register under either of such subsections is subject to the same processes described in paragraphs (2) and (4) as apply to names and

other identifying information submitted to the Attorney

General under paragraph (2)(B). Paragraph (5) does not

apply for purposes of this subparagraph. The Secretary

may exempt Federal, State, or local governmental agencies

from the requirements of this subparagraph.

(7) REVIEW.— (A) ADMINISTRATIVE REVIEW.— (i) IN GENERAL.—Regulations under subsections (b)

and (c) shall provide for an opportunity for a review by

the Secretary—

(I) when requested by the individual involved,

of a determination under paragraph (2) to deny

60

the individual access to listed agents and toxins;

and

(II) when requested by the person involved, of

a determination under paragraph (6) to deny or revoke registration for such person.

(ii) EX PARTE REVIEW.—During a review under

clause (i), the Secretary may consider information relevant to the review ex parte to the extent that disclosure of the information could compromise national security or an investigation by any law enforcement

agency.

(iii) FINAL AGENCY ACTION.—The decision of the

Secretary in a review under clause (i) constitutes final

agency action for purposes of section 702 of title 5,

United States Code.

(B) CERTAIN PROCEDURES.—

(i) SUBMISSION OF EX PARTE MATERIALS IN JUDICIAL PROCEEDINGS.—When reviewing a decision of the

Secretary under subparagraph (A), and upon request

made ex parte and in writing by the United States, a

court, upon a sufficient showing, may review and consider ex parte documents containing information the

disclosure of which could compromise national security

or an investigation by any law enforcement agency. If

the court determines that portions of the documents

considered ex parte should be disclosed to the person

involved to allow a response, the court shall authorize

the United States to delete from such documents specified items of information the disclosure of which could

compromise national security or an investigation by

any law enforcement agency, or to substitute a summary of the information to which the person may respond. Any order by the court authorizing the disclosure of information that the United States believes

could compromise national security or an investigation

by any law enforcement agency shall be subject to the

processes set forth in subparagraphs (A) and (B)(i) of

section 2339B(f)(5) of title 18, United States Code (relating to interlocutory appeal and expedited consideration).

(ii) DISCLOSURE OF INFORMATION.—In a review

under subparagraph (A), and in any judical proceeding

conducted pursuant to such review, neither the Secretary nor the Attorney General may be required to disclose to the public any information that under subsection (h) shall not be disclosed under section 552 of

title 5, United States Code.

(8) NOTIFICATIONS REGARDING THEFT OR LOSS OF

AGENTS.—Requirements under paragraph (1) shall include the

prompt notification of the Secretary, and appropriate Federal,

State, and local law enforcement agencies, of the theft or loss

of listed agents and toxins.

(9) TECHNICAL ASSISTANCE FOR REGISTERED PERSONS.—

The Secretary, in consultation with the Attorney General, may

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provide technical assistance to registered persons to improve security of the facilities of such persons.

(f) INSPECTIONS.—The Secretary shall have the authority to inspect persons subject to regulations under subsection (b) or (c) to ensure their compliance with such regulations, including prohibitions

on restricted persons and other provisions of subsection (e).

(g) EXEMPTIONS.— (1) OVERLAP AGENTS AND TOXINS.— (A) IN GENERAL.— (i) LIMITATION.—In the case of overlap agents and

toxins, exemptions from the applicability of provisions

of regulations under subsection (b) or (c) may be granted only to the extent provided in this paragraph.

(ii) DEFINITIONS.—For purposes of this section:

(I) The term ‘‘overlap agents and toxins’’ means biological agents and toxins that— (aa) are listed pursuant to subsection

(a)(1); and

(bb) are listed pursuant to section

315A(a)(1) of the Public Health Service Act.

(II) The term ‘‘overlap agent or toxin’’ means a

biological agent or toxin that— (aa) is listed pursuant to subsection (a)(1);

and

(bb) is listed pursuant to section

315A(a)(1) of the Public Health Service Act.

(B) CLINICAL OR DIAGNOSTIC LABORATORIES.—Regulations under subsections (b) and (c) shall exempt clinical or

diagnostic laboratories and other persons who possess, use,

or transfer overlap agents or toxins that are contained in

specimens presented for diagnosis, verification, or proficiency testing, provided that— (i) the identification of such agents or toxins is reported to the Secretary, and when required under Federal, State, or local law, to other appropriate authorities; and

(ii) such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation.

(C) PRODUCTS.—

(i) IN GENERAL.—Regulations under subsections (b)

and (c) shall exempt products that are, bear, or contain

overlap agents or toxins and are cleared, approved, licensed, or registered under any of the Acts specified in

clause (ii), unless the Secretary by order determines

that applying additional regulation under subsection

(b) or (c) to a specific product is necessary to protect

animal or plant health, or animal or plant products.

(ii) RELEVANT LAWS.—For purposes of clause (i),

the Acts specified in this clause are the following:

(I) The Federal Food, Drug, and Cosmetic Act.

(II) Section 351 of the Public Health Service

Act.

(III) The Act commonly known as the VirusSerum-Toxin Act (the eighth paragraph under the

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heading ‘Bureau of Animal Industry’ in the Act of

March 4, 1913; 21 U.S.C. 151-159).

(IV) The Federal Insecticide, Fungicide, and

Rodenticide Act.

(iii) INVESTIGATIONAL USE.— (I) IN GENERAL.—The Secretary may exempt

an investigational product that is, bears, or contains an overlap agent or toxin from the applicability of provisions of regulations under subsection

(b) or (c) when such product is being used in an

investigation authorized under any Federal Act

and the Secretary determines that applying additional regulation under subsection (b) or (c) to such

product is not necessary to protect animal and

plant health, and animal and plant products.

(II) CERTAIN PROCESSES.—Regulations under

subsections (b) and (c) shall set forth the procedures for applying for an exemption under subclause (I). In the case of investigational products

authorized under any of the Acts specified in

clause (ii), the Secretary shall make a determination regarding a request for an exemption not later

than 14 days after the first date on which both of

the following conditions have been met by the person requesting the exemption:

(aa) The person has submitted to the Secretary an application for the exemption meeting the requirements established by the Secretary.

(bb) The person has notified the Secretary

that the investigation has been authorized

under such an Act.

(D) AGRICULTURAL EMERGENCIES.— The Secretary may

temporarily exempt a person from the applicability of the

requirements of this section with respect to an overlap

agent or toxin, in whole or in part, if the Secretary determines that such exemption is necessary to provide for the

timely participation of the person in a response to a domestic or foreign agricultural emergency that involves such an

agent or toxin. With respect to the emergency involved, the

exemption under this subparagraph for a person may not

exceed 30 days, except that the Secretary, after review of

whether such exemption remains necessary, may provide

one extension of an additional 30 days.

(E) PUBLIC HEALTH EMERGENCIES.—Upon request of

the Secretary of Health and Human Services, after the

granting by such Secretary of an exemption under

351A(g)(3) of the Public Health Service Act pursuant to a

finding that there is a public health emergency, the Secretary of Agriculture may temporarily exempt a person from

the applicability of the requirements of this section with respect to an overlap agent or toxin, in whole or in part, to

provide for the timely participation of the person in a response to the public health emergency. With respect to the

emergency involved, such exemption for a person may not

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exceed 30 days, except that upon request of the Secretary of

Health and Human Services, the Secretary of Agriculture

may, after review of whether such exemption remains necessary, provide one extension of an additional 30 days.

(2) GENERAL AUTHORITY FOR EXEMPTIONS NOT INVOLVING

OVERLAP AGENTS OR TOXINS.—In the case of listed agents or toxins that are not overlap agents or toxins, the Secretary may

grant exemptions from the applicability of provisions of regulations under subsection (b) or (c) if the Secretary determines that

such exemptions are consistent with protecting animal and

plant health, and animal and plant products.

(h) DISCLOSURE OF INFORMATION.—

(1) NONDISCLOSURE OF CERTAIN INFORMATION.—No Federal agency specified in paragraph (2) shall disclose under section 552 of title 5, United States Code, any of the following:

(A) Any registration or transfer documentation submitted under subsections (b) and (c), or permits issued

prior to the date of the enactment of this Act, for the possession, use or transfer of a listed agent or toxin; or information derived therefrom to the extent that it identifies the

listed agent or toxin possessed, used or transferred by a

specific person or discloses the identity or location of a specific person.

(B) The national database developed pursuant to subsection (d), or any other compilation of the registration or

transfer information submitted under subsections (b) and

(c) to the extent that such compilation discloses site-specific

registration or transfer information.

(C) Any portion of a record that discloses the site-specific or transfer-specific safeguard and security measures

used by a registered person to prevent unauthorized access

to listed agents and toxins.

(D) Any notification of a release of a listed agent or

toxin submitted under subsections (b) and (c), or any notification of theft or loss submitted under such subsections.

(E) Any portion of an evaluation or report of an inspection of a specific registered person conducted under subsection (f) that identifies the listed agent or toxin possessed

by a specific registered person or that discloses the identity

or location of a specific registered person if the agency determines that public disclosure of the information would

endanger animal or plant health, or animal or plant products.

(2) COVERED AGENCIES.—For purposes of paragraph (1)

only, the Federal agencies specified in this paragraph are the

following:

(A) The Department of Health and Human Services,

the Department of Justice, the Department of Agriculture,

and the Department of Transportation.

(B) Any Federal agency to which information specified

in paragraph (1) is transferred by any agency specified in

subparagraph (A) of this paragraph.

(C) Any Federal agency that is a registered person, or

has a sub-agency component that is a registered person.

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(D) Any Federal agency that awards grants or enters

into contracts or cooperative agreements involving listed

agents and toxins to or with a registered person, and to

which information specified in paragraph (1) is transferred

by any such registered person.

(3) OTHER EXEMPTIONS.—This subsection may not be construed as altering the application of any exemptions to public

disclosure under section 552 of title 5, United States Code, except as to subsection 552(b)(3) of such title, to any of the information specified in paragraph (1).

(4) RULE OF CONSTRUCTION.—Except as specifically provided in paragraph (1), this subsection may not be construed as

altering the authority of any Federal agency to withhold under

section 552 of title 5, United States Code, or the obligation of

any Federal agency to disclose under section 552 of title 5,

United States Code, any information, including information relating to—

(A) listed agents and toxins, or individuals seeking access to such agents and toxins;

(B) registered persons, or persons seeking to register

their possession, use, or transfer of such agents and toxins;

(C) general safeguard and security policies and requirements under regulations under subsections (b) and (c);

or

(D) summary or statistical information concerning registrations, registrants, denials or revocations of registrations, listed agents and toxins, inspection evaluations and

reports, or individuals seeking access to such agents and

toxins.

(5) DISCLOSURES TO CONGRESS; OTHER DISCLOSURES.—This

subsection may not be construed as providing any authority— (A) to withhold information from the Congress or any

committee or subcommittee thereof; or

(B) to withhold information from any person under any

other Federal law or treaty.

(i) CIVIL MONEY PENALTY.— (1) IN GENERAL.—In addition to any other penalties that

may apply under law, any person who violates any provision of

regulations under subsection (b) or (c) shall be subject to the

United States for a civil money penalty in an amount not exceeding $250,000 in the case of an individual and $500,000 in

the case of any other person.

(2) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions

of sections 423 and 425(2) of the Plant Protection Act (7 U.S.C.

7733 and 7735(2) shall apply to a civil money penalty or activity under paragraph (1) in the same manner as such provisions

apply to a penalty or activity under the Plant Protection Act.

(j) NOTIFICATION IN EVENT OF RELEASE.—Regulations under

subsections (b) and (c) shall require the prompt notification of the

Secretary by a registered person whenever a release, meeting criteria

established by the Secretary, of a listed agent or toxin has occurred

outside of the biocontainment area of a facility of the registered person. Upon receipt of such notification and a finding by the Secretary

that the release poses a threat to animal or plant health, or animal

or plant products, the Secretary shall take appropriate action to noVerDate 11-MAY-2000 07:55 May 23, 2002 Jkt 099006 PO 00000 Frm 00068 Fmt 6659 Sfmt 6603 E:\HR\OC\HR481.XXX pfrm09 PsN: HR481
65

tify relevant Federal, State, and local authorities, and, if necessary,

other appropriate persons (including the public). If the released listed agent or toxin is an overlap agent or toxin, the Secretary shall

promptly notify the Secretary of Health and Human Services upon

notification by the registered person.

(k) REPORTS.—The Secretary shall report to the Congress annually on the number and nature of notifications received under subsection (e)(8) (relating to theft or loss) and subsection (j) (relating to

releases).

(l) DEFINITIONS.—For purposes of this section:

(1) The terms ‘‘biological agent’’ and ‘‘toxin’’ have the meanings given such terms in section 178 of title 18, United States

Code.

(2) The term ‘‘listed agents and toxins’’ means biological

agents and toxins listed pursuant to subsection (a)(1).

(3) The term ‘‘listed agents or toxins’’ means biological

agents or toxins listed pursuant to subsection (a)(1).

(4) The terms ‘‘overlap agents and toxins’’ and ‘‘overlap

agent or toxin’’ have the meaning given such terms in subsection (g)(1)(A)(ii).

(5) The term ‘‘person’’ includes Federal, State, and local

governmental entities.

(6) The term ‘‘registered person’’ means a person registered

under regulations under subsection (b) or (c).

(7) The term ‘‘‘Secretary’’ means the Secretary of Agriculture.

(m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, there are authorized to be appropriated

such sums as may be necessary for each of the fiscal years 2002

through 2007, in addition to other funds that may be available.

SEC. 213. IMPLEMENTATION BY DEPARTMENT OF AGRICULTURE.

(a) DATE CERTAIN FOR PROMULGATION OF LIST.—Not later than

60 days after the date of the enactment of this Act, the Secretary of

Agriculture (referred to in this section as the ‘‘Secretary’’) shall promulgate an interim final rule that establishes the initial list under

section 212(a)(1). In promulgating such rule, the Secretary shall

provide written guidance on the manner in which the notice required in subsection (b) is to be provided to the Secretary.

(b) DATE CERTAIN FOR NOTICE OF POSSESSION.—Not later than

60 days after the date on which the Secretary promulgates the interim final rule under subsection (a), all persons (unless exempt

under section 212(g)) in possession of biological agents or toxins included on the list referred to in subsection (a) shall notify the Secretary of such possession.

(c) DATE CERTAIN FOR PROMULGATION; EFFECTIVE DATE REGARDING CRIMINAL AND CIVIL PENALTIES.—Not later than 180 days

after the date of the enactment of this Act, the Secretary shall promulgate an interim final rule for carrying out section 212, other

than for the list referred to in subsection (a) of this section (but such

rule may incorporate by reference provisions promulgated pursuant

to subsection (a)). Such interim final rule shall take effect 60 days

after the date on which such rule is promulgated, including for purposes of—

66

(1) section 175b(c) of title 18, United States Code (relating

to criminal penalties), as added by section 231(a)(5) of this Act;

and

(2) section 212(i) of this Act (relating to civil penalties).

(d) TRANSITIONAL PROVISION REGARDING CURRENT RESEARCH

AND EDUCATION.—The interim final rule under subsection (c) shall

include time frames for the applicability of the rule that minimize

disruption of research or educational projects that involve biological

agents and toxins listed pursuant to section 212(a)(1) and that were

underway as of the effective date of such rule.

Subtitle C—Interagency Coordination

Regarding Overlap Agents and Toxins

SEC. 221. INTERAGENCY COORDINATION.

(a) IN GENERAL.— (1) COORDINATION.—The Secretary of Agriculture and the

Secretary of Health and Human Services shall in accordance

with this section coordinate activities regarding overlap agents

and toxins.

(2) OVERLAP AGENTS AND TOXINS; OTHER TERMS.—For purposes of this section:

(A) The term ‘‘overlap agent or toxin’’ means a biological agent or toxin that— (i) is listed pursuant to section 315A(a)(1) of the

Public Health Service Act, as added by section 201 of

this Act; and

(ii) is listed pursuant to section 212(a)(1) of this

Act.

(B) The term ‘‘section 351A program’’ means the program under section 351A of the Public Health Service Act.

(C) The term ‘‘section 212 program’’ means the program

under section 212 of this Act.

(b) CERTAIN MATTERS.—In carrying out the section 351A program and the section 212 program, the Secretary of Health and

Human Services and the Secretary of Agriculture shall, to the greatest extent practicable, coordinate activities to achieve the following

purposes:

(1) To minimize any conflicts between the regulations

issued under, and activities carried out under, such programs.

(2) To minimize the administrative burden on persons subject to regulation under both of such programs.

(3) To ensure the appropriate availability of biological

agents and toxins for legitimate biomedical, agricultural or veterinary research, education, or other such purposes.

(4) To ensure that registration information for overlap

agents and toxins under the section 351A and section 212 programs is contained in both the national database under the section 351A program and the national database under the section

212 program.

(c) MEMORANDUM OF UNDERSTANDING.—

(1) IN GENERAL.—Promptly after the date of the enactment

of this Act, the Secretary of Agriculture and the Secretary of

Health and Human Services shall enter into a memorandum of

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understanding regarding overlap agents and toxins that is in

accordance with paragraphs (2) through (4) and contains such

additional provisions as the Secretary of Agriculture and the

Secretary of Health and Human Services determine to be appropriate.

(2) SINGLE REGISTRATION SYSTEM REGARDING REGISTERED

PERSONS.—The memorandum of understanding under paragraph (1) shall provide for the development and implementation

of a single system of registration for persons who possess, use,

or transfer overlap agents or toxins and are required to register

under both the section 351A program and the section 212 program. For purposes of such system, the memorandum shall provide for the development and implementation of the following:

(A) A single registration form through which the person submitting the form provides all information that is required for registration under the section 351A program and

all information that is required for registration under the

section 212 program.

(B) A procedure through which a person may choose to

submit the single registration form to the agency administering the section 351A program (in the manner provided

under such program), or to the agency administering the

section 212 program (in the manner provided under such

program).

(C) A procedure through which a copy of a single registration form received pursuant to subparagraph (B) by

the agency administering one of such programs is promptly

provided to the agency administering the other program.

(D) A procedure through which the agency receiving the

single registration form under one of such programs obtains the concurrence of the agency administering the other

program that the requirements for registration under the

other program have been met.

(E) A procedure through which—

(i) the agency receiving the single registration form

under one of such programs informs the agency administering the other program whether the receiving agency has denied the registration; and

(ii) each of such agencies ensures that registrations

are entered into the national database of registered persons that is maintained by each such agency.

(3) PROCESS OF IDENTIFICATION.—With respect to the process of identification under the section 351A program and the

section 212 program for names and other identifying information submitted to the Attorney General (relating to certain categories of individuals and entities), the memorandum of understanding under paragraph (1) shall provide for the development

and implementation of the following:

(A) A procedure through which a person who is required to submit information pursuant to such process

makes (in addition to the submission to the Attorney General) a submission, at the option of the person, to either the

agency administering the section 351A program or the

agency administering the section 212 program, but not

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both, which submission satisfies the requirement of submission for both of such programs.

(B) A procedure for the sharing by both of such agencies of information received from the Attorney General by

one of such agencies pursuant to the submission under subparagraph (A).

(C) A procedure through which the agencies administering such programs concur in determinations that access to overlap agents and toxins will be granted.

(4) COORDINATION OF INSPECTIONS AND ENFORCEMENT.—

The memorandum of understanding under paragraph (1) shall

provide for the development and implementation of procedures

under which Federal personnel under the section 351A program

and the section 212 program may share responsibilities for inspections and enforcement activities under such programs regarding overlap agents and toxins. Activities carried out under

such procedures by one of such programs on behalf of the other

may be carried out with or without reimbursement by the agency that administers the other program.

(5) DATE CERTAIN FOR IMPLEMENTATION.—The memorandum of understanding under paragraph (1) shall be implemented not later than 180 days after the date of the enactment

of this Act. Until the single system of registration under paragraph (2) is implemented, persons who possess, use, or transfer

overlap agents or toxins shall register under both the section

351A program and the section 212 program.

(d) JOINT REGULATIONS.—Not later than 18 months after the

date on which the single system of registration under subsection

(c)(2) is implemented, the Secretary of Health and Human Services

and the Secretary of Agriculture shall jointly issue regulations for

the possession, use, and transfer of overlap agents and toxins that

meet the requirements of both the section 351A program and the section 212 program.

Subtitle D—Criminal Penalties Regarding

Certain Biological Agents and Toxins

SEC. 231. CRIMINAL PENALTIES.

(a) IN GENERAL.—Section 175b of title 18, United States Code,

as added by section 817 of Public Law 107–56, is amended—

(1) by striking ‘‘(a)’’ and inserting ‘‘(a)(1)’’;

(2) by transferring subsection (c) from the current placement of the subsection and inserting the subsection before subsection (b);

(3) by striking ‘‘(c)’’ and inserting ‘‘(2);

(4) by redesignating subsection (b) as subsection (d); and

(5) by inserting before subsection (d) (as so redesignated)

the following subsections:

‘‘(b) TRANSFER TO UNREGISTERED PERSON.—

‘‘(1) SELECT AGENTS.—Whoever transfers a select agent to a

person who the transferor knows or has reasonable cause to believe is not registered as required by regulations under subsection (b) or (c) of section 351A of the Public Health Service

69

Act shall be fined under this title, or imprisoned for not more

than 5 years, or both. ‘‘(2) CERTAIN OTHER BIOLOGICAL AGENTS AND TOXINS.— Whoever transfers a biological agent or toxin listed pursuant to

section 212(a)(1) of the Agricultural Bioterrorism Protection Act

of 2002 to a person who the transferor knows or has reasonable

cause to believe is not registered as required by regulations

under subsection (b) or (c) of section 212 of such Act shall be

fined under this title, or imprisoned for not more than 5 years,

or both.

‘‘(c) UNREGISTERED FOR POSSESSION.— ‘‘(1) SELECT AGENTS.—Whoever knowingly possesses a biological agent or toxin where such agent or toxin is a select agent

for which such person has not obtained a registration required

by regulations under section 351A(c) of the Public Health Service Act shall be fined under this title, or imprisoned for not

more than 5 years, or both. ‘‘(2) CERTAIN OTHER BIOLOGICAL AGENTS AND TOXINS.— Whoever knowingly possesses a biological agent or toxin where

such agent or toxin is a biological agent or toxin listed pursuant

to section 212(a)(1) of the Agricultural Bioterrorism Protection

Act of 2002 for which such person has not obtained a registration required by regulations under section 212(c) of such Act

shall be fined under this title, or imprisoned for not more than

5 years, or both.’’. (b) CONFORMING AMENDMENTS.—Chapter 10 of title 18, United

States Code, is amended— (1) in section 175b (as added by section 817 of Public Law

107–56 and amended by subsection (a) of this section)— (A) in subsection (d)(1), by striking ‘‘The term’’ and all

that follows through ‘‘does not include’’ and inserting the

following: ‘‘The term ‘select agent’ means a biological agent

or toxin to which subsection (a) applies. Such term (including for purposes of subsection (a)) does not include’’; and

(B) in the heading for the section, by striking ‘‘Possession by restricted persons’’ and inserting ‘‘Select

agents; certain other agents’’; and

(2) in the chapter analysis, in the item relating to section

175b, by striking ‘‘Possession by restricted persons.’’ and inserting ‘‘Select agents; certain other agents.’’.

(c) TECHNICAL CORRECTIONS.—Chapter 10 of title 18, United

States Code, as amended by section 817 of Public Law 107–56 and

subsections (a) and (b) of this section, is amended—

(1) in section 175(c), by striking ‘‘protective’’ and all that

follows and inserting ‘‘protective, bona fide research, or other

peaceful purposes.’’;

(2) in section 175b—

(A) in subsection (a)(1), by striking ‘‘described in subsection (b)’’ and all that follows and inserting the following: ‘‘shall ship or transport in or affecting interstate or foreign

commerce, or possess in or affecting interstate or foreign

commerce, any biological agent or toxin, or receive any biological agent or toxin that has been shipped or transported

in interstate or foreign commerce, if the biological agent or

toxin is listed as a select agent in Appendix A of part 72

70

of title 42, Code of Federal Regulations, pursuant to section

351A of the Public Health Service Act, and is not exempted

under subsection (h) of section 72.6, or Appendix A of part

72, of title 42, Code of Federal Regulations.’’; and

(B) in subsection (d)(3), by striking ‘‘section 1010(a)(3)’’

and inserting ‘‘section 101(a)(3)’’;

(3) in section 176(a)(1)(A), by striking ‘‘exists by reason of’’

and inserting ‘‘pertains to’’; and

(4) in section 178—

(A) in paragraph (1), by striking ‘‘means any micro-organism’’ and all that follows through ‘‘product, capable of’’

and inserting the following: ‘‘means any microorganism (including, but not limited to, bacteria, viruses, fungi,

rickettsiae or protozoa), or infectious substance, or any naturally occurring, bioengineered or synthesized component of

any such microorganism or infectious substance, capable

of’’;

(B) in paragraph (2), by striking ‘‘means the toxic’’ and

all that follows through ‘‘including—’’ and inserting the following: ‘‘means the toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, rickettsiae or protozoa), or infectious

substances, or a recombinant or synthesized molecule,

whatever their origin and method of production, and includes—’’; and

(C) in paragraph (4), by striking ‘‘recombinant molecule,’’ and all that follows through ‘‘biotechnology,’’ and inserting ‘‘recombinant or synthesized molecule,’’.

(d) ADDITIONAL TECHNICAL CORRECTION.—Section 2332a of

title 18, United States Code, is amended—

(1) in subsection (a), in the matter preceding paragraph (1),

by striking ‘‘section 229F)’’ and all that follows through ‘‘section

178)—’’ and inserting ‘‘section 229F)—’’; and

(2) in subsection (c)(2)(C), by striking ‘‘a disease organism’’

and inserting ‘‘a biological agent, toxin, or vector (as those

terms are defined in section 178 of this title)’’.

TITLE III—PROTECTING SAFETY AND

SECURITY OF FOOD AND DRUG SUPPLY

Subtitle A—Protection of Food Supply

SEC. 301. FOOD SAFETY AND SECURITY STRATEGY.

(a) IN GENERAL.—The President’s Council on Food Safety (as

established by Executive Order 13100) shall, in consultation with

the Secretary of Transportation, the Secretary of the Treasury, other

relevant Federal agencies, the food industry, consumer and producer

groups, scientific organizations, and the States, develop a crisis

communications and education strategy with respect to bioterrorist

threats to the food supply. Such strategy shall address threat assessments; technologies and procedures for securing food processing and

manufacturing facilities and modes of transportation; response and

notification procedures; and risk communications to the public.

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(b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

implementing the strategy developed under subsection (a), there are

authorized to be appropriated $750,000 for fiscal year 2002, and

such sums as may be necessary for each subsequent fiscal year.

SEC. 302. PROTECTION AGAINST ADULTERATION OF FOOD.

(a) INCREASING INSPECTIONS FOR DETECTION OF ADULTERATION

OF FOOD.—Section 801 of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 381) is amended by adding at the end the following subsection:

‘‘(h)(1) The Secretary shall give high priority to increasing the

number of inspections under this section for the purpose of enabling

the Secretary to inspect food offered for import at ports of entry into

the United States, with the greatest priority given to inspections to

detect the intentional adulteration of food.’’.

(b) IMPROVEMENTS TO INFORMATION MANAGEMENT SYSTEMS.—

Section 801(h) of the Federal Food, Drug, and Cosmetic Act, as

added by subsection (a) of this section, is amended by adding at the

end the following paragraph:

‘‘(2) The Secretary shall give high priority to making necessary

improvements to the information management systems of the Food

and Drug Administration that contain information related to foods

imported or offered for import into the United States for purposes

of improving the ability of the Secretary to allocate resources, detect

the intentional adulteration of food, and facilitate the importation

of food that is in compliance with this Act.’’.

(c) LINKAGES WITH APPROPRIATE PUBLIC ENTITIES.—Section

801(h) of the Federal Food, Drug, and Cosmetic Act, as amended by

subsection (b) of this section, is amended by adding at the end the

following paragraph:

‘‘(3) The Secretary shall improve linkages with other regulatory

agencies of the Federal Government that share responsibility for

food safety, and shall with respect to such safety improve linkages

with the States and Indian tribes (as defined in section 4(e) of the

Indian Self-Determination and Education Assistance Act (25 U.S.C.

450b(e))).’’.

(d) TESTING FOR RAPID DETECTION OF ADULTERATION OF

FOOD.—Section 801 of the Federal Food, Drug, and Cosmetic Act,

as amended by subsection (a) of this section, is amended by adding

at the end the following:

‘‘(i)(1) For use in inspections of food under this section, the Secretary shall provide for research on the development of tests and

sampling methodologies—

‘‘(A) whose purpose is to test food in order to rapidly detect

the adulteration of the food, with the greatest priority given to

detect the intentional adulteration of food; and

‘‘(B) whose results offer significant improvements over the

available technology in terms of accuracy, timing, or costs.

‘‘(2) In providing for research under paragraph (1), the Secretary shall give priority to conducting research on the development

of tests that are suitable for inspections of food at ports of entry into

the United States.

‘‘(3) In providing for research under paragraph (1), the Secretary shall as appropriate coordinate with the Director of the Centers for Disease Control and Prevention, the Director of the National

72

Institutes of Health, the Administrator of the Environmental Protection Agency, and the Secretary of Agriculture.

‘‘(4) The Secretary shall annually submit to the Committee on

Energy and Commerce of the House of Representatives, and the

Committee on Health, Education, Labor, and Pensions of the Senate, a report describing the progress made in research under paragraph (1), including progress regarding paragraph (2).’’.

(e) ASSESSMENT OF THREAT OF INTENTIONAL ADULTERATION OF

FOOD.—The Secretary of Health and Human Services, acting

through the Commissioner of Food and Drugs, shall ensure that,

not later than six months after the date of the enactment of this

Act—

(1) the assessment that (as of such date of enactment) is

being conducted on the threat of the intentional adulteration of

food is completed; and

(2) a report describing the findings of the assessment is

submitted to the Committee on Energy and Commerce of the

House of Representatives and to the Committee on Health, Education, Labor, and Pensions of the Senate.

(f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section and the amendments made by this section,

there are authorized to be appropriated $100,000,000 for fiscal year

2002, and such sums as may be necessary for each of the fiscal

years 2003 through 2006, in addition to other authorizations of appropriations that are available for such purpose.

SEC. 303. ADMINISTRATIVE DETENTION.

(a) EXPANDED AUTHORITY.—Section 304 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 334) is amended by adding at

the end the following subsection:

‘‘(h) ADMINISTRATIVE DETENTION OF FOODS.—

‘‘(1) DETENTION AUTHORITY.—

‘‘(A) IN GENERAL.—An officer or qualified employee of

the Food and Drug Administration may order the detention, in accordance with this subsection, of any article of

food that is found during an inspection, examination, or investigation under this Act conducted by such officer or

qualified employee, if the officer or qualified employee has

credible evidence or information indicating that such article presents a threat of serious adverse health consequences

or death to humans or animals.

‘‘(B) SECRETARY’S APPROVAL.—An article of food may

be ordered detained under subparagraph (A) only if the

Secretary or an official designated by the Secretary approves the order. An official may not be so designated unless the official is the director of the district under this Act

in which the article involved is located, or is an official senior to such director.

‘‘(2) PERIOD OF DETENTION.—An article of food may be detained under paragraph (1) for a reasonable period, not to exceed 20 days, unless a greater period, not to exceed 30 days, is

necessary, to enable the Secretary to institute an action under

subsection (a) or section 302. The Secretary shall by regulation

provide for procedures for instituting such action on an expedited basis with respect to perishable foods.

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‘‘(3) SECURITY OF DETAINED ARTICLE.—An order under

paragraph (1) with respect to an article of food may require

that such article be labeled or marked as detained, and shall

require that the article be removed to a secure facility, as appropriate. An article subject to such an order shall not be transferred by any person from the place at which the article is ordered detained, or from the place to which the article is so removed, as the case may be, until released by the Secretary or

until the expiration of the detention period applicable under

such order, whichever occurs first. This subsection may not be

construed as authorizing the delivery of the article pursuant to

the execution of a bond while the article is subject to the order,

and section 801(b) does not authorize the delivery of the article

pursuant to the execution of a bond while the article is subject

to the order.

‘‘(4) APPEAL OF DETENTION ORDER.—

‘‘(A) IN GENERAL.—With respect to an article of food ordered detained under paragraph (1), any person who would

be entitled to be a claimant for such article if the article

were seized under subsection (a) may appeal the order to

the Secretary. Within five days after such an appeal is

filed, the Secretary, after providing opportunity for an informal hearing, shall confirm or terminate the order involved, and such confirmation by the Secretary shall be

considered a final agency action for purposes of section 702

of title 5, United States Code. If during such five-day period the Secretary fails to provide such an opportunity, or

to confirm or terminate such order, the order is deemed to

be terminated.

‘‘(B) EFFECT OF INSTITUTING COURT ACTION.—The process under subparagraph (A) for the appeal of an order

under paragraph (1) terminates if the Secretary institutes

an action under subsection (a) or section 302 regarding the

article of food involved.’’.

(b) PROHIBITED ACT.—Section 301 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end

the following:

‘‘(bb) The transfer of an article of food in violation of an order

under section 304(h), or the removal or alteration of any mark or

label required by the order to identify the article as detained.’’.

(c) TEMPORARY HOLDS AT PORTS OF ENTRY.—Section 801 of the

Federal Food, Drug, and Cosmetic Act, as amended by section

302(d)of this Act, is amended by adding at the end the following:

‘‘(j)(1) If an officer or qualified employee of the Food and Drug

Administration has credible evidence or information indicating that

an article of food presents a threat of serious adverse health consequences or death to humans or animals, and such officer or qualified employee is unable to inspect, examine, or investigate such article upon the article being offered for import at a port of entry into

the United States, the officer or qualified employee shall request the

Secretary of Treasury to hold the food at the port of entry for a reasonable period of time, not to exceed 24 hours, for the purpose of enabling the Secretary to inspect, examine, or investigate the article as

appropriate.

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‘‘(2) The Secretary shall request the Secretary of Treasury to remove an article held pursuant to paragraph (1) to a secure facility,

as appropriate. During the period of time that such article is so

held, the article shall not be transferred by any person from the port

of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.

Subsection (b) does not authorize the delivery of the article pursuant

to the execution of a bond while the article is so held.

‘‘(3) An officer or qualified employee of the Food and Drug Administration may make a request under paragraph (1) only if the

Secretary or an official designated by the Secretary approves the request. An official may not be so designated unless the official is the

director of the district under this Act in which the article involved

is located, or is an official senior to such director.

‘‘(4) With respect to an article of food for which a request under

paragraph (1) is made, the Secretary, promptly after the request is

made, shall notify the State in which the port of entry involved is

located that the request has been made, and as applicable, that such

article is being held under this subsection.’’.

SEC. 304. DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT VIOLATIONS.

(a) DEBARMENT AUTHORITY.—

(1) PERMISSIVE DEBARMENT.—Section 306(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(1)) is

amended—

(A) in subparagraph (A), by striking ‘‘or’’ after the

comma at the end;

(B) in subparagraph (B), by striking the period at the

end and inserting ‘‘, or’’; and

(C) by adding at the end the following subparagraph:

‘‘(C) a person from importing an article of food or offering such an article for import into the United States.’’;

(2) AMENDMENT REGARDING DEBARMENT GROUNDS.—Section 306(b)) of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 335a(b)) is amended—

(A) in paragraph (2), in the matter preceding subparagraph (A), by inserting ‘‘subparagraph (A) or (B) of’’ before

‘‘paragraph (1)’’;

(B) by redesignating paragraph (3) as paragraph (4);

and

(C) by inserting after paragraph (2) the following paragraph:

‘‘(3) PERSONS SUBJECT TO PERMISSIVE DEBARMENT; FOOD

IMPORTATION.—A person is subject to debarment under paragraph (1)(C) if—

‘‘(A) the person has been convicted of a felony for conduct relating to the importation into the United States of

any food; or

‘‘(B) the person has engaged in a pattern of importing

or offering for import adulterated food that presents a

threat of serious adverse health consequences or death to

humans or animals.’’.

(b) CONFORMING AMENDMENTS.—Section 306 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is amended—

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(1) in subsection (a), in the heading for the subsection, by

striking ‘‘MANDATORY DEBARMENT.—’’ and inserting ‘‘MANDATORY DEBARMENT; CERTAIN DRUG APPLICATIONS.—’’;

(2) in subsection (b)—

(A) in the heading for the subsection, by striking ‘‘PERMISSIVE DEBARMENT.—’’ and inserting ‘‘PERMISSIVE DEBARMENT; CERTAIN DRUG APPLICATIONS; FOOD IMPORTS.—’’;

and

(B) in paragraph (2), in the heading for the paragraph,

by striking ‘‘PERMISSIVE DEBARMENT.—’’ and inserting

‘‘PERMISSIVE DEBARMENT; CERTAIN DRUG APPLICATIONS.—’’;

(3) in subsection (c)(2)(A)(iii), by striking ‘‘subsection (b)(2)’’

and inserting ‘‘paragraph (2) or (3) of subsection (b)’’;

(4) in subsection (d)(3)—

(A) in subparagraph (A)(i), by striking ‘‘or (b)(2)(A)’’

and inserting ‘‘ or paragraph (2)(A) or (3) of subsection (b)’’;

(B) in subparagraph (A)(ii)(II), by inserting ‘‘in applicable cases,’’ before ‘‘sufficient audits’’;

(C) in subparagraph (B), in each of clauses (i) and (ii),

by inserting ‘‘or subsection (b)(3)’’ after ‘‘subsection

(b)(2)(B)’’; and

(D) in subparagraph (B)(ii), by inserting before the period the following: ‘‘or the food importation process, as the

case may be’’.

(c) EFFECTIVE DATES.—Section 306(l)(2) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 335a(l)(2)) is amended—

(1) in the first sentence—

(A) by striking ‘‘and’’ after ‘‘subsection (b)(2),’’; and

(B) by inserting ‘‘, and subsection (b)(3)(A)’’ after ‘‘subsection (b)(2)(B)’’; and

(2) in the second sentence, by inserting ‘‘, subsection

(b)(3)(B),’’ after ‘‘subsection (b)(2)(B)’’.

(d) PROHIBITED ACT.—Section 301 of the Federal Food, Drug,

and Cosmetic Act, as amended by section 303(b) of this Act, is

amended by adding at the end the following:

‘‘(cc) The importing or offering for import into the United States

of an article of food by, with the assistance of, or at the direction

of, a person debarred under section 306(b)(3).’’.

(e) IMPORTATION BY DEBARRED PERSONS.—Section 801 of the

Federal Food, Drug, and Cosmetic Act, as amended by section

303(c) of this Act, is amended by adding at the end the following

subsection:

‘‘(k)(1) If an article of food is being imported or offered for import into the United States, and the importer, owner, or consignee

of the article is a person who has been debarred under section

306(b)(3), such article shall be held at the port of entry for the article, and may not be delivered to such person. Subsection (b) does not

authorize the delivery of the article pursuant to the execution of a

bond while the article is so held. The article shall be removed to a

secure facility, as appropriate. During the period of time that such

article is so held, the article shall not be transferred by any person

from the port of entry into the United States for the article, or from

the secure facility to which the article has been removed, as the case

may be.

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‘‘(2) An article of food held under paragraph (1) may be delivered to a person who is not a debarred person under section

306(b)(3) if such person affirmatively establishes, at the expense of

the person, that the article complies with the requirements of this

Act, as determined by the Secretary.’’.

SEC. 305. REGISTRATION OF FOOD FACILITIES.

(a) IN GENERAL.—Chapter IV of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at the

end the following:

‘‘SEC. 415. REGISTRATION OF FOOD FACILITIES.

‘‘(a) REGISTRATION.—

‘‘(1) IN GENERAL.—The Secretary shall by regulation require that any facility engaged in manufacturing, processing,

packing, or holding food for consumption in the United States

be registered with the Secretary. To be registered—

‘‘(A) for a domestic facility, the owner, operator, or

agent in charge of the facility shall submit a registration

to the Secretary; and

‘‘(B) for a foreign facility, the owner, operator, or agent

in charge of the facility shall submit a registration to the

Secretary and shall include with the registration the name

of the United States agent for the facility.

‘‘(2) REGISTRATION.—An entity (referred to in this section as

the ‘registrant’) shall submit a registration under paragraph (1)

to the Secretary containing information necessary to notify the

Secretary of the name and address of each facility at which,

and all trade names under which, the registrant conducts business and, when determined necessary by the Secretary through

guidance, the general food category (as identified under section

170.3 of title 21, Code of Federal Regulations) of any food manufactured, processed, packed, or held at such facility. The registrant shall notify the Secretary in a timely manner of changes

to such information.

‘‘(3) PROCEDURE.—Upon receipt of a completed registration

described in paragraph (1), the Secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered facility.

‘‘(4) LIST.—The Secretary shall compile and maintain an

up-to-date list of facilities that are registered under this section.

Such list and any registration documents submitted pursuant

to this subsection shall not be subject to disclosure under section 552 of title 5, United States Code. Information derived

from such list or registration documents shall not be subject to

disclosure under section 552 of title 5, United States Code, to

the extent that it discloses the identity or location of a specific

registered person.

‘‘(b) FACILITY.—For purposes of this section:

‘‘(1) The term ‘facility’ includes any factory, warehouse, or

establishment (including a factory, warehouse, or establishment

of an importer) that manufactures, processes, packs, or holds

food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which

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ing vessels (except such vessels engaged in processing as defined

in section 123.3(k) of title 21, Code of Federal Regulations).

‘‘(2) The term ‘domestic facility’ means a facility located in

any of the States or Territories.

‘‘(3)(A) The term ‘foreign facility’ means a facility that manufacturers, processes, packs, or holds food, but only if food from

such facility is exported to the United States without further

processing or packaging outside the United States.

‘‘(B) A food may not be considered to have undergone further processing or packaging for purposes of subparagraph (A)

solely on the basis that labeling was added or that any similar

activity of a de minimis nature was carried out with respect to

the food.

‘‘(c) RULE OF CONSTRUCTION.—Nothing in this section shall be

construed to authorize the Secretary to require an application, review, or licensing process.’’.

(b) PROHIBITED ACTS.—Section 301 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 331), as amended by section 304(d) of

this Act, is amended by adding at the end the following:

‘‘(dd) The failure to register in accordance with section 415.’’.

(c) IMPORTATION; FAILURE TO REGISTER.—Section 801 of the

Federal Food, Drug, and Cosmetic Act, as amended by section

304(e) of this Act, is amended by adding at the end the following

subsection:

‘‘(l)(1) If an article of food is being imported or offered for import into the United States, and such article is from a foreign facility for which a registration has not been submitted to the Secretary

under section 415, such article shall be held at the port of entry for

the article, and may not be delivered to the importer, owner, or consignee of the article, until the foreign facility is so registered. Subsection (b) does not authorize the delivery of the article pursuant to

the execution of a bond while the article is so held. The article shall

be removed to a secure facility, as appropriate. During the period

of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States

for the article, or from the secure facility to which the article has

been removed, as the case may be.’’.

(d) ELECTRONIC FILING.—For the purpose of reducing paperwork and reporting burdens, the Secretary of Health and Human

Services may provide for, and encourage the use of, electronic methods of submitting to the Secretary registrations required pursuant

to this section. In providing for the electronic submission of such

registrations, the Secretary shall ensure adequate authentication

protocols are used to enable identification of the registrant and validation of the data as appropriate.

(e) RULEMAKING; EFFECTIVE DATE.—Not later than 18 months

after the date of the enactment of this Act, the Secretary of Health

and Human Services shall promulgate proposed and final regulations for the requirement of registration under section 415 of the

Federal Food, Drug, and Cosmetic Act (as added by subsection (a)

of this section). Such requirement of registration takes effect—

(1) upon the effective date of such final regulations; or

(2) upon the expiration of such 18-month period if the final

regulations have not been made effective as of the expiration of

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such period, subject to compliance with the final regulations

when the final regulations are made effective.

SEC. 306. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS.

(a) IN GENERAL.—Chapter IV of the Federal Food, Drug, and

Cosmetic Act, as amended by section 305 of this Act, is amended by

inserting before section 415 the following section:

‘‘SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.

‘‘(a) RECORDS INSPECTION.—If the Secretary has a reasonable

belief that an article of food is adulterated and presents a threat of

serious adverse health consequences or death to humans or animals,

each person (excluding farms and restaurants) who manufactures,

processes, packs, distributes, receives, holds, or imports such article

shall, at the request of an officer or employee duly designated by the

Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article

that are needed to assist the Secretary in determining whether the

food is adulterated and presents a threat of serious adverse health

consequences or death to humans or animals. The requirement

under the preceding sentence applies to all records relating to the

manufacture, processing, packing, distribution, receipt, holding, or

importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at

any location.

‘‘(b) REGULATIONS CONCERNING RECORDKEEPING.—The Secretary, in consultation and coordination, as appropriate, with other

Federal departments and agencies with responsibilities for regulating food safety, may by regulation establish requirements regarding the establishment and maintenance, for not longer than two

years, of records by persons (excluding farms and restaurants) who

manufacture, process, pack, transport, distribute, receive, hold, or

import food, which records are needed by the Secretary for inspection to allow the Secretary to identify the immediate previous

sources and the immediate subsequent recipients of food, including

its packaging, in order to address credible threats of serious adverse

health consequences or death to humans or animals. The Secretary

shall take into account the size of a business in promulgating regulations under this section.

‘‘(c) PROTECTION OF SENSITIVE INFORMATION.—The Secretary

shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any

trade secret or confidential information that is obtained by the Secretary pursuant to this section.

‘‘(d) LIMITATIONS.—This section shall not be construed—

‘‘(1) to limit the authority of the Secretary to inspect records

or to require establishment and maintenance of records under

any other provision of this Act;

‘‘(2) to authorize the Secretary to impose any requirements

with respect to a food to the extent that it is within the exclusive

jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry

Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg

Products Inspection Act (21 U.S.C. 1031 et seq);

79

‘‘(3) to have any legal effect on section 552 of title 5, United

States Code, or section 1905 of title 18, United States Code; or ‘‘(4) to extend to recipes for food, financial data, pricing

data, personnel data, research data, or sales data (other than

shipment data regarding sales).’’. (b) FACTORY INSPECTION.—Section 704(a) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended— (1) in paragraph (1), by inserting after the first sentence the

following new sentence: ‘‘In the case of any person (excluding

farms and restaurants) who manufactures, processes, packs,

transports, distributes, holds, or imports foods, the inspection

shall extend to all records and other information described in

section 414 when the Secretary has a reasonable belief that an

article of food is adulterated and presents a threat of serious

adverse health consequences or death to humans or animals,

subject to the limitations established in section 414(d).’’; and

(2) in paragraph (2), in the matter preceding subparagraph

(A), by striking ‘‘second sentence’’ and inserting ‘‘third sentence’’. (c) PROHIBITED ACT.—Section 301 of the Federal Food, Drug

and Cosmetic Act (21 U.S.C. 331) is amended— (1) in paragraph (e)— (A) by striking ‘‘by section 412, 504, or 703’’ and inserting ‘‘by section 412, 414, 504, 703, or 704(a)’’; and

(B) by striking ‘‘under section 412’’ and inserting ‘‘under section 412, 414(b)’’; and

(2) in paragraph (j), by inserting ‘‘414,’’ after ‘‘412,’’. (d) EXPEDITED RULEMAKING.—Not later than 18 months after

the date of the enactment of this Act, the Secretary shall promulgate

proposed and final regulations establishing recordkeeping requirements under subsection 414(b) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).

SEC. 307. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

(a) IN GENERAL.—Section 801 of the Federal Food, Drug, and

Cosmetic Act, as amended by section 305(c) of this Act, is amended

by adding at the end the following subsection: ‘‘(m)(1) In the case of an article of food that is being imported

or offered for import into the United States, the Secretary, after consultation with the Secretary of the Treasury, shall by regulation require, for the purpose of enabling such article to be inspected at

ports of entry into the United States, the submission to the Secretary

of a notice providing the identity of each of the following: The article; the manufacturer and shipper of the article; if known within the

specified period of time that notice is required to be provided, the

grower of the article; the country from which the article originates;

the country from which the article is shipped; and the anticipated

port of entry for the article. An article of food imported or offered

for import without submission of such notice in accordance with the

requirements under this paragraph shall be refused admission into

the United States. Nothing in this section may be construed as a

limitation on the port of entry for an article of food. ‘‘(2)(A) Regulations under paragraph (1) shall require that a notice under such paragraph be provided by a specified period of time

in advance of the time of the importation of the article of food involved or the offering of the food for import, which period shall be

no less than the minimum amount of time necessary for the SecVerDate 11-MAY-2000 07:55 May 23, 2002 Jkt 099006 PO 00000 Frm 00083 Fmt 6659 Sfmt 6603 E:\HR\OC\HR481.XXX pfrm09 PsN: HR481
80

retary to receive, review, and appropriately respond to such notification, but may not exceed five days. In determining the specified period of time required under this subparagraph, the Secretary may

consider, but is not limited to consideration of, the effect on commerce of such period of time, the locations of the various ports of

entry into the United States, the various modes of transportation,

the types of food imported into the United States, and any other

such consideration. Nothing in the preceding sentence may be construed as a limitation on the obligation of the Secretary to receive,

review, and appropriately respond to any notice under paragraph

(1). ‘‘(B)(i) If an article of food is being imported or offered for import into the United States and a notice under paragraph (1) is not

provided in advance in accordance with the requirements under

paragraph (1), such article shall be held at the port of entry for the

article, and may not be delivered to the importer, owner, or consignee of the article, until such notice is submitted to the Secretary,

and the Secretary examines the notice and determines that the notice is in accordance with the requirements under paragraph (1).

Subsection (b) does not authorize the delivery of the article pursuant

to the execution of a bond while the article is so held. The article

shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be

transferred by any person from the port of entry into the United

States for the article, or from the secure facility to which the article

has been removed, as the case may be. ‘‘(ii) In carrying out clause (i) with respect to an article of food,

the Secretary shall determine whether there is in the possession of

the Secretary any credible evidence or information indicating that

such article presents a threat of serious adverse health consequences

or death to humans or animals. ‘‘(3)(A) This subsection may not be construed as limiting the authority of the Secretary to obtain information under any other provision of this Act.

‘‘(B) This subsection may not be construed as authorizing the

Secretary to impose any requirements with respect to a food to the

extent that it is within the exclusive jurisdiction of the Secretary of

Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C.

601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et

seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq).’’.

(b) PROHIBITED ACT.—Section 301 of the Federal Food, Drug,

and Cosmetic Act, as amended by section 305(b) of this Act, is

amended by adding at the end the following:

‘‘(ee) The importing or offering for import into the United States

of an article of food in violation of the requirements under section

801(m).’’.

(c) RULEMAKING; EFFECTIVE DATE.—

(1) IN GENERAL.—Not later than 18 months after the date

of the enactment of this Act, the Secretary of Health and

Human Services shall promulgate proposed and final regulations for the requirement of providing notice in accordance with

section 801(m) of the Federal Food, Drug, and Cosmetic Act (as

added by subsection (a) of this section). Such requirement of notification takes effect—

(A) upon the effective date of such final regulations; or

81

(B) upon the expiration of such 18-month period if the

final regulations have not been made effective as of the expiration of such period, subject to compliance with the final

regulations when the final regulations are made effective.

(2) DEFAULT; MINIMUM PERIOD OF ADVANCE NOTICE.—If

under paragraph (1) the requirement for providing notice in accordance with section 801(m) of the Federal Food, Drug, and

Cosmetic Act takes effect without final regulations having been

made effective, then for purposes of such requirement, the specified period of time that the notice is required to be made in advance of the time of the importation of the article of food involved or the offering of the food for import shall be not fewer

than eight hours and not more than five days, which shall remain in effect until the final regulations are made effective.

SEC. 308. AUTHORITY TO MARK ARTICLES REFUSED ADMISSION INTO

UNITED STATES.

(a) IN GENERAL.—Section 801 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 381(a)), as amended by section 307(a) of

this Act, is amended by adding at the end the following:

‘‘(n)(1) If a food has been refused admission under subsection

(a), other than such a food that is required to be destroyed, the Secretary may require the owner or consignee of the food to affix to the

container of the food a label that clearly and conspicuously bears

the statement: ‘UNITED STATES: REFUSED ENTRY’.

‘‘(2) All expenses in connection with affixing a label under paragraph (1) shall be paid by the owner or consignee of the food involved, and in default of such payment, shall constitute a lien

against future importations made by such owner or consignee.

‘‘(3) A requirement under paragraph (1) remains in effect until

the Secretary determines that the food involved has been brought

into compliance with this Act.’’.

(b) MISBRANDED FOODS.—Section 403 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at

the end the following:

‘‘(v) If—

‘‘(1) it fails to bear a label required by the Secretary under

section 801(n)(1) (relating to food refused admission into the

United States);

‘‘(2) the Secretary finds that the food presents a threat of serious adverse health consequences or death to humans or animals; and

‘‘(3) upon or after notifying the owner or consignee involved

that the label is required under section 801, the Secretary informs the owner or consignee that the food presents such a

threat.’’.

(c) RULE OF CONSTRUCTION.—With respect to articles of food

that are imported or offered for import into the United States, nothing in this section shall be construed to limit the authority of the

Secretary of Health and Human Services or the Secretary of the

Treasury to require the marking of refused articles of food under

any other provision of law.

SEC. 309. PROHIBITION AGAINST PORT SHOPPING.

Section 402 of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 342) is amended by adding at the end the following:

82

‘‘(h) If it is an article of food imported or offered for import into

the United States and the article of food has previously been refused

admission under section 801(a), unless the person reoffering the article affirmatively establishes, at the expense of the owner or consignee of the article, that the article complies with the applicable requirements of this Act, as determined by the Secretary.’’.

SEC. 310. NOTICES TO STATES REGARDING IMPORTED FOOD.

Chapter IX of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 391 et seq.) is amended by adding at the end the following

section:

‘‘SEC. 908. NOTICES TO STATES REGARDING IMPORTED FOOD.

‘‘(a) IN GENERAL.—If the Secretary has credible evidence or information indicating that a shipment of imported food or portion

thereof presents a threat of serious adverse health consequences or

death to humans or animals, the Secretary shall provide notice regarding such threat to the States in which the food is held or will

be held, and to the States in which the manufacturer, packer, or

distributor of the food is located, to the extent that the Secretary has

knowledge of which States are so involved. In providing notice to a

State, the Secretary shall request the State to take such action as

the State considers appropriate, if any, to protect the public health

regarding the food involved.

‘‘(b) RULE OF CONSTRUCTION.—Subsection (a) may not be construed as limiting the authority of the Secretary with respect to food

under any other provision of this Act.’’.

SEC. 311. GRANTS TO STATES FOR INSPECTIONS.

Chapter IX of the Federal Food, Drug and Cosmetic Act, as

amended by section 310 of this Act, is amended by adding at the

end the following section:

‘‘SEC. 909. GRANTS TO STATES FOR INSPECTIONS.

‘‘(a) IN GENERAL.—The Secretary is authorized to make grants

to States, territories, and Indian tribes (as defined in section 4(e) of

the Indian Self-Determination and Education Assistance Act (25

U.S.C. 450b(e))) that undertake examinations, inspections, and investigations, and related activities under section 702. The funds

provided under such grants shall only be available for the costs of

conducting such examinations, inspections, investigations, and related activities.

‘‘(b) NOTICES REGARDING ADULTERATED IMPORTED FOOD.—The

Secretary may make grants to the States for the purpose of assisting

the States with the costs of taking appropriate action to protect the

public health in response to notification under section 908, including planning and otherwise preparing to take such action.

‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, there are authorized to be appropriated

$10,000,000 for fiscal year 2002, and such sums as may be necessary for each of the fiscal years 2003 through 2006.’’.

SEC. 312. SURVEILLANCE AND INFORMATION GRANTS AND AUTHORITIES.

Part B of title III of the Public Health Service Act (42 U.S.C.

243 et seq.) is amended by inserting after section 317P the following:

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‘‘SEC. 317R. FOOD SAFETY GRANTS.

‘‘(a) IN GENERAL.—The Secretary may award grants to States

and Indian tribes (as defined in section 4(e) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b(e))) to

expand participation in networks to enhance Federal, State, and

local food safety efforts, including meeting the costs of establishing

and maintaining the food safety surveillance, technical, and laboratory capacity needed for such participation. ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, there are authorized to be appropriated

$19,500,000 for fiscal year 2002, and such sums as may be necessary for each of the fiscal years 2003 through 2006.’’.

SEC. 313. SURVEILLANCE OF ZOONOTIC DISEASES.

The Secretary of Health and Human Services, through the

Commissioner of Food and Drugs and the Director of the Centers

for Disease Control and Prevention, and the Secretary of Agriculture

shall coordinate the surveillance of zoonotic diseases.

SEC. 314. AUTHORITY TO COMMISSION OTHER FEDERAL OFFICIALS TO

CONDUCT INSPECTIONS.

Section 702(a) of the Federal Food, Drug and Cosmetic Act (21

U.S.C. 372(a)) is amended— (1) by striking ‘‘(a)’’ and inserting ‘‘(a)(1)’’;

(2) by striking ‘‘In the case of food packed’’ and inserting

the following:

‘‘(3) In the case of food packed’’;

(3) by striking ‘‘For the purposes of this subsection’’ and inserting the following:

‘‘(4) For the purposes of this subsection,’’; and

(4) by inserting after paragraph (1) (as designated by paragraph (1) of this section) the following paragraph:

‘‘(2)(A) In addition to the authority established in paragraph

(1), the Secretary, pursuant to a memorandum of understanding between the Secretary and the head of another Federal department or

agency, is authorized to conduct examinations and investigations for

the purposes of this Act through the officers and employees of such

other department or agency, subject to subparagraph (B). Such a

memorandum shall include provisions to ensure adequate training

of such officers and employees to conduct the examinations and investigations. The memorandum of understanding shall contain provisions regarding reimbursement. Such provisions may, at the sole

discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations or investigations performed under this section by the officers

or employees of the other department or agency. ‘‘(B) A memorandum of understanding under subparagraph (A)

between the Secretary and another Federal department or agency is

effective only in the case of examinations or inspections at facilities

or other locations that are jointly regulated by the Secretary and

such department or agency. ‘‘(C) For any fiscal year in which the Secretary and the head

of another Federal department or agency carries out one or more examinations or inspections under a memorandum of understanding

under subparagraph (A), the Secretary and the head of such department or agency shall with respect to their respective departments or

agencies submit to the committees of jurisdiction (authorizing and

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appropriating) in the House of Representatives and the Senate a report that provides, for such year—

‘‘(i) the number of officers or employees that carried out one

or more programs, projects, or activities under such memorandum;

‘‘(ii) the number of additional articles that were inspected

or examined as a result of such memorandum; and

‘‘(iii) the number of additional examinations or investigations that were carried out pursuant to such memorandum.’’.

SEC. 315. RULE OF CONSTRUCTION.

Nothing in this title, or an amendment made by this title, shall

be construed to alter the jurisdiction between the Secretaries of Agriculture and of Health and Human Services, under applicable statutes and regulations.

Subtitle B—Protection of Drug Supply

SEC. 321. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS;

SHIPPING INFORMATION; DRUG AND DEVICE LISTING.

(a) ANNUAL REGISTRATION; LISTING.—Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended—

(1) in subsection (i)(1)—

(A) by striking ‘‘Any establishment’’ and inserting ‘‘On

or before December 31 of each year, any establishment’’;

and

(B) by striking ‘‘shall register’’ and all that follows and

inserting the following: ‘‘shall, through electronic means in

accordance with the criteria of the Secretary, register with

the Secretary the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such drug or device

in the United States that is known to the establishment,

and the name of each person who imports or offers for import such drug or device to the United States for purposes

of importation.’’; and

(2) in subsection (j)(1), in the first sentence, by striking ‘‘or

(d)’’ and inserting ‘‘(d), or (i)’’.

(b) IMPORTATION; STATEMENT REGARDING REGISTRATION OF

MANUFACTURER.—

(1) IN GENERAL.—Section 801 of the Federal Food, Drug,

and Cosmetic Act, as amended by section 308(a) of this Act, is

amended by adding at the end the following subsection:

‘‘(o) If an article that is a drug or device is being imported or

offered for import into the United States, and the importer, owner,

or consignee of such article does not, at the time of offering the article for import, submit to the Secretary a statement that identifies

the registration under section 510(i) of each establishment that with

respect to such article is required under such section to register with

the Secretary, the article may be refused admission. If the article is

refused admission for failure to submit such a statement, the article

shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such

a statement is submitted to the Secretary. Subsection (b) does not

authorize the delivery of the article pursuant to the execution of a

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bond while the article is so held. The article shall be removed to a

secure facility, as appropriate. During the period of time that such

article is so held, the article shall not be transferred by any person

from the port of entry into the United States for the article, or from

the secure facility to which the article has been removed, as the case

may be.’’.

(2) PROHIBITED ACT.—Section 301 of the Federal Food,

Drug, and Cosmetic Act, as amended by section 307(b) of this

Act, is amended by adding at the end the following:

‘‘(ff) The importing or offering for import into the United States

of a drug or device with respect to which there is a failure to comply

with a request of the Secretary to submit to the Secretary a statement under section 801(o).’’.

(c) EFFECTIVE DATE.—The amendments made by this section

take effect upon the expiration of the 180-day period beginning on

the date of the enactment of this Act.

SEC. 322. REQUIREMENT OF ADDITIONAL INFORMATION REGARDING

IMPORT COMPONENTS INTENDED FOR USE IN EXPORT

PRODUCTS.

(a) IN GENERAL.—Section 801(d)(3) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to read as follows:

‘‘(3)(A) Subject to subparagraph (B), no component of a drug, no

component part or accessory of a device, or other article of device

requiring further processing, which is ready or suitable for use for

health-related purposes, and no article of a food additive, color additive, or dietary supplement, including a product in bulk form,

shall be excluded from importation into the United States under

subsection (a) if each of the following conditions is met:

‘‘(i) The importer of such article of a drug or device or importer of such article of a food additive, color additive, or dietary supplement submits to the Secretary, at the time of initial

importation, a statement in accordance with the following:

‘‘(I) Such statement provides that such article is intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee,

into a drug, biological product, device, food, food additive,

color additive, or dietary supplement that will be exported

by the initial owner or consignee from the United States in

accordance with subsection (e) or section 802, or with section 351(h) of the Public Health Service Act.

‘‘(II) The statement identifies the manufacturer of such

article and each processor, packer, distributor, or other entity that had possession of the article in the chain of possession of the article from the manufacturer to such importer

of the article.

‘‘(III) The statement is accompanied by such certificates

of analysis as are necessary to identify such article, unless

the article is a device or is an article described in paragraph (4).

‘‘(ii) At the time of initial importation and before the delivery of such article to the importer or the initial owner or consignee, such owner or consignee executes a good and sufficient

bond providing for the payment of such liquidated damages in

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the event of default as may be required pursuant to regulations

of the Secretary of the Treasury.

‘‘(iii) Such article is used and exported by the initial owner

or consignee in accordance with the intent described under

clause (i)(I), except for any portions of the article that are destroyed.

‘‘(iv) The initial owner or consignee maintains records on

the use or destruction of such article or portions thereof, as the

case may be, and submits to the Secretary any such records requested by the Secretary.

‘‘(v) Upon request of the Secretary, the initial owner or consignee submits a report that provides an accounting of the exportation or destruction of such article or portions thereof, and

the manner in which such owner or consignee complied with

the requirements of this subparagraph.

‘‘(B) Notwithstanding subparagraph (A), the Secretary may

refuse admission to an article that otherwise would be imported into

the United States under such subparagraph if the Secretary determines that there is credible evidence or information indicating that

such article is not intended to be further processed by the initial

owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive,

color additive, or dietary supplement that will be exported by the

initial owner or consignee from the United States in accordance

with subsection (e) or section 802, or with section 351(h) of the Public Health Service Act.

‘‘(C) This section may not be construed as affecting the responsibility of the Secretary to ensure that articles imported into the

United States under authority of subparagraph (A) meet each of the

conditions established in such subparagraph for importation.’’.

(b) PROHIBITED ACT.—Section 301(w) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 331(w)) is amended to read as

follows:

‘‘(w) The making of a knowingly false statement in any statement, certificate of analysis, record, or report required or requested

under section 801(d)(3); the failure to submit a certificate of analysis as required under such section; the failure to maintain records

or to submit records or reports as required by such section; the release into interstate commerce of any article or portion thereof imported into the United States under such section or any finished

product made from such article or portion, except for export in accordance with section 801(e) or 802, or with section 351(h) of the

Public Health Service Act; or the failure to so export or to destroy

such an article or portions thereof, or such a finished product.’’.

(c) EFFECTIVE DATE.—The amendments made by this section

take effect upon the expiration of the 90-day period beginning on the

date of the enactment of this Act.

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Subtitle C—General Provisions Relating to

Upgrade of Agricultural Security

SEC. 331. EXPANSION OF ANIMAL AND PLANT HEALTH INSPECTION

SERVICE ACTIVITIES.

(a) IN GENERAL.—The Secretary of Agriculture (referred to in

this section as the ‘‘Secretary’’) may utilize existing authorities to

give high priority to enhancing and expanding the capacity of the

Animal and Plant Health Inspection Service to conduct activities

to—

(1) increase the inspection capacity of the Service at international points of origin;

(2) improve surveillance at ports of entry and customs;

(3) enhance methods of protecting against the introduction

of plant and animal disease organisms by terrorists;

(4) develop new and improve existing strategies and technologies for dealing with intentional outbreaks of plant and

animal disease arising from acts of terrorism or from unintentional introduction, including—

(A) establishing cooperative agreements among Veterinary Services of the Animal and Plant Health Inspection

Service, State animal health commissions and regulatory

agencies for livestock and poultry health, and private veterinary practitioners to enhance the preparedness and ability of Veterinary Services and the commissions and agencies to respond to outbreaks of such animal diseases; and

(B) strengthening planning and coordination with

State and local agencies, including—

(i) State animal health commissions and regulatory agencies for livestock and poultry health; and

(ii) State agriculture departments; and

(5) otherwise improve the capacity of the Service to protect

against the threat of bioterrorism.

(b) AUTOMATED RECORDKEEPING SYSTEM.—The Administrator

of the Animal and Plant Health Inspection Service may implement

a central automated recordkeeping system to provide for the reliable

tracking of the status of animal and plant shipments, including

those shipments on hold at ports of entry and customs. The Secretary shall ensure that such a system shall be fully accessible to

or fully integrated with the Food Safety Inspection Service.

(c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to

be appropriated to carry out this section, $30,000,000 for fiscal year

2002, and such sums as may be necessary for each subsequent fiscal

year.

SEC. 332. EXPANSION OF FOOD SAFETY INSPECTION SERVICE ACTIVITIES.

(a) IN GENERAL.—The Secretary of Agriculture may utilize existing authorities to give high priority to enhancing and expanding

the capacity of the Food Safety Inspection Service to conduct activities to—

(1) enhance the ability of the Service to inspect and ensure

the safety and wholesomeness of meat and poultry products;

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(2) improve the capacity of the Service to inspect international meat and meat products, poultry and poultry products,

and egg products at points of origin and at ports of entry;

(3) strengthen the ability of the Service to collaborate with

relevant agencies within the Department of Agriculture and

with other entities in the Federal Government, the States, and

Indian tribes (as defined in section 4(e) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b(e)))

through the sharing of information and technology; and

(4) otherwise expand the capacity of the Service to protect

against the threat of bioterrorism.

(b) AUTHORIZATION OF APPROPRIATIONS.—There is authorized

to be appropriated to carry out this section, $15,000,000 for fiscal

year 2002, and such sums as may be necessary for each subsequent

fiscal year.

SEC. 333. BIOSECURITY UPGRADES AT THE DEPARTMENT OF AGRICULTURE.

There is authorized to be appropriated for fiscal year 2002,

$180,000,000 for the purpose of enabling the Agricultural Research

Service to conduct building upgrades to modernize existing facilities, of which (1) $100,000,000 shall be allocated for renovation, updating, and expansion of the Biosafety Level 3 laboratory and animal research facilities at the Plum Island Animal Disease Center

(Greenport, New York), and of which (2) $80,000,000 shall be allocated for the Agricultural Research Service/Animal and Plant

Health Inspection Service facility in Ames, Iowa. There are authorized to be appropriated such sums as may be necessary for fiscal

years 2003 through 2006 for the purpose described in the preceding

sentence, for the planning and design of an Agricultural Research

Service biocontainment laboratory for poultry research in Athens,

Georgia, and for the planning, updating, and renovation of the Arthropod-Borne Animal Disease Laboratory in Laramie, Wyoming.

SEC. 334. AGRICULTURAL BIOSECURITY.

(a) SECURITY AT COLLEGES AND UNIVERSITIES.—

(1) GRANTS.—The Secretary of Agriculture (referred to in

this section as the ‘‘Secretary’’) may award grants to covered entities to review security standards and practices at their facilities in order to protect against bioterrorist attacks.

(2) COVERED ENTITIES.—Covered entities under this subsection are colleges or universities that—

(A) are colleges or universities as defined in section

1404 of the National Agricultural Research, Extension, and

Teaching Policy Act of 1977 (7 U.S.C. 3103); and

(B) have programs in food and agricultural sciences, as

defined in such section.

(3) LIMITATION.—Each individual covered entity may be

awarded one grant under paragraph (1), the amount of which

shall not exceed $50,000.

(4) CONTRACT AUTHORITY.—Colleges and universities receiving grants under paragraph (1) may use such grants to

enter into contracts with independent private organizations

with established and demonstrated security expertise to conduct

the security reviews specified in such paragraph.

(b) GUIDELINES FOR AGRICULTURAL BIOSECURITY.—

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(1) IN GENERAL.—The Secretary may award grants to associations of food producers or consortia of such associations for

the development and implementation of educational programs

to improve biosecurity on farms in order to ensure the security

of farm facilities against potential bioterrorist attacks.

(2) LIMITATION.—Each individual association eligible

under paragraph (1) may be awarded one grant under such

paragraph, the amount of which shall not exceed $100,000.

Each consortium eligible under paragraph (1) may be awarded

one grant under such paragraph, the amount of which shall not

exceed $100,000 per association participating in the consortium.

(3) CONTRACT AUTHORITY.—Associations of food producers

receiving grants under paragraph (1) may use such grants to

enter into contracts with independent private organizations

with established and demonstrated expertise in biosecurity to

assist in the development and implementation of educational

programs to improve biosecurity specified in such paragraph.

(c) AUTHORIZATION OF APPROPRIATIONS.—There are authorized

to be appropriated to carry out this section such sums as may be

necessary for each fiscal year.

SEC. 335. AGRICULTURAL BIOTERRORISM RESEARCH AND DEVELOPMENT.

(a) IN GENERAL.—The Secretary of Agriculture (referred to in

this section as the ‘‘Secretary’’) may utilize existing research authorities and research programs to protect the food supply of the United

States by conducting and supporting research activities to—

(1) enhance the capability of the Secretary to respond in a

timely manner to emerging or existing bioterrorist threats to the

food and agricultural system of the United States;

(2) develop new and continue partnerships with institutions

of higher education and other institutions to help form stable,

long-term programs to enhance the biosecurity and food safety

of the United States, including the coordination of the development, implementation, and enhancement of diverse capabilities

for addressing threats to the nation’s agricultural economy and

food supply, with special emphasis on planning, training, outreach, and research activities related to vulnerability analyses,

incident response, detection, and prevention technologies;

(3) strengthen coordination with the intelligence community

to better identify research needs and evaluate materials or information acquired by the intelligence community relating to

potential threats to United States agriculture;

(4) expand the involvement of the Secretary with international organizations dealing with plant and animal disease

control;

(5) continue research to develop rapid detection field test

kits to detect biological threats to plants and animals and to

provide such test kits to State and local agencies preparing for

or responding to bioterrorism;

(6) develop an agricultural bioterrorism early warning surveillance system through enhancing the capacity of and coordination between State veterinary diagnostic laboratories, Federal

and State agricultural research facilities, and public health

agencies; and

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(7) otherwise improve the capacity of the Secretary to protect against the threat of bioterrorism.

(b) AUTHORIZATION OF APPROPRIATIONS.—There is authorized

to be appropriated to carry out this section, $190,000,000 for fiscal

year 2002, and such sums as may be necessary for each subsequent

fiscal year.

SEC. 336. ANIMAL ENTERPRISE TERRORISM PENALTIES.

(a) IN GENERAL.—Section 43(a) of title 18, United States Code,

is amended to read as follows:

‘‘(a) OFFENSE.—Whoever—

‘‘(1) travels in interstate or foreign commerce, or uses or

causes to be used the mail or any facility in interstate or foreign

commerce for the purpose of causing physical disruption to the

functioning of an animal enterprise; and

‘‘(2) intentionally damages or causes the loss of any property (including animals or records) used by the animal enterprise, or conspires to do so,

shall be punished as provided for in subsection (b).’’.

(b) PENALTIES.—Section 43(b) of title 18, United States Code, is

amended to read as follows:

‘‘(b) PENALTIES.—

‘‘(1) ECONOMIC DAMAGE.—Any person who, in the course of

a violation of subsection (a), causes economic damage not exceeding $10,000 to an animal enterprise shall be fined under

this title or imprisoned not more than 6 months, or both.

‘‘(2) MAJOR ECONOMIC DAMAGE.—Any person who, in the

course of a violation of subsection (a), causes economic damage

exceeding $10,000 to an animal enterprise shall be fined under

this title or imprisoned not more than 3 years, or both.

‘‘(3) SERIOUS BODILY INJURY.—Any person who, in the

course of a violation of subsection (a), causes serious bodily injury to another individual shall be fined under this title or imprisoned not more than 20 years, or both.

‘‘(4) DEATH.—Any person who, in the course of a violation

of subsection (a), causes the death of an individual shall be

fined under this title and imprisoned for life or for any term of

years.’’.

(c) RESTITUTION.—Section 43(c) of title 18, United States Code,

is amended—

(1) in paragraph (1), by striking ‘‘and’’ at the end;

(2) in paragraph (2), by striking the period at the end and

inserting ‘‘; and’’; and

(3) by adding at the end the following:

‘‘(3) for any other economic damage resulting from the offense.’’.

TITLE IV—DRINKING WATER SECURITY

AND SAFETY

SEC. 401. TERRORIST AND OTHER INTENTIONAL ACTS.

The Safe Drinking Water Act (title XIV of the Public Health

Service Act) is amended by inserting the following new section after

section 1432:

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‘‘SEC. 1433. TERRORIST AND OTHER INTENTIONAL ACTS.

‘‘(a) VULNERABILITY ASSESSMENTS.—(1) Each community water

system serving a population of greater than 3,300 persons shall conduct an assessment of the vulnerability of its system to a terrorist

attack or other intentional acts intended to substantially disrupt the

ability of the system to provide a safe and reliable supply of drinking water. The vulnerability assessment shall include, but not be

limited to, a review of pipes and constructed conveyances, physical

barriers, water collection, pretreatment, treatment, storage and distribution facilities, electronic, computer or other automated systems

which are utilized by the public water system, the use, storage, or

handling of various chemicals, and the operation and maintenance

of such system. The Administrator, not later than August 1, 2002,

after consultation with appropriate departments and agencies of the

Federal Government and with State and local governments, shall

provide baseline information to community water systems required

to conduct vulnerability assessments regarding which kinds of terrorist attacks or other intentional acts are the probable threats to—

‘‘(A) substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water; or

‘‘(B) otherwise present significant public health concerns.

‘‘(2) Each community water system referred to in paragraph (1)

shall certify to the Administrator that the system has conducted an

assessment complying with paragraph (1) and shall submit to the

Administrator a written copy of the assessment. Such certification

and submission shall be made prior to:

‘‘(A) March 31, 2003, in the case of systems serving a population of 100,000 or more.

‘‘(B) December 31, 2003, in the case of systems serving a

population of 50,000 or more but less than 100,000.

‘‘(C) June 30, 2004, in the case of systems serving a population greater than 3,300 but less than 50,000.

‘‘(3) Except for information contained in a certification under

this subsection identifying the system submitting the certification

and the date of the certification, all information provided to the Administrator under this subsection and all information derived therefrom shall be exempt from disclosure under section 552 of title 5 of

the United States Code.

‘‘(4) No community water system shall be required under State

or local law to provide an assessment described in this section to

any State, regional, or local governmental entity solely by reason of

the requirement set forth in paragraph (2) that the system submit

such assessment to the Administrator.

‘‘(5) Not later than November 30, 2002, the Administrator, in

consultation with appropriate Federal law enforcement and intelligence officials, shall develop such protocols as may be necessary to

protect the copies of the assessments required to be submitted under

this subsection (and the information contained therein) from unauthorized disclosure. Such protocols shall ensure that—

‘‘(A) each copy of such assessment, and all information contained in or derived from the assessment, is kept in a secure location;

‘‘(B) only individuals designated by the Administrator may

have access to the copies of the assessments; and

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‘‘(C) no copy of an assessment, or part of an assessment, or

information contained in or derived from an assessment shall

be available to anyone other than an individual designated by

the Administrator.

At the earliest possible time prior to November 30, 2002, the Administrator shall complete the development of such protocols for the

purpose of having them in place prior to receiving any vulnerability

assessments from community water systems under this subsection. ‘‘(6)(A) Except as provided in subparagraph (B), any individual

referred to in paragraph (5)(B) who acquires the assessment submitted under paragraph (2), or any reproduction of such assessment, or any information derived from such assessment, and who

knowingly or recklessly reveals such assessment, reproduction, or information other than— ‘‘(i) to an individual designated by the Administrator under

paragraph (5), ‘‘(ii) for purposes of section 1445 or for actions under section 1431, or ‘‘(iii) for use in any administrative or judicial proceeding to

impose a penalty for failure to comply with this section,

shall upon conviction be imprisoned for not more than one year or

fined in accordance with the provisions of chapter 227 of title 18,

United States Code, applicable to class A misdemeanors, or both,

and shall be removed from Federal office or employment. ‘‘(B) Notwithstanding subparagraph (A), an individual referred

to in paragraph (5)(B) who is an officer or employee of the United

States may discuss the contents of a vulnerability assessment submitted under this section with a State or local official. ‘‘(7) Nothing in this section authorizes any person to withhold

any information from Congress or from any committee or subcommittee of Congress. ‘‘(b) EMERGENCY RESPONSE PLAN.—Each community water system serving a population greater than 3,300 shall prepare or revise,

where necessary, an emergency response plan that incorporates the

results of vulnerability assessments that have been completed. Each

such community water system shall certify to the Administrator, as

soon as reasonably possible after the enactment of this section, but

not later than 6 months after the completion of the vulnerability assessment under subsection (a), that the system has completed such

plan. The emergency response plan shall include, but not be limited

to, plans, procedures, and identification of equipment that can be

implemented or utilized in the event of a terrorist or other intentional attack on the public water system. The emergency response

plan shall also include actions, procedures, and identification of

equipment which can obviate or significantly lessen the impact of

terrorist attacks or other intentional actions on the public health

and the safety and supply of drinking water provided to communities and individuals. Community water systems shall, to the extent possible, coordinate with existing Local Emergency Planning

Committees established under the Emergency Planning and Community Right-to-Know Act (42 U.S.C. 11001, et seq.) when preparing or revising an emergency response plan under this subsection.

‘‘(c) RECORD MAINTENANCE.—Each community water system

shall maintain a copy of the emergency response plan completed

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pursuant to subsection (b) for 5 years after such plan has been certified to the Administrator under this section.

‘‘(d) GUIDANCE TO SMALL PUBLIC WATER SYSTEMS.—The Administrator shall provide guidance to community water systems

serving a population of less than 3,300 persons on how to conduct

vulnerability assessments, prepare emergency response plans, and

address threats from terrorist attacks or other intentional actions

designed to disrupt the provision of safe drinking water or significantly affect the public health or significantly affect the safety or

supply of drinking water provided to communities and individuals.

‘‘(e) FUNDING.—(1) There are authorized to be appropriated to

carry out this section not more than $160,000,000 for the fiscal year

2002 and such sums as may be necessary for the fiscal years 2003

through 2005.

‘‘(2) The Administrator, in coordination with State and local

governments, may use funds made available under paragraph (1) to

provide financial assistance to community water systems for purposes of compliance with the requirements of subsections (a) and (b)

and to community water systems for expenses and contracts designed to address basic security enhancements of critical importance

and significant threats to public health and the supply of drinking

water as determined by a vulnerability assessment conducted under

subsection (a). Such basic security enhancements may include, but

shall not be limited to the following:

‘‘(A) the purchase and installation of equipment for detection of intruders;

‘‘(B) the purchase and installation of fencing, gating, lighting, or security cameras;

‘‘(C) the tamper-proofing of manhole covers, fire hydrants,

and valve boxes;

‘‘(D) the rekeying of doors and locks;

‘‘(E) improvements to electronic, computer, or other automated systems and remote security systems;

‘‘(F) participation in training programs, and the purchase

of training manuals and guidance materials, relating to security against terrorist attacks;

‘‘(G) improvements in the use, storage, or handling of various chemicals; and

‘‘(H) security screening of employees or contractor support

services.

Funding under this subsection for basic security enhancements shall

not include expenditures for personnel costs, or monitoring, operation, or maintenance of facilities, equipment, or systems.

‘‘(3) The Administrator may use not more than $5,000,000 from

the funds made available under paragraph (1) to make grants to

community water systems to assist in responding to and alleviating

any vulnerability to a terrorist attack or other intentional acts intended to substantially disrupt the ability of the system to provide

a safe and reliable supply of drinking water (including sources of

water for such systems) which the Administrator determines to

present an immediate and urgent security need.

‘‘(4) The Administrator may use not more than $5,000,000 from

the funds made available under paragraph (1) to make grants to

community water systems serving a population of less than 3,300

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persons for activities and projects undertaken in accordance with

the guidance provided to such systems under subsection (d).

SEC. 402. OTHER SAFE DRINKING WATER ACT AMENDMENTS.

The Safe Drinking Water Act (title XIV of the Public Health

Service Act) is amended by inserting the following new sections after

section 1433 (as added by section 401 of this Act):

‘‘SEC. 1434. CONTAMINANT PREVENTION, DETECTION AND RESPONSE.

‘‘(a) IN GENERAL.—The Administrator, in consultation with the

Centers for Disease Control and, after consultation with appropriate

departments and agencies of the Federal Government and with

State and local governments, shall review (or enter into contracts or

cooperative agreements to provide for a review of) current and future methods to prevent, detect and respond to the intentional introduction of chemical, biological or radiological contaminants into

community water systems and source water for community water

systems, including each of the following:

‘‘(1) Methods, means and equipment, including real time

monitoring systems, designed to monitor and detect various levels of chemical, biological, and radiological contaminants or indicators of contaminants and reduce the likelihood that such

contaminants can be successfully introduced into public water

systems and source water intended to be used for drinking

water.

‘‘(2) Methods and means to provide sufficient notice to operators of public water systems, and individuals served by such

systems, of the introduction of chemical, biological or radiological contaminants and the possible effect of such introduction on public health and the safety and supply of drinking

water.

‘‘(3) Methods and means for developing educational and

awareness programs for community water systems.

‘‘(4) Procedures and equipment necessary to prevent the

flow of contaminated drinking water to individuals served by

public water systems. ‘‘(5) Methods, means, and equipment which could negate or

mitigate deleterious effects on public health and the safety and

supply caused by the introduction of contaminants into water

intended to be used for drinking water, including an examination of the effectiveness of various drinking water technologies

in removing, inactivating, or neutralizing biological, chemical,

and radiological contaminants. ‘‘(6) Biomedical research into the short-term and long-term

impact on public health of various chemical, biological and radiological contaminants that may be introduced into public

water systems through terrorist or other intentional acts.

‘‘(b) FUNDING.—For the authorization of appropriations to carry

out this section, see section 1435(e).

‘‘SEC. 1435. SUPPLY DISRUPTION PREVENTION, DETECTION AND RESPONSE.

‘‘(a) DISRUPTION OF SUPPLY OR SAFETY.—The Administrator, in

coordination with the appropriate departments and agencies of the

Federal Government, shall review (or enter into contracts or cooperative agreements to provide for a review of) methods and means by

which terrorists or other individuals or groups could disrupt the

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supply of safe drinking water or take other actions against water

collection, pretreatment, treatment, storage and distribution facilities which could render such water significantly less safe for human

consumption, including each of the following:

‘‘(1) Methods and means by which pipes and other constructed conveyances utilized in public water systems could be

destroyed or otherwise prevented from providing adequate supplies of drinking water meeting applicable public health standards.

‘‘(2) Methods and means by which collection, pretreatment,

treatment, storage and distribution facilities utilized or used in

connection with public water systems and collection and

pretreatment storage facilities used in connection with public

water systems could be destroyed or otherwise prevented from

providing adequate supplies of drinking water meeting applicable public health standards.

‘‘(3) Methods and means by which pipes, constructed conveyances, collection, pretreatment, treatment, storage and distribution systems that are utilized in connection with public

water systems could be altered or affected so as to be subject to

cross-contamination of drinking water supplies.

‘‘(4) Methods and means by which pipes, constructed conveyances, collection, pretreatment, treatment, storage and distribution systems that are utilized in connection with public

water systems could be reasonably protected from terrorist attacks or other acts intended to disrupt the supply or affect the

safety of drinking water.

‘‘(5) Methods and means by which information systems, including process controls and supervisory control and data acquisition and cyber systems at community water systems could

be disrupted by terrorists or other groups.

‘‘(b) ALTERNATIVE SOURCES.—The review under this section

shall also include a review of the methods and means by which alternative supplies of drinking water could be provided in the event

of the destruction, impairment or contamination of public water systems.

‘‘(c) REQUIREMENTS AND CONSIDERATIONS.—In carrying out this

section and section 1434—

‘‘(1) the Administrator shall ensure that reviews carried out

under this section reflect the needs of community water systems

of various sizes and various geographic areas of the United

States; and

‘‘(2) the Administrator may consider the vulnerability of, or

potential for forced interruption of service for, a region or service area, including community water systems that provide service to the National Capital area.

‘‘(d) INFORMATION SHARING.—As soon as practicable after reviews carried out under this section or section 1434 have been evaluated, the Administrator shall disseminate, as appropriate as determined by the Administrator, to community water systems information on the results of the project through the Information Sharing

and Analysis Center, or other appropriate means.

‘‘(e) FUNDING.—There are authorized to be appropriated to carry

out this section and section 1434 not more than $15,000,000 for the

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fiscal year 2002 and such sums as may be necessary for the fiscal

years 2003 through 2005.’’.

SEC. 403. MISCELLANEOUS AND TECHNICAL AMENDMENTS.

The Safe Drinking Water Act is amended as follows:

(1) Section 1414(i)(1) is amended by inserting ‘‘1433’’ after

‘‘1417’’.

(2) Section 1431 is amended by inserting in the first sentence after ‘‘drinking water’’ the following: ‘‘, or that there is a

threatened or potential terrorist attack (or other intentional act

designed to disrupt the provision of safe drinking water or to

impact adversely the safety of drinking water supplied to communities and individuals), which’’.

(3) Section 1432 is amended as follows:

(A) By striking ‘‘5 years’’ in subsection (a) and inserting

‘‘20 years’’.

(B) By striking ‘‘3 years’’ in subsection (b) and inserting

‘‘10 years’’.

(C) By striking ‘‘$50,000’’ in subsection (c) and inserting ‘‘$1,000,000’’.

(D) By striking ‘‘$20,000’’ in subsection (c) and inserting ‘‘$100,000’’.

(4) Section 1442 is amended as follows:

(A) By striking ‘‘this subparagraph’’ in subsection (b)

and inserting ‘‘this subsection’’.

(B) By amending subsection (d) to read as follows:

‘‘(d) There are authorized to be appropriated to carry out subsection (b) not more than $35,000,000 for the fiscal year 2002 and

such sums as may be necessary for each fiscal year thereafter.’’.

TITLE V—ADDITIONAL PROVISIONS

Subtitle A—Prescription Drug User Fees

SEC. 501. SHORT TITLE.

This subtitle may be cited as the ‘‘Prescription Drug User Fee

Amendments of 2002’’.

SEC. 502. FINDINGS.

The Congress finds that—

(1) prompt approval of safe and effective new drugs and

other therapies is critical to the improvement of the public

health so that patients may enjoy the benefits provided by these

therapies to treat and prevent illness and disease;

(2) the public health will be served by making additional

funds available for the purpose of augmenting the resources of

the Food and Drug Administration that are devoted to the process for the review of human drug applications and the assurance of drug safety;

(3) the provisions added by the Prescription Drug User Fee

Act of 1992, as amended by the Food and Drug Administration

Modernization Act of 1997, have been successful in substantially reducing review times for human drug applications and

should be—

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(A) reauthorized for an additional 5 years, with certain

technical improvements; and

(B) carried out by the Food and Drug Administration

with new commitments to implement more ambitious and

comprehensive improvements in regulatory processes of the

Food and Drug Administration, including— (i) strengthening and improving the review and

monitoring of drug safety;

(ii) considering greater interaction between the

agency and sponsors during the review of drugs and

biologics intended to treat serious diseases and lifethreatening diseases; and

(iii) developing principles for improving first-cycle

reviews; and

(4) the fees authorized by amendments made in this subtitle

will be dedicated towards expediting the drug development

process and the process for the review of human drug applications as set forth in the goals identified for purposes of part 2

of subchapter C of chapter VII of the Federal Food, Drug, and

Cosmetic Act, in the letters from the Secretary of Health and

Human Services to the chairman of the Committee on Energy

and Commerce of the House of Representatives and the chairman of the Committee on Health, Education, Labor and Pensions of the Senate, as set forth in the Congressional Record.

SEC. 503. DEFINITIONS.

Section 735 of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 379g) is amended— (1) in paragraph (1), in the matter after and below subparagraph (C), by striking ‘‘licensure, as described in subparagraph (D)’’ and inserting ‘‘licensure, as described in subparagraph (C)’’;

(2) in paragraph (3)— (A) in subparagraph (A), by striking ‘‘and’’ at the end;

(B) in subparagraph (B), by striking the period and inserting ‘‘, and’’;

(C) by inserting after subparagraph (B) the following

subparagraph: ‘‘(C) which is on the list of products described in section 505(j)(7)(A) or is on a list created and maintained by

the Secretary of products approved under human drug applications under section 351 of the Public Health Service

Act.’’; and

(D) in the matter after and below subparagraph (C) (as

added by subparagraph (C) of this paragraph), by striking

‘‘Service Act,’’ and all that follows through ‘‘biological product’’ and inserting the following: ‘‘Service Act. Such term

does not include a biological product’’;

(3) in paragraph (6), by adding at the end the following

subparagraph: ‘‘(F) In the case of drugs approved after October 1,

2002, under human drug applications or supplements: collecting, developing, and reviewing safety information on the

drugs, including adverse event reports, during a period of

time after approval of such applications or supplements,

not to exceed three years.’’; and

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(4) in paragraph (8)— (A) by striking the matter after and below subparagraph (B);

(B) by striking subparagraph (B);

(C) by striking ‘‘is the lower of’’ and all that follows

through ‘‘Consumer Price Index’’ and inserting ‘‘is the Consumer Price Index’’; and

(D) by striking ‘‘1997, or’’ and inserting ‘‘1997.’’.

SEC. 504. AUTHORITY TO ASSESS AND USE DRUG FEES.

(a) TYPES OF FEES.—Section 736(a) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 379h(a)) is amended— (1) in the matter preceding paragraph (1), by striking ‘‘fiscal year 1998’’ and inserting ‘‘fiscal year 2003’’;

(2) in paragraph (1)(A)— (A) in each of clauses (i) and (ii), by striking ‘‘in subsection (b)’’ and inserting ‘‘under subsection (c)(4)’’; and

(B) in clause (ii), by adding at the end the following

sentence: ‘‘Such fee shall be half of the amount of the fee

established under clause (i).’’;

(3) in paragraph (2)(A), in the matter after and below

clause (ii)—

(A) by striking ‘‘in subsection (b)’’ and inserting ‘‘under

subsection (c)(4)’’; and

(B) by striking ‘‘payable on or before January 31’’ and

inserting ‘‘payable on or before October 1’’; and

(4) in paragraph (3)— (A) by amending subparagraph (A) to read as follows:

‘‘(A) IN GENERAL.—Except as provided in subparagraph

(B), each person who is named as the applicant in a human

drug application, and who, after September 1, 1992, had

pending before the Secretary a human drug application or

supplement, shall pay for each such prescription drug product the annual fee established under subsection (c)(4). Such

fee shall be payable on or before October 1 of each year.

Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.’’; and

(B) in subparagraph (B), by striking ‘‘The listing’’ and

all that follows through ‘‘filed under section 505(b)(2)’’ and

inserting the following: ‘‘A prescription drug product shall

not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section

505(j)(7)(A) with a potency described in terms of per 100

mL, or if such product is the same product as another

product approved under an application filed under section

505(b)’’.

(b) FEE AMOUNTS.—Section 736(b) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows:

‘‘(b) FEE REVENUE AMOUNTS.—Except as provided in subsections (c), (d), (f), and (g), fees under subsection (a) shall be established to generate the following revenue amounts:

‘‘Type of Fee Revenue Fiscal Year 2003 Fiscal Year 2004 Fiscal Year 2005 Fiscal Year 2006 Fiscal Year 2007

Application/Supplement ................... $74,300,000 $77,000,000 $84,000,000 $86,434,000 $86,434,000

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‘‘Type of Fee Revenue Fiscal Year 2003 Fiscal Year 2004 Fiscal Year 2005 Fiscal Year 2006 Fiscal Year 2007

Establishment .................................. $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000

Product ............................................. $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000

Total Fee Revenue ........................... $222,900,000 $231,000,000 $252,000,000 $259,300,000 $259,300,000

If, after the date of the enactment of the Prescription Drug User Fee

Amendments of 2002, legislation is enacted requiring the Secretary

to fund additional costs of the retirement of Federal personnel, fee

revenue amounts shall be increased in each year by the amount necessary to fully fund the portion of such additional costs that are attributable to the process for the review of human drug applications.’’.

(c) ADJUSTMENTS.—Section 736(c) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 379h(c)) is amended— (1) in paragraph (1)— (A) in the matter preceding subparagraph (A), by striking ‘‘fees and total fee revenues’’ and inserting ‘‘revenues’’;

(B) in subparagraph (A)— (i) by striking ‘‘during the preceding fiscal year’’;

and

(ii) by striking ‘‘, or’’ and inserting the following: ‘‘for the 12 month period ending June 30 preceding the

fiscal year for which fees are being established, or’’;

(C) in subparagraph (B), by striking ‘‘for such fiscal

year’’ and inserting ‘‘for the previous fiscal year’’; and

(D) in the matter after and below subparagraph (B), by

striking ‘‘fiscal year 1997’’; and inserting ‘‘fiscal year 2003’’;

(2) by redesignating paragraphs (2) and (3) as paragraphs

(4) and (5), respectively;

(3) by inserting after paragraph (1) the following paragraphs: ‘‘(2) WORKLOAD ADJUSTMENT.—Beginning with fiscal year

2004, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary for

the process for the review of human drug applications. With respect to such adjustment: ‘‘(A) The adjustment shall be determined by the Secretary based on a weighted average of the change in the

total number of human drug applications, commercial investigational new drug applications, efficacy supplements,

and manufacturing supplements submitted to the Secretary. The Secretary shall publish in the Federal Register

the fee revenues and fees resulting from the adjustment and

the supporting methodologies.

‘‘(B) Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the

fee revenues for the fiscal year established in subsection (b),

as adjusted for inflation under paragraph (1).

‘‘(3) FINAL YEAR ADJUSTMENT.—For fiscal year 2007, the

Secretary may, in addition to adjustments under paragraphs

(1) and (2), further increase the fee revenues and fees established in subsection (b) if such an adjustment is necessary to

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provide for not more than three months of operating reserves of

carryover user fees for the process for the review of human drug

applications for the first three months of fiscal year 2008. If

such an adjustment is necessary, the rationale for the amount

of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2007. If the Secretary has carryover balances for such process in excess of three

months of such operating reserves, the adjustment under this

paragraph shall not be made.’’; and

(4) in paragraph (4) (as redesignated by paragraph (2) of

this subsection), by amending such paragraph to read as follows:‘‘(4) ANNUAL FEE SETTING.—The Secretary shall, 60 days

before the start of each fiscal year that begins after September

30, 2002, establish, for the next fiscal year, application, product, and establishment fees under subsection (a), based on the

revenue amounts established under subsection (b) and the adjustments provided under this subsection.’’. (d) FEE WAIVER OR REDUCTION.—Section 736(d)) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended— (1) in paragraph (1)— (A) in subparagraph (C), by inserting ‘‘or’’ after the

comma at the end;

(B) by striking subparagraph (D); and

(C) by redesignating subparagraph (E) as subparagraph (D); and

(2) in paragraph (3), in each of subparagraphs (A) and (B),

by striking ‘‘paragraph (1)(E)’’ each place such term appears

and inserting ‘‘paragraph (1)(D)’’. (e) ASSESSMENT OF FEES.—Section 736(f) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 379h(f)) is amended— (1) in the heading for the subsection, by striking ‘‘ASSESS- MENT OF FEES.—’’ and inserting ‘‘LIMITATIONS.—’’; and

(2) in paragraph (1), by striking the heading for the paragraph and all that follows through ‘‘fiscal year beginning’’ and

inserting the following: ‘‘IN GENERAL.—Fees under subsection

(a) shall be refunded for a fiscal year beginning’’. (f) CREDITING AND AVAILABILITY OF FEES.— (1) IN GENERAL.—Section 736(g)(1) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 379h(g)(1)) is amended by

striking ‘‘Fees collected for a fiscal year’’ and all that follows

through ‘‘fiscal year limitation.’’ and inserting the following: ‘‘Fees authorized under subsection (a) shall be collected and

available for obligation only to the extent and in the amount

provided in advance in appropriations Acts. Such fees are authorized to remain available until expended.’’. (2) COLLECTIONS AND APPROPRIATION ACTS.—Section

736(g)(2) of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 379h(g)(2)) is amended— (A) by redesignating subparagraphs (A) and (B) as

clauses (i) and (ii), respectively;

(B) by striking ‘‘(2) COLLECTIONS’’ and all that follows

through ‘‘the amount specified’’ in clause (i) (as so redesignated) and inserting the following:

‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.—

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‘‘(A) IN GENERAL.—The fees authorized by this

section—

‘‘(i) shall be retained in each fiscal year in an

amount not to exceed the amount specified’’;

(C) by moving clause (ii) (as so redesignated) two ems

to the right; and

(D) by adding at the end the following subparagraph:

‘‘(B) COMPLIANCE.—The Secretary shall be considered

to have met the requirements of subparagraph (A)(ii) in any

fiscal year if the costs funded by appropriations and allocated for the process for the review of human drug

applications— ‘‘(i) are not more than 3 percent below the level

specified in subparagraph (A)(ii); or ‘‘(ii)(I) are more than 3 percent below the level

specified in subparagraph (A)(ii), and fees assessed for

the fiscal year following the subsequent fiscal year are

decreased by the amount in excess of 3 percent by

which such costs fell below the level specified in such

subparagraph; and ‘‘(II) such costs are not more than 5 percent below

the level specified in such subparagraph.’’. (3) AUTHORIZATION OF APPROPRIATIONS.—Section 736(g)(3)

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

379h(g)(3)) is amended by striking subparagraphs (A) through

(E) and inserting the following: ‘‘(A) $222,900,000 for fiscal year 2003;

‘‘(B) $231,000,000 for fiscal year 2004;

‘‘(C) $252,000,000 for fiscal year 2005;

‘‘(D) $259,300,000 for fiscal year 2006; and

‘‘(E) $259,300,000 for fiscal year 2007;’’.

SEC. 505. ACCOUNTABILITY AND REPORTS.

(a) PUBLIC ACCOUNTABILITY.— (1) CONSULTATION.—In developing recommendations to the

Congress for the goals and plans for meeting the goals for the

process for the review of human drug applications for the fiscal

years after fiscal year 2007, and for the reauthorization of sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act,

the Secretary of Health and Human Services (referred to in this

section as the ‘‘Secretary’’) shall consult with the Committee on

Energy and Commerce of the House of Representatives, the

Committee on Health, Education, Labor, and Pensions of the

Senate, appropriate scientific and academic experts, health care

professionals, representatives of patient and consumer advocacy

groups, and the regulated industry.

(2) RECOMMENDATIONS.—The Secretary shall publish in the

Federal Register recommendations under paragraph (1), after

negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such

paragraph; shall hold a meeting at which the public may

present its views on such recommendations; and shall provide

for a period of 30 days for the public to provide written comments on such recommendations.

(b) PERFORMANCE REPORT.—Beginning with fiscal year 2003,

not later than 60 days after the end of each fiscal year during which

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fees are collected under part 2 of subchapter C of chapter VII of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the

Secretary of Health and Human Services shall prepare and submit

to the President, the Committee on Energy and Commerce of the

House of Representatives, and the Committee on Health, Education,

Labor, and Pensions of the Senate a report concerning the progress

of the Food and Drug Administration in achieving the goals identified in the letters described in section 502(4) during such fiscal year

and the future plans of the Food and Drug Administration for meeting the goals.

(c) FISCAL REPORT.—Beginning with fiscal year 2003, not later

than 120 days after the end of each fiscal year during which fees

are collected under the part described in subsection (b), the Secretary of Health and Human Services shall prepare and submit to

the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report on the implementation of the authority

for such fees during such fiscal year and the use, by the Food and

Drug Administration, of the fees collected during such fiscal year for

which the report is made.

SEC. 506. REPORTS OF POSTMARKETING STUDIES.

Section 506B of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 356b) is amended by adding at the end the following subsections:

‘‘(d) DISCLOSURE.—If a sponsor fails to complete an agreed

upon study required by this section by its original or otherwise negotiated deadline, the Secretary shall publish a statement on the

Internet site of the Food and Drug Administration stating that the

study was not completed and, if the reasons for such failure to complete the study were not satisfactory to the Secretary, a statement

that such reasons were not satisfactory to the Secretary.

‘‘(e) NOTIFICATION.—With respect to studies of the type required

under section 506(b)(2)(A) or under section 314.510 or 601.41 of title

21, Code of Federal Regulations, as each of such sections was in effect on the day before the effective date of this subsection, the Secretary may require that a sponsor who, for reasons not satisfactory

to the Secretary, fails to complete by its deadline a study under any

of such sections of such type for a drug or biological product (including such a study conducted after such effective date) notify

practitioners who prescribe such drug or biological product of the

failure to complete such study and the questions of clinical benefit,

and, where appropriate, questions of safety, that remain unanswered as a result of the failure to complete such study. Nothing in

this subsection shall be construed as altering the requirements of

the types of studies required under section 506(b)(2)(A) or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as

so in effect, or as prohibiting the Secretary from modifying such sections of title 21 of such Code to provide for studies in addition to

those of such type.’’.

SEC. 507. SAVINGS CLAUSE.

Notwithstanding section 107 of the Food and Drug Administration Modernization Act of 1997, and notwithstanding the amendments made by this subtitle, part 2 of subchapter C of chapter VII

of the Federal Food, Drug, and Cosmetic Act, as in effect on the day

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before the date of the enactment of this Act, continues to be in effect

with respect to human drug applications and supplements (as defined in such part as of such day) that, on or after October 1, 1997,

but before October 1, 2002, were accepted by the Food and Drug Administration for filing.

SEC. 508. EFFECTIVE DATE.

The amendments made by this subtitle shall take effect October

1, 2002.

SEC. 509. SUNSET CLAUSE.

The amendments made by sections 503 and 504 cease to be effective October 1, 2007, and section 505 ceases to be effective 120

days after such date.

Subtitle B—Funding Provisions Regarding

Food and Drug Administration

SEC. 521. OFFICE OF DRUG SAFETY.

Of the amounts appropriated for the Food and Drug Administration for a fiscal year, the Secretary of Health and Human Services shall reserve for the Office of Drug Safety (within such Administration), the following amounts:

(1) For fiscal year 2003, an amount equal to the sum of $5,000,000 and the amount made available under appropriations Acts for such Office for fiscal year 2002.

(2) For fiscal year 2004, an amount equal to the sum of $10,000,000 and the amount made available under appropriations Acts for such Office for fiscal year 2002.

(3) For each subsequent fiscal year, an amount equal to the

sum of the amount made available under appropriations Acts

for such Office for fiscal year 2004 and an amount sufficient to

offset the effects of inflation occurring after the beginning of fiscal year 2004.

SEC. 522. DIVISION OF DRUG MARKETING, ADVERTISING, AND COMMUNICATIONS.

For the Division of Drug Marketing, Advertising, and Communications (within the Office of Medical Policy, Food and Drug Administration), there are authorized to be appropriated the following

amounts, stated as increases above the amount made available

under appropriations Acts for such Division for fiscal year 2002: (1) For fiscal year 2003, an increase of $2,500,000.

(2) For fiscal year 2004, an increase of $4,000,000.

(3) For fiscal year 2005, an increase of $5,500,000.

(4) For fiscal year 2006, an increase of $7,500,000.

(5) For fiscal year 2007, an increase of $7,500,000.

SEC. 523. OFFICE OF GENERIC DRUGS.

For the Office of Generic Drugs (within the Food and Drug Administration), there are authorized to be appropriated the following

amounts, stated as increases above the amount made available

under appropriations Acts for such Office for fiscal year 2002: (1) For fiscal year 2003, an increase of $3,000,000.

(2) For fiscal year 2004, an increase of $6,000,000.

(3) For fiscal year 2005, an increase of $9,000,000.

(4) For fiscal year 2006, an increase of $12,000,000.

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(5) For fiscal year 2007, an increase of $15,000,000.

Subtitle C—Additional Provisions

SEC. 531. TRANSITION TO DIGITAL TELEVISION.

(a) PAIR ASSIGNMENT REQUIRED.—In order to further promote

the orderly transition to digital television, and to promote the equitable allocation and use of digital channels by television broadcast

permittees and licensees, the Federal Communications Commission,

at the request of an eligible licensee or permittee, shall, within 90

days after the date of enactment of this Act, allot, if necessary, and

assign a paired digital television channel to that licensee or permittee, provided that—

(1) such channel can be allotted and assigned without further modification of the tables of allotments as set forth in sections 73.606 and 73.622 of the Commission’s regulations (47

CFR 73.606, 73.622); and

(2) such allotment and assignment is otherwise consistent

with the Commission’s rules (47 CFR part 73).

(b) ELIGIBLE TRANSITION LICENSEE OR PERMITTEE.—For purposes of subsection (a), the term ‘‘eligible licensee or permittee’’

means only a full power television broadcast licensee or permittee

(or its successor in interest) that—

(1) had an application pending for an analog television station construction permit as of October 24, 1991, which application was granted after April 3, 1997; and

(2) as of the date of enactment of this Act, is the permittee

or licensee of that station.

(c) REQUIREMENTS ON LICENSEE OR PERMITTEE.—

(1) CONSTRUCTION DEADLINE.—Any licensee or permittee receiving a paired digital channel pursuant to this section—

(A) shall be required to construct the digital television

broadcast facility within 18 months of the date on which

the Federal Communications Commission issues a construction permit therefore, and

(B) shall be prohibited from obtaining or receiving an

extension of time from the Commission beyond the construction deadline established by paragraph (1).

(2) PROHIBITION OF ANALOG OPERATION USING DIGITAL

PAIR.— Any licensee or permittee receiving a paired digital

channel pursuant to this section shall be prohibited from giving

up its current paired analog assignment and becoming a singlechannel broadcaster and operating in analog on such paired

digital channel.

(d) RELIEF RESTRICTED.—Any paired digital allotment and assignment made under this section shall not be available to any

other applicant unless such applicant is an eligible licensee or permittee within the meaning of subsection (b).

SEC. 532. 3-YEAR DELAY IN LOCK IN PROCEDURES FOR

MEDICARE+CHOICE PLANS; CHANGE IN CERTAIN

MEDICARE+CHOICE DEADLINES AND ANNUAL, COORDINATED ELECTION PERIOD FOR 2003, 2004, AND 2005.

(a) LOCK-IN DELAY.—Section 1851(e) of the Social Security Act

(42 U.S.C. 1395w–21(e)) is amended—

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(1) in paragraph (2)(A), by striking ‘‘THROUGH 2001’’ and ‘‘during 1998, 1999, 2000, and 2001’’ and inserting ‘‘THROUGH

2004’’ and ‘‘during the period beginning January 1, 1998, and

ending on December 31, 2004’’, respectively;

(2) in the heading to paragraph (2)(B), by striking ‘‘DURING

2002’’ and inserting ‘‘DURING 2005’’;

(3) in paragraphs (2)(B)(i) and (2)(C)(i), by striking ‘‘2002’’ and inserting ‘‘2005’’ each place it appears;

(4) in paragraph (2)(D), by striking ‘‘2001’’ and inserting ‘‘2004’’; and

(5) in paragraph (4), by striking ‘‘2002’’ and inserting ‘‘2005’’ each place it appears.

(b) CHANGE IN REPORTING DEADLINE.— (1) IN GENERAL.—Section 1854(a)(1) of such Act (42 U.S.C.

1395w–24(a)(1)) is amended by striking ‘‘Not later than July 1

of each year’’ and inserting ‘‘Not later than the second Monday

in September of 2002, 2003, and 2004 (or July 1 of each other

year)’’.

(2) EFFECTIVE DATE.—The amendment made by paragraph

(1) shall apply to information submitted for years beginning

with 2003.

(c) DELAY IN ANNUAL, COORDINATED ELECTION PERIOD.— (1) IN GENERAL.—Section 1851(e) of such Act (42 U.S.C.

1395w–21(e)) is amended— (A) in paragraph (3)(B), by striking ‘‘means’’ and all

that follows and inserting the following: ‘‘means, with respect to a year before 2003 and after 2005, the month of

November before such year and with respect to 2003, 2004,

and 2005, the period beginning on November 15 and ending on December 31 of the year before such year.’’; and

(B) in paragraph (6)(A), by striking ‘‘each subsequent

year (as provided in paragraph (3))’’ and inserting ‘‘during

the annual, coordinated election period under paragraph

(3) for each subsequent year’’. (2) EFFECTIVE DATE.—The amendment made by paragraph

(1) shall apply to the annual, coordinated election period for

years beginning with 2003.

(d) CHANGE TO ANNUAL ANNOUNCEMENT OF PAYMENT RATES.— (1) IN GENERAL.—Section 1853(b)(1) of such Act (42 U.S.C.

1395w–23(b)(1)) is amended by striking ‘‘not later than March

1 before the calendar year concerned’’ and inserting ‘‘for years

before 2004 and after 2005 not later than March 1 before the

calendar year concerned and for 2004 and 2005 not later than

the second Monday in May before the respective calendar year’’.

(2) EFFECTIVE DATE.—The amendment made by paragraph

(1) shall first apply to announcements for years after 2003.

And the Senate agree to the same.

From the Committee on Energy and Commerce, for consideration of the House bill and the Senate amendment, and

modifications committed to conference:

BILLY TAUZIN,

MICHAEL BILIRAKIS,

PAUL E. GILLMOR,

RICHARD BURR,

JOHN SHIMKUS,

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JOHN D. DINGELL, HENRY A. WAXMAN, SHERROD BROWN, Provided that Mr. Pallone is appointed in lieu of Mr.

Brown of Ohio for consideration of title IV of the House

bill, and modifications committed to conference:

FRANK PALLONE, Jr.,

From the Committee on Agriculture, for consideration of

title II of the House bill and sec. 216 and title V of the

Senate amendment, and modifications committed to conference:

LARRY COMBEST, FRANK D. LUCAS, SAXBY CHAMBLISS, CHARLES STENHOLM, TIM HOLDEN, From the Committee on the Judiciary, for consideration of

title II of the House bill and secs. 216 and 401 of the Senate amendment, and modifications committed to conference:

F. JAMES SENSENBRENNER, Jr.,

LAMAR SMITH, JOHN CONYERS, Jr.,

Managers on the Part of the House.

EDWARD KENNEDY,

CHRIS DODD,

TOM HARKIN,

BARBARA A. MIKULSKI,

JIM JEFFORDS,

JUDD GREGG,

BILL FRIST,

MIKE ENZI,

TIM HUTCHINSON,

Managers on the Part of the Senate.

(107)

JOINT EXPLANATORY STATEMENT OF THE COMMITTEE OF

CONFERENCE

The managers on the part of the House and the Senate at the

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, submit the following joint statement to the House and the Senate in explanation

of the effect of the action agreed upon by the managers and recommended in the accompanying conference report:

The Senate amendment struck all of the House bill after the

enacting clause and inserted a substitute text.

The House recedes from its disagreement to the amendment of

the Senate with an amendment that is a substitute for the House

bill and the Senate amendment. The differences between the House

bill, the Senate amendment, and the substitute agreed to in conference are noted below, except for clerical corrections, conforming

changes made necessary by agreements reached by the conferees,

and minor drafting and clerical changes.

TITLE I—NATIONAL PREPAREDNESS FOR BIOTERRORISM

AND OTHER PUBLIC HEALTH EMERGENCIES

As approved by the conference Managers, Title I addresses core

public health concerns associated with preparedness for and effective response to bioterrorism and other public health emergencies

in a number of different ways. First Title I improves communications between and among all levels of government, public health officials, first responders, and health care providers and facilities

during emergencies. The Managers have authorized substantial

sums in FY 2002 and beyond in grants to States, local governments, and other public and private health care facilities and other

entities to improve planning and preparedness activities, and educate and train health care personnel. Under Title I, the Department of Health and Human Services (HHS) will have a new focus,

and improved coordination and accountability, through a new Assistant Secretary for Public Health Emergency Preparedness. The

legislation also authorizes the National Disaster Medical System,

new planning and reporting provisions, training exercises, and improved communications strategies and networks. The Managers

also believe that the provisions of Title I will ensure that the nation has sufficient drugs, vaccines, and other supplies for our emergency health security. The Managers intend for activities under

Title I to enhance the Nation’s public health infrastructure at the

national, state, and local levels. The Managers believe that an effective public health system is essential to responding effectively to

bioterrorism and other public health emergencies.

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Subtitle A—National Preparedness and Response Planning,

Coordinating, and Reporting

Section 101. National Preparedness and Response

House provision: The House provision requires the Secretary of

HHS to continue the process of developing and implementing a coordinated strategy, including the preparation of a national plan for

carrying out health-related activities to prepare for and respond effectively to bioterrorism and other public health emergencies. The

plan would be in consultation with other Federal agencies and

other appropriate public and private entities. The plan also would

be coordinated with activities of State and local governments to

meet preparedness goals set out under the Act. National preparedness goals include providing effective assistance to State and local

governments to ensure that they and their health care facilities

have adequate capacity and properly trained response personnel; a

coordinated plan, effective communications networks, and laboratory readiness, training and surveillance; developing and maintaining medical countermeasures against biological agents; and effective coordination at all levels of government. There would be evaluations and reports of progress.

Senate amendment: The Senate amendment contains similar

provisions.

Conference substitute: The Conference adopts the House provisions with certain modifications to clarify the provision does not expand regulatory or other authority, and to incorporate various advisory committee and study provisions. A study to emergency response services and their use during public health emergencies, formerly located in section 114 of the House bill, is now located in this

section.

Section 102. Assistant Secretary for Public Health Emergency Preparedness; National Disaster Medical System

House provision: The House provision establishes the new position of Assistant Secretary for Emergency Preparedness to coordinate HHS activities under the new Act. The provision also would

authorize the National Disaster Medical System, under the new

Assistant Secretary to provide for further National capacity during

public health emergencies.

Senate amendment: The Senate amendment contains a similar

provision in section 211 of the Senate amendment.

Conference substitute: The Conference substitute uses the

House language with modification. The Managers believe that

there is a need to increase coordination of the Department of

Health and Human Services’ efforts in responding to bioterrorism

and other public health emergencies, and thus has provided for the

creation of an Assistant Secretary for Public Health Emergency

Preparedness. The substitute also formally establishes the National

Disaster Medical System (NDMS), recognizing the important role

already played by the NDMS in the Federal government’s response

to all types of emergencies and disasters. The substitute also addresses a number of critical personnel issues within the NDMS, including liability protections, employment rights, and compensation

for work injuries. In addition, the Secretary shall take into account

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the role and expertise of the Agency for Toxic Substances and Disease Registry.

Section 103. Improving Ability of Centers for Disease Control and

Prevention

House provision: The House bill provides authorization and

multi-year contracting authority for the renovation, development

and security at facilities for the Centers for Disease Control and

Prevention (CDC). The House bill also enhances training and nationwide laboratory capacity, and the establishment of integrated,

national public health communications and surveillance networks.

Senate amendment: The Senate amendment, in section 202,

also contains provisions for upgrading CDC’s activities and facilities.

Conference substitute: The Conference substitute adopts the

House provision with modifications. The substitute recognizes the

critical role played by CDC in the nation’s efforts to defend against

bioterrorism and other public health emergencies. The Managers

are concerned by extreme disrepair at many CDC laboratories and

believe that repair and modernization funds are desperately needed. To that end, the substitute has provided multi-year contracting

authority for CDC and has authorized an accelerated program of

facilities funding. The substitute also recognizes the central role

played by CDC in maintaining robust public health alert communications and surveillance networks, and has provided for grants,

contracts, and cooperative agreements to further strengthen a national network that includes public health laboratories and other

health care facilities. Provisions concerning priorities for public

health lab enhancements have been moved to the general grants

section, section 131, of the Conference substitute.

Section 104. Advisory Committees and Communications; Study Regarding Communications Abilities of Public Health Agencies

House provision: Section 104 of the House bill establishes an

advisory committee on children and terrorism and also one on

emergency public information and communications. The provision

also requires a coordinated strategy on public health communications during a bioterrorism attack. Section 111 also contains a provision for a study regarding the communications ability of public

health agencies and to improve telecommunications infrastructure

and connectivity during public health emergencies.

Senate amendment: Section 213 of the Senate amendment contains similar provisions. Section 214 of the Senate amendment also

contains a provision establishing the official Federal Internet Site

on Bioterrorism.

Conference substitute: The Conference substitute adopts, with

minor modification, the provisions from the House and Senate establishing an advisory committee on children and terrorism; an advisory committee on emergency public information and communications; a coordinated strategy on public health communications during a bioterrorism attack; and the official Federal Internet Site on

Bioterrorism.

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Section 105. Education of Health Care Personnel; Training Regarding Pediatric Issues

House provision: The House bill requires the establishment of

core curriculum materials for public health emergencies, for the

purpose of education and training of health care personnel.

Senate amendment: Section 105 of the Senate amendment contains a similar provision.

Conference substitute: The Conference substitute adopts the

House provision with minor modification. The Managers intend

that the eligible entity phrase ‘‘other appropriate educational entities’’ includes medical schools that have established departments of

medical education.

Section 106. Grants Regarding Shortages of Certain Health Professionals

House provision: The House bill provides grants for training

and education to certain categories of health care professionals for

which there exist shortages impacting the ability to respond to bioterrorism and other public health emergencies.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference adopts the House provision without modification.

Section 107. Emergency System for Advance Registration of Health

Professions Volunteers

House provision: The House bill establishes a national system

to help verify the licenses, credentials and hospital privileges of

health professionals who volunteer to respond during public health

emergencies.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference adopts the House provision with modifications to make clear that use of the verification

database is entirely voluntary, and that nothing in the section

changes the roles of States in licensing or hospitals in establishing

privileging requirements.

Section 108. Working Groups

House provision: House section 108 makes modifications to the

existing working groups in section 319 of the Public Health Service

Act (PHSA).

Senate amendment: The Senate amendment also makes modifications and additions to the working group provisions. The Senate

amendment also consolidates the two existing working groups in

sections 319F of the Public Health Service Act.

Conference substitute: The Conference substitute adopts a single working group, but allows for subcommittees to represent the

working group with respect to particular matters. The authority of

the working group is limited through various savings clauses. The

primary purposes of the working group are consultation, assisting

in coordination, and making recommendations on a variety of topics related to preparedness for and response to bioterrorism and

other public health emergencies. The Managers expect the working

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group to take into account the role and expertise of the Agency for

Toxic Substances and Disease Registry. Additionally, the Managers

encourage the working group to recognize the role of private ambulance services, especially when they may be the only ambulance

services in the area.

Section 109. Antimicrobial Resistance

House provision: The House bill authorizes further research

and DNA analysis of priority pathogens that may be used by bioterrorists, and contains other provisions concerning antimicrobial

resistance.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House provision on antimicrobial resistance. The provision concerning priority pathogens has been moved to section 125 of the

Conference substitute.

Section 110. Supplies and Services in Lieu of Award Funds

House provision: The House bill provides flexibility to allow the

Secretary of HHS to supply actual supplies, equipment, or services

instead of, or in conjunction with, grants.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House provision.

Section 111. Additional Amendments

House provision: The House bill makes revisions to time

frames to accelerate preparedness planning.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House provision.

Subtitle B—Strategic National Stockpile; Development of Priority

Countermeasures

Section 121. Strategic National Stockpile

House provision: The House bill authorizes a national stockpile

or stockpiles of drugs, vaccines, biologic products, medical devices

and supplies to meet the health security needs of the United

States. It requires enhanced procedures for coordination, maintenance, delivery, and distribution. House authorization language in

section 151 of the House bill specifies specific sums for smallpox

vaccines.

Senate amendment: Section 201 of the Senate amendment also

authorizes a national stockpile, and separately has a provision

under section 402 for authorizing smallpox vaccines for the stockpile.

Conference substitute: The Conference substitute adopts the

House provision with modifications and inclusion of a specific provision on smallpox vaccines. The Managers believe that antiviral

products may be appropriate for the strategic national stockpile

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and may include antiviral products reviewed by the Food and Drug

Administration (FDA) or National Institutes of Health (NIH).

Section 122. Accelerated Approval of Priority Countermeasures

House provision: The House bill clarifies certain fast-track authority for drug priority countermeasures under the Federal Food,

Drug, and Cosmetic Act.

Senate amendment: Section 405 of the Senate amendment contains a similar provision.

Conference substitute: The Conference substitute adopts the

Senate provision with modification.

Section 123. Issuance of Rule on Animal Trials

House provision: The House bill requires the FDA to issue a

final rule within six months allowing reliance on animal trials for

certain priority countermeasures for public health emergencies.

Senate amendment: The Senate amendment contains a similar

requirement with a 30-day time frame.

Conference substitute: The Conference substitute adopts the

House provision with modifications to provide the rule within 90

days of the date of enactment.

Section 124. Security for Countermeasure Development and Production

House provision: The House bill authorizes the Secretary, in

consultation with the Attorney General and Secretary of Defense,

to provide technical or other assistance to enhance security at facilities that conduct development, production, distribution, or storage of priority countermeasures.

Senate amendment: Section 402 of the Senate amendment contains a similar provision and also provides for best practices guidelines.

Conference substitute: The Conference substitute adopts the

House provisions without a requirement for best practices guidelines.

Section 125. Accelerated Countermeasure Research and Development

House provision: The House bill directs the Secretary to conduct an accelerated countermeasure development program, and to

award grants for biomedical research, development of vaccines, and

diagnostic tests for priority countermeasures.

Senate amendment: Section 404 of the Senate amendment contains similar provisions.

Conference substitute: The Conference substitute adopts the

Senate provisions with modifications. The House provision concerning priority pathogens is included. The Managers encourage

the Secretary to consider novel methods for detecting and identifying viral and bacterial pathogens, and developing and manufacturing effective therapeutic responses, including both vaccines and

antibiotics. The Managers also encourage the Secretary to consider

the use of emerging biophysical and biomanufacturing technologies

that hold the promise of producing rapid detection/response programs that can achieve accelerated responses to bioterrist attacks

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or threats. In addition, the Managers encourage the Secretary, in

coordination with the Administrator of the Environmental Protection Agency, to develop protocols for and enhance facilities for testing technologies used to decontaminate facilities contaminated as a

result of bioterrorism.

Section 126. Evaluation of New and Emerging Technologies Regarding Bioterrist Attack and Other Public Health Emergencies

House provision: The House bill requires the Secretary to

evaluate new and emerging technologies to help detect, identify, diagnose, or conduct public health surveillance activities for public

health emergencies, and prioritize development and deployment

where warranted.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House provision with limiting modifications.

Section 127. Potassium Iodide

House provision: The House bill requires the Secretary to make

potassium iodide available to States and local governments that

submit a plan for local stockpile and distribution for the population

within 20 miles of a nuclear power plant.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House provision with modifications that include authority provided

to the President; additional restrictions on the eligibility of local

governments; and a different schedule for effective dates, and other

modifications.

Subtitle C—Improving State, Local, and Hospital Preparedness for

and Response to Bioterrorism and Other Public Health Emergencies

Section 131. Grants to Improve State, Local, and Hospital Preparedness for and Response to Bioterrorism and Other Public

Health Emergencies

House provision: The House bill modifies current authorities

under section 319 of the PHSA and otherwise authorized grant

funding to improve State, local, and hospital preparedness for and

response to bioterrorism and other public health emergencies

through the existing mechanisms of the PHSA. Authorization was

provided from FY 2002–2006.

Senate amendment: The Senate amendment contains a provision for State block grants for fiscal years 2002–2003 for bioterrorism activities only, and the authorization would not continue

past FY 2003. It also provides an authorization for bioterrorism

medical centers with authorization from FY 2002–2006, limited to

bioterrorism activities. Finally, the Senate amendment maintains

and authorizes a portion of funding under section 319 for a broader

list of purposes and eligible entities.

Conference substitute: The Conference substitute reflects a

compromise between House and Senate approaches. For FY 2003,

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there is a modified State block grant provision. Beyond FY 2003,

greater flexibility is provided to the Secretary to either continue

the same approach or modify the approach without the restrictions

of the FY 2003 formulas. The substitute also provides authorization

for the purpose of enhancing the preparedness of hospitals (including children’s hospitals), clinics, health centers, and primary care

facilities, and for planning and administrative purposes relating to

such authorizations. For FY 2004–2006, there is a new section 319

C–2.

The Managers want to ensure that section 131 does not delay

or disrupt the current grants and cooperative agreements that the

Administration has been using in FY 2002, including those programs administered by CDC and the Health Resources and Services Administration (HRSA). It is the Managers’ intent to allow the

Administration to continue this approach. The Managers expect the

Administration to evaluate the effectiveness of the program and

make revisions where necessary to improve effectiveness and accountability.

The Managers intend that a permissible use of funds under

this section includes grants to one or more centers of excellence to

develop appropriate innovative technology projects—for example,

the development of a web-based computerized planning application

that incorporates standardized language and utilizes wireless mobile technology. The Managers intend that training programs pursuant to this section could include the use of virtual reality training methods, human patient simulators, computer-assisted training

modalities, and internet-based training and modeling capabilities.

One or more centers of excellence could be established to develop,

deploy, and evaluate virtual and augmented reality-based, internetready training capabilities.

Subtitle D—Emergency Authorities; Additional Provisions

Section 141. Reporting Deadlines

House provision: The House bill provides extensions for certain

reporting deadlines during a public health emergency, and for

transfer authority for funds during a public health emergency.

Senate amendment: The Senate amendment contains an analogous provision on reporting deadlines and no new transfer authority.

Conference substitute: The Conference substitute adopts the

Senate provision on reporting deadlines with minor modifications.

Section 142. Streamlining and Clarifying Communicable Disease

Quarantine Provisions

House provision: The House bill changes existing law to expand

the authority of the Secretary, in consultation with the Surgeon

General, and under certain conditions, to specify diseases that are

subject to individual detention orders.

Senate amendment: The senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House provision with modifications to the standards required before the Secretary may exercise this authority.

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Section 143. Emergency Waiver of Medicare, Medicaid, and SCHIP

Requirements

House provision: Section 143 allows the Secretary of Health

and Human Services to waive certain requirements (and related

regulations) in of titles XVIII, XIX, and XXI of the Social Security

Act (as well as requirements and regulations under title XI of the

Social Security Act, only as necessary to effectuate the waiver of

the enumerated requirements of titles XVIII, XIX, and XXI to meet

the purposes of this section) in the event of an emergency or disaster in order to: (1) facilitate the provision of health services in

the emergency or disaster area, and (2) ensure that health care

providers who furnish care in good faith to individuals enrolled in

these programs during an emergency or disaster may be reimbursed without penalty. The Secretary can waive requirements pertaining to: conditions of participation for providers; provider licensing requirements; sanctions for physician self-referral; sanctions relating to transferring patients in an emergency; and deadlines for

filing reports for periods of up to 90 days.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House provision with modifications. The Managers agree that the

Secretary shall provide written notice to Congress, including a certification that a waiver is necessary. This notice shall be issued before the waiver authority is exercised. Additionally, the Secretary

must report to Congress within a year evaluating the effectiveness

of the approaches used during the operation of the waiver. The

time frame for such waivers shall be 60 days.

Section 144. Provision for Expiration of Public Health Emergencies

House provision: The House bill provides that public health

emergencies expire by announcement of the Secretary, or after 90

days. The Secretary may renew emergency declarations at his or

her discretion.

Senate amendment: Section 212 of the Senate Amendment contains a similar provision, but with a 180-day expiration period.

Conference substitute: The Conference substitute adopts the

House provision with amendments, including clarifying the status

of any existing declaration of public health emergencies.

Subtitle—Additional Provisions

Section 151. Designated State Public Emergency Announcement

Plan

House provision: Section 135 of the House bill amends the Stafford Act to provide for coordinated communications response.

Senate amendment: Section 312 of the Senate amendment contains an identical provision.

Conference substitute: The Conference substitute adopts the

identical House and Senate provisions.

Section 152. Expanded Research by Secretary of Energy

House provision: The House bill expands current research at

the Department of Energy (DOE) and the National Nuclear SecuVerDate 11-MAY-2000 07:55 May 23, 2002 Jkt 099006 PO 00000 Frm 00119 Fmt 6604 Sfmt 6601 E:\HR\OC\HR481.XXX pfrm09 PsN: HR481
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rity Administration (NNSA) on rapid detection of pathogens likely

to be used in bioterrorist attacks or other agents that may cause

a public health emergency.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House provision.

Section 153. Expanded Research on Worker Health and Safety

House provision: The House bill authorizes the National Institutes of Occupational Safety and Health (NIOSH) to expand research on health and safety of workers who are at risk for bioterrorist threats or attacks in the workplace.

Senate amendment: The Senate amendment contains an analogous provision.

Conference substitute: The Conference substitute adopts the

Senate Amendment with minor modification.

Section 154. Enhancement of Emergency Preparedness of Department of Veterans Affairs

House provision: The House bill has no analogous provision.

Senate amendment: The Senate amendment has no analogous

provision.

Conference substitute: The Conference substitute instructs the

Secretary of Veterans Affairs to take appropriate actions to enhance the readiness of the Department’s medical centers and research facilities for a chemical or biological attack, based on the results of an evaluation to be conducted by the Secretary on the security needs at these facilities.

Section 155. Reauthorization of Existing Program

House provision: The House bill has no analogous provision.

Senate amendment: The Senate amendment has no analogous

provision.

Conference substitute: The Conference substitute amends section 582(f) of the Public Health Service Act by reauthorizing a

grant program through 2006 that provides awards to public and

private entities, as well as Indian tribes and tribal organizations,

that develop programs focusing on the behavioral and biological aspects of psychological trauma response and research that will help

treat psychiatric disorders of children and youth resulting from

witnessing or experiencing a traumatic event.

Section 156. Sense of Congress

House provision: The House bill has no analogous provision.

Senate amendment: The Senate amendment states that Congress recognizes that many university-based programs are already

functioning and developing important biodefense products and solutions. Congress should recognize the importance of supporting work

done at university centers and laboratories. In addition, Congress

should recognize the importance of existing public and private university-based research, training, public awareness, and safety-related biological defense programs in the awarding of grants and

contracts made in accordance with this Act.

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Conference substitute: The Conference substitute contains one

modification to the Senate amendment, which clarifies that the

Secretary of Health and Human Services may recognize the importance of existing public and private university-based efforts in

grants and cooperative agreements.

Section 157. General Accounting Office Report

House provision: The House bill has no analogous provision.

Senate amendment: The Senate amendment requires a General

Accounting Office (GAO) report to Congress on Federal bioterrorism-related activities.

Conference substitute: The Conference substitute amends section 319F of the Public Health Service Act to require GAO to report

on Federal bioterrorism-related activities, including research, preparedness, and response, to the following committees: Senate

Health, Education, Labor, and Pensions; Senate Appropriations;

House Energy and Commerce; and House Appropriations.

Section 158. Certain Awards

House provision: The House bill has no analogous provision.

Senate amendment: The Senate amendment has no analogous

provision.

Conference substitute: The Conference substitute amends section 319(a) of the Public Health Service Act by inserting after

‘‘grants,’’ ‘‘providing awards for expenses, and.’’

Section 159. Public Access Defibrillation Programs and Public Access Defibrillation Demonstration Projects

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute amends section 243 of title 42, United States Code, to enact the ‘‘Community

Access to Emergency Defibrillation Act of 2002.’’ The Conference

substitute directs the Secretary to establish a new grant program

for States, political subdivisions of States, Indian tribes, and tribal

organizations to develop and implement public access defibrillation

programs. These grants may be used to purchase automated external defibrillators (AEDs), to provide automated external

defibrillation and basic life support training in AED usage, to provide information to community members about the public access

defibrillation program, to provide information to the local emergency medical system regarding the placement of AEDs, and to

produce materials to encourage private companies to purchase

AEDs. For this new grant program, the Conference substitute authorizes the appropriation of $25 million in fiscal year 2002, and

such sums as may be necessary for each of the fiscal years 2004

through 2006. The Conference substitute also establishes a new

grant program for political divisions of States, Indian tribes, and

tribal organizations to develop and implement innovative, comprehensive, community-based public access defibrillation demonstration projects. These grants may be used to purchase AEDs,

to provide basic life training in automated external defibrillator

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usage, to provide information to community members about the

public access defibrillation demonstration project, and to provide

information to the local emergency medical services system regarding the placement of AEDs. For these demonstration projects, the

Conference substitute authorizes the appropriation of $5 million for

fiscal years 2003 through 2006. The Managers intend that the

‘‘Good Samaritan’’ protections regarding emergency use of AEDs

outlined in section 238(q) of title 42, United States Code will apply

to this section. It is the intent of the Managers that this new program coordinates its activities with the Rural AED program and

avoid duplication of effort.

TITLE II—ENHANCING CONTROLS ON DANGEROUS

BIOLOGICAL AGENTS AND TOXINS

Subtitle A—Department of Health and Human Services

Section 201. Regulation of Certain Biological Agents and Toxins

House provision: The House bill requires all persons who possess, use or transfer ‘‘select agents’’—the 36 biological agents or

toxins currently determined by the Secretary of the Department of

Health and Human Services (HHS) to pose ‘‘a severe threat to public health and safety’’—to register with the Secretary and be subject to reasonable safety and security requirements and inspections.

Current law requires registration only of those entities transferring

such agents. The House bill also directs that the Secretary maintain a national database of all such agents, with sufficient information to facilitate their identification and traceability. The Secretary,

in consultation with the Attorney General, must establish specific

security requirements for registered facilities and a personnel

screening protocol to ensure that access to such agents is not permitted by individuals who are ‘‘restricted persons’’ under the USA

PATRIOT Act (18 U.S.C. 175b), are named in a warrant for violent

criminal or terrorist activity, are under investigation for involvement in domestic or international terrorist or criminal organizations, or suspected of spying for the military or intelligence operations of a foreign nation. The Secretary is granted authority to assist public and nonprofit private entities in meeting such security

requirements. The House bill also imposes civil penalties for those

who violate the regulations, up to $500,000.

The House bill grants the Secretary discretion to make exemptions to the registration requirements only where those exemptions

are consistent with protecting the public health and safety—for example, with respect to inactivated or attenuated strains of select

agents used in vaccines or other products for legitimate medical research or use—or when the agent is presented for diagnosis,

verification or proficiency testing purposes at a clinical laboratory

and is promptly destroyed or transferred to a registered facility

after such identification. The House bill also exempts from mandatory disclosure under the Freedom of Information Act (FOIA) sitespecific or identifying information submitted under these regulations concerning registered persons, select agents, and security

mechanisms.

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Senate amendment: The Senate amendment is substantially

similar to the House bill but differs in a few respects. First, in developing the list of select agents, the Secretary is directed to consider the needs of children and other vulnerable populations. Second, individuals who seek access to select agents are screened only

to identify if they are ‘‘restricted persons’’ under the USA PATRIOT Act, or are named in a warrant for participation in a domestic or international act of terrorism. Third, the Secretary is permitted to exempt certain attenuated or inactive biological agents or

toxins and certain approved medical products from the list of select

agents.

Conference substitute: The Conference substitute adopts provisions of both bills, with significant modifications. The primary

goals of this subtitle are to ensure the prompt reporting to the Federal government of possession of select agents (including by those

who were in possession prior to April 15, 1997, the effective date

for reporting transfers of select agents), to increase the security

over such agents (including access controls and screening of personnel), and to establish a comprehensive and detailed national

database of the location and characterization of such agents and

the identities of those in possession of them. To effectuate these

goals, the substitute requires that, at a minimum, all possession of

select agents (unless exempt under the provisions of this subtitle)

must be registered with the Secretary. The Managers expect that

most ‘‘persons’’ who register under this subtitle will be public and

private entities, rather than individuals. But these provisions also

will cover individuals possessing, using or transferring select

agents who have not been granted authority to do so by registered

persons. If an individual has not been granted such authority, then

that individual would be a person required to register under this

subtitle. If an individual has been granted such authority without

proper authorization from the Secretary, as required by this subtitle, then the registered person is subject to any penalties provided

for violation of such regulations. The Managers emphasize that the

primary responsibility for registration and the screening of employees working with select agents is with the entity or employer, not

the individual employee. The Secretary also is required to promulgate regulations establishing safety requirements for the possession, use, and transfer of select agents. These regulations must include procedures to protect the public safety in the event the safety

requirements for possession, use or transfer are violated.

The Managers recognize that some select agents may pose a

greater threat to the public health and safety than others. Accordingly, the Conference substitute amends the security requirements

of both bills by adding the phrase ‘‘commensurate with the risk

such agent or toxin poses to public health and safety (including the

risk of use in domestic or international terrorism).’’ The Secretary

will have flexibility to impose different levels of security requirements on different select agents based on his or her evaluation of

the level of threat to the public, as is currently done with respect

to laboratory biosafety levels. Because an agent must pose a severe

threat to human health to be placed on the select agent list, the

Secretary may not decide that security requirements or registration

of possession are unnecessary for a particular select agent.

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The substitute also modifies the existing statutory requirements for the transfer regulations by adding ‘‘and security measures’’ after ‘‘safeguards’’ in the term ‘‘safeguards to prevent access

. . . for use in domestic or international terrorism or for any other

criminal purposes’’ to clarify that such regulations include the imposition of security requirements. The substitute also requires that

registered persons promptly notify the Secretary whenever a select

agent is lost, stolen, or released outside of a biocontainment area

of a facility. Current HHS regulations do not mandate such notifications.

The Conference substitute adds new provisions regarding the

screening of entities and individuals seeking to register their possession, use or transfer of select agents. While both the House and

Senate bills mandate screening of individuals seeking access to

agents through a registered person, neither bill required screening

of the registered persons themselves. The substitute provides for

such screening in a similar manner to that performed for individuals working at the facilities of registered persons. Further with respect to screening, the substitute drops the provision in both bills

relating to outstanding warrants, as duplicative of the fugitive provision in the restricted person categories of the USA PATRIOT Act,

and adds a screening category that was in neither bill—those reasonably suspected of committing Federal crimes of terrorism. The

substitute includes but makes revisions to the two additional

screening categories contained in the House bill to ensure an objective basis for governmental suspicion of involvement with terrorist

or criminal organizations, or with foreign powers. In the case of restricted persons, the substitute mandates that access to select

agents be denied, because of the criminal prohibition on possession

by such persons. In the case of persons falling within the other

three specified categories, the substitute grants the Secretary and

Attorney General discretion in determining how to proceed, given

the law enforcement sensitivity of such situations. By making this

distinction between the handling of restricted persons and other

screening categories, the Managers do not intend that potential terrorists or foreign agents should be subject to a less strict screening

standard than restricted persons. The substitute also clarifies that

the screening performed by the Attorney General is for the sole

purpose of identifying—through the use of official, electronic databases available to the Federal government—whether an individual

or entity falls within any of the specified categories, and for notifying the HHS Secretary of such identification. It is the Managers’

intent that the term ‘‘electronic databases’’ is not meant to preclude

the use of other databases or files by the Attorney General to clarify or confirm information obtained during the electronic database

search.

To address concerns within the academic and research communities about the timeliness and accuracy of the background screening process, the Conference substitute amends both bills by requiring ‘‘prompt’’ action by the Attorney General and the Secretary

with respect to screening of and notification to affected individuals,

and by providing for an expedited review process where good cause

has been demonstrated by the registered person. The substitute

also provides for a review of denials by the Secretary based on the

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screening process, and subsequent judicial review—with provisions

to ensure that classified or sensitive law enforcement information

is not compromised during such reviews. Specifically, the substitute

allows for ex parte review by the Secretary in administrative proceedings, and the court during judicial review, whenever a denial

is challenged. In providing the right for ex parte review, the Managers intend to protect classified and law enforcement sensitive information, including through the use of in camera proceedings.

Moreover, the Managers intend that a reviewing court should not

order the disclosure of any information that the United States believes may compromise national security or an ongoing law enforcement investigation without affording the United States an opportunity for further review in accordance with this subtitle. It is the

Managers’ overall expectation that the screening process be conducted in a timely and fair manner, and that the Secretary and the

Attorney General will work closely together to effectuate such intent.

With respect to the national database of select agents that the

Secretary must develop pursuant to this section, the Conference

substitute slightly alters the language used in both bills with respect to the database’s purpose. The object of the registration and

database requirements is to provide information about all persons

possessing, using or transferring select agents, and to collect sufficiently detailed characterization information on the registered select agents so that the database can differentiate between and

within strains of a given agent or toxin. Such information should

be in a format that public health and law enforcement officials can

use to identify the origin or source of an agent or toxin that is used

to cause harm to the public. Because of concerns over the potential

for misconstruction, the term ‘‘traceability’’—which could imply a

chain of custody or tracking requirement—was eliminated, and was

replaced with the concept of ‘‘source.’’

Significant modifications were made to both bills with respect

to exemptions from the statutory and regulatory requirements governing select agents. The Conference substitute establishes several

exemptions from the regulatory regime for select agents, most of

which are consistent with the Secretary’s current regulations and

practices. First, the Conference substitute adopts, with modifications, the Senate amendment’s language with respect to product

exemptions. The substitute directs the Secretary to exempt from

such regulations products that are, bear or contain a select agent

and are licensed or approved under several specified Federal laws,

unless the Secretary determines that additional regulation is necessary for a specific product to ensure protection of public health

and safety. The Managers intend that the Secretary will exempt by

regulation categories of products, consistent with current regulations, and will act to regulate a specific product, or a particular application of a specific product, only when existing regulation under

other Federal laws is inadequate. For example, HHS currently exempts the FDA-approved medical product Botox, which is the select

agent botulinum toxin, when it is used by licensed physicians in

the treatment of patients. However, when it is used in purely research settings or as part of early-stage clinical trials, HHS has

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chosen not to exempt Botox from current regulations. The Managers do not intend to alter this flexibility.

Second, the Conference substitute adds a provision granting

the Secretary discretionary authority to exempt, on a case-by-case

basis, investigational products when they are being used in investigational or clinical trials authorized under other Federal laws,

such as the Federal Food, Drug, and Cosmetic Act. Given the time

sensitivity of such trials, the substitute also includes a provision

mandating a prompt determination by the Secretary of such an exemption request—within 14 days after the applicant has submitted

a complete exemption request and has notified the Secretary that

the investigation may proceed as authorized under Federal law.

Third, with respect to clinical or diagnostic laboratories that

may come into possession of select agents when conducting specimen diagnosis, verification or proficiency testing, the substitute

adopts with minor changes the comparable provisions in the House

and Senate bills. The Secretary shall exempt such laboratories

from registration requirements, but only if they report the identification of select agents to the Secretary and either promptly transfer the agent to a registered person or destroy the agent on site,

in accordance with regulations established by the Secretary. While

HHS currently exempts such laboratories, existing regulations permit them to transfer, destroy, or store the agent on site for reference purposes. The Conference substitute expressly rejects that

regulatory approach, as it is inconsistent with the fundamental

premise of this title—that all those who maintain possession of a

select agent must register and be subject to appropriate security

and safety requirements. The Secretary may not exempt laboratories that possess select agents for reference purposes, or any

other clinical or diagnostic laboratories that do not qualify for an

exemption under the terms of this title. In addition, the Conference

substitute creates two temporary exemption authorities to deal

with public health emergencies and agricultural emergencies,

whether domestic or foreign.

With respect to funding, the Conference substitute authorizes

such sums as may be necessary to carry out these new and expanded functions. The Managers note that, historically, HHS has

had insufficient resources to properly run the existing select agent

transfer program. While current regulations permit inspections,

only 20 percent of all registered facilities have been inspected since

the inception of the program in 1997, and virtually none of these

inspections were conducted prior to registration. The Managers

also note that HHS received a large increase in funding for this

program in the Fiscal Year 2002 supplemental appropriations bill.

Given the broader, but uncertain scope of the new regulatory regime, it is unclear whether additional funds beyond current appropriations will be necessary for Fiscal Year 2003. Once all persons

possessing select agents notify the Secretary of such possession 90

days after enactment of this title, the appropriations level may

need to be re-evaluated.

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Section 202. Implementation by Department of Health and Human

Services

House provision: The House bill requires notification to the

Secretary by all persons possessing select agents within 60 days of

enactment, and an interim final rule establishing a regulatory

structure to be issued within 120 days of enactment.

Senate amendment: The Senate amendment requires the Secretary to issue an interim final rule within 180 days of enactment,

and requires all persons possessing select agents to register within

60 days of issuance of the rule.

Conference substitute: The Conference substitute adopts the

House bill with modifications. The substitute requires notification

to the Secretary by all persons possessing select agents within 90

days of enactment, based on guidance issued by the Secretary within 30 days of enactment, and the issuance of an interim final rule

within 180 days of enactment. The substitute also provides that the

interim final rule shall include time frames for applicability of the

rule that minimize disruption of research or educational projects

that involve select agents and that were underway as of the effective date of such rule. The Managers note that the interim final

rule and effective date provisions will result in these new regulations going into effect at approximately the same time as the National Institutes of Health (NIH) begins to award Fiscal Year 2003

grants for research, some of which will be in the select agent area.

The Managers expect that the Secretary will encourage those seeking such grants to begin the registration and screening process

under this title concurrently with the NIH grant process, and that

the Secretary will ensure the timely registration and screening of

such grantees, so as not to delay this important research.

Section 203. Effective Dates

House provision and Senate amendment: Both the House bill

and the Senate amendment provide that regulations promulgated

by the Secretary under section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 are deemed to have been promulgated under section 351A of the Public Health Service Act, as

added by this Act. They both also provide that the FOIA exemptions apply retroactively to the effective date of the Antiterrorism

and Effective Death Penalty Act of 1996.

Conference substitute: The Conference substitute adopts the

same provisions.

Section 204. Conforming Amendment

House provision and Senate amendment: Both the House bill

and the Senate amendment repeal those provisions of the

Antiterrorism and Effective Death Penalty Act of 1996 that have

been codified in section 351A of the Public Health Service Act by

this Act.

Conference substitute: The Conference substitute adopts the

same provisions.

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Subtitle B—Department of Agriculture

Section 211. Short Title

House provision and Senate amendment: Neither the House bill

nor the Senate amendment contain any analogous provision.

Conference substitute: The Conference substitute includes a

new subtitle, with its own short title—the Agricultural Bioterrorism Protection Act of 2002.

Section 212. Regulation of Certain Biological Agents and Toxins

House provision and Senate amendment: Neither the House bill

nor the Senate amendment contain any analogous provision.

Conference substitute: The Conference substitute adopts provisions that would grant comparable regulatory authorities to the

U.S. Department of Agriculture (USDA) as those granted to HHS

under subtitle A of this title for the regulation of possession, use

or transfer of listed biological agents and toxins that present a severe threat to plant or animal health, or animal or plant products.

In an effort to minimize regulatory duplication and burden, the

substitute seeks to ensure, to the greatest extent practicable, uniformity in the statutory authority that the two departments will

administer. Exceptions exist in the criteria to be used by the Secretary of Agriculture in developing a list of agriculturally significant biological agents and toxins; considerations to be made in

granting exemptions from regulation under the statute; procedures

related to civil monetary penalties; and the time frames for promulgation of a biological agents and toxins list and the accompanying

requirement that individuals who possess these agents notify the

Secretary of such possession. In addition, with respect to the

screening of persons registering or accessing listed agents, the substitute uses the same screening categories as are in subtitle A, but

does not mandate any denials of access, given that possession of

USDA-listed agents by restricted persons is not a Federal crime.

Instead, the Secretary and Attorney General are granted discretion

as to how to proceed in such situations.

The Managers recognize that, under provisions of current law,

biologics manufacturers have had to register, maintain associated

paperwork, and be subject to inspections and requirements from

both USDA and HHS. Likewise, the Managers are aware that the

inadequacy of the penalty provisions of the Virus-Serum-Toxin

Act—enacted in 1913 and under which USDA currently regulates

these dangerous agents—as well as the lack of authority for the

Secretary of Agriculture to regulate possession of biological agents

and toxins that pose a severe threat to plant or animal health may

expose the United States to potential acts of bioterrorism that

could have a devastating impact on animal and plant health, or the

domestic agricultural economy.

The Managers intend that, in developing the list of agents and

toxins to be regulated under this subtitle, the USDA Secretary

shall consult with other appropriate Federal agencies. With regard

to zoonotic agents, which pose a threat to both animals and humans, the Managers expect that the USDA Secretary will consult

with the HHS Secretary in developing such a list. The Managers

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lated agents and toxins based solely on the risk to animals or

plants, or to animal or plant products, including consideration of

the effect of exposure on the production and marketability of such

products. The Managers do not intend that the USDA Secretary

will include an agent or toxin on the USDA list because of the effect of that agent or toxin on human health, which is governed by

the statutory provisions of section 351A of the Public Health Service Act, as amended by this title.

The Managers expect that most ‘‘persons’’ who register under

this subtitle will be public and private entities, rather than individuals. But these provisions also will cover individuals possessing,

using or transferring listed agents who have not been granted authority to do so by registered persons. If an individual has not been

granted such authority, then that individual would be a person required to register under this subtitle. If an individual has been

granted such authority without proper authorization from the Secretary, as required by this subtitle, then the registered person is

subject to any penalties provided for violation of such regulations.

The Managers emphasize that the primary responsibility for registration and the screening of employees working with listed agents

is with the entity or employer, not the individual employee.

Procedures for the registration of persons, review of individuals, and inspection of facilities have been described in the statutory language in some detail. Of equal importance to the Managers

are the regulations, to be established by the Secretary, which, to

ensure compliance with this subtitle, shall include provisions for

the revocation and suspension of registrations for failure to maintain safe and secure facilities.

Section 213. Implementation by the Department of Agriculture

House provision and Senate amendment: Neither the House bill

nor the Senate amendment contain any analagous provision.

Conference substitute: The Conference substitute provides that,

within 60 days of enactment, the Secretary of Agriculture shall promulgate an interim final rule that establishes an initial list of

agents and toxins meeting the statutory criteria for enhanced regulation. Within 60 days of the publishing of the interim final rule,

all persons (unless exempt) must notify the Secretary of such possession. Within 180 days of enactment, the Secretary shall promulgate an interim final rule for carrying out the remainder of section

212, which such rule shall include time frames that minimize disruption of ongoing research and education with listed agents and

toxins.

Subtitle C—Interagency Coordination Regarding Overlap Agents

and Toxins

Section 221. Interagency Coordination

House provision: The House bill requires that the HHS Secretary

ensure that select agent regulations are coordinated with the existing regulations of USDA governing certain of the select agents that

are used in the development of vaccines or other products for the

treatment of domestic animals. The purpose of such coordination is

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to minimize conflict and duplication of administrative burdens of

registered persons.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute, in adding new

USDA regulatory authority comparable to that given HHS in subtitle A of this title, also adopts provisions that would facilitate coordination and cooperation between USDA and HHS with respect

to the regulation of those ‘‘overlap’’ agents or toxins that are regulated by both such agencies.

In the case of zoonotic agents that appear on both the USDA and

HHS lists of dangerous biological agents and toxins developed

under this title, the Managers intend that the two Secretaries shall

work cooperatively to develop a streamlined, joint registration

whereby the registrant shall be permitted to submit a single registration document to either USDA or HHS. Upon receipt of the

registration document, the receiving agency shall review the application and transfer it to the other agency in order that the second

agency may conduct an independent review. Upon completion of

the individual reviews by both agencies, and if both agencies concur that the registration should not be denied, the receiving agency

shall notify the prospective registrant of this determination. In the

absence of concurrence, the receiving agency shall notify the prospective registrant of the denial of the application.

The Managers intend that this system of joint registration should

be implemented through the development of a comprehensive

Memorandum of Understanding between the two agencies no later

than six months after the date of enactment of this act, which will

coincide with the issuance by each Secretary of an interim final

rule requiring the registration of listed agents and toxins. Until

such time as the Memorandum of Understanding is implemented,

the separate regulatory systems of USDA and HHS shall remain

in effect.

It is the Managers’ intent that the two Secretaries will coordinate closely with respect to exemptions from these new regulatory

regimes for overlap agents, so as to create a uniform and consistent

approach. The Managers also intend that, under the Memorandum

of Understanding, a regulated party will interact with one agency

with respect to all matters—including registration, screening, and

inspections—so as to avoid confusion and forum shopping. The

Managers also expect that the two Departments will coordinate

and consult with respect to overlap agent registration, screening,

and exemptions in a timely manner, particularly in situations of

public health or agricultural emergencies.

Within 18 months of the implementation of a Memorandum of

Understanding between USDA and HHS, the Managers intend that

a formal, joint regulatory system shall be implemented by the two

Departments for agents and toxins that appear on both the USDA

and HHS lists. Once implemented, the Managers intend that these

joint regulations shall supercede the Memorandum of Understanding with respect to matters covered by such regulations.

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Subtitle D—Criminal Penalties Regarding Certain Biological

Agents and Toxins

Section 231. Criminal Penalties

House provision: The House bill authorizes amendments to current law to require all persons who possess, use or transfer biological agents or toxins that have been listed as select agents by the

HHS Secretary to register with the Secretary. To enforce these new

regulatory provisions, subsection (a) of section 231 of the House bill

provides that any person who knowingly transfers a select agent to

any person without first verifying such registration with the Secretary could be fined or imprisoned up to five years, or both. The

subsection also provides that any person who knowingly possesses

a biological agent or toxin, where such agent or toxin is a select

agent for which such person has not obtained a registration required by the Secretary, could be fined or imprisoned for up to five

years, or both.

The House bill makes technical changes to 18 U.S.C. 175b to

renumber current subsection (a) as (a)(1), and to redesignate subsection (c) as (a)(2). This change will result in the description of the

possible penalties being placed immediately following the description of the unlawful conduct. The House bill also redesignates subsection (b) as subsection (d). The two new criminal provisions

added under this bill are designated subsections (b) and (c) of section 175b. The House bill also makes conforming amendments to

clarify the definition of the term ‘‘select agent.’’ The House bill also

changes the title of section 175b from ‘‘Possession by restricted persons’’ to ‘‘Select Agents.’’ Senate amendment: The Senate amendment includes the same

criminal provision relating to those who possess select agents without being registered, but differs with respect to the criminal penalty for unauthorized transfers. The Senate amendment criminalizes transfers to unregistered persons when the transferor has reason to believe that the recipient is not registered. The Senate

amendment also differs by including the unlawful conduct in 18

U.S.C. 175, rather than 175b. The Senate amendment makes conforming changes to 18 U.S.C. 175 to make the sections technically

correct and to eliminate a definition that is already provided in another section. The Senate amendment provides that current 18

U.S.C. 175(b) and (c) are redesignated as (c) and (d). New subsection (b) creates the criminal penalties referenced above. New

subsection (d), which contains the definitions, amends current law

to provide new definitions for the following terms: ‘‘biological

agent,’’ ‘‘for use as a weapon,’’ and ‘‘select agent.’’

Conference substitute: The Conference substitute adopts the

House language with regard to technical changes to 18 U.S.C.

175b, but adopts the Senate language with respect to new criminal

penalties with modifications. The Conference substitute adopts the

common language dealing with unlawful possession. However, the

Conference substitute amends the Senate language regarding

transfers to provide that any person who transfers a select agent

to any person one knows or has reasonable cause to believe has not

registered with the HHS Secretary could be fined or imprisoned up

to five years, or both.

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The Conference substitute also amends both bills by adding

language that requires all persons who possess, use or transfer biological agents that have been listed as agents that pose a threat

to agriculture by the Secretary of Agriculture to register with such

Secretary. The Conference substitute provides that knowing possession of a biological agent or toxin, where such agent or toxin is listed by the Secretary of Agriculture under this Act and for which a

required registration has not been obtained, is punishable by a fine

or up to five years imprisonment, or both. Similarly, transfer of a

biological agent or toxin listed by the Secretary of Agriculture to

a person one knows or has reasonable cause to believe has not registered with the Secretary is punishable by a fine or up to five

years imprisonment, or both.

The Conference substitute also makes additional conforming

and technical amendments to title 18, including providing a comma

in 18 U.S.C. 175(c); specifically describing what activities restricted

persons are prohibited from engaging in under this section; referring to the correct code section for the definition of ‘‘alien’’; replacing legislative language in 176(a)(1)(A); modifying the definitions in

18 U.S.C. 178 for ‘‘biological agent’’, ‘‘toxin’’, and ‘‘vector’’ to make

each more accurate; and modifying 18 U.S.C. 2332a regarding use

of weapons of mass destruction to make it clear it refers to use of

biological agents or toxins.

The Managers expect that most ‘‘persons’’ who register under

this title will be public and private entities, rather than individuals. When an entity fails to register as required, the new criminal

possession statutes will apply to that entity. These provisions also

will cover individuals possessing select or listed agents who are unregistered and who have not been granted access to such agents by

registered persons. If an individual has not been granted access by

a registered person, then that individual would be a person required to register under this title for purposes of these criminal

possession provisions. If an individual is granted access to a select

or listed agent by a registered person without proper authorization

from the Secretary, as required by this title, then the registered

person is subject to any penalties provided for violation of such regulations. The Managers emphasize that the primary responsibility

for registration and the screening of employees working with select

or listed agents is with the entity or employer, not the individual

employee. This same analysis applies to the criminal transfer provisions set forth in this section.

TITLE III—PROTECTING THE SAFETY AND SECURITY OF

THE FOOD AND DRUG SUPPLY

Subtitle A—Protection of Food Supply

For purposes of this Title, the term ‘‘Secretary’’ refers to the

Secretary of Health and Human Services, unless otherwise indicated.

Section 301. Food Safety and Security Strategy

House provision: The House bill contains no analogous provision.

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Senate amendment: The Senate amendment expands the responsibilities of the President’s Council on Food and Safety (established by Executive Order 13100) by directing the Council, with the

Secretary of Commerce and the Secretary of Treasury to develop a

crisis communications and education strategy with respect to bioterrorist threats to the food supply. The Senate amendment authorizes to be appropriated $500,000 to develop such a strategy.

Conference substitute: The Conference substitute adopts the

Senate amendment with modification. The Conference substitute

expands the scope of consultation between the President’s Council

on Food Safety and other entities to include any other relevant

Federal agencies, including law enforcement and intelligence related agencies, and scientific organizations. The Conference substitute also expands the scope of the food safety and security strategy to address technologies, threat assessments, risk communication, and procedures for securing food processing and manufacturing facilities and modes of transportation. The Conference substitute increases the amount of funds that are authorized to be appropriated for fiscal year 2002 to $750,000 to develop such a strategy.

Section 302. Protection Against Adulteration of Food

House provision: The House bill authorizes to be appropriated $100,000,000 for fiscal year 2002, and such sums as may be necessary for each year from fiscal year 2003 thorugh fiscal year 2006,

for the Secretary to carry out increased activities to ensure the

safety of the food supply. Specifically, the House bill amends section 801 of the Federal Food Drug and Cosmetic Act (FFDCA) directing the Secretary to give high priority to increasing the number

of food safety inspections at ports of entry, with highest priority on

inspections to detect intentional adulteration of food. The House

bill also directs the Secretary to give a high priority to improving

the information management systems that support food safety inspection programs for the purpose of improving the ability of the

Secretary to detect intentional adulteration of food and to facilitate

the importation of food that is in compliance with the Act. Further,

the House bill directs the Secretary to give high priority to researching and developing improved tests and sampling methods for

the purpose of rapidly detecting adulterated foods, with highest priority on detection of intentional adulteration. Finally, the House

bill directs the Secretary to complete an assessment of potential

threats to the food supply posed by efforts to intentionally adulterate food, and to report the findings on such assessment to Congress within six months.

Senate amendment: The Senate amendment authorizes to be

appropriated $59,000,000 for fiscal year 2002 and such sums as

may be necessary for each year thereafter to expand the capacity

of the Food and Drug Administration (FDA) to increase inspections

to ensure the safety of the food supply and to improve linkages between the FDA and other Federal regulatory agencies, the States,

and Indian tribes.

Conference substitute: The Conference substitute adopts the

House bill with modification. The Conference substitute directs the

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cies that share responsibility for food safety, and directs the Secretary to improve linkages with the States and Indian tribes with

respect to food safety. The Managers intend that the Secretary in

making improvements to the information management systems

that support food safety inspection programs, including the OASIS

system, may include improvements that assist food importers and

filers in providing accurate and timely information on entries filed

on food import shipments. The Managers also intend that in conducting research to develop improved tests and sampling methods

for the purpose of rapidly detecting adulterated foods, the Secretary may involve institutions of higher education, including such

institutions that receive Federal funding to operate consortiums

within the food industries, for the purpose of conducting research

and development in food safety and food security. Finally, it is the

understanding of the Managers that FDA already has underway

(under agreement with Battelle Laboratories) an assessment of potential threats to the food supply posed by efforts to intentionally

adulterate food. For purposes of this section, the requirement to

conduct an assessment of potential threats to the food supply posed

by efforts to intentionally adulterate food refers to such threat assessment that is already underway or very recently completed.

Section 303. Administrative Detention

House provision: The House bill amends section 304 of the

FFDCA by authorizing the Secretary to administratively detain an

article of food that is found during an inspection, examination or

investigation under this Act if the Secretary has credible evidence

or information indicating that the article presents a threat of serious adverse health consequences or death to humans or animals.

Such food may be detained for a reasonable period of up to 20 days,

and where needed up to 30 days, for the purpose of enabling the

Secretary to institute a seizure action under section 304(a) or injunctive relief under section 302, as warranted. The House bill authorizes the Secretary to move detained food from the place at

which it has been detained to a secured facility, as appropriate, for

the period of detention or until released by the Secretary. The

House bill also authorizes a claimant of an article of food that has

been detained under this section to appeal the detention of the article. In addition, where the Secretary already has credible evidence

or information indicating that an imported article of food presents

a threat of serious adverse health consequences or death to humans or animals, this section also requires the Secretary to request

the Secretary of Treasury to temporarily hold imported food at a

port of entry for up to 24 hours to enable the Secretary to inspect,

examine or investigate the food. For an article of food temporarily

held under this section, the Secretary is also required to notify the

State in which the port of entry is located about such request or

that such food is being temporarily held.

Senate amendment: The Senate amendment provides authority

to administratively detain food that is similar to the House bill.

The Senate amendment allows the Secretary to detain food that

violates the FFDCA and that presents a threat of serious adverse

health consequences or death, and requires that the Secretary provide an opportunity for a hearing (and to confirm or to revoke) a

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detention order within 15 days of the filing of an appeal by a claimant. Unlike the House bill, the Senate amendment does not include

additional authority to temporarily hold food, nor does it require

the Secretary to notify a State regarding the port of entry within

such State at which food is being temporarily held.

Conference substitute: The Conference substitute adopts the

House bill with modification. The Conference substitute clarifies

that food that is detained under this section may not be delivered

pursuant to an execution of a bond in accordance with section 801

of the FFDCA (if the detained food is imported) or otherwise (if the

detained food is domestically produced), while the food is subject to

the detention order, unless released by the Secretary. The Conference substitute requires the Secretary in response to an appeal

filed by a claimant challenging the detention of an article of food

to conduct an informal hearing and confirm or terminate a detention order within five days after an appeal is filed, at which time

the Secretary’s determination is subject to judicial review in accordance with section 702 of title 5, United States Code. The Conference substitute amends section 304 of the FFDCA by authorizing the Secretary to detain an article of food for the purpose of

enabling the Secretary to institute a seizure action under section

304(a) or to seek injunctive relief under section 302 of the Act. This

section provides a claimant of the food the right to appeal a detention order, but that right of appeal terminates if the Secretary institutes either a seizure action under section 304(a) or injunctive

relief under section 302 of the Act. The Managers do not intend to

terminate the claimant’s right to appeal a detention order under

paragraph 4(B) of such subsection, unless the basis for the seizure

action instituted under section 304(a) or the injunctive relief sought

under section 302 is related to the original basis for detention

under this section.

The Conference substitute provides that an article of food subject to detention shall be held in a secure facility, as appropriate.

Under this title, in instances where the Secretary moves food that

has been refused admission to a secure facility, the Secretary

should ensure that such food will be held under appropriate conditions of cleanliness, temperature, humidity and other such considerations that are necessary so as not to erode the safety and wholesomeness of the detained article.

The Managers recognize that perishable foods may be detained

under this section. As a result, the Secretary is required to promulgate a rule to establish expedited procedures for instituting an action under section 304(a) or section 302 of the FFDCA for perishable foods, such as fresh produce, fresh fish and fresh seafood products. The Secretary should promptly complete such rule making.

The Conference substitute requires the Secretary to temporarily hold food for not longer than 24 hours, where the Secretary

has credible evidence or information indicating that such article of

food presents a threat of serious adverse health consequences or

death to humans or animals. The period of temporary hold is intended to allow the Secretary time to dispatch an inspector to the

port of entry in order to conduct the needed inspection, examination or investigation.

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Section 304. Debarment for Repeated or Serious Food Import Violations

House provision: The House bill provides authority to the Secretary to debar from importing articles of food, any person that is

convicted of a felony relating to food importation or any person that

repeatedly imports food and who knew, or should have known, that

such food was adulterated. The House bill treats the importation

or offer for importation of an article of food by a debarred person

as a prohibited act under section 301 of the FFDCA.

Senate amendment: The Senate amendment includes permissive debarment authority for food importers that is similar to the

permissive debarment authority of the House bill, but replaces the

standard in the House bill, allowing debarment for repeatedly importing unsafe food, with a different standard allowing debarment

of food importers for engaging in a pattern of importing unsafe

food. Unlike the House bill, the Senate amendment treats food that

is imported by a debarred person as adulterated.

Conference substitute: The Conference substitute adopts the

Senate amendment with modification. Unlike the Senate amendment, the Conference substitute does not treat food that is imported by a debarred person as adulterated solely on the basis of

its importation by a debarred person. Rather the Conference substitute treats the importation or offering for importation into the

United States of an article of food by, and with the assistance of,

or at the direction of, a debarred person as a prohibited act under

section 301 of the FFDCA. In addition, the Conference substitute

requires food imported by a debarred person to be refused admission and held in a secure facility, as appropriate, unless a person,

other than a debarred person, affirmatively establishes that such

food complies with the requirements of the FFDCA. The Conference

substitute also clarifies that imported food that is refused admission may not be delivered pursuant to the execution of a bond

under subsection (b) of section 801 of the FFDCA. For purposes of

this section, the person other than the debarred person who may

established that food, which has been refused admission under this

section, is in compliance with this Act is intended to be an innocent

purchaser of food, not a person that is engaged in the improper importation of food with a debarred person. In addition, the classification as a prohibited act (under section 301 of the FFDCA) of the

importation or offer for importation of food ‘‘with the assistance of’’ a debarred person is not intended to include an innocent purchaser

who did not have knowledge, actual or constructive, of the importer’s debarred status. Finally, the Conference substitute clarifies

that the Secretary has the authority to terminate the debarment

of corporations or persons under this subsection.

Section 305. Registration of Food Facilities

House provision: The House bill requires facilities (excluding

farms) that manufacture, process, pack or hold food for consumption in the United States to file with the Secretary, and keep up

to date, a registration that contains the identity and address of the

facility and, when the Secretary determines appropriate the general category of food manufactured, processed, packed or held at

the facility. The House bill also authorizes the Secretary to exempt

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certain retail establishments only if the Secretary determines that

the registration of such facilities is not needed for effective enforcement. Enforcement of this section is delayed one hundred and

eighty days from the date of enactment, and this section requires

the Secretary to notify and issue guidance within sixty days identifying facilities that are required to register under this section.

Senate amendment: The Senate amendment includes a requirement for certain food facilities to register with the Secretary that

is similar to the registration requirement for food facilities that is

contained in the House bill. The Senate amendment exempts types

of farms or retail establishments but, unlike the House bill, farms

can be exempted only if the Secretary determines that the registration of such facilities is not needed for effective enforcement of the

FFDCA. The Senate amendment also lacks the requirements of the

House bill relating to notice to those who must register and relating to electronic registration.

Conference substitute: The Conference substitute adopts the

Senate amendment with modification. The Conference substitute

requires the Secretary to establish registration requirements for

specified food facilities by regulation not later than eighteen

months after the date of enactment of this Act. If such regulations

are not effective prior to the conclusion of such eighteen-month period, the requirements of this section are self-executing and enter

into effect at such time and remain in effect unless superseded by

such final regulations. The Managers strongly encourage the Secretary to complete this rule making in a timely manner in order

to enable the efficient operation of these registration requirements.

The Conference substitute treats the failure of a specified facility to register under this section as a prohibited act under section

301 of the FFDCA. The Conference substitute requires the Secretary to refuse admission to food imported from foreign facilities

that have failed to register in accordance with this section until

such facility is registered, and requires the Secretary to remove

such food to a secure facility, as appropriate. The Conference substitute clarifies that imported food that is refused admission under

this section shall not be delivered pursuant to the execution of a

bond under subsection (b) of section 801 of the FFDCA.

The Conference substitute exempts from the requirements of

registration farms, restaurants, other retail food establishments,

non-profit food establishments in which food is prepared for, or

served directly to, the consumer, and fishing vessels not engaged

in processing, as defined in section 123.3(k) of title 21, Code of Federal Regulations. The Managers intend that, for purposes of this

section, the term ‘‘retail food establishments’’ includes establishments that store, prepare, package, serve or otherwise provide articles of food directly to the retail consumer for human consumption,

such as grocery stores, convenience stores, cafeterias, lunch rooms,

food stands, saloons, taverns, bars, lounges, catering or vending facilities, or other similar establishments that provide food directly

to a retail consumer. The term does not include a warehouse that

does not provide articles of food directly to a retail consumer as its

primary function. The Managers intend that, for purposes of this

section, the term ‘‘non-profit food establishments’’ includes not-forprofit establishments in which food is prepared for, or served diVerDate 11-MAY-2000 10:31 May 23, 2002 Jkt 099006 PO 00000 Frm 00137 Fmt 6604 Sfmt 6601 E:\HR\OC\HR481.XXX pfrm01 PsN: HR481
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rectly to the consumer, such as food banks, soup kitchens, homebound food delivery services, or other similar charitable organizations that provide food or meals for human consumption. In addition, the Managers intend that, for purposes of this section, ‘‘facility’’ does not include trucks or other motor carriers, by reason of

their receipt, carriage, holding, or delivery of food in the usual

course of business as carriers. In addition, nothing in this section

shall be construed to alter or amend the treatment of carriers

under section 703 of the FFDCA.

Finally, the Conference substitute calls for one-time registration of covered facilities, rather than annual registration of such facilities. Once a facility is registered it should amend its original

registration in a timely manner to reflect any changes. The Conference substitute encourages electronic registration to help reduce

paperwork and reporting burden, but registration is also permitted

using a paper form.

Section 306. Maintenance and Inspection of Records for Foods

House provision: The House bill provides the Secretary with

authority to inspect and copy all records relating to an article of

food if the Secretary has credible evidence or information indicating

that an article of food presents a threat of serious health consequences or death to humans or animals. The House bill contains

certain limitations on the Secretary’s authority, including limitations to ensure the protection of trade secrets and confidential information. The House bill provides the Secretary with the discretion to issue a regulation requiring maintenance of additional

records that are needed to identify the source and chain of distribution of food, in order to address credible threats of serious adverse

health consequences or death to humans or animals. The House bill

excludes restaurants and farms, and the Secretary is provided the

authority to take into account the size of the business when imposing any record keeping requirements.

Senate amendment: The Senate amendment includes records

access authority that is similar to the records access authority

granted to the Secretary in the House bill. The Senate amendment

authorizes the Secretary to inspect and copy records relating to the

violation when he has a reason to believe that an article of food is

adulterated or misbranded and presents a threat of serious adverse

health consequences or death. The Senate amendment also includes record keeping authority that is similar to the record keeping authority in the House bill. The Senate amendment requires

the Secretary to issue a regulation to require the maintenance and

retention of records to trace the chain and distribution of food within 18 months of enactment of the Act. In addition, the Senate

amendment allows the Secretary to require maintenance and retention of records necessary to determine if a food may be adulterated

or misbranded to the extent that it presents a threat of serious adverse health consequences or death. The Senate amendment limits

the Secretary’s authority to require the retention of either type of

records for not longer than two years. The Senate amendment also

criminalizes the release of trade secret information obtained by inspection of records under this section.

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Conference substitute: The Conference substitute adopts the

House bill with modification. The Conference substitute replaces

the standard for records acccess in the House bill with a different

standard that grants the Secretary records access if the Secretary

has a reasonable belief that an article of food is adulterated and

presents a threat of serious adverse health consequences or death

to humans or animals. The Conference substitute limits access to

those records relating to such article of food that are needed to assist the Secretary in determining whether food is adulterated and

presents a threat of serious adverse health consequences or death

to humans or animals.

The Conference substitute amends the scope of record keeping

authority contained in the House bill by clarifying that the authority under this section applies to both the establishment and maintenance of records that meet the standard under this section and

by limiting the record retention requirement to a period of not

longer than 2 years. The Conference substitute also adopts the requirement of the Senate amendment to criminalize the disclosure

of trade secrets obtained under this section.

The Conference substitute authorizes the issuance of regulations to require establishment and maintenance of chain of distribution records. This authority should not be used to require a

business to maintain records regarding transactions or activities to

which it was not a party. The Managers intend that those records

that document the person from whom food was directly received,

and to whom food was directly delivered, are adequate to enable

identification of the source and distribution of food. As a result, for

purposes of this section, the terms ‘‘immediate previous sources’’ and ‘‘immediate subsequent recipients’’ refer to the person from

whom the food was received and the person to whom the food was

delivered, respectively.

The Managers did not adopt a Senate proposal to authorize the

Secretary to require the maintenance and retention of other records

for inspection relating to food safety, because the Secretary has authority under section 701(a) of the FFDCA to issue regulations for

the ‘‘efficient enforcement of this Act’’ and this authority, in combination with other provisions (such as section 402), gives the Secretary the authority to require appropriate record keeping in food

safety regulations.

Section 307. Prior Notice of Imported Food Shipments

House provision: The House bill directs the Secretary by regulation to require importers of articles of food to provide up to seventy-two hours, but not less than twenty-four hours, prior notice

that food will be imported or offered for import into the United

States. The House bill requires that the notice contain the following information: a description of food to be imported; the identity of the manufacturer and shipper; and, if known within the

specified period of time that notice is required to be provided, the

identity of the grower; the country of origin of the article; the country from which the food is being shipped; and the anticipated port

of entry into the United States. In the event notice is not provided

in advance of importation in accordance with the Secretary’s regulation, the food shall be held at the port of entry until notice is

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properly provided and the Secretary determines whether there is

credible evidence or information in his possession indicating that

the article presents a threat of serious adverse health consequences

or death to humans or animals.

Senate amendment: The Senate amendment, like the House

bill, includes a requirement that food importers provide prior notice

to the Secretary of incoming food imports. The Senate amendment

differs from the requirement in the House bill, because the prior

notice requirement in the Senate amendment is self-effectuating

upon enactment of the Act and requires at least four hours minimum prior notice and no limitation on the maximum notice allowable. The Senate amendment requires that the notification contain

the identity of the food, the food’s country of origin, the quantity

imported, and other information that the Secretary may require by

regulation. Finally, if an importer fails to provide the required

prior notice, under the Senate amendment the Secretary is provided with discretion to refuse admission into the United States of

the food.

Conference substitute: The Conference substitute adopts the

House amendment with modification. The Conference substitute requires the Secretary to establish by regulation the period of time

for prior notice, that must be no less than the minimum amount

of time necessary for the Secretary to receive, review, and appropriately respond to the notice, but that may not exceed five days.

In determining the specified period of time for prior notice, by regulation, the Conference substitute identified several factors the Secretary may take into account, including the effect on commerce, the

locations of various ports of entry, the various modes of transportation, the types of food imported into the United States, and other

such considerations. Nothing in the preceding sentence may be construed as a limitation on the obligation of the Secretary to receive,

review, and appropriately respond to any notice under this section.

The Conference substitute treats the failure to provide adequate prior notice under this section as a prohibited act under section 301 of the FFDCA. The Conference substitute requires the

Secretary to refuse admission to food imported without properly

providing prior notice in accordance with this section until such

prior notice is properly provided. In addition, the Conference substitute requires the Secretary to remove such food to a secure facility, as appropriate and clarifies that imported food that is refused

admission under this section shall not be delivered pursuant to the

execution of a bond under subsection (b) of section 801 of the

FFDCA.

The Conference substitute directs the Secretary to establish

prior notice requirements for imported foods by regulation not later

than eighteen months after the date of enactment of this Act. If

such regulations are not effective prior to the conclusion of such

eighteen-month period, the requirements of this section are selfexecuting and enter into effect at such time and remain in effect

unless superseded by such final regulations. In addition, at the conclusion of the eighteen-month period, if such final regulations are

not effective, the Conference substitute establishes a default period

of time for prior notice of not less than 8 hours and not more than

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lations. The Managers strongly encourage the Secretary to complete this rule making in a timely manner in order to enable the

efficient operation of these requirements.

The Managers intend that the requirements of this section

should not be construed to apply to packaging materials if, at the

time of importation, such materials will not be used for, or in contact with, food as defined under section 201 of the FFDCA. Nothing

in this section shall be construed to alter or amend the regulatory

treatment of food packaging materials or food contact substances

under the FFDCA. Also, the Conference substitute requires the importer of an article of food to provide information about the grower

of the article of food, but this provision only requires the importer

to provide the identity of the grower of the article of food if known

during the period of time in which prior notice is required to be

provided. Finally, the Secretary shall consult and coordinate with

the Secretary of Treasury in developing the prior notice regulation.

This section of the Conference substitute contains prior notice requirements for imported food and is not intended as a limitation

on the port of entry for an article of food.

Section 308. Authority to Mark Articles Refused Admission into

United States

House provision: The House bill requires that food that has

been refused admission to the United States, but has not been ordered destroyed, may have a label affixed to its container at the expense of the owner or consignee indicating that it has been refused

admission.

Senate amendment: The Senate amendment, similar to the

House bill, includes authority regarding the marking of food that

has been refused admission into the United States. Unlike the

House bill, the Senate amendment provides the Secretary with a

broader authority than the House bill to mark foods as refused admission, including foods that have not been determined to present

a threat of serious adverse health consequences or death to humans or animals. The Senate contains an enforcement provision

under which food that has been refused admission but that has not

been properly marked as refused admission is treated as misbranded if it is determined that it presents a threat of serious adverse health consequences or death to humans or animals.

Conference substitute: The Conference substitute adopts the

House bill with modification. The Conference substitute provides

the Secretary with discretionary authority to require that items

that have been refused admission to the United States under section 801 of the FFDCA shall be so marked. The Conference substitute clarifies that the marking of such items may be applied to

the container of the food. The Conference substitute also requires

the Secretary to notify the owner or consignee of an article of food

that has been refused admission and that has been required to be

so marked under this section, if at some time subsequent to requirement to mark the food, the Secretary determines that the food

is misbranded and presents a threat of serious adverse health consequences or death to humans or animals.

Nothing in this section shall be construed to alter or amend

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cle of food that has been relabeled, reconditioned or otherwise

brought into compliance with the Act in accordance with subsection

(b) of section 801 of the Act.

Section 309. Prohibition Against Port Shopping

House provision: The House bill requires any person attempting to re-offer for admission an article of food at a port of entry into

the United States, after it has been previously refused admission

at another port of entry into the United States, to affirmatively establish that the food is not adulterated.

Senate amendment: The Senate amendment contains a prohibition against port shopping that is comparable to the prohibition

contained in the House bill. The Senate amendment prohibits a

person from port shopping with respect to food that has been refused admission, by requiring that the person show that food that

has been refused admission previously, has been brought into compliance with the applicable requirements of the FFDCA.

Conference substitute: The Conference substitute adopts the

Senate amendment without modification.

Section 310. Notice to States Regarding Imported Food

House provision: The House bill requires that where the Secretary has credible evidence or information indicating that an article of food presents a threat of serious adverse health consequences

or death to humans or animals, the Secretary shall provide notice

regarding the threat posed by such food to those States in which

the food is held or will be held and shall request that such States

take appropriate remedial action.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House bill with modification. The Conference substitute clarifies

the scope of the rule of construction included in subsection (b) of

this section.

Section 311. Grants to States for Inspections

House provision: The House bill authorizes the Secretary to

make grants for increased food safety inspections, examinations, investigations and related activities and to assist States in taking appropriate actions to respond to any Federal notice received pursuant to section 309 (governing notice to States) of the House bill.

The House bill authorizes to be appropriated such sums as may be

necessary for fiscal year 2002 through fiscal year 2006 to establish

and carry out the grants under the section.

Senate amendment: The Senate amendment authorizes the

Secretary to make grants to States, territories, and Federally recognized tribes to cover the cost of food safety examinations, inspections, investigations, and related activities under section 702 of the

FFDCA, and it authorizes to be appropriated $10 million in fiscal

year 2002 and such sums as may be necessary for each year thereafter for such purpose.

Conference substitute: The Conference substitute adopts the

House bill with modification. The Conference substitute extends

the grants made available under this section to Indian tribes to the

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extent they undertake inspections, investigations or examinations

under section 702 of the FFDCA. The Conference substitute authorizes to be appropriated $10 million in fiscal year 2002 and such

sums as may be necessary for each fiscal year 2003–2006 for such

purpose.

Section 312. Surveillance and Information Grants and Authorities

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment authorizes the

Secretary to award grants to States to increase participation in

Pulsenet, the Foodborne Diseases Active Surveillance Network, and

other such networks, and authorizes to be appropriated $19.5 million in fiscal year 2002, and such sums as may be necessary each

year for such purpose from fiscal year 2003 through fiscal year

2006.

Conference substitute: The Conference substitute adopts the

Senate amendment with modification. The Managers intend that

funds awarded under this section shall be used by States and Indian tribes to assist in meeting the costs of establishing and maintaining the food safety surveillance, technical and laboratory capacity needed to participate in programs, including Pulsenet,

Foodborne Diseases Active Surveillance Network, and other networks to enhance Federal, State, and local food safety efforts.

Section 313. Surveillance of Zoonotic Disease

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment requires the Secretary of Health and Human Services and the Secretary of Agriculture to develop and implement a plan for the surveillance of

zoonotic and human disease.

Conference substitute: The Conference substitute adopts the

Senate amendment with modification. The Conference substitute

directs the Secretary, through the Commissioner of FDA and the

Director of the Centers for Disease Control and Prevention (CDC),

and the Secretary of Agriculture to coordinate the surveillance of

zoonotic diseases.

Section 314. Authority to Commission Other Federal Officials to

Conduct Inspections

House provision: The House bill does contain no analogous provision.

Senate amendment: The Senate amendment includes authority

that is not included in the House bill that allows the Secretary to

commission officers and qualified employees of other Federal Departments or Federal agencies to conduct examinations and inspections for the Secretary under section 702 of the FFDCA.

Conference substitute: The Conference substitute adopts the

Senate amendment with modification. The Conference substitute

clarifies that the authority of the Secretary to commission other

Federal officials to conduct inspections, examinations and investigations under section 702 of the FFDCA shall be carried out pursuant to a memorandum of understanding between the Secretary

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and the head of the Department or agency of such other Federal

employees.

Section 315. Rule of Construction

House provision: The House bill does contain no analogous provision.

Senate amendment: The Senate amendment includes a rule of

construction that applies to the amendments made in Title V of the

Senate amendment that provides that such amendments do not

provide the FDA with additional authority over meat, poultry, and

egg products, nor do such amendments limit the authority of the

Department of Agriculture over such products.

Conference substitute: The Conference substitute adopts the

Senate amendment with modification. The Conference substitute

clarifies that nothing in this Title, or an amendment made by this

Title, shall be construed to alter the jurisdiction between the Secretary and the Secretary of Agriculture, under applicable statutes

and regulations.

Subtitle B—Protection of Drug Supply

Section 321. Annual Registration of Foreign Manufacturers; Shipping Information; Drug and Device Listing

House provision: The House bill mandates annual registration

of foreign manufacturers engaged in the import of drug and device

products into United States. The House bill also requires that the

annual registration include information on each importer or carrier

transporting the foreign manufacturer’s drug or device products.

The House bill also directs that the registration and listing numbers be included in the declaration for the products when offered

for import.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House bill with modification. The conference substitute requires

registration through electronic means. The Conference substitute

deletes carrier in the annual registration and replaces with ‘‘person

who imports or offers for import.’’ The Conference substitute makes

non-registration a prohibited act rather than deeming it misbranded. Non-registration is a failure to comply with the Secretary’s request to submit registration information. The Conference

substitute provides for a non-registered drug or device to be removed to a secure facility until non-registration is cured. For purposes of this section, the Managers intend ‘‘person who imports or

offers for import’’ to capture import brokers and other persons who

file import-related paperwork with the U.S. Customs Service or the

FDA.

Section 322. Requirement of Additional Information Regarding Import Components Intended for Use in Export Products

House provision: The House bill mandates a chain of possession identification and a customs bond for those firms that seek to

import components of drugs, devices, food additives, color additives,

or dietary supplements for further processing and export. The

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House bill requires certificates of analysis for components containing any chemical substance or biological substance intended for

export.

Senate provision: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House bill with modification. The Conference substitute deletes reference to carriers in chain of possession identification. The Conference substitute exempts devices and products covered by section

801(d)(4) of the FFDCA from the certificate of analysis requirement. The Conference substitute clarifies that the provisions permitting import-for-export do not apply to articles for which the Secretary of Health and Human Services determines that there is

credible evidence or information indicating the article is not intended to be imported for export.

The Managers understand this section does not change any

definitions of regulated articles or the scope of regulation of those

articles as set forth in the FFDCA and its implementing regulations.

The Managers intend that this section shall not be construed

to restrict or facilitate the entry of articles imported for research

and development or quality assurance purposes under subsection

801(d)(3) of the FFDCA beyond the existing authority.

For the purposes of articles subject to subsection 801(d)(4) of

the FFDCA, the Managers understand that the collection agency

would be considered the first manufacturer under subsection

801(d)(3)(A)(i)(II) of the FFDCA, relating to the chain-of-possession.

The Managers agree that certificates of analysis are not required if the only chemical or biological component of the article

imported under subsection 801(d)(3) of the FFDCA is de minimis,

incidental and poses no danger to human or animal health. Further, the Managers expect that the Secretary will understand that

‘‘certificate of analysis’’ is a widely understood and utilized document to assure the identity of the substance and its components in

the chemical and drug industries. However, the Secretary in consultation with other affected industries may accept documents that

convey equivalent assurance as to the identity of the article and its

components or substances. For example, the Secretary may determine that for an article of food additive or color additive, a document indicating specification of purity serves as the functional

equivalent of a certificate of analysis and meets the requirement of

a certificate analysis for purposes of this section. This section exempts devices and blood and blood products covered under subsection 801(d)(4) of the FFDCA from the certificate of analysis requirement.

The Managers do not intend the Secretary of the Treasury to

engage in a new rulemaking to specify the requirement for the

bonding of goods imported under subsection 801(d)(3) of FFDCA.

Existing requirements for the bonding of goods imported for further

processing and export should be applied.

The Managers agree that articles imported for export under

this section 322 which otherwise meet the requirements of this section should be permitted entry unless the Secretary determines

there is credible evidence or information that an article offered for

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import is not intended to be imported for export. In this regard, the

Managers believe that refusal of entry should not involve shipments between known shippers and known recipients unless the

Secretary has received credible evidence or information that suggests such shipments may not be legitimate. The Managers intend

to permit the Secretary to refuse admission of articles if the Secretary determines there is credible evidence or information that the

articles may be used as instruments of terror. Such evidence might

include highly toxic or otherwise exceptionally dangerous products

going to recipients unknown to the Secretary or to recipients believed to lack the capacity to further process such dangerous articles, for example, nitroglycerin imported under this section for delivery to a business other than a pharmaceutical manufacturer.

Such standard may also include, for example, presentation for

entry of articles not consistent with the accompanying documentation.

Subtitle C—General Provisions Relating to Upgrading of

Agricultural Security

Section 331. Expansion of Animal and Plant Health Inspection

Service Activities

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment requires the Secretary of Agriculture to enhance and expand the capacity of the

Animal and Plant Health Inspection Service (APHIS) to protect

against the threat of bioterrorism, including through increased inspection capacity internationally, improved surveillance at ports of

entry, and enhanced protections against terrorist use of plant and

animal disease organisms. The Senate amendment also requires

the Secretary of Agriculture to implement and then expand a hightech agriculture early warning and emergency response system, as

well as an automated record keeping system to track animal and

plant shipments. The Senate amendment authorizes the appropriation of $30 million in fiscal year 2002 and such sums in each year

thereafter, as may be necessary for such purposes.

Conference substitute: The Conference substitute adopts the

Senate amendment with modification. The Conference substitute

clarifies that this section provides additional authorization of appropriations to the Secretary of Agriculture to utilize existing authorities to give high priority to enhancing and expanding the capacity of APHIS to conduct the specified activities and to otherwise

improve the capacity of APHIS to protect against the threat of bioterrorism. The Conference substitute authorizes to be appropriated

$30 million for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year.

Section 332. Expansion of Food Safety Inspection Service Activities

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment requires the Secretary of Agriculture to enhance and expand the capacity of the

Food Safety Inspection Service (FSIS) to protect against the threat

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of bioterrorism, including through enhanced ability to inspect meat

and poultry products and increased inspections of meat and meat

products, poultry and poultry products, and egg products at ports

of entry. The Senate amendment authorizes the appropriation of

$15 million in fiscal year 2002 and such sums in each year thereafter, as may be necessary for such purposes.

Conference substitute: The Conference substitute adopts the

Senate amendment with modification. The Conference substitute

authorizes to be appropriated $15 million in fiscal year 2002 and

such sums in each year thereafter, as may be necessary for the the

purpose of providing additional authorization to the Secretary of

Agriculture to utilize existing authorities to give high priority to

enhancing and expanding the capacity of FSIS to conduct the specified activities and to otherwise improve the capacity of FSIS to protect against the threat of bioterrorism.

Section 333. Biosecurity Upgrades at the Department of Agriculture

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment authorizes to be

appropriated $180 million in fiscal year 2002 to update, renovate,

and expand the Department of Agriculture laboratory and research

facilities at Plum Island Animal Disease Center and the Agricultural Research Service and Animal and Plant Health Inspection

Service facility in Ames, Iowa, and also authorizes such sums as

may be necessary in each year from fiscal year 2003 through fiscal

year 2006, for those facilities, and for similar improvements at two

other Department of Agriculture facilities, one in Athens, Georgia,

and the other in Laramie, Wyoming.

Conference substitute: The Conference substitute adopts the

Senate amendment without modification. In addition to the biosecurity upgrades at the Department of Agriculture authorized in

this section, the Managers intend that the Secretary of Health and

Human Services shall also continue to take such actions as may be

necessary to secure existing facilities of the Department of Health

and Human Services where potential animal and plant pathogens

are housed and researched.

Section 334. Agricultural Biosecurity

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment requires the Secretary of Agriculture to establish minimum security standards and

award grants of up to $50,000 to land grant universities to assess

security needs and plan upgrades of both security of facilities

where hazardous biological agents or toxins are stored or used, and

communication networks about such agents or toxins, as well as to

develop a national inventory of such agents and toxins. The Senate

amendment also requires the Secretary of Agriculture to provide

for screening of personnel who require access at agricultural research facilities, and to develop and implement educational programs directed at biosecurity at agricultural facilities, including

farms, livestock confinement operations, and crop producers, handlers, processors, and transporters, as well as educational programs

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related to animal quarantine and testing. The Senate amendment

authorizes to be appropriated $20 million in fiscal year 2002 and

such sums in each year thereafter, as may be necessary for such

purposes.

Conference substitute: The Conference substitute adopts the

Senate amendment with modification. The Conference substitute

authorizes to be appropriated such sums as may be necessary for

the Secretary of Agriculture to award grants of up to $50,000 each,

to colleges and universities that have food and agricultural science

programs to review security standards and practices at their facilities in order to protect against bioterrorist threats. The Conference

substitute also authorizes the Secretary of Agriculture to award

grants, of up to $100,000 per association, to associations of food

producers or consortia of such associations for the development and

implementation of educational programs to improve bio-security on

farms against bioterrorist attacks.

Section 335. Agricultural Bioterrorism Research and Development

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment requires the Secretary of Agriculture, to the maximum extent practicable, to expand research and development programs of the Agricultural Research Service and the Cooperative State Research Education and

Extension Service to protect the nation’s food supply from bioterrorism, including by enhancing their capability to respond to the

needs of other food and agricultural regulatory agencies, continuing

existing partnerships with institutions of higher education with

programs related to agricultural biosecurity, and by strengthening

linkages with the intelligence community. The Senate amendment

authorizes the appropriation of $190 million in fiscal year 2002 and

such sums in each year thereafter, as may be necessary for such

purposes.

Conference substitute: The Conference substitute adopts the

Senate amendment with modification. The Conference substitute

authorizes to be appropriated $190 million in fiscal year 2002 and

such sums in each year thereafter, as may be necessary for the Secretary of Agriculture to utilize existing research authorities and

programs to protect the food supply of the United States by conducting various research activities, including developing new and

continuing partnerships with institutions of higher education and

other institutions to establish and enhance bio-security and food

safety programs, with special emphasis on vulnerability analyses,

incident response, detection and prevention technologies. The Conference substitute also authorizes the Secretary of Agriculture to

continue research to develop improved rapid detection field test

kits to detect biological threats to plants and animals for use in responding to bioterrorism, and to develop an agriculture bioterrorism early warning surveillance system by enhancing the capacity of and coordination between State veterinary diagnostic laboratories, Federal and State agricultural research facilities, and public

health agencies.

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Section 336. Animal Enterprise Terrorism Penalties

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute amends section 43(a) of title 18, United States Code, establishing a Federal

criminal offense against a person traveling in interstate or foreign

commerce for intentionally damaging or causing the loss of any

property used by the animal enterprise, or conspiring to do such activities. The Conference substitute establishes penalties for such

criminal offense and authorizes restitution for economic damage resulting from the loss.

TITLE IV—DRINKING WATER SECURITY AND SAFETY

The conference agreement builds upon title IV of the House bill

to ensure that drinking water systems across the country assess

their vulnerability to terrorist attack and develop emergency plans

to prepare for and respond to such attacks. Americans deserve to

know that the water they drink everyday is safe. The legislation

will lay the groundwork for developing the necessary information,

and emergency planning and response efforts that are needed to

address potential terrorist attacks at drinking water systems.

Section 401. Terrorist and Other Intentional Acts

House provision: The House bill requires community water systems serving over 3,300 persons to conduct vulnerability assessments. These requirements are phased-in, depending on the size of

the community water system. Community water systems serving

over 100,000 persons must complete a vulnerability assessment by

December 31, 2002; community water systems serving over 50,000

persons must complete a vulnerability assessment by June 30,

2003; community water systems serving over 3,300 persons must

complete a vulnerability assessment by December 31, 2003. Each

community water system must certify to the Administrator of the

Environmental Protection Agency (EPA) that they have conducted

a vulnerability assessment. The Administrator of EPA is also required to provide baseline information by June 1, 2002 regarding

which kinds of terrorist attacks or other intentional acts are probable threats.

The House bill also requires community water systems to prepare or revise emergency response plans that incorporate the results of the vulnerability assessments. Community water systems

must certify to the Administrator of the Environmental Protection

Agency within 6 months of the completion of a vulnerability assessment that they have completed an emergency response plan. To the

extent possible, community water systems are to coordinate with

Local Emergency Planning Committees when preparing or revising

an emergency response plan. The House bill additionally requires

EPA to provide guidance to community water systems serving

under 3,300 persons on how to conduct vulnerability assessments

and prepare emergency response plans.

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In order to carry out the provisions of the section, the House

bill authorized $120 million in Fiscal Year 2002 and such sums as

necessary in Fiscal Years 2003 and 2004. The funds are made

available for purposes of complying with vulnerability assessment

and emergency response plan requirements and to address basic

security enhancements of critical importance and significant

threats to public health as determined by a vulnerability assessment.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House provision with modifications. The Conference substitute extends dates for certifying that systems have completed a vulnerability assessment by three months for systems serving over

100,000 persons and by six months for all other systems. The substitute also extends the time for EPA baseline information to August 1, 2002 to reflect the passage of time between House action

and conference agreement.

The Conference substitute also adds the requirement that community water systems provide a copy of their vulnerability assessment to the Administrator of the EPA. Under the conference substitute, however, information that is provided by a community

water system to EPA and information that is derived thereof is exempt from disclosure under the Freedom of Information Act except

for information that identifies the community water system and the

date on which a community water system certifies to EPA that it

has completed a vulnerability assessment. In addition, no community water system shall be required under State or local law to provide an assessment to any State, regional or local governmental authority solely by reason of the requirements to submit such assessment to the Administrator of EPA.

The Administrator of the EPA is also required, by November

30, 2002 to develop protocols to protect the assessments from unauthorized disclosure. These protocols shall ensure that all assessments and information are kept in a secure location, only individuals designated by the Administrator have access and that assessment in whole or in part or information contained or derived from

such assessments shall not be available to anyone other than individuals designated by the Administrator.

The Conference substitute also provides that any individual

designated by the Administrator who acquires assessments or information derived from assessments and who knowingly or recklessly reveals such information other than to an individual designated by the Administrator shall be subject to up to 1 year imprisonment, or a fine in accordance with 16 U.S.C. 227 and shall

be removed from Federal office or employment unless the information is revealed for purposes of section 1445 of the Act, or actions

taken under section 1431 of the Act, or for use in any administrative or judicial proceeding to impose a penalty for failure to comply

with section 1433 of the bill. The substitute further provides that

an individual designated by the Administrator who is an employee

or officer of the United States may discuss the content of a vulnerability assessment submitted under this section with a State or

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local official. The Conference substitute provides that nothing authorizes any person to withhold any information from Congress.

The Conference substitute adds the requirement that each

community water system maintain a copy of the emergency response plan it has completed for 5 years after it certifies to the Administrator of the EPA that it has completed such plan. The Conference agreement also increases authorized funding for Fiscal

Year 2002 to $160 million and adds additional specification of basic

security enhancements. The Conference Agreement also extends

authorizations in this section through Fiscal Year 2005. Finally,

the Conference agreement provides that not more than $5,000,000

of the funds made available under the section may be used by the

Administrator of EPA for immediate and urgent security needs and

for grants for community water systems under 3,300 in accordance

with the guidance provided by EPA under the section.

Section 402. Other Safe Drinking Water Act Amendments

House provision: The House bill provides for a review of current and future methods to prevent, detect and respond to the intentional introduction of chemical, biological and radiological contaminants into community water systems and source water for

community water systems. This review is to encompass methods

and means to detect contaminants, to provide sufficient notice of

contamination, to prevent the flow of contaminated drinking water,

to negate or mitigate deleterious effects on public health and to

conduct biomedical research.

The House bill also provides for a review of methods and

means by which terrorists or other individuals or groups could disrupt the supply of safe drinking water or render a public water system significantly less safe for human consumption. The House bill

required a review of the methods and means by which pipes, constructed conveyances, collection, pretreatment, storage or distribution facilities could be destroyed or otherwise prevented from providing adequate supplies of drinking water and methods and

means by which they could be protected. The House bill also required a review of methods and means by which such items could

be subjected to cross-contamination and a review of methods and

means by which alternative supplies of water could be provided in

the event of destruction, impairment or contamination of public

water systems. The House bill authorized $15,000,000 in Fiscal

Year 2002 to carry out sections 1434 and 1435 and such sums as

may be necessary for Fiscal Years 2003 and 2004.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the

House provision with modifications. The Conference substitute includes further specification in section 1434 as to the detection of

various levels of contaminants and indicators of contaminants

using methods, means and equipment that include real time monitoring systems. The Conference substitute additionally requires

methods and means for developing education and awareness programs for community water systems.

The conference substitute also adds additional specification to

the reviews undertaken under section 1435 to include methods and

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means by which information systems, including process controls,

supervisory control and data acquisition and syber systems could

be disrupted by terrorists or other groups. The Conference substitute also includes additional requirements and considerations

that are applicable in the implementation of sections 1434 and

1435. These requirements and considerations include the assurance

that reviews reflect the needs of various community water system

sizes and geographical locations, the vulnerability of regions or

service areas, including the National Capital area, and that the Administrator of EPA disseminate certain information through the Information Sharing and Analysis Center. The Conference substitute

also provides such sums as may be necessary in Fiscal Year 2005.

Section 403. Miscellaneous and Technical Amendments

House provision: The House bill provides that section 1433 be

included as a cross-reference in section 1414(i)(1) on the Safe

Drinking Water Act (SDWA), that section 1431 of the SDWA be

amended, that existing penalties for tampering with drinking

water systems under section 1432 be increased and that section

1442 of the SDWA be amended to provide authorization for $35

million in Fiscal Year 2002 and such sums as may be necessary in

fiscal years thereafter.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The conference substitute adopts the

House provisions. The conferees encourage the committees of jurisdiction in the House and Senate to develop comparable legislation

covering publicly owned treatment works in this legislative session.

The conferees encourage EPA to work closely with organizations

representing small and rural water systems to implement the provisions of this Title.

TITLE V—ADDITIONAL PROVISIONS

The Managers agree to the following provisions.

Subtitle A—Prescription Drug User Fees

Section 501. Short Title

Designates the name of this title as the ‘‘Prescription Drug

User Fee Amendments of 2002.’’

Section 502. Findings

Declares the findings of Congress related to the reauthorization of prescription drug user fees.

Section 503. Definitions

The following terms in section 735 of the Federal Food, Drug,

and Cosmetic Act (FFD&C Act) (21 U.S.C. 379g) are modified by

this section: human drug application, prescription drug product,

process for the review of human drug applications, and adjustment

factor. These modifications are necessary to give effect to the

changes instituted by the reauthorization of the Prescription Drug

User Fee Act (PDUFA).

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The term ‘‘human drug application’’ is modified to make a technical correction.

The term ‘‘prescription drug product’’ is modified to allow the

Secretary to use the Prescription Drug Product List (the active portion) in the ‘‘Approved Drug Products with Therapeutic Equivalence Evaluations,’’ (the Orange Book) as the basis for identifying

which products should be considered to be prescription drug products for fee assessment purposes. The Managers expect that these

proposed changes will lead to a more efficient, less burdensome,

billing procedure. Under current law, any prescription drug product

eligible for drug listing is subject to product fees. Determining eligibility for listing is administratively complex and sometimes resource intensive. In addition, listing is often controlled by a repacker or distributor rather than by the sponsor, but the sponsor

must nonetheless pay the product fee. The Managers expect that

the use of the Orange Book, which is found on FDA’s Internet site,

as the basis to identify products for user fee assessment purposes

will not be construed to affect the legal status of the book or the

products in the book. The purpose of using this method is merely

a tool for the Secretary to provide a public, efficient billing process.

It also provides sponsors an easier way to remove products from

the list that is the basis for billing.

Also, the addition of the reference to the list of products approved under human drug applications under section 351 of the

Public Health Service Act created and maintained by the Secretary

refers to the current FDA method of identifying biological products

considered to be prescription drug products for fee assessment determinations. The Managers do not intend this to be a change in

practice; rather it documents FDA’s current practice. The list is to

be provided on FDA’s Internet site.

A further change to the term ‘‘prescription drug product’’ deletes the clause ‘‘does not include a large volume parenteral drug

product approved before September 1, 1992.’’ As a result, any large

volume parenteral (LVP) product is treated as a prescription drug

product and is subject to a fee. However, when coupled with a corresponding change proposed to section 736(a)(3)(B), all LVP’s would

be exempt from product fees in this reauthorization, including

products approved after September 1, 1992. The Managers intend

this change to decrease FDA’s administrative burden in determining which products should be billed.

The term ‘‘process for the review of human drug applications’’

is modified to allow the use of funds, for a period of up to three

years after approval, to cover risk management activities for products approved after October 1, 2002. This change is highly important to the Managers, as improving drug and biological product

safety is a goal shared by all.

The term ‘‘adjustment factor’’ is modified to eliminate obsolete

provisions.

Section 504. Authority to Assess and Use Drug Fees

Subsection (a) of this section allows fees authorized by the Act

to be assessed beginning on October 1, 2002. With respect to prescription drug establishment fees and prescription drug product

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fees, the subsection advances the date by which fees are payable

to October 1 of each year.

Under the second Prescription Drug User Fee Act (PDUFA),

prescription drug establishment and product fees, which represent

two-thirds of PDUFA fees were due January 31, four months into

the fiscal year. This necessitated carrying forward funds from a

previous year to sustain operations for the first four months of each

new fiscal year. By advancing the date for annual fees to be paid

to FDA, the necessity of carrying forward these large cash surpluses from year to year is eliminated. Also, by making this change

effective for FY 2003, FDA will have access to revenue as early in

FY 2003 as invoices can be issued and fees collected rather than

having to wait until January 31 to collect funds. This is especially

important for FDA operations in FY 2003 because the agency does

not expect to have any appreciable carryover funds at the end of

FY 2002.

Making the fee due and payable on October 1 necessitates

other changes to the FFD&C Act that are executed in subsection

(e) and (f) of this section.

This section sets forth a table containing the application, establishment, and product fee revenues, and total fee revenue, for

fiscal years 2003 through 2007. The subsection further authorizes

an increase in fee revenue amounts to fully fund the portion of additional costs attributable to the cost of the retirement of Federal

personnel. This provision would go into effect, if, after the enactment of the Prescription Drug User Fee Amendments of 2002, legislation is enacted requiring the Secretary to fund additional costs

of the retirement of Federal personnel.

This section also authorizes inflation adjustments, workload

adjustments, and a final year adjustment. Under present law, annual inflation adjustments were based on the higher of the federal

pay raise applicable for employees in the fiscal year for which the

fees were set or the CPI for the previous year. In order to collect

fees on October 1, FDA will have to set fees and issue invoices in

August of each year well before the pay-raise determination for the

next fiscal year is made. For this reason the inflation adjustment

factors have been changed to the Federal pay raise for employees

in the Washington, D.C., area for the previous fiscal year or the

change in the CPI for the 12 month period ending June 30, whichever is higher. Both of these figures will be available in August

when fees must be set. As has been the case in the past, these inflationary changes will continue to be cumulative and compounded.

Under the workload adjustment, annual revenue adjustments

are made that reflect changes in review workload, after inflation

adjustments. the workload adjustment is to be determined by the

Secretary based on a weighted average of the changes in the total

number of (1) human drug applications, (2) commercial investigational new drug applications, (3) efficacy supplements, and (4) manufacturing supplements. The subsection provides that the Secretary

shall publish in the Federal Register the fees resulting from this

adjustment and the supporting methodologies. Each of the 4 components used to develop the workload adjustment is a defined category of applications that FDA currently counts. Each component

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will be given a weighting factor that corresponds to its percent of

FDA review workload.

The workload adjustment envisioned for each component has

as its base the average number of applications of each particular

type that FDA received over the five-year period of current law. It

requires that a rolling average of submissions also be calculated

each year for the latest five-year period that ends on June 30 before the end of each fiscal year beginning on or after October 1,

2002. The percent change in the latest five-year average, compared

to the base year is then multiplied by the weighting factor for that

component. Then all four components of the workload adjuster are

added together and the total percent that results is the workload

adjuster that will be used to further adjust the inflation-adjusted

statutory revenue levels each year after FY 2003. Use of five year

rolling averages in this process dampens the impact of revenue

fluctuations—both up and down.

Under this section, the revenue adjuster will never result in

lower revenues than the inflation-adjusted statutory revenue levels. Nonetheless, in years when fee-paying applications fall below

projections, FDA will automatically experience a shortfall in revenues due to the shortfall in fee-paying applications. Further downward adjustment of the revenues would over-compensate for such

a decline in workload and is not authorized under the subsection.

This is a lesson learned from experience during 1998 through 2002.

If such a model had been in place for the past five years, revenues

during PDUFA II would have been much more predictable year to

year rather than exhibiting the volatility FDA experienced.

Also under this section, FDA is allowed to make a one-time increase in fees in FY 2007, if necessary, to assure that the agency

will have no less than three months of operating reserves on hand

at the end of FY 2007, when this legislation will expire. This final

year adjustment will allow the agency sufficient fees to operate for

up to 3 months in FY 2008 if there is any delay in the reauthorization of PDUFA at the end of FY 2007. Further, delaying this payment from industry until FY 2007 minimizes the need for FDA to

carry large balances over from year to year, reducing industry outlays until they are necessary to support operations.

Finally, this section provides that application, product, and establishment fees are to be established 60 days before the start of

the fiscal year based on the revenue amounts previously established in this section.

Under subsection (d), the waiver or fee reduction for supplements filed under section 505(b)(1) of the FFD&C Act is eliminated.

In this section the word ‘‘assessed’’ in section 736(f) of the

FFD&C Act has been changed to ‘‘retained.’’ This change is part of

a series of changes made to permit FDA to issue invoices and collect fees before an appropriation is actually made for the fiscal

year. The change maintains the original intent of this and related

provisions, however, by providing that the conditions originally

specified in these sections must be fulfilled once all appropriations

for the fiscal year, including any supplemental appropriations, are

enacted. If the conditions are not fulfilled, FDA may not retain the

fees it collects. Further, under this section, the word ‘‘collected’’ in

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section 736(g)(2)(A) of the FFD&C Act is changed to ‘‘retained.’’ Once again, this change is part of a series of changes made to permit FDA to issue invoices and collect fees before an appropriation

is actually made for the fiscal year. The change maintains the

original intent of this and related provisions by asserting that the

conditions originally specified in these sections must be fulfilled

once all appropriations for the fiscal year, including any supplemental appropriations, are enacted.

This section also responds to the problems associated with

FDA’s inability under the FFD&C Act to collect and spend fees in

any year that FDA fails to spend from appropriations as much as

it spent in FY 1997, adjusted for inflation. Failing to meet this obligation by as little as one dollar causes FDA to lose the authority

to collect application, product and establishment fees for a given

fiscal year. The consequence of failing to meet this ‘‘trigger’’ would

be catastrophic. Since the trigger is based on the amount FDA

spends, the agency can never identify exactly how much it has actually spent until after the end of the fiscal year. As a result, FDA

consistently overspends by a substantial amount to be certain that

FDA expenditures do not fall below the trigger amount and thereby

cause the agency to lose the authority to collect fees.

Modifications to section 736(g)(2)(B) are proposed to provide

FDA a margin of error in its effort to meet this requirement of the

law. This section is being modified so that if FDA’s spending is

within five percent of the amount required by this section of the

Act, the requirement of this section is considered to be satisfied. If

FDA under-spends by three percent or less, there are no consequences. If FDA under-spends by more than three percent but

not more than five percent, FDA will be required to reduce collections in the fiscal year following the subsequent fiscal year by the

amount in excess of three percent by which FDA under-spent from

appropriations. The intent is to relieve FDA of the need to overspend from appropriations each year, as it has done consistently

since 1993 to assure that this trigger is met. Spending from appropriations on the drug review process each year is still expected to

be at or very close to the amount specified by this trigger, and may

never be more than five percent below the trigger amount.

This section also authorizes appropriations for fiscal years

2003 through 2007 in amounts consistent with the total fee revenue amounts set forth in subsection (b).

Section 505. Accountability and Annual Reports

This section for the first time requires the agency to meet with

interested public and private stakeholders when considering the reauthorization of this program before its expiration. The Managers

believe that the agency will be in the best position to recognize

what best serves the public health by meeting with representatives

of consumer and patient advocacy groups, industry, the Congress,

health care professionals, and academic experts prior to the next

reauthorization of PDUFA. Further, the Managers believe that it

is very important for the agency to make any recommendations to

the Congress public, so this section requires that the FDA both

publish the recommendations, as well as hold a public hearing at

which time the agency can receive public feedback.

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This section also requires an annual Performance Report and

a Financial Report.

Section 506. Reports of Postmarketing Studies

Under this section, the Managers intend that in instances

wherein a study subject to the reporting requirements of Section

130 is not completed by the original or otherwise negotiated deadline agreed upon by the sponsor and if the reasons for such failure

to complete the study were not satisfactory to the Secretary, the

Secretary shall so note on the agency website. The Managers intend that the Secretary would not find the delay or termination of

a study unsatisfactory if the Secretary determined that the delay

or termination occurred through no fault of the sponsor (such as

ethical concerns, or the study is no longer needed).

This section also empowers the Secretary to require a sponsor

of a study required under section 505(b)(2)(A) or sections 314.510

or 601.41 of Title 21, Code of Federal Regulations, to notify health

care practitioners who prescribe such drugs or biological products

of the sponsor’s failure to complete the study, and the questions of

clinical benefit and, where appropriate, questions of safety, that remain unanswered as a result of such failure. The Managers intend

that this authority not be utilized in cases where, through no fault

of the sponsor (such as ethical concerns, or the study is no longer

needed), the study has been delayed or terminated.

Section 507. Savings Clause

This section authorizes user fees to be assessed and collected

after October 1, 2002 for human drug applications and supplements accepted for filing prior to October 1, 2002. For example, in

the event that application fees are owed but have not been collected prior to the expiration date for PDUFA II established by section 107 of the Food and Drug Administration Modernization Act

(FDAMA), the section will allow these fees to be collected after October 1, 2002. The section further authorizes assessment and collection of product and establishment fees after October 1, 2002 that

are owed but have not been collected.

Section 508. Effective Date

Section 508 provides that the Prescription Drug User Fee

Amendments of 2002 shall take effect October 1, 2002.

Section 509. Sunset Clause

Section 509 provides that the amendments made by sections

503 (relating to definitions) and 504 (relating to the authority to

assess and use drug fees) shall cease to be effective on October 1,

2007.

The section further provides that the amendments made by

section 505 (relating to annual reports) shall cease to be effective

120 days after October 1, 2007. The additional 120 days will allow

the prescription drug user fee reports for fiscal year 2007 to be prepared and submitted.

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Subtitle B—Additional Authorizations of Appropriations Regarding

Food and Drug Administration

Section 521. Office of Drug Safety

This section will help the FDA fulfill its vitally important role

of ensuring drug safety. The Managers are highly supportive of the

postmarket surveillance activities conducted by the Office of Drug

Safety (ODS), and to that end other provisions in this legislation

ensure for the first time that user fee monies will be available for

postmarket purposes. This section complements those efforts by ensuring that not only will new user fee monies be available for this

very important purpose, but so will new appropriated monies.

Section 522. Division of Drug Marketing, Advertising, and Communications

This section provides an increased authorization for the Division of Drug Marketing, Advertising, and Communications

(DDMAC) within the Office of Medical Policy, Center for Drug

Evaluation and Research at the FDA. DDMAC plays a vital role in

ensuring that promotional drug material is not false or misleading,

and they do so on a limited budget. The authorized amounts will

better ensure that DDMAC can perform its mission.

Section 523. Office of Generic Drugs

This section provides an increased authorization for the Office

of Generic Drugs (OGD) within the Center for Drug Evaluation and

Research at the FDA. OGD is vitally important to ensuring that

Americans have access to safe, effective generic drugs. This Office

needs increased funding, however, due to the fact that it presently

takes OGD nearly 18 months to review the typical ANDA. This section will lead to increased funding, so that these review times can

be decreased without compromising health and safety.

Subtitle C—Additional Provisions

Section 531. Transition to Digital Television

In an effort to further promote the orderly transition to digital

television, and to promote the equitable allocation and use of digital channels by television broadcast permittees and licensees, the

Managers direct the Federal Communications Commission, at the

request of an eligible licensee or permittee, to, within 90 days after

the date of enactment of this Act, allot, if necessary, and assign a

requested and identified paired digital television channel to that licensee or permittee. In order to avoid any undue burden to the

Commission, which is required to allot and assign the paired digital television channel within a short timeframe, the Managers expect all eligible applicants to file their applications as soon as practicable after the date of enactment. The FCC shall only do this if

such channel can be allotted and assigned without further modification of the tables of allotments as set forth in sections 73.606

and 73.622 of the Commission’s regulations (47 CFR 73.606,

73.622) and such allotment and assignment is consistent with the

Commission’s technical rules (47 CFR part 73). The only licensees

or permittees eligible for this digital allotment are those that are

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full power television broadcast licensee or permittees (or their successors in interest) that had an application pending for an analog

television station construction permit as of October 24, 1991, which

application was granted after April 3, 1997; and as of the date of

enactment of this Act, is the permittee or licensee of that station.

This provision enables such licensees or permittees an opportunity

to realize their expectations created by prior FCC action to foster

a digital audience during the transition period to digital television

without having to terminate abruptly analog service now enjoyed

by their viewers. Without this change, those broadcast licensees or

permittees would be denied the flexibility to operate an analog and

a digital facility simultaneously in the near term, especially in a

major market. This is contrary to the Congressional goals of increasing competition and accelerating the digital television transition. The Managers are ensuring that eligible licensees or permittees will meet the intended objectives by doing two important

things. First, the Managers impose an unequivocally hard 18-

month deadline for the construction of the digital facility from the

time of the FCC’s issuance of the construction permit for the new

digital channel. In this regard, eligible licensees are absolutely prohibited from obtaining or receiving an extension of time from the

Commission pursuant to 47 C.F.R. 73.624(d)(3). Second, the Managers safeguard against eligible licensees from using the newly

granted ‘‘in-core’’ digital channel allotment and assignment to provide analog service.

Section 532. 3-Year Delay in Lock-in Procedures for

Medicare+Choice Plans; Change in Medicare+Choice Reporting

Deadlines and Annual, Coordinated Election Period for 2003,

2004, and 2005

This section changes the deadline for Medicare+Choice plans to

submit information to the Secretary on Medicare benefits, premiums, cost sharing, supplemental benefits, and actuarial values of

such coverage from July 1 to the second Monday in September for

the years 2002, 2003, and 2004. It would also delay the annual

election period for Medicare enrollees to select a M+C plan to the

period of time beginning on November 15 and ending on December

31 in 2002, 2003, and 2004. This section also delays the phase-in

of the limitation on Medicare beneficiaries changing health plans

more than once a year (the ‘‘lock-in’’). This requirement, enacted in

the Balanced Budget Act of 1997, was scheduled to phase in incrementally beginning in 2002. The substitute would postpone the

lock-in requirements until 2005.

From the Committee on Energy and Commerce, for consideration of the House bill and the Senate amendment, and

modifications committed to conference:

BILLY TAUZIN,

MICHAEL BILIRAKIS,

PAUL E. GILLMOR,

RICHARD BURR,

JOHN SHIMKUS,

JOHN D. DINGELL,

HENRY A. WAXMAN,

SHERROD BROWN,

156

Provided that Mr. Pallone is appointed in lieu of Mr.

Brown of Ohio for consideration of title IV of the House

bill, and modifications committed to conference:

FRANK PALLONE, Jr.,

From the Committee on Agriculture, for consideration of

title II of the House bill and sec. 216 and title V of the

Senate amendment, and modifications committed to conference:

LARRY COMBEST, FRANK D. LUCAS, SAXBY CHAMBLISS, CHARLES STENHOLM, TIM HOLDEN, From the Committee on the Judiciary, for consideration of

title II of the House bill and secs. 216 and 401 of the Senate amendment, and modifications committed to conference:

F. JAMES SENSENBRENNER, Jr.,

LAMAR SMITH, JOHN CONYERS, Jr.,

Managers on the Part of the House.

EDWARD KENNEDY,

CHRIS DODD,

TOM HARKIN,

BARBARA A. MIKULSKI,

JIM JEFFORDS,

JUDD GREGG,

BILL FRIST,

MIKE ENZI,

TIM HUTCHINSON,

Managers on the Part of the Senate.

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