[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3457 Introduced in House (IH)]







107th CONGRESS
  1st Session
                                H. R. 3457

     To ensure the prompt research, development, manufacture, and 
 distribution of new lifesaving drugs, biologics, and medical devices 
that prevent or mitigate the consequences of a bioterrorist attack, and 
                          for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 11, 2001

 Mr. Schrock (for himself and Mr. Bartlett of Maryland) introduced the 
   following bill; which was referred to the Committee on Energy and 
  Commerce, and in addition to the Committee on the Judiciary, for a 
 period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the 
                          committee concerned

_______________________________________________________________________

                                 A BILL


 
     To ensure the prompt research, development, manufacture, and 
 distribution of new lifesaving drugs, biologics, and medical devices 
that prevent or mitigate the consequences of a bioterrorist attack, and 
                          for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pathogen Research, Emergency 
Preparedness, and Response Efforts Act of 2001'' or the ``PREPARE 
Act''.

SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

    The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by 
adding at the end the following:

``TITLE XXVIII--DEVELOPING NEW COUNTERMEASURES AND PROTECTING EXISTING 
                  COUNTERMEASURES AGAINST BIOTERRORISM

``SEC. 2801. DEVELOPMENT OF DRUGS, BIOLOGICAL PRODUCTS, AND MEDICAL 
              DEVICES TO COMBAT BIOTERRORISM.

    ``(a) Identification of Biological Agents or Toxins.--
            ``(1) In general.--The Secretary, in consultation with the 
        Secretary of Defense and the Attorney General, shall identify 
        biological agents or toxins that may be identified, prevented, 
        or treated through--
                    ``(A) the development of new covered products;
                    ``(B) the development of new uses, including 
                pediatric uses, for approved covered products; or
                    ``(C) the manufacture or distribution of covered 
                products that would otherwise not be manufactured or 
                distributed in sufficient quantities.
            ``(2) Publication and availability.--Not later than 180 
        days after the date of enactment of this title, and annually 
        thereafter, the Secretary shall publish in the Federal 
        Register, or otherwise make available to manufacturers or 
        potential manufacturers of covered products, a list of the 
        biological agents and toxins identified under paragraph (1) for 
        which the Secretary desires to encourage the development of, or 
        new uses for, covered products or the manufacture or 
        distribution of such covered products.
    ``(b) Consultation.--In carrying out this section, the Secretary 
shall consult with experts in the pharmaceutical, biotechnology, and 
medical device industries, academic medical centers, and research 
institutions, including those with pediatric expertise.
    ``(c) Limited Antitrust Exemption.--
            ``(1) Countermeasures development meetings.--
                    ``(A) Scheduling countermeasures development 
                meetings.--The antitrust laws shall not apply to 
                meetings or consultations conducted by the Secretary 
                with parties involved in the development of 
                countermeasures for the purpose of the development, 
                manufacture, distribution, and sale of countermeasures 
                that are prioritized under section 2801(a), consistent 
                with the purposes of this title. The Secretary shall 
                give notice to the Assistant Attorney General of 
                Antitrust of meetings scheduled pursuant to this 
                subsection.
                    ``(B) Meeting conditions.--Any meeting under 
                subparagraph (A)--
                            ``(i) shall be chaired by the Secretary;
                            ``(ii) shall be open to parties involved in 
                        the development of countermeasures, as 
                        determined by the Secretary;
                            ``(iii) shall be open to the Attorney 
                        General and the Federal Trade Commission;
                            ``(iv) shall be limited to discussions 
                        involving the development, manufacture, 
                        distribution, or sale of countermeasures that 
                        are prioritized under section 2801(a); and
                            ``(v) shall be conducted in such manner as 
                        to ensure that national security, confidential, 
                        and proprietary information is not disclosed 
                        outside the meeting.
                    ``(C) Minutes.--The Secretary shall ensure that 
                minutes of the meeting are maintained.
            ``(2) Applying for limited exemption.--
                    ``(A) Filing procedures.--As a result of meetings 
                under paragraph (1), the Secretary and participating 
                parties may file a written request with the Attorney 
                General for a limited exemption from the antitrust laws 
                to allow appropriate parties to enter into agreements 
                or engage in conduct relating to the development, 
                manufacture, distribution, or sale of countermeasures 
                prioritized under section 2801(a). Any such request 
                shall set forth the intended purpose of the agreement, 
                including an explanation as to why a cooperative effort 
                among potential competitors is necessary to achieve the 
                objective of the agreement. The request shall state 
                with specificity the substance of the agreement, the 
                methods that will be utilized to achieve the objectives 
                of the agreement, and any other relevant information 
                relating to the development and production of 
                countermeasures that are prioritized under section 
                2801(a).
                    ``(B) Grant of exemption.--Not later than 60 days 
                after receipt of a request filed pursuant to 
                subparagraph (A), the Attorney General, in consultation 
                with the Chairman of the Federal Trade Commission shall 
                make a determination to grant, deny, grant in part and 
                deny in part, or propose modifications to any request 
                made pursuant to subparagraph (A) for exemption from 
                the antitrust laws. In making the determination, the 
                Attorney General shall consider factors including the 
                following:
                            ``(i) Whether such agreement would promote 
                        the purposes of this title.
                            ``(ii) Whether the exemption from the 
                        antitrust laws would promote the public 
                        interest.
                            ``(iii) The competitive impact to areas not 
                        directly related to the development and 
                        production of countermeasures prioritized under 
                        section 2801(a).
                    ``(C) Sunset.--The authority of the Attorney 
                General to grant a limited antitrust exemption under 
                this section expires at the end of the 2-year period 
                beginning on the date of enactment of the Pathogen 
                Research, Emergency Preparedness, and Response Efforts 
                Act of 2001.

``SEC. 2802. CONTRACTS FOR DEVELOPMENT OF COVERED PRODUCTS.

    ``(a) Authority.--The Secretary may enter into contracts and 
cooperative research and development agreements pursuant to section 
11(a) of the Stevenson-Wydler Technology Innovation Act of 1980 (15 
U.S.C. 3710(a)), material transfer agreements, or other agreements, or 
agree to the amendment or modification of existing or future contracts 
or agreements, for the development, manufacture or distribution of 
covered products for uses or new uses identified by the Secretary 
pursuant to section 2801(a). A contract or agreement entered into, or 
amended or modified, under this subsection may address 1 or more 
aspects of the development, manufacture, or distribution of 1 or more 
uses of 1 or more covered products. Such contracts or agreements may 
set forth guaranteed minimum quantities of products and negotiated unit 
prices.
    ``(b) Timing of Contract.--Notwithstanding any other provision of 
law, the Secretary may enter into a contract or agreement under 
subsection (a) even before the development, approval, or clearance of 
the covered product that is the subject of the contract or agreement. 
Such contract or agreement may provide for the termination of the 
contract or agreement for the convenience of the Government if the 
contractor fails to develop the covered product involved.
    ``(c) Payments.--Payments under a contract or agreement under 
subsection (a) may be made from--
            ``(1) funds obligated for the performance of the contract 
        or agreement involved;
            ``(2) funds available for the development, manufacture, 
        distribution, or purchase of covered products for uses referred 
        to in section 2801(a); or
            ``(3) any other funds available to the Secretary.
    ``(d) Contracts.--In administering the provisions of this section, 
the Secretary may enter into contracts in advance of appropriations and 
incur obligations without regard to provisions of law relating to 
contracts, including sections 1341, 1342, 1349, 1350, and 1351, and 
subchapter II of chapter 15, of title 31, United States Code.

``SEC. 2803. INDEMNIFICATION.

    ``The Secretary shall, in any contract or agreement for the 
manufacture, development, distribution, or the purchase of a covered 
product intended for a use identified by the Secretary pursuant to 
section 2801(a), indemnify and hold harmless the contractor consistent 
with the following principles:
            ``(1) Uses covered.--Indemnification only extends to uses 
        of the covered product pursuant to a contract entered into by 
        the Secretary under section 2802.
            ``(2) Entities covered.--The Secretary may indemnify 
        contractors, subcontractors, distributors, persons who 
        administer covered products, or other parties as determined 
        appropriate by the Secretary pursuant to contracts entered into 
        under section 2802.
            ``(3) Limits.--No indemnification shall be provided for 
        intentional torts by the contractor or torts by the contractor 
        involving gross negligence or recklessness.

``SEC. 2804. HIGH QUALITY PRODUCTION.

    ``The Secretary may, with the agreement of the manufacturer of a 
drug, biological product, or medical device that is approved, licensed, 
or cleared (or awaiting approval, licensure, or clearance) under 
section 505, 510, 513, or 515 of the Federal Food, Drug, and Cosmetic 
Act, or section 351 of this Act, and is a covered product, provide 
intensive assistance, including on-site assistance, when necessary, in 
order to facilitate prompt compliance with good manufacturing practice 
regulations under sections 210, 211, 225, 226, 600, 601, 606, or 820 of 
title 21, Code of Federal Regulations, in the manufacturing, 
processing, packing, or holding of the drug, biological product, or 
medical device.

``SEC. 2805. SECURITY FOR RESEARCH AND PRODUCTION.

    ``(a) In General.--The Secretary, in consultation with the Attorney 
General and the Secretary of Defense, may award grants and contracts, 
enter into cooperative agreements, and provide technical or nonmonetary 
assistance, to provide security to facilities that conduct research and 
development, production, distribution, and storage of covered products.
    ``(b) Best Practices.--The Secretary shall develop guidelines and 
best practices to enable entities eligible for funding under this 
section to secure their facilities against potential bioterrorist 
attack.

``SEC. 2806. MOBILITY OF STOCKPILE.

    ``(a) Special Events.--In managing the National Pharmaceutical 
Stockpile, the Secretary, in consultation with State and local 
government officials, shall take into consideration the timing and 
location of special events, including designated national security 
events.
    ``(b) Location of Certain Stocks.--In carrying out subsection (a), 
the Secretary shall ensure that medical supplies from the National 
Pharmaceutical Stockpile are located in appropriate proximity to the 
site of the special event.

``SEC. 2807. DEFINITIONS.

    ``In this title:
            ``(1) Antitrust laws.--The term `antitrust laws'--
                    ``(A) has the meaning given such term in subsection 
                (a) of section 1 of the Clayton Act (15 U.S.C. 12(a)), 
                except that such term includes section 5 of the Federal 
                Trade Commission Act (15 U.S.C. 45) to the extent such 
                section 5 applies to unfair methods of competition; and
                    ``(B) includes any State law similar to the laws 
                referred to in subparagraph (A).
            ``(2) Biological agents or toxins.--The terms `biological 
        agent' and `toxin' have the meanings given such terms in 
        section 178 of title 18, United States Code.
            ``(3) Covered products.--The term `covered products' 
        includes drugs, biological products including vaccines, and 
        medical devices including in vitro diagnostics, that may be 
        developed or produced to identify, prevent, or treat disease or 
        harm in humans, including children and other vulnerable 
        populations, resulting from an attack or threatened attack 
        using biological agents or toxins.
            ``(4) Development.--The term `development' includes the 
        identification of suitable compounds or biological materials, 
        the conduct of preclinical and clinical studies, the 
        preparation of an application for marketing approval or 
        clearance, the conduct of postmarket or postapproval studies, 
        and any other actions related to preparation of a covered 
        product.''.

SEC. 3. EXPEDITING FDA REVIEW AND APPROVAL.

    (a) Amendment.--Section 506 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356) is amended by adding at the end the following:
    ``(e) Biological Agents or Toxins.--
            ``(1) In general.--The Secretary may designate an 
        unapproved covered product identified pursuant to section 
        2801(a) of the Public Health Service Act as a fast-track 
        product pursuant to this section. Such a designation may be 
        made before the submission of--
                    ``(A) a request for designation by the sponsor; or
                    ``(B) an application for the investigation of the 
                drug under section 505(i) or section 351(a)(3) of the 
                Public Health Service Act.
            ``(2) Use of animal trials.--An application for a drug for 
        which approval is sought on the basis of evidence of 
        effectiveness that is derived from animal studies under the 
        last sentence of section 505(d) or section 351(a)(1) of the 
        Public Health Service Act may be designated as a fast-track 
        product for purposes of this section.''.
    (b) Review.--The Secretary shall grant priority review to a 
submission for a covered product, unless the sponsor has filed an 
application for review of the product under section 506 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356).

SEC. 4. USE OF ANIMAL TRIALS IN THE APPROVAL OF COVERED PRODUCTS.

    (a) New Drugs.--Section 505(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(d)) is amended by adding at the end the 
following: ``In the case of drugs for use against a potentially lethal 
or permanently disabling toxic biological agent or toxin, when adequate 
and well-controlled studies in humans cannot ethically be conducted 
because the studies would involve administering such an agent or toxin 
to healthy human volunteers without a proven treatment, and when 
adequate field trials assessing the use of the drug (in situations such 
as after accidental or hostile exposure to the substance) have not been 
feasible, the Secretary may grant approval, including approval for 
pediatric populations, based on evidence derived from appropriate 
studies in animals or other information. The Secretary may use 
authority under section 506 or other relevant provisions to order 
postmarketing approval studies. Drugs approved solely under the 
authority of the preceding two sentences shall be for purposes of 
identifying, treating, or preventing infection, disease, injury, or 
other health condition or consequence resulting from a disabling toxic 
chemical, biological, radiological, or nuclear attack or potential 
attack, or other significant disease emergency as the Secretary may 
determine appropriate.''.
    (b) New Biological Products.--Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended by adding at the end the 
following:
    ``(k) Approval of Certain Products Based on Animal Trials.--
            ``(1) In general.--In the case of biological products for 
        use against a potentially lethal or permanently disabling toxic 
        chemical, biological, radiological, nuclear, or other agent or 
        toxins, when adequate and well-controlled studies in humans 
        cannot ethically be conducted because the studies would involve 
        administering such an agent or toxin to human volunteers 
        without a proven treatment, and when adequate field trials 
        assessing the use of the biological product (in situations such 
        as after accidental or hostile exposure to the substance) have 
        not been feasible, the Secretary may grant approval, including 
        approval for pediatric populations, based on evidence derived 
        from appropriate studies in animals or other information.
            ``(2) Postmarketing approval studies.--With respect to 
        products described in paragraph (1), the Secretary may use 
        authority under section 506 of the Federal Food, Drug, and 
        Cosmetic Act to order postmarketing approval studies.
            ``(3) Limitations.--Biological products approved solely 
        under the authority of this subsection shall be for purposes of 
        identifying, treating, or preventing infection, disease, 
        injury, or other health condition or consequence resulting from 
        a potentially disabling toxic chemical, biological, 
        radiological, or nuclear attack or potential attack, or other 
        significant disease emergency as the Secretary may determine 
        appropriate.''.
    (c) Final Rule.--Not later than 60 days after the date of enactment 
of the Pathogen Research, Emergency Preparedness, and Response Efforts 
Act of 2001, the Secretary shall finalize the proposed rule published 
on October 5, 1999, regarding the use of animal trials in the approval 
of products.

SEC. 5. BIOLOGICAL AGENTS AND TOXINS.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the 
following:

               Subchapter E--Biological Agents and Toxins

``SEC. 570. AUTHORITY TO RESTRICT TRANSPORTATION AND USE.

    ``(a) In General.--The Secretary shall undertake a program that, 
through inspections and other containment procedures, will prohibit the 
unauthorized shipment or transportation in interstate or foreign 
commerce, the possession or other use in or affecting commerce, or 
assistance to another person in such transportation, shipment, or other 
use by any person of biological agents or toxins, or the receipt of 
biological agents or toxins so shipped or transported.
    ``(b) Definitions.--In this section:
            ``(1) Biological agents and toxins.--The terms `biological 
        agent' and `toxin' have the meanings given such terms in 
        section 2807 of the Public Health Service Act and refer to a 
        biological agent or toxin listed as a `select agent' in section 
        72.6(j) of title 42, Code of Federal Regulations, which is not 
        exempt under section 72.6(h) or appendix A of such title and 
        which does not include any such biological agent or toxin that 
        is in its naturally occurring environment and that has not been 
        cultivated, collected, or otherwise extracted from its natural 
        source.
            ``(2) Person.--The term `person' includes an alien (other 
        than an alien admitted for permanent residence) who is a 
        national of a country as to which the Secretary of State has 
        made a determination (that is in effect) that such country has 
        repeatedly provided support for acts of international 
        terrorism.''.
    (b) Enforcement.--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 shipment, transportation, possession, or other use, 
assistance with respect to, or receipt of a biological agent or toxin 
in violation of section 570.''.

SEC. 6. REGULATION OF BIOLOGICAL AGENTS AND TOXINS POSING POTENTIAL 
              NATIONAL SECURITY THREAT.

    (a) Redesignation and Clarification of Biological Agents; 
Regulatory Provisions of Antiterrorism and Effective Death Penalty Act 
of 1996.--
            (1) In general.--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 BIOLOGICAL AGENTS AND TOXINS.

    ``(a) Regulatory Control of Biological Agents and Toxins.--
            ``(1) List of biological agents and toxins.--The Secretary 
        shall, through regulations promulgated under subsection (c), 
        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.
            ``(2) Criteria.--In determining whether to include an agent 
        or toxin on the list under subsection (a), the Secretary 
        shall--
                    ``(A) 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 
                        or prevent any illness resulting from infection 
                        by the agent or toxin; and
                            ``(iv) any other criteria that the 
                        Secretary considers appropriate; and
                    ``(B) consult with scientific experts representing 
                appropriate professional groups.
    ``(b) Regulation of Transfers of Listed Biological Agents and 
Toxins.--The Secretary shall, through regulations promulgated under 
subsection (c), provide for--
            ``(1) the establishment and enforcement of safety 
        procedures for the transfer of biological agents and toxins 
        listed pursuant to subsection (a)(1), 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 of safeguards 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 
        in the event of a transfer or potential transfer of a 
        biological agent or toxin in violation of the safety procedures 
        established under paragraph (1) or the safeguards established 
        under paragraph (2); and
            ``(4) appropriate availability of biological agents and 
        toxins for research, education, and other legitimate purposes.
    ``(c) Regulations.--The Secretary shall promulgate regulations to 
carry out this section.
    ``(d) Definitions.--For purposes of this section and section 351B, 
the terms `biological agent' and `toxin' have the meanings given such 
term in section 2807.''.
            (2) 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.
            (3) Effective date.--The amendments made by this subsection 
        shall take effect as if incorporated in the Antiterrorism and 
        Effective Death Penalty Act of 1996.
    (b) Regulation of Biological Agents and Toxins Posing Potential 
National Security Threat.--
            (1) In general.--Part F of title III of the Public Health 
        Service Act (42 U.S.C. 262 et seq.), as amended by subsection 
        (a)(1), is further amended by inserting after section 351A the 
        following:

``SEC. 351B. REGULATION OF BIOLOGICAL AGENTS AND TOXINS POSING 
              POTENTIAL NATIONAL SECURITY THREAT.

    ``(a) In General.--
            ``(1) List of biological agents and toxins posing national 
        security threat.--The Secretary shall, through regulations 
        promulgated under subsection (d), establish and maintain a list 
        of those biological agents and toxins listed pursuant to 
        section 351A(a)(1) that the Secretary determines to be a 
        potential national security threat.
            ``(2) Criteria.--In determining whether to include an agent 
        or toxin on the list under subsection (a), the Secretary 
        shall--
                    ``(A) consider the criteria specified in section 
                351A(a)(2)(A), and any other criteria that the 
                Secretary considers appropriate; and
                    ``(B) consult with scientific, intelligence, and 
                military experts representing appropriate professional 
                groups.
    ``(b) Regulation of Transfers of Listed Biological Agents and 
Toxins.--The Secretary shall, through regulations promulgated under 
subsection (d), provide for the establishment and enforcement of 
standards and procedures governing the possession, use, and transfer of 
biological agents and toxins listed pursuant to subsection (a)(1) that 
are designed to protect public safety and national security, including 
safeguards to prevent access to such agents and toxins for use in 
domestic or international terrorism or for any other criminal purpose.
    ``(c) Civil Money Penalties.--A violation of a requirement imposed 
by a regulation promulgated under this section shall be subject, in 
addition to any other applicable civil or criminal sanctions, to a 
civil money penalty in an amount not to exceed $250,000.
    ``(d) Regulations.--The Secretary shall promulgate regulations to 
carry out this section.
    ``(e) Freedom of Information Act Exemption.--Any information 
provided to the Secretary pursuant to regulations issued under 
subsection (d) or under section 351A(c) shall not be disclosed under 
section 552 of title 5, United States Code.''.
            (2) Effective date.--The amendment made by this subsection 
        shall take effect as if incorporated in the Antiterrorism and 
        Effective Death Penalty Act of 1996.

SEC. 7. ADMINISTRATION.

    In administering the provisions of this Act, the Secretary of 
Health and Human Services shall--
            (1) continue to recognize and honor rights relating to 
        patents, data, and copyrights; and
            (2) comply with all applicable provisions of the 
        regulations relating to Federal acquisition, the Federal Trade 
        Secrets Act, and all other laws protecting confidential 
        commercial information, trade secrets, and intellectual 
        property rights, and patent and nonpatent market exclusivity 
        rights.

SEC. 8. COORDINATION OF EFFORTS TO PROTECT AGAINST BIOTERRORISM.

    The Secretary of Health and Human Services and the Secretary of 
Defense shall coordinate in the planning, design, and construction of a 
Department of Defense Government-owned, contractor-operated vaccine 
production facility on a military installation, as appropriate.

SEC. 9. ENHANCEMENT OF PENALTIES FOR ANIMAL ENTERPRISE TERRORISM.

    Section 43 of title 18, United States Code, is amended--
            (1) in subsection (a), by striking ``one year'' and 
        inserting ``5 years'';
            (2) in subsection (b)--
                    (A) by redesignating paragraph (2) as paragraph 
                (3);
                    (B) by inserting after paragraph (1) the following:
            ``(2)  Explosives or arson.--Whoever in the course of a 
        violation of subsection (a) maliciously damages or destroys, or 
        attempts to damage or destroy, by means of fire or an 
        explosive, any building, vehicle, or other real or personal 
        property used by the animal enterprise shall be imprisoned for 
        not less than 5 years and not more than 20 years, fined under 
        this title, or both.''; and
                    (C) in paragraph (3), as so redesignated, by 
                striking ``under this title and'' and all that follows 
                through the period and inserting ``under this title and 
                imprisoned for life or for any term of years.''; and
            (3) in subsection (c)--
                    (A) by striking ``and'' at the end of paragraph 
                (1);
                    (B) by striking the period at the end of paragraph 
                (2) and inserting ``; and''; and
                    (C) by adding at the end the following:
            ``(3) for any other economic damage resulting from the 
        violation of this section.''.
                                 <all>