[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3154 Introduced in House (IH)]






109th CONGRESS
  1st Session
                                H. R. 3154

   To provide incentives for pharmaceutical companies, biotechnology 
   companies, and medical device companies to invest in research and 
 development with respect to antibiotic drugs, antivirals, diagnostic 
tests, and vaccines that may be used to identify, treat, or prevent an 
              infectious disease, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 30, 2005

   Mrs. Cubin (for herself, Mr. Baird, Mr. Matheson, Mr. Baker, Mr. 
 LaHood, Mr. Bonner, Mr. Davis of Alabama, Mr. Gingrey, and Mr. Weldon 
 of Florida) introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
   the Judiciary and Ways and Means, 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 provide incentives for pharmaceutical companies, biotechnology 
   companies, and medical device companies to invest in research and 
 development with respect to antibiotic drugs, antivirals, diagnostic 
tests, and vaccines that may be used to identify, treat, or prevent an 
              infectious disease, 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 ``Infectious Diseases Research and 
Development Act of 2005''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Infections caused by resistant bacteria can strike 
        anyone, including the young and the old, the healthy and the 
        chronically ill. Antibiotic resistance is a particularly 
        serious problem for patients whose immune systems are 
        compromised, such as people with HIV/AIDS and patients in 
        critical care units.
            (2) About 2 million people acquire bacterial infections in 
        United States hospitals each year, and 90,000 die as a result. 
        About 70 percent of those infections are resistant to at least 
        one drug. The trends toward increasing numbers of infection and 
        increasing drug resistance show no sign of abating.
            (3) Resistant pathogens lead to higher health care costs 
        because they often require more expensive drugs and extended 
        hospital stays. The total cost to United States society is 
        nearly $5,000,000,000 annually.
            (4) The Institute of Medicine, the Infectious Diseases 
        Society of America, and Federal officials have identified 
        antibiotic resistance and the dearth of antibiotic research and 
        development as increasing threats to United States public 
        health.
            (5) Without innovative public policy and additional 
        financial support, fewer and fewer antibiotics will be 
        available to treat the increasing number of drug-resistant and 
        dangerous microbes that threaten Americans and the global 
        community.
            (6) The pipeline of new antibiotics is drying up. Major 
        pharmaceutical companies are losing interest in the antibiotics 
        market because these drugs simply are not as profitable as 
        drugs that treat chronic (long-term) conditions and lifestyle 
        issues.
            (7) Drug research and development is expensive, risky, and 
        time-consuming. An aggressive research and development program 
        initiated today would likely require 10 or more years and an 
        investment of $800,000,000 to $1,700,000,000 to bring a new 
        drug to market.
            (8) Resistant bacterial infections are not only a public 
        health problem; they have national and global security 
        implications as well.
            (9) The Institute of Medicine in its 2004 report entitled 
        ``The Threat of Pandemic Influenza'' stated that the United 
        States is not adequately prepared to deal with the next 
        pandemic of influenza.
            (10) The Centers for Disease Control and Prevention 
        estimates that, without adequate preparation, 100,000 to 
        250,000 deaths could occur in the United States from a mild 
        pandemic of influenza.
            (11) The limited influenza vaccine market and few dedicated 
        manufacturers pose a substantial challenge to the Nation's 
        preparedness efforts. Currently, there are two manufacturers of 
        influenza vaccine for the United States market. In 2004, the 
        Food and Drug Administration suspended a manufacturer's license 
        due to bacterial contamination. This action led to a shortage 
        of injectable influenza vaccine in the United States.
            (12) New rapid diagnostics would greatly reduce the cost 
        and time needed to conduct clinical trials for new anti-
        infectives. For many infectious diseases, there currently are 
        no rapid diagnostic tests available to assist in identifying 
        eligible patients for clinical trials. Cutting costs and time 
        will serve as incentives for greater investment in this area. 
        In addition, new rapid diagnostics will permit physicians to 
        diagnose specific bacterial infections in their patients. This 
        will enable physicians to prescribe the most appropriate 
        therapies, including antibiotics, which will slow the evolution 
        of new antimicrobial resistance.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) The term ``antibiotic drug'' has the meaning given to 
        that term in section 201 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 321).
            (2) The term ``antiviral'' means a drug or biological 
        product intended for human use that impedes the reproduction of 
        a virus.
            (3) The term ``biological product'' has the meaning given 
        to that term in section 351 of the Public Health Service Act 
        (42 U.S.C. 262).
            (4) The term ``device'' has the meaning given to that term 
        in section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321).
            (5) The term ``diagnostic test'' means a device or product 
        used to detect the presence, concentration, or characteristics 
        of an infectious human disease.
            (6) The term ``drug'' has the meaning given to that term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321).
            (7) The term ``qualified infectious disease product'' means 
        any antibiotic drug, antiviral, diagnostic test, or vaccine 
        that is developed for the purpose of treating, detecting, 
        preventing, or identifying--
                    (A) a qualifying pathogen (for the period beginning 
                on the date of the enactment of this Act and ending on 
                commencement of the period described in subparagraph 
                (B)); or
                    (B) an infectious pathogen identified by the 
                Commission under section 319E-1(b) of the Public Health 
                Service Act, as added by section 10 of this Act (for 
                the period beginning on the date on which the 
                Commission on Infectious Diseases Product Development 
                first identifies infectious pathogens under such 
                section).
            (8) The term ``qualifying pathogen'' means--
                    (A) community-acquired methicillin-resistant 
                staphylococcus areus (CA-MRSA);
                    (B) life-threatening gram negative bacteria, such 
                as Escherichia coli (E. coli), Acinetobacter, 
                Klebsiella species, and Pseudomonas aeruginosa;
                    (C) influenza; or
                    (D) any other infectious pathogen identified for 
                purposes of this Act by the Secretary of Health and 
                Human Services, in concurrence with infectious disease 
                clinicians and appropriate professional associations, 
                as a significant threat to public health because of 
                drug resistance or other factors (or likely to become 
                such a threat).
            (9) The term ``vaccine'' means a vaccine intended for human 
        use.

SEC. 4. LIABILITY PROTECTION.

    (a) Applicability.--This section applies when--
            (1) an individual is injured or dies as the result of a use 
        or misuse of a qualified infectious disease product (other than 
        a vaccine);
            (2) a person is entitled, by reason of such injury or 
        death, to recover damages from a manufacturer of the product; 
        and
            (3) such manufacturer was, as of the date of such injury or 
        death, in substantial compliance with all applicable Federal 
        requirements with respect to the product.
    (b) Federal Action Required.--The district courts of the United 
States shall have jurisdiction over a civil action covered by 
subsection (a). Such a civil action may not be brought in any Federal, 
State, or local court other than a district court of the United States.
    (c) Limitation on Punitive Damages.--In a civil action covered by 
subsection (a), the person may recover punitive damages from the 
manufacturer to the extent otherwise available by law, except that--
            (1) it must be proven, in addition to any other matter that 
        must be proven, that the manufacturer--
                    (A) acted with malicious intent to injure the 
                individual; or
                    (B) deliberately failed to avoid unnecessary injury 
                that the manufacturer knew the individual was 
                substantially certain to suffer; and
            (2) the person may not recover punitive damages from the 
        manufacturer if the person does not recover compensatory 
        damages from the manufacturer.
    (d) Limitation on Non-Economic Damages.--In a civil action covered 
by subsection (a), the person may recover non-economic damages from the 
manufacturer to the extent otherwise available by law, except that the 
amount of such damages may not exceed $250,000.

SEC. 5. PATENT PROTECTION.

    (a) Purpose.--The purpose of this section is to provide an 
incentive for research and development relating to qualified infectious 
disease products.
    (b) Restoration of Patent Terms.--
            (1) In general.--Chapter 14 of title 35, United States 
        Code, is amended by inserting after section 156 the following:

``SEC. 156A. RESTORATION OF PATENT TERMS RELATING TO QUALIFIED 
              INFECTIOUS DISEASE PRODUCTS.

    ``(a) Definitions.--In this section--
            ``(1) the term `diagnostic test' has the meaning given to 
        that term in section 3 of the Infectious Diseases Research and 
        Development Act of 2005;
            ``(2) the term `qualified infectious disease product' has 
        the meaning given to that term in section 3 of the Infectious 
        Diseases Research and Development Act of 2005;
            ``(3) the term `regulatory review period' means the period 
        of time that--
                    ``(A) starts on the date that is the later of--
                            ``(i) the date that an eligible patent 
                        sought to be extended under this section is 
                        issued;
                            ``(ii) the date that an exemption under 
                        section 505(i) of the Federal Food, Drug, and 
                        Cosmetic Act became effective for the product; 
                        or
                            ``(iii) the date on which an 
                        investigational device exemption is approved 
                        pursuant to section 520(g) of the Federal Food, 
                        Drug and Cosmetic Act; and
                    ``(B) ends on the date that is--
                            ``(i) in the case of a drug, the date on 
                        which an application submitted for such drug 
                        under section 505(b) of the Federal Food, Drug, 
                        and Cosmetic Act is approved;
                            ``(ii) in the case of a biologic, the date 
                        on which an application submitted under section 
                        351 of the Public Health Service Act is 
                        approved; or
                            ``(iii) in the case of a medical device, 
                        the date on which an application for premarket 
                        approval submitted for such device under the 
                        Federal Food, Drug, and Cosmetic Act is 
                        approved; and
            ``(4) the term `eligible patent' means a patent that--
                    ``(A) claims a qualified infectious disease 
                product, or claims an active ingredient of such 
                product, or a process of making or using the product or 
                an active ingredient of such product; and
                    ``(B) is owned by or licensed to an entity that 
                sponsored the application described in paragraph (3)(B) 
                for the product.
    ``(b) Patent Term Extension.--The term of an eligible patent shall 
be extended from the expiration date of the patent that would otherwise 
apply, which shall include any patent term adjustment granted under 
section 154(b), by a period equal to the number of days in the 
regulatory review period if each of the following is met:
            ``(1) An application in conformance with the requirements 
        of subsection (c) is submitted to the Director by either the 
        owner of record of the patent or its agent by the later of 60 
        days after the end of the regulatory review period or 45 days 
        after issuance of the patent.
            ``(2) The patent that is the basis of the application has 
        not been previously extended under this section, or under 
        section 156.
            ``(3) The term of the patent that is the basis of the 
        application has not expired before the date that the 
        application is submitted under subsection (c).
            ``(4) The regulatory review period for the qualified 
        infectious disease product has not been relied upon to support 
        an application to extend the term of another patent under this 
        section or under section 156.
    ``(c) Administrative Provisions.--
            ``(1) In general.--To obtain an extension of the term of a 
        patent under this section, the owner of record of the patent or 
        its agent shall submit an application to the Director.
            ``(2) Content.--The application shall contain--
                    ``(A) a description of the qualified infectious 
                disease product and the Federal statute under which 
                regulatory review occurred;
                    ``(B) the identity of the patent for which an 
                extension is sought under this section; and
                    ``(C) such other information as the Director may 
                require including to establish that the applicant meets 
                the requirements of this section.
            ``(3) Irrevocable election.--The submission of an 
        application under this section is an irrevocable election of 
        the application of this section to the patent that is the basis 
        of the application. A patent that has been the basis of an 
        application made under this section may not be the subject of 
        an application made under section 156 or 158.''.
            (2) Technical and conforming amendment.--The table of 
        sections for chapter 14 of title 35, United States Code, is 
        amended by inserting after the item relating to section 156 the 
        following:

``156a. Restoration of patent terms relating to qualified infectious 
                            disease products.''.
    (c) Extension of Patent Terms.--
            (1) Certification of successful development.--
                    (A) Application.--An entity may submit to the 
                Secretary of Health and Human Services (in this section 
                referred to as the ``Secretary'') an application for 
                certification that the entity--
                            (i) has successfully developed a qualified 
                        infectious disease prevention product, as that 
                        term is defined in section 158 of title 35, 
                        United States Code; and
                            (ii) the entity may receive a patent term 
                        extension under the provisions of such section.
                    (B) Certification.--With respect to an application 
                submitted by an entity under this paragraph, the 
                Secretary shall--
                            (i) approve the application if the 
                        Secretary determines that the entity has 
                        successfully developed the qualified infectious 
                        disease prevention product;
                            (ii) deny the application if the Secretary 
                        determines that the entity has not successfully 
                        developed the product; and
                            (iii) notify the entity of the approval or 
                        denial, and the reasons therefore.
                    (C) Successful development.--In carrying out 
                subparagraph (B), the Secretary shall determine that an 
                entity has successfully developed a product if--
                            (i) the product is a qualified infectious 
                        disease prevention product; and
                            (ii) the product has been approved under 
                        section 505 or 515 of the Federal Food, Drug, 
                        and Cosmetic Act or section 351 of the Public 
                        Health Service Act.
                    (D) Effect of certification.--If the Secretary 
                approves an application submitted by an entity under 
                this paragraph, the entity may use the patent extension 
                provisions of section 158 of title 35, United States 
                Code.
                    (E) Application.--This paragraph and the amendment 
                made by paragraph (2) apply only with respect to a 
                product that is approved under section 505 or 515 of 
                the Federal Food, Drug, and Cosmetic Act or section 351 
                of the Public Health Service Act after the date of the 
                enactment of this Act.
            (2) In general.--Chapter 14 of title 35, United States 
        Code, is amended by adding at the end the following:
``Sec. 158. Extension of patent terms relating to qualified infectious 
              disease prevention products.
    ``(a) Definitions.--In this section:
            ``(1) The term `qualified infectious disease prevention 
        product' means a qualified infectious disease prevention 
        product, as that term is defined in section 3 of the Infectious 
        Diseases Research and Development Act of 2005.
            ``(2) The term `designated product' means a drug, 
        antibiotic drug, or device, as those terms are defined in 
        section 201 of the Federal Food, Drug and Cosmetic Act (21 
        U.S.C. 321), or a biological product, as that term is defined 
        in section 351 of the Public Health Service Act.
            ``(3) The term `diagnostic test' has the meaning given to 
        that term in section 3 of the Infectious Diseases Research and 
        Development Act of 2005.
            ``(4) The term `eligible entity' means a natural or legal 
        person that has successfully developed a qualified infectious 
        disease prevention product.
            ``(5) The term `eligible patent' means a patent that at the 
        time the eligible entity entered into the contract to develop 
        the qualified infectious disease prevention product involved, 
        was owned by or licensed to that eligible entity, and claims a 
        designated product, an active ingredient of a designated 
        product, a method of making or using a designated product or a 
        method of making or using an active ingredient of a designated 
        product.
    ``(b) Patent Term Extension.--The term of an eligible patent shall 
be extended for a period of 2 years, in addition to the term which 
would otherwise apply except for this section, if--
            ``(1) an application under subsection (c) is submitted to 
        the Director by either the owner of record of the patent or its 
        agent on or before the date specified in subsection (c)(3);
            ``(2) the patent has not been previously extended under 
        this section, or under section 156 or 156a;
            ``(3) the patent has not expired before the date that the 
        application is submitted;
            ``(4) the term of no other patent has been extended based 
        on the certification being relied upon by the eligible entity 
        to request extension of the patent; and
            ``(5) no other patent that claims the designated product, 
        an active ingredient of the designated product, a method of 
        making or using a designated product or a method of making or 
        using an active ingredient of a designated product has been 
        extended under this section or under section 156a.
    ``(c) Administrative Provisions.--
            ``(1) In general.--To obtain an extension of the term of a 
        patent under this section, the owner of record of the patent or 
        the agent of the owner shall submit an application to the 
        Director.
            ``(2) Content.--An application filed under this section 
        shall contain--
                    ``(A) a description of the approved qualified 
                infectious disease prevention product and the Federal 
                statute under which regulatory review occurred;
                    ``(B) the identity of the eligible patent for which 
                an extension is sought under this section;
                    ``(C) the identity of the eligible entity and the 
                applicant (if different from the eligible entity);
                    ``(D) the identity of the designated product to 
                which the eligible patent relates;
                    ``(E) information concerning the certification 
                specified in section 5(c)(1) of the Infectious Diseases 
                Research and Development Act of 2005 being relied upon 
                as the basis of the extension being requested;
                    ``(F) information indicating that the entity owned 
                or licensed the eligible patent at the time it entered 
                into the contract to develop the qualified infectious 
                disease prevention product; and
                    ``(G) such other information as the Director may 
                require including to establish that the applicant meets 
                the requirements of this section.
            ``(3) Submission of application.--An application under this 
        section shall be submitted to the Director within 60 days after 
        the date of the certification specified in section 5(c)(1) of 
        the Infectious Diseases Research and Development Act of 2005 
        that is being relied upon to request extension of the patent 
        that is the subject of the application.
    ``(d) Irrevocable Election.--The submission of an application under 
this section is an irrevocable election of the application of this 
section to the patent that is the basis of the application. A patent 
that has been the basis of an application made under this section may 
not be the subject of an application made under sections 156 or 
156a.''.
            (3) Technical and conforming amendment.--The table of 
        sections for chapter 14 of title 35, United States Code, is 
        amended by adding at the end the following:

``158. Extension of patent terms relating to countermeasure 
                            products.''.

SEC. 6. ACCELERATED APPROVAL OF QUALIFIED INFECTIOUS DISEASE PRODUCTS.

    (a) Designation as Fast-Track Product.--
            (1) In general.--The Secretary of Health and Human Services 
        shall designate qualified infectious disease products as fast-
        track products, pursuant to section 506 or section 515(d)(5), 
        as applicable, of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 356, 360e(5)). Such designation may be made prior to the 
        submission of--
                    (A) a request for designation by the sponsor or 
                applicant; or
                    (B) an application for the investigation of the 
                qualified infectious disease product under section 505 
                or 520(g) of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 355) or section 351 of the Public Health 
                Service Act (42 U.S.C. 262).
            (2) Rule of construction.--Nothing in this section shall be 
        construed to prohibit a sponsor or applicant from declining a 
        designation under paragraph (1).
    (b) Grants for Clinical Tests.--Subpart 6 of part C of title IV of 
the Public Health Service Act (42 U.S.C. 285f et seq.) is amended by 
adding at the end the following:

``SEC. 447C. CLINICAL TRIALS ON QUALIFIED INFECTIOUS DISEASE PRODUCTS.

    ``(a) Grants.--In carrying out section 446, the Director of the 
Institute shall expand and intensify efforts to assist small 
manufacturers to conduct end-stage clinical trials on qualified 
infectious disease products, including by awarding grants for such 
clinical trials.
    ``(b) Definition.--In this section, the term `qualified infectious 
disease product' has the meaning given to that term in section 3 of the 
Infectious Diseases Research and Development Act of 2005.''.

SEC. 7. TAX CREDIT FOR MEDICAL RESEARCH RELATED TO DEVELOPING QUALIFIED 
              INFECTIOUS DISEASE PRODUCTS.

    (a) In General.--Subpart D of part IV of subchapter A of chapter 1 
of the Internal Revenue Code of 1986 (relating to business-related 
credits) is amended by adding at the end the following new section:

``SEC. 45J. CREDIT FOR MEDICAL RESEARCH RELATED TO DEVELOPING QUALIFIED 
              INFECTIOUS DISEASE PRODUCTS.

    ``(a) General Rule.--For purposes of section 38, the infectious 
disease research credit determined under this section for the taxable 
year is an amount equal to 35 percent of the qualified infectious 
disease research expenses for the taxable year.
    ``(b) Qualified Infectious Disease Research Expenses.--For purposes 
of this section--
            ``(1) Qualified infectious disease research expenses.--
        Except as otherwise provided in this subsection, the term 
        `qualified infectious disease research expenses' means the 
        amounts which are paid or incurred by the taxpayer during the 
        taxable year with respect to any research and development of 
        qualified infectious disease products which would be described 
        in subsection (b) of section 41 if such subsection were applied 
        with the modifications set forth in paragraph (2).
            ``(2) Modifications; increased incentive for contract 
        research payments.--For purposes of paragraph (1), subsection 
        (b) of section 41 shall be applied--
                    ``(A) by substituting `qualified infectious disease 
                research' for `qualified research' each place it 
                appears in paragraphs (2) and (3) of such subsection, 
                and
                    ``(B) by substituting `100 percent' for `65 
                percent' in paragraph (3)(A) of such subsection.
            ``(3) Exclusion for amounts funded by grants, etc.--The 
        term `qualified infectious disease research expenses' shall not 
        include any amount to the extent such amount is funded by any 
        grant, contract, or otherwise by another person (or any 
        governmental entity).
            ``(4) Qualified infectious disease research.--The term 
        `qualified infectious disease research' means qualified 
        research (as defined in section 41(d)) which relates to the 
        development of a qualified infectious disease product, except 
        that qualified infectious disease research shall include 
        expenses related to re-formulating existing qualified 
        infectious disease products.
            ``(5) Qualified infectious disease products.--The term 
        `qualified infectious disease products' has the meaning given 
        such term in section 3 of the Infectious Diseases Research and 
        Development Act of 2005.
    ``(c) Coordination With Credit for Increasing Research 
Expenditures.--
            ``(1) In general.--Except as provided in paragraph (2), any 
        qualified infectious disease research expenses for a taxable 
        year to which an election under this section applies shall not 
        be taken into account for purposes of determining the credit 
        allowable under section 41 for such taxable year.
            ``(2) Expenses included in determining base period research 
        expenses.--Any qualified infectious disease research expenses 
        for any taxable year which are qualified research expenses 
        (within the meaning of section 41(b)) shall be taken into 
        account in determining base period research expenses for 
        purposes of applying section 41 to subsequent taxable years.
    ``(d) Special Rules.--
            ``(1) Certain rules made applicable.--Rules similar to the 
        rules of paragraphs (1) and (2) of section 41(f) shall apply 
        for purposes of this section.
            ``(2) Coordination with credit for clinical testing 
        expenses for certain drugs for rare diseases.--Any qualified 
        infectious disease research expenses for a taxable year to 
        which an election under this section applies shall not be taken 
        into account for purposes of determining the credit allowable 
        under section 45C for such taxable year.
            ``(3) Election.--This section shall apply to any taxpayer 
        for any taxable year only if such taxpayer elects (at such time 
        and in such manner as the Secretary may by regulations 
        prescribe) to have this section apply for such taxable year.''.
    (b) Inclusion in General Business Credit.--Section 38(b) of the 
Internal Revenue Code of 1986 is amended by striking ``plus'' at the 
end of paragraph (18), by striking the period at the end of paragraph 
(19) and inserting ``, plus'', and by adding at the end the following 
new paragraph:
            ``(20) the infectious disease research credit determined 
        under section 45J.''.
    (c) Denial of Double Benefit.--Section 280C of the Internal Revenue 
Code of 1986 (relating to certain expenses for which credits are 
allowable) is amended by adding at the end the following new 
subsection:
    ``(e) Credit for Qualified Infectious Disease Research Expenses.--
            ``(1) In general.--No deduction shall be allowed for that 
        portion of the qualified infectious disease research expenses 
        (as defined in section 45J(b)) otherwise allowable as a 
        deduction for the taxable year which is equal to the amount of 
        the credit determined for such taxable year under section 
        45J(a).
            ``(2) Certain rules to apply.--Rules similar to the rules 
        of paragraphs (2), (3), and (4) of subsection (c) shall apply 
        for purposes of this subsection.''.
    (d) Deduction for Unused Portion of Credit.--Section 196(c) of the 
Internal Revenue Code of 1986 (defining qualified business credits) is 
amended by striking ``and'' at the end of paragraph (11), by striking 
the period at the end of paragraph (12) and inserting ``, and'', and by 
adding at the end the following new paragraph:
            ``(13) the infectious disease research credit determined 
        under section 45J(a) (other than such credit determined under 
        the rules of section 280C(e)(2)).''.
    (e) Technical Amendment.--The table of sections for subpart D of 
part IV of subchapter A of chapter 1 of the Internal Revenue Code of 
1986 is amended by adding at the end the following new item:

``Sec. 45J. Credit for medical research related to developing qualified 
                            infectious disease products.''.
    (f) Effective Date.--The amendments made by this section shall 
apply to taxable years beginning after December 31, 2004.

SEC. 8. INCENTIVES FOR THE CONSTRUCTION OF QUALIFIED INFECTIOUS DISEASE 
              PRODUCTS MANUFACTURING FACILITIES.

    (a) Qualified Infectious Disease Products Manufacturing Facilities 
Investment Tax Credit.--
            (1) Allowance of credit.--Section 46 of the Internal 
        Revenue Code of 1986 (relating to amount of investment credit) 
        is amended by striking ``and'' at the end of paragraph (1), by 
        striking the period at the end of paragraph (2) and inserting 
        ``, and'', and by adding at the end the following new 
        paragraph:
            ``(3) the qualified infectious disease products 
        manufacturing facilities investment credit.''.
            (2) Amount of credit.--Subpart E of part IV of subchapter A 
        of chapter 1 of such Code (relating to rules for computing 
        investment credit) is amended by inserting after section 48 the 
        following new section:

``SEC. 48A. QUALIFIED INFECTIOUS DISEASE PRODUCTS MANUFACTURING 
              FACILITIES CREDIT.

    ``(a) In General.--For purposes of section 46, the qualified 
infectious disease products manufacturing facilities investment credit 
for any taxable year is an amount equal to 20 percent of the qualified 
investment for such taxable year.
    ``(b) Qualified Investment.--
            ``(1) In general.--For purposes of subsection (a), the 
        qualified investment for any taxable year is the basis of each 
        qualified infectious disease products manufacturing facilities 
        property placed in service by the taxpayer during such taxable 
        year.
            ``(2) Qualified infectious disease products manufacturing 
        facilities property.--For purposes of this section, the term 
        `qualified infectious disease products manufacturing facilities 
        property' means real and tangible personal property--
                    ``(A)(i) the original use of which commences with 
                the taxpayer, or
                    ``(ii) which is acquired through purchase (as 
                defined by section 179(d)(2)),
                    ``(B) which is depreciable under section 167,
                    ``(C) which is used for the manufacture, 
                distribution, or research and development of qualified 
                infectious disease products, and
                    ``(D) which is in compliance with any standards and 
                regulations which are promulgated by the Food and Drug 
                Administration, the Occupational Safety and Health 
                Administration, or the Environmental Protection Agency 
                and which are applicable to such property.
            ``(3) Qualified infectious disease products.--For purposes 
        of this subsection, the term `qualified infectious disease 
        products' has the meaning given such term in section 3 of the 
        Infectious Diseases Research and Development Act of 2005.
    ``(c) Certain Progress Expenditure Rules Made Applicable.--Rules 
similar to rules of subsections (c)(4) and (d) of section 46 (as in 
effect on the day before the date of the enactment of the Revenue 
Reconciliation Act of 1990) shall apply for purposes of this 
subsection.
    ``(d) Termination.--This subsection shall not apply to any property 
placed in service after December 31, 2009.''.
    (b) Technical Amendments.--
            (1) Clause (iii) of section 49(a)(1)(C) of such Code is 
        amended to read as follows:
                            ``(iii) the basis of any qualified 
                        infectious disease products manufacturing 
                        facilities property.''.
            (2) Subparagraph (E) of section 50(a)(2) of such Code is 
        amended by inserting ``or 48A(c)'' before the period.
            (3) The table of sections for subpart E of part IV of 
        subchapter A of chapter 1 of such Code is amended by inserting 
        after the item relating to section 48 the following:

``Sec. 48A. Qualified infectious disease products manufacturing 
                            facilities credit.''.
    (c) Effective Date.--The amendments made by this section shall 
apply to property placed in service after December 31, 2004, under 
rules similar to the rules of section 48(m) of the Internal Revenue 
Code of 1986 (as in effect on the day before the date of enactment of 
the Revenue Reconciliation Act of 1990).

SEC. 9. COMBATING ANTIMICROBIAL RESISTANCE.

    Subsection (g) of section 319E of the Public Health Service Act (42 
U.S.C. 247d-5) is amended to read as follows:
    ``(g) Authorization of Appropriations.--
            ``(1) Authorization.--There are authorized to be 
        appropriated to carry out this section $40,000,000 for fiscal 
        year 2001 and such sums as may be necessary for each of fiscal 
        years 2002 through 2006.
            ``(2) Allocation.--
                    ``(A) In general.--Of the amount appropriated to 
                carry out this section for a fiscal year, the Secretary 
                shall make available not less than $25,000,000 for 
                activities of the Centers for Disease Control and 
                Prevention under subsections (b), (c), (d), and (e).
                    ``(B) Ratable reduction.--If amounts appropriated 
                to carry out this section for a fiscal year are less 
                than $25,000,000, the Secretary shall ratably reduce 
                the amount to be made available under subparagraph 
                (A).''.

SEC. 10. COMMISSION ON INFECTIOUS DISEASES PRODUCT DEVELOPMENT.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 319E the following:

``SEC. 319E-1. COMMISSION ON INFECTIOUS DISEASES PRODUCT DEVELOPMENT.

    ``(a) Establishment.--There is established a permanent commission 
to be known as the `Commission on Infectious Diseases Product 
Development'.
    ``(b) Duties.--
            ``(1) Identification of pathogens.--The Commission shall--
                    ``(A) not later than the end of calendar year 2006, 
                identify the infectious pathogens that are (or are 
                likely to become) a significant threat to public health 
                because of drug resistance or other factors;
                    ``(B) taking into consideration the risks and 
                benefits to public health, make recommendations to the 
                Secretary on how best to address such pathogens, 
                including through the development of qualified 
                infectious disease products to prevent, detect, and 
                treat such pathogens; and
                    ``(C) periodically review and update the list of 
                pathogens identified under subparagraph (A).
            ``(2) Recommendations.--Not later than 90 days after the 
        date of the enactment of this section, the Commission shall 
        submit a report to the Secretary containing recommendations on 
        the actions the Secretary should take to ensure that a 
        sufficient quantity of vaccines and anti-virals are available 
        to treat the American population in the event of a pandemic 
        influenza outbreak.
    ``(c) Antimicrobial Resistance Task Force.--In carrying out this 
section, the Commission shall consult with the Antimicrobial Resistance 
Task Force established under section 319-E.
    ``(d) Membership.--
            ``(1) In general.--The Commission shall be composed of--
                    ``(A) not more than 19 voting members appointed by 
                the President under paragraph (2); and
                    ``(B) the nonvoting ex officio members listed in 
                paragraph (3).
            ``(2) Voting members.--The President shall appoint not more 
        than 19 voting members of the Commission as follows:
                    ``(A) 12 of the voting members shall be appointed 
                from among the leading representatives (including 
                individuals in industry) of the infectious disease 
                medical, research, pharmaceutical, and biological 
                communities.
                    ``(B) 7 of the voting members--
                            ``(i) shall be appointed from among the 
                        general public; and
                            ``(ii) shall include leaders in the fields 
                        of public policy, law, health policy, 
                        economics, and management.
            ``(3) Nonvoting ex officio members.--The Commission shall 
        include the following nonvoting ex officio members:
                    ``(A) The Secretary of Homeland Security (or the 
                Secretary's designee).
                    ``(B) The Secretary of Health and Human Services 
                (or the Secretary's designee).
                    ``(C) The Director of the National Institutes of 
                Health (or the Director's designee).
                    ``(D) The Commissioner of Food and Drugs (or the 
                Commissioner's designee).
                    ``(E) The Director of the Centers for Disease 
                Control and Prevention (or the Director's designee).
                    ``(F) The Assistant Secretary of Defense for Health 
                Affairs (or the Assistant Secretary's designee).
                    ``(G) The Under Secretary for Health of the 
                Department of Veterans Affairs (or the Under 
                Secretary's designee).
                    ``(H) The Secretary of Agriculture (or the 
                Secretary's designee).
                    ``(I) Such additional ex officio members as the 
                Secretary determines necessary for the Commission to 
                carry out its functions.
            ``(4) Terms.--Each member appointed under paragraph (2) 
        shall be appointed for a term of 6 years.
            ``(5) Vacancies.--Any member appointed to fill a vacancy 
        occurring before the expiration of the term for which the 
        member's predecessor was appointed shall be appointed only for 
        the remainder of that term. A member may serve after the 
        expiration of that member's term until a successor has taken 
        office. A vacancy in the Commission shall be filled in the 
        manner in which the original appointment was made.
            ``(6) Basic pay.--
                    ``(A) Rates of pay.--Members of the Commission who 
                are officers or employees of the United States shall 
                not receive any compensation for service on the 
                Commission. The other members of the Commission shall 
                receive, for each day (including traveltime) they are 
                engaged in the performance of the functions of the 
                Commission, compensation at rates not to exceed the 
                daily equivalent of the annual rate in effect for grade 
                GS-15 of the General Schedule.
                    ``(B) Travel expenses.--Each member of the 
                Commission shall receive travel expenses, including per 
                diem in lieu of subsistence, in accordance with 
                applicable provisions under subchapter I of chapter 57 
                of title 5, United States Code.
            ``(7) Chairperson.--The Chairperson of the Commission shall 
        be a representative of the infectious disease medical or 
        research community selected by the President from among the 
        members appointed under subsection (d)(2). The term of office 
        of the Chairperson shall be 2 years.
            ``(8) Meetings.--The Commission shall meet at the call of 
        the Chairperson of the Commission or the Secretary, but not 
        less than 4 times each year.
    ``(e) Director and Staff of Commission; Experts and Consultants.--
            ``(1) Director.--The Commission shall have a Director who 
        shall be appointed by the Commission.
            ``(2) Staff.--The Director of the Commission may appoint 
        such additional personnel as the Director considers 
        appropriate.
            ``(3) Applicability of certain civil services laws.--The 
        Director and staff of the Commission shall be appointed without 
        regard to the provisions of title 5, United States Code, 
        governing appointments in the competitive service, and shall be 
        paid without regard to the provisions of chapter 51 and 
        subchapter III of chapter 53 of that title relating to 
        classification of positions and General Schedule pay rates, 
        except that the rate of pay for the Director and staff of the 
        Commission may not exceed the daily equivalent of the annual 
        rate in effect for grade GS-15 of the General Schedule.
            ``(4) Experts and consultants.--The Commission may procure 
        temporary and intermittent services under section 3109(b) of 
        title 5, United States Code.
            ``(5) Staff of federal agencies.--Upon the request of the 
        Commission, the head of any Federal agency may detail, without 
        reimbursement, any of the personnel of such agency to the 
        Commission to assist in carrying out the duties of the 
        Commission. Any such detail shall not interrupt or otherwise 
        affect the civil service status or privileges of the Federal 
        employee.
    ``(f) Powers of Commission.--
            ``(1) Hearings and sessions.--The Commission may, for the 
        purpose of carrying out this Act, hold hearings, sit and act at 
        times and places, take testimony, and receive evidence as the 
        Commission considers appropriate.
            ``(2) Powers of members and agents.--Any member or agent of 
        the Commission may, if authorized by the Commission, take any 
        action which the Commission is authorized to take by this 
        section.
            ``(3) Mails.--The Commission may use the United States 
        mails in the same manner and under the same conditions as other 
        departments and agencies of the United States.
            ``(4) Administrative support services.--Upon the request of 
        the Commission, the Administrator of General Services shall 
        provide to the Commission, on a reimbursable basis, the 
        administrative support services necessary for the Commission to 
        carry out its responsibilities under this section.
    ``(g) Annual Reports.--Not later than the end of calendar year 2006 
and annually thereafter, the Commission shall prepare and submit to the 
President, the appropriate committees of the Congress, and the 
Secretary of Health and Human Services a report that contains a 
detailed statement of the recommendations, findings, and conclusions of 
the Commission. Each such report shall include an updated list of the 
infectious pathogens identified by the Commission pursuant to 
subsection (b)(1)(A).
    ``(h) Definitions.--In this section:
            ``(1) The term `Commission' means the Commission on 
        Infectious Diseases Product Development established under this 
        section.
            ``(2) The term `qualified infectious disease product' has 
        the meaning given to that term in section 3 of the Infectious 
        Diseases Research and Development Act of 2005.
    ``(i) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $3,000,000 for fiscal year 2006 
and such sums as may be necessary for each subsequent fiscal year.''.

SEC. 11. CLINICAL TRIAL GUIDELINES FOR ANTIBIOTIC DRUGS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 510 the following:

``SEC. 511. CLINICAL TRIAL GUIDELINES FOR ANTIBIOTIC DRUGS.

    ``(a) In General.--Not later than 1 year after the date of 
enactment of the Infectious Diseases Research and Development Act of 
2005, the Secretary, acting through the Commissioner of Food and Drugs, 
shall issue guidelines for the conduct of clinical trials with respect 
to antibiotic drugs, including antimicrobials to treat resistant 
pathogens, bacterial meningitis, acute bacterial sinusitis, acute 
bacterial otitis media, and acute exacerbation of chronic bronchitis. 
Such guidelines shall indicate the appropriate animal models of 
infection, in vitro techniques, and valid microbiologic surrogate 
markers.
    ``(b) Review.--Not later than 5 years after the date of enactment 
of the Infectious Diseases Research and Development Act of 2005, the 
Secretary, acting through the Commissioner of Food and Drugs, shall 
review and update the guidelines described under subsection (a) to 
reflect developments in scientific and medical information and 
technology.''.
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