[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2405 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 2405

To reauthorize certain provisions of the Public Health Service Act and 
  the Federal Food, Drug, and Cosmetic Act relating to public health 
  preparedness and countermeasure development, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 28, 2011

Mr. Rogers of Michigan (for himself, Mrs. Myrick, and Mr. Gene Green of 
    Texas) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To reauthorize certain provisions of the Public Health Service Act and 
  the Federal Food, Drug, and Cosmetic Act relating to public health 
  preparedness and countermeasure development, 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; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness Reauthorization Act of 2011''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Reauthorization of certain provisions relating to public health 
                            preparedness.
Sec. 3. Coordination by Assistant Secretary for Preparedness and 
                            Response.
Sec. 4. Eliminating duplicative Project Bioshield reports.
Sec. 5. Accelerate countermeasure development by strengthening FDA's 
                            role in reviewing products for national 
                            security priorities.

SEC. 2. REAUTHORIZATION OF CERTAIN PROVISIONS RELATING TO PUBLIC HEALTH 
              PREPAREDNESS.

    (a) Vaccine Tracking and Distribution.--Subsection (e) of section 
319A of the Public Health Service Act (42 U.S.C. 247d-1) is amended by 
striking ``such sums for each of fiscal years 2007 through 2011'' and 
inserting ``$30,800,000 for each of fiscal years 2012 through 2016''.
    (b) Improving State and Local Public Health Security.--Effective on 
October 1, 2011, section 319C-1 of the Public Health Service Act (42 
U.S.C. 247d-3a) is amended--
            (1) in subsection (f)--
                    (A) in paragraph (2), by inserting ``and'' at the 
                end;
                    (B) in paragraph (3), by striking ``; and'' and 
                inserting a period; and
                    (C) by striking paragraph (4);
            (2) by striking subsection (h); and
            (3) in subsection (i)--
                    (A) in paragraph (1)--
                            (i) by amending subparagraph (A) to read as 
                        follows:
                    ``(A) In general.--For the purpose of carrying out 
                this section, there is authorized to be appropriated 
                $632,900,000 for each of fiscal years 2012 through 
                2016.''; and
                            (ii) by striking subparagraph (B); and
                    (B) in subparagraphs (C) and (D) of paragraph (3), 
                by striking ``(1)(A)(i)(I)'' each place it appears and 
                inserting ``(1)(A)''.
    (c) Partnerships for State and Regional Hospital Preparedness To 
Improve Surge Capacity.--Paragraph (1) of section 319C-2(j) of the 
Public Health Service Act (42 U.S.C. 247d-3b(j)) is amended to read as 
follows:
            ``(1) In general.--For purposes of carrying out this 
        section, there is authorized to be appropriated $378,000,000 
        for each of fiscal years 2012 through 2016.''.
    (d) CDC Programs for Combating Public Health Threats.--Section 319D 
of the Public Health Service Act (42 U.S.C. 247d-4) is amended--
            (1) by striking subsection (c); and
            (2) in subsection (g), by striking ``such sums as may be 
        necessary in each of fiscal years 2007 through 2011'' and 
        inserting ``$160,121,000 for each of fiscal years 2012 through 
        2016''.
    (e) Dental Emergency Responders: Public Health and Medical 
Response.--
            (1) All-hazards public health and medical response 
        curricula and training.--Section 319F(a)(5)(B) of the Public 
        Health Service Act (42 U.S.C. 247d-6(a)(5)(B)) is amended by 
        striking ``public health or medical'' and inserting ``public 
        health, medical, or dental''.
            (2) National health security strategy.--Section 2802(b)(3) 
        of the Public Health Service Act (42 U.S.C. 300hh-1(b)(3)) is 
        amended--
                    (A) in the matter preceding subparagraph (A), by 
                inserting ``and which may include dental health 
                facilities'' after ``mental health facilities''; and
                    (B) in subparagraph (D), by inserting ``(which may 
                include such dental health assets)'' after ``medical 
                assets''.
    (f) Procurement of Countermeasures.--
            (1) Contract terms.--Clause (ii) of section 319F-2(c)(7)(C) 
        of the Public Health Service Act (42 U.S.C. 247d-6b(c)(7)(C)) 
        is amended by adding at the end the following:
                                    ``(X) Government purpose.--The 
                                contract shall provide a clear 
                                statement of defined Government purpose 
                                limited to uses related to a security 
                                countermeasure, as defined in paragraph 
                                (1)(B).''.
            (2) Reauthorization of the special reserve fund.--Section 
        319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) is 
        amended--
                    (A) in subsection (c)--
                            (i) by striking ``special reserve fund 
                        under paragraph (10)'' each place it appears 
                        and inserting ``special reserve fund as defined 
                        in subsection (g)(5)''; and
                            (ii) by striking paragraphs (9) and (10); 
                        and
                    (B) by adding at the end the following:
    ``(g) Special Reserve Fund.--
            ``(1) Authorization of appropriations.--In addition to 
        amounts appropriated to the special reserve fund prior to the 
        date of the enactment of this subsection, there is authorized 
        to be appropriated, for the procurement of security 
        countermeasures under subsection (c) and for carrying out 
        section 319L (relating to the Biomedical Advanced Research and 
        Development Authority), $2,800,000,000 for the period of fiscal 
        years 2014 through 2018. Amounts appropriated pursuant to the 
        preceding sentence are authorized to remain available until 
        September 30, 2019.
            ``(2) Notice of insufficient funds.--Not later than 15 days 
        after any date on which the Secretary determines that the 
        amount of funds in the special reserve fund available for 
        procurement is less than $1,500,000,000, the Secretary shall 
        submit to the relevant committees of Congress a report 
        detailing the amount of such funds available for procurement 
        and the impact such funding will have--
                    ``(A) in meeting the security countermeasure needs 
                identified under this section; and
                    ``(B) on the annual Public Health Emergency Medical 
                Countermeasure Enterprise Implementation Plan under 
                section 319F-5(b).
            ``(3) Use of special reserve fund for advanced research and 
        development.--The Secretary, acting through the Director of the 
        Biomedical Advanced Research and Development Authority, may 
        utilize not more than 30 percent of the amounts authorized to 
        be appropriated under paragraph (1) to carry out section 319L 
        (related to the Biomedical Advanced Research and Development 
        Authority). Amounts authorized to be appropriated under this 
        subsection to carry out section 319L are in addition to amounts 
        otherwise authorized to be appropriated to carry out such 
        section.
            ``(4) Restrictions on use of funds.--Amounts in the special 
        reserve fund shall not be used to pay--
                    ``(A) costs other than payments made by the 
                Secretary to a vendor for advanced research and 
                development or procurement of a security countermeasure 
                under subsection (c)(7); and
                    ``(B) any administrative expenses, including 
                salaries.
            ``(5) Definition.--In this section, the term `special 
        reserve fund' means the `Biodefense Countermeasures' 
        appropriations account, any appropriation made available 
        pursuant to section 521(a) of the Homeland Security Act of 
        2002, and any appropriation made available pursuant to 
        paragraph (1) of this paragraph.''.
    (g) Biomedical Advanced Research and Development Authority.--
            (1) Transaction authorities.--Section 319L(c)(5) of the 
        Public Health Service Act (42 U.S.C. 247d-7e(c)(5)) is amended 
        by adding at the end the following:
                    ``(G) Government purpose.--In awarding contracts, 
                grants, and cooperative agreements under this section, 
                the Secretary shall provide a clear statement of 
                defined Government purpose related to activities 
                included in subsection (a)(6)(B) for a qualified 
                countermeasure or qualified pandemic or epidemic 
                product.''.
            (2) Biodefense medical countermeasure development fund.--
        Paragraph (2) of section 319L(d) of the Public Health Service 
        Act (42 U.S.C. 247d-7e(d)) is amended to read as follows:
            ``(2) Funding.--To carry out the purposes of this section, 
        there is authorized to be appropriated to the Fund $415,000,000 
        for each of fiscal years 2012 through 2016, the amounts to 
        remain available until expended.''.
            (3) Continued inapplicability of certain provisions.--
        Section 319L(e)(1)(C) of the Public Health Service Act (42 
        U.S.C. 247d-7e(e)(1)(C)) is amended by striking ``7 years'' and 
        inserting ``10 years''.
    (h) National Disaster Medical System.--Section 2812 of the Public 
Health Service Act (42 U.S.C. 300hh-11) is amended--
            (1) in subsection (a)(3), by adding at the end the 
        following:
                    ``(D) Administration.--The Secretary may determine 
                and pay claims for reimbursement for services under 
                subparagraph (A) directly or by contract providing for 
                payment in advance or by way of reimbursement.''; and
            (2) in subsection (g), by striking ``such sums as may be 
        necessary for each of the fiscal years 2007 through 2011'' and 
        inserting ``$56,000,000 for each of fiscal years 2012 through 
        2016''.
    (i) Extension of Limited Antitrust Exemption.--Section 405(b) of 
the Pandemic and All-Hazard Preparedness Act (42 U.S.C. 247d-6a note) 
is amended by striking ``6-year'' and inserting ``10-year''.

SEC. 3. COORDINATION BY ASSISTANT SECRETARY FOR PREPAREDNESS AND 
              RESPONSE.

    (a) In General.--Section 2811 of the Public Health Service Act (42 
U.S.C. 300hh-10) is amended--
            (1) in subsection (b)(3)--
                    (A) by inserting ``stockpiling, distribution,'' 
                before ``and procurement''; and
                    (B) by inserting ``, security measures (as defined 
                in section 319F-2,'' after ``qualified countermeasures 
                (as defined in section 319F-1)'';
            (2) in subsection (b)(4), by adding at the end the 
        following:
                    ``(D) Identification of inefficiencies.--Identify 
                gaps, duplication, and other inefficiencies in public 
                health preparedness activities and the actions 
                necessary to overcome these obstacles.
                    ``(E) Development of countermeasure implementation 
                plan.--Lead the development of a coordinated 
                Countermeasure Implementation Plan under subsection 
                (d).
                    ``(F) Countermeasures budget analysis.--Oversee, in 
                consultation with the Director of the Office of 
                Management and Budget, the development of a 
                comprehensive, cross-cutting 5-year budget analysis 
                with respect to activities described in paragraph (3)--
                            ``(i) to inform prioritization of 
                        resources; and
                            ``(ii) to ensure that challenges are 
                        adequately addressed.
                    ``(G) Grant programs for medical and public health 
                preparedness capabilities.--Coordinate, in consultation 
                with the Secretary of Homeland Security, grant programs 
                of the Department of Health and Human Services relating 
                to medical and public health preparedness capabilities 
                and the ability of local communities to respond to 
                public health emergencies, including by--
                            ``(i) coordinating the program 
                        requirements, timelines, and measurable goals 
                        of such grant programs; and
                            ``(ii) establishing a system for gathering 
                        and disseminating best practices among grant 
                        recipients.'';
            (3) by amending subsection (c) to read as follows:
    ``(c) Functions.--The Assistant Secretary for Preparedness and 
Response shall--
            ``(1) have authority over and responsibility for--
                    ``(A) the National Disaster Medical System (in 
                accordance with section 301 of the Pandemic and All-
                Hazards Preparedness Act);
                    ``(B) the Hospital Preparedness Cooperative 
                Agreement Program pursuant to section 319C-2;
                    ``(C) the Biomedical Advanced Research and 
                Development Authority under section 319L;
                    ``(D) the Medical Reserve Corps pursuant to section 
                2813;
                    ``(E) the Emergency System for Advance Registration 
                of Volunteer Health Professionals pursuant to section 
                319I;
                    ``(F) the Strategic National Stockpile; and
                    ``(G) the Cities Readiness Initiative; and
            ``(2) assume other duties as determined appropriate by the 
        Secretary.''; and
            (4) by adding at the end the following:
    ``(d) Countermeasure Implementation Plan.--Not later than 6 months 
after the date of enactment of this subsection, and annually 
thereafter, the Assistant Secretary for Preparedness and Response shall 
submit to the Secretary and relevant congressional committees a 
Countermeasure Implementation Plan that--
            ``(1) describes the chemical, biological, radiological, and 
        nuclear threats facing the Nation and the corresponding efforts 
        to develop qualified countermeasures (as defined in section 
        319F-1), secured countermeasures (as defined in section 319F-
        2), or qualified pandemic or epidemic products (as defined in 
        section 319F-3) for each threat;
            ``(2) evaluates the progress of all activities with respect 
        to such countermeasures or products, including research, 
        advanced research, development, procurement, stockpiling, 
        deployment, and utilization;
            ``(3) identifies and prioritizes near-, mid-, and long-term 
        needs with respect to such countermeasures or products to 
        address chemical, biological, radiological, and nuclear 
        threats;
            ``(4) identifies, with respect to each category of threat, 
        a summary of all advanced development and procurement awards, 
        including the time elapsed from the issuance of the initial 
        solicitation or request for a proposal to the adjudication 
        (such as the award, denial of award, or solicitation 
        termination), and including--
                    ``(A) projected timelines for development and 
                procurement of such countermeasures or products;
                    ``(B) clearly defined goals, benchmarks, and 
                milestones for each countermeasure or product, 
                including information on the number of doses required, 
                the intended use of the countermeasure or product, and 
                the required countermeasure or product characteristics; 
                and
                    ``(C) projected needs with regard to the 
                replenishment of the Strategic National Stockpile;
            ``(5) evaluates progress made in meeting the goals, 
        benchmarks, and milestones identified under paragraph (4);
            ``(6) reports on the amount of funds available for 
        procurement in the special reserve fund as defined in section 
        319F-2(g)(5) and the impact this funding will have on meeting 
        the requirements under section 319F-2; and
            ``(7) incorporates input from Federal, State, local, and 
        tribal stakeholders.''.
    (b) Consultation in Authorizing Medical Products for Use in 
Emergencies.--Subsection (c) of section 564 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb-3) is amended by striking 
``consultation with the Director of the National Institutes of Health'' 
and inserting ``consultation with the Assistant Secretary for 
Preparedness and Response, the Director of the National Institutes of 
Health,''.

SEC. 4. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD REPORTS.

    Section 5 of the Project Bioshield Act of 2004 (42 U.S.C. 247d-6c) 
is repealed.

SEC. 5. ACCELERATE COUNTERMEASURE DEVELOPMENT BY STRENGTHENING FDA'S 
              ROLE IN REVIEWING PRODUCTS FOR NATIONAL SECURITY 
              PRIORITIES.

    (a) In General.--Section 565 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb-4) is amended to read as follows:

``SEC. 565. COUNTERMEASURE DEVELOPMENT AND REVIEW.

    ``(a) Countermeasures and Products.--The countermeasures and 
products referred to in this subsection are--
            ``(1) qualified countermeasures (as defined in section 
        319F-1 of the Public Health Service Act);
            ``(2) security countermeasures (as defined in section 319F-
        2 of such Act); and
            ``(3) qualified pandemic or epidemic products (as defined 
        in section 319F-3 of such Act).
    ``(b) In General.--
            ``(1) Involvement of fda personnel in interagency 
        activities.--The Secretary shall accelerate the development, 
        stockpiling, approval, and licensure of countermeasures and 
        products referred to in subsection (a) by expanding the 
        involvement of Food and Drug Administration personnel in 
        interagency activities with the Biomedical Advanced Research 
        and Development Authority, the Centers for Disease Control and 
        Prevention, the National Institutes of Health, and the 
        Department of Defense.
            ``(2) Technical assistance.--The Secretary shall establish 
        within the Food and Drug Administration a team of experts on 
        manufacturing and regulatory activities (including compliance 
        with current Good Manufacturing Practice) to provide both off-
        site and on-site technical assistance to the manufacturers of 
        countermeasures and products referred to in subsection (a).
    ``(c) Agency Interaction With Security Countermeasure Sponsors.--
            ``(1) Countermeasure development program.--
                    ``(A) In general.--For each security countermeasure 
                (as defined in section 319F-2 of the Public Health 
                Service Act) that is procured under such section 319F-
                2, the Secretary shall initiate, in consultation with 
                the security countermeasure sponsor (referred to in 
                this section as the `countermeasure sponsor'), a 
                program of frequent scientific feedback and 
                interactions regarding the process of developing such 
                countermeasure, including--
                            ``(i) regular meetings between appropriate 
                        Food and Drug Administration personnel and the 
                        countermeasure sponsor during the process of 
                        developing the countermeasure, to be scheduled 
                        within 45 days after attainment of each 
                        milestone identified pursuant to subparagraph 
                        (B)(iv)(I) in the regulatory management plan 
                        for the countermeasure;
                            ``(ii) written feedback from the Food and 
                        Drug Administration within 30 days after 
                        submission of a request for feedback pursuant 
                        to subparagraph (B)(iv)(II) in the regulatory 
                        management plan for the countermeasure;
                            ``(iii) written feedback from the Food and 
                        Drug Administration within 30 days after 
                        submission by the countermeasure sponsor of a 
                        study report that is considered to be complete 
                        pursuant to subparagraph (B)(iv)(III) in the 
                        regulatory management plan for the 
                        countermeasure;
                            ``(iv) at the request of the Director of 
                        the Biomedical Advanced Research and 
                        Development Authority, participation in 
                        meetings of such Authority on the development 
                        of the countermeasure; and
                            ``(v) other meetings, including on-site 
                        meetings, as appropriate.
                    ``(B) Regulatory management plan.--In carrying out 
                the program under subparagraph (A), the Secretary 
                shall, in consultation with the countermeasure sponsor, 
                develop a written regulatory management plan for each 
                security countermeasure (as defined in section 319F-2 
                of the Public Health Service Act) that is procured 
                under such section 319F-2. The regulatory management 
                plan shall be completed within 60 days of issuance of a 
                contract for the countermeasure under such section 
                319F-2 or, for a countermeasure that was procured under 
                such section 319F-2 before the date of the enactment of 
                the Pandemic and All-Hazards Preparedness 
                Reauthorization Act of 2011, within 60 days after such 
                date of enactment. The regulatory management plan for a 
                security countermeasure shall include--
                            ``(i) an assessment of the current 
                        regulatory status, an assessment of known 
                        scientific gaps, and a proposed pathway to 
                        approval or licensure of the countermeasure;
                            ``(ii) guidance by the Food and Drug 
                        Administration regarding the data required to 
                        support delivery of the countermeasure to the 
                        Strategic National Stockpile;
                            ``(iii) guidance by the Food and Drug 
                        Administration regarding data required to 
                        support submission of a proposed agreement on 
                        the design and size of clinical trials for 
                        review under section 505(b)(5)(B); and
                            ``(iv) an agreement between the Food and 
                        Drug Administration and the countermeasure 
                        sponsor to identify--
                                    ``(I) developmental milestones that 
                                will trigger meetings between the 
                                Administration and the sponsor;
                                    ``(II) the process for requesting 
                                and receiving written or oral feedback 
                                from the Administration; and
                                    ``(III) the type study reports that 
                                will be considered by the 
                                Administration to be complete.
                    ``(C) Applicability to certain qualified pandemic 
                or epidemic products.--The Secretary may, with respect 
                to qualified pandemic or epidemic products (as defined 
                in section 319F-3 of the Public Health Service Act) for 
                which a contract for advanced research and development 
                is entered into under section 319L of such Act, choose 
                to apply the provisions of subparagraphs (A) and (B) to 
                the same extent and in the same manner as such 
                provisions apply with respect to security 
                countermeasures.
    ``(d) Final Guidance on Development of Animal Models.--Not later 
than 180 days after the date of the enactment of the Pandemic and All-
Hazards Preparedness Reauthorization Act of 2011, the Secretary shall 
provide final guidance to industry regarding the development of animal 
models to support approval or licensure of countermeasures and products 
referred to in subsection (a) when human efficacy studies are not 
ethical or feasible.
    ``(e) Annual Report.--Not later than January 1, 2012, and every 
January 1 thereafter, the Secretary shall submit a report to the 
Committee on Energy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and Pensions of the Senate 
that, with respect to the preceding fiscal year, includes--
            ``(1) the number of full-time equivalent employees of the 
        Food and Drug Administration who directly support the review of 
        countermeasures and products referred to in subsection (a);
            ``(2) estimates of funds obligated by the Food and Drug 
        Administration for development of such countermeasures and 
        products;
            ``(3) the number of regulatory teams at the Food and Drug 
        Administration specific to such countermeasures and products 
        and, for each such team, the assigned products, classes of 
        products, or technologies;
            ``(4) the length of time between each request by the 
        sponsor of such a countermeasure or product for information and 
        the provision of such information by the Food and Drug 
        Administration;
            ``(5) the number, type, and frequency of official 
        interactions between the Food and Drug Administration and--
                    ``(A) sponsors of a countermeasure or product 
                referred to in subsection (a); or
                    ``(B) another agency engaged in development or 
                management of portfolios for such countermeasures or 
                products, including the Centers for Disease Control and 
                Prevention, the Biomedical Advanced Research and 
                Development Authority, the National Institutes of 
                Health, and the appropriate agencies of the Department 
                of Defense;
            ``(6) any other measure to determine the efficiency of the 
        regulatory teams described in paragraph (3); and
            ``(7) the regulatory science priorities which the Food and 
        Drug Administration is addressing and the progress made on 
        these priorities.''.
    (b) Discussions Between FDA and Sponsor on Design and Size of 
Animal and Clinical Trials Intended To Form the Primary Basis of an 
Effectiveness Claim When Human Efficacy Studies Are Not Ethical or 
Feasible.--Subparagraph (B) of section 505(b)(5) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(b)(5)) is amended to read as 
follows:
    ``(B)(i) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval for a drug under this 
subsection or section 351 of the Public Health Service Act if the 
sponsor or applicant makes a reasonable written request for a meeting 
for the purpose of reaching agreement on the design and size of--
            ``(I) clinical trials intended to form the primary basis of 
        an effectiveness claim; or
            ``(II) animal and clinical trials intended to form the 
        primary basis of an effectiveness claim when human efficacy 
        studies are not ethical or feasible.
    ``(ii) The sponsor or applicant shall provide information necessary 
for discussion and agreement on the design and size of the clinical 
trials. Minutes of any such meeting shall be prepared by the Secretary 
and made available to the sponsor or applicant upon request.''.
                                 <all>