[Congressional Record (Bound Edition), Volume 157 (2011), Part 13]
[House]
[Pages 19004-19011]
[From the U.S. Government Publishing Office, www.gpo.gov]




   PANDEMIC AND ALL-HAZARDS PREPAREDNESS REAUTHORIZATION ACT OF 2011

  Mr. PITTS. Mr. Speaker, I move to suspend the rules and pass the bill 
(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, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 2405

       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. Temporary redeployment of personnel during a public health 
              emergency.
Sec. 4. Coordination by Assistant Secretary for Preparedness and 
              Response.
Sec. 5. Eliminating duplicative Project Bioshield reports.
Sec. 6. Authorization for medical products for use in emergencies.
Sec. 7. Additional provisions related to medical products for emergency 
              use.
Sec. 8. Products held for emergency use.
Sec. 9. 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 (b)(2)(A)--
       (A) in clause (iv), by striking ``and'' at the end;
       (B) in clause (v), by adding ``and'' at the end; and
       (C) by adding at the end the following:
       ``(vi) a description of any activities that such entity 
     will use to analyze real-time clinical specimens for 
     pathogens of public health or bioterrorism significance, 
     including any utilization of poison control centers;'';
       (2) 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);
       (3) by striking subsection (h); and
       (4) 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.--Section 319C-2 of 
     the Public Health Service Act (42 U.S.C. 247d-3b) is 
     amended--
       (1) in subsection (a), by inserting ``, including capacity 
     and preparedness to address the needs of pediatric and other 
     at-risk populations'' before the period at the end;
       (2) in subsection (i)--
       (A) by striking ``The requirements of'' and inserting the 
     following:
       ``(1) In general.--The requirements of''; and
       (B) by adding at the end the following:
       ``(2) Meeting goals of national health security strategy.--
     The Secretary shall implement objective, evidence-based 
     metrics to ensure that entities receiving awards under this 
     section are meeting, to the extent practicable, the goals of 
     the National Health Security Strategy under section 2802.''; 
     and
       (3) by amending subsection (j)(1) 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 
     dental health assets)'' after ``medical assets''.
       (f) Procurement of Countermeasures.--
       (1) Contract terms.--Subclause (IX) of section 319F-
     2(c)(7)(C)(ii) of the Public Health Service Act (42 U.S.C. 
     247d-6b(c)(7)(C)(ii)) is amended to read as follows:

       ``(IX) Contract terms.--The Secretary, in any contract for 
     procurement under this section--

       ``(aa) may specify--
       ``(AA) the dosing and administration requirements for 
     countermeasures to be developed and procured;

[[Page 19005]]

       ``(BB) the amount of funding that will be dedicated by the 
     Secretary for development and acquisition of the 
     countermeasure; and
       ``(CC) the specifications the countermeasure must meet to 
     qualify for procurement under a contract under this section; 
     and
       ``(bb) 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 Committee on Energy and Commerce of the House 
     of Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate 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 Countermeasure Implementation Plan 
     under section 2811(d).
       ``(3) Use of special reserve fund for advanced research and 
     development.--The Secretary 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 development (under section 319L) or for 
     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) Emergency System for Advance Registration of Volunteer 
     Health Professionals.--Section 319I(k) of the Public Health 
     Service Act (42 U.S.C. 247d-7b(k)) is amended by striking 
     ``are authorized to be appropriated $2,000,000 for fiscal 
     year 2002, and such sums as may be necessary for each of the 
     fiscal years 2003 through 2011'' and inserting ``is 
     authorized to be appropriated $5,900,000 for each of fiscal 
     years 2012 through 2016''.
       (h) 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 ``the date 
     that is 7 years after the date of enactment of the Pandemic 
     and All-Hazards Preparedness Act'' and inserting ``September 
     30, 2016''.
       (i) 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''.
       (j) National Health Security Strategy Timeline.--Section 
     2802(a)(1) of the Public Health Service Act (42 U.S.C. 300hh-
     1(a)(1)) is amended by striking ``2009'' and inserting 
     ``2014''.
       (k) Enhancing Surge Capacity.--Section 2802(b) of the 
     Public Health Service Act (42 U.S.C. 300hh-1(b)(3)) is 
     amended--
       (1) in paragraph (1)(A), by inserting ``, including drills 
     and exercises to ensure medical surge capacity for events 
     without notice'' after ``exercises''; and
       (2) in paragraph (3)--
       (A) in the matter preceding subparagraph (A), as amended by 
     subsection (e)(2) of this section--
       (i) by inserting ``availability, coordination, 
     accessibility,'' after ``response capabilities,'';
       (ii) by striking ``including mental health facilities'' and 
     inserting ``including mental health and ambulatory care 
     facilities''; and
       (iii) by striking ``trauma care and emergency medical 
     service systems'' and inserting ``trauma care, critical care, 
     and emergency medical service systems''; and
       (B) in subparagraph (B), by striking ``Medical evacuation 
     and fatality management'' and inserting ``Fatality 
     management, and coordinated medical triage and evacuation to 
     the appropriate medical institution based on patient medical 
     need as part of regional systems''.
       (l) Volunteer Medical Reserve Corps.--Section 2813(i) of 
     the Public Health Service Act (42 U.S.C. 300hh-15(i)) is 
     amended by striking ``$22,000,000 for fiscal year 2007, and 
     such sums as may be necessary for each of fiscal years 2008 
     through 2011'' and inserting ``$11,900,000 for each of fiscal 
     years 2012 through 2016''.
       (m) 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 ``at the end of 
     the 6-year period that begins on the date of enactment of 
     this Act'' and inserting ``on September 30, 2016''.

     SEC. 3. TEMPORARY REDEPLOYMENT OF PERSONNEL DURING A PUBLIC 
                   HEALTH EMERGENCY.

       Section 319 of the Public Health Service Act (42 U.S.C. 
     247d) is amended by adding at the end the following:
       ``(e) Temporary Redeployment of Personnel During a Public 
     Health Emergency.--
       ``(1) Emergency redeployment of federally funded 
     personnel.--Notwithstanding any other provision of law, and 
     subject to paragraph (2), upon a request that is from a 
     State, locality, territory, tribe, or the Freely Associated 
     States and that includes such information and assurances as 
     the Secretary may require, the Secretary may authorize the 
     requesting entity to temporarily redeploy to immediately 
     address a public health emergency non-Federal personnel 
     funded in whole or in part through--
       ``(A) any program under this Act; or
       ``(B) at the discretion of the Secretary, any other program 
     funded in whole or in part by the Department of Health and 
     Human Services.
       ``(2) Activation of emergency redeployment.--
       ``(A) Public health emergency.--The Secretary may exercise 
     the authority vested by paragraph (1) only during the period 
     of a public health emergency determined pursuant to 
     subsection (a).
       ``(B) Considerations.--In authorizing a temporary 
     redeployment under paragraph (1), the Secretary shall 
     consider each of the following:
       ``(i) The degree to which the emergency cannot be 
     adequately and appropriately addressed by the public health 
     workforce.
       ``(ii) The degree to which the emergency requires or would 
     otherwise benefit from supplemental staffing from those 
     funded through nonpreparedness Federal programs.
       ``(iii) The degree to which such programs would be 
     adversely affected by the redeployment.
       ``(iv) Such other factors as the Secretary may deem 
     appropriate.
       ``(C) Termination and extension.--
       ``(i) Termination.--The authority to authorize a temporary 
     redeployment of personnel under paragraph (1) shall terminate 
     upon the earlier of the following:

       ``(I) The Secretary's determination that the public health 
     emergency no longer exists.
       ``(II) Subject to clause (ii), 30 days after the activation 
     of the Secretary's authority pursuant to subparagraph (A).

       ``(ii) Extension authority.--The Secretary may extend the 
     authority to authorize a temporary redeployment of personnel 
     under paragraph (1) beyond the date otherwise applicable 
     under clause (i)(II) if the public health emergency still 
     exists, but only if--

       ``(I) the extension is requested by the entity that 
     requested authority to authorize a temporary redeployment; 
     and
       ``(II) the Secretary gives notice to the Congress in 
     conjunction with the extension.''.

     SEC. 4. 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)'';

[[Page 19006]]

       (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 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 to such activities 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 
     activities of local communities to respond to public health 
     emergencies, including the--
       ``(i) coordination of relevant program requirements, 
     timelines, and measurable goals of such grant programs; and
       ``(ii) establishment of 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 lead responsibility within the Department of 
     Health and Human Services for emergency preparedness and 
     response policy and coordination;
       ``(2) 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; and
       ``(D) the Emergency System for Advance Registration of 
     Volunteer Health Professionals pursuant to section 319I;
       ``(3) provide policy coordination and oversight of--
       ``(A) the Strategic National Stockpile under section 319F-
     2;
       ``(B) the Cities Readiness Initiative; and
       ``(C) the Medical Reserve Corps pursuant to section 2813; 
     and
       ``(4) 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 through the Secretary to the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a 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), security 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--
       ``(A) 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);
       ``(B) projected timelines for development and procurement 
     of such countermeasures or products;
       ``(C) clearly defined goals, benchmarks, and milestones for 
     each such 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
       ``(D) 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)(C);
       ``(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;
       ``(7) incorporates input from Federal, State, local, and 
     tribal stakeholders; and
       ``(8) addresses the needs of pediatric populations with 
     respect to such countermeasures and products in the Strategic 
     National Stockpile and includes--
       ``(A) a list of such countermeasures and products necessary 
     to address the needs of pediatric populations;
       ``(B) a description of measures taken to coordinate with 
     Office of Pediatric Therapeutics of the Food and Drug 
     Administration to maximize the labeling, dosages, and 
     formulations of such countermeasures and products for 
     pediatric populations;
       ``(C) a description of existing gaps in the Strategic 
     National Stockpile and the development of such 
     countermeasures and products to address the needs of 
     pediatric populations; and
       ``(D) an evaluation of the progress made in addressing gaps 
     identified pursuant to subparagraph (C).

     Notwithstanding any other provision of this subsection, the 
     Plan shall not include any confidential commercial 
     information, proprietary information, or information that 
     could reveal vulnerabilities of the Nation in the preparation 
     for or ability to respond to chemical, biological, 
     radiological, or nuclear threats.''.
       (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,''.
       (c) Biosurveillance Plan.--Not later than one year after 
     the date of the enactment of this Act, the Secretary of 
     Health and Human Services shall prepare and submit to the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a plan to improve 
     information sharing, coordination, and communications among 
     disparate biosurveillance systems supported by the Department 
     of Health and Human Services.

     SEC. 5. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD REPORTS.

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

     SEC. 6. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN 
                   EMERGENCIES.

       Section 564 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-3) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1), by striking ``sections 505, 510(k), 
     and 515 of this Act'' and inserting ``any provision of this 
     Act'';
       (B) in paragraph (2)(A), by striking ``under a provision of 
     law referred to in such paragraph'' and inserting ``under a 
     provision of law in section 505, 510(k), or 515 of this Act 
     or section 351 of the Public Health Service Act''; and
       (C) in paragraph (3), by striking ``a provision of law 
     referred to in such paragraph'' and inserting ``a provision 
     of law referred to in paragraph (2)(A)'';
       (2) in subsection (b)--
       (A) in the subsection heading, by striking ``Declaration of 
     Emergency'' and inserting ``Declaration Supporting Emergency 
     Use Authorization'';
       (B) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``an emergency justifying'' and inserting ``that 
     circumstances exist justifying'';
       (ii) in subparagraph (A), by striking ``specified'';
       (iii) in subparagraph (B), by striking ``specified''; and
       (iv) by amending subparagraph (C) to read as follows:
       ``(C) a determination by the Secretary that there is a 
     public health emergency, or a significant potential for a 
     public health emergency, involving a heightened risk to 
     national security or the health and security of United States 
     citizens abroad, and involving a biological, chemical, 
     radiological, or nuclear agent or agents, or a disease or 
     condition that may be attributable to such agent or 
     agents.'';
       (C) in paragraph (2)--
       (i) by amending subparagraph (A) to read as follows:
       ``(A) In general.--A declaration under this subsection 
     shall terminate upon a determination by the Secretary, in 
     consultation with, as appropriate, the Secretary of Homeland 
     Security or the Secretary of Defense, that the circumstances 
     described in paragraph (1) have ceased to exist.'';
       (ii) by striking subparagraph (B); and
       (iii) by redesignating subparagraph (C) as subparagraph 
     (B); and
       (D) in paragraph (4), by striking ``advance notice of 
     termination, and renewal'' and inserting ``and advance notice 
     of termination'';
       (3) in subsection (c)(1), by striking ``specified in'' and 
     insert ``covered by'';
       (4) in subsection (d)(3), by inserting ``, to the extent 
     practicable given the circumstances of the emergency,'' after 
     ``including'';
       (5) in subsection (e)--
       (A) in paragraph (1)(B), by amending clause (iii) to read 
     as follows:
       ``(iii) Appropriate conditions with respect to the 
     collection and analysis of information concerning the safety 
     and effectiveness of the product with respect to the actual 
     use of such product pursuant to an authorization under this 
     section.'';
       (B) in paragraph (2)--
       (i) in subparagraph (A)--

       (I) by striking ``manufacturer of the product'' and 
     inserting ``person''; and
       (II) by inserting ``or in paragraph (1)(B)'' before the 
     period at the end;

       (ii) in subparagraph (B)(i), by inserting ``, with the 
     exception of extensions of a product's expiration date 
     authorized under section 564A(b)'' before the period at the 
     end; and
       (iii) by amending subparagraph (C) to read as follows:
       ``(C) In establishing conditions under this paragraph with 
     respect to the distribution and

[[Page 19007]]

     administration of a product, the Secretary shall not impose 
     conditions that would restrict distribution or administration 
     of the product that is solely for the approved uses.'';
       (C) by amending paragraph (3) to read as follows:
       ``(3) Good manufacturing practice; prescription; 
     practitioner's authorization.--With respect to the emergency 
     use of a product for which an authorization under this 
     section is issued (whether for an unapproved product or an 
     unapproved use of an approved product), the Secretary may 
     waive or limit, to the extent appropriate given the 
     circumstances of the emergency--
       ``(A) requirements regarding current good manufacturing 
     practice otherwise applicable to the manufacture, processing, 
     packing, or holding of products subject to regulation under 
     this Act, including such requirements established under 
     section 501 or 520(f)(1), and including relevant conditions 
     prescribed with respect to the product by an order under 
     section 520(f)(2);
       ``(B) requirements established under section 503(b); and
       ``(C) requirements established under section 520(e).''; and
       (D) by adding at the end the following:
       ``(5) Existing authorities.--Nothing in this section 
     restricts any authority vested in the Secretary by any other 
     provision of this Act or the Public Health Service Act for 
     establishing conditions of authorization for a product.''; 
     and
       (6) in subsection (g)--
       (A) in the heading, by striking ``Revocation of 
     Authorization'' and inserting ``Review, Modification, and 
     Revocation of Authorization'';
       (B) in paragraph (1), by striking ``periodically review'' 
     and inserting ``review not less than every three years''; and
       (C) by adding at the end the following:
       ``(3) Modification.--The Secretary may modify an 
     authorization under this section or the conditions of such an 
     authorization, at any time, based on a review of the 
     authorization or new information that is otherwise obtained, 
     including information obtained during an emergency.''.

     SEC. 7. ADDITIONAL PROVISIONS RELATED TO MEDICAL PRODUCTS FOR 
                   EMERGENCY USE.

       (a) In General.--The Federal Food, Drug, and Cosmetic Act 
     is amended by inserting after section 564 (21 U.S.C. 360bbb-
     3) the following:

     ``SEC. 564A. ADDITIONAL PROVISIONS RELATED TO MEDICAL 
                   PRODUCTS FOR EMERGENCY USE.

       ``(a) Definitions.--For purposes of this section:
       ``(1) The term `product' means a drug, device, or 
     biological product.
       ``(2) The term `eligible product' means a product that is--
       ``(A) approved or cleared under this chapter or licensed 
     under section 351 of the Public Health Service Act; and
       ``(B) intended to be used to diagnose, prevent, or treat a 
     disease or condition involving a biological, chemical, 
     radiological, or nuclear agent or agents during--
       ``(i) a domestic emergency or military emergency involving 
     heightened risk of attack with such an agent or agents; or
       ``(ii) a public health emergency affecting national 
     security or the health and security of United States citizens 
     abroad.
       ``(b) Expiration Dating.--
       ``(1) In general.--The Secretary may extend the expiration 
     date and authorize the introduction or delivery for 
     introduction into interstate commerce of an eligible product 
     after the expiration date provided by the manufacturer if--
       ``(A) the eligible product is intended to be held for use 
     for a domestic, military, or public health emergency 
     described in subsection (a)(2)(B);
       ``(B) the expiration date extension is intended to support 
     the United States' ability to protect--
       ``(i) the public health; or
       ``(ii) military preparedness and effectiveness; and
       ``(C) the expiration date extension is supported by an 
     appropriate scientific evaluation that is conducted or 
     accepted by the Secretary.
       ``(2) Requirements and conditions.--Any extension of an 
     expiration date under paragraph (1) shall, as part of the 
     extension, identify--
       ``(A) each specific lot, batch, or other unit of the 
     product for which extended expiration is authorized;
       ``(B) the duration of the extension; and
       ``(C) any other requirements or conditions as the Secretary 
     may deem appropriate for the protection of the public health, 
     which may include requirements for, or conditions on, product 
     sampling, storage, packaging or repackaging, transport, 
     labeling, notice to product recipients, recordkeeping, 
     periodic testing or retesting, or product disposition.
       ``(3) Effect.--Notwithstanding any other provision of this 
     Act or the Public Health Service Act, an eligible product 
     shall not be considered an unapproved product (as defined in 
     section 564(a)(2)(A)) and shall not be deemed adulterated or 
     misbranded under this Act because, with respect to such 
     product, the Secretary has, under paragraph (1), extended the 
     expiration date and authorized the introduction or delivery 
     for introduction into interstate commerce of such product 
     after the expiration date provided by the manufacturer.
       ``(c) Current Good Manufacturing Practices.--
       ``(1) In general.--The Secretary may, when the 
     circumstances of a domestic, military, or public health 
     emergency described in subsection (a)(2)(B) so warrant, 
     authorize, with respect to an eligible product, deviations 
     from current good manufacturing practice requirements 
     otherwise applicable to the manufacture, processing, packing, 
     or holding of products subject to regulation under this Act, 
     including requirements under section 501 or 520(f)(1) or 
     applicable conditions prescribed with respect to the eligible 
     product by an order under section 520(f)(2).
       ``(2) Effect.--Notwithstanding any other provision of this 
     Act or the Public Health Service Act, an eligible product 
     shall not be considered an unapproved product (as defined in 
     section 564(a)(2)(A)) and shall not be deemed adulterated or 
     misbranded under this Act because, with respect to such 
     product, the Secretary has authorized deviations from current 
     good manufacturing practices under paragraph (1).
       ``(d) Mass Dispensing.--The requirements of section 503(b) 
     and 520(e) shall not apply to an eligible product, and the 
     product shall not be considered an unapproved product (as 
     defined in section 564(a)(2)(A)) and shall not be deemed 
     adulterated or misbranded under this Act because it is 
     dispensed without an individual prescription, if--
       ``(1) the product is dispensed during an actual emergency 
     described in subsection (a)(2)(B); and
       ``(2) such dispensing without an individual prescription 
     occurs--
       ``(A) as permitted under the law of the State in which the 
     product is dispensed; or
       ``(B) in accordance with an order issued by the Secretary.
       ``(e) Emergency Use Instructions.--
       ``(1) In general.--The Secretary, acting through an 
     appropriate official within the Department of Health and 
     Human Services, may create and issue emergency use 
     instructions to inform health care providers or individuals 
     to whom an eligible product is to be administered concerning 
     such product's approved, licensed, or cleared conditions of 
     use.
       ``(2) Effect.--Notwithstanding any other provisions of this 
     Act or the Public Health Service Act, a product shall not be 
     considered an unapproved product (as defined in section 
     564(a)(2)(A)) and shall not be deemed adulterated or 
     misbranded under this Act because of--
       ``(A) the issuance of emergency use instructions under 
     paragraph (1) with respect to such product; or
       ``(B) the introduction or delivery for introduction of such 
     product into interstate commerce accompanied by such 
     instructions during an emergency response to an actual 
     emergency described in subsection (a)(2)(B).''.
       (b) Risk Evaluation and Mitigation Strategies.--Section 
     505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355-1), is amended--
       (1) in subsection (f), by striking paragraph (7); and
       (2) by adding at the end the following:
       ``(k) Waiver in Public Health Emergencies.--The Secretary 
     may waive any requirement of this section with respect to a 
     qualified countermeasure (as defined in section 319F-1(a)(2) 
     of the Public Health Service Act) to which a requirement 
     under this section has been applied, if the Secretary 
     determines that such waiver is required to mitigate the 
     effects of, or reduce the severity of, an actual or potential 
     domestic emergency or military emergency involving heightened 
     risk of attack with a biological, chemical, radiological, or 
     nuclear agent, or an actual or potential public health 
     emergency affecting national security or the health and 
     security of United States citizens abroad.''.

     SEC. 8. PRODUCTS HELD FOR EMERGENCY USE.

       The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.) is amended by inserting after section 564A, as added by 
     section 7, the following:

     ``SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.

       ``It is not a violation of any section of this Act or of 
     the Public Health Service Act for a government entity 
     (including a Federal, State, local, and tribal government 
     entity), or a person acting on behalf of such a government 
     entity, to introduce into interstate commerce a product (as 
     defined in section 564(a)(4)) intended for emergency use, if 
     that product--
       ``(1) is intended to be held and not used; and
       ``(2) is held and not used, unless and until that product--
       ``(A) is approved, cleared, or licensed under section 505, 
     510(k), or 515 of this Act or section 351 of the Public 
     Health Service Act;
       ``(B) is authorized for investigational use under section 
     505 or 520 of this Act or section 351 of the Public Health 
     Service Act; or
       ``(C) is authorized for use under section 564.''.

     SEC. 9. 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) that the Secretary determines 
     to be a priority.
       ``(b) In General.--
       ``(1) Involvement of fda personnel in interagency 
     activities.--For the purpose of accelerating the development, 
     stockpiling, approval, clearance, and licensure of 
     countermeasures and products referred to in subsection

[[Page 19008]]

     (a), the Secretary shall expand the involvement of Food and 
     Drug Administration personnel in interagency activities with 
     the Assistant Secretary for Preparedness and Response 
     (including 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 Practices) to provide both 
     off-site and on-site technical assistance to the 
     manufacturers of countermeasures and products referred to in 
     subsection (a). On-site technical assistance shall be 
     provided upon the request of the manufacturer and at the 
     discretion of the Secretary if the Secretary determines that 
     the provision of such assistance would accelerate the 
     development, manufacturing, or approval, clearance, or 
     licensure of countermeasures and products referred to in 
     subsection (a).
       ``(c) Agency Interaction With Security Countermeasure 
     Sponsors.--
       ``(1) In general.--For security countermeasures (as defined 
     in section 319F-2 of the Public Health Service Act) that are 
     procured under such section 319F-2--
       ``(A) the Secretary shall establish a process for frequent 
     scientific feedback and interactions between the Food and 
     Drug Administration and the security countermeasure sponsor 
     (referred to in this subsection as the `sponsor'), designed 
     to facilitate the approval, clearance, and licensure of the 
     security countermeasures;
       ``(B) such feedback and interactions shall include meetings 
     and, in accordance with subsection (b)(2), on-site technical 
     assistance; and
       ``(C) at the request of the Secretary, the process under 
     this paragraph shall include participation by the Food and 
     Drug Administration in meetings between the Biomedical 
     Advanced Research and Development Authority and sponsors on 
     the development of such countermeasures.
       ``(2) Regulatory management plan.--
       ``(A) In general.--The process established under paragraph 
     (1) shall allow for the development of a written regulatory 
     management plan (in this paragraph referred to as the `plan') 
     for a security countermeasure (as defined in paragraph (1)) 
     in accordance with this paragraph.
       ``(B) Proposal and finalization of plan.--In carrying out 
     the process under paragraph (1), the Secretary shall direct 
     the Food and Drug Administration, upon submission of a 
     written request by the sponsor that includes a proposed plan 
     and relevant data and future planning detail to support such 
     a plan, to work with the sponsor to agree on a final plan 
     within a reasonable time not to exceed 90 days. The basis for 
     this agreement shall be the proposed plan submitted by the 
     sponsor. Notwithstanding the preceding sentence, the 
     Secretary shall retain full discretion to determine the 
     contents of the final plan or to determine that no such plan 
     can be agreed upon. If the Secretary determines that no final 
     plan can be agreed upon, the Secretary shall provide to the 
     sponsor, in writing, the scientific or regulatory rationale 
     why such agreement cannot be reached. If a final plan is 
     agreed upon, it shall be shared with the sponsor in writing.
       ``(C) Contents.--The plan shall include an agreement on the 
     nature of, and timelines for, feedback and interactions 
     between the sponsor and the Food and Drug Administration, 
     shall provide reasonable flexibility in implementing and 
     adjusting the agreement under this paragraph as warranted 
     during the countermeasure development process, and shall 
     identify--
       ``(i) the current regulatory status of the countermeasure, 
     an assessment of known scientific gaps relevant to approval, 
     clearance, or licensure of the countermeasure, and a proposed 
     pathway to approval, clearance, or licensure of the 
     countermeasure;
       ``(ii) developmental milestones whose completion will 
     result in meetings to be scheduled within a reasonable time 
     between the applicable review division of the Food and Drug 
     Administration and the sponsor;
       ``(iii) sponsor submissions that will result in written 
     feedback from the review division within a reasonable time;
       ``(iv) feedback by the Food and Drug Administration 
     regarding the data required to support delivery of the 
     countermeasure to the Strategic National Stockpile under 
     section 319F-2 of the Public Health Service Act;
       ``(v) feedback 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
       ``(vi) other issues that have the potential to delay 
     approval, clearance, or licensure.
       ``(D) Changes.--Changes to the plan shall be made by 
     subsequent agreement between the Secretary and the sponsor. 
     If after reasonable attempts to negotiate changes to the plan 
     the Secretary and the sponsor are unable to finalize such 
     changes, the Secretary shall provide to the sponsor, in 
     writing, the scientific or regulatory rationale why such 
     changes are required or cannot be included in the plan.
       ``(3) 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 paragraphs (1) and (2) 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.--
       ``(1) In general.--Not later than 1 year 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, clearance, or licensure of 
     countermeasures and products referred to in subsection (a) 
     when human efficacy studies are not ethical or feasible.
       ``(2) Authority to extend deadline.--The Secretary may 
     extend the deadline for providing final guidance under 
     paragraph (1) by not more than 6 months upon submission by 
     the Secretary of a report on the status of such guidance to 
     the Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate.
       ``(e) Biennial Report.--Not later than January 1, 2013, and 
     every 2 years 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 2 fiscal years, 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 review 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) a description of other measures that, as determined 
     by the Secretary, are appropriate to determine the efficiency 
     of the regulatory teams described in paragraph (3); and
       ``(7) the regulatory science priorities that relate to 
     countermeasures or products referred to in subsection (a) and 
     which the Food and Drug Administration is addressing and the 
     progress made on these priorities.''.
       (b) Special Protocol Assessment.--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 efficacy trials and any associated clinical 
     trials that in combination are intended to form the primary 
     basis of an effectiveness claim for a countermeasure or 
     product referred to in section 565(a) 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.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Pennsylvania (Mr. Pitts) and the gentleman from New Jersey (Mr. 
Pallone) each will control 20 minutes.
  The Chair recognizes the gentleman from Pennsylvania.


                             General Leave

  Mr. PITTS. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials into the Record.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Pennsylvania?
  There was no objection.
  Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.
  H.R. 2405, introduced by my colleague Mike Rogers from Michigan, 
would reauthorize certain provisions of the Project Bioshield Act of 
2004 and the Pandemic and All-Hazards Preparedness Act of 2006. These 
two laws help protect the United States against attacks from chemical, 
biological, radiological, and nuclear weapons.

[[Page 19009]]

  Project Bioshield authorized funds for the purchase of medical 
countermeasures through the Special Reserve Fund and enabled the 
Secretary of Health and Human Services to authorize the emergency use 
of medical products. PAHPA created the Biodefense Advanced Research and 
Development Authority within HHS to help with the development of 
medical countermeasures and to ensure the communication between HHS and 
the developers of the medical countermeasures. PAHPA also created a 
position at HHS to lead the government's efforts on the chemical, 
biological, radiological, and nuclear weapons preparedness and 
response, the Assistant Secretary for Preparedness and Response.
  Some of these key provisions expired at the end of FY 2011. Since the 
terrorist attacks of 9/11, we have become more aware of the dangers our 
country faces and of the lengths to which some may go to inflict harm 
on us. These provisions must be reauthorized, so I would urge all 
Members to support this critical piece of legislation.
  I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  I am pleased to rise in support of H.R. 2405, the Pandemic and All-
Hazards Preparedness Reauthorization Act of 2011. This bill is an 
opportunity to build a more prepared and resilient public health 
infrastructure. We all know very well that our Nation continues to face 
threats that require an ongoing commitment to public health and 
emergency preparedness, which is why, over the past 10 years, this 
Congress has placed a high priority on biodefense.
  In 2004, with tremendous bipartisan support, we passed the Project 
Bioshield Act. Democrats and Republicans worked together to establish a 
process that would help our Nation respond to bioterrorism threats and 
attacks. We then identified some shortfalls and, in 2006, worked to 
amend the program by passing the Pandemic and All-Hazards Preparedness 
Act, also known as PAHPA. Specifically, PAHPA provided the Department 
of Health and Human Services with the additional authorities and 
resources necessary to rapidly develop drugs and vaccines to protect 
citizens from various medical incidents, whether accidental, such as 
H1N1 outbreaks, or those that are deliberate, such as anthrax attacks.
  The programs and activities first established in both the 2004 
Project Bioshield Act and the 2006 PAHPA codified and expanded the 
Federal Government's support for public health preparedness. As a 
result of these bills and the investments that followed, our Nation is 
better equipped to respond to bioterrorism threats and attacks.
  H.R. 2405 will now help to build on that progress. The bill further 
facilitates the development of medical countermeasures, and it bolsters 
the Nation's public health preparedness infrastructure. It strengthens 
and clarifies the position of Assistant Secretary for Preparedness and 
Response, who has led the Federal Government's efforts and attempts to 
improve coordination and accountability.
  I was especially supportive of the bill's provisions to identify and 
dedicate the FDA's role in hazardous events. H.R. 2405 enhances the 
flexibility of FDA while strengthening their emergency use 
administrative functions.

                              {time}  1330

  These revisions are a significant step forward on a framework for FDA 
to develop better policies and guidance in emergency situations.
  In addition, I was appreciative of the bipartisan effort to address 
the special needs of pediatric populations in emergency situations. It 
was clear that there were some gaps in our Nation's public health 
emergency strategy for children, and I'm confident we took an 
appropriate approach for filling in these gaps.
  So I really want to thank Representative Mike Rogers and 
Representative Gene Green and their staffs, who authored the base bill 
and have continued to work to strengthen its provisions.
  I would also like to thank the staff of the Energy and Commerce 
Committee and, of course, my chairman, Mr. Pitts, who collaborated in a 
bipartisan manner to further enhance the bill. They have worked hard to 
accomplish the goals of our Members, as well as stakeholders, and to 
strengthen its provisions. It's been a good bipartisan process and one 
that I think should be emulated in our subcommittee and full committee 
in the future.
  I would urge all Members to support H.R. 2405.
  I reserve the balance of my time.
  Mr. PITTS. Mr. Speaker, I yield such time as he may consume to the 
gentleman from Michigan (Mr. Rogers), the prime sponsor of the 
legislation.
  Mr. ROGERS of Michigan. Thank you, Mr. Pitts, and thank you for your 
leadership on the committee to allow this bill to come to the floor 
today. Good news, Mr. Speaker: this bill is bipartisan, it's fiscally 
responsible, and it will make a positive impact on our Nation's 
national security.
  It's been more than 10 years since
9/11 and the anthrax attacks that followed. And while we haven't had a 
successful terrorist attack on U.S. soil, our enemies are still working 
every day to kill innocent Americans. Today the threat of bioterrorism 
remains very real.
  Earlier this year, the bipartisan Graham-Talent Commission warned 
that the United States it is still ``vulnerable to a large-scale 
biological attack.''
  Thankfully, we have spent the last decade preparing for chemical, 
biological, radiological, and nuclear threats by developing and 
stockpiling numerous medical countermeasures to protect American 
citizens in case of such an attack. Because of these efforts, we now 
have numerous vaccines and treatments in the Strategic National 
Stockpile that will save lives, and thousands of lives, in the event of 
such an attack.
  But we have more work to do to be prepared. H.R. 2405 is a 
bipartisan, fiscally responsible bill that will reauthorize successful 
biodefense programs at the Department of Health and Human Services 
while also making some key changes to our Nation's biodefense strategy.
  In 2004 Congress passed Project BioShield, which created a market 
guarantee that prompted the private sector to develop countermeasures 
for the Federal Government. Because the government is the only 
purchaser of these countermeasures, it was important to show the 
private sector we were committed to developing and eventually 
purchasing these products for stockpile.
  Project BioShield Special Reserve Fund has been a critical tool to 
protect our country against an attack, and this legislation will 
reauthorize the fund for 5 additional years to continue the Federal 
Government's commitment to procurement of medical countermeasures. 
Importantly, this legislation reaffirms that the Special Reserve Fund 
should only be used for chemical, biological, radiological, and nuclear 
countermeasure procurement. This is a national security priority, and 
these funds should never be diverted for other purposes.
  In 2006, Congress created a Biomedical Advanced Research and 
Development Authority, called BARDA, which helped bridge what many 
termed the ``valley of death'' that had prevented many countermeasure 
developers from being successful. BARDA was created because we 
recognize that most of the CBRN countermeasures do not yet exist and 
medical development countermeasure is a risky, expensive and lengthy 
process.
  BARDA bridges the funding gap between early-stage research and the 
ultimate procurement of products from the SRF fund from the national 
stockpile. H.R. 2405 reauthorizes BARDA for 5 years.
  In 2006, we also created a unique set of public health programs to 
assist hospitals, local public health departments, and first responders 
in their preparedness efforts. Under H.R. 2405, these programs have 
been reauthorized for an additional 5 years so that we can continue to 
strengthen our preparedness infrastructure so critical for prevention 
and dealing with any possible attack.
  H.R. 2405 also strengthens the role of the HHS Assistant Secretary of 
Preparedness and Response. We need to

[[Page 19010]]

have one leader at HHS that coordinates countermeasure development and 
stockpiling across all agencies. This bill does that.
  Finally, this bill includes important reforms to the Food and Drug 
Administration, the FDA. The bill strengthens FDA's role in reviewing 
medical products for national security priorities.
  I believe that we've identified biological threats and spent millions 
in taxpayers' funds to develop countermeasures. The FDA must take a 
lead role in getting these countermeasures approved.
  While we can use many of these products without FDA approval through 
an emergency-use authorization, the FDA licensure is hugely important 
and sends an important signal to developers of these new hopeful 
technologies and immunizations working on next-generation medical 
countermeasures.
  Simply put, medical countermeasures for national security priorities 
cannot continue to be treated the same way as the next Viagra or 
Lipitor. FDA must accelerate their review and approval.
  It's important for Members to know that this legislation, again, is 
fiscally responsible. H.R. 2405 does not create any new Federal 
programs or increase spending in any existing programs. I am pleased 
CBO has confirmed this in their score. H.R. 2405 creates a 5-year 
reauthorization of the biodefense programs we know are working while 
making critical policy changes at HHS to strengthen countermeasure 
development and public health preparedness.
  I would like to thank my colleagues on the Energy and Commerce 
Committee for their hard work on this bipartisan legislation. Mr. 
Upton, Mr. Pitts, Mr. Waxman, Mr. Pallone, and their staffs have spent 
several months helping us develop a bipartisan bill that can be signed 
into law. I want to especially thank my friends, Gene Green, Sue 
Myrick, and Anna Eshoo for their work to advance this legislation; and 
I appreciate your work and counsel along the way, Mr. Green.
  I hope we never have to use these countermeasures, Mr. Speaker; but 
they are critical to the assurance that the public will be protected 
from an attack, and we must continue to speed development and 
strengthen our national stockpile. Simply put, we must always be 
prepared.
  I would urge the strong support of H.R. 2405.
  Mr. PALLONE. Mr. Speaker, I yield such time as he may consume to one 
of the authors of the bill, the gentleman from Texas (Mr. Gene Green).
  Mr. GENE GREEN of Texas. Mr. Speaker, as a personal aside, this 
probably won't be the headline on the 6 o'clock news tonight around the 
country because we're actually agreeing on something, and I think I can 
associate myself with the remarks of my colleague, the primary sponsor 
of this bill, as well as he could associate with mine, Mr. Pallone, and 
Mr. Pitts.
  But I rise today in strong support of H.R. 2405, the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2011, which will 
reauthorize certain provisions of the Project BioShield Act of 2004 and 
the Pandemic and All-Hazards Preparedness Act of 2006, and I'm proud to 
be an original cosponsor of this legislation.
  This legislation was initially passed by Congress to help the U.S. 
develop medical countermeasures against chemical, biological, 
radiological, and nuclear terrorism agents to provide a mechanism for 
Federal acquisition of these newly developed countermeasures.
  Our Nation remains vulnerable to these threats because many of the 
vaccines and medicines that are needed to protect our citizens do not 
exist. Developing and stockpiling these medical countermeasures require 
time, resources and research, all of which will be provided under this 
legislation before us today.
  As my colleague from Michigan said, it may not be the bestseller on 
the market, like so many other pharmaceuticals, but this is something 
that our country needs.
  H.R. 2405 is important to me because the University of Texas Medical 
Branch-Galveston National Laboratory is literally in the backyard of 
our congressional district. The Galveston National Lab is the only BSL-
4 lab located on a university campus.
  At the lab, the scientists conduct research and develop therapies, 
vaccines, and diagnostic tests for naturally-occurring emerging 
diseases such as SARS and avian influenza, as well as for microbes that 
may be employed by terrorists.
  This is exactly the type of research we hope to encourage under the 
Pandemic and All-Hazards Preparedness Reauthorization Act. As an 
original cosponsor of H.R. 2405 with Mr. Rogers, I'm really pleased 
with how quickly we moved this rare bipartisan piece of legislation. I 
want to thank Mr. Rogers, Chairman Upton, Ranking Member Waxman and 
Ranking Member Pallone, along with the chair of our Health 
Subcommittee, Mr. Pitts, Mrs. Myrick, Ms. Eshoo, and Mr. Markey for 
their work on H.R. 2405.
  I strongly urge my colleagues to vote ``yes.''

                              {time}  1340

  Mr. PITTS. I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from 
California (Mrs. Capps).
  Mrs. CAPPS. Mr. Speaker, I rise in support of H.R. 2405, the Pandemic 
and All-Hazards Preparedness Reauthorization Act. But I want to take 
this time to discuss a critical health issue that Congress must address 
before the year is out--fixing the sustainable growth rate issue.
  Medicare physicians are facing steep reimbursement cuts of nearly 30 
percent. And to let these cuts go into effect will harm not only them 
and their employees, but our seniors as well. That's why I have been a 
longtime supporter of efforts to postpone SGR cuts and continue to work 
on a permanent fix.
  We here in the House passed legislation to do just that through our 
version of health care reform. And here we are again, just weeks from 
the next scheduled cut with an opportunity to craft a bipartisan 
solution to an issue that both sides of the aisle say they care about. 
But there is no workable plan in sight.
  Instead, it is reported that any fix on the House side will come with 
indefensible strings attached, pitting doctors' salaries against 
seniors' benefits, Federal workers, and important cost-saving 
prevention programs. To be clear, SGR must be fixed permanently, but 
the idea of stripping other critical health care funding to pay for it, 
ideas that will not see the light of day in the Senate, is like robbing 
Peter to pay Paul. It is disingenuous to our Nation's doctors, and it 
is an indefensible action which will harm our seniors.
  So I urge the majority to stop playing politics with the health and 
well-being of our seniors and to work together to achieve a meaningful 
and realistic fix.
  Mr. PITTS. Mr. Speaker, I would tell the gentleman from New Jersey 
that I have no other speakers.
  Mr. PALLONE. I have no additional speakers. I urge support for this 
legislation. It is truly bipartisan.
  I yield back the balance of my time.
  Mr. PITTS. Mr. Speaker, this is good, bipartisan legislation. I would 
like to thank Mr. Pallone, Mr. Green, Mr. Waxman, along with our side 
of the aisle, for developing and helping move this bipartisan 
legislation. I urge my colleagues to support it, and I yield back the 
balance of my time.
  Mr. PAULSEN. Mr. Speaker, I rise in support of the Pandemic and All-
Hazards Preparedness Reauthorization Act that aims to bolster the 
nation's public health preparedness infrastructure.
  In particular, I want to thank Congressman Rogers for including key 
provisions that enhance the nation's ability to care for the critically 
ill and injured in the aftermath of a public health emergency. This 
includes section two that adds the critical care system to the National 
Health Security Strategy's medical preparedness goals, to ensure that 
critical care is prioritized in planning efforts to increase 
preparedness in respect to public health emergencies.
  We must understand the significant role critical care medicine plays 
in providing high quality health care for the critically ill and 
injured in the context of public health preparedness.

[[Page 19011]]

  The 2009 H1N1 pandemic highlighted some of the deficiencies in 
current federal critical care preparedness efforts, as hospitals and 
intensive care units faced very real shortages of ventilators and 
federal officials scrambled to identify solutions to mitigate this 
potential life threatening situation.
  In order to ensure that the nation's critical care system is 
structured to provide the highest quality and most efficient health 
care, including during a national health emergency, I joined with 
Congresswoman Baldwin earlier this year to introduce the Critical Care 
Assessment and Improvement Act (H.R. 971). This legislation is designed 
to identify gaps in the current critical care delivery model and 
bolster capabilities to meet future demand. Today's bill includes 
provisions that reflect some of the national preparedness priorities 
from in H.R. 971.
  We must ensure that critical care medicine is given sufficient 
consideration by the Administration in respect to disaster preparedness 
efforts.
  Ms. BALDWIN. Mr. Speaker, I rise in support of the Pandemic and All-
Hazards Preparedness Reauthorization Act, H.R. 2405, a measure that 
will improve our nation's medical preparedness and response 
capabilities.
  I am especially pleased to see that this bill takes important steps 
to ensure that our medical response systems are prepared to care for 
the critically ill and injured in the aftermath of a public health 
emergency.
  As you can imagine, when we face a health emergency such as a flu 
pandemic, the critical care delivery system is an integral component of 
our nation's medical response. Yet, up to this point, critical care 
medicine has been largely under-contemplated in our national health 
policy.
  Earlier this year, I introduced the bipartisan Critical Care 
Assessment Act, H.R. 971, with my colleague from Minnesota, Erik 
Paulsen. This measure seeks to identify gaps in the current critical 
care delivery model and bolster our capabilities to meet future 
demands.
  I am pleased that the measure before us today includes two important 
provisions from my bill to improve federal disaster preparedness 
efforts to care for the critically ill and injured.
  Notably, the reauthorization bill adds critical care to the 
priorities within the nation's medical preparedness goals. When a 
natural disaster strikes or a pandemic sweeps the nation, the demands 
on critical care increase exponentially, and I am pleased to see this 
language that recognizes the importance of treating the critically ill 
and injured in a public health emergency.
  Additionally, the reauthorization bill improves efforts to ensure 
that the systems we have in place to address surge capacity will work 
effectively and efficiently during an emergency. Specifically, the bill 
includes language to provide for periodic evaluation and testing of the 
databases intended to ensure medical surge capacity.
  As we learned during Hurricane Katrina and the 2009 H1N1 pandemic, 
having a system in place for the effective deployment of needed medical 
personnel and supplies is vital for the care of the critically ill and 
injured.
  I would like to thank Chairman Upton, Chairman Pitts, and my 
colleagues on both sides of the aisle for working with me to recognize 
the importance of critical care preparedness by including these 
important provisions. I look forward to continuing to work to ensure we 
have a robust critical care infrastructure.
  Mr. WAXMAN. Mr. Speaker, I rise today in strong support of H.R. 2405, 
the Pandemic and All-Hazards Preparedness Reauthorization Act of 2011. 
I am pleased to report that this legislation represents a bipartisan 
effort to make certain that our nation is prepared to successfully 
manage the effects of natural disasters, infectious disease outbreaks, 
and acts of bioterrorism.
  The Pandemic and All-Hazards Preparedness Reauthorization Act 
reauthorizes and makes minor--but important--improvements to programs 
and activities first established in the 2004 Project Bioshield Act and 
the 2006 Pandemic and All-Hazards Preparedness Act, also known as 
PAHPA. Let me highlight three provisions that deserve particular 
attention.
  First, with respect to the Food and Drug Administration, we took 
great care to ensure that the agency is focusing on the medical 
countermeasures--or products that combat chemical, biological, 
radioactive, and nuclear agents--of highest importance. As we all know, 
if everything is given priority, then nothing is truly a priority. H.R. 
2405 requires FDA to work with industry on industry-submitted 
regulatory management plans for prioritized countermeasures to 
facilitate scientific exchanges between the FDA and product sponsors to 
streamline our ability to make these products available.
  Second, the legislation makes improvements to the nation's blueprint 
for public health preparedness and response activities that will 
enhance the ability of the health care system to respond to mass 
casualty emergencies.
  Finally, H.R. 2405 continues investment in state and local public 
health departments to ensure we have the requisite infrastructure to 
respond to public health threats.
  I'd like to thank Congressman Rogers and Congressman Green--the 
sponsors of the legislation--for their hard work on H.R. 2405. I'd also 
like to recognize Congresswoman Myrick, Congresswoman Eshoo, and 
Congressman Markey who contributed a great deal to the Committee's work 
on this bill.
  I understand that Senator Burr and Senator Casey have recently 
introduced comparable legislation in the Senate. I look forward to 
working with our Senate colleagues on this issue and sending final 
PAHPRA legislation to the President for his signature.
  I urge my colleagues to join me in supporting this bill.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Pennsylvania (Mr. Pitts) that the House suspend the 
rules and pass the bill, H.R. 2405, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

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