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

                                                 Union Calendar No. 189
112th CONGRESS
  1st Session
                                H. R. 2405

                          [Report No. 112-286]

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

                           November 16, 2011

             Additional sponsors: Mr. Burgess and Ms. Eshoo

                           November 16, 2011

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
 [For text of introduced bill, see copy of bill as introduced on June 
                               28, 2011]


_______________________________________________________________________

                                 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. 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;

                                                    ``(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)'';
            (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 
                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 (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.''.
                                                 Union Calendar No. 189

112th CONGRESS

  1st Session

                               H. R. 2405

                          [Report No. 112-286]

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                           November 16, 2011

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed