[Federal Register Volume 74, Number 153 (Tuesday, August 11, 2009)]
[Notices]
[Pages 40189-40199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19199]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES


The National Biodefense Science Board (NBSB), a Federal Advisory 
Committee to the Secretary; Request for Public Comment

AGENCY: Department of Health and Human Services, Office of the 
Secretary.

ACTION: Request for public comment.

-----------------------------------------------------------------------

SUMMARY: The U.S. Department of Health and Human Services is hereby 
giving notice that the National Biodefense Science Board (NBSB) Medical 
Countermeasure Markets and Sustainability Working Group is requesting 
public comment to their working document, ``Inventory of Issues 
Constraining or Enabling Industry Involvement in Medical Countermeasure 
Efforts''. The inventory (or grid) includes factors that may discourage 
industry involvement or partnering with the U.S. Government in medical 
countermeasure development efforts, reported constraints to industry 
involvement, and potential solutions for relief from a particular 
constraint. The inventory has been catalogued by financial, 
legislative, scientific, human capital, regulatory, and societal 
elements. The Working Group wishes to solicit comment, feedback, and 
guidance from members of industry, other government agencies, and the 
public at large for consideration by the Working Group to strengthen 
and refine the document prior to its public presentation to the NBSB at 
the scheduled Fall 2009 public meeting of the Board.

DATES: The public is asked to submit comments by October 30, 2009, to 
the NBSB e-mail box ([email protected]) in order to be considered by the 
Working Group in preparing the final document.

[[Page 40190]]


ADDRESSES: 
    Availability of Materials: Requests for a copy of the Inventory and 
accompanying ``Comment Revision Form'' should be made to the NBSB's e-
mail box at [email protected] with ``M&S-WG Inventory Request'' in the 
subject line. All comments and/or recommendations for improvement to 
the Inventory should be made on the ``Comment Revision Form'' enclosed 
with the inventory document.
    Procedures for Providing Public Input: Interested members of the 
public may submit written comments and/or suggestions, using the 
``Comment Revision Form,'' to the NBSB's e-mail box at [email protected], 
with ``M&S-WG Inventory Comments'' in the subject line and should be 
received no later than October 30, 2009. Individuals providing comment 
or suggestions will be asked to provide their name, title, and 
organization. All comments received will be posted without change to 
http://www.hhs.gov/aspr/omsph/nbsb/, including any personal or 
commercial information provided.

FOR FURTHER INFORMATION, CONTACT: Donald Malinowski, M.Sc., HHS/ASPR/
NBSB, 330 C St., SW., 5118, Washington, DC 20201, 202-205-
4761, [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to section 319M of the Public 
Health Service Act (42 U.S.C. 247d-7f) and section 222 of the Public 
Health Service Act (42 U.S.C. 217a), the Department of Health and Human 
Services established the National Biodefense Science Board. The Board 
shall provide expert advice and guidance to the Secretary on 
scientific, technical, and other matters of special interest to the 
Department of Health and Human Services regarding current and future 
chemical, biological, nuclear, and radiological agents, whether 
naturally occurring, accidental, or deliberate. The Board may also 
provide advice and guidance to the Secretary on other matters related 
to public health emergency preparedness and response.

    Dated: July 29, 2009.
Nicole Lurie,
Assistant Secretary for Preparedness and Response, Rear Admiral, U.S. 
Public Health Service.

National Biodefense Science Board

Markets & Sustainability Working Group Working Document

``Inventory of Issues Constraining or Enabling Industrial Involvement 
With Medical Countermeasure Development''
    Request for Public Comment Published in Federal Register June 1, 
2009.

Inventory of Issues Constraining or Enabling Industrial Involvement 
with Medical Countermeasure Development

    Introduction: The National Biodefense Science Board (NBSB) Medical 
Countermeasure Markets and Sustainability Working Group (M&S-WG) has 
posted a request for public comment in the Federal Register to solicit 
comment, feedback, and guidance from members of industry, other 
government agencies, and the public at large on their working document, 
``Inventory of Issues Constraining or Enabling Industry Involvement in 
Medical Countermeasure Efforts.'' Posting of the working document in 
the Federal Register will serve to solicit and obtain public comment 
for consideration by the Working Group to strengthen and refine the 
document. The Working Group plans to present the document to the NBSB 
at the scheduled Fall 2009 public meeting of the Board.
    Background: There exists a variety of limitations and barriers to 
biotechnology and pharmaceutical companies'' involvement in the 
biosecurity and biodefense efforts of the U.S. Government (USG), most 
notably medical countermeasure advanced research and development 
programs coordinated by the Department of Defense (DoD) and the 
Department of Health and Human Services (DHHS). Make-up of the medical 
countermeasure development efforts has been called fragmented, with 
confusing approaches used. To delineate and simplify the complexities 
of USG endeavors in medical countermeasure development, and the 
interactions between government agencies and private industry, the NBSB 
Markets & Sustainability Working Group (M&S-WG) assembled the enclosed 
inventory (or grid) of issues. This inventory includes factors that may 
discourage industry involvement or partnering with the USG in medical 
countermeasure development efforts, reported constraints to industry 
involvement, and potential solutions for relief from a particular 
constraint. The inventory has been catalogued by financial, 
legislative, scientific, human capital, regulatory, and societal 
elements.
    The public is encouraged to consider submitting comments and/or 
recommendations on the content of this inventory. Requests for a copy 
of the inventory and accompanying Comment Revision Form should be sent 
to the NBSB's e-mail box at [email protected] with ``M&S-WG Inventory 
Request'' in the subject line. All comments and/or recommendations for 
improvement to the inventory grid should be made on the Comment 
Revision Form enclosed with the inventory document. Comments and/or 
recommendations are to be submitted to the NBSB's e-mail box at 
[email protected] with ``M&S-WG Inventory Comments'' in the subject line and 
should be received no later than October 30, 2009.

NBSB Markets & Sustainability Work Group 18 May 09

Observations, Adapted From June 08 NBSB Meeting

    Business Planning:
    [mshbox] Contracting with some portions of the USG can be slow, 
unwieldy, expensive, and opaque.
    [mshbox] Lack of clarity increases industry risk.
    [mshbox] Procurement size, warm-base requirements, length of 
review, etc.
    [mshbox] Lack of transparency increases industry risk.
    [mshbox] Contract review process, rate of issuance of new 
proposals, requirement generation.
    [mshbox] With a contract in place, situation improves.
    [mshbox] HHS viewed as cooperative, helpful, responsible and 
responsive.
    [mshbox] Perceived lack of coordination between development 
activities and regulatory responsibilities remains a concern to 
industry.
    Regulatory:
    [mshbox] Lack of clarity regarding usable product definitions, 
seeming differences in FDA approaches to providing guidance to 
industry.
    [mshbox] Industry reliance upon USG for key components of licensure 
submissions can lead to lack of accountability.
    [mshbox] Disease studies, toxicology reports, etc.
    Funding, Stability, Reliability, Predictability:
    [mshbox] Advanced Development needs more dedicated funding, 
separate from BioShield funding.
    [mshbox] BioShield remains a funded procurement device, not an 
advanced-development mechanism.

[[Page 40191]]

    [mshbox] Advanced development efforts would benefit from 
contracting flexibility.
    [mshbox] Cost-plus-fee contracting flexibility is appropriate for 
advanced development and would reduce risk.
    [mshbox] Multiyear funding.
    [mshbox] Drug development and corporate investment/planning is 
long-term process, multiyear funding with carry-over authority, with 
multi-year contracting authority would signal USG commitment and 
increase industry sense of long-term stability.
    [mshbox] Project BioShield expires in 2013 and will need to be 
reauthorized and funded.
    [mshbox] Five years not a long time in drug-development process.
    [mshbox] BioShield funds should not be diverted to fund other 
initiatives.
    [mshbox] Inadequate funding delays the journey to MCM licensure.
    [mshbox] Initiate additional program against emerging diseases, 
modeled after pandemic program.
    Next Steps for WG :
    [mshbox] Continue to identify obstacles to greater industry 
participation in MCM development.
    [mshbox] Make recommendations where appropriate.
    [mshbox] Identify incentives to encourage greater industry 
participation in MCM development.
    [mshbox] Make recommendations where appropriate.
    [mshbox] Consider alternative models for MCM development.
    [mshbox] Do other models ensure national and public-health security 
while more efficiently using limited resources?
    Barriers Hindering Partnership: Opportunity cost (distractions from 
commercial business), economics (e.g. margins, volumes), product 
liability, uncertainty over sustained funding, ambiguous governance, 
competing public-health alternatives (e.g., needs of developing world), 
finite human capital, complexity of working with USG, obligations 
during crisis.
    Incentives Encouraging Partnership: Reliable access to excess 
capacity (e.g., for redundant capacity or developing-world projects), 
tax credits, patent-term extensions, grants, priority-review vouchers, 
preferred customer/vendor status with USG, product licensing rights, 
larger pool of scientists and engineers, public good, long-term 
contracts, intellectual-property development.

 Inventory of Issues Constraining or Enabling Industrial Involvement With Medical Countermeasure Development 18
                                                     May 09
----------------------------------------------------------------------------------------------------------------
                                                                   Approach/  advantages/
  Row        Problem/category       Potential solution             action           Problem/limitation
                   Column 1.....  Column 2.....  Column 3.....  Column 4
----------------------------------------------------------------------------------------------------------------
                                               Financial Elements
----------------------------------------------------------------------------------------------------------------
1................  Row 1; Column 1.......  Row 1; Column 2.......  Row 1; Column 3.......  Row 1; Column 4.
                   Capital requirements    Increase financial      Increased federal       Risk of distraction
                    to establish safety,    return after risking    funding for advanced    of large industry
                    efficacy, validated     capital to industry-    development, in the     partners from
                    manufacture.            standard rates.         form of cost-           commercial mission
                                           Reduce requirement for   reimbursement           or dilution of
                                            private capital for     contracts and           effort [potential
                                            advanced development.   rewarding private-      conflict with
                                                                    capital investments     fiduciary
                                                                    with milestone          responsibility to
                                                                    payments and at         shareholders of
                                                                    procurement.            publicly traded
                                                                                            companies].
----------------------------------------------------------------------------------------------------------------
2................  Row 2; Column 1.......  Row 2; Column 2a......  Row 2; Column 3a......  Row 2; Column 4.
                   Risk of technical       Decentralized           Reimbursement of        Lack of interest,
                    failure of vaccine      discovery/centralized   development costs at    given opportunity
                    development effort.     development and         cost +15%, with         costs Congressional
                                            manufacture.            return-on-working-      tolerance for
                                                                    capital at 22%, and     anticipatable
                                                                    cost-of-money-for-      frustrations is
                                                                    capital at 15%.         unknown.
                                           Row 2; Column 2b......  Row 2; Column 3b......
                                           Evaluation of whether   Provides support early
                                            indirect-cost           in process.
                                            reimbursement greater
                                            than 100% may be
                                            appropriate.
                                           Assistance with
                                            calculating indirect
                                            cost rates (for
                                            companies that have
                                            never done so
                                            before)..
----------------------------------------------------------------------------------------------------------------
3................  Row 3; Column 1.......  Row 3; Column 2a......  Row 3; Column 3a......
                   Tax incentives........  Enhance current         Currently, 20% for
                                            incremental R&D tax     qualified R&D
                                            credit (increase,       expenses and 50% for
                                            make refundable).       clinical-trial
                                                                    expenses.
                                           Row 3; Column 2b......  Row 3; Column 3b......  Row 3; Column 4.
                                           New investment tax      Enhance net revenue...  Not yet authorized.
                                            credit (20%) for
                                            construction of new
                                            R&D and manufacturing
                                            facilities for
                                            biosecurity and
                                            emerging-infectious
                                            disease purposes
                                            (with refundable and/
                                            or transferable
                                            provisions).
----------------------------------------------------------------------------------------------------------------
4................  Row 4; Column 1.......  Row 4; Column 2.......  Row 4; Column 3.......  Row 4; Column 4.

[[Page 40192]]

 
                   Revenue enhancements    Enhance current         Current statutory       Note: Orphan drug tax
                    based on Intellectual   product or use patent-  formula: Patent         credit applies to
                    Property.               term restoration and/   extension               vaccines only if
                                            or extension (revise    supplemented by [\1/    less than 200,000
                                            formula).               2\ time from IND to     vaccinated
                                           Allow full patent-term   filing BLA + full       recipients
                                            extension for           time from BLA filing    anticipated.
                                            licensed products       to FDA approval/
                                            that gain CBRN or       licensure].
                                            emerging disease       Currently, 5 years of
                                            application (akin to    market exclusivity is
                                            adding pediatric        provided to New
                                            indication).            Chemical Entities
                                           Allow transfer of        (NCEs) but not
                                            patent-term extension   biologicals via Hatch-
                                            to another product or   Waxman Act and 7
                                            company                 years of market
                                            (``wildcard'').         exclusivity is
                                           Market exclusivity:      provided via Orphan
                                            Increase term of        Drug Act.
                                            market exclusivity to
                                            ~ 12-15 years and
                                            extend it to
                                            biologicals (as does
                                            Orphan Drug Act).
----------------------------------------------------------------------------------------------------------------
5................  Row 5; Column 1.......  Row 5; Column 2.......  Row 5; Column 3.......  Row 5; Column 4.
                   Priority-Review         Make applicable to      A PRV is a tradable     Predictability: Would
                    Vouchers (PRV).         biosecurity products.   certificate awarded     a priority-review
                                                                    to a developer of a     voucher simply
                                                                    treatment for a         accelerate a ``no''
                                                                    neglected tropical      or ``not yet''
                                                                    disease that gains      response?
                                                                    licensure from FDA.    2007 law: Text at:
                                                                    It entitles holder to   http://www.bvgh.org/
                                                                    a priority review (a    documents/HR3580-
                                                                    speedier review time)   CompromiseFDA-
                                                                    for a future product    PDUFABill.pdf Draft
                                                                    of their choosing,      FDA guidance: http://
                                                                    potentially             www.fda.gov/cber/
                                                                    shortening the review   gdlns/
                                                                    process by 6 to 12      tropicaldisease.htm.
                                                                    months.
                                                                   First PRV awarded to
                                                                    Novartis for Coartem
                                                                    malaria treatment
                                                                    (artemether and
                                                                    lumefantrine) in Apr
                                                                    09.
----------------------------------------------------------------------------------------------------------------
6................  Row 6; Column 1.......  Row 6; Column 2a......  Row 6; Column 3a......  Row 6; Column 4a.
                   Limited market size     Acquisition RFPs        Publication of          Requirements are not
                    (development costs >>   should state minimum    requirements along      static and can be
                    market potential).      quantities (total and   with advanced-          expected to change
                                            to each successful      development RFPs. It    based on threat
                                            awardee) to increase    may be possible to      assessments and
                                            market certainty to     more widely describe    discoveries during
                                            potential bidders and   procurement             product development.
                                            their investors.        requirements, in        Requirements may
                                                                    contrast to the more    signal USG threat
                                                                    sensitive value of      recognition, so may
                                                                    treatment               not be appropriate
                                                                    requirements.           for public release.
                                           Row 6; Column 2b......  Row 6; Column 3b......  Row 6; Column 4b.
                                           Contract terms          Treaty allies           Allies have not made
                                            allowing                represent additional    substantial
                                            manufacturers access    markets.                independent
                                            to allied foreign                               purchases to date.
                                            governments and other                           Some may hope/expect
                                            authorized customers                            USG to share
                                            outside the US, as                              stockpile when
                                            well as civilian                                attack occurs.
                                            first responders,
                                            hospitals, and travel-
                                            vaccine providers
                                            within the US.
                                           Row 6; Column 2c......                          Row 6; Column 4c.
                                           Add biodefense and                              Currently only drugs,
                                            other adult vaccines                            antidotes, and
                                            to Standardized                                 various treatments
                                            Equipment List (SEL)                            are covered, but not
                                            and Authorized                                  vaccines for
                                            Equipment List (AEL),                           prophylaxis in the
                                            so state and local                              first place.
                                            first-responders can
                                            use federal (DHS)
                                            grant funds to pay
                                            for vaccinations.
----------------------------------------------------------------------------------------------------------------
7................  Row 7; Column 1.......  Row 7; Column 2.......  Row 7; Column 3.......  Row 7; Column 4.

[[Page 40193]]

 
                   Surge issues..........  Compensation if         Define                  Potential
                                            commercial product(s)   ``compensation'' in     compensation may
                                            displaced during        initial contract or     need to include
                                            emergencies (e.g.,      agree to a dispute-     delay of a new
                                            lost sales, market      resolution mechanism.   product or loss of
                                            share, delayed                                  market share to a
                                            licensing).                                     competitor. Level
                                                                                            difficult to
                                                                                            determine a priori.
----------------------------------------------------------------------------------------------------------------
                                              Legislative Elements
----------------------------------------------------------------------------------------------------------------
8................  Row 8; Column 1.......  Row 8; Column 2a......  Row 8; Column 3a......  Row 8; Column 4a.
                   Predictability,         Increase annual NIAID   Multi-year contracting  Limited track record.
                    consistency adequacy    appropriation           authority (for large    Partial analogies:
                    of Congressional        increases for early-    molecules, due to      Aerospace industry in
                    appropriations.         stage MCM development   complex manufacturing   early 1940s.
                                            to offset flat          and limited use) and   Consistent
                                            funding since 2001      multi-year funding      procurement of
                                            anthrax attacks.        with carry-over         aircraft carriers
                                            Insufficient funds      authority for R&D and   since 1940s.
                                            now allocated for       procurement
                                            advanced development    initiatives.
                                            for CBRN.
                                           Increase BARDA          Manage funding as a     Congressional long-
                                            appropriations for      ``national              term recognition of
                                            advanced development    portfolio'' that        threat (natural and
                                            of CBRN MCMs and        mitigates risk by a     malicious) and
                                            continued long-term     broad set of target     tolerance for MCM
                                            funding for both CBRN   products, with          technical failure
                                            and pandemic            multiple MCMs per       unknown.
                                            countermeasues, to      disease.
                                            offset recent funding  Base metrics on
                                            shortfalls.             portfolio
                                                                    performance, rather
                                                                    than individual
                                                                    candidate
                                                                    countermeasures.
                                                                   Long-term funding and
                                                                    ongoing government
                                                                    procurement (10 years
                                                                    or longer) is
                                                                    essential to maintain
                                                                    warm-base MCM
                                                                    manufacturing and
                                                                    surge capacity.
                                           Row 8; Column 2b......  Row 8; Column 3b......
                                           Need significantly      Solution: a blend of
                                            expanded federal        indefinite mandatory
                                            funding under           funding authority
                                            BioShield for           with caveats to
                                            advanced development    assure good-faith
                                            and procurement         performance and
                                            activities (BioShield   sufficient ongoing
                                            reauthorization and     discretionary
                                            funding).               appropriations.
                                           Stop and reverse
                                            Congressional
                                            diversion of
                                            BioShield Reserve
                                            Fund for other
                                            initiatives ($412M in
                                            FY09 = $137M for
                                            pandemic + $275M for
                                            PAHPA
                                            implementation),
                                           Need long-term funding
                                            for acquisition of
                                            FDA-approved/licensed
                                            MCMs for Strategic
                                            National Stockpile.
----------------------------------------------------------------------------------------------------------------
9................  Row 9; Column 1.......  Row 9; Column 3.......  Row 9; Column 3.......  Row 9; Column 4.
                   Funding stream........  Provide for greater     PAHPA (2006)            Would likely require
                                            flexibility in          authorized $1B to       BARDA to use Other
                                            milestone-driven        BARDA for advanced      Transaction
                                            payment schedules       development of MCMs,    Authority (OTA) (not
                                            under PAHPA and         in addition to          used to date).
                                            BioShield, to account   BioShield Reserve
                                            for the                 Fund.
                                            unpredictability of    Avoids rPA102 scenario
                                            vaccine R&D technical   (risk of repayment
                                            difficulties and        upon cancellation).
                                            progress.
----------------------------------------------------------------------------------------------------------------
10...............  Row 10; Column 1......  Row 10; Column 2......  Row 10; Column 3......

[[Page 40194]]

 
                   Untrodden development   Cooperative R&D         Enhanced recognition
                    pathways.               Agreements (CRADAs)     that changes in
                                            allow collaboration     product requirements
                                            with respect for        can be expected to
                                            intellectual property.  increase the cost and
                                           US Gov't and sponsor     time required to
                                            agree on defined        achieve a useable
                                            development pathway     product.
                                            at early stages to     Requires enhanced
                                            achieve a target        integration of
                                            product profile.        efforts by each USG
                                                                    entity (notably
                                                                    BARDA, NIAID, CDC,
                                                                    FDA, DoD, InterAgency
                                                                    Board).
----------------------------------------------------------------------------------------------------------------
11...............  Row 11; Column 1......  Row 11; Column 2......  Row 11; Column 3......  Row 11; Column 4.
                   Facilitating            Streamline process to   Offer innovator an      Milestone payments
                    technology transfer     support integration     option of (a) a         could be used on a
                    from basic to           of disciplines needed   milestone payment       multiple of private
                    advanced development.   for successful scale-   (``prize'') as a        paid-in capital
                                            up of manufacturing     single fee to license   (variable) or a
                                            processes.              the intellectual        fixed amount per
                                           Increase U.S. Gov't      property for further    drug.
                                            funding for applied     development or (b)
                                            bioscience, material    continue involvement
                                            sciences and            in development in
                                            biopharmaceutical       exchange for the
                                            processes.              possibility of
                                                                    royalties after FDA
                                                                    licensure achieved.
----------------------------------------------------------------------------------------------------------------
                                             Human Capital Elements
----------------------------------------------------------------------------------------------------------------
12...............  Row 12; Column 1......  Row 12; Column 2......  Row 12; Column 3......  Row 12; Column 4
                   Human capital within    Grow the pool of        Increased range of      Additional
                    industry.               science and             scientific programs     flexibility needed
                                            engineering talent      offers additional       in USG agency
                                            pool within industry    career-development      authority to provide
                                            needed to develop and   for industrial          competitive
                                            manufacture MCMs        scientists and          compensation to
                                            within the US.          engineers.              critical employees.
                                                                   DARPA model assumes
                                                                    industry-standard
                                                                    compensation rates.
                                                                   Congress authorized
                                                                    large increases for
                                                                    NIH grants for
                                                                    researcher awards,
                                                                    but a long-term
                                                                    approach is needed to
                                                                    sustain the
                                                                    industrial base..
----------------------------------------------------------------------------------------------------------------
13...............  Row 13; Column 1......  Row 13; Column 2a.....  Row 13; Column 3a.....
                   Complex, evolving       Clarify expectations    Spill-over benefits to
                    regulatory              early in product        commercial sphere via
                    requirements.           development and         enhanced dialog with
                                            minimize changes in     FDA.
                                            expectations in
                                            application review
                                            (e.g., requirements
                                            under ``animal
                                            rule'').
                                           Row 13; Column 2b.....  Row 13; Column 3b.....  Row 13; Column 4b.
                                           Implement best          Partner with            Companies with
                                            practices for quality/  experienced biopharma   extensive FDA
                                            regulatory systems      organization to gain    experience not
                                            for biosecurity         access to either        currently engaged
                                            products.               staff or quality        with MCM development
                                                                    systems.                or manufacture.
                                           Row 13; Column 2c.....  Row 13; Column 3c.....
                                           Collaboration with FDA  Centralized advanced
                                            to meet evolving        development and
                                            (more stringent)        manufacturing to
                                            standards for           facilitate cross-
                                            development,            product learning and
                                            manufacture, clinical   system development.
                                            trials, and ``animal-
                                            rule'' pathways.
                                           Row 13; Column 2d.....
                                           Accelerated FDA review
----------------------------------------------------------------------------------------------------------------
14...............  Row 14; Column 1......  Row 14; Column 2......  Row 14; Column 3......  Row 14; Column 4
                   Administrative          Contracting reform to   Waive nonessential      Familiarity with
                    requirements to         relieve the             accounting              Federal Acquisition
                    comply with USG         regulatory and          requirements and        Regulations (FAR)
                    contracts.              reporting burden.       other components of     (or relief from
                                                                    the Federal             them).
                                                                    Acquisition
                                                                    Regulation (FAR).

[[Page 40195]]

 
                                                                   BARDA should identify
                                                                    opportunities to use
                                                                    Other Transaction
                                                                    Authority (OTA) to
                                                                    enhance R&D contracts
                                                                    (akin to DARPA)..
                                                                   Explore Cooperative
                                                                    R&D Agreement (CRADA)
                                                                    approaches.
----------------------------------------------------------------------------------------------------------------
15...............  Row 15; Column 1......  Row 15; Column 2......  Row 15; Column 3......
                   Adequacy of review and  Increase                More medical reviewers
                    consultation            appropriations to       needed, plus research
                    resources at FDA.       enhance FDA review      and assay development
                                            and consultation.       within FDA.
                                                                   Increase percentage of
                                                                    personnel eligible
                                                                    for enhanced bonus
                                                                    payments or super-
                                                                    grades.
----------------------------------------------------------------------------------------------------------------
                                                Societal Elements
----------------------------------------------------------------------------------------------------------------
16...............  Row 16; Column 1......  Row 16; Column 2......  Row 16; Column 3......  Row 16; Column 4
                   Contribution to         Exploration of          Enhanced corporate      Increased public
                    national security..     biosecurity MCMs is     reputation..            attention during
                                            likely to have spill-                           crisis.
                                            over benefits to
                                            ``natural''
                                            infectious diseases
                                            as well.
----------------------------------------------------------------------------------------------------------------
                                                 Legal Elements
----------------------------------------------------------------------------------------------------------------
17...............  Row 17; Column 1......  Row 17; Column 2......  Row 17; Column 3......  Row 17; Column 4.
                   Product liability.....  Expand coverage of      Indemnification via     Not tested in
                                            PREP Act to             Public Readiness &      practice or
                                            additional MCMs for     Emergency               litigated. http://
                                            which Material Threat   Preparedness (PREP)     www.pandemicflu.gov/
                                            Assessments (MTAs)      Act of 2005 (PL 109-    plan/federal/prep--
                                            exist.                  148, Dec 30, 2005).     act.html Public Law
                                                                                            109-148. PHS Act
                                                                                            Section 319(f)(3).
                                                                                            42 U.S.C. 247d-6d.
                                                                                           [See also Support
                                                                                            Antiterrorism by
                                                                                            Fostering Effective
                                                                                            Technologies (SAFE-
                                                                                            T) Act of 2002
                                                                                            [within Homeland
                                                                                            Security Act, Pub.
                                                                                            L. 107-296].]
----------------------------------------------------------------------------------------------------------------
18...............  Row 18; Column 1......  Row 18; Column 2......  Row 18; Column 3......
                   Antitrust Provisions..  Assess need for, plan,  Need ability to
                                            and implement           develop contingency
                                            antitrust waiver        plans and preliminary
                                            authority under PAHPA   communication and
                                            2006 for R&D and        technical
                                            preparedness            consultation.
                                            activities to allow    Continue and expand
                                            nominally competing     efforts such as those
                                            parties to              underway with
                                            collaborate during a    pandemic influenza
                                            public health           vaccine and adjuvant
                                            emergency or to         ``mix-and-match''
                                            conduct contingency     studies to assess
                                            exercises before a      safety and efficacy.
                                            public-health
                                            emergency. Involve
                                            DoJ and Attorney
                                            General in
                                            supervisory/
                                            compliance role.
----------------------------------------------------------------------------------------------------------------
                                               Corollary Elements
----------------------------------------------------------------------------------------------------------------
19...............  Row 19; Column 1......  Row 19; Column 2......  Row 19; Column 3......

[[Page 40196]]

 
                   Attractiveness of       Implement national      Consolidate Medicare
                    commercial vaccine      policies to provide     coverage of all
                    market for support of   adequate                vaccines within Part
                    future R&D and          reimbursement for       B (not Part D).
                    manufacturing.          vaccines and their
                                            administration in
                                            both the public and
                                            private sectors, to
                                            help underwrite and
                                            sustain the
                                            industrial base
                                            needed for
                                            biosecurity and
                                            global-health
                                            products.
                                                                   Increase
                                                                    administration
                                                                    reimbursement rates
                                                                    under Medicaid and
                                                                    Vaccines for Children
                                                                    (VFC) beneficiaries
                                                                    with federal
                                                                    subsidies to offset
                                                                    increased State costs.
                                                                   Third-party payers to
                                                                    provide first-dollar
                                                                    coverage for FDA-
                                                                    licensed vaccines and
                                                                    their administration
                                                                    under healthcare
                                                                    reform.
----------------------------------------------------------------------------------------------------------------
20...............  Row 20; Column 1......  Row 20; Column 2......  Row 20; Column 3......
                   Approaches suitable     Advanced Market         Examples: Guarantee a
                    for developing-world    Commitments (AMC)       market in developing
                    situations (perhaps     separately for          countries for
                    useful by analogy).     existing vaccines and   pneumococcal vaccines
                                            global health           to prevent deadly
                                            vaccines at R&D stage.  respiratory
                                                                    infections in
                                                                    children and as an
                                                                    incentive for
                                                                    development of
                                                                    vaccines that
                                                                    currently do not
                                                                    exist against
                                                                    infectious disease
                                                                    threats in those
                                                                    countries, but which
                                                                    may be imported into
                                                                    the U.S. or threaten
                                                                    global security.
----------------------------------------------------------------------------------------------------------------
                            Other Benefits to Involvement With Biosecurity Initiative
----------------------------------------------------------------------------------------------------------------
21...............  Row 21; Column 1......  Row 21; Column 2......  Row 21; Column 3......
                   Competitive situation.  Don't put all eggs in   Participation by
                                            one basket, allow       manufacturer with
                                            multiple technologies   U.S. Gov't withholds
                                            and product             scientific,
                                            candidates to           financial, and human-
                                            progress                capital benefit to
                                            simultaneously          competitors.
                                            through development
                                            pathways.
----------------------------------------------------------------------------------------------------------------
22...............  Row 22; Column 1......                          Row 22; Column 3......  Row 22; Column 4.
                   New intellectual                                IP developed in course  U.S. Gov't has step-
                    property.                                       of government           in rights if patent
                                                                    contract remains with   arising from federal
                                                                    discoverer.             government-funded
                                                                                            research not
                                                                                            exploited [Bayh-Dole
                                                                                            Act of 1980 (or
                                                                                            University & Small
                                                                                            Business Patent
                                                                                            Procedures Act),
                                                                                            codified in 35
                                                                                            U.S.C. 200-212[1],
                                                                                            implemented by 37
                                                                                            CFR 401[2]].
----------------------------------------------------------------------------------------------------------------
23...............  Row 23; Column 1......                          Row 23; Column 3......  Row 23; Column 4.
                   Staying abreast of                              Access to state-of-art  Need to understand
                    advancing sciences.                             process analytics for   exclusivity of
                                                                    wide variety of         access.
                                                                    biological products.
----------------------------------------------------------------------------------------------------------------

    Citations:
    Project BioShield Act of 2004: Public Law 108-276, http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_cong_public_laws&docid=f:publ276.108.pdf.
    BioShield II (2005):
    PAHPA, PL 109-417, Dec 19, 2006.
    Bibliography:
    Matheny J, Mair M, Mulcahy A, Smith BT. Incentives for 
biodefense countermeasure

[[Page 40197]]

development. Biosecur Bioterror 2007 Sep;5(3):228-38.
    Animal Rule = U.S. Food and Drug Administration. New drug and 
biological drug products; evidence needed to demonstrate 
effectiveness of new drugs when human efficacy studies are not 
ethical or feasible. Final rule. FR 2002 May 31;67(105):37988-98. 
http://frwebgate5.access.gpo.gov/cgi-bin/PDFgate.cgi?WAISdocID=483712496781+5+2+0&WAISaction=retrieve.
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[FR Doc. E9-19199 Filed 8-10-09; 8:45 am]
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