The National Biodefense Science Board (NBSB), a Federal Advisory Committee to the Secretary; Request for Public Comment, 40189-40199 [E9-19199]
Download as PDF
<![CDATA[
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
following changes are made to Form
323: The instructions have been revised
to incorporate a definition of ‘‘eligible
entity,’’ which will apply to the
Commission’s existing Equity Debt Plus
(‘‘EDP’’) standard, one of the standards
used to determine whether interests are
attributable. The instructions have also
been revised to update citations to the
Commission’s media ownership rules.
In addition, on April 8, 2009, the
Commission adopted a Report and
Order and Fourth Further Notice of
Proposed Rulemaking (the ‘‘323 Order’’)
in MB Docket Nos. 07–294, 06–121, 02–
277, 01–235, 01–317, 00–244, 04–228;
FCC 09–33. Consistent with actions
taken by the Commission in the 323
Order, the following changes are made
to Form 323: The instructions have been
revised to state the Commission’s
revised Biennial filing requirements
adopted in the 323 Order. The
instructions and questions in all
sections of the form have been
significantly revised. Many questions on
the form have been reworked or
reordered in order to (1) Clarify the
information sought in the form; (2)
simplify completion of the form by
giving respondents menu-style or
checkbox-style options to select rather
than submit a separate narrative exhibit;
and (3) make the data collected on the
form more adaptable for use in database
programs used to prepare economic and
policy studies relating to media
ownership.
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. E9–19222 Filed 8–10–09; 8:45 am]
of the Board of Governors. Comments
must be received not later than August
26, 2009.
A. Federal Reserve Bank of Atlanta
(Steve Foley, Vice President) 1000
Peachtree Street, N.E., Atlanta, Georgia
30309:
1. Don Arthur Barnette, Jonesboro,
Georiga; to acquire additional voting
shares of CCB Financial Corporation,
and thereby indirectly acquire
additional voting shares of Community
Capital Bank, both of Jonesboro,
Georgia.
2. Odric Gregory, individually, and as
Chief Manager of Gregory Investments
LLC, both of Gallatin, Tennessee; to
acquire additional voting shares of
Macon Banctrust, Inc., and thereby
indirectly acquire additional voting
shares of Macon Bank and Trust
Company, both of Lafayette, Tennessee.
B. Federal Reserve Bank of Dallas (E.
Ann Worthy, Vice President) 2200
North Pearl Street, Dallas, Texas 75201–
2272:
1. Harold Ira Kane, Corpus Christi,
Texas; to retain voting shares of Charter
Bancshares, Inc., and thereby indirectly
retain voting shares of Charter Alliance
Bank (de novo), both of Corpus Christi,
Texas, Charter IBHC, Inc., Wilmington,
Delaware, and Charter Bank, Corpus
Christi, Texas.
Board of Governors of the Federal Reserve
System, August 6, 2009.
Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. E9–19172 Filed 8–10–09; 8:45 am]
BILLING CODE 6210–01–S
FEDERAL MARITIME COMMISSION
BILLING CODE 6712–01–P
Notice of Agreements Filed; Correction
FEDERAL RESERVE SYSTEM
sroberts on DSKD5P82C1PROD with NOTICES
Change in Bank Control Notices;
Acquisition of Shares of Bank or Bank
Holding Companies
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire a bank or bank
holding company. The factors that are
considered in acting on the notices are
set forth in paragraph 7 of the Act (12
U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the office of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
Federal Maritime Commission.
Citation of Previous Notice of
Agreements Filed: 74 FR 37709, July 29,
2009.
Previous Notice of Agreements Filed
Dated: July 24, 2009.
Correction to the Notice of
Agreements Filed: All of the Filing
Parties and the complete Synopsis of
Agreement No. 201204 were not printed
in the original Notice. The complete
Notice should read as follows:
Agreement No.: 201204.
Title: Port of Houston Authority and
Houston Marine Terminal Operators/
Freight Handlers Agreement.
Parties: Port of Houston Authority;
Ceres Gulf, Inc.; Chaparral Stevedoring
Company of Texas, Inc.; CT
Stevedoring, Inc. dba Cooper/T. Smith
Stevedoring Co.; Ports America Texas,
Inc.; GP Terminals LLC; Shippers
AGENCY:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
40189
Stevedoring Company; and SSA Gulf,
Inc.
Filing Party: Erik A. Eriksson, Esq.;
Port of Houston Authority; Executive
Office; 111 East Loop; Houston, TX
77029–4327.
Synopsis: The agreement authorizes
the Port of Houston Authority and seven
affiliated freight handlers to discuss and
voluntarily agree on matters of common
interest at the Port of Houston.
Contact Person for More Information:
Karen V. Gregory, Secretary, (202) 523–
5725.
Tanga S. FitzGibbon,
Assistant Secretary.
[FR Doc. E9–19208 Filed 8–10–09; 8:45 am]
BILLING CODE 6730–01–P
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 (NBSB@hhs.gov) in
order to be considered by the Working
Group in preparing the final document.
E:\FR\FM\11AUN1.SGM
11AUN1
40190
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
ADDRESSES:
Availability of Materials: Requests for
a copy of the Inventory and
accompanying ‘‘Comment Revision
Form’’ should be made to the NBSB’s email box at NBSB@hhs.gov 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 NBSB@hhs.gov, 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 https://
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,
donald.malinowski@hhs.gov.
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.
sroberts on DSKD5P82C1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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 NBSB@hhs.gov
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 NBSB@hhs.gov 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:
0 Contracting with some portions of
the USG can be slow, unwieldy,
expensive, and opaque.
0 Lack of clarity increases industry
risk.
0 Procurement size, warm-base
requirements, length of review, etc.
0 Lack of transparency increases
industry risk.
0 Contract review process, rate of
issuance of new proposals, requirement
generation.
0 With a contract in place, situation
improves.
0 HHS viewed as cooperative,
helpful, responsible and responsive.
0 Perceived lack of coordination
between development activities and
regulatory responsibilities remains a
concern to industry.
Regulatory:
0 Lack of clarity regarding usable
product definitions, seeming differences
in FDA approaches to providing
guidance to industry.
0 Industry reliance upon USG for key
components of licensure submissions
can lead to lack of accountability.
0 Disease studies, toxicology reports,
etc.
Funding, Stability, Reliability,
Predictability:
0 Advanced Development needs
more dedicated funding, separate from
BioShield funding.
0 BioShield remains a funded
procurement device, not an advanceddevelopment mechanism.
E:\FR\FM\11AUN1.SGM
11AUN1
40191
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
0 Advanced development efforts
would benefit from contracting
flexibility.
0 Cost-plus-fee contracting flexibility
is appropriate for advanced
development and would reduce risk.
0 Multiyear funding.
0 Drug development and corporate
investment/planning is long-term
process, multiyear funding with carryover authority, with multi-year
contracting authority would signal USG
commitment and increase industry
sense of long-term stability.
0 Project BioShield expires in 2013
and will need to be reauthorized and
funded.
0 Five years not a long time in drugdevelopment process.
0 BioShield funds should not be
diverted to fund other initiatives.
0 Inadequate funding delays the
journey to MCM licensure.
0 Initiate additional program against
emerging diseases, modeled after
pandemic program.
Next Steps for WG :
0 Continue to identify obstacles to
greater industry participation in MCM
development.
0 Make recommendations where
appropriate.
0 Identify incentives to encourage
greater industry participation in MCM
development.
0 Make recommendations where
appropriate.
0 Consider alternative models for
MCM development.
0 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 developingworld 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
Problem/category
Potential solution
Approach/
advantages/
action
Problem/limitation
Column #1
Row #
Column #2
Column #3
Column #4
Financial Elements
1 ..........
Row 1; Column 1 ......................
Capital requirements to establish safety, efficacy, validated
manufacture.
Row 1; Column 2 ......................
Increase financial return after
risking capital to industrystandard rates.
Reduce requirement for private
capital for advanced development.
Row 1; Column 3 ......................
Increased federal funding for
advanced development, in
the form of cost-reimbursement contracts and rewarding private-capital investments with milestone payments and at procurement.
Row 1; Column 4.
Risk of distraction of large industry partners from commercial mission or dilution of
effort [potential conflict with
fiduciary responsibility to
shareholders of publicly traded companies].
2 ..........
Row 2; Column 1 ......................
Risk of technical failure of vaccine development effort.
Row 2; Column 2a ....................
Decentralized discovery/centralized development and manufacture.
Row 2; Column 3a ....................
Reimbursement of development
costs at cost +15%, with return-on-working-capital
at
22%, and cost-of-money-forcapital at 15%.
Row 2; Column 3b.
Provides support early in process.
Row 2; Column 4.
Lack of interest, given opportunity costs Congressional
tolerance for anticipatable
frustrations is unknown.
Row 2; Column 2b ....................
Evaluation of whether indirectcost reimbursement greater
than 100% may be appropriate.
Assistance with calculating indirect cost rates (for companies that have never done so
before)..
sroberts on DSKD5P82C1PROD with NOTICES
3 ..........
4 ..........
Row 3; Column 1 ......................
Tax incentives ...........................
Row 4; Column 1 ......................
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
Row 3; Column 2a ....................
Enhance current incremental
R&D tax credit (increase,
make refundable).
Row 3; Column 2b ....................
New investment tax credit
(20%) for construction of new
R&D and manufacturing facilities for biosecurity and
emerging-infectious disease
purposes (with refundable
and/or transferable provisions).
Row 3; Column 3a.
Currently, 20% for qualified
R&D expenses and 50% for
clinical-trial expenses.
Row 3; Column 3b ....................
Enhance net revenue ...............
Row 3; Column 4.
Not yet authorized.
Row 4; Column 2 ......................
Row 4; Column 3 ......................
Row 4; Column 4.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
E:\FR\FM\11AUN1.SGM
11AUN1
40192
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
INVENTORY OF ISSUES CONSTRAINING OR ENABLING INDUSTRIAL INVOLVEMENT WITH MEDICAL COUNTERMEASURE
DEVELOPMENT 18 MAY 09—Continued
Problem/category
Potential solution
Approach/
advantages/
action
Problem/limitation
Column #1
Column #2
Column #3
Column #4
Revenue enhancements based
on Intellectual Property.
Enhance current product or use
patent-term restoration and/
or extension (revise formula).
Allow full patent-term extension
for licensed products that
gain CBRN or emerging disease application (akin to adding pediatric indication).
Allow transfer of patent-term
extension to another product
or company (‘‘wildcard’’).
Market exclusivity: Increase
term of market exclusivity to
∼ 12–15 years and extend it
to biologicals (as does Orphan Drug Act).
Current statutory formula: Patent extension supplemented
by [1⁄2 time from IND to filing
BLA + full time from BLA filing to FDA approval/licensure].
Currently, 5 years of market exclusivity is provided to New
Chemical Entities (NCEs) but
not biologicals via HatchWaxman Act and 7 years of
market exclusivity is provided
via Orphan Drug Act.
Note: Orphan drug tax credit
applies to vaccines only if
less than 200,000 vaccinated
recipients anticipated.
5 ..........
Row 5; Column 1 ......................
Priority-Review
Vouchers
(PRV).
Row 5; Column 2 ......................
Make applicable to biosecurity
products.
Row 5; Column 3 ......................
A PRV is a tradable certificate
awarded to a developer of a
treatment for a neglected
tropical disease that gains licensure from FDA. It entitles
holder to a priority review (a
speedier review time) for a
future product of their choosing, potentially shortening the
review process by 6 to 12
months.
First PRV awarded to Novartis
for Coartem malaria treatment
(artemether
and
lumefantrine) in Apr 09.
Row 5; Column 4.
Predictability: Would a priorityreview voucher simply accelerate a ‘‘no’’ or ‘‘not yet’’ response?
2007 law: Text at: https://
www.bvgh.org/documents/
HR3580-CompromiseFDAPDUFABill.pdf Draft FDA
guidance: https://www.fda.gov/
cber/gdlns/
tropicaldisease.htm.
6 ..........
Row 6; Column 1 ......................
Limited market size (development costs >> market potential).
Row 6; Column 2a ....................
Acquisition RFPs should state
minimum quantities (total and
to each successful awardee)
to increase market certainty
to potential bidders and their
investors.
Row 6; Column 3a ....................
Publication of requirements
along with advanced-development RFPs. It may be possible to more widely describe
procurement requirements, in
contrast to the more sensitive
value of treatment requirements.
Row 6; Column 2b ....................
Contract terms allowing manufacturers access to allied foreign governments and other
authorized customers outside
the US, as well as civilian
first responders, hospitals,
and travel-vaccine providers
within the US.
Row 6; Column 2c ....................
Add biodefense and other adult
vaccines to Standardized
Equipment List (SEL) and
Authorized Equipment List
(AEL), so state and local
first-responders can use federal (DHS) grant funds to pay
for vaccinations.
Row 6; Column 3b ....................
Treaty allies represent additional markets.
Row 6; Column 4a.
Requirements are not static
and can be expected to
change based on threat assessments and discoveries
during product development.
Requirements may signal
USG threat recognition, so
may not be appropriate for
public release.
Row 6; Column 4b.
Allies have not made substantial independent purchases to
date. Some may hope/expect
USG to share stockpile when
attack occurs.
Row 7; Column 2 ......................
Row 7; Column 3 ......................
sroberts on DSKD5P82C1PROD with NOTICES
Row #
7 ..........
Row 7; Column 1 ......................
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
PO 00000
Frm 00038
Fmt 4703
Row 6; Column 4c.
Currently only drugs, antidotes,
and various treatments are
covered, but not vaccines for
prophylaxis in the first place.
Sfmt 4703
E:\FR\FM\11AUN1.SGM
11AUN1
Row 7; Column 4.
40193
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
INVENTORY OF ISSUES CONSTRAINING OR ENABLING INDUSTRIAL INVOLVEMENT WITH MEDICAL COUNTERMEASURE
DEVELOPMENT 18 MAY 09—Continued
Problem/category
Potential solution
Approach/
advantages/
action
Problem/limitation
Column #1
Column #2
Column #3
Column #4
Surge issues .............................
Compensation if commercial
product(s) displaced during
emergencies (e.g., lost sales,
market share, delayed licensing).
Define ‘‘compensation’’ in initial
contract or agree to a dispute-resolution mechanism.
Potential compensation may
need to include delay of a
new product or loss of market share to a competitor.
Level difficult to determine a
priori.
Row #
Legislative Elements
8 ..........
Row 8; Column 1 ......................
Predictability, consistency adequacy of Congressional appropriations.
Row 8; Column 2a ....................
Increase annual NIAID appropriation increases for earlystage MCM development to
offset flat funding since 2001
anthrax attacks. Insufficient
funds now allocated for advanced
development
for
CBRN.
Increase BARDA appropriations
for advanced development of
CBRN MCMs and continued
long-term funding for both
CBRN
and
pandemic
countermeasues, to offset recent funding shortfalls.
Row 8; Column 2b ....................
Need significantly expanded
federal funding under BioShield for advanced development and procurement activities (BioShield reauthorization and funding).
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.
Row 8; Column 3a ....................
Multi-year contracting authority
(for large molecules, due to
complex manufacturing and
limited use) and multi-year
funding with carry-over authority for R&D and procurement initiatives.
Row 8; Column 4a.
Limited track record. Partial
analogies:
Aerospace industry in early
1940s.
Consistent procurement of aircraft carriers since 1940s.
Manage funding as a ‘‘national
portfolio’’ that mitigates risk
by a broad set of target products, with multiple MCMs per
disease.
Base metrics on 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 3b.
Solution: a blend of indefinite
mandatory funding authority
with caveats to assure goodfaith performance and sufficient ongoing discretionary
appropriations.
Congressional long-term recognition of threat (natural and
malicious) and tolerance for
MCM technical failure unknown.
sroberts on DSKD5P82C1PROD with NOTICES
9 ..........
Row 9; Column 1 ......................
Funding stream .........................
Row 9; Column 3 ......................
Provide for greater flexibility in
milestone-driven
payment
schedules under PAHPA and
BioShield, to account for the
unpredictability of vaccine
R&D technical difficulties and
progress.
Row 9; Column 3 ...................... Row 9; Column 4.
PAHPA (2006) authorized $1B Would likely require BARDA to
to BARDA for advanced deuse Other Transaction Auvelopment of MCMs, in addithority (OTA) (not used to
tion to BioShield Reserve
date).
Fund.
Avoids rPA102 scenario (risk of
repayment upon cancellation).
10 ........
Row 10; Column 1 ....................
Row 10; Column 2 ....................
Row 10; Column 3..
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
E:\FR\FM\11AUN1.SGM
11AUN1
40194
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
INVENTORY OF ISSUES CONSTRAINING OR ENABLING INDUSTRIAL INVOLVEMENT WITH MEDICAL COUNTERMEASURE
DEVELOPMENT 18 MAY 09—Continued
Problem/category
Potential solution
Approach/
advantages/
action
Problem/limitation
Column #1
Column #2
Column #3
Column #4
Untrodden development pathways.
Cooperative R&D Agreements
(CRADAs) allow collaboration
with respect for intellectual
property.
US Gov’t and sponsor agree on
defined development pathway at early stages to
achieve a target product profile.
Enhanced
recognition
that
changes in product requirements can be expected to increase the cost and time required to achieve a useable
product.
Requires enhanced integration
of efforts by each USG entity
(notably
BARDA,
NIAID,
CDC, FDA, DoD, InterAgency Board).
Row 11; Column 1 ....................
Facilitating technology transfer
from basic to advanced development.
Row 11; Column 2 ....................
Streamline process to support
integration
of
disciplines
needed for successful scaleup of manufacturing processes.
Increase U.S. Gov’t funding for
applied bioscience, material
sciences and biopharmaceutical processes.
Row 11; Column 3 ....................
Offer innovator an option of (a)
a
milestone
payment
(‘‘prize’’) as a single fee to license the intellectual property for further development
or (b) continue involvement
in development in exchange
for the possibility of royalties
after FDA licensure achieved.
Row #
11 ........
Row 11; Column 4.
Milestone payments could be
used on a multiple of private
paid-in capital (variable) or a
fixed amount per drug.
Human Capital Elements
Row 12; Column 1 ....................
Human capital within industry ..
Row 12; Column 2 ....................
Grow the pool of science and
engineering talent pool within
industry needed to develop
and manufacture MCMs within the US.
Row 12; Column 3 ....................
Increased range of scientific
programs offers additional
career-development for industrial scientists and engineers.
DARPA model assumes industry-standard
compensation
rates.
Congress authorized large increases for NIH grants for researcher awards, but a longterm approach is needed to
sustain the industrial base..
13 ........
sroberts on DSKD5P82C1PROD with NOTICES
12 ........
Row 13; Column 1 ....................
Complex, evolving regulatory
requirements.
Row 13; Column 2a ..................
Clarify expectations early in
product development and
minimize changes in expectations in application review
(e.g., requirements under
‘‘animal rule’’).
Row 13; Column 2b ..................
Implement best practices for
quality/regulatory systems for
biosecurity products.
Row 13; Column 3a.
Spill-over benefits to commercial sphere via enhanced dialog with FDA.
Row 13; Column 2c ..................
Collaboration with FDA to meet
evolving (more stringent)
standards for development,
manufacture, clinical trials,
and ‘‘animal-rule’’ pathways.
Row 13; Column 2d.
Accelerated FDA review.
14 ........
Row 14; Column 1 ....................
Administrative requirements to
comply with USG contracts.
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
Row 14; Column 2 ....................
Contracting reform to relieve
the regulatory and reporting
burden.
PO 00000
Frm 00040
Fmt 4703
Row 12; Column 4
Additional flexibility needed in
USG agency authority to provide competitive compensation to critical employees.
Row 13; Column 3b ..................
Partner
with
experienced
biopharma organization to
gain access to either staff or
quality systems.
Row 13; Column 3c.
Centralized advanced development and manufacturing to
facilitate cross-product learning and system development.
Row 13; Column 4b.
Companies with extensive FDA
experience not currently engaged with MCM development or manufacture.
Row 14; Column 3 ....................
Waive nonessential accounting
requirements and other components of the Federal Acquisition Regulation (FAR).
Row 14; Column 4
Familiarity with Federal Acquisition Regulations (FAR) (or
relief from them).
Sfmt 4703
E:\FR\FM\11AUN1.SGM
11AUN1
40195
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
INVENTORY OF ISSUES CONSTRAINING OR ENABLING INDUSTRIAL INVOLVEMENT WITH MEDICAL COUNTERMEASURE
DEVELOPMENT 18 MAY 09—Continued
Problem/category
Potential solution
Approach/
advantages/
action
Problem/limitation
Column #1
Row #
Column #2
Column #3
Column #4
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 ....................
Adequacy of review and consultation resources at FDA.
Row 15; Column 2 ....................
Increase appropriations to enhance FDA review and consultation.
Row 15; Column 3.
More medical reviewers needed, plus research and assay
development within FDA.
Increase percentage of personnel eligible for enhanced
bonus payments or supergrades.
Societal Elements
16 ........
Row 16; Column 1 ....................
Contribution to national security..
Row 16; Column 2 ....................
Exploration
of
biosecurity
MCMs is likely to have spillover benefits to ‘‘natural’’ infectious diseases as well.
Row 16; Column 3 ....................
Enhanced corporate reputation.
Row 16; Column 4
Increased public attention during crisis.
Legal Elements
Row 17; Column 1 ....................
Product liability .........................
Row 17; Column 2 ....................
Expand coverage of PREP Act
to additional MCMs for which
Material Threat Assessments
(MTAs) exist.
Row 17; Column 3 ....................
Indemnification
via
Public
Readiness & Emergency
Preparedness (PREP) Act of
2005 (PL 109–148, Dec 30,
2005).
18 ........
sroberts on DSKD5P82C1PROD with NOTICES
17 ........
Row 18; Column 1 ....................
Antitrust Provisions ...................
Row 18; Column 2 ....................
Assess need for, plan, and implement antitrust waiver authority under PAHPA 2006
for R&D and preparedness
activities to allow nominally
competing parties to collaborate during a public health
emergency or to conduct
contingency exercises before
a public-health emergency.
Involve DoJ and Attorney
General in supervisory/compliance role.
Row 18; Column 3.
Need ability to develop contingency plans and preliminary
communication and technical
consultation.
Continue and expand efforts
such as those underway with
pandemic influenza vaccine
and
adjuvant
‘‘mix-andmatch’’ studies to assess
safety and efficacy.
Corollary Elements
19 ........
Row 19; Column 1 ....................
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
Row 19; Column 2 ....................
PO 00000
Frm 00041
Fmt 4703
Row 19; Column 3.
Sfmt 4703
E:\FR\FM\11AUN1.SGM
11AUN1
Row 17; Column 4.
Not tested in practice or litigated. https://www.
pandemicflu.gov/plan/federal/
prep_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].]
40196
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
INVENTORY OF ISSUES CONSTRAINING OR ENABLING INDUSTRIAL INVOLVEMENT WITH MEDICAL COUNTERMEASURE
DEVELOPMENT 18 MAY 09—Continued
Problem/category
Potential solution
Approach/
advantages/
action
Problem/limitation
Column #1
Column #2
Column #3
Column #4
Attractiveness of commercial
vaccine market for support of
future R&D and manufacturing.
Implement national policies to
provide adequate reimbursement for vaccines and their
administration in both the
public and private sectors, to
help underwrite and sustain
the industrial base needed
for biosecurity and globalhealth products.
Consolidate Medicare coverage
of all vaccines within Part B
(not Part D).
Row #
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 FDAlicensed vaccines and their
administration
under
healthcare reform.
20 ........
Row 20; Column 1 ....................
Approaches suitable for developing-world situations (perhaps useful by analogy).
Row 20; Column 2 ....................
Advanced
Market
Commitments (AMC) separately for
existing vaccines and global
health vaccines at R&D
stage.
Row 20; Column 3..
Examples: Guarantee a market
in developing countries for
pneumococcal vaccines to
prevent deadly 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
Row 21; Column 1 ....................
Competitive situation ................
22 ........
Row 22; Column 1 ....................
New intellectual property ..........
Row 22; Column 3 ....................
IP developed in course of government contract remains
with discoverer.
Row 22; Column 4.
U.S. Gov’t has step-in rights if
patent arising from federal
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 ........
sroberts on DSKD5P82C1PROD with NOTICES
21 ........
Row 21; Column 2 ....................
Don’t put all eggs in one basket, allow multiple technologies and product candidates to progress simultaneously through development
pathways.
Row 23; Column 1 ....................
Staying abreast of advancing
sciences.
Row 23; Column 3 ....................
Access to state-of-art process
analytics for wide variety of
biological products.
Row 23; Column 4.
Need to understand exclusivity
of access.
Citations:
Project BioShield Act of 2004: Public Law
108–276, https://frwebgate.access.gpo.gov/cgi-
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
Row 21; Column 3.
Participation by manufacturer
with U.S. Gov’t withholds scientific, financial, and humancapital benefit to competitors.
bin/getdoc.cgi?dbname=108_cong_public_
laws&docid=f:publ276.108.pdf.
BioShield II (2005):
PAHPA, PL 109–417, Dec 19, 2006.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Bibliography:
Matheny J, Mair M, Mulcahy A, Smith BT.
Incentives for biodefense countermeasure
E:\FR\FM\11AUN1.SGM
11AUN1
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
sroberts on DSKD5P82C1PROD with NOTICES
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
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
demonstrate effectiveness of new drugs when
human efficacy studies are not ethical or
feasible. Final rule. FR 2002 May
31;67(105):37988–98. https://frwebgate5.
access.gpo.gov/cgi-bin/PDFgate.cgi?
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
WAISdocID=483712496781+5+2+0&
WAISaction=retrieve.
BILLING CODE 4150–37–C
E:\FR\FM\11AUN1.SGM
11AUN1
40197
VerDate Nov<24>2008
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
20:51 Aug 10, 2009
Jkt 217001
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
E:\FR\FM\11AUN1.SGM
11AUN1
EN11AU09.038</GPH>
sroberts on DSKD5P82C1PROD with NOTICES
40198
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
[FR Doc. E9–19199 Filed 8–10–09; 8:45 am]
BILLING CODE 4150–37–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission of OMB Review; Comment
Request; Investigator Registration and
Financial Disclosure for Investigational
Trials in Cancer Treatment (NCI)
SUMMARY: In compliance with the
requirement of section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute, (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collected below. This proposed
information collection was previously
published in the Federal Register on
June 10, 2009 (74 FR 27552), and
allowed 60 days for public comment.
One public comment was received
regarding pharmaceutical testing. The
submitter responded to the e-mail. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a valid OMB control number.
Proposed Collection: Title:
Investigator Registration and Financial
Disclosure for Investigational Trials in
Cancer Treatment (NCI). Type of
Information Collection Request: Existing
Collection in Use without an OMB
Number. Need and Use of Information
Collection: Food and Drug
Administration (FDA) regulations
require sponsors to obtain information
from the investigator before permitting
the investigator to begin participation in
investigational studies. The National
Cancer Institute, (NCI) as a sponsor of
investigational drug trials, has the
responsibility to assure the FDA that
investigators in its clinical trials
program are qualified by training and
experience as appropriate experts to
investigate the drug. In order to fulfill
these requirements, a standard
Statement of Investigator (FDA Form
1572 modified), Supplemental
Investigator Data Form, Financial
Disclosure Form and Curriculum vitae
(CV) are required. The NCI will accept
40199
the investigator’s CV in any format. All
investigators maintain a CV as part of
their academic and professional
practice. The data obtained from these
forms allows the NCI to evaluate the
qualifications of the investigator,
identify appropriate personnel to
receive shipment of investigational
agent, ensure supplies are not diverted
for inappropriate protocol or patient use
and identify financial conflicts of
interest. Comparisons are done with the
intention of ensuring protocol, patient
safety and drug compliance for patient
and drug compliance for patient safety
and protections. Frequency of Response:
Annually.
Affected Public: Public sector,
businesses or other for-profit that will
include Federal agencies or employees,
non-profit institutions and a very small
number of private practice physicians.
Type of Respondents: Investigators. The
annual reporting burden is limited to
those physicians who choose to
participate in NCI sponsored
investigational trials to identify new
medicinal agents to treat and relieve
those patients suffering from cancer.
The annualized respondents’ burden
for record keeping is estimated to
require 8,564 hours (see table below).
TABLE—ESTIMATES OF ANNUAL BURDEN
Type of
respondents
Form
Investigators and Designee ...
Statement of Investigator .....
17,128
1
Supplemental Investigator ....
17,128
1
Financial Disclosure .............
17,128
1
...............................................
17,128
........................
sroberts on DSKD5P82C1PROD with NOTICES
Totals ..............................
There are no capital costs, operating
costs, and maintenance cost.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information; including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
VerDate Nov<24>2008
21:15 Aug 10, 2009
Jkt 217001
Number of
respondents
Frequency of
response
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the
Attention: NIH Desk Officer, Office of
Management and Budget, at
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Charles
L. Hall, Jr., Chief, Pharmaceutical
Management Branch, Cancer Therapy
Evaluation Program, Division of the
Cancer Treatment and Diagnosis, and
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Average time
per response
Total hour
burden
0.25 .......................................
(15 minutes) ..........................
0.167 .....................................
(10 minutes) ..........................
0.083 .....................................
(5 minutes) ............................
4,282
...............................................
8,564
2,855
1,427
Centers, National Cancer Institute,
Executive Plaza North, Room 7148, 9000
Rockville Pike, Bethesda, MD 20892 or
call non-toll-free number 301–496–5725
or E-mail your request, including your
address, to: Hallch@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days following the
date of this publication.
Dated: August 5, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E9–19207 Filed 8–10–09; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\11AUN1.SGM
11AUN1
]]>Agencies
[Federal Register Volume 74, Number 153 (Tuesday, August 11, 2009)]
[Notices]
[Pages 40189-40199]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19199]
=======================================================================
-----------------------------------------------------------------------
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 (NBSB@hhs.gov) 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 NBSB@hhs.gov 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 NBSB@hhs.gov,
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
https://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, donald.malinowski@hhs.gov.
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 NBSB@hhs.gov 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
NBSB@hhs.gov 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 https://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: https://
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. https://
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, https://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.
https://frwebgate5.access.gpo.gov/cgi-bin/
PDFgate.cgi?WAISdocID=483712496781+5+2+0&WAISaction=retrieve.
BILLING CODE 4150-37-C
[[Page 40198]]
[GRAPHIC] [TIFF OMITTED] TN11AU09.038
[[Page 40199]]
[FR Doc. E9-19199 Filed 8-10-09; 8:45 am]
BILLING CODE 4150-37-C
