[Federal Register Volume 75, Number 74 (Monday, April 19, 2010)]
[Notices]
[Pages 20326-20334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8954]
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DEPARTMENT OF COMMERCE
National Institute of Standards and Technology
[Docket No. 100407180-0181-01]
Technology Innovation Program (TIP) Notice of Availability of
Funds and Announcement of Public Meetings (Proposers' Conferences)
AGENCY: National Institute of Standards and Technology (NIST),
Department of Commerce.
ACTION: Notice.
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SUMMARY: The National Institute of Standards and Technology's (NIST)
Technology Innovation Program (TIP) announces that it will hold a
single fiscal year 2010 competition and is soliciting high-risk, high-
reward research and development (R&D) proposals for financial
assistance. TIP also announces that it will hold three public meetings
(Proposers' Conferences) for all interested parties. TIP is soliciting
proposals under this fiscal year 2010 competition in the area of
critical national need entitled ``Manufacturing'' as described in the
Program Description section below.
DATES: The due date for submission of proposals is 11:59 p.m. Eastern
Time, Thursday, July 15, 2010. This deadline applies to any mode of
proposal submission, including paper and electronic. Do not wait until
the last minute to submit a proposal. TIP will not make any allowances
for late submissions, including incomplete Grants.gov registration or
delays by guaranteed overnight couriers. To avoid any potential
processing backlogs due to last minute registrations, proposers are
strongly encouraged to start their Grants.gov registration process at
least four weeks prior to the proposal submission due date. Review,
selection, and award processing is expected to be completed by the end
of November 2010.
ADDRESSES: Proposals must be submitted to TIP as follows:
Paper submission: Send to National Institute of Standards and
Technology, Technology Innovation Program, 100 Bureau Drive, Stop 4750,
Gaithersburg, MD 20899-4750. Please note that the NIST site is closed
to the general public, and applicant personnel and couriers will not be
permitted onto the NIST site in order to deliver proposals. Also note
that the NIST Visitors Center is not permitted to accept proposals on
behalf of the Technology Innovation Program. Paper submissions will be
accepted from the U.S. Mail or similar commercial carrier that
routinely delivers mail to NIST.
Electronic submission: http://www.grants.gov.
FOR FURTHER INFORMATION CONTACT: Thomas Wiggins at 301-975-5416 or by
e-mail at [email protected].
SUPPLEMENTARY INFORMATION:
Additional Information: The full Federal Funding Opportunity (FFO)
announcement for this request for proposals contains detailed
information and requirements for the program. Proposers are strongly
encouraged to read the FFO in developing proposals. The full FFO
announcement text is available at http://www.grants.gov and on the TIP
Web site at http://www.nist.gov/tip/helpful-resources.cfm. In addition,
proposers are directed to review the April 2010 Technology Innovation
Program Proposal Preparation Kit available at http://www.nist.gov/tip/helpful-resources.cfm. The TIP Proposal Preparation Kit must be used to
prepare a TIP proposal. The TIP implementing regulations are published
at 15 CFR Part 296, and included in the TIP Proposal Preparation Kit as
Appendix B.
Public Meetings (Proposers' Conferences): TIP will hold three
public meetings (Proposers' Conferences) to provide general information
regarding TIP, to offer guidance on preparing proposals, and to answer
questions. Proprietary technical discussions about specific project
ideas with NIST staff are not permitted at these conferences or at any
time before submitting the proposal to TIP. Therefore, proposers should
not expect to have proprietary issues addressed at the Proposers'
Conferences. Also, NIST/TIP staff will not critique or provide feedback
on project ideas while they are being developed by a proposer. However,
NIST/TIP staff will answer questions about the TIP eligibility and
cost-sharing requirements, evaluation and award criteria, selection
process, and the general characteristics of a competitive TIP proposal
at the Proposers' Conferences and by phone and e-mail. Attendance at
the TIP Proposers' Conferences is not required.
The TIP Proposers' Conferences will be held on the following dates,
times, and at the following locations:
(1) April 28, 2010, 9 a.m.-2 p.m. Eastern Time: NIST Red
Auditorium, 100 Bureau Drive, Gaithersburg, MD. Pre-registration is
required by 5 p.m. Eastern Time on April 23, 2010, for the Proposers'
Conference being held at NIST Gaithersburg, MD. Due to increased
security at NIST, NO on-site registrations will be accepted and all
attendees MUST be pre-registered.
[[Page 20327]]
Photo identification must be presented at the NIST main gate to be
admitted to the April 28, 2010 conference. Attendees must wear their
conference badge at all times while on the NIST campus. Electronic
Registration at: http://www.nist.gov/public_affairs/confpage/100428.htm.
No registration fee will be charged for attending the Proposers'
Conferences. Presentation materials from the Gaithersburg, MD
Proposers' Conference will be made available on the TIP Web site.
The Gaithersburg, MD Proposers' Conference will webcast details at
the TIP Web site: http://www.nist.gov/tip.
(2) May 4, 2010, 1 p.m.-5 p.m. Pacific Time, Embassy Suites Hotel
Los Angeles International Airport--South, 1440 Imperial Avenue, El
Segundo, CA 90245.
(3) May 6, 2010, 9:00 a.m.-1 p.m. Eastern Time, Detroit Marriott
Renaissance Center, Renaissance Drive N, Detroit, MI 48243.
No Pre-registration is required for the Proposers' Conferences in
Los Angeles, CA or Detroit, MI.
Statutory Authority: Section 3012 of the America Creating
Opportunities to Meaningfully Promote Excellence in Technology,
Education, and Science (COMPETES) Act, Pub. L. 110-69 (August 9,
2007), codified at 15 U.S.C. 278n.
CFDA: 11.616, Technology Innovation Program.
Program Description: TIP is soliciting proposals under this fiscal
year 2010 competition in the area of critical national need entitled
``Manufacturing'' as described below.
Area of Critical National Need: Manufacturing
The goal of the research outcome/impacts from this competition is
to provide manufacturers and end users improved access to adequate
quantities of materials based on new advances at competitive costs that
allow evaluation and utilization of these materials in innovative ways,
and new manufacturing processes that can transform the way products are
made. TIP's funding strategy for this competition will emphasize three
important elements: (1) Process scale-up, integration and design for
materials advances; (2) Predictive modeling for materials advances and
materials processing; and (3) Critical process advances related to the
manufacturability of materials and manufacturing of both new and
existing products. These three elements of the societal challenge of
accelerating the use of materials advances and advances in critical
processes will be addressed as outlined in the white paper
Manufacturing and Biomanufacturing: Materials Advances and Critical
Processes (http://www.nist.gov/tip/cur_comp/index.cfm).
Materials performance is often a critical consideration and
controlling factor in the innovation process. High strength alloys are
used to build stronger, lighter and safer vehicles; superalloys are
used to make higher efficiency gas turbines; composites make larger,
more efficient wind turbine blades and provide improved performance in
aerospace applications; and nanomaterials are finding their way into
better performing batteries, energy storage devices, electronic inks,
high voltage transmission lines, and health care related applications
(e.g., imaging and therapeutics). Ceramics have new uses in improving
electronic and photonic devices, and glasses have many next-generation
applications such as wireless communication, displays, optical
telecommunication, integrated circuits, and ion exchange membranes for
fuel cells. Overcoming scale-up issues of moving novel materials
advances from the laboratory into manufacturing through ``faster,
better, cheaper'' methods is just one way to help manufacturers be more
successful and competitive. Critical processes are generally
manufacturing processes that have the greatest impact on one or more of
the following characteristics: product quality, product yields from raw
materials, scrap rates, efficiency of raw material consumption, and/or
other measures of efficiency. Many critical manufacturing processes are
not flexible enough to easily incorporate novel materials advances into
new products and many critical processes limit the nation's capacity to
supply existing strategically important products. Finding technical
solutions to these challenges in manufacturing can give the comparative
advantages necessary for retaining manufacturing in the United States.
Outlined in this announcement are three key areas related to the
manufacturability of materials advances and enhanced processing
capabilities and descriptions of the supporting technical challenges
that need to be addressed. If successful, the manufacturing solutions
envisioned will have the potential to:
Create significant improvements in new and existing products and
in their manufacture by accelerating the utilization of materials
advances and overcoming critical manufacturing process bottlenecks
to improve the competitiveness of U.S. manufacturers in the global
marketplace.
``Materials advances'' are defined for purposes of this funding
opportunity as:
Materials that have been developed to the point that unique
functionalities have been identified and these materials now need to
be made available in quantities large enough for innovators and
manufacturers to test and validate in order to develop new products.
The unique functionality that these materials represent will
require new levels of understanding in the sciences of materials
processing and process control. Nanomaterials, for example, will
require manipulation and measurement at the atomic level. In alloys,
the measurements and control would be at the microscale (and eventually
at the nanoscale) with an emphasis on anisotropic features of the micro
(nano) structure. With composites, ceramics, and glasses, measurements
and control would be at the mesoscale and would take advantage of the
anisotropic layering of the process. Control of one material or phase
within another will also be an important consideration.
A ``critical process'' is defined for purposes of this funding
opportunity as:
A process that has a significant impact on capacity, output,
quality, variability, efficiencies, performance, flexibility, etc.,
as well as a manufacturer's competitiveness and success.
Process improvements made through high-risk, high-reward research
and development, rather than simple engineering improvements or
redesign, could lead to significant and quantifiable improvements in
process output measures. As an example from last year's news headlines,
consider the vaccine production response to the H1N1 flu outbreak.
Experts were able to decode the virus to prepare a vaccine in record
time, but encountered problems supplying the large volumes of vaccine
needed in a timely fashion. Vaccines are grown in chicken eggs in a
process that dates back to World War II. Each egg is in effect its own
factory with product variability and purity issues. Development of new
processes for production of recombinant vaccines as well as processes
for real time monitoring and analysis could address these problems and
would help to not only respond rapidly to new virus outbreaks, but
could also reduce the cost of clinical trials through better scale-up
methodologies. Addressing these challenges and needs could also impact
other industries such as chemicals, biofuels, etc.
[[Page 20328]]
Element 1--Process Scale-Up, Integration, and Design for Materials
Advances
New materials typically are developed in a laboratory setting, and
then samples are given to end-users for alpha and beta testing. During
this testing phase, it can take considerable time and experimentation
to understand how the materials can be incorporated into a new product
in a way that maintains and utilizes their unique functionality.
Scaling-up from laboratory quantities to larger volumes, validating
properties, and then incorporating the materials into product
manufacturing lines is often non-linear and does not follow
straightforward scaling laws, due to the unique functionality that has
been obtained from the materials advances.
Element 2--Predictive Modeling Tools for Materials Advances and
Materials Processing
Predictive modeling capabilities are key to developing new
processes, scaling-up these processes, and understanding how to utilize
the unique functionality of materials advances. Modeling capabilities
are needed principally to:
a. Analyze and understand why newly discovered materials do what
they do and then extrapolate their behavior to new uses; and
b. Incorporate this knowledge more efficiently into process design
tools so new products can be made while maintaining the unique
functionality of the materials as predicted.
Element 3--Critical Process Advances
As the availability of new materials increases and the modeling of
their behavior becomes more refined, there is a complementary need to
improve processing or manufacturing methods. High-risk, high-reward
approaches are needed to exploit the properties of the materials
advances into new and more advanced products as well as support the
processing of existing materials in new and different ways, resolving
key bottlenecks or critical problems such as energy consumption,
processing time, scrap rates, quality, and throughput. Current methods
of manufacturing often are not rapidly adaptable to making new or
different products, and are often not optimized towards making existing
products faster, more cheaply, and more sustainably. Improving
processes used in the manufacture of new and existing products is an
imperative for the continued global competitiveness of U.S.
manufacturers. Agile, flexible, and increasingly interoperable systems
are necessary enhancements to base manufacturing technologies in order
to meet new productivity challenges.
Significant biomanufacturing process improvements are needed to
enhance safety, quality, and consistency of biopharmaceuticals while
reducing the manufacturing cost. For example, current sensing
technologies typically require manual sampling, are not rapid or robust
to cleaning agents or processes, and are not sufficiently reliable for
imbedding in the manufacturing environment as automated technology.
Critical process advances are needed, enabling rapid on-line sensing
and analytical capabilities. New tools are needed for bioprocess
optimization, control and improvement to enable a cost-effective batch
or continuous manufacturing process. Processes that involve integrated
sensing and detection capabilities for measuring multiple parameters
will be useful. Moreover, purification and separation process advances
involving novel membranes and affinity reagents are needed for cost-
effective downstream processing in biopharmaceutical manufacturing
processes.
The first two proposed elements for Manufacturing and
Biomanufacturing: Materials Advances and Critical Processes require
research in new technologies. The table below can be used to illustrate
possible relationships between key challenges. TIP would expect
solutions to the first two elements to map into one or more cells in
Table 1 below. It is possible that the areas below could also impact or
involve health care applications and/or biomanufacturing approaches.
Table 1
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Superalloys, alloys &
Technological needs Nanomaterials smart materials Composites Ceramics Glasses
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Processing of Materials:
Scale-up from Laboratory
Quantities/Controls.
Incorporate into New Uses/
Maintain Functionality.
Predictive Modeling:
Rules/Understand Why It Does
What It Does.
Process Modeling/Design Tools..
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For the first element, process scale-up, integration, and design
for materials advances, new processes will need to be developed. These
processes will increase to commercial scale the quantity and quality of
available advanced materials; or help incorporate these materials into
new, revolutionary products based on a new material's properties. These
scaled-up processes may be a next generation or an entirely new
process. For example, forging ever-larger parts cannot be solved by
building ever-larger forges (which becomes prohibitively expensive),
but instead by developing new techniques such as partial forging.
New instrumentation and measurement capabilities also will be
needed to support these new processes. These instruments will need to
measure real-time process parameters such as the properties that
provide the unique capabilities of the advanced materials (e.g.,
composition). In addition, instruments for real-time inspection are
needed to ensure and/or verify materials are being correctly
incorporated into manufactured products that require the revolutionary
functions of these new materials.
Proposals addressing process scale-up, integration, and design for
materials advances will be considered responsive if they include scale-
up of materials in one of the specified five materials classes (listed
in Table 1) that are derived from biological or other sources and
consist of one or more of the following:
A single process to achieve the goals of the scale-up, or
multiple processes integrated together into a coherent solution (i.e.,
diverse processes
[[Page 20329]]
or multiples of a single process for ``intensification'');
Scale-up of materials processes to manufacture and apply
coatings that are within the scope requirements for the material types
(nanomaterials; superalloys, alloys and smart materials; composites;
ceramics; and glasses, including bulk metallic glasses); or
Scale-up of materials processes for healthcare
applications (e.g., imaging, therapeutics, etc.).
Some examples of responsive proposals (not all-inclusive) include:
Nano structured silica from rice plant or algae.
Oxide nanoparticles produced by microorganisms.
Quantum dot-based nanocomposites produced by genetically
engineered viruses (e.g. M13 bacteriophage).
Cellulose/polyethylene oxide nanocomposites produced by
genetically engineered bacteria (Acetobacter Xylium).
Biologically produced silver carbon composites for
optically functional thin film.
Biologically produced natural fiber reinforced aerogel
composites.
Composites made with chitosan derived from crustacean
shells.
Proposals addressing process scale-up, integration and design for
materials advances must address all of the following issues:
Address one or more of the materials areas specified in
this announcement.
Quantify the baseline processing capabilities.
Describe how the results of the process scale-up could
lead to new products and manufacturing process capabilities.
Provide quantification and qualification of the estimated
output of the final project results.
Scale-up of the quantities produced during the project
must be targeted to increase by a factor of 1,000 fold or more (unit
quantity per unit time) as compared to the baseline.
A detailed scientific rationale and description of the
challenges to accomplish scale-up of the process(es) must be included.
Proposals addressing process scale-up, integration, and design of
materials advances will be considered more competitive if they:
Include validation methodologies by or with processors or
end users and/or
Address sustainability issues.
Proposals addressing process scale-up, integration, and design for
materials advances will be considered nonresponsive if they:
Have the primary focus of the proposal on materials that
are not included within Table 1 (i.e. pure polymers).
Focus primarily on the application of material coatings
using a material not included in Table 1.
Do not provide a quantitative technical discussion of
baseline capabilities (state-of-the-practice or state-of-the-art).
For the second element, predictive modeling for materials advances
and materials processing, new tools are needed to enable researchers to
use constitutive relations and rules (with validation) concerning the
underlying behavior of materials (understanding structure vs. function)
and the changes to behavior due to manufacturing processes. For
example, new tools will need to account for the scale-dependent
behavior of materials advances. This capability will enable a better
and quicker understanding of why materials do what they do. These
efforts will also enable extrapolation of that knowledge beyond the
laboratory conditions for which they were developed, and will therefore
need new validation and verification capabilities.
In addition, critical knowledge is needed about why certain
decisions or assumptions were made, in order to incorporate new
modeling capabilities for laboratory results into process design and
modeling. Again, new validation and verification methodologies will be
essential.
With successful development of these tools, processes, and
technologies, the manufacturing communities will have significantly
improved capabilities to quickly incorporate advanced materials
breakthroughs into revolutionary products based on new materials
functionality, and thus establish new competitive advantages in a
global economy.
Proposals addressing predictive modeling for materials advances and
materials processing must address all of the following issues:
Address one or more of the materials areas given in Table
1.
Quantify the baseline modeling capability.
Describe how the results of the proposed modeling
capabilities could lead to new products and manufacturing process
capabilities.
Proposals for predictive modeling for materials advances and
materials processing must also address one or both of the following:
Develop constitutive relationships and rules that describe
the behavior and the process of the materials at a level that is useful
for describing laboratory results, as well as for developing a greater
understanding of the materials for end users and/or
Develop or use the constitutive relationships and rules to
develop process design tools for the manufacturing processes for these
materials advances.
Proposals addressing predictive modeling for materials advances and
materials processing will be considered more competitive if they
address:
Collaboration by or with those who manufacture the
materials, in order to validate the models and/or
How users will specifically benefit from the acceleration
and implementation of the proposed models in support of materials
reliability (i.e. final properties or mechanical performance) and
materials behavior before and after processing.
Proposals addressing predictive modeling for materials advances and
materials processing that do not include validation of models will be
considered less competitive.
Proposals addressing predictive modeling for materials advances and
materials processing will be considered nonresponsive if they:
Have the primary focus of the proposal on materials that
are not included within Table 1 (i.e., pure polymers).
Focus primarily on the application of material coatings
using a material not included under Table 1.
Do not provide a quantitative technical discussion of
baseline capabilities (state-of-the-practice or state-of-the-art).
The third element, critical process advances, requires
modifications in manufacturing processes that augment and expand
current limited capabilities. Applications could include those oriented
towards the creation of novel methods to fabricate unique components
from complex, difficult-to-machine materials (advanced engineering
materials or smart materials), or the design and implementation of
real-time, sensor-based, feedback-optimized systems for discrete,
continuous or batch manufacturing processes. A discrete manufacturing
example could be a process for making customized parts such as medical
implants, using techniques such as additive manufacturing, near net-
shape fabrication, or partial forging. Processes are needed for the
manufacture of parts possessing complex geometries from existing and
novel materials while preserving the properties of the material. A
batch process example would be improved process monitoring
[[Page 20330]]
and in situ analytical tools, enabling a reduction in batch-to-batch
variability and an improvement in quality, and quantity of
biopharmaceuticals or other products produced in a more reliable and
cost-effective manner.
A table for guidance on categorizing applicable processes and
pathways to critical process advances is given below. TIP would expect
solutions to the third societal challenge to map into one or more of
the cells in Table 2 below.
Table 2
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Process
State-of-the-art approaches to critical manufacturing process -----------------------------------------------
advances for: Batch Discrete Continuous
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Improving quality............................................... .............. .............. ..............
Increasing throughput........................................... .............. .............. ..............
Reducing costs.................................................. .............. .............. ..............
Enhancing sustainability........................................ .............. .............. ..............
Enabling new capabilities....................................... .............. .............. ..............
Improving agility............................................... .............. .............. ..............
Other improvements.............................................. .............. .............. ..............
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Proposals addressing critical process advances will be considered
responsive if they address improvements in quality, throughput, costs,
sustainability, new capabilities, and agility, relative to the state-
of-the-art for the process being proposed.
In drafting a proposal addressing critical process advances
applicants should address topics in their area of interest such as:
If a proposal offers improvements in several of these
categories, the multiple improvements could be combined. For example, a
proposed new process might offer half the setup time and triple the
rate of production compared to existing processes.
Benefits are not necessarily ``linear''; for example, a
component of a machine might benefit from increased strength or
durability up to a point, beyond which there is little incremental
benefit.
Because manufacturing processes generally involve
tradeoffs, a proposed new process may involve improvements in some
areas and tradeoffs in other areas. For example, a proposed process
might offer a factor of six cost reduction but a production rate
decrease of a factor of two, and the net benefit of the tradeoff will
be evaluated.
Proposals should quantify to the extent possible every
aspect of the advance in state of the art (as shown by the rows in the
Table 2 above), including any that may offer decreased benefit as a
tradeoff to further increase the advance in another area. Claimed
benefits must be quantified for particular target application(s).
(Example: ``a new forging and heat treatment process for automobile
axles will allow 50% lighter parts to be used and cut manufacturing
cost by x%, improving fuel economy by y%, and ultimately reducing
greenhouse gas emissions by z million tons per year.'')
The evaluation process should not make assumptions about
performance parameters that are not discussed. For example, if a
proposal claims lower cost but does not mention quality, reviewers will
have to consider the possibility that quality is being sacrificed to
save on cost, and such a proposal will be less competitive than one
that offers comparable cost saving together with a claim for quality
equal to or better than current products.
The term ``biomanufacturing'' as used throughout this notice and in
the FFO announcement refers to manufacturing of biopharmaceuticals.
Biopharmaceuticals are complex pharmaceutical products manufactured by
biotechnology. Two types of biomanufacturing are considered:
bioprocessing for production of biopharmaceuticals such as recombinant
proteins as vaccines, therapeutics, or as molecular probes for
diagnostics, and advanced biofabrication and processing for production
of cell or tissue-based biopharmaceuticals such as engineered cells and
engineered tissues as therapies. Engineered tissues are complex
structures involving cells, scaffolds and signaling molecules.
Manufacturing of either type of biopharmaceuticals is within the scope
of the competition.
Proposals addressing critical process advances will be considered
responsive if they provide improvements in one or more critical
processes integrated together into a coherent solution to significantly
enhance process efficiencies and reduce process variability.
Some examples of responsive proposals (not all-inclusive) include:
New biomanufacturing process capabilities enabling rapid
on-line monitoring of production cell health and function (e.g. cell
viability, metabolism, contaminants) and on line monitoring of the
structure and function of engineered cells or tissues when developed as
therapeutics.
Advanced bioprocesses for rapid on-line analysis of
biopharmaceuticals (e.g. protein glycoforms, three-dimensional
structure, aggregates, immunogenicity and contaminating bacteria,
viruses, mycoplasma, production cell proteins and nucleic acids).
Advanced active control feedback systems for monitoring
and controlling complex bioprocesses and high throughput microreactor/
bioreactor array systems for optimizing production cell systems (e.g.
engineered Chinese Hamster Ovary or CHO cells, insect cells,
microorganisms, or algae).
Advances in critical processes in cost effective scale up
of engineered cells or engineered tissues.
New, automated processes for producing parts using
composite materials.
Affordable fabrication methods for lightweight components
manufactured from low cost titanium powders.
Reduction of energy intensity and demand, carbon dioxide
and greenhouse gas emissions in glassmaking or other high energy
consuming sectors.
Precision additive manufacturing of medical devices.
Low cost technologies for advancing the uses of
nanomaterials in a variety of end products.
Responsive proposals addressing critical process advances must
address all of the following issues:
Address how the improved manufacturing processes are
transformational compared to the state-of-the-art;
Describe how the results of the research will lead to new
and improved manufacturing processes enabling safe, cost effective and
reliable production and new and improved products such as customized
medical implants, large bearings, etc.;
[[Page 20331]]
Describe why the technological solutions are high-risk and
high-reward in nature; and
Provide quantification and qualification of the estimated
output of the final project results.
Proposals addressing critical process advances will be considered
more competitive if they:
Include multiple improvement areas from the table above;
Include validation methodologies by or with processors or
end users; and/or
Address sustainability issues.
Examples of proposals addressing critical process advances that
will be considered nonresponsive are:
Any manufacturing process that offers only incremental
improvement over existing processes;
Processes that are intended primarily for military/
weaponry applications (e.g. warhead manufacture, chemical/biological
warfare materials production);
Manufacturing processes that cannot be performed in the
U.S. due to existing laws or regulations;
Projects primarily focused on production of non engineered
cells or tissues as therapeutics;
Projects involving straightforward scale-up of
biopharmaceuticals with incremental improvements in the manufacturing
processes;
Projects that involve incremental improvements in
traditional processes for biomolecule production (e.g. vaccine
production in chicken eggs, hormones such as insulin extracted from pig
tissue);
Biomanufacturing projects that primarily focus on
processes for production of non-biopharmaceutical products (e.g.
production of biofuels or small molecule drugs);
Projects that primarily focus on drug discovery or design
of new biomaterials;
Projects that primarily focus on discovery of new
production cell systems;
Projects that use living genetically modified vertebrate
animals, invertebrate animals, or plants as bioreactors for
biopharmaceutical production;
Production or scale up of scaffolds or biomaterials used
in scaffold design that are not a part of the manufacturing of
engineered tissues; and
Projects with a primary focus (people, equipment, time,
and/or funds) on device development.
Additional Requirements for All Manufacturing Proposals
TIP proposals are strengthened and generally considered most
competitive when the proposed research plan includes validation by
others of the research goals. When preparing a proposal, it is
necessary to quantify and qualify the ability of the research results
to ``Transform the Nation's Capacity to Deal with Major Societal
Challenges''. The claims that any proposal makes relative to this key
criterion are strengthened by validation of the research results with
one or more end user(s) of the technology. The proposal may make
assertions by narrative and referenced third-party documentation. The
addition of ``letters of interest'' in the research results by
potential end users adds strength to a proposal. Ultimately, the
addition of one or more end users in a validation task implementing the
research results would present the strongest case for commitment to the
planned research goals.
Examples of validation tasks within each of the three elements
might include:
Process scale-up, integration, and design for advanced
materials: Create a prototype using the advanced material produced from
the research.
Predictive modeling for advanced materials and materials
processing: Apply modeling capability by implementing the new model
information as a key knowledge component into a process or product.
Critical process advances: Integrate the research results
into processes for optimization, control and improvements in
manufacturing and product analysis (e.g. composites, metals, chemicals,
biopharmaceuticals).
Nonresponsive projects under this area of critical national need
include:
Projects whose principal focus is on discovery of new
materials;
Efforts related to the physical extraction of raw
materials;
Straightforward improvements to existing processes or
materials without the potential for a transformational increase in
performance to the technical requirements;
Integration projects using only existing state-of-the-art
processes, models or materials;
Software development that is predominantly
straightforward, routine data gathering using applications of standard
software development practices; and
Projects that do not include a quantitative baseline and
quantitative metrics for tracking research.
In addition to the competition-specific nonresponsive projects, the
following are nonresponsive projects:
Straightforward improvements of existing products or
product development.
Projects that are Phase II, III, or IV clinical trials.
TIP will rarely fund Phase I clinical trials and reserves the right not
to fund a Phase I clinical trial. The portion of a Phase I trial that
may be funded must be critical to meeting evaluation criterion (a)(1)
addressing the scientific and technical merit of the proposal. The
trial results must be essential for completion of a critical R&D task
of the project. The definitions of all phases of clinical trials are
provided in the TIP Guidelines and Documentation Requirements for
Research Involving Human & Animal Subjects located at http://www.nist.gov/tip/helpful-resources.cfm.
Pre-commercial-scale demonstration projects where the
emphasis is on demonstrating that some technology works on a large
scale or is economically sound rather than on R&D that advances the
state of the art and is high-risk, high-reward.
Projects that TIP determines would likely be completed
without TIP funds in the same time frame or nearly the same time frame,
or with the same scale or scope.
Predominantly straightforward, routine data gathering
(e.g., creation of voluntary consensus standards, data gathering/
handbook/specification sheet preparation, testing of materials, or
unbounded research aimed at basic discovery science) or application of
standard engineering practices.
Projects in which the predominant risk is market
oriented--that is, the risk that the end product may not be embraced by
the marketplace.
Projects with software work, that are predominantly about
final product details and product development, and that have
significant testing involving users outside the research team to
determine if the software meets the original research objectives, are
likely to be either uncompetitive or possibly ineligible for funding.
However, R&D projects with limited software testing, involving users
outside of the research team, or vertebrate animals, may be eligible
for funding and contain eligible costs within a TIP award when the
testing is critical to meeting evaluation criteria and/or award
criteria and the testing results are essential for completion of a
critical task in the proposed research. This type of testing in
projects may also be considered to involve human subjects or vertebrate
animals in research and require compliance with applicable Federal
regulations and NIST policies for the
[[Page 20332]]
protection of human subjects or live vertebrate animals.
Unallowable/Ineligible Costs: The following items, regardless of
whether they are allowable under the Federal cost principles, are
ineligible/unallowable under TIP:
a. Bid and proposal costs unless they are incorporated into a
Federally-approved indirect cost rate (e.g., payments to any
organization or person retained to help prepare a proposal).
b. Construction costs for new buildings or extensive renovations of
existing buildings. However, costs for the construction of experimental
research and development facilities to be located within a new or
existing building are allowable provided the equipment or facilities
are essential for carrying out the proposed project and are approved in
advanced by the NIST Grants Officer. These types of facility costs may
need to be prorated if they will not be used exclusively for the
research activities proposed.
c. Contractor office supplies and contractor expenses for
conferences/workshops.
d. Contracts to another part of the same company or to another
company with identical or nearly identical ownership. Work proposed by
another part of the same company or by another company with identical
or nearly identical ownership should be shown as funded through inter-
organizational transfers that do not contain profit. Inter-
organizational transfers should be broken down in the appropriate
budget categories.
e. For research involving human and/or animal subjects, any costs
used to secure Institutional Review Board or Institutional Animal Care
and Use Committee approvals before or during the award.
f. General purpose office equipment and supplies that are not used
exclusively for the research: e.g., office computers, printers,
copiers, paper, pens, and toner cartridges.
g. Indirect costs, which must be absorbed by the recipient.
However, indirect costs are allowable for contractors under a single
company or joint venture. (Note that indirect costs absorbed by the
recipient may be used to meet the cost-sharing requirement.)
h. Marketing, sales, or commercialization costs, including
marketing surveys, commercialization studies, and general business
planning, unless they are included in a Federally approved indirect
cost rate.
i. Office furniture costs, unless they are included in a Federally
approved indirect cost rate.
j. Patent costs and legal fees, unless they are included in a
Federally approved indirect cost rate.
k. Preaward costs: i.e., any costs incurred prior to the award
start date.
l. Profit, management fees, interest on borrowed funds, or
facilities capital cost of money. However, profit is allowable for
contractors under a single company or joint venture.
m. Project development planning (e.g. patent and literature
searches) and creation of milestones. For example, proposals that plan
on developing milestones only if an award is received and after
literature searches are performed under the award are generally not
competitive. Costs for literature searches in general are ineligible.
n. Relocation costs, unless they are included in a Federally
approved indirect cost rate.
o. Salaries: NIST limits the salaries of project personnel to not
exceed Level I of the Executive Schedule ($199,700 as of January 2010
http://www.opm.gov/oca/10tables/html/ex.asp).
p. Tuition costs are generally not allowed as direct costs on
projects. An institution of higher education participating in a TIP
project as a contractor or as a joint venture member or lead may charge
TIP for tuition remission or other forms of compensation paid as, or in
lieu of, wages to students performing necessary work. These are
allowable, provided the requirements are met under 2 CFR Subtitle A,
Chapter 2, Part 220, Appendix A. 45 (formerly OMB Circular A-21,
Section J. 41). In such cases, tuition remission and other forms of
compensation paid to students shall be treated as direct costs in
accordance with the actual work being performed, and listed in the
budget under ``Other.'' Tuition remission may be charged on an average
rate basis.
Funding Availability: Fiscal year 2010 appropriations include funds
in the amount of approximately $25 million for new TIP awards. The
anticipated start date is January 1, 2010. The period of performance
depends on the R&D activity proposed. A single company can receive up
to a total of $3 million with a project period of performance of up to
3 years. A joint venture can receive up to total of $9 million with a
project period of performance of up to 5 years. Continuation funding
after the initial award is based on satisfactory performance,
availability of funds, continued relevance to program objectives, and
is at the sole discretion of NIST.
Eligibility: Single companies and joint ventures may apply for TIP
funding as provided in 15 CFR Sec. Sec. 296.2, 296.4, and 296.5.
Nonprofit organizations must meet the eligibility criteria set forth in
15 CFR 296.5(a)(2), which explains the eligibility criteria for
companies.
Large-sized Company Participation: A large-sized company is not
eligible to apply for TIP funding. A large-sized company is defined as
any business, including any parent company plus related subsidiaries,
having annual revenues in excess of $1.7208 billion. This number is
based on the May 2009 issue of Fortune magazine's Fortune 1000 list.
(Note that the revenue amount will be updated annually and will be
noted in future annual announcements of availability of funds.)
Cost-Sharing Requirements: Proposers must provide a cost share of
at least 50 percent of the yearly total project costs (direct plus all
of the indirect costs).
Evaluation and Award Criteria: Proposals are selected for funding
based on the evaluation criteria listed in 15 CFR 296.21 and the award
criteria listed in 15 CFR 296.22 as identified below. Additionally,
pursuant to 15 U.S.C. 278n(c), no proposal will be funded unless TIP
determines that it meets all of the award criteria listed in 15 CFR
296.22. Detailed guidance on how to address the evaluation and award
criteria is provided in Chapter 2 of the TIP Proposal Preparation Kit,
which is available at http://www.nist.gov/tip/helpful-resources.cfm.
Evaluation Criteria: The two components of the evaluation criteria
and respective weights as listed in 15 CFR 296.21 are as follows:
(a)(1) The proposer(s) adequately addresses the scientific and
technical merit and how the research may result in intellectual
property vesting in a United States entity including evidence that:
(i) The proposed research is novel;
(ii) The proposed research is high-risk, high-reward;
(iii) The proposer(s) demonstrates a high level of relevant
scientific/technical expertise for key personnel, including contractors
and/or informal collaborators, and has access to the necessary
resources, for example research facilities, equipment, materials, and
data, to conduct the research as proposed;
(iv) The research result(s) has the potential to address the
technical needs associated with a major societal challenge not
currently being addressed; and
(v) The proposed research plan is scientifically sound with tasks,
milestones, timeline, decision points and alternate strategies.
[[Page 20333]]
(2) Total weight of (a)(1)(i) through (v) is 50%.
(b)(1) The proposer(s) adequately establishes that the proposed
research has strong potential for advancing the state-of-the-art and
contributing significantly to the United States science and technology
knowledge base and to address areas of critical national need through
transforming the Nation's capacity to deal with a major societal
challenge(s) that is not currently being addressed, and generate
substantial benefits to the Nation that extend significantly beyond the
direct return to the proposer including an explanation in the proposal:
(i) Of the potential magnitude of transformational results upon the
Nation's capabilities in an area;
(ii) Of how and when the ensuing transformational results will be
useful to the Nation; and
(iii) Of the capacity and commitment of each award participant to
enable or advance the transformation to the proposed research results
(technology).
(2) Total weight of (b)(1)(i) through (iii) is 50%.
Award Criteria: The six components of the award criteria as listed
in 15 CFR 296.22 are as follows:
(a) The proposal explains why TIP support is necessary, including
evidence that the research will not be conducted within a reasonable
time period in the absence of financial assistance from TIP;
(b) The proposal demonstrates that reasonable and thorough efforts
have been made to secure funding from alternative funding sources and
no other alternative funding sources are reasonably available to
support the proposal;
(c) The proposal explains the novelty of the research (technology)
and demonstrates that other entities have not already developed,
commercialized, marketed, distributed, or sold similar research results
(technologies);
(d) The proposal has scientific and technical merit and may result
in intellectual property vesting in a United States entity that can
commercialize the technology in a timely manner;
(e) The proposal establishes that the research has strong potential
for advancing the state-of-the-art and contributing significantly to
the United States science and technology knowledge base; and
(f) The proposal establishes that the proposed transformational
research (technology) has strong potential to address areas of critical
national need through transforming the Nation's capacity to deal with
major societal challenges that are not currently being addressed, and
generate substantial benefits to the Nation that extend significantly
beyond the direct return to the proposer.
NIST must determine that a proposal successfully meets all six
award criteria for the proposal to receive funding under the Program.
Selection Factors: In making final selections, the Selecting
Official will select funding recipients based upon the Evaluation
Panel's rank order of the proposals and the following selection
factors:
a. Appropriate distribution of funds among technologies and their
applications,
b. Availability of funds, and/or
c. Program priorities.
Program Priorities: TIP is soliciting proposals under this fiscal
year 2010 competition in the area of critical national need entitled
``Manufacturing'' as described in the Program Description section
above.
Selection Procedures: Proposals are selected based on a multi-
disciplinary peer-review process, as described in 15 CFR 296.20. A
preliminary review is conducted to determine if the proposal is in
accordance with 15 CFR 296.3; complies with the eligibility
requirements described in 15 CFR 296.5; addresses award criteria (a)
through (c) of 15 CFR 296.22; was submitted to a previous TIP
competition, and if so, has been substantially revised; and is
complete. Proposals that are incomplete or do not meet any one of the
preliminary review requirements will normally be eliminated. All
remaining proposals are then carefully reviewed by an Evaluation Panel
consisting of Federal employees using the TIP evaluation criteria
listed in 15 CFR 296.21 and award criteria listed in 15 CFR 296.22. The
Evaluation Panel will present funding recommendations to the Selecting
Official in rank order for further consideration. The Selecting
Official makes the final selections for funding. The selection of
proposals by the Selecting Official is final and cannot be appealed.
The final approval of selected proposals and award of assistance will
be made by the NIST Grants Officer. The award decision of the NIST
Grants Officer is final and cannot be appealed.
NIST reserves the right to negotiate the cost and scope of the
proposed work with the proposers that have been selected to receive
awards. This may include requesting that the proposer delete from the
scope of work a particular task that is deemed by NIST to be
inappropriate for support. NIST also reserves the right to reject a
proposal where information exists that raises a reasonable doubt as to
the responsibility of the proposer.
Intellectual Property Requirements: For single company award
recipients, pursuant to the Bayh-Dole Act (35 U.S.C. 202(a) and (b))
and ``Memorandum to the Heads of Executive Departments and Agencies:
Government Patent Policy'' (February 18, 1983), the entity that invents
owns the invention. However, pursuant to 35 U.S.C. 202(a)(i), when a
single company or its contractor under a TIP award is not located in
the United States or does not have a place of business located in the
United States or is subject to the control of a foreign government,
NIST will require that title to inventions made by such parties be
transferred to a United States entity that will ensure the
commercialization of the technology in a timely fashion.
For joint ventures, ownership of inventions arising from a TIP-
funded project may vest in any participant in a joint venture, as
agreed by the members of the joint venture (notwithstanding 35 U.S.C.
202(a) and (b)). (Participant includes any entity that is identified as
a recipient, subrecipient, or contractor on an award to a joint
venture.)
Title to any such invention shall not be transferred or passed,
except to a participant in the joint venture, until the expiration of
the first patent obtained in connection with such invention.
Should the last existing participant in a joint venture cease to
exist prior to the expiration of the first patent obtained in
connection with any invention developed from assistance provided under
TIP, title to such patent must be transferred or passed to a U.S.
entity that can commercialize the technology in a timely fashion.
The United States reserves a nonexclusive, nontransferable,
irrevocable paid-up license, to practice or have practiced for or on
behalf of the United States any intellectual property developed from a
TIP award. The Federal government shall not in the exercise of such
license publicly disclose proprietary information related to the
license. This does not prohibit the licensing to any company of
intellectual property rights arising from a TIP-funded project. (15 CFR
296.11(b)(3)). The Federal government also has march-in rights in
accordance with 37 CFR 401.6. Intellectual property means an invention
patentable under title 35, United States Code, or any patent on such an
invention, or any work for which copyright protection is available
under title 17, United States Code. (15 CFR 296.2.)
Projects Involving Human Subjects. Research involving human
subjects
[[Page 20334]]
must be in compliance with applicable Federal regulations and NIST
policies for the protection of human subjects. Human subjects research
activities involve interactions with live human subjects or the use of
data, images, tissue, and/or cells/cell lines (including those used for
control purposes) from human subjects. Research involving human
subjects may include activities such as the use of image and/or audio
recording of people, taking surveys or using survey data, using
databases containing personal information, testing software with
volunteers, and many tasks beyond those within traditional biomedical
research. A Human Subjects Determination Checklist is included in the
April 2010 TIP Proposal Preparation Kit in Chapter 6 (http://www.nist.gov/tip/helpful-resources.cfm) to assist you in determining
whether your proposed research plan has human subjects involvement,
which would require additional information in your proposal submission,
and possibly more documentation during the Evaluation Panel's
consideration of your proposal. See the TIP Guidelines and
Documentation Requirements for Research Involving Human & Animal
Subjects for more specific information on documentation requirements
and due dates for documentation located at http://www.nist.gov/tip/helpful-resources.cfm or by calling 1-888-847-6478. President Obama has
issued Exec. Order No. 13,505, 74 FR 10667 (March 9, 2009), revoking
previous executive orders and Presidential statements regarding the use
of human embryonic stem cells in research. On July 30, 2009, President
Obama issued a memorandum directing that agencies that support and
conduct stem cell research adopt the ``National Institutes of Health
Guidelines for Human Stem Cell Research'' (NIH Guidelines), which
became effective on July 7, 2009, ``to the fullest extent practicable
in light of legal authorities and obligations.'' On September 21, 2009,
the Department of Commerce submitted to the Office of Management and
Budget a statement of compliance with the NIH Guidelines. In accordance
with the President's memorandum, the NIH Guidelines, and the Department
of Commerce statement of compliance, NIST will support and conduct
research using only human embryonic stem cell lines that have been
approved by NIH in accordance with the NIH Guidelines and will review
such research in accordance with the Common Rule and NIST implementing
procedures, as appropriate. NIST will not support or conduct any type
of research that the NIH Guidelines prohibit NIH from funding. NIST
will follow any additional polices or guidance issued by the current
Administration on this topic.
Projects Involving Live Vertebrate Animals. Research involving live
vertebrate animals must be in compliance with applicable Federal
regulations and NIST policies for the protection of live vertebrate
animals. Vertebrate animal research involves live animals that are
being cared for, euthanized, or used by the project participants to
accomplish research goals or for teaching or testing. The regulations
do not apply to animal tissues purchased from commercial processors or
tissue banks or to uses of preexisting images of animals (e.g., a
wildlife documentary or pictures of animals in newscasts). The
regulations do apply to any animals that are transported, cared for,
euthanized or used by a project participant for testing, research, or
training such as testing of new procedures or projects, collection of
biological samples or observation data on health and behavior. Detailed
information regarding the use of live vertebrate animals in research
plans and required documentation is available in the TIP Guidelines and
Documentation Requirements for Research Involving Human & Animal
Subjects located at http://www.nist.gov/tip/helpful-resources.cfm or by
calling 1-888-847-6478.
Executive Order 12372 (Intergovernmental Review of Federal
Programs): Proposals under this program are not subject to Executive
Order 12372.
Administrative Procedure Act and Regulatory Flexibility Act: Prior
notice and comment are not required under 5 U.S.C. 553, or any other
law, for rules relating to public property, loans, grants, benefits or
contracts (5 U.S.C. 553(a)). Because prior notice and an opportunity
for public comment are not required pursuant to 5 U.S.C. 553 or any
other law, the analytical requirements of the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.) are inapplicable. Therefore, a regulatory
flexibility analysis is not required and has not been prepared.
E.O. 13132 (Federalism): This notice does not contain policies with
Federalism implications as defined in Executive Order 13132.
E.O. 12866 (Regulatory Planning and Review): This notice is
determined to be not significant under Executive Order 12866.
Paperwork Reduction Act: Notwithstanding any other provision of the
law, no person is required to, nor shall any person be subject to
penalty for failure to, comply with a collection of information,
subject to the requirements of the Paperwork Reduction Act (PRA),
unless that collection of information displays a currently valid Office
of Management and Budget (OMB) Control Number. This notice contains
collection-of-information requirements subject to the PRA. The use of
Form NIST-1022, Standard Form-424 (R&R), SF-424B, SF-LLL, Research and
Related Other Project Information Form, and CD-346 has been approved by
OMB under the respective control numbers 0693-0050, 4040-0001, 4040-
0007, 0348-0046, 4040-0001, and 0605-0001.
Administrative and National Policy Requirements. DoC Pre-Award
Notification Requirements. The Department of Commerce Pre-Award
Notification Requirements for Grants and Cooperative Agreements are
contained in, 73 FR 7696 (February 11, 2008), apply to this notice. On
the form SF-424 R&R items 5. and 6., the applicant's 9-digit Employer/
Taxpayer Identification Number (EIN/TIN) and 9-digit Dun and Bradstreet
Data Universal Numbering System (DUNS) number must be consistent with
the information on the Central Contractor Registration (CCR) (http://www.ccr.gov) and Automated Standard Application for Payment System
(ASAP). For complex organizations with multiple EIN/TIN and DUNS
numbers, the EIN/TIN and DUNS number MUST be the numbers for the
applying organization. Organizations that provide incorrect/
inconsistent EIN/TIN and DUNS numbers may experience significant delays
in submitting their proposals through grants.gov and receiving funds if
their proposal is selected for funding.
Dated: April 13, 2010.
Marc G. Stanley,
Acting Deputy Director.
[FR Doc. 2010-8954 Filed 4-16-10; 8:45 am]
BILLING CODE 3510-13-P