and Human Services (HHS)
EXPIRED
SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY
TRANSFER (STTR) TO DEVELOP NEW THERAPIES FOR TYPE 1 DIABETES AND ITS
COMPLICATIONS
RELEASE DATE: August 28, 2003
RFA Number: RFA-DK-03-020 (This RFA has been reissued, see RFA-DK-05-015)
(This RFA has been modified, see RFA-DK-05-010)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov/)
National Eye Institute (NEI)
(http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR)
(http://www.ninr.nih.gov/)
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.847, 93.867, 98.837,
93.855, 93.853, 93.361, 93.865
LETTER OF INTENT RECEIPT DATE: January 19,2004
APPLICATION RECEIPT DATE: February 19, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Project Period and Amount of Award
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
NOTICE: This Request for Application (RFA) must be read in conjunction with
the current OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH,
CENTERS FOR DISEASE CONTROL AND PREVENTION, and FOOD AND DRUG ADMINISTRATION
FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY
TRANSFER (STTR) GRANT APPLICATIONS. The solicitation (see
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) contains
information about the SBIR and STTR programs, regulations governing the
programs, and instructional information for submission. All of the
instructions within the SBIR/STTR Omnibus Solicitation apply with the
following exceptions:
o This RFA is a one-time solicitation with the receipt date of 2/19/03.
o Upon receipt applications will be reviewed by a Special Emphasis Panel
organized by NIDDK.
PURPOSE OF THIS RFA
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),
National Eye Institute (NEI), National Heart, Lung, and Blood Institute
(NHLBI), National Institute of Allergy and Infectious Diseases (NIAID),
National Institute of Neurological Disorders and Stroke (NINDS), National
Institute of Nursing Research (NINR), National Institute of Child Health and
Human Development (NICHD) invite the small business community to apply
cutting edge technology to research to develop new approaches to prevent,
treat, and cure type 1 diabetes and its complications.
This RFA will utilize the Small Business Innovation Research (SBIR) and Small
Business Technology Transfer (STTR) mechanisms, but will be run in parallel
with other requests for applications (RFAs) of similar scientific scope
(DK-03-015 for Innovative Partners and DK-03-001 for Bench to Bedside) that will
utilize the traditional research project grant (R01), the
exploratory/developmental grant (R21) or the exploratory/developmental grant
phase II (R33) grant mechanisms.
RESEARCH BACKGROUND AND OBJECTIVES:
Type 1 diabetes is an autoimmune disease that destroys the insulin-producing
cells of the pancreas and affects an estimated one million Americans, usually
with onset in childhood or young adulthood. The disease markedly impairs
quality of life and shortens lifespan primarily through premature
cardiovascular mortality. Cardiovascular complications are increased four-
fold compared to the general population, and type 1 diabetes is associated
with numerous complications including blindness, renal failure, painful nerve
disorders, and amputation. In addition to its devastating toll in human
suffering, type 1 diabetes and its complications result in significant health
care expenditures for families and constitute a major societal economic
burden.
Recent research progress in understanding and treating this disease has been
dramatic. Researchers can now accurately identify individuals at increased
risk of type 1 diabetes based on genetic tests and antibody measurements.
Clinical trials are ongoing in those with new onset disease to test new
immunomodulatory agents that may have the potential to preserve residual
function of the insulin producing beta cells. Clinical trials have
demonstrated dramatic reductions in complications of type 1 diabetes through
intensive glycemic control. However, dangerous episodes of hypoglycemia
limit attempts to control blood glucose in many patients with type 1
diabetes. Recently researchers have reported success using islet
transplantation to restore lost beta cell function. However, the current
immunosuppressive regimens required for transplant survival have significant
immediate side effects and long term safety is uncertain. The small business
community in encouraged to contribute to the rapid progress toward developing
safe and effective cell based beta cell replacement therapy, as well other
new approaches to prevent, treat and cure type 1 diabetes and its macro- and
micro-vascular complications.
This RFA is intended to support innovative research in the field of type 1
diabetes and its complications, conducted by small business (SBIR) and small
business in partnership with academia (STTR). Examples of projects that this
announcement intends to solicit include:
o Development of novel therapeutics, including beta cell replacement therapy,
devices, biologics and other drugs for the treatment of type 1 diabetes and
its complications.
o Development of methods to increase the yield of functional and successfully
transplantable islets from pancreata including the development of alternative
enzymatic approaches to isolate islets and methods to increase the duration
for which a pancreas can be utilized.
o Development of methods to develop replenishible sources of islet like cells
or to expand the number of human islets during culture while still retaining
appropriate functional islet characteristics and the ability to be
successfully transplanted.
o Development of pre-transplant islet testing approaches that are predictive
of subsequent successful islet transplantation using functional genomics,
proteomics or other methods.
o Development of methods to improve viability/function of islets prior to
transplantation and the engraftment and long term function of islets after
transplantation including gene transfer, encapsulation or immunoisolation,
and the evaluation of alternative transplantation sites.
o Development of improved approaches to xenotransplantation as an unlimited
source of islets that would reduce potential complications and enhance graft
survival.
o Application of basic research in regenerative medicine to preclinical or
clinical treatment of type 1 diabetes and its complications.
o Application of gene therapy strategies to prevent or reverse complications.
o Development of novel approaches to immunomodulation or development of
tolerance with relevance to type 1 diabetes and/or of methods to measure
changes in immune status in type 1 diabetes, such as pathogenic T cell
assays.
o The development of methodology or biomarkers to help understand the
physiology or improve the diagnosis and treatment of type 1 diabetes and its
complications (e.g. novel genetic screening methodologies, application of
proteomic technologies).
o The development of methods for measuring or imaging the pancreatic beta
cell mass or inflammation.
o Development of methods for early detection, diagnosis and quantification of
cardiovascular disease, neuropathy, retinopathy and nephropathy in type 1
diabetes.
o Development of non-invasive or minimally invasive methods for continuous
monitoring of blood glucose and/or approaches to linkage of monitoring
devices to miniaturized insulin delivery systems for the development of a
"closed loop" artificial pancreas.
o Identification of biomarkers for use in clinical trials that could serve as
surrogate outcomes for monitoring the progression of type 1 diabetes and/or
its complications or for quantitatively assessing response to therapy to
prevent or reverse disease.
o Development of high throughput assays based on biologic pathways likely
involved in the pathogenesis of type 1 diabetes complications or autoimmunity
that could be used to screen molecular libraries for novel therapeutic
agents.
o The development of novel animal models for investigating type 1 diabetes
and its complications
MECHANISM(S) OF SUPPORT
This RFA uses the SBIR and STTR mechanisms, which are set-aside programs. As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project. Future unsolicited, competing- continuation
applications based on this project will compete with all SBIR/STTR
applications and will be reviewed according to the customary peer review
procedures. The anticipated award date is October 2004. Applications that are
not funded in the competition described in this RFA may be resubmitted as NEW
SBIR/STTR applications using the standard receipt dates for NEW applications
described in the current SBIR/STTR Omnibus Solicitation.
This RFA uses just-in-time concepts. It also uses the modular budgeting
format. Specifically, if you are submitting an application budget of $100,000
total costs (direct, F&A and fee) or less, use the modular format and
instructions as described in the current SBIR/STTR Omnibus Solicitation.
Otherwise follow the instructions for non-modular research grant
applications. This program does not require cost sharing as defined in the
current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
Except as otherwise stated in this RFA, awards will be administered under NIH
grants policy as stated in the NIH Grants Policy Statement, March 2001,
available at http://grants.nih.gov/grants/policy/nihgps_2001.
Applications may be submitted for support as Phase I STTR (R41) or Phase I
SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants; or the
SBIR/STTR FAST-TRACK option as described in the SBIR/STTR Omnibus
Solicitation. Phase II applications in response to this RFA will only be
accepted as competing continuations of previously funded NIH Phase I
SBIR/STTR awards. The Phase II application must be a logical extension of
the Phase I research but not necessarily a Phase I project supported in
response to this RFA. Fast Track applications will benefit from expedited
evaluation of progress following the Phase I feasibility study for transition
to Phase II funding for expanded developmental work.
PROJECT PERIOD AND AMOUNT OF AWARD
The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of
funding support and project duration periods for SBIR and STTR Phase I and
Phase II awards. For this RFA, budgets up to $500,000 total costs per year
and time periods up to 2 years for Phase I may be requested. Budgets up to $
1,000,000 total costs per year and up to 3 years may be requested for Phase
II. Total costs include direct costs, F&A, and fee/profit.
FUNDS AVAILABLE
The total funds available will be approximately $4,000,000 in FY2004.
The participating institutes intend to fund 6-10 phase I, Phase II or Fast
Track SBIR projects and 1-2 phase I, Phase II or Fast Track STTR projects.
Although the financial plans of the sponsoring Institutes provide support for
this program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
ELIGIBLE INSTITUTIONS:
Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation.
Only small business concerns are eligible to submit SBIR/STTR applications.
A small business concern is one that, on the date of award for both Phase I
and Phase II agreements, meets ALL of the criteria as described in the
current SBIR/STTR Omnibus Solicitation.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with his/her institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs. On an SBIR application, the principal
investigator must have his/her primary employment (more than 50%) with the
small business at the time of award and for the duration of the project. The
PI on an STTR application may be employed with the small business concern or
the participating non-profit research institution as long as s/he has a
formal appointment with or commitment to the applicant small business
concern, which is characterized by an official relationship between the small
business concern and that individual.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues.
o Direct questions about scientific/research issues to:
Dr. Sanford Garfield
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 685
Bethesda, MD 20892-5460
TEL:(301) 594-8803
Fax: (301) 480-6271
Email: [email protected]
Peter Dudley, Ph.D.
Division of Extramural Activities
National Eye Institute
6120 Executive Boulevard
Executive Plaza South, Suite 350
Bethesda, MD 20892-7164
TEL:(301) 451-2020
Fax: (301) 402-0528
Email: [email protected]
Cristina Rabadan-Diehl, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 10186
6701 Rockledge Drive
Bethesda, MD 20892-7956
Phone: (301) 435-0550
FAX: (301) 480-2858
E-mail: [email protected]
Dr. John Paul Ridge
Division of Allergy, Immunology and Transplantation Research
National Institute of Allergy and Infectious Disease
6610 Rockledge Drive, Room 3027
Bethesda, MD 20892
Phone: (301) 496-7104
FAX: (301) 480-1450
E-mail: [email protected]
Paul L. Nichols, Ph.D.
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2108
6001 Executive Blvd.
Bethesda, MD 20892
Phone: 301-496-9964
FAX: 301-401-2060
E-mail: [email protected]
Dr. Nell Armstrong
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710
Bethesda, MD 20892-4870
Telephone: (301) 594-5973
FAX: (301) 480-8260
Email: [email protected]
Dr. Gilman D. Grave
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard; Suite 4B-11
Bethesda, MD 20892-7510
Telephone: 301-496-5593
Fax: 301-480-9791
e-mail: [email protected]
o Direct questions about peer review issues to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]
o Direct questions about financial or grants management matters to:
Kathleen Shino
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 708
Bethesda, MD 20892-5452
Telephone: (301) 594-8869
FAX: (301) 480-3504
Email: [email protected]
William W. Darby
Grants Management
National Eye Institute
6120 Executive Boulevard
Executive Plaza South, Suite 350
Bethesda, MD 20892-7164
TEL:(301) 496-5884
Fax: (301) 496-9997
Email: [email protected]
Susan Lowenthal
Grants Management
National Heart, Lung, and Blood Institute
Rockledge II, Room 7155
6701 Rockledge Drive
Bethesda, MD 20892-7926
Phone: (301) 435-0159
FAX: (301) 480-3310
E-mail: [email protected]
John Paul Ridge
Grants Management
National Institute of Allergy and Infectious Disease
6610 Rockledge Drive, Room 3027
Bethesda, MD 20892
Phone: (301) 496 7104 phone
FAX: (301) 480 1450 fax
E-mail: [email protected]
Karen Shields
Grants Management Branch
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 3290
6001 Executive Blvd.
Bethesda, MD 20892
Phone: 301-496-9231
FAX: 301-402-0129
E-mail: [email protected]
Diane E. Drew
Grants Management
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710
Bethesda, MD 20892-4870
Telephone: (301) 594-2807
FAX: (301) 451-5651 or (301) 402-4502
Email: [email protected]
Dr. Gilman D. Grave
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard; Suite 4B-11
Bethesda, MD 20892-7510
Telephone: 301-496-5593
Fax: 301-480-9791
e-mail: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows IC staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]
SUBMITTING AN APPLICATION
The PHS 398 research grant application must be used for all SBIR/STTR Phase
I, Phase II and Fast-Track applications (new and revised.) Effective October
1, 2003, applicants must have a DUN and Bradstreet (D&B) Data Universal
Numbering System (DUNS) number as the Universal Identifier when applying for
Federal grants or cooperative agreements. The DUNS number can be obtained by
calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com. The DUNS number should be entered on line
11 of the face page of the PHS 398 form. The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html. Prepare your
application in accordance with the SBIR/STTR Omnibus Solicitation and the PHS
398. Helpful information for advice and preparation of the application can be
obtained at: http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The
NIH will return applications that are not submitted on the 5/2001 version of
the PHS 398. For further assistance contact GrantsInfo, Telephone: (301)
710-0267, Email: [email protected].
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: If you are submitting
an application budget of $100,000 total costs (direct, F&A and fee) or less,
you must use the modular format and instructions as described in the
SBIR/STTR Omnibus Solicitation.
USING THE RFA LABEL: The RFA label available in the PHS 398 application form
must be affixed to the bottom of the face page of the application. Type the
RFA number on the label. Failure to use this label could result in delayed
processing of the application such that it may not reach the review committee
in time for review. In addition, the RFA title and number must be typed on
line 2 of the face page of the application form and the YES box must be
marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.doc or
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
The title and number of this RFA must be typed on line 2 of the face page of
the application.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and three signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (for USPS EXPRESS or REGULAR MAIL)
Bethesda, MD 20817 (for EXPRESS/COURIER NON-USPS SERVICE)
At the time of submission, two additional copies of the application and
five sets of appendices must be sent to:
Francisco Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]
APPLICATION PROCESSING: Applications must be received on or before the
receipt date listed on the first page of this announcement. If an application
is received after that date, it will be returned to the applicant without
review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
The Center for Scientific Research (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. However, when a previously unfunded application, originally
submitted as an investigator-initiated application, is to be submitted in
response to an RFA, it is to be prepared as a NEW application. That is the
application for the RFA must not include an Introduction describing the
changes and improvements made, and the text must not be marked to indicate
the changes. While the investigator may still benefit from the previous
review, the RFA application is not to state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by NIDDK. Incomplete applications will not be reviewed. If
the application is not responsive to the RFA, NIH staff may contact the
applicant to determine whether to return the application to the applicant or
submit it for review in competition with unsolicited applications at the next
appropriate NIH review cycle.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NIDDK in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by an appropriate national advisory council
or board.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals within
the context of the SBIR/STTR Program:
o Significance
o Approach
o Innovation
o Investigator
o Environment
ALL SBIR/STTR APPLICATIONS
o Significance: Does the proposed project have commercial potential to lead
to a marketable product or process? Does this study address an important
problem? What may be the anticipated commercial and societal benefits of the
proposed activity? If the aims of the application are achieved, how will
scientific knowledge be advanced? Does the proposal lead to enabling
technologies (e.g., instrumentation, software) for further discoveries? Will
the technology have a competitive advantage over existing/alternate
technologies that can meet the market needs?
o Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Is the proposed plan a sound approach for establishing technical and
commercial feasibility? Does the applicant acknowledge potential problem
areas and consider alternative strategies? Are the milestones and evaluation
procedures appropriate?
o Innovation: Does the project challenge existing paradigms or employ novel
technologies, approaches or methodologies? Are the aims original and
innovative?
o Investigators: Is the Principal Investigator capable of coordinating and
managing the proposed SBIR/STTR? Is the work proposed appropriate to the
experience level of the Principal Investigator and other researchers,
including consultants and subcontractors (if any)? Are the relationships of
the key personnel to the small business and to other institutions appropriate
for the work proposed?
o Environment: Is there sufficient access to resources (e.g., equipment,
facilities)? Does the scientific and technological environment in which the
work will be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific environment
or employ useful collaborative arrangements?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
RELEVANCE TO THE GOALS OF THIS RFA: Does the proposed project have the
potential to open new avenues to the prevention, treatment and cure of type 1
diabetes and its complications? For Fast Track applications, are there clear
milestones that will be achieved and evaluated at the end Phase I that are
directly relevant to the goals of the RFA?
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See additional information and
criteria included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated. (See additional information and Inclusion Criteria in the sections
on Federal Citations, below).
Human Subjects:
o Protection of Human Subjects from Research Risks - for all studies
involving human subjects. See instructions and "Guidance for Preparing the
Human Subjects Research Section." If an exemption is claimed, is it
appropriate for the work proposed? If no exemption is claimed, are the
applicant's responses to the six required points appropriate? Are human
subjects placed at risk by the proposed study? If so, are the risks
reasonable in relation to the anticipated benefits to the subjects and
others? Are the risks reasonable in relation to the importance of the
knowledge that reasonably may be expected to be gained? Are the plans
proposed for the protection of human subjects adequate?
o Inclusion of Women Plan - for clinical research only. Does the applicant
propose a plan for the inclusion of both genders that will provide their
appropriate representation? Does the applicant provide appropriate
justification when representation is limited or absent? Does the applicant
propose appropriate and acceptable plans for recruitment/outreach and
retention of study participants?
o Inclusion of Minorities Plan - for clinical research only. Does the
applicant propose a plan for the inclusion of minorities that will provide
their appropriate representation? Does the applicant provide appropriate
justification when representation is limited or absent? Does the applicant
propose appropriate and acceptable plans for recruitment/outreach and
retention of study participants?
o Inclusion of Children Plan- for all studies involving human subjects. Does
the applicant describe an acceptable plan in which the representation of
children of all ages (under the age of 21) is scientifically appropriate and
recruitment/retention is addressed realistically? If not, does the applicant
provide an appropriate justification for their exclusion?
o Data and Safety Monitoring Plan for clinical trials only. Does the
applicant describe a Data and Safety Monitoring Plan that defines the general
structure of the monitoring entity and mechanisms for reporting Adverse
Events to the NIH and the IRB?
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the required five items described under Vertebrate
Animals (section f of the Research Plan instructions) will be assessed.
Animal Welfare: If vertebrate animals are involved, are adequate plans
proposed for their care and use? Are the applicant's responses to the five
required points appropriate? Will the procedures be limited to those that are
unavoidable in the conduct of scientifically sound research?
Biohazards: Is the use of materials or procedures that are potentially
hazardous to research personnel and/or the environment proposed? Is the
proposed protection adequate?
ADDITIONAL CONSIDERATIONS: The following items may be also be considered by
reviewers but will not be included in the determination of scientific merit.
BUDGET: The reasonableness of the proposed budget may be considered.
For all applications, is the percent effort listed for the PI appropriate for
the work proposed? On applications requesting up to $100,000 total costs, is
the overall budget realistic and justified in terms of the aims and methods
proposed? On applications requesting over $100,000 in total costs, is each
budget category realistic and justified in terms of the aims and methods?
PERIOD OF SUPPORT: The appropriateness of the requested period of support in
relation to the proposed research.
Phase II Application Review Criteria: In addition to the above criteria:
o How well did the applicant demonstrate progress toward meeting the Phase I
objectives, demonstrating feasibility, and providing a solid foundation for
the proposed Phase II activity?
o Did the applicant submit a concise Commercialization Plan [formerly Product
Development Plan] that adequately addresses the seven areas described in the
Research Plan item J?
o Does the project carry a high degree of commercial potential, as described
in the Commercialization Plan?
Amended Applications
In addition to the above criteria, the following criteria will be applied to
revised applications.
o Are the responses to comments from the previous SRG review adequate?
o Are the improvements in the revised application appropriate?
Phase I/Phase II Fast-Track Application Review Criteria
For Phase I/Phase II Fast Track applications, the following criteria also
will be applied:
o Does the Phase I application specify clear, appropriate, measurable goals
(milestones) that should be achieved prior to initiating Phase II?
o Did the applicant submit a concise Commercialization Plan [formerly Product
Development Plan] that adequately addresses the seven areas described in the
Research Plan, item J?
o To what extent was the applicant able to obtain letters of interest,
additional funding commitments, and/or resources from the private sector or
non-SBIR/ STTR funding sources that would enhance the likelihood for
commercialization?
o Does the project carry a high degree of commercial potential, as described
in the Commercialization Plan?
Phase I and Phase II Fast-Track applications that satisfy all of the review
criteria will receive a single rating. Failure to provide clear, measurable
goals may be sufficient reason for the scientific review group to exclude the
Phase II application from Fast-Track review.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: January 19, 2004
Application Receipt Date: February 19, 2004
Peer Review Date: June/July 2004
Council Review: September 2004
Earliest Anticipated Start Date: October 2004
AWARD CRITERIA
Applications submitted in response to an RFA will compete for available funds
with all other recommended SBIR and STTR applications. The following will be
considered in making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
For FAST-TRACK applications, the Phase II portion may not be funded until a
Phase I final report and other documents necessary for continuation have been
received and assessed by program staff that the Phase I milestones have been
successfully achieved.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see
http://stemcells.nih.gov/registry/index.asp). It is the responsibility of
the applicant to provide, in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s)for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final modification
to the "Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a
federal regulation under the Health Insurance Portability and Accountability
Act (HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
RFA is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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