and Human Services (HHS)
EXPIRED
MANUFACTURING PROCESSES OF MEDICAL, DENTAL, AND BIOLOGICAL TECHNOLOGIES (SBIR/STTR)
RELEASE DATE: September 29, 2004
PA NUMBER: PA-04-161 (This PA has been reissued, see PA-06-012 and PA-06-013)
(Contact change for NLM, see NOT-LM-05-006)
EXPIRATION DATE: October 20, 2005
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
Center for Disease Control and Prevention (CDC)
(http://www.cdc.gov)
Food and Drug Administration (FDA)
(http://www.fda.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute on Aging (NIA)
(http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov/)
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS)
(http://www.niehs.nih.gov/)
National Eye Institute (NEI)
(http://www.nei.nih.gov/)
National Institute of General Medical Sciences (NIGMS)
(http://www.nigms.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov/)
National Institute of Mental Health (NIMH)
(http://www.nimh.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 Center for Research Resources (NCRR)
(http://www.ncrr.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM)
(http://nccam.nih.gov)
National Library of Medicine (NLM)
(http://www.nlm.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):
93.394 (NCI); 93.867 (NEI); 93.233, 93.837,93.838, 93.839 (NHLBI); 93.866
(NIA); 93.273 (NIAAA); 93.856; (NIAID); 93.286, 93.287 (NIBIB); 93.173
(NIDCD); 93.121; (NIDCR); 93.849, 93.848 and 93.847 (NIDDK); 93.279 (NIDA);
93.113, 93.114, 93.115 (NIEHS); 93.859 (NIGMS); 93.242 (NIMH); 93.853
(NINDS); 93.361 (NINR); 93.879 (NLM); 93.103 (FDA); 93.061 (CDC)
APPLICATION RECEIPT DATE(S): Applications submitted in response to this
program announcement will be accepted at the standard application deadlines
[April 1, August 1, December 1]
THIS PA CONTAINS THE FOLLOWING INFORMATION:
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Funds Available (include for PAS only)
o Project Period and Amount of Award
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Receipt and Review Schedule
o Required Federal Citations
NOTICE: This program announcement (PA) 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 [PDF] or
http://grants.nih.gov/grants/funding/sbirsttr1/index.doc (MS Word] contains
information about the SBIR and STTR programs, regulations governing the
programs, and instructional information for submission. All of the
instructions and review criteria within the current SBIR/STTR Omnibus
Solicitation apply.
PURPOSE OF THE PA
On February 26, 2004, Executive Order 13329
(http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov
/2004/pdf/04-4436.pdf)was signed by President George W. Bush requiring
SBIR/STTR agencies, to the extent permitted by law and in a manner consistent
with the mission of the Department, to give high priority within the SBIR and
STTR programs to manufacturing-related research and development (R&D). In
response to this Executive Order, NIH, CDC, and the FDA are expanding their
foci by encouraging biomedical research related to advanced processing,
manufacturing processes, equipment and systems, and manufacturing workforce
skills and protection.
RESEARCH OBJECTIVES
The NIH, CDC, and FDA encourage research related to advanced processing in
the manufacture of biomedical products and the implementation of new
technologies in medical care. New methods, procedures, measures, and
controls are needed for manufacturing a broad range of technologies and
products with unsurpassed quality and to lower manufacturing costs for
existing and/or new processes. Research is also encouraged that can
contribute to the containment and reduction of health care costs and that can
improve the cost effectiveness, quality, and accessibility of the health care
system.
Manufacturing-related R&D is defined as:
Manufacturing innovation is fostered by research and development of
technologies that are aimed at increasing the competitive capability of
manufacturing concerns. Broadly speaking, manufacturing-related R&D
encompasses improvements in existing methods or processes, or wholly new
processes, machines or systems. Four main areas include:
Unit process level technologies that create or improve manufacturing
processes, including (1) fundamental improvements in existing manufacturing
processes that deliver substantial productivity, quality, or environmental
benefits, and (2) development of new manufacturing processes, including new
materials, coatings, methods, and practices associated with these processes.
Machine level technologies that create or improve manufacturing equipment,
including (1) improvements in capital equipment that create increased
capability (such as accuracy or repeatability), increased capacity (through
productivity improvements or cost reduction), or increased environmental
efficiency (safety, energy efficiency, environmental impact), and (2) new
apparatus and equipment for manufacturing, including additive and subtractive
manufacturing, deformation and molding, assembly and test, semiconductor
fabrication, and nanotechnology.
Systems level technologies for innovation in the manufacturing enterprise,
including (1) advances in controls, sensors, networks, and other information
technologies that improve the quality and productivity of manufacturing
cells, lines, systems, and facilities; (2) innovation in extended enterprise
functions critical to manufacturing, such as quality systems, resource
management, supply chain integration, and distribution, scheduling and
tracking; and (3) technologies that enable integrated and collaborative
product and process development, including computer-aided and expert systems
for design, tolerancing, process and materials selection, life-cycle cost
estimation, rapid prototyping, and tooling.
Environment or societal level technologies that improve workforce abilities
and manufacturing competitiveness, including (1) technologies for improved
workforce health and safety, such as human factors and ergonomics; and (2)
technologies that aid and improve workforce manufacturing skills and
technical excellence, such as educational systems incorporating improved
manufacturing knowledge and instructional methods
Because manufacturing-related R&D is extremely broad in scope, the following
examples of research topics may be of interest but are not meant to be
exhaustive.
o Flexible computer-assisted integrated manufacturing equipment and
intelligent processing equipment adaptable to the varied needs of biomedical
research and medical care device and material production.
o Systems engineering and management tools needed for the development of
biomedical product manufacturing plants with particular emphasis on the
requirements to meet GMP requirements for FDA approvals.
o Technology for the manufacture of research instrumentation, such as highly
sensitive, high resolution spectrometers, highly selective electrodes,
microarray devices, and microfluidic devices.
o Technology for the manufacture of clinical diagnostic devices and reagents.
Technology for the manufacture of novel diagnostic imaging devices for both
invasive and non-invasive techniques.
o Technology for the manufacture and delivery of therapeutic drugs, including
for example, synthetic process chemistry, separations methods, formulation,
and dosage delivery.
o Technology for the manufacture of implantable devices and materials,
including drug delivery pumps, prosthetic organs, artificial tissues,
electronic sensors and electrical stimulators.
o Technology for the production of natural products derived from plant,
animal, and microbial sources, such as antibiotics, anticancer drugs, and
other therapeutic agents, and useful synthetic starting materials.
o Technology for the production and isolation of biotechnology products, such
as proteins, antibodies, nucleic acids, vaccines, and vectors for genetic
engineering and gene therapy.
o Technology for the production of new materials relevant to biomedical
research and medical care delivery, including nanomaterials, carbon fibers,
polymeric materials, self-assembled monolayers, controlled size, shape, and
porosity particles, filters, membranes, silicon substrates for microarrays,
superconducting materials for NMR and MRI magnets, and implantable magnetic
materials for external magnetic manipulation.
o Technology for manufacture of medical device power sources, such as high
energy density, long life-time batteries, solar cells, and fuel cells.
o Technology for the fabrication of medical care instruments and devices such
as minimally invasive and magnetic field tolerant surgical instruments,
orthopedic implants, prostheses, and enabling devices for the injured and
disabled.
o Rapid prototyping and manufacture technology suitable for remote site and
on demand production processes.
o Technology to promote the recovery, reuse, and remanufacture (recycling) of
medical materials and equipment.
o Technology for the manufacture of biomedically specialized computational
and information technology equipment and software.
o Development of innovative products that facilitate the safety and health
training of hazardous materials workers, emergency responders, and skilled
support personnel. (See also NIEHS Worker Education and Training Program at
http://www.niehs.nih.gov/wetp/home.htm.
Many specific topics listed in Part II of the NIH SBIR/STTR Omnibus
Solicitation of the National Institutes of Health, Centers for Disease
Control and Prevention, and Food and Drug Administration
(http://grants.nih.gov/grants/funding/sbirsttr1/2005-2_SBIR-STTR-topics.pdf)
could also be considered relevant to manufacturing. Potential applicants are
encouraged to review this material for additional indications of NIH areas of
interest.
MECHANISM(S) OF SUPPORT
This PA 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.
This PA 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 budget 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_2003/NIHGPS_Part2.htm#matching_or
_cost_sharing
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 PA 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 PA.
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.
ELIGIBLE INSTITUTIONS:
Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation.
Only small business concerns are eligible to submit 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 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 their 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 your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two
areas: scientific/research and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Michael-David Kerns, Ph.D.
National Institute on Aging
Gateway Building, Room 2C218,
7201 Wisconsin Avenue, Bethesda, MD 20892-9205;
Telephone: (301) 496-9322
FAX: (301) 402-2945
Email: [email protected]
Karen P. Peterson, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 451-3883
FAX: (301) 443-7043
Email: [email protected]
Gregory Milman, Ph.D.
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Room 2153, MSC-7610
6700-B Rockledge Drive
Bethesda, MD 20892-7610
Telephone (301) 496-8666
FAX: (301) 402-0369
Email: [email protected]
Todd Merchak
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd., MSC 5477
Bethesda, MD 20892-5477
Telephone: (301) 496-8592
FAX: (301) 480-1614
Email: [email protected]
Greg Downing, Ph.D.
National Cancer Institute
Office of Technology and Industrial Relations
31 Center Drive; Room 10A52, MSC 2580
Bethesda, MD 20852
Telephone: (301) 496-1550
FAX: 496-7807
Email: [email protected]
Cathrine Sasek, Ph.D.
National Institute on Drug Abuse
6001 Executive Blvd, MSC 9591
Bethesda, MD 20892-9591
Telephone: (301) 443-6071
FAX: (301) 443-6277
Email: [email protected]
Lynn E. Luethke, Ph.D.
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
FAX: (301) 402-6251
Email: [email protected]
Rosemarie Hunziker, Ph.D.
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4An.24K
Bethesda, MD 20892-6402
Telephone: (301) 451-3888
FAX: (301) 480-8318
E-mail: [email protected]
Sanford A. Garfield, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 685
Bethesda, MD 20892
Telephone: (301) 594-8803
FAX: (301) 402-6271
Email: [email protected]
Jerry Heindel, Ph.D.
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive,4401 Bldg, 3rd Floor
Research Triangle Park, NC, 27709
Telephone: (919) 541-0781
FAX (919)541-5064
Email: [email protected]
Ralph J. Helmsen, Ph.D.
National Eye Institute
Suite 1300, 5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528
Email: [email protected]
Peter Preusch, Ph.D.
National Institute of General Medical Sciences
45 Center Drive; Room 2As.43j; MSC 6200
Bethesda, MD 20892
Telephone: (301) 594-5938
FAX: (301) 480-2802
Email: [email protected]
Bishow Adhikari, Ph.D.
National Heart, Lung and Blood Institute
6701 Rockledge Dr, Room 9161; MSC 7940
Bethesda, MD 20892
Telephone: (301) 435-0513
FAX: 301-480-1335
Email: [email protected]
Margaret Grabb, Ph.D.
National Institute of Mental Health
6001 Executive Blvd., Room 7204, MSC 9645
Bethesda, MD 20892
Telephone: (301) 443-3563
FAX: (301) 443-1731
Email: [email protected]
Thomas Miller, Ph.D.
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2139
Bethesda, MD 20892-9527
Telephone: (301) 496-1779
FAX: (301) 402-1501
Email: [email protected]
Yvonne Bryan, Ph.D.
National Institute of Nursing Research
6701 Democracy Blvd., Room 710; MSC 4870
Bethesda, MD 20892-0001
Telephone: (301) 594-6908
FAX: (301) 480-8260
Email: [email protected]
Amy L. Swain, Ph.D.
National Center for Research Resources
6701 Democracy Blvd., MSC 4874
Bethesda, MD 20879-4874
Telephone: (301) 435-0752
FAX: 301-402-3659
Email: [email protected]
Shan S. Wong, Ph.D.
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., MSC 5475
Bethesda, MD 20892-5475
Telephone: (301) 496-7498
FAX: (301) 480-3621
Email: [email protected].
Charles Friedman, Ph.D.
National Library of Medicine
6705 Rockledge Drive, Room 301
Bethesda, MD 20892
Telephone: (301) 594-4927
FAX: 301-402-2951
Email: [email protected]
Curtis L. Bryant
Centers for Disease Control and Prevention
Procurement & Grants Office
2920 Brandywine Road
Atlanta, GA 30341
Telephone: (770) 488-2806
FAX: (770) 488-2828
Email: [email protected]
Rosemary Springer
Food and Drug Administration
Division of Contracts and Grants Management
5600 Fishers Lane, HFA-531
Rockville, MD 20857
Telephone: (301) 827-7182
FAX: (301) 827-7101
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Ms. Linda Whipp
National Institute on Aging
Gateway Building, Room 2N212
Bethesda, MD 20892
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: [email protected]
Ms. Judy Fox
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: [email protected]
Ms. Pamela Fleming
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Room 2119, MSC 7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-6580
FAX: (301) 480-3780
Email: [email protected]
Ms. Florence Turska
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd., MSC 5469
Bethesda, MD 20892-5469
Telephone: (301) 496-9314
FAX: (301) 480-5735
Email: [email protected]
Mr. Ted Williams
National Cancer Institute
6120 Exec Blvd, Room 243; MSC 7150
Bethesda, MD 20892
Telephone: (301) 496-8785
FAX: (301) 496-8601
Email: [email protected]
Mr. Gary Fleming
National Institute on Drug Abuse
6101 Executive Blvd, MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected].
Mr. Christopher Myers
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., Room 400B, MSC 7180
Bethesda, MD 20892
Telephone: (301) 402-0909
FAX: (301) 402-1758
Email: [email protected]
Ms. Mary Daley
National Institute of Dental and Craniofacial Research
45 Center Drive Bldg. 45, Rm. 4AN44B; MSC 6402
Bethesda, MD 20892-6402
Telephone: (301) 594-4808
FAX: (301) 480-3562
Email: [email protected]
Ms. Helen Y. Ling
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 732
Bethesda, MD 20892
Telephone: (301) 594-8857
FAX: (301) 480-3504
Email: [email protected]
Mr. Dwight Dolby
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive, 4401 Bldg, 3rd Floor
Research Triangle Park, NC, 27709
Telephone: (919) 541-7824
FAX: (919) 541-2860
Email: [email protected]
Mr. William Darby
National Eye Institute
Suite 1300, 5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 496-9997
Email: [email protected]
Ms. Patrice Molnar
National Institute of General Medical Sciences
45 Center Drive MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 534-5136
FAX: (301) 480-2554
E-Mail: [email protected]
Ms. Suzanne White
National Heart, Lung and Blood Institute
6701 Rockledge Dr.; MSC 7926
Bethesda, MD 20892
Telephone: (301) 435-0144
FAX: (301) 480-3310
Email: [email protected]
Mr. Brian Albertini
National Institute of Mental Health
6001 Executive Blvd., MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-0004
FAX: (301) 443-6885
Email: [email protected]
Ms. Kathleen Howe
National Institute of Neurological Disorders and Stroke
6001 Exec Blvd.; MSC 9531
Bethesda, MD 20892
Telephone: (301) 496-9231
FAX: (301) 402-0219
Email: [email protected]
Ms. Teresa Farris Marquette
National Institute of Nursing Research
6701 Democracy Blvd, Room 710; MSC 4870
Bethesda, MD 20892
Telephone: (301) 594-2177
FAX: (301) 402-4502
Email: [email protected]
Ms. Alice Chi
National Center for Research Resources
6701 Democracy Blvd., MSC 4874
Bethesda, MD 20879-4874
Telephone: (301) 435-0857
FAX: (301) 435-480-3777
Email: [email protected]
Mr. George Tucker
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd.; MSC 5475
Bethesda, MD 20892-5475
Telephone: (301) 594-9102
FAX: (301) 480-1552
Email: [email protected].
Mr. Dwight Mowery
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Telephone: (301) 496-4221
FAX 301 402-0421
Email: [email protected]
Ms. Sharron Orum
Centers for Disease Control and Prevention
2920 Brandywine Road
Atlanta, GA 30341
Telephone: (770) 488-2716
FAX: (770) 488-2777
Email: [email protected]
Ms. Rosemary Springer
Food and Drug Administration
Division of Contracts and Grants Management
5600 Fishers Lane, HFA-531
Rockville, MD 20857
Telephone: (301) 827-7182
FAX: (301) 827-7101
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, applications 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].
The title and number of this PA 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 five 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)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described on the first page of this program announcement. The CSR will
not accept any application in response to this PA 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. This does not preclude the
submission of a substantial revision of an unfunded version of an application
already reviewed, but such application must include an Introduction
addressing the previous critique.
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.
PEER REVIEW PROCESS
Applications submitted for this PA that are complete will be assigned on the
basis of established PHS referral guidelines. Appropriate scientific review
groups convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the 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:
o Significance
o Approach
o Innovation
o Investigator
o Environment
ALL SBIR/STTR APPLICATIONS
1. 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?
2. 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?
3. Innovation: Does the project challenge existing paradigms or employ novel
technologies, approaches or methodologies? Are the aims original and
innovative?
4. 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?
5. 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 applied to ALL applications in the determination of scientific
merit and the priority score:
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).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
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:
1. 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?
2. 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?
3. 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?
4. 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?
5. 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.
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 REVIEW CONSIDERATIONS: The following items may be also be
considered by reviewers but will not be included in the determination of
scientific merit.
SHARING RESEARCH DATA: Applicants requesting $500,000 or more in direct
costs in any year of the proposed research must include a data sharing plan
in their application. The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or priority score.
(http://grants.nih.gov/grants/policy/data_sharing)
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 APPLICATIONS: In addition to the above review criteria:
1. 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?
2. Did the applicant submit a concise Commercialization Plan that adequately
addresses the seven areas described in the Research Plan item J?
3. 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.
1. Are the responses to comments from the previous SRG review adequate?
2. 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:
1. Does the Phase I application specify clear, appropriate, measurable goals
(milestones) that should be achieved prior to initiating Phase II?
2. Did the applicant submit a concise Commercialization Plan that adequately
addresses the seven areas described in the Research Plan, item J?
3. 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?
4. 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.
AWARD CRITERIA
Applications submitted in response to a PA 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.
RECEIPT AND REVIEW SCHEDULE
See http://grants1.nih.gov/grants/funding/sbirsttr_receipt_dates.htm
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).
SHARING RESEARCH DATA: Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing
Investigators should seek guidance from their institutions, on issues related
to institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers will
consider the data sharing plan but will not factor the plan into the
determination of the scientific merit or the priority score.
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.
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://escr.nih.gov).
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 PA 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).
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://grants1.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 PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
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
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||