BIOENGINEERING NANOTECHNOLOGY INITIATIVE (supercedes PA-00-018)

RELEASE DATE:  July 2, 2002  (This PA has been reissued as PA-06-008 and PA-06-009)
                             (Scientific program contact change for NLM, see NOT-LM-05-006) 
                             (Program extension, see NOT-HG-05-005)
                             (see also PA-00-018) 
PA NUMBER:  PA-02-125

EXPIRATION DATE:  June 3, 2005, unless reissued. (See NOT-HG-05-005)

National Human Genome Research Institute (NHGRI)
 (http://www.nhgri.nih.gov/)
National Cancer Institute (NCI)
 (http://www.nci.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 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 Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib.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 Institute of General Medical Sciences (NIGMS)
 (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)
National Institute of Nursing Research (NINR)
 (http://www.ninr.nih.gov/)
National Library of Medicine (NLM)
 (http://www.nlm.nih.gov/)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

This Program Announcement (PA), issued as an initiative of the trans-NIH 
Bioengineering Consortium (BECON), invites grant applications for Small 
Business Innovation Research (SBIR) projects on nanotechnologies useful to 
biomedicine.  Nanotechnology is defined as the creation of functional 
materials, devices and systems through control of matter at the scale of 1 to 
100 nanometers, and the exploitation of novel properties and phenomena at the 
same scale.  Nanotechnology is emerging as a field critical for enabling 
essential breakthroughs that may have tremendous potential for affecting 
biomedicine.  Moreover, nanotechnologies developed in the next several years 
may well form the foundation of significant commercial platforms.

In recognition of the nascence of this area, the duration and amounts of 
individual grants awarded under this PA may be greater than those routinely 
allowed under the SBIR program.  Few small businesses possess the highly 
specialized resources needed for nanoengineering.  Therefore, this PA 
encourages team approaches to research in the belief that a synergistic blend 
of expertise and resources may be needed to allow for strong partnerships 
between the small businesses and other entities in Phase I.  Applications are 
encouraged from teams of investigators from commercial, academic and other 
sectors of the research community.  Partners to the small businesses may play 
important roles in these projects and may receive appropriate support for 
their efforts.  In addition to requiring collaboration from various sectors, 
it is expected that this initiative will require expertise from a variety of 
disciplines, including engineering, chemistry, physics, material science, 
engineering, and biology.

This PA must be read in conjunction with the current Omnibus Solicitation of 
the Public Health Service (Omnibus Solicitation) for Phase I SBIR Grant 
Applications available at http://grants.nih.gov/grants/funding/sbir.htm

RESEARCH OBJECTIVES

Background

Nearly half a century ago, the finest minds in physics disagreed as to whether 
it would ever be possible to manipulate individual atoms and electrons.  
Today, the amount of nanoscale science and engineering is exploding because of 
the availability of new investigative tools.  These new analytical tools are 
capable of probing the nanometer world and will make it possible to 
characterize chemical and mechanical properties of cells, discover novel 
phenomena and processes, and provide science with a wide range of tools, 
materials, devices, and systems with unique characteristics.  For example, 
complementing optical traps and tweezers, nanoscale carbon tubes are ideal 
probe tips for scanning microscopy, and could be used to better understand the 
structure of biomolecules.  Carbon nanotubes with bioactive tips could be used 
to serve as chemically-selective grips for particular, individual molecules.  
This capability could be used, in turn, to manipulate and observe directly 
interactions between individual molecules (e.g., proteins) and to detect 
different biological agents and pathogens thus revolutionizing the use of 
probe microscopy in chemistry and biology.  Indeed, by using diverse tools and 
concepts such as scanning probe manipulators, nanolithography, and self-
assembling molecular properties, it should be possible to arrange individual 
atoms and molecules in space with great precision, leading to the fabrication 
of truly smart biosensors.

On the other hand, complex biological systems provide models from which to 
design components that can be brought together to form three-dimensional 
nanostructured systems.  For example, the properties of DNA to undergo highly 
controlled and hierarchical assembly makes it ideal for applications in 
nanotechnology such as molecular sieves, or scaffolds for the assembly of 
molecular electronic components.  Likewise, eukaryotic rotary motors based on 
ATPase could be employed as generic engines driving other nanodevices for 
purposes such as highly directed delivery of drugs or other agents.

Eventually, by coupling advances in the knowledge of living systems with the 
unique capabilities imparted by nanostructures and materials, it may be 
possible to detect and intervene in disease states using biologically inspired 
solutions.  Integration of biocompatible materials with fluidics, optics, 
mechanical and electronic components, all at micro- to nano- scale, will 
enable development of implantable noninvasive sensing systems for the 
detection and prevention of disease at the earliest stages of its development.  
Controlled release delivery systems will make possible delivery of both 
conventional and new, nanostructured drugs at targeted specific sites in the 
body, while nanoscale chemical and topographical details on the surface of 
implantable materials will mediate their reaction with the body.  
Nanotechnology promises scientific and commercial opportunities that are 
virtually unimaginable at this time.

Research Topics

BECON has identified a number of priority areas for nanoscience and 
nanotechnology research support at NIH.   This list is not exhaustive, nor are 
the topics mutually exclusive.  Their presentation here exemplifies important 
scientific areas in which research at the nanoscale has the potential to make 
enormous contributions to solving biomedical problems.  

o  Nanomaterials (enabling):  nano materials science for interfacing with 
living tissues, passive delivery of pharmaceuticals, tissue engineering 
scaffolds, contrast and biological agents, and medical devices.

o  Nanoimaging:  real-time subcellular imaging of structure, function, 
properties and metabolism.

o  Cell biology:  nano-scale research on cellular processes, including 
biophysics of molecular assemblies, membranes, organelles, and 
macromolecules. 

o  Molecular and cellular sensing/signaling:  technologies to detect 
biological signals and single molecules within and outside cells.

o  Nanomotors: understanding structure/function and self-assembly; primary 
and secondary power supply.

o  Prosthetics:  mechanical, chemical, and cellular implant nano-technologies 
to achieve functional replacement tissue architectures.

o  Nanobioprocessor:  implantable nano scale processors that can integrate 
with biological pathways and modify biological processes.

o  Nanosystem design and application: fundamental principles and tools to 
measure and image the biological processes of health and disease; and methods 
to assemble nanosystems.

Examples of general research topics that would be considered responsive to 
this PA are listed below.  This is not meant to be an exhaustive, exclusive or 
delimiting set of topics, rather these merely represent illustrations of 
projects that would be considered relevant to this PA.

o  Nanoplumbing components such as valves, microfluidic channels, and motors 
(e.g., to be used as pumps)

o  Development and improvement of techniques based on new principles for 
probing biological properties and phenomena not well understood at the 
nanometer scale and for characterizing nanoscale materials

o  Development of fluorescent probes at the nanometer scale for monitoring 
biochemical processes on the surface and inside a cell in health and disease

o  Creation of "smart" nanostructured biocompatible materials.  Approaches may 
include self-assembling techniques and supramolecular chemistry for building 
up functional nanostructures and for modifying and patterning material surface 
texture

o  Development of nanofabricated barriers to prevent rejection of implantable 
materials

o  Development of nanoparticles and nanospheres that enable controlled 
released of therapeutic agents, antibodies, genes and vaccines into targeted 
cells

o  Development of sensor technologies for detection and analysis of 
biologically relevant molecular and physical targets in samples from blood, 
saliva and other body fluids, or for use in the research laboratory (purified 
samples), clinical specimens and in the living body.

MECHANISM OF SUPPORT - PHASE I

Phase I applications in response to this PA will be funded as Phase I SBIR 
Grants (R43). As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project.  

Project Period and Amount of Award

Because the duration and cost of research to develop nanotechnologies are 
likely to exceed that routinely awarded for SBIR grants, well-justified Phase 
I applications under this PA will be considered with a project period up to 
two years and a budget not to exceed a total cost of $400,000 (i.e., an 
average of $200,000 per year).

Consultant and contractual costs

Because the resources required for nanoengineering are relatively scarce, 
highly specialized, and multidisciplinary, the total amount of consultant 
costs and contractual costs requested by applicants may exceed the statutory 
guidelines.  Requests in excess of the guidelines must be fully justified.

MECHANISM OF SUPPORT - PHASE II

Phase II applications in response to this PA will be awarded as Phase II SBIR 
grants (R44) with modifications as described below.  Phase II applications in 
response to this PA will only be accepted as competing continuations of 
previously funded NIH Phase I SBIR awards.  The previously funded Phase I 
award need not have been awarded under this PA but the Phase II proposal must 
be a logical extension of the Phase I research.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project.  

Project Period and Amount of Award

Because the duration and cost of research to develop nanotechnologies is 
likely to exceed that routinely awarded for SBIR grants, well-justified Phase 
II applications under this PA will be considered with a project period up to 
three years and a budget not to exceed a total cost of $1,200,000 (i.e., an 
average of $400,000 for each of three years).

Consultant and Contractual Costs

Because the resources required for nanoengineering are relatively scarce, 
highly specialized, and multidisciplinary, the total amount of consultant 
costs and contractual costs requested by applicants may exceed the statutory 
guidelines.  Requests in excess of the guidelines must be fully justified.

ELIGIBLE INSTITUTIONS 

Eligibility requirements for Phase I and Phase II grants are found at 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.

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.

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 three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

NCI – Ed Monachino, Ph.D.; National Cancer Institute; Building 31, Room 10A49, 
MSC 2580, Bethesda, MD 20892-2580; Telephone:  (301) 496-1550; FAX:  (301) 
496-7807; Email: monachie@mail.nih.gov

NEI – Richard S. Fisher, Ph.D.; National Eye Institute; Executive Plaza South, 
Suite 350; 6120 Executive Boulevard, MSC 7164; Bethesda, MD  20892-7164; 
Telephone:  (301) 451-2020; FAX:  (301) 402-0528; Email:  rf75s@nih.gov

NHLBI – NHLBI - John T. Watson, Ph.D.; National Heart, Lung, and Blood 
Institute; 6701 Rockledge Drive, Room 9166; Bethesda, MD  20892-7940; 
Telephone:  (301) 435-0555; FAX:  (301) 480-7971; Email:  jw53f@nih.gov

NHGRI - Jeffery A. Schloss, Ph.D.; Division of Extramural Research; National 
Human Genome Research Institute; Building 31, Room B2B07, MSC 2033; Bethesda, 
MD  20892-2033; Telephone:  (301) 496-7531; FAX:  (301) 480-2770; Email: 
jeff_schloss@nih.gov

NIA – Winifred K. Rossi, M.A.; Geriatrics and Clinical Gerontology;  National 
Institute on Aging; Gateway Building, Suite 3E327, MSC 9205; Bethesda, MD  
20892-9205; Telephone:  (301) 496-3836; FAX:  (301) 402-1784; Email:  Email: 
rossiw@nia.nih.gov 

NIAAA -Michael Eckardt, Ph.D.; Office of Scientific Affairs; Institute on 
Alcohol Abuse and Alcoholism; Suite 409; 6000 Executive Blvd.; Bethesda, MD  
20892-7003; Telephone: (301) 443-6107; Fax: (301) 443-6077; Email: 
me25t@nih.gov

NIAID – Maria Y. Giovanni, Ph.D.; Division of Microbiology and Infectious 
Disease; National Institute of Allergy and Infectious Diseases; 6700-B 
Rockledge Dr. MSC 7630; Bethesda, MD 20892-7630; Telephone:  (301) 496-1884;  
FAX: (301) 480-4528; Email:  mgiovanni@niaid.nih.gov

NIAMS - James S. Panagis, M.D., M.P.H.; Orthopaedics Program; National 
Institute of Arthritis and Musculoskeletal and Skin Diseases; Bethesda, MD  
20892-6500; Telephone:  (301) 594-5055; Email:  jp149d@nih.gov

NIBIB – Joan T. Harmon, Ph.D.; Division of Bioengineering; National Institute 
of Biomedical Imaging and Bioengineering; 6707 Democracy Boulevard, Room 956; 
Bethesda, MD  20892-5469; Telephone: (301) 451-4776; FAX:  (301) 480-4973; 
Email: joan_harmon@nih.gov

NIDCD - Lynn E. Luethke, Ph.D.; National Institute on Deafness and Other 
Communication Disorders; 6120 Executive Boulevard, MSC 7180; Bethesda, MD 
20892-7180; Telephone:  (301) 402-3458; FAX:  (301) 402-6251; Email: 
lynn_luethke@nih.gov

NIDCR - Eleni Kousvelari, D.D.S., D.Sc.; Cellular and Molecular Biology, 
Physiology and Biotechnology Branch; National Institute of Dental and 
Craniofacial Research; Natcher Building, Room 4AN 18A, MSC 6402; Bethesda, MD 
20892-6402; Telephone:  (301) 594-2427; FAX:  (301) 480-8318; Email: 
kousvelari@de45.nidr.nih.gov

NIDDK - Thomas Eggerman, Ph.D.; Division of Diabetes, Endocrinology, and 
Metabolic Diseases; National Institute of Diabetes and Digestive and Kidney 
Diseases; 6706  Democracy Blvd., Room 697, MSC 5460, Bethesda, MD, 20895-5460, 
Telephone:  (301) 594-8813; FAX:  (301) 480-3503; Email: 
EggermanT@extra.niddk.nih.gov

NIDA - Thomas G. Aigner, Ph.D.; Division of Basic Research; National Institute 
on Drug Abuse; 6001 Executive Boulevard, Room 4282, MSC 9555; Bethesda, MD 
20892-9555; Telephone:  (301) 443-6975; FAX:  (301) 594-6043; Email:  
ta17r@nih.gov

NIEHS - Dr. Claudia Thompson; Division of Extramural Research and Training; 
National Institute of Environmental Health Sciences; PO Box 12233, Mail Drop 
EC-23; Research Triangle Park, NC  27709; Telephone:  (919) 541-4638; FAX:  
(919) 541-5064; Email: ct68w@nih.gov

NIGMS –Catherine Lewis, Ph.D.;  Bldg. 45, Rm 2AS-13K; 45 Center Dr.; Bethesda, 
MD 20892-6200; Telephone: 301-594-0828; FAX:  (301) 480-2004; Email: 
lewisc@nigms.nih.gov

NIMH – Margaret Grabb, Ph.D.; Division of Neuroscience and Basic Behavioral 
Science; National Institute of Mental Health; 6001 Executive Boulevard, Room 
7202, MSC 9645; Bethesda, MD  20892-9645; Telephone:  (301) 443-3563; FAX:  
(301) 443-1731; Email: mgrabb@mail.nih.gov

NINR - Hilary Sigmon, Ph.D.; Cardiopulmonary Health & Critical Care; National 
Institute of Nursing Research; Building 45, Room 3AN12;  45 Center Drive;  
Bethesda, Maryland 20892-6300; Telephone:  (301) 594-5970; FAX: (301) 480-
8260; Email:  hsigmon@ep.ninr.nih.gov 

NLM - Dr. Hua-Chuan Sim, 6705 Rockledge Drive, Suite 301, MSC 7968
Bethesda, MD 20892-7968, Bethesda, MD 20817 (for courier/express service)
Telephone: (301) 496-4253, FAX: (301) 402-2952, Email: simh@mail.nih.gov

o Direct your questions about financial or grants management matters to:

NCI - Bill Wells; Grants Administration Branch; National Cancer Institute; 
6120 Executive Boulevard, Room 243, MSC 7150; Bethesda, MD  20892-7150; 
Telephone:  (301) 496-7800; FAX:  (301) 496-8601; Email: 
wellsw@gab.nci.nih.gov

NEI – William Darby, Grants Management Officer; National Eye Institute; 6120 
Executive Boulevard, Suite 350, MSC 7164; Bethesda, MD  20892-7164; Telephone:  
(301) 451-2020; FAX:  (301) 402-0528; Email:  wwd@nei.nih.gov

NHLBI - Jane Davis; National Heart, Lung, and Blood Institute; 6701 Rockledge 
Drive, Room 7174; Bethesda, MD  20892; Telephone:  (301) 435-0166; FAX:  (301) 
480-3310; Email: jd53f@nih.gov

NHGRI - Jean Cahill; Grants Management Office; National Human Genome Research 
Institute; Building 31, Room B2B34;  31 Center Drive,  MSC 2030;  Bethesda, MD 
20892-2030; Telephone:  (301) 402-0733; FAX:  (301) 402-1951; Email:  
jean_cahill@nih.gov

NIA - Linda Whipp; Grants and Contracts Management Officer; National 
Institute on Aging; Gateway Building, Suite 2N212; Bethesda, MD  20892; 
Telephone:  (301) 496-1472; FAX:  (301) 402-3672; Email: Whippl@nia.nih.gov

NIAAA - Judy Simons; Grants Management Officer; National Institute on Alcohol 
Abuse and Alcoholism; 6000 Executive Blvd., Suite 504; Bethesda, MD 20892-
7003; Telephone: (301) 443-4704; Fax: (301) 443-3891; Email: 
jsimons@willco.niaaa.nih.gov

NIAID – Lesia Norwood; Division of Extramural Activities; National Institute 
of Allergy and Infectious Diseases; Room 3221, MSC-7614; 6700-B Rockledge 
Drive; Bethesda, MD  20892-7614; Telephone:  (301) 402-6581; FAX:  (301) 480-
3780; Email:  ln5t@nih.gov

NIAMS – Melinda Nelson; Grants Management Branch; National Institute of 
Arthritis and Musculoskeletal and Skin Diseases; Bethesda, MD  20892-6500; 
Telephone:  (301) 594-3535; Email:  nelsonm@mail.nih.gov

NIBIB - Ms. Annette Hanopole; Grants Management Officer; National Institute 
of Biomedical Imaging and Bioengineering; 6707 Democracy Boulevard; Bethesda, 
MD  20892-5469; Telephone:  301-451-4789; Fax:  301-480-4973; Email:  
hanopola@nibib.nih.gov

NIDCD - Sharon Hunt; Grants Management Branch; National Institute on Deafness 
and Other Communication Disorders; 6120 Executive Boulevard, Room 400-C, MSC 
7180; Bethesda, MD  20892-7180; Telephone:  (301) 402-0909; FAX:  (301) 402-
1758; Email: sharon_hunt@nih.gov

NIDCR - Kevin Crist; Division of Extramural Research; National Institute of 
Dental and Craniofacial Research; Natcher Building, Room 4AS 55; Bethesda, MD  
20892-6402; Telephone:  (301) 594-4800; FAX:  (301) 480-8301; Email: 
Kevin.Crist@nih.gov

NIDDK - Kathleen J. Shino, MBA; Grants Management Branch; National Institutes 
of Diabetes and Digestive and Kidney Diseases;  6707 Democracy Blvd., Room 
708; Bethesda, MD 20892;  Telephone:  (301) 594-8869; FAX:  (301) 594-9523; 
Email:  shinok@extra.niddk.nih.gov

NIDA - Gary Fleming, J.D., M.A.; Grants Management Branch; National Institute 
on Drug Abuse; 6001 Executive Boulevard, Room 3131, MSC 9541; Bethesda, MD 
20892-9541; Telephone:  (301) 443-6710; FAX:  (301) 594-6847; Email: 
gf6s@nih.gov

NIEHS – Dorothy Duke; Division of Extramural Research and Training; National 
Institute of Environmental Health Sciences; P.O. Box 12233, Mail Drop EC-22; 
Research Triangle Park, NC  27709; Telephone:  (919) 541-1373; FAX:  (919) 
541-2860; Email: Duke3@niehs.nih.gov

NIGMS - Grace Tuanmu; Grants Management, CBB; National Institute of General 
Medical Sciences; 45 Center Drive MSC 6200; Room 2AN.32E; Bethesda, Md.  
20892-6200; Telephone:  (301) 594 5520; FAX:  (301) 480 2554; Email 
tuanmug@nigms.nih.gov 

NIMH - Kathy Hancock; Grants Management Branch; National Institute of Child 
Health and Human Development; 6100 Executive Boulevard, Room 8A17M; Bethesda, 
MD  20892-7510; Telephone:  (301) 496-5482; FAX:  (301) 402-0915; Email:  
hancockk@mail.nih.gov

NINR – Cynthia McDermott; Office of Grants and Contracts Management; National 
Institute of Nursing Research;  Building 45, Room 3AN12; 45 Center Drive; 
Bethesda, Maryland 20892-6300; Telephone:  301-594-6869;  FAX:  301-480-8260;  
Email:  mcdermot@mail.nih.gov

NLM – J. Christopher Robey, M.A; Division of Extramural Programs; National 
Library of Medicine; Rockledge One, Suite 301; 6705 Rockledge Drive; 
Bethesda, MD 20817 (For courier delivery service use: 20817); Telephone:  
(301) 594-4937; FAX:  (301) 402-0421; Email:  robeyj@mail.nlm.nih.gov 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  Suggest cite specific Small Business Section.  For further 
assistance contact GrantsInfo, Telephone (301) 435-0714, Email: 
GrantsInfo@nih.gov.

For purposes of identification and processing, the title and number of this 
PA must be shown in item 2 on the face page of the application (i.e., 
"BIOENGINEERING NANOTECHNOLOGY INITIATIVE," PA-02-125)

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

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
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  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 application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
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 Receive a written critique
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 second level review by the appropriate national advisory council 
or board
	
REVIEW CRITERIA

Review criteria are described in the Omnibus Solicitation 
(http://grants.nih.gov/grants/funding/sbirsttr_ReviewCriteria.htm).  
The Phase I application should specify clear, measurable goals (milestones) 
that should be achieved prior to initiating Phase II.  Failure to provide 
clear, measurable goals may be sufficient reason for the study section to 
judge the application non-competitive. 

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended 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

REQUIRED FEDERAL CITATIONS 

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 AMENDMENT "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://grants.nih.gov/grants/stem_cells.htm 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 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.

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 No. 93.394 (NCI); 93.387 (NEI); 93.233, 93.837, 
93.838, 93.839 (NHLBI); 93.172 (NHGRI); 93.866 (NIA); 93.271 (NIAAA); 93.856 
(NIAID); 93.846 (NIAMS); 93.286, 93.287 (NIBIB); 93.173 (NIDCD); 93.121 
(NIDCR); 93.849, 93.848 and 93.847 (NIDDK); 93.279 (NIDA); 93.114 (NIEHS); 
93.821, 93.859, 93.862 (NIGMS); 93.242 (NIMH); 93.361 (NINR); 93.879 (NLM) 
and is not subject to the intergovernmental review requirements of Executive 
Order 12372 or Health Systems Agency review.  Awards are made under 
authorization of Sections 301 and 405 of the Public Health Service Act as 
amended (42 USC 241 and 284) and administered under NIH grants policies 
described at http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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