U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PHS 2006-2

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

NIH, CDC, and FDA Program Descriptions and\
Research Topics

Table of Contents

NIH, CDC, and FDA Program Descriptions and Research Topics

[**National Institutes of Health (NIH)
1**](#__RefHeading___Toc124236865)

[Trans-NIH Research Programs 1](#__RefHeading___Toc124236866)

[Phase II Competing Renewal Awards 1](#__RefHeading___Toc124236867)

[Bioengineering Nanotechnology Initiative
2](#__RefHeading___Toc124236868)

[Manufacturing Processes of Medical, Dental, and Biological
Technologies\
(STTR \[R41/R42\]) 2](#__RefHeading___Toc124236869)

[Development of Synthetic and Natural Biomaterial Reference Materials
3](#__RefHeading___Toc124236870)

[National Center on Sleep Disorders Research
4](#__RefHeading___Toc124236871)

[National Institute on Aging (NIA) 5](#__RefHeading___Toc124236872)

[Behavioral and Social Research 5](#__RefHeading___Toc124236873)

[Biology of Aging 8](#__RefHeading___Toc124236874)

[Neuroscience and Neuropsychology of Aging
9](#__RefHeading___Toc124236875)

[Geriatrics and Clinical Gerontology 10](#__RefHeading___Toc124236876)

[Phase II Competing Renewal Awards 5](#__RefHeading___Toc124236877)

[Other Research Topic(s) Within the Mission of the Institute
12](#__RefHeading___Toc124236878)

[National Institute on Alcohol Abuse and Alcoholism (NIAAA)
12](#__RefHeading___Toc124236879)

[Phase II Competing Renewal Awards 12](#__RefHeading___Toc124236880)

[Pharmaceutical Development for Alcoholism Treatment
13](#__RefHeading___Toc124236881)

[Diagnostic Assessment of Alcohol Use Disorders and Comorbidity
13](#__RefHeading___Toc124236882)

[Treatment of Alcoholism 14](#__RefHeading___Toc124236883)

[Measurement of Alcohol Consumption/Impairment
14](#__RefHeading___Toc124236884)

[Promoting Adherence to Medical, Pharmacologic, and Behavioral
Treatments 15](#__RefHeading___Toc124236885)

[Prevention 15](#__RefHeading___Toc124236886)

[Health Services Research on Alcohol-Related Problems
16](#__RefHeading___Toc124236887)

[Training in Alcoholism Assessment and Treatment Techniques
16](#__RefHeading___Toc124236888)

[Fetal Alcohol Syndrome (FAS) and Alcohol-Related Birth Defects
17](#__RefHeading___Toc124236889)

[Science Education 17](#__RefHeading___Toc124236890)

[Longitudinal Analysis of Complex Survey Data
18](#__RefHeading___Toc124236891)

[Research Tools 18](#__RefHeading___Toc124236892)

[Development and Clinical Testing of Biochemical Markers
18](#__RefHeading___Toc124236893)

[Other Research Topic(s) Within the Mission of the Institute
19](#__RefHeading___Toc124236894)

[National Institute of Allergy and Infectious Diseases (NIAID)
19](#__RefHeading___Toc124236895)

[Phase II Competing Renewal Awards 20](#__RefHeading___Toc124236896)

[Division of AIDS 20](#__RefHeading___Toc124236897)

[Division of Allergy, Immunology, and Transplantation
22](#__RefHeading___Toc124236898)

[Division of Microbiology and Infectious Diseases
23](#__RefHeading___Toc124236899)

[Other Research Topic(s) Within the Mission of the Institute
25](#__RefHeading___Toc124236900)

[National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS) 25](#__RefHeading___Toc124236901)

[Arthritis and Musculoskeletal and Skin Diseases
25](#__RefHeading___Toc124236902)

[Markers of Osteoarthritis 27](#__RefHeading___Toc124236903)

[Muscle Biology, Exercise Physiology and Sports Medicine
27](#__RefHeading___Toc124236904)

[Other Research Topic(s) Within the Mission of the Institute
28](#__RefHeading___Toc124236905)

[National Institute of Biomedical Imaging and Bioengineering (NIBIB)
29](#__RefHeading___Toc124236906)

[Other Research Topic(s) Within the Mission of the Institute
31](#__RefHeading___Toc124236907)

[National Cancer Institute (NCI) 31](#__RefHeading___Toc124236908)

[Center to Reduce Cancer Health Disparities
32](#__RefHeading___Toc124236909)

[Division of Cancer Biology 32](#__RefHeading___Toc124236910)

[Division of Cancer Control and Population Sciences
38](#__RefHeading___Toc124236911)

[Division of Cancer Treatment and Diagnosis
39](#__RefHeading___Toc124236912)

[Division of Cancer Prevention 47](#__RefHeading___Toc124236913)

[Other Research Topic(s) Within the Mission of the Institute
50](#__RefHeading___Toc124236914)

[National Institute of Child Health and Human Development (NICHD)
51](#__RefHeading___Toc124236915)

[Phase II Competing Renewal Awards 52](#__RefHeading___Toc124236916)

[Population Research 52](#__RefHeading___Toc124236917)

[Research for Mothers and Children 54](#__RefHeading___Toc124236918)

[Developmental Biology & Perinatal Medicine Research
55](#__RefHeading___Toc124236919)

[Medical Rehabilitation Research 55](#__RefHeading___Toc124236920)

[Other Research Topic(s) Within the Mission of the Institute
56](#__RefHeading___Toc124236921)

[National Institute on Drug Abuse (NIDA)
56](#__RefHeading___Toc124236922)

[Phase II Competing Renewal Awards 56](#__RefHeading___Toc124236923)

[Division of Pharmacotherapies & Medical Consequences of Drug Abuse
57](#__RefHeading___Toc124236924)

[Division of Clinical Neuroscience, Development and Behavioral Treatment
(DCNDBT) 60](#__RefHeading___Toc124236925)

[Division of Basic Neuroscience and Behavioral Research (DBNBR)
71](#__RefHeading___Toc124236926)

[Division of Epidemiology, Services and Prevention Research (DESPR)
77](#__RefHeading___Toc124236927)

[Office of Science Policy and Communications (OSPC)
81](#__RefHeading___Toc124236928)

[International Program 82](#__RefHeading___Toc124236929)

[Other Research Topic(s) Within the Mission of the Institute
82](#__RefHeading___Toc124236930)

[National Institute on Deafness and Other Communication Disorders
(NIDCD) 82](#__RefHeading___Toc124236931)

[Phase II Competing Renewal Awards 82](#__RefHeading___Toc124236932)

[Hearing Program 83](#__RefHeading___Toc124236933)

[Balance/Vestibular Program 83](#__RefHeading___Toc124236934)

[Voice, Speech, and Language Programs 84](#__RefHeading___Toc124236935)

[Taste and Smell Program 84](#__RefHeading___Toc124236936)

[Other Research Topic(s) Within the Mission of the Institute
84](#__RefHeading___Toc124236937)

[National Institute of Dental and Craniofacial Research (NIDCR)
85](#__RefHeading___Toc124236938)

[Developmental Biology and Mammalian Genetics
85](#__RefHeading___Toc124236939)

[Infectious Diseases and Immunity 85](#__RefHeading___Toc124236940)

[Epithelial Cell Regulation and Transformation
86](#__RefHeading___Toc124236941)

[Mineralized Tissue and Salivary Gland Physiology, Pharmacogenetics and
Injury 87](#__RefHeading___Toc124236942)

[Molecular and Cellular Neuroscience 87](#__RefHeading___Toc124236943)

[Biotechnology and Biomaterials 88](#__RefHeading___Toc124236944)

[Clinical, Epidemiological, and Behavioral Research
88](#__RefHeading___Toc124236945)

[Other Research Topic(s) Within the Mission of the Institute
89](#__RefHeading___Toc124236946)

[National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) 89](#__RefHeading___Toc124236947)

[Phase II Competing Renewal Awards 89](#__RefHeading___Toc124236948)

[Diabetes, Endocrinology and Metabolic Diseases
90](#__RefHeading___Toc124236949)

[Digestive Diseases and Nutrition 92](#__RefHeading___Toc124236950)

[Kidney, Urologic and Hematologic Diseases
93](#__RefHeading___Toc124236951)

[Other Research Topic(s) Within the Mission of the Institute
96](#__RefHeading___Toc124236952)

[National Institute of Environmental Health Sciences (NIEHS)
96](#__RefHeading___Toc124236953)

[Exposure Biology Program 97](#__RefHeading___Toc124236954)

[Hazardous Waste Assessment, Evaluation and Remediation Program
98](#__RefHeading___Toc124236955)

[Predictive Test Systems for Safety Evaluation Program
98](#__RefHeading___Toc124236956)

[Educational and Training Resources Program
99](#__RefHeading___Toc124236957)

[Other Topics Within the Mission of the Institute
99](#__RefHeading___Toc124236958)

[National Eye Institute (NEI) 99](#__RefHeading___Toc124236959)

[Retinal Diseases Program 99](#__RefHeading___Toc124236960)

[Corneal Diseases Program 100](#__RefHeading___Toc124236961)

[Lens and Cataract Program 100](#__RefHeading___Toc124236962)

[Glaucoma and Optic Neuropathies Program
100](#__RefHeading___Toc124236963)

[Strabismus, Amblyopia, and Visual Processing Program
100](#__RefHeading___Toc124236964)

[Visual Impairment and Blindness Program
100](#__RefHeading___Toc124236965)

[Other Research Topic(s) Within the Mission of the Institute
100](#__RefHeading___Toc124236966)

[National Institute of General Medical Sciences (NIGMS)
100](#__RefHeading___Toc124236967)

[Division of Cell Biology and Biophysics
101](#__RefHeading___Toc124236968)

[Division of Genetics and Developmental Biology
102](#__RefHeading___Toc124236969)

[Division of Pharmacology, Physiology, and Biological Chemistry
102](#__RefHeading___Toc124236970)

[Center for Bioinformatics and Computational Biology
104](#__RefHeading___Toc124236971)

[Other Research Topic(s) Within the Mission of the Institute
104](#__RefHeading___Toc124236972)

[National Heart, Lung, and Blood Institute (NHLBI)
105](#__RefHeading___Toc124236973)

[Phase II Competing Renewal Awards 105](#__RefHeading___Toc124236974)

[Heart and Vascular Diseases 106](#__RefHeading___Toc124236975)

[Lung Diseases 108](#__RefHeading___Toc124236976)

[Blood Diseases and Resources 110](#__RefHeading___Toc124236977)

[Epidemiology and Clinical Applications
111](#__RefHeading___Toc124236978)

[Other Research Topic(s) Within the Mission of the Institute
113](#__RefHeading___Toc124236979)

[National Human Genome Research Institute (NHGRI)
114](#__RefHeading___Toc124236980)

[DNA Sequencing 114](#__RefHeading___Toc124236981)

[Human Genome Sequence Variation 114](#__RefHeading___Toc124236982)

[Comparative Genomics 115](#__RefHeading___Toc124236983)

[Functional Genomics 115](#__RefHeading___Toc124236984)

[Bioinformatics and Computational Biology
115](#__RefHeading___Toc124236985)

[Bioinformatics Education 115](#__RefHeading___Toc124236986)

[Ethical, Legal and Social Implications (ELSI) of Genomics and Genetics
Research 115](#__RefHeading___Toc124236987)

[Other Research Topic(s) Within the Mission of the Institute
115](#__RefHeading___Toc124236988)

[National Institute of Mental Health (NIMH)
115](#__RefHeading___Toc124236989)

[Phase II Competing Renewal Awards 116](#__RefHeading___Toc124236990)

[Division of Neuroscience and Basic Behavioral Science
117](#__RefHeading___Toc124236991)

[The Division of Pediatric Translational Research and Treatment
Development 125](#__RefHeading___Toc124236992)

[Division of Adult Translational Research and Treatment Development
(DATR) 127](#__RefHeading___Toc124236993)

[Division of AIDS and Health and Behavior Research (DAHBR)
130](#__RefHeading___Toc124236994)

[Division of Services and Intervention Research
132](#__RefHeading___Toc124236995)

[National Institute of Neurological Disorders and Stroke (NINDS)
138](#__RefHeading___Toc124236996)

[Phase II Competing Renewal Awards 138](#__RefHeading___Toc124236997)

[Neurodevelopment 139](#__RefHeading___Toc124236998)

[Neurogenetics 139](#__RefHeading___Toc124236999)

[Repair and Plasticity 140](#__RefHeading___Toc124237000)

[Systems and Cognitive Neuroscience 141](#__RefHeading___Toc124237001)

[Channels, Synapses and Circuits 142](#__RefHeading___Toc124237002)

[Neurodegeneration 142](#__RefHeading___Toc124237003)

[Neural Environment 143](#__RefHeading___Toc124237004)

[Technology Development 144](#__RefHeading___Toc124237005)

[Other Research Topic(s) Within the Mission of the Institute
144](#__RefHeading___Toc124237006)

[National Institute of Nursing Research (NINR)
145](#__RefHeading___Toc124237007)

[Research and Development of Technologies for Health Promotion and
Alleviation, Adaptation to, or Management of Symptoms
145](#__RefHeading___Toc124237008)

[Research and Development of Technologies to Enhance Self Care and
Clinical Care 145](#__RefHeading___Toc124237009)

[Other Research Topic(s) Within the Mission of the Institute
146](#__RefHeading___Toc124237010)

[National Center for Research Resources (NCRR)
146](#__RefHeading___Toc124237011)

[Research and Development in Instrumentation and Specialized
Technologies for\
Biomedical Research 146](#__RefHeading___Toc124237012)

[Research and Development in Comparative Medicine
147](#__RefHeading___Toc124237013)

[Clinical Technology Applications 148](#__RefHeading___Toc124237014)

[Development of Discovery-Oriented Software and Tools for Science
Education 148](#__RefHeading___Toc124237015)

[Other Research Topic(s) Within the Mission of the Center
148](#__RefHeading___Toc124237016)

[National Center for Complementary and Alternative Medicine (NCCAM)
149](#__RefHeading___Toc124237017)

[Technology Development and Research 149](#__RefHeading___Toc124237018)

[Topics That Are of Little or No Interest to NCCAM
149](#__RefHeading___Toc124237019)

[Other Research Topic(s) Within the Mission of the Center
150](#__RefHeading___Toc124237020)

[National Center on Minority Health and Health Disparities (NCMHD)
150](#__RefHeading___Toc124237021)

[Natural History of Disparities in Health Outcomes
150](#__RefHeading___Toc124237022)

[Health Promotion and Prevention Research in the Health Disparities
Communities 150](#__RefHeading___Toc124237023)

[Innovations in Health Disparities Research
151](#__RefHeading___Toc124237024)

[Broad Area of Research that we Support
151](#__RefHeading___Toc124237025)

[National Library of Medicine (NLM) 151](#__RefHeading___Toc124237026)

[Biomedical Informatics 151](#__RefHeading___Toc124237027)

[Bioinformatics 152](#__RefHeading___Toc124237028)

[Other Research Topic(s) Within the Mission of NLM by pre-arrangement
with NLM\
Program Staff 152](#__RefHeading___Toc124237029)

[CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
152](#__RefHeading___Toc124237030)

[National Center on Birth Defects and Developmental Disabilities
(NCBDDD) 153](#__RefHeading___Toc124237031)

[Other Research Topic(s) Within the Mission of the Center
153](#__RefHeading___Toc124237032)

[National Center for Chronic Disease Prevention and Health Promotion
(NCCDPHP) 153](#__RefHeading___Toc124237033)

[Division of Cancer Prevention and Control
154](#__RefHeading___Toc124237034)

[Division of Adult and Community Health
155](#__RefHeading___Toc124237035)

[Division of Nutrition and Physical Activity
156](#__RefHeading___Toc124237036)

[Division of Oral Health 158](#__RefHeading___Toc124237037)

[Division of Reproductive Health 159](#__RefHeading___Toc124237038)

[National Center for Injury Prevention and Control (NCIPC)
160](#__RefHeading___Toc124237039)

[Other Research Topic(s) Within the Mission of the Center
162](#__RefHeading___Toc124237040)

[National Institute for Occupational Safety and Health (NIOSH)
162](#__RefHeading___Toc124237041)

[Other Research Topic(s) Within the Mission of the Institute
164](#__RefHeading___Toc124237042)

[FOOD AND DRUG ADMINISTRATION (FDA) 165](#__RefHeading___Toc124237043)

[Center for Biologics Evaluation and Research (CBER)
165](#__RefHeading___Toc124237044)

[Center for Drug Evaluation and Research (CDER)
166](#__RefHeading___Toc124237045)

[Center for Food Safety and Applied Nutrition (CFSAN)
167](#__RefHeading___Toc124237046)

[Center for Devices and Radiological Health (CDRH)
167](#__RefHeading___Toc124237047)

[Center for Veterinary Medicine (CVM) 168](#__RefHeading___Toc124237048)

[Office of Orphan Products Development
168](#__RefHeading___Toc124237049)

[Other Research Topic(s) Within the Mission of FDA
168](#__RefHeading___Toc124237050)

Funding Opportunity Announcements, Application Instructions, and
Appendices are contained in separate files. Follow the links below to
view these documents.

Funding Opportunity Announcements

Small Business Innovation Research Program Parent Announcement (SBIR
\[R43/R44\])
[[http://grants.nih.gov/grants/guide/pa-files/PA-06-120.html]{.smallcaps}](http://grants.nih.gov/grants/guide/pa-files/PA-06-120.html)

Small Business Technology Transfer Program Parent Announcement (STTR
\[R41/R42\])
[[http://grants.nih.gov/grants/guide/pa-files/PA-06-121.html]{.smallcaps}](http://grants.nih.gov/grants/guide/pa-files/PA-06-121.html)

Additional Special Announcements for Small Business Research
Opportunities
[[http://grants.nih.gov/grants/funding/sbir_announcements.htm]{.smallcaps}](http://grants.nih.gov/grants/funding/sbir_announcements.htm)

Application Instructions

Application Instructions
(<http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_SBIR_STTR.doc>)

SF424 (R&R) Application and Electronic Submission Information
(<http://grants.nih.gov/grants/funding/424/index.htm>)

Appendices

STTR Model Agreement ([MS
Word](http://grants.nih.gov/grants/funding/sbirsttr1/STTRmodelagreement.doc))

Extramural Invention Reporting Compliance Responsibilties
([PDF](http://grants.nih.gov/grants/funding/sbirsttr1/IEdison.pdf))

NIH SBIR/STTR Internet Guide ([MS
Word](http://grants.nih.gov/grants/funding/sbirsttr_sites.doc))

#   {#section .unnumbered}

# Program Descriptions and Research GRANT Topics

The research topics shown in this solicitation represent program areas
that may be of interest to applicant small business concerns in the
development of projects that have potential for commercialization. Small
business concerns are encouraged to submit SBIR/STTR grant applications
in these areas.

APPLICABLE TO NIH ONLY: SBIR and STTR grant applications will be
accepted and considered in any area within the mission of the awarding
components identified in this solicitation.

Applicants are strongly encouraged to query program administrators
periodically via email to learn of new or emerging scientific interests
of the NIH, CDC, and FDA awarding components.

Additional information on each of the awarding components and their
research interests is available electronically on the home pages shown
throughout the "Research Topics" section of the solicitation.

The Fogarty International Center, which provides support only for
conferences, postdoctoral fellowships for research in the United States
and abroad, and senior scientist exchanges between the United States and
other countries, does not participate in the SBIR/STTR program.

[]{#__RefHeading___Toc124236865 .anchor}National Institutes of Health
(NIH)

The mission of the NIH is to improve human health through biomedical and
behavioral research, research training, and communications. The programs
of the NIH are oriented principally towards basic and applied scientific
inquiry related to the causes, diagnosis, prevention, treatment, and
rehabilitation of human diseases and disabilities; the fundamental
biological processes of growth, development, and aging; and the
biological effects of the environment. In addition, the NIH sponsors
training of research personnel; career development of new and
established scientists; evaluation and dissemination of new information
about medicine and health; construction and renovation of research
facilities and provision of other research resources; and improvements
in biomedical communications.

To carry out these responsibilities, the NIH is organized into awarding
components (Institutes/Centers). Those components that have an
extramural element, that is, provide funds for research and research
training activities in organizations external to the NIH, are shown
below. The NIH makes every effort to finance worthy proposals, including
the co-funding of such proposals by one or more awarding components
having relevance in the projects.

[]{#__RefHeading___Toc124236866 .anchor}Trans-NIH Research Programs

[]{#__RefHeading___Toc124236867 .anchor}Phase II Competing Renewal
Awards

Some NIH Institutes/Centers (ICs) now offer Phase II SBIR/STTR awardees
the opportunity to apply for a Phase II Competing Renewal award. Some
ICs have announced this opportunity through the NIH Guide for Grants and
Contracts (see list below), and some are using this Omnibus SBIR/STTR
Grant Solicitation. Only those small business concerns who have been
awarded a Phase II are eligible to apply for a Phase II Competing
Renewal award. Moreover, this opportunity is only for Phase II awardees
that propose to continue the process of assessing and improving drugs or
devices or propose to conduct preclinical studies of drugs or devices
that ultimately require: 1) clinical evaluation, 2) approval of a
Federal regulatory agency, and/or 3) continuing refinements to durable
medical equipment (DME) designs such as cost reduction, testing for
safety, durability, and reliability, and meeting or establishing
standards. Such products include, but are not limited to, devices,
drugs, vaccines, therapeutics, and medical implants related to the
mission of the IC. The product being developed must be one for which
Federal regulatory approval (e.g., FDA) is a required step toward
commercialization. Prospective applicants are strongly encouraged to
contact NIH staff prior to submission of a Competing Renewal
application. Additional requirements and instructions (e.g., submission
of a letter of intent) are available in the specific IC research topics
section and in the specific [IC Program
Announcements](http://grants.nih.gov/grants/funding/sbir_announcements.htm)
(<http://grants.nih.gov/grants/funding/sbir_announcements.htm>). The
following NIH ICs will accept applications for Phase II Competing
Renewal awards: **NIAAA, NIA, NIAID**, **NICHD, NIDA** (SBIR only),
**NIMH** (SBIR only), **NHLBI** (SBIR only and only Competing Renewals
of NHLBI-supported Phase II awards), **NIDCD, NIDDK, and NINDS.**

[]{#__RefHeading___Toc124236868 .anchor}Bioengineering Nanotechnology
Initiative

See Program Announcement at
[http://grants.nih.gov/grants/guide/pa-files/\
PA-06-009.html](http://grants.nih.gov/grants/guide/pa-files/%0BPA-06-009.html)
(SBIR) and <http://grants.nih.gov/grants/guide/pa-files/PA-06-008.html>
(STTR)

The NIH invites grant applications for 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.

The following list describes some of the priority areas for nanoscience
and nanotechnology research support at NIH. The 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.

-   Nanomaterials (enabling): development of synthetic nanoscale
    building blocks for the formulation of bottom-up approaches to
    complex and multi-functional nano materials. These materials are
    expected to find use in applications towards pharmaceutical
    delivery, towards the development of contrast and biological agents,
    and multi-functional medical devices.

-   Nano-bio interfaces: science of controlling the interface between
    biomolecular systems and nanoscale synthetic materials, which
    involves ability to control the interface architecture and
    transduction of the control signal through this interface.

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

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

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

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

-   Environmental and health impact of nanotechnologies: ramifications
    of nanomaterial processing, use, and degradation on health and the
    environment.

-   In-vivo therapeutics: development of nanoparticles that enable
    controlled release of therapeutic agents, antibodies, genes and
    vaccines into targeted cells.

-   Sensor technologies: 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.

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

-   Bioinformatics for nanotechnology: algorithms and computer software
    to enable and support all of the above.

[]{#__RefHeading___Toc124236869 .anchor}Manufacturing Processes of
Medical, Dental, and Biological Technologies (STTR \[R41/R42\])

<http://grants.nih.gov/grants/guide/pa-files/PA-06-012.html> (SBIR) and
<http://grants.nih.gov/grants/guide/pa-files/PA-06-013.html> (STTR)

The NIH encourages 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.

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.

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.

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.

Technology for the manufacture of research instrumentation, such as
highly sensitive, high resolution spectrometers, highly selective
electrodes, microarray devices, and microfluidic devices.

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.

Technology for the manufacture and delivery of therapeutic drugs,
including for example, synthetic process chemistry, separations methods,
formulation, and dosage delivery.

Technology for the manufacture of implantable devices and materials,
including drug delivery pumps, prosthetic organs, artificial tissues,
electronic sensors and electrical stimulators.

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.

Technology for the production and isolation of biotechnology products,
such as proteins, antibodies, nucleic acids, vaccines, and vectors for
genetic engineering and gene therapy. 

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.

Technology for manufacture of medical device power sources, such as high
energy density, long life-time batteries, solar cells, and fuel cells.

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.

Rapid prototyping and manufacture technology suitable for remote site
and on demand production processes.

Technology to promote the recovery, reuse, and remanufacture (recycling)
of medical materials and equipment.

Technology for the manufacture of biomedically specialized computational
and information technology equipment and software.

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>.)

[]{#__RefHeading___Toc124236870 .anchor}Development of Synthetic and
Natural Biomaterial Reference Materials

The NIH invites applications for the development of synthetic or natural
biomaterial reference materials (RMs). RMs are used for standardization
of studies of interactions between materials and blood and tissues, for
calibration of physicochemical test methods, and/or for reference
controls in physical, chemical, and materials structure characterization
tests. All innovative developments of biomaterials and devices also need
measurements to demonstrate their innovation and improvement. Because
RMs lie at the heart of measurement technology, funding for their
development could play a key role in future advances in biomaterials and
biomedical material device technologies.

Industry uses biomaterial RMs for quality assurance and traceability.
The Food and Drug Administration considers them useful for comparing new
biomaterials, or new uses of biomaterials, with existing standards and
materials. In order to have maximum utilitarian value, it is intended
that these biomaterial RMs be stored at, and distributed by, the
National Institute of Standards and Technology (NIST). Hence, they must
be produced to meet the stringent requirements of the NIST Standard
Reference Material Program. *[It is important for applicants to contact
NIST (Dr. John A. Tesk, (301) 975-6799; Email: john.tesk@nist.gov) to
obtain detailed information on requirements of that program prior to
preparing and submitting their applications.]{.underline}*

Biomaterial RMs may be synthetic polymers, ceramics, metals, or mixtures
of these, or may be derived from living tissues. The choice of RM to be
developed is up to the applicant but must be fully justified based on
the applicant's knowledge of the magnitude of the current or potential
utilization of the biomaterial. RMs of known particular value include:
(1) silica-filled poly(dimethylsiloxane), (2) aliphatic polyether
urethane, (3) poly (vinylchloride), (4) poly(methylmethacrylate), (5)
expanded poly (tetrafluoroethylene) of varying standardized internodal
distances, (6) oxygen permeability standards, and (7) carbon materials
used in mechanical heart valve designs.

RMs must be of appropriate size and shape. The form in which the
reference material is produced and the tests necessary to characterize
the material are the decision of the applicant based on the end use of
the material. The applicant may consider NIST as a potential
subcontractor for measurement and other professional services.

For additional information on this topic, please contact:

Bishow B. Adhikari, Ph.D.

Health Scientist Administrator

Bioengineering and Genomic Applications, SRG

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 9140, MSC 7940

Bethesda, MD 20892-7940

(For express mail, zip code 20817)

\(301\) 301-435-0513; Fax: (301) 480-1335

Email: <adhikarb@mail.nih.gov>

[]{#__RefHeading___Toc124236871 .anchor}National Center on Sleep
Disorders Research

The National Center on Sleep Disorders Research (NCSDR) was established
within the National Heart, Lung, and Blood Institute (NHLBI) as a result
of the National Institutes of Health (NIH) Revitalization Act of 1993.
Its mandate is to conduct and support research, training, health
information dissemination, and other activities with respect to sleep
disorders, including biological and circadian rhythm research, basic
understanding of sleep, chronobiological and other sleep related
research and to coordinate the activities of the Center with similar
activities of other Federal agencies, including the other agencies of
the National Institutes of Health, and similar activities of other
public entities and nonprofit entities.

Three specific types of research are emphasized: basic research using
state-of-the-art approaches to elucidate the functions of sleep and the
fundamental molecular and cellular processes underlying sleep;
patient-oriented research to improve the diagnosis and treatment of
sleep disorders; and applied research to evaluate the scope and health
consequences of sleepiness and sleep disorders.

Research opportunities of potential interest to small businesses may
include, but are not limited to the following examples:

A. Portable instrumentation for diagnostic in-home assessment of sleep
disorders especially sleep disordered breathing.

B. Countermeasures for excessive daytime sleepiness, including methods
that alter the output of the circadian clock to optimize sleep and
wakefulness.

C. New technologies and instrumentation scaled for high-throughput
phenotypic characterization of sleep in mice.

D. High volume, inexpensive assays to assess variations in gene
expression related to circadian and behavioral state (sleep and
wakefulness) related .

E. Improved methods for the diagnosis of sleep disordered breathing in
infants, children, and adults.

F. Educational interventions to improve worksite productivity and school
performance through the prevention and management of insufficient sleep
and poor sleep environment conditions.

G. Portable inexpensive devices for ambulatory assessment of both sleep
and physical activity in population-based biomedical research studies.

H. Methods to improve patient compliance with sleep disordered breathing
treatments.

I. New pharmacological for the treatment of sleep disorders, especially
sleep disordered breathing.

J. Noninvasive imaging technologies to assess neurophysiological and
regional brain blood flow changes associated with sleep disorders and
other causes of excessive daytime sleepiness.

For additional information on research topics, please see the National
Sleep Disorders Research Plan
(<http://www.nhlbi.nih.gov/health/prof/sleep/res_plan/index.html>) and
contact:

Mr. Al Golden, MPH

Public Health Advisor

National Center on Sleep Disorders Research

NHLBI, 6701 Rockledge Drive

Bethesda, MD 20892

\(301\) 435-0199; Fax: (301) 480-3451

Email: <goldena@nhlbi.nih.gov>

[]{#__RefHeading___Toc124236872 .anchor}National Institute on Aging
(NIA)

The NIA supports biomedical, behavioral, and social research and
research training on the aging process as well as on the diseases and
other special problems and needs of older people. It supports grant
research under four established programs: Biology of Aging, Behavioral
and Social Research, Neuroscience and Neuropsychology of Aging, and
Geriatrics and Clinical Gerontology.

Examples of research topics within the mission of the NIA that may be of
interest to small businesses are shown below. These listings illustrate
the range of areas that are of interest to the NIA and are not intended
to be exhaustive.

For additional information about areas of interest to the NIA, please
visit our home page at
[http://www.nia.nih.gov](http://www.nia.nih.gov/).

[]{#__RefHeading___Toc124236877 .anchor}Phase II Competing Renewal
Awards

NIA will accept Phase II Competing Renewal grant applications from Phase
II SBIR/STTR awardees to continue the process of developing products
that require approval of a Federal regulatory agency (e.g., FDA). Such
products include, but are not limited to: medical implants, drugs,
vaccines, and new treatment or diagnostic tools that require FDA
approval.

NIA will accept applications for up to two (2) years and up to \$750,000
per year in total costs. This renewal grant should allow small
businesses to get to a stage where interest and investment by third
parties is more likely.

Please contact Dr. Michael-David A.R.R. Kerns (see contact information
below) before beginning any work on a Competing Renewal application.
Potential applicants must obtain approval from NIA before submitting a
Competing Renewal application. After obtaining approval from NIA,
prospective applicants are requested to submit a letter of intent that
includes the following information:

-   Descriptive title of the proposed research

-   Name, address, and telephone number of the Principal Investigator

-   Names of other key personnel

-   Participating institutions

-   Funding Opportunity Announcement Number (e.g., PA-06-XXX)

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 NIH staff to estimate the potential review
workload and plan the review. It is expected that only a portion of NIA
SBIR/STTR Phase II awards will be eligible for a Competing Renewal
grant.

The following examples would make appropriate topics for proposed SBIR
or STTR Phase II Competing Renewal projects. These are meant for
illustrative purposes only and are not exclusive of other appropriate
activities. Research and development efforts can be focused on
medications to treat, delay the progression of, or prevent age-related
cognitive decline, Alzheimer's disease, and other dementias of aging.

1\. Studies for preclinical discovery and development of drugs, natural
products, or other types of compounds, including pharmacology and
toxicology studies, beyond those conducted under the initial SBIR Phase
I and Phase II grants. The studies conducted under the previous grants
should be sufficient to provide a sound rationale for continued
development of the drug or natural product.

2\. Completion of studies as required by the FDA for an IND application.

3\. Human clinical trials/studies to determine a drug's, natural
product's, or other type of compound's safety profile, metabolism,
and/or efficacy.

For questions relating to Phase II Competing Renewal applications,
please contact:

Dr. Michael-David (MD) A.R.R. Kerns

\(301\) 402-7713, Fax: (301) 402-2945

Email: kernsmd@mail.nih.gov

[]{#__RefHeading___Toc124236873 .anchor}Behavioral and Social Research

Research on basic and translational social and behavioral research on
aging processes and the place of older people in society. The program
focuses on how people change with age, on the interrelationships between
older people and social institutions (e.g., the family, health-care
systems), and on the societal impact of the changing age-composition of
the population. Emphasis is placed upon the dynamic interplay between
the aging of individuals and their changing social and physical
environments. Special emphasis areas are Aging Minds (see *The Aging
Mind: Opportunities in Cognitive Research*,
[http://books.nap.edu/catalog/
9783.html](http://books.nap.edu/catalog/9783.html)); Genetics, Behavior
and the Social Environment; Health Disparities; Health, Work and
Retirement; Increasing Health Expectancy; and Interventions and Behavior
Change. Areas that may be of interest to small businesses include, but
are not limited to:

A. Cognitive and human factors interventions on the individual and
environment to maintain independence, maintain functioning, increase
well being, and prevent disease/disability. Such interventions can
include behavioral technologies, environmental modifications and
redesign, training and teaching efforts, or new programs, products and
services. Interventions can be developed for home, community,
health-care or work-place settings.

B. Research Innovation: Innovations and new products that improve data
collection, data analysis, and data dissemination are encouraged.
Examples of areas of interest in data collection include, but are not
limited to: experience sampling methodologies; improved
performance-oriented measures of cognitive and physical functioning
suitable for use in field settings or in cross-national research; the
development of miniaturization devices to improve real-time data
collection, and the development of computer-assisted personal and
telephone instrument modules to use with older respondents. New and
innovative methods for improving the measurement of well-being in the
older populations (both across subgroups and internationally), are
particularly encouraged.

C. Social, behavioral, environmental and/or technical interventions on
the individual for health maintenance and disease/disability prevention.
Such interventions can include self management of chronic diseases
including behavioral change technologies, enhancing compliance,
especially for less educated patients with chronic diseases requiring
strict adherence to complex regimens, or new programs, products and
services to increase the health, functioning and well-being of older
people. Interventions can be developed for home, community, health-care
or work-place settings.

D. AIDS and aging. The development of intervention strategies which are
designed to prevent the spread of AIDS in middle-aged and older
populations. These strategies may include health education programs to
inform the health care providers and public about risks of AIDS in older
people.

E. Multi-Level Interventions are interventions that influence multiple
levels. Levels include the social, community, family, institutional, and
individual. More information about the use of multilevel methodology in
the social sciences can be found in [People and Pixels: Linking Remote
Sensing and Social Science
(]{.underline}<http://books.nap.edu/openbook/0309064082/html/index.html>[)]{.underline}.
Other valuable information about social science interventions can be
obtained from [New Horizons in Health an Integrative Approach
(]{.underline}[http://books.nap.edu
/openbook/0309072964/html/index.html](http://books.nap.edu/openbook/0309072964/html/index.html)[)]{.underline}.
Interventions and technologies that address multiple levels are of
particular interest to the Behavior and Social Research Program.

Dr. Elayne Heisler

\(301\) 496-3138, Fax: (301) 402-0051

Email: <heislere@nia.nih.gov>

F. Interventions for care provision. Development of strategies for care
providers (both professionals and families) to deal with burdens of care
associated with chronic disabling illness or disease (including
Alzheimer\'s disease). Interventions include new forms of adult day
care, and family interventions. Development of work site programs to
supply information on caregiving (including community respite and
daycare facilities) and to enable advance planning by employees.

G. Death and dying. Programs that deal with decreasing the trauma and
difficulty of elders, their families, and care providers faced with
end-of-life decisions and those events that surround the end of life.

H. Long-term adherence. Development of strategies and technologies to
enhance long-term adherence to medical regimes for chronic conditions
and behavior-change interventions for health promotion in older adults.
Adherence advances might target the healthcare provider, caregiver or
patient, or a larger group, such as a social network.

Dr. Sidney M. Stahl

\(301\) 402-4156, Fax: (301) 402-0051

Email: <StahlS@nia.nih.gov>

I. Forecasting. Development of mathematical, economic, demographic and
epidemiological models that will lead to improved forecasting of
national, state and county level estimates of the demand for
aging-related services and improved prediction of the effects of public
health interventions, changes in health-care financing and insurance,
social security, pension coverage or changes in the retirement age. For
example, micro- and macro-simulation models of changes in health and
economic status and methodological enhancements to existing models that
takes into account health, intergenerational transfers, changes in
family composition, and other characteristics of future cohorts. The
program is interested in both domestic and international projections.

J. Measurement instruments and database support. The program supports
collection of numerous large datasets and is therefore interested in
technologies which lead to products that will facilitate distribution of
data while ensuring the confidentiality of NIA supported longitudinal
studies are of particular interest. Information on supported datasets
can be found at: [http://www.nia.nih.gov/research/
extramural/behavior/datasets.pdf](http://www.nia.nih.gov/research/extramural/behavior/datasets.pdf).

1\. Development of new instruments using existing demographic and
economic data and theory that yield defensible estimates of quality of
health plans, hospitals, nursing homes, etc. The program is interested
in both domestic and international estimates.

2\. Development of improved performance-oriented measures of cognitive
and physical functioning suitable for use in field settings or in
cross-national research.

3\. Development of new technologies which improve large scale
longitudinal surveys in the US and abroad. Including the development of
computer-assisted personal and telephone instrument modules, including
expert systems, to use with older respondents, in order to determine
information such as occupational status, migration, housing issues,
disability status, and family structure.

4\. Development of new databases (e.g., from administrative data) and
database support to satisfy data and research needs on aging, and
innovative data archives and methods for accessing archives to make
current statistical and epidemiological data more accessible to
researchers.

5\. Development of innovative methods and software to provide improved
high performance remote analytic access to complex longitudinal studies
or surveys that cannot be placed in open data archives because of issues
relating to confidentiality and the need to prevent re-identification of
subjects or respondents. Such software would increase the ease with
which data analysts could perform sophisticated analyses with a wide
range of statistical software programs, while automatically preventing
any analyses or remote requests that could compromise data security.

6\. The development of high quality micro or macro simulations models
that measure the impact of interventions on health expenditures,
well-being and other outcomes.

K. Dissemination and teaching materials. Development of innovative
teaching and dissemination tools (e.g., dataset-based computer programs,
simulations/games, videotapes and other heuristic devices) to teach
dynamics of population aging and convey results of aging research. For
example, teaching modules for secondary data analysis for high school
and college students using, for example, data from the US Census Bureau,
the National Center for Health Statistics, or an NIA sponsored study
(see NIA website
<http://www.nia.nih.gov/research/extramural/behavior/datasets.pdf> for
available data sets) and projection data.

L. Interventions on the health-care system. Development and evaluation
of strategies to improve health-care organization and delivery including
attention to assisted living and new forms of in-home care.

Ms. Georgeanne Patmios, MA

\(301\) 496-3138, Fax: (301) 402-0051

Email: <PatmiosG@nia.nih.gov>

M. Development of indicators and measures of progress in the behavioral
and social sciences, including bibliometric measures of citations and
impact of research, measures of the rate of change and the formation of
new research areas, and measures of the impact of behavioral and social
research on public policy and well-being.

Dr. Richard Suzman

\(301\) 496-3131, Fax: (301) 402-0051

Email: [[SuzmanR@nia.nih.gov]{.underline}](mailto:SuzmanR@nia.nih.gov)

N. Development of miniaturized devices to be used in behavioral and
social research to improve real-time, remote monitoring, virtual data
collection for instant, continuous, and/or interactive feedback system,
and reliable data storage/retrieval.

Ms. Angie Chon-Lee, MPH

\(301\) 594-5943, Fax: (301) 402-0051

Email: <Chon-LeA@nia.nih.gov>

[]{#__RefHeading___Toc124236874 .anchor}Biology of Aging

Research on the physiology, molecular, and cellular basis of aging
processes. NIA also has responsibility for maintaining existing
resources and developing new resources for aging research, such as
populations of well-characterized animals and specific cell lines, for
example, human fetal lung fibroblasts. Areas that may be of interest to
small businesses include, but are not limited to:

A. Effects of metabolism on the aging process, e.g., how metabolic
regulation influences longevity, and the development of anti-oxidant
interventions to reduce oxidative stress in vivo.

Dr. David Finkelstein

\(301\) 496-6402, Fax: (301) 402-0010

Email: <df18s@nih.gov>

B. Development of minimally-perturbing techniques for collecting blood
from mice, rats, and other animals several times a day in sufficient
quantities for measurement of hormone levels and other circulating
factors in young and old animals, or development of non-invasive
research and test methods for use in animals.

Dr. Nancy Nadon

\(301\) 496-6402, Fax: (301) 402-0010

Email: <nn37a@nih.gov>

C. Development of molecular probes such as antibodies, DNA sequences and
expression vectors useful in studying aging, senescence, and longevity
both in vivo and in vitro.

Dr. Anna McCormick

\(301\) 496-6402, Fax: (301) 402-0010

Email: <am38k@nih.gov>

or

Dr. Rebecca Fuldner

\(301\) 496-6402, Fax: (301) 402-0010

Email: <Fuldnerr@mail.nih.gov>

D. Instruments and/or methodology to monitor dynamic progression of
ovarian follicles from primordial through antral stages in humans and
other mammals with sufficient sensitivity to obtain an accurate profile
during the perimenopausal period when relatively small numbers of
follicles are present.

Dr. Frank Bellino

\(301\) 496-6402, Fax: (301) 402-0010

Email: <fb12a@nih.gov>

E. Development of new animal models, including transgenic animals, for
studying aging processes, as well as development of new biological model
systems for research on aging to replace or reduce vertebrate animal use
in research. These models may include better in vitro systems, improved
cell culture methods, mathematical models, and computer simulations.

Dr. Nancy Nadon

\(301\) 496-6402, Fax: (301) 402-0010

Email: <nn37a@nih.gov>

F. Development of interventions to slow down the degenerative processes
associated with aging. These would include techniques with commercial
potential to: (1) manipulate the control of cell proliferation or
programmed cell death, (2) reduce the level of damage to nucleic acids,
proteins and lipids and the macromolecular complexes formed from these
molecules, (3) improve the damage surveillance and repair potential of
cells, (4) improve the immune response to foreign molecules or reduce
the response to self, and (5) reverse age-related changes in hormone
production and function.

Dr. Nancy Nadon

\(301\) 496-6402, Fax: (301) 402-0010

Email: <nn37a@nih.gov>

G. Development of treatments for wound healing in the aged.

Dr. Jill Carrington

\(301\) 496-6402, Fax: (301) 402-0010

Email: <carringtonj@nia.nih.gov>

H. Development of appropriate animal and human culture model systems to
explore underlying molecular and cellular mechanisms of prostate growth
in middle-aged and older subjects.

I. Development of appropriate animal model systems to explore underlying
molecular and cellular model systems of female reproductive aging
processes as well as the development of pathophysiologic processes
associated with the human menopause, including bone loss, cardiovascular
pathology, hot flashes, and excessive uterine bleeding.

Dr. Frank Bellino

\(301\) 496-6402, Fax: (301) 402-0010

Email: <fb12a@nih.gov>

[]{#__RefHeading___Toc124236875 .anchor}Neuroscience and Neuropsychology
of Aging

Research on age-related changes in the brain or nervous system in the
context of other age-related physiological or homeostatic regulator
changes (e.g., endocrine, dietary, immune, disease states); degenerative
processes or pathological changes in the aging brain in the context of
understanding normal age-related changes; and the sensory, perceptual
and cognitive processes and changes that occur with aging as related to
their underlying biological mechanisms. An important component of this
program is the support of studies on Alzheimer\'s disease and related
dementias of aging. Areas that may be of interest to small businesses
include, but are not limited to:

A. Devices or intervention strategies that may prolong independence when
there are dysfunctions of the central nervous system.

B. Development of sensitive, specific and standardized tests for
diagnostic screening of cognitive decline and dementia, for example, the
development of biochemical and neuroimaging criteria for the diagnosis
of cognitive decline and Alzheimer\'s disease.

C. Discovery, development and/or evaluation of drugs, delivery systems,
or treatments to enhance cognitive functioning in normal aging and to
treat the cognitive deterioration and/or behavioral symptoms associated
with Alzheimer\'s disease as well as to slow and/or reverse the course
of the disease, or prevent it entirely.

Dr. Neil Buckholtz

\(301\) 496-9350, Fax: (301) 496-1494

Email: <nb12s@nih.gov>

D. Nutritional interventions to restore brain biochemical changes in
aging and neurodegenerative diseases.

E. Biosensors and prosthetic devices to aid sensory and memory
dysfunctions.

Dr. Judith Finkelstein

\(301\) 496-9350, Fax: (301) 496-1494

Email: <jf119k@nih.gov>

F. New technologies to screen for the presence of sleep disorders in
older persons, to aid in the diagnosis of these disorders, and to enable
their remediation.

Dr. Andrew Monjan

\(301\) 496-9350, Fax: (301) 496-1494

Email: <am39m@nih.gov>

G. Improved instrumentation, imaging technology, related devices, and
software packages for use in visualizing neural activity during
cognitive or sensory behavior in older adults. Also of interest would be
new technologies to combine neural imaging and behavioral assessment in
awake unanesthetized animals.

Dr. Molly Wagster

\(301\) 496-9350, Fax: (301)496-1494

Email: <mw203d@nih.gov>

H. Development of technology and analysis tools to examine cellular
patterns of gene and protein expression in the normal and diseased aging
nervous system, including the identification of aberrant gene products
expressed in the aging brain. Development of molecular imaging
technology for the in vitro and in vivo analysis of gene and protein
function in the normal aging brain and in the diseased aging nervous
system.

I. Development of technology such as non-invasive methods, to identify
neural stem cells and to monitor their function in the adult and aged
nervous system Development of novel markers of stem cell proliferation,
migration, and differentiation, as well as methods to assess the
integration and function of stem cells in the nervous system.

Dr. Brad Wise (normal brain aging)

\(301\) 496-9350, Fax: (301) 496-1494

Email: <bw86y@nih.gov>

Dr. D. Stephen Snyder (Alzheimer\'s disease and other dementias of
aging)

\(301\) 496-9350

Email: <ss82f@nih.gov>

[]{#__RefHeading___Toc124236876 .anchor}Geriatrics and Clinical
Gerontology

The Geriatrics and Clinical Gerontology (GCG) Program supports research
on health and disease in the aged and research on aging over the human
life span and its relationships to health outcomes. Research on
Geriatrics focuses primarily on health issues regarding the aged, and
deals with research on disease and disability in older persons,
including both specific conditions and issues related to multiple
morbidity. Clinical Gerontology Research focuses primarily on clinically
related issues regarding aging, and deals with research on aging changes
over the life span. A major focus is on the determinants of rates of
progression of age-related changes that affect disease risk,
particularly those affecting risk for multiple age-related conditions.

Areas of interest include but are not limited to:

A. Research on better ways to prevent injuries and deaths associated
with the use of currently available bed rails in older patients; this
will include improved designs of bed systems for use in the home,
nursing home and hospital.

B. Development of vaccines and other agents for preventing and treating
infections in older persons, including development of new vaccines or
preventive interventions, and new methods using currently available
vaccines or preventive medications.

C. Techniques for preventing or treating urinary incontinence.

Dr. Susan Nayfield

\(301\) 496-6761, Fax: (301) 402-1784

Email: <nayfiels@nia.nih.gov>

D. Refinements in techniques for the measurement of age-related changes
in hormone levels, status or pharmacokinetics (e.g., those of growth
hormone, IGF-1 and its binding proteins; estrogen, progesterone,
testosterone; other markers of ovarian, testicular, hypothalamic and
pituitary function). The objective is to enhance sensitivity and achieve
greater economy in the assay cost.

E. Effects of menopause on woman\'s aging and subsequent health. Effects
of age-related changes in endocrine status in men on subsequent aging,
morbidity and mortality.

1\. Refinements in techniques for the measurement of age-related changes
in hormone levels or pharmacokinetics (e.g., those of growth hormone,
IGF-1 and its binding proteins; estrogen, progesterone, testosterone;
other markers of ovarian, testicular, hypothalamic and pituitary
function).

2 Development and testing of alternative strategies (to conventional
estrogen/ progestin therapy) for the management of short-term menopausal
symptoms and for the reduction in risks of cardiovascular disease,
osteoporosis, and other menopause-related conditions, disorders and
diseases. Development and testing of new tissue-specific modulators of
estrogen/ androgen receptor activity in men and in women for the
prevention or treatment of age-related diseases.

3\. Development, testing and validation of new surrogate measures of
clinically relevant outcomes and endpoints (e.g., fractures) for (1)
more immediate and accurate assessment of the risk or progression of
age-related diseases (e.g., osteoporosis) or (2) to predict or monitor
efficacy of treatment or enhanced risk or progression of adverse
effects/events.

4\. Determine drug interactions, i.e., potential alterations in
pharmacokinetics and pharmacodynamic properties of drugs taken
concomitantly with postmenopausal hormones.

F. Osteoporosis. Development, testing and validation of new surrogate
measures of clinically relevant outcomes and endpoints (e.g., fractures)
for (1) more immediate and accurate assessment of the risk or
progression of age-related diseases (e.g., osteoporosis) or (2) to
predict or monitor efficacy, response to treatment or enhanced risk or
progression of adverse effects/events.

Dr. Sherry Sherman

\(301\) 435-3048, Fax: (301) 402-1784

Email: <ss80t@nih.gov>

G. Improved instrumentation (e.g., accelerometers) for assessment of
physical activity, and improved monitors for visually and/or
biomechanically characterizing falls in older patients.

H. Improved instrumentation and imaging techniques for measuring body
composition and properties such as muscle function in older persons.

I. Development and validation of non-invasive methods of examining bone
quality (density, architecture, and strength of bone).

J. Development of techniques/devices (e.g., non-invasive, portable) for
improved monitoring of caloric intake and/or energy expenditure in
epidemiological studies.

K. Measurement of deficits in muscle strength and balance among older
persons.

1\. Instrumentation for biomechanical assessment of ambulation and
falls.

2\. Quantitative methods of assessing postural perturbations relevant to
activities of daily living.

Dr. Chhanda Dutta

\(301\) 435-3048, Fax: (301) 402-1784

Email: <cd23z@nih.gov>

L. Techniques and methods for screening, diagnosis, and treatment of
cancer in older persons.

1\. Development of geriatric assessment instruments and/or methodology
to assist oncologists in patient evaluation and diagnostic work-up to
determine the older patient\'s overall physical and physiologic health
status.

2\. Techniques to promote effective pain management in older-aged cancer
patients. This includes documentation and assessment of pain intensity
and its characteristics prior to and after pharmacologic and
non-pharmacologic interventions.

3\. Development of innovative teaching tools for physicians, nurses, and
other health professionals in the following areas: (1) to convey
benefits of screening and early detection of cancer for use with
older-aged persons; (2) to assist in teaching older-aged patients in
self-examination for early warning signs of cancer; and (3) to teach
older aged patients how to care for themselves after cancer surgery
(e.g., ostomy patients).

4\. Development of methods to be used as guidance for physicians to
estimate proper medication dosage in elderly cancer patients given body
composition, size, age, other health problems, kidney functioning, and
other physiologic parameters. This includes estimates of an initial or
loading dose of therapeutic drugs and daily maintenance for continuance
of therapeutic concentration of drugs in the patient\'s bloodstream.

Dr. Rosemary Yancik

\(301\) 496-5278, Fax: (301) 402-1784

Email: <ry3e@nih.gov>

M. Development of devices and techniques for screening substantial
numbers of individuals for particular alleles at loci of relevance to
human genetic studies of aging.

N. Development and validation of imaging and sensor technologies to
improve measures of physiologic changes with age.

Winifred Rossi, M.A.

\(301\) 496-3836, Fax: (301) 402-1784

Email: <wr33a@nih.gov>

[]{#__RefHeading___Toc124236878 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Dr. Michael-David ("MD") A.R.R. Kerns

National Institute on Aging

Gateway Building, Suite 2C218

7201 Wisconsin Ave., MSC 9205

Bethesda, MD 20892-9205

\(301\) 402-7713, Fax: (301) 402-2945

Email: <mk417e@nih.gov>

For administrative and budget management questions, contact:

Ms. Linda Whipp

Grants Management Officer

National Institute on Aging

Gateway Building, Room 2N212

7201 Wisconsin Ave., MSC 9205

Bethesda, MD 20892

\(301\) 496-1472, Fax: (301) 402-3672

Email: <lw17m@nih.gov>

[]{#__RefHeading___Toc124236879 .anchor}National Institute on Alcohol
Abuse and Alcoholism (NIAAA)

The NIAAA supports research on the causes, prevention, control, and
treatment of the major health problems of alcohol abuse, alcoholism, and
alcohol-related problems. Through its extramural research programs, the
NIAAA funds a wide range of basic and applied research to develop new
and/or improved technologies and approaches for increasing the
effectiveness of diagnosis, treatment, and prevention. The NIAAA also is
concerned with strengthening research dissemination, scientific
communications, public education, and data collection activities in the
areas of its research programs.

For additional information about areas of interest to the NIAAA, you are
invited to visit our home page at
[http://www.niaaa.nih.gov](http://www.niaaa.nih.gov/).

[]{#__RefHeading___Toc124236880 .anchor}Phase II Competing Renewal
Awards

NIAAA will accept Phase II SBIR/STTR Competing Renewal grant
applications to continue the process of developing products that require
approval of a Federal regulatory agency (e.g., FDA, FCC). Such products
include, but are not limited to: medical implants, drugs, vaccines, and
new treatment or diagnostic tools that require FDA approval. This
renewal grant should allow small businesses to get to a stage where
interest and investment by third parties is more likely.

You are strongly encouraged to contact Dr. Karen Peterson (contact
information provided below) before beginning the process of putting a
Phase II Competing Renewal application together. Prospective applicants
are also strongly encouraged to submit to Dr. Peterson a letter of
intent that includes the following information:

-   Descriptive title of the proposed research

-   Name, address, and telephone number of the Principal Investigator

-   Names of other key personnel

-   Participating institutions

-   Funding Opportunity Announcement Number (e.g., PA-06-XXX)

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 NIH staff to estimate the potential review
workload and plan the review. It is expected that only a portion of
NIAAA SBIR/STTR Phase II awards will be eligible for a competing renewal
grant.

The following examples would make appropriate topics for proposed SBIR
or STTR Phase II competing renewal projects.

These examples are meant for illustrative purposes and are not exclusive
of other appropriate activities:

-   Preclinical studies, including pharmacology and toxicology, beyond
    those conducted under the Phase I (R43) and initial Phase II (R44)
    grants. Some in vivo or in vitro studies would be expected to have
    been carried out in Phase I or the initial Phase II grant.

-   Completion of studies as required by the Food and Drug
    Administration (FDA) for Investigational New Drug (IND) or
    Radioactive Drug Research Committee (RDRC) application.

-   Development and clinical evaluation of new alcohol-sensitive
    biomarkers.

-   Assessment of devices with regard to performance standards related
    to the FDA approval process.

-   Safety and effectiveness studies of novel medical devices.

-   Biocompatibility studies of surface materials of putative medical
    implants.

-   Evaluation of novel imaging approaches for diagnostic purposes.

-   Clinical studies in support of New Drug Application approval by the
    FDA.

-   Clinical studies in support of Pre-Market Approval for
    biomarkers/medical devices by the FDA.

Direct your questions about scientific/research issues to:

Joanne B. Fertig, Ph.D.

Telephone: (301) 443-0635

Fax: (301) 443-8774

Email: <jf75t@nih.gov>

Peter B. Silverman, Ph.D.

Telephone: (301) 402-6966

Email: <psilverm@mail.nih.gov>

Forward Letter of Intent to:

Karen P. Peterson, Ph.D.

Acting Chief, Research Policy and Special Projects Branch

Office of Scientific Affairs

National Institute on Alcohol Abuse and Alcoholism

5635 Fishers Lane

Bethesda, MD 20892

Phone; (301) 451-3883, Fax: (301) 443-6077

Email: <kpeterso@mail.nih.gov>

[]{#__RefHeading___Toc124236881 .anchor}Pharmaceutical Development for
Alcoholism Treatment

Applied and, where appropriate, clinical research on pharmacologic
agents for use in the treatment or medical management of alcoholism,
disorders resulting from alcoholism, the improvement and refinement of
drugs currently available for therapeutic purposes, or drugs suitable
for use in basic research studies on alcohol addiction. Areas that may
be of interest to small businesses include, but are not limited to:

A. Development of agents to attenuate drinking behavior, e.g., drugs to
curb craving.

B. Development of aversive agents such as disulfiram that attenuates
drinking behavior.

C. Development of agents to treat acute alcohol withdrawal.

D. Development of agents to treat the protracted withdrawal syndrome.

E. Development of neurotransmitter agonists and antagonists, or drugs
that enhance the efficacy of neurotransmission, which are capable of
improving or reversing alcohol-induced cognitive impairments.

F. Development of agents to induce sobriety in intoxicated individuals
(amethystic agents).

G. Development of agents to diminish drinking by treating associated
psychiatric disorders and/or drug abuse.

H. Development of improved methods of drug delivery for the treatment of
alcoholism. The systems developed must be capable of maintaining
therapeutic drug levels for extended periods of time to alleviate
compliance problems.

I. Development of drugs for the treatment of alcoholic hepatitis,
cirrhosis, pancreatitis, and cardiomyopathy.

J. Research on the pharmacokinetics of concurrent ethanol and other drug
use.

For clinical questions, contact:

Joanne B. Fertig, Ph.D.

\(301\) 443-0635

Email: <jf75t@nih.gov>

For pre-clinical questions, contact:

Mark Egli, Ph.D.

\(301\) 594-6382

Email: <me114r@nih.gov>

[]{#__RefHeading___Toc124236882 .anchor}Diagnostic Assessment of Alcohol
Use Disorders and Comorbidity

Innovative self-report and biochemical approaches to the early
identification of alcohol use problems and diagnosis of alcohol use
disorders and comorbidity are needed. The research design should include
measurements of reliability and validity in appropriate population
samples. Areas that may be of interest to small businesses include, but
are not limited to:

A. Development or adaptation of diagnostic instruments measuring alcohol
use disorders and related comorbid conditions in general population and
treated samples, including youth, the elderly, pregnant women, ethnic
minorities, the handicapped, and persons with low-level reading skills).

B. Development and testing of methodology to translate diagnostic
instruments for alcohol use disorders and associated disabilities into
relevant different languages (e.g., various Hispanic languages).

C. Development and testing of computer algorithms necessary to derive
diagnoses of alcohol use disorders and associated comorbidity.

D. Development of computer software for utilization of assessment
instruments in a clinical setting. Development and testing of detailed
audio, visual, or printed training modules to accompany diagnostic
instruments.

E. Application of statistical and mathematical analyses to develop
models designed to increase our understanding of (1) etiologic
relationship between alcohol use disorders and their associated
disabilities, and (2) the factors that influence the initiation and
maintenance of alcohol use disorders.

F. Identification, validation, and assay of physiological and/or
biochemical measures capable of identifying individuals at risk for
becoming alcoholics or individuals who already exhibit alcohol problems.
The accurate measurement of acetaldehyde conjugates or abnormal
glycoconjugates in blood is one promising approach.

G. Development of biochemical/physiological methods for early detection
of alcohol-derived pathology, e.g., alcoholic hepatitis or cirrhosis.
Development and characterization of markers to accurately predict
vulnerability to alcohol-derived pathology.

Cherry Lowman, Ph.D.

\(301\) 443-0637

Email: <clowman@mail.nih.gov>

[]{#__RefHeading___Toc124236883 .anchor}Treatment of Alcoholism

A. Development and evaluation of innovative treatment approaches. These
approaches can include outreach, shelter, detoxification, treatment and
recovery, and alcohol-free housing, as appropriate.

B. Development and validation of tools to aid in the clinical management
of patients, including selection of appropriate interventions, process
evaluation, assessment of outcome, aftercare, and patient tracking, in
various treatment settings.

Cherry Lowman, Ph.D.

\(301\) 443-0637

Email: <clowman@mail.nih.gov>

[]{#__RefHeading___Toc124236884 .anchor}Measurement of Alcohol
Consumption/Impairment

Development of new methods for quantitative measurement of alcohol
consumption, development of new and more accurate cost-effective
technological approaches for non-invasive measurement of blood alcohol
concentration, and development of novel approaches to measure and
quantify alcohol-induced impairment of human performance. Areas that may
be of interest to small businesses include, but are not limited to:

A. Development of new methods for quantitatively estimating alcohol use
over a period of days or weeks. The approaches should have high
sensitivity and specificity and have utility in a variety of settings,
including treatment compliance monitoring. Integration of measurement
devices with electronic devices to transmit and/or record data in real
time is desirable.

B. Development of new and more accurate cost-effective technological
approaches (such as breathalyzers) for non-invasive measurement of blood
alcohol concentration in law enforcement, workplace, research, and
clinical settings.

C. Development of instruments involving tests of behavioral, cognitive,
and/or motor function to measure and quantify alcohol-induced impairment
of human performance. Such instruments may be computer-based and may be
designed to simulate specific work situations such as driving
performance, use of complex machinery, learning and retention of new
information.

Cherry Lowman, Ph.D.

\(301\) 443-0637

Email: <clowman@mail.nih.gov>

[]{#__RefHeading___Toc124236885 .anchor}Promoting Adherence to Medical,
Pharmacologic, and Behavioral Treatments

Several recent reports and literature reviews point to the continuing
need for improving adherence to therapeutic regimens. Adherence rates
vary considerably across diseases and treatments, measuring instruments,
and populations, with rates ranging from 30% to 60% in many instances.
The reasons for non-adherence are multifaceted. Health-care providers,
organizational systems, and patient factors all play a role in adherence
to therapeutic regimens. Thus, to understand and eventually improve
adherence, conceptual frameworks and interventions need to take into
account institutional, system, situational, interpersonal, and personal
factors as well as the characteristics of the illness or condition and
of the treatment regimen. While extensive research exists and successful
techniques have been identified, greater efforts are needed to develop
and implement programs based upon these findings. Applications are
sought to develop:

A. Programs to implement effective interventions and to evaluate their
implementation.

B. Professional education courses or web-based training modules on
interventions and to monitor their effectiveness.

In both cases, the emphasis is on how to encourage health practitioners
to utilize interventions that will improve their patients' adherence to
medical, pharmacologic, and behavioral regimens for alcohol abuse and
dependence.

Margaret E. Mattson, Ph.D.

\(301\) 443-0638

Email: <mmattson@mail.nih.gov>

[]{#__RefHeading___Toc124236886 .anchor}Prevention

Development and evaluation of innovative prevention/intervention
programs, or specific materials for integration into existing programs,
which utilize state-of-the-art technology and are based on currently
accepted clinical and behavioral strategies. Applicants are strongly
encouraged to consult with research methodologists and statisticians to
ensure that state-of-the-art approaches to design, analysis, and
interpretation of studies under this topic are used. Areas that may be
of interest to small businesses include, but are not limited to:

A. Development and evaluation of innovative prevention/intervention
programs, or specific materials for integration into existing programs,
which utilize state-of-the-art technology and are based on currently
accepted clinical and behavioral strategies. Special emphasis should be
placed on the needs of high-risk groups, ethnic and minority
populations, youth, children of alcoholics, women, the handicapped, and
the elderly. Examples of such materials include school-based curricula,
interactive videos, computer-based multimedia programs, training manuals
for teachers or parents, and community-based programs.

B. Development and evaluation of educational materials designed to
inform the elderly about specific age-related risks for alcohol
problems. Particular attention should be given to age-related reductions
in alcohol tolerance, interactions between alcohol and prescription and
over-the-counter medications, possible exacerbation of some medical
conditions common among the elderly, potential biomedical and behavioral
consequences of excessive alcohol use, and the role of alcohol in falls,
fires, burns, pedestrian and traffic injuries, and other unintentional
injuries.

C. Development and evaluation of educational materials designed to
provide information on date rape, spouse abuse, child abuse, and other
types of violence that have been found to be associated with alcohol use
and/or abuse. The development of strategies for preventing victimization
would also be appropriate.

D. Development of instruments and educational materials designed to
improve the effectiveness of employee assistance programs, especially
with respect to assessment, referral, and health promotion as it relates
to alcohol use and abuse.

E. Development and evaluation of statistical analysis programs tailored
to the design and analysis of alcohol prevention-relevant research.
Programs could focus on a variety of areas including: imputation of
missing data under varying design assumptions; simulation of
distributions of outcomes based on varying mixtures of sample
populations; application of chronic or infectious disease models to
targeted communities; and models of the potential effect of various
policy-based interventions, such as increased taxation or reduction of
outlet density by license revocation and control.

Robert C. Freeman, Ph.D.

\(301\) 443-8820

Email: <rfreeman@mail.nih.gov>

[]{#__RefHeading___Toc124236887 .anchor}Health Services Research on
Alcohol-Related Problems

Research projects are sought that will expand knowledge and improve
delivery of alcohol treatment and prevention services. The research
objectives include, but are not limited to: the effects of
organizational structures and financing mechanisms on the availability,
accessibility, utilization, delivery, content, quality, outcomes, and
costs of alcohol treatment services. Objectives also include studying
the effectiveness and cost-effectiveness of alcohol prevention services
in reducing the demand for health care services and improving the
methodological tools useful for conducting health services research.
Areas that may be of interest to small businesses include, but are not
limited to:

A. Development of computer software or other protocols to assist in the
management of treatment delivery. Software should be useful for
assessment, diagnosis, patient placement criteria, monitoring of
services received, tracking patient progress, and billing.

B. Development of software or other protocols to assist clinicians in
scoring and norming results of commonly used assessment instruments.
Output should be in a form useful for guiding client feedback.

C. Development of software or other protocols to assist treatment
programs and service agencies in measuring, assessing, or otherwise
documenting indicators of clinical performance or improvements in
quality of service provision.

D. Development of products to facilitate the adoption of evidence-based
research findings into everyday clinical practice. For example, training
videos or other materials illustrating research-based improvements in
treatment practice could provide clinicians with practical examples of
orienting patients to pharmacotherapy, assessing motivational readiness,
giving motivational feedback, establishing contracts for behavioral
couple therapy, and conducting brief interventions in primary care
settings.

E. Development of software or other protocols to facilitate the
incorporation of screening and identification tools into routine usage
in primary care, emergency, obstetric, mental health, and other health
care settings. Research projects should facilitate both the provisions
of brief interventions and effective referral to specialized alcohol
treatment.

F. Development of software or other protocols for monitoring clinical
costs of alcohol treatment services. These tools should provide a
user-friendly system of monitoring costs that could be implemented
without additional accounting expertise by the staff at a typical
treatment setting. At the same time, such tools should be defensible as
measures of the true opportunity costs of providing alcohol treatment
services. Such software might be bundled with billing software.

Robert Huebner, Ph.D.

\(301\) 443-4344

Email: <bhuebner@mail.nih.gov>

[]{#__RefHeading___Toc124236888 .anchor}Training in Alcoholism
Assessment and Treatment Techniques

Development of educational materials, including computer-based
approaches, for training of health professionals in the use of various
assessment techniques and treatment strategies. Areas that may be of
interest to small businesses include, but are not limited to:

A. Development of educational materials, including computer-based
approaches, for training of health professionals and paraprofessionals
in the use of various assessment techniques and instruments.

B. Development and evaluation of clinical protocols which enable health
professionals to relate assessment to appropriate intervention and
treatment strategies.

C. Development and evaluation of effective health professions training
programs which utilize state-of-the-art educational technology and are
based upon currently accepted clinical and behavioral strategies.
Examples include experiential teaching technologies such as standardized
patient, interactive video, and computer simulation.

Jason Lazarow, M.Ed.

\(301\) 435-8043

Email: <jlazarow@mail.nih.gov>

[]{#__RefHeading___Toc124236889 .anchor}Fetal Alcohol Syndrome (FAS) and
Alcohol-Related Birth Defects

FAS is a severe developmental disorder that includes mental retardation,
cognitive and behavioral disabilities, and motor impairment. The NIAAA
supports research leading to improved diagnosis and assessment of
impairment and disability, as well as the development of tools to
enhance academic and daily living skills. Areas that may be of interest
to small businesses include, but are not limited to:

A. Development of diagnostic and/or screening methods that can be used
prenatally to identify fetuses affected by ethanol.

B. Development and validation of assessment methods to provide more
accurate clinical diagnosis of FAS at all life stages.

C. Development and testing of skill-building, therapeutic, and education
program products that enhance the social, cognitive, adaptive and motor
abilities of individuals with FAS or fetal alcohol effects.

D. Development of accurate measures of the responsiveness of children
affected by prenatal exposure to alcohol to stress and predictors of
vulnerability to alcohol-drinking or other psychopathology during
adolescence and adulthood.

E. Development and evaluation of educational and training programs
designed to enhance the skills of non-professional caregivers in dealing
with the problems associated with FAS.

For clinical research questions, contact:

Deidra Roach, M.D.

\(301\) 443-5820

Email: <droach@mail.nih.gov>

For prevention research questions, contact:

Marcia Scott, Ph.D.

\(301\) 402-6328

Email: <mscott@mail.nih.gov>

For basic research questions, contact:

Laurie Foudin, Ph.D.

\(301\) 443-0912

Email: <lf29z@nih.gov>

[]{#__RefHeading___Toc124236890 .anchor}Science Education

The NIAAA Science Education program is intended to: (1) supplement
in-service education of health professionals and paraprofessionals with
respect to their recognition and treatment of alcohol-related medical
problems; (2) stimulate the interest of both precollege and college
students, especially among underserved populations, in career
opportunities in the biomedical and behavioral sciences generally and
the alcohol field specifically; (3) enhance precollege education in the
classroom, both directly and via support to teachers, in the life
sciences and in education regarding science-related personal and
societal challenges; and (4) improve public understanding of science
generally and with particular regard to the role of and need for alcohol
research. The NIAAA Science Education program complements, but does not
duplicate, the education and training components described under other
NIAAA topics.

Efforts in science education might include, but are not limited to:

A. Development of methodology to transfer new alcohol research knowledge
and directions of scientific knowledge growth to curriculum developers
and science teachers, consistent with the National Research Council\'s
National Science Education Standards (1996).

B. Development and testing of specific science education materials,
activities or programs to implement one (or more) of the four stated
objectives of the NIAAA science education program. The creative use of
emerging educational and telecommunications technologies in this regard
is of special interest.

C. Development and testing of methodology to present science and alcohol
abuse-related curricula and educational materials to particular
underserved group(s) in culturally relevant ways, and/or to obtain
community support for education in science-related and alcohol-related
topics that may be culturally sensitive.

D. Development of resource materials on scientific career opportunities
in fields of interest to NIAAA, reflecting activities (e.g., focus
groups) and research on motivational factors influencing high school
students\' career choices, and reflecting economic and social
projections of career outlooks for the 21st century.

Jason Lazarow, M.Ed.

\(301\) 435-8043

Email: <jlazarow@mail.nih.gov>

[]{#__RefHeading___Toc124236891 .anchor}Longitudinal Analysis of Complex
Survey Data

Despite recent advances made in developing software programs for
longitudinal latent and observed variable structural modeling, very
little has been accomplished in this research arena regarding modeling
with complex sample data. Currently there is no comprehensive
statistical software package that allows such modeling that takes into
account sampling weights, stratification and clustering while at the
same time allowing for these observed variables to be either
categorical, continuous, or a combination of both. Moreover, there is no
currently available comprehensive statistical package that allows for
the longitudinal analysis of complex survey data for the variety of
models necessary for the analysis of alcohol-related longitudinal data
(e.g., linear, probit and logistic regression, survival analysis
\[continuous and discrete-time allowing for time-varying covariates\],
path analysis, exploratory and confirmatory factor analysis, growth
modeling, growth mixture modeling, multilevel modeling, linear and
nonlinear growth modeling, and combinations and variants of these
models).

Bridget Grant, Ph.D.

\(301\) 443-7370

Email: <bgrant@willco.niaaa.nih.gov>

[]{#__RefHeading___Toc124236892 .anchor}Research Tools

The NIAAA supports basic and applied research to develop new or improved
tools to enhance laboratory studies on humans and animals. Examples
include transgenic animal models, cell lines, new ligands for
neuroimaging, and simulators of alcohol impairment. Areas that may be of
interest to small businesses include, but are not limited to:

A. Development of animal models, including transgenic animals,
possessing specific traits of significance for the study of alcoholism,
or for the study of specific pathologic disease states which arise from
excessive alcohol consumption.

B. Development of a hepatocyte cell line capable of maintaining
viability and metabolic functions in culture systems for an indefinite
period.

C. Development of new methods of ethanol administration to animals that
produce precise dose control.

D. Development of specialized cell culture chambers to provide
controlled administration of ethanol to in vitro cell systems.

E. Development of ligands for alcohol-relevant neurotransmitter systems
which will enhance the potential usefulness of PET and SPECT imaging
technologies for the study of the etiology of alcoholism and related
brain pathology.

F. Development of instruments that simulate driving, piloting aircraft,
or using other complex machinery under hypothetical or actual drinking
handicaps and are designed to predict fatal and nonfatal accident
involvement.

Laurie Foudin, Ph.D.

\(301\) 443-0912

Email: <lf29z@nih.gov>

[]{#__RefHeading___Toc124236893 .anchor}Development and Clinical Testing
of Biochemical Markers

The development of effective biochemical markers represents a powerful
means for early diagnosis and treatment of alcohol dependent/abuse
patients and for the identification of individuals who have a
predisposition for alcoholism. There are two different types of
biochemical markers: trait markers and state markers.

Trait biomarkers have the ability to detect inborn characteristics of
individuals who are vulnerable for alcoholism. This type of marker would
be invaluable for screening of high-risk individuals (e.g., children of
alcoholics) and targeting them with preventive or early treatment
interventions. In addition, trait markers might assist practitioners in
identifying subpopulations of alcoholics who may need different
treatment strategies. An ideal trait marker should have several
features. First, it should display validity in detecting people
susceptible to alcoholism, particularly before the onset of alcoholism
or during periods of stable abstinence. Second, it should be easily and
reliably measured. Third, it should be specific for alcoholism only and
not affected by other medical or psychiatric disorders or drugs. Since
alcoholism is a complex disease, it is likely that more than one type of
gene and protein exist as trait marker.

State markers or markers of alcohol consumption serve several important
purposes. First, they can assist physicians in diagnosing individuals
with chronic drinking problems, particularly patients who deny excessive
drinking. Moreover, they may also identify individuals in early stages
of heavy drinking, thus avoiding the long-term medical, psychological,
and social consequences of chronic alcoholism. Second, state biomarkers
can aid in the diagnosis and treatment of other diseases (liver
diseases, pancreatitis, and cardiovascular diseases) that were, at
least, caused by excessive drinking. Third, they are useful in alcohol
treatment and prevention programs. Since the goal of many of programs is
abstinence, monitoring relapse is important in gauging success. Last,
state biomarkers are important in clinical alcohol trials. Although
self-reports have become more sophisticated and valid (e.g., Timeline
Followback), they still rely on accurate reporting. These new and
reliable biomarkers could then be used to confirm the self-report.
Several biomarkers with certain limitations are currently in use
including carbohydrate-deficient transferrin (CDT), gamma glutamy
transferase (GGT), aspartate aminotransferase (AST), alanine
aminotransferase (ALT), and mean corpuscular volume (MCV). New state
markers need to be developed that incorporate the following attributes:
validity, reliability, stability, cost, practicability, acceptability,
and transportability.

Areas that may be of interest to small businesses include, but are not
limited to:

A. Develop and evaluate clinically alcohol-sensitive biomarkers to
identify individuals who are predisposed to alcoholism; determine
relapse; measure levels of drinking; and determine alcohol-induced
tissue damage.

B. Identify genes, and proteins that are expressed during the
development of alcohol dependence for biomarker development.

C. Develop methodologies for high throughput identification of alcohol
metabolites and other signaling molecules that are expressed during
alcohol intake.

D. Use knowledge of genetic and molecular mechanisms underlying
alcohol-induced organ damage (including alcohol-related liver, pancreas,
heart disease and FAS) to develop new biomarkers of tissue and cell
damage.

E. Evaluate clinically innovative alcohol-sensitive biomarkers (trait,
relapse, organ damage) for sensitivity and specificity.

For clinical questions contact:

Raye Z. Litten, Ph.D.

\(301\) 443-0636

Email: <rlitten@niaaa.nih.gov>

For pre-clinical questions, contact:

Denise A. Russo, Ph.D.

\(301\) 402-9403

Email: [drusso@mail.nih.gov](mailto:drusso@niaaa.nih.gov)

[]{#__RefHeading___Toc124236894 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Karen P. Peterson, Ph.D.

Acting Chief, Research Policy and Special Projects Branch

Office of Scientific Affairs

National Institute on Alcohol Abuse and Alcoholism

5635 Fishers Lane

Bethesda, MD 20892

For Federal Express delivery, use:

Rockville, MD 20852-1705

Phone: (301) 451-3883, Fax: (301) 443-6077

Email: <kpeterso@mail.nih.gov>

For administrative and business management questions, contact:

Ms. Judy Fox

Grants Management Officer

National Institute on Alcohol Abuse and Alcoholism

Phone: (301) 443-4704, Fax: (301) 443-3891

Email: <js182a@nih.gov>

[]{#__RefHeading___Toc124236895 .anchor}National Institute of Allergy
and Infectious Diseases (NIAID)

The NIAID\'s Division of AIDS, Division of Allergy, Immunology, and
Transplantation, and Division of Microbiology and Infectious Diseases
fund SBIR/STTR grants on topics related to their mission and activities
as described below. Questions on specific research areas may be
addressed to the NIAID Program Officials listed below. General questions
on the NIAID SBIR and STTR programs and on administrative and business
management may be addressed to contacts listed for the NIAID section.
When possible, *[applicants are encouraged to use email]{.underline}*
for communication.

For information about NIAID\'s Small Business High-Priority Areas of
Interest, please visit
<http://www.niaid.nih.gov/ncn/sbir/sbirareas.htm>.

[]{#__RefHeading___Toc124236896 .anchor}Phase II Competing Renewal
Awards

The NIAID will accept Phase II SBIR/STTR Competing Renewal SBIR/STTR
grant applications to continue the process of developing products that
require approval of a Federal regulatory agency (e.g., FDA). Projects
that are particularly encouraged include those in the NIAID Small
Business High Priority Areas of Interest
(<http://www.niaid.nih.gov/ncn/sbir/sbirareas.htm>) and also:

-   therapeutics (drugs or antibodies) to treat HIV infections

-   therapeutics (drugs or antibodies) for HIV-related opportunistic
    infections

-   anti-inflammatory therapeutics

-   transgenic transplantation strategies

-   new or improved vaccines, antiviral or antimicrobial agents for
    infectious diseases

NIAID will accept Phase II Competing Renewal applications for a project
period of up to three years and a budget not to exceed a total cost of
\$1 million per year (including direct cost, F&A, and fee/profit)
provided the time period and amount are well justified.

The total amount of all consultant costs and contractual costs normally
may not exceed 50% of the total costs requested for initial SBIR Phase
II applications. SBIR Phase II Competing Renewal grant applications may
exceed this guideline, however, when well justified and when those costs
are necessary to support clinical studies or trials and related
expenses. Examples of well founded reasons for exceeding this guideline
include, but are not limited to, subcontracts for safety, toxicity, or
efficacy testing in animals, subcontracts to clinical research
organizations to carry out aspects of clinical evaluation or
subcontracts to assure compliance with Good Manufacturing Practices
expectations of the FDA.

Human clinical trials may not be a component of the proposed research.
As announced in Notice NOT-AI-05-021
(<http://grants.nih.gov/grants/guide/notice-files/NOT-AI-05-021.html>)
NIAID will only support investigator-initiated clinical trials through a
two part grant process: (1) a clinical trial planning grant followed by
(2) a clinical trial implementation cooperative agreement.

NIAID does NOT request a letter of intent. However, prior to submission
of a Competing Renewal application, applicants are strongly encouraged
to contact:

Gregory Milman, Ph.D.

Division of Extramural Activities

National Institute of Allergy and Infectious Diseases

Room 2153, MSC-7610

6700-B Rockledge Drive

Bethesda, MD 20892-7610 (US Mail)

Rockville, MD 20817-7610 (Delivery Services)

Telephone (301) 496-8666

Fax: (301) 402-0369

Email: <gm16s@nih.gov>

[]{#__RefHeading___Toc124236897 .anchor}Division of AIDS

The Division of AIDS (DAIDS) supports research on the pathogenesis,
natural history, and transmission of HIV and HIV disease, and promotes
progress in its detection, treatment, and prevention.

Director: Dr. Ed Tramont

\(301\) 496-0545

Email: <et89f@nih.gov>

Biostatistics Research Branch

Statistical methods in HIV studies.

Dr: Misrak Gezmu

\(301\) 435-3722

Email: [mgezmu@niaid.nih.gov](mailto:mgezmy@niaid.nih.gov)

Basic Sciences Program

Supports basic and applied research on the causes, diagnosis, treatment
and prevention of HIV and AIDS.

Director: Dr. Carl Dieffenbach

\(301\) 496-9112

Email: <cdd@nih.gov>

A. ***[Epidemiology Branch.]{.underline}*** Population-based research of
HIV transmission and associated biological, behavioral, and
environmental factors including correlation between immunologic and
virologic events and clinical outcome trends in natural history;
correlation between immunologic and virologic events and clinical
outcome; and trends in natural history.

Contact: Joana Roe

\(301\) 435-3759

Email: <jr108r@nih.gov>

B. ***[Pathogenesis Branch.]{.underline}*** Molecular and cellular
biology, virology, and immunology of virus-host interactions and
mechanisms of immunopathogenesis and HIV transmission.

Contact: Ann Namkung, M.P.H.

\(301\) 496-9176

Email: <an107z@nih.gov>

C. ***[Targeted Interventions Branch.]{.underline}*** Research areas:
(1) targeted therapeutics emphasizing under-explored viral and cellular
targets; (2) innovative therapeutic strategies including immune-based
and gene-based therapies and therapeutic vaccines; (3) translational
research for effective therapeutics spanning preclinical discovery to
pilot clinical studies in humans; (4) preclinical discovery and
development of topical microbicides and other entities for non-vaccine
prevention strategies; and (5) animal models for evaluating new
therapeutic entities, regimens, and strategies.

Contact: Dr. Roger Miller

\(301\) 496-6430

Email: <rm42i@nih.gov>

Vaccine and Prevention Research Program

Supports the development of vaccines and other biomedical and behavioral
interventions to prevent AIDS.

Director: Dr. Margaret (Peggy) Johnston

\(301\) 402-0846

Email: <pj7p@nih.gov>

A. ***[Vaccine Clinical Development Branch.]{.underline}*** Research
areas: (1) coordination of phase I, II, and III domestic and
international clinical trials of candidate AIDS vaccines; (2)
coordination of the characterization of immune responses in HIV-infected
and uninfected immunized volunteers; and (3) coordination of studies to
identify, validate, and standardize immunologic and virologic markers
for monitoring response of participants in vaccine clinical trials.

Acting Chief: Dr. Joseph Chiu

\(301\) 402-2311

Email: <jchiu@niaid.nih.gov>

B. ***[Prevention Science Branch.]{.underline}*** Conduct of domestic
and international phase I, II, and III clinical trials to evaluate
HIV/AIDS prevention strategies, including microbicides,
chemoprophylactic agents, and other biomedical and behavioral risk
reduction interventions. Basic research on mechanisms of sexual and
mother-to-child HIV transmission supportive of new biomedical strategies
for interrupting transmission. Translational research on microbicides,
spanning preclinical through pilot human clinical research. Pilot
clinical studies of the performance of microbicide vehicles and
applicators with regard to coverage of and persistence on mucosal
surfaces as well as behavioral acceptability.

Acting Chief: Dr. Monica Ruiz

\(301\) 435-8896

Email: <mruiz@niaid.nih.gov>

C. ***[Preclinical Research and Development Branch.]{.underline}***
Support of applied preclinical development of candidate AIDS vaccines,
delivery methods, and adjuvants for the prevention of AIDS; promotion
and evaluation of safety and efficacy of the prevention modalities,
especially novel vaccine concepts identified in preclinical models
including trials in non-human primates; genetic and immunologic
variation; and mucosal immunity in SIV, HIV, and SHIV models.

Contact: Dr. Yen Li

\(301\) 496-3816

Email: <yl81g@nih.gov>

Therapeutics Research Program

Develops and oversees research and development of therapies for HIV
disease, including complications and co infections, and cancers, in
adults, infants, children, and adolescents.

Director: Dr. Sandra Lehrman

\(301\) 496-8210

Email: <slehrman@niaid.nih.gov>

A. ***[Clinical Research Management Branch.]{.underline}*** Management
of grants and contracts supporting therapeutic clinical trials.

Chief: Ms. Margaret Matula

\(301\) 496-8214

Email: <mmatula@niaid.nih.gov>

B. ***[Drug Development and Clinical Sciences Branch.]{.underline}***
Discovery and preclinical development of experimental therapies for HIV,
TB and other infectious diseases; maintenance of a database of potential
anti-HIV and -OI compounds; immunologic, virologic, and pharmacologic
research related to the design and conduct of clinical trials.

Contact: Dr. Chuck Litterst

\(301\) 402-0132

Email: <cl30x@nih.gov>

C. ***[HIV Research Branch.]{.underline}*** Clinical research of
strategies to treat adult primary HIV infection and complications;
strategies to augment HIV immune responses and general host immunity.

Chief: Dr. Carla Pettinelli

\(301\) 402-5582

Email: <cp22n@nih.gov>

D. ***[Complications & Co-Infections Research Branch.]{.underline}***
Preclinical and clinical research to develop improved therapies for the
treatment and prophylaxis of AIDS-associated opportunistic infections
and other complications, including Pneumocystis carinii pneumonia,
tuberculosis, Mycobacterium avium disease, hepatitis C, cryptococcosis
and Cryptosporidium parvum (the microsporida). Research on metabolic
complications of anti-retroviral therapy, emergence of resistance to
existing therapies and drug-drug interactions.

Chief: Dr. Barbara Laughon

\(301\) 402-2304

Email: <bl17u@nih.gov>

E. ***[Pediatric Medicine Branch.]{.underline}*** HIV therapies in
children and adolescents, strategies to reduce transmission from mother
to infant or fetus.

Contact: Daniella Liynat

\(301\) 435-3775

Email: <DL28a@nih.gov>

[]{#__RefHeading___Toc124236898 .anchor}Division of Allergy, Immunology,
and Transplantation

The Division of Allergy, Immunology, and Transplantation (DAIT) supports
studies of the immune system in health and the cause, pathogenesis,
diagnosis, prevention, and treatment of disease caused by immune
dysfunction.

Director: Daniel Rotrosen, M.D.

\(301\) 496-1886

Email: <drotrosen@niaid.nih.gov>

A. ***[Asthma, Allergy, and Inflammation Branch.]{.underline}*** Asthma,
atopic dermatitis, hypersensitivity reactions, rhinitis, sepsis,
sinusitis, urticaria, molecular basis of hypersensitivity, basic studies
of asthma and allergy mechanisms, new therapies for asthma and allergic
diseases, epidemiology and prevention, phagocyte biology, and mechanisms
of host defense. Methodologies to design, manage, and analyze clinical
and epidemiologic research of the etiology, prevention, and treatment of
asthma, allergy, and inflammatory diseases.

Chief: Dr. Charles Hackett

\(301\) 496-8973, Fax: (301) 402-2571

Email: <chackett@niaid.nih.gov>

B. ***[Basic Immunology Branch.]{.underline}*** Origin, maturation, and
interactions of immune cells, immune cell receptors, ligands, cytokine
biology, molecular basis of activation, antigen recognition, tolerance,
immune response regulation, hematopoiesis and stem cell biology,
enhancement of vaccine effectiveness in neonates and adults and basic
immunology of vaccines and immunotherapeutics as medical countermeasures
for biodefense..

Chief: Dr. Helen Quill

\(301\) 496-7551, Fax: (301) 402-2571

Email: <hquill@niaid.nih.gov>

C. ***[Clinical Immunology Branch.]{.underline}*** Preclinical and
clinical research to develop and improve therapies for the treatment of
autoimmune diseases, primary immune deficiencies (not HIV), basic
research of disease mechanisms, immunotherapy of disease processes,
disorders mediated by lymphocyte products, and mucosal immunity.

Chief: Dr. James McNamara

\(301\) 451-3121, Fax: (301) 480-1450

Email: <jmcnamara@niaid.nih.gov>

D. ***[Transplantation Immunobiology Branch.]{.underline}*** Acute and
chronic graft rejection, allogeneic and xenogeneic transplantation,
development of immunomodulatory agents to prevent and treat graft
rejection, genomics of the alloimmune response, hematopoietic stem cell
transplantation, major histocompatibility complex, minor
histocompatibility antigens, infectious and malignant complications of
immunosuppression in transplantation, technologies for MHC typing.

Chief: Dr. Shiv Prasad

\(301\) 496-5598, Fax: (301) 480-0693

Email: <sprasad@nih.gov>

[]{#__RefHeading___Toc124236899 .anchor}Division of Microbiology and
Infectious Diseases

The Division of Microbiology and Infectious Diseases (DMID) supports
research to control diseases caused by all infectious agents, except
HIV, through basic investigation of microbial physiology and antigenic
structure, pathogenesis, clinical trials of drugs and vaccines, and
epidemiologic studies. DMID also supports medical diagnostics research,
which is defined as research to improve the quality of patient
assessment and care that would result in the implementation of
appropriate therapeutic or preventive measures. DMID does not support
research directed at decontamination or the development of
environmentally oriented detectors, whose primary purpose is the
identification of specific agents in the environment. Note that some of
the organisms and toxins listed below are considered NIAID priority
pathogens or toxins for biodefense research.

Director: Dr. Carole Heilman

\(301\) 496-1884

Email: <ch25v@nih.gov>

A. ***[Bacteriology and Mycology Branch.]{.underline}*** Bacterial
diseases: anthrax and other zoonotic infections (plague, tularemia,
brucellosis, leptospirosis, glanders, melliodosis), actinomycete
infections, enterococcal infections, legionellosis, Lyme disease,
nosocomial infections, rickettsial and related diseases: ehrlichiosis,
anaplasmosis, bartonellosis, typhus, Q fever, tickborne spotted fevers,
sepsis, staphylococcal infections, urinary tract infections,
vector-borne bacterial infections; fungi and fungal diseases:
aspergillosis, blastomycosis, candidiasis, coccidioidomycosis,
cryptococcosis, histoplasmosis, Pneumocystis carinii, other primary and
opportunistic fungal infections; antibacterial and antifungal drug
resistance; host-pathogen interactions; genetics, molecular, and cell
biology; medical bacteriology and mycology; microbial structure and
function; development of vaccines, drugs, and medical diagnostics;
clinical trials of antibacterial and antifungal agents; and application
of proteomics and genomics to facilitate advances in the areas listed
above. The Bacteriology and Mycology Branch does not support
applications covering environmental detection and decontamination.

Chief: Dr. Dennis M. Dixon

\(301\) 496-7728, Fax: (301) 402-2508

Email: <dd24a@nih.gov>

B. ***[Enteric and Hepatic Diseases Branch.]{.underline}*** Research
areas: (1) diseases and organisms: astrovirus, Bacteroides,
Campylobacter, Clostridium including botulinum neurotoxin, commensals,
Crohn\'s Disease, diarrhea, enterotoxins, Escherichia coli,
gastroduodenal disease, gastroenteritis, Guillain-Barré, Helicobacter,
Listeria, normal flora, Noroviruses including Norwalk, ricin toxin,
rotaviruses, Salmonella, Shigella, Staphylococcus, toxins, ulcers,
Vibrio, enteric Yersinia, viral hepatitis, hepatitis A, B, C, D, E, G,
TTV, SEN-V, animal model hepatitis viruses and newly identified
hepatitis viruses; (2) basic virology and bacteriology, genome
sequencing, natural history and pathogenesis; (3) immunology of
infectious diseases including mechanisms of recovery and persistence,
protective immune responses and immunopathogenesis in humans and animal
models; (4) vaccine research and development including novel approaches
and delivery systems to prevent infection as well as to control and
treat disease; (5) development and evaluation of adjuvants and vaccine
vectors; (6) identification of new therapeutic targets and development
and evaluation of therapeutics; (7) immunotherapy discovery and
development; (8) epidemiology, ecology, zoonoses, and transmission; (9)
antimicrobial resistance of these organisms in non-nosocomial settings;
(10) development of tools for rapid medical diagnosis of organisms,
specific targets, disease, and markers of disease outcome; (11) clinical
studies and trials; (12) development of model systems to study infection
and disease and evaluate vaccines and drugs; and (13) characterization
and exploitation of the role of normal flora in disease preventive
therapy. Special emphasis areas include development of a single
diagnostic to identify multiple diarrheal pathogens, pediatric vaccines
to prevent the major causes of worldwide diarrhea, more stable vaccines
and formulation improvements, hepatitis C vaccines, novel therapeutics
for chronic hepatitis B and C, and improved therapies and vaccines for
the botulinum neurotoxins.

Chief: Dr. Leslye Johnson

\(301\) 496-7051, Fax: (301) 402-1456

Email: <lj7m@nih.gov>

C. ***[Parasitology and International Programs Branch.]{.underline}***
Research areas: (1) protozoal infections, amebiasis, cryptosporidiosis,
cyclosporiasis, giardiasis, leishmaniasis, malaria, trypanosomiasis,
toxoplasmosis, Helminth infections, cysticercosis, lymphatic filariasis,
schistosomiasis, onchocerciasis, others (e.g., roundworms, tapeworms,
and flukes), Invertebrate vectors/ectoparasites, blackflies, mosquitoes,
ticks, snails, mites; (2) parasite biology (genetics, genomics,
physiology, and biochemistry); (3) protective immunity,
immunopathogenesis, evasion of host responses; (4) clinical and
epidemiologic studies of the natural history of parasitic diseases; (5)
research and development of vaccines, drugs, immunotherapeutics, and
medical diagnostics, and (6) vector biology and control; mechanisms of
pathogen transmission.

Chief: Dr. Lee Hall

\(301\) 496-2544, Fax: (301) 402-0659

Email: <lhall@niaid.nih.gov>

D. ***[Respiratory Diseases Branch.]{.underline}*** Research areas: (1)
viral respiratory diseases, including those caused by: coronaviruses
(including SARS), orthomyxoviruses (including influenza A, B and C), and
paramyxoviruses (including parainfluenza viruses and respiratory
syncytial virus); (2) bacterial respiratory diseases, including those
caused by Moraxella catarrhalis (chronic obstructive pulmonary disease),
Pseudomonas aeruginosa and Burkholderia cepacia (associated with cystic
fibrosis), Corynebacterium diphtheriae (diphtheria), groups A and B
streptococci, Haemophilus influenzae, Neisseria meningitidis, Bordetella
pertussis (pertussis), Streptococcus pneumoniae, Mycoplasma pneumoniae,
Chlamydia pneumoniae and Klebsiella pneumoniae; (3) Otitis media; (4)
mycobacterial diseases, including those caused by: M. tuberculosis
(tuberculosis), multi-drug resistant M. tuberculosis, M. leprae
(leprosy), and M. ulcerans and other non-tuberculous mycobacterial
diseases; (5) development and licensure of vaccines and therapeutic
agents for treating and preventing respiratory diseases; (6) maternal
immunization; (7) basic research on the pathogenesis, immunity,
structural biology, molecular genetics, and genomics of respiratory
pathogens; (8) epidemiology and natural history of respiratory
pathogens; (9) development of better and more rapid medical diagnostics;
and (10) understanding the etiology and long-term health impact of
respiratory pathogens in various populations.

Contact: Dr. Gail Jacobs

\(301\) 496-5305, Fax: (301) 496-8030

Email: <gjacobs@niaid.nih.gov>

E. ***[Sexually Transmitted Infections Branch.]{.underline}***
Development of medical diagnostics, drugs, topical microbicides, and
vaccines for sexually transmitted infections (STIs) and other
reproductive tract syndromes, such as bacterial vaginosis; molecular
immunology; vaginal ecology and immunology; epidemiologic and behavioral
research; genomics and proteomics of sexually transmitted pathogens;
adolescents and STIs; STIs and medically underserved populations and
minority groups; STIs and infertility and adverse outcomes of pregnancy;
role of STIs in HIV transmission; role of HIV in altering the natural
history of STIs; and other sequellae of STIs.

Contact: Elizabeth Rogers

\(301\) 451-3742, Fax: (301) 480-3617

Email: <erogers@niaid.nih.gov>

F. ***[Virology Branch.]{.underline}*** Acute viral infections and
zoonoses, dengue and other arthropod-borne viral diseases
(mosquito-borne encephalitis, including West Nile, yellow fever, etc.),
hantaviruses, hemorrhagic fevers (Ebola, Lassa, South African
hemorrhagic fevers, etc.), measles, polio, coxsackie virus, and other
enteroviruses, poxviruses, rabies, rubella; persisting viral diseases
and viruses: adenoviruses, bornaviruses, coronaviruses, herpesviruses,
parvoviruses, prion diseases; emergence of viral disease; mechanisms of
replication, permissiveness, persistence, and latency; vaccines; immune
protection and evasion and viral vectors; epidemiology and viral
evolution; structure and function of viruses and viral proteins;
molecularly targeted approaches to identify and characterize antiviral
targets and agents; chemical design and synthesis of novel antiviral
agents; in vitro screening and evaluation of antiviral activity;
preclinical therapeutic and some prophylactic evaluations of human viral
infections in animal models; clinical trials of vaccines and therapies
for viral infections; research of civilian defenses for potential
bioterrorist use of viruses; and development of rapid medical diagnostic
systems. The Virology Branch does not support applications covering
environmental detection and decontamination.

Chief: Dr. Catherine A. Laughlin

\(301\) 496-7459, Fax: (301) 402-0659

Email: <cl28r@nih.gov>

[]{#__RefHeading___Toc124236900 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Dr. Gregory Milman

National Institute of Allergy and Infectious Diseases

\(301\) 496-8666, Fax: (301) 402-0369

Email: <gmilman@niaid.nih.gov>

For administrative and business management questions, contact:

Ms. Mary Kirker

Grants Management Officer

National Institute of Allergy and Infectious Diseases

\(301\) 496-7075, Fax: (301) 480-3780

Email: <mk35h@nih.gov>

[]{#__RefHeading___Toc124236901 .anchor}National Institute of Arthritis
and Musculoskeletal and Skin Diseases (NIAMS)

The NIAMS supports research in arthritis and musculoskeletal and skin
diseases. Such research is directed at basic understanding of the causes
and development of rheumatic diseases, connective tissue diseases,
musculoskeletal and skin disorders and diseases. Basic investigations
involve immunology; purine metabolism; skeletal muscle structure,
function, metabolism and physiology; the structure, function,
production, biochemistry and physiology of collagen, elastin, and other
proteins of connective tissue; metabolic and hormonal changes in bone;
prevention and treatment strategies for osteoporosis and related bone
diseases, structural and biochemical changes in osteoarthritic cartilage
and cartilage repair; novel imaging modalities for bone, cartilage, and
connective tissues; new treatments for fractures and other
musculoskeletal tissues including tissue engineering and gene therapy;
orthopaedic implant science (materials, design, wear, osteointegration);
bioimaging of musculoskeletal tissues; computer-assisted orthopaedic
surgery and other computer-assisted musculoskeletal bioimaging and
treatment interventions; the biomechanics of normal, arthritic and
prosthetic joints; the structure, function, barrier properties,
metabolism, and physiology of the skin. Exercise research related to
musculoskeletal function, including the development of tools or behavior
modification programs to enhance exercise in normal individuals or those
with chronic diseases, and related behavioral and prevention research.

For additional information about areas of interest to the NIAMS, please
visit our home page at
[http://www.niams.nih.gov](http://www.niams.nih.gov/).

[]{#__RefHeading___Toc124236902 .anchor}Arthritis and Musculoskeletal
and Skin Diseases

A. ***[Rheumatic Diseases Branch.]{.underline}*** Supports basic and
clinical research in the normal function and components of connective
tissue and the immune system and their dysregulation in rheumatic,
genetic, and inherited diseases of connective tissue. The goals are
increased understanding of the etiology and pathogenetic mechanisms
involved in rheumatic and degenerative disease of the joints and in the
translation of these basic research findings to prevention, diagnosis,
and treatment of disease. The research supported by the Program utilizes
approaches emanating from relevant areas of genetics, biochemistry,
cellular and molecular biology, biophysics, enzymology, immunology,
pathology, physiology, behavioral medicine, and epidemiology.

A description of other areas of research under investigation may be
found at [http://www.niams.nih.gov/rtac/funding/grants/
ep3.htm](http://www.niams.nih.gov/rtac/funding/grants/ep3.htm).

B. ***[Musculoskeletal Diseases Branch.]{.underline}*** Supports studies
of the skeleton and associated connective tissues. Research areas
supported through the Musculoskeletal Diseases Branch include bone
diseases, bone biology, and orthopaedic research. Broad areas of
interest include skeletal development, metabolism, mechanical
properties, and responses to injury. Osteoporosis, a disease afflicting
many of the Nation\'s growing population of older people, is
particularly emphasized for investigation under this program. Among
other diseases and skeletal disorders under investigation are
osteogenesis imperfecta, a genetic disorder that leads to fragile,
easily fractured bones; Paget\'s disease of bone, which results in
irregular bone formation and subsequent deformity; genetic disorders of
bone growth and development, such as osteopetrosis and the
osteochondrodysplasias; vitamin D refractory diseases; and rickets and
osteomalacia. Other studies focus on the causes and treatment of acute
and chronic injuries, including carpal tunnel syndrome, repetitive
stress injury, low back pain and clinical and epidemiological studies of
osteoarthritis. The Program supports development of new technologies
with the potential to improve treatment of skeletal disorders and
facilitate the repair of trauma in the normal skeleton. These include
drugs and nutritional interventions, joint replacement, bone and
cartilage transplantation, and gene therapy. In addition,
bioengineering, sports medicine and musculoskeletal fitness are areas of
special research emphasis.

A description of other areas of research under investigation may be
found at [http://www.niams.nih.gov/rtac/funding/grants/
ep5.htm](http://www.niams.nih.gov/rtac/funding/grants/ep5.htm).

C. ***[Skin Diseases Branch.]{.underline}*** Supports basic and clinical
studies of the skin in normal and disease states. The wide range of skin
diseases under study with NIAMS support includes keratinizing disorders
such as psoriasis and ichthyosis, atopic dermatitis and other chronic
inflammatory skin disorders, the vesiculobullous diseases such as
epidermolysis bullosa and pemphigus, acne, and vitiligo.

A description of other areas of research under investigation may be
found at: [http://www.niams.nih.gov/rtac/funding/grants/
ep6.htm](http://www.niams.nih.gov/rtac/funding/grants/ep6.htm).

1\. Determinations of drug effects.

2\. Determinations of effects of other therapies, including occupational
and physical therapy modalities, spinal manipulation, bracing,
transcutaneous nerve stimulation, acupuncture, and topical agents (e.g.,
capasicin).

3\. Preventive strategies.

4\. Development and validation of animal models for rheumatic,
musculoskeletal (especially for herniated intervertebral disc and spinal
stenosis), muscle and skin diseases.

5\. Improvement and refinement of immunogenetic determinants of
rheumatic diseases.

6\. Development of novel and improved diagnostic methods and treatments
for muscle, tendon, ligament, bone, and joint injuries, including
overuse and repetitive motion disorders.

7\. Devices and activities designed to prevent muscle, tendon, ligament,
and joint injuries, including overuse and repetitive motion disorders.

8\. Assessment techniques for musculoskeletal and skin diseases.

9\. Functional and metabolic measures of the musculoskeletal system in
normal, diseased and active states.

10\. Development of novel implant designs, materials and surface
coatings for musculoskeletal implants. Development of assessment
strategies to detect implant failure, loosening, and osteolysis, and the
development of novel technologies to prevent them.

11\. Computer modeling, relevance to the musculoskeletal system.

12\. Improved topical treatments of skin diseases and disorders.

13\. Devices and computer programs for diagnosis or assessment of skin
diseases.

14\. Tissue culture models for skin diseases.

15\. Artificial skin.

16\. Photoprotective agents.

17\. Improved treatment for bone diseases.

18\. Measurement techniques for bone diseases.

19\. Preventive measures for fractures.

20\. Delivery systems for dietary supplements.

21\. Novel delivery systems for therapeutic agents.

22\. Development of novel or improved technologies for bone healing and
repair. This includes, but is not limited to, the development of
osteoinductive, osteoconductive, or a combination, technologies to
facilitate bone healing/repair, and the development of improved or novel
approaches to the use of autogenous, allograft, and bone graft
substitutes.

23\. Development of novel or improved technologies to facilitate the
repair of articular cartilage, including, but not limited to cartilage
cell transplantation, use of stem cells, biodegradable scaffolds, growth
factors, and refinements of currently existing technologies.

24\. Development of novel technologies to improve the diagnosis,
prevention, and treatment of acute and chronic low back pain.

25\. Development of novel assessment technologies for identifying
biomechanical inputs on bone and cartilage tissue at the cellular level,
and identification of the corresponding physiological response.

26\. Development of novel technologies leading to the use of gene
therapy for selected musculoskeletal diseases and injuries.

27\. Development of novel, non-invasive technologies to assess joint
tissues, including articular cartilage and subchondral bone.

[]{#__RefHeading___Toc124236903 .anchor}Markers of Osteoarthritis

The NIAMS seeks applications for the development and validation of
standardized, sensitive assays for osteoarthritis markers in body fluids
or tissue specimens. Osteoarthritis is the most prevalent
musculoskeletal disorder, characterized by joint pain, tenderness, and
functional disability. The percentage of Americans over 65 years of age
is the fastest growing segment of the population, which is expected to
reach 68 million people by the year 2010. A biochemical test for
osteoarthritis would be particularly useful for early detection,
assessment of disease severity and progression, and to monitor the
effects of therapies.

Advances in the molecular biology, biochemistry, and metabolism of
cartilage have stimulated the quest for appropriate markers of
degradative and regenerative processes in osteoarthritis. Important new
studies indicate that molecular fragments of cartilage-derived matrix
molecules are present in the blood and joint fluid in osteoarthritis
that have the potential to represent disease-specific markers. The
increased rates of cartilage degeneration increase the concentration of
matrix components in tissue and body fluids, thus reflecting changes in
the rates of cartilage catabolism. Further, cartilage degeneration in
osteoarthritis changes the type or structure of the molecules being
synthesized by the chondrocytes. Thus, the presence of these
neo-epitopes may be a marker of degenerative events within the tissue.
Markers of metabolic changes in subchondral bone or other joint tissues
in osteoarthritis are also be of potential interest.

The NIAMS is soliciting applications to test the potential application
of a marker for osteoarthritis diagnosis, prognosis or severity and the
standardization of a clinically relevant test. Successful applicants
will provide a rational approach for the development of a practical and
reliable assay for osteoarthritis disease marker(s) and determination of
the sensitivity and specificity of the marker(s) in patient populations.
The applications must include the rationale for the selection of the
marker to be employed in the study. If a battery of markers will be
utilized the basis of this approach must be clear and well justified.
The assay systems as well as the methods of sample collection, storage,
and handling must be clearly delineated. Marker levels must be validated
against other methods of monitoring osteoarthritis, such as imaging
techniques. The expected outcome of these studies is an osteoarthritis
test that can be used in larger scale human trials.

[]{#__RefHeading___Toc124236904 .anchor}Muscle Biology, Exercise
Physiology and Sports Medicine

A. ***[Muscle Biology Branch.]{.underline}*** Supports research on
skeletal muscle, its diseases and disorders, and its central role in
human physiology and exercise. Topics include the molecular structure of
muscle and the molecular mechanisms that produce force and motion. An
aim is understanding the alterations in muscle resulting from increased
exercise regimens and, conversely, the atrophy that follows
immobilization during injury or illness. Some of the specific areas of
research covered by the Muscle Biology Branch include Muscle Physiology,
Molecular Architecture, Muscle Membranes, Muscle Development and
Specialization, Musculoskeletal Fitness and Adaptive Biology, Muscle
Diseases, and Sports Medicine, Muscle Injury and Muscle Repair. Areas
that may be of interest to small businesses include but are not limited
to:

1\. Muscle Structure and Function.

Research on the application of biochemistry, molecular, and cell biology
to muscle biology, including studies of membrane structure, function,
and biosynthesis, lipid metabolism, membrane models, membrane transport,
sub-cellular organization, organelles, cytoskeletal components, and cell
division. Development of new instruments and methods to facilitate
studies on muscle function and physiology. Specific examples might
include, but are not limited to, the following:

a\. Development of methods and materials directed toward the solution of
muscle cytoskeletal and membrane protein structures by x-ray
diffraction, electron diffraction, and NMR spectroscopy.

b\. New methods for the purification and reconstitution of muscle
membrane proteins.

c\. Development of monoclonal and/or recombinant antibodies to
cytoskeletal and membrane proteins exhibiting high specificity and
affinity and broad cross-species reactivity.

2\. Muscle Fitness and Sports Medicine.

a\. Improve measurement of muscle strength and balance, including
refined instrumentation for biomechanical assessment of normal movement
and posture.

b\. Develop quantitative methods of assessing postural perturbations and
forces relevant to activities of daily living.

c\. Improve imaging and analytical techniques to measure skeletal muscle
properties, (e.g., through MRI Imaging and Spectroscopy).

d\. Imaging techniques which allow simultaneous imaging of muscle
morphology and metabolism and blood flow.

e\. Development of novel assays or modifications of currently existing
assay of muscle metabolism for use with human biopsy samples.

f\. Develop biosensors to detect changes in pressure, temperature, or
physiological parameters associated with muscular activity.

g\. Development of treatments for wound healing and improve general
understanding of the natural healing process for muscle.

h\. Develop antioxidant interventions to prevent oxidative damage during
muscle use and overuse.

i\. Develop cell culture models for rapid testing of treatments for
muscle injury and wasting.

3\. Development and Genetic Diseases.

a\. Develop animal models that mimic the pathophysiology of the genetic
human muscle diseases.

b\. Develop gene vectors (viral and non - viral), promoter and enhancer
elements and related methodologies that could be used for in vivo and ex
vivo gene therapy for muscular diseases.

c\. Develop cell lines and tissue cultures for replacement of muscle
that has been damaged or destroyed.

d\. Develop markers for muscle satellite cells and use them to
characterize availability for muscle repair.

e\. Develop techniques, equipment, and software to enable improved
imaging of muscle development and specialization.

A description of other areas of research under investigation may be
found at: [http://www.niams.nih.gov/rtac/funding/grants/
ep4.htm](http://www.niams.nih.gov/rtac/funding/grants/ep4.htm).

[]{#__RefHeading___Toc124236905 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

*[Genetics and Clinical Studies]{.underline}*

Dr. Susana Serrate-Sztein

National Institute of Arthritis and Musculoskeletal and Skin Diseases

\(301\) 594-5032, Fax: (301) 480-4543

Email: <ss86e@nih.gov>

*[Immunology and Inflammation]{.underline}*

Dr. Elizabeth Gretz

National Institute of Arthritis and Musculoskeletal and Skin Diseases

\(301\) 594-5032, Fax: (301) 480-4543

Email: <gretze@mail.nih.gov>

*[Cartilage and Connective Tissue]{.underline}*

Dr. Bernadette Tyree

National Institute of Arthritis and Musculoskeletal and Skin Diseases

\(301\) 594-5032, Fax: (301) 480-4543

Email: <bt16w@nih.gov>

*[Behavioral and Prevention Research]{.underline}*

Dr. Deborah Ader

National Institute of Arthritis and Musculoskeletal and Skin Diseases

\(301\) 594-5032, Fax: (301) 480-4543

Email: <aderd@mail.nih.gov>

*[Muscle Biology]{.underline}*

Dr. Richard Lymn

National Institute of Arthritis and Musculoskeletal and Skin Diseases

\(301\) 594-5128, Fax: (301) 480-4543

Email: <rl28b@nih.gov>

*[Skin Diseases]{.underline}*

Dr. Alan N. Moshell

National Institute of Arthritis and Musculoskeletal and Skin Diseases

\(301\) 594-5017, Fax: (301) 480-4543

Email: <am40j@nih.gov>

*[Orthopaedics]{.underline}*

Dr. James Panagis

National Institute of Arthritis and Musculoskeletal and Skin Diseases

\(301\) 594-5055, Fax: (301) 480-4543

Email: <jp149d@nih.gov>

*[Bone Biology]{.underline}*

Dr. William Sharrock

National Institute of Arthritis and Musculoskeletal and Skin Diseases

\(301\) 594-5055, Fax: (301) 480-4543

Email: <ws19h@nih.gov>

*[Bone Diseases]{.underline}*

Dr. Joan McGowan

National Institute of Arthritis and Musculoskeletal and Skin Diseases

\(301\) 594-5055, Fax: (301) 480-4543

Email: <jm106v@nih.gov>

*[Osteoarthritis Initiative and Diagnostic Imaging]{.underline}*

Dr. Gayle Lester

National Institute of Arthritis and Musculoskeletal and Skin Diseases

\(301\) 594-5055, Fax: (301) 480-4543

Email: <lester1@mail.nih.gov>

For program information, contact:

Dr. Cheryl Kitt

National Institute of Arthritis and Musculoskeletal and Skin Diseases

\(301\) 594-2463, Fax: (301) 480-4543

Email: <kittc@mail.nih.gov>

For administrative and business management questions, contact:

Ms. Melinda Nelson

National Institute of Arthritis and Musculoskeletal and Skin Diseases

\(301\) 435-5278, Fax: (301) 480-5450

Email: <mn23z@nih.gov>

[]{#__RefHeading___Toc124236906 .anchor}National Institute of Biomedical
Imaging and Bioengineering (NIBIB)

The NIBIB supports hypothesis-, design-, technology- or problem-driven
research relating to the discovery, design, development, translation and
assessment of new knowledge in biomedical imaging and bioengineering.
This research may utilize, for example, an organ or disease as a model
system for development purposes. Also, several Institutes or Centers may
collaborate on research of mutual interest.

For additional information about areas of interest to the NIBIB, please
visit our home page at (<http://www.nibib.nih.gov/>). This site includes
staff contact information by program area
(<http://www.nibib.nih.gov/about/directory/program_staff_areas.html>).
It also includes links to program announcements and requests for
applications that highlight NIBIB areas of special emphasis ([http://
www.nibib.nih.gov/research/investigators.htm](http://www.nibib.nih.gov/research/investigators.htm)).
In some cases, these announcements specifically mention the SBIR and
STTR grant mechanisms, in other cases they do not. However, it is clear
that small businesses could make contributions to the research
objectives described in many of these announcements.

NIBIB Extramural Science Programs support research and training in
various areas of biomedical imaging and bioengineering.

Biomedical Imaging research supported by the NIBIB includes imaging
device development, biomedical imaging technology development, image
processing, imaging agent and molecular probe development, informatics
and computer sciences related to imaging, molecular and cellular
imaging, bioelectrics/biomagnetics, organ and whole body imaging,
screening for diseases and disorders, and imaging technology assessment.
Areas that may be of interest to small businesses include, but are not
limited to:

A. Development of imaging devices for evaluation of all levels of
biological material from single-copy (oligonucleotides or proteins) to
whole body, particularly development of small animal imaging models.

B. Development of improved imaging techniques in the areas of spatial
and temporal resolution, speed of information acquisition, detectors,
and contrast resolution.

1\. Development of new methods for obtaining accurate, 3-dimensional
depth dose information for radiography.

2\. Development of new display technologies for digital imaging systems
and methods for their characterization/assessment.

C. Development of methods that increase the information obtained from
images.

1\. Development of image reconstruction algorithms and image
pre-processing methods.

2\. Development of new techniques or application of existing techniques
(e.g., image segmentation, registration, or filtering) to gain
additional data from images.

D. Application of informatics and computer sciences to imaging.

1\. Development of new and effective strategies for classification and
estimation, using synthesis and integration of multimodal imaging and
modeling approaches with a priori information.

2\. Integration of information content from diverse imaging methods and
databases for diagnostic application.

E. Development of improved organ and whole body image resolution and
data display while maintaining or improving minimization of
invasiveness, imaging and processing time, costs, and patient
discomfort.

F. Establishment of novel imaging techniques to pinpoint signifying
events that mark disease onset and define its biologic characteristics.

Bioengineering research supported by the NIBIB includes biomaterials,
biomechanics and rehabilitation engineering, tissue engineering, medical
devices and implant science, therapeutic agent delivery systems,
biosensors, platform technologies, nanotechnology, mathematical models
and computation algorithms, bioinformatics and medical informatics,
remote diagnosis and therapy, image-guided interventions, and surgical
tools and techniques.

Although not exhaustive, topics of interest for SBIR and STTR
applications may include the following:

A. Development of biomaterials. Development of novel materials to mimic
structural features of biological systems by incorporation of an
understanding of natural systems. Development of biomaterials that
incorporate biomechanical design features.

B. Application of biomechanics for the continued improvement in the
design and development of implants, prostheses, and artificial organs.

C. Development of fabrication techniques including synthesis or milling
techniques, controlled and designed crystallization methods, large-scale
methods suitable for manufacturing purposes, controlled particle
aggregation, and nanoparticle coating techniques.

D. Development of functional tissue or organ substitutes in vitro for
implantation in vivo, or to remodel and regenerate tissue in vivo for
the purpose of repairing, replacing, maintaining, or enhancing organ
function.

E. Development of substrates or scaffolds for tissue growth and
differentiation.

F. Development of material science methods for combinatorial chemistry.

1\. Development of paradigms and techniques based on combinatorial
approaches for the design, synthesis, characterization, assay, and
end-use evaluation of complex, novel molecular entities and
interactions.

2\. Develop of analysis tools that complement combinatorial approaches,
including high throughput screening, chemical analysis, and biological
assay.

3\. Development of tools for information management and dissemination to
cope with the large amount of data generated by combinatorial
approaches.

G. Development of improved implant surfaces and interface processes.
Development of techniques that can follow depositions on biomaterial
surfaces in vitro and in real time.

H. Development of improved biosensor technology including the design,
fabrication, and characterization of non-fouling sensors to be used in
biomedical research and medicine. Development of algorithms or equations
that relate the biosensor transducer measurement to biologically or
medically relevant information.

I. Application of nanoscience derived principles toward the development
of nanoscale components or biomolecular processes in diagnostic and
therapeutic devices.

J. Design and construction of engineered nanosystems that may utilize
biological or biologically inspired elements. Implementation and
delivery of nanoscale tools for the diagnosis and treatment of disease
or to interface with specific tissues to improve function.

K. Development of new targeted and systemic drug and gene delivery
systems to enhance the delivery, selectivity, and therapeutic effects of
agents.

L. Development of algorithms, mathematical models, simulations and
analysis of complex biological, physiological, and biomechanical
systems.

M. Development of new techniques to collect and store quantitative data
ranging from the genome to the organism and to elucidate functional
dynamics in living cells and tissues with sensitivity down to the level
of single molecules.

N. Development of methods to support the transfer and application of
population-based health information in clinical settings.

O. Development of methods for structuring, managing, and analyzing
large, distributed, networked, adaptive databases.

P. Development of visualization standards for 3-D image acquisition, for
visualization parameters to categorize various tissues in 3-D models and
for interpreting 3-D images.

Q. Development of new minimally invasive surgical tools and techniques,
as well as techniques for tracking and placement of surgical tools in a
stereotactic space.

R. Development of new medical technologies, including image-guided
therapies, computer-assisted surgeries, and large-scale simulation
modeling to improve surgical outcome.

S. Development of novel telehealth instrumentation or technologies that
provide and support health care at a distance and can be applied to a
broad spectrum of disorders and diseases.

[]{#__RefHeading___Toc124236907 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Mr. Todd Merchak

National Institute of Biomedical Imaging and Bioengineering

\(301\) 496-8592, Fax: (301) 480-1614

Email: <merchakt@mail.nih.gov>

For administrative and business management questions, contact:

Ms. Florence Turska

National Institute of Biomedical Imaging and Bioengineering

\(301\) 496-9314, Fax: (301) 480-4974

Email: <turskaf@mail.nih.gov>

[]{#__RefHeading___Toc124236908 .anchor}National Cancer Institute (NCI)

In its attempt to eliminate suffering and death due to cancer by 2015,
the National Cancer Institute promotes research that crosses the
discovery, development, and delivery continuum and that addresses
barriers to progress, forging partnerships, opening access to datasets
and tissue resources, and more fully utilizing emerging technologies in
genomics, proteomics, communications, and delivery of clinical and
public health interventions. To achieve these goals, NCI seizes
extraordinary scientific opportunities and creates and sustains funding
mechanisms that support translational research.

NCI's SBIR and STTR programs focus on research, development and delivery
and are critical to achieving the institute's goals. Research
opportunities cited below are not all inclusive; those listed are
"open-ended" to encourage submission of innovative projects that fit
NCI's mission. For additional information, access the NCI homepage:
<http://www.cancer.gov/> and
<http://otir.nci.nih.gov/smallbusiness/small_sbir.html> .

[]{#__RefHeading___Toc124236909 .anchor}Center to Reduce Cancer Health
Disparities

Established in March 2001, CRCHD is the cornerstone of the Institute's
efforts to reduce the unequal burden of cancer in our society. A central
goal of the Center is to translate research discoveries into policies
and/or services aimed at reducing cancer-related health disparities in
racial, ethnic, elderly and medically underserved communities. To learn
more about the Center, please visit our website:
[http://crchd.nci.nih.gov](http://crchd.nci.nih.gov/).

The Center is interested in the following SBIR/STTR applications:

A. ***[Communication.]{.underline}*** Training tools to help health
professionals deal with issues concerning health literacy and cultural
competency.

B. ***[Health Care and Epidemiology.]{.underline}*** Computer software
and hardware for hand-held data input and analysis devices; databases
and other tools to study patterns of cancer care in underserved
communities.

C. ***[New Technology.]{.underline}*** Instrumentation to facilitate
early detection and screening, including telemedicine and remote medical
imaging, and bioengineering technology (including nanotechnology)
applied to cancer detection and diagnosis in underserved communities.

D. ***[Geographic Information Systems.]{.underline}*** Simple, low-cost
mapping software to overlay cancer patterns with socioeconomic data,
health system infrastructure, healthcare, personal behaviors, ethnicity,
risk factors, and consumer profiling among underserved communities.

E. ***[Human Genomics.]{.underline}*** Tools and technology for health
care providers using cancer research developments from genomics,
pharmaco-genetics and proteonomics for underserved populations.

For additional information, please email our SBIR/STTR Program Director
at <Taylorem@mail.nih.gov>.

[]{#__RefHeading___Toc124236910 .anchor}Division of Cancer Biology

The Division of Cancer Biology (DCB) plans and directs, coordinates, and
evaluates a grant- and contract-supported program of extramural basic
and applied research on cancer cell biology and cancer immunology, and
cancer etiology, including the effects of biological, chemical and
physical agents, in the promotion of cancer; maintains surveillance over
developments in its program and assesses the national need for research
in cancer biology, immunology and etiology; evaluates mechanisms of
biological, chemical and physical carcinogenesis and subsequent tumor
growth and progression to metastasis; tests for carcinogenic potential
of environmental agents; serves as the focal point for the Federal
Government on the synthesis of clinical, epidemiological and
experimental data concerning biological agents relating to cancer; and
maintains the necessary scientific management capability to foster and
guide an effective research program. For additional information, please
visit our home page at <http://www.nci.nih.gov/dcb/dcbhom.htm>.

A. ***[Cancer Cell Biology.]{.underline}*** The Cancer Cell Biology
Branch (CCBB) seeks to understand the biological basis of cancer at the
cellular and molecular level. This research utilizes lower eukaryote and
animal models, and animal and human tumor cells and tissues to analyze
the mechanisms responsible for the growth and progression of cancer.
Specific research and technologies supported by CCBB in this
solicitation include but are not limited to the following:

1\. Development of novel methods and tools to study key aspects of
programmed cell death including its regulation and modulation.

2\. Development of methods to identify and isolate tissue-specific stem
cells.

3\. Development of markers associated with specific cellular processes
or differentiation.

4\. Development of novel techniques, tools, and vectors to transfer
functional genes, proteins, antibodies, etc. into intact cells or
organisms.

5\. New or improved technologies for the efficient microdissection of
tumor tissue sections to isolate and preserve human cancer cells
appropriate for research.

6\. Development of human tumor cDNA library banks to study gene
expression in cancer.

7\. Development and distribution of genomic resources suitable for
genomic manipulation or cytogenetic studies.

8\. Generation of new or improved animal models or non-mammalian models
(e.g. flies, worms) as research tools to study human cancers.

9\. Generation of new inbred genetic animal models that transmit
defective or altered cancer-related genes.

10\. Development of novel technologies, methodologies, tools, or basic
instrumentation to facilitate basic cancer research (research tools).

11\. Development of methods and tools to study processes of protein
trafficking, post-translational modification, and degradation.

12\. Development of novel methods and tools for the analysis of
intracellular organelles.

13\. Development of novel methods and tools to determine intracellular
gradient status.

14\. Improved extraction methodologies and tools for tumor specimens for
the subsequent analysis of DNA, RNA, and proteins.

15\. Development of new or improved methods to isolate intact cellular
regulatory complexes.

16\. Development of novel methods and tools to examine key cellular
communication pathways.

B. ***[Cancer Etiology.]{.underline}*** The Cancer Etiology Branch (CEB)
supports research that seeks to determine the role of chemical, physical
and biological agents as factors or cofactors in the etiology of human
and animal cancer. The biological agents of primary interest are DNA
viruses, RNA viruses, AIDS and AIDS-associated viruses, although the
research may encompass all forms of life including bacteria and other
microbial agents associated with cancer and use animal models of cancer
and cancer vaccines. Chemical Carcinogenesis studies are concerned with
cancers initiated or promoted by chemical or physical agents. A wide
range of approaches are supported, including studies of the genetics of
cell transformatioin, mutagenesis, tumor promotion and DNA damage, as
well as studies of basic biochemistry and molecular biology of oncogenic
and suspected oncogenic agents, viral oncogenes and associated tumor
suppressor genes, pathogenesis and natural history studies, animal
models, and preventive vaccine research. Mechanistic studies are
encouraged in areas such as metabolism, toxicity and physiological
distribution of carcinogens, genetics and regulation of enzymes,
biochemical and molecular markers, and organ and cell culture systems
and animal models. Also of interest are studies on cancer etiology by
environmental chemicals, tobacco consumption and exposure, nutritional
hazards, alcohol, asbestos, silica, and man-made fibers. CEB supports
studies on endogenous exposure to steroid hormones and the generation of
oxygen radicals during normal metabolism, studies on phytoestrogens and
xenoestrogens and their impact on the metabolism of endogenous
estrogens. In addition, CEB supports the development of analytical
technologies to facilitate studies relating to carcinogenesis and
mutagenesis. Specific research and technologies supported by CEB in this
solicitation include but are not limited to the following:

1\. Development of reagents, probes, and methodologies to evaluate the
etiologic role of oncogenic viruses and other microbial agents (such as
bacteria) in human cancer.

2\. Development of novel in vitro culture techniques for oncogenic
viruses or other microbial agents associated with or suspected of
causing human cancer.

3\. Development of sensitive, simplified diagnostic kits or reagents for
the detection of oncogenic viruses or other microbial agents.

4\. Development and characterization of animal models for studies of the
mechanism of cancer induction by viruses or other microbial agents. The
animals should faithfully mimic the human diseases associated with the
virus or other microbial agent.

5\. Development of methods (e.g., new-anti-microbial compounds, new
vaccine approaches) to avert the induction of neoplasia in humans and
animals by oncogenic viruses or bacteria.

6\. Development of other novel technologies, methodologies or
instrumentation to determine the role of biological agents, especially
viruses, in the etiology of cancer.

7\. Development and validation of methods for food treatment,
preparation, or processing that will reduce or eliminate
carcinogen/mutagen content.

8\. Development of rapid analytical techniques for the qualitative and
quantitative detection and screening of xenobiotics, chemical
contaminants, and carcinogens/mutagens in human foods and biological and
physiological specimens.

9\. Development of in vitro and in vivo models for basic studies of
carcinogenesis in specific organ systems, such as the pancreas,
prostate, ovary, central nervous system, kidney, endometrium, stomach,
and upper aerodigestive tract.

10\. Development of methods for the production of carcinogens,
anticarcinogens, metabolites, biomarkers of exposure, oxidative damage
markers, and DNA adducts, both labeled and unlabeled, which are neither
currently available commercially nor offered in the NCI Chemical
Carcinogen Reference Standard Repository. The production of these
compounds, in gram quantities, is desired for sale/distribution to the
research community.

11\. Development of methods for detection, separation, and quantitation
of enantiomeric carcinogens, metabolites, adducts, and biomarkers of
carcinogen exposure.

12\. Development of monoclonal antibodies that are specific for
different carcinogen-nucleoside adducts and demonstration of their
usefulness in immunoassays. Of particular interest are antibodies to
alpha-beta unsaturated carbonyl compounds (such as acrolein and
crotonaldehyde) which can form exocyclic nucleoside adducts with DNA,
and immunoassays for carcinogen/protein adducts as potential biomarkers
of exposure.

13\. Development of immunoassays using monoclonal antibodies that are
specific for different polymorphs of Phase I and II
carcinogen-metabolizing enzymes and repair enzymes. Included, but not
limited to, are antibodies to the cytochrome P450 isozymes, glutathione
S-transferases, and N-acetyl transferases.

14\. Development of rapid, sensitive, and quantitative assays for the
identification and measurement of androgens, estrogens, phytoestrogens,
and xenoestrogens in complex biological matrices.

15\. Development of rapid analytical techniques for the direct
measurement of ligand-protein receptor interactions and determination of
binding coefficients.

16\. Development of analytical instrumentation for the detection and
quantitation of extremely low levels of Tritium (3H) or 3H and Carbon-14
(14C) from biological samples. Of particular interest is the development
of small-sized, accelerator-based mass spectrometry equipment capable of
measuring down to, or below, contemporary background levels of 3H and
14C that would make this sensitive technique more widely available to
research groups. The design and development of technologically improved
and miniaturized individual components, including ion source, sample
preparation (autosampling apparatus), accelerator, and mass
spectrometric detectors, are also solicited.

17\. Synthesis of selective suicide inhibitors of cytochrome P450
isoforms and selective arachidonic acid pathway inhibitors/ enhancers
for basic biochemical studies and anticarcinogenic potential.

18\. Development of invertebrate animal models (such as Drosophila, C.
elegans, clam, and sea urchin) for the study of environmental chemicals
and/or hormonal carcinogenesis.

19\. Development of more efficient and reliable methods of preserving
valuable animal model gene stocks by innovative in vitro techniques.

20\. Development of a defined diet for support and maintenance of
aquatic and marine fish models of cancer including but not limited to
swordtail, zebrafish, medaka, mummichog, guppy, Fugu, and Damselfish.

21\. Development of serum free tissue culture media for aquatic and
marine fish models of cancer.

C. ***[Cancer Immunology and Hematology.]{.underline}*** The Cancer
Immunology and Hematology Branch (CIHB) supports a broad spectrum of
basic research focused on the earliest stages of hematopoiesis and
tracing the molecular events that lead to the development of all the
functional elements of the immune system and, when errors occur, to the
development of leukemias and lymphomas. Most research of interest falls
into three major areas. The first is the immune response to tumors to
include studies of all of the cells (T, B, NK, antigen-presenting, and
other myeloid cells) and secreted molecules (antibodies and cytokines)
of the immune system that can recognize and affect tumor growth.
Emphasis is placed on the regulatory mechanisms responsible for the
failure of immune response to eradicate most tumors under normal
conditions, and the development of strategies to circumvent these
mechanisms. A second major area of interest examines the biology of
hematopoietic malignancies to describe the detailed reasons underlying
cell\'s failure to respond to normal growth controls and to develop
novel approaches to prevention or therapy. The third distinct area
supported is the basic biology of bone-marrow transplantation, including
studies of host cell engraftment, graft-versus-host disease, and the
basis of the graft-versus-leukemia effect. Specific research and
technologies supported by CIHB in this solicitation include but are not
limited to the following:

1\. Development of improved or novel monoclonal antibody technologies
including improvements of methodologies for fusion, production of novel
cells as fusion partners, selection and assay of antibody producing
clones, and production of new and improved monoclonal antibodies.

2\. Synthesis, structure and function of antibodies capable of reacting
with tumor cells, agents that induce tumors, agents used in the
treatment of tumors, and agents used in the treatment of tumors.

3\. Development of in vivo animal models systems that can be used to
study the immune response to tumors and the mechanisms of immunotherapy.

4\. Synthesis, structure and function of soluble factors that
participate in, activate and/or regulate hematopoietic cell growth and
the immune response to tumors, including interferons, other lymphokines
and cytokines (interleukins), hematopoietic growth factors, helper
factors, suppressor factors and cytotoxic factors.

5\. Application of biochemical, molecular biological and immunological
techniques for identifying tumor antigens that are good targets for the
development of vaccine-type strategies of cancer immunotherapy.

6\. Development of techniques to enhance the immune response to tumors,
including modification of tumor cells and/or antitumor lymphocytes to
facilitate cancer vaccine strategies.

7\. Development of improved methodology for manipulating bone marrow
inoculum to decrease the incidence of graft-versus-host disease without
increasing the risk of graft failure or leukemic relapse.

8\. Development of improved methodology for increasing the number of
peripheral blood stem cells available for harvest for use in
transplantation, including improved methods of identifying and removing
residual leukemic cells in the autologous transplant setting.

9\. Development of methods to identify and define human minor
histocompatability antigens.

10\. Development of novel culture systems to improve the expansion of
lymphocytes.

11\. Development of the combination of cell culture and other research
tools to better expand human hematopoietic stem cells.

12\. Development of improved techniques for computational
simulation/modeling of biological processes involved in immunologic
defenses against tumor cells such as signal transduction, cell cycle
progression, and intracellular translocation.

13\. Development of other novel technologies, methodologies or
instrumentation to facilitate basic research in either tumor immunology
or cancer hematology.

14\. Development of molecular, cellular or biochemical techniques to
isolate and/or characterize tumor stem cells from hematologic
malignancies.

D. ***[DNA and Chromosome Aberrations.]{.underline}*** The DNA and
Chromosome Aberrations Branch (DCAB) seeks to study the genome at the
DNA and chromosome level, including discovery of genes at sites of
chromosome breaks, deletions, and translocations; DNA repair; structure
and mechanisms of chromosome alterations; epigenetic changes; radiation-
and chemical-induced changes in DNA replication and other alterations;
and analytical technologies. Specific research and technologies
supported by DCAB in this solicitation include but are not limited to
the following:

1\. Development of new, improved technologies for characterization of
chromosomal aberrations in cancer.

2\. Development of new, improved, or high throughput technologies for
whole genome scanning for chromosome aberrations in cancer.

3\. New or improved technologies to increase accuracy of karyotypic
analyses of tumor specimens.

4\. New or improved methods to mutate or replace genes at specific sites
in intact cells.

5\. Development of new, sensitive methods to assess the methylation
status of genes.

6\. Development and distribution of genomic resources suitable for
genomic manipulation or cytogenetic studies.

7\. Technologies for assaying for mammalian genes relevant to repair of
damage induced by exposure of mammalian cells to ionizing and
non-ionizing radiations, with special emphasis on human cells.

8\. Methods/approaches to study the repair of DNA lesions induced by
exposure of mammalian cells to ionizing radiations (both high- and
low-LET).

9\. Development and characterization of human cell lines with specific
DNA-repair deficiencies.

10\. Development of genetic constructs that utilize radiation-responsive
regulatory genes to control the expression of targeted structural genes
in mammalian cells.

11\. Development of new methods/technologies to assay transcription
factor binding sites across whole genomes.

12\. Use of RNAi and siRNA in the development of novel methods and tools
for the study of gene expression, gene silencing, gene regulation, and
genome-wide screening in cells and tissues.

E. ***[Mouse Models of Human Cancers Consortium.]{.underline}*** The
Mouse Models of Human Cancer Consortium is a program based in the Office
of the Director, DCB. The Consortium has the important goal of providing
mouse cancer model-related resources and infrastructure to the research
community, in part through various outreach activities. The outreach
requirement generates the need for innovative educational or
informational materials that convey the content of Consortium meetings
and symposia, or document hands-on workshops in which models or
techniques that are pertinent to mouse modeling are demonstrated. The
instructional materials may be CD-ROMs, videotapes, Web-based
interactive programs, or other media.

F. ***[Structural Biology and Molecular Applications.]{.underline}***
The Structural Biology and Molecular Applications Branch (SBMAB) focuses
on structural and molecular studies to explore the processes of
carcinogenesis and tumorigenesis. Areas of interest include structural
biology, genomics, proteomics, molecular and cellular imaging,
enzymology, bio-related and combinatorial chemistry, and bioinformatics,
as they apply to cancer biology. Interests also include modeling and
theoretical approaches to cellular and molecular dimensions of cancer
biology. Specific research and technologies supported by SBMAB in this
solicitation include but are not limited to:

1\. Development of new technologies to facilitate the analysis and
determination of the molecular structure of biomolecules associated with
cancer.

2\. Development of new, improved, or high throughput technologies for
whole genome scanning for gene identification.

3\. Development of systems that will automate the technology of
culturing or assaying single cells.

4\. New or improved technologies for efficient microdissection of tumor
tissue sections and the development of tissue arrays.

5\. Improved extraction techniques for tumor specimens for subsequent
DNA, RNA, and protein analyses.

6\. Rapid methods to isolate intact complexes of regulatory proteins and
to separate and identify the proteins.

7\. New or improved technologies for the preservation of small amounts
of DNA/RNA/protein samples

8\. Development of new techniques and vectors for transfer of genes,
proteins, and antisense molecules into cells.

9\. Generation of software and computer models for the prediction of
macromolecular structure and function.

10\. Development of bioinformatic tools for the study of cancer biology
including facilitating genome data, gene "mining," cluster analysis, and
data base management.

11\. Development of novel gene technology (e.g., microarray,
differential display technology) for measurement of differential gene
expression levels and functional genomics studies.

12\. Development of novel proteomic tools for the analysis of protein
expression in cancer biology.

13\. Computer-based methodologies to assist in the understanding of
signal transduction and cancer biology.

14\. Methodologies and techniques for the imaging of macromolecules in
vitro and in vivo.

15\. Development of other novel technologies, methodologies or
instrumentation to facilitate basic research (research tools) in cancer
biology.

16\. Develop new approaches and technologies for the structural
determination of large biomolecular complexes.

17\. Development and integration of nanotechnology approaches and tools
in basic cancer biology research.

18\. Application and development of novel approaches for in vivo and in
vitro modifications of protein expression in cells and tissues, e.g.
RNAi.

19\. Mathematical and theoretical models for the understanding of cancer
biology.

20\. Development of new software and lab analysis tools that will
improve the recording and collection of data and experimental protocols
in order to facilitate cancer biology research.

G. ***[Tumor Biology and Metastasis.]{.underline}*** This branch
supports research that seeks to understand the interactions of cancer
cells with the tumor and/or host microenvironment in order to delineate
the molecular mechanisms and signaling pathways of tumor angiogenesis
and lymphangiogenesis, cell migration and invasion, tumor progression,
and metastasis. This includes examination of cell-cell and cell-matrix
interactions, and the roles played by cell growth factors and cytokines,
adhesion molecules, cytoskeleton and the nuclear matrix, and
matrix-degrading enzymes, as well as studies on the pathology and
biology of solid tumors and tumor bearing animals, and the development
of technology to facilitate these studies. Emerging areas of emphasis
are the microenvironment created by inflammation and the inflammatory
signaling molecules in tumor initiation and progression and the role of
somatic stem cells in determining tumor progression and metastatic
behavior. Stem cell motility, positional information cues from
surrounding tissue and adhesion properties together with issues of
epithelial-mesenchymal transitions related to cancer progression are
supported. Emphasis is also placed on the role of the extracellular
matrix and tissue microenvironment during development and tissue
morphogenesis, and on the role of glycoproteins in tumor growth,
invasion, and metastasis. The branch also focuses on the function of
steroid hormones, their receptors and coregulators during tumor growth
and progression. Models utilized in these studies may include animal
models, tumor tissues/cells, their components, or their products. The
development of organotypic models that closely mimic in vivo models is
encouraged. Specific research and technologies supported by TBMB in this
solicitation include but are not limited to:

1\. New technical strategies to identify and assess the function of
components of the extracellular matrix.

2\. Development of new in vitro cancer models to study the pathology and
biology of solid tumors and tumor bearing animals.

3\. New in vivo models of angiogenesis, lymphangiogenesis, cancer
progression and metastasis.

4\. Development of technologies to identify novel factors that modulate
angiogenesis and lymphangiogenesis.

5\. Identification of genes and/or enzymes associated with glycosylation
in tumor cells.

6\. Identification of novel coregulators of nuclear steroid receptor
superfamily.

7\. Development of improved techniques for computational
simulation/modeling of biological processes involved in malignant
transformation, persistence, or invasion, such as signal transduction,
cell cycle progression, and intracellular translocation.

8\. Development of new assays or methods to evaluate tumor cell
invasiveness.

9\. Development of new assays or methods to study molecules and pathways
involved in cell-to-cell signaling or communication.

10\. Development of appropriate new animal, cellular or organotypic
models to study tumor stroma interactions, 3-D models that closely mimic
*in-vivo* conditions.

11\. Study roles of cytokines/growth factors released by host cells
during inflammation, invasion, tumor progression and metastasis.

[]{#__RefHeading___Toc124236911 .anchor}Division of Cancer Control and
Population Sciences

The Division of Cancer Control and Population Sciences conducts basic
and applied research in the behavioral, social, and population sciences,
including epidemiology, biostatistics, and genetics that, independently
or in combination with biomedical approaches, reduces cancer risk,
incidence, morbidity, and mortality. Laboratory, clinical and
population-based research, and health care are translated into cancer
prevention, detection, treatment, and rehabilitation activities that
cross the life span and the entire process of carcinogenesis, from
primary behavioral prevention in youth, to screening, treatment, and
survivorship. For additional information, please visit our home page at
[http://dccps.nci.nih.gov](http://dccps.nci.nih.gov/).

A. ***[Epidemiology and Genetics.]{.underline}*** The Epidemiology and
Genetics Research Program supports research in epidemiology, biometry,
genetic epidemiology, molecular epidemiology, nutritional epidemiology,
infectious epidemiology, environmental epidemiology, computing
methodology, and multidisciplinary activities related to human cancers.

The updated topics of interest to the Epidemiology and Genetics Research
Program (EGRP) are:

-   **Tools for assessment of exposures and biomarkers:**

```{=html}
<!-- -->
```
-   Development of methods for measuring biomarkers of human exposure or
    susceptibility, and of nutritional status, and methods for
    monitoring changes in biomarkers for use in cancer epidemiologic
    studies.

-   Development of new or improved devices for quantitative measurement
    of human exposure to environmental carcinogens for epidemiologic
    studies.

-   Development of methods to evaluate potential cancer clusters for
    epidemiologic studies.

```{=html}
<!-- -->
```
-   **Tools for cancer epidemiology studies:**

```{=html}
<!-- -->
```
-   Development of tools to model cancer risks from environmental and
    occupational agents.

-   Development of software for electronic capture of risk factor data
    for cancer epidemiologic studies.

-   Build consumer-friendly risk prediction models from epidemiologic
    data.

-   Development of software for tracking biological specimens for cancer
    epidemiologic studies.

-   Development of software for electronic identification, screening,
    and recruitment of participants, especially minorities, into
    epidemiologic studies.

-   Development of Web-based data collection or applicable
    bioinformatics tools for cancer epidemiology.

-   Development of software or methods for rapid case ascertainment of
    cancers.

-   Development of geographic information systems with special
    visualization techniques for the simultaneous assessment of
    environmental exposures and health outcomes.

-   Development of tools using publicly available data to identify
    population-based controls for epidemiologic studies.

-   Development of software for analysis of DNA methylation biomarkers
    for early detection of prostate or breast cancers with use of
    specimens from biorepositories.

For more information on this program please go to
[http://epi.grants.cancer.gov](http://epi.grants.cancer.gov/).

B. ***[Multimedia Technology and Health Communication in Cancer
Control.]{.underline}*** The NCI promotes communication about and
dissemination of information about cancer. Toward these efforts, the
Behavioral Research Program (BRP) uses its SBIR/STTR Multimedia
Technology Health Communication Program to fund translational research
using a variety of multimedia.

The objectives of this program are to (1) *fund* science-based,
theory-driven, user-centered grants and contracts to translate cancer
research into programs, interventions, systems, networks, or products
needed by professionals or the public to reduce cancer risk or improve
the quality of life of cancer survivors; (2) *promote the use of*
innovative media technology and/or communication approaches in cancer
prevention and control applications used in medical and community
settings; (3) *improve* communication behaviors of primary care
professions, patients, and care-givers in cancer-related matters; (4)
*promote* organizational infrastructures changes that promote the use of
products developed in the program; (5) *promote* the development of
system models; and (6) *expand* the methods for evaluating ehealth
research and developed products.

Investigators interested in applying for grants in this SBIR program
should access: <http://cancercontrol.cancer.gov/hcirb/sbir/> for a list
of topics that address current gaps in ehealth research. This list
replaces previously listed research categories. This site also provides
important program requirements and SBIR information.

For questions, contact the Program Director at <cd34b@nih.gov>.

[]{#__RefHeading___Toc124236912 .anchor}Division of Cancer Treatment and
Diagnosis

The Division of Cancer Treatment and Diagnosis funds research into the
development of tools, methodologies and therapeutic agents that will
better diagnose, assess, cure and effectively treat cancer. We support a
spectrum of research projects from preclinical exploratory research and
development through clinical trials.

A. ***[Cancer Diagnosis.]{.underline}*** The Cancer Diagnosis Program
(CDP) supports the development of technologies, reagents,
instrumentation, and methodologies to improve cancer diagnosis or
prognosis or to predict or assess response to therapy. This does not
include technologies for imaging of patients. CDP also supports the
adaptation or improvement of basic research technologies for use as
clinical tools. Technologies supported by CDP may be designed to work
with tissues, blood, serum, urine, or other biological fluids.
Technologies supported by CDP include but are not limited to the
following:

1\. Technologies for comprehensive and/or high throughput analysis of
molecular alterations at the level of DNA, RNA, or protein. Includes for
example, mutation detection systems, gene expression arrays, systems for
monitoring epigenetic changes (alternative splicing or methylation),
high throughput proteomics (including post-translational modification
and protein-protein interactions and methods for protein quantitation).

2\. Micro-electro mechanical systems (MEMs) and other nanotechnologies
for the analysis of DNA, RNA, or protein (e.g., micro-capillary systems,
lab on a chip applications, micro-separation technologies).

3\. Mass spectrometry for the analysis of nucleic acids or proteins.

4\. Discovery and development of new or improved diagnostic markers or
probes targeting changes in DNA, RNA, or proteins, including the
generation of molecular diversity libraries by phage display and other
combinatorial techniques, and affinity-based screening methods.

5\. cDNA library technologies, including improved methods for generating
high quality cDNA clones and libraries and methods for generating high
quality cDNA from tissues (including archived specimens).

6\. Resources for clinical research.

a\. Instruments, technologies or reagents for improved collection,
preparation, and storage of human tissue specimens and biological
fluids.

b\. Improved methods for isolation and storage of DNA, RNA, or proteins.

c\. Tissue and reagent standards: development of standard reagents such
as representational DNA, RNA, and proteins and standard tissue
preparations to improve the quality of or facilitate the validation of
clinical laboratory assays.

d\. Methodologies for directed micro-sampling of human tissue specimens,
including for example, new or improved methodologies for tissue
microarrays.

7\. Tissue preservation: fixatives and embedding materials or
stabilizers that preserves tissue integrity and cellular architecture
and simultaneously allows molecular analysis of DNA, RNA, or proteins.

8\. Bioinformatics.

a\. Methods for acquisition and analysis of data associated with
molecular profiling and other comprehensive molecular analysis
technologies, including for example, analysis of microarray images and
data as well as methods to combine, store and analyze molecular data
produced by different techniques (e.g., combined analysis of proteomics
and gene expression data).

b\. Methods for collecting, categorizing or analyzing large data sets
containing pathology data or histological images and associated clinical
or experimental data, including for example, tumor marker measurements,
tissue microarray data, and other relevant biological information.

c\. Software/algorithms to interpret and analyze clinical and pathology
data including methods that relate data from clinical databases to
external data sources. Includes for example, neural networks, artificial
intelligence, data-mining, data-trend analysis, patient record
encryption protocols, and automatic diagnostic coding using standard
nomeclatures.

d\. Informatics tools to support tissue procurement and tissue banking
activities.

9\. Statistical methods and packages designed for data analysis
including correlation of clinical and experimental data.

10\. Automated Cytology.

a\. High resolution image analysis for use with specimens (e.g., blood,
tissues, cells) and tissue microarrays.

b\. Instrumentation including microscopy and flow cytometry.

c\. CGH, FISH, immunohistochemical staining and other hybridization
assays using probes with fluorescent or other novel tags.

d\. Methods for single cell isolation and sorting.

e\. Methods for single cell classification and analysis.

11\. Instrumentation for the detection and diagnosis of tumors,
including endoscopy and magnetic resonance spectroscopy (MRS).

12\. Immunoassays using monoclonal, polyclonal, or modified antibodies.
Affinity-based binding assays using libraries of aptamers including
chemical ligands, small peptides or modified antibodies.

For additional information about areas of interest to the CDP Technology
Development Branch, visit our home page at:
[http://cancerdiagnosis.nci.nih.gov](http://cancerdiagnosis.nci.nih.gov/).

B. ***[Biochemistry and Pharmacology.]{.underline}*** Preclinical and
Exploratory Investigational New Drug (IND) studies designed to improve
cancer treatment. General areas of interest: Discovery of new drugs or
drug combinations and treatment strategies, selective targeting,
development of clinically relevant preclinical models, pharmaceutical
development, ADME (absorption, distribution, metabolism and excretion)
studies and toxicologic evaluations, understanding mechanisms of drug
actions (responses to therapies), and preventing and overcoming drug
resistance. Areas of current emphasis: Molecular targeted approaches,
including application of safety and efficacy biomarkers to the discovery
and development of drugs; application of advanced technologies, such as
nanotechnology and imaging technologies, to improved assays for
quantitation of safety and efficacy biomarkers; approaches that reduce
costs and increase speed of preclinical drug development; and approaches
that will lead to "personalized medicine," including better predictions
of drug response and adverse reactions, drug-drug interactions, and drug
efficacy monitoring. For additional information, please visit our home
page at [http://dtp.nci.nih.gov](http://dtp.nci.nih.gov/) and select
"Grants/Contracts."

1\. *[Drug Discovery]{.underline}*.

a\. Design and synthesize novel compounds for evaluation as potential
anticancer agents. Synthesize simpler analogs of complex antitumor
structures that retain antitumor activity.

b\. Develop computer modeling and biophysical techniques such as x-ray
crystallography and NMR spectroscopy.

c\. Design prodrugs of anticancer agents that are selectively activated
in cancer cells.

d\. Discover new anticancer agents that exploit unique properties of
tumors, that induce or modulate apoptosis, or that induce or modulate
differentiation.

e\. Design and synthesize anticancer prodrugs, latent drugs, or
modifiers of cancer drug metabolism or excretion.

f\. Develop ways to produce adequate quantities of promising natural
products or natural product derivatives through total synthesis.

g\. Develop scale-up and manufacturing technology for the synthesis of
materials with promising anticancer potential.

h\. Develop chemical libraries for anticancer drug screening programs.
The generation of small molecular weight libraries (\<700 MW, e.g.,
non-polymeric organic molecules, transition-state analogs, cyclic
peptides, peptidomimetics) is encouraged.

i\. Develop and apply technologies in genetics, genomics, proteomics,
glycomics, lipidomics, metabolomics, and systems biology to the
discovery of potential drug targets associated with multiple pathways or
networks. Design and optimize agents that block or activate targets that
are likely to control, retard or kill cancer cells.

2\. *[Drug Evaluation]{.underline}*.

a\. Develop and evaluate anti-metastatic and/or anti-angiogenesis agents
or strategies, including combination therapies, in appropriate model
systems.

b\. Develop and evaluate anticancer gene therapy in appropriate model
systems. The development of new gene delivery approaches is encouraged.

c\. Develop novel or improved in vitro and in vivo test systems. There
is a special need for new types of in vivo tumor models, such as
orthotopic tumor models, models using transgenic or gene knockout
animals, and models to evaluate agents that induce differentiation or
apoptosis.

d\. Develop strategies to detect, prevent, or overcome drug resistance.

e\. Develop novel treatment strategies such as extra corporeal
treatment.

f\. Develop new assays based on molecular targets, especially those that
may be amplified or altered in cancer cells. For example, develop assays
for agents that interact with oncogenes, suppressor genes, signal
transduction pathways, transcription factors, promoters. Assays based on
molecular targets that can be adapted for high volume screening of
chemical libraries are especially encouraged as well as in vivo models,
which can be used for "proof of concept" (i.e., validating selectivity
of the agent for the target and confirming that modulation of the target
results in antitumor activity).

g\. Develop cost-effective and useful techniques to improve in vitro
cell culture methodology, such as the development of automated systems,
serum-free media, or carbon dioxide-free buffering systems to stabilize
cell culture performance.

h\. Identify and employ novel targets for antitumor drug discovery
utilizing non-mammalian genetically defined organisms, such as fruit
flies, worms, zebrafish and yeast.

i\. Develop and apply technologies such as microarrays, proteomics or
RNAi to improve the efficiency of drug discovery.

j\. Develop cell lines that contain bioluminescent reporter genes, such
as luciferase, that can be controlled by activating specific promoters.

3\. *[Pharmaceutical Development]{.underline}*.

a\. Develop new methods to improve drug solubility for administration of
promising antitumor compounds, such as water miscible nontoxic water
solubility enhancing agents.

b\. Develop bioavailable alternatives to the intravenous delivery of
cytotoxic chemotherapy. For example, develop new excipients to enhance
oral bioavailability of anticancer agents.

c\. Develop biocompatible additives and excipients for highly
concentrated proteins and peptide formulations to enhance
bioavailability and stability suitable for subcutaneous delivery of
agents.

d\. Develop improved methods to reduce thrombophlebitis and other
related side effects observed following intravenous injection of some
anticancer drugs.

e\. Develop new and innovative techniques for sterilization of
parenteral dosage forms.

f\. Develop in vitro and in vivo models to predict human oral
bioavailability of anticancer drugs.

g\. Develop practical delivery systems involving nanotechnology
(dendrimers, nanoparticles, nanoshells, etc.) or other strategies to
deliver anticancer drugs to specific target sites.

h\. Develop new technology to manufacture liposomal and intravenous
emulsions in an environmentally friendly manner and in accordance with
OSHA standards.

i\. Develop additives and/or processes to eliminate cold chain storage
of biotherapeutic agents, especially vaccines.

4\. *[Toxicology and Pharmacology]{.underline}*.

a\. Develop biochemical or molecular (genomic, proteomic, or
metabolomic) response profiles of specific target organs (e.g., bone
marrow, gastrointestinal tract, liver, kidney, heart, lung) to permit
rapid identification of toxic effects resulting from anticancer drug
administration.

b\. Develop clinically relevant in vitro and/or in vivo tests for
estimation and prediction of gastrointestinal toxicity, neurotoxicity
(central and peripheral), cardiotoxicity, hepatotoxicity, nephrotoxicity
and pulmonary toxicity.

c\. Correlate in vivo and in vitro models for organ toxicity as
described above in 4b. Validate for various anticancer drugs.

d\. Develop drug metabolism (Phase I and Phase II) profiles for
anticancer agents in human, mouse, rat and dog liver S-9, microsomes and
slices.

e\. Develop systems to identify toxic effects of drugs by characterizing
reactions with biomolecules or receptors.

f\. Develop in vitro tests to detect, qualify and quantify toxic effects
of antineoplastic drugs. Develop techniques for determining individual
variations in drug responses due to genetic polymorphisms or other
factors.

g\. Develop personal computer programs for pharmacokinetics models
capable of predicting drug behavior in humans from preclinical
pharmacokinetics data in mice, rats, dogs, and non-human primates.

h\. Investigate and develop techniques for relating specific enzyme
activities (both catabolic and anabolic) to body sizes of different
species.

i\. Investigate techniques that would allow parameters, e.g., Km and
Vmax for enzymes, to be scaled from preclinical to clinical models.

j\. Develop analytical strategies applicable to the quantitation of
potent anticancer drugs in biological fluids at the pg/ml level, e.g.,
Bryostatin.

k\. Develop non-invasive techniques to determine drug distribution in
various animal models.

l\. Evaluate interspecies transporter distribution and its impact on
pharmacokinetic parameters, e.g., the impact of pharmacogenetic
variation in biodistribution.

m\. Determine optimal pharmacokinetic sampling schedules for use in dose
titration/pharmacodynamic assessment by integrating information such as
pre-clinical pharmacokinetic data, physico-chemical drug properties and
mechanism of action.

n\. Develop an in vitro/in situ system for high throughput drug screens
for oral bioavailability.

o\. Develop and deliver organ specific chemo-protective agents.

p\. Develop and evaluate rapid, cost-effective methods, including
biochemical, functional multiplexed, imaging, nanotechnology-based, and
microfluidics-based assays, to quantitate surrogate endpoints for
determination of doses, dosing schedules, safety, and efficacy of drugs.

q\. Identify and develop biomarkers to evaluate drug activities and
toxicities.

r\. Develop assays in support of Exploratory Investigational New Drug
Studies using biomarkers or other appropriate endpoints.

s\. Develop, standardize, and validate cost-effective tools for
obtaining comprehensive ADME and toxicology profiles that may better
predict the performance of drugs in humans.

t\. Develop and analytically validate assays or tools for measuring
safety, efficacy, and dosing biomarkers.

5\. *[Animal Production and Genetics]{.underline}*.

a\. Investigate alternatives to expensive barrier systems for exclusion
of pathogens from rodent colonies, e.g., by use of micro-isolator cages,
and evaluate their performance.

b\. Develop and evaluate specialized shipping containers for
pathogen-free animals.

6\. *[Natural Product Discoveries]{.underline}*. Note that execution of
projects in most of these topic areas will require collaboration and
signed agreements with countries where the source organism was
originally collected.

a\. Develop techniques for the study of non-culturable organisms in
order to identify antitumor agents.

b\. Develop techniques for the genetic and biochemical characterization
and the manipulation of biosynthetic pathways to create leads. Use
combinatorial biosynthesis to generate libraries of un-natural natural
products as drug leads.

c\. Use genetic techniques for the identification of microbial
consortia, and for the identification and isolation of genes controlling
the biosynthetic pathways producing potential antitumor agents.

d\. Express biosynthetic pathways from microbes or microbial consortia
that are known to produce antitumor agents, but in organisms amenable to
standard fermentation techniques.

e\. Investigate new biological methods, such as tissue culture,
aquaculture, hydroponics, etc., for the production of natural products
as potential anticancer agents.

f\. Develop new systems of large-scale production using
biotransformation, tissue or cell culture, biotechnology, modification
of the chemical ecology of producing organisms, etc., in order to
produce the large quantities of anticancer drugs needed for preclinical
or clinical development.

g\. Develop methods for the isolation, purification, identification,
cultivation, and extraction of microorganisms from unusual marine or
terrestrial habitats for antitumor screening. Examples are gliding
bacteria, barophilic, endophytic, thermophilic, and tropical canopy
organisms.

h\. Investigate newer methods of isolation and purification, such as
super-critical fluid extraction and chromatography, centrifugal
countercurrent chromatography or affinity-based separations, in the
isolation and purification of natural products with anticancer activity.

i\. Develop simple immunoassays that can be used to monitor the levels
of natural products of interest in simple extracts of the relevant raw
material. These assays should be capable of being developed for use "in
the field" and also in developing countries.

j\. Develop analytical and biological methods for isolation,
purification and validation of active constituents identified from
alternative medicine and complementary studies; use of these purified
constituents alone or in combination with conventional anticancer
agents.

7\. *[Data Management Systems]{.underline}*.

a\. Develop data support systems for chemical library programs.

b\. Develop bioinformatics tools to accelerate the identification,
functional understanding and validation of drug targets.

c\. Develop bioinformatics tools to predict ADME and toxicology
characteristics of drug candidates.

d\. Develop "data mining" strategies such as neural networks.

e\. Develop algorithms for determining optimal drug combinations and for
prediction of optimal effectiveness of individual agents.

f\. Develop bioinformatics tools to support a systems biology approach
to drug discovery and development.

g\. Develop bioinformatics tools to support genomic/proteomic and other
\"omics\" profiling experiments in support of drug discovery and
development.

C. ***[Cancer and Nutrition.]{.underline}*** Research to improve the
methodology of nutritional assessment in a cancer population. Innovative
approaches to evaluate the contribution of nutritional status to
response to cancer treatment.

1\. Research to improve the methodology of nutritional assessment in a
cancer population.

2\. Develop means to evaluate the contribution of nutritional status to
response to cancer treatment.

D. ***[Clinical Treatment Research.]{.underline}*** Clinical research
studies designed to improve cancer treatment. Emphasis is on clinical
trials for the evaluation of new therapeutic agents, development of
assay systems to measure patient response to chemotherapy, development
of prognostic assays, and development of methods of analysis and
management of clinical trials data. Studies designed to improve human
subject protections for patient access to clinical cancer trials.

1\. *[Evaluation of New Cancer Therapies]{.underline}*.

a\. Conduct clinical trials for the evaluation of new therapeutic agents
or modalities of treatment employing drugs, biologics or surgery.

b\. Clinical trials using "unconventional therapies," including, but not
limited to, behavioral and psychological approaches, dietary, herbal,
pharmacologic and biologic treatments, and immuno-augmentative
therapies.

c\. Development and evaluation of new clinical approaches using gene
transfer or gene therapy technologies.

d\. Development and evaluation of new clinical approaches using tumor
associated antigens or vaccines in order to enhance immunogenicity.

e\. Develop and characterize novel chemical compounds that may be useful
anticancer agents, either alone or in combination with other modalities
such as radiotherapy.

f\. Develop techniques to lessen the toxicity of existing anticancer
treatments.

g\. Develop new techniques for the delivery of anticancer agents that
will maximize therapeutic effects and minimize toxicity.

h\. Develop new surgical techniques or tools or improve existing
techniques that are/may be utilized in cancer treatment.

i\. Characterize and produce clinical grade monoclonal antibodies to
detect and treat malignancies.

2\. *[Development of Prognostic Assays to Monitor Patient Response to
Therapies]{.underline}*.

a\. Develop assay systems to measure the response of human tumors to
chemotherapy or biologics.

b\. Characterize drug resistance mechanisms and design methods to
overcome clinical drug resistance.

c\. Develop assays for prognostic factors to identify patient subsets
who may benefit from specific cancer treatment therapies.

d\. Development of assays to assess effects of agents on specific
molecular targets in clinical studies.

e\. Develop new techniques for relating past preclinical information to
past clinical results for prediction of future useful clinical agents
from future preclinical data (both in vitro and in vivo).

3\. *[Clinical Trials Informatics]{.underline}*.

a\. Develop new tools and methodologies for the analysis of clinical
trials results.

b\. Develop new informatics tools to facilitate clinical trials data
entry from the bedside and coordination of data entry and transmission
throughout the institution and to other collaborating institutions or
organizations.

c\. Development of novel web-based approaches to clinical trials
informatics for transmission of data to NCI or other organizations.
Topics include point of treatment data capture and reporting, electronic
protocols, OLAP (On-line Analytical Processing), support for the Common
Toxicity Criteria, and drug accountability support.

d\. Develop new interchange standards, based on technologies such as
XML, for sharing data among heterogeneous systems. Specific applications
areas include, Adverse Even Reporting, Case Report Forms.

e\. Develop new tools for support of Common Data Elements.

f\. Develop new approaches for interface with electronic medical
records, with intent to streamline data reporting, registration, and
toxicity reporting of Clinical Trial information.

E. ***[Cancer Imaging Program.]{.underline}*** The mission of this
program is to promote and support: Cancer-related basic, translational
and clinical research in imaging sciences and technology, and
integration and application of these imaging discoveries and
developments to the understanding of cancer biology and to the clinical
management of cancer and cancer risk.

Toward this effort, CIP 1) funds research in the development of tools,
methodologies and imaging agents/probes that will better diagnose,
assess, and effectively treat cancer, and 2) supports a spectrum of
research projects from preclinical exploratory research and development
through clinical trials. Specifically:

1\. Development of medical imaging systems for early cancer detection,
screening, response to therapy and interventions including image-guided
therapy.

2\. Development of preclinical and clinical in vivo imaging systems,
methods, imaging probes and contrast agents and related image
reconstruction, image processing, image display and image-based
information as required to detect, classify, monitor and guide
therapeutics to cancer and precancerous conditions.

3\. Development of methods to assess the value of imaging procedures for
the above goals.

4\. Development of systems and methods for improved production and
distribution of radioactive materials for cancer imaging and/or
treatment.

5\. Development of systems, methods and their optimization for studying
the adverse reactions/effects of image-guided and other diagnostic and
therapeutic interventions.

6\. Any other investigator-initiated research idea that is relevant to
cancer biomedical imaging.

7\. Development of systems, methods and their optimization to advance
the role of imaging in assessment of response to therapy through
increased application of quantitative anatomic, functional, and
molecular imaging endpoints in clinical therapeutic trials and
dissemination of these systems and methods with appropriate scientific
communities.

F. ***[Radiation Research.]{.underline}*** The Radiation Research
Program (RRP) supports basic, developmental and applied research
(including clinical) related to cancer treatment utilizing ionizing and
non-ionizing radiations. Therapeutic modalities include photon therapy,
particle therapy, photodynamic therapy (PDT), hyperthermia,
radioimmunotherapy (RIT), systemic targeted radionuclide therapy
(STaRT), and boron neutron capture therapy (BNCT). Radiation research
encompasses a range of scientific disciplines including basic biology,
chemistry, physics and clinical radiation oncology. Topics of interest
include, but are not limited to, the following areas:

1\. Development of devices for planning, measuring, and delivering
radiation therapy or related therapies, including devices for patient
positioning and quality assurance for the following: (a) ionizing
radiation, particularly 3-dimensional conformal radiotherapy (3DCRT) and
intensity-modulated radiotherapy (IMRT); (b) PDT; (c) hyperthermia; (d)
RIT; (e) STaRT; and (f) particle therapy.

2\. Development of devices for dosimetry for (a) ionizing radiation; (b)
PDT, particularly those capable of measuring light doses at depth in
tissues; (c) thermometry for hyperthermia, particularly non-invasive
thermometry; and (d) RIT.

Devices may include chemical, solid state, film, biological or
ionization systems to detect or read out exposures. Accuracy, precision
and linear response are essential over the range of doses and
temperatures employed in the research laboratory and/or in the clinic,
depending on their intended use. Devices for thermometry during
hyperthermia treatment must give accurate readings with the heating
device(s) with which they are to be used.

3\. Development and evaluation of computer hardware and software for
radiation therapy, such as computation algorithms, computer
workstations, image guidance techniques, and informatics methods for
treatment planning, delivery and outcomes analysis.

4\. Development of novel drugs to increase the effectiveness of
radiation therapy or related therapies: (a) chemical modifiers of
radiation response, particularly small molecules directed at molecular
targets involved in tumor radioresistance; (b) photosensitizers for PDT;
(c) sensitizers for use with hyperthermia; and (d) prodrugs that are
selectively activated within the tumor.

5\. Development of drugs to prevent, reduce or reverse normal tissue
response, especially the late effects that develop months or years after
therapy.

Compounds that are based on a rationale for achieving a therapeutic gain
(an improved differential response between tumor and normal tissue) are
of greatest interest. Enhancement of response must be achieved at
radiation doses and treatment schedules employed clinically.

6\. Development of predictive assays and monitors of response to
radiotherapy, PDT, hyperthermia, STaRT, or RIT. Tools are needed to
identify patients that would benefit from specific therapeutic
approaches.

G. ***[Biological Response Modifiers (BRM).]{.underline}*** Research on
agents or approaches that alter the relationship between tumor and host
by modifying the host\'s biological response to tumor cells with
resultant therapeutic benefits. Both preclinical and clinical
investigations are conducted on the utility of a wide variety of natural
and synthetic agents and on biological manipulations of immunological
and non-immunological host mediated, tumor-growth controlling mechanisms
in cancer therapy.

Studies are encouraged which utilize in vitro assays and/or animal model
systems to investigate mechanisms of BRMs. Examples of innovative
research that would be responsive to this solicitation include:

1\. Evaluation of molecular genetic approaches to discovery of new
therapeutic agents, delivery of BRMs or development of gene therapy.

2\. Development of improved techniques to synthesize, screen and develop
new oligonucleotides including iRNA sequences for therapeutic purposes,
such as signal modulation, anti-ongogene or anti-viral effects.

3\. Improvement in cell-culturing techniques, e.g., by developing
automated cell culture systems, specialized media, or improved methods
to induce activation, proliferation or differentiation.

4\. Development of new procedures or reagents for the modulation of the
suppressor arm of the immune system in experimental models, directed
towards successful immunotherapy.

5\. Improvement of tumor-associated antigens or vaccines in an attempt
to enhance immunogenicity.

6\. Evaluating autoimmunity in the context of anti-tumor response *in
vivo* to vaccines.

7\. Development of novel in vitro assays for the primary screening of
BRMs.

8\. Application of observations describing shared receptors and
mediators between the neuroendocrine and immune systems in studying
immunobiology and immunotherapy of cancer.

9\. Development and optimization of viral oncolytic agents.

10\. Development of novel or improved methods for process development
and manufacture of biotherapeutics, including but not limited to
antibodies, recombinant proteins, peptides, oligonucleotides, and
products based on viral or bacterial vectors, per executive order (E.O.
13329) mandating federal agencies assist the private sector in
manufacturing innovation efforts.

11\. Development of innovative methods for monitoring the manufacturing
process for biotherapeutics using in-line or on-line process analyzers
to improve the efficiency of process controls and determination of
production end-points (see Guidance for Industry, PAT-A Framework for
Innovative Pharmaceutical Manufacturing and Quality Assurance,
[www.FDA.gov](http://www.fda.gov/)).

12\. Development of methods to more efficiently assess factors related
to the ultimate product quality, safety and efficacy of biologics.

[]{#__RefHeading___Toc124236913 .anchor}Division of Cancer Prevention

The Division of Cancer Prevention (DCP) directs an extramural program of
cancer prevention research including chemoprevention, nutritional
science, genetic, epigenetic, and infectious agent, early detection
including biomarker development and validation and biometry for the
Institute. DCP also supports research training and career development in
cancer prevention and early detection and coordinates community-based
clinical research in cancer prevention and dissemination of cancer
treatment practice through a consortium of community clinical centers.
For additional information, please visit our home page at
<http://dcp.nci.nih.gov/>.

A. ***[Prevention.]{.underline}*** Research studies to identify,
evaluate, and implement techniques and approaches for the prevention,
risk assessment, and early detection of cancer. Those studies capable of
achieving these objectives with minimal risk and cost are preferred.

1\. *[Chemoprevention]{.underline}*. Studies in which naturally
occurring or synthetic agents are identified, or further evaluated for
efficacy or safety. Studies involving in vitro assays with cell
transformation systems, in vivo assays involving animals models to
evaluate agents against typical carcinogenic agents at specific sites,
and studies involving clinical chemistry measurement of agents in sera
or other biological fluids are of highest program relevance. Studies
aimed at improving future research designs for chemopreventive trials;
providing additional biological understanding, identification and
evaluation of modulation of quantitative or qualitative biological
endpoints, and/or markers for surveillance of compliance will also be
considered. Examples of tests might include measurements of biochemical
parameters, cytological screening techniques, in vitro studies of
suppression of oncogene protein products, enhancement of tumor
suppressor genes, in vitro toxicological studies, and synthesis of novel
chemopreventive agents based on structure/activity relationships.

2\. *[Diet and Nutrition]{.underline}*. The Nutritional Science Research
Group supports studies that aim to reduce the incidence of cancer
through dietary modification, which may include additions, deletions, or
substitutions of foods or dietary factors.

Topics of interest include:

a\) In vivo animal models, including transgenics and knockouts, to
examine the cancer prevention effects of essential and non-essential
nutrients.

b\) Invertebrate models for the study of bioactive food component-gene
interactions involved with cancer prevention.

c\) Novel technologies for measuring the effects of diet on differential
gene expression, epigenetic events, proteomics, and associated
metabolomic changes.

d\) New models/approaches for examining diet-immunity interactions.

e\) Educational interactive software packages that focus on dietary
exposures and cancer prevention.

f\) New and improved diagnostic markers for nutritional status.

g\) New methods to detect and identify anticarcinogenic nutrients in
foods.

h\) New methods for the isolation and preparation or synthesis of
candidate nutrients in quantities suitable for preclinical and clinical
screening.

i\) Valid, more facile and effective methods for assessing the content
of bioactive food components in foods and dietary supplements.

j\) Transgenic/knockout food models for testing the physiological
significance of bioactive food components within the food matrix.

k\) Combinations or blends of bioactive food components for cancer
prevention, including the importance of the food matrix.

l\) Bioinformatics tools for the study of bioactive food components as
regulators and modulators of genes associated with cancer prevention.

m\) New bioengineering tools for the study of bioenergetics and obesity.

B. ***[Community Oncology.]{.underline}*** Introduction, application,
and evaluation of effective and practical cancer control intervention
programs in community settings. Primary emphasis is on the integration
and involvement of community physicians and allied health professionals
in cancer control efforts and the promotion of linkages between
community practitioners/hospitals and other regional resources for
cancer control.

Objectives are to: (1) reduce the time between research advances in
prevention, detection, and patient management and their application in
community settings; and (2) expand extend the cancer care knowledge and
applications bases; and (3) evaluate new detection and diagnostic
methods for specificity, sensitivity, reliability, validity, safety,
feasibility and cost when applied to defined or target populations. This
may include screening research as well.

C. ***[Rehabilitation and Continuing Care.]{.underline}*** Development
and evaluation of rehabilitation or continuing care strategies which
directly enhance functioning of patients with cancer or which contribute
to understanding of factors impacting utilization of supportive services
by cancer patients. Clinical applications include development and
testing of interventions to enhance multidisciplinary approaches to
cancer rehabilitation, and research on effective symptom management
(e.g., cancer-related pain, fatigue, nausea, mucositis). Areas of
general program interest include innovative approaches to measuring and
enhancing quality of life of cancer patients; research to investigate
and enhance clinical decision-making by both patients and physicians;
and studies of the impact of individual preferences for health care
outcomes and their impact on cancer prevention practices in persons
without cancer and on treatment decisions in patients with cancer.

D. ***[Early Detection and Screening.]{.underline}*** New diagnostic or
screening methods for early detection of cancer, especially for
asymptomatic patients. Detection methods can include any cancer site,
although there is more interest in the common cancers, such as those of
the lung and colon. Methods should be cost beneficial and applicable in
a clinical setting.

1\. Studies which identify and document new databases relevant to early
cancer detection and propose using new and experimental analytical
techniques.

2\. Analyses of long-term, follow-up data from completed studies for
potential new interpretations based on the passage of time.

3\. Studies which propose to develop and evaluate new detection
techniques and measures for sensitivity specificity, reliability,
validity and safety.

4\. Determinations of the cost/benefit or risk/benefit ratios of cancer
screening and detection methods when applied in defined or target
populations.

5\. Currently, the most commonly used method to detect prostatic cancer
is the digital rectal examination. Various devices and models would be
necessary for the early detection of prostate cancers by physical
examination. They would include, but not limited to the following
disease states: (1) absence of disease (normal model); (2) benign
prostatic hypertrophy; (3) prostatitis; (4) Stage B1 prostatic cancer
(T2a); (5) Stage B2 prostatic cancer (T2b); and (6) Stage C prostatic
cancer (T3z, T3b, and T4).

6\. Development of products that aid the systematic collection and
transport of specimens used for the early detection of cancer, including
devices for the collection and transport of urine, serum, fecal
material, exfoliated cells, and other potential materials.

7\. Develop computer utility programs that can increase the clinical
uses of existing programs commonly found in medical offices creating
age-sex registries, predicting population risks, determining screening
needs of patients, reminder systems, etc. Develop bioinformatics to
study gene profiling.

8\. Develop personal computer programs that can be used to determine
population risks and the effect of interventions. These programs might
also be adopted to the concept of Community Oriented Primary Care.

9\. Use of ultrasonography with color flow imaging for the early
detection of cancer. Research on the use of ultrasonography with color
flow imaging (US-CFI) for the early detection of cancer of the ovary,
breast and/or prostate. Emphasis should be given to the ability of the
US-CFI to differentiate between malignant and benign disease at these
sites. Criteria for the discrimination of malignant from benign disease
would be developed as well as performance characteristics of this
method, particularly for breast and prostate. Studies on symptomatic
populations should yield sensitivity, specificity and positive
predicative values when breast and prostate are the target sites.
Studies on asymptomatic populations should yield sensitivity,
specificity and positive predicative values when ovarian cancer is the
target site.

10\. As more women seek mammographic breast screening, the importance of
efficient, high speed, "intelligent" mammographic systems capable of
acquiring and storing large volumes of images and enhancing image
interpretation will become more important. Technological developments of
interest are:

a\. Develop digital mammographic systems for high volume applications
with electronic archiving and image analysis capabilities.

b\. Develop artificial intelligence based interactive image analysis
software to enhance mammographic sensitivity and specificity.

E. ***[Cancer Biomarkers.]{.underline}*** The Cancer Biomarkers Research
Group (CBRG) promotes research on the discovery, development, and
validation of biomarkers for pre-cancer and early cancer detection and
relevant technologies so that risk can be more accurately assessed and
cancers can be detected at early stages of development. Early detection
has the potential to reduce cancer morbidity and mortality. In cancer
research, biomarkers refer to substances that are indicative of the
presence of cancer in the body. Biomarkers include genes, RNAs,
proteins, and metabolites. As the molecular changes that occur during
tumor development can take place over a number of years, biomarkers can
be potentially used to detect cancers early. Topics of interest include,
but are not limited to, the following areas:

1\. Discovery, development and/or validation of biomarkers (genomic,
epigenomic, proteomic and metabolomic) for precancerous lesions, early
cancer detection, and identification of risk.

2\. Development of new biological, genetic, histochemical, immunologic,
and molecular assay or analyses applied to early cancer detection, risk
assessment, or susceptibility.

3\. Development of new tools and technologies, including microfluidics
and nanotechnologies, for analyzing biomarkers for early cancer
detection and risk assessment.

4\. In silico data analysis for the discovery and identification of
cancer biomarkers.

5\. Ancillary studies to discover biomarkers from ongoing prevention and
treatment trials and any large studies.

6\. Development of statistical and epidemiological approaches to
biomarkers evaluation for early cancer detection and risk.

[]{#__RefHeading___Toc124236914 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Mr. Michael Weingartenr

National Cancer Institute

31 Center Drive, MSC 2580

Room 10A52

Bethesda, MD 20892

\(301\) 496-1550

Email: <weingartenm@mail.nih.gov>

Website: [http://otir.nci.nih.gov/smallbusiness/
small_sbir.html](http://otir.nci.nih.gov/smallbusiness/small_sbir.html)

Center to Reduce Cancer Health Disparities\
<http://crchd.nci.nih.gov/>

Dr. Emmanuel A. Taylor

National Cancer Institute

Center to Reduce Cancer Health Disparities

6116 Executive Blvd, Suite 602, Rm. 6045

Rockville, MD 20852-8341

\(301\) 594-6624, Fax: (301) 435-9225

Email: <taylorem@mail.nih.gov>

Division of Cancer Biology\
[http://dcb.nci.nih.gov](http://dcb.nci.nih.gov/)

Ms. Anne Heath

National Cancer Institute

Division of Cancer Biology

6130 Executive Blvd., EPN 5001

Bethesda, MD 20892-7385

\(301\) 480-435-5226, Fax: 301-480-2854

Email: <ah43v@nih.gov>

Division of Cancer Control and Population Sciences\
<http://dccps.nci.nih.gov/>

*[Cancer Epidemiology and Genetics]{.underline}*

<http://epi.grants.cancer.gov/>

Mr. Jay Choudhry

National Cancer Institute

6130 Executive Boulevard, Room 5109

Bethesda, MD 20892

\(301\) 435-6613, Fax: (301) 402-4279

Email: <choudhrj@mail.nih.gov>

*[Multimedia Technology and Health Communication in Cancer
Control]{.underline}*

<http://cancercontrol.cancer.gov/hcirb/sbir/>

Ms. Connie Dresser

National Cancer Institute

6130 Executive Boulevard, Room 4072

Bethesda, MD 20892-7365

\(301\) 435-2846, Fax: (301) 480-2087

Email: <cd34b@nih.gov>

Division of Cancer Treatment and Diagnosis\
<http://cancer.gov/dctd/>

*[Cancer Diagnosis Program]{.underline}*

<http://www.cancerdiagnosis.nci.nih.gov/>

Dr. James V. Tricoli

National Cancer Institute

6130 Executive Boulevard, Room 6026

Bethesda, MD 20892

\(301\) 496-1591, Fax: (301) 402-7819

Email: <tricolij@mail.nih.gov>

*[Biochemistry and Pharmacology]{.underline}*

[http://dtp.nci.nih.gov]()

Dr. George S. Johnson

National Cancer Institute

6130 Executive Boulevard, Room 8152

Bethesda, MD 20892-7456

\(301\) 496-8783, Fax: (301) 402-5200

Email: <johnsong@exchange.nih.gov>

*[Cancer Therapy Evaluation Program]{.underline}*

<http://ctep.cancer.gov/>

Dr. Roy S. Wu

National Cancer Institute

6130 Executive Boulevard, Room 7015

Bethesda, MD 20892

\(301\) 496-8866, Fax: (301) 480-4663

Email: <rw51j@nih.gov>

*[Cancer Imaging Program]{.underline}*

<http://cip.cancer.gov/>

Dr. Keyvan Farahanil

National Cancer Institute

6130 Executive Boulevard, Room EPN 3006

Bethesda, MD 20892-7412

\(301\) 451-2651, Fax: (301) 480-4631

Email: <farahani@nih.gov>

*[Radiation Research Program]{.underline}*

<http://www3.cancer.gov/rrp/>

Dr. Helen B. Stone

National Cancer Institute

6130 Executive Blvd., Room EPN 6010

Bethesda, MD 20892-7440

\(301\) 496-9360, Fax: (301) 480-5785

Email: <stoneh@exchange.nih.gov>

*[Biological Response Modifiers]{.underline}*

<http://web.ncifcrf.gov/>

Dr. Karen Muszynski

Biological Resources Branch

National Cancer Institute-FCRDC

P. O. Box B Building 1052 Room 253

Frederick MD 21702-1201

\(301\) 846-1101, Fax: (301) 846-5429

Email: <muszynskik@mail.ncifcrf.gov>

Division of Cancer Prevention\
<http://www.cancer.gov/prevention/>

*[Cancer Biomarkers Research Group]{.underline}*

Dr. Paul Wagner

National Cancer Institute

6130 Executive Boulevard, Room EPN 3140

Bethesda, MD 20892-7346

\(301\) 496-9424, Fax (301) 402-8990

Email: <wagnerp@mail.nih.gov>

*[Nutritional Science Research Group]{.underline}*

Dr. Sharon Ross

National Cancer Institute

6130 Executive Boulevard, Room EPN 3157

Bethesda, MD 20892-7328

\(301\) 594-7547, Fax (301) 480-3925

Email: <rosssha@mail.nih.gov>

For administrative and business management questions, contact:

Mr. Ted Williams

Grants Management Specialist

National Cancer Institute

6120 Executive Blvd, Rm. 243

Bethesda, MD 20892

\(301\) 496-8785, Fax: (301) 496-8601

Email: <tw133b@nih.gov>

For NCI-related SBIR Information, visit:
<http://www3.cancer.gov/admin/gab/index.htm>

[]{#__RefHeading___Toc124236915 .anchor}National Institute of Child
Health and Human Development (NICHD)

The NICHD conducts and supports research and research training on
biological and behavioral aspects of human development. Primary program
areas include: reproduction and population studies, pregnancy, perinatal
biology, maternal and infant well-being, developmental and reproductive
immunology, congenital defects, developmental biology, teratology,
nutrition and growth, human learning and behavior, learning
disabilities, cognitive and social development, mental retardation and
developmental disabilities, pediatric, adolescent, and maternal AIDS and
HIV, obstetric and pediatric pharmacology, and medical rehabilitation.

For additional information about areas of interest to the NICHD, please
visit our home page at
[http://www.nichd.nih.gov](http://www.nichd.nih.gov/).

[]{#__RefHeading___Toc124236916 .anchor}Phase II Competing Renewal
Awards

(See <http://grants.nih.gov/grants/guide/pa-files/PA-06-029.html> STTR
and <http://grants.nih.gov/grants/guide/pa-files/PA-06-030.html> SBIR.)

NICHD will accept Phase II SBIR/STTR Competing Renewal grant
applications to continue the process of developing products that require
approval of a Federal regulatory agency (e.g., FDA, FCC). Such products
include, but are not limited to: medical implants, drugs, vaccines, and
new treatment or diagnostic tools that require FDA approval. This
renewal grant should allow small businesses to get to a stage where
interest and investment by third parties is more likely. Applicants who
received either NICHD SBIR/STTR Phase I or Phase II support and who are
currently Phase II awardees are eligible.

You are strongly encouraged to contact Dr. Louis Quatrano (contact
information provided below) before beginning the process of putting a
Phase II Competing Renewal application together. Prospective applicants
are strongly encouraged to submit to the program contact a letter of
intent that includes the following information:

-   Descriptive title of the proposed research

-   Name, address, and telephone number of the Principal Investigator

-   Names of other key personnel

-   Participating institutions

-   Funding Opportunity Announcement Number (e.g., PA-06-XXX)

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 NIH staff to estimate the potential review
workload and plan the review. It is expected that only a portion of
NICHD SBIR/STTR Phase II awards will be eligible for a Competing Renewal
grant.

Examples of research that would be considered responsive to this
announcement are listed below for illustrative purposes and are not
exclusive of other appropriate activities. Preclinical studies,
including pharmacology and toxicology, and other clinical studies beyond
those conducted under the initial Phase II (R42, R44) grants such as:

-   innovative assistive devices and techniques to minimize residual
    disability and to impact on critical illness, physical behavior and
    cognitive development in childhood;

-   novel assays, kits, and devices to monitor fertility;

-   new and improved methods of fertility regulation, for men and for
    women, that are safe, effective, inexpensive, reversible, and
    acceptable;

-   new tools to monitor the state of various organ systems during
    therapy in pregnancy or infancy; and,

-   Evaluation of neuroimaging tools specific to brain development in
    pediatric populations or individuals with injuries.

Direct your questions about scientific/research issues to:

Louis A. Quatrano, Ph.D.

National Institute of Child Health and Human Development

\(301\) 402-4221, Fax: (301) 402-0832

Email: <lq2n@nih.gov>

[]{#__RefHeading___Toc124236917 .anchor}Population Research

Research on topics in reproductive sciences, contraceptive development,
and demographic and behavioral sciences. Examples of research topics
that may be of interest to small businesses include, but are not limited
to:

A. ***[Reproductive Sciences.]{.underline}*** Research on the
reproductive processes of men and women and of animals with similar
reproductive systems related to developing safer and more effective
means of regulating, preserving or achieving fertility. Particular areas
of programmatic interest relative to small business initiatives include,
but are not limited to:

1\. Development of reagents to facilitate study of reproductive and
developmental processes.

2\. Development of improved methods of growing and differentiating stem
cell lines in vitro, including feeder cell-free approaches.

3\. Development of novel assays, kits, and devices to monitor fertility
and treat infertility and gynecological disorders.

4\. Use of genomics and proteomics to develop novel diagnostics and
treatments for reproductive diseases and disorders.

5\. Development of high resolution technologies to provide invasive or
noninvasive assessments of reproductive and developmental competence.

6\. Development of experimental animal models that would be useful for
studying the physiology and pathophysiology of reproductive processes.

7\. Development of improved and novel technologies for the preservation
of human gametes.

8\. Development of improved technologies for preimplantation genetic
diagnosis.

9\. Development of improved technologies for the reprogramming of cells,
including embryonic stem cells or adult cells, into eggs and sperm.

Dr. Susan Taymans

\(301\) 496-6517, Fax: (301) 496-0962

Email: <taymanss@mail.nih.gov>

B. ***[Contraception and Reproductive Health Research.]{.underline}***
Emphasis is on developing new and improved methods of fertility
regulation; developing new and improved treatments for disorders of the
reproductive system including female pelvic floor disorders; and
research on the benefits and risks of contraceptives and other drugs,
devices, and surgical procedures as they affect reproductive health.
Areas of interest include, but are not limited to:

1\. Developing new and improved methods of fertility regulation, for men
and for women that are safe, effective, inexpensive, reversible, and
acceptable. This includes, but is not limited to, synthesis and testing
of novel chemical compounds.

2\. Developing new and improved treatments for disorders of the male and
female reproductive system, including those used for hormone therapy and
drugs, graft materials, and devices used for non-surgical and surgical
treatment of pelvic organ prolapse, urinary incontinence, and other
female pelvic floor disorders.

3\. Discovering and disseminating new knowledge about the medical
benefits and risks of contraceptives and other drugs, devices, and
surgical procedures affecting reproductive health. We will primarily
support applied research projects such as epidemiologic studies or Phase
III/IV trials designed to detect clinically significant adverse effects,
particularly those too rare to be determined through the FDA\'s
premarketing approval process. Laboratory models will be used when human
studies are not feasible or to explore mechanisms of action or
supplement epidemiologic and clinical observations.

4\. Studies relating contraception or reproductive health to STDs such
as HIV, including but not limited to development of new products with
microbicidal activity against STDs such as HIV; studies to define the
relationships among contraceptive methods and HIV acquisition,
transmission, or disease progression; development of diagnostic and
other research models for HIV and contraception/reproductive science;
and studies to clarify mechanism of interaction between contraceptives
and other disease processes or conditions.

Dr. Steven Kaufman

\(301\) 435-6989, Fax: (301) 480-1972

Email: <sck@nih.gov>

C. ***[Demographic and Behavioral Sciences.]{.underline}*** Research on
the size, growth, and composition of populations and the impact of
changes in population on the health and well-being of individuals,
families, and the population itself. The program emphasizes not only
factors affecting fertility, mortality, population movement and
compositional change, but also teenage childbearing, AIDS, single-parent
families, racial and ethnic differentials in infant mortality, legal and
undocumented immigration, and the well-being of children. Applications
are encouraged in these areas:

1\. Innovative use of geographical information systems and spatial
network analysis.

2\. Innovative approaches to analyzing and disseminating large-scale
data sets.

3\. Development of effective tools for prevention research and
intervention programs related to STD/HIV, pregnancy, divorce, child
health, and other mission-related topics.

4\. Innovative approaches to teaching population studies and other
behavioral and social sciences at the undergraduate and graduate level.

5\. Innovative approaches for research design, data collection
techniques, measurement, and data analysis techniques in the social and
behavioral sciences, with particular attention to methodology and
measurement issues in studying diverse populations, sensitive behaviors,
confidential behaviors; in issues related to the protection of research
subjects; and in issues related to the archiving and disseminating
complex datasets.

Dr. Rebecca L. Clark

\(301\) 496-1175, Fax: (301) 496-0962

Email: <rclark@mail.nih.gov>

[]{#__RefHeading___Toc124236918 .anchor}Research for Mothers and
Children

Research in three major program areas includes: learning disabilities;
cognitive and social development; nutrition and growth; obstetric and
pediatric pharmacology, and pediatric, adolescent, and maternal AIDS.
Topics that may be of interest to small businesses include, but are not
limited to, those identified below.

A. ***[Child Development and Behavior.]{.underline}*** Research and
research training programs in developmental psychology (cognitive,
affective, and social development), cognitive psychology, cognitive
neuroscience, language acquisition and bilingualism, developmental
neuropsychology, behavioral pediatrics, and educational psychology;
studies to define, classify, and map the developmental course of
specific learning disabilities and disorders of attention; studies to
elucidate the etiological role of cognitive, linguistic, perceptual,
educational, genetic, social, and neurobiological mechanisms in
dyslexia, mathematical disabilities, learning disabilities, language
disorders, and disorders of attention; investigations of the effects of
well-defined treatment interventions on specific types of learning
disabilities; studies designed to understand the development of
attention, reasoning, planning, problem solving, and concept formation
in children; basic and intervention research in mathematics and science
cognition and learning; studies delineating the effects of motivation,
emotion, societal, cultural, familial, and neurobiological influences on
social, emotional, and cognitive development; examinations of the
effects of parental and non-parental care on social, emotional, and
cognitive developmental outcomes; and investigations of temperament,
motivation, self-concept, attitudes, and values, and their relationship
to development. Research and development of neuroimaging tools specific
to brain development in pediatric populations, including research or
tool development using EEG, magnetic resonance imaging (MRI), functional
MRI, magnetic spectroscopy (MRS), diffusion tensor imaging (DTI), and
near infrared spectroscopy. Biobehavioral research on preventive
measures for injuries and risk behaviors (alcohol, tobacco, other
illicit drug use, sexual risk behaviors, gambling, suicide, and
antisocial behavior). The development of training programs (CD-ROM,
website, etc.) and research designed to promote health (physical
activity, spirituality, adherence to medical and therapeutic regimens,
and mind-body) and prevent diseases and unhealthy conditions (HIV,
sexually transmitted diseases, obesity, eating disorders, pain, stress,
and sleep disorders). Research and development projects on assessments
tools for use in child outcomes assessment, processes of interaction
between children and parents and other caregivers, and tools for use in
measuring environmental and other contextual factors in development, and
the application of technology to aid in conducting these assessments.

Dr. Reid Lyon

\(301\) 496-9849, Fax: (301) 480-0230

Email: <rl60a@nih.gov>

B. ***[Endocrinology, Nutrition, and Growth.]{.underline}*** Research on
the nutritional needs of pregnant women and their fetuses; aspects of
nutrients related to reproduction, growth, and development; breast
feeding and lactation; the immunology of breast milk; development of the
gastrointestinal system; childhood obesity and the nutritional
antecedents of adult disease; developmental endocrinology; mechanisms of
hormone action during growth and development, and the impact of
hormonally active agents in the environment on growth and development.
Applications to advance the study of obstetric and pediatric
pharmacology include: Research and tools to better characterize the
impact of physiological and developmental changes on pharmacokinetics
and pharmacodynamics; advancements in modeling which improve therapy
during pregnancy, among premature infants, children and adolescents;
research on tools to monitor the state of various organ systems during
therapy in pregnancy or infancy; such as, cerebral monitors, placental
function, etc.; models to characterize molecular, dosing or other
modification to improve therapy.

Dr. Gilman D. Grave

\(301\) 496-5593, Fax: (301) 480-9791

Email: <gg37v@nih.gov>

C. ***[Pediatric, Adolescent, and Maternal AIDS.]{.underline}***
Research on all aspects of HIV (human immunodeficiency virus) infection
and disease, including AIDS in women of child-bearing age, pregnant
women, mothers, fetuses, infants, children, and adolescents. Areas of
interest include, but are not limited to, epidemiology, natural history,
pathogenesis, treatment, and prevention.

Dr. Robert Nugent

\(301\) 435-6871, Fax: (301) 496-8678

Email: <rn22e@nih.gov>

[]{#__RefHeading___Toc124236919 .anchor}Developmental Biology &
Perinatal Medicine Research

Research in three major program areas includes: pregnancy and
Perinatology; developmental biology, genetics and teratology; and mental
retardation and developmental disabilities. Topics that may be of
interest to small businesses include, but are not limited to, those
identified below.

A. ***[Pregnancy and Perinatology.]{.underline}*** Research on the
physiology of pregnancy and labor; high-risk pregnancies, including
those with hypertensive disorders, diabetes or seizure disorders; fetal
pathophysiology; premature labor and birth; diagnostic, monitoring, and
therapeutic devices and instruments for newborn infants in the nursery
and in Neonatal ICU setting; improving the existing products or
developing new products that would improve the routine and extended care
of the newborn infants; products and agents related to breastfeeding;
hospital supplies specifically related to use in the care of newborn
infants; nanotechnology and its application for the care of newborn
infants; instruments and devices assessing and monitoring the nursery
environment (noise, lighting, and odor); disorders of the newborn;
sudden infant death syndrome; and biological and behavioral antecedents
of low birth weight.

Dr. Tonse Raju

\(301\) 496-5575, Fax: (301) 496-3790

Email: <rajut@mail.nih.gov>

B. ***[Development Biology, Genetics, and Teratology.]{.underline}***
Biomedical research on the cellular, molecular, and genetic aspects of
normal and abnormal embryonic and fetal development and its aberrations,
including early embryogenesis, limb formation, development of the
nervous system, developmental and reproductive immunology, and causative
factors in teratogenesis. Applications to develop and apply new animal
model systems or innovative and high throughput genomic and proteomic
technologies to advance the study of embryonic development, structural
birth defects, and newborn screening are particularly welcome.

Dr. Lorette Javois

\(301\) 496-5541, Fax: (301) 480-0303

Email: <lj89j@nih.gov>

C. ***[Mental Retardation and Developmental
Disabilities.]{.underline}*** Biomedical research in neuroscience,
genetics, biochemistry, molecular biology, and psychobiology aimed at
identifying factors that cause abnormal brain maturation and function;
identification of direct and indirect social, economic and cultural
influences on the occurrence of mental retardation and developmental
disabilities (MRDD); and research leading to the assessment, prevention,
and amelioration of MRDD, including screening and prenatal diagnosis.

Dr. Mary Lou Oster-Granite

\(301\) 496-1383, Fax: (301) 496-3791

Email: <mo96o@nih.gov>

[]{#__RefHeading___Toc124236920 .anchor}Medical Rehabilitation Research

This Center supports innovative research on the restoration,
replacement, enhancement or adaptation of function for people with
chronic physical disabilities. This includes rehabilitative approaches
across etiologies and the lifespan, as well as the environmental and
policy factors that promote full participation. We encourage studies
that integrate biomedical, engineering and/or psychosocial approaches to
develop practical and creative solutions to the daily functioning of
people with disabilities and their families. The mission of the NCMRR is
to increase the effectiveness of medical rehabilitation practices
through research. Information about specific program areas within NCMRR
can be found at: [http://www.nichd.nih.gov/about/ncmrr/
ncmrr.htm](http://www.nichd.nih.gov/about/ncmrr/ncmrr.htm). Examples may
include:

A. Improving functional mobility.

B. Promoting behavioral adaptation to functional losses.

C. Assessing the efficacy and outcomes of medical rehabilitation
therapies and practices.

D. Developing improved assistive technology.

E. Promoting rehabilitative outcomes in pediatric critical care.

F. Understanding whole body system responses to physical impairments and
functional changes.

G. Developing more precise methods to measure impairments, disabilities,
and societal limitations.

H. Training health professionals in the field of medical rehabilitation.

I. Enabling technologies for restoration of function.

J. Promoting profession structured/directed self care and wellness.

Investigators proposing budgets exceeding the guidelines should contact
program six weeks prior to submitting the application. Study section
approval of projects exceeding the guidelines may not be supported at
the level requested.

For additional information on research topics, contact:

Nancy Shinowara, Ph.D.

\(301\) 495-6838, Fax: (302) 402-0832

Email: <shinowan@mail.nih.gov>

or

Dr. Louis A. Quatrano

\(301\) 402-4221, Fax: (301) 402-0832

Email: <lq2n@nih.gov>

[]{#__RefHeading___Toc124236921 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Louis A. Quatrano, Ph.D.

National Institute of Child Health and Human Development

\(301\) 402-4221, Fax: (301) 402-0832

Email: <lq2n@nih.gov>

For administrative and business management questions, contact:

Mr. J. Chris Robey

Grants Management Branch

National Institute of Child Health and Human Development

\(301\) 435-6996, Fax: (301) 402-0915

Email: <robeyj@nih.gov>

[]{#__RefHeading___Toc124236922 .anchor}National Institute on Drug Abuse
(NIDA)

The mission of the NlDA is to lead the nation in bringing the power of
science to bear on drug abuse and addiction, through support and conduct
of research across a broad range of disciplines and by ensuring rapid
and effective dissemination and use of research results to improve
prevention, treatment, and policy. For additional information about
areas of interest to the NIDA, please visit our home page at
<http://www.nida.nih.gov/>.

[]{#__RefHeading___Toc124236923 .anchor}Phase II Competing Renewal
Awards

(See <http://grants.nih.gov/grants/guide/pa-files/PA-06-036.html> SBIR)

NIDA will accept Phase II SBIR Competing Renewal grant applications to
continue the process of developing products that require approval of a
Federal regulatory agency. Such products include, but are not limited
to: medical implants, drugs, vaccines, and new treatment or diagnostic
tools that require FDA approval. This renewal grant should allow small
businesses to get to a stage where interest and investment by third
parties is more likely.

Please contact Dr. Cathrine Sasek (contact information provided below)
before beginning the process of putting an application together.
Prospective applicants are also strongly encouraged to submit to the
program contact a letter of intent that includes the following
information:

-   Descriptive title of the proposed research

-   Name, address, and telephone number of the Principal Investigator

-   Names of other key personnel

-   Participating institutions

-   Funding Opportunity Announcement Number (e.g., PA-06-XXX)

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 NIH staff to estimate the potential review
workload and plan the review. It is expected that only a portion of NIDA
SBIR Phase II awards will be eligible for a Competing Renewal grant.

The following examples would make appropriate topics for proposed SBIR
Phase II Competing Renewal projects. These are meant for illustrative
purposes only and are not exclusive of other appropriate activities.

Research and development efforts can be focused on medications for the
treatment of cocaine, methamphetamine, and other stimulant abuse, as
well as towards opiate, cannabis, PCP and club drugs. The medications
under development should be targeted towards attainment of abstinence,
maintenance, and/or relapse prevention.

-   Preclinical studies, including pharmacology and toxicology, beyond
    those conducted under the initial SBIR Phase I and Phase II grants.
    The studies conducted under the previous grants should be sufficient
    to provide a sound rationale for continued development of the entity
    or entities.

-   Completion of studies as required by the FDA for an IND application.

-   Human laboratory clinical trials to determine a medication\'s safety
    profile, metabolism, cardiovascular effects, interaction with drugs
    of abuse, etc.

-   Clinical studies to assess the efficacy of the medication under
    development.

Cathrine Sasek, Ph.D.

National Institute on Drug Abuse

6001 Executive Boulevard

Room 5230, MSC 9591

Bethesda, Maryland 20892-9591

\(301\) 443-6071, Fax: (301) 443-6277

Email: <csasek@nih.gov>

[]{#__RefHeading___Toc124236924 .anchor}Division of Pharmacotherapies &
Medical Consequences of Drug Abuse

The NIDA Division of Pharmacotherapies & Medical Consequences of Drug
Abuse (DPMCDA) supports research aimed at the development and testing of
pharmacological and behavioral treatments for drug abuse and addiction.
This includes the identification, evaluation, development,
approvability, and efficacy testing of new and improved
pharmacotherapeutic agents, as well as the testing of marketed
medications, and of behavioral treatments used alone or integrated with
medications. The DPMCDA also advances a human neuroscience research and
training program focused on understanding the neurobiological substrates
of drug abuse and addiction processes.

A. ***[Chemistry and Pharmaceutics Branch (CPB).]{.underline}*** The CPB
supports research in the design (including molecular modeling and
structure-activity relationship studies) and synthesis of novel
compounds, formulation development, bioanalytical methods development,
and pharmacokinetics/ pharmacodynamics aimed at the discovery and
development of new medications for treating drug addiction. Areas that
may be of interest to small businesses include, but are not limited to
*[research related to the design and development of new compounds and
improved drug products (drug delivery) for the treatment of drug
addiction]{.underline}*:

1\. Synthesis (either using traditional or combinatorial techniques) or
discovery (natural products) of new chemical compounds that would have
potential as treatment agents for the medical management of stimulant
(e.g., cocaine, methamphetamine, or nicotine) addiction. Consideration
should be given to the design of partial agonists or pure antagonists
that diminish the reinforcing effects of stimulants, as well as full
agonists that could function to normalize physiological activity
following discontinuation of stimulant use.

Compounds of interest include those that are designed to affect
dopaminergic (i.e., D1 agonists, D3 agonists and D3 antagonists)
activity, CRF antagonists, compounds affecting glutamate activity,
GABAergic activity, small molecule neuropeptide antagonists and
compounds acting through other mechanisms for which justification has
been supplied.

2\. Synthesis (either using traditional or combinatorial techniques) of
new chemical compounds that would have potential as treatment agents for
the medical management of cannabinoid abuse.

3\. Development of new immunotherapeutic treatments that would have the
potential as treatment agents for stimulant, opioid or cannabinoid
abuse.

Richard Kline, Ph.D.

\(301\) 443-8293

Email: <rk108@nih.gov>

4\. Development of new approaches for the administration of potential
addiction treatment drugs with poor bioavailability.

5\. Development of controlled release dosage forms for addiction
treatment medications in order to maintain therapeutic drug levels for
extended periods of time to alleviate compliance problems associated
with addiction treatment.

Moo Park, Ph.D.

\(301\) 443-5280

Email: <mp264a@nih.gov>

B. ***[Medications Discovery and Toxicology Branch
(MDTB).]{.underline}*** The MDTB supports research on the development of
preclinical behavioral models (e.g., of craving, drug-seeking behavior,
dependence, or relapse), biochemical assays, gene expressional assays
and electrophysiological methods to identify and characterize new
medications to treat substance abuse, as well as pharmacological
screening of novel compounds to identify potential drug abuse
medications. The Branch also supports research on toxicity studies of
potential medications for the treatment of substance abuse, and
interactions of potential treatment medications with abused substances.
Areas that may be of interest to small businesses include, but are not
limited to *[development of new methods for discovery of medications
useful in treating drug addiction]{.underline}*. Of special interest
would be the development of new animal models of addiction,
incorporating established drug self-administration techniques that show
increased relevance to the clinical setting. Development of relevant
biochemical or electrophysiological screening methods is also
encouraged.

Jane B. Acri, Ph.D.

\(301\) 443-8489

Email: <ja96v@nih.gov>

C. ***[Medications Research Grants Branch (MRGB).]{.underline}*** The
MRGB supports investigations of the use of therapeutic agents (including
vaccines and monoclonal antibodies) for the treatment of substance
related disorders, with the aim of assisting in reducing drug use,
becoming drug free, prolonging abstinence, decreasing associated
psychosocial, medical or legal problems, or surviving drug overdose. In
general, therapeutic agents are expected to be investigated using a
platform of appropriate psychosocial interventions. The program funds
extramural grants in the following:

-   Clinical trials to test the safety, find the optimal dose, and/or
    obtain preliminary efficacy data for new agents or new indications
    of marketed medications. This phase includes interaction studies to
    test the safety of the agent when used in combination with drugs of
    abuse.

-   Clinical trials to assess the efficacy of new agents or marketed
    medications for the treatment of substance related disorders. In
    general, these types of trials use a randomized double blind placebo
    controlled design.

-   Clinical studies of the efficacy of medications for the treatment of
    the comorbidity of substance related disorders (e.g., alcohol and
    cocaine dependence) or the comorbidity of these disorders with other
    medical or psychiatric conditions.

-   Clinical evaluation of the efficacy of medications for the treatment
    of substance related disorders in specific groups of the population.
    For example, adolescents, the elderly, women of childbearing age,
    pregnant and/or postpartum women, as well as racial and ethnic
    minorities.

-   Evaluation of biological and/or psychosocial factors that may affect
    the outcome of the pharmacotherapy of substance related disorders.

Specific areas that may be of interest to small businesses include, but
are not limited to:

1\. *[Pharmacogenetics and Substance Use Disorders (SUD).]{.underline}*
The emergence of new genetic techniques may allow the use of genetic
information to improve the safety and efficacy of treatments. The field
of pharmacogenetics focuses on the genetic determinants of response to
medications and other therapies in humans and animals. The goal is to
discover novel single nucleotide polymorphisms (SNPs) and test their
relevance to the underlying genetic differences that determine the
safety and efficacy of medications for the treatment of SUD. It includes
the study of genes encoding drug metabolizing enzymes, transporters,
receptors and other drug targets, polygenic determinants of drug
disposition and effects in humans, the role of genes in the clinical
response to and medical safety of medications, and application of
genetic information to disease prevention and to optimize treatments in
humans. It also includes novel methods for phenotyping the diagnosis,
safety and treatment outcome of SUD. Ultimately, it is expected that
pharmacogenetics research will help clinicians to individualize the
treatment of their patients based on their genetic information. Research
is needed to study the genetic factors that may be associated with drug
abuse treatment safety and outcome.

2\. *[Medications Development for the Treatment of Drug Abuse in
Adolescents.]{.underline}* Drug abuse among adolescents is a significant
and growing public health concern. It is known that the pharmacokinetics
and pharmacodynamics of some medications are different in adolescents.
Therefore, adolescents may present overdoses, underdoses or lack of
efficacy, or different safety profiles when administered medications at
the doses studied only in adults. Unfortunately, little is known about
the safety and efficacy of medications for the treatment of drug abusing
adolescents because most of the drug abuse medication research has
focused on adults. Research is needed to test medications for the
treatment of nicotine and drug abuse in adolescents.

3\. *[Medications for the Treatment of Pregnant and Post-Partum Drug
Abusing Women and Their Children.]{.underline}* Little is known about
the safety and efficacy of medications for the treatment of substance
abusing pregnant women and their children. There is a need for safe and
effective medications for the treatment of nicotine and drug
abuse/dependence among pregnant and post-partum women and the effect of
these medications on their children. Research is also needed to study
the effects on the newborn of the medications taken by the mother and
medications for treatment of children born to substance abusing mothers
who may present drug withdrawal and other symptoms.

4\. *[Medications for the Treatment of Comorbid Medical or Mental
Disorders and Drug Abuse.]{.underline}* Co-morbid medical and
psychiatric conditions are frequently found among substance abusing
patients. Co-occurring mental disorders, such as depression,
post-traumatic stress disorder, and anxiety disorder, and medical
conditions such as hepatitis C, AIDS related disorders, and pain, are
common among substance abusing patients. Unfortunately, there are
presently no commonly prescribed safe and effective medications for the
treatment of substance abusing patients with other co-morbid medical and
psychiatric conditions. Research is needed to study the safety and
therapeutic profiles of medications for treatment of substance abuse in
patients with other comorbidities. There is also a need to study the
effects of medications for the treatment of substance use disorders in
patients taking medications for other comorbid conditions and the
necessary dose adjustments.

5\. *[Development of Software and/or Other Tools for Data Collection and
Statistical Analysis of Clinical Trials Testing the Safety and Efficacy
of Therapeutic Agents for the Treatment of Substance Related
Disorders.]{.underline}* Current data collection techniques often have
questionable validity and reliability and statistical data analysis pose
particular challenges. They range from lack of well defined outcome
measures to having a large amount of missing data, which may be due
intermittent missing data points to early subject drop out (attrition).
To solve those challenges, investigators have developed pragmatic
methods to analyze their data. For example, carry forward data from the
last timepoint, data replacement by regression, end point analysis by
regression, or worst case scenario, they all have important statistical
limitations. The purpose of this initiative is to stimulate research on
innovative data management tools to improve data collection and analysis
of data from nicotine and drug abuse clinical trials.

Ivan D. Montoya, Ph.D.

\(301\) 443-8639

Email: <imontoya@mail.nih.gov>

6\. *[Immunotherapy for Addiction Treatment.]{.underline}* The MRGB
supports research on the advanced stage development of monoclonal
antibodies and vaccines for the treatment of drug and nicotine addiction
and/or overdose. Monoclonal antibodies have been reported as possible
treatment agents through passive immunization for PCP, methamphetamine,
MDMA, and cocaine overdose and may also serve to minimize abuse and
prevent relapse. New vaccines are being developed as therapies for drug
or nicotine cessation and relapse prevention. New technologies, such as
the production of antibodies in plants, are emerging as cost-effective
and efficient ways for the large scale manufacture of immunotherapy
agents, represent another facet of this area for development.

Jamie Biswas

\(301\) 443-8096

Email: <jb168r@nih.gov>

[]{#__RefHeading___Toc124236925 .anchor}Division of Clinical
Neuroscience, Development and Behavioral Treatment (DCNDBT)

A. ***[Behavioral Therapy Development Research.]{.underline}*** The
Behavioral and Integrative Treatment Branch is particularly interested
in research on the development of new or refinement of existing
psychotherapies, behavioral therapies, skills training techniques or
drug counseling strategies for the treatment of drug abusers/addicts.
Incorporation of HIV risk reduction strategies is seen as an integral
component in routine counseling or other behavioral interventions for
drug abusers. Key products of this research would include the
development of: 1) therapy manuals, to define exactly what the therapy
is and how to administer it optimally; 2) competence and adherence
scales, to evaluate the extent to which therapists and counselors are
actually providing the therapy intended; 3) process measures, to measure
various aspects of the therapeutic interaction; and 4) measures of the
integrity and fidelity of the therapy. The use of technology in
developing, administering, and disseminating these products is
encouraged, including internet-based programs, CD-ROM technology, audio
delivery devices, photo therapeutic instruments, hand-held computers,
interactive computer programs, telemedicine, etc. The following topics
are of particular interest:

1\. *[Translation from Basic Behavioral or Cognitive
Science.]{.underline}* Development and testing of behavioral therapies
or components of such therapies that are based on developments and
findings from the basic behavioral or cognitive sciences.

2\. *[Translation of Cognitive and Affective Neuroscience Findings
Towards Development of Behavioral Treatments.]{.underline}* Recent
studies using neuroimaging and neuropsychological evaluations provide
ample evidence that chronic drug use is associated with neuroanatomical
changes that alter cognitive function and the ability to regulate
affective states. Further, these changes vary over time and may depend
on the current state of the individual (e.g., acute administration of
one or more drugs; during initial vs protracted abstinence). Such
comorbid conditions make it difficult for many chronic drug users to
engage in and participate meaningfully in efficacious behavioral drug
treatments. However, knowledge from neuroimaging and neuropsychological
studies has not yet been utilized to benefit the patient. In addition,
knowledge about fundamental cognitive and affective functioning even in
the intact brain, typically has not led to tools that can be used for
treating substance abuse. Thus, research that integrates basic research
findings on cognition (e.g., decision-making, problem-solving, learning,
memory, attention, motivation) and affect (e.g., anxiety, anger,
depression) in the following areas are encouraged: Development of
interventions to (a) reduce the negative impact of cognitive dysfunction
and affective dysregulation on drug use outcome; (b) prevent relapse;
(c) reduce the severity and course of the dysfunctions; (d) improve
specific areas of cognitive and affective functioning; and (e) improve
daily functioning in addition to reducing clinical symptoms. Other goals
of this initiative are to: develop reliable and valid methods for
assessing basic cognitive and affective processes as part of clinical
diagnosis; evaluate cognitive and affective functioning as indicators of
risk for exacerbated drug use during treatment or for developing other
disorders; determine if and how current efficacious treatments
rehabilitate altered cognitive and affective functioning; modify and
test current efficacious treatments tailored to the needs of cognitively
impaired individuals.

3\. *[Treatment of Sleep Disorders for Individuals in Drug Abuse
Treatment.]{.underline}* Recent research on sleep has shed new light on
its importance to psychological and physical health. Sleep deprivation
has been linked with impaired cognitive performance, negative mood, and
even decreased immune function. Drug abusers often cite insomnia as
reason for relapse, and may use drugs to modulate their sleep/waking
cycles. However, the treatment of sleep disorders has not been a primary
focus of drug abuse treatment research. The development and testing of
sleep hygiene interventions for use in conjunction with drug abuse, as a
means of improving treatment for drug abuse is needed. Developmentally
appropriate treatment of sleep disorders could impact on the development
of more effective treatment interventions.

4\. *[Modifying Efficacious Behavioral Treatments to be Community
Friendly]{.underline}*. Several behavioral interventions have been found
to be efficacious for the treatment of drug addiction. However, there
are barriers to implementation of behavioral therapies in
community-based settings. Community settings that treat drug addicted
individuals are reluctant or unwilling to adopt these interventions for
a variety of reasons. Reasons that scientifically-based behavioral
treatments are not accepted by community providers could include the
excessive cost of implementation, the length of time for administration
of treatment, inadequate training available for therapists and
counselors, treatments not shown to be generalizable for different
patient populations or for polydrug abusing populations, etc. Research
aimed at modifying efficacious behavioral treatments to make them more
acceptable to community settings is needed. Settings might include, drug
abuse treatment facilities, primary care, managed care, and the criminal
justice system. Examples of possible studies are those that are designed
to reduce the cost of implementation of treatments, reduce the time of
administration of treatments, aid in training of therapists, counselors
and nurses, adapt individual therapies for group situations, etc.

5\. *[Treatment for Emerging or Specific Populations.]{.underline}*
Therapies designed to intervene with understudied populations including
users of drugs such as methamphetamine, MDMA and other club drugs,
marijuana, and inhalants, as well as personality disordered drug
abusers.

6\. *[Treatment to Prevent Escalation from Abuse to
Dependence.]{.underline}* Therapies for drug abusers who are not yet
dependent on drugs to reduce risk of escalation to dependence and
therapies for drug abusers who have not considered or claim little
interest in seeking treatment for their drug problems. For these
populations treatments are needed which interest and engage the
potential client and intervene with them. Treatments for participants in
their natural environment, such as treatments delivered over the
Internet or in neighborhood settings such as churches and recreation
centers are desired.

7\. *[Improving Adherence to Medications and Treatment for Drug Abusers
with HIV/AIDS.]{.underline}* The introduction of highly active
antiretroviral therapy (HAART) has significantly changed HIV/AIDS
clinical care. Drug abusers account for a substantial proportion of AIDS
cases in the United States, yet have received disproportionately less
benefit from highly active antiretroviral therapy than have non drug
abusers. Recent studies have shown that HAART is underutilized among
drug abusers, and that individuals who continue to abuse drugs may be
less likely to achieve the level of adherence necessary to maintain
viral suppression than non-drug abusers. There is a need for research
related to the development and evaluation of new and improved behavioral
treatments (alone, and in combination with pharmacological treatments
for drug addiction), in order to facilitate better adherence to
antiviral regimens among drug abusers with HIV infection and also among
HIV positive drug abusers who have comorbid mental and/or psychiatric
disorders. In the development of behavioral treatment approaches to
improve adherence, increased attention to the unique needs of drug
abusing women, men who have sex with men, adolescents, and racial/ethnic
minority populations is needed. The development and evaluation of
innovative medication adherence strategies for HIV positive drug abusers
should address issues related to cognitive impairment, emotion
regulation, impulsivity, decision-making, motivation, and social and
cultural influences. To enhance the utilization of efficacious
approaches to improving medication adherence in drug abusers with HIV
infection, there is also a need to develop and evaluate treatments
administered or assisted by technological devices such as computers, the
internet, expert system models, telephone pagers, or hand-held
computers.

Lisa Onken, Ph.D.

\(301\) 443-2235

Email: <l010n@nih.gov>

8\. *[Behavioral Strategies for Increasing Compliance in Taking
Treatment Medication]{.underline}*. Research to develop and to evaluate
strategies to induce recovering addicts to take medication for a
prolonged time, especially antagonists such as Naltrexone; to induce HIV
infected drug users to comply with medical treatments (HAART) in drug
abuse treatment settings; or to adapt existing behavioral strategies to
increase patient compliance and cooperation in long-term treatment for
drug abuse or for diseases associated with drug abuse such as
tuberculosis or hepatitis. An important consideration should be cost and
practicality of use in actual clinical practice or in an aftercare
program. The product of such research might be a manual, which describes
the behavioral strategy, and its implementation by treatment staff or
scientific data regarding evaluation.

9\. *[Integration of Behavioral Therapies and
Pharmacotherapies]{.underline}*. Development of integrated behavioral
therapies and pharmacotherapies may enhance the efficacy of both types
of therapeutic interventions. For instance, the maintenance and
detoxification of heroin addicts could perhaps be optimized by the
integration of distinctive behavioral therapies devised specifically for
opioid agonists, antagonists or partial agonists determined by the
heterogeneity of the subgroup of addicts and the pharmacological
differences of the medications. Integration of medications and
behavioral therapies could possibly enhance compliance with medication
regimens, *[increase]{.underline}* retention allowing pharmacological
effects to occur and prevent relapse to drug abuse and addiction.

10\. *[Treatment Modules for Specific Problems or
Populations.]{.underline}* Discrete therapy components that address
specific problems common among drug addicted individuals and that can be
implemented in conjunction with other therapeutic services. For example,
an investigator may wish to develop a four session, highly focused, job
seeking skills module that can be easily implemented by a wide range of
practitioners to effectively increase appropriate job seeking behavior.
Other examples include, but are not limited to, modules to engage
ambivalent drug dependent individuals in treatment, modules to increase
assertiveness in female drug addicts who feel pressured by others to use
drugs, or to incorporate effective HIV risk reduction techniques.

11\. *[Behavioral Treatment Research for Drug Abuse and Addiction in
Primary Care]{.underline}*. Recent research has shown that physicians
and other clinicians often fail to recognize drug abuse or addiction
among their primary care patients. In addition, a significant number of
these clinicians reported that they did not know how to intervene with
their patients if drug abuse or addiction was suspected. Drug abuse
related illnesses and morbidity often occur in adults and may have begun
in adolescence. However, very little research has been done to develop
or test behavioral treatment approaches or combined pharmacological and
behavioral treatments for drug abuse and addiction in primary care
settings. The objectives of this initiative are to encourage research on
the development and testing of innovative brief behavioral treatment
approaches, alone or in combination with pharmacological treatments that
may be used in various primary care patient populations and primary care
settings. Other goals of this research initiative are to encourage
additional research on the development and evaluation of culturally
sensitive screening and assessment instruments for use in primary care;
and to encourage research on the transportability of efficacious
behavioral treatments to primary care settings, as well as research on
science-based training approaches for changing primary care clinicians\'
behaviors regarding their recognition and intervention with drug abusing
or addicted patients. While motivational enhancement approaches for some
drug abusing populations have been found to be effective, this
behavioral approach has not been widely used in primary care.

12\. *[Using Telemedicine to Disseminate Drug Addiction Research
Findings to Primary Health Care Providers]{.underline}*. Telemedicine
programs are being used in urban medical centers to rapidly disseminate
science-based information on new medical treatments. In addition,
approximately one-third of the rural hospitals are now using
telemedicine to improve patient care. Health care professionals need
science-based information on drug abuse prevention and treatment.
Research to develop and evaluate telemedicine programs to transport
science-based information on drug addiction to the primary health care
community is encouraged.

13\. *[Developing, Evaluating, and Transporting Culturally Sensitive
Behavioral Therapies for Racial and Ethnic Minorities]{.underline}*.
Minority populations are disproportionately affected by the consequences
of drug abuse. Research to develop and evaluate behavioral treatments
that are culturally sensitive and relevant for diverse racial and ethnic
minority populations is encouraged. This may include studies of
behavioral treatments, alone or in combination with pharmacological
treatment, or studies of behavioral strategies for increasing adherence
to taking medications. In the development and evaluation of the
behavioral treatment, attention needs to be directed at examining
medical, social, and cultural factors that may influence adherence to
the behavioral treatment approach and treatment outcome. Also, little is
known about the transportability of efficacious behavioral treatments
for minority populations. Research is needed on how to transport
science-based treatments to various racial/ethnic populations.

Dorynne Czechowicz, M.D.

\(301\) 443-0107

Email: <dc97d@nih.gov>

14\. *[Incorporating Smoking Cessation in Drug Abuse
Treatment]{.underline}*. Research is encouraged to develop and test
behavioral and combined behavioral and pharmacological treatments for
nicotine-addicted individuals who also are addicted to other substances,
such as heroin, cocaine, methamphetamines and alcohol. Prevalence of
cigarette smoking is extremely high among drug dependent individuals
attending drug treatment. Many treatment providers are reluctant to
address smoking cessation with clients either because they believe that
substance abusers are not interested in quitting or because they fear
smoking treatment will have a negative impact on drug abuse treatment
outcome. However, studies have shown that many drug abuse clients are
interested in quitting smoking and that the concurrent treatment of
tobacco dependence and other drug dependencies does not threaten
abstinence and might even assist in maintaining it. Research is needed
to develop and test smoking cessation treatments that can be
incorporated into treatments for illicit drugs of abuse.

15\. *[Developing Treatments for Smokers with Comorbid
Disorders]{.underline}*. Research is encouraged that focuses on the
development, refinement, and testing of behavioral treatments for
smokers with psychiatric comorbidity, such as depression, schizophrenia,
or anxiety disorders. Smoking prevalence is very high in individuals
with psychiatric disorders. These populations generally respond poorly
to traditional smoking cessation treatments. Research is needed to
develop and test innovative behavioral and combined behavioral and
pharmacological treatments that address the unique needs of these
individuals.

16\. *[Developing Behavioral Treatments for Cognitively Impaired Drug
Abusers.]{.underline}* While there are currently many efficacious
interventions available for drug addicted individuals in treatment, more
can potentially be done to enhance treatments by addressing cognitive
impairments that may accompany chronic drug use and HIV infection. Many
commonly utilized drug addiction and HIV-risk reduction interventions
assume certain basic cognitive capacities and abilities that may be
absent, or impaired, in chronic drug abusers who may also be
HIV-positive. For substance abusers to benefit from psychological
treatment, they must be capable of attending to and receiving new
information, integrating it with existing information stores, and
translating this input into more concrete behavioral change. Substance
abusers with cognitive limitations, who may not comprehend the
interventions, are more likely to drop out of treatment, relapse faster,
and have poorer long-term outcomes in comparison to cognitively intact
substance abusers. Research is needed to develop, modify, and test
"cognitive-friendly" drug dependence treatments that could lead to
improved treatment response and outcome.

17\. *[Tobacco Cessation for Pregnant and Post-Partum
Women.]{.underline}* Smoking among pregnant women remains an ongoing
public health concern. It is estimated that approximately 20-30% of
pregnant women smoke. Maternal smoking during pregnancy as been linked
to infant mortality, impaired fetal brain and nervous system
development, premature and complicated births, and low birth-weight
babies. For women who do quit during pregnancy, relapse rates vary, but
are reported as approximately 25% before delivery, 50% within four
months postpartum, and 70-90% by one year postpartum. Children of
smokers continue to be at risk for respiratory illness, middle ear
infections, impaired lung function, and Sudden Infant Death Syndrome.
Sustained tobacco cessation during pregnancy and the postpartum period
reduces health risks to both mothers and their babies. Research focused
on the development of innovative behavioral and combined behavioral and
pharmacological interventions for nicotine-addicted pregnant and
postpartum women is encouraged. Interventions may be tailored to
sub-populations of pregnant smokers, such as teenage girls, heavy
smokers, or ethnic minorities. Examples of other potential studies may
include the development of smoking cessation interventions that address
co-occurring issues, such as depression or weight-gain, interventions
that include partners or support persons, Internet-based interventions
or interventions that can be delivered by primary care physicians.

Debra Grossman, M.A.

\(301\) 443-0107

Email: <dg79a@nih.gov>

18\. *[Development of HIV Risk Reduction Interventions]{.underline}*.
Research to develop and evaluate behavioral strategies to reduce HIV
risk behaviors in HIV-positive and HIV-negative substance abusing
treatment populations. Where appropriate, risk reduction interventions
should be adapted to patients' age, gender, cultural background and
potential cognitive impairments, and should address compliance with
medical regimens. The product of such research might be training,
supervision, or educational materials, such as manuals or videotapes
that describe the intervention and its implementation by treatment
staff.

19\. *[Woman and Gender Differences in the]{.underline}* *[Provision of
Behavioral Treatments, and HIV/AIDS Risk Reduction
Approaches]{.underline}*. Develop and evaluate specific behavioral
treatment approaches targeting drug-addicted women. This may include
behavioral therapies, skills training techniques, counseling strategies,
and HIV and other infectious disease behavioral risk reduction
strategies. This may also include development and testing of training
materials that specifically address women and gender differences in drug
addiction treatment to promote effective use of research-based treatment
approaches. Training materials may involve treatment manuals, training
videos, CD ROM or DVD technologies, Internet or computer based programs
to manage aspects of treatment administration, or other innovative
educational strategies for health professionals using new technologies.

20\. *[Interventions to Improve Engagement and Retention in
Treatment.]{.underline}* Therapies designed specifically to engage and
retain individuals in treatment, especially those at high risk for HIV.
An example could be a therapy that is: (1) sensitive to the motivational
level of the client; (2) is specifically designed to respond to the
needs of the individual, whatever his or her motivational level might
be; and (3) actively works to increase an individual\'s desire to remain
in treatment.

21\. *[Complementary and Alternative Therapies (CAT) for Drug Abuse
Treatment]{.underline}*. Research is encouraged on complementary and
alternative interventions for drug abuse treatment. CAT interventions
could be the sole treatment or could be adjunctive strategies to enhance
the therapeutic potency of existing drug abuse treatments. An example of
an adjunctive CAT intervention might be where the intervention reduces
withdrawal symptoms thus enhancing retention in treatment. Included
would be interventions that are commonly used in "real world" treatment
settings, but whose therapeutic efficacy has not been scientifically
demonstrated. Such interventions include acupuncture, bioelectrical
stimulation, exercise, biofeedback, meditation, among others. The
product of this research might be a manual or video, which illustrates
the intervention and how it is implemented by treatment staff.

22\. *[Development of New or Improved Addiction Assessment Measures and
Procedures]{.underline}*. Research directed at the improvement of a
currently available measure or the design of a new psychosocial, social
or environmental measure appropriate for use in the clinical assessment
of substance abusing populations. Special consideration should be given
to a specific screening or diagnostic tool, or to a specific measure of
treatment readiness, treatment compliance, service utilization,
therapeutic process or drug treatment outcome.

23\. *[Behavioral Therapies for Pre-Adolescents and
Adolescents.]{.underline}* Behavioral therapies for pre-adolescents and
adolescents that incorporate HIV risk reduction counseling as an
integral component of the treatment. This includes the development of
new, or refinement of existing psychotherapies, behavioral therapies,
and counseling (group and/or individual). This also includes the
development and testing of manuals as well as other creative,
interactive approaches for therapy delivery that may consider different
settings for delivery, such as primary care, school-based health
programs, juvenile justice settings, etc. Also the behavioral treatments
should be culturally and gender sensitive.

24\. *[Behavioral Therapies for Couples and Families]{.underline}*. This
includes the development of new psychotherapy approaches, the
modification or testing of existing behavioral treatments, and the
design and/or testing of innovative clinical training and supervision
methods for dissemination of efficacious treatments to community
settings. Treatments that target domestic violence or other forms of
interpersonal abuse along with substance abuse are encouraged.

25\. *[Behavioral Therapies for Groups]{.underline}*. This includes the
development of new psychotherapy approaches, the modification or testing
of existing behavioral treatments, and the design and/or testing of
innovative clinical training and supervision methods for dissemination
of efficacious treatments to community settings. Examples of relevant
projects are: traditional group therapies, such as 12-step and
therapeutic community approaches, and newer group therapies such as
cognitive-behavioral and acceptance-oriented approaches; groups for
various populations, such as adolescents, adults, couple and family
groups, gender-specific groups, and groups tailored for racial or ethnic
minority populations. Of particular interest are projects that address
the recent findings suggesting possible contraindications of group
treatments for some populations (e.g., delinquent adolescents), or in
some formats (e.g., less-structured, emotion-focused group treatments).

26\. *[Behavioral Therapies Drawing from Stress Research or
Stress-Management Interventions]{.underline}*. Projects are encouraged
that apply concepts from stress research (such as appraisal, coping, and
social support) to drug abuse in innovative ways, or that test the
extent to which stress-management interventions can be applied to the
treatment of drug abuse and interventions to reduce risk of HIV and
other infectious diseases. Examples of stress-management techniques that
may have novel application to drug abuse and HIV risk include techniques
that teach problem-solving and affect-management, restore one's sense of
purpose and meaning, prevent burnout in the face of chronic stressors,
increase self-efficacy for managing stress, inoculate against stressors,
train relaxation and meditation, intervene during crises, enlist social
support and system support, and others.

27\. *[Marijuana Treatment.]{.underline}* Marijuana is the most commonly
used illicit substance in the U.S. However, relative to other drugs of
abuse, little research has focused on the treatment of marijuana
dependence. Trends in the literature suggest that the types of
treatments effective with other substances of abuse are likely to be
effective with marijuana dependence. Initial studies also suggest that
many patients do not show a positive treatment response, indicating that
marijuana dependence is not easily treated. This solicitation requests
research aimed at developing and testing effective interventions for
marijuana dependent individuals.

Melissa W. Racioppo, Ph.D.

\(301\) 443-0107, Fax: (301) 443-6814

Email: <mraciopp@nida.nih.gov>

28\. *[Transporting Behavioral Treatments to Community
Practitioners]{.underline}*. There is a need for effective methods of
transferring behavioral therapies found to be effective in clinical
trials to clinical practice. Cognitive-behavioral therapy, operant
behavioral therapy, group therapy, and family therapy are among the
therapies that have been shown to be efficacious in a highly controlled
setting and may be helpful treatment approaches in community treatment
programs as well. However, community practitioners may have been trained
using other approaches and may not have been exposed to these
scientifically based approaches. This is a call for proposals that
examine mechanisms to transfer effective research-based drug abuse
treatment information and skills-based techniques to practitioners in
the community. This may involve the development and testing of
innovative training materials and procedures to use in the training of
community practitioners to skillfully administer these treatments,
including the development of highly innovative technology transfer and
communication approaches. Research testing the transportability of
empirically supported therapies to the community is an important
component of the Behavioral Therapies Development Program.

There is also a need for the development of educational methods to train
non-drug abuse health care workers in relating to drug abusers;
eliciting medical histories regarding past or present drug abuse;
recognition of the signs and symptoms of drug abuse; identification of
those at high-risk for HIV and other drug abuse related medical problems
such as tuberculosis or hepatitis. Development and validation of a drug
abuse screening instrument which can be administered by primary health
care providers, and training in administering such an instrument is also
needed.

29\. *[Innovative Technologies for Drug Abuse Treatment, HIV Risk
Reduction, and Training Clinicians]{.underline}*. Relevant research
would be directed at the development and evaluation of innovative
technologies to treat substance abuse, enhance adherence to medications,
and/or reduce risk for HIV infection or transmission. Approaches should
be capable of being readily incorporated at reasonable cost into various
treatment settings. Areas of interest include Internet-based treatment
or training programs, CD-ROM technology, audio delivery devices, photo
therapeutic instruments, and hand-held computers. Also of interest are
creative approaches for disseminating science-based behavioral
treatments and for training therapists to use scientifically based
treatments for drug abuse and addiction. Such approaches might include
Internet-based education, interactive computer programs, telemedicine,
etc. Finally, approaches which apply therapies with evidence of efficacy
through new media such as web-based platforms, over email, or through
chat rooms and bullet boards are also desirable.

30\. *[Virtual Reality Applications for Drug Abuse Treatment Provider
Training]{.underline}*. Recently virtual reality simulations have been
used to train medical personnel in demanding medical procedures such as
microsurgery techniques. Virtual training allows trainees to gain
familiarity with both the environment in which services are delivered as
well as the intervention techniques without the danger of mistakes
impacting live patients. Virtual reality interfaces can assess skill
acquisition and provide detailed feedback during procedures to help
trainees correct mistakes or avoid making them altogether. In the drug
abuse field, training and dissemination efforts have been hampered by a
dearth of knowledge about ways to conduct dissemination. Although
trainees often practice on actual clients, this approach has drawbacks
including its reliance on the client or participant's schedule and
willingness to participate in training sessions and potential danger to
the client or if the intervention is delivered incorrectly. Libraries of
virtual reality simulations of drug users in treatment or "virtual
patients" are needed to provide experiential training for treatment
providers without relying on existing patients. This will help
facilitate the rapid and effective dissemination of proven treatment
strategies.

Development and improvement of treatments using Virtual Reality and
other new technologies is also needed. New technology may help to make
existing treatments more effective, or may make novel treatments
possible. Behavioral treatment research to develop, modify, adapt, and
test treatments for drug abuse and for comorbid psychiatric conditions
(such as anxiety disorders) using new technologies is of interest.

Cecelia Sptiznas, Ph.D.

\(301\) 443-0107, Fax: (301) 443-6814

Email: <cmcnamar@mail.nih.gov>

B. ***[Clinical Neuroscience Research.]{.underline}*** The Clinical
Neuroscience Branch (CNB) supports research on the biological etiology
(determining the biological basis for vulnerability to drug abuse and
progression to addiction, including studies on individual differences
and genetics) and clinical neurobiology of addiction (exploring
alterations of the structure and/or function of the human central
nervous system following acute or chronic exposure of drugs of abuse),
and the neurobiology of development (neurobiological effects of drugs of
abuse and addiction during various stages of development and maturation,
effects of drug exposure on neurobiological processes, development of
methodologies and refinement of techniques used in pediatric
neuroimaging). The Branch also supports investigations on the cognitive
neuroscience of drug abuse and addiction, the neurobiology of treatment,
neuroAIDS, and human pain and analgesia. Areas that may be of interest
to small businesses include, but are not limited to:

1\. *[Development of Novel Approaches in Human
Neuroscience.]{.underline}* Development of innovative, noninvasive
research methods or novel approaches are needed to identify various
neurobiological markers of brain alterations in humans induced by acute
or chronic exposure to drugs of abuse. This may include the
identification of neurobiological (including genetic) markers that might
be associated with risk for, or resilience to drug abuse and addiction.
Of particular interest are noninvasive methods (e.g., brain imaging)
that could be used to determine the effects of drug abuse/ addiction
treatments on neurobiological systems in an attempt to understand the
neurobiological processes underlying therapeutic efficacy.

In recent years, there has been an increase in studies employing
functional magnetic resonance imaging (fMRI) to understand brain
processes and functional neuronal systems. In particular, these
neuroimaging techniques are being used to probe how drugs of abuse alter
brain functioning. Consequently, there is a need for the development of
stimulus generation hardware to be used within an fMRI magnet that can
display stimuli important in drug studies. As the studies of brain
function become more sophisticated, task-related assessments of brain
activation are increasingly important. Shielded goggles or other types
of stimulus-generating hardware and software are necessary for
presentation, for example, of neurocognitive tasks, drug-related images
for the induction of craving, or other "virtual reality" types of
dynamic stimuli important in studies of drug abuse and addiction.
Responses to this type of stimulation then could be correlated with
brain measures using neuroimaging techniques. These types of studies
will provide new insights into drug-brain-behavior interactions.

Development of the human central nervous system and how drugs of abuse
perturb this process is of great interest. Little is currently known
about the effects of exposure to drugs of abuse, either prenatally or
during childhood or adolescence, on the development of the human nervous
system. Further, the application of newly emerging technologies (such as
neuroimaging) to these populations presents unique challenges due to the
fact that the central nervous system, and its capabilities, are changing
rapidly. The development of novel techniques, or the refinement of
existing methods, to provide direct noninvasive measures of brain
structure and/or function that are adapted specifically for use in
pediatric and adolescent populations is strongly encouraged. Also,
neurocognitive and other neurobehavioral tasks for use in these
populations, especially where they can be designed to probe underlying
neurobiological processes, need to be developed (for developmental
issues, contact Laurence Stanford, Ph.D.).

Steven Grant, Ph.D.

\(301\) 443-4877

Email: <sgrant@nida.nih.gov>

or

Laurence Stanford, Ph.D.

\(301\) 443-4877

Email: <lstanfor@nida.nih.gov>

2\. *[Virtual Reality for the Neurobiological Study of
Drug-Brain-Behavior Interactions and Drug Abuse Treatment.]{.underline}*
Virtual Reality (VR) is an emerging technology useful in a variety of
research-related, therapeutic and instructional settings. By immersing a
person's senses in a synthetic world or Virtual Environment (VE) that
characterizes VR, a highly flexible and programmable set of stimuli can
be used to enhance the standard approaches used in assessment of
neurobiological and neurobehavioral processes.

Collection of real-time data and bulk data recording can provide a
correlation of a stimulus reference signal with simultaneously collected
fMRI scanner and physiological data over time. Unlike most computer
access systems that accept only one or two modes of precise and/or
discrete input at a time, VR systems have the potential to monitor
movement or action from any, or many, neurobiological functions at once.
In addition, the multimodal feedback inherent in VR provides a way to
vary nonvisual stimulus components (e.g., resistance, temperature,
pitch) in a way that is impossible to achieve via standard computer
systems. Finally, VR systems provide a bypass for keyboard entry or
direct manipulation environments (e.g., pointing instruments like the
mouse), by allowing the manipulation of multi-sensory representations of
entire environments by natural actions and gestures.

VE can provide a completely controlled, noninvasive, safe and
alternative methodology for a variety of important studies of drug abuse
and addiction. For example, VR allows for the presentation of a variety
of complex, multi-sensory stimuli for neurocognitive tasks or,
alternatively, the dynamic stimuli important for producing drug-related
images for the induction of craving. VR can also be tested as an
alternative to traditional behavioral therapies in the treatment of drug
abuse. Responses obtained as a result of the above can then be
correlated with brain measures using state-of-the-art neuroimaging
techniques. We, therefore, invite studies employing VR, especially to
probe brain processes in drug abuse/addiction combined with neuroimaging
methods or to be developed or applied as a potential treatment for
substance abuse.

Ro Nemeth-Coslett, Ph.D.

\(301\) 402-1746

Email: <rn29e@nih.gov>

3\. *[Development of Interactive Computer Applications for
Neuropsychological/ Neurocognitive Assessment to Determine Functional
Brain Deficits in Acute and Chronic Drug Abusers.]{.underline}* In
addition, a neurobehavioral test battery to assess other
neurobehavioral/neurocognitive deficits resulting from drug
abuse/addiction is encouraged. Of particular interest is the development
of such assessments for use in children and adolescents exposed to drugs
of abuse to better define and understand the effects of early exposure
on brain function and development (for developmental issues, contact
Laurence Stanford, Ph.D.).

Steven Grant, Ph.D.

\(301\) 443-4877

Email: <sgrant@nida.nih.gov>

or

Laurence Stanford, Ph.D.

\(301\) 443-4877

Email: <lstanfor@nida.nih.gov>

4\. *[Development of Ligands for Brain Imaging.]{.underline}*
Development of novel radioligands for PET and SPECT imaging in human
brain for molecular targets (e.g., receptors, intracellular messengers,
disease-related proteins) is of broad interest to the neuroscience and
drug abuse research community. The primary application of these
radiotracers will be in basic neuroimaging research. Ultimately, these
radiotracers may also be used as potential biological markers and
surrogate endpoints for translational and clinical research, drug
discovery and development, and clinical trials. The scope of the
projects may encompass pilot or clinical feasibility evaluation in
pre-clinical studies, model development, or clinical studies.
Alternatively, the focus may be on research and development of new
technologies for radiotracer development.

Steven Grant, Ph.D.

\(301\) 443-4877

Email: <sgrant@nida.nih.gov>

5\. *[Novel Approaches in the Clinical Neurobiology of Drug
Addiction.]{.underline}* Many scientists involved in behavioral and
neurobiological research are faced with growing difficulties in
identifying approaches, devices (e.g., research tools) and/or strategies
to broaden the within-discipline knowledge base for understanding,
preventing and treating drug abuse. NIDA has a strong interest in
facilitating the identification and use of cross-disciplinary research
tools and materials that are being used and have proven efficacious in
research unrelated to drug abuse (e.g., virtual reality, transcranial
magnetic stimulation, deep brain stimulation). NIDA also has a strong
interest in promoting the commercial adaptation and widespread
availability of discoveries ("tools") made in the course of
interdisciplinary research to better serve its mission.

The term research "tool\" is being used in its broadest sense to embrace
the full range of resources that scientists use in the laboratory and
clinicians use as therapeutics; therefore, one investigator's tool may
be another\'s end product. The value of research tools is difficult to
assess and varies greatly from one tool to the next and from one
situation to the next. Providers and users are likely to differ in their
assessments of the value of research tools. Many research and clinical
tools are costly to develop and have significant competitive value to
the firms that own them.

Advances in biomedical science continuously yield new research findings
that play a critical role in the furtherance of knowledge and innovation
in both the public and private sectors. For the purpose of this
solicitation, the term research tool may include methods, laboratory
equipment and machines, databases and computer hardware and software.
From a clinical perspective, interactive games and emerging game
technologies are being used successfully in a variety of health
education situations; therefore, applications proposing introducing
these "tools" as adjuncts in the prevention and treatment of drug abuse
will be accepted. NIDA has solicited and continues to solicit proposals
using virtual reality to increase our understanding of the neurobiology
of addiction, (e.g., drug cues, craving), comorbidity (e.g.,
post-traumatic stress disorders) and pain (e.g., distraction).
Additional novel approaches, devices and strategies are now being sought
to further our understanding of the cognitive neuroscience of drug abuse
and addiction, neuroplasticity and repair, the neurobiology of treatment
(including training tools, assessment and neurolobiologic correlates of
treatment outcome) and neuroAIDS.

Ro Nemeth-Coslett, Ph.D.

\(301\) 402-1746

Email: <rn29e@nih.gov>

6\. *[Development of Serious Games for Neuro-Rehabilitation of
Drug-Induced Cognitive Deficiencies.]{.underline}* Health-related gaming
is an emerging industry useful in a variety of research-related,
therapeutic and instructional settings. Serious games can provide a
completely controlled, noninvasive, safe and alternative methodology for
a variety of important studies of drug abuse and addiction.

By involving a person in an interactive computerized situation, designed
to be both entertaining yet directive (i.e., in the sense of covertly
shaping desired behaviors via highly flexible and programmable sets of
scenarios), altered behaviors can be introduced by pre-programming
consequences to counteract and potentially reset undesirable
neurobiological and neurobehavioral deficits associated with chronic
drug abuse.

It is hypothesized that changes in behavioral contingencies as a
consequence of varying time and/or rate of the
stimulus-response-reinforcer sequence (e.g., designing a game that
involves differential rates for low responding (DRL) schedule) may alter
brain activity (pattern changes noted using state-of-the-art
neuroimaging techniques) and, thus, correlate with the improvement of
neurocognitive deficits

Neurocognitive deficits are generally drug-specific. For example,
chronic methamphetamine abusers loose their decision-making ability, and
suffer attentional bias in a visual discrimination task. Cocaine abusers
lack cognitive flexibility, the ability to use feedback to
monitor/change behavior, have slower reaction times on match-to-sample
and increased errors (both omission and commission) along with
attention/concentration deficits. Chronic use of opiates produces an
increase in auditory, visual, and associative reaction times, impaired
vigilance, attention, information processing, short-term visual memory,
delayed visual memory, short-term verbal memory, long-term verbal memory
and problem solving. Although in controversy, marijuana may decrease
one's ability to focus, sustain, and shift attention as well as decrease
memory and motivation.

Ro Nemeth-Coslett, Ph.D.

\(301\) 402-1746

Email: <rn29e@nih.gov>

C. ***[Human Development Research.]{.underline}*** The Behavioral and
Brain Development Branch (BBDB) supports a broad research, research
training and career development programs directed toward: (1) an
increased understanding of how developmental processes and developmental
outcomes are affected by drug exposure and related factors; (2) an
increased understanding of developmental processes that are relevant to:
(a) drug use, abuse, addiction, treatment and relapse, and (b) risk
behaviors related to drug abuse and other health conditions that often
accompany drug use (*e.g.,* HIV infection, STDs); (3) the use of
translational approaches to increase understanding of these
developmental processes; and (4) an increase in effective interventions
aimed at preventing or ameliorating negative developmental outcomes
resulting from exposure to drugs and related factors.

1\. *[Develop Improved Technology for Assessment of Prenatal Drug
Exposure and Passive Postnatal Drug Exposure.]{.underline}*

a\. Develop and refine methods for the detection and quantification of
infant exposure to drugs of abuse during pregnancy, including cocaine,
marijuana, opiates, and methamphetamines.

b\. Develop and refine methods for the detection and quantification of
passive exposure to illicit drugs during infancy and childhood.

Vincent Smeriglio, Ph.D.

\(301\) 443-4877

Email: <vsmerigl@nida.nih.gov>

2\. *[Develop Interactive Database Systems on Human Subjects Issues for
Use by Drug Abuse Researchers Studying School-Age Children and
Adolescents Drug Use.]{.underline}* Develop systems to assist
investigators in obtaining technical and legal information relevant to
involvement of children and adolescents in research on drug abuse.
Examples of pertinent situations include tracking long-term health and
development of children exposed to drugs during pregnancy, and
investigating vulnerability and possible pathways to drug abuse among
school-age children and adolescents. These database systems should
address issues such as assent and consent, should provide information on
variation in laws and guidelines across jurisdictions, should include
the capacity for interactive communication on numerous situations
potentially facing investigators, and should serve as sources of
referral for additional assistance.

Vincent Smeriglio, Ph.D.

\(301\) 443-4877

Email: <vsmerigl@nida.nih.gov>

3\. *[Develop Improved Methods of Neuroimaging to Assess Structural and
Functional Status of the Brains of Children and Adolescents Exposed to
Drugs.]{.underline}* Document the feasibility and accuracy of
appropriate and acceptable methods for assessing brain structure and
function of children and adolescents, with special attention to any or
all of the following groups: those exposed to drugs during pregnancy,
those passively exposed during infancy and childhood, and those actively
using illicit substances. Documentation should include attention to such
matters as technological difficulties and risks, and standardization
issues relevant to testing conditions and image analysis.

Larry Stanford, Ph.D.

\(301\) 443-4877

Email: <lstanfor@nida.nih.gov>

4\. *[Develop and Refine Methodologies for Drug Use Measurement Among
Adolescents.]{.underline}* Research to develop and refine methodologies
for drug use detection and quantification, with special application to
the adolescent with HIV infection or at high-risk for HIV infection.
This research should address issues of acceptability, reliability, and
validity of one or more methods (e.g., interviews, computerized
questionnaires, and biological indicators such as saliva or sweat).

Nicolette Borek, Ph.D.

\(301\) 443-4877

Email: [nborek@nida.nih.gov](mailto:nborek@nida.gov)

[]{#__RefHeading___Toc124236926 .anchor}Division of Basic Neuroscience
and Behavioral Research (DBNBR)

DBNBR's basic neuroscience and behavioral research focuses on
understanding the mechanisms, characteristics, and processes of drug
abuse. Basic behavioral, cognitive, neurobiological, cellular,
molecular, chemical, and genetics research aims at characterizing and
understanding drug seeking, compulsive behavior, and addictive
processes. These research areas necessarily include studies of normal
processes.

Using both animal and human studies, basic behavioral research focuses
on behavioral and cognitive processes that may or do lead to drug
initiation, and the behavioral and cognitive consequences of drug abuse.
Neurobiology research focuses on the neural mechanisms and substrates
underlying behavioral and cognitive processes and vulnerability factors
associated with drug abuse, addiction, sensitization, tolerance, and
relapse. DBNBR supports basic chemistry and pharmacological studies
focusing on structure/activity relationships, definition, and
characterization of systems involved in drug actions, chemical synthesis
of new ligands, pharmacokinetics, analytical methods, understanding
basic mechanisms of drug action and drug testing.

Computational and theoretical modeling of biological systems and
behavioral processes, biomedical computing and/or information science
and technology development is supported by DBNBR.

1\. *[Nanoscience-based Design of Therapies for Substance Abuse
Treatment.]{.underline}* Nanoscience and nanotechnology, by manipulating
matter at the atomic or molecular levels, are emerging research areas
that have the potential to fundamentally transform the study of
biological systems and lead to the development of new methods for
detection, prevention, and treatment of substance abuse and related
disease states. NIDA invites nanotechnology-based applications in the
following areas:

a\. Methods to enhance the efficacy of FDA-approved compounds by
reducing their size to the nanoscale range to alter absorption,
distribution, metabolism, or excretion.

b\. Development of new compounds, through manipulation of matter at the
atomic or molecular levels that could more readily pass the
blood-brain-barrier or cell membranes.

c\. Development of nanoscale particles for controlled targeted delivery
of therapeutics, genes, or antibodies.

d\. Methods to enhance existing imaging technologies using magnetic
properties at the nanoscale.

e\. Application of nanostructures (e.g. noble metal nanoparticles,
quantum dots, and nanolithographic structures that show promise for
diagnostic development) for identification and analysis of genes,
proteins, and other biological molecules implicated in the actions of
drugs of abuse.

Proposals are invited from any of the above areas. Phase I should
demonstrate convincingly the viability of the proposed innovation,
whereas Phase II should carry out the development, characterization,
testing, and screening of the innovation.

Thomas G. Aigner, Ph.D.

\(301\) 443-6975

Email: <ta17r@nih.gov>

2\. *[Virtual Reality for Treatment of Pain.]{.underline}* Recent
findings (Hoffman et al., 2000, Pain, 85, 305-309) have suggested that
Virtual Reality (VR) exposure can reduce reported pain during wound
care. Grant proposals are sought to examine the utility of VR
technologies in the treatment of various types of pain. Development of
treatments for both acute and chronic pain is sought. These treatments
can be based in clinical settings or the patients' homes. Phase I
testing should establish the feasibility of the use of this technology
in the particular population to be tested. Phase I should also produce
data that demonstrates that this methodology is effective for the
particular type of pain being treated. Phase II should involve
larger-scale testing (e.g., more subjects and treatment trials)
examining various treatment parameters (e.g., timing of treatment, types
of VR environments). The focus of Phase II testing should be the
refinement of this treatment for use in pain patients.

3\. *[Virtual Reality for the Treatment of Drug Abuse.]{.underline}*
Recent findings (Hoffman et al., 2000, Pain, 85, 305-309) have suggested
that Virtual Reality (VR) can be a useful clinical tool. In this
particular study, VR exposure was used to allow patients to selectively
not attend to an otherwise painful procedure. Drug abuse, like pain, is
a problem that is strongly impacted by stimuli in the abuser's
environment and psychological factors. Thus, it is reasonable to assume
that VR may be useful in allowing individuals to ignore drugs cravings,
withdrawal symptoms or environmental cues that promote drug abuse. Grant
proposals are sought to examine the utility of VR technologies in the
treatment of various types of drug abuse. These treatments can be based
in clinical settings or the patients\' homes. These treatments can be
developed to address drug withdrawal, drug craving or on-going drug
related behaviors. The development of VR technologies to address abuse
of all types of drugs (e.g., cocaine, marijuana, nicotine, alcohol,
inhalants) are sought. Phase I testing should establish the feasibility
of the use of this technology for the particular drug problem addressed
(e.g., cocaine craving, opioid withdrawal) and should also produce data
that demonstrates that this methodology is effective for the particular
drug problem. Phase II should involve larger-scale testing (e.g., more
subjects and treatment trials) examining various treatment parameters
(e.g., timing of treatment, types of VR environments). The focus of
Phase II testing should be the refinement of this treatment for use in
the treatment of drug abusers.

David Thomas, Ph.D.

301-443-6975

Email: <dt78k@nih.gov>

4\. *[Development of a Virtual Reality Environment for Teaching about
the Impact of Drug Abuse on the Brain.]{.underline}* Virtual reality
(VR) is emerging as a technology with a multitude of uses within the
medical sciences. In terms of the science of drug abuse, it is being
developed as a treatment tool. The current solicitation seeks the
development of a virtual reality environment that can be used in
educational settings to teach about how drugs of abuse (both illicit and
licit) affect the brain and behavior.

The cost of portable hardware needed to present a VR environment is
relatively inexpensive. If education programs like the one sought in
this solicitation were available, it is likely that VR would be used as
a teaching tool in many settings, including classrooms and museums.

The particular program sought here is to present an interactive
three-dimensional virtual brain that shows normal brain functions and,
in contrast, brain function after exposure to drugs of abuse. This
technology could illustrate the neurotoxic and long-term effects of drug
abuse on the brain. This VR may include other features that are not
described above, provided that it will be useful in educating
individuals about the medical, behavioral and social effects of drug
abuse.

The phase I proposal should develop a beta version of the program.
Further, the phase I application should include a preliminary
demonstration of "usability," where it is shown that the types of people
being educated with this program (e.g. teachers) can effectively operate
this system without extensive training. Further, it should be
demonstrated that the hardware is easily worn by subjects, and that the
subjects can rapidly understand how to effectively interact in the VR
environment.

David Thomas, Ph.D.

301-443-6975

Email: <dt78k@nih.gov>

5\. *[Chemical Libraries for Drug Development.]{.underline}* The
development and biological screening of lead compounds and their
combinatorial libraries for use in the area of drug abuse treatment
research are encouraged, such as generation of new ligands having opiate
receptor selectivity, or ligands with NMDA or serotonergic
agonist/antagonist activity and/or related ligands. These would be
designed as lead compounds either for drug design or as tools to
elucidate mechanisms of action of drug abuse.

Hari H. Singh, Ph.D.

\(301\) 443-1310

Email: <hs87j@nih.gov>

6\. *[Genetic Studies.]{.underline}* The National Institute on Drug
Abuse is interested in SBIR proposals that would facilitate the
identification of genetic loci that confer vulnerability to substance
abuse and addiction. Areas of interest include but are not limited to:

a\. Collection and genotyping of human pedigrees and sib-pairs for
vulnerability or resistance to drug abuse.

b\. Isolation and identification of mutant strains in genetic model
systems such as Zebra fish, Drosophila, C. elegans, mice, and rats that
are more vulnerable or resistant to drugs of abuse.

c\. Design, development, and marketing of behavioral apparatuses to
conduct rapid behavioral throughput screens for identifying genetic
vulnerability to addiction in genetic model systems.

d\. Development of transgenic models for drug abuse using bacterial
artificial or yeast artificial chromosomes.

e\. Development of software and databases for candidate genes for drug
abuse.

f\. Identification and mapping of functional polymorphisms of candidate
genes for drug abuse.

g\. Placement of candidate genes for drug abuse on biochips.

h\. Marker-assisted breeding of congenic mouse and rat strains for
mapping quantitative trait loci associated with addiction and drug
abuse.

i\. Vectors for gene transfer into neurons.

Jonathan Pollock, Ph.D.

\(301\) 443-6300

Email: <jp183r@nih.gov>

7\. *[Drug Testing Development.]{.underline}* Development of new, more
refined or more practical drug testing methodologies. Studies may focus,
but are not limited to the following topics: drug testing methods; drug
extraction procedures; methods to control for possible environmental
contamination factors; and reference materials. Methodologies with
special application to the workplace, the emergency room, the
transportation environment, or other specific settings are welcome.
Methodologies with an emphasis upon circumstances for testing such as
post-accident testing or readiness for work testing are also encouraged.

Hari H. Singh, Ph.D.

\(301\) 443-1310

Email: <hs87j@nih.gov>

8\. *[Effects of Drugs at the Cellular Level.]{.underline}* Development
of new imaging techniques, reagents and related hardware and software
for dynamic investigations of the effects of drugs of abuse on cellular
activities and communications. For example, these techniques might
include, but are not limited to, development and utilization of reagents
for magnetic resonance microscopy and other MRI methods; development of
methodologies applying functional MRI to drug abuse studies; the use of
dyes, intrinsic signals, and other optical indicators for studying
signal transduction mechanisms, the regulatory control of protein
entities (such as phosphorylation), and neuronal excitatory and
inhibitory pathways. Areas of interest may include, but are not limited
to:

a\. Studies using molecular biological techniques to scale-up protein
production for investigations aimed at enhancing understanding of the
structure, function and regulation of molecular entities involved in the
cellular mechanisms through which abused drugs act.

b\. Validated in vitro test systems can reduce the use of animals in
screening new compounds that may be of potential benefit in treating
drug abuse. Test systems are needed to evaluate activity at receptors or
other sites of action, explore mechanism(s) of action, and assess
potential toxicity.

c\. With the recent success in molecular cloning of various drug abuse
relevant receptors, enzymes, and other proteins, researchers will
elucidate the molecular mechanism of action of these drugs. Studies to
generate strains of transgenic animals carrying a gene of interest are
solicited. Of special interest are knockout and tissue-specific knockout
animals. These animals can be used to identify gene function, and to
study the pharmacological, physiological, and behavioral role of a
single gene.

Jonathan Pollock, Ph.D.

\(301\) 443-6300

Email: <jp183r@nih.gov>

9\. *[Toxicity Studies]{.underline}*

a\. Studies on abused drugs and their metabolites to develop
methodologies that may be potentially useful in addressing medical
emergencies. Such studies might include investigations involving
development of pharmacokinetic models, methodologies, and data.

b\. Concern remains about the potential acute and chronic neurotoxicity
of drugs of abuse. Information is needed about the possible
neurotoxicity of pharmacotherapeutic agents with potential for treating
drug abuse. Improved methods are needed for identifying, assessing, and
quantifying the nature and extent of neurotoxicity. Such studies might
include the development or application of quantitative chemical,
physiological, or behavioral measurements relating to nervous system
injury or methods for quantitative analysis of damage.

Pushpa V. Thadani, Ph.D.

\(301\) 443-6300

Email: <pt24e@nih.gov>

10\. *[Predisposition to Cardiovascular Complications Associated with
Abused Substance(s).]{.underline}* Development of experimental animal
models to assess a genetic predisposition or increased sensitivity to
cardiac and vascular complications associated with drug use. Such
studies might include, but are not limited to, investigations involved
with biochemical, physiological and pathological indices of
cardiovascular system function.

Pushpa V. Thadani, Ph.D.

\(301\) 443-6300

Email: <pt24e@nih.gov>

11\. *[Opioid Peptides.]{.underline}* Research and development directed
at the medicinal chemistry and molecular pharmacology of opioid
peptides, especially in methods development. Areas of interest include
but are not limited to:

a\. Development of innovative methodologies for the synthesis of opioid
peptides to be made available to researchers. Syntheses proposed should
be limited to single analogs.

b\. Methods to identify new ligands for opioid receptors and the design
of new opioid peptide analogs with therapeutic potential.

c\. Development of analytical methodologies for the quantitation of
synthetic and endogenous opioid peptides, peptide precursors, and
processing enzymes. The innovation may be limited to a part of the
method, such as development of a special detector or a sample cell.
Methods might include antibody development and development of innovative
immunoassays.

12\. *[Ligands for receptors of drugs of abuse.]{.underline}*
Applications are solicited using chemical combinatorial library
techniques or traditional synthetic methods, to develop ligands having a
high degree of efficacy and selectivity, antagonists, partial agonists,
inverse agonists, neutral agonists to receptors of drugs of abuse such
as for dopamine and serotonin receptors, DA and 5-HT, NE transporters,
nicotine receptors, cannabinoid receptors, excitatory amino acid
receptors, m-Glu receptors, opioid receptors, GHB receptors and others.
These can be useful both as pharmacological tools and lead compounds in
medicinal chemistry/drug development.

Rao Rapaka, Ph.D.

\(301\) 443-6300

Email: <rr82u@nih.gov>

13\. *[Cellular Systems Biology.]{.underline}* The National Institute on
Drug Abuse is interested in SBIR proposals that would facilitate global
analysis of biological systems relevant to drug abuse. Technologies and
resources developed should be applicable and relevant to drug abuse
research. Areas of interest include, but are not limited to:

a\. Improved technology for analysis of membrane proteomes for the
identification of targets and validation of leads.

b\. Development of technology or new strategies that will improve
dynamic range to allow the analysis of a broader spectrum of the
proteome of neural cells.

c\. Single cell analysis and the development of model systems for
proteomic analysis of neuronal function and drug effects.

d\. Development of real-time proteomics technology for the analysis of
processes such as cellular responses to drug exposure.

e\. High throughput, high resolution 3‑dimensional in situ proteome
profiling such as optical projection tomography, improved methods for
high throughput sectioning of neural tissue and the development of tools
for identifying and mapping protein expression, localization and
movement relevant to addiction and other medical consequences of drug
abuse.

f\. High throughput, functional, molecular interaction screening methods
for proteins implicated in drug abuse.

g\. Strategies to characterize post-translational modifications related
to addiction and drug effects.

h\. Development of proteomic tools for identifying biomarkers to track
therapeutic efficacy, to monitor effects of drug interactions, and to
advance biological understanding of relationships between drug use and
infectious disease, and therapies for HIV, hepatitis C and other
diseases.

i\. Technologies to identify parameters of molecular, cellular, or
physiological systems important in addiction, and the properties of the
system, such as redundancy and robustness.

j\. New approaches for characterizing cell phenotypes and mapping those
phenotypes.

k\. Development of other novel technologies using non-mammalian animal
model systems or new approaches for sensing and analyzing cell
components and activities (such as quantum dots).

Karen Skinner, Ph.D.

\(301\) 443-6300

Email: <Ks79x@nih.gov>

or

Christine Colvis, Ph.D.

\(301\) 443-6300

Email: <ccolvis@nida.nih.gov>

14\. *[Research Resources.]{.underline}* The National Institute on Drug
Abuse is interested in SBIR proposals that would generate the following
resources for drug abuse research:

a\. Resources for the application of genetic engineering to dynamically
monitor neuronal function.

b\. C57BL6 Mouse embryonic stem cells and spermatogonial stem cells.

c\. Turnkey technology for proteomics such as the development of protein
and peptide chips to study drug effects on neuronal mechanisms.

d\. Antibodies, aptamers, ligands, etc. relevant to drug abuse research.

Jonathan Pollock, Ph.D.

\(301\) 443-6300

Email: <jp183r@nih.gov>

15\. *[Development of Innovative Synthetic Probes, Drug Dosage Forms,
and/or Drug Metabolites For Drug Abuse Research.]{.underline}* Proposals
are solicited for the synthesis of new chemical compounds, drug
metabolites, peptidomimetics, and/or development of drug dosage forms
for studying the mechanism of action of drugs of abuse and drug
addiction.

Specifically proposals are encouraged in the following areas:

a\. Synthesis of chemical probes, drug metabolites, peptidomimetics,
and/or development of drug dosage forms that are needed by drug abuse
research investigators and not commercially available, or difficult to
obtain.

b\. Alternate synthetic methods for existing chemical probes that
improve the yield and produce these chemicals at lower costs as compared
to commercially available substances.

c\. Development of alternate drug dosage forms of existing drugs/drug
products for enhancing their efficacy.

Hari H. Singh, Ph.D.

Phone: (301) 443-1310

Email: <hs87j@nih.gov>

16\. *[Development of Analytical Techniques.]{.underline}* The
development of new analytical methods for measuring drugs of abuse and
their metabolites in biological matrices, such as urine, blood, saliva,
sweat, hair, breast milk, brain tissue, and meconium is encouraged. The
new methods should be efficient, sensitive, convenient, and cost
effective. Modifications and improvements in existing analytical
techniques are also encouraged particularly those improving sensitivity
and selectivity.

Hari H. Singh, Ph.D.

Phone: (301) 443-1310

Email: <hs87j@nih.gov>

17\. *[Metabolomics in Drug Abuse Research.]{.underline}* Metabolomics
is the study of all the molecules of a cell or organism and their
identification and quantification that helps to understand the cellular
regulation, metabolic pathways and activity and response under normal
and other conditions. This technique thus could be used to develop
metabolic profiling of normal or healthy subjects and subjects under the
influence of substances of abuse or those undergoing drug
rehabilitation. NIDA is seeking proposals to develop metabolomic
profiling of subjects under the influence of drugs of abuse to identify
and characterize biomarkers for understanding the addictive disorder.
Proposals using animal and/or human model studies are welcomed. Phase I
proposals should demonstrate the feasibility of metabolic profiling and
phase II should focus on the application of this invention in
identifying and characterizing responsible biomarkers.

Hari H. Singh, Ph.D.

Phone: 301-443-1310

E-mail: <hs87j@nih.gov>

18\. *[Computation, modeling and data integration in Drug Abuse
Research.]{.underline}*

a\. Development of software or other tools, which enable data
integration, and the development of computational models related to
addiction and other medical consequences of substance abuse, e.g. tools
that enable the integration of proteomics, genomics, transcriptomics,
metabolomics and other data into applications leading to systems
understanding of drug effects upon biological systems, or developing
innovative approaches for managing knowledge and integrating information
from text, data, image, and other sources or files generated in
addiction research.

b\. Tools that enable multilevel and multiscale modeling of biological
and behavioral systems relevant to substance abuse research, such as
those relevant to evaluations of expected utility.

c\. Development of software tools and interactive technologies (such as
applications of grid technologies and networked appliances) which enable
the prevention, study, and treatment of substance abuse as well as the
evaluation of prevention and treatment strategies.

Karen Skinner, Ph.D.

\(301\) 435-0886

Email: <Ks79x@nih.gov>

19\. *[Tools and Resources for Epigenetics Research.]{.underline}*

Some of the long-term effects that occur in addiction may be attributed
to epigenetic changes. As researchers begin to investigate these changes
as a mechanism leading to addiction, several tools and resources would
be needed. Phase I should demonstrate feasibility of the approach. Phase
II is for production of the resource.

a\. Development of a new battery of HDAC isoform-selective inhibitors
that cross the blood-brain barrier.

b\. Transgenic mice containing knock-in tandem affinity tags (which
would allow definition of transcription factor binding sites for any
factors of interest).

c\. Methods for determining the subcellular localization of microRNAs.

d\. Technical innovations to allow genome-wide screening for changes in
DNA methylation.

e\. Development of antibodies to chromatin regulatory proteins.

f\. Creation of tools to allow unambiguous labeling of a specific amino
acid on a specific histone in a specific gene region.

Christine Colvis, Ph.D.

301-435-1323

Email: <ccolvis@nida.nih.gov>

or

Joni Rutter, Ph.D.

301-435-0298

Email: <jrutter@nida.nih.gov>

[]{#__RefHeading___Toc124236927 .anchor}Division of Epidemiology,
Services and Prevention Research (DESPR)

A. ***[Prevention Research Branch (PRB).]{.underline}*** The Prevention
Research Branch (PRB) supports a program of research in drug abuse and
drug related HIV prevention to (1) examine the efficacy and
effectiveness of new and innovative theory-based prevention approaches
for drug abuse, drug-related HIV/AIDS and other associated health risks,
(2) determine the cognitive, social, emotional, biological and
behavioral processes that account for effectiveness of approaches, (3)
clarify factors related to the effective and efficient provision of
prevention services, and (4) develop and test methodologies appropriate
for studying these complex aspects of prevention science.

*[Prevention Research]{.underline}*. Rigorous scientific prevention
research is encouraged to study novel approaches to substance abuse
prevention for use at multiple levels of the social environment
including: the family, schools, peer groups, community and faith-based
organizations, the workplace, health care systems, etc. The purpose of
this research is to determine the efficacy and effectiveness of novel
program materials, training strategies, and technologies developed to
prevent the onset and progression of drug abuse and drug-related
HIV/AIDS infection. Materials and technologies may target a single
risk-level or may take a comprehensive approach encompassing audiences
at the universal, selective, and/or indicated levels. Universal
interventions target the general population; selective target subgroups
of the population with defined risk factors for substance abuse;
indicated interventions target individuals who have detectable signs or
symptoms foreshadowing drug abuse and addiction, but who have not met
diagnostic criteria. NIDA encourages the development and testing of
innovative prevention intervention technologies that are sensitive and
relevant to cultural and gender differences.

1\. Laboratory studies of the underlying mechanisms and effects of
various prevention approaches such as persuasive communication (e.g.,
mass media and print media) as they are affected by and affect drug
related cognition, emotion, motivation and behaviors.

2\. Decomposition of prevention programs to understand components that
account for program effectiveness.

3\. Research on features of prevention curricula, materials,
implementation, approaches, training, technical assistance, and systems
integration that contribute to positive outcomes.

4\. Training modules and ongoing technical assistance for program
implementers of research based substance abuse prevention programming
strategies.

5\. Prevention intervention dissemination technologies and mechanisms
that integrate research with practice; specifically the transfer of drug
abuse prevention information to decision-makers, funders, and
practitioners.

6\. Prevention services research on the organization, financing,
management, delivery, and utilization of drug abuse prevention programs.

7\. Strategies for the integration of proven prevention approaches into
existing service delivery systems.

8\. Studies that develop and assess reliability and validity of
developmentally appropriate self-report, physiological, and biochemical
measures for use in prevention trials in a variety of settings and a
variety of audiences.

9\. Development of and testing of environmental change strategies for
schools, neighborhoods, communities, etc. to use in reducing substance
use initiation and/or progression.

10\. Development of community needs assessment tools and services.

11\. Drug abuse prevention methodological research on promising data
collection, data storage, data dissemination, and reporting techniques.

Larry A. Seitz, Ph.D.

\(301\) 402-1725

Email: <ls75t@nih.gov>

B. ***[Epidemiology Research Branch (ERB).]{.underline}*** The ERB
supports a research program on drug abuse epidemiology that includes (1)
studies of trends and patterns of drug abuse and related conditions such
as HIV/AIDS in the general population and among subpopulations, (2)
studies of causal mechanisms leading to onset, escalation, maintenance,
and cessation of drug abuse across stages of human development, (3)
studies of person--environment interactions, (4) studies of behavioral
and social consequences of drug abuse, (5) bio-epidemiologic studies
including genetic epidemiology studies, (6) methodological studies to
improve the design of epidemiologic studies and to develop innovative
statistical approaches, including modeling techniques.

1\. *[Improvement of Reliability and Validity of Reporting of Sensitive
Data]{.underline}*. The reliability and validity of self-report of drug
use and related behaviors (e.g., HIV risk behavior) is a matter of great
concern. Use of new technologies for real time data collection in
ecological settings is of great interest because these technologies
enable collection of drug consumption data in context. Studies to
improve methodologies based on variations of standard survey protocols
or computer-assisted self-interview (CASI) and personal interview (CAPI)
are also encouraged.

2\. *[Instrument Development.]{.underline}* Easy-to-use assessment
instruments are needed to enhance epidemiology research. Areas of
interest include but are not limited to:

a\. *[Community Assessment.]{.underline}* The development of community
diagnostic instruments for psychometrically sound assessment of
community characteristics is essential to improve our understanding of
how community factors affect drug abuse and ensuing behavioral and
social consequences. Standardized assessments of community
characteristics are needed to better understand the full impact of drug
use and to develop targeted interventions to specific community needs.

b\. *[Assessment of Psychiatric Comorbidity in Community
Settings.]{.underline}* Easy to use, reliable, and valid instruments are
needed to assess psychiatric comorbidity in different populations of
drug abusers, including adolescents and those in community drug abuse
treatment settings.

c\. *[Assessment Instruments to Measure CNS Function Related to Drug
Abuse.]{.underline}* The development of age-appropriate assessment
instruments to measure behavioral and cognitive function over the course
of development will contribute to our understanding of vulnerability to
drug abuse and functional impairment due to drug use.

Douglas Rugh, Ph.D.

\(301\) 402-1935

Email: <drewgh@nida.nih.gov>

C. ***[Services Research Branch (SRB).]{.underline}*** The SRB supports
a program of research on the effectiveness of drug abuse treatment with
a focus on the quality, cost, access to, and cost-effectiveness of care
for drug abuse dependence disorders. Primary research foci include: (a)
the effectiveness and cost-benefits and cost-effectiveness of drug abuse
treatment, (b) factors affecting treatment access, utilization, and
health and behavioral outcomes for defined populations, (c) the effects
of organization, financing, and management of services on treatment
outcomes, (d) drug abuse service delivery systems and models, such as
continuity of care, stages of change, or service linkage and integration
models, and (e) drug abuse treatment services for HIV seropositive
patients and for those at risk of infection.

1\. *[Drug Abuse Treatment Economic Research]{.underline}*. This
initiative will support research to design and develop data systems for
financial management and economic analysis of treatment programs and
larger systems in new healthcare settings and managed care networks.
Managerial decision-making requires the implementation of sophisticated
data systems to facilitate routine budgeting processes, allocation of
resources, performance measurement, and pricing decisions. The focus is
on the needs of managers within the organization and managers outside of
the organization. Data system development must be based on standard cost
behavior and profit analysis. Data systems must be designed with correct
cost concepts (accounting and economic) in order to permit cost and
pricing decisions to be developed for new treatment technologies and
management of on going systems. In research settings, such an initiative
is vital for the assessment of new technologies developed for transfer
to practice.

William S. Cartwright, Ph.D.

\(301\) 443-6504

Email: <wc34b@nih.gov>

2\. *[Personnel Selection Technology Research for Drug Abuse Treatment
Clinics]{.underline}*. Research is showing that employee turnover is a
substantial problem among substance abuse treatment services providers.
Applications supporting innovative research that develops and validates
generic staff selection systems which could be adopted and tailored for
use by drug abuse treatment clinics are welcome. Like many small
businesses, drug abuse treatment clinics have problems attracting and
retaining qualified personnel. Also like many small businesses,
treatment clinics have limited resources to apply to the recruiting,
screening, and hiring of new and replacement personnel. Research has
shown that the application of standardized screening and selection
methods designed to maximize person-job fit can cost-effectively reduce
staff turnover. Systematic methods such as background inventories,
protocol-driven interviews, aptitude tests, and credit checks have
demonstrated validity for improving person-job fit. Examples of possible
projects might include development of easy-to-understand guidance about
legal considerations in hiring practices, software that transform job
task analysis into selection criteria, interview protocols to
standardize applicant screening, tolls to help improve recruitment,
and/or self-paced training for hiring officials or interview panels to
improve screening reliability.

3\. *[Customer Retention Technology]{.underline}*. Premature
disengagement from drug abuse treatment participation is a common
problem and ranges from approximately 30 to 60% based upon the clinic
and modality studied. Past research has very frequently attributed
dropping out of treatment to participant characteristics (e.g.,
motivation, addiction severity, comorbidity) and/or environmental
factors (e.g., social pressures, unemployment, homelessness). Seldom has
the dropout problem been studied in the context of customer
satisfaction. That is, there is little research looking at the causes of
dropping out of treatment attributable to organizational factors (e.g.,
policies, practices, context) that influence participant withdrawal
decisions. Needed are tools and systems for assessing and surveying drug
abuse treatment program participant perceptions and satisfaction levels,
summarizing and report participant assessments, interpreting results,
and adjusting policies and practices to improve satisfaction and
participant retention in treatment.

4\. *[Effective Management and Operation of Drug Abuse Treatment
Services Delivery]{.underline}*. The bulk of drug abuse treatment is
conducted in small clinical settings with therapeutic staffs of less
than a dozen people. Small clinics lack resources to help improve
efficiency and effectiveness in both business and therapeutic practices.
Areas that may be of interest to small businesses include, but are not
limited to:

a\. Computer-based leader/manager self assessment tools: On-line and
other types of tools to help those supervising the delivery of drug
abuse treatment services to gain insights about personal strengths and
weaknesses, and to help guide them to improved leadership and management
practices.

b\. Organizational change tools: Handbooks describing step-by-step way
to introduce more efficient business practices such as quality
management/monitoring, creating empowered work teams, formalized goal
setting, improved customer relations, forming organization linkages, and
adopting new fiscal and resource management techniques.

c\. Organizational change tools: Handbooks describing step-by-step ways
to introduce more efficient or effective therapeutic practices such as,
adding pharmacotherapy in a previously drug-free clinic, adopting new
medical/pharmacotherapy or behavioral interventions, and adopting new
approaches to clinical collaboration and/or case management.

Thomas F. Hilton, Ph.D.

\(301\) 443-6504

Email: <Tom.Hilton@nih.gov>

5\. *[Web-Based Technologies: Transporting Services Research to
Practice]{.underline}*. This initiative will support the development and
testing of the effectiveness of web-based technologies that facilitate
the translation of drug abuse prevention and treatment services research
into practice. The ultimate goal is the delivery of efficacious,
low-cost interventions to the greatest number of individuals in
community settings. Delivery of evidence-based services in community
settings often is hampered by lack of state-of-the-art information about
the contents of efficacious interventions, the organizational structures
and processes that make effective implementation possible, and available
training and technical assistance. Applications may include, but are not
limited to, the development and testing of new and innovative
Internet-based systems that provide practitioners with (a) current
information on evidence-based treatments with the greatest promise for
defined populations of drug abusers; (b) assistance in translating
clinical trials data into clinically useful information; (c) information
and training on how to effectively organize, manage, and deliver
evidence-based prevention and treatment services; (d) strategies for
organizational change and capacity building; and (e) access to training
and technical assistance on the adoption of new prevention and treatment
interventions.

6\. *[New Technologies for Screening, Assessing, and Preventing Problem
Drug Use and Matching Patients with Appropriate Treatment
Services.]{.underline}* Increased understanding of the complexities of
problem drug use has sparked growing interest in and increased need for
new user-friendly technologies to assist in the screening, assessment,
and prevention of drug abuse and in the matching of patients with
appropriate treatment services. New technologies, including CD-ROM,
hand-held, Internet, videotape, videodisc, and other electronic means
have great potential for helping treatment providers in specialty and
non-specialty care settings including primary care contexts to (a)
screen for problem drug use and associated health problems and risk
behaviors, (b) assess the nature and degree of drug use, (c) embed items
for screening or assessing problem drug use within existing clinical
tools, (d) deliver appropriate prevention interventions, and (e)
identify appropriate types and levels of treatment services for patients
based on their individual treatment needs. These new technologies
potentially can provide a more cost effective way of identifying problem
drug use and associated health problems in a variety of health care
settings, speeding the assessment process, preventing the escalation of
use to abuse, and improving treatment placement decisions.

Jerry Flanzer, Ph.D.

\(301\) 443-4060

Email: <jflanzer@nih.gov>

7\. *[Reintegration of Criminal Offenders into the
Community.]{.underline}* Many offenders enter the criminal justice
system with drug abuse problems and related health issues. In addition
to addressing these health care issues within the prison walls,
treatment programs are increasingly called upon to help offenders
successfully reintegrate into the community following incarceration.
This often means helping offenders to manage their recovery through
monitoring, linkage with continuing care services, development of social
support networks, and education of friends and family members about the
nature of drug abuse and the challenges facing the offender upon release
from prison. It is estimated that over the next several years, more than
600,000 criminal justice offenders, many of whom have drug abuse
problems, per year will be released to return to their communities. New
technologies are needed to help treatment providers in the criminal
justice system and in the community coordinate efforts to effectively
(a) monitor offenders' recovery once they have been released into the
community, (b) prevent relapse, (c) identify relapse early and
efficiently re-engage released offenders in appropriate treatment, (d)
link released offenders with continuing care services in the community,
(e) develop social support networks for recently released offenders in
recovery, and (e) educate offenders' family members so that they can
more effectively support offenders in recovery once they have been
released from prison.

Redonna Chandler, Ph.D.

\(301\) 443-6504

Email: <rchandle@nida.nih.gov>

[]{#__RefHeading___Toc124236928 .anchor}Office of Science Policy and
Communications (OSPC)

***[Science Education.]{.underline}*** In order to improve science
education in the area of drug abuse research (e.g., disciplines such as
neuroscience, psychology, epidemiology), efforts are needed to develop
innovative methods for improving knowledge of and generating interest in
science among school children, the general public, and health care
providers, including providers involved in drug abuse treatment. These
might include but are not limited to:

a\. Development of methodologies to present drug abuse and science
information to particular groups, such as kindergarten and elementary
school students, African Americans, Hispanics, persons with disabilities
and health care providers.

b\. Development of methodology to transfer new knowledge and directions
of scientific growth to teachers, curriculum developers and health care
providers.

c\. Development of computer based learning systems that allow students
to experience the scientific process.

d\. Development of specific materials, activities, or programs that
promote science education related to drug abuse, such as exhibits,
curriculum materials, coloring books, videos, teacher education
workshops, partnership programs with scientists and educators, or
workshops for health care providers.

e\. Development of specific materials, activities or programs that
promote the teaching of scientific and research ethics to middle and
high school students.

Cathrine Sasek, Ph.D.

\(301\) 443-6071

Email: <csasek@nih.gov>

[]{#__RefHeading___Toc124236929 .anchor}International Program

NIDA's International Program develops and disseminates important new
information on the causes, consequences, prevention and treatment of
drug abuse and addiction that will help address the growing problems
related to illegal drug use and addiction around the world.

NIDA's International Program is currently interested in supporting
US-based small businesses to develop products and services in the
following areas:

1\. To date opportunities for collaborators to meet have been through an
intermediary or sometimes chance meetings. Efforts are needed to use
state of the art computer technologies to assist researchers in forming
collaborations to further research opportunities.

2\. Use of state of the art computer technologies to provide grant
writing and other research education skills to US and international
audiences.

3\. Development of accurate translations of valid and reliable
questionnaires, surveys, interviews, and other instruments for use in
domestic and international settings.

4\. To facilitate research collaborations between US and international
researchers, and to respond to the demand for science based drug abuse
information, there is a need for the development of a series of
information and training modules specially targeted to foreign trainees
and investigators. Proposed topics for the modules include, but are not
limited to: Drug Abuse Treatment Approaches, Understanding the
Neuroscience of Addiction, Tools and Guidelines for Assessing and
Evaluating Drug Abuse Treatment Programs and Treatment Approaches with
HIV-Positive Drug Abusers.

Steve Gust, Ph.D.

301-443-6480

Email: <sgust@nida.nih.gov>

[]{#__RefHeading___Toc124236930 .anchor}Other Research Topic(s) Within
the Mission of the Institute

NIDA encourages applications in other areas of research that may not be
listed.

For additional information on research topics, contact:

Cathrine Sasek, Ph.D.

National Institute on Drug Abuse

6001 Executive Boulevard

Room 5230, MSC 9591

Bethesda, Maryland 20892-9591

\(301\) 443-6071, Fax: (301) 443-6277

Email: <csasek@nih.gov>

For administrative and business management questions, contact:

Diana Haikalis

Grants Management Specialist

National Institute on Drug Abuse

6001 Executive Boulevard,

Room 3119, MSC 9591

Bethesda, Maryland 20892-9591

\(301\) 443-6710, Fax: (301) 594-6849

Email: <dhaikali@mail.nih.gov>

[]{#__RefHeading___Toc124236931 .anchor}National Institute on Deafness
and Other Communication Disorders (NIDCD)

The NIDCD supports research on the normal mechanisms of, as well as on
diseases and disorders of hearing, balance, smell, taste, voice, speech
and language. The Institute also supports research related to disease
prevention and health promotion. The NIDCD addresses special biomedical
and behavioral problems associated with people who have communication
impairments or disorders. The NIDCD also supports efforts to create and
refine devices, as well as develop cellular-based applications that may
replace or substitute for lost and impaired sensory and communication
functions. For more specific information about areas of interest to the
NIDCD, please visit our home page at <http://www.nidcd.nih.gov/>.

[]{#__RefHeading___Toc124236932 .anchor}Phase II Competing Renewal
Awards

The NIDCD will accept Phase II SBIR/STTR Competing Renewal grant
applications to continue the process of developing products that require
approval of a Federal regulatory agency (e.g., FDA, FCC). Such products
include, but are not limited to: medical implants, drugs, vaccines, and
new treatment or diagnostic tools that require FDA approval.

The NIDCD will accept applications for up to two (2) years and up to
\$750,000 per year in total costs. This renewal grant should allow small
businesses to get to a stage where interest and investment by third
parties is more likely.

Please contact your Program Director or Lynn Luethke (NIDCD SBIR/STTR
coordinator) before beginning the process of putting an application
together. Prospective applicants are strongly encouraged to contact NIH
staff prior to submission of a Competing Renewal application.
Prospective applicants are strongly encouraged to submit to the program
contact a letter of intent that includes the following information:

-   Descriptive title of the proposed research

-   Name, address, and telephone number of the Principal Investigator

-   Names of other key personnel

-   Participating institutions

-   Funding Opportunity Announcement Number (e.g., PA-06-XXX)

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 NIH staff to estimate the potential review
workload and plan the review. It is expected that only a portion of
NIDCD SBIR/STTR Phase II awards will be eligible for a Competing Renewal
grant.

[]{#__RefHeading___Toc124236933 .anchor}Hearing Program

Research and development related to lost auditory function. Development
of new cellular and tissue-based applications, hearing aids, cochlear
implants, and other assistive devices (e.g., systems designed to improve
access to and to increase utilization of computer and other information
technologies, telecommunication devices, alerting systems) for
individuals with hearing impairments; development of molecular
technologies, including viral and non-viral vectors to enable gene
transfer to the inner ear; development of cell type specific markers and
probes to examine cell lineage in inner ear regeneration; development of
research tools such as software and imaging technologies; development of
relevant web or other databases; development of assays (including
DNA-based assays), tests and instruments for the screening and diagnosis
of hearing impairment, especially in neonates and infants; development
of treatment modalities to prevent or lessen the effects of hearing
disorders; development of new outcome measures for assessing the
efficacy of treatments of hearing disorders; development of new research
tools to aid in the study of the auditory system (e.g., imaging
techniques, neuroanatomic tracers, electrophysiologic technology, new
animal models); development of technologies for the study, diagnosis and
treatment of otitis media including non-invasive diagnostics to identify
middle ear pathogens, novel antibacterial strategies, and prophylactic
anti-microbial strategies.

Lynn E. Luethke, Ph.D.

National Institute on Deafness and Other Communication Disorders

\(301\) 402-3458, Fax: (301) 402-6251

Email: <luethkel@nidcd.nih.gov>

[]{#__RefHeading___Toc124236934 .anchor}Balance/Vestibular Program

Research on balance and vestibular function, including development of
tests and treatments for balance disorders. Balance disorders affect a
large proportion of the population, particularly the elderly. The
vestibular system, with its receptor organs located in the inner ear,
plays an important role in maintaining orientation in space, controlling
balance while the body is immobile and in motion, and visual fixation of
objects during head movement. Emphasis is on research and development of
treatments for balance disorders; development of neuroimaging
techniques, computational modeling, genetic tools and biochemical
markers of disease in the vestibular system; development of clinical
tests, instrumentation and software systems to assess balance/vestibular
function, including otolithic functions and eye movements associated
with the vestibulo-ocular reflex; development of instruments and tests
measuring head stability and vestibular function during natural
stimulation of the vestibular system including during locomotion;
development of perceptual reporting techniques and psychological indices
for the clinical assessment of the balance-disordered patient;
development of tests and new outcome measures for assessing the efficacy
of physical rehabilitative regimens for balance disorders; and
development of assistive devices for balance disorders, including
prostheses involving electrical stimulation of the vestibular system.

Christopher Platt, Ph.D.

National Institute on Deafness and Other Communication Disorders

\(301\) 496-1804, Fax: (301) 402-6251

Email: <plattc@nidcd.nih.gov>

[]{#__RefHeading___Toc124236935 .anchor}Voice, Speech, and Language
Programs

Research on voice, speech, and language disorders focuses on determining
the nature, causes, treatment and prevention of disorders such as
stuttering, spasmodic dysphonia, dysarthria, and aphasia. Emphasis is on
research and development of diagnostic measures and intervention
strategies for voice, speech, swallowing, and language disorders;
development of communication and other assistive devices for individuals
with voice, speech, swallowing, and language disorders; identification
and development of computer and animal models for research in
communication disorders; development of new systems for visual
communication by individuals who are deaf or severely hearing impaired;
development of new systems of communication for individuals with motor
impairment; design and development of diagnostic measures or materials
for early identification of speech and language impairment in children;
development of tests for the assessment of childhood and adult language
impairment in multi-cultural populations; development of assessment
measures of sign language abilities; development of improved artificial
larynges and tracheoesophageal shunts; development of artificial
intelligence computer models that simulate normal and disordered speech
and language.

Judith A. Cooper, Ph.D. \[Language Program\]

National Institute on Deafness and Other Communication Disorders

\(301\) 496-5061, Fax: (301) 402-6251

Email: <cooperj@nidcd.nih.gov>

Lana Shekim, Ph.D. \[Speech & Voice Program\]

National Institute on Deafness and Other Communication Disorders

\(301\) 496-5061, Fax: (301) 402-6251

Email: <shekiml@nidcd.nih.gov>

[]{#__RefHeading___Toc124236936 .anchor}Taste and Smell Program

The study of the chemical senses of taste and smell will lead to a
better understanding of how individuals communicate with their
environment and interact socially. Taste and smell perception regulates
food consumption and plays an important role in maintaining a nutritious
healthy diet. In addition, both the olfactory (smell) and gustatory
(taste) systems offer special approaches for understanding fundamental
mechanisms of neurogenesis, plasticity and regeneration in the brain.
Innovative approaches for obtaining functional expression of mammalian
taste or odor receptors in heterologous cells will help determine
ligand-receptor specificities and taste and smell quality perception.
The olfactory receptor neuron represents a model system for the study of
the biological processes related to stem cells. Advances in molecular
and cellular biology, biophysics, and biochemistry of the olfactory and
gustatory systems are paving the way for improved diagnosis, prevention,
and treatment of chemosensory disorders. Research on the development of
readily administered diagnostic tools for testing human chemosensory
function in population studies, intervention strategies for smell and
taste disorders, biosensors and electronic noses for medical and
industrial applications, and the development of an inventory of
chemicals at exceptional high purity have high priority.

Barry J. Davis, Ph.D.

National Institute on Deafness and Other Communication Disorders

\(301\) 402-3464, Fax: (301) 402-6251

Email: <davisb1@nidcd.nih.gov>

[]{#__RefHeading___Toc124236937 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Lynn E. Luethke, Ph.D.

National Institute on Deafness and Other Communication Disorders

\(301\) 402-3458, Fax: (301) 402-6251

Email: <luethkel@nidcd.nih.gov>

For administrative and business management questions, contact:

Mr. Christopher P. Myers

Grants Management Officer

National Institute on Deafness and Other Communication Disorders

\(301\) 402-0909, Fax: (301) 402-1758

Email: <myersc@nidcd.nih.gov>

[]{#__RefHeading___Toc124236938 .anchor}National Institute of Dental and
Craniofacial Research (NIDCR)

The NIDCR conducts and fosters research on the etiology, pathogenesis,
prevention, diagnosis, and treatment of oral, craniofacial and dental
diseases and conditions. For more specific information about areas of
interest to the NIDCR, please visit our home page at
[http://www.nidcr.nih.gov](http://www.nidcr.nih.gov/).

[]{#__RefHeading___Toc124236939 .anchor}Developmental Biology and
Mammalian Genetics

Emphasis is on the understanding of the development of tooth and bone,
and on the identification of the genetic and environmental contributions
to craniofacial disorders. The objective of this scientific program is
to elucidate the underlying causes of craniofacial disorders, thereby
advancing the fields of diagnosis, treatment, and prevention.

A. Develop and operate registries to track craniofacial birth defects,
diagnostic techniques, treatment protocols, and outcome assessments.

B. Develop and manage tissue banks and/or DNA libraries of samples from
patients with craniofacial birth defects and from unaffected relatives
to aid in prospective and retrospective epidemiology and linkage studies
to facilitate the discovery of genes involved in craniofacial
dysmorphologies.

C. Production of genetic and immunological markers specific for
developing craniofacial tissues (e.g., stage specific markers for
discreet populations of premigratory, migratory, and differentiating
neural crest cells).

D. Develop early pregnancy genetic tests to screen fetal cells in
maternal blood for genetic mutations involved in inherited syndrome and
non-syndrome craniofacial defects.

E. Develop instrumentation to improve the diagnosis and treatment of
inherited and acquired craniofacial defects.

F. Develop instrumentation and methods to more accurately measure
craniofacial growth in order to assess normal growth patterns as well as
the effects of treatment procedures.

G. Develop animal models possessing specific genetic craniofacial
anomalies for use in studies on the etiology of disease, gene
regulation, gene/environment analysis, and gene-product function and
development of treatment protocols.

H. Develop improved appliances to aid suckling by newborn infants with
cleft palate and cleft lip.

[]{#__RefHeading___Toc124236940 .anchor}Infectious Diseases and Immunity

Research relating to the etiology, pathogenesis, prevention, diagnosis
and treatment of infectious diseases of the oral cavity is supported by
the NIDCR. This includes research on practical ways to effectively use
the host immune system to prevent or treat oral infectious diseases and
microbial-induced inflammation. Infectious diseases of the oral cavity
include caries, periodontitis, candidiasis, peri-implantitis, pulpitis,
and various viral and fungal infections of the oral mucosa and research
on the diagnosis and prevention of oral manifestations of HIV infection
and AIDS.

A. Develop improved instrumentation, methodology, biomarkers or
molecular probes for the rapid diagnosis and measurement of infectious
diseases.

B. Develop diagnostic tests to determine host susceptibility to oral
infections.

C. Develop ways to overcome or eliminate the risk of oral infections in
persons who smoke or chew tobacco, drink alcohol, or are
immunosuppressed, have diabetes, are malnourished, or are
psychologically stressed.

D. Explore novel methods or agents to eradicate oral biofilms (dental
plaque) on teeth, oral soft tissues, and dental implants without
adversely effecting the normal oral flora.

E. Isolate, synthesize or prepare new antibiotics and antimicrobial
agents that can overcome bacterial and fungal resistance to current
compounds. Formulate combinatorial drug regimens to attack microbes
growing in oral biofilms (dental plaque).

F. Develop controlled release drug delivery systems for the prevention
and control of oral infectious diseases.

G. Develop biological response modifiers or other immunological
approaches to reduce or eliminate microbial-induced chronic inflammation
or the tissue destruction associated with chronic inflammation in the
oral cavity.

H. Develop improved animal or in vitro models of oral infectious
diseases to enable evaluation of pathogenesis and therapies.

I. Develop ways to interfere with microbial colonization and growth
through the use of antimicrobial agents and chemotherapy.

J. Establish needed services that will benefit oral health care
providers or research laboratories involved in the study or treatment of
oral infectious diseases. Such services might be facilities for:
software design; design and preparation of peptides and molecular
probes; establishing and culturing hybridomas; determining antimicrobial
sensitivity of microbes growing in biofilms (dental plaque) to drugs and
antibiotics; or high technology imaging.

K. Establish practical methods to increase host immune and non-immune
defenses against infectious diseases (e.g., vaccines, biological
response modifiers). Develop adjuvants to stimulate mucosal immunity.
Identify and characterize target antigens for favoring secretory
antibody production.

L. Identify and exploit the structural features of oral biofilms for
increased therapeutics delivery.

M. Develop methods for early diagnosis of oral opportunistic infections
in asymptomatic individuals exposed to HIV.

N. Develop diagnostic tests utilizing whole saliva and oral biopsies for
examination of local immune responses and for the assessment of disease
progression.

O. Develop computer programs to model biologically active peptide
regions of oral components that have anti-fungal, anti-bacterial and
anti-viral activities.

P. Develop substitutes of naturally occurring chemicals (phytochemicals)
known to have a role in controlling opportunistic infections induced by
HIV.

Q. Develop synthetic peptides and recombinant proteins of oral
components with anti-fungal, anti-bacterial and anti-viral, specifically
HIV, activities.

R. Develop controlled release delivery systems for local delivery of
synthetic peptides recombinant proteins with anti-fungal, anti-bacterial
and anti-HIV activities and of drugs.

S. Develop and/or improve innovative and highly sensitive molecular
techniques to examine changes of cytokines and other immune regulators,
and of viral load in oral tissues and fluids.

[]{#__RefHeading___Toc124236941 .anchor}Epithelial Cell Regulation and
Transformation

Emphasis is on the molecular mechanisms of oral epithelial cell
regulation and aberrations of these mechanisms as they relate to the
development and progression of diseases involving the oral mucosa
including oral neoplasias research related to early diagnosis,
prevention, and treatment of oral neoplasias.

A. Develop immunological methods, imaging techniques or genetic markers
for the early detection, diagnosis and prognosis of pre-malignant head
and neck lesions including oral carcinomas.

B. Develop methods for the rapid and specific detection of viruses
implicated in the etiology of oral cancer as well as the detection of
viral genes in pre-malignant and malignant head and neck lesions.

C. Develop immunotherapies (e.g. vaccines, gene therapies) effective
against viruses suspected to be etiologic agents in the induction of
pre-malignant and malignant head and neck lesions.

D. Develop novel techniques for the evaluation of chromosomal changes in
head and neck cancers.

E. Develop effective pharmacological, immunological and radiological
modalities for treatment of pre-malignant and malignant head and neck
lesions.

F. Develop novel technologies for the genetic and molecular-targeted
therapy of head and neck carcinomas.

G. Develop animal models of localized and metastatic head and neck
squamous cell carcinomas.

H. Develop novel genomic and proteomic, as well as micro and nano-sensor
technologies, that can aid in early detection of head and neck tumors
and can release therapeutic agents in tumor cells.

I. Develop regimens for the alleviation of the oral complications of
cancer therapy.

J. Develop novel technologies for using stem cells as therapeutics for
head and neck cancers.

[]{#__RefHeading___Toc124236942 .anchor}Mineralized Tissue and Salivary
Gland Physiology, Pharmacogenetics and Injury

Emphasis is on the physiology of bones, teeth and salivary glands,
craniofacial tissue damage and repair, and pharmacogenetics of agents
used for the treatment of craniofacial and oral diseases and disorders.

A. Develop standardized and more sensitive methods, instrumentation,
and/or devices to detect oral bone loss, assess alveolar bone quality,
and to monitor for bone repair.

B. Develop novel agents and vehicles for local inhibition of bone loss
and/or augmentation of bone growth for the treatment of periodontal
diseases or craniofacial reconstruction.

C. Develop better methods and instrumentation to detect and/or treat the
earliest signs of demineralized enamel that may develop into carious
lesions.

D. Develop novel methods and agents to promote scarless repair of cleft
lip and scarless cutaneous healing following craniofacial surgery.

E. Develop viral and non-viral vectors for salivary gene therapy and
gene therapeutics.

F. Develop non-invasive methods for the determination of the efficacy
and safety of artificial saliva, sialogogues and of their delivery
vehicles.

G. Develop apparatus for craniofacial bone distraction that is contained
entirely within the oral cavity.

H. Develop more efficient methods, materials, and devices for prevention
of injuries to the teeth, mouth, and face during athletic activities.

I. Develop diagnostic reagents and tests necessary to effectively use
changes in saliva to diagnose and monitor systemic health, specific
disease processes, drug therapy, genetic defects, nutritional status,
and age-specific therapy.

J. Develop and characterize immortalized normal human and animal
salivary gland epithelial cell lines with appropriate phenotypic
expression.

K. Develop genetic standards and diagnostics to predict an individual's
oral responses to drug treatment of responsiveness to drugs used for the
treatment of craniofacial, oral and dental diseases.

[]{#__RefHeading___Toc124236943 .anchor}Molecular and Cellular
Neuroscience

Emphasis is on research on chronic disabling diseases of the
oral-craniofacial-dental areas including chronic pain, neuropathies and
neurodegenerative disorders, diseases of the temporomandibular joint.

A. Develop improved techniques for measuring chemosensory, tactile,
kinesthetic, or proprioceptive function involving craniofacial
structures. Such measures may be useful in screening for deficits,
improving diagnosis, or for evaluating responses to dental treatments or
interventions.

B. Develop improved measures for assessing oral-motor coordination or
oral behaviors (e.g., swallowing, masticatory efficiency).

C. Develop improved biomarkers or treatments for neuropathic conditions
or neurodegenerative conditions affecting oral-craniofacial tissues or
structures.

D. Develop assays facilitating reliable evaluations of relationships
between hormonal or chronobiological variations and other risk factors
as these relate to onset or exacerbation of pain symptoms.

E. Develop improved in vitro or animal models for evaluating
biomechanical, wear, functional or systemic responses associated with
TMJ devices or engineered tissues.

F. Develop improved in vitro or animal models for assessing
pathobiological changes in the TMJ or masticatory muscles and improved
biochemical markers of joint degradation.

G. Develop innovative approaches to reduce foreign body reactions or to
improve surgical outcomes for prosthetic devices or bone grafts received
subsequent to failed alloplastic TMJ implants

H. Develop safe and effective biomaterials or procedures useful in
repairing the temporomandibular joint (TMJ) following trauma,
degenerative or inflammatory diseases processes, or
iatrogenically-induced pathology (e.g., failed TMJ implants).

I. Develop more efficient methods, materials, and appliances for
orthodontic tooth movement.

J. Discover and develop non-narcotic medications with particular
emphasis on chronic orofacial pain disorders.

[]{#__RefHeading___Toc124236944 .anchor}Biotechnology and Biomaterials

Emphasis is on the development of natural and synthetic materials to be
used for the repair, regeneration, restoration and reconstruction of
oral tissues and organs; on the development and improvement of
evaluation and measurement systems for the characterization of implanted
material properties; on their interactions as well as on their
performance under the conditions of the biological environment; and
finally on the development and/or improvement of new dental restorative
materials that are mercury free.

A. Develop strategies for the fabrication of site-specific repair and
regeneration systems (e.g., smart implants to specifically attach the
appropriate reparative cells).

B. Establish libraries of structural recognition epitopes (peptides,
carbohydrates) to screen biological activities (e.g., bacterial
adherence to soft and hard oral tissues).

C. Develop non-destructive methods for the characterization of material
properties in vivo and in vitro.

D. Develop synthetic analogues of oral/craniofacial tissues and organs.

E. Develop more sensitive methods to determine and measure the
interactions of materials with biological systems (e.g., material
biocompatibility and bioactivity in the oral environment).

F. Optimize imaging techniques for describing the architecture of oral
tissues and structures.

G. Develop computer and mathematical modeling systems capable of
mimicking biological tissues and of evaluating material designs.

H. Develop novel techniques for ensuring sterility of biomimetic
structures prior to implantation.

I. Develop delivery systems that are compatible with host immunity;
consider hybrids and artificial vectors as well as viral and non-viral
gene delivery systems with cell-type selectivity.

J. Develop in vitro methods that predict immunogenicity to vectors used
for gene transfer as well as for biomaterials.

K. Develop improved implantable materials, designs through
nanotechnology principles.

L. Develop improved surgical techniques for artificial implants to
support replacement of dental, oral and craniofacial tissues and organs.

M. Develop new and improved instruments and techniques for the diagnosis
and treatment of TMJDs.

N. Develop improved composite materials and adhesive sealants suitable
for restoring crowns of posterior teeth and exposed roots of teeth.

O. Utilize nanoscience and nanotechnology principles in the development
of new non-mercury containing dental restorative materials.

P. Design and development of orthodontic and other prosthetic
appliances.

Q. Develop tissue engineering and regenerative approaches to building
complex structures (e.g. teeth, ligaments, peridontum) in the oral
cavity.

[]{#__RefHeading___Toc124236945 .anchor}Clinical, Epidemiological, and
Behavioral Research

Provides support for clinical trials and patient-oriented research on
the safety, efficacy, and effectiveness of measures for diagnosing,
preventing, or treating oral, dental, and craniofacial conditions and
disorders, as well as for research on the distribution of such
disorders, risk and protective factors, oral health disparities, and
basic and applied behavioral, social science and health services
research relevant to oral diseases and their prevention or treatment.

A. Develop and test web-based training or other innovative approaches to
accelerate accurate translation of new knowledge regarding oral diseases
and their effective prevention/treatment into clinical or public health
practice.

B. Conduct studies to expand knowledge regarding specific oral health
consequences of using various smoked or smokeless tobacco products.

C. Develop reliable, sensitive, cost-effective measures for improved
assessment of oral health status in populations or population subgroups.

D. Develop and test the effectiveness of innovative teaching tools to
inform oral health professionals or the public regarding oral cancer
prevention and early detection.

E. Develop and test devices or methods to improve time-sampled
monitoring of behavioral adherence with preventive or therapeutic
regimens specifically relevant to oral diseases/conditions. Such devices
or methods could be utilized either within clinical trials or oral
health care delivery systems.

F. Develop novel compliance and survey tools to examine the underlying
causes of avoidance of preventive dentistry in underserved populations.

[]{#__RefHeading___Toc124236946 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Rosemarie Hunziker, Ph.D.

Director, Technology Development and Industrial Relations

Center for Biotechnology and Innovation

National Institute of Dental and Craniofacial Research

Natcher Building, Room 4AN 24K

Bethesda, MD 20892-6402

\(301\) 451-3888, Fax: (301) 480-8318

Email: <hunzikerr@nidcr.nih.gov>

For administrative and business management questions, contact:

Ms. Mary Daley

Chief Grants Management Officer

National Institute of Dental and Craniofacial Research

Building 45, Room 4AN-44B

45 Center Drive, MSC 6402

Bethesda, MD 20892-6402

\(301\) 594-4808, Fax: (301) 480-3562

Email: <md74u@nih.gov>

[]{#__RefHeading___Toc124236947 .anchor}National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK)

The NIDDK supports research in diabetes, endocrinology and metabolic
diseases; digestive diseases and nutrition; and kidney, urologic and
hematologic diseases. For additional information about areas of interest
to the NIDDK, please visit our home page at
[http://www.niddk.nih.gov](http://www.niddk.nih.gov/).

[]{#__RefHeading___Toc124236948 .anchor}Phase II Competing Renewal
Awards

NIDDK will accept Phase II SBIR/STTR Competing Renewal grant
applications to continue the process of developing products that
ultimately require 1) clinical evaluation, 2) approval by a Federal
regulatory agency, and 3) continuing refinements to durable medical
equipment (DME) designs such as cost reduction, testing for safety,
durability, and reliability, and meeting or establishing standards. This
renewal grant should allow small businesses to get to a stage where
interest and investment by third parties is more likely. Such products
include, but are not limited to biological products, devices, drugs,
medical implants, etc. related to the mission of the NIDDK. The
previously funded Phase II SBIR/STTR grant need not have been submitted
in response to a particular solicitation, as long as the research is
appropriate to the purpose of this solicitation. Budgets up to
\$1,000,000 total costs per year and time periods up to 3 years may be
requested for this Phase II Competing Renewal opportunity. An applicant
must provide evidence that they have contacted the Food and Drug
Administration (FDA) for guidance concerning the development of a drug,
biologic, or medical device. Such evidence should include FDA
correspondence regarding an investigational new drug (IND) application,
investigational device exemption (IDE), or pre-market notification
(510k) for the applicant\'s product development and the status of their
project in a timeline related to Federal regulatory approval processes.

Prospective applicants are strongly encouraged to contact NIH staff
listed at the end of this NIDDK topics announcement prior to submission
of a Competing Renewal application. Prospective applicants are strongly
encouraged to submit to the program contact a letter of intent that
includes the following information:

-   Descriptive title of the proposed research

-   Name, address, and telephone number of the Principal Investigator

-   Names of other key personnel

-   Participating institutions

-   Funding Opportunity Announcement Number (e.g., PA-06-XXX)

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 NIH staff to estimate the potential review
workload and plan the review. It is expected that only a portion of
SBIR/STTR Phase II awards will be eligible for a Competing Renewal
grant.

Examples of research that would be considered responsive to this
announcement are listed below for illustrative purposes and are not
exclusive of other appropriate activities.

-   Preclinical studies, including pharmacology and toxicology, beyond
    those conducted under the Phase I (R43) and initial Phase II (R44)
    grants.

-   Completion of studies as required by the Food and Drug
    Administration (FDA) for Investigational New Drug (IND) or
    Radioactive Drug Research Committee (RDRC) application.

-   Assessment of devices with regard to performance standards related
    to the FDA approval process.

-   Safety and effectiveness studies of novel medical devices and tissue
    engineered products.

-   Biocompatibility studies of surface materials of putative medical
    implants.

-   Evaluation of novel imaging approaches for diagnostic purposes.

-   Clinical studies in support of New Drug Application approval by the
    FDA.

-   Clinical studies in support of Pre-Market Approval for
    biomarkers/medical devices by the FDA.

[]{#__RefHeading___Toc124236949 .anchor}Diabetes, Endocrinology and
Metabolic Diseases

The Division of Diabetes, Endocrinology and Metabolic Diseases supports
basic and clinical research on the etiology, pathogenesis, prevention,
diagnosis, and treatment of diabetes mellitus and its complications;
endocrine diseases; osteoporosis; cystic fibrosis, and other metabolic
disorders; as well as research on basic endocrine and metabolic
processes. Research topics of potential interest to small businesses
include, but are not limited to:

I. Sensors and Delivery Devices:

A. Assessment of non-invasive, minimally invasive or implantable sensors
for monitoring blood or interstitial fluid glucose for prevention of
hypo- and hyperglycemia in diabetic patients.

B. Integration of glucose sensor and insulin delivery systems to create
an artificial pancreas.

C. Development of improved insulin delivery methods or devices.

D. Development of improved methods to assess and monitor metabolic
control.

II\. Screening Tests, Diagnostics and Biologic Tools:

A. Development of techniques or products useful for predicting,
preventing or delaying progression of diabetes and its complications,
including tests for identifying patients at risk, and methods of
monitoring disease progression.

B. Development of high throughput assays based on biologic pathways
likely involved in the pathogenesis of diabetes and its complications
that could be used to screen molecular libraries for novel therapeutic
agents.

C. Development and validation of animal models or surrogate markers to
monitor disease progression and potential therapies for diabetic
complications.

D. Development of strategies or tools to support the application of
behavioral approaches to risk reduction in the development of type 2
diabetes or to the improved treatment of diabetes. An important
consideration should be cost and practicability of use.

E. Development and validation of tools for use by health care
providers/systems to improve diabetes care and prevention.

F. Development of techniques and tools to identify islet cell
progenitors, methods to predict transplant success with recovered islet
preparations, and non-invasive imaging as well as other methods for the
*in vivo* measurement/ evaluation of pancreatic beta cell mass, function
or inflammation after transplantation of pancreatic islet/beta cells.

G. Development or improvement in diagnostic or screening tests for
cystic fibrosis.

H. Identification of new ligands for previously unclassified (orphan)
nuclear receptors and development of partial agonists or antagonists
with therapeutic potential for diseases such as diabetes and
osteoporosis, hormone-dependent cancers, and for conditions such as
obesity.

I. Development of Selective Receptor Modulators (SRMs) with tissue
specificity and profiles that provide beneficial effects without side
effects obtained from therapies based on naturally occurring hormones.

J. Development of simple inexpensive test for diagnosis of diabetes and
pre-diabetes that do not require fasting or timed blood sampling.

III\. Interventions and Therapies:

Diabetes

A. Development of immunomodulation/tolerance induction strategies to
prevent or slow progression of type 1 diabetes.

B. Development of new therapies to prevent, delay or treat diabetes or
its complications including strategies or tools to apply behavioral
approaches.

C. Development of methods that protect islet grafts after
transplantation, including the evaluation of alternative transplantation
sites, minimize the use of immunosuppression through
immunomodulation/tolerance induction or immunoisolation/encapsulation of
the graft from the host immune system, or support the use of single
donors for transplantation.

D. Development of methods that expand the number of human islets during
culture while still retaining appropriate functional islet
characteristics and the ability to be successfully transplanted.

E. Development of methods utilizing replenishable cell sources,
especially stem cells that produce functional islet like cells/tissues
that can be successfully transplanted.

F. Development of more reproducible methods that improve
yield/viability/function of islets prior to transplantation and the
engraftment and long term function of islets after transplantation.

Cystic Fibrosis and Inborn Errors

G. Development of potential therapeutics for CF including agents to
improve trafficking and function of mutant CFTR, to enhance activities
of channels which can serve as alternatives to CFTR, and to increase
transcription or translation of CFTR RNA.

H. Production of stabilized biologically active proteins or peptides
useful for enzyme replacement therapy.

I. Development of products useful in assessing or improving nutritional
status in patients with CF including improved pancreatic enzyme
preparations.

IV\. Genetic Testing and Genetic Therapies

A. Development of improved methods for the diagnostic, population or
newborn screening or prenatal testing for genetic metabolic diseases.

B. Improvements in the construction of gene therapy vectors to increase
transduction efficiency, level and duration of expression, and to
improve targeting.

C. Development of improved methods of manufacturing gene therapy vectors
that are scalable and improve titer and bioactivity of the vectors.

D. Development of new vector systems that improve the ability to
transduce nondividing cells such as hematopoietic stem cells, neurons,
hepatocytes or epithelial cells.

E. Development of techniques to achieve efficient homologous integration
or site-specific integration of introduced genes.

F. Development of approaches to gene transfer for cystic fibrosis by
improving gene delivery systems, improving tropism for target cells,
increasing efficiency and duration of transgene expression and
minimizing toxic effects.

V. Application of Proteomics and Metabolomics to Diabetes, its
Complications, and Other Endocrine and Metabolic Diseases

A. Identification of surrogate markers looking at the plasma/sera
proteome or metabolome at different stages of diabetes its complications
or other endocrine or metabolic diseases.

B. Development of novel proteomic or metabolomic technologies designed
to study diabetes its complications or other endocrine or metabolic
diseases.

C. Identification of novel drug targets or novel therapeutic agents
using proteomic approaches that might be relevant to diabetes its
complications or other endocrine or metabolic diseases.

D. Use of high throughput proteomic and metabolomic technologies for
toxicology studies of drugs that might be relevant to diabetes its
complications or other endocrine or metabolic diseases.

[]{#__RefHeading___Toc124236950 .anchor}Digestive Diseases and Nutrition

The Division of Digestive Diseases and Nutrition supports research on
the function, diseases and disorders of the digestive tract; the
esophagus, stomach, intestine, colon, anorectum, pancreas, liver,
gallbladder, and biliary tract; basic, clinical and behavioral research
on nutrition and obesity as well as information transfer in the field of
digestive diseases and prevention of obesity. Innovative
investigator-initiated projects that are not mentioned below are
encouraged. Areas that may be of interest to small businesses include,
but are not limited to:

I. Digestive and Liver Diseases (Clinical)

A. Development of assays to detect biomarkers for genetic predisposition
to GI-relevant diseases, e.g., IBD and IBS.

B. Development of new genetic screening methods for detection of
inherited digestive and nutritional disorders, e.g., hemochromatosis,
Wilson\'s disease, Crigler-Najjar syndrome, Alagille syndrome.

C. Development of improved means for detecting Barrett's esophagus.

D. Development of a non-invasive means of localizing GI bleeding beyond
the duodenum that is more sensitive than the Tc-RBC test.

E. Development of methods for gastrointestinal endoscopy without the
need for sedation.

F. Development, using rational drug design techniques, of agents that
interact with L-type calcium channels or with delayed rectifying
potassium channels to treat motility disorders (pseudo-obstructive
disorder, chronic constipation, and slow bowel transit).

G. Development of pharmaceutics from herbal preparations of promise for
therapy of digestive diseases, including liver diseases, involving
isolation of active components, preparation of pharmacologically pure
preparations, and testing for pharmacokinetics and activity in humans.

H. Development of novel antifibrotic therapies for progressive liver
failure.

I. Development of agents that would protect the gut epithelium from the
damage caused by chemotherapeutic agents.

J. Development of tests of hepatic "reserve" which would be of use, for
example, in assessing the risk of surgery in patients with liver
disease.

K. Development of agents to promote the repair of gut epithelium barrier
function, e.g., as needed following chemotherapy.

L. Development of drugs for dissolving gallstones in vivo.

M. Development of humanized monoclonal antibodies against HCV and HBV to
be used for prevention of recurrent disease in liver transplant
patients.

N. Development of surrogate markers for liver fibrosis and progression.

O. Development of a rapid, non-invasive diagnostic test for biliary
atresia.

II\. Digestive and Liver Diseases (Basic)

A. Development of detection methods for non-culturable forms of gut
enteric bacteria.

B. Development of molecular probes for the diagnosis of mucosal
dysplasia in inflammatory bowel disease.

C. Development of gut immune-modulators, or non-antigenic gliadin in
celiac disease.

D. Development of new techniques, including non-invasive imaging, to
measure motility/intestinal transit at various sites within the
gastrointestinal tract.

E. Development of techniques for the preservation and transplantation of
small intestine and pancreas.

F. Development of non-invasive measures of pancreatic exocrine function.

G. Development of a test for determining the hepatotoxic potential of
drugs, agents or additives that is more sensitive than testing in mice
and reflects the human response to the test compound.

H. Development of animal models to study hepatotoxic agents.

I. Improvements to existing imaging systems, or development of new ones,
to allow non-invasive detection of fibrotic, necrotic, inflamed, and
fatty livers prior to transplantation.

J. Development of non-invasive techniques to detect liver disease.

K. Development of non-invasive imaging methods to assess fatty liver in
patients.

L. Development of non-invasive devices/ techniques to measure portal
pressure for evaluating portal hypertension in patients with cirrhosis.

M. Development of an extracorporeal liver assist device to provide
temporary therapeutic assistance in cases such as fulminant hepatic
failure or drug overdose.

N. Development of non-occluding stents for use in the biliary tract and
in transjugular intra-hepatic porto-systemic shunts (TIPS).

O. Development of cryopreservation techniques for human hepatocytes that
would maximize viability and cell culture growth potential of thawed
cells.

P. Creation of artificial organs or development of effective xenographic
techniques for liver transplantation.

Q. Development of molecular standards for Hepatitis C virus quantitation
and typing.

R. Development of molecular standards for Hepatitis B virus quantitation
and typing.

S. Development of an economical, accurate, and fast test for glutens and
glidins in foods.

T. Development of humanized mouse models of multi-allelic diseases.

U. Development of measurements to quantitate phenotypic or metabolic
markers of disease progression in animal models, thus reducing the
numbers of animals needed.

III\. Nutrition

A. Development of a better method for measuring food intake patterns of
individuals that could replace recall.

B. Development of better methods for assessing overall nutritional
status.

C. Development of a non-invasive breath or blood test to accurately
measure dietary fat intake.

D. Development of biological measures, such as serum or urine tests, for
long-term dietary consumption of specific nutrients.

E. Development of better means of assessing energy intake and/or energy
expenditure (i.e., physical activity), e.g., a device to estimate
movement and relate this to calories expended with the goal of impacting
behavior and preventing obesity.

F. Development of better means to detect food borne pathogens with the
goals of (1) preventing their inclusion in foodstuffs and (2) better
treatment of acute infections.

IV\. Obesity and Eating Disorders

A. Development of safe drugs or herbal products that inhibit appetite or
increase energy expenditure.

B. Development of computerized interventions for weight-loss/maintenance
and/or increasing physical activity such as hand-held computers and
web-based programs.

C. Development of devices/equipment/ interventions to encourage
"activity" while performing sedentary work.

D. New technologies for quantitative assessment of intra-abdominal fat;
emphasis on technologies that are non-invasive, minimize the use of
ionizing radiation, and have the capability of being adapted for use in
the usual health care settings.

E. Development of more economical methods to produce 18-labelled oxygen
for use in energy expenditure studies and/or body composition studies
using doubly labeled water.

[]{#__RefHeading___Toc124236951 .anchor}Kidney, Urologic and Hematologic
Diseases

The Division of Kidney, Urologic, and Hematologic Diseases supports
research into basic mechanisms of organ and tissue function and into the
diseases of the kidney, urologic and hematologic systems. Projects to
help develop an understanding of the physiology, pathophysiology, and
related diseases of the kidney, urinary tract, and blood and blood
forming systems so that rational treatments and means of prevention
and/or arrest of diseases may be devised. Support for advances in the
technology of cell and molecular biology that will enhance research in
kidney, urologic and hematologic diseases is encouraged. Research
opportunities of interest to small businesses include, but are not
limited to:

I. Development of a Genomic Toolbox for Study of Kidney, Prostate,
Bladder, or Red Cells, which would include:

A. Library generation and gene identification from whole organ or rare
compartments in normal, developing, or injured tissues.

B. Antibodies or phage libraries that will facilitate the prospective
identification and purification of renal cell types.

C. Strategies to deal with the anatomical complexity, increase the
representation of low abundance transcripts, or decrease the redundant
sequencing of over-represented or known genes.

D. Bioinformatic tools.

E. Flexible databases useful for designing organ-specific databases and
websites.

F. Techniques for visualizing RNA distribution within cells or tissues.

G. New methods to acquire material from archival samples.

II\. Kidney

A. Development of antibodies or phage libraries specific for the
individual cell types of the kidney.

B. Development of both data and cell banks of diabetic kidney disease
families and autosomal and recessive polycystic disease families for use
by the research community.

C. Development of pharmacological agents that might be used to intervene
in acute or chronic renal disorders and in disorders of renal
hemodynamics, blood pressure, and extracellular volume regulation.

D. Means to improve physiologic homeostasis in maintenance dialysis
therapy through the:

1\. Improvement of blood access to permit continuous access to the
circulation.

2\. Development of means to provide for continuous anticoagulation.

3\. Development of reliable, non-invasive, online hemodialysis
monitoring systems assessing real-time treatment parameters such as
blood volume, access flow, and urea clearance.

E. Studies to improve the efficiency of maintenance dialysis:

1\. Development of innovative methods to produce more efficient and less
morbid forms of renal dialysis (e.g., GI dialysis, artificial kidney).

2\. Studies on biocompatibility of artificial kidney membranes, in
surface sensitive proteins, complement, and clotting mechanisms.

3\. Development of new agents for sterilizing dialysis membranes.

4\. Development of new dialysis membranes to diminish the duration of
dialysis treatments.

F. Improved techniques of preservation and storage of kidneys intended
for transplantation.

G. Development of material(s) for construction of urinary catheters that
may reduce the incidence of infection in the urinary tract.

H. Development of improved renal imaging techniques, differential renal
function assessments and diagnostic distinction between benign and
malignant parenchymal diseases.

I. Development of early diagnostic tools, preventative measures, and
treatment modalities for Acute Renal Failure.

J. Identification of mediators of renal failure during sepsis and
pharmacological means to block these effects.

K. Development of new non-invasive methods for measuring kidney
function:

1\. Reliable, non-invasive, non-radioactive methods of measuring
glomerular filtration rate (GFR).

2\. Identification and description of physiologic compounds that are
filtered by the kidney, but neither secreted or reabsorbed;

3\. Identification of serum factors released by damaged kidney cells.

4\. Characterization of changes in kidney hormonal function in kidney
disease at various stages of severity.

5\. Development of new biomarkers for early detection of kidney
dysfunction, prediction of progression, and early indication of
recovery.

6\. Development of rapid, accurate, and cost effective means of
quantifying urine albumin.

III\. Urology

A. Study of the effect of growth factors, hormonal concentrations and
other biochemical stimuli on the growth of prostatic tissue. Analyses of
factors responsible for initiation and progression of Benign Prostatic
Hyperplasia (BPH).

B. Development of animal or in-vitro models for the study of stromal -
epithelial interactions in BPH.

C. Assessment of factors responsible for Benign Prostatic Hyperplasia
(BPH) induced uropathy.

D. Host-parasite and bacteria-urothelial cell interactions involved in
urinary tract infection.

E. Kinetics of renal stone formation, such as characterization of growth
and dissolution, or crystal growth inhibition, and definition of
reliable biochemical profiles of stone forming patients.

F. Development of additional therapeutic agents for prevention and/or
treatment of urolithiasis.

G. Neuropharmacological-neurophysiological assessments in urodynamics.

H. Development of culture conditions for in vitro culture of cells from
benign prostatic hyperplasia.

I. Development of serum or urine markers that correlate with prostate
size to evaluate rate of growth.

J. Development of non-invasive instrumentation that can detect early
onset of bladder instability associated with diabetes mellitus.

IV\. Hematology

A. Development of methods and equipment for routine high volume
isolation of highly purified hematopoietic stem and progenitor
populations.

B. Identification of new methods to assay hematopoietic stem and
progenitor cells with short- and long- term repopulation models amenable
to serial examination.

C. Development of chemically defined reagents that support hematopoietic
stem cell proliferation and differentiation.

D. Definition of culture conditions using serum-free medium that will
support the ex vivo expansion of hematopoietic stem and progenitor
cells.

E. Development of new approaches for identifying, isolating, and
genetically analyzing fetal erythrocytes in the maternal circulation.

F. Development of novel methods for the delivery of DNA, proteins, and
other compounds to hematopoietic stem cells.

G. Development of rapid, high throughput microarrays for accurate
assessment of gene expression profiles of hematopoietic stem cells.

H. Development of non-invasive systems for monitoring the total
hemoglobin and hematocrit, suitable for use with adults or neonates.

I. Application of nanotechnology to the measurement of blood parameters
and diagnosis of blood disorders.

J. Development of new methods for the non-invasive or minimally invasive
measurement of body iron.

K. Adaptation of MRI technology for the non-invasive measurement of body
iron:

1\. Develop appropriate MR measurement method(s).

2\. Optimize RF coils for the body region of interest (primarily heart,
liver, and pancreas).

3\. Develop magnets of the appropriate magnetic field strength(s).

4\. Develop a reliable method for calibrating and validating iron
concentration detected by magnetic resonance imaging.

5\. Determine the most appropriate magnetic resonance method for
determining relaxation times and susceptibility.

6\. Develop indicator materials for direct MR measurement of iron
concentration.

L. Design of therapeutic drugs for inducing fetal hemoglobin synthesis.

[]{#__RefHeading___Toc124236952 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Diabetes, Endocrinology and Metabolic Diseases

*[Diabetes Complications, Interventions and Therapies]{.underline}*

Dr. Teresa Jones

\(301\) 435-2996, Fax: (301) 480-3503

Email: <tj104e@nih.gov>

*[Sensors/Delivery Devices and Screening, Diagnostics and Biologic
Tools]{.underline}*

Dr. Karen Teff

National Institute of Diabetes and Digestive and Kidney Diseases

\(301\) 594-8817; Fax: (301) 480-3503

Email: <kt216q@nih.gov>

*[Islet Transplantation and Drug Development]{.underline}*

Dr. Guillermo Arreaza

\(301\) 594-8813, Fax: (301) 480-3510

Email: <ga96b@nih.gov>

*[Diabetes Behavioral Therapy and Prevention]{.underline}*

Dr. Sanford Garfield

National Institute of Diabetes and Digestive and Kidney Diseases

\(301\) 594-8803, Fax: (301) 480-6271

Email: <sg50o@nih.gov>

*[Gene Therapy, Metabolic Diseases, and Cystic Fibrosis]{.underline}*

Dr. Catherine McKeon

National Institute of Diabetes and Digestive and Kidney Diseases

\(301\) 594-8810; Fax: (301) 480-3503

Email: <cm76w@nih.gov>

*[Proteomics and Metabolic Profiling]{.underline}*

Dr. Salvatore Sechi

National Institute of Diabetes and Digestive and Kidney Diseases

\(301\) 594-8814; Fax: (480) 8814

Email: <ss24q@nih.gov>

Digestive Diseases and Nutrition

Ms. Christine Densmore

National Institute of Diabetes and Digestive and Kidney Diseases

(301)402-8714, Fax: (301) 480-8300

Email: <cd121z@nih.gov>

Kidney, Urologic and Hematologic Diseases

*[Kidney]{.underline}*

Dr. Marva Moxey-Mims

National Institute of Diabetes and Digestive and Kidney Diseases

\(301\) 594-7717, Fax: (301) 480-3510

Email: <mm726k@nih.gov>

*[Urology]{.underline}*

Dr. Chris Mullins

National Institute of Diabetes and Digestive and Kidney Diseases

\(301\) 594-7717; Fax: (301) 480-3510

Email: <cm419z@nih.gov>

*[Hematology]{.underline}*

Dr. Terry Bishop

National Institute of Diabetes and Digestive and Kidney Diseases

\(301\) 594-7717, Fax: (301) 480-3510

Email: <tb232j@nih.gov>

For administrative and business management questions, contact:

Ms. Helen Y. Ling

Senior Grants Management Specialist

National Institute of Diabetes and Digestive and Kidney Diseases

2 Democracy Plaza

6707 Democracy Blvd, Room 732

Bethesda, MD 20892-5456

\(301\) 594-8857, Fax: (301) 480-3504

Email: [lingh@extra.niddk.nih.gov](mailto:lingh@extra.niddk.nih.go)

[]{#__RefHeading___Toc124236953 .anchor}National Institute of
Environmental Health Sciences (NIEHS)

Human health and human disease result from three interactive elements:
environmental exposures, genetic susceptibility and age. The mission of
the NIEHS is to reduce the burden of human disease and dysfunction from
environmental causes by understanding each of these components and how
they interrelate. NIEHS achieves its mission through a multidisciplinary
biomedical research program, prevention and intervention efforts, and a
communication strategy that encompasses training, education, and
technology transfer and community outreach. NIEHS supports research and
training focused on the identification, assessment and mechanism of
action of agents in the environment and how they contribute to disease
and dysfunction. The ultimate goal of these NIEHS activities is to then
transfer this knowledge for the public benefit. The SBIR program uses a
combination of research, technology transfer and communication
strategies to aid the mission of NIEHS.

For additional information about the areas of interest to NIEHS, visit
our home page at [http://www.niehs.nih.gov](http://www.niehs.nih.gov/).

[]{#__RefHeading___Toc124236954 .anchor}Exposure Biology Program

Fundamental to the NIEHS mission is the ability to quantify an
individual's exposure, as well as the unique characteristics that
account for individualized responses to the exposures. The goal of this
exposure biology program is to develop new technology and assays to
generate precise measurements of human exposure to chemical and
biological agents that may lead to disease or dysfunction. For the
purpose of this solicitation the focus of this program will be on
respiratory disease or reproduction and development. For example,
exposures to microbial toxins, particulates, and ozone may result in a
spectrum of respiratory effects ranging from allergic sensitization and
immune reactivity to chronic lung disease. Exposures to other
environmental agents such as pesticides, phthalates, and polybrominated
biphenyl ethers (PBDEs) may result in adverse effects on outcomes of
pregnancy and development. The desired application of these technologies
and assays is in population-based (epidemiological) or clinical research
and practice.

It is anticipated that the new technologies and assays, such as those
based on micro- and nanotechnology and molecular imaging, may provide
sensitive, high throughput, and potentially portable systems capable of
measuring environmental exposures and the impact of the exposures on
human biology. Ideally, such technologies and assays will provide
exposure measurements with a high degree of temporal and spatial
resolution; that is, they will provide real-time measurements of
exposure (high temporal resolution) as an individual moves from location
to location (high spatial resolution). Additionally, the technologies
and assays will be able to provide precise, quantitative measurements of
both current (and ongoing) exposures and/or past exposures, depending on
the exposure agent measured.

1\. Technologies for generating precise measures of Environmental
Exposures

NIEHS is interested in developing and validating new products/devices,
tools, assays to improve our ability to precisely measure environmental
exposures to individuals with high temporal and spatial resolution.
Ideally, the technologies, tools and assays will be of appropriate scale
to be field deployable and/or wearable. Exposures of interest are those
related to respiratory diseases, adverse effects on reproduction and
development as well as bioterrorism agents(nerve agents, choking agents,
metabolic poisons and blistering agents). Examples include:

A. Novel technologies and assays to generate precise, quantitative
measures of human exposure at the point of contact (e.g., skin, breath,
nasal mucosa).

B. Remote sensing technologies for detecting, quantifying, and
monitoring household exposures to toxicants and/or bioaerosols.

C. Micro- and nano-scale technologies, such as lab-on-chip sensors, for
detecting and quantifying simultaneously multiple environmental exposure
agents in a specific chemical or biological class in environmental
samples collected in the personal environment (e.g., breathing zone,
clothing, household,

D. Field deployable diagnostic devices capable of assaying biomarkers
indicative of specific exposures in biological samples encountered in a
mass casualty situation.

2\. Technologies for generating precise measures of biological response
to Environmental Exposures

NIEHS is interested in developing technologies and methods to generate
precise indicators (or markers) of the biological response to
environmental exposures related to respiratory diseases and adverse
effects on reproduction and development. The indicators may reflect
compensatory biological responses and/or early (preclinical) responses
to the exposure agent. The goal is to develop quantitative indicators
(or markers) that can be measured non-invasively in human
population-based and clinical research and practice. The exposure
markers may reflect either acute or chronic responses related to
toxicity or preclinical disease. Examples include:

A. Development of high-throughout and sensitive technologies and assays
for the detection and quantification of molecular changes in genes,
proteins, or metabolites, that are reflective of the early response to
environmental exposure, in samples of blood, urine, saliva, nasal
mucosa, fat and other biological samples.

B. Wearable devices for rapid, real-time monitoring of physiological
parameters such as heart rate, blood pressure, caloric output, blood
oxygen, and blood glucose, which may modulate the response to
environmental chemicals and biological agents.

C. Technologies and assays for identifying high-risk individuals for
respiratory diseases and adverse effects on reproduction and development
based on environmental exposure measures and genetics.

D. Identification of early (preclinical) response markers in animal
models that have direct application to marker development and validation
in population-based and clinical studies.

E Devices for assessing not only biomarkers of exposure but also
distinguishing those exposed individuals at risk of developing
life-threatening symptoms or long term chronic sequelae from their
exposure.

[]{#__RefHeading___Toc124236955 .anchor}Hazardous Waste Assessment,
Evaluation and Remediation Program

NIEHS is interested in applying biotechnology and bioengineering
approaches for the development of novel strategies that can be used to
characterize and monitor contaminants at waste sites, and to reduce
exposure via remediation technologies. In addition there is interest in
developing products for better site characterization that includes
improved monitoring capabilities to assess the extent and amount of
contaminants present at sites, as well as to monitor the effectiveness
of remediation technology in reducing the amount and toxicity of
contaminants. Examples include but are not limited to:

A. Development of nano structures, electrochemical methods,
photocatalytic processes, thermal treatments or filtration-based methods
of remediation.

B. Development of bioremediation and phytoremediation technologies
including the use of genetic engineering approaches.

C. Development of model organisms for site characterization that monitor
genomic responses to environmental exposures, with a special interest in
metals.

D. Development of technologies to determine the extent to which a
contaminant is bioavailable .

E. Development of methods/instruments to detect and measure non-aqueous
phase liquids and dense non-aqueous phase liquids in the subsurface.

F. Development of instruments to identify subsurface geological
structures and hydro-geological configurations and to sample for the
presence of contaminants in these structures.

[]{#__RefHeading___Toc124236956 .anchor}Predictive Test Systems for
Safety Evaluation Program

NIEHS is interested in developing, standardizing, and validating
sensitive and specific new and novel tests or batteries of tests that
will provide faster and less expensive alternatives to the use of
standard laboratory animal tests,( i.e., assays for carcinogenicity,
immunotoxicity, reproductive or developmental toxicity, dermal toxicity,
and neuro or other organ system toxicity including acute local and
systemic toxicity). The proposed tests should use cell cultures or
animal models that are relevant to human experience and can be
extrapolated to estimate risk to humans. The NIEHS is interested in
developing both high throughput screens that can be used to prioritize
chemicals for definitive testing and in developing specific tests that
meet regulatory requirements for toxicity tests. The endpoints for these
assays should take advantage of the new technologies such as genomics,
transcriptomics, proteomics, and bioinformatics and of novel endpoints
(biomarkers) including those that are non-invasive. Examples include but
are not limited to:

A. Biokinetic models that include the integration of toxicodynamic and
biokinetic modeling to predict systemic toxicity.

B. In vitro test methods (e.g., undifferentiated/ differentiated
human/mammalian cell model systems, organotypic model systems) that can
be used to predict acute and chronic toxicity by taking into account,
for example, metabolism, the ability of chemicals to pass through
barriers (i.e., blood brain, kidney, lung, gastrointestinal), and organ
specific effects, or which allow the development of endpoints that can
be extrapolated to in vivo biomarkers of toxicity.

C. Alternative assays to determine dermal irritation, dermal absorption,
dermal hypersensitivity phototoxicity, and ocular toxicity.

D. Non-mammalian or invertebrate models for specific toxicities that
utilize endpoint that are conserved across species so the results can be
extrapolated to human risk.

[]{#__RefHeading___Toc124236957 .anchor}Educational and Training
Resources Program

NIEHS is interested in developing educational and training resources for
students of all ages, educators, health care professionals and the lay
community to enhance their knowledge of environmental health sciences.
These resources are an important part of our communication strategy that
encompasses training, education, and community outreach. Resources may
be directed at all levels of education: Kindergarten through 12^th^
grade, undergraduate, graduate, adult education, health care
professional training, and community outreach. Products may include:

A. Web-based interactive lessons, training modules and educational games
that can be used in the classroom as well as in the home.

B. Innovative communication strategies for distance learning (e.g.
satellite broadcasting, video conferencing, webcasting, Personal Digital
Assistant programs, etc.) to enhance educational and training
opportunities.

C. Video and DVD-based educational outreach materials that can be used
in the classroom, at community meetings, or for professional
development, including continuing medical education courses.

D. Educational television shows (e.g., PBS Kids, NOVA, etc.) with
accompanying lessons or activities (accessible via internet or print)
that can be used by teachers, parents or professional development
coordinators.

Resources on subjects of particular interest include, risk assessment,
hazards in our environment, use of pesticides, endocrine disruptors,
air/soil/water quality, susceptibility/gene-environment interactions,
ethical, legal, and social implications of environmental health
research, health disparities, and intervention/prevention strategies.

Educational and training materials must be aligned with state and
federal standards. Training materials and activities for health care
professionals should include continuing education units. Partnerships
are encouraged among small businesses, environmental health scientists,
and educators, health literacy experts or training specialists.

For more information on NIEHS Science Education activities, visit
[www.niehs.nih.gov/science-education/](http://www.niehs.nih.gov/science-education/).

[]{#__RefHeading___Toc124236958 .anchor}Other Topics Within the Mission
of the Institute

For additional information on research topics, contact:

Dr. Jerrold J. Heindel

National Institute of Environmental Health Sciences

Division of Extramural Research and Training

POB 121233 (EC-23)

Research Triangle Park, NC 27709

\(919\) 541-0781, Fax: (919) 541-5064

Email: <heindelj@niehs.nih.gov>

For administrative and business management questions, contact:

Mr. Dwight Dolby

Grants Management Specialist

National Institute of Environmental Health Sciences

Division of Extramural Research and Training

Research Triangle Park, NC 27709

\(919\) 541-7824, Fax: (919) 541-2860

Email: <dolby@niehs.nih.gov>

[]{#__RefHeading___Toc124236959 .anchor}National Eye Institute (NEI)

The NEI supports research with respect to blinding eye diseases, visual
disorders, mechanisms of normal visual function, preservation of sight,
and the special health problems and requirements of individuals with
impaired vision. Proposals for all areas in basic and clinical vision
research are encouraged. Some examples are listed below.

With recent advances in genomics and proteomics, the NEI is interested
in providing support for the development of new technologies,
strategies, research tools, reagents and methods that can be applied to
basic and translational research which will benefit vision health.

The NEI\'s programs are described in extensive detail in documents which
are available from the Institute. For additional information about the
research programs of the NEI, please visit our home page at
[http://www.nei.nih.gov](http://www.nei.nih.gov/).

[]{#__RefHeading___Toc124236960 .anchor}Retinal Diseases Program

Research and development of new therapeutic approaches for ocular
inflammatory diseases and to inhibit abnormal proliferation of the
retinal and choroidal blood vessels; development of better methods of
diagnosing and treating diabetic retinopathy and other vascular diseases
of the retina and choroid; development of non-invasive techniques for
early diagnosis of macular degeneration and other retinal degenerative
diseases; development of instruments and procedures for improved
surgical management of retinal detachments; identification and
characterization of factors regulating retinal cellular proliferation
and development that will facilitate retinal regeneration and function.

[]{#__RefHeading___Toc124236961 .anchor}Corneal Diseases Program

Research and development of new therapeutic agents for the treatment of
corneal diseases; development of innovative methods of drug delivery for
ocular surface disorders; development of new biomaterials for corneal
prostheses; development of instruments and procedures for correcting the
refractive power of the cornea and measuring the cornea\'s optical and
physiological properties.

[]{#__RefHeading___Toc124236962 .anchor}Lens and Cataract Program

Research and development of therapeutic agents for the prevention of
cataract; development of new approaches in the post-operative management
of cataract surgery; development of new surgical instruments for
cataract extraction and biomaterials for replacement of the natural
lens.

[]{#__RefHeading___Toc124236963 .anchor}Glaucoma and Optic Neuropathies
Program

Research and development of new therapeutic agents, instruments, and
procedures for the diagnosis and treatment of glaucoma; development of
non-invasive methods to measure changes in the optic nerve head and
retinal fiber layer.

[]{#__RefHeading___Toc124236964 .anchor}Strabismus, Amblyopia, and
Visual Processing Program

Research into the identification and characterization of growth factors
which facilitate regeneration of visual nerve axons; development of
innovative techniques to study factors that facilitate regeneration and
guidance of developing or regenerating nerve fibers; development of new
approaches using imaging techniques, such as PET and MRI, to localize
lesions and test the functioning of specific parts of the visual system,
especially those involved in higher order visual processing and
oculomotor processing.

[]{#__RefHeading___Toc124236965 .anchor}Visual Impairment and Blindness
Program

Research and development of instruments and methods to better specify,
measure, and categorize residual visual function; development and
evaluation of optical, electronic, and other devices that meet the
rehabilitative needs of persons who are blind or have low vision.

[]{#__RefHeading___Toc124236966 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Ralph Helmsen, Ph.D.

National Eye Institute

\(301\) 451-2020, Fax: (301) 402-0528

Email: <rjh@nei.nih.gov>

For administrative and business management questions, contact:

Mr. William Darby

National Eye Institute

\(301\) 451-2020, Fax: (301) 496-9997

Email: <wwd@nei.nih.gov>

[]{#__RefHeading___Toc124236967 .anchor}National Institute of General
Medical Sciences (NIGMS)

The NIGMS supports research and research training in the basic medical
sciences and related natural and behavioral sciences and in specific
clinical areas (i.e., clinical pharmacology, trauma and burn injury, and
anesthesiology). The NIGMS also supports health-related research that is
otherwise not assigned to another of the PHS components. The three
divisions and one center that support research of potential interest to
small businesses and their collaborators include:

Division of Cell Biology and Biophysics

Division of Genetics and Developmental Biology

Division of Pharmacology, Physiology, and Biological Chemistry

Center for Bioinformatics and Computational Biology

For additional information about areas of interest to the NIGMS, please
visit our home page at
[http://www.nigms.nih.gov](http://www.nigms.nih.gov/). This site
includes staff contact information by program area
(<http://www.nigms.nih.gov/nigms_staff/contact.html>). It also includes
links to program announcements that highlight NIGMS areas of special
emphasis (<http://www.nigms.nih.gov/funding/funding.html>). In some
cases, these announcements specifically mention the SBIR and STTR grant
mechanisms, in most cases they do not. However, it is clear that small
businesses could make contributions to the research objectives described
in these announcements.

[]{#__RefHeading___Toc124236968 .anchor}Division of Cell Biology and
Biophysics

Research on membrane synthesis, structure, and function; membrane
models; membrane transport; cell division; cell organization; cell
motility; and biophysics of proteins, nucleic acids, and biological
assemblies, including viral entry, packaging, maturation, and release,
as well as the development of instrumentation, components, and methods
for the analysis of cellular components and macromolecules by imaging,
spectroscopy, and diffraction analysis.

SBIR and STTR proposals on the application of cell biology, biophysics,
biochemistry, physics, mathematics, and chemistry to biomedical
problems, and the development of instrumentation to facilitate research
in cell biology and biophysics, such as, but not limited to, the topics
listed below are welcome.

A. Development and improvement of methods for the expression,
solubilization, and purification of milligram quantities of regulatory,
cellular, and membrane associated proteins, as well as for the
preparation of specifically labeled macromolecules and the recovery of
proteins from inclusion bodies.

B. Development of novel ligands, inhibitors, and other probes for
spectroscopic and microscopic analysis of cellular assemblies and viral
structures, macromolecules and components, their localization and
function in vivo and at a single molecule level.

C. Development of instrumentation, devices, and methods for detecting in
real time, analyzing, and separating biologically important compounds,
macromolecules, and their interactions.

D. Development of new methods and materials directed toward the solution
of biological macromolecule structures by, but not limited to, x-ray
diffraction, electron diffraction, and NMR spectroscopy.

1\. New methods for the determination of the structures of membrane
associated proteins.

2\. New methods for the determination of macromolecular structures in a
high throughput mode, including improved detectors, data collection,
automated data analysis, and faster software for structure calculations
and comparisons.

3\. New methods designed to improve the efficiency of beam line use at
synchrotrons.

E. Development of technology for the imaging of molecules and cells,
including but not limited to:

1\. Reagents, methods, instrumentation and software for existing and
potential kinds of microscopy of molecules and cells (including light,
electron, X-ray, scanning probe, and others). Improved probes and
supporting technologies for dynamic (real-time) imaging of molecules and
molecular events in living cells by light microscopy.

2\. Reagents, methods, and software for conventional and cryo-electron
microscopy, including automated apparatus for controlled and
reproducible specimen preparation.

3\. Instrumentation, methods and technologies for analysis and
manipulation of cells, subcellular components, and single molecules,
including atomic force microscopy, atomic forceps and tweezers, and
solid state microscopy.

4\. Development of analytical systems and tools such as imaging systems
and probes, to be used at the nanoscale.

5\. Methods, probes, and data analysis for spectroscopy, including
magnetic resonance, fluorescence spectroscopy, and EPR.

F. Bioinformatics, including but not limited to:

1\. Development of databases relative to structural and cellular
biology.

2\. Development of methods for linking the information that might be
contained in such databases.

3\. Development of new tools that might be used for "mining" the
information contained in such databases.

G. Theoretical methods for, but not limited to:

1\. Analysis of macromolecular structures.

2\. Prediction of the three dimensional structures of biological
macromolecules.

3\. Improved methods for structure-based drug design.

4\. Improved methods for understanding complex systems at the cellular
and organism level.

H. Development of computerized tools that might be used in the
presentation of the concepts of cell and structural biology to audiences
at a variety of levels.

[]{#__RefHeading___Toc124236969 .anchor}Division of Genetics and
Developmental Biology

Research on developing a better understanding of fundamental processes
and mechanisms of development and inheritance in health and disease.
Support of basic topics in genetics and developmental biology, including
nucleic acid chemistry, the structure of genetic material, the
mechanisms of transmission and expression of genetic information,
cellular regulation of growth and differentiation, molecular immunology,
and population genetics. Areas that may be of interest to small
businesses include, but are not limited to:

A. Development of computer software for the analysis of the primary and
secondary structures of nucleic acids as these relate to genetic
problems.

B. Improvement in procedures for the separation and analysis of nucleic
acids and proteins as these relate to genetic problems.

C. Improvement of methodology (technology) for genetic analysis (e.g.,
gene libraries, cloning techniques, probes).

D. Development of probes for detection of human genetic polymorphisms,
including disease genes.

E. Development of improved procedures for cytogenetics.

F. Improvement in procedures (statistical, computational, laboratory)
for the analysis of gene flow and gene dynamics in human populations.

G. Development of improved vectors for gene transfer.

H. Development of valid animal models for genetic diseases.

I. Development of quantitative approaches to the analysis of complex
biological systems.

J. Development of new tools and models for study of the genetic
architecture of complex phenotypes.

K. Development of improved technology to scale up the growth of approved
human embryonic stem cells in culture and to regulate their
differentiation state.

L. Development of markers, reagents and tools to characterize the unique
properties of approved human embryonic stem cell lines and to
distinguish them from adult stem cells and more differentiated cells.

M. Development of human embryonic stem cell lines as a primary cell type
to be used as a model system for drug discovery.

N. Development or improvement of methodology for generation of
antibodies or other affinity reagents for proteins and other small
molecules in non-mammalian genetic model systems.

O. Development of methods for chemical modifications that improve the
properties of nucleic acids for gene silencing.

P. Improvement in procedures (statistical, computational, laboratory)
for the high- and medium-throughput analysis of gene expression patterns
and regulatory networks.

[]{#__RefHeading___Toc124236970 .anchor}Division of Pharmacology,
Physiology, and Biological Chemistry

Research related to the actions of therapeutics, including anesthetics,
and the development of biotechnological methods for their production and
investigation. Research on pain management as it relates to anesthesia
and the perioperative period. Research on responses to traumatic injury,
including burn injury, and methods to mitigate these responses. Research
leading to new knowledge of physiological functions at the molecular,
cellular, and organ systems levels. Research on the structure, function,
and biosynthesis of cellular components and cellular metabolism,
bioenergetics, and mechanisms of enzyme action, regulation, and
inhibition. Research leading to the synthesis of new materials or
development of new chemical methods to probe biological phenomena or to
alter the behavior of biological systems. Examples include, but are not
limited to:

A. Methods for isolation, characterization, and production of natural
and bio-engineered products.

1\. Metabolic engineering for the production of biochemicals through
genetic and bioengineering manipulation of biosynthetic pathways.

2\. Biosensors for use both in vivo and in vitro in process engineering.

B. Development of innovative synthetic chemistry.

1\. Catalytic asymmetric methods and methods for large-scale synthesis.

2\. New methods applicable to combinatorial library construction,
design, analysis, and/or handling.

3\. Improved methods for preparation of isotopically labeled amino
acids, peptides, proteins, and prosthetic groups, and therapeutic
agents.

C. Development of enzymes, catalytic antibodies, ribozymes, artificial
enzymes, and host molecules as drugs or synthetic tools.

1\. Synthesis of suicide substrates, affinity labeling agents, and
transition state analogs as potential therapeutic agents.

2\. New enzyme assays to reduce the reliance on radio-isotopes.

3\. General approaches for high throughput screening.

D. Isolation, characterization, and development of factors involved in
tissue repair and wound healing, i.e., growth factors. Tissue
engineering. Development of artificial skin and skin replacements.

E. Improved systems for collection, processing, and analysis of real
time physiological data from injured or critically ill patients.
Application of artificial intelligence or fuzzy logic and other methods
to model non-linear behavior in critically ill patients.

F. Systems to utilize virtual reality for surgical education and remote
surgical applications.

G. Research to improve drug design.

1\. Methods for understanding of structure-activity relationships.

2\. Mechanisms of drug-receptor interactions.

3\. Development of pro-drug and drug delivery strategies.

4\. Development of molecular diversity libraries.

H. Research to improve drug bioavailability by improved understanding of
factors that influence absorption, metabolism, transport, or clearance
of therapeutics and underlying mechanisms.

1\. Determination of structure-activity relationships for drug
metabolizing enzymes.

2\. Determination of structure-transport relationships for active and
passive transport of drugs and metabolites.

3\. Research on drug transporter structure, function, and regulation.

4\. Development and validation of models for prediction of drug
bioavailability and metabolism in humans.

5\. Research on inter- and intra-individual differences in
bioavailability.

6\. Methods to improve sensitivity, accuracy, speed, and simplicity for
measurements of drugs and their metabolites in complex biological
matrices.

I. Application of pharmacokinetic and pharmaceutical principles to the
study of large biomolecules, such as proteins, polypeptides, and
oligonucleotides.

J. Development of novel targeted delivery systems for both conventional
drugs and large molecules.

K. Research to discover, detect, and understand the genetic basis of
interindividual differences in drug responses.

1\. Identification of human polymorphisms in drug receptor and drug
metabolizing enzymes.

2\. Methods for pharmacogenetic and pharmacogenomic analyses and their
application to phenotypic and genotypic characterization of populations.

3\. Development of proteomic and metabolomic methodologies to support
research in this area.

4\. Development of appropriate databases, specimen, and cell culture
collections to support research in this area.

L. Development of novel in vivo and in vitro methods to predict
toxicities of pharmacologic agents.

M. Development of differentiated hepatic cell lines from human stem
cells that are equivalent to adult hepatocytes to characterize metabolic
profiles of pharmacological candidates by phase 1 and 2 enzymes.

N. Development of bioinformatic resources and/or pharmacokinetic
modeling programs which utilize ADME parameters of drugs and
pharmacogenomic information of individual patients or patient
populations to reduce adverse drug reactions in individual patients.

O. Development of methods for quantitating protein and lipid
glycoconjugates and for determining their structures. Development of
generally applicable methods for the synthesis of branched chain
oligosaccharides.

P. Development and application of methods and materials for the
elucidation of membrane protein structures at or near atomic resolution.

1\. Novel vector and host cell systems for over-expression of membrane
proteins, in both unlabeled and isotopically labeled forms.

2\. Novel and high purity detergents and non-detergent solubilization
agents for the purification and crystallization of membrane proteins.

3\. Apparatus to facilitate crystallization and manipulation of fragile
crystals for data collection.

4\. Reagents for heavy atom derivatization of membrane protein crystals.

Q. Development of high-throughput methods for sequencing and
resequencing of mitochondrial genes and relevant nuclear genes and for
proteomic profiling of mitochondria in diagnosis of mitochondrial
diseases.

R. Development of methods to create site-directed and knock-out
mutations of mitochondrially-encoded genes in higher eukaryotic cells
and experimental animals.

S. Development of new metal ion chelators and other tools to probe
and/or alter the localization and concentration of metal ions in cells
and in whole organisms. Research to exploit metal metabolism and
metal-regulated cellular control and cell-cell signaling processes to
probe and/or alter cell function. Research to develop investigational
and therapeutic applications of metal-complexes and to understand the
factors governing their pharmacology and toxicology.

T. Development of high-throughput methods and strategies to characterize
the function of proteins and enzymes and/or define the functional
interrelationships of proteins and enzymes.

U. Development of research tools to promote scientific collaboration in
any of the above areas of research. For example, applications software
for secure peer-to-peer networking to facilitate the exchange of
scientific data and research materials or to construct a searchable
distributed database.

[]{#__RefHeading___Toc124236971 .anchor}Center for Bioinformatics and
Computational Biology

A. Development and enhancement of databases for activities that fall
within the mission of NIGMS.

B. Development of methods for data mining and providing integration and
interoperability of different databases and varying modalities of data.

C. Development of tools to model complex biological systems that fall
within the mission of NIGMS.

D. Design and development of software and hardware for improving the
effectiveness of computational approaches in biomedical research.

[]{#__RefHeading___Toc124236972 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

*[Cell Biology and Biophysics]{.underline}*

Charles Edmonds, Ph.D.

National Institute of General Medical Sciences

\(301\) 594-0828, Fax: (301) 480-2004

Email: <edmondsc@nigms.nih.gov>

*[Genetics and Developmental Biology]{.underline}*

Matthew Portnoy, Ph.D.

National Institute of General Medical Sciences

\(301\) 594-0943, Fax: (301) 480-2228

Email: <mportnoy@nigms.nih.gov>

*[Pharmacology, Physiology, and Biological Chemistry]{.underline}*

Scott Somers, Ph.D.

National institute of General Medical Sciences

\(301\) 594-3827, Fax: (301) 480-2802

Email: <somerss@nigms.nih.gov>

*[Center for Bioinformatics and Computational Biology]{.underline}*

Peter Lyster, Ph.D.

National Institute of General Medical Sciences

\(301\) 451-6446, Fax: (301) 480-2802

Email: <lysterp@nigms.nih.gov>

For administrative and business management questions, contact:

Ms. Patrice Molnar

National Institute of General Medical Sciences

\(301\) 534-5136, Fax: (301) 480-2554

Email: <molnarp@nigms.nih.gov>

[]{#__RefHeading___Toc124236973 .anchor}National Heart, Lung, and Blood
Institute (NHLBI)

The NHLBI plans, conducts and supports research, clinical trials and
demonstration and education projects related to the causes, prevention,
diagnosis and treatment of heart, blood vessel, lung, and blood diseases
and sleep disorders. The NHLBI SBIR/STTR program fosters basic, applied,
and clinical research on all product and service development related to
the mission of the NHLBI. Research may be targeted to gender, race, or
age subgroups.

For more specific information about areas of interest to the NHLBI,
please visit our home page at
[http://www.nhlbi.nih.gov](http://www.nhlbi.nih.gov/).

Research topics of interest include, but are not limited to research and
development under the following specific initiatives as well as the
topic areas listed under each of the NHLBI Divisions below:

Directed Stem Cell Differentiation for Cell Based Therapies for Heart,
Lung, Blood, and Aging Diseases. See:
[http://grants.nih.gov/grants/guide/
pa-files/PA-06-124.html](http://grants.nih.gov/grants/guide/pa-files/PA-06-124.html)
(SBIR) and <http://grants.nih.gov/grants/guide/pa-files/PA-06-125>
(STTR)

Bioengineering Approaches to Energy Balance and Obesity. See:
<http://grants.nih.gov/grants/guide/pa-files/PA-06-055.html> (SBIR) and
<http://grants.nih.gov/grants/guide/pa-files/PA-06-056.html> (STTR)

Technologies for Monitoring and Performing Resuscitation. See:
[http://grants.nih.gov/grants/
guide/pa-files/PA-06-126.html](http://grants.nih.gov/grants/guide/pa-files/PA-06-126.html)
(SBIR) and <http://grants.nih.gov/grants/guide/pa-files/PA-06-127>
(STTR)

Development of Diagnostic Screening Test for Salt Sensitivity. See:
[http://grants.nih.gov/grants/guide/
pa-files/PA-06-033.html](http://grants.nih.gov/grants/guide/pa-files/PA-06-033.html)
(SBIR) and <http://grants.nih.gov/grants/guide/pa-files/PA-06-034.html>
(STTR)

[]{#__RefHeading___Toc124236974 .anchor}Phase II Competing Renewal
Awards

The NHLBI will accept Phase II SBIR Competing Renewal grant applications
from NHLBI-supported Phase II SBIR awardees that propose to perform
research required to obtain Food and Drug Administration (FDA)
acceptance or approval of the Phase II product in the form of an
Investigational New Drug (IND), Investigational Device Exemption (IDE),
510K, Pre-market Approval (PMA) or a Humanitarian Device Exemption
(HDE). This renewal grant should allow small businesses to get to a
stage where interest and investment by third parties is more likely.
Such products include, but are not limited to biological products,
devices, drugs, vaccines, medical implants, etc. related to the mission
of the NHLBI. The Competing Renewal application must be a renewal and
logical extension of a previously completed NHLBI-supported Phase II
(R44) SBIR grant. NHLBI grantees seeking SBIR Phase II Competing Renewal
funding must submit an application no later than the first six receipt
dates following expiration of the previous Phase II project budget
period.

Budgets up to \$1,000,000 total costs per year and time periods up to 3
years may be requested for this Phase II Competing Renewal opportunity.
An applicant must provide evidence that their research plan and
objectives follow FDA guidance for the development of a drug, biologic,
or medical device. Examples of acceptable FDA guidance includes, but is
not limited to, published guidelines and direct letters of communication
from FDA personnel for an investigational new drug (IND) application,
investigational device exemption (IDE), 510K, Pre-Market Approval (PMA),
or Humanitarian Device Exemption (HDE). The applicant should also
provide the status of their project in a timeline related to Federal
regulatory approval processes. An updated commercialization plan is also
required.

Prospective applicants are strongly encouraged to contact NHLBI program
staff prior to submission of an SBIR Phase II Competing Renewal
application. Although it is not required, prospective applicants are
strongly encouraged to submit to the program contact a letter of intent
that includes the following information:

-   Descriptive title of the proposed research

-   Name, address, and telephone number of the Principal Investigator

-   Names of other key personnel

-   Participating institutions

Examples of research that would be considered responsive to this
announcement are listed below for illustrative purposes and are not
exclusive of other appropriate activities.

-   FDA-required pre-clinical studies beyond those conducted under the
    Phase I (R43) and initial Phase II (R44) grants.

-   Completion of pre-clinical and clinical studies required by the FDA
    for an Investigational New Drug (IND) application and New Drug
    Application (NDA).

-   FDA-required pre-clinical and clinical safety and effectiveness
    studies of medical devices and tissue engineered products for an IDE
    or Pre-market Approval (PMA).

-   FDA-required biocompatibility studies of surface materials of
    putative medical implants or other studies needed for 510k approval.

-   FDA-required assessments of novel imaging systems.

Direct questions about scientific/research issues to:

Heart

J. Timothy Baldwin, Ph.D.

Division of Heart and Vascular Diseases

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 9150

Bethesda, MD 20892-9150

Telephone: (301) 435-0513

Fax: (301) 480-1335

Email: <baldwint@nhlbi.nih.gov>

Bishow Adhikari, Ph.D.

Division of Heart and Vascular Diseases

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 9161

Bethesda, MD 20892-9150

Phone: 301-435-0513

Fax: (301) 435-1335

Email: <adikarb@nhlbi.nih.gov>

Lung/Sleep

Mrs. Ann Rothgeb

Division of Lung Diseases

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 10124 (MSC 7952)

Bethesda, MD 20892-7952 (20817 for Courier)

Telephone: (301) 435-0202

Fax: (301) 480-3557

Email: <ar31t@nih.gov>

Blood

Phyllis Mitchell, M.S.

Division of Blood Diseases and Resources

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 10163(MSC 7950)

Bethesda, MD 20892-7950 (20817 for Courier)

Telephone: (301) 435-0481

Fax: (301) 480-1060

Email: <mitchelp@nhlbi.nih.gov>

Epidemiology and Clinical Applications

Paula T. Einhorn, M.D., M.S.

Division of Epidemiology and Clinical Applications

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 8001 (MSC 7936)

Bethesda, MD 20892-7936 (20817 for Courier)

Telephone: (301) 435-0563

Fax: (301)480-1669

Email: <einhornp@nhlbi.nih.gov>

[]{#__RefHeading___Toc124236975 .anchor}Heart and Vascular Diseases

The Division of Heart and Vascular Diseases plans and directs the
NHLBI\'s research grant, contract, and training programs in heart and
vascular diseases. These programs encompass institute- and
investigator-initiated basic research, targeted research, specialized
centers and clinical trials. The DHVD maintains surveillance over
developments in its program areas and assesses the national need for
research on the causes, prevention, diagnosis, and treatment of
cardiovascular disease. The DHVD ensures that effective new techniques,
treatments and strategies resulting from medical research are
transferred to the community through professional, patient, and public
education programs in a timely manner.

The Division has three major programs: the Heart Research Program, the
Vascular Biology Research Program, and the Clinical & Molecular Medicine
Program, in addition to a Research Training and Special Programs Group.

*[Heart Research Program]{.underline}*. Supports basic, applied, and
clinical research in cardiac diseases, from embryonic life to adulthood.

*[Vascular Biology Research Program]{.underline}*. Supports research in
atherosclerosis, hypertension, cerebrovascular disease, cardiovascular
complications of diabetes and obesity, basic vascular biology and gene
and cell-based therapy for the prevention and/or treatment of vascular
diseases.

*[Clinical & Molecular Medicine Program]{.underline}*. Supports
clinical, basic and engineering research on cardiovascular disease and
health. Its scope includes genetic, genomic and proteomic research;
cellular and molecular imaging; engineering theory and practice applied
to biology and medicine including therapeutic cardiovascular devices and
diagnostic instrumentation; nanotechnology; informatics and simulation;
and cohort, case-control, and randomized clinical trials.

Research topics of interest to the Division of Heart and Vascular
Diseases include but are not limited to the following:

A. Materials and Devices

1\. Angioscopes with increased flexibility and enhanced resolution.

2\. Medical implants (heart valves, vascular grafts, stents, pacemakers,
defibrillators, etc.).

a\. Novel designs and materials.

b\. Failure prediction/analysis.

c\. Manufacturing.

d\. Monitoring.

e\. Preservation methods.

f\. Quality assurance and quality control.

g\. Reference biomaterials for evaluation of biocompatibility.

h\. Reliability.

i\. Biological response

3\. Circulatory support systems.

a\. Artificial heart.

b\. Ventricular assistance.

c\. Automatic control.

d\. New animal models for in vivo testing.

e\. Percutaneous and transcutaneous transmission of electrical energy.

f\. Implantable rechargeable batteries and alternate power sources.

4\. Biological, chemical, and mechanical sensors.

5\. Diagnostic instrumentation for the mouse and rat.

B. Methods

1\. Resuscitation-enabling technologies.

2\. Tissue engineering approaches and technologies that can be used to
engineer functional tissue for repair or replacement of damaged or
diseased tissue.

3\. Development of phenotypic screening methods in the mouse for heart,
lung, and blood diseases and sleep disorders.

4\. Animal models for assessing genetic determinants of disease.

5\. Animal models of cardiovascular complications of diabetes mellitus.

6\. Nutrition and dietary interventions, products, software and
databases.

7\. Lipid measurements and standardization in fresh human serum, without
matrix effects.

8\. Systems biology approaches to study complex disease.

9\. Computational modeling approaches to study vessel wall biology.

10\. Mathematical and computer modeling of structure, function, and
electrical activity of the normal and diseased heart.

11\. Computer modeling of hemodynamics in complex congenital heart
disease.

12\. Metabolomics

13\. Development of new and improved antisense agents and RNA
interference (RNAi) technologies for cardiovascular disease therapies.

14\. Gene and gene product relationship, structure, and function.

15\. Gene discovery technologies.

16\. Genetics of complex diseases\--gene/gene and gene/environment
interactions.

17\. Gene assessment and diagnostic technologies.

18\. Non-invasive methods of detecting cardiac rejection, particularly
in infants and young children.

19\. Non-toxic and selective molecular cages for delivering short-lived
vasoactive agents to the vasculature.

20\. Preservation methods for cardiovascular tissues or organs for use
in transplantation and in research studies.

21\. Technologies to assess energy balance and control weight.

22\. Luminescent dyes to measure toxic metabolic intermediates in living
cells in real time.

23\. Novel use of information technology to enhance adherence to medical
regimens or promote translational research.

24\. Optimization of implantable defibrillator algorithms for arrhythmia
prediction, efficient intervention, device fault detection or early
failure detection.

25\. Methods to increase success of cardiac xeno-transplants.

26\. Methods to induce tolerance to cardiac allografts.

27\. Non-invasive methods to diagnose cardiac allograft vasculopathy.

28 Animal models of cerebrovascular disease.

29\. Novel techniques to study cerebrovascular disease.

C. Diagnostics and Treatment

1\. Non-invasive diagnostic test for salt sensitivity.

2\. Pharmacogenetics/Pharmacogenomics and personalized medicine.

3\. Vascular and renal tubular fluid dynamics, non-invasive assessment.

4\. Heart failure, early detection and treatment strategies.

5\. Anti-hypertensive drugs from natural and synthetic sources.

6\. Pro- and anti-angiogenic and vasculogenic genes, proteins and drugs.

7\. Development of viral and non-viral vectors for gene therapy for
cardiovascular diseases.

8\. Vaccines for the prevention or treatment of atherosclerosis.

D. Imaging

1\. Molecular imaging including imaging to detect gene expression.

2\. New medical imaging systems, enhancements and applications.

3\. Imaging characterizing vessel walls and lesions.

4\. Neuro-imaging in hypertension.

5\. Radiologic phantoms mimicking the human cardiovascular system.

6\. Specific agents for high resolution imaging of the human lymphatic
system.

[]{#__RefHeading___Toc124236976 .anchor}Lung Diseases

The NHLBI Division of Lung Diseases (DLD) maintains surveillance over
developments in pulmonary research and assesses the Nation\'s need for
research on the causes, prevention, diagnosis, and treatment of
pulmonary diseases. Also within the purview of the Division are:
technology development, application of research findings, and research
training and career development in pulmonary diseases. The DLD plans and
directs the research and training programs which encompass basic
research, applied research and development, clinical investigations,
clinical trials, and demonstration and education research. Two programs
comprise the Division of Lung Diseases: the Airway Biology and Disease
Program, and the Lung Biology and Disease Program.

*[Airway Biology and Disease Program]{.underline}*. Focuses on basic and
clinical research, education and training related to chronic obstructive
pulmonary diseases, asthma, cystic fibrosis, control of breathing,
bronchiolitis, respiratory neurobiology, sleep, and other adult airway
diseases.

*[Lung Biology and Disease Program]{.underline}*. Supports research,
education, and training programs in lung cell and vascular biology; lung
growth and development and pediatric lung disease; acute lung injury and
critical care medicine; interstitial lung diseases, including pulmonary
fibrosis and sarcoidosis; and AIDS and tuberculosis.

Research topics of interest to the Division of Lung Diseases include but
are not limited to the following:

A. Diagnostic Tools.

1\. Computer algorithms for reading and comparing chest radiographs and
scans (computed tomography, radioisotopes, etc.) using digitized images.

2\. Diagnose and treat respiratory abnormalities during sleep in
infants, children, and adults.

3\. Imaging techniques to monitor lung cell functions in vivo.

4\. Non-invasive measurement of blood gases, hemodynamics and
respiratory function in infants, in children, and in adults.

5\. Non-invasive methodologies for measuring airways inflammation in
asthma.

6\. Non-invasive markers of lung disease activity.

7\. Non-invasive methods to detect pulmonary thromboembolism,
hypertension, and edema.

8\. Probes to monitor peripheral tissue oxygenation in vivo.

9\. Use of ambulatory monitoring techniques to diagnose and manage
respiratory disorders of sleep.

10\. Computerized tomography to quantify and monitor pulmonary disease
processes.

11\. Novel methods for bioassays.

B. Information and Health Education Tools.

1\. Computer technologies to promote adoption and implementation of
asthma clinical practice guidelines in medical practice.

2\. Health education methodologies for patients, families, or
communities to prevent or cope with lung diseases or to reduce their
impact, especially among people with asthma who are minorities or living
in poverty.

3\. Improve smoking cessation programs.

4\. Information systems to coordinate patient management and monitoring
among patients and health care professionals.

5\. Interventions to reduce passive smoking in infants and children.

6\. Use of interactive and computer technology to teach self management
to asthma and chronic obstructive lung disease patients.

7\. Health education interventions on the recognition, management, or
prevention of problem sleepiness and sleep disorders for the public,
physicians, and other health care professionals.

C. Materials and Devices.

1\. Blood substitutes to improve gas exchange.

2\. Emergency, portable, and servo-controlled ventilatory support
devices.

3\. Improved aerosol delivery systems.

4\. Improved devices for continuous oxygen administration, including
airline travel.

5\. Improved extracorporeal or implantable devices for blood gas
exchange (artificial lung).

6\. New approaches and technologies that can be used to engineer
functional tissue, in vitro, for replacement or repair of damaged or
diseased lung tissue, in vivo.

7\. Personal exposure monitors for aeroallergens and other environmental
pollutants.

8\. Personal exposure monitors for measures of environmental exposures.

9\. Thrombo-resistant materials for extracorporeal or implantable
devices for blood gas exchange and for indwelling catheters.

D. Methods.

1\. "Clean" animal models for Pneumocystis carinii infections.

2\. Culture Pneumocystis carinii in vitro.

3\. Determine viability and enumeration of infectious Pneumocystis
carinii organisms.

4\. Development and standardization of in vitro systems for the study of
pulmonary epithelial (airway) cells and pulmonary endothelial (vascular)
cells.

5\. Identification of genes causing and modifying lung diseases.

6\. Identify and detect lung cell specific differentiation markers.

7\. Identify lung stem cell types.

8\. Identify species and strain differences of Pneumocystis carinii.

9\. Isolate, identify, and characterize cells found in pulmonary
granulomas.

10\. Methods to monitor levels of alertness or sleepiness continuously
over extended periods of time.

11\. Three-dimensional static, mathematical, cell culture models of
airways and alveoli to define parameters determining aeropollutant
absorption, deposition, and effects.

12\. Develop technologies and tools for use in genomic or proteomic
investigations of pulmonary diseases.

E. Treatments.

1\. Delivery of specific drugs (e.g., antioxidants, artificial
proteinase inhibitors, surfactant) and cell-based reagents to the lungs
for treatment of pulmonary and non-pulmonary diseases.

2\. Gene therapy for cystic fibrosis, alpha1antitrypsin deficiency,
primary pulmonary hypertension, and other inborn errors of metabolism
affecting the lungs.

3\. Improved aerosol delivery systems.

4\. Novel pharmacologic and gene therapy approaches for asthma, acute
lung injury, idiopathic pulmonary fibrosis, and bronchopulmonary
dysplasia.

5\. Novel pharmacologic approaches for treatment of sleep apnea.

6\. Pharmacological means of stimulating growth and repair of alveoli
and reparative or restorative elastogenesis in lungs suffering
emphysematous changes.

[]{#__RefHeading___Toc124236977 .anchor}Blood Diseases and Resources

The NHLBI Division of Blood Diseases and Resources (DBDR) plans and
directs research and research training and career development programs,
emphasizing non-malignant blood diseases and disorders of thrombosis and
hemostasis. The Division also has a major responsibility to improve the
adequacy and safety of the nation\'s blood supply and to advance the
study of stem cell biology and disease and novel cellular therapies. The
Division has three major programs, the Blood Diseases Program, the
Thrombosis and Hemostasis Program, and the Blood Resources Program.

*[Blood Diseases Program]{.underline}*. Supports research and training
for sickle cell disease, thalassemia, aplastic anemia and other red cell
disorders from basic research on globin genes to clinical management.

*[Thrombosis and Hemostatis Program.]{.underline}* Supports research and
training in occlusive disorders involved in deep vein thrombosis, in
cardiovascular diseases and stroke, and in bleeding disorders.

*[Blood Resources Program]{.underline}*. Supports research and training
in transfusion medicine, stem cell biology and disease, and clinical
cellular medicine.

Research topics of interest to the Division of Blood Diseases and
Resources include but are not limited to the following:

A. Animal models for blood diseases such as:

1\. Anemias including: sickle cell disease, thalassemia, Fanconi anemia,
Diamond Blackfan anemia, and other congenital anemias.

2\. Bleeding disorders including: hemophilia, von Willebrand disease,
and thrombocytopenia.

3\. Platelet diseases.

4\. Thrombosis and thrombolysis.

5\. Hereditary hemorrhagic telangiectasia.

6\. Paroxysmal nocturnal hemoglobinuria.

7\. Hemochromatosis.

8\. Myelodysplastic syndrome (MDS) and myeloproliferative disorders
(MPD).

9\. Hematologic malignancies.

B. Tools, reagents, and assays for hematologic research in mouse and
other animals.

1\. Nanotechnologies.

2\. Non-invasive approaches to analytes.

C. Assays and technologies for:

1\. Automated screening of therapeutic agents for blood diseases.

2\. Anti-thrombotic drug monitoring and thrombosis screening.

3\. Platelet functional tests.

4\. von Willebrand disease.

5\. Thrombotic Thrombocytopenia Purpura (TTP).

6\. Multiplexed system for hemostatic factors, cytokines, and
inflammatory agents.

7\. Iron overload.

8\. Blood-borne infectious agents transmitted by blood transfusion,
including agents of transmissible spongiform encephalopathies and
Creutzfeldt-Jakob Disease (CJD).

9\. Diagnosis of inherited blood disorders.

10\. Prolonging the in vivo lifetime of transfused red cells for
therapeutic uses.

11\. In vitro inactivation or removal of microorganisms from blood,
blood components, and plasma derivatives.

12\. Platelet storage methods that preserve biological efficacy.

13\. Synthesizing, screening, and evaluating the safety and efficacy of
therapeutic oxygen carriers.

14\. Synthesizing or purifying plasma proteins for therapeutic use.

15\. Measuring iron non-invasively.

16\. Non-invasive measurement of blood cell counts or other blood
components.

D. Drugs to Treat Hematologic Diseases and Cytopenic States

1\. Anti-coagulants.

2\. Anti-thrombotic agents.

3\. Anti-sickling agents or other pharmacologic approaches to sickle
cell disease.

4\. Fetal hemoglobin enhancing agents.

5\. Fibrinolytic and anti-fibrinolytic agents.

6\. Iron chelators.

7\. Replacement agents for hematologic factor deficiencies.

E. Cellular Therapies

1\. Expansion of cell populations.

2\. Production and standardization of immune-modulating cytokines or
monoclonal antibodies.

3\. Development of in vivo techniques to monitor survival, growth and
development of engrafted cells.

4\. Animal models for the demonstration of safety and efficacy of novel
cellular therapies.

F. Gene therapy vectors and delivery systems for the treatment of
hematologic genetic diseases.

G. Prothrombotic and hemorrhagic biomarkers and risk factors.

H. Computational models for blood diseases.

I. Bioinformatics to store and analyze genes, proteins, and biomarkers
for hemostasis.

J. Equipment and procedures for the collection, separation, processing,
preservation, storage, and distribution of blood and blood components.

K. Patient and physician health education programs to improve patient
management and to prevent or reduce the impact of blood diseases.

L. Public Health Education.

1\. Tutorials for community-based providers.

2\. Community health education programs in sickle cell disease, suitable
for use in faith-based organizations or other community settings.

M. Newborn Screening.

1\. Genetic counseling programs for families of infants with
hemoglobinopathies or trait.

2\. Innovative data or surveillance systems to track follow-up and
patient outcomes.

[]{#__RefHeading___Toc124236978 .anchor}Epidemiology and Clinical
Applications

The NHLBI Division of Epidemiology and Clinical Applications (DECA)
plans and directs programs in epidemiologic studies, clinical trials of
cardiovascular therapies, basic and applied behavioral research,
demonstration and education research, and projects for disease treatment
and prevention as well as health promotion, including large scale
clinical trials. The research supported by the Division provides
multidisciplinary approaches to heart and blood vessel, lung, and blood
diseases, and sleep disorders with a primary focus on cardiovascular
disease.

DECA comprises two programs, the Clinical Applications and Prevention
Program and the Epidemiology and Biometry Program, as well as the Office
of Biostatistics Research.

*[Clinical Applications and Prevention Program]{.underline}*. Supports
research into prevention and treatment of heart and vascular, pulmonary,
and blood diseases through activities such as efficacy and effectiveness
clinical trials, health promotion/disease prevention trials, community
intervention studies, nutrition research, and behavioral medicine
research.

*[Epidemiology and Biometry Program]{.underline}*. Supports and conducts
epidemiological studies of heart and vascular, lung, and blood diseases
in defined populations.

Research topics of interest to the Division of Epidemiology and Clinical
Applications include but are not limited to the following:

A. Clinical research/intervention studies designed to improve
cardiovascular disease outcomes.

1\. Approaches to facilitating adoption of evidence-based guidelines.

2\. Approaches to reducing clinical inertia in implementation of
evidence-based guidelines for control of cardiovascular risk factors,
including hypertension.

3\. Approaches to improving care of cardiovascular patients
transitioning from hospital to ambulatory or home care.

4\. Approaches to improving prevention and treatment of ischemic heart
disease (IHD), including prevention of recurring events and optimization
of functional capacity in patients with IHD.

B. Clinical trial methodologies.

C. Community education and demonstration research studies.

D. Studies of cardiovascular disease information, education, prevention,
and treatment systems for use in primary medical care and home care,
including care by family caregivers.

E. Interactive databases.

F. Measures of patient adherence/compliance.

G. Assessment of polypharmacy, particularly for the elderly.

H. Methods for:

1\. Lifestyle intervention, including matching patients to lifestyle,
intervention, or treatment.

2\. Health-care systems and outcomes research, including development of
new quality measures for evidence-based cardiovascular health care.

3\. Quantitative measurement systems for behavioral and lifestyle
variables, e.g., diet and physical activity.

I. Models of behavior modification and other approaches to behavior
change.

J. Interventions in patients to promote healthy lifestyles, adherence to
medications, and cardiac rehabilitation, including stress and exercise.

K. Treatment agents or strategies, including medications and devices.

L. Assay systems/techniques to measure patient responses to behavioral
or medical interventions.

M. Materials, equipment and software for enhanced medical Imaging
systems.

N. Methods for communication of research results.

O. Methods for collection, transmission, management and analysis of
clinical data.

P. Nutrition, physical activity, obesity, stress reduction and smoking
cessation interventions.

Q. Nutrition and physical activity measurement methods and devices.

R. Pharmaceutical development and toxicologic evaluation.

S. Population tracking mechanisms.

T. Psychosocial measurement instruments, especially in minority
populations, including chronic social stress, depression, and
discrimination.

U. Communication techniques for minority and low-income populations.

V. Prognostic assays.

W. Quality of life measurement and analytic methods.

X. Software for:

1\. Clinical trials.

2\. Epidemiology studies.

3\. Literature abstracting.

4\. Meta-analysis

5\. Statistical analysis.

6\. Shared clinical decision-making.

7\. Monitoring and providing feedback to patients and providers in
clinical care settings.

8\. Analysis of context-dependent genetic effects.

9\. Longitudinal data analysis

10\. Microarray data analysis.

11\. Automated systems for genotyping quality control and error
checking.

Y. Screening, assessment, and tracking tools including biomarkers for
hypertension, coronary heart disease, heart failure and other
cardiovascular risk factors and diseases.

Z. Survey questionnaires.

AA. Training techniques and modules.

BB. Interactive web-based programs for health promotion.

CC\. Computerized systems to support evidence-based clinical practice in
prevention and treatment of hypertension, coronary heart disease, heart
failure and other cardiovascular risk factors and diseases.

DD. Biomarkers for long term exposure to environmental factors including
diet, physical activity, smoking, alcohol, and contaminants.

EE. Measures of gene expression in individuals.

FF. Cell immortalization, storage and distribution service.

GG. Standardized assays of glycosolated hemoglobin.

HH. Better measures of impaired glucose tolerance.

II\. Simplified measures of sleep useful for population based studies.

JJ. Better measures of heart failure, including diastolic heart failure.

KK. Measures of small vessel disease.

[]{#__RefHeading___Toc124236979 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

*[Heart and Vascular Diseases]{.underline}*

J. Timothy Baldwin, Ph.D.

Division of Heart and Vascular Diseases

National Heart, Lung and Blood Institute

6701 Rockledge Drive, Room 9150

Bethesda, MD 20892-9150

\(301\) 435-0513, Fax: (310) 480-1335

Email: <baldwint@nhlbi.nih.gov>

Pothur R. Srinivas, Ph.D.

Division of Heart and Vascular Diseases

National Heart, Lung and Blood Institute

6701 Rockledge Drive, Room 10188

Bethesda, MD 20892-7940

\(301\) 435-0550, Fax: (310) 480-2858

Email: <srinivap@nhlbi.nih.gov>

Bishow Adhikari, Ph.D.

Division of Heart and Vascular Diseases

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 9161

Bethesda, MD 20892-9150

Phone: 301-435-0513

Fax: (301) 435-1335

Email: <adikarb@nhlbi.nih.gov>

*[Lung Diseases]{.underline}*

Ms. Ann Rothgeb

Division of Lung Diseases

6701 Rockledge Drive, Room 10124

Bethesda, MD 20892-7952

\(301\) 435-0202, Fax: (301) 480-3557

Email: <ar31t@nih.gov>

*[Blood Diseases and Resources]{.underline}*

Ms. Phyllis Mitchell

Division of Blood Diseases and Blood Resources

6701 Rockledge Drive, Room 10166

Bethesda, MD 20892-7950

\(301\) 435-0481, Fax: (301) 480-1060

Email: <pm154p@nih.gov>

*[Epidemiology and Clinical Applications]{.underline}*

Dr. Paula Einhorn

Division of Epidemiology and Clinical Applications

6701 Rockledge Drive, Room 8111

Bethesda, MD 20892-7938

\(301\) 435-0563, Fax: (301) 480-1773

Email: <einhornp@nhlbi.nih.gov>

For program information, contact:

Ms. Susan Pucie

Division of Blood Diseases and Resources

6701 Rockledge Dr

Two Rockledge Ctr, Room 10166

Bethesda, MD 20892-7950

\(301\) 435-0079, Fax: (301) 480-0867

Email: <sp34j@nih.gov>

For administrative and business management questions, contact:

Ms. Suzanne White

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 7160

Bethesda, MD 20892-7926

\(301\) 435-0144, Fax: (301) 480-3310

Email: <sw52h@nih.gov>

[]{#__RefHeading___Toc124236980 .anchor}National Human Genome Research
Institute (NHGRI)

The scientific community now has available to it an extensive and large
data set of genome resources and tools. The finished genomic sequences
of many model organisms, the draft genomic sequences of human, mouse and
rat, and the finished genomic sequences of a number of human chromosomes
have been published. In addition, many other tools and technologies that
allow these resources to be exploited are available, including
microarray technologies and thousands of sequenced full-length cDNAs
generated by the Mammalian Gene Collection. These resources can be used
in creative and powerful ways to facilitate our understanding of human
biology.

With the completion of many of the original goals of the Human Genome
Program, the NHGRI unveiled its vision for the future of genomics in
April 2003 (<http://www.nhgri.nih.gov/11006873>). The vision has three
major themes- (1) genomics to biology; (2) genomics to health; and (3)
genomics to society. There are also six cross-cutting areas which
support the vision: technology development, computational biology,
resources, training, education, and ethical, legal and social issues.

The success of the Human Genome Project has been due in large part to
the development of improved technologies, strategies and methods that
can be applied on a genome-wide scale in a cost-effective manner. As the
vision of genomics expands, the development of new and improved
technologies will be even more important in helping to accomplish the
NHGRI's new research goals. Therefore, the NHGRI solicits SBIR/STTR
grant applications in the areas listed below. Innovative and new
approaches in other areas not listed in the major topics below, but that
are relevant to genomics, will also be seriously considered.

[]{#__RefHeading___Toc124236981 .anchor}DNA Sequencing

The ultimate goal of the DNA sequencing technology program is to develop
technologies that can generate accurate DNA sequence from whole genomes
in a short time and at a very low cost (e.g., \$1000 for a
mammalian-sized genome). To achieve that, more near-term goals include
the development of innovative, cost-effective technologies and
strategies to (1) reduce the cost, increase the throughput, or improve
the accuracy of large-scale DNA sequencing of complex genomes; (2)
obtain DNA sequence in the gaps that are left by current sequencing
methods or improve the efficiency of sequencing in genomic regions that
have proved difficult to sequence due to limitations in available
cloning and sequencing technology; (3) determine sequence in regions of
difference between closely-related organisms; (4) determine the sequence
of any particular region of a genome and its syntenic regions from
genomes of several other species; (5) rapidly and cost-effectively
determine the sequence of one or more large (megabase) genomic regions
from many individuals of a single species (e.g., human) for mutation
detection; and (6) rapidly and cost-effectively resequence entire
genomes to detect polymorphism. Instrumentation and methods development
from feasibility through prototype development and introduction into
production are supported. Any applicable technology approach is
welcomed; micro- and nanotechnology approaches are particularly
encouraged.

[]{#__RefHeading___Toc124236982 .anchor}Human Genome Sequence Variation

Development of new or improved methods and analytic tools for: (1) the
large-scale identification, scoring, and interpretation of DNA sequence
variants; (2) the identification of haplotypes and generation of
haplotype maps; and (3) facilitation of studies relating genetic
variation to association with disease, to gene mapping, and to an
understanding of chromosomal and population processes.

[]{#__RefHeading___Toc124236983 .anchor}Comparative Genomics

Improvement in the technology for generating clone libraries useful for
genomic analysis with DNA inserts that are stable, free of artifacts,
and faithfully representative of genomic DNA from complex organisms.
Also of high priority is the development of technology to generate
physical maps efficiently and rapidly.

[]{#__RefHeading___Toc124236984 .anchor}Functional Genomics

Development of new or improved technologies for large-scale or
genome-wide approaches relating to: (1) gene discovery, full-length cDNA
synthesis, or gene expression analysis; (2) improved or new technologies
that are more efficient for isolating cDNAs for mRNAs that are rare or
long (\>4kb), or both; (3) analysis of the products of gene expression
(e.g., proteins, metabolites), their identification in biological
samples, their modifications, their interactions; (4) functional
analyses of non-coding sequences; (5) generation and detection of
mutations; and (6) innovative instrumentation used in screening for
chemical modifiers of function, i.e., chemical genomics. Micro- and
nanotechnology approaches are particularly encouraged.

[]{#__RefHeading___Toc124236985 .anchor}Bioinformatics and Computational
Biology

Development of new or improved tools for: (1) obtaining, representing,
analyzing and archiving data; (2) assembling sequence data; (3)
extracting information from comparative genomic sequences; (4) improving
databases, in the areas of DNA sequence, gene mapping, complex trait
analysis, genetic variation and homology, and functional genomics; (5)
editing and implementing controlled vocabularies for genomic and
phenotypic information; and (6) integrating genomic and genetic data for
the purpose of identifying and modeling genetic pathways and networks.

[]{#__RefHeading___Toc124236986 .anchor}Bioinformatics Education

Development of new educational curricula and tools to facilitate the
teaching of (1) bioinformatics to high school and college students and
(2) genomics, genetics, and bioinformatics approaches to understanding
human biology and disease to physicians.

[]{#__RefHeading___Toc124236987 .anchor}Ethical, Legal and Social
Implications (ELSI) of Genomics and Genetics Research

Examination of issues surrounding the commercialization of genetic
technologies, including issues relating to patenting, licensing, and
other intellectual property concerns.

[]{#__RefHeading___Toc124236988 .anchor}Other Research Topic(s) Within
the Mission of the Institute

Individuals interested in any of the above listed areas are encouraged
to contact the NHGRI staff listed below. For more specific information
about areas of interest to the NHGRI, please visit our home page at
<http://www.genome.gov/Grants/>.

For additional information on research topics, contact:

*[All Research Topics Except ELSI]{.underline}*

Bettie J. Graham, Ph.D.

National Human Genome Research Institute

\(301\) 496-7531, Fax: (301) 480-2770

Email: <bg30t@nih.gov>

*[ELSI Research Topics]{.underline}*

Jean E. McEwen, J.D., Ph.D.

National Human Genome Research Institute

\(301\) 402-4997, Fax: (301) 402-1950

Email: <jm522n@nih.gov>

For administrative and business management questions, contact:

Ms. Cheryl Chick

Chief, Grants Management Officer

National Human Genome Research Institute

\(301\) 435-7858, Fax: (301) 402-1951

Email: <ChickC@mail.nih.gov>

[]{#__RefHeading___Toc124236989 .anchor}National Institute of Mental
Health (NIMH)

The mission of the National Institute of Mental Health (NIMH) is to
diminish the burden of mental illness through research. To achieve this
goal, the NIMH funds basic research, translational research, clinical
studies, and services delivery research concerning any aspect of
behavioral and mental disorders (including HIV prevention and neuro-AIDS
research). Ultimately, this research will lead to greater understanding,
better treatment and rehabilitation or prevention of mental disorders.
The NIMH is also concerned with the speedy dissemination and use of this
knowledge through scientific communications and public education, and in
its more effective implementation in practice and service delivery
systems. There is a general need to develop reliable and inexpensive
products, that can serve these needs.

For additional information about areas of interest to the NIMH, please
visit our home page at
[http://www.nimh.nih.gov](http://www.nimh.nih.gov/).

[]{#__RefHeading___Toc124236990 .anchor}Phase II Competing Renewal
Awards

(See <http://grants.nih.gov/grants/guide/pa-files/PA-06-079.html>.)

The NIMH will accept Phase II SBIR Competing Renewal grant applications
to continue the process of developing technologies that ultimately
require federal regulatory approval. Such technologies include, but are
not limited to, pharmacologic agents and drugs, biological products,
devices, vaccines, etc., related to the mission of the NIMH. This
renewal grant should allow small businesses to get to a stage where
interest and investment by third parties is more likely. Budgets up to
\$800,000 total costs per year and time periods up to 3 years may be
requested for this Phase II Competing Renewal opportunity.

Please contact your Program Director or Dr. Margaret Grabb (contact
information provided below) before beginning the process of putting an
application together. In addition, prospective applicants are strongly
encouraged to submit to the program contact a letter of intent that
includes the following information:

-   Descriptive title of the proposed research

-   Name, address, and telephone number of the Principal Investigator

-   Names of other key personnel

-   Participating institutions

-   Funding Opportunity Announcement Number (e.g., PA-06-XXX)

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 NIH staff to estimate the potential review
workload and plan the review. It is expected that only a portion of NIMH
SBIR Phase II awards will be eligible for a Competing Renewal grant.

The following examples would make appropriate topics for proposed NIMH
SBIR Phase II Competing Renewal projects. These are meant for
illustrative purposes only and are not exclusive of other appropriate
activities:

-   Preclinical studies, including pharmacology and toxicology, beyond
    those conducted under the Phase I (R43) and initial Phase II (R44)
    grants. Some in vivo or in vitro studies would be expected to have
    been carried out in Phase I or the initial Phase II grant.

-   Completion of studies as required by the Food and Drug
    Administration (FDA) for Investigational New Drug (IND) or
    Radioactive Drug Research Committee (RDRC) application.

-   Studies in normal healthy volunteers to determine a drug's safety
    profile, metabolism, etc.

-   Clinical studies in patient/disease population to assess the drug's
    effectiveness.

-   Assessment of devices with regard to performance standards related
    to the FDA approval process.

-   Safety and effectiveness studies of novel medical devices.

-   Evaluation of novel imaging approaches for diagnostic purposes.

-   Clinical studies in support of Pre-Market Approval for
    biomarkers/medical devices by the FDA.

Direct your questions about scientific/research issues to:

Margaret Grabb, Ph.D.

Division of Neuroscience and Basic Behavioral Science

National Institute of Mental Health

6001 Executive Boulevard, Room 7201, MSC 9645

Bethesda, MD 20892-9645

Rockville, MD 20852 (for express/courier service)

Telephone: (301) 443-3563

FAX: (301) 443-1731

Email: <mgrabb@mail.nih.gov>

[]{#__RefHeading___Toc124236991 .anchor}Division of Neuroscience and
Basic Behavioral Science

Through research in neuroscience and basic behavioral science we can
gain an understanding of the fundamental mechanisms underlying thought,
emotion, and behavior and an understanding of what goes wrong in the
brain in mental illness. Research sponsored by the Division of
Neuroscience and Basic Behavioral Science covers a broad range of
neuroscience topics: from both experimental and theoretical approaches,
from molecules to whole brains to populations of individuals, from
single cell organisms to humans, from across the entire lifespan, and
from states of health and disease. This division also supports research
on the basic behavioral, psychological, and social processes that
underlie normal behavioral functioning. The topics listed below reflect
the NIMH interest in technologies related to this broad range, but
should not be considered a complete list. Prospective applicants are
strongly encouraged to contact Dr. Margaret Grabb (listed below) with
questions about the relevance of their interests to the mission of this
division.

A. ***[Cutting-Edge Technologies for Neuroscience
Research.]{.underline}*** Most of the research topics listed after this
one are posed from the Division\'s neuroscience and basic behavioral
science mission-oriented perspective, however, the technologies that
might be developed to address those mission goals might be quite
fundamental. Prospective applicants familiar with such technologies, but
not familiar with the mission-related use of these technologies, are
strongly encouraged to contact Dr. Margaret Grabb (listed below) for
assistance in bridging this gap between their technical knowledge and
knowledge of the neuroscience-related mission of NIMH. Technologies and
approaches that might be used in products relevant to this mission
include, but are not limited to:

1\. *[Caged Molecules]{.underline}*. These chemical entities could be
activated, or could release an active agent, when specified bonds are
broken by chemical, biochemical, photic, or other means. Among other
uses, such molecules could be used to indicate biochemical or
physiological processes or to deliver pharmacologic substances to highly
localized brain regions.

2\. *[Genetically Engineered Proteins]{.underline}*. Such proteins could
be put to any number of uses, including to express a fluorophore or
chromophore at the occurrence of specific biochemical processes to
report the time and location of such processes in brain tissue.

3\. *[Inducible Gene Expression]{.underline}*. Methods to turn on or off
expression of particular genes in transgenic animals on the basis of
time in the lifespan, location in the brain, or other factors. Such a
capability would significantly advance basic brain research, and would
have important implications for treatment and therapy of mental illness.

4\. *[Combinatorial Approaches]{.underline}*. These are high-through-put
approaches that can be used to screen and synthesize molecules that
affect brain cells.

5\. *[Biocompatible Biomaterials]{.underline}*. Such research and
development relates to the chronic use of electrodes and other probes
used in brain research, as well as implanted drug delivery devices.

6\. *[Nanotechnologies]{.underline}*. This emerging area of technology
presents a wide range of opportunities for brain research, from the
fabrication of probes to monitor brain physiology to novel means of
delivering drugs and other substances.

7\. *[Informatics Tools]{.underline}*. Such technologies allow brain
scientists, clinicians and theorists to make better sense and use of
their data. These tools and approaches include those to acquire, store,
visualize, analyze, integrate, synthesize and share data, including
those for electronic collaboration.

8\. *[Simulation Technologies]{.underline}*. Computer-based simulations
of parts of neurons, neurons, circuits or even organisms to observe the
manner in which these components interact. For example, simulations of
individual organisms with constellations of particular traits that vary
across individuals would allow analysis of their interactions and their
impact on the population as a whole.

9\. *[Mathematical, Statistical and Computer Algorithms]{.underline}*.
Such algorithms could be used to analyze large and/or complex data sets.
Examples of these data sets include those derived from multiple,
single-unit recording studies and functional imaging studies. Among
other applications, these could be used to segment images (obtained from
electron or light microscopes, or from volumetric imaging instruments
such as confocal microscopes and magnetic resonance imagers), filter
noise, visualize data or search vast data sets for specified patterns or
data (e.g., use of pattern recognition algorithms to search time series
data sets obtained from electrophysiological recording of neural
activity, or video data obtained from behavioral analysis of genetically
altered animals). Improved techniques for path analysis when examining
functional imaging datasets would also be of interest.

10\. *[Telemetry]{.underline}*. Transferring data from one point to
another is important for neuroscientists monitoring the physiological
signals from the brain. Telemetry, even over relatively short distances
(from a few millimeters to a few meters), could, for example, provide a
means to obtain data from awake, behaving animals without interfering
with the behavior of interest.

11\. *[Biosensors]{.underline}*. Neurons communicate with each other
through thousands of different chemical substances; internally,
molecular pathways direct the function of the neuron. Sensors of high
specificity and sensitivity for such substances would provide
neuroscientists with important new ways to study the brain.

B. ***[Instrumentation for Basic Neuroscience Research.]{.underline}***
Modern equipment that uses the most recent technological advances is
needed in neuroscience research so that neural substrates of mental
illness can be identified and localized. The NIMH is interested in
supporting research and development of new or improved approaches
relevant to, but not limited to, the following:

1\. *[Neurophysiology]{.underline}*. Microelectrodes, smart
nanoscaffolds, macroelectrodes, biocompatible coatings, interfaces to
electronics, software for data analysis, visualization, etc.

2\. *[Cell Sorting]{.underline}*. Based on cell size, type, function,
etc.

3\. *[In Vivo Electrochemical Voltammetry]{.underline}*. More sensitive
and selective electrodes, software for data analysis, etc.

4\. *[High Performance Liquid Chromatography]{.underline}*. Improved
reliability, specificity, sensitivity, etc.

5\. *[Technology to support Multiple Unit Recording Electrode
Arrays]{.underline}*. Both recording techniques and analysis techniques.

6\. *[Physiological and Behavioral Monitoring]{.underline}*.
Temperature, activity, sleep duration, neuronal activity, EEG activity,
EKG, pulse rate, recording, capture and analysis of multiple single unit
activity from microelectrodes.

7\. *[Associated Software]{.underline}*.

C. ***[Macroscopic Neuroimaging.]{.underline}*** Modern technologies
allow for the observation of the structure and function of the intact
brain. This capability has the potential to greatly advance
understanding of the brain in both health and disease, and across the
lifespan. NIMH is interested in advancing this area of technology
through enhancing current tools and approaches, as well as developing
entirely new ways to image the brain. All modalities are of interest,
including, but not limited to: magnetic resonance imaging (MRI) or
spectroscopy, positron emission tomography (PET), optical imaging or
spectroscopy, single photon emission computed tomography,
magnetoencephalography (MEG), diffusion tensor imaging (DTI), etc. While
not an imaging technique itself, transcranial magnetic stimulation (TMS)
is an associated, important technology. Due to its greatly increased use
in recent years, technologies specifically focused on improving the
utility of fMRI techniques are of particular interest.

1\. Innovative agents and/or technologies to visualize brain
connectivity in situ with minimal invasion.

2\. Improvement in the techniques, the design and construction of
devices for non-invasive imaging for any modality, for example,
improving spatial resolution, quantitative accuracy, signal-to-noise
ratio, and electronics.

3\. Development and enhancement of non-invasive imaging techniques for
evaluating alterations in brain physiology produced by drugs. These
would include techniques for monitoring changes in regional blood flow;
concentrations of tissue metabolites; and the distribution and activity
of receptors.

4\. Synthesis, or isolation from natural products, of highly selective
receptor ligands or indicators of neurochemical processes, which would
be labeled for imaging by one or more particular modality.

5\. New approaches in radiochemistry that will permit more exact
identification of the chemical changes associated with behavioral states
(e.g., sleep or arousal) or mental illness as observed with any
particular neuroimaging modality.

6\. Synthesis of molecules containing stable, rarely occurring isotopes
designed to be detected by non-invasive imaging techniques (e.g.,
fluorine-containing molecules, carbon-13 labeled substrates).

7\. Methods and associated products for quantitation of imaging data
including new statistical approaches for evaluating the data.

8\. Methods to integrate routines for greater and more precise computer
enhancement of the images, and for combining or overlaying images
obtained from multiple modalities.

9\. Software needed for the precise quantitation of data obtained from
these imaging techniques with emphasis on the reliable definition of
discrete, anatomically distinct areas within the brain.

10\. Novel agents or other tools to increase the ability to correlate
features of MRI images with histological features (e.g.,
cytoarchitecture or chemoarchitecture) both identified and those yet to
be identified.

11\. Generation of physiologic measurements from images of regional
radioactivity generated during PET, especially for the study of brain
neurotransmitter/ neuroreceptor systems.

12\. Novel approaches to visualizing data obtained in neuroimaging, such
as the computational "unfolding" of three-dimensional images of cerebral
cortex.

13\. Improved methods for pediatric brain imaging. These would include:
software and database products, equipment for creating a
"child-friendly" environment and for the behavioral training of children
and impaired subjects for cooperation and motion reduction during
neuroimaging procedures.

14\. Combining of different imaging technologies (e.g., ERPs and fMRI;
MEG and fMRI; MEG and EEG, etc).

15\. Development of equipment, software and other tools for recording
and quantifying eye movements, motion, and autonomic reactivity during
scanning, applicable to all ages (including young children) particularly
in the MRI environment.

16\. Methods for relating changes in brain morphology and metabolism
associated with age, particularly infancy through adolescence, to
changes in hemodynamic responses to neural activity and fMRI signals.

17\. Improvements in TMS techniques that will allow for greater
specificity in the sites of stimulation and greater control over the
effects of the stimulation.

D. ***[Microscopic Neuroimaging.]{.underline}*** The morphology of
individual neurons and the distribution of subcellular components within
them, are key to understanding the manner in which these cells function.
Advances in the development of agents indicating neuronal structure and
function that can be visualized microscopically are important to the
NIMH\'s interest in brain research. This includes enhancements of
current agents and ligands to be imaged (agents indicating specific
biochemical processes or structures, etc.); development of novel agents
and ligands; software to assist interaction with the data; and other
related technologies and methods. Examples would include, but not be
limited to:

1\. Software and hardware for analyzing image data obtained by
microscopes, including tools to automatically or semi-automatically.
Identify particular profiles (e.g., labeled cell bodies), segment
images, reconstruct images into three dimensional representations,
perform unbiased counting and measuring, etc.

2\. Synthesis and testing of novel or improved probes for microimaging
the nervous system.

E. ***[Molecular and Cellular Neurobiology and
Neurochemistry.]{.underline}*** Manipulating and studying basic
molecular, cellular and chemical processes has led to insight to
understanding brain function, and has provided the foundation on which
pharmacological interventions have been developed for the treatment of
mental illness. NIMH is interested in supporting a wide range of new
techniques and tools related to this area. These include, but are not
limited to:

1\. New low-cost techniques for hybridoma production of monoclonal
antibodies specific for "neural antigens" (e.g., neurotransmitters,
small peptides, neurotransmitter receptors).

2\. Innovative methods for establishing a "monoclonal bank" (frozen
cells) for each of the cell lines as a permanent, widely available,
reliable, and low cost source of monoclonal antibodies for research on
the nervous system.

3\. Labeled antibodies or other agents that will readily identify
receptors for which there are no ligands (orphan receptors) and which
have low densities in the brain.

4\. Automated methods for quantitating the low levels of bound ligands
for quantitating receptors that are sparsely scattered in the brain.

5\. New cell lines that express each of the known neurotransmitter
receptors so that each cell line will be homogeneous for one receptor.

6\. New cell lines that express each of the above receptors linked to
some metabolic function and/or second messenger so that the functional
consequences of receptor occupancy can be detected.

7\. High volume, inexpensive assay methods for measuring both receptor
occupancy and cellular response for each of the receptor types.

8\. Develop cell culture models for neurons, including methods of
purifying homogeneous populations of non-transformed cells by, for
example, developing markers to identify neuronal cell types for use in
characterizing cell-type-specific signaling pathways which may be useful
in tracking the effects of various drugs.

9\. Develop techniques for either activating or deactivating specific
ion channels, receptors and signal transduction pathways.

10\. Develop dynamic biochemical and imaging assays that allow
measurement of variables now obtained only through electrophysiological
techniques.

11\. New approaches to study the multiple functions of particular
proteins.

12\. Tools to study post-translational changes in proteins in specified
tissue compartments.

13\. Technologies to study functional entities within cells (e.g., green
fluorescent protein approaches).

14\. Tools and approaches to study coordinate changes in genes and their
functional relationship to phenotypes, including phenotypes associated
with specific brain disorders.

15\. New ways to assess quantitatively transcription of genes in real
time in a manner that is minimally injurious to cells (e.g.,
non-permeabilizing approaches).

16\. Novel tools and approaches to study protein-protein interactions,
especially those with phosphoproteins. Further develop methods and
reagents for studying the structures of membrane proteins at atomic
resolution. Membrane protein systems that are of particular interest to
NIMH include proteins involved in normal function and pathology of cells
(neurons and glia) in the central and peripheral nervous system.

17\. Develop novel techniques for isolating and identifying the
structure of brain-derived membrane proteins.

F. ***[Genetic and Transgenic Technology.]{.underline}*** Advances in
genetic and transgenic technologies offer many opportunities to probe
fundamental questions about the brain, behavior and pathology. NIMH is
broadly interested in these areas; some examples of topics relevant to
the mission of this Institute include, but are not limited to:

1\. Methods to perform site-directed mutagenesis in cell lines for the
study of membrane proteins such as ion channels and neurotransmitter
receptors.

2\. Development of gene "knockout" or "knockin" animals using such
approaches as homologous recombination targeting genes important in
neurotransmission, development, and tropic interactions as well as in
generating behavioral models of disease.

3\. New methods to delete or alter targeted genes in the preparation of
transgenic animals including methods that increase or decrease gene
expression.

4\. Development of new techniques and apparatus for delivery of
antisense oligonucleotides into cells and specific tissue such as the
brain.

5\. Develop standardized behavioral tests to assess the gene knockouts
and/or gene "knockins" affecting neurotransmission.

6\. New approaches for cell-specific, tissue-specific, age-specific,
transient gene activation and/or inactivation.

7\. Innovative technologies to study gene function and expression.

8\. Development of embryonic stem (ES) cell lines from rodent strains
(rats and mice) of relevance to behavioral research.

9\. Development of technologies and approaches to facilitate the
collection and distribution of ES cell lines containing mutations of
potential relevance to behavioral research.

10\. Develop methods for long-term storage of transgenic germ cell
lines.

11\. Develop technologies and approaches to aid in the renewal of
founder colonies of transgenic mice from repositories of transgenic germ
cell lines.

12\. Develop databases on neurobiological transgenic animals produced to
date, including information such as the origin of the transgenic animal,
key features of the biological and behavioral mutant, availability and
location of germ cell lines, and existence of breeding colonies.

13\. Develop gene transfer technologies such as viral vectors to produce
long-term, stable gene expression in the brain.

G. ***[Neuroimmunology.]{.underline}*** Research on the interplay
between the brain, neuroendocrine system, and, immune system has
revealed important links between these major homeostatic system
components. Examples of NIMH-relevant topics in this area include, but
are not limited to:

1\. Development of new tools to explore the special properties of the
blood-brain barrier responsible for the selective delivery or retention
of cytokines, immune cells, and drugs affecting immune activity in the
brain.

2\. Development of assays for identifying potential autoimmune
components of psychiatric disorders (other than the usual screening for
"markers").

3\. Identification of critical molecules, processes, and pathways
mediating signals from the peripheral immune system to the brain.

4\. Development of novel cytokine ligands and antagonists.

H. ***[Pharmacology.]{.underline}*** Pharmacological intervention
represents a major force in the treatment of mental illness, and NIMH is
interested in supporting research and development in this area. Relevant
topics include, but are not limited to:

1\. New chemical entities with high, selective affinities for each of
the receptors in the brain.

2\. Methods to evaluate old and new chemical entities (including complex
mixtures of crude extracts from natural products) for possible
therapeutic usefulness using "in vitro" and "in vivo" assays and model
systems.

3\. Methods for extraction, fractionalization, and isolation of active
compounds from natural products. Water-soluble compounds are of
particular interest due to the difficulty of the procedures.

4\. Computer algorithms that model receptors to evaluate theoretical
permutations of known molecules to find the molecule with the maximum
probability of having the highest affinity for a specific receptor as
well as those that have the potential for the most desirable "on" and
"off" rates.

5\. Computer models of the blood brain barrier and evaluate potential
and actual drug molecules for their ability to cross or penetrate this
barrier.

6\. Strategies for evaluating pharmacological agents (e.g., animal
behavioral testing, computer simulation) on cognitive function.

7\. Behavioral "models" similar in animals and humans; behavioral
pharmacological effects that may serve as "surrogate" markers in humans.

8\. Development of novel drug delivery systems.

9\. Tools for Drug Development including neuroimaging (e.g.,
radiolabeled compounds) and development of animal models.

10\. Pharmacological profiling (in vitro and in vivo) for potential
therapeutic drugs.

11\. Methods for evaluation of long-term effects of psychotropic drug
administration in animal models or human subjects. If clinical
populations are being tested, the technology would be appropriate for
either the Division of Pediatric Translational Research (DPTR) or the
Division of Adult Translation Research (DATR) at NIMH.

12\. Improving existing, and developing new, vectors for delivery of
genes to the brain.

13\. Development of novel therapeutic approaches based on drug-induced
changes in gene promoter activity.

14\. Development of novel high throughput screening (HTS) assays for
drug development. Examples include, but are not limited to, in vitro
functional assays, toxicology screens, blood-brain barrier permeability
assays, and behavioral assays.

15\. Development of novel molecular targets for drug development to
treat mental illnesses.

I. ***[Tract Tracing Methods and Tools.]{.underline}*** Little is known
about the details of the connectivity of the human nervous system,
because the best tract tracing techniques are invasive and require the
deposit of substances in vivo. Methods that would be applicable to
post-mortem tissue would allow significant progress in connectional
studies of human tissue, as well as non-human tissue, particularly with
regard to the development of connections and the connections of
structures not easily accessed in vivo.

J. ***[Basic Behavioral Science.]{.underline}*** It is important to
develop reliable methods that can correctly identify the normal and
abnormal components of cognitive, emotional, and psychosocial behavior
in human development. Computer-based methods of accomplishing this are
also needed to increase the accessibility and reliability of information
made available to the research community.

1\. *[Methodological Research and Development]{.underline}*. There is a
need to devise new ways of data collection, analysis, management and
dissemination. The goal is to encourage research that will improve the
quality and scientific power of data collected in the behavioral and
social sciences, relevant to the mission of NIMH. Research that
addresses methodology and measurement issues in diverse populations,
issues in studying sensitive behaviors, issues of ethics in research,
issues related to confidential data and the protection of research
subjects, and issues in developing multidisciplinary, multimethod, and
multilevel approaches to behavioral and social science research is
particularly encouraged.

a\. Improve or create new video devices to monitor animal and human
behavior and ease analysis of behavior.

b\. Computer software to ease analysis of behavior monitored by video or
telemetry systems.

c\. Innovative computer-based observation techniques, and computer
software and hardware that allow on-line methods for characterization of
a person's behavioral or physiological responses to group interactions.

d\. Causal modeling methodology as applied to correlational longitudinal
data sets.

e\. A data translation and communication package for collecting,
archiving, and making available existing longitudinal behavioral sets to
the scientific community for secondary or meta-analyses.

f\. Flexible user-friendly software for control of timed, multi-modal
stimulus presentation and response collection for experiments on
perception and cognition.

g\. There is a need for the development of hardware for time-stamped
diary collecting instruments for use in actigraph studies of circadian
rhythms in adults, children, and adolescents. Diaries are critical for
the evaluation of activity data, and time-stamped diary collecting
instruments can ensure investigators of receiving reliable information.

h\. Web-based software tools for designing, updating, sharing, linking,
and searching databases containing detailed information about the
methodology and results of behavioral science studies.

2\. Diagnosis and assessment of emotional and psychological states such
as automated methods to detect specific emotional states using
behavioral and autonomic indicators.

a\. *[Physiological Monitoring]{.underline}*. Techniques and equipment
for continuous monitoring of physiological data (e.g., temperature,
activity, sleep duration, EEG activity, ECG, pulse rate). Computer
programs that can record, catalog, categorize and identify
interrelationships between several of the above measures. Appropriate
areas for behavioral clinical research would include developing:

i\. Reliable non-invasive means of chronic monitoring of physical
activity and physiological measures such as body temperature.

ii\. New techniques for electrophysiological images from the level of
the single cell and surface EEG recording on the scalp.

iii\. Small, portable automated systems to monitor eye function (e.g.,
pupil size, accommodation) and eye movements.

iv\. Software and hardware analyzing and providing experimental control
over multiple single unit recordings, on-line and in real-time.

b\. *[Measurements of Infant Development Using Physiological and
Behavioral Measures]{.underline}*.

i\. Psychophysiological measures to evaluate infants during the first
six months of life.

ii\. Miniaturized non-invasive instruments to record psychophysiological
data (e.g., heart and respiration rate, galvanic skin response, and
defensive motor behavior).

iii\. Telemetry capability for non-invasive devices so that infants can
be monitored for prolonged periods without interfering with their
behavior.

iv\. Computer programs and inexpensive computers that will collect,
analyze and identify recurring patterns in the psychophysiological
measure(s) of interest.

c\. *[Behavior Monitoring and Analysis]{.underline}*.

K. ***[Educational Tools.]{.underline}*** Neuroscience and basic
behavioral science are compelling areas of science that not only touch
upon a diverse array of disciplines, but also provide insights to the
essence of what it is to be human. Products aimed at teaching the
substance of these fields to students of all ages would be useful in
disseminating this information and these insights. Examples include, but
are not limited to: software and other interactive media used to convey
fundamental concepts about the brain to children; computer simulations
of neuroscience experiments; updateable media that presents
state-of-the-art information on particular topics for use by experts;
website or other online, interactive electronic vehicle to allow for
sharing of information about the brain and its functions, including
technologies for holding interactive research conferences related to
basic behavioral sciences, basic neuroscience, or clinical neuroscience.

L. ***[Neuroinformatics.]{.underline}*** Data generated by brain
research are diverse, vast, and complex. The diversity of data is due to
the fact that neuroscience data are obtained from: theoretical,
experimental and clinical approaches; from levels of biological
organization that span molecules to populations of individuals and from
single-cell organisms to humans; and from states of health, disease, and
models of disease. The quantity of data in brain research is the result
of tens of thousands of neuroscience laboratories working around the
world. The complexity of data reflects the high level of
interconnectedness of the data, and their high dimensionality.
Neuroinformatics is a new area of science that draws upon neuroscience,
information science, computer science, statistics, applied mathematics,
and a variety of engineering fields to develop tools that will let
neuroscientists make better sense and use of their data. These tools
include software and hardware for digital data acquisition,
visualization, analysis, integration, and sharing (e.g., through tools
for electronic scientific collaboration). Such tools can address data of
any type or from any area of neuroscience; examples include, but are not
limited to:

1\. Databases, querying approaches, and information retrieval tools for
neuroscience and neuroscience-related data.

2\. Tools for neuroscience data visualization (and other forms of
presentation) and manipulation (probabilistic atlases of brain structure
or function, new statistical approaches for analyzing data, etc.).

3\. Software for integration and synthesis of neuroscience data
(computational models of neurons to integrate data about structure and
function, environments to merge data from multiple imaging modalities,
etc.).

4\. Tools for electronic collaboration to allow neuroscientists to
interact with colleagues, data, and instruments at a distance (this
could include novel types of "groupware", etc.).

5\. Tools that bridge existing neuroscience and biology information
tools and resources, such as databases and informatics tools associated
with genome mapping efforts.

M. In addition, we have special interests further detailed in the
following Program Announcements (PAs):

1\. Innovations in Biomedical Computational Science and Technology:
SBIR/STTR Initiative
<http://grants.nih.gov/grants/guide/pa-files/PAR-06-088.html> (SBIR) and
<http://grants.nih.gov/grants/guide/pa-files/PAR-06-089> (STTR).

2\. Development of PET and SPECT ligands for brain imaging
<http://grants.nih.gov/grants/guide/pa-files/PA-06-017.html> (SBIR) and
<http://grants.nih.gov/grants/guide/pa-files/PA-06-018.html> (STTR).

3\. Pharmacologic Agents and Drugs for Mental Disorders
<http://grants.nih.gov/grants/guide/pa-files/PA-06-027.html> (SBIR) and
<http://grants.nih.gov/grants/guide/pa-files/PA-06-028.html> (STTR).

4\. Competing Renewal Awards of SBIR Phase II Grants for Pharmacologic
Agents and Drugs for Mental Disorders
<http://grants.nih.gov/grants/guide/pa-files/PA-06-079.html>.

5\. Probes for Microimaging the Nervous System
<http://grants.nih.gov/grants/guide/pa-files/PA-06-021.html> (SBIR) and
<http://grants.nih.gov/grants/guide/pa-files/PA-06-022.html> (STTR).

6\. Knowledge Integration across Distributed Heterogeneous Data Sources
<http://grants.nih.gov/grants/guide/pa-files/PA-06-011.html> (SBIR) and
<http://grants.nih.gov/grants/guide/pa-files/PA-06-010.html> (STTR).

7\. High Throughput Tools for Brain and Behavior
<http://grants.nih.gov/grants/guide/pa-files/PA-06-023.html> (SBIR) and
<http://grants.nih.gov/grants/guide/pa-files/PA-06-024.html> (STTR).

8\. Bioengineering Nanotechnology Initiative
<http://grants.nih.gov/grants/guide/pa-files/PA-06-008.html> (SBIR) and
<http://grants.nih.gov/grants/guide/pa-files/PA-06-009.html> (STTR).

For further information on basic neuroscience or basic behavioral
science research topics, contact:

Margaret Grabb, Ph.D.

Chief, SBIR/STTR Program

Division of Neuroscience and Basic Behavioral

Science and Division of Pediatric Translational

Research

National Institute of Mental Health

6001 Executive Blvd. Room 7201

Mail Stop Code 9645

Bethesda, MD 20892 or

Rockville, MD 20852-9645 (for Overnight/Courier)

\(301\) 443-3563, Fax: (301) 443-1731

Email: <mgrabb@mail.nih.gov>

[]{#__RefHeading___Toc124236992 .anchor}The Division of Pediatric
Translational Research and Treatment Development

The Division of Pediatric Translational Research and Treatment
Development directs, plans, and supports programs of research and
research training leading to the prevention and cure of childhood
psychopathology. This long-term goal will be accomplished through an
integrated program of research across behavioral/psychological
processes, brain development, environment and genetics. The topics
listed below reflect the NIMH interest in technologies related to this
research area, but should not be considered a complete list. Prospective
applicants are strongly encouraged to contact Dr. Margaret Grabb (listed
below) with questions about the relevance of their interests to the
mission of this division.

A. ***[Technologies for Clinical Pediatric Research.]{.underline}*** It
is important to develop reliable methods that can correctly identify the
normal and abnormal components of cognitive, emotional, and psychosocial
behavior, as well as normal and abnormal physiological and biochemical
functions, in human development. Computer-based methods of accomplishing
this are also needed to increase the accessibility and reliability of
information made available to the research community. Examples include:

1\. *[Measurements of Alterations in Pediatric Development in Patients
with Mental Health Disorders Using Physiological and Behavioral
Measures]{.underline}*. Research studies indicate that some mental
health disorders, such as autism, may begin to develop as early as
infancy. Therefore non invasive modern equipment that use the most
recent technological advances are needed to isolate specific
physiological and behavioral changes during development, to identify
potential diagnostic markers of mental health disorders. A priority for
this program is to support research and development of hardware and
software tools to measure pediatric development. Examples of
technologies needed include:

a\. Psychophysiological measures to evaluate infants, children or
adolescents.

b\. Miniaturized non-invasive instruments to record psychophysiological
data (e.g., heart and respiration rate, galvanic skin response, and
defensive motor behavior).

c\. Telemetry capability for non-invasive devices so that children can
be monitored for prolonged periods without interfering with their
behavior.

d\. Computer programs and inexpensive computers that will collect,
analyze and identify recurring patterns in the psychophysiological
measure(s) of interest.

2\. *[Pediatric Assessment Tools:]{.underline}* Diagnosis of mental
health disorders in children and adolescents is vital to providing early
interventions to treat the disorder. In addition, a better understanding
of the concept of functioning in psychopathology, and its appropriate
measurement, is needed in pediatric populations. In the future,
diagnostic tools may even help detect the initial onset of illness in
children at risk, before symptoms occur. A priority for this program is
to develop novel diagnostic tools to detect mental health disorders in
children and adolescents. Biochemical, genetic, physiological and
psychological tool development is welcomed.

a\. Technologies to assess CNS effects of psychosocial or
pharmacological interventions.

b\. Innovative approaches to assessing mental disorders using new
statistical and psychometric techniques such as Item Response Theory.

c\. Computerized methodologies for assessing various mental disorders
suitable for use in primary care settings.

d\. Measures that quickly, and reliably assess mental disorders that are
co-morbid with other mental disorders or with substance abuse disorders.

e\. New technologies to assess and validate occurrence of and injuries
resulting from child abuse and neglect.

f\. Behavioral and laboratory measures to define and assess specific
impairment-related components of psychiatric disorders, e.g., cognitive
dysfunctions in schizophrenia.

g\. Biologically based technologies that will aid medical doctors in
determining how a particular individual may respond to a particular
medication, i.e. "individualized medicine". For example, genomic and
phenotypic information combined could be used in determining whether a
drug will be an effective treatment for an individual. Likewise, genomic
and phenotypic information may help to identify which patients are at
risk for drug-induced side effects.

h\. Development of valid and reliable measures that operationalize
functioning within and across developmental periods, and that can be
used in a variety of service settings. Such measures can lead to more
accurate diagnoses, a better understanding of the impact of psychiatric
disorders, and better tracking of treatment effectiveness.

3\. *[Behavior Monitoring and Analysis of Pediatric Mental Health
Disorders]{.underline}*.

a\. Improve or create new video devices to monitor human behavior and
ease analysis of behavior.

b\. Computer software to ease analysis of behavior monitored by video or
telemetry systems.

c\. Automated methods to detect specific emotional states using
behavioral and autonomic indicators: This Division is specifically
interested in technologies that can identify children with heightened or
dampened emotional states that could be associated with particular
mental health disorders. If the technology will primarily be used to
investigate basic mechanisms of behavior, the Division of Neuroscience
and Basic Behavioral Science at NIMH would be the most appropriate
division to contact.

4\. *[Methodological Research and Development]{.underline}*. There is a
need to devise new ways of data collection, analysis, management and
dissemination. Examples include:

a\. Instrumentation and equipment that uses the most recent
technological advances is needed so that mental disease can be related
to dysfunction(s) of the CNS. Once these dysfunctions are identified and
localized, rational therapies can be developed and evaluated.

b\. Innovative, computer-based methods to monitor preventive and
treatment intervention efforts and correlate them with outcome measures
are needed. Results should be accessible to other interested parties
without compromising the privacy of the individual.

c\. Development of innovative software for addressing the integration of
distributed cross-disciplinary data sources into coherent knowledge
bases. The data should focus on pediatric mental health disorders.

d\. Computer-based intervention development for parents or for school
settings.

e\. Video-based instruction for prevention of mental disorders, to be
used by parents or in school settings.

f\. Development of databases containing detailed genetic and behavioral
information on pediatric populations and their families, as resources
for the field in investigations of gene x environment interactions.

B. ***[Child and Adolescent Treatment and Preventive Intervention
Research.]{.underline}*** An estimated one in ten children and
adolescents in the United States suffers from mental illness severe
enough to cause some level of impairment. Yet, it remains unclear what
treatments are the best and safest for these developing age groups. A
priority for this program is to support research and development of
novel psychopharmacological or psychosocial approaches for the treatment
and prevention of mental illness in childhood and adolescence, in
subjects aged 18 and below.

The goal of this research is broad and inclusive with respect to the
heterogeneity of patients, the severity and chronicity of disorders, and
the range of outcomes measured. Disorders studied include all mental and
behavioral disorders. Interventions studied include pharmacologic
approaches (individual and combination medications), somatic approaches,
behavioral and psychotherapeutic approaches. Research is supported on
individual and combined approaches. Research that translates findings on
basic physiological or behavioral processes into novel preventive or
treatment interventions is especially encouraged. Effectiveness studies
that focus on interventions of known efficacy are assigned to the
Division of Services and Intervention Research.

Human subjects include child and adolescent age groups covering the full
range of mental disorders individually and in complex patterns of
comorbidity with other mental disorders and behavioral problems (e.g.,
anxiety and depression) and substance abuse (e.g., depression and
alcohol abuse). Examples of the research support include: trials to
establish the short- and long-term efficacy of interventions and
off-label or innovative applications of established interventions.

1\. *[Pharmacologic Treatment Intervention.]{.underline}* Areas include
clinical psychopharmacology, new/innovative applications for established
treatments (off-label use), and somatic treatments. Also included are
studies to determine the safety of interventions that have not been
shown to be efficacious. It is expected that compounds have received IND
approval and will be tested clinically in this program.

2\. *[Combined Intervention]{.underline}*. Areas include all research
that combines different treatment modalities in a single combined or
comparative protocol (e.g., pharmacologic plus psychosocial
intervention).

3\. *[Psychosocial Intervention]{.underline}*. Areas include development
and application of new psychotherapeutic, behavioral, and psychosocial
treatments.

4\. *[Preventive Intervention Program]{.underline}*. Areas include
preventive intervention studies in which efficacy has not been
demonstrated, including those designed to reduce the risk of onset or
delay onset of mental disorders, dysfunctions and related problems
within asymptomatic and subclinical populations and those related to
treatment (e.g., prevention of relapse, recurrence) or side effects
(prevention/ minimization of tardive dyskinesia, etc.). Prevention
studies in schools and community settings are also encouraged.

C. ***[Science Education in Mental Disorders.]{.underline}*** There is a
critical need for improvement in science education, particularly in
areas specifically related to brain, behavior and mental illness.
Examples include:

1\. Research on the best ways to present neuroscience and behavioral
science information, in the context of mental health disorders, to
particular groups of students (e.g., kindergarten through sixth grade).

2\. Computer-based systems to teach students how to observe scientific
phenomena related to the brain, behavior and mental illness, and to
report them clearly in writing.

3\. Research on better ways to communicate new knowledge and directions
of scientific growth in the area of neuroscience and mental illness to
teachers and curriculum developers.

For further information on pediatric translation research and treatment
development topics, contact:

Margaret Grabb, Ph.D.

Chief, SBIR/STTR Program, Division of

Neuroscience and Basic Behavioral Science, and

Division of Pediatric Translational Research and

Treatment Development

National Institute of Mental Health

6001 Executive Blvd. Room 7201

Mail Stop Code 9645

Bethesda, MD 20892 or

Rockville, MD 20852-9645 (for Overnight/Courier)

\(301\) 443-3563, Fax: (301) 443-1731

Email: <mgrabb@mail.nih.gov>

[]{#__RefHeading___Toc124236993 .anchor}Division of Adult Translational
Research and Treatment Development (DATR)

The DATR is responsible for planning, directing and supporting programs
of research, research training, research dissemination and resource
development aimed at understanding the pathophysiology of mental illness
and hastening the translation of behavioral science and neuroscience
advances into innovations in clinical care. The Division supports a
broad portfolio of pre-clinical and human clinical studies that focus on
the phenotypic characterization and risk factors for major psychiatric
disorders. In addition , the Division studies psychiatric disorders of
late life. The division is comprised of four branches. These branches
are: The Adult Psychopathology and Psychosocial Intervention Research
Branch, The Clinical Neuroscience Research Branch, the Geriatrics
Research Branch and the Experimental Therapeutics Branch. Their
respective functions are as follows:

***[Adult Psychopathology and Psychosocial Intervention Research
Branch.]{.underline}*** This branch promotes the integration of basic
behavioral and neuroscience findings into translational research on the
foundations of psychopathology and functional disability. The branch
targets new science based assessment, prevention, treatment and
rehabilitation practices including research on causal risk and
protective factors for mental disorders, mechanisms that convert
vulnerability into psychiatric symptoms and disability and use of modern
psychometric and statistical theories to advance nosology and
assessment. Other specific areas of emphasis include mood, sleep and
eating disorders, anxiety disorders and schizophrenia.

***[Clinical Neuroscience Branch.]{.underline}*** The focus of this
branch is on the understanding of the neural basis of mental disorders.
Human and animal studies are supported on the molecular, cellular and
systems level of brain function designed to elucidate the
pathophysiology of mental disease and to translate these findings to
clinical diagnosis, treatment and prevention. These approaches are
applied to the spectrum of mental disorders including schizophrenia,
depression, bipolar disorder, anxiety disorder and other brain
disorders. Areas of emphasis include: identification of valid and unique
neurophysiological markers or complexes of markers for the major mental
disorders and development of animal and or computational models that
accurately mimic complex neurophysiology or behaviors characteristic of
mental illness.

***[Geriatrics Research Branch.]{.underline}*** This branch focuses on
research, research training and resource development in the etiology and
pathophysiology of mental disorders of late life as well as the
treatment and rehabilitation of persons with these disorders. Disorders
studied include Alzheimer's disease and related dementias, psychotic
disorders and schizophrenia, mood, anxiety and personality disorders,
suicide, sleep disorders and eating disorders. Selected areas of
emphasis include: development of more reliable and valid phenotypes,
assessments and behavioral markers for late-life mental disorders,

***[Experimental Therapeutics Branch.]{.underline}*** This branch
supports multidisciplinary research on novel pharmacological approaches
to the treatment of mental disorders, evaluation of existing treatments
of mental disorders, development and assessment of putative biomarkers
of psychiatric disease and treatment response and development and
testing of novel treatments. Studies supported include early phase
clinical studies of new medications, studies to predict treatment
response and studies to validate biomarkers or predictors of therapeutic
response to pharmacological intervention. Side effects of therapeutic
agents are also given emphasis. Programs exist to develop new treatments
for psychotic disorders and also for mood and anxiety disorders.

All applications relevant to the mission of the Division of Adult
translational Research and Treatment Development will receive full
consideration. Possible areas for future research include:

A. ***[Instrumentation for Clinical Research.]{.underline}*** Modern
equipment that uses the most recent technological advances is needed so
that mental disease can be related to dysfunction(s) of the CNS. Once
these dysfunctions are identified and localized, rational therapies can
be developed and evaluated.

1\. *[Physiological Monitoring]{.underline}*. Techniques and equipment
for continuous monitoring of physiological data (e.g., temperature,
activity, sleep duration, EEG activity, ECG, pulse rate). Computer
programs that can record, catalog, categorize and identify
interrelationships between several of the above measures. Appropriate
areas for clinical research would include developing:

a\. Reliable non-invasive means of chronic monitoring of physical
activity and physiological measures such as body temperature.

b\. Software and hardware analyzing and providing experimental control
over multiple single unit recordings, on-line and in real time.

2\. *[Development of Adult Physiological and Behavioral
Measures]{.underline}*.

a\. Miniaturized non-invasive instruments to record psychophysiological
data (e.g., heart and respiration rate, galvanic skin response, and
motor behavior).

b\. Telemetry capability for non-invasive devices so that adults can be
monitored for prolonged periods without interfering with their behavior.

c\. Computer programs and inexpensive computers that will collect,
analyze and identify recurring patterns in the psycho-physiological
measure(s) of interest.

d\. Automated methods to detect specific emotional states using
behavioral and autonomic indicators in adults.

3\. *[Behavior Monitoring and Analysis]{.underline}*.

a\. Improve or create new video devices to monitor animal and human
behavior and ease analysis of behavior.

b\. Computer software to ease analysis of behavior monitored by video or
telemetry systems.

B. ***[Technologies for Adult Clinical Research.]{.underline}*** It is
important to develop reliable methods that can correctly identify the
normal and abnormal components of cognitive, emotional, and psychosocial
behavior in human development. Computer-based methods of accomplishing
this are also needed to increase the accessibility and reliability of
information made available to the research community.

1\. *[Assessment Tools]{.underline}*.

a\. New technologies to assess and validate occurrence of and injuries
resulting from physical and sexual abuse or from trauma as a result of
terrorism or natural disaster

b\. Technologies to assess CNS effects of psychosocial variables and
interventions.

c\. Innovative approaches to assessing mental disorders using new
statistical and psychometric techniques such as Item Response Theory.

d\. Computerized methodologies for assessing various mental disorders
suitable for use in primary care settings.

e\. Inexpensive methodologies or techniques for assessing adherence to
medication regimens.

2\. *[Methodological Research and Development]{.underline}*. There is a
need to devise new ways of data collection, analysis, management and
dissemination.

a\. New relatively culture-free taxonomies and/or measures of basic
behavioral and social phenomena that can be employed in research across
socio-cultural contexts.

b\. Innovative computer-based observation techniques, and computer
software and hardware that allow on-line methods for characterization of
interpersonal interactions in groups.

c\. Low cost microcomputer software for the recording and analysis of
patterns and sequences in observed social interactions.

d\. Causal modeling methodology as applied to correlational longitudinal
data sets.

e\. A data translation and communication package for collecting,
archiving, and making available existing longitudinal behavioral sets to
the scientific community for secondary or meta-analyses.

f\. Flexible user-friendly software for control of timed, multi-modal
stimulus presentation and response collection for experiments on
perception and cognition.

g\. Development of improved standardized instruments and methods for
assessing assets, deficits, and disorders in adult and late life.

C. ***[Adult Treatment and Preventive Intervention
Research]{.underline}***

1\. Development of novel methods to enhance efficiency of early phase
clinical trails.

2\. Development of novel assessments of psychopathology suitable for use
in clinical research.

3\. Identification of causal risk and protective factors for mental
disorders.

4\. Development of standardized assessments of psychiatric and comorbid
disorders.

5\. Develop psychometrically sound methods for assessing the cognitive,
affective and behavioral response systems believed to underpin clinical
symptoms and functional impairments.

6\. Identify valid markers of illness onset.

7\. Develop new definitions and measures to assess functioning in people
with psychiatric disorders including self-reports, tests that simulate
real-world tasks and new approaches to ratings by observers.

8\. Creation and validation of new measures of functional capacity.

9\. New approaches to assess the functional effects of drug or
psychosocial interventions to treat mental disorders.

10\. Identify valid and unique neuropsychological markers for the major
mental and personality disorders.

11\. Identify more reliable and valid phenotypes, assessments and
behavioral markers for late-life mental disorders.

12\. Development of techniques for maintaining or restoring mental
capacities in older adults who experience declining learning and memory
abilities due to age-related brain disorders.

D. ***[Experimental Therapeutics Research.]{.underline}***

1\. Early phase clinical studies of new medications targeting major
mental illnesses or symptom domains now lacking adequate treatments.

2\. Studies to validate new biomarkers or predictors of therapeutic
response to pharmacological interventions.

3\. Development of novel somatic treatments or medical devices for the
treatment of mental illness.

4\. Development of biomarkers or predictors of treatment response or
side effects of therapeutics.

5\. Development of new approaches to understand and predict the types,
rates and pathophysiology of adverse effects of psychotropic
medications.

6\. New approaches to understand age-related changes on the emergence of
adverse effects from psychotropic medications.

7\. Development of new techniques to predict emergence of later
abnormalities in body weight and disorders of glucose and lipid
metabolism during treatment with psychotropic drugs.

8\. New methods to predict and assess the effects of psychotropic
medication on cerebrovascular and cardiovascular function.

9\. New approaches, including pharmacological to prevent or reduce the
negative metabolic, vascular and other side effects of psychotropic
medications.

For further information on these topics, contact:

Dr. Louis Steinberg

Division of Adult Translational Research and Treatment Development

6001 Executive Blvd., Room 6219B, MSC 9621

Bethesda, Maryland 20892-9621

301 443-6100, Fax 301 443-9719

Email: <lsteinbe@nih.gov>

[]{#__RefHeading___Toc124236994 .anchor}Division of AIDS and Health and
Behavior Research (DAHBR)

The DAHBR supports research and research training to develop and
disseminate behavioral interventions that prevent HIV/AIDS transmission,
understand and alleviate the neuropsychiatric consequences to HIV/AIDS
infection and, using a public health model, supports studies to reduce
the burden of mental illness from medical co-morbidities, non-adherence
to treatment, stigma and health disparities. In addition to the topics
listed below, the Center welcomes a wide range of applications dealing
with HIV/AIDS prevention issues. Inquiries are encouraged. Examples of
possible SBIR initiatives include:

A. ***[Behavior Change and Prevention Strategies.]{.underline}*** To
reduce HIV transmission especially among minority populations and hard
to reach subsets of those populations.

1\. Development of methods to reduce, prevent and/or change
HIV-associated and STD risk behaviors.

2\. Development of relapse prevention methods for HIV-associated risk
behaviors.

3\. Development of curricula for training clinicians and other health
care practitioners in the prevention and treatment of HIV-related mental
disorders.

4\. Development of school-based curricula to promote HIV prevention by
educators and teachers.

5\. Development of HIV prevention materials to be used in
community-based outreach programs for special populations (school
dropouts, homeless, street youth, incarcerated youth).

6\. Development of curricula for training in multicultural issues and
development of cultural competence in HIV risk assessment, counseling,
and prevention.

7\. Development of print and/or computer based materials to assist
primary care practitioners in informing their patients about HIV risk
and prevention.

8\. Development of innovative approaches to reduce stigma often
expressed toward individuals with HIV/AIDS.

9\. Development of materials and other programs to assist health care
practitioners in improving patient adherence to medical and lifestyle
regimens.

10\. Development of low cost strategies to assist community-based
organizations in using computers to educate hard to reach populations
about HIV risk and prevention.

11\. Development of strategies to assist organizations in identifying
and implementing proven HIV prevention strategies and in addressing
health disparities.

12\. Methods to increase use of HIV testing and facilitate effective
test result confirmation and counseling.

13\. Development of new behavioral strategies to reduce high risk
behavior among persons recently infected.

B. ***[Neuro-AIDS: HIV-1 Infection and the Nervous
System.]{.underline}***

1\. Development of novel non-invasive (e.g., neuroimaging) approaches to
assess and study mechanisms of neurologic and neurocognitive dysfunction
associated with HIV infection.

2\. Development of in-vivo and in-vitro models to assess mechanisms of
HIV-1 trafficking into and out of the CNS, mechanisms of
neuropathogenesis and therapeutic strategies for eradicating HIV-1 in
the CNS.

3\. Development of novel molecular markers for NeuroAIDS using
proteomics, microarrays and neuroimaging.

4\. Development of novel molecular approaches to study compartmentalized
viral evolution in the CNS.

5\. Development of improved anti-retroviral therapeutic strategies for
targeting CNS infections including: facilitated entry of anti-retroviral
therapeutic agents through the blood-brain barrier by manipulation of
transporter systems and development of novel anti-retroviral therapeutic
agents that readily pass through the blood-brain barrier.

6\. Development of novel therapeutic approaches to block or reverse CNS
dysfunction associated with HIV infection.

7\. New approaches to reduce transmission risk or neuro-cognitive
impairment in persons with recent HIV infection (0-6 months post
exposure).

C. ***[AIDS Mental Health Services Delivery.]{.underline}***

1\. Video and computer-assisted methods to train health and mental
health care providers in the psychosocial and neuropsychiatric aspects
of HIV infection and AIDS.

2\. Development of methods to assess functioning in families in which
there is an HIV infection in order to develop improved treatment
modalities.

3\. Development of novel programs to train people infected with HIV in
self-care management and identification of stress and development of
improved coping strategies in order to improve quality of life.

4\. Development of novel programs to help people recognize and seek
treatment of mental health problems arising from living with HIV/AIDS as
a long-term chronic condition.

5\. Development of information, instruments or methodologies to improve
and/or track adherence to complex HIV/AIDS drug therapies for Hispanic
and African American populations.

6\. Development of innovative approaches to link researchers with
community providers in the implementation of research-based HIV
prevention efforts at the community level.

D. ***[Health and Behavior Research.]{.underline}***

1\. Development of behavioral strategies to assess mental health
functioning and disability.

2\. Research on identifying and addressing the sociocultural factors
involved in mental health disparities.

3\. Research on improving adherence to behavioral or pharmacological
treatments.

4\. Research on identification of risk factors for poor adherence.

5\. Research on improved approaches to accurately identifying co-morbid
disorders.

6\. New approaches to improve the diagnosis and assessment of co-morbid
physical and mental disorders.

7\. Development and evaluation of new programs and strategies for self
management and behavior change for persons with co-morbid mental and
physical disorders.

8\. New behavioral approaches to treatment of co-morbid mental and
physical disorders in the elderly.

9\. Development of new approaches to reduce stress in people with mental
disorders.

10\. Development of new approaches and strategies to reduce stigma
directed at persons with mental disorders.

For further information on these topics contact:

Dr. Louis Steinberg

Division of AIDS and Health and Behavior Research 6001 Executive
Boulevard

Room 6219 B, MSC 9621

Bethesda, Maryland 20892-9621

\(301\) 443-6100, Fax: (301) 443-9719

Email: <Lsteinbe@nih.gov>

[]{#__RefHeading___Toc124236995 .anchor}Division of Services and
Intervention Research

The Division of Services and Interventions Research supports research,
research demonstrations, research training, resource development, and
research dissemination in prevention and treatment interventions,
services research, clinical epidemiology, and diagnostic and disability
assessment. The division is comprised of three branches: Services
Research and Clinical Epidemiology Branch, Adult and Geriatric Treatment
and Preventive Intervention Research Branch, and Child and Adolescent
Treatment and Preventive Intervention Research Branch.

The Division supports two critical areas of research:

-   Intervention research to evaluate the effectiveness of
    pharmacologic, psychosocial (psychotherapeutic and behavioral),
    somatic, rehabilitative and combination interventions on mental and
    behavior disorders-including acute and longer-term therapeutic
    effects on functioning across domains (such as school, family, peer
    functioning) for children, adolescents and adults.

-   Mental health services research

The interventions focus is broad and inclusive with respect to the
heterogeneity of patients, the severity and chronicity of disorders, and
the variety of community and institutional settings in which treatment
is provided. It includes clinical trials evaluating the effectiveness of
known efficacious interventions, as well as studies evaluating modified
or adapted forms of interventions for use with additional populations
(such as women, ethnic and racial groups), new settings (public sector,
pediatric primary care, schools, other non-academic settings,
communities at large) and people with co-occurring disorders. Other foci
include: identifying subgroups who may be more likely to benefit from
treatment, evaluating the combined or sequential use of interventions
(such as to extend effect among refractory subgroups), determining the
optimal length of intervention, establishing the utility of continuation
or maintenance treatment (that is, for prevention of relapse or
recurrence), and evaluating the long-term impact of efficacious
interventions on symptoms and functioning.

Services research covers all mental health services research issues,
across the lifespan and disorders, including, but not limited to:

-   Services organization, delivery (process and receipt of care), and
    related health economics at the individual, clinical, program,
    community and systems levels in specialty mental health, general
    health, and other delivery settings (such as the workplace).

-   Interventions to improve the quality and outcomes of care (including
    diagnostic, treatment, preventive, and rehabilitation services.

-   Enhanced capacity for conducting services research

-   The clinical epidemiology of mental disorders across all clinical
    and service settings.

The Division also provides biostatistical analysis and clinical trials
operations expertise for research studies; analyzes and evaluates
national mental health needs and community research partnership
opportunities; and supports research on health disparities.

During FY2006 SBIR grant priorities include:

1\. **Clinical Trials Methodologies:** The development, testing and
refinement of methodologies, instruments and statistical approaches to
facilitate collaborative clinical trials for the prevention, treatment
and rehabilitation of individuals with mental disorders; the development
of innovative trials design (e.g., fixed adaptive, encouragement,
partially randomized preference) the application of modern technology to
enhance the science, operation, and management of multi-site mental
health clinical trials; and the development of mental health clinical
trial archives.

2\. **Science Training and Education:** SBIR applications must focus on
DSIR's research priorities. Develop, modify and test new and existing
technologies, strategies and approaches to: (1) enhance science and
research training across the educational/ career pipeline; (2) improve
scientific literacy for clinicians and service/ organizational
providers; (3) encourage entry and retention of individuals with
non-mental health science backgrounds (engineers, computer scientists,
medical anthropologists, law, business) or perspectives (individuals
from under-represented communities) into the mental health services and
interventions field; (4) keep established researchers and practitioners
up-to-date on the findings, implementation, and methods of services and
interventions research; and (5) facilitate *participatory* research with
individuals, families and communities. This can include the development
of science/ research education materials, curriculum, methodologies and
web-based programs relevant to the mission of the division; the
development of networking and collaborative approaches to research
training in mental health interventions and services research; and the
development of multi-media approaches (combined with traditional
strategies) to improve the level of scientific and career mentoring that
mental health services and interventions researchers receive.

3\. **Public Health Oriented Pharmacoeconomics:** Develop and test
simulation models for estimating the amount of total out-of-pocket
expenditures (co-payments) for the most frequently prescribed
psychotropic drugs under different insurance benefit scenarios and/or
under different pharmacy benefit management scenarios. Models should
also be developed to accommodate common combined pharmaceutical
approaches.

4\. **Dissemination:** Development of technological approaches to
increase the sustainable uptake of scientifically based treatments and
services across diverse community settings. This could include web-based
interactive tools for state/county mental health or related (e.g.,
schools) agencies around implementation of evidence-based practices.
Development of innovative ways (e.g., new technology, use of
multi-media) of disseminating information to stakeholders. Development
of new approaches to the dissemination and implementation of evidence
based mental health interventions to underserved populations (e.g.,
rural/frontier, aging individuals with neuropsychiatric disorders).

5\. **Implementation:** Application of new technologies, approaches and
strategies to identify and utilize active therapeutic ingredients in
complex community-based services and programs that optimize functioning
and sustain community reintegration of people with mental disorders. Use
of technologies and strategies to assist service systems to more
adequately plan for transitions (e.g., child to adult system, prison to
community) and seamlessly integrate mentally ill individuals moving
between these sectors.

6\. **Merging Multiple Data Sets:** Merging multiple data sets (e.g.,
claims, trials, pharmacy etc.) for innovative and complex analytic
strategies.

7\. **Community Outreach to Diverse and Underserved Populations:**
Application of new technologies and strategies to develop, test, and
refine culturally appropriate materials and approaches to: (a) foster
help-seeking and engagement of diverse and underserved populations in
research-based mental health treatment and prevention; to foster
participation in community based research by diverse and underserved
populations; and to inform diverse provider groups about
state-of-the-art mental health treatments and services in order to
facilitate their implementation of these interventions.

A. ***[Services Research and Clinical Epidemiology
Branch.]{.underline}*** The branch supports research on the
organization, financing, delivery, effectiveness, and appropriateness of
mental health care in everyday settings in order to find ways to improve
the effectiveness, efficiency, and equity of mental health services
(including preventive services) in community and other settings. Also
supported are studies on pharmacoeconomics, pharmaco-epidemiology, and
the distribution, determinants, and course of mental illness in the
context of various clinical settings. Mental health services include
mental health care provided in specialty mental health and general
health care settings, including primary care, hospitals, nursing homes,
and other residential care settings, as well as in educational settings
and various legal system settings, such as jails, juvenile detention and
correctional facilities, prisons, and probation and parole programs.
Other services often needed by mentally ill persons include social
services, vocational and rehabilitation services, welfare, and housing.
Relevant services include those provided to children and adolescents
with emotional disorders, adults and elderly adults with mental
disorders, and persons with mental illness that co-occurs with physical
illness and with alcohol and/or drug abuse disorder. Research
methodologies include ethnographic studies, surveys, and analyses of
secondary data, randomized controlled trials, quasi-experimental
designs, cohort, and case-control studies.

Advances in clinical epidemiology, mental health treatment and services
research fields have made it imperative that intensive work continue in
the areas of assessment/screening technologies, outcome assessment
measurement and measurement packages, dissemination technologies, data
analysis techniques, and the training of clinicians and providers. The
translation of efficacious and effective treatments into primary care,
community mental health centers, and managed care settings is both a
major challenge and opportunity to develop technologies and systems that
will improve the care and rehabilitation of patients and enable them to
profit from the research advances that have been made. Research is
needed on the dissemination of empirically supported treatments or
services.

1\. *[Methodological Research Program]{.underline}*. Supports studies
that involve development, testing, and refinement of methodologies and
instruments to facilitate research on services for mentally ill persons,
including measures of severity of illness, family burden, social
support, quality of care, effectiveness of care, direct and indirect
cost of mental disorders, and short-term and long-term outcome measures;
studies submitted by statisticians, psychometricians, and other experts
in research methodology and scientific data analysis for work on the
design, measurement, and statistical challenges inherent in conducting
mental health services research.

2\. *[Outcomes and Quality of Care Research]{.underline}*. This program
is concerned with strengthening the theoretical and empirical base for
mental health services research by including approaches that derive from
sociology, anthropology, and the behavioral sciences in general. The
program supports research relating to issues of culture, social systems,
and social networks as they relate to help seeking, use, and provision
of services, effectiveness, quality, and outcomes of services.

3\. *[Systems Research Program]{.underline}*. Supports studies on
organization, coordination, and collaboration of mental health and
related services both within and across care settings in order to
improve mental health outcomes and prevent or treat co-occurring
substance abuse, physical problems, and other behavioral health
disorders. Service sectors of interest include: the criminal justice
system, housing and other social services, community support,
post-trauma services, and adult autism services. Also relevant are
studies to establish the effectiveness of legal mechanisms relevant to
persons with mental illness, such as outpatient commitment, community
monitoring, and guardianship; and the development of the role and
expertise of social workers in mental health research activities.

4\. *[Disparities in Mental Health Services Program.]{.underline}*
Plans, stimulates, disseminates, and supports research on the complex
factors that influence disparities in mental health services,
particularly across special population groups such as racial and ethnic
groups, as well as women and children, and persons living in rural and
frontier areas. The program addresses care delivered in a variety of
settings such as the specialty mental health sector, the general medical
sector, and community settings (such as schools). Also, it supports
research that examines innovative services interventions (such as
community-based participatory methods, faith-based) to overcome mental
health disparities related to mental health service delivery and use.

5\. *[Sociocultural Research Program]{.underline}*. Is concerned with
strengthening the theoretical and empirical base for mental health
services research by including approaches that derive from sociology,
anthropology, and the behavioral sciences in general. The program
supports research relating to issues of culture, social systems, and
social networks as they relate to help seeking, use, and provision of
services, effectiveness, quality, and outcomes of services.

6\. *[Child and Adolescent Services Research Program]{.underline}*.
Includes research on the quality, organization, and content of services
for children with mental disorders and their families. The program
focuses on child mental health services provided in multiple sectors and
settings, such as schools, primary care, child welfare, juvenile
justice, and mental health. Program emphases include practice research
within child service systems, research testing the outcomes of
innovative child service delivery models, and studies that examine the
adaptability or sustainability of child mental health services.

7\. *[Financing and Managed Care Research.]{.underline}* Supports
research on economic factors affecting the delivery of mental health
services including the economic burden of mental illness; financing and
reimbursement of public and private mental health services; impact of
various forms of managed care and physician payment methods on the cost
of mental health care; pharmaco-economics; evaluation of the impact of
insurance coverage including mandated coverage and mental health
insurance parity on access, cost, and quality; cost-benefit,
cost-effectiveness and cost-utility analysis of mental health service
interventions; and economic analysis of practice patterns of different
mental health providers. The goal of the program is to expand
understanding of the role of economic factors in the delivery and use of
mental health services and assist in the development of improved mental
health financing methods promoting high quality, cost-effective care for
people suffering from mental disorders.

8\. *[Primary Care Research]{.underline}*. Includes studies on the
delivery and effectiveness of mental health services within the general
health care sector; recognition, diagnosis, management, and treatment of
mental and emotional problems by primary care providers; coordination of
general medical care with and referrals to mental health specialists;
provision of psychiatric emergency services, consultation/liaison
psychiatry, and other psychiatry, psychology, and social work services
within the general medical care sector; studies that improve
understanding of how best to improve care for people with mental
disorders and co-occurring physical conditions.

9\. *[Clinical Epidemiology Research]{.underline}*. Includes
epidemiologic studies of mental disorders in clinical settings, that is,
the distribution of treatments and services in a population; studies to
determine usual or best practices and the relationship to patient,
provider, and system factors, as well as to outcomes;
pharmaco-epidemiology studies; research to identify factors for the
development of mental disorders in clinical settings, factors important
in the natural history of mental disorders, including comorbid
conditions, and the rates of occurrence of mental disorders in clinical
and services populations.

10\. *[Disablement and Functioning Research Program]{.underline}*.
Supports studies on the development of methodologies for assessing
disablements and functional status, and the development of global and
specific measures of disablements and functional status; the
identification and assessment of disablements/functional status in
clinical investigations and in clinical epidemiological surveys. In
addition, it supports studies of the relationship of rehabilitative and
traditional mental health services and service systems; impact of
disability benefits and insurance; factors affecting impairments and
disabilities during and as an outcome of rehabilitation and other
treatments; rehabilitative services focused on specific domains of
disabilities, such as work and social relationships; and, factors that
influence and sustain community reintegration.

11\. *[Dissemination and Implementation Research Program.]{.underline}*
Includes studies that will contribute to the development of a sound
knowledge base on the effective transmission of mental health
information to multiple stakeholders and of the process by which
efficacious interventions can be adopted within clinical settings.
Research on dissemination will address how information about mental
health care interventions is created, packaged, transmitted, and
interpreted among a variety of important stakeholder groups. Research on
implementation will address the level to which mental health
interventions can fit within real-world service systems. Related topics
include multilevel decision-making perspectives about services and
interventions in community settings, with special focus on translating
behavioral science into applied research in these areas.

B. ***[Adult Treatment and Preventive Interventions Research
Branch.]{.underline}*** This Branch supports research evaluating the
therapeutic (acute, maintenance, and preventive) and adverse effects of
psychosocial, psychopharmacologic, and somatic interventions of proven
efficacy in the treatment of mental disorders in adults. It includes
trials evaluating and comparing the effectiveness of known efficacious
interventions, as well as studies evaluating modified or adapted forms
of interventions for use with specialized populations (such as women, or
specific ethnic or racial groups), new settings (public sector, or
computer based), new methods of treatment delivery (e.g., web or
computer --based), and people with comorbid physical or mental
disorders.

1\. *[Somatic Treatments Program.]{.underline}* Areas include
electroconvulsive therapy (ECT), repetitive transcranial magnetic
stimulation (RTMS), bright light, physical exercise, and similar
nonpharmacologic approaches for which efficacy has been demonstrated.

2\. *[Adult Psychotherapy Intervention Program.]{.underline}* Areas of
program responsibility include evaluation of the effectiveness of
psychotherapeutic, behavioral, and pspychosocial treatments, assessment
of standardized approaches to treatment (based on treatment manuals),
and applications of psychotherapy treatments.

3\. *[Adult Psychopharmacology Intervention Program.]{.underline}* Areas
of program responsibility include research involving psychotropic
medications of demonstrated efficacy. Examples include evaluation of
long-term effectiveness of pharmacotherapy and treatment of
subpopulations of recognized diagnostic groups.

4\. *[Adult Integrated Treatment Program.]{.underline}* Areas of program
responsibility include the use of combined or sequential treatment
approaches to improve long-term outcome. A major focus is improvement of
efficacious psychopharmacological interventions to maximize symptomatic
relief while minimizing adverse reactions. For example, medications may
be combined with the full range of therapies in individual, conjoint, or
group settings.

5\. *[Preventive Interventions Program.]{.underline}* Areas of program
responsibility include studies evaluating the effectiveness of
preventive interventions, including those designed to reduce the
occurrence of mental disorders, dysfunctions and related problems within
asymptomatic and subclinical populations and those related to treatment
(such as prevention of relapse, recurrence, inappropriate resource use)
or side effects. A specially designated programmatic focus is the area
of suicide prevention.

6\. *[Rehabilitative Interventions.]{.underline}* Areas of program
responsibility include evaluation of the effectiveness of
psychotherapeutic, behavioral, and psychosocial treatments, assessment
of standardized approaches to treatment (based on treatment manuals),
and applications of psychotherapy.

C. ***[Child and Adolescent Treatment and Preventive Intervention
Research Branch.]{.underline}*** The branch supports research to
evaluate the effectiveness of mental health preventive, treatment and
rehabilitative interventions- alone or in combination-for children and
adolescents (including those co-occurring with other conditions). The
Branch also supports research addressing the long-term effectiveness of
known efficacious interventions, including their role in the prevention
of relapse and recurrence of mental disorders.

Areas of emphasis include: Research on the effectiveness of treatment
interventions for childhood and adolescent mental and behavioral
disorders in practice and community settings to determine the real life
therapeutic benefit short-and-long term; Research to prevent mental and
behavioral disorders in children and adolescents; Research to build new
methodologies that can be effectively used to evaluate the safety of
interventions in community settings; Research to determine whether
treatment of mental and behavioral disorders in children results in
improved outcomes as adolescents and young adults and prevents the
negative functional outcomes associated with those disorders (such as
substance abuse, academic failure, higher medical costs, co-occurring
mental disorders). juvenile justice facilities.

1\. *[Pharmacologic Treatment Intervention Program.]{.underline}* Areas
of program responsibility include evaluation and comparison of
efficacious pharmacological and other somatic treatments for children
and adolescents with mental disorders.

2\. *[Combined Intervention Program. Child and Adolescent Combined
Intervention Program.]{.underline}* Areas of program responsibility
include all research that combines different treatment modalities in
which efficacy has been demonstrated in a single combined or comparative
protocol.

3\. *[Psychosocial Intervention Program.]{.underline}* Supports research
evaluating the effectiveness of psychosocial interventions on children's
and adolescents mental and behavior disorders, including acute and
longer-term therapeutic effects on functioning across domains. It
includes trials evaluating the effectiveness of known efficacious
interventions, as well as studies evaluating modified or adapted forms
of interventions for use with additional populations, new settings, and
people with comorbid disorders.

4\. *[Preventive Intervention Program.]{.underline}* Areas of program
responsibility include research examining the effectiveness of
preventive intervention studies, including those designed to reduce the
occurrence of mental disorders, dysfunctions and related problems with
asymptomatic subclinical populations.

For further information on Services and Intervention Research contact:

Dr. Enid Light

Division of Services and Intervention Research

6001 Executive Boulevard

Room 7160, MSC 9635

Bethesda, MD 20892-9635

\(301\) 443-1185

Email: <elight@mail.nih.gov>

[]{#__RefHeading___Toc124236996 .anchor}National Institute of
Neurological Disorders and Stroke (NINDS)

The mission of NINDS is to reduce the burden of neurological disease---a
burden borne by every age group, by every segment of society, by people
all over the world. To this end, the Institute supports and conducts
research on the healthy and diseased brain, spinal cord, and peripheral
nerves. Hundreds of disorders afflict the nervous system. Common killers
and disablers such as Parkinson\'s disease, Alzheimer\'s disease,
multiple sclerosis, stroke, epilepsy, and autism are well known. Other
disorders we study may be known only to the patients and families
affected, their doctors, and scientists who look to rare disorders for
help in understanding the brain as well as treating more common
diseases.

[]{#__RefHeading___Toc124236997 .anchor}Phase II Competing Renewal
Awards

NINDS will accept Phase II SBIR/STTR Competing Renewal grant
applications to continue the process of developing products that require
approval of a federal regulatory agency. Such products include, but are
not limited to: medical implants, drugs, biologics, and new treatment or
diagnostic tools that require FDA approval.

NINDS will accept applications for up to three years that do not exceed
\$750,000 per year in direct costs or \$1,000,000 per year in total
costs.

The following examples would make appropriate topics for proposed SBIR
or STTR Phase II Competing Renewal projects. This list is not meant to
be all-inclusive, and applications for other appropriate activities will
be accepted.

1\. Studies for preclinical discovery and development of drugs to treat
neurological disorders, including pharmacology and toxicology studies,
beyond those conducted under the initial SBIR Phase I and Phase II
grants. The studies conducted under the previous grants should be
sufficient to provide a sound rationale for continued development .

2\. Completion of studies as required by the FDA for an IND application.

3\. Human clinical trials/studies to determine the safety profile,
metabolism, and/or efficacy of a drug.

4\. Safety and effectiveness studies of novel medical devices.

Please contact Dr. Randall Steward (contact information provided below)
before beginning the process of preparing an application. Prospective
applicants are strongly encouraged to submit a letter of intent that
includes the following information:

-   Descriptive title of the proposed research

-   Name, address, and telephone number of the Principal Investigator

-   Names of other key personnel

-   Participating institutions

-   Funding Opportunity Announcement Number (e.g., PA-06-XXX)

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 NIH staff to estimate the potential review
workload and plan the review. It is expected that only a portion of
NINDS SBIR/STTR Phase II awards will be eligible for a Competing Renewal
grant.

Any Phase II Competing Renewal applications that do not propose to
develop products that require regulatory approval, or that exceed the
direct or total cost budget caps, will be withdrawn from consideration
prior to peer review.

Randall R. Stewart, Ph.D.

SBIR/STTR Program Coordinator

Program Director for Channels, Synapses and Circuits

National Institute of Neurological Disorders and Stroke

National Institutes of Health

Neuroscience Center, Room 2135

6001 Executive Blvd.

Bethesda, MD 20892-9523

(For courier delivery, Rockville, MD 20852)

301-496-1917; Fax: 301-402-1501

Email: <stewartr@ninds.nih.gov> or <rs416y@nih.gov>

Examples of research topics within the mission of the NINDS that may be
of interest to small businesses are shown below. For additional
information about areas of interest to the NINDS, please visit our home
page at [http://www.ninds.nih.gov](http://www.ninds.nih.gov/).

Extramural research is organized in the following programmatic areas
within NINDS: neurodevelopment, neurogenetics, repair and plasticity,
systems and cognitive neuroscience, channels, synapses and circuits,
neurodegeneration, neural environment, and technology development.
Specific areas of interest are listed below:

[]{#__RefHeading___Toc124236998 .anchor}Neurodevelopment

A. Development of computer software to permit reconstruction of magnetic
resonance imaging (MRI) from unrestrained patients or animals that may
change position within the MRI magnetic field.

B. Development of technology to assess fetal neurological integrity such
as fetal MEG.

C. Non-invasive monitoring of brain function such as improvements in PET
imaging, MRI imaging and spectroscopy, and methods of optical imaging
such as development of near infrared spectroscopy (NIRS) for monitoring
of changes in cerebral oxygen saturation, cerebral blood flow and
volume, and oxygen utilization in the brain, and for functional imaging
utilizing scattering and absorption characteristics of brain tissue.

D. Non-invasive techniques for structural imaging, such as near infrared
imaging.

E. Development of computerized histological tomographic brain atlas
graphics, which can be stored and manipulated on a personal computer for
teaching, research data modeling and display, and correlation with
clinical neuroimaging.

F. Development of practical imaging modalities in extremely ill very low
birth weight infants.

G. Non-invasive techniques for assessment and continuous bedside
monitoring of cerebral function in the neonate, such as, but not limited
to, functional near infrared spectroscopy and amplitude-integrated EEG.

H. Development of improved technology for MRI imaging of infants and
small children, for example, specially designed pediatric sized head
coils, or devices to minimize movement artifact in unsedated infants.

[]{#__RefHeading___Toc124236999 .anchor}Neurogenetics

A. Analysis of central nervous system cell lineages for treatment of
neurodevelopment and degenerative disorders.

B. Development of embryonic stem cell models of nervous system
development and function.

C. Development of technology for the production of high quality cDNA
libraries from small tissue samples of the brain during development and
in response to disease, injury or pharmacological agents.

D. Identification of optimal DNA vector systems to standardize and
expedite the sequencing of cDNA libraries derived from micro dissected
brain tissues.

E. Development of technology for micro dissection of brain tissue for
single cell analysis of gene expression.

F. Development of informatics systems to expedite the analysis and use
of sequence data that will be derived from projects to identify novel
genes and to map temporal and spatial dimensions of gene expression in
the brain.

G. Development of proteomics technologies to quantitatively detect
levels of expression, post-translational modifications, and subcellular
distribution of proteins in the nervous system.

H. Development of technology to detect and quantify metabolite
(carbohydrates, lipids, peptides) changes in the nervous system.

I. Development of in vitro methods to either fractionate membrane
proteins or express recombinate membrane proteins at sufficient levels
for proteomics analyses.

J. Development of technology for single-cell analysis of neurons and
glia to detect dynamic changes in the transcriptome, proteome, and
metabolome.

K. Development of methodologies to deliver therapeutics (gene vector,
drugs, enzymes) across the blood-brain-barrier.

L. Improved methodologies for creating transgenic animal models for
diseases in the nervous system.

M. Development, testing, and evaluation of devices, methods, or drugs to
aid in the prevention, diagnosis and treatment of CNS tumors.

N. Advancement of molecular analysis of DNA, RNA and protein in CNS
tumors.

O. Surrogate markers for cerebrovascular, immune, and infectious
diseases and CNS tumors.

P. Develop methods for identification of specific neural cell lineages.

Q. Techniques for brain specific antisense, gene and protein transfer
into cerebrovascular, neurons, or glial cells in brain tumors.

R. Methods to deliver brain specific proteins and genes through the
blood-brain and blood-CSF barriers for targeting CNS tumors.

S. Mass spectrometry for the analysis of protein in the CNS and in brain
tumors.

T. Highly specific radiolabeled markers for different types of brain
tumors that can be used under histopathological or brain imaging
conditions.

U. Development of an intracranial pressure monitor.

V. Refinement of functional, structural and metabolic imaging techniques
for brain tumors.

W. Methods and devices for high throughput genomic and proteomic
expression and data analysis in brain tumor.

X. Improved methods to deliver neurotrophic factors and other small
proteins or peptides normally found in the brain.

[]{#__RefHeading___Toc124237000 .anchor}Repair and Plasticity

A. *[Neural Prostheses and Deep Brain Stimulation]{.underline}*.

1\. Design, development, and evaluation of neural recording and
stimulating microelectrodes for neural prostheses and deep brain
stimulation.

2\. Development of thin, insulating coatings to make implanted
electronic packages impervious to the corrosive action of body fluids
and tissues.

3\. Development of transducers of position, touch, and force for use in
functional electrical stimulation systems.

4\. Development of addressable arrays of sub-micron or nano-scale
dimension electrodes for use in the CNS.

5\. Non-invasive methods to focally stimulate small populations of
neurons within the body.

6\. Development of communication aids for individuals with "locked-in
syndrome."

7\. Development of a complete system utilizing existing microelectrodes,
lead wires and telemetry to transfer neural signals outside the body.

8\. Develop new high charge density electrode materials.

9\. Development of a method to repeatedly inhibit neuronal electrical
activity in a safe and effective manner.

10\. Development of a non-invasive method of selectively stimulating
and/or inhibiting small groups of nerve fibers within a nerve trunk.

11\. Development of materials to minimize scarring following surgery in
the central nervous system.

12\. Development of techniques for precise functional placement of
microelectrodes within the central nervous system.

13\. Development of neural controllers to restore micturition and
defecation for individuals with spinal cord lesions.

14\. Development and implementation of automated signal processing
algorithms in hardware or software capable of neural signal analysis for
neural prosthetics applications.

15\. Development of novel nerve cuff electrode or nerve interface
technologies capable of selective stimulation and/or recording from
intact afferent and efferent nerve bundles.

B. *[CNS Trauma and Rehabilitation]{.underline}*.

1\. Means of assisting or achieving restitution of function after injury
to the nervous system.

2\. Develop transgenic, knockout and inducible knockout animal models
for stroke and CNS trauma research.

3\. Develop technology for data gathering and analysis for assessment of
multiple parameters of ICU recording in brain trauma.

4\. Develop instruments or techniques to enhance monitoring of nervous
system activity during surgical procedures, aimed at improving the
safety, targeting or efficacy of those procedures.

5\. Develop new preclinical testing for promising therapies for acute
and chronic central nervous system injury.

6\. Establishment of networks to test pharmaceutical agents in animal
models of CNS trauma.

7\. Development of monitors for such modalities as intracranial
pressure, brain temperature, and cerebral blood flow.

8\. Develop drugs or other agents to reduce scarring after spinal cord
injury.

9\. Develop and test novel biological assays for use as diagnostics in
acute stroke (ischemic vs. hemorrhagic), traumatic brain injury, and
spinal cord injury.

C. *[Neuroimaging]{.underline}*.

1\. Development of ultrasound imaging methods for the central nervous
system.

2\. Develop methods and reagents that allow tracking of grafted cells in
the living host animal using non-invasive imaging methodologies.

3\. Development of imaging techniques to track the course of injury and
repair following spinal cord injury.

D. *[Stem Cell Biology]{.underline}*.

1\. Development of a website and database for posting and discussion of
protocols and best practices used in harvesting, maintaining in culture,
and inducing differentiation of stem cells.

2\. Development of a stem cell repository for the storage of stem cells
from different sources and immortalized cell lines, and for making these
reagents readily available to the research community.

3\. Develop efficient and reproducible methods for harvesting and
storing stem cells for research use.

4\. Develop markers, reagents, and new methodology for the
identification and/or harvesting of stem and progenitor cells in the
nervous system and in other tissues.

5\. Develop methods for phenotyping stem and progenitor cells in the
nervous system.

6\. Use of mutant and transgenic mice or rats to study the effect of
identified genetic alterations on neurogenesis in the adult central
nervous system.

E. *[Axonal Regeneration/Guidance and Synapse Formation]{.underline}*.

1\. Develop biomaterials to serve as paths for supporting or guiding
axonal growth across a site of injury.

2\. Develop methods to deliver neurotrophic factors, cells or genes to
injured brain sites to enhance regeneration or restoration of function.

3\. Develop biomaterials to promote sprouting and directed growth of
axons toward specific sites in the central nervous system.

4\. Develop biomaterials to promote dendritic growth and stability, and
synapse formation in localized areas.

[]{#__RefHeading___Toc124237001 .anchor}Systems and Cognitive
Neuroscience

A. *[Cognitive and Behavioral Neuroscience]{.underline}*.

1\. Development of computerized neuropsychological assessment tools to
facilitate testing of neurologically impaired subjects.

2\. Development of techniques and devices for imaging of small animals
such as transgenic and knockout animal models of complex behaviors.

3\. Design, development, and evaluation of automated systems for
assessment of behavioral parameters.

4\. Development of computer software that integrates imaging and
physiological measures of brain activation.

B. *[Sleep Neuroscience]{.underline}*.

1\. New therapies for sleep disorders.

2\. New methods to categorize sleep stages on line -- especially in
human infants and patients with EEG-distorting brain dysfunction.

3\. New methods for quantifying optimal alertness.

4\. Models of neurological sleep disorders.

5\. Novel applications of evoked potentials to sleep neuroscience.

6\. Further development of portable devices that facilitate
cost-effective screening for potential sleep disorders, and can be used
to monitor the progress of already diagnosed sleep disorders.

7\. Applications of proteomic and/or metabalomic methods to detect sleep
deprivation.

C. *[Pain]{.underline}*.

1\. Development of objective methods for quantitative assessment of
pain, including development of a quantitative sensory testing battery
for pain patients.

2\. Development of novel pain model systems, particularly more accurate
pre-clinical experimental models.

3\. Development of tools to elucidate potential analgesic targets, and
models for testing and validating these for efficacy in patients.

4\. Development of new diagnostic tools for different pain mechanisms
and objective measures of analgesic drug action.

D. *[Neuroimaging]{.underline}*.

1\. Development of devices for artifact-free monitoring of vital
neurological parameters during MRI procedures involving very high static
and dynamic magnetic fields (greater than 2 Tesla) and high-energy
microwave radiation typical of the MRI environment.

2\. Development of functional imaging techniques.

3\. Development of combined imaging strategies, i.e., fMRI and PET.

[]{#__RefHeading___Toc124237002 .anchor}Channels, Synapses and Circuits

A. *[Epilepsy]{.underline}*.

1\. Devices for automated detection and quantification of seizures.

2\. New therapies both for the control of seizures and for the
prevention of the development of epilepsy.

3\. New formulations and delivery systems for antiepileptic drugs.

4\. New models of seizures and epilepsy useful for screening therapies.

5\. Improved methods of monitoring compliance/medication dispensing.

B. *[Muscular Dystrophy]{.underline}*

1\. Development of minimally invasive diagnostic techniques for the
muscular dystrophies.

2\. Development and validation of the role of muscle imaging in
diagnostic evaluation or as a endpoint measure for clinical trials in
muscular dystrophy.

3\. Evaluation of the efficacy of existing anti-inflammatory drugs for
treatment of muscular dystrophy.

4\. Therapeutic drug discovery for the range of muscular dystrophies.

5\. Development of assistive devices for individuals with muscular
dystrophy.

6\. Development of standardized instruments to measure quality of life,
cognitive, and central nervous system function for individuals with
muscular dystrophy.

7\. Development of optimized models for mechanistic studies of specific
muscular dystrophies, including models appropriate for therapeutic
development screens.

8\. Development of cell-based assays that target aspects of pathogenesis
and pathophysiology in the muscular dystrophies, to enable high
throughput drug screening.

9\. Development of high-throughput, small molecule screening efforts for
promising therapeutic targets and identify novel targets for drug
development

10\. Determine the benefits and risks of varied exercise approaches in
muscular dystrophies and develop scientifically based recommendations
concerning optimal exercise, physical activity, and recreation.

11\. Development of strategies to improve vocational outcomes and reduce
social isolation of patients with muscular dystrophy.

[]{#__RefHeading___Toc124237003 .anchor}Neurodegeneration

A. Development and preliminary testing of instruments, devices, or drugs
that enhance diagnostic, treatment, or monitoring capabilities.

B. Identification or development of animal models for research on
neurodegenerative disorders.

C. Development of early or presymptomatic diagnostic procedures for
neurodegenerative disorders.

D. Epidemiology of neurodegenerative disorders.

E. New delivery methods of medications for degenerative neurological
disorders.

F. Development of cell lines for in vitro modeling of neurodegenerative
disorders.

G. Therapeutic drug discovery targeted to neurodegenerative disorders.

H. Development of drug screening assays, including biochemical, cellular
or model organism assays for high-throughput screening approaches.

[]{#__RefHeading___Toc124237004 .anchor}Neural Environment

A. *[Infectious and Immune Disorders]{.underline}*.

1\. Development of therapies to prevent, arrest or reverse autoimmune
neurological disorders such as multiple sclerosis.

2\. Development of methods that aid the diagnostic of infectious and
immune disorders.

3\. Development of methods or vectors for the delivery of biologics
(e.g., cytokines, DNA), drugs, and other agents to the nervous system.

4\. Development and studies of drugs with high blood brain barrier
permeability intended for treatment of CNS infections including
HIV-related opportunistic infections.

5\. Development of animal models for infectious and immune disorders
(e.g., k.o. or transgenic mice, viral systems) that allow the study and
identification of the effect and contribution of genes to disease.

6\. Development of techniques such as microarray, gene expression
analysis or immunological techniques that allow the study and
identification of the effect and contribution of genes to disease or the
effect of therapies.

7\. Development of techniques such as microarray, gene expression
analysis or immunological techniques that allow studies on the
mechanisms and effect of therapies.

8\. Development of functional and other imaging techniques and tools,
and of combinations thereof.

9\. Development and evaluation of biomarkers for infectious and immune
disorders.

B. *[Stroke]{.underline}*.

1\. Development, testing, and evaluation of devices, methods, or drugs
to aid in the prevention, diagnosis and treatment of stroke patients.

2\. Methods for the analysis of protein expression in the ischemic CNS.

3\. Develop and validate large and small animal models, including
transgenic, knockout, and inducible knockout animal resources, that
reflect the complexity and diversity of the human brain and its
responses during ischemia.

4\. Brain specific gene and protein transfer methods that target
cerebral vessels, neurons, and/or glia in the ischemic CNS.

5\. Methods and devices for high throughput genomic and proteomic
expression and data analysis in stroke.

6\. Methods to transiently suppress gene and protein expression in brain
ischemia.

7\. Expand brain imaging capabilities to include new methods of imaging,
synthesis of radiolabeled ligands for specific receptors, and refinement
of functional, structural and metabolic imaging techniques.

8\. Develop bioinformatic databases for stroke to include sharing of
clinical, genomic, and/or proteomic data.

9\. Identify biomarkers for vascular, inflammatory, and immune diseases
of the brain.

10\. Develop and test combination therapies for stroke.

11\. Develop instruments, devices, and methods to enhance drug delivery
through the blood-brain barrier.

C. *[Prion Diseases]{.underline}*.

1\. Development of a rapid and sensitive assay for the detection of
normal and variant prions as well as the detection and isolation of
various prion strains.

2\. Transgenic, knockout and inducible knockout animal resources for
Transmissible Spongiform Encephalopathy research.

[]{#__RefHeading___Toc124237005 .anchor}Technology Development

A. Animal models, including genetic and experimental models of
neurological disorders; examples include mouse mutants, models of spinal
cord injury or traumatic brain injury, epilepsy, and channelopathies.

B. Neuroinformatics, including relational software for genetic,
functional, and anatomical data; databases; and websites for data
sharing.

C. Computational tools for understanding both cellular and systems level
function in the nervous system.

D. Approaches to recording and stimulating neural activity, including
single cells, cellular ensembles, and brain regions or fiber tracts.

E. Imaging tools, including MRI, fMRI, MRS, PET, MEG, optical and
infrared, and ultrasound, both for human and animal studies.

F. Approaches to identify and characterize genes involved in function
and pathology in the nervous system, including microarrays, genetic
linkage methods, mutagenesis, expression analysis, and in situ
localization.

G. Approaches to identify and characterize proteins involved in function
and pathology in the nervous system, including electrophoretic,
immunochemical, and mass spectrometric analyses.

H. Therapeutic drug discovery, including the development of molecular,
cellular, or animal-behavioral screening assays; high-throughput
screening approaches; and preparation of drug candidate chemicals or
chemical libraries by traditional or combinatorial chemical approaches.

I. Bioengineering, including neural prostheses.

[]{#__RefHeading___Toc124237006 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

*[Neurodevelopment and Neurogenetics]{.underline}*

Dr. Robert Finkelstein

Program Director

National Institute of Neurological Disorders and Stoke

\(301\) 496-5745: Fax: (301) 402-1501

Email: <rf45c@nih.gov>

*[Repair and Plasticity]{.underline}*

Dr. Joseph J. Pancrazio

Program Director

National Institute of Neurological Disorders and Stroke

\(301\) 496-1447, Fax: (301) 480-1080

Email: <jp439m@nih.gov>

*[Systems and Cognitive Neuroscience]{.underline}*

Dr. Emmeline Edwards

Program Director

National Institute of Neurological Disorders and Stroke

\(301\) 496-9964, Fax: (301) 480-2424

Email: <ee48r@nih.gov>

*[Channels, Synapses & Circuits]{.underline}*

For program information contact:

Dr. Randall R. Stewart

National Institute of Neurological Disorders and Stroke

\(301\) 496-1917, Fax: (301) 402-1501

Email: <rs416y@nih.gov>

*[Neurodegeneration]{.underline}*

Dr. Eugene J. Oliver

Program Director

National Institute of Neurological Disorders and Stroke

\(301\) 496-5680, Fax: (301) 480-1080

Email: <eo11c@nih.gov>

*[Neural Environment]{.underline}*

Dr. Thomas P. Jacobs

Program Director

National Institute of Neurological Disorders and Stroke

\(301\) 496-1431, Fax: (301) 480-2424

Email: <thomas_jacobs@nih.gov>

*[Technology Development]{.underline}*

Dr. Robert W. Baughman

Associate Director for Technology Development

National Institute of Neurological Disorders and Stroke

\(301\) 496-1779; Fax: (301) 402-1501

Email: <rb175y@nih.gov>

For administrative and business management questions, contact:

Mr. Mike Loewe

Grants Management Officer

National Institute of Neurological Disorders and Stroke

6001 Executive Boulevard, Room 3266

Bethesda, MD 20892

\(301\) 496-5707, Fax: (301) 402-0219

Email: <loewem@mail.nih.gov>

[]{#__RefHeading___Toc124237007 .anchor}National Institute of Nursing
Research (NINR)

The National Institute of Nursing Research (NINR) supports research
focused on biological and behavioral aspects of critical health problems
that confront the Nation. Emphasis is on seeking ways to reduce the
burden of illness and disability by understanding and easing the effects
of acute and chronic illness, improving health-related quality of life
by preventing or delaying the onset of disease or slowing its
progression, establishing better approaches to promote health and
prevent disease, and improving clinical environments by testing
interventions that influence patient health outcomes and reduce costs
and demand for care.

For additional information about areas of interest to the NINR, please
visit our home page at <http://www.nih.gov/ninr/>.

[]{#__RefHeading___Toc124237008 .anchor}Research and Development of
Technologies for Health Promotion and Alleviation, Adaptation to, or
Management of Symptoms

A. Technologies to be used in the hospital, long-term care, hospice,
assisted living facility, or home setting that improve symptom
evaluation in persons with chronic conditions. Conditions of interest
include congestive heart failure, cystic fibrosis, organ failure,
cognitive impairment, renal disease, asthma, diabetes, or mobility
impairments.

B. Devices that improve the acceptance and use of assistive and
monitoring devices, e.g., child peak flow measurement in the home and at
school; nightly use of continuous positive airway pressure (CPAP).

C. Devices to diagnose and screen for COPD early in the course of the
disease, particularly targeting young adults.

D. Technologies to assist in adolescent health promotion and prevention
activities such as smoking cessation devices or obesity prevention
technologies.

E. Devices to assist in providing palliative care for patients with life
threatening illnesses through the disease trajectory whether in active
treatment or at the end of life.

F. Technologies to assist individuals in reducing environmental
exposures, i.e., chemical and viral agents, and indoor/outdoor
allergens.

G. Devices to facilitate resource sharing such as: technologies that
will enable valid and reliable measurement tools/instruments to be
readily available and shared by research scientist focused on similar
issues in a variety of populations.

H. Adaptation of existing or development of new technologies that will
link under-represented populations with available resources to sustain
healthy life styles and eliminate health disparities.

[]{#__RefHeading___Toc124237009 .anchor}Research and Development of
Technologies to Enhance Self Care and Clinical Care

A. Technologies to assist patients to adhere to chronic regimens such as
reminding children to take steroid inhalers during the day for asthma;
alerting obese adults when high calorie and fat content foods are about
to be eaten; adhering to medication regimens; and prompting sedentary
adults to exercise.

B. Devices that improve delivery of care to persons who have restricted
or impaired movement due to (1) conditions of neurological disease or
injury, peripheral vascular disease, rheumatoid disease, or intractable
pain, (2) life sustaining equipment, such as dialysis machines or left
ventricular assist devices, or (3) orthopedic fixation devices.

C. Devices to enable providers and or research scientists to monitor
successful adherence to complex medication regimens (e.g., Highly Active
Anti-Retroviral treatment).

D. Technologies that monitor short and long term self-care behavior
changes.

E. Biological and behavioral monitoring devices for patients in at-risk
and underserved populations in rural and frontier areas that will enable
access to clinical care.

F. Telehealth technologies to improve patient outcomes through
increasing quality, type, and speed of health information sharing, e.g.,
assessing traumatic injury severity at remote sites and transmitting
this information to acute care settings for assessment and evaluation;
communicating signs and symptoms of clients at home to health care
providers in distant locations; tailoring care for diverse patients in a
wide variety of settings, and promoting community interventions to
eliminate health disparities.

G. Technologies to treat chronic wounds that fail to heal, specifically
decubitus ulcers, venous stasis ulcers, and diabetic ulcers.

H. Technologies to be used in the hospital or home care setting to
monitor or assess preterm, low-birth weight or other high-risk infants.

I. Technologies to assist informal caregivers in providing care or
assistance to family members in the home.

J. Noninvasive devices to assess exposure to chemical and viral agents
for children and adults and transmit this information to health care
personnel for assessment and evaluation.

K. Technologies to disseminate research information (i.e., biobehavioral
responses, communication of risk, bioethics) to nurses practicing in
emergency settings and in the community.

[]{#__RefHeading___Toc124237010 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Dr. Paul Cotton

Program Director

National Institute of Nursing Research

\(301\) 402-6423, Fax: (301) 480-8260

Email: <pc272a@nih.gov>

For administrative and business management questions, contact:

Mr. Brian Albertini

Chief, Grants and Contracts Management

National Institute of Nursing Research

Office of Grants and Contracts Management

6701 Democracy Boulevard, Room 710

One Democracy Plaza, MSC 4870

Bethesda, MD 20892-4870

(Courier delivery: Bethesda, MD 20817)

\(301\) 594-6869, Fax: (301) 402-4502

Email: <albertib2@mail.nih.gov>

[]{#__RefHeading___Toc124237011 .anchor}National Center for Research
Resources (NCRR)

NCRR supports primary research to create and develop critical resources,
models, and technologies. NCRR funding also provides biomedical
researchers with access to diverse instrumentation, technologies, basic
and clinical research facilities, animal models, genetic stocks, and
more. These resources enable scientific advances in biomedicine that
lead to lifesaving drugs, devices, and therapies.

For additional information about areas of interest to NCRR, please visit
our home page at [http://www.ncrr.nih.gov](http://www.ncrr.nih.gov/).

[]{#__RefHeading___Toc124237012 .anchor}Research and Development in
Instrumentation and Specialized Technologies for Biomedical Research

A. New or improved instruments, devices, and related methodologies to
facilitate biomedical or behavioral research. Instrumentation includes
but is not limited to mass spectrometry, nuclear magnetic resonance,
fluorescent or kinetic or laser spectroscopies, X-ray absorption/
diffraction, electron or confocal microscopies, and flow cytometry.

B. Development of computer science/technology to study biomedical or
behavioral research problems, e.g., computer visualization, computer
modeling/simulation, structure-based drug design. Development of new
bioinformatics technology infrastructure such as data management and
analysis tools, networking infrastructure and collaborative tool
development.

C. Development of novel technologies for proteomics and glycomics
discovery, e.g., sample handing, separations, mass spectrometry, and
computational tools for protein identification, data curation and
mining.

*[Electron Microscopy, X-ray Diffraction, Other Topics]{.underline}*

Dr. Amy Swain

Division of Biomedical Technology, NCRR

\(301\) 435-0755

Email: <SwainA@mail.nih.gov>

*[NMR, Optical Microscopy, Laser Applications]{.underline}*

Dr. Gregory Farber

Division of Biomedical Technology, NCRR

\(301\) 435-0755;

Email: <FarberG@mail.nih.gov>

*[Proteomics, Mass Spectrometry]{.underline}*

Dr. Douglas Sheeley

Division of Biomedical Technology, NCRR

\(301\) 435-0755

Email: <SheeleyD@mail.nih.gov>

*[Computation, Bioinformatics]{.underline}*

Dr. Carol Bean

Division of Biomedical Technology, NCRR

\(301\) 435-0755

Email: <CaBean@mail.nih.gov>

[]{#__RefHeading___Toc124237013 .anchor}Research and Development in
Comparative Medicine

A. Development of improved reagents and cost-effective methods to
accurately screen and diagnose selected laboratory animal diseases, and
for performing overall assessments of animal quality and health status.
An urgent need currently exists for the development of improved methods
for the detection of active tuberculosis in nonhuman primates.

B. Development of improved reagents and techniques for isolating and
propagating embryonic stem cells (ESC), as well as fetal and adult stem
cells from laboratory animals. Improved methods for causing ESC and
other types of animal stem cells to differentiate along specific
pathways in vitro and in vivo.

C. Development of improved reagents, techniques, and equipment for
isolating, propagating and characterizing specific gene sequences cloned
in bacterial artificial chromosome (BAC) vectors and for preparing and
characterizing BAC libraries made from laboratory animals.

D. Development of improved reagents, techniques and equipment for
preparing and analyzing full-length cDNA libraries made from tissues or
cells of laboratory animals.

E. Development of new technologies to rapidly phenotype large number of
mutant animals.

F. Development of vaccines and new therapeutic agents for the prevention
and/or control of selected laboratory animal diseases. One high priority
need is for the development of methods to control and prevent
Herpesvirus B in nonhuman primates.

G. Development of commercially valuable reagents for lower organisms or
established cell cultures.

H. Development of cost-effective methods for culture and/or preservation
of commercially valuable organisms, including specific types of bacteria
and other microorganisms.

I. Development of cost-effective husbandry and colony management
techniques, equipment, and/or new approaches to improve laboratory
animal welfare and assure efficient and appropriate research use.

J. Design of specialized equipment and caging for laboratory animals to
permit optimal environmental control.

K. Identification, development, and characterization of spontaneous and
engineered vertebrate animal models for studies on various types of
human disease. A need exists for a small animal model of Hepatitis C
virus infection in humans.

L. Development and refinement of new technologies for the effective
cryopreservation and long-term maintenance of laboratory animal embryos,
gametes, and their predecessors.

M. Development of improved reproductive biology techniques (e.g.,
cloning techniques; embryo splitting) to produce genetically identical
laboratory animals.

N. Development of technologies for improved embryo transfer within a
single animal species or of intraspecific embryo transfer to allow
preservation of rare, unique, or endangered animal species that may have
unique value as animal models for human disease.

O. Development of improved reagents, techniques, and equipment for
performing and analyzing the results of microarray experiments.

P. Development and refinement of technologies for the analysis of
regulation of gene expression in a wide range of model organisms,
including non-mammalian species. This could be accomplished by genetic
means (e.g., transgenesis, conditional knock-out or knock-in) or
epigenetic means (e.g., morphilinos, RNAi).

Dr. Franziska B. Grieder

Comparative Medicine, NCRR

\(301\) 435-0746, Fax: (301) 480-3819

Email: <fg45v@nih.gov>

[]{#__RefHeading___Toc124237014 .anchor}Clinical Technology Applications

A. Development of patient-oriented research technologies. This includes
therapies, diagnostics, sensors, and imaging technologies used for
patient diagnosis, monitoring, and treatment.

B. Diversification of methods used for clinical studies of disease
states, such as micro-analytical sensors or imaging devices.

C. Miniaturization of existing biomedical technologies for adaptation to
pediatric use.

D. Development of artificial tissues and organs for medical use.
Development of transplant technologies and human cell isolation
techniques.

E. Development of vehicles for drug delivery, including for patient
groups with a potential for altered pharmacology or compliance, such as
children or the elderly.

F. Development of bioinformatics technology: (1) collection, collation,
and archiving of databases; (2) assuring compatibility with other
databases; (3) protected storage and transmission of confidential
medical data; and (4) software which facilitates the review or
implementation of clinical trial protocols; (5) software and hardware
applicable to tying in data from multiple and simultaneous clinical
protocols across multiple clinical sites; and 6) methods and
instrumentation to support clinical imaging data.

G. Development of vectors for gene therapy, with improved means of: (1)
targeting specific cells and/or tissues; (2) transduction and
expression; (3) delivery to patients; and/or (4) production and
purification.

H. Development of high throughput technologies for studies of human
diseases and methods and techniques for the analyses, storage, and
interpretation of accumulated data.

I. Development of techniques, instruments and reagents to optimize the
recovery and quality of cells obtained from vertebrate and human organs
for subsequent use in either basic research or clinical protocols.

J. Development of techniques, instruments, reagents and vector systems
for use in clinical gene therapy protocols.

Dr. Anthony Hayward

Clinical Research, NCRR

\(301\) 435-0790, Fax: (301) 480-3661

Email: <haywarda@mail.nih.gov>

[]{#__RefHeading___Toc124237015 .anchor}Development of
Discovery-Oriented Software and Tools for Science Education

Development of new discovery-oriented educational software and the
application of educational technology and tools for education on health
science topics that targets K through 12 students and undergraduate
students are sought. Topics can range from basic molecular and cellular
biology to human diseases. Development of this software may be directed
toward the adaptation of existing or recently developed educational
programs for interactive learning. This effort is intended to yield
efficient and user-friendly educational units for K-12 and undergraduate
students that can be extended to enhance the health science literacy of
the general public. A broad dissemination is strongly encouraged.

Dr. Krishan Arora

Research Infrastructure, NCRR

\(301\) 435-0788, Fax: (301) 480-3770

Email: <ka31@nih.gov>

[]{#__RefHeading___Toc124237016 .anchor}Other Research Topic(s) Within
the Mission of the Center

For additional information on research topics, contact:

Dr. Louise Ramm

Deputy Director

National Center for Research Resources

\(301\) 435-0879, Fax: (301) 480-3658

Email: <lr34m@nih.gov>

For administrative and business management questions, contact:

Ms. Holly Atherton

National Center for Research Resources

\(301\) 435-0840, Fax: (301) 480-3777

Email: <athertoh@mail.nih.gov>

[]{#__RefHeading___Toc124237017 .anchor}National Center for
Complementary and Alternative Medicine (NCCAM)

The mission of the National Center for Complementary and Alternative
Medicine (NCCAM) is to explore complementary and alternative healing
practices in the context of rigorous science; educate and train
complementary and alternative medicine (CAM) researchers; and
disseminate authoritative information to the public and professionals.
CAM encompasses those healthcare and medical practices that are not
currently an integral part of conventional medicine. The list of
practices that are considered CAM changes continually as CAM practices
and therapies that are proven safe and effective become accepted as
\"mainstream\" healthcare practices. NCCAM groups these practices within
four major domains of mind-body medicine (for example, meditation),
biologically based practices (for example, herbal therapies, special
diets), manipulative and body-based practices (for example,
chiropractic, massage), and energy medicine (for example, Reiki, Qi
gong). In addition, NCCAM also studies whole medical systems (for
example, Traditional Chinese Medicine, Ayurveda). For a detailed
description of NCCAM mission, please see
<http://nccam.nih.gov/about/plans/2005/index.htm>.

The following narrative indicates the scope of projects suitable for the
SBIR/STTR program that fit within the mission of NCCAM. For additional
information about areas of interest to NCCAM and a listing of NCCAM's
currently funded applications, please visit
<http://www.nccam.nih.gov/research>. Business concerns interested in
exploring SBIR/STTR grant opportunities with NCCAM are encouraged to
contact the NCCAM representatives prior to submitting an application.

[]{#__RefHeading___Toc124237018 .anchor}Technology Development and
Research

NCCAM encourages innovative technological research and development of
commercializable CAM products that would fulfill the mission of NCCAM.
The application may include basic, pre-clinical, and early phase
clinical studies that can ultimately lead to a commercial CAM product.
The areas of interest to NCCAM include but are not limited to:

-   Develop and validate methods for standardization and
    characterization of active ingredients in natural products;

-   Develop and validate CAM methodology to enhance vaccine efficacy;

-   Develop and validate methods for standardization and
    characterization of active components of mind-body interventions;

-   Develop and validate devices for measurements of putative healing
    energies;

-   Develop and validate biomarkers for measurement of stress for
    studying efficacy of mind-body therapies;

-   Develop and validate standardized and reliable surrogate markers of
    brain states that correlate with brain imaging;

-   Develop and validate technical imaging tools or instruments for
    studying manipulative therapies;

-   Develop tools for pain management that are not conventionally
    accepted;

-   Develop and validate unconventional devices for diagnosis and
    treatment; and

-   Develop standardized, research-grade natural products including
    engineering of new probiotics. For biologically active agents, the
    applicant should pay particular attention to the NCCAM policy and
    guidance at [http://nccam.nih.gov/research/policies/
    bioactive.htm](http://nccam.nih.gov/research/policies/bioactive.htm).

[]{#__RefHeading___Toc124237019 .anchor}Topics That Are of Little or No
Interest to NCCAM

The NCCAM Office of Communications is responsible for disseminating CAM
information to the public. Therefore, applications addressing database
creation or maintenance of any kind, software development, or
educational materials or courses (e.g., CD's, CME's) will not be
considered relevant to the NCCAM SBIR/STTR program. Included are
cookbooks of special diets and software or instructional materials for
treatment of diseases. The NCCAM will also not support clinical practice
of any kind.

[]{#__RefHeading___Toc124237020 .anchor}Other Research Topic(s) Within
the Mission of the Center

For additional information on research topics, please contact:

Dr. Carol Pontzer

Program Officer

National Center for Complementary and Alternative Medicine

6707 Democracy Blvd.

Suite 401, MSC 5475

Bethesda, MD 20892-5475

\(301\) 435-6286, Fax: (301) 480-3621

Email: <pontzerc@mail.nih.gov>

For administrative, business management, and grant policy questions,
please contact:

Mr. George Tucker, M.B.A.

Grants Management Officer

6707 Democracy Blvd.

Suite 401, MSC 5475

Bethesda, MD 20892-5475

\(301\) 594-8853, Fax: (301) 480-1552

Email: <gt35v@nih.gov>

[]{#__RefHeading___Toc124237021 .anchor}National Center on Minority
Health and Health Disparities (NCMHD)

The mission of the National Center on Minority Health and Health
Disparities (NCMHD) is to promote minority health and to lead,
coordinate, support, and assess the National Institutes of Health (NIH)
effort to reduce and ultimately eliminate health disparities. In this
effort, the NCMHD conducts and supports basic, clinical, social and
behavioral research, facilitates the development of research
infrastructure and training, fosters emerging programs, and reaches out
to racial/ethnic minority and other health disparity communities.

NCMHD particularly serves as the focal point for targeted,
hypothesis-driven, patient-oriented research and targeted applied,
outcomes- and problem-driven studies that meet at least two of three
criteria: (1) participating health disparity population(s) is/are over
sampled; (2) the participating health disparity population(s) is/are
specifically targeted with or without within-group comparisons; and/or
(3) the research focus is within the scope of NCMHD programmatic
interests. NCMHD's programmatic interests include surveillance,
explanatory, and translational research in health disparity populations.
Specific topics include health promotion and disease prevention and
intervention; pathogenic mechanisms underlying escalations in the
susceptibility to disease and illness; and health services research -
the impact of socioeconomic, cultural, and other environmental factors
on health outcomes.

Program Areas of Interest

[]{#__RefHeading___Toc124237022 .anchor}Natural History of Disparities
in Health Outcomes

Disparities in health outcomes are believed to result from the
interaction of a plethora of interactive factors such as environmental
exposures and genetic traits, and/or the accrual over time of stable
phenotypic traits and lifestyle behaviors that contribute to but are
insufficient individually to cause the onset of disease or illness. The
etiology of disparities in health outcomes with particular emphasis on
identifying and deconstructing the array of interactive risk
factors---environmental, socioeconomic, stereotyping, bias, clinical
uncertainty, and gene-related factors---that contribute to escalations
in the susceptibility to disease and illness and may contribute to
health disparities. Examples include, but are not limited to:

1\. Multidisciplinary basic research approaches that lead to biological
probes and starting points for therapeutic interventions;

2\. Innovative high throughput screening approaches to identify
compounds that are active in target- and phenotype assays and to use
these approaches to develop bioactive probes for application in vitro
and potentially in vivo studies;

3\. Methodological and technological innovation that will integrate
behavioral and social science with biomedical research, including gene
related and environmental components.

4\. Differential pharmacologic drug metabolism; and

5\. Impact of dietary decision making in diverse populations and effect
on health disparity outcomes.

[]{#__RefHeading___Toc124237023 .anchor}Health Promotion and Prevention
Research in the Health Disparities Communities

High priority is given to activities designed to empower health
disparity communities to achieve health equity through health education,
disease prevention, and partnering in community-based hypothesis,
outcomes- and problem-driven research. Examples of such activities
include, but are not limited to:

6\. Efficacy of therapies in local populations;

7\. Motivating positive behavioral changes in diverse populations;

8\. Health outcomes related to health seeking, lifestyle, risk taking,
protective behaviors and/or socioeconomic status;

9\. Incorporating research into health promotion and disease prevention
initiatives, applying new knowledge in a culturally appropriate manner
in intervention/disease prevention initiatives; and

10\. Distribution of health structures and adverse health effects, and
the sufficiency of healthcare frameworks in accommodating diverse
social, cultural, political and economic factors.

[]{#__RefHeading___Toc124237024 .anchor}Innovations in Health
Disparities Research

Studies that promote and advance evidence-based transformation in
medical decision-making and health policy; demonstration projects that
implement evidence-based, culturally sensitive intervention/disease
prevention therapies and diagnostics; and activities designed to build
capacity for health disparities research are of high priority. Examples
of such studies include, but are not limited to:

11\. Development of health disparity group-specific methodologies and
diagnostics;

12\. Development of technologies targeted for health disparity groups
(i.e., gene chips, other novel assay systems, animal models, specialized
instruments, etc.); and

13\. Demonstration projects that build capacity for health disparities
research (e.g., regional hospital-based registries for disease areas of
emphasis, etc.) or implement the translation/application of research
results in a culturally sensitive manner.

For additional information about the areas of interest to the NCMHD,
please visit our home page at
[http://www.ncmhd.nih.gov](http://www.ncmhd.nih.gov/).

[]{#__RefHeading___Toc124237025 .anchor}Broad Area of Research that we
Support

Studies on the biological and biobehavioral risk factors for disparities
in health and health outcomes; cultural, environmental, and societal
dimensions of disparities in health status, including the impact of
health processes; development and refinement of research tools, survey
instruments, and databases that are culturally sensitive and
specifically for racial and ethnic minority populations and other health
disparity populations, in particular the medically underserved which
includes the rural and urban poor.

For additional information on research topics, contact:

Mr. Vincent A. Thomas, Jr., MSW, MPA

National Center on Minority Health and Health Disparities, NIH

6707 Democracy Blvd.

Suite 800, MSC 5465

Bethesda, MD 20892-5465

\(301\) 402-2516, Fax: (301) 480-4049

Email: <vt5e@nih.gov>

For administrative and business management questions, contract:

Mr. Bryan Clark, MBA

Grants Management Officer

National Center on Minority Health and Health Disparities, NIH

6707 Democracy Blvd.

Suite 800, MSC 5465

Bethesda, MD 20892-5465

\(301\) 594-8412, Fax: (301) 480-4049

Email: <clarkb@od.nih.gov>

[]{#__RefHeading___Toc124237026 .anchor}National Library of Medicine
(NLM)

The NLM supports research and development projects in biomedical
informatics and bioinformatics. NLM defines biomedical informatics as
the intersection of basic informational and computing sciences with a
wide range of application domains in biomedicine and public health.
Bioinformatics is the intersection of basic informational and computing
sciences with the biological sciences.

For additional information about areas of interest to the NLM, please
visit our home page at <http://www.nlm.nih.gov/ep>.

[]{#__RefHeading___Toc124237027 .anchor}Biomedical Informatics

There are broad needs for informatics concepts, tools and systems to
manage the information of health care delivery, reduce medical errors,
provide decision support for clinicians, extract outcome and public
health information from large datasets, and predict health events.

To support such projects, NLM is interested in:

A. Mechanisms to capture and integrate new information into existing
knowledge bases, including integration of heterogeneous data sets.

B. Approaches for retrieving, extracting and analyzing data from large
health-related and heterogeneous databases, such as patient data,
population health data, or image databases.

C. Systems, devices, or programs that facilitate utilization of
electronic medical record systems in clinical practice, for such
functions as chart entry, decision support, reduction of errors.

D. Systems, devices, or programs that facilitate utilization of
electronic record systems and tools in public health, for such functions
as syndromic surveillance and trend analysis.

E. Projects relevant to the informatics of disaster management,
including management and delivery of information in disaster settings.

[]{#__RefHeading___Toc124237028 .anchor}Bioinformatics

High through-put scientific research has greatly increased the volume of
research data and has magnified the problem of information management
and interpretation.

To help manage such data, NLM is interested in:

A. Software algorithms and database query methods capable of capturing
scientific data from published knowledge sources or multiple related
factual databases.

B. Tools for data management and analysis for genetic linkage mapping,
physical mapping, DNA sequencing, and proteomics.

C. Tools and systems for bringing \"bench to bedside,\" applying
research data to clinical problems.

D. Algorithms capable of predicting structure and/or function in model
biological systems.

E. Algorithms capable of enhanced computational modeling of biological,
biomedical and behavioral sciences data at multiple scales of research,
ranging from molecular to population.

[]{#__RefHeading___Toc124237029 .anchor}Other Research Topic(s) Within
the Mission of NLM by pre-arrangement with NLM Program Staff

For additional information on research topics, contact:

Hua-Chuan Sim, M.D.

Program Officer

Division of Extramural Programs

National Library of Medicine

\(301\) 496-4253, Fax: (301) 402-2952

Email: <simh@mail.nih.gov>

For administrative and business management questions, contact:

Mr. Dwight Mowery

Grants Management Officer

Extramural Programs Division

National Library of Medicine

\(301\) 496-4221, Fax: (301) 402-0421

Email: <moweryd@mail.nih.gov>

[]{#__RefHeading___Toc124237030 .anchor}CENTERS FOR DISEASE CONTROL AND
PREVENTION (CDC)

CDC will accept SBIR grant applications on the April 1, August 1, and
December 1, 2006 submission dates.

The CDC serves as the national focus for developing and applying disease
prevention and control, environmental health and health promotion and
health education activities designed to improve the health of the people
of the United States. To accomplish its mission, CDC identifies and
defines preventable health problems and maintains active surveillance of
diseases through epidemiologic and laboratory investigations and data
collection, analysis, and distribution; serves as the PHS lead agency in
developing and implementing operational research aimed at developing and
testing effective disease prevention, control and health promotion
programs; administers a national program to develop recommended
occupational safety and health standards and to conduct research,
training, and technical assistance to assure safe and healthful working
conditions for every working person; develops and implements a program
to sustain a strong national workforce in disease prevention and
control; conducts a national program for improving the performance of
clinical laboratories; and develops programs to prevent premature death
and avoidable illness and disability caused by noninfectious,
non-occupational environmental and related factors.

CDC is responsible for controlling the induction and spread of
infectious diseases, and provides consultation and assistance to other
nations and international agencies to assist in improving their disease
prevention and control, environmental health, and health promotion
activities.

For additional information about areas of interest to the CDC, please
visit our home page at [http://www.cdc.gov](http://www.cdc.gov/).

[]{#__RefHeading___Toc124237031 .anchor}National Center on Birth Defects
and Developmental Disabilities (NCBDDD)

The National Center on Birth Defects and Developmental Disabilities at
the Centers for Disease Control and Prevention seeks to promote optimal
fetal, infant, and child development; prevent birth defects and
childhood developmental disabilities; and enhance the quality of life
and prevent secondary conditions among children, adolescents, and adults
who are living with a disability.

The NCBDDD areas of interest focus on:

A. Develop, produce and evaluate the effectiveness of educational
modules for birth defects prevention.

B. Develop, produce and evaluate the effectiveness of educational
modules with the goal of preventing developmental disabilities.

C. Develop and evaluate assistive technology for promoting and
maintaining health and reducing secondary conditions.

D. Develop and evaluate tools, modules or materials to identify children
with developmental problems including developmental and early hearing
screening.

[]{#__RefHeading___Toc124237032 .anchor}Other Research Topic(s) Within
the Mission of the Center

For additional information on research topics, contact:

Dr. Don Lollar

Acting Director, Office of Extramural Research

404-498-3041

Email: <dlollar@cdc.gov>

or

Lisa Garbarino

Public Health Analyst

\(404\) 498-3979

Email: <lgarbarino@cdc.gov>

For administrative and business information, contact:

Mr. Curtis Bryant, Small Business Specialist

Dept. of Health and Human Services

Office of Small and Disadvantaged Business Utilization, supporting CDC

Mail Stop E14

2920 Brandywine Road

Atlanta, Georgia 30341

\(770\) 488-2806, Fax: (770) 488-2828

Email: <ckb9@cdc.gov>

For grants specific information, contact:

Ms. Nealen Austin

Centers for Disease Control and Prevention

Procurement and Grants Office

Mail Stop E-09

2920 Brandywine Road

Atlanta, Georgia 30341

\(770\) 488-2722, Fax: (770) 488-2777

Email: <naustin@cdc.gov>

[]{#__RefHeading___Toc124237033 .anchor}National Center for Chronic
Disease Prevention and Health Promotion (NCCDPHP)

The NCCDPHP plans, directs, and coordinates programs in health
promotion, chronic disease prevention, and reproductive health to
enhance quality of life, improve reproductive health, and reduce the
incidence of heart disease, stroke, cancer, diabetes, arthritis,
obesity, oral disease, infant and maternal morbidity and mortality,
unintended pregnancy, and emerging chronic diseases. NCCDPHP uses two
essential criteria to prioritize its research portfolio, societal burden
and disproportionate burden. NCCDPHP places high priority on chronic
diseases and conditions and reproductive health outcomes that have the
greatest total impact on health, longevity, and quality of life. NCCDPHP
places high priority on eliminating disproportionate burden related to
sex, age, race, ethnicity, geography, sexual orientation, socioeconomic
status, disability, and special needs. NCCDPHP supports three primary
types of applied research, research on cause (determinant research),
research on effect (intervention research), and research on application
and benefit (dissemination research). NCCDPHP emphasizes cross-cutting
research that is participatory, accounts for social and ecological
factors, and is implemented at multiple levels.

NCCDPHP has identified ten priority research areas: (1) develop new
measures and research designs to strengthen the quality of research; (2)
identify the underlying determinants of racial and ethnic health
disparities; (3) develop and evaluate interventions to eliminate health
disparities; (4) examine established and emerging risk factors for
chronic disease and investigate their potential for public health
interventions; (5) assess the effectiveness of policy and environmental
interventions to promote health; (6) improve the processes and outcomes
of health care systems; (7) develop effective communication strategies
to promote health; (8) examine methods for helping people manage their
own health; (9) develop and evaluate the effectiveness of
population-based health promotion and disease prevention policies and
programs at the local, state, national, and international levels; (10)
examine approaches for effectively translating successful community
interventions into widespread practice. For examples of specific
research questions in each of the ten priority areas, see *[Setting the
Agenda: CDC Research in Chronic Disease Prevention and Health
Promotion]{.underline}*, available at
[[http://www.cdc.gov/nccdphp/agenda/index.htm]{.underline}](http://www.cdc.gov/nccdphp/agenda/index.htm).

For technical information on research topics, contact:

Brenda Colley Gilbert, Ph.D., MSPH

Acting Deputy Associate Director for Extramural Research

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

Mail Stop K92

4770 Buford Highway, NE Atlanta, GA 30341

\(770\) 488-8390, Fax: (770) 488-8046

[]{#__RefHeading___Toc124237034 .anchor}Division of Cancer Prevention
and Control

The National Center for Chronic Disease Prevention and Health Promotion
supports a national program to prevent premature death and disability
from chronic diseases and to promote healthy personal behaviors. Within
the Center, the Division of Cancer Prevention and Control supports
comprehensive cancer surveillance, epidemiologic, health and behavioral
science research, communications and program services to reduce the
illness and death associated with cancer.

Division of Cancer Prevention

The Cancer Surveillance Branch of the Division of Cancer Prevention and
Control supports Cancer Registration activities in population based
cancer registries. This national program with its partners encompasses
the entire research, evaluation, collection, and analysis phases of
cancer surveillance data for use in comprehensive cancer control plans.

A. Promote the advancement and utilization of real-time standardized
computerized interfacing from Hospital Registry systems to medical
record data sources and to Population based cancer surveillance systems.
Activities would include improve the communication and computerized
interface technology such as the establishment of Virtual Private
Network, and secure Internet technologies to facilitate the secure
reporting of data from providing organizations; innovations and
application of mapping of local codes to national clinically relevant
standard codes (such as LOINC and SNOMED) and vice-versa; advancement in
the use of standardized reporting structures such as Health Level 7
(HL7) standards and Extensible Markup Language (XML).

B. Develop innovative presentation of cancer research and surveillance
data such as graphical information systems for the analysis of data, and
improved innovation in the design and use of management reports.

C. Promote the advancement and development of integrated person centered
data repository with other appropriate data systems applying cancer
registry data and other disease registries and vital records data.

D. Develop innovative and automated computerized data quality
improvements, such as the application of intelligent business rules for
use in cancer registry applications. Such that when modification are
adjusted to a patients cancer abstract all necessary modifications are
done based on appropriate automatic quality control checks.

E. Promote the development of probabilistic matching models for
auto-encoding of narrative text based medical records sources such as
narrative pathology, endoscopy, or surgery reports to standardized
reporting codes.

Ken Gerlach, MPH

Health Scientist

Centers for Disease Control and Prevention (CDC)

Division of Cancer Prevention and Control (DCPC)

4770 Buford Highway, NE, MS K-53

Atlanta, GA 30341

\(770\) 488-3008, Fax: (770) 488-4759

Email: <Kgerlach@cdc.gov>

*[FedEx Address]{.underline}*:

The Koger Center

2858 Woodcock Blvd.

Davidson Bldg, Rm 3513

Chamblee, GA 30341

Breast Cancer Early Detection

The Breast and Cervical Cancer Early Detection Program in the Division
of Cancer Prevention and Control is a national program to coordinate and
improve the delivery of comprehensive breast and cervical cancer
screening and diagnostic services to low income women who lack the
income or insurance coverage necessary to participate in these
potentially lifesaving procedures, with an emphasis on reaching women
from minority populations who are less likely to have access to or
participate in them. Breast cancer screening is directed to women age 40
and older. Women diagnosed with breast cancer are most likely to survive
when their disease is detected at a very early stage.

Early detection is primarily a function of routine mammography and
expert interpretation. In the U.S., a clinical breast examination (CBE)
is considered part of the screening process. Clinical breast examination
can provide useful information to the radiologic technician and the
mammographer concerning areas of the breast that should receive special
attention in imaging, or conditions that may suggest alternate
techniques of imaging. Practitioners being trained to do CBE frequently
use synthetic breast models to simulate examinations. These models are
typically representative of relatively dense breasts, and they are
modest in size. Opportunities exist to improve the skills of clinicians
in examining breasts by making available a wider variety of models that
reflect both larger breasts and tissue more typical of post-menopausal
women.

Applicants would propose a plan to identify existing models, document
gaps, and create models to fill those gaps. Phase two of the proposal
would present a plan to market/disseminate the models and evaluate their
impact on the practice of CBE.

For programmatic information, contact:

Ms. Judy Hannan

Training and Communication Team

Division of Cancer Prevention and Control

Mailstop K-57

4770 Buford Highway, NE

Atlanta, GA 30341

770-488-4880, Fax: 770-488-3230

Email: <JudyHannan@cdc.gov>

[]{#__RefHeading___Toc124237035 .anchor}Division of Adult and Community
Health

The mission of the Division of Adult and Community Health, NCCDPHP, has
seven major components:

1\. ***[Aging.]{.underline}*** CDC has established national, state-based
programs targeting cardiovascular disease, diabetes, cancer, arthritis,
injuries, and immunization. CDC\'s unique expertise can be readily
applied to target the health needs of older Americans by providing
public health leadership and coordination, by enhancing surveillance,
and by putting research to work for older Americans.

2\. ***[BRFSS.]{.underline}*** The Behavioral Risk Factor Surveillance
System (BRFSS), the world\'s largest on-going telephone survey, tracks
health and behavioral risk factors in the United States, including all
50 states, the District of Columbia, Puerto Rico, Guam, and the Virgin
Islands. BRFSS is one of the leading innovators of survey research
methods and approaches, including the uses of mixed-mode surveys,
addressing changes in telecommunications technology such as cell phones,
and surveying hard-to-reach racial and ethnic groups.

3\. ***[Cardiovascular Health.]{.underline}*** Heart disease and stroke
are the first and third leading killers of Americans and are leading
causes of disability in the US. Cardiovascular diseases cost an
estimated \$368 billion in 2003. High blood pressure and high blood
cholesterol, major risk factors for heart diseases and stroke, are
prevalent in the US population yet are preventable and controllable.
CDC\'s cardiovascular health program mission is to provide public health
leadership to improve cardiovascular health for all, reduce the burden,
and eliminate disparities associated with heart disease and stroke.

4\. ***[Health-Related Quality of Life Surveillance.]{.underline}*** In
public health and medicine, the concept of health-related quality of
life refers to a person\'s or group\'s perceived physical and mental
health over time. Tracking health-related quality of life in different
populations can identify subgroups with poor physical or mental health
and can help guide policies or interventions to improve their health.

5\. ***[Prevention Research Centers.]{.underline}*** The PRC Program is
a network of academic centers, public health agencies, nonprofit
organizations, and community partners that strives to improve health
promotion and disease prevention efforts. The centers, which focus on
high-priority public health issues, work to bridge gaps between
scientific knowledge and public health practice. The network translates
promising research findings into practical and effective programs and
policies for use in communities throughout the nation.

For programmatic information, contact:

Mike Waller

Deputy Director

Division of Adult and Community Health

Mailstop K-45

4770 Buford Highway, NE

Atlanta, GA 30341

\(770\) 488-5269, Fax: (770) 488-5964

Email: <mnw1@cdc.gov>

[]{#__RefHeading___Toc124237036 .anchor}Division of Nutrition and
Physical Activity

The Division of Nutrition and Physical Activity is partnering with the
National Cancer Institute (NCI), the Produce for Better Health
Foundation (PBH), the United States Department of Agriculture (USDA),
the American Cancer Society (ACS), and others on the 5 A Day for Better
Health Program, an initiative to increase American's intake of fruit and
vegetables. High intake of fruit and vegetables has been associated with
reduced risk of cardiovascular disease, many cancers, as well as other
chronic diseases and conditions. Further, over consumption of food
combined with lack of physical activity is creating an epidemic of
overweight and obesity in the United States. Opportunities exist to
prevent or reduce the burden of many chronic diseases by increasing
knowledge of nutrition, increasing availability of and access to healthy
foods, and changing policies to promote healthful choices.

Chronic Disease Nutrition

There is interest in the development, dissemination, and evaluation of
innovative methods to increase knowledge of healthful nutrition
practices including increased fruit and vegetable intake, decreased fat
intake, and decreased caloric consumption among persons of many
different backgrounds and at different stages of life. Although
effective strategies for nutrition education exist, few have been
disseminated to a larger audience than the original research population.
The focus of proposed projects should reflect target populations at high
risk of developing nutrition related chronic diseases. There is also
interest in the development of nutrition intervention programs that are
targeted toward changing the environment or policies that affect
people's food choices. Most nutrition interventions provide nutrition
education for individual dietary change but do not change the
environment or policies that affect a population's access to healthful
foods. Some limited research has examined how the availability of and
access to fruit and vegetables impacts consumption. Environmental and
policy interventions to increase availability and reduce prices of fruit
and vegetables have been effective in the short-term. Few of the
interventions have lasted long enough to determine whether increased
consumption could be sustained over the long-term.

A. Use of innovative or new strategies to promote health.

1\. Design and develop an innovative series of educational tools (i.e.
audiovisuals, series of lunch and learns) for a worksite health
promotion program that incorporates both the volumetrics/energy density
principles as well as the promotion of fruits and vegetables. The
educational series should clearly define the benefits of eating fruits
and vegetables and explain the volumetrics/energy density eating
concept. In addition, it should be emphasized that replacing high-energy
dense foods for low-energy dense foods can help a person eat fewer
calories. Some examples of educational tools include a video on shopping
for and preparing food; a video on the principles of Volumetrics with
specific examples of varying levels of energy density in foods; a
supermarket tour guide (with an emphasis on fruits and vegetables); a
video or booklet on how recipes can be modified to incorporate fruits,
vegetables and low-energy dense foods; as series of lunch and learns
with handouts. A successful intervention should target the specific
population -- working adults who have little time to think about,
prepare and cook meals. In addition, the tools should reach different
ethnic and socioeconomic groups. This program should be supported at
work but also translatable into the employee's everyday life both at
home and away from home. Coordination on this project with CDC's 5 A Day
Program is strongly encouraged for a successful outcome.

2\. Design, develop, and evaluate methods to encourage purchase of
simple, time saving, fresh, and good tasting healthful food items in
supermarkets, convenience stores, or other locations. Some examples of
supermarket methods include dinner of the day (i.e., a rack that
conveniently contains all items needed for a healthy meal including
recipe information), convenience meals, or healthy children's lunch
packs. Some examples of convenience store methods include a rack at the
front counter containing individually wrapped snack packs or items
packaged to be eaten on the go (e.g., a fruit cup with spoon that can
fit in an automobile drink holder). Coordination on this project with
CDC's 5 A Day Program is strongly encouraged for a successful outcome.

3\. Design, develop, and evaluate innovative food service alternatives
for use at schools, colleges, workplaces, or other locations. Some
examples include smoothie bars, mobile salad bars, burrito or pasta
bars, vending machine alternatives, or other similar options. Several of
these food service alternatives have been tried in school systems and
worksites across the country. This program should incorporate and
promote increased consumption of fruits and vegetables. Examples to
follow include the Santa Monica Farmer's Market Salad Bar Program,
innovative changes in food service in the Los Angeles County School
System, Chefs in schools and successful research interventions that
changed availability and pricing in school or workplace cafeterias and
vending machines. Coordination on this project with CDC's 5 A Day
Program is strongly encouraged for a successful outcome.

4\. Design, develop, and evaluate (pilot test) a comprehensive
educational strategy/program with school aged children and young adults
(preschool to college) that focuses on increased vegetable and fruit
consumption. This comprehensive educational strategy/program may be
school or community based. It should be interdisciplinary, have a
multi-dimensional approach, be theory based and generalizable.
Partnering is encouraged with those entities interested in improving
community health. Innovations may include interventions in other youth
organizations or programs such as Boy and Girl Scouts, 4-H Boys and
Girls Clubs, YMCA, and college groups. Coordination on this project with
CDC's 5 A Day Program is strongly encouraged for a successful outcome.

5\. Environmental change interventions can be an effective way to
support a community effort to increase community vegetable and fruit
intake. Design, implement, and evaluate an environmental change
intervention incorporating 5 A Day. This intervention should be an
educational and ecological effort emphasizing such factors as access to
vegetables and fruits, cost/pricing of vegetables and fruits, and
point-of-purchase education. Behavior-specific ecological models should
be used to guide this intervention. This intervention may use innovative
methodology and partnering to facilitate consumption of vegetables and
fruits (examples include: strategies for edible trails, Jr. Master
Gardener projects, (Senior) farmers markets and/or school and community
gardens).

6\. Design, develop and evaluate a prototype 5 A Day program that
addresses the motivational factors influencing American adolescent
decision making in terms of nutrition-related behaviors. The 5 A Day
message is clearly not getting through to America's adolescents. Most 5
A Day programs seem to target either children or adults, with little
attention paid to the teenager. Informational websites are either loaded
with dry facts aimed at adults, or contain child-oriented themes, using
animated fruit and vegetable characters, very simple games, or novelty
songs to entice children to change their dietary habits. What about all
the adolescents who have already developed poor dietary habits and
perceptions? This program should address/ determine specifically how
adolescent *nutrition-related* perceptions are formed, what it takes to
change these perceptions, how adolescents view existing nutritional
programs (and nutrition in general), and most importantly, how to create
a positive change in adolescent dietary habits. Coordination on this
project with CDC's 5 A Day Program is strongly encouraged for a
successful outcome.

For programmatic information, contact:

Mary Kay Solera, M.S., C.H.E.S.

National Center for Chronic Disease Prevention and Health Promotion

Mailstop K-26

3005 Chamblee-Tucker Road

Atlanta, GA 30341

\(770\) 488-5291, Fax: (770) 488-6027

Email: <zmt7@cdc.gov>

Physical Activity and Health

Regular physical activity has a positive impact on numerous health
outcomes. As such, the accurate measurement of individual physical
activity behaviors is important for both surveillance and research.

Applications are invited for the development of innovative technological
strategies and methods for improving the validity and reliability of
self-reported physical activity behaviors. Of interest is the
development and validation of technological tools that will allow
qualification of the CDC/ACSM physical activity recommendations of
individual behaviors. The product should improve upon current survey or
diary methods as they relate to: a) the recall and reporting of specific
activities, frequency, intensity, duration and/or b) respondent burden.
Examples of technological tools could include, but are not limited to,
software for hand-held electronic devices for individually-tailored
survey assessment, software for assessment that is aided by video
examples of physical activity behaviors, and software for improved
physical activity diaries. Development of such tools will allow for
better measurement of physical activity for surveillance and research.

For programmatic information, contact:

Harold W. Kohl, III, Ph.D.

National Center for Chronic Disease Prevention and Health Promotion

Mailstop K-46

3005 Chamblee-Tucker Road

Atlanta, GA 30341

\(770\) 488-5481, Fax: (770) 488-5473

Email: <hek0@cdc.gov>

[]{#__RefHeading___Toc124237037 .anchor}Division of Oral Health

The Division of Oral Health seeks to improve the oral health of the
nation by extending the use of proven strategies to prevent oral
diseases, enhancing surveillance of oral diseases, strengthening the
nation's oral health infrastructure, and guiding infection control in
dentistry. At the core of the DOH mission is the critical relationship
between oral health and general health and well-being. Division programs
focus on educating the public, public health and clinical professionals,
and policy makers on steps that individuals and communities can take to
improve oral health at different ages throughout the lifespan, and
serving as a resource for these efforts.

A. Providing Safe Dental Care

Infection control in the dental care environment remains essential to
ensuring the public's safety and retaining its confidence. In the 15
years since CDC published its first guidelines for infection control in
dentistry, infection control practices have dramatically improved.
Nevertheless, the potential for disease transmission during visits to
the dentist continues to arouse intense public interest and media
scrutiny. To minimize this potential, CDC assesses the risks of
infectious disease transmission, updates guidelines to minimize those
risks, investigates disease outbreaks and environmental hazards in
dental settings, and identifies emerging problems. Infection control
activities address the "Healthy People 2010\" priority areas in
Occupational Safety and Health, Immunization and Infectious Diseases,
and HIV Infection.

1\. Develop surveillance system(s) and outcome measures for adverse
events related to exposure to pathogens and other hazardous agents
during dental treatment.

2\. Develop methods or models for evaluating the effectiveness and
cost-effectiveness of infection control interventions.

3\. Develop dental devices with passive safety features that meet or
exceed performance criteria identified by CDC
(www.cdc.gov/oralhealth/infectioncontrol/forms.htm).

4\. Develop devices, both accurate and passive, to measure biofilm or
bacterial contamination in dental waterlines.

5\. Develop educational/training materials and demonstrate their
effectiveness in on-the-job training of dental assistants in dental
office infection control and quality assurance.

6\. Develop training and educational materials for using the oral rapid
HIV screening test in dental facilities to identify cases of HIV
infection that may otherwise go undetected.

B. Oral Health

In collaboration with several partners, the Division develops national
plans and supports programs in specific areas of oral health including
appropriate use of fluorides and sealants to prevent dental caries
(tooth decay); activities that address the oral health needs of an aging
population; and implementation of strategies to reduce disparities in
oral health status. This includes expanding the capacity and ability of
state health departments to implement community water fluoridation and
school-based/-linked dental sealant programs. The following are topics
of interest in oral health.

1\. Develop accurate, non-invasive methods or devices to aid in
diagnosis, measurement, and recording of dental caries.

2\. Identify biomarkers or develop methods or devices to measure total
fluoride exposure.

3\. Develop oral hygiene products or devices for adults with motor
difficulties.

4\. Develop innovative fluoride delivery systems for home use among
persons at increased risk for dental caries (tooth decay).

5\. Develop innovative methods to defluoridate water with high natural
fluoride concentrations.

6\. Develop innovative sealant materials, supplies or equipment for use
by sealant programs in non-traditional dental settings.

For technical information, contact:

Jennifer L. Cleveland, D.D.S., M.P.H.

Dental Officer/Epidemiologist

Division of Oral Health

Mailstop F-10

Atlanta, GA 30341

\(770\) 488-6066, Fax: (770) 488-6080

Email: <JLCleveland@cdc.gov>

For administrative and business management information, contact:

Mr. Curtis Bryant, Small Business Specialist

Dept. of Health and Human Services

Office of Small and Disadvantaged Business Utilization, supporting CDC

Mail Stop E14

2920 Brandywine Road

Atlanta, Georgia 30341

\(770\) 488-2806, Fax: (770) 488-2828

Email: <ckb9@cdc.gov>

For grants specific information, contact:

Ms. Nealean Austin

Centers for Disease Control and Prevention

Procurement and Grants Office

Mail Stop E-09

2920 Brandywine Road

Atlanta, Georgia 30341

\(770\) 488-2722, Fax: (770) 488-2777

Email: naustin@cdc.gov

[]{#__RefHeading___Toc124237038 .anchor}Division of Reproductive Health

*[Mission]{.underline}*

The mission of the Division of Reproductive Health (DRH) is to promote
optimal reproductive and infant health and quality of life by
influencing public policy, health care practice, community practices,
and individual behaviors through scientific and programmatic expertise,
leadership, and support.

The Division accomplishes its mission by working with partners
throughout the nation and world to

-   Conduct epidemiologic, behavioral, demographic, and health services
    research.

-   Support national and state-based surveillance systems to monitor
    trends and investigate health issues.

-   Support scientific and programmatic development within states and
    other jurisdictions.

-   Provide technical assistance, consultation, and training worldwide.

-   Translate research findings into health care practice, public health
    policy, and health promotion strategies.

*[Goals]{.underline}*

-   **Outcomes** -- Improve and promote infant health and reproductive
    health, and well being of men and women globally.

-   **Leadership** -- Provide global leadership to optimize reproductive
    and infant health.

-   **Research** -- Define, conduct, and promote public health research
    in reproductive and infant health.

-   **Translation** -- Translate science and technology into strategies
    and interventions that promote reproductive and infant health.

-   **Infrastructure** -- Maintain a healthy, productive environment,
    which supports achievement of the mission.

-   **Capacity Building** -- Enhance the ability of others to identify
    and address reproductive and infant health issues.

*[Priorities]{.underline}*

-   Women's Reproductive Health

-   Unintended Pregnancy Prevention

-   Maternal Health

-   Infant Health

-   Global Reproductive Health

Programmatic point of contact:

Shaunette Crawford, Associate Director for Policy, Legislation

Division of Reproductive Health

National Center for Chronic Disease Prevention and Health Promotion

7760-488-6241, Fax: 770-488-6253

Email: <Scrawford@cdc.gov>

<http://www.cdc.gov/reproductivehealth/index.htm>

For administrative and business management information, contact:

Mr. Curtis Bryant, Small Business Specialist

Dept. of Health and Human Services

Office of Small and Disadvantaged Business Utilization, supporting CDC

Mail Stop E14

2920 Brandywine Road

Atlanta, Georgia 30341

\(770\) 488-2806, Fax: (770) 488-2828

Email: <ckb9@cdc.gov>

For grants specific information, contact:

Ms. Mildred Garner

Centers for Disease Control and Prevention

Procurement and Grants Office

Mail Stop E-09

2920 Brandywine Road

Atlanta, Georgia 30341

\(770\) 488-2722, Fax: (770) 488-2777

Email: <mgarner@cdc.gov>

[]{#__RefHeading___Toc124237039 .anchor}National Center for Injury
Prevention and Control (NCIPC)

The National Center for Injury Prevention and Control plans, directs,
and coordinates a national program to maintain and improve the health of
the American people by preventing premature death and disability and
reducing human suffering and medical costs caused by nonoccupational
injury, addressing both intentional injuries that result from violent
and abusive behavior and unintentional injuries. The national program
encompasses the prevention of nonoccupational injuries, and applied
research and evaluations in acute care and rehabilitation of injured
persons. The Center will address injury prevention and control through
an orderly sequence of activities beginning with research on causes,
circumstances, and risk factors; progressing through research on
interventions and their impact on defined populations. These activities
then lead to the broad, systematic applications of interventions that
are soundly based scientifically.

CDC is committed to achieving the health promotion and disease
prevention objectives of \"Healthy People 2010,\" a PHS-led national
activity for setting priority areas. CDC encourages applicants to submit
grant applications with relevance to the specific objectives of this
initiative. Potential applicants may obtain a copy of \"Healthy People
2010\"; (Full Report: Stock No. 017-001-00537-1): through the
Superintendent of Documents, Government Printing Office, Washington,
D.C. 20402-9325, (202) 512-1800.

More recently, the Centers for Disease Control has published its *CDC
Injury Research Agenda*, June 2002, Atlanta Georgia, which identifies 95
research themes in various areas of injury research, including
preventing injuries at home and in the community and in sports,
recreation and exercise, preventing transportation injuries, preventing
intimate partner violence, sexual violence, child maltreatment, youth
violence and suicidal behavior and acute care, disability and
rehabilitation. The full report is available at
<http://www.cdc.gov/ncipc>.

The focus of the research topics for SBIR should reflect the themes
represented in the research agenda designed to control injury morbidity,
mortality, disability, and costs. These projects may be categorized by
the three phases of injury prevention and control. Research topics of
interest include, but are not limited to:

A. ***[Prevention.]{.underline}*** There is interest in the development,
application, and evaluation of innovative interventions applicable to
intentional and unintentional injury. The focus should reflect target
populations at high risk for injury and injury consequences, including
minorities, children, the elderly, rural residents, and farm families.
SBIR projects that have relevance for reducing injury or increasing
dissemination and adoption of effective injury prevention interventions
are sought. The following are examples:

1\. Develop technology to improve technology transfer on effective
interventions to prevent unintentional injuries and violence.

2\. Develop a practical, valid tool to measure the adequacy of
supervisory practices to prevent childhood injuries, such as drownings
and falls.

3\. Develop technology-based methods to obtain exposure and injury
incidence data for injuries in sports and recreational activities.

4\. Develop new improved and practical alcohol breath testing devices
that can be used in multiple settings (by enforcement personnel, bar
patrons, and the public).

5\. Develop environmental and behaviorial devices that can assist in the
prevention of pedestrian injuries, including technology-based strategies
that provide feedback to drivers and walkers about impending hazards.

6\. Design, develop, and evaluate educational materials to train public
health personnel in injury prevention that could be adapted for
medicine, nursing and allied health.

7\. Develop and evaluate injury and violence prevention materials
uniquely targeted to and disseminated in medical care and managed care
settings, such as in-house kiosks, computer-based self-assessments, and
clinical preventive services based interventions or through the use of
distance-based learning technology. These materials can address topics
such as falls, helmets, supervision and prevention of youth violence or
intimate partner violence.

8\. Develop and test a passive alcohol sensor device to passively
measure the blood alcohol level of injured patients arriving at the
emergency department.

9\. Develop products to improve monitoring and control of exposure to
violent media.

10\. Develop innovative educational products to teach non violent
resolution of conflicts in partner or family situations.

11\. Develop and evaluate video/computer technology to improve staff
training and program fidelity monitoring of efficacious parent training
programs for the prevention of child maltreatment.

B. ***[Acute Care.]{.underline}***

1\. Develop developmentally appropriate devices, instruments, methods,
models, tests, and computer software related to the full spectrum of
acute care of the trauma patient, beginning with the establishment of
access to emergency care, response at the injury scene, transportation
of the critically injury, to management of postoperative complications
such as multiple organ failure syndrome.

2\. There is a need to improve diagnostic modalities in several areas,
particularly in those related to perfusion and oxygenation at the tissue
level. Further, among those patients whose bleeding has been controlled
and who will survive the acute phase of injury, the major causes of
death are irreversible cerebral damage or uncontrollable cerebral
swelling and multiple organ failure. There is an urgent need for
research into methods of reducing secondary cerebral injury and of
controlling brain swelling and preventing multiple organ failure.

3\. Design, develop and evaluate Emergency Department-based prevention
services for the identification and referral of persons at risk for
violence or alcohol-related injury.

C. ***[Rehabilitation.]{.underline}***

1\. Develop developmentally appropriate adaptive equipment, assistive
devices, and instructional materials directed toward preventing or
minimizing the secondary complications of individuals with traumatic
brain or spinal cord injuries including cognitive learning problems,
pressure ulcers, contractures, muscular atrophy, skeletal deformity and
other definable conditions.

2\. Design, develop and evaluate educational materials for persons with
traumatic brain or traumatic spinal cord injury, their families and/or
caregivers that are directed toward preventing or minimizing the
secondary complications associated with these injuries.

3\. Develop training materials to assist persons with disabilities and
their care givers to safely and efficiently evacuate various buildings,
(e.g., multi-storied structures) in emergencies.

4\. Develop products to improve monitoring and control of exposure to
violent media.

5\. Develop innovative educational products to teach non violent
resolution of conflicts in partner or family situations.

[]{#__RefHeading___Toc124237040 .anchor}Other Research Topic(s) Within
the Mission of the Center

For programmatic information, contact:

Ms. Darlene Harris

Centers for Disease Control and Prevention

National Center for Injury Prevention and Control

Office of the Associate Director for Science

Mailstop K-02

4770 Buford Highway, N.E.

Atlanta, Georgia 30341-3724

\(770\) 488-4512, Fax: (770) 488-4422

Email: <dph2@cdc.gov>

For administrative and business information, contact:

Mr. Curtis Bryant, Small Business Specialist

Dept. of Health and Human Services

Office of Small and Disadvantaged Business Utilization, supporting CDC

Mail Stop E14

2920 Brandywine Road

Atlanta, Georgia 30341

\(770\) 488-2806, Fax: (770) 488-2828

Email: <ckb9@cdc.gov>

For grants specific information, contact:

Ms. Edna Green

Centers for Disease Control and Prevention

Procurement and Grants Office

Mail Stop K70

2920 Brandywine Road

Atlanta, Georgia 30341

\(770\) 488-2743, Fax: (770) 488-2777

Email: <egreen@cdc.gov>

[]{#__RefHeading___Toc124237041 .anchor}National Institute for
Occupational Safety and Health (NIOSH)

The NIOSH plans, directs and coordinates the national program effort to
develop and establish recommended occupational safety and health
standards and to conduct research, training, and related activities to
assure safe and healthful working conditions for every working man and
woman. NIOSH has both a regular grant program and an SBIR grant program;
the purpose of both is to develop knowledge that can be used in
preventing occupational diseases and injuries. In the regular NIOSH
grant program, the following types of applied research projects are
supported: causal research to identify and investigate the relationships
between hazardous working conditions and associated occupational
diseases and injuries; methods research to develop more sensitive means
of evaluating hazards at work sites, as well as methods for measuring
early markers of adverse health effects and injuries; control research
to develop new protective equipment, engineering control technology, and
work practices to reduce the risks of occupational hazards; and
demonstrations to evaluate the technical feasibility or application of a
new or improved occupational safety and health procedure, method,
technique, or system.

Control Technology and Personal Protective Equipment

Engineering controls, administrative policies, and personal protective
equipment are needed to manage exposures to occupational hazards.
Engineering controls include substitution of a safe material for a
hazardous one, design changes to equipment, or modification of work
methods to eliminate or reduce hazards. Changes in work practices and
management policies and training programs are examples of administrative
controls. In some cases where it is not otherwise possible to maintain a
healthy work environment, personal protective equipment such as
respirators and protective clothing can be used to isolate workers from
the hazard. Research is needed to develop and evaluate control
strategies for specific hazards and to assure their practicality and
usability in workplaces.

A. Improve the effectiveness of existing or proposed engineering
controls (including retrofit solutions).

B. Develop control measures for new workplace hazards.

C. Develop products or approaches that reduce/eliminate the specific
hazardous parts of a job that contribute most to the actual exposure,
including personal hygiene where contamination of surfaces, clothing, or
skin may occur.

D. Develop personal protective equipment that will fit the
anthropometric diversity in today's workforce.

F. Develop alternatives to pesticide application and hazardous waste
remediation.

G. Develop micro sensing devices to notify workers before chemicals
break through protective clothing and identify failures in containment
systems for hazardous materials.

H. Develop new materials for clothing to protect against chemical and
physical hazards.

I. Develop information dissemination methods to help businesses learn
about and implement occupational safety and health programs.

J. Develop training materials to teach hazards and risks, demonstrate
solutions, measure changes in behavior and practices, and improve injury
and illness rates.

Exposure Assessment Methods

Exposure assessment is a multi-disciplinary field central to deciding
whether and how to use resources for reducing workplace exposures, and
to defining exposure-response relationships in epidemiologic studies.
Rapid, inexpensive measurement tools and improved data analysis methods
are needed for the collection of adequate exposure data and for
effective intervention. At least three major gaps in current methods
will drive development of exposure assessment methods in the next
decade: (1) the lack of sufficiently precise exposure assessments to
support accurate epidemiologic studies in the complex environments of
today\'s workplaces, (2) the lack of practical measurement techniques
that can be applied at reasonable cost in many workplaces where hazards
may exist, and (3) the lack of validated methods for measuring relevant
exposure and total dose data directly from biological samples obtained
by relatively noninvasive techniques.

A. Develop computer models to extrapolate information from historical
data of limited exposure measurements to apply to large study
populations, and to incorporate short-duration but high-intensity
exposures such as leaks or spills into the models.

B. Develop easy-to-use, direct-reading instruments and test kits to
measure exposures rapidly and inexpensively in a variety of workplaces
for routine monitoring, evaluating the success of control technologies,
and providing data for research studies.

C. Improve the measurement of low concentrations of chemicals and
biomarkers in biological specimens such as blood, urine, saliva and
sweat so that such concentrations can be linked to internal dose at the
target organs.

D. Design laboratory analytical methods for inexpensively measuring
numerous chemicals in a single sample.

E. Formulate exposure survey designs and methods for exposure data
analysis to obtain more meaningful data for health risk assessments.

F. Improve exposure assessment methods so that at-risk workers can be
identified.

Intervention Effectiveness Research

The goal of intervention research is to develop practical strategies and
techniques that effectively reduce or prevent workplace injuries and
illnesses. Workplace safety and health interventions include but are not
limited to developing and implementing specific engineering control
technologies, process and work organization changes, information
dissemination and health communication practices, worker/management
participatory safety and health programs, safety and health training,
selective use of personal protective equipment, and inspection and
enforcement of protective exposure limits. Intervention research
involves the testing and evaluation of interventions, programs, and
policies. Although many intervention strategies have been applied to
industrial settings, knowledge about what works best is limited.
Corporate safety and health programs, regulatory requirements and
voluntary consensus standards, workers\' compensation policies and
loss-control programs, engineering controls, and educational campaigns
are among the types of interventions that need to be developed,
implemented, and evaluated.

A. Develop techniques to evaluate the effectiveness of implemented
control technologies.

B. Develop materials and methods for increasing the acceptance of new
control technologies and develop approaches to eliminate or alter these
barriers, including economic feasibility.

C. Develop intervention efforts in the areas of greatest need.

Surveillance Research Methods

Surveillance systems describe where occupational hazards, injuries, or
illnesses are found, how frequently they are found, whether they are
increasing or decreasing, and whether prevention efforts have been
effective. The public health community relies on surveillance
information to set research and prevention priorities, but critical gaps
in current systems limit their usefulness. These systems need to be
updated and expanded, and new systems and methodologies need to be
developed.

A. Develop approaches for implementing comprehensive, integrated
national systems utilizing data sources and models of surveillance that
exist in the public and private sectors.

B. Formulate methods to assess nationally or locally the impact of
intervention efforts on worker safety and health.

C. As restructuring of health care delivery systems occurs throughout
the United States, develop linkages among the systems to identify,
track, and target occupational safety and health problems and provide
information for decisions to develop interventions or to improve related
medical care.

D. Investigate hazard surveillance systems as a means of identifying
risks and exposures at worksites and industries, including risks
associated with prototypes of new technologies, before injuries and
illnesses occur.

[]{#__RefHeading___Toc124237042 .anchor}Other Research Topic(s) Within
the Mission of the Institute

Because of the diverse nature of occupational safety and health issues,
many other research topics are supported by NIOSH in addition to the
NORA topics. In addition, NIOSH supports research to reduce occupational
injuries and illness in sector specific areas including construction,
agriculture, and mining. Visit the NIOSH homepage for more information
on NIOSH's research program areas
<http://www.cdc.gov/niosh/homepage.html>.

Construction

Each day, construction workers face trench cave-ins, falls, machinery
accidents, electrocutions, and motor vehicle incidents. NIOSH
researchers identify causes of and develop programs to prevent injuries
and fatalities in construction.

A. Commercialization of new designs or controls to reduce dust emissions
from tools such as jackhammers.

B. Development of improved tool designs to reduce various hazards such
as noise, vibration, or awkward postures.

C. Information tools to facilitate hazard recognition (e.g. for
scaffolds, cranes, excavations) on job sites.

Agriculture

Agriculture ranks among the most hazardous industries. Farmers are at
high risk for fatal and nonfatal injuries, work-related lung diseases,
noise-induced hearing loss, skin diseases, and certain cancers
associated with chemical use and prolonged sun exposure. Farming is one
of the few industries in which the families (who often share the work
and live on the premises) are also at risk for injuries, illness, and
death.

A. Develop and evaluate devices that improve ladder safety.

B. Design and test improved safety and health training modules for
Latino farmers.

C. Safe use of pesticides for limited English speaking and other
minority farmers.

D. Roll over protection devices and roll over warning systems for older
tractors.

Mining

The mining industry is one of the more challenging occupational sectors
having to deal with adverse natural conditions such as cramped work
space, poor visibility, handling of large volumes of bulky and heavy
materials, and in many cases, a variety of unknowns including the
physical characteristics of the materials being mined and the
surrounding materials with little knowledge of the conditions ahead of
mining and difficulties in predicting and measuring the environmental
conditions of the mine workings. These environmental conditions include
dust concentrations, gas concentrations, noise levels, diesel
particulate matter levels and noise levels. Advancements in technology
and knowledge which would address any of the above concerns would be
beneficial to improving worker health and safety in the mining industry.
The advancements could be achieved through the development of new and
innovation technologies, enhanced understanding of the conditions and
improved approaches and strategies for dealing with the issues.

A. Develop new approaches for measurement or identification of
conditions in the vicinity surrounding current underground mining
operations.

B. Develop technology that has application for measuring or predicting
the exposure of mine workers to any of the factors present in surface
and underground mines. The factors include noise levels, diesel
particulate matter and dust concentrations.

C. Determine the effectiveness of and/or develop improved approaches for
training used to protect the health and safety of mine works.

D. Determine a methodology for evaluating the safety culture of the
mining community and develop an improved model which enhances the
overall safety of surface and underground mining operations.

For technical information on research topics, contact:

Ms. Susan Board

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health

Mail Stop E74

1600 Clifton Road, N.E.

Atlanta, Georgia 30333

\(404\) 498-2530, Fax: (404) 498-2569

Email: <SBoard@cdc.gov>

For administrative and business management information, contact:

Mr. Curtis Bryant

Dept. of Health and Human Services

Office of Small and Disadvantaged Business Utilization, supporting CDC

Mail Stop E14

2920 Brandywine Road

Atlanta, Georgia 30341

\(770\) 488-2806, Fax: (770) 488-2828

Email: <ckb9@cdc.gov>

For grants specific information contact:

Mr. Larry Guess

Centers for Disease Control and Prevention

Procurement and Grants Office

Mail Stop P-05

Pitt 140 220

Pittsburgh, PA 15236

\(412\) 386-6826, Fax: (412) 386-6429

Email: <LGuess@cdc.gov>

[]{#__RefHeading___Toc124237043 .anchor}FOOD AND DRUG ADMINISTRATION
(FDA)

FDA will accept SBIR grant applications on the April 1, August 1, and
December 1, 2006 submission dates.

The mission of the Food and Drug Administration (FDA) is to protect the
public health of the Nation as it may be impaired by foods, drugs,
biological products, cosmetics, medical devices, ionizing and
non-ionizing radiation-emitting products and substances, poisons,
pesticides, and food additives. FDA\'s regulatory functions are geared
to insure that foods are safe, pure, and wholesome; drugs, medical
devices, and biological products are safe and effective; cosmetics are
harmless; all of the above are honestly and informatively packaged; and
that exposure to potentially injurious radiation is minimized.

For additional information about areas of interest to the FDA, please
visit our home page at [http://www.fda.gov](http://www.fda.gov/).

[]{#__RefHeading___Toc124237044 .anchor}Center for Biologics Evaluation
and Research (CBER)

CBER is responsible for ensuring the safety, efficacy, potency and
purity of biological and related products intended for use in the
treatment, prevention or cure of diseases in humans as well as the
safety of the nation\'s supply of blood and blood products. The primary
responsibility of CBER is to review the quality, safety and efficacy of
vaccines, blood products, certain diagnostic products and other
biological and biotechnology-derived human products.

CBER\'s activities include: evaluating the quality, safety and
effectiveness of biological products before marketing, and monitoring
the pre-clinical and clinical testing of new biological products;
licensing biological products and manufacturing establishments,
including plasmapheresis centers, blood banks, vaccine and biotechnology
manufacturers; AIDS program and policy activities, including research on
AIDS therapeutic products, diagnostic tests and vaccines; research to
establish product standards, develop improved testing methods and assess
the safety of biological products; compliance, lot release program and
post market surveillance; meeting PDUFA goals, new research programs,
and new regulatory initiatives (managed review process for all
products).

[]{#__RefHeading___Toc124237045 .anchor}Center for Drug Evaluation and
Research (CDER)

CDER develops FDA policy with regard to the safety, effectiveness, and
labeling of all drugs for human use; evaluates new drug applications and
investigational new drug applications; develops standards for the safety
and effectiveness of all over-the-counter drugs; monitors the quality of
marketed drugs through product testing (bioavailability/bioequivalence
testing), post marketing surveillance, and compliance programs; develops
guidelines on good manufacturing practices; conducts research and
develops scientific standards on composition, quality, safety, and
efficacy of human drugs.

Drug regulatory research as conducted in CDER is directed at the
discovery of new knowledge relevant to drug development, postmarketing
drug experience (patterns of drug use and safety), and drug regulation
to enhance FDA regulatory decisions. These drug regulatory decisions
impact on the development of regulations, guidelines and guidance for
the regulated industry and provide clarity and consistency in
application of CDER regulatory requirements. These drug regulatory
decisions also impact public health by ensuring that marketing drugs are
safe and efficacious and that their risk: benefit profile remains
acceptable during the market life of a drug. Specific areas of research
conducted by the Center include: Pharmacology/toxicology,
microbiology/virology, clinical pharmacology, pediatric issues in drug
therapy, postmarketing drug safety, evaluation of effectiveness of
regulatory actions, patterns of drug use, including off-label, signal
detection methodologies (e.g., datamining techniques), epidemiologic
studies of therapeutics using population-based data, regulatory
compliance, product quality, and active surveillance methods.

Research and development opportunities within the FDA that lend
themselves to performance by small businesses include, but are not
limited to, the following:

A. Develop a system for gathering real-time data on physician
prescribing behavior, understanding and compliance with drug product
labeling and frequency of off-label prescribing.

B. Develop and evaluate the effectiveness of new methods and tools for
managing the known risks of marketed drug products (e.g., communicating
newly identified risks to health care practioners and patients).

C. Develop methods for timely active surveillance of newly approved drug
products in large populations to identify both expected and unexpected
outcomes.

D. Develop methods for actively collecting information on all cases of
classically drug-associated events (e.g., acute liver failure, blood
dyscrasias, severe desquamating skin disorders) to augment the FDA's
current passive surveillance system.

E. Develop improved clinical markers and methods with potential for
bed-side application for detection of the early onset of adverse drug
events.

F. Develop surrogate potency methods for biotech drug products to
replace traditional animal testing.

G. Development of psychochemical and in-vitro biological tests to
evaluate pharmaceutical equivalence of complex drug substances and drug
products.

H. Research into approaches to handle informative missing patient data
in clinical trials, including innovations in study designs and
statistical methods of analysis.

I. Statistical and computational methods and strategies for the design,
analysis and interpretation of microarray, genomic and proteonomic data.

[]{#__RefHeading___Toc124237046 .anchor}Center for Food Safety and
Applied Nutrition (CFSAN)

The Center for Food Safety and Applied Nutrition conducts research and
develops standards on the composition, quality, nutrition, and safety of
food, food additives, colors, and cosmetics. The Center also evaluates
FDA's surveillance and compliance programs relating to foods, colors,
and cosmetics; reviews industry petitions and develops regulations for
food standards to permit the safe use of color additives and food
additives; collects and interprets data on nutrition, food additives,
and environmental factors affecting the total chemical result posed by
food additives; and maintains a nutritional data bank.

CFSAN regulates all foods **except** meat, poultry and processed egg
products. CFSAN seeks research designed to complement and accelerate
efforts for the detection, prevention, and control of contamination that
may be responsible for illness or injury conveyed by foods, colors, and
cosmetics.

The priorities of FDA's food defense research program are based on
determining the food/agent combinations of highest concern.
Mission-critical knowledge gaps are addressed through translational
research concerning the need to anticipate, prevent, detect, respond,
and recover from terrorists' assaults on the food supply. This requires
research activities in five areas: (1) knowledge of the behavior of
microbiological, chemical, radiological, and biologically-derived toxic
agents in priority vulnerable foods during the stages of production,
distribution, marketing, and preparation; (2) enhanced information on
the susceptibility of the population to microbiological, chemical,
radiological, and biologically-derived toxic agents via priority
vulnerable foods; (3) identification and/or development of new
techniques for "shielding" priority vulnerable foods through the
development of new prevention and/or security technologies; (4)
development of enhanced sampling and detection methods for priority
agents in vulnerable foods including field deployable and in-line
sensor-based screening, analytical, and investigational (forensic)
technologies; and (5) development of effective methods for ensuring that
critical food production and manufacturing infrastructure can be rapidly
and effectively decontaminated in event of a terrorist attack. In accord
with section 3402(d) of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, FDA's food defense research is
particularly focused on tests and sampling methodologies to detect
intentional adulteration and tests that are suitable for inspections of
food at ports of entry to the U.S. The mission-critical needs require
that the research not stop at the generation of new knowledge and
technologies, but also include the validation of those approaches under
realistic conditions that reflect the diversity of the food industry,
and the transfer of that technology to the appropriate sectors of the
food industry.

[]{#__RefHeading___Toc124237047 .anchor}Center for Devices and
Radiological Health (CDRH)

CDRH develops FDA policy and solves problems related to public health
and safety of medical devices and radiation-emitting electronic
products. It evaluates applications for premarket approval of medical
devices, approves products development protocols and exemption requests
for investigational devices. It classifies devices into regulatory
categories, develops safety and effectiveness standards and good
manufacturing practices regulations, operates postmarket surveillance
and compliance programs, and provides technical, non-financial
assistance to small manufacturers. The Center also conducts programs to
reduce human exposure to hazardous ionizing and nonionizing radiation,
through an electronic product radiation control program and other
programs designed to control and to limit radiation exposure. The Center
develops and conducts research and testing programs in the areas of
physical, life, and engineering sciences related to the human health
effects of radiation and medical device technologies, provides expertise
and analyses for health-risk assessments, and also develops new or
improved measurement methods, techniques, instruments and analytical
procedures for evaluating product performance and reliability. The
overall research program may be categorized into four areas, as follows:

1\. Characterization of the constituents or components of products.

2\. Measurement of product performance.

3\. Bioeffects that derive from human exposure to radiation or medical
devices.

4\. Radiation metrology in support of Agency regulation of
radiation-emitting products.

Research and development opportunities within the FDA that lend
themselves to performance by small businesses include, but are not
limited to, the following:

A. Develop an optical non-destructive method for rapid microtopographic
evaluation and measurement of wear of articulating surfaces of implant
prostheses.

B. Develop a system, including CDROM database of human chemical
physiological, electrical and mechanical service environment test
parameters, for use to design test protocols for implant device
performance and for accelerated reliability testing.

C. Develop a system, including database and radiation dosimetry badges,
for monitoring and registering radiation exposure (dose) of health care
providers during interventional radiologic procedures (e.g.,
angioplasty, percutaneous renal stone removal).

D. Develop a context-sensitive audio and video user assistance or
training system that can be temporarily attached or permanently
integrated with a moderately complex medical device such as an IV pump,
defibrillator, or ventilator. Its ability to address the use of these
devices in the home environment is advantageous.

[]{#__RefHeading___Toc124237048 .anchor}Center for Veterinary Medicine
(CVM)

CVM is a public health organization that enables the marketing of
effective drugs, food additives, feed ingredients, and animal devices
that are safe to animals, humans, and the environment. The Center, in
partnership with Federal and state agencies and other customers, ensures
animal health and the safety of food derived from animals. The Center
makes timely, quality decisions and takes regulatory actions to ensure
that these products provide for quality health care of animals, minimize
the transmission of zoonotic diseases, and increase the efficiency of
production of animal-derived food and fiber. Regulatory decisions are
supported by research, the monitoring of product safety, and efficacy,
and the continual improvement of processes.

[]{#__RefHeading___Toc124237049 .anchor}Office of Orphan Products
Development

The Office of Orphan Products Development was established to identify
and facilitate the development of orphan products. Orphan products are
drugs, biologics, medical devices and foods for medical purposes, which
are indicated for a rare disease or condition (i.e., one affecting fewer
than 200,000 people in the United States). These products may be useful
in a rare disease/disorder but lack commercial sponsorship because they
are not considered commercially attractive for marketing. A subcategory
of orphan products are those marketed products in which there is
evidence suggesting usefulness in a rare disease/disorder but which are
not labeled for that disease/disorder because substantial evidence of
safety and effectiveness for that use is lacking.

Research and development opportunities within the FDA that lend
themselves to performance by small businesses include, but are not
limited to, the following:

A. Development of pediatric formulations for already approved products
for the specific purpose of submitting data to the FDA to include
pediatric labeling to the current label of the approved product.

B. Development of products for the treatment of rare diseases or
disorders including but not limited to neurological, metabolic, genetic,
ophthalmologic, hematologic, and dermatological diseases or disorders
for the specific purpose of obtaining marketing licensure.

C. Development of products for use in diagnosis of rare diseases for
which the diagnostic tool would be used in fewer than 200,000 persons
annually in the United States.

D. Development of vaccines for the prevention of rare diseases to be
used in fewer than 200,000 persons annually in the United States.

[]{#__RefHeading___Toc124237050 .anchor}Other Research Topic(s) Within
the Mission of FDA

For additional information on research topics and administrative and
business information, contact:

Mr. Phillip Osborne

Director, Division of Contracts and Grants Management

Food and Drug Administration

5600 Fishers Lane, HFA 500

Rockville, MD 20857

\(301\) 827-2476, Fax: (301) 827-7106

Email: <phillip.osborne@fda.gov>

Ms. Tya Marks

Grnats Management Specialist

Division of Contracts and Grants Management

Food and Drug Administration

5600 Fishers Lane, RM2139, FHSL

Rockville, MD 20857

\(301\) 827-7179, Fax: (301) 827-7106

Email: <tya.marks@fda.gov>