U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PHS 2009-2

OMNIBUS SOLICITATION OF THE\
NATIONAL INSTITUTES OF HEALTH,\
CENTERS FOR DISEASE CONTROL AND PREVENTION,\
FOOD AND DRUG ADMINISTRATION, AND\
ADMINISTRATION FOR CHILDREN AND FAMILIES FOR

SMALL BUSINESS INNOVATION\
RESEARCH (SBIR)

AND

SMALL BUSINESS TECHNOLOGY TRANSFER (STTR)

GRANT APPLICATIONS

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

Table of Contents

NIH, CDC, fda, and acF Program Descriptions and Research Topics

[**National Institutes of Health (NIH)
1**](#__RefHeading___Toc219687025)

[Trans-NIH Research Programs 2](#__RefHeading___Toc219687026)

[Phase II Competing Renewal Awards 2](#__RefHeading___Toc219687027)

[Development of Synthetic and Natural Biomaterial Reference Materials
2](#__RefHeading___Toc219687028)

[Research Supplements to Promote Diversity in Health-Related Research
3](#__RefHeading___Toc219687029)

[Technical Assistance Programs 4](#__RefHeading___Toc219687030)

[Niche Assessment Program 4](#__RefHeading___Toc219687031)

[Commercialization Assistance Program (CAP)
4](#__RefHeading___Toc219687032)

[Manufacturing Assistance Program 5](#__RefHeading___Toc219687033)

[NIH, CDC, FDA, and ACF Awarding Component Contact Information
6](#__RefHeading___Toc219687034)

[National Institute on Aging (NIA) 9](#__RefHeading___Toc219687035)

[Division of Behavioral and Social Research
9](#__RefHeading___Toc219687036)

[Division of Aging Biology 12](#__RefHeading___Toc219687037)

[Division of Neuroscience 14](#__RefHeading___Toc219687038)

[Division of Geriatrics and Clinical Gerontology
15](#__RefHeading___Toc219687039)

[Phase II Competing Renewal Awards 18](#__RefHeading___Toc219687040)

[Other Research Topic(s) Within the Mission of the Institute
18](#__RefHeading___Toc219687041)

[National Institute on Alcohol Abuse and Alcoholism (NIAAA)
19](#__RefHeading___Toc219687042)

[Phase II Competing Renewal Awards 19](#__RefHeading___Toc219687043)

[Pharmaceutical Development for Alcoholism Treatment
20](#__RefHeading___Toc219687044)

[Diagnostic Assessment of Alcohol Use Disorders and Comorbidity
21](#__RefHeading___Toc219687045)

[Treatment of Alcoholism 22](#__RefHeading___Toc219687046)

[Alcohol Biosensors and Data Analysis Systems
22](#__RefHeading___Toc219687047)

[Promoting Adherence to Medical, Pharmacologic, and Behavioral
Treatments 22](#__RefHeading___Toc219687048)

[Prevention 23](#__RefHeading___Toc219687049)

[Health Services Research on Alcohol-Related Problems
24](#__RefHeading___Toc219687050)

[Fetal Alcohol Syndrome (FAS) and Alcohol-Related Birth Defects
25](#__RefHeading___Toc219687051)

[Alcohol Use and HIV, HBV, or HCV Infection
25](#__RefHeading___Toc219687052)

[Science Education 26](#__RefHeading___Toc219687053)

[Research Tools 27](#__RefHeading___Toc219687054)

[Development and Clinical Testing of Biochemical Markers
27](#__RefHeading___Toc219687055)

[Other Research Topic(s) Within the Mission of the Institute
29](#__RefHeading___Toc219687056)

[National Institute of Allergy and Infectious Diseases (NIAID)
29](#__RefHeading___Toc219687057)

[Phase II Competing Renewal Awards 29](#__RefHeading___Toc219687058)

[Division of AIDS 30](#__RefHeading___Toc219687059)

[Division of Allergy, Immunology, and Transplantation
33](#__RefHeading___Toc219687060)

[Division of Microbiology and Infectious Diseases
34](#__RefHeading___Toc219687061)

[Other Research Topic(s) Within the Mission of the Institute
37](#__RefHeading___Toc219687062)

[National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS) 37](#__RefHeading___Toc219687063)

[Arthritis and Musculoskeletal and Skin Diseases
37](#__RefHeading___Toc219687064)

[National Institute of Biomedical Imaging and Bioengineering (NIBIB)
38](#__RefHeading___Toc219687065)

[Other Research Topic(s) Within the Mission of the Institute
41](#__RefHeading___Toc219687066)

[National Cancer Institute (NCI) 42](#__RefHeading___Toc219687067)

[Center to Reduce Cancer Health Disparities
42](#__RefHeading___Toc219687068)

[Division of Cancer Biology 43](#__RefHeading___Toc219687069)

[Division of Cancer Control and Population Sciences
49](#__RefHeading___Toc219687070)

[Division of Cancer Treatment and Diagnosis
51](#__RefHeading___Toc219687071)

[Division of Cancer Prevention 60](#__RefHeading___Toc219687072)

[Other Research Topic(s) Within the Mission of the Institute
63](#__RefHeading___Toc219687073)

[*eunice kennedy shriver* National Institute of Child Health and Human
Development (NICHD) 65](#__RefHeading___Toc219687074)

[Phase II Competing Renewal Awards 65](#__RefHeading___Toc219687075)

[Population Research 66](#__RefHeading___Toc219687076)

[Research for Mothers and Children 68](#__RefHeading___Toc219687077)

[Developmental Biology & Perinatal Medicine Research
70](#__RefHeading___Toc219687078)

[Medical Rehabilitation Research 71](#__RefHeading___Toc219687079)

[Other Research Topic(s) Within the Mission of the Institute
72](#__RefHeading___Toc219687080)

[National Institute on Drug Abuse (NIDA)
72](#__RefHeading___Toc219687081)

[Phase II Competing Renewal Awards 72](#__RefHeading___Toc219687082)

[Division of Basic Neuroscience and Behavioral Research (DBNBR)
73](#__RefHeading___Toc219687083)

[Division of Epidemiology, Services and Prevention Research (DESPR)
79](#__RefHeading___Toc219687084)

[Center for the Clinical Trials Network
85](#__RefHeading___Toc219687085)

[Division of Pharmacotherapies & Medical Consequences of Drug Abuse
88](#__RefHeading___Toc219687086)

[Division of Clinical Neuroscience and Behavioral Research (DCNBR)
92](#__RefHeading___Toc219687087)

[Office of Science Policy and Communications (OSPC)
103](#__RefHeading___Toc219687088)

[International Program 104](#__RefHeading___Toc219687089)

[Other Research Topic(s) Within the Mission of the Institute
104](#__RefHeading___Toc219687090)

[National Institute on Deafness and Other Communication Disorders
(NIDCD) 105](#__RefHeading___Toc219687091)

[Phase II Competing Renewal Awards 105](#__RefHeading___Toc219687092)

[Hearing Program 106](#__RefHeading___Toc219687093)

[Balance/Vestibular Program 106](#__RefHeading___Toc219687094)

[Voice, Speech, and Language Programs 107](#__RefHeading___Toc219687095)

[Taste and Smell Program 107](#__RefHeading___Toc219687096)

[Other Research Topic(s) Within the Mission of the Institute
108](#__RefHeading___Toc219687097)

[National Institute of Dental and Craniofacial Research (NIDCR)
108](#__RefHeading___Toc219687098)

[Developmental Biology and Mammalian Genetics
108](#__RefHeading___Toc219687099)

[Infectious Diseases and Immunity 108](#__RefHeading___Toc219687100)

[Epithelial Cell Regulation and Transformation
109](#__RefHeading___Toc219687101)

[Mineralized Tissue and Salivary Gland Physiology, Pharmacogenetics and
Injury 110](#__RefHeading___Toc219687102)

[Molecular and Cellular Neuroscience 110](#__RefHeading___Toc219687103)

[Biotechnology and Biomaterials 111](#__RefHeading___Toc219687104)

[Clinical and Behavioral Research 112](#__RefHeading___Toc219687105)

[Other Research Topic(s) Within the Mission of the Institute
112](#__RefHeading___Toc219687106)

[National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) 113](#__RefHeading___Toc219687107)

[Phase II Competing Renewal Awards 113](#__RefHeading___Toc219687108)

[Diabetes, Endocrinology and Metabolic Diseases
114](#__RefHeading___Toc219687109)

[Digestive Diseases and Nutrition 116](#__RefHeading___Toc219687110)

[Kidney, Urologic and Hematologic Diseases
119](#__RefHeading___Toc219687111)

[Other Research Topic(s) Within the Mission of the Institute
122](#__RefHeading___Toc219687112)

[National Institute of Environmental Health Sciences (NIEHS)
123](#__RefHeading___Toc219687113)

[Exposure Biology Program 123](#__RefHeading___Toc219687114)

[Hazardous Waste Assessment, Evaluation and Remediation Program
125](#__RefHeading___Toc219687115)

[Predictive Test Systems for Safety Evaluation Program
125](#__RefHeading___Toc219687116)

[Educational and Training Resources Program
126](#__RefHeading___Toc219687117)

[Intervention Program 127](#__RefHeading___Toc219687118)

[Other Topics Within the Mission of the Institute
127](#__RefHeading___Toc219687119)

[National Eye Institute (NEI) 127](#__RefHeading___Toc219687120)

[Phase II Competing Renewal Awards 127](#__RefHeading___Toc219687121)

[General Research Topics 128](#__RefHeading___Toc219687122)

[Retinal Diseases Program 128](#__RefHeading___Toc219687123)

[Corneal Diseases Program 129](#__RefHeading___Toc219687124)

[Lens and Cataract Program 129](#__RefHeading___Toc219687125)

[Glaucoma and Optic Neuropathies Program
129](#__RefHeading___Toc219687126)

[Strabismus, Amblyopia, and Visual Processing Program
129](#__RefHeading___Toc219687127)

[Visual Impairment and Blindness Program
129](#__RefHeading___Toc219687128)

[Additional Information 129](#__RefHeading___Toc219687129)

[National Institute of General Medical Sciences (NIGMS)
130](#__RefHeading___Toc219687130)

[Phase II Competing Renewal Awards 130](#__RefHeading___Toc219687131)

[Division of Cell Biology and Biophysics
131](#__RefHeading___Toc219687132)

[Division of Genetics and Developmental Biology
132](#__RefHeading___Toc219687133)

[Division of Pharmacology, Physiology, and Biological Chemistry
133](#__RefHeading___Toc219687134)

[Center for Bioinformatics and Computational Biology
136](#__RefHeading___Toc219687135)

[Other Research Topic(s) Within the Mission of the Institute
136](#__RefHeading___Toc219687136)

[National Heart, Lung, and Blood Institute (NHLBI)
136](#__RefHeading___Toc219687137)

[Phase II Competing Renewal Awards 137](#__RefHeading___Toc219687138)

[Cardiovascular Diseases 140](#__RefHeading___Toc219687139)

[Lung Diseases 144](#__RefHeading___Toc219687140)

[Blood Diseases and Resources 147](#__RefHeading___Toc219687141)

[Prevention and Population Sciences 150](#__RefHeading___Toc219687142)

[Other Research Topic(s) Within the Mission of the Institute
153](#__RefHeading___Toc219687143)

[National Human Genome Research Institute (NHGRI)
154](#__RefHeading___Toc219687144)

[Technology and Methods Development 155](#__RefHeading___Toc219687145)

[Bioinformatics 155](#__RefHeading___Toc219687146)

[Computational Biology 155](#__RefHeading___Toc219687147)

[Population Genomics 156](#__RefHeading___Toc219687148)

[Ethical, Legal and Social Implications
156](#__RefHeading___Toc219687149)

[Other Research Topic(s) Within the Mission of the Institute
156](#__RefHeading___Toc219687150)

[National Institute of Mental Health (NIMH)
157](#__RefHeading___Toc219687151)

[NIMH-Supported Program Announcements:
157](#__RefHeading___Toc219687152)

[Phase II Competing Renewal Awards 158](#__RefHeading___Toc219687153)

[Division of Neuroscience and Basic Behavioral Science
160](#__RefHeading___Toc219687154)

[The Division of Developmental Translational Research
169](#__RefHeading___Toc219687155)

[Division of Adult Translational Research and Treatment Development
(DATR) 172](#__RefHeading___Toc219687156)

[Division of AIDS and Health and Behavior Research (DAHBR)
176](#__RefHeading___Toc219687157)

[Division of Services and Intervention Research
182](#__RefHeading___Toc219687158)

[National Institute of Neurological Disorders and Stroke (NINDS)
188](#__RefHeading___Toc219687159)

[Phase II Competing Renewal Awards 188](#__RefHeading___Toc219687160)

[Translational Research 189](#__RefHeading___Toc219687161)

[Countermeasures Against Chemical Threats
190](#__RefHeading___Toc219687162)

[Clinical Trials 190](#__RefHeading___Toc219687163)

[Specific Research Topics of Interest to NINDS and affiliated
programmatic areas 191](#__RefHeading___Toc219687164)

[National Institute of Nursing Research (NINR)
202](#__RefHeading___Toc219687165)

[Research and Development of Technologies for Health Promotion and\
Alleviation, Adaptation to, or Management of Symptoms
202](#__RefHeading___Toc219687166)

[Research and Development of Technologies to Enhance Self Care and\
Clinical Care 203](#__RefHeading___Toc219687167)

[Other Research Topic(s) Within the Mission of the Institute
203](#__RefHeading___Toc219687168)

[National Center for Research Resources (NCRR)
204](#__RefHeading___Toc219687169)

[Phase II Competing Renewal Awards 204](#__RefHeading___Toc219687170)

[Research and Development in Instrumentation and Specialized
Technologies for Biomedical Research 205](#__RefHeading___Toc219687171)

[Research and Development in Comparative Medicine
207](#__RefHeading___Toc219687172)

[Clinical Technology Applications 208](#__RefHeading___Toc219687173)

[Development of Discovery-Oriented Software and Tools for Science and
Health Education 209](#__RefHeading___Toc219687174)

[Other Research Topic(s) Within the Mission of the Center
210](#__RefHeading___Toc219687175)

[National Center for Complementary and Alternative Medicine (NCCAM)
211](#__RefHeading___Toc219687176)

[Technology Development and Research 211](#__RefHeading___Toc219687177)

[Topics That Are of Less Interest to NCCAM
212](#__RefHeading___Toc219687178)

[Other Research Topic(s) Within the Mission of the Center
212](#__RefHeading___Toc219687179)

[National Center on Minority Health and Health Disparities (NCMHD)
212](#__RefHeading___Toc219687180)

[Natural History of Disparities in Health Outcomes
213](#__RefHeading___Toc219687181)

[Health Promotion and Prevention Research in the Health Disparities
Communities 213](#__RefHeading___Toc219687182)

[Innovations in Health Disparities Research
214](#__RefHeading___Toc219687183)

[Broad Area of Research that we Support
214](#__RefHeading___Toc219687184)

[National Library of Medicine (NLM) 215](#__RefHeading___Toc219687185)

[Other Research Topic(s) Within the Mission of the Center
215](#__RefHeading___Toc219687186)

[CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
215](#__RefHeading___Toc219687187)

[National Center for Injury Prevention and Control (NCIPC)
216](#__RefHeading___Toc219687188)

[Other Research Topic(s) Within the Mission of the Center
219](#__RefHeading___Toc219687189)

[National Center for Health Statistics (NCHS)
220](#__RefHeading___Toc219687190)

[National Center for Public Health Informatics (NCPHI)
221](#__RefHeading___Toc219687191)

[National Center on Birth Defects and Developmental Disabilities
(NCBDDD) 222](#__RefHeading___Toc219687192)

[National Center for Chronic Disease Prevention and Health Promotion
(NCCDPHP) 223](#__RefHeading___Toc219687193)

[Division of Adult and Community Health
225](#__RefHeading___Toc219687194)

[Division of Cancer Prevention and Control
225](#__RefHeading___Toc219687195)

[Office on Smoking and Health 226](#__RefHeading___Toc219687196)

[Division of Oral Health 227](#__RefHeading___Toc219687197)

[Division of Reproductive Health 228](#__RefHeading___Toc219687198)

[Division for Heart Disease and Stroke Prevention
229](#__RefHeading___Toc219687199)

[National Institute for Occupational Safety and Health (NIOSH)
230](#__RefHeading___Toc219687200)

[Other Research Topic(s) Within the Mission of the Institute
236](#__RefHeading___Toc219687201)

[National Center for Environmental Health (NCEH)
236](#__RefHeading___Toc219687202)

[The Coordinating Center for Infectious Diseases
239](#__RefHeading___Toc219687203)

[National Center for HIV/AIDs, Viral Hepatitis, STD, and TB Prevention
(NCHHSTP) 239](#__RefHeading___Toc219687204)

[Division of HIV/AIDS Prevention 239](#__RefHeading___Toc219687205)

[Division of STD Prevention 241](#__RefHeading___Toc219687206)

[Coordinating Office for Terrorism Preparedness and Emergency Response
(COTPER) 243](#__RefHeading___Toc219687207)

[FOOD AND DRUG ADMINISTRATION (FDA) 247](#__RefHeading___Toc219687208)

[Center for Biologics Evaluation and Research (CBER)
247](#__RefHeading___Toc219687209)

[Center for Drug Evaluation and Research (CDER)
247](#__RefHeading___Toc219687210)

[Center for Food Safety and Applied Nutrition (CFSAN)
248](#__RefHeading___Toc219687211)

[Center for Devices and Radiological Health (CDRH)
249](#__RefHeading___Toc219687212)

[Center for Veterinary Medicine (CVM) 250](#__RefHeading___Toc219687213)

[Office of Orphan Products Development
250](#__RefHeading___Toc219687214)

[Other Research Topic(s) Within the Mission of FDA
251](#__RefHeading___Toc219687215)

[Administration for Children and Families
252](#__RefHeading___Toc219687216)

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

Funding Opportunity Announcements

REMINDER: ALL APPLICATIONS MUST BE SUBMITTED IN RESPONSE TO A FUNDING
OPPORTUNITY ANNOUNCEMENT THROUGH GRANTS.GOV

Small Business Innovation Research Program Parent Announcement (SBIR
\[R43/R44\])
[[http://grants.nih.gov/grants/guide/pa-files/PA-09-080.html]{.smallcaps}](http://grants.nih.gov/grants/guide/pa-files/PA-09-080.html)

Small Business Technology Transfer Program Parent Announcement (STTR
\[R41/R42\])
[[http://grants.nih.gov/grants/guide/pa-files/PA-09-081.html]{.smallcaps}](http://grants.nih.gov/grants/guide/pa-files/PA-09-081.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

SF424 (R&R) Application INSTRUCTIONS 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
(<https://s-edison.info.nih.gov/iEdison/timeline.jsp>)

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

# 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 (i.e., Institutes and Centers (ICs)) identified in this
solicitation.

Applicants are strongly encouraged to subscribe to the NIH Guide for
Grants and Contracts LISTSERV
(<http://grants.nih.gov/grants/guide/listserv.htm>) or query program
administrators periodically via email to learn of new or emerging
scientific interests of the NIH, CDC, FDA, and ACF awarding components.

You may also subscribe to the SBIR-STTR LISTSERV list to get timely
information about the NIH SBIR/STTR Programs
(<http://grants.nih.gov/grants/funding/listserv.htm>).

Additional information on each of the awarding components (ICs) 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___Toc219687025 .anchor}National Institutes of Health
(NIH)

NIH is the steward of medical and behavioral research for the Nation.
Its mission is science in pursuit of fundamental knowledge about the
nature and behavior of living systems and the application of that
knowledge to extend healthy life and reduce the burdens of illness and
disability.

The goals of the agency are as follows:

1\. foster [fundamental creative
discoveries](http://www.nih.gov/about/researchhighlights/index.htm),
innovative research strategies, and their applications as a basis to
advance significantly the Nation\'s capacity to protect and improve
health;

2\. develop, maintain, and renew scientific human and physical resources
that will assure the Nation\'s capability to prevent disease;

3\. expand the knowledge base in medical and associated sciences in
order to enhance the Nation\'s economic well-being and ensure a
continued high return on the public investment in research; and

4\. exemplify and promote the highest level of scientific integrity,
public accountability, and social responsibility in the conduct of
science.

In realizing these goals, the NIH provides leadership and direction to
programs designed to improve the health of the Nation by conducting and
supporting research:

-   in the causes, diagnosis, prevention, and cure of human diseases;

-   in the processes of human growth and development;

-   in the biological effects of environmental contaminants;

-   in the understanding of mental, addictive and physical disorders;
    and

-   in directing programs for the collection, dissemination, and
    exchange of information in medicine and health, including the
    development and support of medical libraries and the training of
    medical librarians and other health information specialists.

In addition, the NIH sponsors training of research personnel; career
development of new and established scientists; construction and
renovation of research facilities and provision of other research
resources.

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.

Funding levels for projects are determined through the combined
interaction among peer review, grants management, program, budget, and
other Institute and/or Centers (IC) staff. These levels are based on
allowable costs that are consistent with the principles of sound cost
management and in consideration of IC priorities, constraints on the
growth of average grant costs, and the availability of funds.

[]{#__RefHeading___Toc219687026 .anchor}Trans-NIH Research Programs

[]{#__RefHeading___Toc219687027 .anchor}Phase II Competing Renewal
Awards

Some NIH Institutes/Centers (ICs) offer Phase II SBIR/STTR awardees the
opportunity to apply for Phase II Competing Renewal awards. These are
available for those projects that require extraordinary time and effort
in the R&D phase and may or may not require FDA approval for the
development of such projects, including drugs, devices, vaccines,
therapeutics, and medical implants related to the mission of the IC.
Some ICs have announced this opportunity through the NIH Guide for
Grants and Contracts (see link 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. Prospective applicants are strongly encouraged
to contact NIH staff prior to submission. 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
Funding Opportunity
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: **NCRR** (SBIR only), **NIA, NIAAA, NIAID, NICHD** (SBIR
only)**, NIDA, NIDCD, NIDDK, NIGMS** (SBIR only), **NEI** (SBIR only and
only Competing Renewals of NEI-supported Phase II awards**), NHLBI**
(SBIR only and only Competing Renewals of NHLBI-supported Phase II
awards), **NIMH** (SBIR only), and **NINDS.**

[]{#__RefHeading___Toc219687028 .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.

Program Director

Heart Failure & Arrhythmias Branch

Division of Cardiovascular Diseases

National Heart, Lung, and Blood Institute, NIH

6701 Rockledge Drive, Room 8186, MSC 7956

Bethesda, MD 20892-7956

(For express mail, zip code 20817)

301-435-0504; Fax: 301-480-7404

Email: <adhikarb@mail.nih.gov>

[]{#__RefHeading___Toc219687029 .anchor}Research Supplements to Promote
Diversity in Health-Related Research

(See Funding Opportunity Announcement at
<http://grants.nih.gov/grants/guide/pa-files/PA-08-190.html>.)

The NIH notifies Principal Investigators holding specific types of NIH
research grants (including SBIR and STTR awards) that funds are
available for administrative supplements to improve the diversity of the
research workforce by supporting and recruiting students,
postdoctorates, and eligible investigators from groups that have been
shown to be underrepresented. Although the administrative supplements
supported under this program provide funding for less than one percent
of all individuals involved in NIH supported research, the NIH has found
these awards to be an effective means of encouraging institutions to
recruit from currently underrepresented groups. Administrative
supplements must support work within the scope of the original project.

All NIH awarding components and the National Institute for Occupational
Safety and Health at the CDC participate in this program. Candidates
eligible for support under this supplement program include individuals
at various career levels who come from groups that have been shown to be
underrepresented in science. Such candidates include individuals from
underrepresented racial and ethnic groups, individuals with
disabilities, and individuals from disadvantaged backgrounds. Detailed
eligibility criteria are described in the full announcement.

The NIH recognizes a unique and compelling need to promote diversity in
the biomedical, behavioral, clinical and social sciences research
workforce. The NIH expects efforts to diversify the workforce to lead to
the recruitment of the most talented researchers from all groups; to
improve the quality of the educational and training environment; to
balance and broaden the perspective in setting research priorities; to
improve the ability to recruit subjects from diverse backgrounds into
clinical research protocols; and to improve the Nation\'s capacity to
address and eliminate health disparities.

A currently funded Program Director/Principal Investigator may submit
one application on one topic. An application for a supplement may be
submitted at any time. In making requests, the grantee institution, on
behalf of the Principal Investigator of the parent grant and in
cooperation with the candidate **must submit the application for
supplemental funds directly to the awarding component that supports the
parent grant. The application must not be submitted through grants.gov
or to the NIH Center for Scientific Review.**

Requests for administrative supplements can be submitted to the NIH
Program Official listed in the contacts section of the FOA
[PA-08-190](http://grants.nih.gov/grants/guide/pa-files/PA-08-190.html)
at any time. Administrative supplements normally end with the
competitive cycle of the parent grant

[]{#__RefHeading___Toc219687030 .anchor}Technical Assistance Programs

**Available to NIH SBIR Awardees\
(Note that STTR Awardees are not eligible for these programs)**

One of the goals of the Small Business Innovation Research (SBIR)
program is to "increase private sector commercialization of innovations
developed through Federal SBIR R&D." To help NIH SBIR awardees move
their products into the marketplace, NIH has developed several
assistance programs that provide technical and/or commercialization
assistance specific to the individual needs of NIH SBIR awardees.

Additional information about these programs is available at
<http://grants.nih.gov/grants/funding/tap.htm>. Questions may be
addressed to the NIH SBIR Office at <sbir@od.nih.gov> or 301-435-2713.

[]{#__RefHeading___Toc219687031 .anchor}Niche Assessment Program

**(For NIH SBIR Phase I awardees)**

The Niche Assessment program focuses on obtaining the necessary
information for strategizing and making deals. Often, a research
scientist does not have the entrepreneurial skills to assess whether
there are other applications or niches for their SBIR-developed
technology. As a result, they may underestimate its true market value.
This program assesses the market opportunities, needs and concerns of
end-users and helps to discover new markets for possible entry. With the
assistance of the participant, a contractor will help identify niches
and potential partners. The contractor performs the due diligence and
provides an in-depth report that assesses such items as the potential
end-users needs, the competing technologies and products, the
competitive advantage, the market size and share that the participant
might expect, etc. Targets (end users) are contacted to ensure they are
viable leads and their contact information is included in the report for
possible follow-up. Participants may find this report helpful in
preparing the requisite Commercialization Plan for a Phase II
application. For detailed information about the Niche Assessment
Program, see <http://grants.nih.gov/grants/funding/nap.htm>.

Participation in this program is limited to NIH SBIR Phase I awardees
(grants and contracts) and participants need only commit a few hours to
inform and make the contractor fully conversant on their technology and
the niche they would like to have investigated. There is no cost to
participate in this program.

[]{#__RefHeading___Toc219687032 .anchor}Commercialization Assistance
Program (CAP)

**(For NIH SBIR Phase II awardees)**

The Commercialization Assistance Program (CAP) assists small companies
with getting their SBIR-developed technologies more rapidly into the
marketplace. It provides assistance with developing and implementing an
appropriate business strategy aimed at commercializing the products or
services that have resulted from NIH-supported SBIR awards.

CAP includes two distinctive tracks that offer customized assistance to
meet the specific needs of both early stage and seasoned companies: (1)
Commercialization Training Track (CTT), and (2) Accelerator
Commercialization Track (ACT), respectively. The CTT focuses on training
and mentoring by key industry and investment professionals and the
development of a clear and focused strategy toward commercialization.
ACT is geared toward the participant achieving clearly identified, very
specific objectives, using domain experts with current market
experience.

Participation in CAP is limited to NIH SBIR Phase II awardees (grants
and contracts) from the previous five years. Applications to participate
are typically accepted in early summer. Participation is free; however,
participants are responsible for travel and lodging expenses associated
with attending workshops and partnering investment events. Detailed
information is available at
<http://grants.nih.gov/grants/funding/cap.htm>.

[]{#__RefHeading___Toc219687033 .anchor}Manufacturing Assistance Program

**(For NIH SBIR Phase II awardees)**

The goal of the Manufacturing Assistance Program is to provide
individual technical assistance in manufacturing to SBIR Phase II
awardees as they prepare to commercialize their SBIR-developed products.
Through an effort with the National Institute of Standards and
Technology's (NIST) Manufacturing Extension Partnership (MEP) program
and their national network of non-profit centers, technical support is
provided to companies as they move to a developmental stage that
requires decisions in manufacturing transition strategies. This includes
but is not limited to: method of scale up, cost estimation, quality
control, prototyping, design for manufacturability, facility design,
process development/ improvement, vendor identification and selection,
plant layout and other similar issues. Upon completion, it is
anticipated that participating companies will be able to make better
manufacturing and operational decisions converting their research into
products by: (1) decreasing development costs and cycle time to market;
and (2) minimizing anticipated operational expenses and increasing
product quality.

Participation in this program is limited to NIH SBIR Phase II awardees
(grants and contracts) and participants must be willing to commit
approximately 100 person hours over a 2-3 month period. There is no cost
to participate in this program. Detailed information is available at
<http://grants.nih.gov/grants/funding/map_description.htm>.

[]{#__RefHeading___Toc219687034 .anchor}NIH, CDC, FDA, and ACF Awarding
Component Contact Information

+-----------------------+----------------------+----------------------+
| awarding component    | program contact      | grants mgmt. contact |
+=======================+======================+======================+
| National Institute on | Dr. Michael-David    | Ms. Linda Whipp\     |
| Aging                 | A.R.R. Kerns\        | Phone: 301-496-1472\ |
|                       | Phone: 301-496-9322\ | Fax: 301-402-3672\   |
| [http:/               | Fax: 301-402-2945\   | Email:               |
| /www.nia.nih.gov](htt | Email:               | <lw17m@nih.gov>      |
| p://www.nia.nih.gov/) | <mk417e@nih.gov>     |                      |
+-----------------------+----------------------+----------------------+
| National Institute on | Dr. Q. Max Guo\      | Ms. Judy Fox\        |
| Alcohol Abuse and     | Phone: 301-443-0639\ | Phone: 301-443-4704\ |
| Alcoholism            | Fax: 301-594-0673\   | Fax: 301-443-3891\   |
|                       | Email:               | Email:               |
| [http://www           | <QG7S@nih.gov>       | <js182a@nih.gov>     |
| .niaaa.nih.gov](http: |                      |                      |
| //www.niaaa.nih.gov/) |                      |                      |
+-----------------------+----------------------+----------------------+
| National Institute of | Dr. Gregory Milman\  | Mr. Michael Wright\  |
| Allergy and           | Phone: 301-496-8666\ | Phone: 301-451-2688\ |
| Infectious Diseases   | Fax: 301-402-0369\   | Fax: 301-493-0597\   |
|                       | Email:               | Email:               |
| [http://www           | <gm16s@nih.gov>      | <mw406g@nih.gov>     |
| .niaid.nih.gov](http: |                      |                      |
| //www.niaid.nih.gov/) |                      |                      |
+-----------------------+----------------------+----------------------+
| National Institute of | Mr. Elijah Weisberg\ | Ms. Sheila Simmons\  |
| Arthritis and         | Phone: 301-435-1002\ | Phone: 301-594-9812\ |
| Musculoskeletal and   | Fax: 301-480-4543\   | Fax: 301-480-5450\   |
| Skin Diseases         | Email:               | Email:               |
|                       | <ew160p@nih.gov>     | <ss433y@nih.gov>     |
| <http:                |                      |                      |
| //www.niams.nih.gov/> |                      | Mr. Erik (Timothy)   |
|                       |                      | Edgerton\            |
|                       |                      | Phone: 301-594-3968\ |
|                       |                      | Fax: 301-480-5450\   |
|                       |                      | Email:               |
|                       |                      | <te62m@nih.gov>      |
+-----------------------+----------------------+----------------------+
| National Institute of | Mr. Todd Merchak\    | Ms. Florence Turska\ |
| Biomedical Imaging    | Phone: 301-496-8592\ | Phone: 301-496-9314\ |
| and Bioengineering    | Fax: 301-480-1614\   | Fax: 301-480-4974\   |
|                       | Email:               | Email:               |
| <http:                | <tm311u@nih.gov>     | <ft7p@nih.gov>       |
| //www.nibib.nih.gov/> |                      |                      |
+-----------------------+----------------------+----------------------+
| National Cancer       | Mr. Michael          | Ms. Rosemary Ward\   |
| Institute             | Weingarten\          | Phone: 301-496-3182\ |
|                       | Phone: 301-594-7709\ | Fax: 301-496-8662\   |
| [http:/               | Fax: 301-480-4082\   | Email:               |
| /sbir.cancer.gov](htt | Email:\              | <w                   |
| p://sbir.cancer.gov/) | <weing               | ardros@mail.nih.gov> |
|                       | artenm@mail.nih.gov> |                      |
+-----------------------+----------------------+----------------------+
| *Eunice Kennedy       | Louis A. Quatrano,   | Mr. Ted Williams\    |
| Shriver*\             | Ph.D.\               | Phone: 301-          |
| National Institute of | Phone: 301-402-4221\ | 435-6996\            |
| Child Health and      | Fax: 301-402-0832\   | Fax: 301- 451-5510\  |
| Human Development     | Email:               | Email:               |
|                       | <lq2n@mail.nih.gov>  | <wi                  |
| [http://www           |                      | lliate@mail.nih.gov> |
| .nichd.nih.gov](http: |                      |                      |
| //www.nichd.nih.gov/) |                      |                      |
+-----------------------+----------------------+----------------------+
| National Institute on | Dr. Cathrine Sasek\  | Ms. Diana Haikalis,  |
| Drug Abuse            | Phone: 301-443-6071\ | M.B.A.\              |
|                       | Fax: 301-443-6277\   | Phone: 301-443-6710\ |
| [http://w             | Email:               | Fax: 301-594-6849\   |
| ww.nida.nih.gov](http | <cs106o@nih.gov>     | Email:               |
| ://www.nida.nih.gov/) |                      | <dh84m@nih.gov>      |
+-----------------------+----------------------+----------------------+
| National Institute on | Dr. Roger Miller\    | Mr. Christopher P.   |
| Deafness and Other    | Phone: 301-402-3458\ | Myers\               |
| Communication         | Fax: 301-402-6251\   | Phone: 301-402-0909\ |
| Disorders             | Email:               | Fax: 301-402-1758\   |
|                       | <mi                  | Email:               |
| [http://www           | llerr@nidcd.nih.gov> | <cm143g@nih.gov>     |
| .nidcd.nih.gov](http: |                      |                      |
| //www.nidcd.nih.gov/) |                      |                      |
+-----------------------+----------------------+----------------------+
| National Institute of | Dr. R. Dwayne        | Ms. Mary Daley\      |
| Dental and            | Lunsford\            | Phone: 301-594-4808\ |
| Craniofacial Research | Phone: 301-594-2421\ | Fax: 301-480-3562\   |
|                       | Fax: 301-480-8319\   | Email:               |
| [http://www           | Email:               | <md74u@nih.gov>      |
| .nidcr.nih.gov](http: | <rl332k@nih.gov>     |                      |
| //www.nidcr.nih.gov/) |                      |                      |
+-----------------------+----------------------+----------------------+
| National Institute of | Dr. Sanford A.       | Ms. Helen Y. Ling\   |
| Diabetes and          | Garfield\            | Phone: 301-594-8857\ |
| Digestive and Kidney  | Phone: 301-594-8803\ | Fax: 301-480-3504\   |
| Diseases              | Fax: 301-402-6271\   | Email:               |
|                       | Email:               | <hl12d@nih.gov>      |
| [http://www           | <sg50o@nih.gov>      |                      |
| .niddk.nih.gov](http: |                      |                      |
| //www.niddk.nih.gov/) |                      |                      |
+-----------------------+----------------------+----------------------+
| National Institute of | Dr. Jerrold Heindel\ | Ms. Pam Clark\       |
| Environmental Health  | Phone: 919-541-0781\ | Phone: 919-541-7629\ |
| Sciences              | Fax: 919-541-5064\   | Fax: 919-541-2860\   |
|                       | Email:               | Email:               |
| [http://www           | <jh190f@nih.gov>     | <e                   |
| .niehs.nih.gov](http: |                      | vans3@niehs.nih.gov> |
| //www.niehs.nih.gov/) |                      |                      |
+-----------------------+----------------------+----------------------+
| National Eye          | Dr. Jerome Wujek\    | Mr. William Darby\   |
| Institute             | Phone: 301-451-2020\ | Phone: 301-451-2020\ |
|                       | Fax: 301-402-0528\   | Fax: 301-496-9997\   |
| [http:/               | Email:               | Email:               |
| /www.nei.nih.gov](htt | <jw513y@nih.gov>     | <wwd@nei.nih.gov>    |
| p://www.nei.nih.gov/) |                      |                      |
+-----------------------+----------------------+----------------------+
| National Institute of | Dr. Matthew Portnoy\ | Ms. Patrice Molnar\  |
| General Medical       | Phone: 301-594-0943\ | Phone: 301-594-5136\ |
| Sciences              | Fax: 301-480-2228\   | Fax: 301-480-2554\   |
|                       | Email:               | Email:               |
| <http:                | <mp371e@nih.gov>     | <pm32e@nih.gov>      |
| //www.nigms.nih.gov/> |                      |                      |
+-----------------------+----------------------+----------------------+
| National Heart, Lung, | Ms. Susan Pucie\     | Mr. Robert Vinson\   |
| and Blood Institute   | Phone: 301-435-0079\ | Phone: 301-435-0166\ |
|                       | Fax: 301-480-0867\   | Fax: 301-451-5462\   |
| [http://www           | Email:               | Email:               |
| .nhlbi.nih.gov](http: | <sp34j@nih.gov>      | <rv7g@nih.gov>       |
| //www.nhlbi.nih.gov/) |                      |                      |
+-----------------------+----------------------+----------------------+
| National Human Genome | Dr. Bettie J.        | Ms. Cheryl Chick\    |
| Research Institute    | Graham\              | Phone: 301-435-7858\ |
|                       | Phone: 301-496-7531\ | Fax: 301-402-1951\   |
| [http                 | Fax: 301-480-2770\   | Email:               |
| ://www.genome.gov](ht | Email:               | <cc149o@nih.gov>     |
| tp://www.genome.gov/) | <bg30t@nih.gov>      |                      |
+-----------------------+----------------------+----------------------+
| National Institute of | Dr. Michael F.       | Ms. Rebecca          |
| Mental Health         | Huerta\              | Claycamp\            |
|                       | Phone: 301-443-3563\ | Phone: 301-443-2811\ |
| [http://w             | Fax: 301-443-1731\   | Fax: 301-443-6885\   |
| ww.nimh.nih.gov](http | Email:               | Email:               |
| ://www.nimh.nih.gov/) | <mh38f@nih.gov>      | <rc253d@nih.gov>     |
+-----------------------+----------------------+----------------------+
| National Institute of | Dr. Randall Stewart  | Ms. Kimberly         |
| Neurological          |                      | Campbell\            |
| Disorders and Stroke  | Phone: 301-496-1917\ | Phone: 301-496-7809\ |
|                       | Fax: 301-402-1501\   | Fax: 301-402-0219\   |
| [http://www           | Email:               | Email:               |
| .ninds.nih.gov](http: | <rs416y@nih.gov>     | <kc274k@nih.gov>     |
| //www.ninds.nih.gov/) |                      |                      |
+-----------------------+----------------------+----------------------+
| National Institute of | Dr. Paul A. Cotton\  | Mr. Brian Albertini\ |
| Nursing Research      | Phone: 301-402-6423\ | Phone: 301-594-6869\ |
|                       | Fax: 301-480-8260\   | Fax: 301-402-4502\   |
| <htt                  | Email:               | Email:               |
| p://www.nih.gov/ninr> | <pc272a@nih.gov>     | <ba18b@nih.gov>      |
+-----------------------+----------------------+----------------------+
| National Center for   | Dr. Amy Swain\       | Ms. Leslie Le\       |
| Research Resources    | Phone: 301-435-0755\ | Phone: 301-435-0856\ |
|                       | Fax: 301-480-3659\   | Fax: 301-480-3777\   |
| [http://w             | Email:               | Email:               |
| ww.ncrr.nih.gov](http | <as387d@nih.gov>     | <ld40e@nih.gov>      |
| ://www.ncrr.nih.gov/) |                      |                      |
+-----------------------+----------------------+----------------------+
| National Center for   | Dr. Carol Pontzer\   | Mr. George Tucker,   |
| Complementary and     | Phone: 301-435-6286\ | MBA\                 |
| Alternative Medicine  | Fax: 301-480-3621\   | Phone: 301-594-8853\ |
|                       | Email:               | Fax: 301-480-1552\   |
| <http:                | <cp253q@nih.gov>     | Email:               |
| //www.nccam.nih.gov/> |                      | <gt35v@nih.gov>      |
+-----------------------+----------------------+----------------------+
| National Center on    | Mr. Vincent Thomas,  | Ms. Priscilla Grant, |
| Minority Health and   | MSW, MPA\            | J.D., C.R.A.\        |
| Health Disparities    | Phone: 301-402-2516\ | Phone: 301-594-8412\ |
|                       | Fax: 301-480-4049\   | Fax: 301-480-4049\   |
| [http://www           | Email:               | Email:               |
| .ncmhd.nih.gov](http: | <vt5e@nih.gov>       | <pg38h@nih.gov>      |
| //www.ncmhd.nih.gov/) |                      |                      |
+-----------------------+----------------------+----------------------+
| National Library of   | Dr. Jane Ye\         | Mr. Dwight Mowery\   |
| Medicine              | Phone: 301-594-4882\ | Phone: 301-496-4221\ |
|                       | Fax: 301-402-2952\   | Fax: 301-402-0421\   |
| [http:/               | Email:               | Email:               |
| /www.nlm.nih.gov](htt | <yej@mail.nih.gov>   | <m                   |
| p://www.nlm.nih.gov/) |                      | oweryd@mail.nih.gov> |
+-----------------------+----------------------+----------------------+
| Centers for Disease   | Dr. Brenda Colley    | Mr. Hector A.        |
| Control and           | Gilbert\             | Buitrago\            |
| Prevention (CDC)      | (CoCHP)\             | (CoCHP)\             |
|                       | Phone: 770-488-8390\ | Phone: 770-488-2921\ |
| [http://www.cdc.gov]  | Fax: 770-488-8046\   | Fax: 770-488-2777\   |
| (http://www.cdc.gov/) | Email:               | Email:               |
|                       | <bjc4@cdc.gov>       | <HBuitrago@cdc.gov>  |
|                       |                      |                      |
|                       | Ms. Sheila Jones     | Ms. Tracey Coleman   |
|                       | (CoCHP)\             | (NCIPC)\             |
|                       | Phone: 770-488-6426\ | Phone: 770-488-2074\ |
|                       | Fax: 770-488-8046\   | Fax: 770-488-2670\   |
|                       | Email:               | Email:               |
|                       | <slj1@cdc.gov>       | <apf4@cdc.gov>       |
|                       |                      |                      |
|                       | Dr. Paul Smutz       | Ms. Nealean Austin   |
|                       | (NCIPC)\             | (NCHS)\              |
|                       | Phone: 770-488-1508\ | Phone: 770-488-2771\ |
|                       | Fax: 770-488-1665\   | Fax: 770-488-2777\   |
|                       | Email:               | Email:               |
|                       | <wsmutz@cdc.gov>     | <neal@cdc.gov>       |
|                       |                      |                      |
|                       | Dr. Virginia Cain    | Ms. Nealean Austin   |
|                       | (NCHS)\              | (NCPHI)\             |
|                       | Phone: 301-458-4395\ | Phone: 770-488-2771\ |
|                       | Fax: 301-458-4020\   | Fax: 770-488-2777\   |
|                       | Email:               | Email:               |
|                       | <vxc6@cdc.gov>       | <neal@cdc.gov>       |
|                       |                      |                      |
|                       | Dr. Lee Husting      | Mr. Larry Guess      |
|                       | (NCPHI)\             | (NIOSH)\             |
|                       | Phone: 404-498-1186\ | Phone: 412-386-6826\ |
|                       | Email:               | Fax: 412-386-6429\   |
|                       | <eih8@cdc.gov>       | Email:               |
|                       |                      | <lguess@cdc.gov>     |
|                       | Ms. Susan Board      |                      |
|                       | (NIOSH)\             | Ms. Tracey Coleman   |
|                       | Phone: 404-498-2530\ | (NCEH)\              |
|                       | Fax: 404-498-2569\   | Phone: 404-488-2074\ |
|                       | Email:               | Fax: 404-488-2688\   |
|                       | <SBoard@cdc.gov>     | Email:               |
|                       |                      | <apf4@cdc.gov>       |
|                       | Dr. Paul Mehta       |                      |
|                       | (NCEH)\              | Ms. Nealean Austin\  |
|                       | Phone: 770-488-0556\ | (COTPER)\            |
|                       | Fax: 770-488-1665\   | Phone: 770-488-2771\ |
|                       | Email:               | Fax: 770-488-2777\   |
|                       | <pum4@cdc.gov>       | Email:               |
|                       |                      | <neal@cdc.gov>       |
|                       | Dr. Mildred          |                      |
|                       | Williams-Johnson     | Ms. Sharron Orum     |
|                       | (COTPER)\            | (CCID)\              |
|                       | Phone: 404-639-7719\ | Phone: 770-488-2716\ |
|                       | Fax: 404-639-7977\   | Fax: 770-488-2777\   |
|                       | Email:               | Email:               |
|                       | <MWilli              | <sorum@cdc.gov>      |
|                       | ams-Johnson@cdc.gov> |                      |
|                       |                      |                      |
|                       | Dr. Barbara Stewart  |                      |
|                       | (CCID)\              |                      |
|                       | Phone: 404-498-2770\ |                      |
|                       | Fax: 404-498-2469\   |                      |
|                       | Email:               |                      |
|                       | <bstewart@cdc.gov>   |                      |
+-----------------------+----------------------+----------------------+
| Food and Drug         | Ms. Michelle Hawley\ | Ms. Gladys           |
| Administration (FDA)  | Phone: 301-827-1991\ | Melendez-Bohler\     |
|                       | Fax: 301-827-7101\   | Phone: 301-827-7168\ |
| [http://www.fda.gov]  | Email:               | Fax: 301-827-7101\   |
| (http://www.fda.gov/) | <michelle            | Email:               |
|                       | .hawley@fda.hhs.gov> | <Gladys.Melendez     |
|                       |                      | -Bohler@fda.hhs.gov> |
+-----------------------+----------------------+----------------------+
| Administration for    | Anne F. Bergan\      | Edeltraud Fernandez\ |
| Children and Families | Phone: 202-260-8515\ | Phone: 202-401-2346\ |
|                       | Fax: 202-205-3598\   | Fax: 202-205-3598\   |
| [http:/               | E-mail:              | E-mail:              |
| /www.acf.hhs.gov](htt | <                    | <efe                 |
| p://www.acf.hhs.gov/) | abergan@acf.hhs.gov> | rnandez@acf.hhs.gov> |
+-----------------------+----------------------+----------------------+

[]{#__RefHeading___Toc219687035 .anchor}National Institute on Aging
(NIA)

The NIA SBIR-STTR Programs support 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 SBIR and STTR grant research under four established divisions:
Behavioral and Social Research, Aging Biology, Geriatrics and Clinical
Gerontology, and Neuroscience.

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___Toc219687036 .anchor}Division of 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 (1) Health Disparities; (2)
Aging Minds; (3) Increasing Health Expectancy; (4) Health, Work, and
Retirement; (5) Interventions and Behavior Change; (6) Genetics,
Behavior, and the Social Environment; and (7) the Burden of Illness and
the Efficiency of Health Systems.

NIA has supported many training videos for programs or interventions
through the SBIR/STTR grant mechanism in the past. NIA is currently less
interested in training videos, especially for programs or interventions
that have not been evaluated in large-scale trials.

A. Social, behavioral, environmental and or/technical interventions on
the individual, institutional, family, community or national level
intended to maintain older adult independence or functioning, increase
well-being and prevent disease and/or disability. Interventions that
impact risk factors associated with health disparities both between and
within groups are encouraged. Multi-level interventions are encouraged.
Interventions are encouraged for home, community, healthcare or
workplace settings. More information about the use of multi-level
methodology in the social and behavioral sciences can be found in *New
Horizons in Health: an Integrative Approach*
(<http://books.nap.edu/openbook/0309072964/html/index.html>), and
*Promoting Health: Intervention Strategies from Social and Behavioral
Research* (<http://books.nap.edu/catalog.php?record_id=9939#toc>).

1\. Cognitive, social, behavioral, environmental, and human factors
interventions to address cognitive aging, either to limit or delay
cognitive declines associated with aging, as well as the progression of
diseases impacting cognitive status, such as Alzheimer's disease.
Examples are training programs or interventions that impact daily
activities to enhance cognitive activity.

2\. Interventions directed at self-management of chronic diseases among
the elderly, including behavioral change and applications to enhance
compliance. Examples include the development of strategies and
technology to enhance long-term adherence to medical regimes for chronic
conditions, and behavior-change interventions for health promotion in
older adults. Advances might target the healthcare provider (including
pharmacists and other non-hospital-based providers), caregiver or
patient, or a larger group, such as a social network.

3\. Interventions to enhance social function (e.g., work, civic
participation, and other aspects of social life) or to improve physical
and psychological well-being in midlife and older age. Interventions
might target employers, employee organizations, social organizations or
networks, or individuals.

Dr. Rosie Sood

301-402-4156, Fax: 301-402-0051

Email: <soodjr@mail.nih.gov>

4\. The development of risk-reduction programs (also referred to as
health promotion, health management, demand management, and
disease-prevention programs) that have been tested in the private sector
and applied to older U.S. workers. (see:
<http://www.cms.hhs.gov/DemoProjectsEvalRpts/downloads/Senior_Risk_Reduction_Evidence_Report.pdf>).

Dr. John Phillips

301-496-3138, Fax: 301-402-0051

Email: <phillipj@mail.nih.gov>

B. The development of tools to improve financial decision making among
older people. Examples include tools on portfolio allocation for
retirement decisions based on approaches from research on portfolio
theory; tools to increase financial and health literacy, numeracy and
quantitative judgment based on approaches from research on cognition;
and products for retirement income, including reverse mortgages,
annuities and long term care products.

Dr. John Phillips

301-496-3138, Fax: 301-402-0051

Email: <phillipj@mail.nih.gov>

C. The development of practical applications using innovative
technologies (e.g. hand-held, internet, telemedicine GPS, robotics,
social networking and communications technologies) to support and
improve quality of life, well-being, and the ability of older adults to
live independently and safely at home. Examples include systems and
devices to: evaluate, monitor and improve mobility; improve health
service delivery to elders; support independent living and the conduct
of everyday tasks at home; provide information to health care providers
and family members with which to evaluate the need for intervention; and
promote communication and interaction between older people living in the
community or in institutional settings and their health care providers,
friends and family members.

Ms. Georgeanne E. Patmios

301-496-3138, Fax: 301-402-0051

Email: <PatmiosG@nia.nih.gov>

D. Interventions or programs for issues impacting caregivers of the
elderly and older individuals needing long-term care.

1\. Development of strategies for care providers (both professionals and
families) to deal with burdens associated with chronic disabling illness
or disease (including Alzheimer's disease). Interventions could include
new forms of adult day care and family interventions.

2\. Programs or interventions that address/decrease the trauma and
difficulty of elders, their families, and care providers faced with end
of life decisions and events that surround the end of life.

Dr. Rosie Sood

301-402-4156, Fax: 301-402-0051

Email: <soodjr@mail.nih.gov>

E. New sampling and data collection methodologies for use in large
population-based household surveys and behavioral interventions. These
include: experience sampling or other methods for measuring affect,
stress experience/exposures, and psychological well-being; performance
based measures for cognitive or physical functioning; new instruments
for cognitive testing; new devices for real-time collection of data; and
improvements to blood spot technology for biological data collection
(this includes the development of multiple assays for limited blood spot
specimens).

Dr. Rosie Sood

301-402-4156, Fax: 301-402-0051

Email: <soodjr@mail.nih.gov>

F. Survey Development/Archiving/Database support. Complex and
large-scale socio-behavioral surveys related to adult health and aging
are being developed all over the world. This has spurred demand for new,
innovative technologies such as, incorporation of biological and
physiological measures, and user-friendly longitudinal databases
Longitudinal surveys often become more difficult to use over time due to
increased complexity in the composition of the sample and/or the
addition of new survey components, coupled with inconsistent data files
and inadequate documentation, and confidentiality concerns. Information
on NIA-supported datasets in the social and behavioral sciences can be
found at: [http://www.nia.nih.gov/Research
Information/ExtramuralPrograms/BehavioralAndSocialResearch/Resources.htm](http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/Resources.htm).

1\. Development of new databases (e.g., linkages of self-report and
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, policy analysts, insurers and the health care
industry. An example is software for creating ex-post harmonized data
extracts for cross-national analyses using comparable international
longitudinal aging databases.

2\. Development of data extraction web tools for public use databases,
such as for the Health and Retirement Study (HRS), the National
Long-Term Care Survey (NLTCS), and the National Survey of Midlife
Development in the United States (MIDUS). For example, the Panel Study
of Income Dynamics (PSID) \[see
[http://simba.isr.umich.edu](http://simba.isr.umich.edu/)\] and the
Medical Expenditure Panel Survey (MEPS) \[see
<http://www.meps.ahrq.gov/mepsweb/data_stats/download_data_files.jsp>\]
offer web tools which enable users to download variables and codebooks
customized to their research interests.

3\. Development of innovative methods and software to provide improved
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.

4\. Development of innovative methods and software to facilitate
analysis of personal data linked to geocoded data, biological, cognitive
or genetic measures, with improved protection for confidentiality of
respondents.

Dr. Partha Bhattacharyya

301-496-3138, Fax: 301-402-0051

Email: <BhattacharyyaP@nia.nih.gov>

G. 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
take into account health, intergenerational transfers, changes in family
composition, and other characteristics of future cohorts. Both domestic
and international projections are of interest.

Ms. Georgeanne E. Patmios

301-496-3138, Fax: 301-402-0051

Email: <PatmiosG@nia.nih.gov>

[]{#__RefHeading___Toc219687037 .anchor}Division of Aging Biology

Research on the physiological, molecular, and cellular causes and
consequences 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. Felipe Sierra

301-496-6402, Fax: 301-402-0010

Email: <sierraf@mail.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. These would
include devices, processes, and pharmacological agents with the
potential to (1) promote would healing in aged tissues such as skin,
muscle, cartilage, and bone, or (2) reduce scar formation without
compromising effective healing. Wounds produced by accidental damage or
resulting from surgery would be appropriate for consideration.

Dr. Ronald Kohanski

301-496-6402, Fax: 301-402-0010

Email: <kohanskir@mail.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 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. Rebecca Fuldner

301-496-6402, Fax: 301-402-0010

Email: <fuldnerr@mail.nih.gov>

or

Dr. Felipe Sierra

301-496-6402, Fax: 301-402-0010

Email: <sierraf@mail.nih.gov>

J. Development of cell-based therapies or other treatments to repair
myocardial or vascular tissues after ischemia. The work should include
consideration of age-related effects on the therapy or treatment.

Dr. Ronald Kohanski

301-496-6402, Fax: 301-402-0010

Email: <kohanskir@mail.nih.gov>

[]{#__RefHeading___Toc219687038 .anchor}Division of Neuroscience

This division supports 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, sleep and
circadian rhythms, immune, disease states); degenerative processes or
pathological changes in the aging brain in the context of understanding
normal age-related changes; and the sensory, motor, perceptual and
cognitive processes and changes that occur with aging as related to
their underlying biological mechanisms.

An important component of this division 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 or natural
products, delivery systems, or treatments to enhance cognitive
functioning in normal aging and to treat the cognitive deterioration
and/or behavioral symptoms associated with mild cognitive impairment and
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. Behavioral, environmental, or nutritional interventions to restore
brain biochemical changes in aging and neurodegenerative diseases.

E. Biosensors and prosthetic devices, technologies, and related software
development to aid in the assessment, diagnosis, and remediation of
age-related cognitive decline or sensory dysfunction (including pain),
motor dysfunction (including Parkinson's disease and other motor
disorders of aging), or age-related changes in balance, postural
control, and gait. Novel markers of normal age-dependent cognitive
decline or sensory and/or motor system changes at the molecular
cellular, circuitry, physiological or behavioral level in humans or
relevant animal models.

Dr. Wen G. Chen

301-496-9350, Fax: 301-496-1494

Email: <chenw@mail.nih.gov>

and/or

Dr. Molly Wagster

301-496-9350, Fax: 301-496-1494

Email: <wagsterm@mail.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.

G. Minimally invasive technologies to detect prion diseases early in the
course of the disease process in older adults, as well as effective
treatment strategies to slow, halt or prevent these diseases.

Dr. Andrew Monjan

301-496-9350, Fax: 301-496-1494

Email: <am39m@nih.gov>

H. 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 animals.

Dr. Molly Wagster

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

Email: <mw203d@nih.gov>

I. 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.

J. Development of technology, including non-invasive methods and novel
probes, to monitor and manipulate the plasticity of neural circuits in
the adult and aged nervous system. Development of novel markers of
neural stem cell function (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, Fax: 301-496-1494

Email: <ss82f@nih.gov>

[]{#__RefHeading___Toc219687039 .anchor}Division of Geriatrics and
Clinical Gerontology

The Division of Geriatrics and Clinical Gerontology (DGCG) 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. 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.

Dr. Susan Nayfield

301-496-6761, Fax: 301-402-1784

Email: <nayfiels@nia.nih.gov>

B. 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.

C. 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.

D. 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>

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

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

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

Dr. Chhanda Dutta

301-435-3048, Fax: 301-402-1784

Email: <cd23z@nih.gov>

H. 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.

I. Improved instrumentation, e.g., accelerometers, for assessment of
ambulation and falls.

J. 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
persons; (2) to assist in teaching older persons how to conduct
self-examinations for early warning signs of cancer; (3) to teach older
persons (patients) how to care for themselves after undergoing cancer
surgery, e.g., ostomy patients.

4\. Development of methods that assist in the provision of guidance to
physicians to estimate proper medication dosage in older cancer patients
given their body composition, body size, age, other health problems,
kidney function, and other relevant physiological parameters. Such
methods and guidance would include estimates of initial or loading doses
of therapeutic drugs and daily maintenance to ensure the sustainment of
therapeutic drug levels in the older patients' bloodstream.

K. Research on better ways to prevent injuries and deaths associated
with the use of currently-available bed rails in populations of older
patients. Such research would include work on their identification and
testing of improved designs of bed systems for use in homes, skilled
nursing facilities, and hospitals.

L. Techniques for preventing or treating urinary incontinence.

Dr. Susan Nayfield

301-496-6761, Fax: 301-402-1784

Email: <nayfiels@nia.nih.gov>

M. Development of methods to accurately determine the renal glomerular
filtration rate (GFR) in older persons and patients with chronic kidney
disease. The new methods should justify the effects of age-related
changes in muscle mass, levels of serum creatinine, renal blood flow and
renal concentrating ability.

N. Identification of novel biomarkers of acute kidney injury and chronic
kidney disease in older persons. Such research would include
identification of biomarkers and development of techniques to use these
biomarkers for early diagnosis, prediction of the course of progression
of diseases and monitoring the effects of treatment,

O. Development and validation of new technology such as non-invasive
methods to examine blood-flow velocity in arteries, individual coronary
arteries, renal arteries, and cerebral arteries.

Dr. Ying Tian

301-496-6761, Fax: 301-402-1784

Email: <tiany@nia.nih.gov>

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

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

Ms. Winifred Rossi, M.A.

301-496-3836, Fax: 301-402-1784

Email: <wr33a@nih.gov>

[]{#__RefHeading___Toc219687040 .anchor}Phase II Competing Renewal
Awards

NIA accepts Phase II Competing Renewal grant applications from Phase II
SBIR/STTR awardees to continue the process of developing products,
primarily for pharmaceutical compounds and medical devices, requiring
approval by the Food & Drug Administration (FDA). NIA will accept
applications for up to two (2) years and up to \$750,000 per year in
total costs. The Phase II Competing Renewal award is intended to allow
small businesses the opportunity to advance research to a stage where
interest in and investment by third parties would be more likely.

Prospective Phase II Competing Renewal applicants are encouraged to
submit a letter of intent to Dr. Kerns 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

-   Anticipated Budget

-   Participating institutions

-   Funding Opportunity Announcement Number (e.g., PA-09-XXX, if
    relevant)

Although a letter of intent is not binding and does not enter into the
review of a subsequent application, it allows NIA staff to estimate the
potential review workload, plan the review, and consider budget
implications. It is anticipated that only a small number of NIA
SBIR/STTR Phase II awards would be eligible for a Phase II Competing
Renewal award.

The following examples would make appropriate topics for Phase II
Competing Renewal projects. These are meant only as indications of
potential Phase II Competing Renewal projects and are not exclusive of
other appropriate activities. Research and development efforts can be
focused, for example, on medications to treat, delay the progression of
or prevent age-related cognitive decline, mild cognitive impairment
(MCI), 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 compound, 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 ("M-D") A.R.R. Kerns

301-402-7713, Fax: 301-402-2945

Email: kernsmd@mail.nih.gov

[]{#__RefHeading___Toc219687041 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics and administrative
questions, contact:

Dr. Michael-David ("M-D") A.R.R. Kerns

Health Scientist Administrator

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: <michael-david.kerns@nih.hhs.gov>

For 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___Toc219687042 .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___Toc219687043 .anchor}Phase II Competing Renewal
Awards

NIAAA will accept competing renewal Phase II SBIR/STTR 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, 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.

Please contact Dr. Max Guo (contact information provided below) 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-09-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:

Q. Max Guo, Ph.D.

Telephone: 301-443-0639

Fax: 301-594-0673

Email: <QG7S@nih.gov>

[]{#__RefHeading___Toc219687044 .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 attenuate
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, cardiomyopathy, or other alcohol-induced tissue
damage.

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. (Neuroscience and behavior)

301-594-6382

Email: <me114r@nih.gov>

Svetlana Radaeva, Ph.D. (Organ damage)

301-433-1189

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

[]{#__RefHeading___Toc219687045 .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___Toc219687046 .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___Toc219687047 .anchor}Alcohol Biosensors and Data
Analysis Systems

It is anticipated that innovative and improved alcohol sensors would be
useful in a variety of situations including, but not limited to:
clinical monitoring, forensics and human or animal research. Specific
sensor characteristics would complement their intended use. This applies
to characteristics such as: sampling frequency, degree of accuracy, data
storage capacity and data transmission frequency.

Depending on their intended purpose and use, alcohol sensors may be
augmented with additional information such as other physiological
measurements or geospatial determinations.

Devices need to be compatible with human comfort, and devices to be worn
for weeks or months may present particular challenges. Since alcohol
readings are likely to be baseline most of the time, sensing devices
generally require ways to monitor contact and readiness to record.
Moreover, where necessary, measurement fidelity should be robust to
subject\'s activities including active efforts at tampering.

The mode of data storage will need to conform to power limitations and
strategies for data transmission which may require telemetry.

In addition to alcohol monitoring and data transmission this program
also includes the opportunity to develop appropriate data analysis
systems. Examples include: estimating blood alcohol concentrations,
reconstructing patterns of alcohol consumption, and monitoring large
numbers of devices to identify significant, but infrequent, events while
minimizing false positives.

R. Thomas Gentry, Ph.D.

301-443-6009

Email: <tgentry@niaaa.nih.gov>

[]{#__RefHeading___Toc219687048 .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___Toc219687049 .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___Toc219687050 .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 protocols to assist in the identification,
recruitment, and selection of treatment personnel to enhance the
matching of staff to program needs.

B. 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.

C. Development of software to assist clinicians in scoring and norming
of commonly used assessment instruments. These packages should include
protocols for guiding client feedback in a clinic or office-based
setting.

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

E. Development of protocols to facilitate the selection, implementation,
adoption, and maintenance of evidence-based services consistent with
target population need, staffing and program resources, and expected
outcomes. These protocols should be flexible enough to work across a
variety of settings and modalities.

F. 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, medical management, effective referral to
specialized alcohol treatment, and follow-up.

G. Development of software or other protocols for monitoring service
costs of alcohol treatment services including core, ancillary,
out-sourced 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___Toc219687051 .anchor}Fetal Alcohol Syndrome (FAS) and
Alcohol-Related Birth Defects

FASD is the collective term for the broad array of documented adverse
effects resulting from in utero alcohol exposure. The most serious of
these is fetal alcohol syndrome (FAS), a devastating developmental
disorder characterized by craniofacial abnormalities, growth
retardation, and nervous system impairments that may include mental
retardation. Other diagnostic categories include partial FAS,
alcohol-related neurodevelopmental disorder (ARND), and alcohol-related
birth defects (ARBD). Children and adults with FASD may exhibit multiple
cognitive, behavioral, and emotional deficits that impair daily
functioning in many domains. 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 biomarkers that can be used to verify
prenatal alcohol exposure in neonates.

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

D. Development and testing of skill-building, therapeutic, and education
program products that enhance the social, cognitive, adaptive and motor
abilities of individuals with FASD.

E. Development of neurobehavioral tools or instruments to assess
responsiveness of individuals with FASD to medications and/or
cognitive/behavioral therapies.

F. 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.

G. 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.

H. Development and validation of innovative approaches to prevent
harmful drinking during pregnancy.

For basic research questions, contact:

Dale Hereld, MD, Ph.D.

301-443-0912

Email: <hereldd@mail.nih.gov>

For prevention research questions, contact:

Marcia Scott, Ph.D.

301-402-6328

Email: <mscott@mail.nih.gov>

[]{#__RefHeading___Toc219687052 .anchor}Alcohol Use and HIV, HBV, or HCV
Infection

Alcohol use, including hazardous drinking, by persons infected with HIV,
HBV, and HCV, is quite common in the United States. Alcohol consumption
is widely acknowledged as a co-factor in the sexual transmission,
susceptibility to infection, and progression of the infectious diseases.
However, detailed relationships between alcohol use and viral
infections, diseases progression, antiretroviral therapy and adverse
outcomes, notably in liver disease progression, are less recognized or
understood. Recent research indicates that inflammatory pathways
predominate in alcoholic hepatitis whereas adaptive immunity plays a
primary role in viral hepatitis, offering multiple targets for novel
preventive and therapeutic interventions. Comprehensive studies to
improve understanding of the factors underlying alcohol and viral
etiologies in liver disease and the impact of antiretroviral drugs on
liver disease progression are needed. A better understanding of
alcohol's effects on liver disease in patients with HIV/HBV/HCV
infection may improve diagnosis and treatment outcomes. NIAAA supports
research leading to improved diagnosis and treatment of alcohol-induced
disorders in people infected with HIV, HBV, or HCV. Areas that may be of
interest to small businesses include, but are not limited to:

A. New preventive and therapeutic approaches designed to protect the
liver from alcohol and antiretroviral drug-induced liver injury in
patients infected with HIV, HBV, or HCV

B. Development of therapies aimed at molecular targets that play a role
in the development of alcoholic and viral liver diseases

C. Develop and implement drugs that mitigate the effects of oxidative
stress on mitochondrial function thereby preventing liver disease
progression

D. Development of biomarkers for individuals who are most prone to
alcohol-induced damage in those patients infected with HIV, HBV, or HCV.

For HBV/HCV and basic research questions, contact:

H. Joe Wang, Ph.D.

301-451-0747

Email: <wangh4@mail.nih.gov>

For clinical or epidemiological questions on HIV, contact:

Kendall J. Bryant, Ph.D.

301-402-9389

Email: <kbryant@mail.nih.gov>

[]{#__RefHeading___Toc219687053 .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.

Gregory Bloss

301-443-3865

Email: <gbloss@mail.nih.gov>

[]{#__RefHeading___Toc219687054 .anchor}Research Tools

The NIAAA supports the development of new or improved tools to enhance
the ability to conduct alcohol-related laboratory studies on humans and
animals and to more effectively analyze data from large databases.
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 novel 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.

G. Development of genetic, genomic, or functional genomic tools or
resources for prognosis, diagnosis, or treatment of alcohol-induced
disorders.

H. Development of computational, statistical or bioinformatics tools to
organize and manage high throughput data obtained by genomic or
functional genomic strategies.

I. Development of databases, methods for integration of databases, or
data analysis systems for alcohol research.

J. Development of non-invasive or minimally invasive alcohol detection
biosensors with sensitivity and specificity appropriate for laboratory
research with humans or animals (see also Alcohol Biosensors and Data
Analysis Systems).

Kathy Jung, Ph.D.

301-443-8744

Email: <jungma@mail.nih.gov>

[]{#__RefHeading___Toc219687055 .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-glutamyl
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:

Kathy Jung, Ph.D.

301-433-8744

Email: <jungma@mail.nih.gov>

[]{#__RefHeading___Toc219687056 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Q. Max Guo, Ph.D.

National Institute on Alcohol Abuse and Alcoholism

5635 Fishers Lane, Room 2037

Bethesda, MD 20892-9304

For Federal Express delivery, use:

Rockville, MD 20852-1705

Phone: 301-443-0639

Email: <QG7S@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___Toc219687057 .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 Programs, please visit
<http://www.niaid.nih.gov/ncn/sbir>.

**Limited Amount of Award (Total not Annual)**

For budgetary or programmatic reasons, NIAID may decrease the length of
an award or the amount of an award recommended by a review committee.
Applicants considering requesting a Phase I grant greater than \$300,000
total cost or a Phase II grant greater than \$2 million total cost are
strongly encouraged to contact Gregory Milman (below) before submitting
an application.

[]{#__RefHeading___Toc219687058 .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, and subcontracts to assure compliance with
Good Manufacturing Practices expectations of the FDA.

Human clinical trials may not be a component of proposed SBIR or STTR
research. NIAID will only support investigator-initiated clinical trials
through a two part grant process: (1) a clinical trial planning grant
(<http://grants.nih.gov/grants/guide/pa-files/PAR-06-384.html>) followed
by (2) a clinical trial implementation cooperative agreement
(<http://grants.nih.gov/grants/guide/pa-files/PAR-05-113.html>). Small
business applicants are encouraged to contact Gregory Milman (below) to
discuss NIAID funding for human clinical trials.

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

Gregory Milman, Ph.D.

Division of Extramural Activities

National Institute of Allergy and Infectious Diseases

Room 2130, 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___Toc219687059 .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. Carl Dieffenbach

301-496-0545

Email: <cd17u@nih.gov>

Biostatistics Research Branch

Stimulate innovative research in statistical methods to advance the
study of HIV/AIDS vaccines, therapies and pathogenesis.

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.

Acting Director: Dr. Susan Plaeger

301-496-0637

Email: <splaeger@niaid.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: Dr. Opendra Sharma

301-496-9041

Email: <osharma@niaid.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 Research Program

Supports the development of vaccines to prevent AIDS.

Director: Dr. Margaret (Peggy) Johnston

301-402-0846

Email: <pj7p@nih.gov>

A. ***[Vaccine Clinical Research and 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.

Contact: Dr. Jim Lane

301-451-2758

Email: <laneji@mail.nih.gov>

B. ***[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: <yli@niaid.nih.gov>

C. ***[Vaccine Discovery Branch.]{.underline}*** Research on: 1)
identification of optimal antigens for HIV vaccine design (e.g., epitope
mapping, epitope dominance, etc.); 2) identification of cellular
components or novel antigens created by env-host interactions as vaccine
targets; 3) development of innovative small animal models and in vitro
systems to assess immune responses to vaccines; and 4) novel innate and
mucosal immune pathways, adjuvants and immunomodulators to improve
vaccine responses.

Contact: Dr. Geetha Bansal

301-496-5042

Email: <gbansal@niaid.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.

Acting Director: Dr. Jeffrey Nadler

301-496-8210

Email: <nadlerj@niaid.nih.gov>

A. ***[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.

Chief: Dr. Mike Ussery

301-402-0134

Email: <mussery@niaid.nih.gov>

B. ***[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.

Contact: Daniella Livnat

301-435-3775

Email: <dlivnat@niaid.nih.gov>

C. ***[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, and
cryptococcosis. Research on metabolic complications of anti-retroviral
therapy, emergence of resistance to existing therapies and drug-drug
interactions.

Contact : Dr. Chris Lambros

301-435-3769

Email: <clambros@niaid.nih.gov>

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

Chief: Dr. Ed Handelsman

301-402-3221

Email: <handelsmane@niaid.nih.gov>

E. ***[Prevention Sciences Program.]{.underline}*** Conduct basic
research on mechanisms of HIV transmission supportive of new biomedical
strategies for interrupting transmission. 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.

Acting Director: Sheryl Zwerski, MSN, CRNP

301-402-4032

Email: <szwerski@niaid.nih.gov>

F. ***[Microbicide Research Branch.]{.underline}*** Basic research on
mechanisms of HIV transmission supportive of new biomedical strategies
for interrupting transmission. Translational research on microbicides,
spanning discovery and preclinical through pilot human clinical
research. Pilot clinical studies of the performance of microbicide
vehicles with regard to coverage of and persistence on mucosal surfaces,
potential biomarkers of safety, behavioral acceptability, and new
technology to evaluate safety.

Dr. Roberta Black

Chief Topical Microbicide Research Branch

301-496-8199

Email: <rblack@niaid.nih.gov>

[]{#__RefHeading___Toc219687060 .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, basic studies of asthma and allergy mechanisms,
new therapies to prevent or treat asthma and allergic diseases, food
allergies, epidemiology and prevention, phagocyte biology, eosinophilic
gastroenteritis, 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. Matthew Fenton

301-451-0144

Email: <fentonm@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, immune
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: 301-480-2381

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, and biomarkers, 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. Nancy Bridges

301-496-5598

Email: <nbridges@niaid.nih.gov>

E. ***[Radiation Countermeasures Program.]{.underline}***
Radioprotectants, mitigators and therapeutics for acute radiation
syndrome or the delayed effects of acute radiation exposure;
radionuclide-specific therapies, including chelating agents, blocking
agents, and other novel decorporation agents; improved methods of
radiation biodosimetry and bioassay for radionuclide contamination;
biomarkers of organ-specific radiation injury; therapeutics for
radiation combined injury; therapeutics for radiation-induced
immunosenescence.

Chief: Dr. Richard Hatchett

301-451-3109

Email: <hatchettr@niaid.nih.gov>

[]{#__RefHeading___Toc219687061 .anchor}Division of Microbiology and
Infectious Diseases

The Division of Microbiology and Infectious Diseases (DMID) supports
research to better understand, treat, and ultimately prevent infectious
diseases caused by virtually all infectious agents, except HIV. DMID
supports a broad spectrum of research from basic molecular structure,
microbial physiology and pathogenesis, to the development of new and
improved vaccines and therapeutics. 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 and emerging infectious disease
research.

Director: Dr. Carole Heilman

301-496-1884

Email: <ch25v@nih.gov>

A. ***[Bacteriology and Mycology Branch.]{.underline}*** Research areas:
(1) Products to address public health needs in medical bacteriology and
mycology including early stage development of vaccines/adjuvants (target
identification and characterization, device or apparatus development,
novel delivery, and preclinical evaluation), therapeutics (drugs and
novel antimicrobials interfering with host-pathogen interactions,
probiotics, immune modulators with broadly protective or
pathogen-specific potential, etc.), and multiplex medical diagnostics;
(2) Products to combat antibacterial and antifungal drug resistance; (3)
Application of proteomics and genomics technologies; (4) Host-pathogen
interactions; (5) Genetics, molecular, and cell biology; and (6)
Microbial structure and function. Research focused on the following
bacterial diseases is strongly encouraged: anthrax and other zoonotic
infections (plague, tularemia, glanders, melioidosis, brucellosis,
leptospirosis), Lyme disease, rickettsial and related diseases:
ehrlichiosis, anaplasmosis, bartonellosis, typhus, Q fever, tickborne
spotted fevers, actinomycete infections, sepsis, enterococcal
infections, staphylococcal infections, urinary tract infections,
nosocomial and other healthcare-associated infections, and vector-borne
bacterial infections. Research in the following areas is of particular
interest:

-   Vaccines, therapeutics, and medical diagnostics for glanders,
    melioidosis, typhus and Q fever

-   Vaccines and new therapeutics for common hospital-acquired
    infections, especially those with common resistance to existing
    antimicrobials

-   Novel approaches for the diagnosis of Lyme disease

Research focused on the following fungi and fungal diseases is strongly
encouraged: aspergillosis, blastomycosis, candidiasis,
coccidioidomycosis, cryptococcosis, histoplasmosis, Pneumocystis
carinii, and other primary and opportunistic fungal infections. 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}*** Special
emphasis areas include development of a single diagnostic tool for the
simultaneous identification of multiple diarrheal pathogens; pediatric
vaccines to prevent the major causes of worldwide diarrhea; more stable
vaccines and formulation improvements; vaccines against hepatitis C
virus; novel therapeutics for chronic hepatitis B and C; improved
therapies and vaccines for botulinum neurotoxins; and therapies and
diagnostics for *Clostridium difficile*.

Research areas of the Branch include the following organisms and
diseases: astrovirus, Bacteroides, Campylobacter, enteric Clostridia
including botulinum neurotoxin, commensals, Crohn\'s Disease, diarrhea,
enterotoxins, enteric *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, and
hepatitis viruses A, B, C, D, and E. Research studies encompass: (1)
basic virology and bacteriology, genome sequencing, natural history and
pathogenesis; (2) immunology of infectious diseases including mechanisms
of recovery and persistence, protective immune responses and
immunopathogenesis in humans and in animal models; (3) vaccine research
and development including novel approaches and delivery systems to
prevent infection as well as to control and treat disease; (4)
development and evaluation of adjuvants and vaccine vectors; (5)
identification of new therapeutic targets and development and evaluation
of therapeutics; (6) immunotherapy discovery and development; (7)
epidemiology, ecology, zoonoses, and transmission; (8) antimicrobial
resistance of these organisms in non-nosocomial settings; (9)
development of tools for rapid medical diagnosis of organisms, specific
targets, disease, and markers of disease outcome; (10) development of
model systems to study infection and disease and evaluate vaccines and
drugs; and (11) characterization and exploitation of the role of normal
flora in disease preventive therapy.

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) protozoan infections, including amebiasis,
cryptosporidiosis, cyclosporiasis, giardiasis, leishmaniasis, malaria,
trypanosomiasis, toxoplasmosis; helminth infections, including
cysticercosis, echinococcosis, lymphatic filariasis, schistosomiasis,
onchocerciasis, others (e.g., roundworms, tapeworms, and flukes);
invertebrate vectors/ectoparasites, black flies, sandflies, tsetse
flies, mosquitoes, ticks, snails, mites; (2) parasite biology (genetics,
genomics, physiology, molecular biology, and biochemistry); (3)
protective immunity, immunopathogenesis, evasion of host responses; (4)
clinical, epidemiologic, and natural history studies of parasitic
diseases; (5) research and development of vaccines, drugs,
immunotherapeutics, and medical diagnostics, and (6) vector biology and
management; 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: human
coronaviruses (including SARS), influenza viruses, and paramyxoviruses
(including parainfluenza viruses and respiratory syncytial virus); (2)
bacterial respiratory infections, 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, Klebsiella pneumoniae and community acquired pneumonia; (3)
acute otitis media; (4) mycobacterial diseases, including those caused
by: M. tuberculosis (tuberculosis), extensively- and multi-drug
resistant M. tuberculosis, M. leprae (leprosy), and M. ulcerans (Buruli
ulcer) and other non-tuberculous mycobacterial diseases. Areas of
emphasis include: development of new antibiotics with novel mechanisms
of action, improved therapeutics for viral and bacterial respiratory
diseases including immunotherapeutics, new or improved vaccines (with
and without adjuvants), improved and more rapid multi-plex point-of-care
diagnostic tests or other screening tools that can detect infection
prior to active disease and identify drug resistance.

Contact: Dr. Gail Jacobs

301-496-5305, Fax: 301-496-8030

Email: <gjacobs@niaid.nih.gov>

E. ***[Sexually Transmitted Infections Branch.]{.underline}*** Areas of
emphasis include the development of medical diagnostics including better
and more rapid multiplex point of care tests and other screening or
diagnostic tools, topical microbicides, vaccines and drugs 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}*** Areas of emphasis include: 1)
the emergence of viral diseases; 2) mechanisms of replication,
permissiveness, persistence, and latency; 3) vaccines; 4) immune
protection and evasion, and viral vectors; 5) epidemiology and viral
evolution; 6) structure and function of viruses and viral proteins; 7)
the development and validations of assays for disease diagnosis and to
measure response to therapy; 8) the development and preclinical testing
of immunotherapeutic and antiviral drugs for acute and chronic viral
illnesses; 9) molecularly targeted approaches to identify antiviral
targets and agents; 10) chemical design and synthesis of novel antiviral
agents; 11) preclinical antiviral evaluations including *in vitro*
screening and prophylactic or therapeutic antiviral evaluations of human
viral infections in animal models; 12) the development of rapid medical
diagnostic systems.

The Virology Branch focuses on the following: acute viral infections,
arthropod-borne and rodent-borne viral diseases (including dengue, West
Nile, Japanese encephalitis, Chikungunya, yellow fever, hantavirus,
etc.), viral hemorrhagic fevers (Ebola, Lassa fever, etc.), measles,
polio, coxsackie virus, enterovirus 71 and other enteroviruses,
poxviruses, rabies, and rubella. The Virology Branch also focuses on the
following persistent viral diseases and viruses: adenoviruses, BK virus,
bornaviruses, coronaviruses, herpesvirus, human T-lymphotrophic virus,
JC virus, human papillomaviruses, parvoviruses, and prion diseases.
Applications targeting the development of therapies, immunotherapies,
vaccines and diagnostics for any of these infections are sought. The
Virology Branch does not support applications covering environmental
detection and decontamination.

Chief: Denise Cinquegrana, MPH

301-451-3503, Fax: 301-402-0659

Email: <cinquegranad@niaid.nih.gov>

[]{#__RefHeading___Toc219687062 .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:

Mr. Michael Wright

Grants Management Specialist

National Institute of Allergy and Infectious Diseases

301-451-2688, Fax: 301-493-0597

Email: <mawright@mail.nih.gov>

[]{#__RefHeading___Toc219687063 .anchor}National Institute of Arthritis
and Musculoskeletal and Skin Diseases (NIAMS)

The mission of the National Institute of Arthritis and Musculoskeletal
and Skin Diseases is to support research into the causes, treatment, and
prevention of arthritis and musculoskeletal and skin diseases, the
training of basic and clinical scientists to carry out this research,
and the dissemination of information on research progress in these
diseases.

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___Toc219687064 .anchor}Arthritis and Musculoskeletal
and Skin Diseases

A. ***[Division of Skin and Rheumatic Diseases.]{.underline}*** This
division promotes and supports: basic and clinical studies of the skin
in normal and disease states; and research leading to prevention,
diagnosis and cure of rheumatic and related diseases. In the area of
Skin Diseases, the division has a wide range of skin diseases under
study with NIAMS support, to include 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. In the area of
Rheumatic Diseases, the division supports basic, epidemiologic, and
clinical research on etiology, pathogenesis, course, interventions, and
outcomes in rheumatic and related diseases.

This is not an inclusive list of all research topics covered by the
Division of Skin and Rheumatic Diseases. To learn more, please visit the
Division page at
<http://www.niams.nih.gov/Funding/Funding_Opportunities/Supported_Scientific_Areas/Skin_Rheumatic_Diseases/default.asp>.

B. ***[Division of Musculoskeletal Diseases.]{.underline}*** The
musculoskeletal system is comprised of the skeleton, which provides
mechanical support and determines shape; the muscles, which power
movement; and connective tissues such as tendon and ligament, which hold
the other components together. The cartilage surfaces of joints and the
intervertebral discs of the spine allow for movement and flexibility.

The Division of Musculoskeletal Diseases of the NIAMS supports research
aimed at improving the diagnosis, treatment, and prevention of diseases
and injuries of the musculoskeletal system and its component tissues.
Key public health problems addressed by this research include
osteoporosis, osteoarthritis, and muscular dystrophy. Research is
conducted at every level, from fundamental biology to clinical
intervention.

This is not an inclusive list of all research topics covered by the
Division of Musculoskeletal Diseases. To learn more, please visit the
Division page at
<http://www.niams.nih.gov/Funding/Funding_Opportunities/Supported_Scientific_Areas/Musculoskeletal_Diseases/default.asp>.

For general SBIR/STTR program information, contact:

Mr. Elijah Weisberg, NIAMS SBIR/STTR Coordinator

301-435-1002, Fax: 301-480-4543

Email: <weisberge@mail.nih.gov>

For administrative and business management questions, contact:

Ms. Sheila Simmons

301-594-9812, Fax: 301-480-5450

Email: <simmonss@mail.nih.gov>

Mr. Erik (Timothy) Edgerton

301-594-3968, Fax: 301-480-5450

Email: <edgertont@mail.nih.gov>

[]{#__RefHeading___Toc219687065 .anchor}National Institute of Biomedical
Imaging and Bioengineering (NIBIB)

The mission of the National Institute of Biomedical Imaging and
Bioengineering (NIBIB) is to improve health by leading the development
and accelerating the application of biomedical technologies. The
Institute is committed to integrating the physical and engineering
sciences with the life sciences to advance basic research and medical
care. This is achieved through: research and development of new
biomedical imaging and bioengineering techniques and devices to
fundamentally improve the detection, treatment, and prevention of
disease; enhancing existing imaging and bioengineering modalities;
supporting related research in the physical and mathematical sciences;
encouraging research and development in multidisciplinary areas;
supporting studies to assess the effectiveness and outcomes of new
biologics, materials, processes, devices, and procedures; developing
technologies for early disease detection and assessment of health
status; and developing advanced imaging and engineering techniques for
conducting biomedical research at multiple scales. More specifically,
the mission of the NIBIB includes the following research areas:

A. ***[Biomaterials.]{.underline}*** Development of new or novel
biomaterials that can be used for a broad spectrum of biomedical
applications such as implantable devices; drug and gene delivery; tissue
engineering; imaging agents; and biosensors and actuators. Research that
is supported includes the design, synthesis, characterization,
processing and manufacturing of these materials as well as the design
and development of devices constructed of these materials and their
clinical performance.

B. ***[Biomechanics and Rehabilitation Engineering.]{.underline}***
Research on biomechanics which can be applied to a broad range of
applications including implants, prosthetics, clinical gait and posture
biomechanics, traumatic injury, repair processes, rehabilitation, sports
and exercise, as well as technology development in other NIBIB interest
areas applied towards biomechanics. Rehabilitation engineering research
that is supported includes theoretical models and algorithms for
understanding neural, motor, and robotic control strategies;
quantitative analysis algorithms for predicting therapeutic outcomes;
and early stage development of neuroprosthesis technology, virtual
rehabilitation, and robotics rehabilitation.

C. ***[Biomedical Informatics.]{.underline}*** Development of new
technologies to collect, store, retrieve, and integrate quantitative
data; large-scale data-driven knowledge base and database methods that
support data mining, statistical analysis, systems biology and modeling
efforts; and improvement of computer science methods to protect
confidentiality of patient data.

D. ***[Drug and Gene Delivery Systems and Devices.]{.underline}***
Development of new and improved technologies for the controlled and
targeted release of therapeutic agents. Areas of emphasis include: the
development of new delivery vehicles such as nanoparticles and micellar
systems; energy-assisted delivery using ultrasound, electroporation,
etc.; and the integration of biosensing with controlled dosage delivery
using BioMEMS and other emerging technologies.

E. ***[Image-Guided Interventions.]{.underline}*** Research on use of
images for guidance, navigation and orientation in minimally invasive
procedures to reach specified targets. Examples include image-guided
interventions for minimally invasive therapies such as surgery and
radiation treatment, for biopsies, and for the delivery of drugs, genes
and therapeutic devices.

F. ***[Image Processing, Visual Perception, and Display.]{.underline}***
Study, invention, and implementation of structures and algorithms to
improve communication, understanding, and management of information
related to biomedical images. Research that is supported includes
software and hardware for image reconstruction, analysis, display and
perception, visualization, and computer-aided interpretation.

G. ***[Imaging Agents and Molecular Probes.]{.underline}*** Development
and application of novel imaging agents and probes for clinical or
pre-clinical applications. Examples of supported research include the
development and application of quantum dots, nanoparticles, nanoshells,
microbubbles, and radio-labelled contrast materials, and smart imaging
agents that are bio-activatible or activated by other chemical,
physical, or biological means.

H. ***[Magnetic, Biomagnetic and Bioelectric Devices.]{.underline}***
Development of magnetic, biomagnetic and bioelectric devices, e.g., EEG,
MEG, etc. Examples include (but are not restricted to) novel detectors,
increased sensitivity and spatial resolution, improved reconstruction
algorithms, multiplexing with other imaging techniques, etc.

I. ***[Magnetic Resonance Imaging and Spectroscopy.]{.underline}***
Development of MR imaging and MR spectroscopic imaging, for both animal
and human research, and potential clinical applications. Examples
include (but are not restricted to) fast imaging, high field imaging,
design of novel RF and gradient coils, novel pulse sequences, design of
novel contrast mechanisms, imaging informatics, in vivo EPR imaging,
molecular imaging, etc. The emphasis should be on technological
development rather than detailed applications to specific diseases or
organs.

J. ***[Mathematical Modeling, Simulation and Analysis.]{.underline}***
Development of mathematical models and computational algorithms with
potential clinical or biomedical applications, including multi-scale
modeling, modeling at or above the cellular level, and modeling at
subcellular level, including those developed to support technology
development in other program areas related to the NIBIB mission.
Research that is funded includes studies that focus on the development
of algorithms, mathematical models, simulations and analysis of complex
biological, physiological, and biomechanical systems and use genomics
and proteomics.

K. ***[Medical Devices and Implant Science.]{.underline}*** Design,
development, evaluation and validation of medical devices and implants.
This includes exploratory research on next generation concepts for
diagnostic and therapeutic devices; development of tools for assessing
host-implant interactions; studies to prevent adverse events;
development of predictive models and methods to assess the useful life
of devices; explant analysis; improved in vitro and animal models for
device testing and validation.

L. ***[Micro- and Nano-Systems, Platform Technologies.]{.underline}***
Development of BioMEMS, microfluidics and nanoscale technologies,
including micro-total analysis systems, arrays, and biochips, for
detection and quantitation of clinically relevant analytes in complex
matrices. Application areas include biomedical research, clinical
laboratory diagnostics, biodefense, high-throughput screening, drug
delivery, tissue engineering, and implantable devices, among others.

M. ***[Nanotechnology.]{.underline}*** Research and development of new
enabling technologies for the fabrication and use of nanoscale
components and systems in diagnostic and therapeutic applications.
Examples include: development of new nanoscale patterning and
manipulation systems; new approaches to the sensing and quantification
of biologically important molecules using nanoscale specific properties;
studies relating to the safety and commercialization of
nanotechnology-enabled biomedical products.

N. ***[Nuclear Medicine.]{.underline}*** Research and development of
technologies that create images out of the gamma-ray or positron (and
resulting photon) emissions from radioactive agents that are injected,
inhaled, or ingested into the body and then concentrate in specific
biological compartments. Two particularly active areas are the wedding
of positron emission tomography (PET) and single photon emission
computed tomography (SPECT) to CT and/or to MRI, and the design of
higher resolution, lower cost PET and SPECT devices for the study of
molecular probes in small animals. Other topics of interest include the
development of better radiopharmaceuticals, crystal scintillators, and
collimators, and novel approaches to dual-isotope imaging and to
dosimetry.

O. ***[Optical Imaging and Spectroscopy.]{.underline}*** Development and
application of optical imaging, microscopy, and spectroscopy techniques;
and development and application of optical imaging contrasts. Examples
of research areas include fluorescence imaging, bioluminescence imaging,
OCT, SHG, IR imaging, diffuse optical tomography, optical microscopy and
spectroscopy, confocal microscopy, multiphoton microscopy, flow
cytometry, development of innovative light sources and fiber optic
imaging devices.

P. ***[Sensors.]{.underline}*** Development of sensor technologies for
the detection and quantitation of clinically relevant analytes in
complex matrices. Application areas include (among others) biomedical
research, clinical laboratory diagnostics, and biodefense, covering in
vitro diagnostics, noninvasive monitoring, and implantable devices.
Technologies encompassed include novel signal transduction approaches,
materials for molecular recognition, biocompatibility, signal
processing, fabrication technologies, actuators, and power sources.

Q. ***[Structural Biology.]{.underline}*** Development of structural
biology techniques, including (but not restricted to) solid state NMR,
EPR, synchrotron radiation, etc. The emphasis is on technological
development, rather than applications to specific structural biology
problems.

R. ***[Surgical Tools and Techniques.]{.underline}*** Research and
development of new medical technologies to improve the outcomes of
surgical interventions. Examples of relevant technologies include:
minimally invasive surgeries, energy-based interventions such as RF
ablation, robotically assisted surgical systems, integration of imaging
and interventional modalities, image guided interventions and
telehealth.

S. ***[Telehealth.]{.underline}*** Development of software and hardware
for telehealth studies that have broad applications as well as early
stage development of telehealth technologies that may have specific
focus areas. Research that is supported includes methods to address
usability and implementation issues in remote settings, and methods to
develop technology for standardizing and incorporating state of the art
security protocols for verifying user identities and preserving patient
confidentiality across remote access.

T. ***[Tissue Engineering and Regenerative Medicine.]{.underline}***
Development of enabling technologies including real-time, non-invasive
tools for assessing the function of engineered tissues; real-time assays
that monitor the interaction of cells and their environment at the
molecular and organelle level; predictive computational models for
engineering function 3D tissues; high-throughput assays and instruments
to reduce the cost, time, and complexity of tissue engineering; novel
bioreactor techniques for expanding stem cells and growing tissues and
organs on a large scale; and strategies for preserving, sterilizing,
packaging, and transporting living-tissue products. The program also
supports applications of rational engineering design principles to
functional engineered tissues; the development of novel biomaterials for
use as tissue scaffolds that mimic the extracellular matrix and support
multiple cell types in defined spatial orientation; and engineering
approaches to study how biomaterials interact with cells and guide cell
growth, differentiation, and migration.

U. ***[Ultrasound.]{.underline}*** Improvement of technologies for
diagnostic, interventional and therapeutic uses of ultrasound. The
diagnostic ultrasound program includes, but is not limited to the
design, development and construction of transducers, transducer arrays,
and transducer materials, innovative image acquisition and display
methods, innovative signal processing methods and devices, and
optoacoustic and thermoacoustic technology. It also includes the
development of image-enhancement devices and methods, such as contrast
agents, image and data presentation and mapping methods, such as
functional imaging and image fusion. The interventional ultrasound
program includes the use of ultrasound for therapeutic use, or as an
adjunct for enhancement of non-ultrasound therapy applications. Examples
include, but are not limited to, high-intensity focused ultrasound
(HIFU) as a non-invasive or minimally invasive interventional surgical
or therapy tool, and as an adjunct interventional tool. It also includes
the use of ultrasound contrast agents for therapy and for targeted drug
delivery, and the use of ultrasound for image-guided surgery, biopsy,
and other interventions.

V. ***[X-ray, Electron, and Ion Beam.]{.underline}*** Enhancement of
computed tomography (CT), computed radiography (CR), digital radiography
(DR), digital fluoroscopy (DF), and related modalities. Research areas
of support include the development of: flat panel detector arrays and
other detector systems; flat-panel CT; CT reconstruction algorithms for
the cone-beam geometry of multi-slice CT; approaches to radiation dose
reduction, especially with CT; and novel x-ray applications, such as
those utilizing scattered radiation, tissue-induced x-ray phase shifts,
etc.

[]{#__RefHeading___Toc219687066 .anchor}Other Research Topic(s) Within
the Mission of the Institute

Areas of high programmatic interest include:

-   intelligent systems design and smart modeling

-   enabling nanotechnologies for designed drug and gene delivery
    vehicles

-   in vivo optical imaging

-   activatable imaging agents

-   multiscale modeling in biomedical systems

-   sensor and lab-on-a-chip devices for point-of-care testing

-   imaging informatics

-   development of engineered 3D human tissue model systems for drug
    discovery and development

-   image-guided interventions

-   in vivo microimaging of internal organs

-   techniques for characterization and modification of biomaterial
    interfacial properties

-   high-field and high speed (parallel) MRI

-   high-frequency and very high-frequency ultrasound imaging and other
    applications

-   novel sensing technologies

-   enabling technologies for tissue engineering and regenerative
    medicine

-   high-intensity focused ultrasound (HIFU) therapies or interventions

-   computational analysis and simulation methods

-   affordable medical technologies aimed at reducing disparities in
    healthcare

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___Toc219687067 .anchor}National Cancer Institute (NCI)

The goal of the NCI is to eliminate the suffering and death due to
cancer. The Small Business Innovation Research (SBIR) and Small Business
Technology Transfer (STTR) Programs are NCI\'s engine of innovation for
developing and commercializing novel technologies and products to
prevent, diagnose, and treat cancer. NCI's SBIR and STTR Programs offer
funding in **nanotechnology, anti-cancer agents, biomarkers, proteomics,
diagnostics, imaging technologies, pharmacodynamics,** and many more
areas of interest to the NCI.

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 SBIR
homepage: <http://sbir.cancer.gov/>. In addition, please see the contact
list at the end of the NCI section to identify the Program Director
within the NCI SBIR Development Center who specializes in your
technology area.**

[]{#__RefHeading___Toc219687068 .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.cancer.gov](http://crchd.cancer.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.

[]{#__RefHeading___Toc219687069 .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
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; and serves as the focal point for the Federal
Government on the synthesis of epidemiological and experimental data
concerning biological agents relating to cancer. 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\. Generation of new inbred genetic animal models that transmit
defective or altered cancer-related genes.

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

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

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

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

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

12\. Development of new or improved methods to isolate intact cellular
regulatory complexes for functional studies.

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

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 for functional studies.

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 transformation, 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 alteration in the 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 molecular biology reasons
underlying the 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 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 and dendritic cells.

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.

13\. Development and integration of nanotechnology and microfluidics in
the analysis of DNA and chromosomal aberrations and the identification,
mapping, and cloning of cancer susceptibility and resistance genes.

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

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

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, bioinformatics,
systems biology and integrative biology 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, improved, or high throughput technologies for
whole genome scanning for gene identification.

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

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

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

5\. Rapid methods to isolate intact complexes of regulatory proteins and
to separate and identify the proteins for biophysical studies.

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

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

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

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

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

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

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

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

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

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

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

17\. Application and development of novel approaches for in vivo and in
vitro modifications of protein expression in cells and tissues, e.g.
RNAi, microRNA, other small molecules.

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

19\. 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.

20\. Technology and software for elucidating molecular interactions and
networks.

21\. Develop new, improved or high-throughput technologies for analyzing
epigenomic changes.

22\. Improved software for the integration of heterogeneous data
sources.

23\. Development of new, improved or high-throughput technologies for
understanding the cancer metabolome.

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___Toc219687070 .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:**

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-   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.

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-   **Tools for cancer epidemiology studies:**

```{=html}
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```
-   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.

-   MicroRNA Profiling in Epidemiologic studies.

-   Detection of mitochondrial DNA alterations for Cancer Epidemiologic
    studies.

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}*** Over the past few decades, advances in
technology have played a key role in enhancing the quality of cancer
care through improvements in the prevention, diagnosis, and treatment of
cancer. A driving force fostering the utilization of media technology to
develop cancer communication products and their dissemination is NCI's
Multimedia Technology and Health Communication SBIR/STTR Program. The
Program serves as an 'engine of innovation' translating cancer research
into commercially viable products for primary care professionals,
researchers, patients and their families, and the general public.

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 and that are
updated during the fiscal year. This site also provides important
program requirements and other SBIR information.

[]{#__RefHeading___Toc219687071 .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___Toc219687072 .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, infectious agents, and 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://www.cancer.gov/prevention/index.html>.

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 animal 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 the development of:

a\) Animal models, including transgenic and knockout, to examine the
cancer prevention effects of bioactive food components.

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 on cancer related
processes; i.e., cell division, apoptosis, immunity, angiogenesis.

e\) Educational interactive software packages that focus on dietary
exposures and cancer prevention.

f\) Effective methods for assessing the content of bioactive food
components in foods and dietary supplements.

g\) Bioengineering tools for the study of bioenergetics and obesity.

h\) New and/or improved diagnostic markers for assessing the nutritional
status of individuals prior to developing a neoplasm.

i\) Technologies for detecting and identifying carcinogenic and cancer
protective compounds in foods.

j\) Surrogate cells for predicting the response to bioactive food
components in target tissue(s).

k\) Methods for the isolation and preparation or synthesis of candidate
nutrients in quantities suitable for preclinical and clinical screening.

l\) Blends/combinations of bioactive food components for cancer
prevention.

m\) Novel technologies for assessing the effects of dietary components
on the extracellular matrix and tissue microenvironment.

n\) Methodologies to understand stem and progenitor cells with the
microenvironment as determined by dietary components.

o\) Approaches for identifying responders from non-responders of dietary
prevention intervention strategies.

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___Toc219687073 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Mr. Michael Weingarten

Director, NCI SBIR Development Center

National Cancer Institute

Bldg. 31/10A19

31 Center Drive MSC 2580

Bethesda, MD 20891

\(301\) 496-1550

Email: <weingartenm@mail.nih.gov>

Website: [http://sbir.cancer.gov](http://sbir.cancer.gov/)

Dr. Ali Andalibi

Program Director and Team Leader

Small Business Innovation Research Development Center (SBIR)

National Cancer Institute

Bldg. 31/10A19

31 Center Drive MSC 2580

Bethesda, MD 20891

Email:andalibia@mail.nih.gov

**Area of expertise: Biologics, Small Molecules and Therapeutic Surgical
Interventions**

Dr. Gregory Evans

Program Director and Team Leader

Small Business Innovation Research Development Center SBIR)

National Cancer Institute

Bldg. 31/10A19

31 Center Drive MSC 2580

Bethesda, MD 20891

Email: <evansgl@mail.nih.gov>

**Area of expertise: Cancer Biology, E-Health and Epidemiology,**

Dr. Andrew Kurtz

Program Director

Small Business Innovation Research Development Center (SBIR)

National Cancer Institute

Bldg. 31/10A19

31 Center Drive MSC 2580

Bethesda, MD 20891

Email: <kurtza@mail.nih.gov>

**Area of expertise: Biologics, Small Molecules, and Nanotherapeutics**

Mr. David Beylin

Program Director

Small Business Innovation Research Development Center (SBIR)

National Cancer Institute

Bldg. 31/10A19

31 Center Drive MSC 2580

Bethesda, MD 20891

Email: <beylind@mail.nig.gov>

**Area of expertise: Cancer Imaging, Radiation Therapy and Image Guided
Interventions**

Dr. Patricia Weber

Program Director

Small Business Innovation Research Development Center (SBIR)

National Cancer Institute

Bldg. 31/10A19

31 Center Drive MSC 2580

Bethesda, MD 20891

Email: <weberpa@mail.nih.gov>

**Area of expertise: E-Health, Epidemiology, Software Development
related to Cancer Control & Population Sciences, and Biologics**

Dr. Natalia Kruchinin

Program Director

Small Business Innovation Research Development Center (SBIR)

National Cancer Institute

Bldg. 31/10A19

31 Center Drive MSC 2580

Bethesda, MD 20891

Email: <kruchininn@mail,nih.gov>

**Area of expertise: In-Vitro Diagnostics and Cancer Prevention**

Dr. Xing-Jian Lou

Program Director

Small Business Innovation Research Development Center (SBIR)

National Cancer Institute

Bldg. 31/10A19

31 Center Drive MSC 2580

Bethesda, MD 20891

Email: <loux@mail.nih.gov>

**Area of expertise: In-Vitro Diagnostics and Bioinformatics**

For administrative and grants management questions, contact:

Ms. Rosemary Ward

Grants Management Specialist

MSC 7150

6120 Executive Blvd

Rockville, MD 20892-7150

\(301\) 496-3182 Fax: 301-496-8662

Email: <wardros@mail.nih.gov>

For NCI-related SBIR Information, visit:
<http://www3.cancer.gov/admin/gab/index.htm>.

[]{#__RefHeading___Toc219687074 .anchor}*eunice kennedy shriver*
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___Toc219687075 .anchor}Phase II Competing Renewal
Awards

NICHD will accept Phase II SBIR 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 NICHD SBIR
Phase I or Phase II support and who are currently Phase II awardees are
eligible. Budgets for Phase II renewals should not exceed 3 million
dollars total costs for three years. Depending on the research proposed
the amounts may vary each year for the time requested.

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-09-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.

*Eunice Kennedy Shriver* National Institute of Child Health and Human
Development

301-402-4221, Fax: 301-402-0832

Email: <lq2n@mail.nih.gov>

[]{#__RefHeading___Toc219687076 .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:

-   Development of reagents to facilitate study of reproductive and
    developmental processes.

-   Development of improved methods of growing and differentiating stem
    cell lines in vitro, including feeder cell-free approaches.

-   Development of novel assays, kits, and devices to monitor fertility
    and treat infertility and gynecological disorders.

-   Use of genomics and proteomics to develop novel diagnostics and
    treatments for reproductive diseases and disorders.

-   Development of high resolution technologies to provide invasive or
    noninvasive assessments of reproductive and developmental
    competence.

-   Development of experimental animal models that would be useful for
    studying the physiology and pathophysiology of reproductive
    processes.

-   Development of improved and novel technologies for the preservation
    of human gametes.

-   Development of improved technologies for preimplantation genetic
    diagnosis.

-   Development of improved technologies for the reprogramming of cells,
    including embryonic stem cells or adult cells, into eggs and sperm.

Dr. Richard J. Tasca

301-435-6973, Fax: 301-496-0962

Email: <rt34g@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:

-   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.

-   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.

-   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 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.

-   Studies relating contraception or reproductive health to STDs such
    as HIV, including but not limited to development of new
    contraceptive products with microbicidal activity against STDs such
    as HIV; studies to define the relationships among contraceptive
    methods and HIV acquisition, transmission, or disease progression;
    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@mail.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:

-   Technological innovations/inventions to help collect biomarker data,
    especially technologies that can be used in large surveys.

-   Creation of hardware/software to aide in the collection of accurate
    cause of death/health diagnosis for the purposes of statistical
    analysis in population based datasets.

-   Innovative use/implementation in integrating geographical
    information systems, spatial network analysis, and/or simulation
    methods for demographic research.

-   Innovative approaches to analyzing and disseminating large-scale
    data sets.

-   Development of effective tools for prevention research and
    intervention programs related to STD/HIV, pregnancy, divorce, child
    health, at risk youth, and other health-related topics.

-   Innovative approaches to teaching population studies and other
    behavioral and social sciences at the undergraduate and graduate
    level.

-   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. Michael L. Spittel

301-435-6983, Fax: 301-496-0962

Email: <spittelm@mail.nih.gov>

[]{#__RefHeading___Toc219687077 .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 programs
on psychological, social and emotional, psychobiological, and
educational development from conception to maturity, specifically:

-   Social and Affective Development, Child Maltreatment and Violence,
    including normative social, affective, and personality development
    and the impact of the physical and social environments on health and
    psychological development; investigations of socio-cultural,
    familial, individual, and biological influences on development; and
    child developmental processes in high-risk settings (e.g., in
    violent or abusive environments, or families experiencing stressors
    such as poverty, unemployment or parental depression).

-   Developmental Cognitive Psychology, Behavioral Neuroscience, and
    Psychobiology, including linkages among developing brain, behavior,
    and genes; developmental pathways leading to normal and atypical
    brain development and behaviors and their underlying developmental
    mechanisms at the molecular, genetic, cellular and network levels;
    biological and behavioral indices of individual differences
    predictive of development at different points of development;
    neuroanatomical, neurofunctional, electrophysiological and
    neurochemical correlates of sensorimotor and cognitive abilities;
    tools to measure these; the effect of hormonal influences on
    behavioral development, including the development of gender-specific
    behaviors, the role of endocrines in social, emotional, and
    cognitive development, and the interaction of hormones and
    stress-related behaviors during development.

-   Risk Prevention and Health Promotion: behavioral and developmental
    aspects of health risk behaviors and health promotion from infancy
    to young adulthood, including individual, interpersonal, and social
    factors; environmental and contextual factors; and interactions of
    genes and environment as they relate to health and health behaviors.
    Issues of risk behaviors, health literacy, adherence, pain, obesity,
    influence of electronic media, and influences of religiosity and
    spirituality are of interest.

-   Reading, Writing, and Related Learning Disabilities: relative
    contributions of environmental, experiential, instructional,
    cognitive, linguistic, genetic, and neurobiological factors to the
    developmental reading process and to reading disabilities and
    writing, including the longitudinal course of development and the
    interactions among these factors at different stages of reading
    development, in both mono- and bilingual individuals.

-   Language and Bilingualism: language development and disorders and
    second language acquisition, including studies within a
    developmental context, that identify and explicate the cognitive,
    linguistic, social, cultural, socioenvironmental, geographic,
    environmental, instructional, and neurobiological factors affecting
    the development of language abilities.

-   Early Learning and School Readiness: experiences children need from
    birth to age eight to prepare them to learn, read, and succeed in
    school; early interactions with adults and peers; early childhood
    education teaching methods and curricula; comprehensive early
    childhood interventions that support learning and development.

-   Math and Science Cognition, Learning and Learning Disabilities:
    mathematical thinking and problem solving; scientific reasoning,
    learning, and discovery; studies that explore the genetic and
    neurobiological substrates of normal and atypical development in
    mathematics and science learning and cognition, as well as
    cognitive, linguistic, sociocultural, and instructional factors;
    individual differences that may moderate achievement; the
    delineation of skill sets needed to attain proficiency; development
    of effective instructional methods for typical development and
    interventions for learning disabilities.

Dr. Peggy McCardle

301-435-6863, Fax: 301-480-7773

Email: <pm43q@mail.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@mail.nih.gov>

C. ***[Pediatric, Adolescent, and Maternal AIDS.]{.underline}***

Domestic and international research on human immunodeficiency virus
(HIV)/acquired immune deficiency syndrome (AIDS) in women of
child-bearing age, pregnant women, mothers, fetuses, infants, children
and adolescents. Specific areas of interest include but are not limited
to epidemiology, clinical manifestations, pathogenesis, transmission,
treatment and prevention of HIV infection, including prevention of
mother to child transmission, and HIV-related complications in these
populations. Additional areas of interest include:

-   New technologies relevant to resource-limited countries for:

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-   diagnosis of HIV infection in infants;

-   diagnosis and treatment of HIV-related complications of HIV (e.g.,
    diagnosis of tuberculosis in children);

-   simple and less technical assays to monitor CD4 cell
    percentage/count, HIV viral load, or other surrogate markers of
    disease progression in children.

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-   Drug formulations for antiretroviral drugs and/or drugs used to
    treat complications of HIV infection relevant to children
    (preferably not liquid preparations), particularly in
    resource-limited countries and including fixed dose drug
    formulations and innovative methodologies for development of solid
    formulations capable of being administered to young children (e.g.,
    sustained release beads, etc).

-   Simple, standardized tools to evaluate neurodevelopmental outcome in
    children in resource-limited settings.

-   Topical microbicide agents to prevent sexual acquisition of HIV in
    women or in adolescents.

-   New, non-invasive technologies to evaluate complications of
    antiretroviral drugs in HIV-infected infants, children, adolescents
    (e.g., mitochondrial toxicity) and pregnant women, their fetuses and
    children.

Dr. Kevin Ryan

301-435-6871, Fax: 301-496-8678

Email: <KRyan@mail.nih.gov>

[]{#__RefHeading___Toc219687078 .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}*** The topic areas of
research include 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.

The following topic areas are of high priority:

-   Non-invasive methods for assessing cardiovascular and pulmonary
    functions, including cardiac output, systemic blood pressure, airway
    resistance, pulmonary compliance, vital capacity and various lung
    volumes.

-   Metabolic profile assessment using non-invasive or minimally
    invasive approaches. Particular area of expertise include
    measurement of glucose and lactate/pyruvate; assessing ketone body
    measurements; free indirect bilirubin (uncongjugated, free
    indirect); major chemicals (Na^+^ Ca^+^ Cl^+^ K^+^ etc.) in the
    blood.

-   Improved point of care methods to measure plasma glucose
    concentrations quickly and accurately.

-   Devices, instruments, and tools to minimize bacterial colonization,
    reduce proclivity for thrombous formation; reduce health-care
    associated infection risks.

-   Rapid methods for diagnosis of bacterial infections and
    inflammation.

-   Non-invasive measures to assess brain energy utilization, especially
    glucose, oxygen, lactate, ketones, and other energy substrates.

-   Innovative ideas to reduce stress for the staff, parents and infants
    in the NICU.

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 aberrant embryonic and fetal development and including early
embryogenesis, limb formation, development of the nervous system,
developmental immunology, and causative factors in teratogenesis.
Applications to develop and apply new animal model systems; innovative
and high throughput genomic and proteomic technologies and systems
biology approaches to advance the study of embryonic development and
structural birth defects; imaging of developmental processes and gene
expression; and, newborn screening for primary immunodeficiencies are
particularly welcome.

Dr. Lorette Javois

301-496-5541, Fax: 301-480-0303

Email: <lj89j@mail.nih.gov>

C. ***[Mental Retardation and Developmental
Disabilities.]{.underline}*** Biomedical, behavioral and biobehavioral
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
environmental factors (e.g., social, economic and cultural) that
influence the occurrence of mental retardation and developmental
disabilities (MRDD); and research leading to the, prevention,
amelioration and assessment of MRDD, particularly through expanded
newborn screening and prenatal diagnosis.

Dr. Mary Lou Oster-Granite

301-496-1383, Fax: 301-496-3791

Email: <mo96o@mail.nih.gov>

[]{#__RefHeading___Toc219687079 .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>.
Examples may include:

-   Enabling technologies for restoration of function.

-   Promoting behavioral adaptation to functional losses.

-   Assessing the efficacy and outcomes of medical rehabilitation
    therapies and practices.

-   Developing improved assistive technology.

-   Promoting rehabilitative outcomes in pediatric critical care.

-   Understanding whole body system responses to physical impairments
    and functional changes.

-   Developing more precise methods to measure impairments,
    disabilities, and societal limitations.

-   Training health professionals in the field of medical
    rehabilitation.

-   Development of Home Centered Rehabilitation care systems.

-   Promoting profession structured/directed self care and wellness.

-   Development of tools to assist and facilitate families in their
    involvement in rehabilitation.

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

Louis A. Quatrano, Ph.D.

301-402-4221, Fax: 301-402-0832

Email: <lq2n@mail.nih.gov>

[]{#__RefHeading___Toc219687080 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Louis A. Quatrano, Ph.D.

*Eunice Kennedy Shriver* National Institute of Child Health and Human
Development

301-402-4221, Fax: 301-402-0832

Email: <lq2n@mail.nih.gov>

For administrative and business management questions, contact:

Mr. Ted Williams

Grants Management Specialist

*Eunice Kennedy Shriver* National Institute of Child Health and Human
Development

301-435-6996, Fax: 301-451-5510

Email: <williate@mail.nih.gov>

[]{#__RefHeading___Toc219687081 .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___Toc219687082 .anchor}Phase II Competing Renewal
Awards

(See <http://grants.nih.gov/grants/guide/pa-files/PA-06-036.html>.)

NIDA will accept competing renewal Phase II SBIR/STTR grant applications
from Phase II SBIR/STTR awardees 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 strongly encouraged to contact NIH staff
prior to submission of a type 2 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-09-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/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 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___Toc219687083 .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 both in adult and developing organisms. 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
also 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. The focus of maternal and paternal drug
use is to ascertain the consequences of drug exposure on brain
development as well as on other physiological systems.

Computational and theoretical modeling of biological systems and
behavioral processes, biomedical computing and/or information science
and technology development is supported by DBNBR.

1\. *[Metabolomics in Drug Abuse Research.]{.underline}* Metabolomics is
the study of all 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
programs.

NIDA is looking for proposals on development of novel metabolomics
technologies toward practical application in pathway and network
investigation in biological systems particularly in understanding the
mechanisms of drug addiction and discovering biomarkers for developing
treatment for drug addiction.

Phase I proposal should demonstrate the feasibility of developing new
metabolomics technology and phase II should focus on the application of
this technology in drug abuse research.

Hari H. Singh, Ph.D.

301-443-1887

E-mail: <hs87j@nih.gov>

2\. *[Development of Alternate Drug Delivery Dosage Forms for Drugs
Abuse Studies.]{.underline}* The SBIR proposals are being solicited to
design and develop alternate dosage forms for drugs that are not orally
administered such as nicotine, marijuana, heroin, etc. Phase I should
demonstrate the feasibility of the proposed innovation and Phase II, the
development and testing of the innovation.

Hari H. Singh, Ph.D.

301-443-1887

E-mail: <hs87j@nih.gov>

3\. *[Discovery of New Chemical Probes.]{.underline}* The SBIR proposal
are being solicited to discover new chemical compounds as biological
probes either by synthesis or isolation from natural resources in
studying the mechanisms of action of drugs of abuse. Such substances
could be new chemical compounds, drug products, or peptides. Currently
there are several ligands available through the NIDA drug supply system
such as SR 141716A, SR144528, CP 55,840, anandamide, epibatidine,
mecamylamine, SNC 80, NCS-382, U50,488H, DALDA, DSLET, Dynorphins,
DALCE, Orphanin FQ, Kaffiralin 1 and 2, etc. All probes for
cannabinoids, neuropeptides, nicotinic acetylcholinergic receptors and
related probes for drug abuse study are encouraged. In addition
proposals on biological screening of such new compounds as potential
ligands for drug abuse research will also be considered.

Phase I should demonstrate the feasibility of the proposed innovation
and Phase II, the development, characterization, testing, and screening
of innovation. It should also be demonstrated that the new or modified
chemical compounds are suitable for drug abuse research.

Rao S. Rapaka, Ph.D.

301-443-1887

Email: <rr82u@nih.gov>

4\. *[Discovery and Study of Psychoactive Components of
Botanicals.]{.underline}* NIDA is looking for proposals to develop
methods for the isolation, purification, identification and
characterization of active and inactive ingredients of herbal plants
(stimulants, hallucinogenic, analgesics, and/or narcotics) and
evaluation of their biological properties. Such studies may include
chemistry, toxicology, pharmacodynamics, pharmacokinetics and the
mechanisms of action of active and inactive ingredients to understand
their efficacy, usefulness, adverse effects and abuse potential.

Phase I should demonstrate the feasibility of the proposed innovation
and Phase II, the development, characterization, testing, and screening
of innovation.

Rao S. Rapaka, Ph.D.

301-443-1887

Email: <rr82u@nih.gov>

5\. *[Virtual Reality for Treatment of Pain.]{.underline}* 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.

David Thomas, Ph.D.

301-435-1313

Email: <dt78k@nih.gov>

6\. *[Virtual Reality for the Treatment of Drug Abuse.]{.underline}*
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)
is 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.

301-435-1313

Email: <dt78k@nih.gov>

7\. *[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.

301-435-1313

Email: <dt78k@nih.gov>

8\. *[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.

301-435-1314

Email: <ta17r@nih.gov>

9\. *[Functional Genomics Resources and Strategies:]{.underline}* In the
post-genomic era, an explosion of gene discovery studies utilizing
strategies such as genome-wide association scans, microarrays, and
proteomics have identified a host of genes/gene variants associated with
susceptibility to, or protection from, diseases of addiction. A critical
next step is to validate these candidate genes/variants to determine
which ones play an authentic functional role in mediating addiction.
Functional validation could occur at many different phenotypic levels
ranging from the molecular to the behavioral. Studies could investigate
a few high priority genes/variants or could test several hundred
genes/variants rapidly. The development of resources and strategies that
would facilitate functional validation of genes/gene variants could
include (but are not limited to) the following areas:

a\. Gene/variant effects on subcellular localization, stability, or
function of mRNAs/proteins relevant to drug addiction.

b\. The development of imaging and other strategies to identify
gene/variant effects on neuronal or brain functions relevant to
addiction.

c\. Strategies to identify gene/variant effects on behavior, such as
response to addictive stimuli, stress, or changes in social situations.

d\. RNA interference-mediated depletion of candidate genes in cells or
whole organisms to look for phenotypic alterations such as changes in
synapse, dendritic spine, or cell morphology, gene expression, or
behavioral responses to drugs of abuse.

e\. Strategies exploiting the growing collection of genetic mutants in
candidate genes (particularly utilizing model organisms such as mouse,
zebrafish, *Drosophila*, *C. elegans* or yeast) to functionally validate
genes/variants.

f\. Approaches enabling comparison of wild type protein function to the
function of allelic variants using *in vivo* transgenes or *in vitro*
biochemical assays, especially if these approaches reveal whether a
variation increases or decreases gene function.

g\. Systems-based approaches investigating whether a set of candidate
genes is co-expressed in a particular brain region or cell type,
physically interacts with one another, or functions together in a signal
transduction cascade are also of great interest.

h\. Approaches to ascribe drug abuse-related function to genes/variants
in non-coding RNAs, microRNAs, gene regulatory elements, gene copy
number, or other putative non-protein coding regions of the genome.

i\. Methods of translating functional studies in model systems to
validate gene/variant function in humans.

John Satterlee, Ph. D.

(301)-435-1020

Email: <satterleej@nida.nih.gov>

10\. *[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.

301-443-1887

Email: <jp183r@nih.gov>

11\. *[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.

301-443-1887

Email: <jp183r@nih.gov>

12\. *[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.

301-443-1887

Email: <jp183r@nih.gov>

13\. *[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, which 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, treatment and study of substance abuse as well as the
evaluation of prevention and treatment strategies.

Karen Skinner, Ph.D.

301-435-0886

Email: <Ks79x@nih.gov>

[]{#__RefHeading___Toc219687084 .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 effect drug
related cognition, emotion, motivation and behaviors.

2\. Decomposition of prevention programs, practices and strategies 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\. State-of-the-art and practical strategies for the integration of
evidence-based prevention approaches into existing prevention 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 practical and affordable community tools for: needs
and resource assessment, selection of appropriate evidence-based
programs and strategies, high-quality implementation of identified
programs and strategies, evaluation at community, organization and
individual levels, and sustainability.

11\. Drug abuse prevention methodological research on promising data
collection, data storage, data dissemination, and reporting techniques.

12\. Marketing evidence-based prevention interventions for substance
abuse and related HIV prevention.

13\. Studies applying technologies and strategies that have been
developed for use in other disciplines in order to examine the utility
of their application for drug abuse prevention, such as virtual reality
technologies being used for some clinical conditions (e.g. phobias,
eating disorders), and serious video games are being used for some
clinical conditions (e.g., cancer patients), but not for drug abuse
prevention.

14\. Development and testing of innovative drug abuse prevention
intervention products, using discoveries from the basic biological (e.g.
neurobiological), psychological (e.g. emotional, behavioral, cognitive,
and developmental) and social (e.g. social learning, peer network, and
communications) sciences.

15\. Development and testing of adaptations for efficacious prevention
research approaches to make these more appropriate for special
populations including racial and ethnic minorities, non-English speaking
populations, immigrant populations, rural and migrant populations, low
literacy populations, or persons with disabilities.

16\. Development of methods, state-of-the-art tools and systems for
community coalition-building.

17\. Tools to measure intervention costs, cost effectiveness, and net
economic benefits.

18\. Development and testing of rapid assessment tools of sexual and
drug use risk behaviors for use in health care and public health
environments, including STI clinics and AIDS research centers.

Augie Diana, Ph.D.

301-443-1942

Email: <dianaa@nida.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.* 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.* 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.* 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.

3\. *[Development of State-of-the-Art Mechanisms for Epidemiological
Research.]{.underline}* The development of state-of-the-art mechanisms
to facilitate the use of Geographical Information Systems (GIS) in
community epidemiology studies (for example Community Epidemiology Work
Groups) and other drug abuse research is if great interest. There is a
need for enhanced software and hardware for GIS interfaces, database
management, visualization, and innovative spatial analysis capabilities.
The role of GIS in public health management and practice continues to
evolve. Application of this technology is an important step towards
better understanding drug abuse issues and their inherent complexities.
The ability to evaluate geospatial information provides a unique
perspective of public health issues such as emerging and shifting
epidemics, the utilization of treatment services, and rapid assessment
of the impact of incidents ranging from natural disasters to
bioterrorism. When used alongside more traditional epidemiological
techniques, GIS provides epidemiologists the ability to address new
questions, refine, or enhance existing analyses.

Bethany Deeds, Ph.D.

301-402-1935

Email: <deedsb@mail.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 ongoing systems. In research settings, such an initiative
is vital for the assessment of new technologies developed for transfer
to practice.

2\. *[Determining the Costs of Implementing Evidence-Based Practices
(EBPs) and Other Technologies in Drug Abuse Treatment.]{.underline}*
Research shows that new technologies or evidence-based practices (EBPs)
can improve drug treatment outcomes, and it has been asserted that
large-scale drug abuse treatment improvement requires systematic
implementation of proven practices, processes, and technologies. Often,
however, new drug treatment approaches are not adopted or sustained in
usual practice, even in programs that served as settings for research
showing their effectiveness. This may be due in part to a poor
understanding of the initial or ongoing costs entailed by new practices,
processes, or technologies (hereafter referred to as technologies).
Methods and tools need to be developed and tested to help drug abuse
treatment service providers and payers arrive at realistic estimates of
the costs of implementing and sustaining new technologies in usual
practice settings. With regard to new technologies, implementing is
defined as an ongoing process of selecting, adopting, and adapting these
new technologies into ongoing treatment, particularly with consideration
for the local setting, population and available resources. Sustaining is
defined as an ongoing process of providing needed resources (such as
staffing, training, and equipment), maintaining the quality of the new
technology through evaluation, monitoring, and improvement, and
determining its ongoing utility compared to alternatives. The tools and
methodologies should be able to identify and estimate costs separately
for implementing and for sustaining new technologies, and should
consider both clinical and administrative technology. At a minimum,
domains in which costs should be estimated include assessment of
programmatic need, appropriateness, and value; staffing qualifications
(salary and competencies); training, support, equipment, and other
infrastructure requirements; information / data requirements; quality
monitoring and improvement; and evaluation of outcomes.

Sarah Duffy, Ph.D.

301-443-6504

Email: <sduffy@nida.nih.gov>

3\. *[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.

4\. *[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.

5\. *[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.

6\. *[Assessment Tools for Quantifying and Organizational Culture that
Promotes and Sustains a Drug-Free Workforce.]{.underline}* Though
drug-free workplace programs are ubiquitous in large businesses, small
businesses often lack the staff and resources to create effective
drug-free programs because they may involve in-house or contract experts
to educate, train, monitor, and enforce policies and practices that will
sustain a healthy workforce and a safe and healthy workplace. Though
there are numerous model drug-free workplace policies and programs
provided free by federal, state, and local governments as well as
nongovernmental organizations, many fail to provide management with
affordable or free, easy-to-use tools to assess the baseline of their
organizations' culture for drug abuse intolerance, and to monitor
progress in building a drug-free organizational culture. Research shows
that individual employees and organizations vary in their support for a
drug-free workplace. Surveys indicate that coworker tolerance for
illicit drug use varies by the type of drug, the type of industry, and
the work role of the respondents. A drug-free culture creates
commonly-held attitudes, beliefs and practices among employees that are
socially reinforced. Once established, the need for costly external
incentives and other measures abates as coworkers socialize new
incumbents and enforce behavior promoting abstinence. Tools and
methodologies need to be developed to a) assess an organization's
baseline culture for drug abuse intolerance both on and off the job, b)
identify policies and practices that undermine a drug-free culture, c)
enable the identification of programs, policies, and practices capable
of helping the workforce develop/strengthen an organizational culture of
intolerance for drug use, and d) estimate the impact on the
organization's quality of work-life, job safety, individual and group
performance and productivity, and the profitability of the organization
itself. Included would be inexpensive and easy to use tools for
monitoring workforce behavior change, and changes in the impact on the
organization (as outlined in "d").

Thomas F. Hilton, Ph.D.

301-443-6504

Email: <Tom.Hilton@nih.gov>

7\. *[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.

8\. *[New Technologies for Screening, Assessing, and Preventing Problem
Drug Use and HIV, Matching Patients with Appropriate Treatment
Services.]{.underline}* Increased understanding of the complexities of
problem drug use and HIV risk behaviors 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 HIV, 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, including HIV, (b) assess
the nature and degree of drug use and HIV risk behaviors, (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, HIV risk behaviors and infection, and
associated health problems in a variety of health care settings,
speeding the assessment and treatment process, and improving treatment
placement decisions.

Dionne Jones, Ph.D.

301-443-6504

Email: <djones@nida.nih.gov>

9\. *[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.

Akiva Liberman, Ph.D.

301-402-0807

Email: <libermanA@nida.nih.gov>

10\. *[Technologies to Support Quality Improvement in Addiction
Treatment Systems.]{.underline}* New technologies to support quality
improvement in community-based, addiction treatment provider systems are
needed. Quality improvement methods, although well established in
business and healthcare management, are underutilized in addiction
treatment. Addiction treatment systems have limited resources for
initiating, developing, implementing, and sustaining quality improvement
practices. Most community-based provider systems have limited capacity
to capture and integrate information about (a) the nature and extent of
community needs and resources; (b) organizational and management
processes to facilitate adoption, adaptation, implementation, and
sustained use of science-based innovations; (c) implementation costs for
new service innovations; (d) client satisfaction; and (e) quality of
care. Centralized, automated and cost-efficient technological tools for
these purposes could help provider systems improve the quality and
efficiency of their treatment services, meet accreditation requirements,
and reduce operating costs.

Bennett Fletcher, Ph.D.

301-443-6504

Email: <bfletche@nida.nih.gov>

11\. *[Electronic Drug Abuse Treatment Referral Systems for
Physicians.]{.underline}* Research shows that primary care physicians
often do not screen for drug abuse disorders. While this may be related
to stigma attached to illicit drug use or to a lack of adequate health
insurance, it may also be due to the lack of an adequate referral system
that primary care physicians can use for the patients they identify as
having a potential drug problem. The lack of a referral system places a
greater burden on the physician to secure treatment resources for the
patient, and also places the physician at greater risk if no appropriate
treatment can be found. A practical and usable electronic drug abuse
treatment referral system needs to be developed and tested for use by
physicians in primary care settings, including doctor's offices. To be
effective and useful, the system needs to be targeted at local needs,
for example by taking into account local private insurance coverage and
the types of insurance accepted by local treatment providers. It should
also include an actively-maintained database of local providers, with
information on insurance carrier, geographic "catchment" area of
treatment providers, types of substance disorders treated, types of
co-occurring disorders (mental disorders, etc.) treated, gender, age,
other pertinent treatment factors needed by primary care physicians to
make appropriate referrals. The system should be designed to be reliable
and efficient, allowing for appointment scheduling or other needed
arrangements to ensure a successful referral. Feasibility and
cost-efficiency should be carefully considered.

Richard Denisco, M.D.

301-443-6504

Email: <deniscor@nida.nih.gov>

[]{#__RefHeading___Toc219687085 .anchor}Center for the Clinical Trials
Network

The mission of the Clinical Trials Network (CTN) is to improve the
quality of drug abuse treatment throughout the country using science as
the vehicle. The CTN provides an enterprise in which the National
Institute on Drug Abuse, treatment researchers, and community-based
service providers cooperatively develop, validate, refine, and deliver
new treatment options to patients in community-level clinical practice.
This unique partnership between community treatment providers and
academic research leaders aims to achieve the following objectives:

-   Conducting studies of behavioral, pharmacological, and integrated
    behavioral and pharmacological treatment interventions of
    therapeutic effect in rigorous, multi-site clinical trials to
    determine effectiveness across a broad range of community-based
    treatment settings and diversified patient populations; and

-   Ensuring the transfer of research results to physicians, clinicians,
    providers, and patients.

Materials and processes that facilitate clinical trials in community
practice settings are particularly needed in this program. Areas of
research include but are not limited to:

-   Projects that would simplify, automate, standardize, or reduce the
    cost of administration of clinical research instruments used in CTN
    trials

-   Projects that would reduce error rates in completing assessment or
    clinical instruments and in transmitting data to data management
    entities

-   Projects to develop instruments that measure factors relevant and
    important to the conduct of addictions research, such as: the extent
    of craving and/or of withdrawal, the risk of addiction to a
    particular substance, the therapeutic alliance between patient and
    therapist, perceived satisfaction with health care, probabilities of
    a pain management patient developing dependence/abuse on pain
    medications, and probability of successfully completing
    detoxification

-   Projects to develop instruments that measure and predict HIV risk
    behaviors

-   Projects that develop and evaluate innovative diagnostic drug
    screening tests for drug abuse, such as oral swabs

-   Projects that develop and evaluate the use of gene chip technology
    for drug abuse risk factors

Specific projects could include:

1\. *[Development of Innovative Techniques/Tools for the Screening,
Recruitment, and Follow-up of Participants in Drug Abuse
Trials.]{.underline}* Screening and recruitment of participants for
multi-center clinical trials pose a number of problems. Tracking
devices/programs are needed to document and manage a patient's
interaction throughout a clinical trial. This would include screening
tools, recruitment strategies that could be followed, and steps to
increase and document follow-up practices. Validated materials/tools
applicable to diverse populations for use in education and counseling of
potential participants are needed. These tools would be applicable
across trials and would provide a strategy for management to improve
clinical trial performance. These recruitment concerns are particularly
relevant for community practices, which often do not have the resources
of larger hospitals or academic institutions. Both the participants and
the research clinicians administering the trial would benefit from this
product. Approaches are needed to develop innovative techniques and/or
tools for the screening, recruitment and follow-up of clinical trial
participants in drug abuse trials. These tools or techniques can be from
the standpoint of clinicians who are running the clinical trials, to
patients who are participants in the drug abuse trials. Tools can
include software for following up on participants, reminder tools for
clinical trial participants, technological devices for clinician or
patient use. The ultimate goal is to make the trial management more
efficient and effective.

Carmen Rosa, M.S.

301-443-9830

Email: <crosa@nida.nih.gov>

2\. *[Development of Practical Training Materials for Evidence-Based
Treatment.]{.underline}* States have initiated the requirement that
community treatment programs provide evidence-based treatment or risk
losing their public funding if they don't comply. The onus is on the
publicly funded program to provide their staff with training in
evidence-based treatment modalities. Current staff training
opportunities in evidence-based treatments are expensive and frequently
require repetition because of high rates of staff turnover. The level of
staff training and education varies across agencies. Certification in
evidence-based treatment has not been standardized. Externally presented
training is not timely or efficient. Computers with Internet
capabilities are not always available for staff learning opportunities.
It is important to offer alternatives to the delivery of training that
are easy for staff to access and that meet requirements to provide
evidence-based treatment. There is a need for practical, non-computer
and interactive, self-administered computer versions for training
counseling staff in evidence-based drug abuse treatments. Such programs
should include competency testing to meet local and state requirements
for certification, such as, motivational incentives, motivational
interviewing, cognitive-behavior therapy, and other proved therapies.

Quandra Scudder

301-443-6697

Email: <qs3y@nih.gov>

3\. *[Development of Drug Use Bracelet.]{.underline}* It is difficult to
accurately track a patient's drug use when they are outpatients in a
program or study. Relying on a weekly or monthly urine test is not
always reliable. History indicates that patients are more likely to
abstain from illegal drug use when their behavior is observed. This
initiative is for the development of a cost effective and tamper proof
bracelet to detect drug use that can be worn by patients. The bracelet
should be one that can be worn for 1-2 weeks. After it is worn for a
length of time, the patient would come into the clinic, and the bracelet
would be removed for analysis for drug use. The bracelet should contain
chemical profiles for at least 4 major categories of illicit drugs and
be easily worn for up to a month and non-irritating to the skin.

Quandra Scudder

301-443-6697

Email: <qs3y@nih.gov>

4\. *[Development of eHealth Tools.]{.underline}* eHealth, the
healthcare practice supported by electronic processes and communication,
offers the potential to increase quality, enhance reach, lower cost,
resolve time/distance concerns, and customize patient care. Information
technology can be implemented to support a broad array of applications.
We are looking for novel, unique, state-of-the-art eHealth tools
(software and hardware) that can be implemented to promote the efficacy
and safety of clinical trials in the area of substance abuse (e.g., the
development of a tool that could be used to change behavior and reduce
the drug addiction). Security and privacy should be considered in the
application of these tools to protect patients.

Quandra Scudder

301-443-6697

Email: <qs3y@nih.gov>

5\. *[Development of Instruments To Assess Co-morbidities.]{.underline}*
Drug and alcohol treatment centers lack a brief assessment instrument to
screen their patients for mental health disorders. There are diagnostic
instruments available; however, they require specialized training and
can be time consuming to administer. For this reason and others,
co-morbid conditions such as depression, ADHD or PTSD often go
undiagnosed and untreated in this population. If clinicians had a proper
instrument to screen these patients, they could then refer them for
further evaluation. This initiative is for the development and
validation of an instrument to be used in community practices to screen
for mental health disorders when patients present themselves for drug
and/or alcohol treatment. The instrument should be easy to use either by
the clinician (as an interview) or by the patient (as a self assessment)
and could be either in paper format or computerized.

Carmen Rosa, M.S.

301-443-9830

Email: <crosa@nida.nih.gov>

6\. *[Development of Practical Training Programs for Addressing Learning
Disabilities in Drug Abusers in Treatment.]{.underline}* *Development of
Practical Training Programs for Addressing Learning Disabilities in Drug
Abusers in Treatment.* Compared to the general population, individuals
in drug abuse treatment are much more likely to have a learning
disability. Because many commonly employed drug abuse treatment
approaches are dependent on patients/clients' ability to understand and
apply new information, even relatively minor learning impairments may
limit the potential benefits of these interventions and adversely affect
drug abusers' treatment outcomes. For an individual patient/client's
treatment regimen to have an optimal chance of success, it should be
tailored to address any co-occurring disorders, including learning
disabilities that may be present. There is a need for training programs
that provide clinicians with guidance and practical tools for shaping
their treatment approaches in response to learning disabled drug
abusers' individual needs. These programs may incorporate training
regarding screening for and assessment of learning disabilities and/or
provide links to appropriate resources that address these topics.
Developers should also consider utilizing user-friendly and engaging
training strategies (e.g., web-based training, interactive learning,
case studies) where appropriate.

David Liu, M.D.

301-443-9802

Email: <dliu@nida.nih.gov>

7\. *[New Technologies: Integrating data from Prescription Monitoring
Program(s) to Current Clinical Practice.]{.underline}* In some states
the prescription monitoring program collects prescription data for
controlled substances into a central database which can then be used by
limited authorized users to assist in deterring the illegitimate use of
prescription drugs. Only those persons authorized by law can be provided
information from the database. Prescribers and dispensers in some states
may query the database to assist in determining treatment history and to
rule out the possibility that a patient is \"doctor shopping\" or
\"scamming\" in order to obtain controlled substances. In that case, a
prescriber must obtain written consent from the patient before
submitting an inquiry. However, limited time/resources of busy medical
offices might be barrier of obtaining and utilizing this information to
improve quality of treatment each individual patient. This initiative
will support development and testing the effectiveness of new
technologies that facilitate utilization of data collected by
Prescription Monitoring Program(s) in clinical practice. Applications
may include, but are not limited to, the development and testing of new
and innovative Internet-based systems that provide a) practitioners with
current information of their patients treatment/medication compliance b)
transfers data automatically to patients chart, etc. The goal is to
minimize barriers of clinical staff to obtain, record and utilize the
data while maintaining strict security requirements (i.e.,
confidentiality, integrity, and availability). These new technologies
should provide a more cost effective way of identifying treatment
non-compliance and help adjust the treatment plan according to the needs
of individual patient as well as decrease potential diversion of
controlled substances.

Petra Jacobs, M.D.

301-496-8974

Email: <pj104@nih.gov>

[]{#__RefHeading___Toc219687086 .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.

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 or cannabinoid abuse.

4\. Development of heroin/morphine-protein conjugates (heroin/morphine
conjugate vaccines) for the treatment of heroin/opiate addiction.

Richard Kline, Ph.D.

301-443-8293

Email: <rk108@nih.gov>

5\. Development of new approaches for the administration of potential
addiction treatment drugs (including small molecules, natural products,
peptides, proteins, antibodies, etc.) with poor bioavailability.

6\. 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.

7\. Development of novel dosage forms or chemical/pharmaceutical
approaches that eliminate or significantly reduce the abuse potential of
prescription drugs/drug products.

8\. Development of novel technologies and strategies to deliver
potential therapeutic agents (including small molecules and peptides)
across blood brain barrier for the treatment of drug addiction.

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 areas:

-   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.]{.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 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.

4\. *[Development of Software for Data Management of Medical Safety Data
from Clinical Trials.]{.underline}* Recent policies for the protection
of human subjects participating in clinical trials are requiring
increasing levels of medical safety monitoring. Currently, adverse event
and serious adverse event data management (collection, storing,
analysis, and reporting) is heterogeneous. Different investigators use
different nomenclatures, definitions, timeframes, data collection
instruments, and data analysis and reporting methods. This heterogeneous
and often inadequate data system limits the interpretation of safety
results and the ability to make sound decisions about the safety (and
often the efficacy) of clinical trials. In some instances, external
reviewers may misinterpret the reported signs or symptoms and may
provide wrong recommendations. Furthermore, inadequate safety data does
not allow comparing the adverse events and serious adverse events
results across multiple clinical trials, which hinders the scientific
progress, and increases costs. The purpose of this initiative is to
stimulate research on innovative medical safety data management tools
for clinical trials testing interventions for drug addiction, while
guaranteeing the privacy and confidentiality of study participants.
Appropriate management of medical safety data will enhance the
protection of human subjects, optimize the reviews by IRBs, DSMBs,
funding and regulatory agencies, promote the trust of participants and
the community in clinical trials, enhance scientific progress, and lower
research costs.

Ivan D. Montoya, Ph.D.

301-443-8639

Email: <imontoya@mail.nih.gov>

5\. *[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.

Steve Oversby, Psy.D.

301-435-0762

Email: <soversby@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___Toc219687087 .anchor}Division of Clinical
Neuroscience and Behavioral Research (DCNBR)

A. ***[Behavioral and Integrative Treatment Branch.]{.underline}*** The
Behavioral and Integrative Treatment Branch is interested in research on
behavioral and integrative treatments for drug abuse and addiction. The
term \"behavioral treatments\" is used in a broad sense and includes
various forms of psychotherapy, behavior therapy, cognitive therapy,
family therapy, couples and marital therapy, group therapy, skills
training, meditation, guided imagery, counseling, and rehabilitative
therapies. The term, "Integrative treatments" refers to treatments that
combine behavioral interventions with other treatments, including other
behavioral therapies, medications, and/or complementary/alternative
therapies. Behavioral and integrative treatment research has been
conceptualized to consist of three stages. Stage I, or early treatment
development, involves research on the development, refinement, and pilot
testing of behavioral and integrative interventions. Stage I may include
translational research that incorporates concepts, methods or findings
from other disciplines (e.g., neuroscience, cognitive science, etc.)
into the development of behavioral and integrative treatments. Stage I
may also include research to develop or adapt treatments to become more
"community-friendly." Stage II includes testing treatments that show
promise and testing the "dose-response" of treatments. Stage III is
research aimed at determining if and how efficacious behavioral
treatments may be transported to community settings. Stage III may
include studies that test treatments in community settings, with
community therapists. Stage III may also include studies that develop or
test methods of training treatment providers to administer treatments.
Determination of mechanism of action of treatment is relevant to all
three stages. Specific areas of interest include:

1\. *[Translation from Basic Behavioral or Cognitive
Science.]{.underline}* "Stage I" research on the development 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, Affective and Social Neuroscience
Findings Towards Development of Behavioral Treatments.]{.underline}*
"Stage I" research on the development of behavioral treatments or
components of such therapies that are based on developments and findings
from cognitive, affective, or social neuroscience.

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, alone or in combination with behavioral
interventions, for use in conjunction with drug abuse treatment, as a
means of improving treatment for drug abuse is needed. Developmentally
and age appropriate, as well as gender sensitive 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 treatments 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
and juvenile justice system. Examples of possible studies are those that
are designed to reduce the cost 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\. *[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. There is a need for research related to the development
and testing of new and improved behavioral interventions(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, including HIV positive drug abusers with
comorbid medical illnesses and/or psychiatric disorders. There is also a
need to develop and test adherence interventions 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>

6\. *[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.

7\. *[Integration of Behavioral Treatments and
Pharmacotherapies]{.underline}*. Development of integrated behavioral
treatments 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 treatments 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 treatments could possibly enhance compliance with medication
regimens, *[increase]{.underline}* retention allowing pharmacological
effects to occur and prevent relapse to drug abuse and addiction.

8\. *[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.

9\. *[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.

10\. *[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.

11\. *[Developing, Evaluating, and Transporting Culturally Sensitive
Behavioral Treatments 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.

12\. *[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, inhalants, and prescription opioids and psychostimulants, as
well drug abusers with comorbid psychiatric disorders and/or medical
illnesses such as HIV/AIDS, hepatitis, etc.

13\. *[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.

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 has 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.

18 *[Youth Smoking Cessation.]{.underline}* Smoking related illnesses
usually occur in adults. However, tobacco use and nicotine addiction
generally begin in childhood or adolescence. Despite health warnings,
adolescents continue to initiate smoking at alarming rates and the
majority will continue to smoke as adults. Adolescents who begin to
smoke, develop nicotine dependence very quickly and exhibit withdrawal
symptoms during quit attempts in a similar fashion to adults. Most
adolescents who smoke, express a desire to quite. To date, research on
smoking cessation for teen smokers has not been particularly fruitful.
More research is needed to develop interventions for young smokers. This
initiative requests research aimed at the development and testing of
smoking cessation treatments tailored to the specific needs of
adolescents. Consideration should also be given to gender and ethnicity.

Debra Grossman, M.A.

301-443-0107

Email: <dg79a@nih.gov>

19\. *[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.

20\. *[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.

21\. *[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.

22\. *[Complementary and Alternative Medicine Therapies (CAM) for Drug
Abuse Treatment]{.underline}*. Research is encouraged on complementary
and alternative interventions for drug abuse treatment. CAM
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 CAM 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.

23\. *[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.

24\. *[Behavioral Treatments for Pre-Adolescents and
Adolescents.]{.underline}* Behavioral treatments 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.

25\. *[Behavioral Treatments 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.

26\. *[Behavioral Treatments 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 reports suggesting possible contraindications of group
treatments for some populations (e.g., delinquent adolescents), or in
some formats (e.g., less-structured, client-led groups).

27\. *[Behavioral Treatments 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.

28\. *[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.

Lisa Onken, Ph.D.

301-443-0107, Fax: 301-443-6814

Email: <l010n@nih.gov>

29\. *[Transporting Behavioral Treatments to Community
Practitioners]{.underline}*. There is a need for effective methods of
transferring behavioral treatments 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 and Integrative Treatment 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.

30\. *[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.

31\. *[Virtual Reality Applications for Drug Abuse]{.underline}*.
Development and improvement of treatments using Virtual Reality and
other new technologies is 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.

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.

Cecelia Spitznas, 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.

Steven Grant, Ph.D.

301-443-4877

Email: <sgrant@nida.nih.gov>

3\. *[Development of Interactive Computer Applications for
Neuropsychological/ Neurocognitive Assessment to Determine Functional
Brain Deficits in Acute and Chronic Drug Abusers.]{.underline}*
Development of a neurobehavioral test battery to assess alternations in
neurobehavioral/ neurocognitive function or emotional reactivity
resulting from drug abuse/addiction is encouraged. Of particular
interest is the development of assessments that can be administered via
a web interface for use over the internet or for administration in
neuroimaging studies. Also of great interest is assessments that be used
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.). Care should be taken not to duplicate or overlap with other NIH
supported assessment tools currently in development (e.g., NIH Toolbox,
MATRICS, EXAMINER, CENTRICs).

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.

Steven Grant, Ph.D.

301-443-4877

Email: <sgrant@nida.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 lose 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.

Steven Grant, Ph.D.

301-443-4877

Email: <sgrant@nida.nih.gov>

7\. *[Development of Field-Deployable Tools for Quantifying Exposures to
Psychosocial Stress and to Addictive Substances.]{.underline}* This
announcement encourages the development, improvement and/or adaptation
of measurement technologies for the purpose of creating field-deployable
tools that can detect and quantify personal exposure to psychosocial
stress and/or addictive substances with maximum precision and
reliability. Ideally, the technology could be applied in large-scale
population studies to comprehensively measure multiple addictive
substances and psychosocial stress events, either singly or jointly.
Comprehensive assessment includes measuring acute/chronic/cumulative
exposures to psychosocial stress and/or addictive substances with a high
degree of temporal and spatial resolution (i.e., as a person moves
through environments), and with a high degree of accuracy and
sensitivity to detect meaningful variations in extent of and response to
exposure across developmental periods (ranging from prenatal to
senescence) and among various population groups.

Harold Gordon, Ph.D.

301-443-4877

Email: <hr23r@nih.gov>

8\. *[Development of Sustainable Repositories for Cognitive/Behavioral
and Brain Measures Related to Substance Abuse.]{.underline}* Secondary
data analysis is becoming an increasing important manner to leverage the
usefulness of costly clinical neuroscience studies. One barrier to
secondary data analysis is the lack of robust repositories capable of
collecting and indexing the wide variety of complex experimental designs
and large amounts of data collected in brain imaging and other clinical
neuroscience studies. A second barrier is sustaining the repository over
long periods of time. Applications are sought that will provide means to
overcome one or more of these barriers.

Steven Grant, Ph.D.

301-443-4877

Email: <sgrant@nida.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.

Larry Stanford, Ph.D.

301-402-3869

Email: <ls187n@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.

Larry Stanford, Ph.D.

301-402-3869

Email: <ls187n@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.

301-402-3869

Email: <ls187n@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___Toc219687088 .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, health care
providers, and others. These might include but are not limited to:

-   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.

-   Development of methodology to transfer new knowledge and directions
    of scientific growth to teachers, curriculum developers and health
    care providers.

-   Development of computer based learning systems that allow students
    to experience the scientific process.

-   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.

-   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___Toc219687089 .anchor}International Program

NIDA's International Program takes advantage of unique opportunities
outside the U.S. to develop new knowledge on the causes, consequences,
prevention and treatment of drug abuse and addiction and to develop and
strengthen capacity and dissemination of science base information to
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\. Development of a mechanism to enhance international drug abuse
researchers' ability to conduct secondary data analyses. While the
strategies to address the international phenomenon of drug addiction
need to be empirically driven, there are limited funds to support
original international drug abuse research which subsequently increases
the importance of secondary analyses of existing data sources
particularly in low- and middle-income countries. The mechanism to
expand the use of existing data sources that can inform policy is likely
be multifaceted and may include: identification of existing data
sources, provision of training in secondary data analyses, and
interpretation of data analyses for making policy-based decisions. The
focus of the research can address any component of drug use, abuse and
addiction that is within NIDA's research portfolio.

2\. Development of computer and web-based tools to facilitate research,
data analysis and network building. Such activities will improve and
increase the amount and quality of international research and advance
scientific knowledge on addiction.

3\. Development of standardized behavioral, physiological, and/or
toxicological measures of drug use and drug impairment for use in
international comparative studies of drugged driving.

Steve Gust, Ph.D.

301-443-6480

Email: <sgust@nida.nih.gov>

[]{#__RefHeading___Toc219687090 .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, M.B.A.

Grants Management Specialist

Grants Management Branch

National Institute on Drug Abuse

6101 Executive Boulevard,

Room 270, MSC 8403

Bethesda, Maryland 20892-8403

301-443-6710, Fax: 301-594-6849

Email: <dhaikali@ngmsmtp.nida.nih.gov>

[]{#__RefHeading___Toc219687091 .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___Toc219687092 .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 Roger Miller, Ph.D., (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-09-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___Toc219687093 .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 new or better
materials for earmolds to address allergy, occlusion effect and/or
feedback complaints; development of new or improved batteries for
hearing aids and or cochlear implants, including solar rechargeable
devices; 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, including
tinnitus; 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.

Roger Miller, Ph.D.

National Institute on Deafness and Other Communication Disorders

301-402-3458, Fax: 301-402-6251

Email: <millerr@nidcd.nih.gov>

[]{#__RefHeading___Toc219687094 .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___Toc219687095 .anchor}Voice, Speech, and Language
Programs

Research on voice, speech, and language disorders focuses on determining
the nature, causes, treatment and prevention of communication 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;
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 speech impairment, including a
brain computer interface (BCI) communication prosthesis; development of
innovative treatment delivery systems or intervention protocols; design
and development of diagnostic measures or materials for early
identification of voice, speech and language impairment in children;
development of assessments and treatments for childhood and adult voice,
speech and 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 voice, 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___Toc219687096 .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___Toc219687097 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Roger Miller, Ph.D.

National Institute on Deafness and Other Communication Disorders

301-402-3458, Fax: 301-402-6251

Email: <millerr@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___Toc219687098 .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/).

NIDCR's small business programs are highly focused on maximizing
translational opportunities -- moving rapidly and intentionally toward
pushing innovation in basic orofacial biology into useful products. The
following are areas of particular interest.

[]{#__RefHeading___Toc219687099 .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. Small
business opportunities in this area might include:

A. Develop early pregnancy genetic tests to screen fetal cells in
maternal blood for genetic mutations involved in inherited syndrome and
non-syndrome craniofacial defects.

B. Develop instrumentation to improve the diagnosis and treatment of
inherited and acquired craniofacial defects.

C. Develop improved appliances to aid suckling by newborn infants with
cleft palate and cleft lip.

[]{#__RefHeading___Toc219687100 .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. Specific examples of technology development needs include:

A. 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.

B. 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.

C. 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).

D. Develop controlled release systems for local delivery of synthetic
peptides, recombinant proteins, or other therapeutic agents to prevent
and/or control oral infectious diseases, or the oral manifestations of
HIV infection.

E. 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.

F. Develop ways to interfere with microbial colonization and growth
through the use of antimicrobial agents and chemotherapy.

G. Identify and exploit the structural features of oral biofilms for
increased therapeutics delivery.

H. Develop computer programs to model biologically active peptide
regions of oral components that have anti-fungal, anti-bacterial and
anti-viral activities. Challenges appropriate for small business
proposals could include:

I. Develop substitutes of naturally occurring chemicals (phytochemicals)
known to have a role in controlling opportunistic infections induced by
HIV.

J. Develop synthetic peptides and recombinant proteins of oral
components with anti-fungal, anti-bacterial and anti-viral, specifically
HIV, activities.

[]{#__RefHeading___Toc219687101 .anchor}Epithelial Cell Regulation and
Transformation

Emphasis is on the molecular mechanisms of oral epithelial cell
regulation and aberrations of these mechanisms. Research related to
early diagnosis, prevention, and treatment of oral neoplasias is
particularly relevant for the NIDCR small business program. Some
examples include but are not limited to the following areas:

A. Develop imaging techniques for the early detection, diagnosis and
prognosis of pre-malignant head and neck lesions including oral
carcinomas.

B. 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.

C. Develop novel techniques for the evaluation of chromosomal changes in
head and neck cancers.

D. Develop effective pharmacological, immunological and radiological
modalities for treatment of pre-malignant and malignant head and neck
lesions.

E. Develop novel technologies for the genetic and molecular-targeted
therapy of head and neck carcinomas.

F. Develop novel micro and nano-sensor technologies that can release
therapeutic agents in tumor cells.

G. Develop regimens for the alleviation of the oral complications of
cancer therapy.

H. Develop novel technologies for using stem cells as therapeutics for
head and neck cancers.

[]{#__RefHeading___Toc219687102 .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.
Such technologies that could speed translational research might include:

A. Develop standardized, high-sensitivity, high-accuracy 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 novel methods and instrumentation to detect and/or treat the
earliest signs of demineralized enamel that may develop into carious
lesions.

D. Develop systems that effectively remove or neutralize dental caries
using non-mechanical means to minimize iatrogenic pulp death.

E. Develop non-invasive devices to assess pulpal health prior to and
during treatment; develop means to neutralize necrotic pulps
non-mechanically to reduce or eliminate the need for root canal therapy.

F. Develop novel methods and agents to promote scarless repair of cleft
lip and scarless cutaneous healing following craniofacial surgery.

G. Develop viral and non-viral vectors for salivary gene therapy and
gene therapeutics.

H. Develop non-invasive methods for the determination of efficacy and
safety of artificial saliva, sialogogues and of their delivery vehicles
used in addressing the diminution or lack of saliva (xerostomia) due to
Sjögren's syndrome or head and neck irradiation cancer therapy.

I. Develop apparatus for craniofacial bone distraction that is contained
entirely within the oral cavity for use in the restoration of large bony
defects and/or building bone for orthodontic procedures.

J. Develop more efficient methods, materials, and devices for prevention
of injuries to the teeth, mouth, and face during athletic activities.

K. Develop genetic standards, databases, and diagnostics to predict oral
responses to drugs used for the treatment of craniofacial, oral and
dental diseases.

L. Develop standardized methodologies for the detection of fluoride load
in the body from saliva, serum, urine, nail clippings, and hair.

[]{#__RefHeading___Toc219687103 .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.
NIDCR encourages small business proposals specifically to:

A. Develop improved techniques for measuring nociceptive, 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. Discover and develop non-narcotic medications with particular
emphasis on chronic orofacial pain disorders.

[]{#__RefHeading___Toc219687104 .anchor}Biotechnology and Biomaterials

Emphasis is on the development of novel biomaterials and technologies
for promoting repair, regeneration, restoration and reconstruction of
diseased and injured oral and craniofacial tissues. This includes
development of natural and synthetic biomaterials for dental repair and
for manufacturing of tissue replacement constructs, quantitative methods
for evaluating the quality and performance of biomaterials and tissue
constructs, as well as their interactions with the host tissues.
Specific examples of relevant small business proposals could include:

A. Develop technologies for design and fabrication of biocompatible
biomaterials and tissue constructs to be used for reconstruction and
regeneration of oral and craniofacial tissues.

B. Develop non-destructive in vitro and in vivo methods for imaging of
cells, tissue constructs and biomaterials.

C. Develop synthetic analogues of oral and craniofacial tissues and
organs for use in high throughput biological assays of tissue function
and physiology.

D. Develop sensitive methods for measuring and quantification of
biomaterial-tissue biocompatibility and biotoxicity.

E. Develop mathematical and computer algorithms for modeling oral and
craniofacial tissue function and physiology.

F. Develop technologies for ensuring sterility of biomaterials and
tissue engineered constructs prior to implantation.

G. Develop efficient and non-immunogenic viral and non-viral gene
delivery systems to oral and craniofacial tissues.

H. Develop nanotechnology-based implantable biomaterials for dental,
oral and craniofacial tissue restoration.

I. Develop improved surgical techniques for replacement of dental, oral
and craniofacial tissues and organs.

J. Develop safe and effective technologies for the diagnosis and
treatment of temporomandibular joint disorders (TMJDs).

K. Develop safe and effective biomaterials and construct fabrication
technologies for repairing TMJDs.

L. Develop improved composite biomaterials and adhesive sealants
suitable for restoring crowns of posterior teeth and exposed roots of
teeth.

M. Develop new effective orthodontic and other prosthetic appliances and
constructs.

N. Develop approaches for generating complex tissue/organ structures,
such as teeth, periodontal ligament, TMJ, and vascularized and
innervated bone and muscle.

O. Develop methods for standardization and comparison of different stem
and progenitor cell populations for use in dental and craniofacial
tissue engineering.

P. Develop methods for targeted delivery and release of therapeutic
biomolecules to oral and craniofacial tissues.

[]{#__RefHeading___Toc219687105 .anchor}Clinical and Behavioral Research

Provides support for the development of evidence-based products related
to behavioral and social aspects of oral health, oral health prevention
or treatment interventions, and other patient-oriented aspects of oral
health. This includes support for clinical trials and patient-oriented
research to establish safety and initial efficacy of products. NIDCR is
especially interested in applications that significantly improve oral
health by: 1) being broadly applicable to many populations, 2)
contributing to meaningful oral health improvements for a specific
population, 3) expediting translation of research findings into oral
health improvements, and/or 4) equipping oral health care providers,
educators or researchers with tools to improve public oral health.
Examples of studies of interest include, but are not limited to, the
following:

A. 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 in a variety of settings, including
naturalistic settings, within clinical trials, within oral health care
delivery systems, etc.

B. Develop and test novel compliance and survey measures or tools to
identify the underlying causes of insufficient preventive dentistry for
specific underserved populations.

C. Develop, or adapt for use in a new population or setting, novel
measures or methods for identifying individual, family, group, or other
processes that explain oral health behavior.

D. Develop and test for safety, efficacy, and/or effectiveness of
measures or materials for diagnosing, preventing, or treating oral,
dental, and craniofacial conditions and disorders.

E. Develop, or adapt for use in a new population or setting, oral health
interventions utilizing technology to improve efficiency of delivery
(e.g., management of chronic pain related to temporomandibular joint
disorders, etc.).

F. Develop, or adapt for use in a new population or setting,
interventions addressing health behaviors highly associated with oral
health (e.g., tobacco, alcohol, and other drug use; management of
diabetes, HIV infection, or other chronic illnesses; etc.).

G. Develop technologies or modules that utilize existing web-based
platforms to improve preventive oral health hygiene for children and
adolescents (e.g., social marketing via web-based interaction, virtual
reality "worlds", "massively multiplayer online games", etc.).

H. Develop and test innovative methods for facilitating collaborations,
referrals, and/or ongoing follow-ups between oral health professionals
and other health care professionals.

I. Develop and test web-based training or other innovative approaches
for oral health care professionals to accelerate accurate translation of
new knowledge regarding oral diseases and their effective prevention or
treatment into clinical or public health practice.

J. Develop and test the effectiveness of innovative teaching tools to
inform oral health professionals or the public regarding oral cancer
prevention and early detection.

[]{#__RefHeading___Toc219687106 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

R. Dwayne Lunsford, Ph.D.

Coordinator, SBIR/STTR Program

Director, Microbiology Program

Integrative Biology and Infectious Disease Branch

Division of Extramural Research

National Institute of Dental and Craniofacial Research-NIH

Building 45, Room 4An18A

Bethesda, MD 20892-6402

301-594-2421, Fax: 301-480-8319

Email: <lunsfordr@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___Toc219687107 .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___Toc219687108 .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. These awards
are intended to support completion of research needed to obtain an IND
or IDE. Applicants must provide evidence that they have consulted
formally with the FDA concerning the research needed for the development
of a drug, biologic or medical device and that the proposed research
will address these regulatory requirements. Such evidence should include
FDA correspondence from a pre-IND meeting for an IND application or a
pre-IDE meeting for an IDE application, and the status of the 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-09-XXX)

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.

-   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.

-   Clinical and toxicology studies in support of an Investigational New
    Drug Application to the FDA.

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

[]{#__RefHeading___Toc219687109 .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. NIDDK will give priority
to research that has already progressed to an in vivo model or to be
clinically tested.

B. Integration of glucose sensor and insulin delivery systems to create
an artificial pancreas.

C. Development of improved insulin delivery methods or devices.

D. Incorporation of patient or provider tailored feedback, through human
factor and/or behavioral research, to improve glucose control.

II\. Screening Tests, Diagnostics and Biologic Tools:

A. Development of techniques or products useful for predicting,
preventing or delaying progression of diabetes, including tests for
identifying patients at risk, and methods of monitoring disease
progression.

B. Development of diagnostic tools for diabetic foot ulcers. These tests
could be used to determine the risk of developing a diabetic foot ulcer
or used for choosing treatment strategies.

C. Development of diagnostic tools to measure the autonomic neuropathy
that develops in people with diabetes.

D. Development of clinical measures of oxidative stress, advanced
glycation end-products and chronic inflammation that result from
diabetes.

E. 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.

F. Development and validation of surrogate markers to monitor disease
progression and potential therapies for diabetic complications.

G. Development of 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.

H. Development and validation of tools for use by health care
providers/systems to improve diabetes care and prevention.

I. 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.

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 or devices to prevent and treat diabetic
foot ulcers.

C. Development of new therapies to correct the underlying metabolic
defects that result from diabetes, such as reactive oxygen species
production and glycation of proteins.

D. 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.

E. 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.

F. Development of methods utilizing replenishable cell sources,
especially stem cells that produce functional islet like cells/tissues
that can be successfully transplanted.

G. 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.

H. Development of educational or psychosocial approaches that increase
adherence to recommended diabetes treatment regimens or that reduce
co-morbidities and complications (e.g., depression or foot ulcers).

Other Endocrine and Metabolic Disorders

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 the
side effects secondary to therapies based on naturally occurring
hormones.

Cystic Fibrosis and Inborn Errors

J. 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.

K. Production of stabilized biologically active proteins or peptides
useful for enzyme replacement therapy.

L. Development of small molecules that improve folding and activity for
enzymes defective in inborn errors.

M. 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.

[]{#__RefHeading___Toc219687110 .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.

P. Development of non-invasive imaging methods to quantitatively assess
fatty liver in patients.

Q. Development of non-invasive imaging methods to quantitatively assess
liver fibrosis in patients.

R. Development of non-invasive methods to quantitatively assess liver
iron content in patients.

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 devices/ techniques to measure portal
pressure for evaluating portal hypertension in patients with cirrhosis.

L. Development of an extracorporeal liver assist device to provide
temporary therapeutic assistance in cases such as fulminant hepatic
failure or drug overdose.

M. Development of non-occluding stents for use in the biliary tract and
in transjugular intra-hepatic porto-systemic shunts (TIPS).

N. Development of cryopreservation techniques for human hepatocytes that
would maximize viability and cell culture growth potential of thawed
cells.

O. Creation of artificial organs or development of effective xenographic
techniques for liver transplantation.

P. Development of molecular standards for Hepatitis C virus quantitation
and typing.

Q. Development of molecular standards for Hepatitis B virus quantitation
and typing.

R. Development of an economical, accurate, and fast test for glutens and
glidins in foods.

S. Development of humanized mouse models of multi-allelic diseases.

T. Development of measurements to quantitate phenotypic or metabolic
markers of disease progression in animal models, thus reducing the
numbers of animals needed.

U. Identification of surrogate markers looking at the plasma/sera
proteome or metabolome at different stages of digestive or liver
disease.

V. Development of novel proteomic or metabolomic technologies designed
to study digestive and liver diseases, and their complications.

W. Identification of novel drug targets or novel therapeutic agents
using proteomic approaches that might be relevant to digestive and liver
diseases, and their complications.

X. Use of high throughput proteomic and metabolomic technologies for
toxicology studies of drugs that might be relevant to digestive and
liver diseases, and their complications.

Y. Development of biomarkers or imaging methods that quantitatively
measure hepatic regeneration.

Z. Development of biomarkers that quantitatively assess the degree to
cold and warm ischemia in donor liver organs.

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, prevention of weight gain and/or increasing
physical activity such as hand-held computers and web-based programs.

C. Development of devices/equipment/ interventions to encourage
"activity" while engaged in sedentary activities (e.g., watching
television or sitting at a desk).

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___Toc219687111 .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. Bioinformatics 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\. Application of Proteomics and Metabolomics to Kidney, Urologic and
Hematologic Diseases

A Identification of surrogate markers in the plasma or serum that
correlate with acute or chronic kidney disease, urologic diseases of the
prostate or bladder, or disregulation of iron metabolism or other
hematologic diseases (not leukemia), such as hemoglobinopathies or
thalassemia.

B. Identification or development of novel proteomic or metabolomic
technologies designed to study kidney, urologic, or hematologic
diseases.

III\. 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\. Development of methods / agents to reduce hemodialysis or peritoneal
dialysis catheter-related infections.

5\. Characterization of changes in kidney hormonal function in kidney
disease at various stages of severity.

6\. Development of new biomarkers for early detection of kidney
dysfunction, prediction of progression, and early indication of
recovery.

7\. Development of rapid, accurate, and cost effective means of
quantifying urine albumin.

IV\. Urology

A. Analyses of factors responsible for initiation and progression of
benign prostatic Hyperplasia (BPH) leading to the development of a
diagnostic tool. Development of animal, computer, or in-vitro models for
the study of BPH, including culture conditions for in vitro culture of
cells from benign prostatic hyperplasia.

B. Development of diagnostic modes to clinically non-invasively or
minimal-invasively measure bladder obstruction before and after surgical
or pharmaceutical intervention and/ or treatment devices for bladder
outlet obstruction.

C. Prevention, diagnostic, or treatment modalities for urinary tract
infections.

D. 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. Development of
diagnostic device for biochemical profiling of stones either in-vitro or
in-vivo.

E. Development of localization methods through imaging or non-invasive
methods or instrumentation using minimally-invasive methods to access
stones for therapy. Methods to directly improve access to difficult
stones.

F. Development of additional therapeutic agents for prevention and/or
treatment of urolithiasis.

G. Development of more real-time diagnostic assessment of bladder and
urinary function using non-invasive or minimally invasive measures,
which can include neuro-pharmacological/neuro-physiological assessments
in urodynamics.

H. Objective and diagnostic measurement devices or methods for
assessment of urinary leakage and incontinence, both in adults and
children.

I. Development of non invasive or minimally invasive treatment methods
or pharmacological for urinary incontinence and/or bladder instability.

J. Non-invasive or minimally invasive methods to diagnosis bladder
inflammation or bladder epithelial and/ or bladder wall changes of
non-cancerous origin.

K. Non-invasive, reduced or non-radiological diagnostic methods for
evaluating vesico-ureteral reflux in children and infants.

L. Methods for determining inflammatory cytokines, histamines, etc., in
voided urine, as markers for lower urinary tract inflammatory processes.

M. Development of simple diagnostic kits for evaluating growth factors
in urine in a clinical laboratory.

V. 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, validating, and
standardizing organ specific iron concentration measurements as 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.

M. Development and validation of a sensitive, specific, reproducible,
quantitative, and clinically applicable assay method for measuring serum
hepcidin levels.

N. Design and validation of novel therapeutic agents that modulate
hepcidin expression and/or activity *in vivo*.

[]{#__RefHeading___Toc219687112 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

Diabetes, Endocrinology and Metabolic Diseases

Karen Salomon, M.S.

Program Analyst

National Institute of Diabetes and Digestive and Kidney Diseases

301-594-7733

Email: <salomonk@niddk.nih.gov>

Digestive Diseases and Nutrition

Christine Densmore, M.S.

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. Debuene Chang

National Institute of Diabetes and Digestive and Kidney Diseases

301-594-7717; Fax: 301-480-3510

Email: <changtd@mail.nih.gov>

*[Hematology]{.underline}*

Dan Wright

National Institute of Diabetes and Digestive and Kidney Diseases

301-594-7717, Fax: 301-480-3510

Email: <wrightdan@mail.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___Toc219687113 .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___Toc219687114 .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. The desired
application of these technologies and assays is in population-based
(epidemiological) or clinical research and practice. Indeed there is an
overall NIH effort in Exposure Biology which is part of a larger Gene
and Environment Initiative (GEI). Applicants in the exposure biology
aspect of the NIEHS SBIR program should also examine the GEI website as
there are additional RFAs available in this area
(<http://www.gei.nih.gov/exposurebiology>).

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

The 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. These
airborne/point of contact devices should be capable of measuring
simultaneously and in near real time, multiple agents within a single
exposure class (e.g. multiple types of metals, multiple size fractions
of particulate matter, multiple components of diesel exhaust) and/or
multiple agents across more than one exposure class. Exposures of
interest include ozone, particulate matter, diesel exhaust, metals (e.g.
arsenic, cadmium, mercury), volatile organic compounds, polybrominated
diphenyls (PBDEs), polycyclic aromatic hydrocarbons (PAHs),
mold/microbial toxins, allergens and pesticides/herbicides. 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).

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

The NIEHS is interested in developing technologies and devices to
generate precise indicators (or markers) of the biological response to
environmental exposures. 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 in easily accessible biosamples (blood,
urine, saliva, buccal samples, nasal mucosa or exhaled breath) for 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-throughput and sensitive technologies and assays
for the detection and quantification of molecular changes in genes
(genomics), proteins (proteomics), or metabolites (metabolomics), that
are reflective of the early response to environmental exposure.

B. Development of biomarkers of response to environmental agents that
will define a pattern of response at a single level (i.e. a molecular
signature) or at multiple levels (i.e. molecular, cellular, and/or
physiological responses).

C. Comparison of panels of biomarkers in multiple tissues progressing
from invasive to noninvasive specimens.

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.

F. Comparison of patterns of response to environmental agents across
species including humans.

3\. Technologies for Generating Precise Measurements of Internal Dose of
Environmental Agents

The NIEHS is interested in developing technologies and devices to
generate precise measurements of internal dose of individual
environmental agents and or their metabolites in real time and over
time. It would be especially valuable to analyze internal dose over time
of multiple agents within a single class or multiple agents across more
than one class. As with the external exposure sensors throughput should
be an important component of the product.

Examples include:

A. Development of sensors for measuring the levels of toxicants in bio
specimens easily attained by an individual such as finger prick, buccal
cell, exhaled breath or urine.

B. The development of biocompatible in vivo sensors for measuring target
organ distribution of specific agents.

C. The development of integrated devices combining the functionality of
external exposure sensors, internal exposure sensors and biological
response sensors.

[]{#__RefHeading___Toc219687115 .anchor}Hazardous Waste Assessment,
Evaluation and Remediation Program

The 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___Toc219687116 .anchor}Predictive Test Systems for
Safety Evaluation Program

The 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___Toc219687117 .anchor}Educational and Training
Resources Program

The 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___Toc219687118 .anchor}Intervention Program

The NIEHS is interested in developing new and improved therapeutics or
diagnostic technologies to prevent or mitigate the toxic effects from
exposures to chemical threats, defined as toxic chemicals or agents that
could be used in a terrorist attack against civilians, or those that
could be released at toxic levels by accident or natural disaster. This
includes the development of new (or support of existing) partnerships
between small business and not-for-profit laboratories engaged in this
research.

The NIEHS is also interested in the development and validation of
strategies for mitigating the effects of exposures to environmental
chemicals such as metals, pesticides, air pollutants and chemicals with
endocrine activity. These strategies could include interventions to
inhibit toxicity before it occurs or interventions that would reduce
toxicity after exposures.

[]{#__RefHeading___Toc219687119 .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 (K3-15)

Research Triangle Park, NC 27709

\(919\) 541-0781, Fax: (919) 541-5064

Email: <heindelj@niehs.nih.gov>

For administrative and business management questions, contact:

Ms. Pam Clark

National Institute of Environmental Health Sciences

Division of Extramural Research and Training

Grants Management Branch

POB 121233 (K3-11)

Research Triangle Park, NC, 27709

\(919\) 541-7629, Fax: (919) 541-2860

Email: <evans3@niehs.nih.gov>

For express mail:

79 T.W. Alexander Drive

4401 Bldg, 3rd Floor

[]{#__RefHeading___Toc219687120 .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 of vision research are
encouraged. Examples that may be of interest to small businesses are
provided below, but this list is not meant to be exhaustive.

[]{#__RefHeading___Toc219687121 .anchor}Phase II Competing Renewal
Awards

The NEI will accept Phase II SBIR Competing Renewal grant applications
from NEI-supported Phase II SBIR awardees to continue the process of
developing technologies that ultimately require federal regulatory
approval. Such technologies include, but are not limited to,
pharmacologic agents, biological products, devices, etc., related to the
mission of the NEI. This renewal grant should allow small businesses to
get to a stage where interest and investment by third parties is more
likely. Competing Renewal application must be a renewal and logical
extension of a previously completed NEI-supported Phase II (R44) SBIR
grant. NEI 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 \$750,000 total costs per year and time periods up to two
(2) years may be requested for this Phase II Competing Renewal
opportunity.

Potential applicants are strongly advised to contact Dr. Jerome Wujek
(contact information provided below) before beginning the process of
putting an application together.

The following examples would make appropriate topics for proposed NEI
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 New Drug
    Application (NDA).

-   FDA-required pre-clinical and clinical safety and effectiveness
    studies of medical devices and tissue engineered products for an
    Investigational Device Exemption (IDE) or Pre-market Approval (PMA).

-   FDA-required evaluation of novel imaging approaches for diagnostic
    purposes.

Direct your questions about scientific/research issues to:

Jerome Wujek, Ph.D.

National Eye Institute

5635 Fishers Lane, Suite 1300, MSC 9300

Bethesda, MD 20892-9300

Rockville, MD 20852 (for express/courier service)

301-451-2020, Fax: 301-402-0528

Email: <wujekjer@nei.nih.gov>

[]{#__RefHeading___Toc219687122 .anchor}General Research Topics

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. This encompasses research and development of innovative enabling
technologies in areas of genomics, proteomics and nanotechnology. More
specific topics include drug discovery, high throughput assays, drug
delivery systems, gene therapy and cell-based therapies, development of
in vitro and in vivo disease models, surgical devices and materials,
telemedicine and teaching tools, and design and fabrication of new or
improved ophthalmic instruments for diagnosis and treatment of eye
disorders.

[]{#__RefHeading___Toc219687123 .anchor}Retinal Diseases Program

Research and development of new therapeutic approaches for inflammatory
and degenerative diseases and for inhibition of abnormal angiogenesis in
the retina and choroid; development of better methods of diagnosing and
treating diabetic retinopathy and other vascular diseases; 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;
development of retinal prostheses to help restore visual function;
identification and characterization of factors regulating retinal
cellular proliferation and development that will facilitate retinal
regeneration and function; development of methods for cell or tissue
transplantation.

[]{#__RefHeading___Toc219687124 .anchor}Corneal Diseases Program

Research and development of new therapeutic agents and drug delivery
methods for the treatment of corneal injury, infection, dry eye and
other ocular surface disorders; development of new biomaterials for
corneal prostheses and corneal transplants; development of instruments
and procedures for correcting the refractive power of the cornea and/or
measuring the cornea\'s optical properties or other physiological
properties; new materials and manufacturing processes for eyeglasses and
contact lenses.

[]{#__RefHeading___Toc219687125 .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 new biomaterials for replacement of the natural
lens; development of accommodative intraocular lenses.

[]{#__RefHeading___Toc219687126 .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___Toc219687127 .anchor}Strabismus, Amblyopia, and
Visual Processing Program

Research and 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; development of new
tools and techniques for vision screening; development of innovative
techniques to study factors that facilitate regeneration and guidance of
nerve fibers.

[]{#__RefHeading___Toc219687128 .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 and everyday living needs of blind or visually-impaired
persons.

[]{#__RefHeading___Toc219687129 .anchor}Additional Information

The NEI\'s programs are described in more 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/).

For more information on research topics, contact:

Jerome Wujek, Ph.D.

National Eye Institute

301-451-2020, Fax: 301-402-0528

Email: <wujekjer@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___Toc219687130 .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/About/ContactByArea.htm>). It also includes
links to program announcements that highlight NIGMS areas of special
emphasis (<http://www.nigms.nih.gov/Research>). 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___Toc219687131 .anchor}Phase II Competing Renewal
Awards

NIGMS will accept Phase II SBIR-only 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 reach 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 NIGMS. The
previously funded Phase II SBIR 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 \$750,000
total costs per year and time periods up to 2 years may be requested for
this Phase II Competing Renewal opportunity. These awards are intended
to support completion of research needed to obtain an IND or IDE.
Applicants must provide evidence that they have consulted formally with
the FDA concerning the research needed for the development of a drug,
biologic or medical device and that the proposed research will address
these regulatory requirements. Such evidence should include FDA
correspondence from a pre-IND meeting for an IND application or a
pre-IDE meeting for an IDE application, and the status of the 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 NIGMS 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-09-XXX)

[]{#__RefHeading___Toc219687132 .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.

4\. New methods and technology which enhance the efficiency and reduce
the costs of structural genomics protein structure determination
pipelines.

5\. New methods to facilitate the structure determination of large
macromolecular assemblies.

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. 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 the simulation and prediction of the dynamics
of biological macromolecules.

G. 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___Toc219687133 .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, 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 expression, 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 and birth
defects.

I. Development of quantitative approaches to the analysis of complex
biological systems.

J. Development of tools and technologies to detect and monitor complex
human phenotypes or traits.

K. Development of improved technology to scale up the growth of induced
pluripotent stem cells in culture and to regulate their differentiation
state

L. Development of technology to derive and expand pluripotent cell
populations from non-embryonic sources, for example, induced pluripotent
stem cells (iPS).

M. Development of markers, reagents and tools to characterize the unique
properties of iPS cell lines and to distinguish them from adult stem
cells and more differentiated cells.

N. Development of human embryonic stem cell lines and iPS cells as a
primary cell type to be used as a model system for drug discovery.

O. 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.

P. Development of methods for chemical modifications that improve the
properties of nucleic acids for gene silencing.

Q. Improvement in procedures (statistical, computational, laboratory)
for the high- and medium-throughput analysis of gene expression patterns
and regulatory networks.

R. Development or improvement of methods for high throughput detection
of epigenomic changes.

S. Development or improvement of methods for characterizing the
metabolic interactions of complex communities of microorganisms
particularly those involved in host-microbe interactions.

[]{#__RefHeading___Toc219687134 .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 cell signaling molecules and signaling
intermediates, particularly those related to G-protein coupled
receptors. 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
on wound healing and tissue repair. Research on the causes and
treatments for common complications of critically ill patients (sepsis,
systemic inflammatory response syndrome, multiple organ failure),
especially directed towards the role of the inflammatory and innate
immune 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
chemical entities 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.

3\. Methods for rapid purification of natural products.

4\. Methods for rapid determination of natural product structures.

5\. Methods for efficient production of natural products.

6\. Universal expression systems for heterologous production of natural
products.

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. Development of strategies, methods, or molecular based treatments to
improve the speed and outcome of wound healing or to induce regeneration
as a substitute to normal wound healing.

F. Metabolomics/metabonomics of injury and/or critical illness.

G. Improved systems for collection, processing, and analysis of real
time physiological data from injured or critically ill patients.
Application of systems biology or complexity theory approaches towards
understanding the physiology of injured and critically ill organisms.

H. Development of tools, software, algorithms, etc. needed to link
clinical, demographic, physiological, genomic, proteomic or other
datasets of injured or critically ill organisms.

I. Development of strategies, methods, or new technologies to improve
the delivery, monitoring, safety and efficacy of anesthesia.

J. Research to improve drug design.

1\. Methods for understanding of structure-activity relationships.

2\. Mechanisms of drug-receptor interactions.

3\. Development of molecular diversity libraries.

K. 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.

L. Application of pharmacokinetic and pharmaceutical principles to the
study of large biomolecules, such as proteins, polypeptides, and
oligonucleotides.

M. Development of novel targeted delivery systems for both conventional
drugs and large molecules.

N. 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.

O. Development of novel in vivo and in vitro methods to predict
toxicities of pharmacologic agents.

P. 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.

Q. Development of bioinformatic, mathematical, and/or computational
approaches/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.

R. Development of ontologies and modules useful for combining and mining
databases containing genotype and phenotype information in order to
discover correlations for drug effects, either therapeutic or adverse.

S. Development of methods for high throughput structural analysis of the
glycoconjugates of proteins and lipids; synthesis of defined
carbohydrate libraries especially those applicable for screening for
glycomic biomarkers, assessing carbohydrate protein interactions, and
development of glycan arrays; early detection of disease via glycomic
based biomarkers.

T. 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.

U. 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.

V. Development of methods to create site-directed and knock-out
mutations of mitochondrially-encoded genes in higher eukaryotic cells
and experimental animals.

W. 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.

X. 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.

Y. 1. Development of carbohydrate specific databases as well as
informatics tools to mine carbohydrate data bases.

2\. Development of new facile methodologies to rapidly synthesize and
expand defined carbohydrate libraries

3\. Development of linker methods for carbohydrates.

4\. Development of methods for exploring glycan-protein, glycan-lipid,
and glycan-glycan interactions

5\. Development of well characterized commercial sources of
glycosyltransferases and glycosidases that can be used as research tools
by the scientific community.

Z. 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___Toc219687135 .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___Toc219687136 .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

301-594-5136, Fax: 301-480-2554

Email: <molnarp@nigms.nih.gov>

[]{#__RefHeading___Toc219687137 .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. It also supports research on the clinical use of
blood and all aspects of the management and safety of blood resources.
The NHLBI SBIR/STTR program fosters basic, applied, and clinical
research on all product and service development related to the mission
of the NHLBI.

For more specific information about areas of interest to the NHLBI and a
link to the NHLBI Strategic Plan, 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:

[]{#__RefHeading___Toc219687138 .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) clearance
or approval of the Phase II product in the form of a Premarket
Notification (510(k)), Investigational Device Exemption (IDE), Premarket
Approval Application (PMA), Humanitarian Device Exemption (HDE),
Biologics License Application (BLA), Investigational New Drug (IND), or
New Drug Application (NDA). This renewal grant should allow small
businesses to commercialize their product or get to a stage where
interest and investment by third parties is more likely. Such products
include, but are not limited to medical devices, biological products,
and drugs 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 are to submit an
application no later than the first six receipt dates following
expiration of the previous Phase II project budget period. Exceptions to
this submission timing are rare and must first be discussed with NHLBI
program staff.

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.

NHLBI Phase II awardees planning to apply to this renewal opportunity
are expected to have already initiated interactions with the FDA, so
that they understand the regulatory process and factor that into their
renewal research plan. Applicants must include a brief description of
the FDA regulatory pathway being pursued for their project and a
timeline for this pathway in the Experimental/Research Design and
Methods Section of the application. An applicant must also submit
evidence that they have contacted the appropriate FDA Center and that
their research plan and objectives follow FDA requirements or guidance
for the further development of their proposed medical device, drug, or
biologic. Examples that provide evidence of FDA interaction are letters
or emails between the company and the appropriate FDA Center personnel
or meeting minutes concerning a presubmission meeting or regarding a
510(k), IDE, PMA, HDE, BLA, IND, or NDA application. Copies of these
letters, emails or minutes should be attached in section Item 16,
Letters of Support in the PHS398 Research Plan Component. Applicants may
also provide details of their interaction with the FDA in the
description of their regulatory pathway. This should include the FDA
contact and date of interaction.

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

-   Brief project description (less than one page)

-   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, 510(k) clearance of PMA approval.

-   FDA-required biocompatibility studies of surface materials of
    putative medical implants or other studies needed for 510(k)
    clearance or PMA approval.

-   FDA-required assessments of novel imaging systems.

If the application results in an award from NHLBI, we will request that
the grantee provide information to their Project Officer about the
ongoing status of their interactions with the FDA and any regulatory
issues that might come up as the project proceeds. If feasible, grantees
should formally invite their Project Officer to participate with them in
their interactions with the FDA during the course of the project. We
also encourage the grantee to inform their NHLBI Program Officer when
they have received the relevant FDA clearance.

Helpful FDA websites for initiating FDA communication:

Office of Combination Products

<http://www.fda.gov/oc/combination/>

Center for Drug Evaluation and Research (CDER)

<http://www.fda.gov/cder/index.html><http://www.fda.gov/cder/>

Drug Approval Database<http://www.fda.gov/oc/combination/>

<http://www.accessdata.fda.gov/scripts/cder/drugsatfda/>

CDER \"Information for Industry\"

<http://www.fda.gov/cder/info/industry.htm>

Center for Biologics Evaluation and Research (CBER)

<http://www.fda.gov/cber/index.html>

Center for Devices and Radiological Health (CDHR)

<http://www.fda.gov/cdrh/index.html>

CDRH Device Advice

<http://www.fda.gov/cdrh/devadvice/>

Contacts in CDRH, including DSMICA (Division of Small Manufacturers,
International, and Consumer Assistance

<http://www.fda.gov/cdrh/contacts.html>

CDRH User Fee Information

<http://www.fda.gov/cdrh/mdufma/index.html>

Device Clearances and Approvals

<http://www.fda.gov/cdrh/mdufma/index.html> Select: "Premarket
Approvals:" or Premarket Notifications (510(k))s.

Direct questions about scientific/research issues to:

*[Cardiovascular Diseases]{.underline}*

J. Timothy Baldwin, Ph.D.

Division of Cardiovascular Diseases

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 8206

Bethesda, MD 20892-7940

Telephone: 301-435-0513

Fax: 301-480-1454

Email: <baldwint@nhlbi.nih.gov>

Bishow Adhikari, Ph.D.

Division of Cardiovascular Diseases

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 8186

Bethesda, MD 20892-7956

Phone: 301-435-0504

Fax: 301-480-7404

Email: <adikarb@nhlbi.nih.gov>

*[Lung and Sleep]{.underline}*

Mrs. Ann Rothgeb

Division of Lung Diseases

National Heart, Lung, and Blood Institute

6701 Rockledge Drive

Bethesda, MD 20892-7952

Telephone: 301-435-0202

Fax: 301-480-3557

Email: <ar31t@nih.gov>

*[Blood]{.underline}*

Phyllis Mitchell, M.S.

Division of Blood Diseases and Resources

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 9143

Bethesda, MD 20892-7950

Telephone: 301-435-0481

Fax: 301-480-0867

Email: <mitchelp@nhlbi.nih.gov>

*[Prevention and Population Sciences]{.underline}*

Shari Eason Ludlam, MPH

Division of Prevention and Population Sciences

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, (MSC 7936)

Bethesda, MD 20892-7936

Telephone: 301-435-6667

Fax: (301)480-5158

Email: <ludlams@nhlbi.nih.gov>

Paula T. Einhorn, M.D., M.S.

Division of Prevention and Population Sciences

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 10222

Bethesda, MD 20892-7936

Telephone: 301-435-0563

Fax: 301-480-1773

Email: <einhornp@nhlbi.nih.gov>

[]{#__RefHeading___Toc219687139 .anchor}Cardiovascular Diseases

The NHLBI Division of Cardiovascular Diseases (DCVD) plans and directs
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 DCVD 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 DCVD
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 five branches: the Advanced Technologies and Surgery
Branch, the Atherothrombosis and Coronary Artery Disease Branch, the
Heart Development and Structural Diseases Branch, the Heart Failure and
Arrhythmias Branch, and the Vascular Biology and Hypertension Branch, in
addition to a Research Training and Special Programs Group.

*[Advanced Technologies and Surgery Branch]{.underline}*. Supports
basic, translational, and clinical research on innovative and developing
technologies for the diagnosis, prevention, and treatment of
cardiovascular diseases.

*[Atherothrombosis and Coronary Artery Disease Branch.]{.underline}*
Supports basic, translational, and clinical research on the etiology,
pathogenesis, prevention, diagnosis, and treatment of coronary artery
disease and atherothrombosis.

*[Heart Development and Structural Diseases Branch.]{.underline}*
Supports basic, applied, and clinical research in normal and abnormal
cardiovascular development as well as the etiology, pathogenesis,
prevention, diagnosis, treatment of pediatric and adult structural heart
disease, and heart transplantation.

*[Heart Failure and Arrhythmias Branch.]{.underline}* Supports basic,
translational, and clinical research on normal cardiac function and
pathogenesis to improve the diagnosis, treatment, and prevention of
heart failure and arrhythmias.

*[Vascular Biology & Hypertension Branch.]{.underline}* Supports basic,
translational, and clinical research on vascular biology and the
etiology, pathogenesis, prevention, diagnosis, and treatment of
hypertension and vascular diseases.

Research topics of interest to the Division of Cardiovascular 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, intracardiac hemodynamic monitors, etc.):

a\. Novel technologies (e.g., nanofabrication), 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

j\. Devices designed specifically for pediatric patients and/or patients
with congenital heart disease

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\. Percutaneous valve technology

5\. Biological, chemical, and mechanical sensors

6\. Diagnostic instrumentation for the mouse and rat

7\. Devices to improve resuscitation outcomes

8\. Point-of-care (POC) devices for monitoring and diagnostics

a\. Biosensors for detection of early ischemia in the absence of
necrosis

b\. Minimally-invasive monitoring of heart rhythm, cardiac hemodynamics
and/or blood pressure

B. Computing and Informatics

1\. Computational Modeling:

a\. Systems biology approaches to study complex disease

b\. Mathematical and computer modeling of the cardiovascular system in
health and disease. Examples include: vessel wall biology; hemodynamics
in complex congenital heart disease; structure, function, and electrical
activity of the normal and diseased heart; blood pressure regulation

c\. Optimization of implantable defibrillator algorithms for arrhythmia
prediction, efficient intervention, device fault detection or early
failure detection

2\. Informatics:

a\. Novel use of information technology to enhance adherence to medical
regimens or promote translational research

b\. Approaches to integrating diverse types of data from cardiovascular
research

C. Animal Models

1\. Development of phenotypic screening methods in the mouse for
cardiovascular diseases

2\. Animal models for assessing genetic determinants of disease

3\. Animal models of cardiovascular diseases. Examples include:
complications of diabetes mellitus, cerebrovascular disease,
arrhythmias, aortic aneurysms, and lower extremity arterial disease

D. OMICS Methods and Analytical Approaches

1\. Genetics and epigenetics:

a\. Relationship, structure, and function of genes and their products

b\. Technologies for gene discovery, assessment, and diagnostics

c\. Genetics of complex diseases --gene/gene and gene/environment
interactions, epigenetics (heritable, non-sequence variations in DNA and
its associated proteins)

d\. Pharmacogenetics/Pharmacogenomics and personalized medicine

2\. Genomics

3\. Metabolomics

4\. Proteomics

5\. RNA - Development of new and improved antisense agents and RNA
interference (RNAi) technologies for cardiovascular disease therapies

E. Preventive Approaches

1\. Nutrition and dietary interventions and products

2\. Technologies to assess energy balance and control weight

F. Transplantation

1\. Methods to increase success of cardiac xeno-transplants

2\. Methods to induce tolerance to cardiac allografts

3\. Non-invasive methods to diagnose cardiac allograft vasculopathy

4\. Preservation methods for cardiovascular tissues or organs for use in
transplantation and in research studies

5\. Pediatric heart transplantation

G. Training and Education

1\. Instructional, research, and clinical computer programs for the
normal and abnormal cardiovascular system

2\. Educational materials and approaches targeting self-directed or
supervised exercise therapy for treatment and management of peripheral
arterial disease, coronary heart disease or heart failure

H. Diagnostic and Therapeutic Approaches

1\. Device-Related:

a\. Interventions to improve resuscitation outcomes

b\. Device-based approaches aimed at preventing cardiac
ischemia/reperfusion injury

c\. Improved devices and technologies to detect and treat arrhythmias

d\. Robotics in treatment of cardiovascular disease. For example:
treatment of congenital heart disease

e\. Computer-assisted surgery for treating cardiovascular diseases

f\. Point-of-care (POC) approaches and techniques

g\. Technologies targeting self-directed or supervised exercise therapy
for treatment and management of peripheral arterial disease

h\. Non-invasive device strategy to monitor ambulatory heart rhythm over
extended period

2\. Cell or Gene-Based:

a\. Development of gene-based or cell-based therapies for cardiovascular
diseases

b\. Tissue engineering and cell or gene-based approaches for repair or
replacement of damaged or diseased tissue

c\. Genetic testing or screening for inherited cardiovascular diseases
and defects

d\. Biomarkers and surrogate markers for risk assessment, detection, and
monitoring of cardiovascular diseases

e\. Development of viral and non-viral vectors for gene therapy for
cardiovascular diseases

f\. Pro- and anti-angiogenic and vasculogenic genes, proteins and drugs

3\. Research:

a\. Approaches and technologies to measure lipid content in the blood

b\. Non-invasive methods of detecting cardiac rejection, particularly in
infants and young children

c\. Non-toxic and selective molecular cages for delivering short-lived
vasoactive agents to the vasculature

d\. High-throughput assays or screening for cardiovascular research and
disease detection

e\. Non-invasive diagnostic tests. For example: salt sensitivity;
vascular and renal tubular fluid dynamics

f\. Heart failure, early detection and treatment strategies

g\. Novel approaches to reduce cardiac ischemia/reperfusion injury
following myocardial infarction

h\. Anti-hypertensive drugs from natural and synthetic sources

i\. Vaccines for the prevention or treatment of atherosclerosis or other
cardiovascular diseases

j\. Technologies, tools, and/or processes to better study transient
molecular complexes that are an integral part of normal cell physiology
or that play a role in cardiovascular disease processes

k\. Tools to investigate mitochondrial functions and interactions with
cell components in vivo or in intact single cells

l\. Atrial Fibrillation, tools for non-invasive strategy for early
detection and management

I. Imaging

1\. Molecular and cellular imaging, including imaging to detect gene
expression and to track viable implanted stem cells

2\. Imaging methods to measure molecular events in living cells in real
time. For example: luminescent dyes to measure toxic metabolic
intermediates; optical imaging methods for dynamic tracking of reactive
species within organelles

3\. New medical imaging systems, enhancements and applications

4\. Imaging characterizing vessel walls and lesions

5\. Clinical imaging in congenital heart disease

6\. Neuro-imaging in hypertension

7\. Radiologic phantoms mimicking the human cardiovascular system

8\. High resolution functional and molecular imaging of the human
lymphatic system

9\. 3-D fetal echocardiography or magnetocardiography

10\. Image-guided therapy: Catheter and imaging guidance system for
mapping and ablation to treat cardiac arrhythmias

11\. MRI-compatible diagnostic electrophysiology catheters and
MRI-compatible ablation catheters

12\. New ambulatory imaging of cardiac rhythm to detect irregular or
aberrant atrial or ventricular impulses over long (week(s)) period of
observation.

[]{#__RefHeading___Toc219687140 .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. The Division
has three branches: the Airway Biology and Disease Branch, the Lung
Biology and Disease Branch, and the National Center on Sleep Disorders
Research.

*[Airway Biology and Disease Branch]{.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 Branch]{.underline}*. Supports research,
education, and training programs in lung cell and vascular biology; lung
growth and development, stem cell biology and lung regeneration,
pediatric lung disease; acute lung injury and critical care medicine;
interstitial lung diseases, including pulmonary fibrosis and
sarcoidosis; and AIDS and tuberculosis.

*[National Center for Sleep Disorders Research]{.underline}*. Focuses on
basic research using state-of-the-art approaches to elucidate the
functions of sleep including the fundamental regulation of genomic
function and circadian timing in peripheral tissues; 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, especially sleep disordered breathing.

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\. Tools to diagnose and treat respiratory abnormalities during sleep
in infants, children, and adults

3\. Diagnostic proteomics and metabolomics, including methods for early
diagnosis of lung disease and characterization of the
function/dysfunction of particular cell types

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\. Probes to non-invasively monitor arterial carbon dioxide

10\. Use of ambulatory monitoring techniques to diagnose and manage
respiratory disorders of sleep

11\. Ambulatory monitoring of oxygenation in infants

12\. Computerized tomography to quantify and monitor pulmonary disease
processes

13\. Virtual bronchoscopy (this is a radiologic 3D reconstruction of the
lungs with imaging to approximate bronchoscopy)

14\. Novel methods for bioassays

15\. Methodologies that provide an objective and semi-quantitative
assessment of sleepiness in children

16\. Non-invasive imaging technologies to assess neurophysiological and
regional brain blood flow changes associated with sleep disorders and
other causes of excessive daytime sleepiness

17\. Develop placebos for inhaled medications used in clinical trials of
lung diseases

18\. Detection of injury and repair of the lungs (e.g. after aspiration,
near drowning, ARDS)

B. Information and Health Education Tools

1\. Health information 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\. Information systems to coordinate patient management and monitoring
among patients and health care professionals

4\. Innovative smoking cessation programs

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

8\. Methods to improve patient compliance with sleep disordered
breathing treatments

9\. Develop and test novel and effective approaches to educate the
public, physicians, and/or health care systems to increase patient and
provider participation in lung and sleep research

10\. Develop and test novel and effective approaches to increase patient
and/or provider adherence to clinical practice guidelines for management
of lung diseases and sleep disorders

11\. Develop and test novel and effective approaches to build capacity
for self-management of chronic lung diseases and sleep disorders

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, particularly for young infants
and/or children

4\. Improved aerosol delivery systems for ventilated patients

5\. Improved devices for continuous oxygen administration, including
airline travel

6\. Improved extracorporeal or implantable devices for blood gas
exchange (artificial lung)

7\. 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

8\. Personal exposure monitors for aeroallergens and other environmental
pollutants

9\. Personal exposure monitors for measures of environmental exposures

10\. Thrombo-resistant materials for extracorporeal or implantable
devices for blood gas exchange and for indwelling catheters

11\. Devices for the detection of periodic breathing, or brief (\<20
sec.) central or obstructive apnea, associated with hypoxemia for
infants at risk of sudden infant death syndrome (SIDS)

12\. Improved CPAP interfaces (i.e., nasal, face masks) for young
children and individuals with craniofacial abnormalities

13\. Improved low-flow oxygen delivery systems (including cannula) that
permit mobility for young children

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 loss of epithelial integrity

8\. Measurement of exhaled nitric oxide

9\. Measurement of airway surface liquid

10\. Measurement of pH in airways

11\. Identify lung stem cell types

12\. Identify species and strain differences of Pneumocystis carinii

13\. Isolate, identify, and characterize cells found in pulmonary
granulomas

14\. Three-dimensional static, mathematical, cell culture models of
airways and alveoli to define parameters determining aeropollutant
absorption, deposition, and effects

15\. Develop technologies and tools for use in genomic or proteomic
investigations of pulmonary diseases

16\. New technologies and instrumentation scaled for high-throughput
phenotypic characterization of sleep in animal models

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

18\. Simultaneous assessment of physical activity and sleep.
Dual-purpose ambulatory devices, equally suitable for the objective
assessment of physical activity and sleep in population-based cohorts

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\. Pharmacological means of stimulating growth and repair of alveoli
and reparative or restorative elastogenesis in lungs suffering
emphysematous changes

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

7\. New pharmacological agents for the treatment of sleep disorders,
especially sleep disordered breathing

8\. New vaccination/immunomodulatory strategies to prevent exacerbations
of Chronic Lung Disease

[]{#__RefHeading___Toc219687141 .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,
on the causes, prevention, and treatment of nonmalignant blood diseases,
including anemias, sickle cell disease, and thalassemia; premalignant
processes such as myelodysplasia and myeloproliferative disorders;
hemophilia and other abnormalities of hemostasis and thrombosis; and
immune dysfunction. Funding encompasses a broad spectrum of research
ranging from basic biology to medical management of blood diseases. The
Division has a major responsibility for research to improve the adequacy
and safety of the nation\'s blood supply. It also plays a leading role
in transfusion medicine research and applying stem cell biology to the
development of new cell-based therapies to repair and regenerate human
tissues and organs. The Division has three branches: the Blood Diseases
Branch, the Thrombosis and Hemostasis Branch, and the Transfusion
Medicine and Cellular Therapeutics Branch.

*[Blood Diseases Branch]{.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 Branch.]{.underline}* Supports research and
training in occlusive disorders involved in deep vein thrombosis, in
cardiovascular diseases and stroke, and in bleeding disorders.

*[Transfusion Medicine and Cellular Therapeutics Branch]{.underline}*.
Supports research and training in transfusion medicine, blood safety and
resources, stem cell biology and disease, clinical cellular medicine;
and Resource Programs that provide phenotypically-characterized
biospecimens and GMP-grade cell therapies to the scientific community.

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

1\. Anemias including: sickle cell disease, thalassemia, Fanconi anemia,
Diamond Blackfan anemia, and other 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. Animal models for complications associated with transfusion of blood
products or cell-based therapies

1\. Transfusion Related Acute Lung Injury (TRALI)

2\. Transfusion-associated immuno and inflammatory complications
including alloimmunization

3\. Transfusion-transmitted infections such as Transmissible Spongiform
Encephalopathy (TSE)

4\. Idiopathic Pulmonary Syndrome

5\. Graft versus Host Disease

6\. Microoxygenation models to evaluate the effect of RBC transfusion

C. Animal models for the demonstration of safety and efficacy of novel
cellular therapies including hemoglobin oxygen carriers (HBOC)

D. Tools, reagents, and assays for investigations of blood diseases

1\. Nanotechnologies

2\. Proteomics

3\. Glycomics

4\. Genomics

5\. Non-invasive approaches to analytes

E. Assays and technologies

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 causing babesiosis, dengue fever, malaria, and the
transmissible spongiform encephalopathies such as variant
Creutzfeldt-Jakob Disease (vCJD)

9\. Diagnosis of inherited blood disorders

10\. Prolonging the in storage of transfusable blood components for
therapeutic uses

11\. Identification and characterization of microparticles and other
bioactive substances in stored transfusable blood components

12\. In vitro reduction inactivation or removal of microorganisms and
other infectious moieties from blood, blood components, and plasma
derivatives

13\. Platelet storage methods that preserve biological efficacy

14\. Synthesizing, screening, and evaluating the safety and efficacy of
therapeutic oxygen carriers

15\. Synthesizing or purifying plasma proteins for therapeutic use

16\. Measuring iron non-invasively

17\. Non-invasive measurement of blood cell counts or other blood
components

18\. MHC haplotype determination by methods such as DNA fingerprinting
techniques and single nucleotide polymorphisms

19\. Tracking of engrafted cells using imaging and/or other techniques

20\. Technologies to measure tissue microoxygenation

21\. Development of HLA and HNA antibody assays

22\. Cord blood collection devices

F. Technologies and strategies to improve blood donor screening
practices

G. 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

H. Cellular Therapies

1\. Expansion of cell populations

2\. Production and standardization of immune-modulating cytokines or
monoclonal antibodies

3\. Directed in vitro stem cell differentiation

4\. Development of in vivo techniques to monitor survival, growth and
development and differentiation of engrafted cells

5\. Reprogramming differentiated cells to increase their lineage
potential including the creation of induced pluripotent stem cells

I. Gene therapy vectors and delivery systems for the treatment of
hematologic genetic diseases

J. Prothrombotic and hemorrhagic biomarkers and risk factors

K. Computational models for blood diseases and complications associated
with transfusion of blood products and cellular therapies

L. Bioinformatics to store and analyze genes, proteins, and biomarkers
for hemostasis

M. Equipment and procedures for the collection, separation, processing,
preservation, storage, and distribution of blood and blood components
and other cell therapies

N. Education

1\. Patient and physician health education programs to improve patient
management and to prevent or reduce the impact of blood diseases

2\. Physician education programs to evaluate effectiveness and improve
adherence to transfusion medicine clinical guidelines

O. 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

3\. Community health education programs to increase blood donation

P. 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___Toc219687142 .anchor}Prevention and Population
Sciences

The NHLBI Division of Prevention and Population Sciences (DPPS) supports
and provides leadership for population- and clinic-based research on the
causes, prevention, and clinical care of cardiovascular, lung, and blood
diseases and sleep disorders. Research includes a broad array of
epidemiological studies to describe disease and risk factor patterns in
populations and to identify risk factors for disease; clinical trials of
interventions to prevent disease; studies of genetic, behavioral,
sociocultural, and environmental influences on disease risk and
outcomes; and studies of the application of prevention and treatment
strategies to determine how to improve clinical care and public health.
The Division also supports training and career development for these
areas of research. The Division has three branches and one office: the
Epidemiology Branch, the Clinical Applications and Prevention Branch,
the Women's Health Initiative Branch, and the Office of Biostatistics
Research.

*[Clinical Applications and Prevention Branch]{.underline}*. Supports,
designs, and conducts research on behavioral, environmental, clinical,
and healthcare approaches to reduce occurrence and consequences of
cardiovascular diseases.

*[Epidemiology Branch.]{.underline}* Supports, designs, and conducts
research in the epidemiology of cardiovascular, lung, blood and sleep
diseases and disorders.

*[Women's Health Initiative Branch.]{.underline}* Supports clinical
trials and observational studies to improve understanding the causes and
prevention of major diseases affecting the health of women. Current
studies focus on cardiovascular disease, cancer, and fractures, in
collaboration with NCI, NIAMS, NIA, NINDS, and ORWH.

*[Office of Biostatistics Research:]{.underline}* Provides statistical
expertise to members of all Divisions of the NHLBI and performs diverse
functions in planning, designing, implementing and analyzing
NHLBI-sponsored studies. The OBR is concerned with designing efficient
studies and monitoring data while studies are ongoing. The OBR's
methodological interest concern survival analysis, longitudinal data
analysis, and efficient study designs, including the monitoring of
ongoing clinical studies for efficacy and safety. Recently the OBR has
made contributions to statistical genetics and has extended its
expertise to bioinformatics.

Research topics of interest to the Division of Prevention and Population
Sciences 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

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. Preventative Approaches

1\. Nutrition and dietary interventions and products

2\. Technologies to control weight

L. Treatment agents or strategies, including medications and devices

M. Assay systems/techniques to measure patient responses to behavioral
or medical interventions

N. Materials, equipment and software for enhanced medical imaging
systems

O. Methods for communication of research results

P. Methods for collection, transmission, management and analysis of
clinical data

Q. Nutrition, physical activity, obesity, stress reduction and smoking
cessation interventions

R. Nutrition and physical activity measurement methods and devices

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

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

LL. Tools for disease self-management, including telemetric monitoring

[]{#__RefHeading___Toc219687143 .anchor}Other Research Topic(s) Within
the Mission of the Institute

For additional information on research topics, contact:

*[Cardiovascular Diseases]{.underline}*

J. Timothy Baldwin, Ph.D.

Division of Cardiovascular Diseases

National Heart, Lung and Blood Institute

6701 Rockledge Drive, Room 8206

Bethesda, MD 20892-7940

301-435-0513, Fax: (310) 480-1454

Email: <baldwint@nhlbi.nih.gov>

Pothur R. Srinivas, Ph.D.

Division of Cardiovascular Diseases

National Heart, Lung and Blood Institute

6701 Rockledge Drive, Room 8162

Bethesda, MD 20892-7956

301-435-0550, Fax: (310) 480-2858

Email: <srinivap@nhlbi.nih.gov>

Bishow Adhikari, Ph.D.

Division of Cardiovascular Diseases

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 8186

Bethesda, MD 20892-7956

Phone: 301-435-0504

Fax: 301-480-7404

Email: <adikarb@nhlbi.nih.gov>

*[Lung Diseases and Sleep Disorders]{.underline}*

Ms. Ann Rothgeb

Division of Lung Diseases

6701 Rockledge Drive

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 9143

Bethesda, MD 20892-7950

301-435-0481, Fax: 301-480-0867

Email: <pm154p@nih.gov>

*[Prevention and Population Sciences]{.underline}*

Shari Eason Ludlam, MPH

Division of Prevention and Population Sciences

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, (MSC 7936)

Bethesda, MD 20892-7936

Telephone: 301-435-6667

Fax: 301-480-5158

Email: <ludlams@nhlbi.nih.gov>

Dr. Paula Einhorn

Division of Prevention and Population Sciences

6701 Rockledge Drive, Room 10222

Bethesda, MD 20892-7938

301-435-0563, Fax: 301-480-1773

Email: <einhornp@nhlbi.nih.gov>

For program information, contact:

Ms. Susan Pucie

National Heart, Lung, and Blood Institute

NHLBI SBIR/STTR Program Coordinator

6701 Rockledge Drive, Room 9138

Bethesda, MD 20892-7950

301-435-0079, Fax: 301-480-0867

Email: <sp34j@nih.gov>

For administrative and business management questions, contact:

Mr. Robert Vinson

National Heart, Lung, and Blood Institute

Office of Grants Management

6701 Rockledge Drive, Suite 7044

Bethesda, MD 20892-7926

301-435-0166, Fax: 301-451-5462

Email: <vinsonr@nhlbi.nih.gov>

[]{#__RefHeading___Toc219687144 .anchor}National Human Genome Research
Institute (NHGRI)

The successful completion of the HGP in 2003 set the stage for making
use of the immense potential inherent in knowledge of the complete DNA
sequence of the human genome to be applied for the improvement of human
health and well-being. In an effort to outline a path forward, the
Vision Document ([*Nature* 422,835-847
(2003)](http://www.genome.gov/Pages/About/vision.pdf)) broadly outlined
three areas that need to be addressed: (1) elucidating the structure and
function of genomes; (2) translating genome-based knowledge into health
benefits; and (3) promoting the use of genomics to maximize benefits and
minimize harms. The latter area relates closely to NHGRI's Ethical,
Legal and Social Implications (ELSI) Program. The research topics
encompassed by this area have traditionally been included in a separate
program announcement. However, given the growing interrelatedness of
genomics to research in humans and to applications in health care and
other settings, it has become increasingly clear that the investigation
of ELSI issues cannot be separated from the genomic research that
generates these issues. As a result, the ELSI research agenda is
described in this NHGRI-wide announcement, as well as in a separate
ELSI-specific Program Announcement
http://grants.nih.gov/grants/guide/pa-files/PA-08-012.html).

The purpose of this document is to provide information to investigators
about the breadth of NHGRI's research interests and is very similar the
Institute's general funding opportunity announcements
([http://grants.nih.gov/grants/
guide/pa-files/PA-07-458.html](http://grants.nih.gov/grants/guide/pa-files/PA-07-458.html)
and <http://grants.nih.gov/grants/guide/pa-files/PA-07-459.html>). When
appropriate, NHGRI will publish Requests for Applications that will be
used to stimulate research in specific areas, to fill gaps in research
knowledge, or to generate community resources that will further the
mission of genomics or ELSI research.

The following are areas of high interest for investigator-initiated
applications; they are not listed in priority order.

[]{#__RefHeading___Toc219687145 .anchor}Technology and Methods
Development

Technology development in DNA sequencing and genotyping are examples of
activities that have changed the nature of what scientific research
questions are practical to address, have enabled new approaches, and
have potentiated the development of new community resource data sets.
Many areas of critical importance to the realization of the
genomics-based vision for biomedical research require continued
technological and methodological developments before pilots and then
large-scale approaches can be attempted. Accordingly, the NHGRI will
continue to support the development of new, fundamental technologies in
all areas of genomics. Other important areas in which technology
development proposals would be responsive to this Program Announcement
include (but are not limited to) analyses of gene expression, discovery
and characterization of genetic variation; identification of the genetic
contributions to health, disease, and drug response; statistical
analytic methods for understanding human genomic variation and its
relationship to health and disease; and chemical genomics. There is also
continued interest in supporting technology development for the
comprehensive discovery of functional elements in the human and model
organism genomes, and new DNA sequencing technology.

The Institute is also interested in contributing selectively to the
development of new and needed technology in related areas, such as
proteomics and systems biology research, when NHGRI funding can be used
to further a truly unique development that will have a significant
impact on the field.

[]{#__RefHeading___Toc219687146 .anchor}Bioinformatics

Genome databases are essential resources for the biological and
biomedical research communities. The creation and maintenance of
effective databases are as important a component of research funding as
data generation. The NHGRI has been a primary source of support for
several major genetics/genomics-oriented databases and will continue to
foster technology improvements to develop effective methods for
integrating, displaying, and providing access to genomic information.
Projects addressing new database technologies to improve the utility of
genome databases would be appropriate as R01 applications. However,
NHGRI will not accept new applications for implementing and supporting
the production of databases without prior approval from program staff.

[]{#__RefHeading___Toc219687147 .anchor}Computational Biology

The NHGRI has supported the generation of many large-scale genomic data
sets such as genome sequence, haplotype maps, transcriptome
measurements, protein interactions, and functional elements. NHGRI
encourages the development of new computational methods and tools to
analyze these and other large datasets, and to extract useful biological
information from them. Where possible, existing community data standards
and methods for data exchange should be used in the development of these
new methods and tools. Further information on programs related to
genomic databases and computational biology is available at this
website: <http://www.genome.gov/10001735>.

The development of new sequencing technologies has dramatically
increased the amount of data produced for genomics. NHGRI is interested
in supporting new computational applications for the production and
analysis of data from these new sequencing platforms. These applications
would include better computational methods for storage, compression and
transfer of large datasets by biomedical researchers along with better
analysis methods to interpret these data and integrate with other data
types.

[]{#__RefHeading___Toc219687148 .anchor}Population Genomics

This is an emerging discipline that applies genomic technologies, such
as genome-wide association testing and sequencing, to population studies
to identify gene regions, genes, or variants affecting common
etiologically complex conditions and predict individual risk. It also
investigates the value of applying genomic methods in clinical care for
the diagnosis, treatment, and prevention of complex diseases. The
research scope of Population Genomics at NHGRI includes: developing
resources and statistical methods for observational studies and clinical
trials incorporating advanced genomic technologies; conducting
proof-of-principle studies that apply genomic technologies to particular
conditions that can be generalized to a broader range of conditions
(e.g., translating genomic information to clinical care); and developing
research methods and infrastructure needed for future epidemiologic
studies of genetic and environmental contribution to disease in the
United States, including a large, prospective cohort study of genes and
environment. For additional information about Population Genomics within
NHGRI, please visit this website: <http://www.genome.gov/19518660>.

[]{#__RefHeading___Toc219687149 .anchor}Ethical, Legal and Social
Implications

NHGRI supportsNumber range CHAPTER studies that examine issues and,
where appropriate, develop policy options in the following areas: 1) the
translation of genomic information to improved human health; 2) the
conduct of genomic research---particularly genome-wide association
studies, medical sequencing and clinical studies; 3) intellectual
property issues surrounding access to and use of genomic information; 4)
the use of genomic information and technologies in non-health care
settings; 5) the impact of genomics on concepts of race, ethnicity,
kinship and individual and group identity; 6) the implications, for both
individuals and society, of uncovering genetic contributions not only to
disease but also to \'normal\' human traits and behaviors; and 7) how
different individuals, cultures, and religious traditions view the
ethical boundaries for the uses of genetics and genomics. Several of
these topics are closely integrated with genomic research, which is why
they are described here.

[]{#__RefHeading___Toc219687150 .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___Toc219687151 .anchor}National Institute of Mental
Health (NIMH)

The mission of the National Institute of Mental Health (NIMH) is to
transform the understanding and treatment of mental illnesses through
basic and clinical research, paving the way for prevention, recovery,
and cure. Mental disorders constitute an immense burden on the U.S.
population, with major depression now the leading cause of disability in
the U.S., and schizophrenia, bipolar disorder, and obsessive-compulsive
disorder ranked among the ten leading causes of disability. NIMH also
takes a leading role in understanding the impact of behavior on HIV
transmission and pathogenesis, and in developing effective behavioral
preventive interventions. The NIMH conducts a wide range of research,
research training, research capacity development, as well as public
information outreach and dissemination to fulfill its mission.

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___Toc219687152 .anchor}NIMH-Supported Program
Announcements:

1\. Lab to Marketplace: Tools for Brain and Behavioral Research (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-08-071.html> (SBIR)

2\. Competing Renewal Awards of SBIR Phase II Grants for Brain and
Behavior Tools (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-08-056.html> (SBIR)

3\. Innovations in Biomedical Computational Science and Technology:
SBIR/STTR Initiative\
<http://grants.nih.gov/grants/guide/pa-files/PAR-06-535.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PAR-06-534.html> (STTR)

4\. Development of PET and SPECT ligands for brain imaging\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-017.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-018.html> (STTR)

5\. Pharmacologic Agents and Drugs for Mental Disorders\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-027.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-028.html> (STTR).

6\. Development of Biomarkers for Mental Health Research and Clinical
Utilities\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-016.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-015.html> (STTR)

7\. Probes for Microimaging the Nervous System\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-021.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-022.html> (STTR).

8\. Integration of Heterogeneous Data Sources\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-011.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-010.html> (STTR).

9\. High Throughput Tools for Brain and Behavior\
<http://grants.nih.gov/grants/guide/pa-files/PA-08-001.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-08-002.html> (STTR).

10\. Bioengineering Nanotechnology Initiative\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-008.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-009.html> (STTR).

11\. Novel Tools for Investigating Brain-derived GPCRs in Mental Health
Research\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-375.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-374.html> (STTR)

12\. Tools to Mitigate and Understand the Mental Health Effects of
National Disasters\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-335.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-336.html> (STTR)

13\. Small Business Innovation Research to Improve the Chemistry and
Targeted Delivery of RNAi Molecules\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-003.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-004.html> (STTR)

14\. New Technology for Proteomics and Glycomics\
<http://grants.nih.gov/grants/guide/pa-files/PA-07-451.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-07-452.html> (STTR)

15\. Manufacturing Processes of Medical, Dental, and Biological
Technologies\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-013.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-012.html> (STTR)

16\. Therapeutics Development for HIV/AIDS-Associated Neuropsychological
Disorders\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-432.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-06-433.html> (STTR)

17\. Computational Tools for Research in Neuroscience, Behavioral
Science and Mental Health\
<http://grants.nih.gov/grants/guide/pa-files/PA-07-424.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-07-423.html> (STTR)

18\. Neurotechnology Research, Development, and Enhancement\
<http://grants.nih.gov/grants/guide/pa-files/PA-07-389.html> (SBIR)\
<http://grants.nih.gov/grants/guide/pa-files/PA-07-390.html> (STTR)

19\. Technology for the Detection and Characterization of Low Abundance
Proteins, Peptides, or micro RNAs\
<http://grants.nih.gov/grants/guide/pa-files/PAS-07-241.html>

[]{#__RefHeading___Toc219687153 .anchor}Phase II Competing Renewal
Awards

(See <http://grants.nih.gov/grants/guide/pa-files/PA-06-079.html> and
Notice
<http://grants.nih.gov/grants/guide/notice-files/NOT-MH-07-118.html>, as
well as Notice
<http://grants.nih.gov/grants/guide/notice-files/NOT-MH-07-116.html>.)

The NIMH will accept Phase II SBIR Competing Renewal grant applications
in two categories: 1) to continue research and development of
technologies that ultimately require federal regulatory approval (see
below and see funding opportunity announcement PA-06-079, entitled
"Competing Renewal Awards of SBIR Phase II Grants for Pharmacologic
Agents and Drugs for Mental Disorders (SBIR R43/R44)"
<http://grants.nih.gov/grants/guide/pa-files/PA-06-079.html>, and 2) to
continue research and development of complex instrumentation, clinical
research tools, or behavioral interventions and treatment s(see below
and see funding opportunity announcement PA-08-056, entitled "Competing
Renewal Awards of SBIR Phase II Grants for Brain and Behavior Tools
(R44)" <http://grants.nih.gov/grants/guide/pa-files/PA-08-056.html>.

Technologies in the former category (those that ultimately require
federal regulatory approval) include, but are not limited to:
pharmacologic agents and drugs, biological products, medical devices,
vaccines, etc., related to the mission of the NIMH. Phase II SBIR
Competing Renewal grants for such technologies should allow small
businesses to get research and development to a stage where interest and
investment by third parties is more likely. Companies engaging in drug
development for the treatment of mental health disorders may be eligible
to submit competing renewal applications through the specific funding
opportunity announcement PA-06-079, entitled "Competing Renewal Awards
of SBIR Phase II Grants for Pharmacologic Agents and Drugs for Mental
Disorders (SBIR R43/R44)"
<http://grants.nih.gov/grants/guide/pa-files/PA-06-079.html>. For this
specific opportunity, budgets up to \$1.0 million total costs per year
and time periods up to three years may be requested.

Companies that are developing technologies that do not focus on drug
development, but that require federal regulatory approval prior to
commercialization, may be eligible to submit a competing renewal
application through the standard SBIR funding opportunity announcement.
For this opportunity, budget limits of up to \$800,000 total costs per
year and time periods up to 3 years may be requested.

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-09-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.

Although technologies in the latter category (complex instrumentation,
clinical research tools, or behavioral interventions/treatments) may not
require federal regulatory approval, extraordinary time and effort is
needed for their research and development. Therefore, NIMH now supports
competing renewal awards of existing Phase II grants for such
technologies. The competing renewal award for these would provide up to
an additional three years of support at total cost funding levels of up
to \$800,000 per year. Applicants should apply through the funding
opportunity announcement PA-08-056, entitled "Competing Renewal Awards
of SBIR Phase II Grants for Brain and Behavior Tools (R44)"
<http://grants.nih.gov/grants/guide/pa-files/PA-08-056.html>.

Direct your questions about scientific/research issues to:

Margaret Grabb, Ph.D.

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___Toc219687154 .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 for stimulation
and/or recording, smart nanoscaffolds, macroelectrodes, biocompatible
coatings, interfaces to electronics, software for data analysis,
visualization, etc.

2\. *[Cell Sorting]{.underline}*. Based on cell size, type, function,
morphology, abnormal features, specific membrane proteins, 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\. Development of novel technologies for simultaneous recording of
circuits.

8\. Development of more sensitive fluorescent probes for simultaneous
and real time measures of multiple neurotransmitter release.

9\. *[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 and/or activity 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 drug and/or 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\. Development of selective hormone receptor ligands for brain imaging.

6\. Development of imaging agents to examine the integrity of the blood
brain barrier following infection and other environmental challenges.

7\. 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.

8\. 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).

9\. Methods and associated products for quantitation of imaging data
including new statistical approaches for evaluating the data.

10\. Methods to integrate routines for greater and more precise computer
enhancement of the images, and for combining or overlaying images
obtained from multiple modalities.

11\. 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.

12\. 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.

13\. Generation of physiologic measurements from images of regional
radioactivity generated during PET, especially for the study of brain
neurotransmitter/neuroreceptor systems.

14\. Novel approaches to visualizing data obtained in neuroimaging, such
as the computational "unfolding" of three-dimensional images of cerebral
cortex.

15\. 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.

16\. Combining of different imaging technologies (e.g., ERPs and fMRI;
MEG and fMRI; MEG and EEG, etc).

17\. New tools and devices to simultaneously record hemodynamic signals
(BOLD, rCBF, etc.) and neural activity (EEG, LFP, spiking, etc.) to
better understand the direct relationship between blood flow variables
and neural activity within the brain.

18\. 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.

19\. 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.

20\. Improvements in TMS techniques that will allow for greater
specificity in the sites of stimulation and greater control over the
effects of the stimulation. In particular, improvements in stimulators
that would allow much smaller effective fields of stimulation with more
reliable and repeatable stimulator placement would be a significant
benefit to the field.

21\. Real time fMRI is becoming a research tool of interest with
potential clinical/therapeutic neurofeedback applications. Products are
needed that would enhance the ability of scientists to use this
technology for those neurofeedback applications in an off-the-shelf
manner.

22\. Development of methods to improve efficiency of viruses used in
primate track tracing studies.

23\. Development of more sophisticated imaging strategies in rodents.

24\. Development of a user-friendly interface to serial reconstruction
software capable of generating stackable, 3D images of axonal and
dendritic arborizations at the light and electron microscopic level.

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\. Develop tools to facilitate proteomic analysis of CNS neurons.

12\. Develop tools to facilitate in vivo studies of protein-protein
interaction, folding and aggregation. These technologies could impact
our understanding of the basic neurotransmitter receptors chemistry and
on developing of more selective small chemical entities with high
affinities for CNS targets.

13\. New approaches to study the multiple functions of particular
proteins.

14\. Tools to study post-translational changes in proteins (expression
levels, post-translational modifications, etc.) in specified tissue
compartments and subcellular domains.

15\. Technologies to study functional entities within cells (e.g., green
fluorescent protein approaches) and subcellular compartments.

16\. Tools and approaches to study coordinate changes in genes and their
functional relationship to phenotypes, including phenotypes associated
with specific brain disorders.

17\. Develop novel markers for elucidating how signaling cascades impact
DNA transcription.

18\. 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).

19\. 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.

20\. Develop novel techniques for isolating and identifying the
structure of brain-derived membrane proteins.

21\. New methods to identify peptide receptors for which traditional
biochemical approaches (e.g.: radiolabeling techniques) failed to
produce results. This would be relevant for the development of small
molecular probes that would target peptide systems that might be altered
in mental disorders.

22\. New approaches to facilitate faster and more reliable screening of
novel genes and gene products that may be up or down regulated due to
the administration of pharmacological therapies for mental disorders
(e.g.: antipsychotics and antidepressants).

23\. Development of new and optimization of the existing methods for
non-invasive quantitative detection of hormones in awake behaving
animals.

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
synthetic nucleic acids to manipulate endogenous gene expression in
specific cell populations and/or brain regions.

5\. Develop standardized behavioral tests to assess the gene knockouts
and/or gene "knockins" affecting neurotransmission.

6\. New approaches for spatially and/or temporally restricted gene
activation and/or inactivation.

7\. Develop new technologies to study gene function and expression,
including approaches to studying gene and protein expression at single
cell resolution.

8\. Develop novel approaches to study the expression characteristics of
non-coding (nc) RNA molecules as well as developing methodologies using
nc-RNAs to manipulate gene expression in cells and tissues of the
nervous system.

9\. Development of embryonic stem (ES) cell lines from rodent strains
(rats and mice) of relevance to behavioral research.

10\. Development of technologies and approaches to facilitate the
collection and distribution of ES cell lines containing mutations of
potential relevance to behavioral research.

11\. Develop methods for long-term storage of transgenic germ cell
lines.

12\. Develop technologies and approaches to aid in the renewal of
founder colonies of transgenic mice from repositories of transgenic germ
cell lines.

13\. 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.

14\. Develop gene transfer technologies such as viral vectors and
non-viral (e.g. polymer-based) systems to produce long-term, stable gene
expression in the brain.

15\. Develop methods to analyze and manipulate DNA structure to study
epigenetic modifications and chromatin remodeling in brain tissue and
neuronal populations.

16\. Development of selective gene silencing strategies to ablate
neurons in one circuitry in order to examine its specific behavioral
consequences.

17\. Technology development in epigenetics:\
a) development of novel and highly accurate tools to analyze proteomics
of histones\
b) development of antibodies for immunochemical studies of histone
modifications that selectively target a specific DNA modification site.

18\. Technology development in Microbiome research: a) development of
tools for high throughput genomic analysis of human microbiome; b)
development of informatics tools to study the huge amount data that will
result from these studies; and c) development of methods to determine
the interaction between microbial community genes and host genetics as a
potential contributing factor for mental disorders.

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.

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, and
neuroimaging agents.

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 CNS
targets. Examples include, but are not limited to, receptors,
transporters, ion channels, enzymes, kinases, or second or third
messenger systems.

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) within specific domains of
cognitive function.

7\. Behavioral "models" similar in animals and humans; behavioral
pharmacological effects that may serve as "surrogate" markers in humans.

8\. Development of models for evaluating drug effects within functional
brain circuits relevant to mental disorders.

9\. Development of novel drug delivery systems.

10\. Tools for Drug Development including neuroimaging (e.g.,
radiolabeled compounds) and development of animal models.

11\. Pharmacological profiling (in vitro and in vivo) for potential
therapeutic drugs.

12\. 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.

13\. Improving existing, and developing new, vectors for delivery of
genes to the brain.

14\. Development of novel therapeutic approaches based on drug-induced
changes in gene promoter activity.

15\. 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.

16\. 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\. Better portable sleep monitoring devices to enhance studies of
sleep in human subjects, for use in basic research and/or clinical labs.

v\. 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. An example would be the
development of a web-based database for sharing, analyzing and comparing
the pharmacological responses of a variety of CNS active compounds in
preclinical studies relevant to mental health.

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.

For further information on basic neuroscience or basic behavioral
science research topics, contact:

Margaret Grabb, Ph.D.

Chief, SBIR/STTR Program

National Institute of Mental Health

6001 Executive Blvd. Room 7201

Mail Stop Code 9645

Bethesda, MD 20892

301-443-3563, Fax: 301-443-1731

Email: <mgrabb@mail.nih.gov>

[]{#__RefHeading___Toc219687155 .anchor}The Division of Developmental
Translational Research

The Division of Developmental Translational Research 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.

5\. *[Development and maintenance of clinical trial
networks.]{.underline}* Areas include the development of
hardware/software to facilitate research collaborations in conducting
clinical trials, technologies to facilitate data sharing, merging of
multiple data sets, and the development and maintenance of common
protocols across research sites working on a common pediatric preventive
or treatment intervention.

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 Developmental Translational Research-related
topics, contact:

Margaret Grabb, Ph.D.

Chief, SBIR/STTR Program

National Institute of Mental Health

6001 Executive Blvd. Room 7201

Mail Stop Code 9645

Bethesda, MD 20892

301-443-3563, Fax: 301-443-1731

Email: <mgrabb@mail.nih.gov>

[]{#__RefHeading___Toc219687156 .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. This division
also includes a program on Traumatic Stress Disorders Research. 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 and resource development in the etiology, pathophysiology and
course of mental disorders of late life as well as in the treatment and
rehabilitation of persons with these disorders. Disorders studied
include mood, anxiety and personality disorders, psychotic disorders and
schizophrenia, psychiatric syndromes and behavioral disorders in
Alzheimer's disease and related dementias, suicide, sleep disorders and
eating disorders. Selected areas of emphasis include: development of
more reliable and valid phenotypes, assessments and biological and
behavioral markers for late-life mental disorders; development of
improved treatment and preventive intervention techniques for use in
geriatric care settings; and identification of genetic, brain imaging
and other predictors of variability in older adults' treatment response.

***[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.

***[Traumatic Stress Disorders Research Program.]{.underline}*** This
program is the DATR/NIMH point of contact for
disaster/terrorism/biodefense-related research. The program supports
research on biopsychosocial risk/protective factors for psychopathology
after traumatic events and the development of interventions for PTSD in
adults; and research spanning and integrating basic science, clinical
practice, and health care system factors regarding mass trauma and
violence (e.g. war, terrorism, natural and technological disaster),
including interventions and service delivery targeting an array of
relevant mental health concerns (distress, disorder, functional
sequelae) in children, adolescents, and adults.

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.

f\. Innovative technologies for identifying and directing clinical
attention to potentially adverse psychotropic drug interactions,
particularly in vulnerable patients with complex regimens involving
multiple medications.

g\. Simple-to-use tools for assessing individual risk profiles for the
development of various mental disorders.

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 trials.

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:

Margaret Grabb, Ph.D.

Chief, SBIR/STTR Program

National Institute of Mental Health

6001 Executive Blvd. Room 7201

Mail Stop Code 9645

Bethesda, MD 20892

301-443-3563, Fax: 301-443-1731

Email: <mgrabb@mail.nih.gov>

[]{#__RefHeading___Toc219687157 .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, including but not limited
to research associated with HIV/AIDS. Two main research components make
up this division: The Center for Mental Health Research on AIDS and the
Health and Behavior Research Branch. Specific topics related to these
two research areas are listed below. Inquiries are encouraged.

The Center for Mental Health Research on AIDS:

A. ***[Technologies to Facilitate Research in HIV/AIDS Prevention and
Care]{.underline}***

1\. Innovative approaches for assessing HIV sexual risk behavior among
research participants and at-risk populations, including biomarkers of
risk behavior.

2\. Development of electronic, on-line archives of validated HIV/AIDS
research instruments.

3\. Development and validation of novel self-report, computer-assisted,
and virtual reality HIV/AIDS research instruments and assessments.

4\. Development of methods to assess functioning in families in which
there is an HIV infection in order to develop improved treatment
modalities.

5\. New tools and methods that physicians and researchers could use to
monitor patient adherence to prescribed HIV/AIDS antiretroviral
medication regimen in real time.

6\. Computational systems that physicians and researchers can use to
model the development of drug resistance based on degree of patient
adherence to HIV/AIDS antiretroviral medications.

7\. Technologies to assist the merging of multiple forms of HIV/AIDS
data sets (e.g., community- or clinic-level data, pharmacy claims,
patient self-reports, etc.) and to facilitate innovative and complex
analytic strategies.

8\. Causal modeling methodology as applied to correlational longitudinal
data sets collected in HIV/AIDS research.

9\. The development and advancement of innovative research trial designs
(e.g., fixed adaptive, encouragement, partially randomized preference)
for HIV/AIDS prevention and care research.

10\. Technology and electronic systems that will facilitate participant
scheduling, tracking, and retention in HIV/AIDS clinical trials and
longitudinal studies.

11\. The application of modern technology to enhance the science,
operation, and management of multi-site HIV/AIDS clinical trials and
behavioral research.

12\. A data translation and communication package for collecting,
archiving, and making available existing HIV/AIDS behavioral data sets
to the scientific community for secondary or meta-analyses.

B. ***[HIV Prevention Interventions.]{.underline}*** CMHRA seeks
innovative technologies and strategies that will help reduce HIV
transmission risk behavior, especially among populations at high risk
for HIV infection (such as ethnic minority populations and young
men-who-have-sex with men), as well as among individuals who are
infected with HIV.

1\. Development of methods to reduce, prevent and/or change
HIV-associated and STD risk behaviors.

2\. Development of school-based HIV prevention curricula, including
innovative uses of emerging technologies.

3\. Curricula, computer software and virtual reality programs that
provide communication skills, training and role-play exercises for HIV
risk reduction.

4\. Methods to increase use of HIV testing and that facilitate effective
test result obtainment, confirmation and counseling.

5\. Novel approaches to address the issue of relapse prevention of
HIV-associated risk behaviors.

6\. Development of new behavioral strategies to reduce high-risk HIV
transmission behavior among persons recently infected.

C. ***[HIV/AIDS Educational Tools, Curricula, and Scientific
Training]{.underline}***

1\. Development of computer-based or online HIV/AIDS prevention
curricula and interventions for parents, foster parents and guardians,
schools, or community settings.

2\. Research on the best ways to present HIV/AIDS science and prevention
information in an age-appropriate manner to particular groups of
students.

3\. Development of print and/or computer based materials to assist
primary care practitioners in informing their patients about HIV risk
and prevention.

4\. Innovative approaches to the development of curricula for training
in multicultural issues and development of cultural competence in HIV
risk assessment.

5\. Develop and test technologies designed to modify the practice
behaviors and decision-making process of health care providers to
improve the quality of screening, counseling, prevention, and treatment
services for HIV positive persons or individuals at-risk for HIV.

6\. Video and computer-assisted methods to train health and mental
health care providers in the psychosocial and neuropsychiatric aspects
of HIV infection and AIDS.

7\. Development of materials and programs to assist health care
practitioners in improving patient adherence to HIV/AIDS medical
regimens.

8\. Development of training materials to increase awareness regarding
the neurodevelopmental consequences of HIV infection in children in
developing countries.

9\. Development of strategies and systems to encourage entry and
retention of individuals with non-HIV/AIDS science backgrounds
(engineers, computer scientists, medical anthropologists, law, business)
or perspectives (individuals from under-represented communities) into
the HIV/AIDS research field.

10\. Development of systems to keep established researchers and
practitioners up-to-date on the findings and implementation of HIV
research.

D. ***[Systems to Advance the Dissemination and Implementation of
HIV/AIDS Interventions]{.underline}***

1\. Web-based networks and software for the dissemination,
identification, and tailoring of efficacious HIV/AIDS behavioral
interventions targeting at-risk populations.

2\. Development of technological approaches to increase the sustainable
uptake of scientifically based HIV/AIDS prevention interventions across
diverse community settings.

3\. Development of strategies or application of technology to assist
organizations in identifying and implementing proven HIV prevention
strategies and in addressing health disparities.

4\. Novel methods of disseminating HIV prevention materials to be used
in community based outreach programs for special populations (school
dropouts, homeless, street youth, incarcerated youth).

5\. Development of innovative approaches to link researchers with
community providers in the implementation of research-based HIV
prevention efforts at the community level.

6\. Systems that build the capacity of HIV/AIDS community-based
organizations to conduct program evaluations and document intervention
outcomes for the purposes of maintaining and enhancing ongoing
intervention programs.

E. ***[Technologies to Support HIV/AIDS Mental Health
Services]{.underline}***

1\. Use of technology to develop and disseminate curricula for training
clinicians and other health care practitioners in the prevention and
treatment of HIV-related mental disorders.

2\. Development of novel programs to help people recognize and access
treatment of mental health problems arising from living with HIV/AIDS as
a long-term chronic condition.

3\. Develop rehabilitative approaches to alleviate HIV-associated
neurodevelopmental abnormalities that may restrict children's academic
achievements and quality of life.

4\. Development of innovative approaches to reduce stigma often
expressed toward individuals with HIV/AIDS.

5\. Develop and test interventions for appropriate HIV status disclosure
to relationship partners, family members, and health care providers, in
an effort to optimizes the likelihood of positive outcomes.

F. ***[Tools to Monitor and Improve Patient Adherence to HIV/AIDS
Treatment]{.underline}***

1\. Development of novel methods to expedite and enhance linkage to
primary medical care for individuals who receive HIV-seropositive test
results in community-based settings.

2\. Technologies that will electronically monitor HIV/AIDS patient
adherence to antiretroviral medications and that will use wireless
technology to radio this data back to providers and/or researchers for
real-time monitoring of adherence.

3\. Clinic-based systems that will screen HIV/AIDS patients for
medication adherence while they await medical appointments and that will
immediately integrate these patient reports into the electronic medical
record so this information is routinely available to physicians during
their appointments with patients.

4\. Development of novel tools or methodologies designed to improve
patient adherence to HIV/AIDS drug therapies.

5\. Systems that improve adherence to HIV/AIDS medical care by enhancing
the ability of patients to monitor and manage scheduled medical
appointments, routine prescription refills, and daily medication doses.

6\. Novel systems for distributing, dispensing, or administering
antiretroviral drugs that are designed to enhance patient adherence to
these regimens.

7\. Biologically-based technologies that will aid medical doctors in
determining how a particular individual may respond to a particular
HIV/AIDS 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.

G. ***[Research Tools and Treatments for 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: nanotechnologies, 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\. Discovery and development of novel tools and cost effective methods
for detecting the efficacy and neurological and neuropsychiatric side
effects of anti-retroviral medications.

8\. New approaches to reduce transmission risk or neuro-cognitive
impairment in persons with recent HIV infection (0-6 months post
exposure).

9\. Novel therapeutic and diagnostic instrumentation development for the
detection and treatment of neurological manifestations of HIV
co-infections such as tuberculosis, hepatitis C, toxoplasmosis, that can
be used in developing countries.

10\. Development of novel or refinement of existing cell-based assays
designed to screen compounds (small molecule, large molecule,
bioproduct, etc.) targeted to treat neurologic and psychiatric disorders
that are associated with HIV/AIDS.

11\. Development of novel or refinement of existing animal models to
test the efficacy and toxicity of new agents targeted specifically
towards eliminating/eradicating HIV or its sequelae in the brain.

12\. Discovery and development of small molecular inhibitors or
enhancers targeted to mechanisms that play critical roles in viral
replication pathways especially in the CNS.

13\. Improvement/validation/characterization of the existing in vitro
and animal models that are used for screening compounds that have
therapeutic potential for NeuroAIDS and its associated complications.

14\. Novel compounds or adjunctive therapies that have the potential to
protect/ameliorate/treat the long-term neurologic and psychiatric side
effects of ARVs in the presence or absence of psychotropic medications.

15\. Novel models or methods for the pharmacokinetic/pharmacodynamic
studies to detect long-term neuropsychological adverse effects of ARVs.

16\. Applications that assess the neuroprotective potential or
inhibition of HIV replication in the brain with FDA-approved drugs that
are currently registered for other indications (off-label validation
studies).

17\. Development/improvement of cost effective methods, assays, or
instruments that detect currently approved ARVs plasma concentrations in
relationship with disease progression.

18\. Discovery and development of biomarkers designed to detect drug
efficacy, measure viral load, or provide evidence that agents are
directed against the targets in the CNS or peripheral nervous system
(PNS).

19\. Development of technology (IT or other) to optimally
study/analyze/report on adverse effects of ARVs in the presence of other
medications, especially psychotropic medications, drugs of abuse, or
medications to treat drug abuse.

20\. Develop or adapt neurological/ neuropsychological/neurobehavioral
assessments to evaluate HIV associated abnormalities in adults/children
in resource poor environments that are adaptable to different cultures
and languages.

For information related to programs supported by the Center for Mental
Health Research on AIDS please contact:

Michael J. Stirratt, Ph.D.

Program Officer, Adherence Program and SBIR/STTR Programs

Center for Mental Health Research on AIDS

Division of AIDS and Health and Behavior Research

National Institute of Mental Health

6001 Executive Blvd., Room 6199

Bethesda, MD 20892 (Postal mail)

Rockville, MD 20852 (FedEx, UPS)

Telephone: 301-443-6802

Fax: 301-443-9719

E-mail: <stirrattm@mail.nih.gov>

Health and Behavior Research:

The Health and Behavior Research Branch supports research on a range of
health behaviors in people with mental disorders. Research is supported
on identifying potent, modifiable risk and protective factors for mental
disorders that may guide the development and initial testing of
theory-driven interventions. Interventions may be prevention, treatment,
or rehabilitation and include biological, pharmacological, behavioral,
psychosocial, or environmental components. Research is supported on
co-morbid mental and other physical disorders, adherence to
interventions for mental disorders, ethics in mental disorders research,
mental disorders stigma and discrimination, mental health disparities,
health behavior change in people with mental disorders, and functional
assessment in people with mental disorders. Areas of interest for
SBIR/STTR applications include:

A. ***[Treatment Adherence Research Program.]{.underline}***

1\. Innovative methods to assess medication adherence including
biotracers or biochemical markers of medication use, automated
assessment of actual pill taking, and improvements over current
medication use tracking systems.

2\. Development of low-cost, easily adopted medication tracking and
monitoring systems for use in clinical practice.

3\. Innovative and reliable methods for measuring adherence to
psychosocial interventions including session attendance, engagement
during sessions, and homework assignments between sessions.

4\. Statistical approaches and software specifically designed to analyze
patterns of adherence.

B. ***[Behavior Change Research Program.]{.underline}***

1\. Development of computerized systems for screening, assessing,
tracking, and managing health risk factors (e.g. smoking, diet,
exercise) in mental health treatment programs.

2\. Computerized care management systems to encourage mental health
practitioners to follow metabolic syndrome treatment guidelines related
to the atypical antipsychotic medications.

3\. Development and evaluation of novel methods for assessing diet and
physical activity in those with severe mental illness and cognitive
deficits that may limit the validity of traditional approaches (e.g. 24
hr. recall, food diaries, activity recall, activity logs).

C. ***[Comorbidity Research Program.]{.underline}***

1\. Computerized care management programs to assist primary care
physicians with detecting and treating mental disorders in those with
comorbid physical disorders.

2\. Development of low-cost, easily adopted screening programs for the
presence of mental disorders among those presenting in primary care
clinics.

D. ***[Functional Assessment and Mental Disorders
Program.]{.underline}***

1\. Automated methods for assessing functional capacity and performance
in those with mental disorders.

2\. Development of innovative and automated methods for assessing social
skills and interactions of those with mental disorders.

3\. Development of a home-based lithium blood level test for the
monitoring/maintenance of lithium treatment in patients with bipolar
disorder, and for the real-time transfer of results to the physician\'s
office.

E. ***[Stigma and Health Disparities Program.]{.underline}***

1\. Development of innovative public service announcements to reduce
stigma and promote seeking of mental health care, particularly among
minority and underserved populations.

2\. Multimedia educational programs for schools, workplaces, or other
venues to address mental health stigma and to encourage seeking mental
health care, particularly among minority and underserved populations.

For information related to programs supported by the Health and Behavior
Research Branch please contact:

William Riley, Ph.D.

Deputy Director, Division of AIDS and Health and Behavior Research

National Institute of Mental Health

6001 Executive Blvd. Room 6219

MSC 9619

Bethesda, MD 20892

301-435-0301, Fax: 301-443-6000

Email: <wiriley@mail.nih.gov>

[]{#__RefHeading___Toc219687158 .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 composed of three branches: Services
Research and Clinical Epidemiology Branch, Adult 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.

The priorities for 2008 should focus on technologies that advance the
scientific opportunities and recommendations of ["The Road Ahead:
Research Partnerships to Transform Services, A Report by the National
Advisory Mental Health Council's Workgroups on Services and Clinical
Epidemiology
Research."](http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/road-ahead.pdf)
"The Road Ahead: Research Partnerships to Transform Services, A Report
by the National Advisory Mental Health Council's Workgroups on Services
and Clinical Epidemiology Research," and the NIMH Strategic Plan.
Examples are listed below:

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. The development of portable clinical trial management
systems such as serious adverse event (SAE) oversight and monitoring
software. Adaptation of existing clinical trial methodologies to study
mental health disorders. Development of common data elements to enhance
uniformity across clinical trials with and amongst disorders.

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).
Development of technology to enhance conduct of clinical trials and the
dissemination of their results.

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: 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.

8\. **Computerized Methodologies for Mental Health Services Research:**
Applications need to focus on computerized methods to assess mental
disorders in primary care settings including screening devices for
identifying mental disorders across the life-span; development of
computer software and hardware that allow conducting computer assisted
interviews with severely mentally ill people for research purposes to
obtain information on their quality of care; design work to move
assessment as rapidly as possible to computerized adaptive testing
(CAT); apply audio and video technologies to assess patient's treatment
preferences.

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.

D. ***[Clinical Trials Operations and Biostatistics
Unit.]{.underline}*** This Unit serves as the operations focal point for
collaborative clinical trials on mental disorders in adults and
children. The Unit has responsibility for operations and oversight of
both contract-supported and cooperative agreement-supported multisite
clinical trial protocols, as well as operations focus on special
clinical trial research projects that may be undertaken by the
Institute. In addition, the Unit has general leadership responsibility
for over-arching matters related to clinical trials operations, such as
the coordination of the ancillary protocols across the large trials,
development of long-term strategies for clinical trials research (such
as clinical trials research networks), improvement of the quality of
clinical trials by development and monitoring of operations guidelines,
and implementing the NIMH policy for dissemination of public access
datasets. Unit staff serves as primary liaison with the Data and Safety
Monitoring Boards for all matters related to the operation and conduct
of the clinical trials. The Unit provides consultation to Institute
staff and grantee/contractor staff on biostatistical matters related to
appropriateness of study design, determination of power and sample size,
and approaches to statistical analysis of data from clinical trials
supported by NIMH.

For further information on Services and Intervention Research contact:

Adam Haim

Division of Services and Intervention Research

6001 Executive Boulevard

Room 7160, MSC 9649

Bethesda, MD 20892-9635

301-445-3593

Email: <haima@mail.nih.gov>

[]{#__RefHeading___Toc219687159 .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.

Limited Amount of Award (Total not Annual)

For budgetary or programmatic reasons, NINDS may decrease the length of
an award, the amount of an award recommended by a review committee, or
not fund an application. Generally, NINDS does not fund Phase I
applications greater than \$350,000 total cost per year for up to 2
years or Phase II applications greater than \$750,000 total cost per
year for up to 3 years. Applicants considering a requested budget
greater than these limits are strongly encouraged to contact program
staff before submitting an application.

[]{#__RefHeading___Toc219687160 .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. Appropriate areas of effort may include the
following (but are not limited to): medicinal chemistry
structure-activity relationship (SAR) studies to develop drug
candidates, pharmacology studies aimed at evaluating the potential
therapeutic activity and side effect profile of drug candidates, and
their efficacy following chronic dosage; medicinal chemistry and
pharmacology studies aimed at synthesizing and evaluating compounds as
potential drug leads and as preclinical drug candidates; and studies
aimed at evaluating drug metabolism and pharmacokinetic behavior in
rodents. These efforts should extend 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\. Safety and effectiveness studies of novel medical devices.

4\. Human clinical trials/studies to determine the safety profile,
metabolism, and/or efficacy of a drug.

Please contact Dr. Randall Stewart (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-09-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.

For more information on Competing Renewal Awards of SBIR Phase II grants
for Brain and Behavior Tools:

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>

General Research Topics of Interest to NINDS

[]{#__RefHeading___Toc219687161 .anchor}Translational Research

NINDS defines translational research as the process of applying ideas,
insights, and discoveries generated through basic scientific inquiry to
the treatment or prevention of human disease. The NINDS Cooperative
Program encourages Phase II and Fast-Track applications that directly
address the identification and pre-clinical testing of new therapeutics
for neurological disorders. The program will facilitate solicitation,
development, and review of therapy-directed projects to accelerate the
translation of basic research discoveries into therapeutic candidates
for clinical testing. This program is specifically directed at projects
that include therapeutic leads with demonstrated activity against the
intended disease target. The program supports pre-clinical optimization
and testing of these leads and projects must be sufficiently advanced
that an IND or IDE application to the FDA can be submitted by the end of
the project period. The program does not support early-stage therapeutic
discovery activities such as high throughput screening. The program also
excludes clinical research, basic research, and studies of disease
mechanism. This is a milestone-driven cooperative agreement program
involving participation of NINDS staff in the development of the project
plan and monitoring of research progress.

For more information on the NINDS Cooperative Program in Translational
Research-Small Business Awards (SBIR\[U44\]):
<http://grants.nih.gov/grants/guide/pa-files/PAR-08-235.html>.

Due to the unique requirements of the NINDS Cooperative Program in
Translational Research, applicants are strongly encouraged to consult
with NINDS Program Staff at least three months prior to the next receipt
date.

Randall R. Stewart, Ph.D.

National Institute of Neurological Disorders and Stroke

301-496-1917

Email: <stewartr@ninds.nih.gov>

[]{#__RefHeading___Toc219687162 .anchor}Countermeasures Against Chemical
Threats

Research and development on new and improved therapeutics or diagnostic
technologies to prevent or mitigate the toxic effects from exposure to
chemical threats, defined as toxic chemical agents that could be used in
a terrorist attack against civilians, or those that could be released at
toxic levels by accident or natural disaster. This includes the
development of new (or support of existing) partnerships between small
business and not-for-profit laboratories engaged in this research. For
more information on this program <http://www.ninds.nih.gov/counteract>.

David Jett, Ph.D.

National Institute of Neurological Disorders and Stroke

301-496-6035

Email: <jettd@ninds.nih.gov>

[]{#__RefHeading___Toc219687163 .anchor}Clinical Trials

The NINDS is committed to identifying effective treatments for
neurological disorders by supporting well-executed clinical trials.
NINDS may decline funding of a clinical trial proposal for programmatic
or administrative reasons. SBIR applicants are strongly encouraged to
contact Joanne Odenkirchen (contact information provided below) within
NINDS Clinical Trials Group for advice about potential clinical trial
proposals *prior* to submission in order to determine the relevance of
the proposed research to NINDS and its potential for translating
discoveries to clinical interventions for neurological disorders.

Joanne Odenkirchen, M.P.H.

National Institute of Neurological Disorders and Stroke

301-496-3104

Email: <jo21x@nih.gov>

[]{#__RefHeading___Toc219687164 .anchor}Specific Research Topics of
Interest to NINDS and affiliated programmatic areas

Examples of research topics within the mission of the NINDS that may be
of interest to small businesses are shown below. This list is not all
inclusive and some research areas fall into multiple categories (e.g.
countermeasures against chemical threats). 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/).

I. Clinical and Rehabilitation Tools

A. *[Intraoperative Technologies]{.underline}*

1\. 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.

2\. Develop technologies that allow neurosurgeons to repair the brain
with minimal collateral damage (e.g., robotics, remote targeting,
nanoscale deep brain stimulation).

3\. Develop devices and methods for the removal of blood clots in the
ischemic CNS.

B. *[Rehabilitation Devices and Programs]{.underline}*

1\. Develop comprehensive rehabilitation strategies that include active
exercise, motor, sensory and cognitive retraining; studies into central
control in dystonia and other movement disorders, including EMG,
kinematics and cortical assessment.

2\. Develop strategies to improve vocational outcomes and reduce social
isolation of patients with neurological disorders.

3\. Develop, test, and evaluate devices to aid in the treatment and
recovery following stroke or other disorders that disrupt normal
sensory-motor functions.

4\. Develop computer-aided behavioral therapies that stimulate circuit
rewiring and retraining after injury or disease.

5\. Develop effective rehabilitation approaches for enhancing cognitive
and sensorimotor performance through enriched virtual reality
environment.

6\. Develop innovative approaches to facilitate sensorimotor functional
recovery through robotic assisted motor learning.

7\. Develop tools for therapeutic electrical stimulation for
rehabilitation following stroke or other disorders that disrupt normal
sensory-motor functions.

8\. Develop effective and practical approaches or strategies for
transcranial magnetic or electrical stimulation of sensorimotor
structures to facilitate post-injury reorganization.

9\. Develop assistive devices, orthotics and robotic therapy, for
individuals with neurological disorders (i.e. muscular dystrophy, spinal
muscular atrophy, dystonia, spinal cord injury, amyotrophic lateral
sclerosis, and others).

10\. Develop communication aids for individuals with "locked-in
syndrome."

C. *[Monitoring Systems]{.underline}*

1\. Develop standardized instruments and other tools:

a\. To facilitate computerized neuropsychological testing of
neurologically impaired subjects

b\. To assess sensorimotor performance in human and experimental animals

c\. To use automated systems for the assessment of behavioral parameters

d\. To measure quality of life, cognitive function, and central nervous
system function for individuals with muscular dystrophy and other
neurodegenerative disorders

e\. For early or presymptomatic diagnosis, including cognitive measures,
for neurodegenerative disorders

2\. Develop improved methods and tools:

a\. To monitor compliance/medication dispensing for epilepsy

b\. To study the features of pain in dystonia, including how treating
pain may affect the underlying disability

c\. To categorize sleep stages on line -- especially in human infants
and patients with EEG-distorting brain dysfunction

d\. To quantify optimal alertness

e\. For real-time analysis of sensorimotor neurophysiological events *in
vivo*

f\. To diagnose different pain mechanisms and objective measures of
analgesic drug action

3\. Further develop portable devices which provide cost-effective
screening to monitor potential and already diagnosed sleep disorders.

4\. Develop technologies for primary care physicians, emergency workers,
or patients, that can be routinely used to monitor neurological heath or
detect and diagnose neurological disorders at early stages (e.g. PDAs
with personal neurological sensors).

5\. Develop technologies to provide patients with timely access to
neurological expertise, even if a neurologist is not immediately or
locally available (e.g. telemedicine, artificial intelligence-guided
diagnostic alerts).

6\. Develop technologies for collecting and analyzing multiple
parameters of brain trauma in the ICU.

7\. Develop monitors for modalities such as intracranial pressure, brain
temperature, and cerebral blood flow and oxygenation.

8\. Develop a portable hand-held technology for the diagnostic
assessment of brain injury.

9\. Develop devices for automated detection and quantification of
seizures in humans.

II\. Therapeutics and Diagnostics

A. *[Biomarkers and Diagnostic Assays]{.underline}*

1\. Develop technologies to aid the diagnosis of neurological disorders,
including development of more minimally invasive diagnostic techniques.

2\. Develop improved diagnostic and prognostic biomarkers, including the
use of imaging, EEG, gene expression arrays, and proteomic and
metabolomic approaches for neurological disorders.

3\. Develop and evaluate novel biomarkers and diagnostic assays for
neurological disorders, including:

a\. Epileptogenesis

b\. Vascular and inflammatory diseases of the brain

c\. CNS and PNS tumors

d\. Infectious and immune CNS disorders.

e\. Diagnosis and therapeutic monitoring of neurodegenerative disease

f\. Acute stroke (ischemic vs. hemorrhagic)

g\. Traumatic brain injury

h\. Spinal cord injury

4\. Develop a rapid and sensitive assay for the detection of normal and
variant prions as well as the detection and isolation of various prion
strains.

B. *[Cell Therapy]{.underline}*

1\. Develop methods to deliver cells to injured brain and spinal cord
sites to enhance regeneration or restoration of function.

2\. Develop ex vivo approaches to enhance therapeutic gene delivery into
the nervous system.

C. *[Gene Therapy]{.underline}*

1\. Develop techniques for brain specific antisense, gene and protein
transfer into cerebrovascular, neurons, or glial cells in CNS and PNS
tumors.

2\. Develop brain specific gene and protein transfer methods that target
cerebral vessels, neurons, and/or glia in the ischemic or hemorrhagic
brain.

3\. Develop methods to deliver genes to injured nervous system to
enhance regeneration or restore function.

4\. Develop regulatable vectors for treatment of chronic
neurodegenerative disorders.

5\. Develop new approaches for gene replacement or correction in
inherited neuromuscular diseases.

6\. Develop siRNA approaches towards treatment of neuorlogical
disorders.

D. *[Drug Development]{.underline}*

1\. Discovery and development of drugs or other agents to prevent,
palliate, arrest, or reverse neurological disorders, including:

a\. Autoimmune neurological disorders (i.e. multiple sclerosis)

b\. Spinal muscular atrophy and the muscular dystrophies

c\. Neurodegenerative diseases

d\. Spinal cord injury and traumatic brain injury

e\. Stroke

f\. CNS and PNS cancer

g\. Infections of the nervous system

h\. Sleep disorders

2\. Develop drugs or other agents to reduce scarring after spinal cord
injury and traumatic brain injury.

3\. Develop drugs to control the inflammation involved with stroke.

4\. Develop and test combination therapies for stroke.

5\. Evaluate the efficacy of existing anti-inflammatory drugs for
treatment of muscular dystrophy and translate it to the clinic.

6\. Identify genetic modifiers of SMN expression and function and
validate these as targets for therapy development in spinal muscular
atrophy.

E. *[Drug Delivery]{.underline}*

1\. Develop instruments, devices, and methodologies to deliver
therapeutics (gene vector, drugs, enzymes, proteins, or other molecules)
across the blood-brain or blood-CSF barrier.

2\. Develop drugs with high blood-brain barrier permeability intended
for treatment of neurological disorders, including:

a\. CNS infections including HIV-related opportunistic infections

b\. Targeting brain and spinal cord tumors

3\. Develop methods or vectors for the delivery of biologics (e.g.,
cytokines, DNA), drugs, and other agents to the nervous system or to
specific cells or regions.

4\. Develop new formulations and delivery systems for antiepileptic
drugs.

5\. Improved methods to deliver neurotrophic factors and other small
proteins or peptides normally found in the brain.

6\. Develop reagent delivery systems for treatment of chronic
neurodegenerative disorders.

7\. Develop methods to deliver neurotrophic factors to injured brain
sites to enhance regeneration or restoration of function.

F. *[Therapeutic Devices]{.underline}*

1\. Develop, test, and evaluate devices to aid in the treatment of
neurological disorders, including:

a\. Neurodegenerative disorders

b\. Stroke and stroke inflammation

c\. CNS and PNS tumors

d\. CNS infections

e\. Acute or chronic pain

f\. Sleep disorders

2\. Develop biomaterials to serve as paths for supporting or guiding
axonal growth across a site of injury in the nervous system.

3\. Develop biomaterials to promote dendritic growth and stability, and
synapse formation in localized areas.

4\. Develop endovascular devices to restore blood flow to the brain in
people who have ischemic stroke or compromised vascular flow that puts
the brain at risk.

5\. Develop nanocapsules or wafers for controlled delivery of
therapeutic products in the brain for patients with lysosomal storage
and other neurological disorders.

6\. Develop comprehensive studies into surgical interventions in
dystonia, in which genetic status, phenotype, lead location, programming
parameters, definition of therapeutic target volume in applying DBS is
delineated; and new targets for DBS such as STN, thalamus, brainstem and
cerebellum are considered.

III\. Technology and Tools

A. *[General Imaging]{.underline}*

*[Radioligands and Markers]{.underline}*

1\. Develop tools to enhance visualization of specific brain markers.

2\. Develop radioligands for functional imaging of targeted molecules
implicated in normal brain function and brain disorders.

3\. Design highly specific radiolabeled markers for different types of
brain tumors that can be used under histopathological or brain imaging
conditions.

*[Software]{.underline}*

1\. Create software for improving interoperability of neuroimaging data.

2\. Develop software that integrates imaging and physiological measures
of brain activation.

*[Technology, Techniques and Devices]{.underline}*

1\. Develop functional imaging techniques.

2\. Develop combined imaging strategies, i.e., fMRI and PET.

3\. Develop non-invasive optical imaging approaches.

4\. Develop 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.

5\. Develop MRI technology for use in the ICU.

6\. Develop ultrasound imaging methods for the central nervous system.

7\. Develop early or presymptomatic imaging modalities for
neurodegenerative disorders.

8\. Develop imaging techniques to track the course of injury and repair
following spinal cord injury and traumatic brain injury.

9\. Expand brain imaging capabilities to include refinement of
functional, structural and metabolic imaging techniques:

a\. In the ischemic brain

b\. For brain and spinal cord tumors

c\. For CNS infections

10\. Develop and validate the role of muscle imaging in diagnostic
evaluation or as an endpoint measure for clinical trials in muscular
dystrophy.

B. *[Pediatric Brain Imaging]{.underline}*

*[Software]{.underline}*

1\. Develop computer software to permit reconstruction of magnetic
resonance imaging (MRI) from unrestrained patients or animals that may
change position within the MRI magnetic field.

2\. Develop 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.

*[Technology, Techniques and Devices]{.underline}*

1\. Develop technology to assess fetal neurological integrity such as
fetal MEG.

2\. Develop 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.

3\. Develop non-invasive techniques for structural imaging, such as near
infrared imaging.

4\. Develop practical imaging modalities in extremely ill very low birth
weight infants.

5\. Develop 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.

6\. Develop 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.

C. *[Neural Prosthesis]{.underline}*

1\. Develop neuroprosthetic devices that integrate with the brain to
restore sensory, motor, or cognitive functions lost through disease or
injury.

2\. Develop new devices both for the control of seizures and for the
prevention of epilepsy.

3\. Develop innovative approaches for evoking sensory response of
specific modalities by discrete stimulation of brain structures or
pathways.

4\. Design, develop, and evaluate neural recording and stimulating
microelectrodes for neural prostheses and deep brain stimulation.

5\. Develop thin, insulating coatings to make implanted electronic
packages impervious to the corrosive action of body fluids and tissues.

6\. Develop transducers of position, touch, and force for use in
functional electrical stimulation systems.

7\. Develop addressable arrays of sub-micron or nano-scale dimension
electrodes for use in the CNS.

8\. Develop non-invasive methods to focally stimulate small populations
of neurons within the body.

9\. Develop a complete system utilizing existing microelectrodes, lead
wires and telemetry to transfer neural signals outside the body.

10\. Develop new high charge density electrode materials.

11\. Develop a method to repeatedly inhibit neuronal electrical activity
in a safe and effective manner.

12\. Develop a non-invasive method of selectively stimulating and/or
inhibiting small groups of nerve fibers within a nerve trunk.

13\. Develop materials to minimize scarring following surgery in the
central nervous system.

14\. Develop techniques for precise functional placement of
microelectrodes within the central nervous system.

15\. Develop neural controllers to restore micturition and defecation
for individuals with spinal cord lesions.

16\. Development and implement automated signal processing algorithms in
hardware or software capable of neural signal analysis for neural
prosthetics applications.

17\. Develop novel nerve cuff electrode or nerve interface technologies
capable of selective stimulation and/or recording from intact afferent
and efferent nerve bundles.

D. *[Research Resources]{.underline}*

Improve the development, robustness, and user-friendliness of new
technologies from basic and clinical perspectives to study the brain and
behavior. These technologies include: hardware (e.g., instruments and
devices), software (e.g., computational models, informatics tools, and
data analytic methods, etc.) and wetware (e.g., cell-free assays,
bioactive agents, and imaging probes). 

Lab to Marketplace: Tools for Brain and Behavioral Research
<http://grants.nih.gov/grants/guide/pa-files/PA-08-071.html>.

*[Drug Development Tools]{.underline}*

1\. Develop drug screening assays (including small molecule,
biochemical, cellular or model organism assays) for high-throughput
screening approaches to aid in the development of therapies for
neurological disorders.

2\. Develop cell-based assays that target aspects of pathogenesis and
pathophysiology in spinal muscular atrophy and the muscular dystrophies,
to enable high throughput drug screening.

3\. Develop optimized models of specific muscular dystrophies
appropriate for therapeutic development screens.

4\. Develop techniques such as microarray, gene expression analysis or
immunological techniques that allow studies on the mechanisms and
effects of therapies.

5\. Develop new models of seizures and epilepsy useful for screening
therapies.

6\. Development and characterizate stem cell lines carrying mutations
related to familial forms of neurodegenerative diseases for medium
throughput screening approaches.

7\. Develop high- or middle-throughput screening systems, and validate
their usefulness to efficiently assess libraries of potential
therapeutics for brain, spinal cord or peripheral nervous system injury.

*[In vivo and In vitro Models]{.underline}*

NIH has an official policy on sharing of model organisms for biomedical
research. This policy applies to extramural investigators who anticipate
generating new, genetically modified model organisms and related
resources pursuant to any type of NIH award---grants, cooperative
agreements, and contracts, including SBIR and STTR awards. In some
cases, an applicant can state why sharing is restricted or not possible.
For more information:
<http://grants.nih.gov/grants/policy/model_organism/index.htm>.

1\. Develop models of the blood-brain-barrier.

2\. Develop models of neurological sleep disorders.

3\. Develop new models of seizures and epilepsy useful for screening
therapies.

4\. Develop embryonic stem cell models of nervous system development and
function.

5\. Develop novel pain model systems, particularly more accurate
pre-clinical experimental models.

6\. Create and validate animal models for developing drug screening
assays and for testing therapeutic strategies in neurological disorders.

7\. Develop optimized models for mechanistic studies of specific
muscular dystrophies, including models appropriate for therapeutic
development screens.

8\. Evaluate existing *in vitro* and *in vivo* models of spinal muscular
atrophy and develop models that fill gaps in our ability to validate
therapeutic targets and develop novel, targeted therapies.

9\. Develop large animal models including non-human primate models of
neurodegenerative diseases and other sensorimotor disorders.

10\. Improve methodologies for creating transgenic animal models for
diseases in the nervous system.

11\. Develop and validate large and small animal models, including
transgenic, knockout, and inducible knockout animals that reflect the
complexity and diversity of the human brain and its responses during
ischemia.

12\. Develop and validate transgenic, knockout and inducible knockout
animal models for:

a\. Stroke and CNS trauma research

b\. Infectious and immune CNS disorders

c\. Transmissible Spongiform Encephalopathy research

*[Research Instrumentation]{.underline}*

1\. Develop medium to high throughput techniques for studying channels,
transporters, receptors and synapses.

2\. Develop technology for single-cell analysis of neurons and glia to
detect dynamic changes in the transcriptome, proteome, and metabolome.

3\. Develop technology for micro dissection of brain tissue for single
cell analysis of gene expression.

4\. Develop technology to detect and quantify changes in metabolites
(carbohydrates, lipids, peptides) changes in the nervous system.

5\. Develop mass spectrometry for the analysis of protein in the CNS and
in brain tumors.

6\. Develop technologies to monitor the activity of many individual
neurons simultaneously, over long periods of time, in behaving animals,
including people.

7\. Develop technologies to image at the molecular level in vivo, in
real time.

8\. Develop technologies to identify and classify different cell types
in the nervous system.

9\. Develop techniques and devices for imaging of small animals such as
transgenic and knockout animal models of complex behaviors.

10\. Develop methodologies and tools for real-time analysis of
sensorimotor neurophysiological events in vivo.

11\. Develop innovative techniques for collecting large and multiple
scales of neural signals from cortical and subcortical sensory and motor
structures.

12\. Develop devices for automated detection and quantification of
seizures in animal models.

*[Research Systems/ Wetware]{.underline}*

*[Genomics and Proteomics]{.underline}*

1\. Identify optimal DNA vector systems to standardize and expedite the
sequencing of cDNA libraries derived from micro dissected brain tissues.

2\. Develop 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.

3\. Develop *in vitro* methods to either fractionate membrane proteins
or express recombinant membrane proteins at sufficient levels for
proteomics analyses.

4\. Develop proteomics technologies to quantitatively detect levels of
expression, post-translational modifications, and subcellular
distribution of proteins in the nervous system.

5\. Develop improved techniques for molecular analysis of DNA, RNA, and
protein in CNS and PNS tumors.

6\. Develop techniques for brain specific antisense, gene and protein
transfer into cerebrovascular, neuronal, or glial cells in CNS and PNS
tumors.

7\. Develop methods and devices for high throughput genomic and
proteomic analyses of CNS and PNS tumors.

8\. Develop applications of proteomic and/or metabalomic methods to
detect sleep deprivation.

9\. Develop brain specific gene and protein transfer methods that target
cerebral vessels, neurons, and/or glia in the ischemic or hemorrhagic
brain.

*[Stem Cells]{.underline}*

1\. Develop efficient and reproducible methods for harvesting and
storing stem cells for research use.

2\. 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.

3\. Develop methods for phenotyping stem and progenitor cells in the
nervous system.

4\. Develop methods for identification of specific neural cell lineages.

5\. Develop methods and reagents that allow tracking of grafted cells in
the living host animal using non-invasive imaging methodologies.

*[Other Tools]{.underline}*

1\. Develop tools, assays, and strategies to facilitate ion channel,
receptor and transporter-related research.

2\. Develop tools to elucidate potential analgesic targets, and models
for testing and validating these for efficacy in patients.

*[Software]{.underline}*

1\. Develop neuroinformatics techniques, including research, development
and application of informatics tools to acquire, store, organize,
archive, analyze, or visualize neuroscience and neurological data,
particularly large quantities of complex and dynamic data, including
clinical data.

2\. Computational neuroscience, including the research, development and
application of computational data-analytical and theoretical methods,
mathematical modeling and computational simulation techniques to studies
of the nervous system.

3\. Develop technologies to facilitate high-throughput analysis of
behavior.

4\. Develop 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.

5\. Develop bioinformatic databases for stroke to include sharing of
clinical, genomic, and/or proteomic data.

6\. Develop a complete anatomical connectivity map of the human brain.

Small Business Research Funding Opportunities:

-   Bioengineering Nanotechnology Initiative

<http://grants.nih.gov/grants/guide/pa-files/PA-06-008.html> (STTR)

<http://grants.nih.gov/grants/guide/pa-files/PA-06-009.html> (SBIR)

-   Manufacturing Processes of Medical, Dental, and Biological
    Technologies

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

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

-   Development of PET and SPECT Ligands for Brain Imaging

<http://grants.nih.gov/grants/guide/pa-files/PA-06-018.html> (STTR)

-   Probes for Microimaging the Nervous System

<http://grants.nih.gov/grants/guide/pa-files/PA-06-022.html> (STTR)

<http://grants.nih.gov/grants/guide/pa-files/PA-06-021.html> (SBIR)

-   Innovations in Biomedical Computational Science and Technology
    Initiative

<http://grants.nih.gov/grants/guide/pa-files/PAR-07-161.html> (STTR)

<http://grants.nih.gov/grants/guide/pa-files/PAR-07-160.html> (SBIR)

-   Advanced Tools and Technologies for Deep Brain Stimulation in
    Movement Disorders

<http://grants.nih.gov/grants/guide/pa-files/PA-07-395.html> (STTR)

<http://grants.nih.gov/grants/guide/pa-files/PA-07-396.html> (SBIR)

-   Neurotechnology Research, Development, and Enhancement

<http://grants.nih.gov/grants/guide/pa-files/PA-07-390.html> (STTR)

<http://grants.nih.gov/grants/guide/pa-files/pa-07-389.html> (SBIR)

-   New Technology for Proteomics and Glycomics

<http://grants.nih.gov/grants/guide/pa-files/PA-07-452.html> (STTR)

<http://grants.nih.gov/grants/guide/pa-files/PA-07-451.html> (SBIR)

-   High Throughput Tools for Brain and Behavior

<http://grants.nih.gov/grants/guide/pa-files/PA-08-002.html> (STTR)

<http://grants.nih.gov/grants/guide/pa-files/PA-08-001.html> (SBIR)

-   Lab to Marketplace:  Tools for Brain and Behavioral Research

<http://grants.nih.gov/grants/guide/pa-files/PA-08-071.html> (SBIR)

-   Probes and Instrumentation for Monitoring and Manipulating Nervous
    System Plasticity

<http://grants.nih.gov/grants/guide/pa-files/PA-08-146.html> (SBIR)

-   Research Supplements to Promote Diversity in Health-Related Research

<http://grants.nih.gov/grants/guide/pa-files/PA-08-190.html> (STTR,SBIR)

<http://grants.nih.gov/grants/guide/pa-files/PA-08-191.html> (STTR,SBIR)

-   Technological Innovations for Interdisciplinary Research
    Incorporating the Behavioral and Social Sciences

<http://grants.nih.gov/grants/guide/pa-files/PAR-08-201.html> (STTR)

<http://grants.nih.gov/grants/guide/pa-files/PAR-08-202.html> (SBIR)

For additional information on research topics, contact:

*[Neurodevelopment and Neurogenetics]{.underline}* -- Neurogenetic and
neurodevelopment research, genetic causes of neurological disease,
research on diseases with a large genetic component, and gene-based
therapeutics for neurological disorders

Dr. John Porter

Program Director

National Institute of Neurological Disorders and Stroke

301-496-5745: Fax: 301-402-1501

Email: <jp477n@nih.gov>

*[Repair and Plasticity]{.underline}* -- Neuroengineering, neural
prosthesis, stem cell research, traumatic injury to the nervous system
(i.e. spinal cord injury, traumatic brain injury), nervous system repair

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}* -- Rehabilitation and
research focused on higher brain functions that underlie complex
behavioral phenomena (i.e. learning, memory, attention, language,
cognition, emotion, movement, the wakefulness-sleep cycle, response to
pain, and feeding)

Dr. Daofen Chen

Program Director

National Institute of Neurological Disorders and Stroke

301-496-9964, Fax: 301-480-2424

Email: [dc342b@nih.gov](mailto:cd342b@nih.gov)

*[Channels, Synapses & Circuits]{.underline}* -- Basic, translational
and clinical research in channels, synapses, and neural circuits that
underlie normal brain functions and dysfunctions related to neurological
disorders, such as epilepsy

Dr. Randall R. Stewart

Program Director

National Institute of Neurological Disorders and Stroke

301-496-1917, Fax: 301-402-1501

Email: <rs416y@nih.gov>

*[Neurodegeneration]{.underline}* -- Research on treatment and
prevention of adult onset neurodegenerative diseases of all types,
including Parkinson's, Alzheimer's, Hunington's, and ALS

Dr. Margaret Sutherland

Program Director

National Institute of Neurological Disorders and Stroke

301-496-5680, Fax: 301-480-1080

Email: <sutherlandm@ninds.nih.gov>

*[Neural Environment]{.underline}* -- Research on glial and
cerebrovascular cell function in normal and pathological states (i.e.
cancer and stroke), as well as immune cell function (i.e. MS) and
infectious agents (i.e. AIDS) in the diseased nervous system

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>

*[Office of Translational Research]{.underline}*

Dr. Jill Heemskerk

Acting Associate Director for Technology Development

National Institute of Neurological Disorders and Stroke

301-496-1779; Fax: 301-402-1501

Email: <heemskej@ninds.nih.gov>

*[Clinical Trials]{.underline}*

Joanne Odenkirchen, M.P.H.

Clinical Research, Project Manager

National Institute of Neurological Disorders and Stroke

301-496-3104, Fax: 301-480-1080

Email: <jo21x@nih.gov>

For administrative and business management questions, contact:

Ms. Kimberly Campbell

Grants Management Specialist

National Institute of Neurological Disorders and Stroke

6001 Executive Boulevard, Room 3254

Bethesda, MD 20892

301-496-7809, Fax: 301-402-0219

Email: <campbelk@mail.nih.gov>

[]{#__RefHeading___Toc219687165 .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___Toc219687166 .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___Toc219687167 .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___Toc219687168 .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___Toc219687169 .anchor}National Center for Research
Resources (NCRR)

NCRR provides laboratory scientists and clinical researchers with the
environments and tools they need to understand, detect, treat, and
prevent a wide range of diseases. This support enables discoveries that
begin at a molecular and cellular level, move to animal-based studies,
and then are translated to patient-oriented clinical research, resulting
in cures and treatments for both common and rare diseases. Through the
small business program, NCRR supports primary research to create and
develop critical resources, models, and technologies.

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___Toc219687170 .anchor}Phase II Competing Renewal
Awards

The NCRR will accept Phase II SBIR Competing Renewal grant applications
to continue research and development of complex instrumentation and
tools for basic, translational or clinical research where extraordinary
time and effort is needed for their research and development. The Phase
II Competing Renewal award is intended to allow small businesses the
opportunity to reach to a stage where interest in and investment by
third parties would be more likely. Such products are expected to have a
broad applicability, consistent with the mission of NCRR. Budgets not
exceeding \$1 M per year, and time periods up to 3 years may be
requested for this Phase II Competing Renewal opportunity, although it
is expected that in most cases the requested budget would not exceed
with the final year budget of the applicant's previous phase II award.

Please contact your Program Officer and Dr. Amy Swain before beginning
the process of preparing an application. 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 organizations

-   Funding Opportunity Announcement Number (e.g., PA-09-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 few of NCRR
SBIR Phase II awards will be eligible for a Competing Renewal grant.

Research Topics of Interest to NCRR:

[]{#__RefHeading___Toc219687171 .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,
imaging, optical or laser spectroscopies, X-ray
absorption/diffraction/scattering, detectors, electron or confocal
microscopies, electrophoresis and other separation techniques,
bioreactors, centrifugation, and flow cytometry.

B. Development of information technology, computer and other
mathematical sciences in support of biomedical or behavioral research.
This may include:

1\. Computer simulations and modeling.

2\. Creating resources for clinical and biomedical research such as

a\. long-term sustainable environments for scientific databases;

b\. tools to re-engineer databases for federation;

c\. biomedical science commons.

3\. Developing computational infrastructures that enable creation of
coherent biomedical knowledge. These may include methods and tools for

a\. re-use and re-purposing of datasets and models;

b\. assessment of informational value of data for re-purposing;

c\. assessment of data, information, and knowledge providence, linking
it to the workflows and protocols of data collection, cleansing and
processing;

d\. integration of heterogeneous data sources. Applicants are encouraged
to utilize interdisciplinary methods (e.g. graph theory, principal
component analysis, differential geometry, etc) to enable meaningful
exploration of high-dimensional data spaces;

e\. data discovery, validation, reverse engineering of underlying data
models; extraction of study designs and data processing protocols from
the text of the scientific publications, and evaluating how they fit
together;

f\. extracting conceptual models from scientific and health-related
publications and representing them for defined audiences;

g\. connecting personal health record with the abundance of existing
health information and knowledge.

4\. Use of Web 2.0 technologies for

a\. creating collaborative environments for networking, tool development
and communication of biomedical information;

b\. creating personalized user interfaces;

c\. enabling translation of basic science;

d\. delivering complex scientific information to different audiences;

e\. developing interactive two-way learning environments where the user
gets education on various health issues while the system improves
personalized information delivery based on the conceptual framework of
the user.

5\. Visualization that assists in exploring multidimensional scientific
and health-related data and information, and in understanding and
communicating complex concepts. Some examples of visualization include

a\. Maps of existing databases, data elements, and standards;

b\. Personal health atlases;

c\. Evolution of scientific domains, collaborations, and concepts;

d\. Landscape of science where a location and interconnectivity of an
entity (scientist, organization, paper, or concept) can be identified;

e\. Scientific forecasts;

f\. Pathways for translating Discovery into Innovation.

C. Development of novel technologies for proteomics and glycomics
discovery and clinical applications, 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>

*[Computer Science and Informatics]{.underline}*

Dr. Olga Brazhnik

Division of Biomedical Technology, NCRR

301-435-0755

Email: <Brazhnik@mail.nih.gov>

*[NMR, Optical Microscopy, Laser Applications]{.underline}*

Dr. Fred Friedman

Division of Biomedical Technology, NCRR

301-435-0755

Email: [FFriedma@mail.nih.gov](mailto:Ffriedma@mail.nih.gov)

*[Imaging Technologies]{.underline}*

Dr. Abraham Levy

Division of Biomedical Technology, NCRR

301-435-0755

Email: <LevyAbra@mail.nih.gov>

*[Proteomics, Mass Spectrometry]{.underline}*

Dr. Douglas Sheeley

Division of Biomedical Technology, NCRR

301-435-0755

Email: <SheeleyD@mail.nih.gov>

[]{#__RefHeading___Toc219687172 .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).

Q. Development of computational science-based technologies to create
fast, effective community access to preclinical animal models-based raw
data, processed data, and processing tools.

Dr. Michael Chang

Comparative Medicine, NCRR

301-435-0744, Fax: 301-480-3819

Email: <ChangMic@mail.nih.gov>

[]{#__RefHeading___Toc219687173 .anchor}Clinical Technology Applications

A. Development of patient-centered research technologies for
communication, management, diagnosis, monitoring, evaluation, tracking,
safety, accessibility, training, and treatment. These technologies could
include therapies, diagnostics, education, protocol and evidence based
care communications, disease prevention techniques, systems and
organizational management, comparative effectiveness, sensors, clinical
and surgical tools, accessibility tools, and imaging. Monitoring,
tracking and communication technologies may be mobile,
computer-mediated, or video-based and may employ remote consultation
communications, wireless devices, and telecommunications. Innovative,
economical, secure, HIPAA compliant, and interoperable technologies are
encouraged.

B. Diversification and development of methods and devices used for
clinical and translational research, such as clinical tools, monitoring
processes, evaluation tools, communications, health literacy assessment
and education implementation tools for medical/health care trainees or
the community, patient safety risk assessment and mitigation tools,
health care quality assessment tools, systems and organizational
management, comparative effectiveness, microanalytical sensors, surgical
devices, imaging devices, and accessible technology. Ultimate end users
of the developed technology would include any of the following:
researchers, medical/health care and allied health providers, medical
institutions, hospitals, urgent care or health care centers,
laboratories, radiology centers, health care administrators, or
patients.

C. Development of medical and health care computer and communication
technologies in clinical and translational research: (1) health
information technologies that support health care information systems;
(2) software, hardware, or web-based databases, IRB, clinical trial
study, or protocol tracking systems, health care data quality, health
information security systems, and participant enrollment information
tracking; (3) wireless systems and infrastructure; (4) interoperable,
economical, accessible, and user-friendly computing.

D. Development of research informatics and information technologies: (1)
collecting, collating, and archiving of databases; (2) testing
interoperability and compatibility across technologies and their
accessibility and usability; (3) protected storage and transmission of
confidential medical data; and (4) for facilitating the review or
implementation of clinical and translational research protocols; (5) for
processing data from multiple and simultaneous clinical and
translational research protocols across multiple clinical sites; and (6)
for instrumentation to support clinical imaging data.

E. Development of technologies that enable use of electronic medical
records (EHR) and personal health records (PHR) for clinical and
translational research purposes. Elements could include(1) the
collection, collation, and archiving of databases; (2) interoperability
and compatibility among technologies and their accessibility and
usability; (3) utilizing vetted and approved standards for the
development of databases; (4) systems which facilitate the review or
implementation of clinical and translational research protocols; (5)
development of software to process data from multiple clinical and
translational research protocols across multiple clinical sites; (6)
security systems development to protect storage and transmission of
confidential medical data; and (7) development of standardizing
agreements for patient privacy and protection.

F. Miniaturization of existing biomedical technologies for adaptation to
pediatric use.

G. Development of innovative vehicles for drug delivery in multiple
patient groups including those with a potential for altered pharmacology
or adherence, such as children, the elderly, or persons with
disabilities.

H. Development of vectors for gene therapy, with improved: (1) targeting
of specific cells and/or tissues; (2) transduction and expression; (3)
delivery to patients; and/or (4) production and purification. This
extends to the development of techniques, instruments, reagents and
vector systems for use in clinical gene therapy protocols.

I. Development of high throughput technologies, methods, and techniques
for studies of human diseases.

J. Development of techniques, instruments and reagents to optimize the
recovery and quality of cells obtained from human tissues and organs for
subsequent use in basic, clinical, or translational research.

*[Patient Centered and Clinical Methods and Technologies; Clinical,
Medical, & Health Care Informatics; Communication and Computer
Technologies; and General Clinical Research Technologies, Tools, and
Devices]{.underline}*

Rosemarie Filart, MD MPH, MBA

Division of Clinical Research, NCRR

301-435-0178, Fax: 301-480-3661

Email: <filartr@mail.nih.gov>

*[Electronic Medical Records; Personal Health Records; Drug Delivery
Technologies, Tools, and Devices; and Research Informatics]{.underline}*

Jody Sachs, DPM

Division of Clinical Research, NCRR

301-435-0802, Fax: 301-480-3661

Email: <SachsJG@mail.nih.gov>

*[Human Stem Cell Technologies, Methods, and Tools]{.underline}*

Tony L. Beck, PhD Division of Clinical Research, NCRR

301-435-0805, Fax: 301-480-3661

Email: <BeckL@mail.nih.gov>

[]{#__RefHeading___Toc219687174 .anchor}Development of
Discovery-Oriented Software and Tools for Science and Health Education

Funding opportunities are available for the development of
discovery-oriented educational software and the application of
educational technology and tools for health science topics that target
K-12 students, families, students from community, tribal and
undergraduate colleges and the general public. Topics can range from
basic biological science to specific human diseases. Examples include
but are not limited to regenerative medicine and bioengineering, how
different parts of the body work across the lifespan, healthy living and
lifestyle, mental health, and prevention of heart disease, diabetes, and
other chronic diseases. Development of software, technology, or tools
may be directed toward new products or adaptation of existing products
designed to be more efficient, cost-effective, and user-friendly in
promoting interactive learning, dissemination and promotion of health
science. This effort is intended to yield efficient and user-friendly,
culturally appropriate and effective educational units that can be
extended to enhance the health science literacy of the general public. A
broad dissemination is strongly encouraged.

Examples of responsive proposals may include but are not limited to:

-   Web-based, stand-alone computational tools, instructional software
    or other interactive media for dissemination of science education

-   Curriculum materials, Interactive teaching aids and models for
    classroom instruction, and teacher education workshops

-   Development of health promotion and disease prevention/intervention
    materials such as informational videos and/or print materials and
    programs which are culturally appropriate for populations and
    special communities.

Projects that target the following constituencies are strongly
encouraged:

-   K-12 students

-   Students of community colleges, tribal colleges, undergraduate
    colleges and minority-serving institutions

-   Patients and families with health conditions that disproportionately
    affect minority and other medically underserved populations,
    including members of disadvantaged urban and rural communities.

Dr. Krishan Arora

Research Infrastructure, NCRR

301-435-0788, Fax: 301-480-3770

Email: <ka31h@nih.gov>

[]{#__RefHeading___Toc219687175 .anchor}Other Research Topic(s) Within
the Mission of the Center

NCRR's Division of Research Infrastructure supports programs such as
Research Centers in Minority Institutions (RCMI) and Institutional
Development Award (IDeA) that support and foster health-related research
to build capacity at minority serving institutions and in underserved
states, respectively. These programs support a wide variety of
biomedical research, including clinical and translational research to
reduce health disparities experienced by disadvantaged groups and
medically underserved populations. Applications involving partnerships
with minority-serving institutions and IDeA-eligible institutions are
strongly encouraged. Topics of special interest include:

-   Development and/or refinement of culturally appropriate survey
    instruments, tools and databases to promote community based research
    engaging minority, rural and other medically underserved
    populations;

-   Development of methodologies, diagnostics, technologies, equipment,
    assay systems and portable devices that can be used in community
    settings, such as health centers, neighborhood clinics, doctors
    offices, public schools, libraries, and rural and remote locations
    to facilitate biomedical and behavioral research;

-   Development of culturally appropriate health promotion and disease
    prevention/intervention educational materials such as software,
    videos and printed material to facilitate translation and
    dissemination of evidence-based health information;

-   Innovative applications of health information technology, including
    telemedicine/telehealth tools and technologies, to facilitate
    electronic health information exchange, enable clinical research at
    the point of care, and improve access to quality health care for
    hard to reach populations.

Dr. Krishan Arora

Research Infrastructure, NCRR

301-435-0788, Fax: 301-480-3770

Email: <arorak@mail.nih.gov>

Dr. Michael Sayre

Research Infrastructure, NCRR

301-435-0788, Fax: 301-480-3770

Email: <sayrem@mail.nih.gov>

Dr. Rafael Gorospe

Research Infrastructure, NCRR

301-435-0788, Fax: 301-480-3770

Email: <gorospejr@mail.nih.gov>

For additional information on NCRR research topics, contact:

Dr. Amy Swain

National Center for Research Resources

301-435-0755, Fax: 301-480-3658

Email: <swaina@mail.nih.gov>

For administrative and business management questions, contact:

Ms. Leslie Le

National Center for Research Resources

301-435-0856, Fax: 301-480-3777

Email: <LeLeslie@mail.nih.gov>

[]{#__RefHeading___Toc219687176 .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___Toc219687177 .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
development and validation of:

-   technology for standardization and characterization of products used
    in CAM research;

-   methods for standardization and characterization of active
    components of mind-body medicine interventions;

-   innovative biomarkers for measurement of stress in studies also
    testing efficacy of CAM therapies;

-   standardized, reliable and economical tools that correlate with
    brain imaging to assess brain function;

-   technical imaging tools or instruments for studying manual
    therapies;

-   CAM-based tools for pain management;

-   innovative tools, technology and instruments for the accurate
    assessment of adherence to the use of CAM practices, interventions,
    and products;

-   tools to improve patient-reported outcome measures of CAM clinical
    investigations;

-   tools to improve biological and physiological outcome measures of
    CAM clinical investigations.

[]{#__RefHeading___Toc219687178 .anchor}Topics That Are of Less Interest
to NCCAM

The NCCAM Office of Communications is responsible for disseminating CAM
information to the public. Therefore applications addressing database
creation or maintenance, software development, or educational materials
and courses (including CME courses or CD\'s) in general will not be
considered relevant to the NCCAM SBIR/STTR program. Also not eligible
for support are applications seeking to develop cookbooks for special
diets or instructional materials for clinical practice. NCCAM does not
fund clinical practice other than as a component of funded clinical
research.

[]{#__RefHeading___Toc219687179 .anchor}Other Research Topic(s) Within
the Mission of the Center

For additional information on research topics, please contact:

Dr. Carol Pontzer

Program Officer

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___Toc219687180 .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

Summary

Priority Populations: Minorities, Low-Income, and Rural

Diseases where significant health disparities exist: Infant Mortality,
Obesity, Depression, Cancer, Heart Disease, Diabetes, Sexually
Transmitted Infections, and HIV/AIDS

Interventions that address: Behavioral Change, Prevention, Social
Determinants of Health, and Health Literacy

Proposals that are: Transformational, Trans-disciplinary, and
Translational

[]{#__RefHeading___Toc219687181 .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___Toc219687182 .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___Toc219687183 .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___Toc219687184 .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:

Ms. Priscilla Grant, J.D., C.R.A.

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: <pg38h@nih.gov>

[]{#__RefHeading___Toc219687185 .anchor}National Library of Medicine
(NLM)

The National Library of Medicine (NLM) offers support for research and
development projects in biomedical informatics. NLM defines
biomedical informatics as the science of optimal organization,
management, presentation and utilization of information relevant to
medicine and biology. The informatics projects of interest to NLM
involve the application of computer and information sciences to
information problems in a biomedical domain. For additional information
about areas of interest to NLM and a listing of NLM funded applications,
please visit <http://www.nlm.nih.gov/ep>. Business concerns interested
in exploring SBIR/STTR grant opportunities with NLM are encouraged to
contact the NLM representatives prior to submitting an application.

NLM's SBIR/STTR grant programs are focused on areas of particular
interest from small business. The following narrative indicates the
scope of projects suitable for the SBIR/STTR program that fit within the
mission of NLM. They are not listed in priority order.

A. Explore the use of Semantic Web technologies to improve information
retrieval, knowledge discovery, and management model for integrative
biomedical informatics.

B. Information retrieval system that uses an intelligent search agent in
the biomedical domain for biological discovery and clinical decision
support.

[]{#__RefHeading___Toc219687186 .anchor}Other Research Topic(s) Within
the Mission of the Center

For additional information on research topics, contact:

Dr. Jane Ye

Program Officer

Division of Extramural Programs

National Library of Medicine

301-594-4882, Fax: 301-402-2952

Email: <yej@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___Toc219687187 .anchor}CENTERS FOR DISEASE CONTROL AND
PREVENTION (CDC)

CDC will accept SBIR grant applications on the April 5, August 5, and
December 5, 2009 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/).

Questions of a general nature about the CDC SBIR program should be
directed to:

Dr. Juliana Cyril

Centers for Disease Control and Prevention

Office of the Chief Science Officer (OCSO)

Office of Public Health Research (OPHR)

1600 Clifton Road NE, Mailstop D-72

Atlanta, GA 30333

404-639-4639; Fax: 404-639-4903

Email: <jcyril@cdc.gov>

[]{#__RefHeading___Toc219687188 .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 non-occupational
injury, addressing both intentional injuries that result from violent
and abusive behavior and unintentional injuries. The national program
encompasses the prevention of non-occupational 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 scientifically based.

CDC is committed to achieving the health promotion and disease
prevention objectives of \"Healthy People 2010\"
([http://www.cdc.gov/nchs/hphome.htm#Healthy%20People%202010](http://www.cdc.gov/nchs/hphome.htm#Healthy People 2010)),
a Department of Health and Human Services (DHHS)-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.

The National Center for Injury Prevention and Control at CDC published
its CDC Injury Research Agenda, (June 2002), currently being updated,
which identifies 95 research themes in various areas of injury research,
including preventing injuries at home, 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, acute care, disability and
rehabilitation. The full report is available at
<http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm>.

Research Areas of Interest

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 (prevention, acute
care, and rehabilitation). 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
violence 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\. Improve technology transfer of effective interventions to increase
the likelihood of preventing unintentional injuries related to older
adult falls, fires, and teen traffic crashes, and alcohol-related
injuries.

2\. Develop a practical, valid tool to measure the effectiveness of
back-up cameras in preventing backover-related injuries.

3\. Develop technology-based methods to obtain exposure and injury
incidence data for unintentional poisonings, and injuries from sport and
recreational activities.

4\. Improve the effectiveness of existing or proposed engineering
controls (including retrofit solutions) to reduce pedestrian injuries in
unsignaled intersections.

5\. Develop environmental and behavioral devices that can assist in the
prevention of young and older driver crashes, including technology-based
strategies to detect fatigue, drowsiness, distraction, impaired decision
making, slowed reaction time, and devices that provide feedback to
drivers about impending hazards.

6\. Develop technology to improve technology transfer of effective
interventions to prevent violence.

7\. Design, develop, and evaluate educational materials to train public
health personnel in injury prevention that could be adapted for public
health, medicine, nursing and allied health professions.

8\. Develop and evaluate injury and violence prevention materials
uniquely targeted to and disseminated in medical care and managed care
settings, such as computer-assisted risk assessments, clinical-
preventive- services-based interventions, or distance-based learning
technology. These materials can address topics such as falls, alcohol
use, helmet use, poisoning, prevention of youth violence or intimate
partner violence.

9\. Develop and test a device to passively measure the blood alcohol
level of injured patients before they arrive in emergency department or
hospital.

10\. Develop products to improve monitoring and control of exposure to
violent media.

11\. Develop innovative educational products to teach non violent
resolution of conflicts in partner or family situations.

12\. 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.

13\. Develop surveillance tools to capture treatable injuries that occur
on federal and non-federal recreation sites and parks, that can be used
by governments, local jurisdictions, parks and recreation departments,
schools, and outdoor recreation programs.

14\. Develop computer software to assist states in determining the
medical costs associated with treating injuries related to fires, falls,
motor vehicle crashes, poisonings, sports injuries and other
unintentional injuries.

15\. Develop a tool to assess the relative risks of motor vehicle travel
vs. other forms of transportation in the built-environment (e.g. bus,
walking, mass transit) that can be used by urban planners, engineers,
and risk managers, and that can model injury risks and outcomes when
changing from one mode of travel (e.g. driving a vehicle) to another
mode (e.g. walking, bicycling). The tool must account for changing
patterns of traffic mix, risk per exposure by distance, trip, and mode,
and assess the relative benefits vs. harms from changing modes of travel
in differing built-environment settings.

B. ***[Acute Care, Injury Response, and Emergency
Medicine.]{.underline}***

1\. Develop age-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 a 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.

4\. Translate the military injury care advances to the civilian sector.
Examples include, but are not limited to equipment (e.g.,
miniaturization of monitoring devices), devices (e.g., tourniquets),
supplies (dressings), and drugs (hemostatic agents, antibiotics).

5\. Develop lower cost, highly effective equipment, supplies,
therapeutics, or ambulances. Applicants should refer to the WHO
documents, *Prehospital Trauma Care* and *Hospital Trauma Care* for
background describing guidelines for low and middle-income countries.
Additional resource material is the World Health Assembly's resolution
on Emergency Care Systems passed in May 2007.

6\. Develop or adapt equipment, supplies, therapeutics or ambulances for
the care of the trauma patient in low and middle income countries, given
the increasing burden of injuries in these countries.

7\. Develop training materials to assist persons with disabilities and
their caregivers to safely and efficiently evacuate various buildings
(e.g., multi-storied structures) in emergencies.

8\. Pre-Hospital Transport Vehicle for the Acutely Injured. The
management of injuries and trauma related morbidity during a public
health emergency is a significant aspect in preparedness planning. In
many cases those at greatest risk from injuries are the young or those
with limited economic and social support systems. In addition to the
scarcity of resources, such as may occur in rural settings, several
factors may contribute to the difficulty in managing injuries during an
event including:

-   Remote locations with poor communication

-   Traffic congestion

-   Poor road infrastructure and access

-   Lack of trained personnel

-   Lack of appropriate equipment and supplies

-   Deficiencies in ability to deliver timely definitive care

In these settings, effective public health interventions that are both
economically and technically feasible will become increasingly important
in mitigating the severe public health impacts of injuries, especially
during an emergency event.

There is a need to develop pre-hospital transport capability
(ambulances) specifically designed for application in such settings. The
WHO, with support from CDC, led the development of trauma and emergency
care systems that are applicable for conditions in an emergency event.
WHO published Pre-hospital Trauma Care Systems and Guidelines for
Essential Trauma Care to support the development and use of these
systems internationally. A critical component in the care of the acutely
ill or injured patient is timely transport to definitive care facilities
under the challenging circumstances often encountered during various
emergency events.

For use in these situations, the vehicle design process needs to take
into account the following desired characteristics:

-   Low manufacturing cost

-   Low maintenance and fuel costs

-   Capable of moving on paved and non-paved surfaces

-   Capable of navigating narrow passages

-   Warning devices and capability for poor weather use

-   Seats with seatbelts for a driver, care provider

-   Capable of securing a stretcher or having a padded bench with
    seatbelts for a patient to be able to lie flat

-   Capable of securely carrying necessary equipment and supplies for
    the proposed level of care to be provided (e.g. as outlined in
    Pre-hospital Trauma Care Systems).

C. ***[Rehabilitation.]{.underline}***

1\. Develop age-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 and their families
and/or caregivers that are directed toward preventing or minimizing the
secondary complications associated with these injuries.

[]{#__RefHeading___Toc219687189 .anchor}Other Research Topic(s) Within
the Mission of the Center

Develop and validate the effectiveness of a theory-based,
evidence-driver, driver education and training program that could be
implemented by driver education instructors, driver education schools,
public and private schools, or implemented by departments of motor
vehicles.

For programmatic information, contact:

Dr. Paul Smutz

Centers for Disease Control and Prevention

National Center for Injury Prevention and Control

Office of the Associate Director for Science

Mail Stop F-62

4770 Buford Highway, N.E.

Atlanta, Georgia 30341-3724

\(770\) 488-1508, Fax: (770) 488-1665

Email: <wsmutz@cdc.gov>

For grants specific, administrative information, contact:

Ms. Tracey Coleman

Centers for Disease Control and Prevention

Procurement and Grants Office

Mail Stop K-70

2920 Brandywine Road

Atlanta, Georgia 30341

\(770\) 488-2074, Fax: (770) 488-2670

Email: <apf4@cdc.gov>

[]{#__RefHeading___Toc219687190 .anchor}National Center for Health
Statistics (NCHS)

The NCHS conducts and supports statistical and epidemiological
activities for the purpose of improving the effectiveness, efficiency,
and quality of health services in the United States. This includes
collecting statistics on the extent and nature of illness and disability
of the population, as well as life expectancy, incidence of various
acute and chronic illnesses, and infant and maternal morbidity and
mortality; impact of illness and disability of the population on the
economy of the U.S. and on other aspects of the well-being of its
population; environmental, social, and other health hazards;
determinants of health; health resources, including physicians,
dentists, nurses, and other health professionals, by specialty and type
of practice and the supply of services by hospitals, extended care
facilities, home health agencies, and other health institutions;
utilization of health care, both ambulatory health services and services
of hospitals, extended care facilities, home health agencies, and other
institutions; health care costs and financing, including trends in
health care prices and cost, sources of payments for health care
services, and Federal, State, and local governmental expenditures for
health care services; family formation, growth, and dissolution. It also
undertakes and supports research, demonstrations, and evaluations of new
or improved methods for obtaining current data on matters pertaining to
its mission.

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

1\) The development and refinement of innovative techniques for
measurement of biomarkers in survey research conducted in households or
other non-clinical settings including the collection of biological
specimens such as urine or blood, measuring heart rate, or measuring
senses;

2\) The development of kits for collecting biomarkers that can be used
in survey research conducted in households or other non-clinical
settings;

3\) The validation of biomarkers collected via nontraditional measures,
such as filter paper and saliva, with those collected using traditional
measurement techniques;

4\) The development and refinement of summary measures of health
including measurement of functioning and disability;

5\) The development and improvement of sampling strategies for
subpopulations of interest including minority populations, people with
specific rare diseases or conditions, specific socioeconomic statuses,
or people with only cell phones;

6\) The development and improvement of techniques to avoid disclosure of
confidential data in public use data including tabular data, microdata,
web-based query and regression servers, and secure distributed
statistical analysis;

7\) The development and validation of improved diary methods to record
data such as short term contraceptive use, intercourse, pregnancy
outcomes, cohabitation and other health-related behaviors;

8\) The development of improved training techniques and programs for
collection of birth certificate data in hospitals;

9\) In conjunction with state registrars, the development of a process
for evaluating Electronic Birth Registration System (EBRS) Software and
associated work sheets;

10\) The evaluation of current methods and development of improved
measures and methods of data collection for "date of last normal menses"
(LMP), and other factors associated with preterm birth and low birth
weight, especially as collected on birth certificates;

11\) The development and evaluation of a process and procedures for
validating data from birth certificates using the 2003 revision:

12\) A feasibility study of the "bridging" of data from the 1989 and
2003 revisions of the birth certificate.

For programmatic information, contact:

Dr. Virginia S. Cain

Director of Extramural Research

National Center for Health Statistics

Centers for Disease Control and Prevention

301-458-4395, Fax: 301-458-4020

Email: <vcain@cdc.gov>

For grants specific, administrative information, contact:

Ms. Nealean Austin

770-488-2771, Fax: 770-488-2777

Email: <nea1@cdc.gov>

[]{#__RefHeading___Toc219687191 .anchor}National Center for Public
Health Informatics (NCPHI)

The NCPHI protects and improves the public's health through discovery,
innovation, and service in health information technology and
informatics. Informatics can be defined as the collection,
classification, storage, retrieval, and dissemination of recorded
knowledge. Public health informatics can be defined as the systematic
application of information and computer science and technology to public
health practice, research and learning. NCPHI assumes a leadership role
for CDC in public health informatics and health information technology;
ensures progress on CDC information resources, informatics, and health
information systems and standards; facilitate cross-national center
collaboration on informatics and health information projects; and
advances and supports health information and informatics initiatives,
systems, and activities across public health.

The NCPHI serves to strengthen and support the detection, monitoring,
analysis, alerting, communication, response, and resourcing of vital
public health information. NCPHI provides leadership in establishing and
ensuring security and reliability standards for all CDC data, and
provides systems interoperability standards to essential CDC information
technology resources.

NCPHI Home Page: <http://www.cdc.gov/ncphi/>

Research areas of interest:

NCPHI would be interested in funding research from small businesses on
the following topics:

A. Research and development on systems (such as software) that link
public health with health information exchange initiatives and provide
real time views on the health of communities. Systems could explore a
variety of issues such as:

1\. Real time surveillance of the health of the healthcare system based
on assessment of functioning of the system (hospital bed capacity, etc.)
as described in the AHIC bioterrorism use case.

2\. Real time surveillance of chronic health conditions including
diabetes, cardiovascular disease, asthma, lung disease, and cancer with
linkages to geographic information systems and databases of environment
exposures.

B. Research and development on systems (software) that use unobtrusive
strategies to tailor web sites to individual learning styles to enhance
the uptake of health information and increase the propensity of
individuals to undertake positive health behavior change.

C. Research and development of innovative platforms, applications and/or
approaches that support the integration of electronic personal health
records or electronic personal health information management systems
with smart decision-support tools that help people become more engaged
in and improve their health and/or manage existing conditions.

Broad areas of topical interest include, but are not limited to, family
health and wellness, health and the environment and personal health
benchmarking.

Special consideration will be given to those proposals that emphasize
innovation or translation of research into practice, and also to
proposals that have potential demonstrable public health impact.

For technical information on research contact:

Lee Husting, Ph.D. MPH

Scientific Program Officer

Office of the Director, MS E-78

National Center for Public Health Informatics

Coordinating Center for Health Information and Service

Centers for Disease Control and Prevention

404-498-1186

Email: <eih8@cdc.gov>

For grant specific information contact:

Ms. Nealean Austin

770-488-2771, Fax: 770-488-2777

Email: <nea1@cdc.gov>

[]{#__RefHeading___Toc219687192 .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.

For programmatic information, contact:

Brenda Colley Gilbert, Ph.D., MSPH

Director, Extramural Research Program Office

Coordinating Center for Health Promotion

Centers for Disease Control and Prevention

Mail Stop K-92

4770 Buford Highway, NE Atlanta, GA 30341

770-488-8390, Fax: 770-488-8046

Email: <bjc4@cdc.gov>

or

Shelia Jones

Public Health Analyst

Coordinating Center for Health Promotion

Centers for Disease Control and Prevention

Mail Stop K-92

4770 Buford Highway, NE Atlanta, GA 3034blic

770-488-6426 Fax: 770-488-8046

Email: <slj1@cdc.gov>

For grants specific, administrative information, contact:

Hector A. Buitrago

Team Leader/Grants Management Officer

Procurement and Grants Office (PGO) - Branch III

Centers for Disease Control and Prevention

2920 Brandywine Road

MS E-09

Atlanta, GA 30341-4146

770-488-2921, Fax: 770-488-2777

Email: HBuitrago@cdc.gov

[]{#__RefHeading___Toc219687193 .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 the
publication *[Setting the Agenda: CDC Research in Chronic Disease
Prevention and Health Promotion]{.underline}*.

For programmatic information, contact:

Brenda Colley Gilbert, Ph.D., MSPH

Director, Extramural Research Program Office

Coordinating Center for Health Promotion

Centers for Disease Control and Prevention

Mail Stop K-92

4770 Buford Highway, NE Atlanta, GA 30341

770-488-8390, Fax: 770-488-8046

Email: <bjc4@cdc.gov>

or

Shelia Jones

Public Health Analyst

Coordinating Center for Health Promotion

Centers for Disease Control and Prevention

Mail Stop K-92

4770 Buford Highway, NE Atlanta, GA 3034blic

770-488-6426 Fax: 770-488-8046

Email: <slj1@cdc.gov>

For grants specific, administrative information, contact:

Hector A. Buitrago

Team Leader/Grants Management Officer

Procurement and Grants Office (PGO) - Branch III

Centers for Disease Control and Prevention

2920 Brandywine Road

MS E-09

Atlanta, GA 30341-4146

770-488-2921, Fax: 770-488-2777

Email: HBuitrago@cdc.gov

[]{#__RefHeading___Toc219687194 .anchor}Division of Adult and Community
Health

The mission of the Division of Adult and Community Health (DACH) has
four 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\. ***[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.

4\. ***[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

National Center for Chronic Disease Prevention and Health Promotion

Mail Stop K-45

Atlanta, GA 30341

770-488-5269, Fax: 770-488-5964

Email: <mnw1@cdc.gov>

[]{#__RefHeading___Toc219687195 .anchor}Division of Cancer Prevention
and Control

The Division of Cancer Prevention and Control (DCPC) supports
comprehensive cancer surveillance, epidemiologic, health and behavioral
science research, communications and program services to reduce the
illness and death associated with cancer. The mission of DCPC is:

-   To plan, direct, and support cancer control efforts through
    collaborations with prevention partners in state health agencies,
    federal agencies, academic institutions, and national, voluntary,
    and private sector organizations.

-   To direct, monitor, and report on activities associated with the
    implementation of the Breast and Cervical Cancer Mortality
    Prevention Act of 1990, Public Law 101-354 ([1998 Code
    PDF-56KB](http://www.cdc.gov/cancer/nbccedp/bccpdfs/uscodebc98.pdf)),
    and the Cancer Registries Amendment Act, Public Law 102-515 ([1998
    Code
    PDF-36KB](http://www.cdc.gov/cancer/npcr/npcrpdfs/publawnpcr98.pdf)).

-   To plan and conduct epidemiological studies and evaluations to
    identify the feasibility and effectiveness of cancer prevention and
    control strategies. DCPC provides state and local public health
    agencies and other health care provider organizations with technical
    consultation and assistance to improve education, training, and
    skills in the prevention, detection, and control of selected
    cancers.

-   To identify problems, needs, and opportunities related to modifiable
    behavioral and other risk factors. The division also recommends
    priorities for health promotion, health education, and cancer risk
    reduction activities both for professionals and the public. DCPC
    pursues the building of local coalitions and community networks and
    the implementation of grassroots activities to reach the target
    populations of persons at increased risk for developing cancer.

Areas of Interest

-   Increasing the effectiveness of cancer prevention and control
    activities nationwide by enhancing the Division's relationships with
    partners and policy makers

-   Expanding the use of information technology in cancer surveillance,
    particularly through the use of electronic reporting to cancer
    registries.

-   Improving the cost-effectiveness of the National Breast and Cervical
    Cancer Early Detection Program.

-   Expanding CDC\'s focus to include malignancies not previously
    addressed, such as lung cancer and malignancies of the head and
    neck.

-   Defining the proper role for management of chronic diseases,
    including cancer, in the case of catastrophic disaster.

For programmatic information, contact:

Robert German, PhD

Associate Director for Science

Division of Cancer Prevention and Control

National Center for Chronic Disease Prevention and Health Promotion

Mail Stop K-52

Atlanta, GA 30341

770-488-4226, Fax: 770-488-4760

Email: <rjc5@cdc.gov>.

[]{#__RefHeading___Toc219687196 .anchor}Office on Smoking and Health

The Office on Smoking and Health (OSH) is responsible for leading and
coordinating strategic efforts aimed at preventing tobacco use among
youth, promoting smoking cessation among youth and adults, protecting
nonsmokers from environmental tobacco smoke (ETS), and eliminating
tobacco-related health disparities.

OSH has identified two research areas for which proposals are requested:

Office on Smoking and Health and Division of Nutrition, Physical
Activity, and Obesity

Tools to Promote Physical Activity and Healthy Eating via Tobacco
Cessation Quitlines

1\. Develop and test tools for use by tobacco cessation quitline
counselors in counseling callers to increase physical activity and
healthy eating. The tools should employ the following formats --
specific modules for use by telephone counselors, automated telephone
prompts, web-based tools for the caller to use on their own or with
facilitated help, instant messaging reminders systems, and CDs.

-   Tools should be targeted and developed for callers in various stages
    of behavioral change for increased physical activity and healthy
    eating -- pre-contemplation, contemplation, action, and maintenance.

-   Special emphasis should be given to developing tools that can be
    used with high risk or underserved populations.

2\. Propose strategies for effective utilization of the tools among the
practitioners and quitline callers.

3\. Propose a plan for distribution of final product(s) to practitioners
and quitline callers.

Telephone-based tobacco cessation services are available toll-free in
every state through the 1-800-Quit Now national number. To date, over 1
million calls have been made to the national number. Smokers tend to
weigh less than nonsmokers; however, the majority of smokers who quit
gain weight. Most will gain fewer than 10 lbs., but there is a broad
range of weight gain, with as many as 10 percent of quitters gaining as
much as 30 lbs. Women, African Americans, people under age 55 and heavy
smokers are more likely to have major weight gain. The 2008 PHS
guidelines for treating tobacco use and dependence recommend that
clinicians should encourage patients to maintain or increase their
engagement in moderate exercise and in eating plenty of fruits and
vegetables. They also should offer to help their patients address weight
gain once the patient has successfully quit smoking. There is no
evidence to date that interventions to increase exercise or mitigate
weight gain during attempts to stop smoking reliably boost smoking
abstinence rates or reduce weight gain. There is also no evidence that
these interventions undermine success in stopping smoking. Brief
telephone prompts appear to be effective increasing walking behaviors;
little research to date is available on the effectiveness of telephone
counseling for healthy eating. Quitlines offer an opportunity to
incorporate messages on increasing physical activity and healthy eating
among a large population of persons at high risk for chronic diseases.
Key messages on healthy eating for incorporation into public programs
are summarized on the Division of Nutrition, Physical Activity, and
Obesity's Weight Management Research to Practice Series website
(<http://www.cdc.gov/nccdphp/dnpa/nutrition/health_professionals/practice/index.htm>).

This initiative supports CDC's Health Protection Goals of healthy people
in the adult, older adults, and seniors life stages; to help them live
healthy productive and satisfying lives and live longer and better.

[]{#__RefHeading___Toc219687197 .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. DOH 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.

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 and evaluate tools and models for screening dental patients
for infectious and chronic diseases.

3\. Develop methods or models for evaluating the effectiveness and
cost-effectiveness of infection control interventions.

4\. Develop dental devices with passive safety features that meet or
exceed performance criteria identified by CDC
([www.cdc.gov/oralhealth/infectioncontrol/forms.htm](http://www.cdc.gov/oralhealth/infectioncontrol/forms.htm)).

5\. Develop devices, both accurate and passive, to measure biofilm or
bacterial contamination in dental waterlines.

6\. Develop educational/training materials and demonstrate their
effectiveness in on-the-job training of dental assistants in dental
office infection control and quality assurance.

7\. Develop and evaluate 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.

Oral Health

In collaboration with several partners, the DOH 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 methods/technologies to assist in the collection and
analysis of data to estimate the effectiveness and cost effectiveness of
community/school programs delivering interventions to prevent 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 programmatic information, contact:

Jennifer L. Cleveland, D.D.S., M.P.H.

Dental Officer/Epidemiologist

Division of Oral Health

National Center for Chronic Disease Prevention and Health Promotion

Mail Stop F-10

Atlanta, GA 30341

\(770\) 488-6066, Fax: (770) 488-6080

Email: <JLCleveland@cdc.gov>

[]{#__RefHeading___Toc219687198 .anchor}Division of Reproductive Health

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

For programmatic information, contact:

Sam Posner, PhD, MA

Associate Director of Science and Lead Health Scientist

Division of Reproductive Health

National Center for Chronic Disease Prevention and Health Promotion

Mail Stop K-20

Atlanta, GA 30341

\(770\) 488-5200, Fax: (770) 488-6450

Email: <shp5@cdc.gov>

[]{#__RefHeading___Toc219687199 .anchor}Division for Heart Disease and
Stroke Prevention

Heart disease and stroke are the first and third leading killers of
Americans and are leading causes of disability in the US. The Division
for Heart Disease and Stroke Prevention (DHDSP) currently funds health
departments in 32 states and the District of Columbia to develop,
implement, and evaluate programs that promote heart--healthy and
stroke--free communities; prevent and control heart disease, stroke, and
their risk factors; and eliminate disparities among populations. These
programs emphasize the use of education, policies, environmental
strategies, and systems changes to address heart disease and stroke in
various settings and to ensure quality of care.

The DHDSP houses CDC\'s WISEWOMAN program. With 15 projects in 14
states, WISEWOMAN helps women with little or no health insurance gain
access to screening and lifestyle interventions that can reduce their
risk of heart disease, stroke, and other chronic diseases.

Program priorities of DHDSP focus on high blood pressure control; high
cholesterol control; knowing the signs and symptoms of heart attack and
stroke and need to call 911; improving emergency response; improving
quality of care; and eliminating gender, racial/ethnic, and geographic
health disparities.

For programmatic information, contact:

Judy Hannan, RN, MPH

Deputy Director

Division of Heart Disease and Stroke Prevention

National Center for Chronic Disease Prevention and Health Promotion

Mail Stop K-47

Atlanta, GA 30341

\(770\) 488-2424, Fax: (770) 488-8151

Email: <jhannan@cdc.gov>

[]{#__RefHeading___Toc219687200 .anchor}National Institute for
Occupational Safety and Health (NIOSH)

The NIOSH plans, directs and coordinates the national program effort to
develop and recommend occupational safety and health standards, and to
conduct research, training, and related activities to assure safe and
healthful working conditions for every working person. NIOSH has both a
regular research 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 research 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; demonstration research to evaluate
the technical feasibility or application of a new or improved
occupational safety and health procedure, method, technique, or system;
and translation research that focuses on disseminating proven
interventions, controls, methods and systems into the workplace.

NIOSH adheres strictly to the following funding levels:

Phase I awards may not exceed \$100,000 total for a period normally not
to exceed 6 months.

Phase II awards may not exceed \$750,000 total for a period normally not
to exceed 2 years.

Research Objectives

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.

E. Develop alternatives to pesticide application and hazardous waste
remediation.

F. Develop micro sensing devices to notify workers before chemicals
break through protective clothing and identify failures in containment
systems for hazardous materials.

G. Develop new materials for clothing to protect against chemical and
physical hazards.

H. Develop information dissemination methods to help businesses learn
about and implement occupational safety and health programs.

I. 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.

Construction

Each day, construction workers face injury hazards from falls, machines,
electricity, motor vehicles, and other equipment and circumstances.
Health hazards posed by construction work can include dusts, fumes,
noise, and chemicals. Musculoskeletal disorders can arise from excessive
exertion of force, working in awkward positions, repetitive motions,
exposure to vibrating power tools, environmental extremes, and other
physical and organizational risk factors. NIOSH researchers identify
causes of and develop programs and solutions to prevent injuries and
fatalities in construction. NIOSH and construction stakeholders have
identified fifteen strategic goals identifying specific needs. These are
available at <http://wwwdev.niosh.cdc.gov/niosh/nora/default.html> and
they provide additional ideas for innovation research. Some examples of
innovation needs include:

A. Development of new designs or controls to reduce various hazards such
as noise, vibration, dust emissions, welding fumes, high force exertion,
or awkward postures.

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) and implementation of precautions on job
sites.

D. Development of design approaches for prevention or minimization of
hazards and commercialization of these interventions to help get them
into use.

E. Development of engineering interventions that reduce fall,
electrical, overexertion, or struck-by hazards and commercialization of
these interventions to help get them into use.

Agriculture, Forestry, and Fishing

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
with regards to health and safety. Miners must deal with adverse natural
conditions while working in restricted spaces with limited visibility.
The industry also deals with a variety of unknown conditions, including
the physical characteristics of the material being mined as well as the
surrounding strata which ultimately form the mine complex. All health
and safety topics for the mining industry are eligible for
consideration. Some example topics include exposure of mine workers to
diesel exhaust, hearing loss prevention in miners, reduction of injuries
from materials handling, reduction of injuries and fatalities from
powered-haulage equipment, controlling coal and silica dusts, prevention
of musculoskeletal disorders, health and safety during construction and
maintenance operations, control of chemical hazards and toxic
substances, assessment of intervention effectiveness, and dissemination
of proven interventions into the mining workplace. The chief requirement
for all projects is a focus on reducing the risks of injuries and
illnesses directly related to working in a mining environment.
Advancements in technology and knowledge which address any of the above
concerns would be beneficial to improving mine-worker health and safety.
The advancements could be achieved through developing new and innovative
technologies, enhanced understanding of the working environment, and
improved approaches and strategies for dealing with the issues.

A. Develop new approaches, technologies, or strategies for dealing with
excessive exposures in the mining environment.

B. Develop new approaches, technologies, or strategies for assisting in
mine escape and/or mine rescue operations. Particular interest is for
underground coal mines.

C. Determine the effectiveness and/or development of improved approaches
for training used to protect the health and safety of mine workers.

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.

Healthcare and Social Assistance (HCSA)

Workers are at risk for illness and injuries because of long hours,
changing shifts, physically demanding tasks, violence, and exposures to
infectious diseases and hazardous chemicals. The HCSA sector comprises
workplaces providing health care and social assistance for individuals.
The industries in this sector are arranged on a continuum starting with
those workplaces providing medical care exclusively, continuing with
those providing health care and social assistance, and finally finishing
with those providing only social assistance. The services provided by
workplaces in this sector are delivered by trained professionals. Many
of the industries in the sector are defined based on the educational
degree held by the practitioners. Emerging issues identified include:
stress from chronic understaffing and long hours due to shortages in
nursing and other health care professions; an aging workforce of nurses
and other HCSA workers, in the face of increasing demand; potential
exposures to unknown hazardous agents contaminating emergency
responders; emerging infectious diseases such as SARS and avian
influenza; exposure to a variety of antibiotic-resistant pathogens; risk
from a dramatic increase in workplace violence perpetrated by clients,
their families, and co-workers; and hazardous chemical use and the
exposure to potentially hazardous new technologies which are
continuously being introduced into healthcare settings.

A. Identify an emerging issue or an existing issue and develop
technology to measure or predict exposure of HCSA workers present in
workplaces providing health care and social assistance for individuals.

B. Determine the effectiveness and/or develop improved approaches for
training used to protect HCSA workers.

C. Develop information tools to facilitate hazard recognition.

Manufacturing

The Manufacturing sector includes workplaces engaged in the mechanical,
physical, or chemical transformation of materials, substances, or
components into new products. The assembling of component parts of
manufactured products is also considered manufacturing, except in cases
where the activity is appropriately classified as Construction [North
American Industry Classification System (NAICS) Web
site](http://www.census.gov/epcd/www/naics.html) (Cocode 31-33, Sector
23). Workplaces in the Manufacturing sector are often described as
plants, factories, or mills and characteristically use power-driven
machines and materials-handling equipment.

The Manufacturing sector includes industries that manufacture durable
and non-durable goods including food and food products, beverage and
tobacco products, textiles and textile products, apparel, leather and
allied products, wood products, paper and paper products, printing and
related support activities, petroleum and coal products, chemicals,
plastics and rubber products, nonmetallic mineral products, primary
metals and fabricated metal products, machinery, computer and electronic
products, electrical equipment, appliances and components,
transportation equipment, furniture and related products, medical
equipment, jewelry, sporting goods, toys, office supplies, signage, and
other products. Manufacturing workplaces may process materials or may
contract with other workplaces to process their materials for them. Both
types of workplaces are included in manufacturing.

A. Identify an emerging issue or an existing issue and develop
technology to measure or predict exposure of manufacturing workers
present in workplaces engaged in the mechanical, physical, or chemical
transformation of materials, substances, or components into new
products.

B. Determine the effectiveness and/or develop improved approaches for
training used to protect manufacturing workers.

C. Develop information tools to facilitate hazard recognition.

Public and Private Services

This sector includes workers in the following fields: information and
publishing industries; finance and insurance; real estate; professional,
scientific, and technical services; management; education; arts,
entertainment, and recreation; accommodation and food services; repair
services; personal services; and public administration.

Emerging issues in the services sector include Infectious disease such
as Avian influenza and SARS may place workers in the hospitality
industry at risk as they make contact with travelers and their discarded
materials; Needle stick injuries are increasing outside medical clinics
and hospitals. More and more patients are injecting medications for
diabetes, arthritis and other common ailments at home. Needles from
illicit drug use also get placed in domestic solid waste. Workers in
waste handling, hospitality, and housekeeping experience increased
injury and infection risks as they handle contaminated discarded
needles; Wireless technology is changing the locations where work can be
completed especially for information industries. Miniaturization of some
electronic devices may result in increased musculoskeletal disorders and
in hearing loss with long-term use; Ergonomic interventions have reduced
muscle strain from lifting but have increased the loads that are pushed
or pulled by workers. These new job demands may have long-term health
risks that have yet to be recognized; Violence is an increasing risk for
many in the service sector, especially those in public safety and food
and alcohol service; and, Work Organization changes have led to
increasing responsibilities with less control over work factors in many
industries and jobs. Increased reliance on electronic measures has
created productivity pressures on workers in the information sector.

A. Identify an emerging issue or an existing issue and develop
technology to measure or predict exposure of Public and Private Services
workers present in workplaces potentially exposed to infectious disease,
needle sticks, muscle strain, or violence.

B. Determine the effectiveness and/or develop improved approaches for
training used to protect Public and Private Services workers.

C. Develop information tools to facilitate hazard recognition.

Transportation, Warehousing and Utilities

Transportation and Warehousing includes industries providing
transportation of passengers and cargo, warehousing and storage for
goods, scenic and sightseeing transportation, and support activities
related to modes of transportation. Establishments in these industries
use transportation equipment or transportation related facilities as a
productive asset. The type of equipment depends on the mode of
transportation. The modes of transportation are air, rail, water, road,
and pipeline. Utilities is comprised of establishments engaged in the
provision of the following utility services: electric power, natural
gas, steam supply, water supply, and sewage removal.

A. Identify an emerging issue or an existing issue and develop
technology to measure or predict exposure of Transportation, Warehousing
and Utilities workers engaged in activities that may cause
musculoskeletal disorders. Intervention effectiveness projects regarding
obesity or sleep disorders in truckers will also be welcomed.

B. Determine the effectiveness and/or develop improved approaches for
training used to protect Transportation, Warehousing and Utilities
workers.

C. Develop information tools to facilitate hazard recognition.

Wholesale and Retail Trade

This sector includes both wholesale and retail trade. Both wholesale and
retail trade are comprised of establishments engaged in the sale of
merchandise, generally without transformation, and rendering services
incidental to the sale of merchandise.

Some of the emerging issues include the following: (1) long work hours,
(2) shift work, and (3) work stress from serving the public, either in
direct or telemarketing sales. Health and retirement benefits are
disappearing, which can cause work-related stress in managing illnesses.
Just in time shipping and order filling is increasing causing time
pressure and lack of work control. Psychosocial problems are increasing
that can fuel workplace violence. Musculoskeletal disorders continue to
be a burden to workers, but the stress loads are shifting from the low
back and legs to the upper extremities and shoulders/neck. This is
occurring as a consequence of materials handling equipment reducing the
lifting burdens but increasing the need to use keyboards and monitoring
systems. Researcher will need to be sensitive to low force and high
speed repetitive activities and static postures. It is expected that as
the research agenda for the Wholesale and Retail Trade sector is
developed, more emerging issues will be identified that will require
continuing research.

A. Identify an emerging issue or an existing issue and develop
technology to measure or predict exposure or to measure intervention
effectiveness of wholesale and retail trade workers present in their
workplaces.

B. Determine the effectiveness and/or develop improved approaches for
training used to protect wholesale and retail trade workers.

C. Develop information tools to facilitate hazard recognition.

[]{#__RefHeading___Toc219687201 .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
National Occupational Research Agenda (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>.

For programmatic information, contact:

Ms. Susan Board, MS

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 grants specific, administrative 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___Toc219687202 .anchor}National Center for
Environmental Health (NCEH)

The National Center for Environmental Health (NCEH) plans, directs, and
coordinates a national program to maintain and improve the health of the
American people by promoting a healthy environment and by preventing
premature death and avoidable illness and disability caused by
non-infectious, non-occupational environmental and related factors. The
main activities of NCEH is to provide national leadership, through
science and service in prevention programs, global health, and the use
of human genetic knowledge, and tests. Research topics include, but are
not limited to, those identified below:

A. ***[Environmental Health/Anti-Chemical Terrorism---Rapid Field Tests
for Human Exposure.]{.underline}*** There is a need to develop rapid,
reliable, field rugged methods for detection and quantitative estimation
of human exposure to environmental contaminants and toxic chemical-based
weapons of mass destruction or terrorism. Such methods must be able to
sense the presence or absence of such substances quickly and reliably,
and provide estimations of concentration in human urine, saliva, breath,
blood, or transpired through the skin. Minimums of false positives and
false negatives are important for such technology to avoid wasting
resources and missing actual exposures.

B. ***[Detection of Human Exposure to Aflatoxins and Other Mycotoxins
from Food or as Chemical Warfare or Terrorism Agents.]{.underline}***
Aflatoxins and other mycotoxins are products that naturally occur from
fungi on grains and other food materials. They are produced at harmful
levels under certain weather conditions or during improper storage. They
have the potential to be weaponized as chemical warfare or terrorism
agents. There is a need to develop analytical methods for detection of
these compounds in urine, saliva, or blood in the field to support
epidemiologic investigations or under battlefield conditions. Methods/
instruments must reliably detect and quantify human exposure to these
agents, with limits of detection consistent with background levels in
populations as well as levels in exposed persons.

C. ***[Rapid Field Tests or Continuous Monitors for Arsenic in Drinking
Water.]{.underline}*** Drinking water with toxic levels of naturally
occurring arsenic obtained from shallow wells is a serious problem in
many parts of the world. Recently, this problem has become especially
acute in rural areas of the under-developed world because of efforts to
improve drinking water sources that unfortunately did not fully consider
natural sources of arsenic. The solution requires deep wells, or water
treatment at the point of use. However, because of uncertainty about the
level of arsenic in water from these improved sources, and because of
the need to give attention to the most heavily contaminated existing
shallow wells first, there is a need to develop rapid, reliable, and
cost effective tests or monitors for water arsenic.

D. ***[Rapid Field Tests for Iodine Levels in Urine and
Salt.]{.underline}*** Iodine deficiency is a global problem affecting
millions of people, leading to reduced population IQ, cretinism, goiter,
and contributing to thyroid cancer. To facilitate efforts to eliminate
this problem, rapid, simple, and inexpensive tests are needed that can
determine the concentration of iodine in urine for population screening
work, and that can determine the concentration of iodine in salt samples
for quality control purposes in iodized salt production. While field
tests for iodized salt have been developed in recent years, they have
proven to be inaccurate and unreliable. Tests for urinary iodine
typically have required complicated laboratory procedures. Simple,
reliable measures for field use would be a great help.

E. ***[Coronary Heart Disease.]{.underline}*** The development of a
laboratory technology to standardize and improve the quality and
reliability of laboratory tests for cholesterol and other metabolically
related lipids and lipoproteins that are known risk factors associated
with coronary heart disease is an area that needs improvement of
diagnostic techniques. Specifically, the contractor should develop and
characterize improved serum reference materials that can be used by NCEH
to standardize laboratories which conduct epidemiological and lipid
research and clinical trials into the causes and prevention of coronary
heart disease.

F. ***[Rapid Field Tests for Vitamin A Status.]{.underline}*** There is
a need for the development of rapid, rugged field portable, and
economical techniques for determining vitamin A status in finger stick
or earlobe blood samples collected by microcapillary techniques or on
filter paper. Methods may be based on fluorescence, optical density, or
any other technique which reliably estimates vitamin A status in humans,
but it should correlate to widely accepted \"reference\" methods such as
high performance liquid chromatography (HPLC). Such methods would be
highly valuable in global efforts to eliminate vitamin A deficiency, a
high priority for WHO, UNICEF, USAID, and many other international
agencies. Vitamin A deficiency is a devastating problem especially in
developing countries where it contributes significantly to childhood
morbidity and mortality, and is a leading cause of blindness in many
parts of the world.

G. ***[Rapid and Reliable Field Tests for Serum Ferritin and Transferrin
Receptor.]{.underline}*** Iron deficiency and iron deficiency anemia are
serious problems throughout the developing world and in many high-risk
groups in developed countries, including the United States. These
problems negatively impact societies by reducing work capacity,
impairing mental development and learning, and increasing morbidity and
mortality, especially in women of child bearing age and young children.
There is a need to develop reliable, easy to operate, and cost effective
devices for screening for serum ferritin, and if possible for serum
transferring receptor in populations and for managing individuals
receiving iron intervention treatments. These devices would have to
operate properly in climatic conditions that are not always regulated.
Portable devices would be desirable. The use of blood collected through
a minimally invasive technique would be preferred.

H. ***[Development of Stable Isotope Labeled Proteins for Quantitation
of Protein Biomarkers.]{.underline}*** Improving the accuracy of
measurements of protein levels in humans is an important step toward a
better understanding of many diseases. The choice of standards is
usually the key for the precision, reproducibility and accuracy of
measurements of different compounds. Isotope dilution mass spectrometry
is widely used for the quantitation of small molecules in biological
specimens. It improves the measurements of low concentrations of
chemicals and biomarkers in such samples so that concentrations can be
correlated to internal dose. The use of isotope dilution mass
spectrometry for the analysis of proteins is less developed due to the
difficulties associated with the synthesis of the isotopically labeled
proteins used as internal standards in this technique. In order to
fulfill this gap, high purity proteins (\>95% purity) are needed in
which stable isotopes are incorporated into the protein. 13C and 15N are
to be incorporated as labeling isotopes instead of 2H or 18O because the
later can sometimes be exchanged during sample processing. Enough number
of labels should be introduced in the protein so they can be analyzed
with a triple quadrupole mass spectrometer and produce meaningful
results. We would like to develop a new project for producing high
purity labeled hemoglobin, albumin and insulin, which will be used as
standards for the quantitation of protein biomarkers.

I. ***[Improved Tests for Zinc Status and Zinc Body Stores in
Humans.]{.underline}*** The essential element zinc has been shown to be
extremely important in human health. Recently it has been especially
important as a cofactor in efforts to combat iron deficiency and vitamin
A deficiency in the developing world. There is a need to develop simple,
reliable, easy to operate, and cost effective methods or instruments for
screening for zinc deficiency in populations and for managing
individuals receiving intervention treatments. There is also a need for
improved approaches to assessing zinc body stores.

J. ***[Improving Assessment of Children\'s Exposure to Toxic
Substances.]{.underline}*** Children tend to be more susceptible to
toxic substances than adults because of a variety of differences related
to physical and functional characteristics. It is imperative that
exposure of children to toxic substances be minimized or eliminated
since exposures could result in subtle effects upon children\'s growth,
maturation, and health. Children are generally at greater risk than
adults for exposure to environmental pollutants from inhalation because
they have a higher respiratory rate; from dermal exposure because they
have more exposed surface area; and from ingestion because they have a
tendency to play in and eat dirt. In order to address children\'s
exposures, the following rapid response technology is needed:

1\. Development of an \"environmental sensor\" that would detect
concentration levels of volatile organic compounds (VOCs) and
particulates at threshold levels that would be harmful to small
children.

2\. Development of a \"soil tester\" that would determine the
concentration level of various trace metals and other environmental
pollutants that might concentrate in soil, where children are likely to
play.

For technical information on research topics, contact:

Paul Mehta, MD

Extramural Research Program Office

NCIPC, NCEH/ATSDR

Centers for Disease Control and Prevention

4770 Buford Highway, MS F62

Atlanta, Georgia 30341

770-488-0556, Fax: 770-488-1665

Email: <pum4@cdc.gov>

For grants specific, administrative information, contact:

Ms. Tracey Coleman

404-488-2074

Email: <apf4@cdc.gov>

[]{#__RefHeading___Toc219687203 .anchor}The Coordinating Center for
Infectious Diseases

The mission of the Coordinating Center for Infectious Diseases (CCID) is
to protect health and enhance the potential for full, satisfying, and
productive living across the lifespan of all people in all communities
related to infectious diseases.

Website: <http://www.cdc.gov/about/organization/ccid.htm>.

[]{#__RefHeading___Toc219687204 .anchor}National Center for HIV/AIDs,
Viral Hepatitis, STD, and TB Prevention (NCHHSTP)

The mission of the National Center for HIV/AIDS, Viral Hepatitis, STD,
and TB Prevention (NCHHSTP) is to maximize public health and safety
nationally and internationally through the elimination, prevention, and
control of disease, disability, and death caused by HIV/AIDS, Viral
Hepatitis, other Sexually Transmitted Diseases, and Tuberculosis.

Website: <http://www.cdc.gov/nchhstp/>

[]{#__RefHeading___Toc219687205 .anchor}Division of HIV/AIDS Prevention

Research Area of Interest

A. ***[Novel Technology and Software Development to Enhance HIV
Prevention, Partner Notification and Medication
Adherence.]{.underline}***

Public health practitioners know that information technology (IT) is
changing the landscape of health care with advanced medical technologies
and electronic medical record systems. Therefore, many uses of IT in
public health are now being sought, including systems to improve health
communication between federal, state and local public health agencies,
bioterrorism and disease surveillance, dissemination of information to
the community and quality assurance programs. However, innovative and
strategic uses of IT beyond public health infrastructure that can
improve our prevention and treatment efforts are still necessary.

In 1999, the San Francisco Department of Health reported an outbreak of
syphilis among gay men who met their sexual partners through an internet
chat room. Because the partners had met in cyberspace, the health
department had limited partner information challenging their existing
models for partner notification and community outreach. In this
instance, public health officials were able to partner with the internet
service provider and use the internet to perform partner notification,
reaching more than 40% of named partners which is much higher than the
8% reached by traditional partner notification. Internet based partner
notification using email and notification cards are becoming popular
means for disease intervention. This is just one example of how
innovative uses of technology can improve our disease prevention
efforts. Public health authorities need to partner with the IT industry
to further develop practical disease prevention tools using new and
advancing technologies for both domestic and global public health.

**Research topic:** Develop software technology for devices that are
commonly available to the public that will support public health efforts
to improve prevention and treatment efforts including of HIV, sexually
transmitted infections, and other communicably diseases.

**Suggested Projects:**

-   Medication Adherence - Develop software for cellular phones that
    remind patients to take medications and prompt pharmacy refill
    requests. Also include the ability to track medication adherence and
    adverse events by recording the data in a database. The goal is to
    improve adherence to medications and potentially decrease the
    forward transmission of infectious diseases.

-   Results Reporting -- Develop confidential and secure uses of the
    internet and cell phones to contact individuals with their test
    results and other disease notification and prevention messages. This
    is particularly important for transmissible infectious diseases,
    such as HIV and other sexually transmitted infections (STIs). The
    goal is to improve our ability to notify infected persons in a
    timely manner so that potential transmissions may be curtailed.

-   Partner Notification -- Develop confidential and secure uses of the
    internet and cell phones for partner notification services. Also,
    include the ability to track the number of partners identified,
    number of partners notified and number of partners tested. The goal
    is to increase the capacity of local health departments and health
    care providers to locate and test partners of persons with HIV and
    other STIs.

-   Geographic Information Systems (GIS) for Public Health -- Develop a
    user-friendly application for public health departments to use GIS
    to target populations for prevention activities. GIS is a powerful
    tool for disease prevention, however, most health departments do not
    have the technical expertise to analyze spatial data. The proposed
    application would circumvent the need to do spatial analysis in
    order to target geographically-clustered high-risk populations. The
    goal is to develop GIS technology that will improve the ability of
    health departments to implement prevention activities.

-   Partnership for Health -- (for the Diffusion of Effective Behavioral
    Interventions (DEBI) program): Develop software design to give
    automated reminders to clinicians to provide prevention counseling
    and preventive care upon opening a patient\'s medical record during
    the clinic visit. This application should also track when counseling
    is given and the patient-reported behavior change. It should be
    compatible with widely-used electronic medical record systems. The
    goal is to improve prevention counseling and preventive care in
    medical care settings.

B. ***[Novel Devices/Technology for Rapid Point-of-Care HIV
Testing]{.underline}***

Despite intensive prevention efforts, an estimated 56,300 new HIV
infections occurred in the United States in 2006. In addition
approximately 25% of the estimated 1.1 million people living with HIV in
the US are unaware of their diagnosis. Innovative approaches and
technology are urgently needed to improve our prevention efforts.

Rapid HIV antibody diagnostic tests have been a major public health
advance because they provide immediate results and can be easily
performed in high-prevalence non-clinical settings. Unfortunately a
limitation of rapid testing is that the result requires confirmatory
testing in a central lab. CDC and the Association of Public Health
Laboratories is updating current testing algorithms with a potential
inclusion of HIV nucleic acid testing as a confirmatory test but
currently rapid tests that detect HIV nucleic acid are not available.

An equally important limitation to HIV prevention efforts has been the
difficulty in identifying individuals during acute HIV infection (AHI).
AHI is defined as the time between HIV acquisition and antibody
seroconversion. Because standard HIV tests (including rapid tests) can
only detect antibodies, a "window period" exists in which a person will
test negative for HIV antibodies despite the presence of infection.
Because individuals with AHI are highly infectious, have *de facto*
recently engaged in high-risk behaviors, and are often unaware of their
HIV status, they may contribute substantially to the spread of HIV.
Studies from Uganda, Canada, and London have suggested that a
disproportionate number (approximately 50%) of new HIV infections are
acquired by onward transmission from an individual with AHI.
Fortunately, most HIV-infected persons take measures to reduce their
risk of transmitting HIV to others after they learn of their infection.
Therefore, identifying persons with AHI is an especially important
opportunity for HIV prevention and is a major justification to develop
improved technologies to screen for AHI in high-risk/high-incidence
venues. AHI can be detected with current diagnostic tests but requires
testing for HIV nucleic acids in a specialized laboratory and may be
difficult to perform in a timely manner.

Rapid HIV tests play an important role in HIV prevention by expanding
access to testing, overcoming barriers to early testing, and improving
linkage to care of infected persons. A rapid test to detect HIV nucleic
acid would enhance HIV prevention efforts by allowing both the rapid
confirmation of HIV infection in general and the rapid diagnosis of AHI
in particular. Emerging technology indicates that it is feasible to
develop a rapid, point-of-care test for AHI and this area of research
would be attractive for small businesses because it has the potential to
eventually become a commercial product.

**Suggested Projects:** Develop rapid (point-of-care) tests for HIV
nucleic acid (RNA and/or DNA) HIV antigen (p24) or combination
antigen/antibody tests that could be used to confirm other point of care
tests, and detect acute HIV infection in clinical and non-clinical
settings. Additionally this technology could be used to aid early infant
HIV diagnosis in Prevention of Mother-to-Child Transmission programs and
to rapidly evaluate treatment response to antiretrovirals in HIV
treatment programs.

Related projects which could take advantage of the same technology:

-   Develop an inexpensive (compared to gene sequencing), simple
    (point-of-care or requiring only a basic lab) test for key HIV
    resistance mutations (e.g. K103N, M184V, K65R) which could enhance
    HIV care in resource limited settings.

-   Develop an inexpensive and simple (point-of-care or requiring only a
    basic lab) assay for semi-quantitative detection of antiretroviral
    drug concentrations in saliva, fingerstick blood spot, or urine.
    This tool could be used as a tool to rapidly evaluate antiretroviral
    adherence. This technology could be applied to other drugs (non-HIV
    drugs) as well.

This SBIR proposal offers an opportunity for collaboration among several
divisions within CDC. Coordinated efforts with other Divisions within
NCHHSTP that focus on diagnosis of pathogens often associated with HIV
infection (STDs and Hepatitis) are logical collaborations that could
lead to more integrated testing of pathogens that are often found in the
same populations. CDC's Global AIDS Program and the Coordinating Office
for Global Health would be particularly interested in how these
technologies could be applied in resource-limited settings to improve
global health. The Division of Reproductive Health, National Center for
Chronic Disease Prevention and Health Promotion would also be interested
in how these technologies could improve HIV diagnosis and prevention in
pregnant women. Finally this technology could be applied to help develop
rapid tests for other infectious disease pathogens (e.g. Malaria,
pandemic Influenza) which would appeal to divisions and centers
throughout CDC.

[]{#__RefHeading___Toc219687206 .anchor}Division of STD Prevention

Research Areas of Interest

A. ***["Talking Books": Reproductive and sexual health comprehension
assistance for US migrant populations]{.underline}***

Migrant populations in the United States are frequently drawn from
marginally-educated persons who are not native English speakers. Health
literacy and knowledge of health care systems are frequent impediments
to health care, including for sexually transmitted disease, pregnancy,
and other reproductive health issues.

**Phase I: Developing audiovisual materials: "talking books".** Talking
books are the generic term for books in which visual illustrations of a
process are accompanied by text at the appropriate literacy level, but
also by audio recording of that same text. For the current topic, the
applicant should propose talking books that describe any or all of (a)
common sexually transmitted diseases, including transmission routes and
prevention, (b) what to expect from a health care visit including
reproductive and sexual health needs. The book may be designed for
patient use or to be used by lay health advisors drawn from migrant
populations. Ideally, the books should have audio recordings in plain
English and in common languages for migrant populations in the US. A
completed and fully functional book that is comprehensible to designated
target populations will constitute proof of concept.

**Phase II: Evaluation.** Applicant will propose settings for evaluation
of the talking book or books from Phase I, with settings and
distribution based on health needs and book content and design. Program
selection will be based on access to the target population. The primary
goals of evaluation are to (a) test feasibility of use, (b) target group
acceptability and satisfaction, and (c) measures of efficacy, for
example, resultant health care visits and treatment. Sustainability with
respect to ensuring the right amount of material remains with the target
populations (patients or health advisors) will also be a consideration.

B. ***[Innovative Communication System for Chlamydial Screening and
Follow-up]{.underline}***

Chlamydial infection is frequently diagnosed outside public clinic
settings and among 15 -- 24 year olds: yearly screening is recommended
for sexually active women \< 26 years old. Infection in this population
may lead to reduced fertility, but adolescent and young adult
familiarity with novel communication technology suggests innovative
approaches to prompting screening and follow-up may increase screening.

**Phase I: Developing and operationalizing an algorithm for reminders
and follow-up.**

Applicants are invited to devise innovative technology-based algorithms
for promoting chlamydial screening and subsequent follow-up (test
results, treatment and partner management options) per recommendations
for use in health care systems with access to 15 -- 25 year old sexually
active women. Delivery systems for screening reminders and subsequent
follow-up should be responsive to target population communication
preferences and device use: multiple means of accessing target group
members with reminders and follow-up are expected. To develop specific
approaches from the point of view of content and message delivery
technology, applicants are expected to use a consumer-centered approach.
CDC will provide available data on audience preferences and tested
messages to inform this process, though applicants may also use their
own (or other) consumer research. An internally-consistent communication
algorithm with positive audience responses to content will constitute
proof of concept for Phase I.

**Phase II: Evaluation.** Applicant will propose program settings for
evaluation of the Phase I algorithm, with program selection based on
access to the target population. Public clinic settings are suitable, as
are managed care organizations with clients in the target population, as
well as colleges and universities. The primary goals of evaluation are
to (a) ensure feasibility, acceptability and efficacy of the delivery
methods and content, and (b) to extend and sustain program reach and
impact. Specifically, the evaluation should assess whether there is an
increase in chlamydial screening, case detection, treatment and
preventive treatment (for partners) among the target population, as well
as confirm preferred methods of screening and test result delivery.
Evaluation should also assess whether particular delivery methods affect
time to diagnosis, treatment, and other follow-up.

For programmatic information, contact:

Ms. Barbara Stewart

Centers for Disease Control and Prevention

Coordinating Center for Infectious Diseases

Strategic Science and Program Unit

Extramural Program

1600 Clifton Road.

Atlanta, Georgia 30333

\(404\) 498-2770

Email: <bstewart@cdc.gov>

For grants specific information, contact:

Ms. Roslyn Curington

Centers for Disease Control and Prevention

Procurement and Grants Office

1600 Clifton Road

Mail Stop E-15

Atlanta, Georgia 30333

\(404\) 639-8321

[]{#__RefHeading___Toc219687207 .anchor}Coordinating Office for
Terrorism Preparedness and Emergency Response (COTPER)

The Coordinating Office for Terrorism Preparedness and Emergency
Response (COTPER) <http://emergency.cdc.gov/cotper/> has primary
oversight and responsibility for programs that comprise the Centers for
Disease Control and Prevention\'s (CDC) terrorism preparedness and
emergency response portfolio. Through an all-hazards approach to
preparedness that focuses on threats from natural, biological, chemical,
nuclear, and radiological events, COTPER helps the nation prepare for
and respond to urgent threats to the public\'s health. COTPER's mission
is to "safeguard health and save lives by providing a flexible and
robust platform for public health emergency response (proposed)." To
carry out its mission, COTPER (1) fosters collaborations, partnerships,
integration, and resource leveraging to increase CDC's health impact and
achieve population health goals; (2) provides strategic direction to
support CDC's terrorism preparedness and emergency response efforts; (3)
manages CDC-wide preparedness and emergency response programs; (4)
maintains concerted emergency response operations---including the
Strategic National Stockpile and the Director's Emergency Operations
Center; and (5) communicates terrorism preparedness and emergency
response activities to internal and external stakeholders.

RESEARCH TOPICS:

COTPER interest in SBIR research is focused on the following research
topic(s). Other research topics that are within the mission of COTPER
are of interest:

A. ***[Computer-Based Models For Evaluating Strategies and Outcomes in
Pandemic Preparedness]{.underline}***

As part of the National Strategy for Pandemic Influenza Implementation
Plan, the Federal Government was tasked to "review and approve state
pandemic influenza plans to supplement and support DHS State Homeland
Security Strategies to ensure that Federal homeland security grants and
other forms of assistance are applied to a common set of priorities in
conformance with the National Preparedness Goal within 12 months". A
priority area of this review was the topic of community containment and
mitigation, which is the use of measures other than vaccination and drug
treatment that might be useful during an influenza pandemic to reduce
its harm. In February 2007, the Centers for Disease Control and
Prevention released interim planning guidance on the use of
non-pharmaceutical interventions to mitigate an influenza pandemic
(Community Strategy for Community Mitigation,
[www.pandemicflu.gov](http://www.pandemicflu.gov/)); however, reviews of
state pandemic influenza operational plans and feedback from state
planners indicate that community mitigation is still an area where
additional guidance and concrete methodology is needed. There is a need
for state and local planners to better identify potential impacts and
implications in each of the CDC defined pandemic severity index levels
for mitigating disease spread, sustaining government and community
infrastructure, and lessening the pandemic's impact on the economy and
the functioning of society (schools, business, transportation, health,
and other community sectors) if the federal government's pandemic
interventions are implemented at the state and community level. A
computerized modeling product using decision-tree algorithms is desired
to help state and local planners examine possible outcomes related to
the application of community containment interventions against state and
local pandemic influenza plans. The model should be readily usable by
staff in Federal, Tribal, State, Territorial, and Local health
departments or by disaster planners and should be developed so that it
can be made available at a low cost.

B. ***[Development of an Improved Reusable Insulated \[Cold-Chain\]
Shipping Container (ISC)]{.underline}***

There is a need for cost-effective methodologies to ship vaccines and
other drugs or biologicals while keeping the cold-chain intact. Research
is needed to develop the technology for a reusable insulated cold-chain
shipping container with specifications that would allow for various
deployment conditions of assets in the Strategic National Stockpile.

Designs are needed for small, medium, and large Insulated Shipping
Containers (ISC) to meet multi-performance ranges preferably within one
ISC configuration for refrigerated and frozen specifications (not more
than two separate configurations are desired). The temperature ranges
for the new ISC design are: 1) Refrigerated specifications: 2° to 8° C;
2) Frozen specifications: -30° to -15° C and -30° to 8° C. Designs must
meet or exceed all ISTA 7D temperature and drop tests on all 6 sides of
ISC; ISC's must be ISTA certified and stamped. Designers must be capable
of providing Qualification, Validation Performance testing in a licensed
ISTA Lab with an ISO 9000/9001 certification for the design. In
addition, the ISC must have state-of-the-art mold resistant and
water/moisture retardant coating on all sides (inner/outer surface);
Must contain disposable moisture absorbent padding material for the
inner bottom of the ISC; Must utilize the same ISC machine tooling for
the corresponding sizes between the 2°C to 8°C ISC and the -30°C to
-15°C / -30C°C to 8°C. All ISC's must have a Universal Pack-out
Configuration with a desirable payload capacity for small: 10.2"x 5.1"x
4.5" (LxWxH); medium: 15" x 9.9" x 6.4"; large: 14.8" x 14.8" x 11". The
ISC's should be deliverable as constructed and ready for long term
storage and or immediate use. Complete packout of ISC's must take no
longer than 30 seconds PCM (phase change materials) must enact at
temperatures -22°C or warmer; No liquid nitrogen or dry ice PCM; No
special considerations for safe disposal; ISC components and materials
must be innocuous, non-toxic, and remain safe for use for minimum of 15
to 20 years; ISC's are to be 100% passive; No battery AC/DC powered
components, No electronic circuitry permitted; the design should be such
that it is functional for a minimum of 15 years under performance
specifications and conditions/stipulations. The technology should be
readily usable by staff in Federal, State and Local health departments
or by disaster planners that require management or re-distribution of
stockpile materials. Optimally, the systems developed should have low
maintenance costs; estimated costs for development should be documented.
In addition, evaluation and validation of the shipping systems are
required. Validation specifications and maximum tare weight requirements
will be provided upon request.

C. ***[Training in Public Health Ethics for Public Health
Responders]{.underline}***

There is a need for specific training for public health responders about
the complex ethical and social values that are involved in the planning,
response, and follow-up phases of public health emergencies. Research is
needed to develop training modules for public health professionals and
practitioners on ethical principles and to explore key ethical issues
related to public health emergency preparedness and response. Where
appropriate, the training should provide guidance to reconcile potential
ethics issues. When developing the training, the grantee should consider
all available public health ethics frameworks. The specific frameworks
utilized should be articulated in the proposed project. The training
should be readily usable by staff in Federal, Tribal, State,
Territorial, and Local health departments or by disaster planners and
should be developed so that it can be made available at a low cost. In
addition, evaluation of the effectiveness of the training should be
incorporated into the training modules produced (e.g., exam questions).
A computer or web-based training platform is desired but not essential.

D. ***[State, Local, Community and Faith Based Tools and Resources for
Protecting Vulnerable Populations from Excess Health Burden During
All-Hazards Events]{.underline}***

The unanticipated consequences of Hurricane Katrina uncovered a host of
realities that need to be addressed to systematically prevent similar
circumstances in the event of future hurricanes or other disasters of
catastrophic magnitude. Although substantial progress has been made to
design communication materials to reach vulnerable populations, the
specific preparedness, response and recovery needs of vulnerable
populations and the factors that contribute to vulnerability are still
inadequately understood among first responders. Concerned public health
professionals and first responders have engaged in efforts to develop
guidelines and resources for protecting vulnerable populations during
disasters. However, there continues to be a need for a useful, validated
tool that can be used across the broad spectrum of preparedness
stakeholders. Input from consumers and stakeholders indicate that
research is needed to develop broad-spectrum, field-tested tools and
resources to address population specific and functional needs of
vulnerable populations in response to all-types of public health
hazards. This technology should be readily accessible to and usable by
responders and staff from Federal agencies, State and Local health
departments, National Volunteer Organizations Active in Disasters
(VOAD), local community and faith-based organizations, and other
disaster planners. Optimally, the tools and resources developed should
have low maintenance costs and that can be documented. In addition,
evaluation and validation of the tools and resources is required. The
following is of particular interest:

-   Development of tools and resources to systematically identify and
    plan for the All-hazards Emergency and Response needs of vulnerable
    populations. Tools should have the ability to target specific
    vulnerable population groups and functional needs such as the need
    for sheltering, food and water, medication, or transport and should
    go beyond currently available resources for vulnerable populations,
    be easily implemented, and adaptable to varying community and
    vulnerable population needs.

E. ***[Pre-Hospital Transport Vehicle for the Acutely
Injured]{.underline}***

The management of injuries and trauma related morbidity during a public
health emergency is a significant aspect in preparedness planning. In
many cases those at greatest risk from injuries are the young or those
with limited economic and social support systems. In addition to the
scarcity of resources, such as may occur in rural settings, several
factors may contribute to the difficulty in managing injuries during an
event including:

-   Remote locations with poor communication

-   Traffic congestion

-   Poor road infrastructure and access

-   Lack of trained personnel

-   Lack of appropriate equipment and supplies

-   Deficiencies in ability to deliver timely definitive care

In these settings, effective public health interventions that are both
economically and technically feasible will become increasingly important
in mitigating the severe public health impacts of injuries, especially
during an emergency event.

There is a need to develop pre-hospital transport capability
(ambulances) specifically designed for application in such settings. The
WHO, with support from CDC, led the development of trauma and emergency
care systems that are applicable for conditions in an emergency event.
WHO published Pre-hospital Trauma Care Systems and Guidelines for
Essential Trauma Care to support the development and use of these
systems internationally. A critical component in the care of the acutely
ill or injured patient is timely transport to definitive care facilities
under the challenging circumstances often encountered during various
emergency events.

For use in these situations, the vehicle design process needs to take
into account the following desired characteristics:

-   Low manufacturing cost

-   Low maintenance and fuel costs

-   Capable of moving on paved and non-paved surfaces

-   Capable of navigating narrow passages

-   Warning devices and capability for poor weather use

-   Seats with seatbelts for a driver, care provider

-   Capable of securing a stretcher or having a padded bench with
    seatbelts for a patient to be able to lie flat

-   Capable of securely carrying necessary equipment and supplies for
    the proposed level of care to be provided (e.g. as outlined in
    Pre-hospital Trauma Care Systems)

F. ***[Technologies for Rapid and Efficient Communication in Emergency
Response]{.underline}***

Effective communication is crucial for emergency response before,
during, and after a public health emergency event. Factors in emergency
response communication include effective strategies to facilitate rapid
information exchange, clear communication messaging to reach target
audiences, established channels of communication, and others. Research
is needed to develop or enhance existing communication technologies for
use in emergency response. Design factors should improve upon existing
technologies, such as improved ease of use under all hazard conditions,
longer signal range, extended period of operability, lower cost to
operate and/or to maintain, etc. Technology should be usable by
responders and staff from Federal agencies, State and Local health
departments, National Volunteer Organizations Active in Disasters
(VOAD), local community and faith-based organizations, and other
disaster planners.

Contact for additional information on research topics:

Mildred Williams-Johnson, PhD, DABT

Coordinating Office for Terrorism Preparedness

and Emergency Response

Centers for Disease Control and Prevention

404-639-7719; Fax: 404-639-7977

E-mail: <MWilliams-Johnson@cdc.gov>

For grants specific, administrative information, contact:

Nealean Austin

Procurement and Grants Office

Centers for Disease Control and Prevention

770-488-2771; Fax: 770-488-2777

E-mail: <NaAustin@cdc.gov>

[]{#__RefHeading___Toc219687208 .anchor}FOOD AND DRUG ADMINISTRATION
(FDA)

FDA will accept SBIR grant applications on the April 5, August 5, and
December 5, 2009 submission dates.

The FDA is responsible for protecting the public health by assuring the
safety, efficacy, and security of human and veterinary drugs, biological
products, medical devices, our nation's food supply, cosmetics, and
products that emit radiation. The FDA is also responsible for advancing
the public health by helping to speed innovations that make medicines
and foods more effective, safer, and more affordable; and helping the
public get accurate, science-based information they need to use
medicines and foods to improve their health.

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___Toc219687209 .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___Toc219687210 .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, post marketing
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, post marketing drug safety, evaluation of effectiveness of
regulatory actions, patterns of drug use, including off-label, signal
detection methodologies (e.g., data mining 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 practitioners 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___Toc219687211 .anchor}Center for Food Safety and
Applied Nutrition (CFSAN)

The FDA is responsible for the safety of the vast range of food
Americans eat; about 80 percent of all food sold in the United States.
This includes everything except for the meat, poultry, and processed egg
products that are regulated by the USDA. Consequently CFSAN seeks
research designed to complement and accelerate efforts aimed at the
detection, prevention, and control of contamination that may be
responsible for illness or injury conveyed by foods, colors, and
cosmetics. CFSAN conducts research, and develops regulations, guidance
and standards related to the composition, quality, nutrition, and safety
of food, food additives, colors, and cosmetics. The Center 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 and food additives.

CFSAN maintains an active research program that is focused on the
following priorities; ensuring the safety of food, dietary supplements
and cosmetics; improving nutrition; and promoting the security and
integrity of the food supply. The Center's research activities are
intended to; support the FDA's regulatory activities; reduce the
incidence of foodborne illness by improving our ability to detect and
quantify foodborne pathogens, toxins, and chemicals that could
jeopardize the safety and security of the food supply; find new and
improved ways to control these agents; and safely produce, process, and
handle food and food products. FDA is committed to reducing the
incidence of foodborne illness to the greatest extent feasible while at
the same time protecting the nation\'s food supply. Mission-critical
knowledge gaps are addressed through translation research focused on the
risks associated with FDA regulated products throughout their life
cycles, from production to consumption. Ideally extramural research is
sought that complements the Center's intramural research efforts, and
which will enhance the Agency's and the Nation's ability to reduce the
incidence of foodborne illness and protect the integrity of the nation's
food supply. FDA's mission-critical needs require that the research not
simply end with the generation of new knowledge and technologies, but
extend to the validation of new approaches by using realistic conditions
that accurately reflect the diversity of the food industry and offer
potential solutions that can be accept by appropriate sectors of the
food industry.

[]{#__RefHeading___Toc219687212 .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 effectiveness standards and good
manufacturing practices regulations, operates post market 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 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.

Research and development opportunities within the FDA that lend
themselves to performance by small businesses include, but are not
limited to, the following:

A. Examine the setup, documentation and optimization of our Sun Grid
Engine (SGE). The architecture of this networking application is
particularly suited to managing surge capacity in high performance
computing. The modeling of many physiologic functions and bioinformatic
analyses can take months or even years to run on a standard desktop
computer. The SGE takes the overall problem and distributes it to a
cloud of computers on a network so that no user knows, or cares, if a
computation is performing in the background on their machine. As FDA
rolls out laptops with multi-core CPU\'s and which are equipped with
prodigious amounts memory this experiment in \"cloud computing\" could
become a reality on the Whiteoak Campus. The scope of work would be to
develop, document, and provide training systems for developers, network
architects, and users on working methodologies for the integration of
cloud computing with the existing FISMA compliant conventional
networking.

B. Develop a high-speed, low light spectral CMOS linear imaging system
to measure complete spectra of multiple variables from living tissue.
Complete spectra of fluorescence signals (including auto-fluorescence
and FRET) could be measured along a line at high speeds (10 kHz) with a
rectangular CMOS grid (e.g. 10 x 1,000 pixels -\> 10 sites 1000
wavelengths).

C. Develop bioassays/biosensors to identify injurious levels of nerve
stimulation utilizing bioluminescence and neurotransmitter detection
technologies. Research capabilities needed include voltage clamp,
current clamp and extracellular techniques in peripheral nerves and
brain slices to explore stimulation protocols that release neuroactive
substances released in injury and inflammation which are not normally
evoked under normal physiological conditions.

D. Design, build, and validate a phantom that is traceable to a national
metrology institute (NMI) such as NIST (or any other NMI) to improve the
accuracy and clinical utility of bone mineral density measurements made
using dual energy X-ray absorptiometry (DXA). The calibration phantom
should be constructed using biosurrogate materials with known/tabulated
data for body tissue and tissue substitutes.

[]{#__RefHeading___Toc219687213 .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.

Research and development opportunities within the Center for Veterinary
Medicine that lend themselves to performance by small businesses
include, but are not limited to, the following areas of interest:

A. Development, for the specific purpose of obtaining approval or
conditional approval, of products for the treatment, control or
prevention of diseases or conditions occurring in minor species or small
numbers of major species.

B. Development and validation of high throughput/screening quantitative
and qualitative analytical methods for analyzing drugs, additives, and
contaminants in animal tissues and feeds.

C. Development of methods to determine absorption, distribution,
metabolism, and excretion of drugs, feed additives and contaminants
(microbial and chemical) in food animals, including minor species.

D. Development of new biomarkers and models for determining the safety
and effectiveness of veterinary drugs and food additives in domestic
animals, including minor species.

E. Development of methods to determine the effects of drugs, food
additives, and contaminants (microbial and chemical) on immunological
and physiological functions of domestic animals, including minor
species.

[]{#__RefHeading___Toc219687214 .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 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.

B. 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.

C. Development of vaccines for the prevention of rare diseases to be
used in fewer than 200,000 persons annually in the United States.

[]{#__RefHeading___Toc219687215 .anchor}Other Research Topic(s) Within
the Mission of FDA

For additional information on research topics and administrative and
business information, contact:

Ms. Michelle Hawley

Chief, Grants Management Officer

301-827-1991, Fax: 301-827-7101

Email: <michelle.hawley@fda.hhs.gov>

or

Ms. Gladys Melendez-Bohler

Grants Management Specialist/Grants Management Officer

Grants and Assistance Agreements Team

301-827-7168, Fax: 301-827-7101

Email: <Gladys.Melendez-Bohler@fda.hhs.gov>

Food and Drug Administration

Division of Acquisition Support and Grants

5600 Fishers Lane - HFA 500

Rockville, MD 20857

[]{#__RefHeading___Toc219687216 .anchor}Administration for Children and
Families

The Administration for Children and Families (ACF), within the
Department of Health and Human Services (HHS) is responsible for federal
programs that promote the economic and social well-being of families,
children, individuals, and communities. ACF partners with State and
local governments, for-profit and non-profit organizations, faith- and
community-based organizations, American Indian Tribes and Native
American communities to design, administer and promote programs in areas
such as child welfare, childcare, Head Start, healthy marriage,
Temporary Assistance for Needy Families (TANF), and responsible
fatherhood.

The Office of Planning, Research and Evaluation (OPRE) facilitates ACF's
SBIR investments. The Office provides guidance, analysis, technical
assistance, and oversight to ACF programs on strategic planning aimed at
measurable results; research and evaluation methodologies; demonstration
testing and model development; statistical, policy and program analysis;
synthesis and dissemination of research and demonstration findings.

The focus of the research topics for SBIR should reflect the research
and programmatic interests of ACF. Particular areas of interest for ACF
include but are not limited to:

Adoption and Foster Care

Child Abuse & Neglect

Child Care

Child Support

Developmental Disabilities

Early Head Start

Energy Assistance

Family/Domestic Violence

Fatherhood and Healthy Marriage

Head Start

Native American and Tribal Programs

Refugee Resettlement

Human Trafficking

Temporary Assistance for Needy Families

Youth Development

For additional information on ACF programs and research, please visit
the ACF website at [http://www.acf.hhs.gov](http://www.acf.hhs.gov/) and
the Office of Planning, Research and Evaluation's website at
<http://www.acf.hhs.gov/programs/opre/index.html>.

For additional information on research topics, contact:

Anne F. Bergan

Social Science Research Analyst

Office of Planning, Research and Evaluation

Administration for Children and Families

370 L\'Enfant Promenade, SW

Washington, DC 20447

Phone: 202-260-8515

Fax: 202-205-3598

E-mail: <abergan@acf.hhs.gov>

For administrative and business management questions, contact:

Edeltraud Fernandez

Budget Officer/Staff Assistant

Office of Planning, Research and Evaluation

Administration for Children and Families

370 L\'Enfant Promenade, SW

Washington, DC 20447

Phone: 202-401-2346

Fax: 202-205-3598

E-mail: <efernandez@acf.hhs.gov>