NIH SBIRSTTR Program FY2001

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National Institutes of Health SMALL BUSINESS
FUNDINGOPPORTUNIHTIES
Biotech Entrepreneur to Entrepreneur Alternative
Funding Fair
February 28, 2003 Menlo Park, CA
Jo Anne Goodnight NIH SBIR/STTR Program
Coordinator Phone [phone] Fax 301-
480- 0146 Email jg128w_at_nih.gov
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SBIR/STTR PROGRAM GENERAL FEATURES
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SBIR/STTR 3-Phase Program

• PHASE I
• Feasibility Study
• 100K and 6-month (SBIR)
• or 12-month (STTR) Award

• PHASE II
• Full Research/RD
• 750K and 2-year Award
• (SBIR/STTR)

• PHASE III
• Commercialization Stage
• Use of non-SBIR/STTR Funds

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SBIR PROGRAM ELIGIBILITY CHECKPOINTS
Organized for- profit U.S. business At
least 51 U.S.- owned and independently
operated Small Business located in the U.S.
500 or fewer employees P.I.s primary
employment with small business during
project
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Important Facts to Remember

• Eligibility is determined at time of award
• No appendices allowed in Phase I
• The PI is not required to have a Ph.D.
• The PI is required to have expertise to oversee
  
• project scientifically and technically
• Applications may be submitted to different
• agencies for similar work
• Awards may not be accepted from different
• agencies for duplicative projects

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SBIR/STTR Whats New?

• SBIR reauthorized through FY 2008
• STTR reauthorized through FY 2009
• Set aside doubles to 0.30 in FY2004
• Phase II awards increase to 750,000
• Commercialization Plans Phase II applications
• Public Database Basic Award Information
• (Tech-Net-- http//technet.sba.gov )
• Government Database Program Evaluation
• (Phase II awardees -- e.g., new product sale
  
• revenues other investment funding sources)

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SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

• Research Partner
• SBIR Permits partnering
• Outsource 33 Phase I and 50
  Phase II RD
• STTR Requires research institution
• partner (e.g., university)
• 40 small business concerns
  (for-profit) and
• 30 U.S. research institution
  (non-profit)

AWARD ALWAYS MADE TO SMALL BUSINESS
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SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

• Principal Investigator
• SBIR Primary (gt50) employment must be with
  small business concern
• STTR Primary employment not stipulated
• PI can be from research institution
  and/or
• from small business concern

DISCUSS WITH AGENCIES
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NIH SBIR/STTR PROGRAM FEATURES and NUANCES
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National Institutes of Health
Our Mission Improve human health through
biomedical and behavioral research, research
training and communications.
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• SBCs can use SBIR/STTR
• help NIH meet its mission
• Conduct innovative R/RD that results in product,
  process, or service that will...
• Improve patient health
• (prevention, detection, diagnosis and
  treatment
• of disease or disability)
• Speed process of discovery
• Reduce cost of medical care/cost of research
• Improve research tools

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National Institutes of Health
http//www.nih.gov/icd/
Each IC receives separate SBIR/STTR allocation
National Institute on Alcohol Abuse and Alcoholism
National Institute of Arthritis
and Musculoskeletal and Skin Diseases
National Cancer Institute
National Institute on Aging
National Institute of Child Health and
Human Development
National Institute of Allergy and Infectious
Diseases
National Institute of Dental and Craniofacial Rese
arch
National Institute of Diabetes and Digestive
and Kidney Diseases
National Institute on Drug Abuse
National Institute of Environmental Health
Sciences
National Institute on Deafness and
Other Communication Disorders
National Eye Institute
National Human Genome Research Institute
National Heart, Lung, and Blood Institute
National Institute of Mental Health
National Institute of Neurological Disorders
and Stroke
National Institute of General Medical Sciences
National Institute of Nursing Research
National Institute of Biomedical Imaging and
Bioengineering
National Center for Complementary and
Alternative Medicine
National Library of Medicine
Fogarty International Center
National Center for Research Resources
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SBIR/STTR Participating Agencies
TOTAL 1.6 B FY 2003

• DOD SBIR/STTR
• NASA SBIR/STTR
• DOE SBIR/STTR
• NSF SBIR/STTR
• USDA SBIR
• DOC SBIR
• ED SBIR
• EPA SBIR
• DOT SBIR

(estimate) NIH 500 M SBIR 30 M STTR
530 M Total CDC 9.0 M SBIR FDA
0.8 M SBIR AHRQ 2.1 M SBIR

• HHS SBIR/STTR

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DOES MY TECHNOLOGY FIT IN NIH?
See Mission Statement!
Solution to Real Problem. that affects Real
People!
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NIH SBIR/STTR PROGRAM OPERATIONAL NUANCES
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APPLICATION TO AWARD TIMELINE
2-tiered review process
SBIR/STTR Scientific/Technical Adv
Council Est.Award Receipt
Dates Peer Review Board Review
Date Apr 1 June/July Sept/Oct
Nov Aug 1 Oct/Nov Jan/Feb
Mar Dec 1 Feb/March May/June
July
90-Day pre-award costs are allowable At your
own risk..
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NIH SBIR/STTR FAST-TRACK Bridging the Funding Gap
Phase I Completed Submit satisfactory Phase I
Final Report
Discuss Fast-Track option with Program Director
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APPLICATION, REVIEW, and AWARD
Submits SBIR/STTR Grant Application to NIH
2-3 months after submission
2-3 months after review
IC Staff Prepare funding Plan for IC Director
Grantee Conducts Research
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NIH SBIR/STTR APPLICATION ASSIGNMENTS

• One receipt point CSR
• Receipt and Referral Office makes
• assignments based on science

• Research areas may overlap ICs
• When appropriate
• request multiple IC assignments

• Dual assignments funding issue
• NOT a review issue

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Applications Submitted to NIHCenter for
Scientific Review
Cover Letter A Valuable Tool

• Suggest potential awarding component(s)
• Discuss areas of expertise appropriate for the
  applications review
• Indicate individual(s) or organization(s) in
  conflict

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RESEARCH AREAS SUPPORTED
Our ideas .

• SBIR/STTR Grant Solicitation
• SBIR Contract Solicitation
• NIH Guide for Grants and Contracts
• Weekly announcements of new initiatives
• http//grants.nih.gov/grants/guide/index
  .html

Closed November 8, 2002
Your ideas...

• Investigator-initiated RD

Take-home Message 1
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Never, ever, think outside the box.

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SBIR/STTR Omnibus Solicitationhttp//grants.nih.g
ov/grants/funding/sbirsttr1/index.pdf

• Mission statement
• General areas of research
• Research Topics
• Other Research Within the Mission of the IC
• (a.k.a. Your Ideas)

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Examples of Cross-Cutting Areas of Interest

• Biodefense
• Biosensors
• Nanotechnologies
• Bioinformatics
• Proteomics/Genomics
• Biosilicon devices
• Biocompatible materials
• Acousto-optics and opto-electronics
• Imaging technologies
• Genetically engineered proteins

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Beyond the Omnibus SBIR/STTR Grant Solicitation
NIH Research Initiatives

• NIH Guide for Grants and Contracts
• FY2003 Initiatives for Presidents Budget
• Transitioning SBIR/STTR From Phase II to Phase III

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NIH Guide Program Announcements(PAs)

• Specific area of interest to one or more ICs
• Usually reviewed by Center for Scientific
• Review
• Receipt Dates may vary from standard

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NIH GuideRequest For Applications (RFAs)

• Targeted area of research for single IC
• Reviewed by that IC
• Usually a single receipt date
• Set-aside (within a set-aside!) of funds.

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Research Areas of ICsNIH Guide
http//grants.nih.gov/grants/guide/index.html
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SPECIFIC AREAS OF INTEREST

• SMALL BUSINESS BIODEFENSE PROGRAM
• http//grants.nih.gov/grants/guide/pa-files/PAS-02
  -149.html
• WHO NIAID
• MOLECULAR TARGETS FOR CANCER DRUG DISCOVERY
• http//grants.nih.gov/grants/guide/pa-files/PA-03-
  021.html
• WHO NCI
• APPLICATIONS OF INNOVATIVE TECHNOLOGIES FOR THE
  MOLECULAR ANALYSIS OF CANCER SBIR/STTR
• http//grants.nih.gov/grants/guide/pa-files/PAR-01
  -107.html
• WHO NCI

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SPECIFIC AREAS OF INTEREST

• NIDDK EXPANDED AWARDS FOR SBIR-AT-NIDDK
• http//grants.nih.gov/grants/guide/pa-files/PA-01-
  093.html
• WHO NIDDK
• IMMUNOTHERAPY FOR ADDICTION TREATMENT      
• http//grants1.nih.gov/grants/guide/rfa-files/RFA-
  DA-03-015.html
• WHO NIDA
• CHEMICAL SCREENS FOR NEW INDUCERS OF FETAL
  HEMOGLOBIN
• http//grants1.nih.gov/grants/guide/pa-files/PA-03
  -049.html
• WHO NIDDK, NHLBI

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SPECIFIC AREAS OF INTEREST

• TELEHEALTH TECHNOLOGIES DEVELOPMENT
• http//grants1.nih.gov/grants/guide/pa-files/PA-03
  -030.html
• WHO NIBIB
• KNOWLEDGE INTEGRATION ACROSS DISTRIBUTED
  HETEROGENEOUS DATA SOURCES
• http//grants.nih.gov/grants/guide/pa-files/PA-03-
  001.html
• WHO NCRR, NIMH. NHLBI, NIBIB
• BIOENGINEERING NANOTECHNOLOGY INITIATIVE
• http//grants.nih.gov/grants/guide/pa-files/PA-02-
  125.html
• WHO Trans-NIH

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SPECIFIC AREAS OF INTEREST

• STRUCTURAL BIOLOGY OF MEMBRANE PROTEINS
• http//grants.nih.gov/grants/guide/pa-files/PA-02-
  108.html
• WHO NIGMS, NCI, NIA, NIAMS, NIDCD, NIEHS, NIMH,
  NINDS
• DEVELOPMENT OF NEW TECHNOLOGIES AND PRODUCTS FOR
  DENTAL CLINICAL INFECTION CONTROL
• http//grants.nih.gov/grants/guide/pa-files/PA-02-
  089.html
• WHO NIDCR
• SYSTEMS AND METHODS FOR SMALL ANIMAL IMAGING
• http//grants.nih.gov/grants/guide/pa-files/PA-03-
  031.html
• WHO NIBIB, NHLBI, NIEHS, NCRR, NIDDK, NINDS

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SPECIFIC AREAS OF INTEREST

• COMPETING CONTINUATION AWARDS OF SBIR PHASE II
  GRANTS FOR PHARMACOLOGIC AGENTS AND DRUGS FOR
  MENTAL DISORDERS
• http//grants2.nih.gov/grants/guide/pa-files/PA-02
  -173.html
• WHO NIMH

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NIH FY 2003 Research Initiatives (Presidents
Budget)

• Biodefense
• - maximize efforts of industry, academia, Federal
  researchers to accelerate development of new and
  safer vaccines, therapeutics, and improved
  diagnostic tests

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NIH FY 2003 Research Initiatives (Presidents
Budget)

• Cancer
• - largest ever prevention study to determine if
  vitamin E and selenium can protect against
  prostate cancer
• - digital vs. standard mammography
• - potential interactions of genetics and
  environmental exposure

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NIH FY 2003 Research Initiatives (Presidents
Budget)

• Diabetes
• - Type 2 diabetes .develop more effective
  methods to identify individuals with impaired
  glucose tolerance
• -Type 1 diabetes research on islet
  transplantation
• - interventions to reduce risk of diabetes and
  obesity

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NIH FY 2003 Research Initiatives (Presidents
Budget)

• Minority Health and Health Disparities
• - Research on drug abuse and addiction in effort
  to reduce impact of HIV/AIDS
• Parkinsons Disease
• - deep brain stimulation for treatment

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REVIEW CRITERIA (Phase I)

• Significance (Real Problem/Real People)
• Approach (Research Design, Feasible)
• Innovation (New or Improved?)
• Investigators (PI and team)
• Environment (Facilities/Resources)
• Protection of Human Subjects
• Animal Welfare
• Budget

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REVIEW CRITERIA (Phase II)

• See Previous Slide
• Demonstrated Feasibility in Phase I
• Product Development Plan
• High Degree of Commercial Potential based on PDP
  
• Protection of Human Subjects
• Animal Welfare
• Budget

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REVIEW CRITERIA (Amended)

• See Previous Slide(s) as appropriate
• Responses to comments from the previous review
• Appropriateness of improvements in the revised
  application

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NATIONAL INSTITUTES OF HEALTHSBIR/STTR FUNDING
RATES for FISCAL YEAR 2002
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499 M SBIR/STTR
335
63
48
81
Success Rate ()
880
44
33
25
27
17
0
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FOR MORE INFORMATION
Visit the NIH Small Business Funding
Opportunities Website

• Solicitations, Forms and Instructions
• Collaborative Opportunities and
• Research Partnerships (CORP)
• SBIR/STTR Award Data and Abstracts
• Policy and Grantsmanship Information
• Invention Reporting Requirements

• Other Small Business Sites of Interest
• Conferences
• Success Stories
• Information For New Grantees
• Financial Questionnaire
• Review Committees

New!
New!
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Key to the NIH Application, Review, and Award
Process
Communication
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NIH Program Staff Pre- Application
Assess the fit Whats New PAs/RFAs Assist in
finding collaborators Review Issues Dos and
Donts Define product and focus application
Application
Review
Award
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NIH Program Staff Post Review

• Discuss outcome of peer review
• What the rating means (numeric vs. )
• Strengths and weaknesses
• Likelihood of funding
• Next steps

If at first you dont succeed.
Revise and resubmit
Application
Review
Award
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NIH Review Staff

• Scientific Review Administrator.
• Point of contact during review process
• Recruitment/Assignment of Reviewers
• Concerns about I/C Assignment or Review

Review
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NIH Grants Management Staff
Pre-Award Steps Post-Award Advice Guidance
Award
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NIH SBIR/STTR Program Coordinator
Guidance and Advice.... Success Stories
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Future Directions at NIH to Assist Companies in
Commercialization

• Competing Continuation Phase II Applications
• Technical Assistance Programs at NIH

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Future Directions at NIH to Assist Companies in
Commercialization

• Competing Continuation Phase II application

http//grants.nih.gov/grants/guide/pa-files/PA-02-
173.html

• Purpose
• - To take existing, promising compounds developed
  under a Phase II through the next step of drug
  discovery and development.
• Additional research support to address clinical
  issues, and other issues relevant to regulatory
  approval
• (e.g., FDA)

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Future Directions at NIH to Assist Companies in
Commercialization

• Competing Continuation Phase II application

Phase I
Phase II
Phase III
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Future Directions at NIH to Assist Companies in
Commercialization

• Competitive Continuation Phase II application

http//grants.nih.gov/grants/guide/pa-files/PA-02-
173.html

• Eligibility
• SBIR Phase II awardee
• Promising pharmacologic agents have already been
  identified and some preclinical pharmacology has
  been conducted.
• Response to an NIH Program Announcement
• (e.g., NIMH)

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Future Directions at NIH to Assist Companies in
Commercialization

• Competitive Continuation Phase II application

http//grants.nih.gov/grants/guide/pa-files/PA-02-
173.html

• Award Amount and Project Period
• Up to 3 years
• 800,000 total costs per year

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Future Directions at NIH to Assist Companies in
Commercialization

• Technical Assistance Programs at NIH
• Pilot CAP Program (NCI)
• Identify menu of items to offer through other
  TAPs

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Pilot Commercialization Assistance Program

• Goal Teach business skills to help mature
  SBIR/STTR-developed technologies (move them
  forward into marketplace)
• Focus
• Business plan development
• Opportunity forum (marriage broker)

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Development of Technical Assistance Menu

• Assistance with
• Developing Product Development Plan
• Developing business plans
• Valuing a technology
• Risk assessment
• Market assessment
• IND filings
• Manufacturing issues

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Im from the Government, and Im here to help
you.
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National Institute of Environmental Health
Sciences
Fogarty International Center
National Institute on Aging
National Institute of Diabetes and Digestive
and Kidney Diseases
National Cancer Institute
National Institute of Child Health and
Human Development
National Eye Institute
National Institute of Biomedical Imaging and
Bioengineering
National Institute on Drug Abuse
National Institute of Dental and Craniofacial Rese
arch
National Human Genome Research Institute
National Institute of Arthritis
and Musculoskeletal and Skin Diseases
National Institute of General Medical Sciences
National Institute of Mental Health
National Institute of Nursing Research
National Center for Research Resources
National Heart, Lung, and Blood Institute
National Institute on Deafness and
Other Communication Disorders
National Institute of Allergy and Infectious
Diseases
National Institute of Neurological Disorders
and Stroke
National Library of Medicine
National Center on Minority Health and Health
Disparities
National Institute on Alcohol Abuse and Alcoholism
New!
National Center for Complementary and
Alternative Medicine
Largest SBIR/STTR set-asides
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National Institutes of Health
http//www.nih.gov/icd/
Office of the Director
National Center on Minority Health and Health
Disparities
Largest SBIR/STTR set-asides

New!
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NIH Program Activities and Areas of Research
NCI-- cancer cause, prevention, detection,
diagnosis, treatment and control
NHLBI-- diseases of heart, blood vessels, lungs,
blood, and transfusion medicine
NIDCR-- understand, treat and prevent infectious
and inherited craniofacial-oral-dental diseases
and disorders
NINDS-- diagnosis, treatment, and prevention of
disorders of the nervous system, neuromuscular
apparatus, and special senses of touch/pain
NIDDK-- diabetes, endocrinology, and metabolic
diseases digestive diseases and nutrition
kidney, urologic and hematologic diseases
NIAID-- understand, treat and prevent infectious,
immunologic, and allergic diseases, bio-defense
research, emerging infectious diseases
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NIH Program Activities and Areas of Research
(cont.)
NIBIB-- basic research relating to the discovery,
design, development, translation and assessment
of new knowledge in biomedical imaging and
bioengineering.
NIGMS-- basic biomedical research not targeted to
diseases or disorders recombinant DNA technology
NICHD-- fertility, pregnancy, growth,
development, and medical rehabilitation
NEI-- blinding eye diseases, visual disorders,
mechanisms of visual function, preservation of
sight, requirements of the blind
NIEHS-- identification, assessment, and mechanism
of action of environmental agents that are
potentially harmful to human health
NIA-- biomedical, social, and behavioral aspects
of aging process prevention of age-related
diseases and disabilities promotion of better
QOL for older Americans
62
NIH Program Activities and Areas of Research
(cont.)
NIAMS-- arthritis/rheumatic diseases, connective
tissue diseases, musculoskeletal and skin
disorders
NIDCD-- normal mechanisms, diseases, and
disorders of hearing, balance, smell, taste,
voice, speech and language
NIMH-- understanding, treating, preventing
behavioral and mental disorders (including HIV
prevention, neuro-AIDS research)
NIDA-- behavioral strategies for treatment
medication training in drug abuse treatment
techniques drug abuse and drug addiction
treatment
NIAAA-- treatment and prevention of alcoholism
and alcohol-related problems
NINR-- understand effects of acute and chronic
illness, improving QOL, approaches to promote
health and prevent disease, improving clinical
environments
63
NIH Program Activities and Areas of Research
(cont.)
NHGRI-- efforts toward achieving the goals of the
Human Genome Project
NCRR-- RD in instrumentation and specialized
technologies for biomedical research RD in
comparative medicine discovery-oriented software
for science education
NCCAM-- complementary and alternative treatment,
diagnostic, and prevention modalities,
disciplines and systems education and public
information patient management botanical
products
NLM-- innovative methods, systems, and services
for managing health knowledge and information
telemedicine
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NIH Program Activities and Areas of Research
(cont.)
NCMHD-- biological and bio-behavioral 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.
65
Jo Anne Goodnight NIH SBIR/STTR Program
Coordinator Phone [phone] Fax
301-480-0146 Email jg128w_at_nih.gov