Training

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Second Annual NIH SBIR/STTR Conference Health
Benefits from Entrepreneurial Innovative Research
July 11-12, 2000 Natcher Conference
Center Bethesda, MD
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SMALL BUSINESS FUNDING OPPORTUNIHTIES
Jo Anne Goodnight SBIR/STTR Program
Coordinator National Institutes of Health 6701
Rockledge Drive Room 6186 - MSC 7910
Bethesda, MD 20892 Phone [phone]
Email jg128w_at_nih.gov
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CONFERENCE GOALS

• We really ARE here to help you
• Understand NIH SBIR/STTR Program and Funding
  Opportunities
• Understand NIH application, review and award
  process better
• More confident about submitting a competitive
  application
• Take advantage of the networking opportunities
• Enjoy yourself!

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Extramural Programs Reserved for Small Business
SMALL BUSINESS INNOVATION RESEARCH (SBIR)
PROGRAM SMALL BUSINESS TECHNOLOGY TRANSFER
(STTR) PROGRAM The best way to predict the
future is to create it.
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Extramural Programs Reserved for Small Business

• SBIR Set-aside Program for Small Business
• Concerns to engage in Federal RD--
• innovative ideas with commercial potential.
• STTR Set-aside Program to facilitate
• cooperative RD between Small Business
• Concerns and U.S. Research Institutions--
• innovative ideas with commercial potential.

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Never, ever, think outside the box.
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WHY SBIR????
Small Business Innovation Development Act of 1982

• Congress designated 4 major goals
• Stimulate technological innovation
• Use small business to meet federal RD needs
• Foster and encourage participation by minority
  and disadvantaged persons in technological
  innovation
• Increase private-sector commercialization
  innovations derived from federal RD

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1992 REAUTHORIZATION of SBIR PROGRAM
PURPOSES OF P.L. 102-564, SIGNED 10/28/92

• Expand and improve SBIR Program
• Emphasize goal of increasing private sector
  commercialization
• Increase small business participation in Federal
  RD
• Improve dissemination of information on SBIR
  Program

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SBIR PROGRAM

• Program re-authorized through FY 2000
• 10 agencies with RD budgets greater than 100
  Million participate
• Amounts to be Set-aside of RD Budget
• FY 1987-92 1.25
• FY 1993-94 1.5
• FY 1995-96 2.0
• FY 1997 and Beyond 2.5

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SBIR/STTR Historical Relationships
1982
1997
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SBIR/STTR Historical Relationships
1982
1998
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SBIR/STTR Historical Relationships
2000
1982
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Research Institution Partnership Opportunities

• Own small firms (assign someone else PI)
• Principal Investigator
• (with official permission from University)
• Senior Personnel on SBIR/STTR
• Consultants on SBIR/STTR
• Subcontract on SBIR/STTR
• University facilities can provide analytical
• and other service support

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SBIR/STTR Participating Agencies
TOTAL 1.2 B FY 2000

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

• HHS SBIR/STTR

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Were all just a little bit different ...
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Agency SBIR/STTR Differences

• RD Topic Areas
• Dollar Amount of Award (Phase I and II)
• Receipt Dates / Number and Timing of
  Solicitations
• Proposal Review Process
• Proposal Success Rates
• Type of Award (Contract or Grant)
• Many other details
• Profit or fee allowed
• Phase I to Phase II gap funding
• Payment types and schedule

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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.
• P.I.s primary employment with small
• business during project
• 500 or fewer employees

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STTR PROGRAM

• FORMAL COOPERATIVE RD EFFORT
• Minimum 40 by small business
• Minimum 30 by research institution
• U.S. RESEARCH INSTITUTION
• College or University other non-profit
  research
• organization federal RD center
• PRINCIPAL INVESTIGATOR FROM SMALL
• BUSINESS and/or RESEARCH INSTITUTION
• AWARD MADE TO SMALL BUSINESS

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SBIR/STTR 3-Phase Program

• PHASE I
• Feasibility study
• (no preliminary data needed)
• 100K and 6 months (SBIR) or 12 months(STTR)
• PHASE II
• Full R/RD
• 2-Year Award and 750K (SBIR) or 500K (STTR)
• PHASE III
• Commercialization Stage
• Without SBIR Support

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Some 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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National Institutes of Health
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
• Improve research tools/ reduce cost of research
• Help in training of research investigators
• Increase health knowledge base

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SBIRs vs. STTRs NIH UNIQUE FEATURES SBIR
STTR Set-Aside of NIH Budget 2.5
0.15 FY00 NIH SBIR/STTR Budget 352.1. M
21 Million Award Guidelines Phase I
100K/6mos 100K/12 mos. Phase II
750K/2 yrs 500K/2 yrs Subcontracts Phase
I lt33 lt60 Phase II lt50
lt60 Academic Component Not Required
gt30 Business Employment of PI gt50 w/ SBC
SBC or RI
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SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

• SBIR 2/3 project by small business - Phase I
• 1/2 project by small business - Phase II
• STTR 40 work by small business and
• 30 work by research institution
• SBIR PIs primary employment must be with
• small business concern
• STTR PI can be from research institution or
• small business concern

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NATIONAL INSTITUTES OF HEALTH SBIR/STTR PROGRAM

• Major Changes for FY 2000
• Single SBIR/STTR Solicitation
• Coincident Grant Receipt Dates
• April 1, August 1, December 1
• Special Announcements
• NIH Guide for Grants and Contracts
• Review Criteria

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NATIONAL INSTITUTES OF HEALTH
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National Institutes of Health
Office of the Director
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 Diabetes and Digestive
and Kidney Diseases
National Institute of Dental and Craniofacial Rese
arch
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 Center for Complementary and
Alternative Medicine
National Library of Medicine
Fogarty International Center
National Center for Research Resources
Center for Information Technology
Center for Scientific Review
Clinical Center
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Who Speaks for NIH?
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WHAT RESEARCH AREAS ARE OF INTEREST TO NIH?

• Topics listed for each awarding component in
  SBIR/STTR Solicitation
• Innovative investigator-initiated research
  projects that relate to the mission of the
  awarding component

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Cutting-Edge Technologies

• Nanotechnologies
• Bioinformatics
• Proteomics
• Caged molecules
• Genetically engineered proteins
• Combinatorial approaches
• Biosilicon devices
• Biocompatible biomaterials
• Acousto-optics and opto-electronics
• Imaging technologies

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Programs success is dependent upon...

• Flexibility

• Communication

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• NATIONAL INSTITUTES OF HEALTH
• SBIR/STTR PROGRAM
• Flexibility

• Award Mechanisms
• Grants (95) Assistance mechanism
• Contracts (5) Procurement mechanism
• Receipt dates
• SBIR/STTR Grant Applications April 1
• Ph I or Ph II accepted on any August 1
• of 3 receipt dates December 1
• Contract Proposals First week of November

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• NATIONAL INSTITUTES OF HEALTH
• SBIR/STTR PROGRAM
• Flexibility (cont.)

• Topics Not intended to be
• exhaustive (grants)
• Award amount Guidelines Be realistic
• and duration
• Submissions 3 (original 2 revisions)

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NATIONAL INSTITUTES OF HEALTH SBIR/STTR
PROGRAM Communication

• NIH Program Director
• Guidance and Advice
• Review Issues Dos and Donts
• Answer your questions
• New/ emerging scientific interests
• Talk about funding alternatives

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NATIONAL INSTITUTES OF HEALTH SBIR/STTR
PROGRAM Communication (cont.)

• Program and Grants Management
• Post-award advice/guidance
• supplemental funding
• financial tracking systems
• Success stories
• Phase III products

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NIH SMALL BUSINESS FUNDING OPPORTUNITIES WEBSITE
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http//grants.nih.gov/grants/ funding/sbir.htm

• SBIR and STTR Solicitation and
  Forms/Instructions
• SBIR/STTR Policy Information
• Invention Reporting Requirements
• Information For New Grantees
• SBIR and STTR Award Data (Including Abstracts)
• Special Announcements (PAs and RFAs)
• Other Small Business Sites of Interest
• Financial Questionnaire Evaluation of
  Financial
• Management System
• SBIR/STTR Conferences
• SBIR/STTR Success Stories
• Review of Small Business Research Applications

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http//grants.nih.gov/grants/funding/sbir.htm
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NIH Guide Program Announcements (PAs) Requests
for Applications (RFAs)
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(No Transcript)
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http//grants.nih.gov/grants/funding/sbir.htm
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The NIH SBIR/STTR Application Process A closer
look ..
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NIH SBIR/STTR APPLICATION PROCEDURES

• Up to 100,000 Total Costs
• Omit Detailed Budget Form Pg. 3
• Include Narrative Justification
• Personnel
• Fixed Fee
• Consultant Costs
• Contractual Costs

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NIH SBIR/STTR APPLICATION PROCEDURES (cont.)

• Above 100,000 Total Costs
• Include Budget Details
• Narrative Justifications
• Same as Current Practice
• All Forms required

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Applications Submitted to NIHCenter for
Scientific Review

• Approximately 40,000 grant applications are
  submitted to NIH each year, of which 25-30 are
  funded
• Competing grant applications are received for
  three review cycles per year

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NIH Grant Applications Submitted to Center for
Scientific Review

• One Central Receipt Point
• One Address
• Regardless of the awarding component(s) that
  might fund the application

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SBIR/STTR Grant Applications are submitted to
the NIH Center for Scientific Review.

• Open envelopes Read your cover letter
• Assign applications to study sections
• Assign applications to potential funding
  components
• Capture administrative data for NIH information
  management system

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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) that
  would be in conflict

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Dual Review System for Grant Applications

• Second Level of Review
• Council
• Assesses quality of SRG review of grant
  applications
• Makes recommendation to Institute Staff on
  funding
• Evaluates program priorities and relevance
• Advises on policy

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NATIONAL INSTITUTES OF HEALTHSBIR FAST-TRACK
Standard application, review, award process
Fast-Track review option
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NATIONAL INSTITUTES OF HEALTHSBIR FAST-TRACK
PARALLEL REVIEW OPTION

• Funding gap eliminated or reduced
• Requirements
• Clear, measurable milestones in Phase I
• Product Development Plan
• (Ph II Appendix)

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NIH SBIR Review Criteria

• Scientific and Technical Merit based on.
• Significance
• Commercial Potential?
• Anticipated commercial and societal benefits?
• Advancement of scientific knowledge?
• Approach
• Innovation
• Investigators
• Environment

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NIH SBIR Review Criteria

• Other factors considered.
• Safeguards for animal and human subjects
• Appropriateness of the budget
• Justify costs that deviate from the guidelines!

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NIH SBIR Review Criteria (cont.)

• Phase II Standard review criteria and degree to
  which Phase I feasibility was demonstrated
• Fast Track (Phase I/Phase II)
• Specification of clear, measurable goals to be
  achieved prior to initiating Phase II
• Concise Product Development Plan
• Extent to which applicant was able to obtain
  letters of interest, additional funding
  commitments and/or resources from non-SBIR/STTR
  funding sources that would enhance the likelihood
  for commercialization

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Streamlined Procedures of NIH Grant Application
Review

• Reviewers
• Rate applications 100-500 priority score
• Discuss at review applications identified between
  100 and 300
• Triage/ UNscore applications between
• 300-500. generally
• Applicants ALL
• Automatically receive essentially verbatim
• written critiques (Summary Statements)

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Post Review Next Steps

• Read the summary statement
• Re-read the summary Statement
• Contact your Program Director
• Guidance and advice
• Discuss options

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Common Problems with Applications

• Inadequately defined test of feasibility
• Diffuse, superficial, or unfocused research plan
• Lack of sufficient experimental detail
• Questionable reasoning in experimental approach
• Uncritical approach
• Failure to consider potential pitfalls and
  alternatives
• Lack of innovation
• Unconvincing case for commercial potential or
  societal impact
• Lack of experience with essential methodologies
• Unfamiliar with relevant published work
• Unrealistically large amount of work proposed

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NIH Allows Amended Applications

• Two amended applications allowed
• Generally half of the reviewers are new
• Request for change of reviewers must be supported
• An opportunity to revise and improve your
  application

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• BECOME AN NIH CONSULTANT
• Request Consultant Information
• Form (CIF)
• E-mail cn3_at_cu.nih.gov
• Fax [phone]
• Write NIH Consultant File
• 7101 Wisconsin Ave.
• Suite 1125
• Bethesda, MD 20814-5228

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NATIONAL INSTITUTES OF HEALTHSBIR/STTR
REVIEW/AWARD PROCESS
SBIR/STTR Scientific/Technical Adv
Council Awd Receipt Dates Peer
Review Board Review Date Apr 1, 2000
June/July Sept/Oct Nov Aug 1, 2000
Oct/Nov Jan/Feb Mar Dec 1, 2000
Feb/March May/June July
90-Day pre-award costs are allowable At your
own risk..
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NATIONAL INSTITUTES OF HEALTHSBIR/STTR FUNDING
RATES for FISCAL YEAR 1999
324
45.4
58
829
19
34.9
78
Success Rate ()
27.9
27.2
1
23.1
14.3
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NATIONAL INSTITUTES OF HEALTHSBIR/STTR AWARD
DATA(dollars in millions)
FY 1998 FY 1999 Number
Dollars Number Dollars
1,313 (23) 123
265.6 ( 6.2) 17. 2
1,439 (58) 119
SBIR Fast-Track STTR Totals
307.0 ( 10.2) 19.7
1,436
282.8
1,558
326.7
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NATIONAL INSTITUTES OF HEALTHSBIR/STTR FY2000
AWARD DATA (estimates)
Type Awards Amount
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Congratulations!The check is in the mail
(almost)
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WHERES THE MONEY?

• WHY THE AWARD MAY BE DELAYED
• OPRR Issues
• IRB (Human Subjects)
• http//grants.nih.gov/grants/oprr/lib
  rary_human_t.htm
• IACUC (Animal Involvement)
• http//grants.nih.gov/grants/oprr/lib
  rary_animal_t.htm
• EIN (Entity Identification Number)
• Third Party Involvement
• Contracts, Consortia, Consultants

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UNDERSTAND THE BUSINESS ASPECTS

• Roles and Responsibilities
• Financial Management Systems
• Post Award Administration
• Reporting Requirements

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SBIR/STTR TIPS CHECKLIST

• Get to know your agency Program Manager
• Understand agencys mission needs
• Read solicitation and follow instructions
• Do not depend solely on SBIR funding
• Dont go it alone
• Have an outcome
• Be PERSISTENT

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Top 10 Reasons to Seek SBIR/STTR Funding
Opportunities

• 1. Over 1.2 Billion available
• 2. Seed money to fund high risk
• projects
• 3. Job creation
• 4. Promote and foster partnerships
• with collaborators (e.g., academia)

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Top 10 Reasons to Seek SBIR/STTR Funding
Opportunities (cont.)

• 5. Intellectual property rights normally
• retained by small business
• 6. NOT A LOAN - no repayment
• 7. Large corporations look to small companies
  for initial development of embryonic technology

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Top 10 Reasons to Seek SBIR/STTR Funding
Opportunities (cont.)
8. Recognition, verification and
visibility 9. Potential leveraging tool to
attract venture capital/other sources of
10. Small business concerns
increasingly recognized as unique
national resource of technological
innovation!
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When opportunity doesnt knock Build doorways.
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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
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NIH Program Activities and Areas of
Research (cont.)
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
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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-- treatment of drug addiction behavioral
strategies for treatment medication training in
drug abuse treatment techniques drug abuse
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
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NIH Program Activities and Areas of Research
(cont.)
NIHGRI-- efforts toward achieving the goals of
the Human Genome Project (Science vol. 262,
pp.43-46 Oct. 1, 1993)
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 research-related issues (e.g., models,
methods)
NLM-- innovative methods, systems, and services
for managing health knowledge and information
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For more information..

• Contact individual agency websites

• Cross-agency website
• http//www.zyn.com/sbir

• Conferences / workshops
• Topic search engine for all agency
• solicitations