Notice Number: NOT-OD-09-137

Key Dates
Release Date:  August 19, 2009
Contract Proposal Receipt Date:  November 9, 2009

Issued by
National Institutes of Health (NIH) (www.nih.gov)
Centers for Disease Control and Prevention (CDC) (www.cdc.gov)

Innovative technologies and methodologies fuel progress in biomedical and behavioral research and represent an increasingly important area of the economy. The Small Business Innovation Research (SBIR) program provides support for research and development (R&D) of new or improved technologies and methodologies that have the potential to succeed as commercial products.

The purpose of this notice is to (1) announce the issuance of the Solicitation of the National Institutes of Health and the Centers for Disease Control and Prevention for Small Business Innovation Research Contract Proposals (PHS 2010-1) with a receipt date of November 9, 2009; and (2) inform the public about the opportunities that the SBIR program offers to small business concerns as well as to scientists at research institutions. 

The SBIR legislation requires the Public Health Service (PHS), Department of Health and Human Services, and certain other Federal agencies to reserve 2.5 percent of their extramural research or R&D budgets for an SBIR program. (The NIH SBIR set-aside requirement for FY 2009 is $599.9 million.)

The offeror organization must be a small business concern as defined by the Small Business Administration and described in the Contract Solicitation. The primary employment of the principal investigator MUST be with the small business concern at the time of award and during the conduct of the proposed project. In accord with the intent of the SBIR program to increase private sector commercialization of innovations derived from Federal R&D, scientists at research institutions can play an important role in an SBIR project by serving as consultants and/or subcontractors to the small business concern.  Generally, up to one-third of the Phase I budget may be spent on consultant and/or subcontractual costs, and, generally, up to one-half of the Phase II budget may be spent on such costs. In this manner, a small business concern with limited expertise and/or research facilities may benefit from teaming with a scientist(s) at a research institution; for the scientist(s) at a research institution, this team effort provides support for R&D not otherwise obtained. The SBIR program consists of the following three phases:

PHASE I: The objective of this phase is to determine the scientific and technical merit and feasibility and potential for commercialization of the proposed research or R&D efforts and the quality of performance of the small business concern, before consideration of further Federal support in Phase II. Generally, Phase I SBIR awards do not exceed $100,000 for direct costs, Facilities and Administrative (F&A) costs, and negotiated fixed fee for a period generally not to exceed six months.

PHASE II: The objective of this phase is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I and the scientific and technical merit and commercial potential of the Phase II proposal. Only Phase I contractors are eligible to apply for Phase II funding, and Phase II proposals may be submitted ONLY upon the request of the Contracting Officer. (However, see "Fast-Track" Initiative below.) Generally, Phase II awards do not exceed $750,000 for direct costs, F&A costs, and negotiated fixed fee for a period generally not to exceed two years. That is, generally, a two-year Phase II project does not cost more than $750,000 for that project. Only one Phase II award may be made for any SBIR project.

PHASE III: The objective of this phase is for the small business concern to pursue, with non-SBIR funds, the commercialization of the results of the research or R&D funded in Phases I and II.

"FAST-TRACK" INITIATIVE: (Applicable only to proposals submitted to the NIH and only if an awarding component indicates that it is accepting Fast-Track proposals for a particular topic.)

The Fast-Track initiative is an opportunity for small business concerns to submit both a Phase I and Phase II proposal for concurrent peer review. This initiative also has the potential to minimize any funding gap between Phase I and Phase II. Proposals must be prepared in accordance with Phase I and Phase II proposal preparation instructions.

Following are the research topics contained in the PHS 2010-1 Solicitation:

National Institutes of Health (NIH)

National Cancer Institute (NCI)
255       Development of Anticancer Agents
257       Biopsy Instruments and Devices that Preserve Molecular Profiles in Tumors
258       Innovative Devices to Protect Radiosensitive Organs and Structures During Radiation Therapy
271       Development of Molecular Pharmacodynamic Assays for Targeted Therapies
272       Point of Care Analysis of Circulating Tumor Cells for Cancer Diagnostics, Prognosis and Treatment
273       Process Analytic Technologies (PAT) for Biologics: Innovative methods for monitoring and analyzing product quality and safety during manufacture of cancer therapeutics
274       Quantitative Cell-Based Imaging For Clinical Diagnosis and Treatment
275       Development of Generic Antibodies for the Treatment of Cancer
276       Development of Novel Medicinal Food Products for the Mitigation of the Side-Effects of Cancer Chemotherapy
277       Companion diagnostics: predictive and prognostic tests enabling personalized medicine in cancer therapy
278       Data harmonization and advanced computation of population health data
279       Facilitating the Transfer of Statistical Methodology into Practice
280       Direct sequencing of nucleic acids without clonal amplification or synthesis for the molecular characterization of cancer
281       Biosensors for Early Cancer Detection and Risk Assessment
282       Imaging of Cancer Stem Cells
283       Development of a Molecular Diagnostic Assay to Detect Basal-like Breast Cancer
284       Alternative Biospecimen Stabilization and Storage Solutions
285       Multifunctional Therapeutics and Theranostics Based on Nanotechnology
286       Nanotechnology Imaging Agents or Devices for Improved Detection of Cancer
287       Nanotechnology Sensing Platforms for Improved Cancer Detection
288       Development of Alternative Affinity Capture Reagents for Cancer Proteomics Research
289       Physical Property-Based High-Throughput Protein Sequencing
290       siRNA Resource for Synthetic Lethal Screening of DNA repair and damage signaling networks

National Center for Research Resources (NCRR)
012       Visualizing Biomedical Research Characteristics
013       Collecting, Integrating, Accessing and Using Disease Models-Related Data

National Heart, Lung and Blood Institute (NHLBI)
051       Technologies for In Vivo Electrophysiology Studies in Transgenic and Knock Out Mice and Other Small Animals
052       Protein Capture Agents for Cardiovascular Research
053       Innovative Tools, Techniques, and Software for the Screening, Recruitment, and Follow-up of Participants in Pediatric Research
054       Interventional MRI and X-ray Invasive Hemodynamics Telemetry
055       Catheter for Delivering High Intensity Focused Ultrasound for Transluminal and Endocavitary Interventional MRI
056       Development of Blood Donor Screening Tests for the Presence of Human Babesia Microorganisms

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
036       Identification of miRNAs as Biomarkers for Alcohol-Induced Disorders
037       Real-time Detection of Neurochemical Changes in Response to Alcohol Drinking
038       Biomarkers for Alcohol-Induced Disorders
039       Human stem cells as a model for understanding and treatment of alcohol induced tissue damage
040       Alcohol Biosensors and Data Analysis Systems
041       Generation of Rat Knockout Strains for Alcohol Research

National Institute of Allergy and Infectious Diseases (NIAID)
018       Aminoglycosides: Formulation for Oral Delivery
019       High Throughput in Vitro Immunization System For Evaluating Human B Cell Immune Responses to HIV-1 Vaccine Antigens
020       In Vitro Immunization System For Evaluating Human T Cell Immune Responses to HIV-1 Vaccine Antigens

National Institute on Drug Abuse (NIDA)
113       New Technologies: Integrating data from Prescription Monitoring Program(s) to Current Clinical Practice 
114       Development of Innovative Techniques/Tools for the Screening, Recruitment, and Follow-up of Clinical Trial Participants 
115       Innovative Diagnostic Drug Screening Tests for Drug of Abuse
116       Marketing Evidence-Based Prevention Interventions for Substance Abuse Prevention
117       Using Handheld Devices to Support Recovery
118       Tools to Promote Security and Appropriate Prescribing of Scheduled Prescription Drugs
119       Innovative Technologies to Support Economic Research in the Drug Abuse Treatment System
120       Development of State-of-the-Art Mechanisms for Epidemiological Research
121       Rapid and Sensitive Method for Nicotine and Its Metabolites in Biological Fluids
122       Tool Development for New or Improved Capture Reagents
123       Development of alternate drug delivery dosage forms for drugs abuse studies
124       Design and Synthesis of Treatment Agents for Drug Abuse
125       Pharmaceutical Approaches for Development of Pharmacotherapies for Drug Addiction 
126       Web Based Cognitive/Neuropsychological Testing for Substance Abuse

National Institute of Environmental Health Sciences (NIEHS)
105       Computer Assisted Sperm Analysis System
106       Development of Quantitative High Throughput Screens For Environmental Toxicants that Induce DNA Damage
107       Development of Mid to High-Throughput Toxicological Tests Using Model Organisms
108       Integrated Prediction Systems to Support Environmental Toxicological Assessments
109       Incorporation of Metabolism into Quantitative High Throughput Screening( HTS) Assays
110       Development of Quantitative High Throughput Screens for the Detection of Chemicals That Modulate Gap Junctional Intercellular Communication
111       Monitoring in vivo Gene Expression Changes After Exposure to Toxicants in Caenorhabditis elegans
112       Development of Biomarkers for Assessment of Exposure to Molds

Centers for Disease Control and Prevention (CDC)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)
031       Development of a Method to Detect Traces of Natural Rubber and Silicone in Biological Specimens

National Center for HIV/AIDs, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
027       Manufacture of a Novel Technology to Identify Early HCV Infection by anti-HCV Detection
028       An Integrated Relational Database Storage and Data Mining Software for Large-Scale Analyses of Infections Caused by Hepatitis Viruses
029       Decision Support Tools and the Electronic Health Record (EHR)

National Center for Immunization and Respiratory Diseases (NCIRD)
023       Novel Methods for Detecting Viruses in Clinical Samples
024       Novel or Enhanced Technology for Vaccination Delivery and Immunization Programs

National Center for Zoonotic, Vector-Borne & Enteric Diseases (NCZVED)
001       Development of Soaps or Lotions Containing Natural Product Repellents or Toxicants for Tick and Mosquito Disease Vectors
002       Novel Methods for Detecting Parasites in Clinical Samples

Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER)
002       Computer-Based Models For Evaluating Strategies and Outcomes in Pandemic Preparedness
003       Development of an Improved Reusable Insulated [Cold-Chain] Shipping Container (ISC)
004       Training in Public Health Ethics for Public Health Responders
005       State, Local, Community and Faith Based Tools and Resources for Protecting Vulnerable Populations from Excess Health Burden During All-Hazards Events
006       Pre-Hospital Transport Vehicle for the Acutely Injured
007       Technologies for Rapid and Efficient Communication in Emergency Response

Inquiries

Eligibility requirements, definitions, submission procedures, review considerations, contract proposal forms and instructions, and other pertinent information, including the "Fast-Track" Initiative, are contained in the Solicitation (PHS 2010-1). The Solicitation, including contract proposal forms, is available electronically through the NIH "Small Business Research Funding Opportunities” Web site. See SBIR Phase I Contract Solicitation PHS 2010-1 (PDF [https://grants.nih.gov/grants/funding/SBIRContract/PHS2010-1.pdf] or MS Word [https://grants.nih.gov/grants/funding/SBIRContract/PHS2010-1.doc]). Be sure to use the appropriate CONTRACT PROPOSAL forms as they differ from the SF424 (R&R) GRANT application forms.

Note: The SBIR Phase I Contract Solicitation is available ONLY via electronic means. Potential offerors are encouraged to check the NIH Small Business Research Funding Opportunities Web site for updates on the program. Any updates or corrections to the Solicitation will be posted there.

Contracting Officers  

Any small business concern that intends to submit an SBIR contract proposal under this Solicitation should provide the appropriate contracting officer(s) with early, written notice of its intent, giving its name, address, e-mail, telephone, and topic number(s). If a topic is modified or canceled before the Solicitation closes, only those companies that have expressed such intent will be notified.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Ms. Mary Landi-O’Leary      
Phone: (301) 435-3807
Fax: (301) 480-0309
Email: ml186r@nih.gov

National Center for Research Resources (NCRR)

Mr. John Taylor
Phone: (301) 435-0327
Fax: (301) 480-3430
E-mail: taylorjc@nhlbi.nih.gov
National Heart, Lung, and Blood Institute (NHLBI)
Mr. John Taylor
Phone: (301) 435-0327
Fax: (301) 480-3338
E-mail: taylorjc@nhlbi.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Mr. Matthew Packard
Phone: (301) 443-3041
Fax: (301) 443-3891
Email: packardm@mail.nih.gov
National Institute of Allergy and Infectious Diseases (NIAID)

Mr. Peter Jackson
Phone: (301) 496-8426
Fax: (301) 480-2310
Email: pj8v@nh.gov

National Institute on Drug Abuse (NIDA)

Mr. Brian O’Laughlin
Phone: (301) 443-6677
Fax: (301) 443-7595
Email: bo50d@nih.gov

National Institute of Environmental Health Sciences (NIEHS)

Ms. Velvet M. Torain
Phone: (919) 541-0400
Fax: (919) 541-2712
Email: torain@niehs.nih.gov

Centers for Disease Control and Prevention

For general administrative SBIR program questions, contact:

Dr. Paul Smutz
Office of Public Health Research (OPHR)
Office of the Chief Science Officer
Phone: (404) 639-4783
Fax (404) 639-4903
Email: wsmutz@cdc.gov

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)

Mrs. Theresa Routh-Murphy
Contracting Officer
Phone: (770) 488-2713
Fax: (770) 488-2778
Email: TNR3@cdc.gov

National Center for HIV/AIDs, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)

Mr. Julio Lopez
Contracting Officer
Phone: (770) 488-2892
Fax: (770) 488-2868
Email: jlopez3@cdc.gov

National Center for Immunization and Respiratory Diseases (NCIRD)

Ms. Nancy Norton
Contracting Officer
Phone: (770) 488-2056
Fax: (404) 488-2777
Email: nnorton@cdc.gov

National Center for Zoonotic, Vector-Borne & Enteric Diseases (NCZVED)

Ms. Nancy Norton
Contracting Officer
Phone: (770) 488-2056
Fax: (404) 488-2777
Email: nnorton@cdc.gov

Coordinating Center for Terrorism Preparedness and Emergency Response (COTPER)

Vivian Hubbs
Contracting Officer
Phone: (770) 488-2647
Fax: (770) 488-2670
Email: vhubbs@cdc.gov

Those interested in the PHS small business research GRANT programs, where investigator-initiated research ideas are encouraged, are invited to access the Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications (PHS 2009-2). There is one grant application due date (December 5, 2009) remaining for calendar year 2009.

To understand better the differences between grants and contracts, see Contracts vs. Grants: What's the difference?

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