Small Business Innovation Research (SBIR) Program Contract Solicitation (PHS 2011-1) Now Available

Notice Number: NOT-OD-10-124

Key Dates
Release Date:  August 18, 2010
Contract Proposal Receipt Date:  November 8, 2010

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 2011-1) with a receipt date of November 8, 2010; 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.

New to this year’s contract solicitation is the inclusion of two NIH Technology Transfer (TT) topics from the National Cancer Institute. These topics are:

NCI 298: Low-Field Electron Paramagnetic Resonance Imaging Device to Optimize Development of Anti-Angiogenic Therapeutics in Cancer Animal Models (NIH TT), and

NCI 299: A New Type of Vaccine for Prevention of HIV Infection and HIV-Associated Cancers (NIH TT)

The goal of the NIH TT pilot is for small companies to transition discoveries/inventions from NIH’s intramural research program by licensing the technologies for further research and R&D and develop them into commercial products that benefit the public. Selected contractors will work closely with the NIH inventors of the technologies.

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 2010 is $616 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 $150,000 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 $1,000,000 for direct costs, F&A costs, and negotiated fixed fee for a period generally not to exceed two years. 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 2011-1 Solicitation:

National Institutes of Health (NIH)

National Cancer Institute (NCI)
255 Development of Anticancer Agents
277 Companion Diagnostics: Predictive And Prognostic Tests Enabling Personalized Medicine In Cancer Therapy
283 Development of a Molecular Diagnostic Assay to Detect Basal-like Breast Cancer
284 Alternative Biospecimen Stabilization And Storage Solutions
291 Radioprotector/Mitigator Development to Decrease Normal Tissue Injury During Radiotherapy
292 Development of Molecular Pharmacodynamic Assays for Targeted Therapies
293 Development of Devices for Point of Care Analysis of Circulating Tumor Cells
294 Development of Glycosylation-Specific Research Reagents (Antibodies and Aptamers)
295 Algorithms for Automated Quantitative Imaging of Tumor Microenvironment
296 Systems for Automated Storage, Analysis, and Reporting of Objective Behavioral Exposures
297 Methods and Tools for Quantitatively Measuring Non-Coding RNAs in Cancer Early Detection, Prediction, and Diagnosis
298 Low-Field Electron Paramagnetic Resonance Imaging Device To Optimize Development Of Anti-Angiogenic Therapeutics In Cancer Animal Models (NIH TT)
299 A New Type of Vaccine for Prevention of HIV Infection and HIV-Associated Cancers (NIH TT)
300 Therapeutics and Theranostics Based on Nanotechnology
301 Nanotechnology Sensing Platforms for Improved Diagnosis of Cancer
302 Development of Clinical Automated Multiplex Affinity Capture Technology for Detecting Low Abundance Cancer-related Proteins/Peptides
303 Development of Quantitative Multiple Reaction Monitoring Mass Spectrometry Assays for the Detection of Cancer Related Aberrant Proteins/Peptides
304 Development of blood-based Methods for the Detection of Cancer Recurrence in Post-Therapy Breast Cancer Patients
305 Novel Digital X-ray Sources for Cancer Imaging Applications
306 Development of Innovative Algorithms/Software for Processing & Analysis of In Vivo Images in Oncology
307 Novel Imaging Agents to Expand the Clinical Toolkit for Cancer Diagnosis, Staging, and Treatment

National Center for Complementary and Alternative Medicine (NCCAM)
001 Develop analytical methodologies to validate label claims for the most commonly used botanicals and dietary supplements
002 Comprehensive biological and phytochemical analysis of Harpagophytum procumbens (Devil’s Claw)

National Center for Research Resources (NCRR)
012 Visualizing Biomedical Research Characteristics
014 Equipment, Supplies and Chemical Solutions Required for High-throughput Cryopreservation of Sperm from Biomedical Model Fishes

National Heart, Lung and Blood Institute (NHLBI)
043 Development of Pathogen Inactivation Technologies for Blood Components
057 Point-of-Care Assay for Engraftment Potential of Umbilical Cord Stem Cells
058 Novel Technologies for Powering Ventricular Assist Devices
059 Informatics Tools and Services to Support Data Sharing and Distribution for Cardiovascular, Lung, and Blood Researchers
060 Interventional MRI and X-ray Invasive Hemodynamics Telemetry
061 Novel Concepts in Safe “Active” Transmission Lines for MRI Catheters
062 Strategy for Finding Cases of Moderate-to-Severe COPD
063 Reagents for Studying Human Lung Cell Biology and Cellular Function

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
042 Interventions to Prevent and Treat Substance Abuse Among Children, Adolescent and Adults with FASD
043 Medications Development for the Treatment of Alcohol Use Disorders and Alcohol-Induced Tissue Damage

National Institute on Drug Abuse (NIDA)
122 Tool Development for New or Improved Capture Reagents
123 Development of alternate drug delivery dosage forms for drugs abuse studies
127 Improving Measures of Addiction Risk
128 Video Game Targeting Relapse Prevention in Youth with Substance Use Disorders
129 Developing implementation packages for evidence-based HIV prevention intervention materials for drug users
130 Developing, validating, refining tools for ecologic momentary assessment
131 E-Technology Tools for Extending the Reach of Prevention Interventions in Rural and Remote Locations
132 Development of a Device for Auto-administering Naloxone to Overcome Overdose
133 Development of a Device to Assess Hyperalgesia at the Bed Side by the Cold Pressor Test
134 Screening, Characterization and Validation Assays for Protein Capture Reagents
135 Development of New Methods and Approaches to Monitor Medication Compliance in Clinical Trials
136 New Techniques for the Large Scale Production and Purification of Antibodies or Vaccines for the Treatment of Substance Use Disorders
137 Rapid portable devices to measure drug use
138 Real-time activity as a potential diagnostic marker for pain or drug-craving
139 Confirming Compliance with Experimental Pharmacotherapy Treatment of Drug Abuse

National Institute of Environmental Health Sciences (NIEHS)
113 Application of ‘Omics' Technologies to Rodent Formalin-Fixed, Paraffin Embedded Tissue Samples
114 High Throughput Screening for Reactive Oxygen Species Mediating Toxicity
115 In Vitro 3D Tissue Models for Toxicity Testing
116 Development of Improved Biomarkers as Earlier Humane Endpoints for Ocular Safety Assessments
117 Development of Sensitive Innovative Methods for Detecting and Assessing Pain and Distress in Laboratory Animals Used in Toxicological Research and Testing

Centers for Disease Control and Prevention (CDC)
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)
032 Improving utilization of screening tests for colorectal, breast and cervical cancers

National Center for HIV/AIDs, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
030 Development of a Non-Invasive Method of Accurate Blood Glucose Determination

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 2011-1). 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 2011-1 (PDF [http://grants.nih.gov/grants/funding/SBIRContract/PHS2011-1.pdf] or MS Word [http://grants.nih.gov/grants/funding/SBIRContract/PHS2011-1.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. Anita Hughes
Phone: (301) 435-3805
Fax: (301) 480-0309
Email: anita.hughes@nih.gov

National Center for Complementary and Alternative Medicine (NCCAM)

Ms. Anita Hughes
Phone: (301) 435-3805
Fax: (301) 480-0309
Email: anita.hughes@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 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 (CDC)

For general administrative SBIR program questions, contact:
Dr. Paul Smutz
Office of Extramural Research
Office of the Associate Director for Science
Phone: (404) 639-4783
Fax (404) 639-4903
Email: wsmutz@cdc.gov

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

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)

Julio Lopez
Contracting Officer
Phone: (770) 488-2892
Fax: (770) 488-2868
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 2010-2). There is one grant application due date (December 5, 2010) remaining for calendar year 2009.

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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