SOURCES SOUGHT
A -- Exhaled Nitric Oxide Dose-Response Study
- Notice Date
- 5/4/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-FDA-SOL-06-00205
- Description
- The Food and Drug Administration (FDA) has a requirement for a study on Exhaled Nitric Oxide (eNO) Dose-Response. This announcement is a Sources Sought Synopsis. Its purpose is to generate responses from qualified 8(a), HUBZONE, veteran owned, or small business concerns, which have the interest and the ability to perform a study intended to evaluate the exhaled nitric oxide (eNO) dose-response of asthmatic patients. The NAICS code for this procurement is 541710. Contractors interested in this requirement must submit a capability statement. Capability statements should include a description of your organization?s experience and ability to respond to the objective of the study which is eNO, a marker of airway inflammation which is a potential pharmacodynamic endpoint for evaluating the delivery of inhaled corticosteroids (ICS) to the lung. The proposed study is intended to evaluate eNO dose-response. Design aspects include: examine the magnitude of dose-response for fluticasone propionate ICS using eNO as a marker of drug response; examine subject screening criteria for study enrichment; examine intra subject variability, which in combination with the magnitude of dose-response, will allow estimation of the number of patients required in a BE study; and examine the dose duration and washout period needed between doses that gives the most significant dose-response. The study has been divided into two phases. Phase I shall evaluate a dose of 200 mcg/day (dosed as 100 mcg twice daily) during and after the treatment phase. As part of the study, patient?s eNO will be monitored to evaluate how long it takes for eNO levels to return to near-baseline levels. Phase II shall be a four way crossover study with suggested doses of 100,200, and 800 mcg/day, dosed twice daily, and a replicate 200 mcg/day dose, dosed twice daily. The washout period between doses will be determined from the results of Phase I. Placebo doses will be used to blind subjects to dose. The FDA anticipates a two year contract will be awarded. Interested contractors shall provide (1) a summary list of similar work previously performed or being performed; (2) a brief statement of project accomplishments which state the outcomes and impacts of these activities; (3) the professional qualifications and specific experience of staff who may be assigned to the requirement; (4) description of your facility required including laboratory space, analytical instrumentation, and access to an IRB; and (5) resumes for proposed key personnel should be included in the capability statement, if available; (6) any other specific and pertinent information as pertains to this Sources Sought that would enhance FDA?s consideration and evaluation of the information submitted. Responses must reference Request for Information (RFI) FDA-SOL-06-00205 and include the following: (1) name and address of firm, (2) type of business (i.e.: small business, small disadvantaged 8(a) certified, HUBZONE, woman-owned small business, small disadvantaged business (not 8(a) certified), veteran-owned small business, disabled veteran owned business, etc.) (3) two points of contact: name, title, phone, fax and e-mail, (4) DUNS number, (5) NAICS codes, (6) contractor?s capabilities statement which provides the information stated above, (7) list of customers covering the past 5 years including a summary of similar such work, by contract number, contract type, dollar value for each customer, reference and customer point of contact with phone number, and identify your role as either the prime contractor or subcontractor and (8) a statement that the contractor has registered in the central contractor registration (ccr) data base (http://www.ccr.gov). THIS SYNOPSIS IS FOR INFORMATION AND PLANNING PURPOSES AND IS NOT TO BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT AND ANY FOLLOW-UP INFORMATION REQUESTS. RESPONDENTS WILL NOT BE NOTIFIED OF THE RESULTS OF THE EVALUATION. ALL INFORMATION SUBMITTED IN RESPONSE TO THIS ANNOUNCEMENT MUST ARRIVE ON OR BEFORE THE CLOSING DATE. THE CLOSING DATE FOR RESPONSES IS MAY 19, 2006, NO LATER THAN 4:00 p.m. RESPONSES SHALL BE SUBMITTED BY EMAIL, COURIER, OR U.S. POSTAL SERVICE TO: Megan Gnall, Contracting Officer megan.gnall@fda.hhs.gov Food and Drug Administration, OSS/OAGS/DCGM/CO 5630 Fishers Lane, Room 2102, HFA-500 Rockville, Maryland 20857-0001. Phone 301-827-7167 If submitting via U.S. Postal Service or Courier, submit an original and two copies to the addresss stated above.
- Record
- SN01040839-W 20060506/060504220518 (fbodaily.com)
- Source
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