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FBO DAILY ISSUE OF AUGUST 30, 2009 FBO #2836
SOLICITATION NOTICE

B -- Maintain Data Registry

Notice Date

8/28/2009
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

813920 — Professional Organizations
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-09-1232
 

Point of Contact

Karen R. Petty, Phone: 301-827-8774
 

E-Mail Address

karen.petty@fda.hhs.gov
(karen.petty@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 813920, is to notify contractors that the Food and Drug Administration (FDA) is seeking competition of this requirement in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. Under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-35. This synopsis is designated for Full and Open competition for a firm fixed-price purchase order. Any small business firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services, which will be considered if received by the second (2nd) calendar day following the appearance of this announcement. Prospective offerors are responsible for monitoring the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to maintain data registry. Statement of Work: Bronchoscopy Interventional and Diagnostic Registries: Monitor Device Safety for the Treatment or Diagnosis of Respiratory Conditions Bronchoscopy aids in the diagnosis and treatment of various respiratory conditions. More than 500,000 bronchoscopic procedures are performed each year in the United States. However, there is lack of information on long-term performance of devices used in these procedures; therefore FDA is limited in its ability to efficiently monitor/evaluate adverse events (AEs) associated with devices used for the treatment or diagnosis of respiratory conditions. Researchers and clinicians in the American College of Chest Physicians (ACCP) have developed two registries: (1) the Bronchoscopy Interventional Registry; and (2) the Bronchoscopy Diagnostic Registry. The main goal of the registries is to collect standardized multicenter 30-day safety for various bronchoscopic interventional and diagnostic procedures. The registries were launched in 2008 and 10 US clinical sites participated. Data has been entered into the registry since mid-February 2009. The Bronchoscopy Interventional Registry collects the following information: (1) General patient and Procedure Information, (2) Indications for Interventional Procedures (malignant or non-malignant diseases); and (3) Quality of Life Indicators/Co morbidities/ mortality/Medication Use/Lifestyle assessment at pre-procedure, periprocedure or 30 days post-procedure. The Bronchoscopy Diagnostic Registry collects information for bronchoscopic procedures such as BAL, Transbronchial Biopsy, Cytology Brushing, Wash, and Transbronchial Needle Aspiration (TBNA). Indications for procedure, periprocedural morbidity information (e.g., bleeding, pneumothorax, and airway injury), and diagnostic outcome will be collected. These registries can grow as needed, as new techniques are developed and new questions are raised. The registries will be enhanced to include longer term efficacy and outcomes data. A nationwide registry that captures AEs associated with the device use will augment FDA’s knowledge of safety and effectiveness when the devices are under general conditions of use postmarket. In addition, the registry could be used as a tool for standardized reporting of multicenter studies of safety, efficacy, resource utilization, patterns of practice, and may provide an alterative to de novo post-approval studies. Finally, the data collected in registries would provide the agency opportunities to conduct observational studies (prospective studies or retrospective studies) to better address device safety and effectiveness in the real-world. Tasks: Contractor shall: 1. Use the data from the registries to prospectively monitor the safety of approved bronchoscopic procedures or devices for the treatment or diagnosis of various respiratory conditions including asthma, emphysema, and lung cancer. Specifically, but not limited to the following: a.To analyze AEs and other outcomes associated with bronchoscopic procedures and/or valve/stent placement and deployment. b.To estimate device removal rate by region/clinical site and by device type, to estimate rate of technical success, and to specify reasons for removal c.To analyze treatment patterns and efficacy among subgroups of lung cancer patients, (i.e. primary lung cancer vs. metastatic lung cancer vs. benign disease) Deliverables: To assess what outcomes are optimal for surveillance (in terms of sensitivity, specificity, etc.) by device type EVALUATION AND AWARD: Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor "Meeting or Exceeding the Requirement," and 2) Price—Includes base price and two (2) option years. Technical Capability is significantly more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. All responsible sources that can provide and meet the above requirements, shall submit written quotation by the response date. QUESTIONS DUE: All questions must be received by email to: karen.petty@fda.hhs.gov, no later than 4:30pm, EST on or before September 1, 2009. QUOTATIONS DUE: All quotations must be received by email to: karen.petty@fda.hhs.gov, no later than 1:30pm, EST on or before September 4, 2009. Telephone calls will not be accepted. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1232/listing.html)
 

Place of Performance

Address: 10903 New Hampshire Avenue, Silver Spring, Maryland, 20903, United States

Zip Code: 20903
 

Record

SN01931479-W 20090830/090829002630-fd68885552b2e7e496c4299ba0303847 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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