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FBO DAILY ISSUE OF AUGUST 08, 2010 FBO #3179
SOLICITATION NOTICE

A -- NOTICE OF INTENT - Evaluation of Safety and Effectiveness of Mesh Implantation in Surgical Interventions for the Treatment of Pelvic Floor Disorders

Notice Date

8/6/2010
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

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-SOL-1076175
 

Archive Date

9/4/2010
 

Point of Contact

kara stith, Phone: 3018277045
 

E-Mail Address

kara.stith@fda.hhs.gov
(kara.stith@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

The U.S. Food and Drug Administration (FDA) intends to award, using Simplified Acquisition Procedures, in accordance with FAR Part 13, a sole source award to The Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery of the Kaiser Permanente Southern Region, under authority of FAR 6.302-1 41 U.SC. 253 ( C )( 1 ) which states that only one responsible source and no other supplies or services will satisfy agency requirements. The Government anticipates the issuance of Award within (5) days after the response date of this notice. It is anticipated that the period of performance will be September 1, 2010 through August 31, 2011. This group has access to the system-wide deployment of a comprehensive electronic medical record (HealthConnect® - Epic Systems Corp, Verona WI) that can be modified to collect information critical for this study. KPSC uses HealthConnect® and it has been in place for over 2 years. The system can be modified for prospective data collection by the addition of a module that specifically collects information on the data needed for this study. The urogynecologists at KPSC are already using HealthConnect, to evaluate and record observations on their patients. They are familiar with the use of additional modules for specific purposes, minimizing the need for extensive training. The HealthConnect system has already been tested and validated and has a specific methodology for addition of modules for specific research purposes. The module can be designed and pretested on the system before launch into regular practice. KPSC computer programmers have specialized skills in module development using the HealthConnect system. This will allow ease in development and assurance of confidentiality of both the system and health care information. This will allow pilot testing within the live system. FDA previously used KPSC for the Phase I of the Mesh study and has collaborated with KPSC urogynecologists during Phase I. KPSC has used the Health Connect® for two years. The urogynecologists at KPSC are already using HealthConnect to evaluate and record observations on their patients. They are familiar with the use of additional modules for specific purposes, minimizing the need for extensive training; decreasing the cost for Phase II of the study. It would not be in the best interest for the Government to have another electronic system redeveloped by another contractor, not only in terms of money, but also in terms of the time and efforts that have already been put into the development of HealthConnect® and FDA's evaluation of the safety and effectiveness of surgical mesh. All responsible sources may submit a response by the due date of this posting to Kara.Stith@fda..hhs.gov and all questions regarding the post should be sent to the same e-mail address. Responses must be received within five days from the published date of this notice. All responses must be sent electronically, no faxes will be accepted.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1076175/listing.html)
 

Place of Performance

Address: 10903 New Hampshire Avenue, Building 66, Silver Spring MD 20993, United States

Zip Code: 20993
 

Record

SN02232300-W 20100808/100806235714-0c301a181a4150c0b2823d3c0ae3eaf6 (fbodaily.com)
 

Source

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

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