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FBO DAILY ISSUE OF SEPTEMBER 03, 2004 FBO #1012
SOLICITATION NOTICE

R -- PROFESSIONAL SERVICES TO SPONSOR A WORKSHOP ON METHODS FOR ROUTINE DOCUMENTATION OF MEDICAL DEVICE USE

Notice Date

9/1/2004
 

Notice Type

Solicitation Notice
 

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, MD, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

27291904
 

Response Due

9/8/2004
 

Archive Date

9/23/2004
 

Point of Contact

Sharon Savage, Management Analyst, Phone 301-827-7160, Fax 301-827-7106, - Susan Pearlman, Contract Specialist, Phone (301) 827-7046, Fax (301) 827-7101,
 

E-Mail Address

sharon.savage@fda.hhs.gov, spearlma@oc.fda.gov
 

Description

This is a combined synopsis/solicitation for commercial items or services IAW with the format in FAR Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This solicitation is issued as a Request for Quote (RFQ) No. 27291904. The solicitation clauses and provisions are those in effect through Federal Acquisition Circular 97-27. The Standard Industrial Classification System (NAICS) Code is 541990. The FDA intends to issue a purchase order on a sole source basis to The Food and Drug Law Institute, 1000 Vermont Avenue, NW, Suite 2001, Washington, DC 20005 for a Food, Drug and Law Institute (FDLI) sponsored workshop on Methods for Routine Documentation of Medical Device Use. Background: CDRH?s mission to fully monitor the safety of medical devices would be more feasible once device model information is collected and its use is routinely documented. Good documentation of both device use and problems are necessary for scientifically investigating the safety of devices. For patient safety reporting of adverse device events, it is essential that a device be uniquely identified. For improving patient safety, reports of adverse device events may be lead to analysis of the use of all or a sample of a particular device to obtain information about the likelihood of such events and may lead to patient follow-up by providers of their patients using such devices. In these cases, having unique device identification in the patients? medical records, and pointers to a database for information about that specific device is necessary. One way to examine and facilitate potential solutions to the issue of unique identification is to bring experts from the relevant fields together to discuss the problem and recommend actions. The purpose of this project is to work with representatives from medical device industry representatives, major bar-coding systems, FCC representatives, the radio frequency identification industry, National Library of Medicine, other Federal agencies and academia. We want to obtain their feedback regarding the development of a public-private partnership with the idea of adopting a unique identification system for medical devices. The end goal might then be the collection of this information via the FDA web based electronic system agency wide registration and listing system (FURLS) and the drafting of the regulations that would be required in order to collect this information. The best vehicle for this work is through targeted workshops with these organizations. The contractor will need to perform the Scope of Work, which is to include: Requesting professional services to host and facilitate two workshops to obtain feedback on the development of a unique identification system for medical devices. These workshops would be held with CDRH and invited members of industry, government and academia to discuss this issue. These workshops will be held at the FDLI office located in Washington, D.C. 1) Participants of the workshop will be given preliminary documentation to review prior to the meeting. The information will describe where we are at with a unique identification system; 2) Attendees will participate in an information exchange with CDRH so that we can gain a better understanding of the impact and process of the proposed development of a public-private partnership with the goal of adopting a unique identification system for medical devices; 3) Two workshops will be held on the development of a public-private partnership with the goal of adopting a unique identification system for medical devices. The length of each workshop will be one and one-half days with dates to be determined. Tasks for each workshop: a) Determine the list of non-FDA attendees based on their knowledge and experience with the medical device industry and academia. CDRH will provide a list of criteria for which they will use to nominate these outside individuals and organizations; b) Prepare and mail invitations or email invitations along with any written materials provided by FDA; c) Facilitate each meeting/workshop held at FDLI?s Office/location; d) Record the information exchange at each workshop. This will include documenting of decisions and findings. These reports will be provided to CDRH within two weeks after a meeting is held. Contractor shall provide an electronic version (pdf) and hard copy of these minutes to each attendee. Contractor shall provide CDRH with an additional copy in Microsoft word format. The contractor shall have a good grasp on how medical devices are manufactured and used. They must have an excellent understanding of the type of participants that need to be involved and have already established working relationships with many of the groups that the Center for Devices and Radiological Health (CDRH) will need to use for this workshop. Payment Schedule: Payment shall be made upon completion of all tasks and deliverables associated with a single workshop upon submission of an invoice. All payments are subject to the approval of the Project Officer. The FDA intends to make an award immediately following this notice. The anticipated period of performance will be approximately September 27, 2004 through September 30, 2005. The following FAR clauses shall apply to the solicitation: 52.212-1 Instructions to Offerors-Commercial; 52.212-2 Evaluation-Commercial Items; 52.212-3 Offeror Representations and Certifications; 52.214-4 Contract Terms and Conditions-Commercial Items; and 52.232-33 Electronic Funds Transfers. All responsible sources that can provide and meet the above requirements shall submit written quotations by the due date referenced above. All questions should be submitted in writing via email to sharon.savage@fda.hhs.gov or fax to (301) 827-7106. FAR provisions can be found at the following website: http://www.arnet.gov.
 

Place of Performance

Address: 1000 Vermont Avenue, NW, Suite 2001, Washington, DC

Zip Code: 20005

Country: US
 

Record

SN00662963-W 20040903/040901211804 (fbodaily.com)
 

Source

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

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