SOLICITATION NOTICE
A -- Medical Device Safety Communications Focus Groups
- Notice Date
- 7/12/2006
- Notice Type
- Solicitation Notice
- 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-Req1018369
- Response Due
- 7/26/2006
- Archive Date
- 10/1/2006
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation, a simplified acquisition under FAR part 13 and a total small business set-aside. The Food and Drug Administration (FDA) has a requirement for focus group research to deal with medical devices. In recent years, a number of implantable cardiac defibrillators (ICDs) and pacemakers have been recalled. Recalls of implanted devices prove to be a challenging risk communication issue. FDA would like patients to have the most timely, complete, balanced risk information about their medical devices, both implanted and non-implanted devices, without unduly alarming patients who depend on them. In this study, we will conduct a series of six (6) focus groups with patients with medical devices and caregivers who help in healthcare decision-making for patients who have medical devices. FDA will use the information from these focus groups in order to design appropriate risk communication information for consumers. The objective of the focus group study is to explore consumers' information needs regarding safety information about their medical devices. We will conduct a total of six (6) focus groups with nine (9) participants per group. Two (2) groups will consist of patients who have ICDs and pacemakers and caregivers who help in healthcare decision-making for patients with ICDs and pacemakers, two (2) will consist of patients with implanted devices other than ICDs and pacemakers and caregivers who help in healthcare decision-making for patients with implanted devices other than ICDs and pacemakers, and two (2) groups will consist of patients who use non-implanted devices in their daily lives and caregivers who help in healthcare decision-making for patients with non-implanted devices. The caregivers will not be those who help in the healthcare decision-making for the patients who participate in the group. Each group will discuss their own risk information needs or the needs of those patients they care for. The responses gained through these focus groups will be used to help FDA develop outreach materials for patients. SCOPE OF WORK: No work described in this section is to begin until FDA receives clearance of the project from OMB and FDA's Research in Human Subjects Committee (RIHSC). The Contractor will furnish the necessary personnel, services and facilities to recruit participants and conduct six (6) focus groups. Each group is expected to last 90 minutes. The focus group sessions shall be audio-taped, and the Contractor will provide a written topline report and transcripts within three weeks following the conduct of each focus group. All records containing participants' names must not be transmitted to the FDA and must be destroyed as soon as possible to ensure anonymity of participants. Responsibilities of FDA: Prepare screening tool and moderator's guide; Obtain all necessary RIHSC and OMB clearances. Responsibilities of the Contractor: After consultation with FDA/CDRH, develop and submit to FDA/CDRH, no later than 14 days after the award a written plan and timeline for accomplishing the work; Recruit 12 participants per group in order to obtain 9 participants, to account for no-shows; Report to FDA on status of recruitment; Schedule ICD/pacemaker focus groups to take place in afternoon sessions, with other groups scheduled for evening sessions; Review moderator's guide, and any other accompanying background materials, to prepare for the focus group sessions; Provide focus group facility; Provide taxi services for participants who do not have their own transportation; Provide a waiting room and refreshments for any drivers of participants who do not have their own transportation and do not wish to use taxi service; Conduct six (6) focus groups; Provide refreshments to the focus group participants; Provide incentive payments of $75 to each participant; Audiotape the focus group sessions; and Provide all transcripts, reports and deliverables. REPORTS AND DELIVERABLES: 1. Project report: six paper copies and one electronic copy of a report describing details of all aspects of the project; a. Recruitment and screening procedures, which FDA will provide to the contractor; b. Final number of participants in each group; c. Moderator's guide; d.Preparation and processing of transcripts; e.Topline report analyzing major themes noted by the moderator in the focus groups; 2. Two (2) copies per group of typed transcripts of the focus groups. Performance of this task order shall begin on a date to be negotiated and shall not extend beyond 90 days from the date of the start of the focus groups. Offerors shall submit technical proposals to demonstrate their ability to perform the work. Technical merit will be assessed on the following factors: 40% Documented experience in successful recruitment of consumers of medical devices for focus group participation. Experience overcoming recruitment difficulties to achieve desired number of participants; 20% Documented experience recruiting and screening potential participants for focus groups that concern emotional, high stress, or sensitive issues; 20% Documented experience in moderating focus groups when the consumers are likely to respond very emotionally to high stress or sensitive issues, as well as experience moderating medical topic focus groups with consumers; and 20% Documented availability of a state-of-the-art focus group facility that is accessible for people with disabilities. A separate pricing proposal must be submitted itemizing projected costs required to complete the work. Cost realism will be analyzed to determine the offeror's understanding of the requirement as well as to evaluate the reasonableness of the proposed price. A Time-and-Materials or firm fixed price award is anticipated, with a monthly payment schedule corresponding to the offeror's anticipated monthly costs or cash flow or corresponding to progress achieved, except that not less than 5 percent of the negotiated price shall be withheld pending acceptance of the final report and all raw data. Payment of monthly invoices will depend on acceptance by the Project Officer of the progress reported. This is a best buy acquisition in which technical factors are significantly more important than all other factors including price and past performance. Award will be made using SF1449 as a bilateral purchase order in accordance with FAR Part 13, Simplified Acquisition Procedures; all relevant required clauses will apply. FAR clause 52.212-1 at http://acquisition.gov/comp/far/current/html/52_212_213.html shall be included as well as 52.212-3, Offeror Representations and Certifications?Commercial Items and 52.212-4, Contract Terms and Conditions?Commercial Items. Proposals must be submitted in electronic form to Robert.Julia@fda.hhs.gov. Hardcopy proposals will be accepted at the contracting office address set forth above, marked for Robert Julia, but electronic versions of all documents must be provided unless physically impossible (drawings or designs that cannot be created electronically or scanned). Proposals are due not later than 4:30pm Wednesday July 26, 2006. Questions concerning this acquisition should be submitted by email to Mr. Julia within four days following this announcement; answers will be provided as an amendment to this combined synopsis/solicitation.
- Record
- SN01087140-W 20060714/060712220358 (fbodaily.com)
- Source
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