SOURCES SOUGHT
B -- Evaluation and Administration Claims Data to Study Performance of Total and Partial Hip Replacement Differentiated by Bearing Surface for FDA
- Notice Date
- 8/20/2010
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting 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
- 1077939
- Archive Date
- 9/9/2010
- Point of Contact
- Mary Rose A. Nicol, Phone: 3018277183
- E-Mail Address
-
MaryRose.Nicol@fda.hhs.gov
(MaryRose.Nicol@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought/Request for Information (RFI) for the purpose of conducting Market Research that will be used to formulate an acquisition strategy to procure Evaluation of Administrative Claims Data to Study Performance of Total and Partial Hip Replacements Differentiaed by Bearing Surface. Specifically, this notice seeks to ascertain the availability and capability of qualified and small business sources that include HUBZone, service-disabled, veteran-owned, women-owned, 8(a), or small disadvantaged businesses. The applicable North American Industry Classification System (NAICS) codes is 541690. This notice is for planning purposes only and is not a notice of solicitation issuance. Nor does this notice constitute a commitment, implied or otherwise, that a procurement action will be issued in the future. The Government will not reimburse Contractors for any effort resulting from their response to this notice. Statement of Work Evaluation of Administrative Claims Data to Study Performance of Total and Partial Hip Replacements Differentiated by Bearing Surface 1. Purpose The goal of the contract is to establish a cohort of patients within the Centers for Medicare and Medicaid Services (CMS) Administrative Claims Data who have received a total or partial hip replacement and to evaluate performance associated with each bearing surface. 2. Background Administrative medical claims data have gained an increased importance in the postmarket surveillance of medical devices because they contain rich information that can augment other postmarket tools used to study performance of medical devices in the real- world setting. 3. Statement of Work A) Objectives: The objective of this study is to utilize CMS data for evaluation of performance of different bearing surfaces for use in total and partial hip replacements as part of an ongoing evidence synthesis for all hip replacements. The Agency is seeking to work collaboratively with an outside entity in establishment of an algorithm to define a cohort of patients within the data who have received hip replacements as well as to create protocols for collection of short-term and long-term safety and effectiveness endpoints from the data. The Agency and contractor will work together to evaluate the cohort and endpoint data to determine rates of surgical revision and other adverse events. B) Scope of Work: 1. Identification and description of cohort of people within CMS data with a hip replacement. This should include number of patients with new hip replacement surgery by type of bearing surface using ICD-9-CM, CPT, and HCPCS codes over a specified timeframe. Cohort description should include demographic characteristics, surgical procedure information, changes in number and type of hip replacement surgery over calendar time, and hospital location and size. 2. Development of a strategy to identify and describe revisions and other adverse events of interest. Description of each type of adverse event should include demographic characteristics of patients experiencing the event, changes in number of events over calendar time, and length of time between implant and event. 3. Estimation of overall incidence rates of revision and other adverse event rates. Assess both a single, aggregate adverse event rate and changing rates across duration of implantation for each type of adverse event. Estimate both unadjusted rates and rates stratified by age, gender, and rheumatoid arthritis status. 4. Estimation of incidence rates of revision and other adverse events for each bearing surface. Assess both an aggregate adverse event rate and changing rates across duration of implantation for each type of adverse event. Estimate both unadjusted rates and rates stratified by age, gender, and rheumatoid arthritis status. 5. Comparison of the incidence rates and proportions of each adverse event related different bearing surfaces. Compare differences and ratios for both aggregate and changing rates for each type of adverse event. Estimate both unadjusted effect measures and those adjusted for known risk factors. Utilize statistical methods which account for characteristics of all variables: device implant exposure, adverse events, risk factors, confounders, modifiers, and instruments. 6. Comparison of short-term and long-term effectiveness and safety related to different bearing surfaces. Compare differences and ratios for both aggregate and changing rates for the overall number of revisions and other adverse events. Include analyses that account for only the first event experienced by each patient and for all events experienced by patients within a specified timeframe since implant. Estimate both unadjusted effect measures and those adjusted for known risk factors (as identified in the literature review which is underway). Utilize statistical methods which account for characteristics of all variables: device implant exposure, adverse events, risk factors, confounders, modifiers, and instruments. 7. Publication of findings in the peer reviewed literature. 4. Period of Performance The contract performance period will be 12 months from the date of contract execution 5. Payment Schedule Quarterly invoices will be submitted for completed work detailing work hours spend and services completed during the past month. Upon approval of each quarterly invoice, payment should be provided for services completed from 30 days of approved submission. 6. Deliverables The contractor shall: 1. Brief bi-weekly (every other week) discussions regarding progress. 2. Semi-annual report describing the work and the results. 3. Final report summarizing the work completed. Request for Information (RFI) In order that the FDA may determine vendor qualifications, please submit your company's capability statement including information that addresses the following: 1. What is your company name, mailing address, e-mail address, telephone and fax number, web address (if available)? Please provide a name, e-mail address, and telephone number of a point of contact that has authority and knowledge to clarify responses with Government representatives. 2. What is your company's core business capability, experience, and/or ability as it relates to the Statement of Work. 3. What is your company's experience as it relates to NAICS Code 541690 4. What is your company's business size for NAICS Codes 541690 srandard? 5. Is your company qualified as an 8(a) firm (must be certified by SBA), small disadvantaged business (must be certified by SBA), woman-owned business, HUBZone firm (must be certified by SBA), service-disabled veteran-owned business (must be listed in VETBiz vendor information pages)? 6. Is your company registered in the Contractor Central Registry (CCR)? Submission Deadline Interested offerors shall their capability statement not exceeding (10 pages in length, excluding standard brochures. Responses to this notice shall be electronically forwarded to Ms. London Johnson, Contracting Officer at: maryrose.nicol@fda.hhs.gov, Sr. Contract Specialist not later than Friday, August 25, 2:00 Noon, Eastern Standard Time (EST). Contracting Office Address Attn: Mary Rose A. Nicol 5630 Fishers Lane, Room 2089 Rockville, MD 20857
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1077939/listing.html)
- Place of Performance
- Address: Rockville, Maryland, 20832, United States
- Zip Code: 20832
- Zip Code: 20832
- Record
- SN02249672-W 20100822/100820235939-e8e5266037897f1c82d5786d1e83c43d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |