SOURCES SOUGHT
R -- Scientific Researcher
- Notice Date
- 8/19/2009
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- 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-09-1061232-SS
- 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
- Total Small Business
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small business (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses. The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to obtain a Scientific Researcher. Background The safety of breast implants remains a major concern because results from epidemiologic studies conducted to evaluate the possible association of breast implants with cancer of the breast and other anatomical sites as well as other systemic conditions have not been consistent or conclusive. FDA’s tools for postmarket surveillance of breast implants include not only requiring manufacturers to conduct post-approval studies of the FDA approved saline and silicone breast implants and breast implant related adverse event surveillance, but also the evaluation of data on postmarket device safety and effectiveness obtained from other sources. These other sources may include published and non-published research findings that help to characterize the postmarket experience with and safety of the implants. Primary lymphomas of the breast are very rare, occurring in 0.5% to 1.5% of breast malignancies with about 900 cases reported annually in the United States. Most are of the less virulent B-cell non-Hodgkin’s type; the more aggressive T-cell type is found in fewer than 5% of these malignancies. Case reports of non-Hodgkin’s lymphomas (NHL) in women with breast implants and analytic studies using data from population-based tumor registries have raised questions about a possible association between exposure to breast implants and the subsequent development of breast lymphomas. However, epidemiologic studies that have evaluated the relationship between breast implants and NHL have not provided conclusive evidence for an association between breast implants and NHL. Many of the epidemiologic studies that evaluated this potential association had methodological flaws that limited the interpretation of the study results. The recent report by DeJong and colleagues of a case-control study conducted in the Netherlands suggested an association between breast implants and anaplastic large T-cell lymphomas. Although FDA drew no conclusions regarding the risk of developing lymphoma in women with breast implants based on the Dutch study findings, the study findings stimulated the interest of medical device epidemiologists and other scientists at FDA in evaluating the possible relationship of breast implants in the etiology of breast lymphoma. Researchers have conducted an extensive search of the literature to identify cases of breast lymphoma associated with breast implants and have used word of mouth contacts to locate as many such reports as possible. They have also collected and evaluated as much data as available on these cases. When clinical course, brand and style of implant were not present in the report of a case, researchers contacted the author of each article reporting a case or treating physician in an attempt to obtain detailed clinical data from medical records to form a comprehensive clinical picture of the cases identified. So far, investigators have identified 34 cases, at least 6 of which were previously unreported. All the tumors were anaplastic large T-cell lymphomas. Researchers have identified the brand and style of 23 of the breast implants used by the identified cases. The objective of this contract is to collaborate with investigators and support the continuation and expansion of the study to evaluate the relationship between breast implants and lymphoma of the breast. The study findings are expected to comprehensively characterize breast lymphomas associated with breast implant use in as many patients as possible, by including linkage of medical history and other clinical data, pathology, hematology-oncology data a particle analysis to study wear particles from implants. This research should provide insight into etiologic pathways, mechanisms, risk assessment and these patient’s unique response to what are otherwise benign particles. The American Society of Plastic Surgeon reports that approximately 307,200 surgical procedures for breast augmentation and close to 79,500 for breast reconstruction were performed in the United States in 2008. In view of the large number of women who avail themselves of breast implants, and the potential health consequences if an etiologic relationship exists between breast implant and NHL, more comprehensive evaluation of NHL that are suspected to be induced by breast implant would provide valuable information to patients and their surgeons. Contractor shall perform the following: Tasks: 1.Submit a complete study protocol. Epidemiology 2.Complete identification of additional cases of breast lymphoma associated with breast implants by reviewing case reports, case series, and epidemiologic studies; by using word of mouth contacts; and by reviewing population-based cancer registry T-cell lymphoma cases. 3.Complete collection of additional data available (e.g., pathology reports, medical history and other clinical data) on the 34 existing cases of anaplastic Large T-cell lymphomas of the breast identified and any other cases identified in task 1 above. Also identify and eliminate duplicates (data originating from the same case encountered from more than one different source) among existing case reports. 4.Complete a comprehensive review of case reports, case series and the epidemiologic studies that evaluate or address the possible association between breast implants and non-Hodgkin’s lymphomas and submit a draft manuscript suitable for publication that summarizes the literature review. 5.Obtain data from breast implant manufacturers needed to estimate the number of patients who have received breast implants by type of implant as specifically as possible to provide a denominator for the statistical analysis of risk. 6.Complete and submit a final manuscript suitable for publication that summarizes the literature and study results that incorporates revisions recommended by FDA. Pathology 7.Study Pathologist team completes validation of the histopathological diagnosis of all identified cases of breast implant associated breast lymphomas. a.For pathology evaluation, complete acquisition of the paraffin blocks, hematoxylin and eosin stained section, cytological preparation, immunohistochemical stained sections, molecular genetic studies, an pathology reports on all cases of anaplastic large cell lymphoma (ALCL) arising in association with breast implants. b.Complete immuno-histochemical analyses on recuts of the blocks for those cases lacking critical immuno-staining findings. Complete immunoglobulin and T cell receptor gene rearrangement analyses if results of these studies are not available. These analyses will include but not be limited to immunoglobulin heavy chain (IgH), T cell receptor β chain, and T cell receptor δ chain gene rearrangements. Hemato-oncology The following tasks will be performed as part of the studies to determine the genetic lesions associated with ALCL: 8.Complete analysis of the activation status of Notch pathway which is most frequent cause of T-cell lymphoma. Examine expression of CCR7, CNTFR, IL22, IL21 and regulation of Notch pathway. 9.Complete comparative genomic hybridization (CGH) on as many cases as the quality of material permits. 10.Complete gene expression analysis on the samples and compare when possible to breast implant unrelated anaplastic lymphoma kinase (Alk) negative ALCL. Complete validation of markers that distinguish breast implant related and unrelated lymphoma. 11.Continue and report progress of development of the recently established cell line for continued analysis. Contractors shall satisfy the following requirements. Provide a detailed description of your company’s (including its teammates, if applicable) experience and demonstrated abilities to deliver each and every one (address each separately) of the following requirements: A fixed price contract is anticipated. This is a new requirement. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents’ capacity and capability to perform the specific work as required. Responses to this notice shall be limited to [15] pages, and must include: 1.Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2.Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3.Business size for NAICS _______ (size standard $ or number of employees) and status, if qualified as an 8 (a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4.DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5.Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6.If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm’s status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, shall also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted shall be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA, may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is for Government market research only, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. RESPONSES DUE: All capability statements must be received by email to: karen.petty@fda.hhs.gov, on or before August 25, 2009 no later than 4:30pm, EST. Telephone calls will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1061232-SS/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Avenue, Silver Spring, Maryland, 20903, United States
- Zip Code: 20903
- Zip Code: 20903
- Record
- SN01917251-W 20090821/090819235747-7073606b5218e43a9e5f21dd58198d4c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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