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FBO DAILY ISSUE OF AUGUST 30, 2009 FBO #2836
SOLICITATION NOTICE

A -- Scientific Researcher

Notice Date

8/28/2009
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

611310 — Colleges, Universities, and Professional Schools
 

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-09-1061236
 

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

N/A
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541511, is to notify contractors that the Food and Drug Administration (FDA) is seeking competition of this requirement in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. Under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-35. This synopsis is designated for Full and Open competition for a firm fixed-price purchase order. Any small business firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services, which will be considered if received by the second (2nd) calendar day following the appearance of this announcement. Prospective offerors are responsible for monitoring the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking 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 reports 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, they 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, Researchers 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 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. TASK: 1. Submit a complete study protocol. Conduct study to evaluate the association between use of breast implants and subsequent Non-Hodgkin Lymphoma of the Breast, including the following: 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. DeliverableDate Due Study protocolOctober 15, 2009 Quarterly report December 31, 2009 Quarterly report March 31, 2010 Draft 1 study report/manuscriptApril 31, 2010 Quarterly reports June 31, 2010 Final study report/manuscriptJuly 31, 2010 Quarterly reportAugust 31, 2010 EVALUATION AND AWARD: Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor "Meeting or Exceeding the Requirement," and 2) Price. Technical Capability is significantly more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. All responsible sources that can provide and meet the above requirements, shall submit written quotation by the response date. QUESTIONS DUE: All questions must be received by email to: karen.petty@fda.hhs.gov, no later than 4:30pm, EST on or before August 31, 2009. QUOTATIONS DUE: All quotations must be received by email to: karen.petty@fda.hhs.gov, no later than 4:30pm, EST on or before September 3, 2009. Telephone calls will not be accepted. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1061236/listing.html)
 

Place of Performance

Address: Contractors location and 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, United States

Zip Code: 20903
 

Record

SN01932372-W 20090830/090829005914-96d1b74caa9cae47f6abd1769c294ac8 (fbodaily.com)
 

Source

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

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