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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 12, 2014 FBO #4463
SOLICITATION NOTICE

B -- Risks of Adverse Events in Breast Cancer Patients Treated with Adjuvant Chemotherapy

Notice Date

2/10/2014
 

Notice Type

Presolicitation
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
 

ZIP Code

20852
 

Solicitation Number

N02CP46019-83
 

Archive Date

3/12/2014
 

Point of Contact

Gwennifer K. Epps, Phone: 2402765445, Terry Galloway, Phone: 240-276-5384
 

E-Mail Address

eppsg@mail.nih.gov, gallowaytl@mail.nih.gov
(eppsg@mail.nih.gov, gallowaytl@mail.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

The National Cancer Institute (NCI), Center for Cancer Research, Epidemiology and Genomics Research Program, Clinical and Translational Epidemiology Branch plans to procure on a sole source basis a service contract with UC Davis School of Medicine, 2103 Stockton Blvd., Suite 2226, Sacramento, CA 95817. This process will be processed in accordance with simplified acquisitions procedures as stated in FAR Part 13 13.106-1(b)(1) and is exempt for the requirements of FAR Part 6. The North American Industry Classification System code is 541990 - All other Professional, Scientific and Technical Services and the business size standard is 14 million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. It has been determined there are no opportunities to acquire green products or services for this procurement. The Division of Cancer Control and Population Sciences (DCCPS) aims to reduce the risk, incidence, and deaths from cancer as well as enhance the quality of life for cancer survivors. The Division conducts and supports an integrated program of the highest quality genetic, epidemiologic, behavioral, social, and surveillance cancer research. Breast cancer mortality rates have declined over the past 20 years and although much of the improvements in mortality have been attributed to early diagnosis and adjuvant treatment of early stage breast cancer, these treatment regimens are associated with substantial short-term toxicity and risk of long-term adverse effects, such as secondary malignancies, neuropathy, cognitive impairment, and cardiotoxicity. Until recently, women with breast cancer have received adjuvant chemotherapy based on clinical recurrence risk classification using qualitative tumor characteristics, such as size, type and grade, receptor status, and histology, although increasingly gene expression profiling is being used to direct adjuvant therapy choices. Nevertheless, many women will still receive adjuvant chemotherapy that will have only a modest effect on disease-free and overall survival. These patients may receive limited benefit from chemotherapy and an improved understanding of these long-term adverse risks of treatment could help to inform clinical decision-making about adjuvant chemotherapy (i.e., women with low risk of recurrence could avoid potential toxicity and morbidity of adjuvant chemotherapy). Even when use of chemotherapy is indicated, patients are seldom informed about the specific risks for long-term and late effects, which could potentially inform treatment decision-making. Yet, no systematic reviews or risk appraisal have addressed this question. Long-term and late adverse effects (e.g., leukemia, congestive heart failure, neuropathy, cognitive dysfunction, infertility) of chemotherapy are widely acknowledged, but their risks are not explicitly considered in currently available risk prediction models. This limits the ability of clinicians and patients to weigh the potential harms versus benefits of adjuvant chemotherapy in treatment decision making. Randomized trials of adjuvant chemotherapy have predominantly focused on evaluating the reduction in cancer recurrence and on treatment-associated short-term adverse effects. Less attention has been given to long-term adverse effects of these cytotoxic drugs, which may have significant negative impacts on health and QOL for breast cancer survivors long after their treatment ends. The aim of this requirement is to estimate the rates of long-term adverse effects of commonly used adjuvant chemotherapy regimens for breast cancer by conducting a systematic review of the literature and by analyzing data collected from a clinical trial of over 5,000 patients with node-positive breast cancer. This project is critical not only to define what the NCI currently knows about treatment harms, but perhaps more importantly, to identify gaps in existing knowledge that will guide future research. This project will help inform the NCI in the planning and prioritizing future research initiatives developing patient-level risk prediction model to assist patients and clinicians in making informed decisions about the benefits and risks of adjuvant chemotherapy for early stage breast cancer. Contractor Requirements: The Contractor shall provide adequate equipment, supplies, facilities, and scientific materials necessary for carrying out the requirements of this project. The Contractor shall work on several key tasks, including but not limited to the following: 1. Evaluate the literature on long-term adverse events following treatment with adjuvant chemotherapy in breast cancer patients draft a manuscript reporting the findings. a. Specifically, information from published literature on chemotherapy agents commonly used in the U.S. for breast cancer adjuvant therapy (i.e., anthracyclines, cyclophosphamide, taxanes, and trastuzumab) and the risk of chemotherapy-related adverse events (i.e., cardiac toxicity, ovarian failure, secondary malignancies, neurotoxicity, and cognitive dysfunction) will be systematically reviewed and described. The completed manuscript shall be submitted to a peer-reviewed journal. 2. Conduct secondary analyses using data from the NSABP B-30 trial to estimate the frequency and impact of adverse events resulting from adjuvant chemotherapy and draft a manuscript reporting the findings. a. Data from the NSABP B-30 trial, which enrolled over 5,000 node-positive breast cancer patients who were randomized to three different treatment arms containing an anthracycline and a taxane, shall be analyzed by the Contractor and shall supplement finding from the systematic review. Payment shall be made after acceptance by the Government of each deliverable. Period of performance: 12 months from the date of award. This project requires expertise in epidemiology, evidence-based medicine, systematic reviews, meta-analysis, breast oncology treatment, survivorship and quality of life. The UC Davis Center for Healthcare Policy and Research currently employs a research team of scientists who are uniquely qualified to perform this work and bring a unique combination of experience with systematic reviews and rigorous training in epidemiology, evidence-based medicine, benefit-risk prediction modeling for patient decision-making and breast cancer treatment and survivorship. This research team brings key access to data from the NSABP B-30 trial, and with expertise in the Bayesian statistical models, has the ability to address the key research questions that NCI requires with highest level of content knowledge, familiarity with and access to the NSABP B-30 data, methodological rigor and advanced statistical techniques that could not replicated elsewhere. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on, February 25, 2013. No electronic capability statements will be accepted (i.e. email or fax), an original and one copy must be sent to the NCI Office of Acquisitions at the address stated above. All questions must be in writing and can be faxed (240) 276-5401 or emailed to Gwennifer Epps, Contracting Officer at ge50d@nih.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA), through sam.gov. No collect calls will be accepted. Please reference solicitation number N02CP46019-83 on all correspondence.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CP46019-83/listing.html)
 

Place of Performance

Address: UC Davis School of Medicine, 2103 Stockton Blvd., Suite 2226, Sacramento, California, 95817, United States

Zip Code: 95817
 

Record

SN03284846-W 20140212/140210234148-4b09a0e60cceea48c4f3d52de873b7c8 (fbodaily.com)
 

Source

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

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