SOURCES SOUGHT
B -- Natural History of Head and Neck Cancer
- Notice Date
- 8/26/2013
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 1050, Frederick, Maryland, 21702, United States
- ZIP Code
- 21702
- Solicitation Number
- SS-NCI-130132-RR
- Point of Contact
- Reyes Rodriguez, Phone: 3014353796, Contracting Officer, Phone: 240-276-5419
- E-Mail Address
-
reyes.rodriguez@nih.gov, ninans@mail.nih.gov
(reyes.rodriguez@nih.gov, ninans@mail.nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The purpose of this Sources Sought Notice is to identify qualified concerns including 8(a), HUBZone or Service-Disabled Veteran-owned businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned North American Industry Classification System (NAICS) code 541990 with a size standard of $14.0M is being considered. As a result of this Sources Sought Notice, the NCI may issue a Request for Quotation (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Sources Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Although it has long been recognized that oral leukoplakias, the most common head and neck cancer precursors, can progress to invasive cancer, there is wide variability in rates of malignant transformation in the literature (0.1% to 36.4%). Very few studies have assessed the natural history of leukoplakias (or other precursors) in large, population-based studies with complete outcome ascertainment. Consequently, the absolute risks and the time course of progression of precursors to invasive cancer are currently unclear. Additionally, the impact of the grade of dysplasia on malignant transformation and the efficacy of surgical treatments in decreasing malignant transformation are currently unclear. To address these questions, researchers at the National Cancer Institute will conduct a retrospective cohort study to characterize the natural history of head and neck cancer precursors. Individuals with precursors (leukoplakia, erythroplakia, and oral lichen planus) and incident invasive head and neck cancers (oral cavity, oropharynx, other pharynx, and larynx) will be identified through participant medical records. Head and neck cancer incidence will be compared between individuals with precursor lesions vs. the overall contractor population through standardized incidence ratios. Within the cohort of individuals with precursors, malignant transformation rates will be compared by demographic, pathological, clinical, and behavioral characteristics. Additionally, among individuals with precursor lesions, 2-year, 5-year, and 10-year absolute risks of head and neck cancer will be estimated. To be deemed capable of providing the current need for the services the offeror must submit a written capability statement. The contractor shall perform the following tasks: Task 1: Study start-up and submission for contractor IRB review. Task 2: Provide a statistical analysis plan for the study, including inclusion/exclusion criteria and variables to be considered for analyses. Task 3: Estimate the counts and prevalence rates of head and neck cancer precursor lesions (leukoplakia or erythroplakia, ICD codes= 528.6 or 528.79; oral lichen planus, ICD codes= 697) in the entire contractor population during 1996-2010, overall and by individual calendar year. Estimate incidence rates of head and neck cancers (ICD-O-3 topography sites: C000-C148 and C320-C329) in the entire contractor population and among individuals with head and neck cancer precursor lesions (separately for leukoplakia/erythroplakia and oral lichen planus) during 1996-2012. Compare incidence of head and neck cancers among individuals with precursor lesions versus the overall contractor population using standardized incidence ratios (standardized for age in 5-year groups, gender, and calendar year). Task 4: For individuals with precursor lesions who received a biopsy, the pathology report will be mined using text phrases (e.g. low-grade or mild dysplasia, moderate dysplasia, high-grade or severe dysplasia, dysplasia, hyperkeratosis, no evidence of dysplasia) to retrieve the pathology result. For a random subset of patients 100 patients, retrieve the pathology reports and conduct manual reviews. For this random subset, compare results of text mining with results of manual review. Task 5: Among individuals with precursor lesions, estimate predictors of malignant transformation using Poisson regression or Cox regression models. These analyses will specifically focus on the following variables: presence and grade of dysplasia (classified as no dysplasia, low-grade dysplasia, and high-grade dysplasia), age, gender, anatomic site of precursor (where available), socioeconomic status, smoking, alcohol abuse, treatment of precursors, and HIV status. Estimate 2-year, 5-year, and 10-year absolute risks of head and neck cancers (by anatomic site) among individuals with precursor lesions. PERIOD OF PERFORMANCE: The period of performance shall be for 12 months from date of award. How to Submit a Response: 1. Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed 10 single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the ability to perform the requirements of the notice described above. All proprietary information should be marked as such. Responses should include a minimum of a one page resume of the individuals meeting the requirements, and up to two pages demonstrating experience over the past two years meeting the requirements of this notice. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferable placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. 2. Due Date: Capability statements are due no later than 12:00 p.m. EST on August 30, 2013. 3. Delivery Point: All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. All questions must be in writing and can be faxed to (240) 276-5401 or emailed to Reyes Rodriguez at reyes.rodriguez@nih.gov. A determination by the Government not to compete this requirement 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 number SS-NCI-130132-RR on all correspondence. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, an RFQ may be published in eBuy. However, responses to this notice will not be considered adequate responses to a solicitation(s). Point of Contact: Inquiries concerning this Notice may be direct to: Reyes Rodriguez 9609 Medical Center Dr, Room 1E640 Bethesda, MD 20892-9705 Reyes.rodriguez@nih.gov Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/SS-NCI-130132-RR/listing.html)
- Place of Performance
- Address: Contractor's site, United States
- Record
- SN03162856-W 20130828/130826235826-125e4a9d93c35c7ba29d4204141f2471 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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