SOURCES SOUGHT
B -- Create Database for Risk Factors for Progression to Esophageal Adenocarcinoma
- 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-130139-RR
- Point of Contact
- Reyes Rodriguez, Phone: 240-276-5442, Seena Ninan, 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 $14.0 M 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. NCI/DCEG/HREB, is conducting a study in which the three primary objectives are: 1. To describe site-specific cancer incidence and underlying causes of death of a US Barrett's esophagus cohort compared with rates derived from the total population of Kaiser Permanente Northern California. 2. To assess risks of GERD and BMI on progression from Barrett's esophagus to esophageal adenocarcinoma. 3. To assess whether metabolic syndrome is a risk factor for progression from Barrett's esophagus to esophageal adenocarcinoma. The cohort will include individuals diagnosed with Barrett's esophagus at any age. Barrett's esophagus will be defined as having either at least one instance of the Barrett's esophagus-specific ICD-9 code 530.85 or at least one instance ICD-9 code 530.2 and one instance of SNOMED code M73330. NCI will use the first instance of any of these codes as the diagnosis date of Barrett's esophagus and as "time 0" for subsequent time-to-event analyses. For all subjects, the contractor will extract variables from electronic medical and pharmacy records to create a database from data on Barrett's esophagus patients. Contractor Requirements are: 1. The Contractor shall have access to a large study population of at least 3 million adult men and women of multiracial/ethnic background with prospective, sequential, and detailed data on medical history, prescription medications, cancer incidence and mortality. The cancer outcomes shall include date of diagnosis, anatomic subsite, histologic type, and tumor stage and grade at diagnosis. 2. The contractor shall perform the following tasks. a. Obtain approvals from IRB and other institutional officials within 3 months of the award for extracting relevant data from computerized databases and prepare analytic files suitable for epidemiologic research. b. Contractor shall submit recommended covariates from the various databases to the Contracting Officer's Representative (COR) for review and approval to be included in the analytic file within 4 months of the award. Where possible, the covariates shall include those outlined below. c. Contractor shall submit recommended subject eligibility criteria to the (COR) for review and approval within 5 months of the award. d. Prepare the study data files in STATA format and the file description and dictionary in Microsoft Word format. The data files shall be sent within 10 months of the award and will contain no personal identifiers. The list of variables to be extracted is shown below. Each variable with an asterisk will be extracted; however, many times it is available for each individual participant along with the date of the code. Variable(s) will be extracted regardless of the date of Barrett's esophagus diagnosis (i.e., NCI will extract data both before and after this diagnosis date). This will enable flexibility in analysis. Sex Age Date of Birth (MM/YYYY) Race/ethnicity *Barrett's esophagus diagnosis codes (ICD-9 + SNOMED) with dates (MM/DD/YYYY) *Length(s) of Barrett's esophagus segment (cm) with dates (MM/DD/YYYY) *Prague C & M classifications (CxMx) with dates (MM/DD/YYYY) *Specialized intestinal metaplasia (SIM) diagnosed (Y/N) with dates (MM/DD/YYYY) *Cancer diagnoses (ICD-9) *Histologic codes (ICD-O-3) *Dates of cancer diagnoses (MM/DD/YYYY) Date of death Causes of death (ICD-9) Underlying cause of death (ICD-9) *GERD ICD codes with dates (MM/DD/YYYY) ICD-9CM 530.81- esophageal reflux, gastroesophageal reflux (GERD) ICD-9CM 530.11- reflux esophagitisICD-9CM 530.10 - esophagitis, unspecified ICD-9CM 530.12 - acute esophagitis ICD-9CM 787.1- heartburn (excluding dyspepsia or indigestion) *GERD medications, dosage and number of pills, with dates (MM/DD/YYYY) H2RAs (including Amofox Ausran Axid Cimetidine Famotidine Nizatidine Pepcid Ac Pepcidine Ranitidine Tagamet Tazac Zantac) PPIs (including Aciphex Esomeprazole Lansoprazole Losec Nexium Omeprazole Pantoprazole Pariet Prevacid Prilosec Protonix Rabeprazole Somac Zegarid Zoton Protium) *Anthropometric measures with dates (MM/DD/YYYY) Weights (kg) Heights (m) BMIs (kg/m2) *Number and dates (MM/DD/YYYY) of clinical visits as a proxy for comorbidity Total number of clinical visits in the 2 year period prior to the date of BE diagnosis *Obesity: BMI≥30, 278.00 (obesity, NOS), 278.0 (overweight and obesity), 278.1 (localized adiposity), 278.01 (morbid obesity) *Dyslipoproteinmia: 272.0 (Pure hypercholesterolemia), 272.1 (Pure hyperglyceridemia), 272.2 (Mixed hyperlipidemia), 272.4 (Other and unspecified hyperlipidemia), 272.5 (Lipoprotein deficiencies), 272.9 (Unspecified disorder of lipoid metabolism), at least 90 consecutive days supply of a hypercholesterolemia medication (list to be provided by NCI) *Hypertension: 401, 401.0, 401.1, 401.9, 402.0, 402.1, 402.9, 403.0, 403.1, 403.9, 404, 404.0, 404.1, 404.9, at least 90 consecutive days supply of an anti-hypertensive (list to be provided by NCI) *Impaired fasting glucose/diabetes mellitus: Diabetes type II codes: 250.00 (Diabetes mellitus type II without mention of complication), 250.02 (type II uncontrolled), 250.10 (type II with ketoacidosis), 250.12 (type II with ketoacidosis/uncontrolled), 250.20, 250.22, 250.30, 250.32, 250.40, 250.42, 250.50, 250.52, 250.60, 250.62, 250.70, 250.72, 250.80, 250.82, 250.90, 250.92; Abnormal glucose codes: 790.2, 790.21, 790.22, 790.29, at least 90 consecutive days supply of insulin or an oral medication for diabetes (Sulfonylureas (Chlorpropamide [Diabinese], Glyburide [Micronase, Diabeta, Glynase PresTab], Glipizide [Glucotrol, Glucotrol XL], Glimepiride [Amaryl], Tolbutamide, Acetohexamide, Tolazamide [Tolinase]), Meglitinides (Nateglinide [Starlix], Repaglinide [Prandin]), Thiazolidinediones (Rosiglitazone [Avandia], Pioglitazone [Actos]), Biguanides (Metformin [Glucophage, Glucophage XR, Riomet, Fortamet, Glumetza]), Alpha-Glucosidase Inhibitors (Acarbose [Precose], Meglitol [Glyset]), DPP-4 Inhibitor (Sitagliptin [Januvia], Saxagliptin [Onglyza], Linagliptin [Tradjenta]), Alpha-glucosidase Inhibitors (Acarbose [Precose], Miglitol [Glyset]), Combination tablets (Metaglip [glipizide/metformin], Prandimet [repaglinide/metformin], Glucovance [glyburide/metformin], Janumet [sitagliptin/metformin], Avandamet [rosiglitazone/metformin], Avandaryl [rosiglitazone/ glimepiride], Duetact [pioglitazone/glimepiride], Actoplus Met [pioglitazone/metformin]), Kombiglyze [saxagliptin/metformin]) Charlson Co-morbidity Score: *Chronic ischemic heart failure: 411-414.9 *Peripheral vascular disease: 441, 443.9, 785.4 *Congestive heart failure: 398.91, 402.01, 402.11, 402.91, 404.01, 404.03, 404.11, 404.13, 404.91, 404.93, 428 *Chronic pulmonary disease: 490-496.99 *Chronic liver disease and cirrhosis: 571-572.99 *Chronic renal failure: 581-583.9, 585, 586 *Cerebrovascular disease: 430-437.9 *Dementia: 290-290.9 *Diabetes: 250.00, 250.02, 250.10, 250.12, 250.20, 250.22, 250.30, 250.32, 250.40, 250.42, 250.50, 250.52, 250.60, 250.62, 250.70, 250.72, 250.80, 250.82, 250.90, 250.92, 790.2, 790.21, 790.22, 790.29, at least 90 consecutive days supply of insulin *Paralysis: 342.-342.9 *Ulcers: 530.0-530.3, 531.0-3, 532.0-3, 534.0-3 All information will be extracted and a database curated with the sole intention of use for epidemiology research. The period of performance shall be for twelve (12) months. 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 2:00 PM 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-130139-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-130139-RR/listing.html)
- Place of Performance
- Address: Contractor's site, United States
- Record
- SN03162519-W 20130828/130826235518-ba9e1bced284ba5972ec23c1716ee051 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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