SOLICITATION NOTICE
R -- Database for Alcohol Use Disorder
- Notice Date
- 6/24/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 813920
— Professional Organizations
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6710B Rockledge Dr., Suite 1124, MSC7000, Bethesda, Maryland, 20892-7510, United States
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-16-103
- Archive Date
- 7/21/2016
- Point of Contact
- Patricia Haun, Phone: 301-443-7786
- E-Mail Address
-
haunp@mail.nih.gov
(haunp@mail.nih.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 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NIH-NICHD-16-103 and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-88. The North American Industry Classification (NAICS) Code is 813920 and the business size standard is $15.0M. However, this solicitation is not set aside for small business. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) intends to contract on a sole source basis with Kaiser Division of Research, 2000 Broadway, Oakland, CA 94612 to access Kaiser Permanente's database of patients for Alcohol Use Disorder (AUD) and a variety of health outcomes from the use of alcohol. Background Alcohol Use Disorder (AUD) is a complex and devastating disease, affecting 13.9 percent of Americans in a 1-year period and resulting in a range of medical, psychological, social, economic, and personal problems. Problem drinking costs the U.S. society more than $249 billion annually and causes nearly 88,000 deaths each year. Encouragingly, advances have been made in developing effective treatments for AUD, especially medications. Three medications are approved for alcohol dependence by the U.S. Food and Drug Administration (FDA): disulfiram, oral and long-acting injectable naltrexone, and acamprosate. In addition, nalmefene was approved in Europe by the European Medicines Agency (EMA) for the treatment of alcohol dependence. Barriers to progress in identifying new medications may lie in clinical trial design, including outcome measures. Perhaps a dozen different outcomes have been used in the 100 or so National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded alcohol pharmacotherapy trials conducted during the past 2 decades. Researchers have predominantly selected primary outcomes that reflect actual quantity and frequency of drinking, as opposed to measures of psychosocial or physical consequences of alcohol consumption, because drinking outcomes are more proximal to the effects of medications and thus appear to be more sensitive in detecting differences between experimental and placebo groups. However, a wide variety of choices exists even among drinking outcomes. The FDA has historically designated total abstinence as the only designated outcome for Phase 3 alcohol trials, a requirement of pharmaceutical companies to receive approval for a New Drug Application (NDA). However, more recently, the FDA has also deemed acceptable another outcome, the percentage of subjects with no heavy drinking days. Previous work has validated these outcomes by showing how reductions in drinking to these levels are associated with improvement in health outcomes. However, in order to achieve a successful response on these outcomes, subjects must substantially reduce their alcohol consumption often from very high starting levels. It is an empirical question whether lesser reductions in alcohol consumption, and alternative ways of operationalizing reduction, are also associated with improvements in health outcomes. For instance, the EMA accepts a 2-level reduction in a 4-level categorization of drinking risk levels (very high, high, moderate and low) defined by the World Health Organization (WHO) in terms of average volume (grams) of ethanol consumed per day (or per drinking day). Little information is available about the degree to which reductions in WHO drinking risk levels are associated with improvements in health outcomes. Moreover, it is unclear whether alternative WHO categories, using different volume cutoffs and alternative ways of expressing drinking (e.g., drinks per drinking day and heavy drinking days), would be produce different degrees of improvement in health outcomes. To produce generalizable and reliable results, validation of the WHO categories (and alternate conceptualizations) must be evaluated longitudinally in a large database of patients in a large healthcare system. Specific Project Requirements The contractor will be responsible for: I. Accessing Kaiser Permanente's database of patients with the following characteristics only: 1) alcohol consumption data with two time points at least 9 months apart (e.g., at patient intake and 9-months thereafter); and 2) a variety of health outcomes must be collected at the same two time points, and ideally after. II. Conducting analyses to validate how changes in WHO categories (and alternative conceptualizations) correlate with changes in health outcomes. Additional analyses must be conducted to explore moderators of this relationship (e.g., WHO category at intake, and the occurrence/severity of the health outcome at intake). III. Preparing one high quality manuscript for submission to a peer-reviewed journal describing the background, methods employed, results, limitations, future research and conclusions. Project Management The contractor will be responsible for: I. Providing for the overall management, integration and coordination of all contract activities, including the management and coordination of activities carried out under subcontracts. II. Providing a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation and timely completion of all projects carried out under this contract and effective communications with the Contracting Officer's Representative (COR) and the Contracting Officer. III. Provide a Principal Investigator with responsibility for overall project management and communications, tracking, monitoring and reporting on project status and progress, and recommending modifications to project requirements and timelines, including projects undertaken by subcontractors. A. EVALUATION FACTORS General Offerors are advised that an award under this solicitation shall be made to the Offeror whose proposal is determined by the Government to represent the best value to meet the Government's needs. The Technical Proposal shall receive paramount consideration in the selection of the Offeror for this acquisition. All evaluation factors, other than cost or price, when combined are significantly more important than cost or price. However, cost or price may become a critical factor in source selection in the event that two or more Offerors are determined to be essentially equal following the evaluation of all factors other than cost or price. In any event, The Government reserves the right to make an award to the Offeror whose proposal provides the best value to the Government. Best value means the expected outcome of an acquisition that, in the Government's estimation, provides the greatest benefit in response to the requirement. The technical evaluation shall be based on the demonstrated capabilities of the Vendor set forth in the Technical Proposal. The Government reserves the right to make an award without discussions if overall best value can be clearly determined and if no other Offeror would have a reasonable chance at award if discussions were conducted. Offerors shall be evaluated in accordance with the factors set forth below. Sub-factors listed under each factor are of equal importance to each other. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. 1. Understanding the Requirement (Technical and Management Approach) 70 Points A. Technical Approach (30 Points) a. Understanding and approach to supporting the technical task (aims) as identified in the Statement of Work. b. Specific methods and techniques to be employed with respect to these tasks (aims). c. Knowledge of the applicable technology to be used as described in the Statement of Work. d. Knowledge and experience with the business processes describing the suitability of the offeror (please provide a bibliography of publications relevant to the research). B. Management Approach (30 Points) a. Thorough and effective plan or the conduct of the task (aims) activities. b. Appropriate organization and allocation of personnel and resources needed to conduct the tasks (aims) outlined in the Statement of Work, including the methods for interaction and communication with the scientific, technical and administrative staff of NICHD. C. Qualifications (30 Points) a. Quality, depth and recent experience, education and training of the individual personnel to be assigned to the project. b. Successful performance of tasks similar to the tasks described in the Statement of Work. c. Ability to supply subject matter experts across the entire range of requirements if and as needed over the performance period. D. Past Performance and Organizational Experience (10 Points) a. Organization's history of successful completion of projects of similar nature, including the quality of technical performance and adherence to schedule and cost/price. b. Organization's past performance with projects and availability of facilities and equipment appropriate to the project in supporting biomedical research. B. COST/PRICE EVALUATION Offeror proposed price shall be evaluated on realism and reasonable for the Government to purchase the equipment. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques as described in FAR 15.404. Realism will be evaluated only on the offeror(s) inputs which the Government will use to determine the most probable cost/price for the equipment in a manner consistent with the offeror's proposal. Cost/Price realism analysis will be conducted in accordance with FAR 15.404-1(d). The result of the cost/price realism analysis will be considered in the making the best value tradeoff decision. C. ADDITIONAL EVALUATION FACTORS (These factors will not be evaluated ) Past Performance The Government will evaluate the quality of the offeror's past performance based on information obtained from references provided by the offeror, as well as other relevant past performance information obtained from other sources known to the Government. Evaluation of past performance will be a subjective assessment based on consideration of all relevant facts and circumstances. It will not be based on absolute standards of acceptable performance. The Government is seeking to determine whether the offeror has consistently demonstrated a commitment to customer satisfaction and timely delivery of services at fair and reasonable prices. The assessment of the offeror's past performance will be used as a means of evaluating the capability of the offeror. Thus, an offeror with an exceptional record of past performance may receive a more favorable evaluation than if it has an acceptable record. Past performance will not be scored, but the Government's conclusions about overall quality of the offeror's past performance will be influential in determining the merits of the offeror's proposal and in selecting the offeror whose proposal is considered most advantageous to the Government. By past performance, the Government means the offeror's record of conforming to ns and to standards of good workmanship; the offeror's record of forecasting and controlling costs; the offeror's adherence to contract schedules, including the administrative aspects of performance; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the Offeror's business-like concern for the interest of the customer. The Government will consider the number or severity of an offeror's problems, the effectiveness of corrective actions taken, the offeror's overall work record, and the age and relevance of past performance information. The lack of a performance record may result in an unknown performance risk assessment, which will neither be used to the advantage or disadvantage of the offeror. Deliverables At the completion of each completed analyses, contractor will provide results to NIAAA COR for review and feedback. One high quality manuscript for submission to a peer-reviewed journal describing the background, methods employed, results and conclusions. Limitations of the findings as well as directions for future research should be discussed. Final Closeout and Report The Contractor shall ensure an orderly, secure, and efficient closeout of the contract. A description of project activities and a summary of main scientific findings shall be provided in a Draft and Final Report, which will be reviewed and approved by the COR. The Draft Final Report shall be submitted no later than 14 calendar days prior to the completion date of the contract. The Final Report (approved by the COR and Contracting Officer) shall be submitted no later than 3 business days prior to the completion date of the contract. Kaiser Division of Research (DOR) uniquely possesses both the necessary Data and Contractor Requirements as presented in the Statement of Work. DOR houses an extremely rare database of approximately 1 million patients receiving primary care in a large healthcare system (Kaiser Permanente). The database includes sufficient granularity of alcohol consumption data so as to allow computation of all necessary drinking outcomes. Moreover, the database is longitudinal allowing for analysis of long-term health outcomes over time. This is a unique, national database and no other organization known to us possesses the volume and numbers of patient records with the required drinking data and repeated long-term healthcare follow-ups. The statistical team, at DOR possesses and demonstrated technical mastery of the data and statistical procedures to analyze these data, including sophisticated generalized linear models to demonstrate outcome change over time. Kaiser data was used for purposes similar to the needs of NIAAA, namely to validate other drinking outcomes, such as low-risk drinking. To accomplish the aim of this contract, the Contractor must have an extremely large database of patients in a large "real-world" healthcare system so that the analysis results will be generalizable and reliable. Moreover, the database must have sufficiently detailed measures of drinking so as to allow for computation of the WHO risk level categories, and ideally, allow for alternate conceptualizations of risk levels. Finally, the database must be longitudinal and contain drinking and health outcomes at two time points separated by at least 1 year in order to determine how changes in drinking are related to long term changes in health outcomes. Without these data points and volume of patients, we will not be able to sufficiently inform the Food and Drug Administration (FDA) on how changes in alcohol consumption relate to changes in health outcomes over time and provide a definitive answer on whether the WHO drinking risk level categories are an appropriate endpoint for pharmacotherapy trials to treat alcohol use disorder. The proposed contract action is for services for which the Government intends to solicit and negotiate with only one source under authority of the 41 U.S.C. 253(c) (1), FAR 6.302. The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. The provisions of FAR Clause 52.212-1 Instructions to Offerors - Commercial Items; FAR Clause 52.212-2, Evaluation - Commercial Items; FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items - Deviation for Simplified Acquisitions applies to this acquisition. The offeror must include their Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The clauses are available in full text at http://www.acquisition.gov/far/. Interested vendors capable of furnishing the government with the product specified in this synopsis should submit a copy of their quotation to the below address or via email to haunp@mail.nih.gov. Offers must also be accompanied by descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all of the foregoing requirements. Quotations will be due twelve (13) calendar days from the publication date of this synopsis or by July 6, by 12:00pm EST. via email or postal mail. The quotation must reference "Solicitation number" NIH-NICHD-16-103. Quotations sent by postal mail or other mailing services must be submitted to the following address: Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, Room 1159C, Bethesda, MD 20852. Attention: Patricia Haun, by the date and time mentioned above. Any questions must be sent via email to haunp@mail.nih.gov and must include solicitation# NIH-NICHD-16-103 in the subject line of email. Faxed copies/responses will not be accepted. Note: In order to receive an award, contractor must be registered and have valid certification in the SAM database @www.sam.gov.
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