SOLICITATION NOTICE
R -- database of patients for Alcohol Use Disorder (AUD)
- Notice Date
- 7/24/2018
- Notice Type
- Presolicitation
- 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
- NICHD201800063
- Archive Date
- 8/21/2018
- Point of Contact
- Amber Harris, Phone: 3014028778
- E-Mail Address
-
amber.harris@nih.gov
(amber.harris@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND- NAME). The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) intends to award a purchase order without providing for full and open competition (Including brand-name) to KAISER FOUNDATION HEALTH PLAN INC for access to Kaiser Permanente's database of patients for Alcohol Use Disorder (AUD) and a variety of health outcomes from the use of alcohol. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 813920 with a Size Standard $15,000,000. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-98 This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). PERIOD OF PERFORMANCE BASE YEAR 08/15/2018 thru 08/14/2019   Place of Performance National Institutes of Health National Institute on Alcohol Abuse and Alcoholism 5635 Fishers Lane Rockville MD 20852 DESCRIPTION OF REQUIREMENT 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 KAISER FOUNDATION HEALTH PLAN INC 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 KAISER FOUNDATION HEALTH PLAN INC 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. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.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. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Monday, August 6, 2018 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov. Assessment of Capability Lowest Price Technically Acceptable
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NICHD201800063/listing.html)
- Place of Performance
- Address: 5635 Fishers Lane, ROCKVILLE, Maryland, 20852, United States
- Zip Code: 20852
- Zip Code: 20852
- Record
- SN05004701-W 20180726/180724231042-fa436b8c39854a4db8ff4922e405d392 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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