PRESOL | B | Joint NCI-VA Study on “Evaluating the safety and use of erythropoietin among cancer patients in the U.S. Department of Veterans Affairs (VA) medical care system”

FBO DAILY ISSUE OF AUGUST 27, 2008 FBO #2466
SOLICITATION NOTICE

B -- Joint NCI-VA Study on “Evaluating the safety and use of erythropoietin among cancer patients in the U.S. Department of Veterans Affairs (VA) medical care system”

Notice Date: 8/25/2008
Notice Type: Presolicitation
NAICS: 541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
Contracting Office: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
ZIP Code: 20852
Solicitation Number: NCI-80206-MM
Archive Date: 9/24/2008
Point of Contact: Melissa P Marino,, Phone: 301-402-4509, Caren N Rasmussen,, Phone: (301) 402-4509
E-Mail Address: marinome@mail.nih.gov, cr214i@nih.gov
Small Business Set-Aside: N/A
Description: The National Cancer Institute (NCI), Division of Cancer Control and Population Services (DCCPS), Applied Research Program (ARP) plans to procure on a sole source basis technical support for joint NCI-VA Study on “Evaluating the safety and use of erythropoietin among cancer patients in the U.S. Department of Veterans Affairs (VA) medical care system” from the University of Maryland, Baltimore, School of Pharmacy, Department of Pharmaceutical Health Services Research; 110 South Paca Street; Baltimore, MD 21202. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1 (b)(1). The North American Industry Classification System code is 541712 the business size standard is $7 million. The U.S. Department of Veterans Affairs’ (VA) medical care data systems provide extensive electronic information of extreme value to pharmacoepidemiologists. This data, which include information on in-patient and out-patient treatment, cause of death, lab results, prescriptions, and radiological procedures, is extremely valuable because it enables pharmacoepidemiologists to identify important associations between pharmaceuticals, patient response, and adverse events. This type of electronic health information is not currently available in other large population-based health-care delivery systems. NCI staff are working with collaborators within the VA to carry out important pharmacoepidemiological work using the rich VA data set. The joint NCI-VA project proposes to investigate the risks of erythropoietin use in cancer, particularly to identify factors associated with the high risk of adverse effects of erythropoietin, such as venous throboembolism (VTE) in patients with head and neck cancer undergoing radiotherapy. However, the full scope of this project exceeds the capacity of available in-house NCI staff. Therefore, NCI is initiating this contract to solicit high quality scientific and technical assistance, as well as support, for this project. The contractor shall: Develop study design and analysis plan in collaboration with research team Develop a detailed analysis plan Analyze study data Coordinate the writing of study manuscripts The period of performance will be from September 22, 2008 – July 21, 2009. The Drug Safety Research Unit (UM-DSRU) at the University of Maryland’s Department of Pharmaceutical Health Services Research in the University of Maryland, Baltimore, School of Pharmacy, is internationally recognized for its expertise in pharmacoepidemiology and the use of healthcare databases for drug safety research. Moreover, staff at the UM-DSRU has expertise with and access to data within the VA system, which is critical to this study. UM-DSRU staff are uniquely positioned and qualified to fulfill the requirements of this contract because they have experience working with the VA data and developing meaningful algorithms to create study variables, and because they are granted special access to VA data since some of the staff hold joint appointments as employees without compensation at the VA. In addition to having access to and expertise with the VA data, the UM-DSRU project staff has a combined total of approximately 50 years experience in epidemiology and are composed of a group of highly skilled professionals in the fields of information technology, statistics, computer programming, and pharmacology. The UM-DSRU investigators and staff have extensive experience working with large administrative claims and encounter data (e.g., Medicare, Medicaid, HMO, VHA, GPRD), secondary data (e.g., SEER-Medicare, FDA-AERS, NHANES, NAMCS, NHAMCS), and Primary data including pharmacy and medical information. Because of their ongoing work experience and relationship with the VA medical system in tandem with their knowledge of the epidemiological and statistical issues and issues related to cancer drug-related research, the UM-DSRU staff has the unique set of skills and access to data needed to perform this work. There are no other known investigators to the NCI who have the depth of experience and mix of expertise needed to ensure that these activities are completed in the outlined timeline. 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 shall 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 contracting office by 1:00 PM ET on September 9, 2008. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Melissa Marino, Contract Specialist at marinome@mail.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) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference NCI-80206-MM on all correspondence.
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B -- Joint NCI-VA Study on “Evaluating the safety and use of erythropoietin among cancer patients in the U.S. Department of Veterans Affairs (VA) medical care system”