NIH NEUROBIOBANK TISSUE TOXICOLOGY

Synopsis: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) the classification/ type of small business (e.g., whether they are small businesses, 8(a) small businesses, HubZone small businesses, service-disabled veteran-owned small businesses, veteran-owned small business, economically disadvantaged women-owned small business (EDWOSB) or women-owned small business (WOSB)) and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. 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. Teaming and partnering arrangements among small businesses is encouraged. A. Background The National Institutes of Health (NIH) Neurobiobank, comprised of the National Institute of Mental Health (NIMH), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Neurological Diseases and Stroke (NINDS), will be supporting an as yet unspecified number of Brain and Tissue Repositories in the near future. These Brain and Tissue Repositories (BTRs) will be federated through an IT Portal to increase coordination and sharing of valuable resources. Centralized toxicology testing of brain and other tissues from these repositories is one way to save money and increase standardization amongst the BTRs. Economies of scale and increased efficiency could be achieved by having all brains acquired through BTRs screened under a single tissue analysis contract. The NIH Neurobiobank is seeking a tissue testing service that can provide validated, high quality toxicology and infectious disease testing services for these NIH supported BTRs. B. Purpose and Objectives The purpose of this acquisition is to provide services that can assay up to 750 samples/yr. These assays will include screens for multiple drug classes/types, multiple infectious diseases and environmental exposures. The majority of agents to be tested under this program will be drugs of abuse or psychotropic drugs. The Contractor may be required to do a combination of assays on a given tissue, or assess a particular drug in several tissue types (e.g. blood, brain, and hair) according to the needs of investigators requesting services and NIH Neurobiobank programmatic priorities. C. Project Requirements Qualified sources will be required to assay specimens, document and prepare reports of results. The reports must be electronically submitted to a third party interactive web site (508c compliant) herein referred to as the NIH Neurobiobank Portal. The anticipated contracts will include Standard Operating Procedures (SOPs) and protocols and Quality Assurance/Quality Control requirements for prospective evaluation of short and long term specimen integrity, viability and function. Qualified sources must have: 1. An infrastructure to actively receive, assay and report results from up to 750 brain, blood, and/or hair samples/year. Toxicology testing facility must operate in accordance with all applicable state and local laws and Federal regulations. 2. The ability to report results to the NIH Neurobiobank Portal, a third party interactive web site (508c compliant), as the data are generated. 3. Sufficient capacity to process and assay 500-750 biologic specimens. This includes sufficient ultra-freezers; and additional storage and processing capacity should be available for non-frozen material including fixed tissues. Provide a climate-controlled facility with the capacity to maintain room temperatures such that freezers can function normally when all equipment is operating, with sufficient back up power to maintain normal operation in a power failure. Provide enough back-up freezer space to accommodate the failure of at least one freezer. Complete transfer of the contents of a freezer shall occur within two (2) hours of an initial freezer failure. Provide adequate, on-site back-up power to handle complete electrical power failure. 4. Information Technology (IT) Security that is compliant with the Federal Information Security Management Act of 2002 (FISMA) to ensure security of all data generated over the life of the contract. 5. Appropriate shipping licenses and permits from local, State, Federal and International authorities for the safe import, storage and distribution of biological specimens, according to current regulatory guidelines, as applicable by time of award. 7. Procedures and protocols for safe handling of potentially hazardous and infectious materials. D. Anticipated Period of Performance June 30, 2014 - June 29, 2015 (with yearly options to extend term of the contract through June 29, 2023) E. Capability Statement/Information Sought Capability statements should clearly state/describe your ability, experience, and resources to design and carry out the services listed above, including: 1. Staffing expertise and credentials that would be working on this project, including their commitment to this project. 2. Respondent's DUNS number, organization name, address, point of contact, and size and type of business (e.g.,8(a), HUB Zone, etc) pursuant to the applicable NAICS code; NOTE: THE APPLICABLE NAICS CODE FOR THIS REQUIREMENT IS 621511, $30 Million); 3. Information on the management structure and history of your organization; and 4. Any other resources available to perform this work. You are encouraged to limit your response to fewer than ten (10) pages and must specifically address each of the requirement specific items requested. Responses to this notice should be received no later than the posted due date, and can be sent either by mail or e-mail to the point of contact listed. If using the U.S. Postal Service or commercial overnight services, please send an original plus five (5) copies of your response. Note: for commercial overnight services, use the Rockville, MD. 20852 address. F. 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, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, response to this notice will not be considered adequate responses to a solicitation. G. 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 solicitations(s).