NIH Neurobiobank Tissue Toxicology

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 or type of small business (e.g., whether they are small businesses; HubZone small businesses; service-disabled veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; women-owned small business (WOSB); economically disadvantaged women-owned small business (EDWOSB); or small disadvantaged businesses 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. THE APPLICABLE NAICS CODE FOR THIS REQUIREMENT IS 621511. 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 (BTRs) in the near future. These Brain and Tissue Repositories 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 1,000 samples each year. 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 herein referred to as the NIH Neurobiobank Portal and shall be Section 508 compliant. The anticipated contract(s) 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 1,000 brain, blood, and/or hair samples each year of the anticipated period of performance. 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, which is compliant with Section 508 as the data is generated. (See: http://www.hhs.gov/web/508/index.html) 3. Sufficient capacity to process and assay 750-1,000 biologic specimens. This includes a sufficient number of ultra-freezers; 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. See: Federal Information Security Management Act (FISMA; P.L. 107-347, Title III) 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 6. Procedures and protocols for safe handling of potentially hazardous and infectious materials D. Anticipated Period of Performance August 15, 2014 through August 14, 2019 E. Capability Statement Information Sought Capability statements shall clearly state/describe your ability, experience, and resources to design and carry out the services listed above and include: 1. (a) Staffing expertise including availability , experience, formal and other training; (b) current in-house capability and capacity to perform work; (c) prior completed projects of similar nature; (d) organizational experience and management capability; (e) examples of prior completed Government contracts, references, and other related information using 21 CFR Part 58- Good Laboratory Practices for Non-Clinical Laboratory Studies and International Conference on Harmonization (ICH) Guidelines. 2. Respondent's DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUB Zone, small disadvantaged, etc...) pursuant to the NAICS 621511. NOTE: THE APPLICABLE NAICS CODE FOR THIS REQUIREMENT IS 621511 (Industry Description- Medical Laboratories with Size Standard of $30 Million) 3. Any additional information or resources available to your organization for consideration of your potential capability in fulfilling this requirement. 4. Your organization's technical and administrative points of contact, including names, titles, addresses, telephone, and fax numbers, and email addresses. You are encouraged to limit your response to fewer than ten (10) pages and must specifically address each of the requirement specific items requested. Please include "Response to Sources Sought Notice HHS-NIH-NIDA(SSSA)-2014-086" in the subject line. Responses to this notice should be received no later than the posted due date, and shall be sent electronically via email to: Jeffrey Williams Contracting Officer Email: jeffrey.williams@nih.gov Phone: 301-402-1677 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).