Hosted Commercial In-Life Data Collection and Management System for NTP

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) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; 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. The NIEHS is seeking capability statements from interested and qualified small businesses to provide a hosted commercial in-life data collection and management system to meet the specific needs of the National Toxicology Program. The National Institute of Environmental Health Sciences is requesting information to determine the availability of interested small business sources to provide the aforementioned system, as outlined herein. Background The National Institute of Environmental Health Sciences (NIEHS) is one of 27 Institutes and Centers of the National Institutes of Health (NIH), Department of Health and Human Services (DHHS). The mission of the NIEHS is to reduce the burden of human illness and disability by understanding how the environment influences the development and progression of human disease. The Division of the National Toxicology Program (NTP) is an interagency program whose mission is to evaluate agents of public health concern by developing and applying tools of modern toxicology and molecular biology. In carrying out its mission, the NTP studies the effects of environmental agents in laboratory studies, which are performed predominantly at contract laboratories and then reviewed by the NTP. System Capabilities and Support A suitable system should have the following potential capabilities: 1. Access to a hosted commercial in-life data collection and management system for use by personnel of the NTP and contract laboratories carrying out NTP-directed research. 2. Provide user access across multiple locations 3. Statistical tests, upload capability and usability requirements 4. Capability to house additional NTP study types in the system 1. Access to a hosted commercial in-life data collection and management system for use by personnel of the NTP and contract laboratories carrying out NTP-directed research. The system should have the ability to collect data from in-life studies, e.g. body weights from balances calibrated using the system, feed and water consumption using calibrated balances, clinical observations using the NTP glossary. Data will also be collected in the necropsy room, e.g. organ weights from calibrated balances, gross observations and tissue/site linkage using the NTP glossary and validation rules. For developmental toxicology studies fetal pathology observations using the NTP glossary must be collected, and for reproductive studies the system shall support pairing, mating, littering, pup and litter observations. The system should also support histopathology observations using the NTP modified histopathology glossary. The reproductive studies performed by the NTP and should be housed in the system cover 1 to 2 years in the laboratory, and include three litters per breeding pair generation, three generations (F0 breeder generation plus F1 and F2 generations) in the one study, and approximately 3,000 animals. The developmental and acute toxicology modified one-generation studies are initiated with pregnant animals, and require that the F1 generation animals be transferred to up to 8 different cohorts within one study. The system should function in compliance with Guidance from the Food and Drug Association (FDA) for Good Laboratory Practice (GLP) as outlined in 21 CFR Part 11, with audit trails and security controls on data input and change. Within this environment, the system should have the capability to support real-time access by up to six different laboratories in such a way that the data from one laboratory is not viewable or otherwise accessible by users from another laboratory, while all sets of data are available to NTP scientists. The Contractor should have the capability to supply a help-desk staffed from 7AM to 11PM EST, seven days a week, and have the capability to provide annual refresher training for all users. 2. Provide user access across multiple locations The Contractor shall provide accessibility to the system in user blocks of 25. Contractor should have the ability to provide start up training for new users and provide assistance connecting laboratory instruments at any new sites to the system. 3. Statistical tests, upload capability, and usability requirements The system should have the capability to support setting work schedule tasks by study day as well as by subject start date, mated date, birth date and study week. The NTP collects estrous cyclicity data over 21 days on each animal, and plans to upload the data on a per-animal basis for the entire 21 days. The system should support upload of retrospective data using a time by animals, an endpoint by animals, or a time by endpoint matrix entry screen. The NTP control database housed within the system should have the ability to contain data on the incidence of histological, fetal pathology and other findings in control animals from all studies completed using the system, with dates of study start and termination, strain of animal, diet, route of administration and lab performing the study indicated in the database and available for filtering by the user. The system should have the capability to construct tests for extended periods of estrus and diestrus based on a Markov chain model proposed by Girard and Sager (1987). The NTP uses different mean calculations for summarizing litter data: (a) mean of means for (e.g.) pup weights; (b) mean of all in group ignoring litter (e.g. total dead pups for a group); (c) repeated measure (for an endpoint from litters a, b, c in RACB protocol) - mixed effects ANOVA across generations; (d) developmental marker attainment, BW at birth - nested ANOVA by litter size (2 factors - dam and litters nested within dam); (e) covariate calculation of e.g. day of attainment of developmental markers using wean weight and/or litter size. The system should have the capability to carry out statistical analyses for possible dose-related effects on survival: Cox's method for testing two groups for equality and Tarone's life table test to identify dose-related trends. The system shall use the Poly-k test (Bailer and Portier, 1988; Portier and Bailer, 1989; Piegorsch and Bailer, 1997) to assess neoplasm and non-neoplastic lesion prevalence. Report Capabilities The system should have the capability to produce the following reports: Cross-generation report with two columns per group per endpoint. The first shall be the value for that endpoint for a given sire or dam, the second shall be the summary value for the pups (male, female or both, as the endpoint suggests) from that dam or sire. The NTP desires that this be extended to the three generations in the study during the contract. Multi-litter report with the results of three or more litters in a generation plus a summary value for all the litters in a group combined. Comparison of multiple groups in a study for any set of 4 to 12 groups. This shall not be limited by generation or litter number. 4. Capability to house additional NTP study types in the system The NTP will use the system to perform studies in addition to reproductive and developmental toxicology, including Immunotoxicology, Neurotoxicology, Carcinogenicity, Acute Toxicology. These should be housed within the same system to leverage the glossaries and historical data within the system. In addition, the NTP plans to use the system for a cross-fostering study design. In this design all the pups in a litter are moved to the cage of a foster dam, and the pups from the foster dam are moved to the cage of a third dam and so on until no pup in the foster group is housed with its birth mother. Other Important Considerations The anticipated period of performance will be from 01 June 2012 through 31 May 2022, with one (1) year for the base period, and nine (9) one (1) year Options. The base period shall encompass the time for software installation, validation, and training. Section 508 standards are applicable to this requirement. When acquiring Electronic and Information Technology (EIT), the government is obligated to meet the accessibility standards at 36 CFR Part 1194 and Section 508 of the Rehabilitation Act of 1973. For more information on these standards, please see: http://www.section508.gov. Capability Statement Interested organizations are required to submit their Capability Statements, not to exceed twenty (20) single sided pages in length (including all attachments, resumes, charts, etc.). The Statement shall be presented in single space and using a 12-point font size minimum that clearly details the ability to perform the aspects of the notice described above. The Capability Statement may include a standard product brochure or other similar marketing materials. However, a standard product brochure, or other standard marketing materials, will not be considered to be sufficient in responding this this Sources Sought notice. Respondents must provide as part of their responses information concerning the following: 1. Current in-house capability and capacity to perform the work 2. Completed projects of a similar nature, references, and other related information 3. Complete description of the system's capabilities Respondents are advised to indicate any information that is considered to be proprietary, classified, confidential, or sensitive. Responses shall include the following in their submission: 1. Organization Name 2. Organization Address 3. DUNS Number 4. Point of Contact (including name, title, address, telephone number, fax number, and email address) 5. Size status for the NAICS Code (518210) 6. Certified as HUBZone, 8(a), Woman-Owned, Small Disadvantaged and/or Service Disabled Veteran-Owned or Veteran-Owned Small Business concern. 7. Current GSA Schedule appropriate to this Sources Sought Notice (if applicable) Respondents shall respond to this Sources Sought Synopsis no later than 2 December 2011, 5:00 PM (EST). All responses must be received by the aforementioned date and time in order to be considered. All Capability Statements sent in response to this Sources Sought notice must be submitted electronically (via email) to Victoria Cunningham, Contract Specialist, at cunninghamva@niehs.nih.gov in MS Word or Adobe Portable Document Format (PDF). For any questions, please contact: Victoria Cunningham Contract Specialist Email: cunninghamva@niehs.nih.gov Phone: 919-541-4027 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 deems 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, responses to this notice will not be considered adequate responses to a Solicitation.