CREATION AND CURATION OF DATABASES FOR MINING ANALYSIS

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. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The NCATS Chemical Genomics Center (NCGC) is tasked with identifying and developing novel small molecule leads against a wide spectrum of human disease targets, which it accomplishes by screening thousands of small molecules in collaboration with both intra-and extramural researchers. In pursuit of this goal, the Center has a strong internal transdisciplinary team of scientists who continually discover novel small molecules for application against a wide range of human diseases. As such, NCATS requires to create, update and curate of a database to support some of NCATS projects, such as NPC, Inxight, NPACT, Pharos and the Translator program. Purpose and Objectives: NCATS is in need of updating and curation of thier database of small molecules using the sources as outlined in the scope of work Project requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below: The contractor shall use the following sources to create, update and curate the database(s); Therapeutics (Approved Drugs) a. The contractor shall provide drug ingredients with code of federal regulations (CFR) (including inactive ingredients status). b. The contractor shall provide pre-1982 drugs/OTC drugs/drugs called out in the CFR, specifically the vendor shall provide i. Initial data/jurisdiction of marketing ii. Old Physicians' Desk Reference (PDRs) iii. New Drug Applications (NDA) Number iv. Sponsor and product name v. DESI (drug efficacy study implementation) status vi. US Pharmacopeia Status [especially pre-1950s drugs] c. The contractor shall indicate whether ingredient has been used markets abroad and shall match old, international pharmacopeias to GINAS (The Global Ingredient Archival System) d. The vendor shall provide raw materials for drug synthesis and curate the NCATS provided abstracted data from Pharmacology Manual Encyclopedia Therapeutics (Approved and Investigational Drugs; Combination Therapeutics) a. The contractor shall provide the following information for approved and investigational drugs and combination therapeutics: i. Peak therapeutic plasma concentrations (from pharmacokinetics (PK) studies published) ii. Halftime (T1/2) data iii. Tissue distribution --- not systemically available/distributes preferentially into tissues/CNS exposure iv. Tissue site of action v. Indication vi. Max dose in man vii. Max status viii. First date of publication ix. Last date of clinical development x. Tolerable dose in preclinical animal models (rodent and non-rodent) xi. Dose-limiting toxicity xii. Biochemical, cellular (including ex vivo), and in vivo potency in model systems xiii. Clinical trials prior to 2001 (Clinicaltrials.gov approx. start date) xiv. Taking Medical Subject Headings (MESH) and generating --- compound, indication, phase, sponsor, paper reference xv. Is therapeutic present in NCGC pharmaceutical collection? Off-label Use of Worldwide Therapeutics a. The contractor shall provide the following metrics on off-label use of worldwide therapeutics i. Indication ii. Dose regimen iii. Established standard of care iv. Clinical trials v. Case reports vi. Preclinical studies Clinical Trials a. The contractor shall map and curate ClinicalTrials.gov trials to Unique Ingredient Identifier (UNIIs) b. The contractor shall map and curate World Health Organization (WHO) trials to UNIIs FDA Orphan Product a. The contractor shall map orphan therapeutics to accurate UNIIs Therapeutic Hypotheses a. The contractor shall write short narratives for all approved and investigational therapeutics i. The narratives describe how a therapeutic works in terms of pharmacological action, pathway, and mechanism ii. Narratives is specific to each indication therapeutic is used for b. All therapeutics must be linked to public databases including: clinical trials, UNIIs, pathways, genes, proteins, disease models NCATS Pharmacologically Active Chemical Toolbox (NPACT) Annotations a. The contractor shall curate annotations for all compounds in the NCATS NPACT chemical library b. Annotations include biological targets, mechanisms, pathways, diseases, therapeutic categories c. Compounds include over 10,000 natural products, approved and investigational drugs, tool compounds, lipids, small peptides d. Annotations include brief narrative on how to use compound in vitro e. Annotations include brief narrative on how to use compound in vivo, if applicable Anticipated period of performance: Base Period of Performance - February 1, 2017 though January 31, 2018, with four one year option periods running through January 31, 2022. Capability statement /information sought. Respondents must provide, as part of their responses, a capability statement, information regarding respondents': (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information; The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The information submitted must be must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Mr. Brian Lind at e-mail address lindbj@nida.nih.gov. The response must be received on or before December 23, 2016 at 9:00 AMEastern Time. "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 presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. 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 solicitation(s)."