MODIFICATION
B -- Creation and Curation of Databases to Support NCATS Projects
- Notice Date
- 1/9/2017
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-RFP-2016-118
- Archive Date
- 2/1/2017
- Point of Contact
- Lauren M. Phelps, Phone: 3014802453
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii)The solicitation number is HHS-NIH-NIDA-SSSA-CSS-2017-118 and the solicitation is issued as a Request for Proposal (RFP). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5- Simplified Procedures for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Center for the Advancement of Translational Sciences (NCATS) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to Rancho BioSciences, LLC.for curation of current bioinformatics databases and the creation of new databases to support the ongoing work of NCATS. This acquisition is conducted as non-competitive for a commercial item or service and is conducted under the authority of the FAR Subpart 13.5-Simplified Procedures for Certain Commercial Items and 13.501 Special documentation requirements and the authority of 41 U.S.C. 1901 and the statutory authority of 6.302-1(b)(4). Pursuant to FAR Subpart 13.501 (a) (1) (iii) the justification (excluding brand name) will be made available within 14 days after contract award or in the case of unusual and compelling urgency within 30 days after contract award. (iii)The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-92-1 dated December 19, 2016. (iv)The associated NAICS code 541990 and the small business size standard $15,000,000.00. This requirement is set aside 100% for small businesses. (v)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. (vi) Period of Performance is anticipated to be January 30, 2017 through January 29, 2018, with four (4) 12 month option periods. (vii)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: Specific Requirements: The contractor shall use the following sources to create, update and curate the database(s); 1.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 2.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? 3.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 4.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 5.FDA Orphan Product a.The contractor shall map orphan therapeutics to accurate UNIIs 6.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 6.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 (viii)The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (ix)The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. (a)The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers; offerors proposal will be evaluated against their ability to provide the required services as outlined in the statement of work. Technical and past performance is significantly more important than price. The evaluation factors are detailed below. Factor 1: Technical Approach The contractor shall detail in its technical proposal how it shall meet each of the project requirements. These details shall include the proposed approach to database creation, update, and curation for each of the subject areas identified in the statement of work. Approach shall be evaluated for conformance to Government requirements and for any ability to exceed requirements. Factor 2: Past Performance The Contractor shall provide a list of two (2) contracts or purchase orders completed during the past five (5) years, similar in size and scope to the requirements outlined in the purchase description. Experience must include the following information for each contract or purchase order listed: a.Name of Contracting Organization b.Total Contract Value c.Description of Requirement and Specific Responsibilities of the Offeror d.Contract Period of Performance Past Performance shall be evaluated for relevance to the current requirement. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (x)The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer. (xi)The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (Attachment Number One) (xii)FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. (Attachment Number Two) (xiii)The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. ‘There are no additional contract requirement(s) or terms and conditions applicable to this acquisition' (xiv)The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xv) Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. THE RESPONSE MUST INCLUDE BOTH A TECHNICAL DOCUMENT ADDRESSING THE EVALUATION CRITERIA AND A PRICE PROPOSAL. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." All responses must be received by January 17, 2017 at 9:00 A.M. (EST) and reference number HHS-NIH-NIDA-SSSA-CSS-2017-118. Responses must be submitted electronically to Ms. Lauren Phelps at lauren.phelps@nih.gov. Fax responses will not be accepted. (xvi)The name and telephone number of the individual to contact for information regarding the solicitation is Lauren Phelps at 301.480.2453.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-RFP-2016-118/listing.html)
- Place of Performance
- Address: The National Institutes of Health, The National Center for the Advancement of Translational Sciences, Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN04366592-W 20170111/170109234051-8968f8dc75593bb8ddce9ad2a37bf9df (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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