SOLICITATION NOTICE
A -- Chemistry Services for the National Toxicology Program (NTP)
- Notice Date
- 9/11/2013
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Environmental Health Sciences, Office of Acquisitions, Office of Management, 530 Davis Drive, Durham, North Carolina, 27713, United States
- ZIP Code
- 27713
- Solicitation Number
- NIHES2013180
- Point of Contact
- Patrick J Barbour, Phone: 919-541-7596, Jennifer Smith, Phone: 919-541-0424
- E-Mail Address
-
barbourp@niehs.nih.gov, smithj3@niehs.nih.gov
(barbourp@niehs.nih.gov, smithj3@niehs.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Description This notice announces the intended release of Solicitation number NIHES2013180. The National Institute of Environmental Health Sciences is soliciting proposals for the purpose of providing Chemistry Services for the National Toxicology Program (NTP). The objective of this project will be to provide chemistry services for the NTP to include program management, logistics and handling, characterization, formulation, biosample analysis, animal studies, special studies and high throughput screen (HTS) activities. Up to three (3) contract awards will be made with only one (1) award permitted per contractor. Major tasks required include the following: A. Program Management Program management includes all of the following: 1. An effective Quality Program, consistent with the requirements of the Food and Drug Administration Good Laboratory Practices for Nonclinical Laboratory Studies (FDA GLP Regulations; Federal Register, 12/22/78, Part II et seq. http://www.fda.gov/ohrms/dockets/98fr/980335s1.PDF). 2. An effective health and safety program which ensures that work performed under the contract is done safely with provision of adequate oversight so that work is completed in a safe manner. 3. Appropriate animal facilities managed in accordance with the requirements of the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International and the NIH Office of Laboratory Animal Welfare (OLAW). 4. Effective communication between the contractor and the NTP, including implementation of an appropriate Information Management System. 5. Accurate, timely reporting of financial and administrative data, and results of all work done on the contract in accordance with the contract requirements and the NTP Chemistry Specifications. 6. Appropriate usage of staff expertise and facilities to ensure that assigned work is completed in a timely and cost effective manner. B. Logistics and Handling Logistics and handling includes all activities pertaining to procurement, handling and shipment of chemicals, test articles, and samples produced in support of all NTP activities and programs. All activities in this category shall be performed in accordance with the requirements set forth in the NTP Chemistry Specifications. 1. Logistics and Handling typically involves performing any or all of the following activities: a. Procuring chemicals or test articles needed for NTP studies and research activities. 1. Procurement of large quantities, up to 200 kg of a chemical or test article may be required. 2. Procurement of non-commercial chemicals, e.g. reactive intermediates may be required. 3. Procurement of non-standard chemicals or test articles, including dietary supplements, extracts, or nanomaterials, may be required. b. Repackaging, milling, blending, storing, aliquoting, homogenizing, or photographing a chemical, test article or sample. c. Shipping and arranging for shipment of chemicals, test articles, and/or samples to NTP-designated laboratories or research facilities. d. Receiving chemicals, test articles, and/or samples from such laboratories or facilities. e. Developing protocols for chemical handling and reanalysis, and dose formulation and analysis. 2. Logistics and handling includes the following Functional Activities: • Chemical Procurement (CP) • Chemical Handling (CH) • Chemical Storage (CS) • Shipment (SHIP) • Protocols Development (PD) C. Characterization Characterization includes all activities related to establishing the identity and determining the purity of a chemical, test article or sample, including developing methods needed to perform the analysis. All activities in this category shall be performed in accordance with the requirements set forth in the NTP Chemistry Specifications. 1. Characterization typically involves performing any or all of the following: a. Determination of physical properties and comparison to literature values b. Elemental analysis c. Establishing identity and/or structure d. Purity e. Water content f. Long-term chemical stability g. Log P or similar solubility parameter 2. Characterization includes the following Functional Activities: • Comprehensive Chemical Analysis (CCA) • Chemical Identity and Purity Screen (CIPS) • Multiple Chemical Identity and Purity Screen (MIPS) • Low-Level Impurity Determination (LLID) • Chemical Reanalysis (CRA) D. Formulation Formulation includes all activities related to dose preparation, mixing, and analysis of formulations containing a chemical, test article, chemical class, or sample in a variety of vehicles (e.g., corn oil, water, aqueous methylcellulose, feed, air, etc.). All activities in this category shall be performed in accordance with the requirements set forth in the NTP Chemistry Specifications. 1. Formulation typically involves performing any or all of the following activities: a. Determining solubility, suspendability, or syringeability of chemicals or test articles in a vehicle or vehicles designated by the COR. b. Developing methods for the formulation of a chemical or test article in a vehicle. c. Developing methods needed to perform an analysis of a formulation for a chemical or test article. d. Validating methods needed to perform an analysis of a formulation for a chemical or test article. e. Evaluating physical and chemical properties of a formulation, e.g., pH. f. Evaluating the stability of a formulation under several storage regimes, e.g., room temperature, refrigerator, and/or freezer conditions. g. Evaluating the stability of a formulation under conditions of dosing. h. Evaluating the homogeneity of formulations that are not solutions. i. Mixing and/or analyzing formulations using validated analytical methods. Formulations to be analyzed may be mixed by the chemistry services Contractor or supplied to the Contractor from an NTP-designated lab. j. Analyzing vehicles used in formulations for conformance to NTP, USP, or other specified requirements. k. Developing a common mixing and/or analysis method for a class of chemicals. l. Shipping a set of prepared dose formulations to an NTP-designated laboratory or researcher. 2. Formulation includes the following Functional Activities: • Preliminary Formulation Studies (PFS) • Formulation Development (FD) • Formulation Development and Validation (FDV) • Formulation Preparation (FP) • Formulation Analysis (FA) • Formulation Preparation and Analysis (FPA) • Formulation Preparation, Analysis, and Shipment (FPAS) • Vehicle Analysis (VA) E. Biosample Analysis Biosample analysis includes all activities related to determination of the concentration of a chemical, test article, chemical class, or sample, or its metabolites in a variety of matrices (e.g., blood, plasma, liver, kidney, fat, commercial dietary supplements, filters, etc.). All activities in this category shall be performed in accordance with the requirements set forth in the NTP Chemistry Specifications. 1. Biosample analysis typically involves performing any or all of the following activities: a. Developing and/or validating methods needed to perform the analyses. b. Evaluating the stability of the analyte in the matrix. c. Evaluating the distribution of the analyte in the matrix or between matrices. d. Determination of pharmacodynamic parameters and interactions of the chemical, test article, or sample (including metabolites) with biological systems (e.g., enzyme inhibition, adducts, etc.). 2. Biosample analysis includes the following Functional Activities: • Biosample Method Development and Analysis (BMDA) • Biosample Method Development and Validation (BMDV) • Biological Sample Analysis (BSA) • Extended Stability Study (EXS) • Biochemical Measurement (BCM) F. Animal Studies Animal studies include all activities related to determining the palatability and/or toxicokinetics of a chemical, test article or sample administered to an animal. All activities in this category shall be performed in accordance with the requirements set forth in the NTP Chemistry Specifications. 1. Animal studies typically involve performing any or all of the following activities: a. Palatability 1. Determined in species specified by the COR, typically rodents. 2. Palatability is measured by comparing consumption of dosed food and/or water, and animal body weights after up to 14 days of dosing, to control animals administered undosed food and/or water. b. Toxicokinetics 1. Typically consist of preliminary and definitive studies with small numbers of animals (typically < 100). 2. Preliminary studies are typically limited to one animal per time point and utilize 2 dose routes in 2 species. 3. Results of preliminary studies may be used to establish analyte concentration ranges to be validated during method development and to establish doses and time points for definitive studies. 4. Definitive studies typically obtain samples from multiple animals (typically 3) per time point. Definitive studies typically utilize ≥ 2 dose routes and 2 species. 5. Time course data from toxicokinetic studies are typically obtained in plasma or serum, although occasionally a time course in a particular tissue may be requested. 6. Toxicokinetic parameters calculated from time course data are described in the NTP Chemistry Specifications. 2. All animal studies require a signed study protocol, which has been reviewed and approved by the Contractor's Institutional Animal Care and Use Committee (or equivalent). 3. Animal studies include the following Functional Areas: • Palatability Study (PAL) • Preliminary Toxicokinetic Study (PTKS) • Definitive Toxicokinetic Study (TKS) G. Special Studies Special studies include all activities that are part of the overall scope of the contract, but are not contained within a single functional activity, or represent only a portion of a functional activity. All activities in this category shall be performed in accordance with the requirements set forth in the NTP Chemistry Specifications. 1. Special studies typically involve performing any or all of the following activities: a. Performance of a portion or subset of any functional activity described in the scope instead of performing the entire requirement. For example, developing and validating a formulation method without determining the stability of the formulation would be a special, because the formulation development and validation (FDV) activity requirement includes a stability study. b. Performance of a combination of several portions or subsets of two or more functional activities as a single activity. For example, validating a formulation analysis method and analyzing a formulation is a combination of parts of the FDV and formulation analysis activities. c. Performance of inhalation chamber studies, including inhalation feasibility studies to determine the ability of a chemical or test article to be generated as a uniform atmosphere in an inhalation chamber. d. Performance of the annual water analysis required to confirm the acceptability of water supplied to animals under study in the Contractor's animal facility. e. Drafting of manuscripts and/or meeting abstracts for submittal to peer reviewed journals or presentations for scientific conferences. All manuscript and presentation work must be initiated by the NTP via the COR. 2. Special studies include the following Functional Activities: • Special Chemical Activity (SCA) • Special Inhalation Studies (SIS) • Annual Water Analysis (AWA) • Publication Preparation (PUB) H. High Throughput Screen (HTS) Activities HTS activities include all activities that are part of the overall scope of the contract when performed in support of the NTP high throughput screening program. These activities fall into 2 broad categories: 1. Activities required to produce a full HTS 1536-well plate, which is subsequently tested in the Tox21 program. These activities are anticipated to be performed under Option 1, High Throughput Screen Activities and involve: a. Procurement of small amounts (typically < 10 g) of up to 1408 (typically) chemicals, chemical mixtures, or test articles. b. Performance of chemical handling to receive and/or repackage chemicals received and to prepare solutions of each chemical or mixtures of several chemicals in diemethyl sulfoxide (DMSO) or other suitable solvent at concentrations typically < 200 mM. c. Limited characterization (HTS Identity and Purity Screen) of procured chemicals and/or solutions. d. Dispensing of prepared DMSO solutions into 384-well quadrant plates, which will subsequently be assembled to form the full plate. e. Shipment of the 384-well quadrants to the NIH Testing Facility (currently NCATS). f. Optional HTS Activities include the following functional activities from the NTP Chemistry Specifications: • HTS Chemical Procurement (HCP) • HTS Chemical Handling (HCH) • HTS Identity and Purity Screen (HIPS) • Shipment (SHIP) 2. Processing of smaller numbers of HTS-related chemicals or test articles (typically, <1408) in support of NIEHS, NTP and other research programs may be performed under the Base contract during the Base and subsequent Option Years. 3. All activities in this category shall be performed in accordance with the requirements set forth in the NTP Chemistry Specifications. The anticipated effective date for each award is June 15, 2014. The performance period for each contract is expected to be a base contract of one (1) year plus nine (9) 1-year options for a total of ten (10) years. The contract will be a cost-reimbursement, level-of-effort type contract. For estimating purposes, the Government anticipates per award an approximate level-of-effort of 31,395 direct labor hours for the base contract period, 282,555 labor hours for all optional periods if all are exercised, and 25,712 labor hours for optional studies if all are exercised. Disclaimer This is not a solicitation. The expected release date of the RFP is September 25, 2013 with proposals due October 28, 2013. The requirement is unrestricted utilizing NAICS Code 541712. The solicitation will be posted on the FedBizOpps website. Interested firms who are unable to access the solicitation via the FedBizOpps website may request a copy of the solicitation by contacting the Contract Specialist listed herein. Please reference the solicitation number in your written request. All questions regarding this acquisition shall be submitted in writing via email to barbourp@niehs.nih.gov. Telephone inquiries will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIEHS/NIHES2013180/listing.html)
- Place of Performance
- Address: N/A, United States
- Record
- SN03184188-W 20130913/130912000113-31a1faf6cd9e1876ff27fe179c67440c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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