Chemistry_Support_RFI_SSN_Notice_2_17_26_package_1.pdf

Request for Information (RFI) and Sources Sought Notice (SSN)

Chemistry Support for the Division of Translational Toxicology (DTT)

National Institute of Environmental Health Sciences (NIEHS)

75N94026R00002

Description:

THIS IS A COMBINED REQUEST FOR INFORMATION (RFI) and SOURCES SOUGHT NOTICE

(SSN).

In accordance with FAR 15.201(e), this is a combined Request for Information (RFI) and Sources Sought Notice (SSN). This is an RFI and SSN notice issued for market research purposes only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. This RFI/SSN is issued for the purpose of obtaining knowledge and information for project planning purposes. There is no solicitation available at this time and no award will be made on the basis of responses received to this RFI/SSN.

The applicable NAICS code for this requirement is 541715 “Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)” with a small business size standard of 1,000 employees or less.

The National Institute of Environmental Health Sciences (NIEHS) is seeking information and capability statements from organizations of all business sizes. Please state whether your business size is small under the NAICS 541715(small business size standard is fewer than 1,000 employees) with experience in providing chemistry services in support of the Division of Translational Toxicology (DTT) research. Chemistry services shall be provided by the contractor to provide key pieces of information at each step of the DTT toxicological evaluation process.

BACKGROUND

The National Institute of Environmental Health Sciences (NIEHS), located in the Research Triangle Park, North Carolina, is one of the 27 Institutes and Centers comprising the National Institutes of Health. The NIEHS is a multidisciplinary research institution with the primary mission of conducting research to discover how the environment influences the development and progression of human disease in order to promote healthier lives. NIEHS focuses on basic science, disease-oriented research, global environmental health, clinical research, and multidisciplinary training for researchers.

The Division of Translational Toxicology (DTT) is an intramural division of the National Institute of Environmental Health Sciences, National Institutes of Health. DTT uses traditional and cutting-edge approaches to better understand how factors in the environment may impact human health. Such approaches include the conduct of toxicology studies on chemical, physical and biological agents, as well as non-chemical stressors, using in vitro and in vivo models of health and disease. Chemistry related activities, including chemical characterization, formulation support, biosample analysis, absorption, distribution, metabolism and excretion (ADME) and toxicokinetic (TK) studies, OMICS, In Vitro studies, and medium to high throughput chemistry support for in vitro toxicity screening are required for the successful execution of these studies.

The NIEHS issuing this RFI/SSN to ensure five (5) goals:

(1) facilitate early (pre-Request for Proposal [RFP]) engagement with industry, in accordance with FAR 15.201(e).

(2) improve NIEHS’s understanding of market capabilities and current vendor offerings for provision of the services as outlined in the Draft Statement of Work (See Attachment 1).

(3) collect input and build knowledge on the vendors’ capabilities to provide the services outlined in the Statement of Work.

(4) provide the specifications and set expectations with industry to support NIH’s commitment to fair competition, in accordance with FAR 5.401.

(5) determine the availability and capability of all qualified business sources.

REQUESTED INFORMATION

Respondents are encouraged to submit feedback and questions in order to identify any gaps in the SOW including areas requiring clarification, missing or ambiguous requirements, staffing considerations and any other general comments or concerns. Vendors may also provide specific comments and suggestions for refining the SOW to reflect clear guidance to industry and industry best practices, as well as provide additional information that they think is relevant for developing the acquisition strategy for this requirement.

Interested vendors should furnish the following information to NIEHS:

I. Comments on the Draft Statement of Work (SOW) (Attachment 2) II. Responses to RFI Questions (Attachment 3)

Note: Responses to the questions in Attachment 3 are welcome but not required. The questions are intended to provide the Government with feedback about the feasibility of the requirement and broaden the knowledge of vendor capabilities.

III. Vendor Business Information (Attachment 4)

SUBMISSION INSTRUCTIONS

The offeror shall provide an electronic version only of their response to this notice.

Responses shall include the organization's name, address, point of contact, size of business pursuant according to the North American Industrial Classification Code (NAICS) and must address all the technical information requested.

For qualified businesses submitting a Capability Statement in response to the SSN, the page limit is 15 pages using a font size 10 or larger. Responses will assist the Government in selecting the appropriate acquisition mechanism.

This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This is not a Request for Proposals. The Government DOES NOT intend to award a contract based on responses under this announcement. Interested parties shall not be reimbursed for costs associated with preparation of their responses. Any proprietary information should be so marked. Interested organizations presenting a Capability Statement in response to this Sources Sought announcement must identify their size status.

AII capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to the Point of Contact below in MS Word or Adobe Portable Document Format (PDF). The subject line must specify Sources Sought and Request for Information Notice 75N94026R00002. Facsimile responses will not be accepted.

Electronically submitted capability statements are due no later than 5:00 PM (Eastern Standard Time) on March 4, 2026. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND

TIME WILL NOT BE CONSIDERED.

The NIEHS reserves the right to determine whether to respond to questions and may consolidate responses to similar questions. If NIEHS decides to publish questions and responses, they will be posted for visibility to the public on sam.gov.

TELEPHONE RESPONSES WILL NOT BE ACCEPTED.

Attachments:

1. Draft Statement of Work – 19 Pages

2. Comments on the Draft Statement of Work (SOW) – 1 page

3. RFI Questions – 1 page

4. Business Information – 1 page

Links:

1. NIEHS Chemistry Specifications

Attachments/Links o RFI Attachment 1-Draft Chemistry SOW o RFI Attachment 2-Comments on Draft SOW o RFI Attachment 3-Reponses to Questions_Chemistry o RFI Attachment 4-Business Information o RFI Link to Chemistry Specifications: https://ntp.niehs.nih.gov/go/SS_chemistryspecs

Please send responses to this Request for Information (RFI) and Sources Sought Notice (SSN) announcement via e-mail to:

Sarah Bank, Contracting Officer Office of Acquisition and Logistics Management (OALM), OD Research and Development and Professional Services- Division B E-MAIL: sarah.bank@nih.gov

Primary Point of Contact:

Sarah Bank Contracting Officer Office of Acquisition and Logistics Management (OALM), OD Research and Development and Professional Services- Division B sarah.bank@nih.gov

Secondary Point of Contact:

Lisa Schaupp Section Chief Office of Acquisition and Logistics Management (OALM), OD Research and Development and Professional Services- Division B lisa.schaupp@nih.gov

DISCLAIMER AND IMPORTANT NOTES

This combined RFI and SSN is issued solely for information and planning purposes to facilitate the acquisition planning process. It does not constitute a Request for Proposal (RFP)/Request for Quotation (RFQ) or a promise to issue an RFP/RFQ in the future, nor does it restrict the Government as to the ultimate acquisition approach. This notice does NOT obligate the Government to award a contract or otherwise pay for the information provided in response.

Further, NIEHS is not seeking proposals through this RFI/SSN and will not accept unsolicited https://ntp.niehs.nih.gov/go/SS_chemistryspecs mailto:sarah.bank@nih.gov mailto:sarah.bank@nih.gov mailto:lisa.schaupp@nih.gov proposals. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published to SAM.gov Contract Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Any contract that might be awarded based on information received or derived from this RFI/SSN will be the outcome of a competitive process. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback with respect to any information submitted. Potential respondents should continue to monitor NIEHS announcements for additional information pertaining to this RFI/SSN. Please note that NIEHS will not respond to questions about the policy issues raised in this RFI/SSN. NIEHS may or may not choose to contact individual commenters. Such communications would only serve to further clarify written responses.

CONFIDENTIALITY. Information obtained as a result of this RFI/SSN may be used by the Government for program planning on a non-attribution basis. Respondents should not include any information that might be considered proprietary or confidential. All submissions become Government property and will not be returned. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Attachment 1-Draft Statement of Work

Chemistry Support for the Division of Translational Toxicology (DTT)

Draft Statement of Work

Section 1. Contract Objectives and Scope

1.1. Contract Objectives

The contract will provide chemistry services in support of DTT research. The type and extent of the support provided by this contract will be tailored to specific DTT research needs. Chemistry services will typically be provided by the contractor to provide key pieces of information at each step of the DTT toxicological evaluation process.

1.2. Scope

Independently, and not as an agent of the Government, the Contractor shall, in accordance with the terms and conditions set forth herein, furnish all qualified personnel, facilities, materials, and equipment (other than those furnished by the Government as specified herein), necessary to perform the chemistry services for a period of performance of up to ten years. An additional optional period of performance of six months is anticipated at the end of ten-year period.

Performance of this contract will involve Program Management procedures and technical activities in up to 8 Functional Areas as given below. Functional Activities under Functional Areas may be performed individually or in one or more combinations (see Functional Area 5, Special Studies). The Contractor is responsible for determining the level of effort required to perform the requirements defined by the Statement of Work, Section 2.

Contract Requirements (below). Detailed requirements for Functional Areas and Functional Activities are given in the DTT Chemistry Specifications:

https://ntp.niehs.nih.gov/go/SS_chemistryspecs.

1.3. Project Management

Project management (refer to Section 1 of the DTT Chemistry Specifications for details) includes but is not limited to an effective quality program, an effective health and safety program, appropriate animal facilities management, effective communication between the contractor and the DTT, accurate and timely reporting of financial data, administrative data, and technical data, and appropriate usage of staff expertise and facilities as described under Statement of Work, Section 2. Contract Requirements (below).

1.5. Functional Areas

1.5.1. Logistics and Handling (Functional Area 1)

Logistics and Handling includes all activities pertaining to procurement, handling, and shipment of test articles and samples produced in support of all DTT research. Activities in this area include, but are not limited to, the Functional Activities described in Section https://ntp.niehs.nih.gov/go/SS_chemistryspecs

2.1 of the DTT Chemistry Specifications and shall be performed in accordance with the requirements set forth there.

Logistics and Handling typically involves performing any or all of the following activities:

1. Procure and/or receive test articles, analytical standards, or samples (e.g., rodent plasma) from commercial and/or non-commercial sources.

2. Handle test articles to include, but are not limited to repackage, mill blend, prepare solutions, aliquot, homogenize, or photograph of procured material.

3. Ship and/or arranging for shipment of analytical standards, test articles, or samples to DTT-designated research laboratories.

4. Develop protocols for test article, handling and reanalysis, and dose formulation and analysis.

1.5.2. Characterization (Functional Area 2)

Characterization includes all activities related to establishing the identity and determining the purity of test articles, including developing methods needed to perform the analysis. Activities in this area include, but are not limited to, the Functional Activities described in Section 2.2 of the of the DTT Chemistry Specifications and shall be performed in accordance with the requirements set forth there.

Characterization typically involves performing any or all of the following activities:

1. Determine physical properties (e.g., melting point, color, optical rotation)

2. Establish identity and/or structure.

3. Establish purity.

4. Determine long-term storage stability.

1.5.3. Formulation (Functional Area 3)

Formulation includes all activities related to preparation, mixing, and analysis of dose formulations containing one or more test articles in a vehicle (e.g., corn oil, water, feed).

Activities in this area include, but are not limited to, the Functional Activities described in Section 2.3 of the of the DTT Chemistry Specifications and shall be performed in accordance with the requirements set forth there.

Formulation typically involves performing any or all of the following activities:

1. Determine solubility, suspendability, and/or syringeability of a test article in a vehicle or vehicles designated by the COR.

2. Develop methods for the formulation of a test article in a vehicle. For similar test articles (e.g., a chemical class), a common preparation method shall be considered.

3. Develop, qualify, and/or validate methods needed to perform an analysis of a formulation for test article concentration. For similar test articles (e.g., a chemical class), a common analysis method shall be considered.

4. Evaluate physical and chemical properties of a formulation, e.g., pH, suspendability.

5. Evaluate the homogeneity of formulations that are not solutions.

6. Evaluate the stability of a formulation under several storage regimes, e.g., ambient temperature, refrigerator, and/or freezer conditions.

7. Evaluate the stability of a formulation under conditions of dosing.

8. Prepare and/or analyze formulations using qualified and/or validated analytical methods. Formulations to be analyzed may be prepared by the Contractor or supplied to the Contractor from a DTT-designated laboratory. Ship formulations to a DTT-designated laboratory as directed.

9. Analyze vehicles used in formulations for conformance to DTT, US Pharmacopeia (USP), or other specified requirements.

1.5.4. Biosample Analysis (Functional Area 4)

Biosample analysis includes all activities related to determination of the concentration of an analyte (e.g., test article, a metabolite of the test article, DNA adduct, endogenous analyte) in a variety of matrices (e.g., blood, plasma, tissue). Activities in this area include, but are not limited to, the Functional Activities described in Section 2.4 of the of the DTT Chemistry Specifications and shall be performed in accordance with the requirements set forth there.

Biosample analysis typically involves performing any or all of the following activities:

1. Develop, qualify, and/or validate methods needed to quantitate analytes.

2. Evaluate the stability of the analyte in one or more matrices during storage.

3. Determine the concentration of an analyte in one or more matrices.

1.5.5. Special Studies (Functional Area 5)

Special studies include activities that are part of the overall scope of the contract but may or may not be contained within a single functional activity or represent only a portion of a functional activity. Activities in this category include, but are not limited to, the Functional Activities described in Section 2.5 of the of the DTT Chemistry Specifications and shall be performed in accordance with the requirements set forth there.

Special studies include, but are not limited to, performing any or all of the following activities:

1. Performance of a portion or subset of any functional activity. For example, only determining the stability of the formulation would be a special task, because the formulation development and validation activity requirement includes developing and validating a formulation development and analysis method, in addition to determining stability.

2. Performance of a combination of several portions or subsets of two or more functional activities as a single activity. For example, determining the test article identity and purity and formulation preparation and analysis is a combination of parts of the characterization and formulation analysis activities.

3. Performance of activities such as extraction and analysis of samples other than biological matrices (e.g., PM2.5 filters), nontargeted analysis of mixtures (e.g., botanical dietary supplements), identification of a metabolite of a test article in a biological matrix, partition coefficient determination of an analyte between two matrices, protein binding of an analyte, and inhalation feasibility studies conducted in a small chamber to determine the ability of a chemical or test article to be generated as a uniform atmosphere in an inhalation chamber.

4. Performance of activities to determine enzyme activity using probe substrates (e.g., use of midazolam to determine CYP 3A4 activity) and enzyme inhibition or induction following exposure to a test article (e.g., induction of CYP 1A1 following exposure to benzo(a)pyrene).

5. Development and application of prediction models such as Physiologically Based Pharmacokinetic (PBPK) Models to predict disposition of chemicals in animal or human models.

6. In vitro to in vivo extrapolation (IVIVE) of data to predict phenomena in vivo in biological systems.

7. Performance of the annual water analysis required to confirm the acceptability of water supplied to animals under study in the Contractor’s animal facility.

8. Preparation of products per DTT COR request (e.g., manuscripts for submittal to peer reviewed journals, meeting abstracts and presentations for scientific conferences).

1.5.6. Animal Studies (Functional Area 6)

To support animal studies, Functional Activities in Functional Areas 1-4 shall be conducted as appropriate including preparation and analysis of formulations for the study and analysis of study samples for analyte concentrations as described above or as directed by the COR.

Animal studies include all activities related to determining absorption, distribution, metabolism, and excretion (ADME) parameters and toxicokinetic (TK) parameters of a test article administered to animals, typically rodents, via a route or routes of interest (e.g., oral gavage, drinking water, feed, and/or intravenous). Animal studies will use either non-labelled (e.g., palatability) or radiolabelled (e.g., ADME) test articles. 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) and the DTT COR. Animal studies include the Functional Areas described in Section 2.6 of the of the DTT Chemistry Specifications and shall be performed in accordance with the requirements set forth there.

Animal studies typically involve performing any or all of the following activities:

1. TK Studies

a. The test article may be administered following single or repeated exposure via the route(s) of interest.

b. Typically measure concentration of analyte(s) (e.g., test article, metabolites) in a matrix (e.g., plasma, serum, tissues) over time following administration of test article.

c. Typically consist of studies with number of animals <100 per species.

d. Studies typically obtain samples from multiple animals (e.g., 3) per time point.

Definitive studies typically utilize up to 3 doses, 2 species, and both sexes following single or repeated exposure via the route of interest.

e. A preliminary study may be conducted using limited doses and number of animals per time points. Results of preliminary studies may be used to establish doses and time points for definitive studies, and, if needed, analyte concentration ranges to be validated in the biosample analysis method.

f. Analysis of data and determination of TK parameters from analyte concentration versus time course data are described in the DTT Chemistry Specifications.

2. ADME Studies

a. The test article may be administered following single or repeated exposure via the route(s) of interest.

b. Typically consist of studies with numbers of animals <100 per species.

c. Studies typically utilize up to 3 doses, 2 species, and both sexes and obtain samples from multiple animals (e.g., 3) per end point.

d. Typically measure radiolabel equivalents (e.g., total, bound) in blood, excreta, and tissues, over the study duration.

e. Qualitatively and/or quantitatively determine the test article-specific metabolites or products in blood, plasma, serum, tissues, or urine, as directed by the COR.

f. ADME parameters determined are described in the DTT Chemistry Specifications

1.5.7. Omics (Functional Area 7)

Omics activities include, but are not limited to, exposomics, proteomics, and metabolomics analyses, using state-of-the-art techniques, in biological matrices (e.g., cell lysates, urine, plasma) and/or environmental samples (e.g., water). Activities in this category include, but are not limited to, the Functional Activities described in Section

2.7 of the of the DTT Chemistry Specifications and shall be performed in accordance with the requirements set forth there. Omics analyses typically involve performing any or all of the following activities:

1. Utilizing nontargeted analysis approaches using state-of-the-art analytical systems (e.g., high resolution mass spectrometry, tandem mass spectrometry) to identify and/or quantify analytes (e.g. xenobiotics and/or their metabolites) in biological or environmental matrices (e.g., exposomics), as directed by the COR.

2. Utilizing nontargeted analysis approaches to identify and/or quantify perturbations in the endogenous metabolome (i.e., metabolomics) or proteome (i.e., proteomics) following an insult (e.g., exposure to a test article), as directed by the COR.

3. Utlizing state-of-the-art analytical systems (e.g., high resolution mass spectrometry, tandem mass spectrometry) and approaches to identify and/or quantify changes of the proteome (e.g., proteins, protein adducts) following an insult (e.g., exposure to a test article), as directed by the COR.

1.5.8. In Vitro Assays (Functional Area 8)

In vitro assays include all activities related to determining in vitro ADME/toxicity (ADMET) of a test article typically in in vitro rodent and human models, as directed by the COR. Activities in this category include, but are not limited to, the Functional Activities described in Section 2.8 of the of the DTT Chemistry Specifications and shall be performed in accordance with the requirements set forth there. Examples of activities that fall under this Functional Area include, but not limited to:

1. Performance of assay(s) using suitable model(s) to determine absorption of a test article (e.g., Caco-2 monolayer model to determine intestinal absorption).

2. Performance of assay(s) using suitable model(s) to identify transporters responsible for ADME of a test article (e.g., Pgp GloTM assay to determine Pgp substrates).

3. Performance of assay(s) using suitable model(s) to determine clearance and metabolism of a test article (e.g., cryopreserved primary rodent hepatocytes to determine hepatic clearance and metabolism).

4. Performance of assay(s) using suitable model(s) to determine bioaccumulation of a test article following repeated exposure (e.g., HepatoPac or plateable hepatocyte model to determine bioaccumulation).

5. Performance of assays using suitable model(s) to determine in vitro percutaneous absorption of a test article.

Section 2. Contract Requirements

This contract will be a cost plus fixed fee, level of effort type contract containing severable services.

2.1. Project Management

The Contractor shall comply with the Project Management requirements described below and in Section 1 of the DTT Chemistry Specifications during performance of all work under this contract and apply appropriate staff expertise and facilities to ensure that assigned work is completed in a timely and cost-effective manner.

2.1.1. Contract Servicing

1. To ensure timely start-up of contract work, the Contractor shall:

a. Ensure that all proposed staff are in place within 60 days after contract award.

b. Ensure that all the proposed management documents are in place, including but not limited to, the IT Security Plan, the Health and Safety Plan (HASP) and the Quality Management Plan (QMP) within 60 days after award. All management documents shall conform to the requirements, including delivery requirements, set forth in the DTT Chemistry Specifications.

c. Ensure that facilities are as proposed and in good working order within 15 calendar days after contract award.

2. Coordination and Continuity of Services

a. The Contractor shall provide for effective and efficient coordination of contract performance with DTT personnel and other DTT-designated contractors.

3. Travel Requirements

a. Under this contract, travel is authorized for activities pursuant to contract requirements, in accordance with the Office of Management and Budget (OMB) Memo, M-12-12. Travel is authorized, with prior approval of the COR, to professional meetings for the purpose of presenting work conducted under this contract, for meetings with DTT staff, or as specified by the COR.

2.1.2. Scheduling and Information Management

1. The Contractor’s work in this area shall comply with the requirements described in the DTT Chemistry Specifications.

2. The Contractor shall use a DTT PMS specified by the Government to document assignments, including, but not limited to, assignment descriptions and activities under the contract; and to communicate with the COR regarding the status of ongoing assignments. DTT will provide access to this system. The Contractor shall provide the computer hardware, appropriate software (e.g., browser, MS365, MS D365), and a high-speed internet connection to access these systems.

3. The Contractor shall employ an internal information management system (IMS) to track the work performed under the contract. This system shall:

a. Monitor the status of all on-going work, including schedule, hours, and costs.

b. Serve as a Master Schedule for all assignments performed under U.S. Food and Drug Administration (FDA) Good Laboratory Practice (GLP) compliance requirements.

4. The Contractor shall provide schedules and assignment cost estimates that accurately reflect the work to be performed for all assigned work. The Contractor shall update the estimated assignment costs and schedules in their internal IMS and the DTT PMS when there are changes to cost and/or schedule (e.g., assignments that do not proceed as planned or assignment priorities change).

5. The Contractor shall develop and implement an IT security plan that demonstrates compliance of their data management systems and practices with the Federal Information Security Management Act of 2002 (FISMA) and the Federal Information Technology Acquisition Reform Act of 2014 (FITARA). A DTT approved IT Security Plan is required prior to any work commencing under the contract and a copy of the proposed IT Security Plan shall be included in the contract proposal.

6. The Contractor shall comply with all applicable NIEHS/DTT Data Management Plans when submitting data to or holding/archiving data for the Government.

2.1.3. Quality Program

1. All work performed under this contract by the Contractor or any Subcontractor for any assignment that directly supports a DTT GLP study (e.g., toxicology study) shall comply with Food and Drug Administration Good Laboratory Practices for Nonclinical Laboratory Studies (FDA GLP Regulations; Federal Register, 12/22/78, Part II et seq. (CFR Code of Federal Regulations Title 21) unless specifically authorized by the COR or specifically excluded in the DTT Chemistry Specifications.

2. The Contractor shall establish an effective Quality Program, which addresses the requirements described below for any assignment that directly supports a DTT GLP study, including for work performed by any Subcontractor.

3. The Contractor’s quality program shall:

a. Conform to the requirements set forth in the DTT Chemistry Specifications.

b. Implement a comprehensive quality management plan (QMP), which addresses the requirements of the DTT Chemistry Specifications (see Section 1). A DTT approved QMP is required prior to commencement of any work under the contract and a copy of the proposed QMP must be included in the contract proposal.

c. Establish an effective quality control (QC) program to ensure that data obtained under this contract is of high quality.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58

d. Establish an independent Quality Assurance Unit (QAU) headed by a qualified Quality Assurance Officer (QAO).

e. Establish Standard Operating Protocols (SOPs) for all activities performed under this contract, as required by the DTT Chemistry Specifications.

f. Provide appropriate, ongoing staff training to ensure that all work conforms to contract requirements, DTT Chemistry Specifications, and where appropriate, to FDA GLP requirements.

2.1.4. Health and Safety

1. The contractor shall comply with the requirements in Section 3 of the DTT Chemistry Specifications.

2. The Contractor shall establish procedures to protect the health and safety of contract personnel performing work under this contract and provide staff with on-going training to ensure that they are aware of any potential hazards.

3. The Contractor’s Health and Safety Program shall:

a. Provide a qualified Health and Safety Officer.

b. Obtain and maintain full Drug Enforcement Agency (DEA) licensing (Schedules 1-

5) that provides for procurement, receipt, storage, and shipment of Schedule 1-5 substances.

c. Develop and implement a detailed health and safety plan (HASP) that demonstrates compliance with the Occupational Safety and Health Act (Public Law 91-596 84 STAT 1590 1970, amended 2004) and applicable state and local safety and health codes, standards, and regulations. A DTT approved HASP is required prior to any work commencing under the contract and a copy of the proposed HASP shall be included in the contract proposal.

d. Include safely dispose of hazardous wastes.

4. The Contractor shall comply with all federal, state, and local regulations for receipt, storage, handling, and shipping of hazardous chemicals, and with the National Cancer Institute (NCI) Safety Standards for Research Involving Chemical Carcinogens, DHEW Publication no. (NIH) 77-900 (1975), and subsequent revisions; and the NIH Guidelines for the Laboratory Use of Chemical Carcinogens, NIH Publication no 81- 2385 (May 1981), and subsequent revisions.

5. All shipments must comply with Department of Transportation (DOT) regulations and the DTT Specifications requirements for chemical shipments. International shipments must comply with all applicable regulations for the recipient’s location.

2.1.5. Animal Care and Use

1. The contract shall be conducted in compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, the Animal Welfare Act Regulations, the current edition of the Guide for the Care and Use of Laboratory Animals (the Guide), and all local, state or federal regulations and policies; and all animal care policies described in Chapter 6 of the Specifications for the Conduct of Toxicity Studies by the Division of Translational Toxicology at NIEHS (https://ntp.niehs.nih.gov/data/research/toxicology).

2. The Contractor shall have an approved animal welfare assurance statement on file with the NIH Office of Laboratory Animal Welfare (OLAW) at the time of contract award.

(Note: A contractor that does not have an OLAW-approved Animal Welfare Assurance may be selected but the Contracting Officer will have to initiate the process of obtaining an assurance from OLAW; contract funds may not be expended for animal work until the assurance has been approved).

3. The Contractor shall be accredited by the AAALAC.

4. If animal species regulated by the U.S. Department of Agriculture are involved in the contract, the Contractor shall be registered with the Secretary of Agriculture of the United States in accordance with 7 U.S.C 2136 and 9 CFR sections 2.25 through 2.28.

5. The Contractor and all contract facilities shall have a functional Institutional Animal Care and Use Committee (IACUC). All proposals for use of animals must be described in Animal Study Protocols that have been approved by the IACUC.

6. Animal experimental protocols, approved by the contractor’s IACUC, shall be deliverables to the COR prior to the commencement of work. These contractor-approved protocols shall also be available to the NIEHS ACUC.

7. The Contractor shall utilize a qualified Laboratory Animal Veterinarian to supervise the care and health of the animals.

https://ntp.niehs.nih.gov/sites/default/files/ntp/test_info/toxspecs/dtt_specs_compiled_508.pdf https://ntp.niehs.nih.gov/sites/default/files/ntp/test_info/toxspecs/dtt_specs_compiled_508.pdf https://ntp.niehs.nih.gov/sites/default/files/ntp/test_info/toxspecs/dtt_specs_compiled_508.pdf https://ntp.niehs.nih.gov/data/research/toxicology

2.2. Technical Activities

2.2.1. General Requirements

1. Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, procedures, materials, equipment, and facilities not otherwise provided by the Government, as needed to perform the work set forth below. Ongoing, recurring chemistry services are assigned as required to support DTT research activities. The Contractor shall perform each assignment according to the requirements described at the time of assignment, and in compliance with the requirements of the DTT Chemistry Specifications for each Functional Activity. The requirements described in the DTT Chemistry Specifications for each functional activity are typical of the work to be performed. Occasionally, subsections of a functional activity may be omitted for a particular assignment, or an assignment may combine aspects of more than one functional activity (see Special Studies of the DTT Chemistry Specifications) per COR direction.

2. The Contractor shall have a fully functional facility adequate to conduct the work described herein. An on-site evaluation of facilities and equipment may be made prior to award.

3. The Principal Investigator, Deputy Principal Investigator, Discipline/Task Leaders (e.g., staff person leading a Functional Area), and the Health and Safety and Quality Assurance Officers shall be employees (i.e., not consultants or subcontractors). All subcontracted work (e.g., DNA barcoding of botanical materials for authentication;

imaging mass spectrometry to determine xenobiotic distribution in tissues) must have a responsible staff member employed by the prime contractor who will oversee activities at the subcontractor.

2.2.2. Management of Technical Assignments

1. The day-to-day work performed under this contract will be managed as assignments, governed by assignment memos describing the work to be performed. Assignments shall be initiated by the COR to perform the Functional Activities described in the DTT Chemistry Specifications. The assignment description shall be provided by the COR to the Contractor, who shall document the assignment scope and description in the DTT PMS as described below. If a specific conflict arises between the SOW and the Chemistry Specifications, the Chemistry Specifications requirements shall take precedence.

a. The Contractor shall consult with the COR to develop a schedule for the proposed work that includes, at minimum, the following milestones:

i. The estimated start date of work for the assignment.

ii. The estimated completion date of lab work for the assignment. If no lab work is involved, the estimated lab work completed date will reflect the date the data package will be completed and work on the draft report will begin.

iii. The estimated date of issuance of the Draft Final report. The reporting requirements can be found in Attachment A and in Section 4 of the DTT Chemistry Specifications.

iv. The Contractor shall enter the agreed milestones into the DTT PMS.

b. The Contractor shall provide an estimated cost and hours budget, based on the work to be performed and post the estimated hours and cost to the DTT PMS.

c. The Contractor may not proceed with work on an assignment until the COR has reviewed and approved the proposed schedule and estimated cost in the DTT

PMS.

2. During performance of an assignment, the Contractor shall develop and follow assignment- or test article-specific SOPs for all work that employs validated analysis methods.

a. As work on an assignment proceeds, the Contractor shall update the DTT PMS with actual milestone dates as they are completed and revise estimated milestones when necessary. The Contractor’s intention to revise milestone dates must be communicated to the COR, who must approve any change to a milestone date.

b. As work on an assignment proceeds, the Contractor shall update the DTT PMS cost and hours budget on a regular basis and/or requested by the COR. The Contractor’s intention to revise the cost and hours budget for an assignment must be communicated to the COR.

c. The Contractor shall update the assignment workflow (e.g., status flag updated from ‘lab work in progress’ to ‘lab work complete’) in the DTT PMS when an assignment’s status changes. Specific status flags corresponding to assignment milestones will be established in the DTT PMS for all assignments.

d. The Contractor shall provide to the COR updated information on progress and/or changes in approach during the performance of each assignment.

i. Updates shall be posted to the DTT PMS in the form of notes and threaded discussions as they occur, or at least weekly, whichever is more frequent.

ii. Updates may also be required by the COR via other communication methods as needed (e.g., telephone). The Contractor shall summarize these communications in the DTT PMS.

iii. Updates shall include data, when applicable, in the form of tables, graphs, spreadsheets, and/or other documents, as specified by the COR.

3. The Contractor shall update the assignment workflow as work proceeds, compile all data supporting the assignment, and prepare and submit a Draft Final report according to the requirements set forth in the DTT Chemistry Specifications. If changes are requested by the COR after review of the Draft Final report, the Contractor shall make the changes and submit a revised Draft Final report.

4. Once the COR has approved the Draft Final report or subsequent revisions, the Contractor shall submit a signed Final Report according to the requirements set forth in the DTT Chemistry Specifications.

2.2.3. Ongoing Activities

The Contractor is expected to perform the activities as given below. Requirements for each Functional Area are described in detail in the DTT Chemistry Specifications.

1. Required Base and Option Years

a. Ongoing activities for the Base Contract (Year 1), base contract option years (Option Years 1 through 9) may include any or all Functional Activities of the Functional Areas 1 through 9.

b. Under the Base Contract and all Option Years 1-9, assignments may vary from year to year, but typical annual assignment numbers for each Functional Activity included in the Base Contract are given in Table 1.

2. Optional Item 1 for additional work (supplemental studies), if required, may include any Functional Activity or combination of Functional Activities. The requirements for Optional Item 1 will therefore vary each time Optional Item 1 is exercised.

3. Option for a 6-month period of performance after Option Year 9 includes all of the chemistry services in Functional Areas 1-9 supplied under the base contract.

Table 1 - Anticipated Annual Functional Activities for Base and Option Years

Functional Activity Number of

Assignments Logistics and Handling – Section 2.1 DTT Chemistry Specifications

Chemical Handling (CH) 5 Chemical Procurement (CP) 5 Chemical Storage (CS) 10 Shipment (SHIP) 30 Protocols Development (PD) 2 Multiple Chemical Handling (MCH) 5 Multiple Chemical Procurement (MCP) 5

Characterization – Section 2.2 DTT Chemistry Specifications Comprehensive Chemical Analysis (CCA) 4 Chemical Identity and Purity Screen (CIPS) 4 Chemical Reanalysis (CRA) 4 Multiple Chemical Identity and Purity (MIPS) 5

Formulation – Section 2.3 DTT Chemistry Specifications Preliminary Formulation Studies (PFS) 2 Formulation Analysis (FA) 2 Formulation Development (FD) 4 Formulation Preparation, Analysis, and Shipment (FPAS) 5 Vehicle Analysis (VA) 4

Biosample Analysis –Section 2.4 DTT Chemistry Specifications Biosample Method Development (BMD) 5 Biosample Analysis (BSA) 5

Special Studies – Section 2.5 DTT Chemistry Specifications Annual Water Analysis (AWA) 1 Special Chemical Activity (SCA) 5

Animal Studies – Section 2.6 DTT Chemistry Specifications Toxicokinetic Study (TKS) 2

Absorption, Distribution, Metabolism, and Distribution Study (ADMES) 1

Omics – Section 2.7 DTT Chemistry Specifications

Omics Studies (OMICS) 2 In Vitro Assays – Section 2.8 DTT Chemistry Specifications

In Vitro Assays (IVA) 2

2.2.6. Reporting Requirements

The Contractor shall provide accurate, timely reporting of financial and administrative data, and results of all work done on the contract, in accordance with the contract requirements found in Attachment A. Detailed requirements can be found in the DTT Chemistry Specifications Section 4 Reporting Requirements.

Attachment A: SOW Reporting Requirements and Deliverables

Chemistry Support for the Division of Translational

Toxicology (DTT)

Reporting Requirements and Deliverables

Attachment A- SOW Reporting Requirements and Deliverables

1. General Deliverables Requirements

A deliverable is the product of work done on this contract; the finished result of a step of work; or any unique and verifiable product, result or capability to perform a service that must be produced to complete a process, phase or project under this contract.

1. Required Reports (see below) for all contract activities shall comply with the requirements found in Chapter 7 of the DTT Chemistry Specifications (link: http://ntp.niehs.nih.gov/go/chemistryspecs) with respect to submission milestones, report formats and content, and reporting timeframes.

2. All submitted electronic copies of Required Reports must be Section 508-compliant. A description of requirements for 508-compliance of electronic documents can be found at http://www.hhs.gov/web/508/index.html

3. Required Reports

1. Contract Management Reports consisting of the Quality Management Plan (QMP), Health and Safety Plan (HASP), IT Security Plan (SSP), Standard Operating Procedures (SOPs), Chemical Inventory, and the Annual Water Analysis report.

2. Periodic Status Reports, including a Monthly Status Report (MSR) that describes all chemicals or samples shipped or received; all reports issued and their status (draft or final); health and safety, quality assurance, information and data management, and IT security activities during the month; the status of all active assignments; and current costs for active assignments, cumulative costs for the contract, including direct and administrative costs; an Annual Report consisting of a compilation of all reports completed during the just ended contract year; and a Final Report consisting of the annual report for the last year of the contract.

3. Functional Activity (Chemistry) Reports of the following report types:

1. Interim Reports consisting of preliminary results of an assignment in electronic format, usually as a data table. Interim reports are considered draft and do not need to be 508-compliant.

2. Formal Reports of all work performed for each assignment for each Functional Activity. These reports consist of a Draft Final report, submitted for review and approval of the COR and a Final report, which is the COR-approved version of the report.

3. Letter Reports, which may be issued in lieu of a formal Draft Final or Final report at the direction of the COR. Letter reports are typically issued for Special Studies http://ntp.niehs.nih.gov/go/chemistryspecs http://www.hhs.gov/web/508/index.html

Attachment A - SOW Reporting Requirements and Deliverables assignments, or canceled assignments for which work was performed and are formatted as a letter to the COR describing the work performed.

4. Other Reports

1. Study File: Hard copies of 1) individual files supporting an assignment, consisting of:

1. Certified copies of reports (e.g., formal reports, letter reports).

2. All of the raw data supporting the information presented in the report.

2. A Portable Document Format (PDF) copy of the study file. The PDF document is not required to be Section 508 compliant at this time.

4. Any incident or unforeseeable occurrences not listed in this document, or any physical modifications to the laboratory facilities, as well as any change in personnel that might have an impact on the conduct and results of studies, shall be reported immediately to the DTT.

2. General Reporting Requirements

1. The Contractor shall ensure that the reporting timeframes given below and for each Functional Activity are met.

2. All reports submitted under this contract shall reference the contract number, the title and type of report, any applicable DTT assignment number, and the represented period on the first page of the report.

3. Chemistry reports shall include a Header, an Executive Summary, a signed statement from the QAU, and copies of representative instrumental output, as needed, to support the data presented.

1. Chemistry reports shall be signed and dated by the Principal Investigator and the responsible Task Leader.

2. Chemistry reports shall include the name of the relevant Functional Activity in the report header.

3. Report headers, formats and contents shall conform to the requirements found in the DTT Chemistry Specifications

4. The Principal Investigator and the person who prepared the report shall sign financial reports and status reports.

Attachment A - SOW Reporting Requirements and Deliverables

5. All final deliverables in electronic format, except the PDF copy of the study file, must be Section 508 compliant e. Currently Section 508 compliance for PDF files is defined as passing the full compliance check found in Adobe Acrobat Pro DC 2022 or above with no reported errors and meets the PDF checklist specified at https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

6. Posting Electronic Reports

1. Electronic copies of all final chemistry reports shall be submitted to the DTT electronic program management system (PMS) Drop box at a URL specified by the

COR.

2. Electronic copies of contract management and status reports shall be submitted to the DTT PMS. The COR will designate a forum these reports.

3. Electronic copies of financial reports shall be emailed to the NIEHS Contracting Officer. The Contracting Officer will provide the email address to the Contractor.

7. Electronic Submissions: Email Addresses

1. All required fiscal, status, and technical reports shall be submitted electronically to the COR at the following address and within the times specified below:

NIEHS Contracting Officer Representative (COR) Name and Email: TBD

2. All reports required for the Contracting Officer shall be addressed and delivered to the Contracting Officer at the following address:

Contracting Officer (CO) Name and Email: TBD

8. Reporting Subcontracted Work

When reporting subcontracted work, the Contractor shall summarize the work in a report to the DTT and attach as an appendix the original report submitted to the

Contractor by the Subcontractor.

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

Attachment 2 – Request for Comments- SOW

RFI 75N94026R00002

Comments on the Draft Statement of Work (SOW)

NOT TO EXCEED 5 PAGES

Vendors are invited to submit comments on the Draft SOW. The comments should identify any gaps in the SOW including areas requiring clarification, missing or ambiguous requirements, staffing considerations and any other general comments or concerns.