National Institutes Of Health Tender

Pre-solicitation Notice - 75n96025r00001 national Institute Of Environmental Health Sciences (niehs) Assessment Of Immunotoxicity – In Vitro And In Vivo Assessment Of Immune Function this Notice Announces The Intended Release Of Solicitation Number 75n96025r00001. description this Pre-solicitation Notice Follows A Sources Sought Notice That Was Released On July 26, 2023, Under Notice Number Mmunotox_rfi_ssn_niehs_2023. the Acquisition Will Support And Assist The National Institute Of Environmental Health Sciences (niehs) By Providing All Services And Supplies Necessary To Conduct Research Studies To Evaluate The Potential For Test Agents Selected By The Division Of Translational Toxicology (dtt) To Modulate Immune Function Using Established In Vitro And In Vivo Models. with The Increasing Awareness Of The Need For Translational Toxicology And To Reduce The Use Of Animals, The Use Of In Vitro Methods To Assess Immune Function Will Be The Focus Of Dtt’s Research Efforts To Assess Altered Immunity. The Focus Of This Requirement Will Be To Provide Dtt With A Mechanism To Evaluate Chemical Induced Immunotoxicity By Determining: 1) Whether Chemical Or Therapeutic Agents Can Modulate The Immune Response Using A Battery Of In Vitro Tests To Measure Immune Suppression Or Stimulation In Response To Relevant Antigens; 2) Whether Chemical Agents Have The Potential To Induce Allergic Responses Using In Chemico And In Vitro Oecd Guideline Test Methods For Skin Sensitization As Part Of An Integrated Panel Of Tests And; 3) Evaluate The Potential Of A Test Agent To Modulate The Immune System Using A Comprehensive In Vivo Immune Testing Panel That Evaluates The Major Components Of The Immune System In The Developing Rat And/or Adult Mice Or Rats. In Addition, Because Immunology Is A Developing Science, It Is Expected That New And Improved Methodology Will Be Required To Maintain "state Of The Art" Evaluation. As An Additional Optional Capability Area, The Contractor Shall Identify Research Gaps And Conduct Methods Development And Validation To Support The Use Of New Approach Methodologies. mandatory Qualification Criteria mandatory Qualification Criteria Will Apply To This Requirement. The Qualification Criteria Establish Conditions That Must Be Met At The Time Of Receipt Of Final Proposal Revisions (fprs) By The Contracting Officer In Order For The Proposal To Be Considered Any Further For Award. The Following Mandatory Qualification Criteria Apply To This Requirement: mandatory Requirement: Conformance To Section 508 Standards electronic Documents And Reports Are Anticipated To Be Included In The Deliverables Of The Resultant Contract. 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. Section 508 Service Requirements For Information Content Are Applicable For This Requirement And Must Address 36 Cfr Part 1194. Organizations Submitting Proposals Will Be Required To Demonstrate Compliance With The Established Eit Accessibility Standards By Preparing An Hhs Section 508 Product Assessment Template. other Important Considerations key Personnel & Critical Personnel: The Following Personnel Are Considered Key Personnel By The Government: Principal Investigator And Deputy Principal Investigator. The Following Personnel Are Considered Critical Personnel By The Government: Veterinarian, Study Directors, Quality Assurance Officer, And Health And Safety Officer. the Principal Investigator Shall Be Responsible For The Performance Of The Work And The Deputy Principal Investigator Shall Act For The Contractor When The Principal Investigator Is Absent. The Principal Investigator And Deputy Principal Investigator Shall Have Full Authority On All Contract Matters Relating To Daily Operation Of This Contract. Evaluation Of Key And Critical Personnel Will Be Based On Education, Training, And Experience With Immunotoxicity Studies To Include But Not Be Limited To: experience With In Vitro Assessment Of Immune Function (innate, Humoral- And Cell-mediated Immunity) Using Primary Human Cells Or Other Relevant Cell Types. experience With In Chemico Skin Sensitization And In Vitro Skin Sensitization Or Other Alternative Methods Used In Immunotoxicity Screening. experience With Rodents, Health Assessments Of Rodents, And Toxicology Studies, Including Demonstrated Capability In The Conduct Of Studies In Laboratory Rodents To Evaluate Modulation Of Immune Function Following Exposure To A Test Compound. number And Variety Of Compounds Tested Using In Vitro And In Vivo Screening Methods As Well As Years Of Experience Testing These Compounds. demonstrated Experience In The Interpretation Of Immunotoxicity Data And Preparation Of Technical Reports. experience Of Personnel Working Together As A Team. the Contractor Shall Identify Appropriate Technical And Support Personnel To Conduct All Aspects Of The Studies, Including, But Not Limited To, Staff To Provide Animal Care/husbandry; Administer Test Articles To Rodents (including Pregnant Dams, Neonates/pups, Juvenile, And Adult Animals As Required) Via Required Route(s) Of Exposure (e.g., Dosed Feed Or Water, Oral Gavage, Intravenous Or Intraperitoneal Injection); Collect In-life Data (e.g., Body Weights, Clinical Observations, Food/water Consumption); And Technical Staff Proficient In Sterile And Other Laboratory Techniques For In Vitro Studies. the Principal Investigator, Deputy Principal Investigator, And Study Directors Shall Be Employees Of The Contractor (i.e., Not Consultants Or Subcontractors). Technical And Support Staff May Be Subcontractors (upon Approval By The Cor And Co), However, Performance Of All Work Must Occur At The Prime Contractor’s Facility. The Daily Interaction And Constant Coordination Of Efforts Needed To Conduct Multiple Tests With The Same Test Article Throughout The Studies Make It Critical That They Be Physically Together. contract Type And Contractor’s Accounting System: It Is Anticipated That The Resultant Contract Will Be A Cost Reimbursement Type Contract. Therefore, To Be Considered For An Award Under The Resultant Solicitation, The Offeror’s Accounting System And Practices Must Be Adequate And Suitable For Accumulating Costs Under Government Contracts. Offerors Will Be Required To Provide Evidence Of The Accounting System Being Adequate And The Proposal Shall Include A Certification That The Offeror’s Accounting System Meets All Of The Specifications Outlined In The Solicitation For An Adequate Accounting System, In Accordance With Far 16.301-3, 16.403-1, And In Compliance With Far Part 31. notice To Offerors **this Notice Is Not A Request For Proposals And Does Not Commit The Government To Award A Contract** a Solicitation May Or May Not Be Issued. The Issue Date Of The Solicitation Will Be No Sooner Than 15 Days From The Date Of This Notice. Proposals Will Be Due On Or About30 Days After The Solicitation Release Date. the Solicitation Is Anticipated To Result In One (1) Award To The Offeror Capable Of Performing All Aspects Of The Work Described In The Sow. This Contract Is Expected To Be A Cost-plus-fixed-fee Contract For Research And Development Services. It Is Anticipated That Award Will Be On Or Before September 2025 For A Base Period Of One-year, Plus Nine (9) Successive One-year Option Periods. The Proposed Contract Will Be A Small Business Set-aside. The North American Industry Classification System (naics) Code For This Procurement Is 541715 With A Corresponding Size Standard Of 1,000 Employees. The Government Intends To Make An Award Using The Procedures For Competitive Negotiated Acquisitions As Authorized In Far Part 15. the Solicitation Will Only Be Available Electronically And Must Be Accessed Through The Sam.gov Website (www.sam.gov). All Information Required For Submission Of A Proposal Will Be Contained In The Electronic Solicitation Package. It Is The Offeror’s Responsibility To Monitor The Above Website For The Release Of This Solicitation And Amendments, If Any. All Responsible Sources May Submit A Proposal, Which Shall Be Considered By The Agency. Proposals Must Be Submitted Through The Nih Electronic Contract Proposal Submission (ecps) System. Detailed Submission Instructions Will Be Provided Upon Issuance Of The Solicitation. All Questions Regarding This Acquisition Shall Be Submitted In Writing Via Email To: Adam.muhsin@nih.gov. Please Reference The Solicitation Number #75n96025r00001 And Project Title On Your Written Request. Telephone Inquiries Will Not Be Accepted.