National Institutes Of Health Tender

Notice Of Intent To Sole Source 1.solicitation Number:75n95024q00317 2. Title: Understanding Cannabis Use And Prep Adherence In Black Sexual & Gender Minorities 3. Classification Code:b537 – Special Studies/analysis - Medical And Health Studie 4. Naics Code:621498 All Other Outpatient Care Centers 5. Response Date:august 17, 2024 At 1:00 Pm Est 6. Primary Point Of Contact: shaun Rostad shaun.rostad@nih.gov phone: (301) 443-6677 7. Description: introduction this Is A Pre-solicitation Non-competitive (notice Of Intent) Synopsis To Award A Contract Without Providing For Full Or Open Competition (including Brand-name). the National Institute On Drug Abuse (nida), Office Of Acquisitions Intends To Solicit By A Request For Quotation From The University Of Maryland For Award On Or Around August 20, 2024. The Purpose Of This Acquisition Will Be To Provide The National Institute On Drug Abuse (nida) With The Collection Of Passive Digital Phenotype Data, Self-reports Via Surveys And Daily Diaries; And Biological And Clinical Records Data From Patients Via Health Clinics Or Institutes With Access To The Patient Populations And The Infrastructure To Perform A Research Study Of Digital Phenotyping Gender And Sexual Minority (gsm) Patients Who Use Cannabis, Oversampling Black Gsm. north American Industry Classification System (naics) Code And Set Aside Status the Intended Procurement Is Classified Under Naics Code 621498 With A Size Standard Of $25.5 Million. this Acquisition Is Not Set Aside For Small Businesses. regulatory Authority this Acquisition Is Conducted Under The Authority Of The Federal Acquisition Regulation (far) 13.5—simplified Procedures For Certain Commercial Products And Commercial Services. Contracts Awarded Using Far Part 13—simplified Acquisition Procedures Are Exempt From The Requirements Of Far Part 6—competition Requirements. Far Subpart 13.106-1 (b) Soliciting From A Single Source Provides That: For Purchases Not Exceeding The Simplified Acquisition Threshold, Contracting Officers May Solicit From One Source If The Contracting Officer Determines That The Circumstances Of The Contract Action Deem Only One Source Reasonably Available (e.g., Urgency, Exclusive Licensing Agreements, Brand-name Or Industrial Mobilization). the Resultant Contract Will Include All Applicable Provisions And Clauses In Effect Through The Federal Acquisition Circular (fac) 2024-06, Dated 07-30-2024. description Of Requirement Purpose And Objectives: sexualized Cannabis Use, Or The Consumption Of Cannabis Surrounding And During Sexual Encounters, May Significantly Influence Hiv Transmission Rates By Increasing Instances Of Condomless Anal Sex And The Number Of Sexual Partners. While Hiv Pre-exposure Prophylaxis (prep) Has Shown Efficacy Rates Nearing 99% In Adherent Individuals, Adherence, Especially Among Black Sexual Minorities And Gender Minorities, Remains Notably Understudied In The Context Of Cannabis Use. This Project Aims To Understand The Complex Relationship Between Cannabis Consumption, Hiv Transmission Risk, And Prep Outcomes, With A Primary Focus On Black Sexual Minorities And Gender Minorities But Also Encompassing All Individuals Assigned Male At Birth Who Engage In Sex With Men, Regardless Of Their Hiv Status. The Inclusion Of A Broader Demographic Allows For A Comparative Analysis Between Racial Groups, Shedding Light On Potential Disparities And Similarities In Behaviors And Outcomes. Given The Rise In Cannabis Use And The Advent Of Geosocial Networking Apps Catering To Cannabis Users, There's A Speculated Link Between Sexualized Cannabis Use And Increased Hiv Transmission Risks. A Custom Smartphone App Will Be Utilized To Passively Collect Diverse Digital Data, From Gps Locations To Social Media Interactions, Complemented By Smart-context Aware Ecological Momentary Assessments. Artificial Intelligence Will Be Employed To Develop And Validate Prep And Hiv Risk Prediction Algorithms, Drawing From The Rich Digital Phenotype Data That Includes Demographics, Mood, Sexual Behavior, Social Support, Dating Behavior, Substance Use, And Location. Advanced Computational Algorithms Will Be Harnessed To Predict Cannabis Use And Cravings, Emphasizing The Identification Of Pivotal Features That Classify Cannabis Cravings And Use In The Context Of Sexual Behavior. Additionally, This Project Will Probe Into The Associations Between The Systemic Challenges Faced By Black Sexual And Gender Minorities, Such As Stigma, Discrimination, And Mental Health Issues, And Their Connections To Biological Inflammation, High-risk Sexual Behaviors, And Hiv Seroconversion, Utilizing Digital Phenotyping, Event-level Measures, Innovative Cannabis Consumption Metrics, And Objective Biomarker Data. project Requirements: contractor Must Meet The Following Requirements: 1. Recruitment And Study Enrollment contractor Must Have The Ability To Access And Recruit 200 Participants To Complete This 45-day Study. Participants Populations Must Be A Gsm Who Uses Cannabis; 80% Of The Sample Will Be Black Gsm. contractor Must Have Direct Experience Conducting Research With Our Target Population To Support Participant Recruitment And Enrollment Objectives. engage With A Contractor That Has Partnerships With Health Clinics In Maryland And Dc Metro Area, That Provide Healthcare To Our Target Populations, So That We Can Leverage Access To These Clinics To Recruit Individuals With A Substance Use Disorder And Sexual Minority Men And Gender Minorities. obtain All Regulatory Approvals Necessary To Conduct The Research. collaborate With A Contractor To Identify Potential Participants Who Meet The Study's Eligibility Criteria. screen And Obtain Informed Consent From Participants In Accordance With The Study Protocol. ensure Completion Of Enrollment Procedures. track Participants Throughout The Study To Ensure Compliance And Conduct Follow-up Outreach To Retain Participants And Encourage Study Completion. 2. Provide Remuneration contractor Must Have The Experience And Ability To Provide A Variety Of Remuneration Support To Participants As Compensation For Time And Effort To Participate In The Study. 3. Collaboration And Communication contractor Must Have The Experience And Ability To Manage Regular Communication And Collaboration Between The Government Through Meetings, Progress Updates, And Consultations Will Be Scheduled As Needed To Ensure Effective Coordination And Exchange Of Information. 4. Medical Care And Prep Provision contractor Must Identify Established Partnerships With Clinics And Programs To Provide Necessary Medical Care To The Study Participants. They Must Ensure That Prep Services, Including Prescription And Monitoring, Are Provided To Eligible Participants. Vendors Must Be Able To Coordinate With The Health Clinics To Facilitate The Integration Of Prep Services Into The Participants' Care Plans. Contractor Must Also Be Able To Collaborate With Participating Centers To Obtain Relevant Medical Records, Drug Screens, And Clinical Information Related To Participants' Prep Utilization And Adherence; Drug Treatment Adherence; And Other Related Care. 5. Data Collection And Monitoring contractor Must Have The Experience And Ability To Assist Participants In Installing An Android Smartphone Application For Data Collection, Passive Mobile Data Monitoring, And Ecological Momentary Assessments, As Outlined In Study Protocol. Vendors Must Be Able To Collaborate With Nida-irp To Ensure Seamless Integration Of The Smartphone Application With The Services Provided By Partnering Health Clinics. Ensure Patient Confidentiality In Recordkeeping And Monitor And Promote The Collection Of Passive Data From Participants Using The Smartphone Application For The Duration Of The Study. Contractor Must Be Able To Monitor And Promote The Collection Of Self-report Surveys And Daily Diaries To Collect Additional Data On Cannabis Use And Risky Sexual Behaviors, As Well As Collect And Maintain Clinical Data For Study Duration Including Provide Clinical Data To Nida-irp Researchers. 6. Reporting contractor Must Have The Experience In Preparing All Regulatory Documents To Gain Necessary Approvals. Contractor Must Have Experience With Providing Regular Updates (e.g. Recruitment Status), Ad Hoc Status Reports, And Managing De-identified Study Data At The End Of The Project. Contractor Must Have The Experience And The Ability To Oversee The Recruitment, Enrollment, And Follow-up Procedures With Participants On Similar Studies. The Contractor Must Have The Experience And Ability To Protect All Sensitive Protected Health Information (phi) Or Personally Identifiable Information (pii) Collected While Performing The Required Services. 7. Capable Vendor Site Specifications contractor Must Have The Expertise In Conducting Research Trials Involving Hiv Management And Prevention And Substance Use Disorder Treatment. Contractor Must Possess An Established Infrastructure To Recruit The Required Number Of Research Participants And Provide Hiv Care For People Living With Hiv And Preventing Hiv In Individuals Seeking This Care. contracting Without Providing For Full Or Open Competition (including Brand-name) Determination the Determination By The Government To Award A Contract Without Providing For Full And Open Competition Is Based Upon The Market Research Conducted. Specifically, The University Of Maryland Is The Only Vendor In The Marketplace That Can Provide The Services Required By Nida. in Accordance With Far Part 10, Extensive Market Research Was Conducted To Reach This Determination. Specifically, Contacts With Knowledgeable Individuals Both In Industry And Government, As Well As Reviews Of Available Product Literature, Revealed No Other Sources. Finally, A Review Of The Gsa Advantage, Dynamic Small Business Search, Andprevious Government Acquisitions Returned No Results That Meet All Of The Requirements. Therefore, Only The University Of Maryland Is Capable Of Meeting The Needs Of This Requirement. the Intended Source Is: university Of Maryland School Of Medicine 655 W. Baltimore Street baltimore Md 21201 closing Statement this Synopsis Is Not A Request For Competitive Proposals. However,interested Parties May Identify Their Interest And Capability To Respond To This Notice. a Determination By The Government Not To Compete This Proposed Contract Based Upon Responses To This Notice Is Solely Within The Discretion Of The Government. All Responsible Sources May Submit A Capability Statement, Proposal, Or Quotation Which Shall Be Considered By The Agency. The Information Received Will Normally Be Considered Solely For The Purposes Of Determining Whether To Proceed On A Non-competitive Basis Or To Conduct A Competitive Procurement. responses To This Notice Shall Contain Sufficient Information To Establish The Interested Parties’ Bona-fide Capabilities For Fulfilling The Requirement And Include: Unit Price, List Price, Shipping And Handling Costs, The Delivery Period After Contract Award, The Prompt Payment Discount Terms, The F.o.b. Point (destination Or Origin), The Unique Entity Identifier (uei), The Taxpayer Identification Number (tin), And The Certification Of Business Size. All Offerors Must Have An Active Registration In The System For Award Management (sam) Www.sam.gov. Far Clauses 52.212-4, Contract Terms And Conditions – Commercial Items And 52.212-5 Contract Terms And Conditions Required To Implement Statutes Or Executive Orders – Commercial Items Apply To This Acquisition. all Responses Must Be Received By The Closing Date And Time Of This Announcement And Must Reference The Solicitation Number, 75n95024q00317. Responses Must Be Submitted Electronically To Shaun Rostad, Contract Specialist, At Shaun.rostad@nih.gov U.s. Mail And Fax Responses Will Not Be Accepted.