DEFENSE HEALTH AGENCY DHA USA Tender

Request For Information (rfi) general Information document Type: Presolicitation Notice solicitation Number: Tbd posted Date: 11 October 2024 classification Code: Naics 541330 set Aside: N/a contracting Office Address: United States Army Medical Research Acquisition Activity (usamraa) - 808 Schreider Street, Fort Detrick, Md 21702 description this Is A Request For Information (rfi) Only – This Rfi Is Issued Solely For Information And Planning Purposes – It Does Not Constitute A Request For Proposal (rfp) Or A Promise To Issue An Rfp In The Future. Solicitations Are Not Available At This Time. Requests For A Solicitation Will Not Receive A Response. This Notice Does Not Constitute A Commitment By The United States Government To Contract For Any Supply Or Service Whatsoever. All Information Submitted In Response To This Announcement Is Voluntary; The United States Government Will Not Pay For Information Requested Nor Will It Compensate Any Respondent For Any Cost Incurred In Developing Information Provided To The United States Government. Not Responding To This Rfi Does Not Preclude Participation In Any Future Rfp, If Any Is Issued. usamraa Is Issuing This Rfi As A Means Of Conducting Market Research To Identify Parties Having An Interest In And The Resources To Support The Requirement Identified As Follows: requirement Description the Us Army Medical Research Institute Of Infectious Diseases (usamriid) Is Seeking A Company With Extensive Knowledge And Competence Providing Compliance Support On Select Agent And Biological Safety Regulatory Matters For The New Usamriid Building 8100. Usamriid Building 8100 Is A Federally Owned And Operated Biocontainment Facility Designed To House Biosafety Level 2 (bsl-2) Through Biosafety Level 4 (bsl-4) Work, Arthropod Containment At Bsl-2 (acl-2) And Bsl-3 (acl-3) And Small Animal Containment At Bsl-3 And Bsl-4 (absl-3/absl-4). contractors Associated With Personnel Services Within The Facility Should Fully Understand The Complexities Associated With Select Agent And Biosafety Requirements Associated With High And Maximum Containment Laboratory Facilities. The Facility Will Not Be Occupied During The First Year Of This Work As There Will Be On-going Construction To Complete The Design/build Of The Continuous Flow Effluent Decontamination System (eds), And Upgrades To The Building Automation System (bas) And Electronic Security System (ess). Follow On Years Will Have Partial Occupancy Starting With Administrative Spaces Followed By Bsl-2, Bsat Storage Only, Bsl-3/absl-3, Bsl-4/absl-4. Registration With The Centers For Disease Control And Prevention (cdc) Cannot Occur For Bsl-3/absl-4 & Bsl-4/absl-4 Until The Eds Design, Build And Functional Operation Testing Is Complete. the Contractor Will Serve As A Consultant To The Usamriid Building 8100 Transition Team On All Regulatory Matters Associated With Select Agent And Biological Safety Requirements To Obtain Full Cdc Registration And Building Occupancy. The Contractor Will Conduct A Gap Analysis For The Path To Registration With The Centers For Disease Control And Prevention (cdc) Based On Current Cdc Inspection Checklists, A Review Of Current Commissioning Documents, Assessments And Facility Inspections. Cdc Inspection Checklists Can Be Found Here: Preparing For Inspection | Compliance | Federal Select Agent Program (selectagents.gov). the Contractor’s Key Personnel Shall Have Extensive Knowledge And Competence In Select Agent Requirements And How Select Agent Regulations Relate To The Operation And Maintenance Of Systems Unique To Usamriid Building 8100 To Include (but Not Limited To) The Effluent Decontamination System (eds), Building Automation System (bas), Electronic Security System (ess), Test And Balance (tab) Requirements. Key Personnel Shall Have A Minimum Of 7-10 Years Of Experience Supporting A Bsl-4 Laboratory In The United States And 3-5 Years Of Experience Serving As An Ro Or Aro In A Fsap Registered Facility, Preferable Tier 1. Key Personnel Shall Have A M.s. Or Ph.d. In A Related Field Or Dvm. current Agencies Buying This Service Are The National Bio And Agro-defense Facility (nbaf) – Usda At 1980 Denison Ave., Manhattan, Ks. Https://www.usda.gov/nbaf. the Contractor Shall Include One (1) Week Onsite For Two (2) Individuals Each Month Of The Contract. Travel Can Also Be Adjusted To Allow For Two (2) Weeks Onsite (contiguous Or Disjunct) For One (1) Individual When Requested. Onsite Trips Consist Of Three (3) Onsite Days, Unless One Induvial Is Onsite For Two Continuous Week Which Allows For Eight (8) Onsite Days. Travel Expenses Will Be Billed At Cost, Including Actual Transportation Costs, Gsa-approved Meals And Incidental Per Diem Rates, And Gsa Lodging Rates (where Possible).   the Expected Breakdown Of Effort For The Listed Tasks: ro Regulatory Compliance Support Task – 40% rmo/bso Regulatory Compliance Support Task – 40% project Management – 20% 1. The Contractor Shall Work With Technical Point Of Contact Or Their Assigned Representative To Ensure Project Is Accomplished In A Timely Manner. 2. The Contractor’s Work Shall Adhere To The Criteria Stated Within These Project Requirements. All Services Shall Comply With Applicable Current Industry Standards, (i.e., Bmbl, Fsap Select Agent Regulations, Etc.), That Are In Effect When This Contract Is Awarded. 3. The Work Performed Under This Contract Shall Be Subject To Continuous Audit By The Cor/technical Poc. 4. Quality Control Is The Exclusive Responsibility Of The Contractor. 5. The Contractor Shall Ensure Their Onsite Support Staff Follow All Site Safety And Security Procedures And Policies. 6. The Government Shall Be Afforded 14 Calendar Day Review Periods For Submittals Requiring Approval And 7 Calendar Days For Information Only Submittals. 7. The Government Will Furnish Desk Space With Typical Office Space Amenities. A Government Furnished Laptop Will Be Provided. 8. This Is A New Requirement, And The Service Is Required Nlt 31 January 2025. The Contract Duration For This Project Is 365 Days From Notice To Proceed Issued By Contracting Officer. Four Option Years Is Anticipated Beyond The Base Year. 9. Travel For This Scope Of Work Would Include One (1) Week Onsite For Two (2) Individuals Each Month Of The Contract. Travel Can Also Be Adjusted To Allow For Two (2) Weeks Onsite (contiguous Or Disjunct) For One (1) Individual When Requested. Onsite Trips Consist Of Three (3) Onsite Days, Unless One Individual Is Onsite For Two Continuous Week Which Allows For Eight (8) Onsite Days. Travel Expenses Will Be Billed At Cost, Including Actual Transportation Costs, Gsa-approved Meals And Incidental Per Diem Rates, And Gsa Lodging Rates (where Possible). 10. Deliverable: The Contractor’s Team Onsite For Two Person Weeks Each Month. This May Be Split Into Two Trips Of One Week Each. Expected Delivery To Usamriid: Onsite Support Across All Tasks. general Information 1.0 Scope Of Work 1.1 Regulatory Compliance Support To The Ro/aro Task 1.1.1 Contractor’s Personnel Shall Work To Review Of The Current Select Agent Program And Training On New Regulatory Changes, Onsite Support And Planning, Assessing Gaps In Regulatory Compliance, Assisting Staff With Addressing Regulatory Gaps, Familiarizing Staff With The Select Agent Regulations, Development And Tracking Of Needed Regulatory Documentation, And Regulatory Inspection Preparation. The Schedule For All Activities Will Be Determined Upon Mutual Agreement Between The Contractor And Usamriid. 1.1.1.1 Deliverable: The Deliverables Under This Will Vary Due To The Constantly Evolving Nature Of This Support. Deliverables May Include Forms, Training Materials, Plan Reviews, Plan Revisions, Scheduling, Sops, Monthly Progress Updates, And Workflows. 1.1.1.2 Expected Delivery To Usamriid: Various Time Points Throughout The Period Of Performance (pop). Each Document Or Hard Deliverable Will Have A Set Turnaround Time As Decided Upon By Usamriid And At The Time That It Is Tasked. 1.2 Rmo/bso Support Task 1.2.1 Contractor’s Personnel Shall Provide Ongoing Technical Support To Usamriid’s Rmo/bso Group In The Form Of Document Generation, Reviews, And Gap Assessments. Additionally, The Contractor Will Offer Support In The Form Of Writing Sops And Workflows To Support Science Transition Activities. This Task Provides Flexibility To The Usamriid Enterprise For Support For Other Technical Or Related Tasks As Issues Arise Or New Challenges Develop. The Schedule And Timelines For All Activities Will Be Determined Upon Mutual Agreement Between The Contractor And Usamriid. 1.2.1.1 Deliverable: The Contractor Will Draft Manuals, Plans, Sops, And Workflows At The Direction Of The Rmo/bso Manager. Additional Support Can Also Be Provided As Defined By Usamriid. 1.2.1.2 Expected Delivery To Usamriid: The Deliverables Under This Task Will Vary Due To The Constantly Evolving Nature Of This Support. (note: Each Document Will Have A Set Turnaround Time As Decided Upon By The Rmo/bso Manager And The Contractor At The Time The Document Is Tasked To Contractor). 1.3 Project Management (pm) Task 1.3.1 Contractor’s Personnel Shall Provide Support Development Of Presentations Reporting On Task Progress For Usamriid As Associated With This Contract. 1.3.1.1 Deliverable: Monthly Progress Reports. 1.3.1.2 Expected Delivery To Usamriid: The Deliverables Under This Task Will Vary Due To The Constantly Evolving Nature Of This Support. the Information Obtained By This Request, Will Be Used Within Usamraa And Usamriid To Facilitate Decision Making And Will Not Be Disclosed Outside Of Usamraa Or Usamriid. If The Information Provided Contains Propriety Information, Such Information Must Be Identified With Appropriate Disclaimer. if Your Organization Has The Potential Capacity To Perform These Contract Services, Please Provide The Following Information: fill Out The Chart (organization Name, Address, Website Address, Size And Type Of Ownership For The Organization, Cage Code, Unity Entity Id (from Sam.gov)) And Point Of Contact Including Their Title, Telephone Number And Email Address; tailored Capability Statements Addressing The Particulars Of This Effort, With Appropriate Documentation To Support Claims Of Organizational And Staff Capability. If Significant Subcontracting Or Teaming Is Anticipated In Order To Deliver Technical Capability, Organizations Should Address The Administrative And Management Structure Of Such Arrangements. the Capability Statements Shall Address, At A Minimum, The Following Items: what Type Of Work Has Your Company Performed In The Past In Support Of The Same Or Similar Requirement? can Or Has Your Company Managed A Similar Task Of This Nature? If So, Please Provide Details. can Or Has Your Company Managed A Team Of Subcontractors Before? If So, Provide Details. what Specific Technical Skills Does Your Company Possess Which Ensure Capability To Successfully Fulfill This Requirement? the Government Will Evaluate Market Information To Ascertain Potential Market Capacity To: provide Supply / Services Consistent, In Scope And Scale, With Those Described In This Rfi And Otherwise Anticipated; secure And Apply The Full Range Of Corporate Financial, Human Capital, And Technical Resources Required To Successfully Perform Similar Requirements; additional Information And Submission Details fill In The Below Table And Include It With Your Submission: company Name company Address point Of Contact phone Number e-mail Address cage Code unique Entity Id company Web Page company Location(s) company Is / Is Not A Small Business company Is / Is Not System For Award Management (sam) Registered other Classifications (e.g. 8(a), Hubzone, Woman-owned, Veteran-owned, Service- Disabled Veteran-owned) if 8(a), Date That The Company Graduates From The Program. interested Parties Capable Of Providing The Requirements Described In This Rfi Are Requested To Submit A Capabilities Statement Of No More Than Ten (10) Pages In Length In Times New Roman Font Of No Less Than 10 Pitch. All Submissions Shall Be Submitted In Either Microsoft Word Or Portable Document Format (pdf). responding To This Request With Generic Material Only Such As Brochures, Advertisements Or Other Generic Material Is Highly Discouraged. Vendors Are Encouraged To Provide Questions Regarding Any Ambiguities Noted Within The Requirement Description. the Government Welcomes Input And Will Accept Questions Pertaining To This Rfi; However, The Government Reserves The Right To Answer Or Not To Answer All Questions Received. Questions Pertaining To This Rfi Are Due By 1300 Et On 22 October 2024. Only One Set Of Questions Per Vendor Will Be Accepted. Contact With Government Personnel, Other Than Those Specified In This Request, By Potential Vendors Or Their Employee’s Regarding This Requirement Is Not Permitted. all Responses To This Rfi Must Be Provided Via Email No Later Than (nlt) 1300 Eastern Time On 30 October 2024 To Mrs. Tonya Kreps Via Email At Tonya.r.kreps.civ@health.mil. No Extensions Will Be Granted. end Of Rfi