Data Center Tenders
Data Center Tenders
PROVINCE OF ZAMBOANGA DEL NORTE Tender
Philippines
Details: Description Republic Of The Philippines Province Of Zamboanga Del Norte Bids And Awards Committee Provincial Capitol, Estaka, Dipolog City Email Add: Bidsandawards22@gmail.com November 20, 2024 Invitation To Bid The Provincial Government Of Zamboanga Del Norte Through The Bids And Awards Committee (bac) Is Inviting Interested Parties/ Bidders To Bid For The Following Contract: Contract Id: Pr#300(01)24-11-453(o) & 300(01)24-11-424(o) Contract Name: Procurement Of General Merchandise (hardware, Electrical, Construction Supplies And Safety & Occupational Products) Location/purpose: For The Use In The Construction Of Disaster Recovery Data Center, Roof Deck, Provincial Library, Estaka, Zamboanga Del Norte. Approved Budget For The Contract (abc): Pr#300(01)24-11-453(o) - P 278,809.50 Pr#200(01)24-11-424(o) - 14,376.00 Grand Total P 293,185.50 (inclusive Of All Applicable Taxes) Bidders/ Contractors Must Have An Expertise In Undertaking A Similar Project, Completed At Least Two Similar Contracts Which The Equivalent Amount Is At Least 25% Of The Proposed Project For Bidding Within The Last Three Years. Bidders Are Inform That The Delivery Term Is 30 Calendar Days Upon Receipt Of Notice To Proceed. Bidders/ Contractors Shall Submit Their One (1) Copy Sealed Envelope Containing Their Technical And Financial Documents Documents Submitted Must Be In Accordance With The Checklist Provided And Must Have A Corresponding Label Or Name Plates. The Eligibility Check/ Screening As Well As The Preliminary Examination Of Bids Shall Use The Non- Discretionary "pass/ Fail" Criteria. Post Qualification Of The Lowest/ Single Bids Shall Be Conducted. All Particulars Relative To Eligibility Statement And Screening, Bid Security, Performance Security, Evaluation Of Bids, Post Qualification And Award Of The Contract Shall Be Governed By The Pertinent Provision Of Ra 9184 And Its Implementing Rules And Regulations (irr). All Bids Must Be Accompanied By A Bid Security In Any Of The Acceptable Forms In The Amount Stated In Itb Clause 14. Bidding Is Restricted To Filipino Citizens/ Sole Proprietorships, Partnerships Or Organizations With At Least Sixty Percent (60%) Interest Or Outstanding Capital Stock Belonging To Citizens Of The Philippines, And To Citizens Or Organizations Of A Country The Laws Or Regulations Of Which Grant Similar Rights Or Privileges To Filipino Citizens, Pursuant To Ra No. 5183. The Schedules Of Activities Are Listed As Follows: Bac Activities Schedule Advertisement / Posting November 21 - 27, 2024 Availability And Issuance Of Bidding Documents November 21 - 28, 2024 @ 08:30am Deadline For The Submission Of Bids November 28, 2024 @ 08:30 Am Bid Opening And Evaluation November 28, 2024 @ 09:00am Payment For Bidding Documents Is A Non- Refundable Amount Of Five Hundred Pesos Only (php500.00) Payable To The Office Of The Provincial Treasurer, Provincial Capitol Building, Dipolog City. Prospective Bidders May Obtain Further Information From The Office Of The Bids And Awards Committee, Provincial Capitol Building During Office Hours @ 8:00am - 5:00pm. Bids Must Be Duly Received By The Bac Secretariat Through Manual Submission At The Address Stated Above. The Provincial Government Of Zamboanga Del Norte Reserves The Right To Reject Any And All Bids, Declare A Failure Of Bidding, Or Not Award The Contract At Any Time Prior To Contract Award In Accordance With Sections 35.6 And 41 Of The 2016 Revised Irr Of Ra No. 9184, Without Thereby Incurring Any Liability To The Affected Bidder Or Bidders. Bidding Documents Will Be Electronically Uploaded To The Philgeps Website Of The Provincial Office Of Zamboanga Del Norte At Bidsandawards22@gmail.com. Atty. Rafael R. Osabel, Jr. Bac Chairman Annex A: Procurement Of General Merchandise (hardware, Electrical, Construction Supplies And Safety & Occupational Products) Pr#300(01)24-11-453(o) Abc: P278,809.50 1. 94 Bags Portland Cement 2. 166.67 Bdft Coco Lumber 2” X 2” X 10’ (50 Pcs) 3. 200 Bdft Coco Lumber 2” X 3” X 10’ (40 Pcs) 4. 40 Pcs Ordinary Plywood 1/2” 5. 117 Pcs 10mm Dia Dsb – 117 Pcs 6. 76 Pcs 12mm Dia Dsb – 76 Pcs 7. 12.50 Kgs No.16 Galvanized Iron Wire 8. 15 Bags Water Proofing 9. 10 Kgs Cwn #4” 10. 8 Kgs Cwn #3” 11. 5 Kgs Cwn #1-1/2” 12. 2 Set Pre-fab Glass Door (0.90m X 2.10m, 1/4 Clear Glass With Complete Accessories Including Jamb) 13. 3 Gal Concrete Neutralizer 14. 5 Gal Concrete Sealer 15. 6 Gal Patching Compound 16. 5.0 Gal Flat Latex 17. 5 Gal Semi Gloss Latex 18. 2 Pcs Mini Roller Brush 4” 19. 2 Pcs Paint Brush 4” 20. 10 Pcs Sand Paper #120 21. 10 Pcs Sand Paper #80 22. 7 Pc Junction Box 23. 1 Pc Upvc Pull Box 24. 1 Pc Entrance Cap 2” 25. 1 Pc Male Adaptor 2’ 26. 3 Sets Two Gang Outlet Flush Type 27. 4 Pc Plastic Receptacle 4” 28. 1 Set Three Gang Switch Flush Type 29. 4 Pc Switch Box 30. 50 Mtrs 30mm2thhn Wire Stranded 31. 5 Length Upvc Pipe Thickwall 2” 32. 3 Mtr Hardware Cloth 33. 20 Mtrs 5.5mm2 Thhn Wire Stranded 34. 35 Mtrs 3.5mm2 Thhn Wire Stranded 35. 45 Mtrs 2.0mm2 Thhn Wire Stranded 36. 10 Length Upvc Pipe Thickwall ½” 37. 15 Length Plastic Moulding ¾” 38. 5 Length Upvc Pipe Thickwall 3/4” 39. 5 Pack No More Nails 40. 3 Roll Electrical Tape 3m 41. 45 Mtrs 8.0mm2 Thhn Wire Stranded 42. 40 Mtrs 14mm2 Thhn Wire Stranded 43. 2 Set 40 Amp Safety Breaker Nea 3r 44. 2 Set Led Bulb 20w 45. 1 Set Led Bulb 18w 46. 1 Set Circuit Panel Board With 6 Branches, Tqd, Bolt-on Type Main: 125 Amp. Bolt-on Type Branches : 2 – 70 A Bolt On Type 2 – 40 A Bolt On Type 1 – 20 A Bolt On Type 1 – 15 A Bolt On Type Sub-total: P278,809.50 Pr#300(01)24-11-424(o) Abc: P14,376.00 1. 1 L.s First Aid Kit 2. 4 Pc Safety Helmet 3. 4 Pair Safety Shoes 4. 4 Pc Safety Vest 5. 4 Pair Working Gloves 6. 4 Pair Safety Boots Sub-total: P14,376.00 Grand Total: P293,185.50 ***nothing Follows***
Closing Soon28 Nov 2024
Tender AmountPHP 293.1 K (USD 4.9 K)
DEPT OF THE NAVY USA Tender
Civil And Construction...+1Others
United States
Details: The Work For This Project Includes, But Is Not Limited To, The Construction Of A Multi-story Communications Center Facility To Support Naval Computer And Telecommunications Station Guam Operations. Special Features Include Sensitive Compartmented Information Facility Construction Work In Accordance With Icd/ics 705 And Demolition And Incidental Related Work. Secure Facility Construction Shall Be Performed By U.s. Companies Using U.s. Citizens.
the Work Will Also Include Three (3) Pre-priced Options For The Construction Of Two (2) Single-story Warehouse Facilities, And Osp Fiber Line Sonet Ring. In Accordance With Far 52.217-7 Option For Increased Quantity – Separately Priced Line Item, The Government May Exercise The Options By Written Notice To The Contractor Within 365 Days Of Contract Award.
the Magnitude Of This Project Is Estimated Between $250,000,000 And $500,000,000. The North American Industry Classification System (naics) Code Is 236220 And Average Annual Receipts Of $45 Million Over The Past Three Years. The Contract Completion Period Is Anticipated To Be 1,255 Calendar Days.
a Sources Sought Notice (n62742sscomms) For This Procurement Was Posted On 22 August 2023 On The System For Award Management (sam) Website Https://www.sam.gov/, And A Market Survey Was Conducted That Included An Assessment Of Relevant Qualifications And Capabilities Of Potentially Qualified Firms. As A Result Of The Market Research Analysis, A Determination Was Made To Solicit This Procurement On An Unrestricted Basis Inviting Full And Open Competition.
this Solicitation Will Utilize The Tradeoff Source Selection Process. All Technical Factors, When Combined, Are Considered Of Equal Importance To Past Performance. The Factors Are: Factor 1 – Experience, Factor 2 – Safety, Factor 3 – Small Business Utilization And Participation, Factor 4 – Past Performance, And Price. Contract Award Will Be Made To The Offeror Proposing The Best Value To The Government From A Non-price And Price Standpoint. Furthermore, A Relevant Construction Project Is Defined As A Construction Project That Includes At Least One Of The Following Individual Features:
(1) Precision Cooling System. New Construction Of A Chiller Type Technology Cooling System Engineered Specifically For Data Center/electronic/it Networking Environments. Projects Submitted Which Reference Comfort Cooling Systems Which Are Engineered Primarily For The Intermittent Use Required To Maintain A Comfortable Environment For People In Facilities Will Not Be Considered. Projects Submitted To Demonstrate Precision Cooling System Will Only Be Considered If The Work Was Performed By The Specific Entity Proposed For The Precision Cooling System Under The Resultant Contract, As Identified In Block 1 Of Attachment A.
(2) Uninterruptable Power Supply System. New Construction Of An Uninterruptible Power Supply (ups) System That Is 225 Kva Size Or More. Projects Submitted To Demonstrate Ups System Experience Will Only Be Considered If The Work Was Performed By The Specific Entity Proposed For The Ups System, As Identified In Block 1 Of Attachment A.
(3) Clean Agent Fire Suppression System. New Construction Or Replacement Of A Clean Agent Fire Extinguishing System And Releasing System, Including All Mechanical, Controls And Electrical Components Necessary For A Complete And Operating Clean Agent Fire Suppression System. Projects Submitted To Demonstrate Clean Agent Fire Suppression System Experience Will Only Be Considered If The Work Was Performed By The Specific Entity Proposed For The Clean Agent Fire Suppression System, As Identified In Block 1 Of Attachment A.
see Request For Proposal (rfp) Document 00 21 16.
the Rfp, Including The Specifications And Drawings, Can Be Accessed By Approved Individuals Via The Sam Website At Https://sam.gov/. Approved Individuals Must Register At The Sam Website To Obtain Access To The Rfp. Registration Instructions Can Be Found On The Sam Website. Once Registered In Sam, Approved Individuals Must Request Explicit Access To View The Documents. An Email Will Be Forwarded Once The Contracting Office Has Approved Or Declined The Request. Approved Individuals May View And/or Download The Rfp Documents. Amendments Will Also Be Posted At Https://sam.gov/. It Is Highly Recommended That Firms Register On The Sam Website As This Will Be The Only Plan Holder’s List Available. It Is The Offeror’s Responsibility To Check The Sam Website Periodically For Any Amendments To The Solicitation.
offerors Are Required To Be Registered In The Sam Database At Https://www.sam.gov At The Time Of Proposal Submission.
see Document 00 21 16 For Pre-proposal Site Visit Information. This Site Visit Is To Provide Offerors With An Opportunity To Familiarize Themselves With The Jobsite And Conditions To Be Encountered And Is Not For The Purpose Of Answering Questions. Forms Submission To Ms. Merbby Corpuz At Merbbyjoyce.n.corpuz.civ@us.navy.mil On Or Before 31 October 2024, 2:00 P.m., Hawaii Standard Time (hst).
(1) Current Dbids. If An Interested Attendee Has Current Dbids Credentials For The Specific Base Where The Project Is Located, Submit The Following:
company Letter Template: One Letter Required Per Company. List Attendees In Alphabetical Order (by Last Name). Must Be Signed By A Person Authorized To Provide The Certification Required.
request For Camera Pass Form: Applicable Only For Those With Dbids Credentials Who Will Be Taking Photos. One Letter Required Per Company. Dbids Number Is Required On The Form. Once Properly Submitted To The Poc In Subparagraph (c) Above And Once Approved, You Will Receive A Routing Number From The Poc. An Appointment With The Naval Base Guam (nbg) Visitor’s Control Center (vcc) Is Required To Complete The Processing Of Your Camera Pass.
(2) Current Dbids Not For The Specific Base Where The Project Is Located. Submit The Following:
company Letterhead Template: One Letter Required Per Company. List Attendees In Alphabetical Order (by Last Name). Must Be Signed By A Person Authorized To Provide The Certification Required.
dbids Base Access Request Form: Each Attendee Please Read, Complete, And Sign/date. Typewritten Is Preferred. Any Handwritten Forms Must Be Legible.
email The Vcc At M-gu-nbg-n3at-vcc@fe.navy.mil To Have Their Dbids Programmed With The Specific Base Where The Project Is Located. Prior To Emailing The Vcc, Please Submit The Company Letter And The Dbids Base Access Request Form To The Poc In Subparagraph (c) Above For Approval. Once Approved, The Documents Will Be Sent Back To You For Submission To The Ngb Vcc Along With The Request To Have The Dbids Cards Programmed With The Specific Base Where The Project Is Located.
request For Camera Pass Form: Applicable Only For Those With Dbids Credentials Who Will Be Taking Photos. One Letter Required Per Company. Dbids Number Is Required On The Form. Once Properly Submitted To The Poc In Subparagraph (c) Above And Once Approved, You Will Receive A Routing Number From The Poc. An Appointment With The Naval Base Guam (nbg) Visitor’s Control Center (vcc) Is Required To Complete The Processing Of Your Camera Pass.
(2) No Dbids Credentials. Submit The Following:
company Letterhead Template: One Letter Required Per Company. List Attendees In Alphabetical Order (by Last Name). Must Be Signed By A Person Authorized To Provide The Certification Required.
secnav 5512/1 Form: Each Attendee Shall Read, Complete, And Sign/date Form. Typewritten Is Preferred. Any Handwritten Forms Must Be Legible. Do Not Submit The Secnav 5512/1 Form To The Government. The Contractor Is Responsible For Either Hand-carrying Or Emailing This Document To The Ngb Vcc Along With Any Other Pertinent Document Listed In This Subparagraph.
dbids Base Access Request Form: Each Attendee Please Read, Complete, And Sign/date. Typewritten Is Preferred. Any Handwritten Forms Must Be Legible.
naval Base Guam Foreign National Base Access Request Form (applicable To Foreign Nationals Only). Each Attendee Please Read And Complete.
fn Biometric Data Form (applicable To Foreign Nationals Only): Each Attendee Please Read And Complete.
request For Camera Pass Form: Applicable Only For Those With Dbids Credentials Who Will Be Taking Photos. One Letter Required Per Company. Once You Have A Routing Number From The Vcc For Your Dbids Application, Insert That Number On The Form. Once Properly Submitted To The Poc In Subparagraph (c) Above And Once Approved, You Will Receive A Routing Number From The Poc. An Appointment With The Naval Base Guam (nbg) Visitor’s Control Center (vcc) Is Required To Complete The Processing Of Your Camera Pass.
Closing Date29 Jan 2025
Tender AmountRefer Documents
Offizielle Bezeichnung Magistrat Der Stadt Schwalbach Am Taunus Tender
Civil And Construction...+1Civil Works Others
Germany
Description: Public tender (service) City of Schwalbach am Taunus - Market research into the continued operation of the district heating plant Market research The city of Schwalbach am Taunus wants to use this market research to determine whether heat supply companies are interested in continuing to operate the district heating plant in Schwalbach am Taunus, including the obligation to undertake the necessary transformation and investment measures as well as to provide a heating network. The city of Schwalbach am Taunus is calling on potential supply companies to express their interest in taking over the district heating plant. To this end, the utility company expressing interest must submit a binding and detailed project and timetable showing how it intends to ensure the continuity and future viability of a socially fair heat supply in Schwalbach am Taunus. This includes in particular: - Description of the provision of the heating network: The measures must be designed in such a way that investments begin immediately and that all customers are connected by December 31, 2027. - Description of the planned transformation projects: The planned transformation projects must be designed in such a way that investments start within a period of 12 months and are implemented within a period of three years. It must also be shown how the share of renewable district heating generation and waste heat utilization can be increased to 50 percent by 2030 without this leading to an unreasonable disadvantage for customers (e.g. through the use of two data centers 1.5 km from the heating plant). - Description of an appropriate price level: On the basis of an appropriate business plan, it must be ensured that the district heating prices are appropriate and in line with the national average. In addition, pricing and the price model offered to customers as well as measures to ensure the transparency of price increases must be presented. - Expansion of the heating network in the direction of Alt-schwalbach - Concept for the modernization of the transfer stations (including assistance for customers) -- Market research The town of Schwalbach am Taunus is the owner of the property, registered with the Königstein im Taunus district court, Schwalbach land register, sheet 3852, current no. No. 4: Schwalbach district, plot 47, plot 53/4, courtyard and building area, Adolf-Damaschke-Strasse, 3,361 m². A district heating plant is operated on this property on the basis of a leasehold. The corresponding leasehold contract expires on December 31, 2027. The city of Schwalbach am Taunus is considering granting a corresponding leasehold for the property again with a term of at least 10 to 20 years to a reliable and suitable utility company that offers the guarantee of ensuring the heat supply to the connected customers in a sustainable manner. For more details, see the document on market research. -- This announcement is solely a call for market research. The city of Schwalbach am Taunus has no procurement or other binding intentions. Participation in the market research is voluntary and free of charge. The results of the market research will help the town of Schwalbach am Taunus to determine the future organizational structure for the continued operation of the district heating plant.
Closing Date2 Dec 2024
Tender AmountRefer Documents
NDCon LOGIC A s Tender
Others...+1Civil And Architectural Services
Corrigendum : Closing Date Modified
Czech Republic
Details: The subject of the Public Contract is the creation of a Digital Twin (data center). The structure of the operated system in the data center requires ensuring high availability and a level of security according to the Act on Cyber Security and Related Legislative Standards for the Operation of Information Infrastructure and Information Systems. The detailed specification of the subject and the conditions of performance are given in Appendix No. 4 of the tender documentation "technical specification" and also in Appendix No. 3 of the tender documentation "draft contract for the work", which are electronically unlimitedly available on the client's profile.
Closing Soon21 Nov 2024
Tender AmountCZK 19.3 Million (USD 805.2 K)
Offizielle Bezeichnung Tender
Civil And Construction...+1Others
Germany
Description: Contract notice – general guideline, standard regulation negotiated procedure with prior publication of a call for competition/negotiated procedure (services) Pei_bnb-ko The Paul Ehrlich Institute can only maintain operations at its current location in Langen at increased expense and does not have the necessary future-proof flexibility or the urgently needed expansion space on the property. A new research campus is therefore to be built on a nearby plot of land. Certification for the system variants Bnb laboratory building - new construction (bnb_ln) and outdoor facilities of federal properties (bnb_aa) is planned for the new building. The construction project is to achieve an overall fulfillment level of at least 65% (silver level) in each of the system variants. The parking garage, which is planned as a separate building, is also intended to achieve an overall fulfillment level of at least 65% (silver level) as part of an appropriate BNB application. For this, services for management, coordination and documentation in accordance with the Sustainable Construction Assessment System are required for the new building of the Paul Ehrlich Institute in Langen. Pei_bnb-ko The Federal Republic of Germany is planning to relocate the Paul Ehrlich Institute (PEI) on a plot of land opposite the currently used site in Langen. This major project is being carried out by the State Office for Construction and Real Estate in Hesse (LBih) on behalf of the Federal Agency for Real Estate (BIMA). The user and operator is the Paul Ehrlich Institute. Certification for the system variants BNB laboratory building - new construction (BNB_LN) and outdoor facilities of federal properties (BNB_AA) is planned for the new building. The construction project in each system variant is intended to achieve an overall fulfillment level of at least. 65% (silver level). The parking garage, which is planned as a separate building, should also achieve an overall level of fulfillment of at least 65% (silver level) as part of an appropriate BNB application. The subject of this negotiation procedure is the management, coordination and documentation according to the Sustainable Construction Assessment System [BNB] of the new building project Paul Ehrlich Institute in Langen. For the new building of the PEI, an integrated project management (IPA) based on a multi-party contract (MPV) is planned. The multi-party contract is designed so that the contract partners pursue project success as a common goal on the basis of common project principles and in close partnership. The BNB coordination is not a partner in the multi-party contract, but is integrated into the IPA team as a subcontractor of the LBih. The BNB coordination will work particularly in the project implementation teams using lean methods in close coordination with the other project participants across all MPV phases. The new building of the Paul Ehrlich Institute includes a public area with a foyer, a conference area including a lecture hall and a library, as well as several non-public areas with the operation of microbiological, medical diagnostic and biotechnical safety laboratories as well as genetic engineering facilities. Furthermore, the non-public areas house offices, data centers, the central operating technology and a supply and disposal area. In combination with the aforementioned partnership-based project management form, lean construction methods will also be used. Furthermore, the use of Building Information Modeling (BIM), which has become mandatory for the building administration as a consequence of the "BIM master plan for federal buildings" introduced by decree, is intended to achieve further synergies and to optimally promote the planning and construction process right up to the handover to the company. Last but not least, a virtual project room is being set up as a common data environment for this purpose, the Common Data Environment (CDE), which includes a project communication management system (PKMS) in addition to the original functions of a CDE. The subject of the services advertised in this tender procedure is the provision of management, coordination and documentation services in the sense of quality assurance for the client as well as evidence for the BNB certification of the new buildings/outdoor facilities or the appropriate application of sustainable construction on the new property of the Paul Ehrlich Institute. The detailed requirements and tasks can be found in the service description. The client envisages a step-by-step commissioning based on the phases of the multi-party contract in accordance with the provisions of the underlying contract.
Closing Date9 Dec 2024
Tender AmountRefer Documents
National Institutes Of Health Tender
Others...+1Building Construction
United States
Details: The National Institute Of Diabetes And Digestive And Kidney Diseases (niddk) Seeks Industry Partners For Clinical Research Collaborations On Therapeutics, Diagnostics Or Devices For Childhood Cholestatic Liver Diseases
the National Institute Of Diabetes And Digestive And Kidney Diseases (niddk) Of The National Institutes Of Health (nih) Of The Department Of Health And Human Services (dhhs) Seeks Industry Collaborators To Provide Novel Therapeutic Agents, Diagnostic Markers, Biomarkers And Devices For Use In Nih-sponsored Multi-center Clinical Trials And Ancillary Studies In Patients With Childhood Cholestatic Liver Diseases, Including Biliary Atresia, Alpha-one Antitrypsin Deficiency, Cystic Fibrosis Liver Disease, Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis (pfic), Bile Acid Synthesis Defects, Mitochondrial Respiratory Chain And Fatty Acid Oxidation Defects, Primary Sclerosing Cholangitis, And Idiopathic Neonatal Hepatitis; And The Liver Disease Related Complications Emanating From These Diseases.
background: The Childhood Liver Disease Research And Education Network (children) Is A Multi-center Consortium Of 10 Clinical Sites In The United States Plus A Scientific Data Coordinating Center Funded By Niddk To Study Rare Childhood Liver Diseases That Result In Cholestasis, Including Primary Sclerosing Cholangitis, Biliary Atresia, Alpha-one Antitrypsin Deficiency, Cystic Fibrosis Liver Disease, Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis (pfic), Bile Acid Synthesis Defects, Mitochondrial Respiratory Chain And Fatty Acid Oxidation Defects, And Idiopathic Neonatal Hepatitis. Five Ongoing Studies Being Conducted By Children Include: 1) A Prospective Database Of Infants With Cholestasis (probe), A Longitudinal Observational Study Starting In Infancy Which Has Enrolled 890 Infants With Biliary Atresia And 621 With Intrahepatic Cholestasis; 2) Biliary Atresia Study In Infants And Children (basic), A Longitudinal Study Of Children With Biliary Atresia Both Before And After Liver Transplant, Which Has Enrolled Over 1768 Children With Biliary Atresia 3) Longitudinal Study Of Genetic Causes Of Intrahepatic Cholestasis (logic), A Longitudinal Study Of Intrahepatic Cholestasis Diseases, Which Has Enrolled 474 Subjects With Alagille Syndrome, 572 With Alpha-1 Antitrypsin Deficiency Liver Disease, 355 With Pfic And 36 With Bile Acid Defects; 4) Longitudinal Study Of Mitochondrial Hepatopathies (mitohep) With 73 Participants; And 5) Prediction By Ultrasound Of The Risk Of Hepatic Cirrhosis In Cystic Fibrosis (push), A Study Of The Prognostic Value Of Hepatic Ultrasound On The Development Of Liver Fibrosis In Cf, Which Has Enrolled Over 770 Subjects. In Addition, Children Completed A Placebo-controlled Clinical Trial To Determine If Post-operative Corticosteroid Therapy Improves Serum Bilirubin And Survival Without Liver Transplantation In 140 Infants With Biliary Atresia Who Have Undergone The Kasai Surgery ("start"). Ancillary Studies To Evaluate The Natural History, Clinical Outcomes And Quality Of Life, Pathogenesis, Genetics And Genomics, Proteomics, Metabolomics, Lipidomics, Imaging Studies, And Determinants Of Progression And Severity Of These Cholestatic Liver Diseases Present A Variety Of Research Collaboration Opportunities. Children Is Also Interested In Conducting Clinical Trials Of Promising Therapies To Improve Clinical Outcomes For These Cholestatic Liver Diseases. Finally, Improved Diagnostics Or Screening Procedures For Biliary Atresia And Cholestasis In Infants Are Of Great Interest To Children.
study Goals: The Overall Goal Of Children Is To Determine The Etiology, Genetics, Pathogenesis, Natural History, Clinical Outcomes, Complications, Predictors Of Outcomes And Optimal Therapy Of The Cholestatic Liver Diseases. Children Studies Have Enrolled And Are Following A Relatively Large And Well Characterized Population Of Children And Young Adults With These Rare Disorders. Children Is Interested In Conducting Research That Will Lead To Improved Clinical Outcomes In Children And Young Adults With These Cholestatic Liver Diseases With Industry Collaborators To:
• Evaluate The Natural History, Pathogenesis, Diagnosis, Genetic Factors, Genomics, Proteomics, Metabolomics, Lipidomics, Epigenomics, Imaging Studies, And Determinants Of Progression And Severity Of Biliary Atresia, Alpha-one Antitrypsin Deficiency, Cystic Fibrosis Liver Disease, Alagille Syndrome, Pfic, Bile Acid Synthesis Defects, Mitochondrial Respiratory Chain And Fatty Acid Oxidation Defects, Primary Sclerosing Cholangitis, Or Idiopathic Neonatal Hepatitis.
• Explore Use Of Serum Markers For Fibrosis And Serum Markers For Disease Activity To Predict Hepatic Histology Either By Themselves Or In Combination With Other Clinical, Laboratory, Genomic, Proteomic, Metabolomic, And Lipidomic Variables
• Explore The Utility Of These Serum Markers As Surrogate Markers Of Therapeutic Response In Study Subjects Participating In Treatment Trials (e.g., Start Study For Biliary Atresia)
• Investigate Proprietary Drugs (such As Novel Choleretic Agents, Anti-fibrogenic Agents, Autophagy Inducers, Chloride Channel Inducers, Fat-soluble Vitamin Supplements, Bone Mineral Density Agents, Etc.), Reagents, Or Devices In Controlled Randomized Clinical Trials As Potential Diagnostics Or Therapies For Biliary Atresia, Alpha-one Antitrypsin Deficiency, Cystic Fibrosis Liver Disease, Alagille Syndrome, Pfic, Bile Acid Synthesis Defects, Mitochondrial Respiratory Chain And Fatty Acid Oxidation Defects, Primary Sclerosing Cholangitis, Or Idiopathic Neonatal Hepatitis
• Evaluate Novel Newborn Or Infant Screening Techniques Or Devices For Biliary Atresia Or Cholestasis.
• Evaluate Noninvasive Imaging Methods For Assessing Fibrosis, Biliary Disease, And Parenchymal Pathology In These Diseases Including But Not Limited To The Use Of Elastography, Nuclear Magnetic Resonance Imaging, And Molecular Imaging.
• Evaluate The Use Of Cytokine Assays For Analyses Of Serum/plasma Cytokine Levels As Markers Of Disease Activity And As Surrogate Markers Of Histologic Or Clinical Improvement In Therapeutic Trials
capability Statement: Commercial Organizations Interested In Pursuing Clinical Collaborations With Niddk For Childhood Cholestatic Liver Diseases Are Required To Submit A Capability Statement To Niddk. The Capability Statements Submitted In Response To This Announcement Will Be Used To Evaluate And Select Industry Collaborators. The Capability Statement Should Not Exceed 10 (ten) Pages Of Narrative (not Including Appendices) And Should Include The Following Information:
1. A Description Of The Therapeutic, Diagnostic Or Device Proposed To Be Used In The Clinical Research Study. (note: The Proposed Therapeutic Or Device Must Have Been Tested Already In A Phase I Trial In Humans.)
2. The Specific Details Of The Methods To Be Utilized In The Investigation Of The Pharmacologic, Surgical Or Device Intervention In Patients With Biliary Atresia, Alpha-one Antitrypsin Deficiency, Cystic Fibrosis Liver Disease, Alagille Syndrome, Pfic, Bile Acid Synthesis Defects, Mitochondrial Respiratory Chain And Fatty Acid Oxidation Defects, Primary Sclerosing Cholangitis, Or Idiopathic Neonatal Hepatitis, And A Clear Description Of All Important Issues Surrounding The Evaluation Of Disease Progression In These Patients.
3. A Detailed Plan Demonstrating The Ability To Provide Sufficient Quantities Of The Therapeutic, Diagnostic Or Device In A Timely Manner For The Duration Of The Study.
4. A Description Of All Laboratory Tests That Are Needed, Including Assays And Required Amount Of Specimens, To Determine Specific Biomarker Levels Along With Appropriate Methods For Performing Such Tests.
5. A Description Of Other Core Facilities And Interactions With Core Facilities That Are Needed For The Study.
6. Dosing And Pharmacokinetic Data From Human Studies For Any Novel Therapeutics.
7. Adverse Event Profile For The Proposed Therapeutic Or Device.
8. A Description Of The Practices And Procedures That Would Be Used To Assure Patient Privacy And Maintain Confidentiality Of Data Obtained From The Study.
9. (optional) Outcome Measures Of Interest To The Organization. The Specifics Of The Proposed Outcome Measures Should Include But Not Be Limited To Treatment And Evaluation Of Biliary Atresia, Alpha-one Antitrypsin Deficiency, Cystic Fibrosis Liver Disease, Alagille Syndrome, Pfic, Bile Acid Synthesis Defects, Mitochondrial Respiratory Chain And Fatty Acid Oxidation Defects, Primary Sclerosing Cholangitis, Or Idiopathic Neonatal Hepatitis.
10. Any Other Resources The Organization Proposes To Commit To The Collaboration (in Addition To The Proposed Therapeutic, Diagnostic Or Device), Which May Include Any Of The Following: Equipment, Reagents, Supplies, Access To Facilities, Personnel Or Services, And, If Appropriate, Funding (pursuant To A Cooperative Research And Development Agreement (crada) Authorized Under 15 U.s.c. § 3710a), To Help Support The Conduct Of The Clinical Study.
11. Affirmative Statements That The Organization:
a. Agrees To Provide A Letter Of Cross Reference To The Drug, Biologic Or Device Master File For The Proposed Therapeutic Or Device, Which Will Be Included With Any Us Fda Filing By The Ind Or Ide Sponsor Of The Children Study;
b. Agrees To Have The Proposed Therapeutic, Diagnostic Or Device Used In Children-developed Protocols Which Will Be Conducted By The Children Research Network For Which The Study Data Collection And Analysis Will Be Performed By The Children Scientific And Data Coordinating Center;
c. Agrees To Assure Patient Privacy And Will Maintain Confidentiality Of Data Obtained From The Study;
d. Agrees To Share All Safety Data From Other Studies Involving The Proposed Therapeutic Or Device As Well As Relevant Efficacy Data From Other Studies (updated Investigator Brochure, Etc) With The Children;
e. Understands That Because The Children Network Is Supported By Niddk Funding, The Study Results Will Be Published And Therefore Agrees To The Prompt Publication Of Research Results From The Clinical Study Using The Organization's Proposed Therapeutic, Diagnostic Or Device; And
f. Understands That The Clinical Study Will Be Conducted Under An Agreement With Niddk Which Must Adhere To Phs Intellectual Property Policies (see: Http://www.ott.nih.gov/policy/phspat_policy.aspx).
submission: Capability Statements Received By Niddk Will Be Considered. Prospective Collaborators May Be Invited To Attend, At Their Own Expense, A Children Steering Committee Meeting To Be Held In The Baltimore-washington, Dc Area To Discuss The Information In Their Capability Statement With The Steering Committee Members. Note:no Funds Will Be Provided By Niddk To Any Organization Selected For This Clinical Research Collaboration Opportunity.
submision And Inquiries: Submit Capability Statements To:
noo Coordinator, National Institute Of Diabetes And Digestive And Kidney Diseases
e-mail: Niddkottdip@niddk.nih.gov
for Scientific Inquiries Contact:
edward Doo, Md
director, Liver Diseases Research Program
division Of Digestive Diseases And Nutrition, Niddk
6707 Democracy Blvd., Room 6149
bethesda, Md 20892-5450
telephone: (301) 451-4524
fax: (301) 480-8300
e-mail: Dooe@niddk.nih.gov
katrina Loh, Md
director, Pediatric Gastrointestinal And Liver Diseases
division Of Digestive Diseases And Nutrition, Niddk
6707 Democracy Blvd., Room 6148
bethesda, Md 20892-5450
telephone: (301) 827-1079
fax: (301) 480-8300
e-mail: Katrina.loh@nih.gov
for Inquiries Regarding Partnering With Niddk (intellectual Property Matters And Collaboration Agreements) Contact:
agnes Rooke, Jd
technology Advancement Office
niddk, Nih, Hhs
telephone: 301-451-6072
e-mail: Agnes.rooke@nih.gov
this Notice Of Opportunity Is Also Posted At: Http://techdev.niddk.nih.gov/collabs.shtml.
Closing Date31 May 2029
Tender AmountRefer Documents
DEPT OF THE NAVY USA Tender
United States
Details: Request For Information
pursuant To Far 15.201(e) - 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. This Request For Information Does Not Commit The Government To Contract For Any Supply Or Service Whatsoever. Further, The Government Is Not At This Time Seeking Proposals And Will Not Accept Unsolicited Proposals. Responders Are Advised That The U.s. Government Will Not Pay For Any Information Or Administrative Costs Incurred In Response To This Rfi; All Costs Associated With Responding To This Rfi Will Be Solely At The Interested Party’s Expense. Interested Parties Are Responsible For Adequately Marking Proprietary Or Competition Sensitive Information Contained In Their Response. Proprietary Information Will Be Safeguarded In Accordance With The Applicable Government Regulations. Failure To Respond To This Rfi Does Not Preclude Participation In Any Future Associated Rfp That May Be Issued.
background/purpose/technical Requirements
the Naval Air Warfare Center Aircraft Division (nawcad) Webster Outlying Field (wolf) Division Is Soliciting Information And Comments From Industry On Its Ability To Provide Non-developmental Or Commercial Off The Shelf (cots) Network Radio Gateways (nrg) For Integration Into Full Scale Deployable And Scalable Transit Case Systems. The Nrgs Will Function As A Voice And Data Conferencing Center For Tactical And Commercial Radios, Internet Protocol Based Systems, And Cellular Phones.
responses
requested Information
section 1 Of The Response Shall Provide Administrative Information, And Shall Include The Following As A Minimum:
organization Name, Mailing Address, Overnight Delivery Address (if Different From Mailing Address), Phone Number, Fax Number, And Name And E-mail Of Designated Point Of Contact.
business Type (large Business, Small Business, Small Disadvantaged Business, 8(a)-certified Small Disadvantaged Business, Hub Zone Small Business, Woman-owned Small Business, Very Small Business, Veteran-owned Small Business, Service-disabled Veteran-owned Small Business).
country Of Origin For Main Component(s)
section 2 Of The Response Shall Provide Technical Information, And Shall Include The Following As A Minimum:
interested Parties Shall Respond With Existing Capabilities Or Products That Meet All Or A Subset Of The Aforementioned Attributes. Reponses That Include Information Detailing Potential Tradeoffs Or Alternative Solutions Is Encouraged.
respondents Should Provide A Detailed Description Of The Following Characteristics Of Their Solution In Their Submission:
product Specification, Sketches, Or Listings Of Authorized Distributors Are Not To Count As Part Of The Page Count.
list Of Certifications/standards/compliances (military Standards, Etc.)
operation
minimum And Maximum Operating And Storage Temperatures (in Fahrenheit)
humidity Range In Relative Humidity (operating & Non-operating)
features
dimensions (height X Width X Depth)
environmental Conditions
ruggedization (if Any)
connectors
power
other
radio Types Supported
radio Interfaces Supported
licensing Structure
disa Approved Products List Integrated Tracking System (aplits) Tracking Number (tn)
client Interface Description
input/output Interfaces
fault Reporting
power
other Information
total Quantity Of Units Sold To Date
date Of Delivery Of The First Unit
date Of Delivery Of Most Recent Unit
basic And Extended Warranty Information
time To Production
if Applicable And Able, Respondents Shall Include A List Of Department Of Defense (dod), Department Of Justice (doj) Or Department Of Homeland Security (dohs) Programs Of Record That Currently Employ Their Solution. It Would Be Helpful If A Sponsor Poc For Each Program, With Email Address And Phone Number Could Be Identified.
the Government Is Interested In Receiving Vendors’ Price Lists For Items They Believe Meet The Need In This Rfi. Supplying Price Data Does Not Imply A Contractual Obligation And Must Be Provided And Marked As Price Data.
respondents Should Include A List Of Authorized Distributors.
additional Information
in Response To This Rfi, Respondents Shall Submit Written Responses, Not-to-exceed Ten (10) Pages In Length Via Electronic Mail. Product Specification, Sketches, Or Listings Of Authorized Distributors Will Not Count Toward The Page Limitation. The Government Is Interested In Identification Of Long Lead Items(s), Sub-systems(s), Or Systems(s).
the Government Does Not Intend To Award A Contract On The Basis Of This Request Or To Otherwise Pay For The Information Solicited. Proprietary Information Will Be Safeguarded In Accordance With The Applicable Government Regulations. All Information Received In Response To The Rfi That Is Marked Proprietary Will Be Handled Accordingly. The Government Will Not Be Liable For Or Suffer Any Consequential Damages For Any Proprietary Information Not Properly Identified. Responses To This Rfi May Not Be Returned. Respondents May Not Be Notified Of The Result Of The Review.
failure To Respond To This Rfi Does Not Preclude Participation In Any Future Associated Rfp That May Be Issued. Information Provided In No Way Binds The Government To Solicit Or Award A Contract. It Is The Potential Vendor’s Responsibility To Monitor This Site For The Release Of Any Follow-on Information.
how To Respond
interested Parties Are Requested To Respond To This Rfi With A Pdf Document Format. Responses Shall Be Limited To 10 Pages And Submitted Via E-mail Only To Truman.b.harris3.civ@us.navy.mil. Proprietary Information, If Any, Should Be Minimized And Must Be Clearly Marked. Responses Are Due No Later Than 24 January 2024, 10:00 A.m. Est.
responses To This Rfi May Not Be Returned. Respondents May Not Be Notified Of The Result Of The Review. It Is The Potential Vendor’s Responsibility To Monitor This Site For The Release Of Any Follow-on Information.
Closing Date4 Dec 2024
Tender AmountRefer Documents
National Institutes Of Health Tender
Others
United States
Details: The National Institute Of Diabetes And Digestive And Kidney Diseases (niddk) Seeks Industry Partners For Clinical Research Collaborations On Therapeutics, Diagnostics Or Devices For The Liver Cirrhosis Network
the National Institute Of Diabetes And Digestive And Kidney Diseases (niddk) Of The National Institutes Of Health (nih) Of The Department Of Health And Human Services (dhhs) Has Released Requests For Applications Rfa-dk-20-003 And Rfa-dk-20-004 For The Establishment Of The Liver Cirrhosis Network; And Seeks Industry Collaborators To Provide Novel Or Repurposed Therapeutic Agents, Diagnostic Markers, Biomarkers, Devices, Or Services For Use In Nih-sponsored Multi-center Clinical Trials And Ancillary Studies In Adult Patients With Advanced Liver Disease And Cirrhosis; And The Hepatic And Extrahepatic Related Complications Emanating From Cirrhosis.
background: The Niddk Is Proposing The Establishment Of The Liver Cirrhosis Network Through Funding Opportunity Announcements Rfa-dk-20-003 Seeking Clinical Centers; And In Conjunction With Rfa-dk-20-004 Seeking A Single Scientific Data Coordination Center, In Order To Promote Clinical And Translational Research On Cirrhosis Of The Liver And Related Complications In Adults.
cirrhosis Represents Not A Single Disease But Is Rather The Consequence And Major Serious Outcome Of Many Chronic Liver Diseases, Caused By A Wide Range Of Conditions. The Etiologies Of Cirrhosis In The United States Include Infectious Causes Such As Chronic Hepatitis B, C And D; Genetic Causes Such As Wilson Disease, Hemochromatosis And Alpha-1-antitrypsin Deficiency; Metabolic Causes Such As Nonalcoholic Steatohepatitis; Autoimmunity Such As Autoimmune Hepatitis, Primary Biliary Cholangitis And Sclerosing Cholangitis; And Toxic Causes Such As Alcohol-associated Liver Disease And Chronic Liver Injury From Medications Such As Methotrexate And Amiodarone. Cirrhosis From These Diseases Is Almost Always The Result Of Chronic Injury With Persistent Inflammation And Cell Damage That Results In Faulty Healing And Fibrosis. As Fibrosis Accumulates It Causes Distortion Of The Architecture Of Liver, Portal Hypertension And Compromise Of Liver Function. Clinical Complications Of Cirrhosis Include Symptoms Of Fatigue, Weakness, Weight Loss, Itching And Jaundice; Gastrointestinal Bleeding From Varices Or Portal Hypertensive Gastropathy, Coagulopathy, Ascites And Disturbance Of Fluid And Electrolyte Balance, Renal Dysfunction And Hepatic Encephalopathy. The Most Dreaded Complication Of Cirrhosis Is Hepatocellular Carcinoma, A Highly Fatal Cancer That Arises In 1 To 3% Of Persons With Cirrhosis Yearly. Once Cirrhosis Is Present, Treatment Of The Underlying Liver Disease Can Lessen Further Progression And Deterioration, But Does Not Eliminate All Risk Of Complications, Particularly Hepatocellular Carcinoma.
mortality Due To Liver Disease Remains A Significant Public Health Burden In The United States, Currently Ranked 11th Overall And Ranking 6th In Persons Below The Age Of 65 Years. Cirrhosis Appears To Be Rising In Some Populations Such As Persons Living With Hiv Infection, Nonalcoholic Fatty Liver Disease And Cystic Fibrosis. Hepatocellular Carcinoma Incidence Is Also Rising In The United States And Is A Surrogate For The Prevalence Of Cirrhosis.
treatment Of Underlying Causes Of Chronic Liver Disease Such As Antivirals For Chronic Hepatitis B And C; Therapeutic Phlebotomy For Genetic Hemochromatosis; Ursodiol For Primary Biliary Cirrhosis; Weight Loss For Nonalcoholic Steatohepatitis (nash), And Cessation Of Alcohol Consumption For Alcohol-associated Liver Disease, All Underpin The Overarching Clinical Approach To Prevent The Development Of Cirrhosis By Early Abrogation Of Ongoing Injury To The Still Noncirrhotic Liver. Neutralization Of The Liver Disease Etiology May Allow The Injured Liver To Invoke Endogenous Mechanisms To Reverse The Consequences Of Chronic Inflammation And The Accumulation Of Mild Or Even Modest Amounts Of Liver Fibrosis. However, Once Advanced Fibrosis Or Cirrhosis Has Been Established, Neutralization Of The Causes Of Liver Disease Generally Will Not Reverse Fibrosis Or Cirrhosis Completely. While The Residual Risk Of Complications May Be Decrease, This May Be Off-set By The Improvement In Survival, So That Patients With Cirrhosis And Advanced Fibrosis Will Live And Be At Risk For The Complications Longer.
liver Transplantation Is Currently The Only Medically Viable Avenue For Patients With End-stage Liver Disease That Will Extend Their Longevity. On An Annual Basis, Despite Treatment Success Rates For Chronic Hepatitis C And Other Liver Diseases, The National Wait List For Liver Transplantation In The United States Remains Essentially Unchanged At Approximately 13,000 Patients. Only 8000 Liver Transplantations Are Performed Annually. However, Far, Far More Patients With End-stage Liver Disease Are Not Even Placed On Liver Transplantation Lists For A Variety Of Co-morbid Or Psychosocial Issues.
given The Discrepancy Between The Need And The Availability Of Liver Organs For Patients On Liver Transplant Waiting Lists And The Even More Numerous Patients Who Are Unable To Be Considered For Listing For Liver Transplantation, There Is A Significant Need To Improve Our Understanding Of Clinical And Translational Scientific Aspects Of Liver Fibrosis And Cirrhosis. In Addition, There Is A Need For Furthering Fundamental Understanding Of Both The Underlying Pro- And Anti-fibrotic Mechanisms As Well As Risk Factors And Mechanisms That Accentuate Pro- And Anti-fibrotic Processes.
study Goals: The Overall Goal Of The Liver Cirrhosis Network Is To Promote Clinical And Translational Research That Will Advance The Understanding Of Liver Fibrosis And Cirrhosis Pathophysiology; Improve Clinical Management Of Liver Cirrhosis And Complications Of Advanced Fibrosis; And To Conduct Clinical Trials To Alter Cirrhosis Liver Disease Trajectory And The Related Complications. While Specific Details Of The Protocols For The Liver Cirrhosis Network Are Yet To Be Defined And Will Be Made By Consensus By The Future Steering Committee Of The Network, It Is Expected That Sufficient Numbers Of Subjects Will Be Enrolled With Either Stable, Child Class A, Cirrhosis Or Evidence Of Advanced Fibrosis (such As Bridging Fibrosis On Liver Biopsy Or Evidence Of Advanced Disease As Assessed By Validated Non-invasive Markers) To Operationalize The Eventual Network Studies. An Attempt Will Be Considered To Enroll Subjects With All Forms Of Cirrhosis (viral, Autoimmune, Genetic, Toxic, Alcohol-associated And “cryptogenic”) And With A Diverse Range Of Demographics As Typifies Chronic Liver Disease In The United States.
the Liver Cirrhosis Network Is Interested In Conducting Research That Will Lead To Improved Clinical Outcomes In Adults With Cirrhosis And Advanced Liver Disease With Industry Collaborators To:
• Evaluate The Natural History, Pathogenesis, Diagnosis, Genetic Factors, Genomics, Proteomics, Metabolomics, Lipidomics, Epigenomics, Imaging Studies, And Determinants Of Progression And Severity Of Advanced Liver Disease And Cirrhosis-related Complications
• Explore Use Of Serum Markers For Fibrosis And Serum Markers For Disease Activity To Predict Hepatic Histology Or Function Either By Themselves Or In Combination With Other Clinical, Laboratory, Genomic, Proteomic, Metabolomic, And Lipidomic Variables
• Explore The Utility Of These Serum Markers As Surrogate Markers Of Therapeutic Response In Study Subjects Participating In Treatment Trials
• Investigate Proprietary Or Repurposed Drugs (such As Statins, Anti-fibrogenic Agents, Autophagy Inducers, Chemo-preventive Agents, Nonsteroidal Anti-inflammatory Agents, Etc.), Reagents, Or Devices In Controlled Randomized Clinical Trials As Potential Diagnostics Or Therapies For Advanced Liver Disease, Cirrhosis And Cirrhosis Related Complications
• Evaluate Noninvasive Imaging Methods For Assessing Fibrosis, Portal Vein Hypertension, Hepatic Function, Screening For Or Diagnosis Of Liver Cancer, And Parenchymal Pathology In Cirrhosis Liver Disease Including But Not Limited To The Use Of Elastography, Nuclear Magnetic Resonance Imaging, And Molecular Imaging.
• Evaluate The Use Of Cytokine Assays For Analyses Of Serum/plasma Cytokine Levels As Markers Of Disease Activity And As Surrogate Markers Of Histologic Or Clinical Improvement In Therapeutic Trials
capability Statement: Commercial Organizations Interested In Pursuing Clinical Collaborations With Niddk For Cirrhosis Liver Disease Are Required To Submit A Capability Statement To The Niddk. The Capability Statements Submitted In Response To This Announcement Will Be Used To Evaluate And Select Industry Collaborators. The Capability Statement Should Not Exceed 10 (ten) Pages Of Narrative (not Including Appendices) And Should Include The Following Information:
1. A Description Of The Therapeutic, Diagnostic Or Device Proposed To Be Used In The Clinical Research Study. (note: The Proposed Therapeutic Or Device Must Have Been Tested Already In A Phase I Trial In Humans.)
2. The Specific Details Of The Methods To Be Utilized In The Investigation Of The Pharmacologic, Surgical Or Device Intervention In Patients With Cirrhosis Liver Disease, And A Clear Description Of The Important Issues Surrounding The Evaluation Of Disease Progression In These Patients.
3. A Detailed Plan Demonstrating The Ability To Provide Sufficient Quantities Of The Therapeutic, Diagnostic Or Device Either In Total Prior To Study Initiation (preferred If Possible) Or In A Timely Manner For The Duration Of The Study.
4. A Description Of All Laboratory Tests That Are Needed And Proficiency In Conducting These Laboratory Tests, Including Assays And Required Amount Of Specimens, To Determine Specific Biomarker(s) Levels And List Potential Biomarkers, Along With Appropriate Methods For Performing Such Tests.
5. A Description Of Other Core Facilities And Interactions With Core Facilities That Are Needed For The Study.
6. Dosing, Pharmacodynamic, And Pharmacokinetic Data From Human Studies For Any Novel Therapeutics.
7. Adverse Event Profile For The Proposed Therapeutic Or Device.
8. A Description Of The Practices And Procedures That Would Be Used To Assure Patient Privacy And Maintain Confidentiality Of Data Obtained From The Study.
9. (optional) Outcome Measures Of Interest To The Organization. The Specifics Of The Proposed Outcome Measures Should Include But Not Be Limited To Treatment And Evaluation Of Cirrhosis Liver Disease Or Cirrhosis Related Complications.
10. Any Other Resources The Organization Proposes To Commit To The Collaboration (in Addition To The Proposed Therapeutic, Diagnostic Or Device), Which May Include Any Of The Following: Equipment, Reagents, Supplies, Access To Facilities, Personnel Or Services, And, If Appropriate, Funding (pursuant To A Cooperative Research And Development Agreement (crada) Authorized Under 15 U.s.c. § 3710a), To Help Support The Conduct Of The Clinical Study.
11. Affirmative Statements That The Organization:
a. Agrees To Provide A Letter Of Cross Reference To The Drug, Biologic Or Device Master File For The Proposed Therapeutic Or Device, Which Will Be Included With Any Us Fda Filing By The Ind Or Ide Sponsor Of The Liver Cirrhosis Network Study;
b. Agrees To Have The Proposed Therapeutic, Diagnostic Or Device Used In The Liver Cirrhosis Network-developed Protocols Which Will Be Conducted By The Liver Cirrhosis Network Research Network For Which The Study Data Collection And Analysis Will Be Performed By The Liver Cirrhosis Network Scientific And Data Coordinating Center;
c. Agrees To Assure Patient Privacy And Will Maintain Confidentiality Of Data Obtained From The Study;
d. Agrees To Share All Safety Data From Other Studies Involving The Proposed Therapeutic Or Device As Well As Relevant Efficacy Data From Other Studies (updated Investigator Brochure, Etc) With The Liver Cirrhosis Network;
e. Understands That Because The Liver Cirrhosis Network Is Supported By Niddk Funding, The Study Results Will Be Published And Therefore Agrees To The Prompt Publication Of Research Results From The Clinical Study Using The Organization's Proposed Therapeutic, Diagnostic Or Device;
f. Has Intellectual Property Rights To Provide Laboratory Test/biomarker(s), Therapeutic Or Device To Niddk For Testing And Has No Current Agreements Or Arrangements That Could Impede This Right; And
f. Understands That The Clinical Study Will Be Conducted Under An Agreement With Niddk Which Must Adhere To Phs Intellectual Property Policies (see: Http://www.ott.nih.gov/policy/phspat_policy.aspx).
submission: Capability Statements Received By Niddk Will Be Considered. Prospective Collaborators May Be Invited To Attend, At Their Own Expense, A Liver Cirrhosis Network Steering Committee Meeting To Be Held In The Baltimore-washington, Dc Area To Discuss The Information In Their Capability Statement With The Steering Committee Members. Note:no Funds Will Be Provided By Niddk To Any Organization Selected For This Clinical Research Collaboration Opportunity.
submision And Inquiries: Submit Capability Statements To:
noo Coordinator, National Institute Of Diabetes And Digestive And Kidney Diseases
e-mail: Niddkottdip@niddk.nih.gov
for Scientific Inquiries Contact:
edward Doo, Md,
director, Liver Diseases Research Program
division Of Digestive Diseases And Nutrition, Niddk
6707 Democracy Blvd., Room 6149
bethesda, Md 20892-5450
telephone: (301) 451-4524
fax: (301) 480-8300
e-mail: Dooe@niddk.nih.gov
for Inquiries Regarding Partnering With Niddk (intellectual Property Matters And Collaboration Agreements) Contact:
agnes Rooke, Jd
technology Advancement Office
niddk, Nih, Hhs
telephone: 301-451-6072
e-mail: Agnes.rooke@nih.gov
this Notice Of Opportunity Is Also Posted At: Http://techdev.niddk.nih.gov/collabs.shtml.
Closing Date16 May 2026
Tender AmountRefer Documents
211-220 of 221 active Tenders