Contract

Tracy Fish Collection Facility Louver Guide Rod Replacement Project

• Department/Ind.Agency INTERIOR, DEPARTMENT OF THE
• Subtier BUREAU OF RECLAMATION
• Office MP-REGIONAL OFFICE

Asbestos removal and carpet installation for building 470 hallway

• Department/Ind.Agency DEPT OF DEFENSE
• Subtier DEPT OF THE AIR FORCE
• Office FA4626 341 CONS LGC

NREL is seeking Electrical Equipment Substation Preventative Maintenance Services Amended The National Renewable Energy Laboratory NREL is a national laboratory owned by the US Department of Energy DOE NREL is the only federal laboratory dedicated to research development commercialization and deployment of renewable energy and energy efficiency technologies NREL is managed and operated for DOEs Office of Energy Efficiency and Renewable Energy by The Alliance for Sustainable Energy Alliance the MO Contractor The National Renewable Energy Laboratory NREL currently consists of over 630 acres or approximately 1 million square feet across more than 40 buildings ranging in age from new construction to over 40 years old NREL has multiple Facility Managers that manage these buildings throughout all campuses NRELs is looking for a Subcontractor to provide maintenance and testing of onsite electrical equipment in accordance with the NREL Electrical Safety Program This Statement of Work covers all labor supplies materials replacement parts equipment transportation to and from the site and any other goods and services required to complete the scope as outlined in this Statement of Work Important Dates Due 3112024 Notice of Intent to Submit A ProposalAttend Conference Due 4122024 Technical Questions See attached Amendment 1 Due 5102024 Proposal Due at 12pm Mountain Time  See Attached Amendment 2 See attached documents for all other details

• Department/Ind.Agency ENERGY, DEPARTMENT OF
• Subtier ENERGY, DEPARTMENT OF
• Office ALLIANCE SUSTAINABLE ENRGY-DOECONTR

Amendment 1 A Question and Response document is posted and the anticipated RFP issue date is postponed to on or after April 15 2024 Amendment 2 An updated Question and Response document is posted INTRODUCTION PURSUANT TO FAR Subpart 52 Synopses of Proposed Contract Actions THIS IS A PRESOLICITATION NOTICE OF A PROPOSED CONTRACT ACTION The National Institute on Drug Abuse NIDA Office of Acquisition OA on behalf of the National Institutes of Neurological Disorders and Stroke NINDS intends to award one or more Indefinite Delivery Indefinite Quantity IDIQ contracts for Manufacturing and Nonclinical Studies Support for the Development of Therapeutic Biotechnology Products Biologics for Neurologicalrelated Disorders It is anticipated that the IDIQ awards will be made in the first quarter of Fiscal Year 2025 and will allow for the issuance of fixedprice and costreimbursement type task orders A Request for Proposals RFP Number 75N95024R00050 entitled Manufacturing and Nonclinical Studies Support for the Development of Therapeutic Biotechnology Products Biologics for Neurologicalrelated Disorders is anticipated to be issued on SAMgov on or after April 15 2024  PLEASE NOTE This solicitation is a RampOn reopening and resoliciting of Request for Proposals RFP No 75N95022R00013 that was issued on January 25 2022 with the purpose of adding one or more contractors to the existing Indefinite Delivery Indefinite Quantity IDIQ contract pool supporting this program The ordering period of the IDIQ contracts expire on September 29 2030 and any new awards made under RFP No 75N95024R00050 will have an ordering period that expires on September 29 2030  DESCRIPTION OF REQUIREMENT The National Institutes of Neurological Disorders and Stroke NINDS has a need for current Good Manufacturing Practices cGMP manufacturing and Good Laboratory Practice GLP nonclinical preclinical support services to support translational development of therapeutic biotechnology products Biologics for National Institutes of Health NIH drug discovery and development programs To that end several NIH programs are being implemented or expanded to provide support for academic and industry investigators developing medical interventions for neurological disorders This requirement supports the NIH biologics development projects for the NIH Blueprint Neurotherapeutics Network Biologics BPNBiologics program the NINDS UltraRare Gene Therapy URGenT program the Helping to End Addiction Longterm Pain Therapeutics Development Program HEALPTDP as well as other extramural or intramural NIH drug discovery and development programs The Contractor shall provide support for both Biologics current good manufacturing practices cGMP manufacturing and GLP nonclinical services including execution of the studies and completing study reports and documentation that will enable regulatory filing and evaluation of biological therapeutics in clinical trials for NIH drug development programs These services may be provided through a combination of internally executed studies and subcontracted work Throughout the contract ordering period and awarded task order TO periods of performance the Contractor must maintain the technical capabilities subcontractor network minimum resources and organizational compliances with which to successfully perform the range of activities under both Task Area 1 Manufacturing and Task Area 2 Nonclinical Studies Additionally unless otherwise requested any assigned research must be performed in compliance with all current Food and Drug Administration FDA and International Committee on Harmonization ICH policies practices procedures guidelines and regulations specific to GLP and cGMP as may be applicable Data and documentation shall be prepared in a form acceptable to the FDA for inclusion in a Drug Master File DMF Investigational New Drug IND application or New Drug Application NDA In its own facilities andor through its subcontractors the Contractor shall conduct andor oversee all manufacturing activities and nonclinical therapeutics evaluation and characterization in appropriate in vitro in vivo andor ex vivo models including cGMP manufacturing and preclinical INDenabling and related studies Nonclinical activities may include but not are limited to bioassay development andor efficacy studies andor absorption distribution metabolism and elimination ADME studies andor pharmacokinetic PK andor pharmacodynamic PD characterization andor GLP toxicology studies or other preclinical INDenabling studies in support of requirements for IND applications The Contractor shall provide Chemistry manufacturing and controls CMC and nonclinical study documentation to enable regulatory interactions IND filing and evaluation of biological therapeutics in clinical trials for NIH drug development programs The Contractor shall effectively and efficiently manage cost schedule and performance under any resultant contracttask orders by using integrated program management processes across all aspects of performance and in a manner that yields cost savings andor performance efficiencies throughout the execution of all task orders issued to the Contractor  The Contractor shall provide project management for its own core team to ensure project planning execution delivery of reports and accurate and timely communication with the NIH Contracting Officer CO Contracting Officers Representative COR and other stakeholders The Contractor shall have a designated head Program Manager as the point of contact for the contract The Contractor shall also provide a project management plan for how subcontracted work will be executed including but not limited to how qualified subcontractors will be identified how studies will be scheduled to meet NIH timelines and how subcontractor work will be managed and overseen The Contractor shall provide project management support for the overall administration of the contract and development tracking and management of all task orders issued under the contract The Contractors project management support staff shall work in coordination with designated federal staff and will be responsible for performing all the noninherently governmental activities associated with administration of the contract Independently and not as an agent of the Government the contract awardees shall furnish all the necessary services qualified personnel materials equipment and facilities not otherwise provided by the Government as needed to perform the actions outlined in each of the following Task Areas Task Area 1 Manufacturing Manufacturing of biological therapeutic modalities required to support BPNBiologics URGenT HEAL PTDP or other biologics programs includes but is not limited to the following categories of biologics 1 Oligonucleotides such as antisense oligonucleotide ASOs small interfering RNAs siRNAs andor other nucleic acids such as plasmid DNAs for generating viral gene vectors etc 2 Viral gene delivery vectors such as adenovirusassociated viruses AAV lentiviruses retroviruses herpesviruses adenoviruses etc 3 Purified proteins including purification of polypeptides from a variety of expression systems including prokaryotic mammalian avian yeast insect or plant and may include protein modifications such as bioconjugation or other protein modifications 4 Peptides including those with modified amino acids structures or conjugations 5 Antibodybased Biologics including antibodydrug conjugates ADCs bi and multispecific antibodies peptibodies nanobodies antibody fragments etc 6 Cellbased therapeutics such as iPSC cell line generation stem cell mesenchymal stromal cell therapies ex vivo cellular therapies chimeric antigen receptor Tcell CART modalities cell banks for bioassays andor for manufacturing viral vectors etc 7 Novel genomeediting modalities such as clustered regularly interspaced short palindromic repeats CRISPRCas9 etc 8 Formulations of biological therapeutics including common formulations for biologics andor liposomes micelles polymers or solid metallic nanoparticle formulations Manufacturing services for the Biologics listed above may include but are not limited to the following subtasks 1 Technologytransfer of an RD laboratory scale process from a research facility to the Contractor 2 Biological therapeutics manufacturing process development 3 Analytical Methods Development 4 CMC development 5 Smallscale manufacture scaleup engineering runs andor manufacturing under cGMP 6 Formulation and Dosage Form Manufacture and Validation 7 Fillfinish release testing stability testing validation and other associated tasks Task Area 2 Nonclinical Studies Nonclinical services include conduct of in vitro in vivo andor ex vivo studies as well as the completion of associated nonclinical study reports and documentation that will enable regulatory filing and evaluation of biological therapeutics in clinical trials for NIH drug development programs Nonclinical studies may include but are not limited to 1 GLP or nonGLP efficacy testing in in vitro in vivo or ex vivo models including modeling neurological disease using patient derived pluripotent stem cells or in animal models of disease or in naïve animals or in ex vivo tissue or small explant cultures  2 GLP or nonGLP ADME studies PK and PD characterization toxicology studies including but not limited to singledose andor repeat dose toxicology studies andor reproductive toxicology andor carcinogenicity studies andor neonatal and juvenile toxicology studies in small animal large animal andor nonhuman primate NHP models and 3 Bioassay development andor assay qualification or validation to support nonclinical or clinical studies 4 All nonclinical work GLP and nonGLP should be conducted in facilities that are GLP capable and compliant unless a written waiver is given by the COR for work to be conducted in a nonGLP capable facility The Contractor shall perform in vivo in vitro andor ex vivo characterization studies including but not limited to the following 1 The Contractor andor subcontractors shall perform efforts associated with planning conducting and reporting on approved in vitro andor ex vivo characterization studies andor in vivo animal studies nonGLP andor GLP as directed by each individual TO and in accordance with approved protocols Efficacy testing may include studies with in vitro in vivo or ex vivo models including but not limited to modeling neurological disease using patient derived pluripotent stem cells andor in ex vivo tissue or small explant cultures The Contractor andor subcontractors shall assist with a broad range of animal efficacy studies to support preclinical research involving species such as NHP rodent andor other small or large mammalian animal models Support may include acquisition housing and care of animals health monitoring and surveillance procedures in high containment areas imaging laboratory animal medicine sample collection model development and immunogenicity safety and efficacy testing generate positron emission tomography PET andor other radiolabeled ligands for distribution studies etc 2 The Contractor shall perform as directed by a TO and according to approved protocols all types of PK and toxicology studies required for advancing an agent into clinical testing In vivo general toxicology safety pharmacology and efficacy studies via oral intramuscular IM intravenous IV subcutaneous SC intrathecal IT ocular intraperitoneal IP or other routes of administration for INDBiologics License Applications BLAenabling nonclinical packages may include but are not limited to a    NonGLP range finding studies in rodent and nonrodent species b    Dose ranging andor maximum tolerable dose MTD studies to define the highest dose of a biologic therapeutic that does not cause unacceptable side effects or toxicity c    GLP studies in rodent and nonrodent species d    Singledose andor repeatdose safety pharmacology studies pulmonary cardiovascular or other in relevant species including the assessment of effects on vital functions such as cardiovascular central nervous renal gastrointestinal hepatic and respiratory systems These evaluations may be conducted as part of an existing study or in a separate study and must comply with ICH Guidelines e    Reproductive toxicology studies f    Carcinogenesis studies in rodent and nonrodent models g    NonGLP andor GLP efficacy studies in appropriate animal models of neurological diseases h    Develop or adapt and validate appropriate analytical methodology which is sufficiently sensitive specific and reproducible to allow measurement and quantitation of assigned test agents and metabolites in body fluids andor tissues of animals at therapeutic andor toxic concentrations i    Conduct PK studies in animals eg rodent and nonrodent using various routes of administration eg intravenous oral intraperitoneal subcutaneous continuous infusion etc Studies will include collection of multiple blood samples by suitable methods to obtain plasma or serum and in some studies collection of urine feces and tissue samples including brain  j    Use modern modeling software to fit concentration versus time data for plasma brain and possibly tissues to appropriate PK models and calculate relevant PK parameters eg halflife volume of distribution area under the curve clearance brain to plasma ratio etc for a given agent and route of administration Calculate systemic bioavailability for various routes eg oral ip sc and determine if bioavailability is dose dependent 3 Bioassay development andor assay qualification or validation to support nonclinical or clinical studies may include but is not limited to a    Neutralizing antibody assays including assays to measure neutralizing antibodies to viral vectors such as AAVs or other viral vector modalities used in genetherapy studies b    Enzymelinked immunosorbent assays ELISA c    Relative potency assays to support release testing of manufactured biologics d    Assays that measure the biological activity of a bioactive molecule including ligandreceptor binding or signal transduction processes etc e    Human or animal tissue bioassays f    Suitable analytical methods to determine concentrations of test agents in biological samples eg plasma urine bile saliva brain and other tissues CLOSING INFORMATION Offerors are required to be registered in the System for Award Management SAM when submitting an offer or quotation and shall continue to be registered until time of award during performance and through final payment of any contract basic agreement basic ordering agreement or blanket purchasing agreement resulting from a solicitation Processing time should be taken into consideration when registering Offerors who are not registered in SAM should consider applying for registration immediately upon receipt of this presolicitation See FAR 522047 System for Award Management Oct 2018 and httpswwwsamgov for information on registration This is NOT a Request for Proposals RFP Request for Proposals RFP No 75N95024R00050 will be available electronically and may be accessed through SAM URL httpswwwsamgov 15 or more calendar days after the issuance of this synopsis THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE SAM WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED All responsible sources may submit a proposal which shall be considered by the agency  

• Department/Ind.Agency HEALTH AND HUMAN SERVICES, DEPARTMENT OF
• Subtier NATIONAL INSTITUTES OF HEALTH
• Office NATIONAL INSTITUTES OF HEALTH NIDA

No Description Provided

• Department/Ind.Agency DEPT OF DEFENSE
• Subtier DEFENSE LOGISTICS AGENCY
• Office DLA AVIATION

No Description Provided

• Department/Ind.Agency DEPT OF DEFENSE
• Subtier DEFENSE LOGISTICS AGENCY
• Office DLA LAND AND MARITIME

No Description Provided

• Department/Ind.Agency DEPT OF DEFENSE
• Subtier DEFENSE LOGISTICS AGENCY
• Office DLA LAND AND MARITIME

No Description Provided

• Department/Ind.Agency DEPT OF DEFENSE
• Subtier DEFENSE LOGISTICS AGENCY
• Office DLA AVIATION

No Description Provided

• Department/Ind.Agency DEPT OF DEFENSE
• Subtier DEFENSE LOGISTICS AGENCY
• Office DLA LAND AND MARITIME

Full Facility Access and Use of Various Instruments in the Materials Characterization Facility MCF at Carnegie Mellon University for the purposes of carrying out research projects

• Department/Ind.Agency ENERGY, DEPARTMENT OF
• Subtier ENERGY, DEPARTMENT OF
• Office NATIONAL ENERGY TECHNOLOGY LABORATORY