Research and Training Funding

Funding Opportunity Announcements

Browse below for Data Science Funding Opportunity Announcements.

This page last reviewed on August 7, 2019

Feed last updated: December 01 2020 6:41 pm
Title FOA Number Organization Release Date Expiration Date Purpose Search Terms
Publication of the Revised NIH Grants Policy Statement (Rev. December 2019) for FY 2020 NOT-OD-20-043 NIH Dec 10 2019 N/A Publication the Revised NIH Grants Policy Statement Rev. December 2019) FY 2020 Notice Number: NOT-OD-20-043 Key Dates Release Date: December 10, 2019 Related Announcements None Issued Office The Director, National Institutes Health OD) Purpose National Institutes Health NIH) announces publication the revised NIH Grants Policy Statement NIHGPS, rev. December 2019). revision applicable all NIH grants cooperative agreements budget periods beginning or after October 1, 2019. revision supersedes, its entirety, NIH Grants Policy Statement October 2018) a standard term condition award. Previous versions the NIHGPS remain applicable a standard term condition all NIH grants cooperative agreements budget periods began prior October 1, 2019. NIHGPS provides both up-to-date policy guidance serves NIH standard terms conditions awards grants cooperative agreements, extensive guidance those are interested pursuing NIH grants. While revision does introduce any new material the first time, incorporates new modified requirements, clarifies certain policies, implements changes statutes, regulations, policies have implemented through appropriate legal and/or policy processes since previous version the NIHGPS dated October 2018. document available the following electronic formats: HTML PDF http://grants.nih.gov/grants/policy/nihgps/index.htm). Prior versions the NIHGPS accessible at http://grants.nih.gov/grants/policy/policy.htm#gps. NIH continue publish interim grants policy changes through issuance NIH Guide Notices found at http://grants.nih.gov/grants/guide/index.html. change be described, including applicability effective date; the necessary language implement as term condition award provided. document available summarizes significant changes are implemented the December 2019 NIHGPS: https://grants.nih.gov/grants/policy/nihgps/Significant-Changes-Table-NI... Inquiries Please direct inquiries to: NIH Office Policy Extramural Research Administration OPERA) Telephone: 301-435-0949 Email: grantspolicy@mail.nih.gov
Providing Research Education Experiences to Enhance Diversity in the Next Generation of Substance Use and Addiction Scientists (R25 Clinical Trials Not Allowed) PAR-20-236 NIDA Oct 28 2020 Nov 16 2023 The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.
Promoting Viral Suppression among Individuals from Health Disparity Populations Engaged in HIV Care (R01 Clinical Trial Required) RFA-MD-21-002 NIMHD Nov 05 2020 Jan 16 2021 This initiative will support R01 intervention projects to promote antiretroviral therapy (ART) initiation, ART adherence, and suppressed viral load for people living with HIV (PLWH) from health disparity populations engaged in HIV care.
Promoting Research on Music and Health: Phased Innovation Award for Music Interventions (R61/R33 Clinical Trial Optional) PAR-20-266 NCCIH Jul 15 2020 Jun 20 2023 The purpose of this Funding Opportunity Announcement (FOA) is to promote innovative research on music and health with an emphasis on developing music interventions aimed at understanding their mechanisms of action and clinical applications for the treatment of many diseases, disorders, and conditions. Given the emphasis on innovation, little or no preliminary data are needed to apply under this FOA. Because of the need for a multidisciplinary approach, collaborations among basic researchers, translational science researchers, music intervention experts, other clinical researchers, music health professionals, and technology development researchers are encouraged. The FOA utilizes a phased R61/R33 funding mechanism to support mechanistic research and to evaluate the clinical relevance of music interventions. The R61 phase will provide funding to either investigate the biological mechanisms or behavioral processes underlying music interventions in relevant animal models, healthy human subjects, and/or clinical populations, or can be used to develop innovative technology or approaches to enhance music intervention research. The second R33 phase will provide support for further mechanistic investigations in human subjects or animal models, intervention development, or pilot clinical studies. The pilot clinical studies may focus on intervention optimization/refinement, feasibility, adherence, and/or identification of appropriate outcome measures to inform future clinical research. Transition from the R61 to the R33 phase of the award will depend on successful completion of pre-specified milestones established in the R61.
Prohibition on Expending NIH Grant Funds for Covered Telecommunications Equipment or Services NOT-OD-21-030 NIH Nov 23 2020 N/A Effective August 13, 2020, the Office of Management and Budget revised 2 Code of Federal Regulations 200 to align with Section 889 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Public Law 115-232). This new section, 2 CFR 200.216, Prohibition on certain telecommunication and video surveillance services or equipment, prohibits Federal award recipients from using government funds to enter contracts (or extend or renew contracts) with entities that use covered telecommunications equipment or services.
Presolicitation Notice: Request for Proposals (RFP) 75N91021R00007 "Preclinical Pharmacokinetic and Pharmacology Evaluations of Agents Being Developed for Cancer Patients" NOT-CA-21-011 NCI Nov 04 2020 N/A NCI expects to release a Request for Proposals (RFP 75N91021R00007) to support the NCI Experimental Therapeutics (NExT) Program.
Presolicitation Notice: Request for Proposals (RFP) 75N91021R00004"Preclinical Toxicology of Large Molecule Drugs Developed for Cancer and Other Indications" NOT-CA-21-013 NCI Nov 04 2020 N/A NCI expects to release a Request for Proposals (RFP 75N91020R00004) for conducting toxicology studies.
Presolicitation Notice: Request for Proposals (RFP) 75N91021R00003 "Preclinical Toxicology of Small Molecule Drugs Developed for Cancer and Other Indications" NOT-CA-21-012 NCI Nov 04 2020 N/A NCI expects to release a Request for Proposals (RFP 75N91020R00003) for conducting toxicology studies.
Pre-Solicitation Notice: Preclinical and Translational Vaccine Development for HIV and Other Candidate Agents, RFP: 75N93019R00023 NOT-AI-20-041 NIAID Apr 07 2020 N/A Pre-Solicitation Notice: Preclinical Translational Vaccine Development HIV Other Candidate Agents, RFP: 75N93019R00023 Notice Number: NOT-AI-20-041 Key Dates Release Date: 04/07/2020 Related Announcements None Issued National Institute Allergy Infectious Diseases NIAID) Purpose development a safe efficacious preventive HIV-1 vaccine one the highest priorities the National Institute Allergy Infectious Diseases NIAID). NIAID supports portfolio preclinical, translational, clinical research advance HIV vaccine efforts. Division AIDS DAIDS) supports research programs discover novel vaccine strategies, assess correlates immunogenicity of protections elicited experimental vaccines provides infrastructure the manufacturing testing novel products. achieve goal, Government anticipates awarding Indefinite Delivery/Indefinite Quantity IDIQ) contracts multiple Contractors meet overall qualifications individual Task Areas. are current single-award IDIQ contracts provide preclinical services HIV Vaccine efforts ranging initial product discovery through full current Good Manufacturing Practices CGMP) manufacturing readiness clinical trials and/or product licensure. Contract No. HHSN272201700010I, Advanced BioScience Laboratories, Inc. ABL), entitled “NIAID Preclinical Development Support” awarded June 2017 a single award IDIQ type contract a period seven years 6/10/2017 through 6/9/2024) a maximum quantity 318,500,000.00. Contract No. HHSN272201600011I, the International AIDS Vaccine Initiative IAVI), entitled “NIAID Process Analytical Support Development HIV Vaccines” awarded July 2016 a single-award IDIQ type contract a period seven years 7/15/2016 through 7/14/2023) a maximum quantity 98,587,183.00 current Contractors provided preclinical services including: manufacturing feasibility assessments, analytical characterization method development, audits, regulatory documentation, process development current Good Manufacturing Practices CGMP) manufacturing, safety immunogenicity studies. Additional services included project management, technical support, quality assurance, product shipping storage, document management. NOTE: Task Area G, Scientific, Quality, Regulatory Support Services, set aside small business concerns only. Proposals received others be considered non-responsive. North American Industry Classification System NAICS) code this acquisition 541715 a size standard 1,000 employees. purpose this solicitation to award multiple IDIQ contracts support full range activities preclinical translational support services initial product discovery through full CGMP) manufacturing readiness clinical trials and/or product licensure. Changes the contract requirements previous IDIQ single-award competitions include of multiple award structure incorporating activities currently found the Essential Core Activities Task Area each Task Order the new awards. Project requirements Contractor shall provide NIAID a broad flexible range capabilities are required preclinical translational development support promising vaccines related products HIV other candidate agents. Contractor shall provide support services needed all stages process product development, small-scale production, preclinical testing documentation leading Investigational New Drug IND) submissions Phase I, II, III clinical testing. capabilities allow NIAID rapidly efficiently address development production gaps. contract support tasks the following areas: Research Development Product Storage Shipping Task Area A) Safety Immunogenicity Studies Task Area B) Feasibility Studies Early Manufacturability Assessments Task Area C) Analytical Characterization Method Development Task Area D) Process Development, CGMP Manufacturing, Stability Task Area E) Fill-Finish, Packaging, Labeling Task Area F) Scientific, Quality, Regulatory Support Services Task Area G) contracts be primarily used support activities related HIV vaccine s) other candidate agents. However, NIAID programs initiate Task Orders under contracts necessary help accomplish mission. A. GENERAL TASK ORDER REQUIREMENTS following requirements shall apply specific Task Orders, needed. Individual Task Orders include requirements appropriate the Task: 1. Within 30 calendar days initiation a Task Order, provide the Contracting Officer’s Representative COR): a. Project Plan key development objectives milestones, proposed timelines achieving Task Order objectives milestones, task-linked budgets, overall high-level steps necessary define, prepare, coordinate, integrate various activities successful execution the Task Order; b. plan manage Intellectual Property IP) may pre-exist will developed during performance the work, including assignment such IP rights, obtaining concurrence the interested parties, maintenance security confidential and/or proprietary data. plan shall include coordination third-party providers proprietary products data through Task Order Material Transfer Agreements MTAs), needed; c. Contractor all subcontractors/consultants be required provide access any Subject Inventions using third-party proprietary materials, reagents, specimens, products data to maintain confidentiality proprietary data provided them a result the contract; d. plan disposition data products developed under Task Orders consultation the COR; e. Quality Management Plan consisting of, a minimum, following: acceptance criteria each deliverable, procedures process controls each deliverable, roles responsibilities personnel involved, assurance the established procedures processes followed. 2. PROJECT MANAGEMENT Contractor shall: a. Provide implement overall project, technical, quality management successfully coordinate, communicate, integrate, perform activities. b. Assist coordination shipments needed. Receive, retrieve, package, ship products various domestic international locations under optimal shipping conditions maintain product integrity under CGMP conditions as otherwise directed the COR. Packaging shipping shall adhere U.S. and/or international standards appropriate. Products should stored prior shipment appropriate temperatures conditions. c. Participate meetings provide support organize coordinate meetings. d. Subcontract Award Management: Provide acquisition management services related the award management subcontracts consultant services follows: 1) Research identify qualified consultants contractors. 2) required, develop solicitations include Statement Work, milestones, deliverables reporting requirements well evaluation criteria. 3) Upon receipt proposals, perform cost technical analyses proposals received. Provide of information support selection award the Contracting Officer CO) request subcontract. CO must consent the subcontract prior the Contractor entering an agreement the subcontractor. 4) Solicit, execute manage subcontracts, including financial monitoring, tracking deliverables reporting requirements well subcontractor performance achievement milestones. 5. 5) Deliver monthly reports progress expenditures the COR. 5) period performance each subcontract cannot exceed period performance the Task Orders. e. Provide operation administration documents, such meeting agendas, meeting minutes, project timelines. Contractor shall provide meeting agendas least 1 business day advance meetings. Contractor shall provide meeting minutes more 2 business days following meeting. Meeting minutes shall include relevant information such as: key discussion points, decisions, action items corresponding due dates. f. Provide upload the NIAID electronic Report Deliverable Submission eRDS) Site electronic progress reports a schedule specified individual Task Orders provide ad hoc reports requested the COR. 3. QUALITY ASSURANCE/QUALITY CONTROL. Contractor shall: a. Provide Quality Assurance Unit QAU) is independent other operations the Contractor, assure products services in compliance U.S., Federal, State, local government International regulations, applicable. b. Provide Quality Assurance/Quality Control QA/QC) oversight the activities the Contractor’s site and/or Subcontractor’s sites. QA/QC infrastructure must include Standard Operating Procedures SOPs) establishing maintaining QA/QC processes approaches/methods document, identify source s) and address QA/QC-related problems deviations they occur, well recommendations the resolution, correction, prevention problems deviations. 4. Provide support a wide range QA related document development, maintenance, submission. 5. PERSONNEL PHYSICAL INFRASTRUCTURE. required all studies conducted under Task Areas, Contractor shall: a. Provide safe biocontainment facilities resources conduct work hazardous biological materials compliance the Biosafety Microbiological Biomedical Laboratories BMBL), 5th Edition. b. Where applicable, address conflicts between biosafety clean facility requirements. 6. ACQUISITION, CARE, HOUSING ANIMALS required all animal studies conducted under Task Areas, Contractor shall: a. Acquire, necessary, sufficient numbers animals carry the specific task order. decision which animal species, ages, sexes be used any requirements Specific-Pathogen Free SPF) animals shall made jointly the COR the Contractor, the COR having final approval. b. House maintain animals well-equipped facilities Association the Assessment Accreditation Laboratory Animal Care AAALAC) International Accreditation the equivalent. c. Comply all applicable laws, policies, guidelines regarding care use laboratory animals, including Public Health Policy PHS) Policy the Human Care Use Laboratory Animals. d. Provide the COR the Contracting Officer CO) verification Office Laboratory Animal Welfare OLAW) Assurance Institutional Animal Care Use Committee IACUC) approval protocols be performed, prior commencing any work involving laboratory animals. 1) activities supporting specific regulatory requirements shall conducted compliance Good Laboratory Practice GLP; 21 CFR 58), CGMP; 21 CFR 210-22, International Conference Harmonization ICH) guidelines, other local, state, federal, non-U.S. product quality development regulations, required. FDA submissions, shall require performance studies a level quality is sufficient incorporation pre-Investigational New Drug IND), IND, New Drug Application NDA) documents. Although studies support product development outside regulatory requirements i.e. non-GLP non-CGMP) also performed, resulting data processes shall well-documented of sufficient quality be acceptable inclusion an IND NDA filing. 2) Contractor shall upload project deliverables NIAID’s electronic document repository a monthly basis. NIAID provide Contractor access a central document storage retrieval system upload documents. 7. TECHNICAL REPORTS DELIVERABLES Deliver the Government its designee requested the COR following upon completion a study under Task Order applicable: a. Any initial product the Task Order, such vaccine, adjuvant, assay, other deliverable, including product associated data; b. products candidate agents, including master cell banks, Bulk Drug Substance BDS), Drug Product DP), such CGMP quality pilot lots, any products under Task Order; c. Labeled inventoried paper files electronic files covering aspects process development detailed manufacturing information all product(s) under Task Order; d. data obtained efficacy studies, including non-proprietary animal model data; e. complete list accurate updated information regarding design, development production including pertinent Contractor activities, computerized data files, original data), any related information such the Chemistry, Manufacturing Controls CMC) section IND, cross-reference Biologic Master File BMF); f. complete list accurate updated information subcontract activities; g. Government-owned equipment property, requested the COR. B. DESCRIPTION INDIVIDUAL TASK AREAS Independently not an agent the Government, Contractor shall furnish the necessary services, qualified personnel, materials, equipment, facilities, otherwise provided the Government, needed perform activities outlined each the following Task Areas to carry all requirements the contract the time contract award. TASK AREA A: RESEARCH DEVELOPMENT PRODUCT STORAGE SHIPPING 1. Scope Task Area A: Task Area includes shipment storage research development products such CGMP non-CGMP preclinical, nonclinical, clinical products agents. 2. Requirements Task Area A: Contractor shall: a. Manage perform receipt, storage, retrieval, packaging shipping research development products, compliance CGMP regulations clinical material. Store quarantined material. Contractor also shall manage perform receipt, storage, retrieval, packaging shipping non-CGMP products required. b. Retrieve, receive, package, ship research development products various domestic international locations under optimum shipping conditions maintain CGMP-product integrity. Packaging shipping shall adhere U.S. international standards required. c. Provide primary secondary labeling label overwrapping related activities requested the COR. TASK AREA B: SAFETY IMMUNOGENICITY STUDIES 1. Scope Task Area B: purpose this Task Area to provide support testing HIV products other candidate agents clinical studies. Support include vitro, ex vivo, in vivo studies small animal models and, necessary, Non-Human Primates NHP). Assays include testing safety immunogenicity. 2. Requirements Task Area B: Contractor shall: a. Manage perform safety immunogenicity studies conduct tasks accordance all applicable current international, federal, state, local laws, codes, ordinances regulations, well all U.S. Public Health Service Safety Health provisions. studies shall performed appropriate quality oversight meet applicable regulatory requirements. b. Test product(s), safety, potency immunogenicity both cellular humoral) using vitro, ex vivo e.g. explant tissue assays), and/or vivo studies small animals and, necessary, NHP. Conduct reproductive toxicology testing needed. Integrate production testing activities perform tests required regulatory agencies, as requested the COR, prior clinical and IND Master File submission. required, studies shall performed accordance GLP regulations 21 CFR 58) ICH guidelines, unless otherwise specified the COR. Although NIAID anticipates animal studies not necessarily conducted under GLP, processes resulting data must well- documented of appropriate quality be included regulatory filings. c. Develop perform analytical methods support vitro, ex vivo, and/or vivo safety, pharmacokinetic PK) pharmacodynamic PD) studies, other preclinical toxicological evaluations. Produce acquire reagents needed. assays processes used shall validated implemented appropriate QA QC standards. d. Perform preclinical immunogenicity evaluation products other agents. e. Evaluate data resulting the studies provide technical project updates intervals in formats designated the COR in Task Order SOW. Perform preclinical safety evaluation products be tested, including: 1) Systemic toxicity. Preclinical studies shall include dose-ranging studies systemic toxicity well toxicity potential target organs, including hematopoietic immune systems; 2)Local site reactivity studies include detailed clinical observations histological evaluation tissue the injection application site, other visible lesions biopsies term necropsy samples; 3) Biodistribution Integration. the case DNA some vector-borne vaccines, studies have be performed determine biodistribution the product. integration analysis shall performed, the product persists above threshold levels a tissue; 4) Genetic toxicity. the case DNA vector-borne vaccine candidates other products, pivotal GLP preclinical studies shall focus assessment the potential the nucleic acid vaccine recombine endogenous host DNA sequences integrate host chromosomes. Studies designed address potential integration shall the most sensitive methods available; 5) Tumorigenicity studies. be appropriate under certain conditions; example, the preclinical genetic testing demonstrates evidence integration activity and/or broad tissue distribution; 6) Reproduction toxicity studies. Shall performed prior the of products pregnant women. Such studies shall include fertility, general reproductive performance, teratogenicity developmental toxicity; 7) Evaluation the safety adjuvants included product formulation; 8) Any studies required regulatory requirements. f. Provide the COR to COR-designated third party, data, information reports required the writing submission the Chemistry, Manufacturing Controls CMC) information, ICH Quality documents, Master File, all documents related pre-IND IND submissions for submission regulatory authorities. Provide CMC section pre-IND IND documentation directed the COR. Provide documentation all regulatory submissions using appropriate formats submission Regulatory Agencies such the FDA other non-U.S. regulatory authorities. g. Retain appropriately store records specimens were analyzed prepare reports per GLP guidance TASK AREA C: FEASIBILITY STUDIES EARLY MANUFACTURABILITY ASSESSMENTS 1. Scope Task Area C: purpose this Task Area to assess provide recommendations products processes developed testing HIV products other candidate agents specimens the following attributes, such as: feasibility design, development, support assessment early manufacturability, transfer product attributes characteristics, development potency assays, short-term stability. 2. Requirements Task Area C: Contractor shall perform Feasibility Studies Early Manufacturability Assessments the development products test HIV vaccine other candidate agents clinical trials. Specifically, Contractor shall: a. Assess current status overall scientific feasibility the studies be performed under Task Order. b. Review relevant documents related the project’s history, including current scientific documents related the project, such laboratory notebooks, publications, any ancillary documentation, including regulatory documentation. c. Assess early manufacturability. Support transfer product attributes activities perform pilot studies needed. d. Assess traceability all reagents the requirements QA, needed. e. Assess advise the current status overall scientific feasibility the project performing following: 1) After review, provide product development history, including current scientific documents related the project, laboratory notebooks, publications, any ancillary documentation regulatory documentation; 2) Provide manufacturing feasibility traceability all study reagents; 3) Complete, provide guidance, and/or assist transfer activities product attributes characteristics; 4) Provide financial feasibility the proposed project; 5) Provide gap analysis risk assessments. f. Develop Product Development Plans PDP) and/or feasibility studies candidate products directed the COR. Plans shall, a minimum, include regulatory, pre-clinical, non- clinical, clinical, manufacturing activities be undertaken a product. g. Provide feasibility study details included specific Task Orders. h. Perform additional requirements related the PDP described specific Task Orders. i. Manufacture feasibility lots each formulation quantities appropriate confirm third- party formulation methods. feasibility lots shall prepared a scale appropriate scale-up the target batch size. j. Before completion the Task Order, prior a date has discussed determined the COR, Contractor shall deliver manufactured feasibility lots target batches each formulation all related documentation. TASK AREA D: ANALYTICAL CHARACTERIZATION METHOD DEVELOPMENT 1. Scope Task Area D: Task Area support activities the development analytical methods product characterization optimization, QC, product release stability program through final formulation, or without adjuvants. Task Area includes performance assays needed product characterization, support phases product development to fulfill regulatory requirements directed the Task Order. 2. Technical Requirements Task Area D: services include analytical method development, method transfer validation, and/or performance the method appropriate QA oversight meet applicable regulatory requirements. Specifically, Contractor shall: a. Develop acquire methods evaluate both structure function HIV vaccine other candidate agents, assure products maintain key product attributes through stages production, including upstream, downstream through final formulation or without adjuvant s); b. Manage, develop conduct analytical characterization methods assess physicochemical structure biological activity HIV immunogens other vaccine candidates agents. Methods include cryo-electron microscopy, Surface Plasmon Resonance SPR) and/or Biolayer Interferometry BLI) measure affinity protein antigens monoclonal antibodies and/or CD4, analysis glycosylation patterns, analysis higher order structures Size-Exclusion Chromatography-Multi Angle Light Scattering SEC-MALS), Mass Spectrometry MS); c. Develop evaluate novel methods suitability product characterization QC assays: 1) Ensure methods developed QC purposes the required level qualification/validation the intended phase development International Council Harmonization ICH) Q6B ICH Harmonized Tripartite Guideline “Specifications: Test Procedure Acceptance Criteria Biotechnological/Biological Products” guidance developing applying analytical methods biological products); 2) Ensure assays supported appropriate scientific rationale are appropriately documented based guidance FDA other regulatory agencies; d. Develop and/or provide assays reagents: 1) Develop and/or provide assays evaluation products cells and/or tissues relevant models/species. 2) Develop relevant diagnostic immunological assays may include following: a) Quality testing reagents animal model parameters, appropriate; b) Development positive, negative, sham control samples; c) Optimization assays; d) Qualify and/or validate, requested the COR, assays reagents; e) studies explore whether new assays procedures meaningful the intended purpose directed the COR; f) Acquire, produce expand reagents needed support vivo, ex vivo in vitro assays after receiving approval the COR. Contractor develop produce necessary reagents either de novo from pre-existing reagents. e. Method Development, specifically, Contractor shall: 1) Develop protocols all vitro, ex vivo, in vivo studies, needed; 2) Develop perform analytical methods support vitro, ex vivo in vivo safety, pharmacokinetic pharmacodynamic studies, other preclinical clinical evaluations; 3) Provide analytical services required performance in vitro, ex vivo, in vivo safety efficacy studies; 4) Develop perform analytical methods characterize formulatory components proposed formulations support manufacturing process development, product characterization, release, stability, identity, homogeneity, other preclinical clinical evaluations. TASK AREA E: PROCESS DEVELOPMENT, CGMP MANUFACTURING, STABILITY 1. Scope Task Area E: Contractor shall provide NIAID a broad flexible range feasibility studies determine manufacturability products, process product development, product characterization, CGMP manufacturing, optimization services HIV vaccine candidates other agents support preclinical, nonclinical, clinical studies. services range initial product discovery production activities required support clinical trials and/or product licensure. 2. Requirements Task Area E: Specifically, Contractor shall carry tasks the following areas: Feasibility Studies Process Development Generate materials suitable IND-enabling studies CGMP Manufacture or without Fill-Finish Stability Program a. PROCESS DEVELOPMENT Contractor shall conduct following types activities support process development fulfill regulatory requirements directed the Task Order SOW: 1) Process development, process transfer validation, and/or performance the process. 2) Analytical method development and/or performance the method. 3) specific activities support this task area required relevant regulatory agencies advance products clinical testing. 4) Contractor shall: a) Perform full process product development the candidate product: scalable upstream downstream production purification activities, product characterization, optimization testing, formulation activities, stability studies technology transfer. may at pilot scale, engineering scale, CGMP manufacturing; b) Construct, screen, optimize various products enhanced stability, immunogenicity, expression well other characteristics directed specific Task Orders; c) Produce establish Master Cell Banks MCB) Working Cell Banks WCB) Master Viral Bank MVB) well-characterized Research Cell Banks RCB) Research Viral Banks RVB), respectively, directed; d) Characterize vaccine products, viral vectors, other candidate agents; e) Design develop protocols all vitro, ex vivo, in vivo studies provide the COR, directed; f) Develop perform analytical methods characterize vaccine products other products, other preclinical clinical evaluations. Develop provide QA/QC assays in-process products; g) Provide analytical services required performance in vitro, ex vivo, in vivo safety efficacy studies; h) Generate reagents reference standards, develop assays, perform analytics needed in-process testing release products such potency immunogenicity; Evaluate adjuvants, delivery vehicles, routes administration candidate vaccines, needed; i) Provide technology transfer packages. Manage successful technology transfer least pilot engineering scale. Develop provide detailed project plan, budget, Gantt chart early-to-late-stage process development manufacture products prior undertaking reagent-grade pilot-lot CGMP production. project plan shall include written SOPs all steps the production purification process are used pilot production. 5) Although NIAID anticipates all studies not necessarily conducted under GLP, processes resulting data shall well-documented of sufficient quality be acceptable inclusion regulatory filings IND/NDA). b. CGMP MANUFACTURING FILL-FINISH OPERATIONS Contractor shall perform CGMP product manufacturing, analytical support CGMP operations, fill-finish Bulk Drug Substance BDS) HIV products other candidate agents produce preclinical clinical trial material, fulfill regulatory requirements directed the Task Order SOW. Specifically, Contractor shall: 1) Manufacture products under CGMP conditions suitable scale include consistency lots needed, conducting preclinical, stability, toxicity, biodistribution, clinical studies verifiable safety, purity potency the product; 2) Provide analytical services support product manufacture; 3) Qualify validate processes assays implement appropriate QA QC standards all services provided; 4) Perform audits subcontractors vendors, assure facilities all planned procedures meet FDA-required GLP CGMP standards; Host NIAID participants these audits, and/or host NIAID-led audits needed as requested the COR; 5) Provide the necessary documentation guidance required assemble CMC section an IND submission; 6) Retrieve, receive, store, ship record products any materials associated the products; 7) Perform fill-finish operations CGMP manufactured candidates including vialing, packaging labeling, compliance FDA, EMA, other regulatory agency regulations. Perform release testing provide Certificate Analysis CoA) Certificate Compliance CoC) needed. Establish, implement oversee product- specific stability programs comply FDA, ICH other non-U.S. regulatory guidelines CGMP-manufactured products other candidate agents intended human use; 8) Develop detailed project plan budget, consultation the COR, the manufacture each product prior undertaking CGMP production. project plan shall include written SOPs, list(s) SOPs, protocols are established followed all steps the sterile aseptic production purification process CGMP manufacture well the fill-finish the product; 9) Provide information pertaining the composition, manufacture, quality control the product, appropriate, particular investigations carried under IND; 10) Retain records, samples, histology/microscopy slides, indicated under GLP CGMP guidelines, provide to COR upon request; 11) Produce acquire any reagents necessary testing evaluating immune responses products; 12) Establish, implement oversee formulation studies manufactured vaccines and/or products requested the COR; 13) Deliver the Government, upon request, any initial product the Task Order, such a vaccine, adjuvant, assay, other deliverable, including product’s associated data. c. STABILITY PROGRAM 1) Design perform stability testing program BDS or Drug Products DP), if needed, conduct pre-formulation and/or formulation studies tests vaccine candidates drug product-adjuvant interactions, combinations thereof. 2) Contractor shall perform stability testing BDS DP based long-term, real-time real-conditions storage. stability testing help establish recommended storage conditions, retest periods, shelf life the candidate products. TASK AREA F: FILL-FINISH, PACKAGING, LABELING 1. Scope Task Area F: purpose this Task Area to perform fill finish including packaging labeling products other agents. 2. Requirements Task Area F: Specifically, Contractor shall: a. Perform fill-finish operations, packaging labeling: Conduct aseptic fill-finish candidate products pre-clinical, stability, clinical studies. Fill-finish operations shall include necessary in-process release testing, qualified assays, appropriate components, formulation, vialing, labeling, packaging, storage. Final fill-finish operations be preceded Contractor’s assistance the design execution pre-formulation formulation development studies and/or supporting media fills needed. these operations shall take place CGMP-compliant facilities methods meet standards products appropriate use clinical trials, described the Code Federal Regulations CFR) “Sterile Drug Products Produced Aseptic Processing—Current Good Manufacturing Practice”, “Current Good Manufacturing Practice Finished Pharmaceuticals” 2l CFR parts 210 211, other non-U.S. regulatory agencies. b. Ensure feasibility appropriateness the proposed plans operating procedures receipt, storage designated temperature, custom blending, and/or formulation studies using BDS, vialing, labeling, retrieval, packaging, shipping filled products, materials, specimens required fulfill SOW. c. Provide formal, written procedures, SOPs, draft final batch records related fill-finish, any bridging qualification studies, DP testing, product release specifications, facilities- compliance, validated sterilization components processes, container-attributes container-closure information. d. Perform labeling CGMP-filled candidate vaccine products needed, accordance CFR Title 21, Vol 5, Part 312. e. Perform release testing provide CoC CoA, needed. f. Conduct specific activities related fill-finish, packaging labeling advance products clinical testing per FDA other non-US regulatory guidance. TASK AREA G: SCIENTIFIC, QUALITY, REGULATORY SUPPORT SERVICES TASK AREA SET ASIDE SMALL BUSINESS CONCERNS above) 1. Scope Task Area G: scope this Task Area to provide broad scientific/technical, QA/QC, Regulatory, other clinical related research support products other candidate agents directed the COR. 2. Requirements Task Area G: Specifically, Contractor shall: a. SCIENTIFIC TECHNICAL SUPPORT 1) Provide scientific technical support areas such as: temperature excursions during shipping storage, product integrity, Out-of-Specification OOS) test results, Compliance Events CE), reports particulate matter BDS, DP other materials including adjuvants, evaluation interpretation data, as requested the COR. 2) Provide subject matter expertise requested the COR strategic technical planning other Task Areas such cell line development, harvest yield optimization, purification, stabilization, formulation, adjuvants, process refinement, existing, novel emerging platform technology development, compliance issues. b. QUALITY ASSURANCE/QUALITY CONTROL QA/QC) SUPPORT 1) Provide Audit Support: a) Conduct manage facility audits and/or technical audits foreign domestic vendors. Audits shall consider compliance with: i. Domestic non-domestic laws regulations, ii. FDA/European Medicines Agency EMA) regulations guidance, including those required meet CGMP, GLP guidance, GCP standards and/or applicable guidance, iii. NIAID policies the terms the contract. b) Specifically, scope the audit include activities such as: organization personnel, buildings facilities, equipment, control components BDS Substance DP containers closures, production process systems controls, packaging labeling control, holding distribution, laboratory controls, returned salvaged drug products, testing facilities operation, test control articles, protocols and conduct a non-clinical laboratory toxicity study, records reports, disqualification testing facilities. c) Provide the COR audit plan within ten 10) business days a request an audit. Provide the COR draft the audit report within ten 10) business days audit completion. Contractor shall submit final audit report the COR within twenty-one 21) business days audit completion provide prioritized recommendations address observations and/or deficiencies identified the report. Upon approval the report the COR, Contractor shall provide copy the audited organization’s representative. d) Establish maintain Conflict Interest COI) policy SOP addresses reporting chain independence auditors other contract related staff independence the sites be audited. COR review draft COI SOP provide comments the Contractor within ten 10) business days receipt. Provide final COI SOP within twenty 21) business days Task Order award date. Report any identified conflicts interest prior any site visit audit. 2) Provide quality support guidance requested the COR. c. REGULATORY SUPPORT Document preparation submission: consultation the COR, obtain compile information necessary submission regulatory documents the U.S. non-domestic regulatory authorities. 1) Compile assemble documentation required the pre-IND, IND other regulatory submissions, a format appropriate submission the FDA, EMA, other regulatory agencies, upon request the COR. Compile provide CMC section pre-IND IND documentation requested the COR. Participate discussions the FDA non-U.S. regulatory agencies required. 2) Provide additional submissions amendments the COR to third-party designated the COR, necessary successful filing the IND, comparable non- U.S. approval documents. Prepare environmental assessment described 21 CFR 25.31, required. 3) Review documentation requested the COR, provide regulatory support related all aspects the product pathway vaccine candidates other agents: safety immunogenicity studies, process product development, manufacturing, fill/finish, stability. 4) Provide regulatory support services directed the COR. Anticipated Period Performance NIAID anticipates multiple Indefinite Delivery/Indefinite Quantity IDIQ) contract awards the Base contracts be or June 9, 2021. ordering period these contracts be June 9, 2021 through June 8, 2028. Contractors not required make any deliveries under contracts after June 8, 2031. Government anticipates awarding following number Task Orders year. list provided indicate general scope the work be performed should considered estimate only. Task Area Title Estimated No. Task Orders Per Year Research Development Product Storage Shipping 2 awards be for 7 year period performance B Safety Immunogenicity Studies 3 C Feasibility Studies & Early Manufacturability 2 D Analytical Characterization Method Development 2 E Process Development, CGMP Manufacturing Stability 5 F Fill-Finish Labeling 4 G Scientific, Quality Regulatory Support Services 1 Immediately, upon award the Base contracts this multiple award IDIQ, Government anticipates awarding Task Orders follows: Task Order 1, Research Development Product Shipping Storage anticipate awarding cost-reimbursement, level effort/term type Task Order. period performance this Task Order be June 9, 2021 through June 8, 2022. requirement be delivery 1.45 Full Time Equivalents FTEs) the base period Year 1). Options extend term the Task Order be included the Task Order award. Assume the scope types activities outlined herein i.e., year of Task Order) be continued each succeeding annual Task Order period to 7 total years. Options extend term exercised, Contractor shall provide 1.45 FTEs per year Options 1 6. Please note the number FTEs inclusive subcontractor consultant effort. Level Effort: Below the level effort required this Task Order. level effort stated terms FTEs. labor mix provided an estimate is meant be restrictive. Contractor propose different labor mix carrying the SOW the Task Order must meet total FTE requirement. Labor Category Estimated FTEs/Year Principal Investigator 0.01 Project Manager 0.40 Professionals 0.09 Technical Support 0.95 Total 1.45 Offerors respond one Task Area only, several Task Areas, to Task Areas. Task Area G, Scientific, Quality Regulatory Support Services, set aside small business concerns only. Any responsible offeror submit proposal will considered the Agency. RFP be available electronically on/about April 10, 2020 may accessed through beta.SAM.gov. notice does commit Government award contract Task Order. collect calls be accepted. facsimile transmissions be accepted. this solicitation, NIAID requires proposals be submitted via NIAID electronic Contract Proposal Submission eCPS) website. directions using eCPS, to website https://ecps.nih.gov then click “How Submit.” Submission proposals facsimile e-mail not acceptable. Inquiries Please direct inquiries to: Patrick Finn Contracting Officer AIDS Research Contracts Branch, Office Acquisitions Division Extramural Activities National Institute Allergy Infectious Diseases National Institutes Health, DHHS 5601 Fishers Lane, Room 3C29, MSC 9821 Bethesda, MD 20892-9821 Express Mail, change zip code 20852 Telephone: 240-669-5401 Email: patrick.finn@nih.gov John R. Manouelian Contracting Officer AIDS Research Contracts Branch, Office Acquisitions Division Extramural Activities National Institute Allergy Infectious Diseases National Institutes Health, DHHS 5601 Fishers Lane, Room 3C31, MSC 9821 Bethesda, MD 20892-9821 Express Mail, change zip code 20852 Telephone: 240-669-5152 Email: manouelj@niaid.nih.gov
Pre-Solicitation Notice: NIAID Specimen Repository, RFP: 75N93020R00006 NOT-AI-20-033 NIAID Feb 10 2020 N/A Pre-Solicitation Notice: NIAID Specimen Repository, RFP: 75N93020R00006 Notice Number: NOT-AI-20-033 Key Dates Release Date: February 10, 2020 Related Announcements None Issued National Institute Allergy Infectious Diseases NIAID) Purpose National Institute Allergy Infectious Diseases NIAID), National Institutes Health NIH) conducts supports epidemiological clinical research infectious diseases. of large clinical epidemiological studies funded NIAID collect biologic specimens subjects ongoing future studies. collection storage these specimens many different research studies a single repository a valuable resource which researchers rapidly validate scientific hypotheses algorithms clinical decision-making. Comprehensive well-maintained specimen collections coupled epidemiologic data facilitated research the pathogenesis HIV disease, development novel drug approaches, HIV prevention studies potential microbicides vaccines, approaches eliminating HIV reservoirs”. NIAID Specimen Repository NSR), first funded 1988, provides receipt, storage distribution biological specimens received institutions conducting NIAID-sponsored clinical trials observational cohort studies. Presently repository largely houses specimens HIV related clinical trials cohort studies. specimens been collected over years. Selection Study Groups storing specimens the NSR guided scientific priorities NIAID. current NIAID Study Groups storing specimens the NSR are: Women’s Interagency HIV Study WIHS) the Multicenter AIDS Cohort Study MACS), called MACS/WIHS Combined Cohort Study MWCCS); the HIV Vaccine Trials Network HVTN). NSR also maintains specimens other smaller NIAID-sponsored studies have completed. are currently over 8 million specimens the NSR. current contract Precision Bioservices, Inc., Contract No. HHSN272201400037C, expire September 29, 2021. purpose this contract the short, moderate long-term specimen storage domestic international clinical research specimens through receipt, cryopreservation, storage specimens research sites laboratories. Specimens include peripheral blood mononuclear cells, serum, plasma, tissue other bodily fluids substances such cervicovaginal lavage CVL), semen, saliva, urine, feces, autopsy biopsy materials whole blood spots dried filter paper. Contractor shall house, operate manage NIAID Specimen Repository NSR) perform following specific tasks: 1) Follow Federal, State local requirements current best practices the collection, handling, preservation, storage, retrieval distribution biological material scientific research; 2) Manage specimens receive, store maintain specimens); 3) Distribute specimens materials, including packaging, handling, coordinating specimen shipments domestic international sites. 4) Prepare aliquot specimens; 5) Provide research materials; 6) Provide produce additional research materials such immortalized cell lines, DNA cDNA, needed; 7) Withdraw destroy specimens; 8) Maintain high quality, secure information systems allow detailed tracking specimen receipt, processing, storage, inventory distribution, rapid retrieval specimens, storage QA/QC information associated the specimen; 9) Establish maintain Quality Assurance QA) Quality Control QC) Programs; 10) Ensure orderly transition the NIAID Specimen Repository contract initiation at contract expiration, needed; 11) Attend meetings teleconferences the COR. addition, Contractor must: 1) Comply the National Cancer Institute Best Practices Biospecimen Resources 2) Comply The International Society Biological Environmental Repository Best Practices Repositories 3) Perform packaging shipment procedures meet standards biologically hazardous materials Biological Substance Category B, UN3373. Shipments shall comply current standards indicated international, Federal, State, local government regulations, well the International Air Transport Association IATA) Guidance Document Infectious Substances. 4) Handle biological specimens potential known blood borne other potentially infectious pathogens accordance OSHA standards 29 CFR 1910.1030 Biosafety Microbiological Biomedical Laboratories BMBL) 5th Edition CDC Guidelines. is anticipated will a performance-based acquisition a cost reimbursement, term/level effort, type contract be awarded. performance requirement be delivery 20.00 full time equivalents FTEs) per year the base period Year 1) option periods Year 2 through Year 7), may unilaterally exercised the Government. option periods extend term the contract beyond base period up 7 years. addition the services outlined above be provided the base requirement, options additional level effort 1 FTE be exercised the discretion the Government unanticipated increases demand may exercised to 2 times a performance year. Should Government elect exercise options, Contractor shall provide resources stated above. Any responsible offeror submit proposal will considered the Agency. RFP be available electronically on/about February 20, 2020 may accessed through beta.SAM.gov. notice does commit Government award contract. collect calls be accepted. facsimile transmissions be accepted. this solicitation, NIAID requires proposals be submitted online via NIAID electronic Contract Proposal Submission eCPS) website. Submission proposals facsimile e-mail not acceptable. directions using eCPS, to website https://ecps.nih.gov and click How Submit." is anticipated will a performance-based acquisition a cost reimbursement, term/level effort, type contract be awarded. performance requirement be delivery 20.00 full time equivalents FTEs) per year the base period Year 1) option periods Year 2 through Year 7), may unilaterally exercised the Government. option periods extend term the contract beyond base period up 7 years. Duration contract: 7 Years Options be included follows: Term Options Quantity Options Increased Level Effort. Anticipated award date: March 30, 2021 Inquiries Please direct inquiries to: Kim Brookens Contracting Officer AIDS Research Contracts Branch, Office Acquisitions Division Extramural Activities National Institute Allergy Infectious Diseases National Institutes Health, DHHS 5601 Fishers Lane, Room 3C46, MSC 9821 Bethesda, MD 20892-9821 Express Mail, change zip code 20852 Direct Phone: 301-761-5140 Email: kim.brookens@nih.gov Michelle L. Scala Contracting Officer/Team Leader AIDS Research Contracts Branch, Office Acquisitions Division Extramural Activities National Institute Allergy Infectious Diseases National Institutes Health, DHHS 5601 Fishers Lane, Room 3C42, MSC 9821 Bethesda, MD 20892-9821 Express Mail, change zip code 20852 Direct Phone: 240-669-5156 Email: mscala@niaid.nih.gov

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