Inactive

Introduction National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) conducts and supports epidemiological and clinical research on infectious diseases. Many... Introduction National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) conducts and supports epidemiological and clinical research on infectious diseases. Many of the large clinical and epidemiological studies funded by NIAID collect biologic specimens from subjects for ongoing and future studies. The collection and storage of these specimens from many different research studies in a single repository is a valuable resource with which researchers can rapidly validate scientific hypotheses and algorithms for clinical decision-making. Comprehensive and well-maintained specimen collections coupled with epidemiologic data have facilitated research on the pathogenesis of HIV disease, development of novel drug approaches, HIV prevention studies of potential microbicides and vaccines, and approaches for eliminating HIV reservoirs” The NIAID Specimen Repository (NSR), first funded in 1988, provides receipt, storage and distribution of biological specimens received from institutions conducting NIAID-sponsored clinical trials and observational cohort studies. Presently the repository largely houses specimens from HIV related clinical trials and cohort studies. The specimens have been collected over many years. Selection of Study Groups storing specimens in the NSR is guided by scientific priorities of NIAID. The current NIAID Study Groups storing specimens in the NSR are: the Women’s Interagency HIV Study (WIHS) and the Multicenter AIDS Cohort Study (MACS), now called the MACS/WIHS Combined Cohort Study (MWCCS); and the HIV Vaccine Trials Network (HVTN). The NSR also maintains specimens from other smaller NIAID-sponsored studies that have been completed. There are currently over 8 million specimens in the NSR. The current contract with Precision Bioservices, Inc., Contract No. HHSN272201400037C, will expire on September 29, 2021. Description The purpose of this contract is the short, moderate and long-term specimen storage of domestic and international clinical research specimens through receipt, cryopreservation, and storage of specimens from research sites or laboratories. Specimens include peripheral blood mononuclear cells, serum, plasma, tissue and other bodily fluids or substances such as cervicovaginal lavage (CVL), semen, saliva, urine, feces, autopsy and biopsy materials and whole blood spots dried on filter paper. The Contractor shall house, operate and manage the NIAID Specimen Repository (NSR) and perform the following specific tasks: 1) Follow all Federal, State and local requirements and current best practices for the collection, handling, preservation, storage, retrieval and distribution of biological material for scientific research; 2) Manage specimens (receive, store and maintain specimens); 3) Distribute specimens and materials, including packaging, handling, and coordinating specimen shipments to domestic and international sites. 4) Prepare and aliquot specimens; 5) Provide research materials; 6) Provide or produce additional research materials such as immortalized cell lines, DNA and cDNA, as needed; 7) Withdraw and destroy specimens; 8) Maintain high quality, secure information systems to allow detailed tracking of specimen receipt, processing, storage, inventory and distribution, rapid retrieval of specimens, and storage of QA/QC information associated with the specimen; 9) Establish and maintain Quality Assurance (QA) and Quality Control (QC) Programs; 10) Ensure an orderly transition of the NIAID Specimen Repository at contract initiation and at contract expiration, as needed; and 11) Attend meetings and teleconferences with the COR. In addition, the Contractor must: 1) Comply with the National Cancer Institute Best Practices for Biospecimen Resources 2) Comply with The International Society of Biological and Environmental Repository Best Practices for Repositories 3) Perform packaging and shipment procedures that meet standards for biologically hazardous materials as Biological Substance Category B, UN3373. Shipments shall comply with current standards as indicated by international, Federal, State, and local government regulations, as well as the International Air Transport Association (IATA) Guidance Document for Infectious Substances. 4) Handle biological specimens with potential or known blood borne or other potentially infectious pathogens in accordance with OSHA standards 29 CFR 1910.1030 and Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition CDC Guidelines. It is anticipated this will be a performance-based acquisition and a cost reimbursement, term/level of effort, type of contract will be awarded. The performance requirement will be the delivery of 20.00 full time equivalents (FTEs) per year for the base period (Year 1) and option periods (Year 2 through Year 7), which may be unilaterally exercised by the Government. The option periods may extend the term of the contract beyond the base period for up to 7 years. In addition to the services outlined above to be provided in the base requirement, options for additional level of effort of 1 FTE may be exercised at the discretion of the Government for unanticipated increases in demand that may be exercised up to 2 times in a performance year. Should the Government elect to exercise these options, the Contractor shall provide resources as stated above. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about February 20, 2020 and may be accessed through beta.SAM.gov. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit." PLEASE SEE THE ATTACHMENT BELOW FOR THE SOLICITATION.

Inactive

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MS... Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821 Duration of contract: 7 Years Options will be included as follows: Term Options and Quantity Options for Increased Level of Effort. Anticipated award date: March 30, 2021 Introduction National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) conducts and supports epidemiological and clinical research on infectious diseases. Many of the large clinical and epidemiological studies funded by NIAID collect biologic specimens from subjects for ongoing and future studies. The collection and storage of these specimens from many different research studies in a single repository is a valuable resource with which researchers can rapidly validate scientific hypotheses and algorithms for clinical decision-making. Comprehensive and well-maintained specimen collections coupled with epidemiologic data have facilitated research on the pathogenesis of HIV disease, development of novel drug approaches, HIV prevention studies of potential microbicides and vaccines, and approaches for eliminating HIV reservoirs” The NIAID Specimen Repository (NSR), first funded in 1988, provides receipt, storage and distribution of biological specimens received from institutions conducting NIAID-sponsored clinical trials and observational cohort studies. Presently the repository largely houses specimens from HIV related clinical trials and cohort studies. The specimens have been collected over many years. Selection of Study Groups storing specimens in the NSR is guided by scientific priorities of NIAID. The current NIAID Study Groups storing specimens in the NSR are: the Women’s Interagency HIV Study (WIHS) and the Multicenter AIDS Cohort Study (MACS), now called the MACS/WIHS Combined Cohort Study (MWCCS); and the HIV Vaccine Trials Network (HVTN). The NSR also maintains specimens from other smaller NIAID-sponsored studies that have been completed. There are currently over 8 million specimens in the NSR. The current contract with Precision Bioservices, Inc., Contract No. HHSN272201400037C, will expire on September 29, 2021. Description The purpose of this contract is the short, moderate and long-term specimen storage of domestic and international clinical research specimens through receipt, cryopreservation, and storage of specimens from research sites or laboratories. Specimens include peripheral blood mononuclear cells, serum, plasma, tissue and other bodily fluids or substances such as cervicovaginal lavage (CVL), semen, saliva, urine, feces, autopsy and biopsy materials and whole blood spots dried on filter paper. The Contractor shall house, operate and manage the NIAID Specimen Repository (NSR) and perform the following specific tasks: 1) Follow all Federal, State and local requirements and current best practices for the collection, handling, preservation, storage, retrieval and distribution of biological material for scientific research; 2) Manage specimens (receive, store and maintain specimens); 3) Distribute specimens and materials, including packaging, handling, and coordinating specimen shipments to domestic and international sites. 4) Prepare and aliquot specimens; 5) Provide research materials; 6) Provide or produce additional research materials such as immortalized cell lines, DNA and cDNA, as needed; 7) Withdraw and destroy specimens; 8) Maintain high quality, secure information systems to allow detailed tracking of specimen receipt, processing, storage, inventory and distribution, rapid retrieval of specimens, and storage of QA/QC information associated with the specimen; 9) Establish and maintain Quality Assurance (QA) and Quality Control (QC) Programs; 10) Ensure an orderly transition of the NIAID Specimen Repository at contract initiation and at contract expiration, as needed; and 11) Attend meetings and teleconferences with the COR. In addition, the Contractor must: 1) Comply with the National Cancer Institute Best Practices for Biospecimen Resources 2) Comply with The International Society of Biological and Environmental Repository Best Practices for Repositories 3) Perform packaging and shipment procedures that meet standards for biologically hazardous materials as Biological Substance Category B, UN3373. Shipments shall comply with current standards as indicated by international, Federal, State, and local government regulations, as well as the International Air Transport Association (IATA) Guidance Document for Infectious Substances. 4) Handle biological specimens with potential or known blood borne or other potentially infectious pathogens in accordance with OSHA standards 29 CFR 1910.1030 and Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition CDC Guidelines. It is anticipated this will be a performance-based acquisition and a cost reimbursement, term/level of effort, type of contract will be awarded. The performance requirement will be the delivery of 20.00 full time equivalents (FTEs) per year for the base period (Year 1) and option periods (Year 2 through Year 7), which may be unilaterally exercised by the Government. The option periods may extend the term of the contract beyond the base period for up to 7 years. In addition to the services outlined above to be provided in the base requirement, options for additional level of effort of 1 FTE may be exercised at the discretion of the Government for unanticipated increases in demand that may be exercised up to 2 times in a performance year. Should the Government elect to exercise these options, the Contractor shall provide resources as stated above. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about February 20, 2020 and may be accessed through beta.SAM.gov. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."

Inactive

Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding:... Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) conducts and supports epidemiological and clinical research on infectious diseases. Many of the large clinical and epidemiological studies funded by NIAID collect biologic specimens from subjects for ongoing and future studies. The collection and storage of these specimens from various research studies in a single repository is a valuable resource with which researchers can rapidly validate scientific hypotheses and algorithms for clinical decision-making. Comprehensive and well-maintained specimen collections coupled with epidemiologic data have facilitated research on the pathogenesis of HIV disease, development of novel drug approaches, HIV prevention studies of potential microbicides and vaccines, and approaches for eliminating HIV reservoirs” The NIAID Specimen Repository (NSR), first funded in 1988, provides receipt, storage and distribution of biological specimens received from institutions conducting NIAID-sponsored clinical trials and observational cohort studies (Study Groups). Presently the repository largely houses specimens from HIV related clinical trials and cohort studies. The specimens have been collected over many years. Selection of Study Groups storing specimens in the NSR is guided by scientific priorities of NIAID. The current NIAID Study Groups storing specimens in the NSR are: the Women’s Interagency HIV Study (WIHS) and the Multicenter AIDS Cohort Study (MACS), now called the MACS/WIHS Combined Cohort Study (MWCCS); and the HIV Vaccine Trials Network (HVTN). The NSR also maintains specimens from other smaller NIAID-sponsored studies. There are currently over 8 million specimens in the NSR. The current contract with Precision Bioservices, Inc., Contract No. HHSN272201400037C, will expire on September 29, 2021. Purpose and Objectives The purpose of this contract is the short, moderate and long-term specimen storage of domestic and international clinical research specimens through receipt, cryopreservation, and storage of specimens from research sites or laboratories. Specimens include peripheral blood mononuclear cells, serum, plasma, tissue and other bodily fluids or substances such as cervicovaginal lavage (CVL), semen, saliva, urine, feces, autopsy and biopsy materials and whole blood spots dried on filter paper. Project Requirements The Contractor shall house, operate and manage the NIAID Specimen Repository (NSR) and perform the following specific tasks: 1) Follow all Federal, State and local requirements and current best practices for the collection, handling, preservation, storage, retrieval and distribution of biological material for scientific research; 2) Manage specimens (receive, store an maintain specimens); 3) Distribute specimens and materials, including packaging, handling, an coordinating specimen shipments to domestic and international sites. 4) Prepare and aliquot specimens; 5) Provide research materials; 6) Provide or produce additional research materials such as immortalized cell lines, DNA and cDNA, as needed; 7) Withdraw and destroy specimens; 8) Maintain high quality, secure information systems to allow detailed tracking of specimen receipt, processing, storage, inventory and distribution, rapid retrieval of specimens, and storage of QA/QC information associated with the specimen; 9) Establish and maintain Quality Assurance (QA) and Quality Control (QC) Programs; 10) Ensure an orderly transition of the NIAID Specimen Repository at contract initiation and at contract expiration, as needed; and 11) Attend meetings and teleconferences with the COR. Performance Requirement and Anticipated Period of Performance It is anticipated this will be a performance-based acquisition and a cost reimbursement, term/level of effort, type of contract will be awarded. The performance requirement will be the delivery of 20.00 full time equivalents (FTEs) per year for the base period (Year 1) and option periods (Year 2 through Year 7), which may be unilaterally exercised by the Government. The option periods may extend the term of the contract beyond the base period for up to 7 years. In addition to the services outlined above to be provided in the base requirement, options for additional level of effort of 1 FTE may be exercised at the discretion of the Government for unanticipated increases in demand that may be exercised up to 2 times in a performance year. Should the Government elect to exercise these options, the Contractor shall provide resources as stated above. Other Important Considerations The Contractor must: Comply with the National Cancer Institute Best Practices for Biospecimen Resources Comply with The International Society of Biological and Environmental Repository Best Practices for Repositories Perform packaging and shipment procedures that meet standards for biologically hazardous materials as Biological Substance Category B, UN3373. Shipments shall comply with current standards as indicated by international, Federal, State, and local government regulations, as well as the International Air Transport Association (IATA) Guidance Document for Infectious Substances. Handle biological specimens with potential or known blood borne or other potentially infectious pathogens in accordance with OSHA standards 29 CFR 1910.1030 and Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition CDC Guidelines. Repository samples are classified as Biological Substance Category B, UN3373. Capability Statement/Information Sought Capability Statements should clearly convey information regarding the respondent’s capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company’s experience and ability to perform this effort that includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 5 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: DUNS. Company Name. Company Address. Company Point of Contact, Phone and Email address Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Kim Brookens, Contracting Officer, at kim.brookens@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify SBSS-75N93020R00006. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00 PM (Eastern Prevailing Time) on December 18, 2019. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”