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SAMDAILY.US - ISSUE OF JULY 26, 2024 SAM #8277
SOURCES SOUGHT

A -- In Vitro Assessments of Antimicrobial Activity

Notice Date
7/24/2024 12:28:33 PM
 
Notice Type
Sources Sought
 
NAICS
541714 — Research and Development in Biotechnology (except Nanobiotechnology)
 
Contracting Office
NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
 
ZIP Code
20892
 
Solicitation Number
75N93024R00024
 
Response Due
8/14/2024 12:00:00 PM
 
Archive Date
08/29/2024
 
Point of Contact
Alexander Beraud, Brian Madgey
 
E-Mail Address
alexander.beraud@nih.gov, brian.madgey@nih.gov
(alexander.beraud@nih.gov, brian.madgey@nih.gov)
 
Description
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 The National Institute of Allergy and Infectious Diseases (NIAID) supports and facilitates research that focuses on understanding, treating and, ultimately, preventing infectious, immunologic, and allergenic diseases that threaten the lives of millions of people.� The NIAID Division of Microbiology and Infectious Diseases (DMID) supports and facilitates research to understand, control and prevent human disease caused by infectious agents.� Basic, applied, and translational research to develop and assess therapeutics, vaccines, and diagnostics are supported through research grants, cooperative agreements, and contracts.� In turn, DMID supports and facilitates these funding mechanisms via an array of resources and services.� These programs include bioinformatics, structural biology, biorepositories, biocontainment facilities, and pre-clinical and clinical translational research resources. https://www.niaid.nih.gov/research/product-development-services� In 2019, fourteen (14) institutions were awarded base contracts under the In Vitro Assessments of Antimicrobial Activity (IVAAA) Indefinite-Delivery / Indefinite-Quantity (IDIQ) contract program. Its overarching goal was to provide broad capability in in vitro methods to evaluate activity of candidate countermeasures against the full range of infectious agents in the purview of DMID. The breadth of the existing contractor pool has enabled a rapid and effective response to emerging threats such as SARS-CoV-2 and other emergency preparedness priorities. The current IDIQ contract program has supported the evaluation of hundreds of candidate countermeasures against bacteria, fungi, and viruses. As such, in response to requests from extramural investigators for early-stage testing of their products, these contracts facilitated critical go/no-go decisions and provided data that permitted advancement of promising countermeasures into further preclinical testing.� Purpose and Objectives NIAID supports nearly all stages of the product development pipeline from in vitro therapeutic evaluation through advanced therapeutic and vaccine testing and manufacturing using multiple support services contracts.� The anticipated solicitation addresses a critical stage in this pipeline by providing an efficient means to assess the therapeutic potential of compounds through in vitro testing.� The overarching goal of the IVAAA program is to provide capability in a broad range of in vitro testing capabilities to assess promising candidate countermeasures against the more than 270 infectious agents and vectors that are within the purview of DMID. In addition to meeting the needs of extramural researchers, it is anticipated that contracts resulting from this solicitation will provide crucial data to be used by NIAID partners at other agencies within the Department of Health and Human Services.� Such data will facilitate the advancement of promising candidate medical countermeasures against priority emerging and bioterror infectious agents to approval or licensure and, in some cases, eventual deposit in the Strategic National Stockpile. NIAID anticipates awarding IDIQ contracts to organizations that have the capabilities required to fulfill the technical requirements of the Task Areas of the anticipated solicitation. Offerors will be considered for contracts only in the Task Area(s) included in their proposal(s), and successful Contractors may compete for task orders only in the Task Area(s) in which they are selected for award.� The Task Areas of the anticipated solicitation are as follows: Task Area A � Bacteria, Fungi, and Toxins Task Area B � Viruses Task Area C � Parasites and Vectors Task Area D � New Techniques to Culture Difficult-to-Grow Pathogens� Project requirements This requirement will enable DMID to provide a broad and flexible range of in vitro assay capabilities for human infectious diseases or diseases of human importance caused by infectious agents, including but not limited to product screening, assay development, and development of improved systems for in vitro culturing of difficult-to-grow pathogens.� These capabilities will allow the NIAID to respond to changing priorities as scientific and public health needs shift, including rapid responses to public health emergencies.� NOTE: In vitro assessments of antimicrobial activity against pathogens, vectors or toxins which only cause disease in animals are not supported, unless these pathogen/animal systems are models for human disease. For the purposes of this solicitation the following definitions apply: Assays � in vitro procedures for determining biological activity of a substance by measuring its effect on an organism, tissue, cell, enzyme or receptor preparation.� In addition, in vitro procedures for determining the concentration, and/or purity of a substance. Products � broadly defined and include therapeutic substances targeting the host or the pathogen (May be used interchangeably with test article). Pathogens � bacteria, viruses, parasites, and fungi. Toxins �products of microbial origin that induce a pathological effect in a host, but are not the microbe itself. Vectors � arthropods (usually insects) or mollusks that carry pathogens from infected to uninfected hosts. Reagents � biochemical, genomic, molecular, cellular, and immunologic materials integral to research on these pathogens, toxins, and vectors.� Anticipated period of performance It is anticipated that multiple award IDIQ contracts will be awarded with a seven-year ordering period. Capability statement/information sought Capability Statements should clearly convey information regarding the respondent�s capabilities including:� (1) staff expertise, including their availability, experience, and formal and other training; (2) current in-house capability and capacity to perform the work; (3) prior completed projects of similar nature; and (4) institutional/corporate experience and management capability. Interested respondents must submit a capability statement describing their company�s experience and ability to perform this effort that includes the following: ����� A summary list of similar work previously performed; ����� The professional qualifications and specific experience of staff who may be assigned to the requirement; ����� Resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; ����� Documented adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity; ����� Documented adequacy and appropriateness of proposed organization and staffing to ensure efficient planning, initiation, implementation, conduct, and completion of all activities, including plans for communication and sharing of research resources; ����� A general description of the facilities and other resources necessary to conduct work with hazardous biological materials in compliance with all Federal and NIH regulations in accordance with current� Biosafety in Microbiological and Biomedical Laboratories (BMBL), guidelines available at: https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf, and where applicable, compliant with the Select Agent Regulations through the Centers for Disease Control (CDC) and/or the United States Department of Agriculture (USDA) (42 CFR Part 73, 7 CFR Part 331, and/or 9 CFR Part 121[VM([2]�). ����� Demonstrated ability to carry out the work; ����� Adequacy of the documented experience with, and appropriateness of plans for the general technical approach to product screening, assay development, and development of improved systems for culturing difficult to grow pathogens in vitro.� Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed�five (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: Unique Entity ID 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://sam.gov/content/home. 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 Alexander Beraud, Contract Specialist, at alexander.beraud@nih.gov in MS Word or Adobe Portable Document Format (PDF). The email subject line must specify ""75N93024R00024 Small Business Sources Sought"" . Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00 PM�(EDT) on August 14, 2024. 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 at SAM.gov. 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).�
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/8104dbf45c984853b15a1450512e4ae1/view)
 
Record
SN07142222-F 20240726/240724230121 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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