Inactive

Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to ... Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Enteric and Sexually Transmitted Infections Branch (ESTIB) has a requirement for the design and performance of a longitudinal, multisite clinical study that will enroll untreated patients who have primary, secondary or early latent syphilis. Description Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS) strives to understand, treat and ultimately prevent the myriad of infectious and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which are funded through a variety of research grants and contracts. The NIAID Enteric and Sexually Transmitted Infections Branch supports research in bacterial enteric pathogens and sexually transmitted infections (STIs). Syphilis is an STI caused by the bacterial pathogen Treponema pallidum. The number of syphilis cases, especially congenital syphilis, has significantly increased nationally in the last five years. The CDC reported over 100,000 cases of syphilis in the U.S. in 2018, which is a 14% increase from 2017, and that year there was also a 40% rise in cases of congenital syphilis. Therefore, urgent efforts are needed to design and implement control and preventive measures for syphilis. Suboptimal syphilis diagnostics and insufficient information on the human immune response to T. pallidum infection pose a critical barrier to syphilis efforts. Most cases of syphilis are diagnosed by using a screening algorithm involving multiple serum antibody tests, all with imperfect specificity and sensitivity. Although these tests have been used in some fashion since the 1930s, they have well-known limitations including the inability to reliably distinguish between current and past infections, and difficulty in determining cure after antibiotic administration. In the past few decades, modern molecular techniques such as nucleic acid amplification systems and platforms, transcriptomics, proteomics and metabolomics have been developed and successfully applied to diagnosis of infectious diseases. However, developers of potential syphilis diagnostics have little to no access to high-quality syphilis patient specimens for advancing product development. This RFP is intended to fill this gap and facilitate efforts towards syphilis control, prevention and ultimately elimination. The 16-month contract Base will include protocol development, activation of multiple clinical sites, protocol implementation and the collection and delivery of specimens from a minimum of 50 patients with confirmed syphilis, or possibly have serofast status, who complete the protocol. Three 10-month Options will be for the collection of specimens from a minimum of 75 syphilis patients per option. The number and identity of participating clinical sites shall be determined by the contractor. The contractor also shall institute a panel of syphilis experts that will evaluate each patient’s clinical data and adjudicate the final diagnosis and stage of disease (primary, secondary or early latent syphilis, along with a subset of serofast patients if proposed). The contractor shall send specimens to an NIAID-supported repository from patients who have completed the study along with all metadata that includes, but is not limited to, the adjudication of the expert panel and results from all syphilis-related and other pertinent diagnostic/medical tests.

Inactive

Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to ... Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Enteric and Sexually Transmitted Infections Branch (ESTIB) has a requirement for the design and performance of a longitudinal, multisite clinical study that will enroll untreated patients who have primary, secondary or early latent syphilis. Description Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS) strives to understand, treat and ultimately prevent the myriad of infectious and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which are funded through a variety of research grants and contracts. The NIAID Enteric and Sexually Transmitted Infections Branch supports research in bacterial enteric pathogens and sexually transmitted infections (STIs). Syphilis is an STI caused by the bacterial pathogen Treponema pallidum. The number of syphilis cases, especially congenital syphilis, has significantly increased nationally in the last five years. The CDC reported over 100,000 cases of syphilis in the U.S. in 2018, which is a 14% increase from 2017, and that year there was also a 40% rise in cases of congenital syphilis. Therefore, urgent efforts are needed to design and implement control and preventive measures for syphilis. Suboptimal syphilis diagnostics and insufficient information on the human immune response to T. pallidum infection pose a critical barrier to syphilis efforts. Most cases of syphilis are diagnosed by using a screening algorithm involving multiple serum antibody tests, all with imperfect specificity and sensitivity. Although these tests have been used in some fashion since the 1930s, they have well-known limitations including the inability to reliably distinguish between current and past infections, and difficulty in determining cure after antibiotic administration. In the past few decades, modern molecular techniques such as nucleic acid amplification systems and platforms, transcriptomics, proteomics and metabolomics have been developed and successfully applied to diagnosis of infectious diseases. However, developers of potential syphilis diagnostics have little to no access to high-quality syphilis patient specimens for advancing product development. This RFP is intended to fill this gap and facilitate efforts towards syphilis control, prevention and ultimately elimination. The 16-month contract Base will include protocol development, activation of multiple clinical sites, protocol implementation and the collection and delivery of specimens from a minimum of 50 patients with confirmed syphilis, or possibly have serofast status, who complete the protocol. Three 10-month Options will be for the collection of specimens from a minimum of 75 syphilis patients per option. The number and identity of participating clinical sites shall be determined by the contractor. The contractor also shall institute a panel of syphilis experts that will evaluate each patient’s clinical data and adjudicate the final diagnosis and stage of disease (primary, secondary or early latent syphilis, along with a subset of serofast patients if proposed). The contractor shall send specimens to an NIAID-supported repository from patients who have completed the study along with all metadata that includes, but is not limited to, the adjudication of the expert panel and results from all syphilis-related and other pertinent diagnostic/medical tests. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about April 1, 2021, 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 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 Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS) strives to understand, treat and ultimately prevent the myriad of infectious and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which are funded through a variety of research grants and contracts. The NIAID Enteric and Sexually Transmitted Infections Branch supports research in bacterial enteric pathogens and sexually transmitted infections (STIs). Syphilis is an STI caused by the bacterial pathogen Treponema pallidum. The number of syphilis cases, especially congenital syphilis, has significantly increased nationally in the last five years. The CDC reported over 100,000 cases of syphilis in the U.S. in 2018, which is a 14% increase from 2017, and that year there was also a 40% rise in cases of congenital syphilis. Therefore, urgent efforts are needed to design and implement control and preventive measures for syphilis. Suboptimal syphilis diagnostics and insufficient information on the human immune response to T. pallidum infection pose a critical barrier to syphilis efforts. Most cases of syphilis are diagnosed by using a screening algorithm involving multiple serum antibody tests, all with imperfect specificity and sensitivity. Although these tests have been used in some fashion since the 1930s, they have well-known limitations including the inability to reliably distinguish between current and past infections, and difficulty in determining cure after antibiotic administration. In the past few decades, modern molecular techniques such as nucleic acid amplification systems and platforms, transcriptomics, proteomics and metabolomics have been developed and successfully applied to diagnosis of infectious diseases. However, developers of potential syphilis diagnostics have little to no access to high-quality syphilis patient specimens for advancing product development. This RFP is intended to fill this gap and facilitate efforts towards syphilis control, prevention and ultimately elimination. In order to supply developers with high-quality and varied syphilis patient specimens, this RFP will support the performance of a longitudinal clinical study that will obtain specimens from syphilis patients and abstracted clinical data. These specimens and data will be deposited by the contractor into an NIAID-supported repository. Specimens and related data will be released to developers under the discretion of NIAID in order to advance syphilis diagnostic product development. Purpose and Objectives The purpose of this requirement is to design and perform a longitudinal, multisite clinical study that will enroll untreated patients who have primary, secondary or early latent syphilis. Project requirements The 16-month contract Base will include protocol development, activation of multiple clinical sites, protocol implementation and the collection and delivery of specimens from a minimum of 50 patients with confirmed syphilis who complete the protocol. Three 10-month Options will be for the collection of specimens from a minimum of 75 syphilis patients per option. The number and identity of participating clinical sites shall be determined by the contractor. The contractor also shall institute a panel of syphilis experts that will evaluate each patient’s clinical data and adjudicate the final diagnosis and stage of disease (primary, secondary or early latent syphilis). The contractor shall send specimens to an NIAID-supported repository from patients who have completed the study along with all metadata that includes, but is not limited to, the adjudication of the expert panel and results from all syphilis-related and other pertinent diagnostic/medical tests. Anticipated period of performance It is anticipated that one (1) cost-reimbursement type contract will be awarded with a 16-month base period beginning on or around February 1, 2022. The award is anticipated to include three (3) 10-month option periods. The total contract duration, inclusive of the base and all options, shall not exceed 46 months. Other important considerations N/A 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; Demonstrated ability to carry out the work; 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: 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/SAM/pages/public/index.jsf. 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 Aytaj Vily, Contract Specialist, at aytaj.vily@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NIAID-SBSS-DMID-NIHAI75N93021R00005. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 12:00PM (Eastern Prevailing Time) on 02/19/2021. 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 beta.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).