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This Solicitation opportunity from Department Of Health And Human Services was posted on September 27, 2024. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

A--Request for Proposals - Phase I Clinical Trials

Closed
75N95024R00086Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 541715
New
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U.S. Army Contracting Command – Watervliet Arsenal (ACC-WVA) Organic Industrial Base (OIB) Modernization Commercial Solutions Opening (CSO)
Solicitation # W911PT26SC001
The U.S. Army Contracting Command – Watervliet Arsenal (ACC-WVA) has issued solicitation W911PT26SC001, a Commercial Solutions Opening (CSO) authorized under the National Defense Authorization Act for Fiscal Year 2026 and DFARS Subpart 212.70. This competitive solicitation is open until September 30, 2027, and is designed to acquire innovative commercial products, technologies, and services to modernize the Army's Organic Industrial Base. The scope focuses on integrating manufacturing resources, linking legacy analogue systems with digital systems, and expanding modeling and simulation to enhance the delivery of materiel solutions. The CSO targets both traditional and non-traditional business entities, including small businesses and foreign-owned firms, provided they maintain an active System for Award Management (SAM) profile and a Unique Entity ID. The acquisition process follows a multi-phased approach consisting of a written solution brief, an optional presentation or pitch, and a final Request for Commercial Solution Proposal (CSP). Evaluation is based on responsiveness, technical merit, uniqueness, and price reasonableness. Successful responses may result in fixed-price contracts awarded under FAR Part 12 Commercial Item Procedures. Current Areas of Interest (AoIs) include advanced cannon technology, electrical infrastructure improvements at Building 120, chromium facility conversion, automated manufacturing for minor components, automated cooling tower treatments, advanced CNC vertical turning lathes, and advanced tooling for radial forging. Performance is primarily located at Watervliet Arsenal and Benet Laboratories, with a general period of performance not to exceed 12 months unless otherwise specified.
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NAICS: 541715
New
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Coordinating Center for National Resource Network for the Study of Human Auditory and Vestibular Disorders (U24 Clinical Trial Not Allowed)
Solicitation # RFA-DC-28-002
Solicitation RFA-DC-28-002 is a Notice of Funding Opportunity from the National Institutes of Health, specifically the National Institute on Deafness and Other Communication Disorders, to establish a Coordinating Center for the NIDCD National Human Ear Resource Network. This collaborative network provides human inner and middle ear tissues to researchers for basic and clinical studies aimed at advancing the treatment of auditory and vestibular disorders. The Coordinating Center is responsible for maintaining network cohesiveness through the planning of workshops, symposia, and regular meetings, providing updates to laboratories, and managing communication with the public and scientific community regarding tissue donation. The maximum project period is five years, with a budget limit of 200,000 dollars in direct costs per year. Applicants, including for-profit organizations and small businesses, must maintain active registrations in SAM, eRA Commons, and Grants.gov. Proposals are evaluated based on the significance of the proposed center and the qualifications of the investigators, with additional reviews for human subject protections, inclusion policies, and the use of vertebrate animals. Key requirements include a structured Data Management and Sharing Plan and adherence to cybersecurity guidelines, including a 48-hour incident reporting window. The application process is entirely electronic and requires several standard PHS and SF424 forms, with a response deadline of March 5, 2027.
National Institutes Of Health

POSTED

1 day ago

DEADLINE

in 4 months
NAICS: 541715
New
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National Resource Network for the Study of Human Auditory and Vestibular Disorders (U24 Clinical Trial Not Allowed)
Solicitation # RFA-DC-28-001
Solicitation RFA-DC-28-001 is a Notice of Funding Opportunity issued by the National Institutes of Health under the Department of Health and Human Services to support the NIDCD National Human Ear Resource Network. The objective is to maintain a collaborative network of laboratories that serve as a national technological resource, providing human inner and middle ear tissues to researchers for basic and clinical studies to advance the treatment of auditory and vestibular disorders. The scope of work includes processing human temporal bones from the National Hearing and Balance Organ Donor Program, uploading images and medical data to EarBase, sharing gene-expression data via the gEAR repository, and providing technical instruction to increase the number of skilled researchers in the field. The NIDCD intends to commit 3.6 million dollars in FY 2028 to fund up to six awards, with a maximum project period of five years. Individual awards are limited to 450,000 dollars in direct costs per year, with an additional 150,000 dollars available for specific subawards. Applications are due on March 05, 2027, and November 01, 2027, with staggered start dates ranging from July 2027 to July 2028. Evaluation is based on the experience of the investigators, the adequacy of the institutional environment, and the protection of human subjects. Applicants must maintain active SAM registration and a Unique Entity Identifier, and they must provide a Data Management and Sharing Plan and a Material Transfer Agreement. Compliance with the Cybersecurity Act of 2015 is required, including the development of an incident response plan and notification of cybersecurity incidents within 48 hours of discovery.
National Institutes Of Health

POSTED

1 day ago

DEADLINE

in about 1 year

AI Contract Overview

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The contract pertains to a Request for Proposals issued by the National Institutes of Health (NIH), specifically under the Department of Health and Human Services, for conducting Phase I clinical trials focused on the development of small molecule and biologic therapeutics. The solicitation, identified by number 75N95024R00086, was posted on September 27, 2024, with a response deadline extended to October 11, 2024, at 5 pm ET. The contract emphasizes the need for vendors to support early-stage clinical testing, likely involving specialized services aligned with NAICS code 541715, which pertains to research and development in the physical, engineering, and life sciences. The solicitation has undergone multiple amendments to clarify and update the requirements. Amendment 0002 responded to vendor questions, revised key sections of the RFP and related attachments, and extended the submission deadline. Amendment 0003 further addresses additional vendor inquiries, ensuring clarity and transparency in the procurement process. The contract is managed through a point of contact, Evan C. Feely, whose contact details are provided for further inquiries. The procurement process is accessible via the provided link on SAM.gov, facilitating vendor engagement and submission of proposals for this critical clinical research initiative.

General Info

Phase I clinical trials for small molecule and biologics therapeutics, RFP, NIH, deadline 10/11/2024.

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

MD

Set-Aside

NONE

Documents

30

75N95024R00086 Amendment 0001

PDF, High priority: read this firstamendment
High

75N95024R00086 Amendment 0002

PDF, High priority: read this firstamendment
High

75N95024R00086 Amendment 0002

PDF, High priority: read this firstamendment
High

75N95024R00086 Amendment 0003

PDF, High priority: read this firstamendment
High

75N95024R00086 Amendment 0003

PDF, High priority: read this firstamendment
High

75N95024R00086 - Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics

PDF, High priority: read this firstrfp
High

A11 - Additional Technical Proposal Instructions

PDF, High priority: read this firstsow
High

A12 Summary of Related Activities

PDF, High priority: read this firstsupporting-documents
High

A18 Determination of Exceptional Circumstances Acknowledgment Form

PDF, High priority: read this firstspecial-notice
High

A24 Public Health Surveillance Exclusion Request Guidance

PDF, High priority: read this firstspecifications
High

Attachment 1 - Packaging and Delivery of Proposals (NIH eCPS)

PDF, High priority: read this firstspecifications
High

IDIQ Contract Statement of Work - Phase I Clinical Trials

PDF, High priority: read this firstsow
High

NIDA Supplemental Billing Instructions (Exhibit A to NIH(RC)-1)

PDF, High priority: read this firstspecifications
High

RFP 75N95024R00086 - Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics

PDF, High priority: read this firstrfp
High

Sample Task Order #1 - SOW: Project Management Plan and Kick-Off Meeting

PDF, High priority: read this firstsow
High

Sample Task Order #2 - SAD Study SOW

PDF, High priority: read this firstsow
High

Sample Task Order #3 - SAD/MAD Study SOW

PDF, High priority: read this firstsow
High

Section K - Representations, Certifications, and Other Statements of Offerors

DOCX, High priority: read this firstrepresentations-certifications
High

Technical Proposal Cost Summary of Labor and Direct Costs

PDF, High priority: read this firstspecifications
High

Wage Determination No. 2015-4269 (Revision 26)

PDF, High priority: read this firstwage-determination
High

A22 - PHS Human Subjects and Clinical Trials Information Form-H

PDF, Low priorityother
Low

A5 - Offeror's Points of Contact

PDF, Low priorityother
Low

HHS Industry User Guide for Subcontracting Plan Reviews

PDF, Low priorityother
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NIH-2043 Proposal Summary and Data Record

PDF, Low priorityother
Low

NIH(RC)-1 Invoice/Financing Request Instructions

PDF, Low prioritysupporting-documents
Low

NIH(RC)-2 Fixed-Price Invoice Instructions

PDF, Low priorityother
Low

OMB Form SF-LLL - Disclosure of Lobbying Activities

PDF, Low priorityother
Low

Protection of Human Subjects Assurance Identification/IRB Certification Form

PDF, Low priorityother
Low

RFP 75N95024R00086 Proposal Intent Response Form

PDF, Low priorityother
Low

A14_-_Breakdown_of_Proposed_Estimated_Costs.xlsx

XLSX

AI Contract Breakdown

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Timeline

7 updates
PhaseClosed
Posted

Presolicitation

Deadline changed

Response deadline changed from Jul 31, 2024 to Aug 7, 2024.

Deadline changed

Response deadline changed from Aug 7, 2024 to Aug 14, 2024.

Notice updated

Response deadline changed from Aug 14, 2024 to Aug 16, 2024. The notice description changed.

Notice updated

Response deadline changed from Aug 16, 2024 to Aug 19, 2024. The notice description changed.

Type Changed

Presolicitation → Solicitation

Notice updated

The notice title changed.

Notice updated

Response deadline changed from Oct 3, 2024 to Oct 11, 2024. The notice description changed.

Notice updated

The notice description changed.

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Nida
Contacts1 person available
OfficeBethesda, MD, 20892, USA
Office AddressBethesda, MD, 20892, USA

Full Description

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Amendment 0003: The attached amendment provides responses to additional vendor-submitted questions. Amendment 0002: The attached amendment provides responses to vendor-submitted questions; revises the RFP document and RFP Attachments 9 and 10 (Sample Task Order #2 and #3 SOWs); and extends the response deadline to 10/11/2024 at 5 pm ET. Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics

More opportunities from Department Of Health And Human Services → National Institutes Of Health Nida

Same awarding agency

NAICS: 541690
Federal
Modification to Extend Services for Scientific, Operations and Administrative Resources (SOAR) Contract Program
Solicitation # OLAO-SSD-SOAR-NOI
The National Institutes of Health (NIH) intends to negotiate and award non-competitive modifications to extend the Scientific, Operations and Administrative Resources (SOAR) contract program. This program consists of five indefinite-delivery, indefinite-quantity (IDIQ) contracts held by Axle Informatics LLC, Gap Solutions Inc., Kelly Services Inc., Guidehouse Digital LLC, and 22nd Century Technologies Inc. The primary objective is to ensure continuity of specialized scientific professional services across 29 NIH organizations, including the Office of the Director, 27 Institutes and Centers, and ARPA-H, while the agency finalizes a strategic procurement consolidation effort and a competitive follow-on acquisition. The proposed extension includes a basic ordering period from June 22, 2026, to June 21, 2027, with two optional six-month extensions extending through June 21, 2028. Additionally, the government seeks to revise FAR 52.216-22 to allow task orders to extend up to 36 months beyond the parent contract end date. While the combined maximum contract ordering value remains unchanged at $3,600,713,546, the estimated total dollar value for orders through the end of the extension is $2,174,615,674. The government projects the award of these modifications in April 2026. The SOAR program provides critical scientific staffing, such as bioinformatics scientists and molecular biologists, to support biomedical research and public health missions. The NIH has cited a critical need for these specific contract holders to avoid disruptions to ongoing research and patient diagnostics. Interested parties may submit capability statements and pricing information by March 5, 2027, although the government currently intends to proceed on a non-competitive basis with the existing holders.
Other Scientific and Technical Consulting Services

POSTED

8 months ago

DEADLINE

in 5 months
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