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This Government Contract opportunity from Department Of Health And Human Services was posted on June 27, 2022. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Drug Development Support for the Cancer Therapy Evaluation Program

Awarded
75N91021R00043Federal

Contract Overview

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

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NAICS: 541715
New
Federal
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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about 17 hours ago

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in 11 months
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 5 months
NAICS: 541715
New
Grant
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 National Cancer Institute's Cancer Therapy Evaluation Program (CTEP), under the Division of Cancer Treatment and Diagnosis, is seeking a contractor to provide comprehensive drug development support to fulfill its role as a clinical trial sponsor. This effort supports an extensive extramural clinical oncology program involving approximately 195 active Investigational New Drug Applications and 400 clinical studies, ranging from pilot to licensing trials. The scope of work requires expertise in investigational drugs, biologics, and assays to navigate regulations across various FDA offices, including CDER, CBER, and CDRH. The selected contractor will be responsible for the preparation, tracking, submission, and distribution of FDA submissions, including the operation of eCTD software. Key duties include monitoring and supporting adverse event reporting through helpdesk services, tracking investigational anti-cancer agents, and providing general administrative and technical support for regulatory activities. Additionally, the contractor must implement a Quality Control Program to ensure compliance with evolving health agency regulations and NIH and HHS policies. This requirement follows previous services performed by Technical Resources International, Inc. under NAICS code 541715.

General Info

Contract Value

$39,320,905

NAICS

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

Place of Performance

Rockville, MD, 20850, USA

Set-Aside

NONE

Award Issued Date

Documents

1

75N91021R00043 - Drug Development Support for CTEP

PDF, Low prioritypresolicitation
Low

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Timeline

2 updates
PhaseAwarded
Posted

Presolicitation

Type Changed

Presolicitation → Solicitation

Notice updated

The notice description changed.

Notice updated

Response deadline changed from Nov 16, 2021 to Nov 30, 2021. The notice description changed.

Awarded

Contract was awarded

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → NIH Nci
Contacts2 people available
OfficeBethesda, MD, 20892, USA
Office AddressBethesda, MD, 20892, USA
Contacts
DeChanta Vaughan Contract Specialist

Full Description

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THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. This synopsis follows a Sources Sought Notice that was posted on May 11, 2021 as HHS-NIH-NCI-SBSS-ETSB-00043-16 with responses due on May 26, 2021. Title: Drug Development Support for the Cancer Therapy Evaluation Program (CTEP) Background: The mission of the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is to improve the lives of cancer patients by finding better ways to treat, control and cure cancer. The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is responsible for the administration and coordination of an extensive extramural clinical oncology drug development program. CTEP, DCTD currently sponsors 195 active Investigational New Drug Applications (INDs) with the Food and Drug Administration (FDA). The sources of investigational agents are typically internally developed NCI agents and those co-developed with pharmaceutical industry collaborators. There are currently approximately four hundred (400) clinical studies conducted under these INDs that run the gamut from pilot studies through licensing studies. In addition to single-agent trials, CTEP sponsors multi-agent trials, with either combinations of investigational drugs or biomarker-driven strata of unique agents, special protocol assessments, master protocols and precision medicine studies. CTEP studies span the purview across FDA Offices including the Office of Oncologic Diseases (CDER), Division of Cellular and Gene Therapy (CBER), and Office of In Vitro Diagnostics and Radiological Health (CDRH), requiring expertise in investigational drugs, biologics and assays. The Government is seeking a Contractor to provide support for the evolving health agency regulations, NCI, NIH, and HHS policies to fulfill the role of clinical trial sponsor. The Drug Development Support for the Cancer Therapy Evaluation Program (CTEP) contract is responsible for: Providing support for the preparation, tracking, submission and distribution of FDA submissions and CTEP drug development related activities. Monitoring and Supporting Adverse Event Reporting. Tracking information regarding investigational anti-cancer agents. Providing technical and general administrative support for investigational agent development and regulatory activities. Providing a Quality Control Program. In 2002, the Drug Development Support for the Cancer Therapy Evaluation Program contract was awarded to Technical Resources International, Inc. The services are currently being performed by Technical Resources International, Inc. under the contract number HHSN261201500006C titled - Drug Development Support for the Cancer Therapy Evaluation Program. Please see the attached for further details.

More opportunities from Department Of Health And Human Services → NIH Nci

Same awarding agency

NAICS: 622110
Federal
NCI 2026 Cervical Cancer Screening Follow-Up
Solicitation # NCI-SBSS-DCEG-TDRP-0001
The National Cancer Institute (NCI) has issued a Small Business Sources Sought notice, NCI-SBSS-DCEG-TDRP-0001, to identify qualified small business sources for the 2026 Cervical Cancer Screening Follow-Up project. The primary objective is to obtain de-identified clinical and risk factor history and follow-up data for women previously enrolled in cervical cancer screening studies at Kaiser Permanente Northern California. This data, which includes HPV and cytology-based testing, colposcopy, biopsy, and treatment procedures, will be used to generate long-term risk estimates. The acquisition falls under NAICS code 622110 for General Medical and Surgical Hospitals, with a size standard of 47 million dollars. The anticipated period of performance is five years, spanning from January 25, 2027, to January 24, 2032, consisting of a 12-month base year and four 12-month option years. The selected contractor will be required to deliver five annual data sets in .txt, SAS, or EXCEL formats via NCI-approved secure encrypted methods, ensuring compliance with Section 508 ICT accessibility requirements. Additionally, the contractor must participate in quarterly WebEx meetings to review progress. Interested small businesses, including HUBZone, veteran-owned, 8(a), and woman-owned concerns, must submit a tailored capability statement of no more than five pages to the designated contracting officers by 8:00 AM Eastern Time on October 26, 2026.
General Medical and Surgical Hospitals

POSTED

13 days ago

DEADLINE

in 5 days
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