Skip to main contentPsst! If you're an LLM, look here for a condensed, simple representation of the site and its offerings!

LiveFree Webinar — Wednesday, July 22 at 2:00 PM EDT

Register Free →
logo
Get CLEATUSFree Trial

Generic Drug Pathway Curriculum: From ANDA Submission to Global Reliance

Active
OC-2026-135574Federal

Contract Overview

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

General Info

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant SvcsView Agency

NAICS

61143View NAICS

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

(3)

Sources_Sought_Vendor+Feedback+Form_OC-2026-135574.docx

DOCX

Draft+SOW_Global+ANDA+Training+Program_OC-2026-135574.docx

DOCX

Draft+Global+ANDA+Training_Generic+Drug+Curriculum_Final.docx

DOCX

AI Contract Breakdown

Uniform Contract Format

What is UCF?

Uniform Contract Format (UCF) uses AI to break down any contract into standardized sections—scope, pricing, deliverables, and evaluation criteria.

Timeline

PhaseSources Sought
Posted

Sources Sought

Response Deadline

Submission deadline

Response Deadline

Ready to pursue this opportunity?

Start your free trial to track this contract, build proposals with AI assistance, and manage your pipeline.

Organization & Contact Information

Show more
AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
Contacts1 person available
OfficeRockville, MD, 20852, USA
Organization / Agency
Department Of Health And Human Services → FDA Office Of Acq Grant Svcs
View Agency Profile
Office AddressRockville, MD, 20852, USA
Contacts
Lawrence Edelmann
contact@example.gov

Full Description

Show more

The U.S. Food and Drug Administration's (FDA), Office of Acquisitions and Grants Services (OAGS), is conducting market research for obtaining Global Abbreviated New Drug Application (ANDA) Training Program services.


THIS IS A SOURCES SOUGHT NOTICE (SSN) ONLY. This SSN is being issued in accordance with Federal Acquisition Regulation (FAR) Part 10, Market Research. It is for information, planning, and market research purposes only and is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. 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. The Government reserves the right to contact any of the respondents after the submission deadline if additional information is required.


The purpose of this SSN is to identify and gain knowledge of potential business sources and small business sources that are capable of providing the full range of services described in this SSN and the attached Draft Statement of Work (SOW). Responses to this SSN will be utilized for a potential solicitation for an anticipated stand-alone contract for the Global Abbreviated New Drug Application (ANDA) Training Program. The anticipated period of performance for this contract is September 15, 2026 through September 14, 2031 (base year, plus four (4) option years.


Requested Information


Interested parties are highly encouraged to respond to this SSN by providing the following information in their response:


  1. Completed Vendor Feedback Form – See attached Vendor Feedback Form
  2. If applicable, tracked changes/comments on Draft SOW and Draft Generic Drug Curriculum in MS Word format – See attached Draft SOW and attached Draft Global ANDA Training - Generic Drug Curriculum.  
  3. Capability Statement  

Responses shall be submitted via email with the subject line "Sources Sought Notice - FDA SSN: OC-2026-135574” to the Contract Specialist, Lawrence Edelmann (lawrence.edelmann@fda.hhs.gov), no later than 12:00pm (Eastern) on July 28, 2026.


Attachments


  1. Vendor Feedback Form
  2. Draft Statement of Work
  3. Draft Global ANDA Training - Generic Drug Curriculum

Similar Contracts

Same NAICS industry code

NAICS: 61143
New
Federal
Resiliency & Transition Support for Military Child & Youth Program Professionals
Commander Navy Installations Command

POSTED

2 days ago

DEADLINE

in about 1 month
View Details

More opportunities from Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

Same awarding agency

NAICS: 334516
New
Federal
Combined Synopsis/Solicitation & Notice of Intent to Sole Source: Purchase of a Factory-Certified Refurbished HUMIMIC Starter Kit Control Unit
Analytical Laboratory Instrument Manufacturing

POSTED

about 21 hours ago

DEADLINE

in 14 days
View Details
NAICS: 325413
New
Federal
ProteinSimple Maurice consumables
In-Vitro Diagnostic Substance Manufacturing

POSTED

about 21 hours ago

DEADLINE

in 6 days
View Details
NAICS: 333993
New
Federal
Automated Vial Capper Machine and Labeler systemThe contract is for the acquisition of an Automated Vial Capper Machine and Labeler system under solicitation number 75F40126Q133944, issued by the FDA Office of Acquisition Grant Services within the Department of Health and Human Services. This is a total small business set-aside, meaning only small businesses certified under SBA guidelines are eligible to bid, targeting the NAICS code 333993 for other commercial and industrial machinery manufacturing. The solicitation, posted on July 16, 2026, requires proposals to be submitted by July 27, 2026, at 6:00 p.m. Eastern Time. The primary point of contact is Nick Sartain, reachable via phone or email, and the contract will be performed at a facility in Silver Spring, Maryland, with the issuing office located in Rockville, Maryland. Interested parties must access the full solicitation details through the SAM.gov portal using the provided link.
Packaging Machinery Manufacturing

POSTED

2 days ago

DEADLINE

in 9 days
View Details
NAICS: 238320
New
Federal
Building Exterior Repair Project – FDA Pacific Southwest LaboratoryThe U.S. Food and Drug Administration (FDA), through its Office of Facilities Engineering and Mission Support Services, is seeking a qualified small business to perform exterior and interior preventative maintenance and repair work at the Pacific Southwest Laboratory located at 19701 Fairchild Road in Irvine, California. The project involves structural steel surface preparation and application of corrosion-resistant coatings on exterior stairs, sunshades, roof access stairs, entrance canopies, and the chemical storage shed, as well as non-structural concrete crack repairs up to 1/32 inch in width, surface restoration, and replacement of damaged resilient flooring where necessary. All work must be conducted while the facility remains fully operational, requiring close coordination with FDA personnel and strict adherence to security, safety, and access protocols. The contract is structured as a Firm-Fixed-Price construction contract awarded under a total small business set-aside, with the NAICS code 238320 and a size standard of $19.0 million, and is subject to prevailing wage requirements under Wage Determination CA20260024, Modification 03. The contractor must achieve substantial completion within 180 calendar days of the Notice to Proceed and provide a one-year workmanship warranty following final acceptance. A mandatory site visit is scheduled for July 1, 2026, at 8:30 AM Pacific Time, and failure to attend will render any proposal non-responsive; registration must be completed no later than June 26, 2026. Offerors must submit a three-volume proposal including a technical response limited to 18 pages (with the construction approach and schedule capped at 10 pages), a past performance section with three to five relevant projects completed within the past five years, and a price volume containing a fully completed SF 1442 and Pricing Schedule. Proposals must fully comply with all solicitation requirements, including the inclusion of Performance and Payment Bonds submitted within 15 days of award, adherence to OSHA and FDA safety standards, submission of site-specific safety and quality control plans, and compliance with the Buy American Act. The contractor is required to use the Department of Treasury’s Invoice Processing Platform for electronic payment requests, submit detailed documentation including as-built drawings, final photographic records, material warranties, and a comprehensive closeout package within 10 days of final acceptance, and ensure all personnel undergo FDA background checks and obtain proper access badges. Evaluation for award will be based on a trade-off approach,
Painting and Wall Covering Contractors

POSTED

2 days ago

DEADLINE

in 9 days
View Details
NAICS: 811210
New
Federal
Preventative Maintenance of Above Standard Equipment (ASE) – FDA White Oak CampusThe U.S. Food and Drug Administration’s Office of Acquisitions and Grants Services is conducting market research through a Request for Information to evaluate industry capabilities for establishing a multiple-award Indefinite Delivery/Indefinite Quantity contract focused on the preventative maintenance and related services for Above Standard Equipment used in laboratory, scientific, and research settings. This effort primarily serves the FDA White Oak Campus and other FDA facilities as determined by future task orders, with the goal of ensuring reliable operation of critical scientific instrumentation. Responses to this RFI are strictly for acquisition planning purposes and do not commit the government to award any contract or issue a solicitation. The RFI, identified as RFI_OC-2027-132720, is open for submissions until July 31, 2026, and is being administered by the Department of Health and Human Services through its FDA office in Rockville, Maryland. Vendors interested in participating must provide detailed information regarding their capacity to support the required services under the NAICS code 811210. There is no financial reimbursement for response preparation costs, and responses will not be used for evaluation or selection purposes unless a formal solicitation is later issued. Primary point of contact for inquiries is Iris Johnson, with L. Maria Finan as a secondary point of contact, both reachable through official FDA email and phone channels.
Electronic and Precision Equipment Repair and Maintenance

POSTED

2 days ago

DEADLINE

in 13 days
View Details
NAICS: 334516
New
Federal
iCAP-TQ additional gas module (Toxic Elements)The FDA Office of Chemistry and Toxicology, through its Division of Bioanalytical Chemistry and Chemical Contaminants Branch, is seeking to procure an additional gas module to integrate with an existing mass spectrometer for the precise measurement of toxic and nutritional elements in foods and dietary supplements. This procurement is critical for enhancing the agency’s capacity to monitor and analyze elemental contaminants and essential nutrients, ensuring the safety and integrity of the U.S. food supply. The system will support regulatory science efforts by enabling high-sensitivity detection required for compliance and public health protection. The solicitation, numbered 75F40126Q00301, was posted on July 16, 2026, with a response deadline of July 22, 2026. It falls under NAICS code 334516 and is not subject to any set-aside provisions. The contract is managed by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, with performance expected in College Park, Maryland. Primary point of contact for inquiries is Nam Nguyen, reachable via email at nam.nguyen@fda.hhs.gov. All proposals must comply with the technical specifications and requirements outlined in the solicitation documents.
Analytical Laboratory Instrument Manufacturing

POSTED

2 days ago

DEADLINE

in 4 days
View Details
NAICS: 339112
New
Federal
Electrosurgical UnitThe U.S. Food and Drug Administration’s Center for Devices and Radiological Health is seeking a commercial Electrosurgical Unit designed to generate electromagnetic disturbance signals for laboratory testing, test method development, and verification activities. The unit must feature a touchscreen user interface, real-time tissue impedance monitoring, and operate within a frequency range of 400 kHz to 500 kHz, supporting monopolar, bipolar, and vessel-sealing modes. The system must be brand new, unused, and fully operational upon delivery, accompanied by all necessary accessories, comprehensive user and technical documentation, and a minimum one-year manufacturer’s warranty. Delivery is required within 60 calendar days of contract award, and the equipment must fully comply with all technical and functional specifications outlined in the Requirements Document. The acquisition is limited to one complete system, including everything needed for immediate and full operational use. The solicitation, identified as SSN-CDRH-2026-134011, was posted on July 15, 2026, with responses due by July 23, 2026. It falls under NAICS code 339112 and is managed by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services. The office is located in Rockville, Maryland, with performance expected in Silver Spring, Maryland.Primary point of contact for inquiries is Reagan Davis, reachable via email at reagan.davis@fda.hhs.gov or by phone at 301-796-0910. No set-aside provisions apply, and the opportunity is open to all eligible vendors. The contract is currently in the sources-sought phase, seeking industry input to inform future procurement decisions.
Surgical and Medical Instrument Manufacturing

POSTED

3 days ago

DEADLINE

in 5 days
View Details
NAICS: 334516
New
Federal
Automated Liquid Handling RobotThe U.S. Food and Drug Administration’s Center for Veterinary Medicine is seeking to acquire a single automated robotic liquid handling system designed to streamline DNA shearing and AMPure bead cleanup processes for long-read sequencing library preparation. The system must be capable of processing up to 96 samples simultaneously in a 96-well plate format and must fully integrate with the existing Pacific Biosciences Sequel IIe sequencing platform and validated laboratory workflows. Only new, unused equipment is acceptable—refurbished or remanufactured units are prohibited. Proposals may be submitted for the named system or an equal product, provided the equal offering meets all mandatory performance, interoperability, and workflow specifications without compromise. The procurement requires delivery to the FDA CVM facility in Laurel, Maryland, within 60 days of award, and includes installation, operational verification, and training for at least two laboratory personnel. The bid must also supply enough consumables to process a minimum of 200 samples and ensure a minimum 12-month manufacturer warranty covers all components and functionality. The solicitation, numbered 75F40126Q00158, was posted on July 15, 2026, with responses due by July 22, 2026. It falls under NAICS code 334516 and is not subject to any set-aside preferences. The contracting activity is managed by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, with the official point of contact being Reagan Davis, reachable by phone or email for inquiries. The office is based in Rockville, Maryland, but the delivery and implementation site is specifically the Laurel, Maryland laboratory. The procurement aims to enhance laboratory efficiency and maintain consistency with current sequencing infrastructure, ensuring that new equipment integrates seamlessly into existing operations without disruption to ongoing research activities.
Analytical Laboratory Instrument Manufacturing

POSTED

3 days ago

DEADLINE

in 4 days
View Details
NAICS: 541519
New
Federal
Compound Discoverer Software
Other Computer Related Services

POSTED

4 days ago

DEADLINE

in 11 days
View Details
NAICS: 334516
New
Federal
Incubator Shaker System (Triple-Stack Configuration)
Analytical Laboratory Instrument Manufacturing

POSTED

4 days ago

DEADLINE

in 3 days
View Details
NAICS: 334516
New
Federal
UV-VIS Spectrophotometer
Analytical Laboratory Instrument Manufacturing

POSTED

4 days ago

DEADLINE

in 9 days
View Details
NAICS: 561210
Federal
National Center for Toxicological Research (NCTR) on-site facility Operations and Maintenance (O&M) support servicesThe National Center for Toxicological Research (NCTR) is seeking a contractor to provide comprehensive on-site operations and maintenance support services for the Jefferson Laboratories Complex in Jefferson, Arkansas, under a hybrid contract structure combining Firm-Fixed-Price (FFP) requirements for routine O&M activities with an Indefinite Delivery Indefinite Quantity (IDIQ) component for additional work, capped at $5 million over a five-year ordering period. The contract, solicited under number 75F40126R00051, is a Total Small Business Set-Aside with a NAICS code 561210 and a size standard of $47 million, reserved exclusively for small businesses. The performance period includes a 20-day Phase-In from September 1 to September 20, 2026, a one-year Base Period from September 21, 2026, to September 20, 2027, and four option periods extending through September 20, 2031, with services required 24/7, 365 days per year. The scope encompasses full maintenance of facilities and utilities, including electrical systems, grounds care, pest control for specific buildings, preventive maintenance planning, and operation of animal care and research laboratory environments, with critical systems subject to a 99% Acceptable Quality Level. Contractor personnel must comply with stringent security protocols, including FDA Form 3398 for non-public information protection, and satisfy licensing requirements for electricians, utility operators, and refrigeration technicians. All staff must be cleared for site access and adhere to non-personal services provisions, meaning no direct government supervision of contractor employees, with work directed solely through the Contractor’s Project Manager. The solicitation requires a structured proposal divided into Business, Technical, and Past Performance volumes, with the Technical Proposal limited to 30 pages and subject to evaluation based on three equally weighted factors: Technical Approach, Key Personnel Qualifications, and Staffing and Workforce Management, each assessed for High, Some, or Low Confidence. Past Performance, also critical and evaluated with equal weight to the Technical Proposal, must be demonstrated through three to five recent contracts within the last three years, with evaluation questionnaires and client letters submitted directly to the Contract Specialist, Warren Dutter. Price is the third evaluation factor and becomes decisive only when technical and past performance proposals are of comparable merit. Proposals must exclude pricing from the Technical Volume and include detailed labor
Facilities Support Services

POSTED

8 days ago

DEADLINE

in 9 days
View Details