Sources_Sought_Vendor Feedback Form_OC-2026-135574.docx
DOCX document 45 KB Posted
- Solicitation number
- OC-2026-135574
About this file
This is a Vendor Feedback Form template for the FDA Global ANDA Training Program Sources Sought Notice (SSN OC-2026-135574). The form is designed to collect market research information from potential contractors interested in providing training program services related to the Abbreviated New Drug Application (ANDA) pathway for generic drugs.
The form requests vendor company information including SAM UEI number, SAM registration expiration date, and socioeconomic status classifications (small business, SBA certifications, veteran-owned, women-owned, etc.). Vendors must identify applicable NAICS codes and confirm capability to provide all services and labor categories outlined in the draft Statement of Work. The form includes four key market research questions requiring vendors with direct experience within the past five years to provide up to three examples each: (1) demonstrated subject matter expertise in FDA generic drug regulatory requirements and experience developing regulatory training programs for government personnel; (2) established relationships with National Regulatory Authorities in low- and middle-income countries to support needs assessments, content validation, beta testing, and program dissemination; (3) current ANSI/IACET Accredited Provider status and capability to issue Continuing Education Units; and (4) experience developing and delivering SCORM-compliant e-learning programs optimized for limited technology infrastructure including low-bandwidth and offline access environments. For each example, vendors should provide contracting activity/customer name, contract number, contract type, period of performance, total contract value, and description of services. The anticipated contract period of performance is September 15, 2026 through September 14, 2031 (base year plus four option years) with the FDA Office of Acquisitions and Grants Services.
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Other files
| File | Type | Posted |
|---|---|---|
| Draft SOW_Global ANDA Training Program_OC-2026-135574.docx | DOCX document | |
| Draft Global ANDA Training_Generic Drug Curriculum_Final.docx | DOCX document |
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Text version
FDA Global ANDA Training Program
FDA-SSN: OC-2026-135574
Vendor Feedback Form
U.S. FOOD & DRUG ADMINISTRATION (FDA)
GENERIC DRUG PATHWAY CURRICULUM: FROM ANDA SUBMISSION TO GLOBAL RELIANCE
VENDOR FEEDBACK FORM
A. Vendor/Company Information Vendor/Company Name: Click or tap here to enter text.
Vendor/Company SAM UEI Number: Click or tap here to enter text.
SAM Registration Expiration Date: Click or tap here to enter text.
Socioeconomic Status for recommended NAICS code(s) below (check all that apply):
| ☐ | Small Business |
| ☐ | SBA Certified Small Disadvantaged Business |
| ☐ | SBA Certified HUBZone Firm |
| ☐ | SBA Certified 8(a) Firm |
| ☐ | Alaska Native Corporation, Indian Tribe, Native Hawaiian Organization, or Community Development Corporation |
| ☐ | Veteran-Owned Small Business |
| ☐ | Service-Disabled Veteran-Owned Small Business |
| ☐ | Women Owned Small Business (WOSB) |
| ☐ | Economically Disadvantaged Women Owned Small Business (EDWOSB) |
| ☐ | Other Than Small Business |
| ☐ | Other: Click or tap here to enter text. |
B. Which North American Industry Classification System (NAICS) code(s) would your company recommend for this requirement?
Click or tap here to enter text.
C. Is your company capable of providing all the services/task areas outlined in the draft SOW?
☐ YES ☐ NO
If No is selected, please specify which services/task areas your company is/is not able to provide.
Click or tap here to enter text.
D. Is your company capable of providing all the services/task areas outlined in the draft SOW under an existing contract vehicle that the FDA may utilize?
☐ YES ☐ NO
If Yes is selected, please specify which existing contract vehicle(s) the FDA may utilize.
Click or tap here to enter text.
If No is selected, please specify which services/task areas your company is/is not able to provide under existing contract vehicle(s) that the FDA may utilize.
Click or tap here to enter text.
E. Is your company capable of providing all the labor categories outlined in the draft SOW?
☐ YES ☐ NO
If No is selected, please specify which labor categories your company is/is not able to provide.
Click or tap here to enter text.
F. For each of the following market research questions, please provide responses only if your company has direct knowledge and experience within the last five (5) years that is pertinent to the specific question:
1. Does your company have demonstrated subject matter expertise in FDA generic drug regulatory requirements and experience developing and delivering regulatory training programs for government regulatory personnel?
☐ YES ☐ NO
If Yes is selected, please provide no more than three (3) examples using the information below (repeat as necessary):
☐ Prime Contractor ☐ Subcontractor Name of contracting activity/customer: Click or tap here to enter text.
Contract number: Click or tap here to enter text.
Contract type: Click or tap here to enter text.
Period of performance: Click or tap here to enter text.
Total contract value, inclusive of options: Click or tap here to enter text.
Description of services provided: Click or tap here to enter text.
2. Does your company have established relationships with National Regulatory Authorities (NRAs), particularly in low- and middle-income countries, that would support activities such as needs assessments, content validation, beta testing, and dissemination of a regulatory training program?
☐ YES ☐ NO
If Yes is selected, please provide no more than three (3) examples using the information below (repeat as necessary):
☐ Prime Contractor ☐ Subcontractor Name of contracting activity/customer: Click or tap here to enter text.
Contract number: Click or tap here to enter text.
Contract type: Click or tap here to enter text.
Period of performance: Click or tap here to enter text.
Total contract value, inclusive of options: Click or tap here to enter text.
Description of services provided: Click or tap here to enter text.
3. Does your company currently hold ANSI/IACET Accredited Provider status and have the capability to issue Continuing Education Units (CEUs) in accordance with the ANSI/IACET Standard?
☐ YES ☐ NO
If Yes is selected, please provide no more than three (3) examples using the information below (repeat as necessary):
☐ Prime Contractor ☐ Subcontractor Name of contracting activity/customer: Click or tap here to enter text.
Contract number: Click or tap here to enter text.
Contract type: Click or tap here to enter text.
Period of performance: Click or tap here to enter text.
Total contract value, inclusive of options: Click or tap here to enter text.
Description of services provided: Click or tap here to enter text.
4. Does your company have experience developing and delivering SCORM-compliant e-learning programs optimized for users with limited technology infrastructure, including low-bandwidth environments and offline access capability?
☐ YES ☐ NO
If Yes is selected, please provide no more than three (3) examples using the information below (repeat as necessary):
☐ Prime Contractor ☐ Subcontractor Name of contracting activity/customer: Click or tap here to enter text.
Contract number: Click or tap here to enter text.
Contract type: Click or tap here to enter text.
Period of performance: Click or tap here to enter text.
Total contract value, inclusive of options: Click or tap here to enter text.
Description of services provided: Click or tap here to enter text.
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