SSN Response Template CDER2026133243final.docx

Sources Sought Notice Response Template CDER-2026-133243 Semiautomatic Aerosol Propellant Filler for pMDI's 2-Stage Formulation

RESPONSE COVER SHEET

Company Name:

Date of Submission:

Primary Point of Contact:

Title:

Phone:

Email:

SECTION 1: COMPANY IDENTIFICATION INFORMATION

1.1 Basic Company Information

Legal Company Name:

Doing Business As (DBA):

Physical Address:

Mailing Address (if different):

Company Website:

Year Established:

Number of Employees:

1.2 Registration Information

UEI Number (formerly DUNS):

CAGE Code:

SAM.gov Expiration Date:

Tax ID Number (EIN):

SECTION 2: BUSINESS SIZE AND SOCIOECONOMIC STATUS

2.1 Business Size Classification

Is your company a small business?

☐ Yes - Small Business ☐ No - Other Than Small Business Recommended Primary NAICS Code for this requirement: __ Size Standard for this NAICS: __ Annual Revenue: $__ Number of Employees: __

2.2 Socioeconomic Certifications

Check ALL that apply to your business:

☐ Small Business (SB) ☐ HUBZone Small Business

- Certification Date: __

- Certifying Agency:

☐ Small Disadvantaged Business (SDB)

- Certification Date: __

- Certifying Agency:

☐ 8(a) Business Development Program Participant

- Certification Date: __

- Program Graduation Date:

☐ Service-Disabled Veteran-Owned Small Business (SDVOSB)

- Certification Date: __

- Certifying Agency:

☐ Veteran-Owned Small Business (VOSB)

- Certification Date: __ ☐ Woman-Owned Small Business (WOSB)

- Certification Date: __

- Certifying Agency:

☐ Economically Disadvantaged Woman-Owned Small Business (EDWOSB)

- Certification Date: __

- Certifying Agency:

☐ None of the above

SECTION 3: GSA FEDERAL SUPPLY SCHEDULE (FSS) INFORMATION

3.1 GSA Schedule Contract Status

Do you hold a current GSA Schedule contract?

☐ Yes (complete table below) ☐ No (skip to Section 4) ☐ Application in progress

3.2 GSA Schedule Contract Details

GSA Schedule Number(s):

GSA Contract Number:

Contract Award Date:

Contract Expiration Date:

Special Item Number(s) (SIN):

Schedule Name/Title:

3.3 Availability on GSA Schedule

Is the equipment/service requested in this Sources Sought available on your GSA Schedule?

☐ Yes - Fully available as specified ☐ Partially available (explain below) ☐ No - Not currently on schedule ☐ Could be added through modification If partially available or could be added, please explain:

[Text box for response]

3.4 GSA Pricing Information

Can you provide GSA pricing for this requirement?

☐ Yes ☐ No ☐ With modifications If yes, please indicate:

SECTION 4: TECHNICAL CAPABILITY

4.1 Capability Confirmation

Can your company provide the complete system as specified in the Sources Sought Notice?

☐ Yes - Can meet all requirements as specified ☐ Yes - Can exceed requirements (explain how below) ☐ Partially - Can meet some requirements (explain below) ☐ No - Cannot meet requirements Explanation (if applicable):

[Text box for response]

4.2 Specific Equipment Capabilities (Check all that apply):

Pressure Filler System:

☐ Can provide pressure filler meeting all specifications ☐ Dosing range: 0.5 - 20 ml capability ☐ Stainless steel AISI 316L product contact parts ☐ Oil-free execution ☐ Quick-changeable product aggregate Crimper System:

☐ Can provide crimper (Model 2002/100 or equivalent) ☐ Compatible with 20 mm valves ☐ Adjustable crimp height and diameter Crimp Height Measuring Gauge:

☐ Can provide digital measuring gauge with calibration certificate ☐ 0.01 mm resolution capability Propellant Pump System:

☐ Can provide propellant pump (Model 2008/100 or equivalent) ☐ 15 liter/minute capacity ☐ 2,000 kPa maximum outlet pressure ☐ Compatible with LPG, DME, HFA propellants ☐ Dual-stage filtration (5 micron and 0.1 micron) Additional Components ☐ Complete spare parts sets for all components ☐ Special tools sets ☐ Material certificates (EN 10204-3.1)

SECTION 5: DELIVERY CAPABILITY

5.1 Delivery Timeframe

Can you meet the delivery timeframe specified in the Sources Sought Notice?

☐ Yes - Can deliver within specified timeframe ☐ Yes - Can deliver earlier (specify): __ days ☐ No - Would require additional time (specify): __ days

5.2 Installation Requirements Compliance

Number of installation technicians:

5.3 Training Services:

Maximum number of trainees per session:

SECTION 6: WARRANTY/MAINTENANCE

6.1 Warranty

Can provide minimum 1-year warranty ☐ Yes ☐ No ☐ Through subcontractor/partner

SECTION 7: WARRANTY AND SERVICE CAPABILITY

7.1 Warranty Coverage

Can you provide warranty coverage as specified?

☐ Yes - Meets minimum requirements ☐ Yes - Exceeds minimum requirements ☐ No

Contractor Response

7.2 Items Covered Under Warranty

Check all items covered:

☐ Base equipment/instrument ☐ All components and parts ☐ Software/firmware updates ☐ Accessories ☐ Shipping costs for parts ☐ Preventive maintenance ☐ Emergency repairs ☐ Consumables (specify): __

SECTION 8: PRICING INFORMATION

Note: Pricing information is for market research.

8.1 Estimated Pricing

TOTAL:

8.2 Pricing Basis

Pricing is based on:

☐ GSA Schedule pricing ☐ Commercial pricing ☐ Estimated/budgetary pricing ☐ Other: __ Pricing valid through: __

SECTION 9: SUBCONTRACTING AND TEAMING

9.1 Subcontracting Plan

Do you anticipate using subcontractors for this requirement?

☐ Yes ☐ No ☐ Undetermined at this time If yes, please provide details:

9.2 Teaming Arrangements

Are you responding as part of a team?

☐ Yes ☐ No If yes, please identify team members and roles:

SECTION 10: ADDITIONAL CAPABILITIES AND INFORMATION

10.1 Value-Added Services

Check any additional services your company can provide:

☐ Extended warranty options ☐ Preventive maintenance programs ☐ 24/7 technical support ☐ Remote diagnostics ☐ Software updates/upgrades ☐ Advanced training programs ☐ Customization services ☐ Spare parts kits ☐ Loaner equipment during repairs ☐ Other: __

10.2 Additional Information

Please provide any additional information that demonstrates your company's capability to perform this requirement:

[Text box for response]

SECTION 11: ATTACHMENTS CHECKLIST

Please check all documents attached to this response:

☐ Company brochure/capability statement ☐ Product literature/specifications ☐ Technical data sheets ☐ Manufacturer authorization letter ☐ Small business certifications ☐ GSA Schedule contract copy ☐ Other: __

SECTION 12: SUBMISSION INSTRUCTIONS

Submit this form to Michele Jackson at Michele.Jackson@fda.hhs.gov on or before April 14, 2026 @10:00am. Include in the subject line of the email: Sources Sought Response – XXXXX (compqny name) Aerosol Propellant Filler System

SECTION 13: CERTIFICATIONS AND SIGNATURE

13.1 Understanding of Notice

I understand that (please check all):

☐ This is a Sources Sought Notice only and not a solicitation ☐ This response does not constitute an offer ☐ The Government has no obligation to issue a solicitation ☐ The Government will not pay for costs associated with this response ☐ All information submitted becomes Government property ☐ The Government may use this information for acquisition planning purposes

13.2 Accuracy Certification

I certify that the information provided in this Sources Sought response is accurate and complete to the best of my knowledge.

Printed Name: __ Title: __ Signature: __ Date: __ 2 | Page