Attachment IV - SF-18.pdf

PDF 89 KB Posted

Attached to
Semiautomatic Aerosol Propellant Filler
Solicitation number
75F40126Q00231
Issued by

About this file

This is a Request for Quotation (RFQ) issued by the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Testing and Research (OTR) for commercial products under FAR Part 12 and FAR Part 13 procedures. The RFQ number is 75F40126Q00231, issued on June 10, 2026. Quotations must be submitted electronically to Michele.Jackson@fda.hhs.gov no later than June 22, 2026, at 11:00 AM Eastern Time, with the subject line "[Company Name] – 75F40126Q00231/CDER-2026-133243 Quote." All questions must be submitted in writing to the same email address by June 15, 2026, at 9:00 AM Eastern Time.

The requirement is for the purchase, delivery, installation, validation support, training, and warranty of a Semiautomatic Aerosol Propellant Filler for pMDI Two-Stage Formulation to support FDA research in advanced pharmaceutical manufacturing and inhalation drug delivery systems. The RFQ specifies FOB Destination as the delivery term with multiple delivery locations. This is not a small business set-aside. Quoters must complete all attached representations and certifications. Supplies are of domestic origin unless otherwise indicated by the quoter. The government reserves the right not to contract for supplies or services based on this RFQ and does not commit to reimburse costs incurred in quote preparation.

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Other files

File Type Posted
Attachment VI - Buy American Certificate .docx DOCX document
Attachment VII - Solicitation Doument.docx DOCX document
Attachments V - Brand Name or Equal Compliance Matrix .xlsx XLSX spreadsheet
Attachments III - Past performance Reference Form .xlsx XLSX spreadsheet
Attachment II - Pricing_Schedule.xlsx XLSX spreadsheet
Attachment I - Statement of work .pdf PDF

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Text version

75F40126Q00231

1. REQUEST NO.

5a. ISSUED BY

NAME

a. NAME

c. STREET ADDRESS

d. CITY

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON

OR BEFORE CLOSE OF BUSINESS (Date)

2. DATE ISSUED 3. REQUISITION/PURCHASE REQUEST NO. 4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG.1

RATING

6. DELIVERY BY (Date)

7. DELIVERY

9. DESTINATION

a. NAME OF CONSIGNEE

b. STREET ADDRESS

PAGE OF PAGES

5b. FOR INFORMATION CALL: (No collect calls)

TELEPHONE NUMBER

AREA CODE NUMBER

8. TO:

b. COMPANY

e. STATE f. ZIP CODE

c. CITY

d. STATE e. ZIP CODE

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5a. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

THIS RFQ

REQUEST FOR QUOTATION

(THIS IS NOT AN ORDER)

IS IS NOT A SMALL BUSINESS SET ASIDEX

06/10/2026

1 15

11601 Landsdown St.

13th Floor North Bethesda MD 20852

DHHS/FDA/OAGS/DAP

Multiple

MICHELE JACKSON

06/22/2026 1100 ET

FOB DESTINATION

OTHER

(See Schedule)X

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

This is a Request for Quotation (RFQ) for commercial products prepared in accordance with FAR Part 12 and FAR Part 13 procedures utilizing the FAR Revolutionary FAR Overhaul clauses and provisions available at Acquisition.gov.

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Testing and Research (OTR), requires the purchase, delivery, installation, validation support, training, and warranty of a Semiautomatic Aerosol Propellant Filler for pMDI Two-Stage Formulation. The requirement supports FDA research in advanced pharmaceutical manufacturing and inhalation drug delivery systems.

Continued ...

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS (%) b. 20 CALENDAR DAYS (%) c. 30 CALENDAR DAYS (%) d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations

13. NAME AND ADDRESS OF QUOTER

b. STREET ADDRESS

c. COUNTY

d. CITY e. STATE f. ZIP CODE

14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

16. SIGNER

a. NAME (Type or print)

c. TITLE (Type or print)

a. NAME OF QUOTER

AREA CODE

NUMBER

15. DATE OF QUOTATION

b. TELEPHONE are are not attached

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition not usable

STANDARD FORM 18 (REV. 6-95)

Prescribed by GSA - FAR (48 CFR) 53.215-1(a)

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 15

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75F40126Q00231

Submit all questions in writing via email to

Michele.Jackson@fda.hhs.gov no later than: June

15, 2026, at 9:00 AM Eastern Time

Questions received after this date may not receive a response.

Submit quotations electronically to:

Michele.Jackson@fda.hhs.gov no later than: June

22, 2026, at 11:00 AM Eastern Time

Include in the Subject Line: [Company Name] –

75F40126Q00231/CDER-2026-133243 Quote

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

File details come from the government source that posted it. Updated .