About this file

This is a Standard Form 1449 solicitation for quality system regulation training services. The solicitation requests a contractor provide one session of quality system regulation and ISO 13485 training for up to 50 learners over four days in a virtual and/or in-person format between September 30, 2023 and September 29, 2024. Offerors must respond by August 25, 2023. The soliciting agency is the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services. The solicitation number is 75F40123R00056.

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31b. NAME OF CONTRACTING OFFICER (Type or print)

MADELINE R. BRYANT

Madeline Bryant -S

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

1. REQUISITION NUMBER

1262818

PAGE OF

1 29

2. CONTRACT NO. 3. AWARD/

EFFECTIVE DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER

75F40123R00056

6. SOLICITATION

ISSUE DATE

08/21/2023

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

Pamela Lee

b. TELEPHONE NUMBER (No collect calls) 8. OFFER DUE DATE/LOCAL TIME

08/25/2023 1700 ET

9. ISSUED BY CODE DAP 10. THIS ACQUISITION IS X UNRESTRICTED OR

SET ASIDE:

% FOR:

DHHS/FDA/OAGS/DAP

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

ATTN: Pamela Lee 4041 Powder Mill Road Beltsville MD 20705

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:923110

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

13b. RATING

14. METHOD OF SOLICITATION

SEE SCHEDULE DPAS (15 CFR 700)

X RFQ IFB RFP

15. DELIVER TO CODE WO71 16. ADMINISTERED BY CODE DAP

WHITE OAK CAMPUS, BUILDING 71

The US Food and Drug Administration 10903 New Hampshire Avenue Building 71 Silver Spring MD 20993

DHHS/FDA/OAGS/DAP

ATTN: Pamela Lee 4041 Powder Mill Road Beltsville MD 20705

17a. CONTRACTOR/

OFFEROR

CODE FACILITY

CODE

18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO.

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

IS CHECKED SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

Quality Systems Training

Quality System Regulation Training

Delivery: 09/29/2024 Period of Performance: 09/30/2023 to 09/29/2024

Training Continued ...

EA

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

X 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

X ARE

ARE

ARE NOT ATTACHED.

ARE NOT ATTACHED.

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

29. AWARD OF CONTRACT:

DATED

OFFER

. YOUR OFFER ON SOLICITATION (BLOCK 5),

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

30a. SIGNATURE OF OFFEROR/CONTRACTOR

30b. NAME AND TITLE OF SIGNER (Type or print)

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

HEREIN, IS ACCEPTED AS TO ITEMS:

31a. UNITED STATES OF AMERICA (SIGNATURE OF CO NT RADCTiIgNGi tOaFl lFyICsEiRg) ned by Madeline Bryant -S Date: 2023.08.14 14:08:49 -04'00'

31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

30c. DATE SIGNED

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

(Option Line Item)

09/29/2024

32a. QUANTITY IN COLUMN 21 HAS BEEN

STANDARD FORM 1449 (REV. 2/2012) BACK

75F40123R00056
DHHS/FDA/OAGS/DAP
WO71
WHITE OAK CAMPUS, BUILDING 71
DHHS/FDA/OAGS/DAP
X 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA 27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA
32a. QUANTITY IN COLUMN 21 HAS BEEN

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