Sol Doc.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

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

OFFEROR

DAO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Hilda Aryeh

DHHS/FDA/OAGS/DAO

CODE 16. ADMINISTERED BYCODE

X

X

541990

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAO

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

04/24/2024 1700 ET

03/27/2024

HILDA ARYEH

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40124R00056

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 64 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

Multiple Destinations

15. DELIVER TO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Hilda Aryeh

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$19.5

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

ISSUE DATE

DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DAO

WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Period of Performance: 06/10/2024 to 06/09/2027

1 Proficiency Testing program required for field labs to maintain ISO 17025 requirements

Delivery: 06/09/2025 Delivery Location Code: ATL-DO SE-RO/ SE-RL

60 EIGHTH ST NE

60 EIGHTH ST NE

Continued ...

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

HEREIN, IS ACCEPTED AS TO ITEMS:

DATED

IAN S. WEISS

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

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

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

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

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

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

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REFERENCE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

ATLANTA GA 30309 US

Period of Performance: 06/10/2024 to 06/09/2025

2 Option Year 1-Proficiency Testing program required for field labs to maintain ISO 17025 requirements

(Option Line Item)

06/10/2025

Delivery: 06/09/2026

Delivery Location Code: 34

FDA/OCI

4041 POWDER MILL ROAD

SUITE 200

CALVERTON MD 20705

Period of Performance: 06/10/2025 to 06/09/2026

3 Option Year 2-Proficiency Testing program required for field labs to maintain ISO 17025 requirements

(Option Line Item)

06/10/2026

Delivery: 06/09/2027

Delivery Location Code: 34

FDA/OCI

4041 POWDER MILL ROAD

SUITE 200

Continued ...

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

64 2 of

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 64

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

75F40124R00056

CALVERTON MD 20705

Period of Performance: 06/10/2026 to 06/09/2027

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

Sponsored by GSA

FAR (48 CFR) 53.110

FDA-24-RFQ- 75F40124R0005 Page 4 of 64

1. DESCRIPTION

Proficiency Testing (PT) programs are an external quality control to measure a laboratory’s proficiency. FDA field laboratories must maintain ISO 17025 accreditation. According to ISO 17025 requirements and AOAC guidelines, laboratories are required to participate in relevant and available proficiency testing provided by accredited proficiency testing providers administering acceptable proficiency testing programs which are conducted yearly. The Food and Drug Administration (FDA) / Office of Regional Affairs/Office of Regulatory Science (ORS)/ HFC-140 has a requirement for the purchase of ORS Food and Feed Laboratory annual Proficiency Testing for the following three programs:

1. Standard Microbiology

2. Pesticide Residue in Fruits and Vegetables

3. Nutrients in Infant Formula and Adult Nutritional’s

1.1 Notice Of Combined Synopsis/Solicitation

This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

1.2 Notice Of FAC

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-03, effective February 23, 2024.

(https://www.acquisition.gov/content/publication-fac-2024-02).

1.3 Notice Of NAICS/Set Aside

This requirement is intended for full and open competition. The associated North American Industry Classification System (NAICS) code is 541990 - Professional, Scientific, And Technical Service, ($19.5M). It is advised that SAM be active when submitting the proposal. Offerors must have an active registration in SAM.gov (https://beta.sam.gov), with completed representations and certifications, by the close date of the solicitation. Proposals submitted by offerors not registered in SAM.gov will not be considered.

2. CONTRACT TYPE AND MINUMUM/MAXIMUM AMOUNT

2.1 This is a Firm-Fixed Price Contract.

2.2 Consideration And Payment

The Contractor shall provide the necessary personnel, equipment, supplies, and support services to perform as described in Section 4 of this document. In consideration for successful performance https://www.acquisition.gov/content/publication-fac-2024-02 https://beta.sam.gov/

FDA-24-RFQ- 75F40124R0005 Page 5 of 64 of these services, the Contractor shall be paid upon the presentation of a proper invoice in accordance with the applicable invoice clause with the Firm Fixed Price contract type specified.

3. PRICING AND ORDERING OF SERVICES

3.1 Description of Supplies & Services

Pricing Schedule:

Base Period 6/10/2024 – 6/9/2025

Option Year 1 6/10/2025 – 6/9/2026

Option Year 2 6/10/2026 – 6/9/2027

ITEM NAME (Model Number if possible)

Quantity Unit Price Total Cost

0001 Proficiency Testing Sample for Microbiology (M01)

0002 Proficiency Testing Sample for Pesticides (P01)

0003 Proficiency Testing Sample for Infant Formula (IF01)

Total Price

ITEM NAME (Model Number if possible)

Quantity Unit Price Total Cost

0001 Proficiency Testing Sample for Microbiology (M01)

0002 Proficiency Testing Sample for Pesticides (P01)

0003 Proficiency Testing Sample for Infant Formula (IF01)

Total Price

ITEM NAME (Model Number if possible)

Quantity Unit Price Total Cost

0001 Proficiency Testing Sample for Microbiology (M01)

FDA-24-RFQ- 75F40124R0005 Page 6 of 64

4. DESCRIPTION/SPECIFICATIONS

4.1 Background

Proficiency Testing (PT) programs are an external quality control to measure a laboratory’s proficiency. FDA field laboratories must maintain ISO 17025 accreditation. According to ISO 17025 requirements and AOAC guidelines, laboratories are required to participate in relevant and available proficiency testing provided by accredited proficiency testing providers administering acceptable proficiency testing programs which are conducted yearly.

4.2 Objectives:

The Food and Drug Administration (FDA) / Office of Regional Affairs/Office of Regulatory Science (ORS)/ HFC-140 has a requirement for the purchase of ORS Food and Feed Laboratory annual Proficiency Testing for the following three programs:

1. Standard Microbiology

2. Pesticide Residue in Fruits and Vegetables

3. Nutrients in Infant Formula and Adult Nutritional’s

4.3 Scope

ORS requires PT services, from an ISO 17043-accredited provider whose accreditation scope includes, at a minimum: Microbiology in Foods, Pesticides in foods, and Vitamins and Nutrients in Infant Formulas. The selected provider must conduct accredited Proficiency Testing in all three programs listed in this Statement of Work (e.g. the Standard Microbiology Program, Pesticide Residue in Fruits and Vegetables, and Nutrients in Infant Formula and Adult Nutritionals) for laboratories that conduct analyses in the area of food safety as specified below:

1. Standard Microbiology Program – Proficiency Testing in this program must demonstrate proficiency in detection of pathogens (including Salmonella, E. coli O157:H7, and Listeria), as well as quantifying E. coli, Coagulase Positive Staphylococcus, yeast and mold, and aerobic organisms. The selected provider must provide test samples, qualitative and quantitative, at a frequency of four shipments per year to each lab. Evaluation of O and H antigens is to be included for Salmonella and identification of Listeria species.

0002 Proficiency Testing Sample for Pesticides (P01)

0003 Proficiency Testing Sample for Infant Formula (IF01)

Total Price

FDA-24-RFQ- 75F40124R0005 Page 7 of 64

2. Pesticide Residues in Fruits and Vegetables - Proficiency Testing in this program must identify the proficiency of laboratories that conduct analyses in the area of food safety that test for possible pesticide residues in fruit and vegetable matrix.

3. Nutrients in Infant Formula and Adult Nutritionals - Proficiency Testing in this Program must identify the proficiency of laboratories that conduct analyses in the area of food safety that test for vitamin A, vitamins B1, B2, B3, B6, B12, B5 Pantothenic Acid, vitamins D, D2, D3, vitamin E, vitamin K1, fatty acids, iodine, nucleotides (total), chromium, selenium and molybdenum (UTM) and myo-inositol.

4. PT Samples, whose expected values are to be unknown to the labs, are to be shipped to identified FDA labs by the selected provider. Labs are to analyze the PT samples and return their results electronically to the selected proficiency provider. The selected provider will collect the returned results and review them to determine whether each participating laboratory passes or fails established performance levels, A performance evaluation will then be issued to both the evaluated lab and to designated Project Officer. The cost of all shipping and handling of PT test materials is to be included as part of the total contract cost and paid by the selected service provider.

4.4 Requirements:

The selected vendor will independently and not as an agent of the Government, furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incidental to the performance of the work as described below:

A. Detailed Description The selected provider will conduct Proficiency Testing for Microbiology, Pesticides in Fruits and Vegetables, and Nutrients in Infant Formula and Adult Nutritionals as follows:

Microbiology Proficiency Testing Rounds Frequency: Four (4) rounds per year at 3 to 4 month intervals to each of the labs identified in Table 1 Microbiology below.

Tests Required:

Identification of pathogens - Salmonella, E. coli O157:H7, Listeria species Quantification –E.

coli, Coagulase Positive Staphylococcus, yeast and mold aerobic organisms.

Stereotyping – O and H antigens for Salmonella.

Matrix: mashed potato Reporting: Results reported electronically online to a secure and confidential website.

Electronic Reports must provide z-scores, statistics, and graphs used for the evaluation of results and trending of data.

Statistics: Statistical analysis on participant results must be performed in accordance with the ISO Standard 13528 and/or 2006 IUPAC Harmonized Protocol

Distribution: Proficiency testing rounds must be shipped to seven (7) different locations as follows:

FDA-24-RFQ- 75F40124R0005 Page 8 of 64

Table 1 Microbiology Program Site Location and POC Information FDA/Arkansas Laboratory 3900 NCTR Rd, Bldg 26 Jefferson, AR 72079-9502 POC to be determined at time of award

FDA/Northeast Food and Feed Laboratory 158-15 Liberty Ave Jamaica, NY 11433-1034 POC to be determined at time of award

FDA/Pacific Northwest Laboratory 2201 23rd Dr. SE Bothell, WA 98021 POC to be determined at time of award

FDA/Pacific Food and Feed Laboratory 19701 Fairchild Irvine, CA 92612 POC to be determined at time of award

Southeast Food and Feed Laboratory 60 Eighth Street NE Atlanta, GA 30309 POC to be determined at time of award

FDA/San Francisco Laboratory 1201 Harbor Bay Parkway Alameda, CA 94502 POC to be determined at time of award

FDA/Denver Laboratory 6th Ave. & Kipling Building 20 W10 Denver, CO 80225 POC to be determined at time of award

Pesticide Proficiency Testing Rounds Frequency: Two (2) rounds per year with at least 3-month intervals between rounds to each of the labs identified in Table 2 Pesticide below.

Tests Required: Three (3) major pesticide groups covered with a variety of different compounds

Carbamates Organophosphates Chlorinated Hydrocarbons

Matrix: Vegetable and/or fruit matrix Reporting: Results reported electronically online to a secure and confidential website. Electronic Reports must provide z-scores, statistics, and graphs used for the evaluation of results and trending of data.

Statistics: Statistical analysis on participant results must be performed in accordance with the ISO Standard 13528 and/or 2006 IUPAC Harmonized Protocol

Distribution: Proficiency testing rounds must be shipped to five (5) different locations as follows:

Table 2 Pesticide Program Site Location and POC Information

FDA-24-RFQ- 75F40124R0005 Page 9 of 64

FDA/Pacific Food and Feed Laboratory 19701 Fairchild Irvine, CA 92612 POC to be determined at time of award

FDA/Arkansas Laboratory 3900 NCTR Rd, Bldg 26 Jefferson, AR 72079-9502 POC to be determined at time of award

FDA/Kansas City Laboratory 10749 W. 84th Terrace Lenexa, KS 66214 POC to be determined at time of award

FDA/Pacific Northwest Laboratory 2201 23rd Dr. SE Bothell, WA 98021 POC to be determined at time of award

FDA/Northeast Food and Feed Laboratory 158-15 Liberty Ave Jamaica, NY 11433-1034 POC to be determined at time of award

Nutrients Proficiency Testing Rounds Frequency: Three (3) rounds per year with 3-4 month intervals to laboratory identified in Table3 Nutrition below.

Tests Required –This program will include vitamin A, vitamins B1, B2, B3, B6, B12, B5 Pantothenic Acid, vitamins D, D2, D3, vitamin E, vitamin K1, fatty acids, iodine, nucleotides (total), chromium, selenium and molybdenum (UTM) and myo-inositol Matrix: Infant Formula/Adult Nutritionals matrix

Reporting: Results reported electronically online to a secure and confidential website.

Electronic Reports must provide z-scores, statistics, and graphs used for evaluation of results and for trending of data Statistics: Statistical analysis on participant results must be performed in accordance with the ISO Standard 13528 and/or 2006 IUPAC Harmonized Protocol Distribution: Proficiency testing rounds must be shipped to one location as follows:

Table 3 Nutrition Program Site Location and POC Information Southeast Food and Feed Laboratory 60 Eighth Street NE Atlanta, GA 30309 POC to be determined at time of award

Reporting Requirements A. Reports

For the Standard Microbiology Program, the selected provider must provide the individual labs an electronic copy of their individual results, which is included in the participant cost of

FDA-24-RFQ- 75F40124R0005 Page 10 of 64 the program. There must also be a compiled summary report for each of the four (4) shipments per year for this program.

For the Pesticide Residue Program, the individual labs will receive an electronic copy of their individual results, this is included in the participant cost of the program. There must also be a compiled summary report for each of the two (2) shipments per year for this program.

For the Nutrients in Infant Formula and Adult Nutritionals Program, the individual lab will receive an electronic copy of its results, this is included in the participant cost of the program. There must also be a complied summary report for each of the three (3) shipments per year for this program.

B. Compiled Reports Base Year

The contractor shall provide a “Compiled Summary” for all Proficiency Testing, for each proficiency round. Each consolidated report will consist of an individual report for each of the three programs, that includes the testing results from all labs included in a specific program. Reports are to be presented to the Project Officer, (to be identified at time of award) as an electronic document within 30 business days following the end of each proficiency sample round.

FDA-24-RFQ- 75F40124R0005 Page 11 of 64Base Year - Proficiency Testing Deliverable Quantity Location Frequency per year Deliverable Time

Period Microbiology Program

1. Microbiology Proficiency Testing Sample Round to each lab

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

2. Electronic report of the lab results for each lab.

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

4 30 Days after end of PT round

Pesticide Program

1. Pesticide Proficiency Testing Sample Round to each lab

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

2. Electronic report of the lab results for each lab.

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

2 30 Days after end of PT round

Infant Formula/Adult Nutritionals Program

1. Infant Formula/Adult Nutritionals Proficiency Testing Sample Round to each lab

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

2. Electronic report of the lab results for each lab.

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

3. Electronic compiled summary Report for all

1 Project Officer

3 30 Days after end of PT round

FDA-24-RFQ- 75F40124R0005 Page 12 of 64

Each report shall include all results from ALL individual labs participating in each of the three program areas. A total of four (4) quarterly reports for the microbiological area; three

(3) reports for the nutritional area and two (2) reports for the pesticide area will be compiled in the base year.

4.5 Option Years

The contractor shall provide a “Compiled Summary” for all Proficiency Testing, for each proficiency round. Each consolidated report will consist of an individual report for each of the three programs, that includes the testing results from all labs included in a specific program. Reports are to be presented to the Project Officer (to be identified at time of award) as an electronic document within 30 business days following the end of each proficiency sample round.

Each report shall include all results from ALL individual labs participating in each of the three program areas. A total of four (4) quarterly reports for the microbiological area; three (3) reports for the nutritional area and two (2) reports for the pesticide area will be compiled in each of the option years.

5.DELIVERABLES

5.1 Deliverable(s)

Specific deliverables and a schedule of deliverables will be identified in each task order.

Delivery Instructions for Reports

Unless otherwise specified, all reports or copies of reports shall be delivered to: E-mail:(to be identified at time of award) Deliverables:

Option Year 1 - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time

Period Microbiology Program

1. Microbiology Proficiency Testing Sample Round to each lab

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a

4 3 to 4-month intervals rounds for all participating labs.

**To be identified at the time of the award of the contract

FDA-24-RFQ- 75F40124R0005 Page 13 of 64 list of participating FDA Labs

2. Electronic report of the lab results for each lab.

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

4 30 Days after end of PT round

Pesticide Program

1. Pesticide Proficiency Testing Sample Round to each lab

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

2. Electronic report of the lab results for each lab.

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

2 30 Days after end of PT round

Infant Formula/Adult Nutritionals Program

1. Infant Formula/Adult Nutritionals Proficiency Testing Sample Round to each lab participating FDA Labs

3 3-month intervals

2. Electronic report of the lab results for each lab.

3 3-month intervals

FDA-24-RFQ- 75F40124R0005 Page 14 of 64 above for a list of participating FDA Labs

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

3 30 Days after end of PT round

Option Year 2 - Proficiency Testing Deliverable Quantity Location Frequency per year Deliverable

Time Period

Microbiology Program

1. Microbiology Proficiency Testing Sample Round to each lab

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

2. Electronic report of the lab results for each lab.

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

Option Year 2 - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time

Period

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

4 30 Days after end of PT round

Pesticide Program

1. Pesticide Proficiency Testing Sample Round to each lab

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month

FDA-24-RFQ- 75F40124R0005 Page 15 of 64

2. Electronic report of the lab results for each lab.

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

2 30 Days after end of PT round

Infant Formula/Adult Nutritionals Program

1. Infant Formula/Adult Nutritionals Proficiency Testing Sample Round to each lab participating FDA Labs

3 3-month intervals

2. Electronic report of the lab results for each lab.

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

3 30 Days after end of PT round

Option Year 3 - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time

Period Microbiology Program

1. Microbiology Proficiency Testing Sample Round to each lab

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month

FDA-24-RFQ- 75F40124R0005 Page 16 of 64

2. Electronic report of the lab results for each lab.

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

4 30 Days after end of PT round

Pesticide Program

1. Pesticide Proficiency Testing Sample Round to each lab

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

Option Year 3 - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time

Period

2. Electronic report of the lab results for each lab.

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

2 30 Days after end of PT round

Infant Formula/Adult Nutritional’s Program

1. Infant Formula/Adult Nutritional’s Proficiency Testing Sample Round to each lab participating FDA Labs

3 3-month intervals

2. Electronic report of the lab results for each lab.

3 3-month

FDA-24-RFQ- 75F40124R0005 Page 17 of 64 above for a list of participating FDA Labs

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

3 30 Days after end of PT round

5.2 Contractor Performance Assessment Report

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at https://www.cpars.gov/. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 days from date the evaluation was issued by the FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period in the CPARS system.

Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/webtrain.htm. There is no fee for registration or use of the CPARS.

5.3. Travel Costs And Other Direct Costs

Travel (transportation, lodging, meals and incidental expenses) and ODC costs/pricing shall be included in each of the offeror’s overall task order pricing, noting however, that

(1) costs for travel within the area of Washington, D.C. (i.e., the District of Columbia; Alexandria, Fairfax, and Falls Church Cities, Va,; Arlington, Fairfax, Loudon, and Prince Williams Counties, Va,; and Charles, Montgomery, and Prince Georges Counties, Md.) will not be allowed nor reimbursed, (2) travel costs shall be limited to that authorized by FAR 31.205-46, (3) no fee/profit, overhead, or G&A will be allowed/paid, (4) all travel outside of the Washington, D.C area shall https://www.cpars.gov/ https://www.cpars.gov/webtrain.htm

FDA-24-RFQ- 75F40124R0005 Page 18 of 64 be authorized and requested in advance (minimum of 30 calendar days) to the COR, and (5) the Contractor will be responsible for making all required travel arrangements for its personnel.

5.4. Reporting Matters Involving Fraud, Waste and Abuse

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll-free number is 1-800-HHS-TIPS (1-800- 447-8477). All telephone calls will be handled confidentially. The email address is HHStips@oig.hhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services Attn: HOTLINE 330 Independence Avenue, S.W. Washington, D.C. 20201

5.5 Property, Equipment, Supplies, Facilities, Personnel and Services There shall be no Government furnished property, equipment, supplies, facilities and Government furnished information with this Contract.

6.CONTRACT ADMINISTRATION DATA

6.1 Period of Performance

The anticipated period of performance for this contract consists of Three Years: a Base Year from 6/10/2024 – 6/9/2025 and two option periods 6/10/2025 – 6/9/2026 and 6/10/2026 – 6/9/2027 respectively.

6.2 Observance of Government Closures

Recognized Federal Holidays: Contractor coverage is expected during all Federal workdays.

Except for designated around-the-clock or emergency operations and after-hour courier services, Contractor personnel shall not perform on-site under this contract on Federal holidays or any other day designated as a Federal holiday for the Washington, DC area. No services or deliveries shall be performed at Federal sites on Federal holidays unless specifically requested by the Contracting Officer.

January – New Year’s Day September – Labor Day January – Martin Luther King, Jr. Day October – Columbus Day February – President’s Day November – Veterans Day May – Memorial Day November – Thanksgiving Day June– Juneteenth December – Christmas Day July – Independence Day In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management (OPM) for any reason, the agency is closed, or the Center or FDA building is closed for administrative or safety reasons, the Contractor shall follow

FDA-24-RFQ- 75F40124R0005 Page 19 of 64 directives issued by the Contracting Officer’s Representative (COR) concerning reporting for work.

If adverse weather conditions develop after the Federal Government has opened for normal business, upon notification of early release from OPM, the COR and/or CO will notify the Contractor of Facility closings and specify the time for a final document pickup. Additional specific inclement weather plans may be specified at the task order level.

6.3 Administrative Points of Contract

6.3.1 Contracting Officer’s Representative’s

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of equipment and services to be provided.

The COR is responsible for the following as required by this order: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

6.3.2 The contact information for the Contract Specialist is the following:

Hilda M. Aryeh U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Rd.

Beltsville, MD 20705 Email: Hilda.Aryeh@fda.hhs.gov

6.3.3 The contact information for the Contracting Officer is the following:

Ian Weiss U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Rd.

Beltsville, MD 20705 Email: Ian.Weiss@fda.hhs.gov

6.3.4 The contact information for the Contracting Officer Representative:

Imboden, Louis U.S. Food and Drug Administration

ORA/ORMO/OBFTS/DCG/SCCAB

mailto:Hilda.Aryeh@fda.hhs.gov mailto:Ian.Weiss@fda.hhs.gov

FDA-24-RFQ- 75F40124R0005 Page 20 of 64

Email: louis.imboden@fda.hhs.gov

7. FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

(a) All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

(b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

(c) -----

(1) The Agency will enroll the Contractors new to IPP. The Contractor must follow the

IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

(2) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov.

Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973- 3131.

(3) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

(4) If your company is already registered to use IPP, you will not be required to re-register.

(5) If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

mailto:louis.imboden@fda.hhs.gov http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

FDA-24-RFQ- 75F40124R0005 Page 21 of 64

(d) Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

(a) Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

(1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

- Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

- Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

- Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

- Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

- Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

- Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

- Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

(b) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

- invoice number, amount, & date submitted

- corresponding payment amount & date received

- total amount of all payments received to date under the subject contract or order

- and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

FDA-24-RFQ- 75F40124R0005 Page 22 of 64

(c) Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

(d) If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

(e) Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

(f) The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

(g) Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received.

When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

8. SPECIAL CONTRACT REQUIREMENTS

8.1 Authority To Obligate The Government

The Contracting Officer is the only individual who can legally commit or obligate the Government to the expenditure of public funds. No cost chargeable to the proposed contract can be incurred before receipt of a fully executed contract, task order and/or modification or specific authorization from the Contracting Officer.

8.2. Conflict Of Interest And Confidentiality

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this Contract,

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this Contract.

FDA-24-RFQ- 75F40124R0005 Page 23 of 64

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co-sponsor, joint venture, consultant, or in any similar capacity.

(c) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflicts. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this award for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the award for default or cause; suspend or debar the contractor from Government contracting; or, pursue such other remedies as may be permitted at law or equity.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(f) Prime Contractor Responsibilities. The Contractor shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the Contract or Task Order to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after Contract or Task Order award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants any disclosures identifying any potential organizational conflicts of interest.

(g) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

(h) All contractor personnel involved in this requirement shall abide by the FDA Commitment to Protect Non-Public Information Agreement.

8.3. Non-Personal Services and Inherently Governmental Functions Pursuant to FAR 37.1, no personal services shall be performed under this contract. Work requirements shall flow only from the Contracting Officer or the COR to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All employee

FDA-24-RFQ- 75F40124R0005 Page 24 of 64 assignments, and daily work direction, shall be given by the applicable Contractor supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government Contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change this contract and that if the other Contractor believes this communication to be a direction to change their contract, they shall notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall insure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government’s rights in any way under the other provisions of this contract, including those related to the Government’s right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

8.4 Briefings

An FDA representative (typically, the Contracting Officer’s Representative) will conduct an orientation briefing for the Contractor. The briefing will stress: (1) the importance of protecting non-public information; (2) specified computer/IT requirements; and (3) the consequences of unauthorized disclosure of non-public information. Briefing updates will be conducted annually.

The Contractor shall brief all Contractor employees, subcontractors and consultants regarding the sensitivity of the information to be handled under the contract and of their responsibility to protect

it. The briefing shall stress that the information is non-public and shall not be disclosed to any unauthorized party. The Contractor shall conduct an updated briefing annually and shall submit a report to the FDA COR within ten (10) days after the briefing which includes: an outline of the briefing; copies of any briefing materials; the date the briefing was conducted; and the names of the attendees.

8.5. Tobacco-Free Facilities

In accordance with Department of Health and Human Services (HHS) policy, the Contractor and its staff are prohibited from using tobacco products of any kind (e.g., cigarettes, cigars, pipes, and smokeless tobacco) while on any HHS property, including use in personal or company vehicles operated by Contractor employees while on an HHS property. This policy also applies to all subcontracts awarded under the contract or order. The term ‘‘HHS properties’’ includes all properties owned, controlled and/or leased by HHS when totally occupied by HHS, including all indoor and outdoor areas of such properties. Where HHS only partially occupies such properties, it includes all HHS-occupied interior space.