Sol_Doc_docx.docx .pdf

Food and Drug Administration (FDA)

Solicitation No: FDA-23-SOL-116650A

Center for Food Safety and Applied Nutrition (CFSAN)

Issue Date: September 5, 2023

NAICS Code: 541714 - Professional, Scientific, And Technical Service

Contents

BACKGROUND

1.1 Notice of Combined Synopsis/Solicitation

1.2 Notice of FAC

1.3 Notice of NAICS/Set Aside

1.4 Contract Type

DESCRIPTION OF REQUIREMENT/STATEMENT OF WORK

2.1 Scope of Work

2.2 Technical Requirements; Chemical Analysis:

2.2.2 Collection of food samples:

2.3 Standard analyte analysis per price list

2.4 Data reporting

2.5 Reports/Deliverables

PRICES/COST

CONTRACT TYPE AND MINUMUM/MAXIMUM AMOUNT

4.1 Contract Type

4.2 Minimum And Maximum Contract Value

4.3 MINIMIM AND MAXIMUM TASK ORDER AMOUNT:

PRICING AND ORDERING OF SERVICES

CONTRACT ADMINISTRATION DATA

6.1 Period Of Performance

6.3 Observance of Government Closures

6.4 Contracting Officer (CO)

6.5 Contract Specialist (CS)

Contracting Officer’s Representatives (COR)

7.1.Contracting Officer’s Representative’s Authority:

7.2 IDIQ Contracting Officer’s Representative (IDIQ COR)

7.2.1 Task order contracting officer’s representative (TO COR)

7.3 Task Order Project Managers (TO PMS)

7.4 Technical Direction

Payment And Invoicing Procedures Government Furnished Property

5.1.1 Government Furnished Equipment (GFE)

5.1.2 Information Technology (IT) Help Desk Support

5.1.3 Government Furnished Information

5.1.4 Contractor Equipment Requirements

Government Furnished Data

5.1.5 Post-Award Evaluation of Contractor Performance

FDA-SPECIFIC CONTRACT REQUIREMENTS

10.1 Non-Personal Services and Inherently Governmental Functions

10.2 Additional Security And Confidential Requirements

10.3 Reporting Matter Involving Fraud, Waste And Abuse

10.4 Contractor Conformance With Applicable Laws, Regulation, Policies, And Standards

10.5 Contractor Advertising of Contract Award

CONTRACT CLAUSES

FAR 52.252-2 – Clauses Incorporated by Reference (Feb 1998)

12 HHSAR Clauses Incorporated By Reference

FAR Clauses In Full Text

9.1.1 FAR 52.216-18 – Ordering (Aug 2020)

9.1.2 FAR 52.216-19 – Order Limitations (Oct 1995)

9.1.3 FAR 52.216-22 – Indefinite Quantity (Oct 1995)

9.1.4 FAR 52.217-8 – Option to Extend Services (Nov 1999)

9.1.5 FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000) FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (June 2023)

(End of clause) HHSAR Clauses In Full Text

9.1.6 HHSAR 352.237-75 – Key Personnel (Dec 2015)

9.1.7 HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

Solicitation Provisions

14.1.1 FAR 52.252-1 – Solicitation Provisions Incorporated by Reference (Feb 1998)

Provisions Incorporated by Reference:

FAR 52.216-1 – Type of Contract (Apr 1984)

14.2 Offeror Representation And Certifications

14.3 FAR 52.212-3 Offeror Representations and Certifications-Commercial Items (DEC 2022)

14.4 FAR 52.209-7 – Information Regarding Responsibility Matters (Oct 2018)

PROPOSAL INSTRUCTIONS

Solicitation Inquiries and Questions

15.1 Proposal Submission Due Date

Proposal Format And Instructions

15.1.1 General Format of Proposals

15.1.2 Cover Letter

15.2 Volume I-Technical Proposal

15.2.5 Volume II, Factor 3 -Cost/Price (Business) Proposal

15.3 General Proposal Information

15.3.1 Release of Information

15.3.2 Preparation Costs

10.3.3 Restrictions on Disclosure

BASIS FOR AWARD AND EVALUATIONS FACTORS

16.1 FAR 52.212-2 Evaluation—Commercial Products and Commercial Services (Nov 2021)

16.2 Evaluation Factors

List of Attachments

BACKGROUND

CFSAN is required to produce information about the nature of chemical contaminants in food. Over the past several years, the agency has faced a wide range of issues related to direct and indirect contamination of food that have required information on the concentrations of specific chemicals. In many cases, the type of information required is a survey of the concentrations of contaminants to provide CFSAN with information necessary to formulate policy and to assess potential risks. In the past, this information has been provided by scientists within CFSAN:

i) Through small scale in-house surveys;

ii) Through contracts with outside laboratories and

iii) Through surveys conducted by the FDA's Office of Regulatory Affairs on behalf of CFSAN.

The information from these surveys is not used for direct regulatory action but is instead used to make decisions about scientific issues associated with food safety problems and to guide policy. For example, surveys in the past were used to inform the agency about the nature of acrylamide concentrations in food, and were followed in 2011-2014 by a larger study, done by a contract laboratory, which established the concentrations of acrylamide in a larger set of representative types of foods. This information was used to develop guidance about ways to reduce the occurrence of acrylamide in foods. Future studies shall examine how guidance and policy have affected the concentrations of this chemical in foods. In 2011- 2014, contract laboratory analysis was also used to assess concentrations of inorganic arsenic in rice and rice products, as well as fruit juices, to obtain information used in developing risk assessments. Similar surveys were conducted to assess concentrations of 4- methylimidazole (4-MEI), potassium bromate, semicarbazide and color additives in various foods, to address different programmatic needs within CFSAN. It is anticipated that CFSAN will continue to have such needs over the next five years.

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) 2023-04, effective June 02, 2023.

(https://www.acquisition.gov/).

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 541714 - Professional, Scientific, And Technical Service. 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.

1.4 Contract Type

This is an indefinite delivery- indefinite quantity contract. The FDA anticipates Firm-Fixed Price Task Orders to be issued under this IDIQ.

DESCRIPTION OF REQUIREMENT/STATEMENT OF WORK

The U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), and its various offices nationwide, including the Office of Regulatory Science (ORS), the Office of Food Safety (OFS), the Office of Food Additive Safety (OFAS) and the Office of Compliance (OC), has a need to obtain information about the concentrations of chemicals in a wide variety of foods, dietary https://www.acquisition.gov/ https://beta.sam.gov/ supplements and cosmetics, through the collection of food, dietary supplements and cosmetic samples, and their subsequent analysis by chemical analytical methods to be specified in each task order.

2.1 Scope of Work

The objective of this contract is to develop a capability to support CFSAN's research by rapidly assessing the quantities of specified chemicals in foods, dietary supplements, and cosmetics through surveys of these commodities. The purpose of these surveys is to develop a better understanding of the quantities of chemicals and their distribution. The types of samples to be collected for these studies include food products from across the United States, including fresh fruits and produce, packaged and processed foods of all types, dietary supplements, and cosmetics. The analytical targets of these studies include chemical contaminants in foods (e.g. pesticides, industrial chemicals), direct food additives and indirect food additives (those produced by processing or transfer from packaging), deliberate adulterants, nutrients, naturally occurring chemical components (such as metallic elements), as well as the chemical constituents of dietary supplements, botanical extracts and cosmetics. The analytical methodology for any specified study will be established and provided by CFSAN, and shall include methods based upon state-of-the-art analytical techniques, including many based on instrumental analysis with various types of separation techniques and spectrometers. The Contractor shall at all times, throughout the life of this contract, possess an ISO 17025 Accreditation or equivalent.

2.2 Technical Requirements; Chemical Analysis:

The Contractor shall provide all services necessary or incidental to the chemical analysis services requested by the FDA at CFSAN. In addition, the Contractor shall furnish the necessary professional personnel, materials, services, facilities, and do all things necessary for or incidental to the performance of the work.

Task orders shall include, but not be limited to the following:

CFSAN will specify the types of samples, quantities (between 50 and 1500), analytical methodology and data reporting requirements with each specified task.

The Contractor shall perform the following tasks:

2.2.1 Sample Collection:

Collect raw, minimally processed (e.g. bagged), and processed/packaged foods, dietary supplements and cosmetics from local supermarkets and stores in major metropolitan areas in some parts of the United States. Cities chosen may include the metropolitan areas of Atlanta, Chicago, Dallas, Denver, Los Angeles, New York, San Francisco, Seattle and Washington, DC. CFSAN shall specify the type of commodity, the brand distribution, lot number and manufacturing date distribution, quantity and geographic location of the samples. While the geographic distribution is not expected to be extensive, the ability to obtain samples from major metropolitan areas is required.

2.2.2 Collection of food samples:

• Samples may be collected with specific requirements as to geographic location.

• Sample collection may occur in different geographic areas in cases where there are significant regional variations in the way foods are processed.

• In some cases, there may not be a requirement to collect samples at different locations.

For some types of questions, it is sufficient that national brands be purchased from multiple lots, but as long as the lot requirements are met, they could all be purchased from the same place.

• Sample Collection Costs: Sample collection costs are to be priced in a way that the cost per sample is known at the time the task is awarded.

• Sample logging: When samples are collected, the following information will be obtained.

(a) Sample numbers assigned by FDA or by the Contractor.

(b) Name of the product and size of the package (e.g., Diet Coke, 2 liters).

(c) Date and location of sampling.

(d) Readable digital photographs or photocopies of the food packaging, as purchased, to include front of package, nutrition information panel and ingredient list. The Contractor shall retain all product packages for the analyzed food products until FDA deems the digital photographs to be acceptable.

(e) Record of lot numbers/production codes and expiration dates (where applicable).

(f) Serving size from product label.

(g) Sampling portion where applicable (e.g., center or heel slice of bread, whole breaded fish fillet as packaged, a composited frozen dinner).

2. When samples are collected, digital photographs shall be obtained for each item collected:

(a) Collected items shall be assigned a sample ID #, which shall be carried throughout the entire analysis process.

(b) Photographs shall be taken of the front of the items so that the specific items and brand are clearly identifiable.

(c) Photographs shall be taken of the ingredients panel and the Nutrition Facts label, as well as the Uniform Product Code (UPC).

(d) Photographs shall be taken of preparation instructions, if the samples are to be prepared by the vendor.

(e) All digital photographs shall be available in BMP, JPG or similar digital format. Each digital photograph shall be named in such a way that the Sample Identification

Number (SIN) occurs at the beginning of the file name.

(f) The Contractor shall be able to upload the digital photographs to an FDA-selected site using FTP or similar protocol.

ii) In some cases, the Contractor shall be asked to prepare foods, according to package instructions, prior to analysis. Minimum suggested food preparation facilities (or access thereto) include mixers, pans, cookie sheets, utensils, fryers and ovens to prepare cakes, cookies, not ready to eat foods that shall be cooked in the oven (French fries, snack foods, etc). In such cases, foods will be prepared as they would normally be consumed (e.g., all frozen meals cooked, and dry mixes prepared according to package directions prior to analysis), unless otherwise directed by CFSAN. Food preparation steps should be documented. A brief description of the sample processing (e.g., homogenization, filtration, extraction, sample size) of each sample, prior to analysis, shall be recorded and included in sample data.

iii) If CFSAN sends samples to the Contractor directly, CFSAN shall be responsible for the cost of shipping.

(1) An update of the sample collection status for any particular task shall be provided in a spreadsheet at the end of each month, together with the monthly reports requested in Section 4 (c).

2.3 Standard analyte analysis per price list.

The Contractor shall perform analysis of samples for analytes specified in the standard price list.

The number of analyses identified in the task order shall include the maximum number of collected samples to be analyzed. The Contractor shall use a Quality Control plan or similar method that shall be specified with each task order.

1 A calibration curve shall be generated before, during or after each set of analyses, per the Contractor's usual procedures (which shall be outlined in the response). The Contractor shall bear the cost of generating the calibration curve (s).

2. Spike recoveries shall be performed by addition of standards to the food matrix every 20th sample. If less than 20 samples are analyzed for a food category, spike recoveries shall be determined on at least one sample in the food type category. Spike concentrations shall be specified in the task order under the QA/QC plan, but in general spike concentrations will be at the midpoint for the working range for the contaminant in question. At a minimum, the value calculated for the recovery must be within ± 25% of the expected recovery. If the recoveries are not acceptable, appropriate actions should be taken and the spike recovery should be re-determined (vendor to assume the cost). The amount (concentration or mass) of analyte added to the sample shall be reported with the results in order to allow an independent determination of the recovery.

3. A calibration check standard shall be analyzed every 10th sample to monitor retention time and quantitative accuracy. (At a minimum, calibration check samples shall fall within the 95% confidence limits determined from the standard curve). The calibration check standard shall be run at a concentration that is near the mid-point of the analytical calibration curve. If there is a failure to meet this criterion, appropriate actions shall be taken and the standard shall be re-analyzed.

Additional failures require that a new calibration curve (Contractor assumes the cost) be prepared and all samples prior to the QC failure to be re-analyzed. The true value (i.e., expected value) of the calibration check should be reported with the results to allow for an independent determination of the QC result.

4. For each separate food category (as defined by CFSAN when the task order is placed), replicate (duplicate or triplicate) analysis of a sample will be perfom1ed as specified in the task order. The replicate analyses will occur at either the 20th sample within the food category or approximately mid-way through the list of samples for a particular food category (if a food category contains less than 20 samples). The relative standard deviation for the results shall be less than 15%.

5.The Contractor, for purposes of quality control, may run their own standardized QC spike sample (at their own expense).

6. Failure of any of QA/QC samples to meet method performance measures shall require an explanation of what was done to connect the method and shall require reanalysis of the samples analyzed prior to loss of method control measures.

7. The Contractor shall provide CFSAN with a control chart for the QC samples.

2.4 Data reporting.

In general, the Contractor shall report data from analysis according to the procedures outlined below, on a monthly basis. The Monthly Report shall also include an update of the sample collection status for any particular task. More information on data reporting shall be provided in each task order.

• Reports (as specified in the assigned analytical method requested) shall be provided to CFSAN at the end of each month (on the Last Business Day). Description of report format and content shall be specified at the time of order but will be similar to that described below.

Whenever possible, all samples for a particular food category should be purchased, analyzed, and results provided together. The following minimum data rep011ing requirements shall be met:

• Results and Certificates of Analysis (COA). At the end of each month (on the Last Business Day), a results Spreadsheet (Excel), raw data files, quantitation files and photocopies or photographs of product packaging, and analysis of a specified sample set (food type, group, etc, as specified in each task order, shall be provided. COAs, spreadsheets, raw data and product package photos will be uploaded to a server that CFSAN will provide and identify.

• The Contractor's Results Spreadsheet (in Excel described above) shall include the following information:

1. Assigned Sample Number (ASN).

2. COA number on which the sample appears

3. Name of the product (For quantitation check standards, concentration or quantity can be used in place of the product name or a separate column can be used to show this information).

4. Size of the package.

5. Date of purchase.

6. Location of purchase.

7. Lot number or production code.

8. Expiration date (if applicable).

9. Serving size from product label.

10. Sampling portion where applicable ( e.g., center or heel slice of bread, whole breaded fish fillet as packaged, a composited frozen dinner).

11. Analytical results in appropriate units (typically mg/kg or µg/kg) of the analyte in the food as consumed.

12. For each spike analysis, information on the amount spiked, the result, and the percent recovery

13. File name or link for digital photographs of product label (front of package, nutrition information panel and ingredient list).

14. Raw data file name for each sample number (may be the same for multiple samples, but shall include raw data for calibration curves used to generate quantitative results)

15. Quantitation file name if separate quantitation files are generated

2.5 Reports/Deliverables

The Contractor shall provide the reports (including an update of the sample collection status for any particular task) on the Last Business Day of each month, and reported to FDA on Certificates of Analysis (COA) and in results spreadsheets, to the FDA Contracting Officer's Technical Point of Contact (TPOC). Task Orders shall specify the collection of a number of samples and the analysis of those samples. The deliverables shall be certificates of analysis and results spreadsheets for the specified analyses. For example, a task order might specify the collection of 400 samples and analysis of 400 samples plus the associated QA/QC samples (80 additional analyses.

2.5.1 Format of Monthly Report (MPR):

A report of results shall be submitted (as Certificates of Analysis, on a spreadsheet containing results to date, data files and photos) on monthly intervals by the (Last Business Day .of the month), beginning from the contract award date unless otherwise stated on the task order. The report shall be in the following format:

a. A cover page containing:

b. Contract Number and Title; and Task Order Number

c. Type of report, sequence number of repo11, and period of performance being reported;

d. Contractor's name and address;

e. Name of Author(s); and

f. Date of report

A summary of the samples collected to date for each task, CO As, results spreadsheets, raw data files, quantitation files and photographs submitted in the current report, with the files names and the type of analysis performed.

Spreadsheets with summaries of the results obtained in the previous month, to be fom1atted as noted in section 2.4.C. l .b (Contractors Results Spreadsheet), Certificates of Analysis, Raw Data Files, Quantitation files and label photographs.

Fl. Marking Instructions for Reports The Contractor shall mark each shipment with its organizational name, contract number, item number, and quantity (indicate partial or final shipment). As appropriate, note on the face page of the report and when feasible on the binding (1) "one volume only" or (2) "volume 1 of 2, volume 2 of 2" etc.

F2. Payment of Postage and Fees All postage and fees related to distribution of deliverables, including forms, reports, etc. shall be paid by the Contractor

G. Analytical Methods

The following table is provided for informational purposes regarding the analytical methods required:

Nos.

Test description

LIMS code

Metho d

Detection Limit

1 2-acetyl-4-tetrahydroxy-butylimidazole (THI) (impurity in caramel color)

4M EI Global Internal Method 1 ppb-liquids

5-solids

2 Acrylamide ACRYLA M-LC US FDA July 23, 2002

LC/MS/

MS

10 pp b

3 Amino Acid analysis AMINO-CMPL (Includes standard profile plus cystine, praline, hydroxyproline, tryptophan)

AMINO-STD

(Includes alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, phenylalanine, methionine, serine, threonine, tyrosine, valine)

USDA MSS2

(1993)

USDA MSS2

(1993)

0.01%

4 Arsenic (total) ARSENIC-MS FDA EAMS 4.7 0.01 ppm

Arsenic (Inorganic)

AS-SPECIAT

FDA EAMS

4.10, 4.11

LODs: Total Arsenic:

lOppb, Organic Arsenic: 3ppb, Inorganic Arsenic: 6ppb

Benzene

SOLV-SINGL

Internal GC Headspace

0.1 ppm

BHA/BHT (antioxidants)

JAOAC 1996

BHA-T-TBHQ 79(6):1459-

1 ppm

Bisphenol A

BISPHENOLA

CFSAN

LC/MS/MS

5 ppb

Cadmium

CADMIUM-MS

FDA EAMS 4.7

1 ppb

Caffeine

CAFFEINE

Internal Method

Chloramphenicol/Nitrofura n metabolites

NFCAP-MS

LIB4597

1 ppb

Chondroitin sulfate

CHOND-HPLC

JAOAC Int 90:659 (200/lnternal)

49 mg/kg

Cyanuric acid

MELAMINE

FDA 4421/Mod

CFIA LC-

MS/MS

0.25 ppm

Deoxynivalenol (DON)

VOMl-LC-HI

CFSAN

Method (LC-

MS/MS)

10 ppb

15 Ephedrine alkaloids EPHEDRINE USP/NF Current Ver.

0.05 mg/g

FD&C Color Additives

COLOR-FDA

Liquid chromatograph y;

"Determination of Seven Certified Color Additives in Food Products Using Liquid Chromatograph y"; Harp, BP;

Miranda- Bermudez, E;

Barrows, JN;

Journal of Agricultural and Food Chemistry, 61(15), 3726-3736

<1 ppm

Glucosamine

GLUCOSAMIN

AOAC 2005.01

Gluten

ALLERGLIAD

r-Biopharm RS Ridascreen Test, MIOBS

ELISA

2.5 / 40 ppm gliadin, 5 ppm gluten

Hexanal

HEXANAL

Internal GC

0.2 ppm

5-hydroxymethyl-2-furfural (5- HMF) (impurity in caramel color)

4MEI

Global Internal Method

1 ppb-liquids 5-solids

Inorganic elements (multiple, up to 5 per analysis);

option for multiple element pricing

ICPMS-HMS

EPA

3050/6020, USP730

Iodine

IODINE-MS

4.13

0.1 ppm

Lead

LEAD-MS

FDA EAMS 4.7

0.01 ppm

Melamine

MELAMINE FDA 4421/Mod

CFIA LC-

0.25 ppm

4-methylimidazole (4-

MEI)

4MEI

Global Internal

1 ppb-liquids 5-solids

28 Mercury MERCURY-MS FDA EAMS 4.7 0.005 ppm

29 Milk Allergens ALLERG-MLK Neogen Veratox Test, MIOBS ELISA

2.5 / 25 ppm

Multiple mycotoxins (aflatoxin Bl, deoxynivalenol-

DON,

fumonisin Bl, ochratoxin A, T-2 toxin, zearalenone

CFSAN LC-

MS/MS

Varies per Compound:

Aflatoxin Bl - 0.5 ppb Aflatoxin B2 - 0.3 ppb Aflatoxin Gl - 0.7 ppb Aflatoxin G2 - 0.9 ppb

Deoxynivalenol (DON) - 10 ppb

Fumonisin Bl - 4 ppb

Fumonisin B2 - 10 ppb Ochratoxin A (OTA) •

0.8 ppb

MYCOTOXIN

CSAN Method

(LC-

MS/MS)

T-2 Toxin - 9 ppb Zearalenone (ZEA) - 7 ppb

34 Multi-class aquaculture:

phenicols, beta lactams, fluoroquinolones, quinolones, sulfonamides, tetracyclines, macrolides, lincosamide, triphenyl methane dyes, and anthelmintics

VETDRUGS-MS

LIB 4653

1-100 ppb

Nitrate/nitrite

N02-N03

ISO 14673

0.1 ppm, 0.2 ppm

Perfluorooctanoic acid (PFOA)/Perfluorooct anesul fonate (PFOS)

Miscellaneous

CFSAN LC-

35 Pesticides

(chlorinated/organop hospha te)

PEST-MR

FDA GC-

MS/MS and

LC-MS/MS

<0.005 ppm

Peanut allergens

ALLERGPNUT

Neogen Veratox Test, Phthalates (BBP, DBP, DEHP, DNOP, DINP, DIOP, DHEXP and DCHP)

PHTHAL-EST

Internal

0.3-lowfat liquids,

1.5 ppm- solids & high fat liquids

Potassium bromate

BROMATE-MS

CFIA SOM-

DAR-CHE

043-02

4 ppb

Semicarbazide

SEM-LCMS

JAFC 2008,

56, 2064-

5 ppb

Sesame allergens

ALLERGSES

and rBiopharm

ELISA

10 ppm

Sodium benzoate

BENZ-SORB

JAOAC

1985:68 488

1 ppm

Soy allergens

ALLERG-SOY

Neogen Veratox Test

Thallium

THALLIUM-MS

4.7

0.01 ppm

Trans-fat and fatty acid profiles

FAT-BY-FAP

AOAC 996.06

0.10%

Thiamine

(vitamin Bl)

THIAMN-USP

USP/NF

Current Ver.

0.1 mg/lOOg

PRICES/COST

See the attached pricing schedule

CONTRACT TYPE AND MINUMUM/MAXIMUM AMOUNT

4.1 Contract Type

It is anticipated that a single-award Indefinite Delivery-Indefinite Quantity (IDIQ) type Contract, per FAR 16.5. It is anticipated that most of the individual orders issued against this IDIQ will be Firm Fixed Price (FFP). All deliverables will be clearly identified, completed with proper description, due date, and at a predetermined, agreed-upon price.

4.2 Minimum And Maximum Contract Value

IDIQ Minimum

The minimum guarantee for this IDIQ is $500.00, which will be obligated on this IDIQ award.

IDIQ Maximum

The maximum aggregate dollar value of all task orders awarded to all awardees over the 5-year ordering period of this IDIQ is anticipated to be $750,000.00 pending the results of the solicitation.

4.3 MINIMIM AND MAXIMUM TASK ORDER AMOUNT:

The minimum Task order amount shall be $5,000.00 and the maximum Task Order amount shall be $750,000.00.

PRICING AND ORDERING OF SERVICES

5.1 Description of Supplies & Services

5.2 Ordering

A request for task order proposal (RFTOP) will be issued via email for individual task orders. Task orders against the IDIQ contract will be issued via email and will be in accordance with FAR 16.505 and FAR clause 52.216-18.

5.2.1 Ordering Procedures

Any Contracting Officer of the Food and Drug Administration (FDA) is authorized and may place orders under this IDIQ contract. Each individual task order will describe the specific performance requirements for data

Vitamin D

VIT-D2-D3

AOAC 2011.11

Vitamin D2 = 9.1 mcg/100g

Vitamin D3 = 6.6 mcg/lOOg

Solicitation No: FDA-23-SOL-116650 Contract for Sampling and Analysis volume and timeliness and may include required reporting processes and/or document handling procedures.

When a need for services within the scope of this IDIQ contract arises, the process for issuing task orders is as follows:

1. All proposal evaluations will follow the terms and conditions of each RFTOP.

2. The Contractor will typically have a minimum of ten (10) business days, unless otherwise specified, to provide a proposal in response to the RFTOP. The proposal shall include:

a. Brief description of the technical approach to the task order requirements

b. Price buildup (extended pricing, total task order pricing, and concurrence with the anticipated contract type)

c. Resumes of any key personnel identified in the RFTOP

2. The FDA will evaluate the task order proposal for technical acceptability and price reasonableness. If the FDA has questions or concerns, the Contracting Officer will contact the Contractor and may request a revised proposal.

3. If the task order proposal is determined acceptable, the Contracting Officer will issue a task order. All task orders will, at a minimum, include the following:

a. Task Order number

b. Date of Task Order

c. Funding for the Task Order

d. Task order SOW and specific deliverables and due dates

e. Task order pricing

f. Period of performance of the task order

g. Any terms, conditions and instructions specific to the task order

Any work that the Contractor undertakes prior to receiving a fully executed task order that has been signed by the Contracting Officer (or the Contractor has received prior authorization to proceed from the Contracting Officer) shall be solely at the Contractor’s own risk.

5.2.2 Pricing of Orders

a. Proposals submitted in response to a RFTOP must be in accordance with the Ordering Period rates in the IDIQ Price Schedule based on the performance start date of the task order, and that rate must be used for the duration of the task order performance period. The Contractor may propose lower rates in response to a

RFTOP.

b. RFTOPs may include ordering periods in accordance with FAR clause 52.217-9. However, ordering periods must utilize the Ordering Period rates listed in the IDIQ Price Schedule, based on the performance start date of the option period.

These Ordering Pricing terms and conditions apply to all task orders issued against this IDIQ contract.

5.2.3 Emergency orders

In emergency situations or other times when it is not practical to prepare a written work plan prior to the commencement of work, the Contracting Officer may verbally authorize performance to commence immediately, so long as the work to be performed in the emergency situation is within the scope of this contract. In those instances, a written work plan shall be submitted within 10 days following the authorization to commence work. When work is authorized to commence prior to the submission and negotiation of a work plan, the Contracting Officer will indicate, at time of authorizing work, a dollar ceiling that may not be exceeded except at the Contractor's own risk.

CONTRACT ADMINISTRATION DATA

6.1 Period Of Performance

The anticipated period of performance for this contract is five (5) years.

6.2 Place of Performance

The place of performance shall be at the contractor’s facility.

6.3 Observance of Government Closures

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

6.4 Contracting Officer (CO)

Contracting Officer’s Authority: The Contracting Officer is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is, or may be, outside the scope of the contract. In the event the Contractor effects any changes to this contract or contracts at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The CO will be the only individual authorized to accept nonconforming work, waive any requirement of the contract/task order and modify any term or condition of the contract/task order.

The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer.

Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The following person is the Contracting Officer for this contract:

Ian Weiss Office of Acquisitions and Grants Services 4041 Powder Mill Road Beltsville, MD 20705

Email: Ian.Weiss@fda.hhs.gov

6.5 Contract Specialist (CS)

The Contract Specialist supports the Contracting Officer. The following person is the Contract Specialist:

Hilda Aryeh Office of Acquisitions and Grants Services 4041 Powder Mill Road Beltsville, MD 20705 Email: Hilda.Aryeh@fda.hhs.gov mailto:Ian.Weiss@fda.hhs.gov mailto:Hilda.Aryeh@fda.hhs.gov

Contracting Officer’s Representatives (COR) 7.1.Contracting Officer’s Representative’s Authority:

The Contracting Officer (CO) may designate other Government personnel, known as the Contracting Officer’s Representative (COR) to act as his or her authorized representative for contract administration functions which do not involve changes to the scope, price, schedule, or terms and conditions of the contract. The designation will be in writing, signed by the Contracting Officer, and will set forth the authorities and limitations of the representative(s) under the contract. Such designation will not contain authority to sign contractual documents, order contract changes, modify contract terms, or create any commitment or liability on the part of the Government different from that set forth in the contract. CORs do not have authority to act as agent of the Government under the contract or task order. The Government may unilaterally change its COR designation.

7.2 IDIQ Contracting Officer’s Representative (IDIQ COR)

The IDIQ COR, to be designated at time of contract award, will represent the Government for the purpose of the IDIQ. The IDIQ COR will be responsible for the following:

• Tracking compliance with Limitations on Subcontracting clause across task orders

• Tracking and monitoring contract ceiling

• Tracking and monitoring staff allocation across task orders

• Reviewing changes to staffing matrix

• Secondary point of contact for issues that need to be escalated

• Reviewing Task Order SOWs for scope compliance

• Completing annual CPARs evaluations

The following person has been identified as the IDIQ COR:

TBD at time of contract award

7.2.1 Task order contracting officer’s representative (TO COR) For each individual task order, a Task Order (TO) COR will be assigned. The TO COR will serve as the Contractor’s first point of contact for any technical questions and is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; (5) assisting in the resolution of technical problems encountered during performance; and (6) providing technical direction; and, (7) reviewing and approving invoices/vouchers.

7.3 Task Order Project Managers (TO PMS)

Task Order project managers may assist the CORs, but will not have the authority to provide technical direction as described in Section 6.9; however, they may be responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) performing technical evaluation as required; (3) performing technical inspections and acceptances then reporting to the COR of the acceptance as required by this performance; and

(4) reviewing of invoices/vouchers.

7.4 Technical Direction

Performance of the work under this contract shall be subject to the technical direction of the COR. The term “technical direction” is defined to include, without limitation, the following:

• Directions to the Contractor which redirect the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual statement of work.

• Provision of information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work description.

• Review and, where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

Technical direction must be within the general Scope of Work stated in the contract. The COR does not have the authority to and may not issue any technical direction which:

• Constitutes an assignment of additional work outside the general Scope of Work of the contract.

• Constitutes a change as defined in the applicable contract clause FAR 52.212-4.

• Change any of the expressed terms, conditions, or specifications of the contract.

All technical direction will be issued in writing by the COR or will be confirmed by him/her in writing within five (5) business days after issuance.

If, in the opinion of the Contractor, any instructions or direction issued by the COR is within one of the categories described above, the Contractor shall not proceed but shall notify the Contracting Officer in writing within 5 working days after the receipt of any such instructions or direction and shall request the Contracting Officer to modify the task order, accordingly. Upon receiving such notification from the Contractor, the Contracting Officer will issue an appropriate contract modification or advise the Contractor in writing that, in his/her opinion, the technical direction is within the scope of this contract. The Contractor shall proceed immediately with the instructions or directions and shall be subject to the “Disputes” clause within FAR 52.212‐4(d), Contract Terms and Conditions – Commercial Items.

Payment And Invoicing Procedures This contract incorporates the following clause(s) by reference:

• FAR 52.232-1 Payments (Apr 1984) All invoicing will be in accordance with Health and Human Service Acquisition Regulation (HHSAR) Clause 352.232-71 Electronic Submission of Payment Requests (Feb 2022) and the following:

Specific invoicing instructions may be provided in each individual task order. Unless otherwise specified in the task order, the FDA Invoicing procedures are as follows:

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.

(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.

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

(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.

(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.

Government Furnished Property Specific Government furnished property will be identified in each individual task order.

The Contractor shall return all Government furnished property to the property custodian (COR) no later than the expiration date of this contract or any task order.

In addition to the requirements of FAR clause 52.245-1, Government Property (Jan 2017) incorporated in this contract, the Contractor shall comply with the provisions of HHS Publication, "HHS Contracting Guide for Control of Government Property," which is incorporated into this contract by reference. This document can be accessed at: https://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf

5.1.1 Government Furnished Equipment (GFE)

FDA may provide laptops, tower computers, printers, scanners, copier, data cable line, and basic PC desktop images and Center Software Top‐Offs for FIRF in individual task orders. Upon receipt of FDA badges, FDA will provide Contractor FDA network access to staff under this contract. FDA will provide access to any server‐based environment necessary to accomplish the stated work.

The Contractor shall work with the FDA Help Desk Support to relocate/install all GFE to ensure no breaks in current work performance.

Upon the expiration of the one-year manufacturer’s warranty for the Government Furnished Equipment (GFE), the Contractor shall be responsible for maintaining all GFE equipment in accordance with current commercial operating standards until replaced or returned to the FDA.

The Contractor shall be responsible for providing any supplies necessary to operate the GFE (other than maintenance/repair supplies).

https://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf

5.1.2 Information Technology (IT) Help Desk Support

Help Desk Support will be provided by the FDA for only FDA functions inclusive of support for all Government Furnished Property (GFP) and software. FDA’s Help Desk is responsible for distributing new and replacement laptops as they are needed and configuring laptops with standard and Center specific software. FDA Help Desk Support will be provided through remote access, drop‐in support, or when the Contractor transports the equipment to the nearest FDA IT servicing location. Drop‐in support services include: transition‐in services and support for major technology changes that cannot efficiently be accomplished remotely. Upon request by FDA Help Desk Support, the Contractor shall be responsible for transporting the items in need of repair to and from the designated FDA facility for repair. In addition, the FDA’s Help Desk provides best effort support – defined as basic troubleshooting ‐ for peripheral equipment connected to FDA owned computers. FDA does not grant the Contractor administrative rights for Government‐ owned computers. If required, the Contractor shall submit a request for administrative rights using the Form 3530 and submit to FDA for approval.

5.1.3 Government Furnished Information

Government Furnished Information will be accessible through the FDA network and paper copies, as needed.

The Contractor shall inform and require staff to comply with Government regulations that prohibit the use of any Government property for personal use. The FDA will not supply the Contractor with phones. The FDA will provide the data drops (if not pre‐existing or extras are needed) and network infrastructure (e.g. DS3 circuit, network switch, network router) for connection to the FDA network, via the Verizon direct connection between the Contractor’s facility and the FDA WO Campus. The applicability of Appendix 6A or 6B will depend on the Contractor’s existing network closet.

5.1.4 Contractor Equipment Requirements

The FDA Master Approved Technology (MAT) list contains a list of software applications and equipment approved by the Office of Information Management (OIM). The approved technologies are determined to be compatible with FDA’s Technical environment. The MAT list is posted on FDA’s intranet and will be available after contract award). In addition, FDA posts a list of technologies not approved by OIM on the intranet.

All Contractor peripheral equipment connected to FDA computers or laptops must be on the MAT List. If Contractor equipment and software is not on the MAT List, it must be approved via the formal FDA technical approval process prior to connection to FDA’s network.

The Contractor shall be responsible for identifying needed technologies that are not provided by the FDA.

FDA has instituted the Information Technology Information Management (ITIM) approval process in order to track technologies across the Agency. The introduction of a new technology or a different version of an already approved technology requires the submission and approval of an ITIM request. The Contractor may be responsible for supporting the ITIM process including writing and submitting ITIM requests and tracking them from inception through completion. FDA Center IT Investment Review Boards may need to be included in a coordinated review process.

Government Furnished Data The Government…