12-19-2024 Sources Sought Notice.pdf

FDA Regulated Products Sampling Services Ref No. 75F40125R00032

This is not a solicitation announcement. This is a Sources Sought Notice (SSN) only. This SSN is issued solely for market research and planning purposes – it does not constitute a Request for Quotations (RFQ) or a promise to issue an RFQ in the future. Further, the SSN does not commit the Government to contract for any supply or service whatsoever. The FDA is not seeking proposals and will not accept any unsolicited proposals. Responders are advised that the U.S.

Government will not pay for any information or administrative costs incurred in response to this SSN; all costs associated with responding to this SSN will be solely at the expense of the interested respondents. Not responding to this SSN does not preclude participation in any future RFP, if issued. The purpose of this sources sought synopsis is to gain knowledge of potential qualified vendors to include large business sources, small business sources and their size classifications (i.e., HUBZone 8(a), 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran- Owned, Women-Owned Small Business, and Small Disadvantaged Business) relative to the North American Industry Classification System (NAICS) code.

Responses to this Sources Sought Notice will be used by the Government to make appropriate determinations about potential sources.

Project Title: FDA Regulated Products Sampling Services

Project Description:

The FDA, or U.S. Food and Drug Administration, is responsible for ensuring the safety and efficacy of food, drugs, medical devices, and other products in the United States. The sample collection process is an important component of the FDA's regulatory oversight activities. The FDA collects samples of regulated products ready for consumption or sale, as well as in-process and raw ingredient samples, to monitor and evaluate these products for potential adulterants, or to verify the accuracy of product labeling.

Sample collection involves taking physical samples of products from warehouses, distributors, retail locations, ports of entry, or other designated holding facilities for laboratory analysis. The products being sampled may be produced in the U.S. or may be of foreign origin and have been imported into the U.S., including products originally produced in the U.S. before being exported and re-imported back into the U.S.

The results of sample collection and testing will be used by the FDA to ensure the safety and quality of products, expand knowledge of FDA regulated products and areas of concern through surveillance, and used to make regulatory decisions, such as pursuing voluntary recalls or initiating official FDA operations.

The FDA has several business objectives for sampling activities under this contract, such as:

• Collect samples as part of FDA’s surveillance sampling program used to gather data on FDA-regulated products.

• Aid FDA’s sampling efforts of items offered for import, while in import status or after release.

• Provide FDA’s laboratories with a reliable and consistent stream of samples for analysis.

Instructions for Responses:

Your responses to the questions provided below will assist the Government in selecting the appropriate acquisition method. Page limit: Maximum 15 pages (font size Times New Roman 11 or larger). A copy of the company capability statement will also be accepted (but not in place of the responses to the below questions). The anticipated period of performance is a 12-month based period, with one 12-month option period. After review of the responses received, a pre-solicitation synopsis and formal solicitation may be published on SAM.gov.

Responses to this notice must include company name, address, point of contact, size of business pursuant to the NAICS code, and must respond to the following questions:

1. Is your business a small business under the NAICS code?

2. Does your firm qualify as a Small Disadvantaged Business?

3. If disadvantaged, specify if your firm is certified under Section 8(a) of the Small

Business Act?

4. Are you considered a certified HUBZone firm?

5. Are you considered Woman-Owned or operated business?

6. Are you a certified Service-Disabled Veteran-Owned or Veteran-Owned business?

7. Do you have the ability to conduct the sampling required under this contract nationwide?

a. If not, what geographic regions can you cover?

b. Would you be able to collect the samples within 2 business days in this geographic region or nationwide?

8. Please list which FDA Programs you can conduct sampling for, as applicable under the

Federal Food, Drug, and Cosmetic Act? Examples include, but are not limited to: Human and Animal Foods, Pharmaceuticals, Tobacco Products, etc.

9. Would you share your pricing structure for performing sampling tasks?

10. Are there additional labor categories you would expect to see on the task orders?

11. Are there additional positions that should be included?

12. Are there applicable certifications which should be required?

13. What certifications does your company hold?

14. What certifications do your samplers hold?

15. What training courses have your samplers taken for this type of work?

16. Do you create or produce FDA regulated products or services?

17. Do you offer sampling services to companies that handle FDA regulated products?

Included is a draft Statement of Work that is inclusive of the anticipated Task Areas (Attachment A).

1. All interested parties can provide written opinions/questions on the draft Statement of Work.

2. All opinions/questions expressed should focus on strengthening the draft Statement of

Work Tasks to ensure industry understands and comprehends the government’s requirements.

This is not a request for proposals and in no way obligates the Government to award any contract. Responses to this notice shall be emailed to Nicholas Bisher, Contracting Officer at Nicholas.Bisher@fda.hhs.gov and Amanda Lusk at Amanda.Lusk@fda.hhs.gov. Responses must be received in writing, by no later than January 9, 2025, 12:00PM ET.

No solicitation is currently available. Responses to this sources sought synopsis will not be considered adequate responses to the solicitation, a request to be added to a prospective offerors list, or a request to receive a copy of the solicitation. Ref. No. 75F40125R00032.

Attachments:

Attachment A: Draft Statement of Work mailto:Nicholas.Bisher@fda.hhs.gov mailto:Amanda.Lusk@fda.hhs.gov