On-Site Pathology Services

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

This is a request for information along with a sources sought announcement, a market survey for written information only. This is not a solicitation announcement for proposals and no contract will be awarded from this announcement. No reimbursement will be made for any costs associated with providing information in response to this announcement or any follow-up information requests. No telephone calls will be accepted requesting a RFP package or solicitation. There is no RFP package or solicitation. In order to protect the procurement integrity of any future procurement, if any, that may arise from this announcement, information regarding the technical point of contact will not be given.

The U.S. Food and Drug Administration (FDA) is conducting market research to support the National Center for Toxicological Research (NCTR), requirement to provide On-site Pathology Services.

The FDA is seeking sources to determine the availability and capability of businesses capable of providing the required On-site Pathology Services as described herein. All business sources are encouraged to submit capability statements including small business concerns. The following information is provided to assist the FDA in conducting Market Research to identify potential sources for this effort. The announcement is to help the FDA understand the industry best practices and technical solutions capable of providing the full range of services described in this announcement and the draft Performance Work Statement (PWS) as Attachment 1.

The associated North American Industry Classification System (NAICS) Code is 541990 – All Other Professional, Scientific and Technical Services; Small Business Size Standard is $19.5 million.

The FDA/NCTR/ requires On-site  Pathology Services in support of FDA's mission, including but not limited to, the following areas: 1) major services and functional support; 2) gross pathology; 3) histology; 4) pathologist services; 5) clinical chemistry; 6) immunohistochemistry and special procedures; 7) molecular pathology and methods development; 8) digital imaging; 9) data management; 10) archive management (wet tissue and block/slide); 11) internal quality assurance; 12) quality control; and 13) administrative services and management.

Background.  The National Center for Toxicological Research (NCTR) is located at the Jefferson Laboratories of the U.S. Food and Drug Administration (FDA) in Jefferson, Arkansas.  NCTR is an internationally recognized FDA research center that conducts toxicological research studies and other research activities designed to support the FDA’s mission to protect the public’s health. NCTR investigators partner with researchers elsewhere in the FDA as well as other government agencies, industry, and academia. NCTR is comprised of six research divisions and has facilities including: 132 general or special purpose research laboratories; an imaging center; a nanotechnology core facility; and an inhalation toxicology facility. NCTR has AAALAC-accredited animal facilities with animal housing accommodations including conventional housing for rodents, rabbits and large animal species (e.g. NHP, mini-swine), a rodent breeding colony, quarantine facilities for all species, and a zebrafish facility.  On-site pathology services for the animal studies performed at NCTR have been obtained through contracts since the Center’s inception in 1972. 

Place of Performance

All on-site pathology services shall be at 3900 NCTR RD, Jefferson, AR 72079.   

The anticipated performance period is a base year with up to four (4) 1-year option periods.

The respondents shall furnish sufficient technical information necessary for the Government to determine the capability of the respondent at meeting the requirement of this initiative identified above. All interested parties may respond. Responses are limited to twenty (20) pages on 8.5 inch by 11-inch paper. At a minimum, responses shall include the following:

1. Provide a brief corporate profile of your company to include the following:
   1. Business name
   2. SAM Unique Entity ID number
   3. CAGE code
   4. Business address
   5. Business website
   6. Business size status (i.e.: SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB)
   7. Number of employees in your organization
   8. Point of contact name
   9. Mailing address (if different from business address)
   10. Phone number
   11. Email address
2. Describe capability and experience with each of the service areas described in the draft PWS Sections: 4.2.5, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 4.10, 4.11, 4.12, 4.13, 4.14, and 4.15.
3. Are there additional complementary activities that your company would suggest to fully support the FDA’s stated objectives?
4. Please note any additional considerations, changes, additions, updates, or clarifications your company suggests critical to this procurement.
5. Provide any comments to the draft PWS and appendices.
6. Please provide a short narrative explaining how your company would approach providing the range of highly specialized, highly technical data and/or services to the FDA in Jefferson, AR. If applicable, describe how the approach has proven successful in past efforts that are similar to this one in size, scope, and complexity.
7. Possible ways to reduce the cost of the contract.
8. Past performance information on up to three sources within the last three years for the same or similar services as this requirement in which the offeror has provided same or substantially similar solutions and used for same or near-same applications as set forth herein. For each past performance reference include the Contract number, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address.
9. Please describe any recommended performance and customer satisfaction measures and indicators which would give the FDA adequate ability to monitor the quality of the services provided under the anticipated contract.
10. If your company identifies any gaps in the described objectives and scopes, please describe any relevant projects where your company provided the service or support identified and what complementary scientific objectives were achieved.
11. What contract vehicles would your company suggest in acquiring the services outlined in this document (GSA Federal Schedules, Government-wide Acquisition Contract (GWAC), OMB Best in Class Contracts, etc.)?
12. If a small business, demonstrate the firm’s capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting.
13. If a large business, identify the subcontracting opportunities that would exist for small business concerns.
14. Describe your usual contract type, terms and conditions.
15. Although this is not a request for quote, informational pricing for each attached labor category at a fully burdened rate is required.

The government is not responsible for locating or securing any information, not identified in the response.

The Government encourages any comments and/or suggestions from any interested party, regarding the draft PWS. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties must respond with capability statements which are due by email to the point of contact listed below on or before 1:00 pm (Central Time in Jefferson AR) on December 17, 2024 to:  nick.sartain@fda.hhs.gov. Reference: FDA-SSN-2024-126323.

Notice of Intent

Responses to this Sources sought Notice will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate.  Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in sam.gov.  However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response.  The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).