Sources Sought Notice.docx

SAM.gov

SOURCES SOUGHT NOTICE

Title: Purchase U-13C glucose for human study

NAICS CODE: 325199 – All Other Basic Organic Chemical Manufacturing

Classification Code: H168 Chemicals and Chemical Products

Size Standard: 1,250 Employees

Description.

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality.

For equipment/supply requirements, responses must include the place of manufacturing (i.e., address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e., address Non-Manufacturer Rule).

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

Background.

Stable isotopes have been used safely in clinical research for decades and have contributed seminal insights into human metabolism. Magnetic Resonance Spectroscopy (MRS) Section and Core have been conducting research projects using carbon-13 (13C) labeled glucose to study brain metabolism of healthy volunteers for more than ten years.

MRS detects nuclear magnetic resonance signals from nuclei in human tissue. Common MRS detect signals from protons which are dominant nuclei in living tissues. 13C MRS detect signals from carbons instead of protons, which can provide different information of metabolism.

Because natural abundance of 13C is only one percent, signals from natural 13C is too weak to be detected. Thus, we need to administrate 13C enriched chemicals into human subjects to increase 13C signal intensity.

In an ongoing project, [U-13C6] glucose will be used. The glucose will be prepared into 20% solution for oral administration. Each human study will use 40-50 grams of [U-13C6] glucose depending on the body weight of the subject. With the administration of 13C labeled glucose, we should be able to measure 13C signals in a reasonable period of time.

Purpose and Objectives.

This SOW is for the procurement of [U-13C6]glucose for metabolic research. The manufacturer should produce the isotope product and ship the product to the NIH Clinical Center Pharmacy after microbial and analytical testing.

The [U-13C6]glucose will be used to prepare oral solution at the concentration of 20% (weight/volume) by the NIH Clinical Center Pharmacy. The amount of solution is determined by the body weight of the subject at the dose of 0.75g glucose per kg body weight.

Salient characteristics include the following.

Under the directive of the NIH Sterile Products for Human Administration (SPHA) Executive Committee and the NIH Office of Research Services and Compliance (approved 10/2021), stable isotopes used in clinical human metabolic studies must meet certain specified minimum requirements.

Below are the NIH requirements for product specifications and packaging. The certificate of analysis and/or the enhanced technical data should meet the following requirements.

1. 200 gm of [U-13C6]glucose, MPT grade packaged in 10 gm per vial, 20 vials total.

2. [U-13C6]glucose, MPT grade should be packaged in 10 gm per vial with screwcap bottles with tamper evident shrink wrap seal. Intended for nonsterile / oral use (raw).

COA for both aqueous and non-aqueous raw material must contain the following information:

1. Lot number

2. Identity

3. Chemical purity

4. Appearance / odor **

5. Isotopic enrichment

6. Total impurities (%), including heavy metals (total or individual)

7. Statement that material is not derived from animal/human source or BSE/TSE testing results

8. All test results shall meet or exceed the vendor’s published specifications

9. Raw material (for non-sterile use) can be the finished product if the research indication is appropriate for its use.

10. Meet USP <1111> standards for non-sterile drugs – (microbial enumeration that includes TAMC, TCYMC and an absence of E. Coli)

Please Note – the testing described in items 10, 11 & 12 may be superseded if the raw material is sterilized (usually by terminal filtration) and treated like a sterile product, subdividing aliquots in a clean room environment and testing an appropriate sampling of the

Anticipated period of performance.

12 months

Government Responsibilities.

The government’s responsibilities involve providing feedback to the contractor if a problem arises.

Data Rights.

The Government shall have unlimited rights to, and ownership of all deliverables provided under this contract, including reports, recommendations, briefings, work plans and other deliverables. (FAR Clause 52.227-17 Rights in Data- Special Works).

Delivery or Deliverables.

N/A

Capability statement /information sought.

Companies that believe they possess the capabilities to provide the required products should submit documentation of their ability to meet each of the project requirements to the Contracting Officer.

The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.

Please note that NINDS is particularly interested in small business sources. If you are a small business, please state the type of small business (small business; HUBZone; service-disabled, veteran-owned; 8(a); veteran-owned; woman-owned; or small disadvantaged businesses) and your size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

In case domestic sources are available and capable of fulfilling the Government’s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25.

One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.

The information submitted must be in an outline format that addresses each of the elements of the project requirements and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required.

The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, or references, if requested.

The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

All responses to this notice must be submitted electronically to the Contract Specialist.

Facsimile responses are NOT accepted.

The response must be submitted to Joe Kennedy at e-mail address joseph.kennedy@nih.gov.

The response must be received on or before March 27, 2024, 5:00pm Eastern Time.

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 presolicitation synopsis and solicitation may be published in www.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).