SS-75N94025Q00021.pdf

Eunice Kennedy Shriver National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), is conducting a market survey to determine the availability and technical capability of qualified small businesses, including 8(a) small businesses, small disadvantaged businesses, woman-owned small businesses, service-disabled veteran-owned small businesses or HUBZone small businesses capable of providing C13 labeled vitamin C (L-ascorbic acid) (U-¹³C₆, 98%, Microbiological/Pyrogen Tested).

The objective of this purchase is to obtain Stable isotopes have been used safely in clinical research for decades and have contributed seminal insights into human metabolism. In many cases, stable isotopes allow generation of knowledge that may not be possible by any other method. Under the directive of the NIH Sterile Products for Human Administration (SPHA) executive committee and the NIH Office of Research Support and Compliance (approved 10/2021), stable isotopes used in clinical human metabolic studies must meet outlined minimum requirements.

REQUIRED FEATURES AND SPECIFICATIONS

A single batch of C13 labeled vitamin C (L-ascorbic acid) (U-¹³C₆, 98%, Microbiological/Pyrogen Tested), 0.75g (catalog #: CLM-7283-PK) will be delivered in March 2025.

1. Certificate of Analysis to meet the following requirements in the table below:

Intended for nonsterile / oral use (Raw)

Must have a lot specific Certificate of Analysis (COA)

COA must contain the following information:

1. Lot number

2. Identity

3. Chemical purity

4. Appearance

5. Isotopic enrichment

6. Total impurities %, including heavy metals and total organic carbon

7. Statement that material is not derived from animal/human source or Bovine

Spongiform Encephalopathy / Transmissible Spongiform Encephalopathy testing results

8. All test results shall meet or exceed the vendor’s published specifications including MPT grade materials testing for S. aureus, P. aeruginosa, E. coli, Salmonella sp., aerobic bacteria, yeast, and mold, and for bacterial endotoxins.

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

2. Special packaging with tamper evident shrink wrap seal

3. Individual 30x0.025g in 30ML screwcap amber glass bottles

These stable isotopes are needed for metabolic research protocols that are IRB-approved to meet NIDDK mission and goals. The specific lot is needed because release testing has already been performed and approved by NIDDK sponsor in communication with NIH ORSC. The requirements are based on the “Minimum requirements for stable isotopes used in clinical (human) metabolic studies” version 1.7, by the NIH SHPA executive committee and Office of Research Support and Compliance.

Interested small business firms with the capability and authorization of providing all the required products and services/support shall submit a capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b)whether this procurement will be set-aside for any of the programs described above.

The intended procurement will be classified under North American Industrial Classification (NAICS) code 325414 with a size standard of 1250 employees. All respondents are requested to identify their firm’s size and type of business. Interested firms responding to this market survey must provide (a) capability statement demonstrating their experience, skills and capability to fulfill the Government’s requirements for the above. All respondents must include delivery timeframe.

The capability statement shall be in sufficient enough detail, so that the Government can determine the experience and capability of your firm to provide the products and service/support above. All respondents must be an authorized reseller and must provide documentation confirming authorization and certified capability from the manufacturer to resell/distribute/provide all items/components etc. and services (i.e. training, installation) identified in this notice. Responses to this notice without this confirmation from the manufacturer will not be considered as valid. A copy of the capability statement must be received via email to verne.griffin@nih.gov prior to 11:00 a.m. eastern standard time on December 4, 2024.

Capability statement must reference solicitation# 75N94025Q00021. Submission by email must also reference solicitation # 75N94025Q00021 on the subject line of the email. Any questions must be sent via email to verne.griffin@mail.nih.gov and must include solicitation# 75N94025Q00021 on the subject line of email.

DISCLAIMER AND IMPORTANT NOTES: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in this 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 System for Award Management at www.sam.gov .

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