COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: D-GLUCOSE (U-13C6, 99%), MICROBIOLOGICAL/PYROGEN TESTED

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in 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.

(ii) The solicitation number is NIMH004475RK and the solicitation is issued as a request for proposal (RFP).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-03, with effective date April 26, 2023.

(iv) The associated NAICS code 325199 and the small business size standard is 1250 employees. This requirement is full and open with no set-aside restrictions.

(v) This requirement is for the following item:

The National Institute of Mental Health (NIMH) is seeking D-GLUCOSE (U-13C6, 99%), MICROBIOLOGICAL/PYROGEN TESTED.

(vi) 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 salient characteristics/required features, product specifications and packaging for [U-13C6] glucose . The certificate of analysis and/or the enhanced technical data must meet the following requirements:

Intended for nonsterile / oral use (Raw)

[U-13C6] glucose packaged 25x10gm per vial in screwcap bottles with tamper evident seals

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 / odor
5. Isotopic enrichment
6. Impurity profile with total percent of heavy metals
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
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 – (for microbial enumeration (that includes Total Aerobic Microbial Count / Total Combined Yeast/Molds Count) and absence of Escherichia coli)

The COA provided by vendor must be < 12 months old upon receipt. If not, the Retest Procedure must be initiated and complete prior to acceptance of the raw stable isotope material.

(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated delivery date is 30 days ARO.

(viii) Delivery will be to:

Attn: Mike Kolf

NIH Clinical Center Pharmacy

Investigational Drug Control Unit (IDCU)

10 Center Drive

Bldg 10/Rm 1C230, MSC-1196

Bethesda, Maryland 20892

Email: mkolf@nih.gov

IDCU: 301-496-1031

(ix) The specific salient characteristics/required features, product specifications and packaging for this acquisition are specified in the attached Purchase Description.

(x) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of provision)

The following provisions apply to this acquisition and are incorporated by reference:

• FAR 52.204-7, System for Award Management (Oct 2018)
• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)
• FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Mar 2023)
• FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Dec 2022)
• FAR 52.225-2, Buy American Certificate (Feb 2021)
• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of clause)

The following clauses apply to this acquisition and are incorporated by reference:

• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)
• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)
• FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
• FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (Dec 2022). Addendum to this FAR clause applies to this acquisition and is attached.
• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)
• HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015)

The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal.

• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
• FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020)
• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Mar 2023)
• NIH Invoice and Payment Provisions

(xi) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award decision will be based on a Lowest Price Technically Acceptable (LPTA). In order to be technically acceptable, the product must be in a new condition and meet all the salient characteristics/required features and specifications listed in the attached product description.

(xii) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.

(xiii) The clause at FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (Dec 2022). Addendum to this FAR clause applies to this acquisition and is attached.

(xiv) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

(xv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xvi) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations.

The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All offers must be received by 2:00 p.m., Eastern Time, on May 30, 2023, and reference Solicitation Number NIMH23004475RK. Responses must be submitted electronically to Robin Knightly, Contracting Officer at Robin.Knightly@nih.gov.

Fax responses will not be accepted.

ATTACHMENTS

1. Purchase Description;
2. FAR 52.204-24 (Nov 2021);
3. FAR 52.204-26 (Oct 2020);
4. FAR 52.212-3 (Dec 2022);
5. FAR 52.212-5 (Mar 2023); and
6. IPP Invoice Instructions

Attachments/Links