NICHD-23-079.Combined Synopsis Solicitation.FINAL.pdf

COMBINED SYNOPSIS / SOLICITATION WORKFORM

(1) Action Code: Combined Synopsis/Solicitation

(2) Date: 2/8/2023

(3) Year: 2023

(4) Contracting Office Zip Code: 20892

(5) Project Service Code: 6505 - DRUGS AND BIOLOGICALS

(6) Contracting Office Address:

6710B Rockledge Drive Bethesda, MD 20892

(7) Subject/Title: Acquisition of Intravenous Stable Isotope (D5 Glycerol, 6,6 D2-Glucose) for Metabolic Research

(8) Proposed Solicitation Number: NICHD-23-079

(9) Closing Response Date: 2/10/2023

(10) Contact Point: Amber Harris

(11) Contract Award and Solicitation Number: TBD

(12) Contract Award Dollar Amount: TBD

(13) Contract Line Item Number(s): TBD

(14) Contractor Award Date: TBD

(15) Contractor Name: TBD

(16) Description: (Background)

(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; quotes are being requested and a written solicitation will not be issued.”

(ii) The solicitation number is NICHD-23-079 and the solicitation is issued as a request for quote (RFQ).

(iii) The solicitation document, the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-01 effective 12/30/2022.

(iv) The associated NAICS code is 325414, Biological Product (except Diagnostic)

Manufacturing, and the small business size standard is 1,250. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13.

(v) The Contractor Requirements are listed below:

1.0 PURCHASE ORDER TITLE

Acquisition of Intravenous Stable Isotope (D5 Glycerol, 6,6 D2-Glucose) for Metabolic Research

2.0 BACKGROUND

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. Prior to 2015, all intravenous sterile isotopes used for metabolic research at the NIH Clinical Center (CC) were produced and dispensed by the NIH CC Pharmaceutical Development Service (PDS). After the PDS closure in June 2015, NIDDK investigators worked with the NIH CC Pharmacy and developed a standard operating procedure (SOP) for procuring intravenous isotope compounding at Pine Pharmaceutical LLC, an FDA-registered 503b compounding pharmacy. Pine pharmaceuticals was initially approved by the NIH Office of Deputy Director of Clinical Care in August 2016 and the decision re-affirmed by the NIH Sterile Products for Human Research Committee (SPHA) on July 24th, 2018. The decision to continue using Pine Pharmaceuticals, LLC followed extensive year-long vetting and an external audit commissioned by the NIH CC Office of Research Support and Compliance (ORSC).

This SOW proposal, initiated on behalf of principal investigators of NIDDK, is to engage Pine Pharmaceuticals in a term-limited contract for the procurement of intravenous stable isotopes for metabolic research. Pine Pharmaceuticals, under the directive of the NIH SPHA executive committee, will be responsible for sourcing the raw material, manufacturing the sterile intravenous isotope product, and submitting and releasing the product to the NIH CC Pharmacy after microbial and analytical testing.

3.0 OBJECTIVE

The objective of this acquisition is to procure:

• intravenous stable isotope of (D5 Glycerol) from Pine Pharmaceuticals for 2 batches of 30 vials per batch (11.7mg/mL; 30mL vial). The 2022-2023 year-long contract with Pine Pharmaceuticals will encompass 2 batch deliverables (for example, a batch of D5 Glycerol will be delivered ~ every 4 months).

• intravenous stable isotope of (6,6 D2-Glucose) from Pine Pharmaceuticals for 2 batches of 30 vials per batch (72.9mg/mL; 30mL vial). The 2022-2023 year-long contract with Pine Pharmaceuticals will encompass 2 batch deliverables (for example, a batch of 6,6 D2-Glucose will be delivered ~ every 4 months).

4.0 SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

Intravenous Stable Isotope (D5 Glycerol):

The following isotopes will be needed, which include the following specifications and packaging. The certificate of analysis and/or the enhanced technical data package should meet the following requirements for the most recently manufactured lot with date.

Costs shall be based on individual production quotes per batch of D5 Glycerol (30 vials for clinical research use). The Contractor shall cover the cost for the procurement of raw materials, the production of the intravenous isotope product at Pine and the microbial and analytical testing to be performed by a third-party vendor.

Important Notes:

Minimum requirements for stable isotopes used in clinical (human) metabolic studies, V1.4.

The raw material Glycerol (1,1,2,3,3-D5, 99%), Microbiological/Pyrogen Tested must be obtained from Pine Pharmaceuticals – Catalog number: DLM-1229-MPT-PK

These stable isotopes are needed for metabolic research protocols that are Internal Review Board (IRB) approved to meet NIDDK mission and goals. The requirements stated above are based on the minimum specifications for stable isotopes used in clinical (human) metabolic studies by the NIH SPHA Executive Committee and Office of Research Services and Compliance. Specific isotope requirements can be found in Attachment A.

Intravenous Stable Isotope (D5 Glycerol) Task Areas:

Task Area 1 – Delivery: Contractor shall deliver the described supplies in two shipments between February 28, 2023 to September 30, 2023

Task Area 2 – Shipping: Contractor shall arrange shipment to the below specified location no later than 60-90-days after receipt of award (ARO). The orders will be shipped to:

IDCU

Investigational Drug Control Unit National Institutes of Health, Department of Pharmacy Building 10, Room 1C230, MSC 10 Center Drive Bethesda, MD 20892-1196 Office: 301-496-1031

All information contained in the table below must be complete and present on the outside label of the box and the packing slip of Investigational Drug Products shipped to the NIH Clinical Center Pharmacy Department:

Pharmacy Contact Name Sanaz Kiana

NIH Protocol Number

17-DK-0013

76-DK-0006

17-DK-0054

000756-DK

Address and Phone Number

NIH Clinical Center Pharmacy Department Building 10, Room

1C230, MSC 1196

10 Center Drive Bethesda, MD 20892- Phone: 301-496-1031

FAX: 301-402-3268

sanaz.kiana@nih.gov

Investigational Drug Control Unit (IDCU) will accept investigational drugs during business hours (8:30 am to 5 pm) Monday through Friday.

Task Area 3- Sourcing- The vendor shall be responsible for sourcing the raw material, packaging and/ or manufacturing the isotope product, and submitting and releasing the product to the NIH Clinical Center Pharmacy after microbial and analytical testing.

Intravenous Stable Isotope (6,6 D2-Glucose):

Costs shall be based on individual production quotes per batch of 6,6 D2-Glucose (30 vials for clinical research use). The Contractor shall cover the cost for the procurement of raw materials, the production of the intravenous isotope product at Pine and the microbial and analytical testing to be performed by a third-party vendor.

Important Notes:

The raw material and finished product requirements are outlined in Appendix A. Minimum requirements for stable isotopes used in clinical (human) metabolic studies, V1.7.

The raw material D-Glucose (6,6-D2, 99%) Microbiological/Pyrogen Tested must be obtained from Pine Pharmaceuticals – Catalog number: DLM-349-MPT-PK

These stable isotopes are needed for metabolic research protocols that are Internal Review Board (IRB) approved to meet NIDDK mission and goals. The requirements stated above are based on the minimum specifications for stable isotopes used in clinical (human) metabolic studies by the NIH SPHA Executive Committee and Office of Research Services and Compliance.

Independently, and not as an agent of the Government, the contractor shall provide the intravenous stable isoptopes.

Specifically, the NIDDK requires completion of the following tasks:

Intravenous Stable Isotope (6,6 D2-Glucose) Task Areas:

Task Area 1 – Delivery Timelines – February 2023-September 2023.

Task Area 2 – Shipping Instructions – Shipping will be arranged by NIH CC Pharmacy mailto:sanaz.kiana@nih.gov and Pine Pharmaceuticals. The orders will be shipped to:

IDCU

Investigational Drug Control Unit National Institutes of Health, Department of Pharmacy Building 10, Room 1C230, MSC 10 Center Drive Bethesda, MD 20892-1196 Office: 301-496-1031

All information contained in the table below must be complete and present on the outside label of the box and the packing slip of Investigational Drug Products shipped to the NIH Clinical Center Pharmacy Department:

Pharmacy Contact Name Sanaz Kiana

NIH Protocol Number

17-DK-0013

76-DK-0006

17-DK-0054

000756-DK

Address and Phone Number

NIH Clinical Center Pharmacy Department

Building 10, Room 1C230, MSC 1196 10 Center Drive

Bethesda, MD 20892-1196 Phone: 301-496-1031

Investigational Drug Control Unit (IDCU) will accept investigational drugs during business hours (8:30 am to 5 pm) Monday through Friday.

5.0 PURCHASE ORDER TYPE

This Purchase Order is to be a firm fixed price.

6.0 INSPECTION AND ACCEPTANCE

Inspection and acceptance will be performed at the place of installation - National Institutes of Health, NIDDK, 9000 Rockville Pike, Maryland 20892.

(i) Period of Performance: Within 365 Days of Award

(viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

(ii) The provision at FAR clause 52.212-2, Evaluation – Commercial Items, is applicable.

Award will be made to the contractor providing the most advantageous quote to the Government. Technical factors and price considered with technical factors outweighing price.

Specifically, the following technical factors will be evaluated:

i. The award will be made to the contractor who provides the most advantageous quote to the Government and will be evaluated via a comparative analysis of the quotes provided, technical factors and price considered.

The technical factors are as follows:

Intravenous Stable Isotope (D5 Glycerol):

The following isotopes will be needed, which include the following specifications and packaging. The certificate of analysis and/or the enhanced technical data package should meet the following requirements for the most recently manufactured lot with date.

Costs shall be based on individual production quotes per batch of D5 Glycerol (30 vials for clinical research use). The Contractor shall cover the cost for the procurement of raw materials, the production of the intravenous isotope product at Pine and the microbial and analytical testing to be performed by a third-party vendor.

Attachment A contains the specifics of the isotopes needed.

Important Notes:

Minimum requirements for stable isotopes used in clinical (human) metabolic studies, V1.4.

The raw material Glycerol (1,1,2,3,3-D5, 99%), Microbiological/Pyrogen Tested must be obtained from Pine Pharmaceuticals – Catalog number: DLM-1229-MPT-PK

These stable isotopes are needed for metabolic research protocols that are Internal Review Board (IRB) approved to meet NIDDK mission and goals. The requirements stated above are based on the minimum specifications for stable isotopes used in clinical (human) metabolic studies by the NIH SPHA Executive Committee and Office of Research Services and Compliance.

Delivery Timelines – Contractor shall make two deliveries of the described supplies between February 28, 2023 to September 30, 2023. The First 60-90 days ARO and the last prior to September 30, 2023.

Shipping – Contractor shall arrange delivery of the first shipment to the below specified location no later than 60-90-days after receipt of award (ARO).

IDCU

Investigational Drug Control Unit National Institutes of Health, Department of Pharmacy Building 10, Room 1C230, MSC 10 Center Drive Bethesda, MD 20892-1196 Office: 301-496-1031

All information contained in the table below must be complete and present on the outside label of the box and the packing slip of Investigational Drug Products shipped to the NIH Clinical Center Pharmacy Department:

Pharmacy Contact Name Sanaz Kiana

NIH Protocol Number

17-DK-0013

76-DK-0006

17-DK-0054

000756-DK

Address and Phone Number

NIH Clinical Center Pharmacy Department Building 10, Room

1C230, MSC 1196

10 Center Drive Bethesda, MD 20892- Phone: 301-496-1031

Investigational Drug Control Unit (IDCU) will accept investigational drugs during business hours (8:30 am to 5 pm) Monday through Friday.

Sourcing- The vendor shall be responsible for sourcing the raw material, packaging and/ or manufacturing the isotope product, and submitting and releasing the product to the NIH Clinical Center Pharmacy after microbial and analytical testing.

Intravenous Stable Isotope (6,6 D2-Glucose):

The following isotopes will be needed, which include the following specifications and packaging. The certificate of analysis and/or the enhanced technical data package should meet the following requirements for the most recently manufactured lot with date.

Costs shall be based on individual production quotes per batch of 6,6 D2-Glucose (30 vials for clinical research use). The Contractor shall cover the cost for the procurement of raw materials, the production of the intravenous isotope product at Pine and the microbial and analytical testing to be performed by a third-party vendor.

Important Notes:

The raw material and finished product requirements are outlined in Appendix A attached.

Minimum requirements for stable isotopes used in clinical (human) metabolic studies, V1.4.

The raw material D-Glucose (6,6-D2, 99%) Microbiological/Pyrogen Tested must be obtained from Pine Pharmaceuticals – Catalog number: DLM-349-MPT-PK

These stable isotopes are needed for metabolic research protocols that are Internal Review Board (IRB) approved to meet NIDDK mission and goals. The requirements stated above are based on the minimum specifications for stable isotopes used in clinical (human) metabolic studies by the NIH SPHA Executive Committee and Office of Research Services and Compliance.

See Appendix A for Isotope specifications

Delivery Timelines – Contractor shall deliver the described supplies between February 28, 2023 to September 30, 2023.

Shipping – Contractor shall arrange shipment to the below specified location no later than 60-90-days after receipt of award (ARO).

Sanaz Kiana Investigational Drug Management & Research Section Outsourcing Unit (IDOU) National Institutes of Health, Department of Pharmacy Building 10, Room 1C230, MSC 10 Center Drive Bethesda, MD 20892-1196 Office: 301-496-1031

Sourcing- The vendor shall be responsible for sourcing the raw material, packaging and/ or manufacturing the isotope product, and submitting and releasing the product to the NIH Clinical Center Pharmacy after microbial and analytical testing.

ii. The Contracting Officer will make a price reasonableness determination on technically acceptable quotes.

(x) FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

(xi) FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

(xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition. Including the following clauses and Prohibitions:

i. 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C.

644)

ii. 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r))

iii. 52.219-28, Post Award Small Business Program Representation

iv. 52.222-3, Convict Labor (June 2003) (E.O. 11755).

v. 52.222-19, Child Labor—Cooperation with Authorities and Remedies

(Jan 2014) (E.O. 13126).

vi. 52.222-21, Prohibition of Segregated Facilities

vii. 52.222-26, Equal Opportunity

viii. 52.222-36, Equal Opportunity for Workers with Disabilities

ix. 52.222-50 Combating Trafficking in Persons

x. 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving

xi. 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83)

xii. 52.225-13, Restrictions on Certain Foreign Purchases http://www.acquisition.gov/

Additional Clauses:

i. 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332)

ii. 52.232-39, Unenforceability of Unauthorized Obligations

(xiii) Additional Contract Requirements: None

(xiv) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable.

(xv) Offers shall be submitted via email to amber.harris@nih.gov

(17) Place of Contract Performance:

National Institute of Health, NIDDK 10 Center Drive

Bethesda, MD 20892

(18) Set-aside Status: This requirement is set aside for small business.

mailto:amber.harris@nih.gov