NICHD-23-133.Combined Synopsis Solicitation.FINAL.pdf

COMBINED SYNOPSIS / SOLICITATION WORKFORM

(1) Action Code: Combined Synopsis/Solicitation

(2) Date: 5/8/2023

(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 (Sodium D3 Hydroxybutyrate) for Metabolic Research

(8) Proposed Solicitation Number: NICHD-23-133

(9) Closing Response Date: 5/10/2023

(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-23-133 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 2023-02 Effective March 16, 2023.

(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 (Sodium D3 Hydroxybutyrate) 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 a 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 Services and Compliance (approved 10/2021), stable isotopes used in clinical human metabolic studies must meet certain specified minimum requirements. 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). A quality agreement was implemented in February 2019 and is in place between Pine Pharmaceuticals, LLC and NIH Pharmacy and NIDDK.

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 of the intravenous stable isotope:

(Sodium D-3-Hydroxybutyrate, 97% Chemical Purity, 13C4, 99%, Microbiological/Pyrogen Tested) for Metabolic Research from Pine Pharmaceuticals, LLC for 1 batch. The Contractor 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. The contract with Pine Pharmaceuticals, LLC will encompass purchasing Sodium D-3-Hydroxybutyrate (130.06g/mol) and compounding to supply 400 vials; 80mol/ml (30 ml vial).

4.0 SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

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.

The total project costs are as follows:

1. Individual production quotes per batch of Sodium D-3-Hydroxybutyrate, 97% Chemical Purity, 13C4, 99%, Microbiological/Pyrogen Tested reconstituted with sterile normal saline to concentration of 80µmol/ml in 30ml vial (200 unit vials for clinical research use). The quote should cover the cost for the procurement of raw materials, the production of the intravenous isotope product at Pine and the microbial and analytical product testing to be performed by a third-party vendor.

Once the isotope is formulated into its finished dosage form it is tested for the following:

1. Appearance/odor

2. Particulate matter (USP <788>)

3. Sterility (per USP <71> or method approved by NIH)

Sterilizing filter integrity (bubble point) unless terminally sterilized by a different compendial method.

4. Bacterial Endotoxins (USP <85>), FDA Pyrogen and Endotoxin Testing (June 2012 Guidance)

5. Identity

6. Potency (utilizing validated methods)

A beyond use date (BUD) should be assigned by the qualified processing vendor.

Beyond use date is based upon stability and storage data as below.

2. Stability testing for the final formulated Sodium D-3-Hydroxybutyrate for a 2-year period. The testing recommended is:

Base Period

Option 1

Option 2

T=0

Stability Storage

3 mth 6 mth 9 mth 12 mth

18 mth

24 mth

27 mth

Identification

HPLC

Conforms X

Potency

HPLC:

90-110% X X X X X X X

Appearance:

Clear, colorless solution with no visible particulates

Odor No odor X X X X X X X X

Sterility Test

USP<71>

Sterile/Negative

Endotoxin

USP<85>

<1.00 EU/mL pH Report X X X X X X X X

Particulate Matter X X X X X X X

USP <788>

Important Notes:

The raw material and finished product requirements are outlined in The NIH Minimum requirements for stable isotopes used in clinical (human) metabolic studies, V1.7 (November 2022).

The raw material Sodium D-3-Hydroxybutyrate, 97% Chemical Purity, 13C4, 99%, Microbiological/Pyrogen Tested must be obtained from Cambridge Isotope Laboratories – Catalog number: CLM-3853-MPT-PK. An example quote is attached.

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.

Task Areas:

Task Area 1 – Delivery Timelines – The anticipated delivery date is 60 - 90 days after receipt of award. The deliverables include, but are not limited to:

Deliverable Deliverable Due Date Final formulated and vialed product

180 days after execution of the contract

Manufacturing Documents and Records:

• Certificate of Analysis

• Summary Report of the Production, Testing, and Characterization

• Batch Records for Manufacture

• Test Result Reports

• Raw Material and

Equipment Certificates of Analysis

• Environmental Monitoring Reports

• Exception and Resolution Reports

180 days after execution of the contract (drafts for review two weeks prior to finalization)

Deviation, Discrepancy or Out-Of-Specification Reports

Within 48 hours of the incident

Revised Deliverables (includes all end-products and report deliverables requiring modification by the Contractor). Revised

Within a mutually agreed upon period deliverables shall be completed by the Contractor at the Contractor’s expense unless otherwise indicated Progress Reports Monthly Stability Time Point Reports Within 2 weeks of completed testing

Task Area 2 – Shipping: Contractor shall arrange shipment to the National Institutes of Health, Department of Pharmacy, Building 10, Room 1C230, MSC, 10 Center Drive Bethesda, MD 20892-1196.

Task Area 3- Sourcing- The Contractor 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 and provide certificate of analysis.

5.0 PURCHASE ORDER TYPE

This Purchase Order is to be a firm fixed price.

6.0 PERIOD OF PERFORMANCE AND PAYMENT BREAKDOWN

The anticipated period of performance for this requirement is:

Base Period: June 30, 2023 – June 29, 2024 Option Period 1: June 30, 2024 – June 29, 2025 Option Period 2: June 30, 2025 – September 30, 2025

Payment breakdown for services is in arrears, as services are rendered. Payment terms per the vendor allowance being a small business is a net 30-days after receipt of order

(ARO).

7.0 INSPECTION AND ACCEPTANCE

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

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

(vii) 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:

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.

The total project costs are as follows:

1. Individual production quotes per batch of Sodium D-3-Hydroxybutyrate, 97% Chemical Purity, 13C4, 99%, Microbiological/Pyrogen Tested reconstituted with sterile normal saline to concentration of 80µmol/ml in 30ml vial (200 unit vials for clinical research use). The quote should cover the cost for the procurement of raw materials, the production of the intravenous isotope product at Pine and the microbial and analytical product testing to be performed by a third-party vendor.

Once the isotope is formulated into its finished dosage form it is tested for the following:

1. Appearance/odor

2. Particulate matter (USP <788>)

3. Sterility (per USP <71> or method approved by NIH)

Sterilizing filter integrity (bubble point) unless terminally sterilized by a different compendial method.

4. Bacterial Endotoxins (USP <85>), FDA Pyrogen and Endotoxin Testing (June 2012 Guidance)

5. Identity

6. Potency (utilizing validated methods)

A beyond use date (BUD) should be assigned by the qualified processing vendor. Beyond use date is based upon stability and storage data as below.

2. Stability testing for the final formulated Sodium D-3-Hydroxybutyrate for a 2-year period. The testing recommended is:

Base Period

Option 1

Option

T=0

Stability Storage

3 mth 6 mth 9mth 12 mth

18 mth

24 mth

27 mth

Identification

HPLC

Potency

HPLC:

90-110%

Appearance:

Clear, colorless solution with no visible particulates

Odor No odor X X X X X X X X

Sterility Test

USP<71>

Sterile/Negative

Endotoxin

USP<85>

<1.00 EU/mL pH Report X X X X X X X X

Particulate Matter

USP <788>

Important Notes:

The raw material and finished product requirements are outlined in The NIH Minimum requirements for stable isotopes used in clinical (human) metabolic studies, V1.7 (November 2022).

The raw material Sodium D-3-Hydroxybutyrate, 97% Chemical Purity, 13C4, 99%, Microbiological/Pyrogen Tested must be obtained from Cambridge Isotope Laboratories – Catalog number: CLM-3853-MPT-PK. An example quote is attached.

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 – The anticipated delivery date is 60 - 90 days after receipt of award. The deliverables include, but are not limited to:

Deliverable Deliverable Due Date Final formulated and vialed product

180 days after execution of the contract

Manufacturing Documents and Records:

• Certificate of Analysis

• Summary Report of the

Production, Testing, and Characterization

• Batch Records for Manufacture

• Test Result Reports

• Raw Material and Equipment

Certificates of Analysis

180 days after execution of the contract (drafts for review two weeks prior to finalization)

Shipping The contractor shall arrange shipment to National Institutes of Health, Department of Pharmacy, Building 10, Room 1C230, MSC, 10 Center Drive Bethesda, MD 20892-1196

Sourcing- The Contractor 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 and provide certificate of analysis.

Evaluation Criteria Acceptable Unacceptable

Technical The services proposed by the vendor meet the requirements in the SOW

Summary Overall Rating (Overall Risk)

Cost/Price 1. Offerors will be evaluated based upon cost/price completeness and accuracy to determine the validity of the price, realism, reasonableness, and risk.

• Environmental Monitoring Reports

• Exception and Resolution Reports Deviation, Discrepancy or Out- Of-Specification Reports

Within 48 hours of the incident

Revised Deliverables (includes all end-products and report deliverables requiring modification by the Contractor). Revised deliverables shall be completed by the Contractor at the Contractor’s expense unless otherwise indicated

Within a mutually agreed upon period

Progress Reports Monthly Stability Time Point Reports Within 2 weeks of completed testing

Technical Evaluation Rating Definitions

(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

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:

Rating Definition Acceptable Proposal meets requirements and indicates an adequate approach and understanding of the requirements, and risk of unsuccessful performance is no worse than moderate.

Unacceptable Proposal does not meet requirements of the solicitation, and thus, contains one or more deficiencies, and/or risk of unsuccessful performance is unacceptable.

http://www.acquisition.gov/

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

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

Vendor/Contractor Must be able to accept payments via IPP (Invoice Processing

Platform) The contractor may submit a request for an exception. See below for IPP, IPP helpdesk information and applicable Health and Human Services addendum clause.

INVOICING PROCESSING PLATFORM (IPP) In compliance with the Office of

Management and Budget (OMB) M-15-19 memorandum "Improving Government Efficiency and Saving Taxpayer Dollars through Electronic Invoicing" directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors. Invoices submitted under any award resulting from this solicitation will be required to utilize the Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests" IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury's Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis (FRSTL). Respondents to this solicitation are encouraged to register an account with IPP if they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register however, we encourage you make sure your organization and designated IPP user accounts are valid and up to date. The IPP website address is:

https://www.ipp.gov If you require assistance registering or IPP account access, please contact the IPP Helpdesk at (866) 973-3131 (M-F 8AM to 6PM ET), or IPPCustomerSupport@fiscal.treasury.gov Note: Should an Offeror feel that use of the IPP would be unduly burdensome, the response to this solicitation should include an explanation of this position for a determination by the contracting officer.

HHSAR 352.232-71 Electronic Submission of Invoice Payment Requests (Feb 2022) will apply when this requirement is solicited and awarded. As stated: (a) Definitions.

As used in this clause, Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request. (END OF CLAUSE)

(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