Attachment_2_SOW_for_IDIQ_(parent).pdf

Attachment 2

RFQ 75N94024Q00094

STATEMENT OF WORK

Metabolic Isotopes IDIQ

1.0 BACKGROUND

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life.

The National Institutes of Health (NIH) Clinical Center Pharmacy mission is to support and conduct clinical research by providing safe, high-quality care - one patient - one medication at a time. The NIH Clinical Center Pharmacy Department provides pharmaceutical care to inpatients and outpatients on NIH intramural research protocols at the NIH Clinical Center. The Clinical Center facility encompasses two hundred (200) inpatient beds, ninety-three (93) day-hospital stations, and fifteen (15) clinics. Clinical Center pharmacy staff provide sophisticated research support to health care providers as well as clinical investigators. Pharmacists conduct and participate in research programs that enhance knowledge regarding investigational drugs and new uses of commercially available agents.

The Pharmacy Department's Investigational Drug Management and Research Section manages investigational drugs through a computerized information system, assists investigators in setting up double-blind studies and filing Investigational New Drug (IND) applications with the Federal Drug Administration (FDA). Pharmacists at the NIH Clinical Center manage commercially available and investigational drugs in approximately one thousand (1,000) research protocols including two hundred (200) blinded studies.

In support of the NIDDK mission, and the mission of the NIH Clinical Center Pharmacy, stable isotopes have been used 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.

2.0 SCOPE

The Contractor shall provide intravenous and oral stable isotopes to NIH and be responsible for sourcing the raw material, packaging and/ or manufacturing the isotope product, and submitting and releasing the product to the NIH after microbial, stability, and analytical testing.

3.0 TECHNICAL REQUIREMENTS

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work (SOW) below. Specifically, the Contractor shall:

Provide isotopes and products such as (but not limited to): D5 glycerol, U-13C6 potassium palmitate, U13C beta hydroxybutyrate, 6,6-D2- glucose, sodium bromide, deuterium oxide 70%, 18O water, D31 palmitic acid, 1-13C palmitic acid, deuterated vitamin E, 13C3 glycerol, 1-13C glucose, 1,2-13C2 glucose, U-13C6 glucose, 1-13C sodium acetate, and U-13C inulin.

Specifications, packaging, certificate of analysis and/or the enhanced technical data package will be required for each batch and details will be provided in each individual Delivery/Task Order issued.

Delivery/Task Orders may include:

Individual production per batch of isotope. The Contractor shall cover the cost for the procurement of raw materials, the production of intravenous isotope products and the microbial and analytical testing to be performed by the Contractor.

Acquisition of oral isotopes. The Contractor shall cover procurement of raw materials, special unit dose packaging, and microbial and analytical testing. Stability testing plans as needed. See example below:

T=0

Stability Storage

Month

Month

Month

Month month month

Identification

HPLC

Conforms

X

Potency

HPLC:

90-110%

X X X X X X X

Appearance:

Clear, colorless solution with no visible particulates

X X X X X X X

Odor No odor X X X X X X X

Sterility Test

USP<71>

Sterile/Negative

X

Endotoxin

USP<85>

<1.00 EU/mL

X

• 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.

• Shipping – Shipment timelines and addresses will be determined per Task/Delivery Order, but most shipments will be to the main NIH campus in Bethesda, Maryland.

4.0 TECHNICAL REPORTING REQUIREMENTS AND DELIVERABLES

Trackable Deliverables:

Number Description Send to Due Date

Annual Report – Including but not limited to;

number of task orders, cost per task order, IDIQ ceiling burn rate & status, issues, resolutions, and lessons learned

CO and COR via Merlin Due Annually

Final Report - Including but not limited to;

final contract period number of task orders, cost per task order, IDIQ ceiling used/remaining; and a summary of the entire contract, including but not limited to;

number of task orders, cost per task order, IDIQ ceiling burn rate & status, issues, resolutions, and lessons learned

CO and COR via Merlin

2 weeks prior to the end of the contract period.

3 Isotopes Proof of Delivery / Packing Slip CO and COR via Merlin

Specified in each task order

4 Sterility Testing Results CO and COR via Merlin

Provided prior to isotope delivery

T=0

Stability Storage

Month

Month

Month

Month month month

Container Closure Integrity Pass X X X X X X X pH Report X X X X X X X

Particulate Matter

USP <788>

Conforms

X X X X X X X

Non-Trackable Deliverables:

Number Description Send to Due Date

1 Notification of events that impact isotope production or delivery CO and COR via email Within 48 hours of the event

2 Maintain requirements for certifications CO and COR via email As needed

All reports required herein shall be submitted in electronic format, via the NICHD Merlin Contract Management System. All electronic contract deliverables shall be submitted via the NICHD Merlin Contracts Contract Management System available at the following website:

Merlin Contract Management System (nih.gov). All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at http://www.hhs.gov/web/508/index.html under "Making Files Accessible." The Contractor must provide to the CO/CS the name of the person(s) submitting electronic reports via the NICHD Merlin Contract Management System in order to initiate access.

https://merlin.nichd.nih.gov/Home.aspx http://www.hhs.gov/web/508/index.html