75N94024Q00094_SSN_Metabolic_Isotopes_1.pdf

SMALL BUSINESS SOURCES SOUGHT NOTICE

AGENCY: The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)

TITLE: Metabolic Isotopes

PROPOSED SOLICITATION NUMBER: 75N94024Q00094

PROJECT SERVICE CODE: 6505 – Drugs and Biologicals

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of all qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses;

and (3) their size classification according to the North American Industry Classification System, (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set- aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

The anticipated North American Industry Classification System (NAICS) code for this acquisition is – 325412 – Pharmaceutical Preparation Manufacturing, size 1300 employees.

The acquisition contract type is anticipated to be Firm Fixed Price.

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.

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.

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 services below.

Specifically, the Contractor shall:

Provide isotopes such as (but not limited to): D5 glycerol, U-13C6 potassium palmitate, U13C beta hydroxybutyrate, 6,6-D2-D 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-D 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 by the Contractor.

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:

• 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 at the time of award, but most shipments will be to the main NIH campus in Bethesda, Maryland.

SPECIAL INSTRUCTIONS:

If your firm/business has an interest and possess the required expertise, the Government invites you to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The associated NAICS code is 325412, with the size standard of 1300 employees.

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

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

All respondents are requested to identify their firm’s size and type of business.

Interested firms responding to this Small Business Sources Sought Notice should adhere to the following:

(a) Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities. The capability statement should not exceed 10 pages using a font size 10 or larger.

(b) Small business concerns that possess the capabilities necessary to undertake the efforts should submit complete documentation of their capabilities to the Contracting Officer. This capability statement should include: 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as they relate to the requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) any other specific and relevant information that would improve the Government's consideration and evaluation of the information presented.

Additionally, small business concerns should submit approval by NIH Office of Research Support and Compliance (ORSC) to provide metabolic isotopes to NIH.

Further, Past Performance documentation, which should include, but not be limited to, a minimum of two (2) contracts performed for either Government or commercial organizations shall be provided. References shall include for each contract: names, titles, contract number, total price or cost, telephone numbers of Government COR and Contracting Officers (COs).

(c) All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Point of Contact below in MS Word or Adobe Portable Document Format (PDF). The subject line must specify notice 75N94024Q00094.

Facsimile responses will not be accepted. Electronically submitted capability statements are due no later than 9:00AM (Eastern Prevailing Time) on May 13, 2024.

CAPABILITY STATEMENTS RECEIVED AFTER MAY 13, 2024 @ 9:00 AM EST

WILL NOT BE CONSIDERED

This notice is for information and planning purposes only and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited.

This announcement is Government market research and may result in revisions in both its requirements and its acquisition strategy based on industry responses.

It is emphasized that this is a notice for planning and information purposes only and is not to be construed as a commitment by the Government to enter into a contractual agreement, nor will the Government pay for information solicited.

No phone calls will be accepted. Responses to this Small Business Sources Sought Notice shall be submitted before the closing date and time to the attention of the Contract Specialist and Contracting Officer listed below.

Primary Point of Contact:

Trish Matthews Contract Specialist trish.matthews@nih.gov

Secondary Point of Contact:

Kimesha Leake Contracting Officer kimesha.leake@nih.gov

Contracting Office Address:

Eunice Kennedy Shriver National Institute of Child Health and Human Development 6710-B Rockledge Drive.

Bethesda, Maryland 20892 mailto:alice.pagan@nih.gov mailto:mahaset@mail.nih.gov