75N94024Q00266.Combined Synopsis Solicitation.pdf

COMBINED SYNOPSIS / SOLICITATION WORKFORM

(1) Action Code: Combined Synopsis/Solicitation

(2) Date: 9/5/2024

(3) Year: 2024

(4) Contracting Office Zip Code: 20892

(5) Project Service Code: 6515 - MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND

SUPPLIES

(6) Contracting Office Address:

6710B Rockledge Drive Bethesda, MD 20892

(7) Subject/Title: Acquisition of a U-Rhythm Device for Endocrine and Metabolic Investigation

(8) Proposed Solicitation Number: 75N94024Q00266

(9) Closing Response Date: 9/12/2024

(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 75N94024Q00266 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 FAC 2024-05 Effective May 22, 2024.

(iv) The associated NAICS code is 334516, Analytical Laboratory Instrument Manufacturing, and the small business size standard is 1,000. 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 a U-Rhythm Device for Endocrine and Metabolic Investigation

2.0 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.

Dr. Nieman, a Senior Investigator in NIDDK, NIH, needs to purchase U-RHYTHM microdialysis collection devices to carry out a protocol that requires collection of interstitial tissue fluid to measure hormone levels in the fluid.

The recently developed U-RHYTHM system is a novel way to interrogate tissue exposure of people to cortisol or other hormones/substances over a 24-hour period (or longer) in a real-world ambulatory setting. It couples a portable, battery-operated syringe pump to a subcutaneous microdialysis catheter with 20kD pores that is connected to an automated, body-worn fraction collector, permitting collection and separation of high time resolution samples obtained in an outpatient setting.

3.0 OBJECTIVE

The objective is to purchase U-RHYTHM microdialysis collection devices.

4.0 SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

The bench-to-bedside project “Development of the U-Rhythm device for endocrine and metabolic investigation” centers around evaluation of hormone levels in fluid that surrounds cells within tissues. In blood, some hormones are normally bound, in part, to a “chaperone” protein. This “bound” fraction is not biologically active because it is too big to cross out of the blood into the tissues. However, the unbound or “free” fraction is biologically active, crosses into tissues and causes hormonal effects. Until now it has not been possible to measure these levels easily. However, with the development of the U- RHYTHM device, it is now possible to collect this fluid by pumping a special fluid through a microdialysis tube inserted in the fat under the skin. The free hormone then enters the catheter and the hormone-containing fluid is pumped past the catheter, spooled and stored in a collection device (the U-RHYTHM device).

The following product features/characteristics are required for this requirement:

A portable, battery-operated syringe pump that can be coupled to a subcutaneous microdialysis catheter with 20kD pores that can be attached to an automated, body-worn fraction collector.

• U-RHYTHM 4.0 microdialysis collection device Qty 3

• Adapter line set (4 Tubing Assemblies per unit) Qty 20

• Spool cartons consumable (25pcs). 1 QTY Hex Tool. Qty 4

• 1 x U-RHYTHM cleaning set Qty 3

• 1 x Spool Processing Kit Qty 3

• International delivery costs Qty 4

• Pump bayyery Qty 16

• Delivery insurance (1% of goods value)

Task Areas:

Task Area 1 – Training Training should occur virtually within 3 weeks of delivery, for up to 5 users.

5.0 PURCHASE ORDER TYPE

This Purchase Order is to be a Firm-Fixed Price.

6.0 PERIOD OF PERFORMANCE AND PAYMENT BREAKDOWN

Payment shall be made in one lump sum. Payment terms per the vendor allowance.

7.0 INSPECTION AND ACCEPTANCE

The Project Officer or the Project Officer Supervisor will perform inspection and acceptance of materials and services to be provided. For equipment orders, inspection and acceptance will be done AFTER All materials are unpacked, installed, and test run for operation. Receiving will be completed no later than 7 days following date of Delivery.

Acceptance and Delivery will be complete once the signed packing slip is provided to the Vendor.

Inspection and acceptance will be performed at the place of installation –

The National Institutes of Health, NIDDK, Bldg. 10, 9000 Rockville Pike, Bethesda, Maryland 20892.

For services, invoices will be approved by the Project officer and or COR according to payment terms in the resultant purchase order.

(vi) This is a competitive requirement being pursued through the authority granted in FAR 52.211-6, Brand Name or Equal. This is a requirement for a Dynamic Therapeutics U- RHYTHM 4.0 microdialysis collection device.

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

(viii) 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 vendor will be evaluated on their quoted product meeting the specifications under section 4.0 SALIENT / REQUIRED FEATURES AND SPECIFICATIONS.

ii. The Offeror should note that the evaluation criteria listed in order of importance are:

A. Technical – The services proposed by the vendor meets the requirements in the SOW

B. Cost/Price

The specific technical factors are as follows:

A portable, battery-operated syringe pump that can be coupled to a subcutaneous microdialysis catheter with 20kD pores that can be attached to an automated, body-worn fraction collector.

• U-RHYTHM 4.0 microdialysis collection device Qty 3

• Adapter line set (4 Tubing Assemblies per unit) Qty 20

• Spool cartons consumable (25pcs). 1 QTY Hex Tool. Qty 4

• 1 x U-RHYTHM cleaning set Qty 3

• 1 x Spool Processing Kit Qty 3

• International delivery costs Qty 4

• Pump bayyery Qty 16

• Delivery insurance (1% of goods value)

The evaluation will be based on the demonstrated capabilities of the prospective Offeror in relation to the needs of the project as set forth in the Statement of Work. The merits of the proposal will be evaluated carefully and will be deemed Acceptable or Unacceptable. The proposal must document the feasibility of successful implementation of the requirements of the Statement of Work. The Offeror must submit information sufficient to evaluate the proposal based on the detailed factors listed in section 4.0 SALIENT / REQUIRED FEATURES AND

SPECIFICATIONS.

Evaluation Criteria Acceptable Unacceptable

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

Summary Overall Rating (Overall Risk)

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

Technical Evaluation Rating Definitions

(ix) 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.

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

(xi) 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. 52.203-6, Restrictions on Subcontractor Sales to the Government

ii. 52.203-13, Contractor Code of Business Ethics and Conduct

iii. 52.204-10, Reporting Executive Compensation and First-Tier

Subcontract Awards

iv. 52.204-27, Prohibition on a ByteDance Covered Application

v. 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

vi. 52.209-9, Updates of Publicly Available Information Regarding

Responsibility

vii. Matters

viii. FAR 52.211-6, Brand Name or Equal

ix. 52.219-4, Notice of Price Evaluation Preference for HUBZone Small

Business Concerns

x. 52.219-8, Utilization of Small Business Concerns

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

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

xiii. 52.222-21, Prohibition of Segregated Facilities

xiv. 52.222-26, Equal Opportunity

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

xvi. 52.222-50 Combating Trafficking in Persons

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

xviii. 52.225-1, Buy American- Supplies

xix. 52.225-13, Restrictions on Certain Foreign Purchases

Additional Clauses:

i. 52.232-29, Terms for Financing of Purchases of Commercial Items

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/

ii. 52.232-33, Payment by Electronic Funds Transfer— System for Award Management

iii. 52.232-39, Unenforceability of Unauthorized Obligations

(xii) Additional Contract Requirements:

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)

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

(xiv) Offers shall be submitted via email to amber.harris@nih.gov and must reference 75N94024Q00266 in the subject line.

(17) Place of Contract Performance:

National Institute of Health, NIDDK 10 Center Drive Bethesda MD 20892

(18) Set-aside Status: This requirement is not set aside for small business.

mailto:amber.harris@nih.gov