Sol_75N92024Q1031.pdf

75N92024Q1031

1. REQUEST NO.

5a. ISSUED BY

NAME

a. NAME

c. STREET ADDRESS

d. CITY

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON

OR BEFORE CLOSE OF BUSINESS (Date)

2. DATE ISSUED 3. REQUISITION/PURCHASE REQUEST NO. 4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG.1

RATING

6. DELIVERY BY (Date)

7. DELIVERY

9. DESTINATION

a. NAME OF CONSIGNEE

b. STREET ADDRESS

PAGE OF PAGES

5b. FOR INFORMATION CALL: (No collect calls)

TELEPHONE NUMBER

AREA CODE NUMBER

8. TO:

b. COMPANY

e. STATE f. ZIP CODE

c. CITY

d. STATE e. ZIP CODE

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5a. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

THIS RFQ

REQUEST FOR QUOTATION

(THIS IS NOT AN ORDER)

IS IS NOT A SMALL BUSINESS SET ASIDEX

07/12/2024

1 6

National Heart, Lung, and Blood Institutes Bethesda MD 20892-7511

National Institutes of Health Multiple

Jimmy Sanders

30 Convent Drive Bldg 30, Bethesda Main Campus

Bethesda

MD 20814

James Hawkins

07/19/2024 1600 ED

FOB DESTINATION

OTHER

(See Schedule)X

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

See Request for Quote.

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS (%) b. 20 CALENDAR DAYS (%) c. 30 CALENDAR DAYS (%) d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations

13. NAME AND ADDRESS OF QUOTER

b. STREET ADDRESS

c. COUNTY

d. CITY e. STATE f. ZIP CODE

14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

16. SIGNER

a. NAME (Type or print)

c. TITLE (Type or print)

a. NAME OF QUOTER

AREA CODE

NUMBER

15. DATE OF QUOTATION

b. TELEPHONE are are not attached

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition not usable

STANDARD FORM 18 (REV. 6-95)

Prescribed by GSA - FAR (48 CFR) 53.215-1(a)

COMBINED SYNOPSIS / SOLICITATION

WORKFORM

(1) Action Code: Combined Synopsis/Solicitation

(2) Date: 07/12/2024

(3) Year: 2024

(4) Contracting Office Zip Code: 20892

(5) Classification Code: Q301

(6) Contracting Office Address:

6705 Rockledge Drive

RKL I

Bethesda, MD 20892

(7) Subject/Title: DiGeorge Syndrome (DGS) Patient Derived induced pluripotent stem cells (iPSCs)

(8) Proposed Solicitation Number: 75N92024Q1031

(9) Closing Response Date: 07/19/2024

(10) Contact Point(s): James Hawkins, Contract Specialist

(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:

(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; proposals are being requested and a separate written solicitation will not be issued.

(ii) The solicitation number is 75N92024Q1031 and the solicitation is issued as a request for quotation (RFQ).

(iii) The solicitation document, the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-05 effective 05/22/2024.

(iv) This requirement has no set-aside restrictions. The associated NAICS code is 541990 – All Other Professional, Scientific, and Technical Services, Small Business Size $17M. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13.

(v) It is anticipated that there will be one (1) or more contract line items listing all components. The specifications and quantities of required items are listed below.

(vi) The requested requirements are listed below in the Statement of Work.

(vii) Statement of Work

Background

The purpose of the acquisition is to provide the Neural Crest Development and Disease Unit in the NIDCR, DiGeorge Syndrome (DGS) Patient Derived induced pluripotent stem cells (iPSCs).

DGS is a human disorder characterized by a deletions of the 22q11.2 region. DGS is a common disorder with the incident rate for DGS to be as high as 1:3000 live births. DGS phenotypically presents as individuals with craniofacial defects, heart valve defects, and neurodevelopmental defects. These are phenotypes that can be commonly characterized as neurocristopathies, diseases of the neural crest. The neural crest is a pluripotent cell type that develop during very early development to generate many cell types in the body. Interestingly, not many have described or studied DGS as a neurocristopathy. The etiology of DGS and how it affects neural crest development needs to be further elucidated.

The iPSCs generated from this project will be used in a differentiation protocol to generate neural crest cells (NCCs) and their derivatives to elucidate the effects of the DGS deletion mutation on the NCCs and their derivatives. This project will provide important reagents for studying the etiology of DGS and can help with the discovery of novel treatments for DGS.

Contractor Requirements

The contractor shall provide the Generation of polyclonal iPSCs (6 vial(s)/line).

The contractor shall provide 3 patient derived iPSC lines with isogenic controls.

1) NIGMS Human Genetic Cell Repository Starting Materials.

a. Starting Materials Description

The following patient fibroblast samples obtained by the contractor from the NIGMS Human Genetic Cell Repository shall be used in connection with this statement of work:

GM05876

GM07215

GM13325

2) Generation & Quality Control Specifications of Deliverables.

a. Contractor’s iPSC Generation Workflow shall consist of Donor samples, Sample Isolation, Banking of starting material, Reprogramming, Generation of Isogenic Controls, Monoclonalization, working bank, banking freeze-thaw, Characterization, Quality Control (QC), and Genotyping (Karyotype and Identity) of iPSCs.

b. Quality Control of Deliverables The table below lists the QC tests that will be performed on iPSCs delivered to NIDCR.

The contractor will provide a Certificate of Analysis (COA) for each line generated. The contractor will test each line at appropriate passages after initial derivation.

Test Description

Test Method Test Specification Result

Post-Thaw Viable Cell Recovery

Contractor preferred method

>50% Confluency reached within 10 days

Pass

Sterility from microbiota and fungi

Contractor preferred method

Negative Pass

Mycoplasma Contractor preferred method

Negative Pass

Karyotype Contractor preferred method

Normal Karyotype Pass

Identity Test Contractor preferred method

Match parent line Pass

Pluripotency Expression Profile

Contractor preferred method

Express markers of pluripotency with absence of early differentiation markers

Pass

Differentiation Capacity

Contractor preferred method

Absence of bias to differentiation into any of three germ layers

Pass

Deliverables

Timeline for Generation and Delivery of Deliverables.

From each of the provided patient fibroblast samples, the contractor shall create a polyclonal line. The contractor will deliver the resulting iPSCs to NIDCR approximately six to nine months (6-9 months) from the date of receipt of the Starting Materials.

The contractor shall provide to NIDCR six (6) vials of iPSCs from each originating sample. Each vial will contain approximately five hundred thousand cells (~5x10^5 cells/vial). NIDCR may request that the contractor provide additional vials and/or multiple polyclonal lines from each originating sample for additional fees.

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

• The Government requests discounts

• Less than the total quantity of either items may be awarded

• Quotes must include itemized prices

• The Government intends to evaluate offers and award a contract without discussions with offerors

(ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Items, is applicable to this acquisition.

• The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous and best value to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

o Offeror can provide all required services/deliverables as described in section (vii) Statement of Work in its entirety.

o Quotes include itemized prices for total cost

(x) Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, with offer. 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) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

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

• 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232)

• 52.204-26 Covered Telecommunications Equipment or Services- Representation (OCT 2020)

• 52.222-3, Convict Labor (JUN 2003) (E.O. 11755)

• 52.222-21, Prohibition of Segregated Facilities (APR 2015)

• 52.222-26, Equal Opportunity (SEP 2016) (E.O. 11246)

• 52.222-36, Equal Opportunity for Workers with Disabilities

(JUN 2020) (29 U.S.C. 793)

• 52.222-50, Combating Trafficking in Persons (NOV

2021). (22 U.S.C. chapter 78 and E.O. 13627)

• 52.222-53, Exemption from Application of the Service Contract

Labor Standards to Contracts for Certain Services- Requirements (MAY 2014) (41 U.S.C. chapter 67)

• 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O.

13513)

• 52.222-55 Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022)

• 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021)

• 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (OCT 2018) (31 U.S.C. 3332)

(xiii) Additional contract requirement(s): N/A

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

(xv) Offers shall be submitted via the FedConnect web portal (www.fedconnect.net). The due date for receipt of offers is 4:00 PM Eastern Time on 07/19/2024.

http://www.acquisition.gov/ http://www.fedconnect.net/

(17) Point of Contact:

James Hawkins, Contract Specialist www.fedconnect.net Solicitation 75N92024Q1031

(18) Place of Performance

Service shall be performed at the contractor’s location

(19) Period of Performance

07/22/2024 – 04/21/2025

(20) Set-aside Status: None http://www.fedconnect.net/