Amendment 0007_IsolationGowns111722.pdf

******Amendment 0007- Isolation Gowns******

Amendment 0007 incorporates the following changes to Amendment 0005, Solicitation No. 75A50322R00008 for Isolation Gowns.

1. Section B, line items 2001, 2002, and 2003, and notations B.2, B.2.1, B.5, B.5.A are updated to read as follows:

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Contract Line Items

Optional Quantity

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT PRICE

Optional Ordering

Quantity Isolation Gowns

Level 2 Size:

Large

The required Isolation Gowns are to be provided in accordance with the Statement of Work (SOW) below, Terms and Conditions contained herein, and the Contractor’s proposal dated 2022.

This is an option for increased quantity.

This is an option for additional quantity and may be exercised more than once; see B.2 below.

This is a Firm Fixed Price line item.

Anticipated Ordering Period: 31 December

2024 through 30 December 2025

75,200,000 Each $

Optional Ordering Quantity

Isolation Gowns Level 2 Size:

X-Large

The required Isolation Gowns are to be provided in accordance with the Statement of Work (SOW) below, Terms and Conditions contained herein, and the Contractor’s proposal dated

This is an option for increased quantity.

This is an option for additional quantity and may be exercised more than once.

See B.2 below.

This is a Firm Fixed Price line item.

Anticipated Ordering Period: 31 December 2024 through 30 December 2025

75,200,000 Each $

2003 Surge Line OPTION – Surge Capacity (Emergency/Pandemic) for Isolation Gowns (associated with CLIN 2001 and 2002)

If the Government determines that there is a need for this Option during this performance period and has the funding, the Government will exercise this option by providing written notification to the Contractor as outlined below and in accordance with Optional Surge Capacity as described in B.2.1.

Surge costs are estimated for award purposes only in an amount not to exceed 20% of CLIN 2001 and 2002 above.

This is a Firm Fixed Price line item.

Period of Performance will not exceed the period of performance for CLIN 2001 and 2002.

To Be Included as an Unfunded CLIN at Time of Award

B.2 Option for Increased Quantity- Separately priced line items 2001 and 2002.

B.2.1 OPTIONAL Surge Capacity – Included as Separately Priced Line Item 2003:

Base and Optional Surge Periods

Optional Surge capacity is an option requiring the Contractor to provide surge capacity for an emergency or pandemic if the Government has such a requirement. The surge-related requirements may result in increased volume for any of the remaining CLINs listed in the SOW.

Due to the nature of ASPR’s mandate to provide a public health response to both public health events and emergency conditions and situations, there may be times that surge capacity will be required to meet these demands.

Surge periods may be exercised at any time during the period of performance to provide continuous support of the activities outlined in the SOW, as needed, work will require accelerated or increased quantities to address the specific needs identified at that time and will be negotiated between the vendor and the government.

Surge Capacity may be required due to developments impacting the need for support capacity including urgent congressional inquiries/directives and associated impact on application requirements or performance, reorganization, the end of the Fiscal Year, pandemic outbreaks affecting the health and welfare of mothers or children, other public health events to include attacks, natural disasters, outbreaks, epidemics, or similar events that increase the required level of effort, urgency or time pressure to getting the ASPR mission accomplished.

The Contractor must be capable of responding to unanticipated demands for increased capacity within existing capabilities covered under this SOW that may require a “surge” in efforts and/or resources. Surge requirements are demands primarily for accelerated or increased quantity, within existing activities identified in this SOW, including ‘emergency response’ related activities, public health events, Congressional inquiries/directives, or similar.

If accelerated or increased quantities are required, the Government will determine the estimated need that is required. In some instances, an abbreviated technical or business proposal may be requested by the Government.

This step will usually occur before a surge line item is exercised. In an urgent situation, this step may occur after the surge option is exercised.

The CLINs associated with surge may be exercised multiple times up to 20% of CLIN pricing stated in the Schedule B for each performance period. At least five (5) days before the surge option is exercised, the Contracting Officer will provide preliminary written notification to the Contractor. After that written notification, a funded, unilateral modification will be issued to exercise the option or options. The Contracting Officer may choose to issue a bilateral modification. If the preliminary written notification to the Contractor is sent less than five (5) days before the surge option is exercised, then a bilateral modification must be issued to exercise the option or options. If the surge option for the Base Period is exercised at time of award and funded for the full amount of the price for that line item, no preliminary written notification is required.

The exact period of performance for this option will be established at the time it is exercised and is intended to occur within the time period of the associated period of performance.

The Government reserves the right to exercise this Option to meet surge requirements in whole or in part. The Government reserves the right not to exercise the Option of the surge, if no surge requirements are required during the entire performance of this contract.

(End of Clause)

B.5 Delivery Schedule Milestones- Offerors shall provide the following information

B.5.A.Offerors shall provide the following information:

B.5.A - Below is a delivery schedule template for CLINs 1001 & 1002. Offerors shall update this with their proposed delivery schedule and quantities. It is anticipated that SNS warehouses cannot receive more than 10 Million isolation gowns per month cumulative from all vendors. Accordingly, monthly quantities for the Base Period shall not exceed 10 million per month.

Delivery Period 31 December 2022 – 30 December 2023 (Base)

CLIN Product

Type

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sept

Oct

Nov

Annual Total

1001 18.8M

1002 18.8M

Delivery Period 31 December 2023 – 30 December 2024 (Base)

CLIN Product

Type

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sept

Oct

Nov

Annual Total

1001 18.8M

1002 18.8M

TOTAL POTENTIAL AGGREGATE VALUE of LINE ITEMS 1001 through 2002 (Contract Value):

2. Section C, items C.4, C.5, and the description for Quality Control Plan Report are updated to read as follows:

SECTION C - STATEMENT WORK STATEMENT (SOW)

C.4 Shelf-Life

If the Offeror is making a shelf-life claim (a statement in the proposal, on the technical specification sheet, an expiration date listed on the isolation gown packaging, etc.) then the product, at time of delivery to the SNS, shall have no more than 20% of total shelf-life expended. Offerors shall provide data and documentation, such as accelerated aging and real-time testing reports and other validating documentation, to support their shelf-life claims.

Offerors shall provide a statement verifying that the Isolation Gowns will have no more than 20% of total shelf-life expended upon delivery to the SNS.

If the Offeror is not making a shelf-life claim (no statements made or expiration date listed on the isolation gown packaging, etc.), the product, at the time of delivery to the SNS, shall have no more than 3 months expended since the date of manufacture, as listed on the gown packaging. Offerors shall provide a statement verifying that the Isolation Gowns will have no more than 3 months expended since the date of manufacture.

C.5 Deliverables

Deliverable Format/Deliver to Date Delivery Documents Scan and email to COR/POC 2 Business days prior to delivery.

Packing Slips Scan and email to COR/POC 48 hours after delivery Monthly Report E-mail to COR/POC Within 2 business days from the beginning of each month Delivery Schedules E-mail to COR/POC 5 Business days prior to the beginning of each month Biocompatibility Reports E-mail to COR/POC Within 45 days of award or prior to first delivery, whichever comes first Final Report E-mail to COR/POC Within 5 business days from end of contract.

Quality Control Plan(QCP)

E-mail to COR/POC Within 5 business days from the date of award

Quality Control Plan Report- The Quality Control Plan must address the appropriate controls (e.g., process controls, lot release testing) implemented within the Quality System as, for example, seam strength and integrity may vary across different lots and lot measure release testing may help ensure product quality and consistency to meet specifications.

3. Section I- Contract Clauses is updated to incorporate FAR Clause 52.217-9- Option to Extend the Term of the Contract in full text, and to correct omnibus FAR Clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Products and Commercial Services by unchecking the line beside item (15) (i) clause i52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).:

Section I - Contract Clauses

OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days;

provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed four years .

(End of clause)

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Products and Commercial Services (Oct 2022)

(15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3

4. Section L - Changes the file size limitation to 10MB and revised or update the language in L.4 Technical Proposal Content/Instruction.

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO BIDDERS

L.1 ADDENDUM TO FAR 52.212-1- INSTRUCTIONS TO OFFERORS-

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

Complete proposals must be e-mailed directly to dsnssolications@cdc.gov and received by no later than November 17, 2022, at 1:00pm ET. Please note that there may be delays in receiving these electronic submissions through USG email server system. Please allow for potential delay and we encourage you to send at least an hour before the deadline.

Furthermore, the file has 10MB file size limitations on email servers. Please be prepared to adjust accordingly. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

L.4 – TECHNICAL PROPOSAL CONTENT/INSTRUCTION

Factor 1: Technical Compliance Domestic End Product Criteria (MANDATORY REQUIREMENT)

Offerors shall provide documentation supporting their claim that the offered product is a domestic end product.

The offeror shall demonstrate that they can meet Domestic End Product requirement identified in (Section H.5) Product Technical Requirements. This is a mandatory requirement. The offeror proposal must demonstrate that the proposed Isolation Gowns are compliant with the IIJA/Make PPE in America Act. The goods must be manufactured in the U.S. or its territories, which means items for personal protective equipment, including the materials and components thereof, that are grown, reprocessed, reused, or produced in the United States.

“Component” means an article, material, or supply incorporated directly into an end product. A “domestic component” means one that is manufactured/sourced in the United States, its territories, or tribal locations.

The U.S. and its territories include;

(1) The fifty States;

(2) The District of Columbia;

(3) The commonwealths of Puerto Rico and the Northern Mariana Islands;

(4) The territories of American Samoa, Guam, and the United States Virgin Islands; and

(5) The minor outlying islands of Baker Island, Howland Island, Jarvis Island, Johnston Atoll, Kingman Reef, Midway Islands, Navassa Island, Palmyra Atoll, and Wake Atoll

Factor 2- Technical Capability-Subfactor 6- Shelf-life:

If the Offeror is making a shelf-life claim (a statement in the proposal, on the technical specification sheet, an expiration date listed on the isolation gown packaging, etc.) then the product, when delivered to the SNS, shall have no more than 20% of total shelf-life expended. Offerors shall provide data and documentation such as accelerated aging and real-time testing reports and other validating documentation, to support their shelf-life claims. Offerors shall provide a statement verifying that the Isolation Gowns will have no more than 20% of total shelf-life expended at time of delivery to the SNS.

If the Offeror is not making a shelf-life claim (no statements made or expiration date listed on the isolation gown packaging, etc), the product, at time of delivery to the SNS, shall have no more than 3 months expended since the mailto:dsnssolications@cdc.gov date of manufacture, as listed on the gown packaging. Offerors shall provide a statement verifying that at time of delivery to the SNS, the Isolation Gowns will have no more than 3 months expended since the date of manufacture.

Factor 2: Technical Capability- Subfactor 8

Offerors shall provide test reports and results passing and aligning in accordance with ISO 10993-5 (cytotoxicity), 10993-10 (irritation and sensitization), and 10993-1. If biocompatibility testing is performed on other than the full finished Isolation Gown, this shall be disclosed, and appropriate justifications and statements shall be provided in accordance with ISO 10993-1, ISO 10993-5, and ISO 10993-10.

Offerors shall provide biocompatibility testing (ISO 10993-5 for cytotoxicity and ISO 10993-10 for irritation and sensitization) performed at an independent ISO 17025 accredited laboratory and provide documentation verifying the laboratory’s ISO 17025 accreditation and that each test performed at the laboratory is within the scope of accreditation. Biocompatibility test reports and laboratory accreditation and scope documentation shall be in English. Offerors shall provide a plan to obtain and deliver biocompatibility test reports (ISO 10993-5 for cytotoxicity and ISO 10993-10 for irritation and sensitization) on the Isolation Gown from an independent ISO 17025 accredited laboratory to the COR/POC for review, within 45 days of award. This shall include a timeline with dates and the accredited laboratory’s information (name, address, etc.)

If the Offeror already has these biocompatibility reports completed, the Offeror is only required to indicate the date the report was completed and the accredited laboratory’s information (name, address, et) with the initial proposal.

Biocompatibility test reports and laboratory accreditation and testing scope documentation shall be provided within 45 days of award.

5. Section M- Revisions are made to Section M- Evaluation Factors for Award- Factor 2- Technical Capability- Subfactor 6- Shelf-life and Subfactor 8- Biocompatibility Report Plan:

Section M- Evaluation Factors for Award

Factor 2- Technical Capability-Subfactor 6- Shelf-life:

If the Offeror is making a shelf-life claim (a statement in the proposal, on the technical specification sheet, an expiration date listed on the isolation gown packaging, etc.) then the product, when delivered to the SNS, shall have no more than 20% of total shelf-life expended. Offerors will be evaluated based on providing the appropriate data and documentation, such as accelerated aging and real-time testing reports and other validating documentation, to support their shelf-life claims.

Offerors will be evaluated based on providing a statement verifying that the Isolation Gowns will have no more than 20% of total shelf-life expended upon delivery to the SNS. If the Offeror is not making a shelf-life claim (no statements made or expiration date listed on the isolation gown packaging), the product, when delivered to the SNS, shall have no more than 3 months expended since the date of manufacture, as listed on the gown packaging. Offerors will be evaluated based on no shelf-life claims being made and a statement provided verifying that at time of delivery to the SNS the Isolation Gowns will have no more than 3 months expended since the date of manufacture.

Factor 2- Technical Capability- Subfactor 8- Biocompatibility Report Plan

Offerors will be evaluated on their test reports and results passing and aligning in accordance with ISO 10993-5 (cytotoxicity), 10993-10 (irritation and sensitization), and 10993-1. If biocompatibility testing is performed on other than the full finished Isolation Gown, this shall be disclosed and appropriate justifications and statements shall be provided in accordance with ISO 10993-1, ISO 10993-5, and ISO 10993-10. Biocompatibility test reports and laboratory accreditation and scope documentation shall be in English.

Offerors’ proposals will be evaluated based on biocompatibility testing (ISO 10993-5 for cytotoxicity and ISO 10993-10 for irritation and sensitization) being performed at an independent ISO 17025 laboratory and verifying documentation provided supporting the laboratory’s ISO 17025 accreditation and illustrating that each test performed at the laboratory is within the scope of accreditation.

Biocompatibility test reports and laboratory accreditation and scope documentation shall be in English.

Offeror’s proposals will be evaluated based on their ability to provide a biocompatibility test plan (to include a timeline with dates and the ISO 17025 accredited independent laboratory’s information such as name, address, etc) to the COR/POC within 45 days from contract award, and the biocompatibility test reports on the Isolation Gown from an ISO 17025 accredited independent laboratory within 45 days of award or prior to the first delivery (whichever comes first) inclusive of a timeline.

Notice of Intent to Award without Discussions: It is the intention of the Government to evaluate proposals and award a contract without conducting discussions with Contractors.

***********End of Amendment 0007************