75A50120R00008 solicitation.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

ASPR/SNS

ATLANTA, GA 30341

2945 FLOWERS ROAD

ASPR/SNS

US DEPT OF HEALTH & HUMAN SERVICES

HHS CODE 16. ADMINISTERED BYCODE

X

X

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORASPR/SNS

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

1700 ETANNETTE WRIGHT

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75A50120R00008

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 25OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

ASPR/SNS

2945 FLOWERS ROAD

ATLANTA, GA 30341

15. DELIVER TO

US DEPT OF HEALTH & HUMAN SERVICES

ATLANTA, GA 30341

2945 FLOWERS ROAD

ASPR/SNS

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

ASPR/SNS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

See schedule for details

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

DATED

ANNETTE R. WRIGHT

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

423450

404-498-0949

3/4/2020

75A50120R00008

Section B - Supplies or Services/Prices

Item No.

Description Quantity Unit Unit Price Total Amount

1 N95 Respirators (NIOSH Approved)

This is a Fixed Price line item.

500,000,000 ea. $________ $ ________

Section C -Description/Specifications

C.1 Background

The mission of the Division of Strategic National Stockpile (DSNS), of the United States (U.S.) Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of nerve agents, biological pathogens, and chemical agents. When state, local, tribal, and territorial public health and medical systems request federal assistance to support their response efforts, DSNS ensures that the right medicines and supplies get to those who need them most during an emergency.

The Strategic National Stockpile (SNS) is a national repository of large quantities of medicines, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. These assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that causes local supplies to run out.

Protection of healthcare workers and first responders from respiratory transmission of pathogens is essential to maintaining resilience of the U.S. healthcare system. NIOSH approved N95 Respirators are one part of an infection control strategy and are examples of personal protective equipment (PPE) that are used to protect the wearer from liquid and airborne particles. The appropriate use of PPE is an important component of the overall strategy of certain infection prevention controls.

C.2 Purpose

The U.S. Government is interested in establishing multiple awards for immediate purchases of National Institute for Occupational Safety and Health (NIOSH) approved N95 Respirators used in healthcare settings as described below. In establishing orders for such, the Government is attempting to increase the availability of domestically produced Trade Agreements Act (TAA) compliant PPE. This will enable the United States to ensure sufficient availability of such items during national emergencies and/or pandemic events. The Government is concerned about the risks of disruption of any manufacturing facilities or supply chains located outside of the United States. Thus offerors are advised to pay special attention to the instructions regarding manufacturing capability and/or supply chains located outside of the United States as well as the evaluation criteria related to manufacturing capability and foreign supply chains. The Government is concerned about the risks related to excessive pricing of critical PPE and intends only to acquire PPE at prices that it can determine are fair and reasonable. Thus, offerors are advised to pay special attention to the instructions regarding pricing.

The following is a summary to provide clarification about the different types of acceptable N95 Respirators for facial protection that may be proposed as part of the requirement:

a. N95 Filtering Facepiece Respirator (FFR): Single-use, disposable half-mask NIOSH-approved RPDs that covers the user’s airway (nose and mouth) and offers protection from particulate materials at an N95 filtration efficiency level. N95 FFRs are approved by NIOSH under 42 CFR Part 84 and are referred to as N95 Respirators in this document.

b. N95 Respirators used in healthcare settings: Includes N95 FFR approved by NIOSH with additional protections as described in the FDA/NIOSH MOU established in 2018. Such an N95 FFR used in a healthcare setting is a class II device and is also regulated by FDA under 21 CFR 878.4040 (FDA product code MSH).

c. Surgical N95 Respirators: Single-use, disposable NIOSH-approved and FDA-cleared RPD used in a healthcare setting that is worn by HCP during procedures to protect both the patient and HCP from the transfer of microorganisms, body fluids, and particulate material at an N95 filtration efficiency level.

https://www.fda.gov/about-fda/domestic-mous/mou-225-18-006

C.3. Scope of Work

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all labor, materials, supplies, facilities, equipment, transportation and travel necessary to deliver one or more of the following acceptable N95 Respirators:

• NIOSH-approved N95 Filtering Facepiece Respirators

• NIOSH-approved and FDA-cleared Surgical N95 Respirators

• NIOSH-approved N95 Filtering Facepiece Respirators used in healthcare items.

Any combination of the NIOSH approved N95 Respirators is acceptable to meet the Government ‘s requirement.

C.4 Contract Period of Performance

The Government has a requirement to acquire these items for both response to public health events, and preparedness. Due to the COVID-19 response ongoing at the time of solicitation of this requirement, the Government has a need for some of the items to be delivered quickly; offerors are to provide a proposed schedule for items that can be delivered quickly without overwhelming the supply chain, with additional items delivered over a period not to exceed 18 months. In an effort to not disrupt the current supply chain during a national emergency, the Government is anticipating a split award resulting in multiple contracts for incremental delivery of items over a period not to exceed 18 months. Proposed delivery schedules will be finalized and become part of the award.

C.5 Delivery Location & Shipping Requirements:

The address(es) will be provided at time of award and will be to a Government facility within the Continental United States.

• All shipments will include packing slips and contract number.

• Storage Requirements shall be on all packing lists.

• No Partial Case or Packages quantities will be accepted unless approved by SNS in advance.

• No Mixed Lot #'s per Case or per Packages will be accepted unless approved by SNS in advance.

• Item description, NDC/Part number, Lot numbers and quantities shall be included on the packing list.

• All pallets are to have the identical TyHi stack pattern except for the final pallet.

• All product to be delivered on standard 48" by 40" pallet, not to exceed 60” in height, stretch wrapped and secured to pallet for safe transport.

• Full case quantities only unless approved by SNS in advance.

• Contractor shall contact the designated point of contact (POC) to schedule delivery appointments.

C.6 Deliverables

Deliverable Format/Deliver to Date Kick-Off Meeting Notes Should contain a detailed overview of the discussion.

Electronic copy of Kick-Off Meeting Notes – COR

Within 5 days of meeting being held

Delivery Documents Scan and email to COR/POC 5 Business Days Prior to Delivery Packing Slips Scan and email to COR/POC 48 hours after delivery Quarterly Report Summary of delivered product during that quarter and future product deliveries.

Within 5 business days after the end of every 3-month period.

Final Report Summary of all deliveries under performance of this contract.

Within 5 business days from final delivery or end of contract, whichever comes first.

Section D- Packaging and Marking

D.1 Payment of Postage Fees. All postage and fees related to submission of information, including forms, and reports, etc., to the Contracting Officer or Contracting Officer’s Representative (COR) or other persons designated to receive, shall be paid by the Contractor.

D.2 Markings. All deliveries submitted to the CO or the COR or other DSNS personnel designated to receive deliverables shall clearly indicate the following information:

(1) Agency/Requiring LOC Service Unit and MAIL STOP/Room Number

(2) Description of information/data being submitted

(3) Contract Number

(4) Contractor Name and Address

Section E- Inspection and Acceptance

E.1 Inspection and acceptance under this contract will be in accordance with FAR 52.212-4 Contract Terms and Conditions - Commercial Items (May 2015).

Section F- Deliveries and Performance

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text.

Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov

(End of Clause)

F.1 Delivery to be determine at time of award

F.2 Delivery Terms: FOB Destination.

FAR SOURCE TITLE AND DATE

52.242-15 Stop-Work Order (Aug 1989)

52.242–17 Government Delay of Work (April 1984)

52.247-34 F.o.b. Destination (Nov 1991) http://www.acquisition.gov/

Section G- Contract Administration Data

G.1 This contract will be administered by the following ASPR/DSNS personnel

Contracting Officer Annette Wright Team Lead Contracting Officer Office of Resource Management (ORM) Assistant Secretary for Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: owf8@cdc.gov| 404-498-0949 office

Contracting Officer Lawrence McCoy Office of Resource Management (ORM) Assistant Secretary for Preparedness and Response (ASPR)

Email: gwg8@cdc.gov| 770-488-2087 office

Senior Contracting Officer Natasha Rowland Office of Resource Management (ORM) Assistant Secretary of Health and Human Services (ASPR)

Email: hee5@cdc.gov |770-488-2601 office

Contracting Officer Representative David Kelley Contracting Officer Representative Division of Strategic National Stockpile (DSNS) Assistant U.S. Department of Health and Human Services (HHS) Email:

Email: vbr7@cdc.gov | 770-488-2662 office

Contract Administrator Akela Long Contracting Officer Office of Resource Management (ORM) Assistant Secretary of Preparedness and Response (ASPR)

Email: oga1@cdc.gov | 404-498-5635 office

G.2 PAYMENT TERMS

INVOICES

(a) Invoice Submission.

(1) The Contractor shall submit invoices once per month.

(2) A proper invoice, with all required back-up documentation shall be sent electronically, via email, to the COR mailbox:

(i) Contracting Officer's Representative(COR): David Kelley; vrb7@cdc.gov

(3) A proper invoice, not including non-invoice related documents (i.e. deliverables, reports, balance statements) shall be sent electronically, via email, to:

(i) Contract Officer via mailbox: Akela Long; oga1@cdc.gov mailto:owf8@cdc.gov mailto:gwg8@cdc.gov mailto:Email:%20hee5@cdc.gov%20%7C mailto:vbr7@cdc.gov mailto:oga1@cdc.gov mailto:vrb7@cdc.gov mailto:%20Akela%20Long%3B%20%20oga1@cdc.gov

(ii) Financial Management Service (FMS) via mailbox:psc_invoices@psc.hhs.gov

(4) The subject line of your email invoice submission shall contain the contract number, order number (if applicable), and the number of invoices. The Contractor shall send one email per contract per month. The email may have multiple invoices for the contract. Invoices must be in the following formats: PDF, TIFF, or Word. No Excel formats will be accepted. The electronic file cannot contain multiple invoices; example, 10 invoices requires 10 separate files (PDF or TIFF or Word).

(5) Invoices shall be submitted in accordance with the contract terms, i.e. payment schedule, progress payments, partial payments, deliverables, etc.

(6) All calls concerning contract payment shall be directed to the COR.

(7) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part1315.

(b) Invoice Elements.

(1) In accordance with FAR 52.212-4, Contract Terms and Conditions-Commercial Items, the Contractor shall submit an electronic invoice to the email addresses designated in the contract to receive invoices. A proper invoice must include the following items:

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, contract line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of persons to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice.

(B) In accordance with the requirements of the Debt Collection Improvement Act of 1996, all payments under this order will be made by electronic funds transfer (EFT). The Contractor shall provide financial institution information to the Finance Office designated above in accordance with FAR 52.232-33 Payment by Electronic Funds Transfer - System for Award Management.

(2) Additionally, the Program Support Center (PSC)requires:

(i) the invoice to break-out price/cost by contract line item number (CLIN) as specified in the pricing section of the contract

(ii) the invoice to include the Dun & Bradstreet Number (DUNS) of the Contractor.

(End Clause) mailto:psc_invoices@psc.hhs.gov

Section H- Special Contract Requirements

H.1 CONTRACTOR PUBLICITY

The Contractor, or any entity or representative acting on behalf of the Contractor, may not refer to the equipment or services furnished pursuant to the provisions of this contract in any news release or commercial advertising, or in connection with any news release or commercial advertising, without first obtaining explicit written consent to do so from the Contracting Officer. Should any reference to such equipment or services appear in any news release or commercial advertising issued by or on behalf of the Contractor without the required consent, the Government will consider institution of all remedies available under applicable law.

H.2 CONTRACTING OFFICER’S REPRESENTATIVE (COR) APPOINTMENT ANDAUTHORITY

Performance of work under this contract is subject to the technical direction of the COR identified in Section G, or a representative designated by the contracting officer in writing. The term “technical direction” includes, without limitation, direction to the con- tractor that directs or redirects the labor effort, shifts the work between work areas or locations, and/or fills in details and otherwise serves to ensure that tasks outlined in the contract are accomplished satisfactorily.

• Technical direction must be within the scope of the contract specification(s)/work statement. The COR does not have authority to issue technical direction that: • Constitutes additional work outside the contract specification(s)/work statement;

• Constitutes a change as defined in the “Changes” clause of this contract;

• Causes an increase or decrease in the contract price, or the time required for contract performance;

• Changes any of the terms, conditions, or specification(s)/work statement of the contract;

• Interferes with the contractor's right to perform under the terms and conditions of the contract; or

• Directs, supervises or otherwise controls the actions of the contractor's employees.

• Technical direction may be oral or in writing. The COR must confirm oral direction in writing within five workdays, with a copy to the Contracting Officer.

• The Contractor shall proceed promptly with performance resulting from the technical direction issued by the COR.

If, in the opinion of the contractor, any direction of the COR or the designated representative falls within the limitations of (c) above, the Contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government workday.

• Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the “Disputes” clause of this contract.

Section I – Contract Clauses

Section I-1 - Clauses Incorporated by Reference

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text.

Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov

(End of Clause)

FAR SOURCE TITLE AND DATE

52.204-13 System for Award Management Maintenance (Oct 2018)

52.204-16 Commercial and Government Entity Code Reporting (Jul 2016)

52.204-17 Ownership or Control of Offeror (Jul 2016)

52.204-20 Predecessor of Offeror (Jul 2016)

52.212-4 Contract Terms and Conditions-Commercial Items (Oct 2018)

HHSAR SOURCE

352.203-70 Anti-Lobbying (Dec 2015)

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

352.227-70 Publications and Publicity (Dec 2015)

353.208-70 Printing and Duplication (Dec 2015)

352.224-70 Privacy Act (Dec 2015)

352.233-71 Litigation and Claims (Dec 2015)

352.237-74 Non-Discrimination in Service Delivery (Dec 2015)

352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

Section I-2 - Clauses Incorporated in Full Text

52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Jan 2019)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

https://www.acquisition.gov/far/html/52_212_213.html#wp1203358

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015). (4) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C.3553).

(5) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C.4704 and 10 U.S.C.2402).

(2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).

(5) [Reserved].

(6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111- 117, section 743 of Div. C).

X (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

(9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C.

2313).

(10) [Reserved].

(11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

(ii) Alternate I (Nov 2011) of 52.219-3.

(12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

(ii) Alternate I (Jan 2011) of 52.219-4.

(13) [Reserved] X (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

(ii) Alternate I (Nov 2011).

(iii) Alternate II (Nov 2011).

(15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

(ii) Alternate I (Oct 1995) of 52.219-7.

(iii) Alternate II (Mar 2004) of 52.219-7.

(16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

(17) (i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637(d)(4))

(ii) Alternate I (Jan 2017) of 52.219-9.

(iii) Alternate II (Nov 2016) of 52.219-9.

(iv) Alternate III (Nov 2016) of 52.219-9.

(v) Alternate IV (Aug 2018) of 52.219-9

(18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

X (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

(20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

X (22) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C. 632(a)(2)).

(23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

(24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec2015) (15 U.S.C. 637(m)). X (25) 52.222-3, Convict Labor (June 2003) (E.O.11755).

X (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2018) (E.O.13126). X (27) 52.222- 21, Prohibition of Segregated Facilities (Apr 2015).

X (28) (i) 52.222-26, Equal Opportunity (Sept 2016) (E.O.11246).

(ii) Alternate I (Feb 1999) of 52.222-26.

X (29) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(ii) Alternate I (July 2014) of 52.222-35.

X (30) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(ii) Alternate I (July 2014) of 52.222-36.

X (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

X (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

(33) (i) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O.

13627).

(ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(34) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

(35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off- the-shelf items.)

(ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

(36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

(37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

(38) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Oct 2015) of 52.223-13.

(39) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-14.

(40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

(41) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-16.

X (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

(43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

(44) 52.223-21, Foams (Jun 2016) (E.O. 13693).

(45) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

(ii) Alternate I (Jan 2017) of 52.224-3.

X (46) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).

(47) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C.

3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L.

103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and

112-43.

(ii) Alternate I (May 2014) of 52.225-3.

(iii) Alternate II (May 2014) of 52.225-3.

(iv) Alternate III (May 2014) of 52.225-3.

(48) 52.225-5, Trade Agreements (Aug 2018) (19 U.S.C.2501, et seq., 19 U.S.C. 3301 note).

X (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

(50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

(52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

(53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C.4505, 10 U.S.C.2307(f)).

(54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).

X (55) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) (31 U.S.C. 3332).

(56) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C.3332).

(57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C.3332).

(58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

(59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(12)).

(60) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx.1241(b) and 10 U.S.C. 2631).

(ii) Alternate I (Apr 2003) of 52.247-64.

(iii) Alternate II (Feb 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

(1) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

(2) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).

(6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

(7) 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).

(8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

(10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph

(d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the dispute’s clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items.

Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C.637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(v) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(vii) 52.222-26, Equal Opportunity (Sept 2015) (E.O.11246).

(viii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(x) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212)

(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(xiii) (A) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O 13627).

(B) Alternate I (Mar 2015) of 52.222-50(22 U.S.C. chapter 78 and E.O 13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

(xv) 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).

(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx.1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

Section J - List of Documents, Exhibits and Other Attachments

Attachment Number Title Date

1 MOU NIOSH/FDA https://www.fda.gov/about-fda/domestic-mous/mou-225-18-006

12/18/2017

Note: MOU is accessible via the link above in lieu of being physically attached to this document.

Section K - Representations, Certifications, And Other Statements Of Offerors

K.1 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

http://www.acquisition.gov

(End of Provision)

FAR SOURCE TITLE AND DATE

52.212-3 Offeror Representations and Certifications – Commercial Items (Oct 2018)

Section L - Instructions, Conditions, and Notices to Bidders

L.1 Submission Instructions

Solicitation Provisions Incorporated by Reference, FAR 52.252-1 (FEB 1998) This Solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address: http://www.acquisition.gov.

(End of Provision)

L.2 FAR 52.216-1 Type of Contract (Apr 1984)

The Government contemplates award of more than one firm fixed price contract resulting from this solicitation.

(End of Provision)

L.3 52.212-1 Instructions to Offerors - Commercial Items (OCT 2018) Offerors must comply with the submission instructions for the format and content of the proposal. If the proposal does not comply with the submission instructions for the format and content, then the Offeror may be ineligible for award.

A. Due Date Proposals are due no later than 18 March 2020 by 5:00 p.m. EST. Email proposal to owf8@cdc.gov and hee5@cdc.gov.

B. Questions Questions related to this solicitation must be submitted in writing to Annette R Wright via email owf8@cdc.gov and Natasha Rowland via email hee5@cdc.gov by 2:00 PM ET, 9 March 2020. Answers to questions of a substantive nature will be provided to all offerors. If the offeror takes exception to a particular task or condition, it must be clearly identified in this section. The ASPR/SNS will not guarantee answers to questions received after this date.

C. Proposal Format Each page is to be numbered and labeled with the name of the offeror, the solicitation number, and a unique proposal number in the header or footer. The format for all typed documents must be 8.5 x 11-inch pages, single- spaced, 1-inch margins, Times New Roman 12-point Font in text. Fonts for graphics can be smaller but must be legible. No hyperlinks.

An accessible version of each proposal section (i.e. readable by screen reader software) shall be submitted electronically in either Adobe PDF or Microsoft Office format.

D. Business Proposal

Business Proposal Instructions

The business proposal shall be comprised of the following elements:

(a) Contract Form and Representation and Certifications

The contract form found in Part I, Section A, the completed Section B, and the Representations and Certifications contained in Part IV, Section K, of this Request for Proposals must be executed by an official authorized to bind the offeror.

http://www.acquisition.gov./ mailto:owf8@cdc.gov mailto:hee5@cdc.gov mailto:hee5@cdc.gov

(b) Contract Proposal Cover Sheet

The cover sheet of your Business Proposal must comply with FAR Table 15-2, which requires the following information (as applicable):

Solicitation, contract, or modification number;

Name and address of offeror;

Name and telephone number of points of contact;

Name, address, and telephone number of Cognizant Contract Administration Office;

Name, address, and telephone number of Cognizant Audit Office;

Proposed cost, profit or fee (as applicable) per year and total for all years.

E. Technical Proposal Content The technical proposal shall be no more than 10 pages in length, excluding resumes and price proposal. Each page is to be numbered and labeled with the name of the offeror in the header or footer. The technical proposal must contain the following sections, in the stated order, numbered and titled to coincide with the numbers and titles below:

1. Production Schedule. Offerors shall provide a detailed delivery schedule and/or production timeline for the quantity proposed over the 18-months Period of performance.

2. Manufacturing Capability. Offeror’s are to provide a detailed overview of their manufacturing capability, output, and ability to meet the Offeror’s proposed quantities. Resellers must provide the same information regarding the capability, output and ability to meet proposed quantities considering the sources of their proposed N95 Respirators and critical components for the respirators. The offerors shall address all items to ensure the adequacy and feasibility of these plans. The plan should identify all proposed manufacturing locations for the end product N95 Respirators, the manufacturing locations of all critical components of the N95 Respirators, and the locations of all raw materials for the N95 Respirators. Risk of disruptions of operations conducted outside of the United States is a critical component of the agency’s evaluation. Therefore the plan should also identify any potential concerns or pitfalls that affect the offerors’ capability to furnish N95 Respirators in the face of potential supply chain disruptions such as raw materials sourced, or manufacturing performed outside of the United States and the potential ramifications a pandemic may have on that supply chain. Offeror’s plans must describe measures that each offeror intends to utilize to overcome disruption of supply chains and or manufacturing facilities located outside the United States.

3. Approval and Clearances. The offeror shall provide sufficient documentation supporting the item(s) proposed are:

1) NIOSH approved,

2) NIOSH approved and FDA cleared,

3) NIOSH approved with protections as described in FDA/NIOSH MOU.

4. Shelf-life. Offerors shall provide the shelf-life of product at time of manufacturing and dictate the shelf-life remaining on what is proposed. For items without a shelf-life, date of manufacture is required. The Government anticipates the delivery of items manufactured within 3 months from date of delivery to ensure the greatest shelf-life. However, the Government will consider product already manufactured and available for immediate delivery with lesser shelf-life if required to meet the total quantity requirement. The Government will consider the cost of the product as it relates to the shelf-life at time of delivery in order to determine best value. In addition, the Government will consider the time, effort, and cost to sustain product with lesser shelf-life.

5. Past -Performance: The Offeror shall provide a description of at least one project performed within the past three years that clearly demonstrates the Offeror’s experience in performing manufacturing projects of similar scope, size and complexity to the requirements described in the statement of work (SOW). The following information shall be provided for each project reference:

a. Contract number, customer/agency name and contract title;

b. Brief narrative description of the work performed for each of those contracts, including a description of how the previous work demonstrates the Offeror’s capacity to successfully meet the requirements described in the request for proposal (RFP) and a discussion of any problems encountered/corrective actions and significant accomplishments;

c. Dollar value, contract type, period of performance, and the quantity and types of product delivered in the performance of the contract;

d. Demonstrated experience in support of an emergency response organization;

e. Demonstrated experience in manufacturing NIOSH approved N95 Filtering Facepiece Respirators AND/OR

NIOSH-approved and FDA-cleared Surgical N95 Respirators AND/OR NIOSH-approved with additional protections as described in the FDA/NIOSH MOU, N95 Filtering Facepiece Respirators.

6. Pricing. Award will be made to offerors proposing prices that the agency can conclude are fair and reasonable. This is a commercial acquisition and offerors will be expected to utilize their established and published commercial market prices for the N95 Respirators as a baseline for any prices offered to the agency in this acquisition. All proposals must reference each offeror’s current established and published commercial market prices. In the event that prices offered to the agency exceed ten percent (10%) of the offeror’s current established and published commercial market prices, the offeror must submit a detailed explanation of the price increase and sufficient information to enable the agency to determine that the proposed prices are fair and reasonable. The agency reserves the right to reject any offer for which the agency has determined that the prices are not fair and reasonable.

L.4 Incurring Costs

This solicitation does not commit the Government to pay any cost for the preparation and submission of a proposal. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed acquisition.

(End of Provision)

L.5 NOTICE OF INTENT TO AWARD WITHOUT DISCUSSIONS AND MAKE MULTIPLE AWARDS

It is the intention of the Government to evaluate proposals and award a contract or contracts without conducting discussions with Contractors.

The Government anticipates making a split award resulting in multiple contracts as a result of this solicitation.

(End of Provision)

L.6 FAR 52.233-2 Service of Protest (Sep 2006)

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Contracting Officer Annette Wright Team Lead Contracting Officer Office of Resource Management (ORM) Assistant Secretary for Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: owf8@cdc.gov| 404-498-0949 office

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

(End of provision)

L.7 Trade Agreement Compliance (TAA). The offeror must certify that the N95 Respirators are in compliance with TAA in accordance with the Federal Acquisition Regulation (FAR) 52.225-6 and are domestically manufactured.

(End of Provision)

L.8 General Instructions (Negotiated)

(a) Offerors are invited to submit a proposal in response to this solicitation. All proposals received will become part of the official file.

(b) The following instructions establish the acceptable minimum requirements for the format and content of proposals.

(c) Your proposal must be prepared in separate parts as instructed herein. Each part shall be separate and complete in itself so that evaluation of one may be accomplished independently of evaluation of the other(s). The technical proposal (if required) must not contain reference to cost; however, resource information, such as data concerning labor hours and categories, material, subcontracts, etc., must be contained in the technical proposal so that your understanding of the Statement of Work can be evaluated. The technical proposal (if required) must disclose your technical approach in sufficient detail to provide a clear and concise presentation that addresses, but is not limited to, the requirements of the technical proposal instructions.

(d) The proposal must be signed by an official authorized to bind your organization. You must submit electronically proposal to:

Contracting Officer Team Lead/Contracting Officer Office of Resource Management (ORM) Assistant Secretary for Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: owf8@cdc.gov| 404-498-0949 office

Attn: Annette R Wright Solicitation No. 75A50120R00008

(e) Offerors are requested to submit proposals, to the maximum extent possible, on high grade white paper which can be recycled.

(f) Facsimile proposals are not authorized.

(g) The Government will evaluate proposals in accordance with the evaluation criteria set forth in Section M, Evaluation Factors for Award.

(End of Provision)

L.9 EVALUATION PROCESS

The Government will perform evaluations based on the Offeror’s response to the solicitation, as described in section M, and in accordance with the evaluation factors for award as described in this section. The Government will conduct the evaluation based on the proposal being considered the best value to the ASPR/DSNS through the following Evaluation Factors:

Production/Delivery Schedule, Manufacturing…