Brand Name or Equal Tarceva Tablets

Brand Name or Equal Tarceva Tablets(Expired)
From: Federal Government(Federal)

Opportunity Type

Bid Notification

Opportunity Identifier

75N91020Q00010

Customer / Agency

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Location

ROCKVILLE , MD 20852
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**PLEASE REFER TO THE ATTACHED SOLICITATION IF THE DESCRIPTION FORMATTING IS INCONSISTENT**

The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP) has a requirement for brand name or equal Tarceva tablets.
This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice, and shall be processed in accordance with FAR Part 13 – Simplified Acquisition Procedures. This announcement constitutes the only solicitation and a separate written solicitation will not be issued.  This solicitation, 75N91020Q00010, is issued as a request for quote (RFQ) and includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2019-05 (08-13-2019) simplified acquisition procedures for commercial items. 
The North American Industry Classification System code is 325412 and the business size standard is 1250 employees. 
Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price purchase order. 


1.0          BRAND NAME OR EQUAL

This requirement is for the procurement of brand name or equal Tarceva tablets. The Federal Acquisition Regulation (FAR) provision FAR 52.211-6, Brand Name or Equal (AUG 1999) is applicable to this requirement.


SCOPE

The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) requires brand name or equal Tarceva tablets for clinical trial NCI Protocol A081105 “Randomized Study of Erlotinib Vs Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC).”
Erlotinib is an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase currently FDA- approved for patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. In some tumor cells signaling through this receptor plays a role in tumor cell survival and proliferation irrespective of EGFR mutation status. Erlotinib reversibly inhibits the kinase activity of EGFR, preventing autophosphorylation of tyrosine residues associated with the receptor and thereby inhibiting further downstream signaling.
 

TYPE OF ORDER

This is a Firm Fixed-Price Purchase Order.


SPECIAL ORDER REQUIREMENTS


The Contractor shall be a FDA-approved manufacturer or authorized distributor of the FDA-approved drug product in the United States or a health authority (e.g., regulatory approved by the country authority equivalent to the United States Food and Drug Administration) approved drug product manufacturer of the commercial product in the country of origin.  
If the commercial product is from a non-United States FDA approved manufacturer in another country, the Contractor shall provide a complete Chemistry, Manufacturing and Control (CMC) package, such as manufacturing information for the drug substance and drug product, formulation, specifications, batch data, container closure system, and available stability data that can be submitted to the NCI IND on file with the U.S. FDA for the clinical trial.
If the commercial product is from a non-United States FDA approved manufacturer in another country, the Contractor shall provide a point of contact at the manufacturing company that can respond to any questions posed by the FDA regarding the agent manufacturing controls. The point of contact shall be identified in the submitted quote.
If the commercial product is from a non-United States FDA approved manufacturer in another country, the Contractor shall ship the product for import under existing DCTD, NCI-sponsored IND 120723 on file with the U.S. Food and Drug Administration (FDA).






PRODUCT FEATURES/SALIENT CHARACTERISTICS

The Contractor shall provide the following product with features/characteristics as described:


Tarceva 25 mg (Brand Name or equivalent):

Tablet formulation, film-coated



Tablets containing erlotinib hydrochloride equivalent to 25 mg of erolitinib as the free-base
15 bottles containing 30 tablets each
Tarceva 100 mg tablets (Brand Name or equivalent):

Tablet formulation, film-coated
Tablets containing erlotinib hydrochloride equivalent to 100 mg of erolitinib as the free-base
15 bottles containing 30 tablets each:
Tarceva 150 mg tablets (Brand Name or equivalent):

Tablet formulation, film-coated
Tablets containing erlotinib hydrochloride equivalent to 150 mg of erolitinib as the free-base
30 bottles containing 30 tablets each
Expiration date shall not be less than 12-months from the date of receipt by the NCI.
Bottles shall be stored and shipped at controlled room temperature (20-25OC) with temperature monitoring devices included in the shipping container.




DELIVERY

All shipping/handling (including FOB) and delivery fees shall be included in the quote. Items shall be shipped and delivered under temperature-controlled conditions in accordance with the storage conditions defined on the drug product container label to ensure maintenance of required temperature conditions from the time of shipment until the time of delivery.
Temperature monitoring devices shall be included in the shipping container.
All items shall be delivered within 30 days of the purchase order award to the following address:

NCI Clinical Repository
4650 New Design Road, Suite D
Frederick, MD 21703

PAYMENT

Payment shall be made upon delivery, inspection and acceptance by the Government. Payment authorization requires submission and approval of invoices to the NCI Technical Point of Contact and NIH OFM, in accordance with the payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: PROMPT PAYMENT (JAN 2017) FAR 52.232-25
.



Highlights of this clause and NIH implementation requirements follow:


INVOICE REQUIREMENTS




An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed.  A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9.  If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice.  (See exceptions under II., below.)  Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor.






Vendor/Contractor:  Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).
Remit-to address (Name and complete mailing address to send payment).
Remittance name must match exactly with name on original order/contract.  If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.
Invoice date.
Unique invoice #s for all invoices per vendor regardless of site.
NBS document number formats must be included for awards created in the NBS:  Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.
Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).
Federal Taxpayer Identification Number (TIN).  In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice.  The VIN is the number that appears after the contractor’s name on the face page of the award document.
Identify that payment is to be made using a three-way match.
Description of supplies/services that match the description on the award, by line billed.*
Freight or delivery charge must be billed as shown on the award.  If it is included in the item price do not bill it separately.  If identified in the award as a separate line item, it must be billed separately.
Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

* NOTE:  If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice.  A modification to the order or contract may be needed before the invoice can be submitted and paid.




Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order.  If authorized, shipping costs must be itemized.  Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.




Mail an original and 1 copy of the itemized invoice to:

National Institutes of Health
Office of Financial Management, Commercial Accounts
                2115 East Jefferson Street, Room 4B-432, MSC 8500
Bethesda, MD 20892-8500

For inquiries regarding payment call: (301) 496-6088

In order to facilitate the prompt payment of invoices, it is recommended that the vendor submit a photocopy of the invoice to the “Consignee” designated for the acquisition in blocks 6A – 6E of the face page of the Order/Award document.

II. INVOICE PAYMENT


Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.
2. The 30th day after Government acceptance of supplies delivered or services
    performed.
 

    The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.


           INTEREST PENALTIES


    An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.
1. A proper invoice was received by the designated billing office.
2. A receiving report or other Government documentation authorizing payment was 
    processed and there was no disagreement over quantity, quality, or contractor
    compliance with a term or condition.
3. In the case of a final invoice for any balance of funds due the contractor for supplies
    delivered or services performed, the amount was not subject to further settlement
    actions between the Government and the Contractor.


Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS 
    SUBCONTRACTORS, FAR 52.232-40 (DEC 2013)


Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor. 
The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.
Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.


PURCHASE ORDER CLAUSES

FAR 52.204-25 PROHIBITION ON CONTRACTING FOR CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (AUG 2019)

Definitions. As used in this clause—

Covered foreign country means The People’s Republic of China.

Covered telecommunications equipment or services means-




Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities);
For the purpose of public safety, security of Government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities);
Telecommunications or video surveillance services provided by such entities or using such equipment; or
Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered foreign country.
Critical technology means-


Defense articles or defense services included on the United States Munitions List set forth in the International Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;
Items included on the Commerce Control List set forth in Supplement No. 1 to part 774 of the Export Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and controlled—

Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological weapons proliferation, nuclear nonproliferation, or missile technology; or
For reasons relating to regional stability or surreptitious listening;
Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology covered by part 810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy activities);
Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations (relating to export and import of nuclear equipment and material);
Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such Code, or part 73 of title 42 of such Code; or
 
Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act of 2018 (50 U.S.C. 4817).
Substantial or essential component means any component necessary for the proper function or performance of a piece of equipment, system, or service.

Prohibition. Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. The Contractor is prohibited from providing to the Government any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, unless an exception at paragraph (c) of this clause applies or the covered telecommunication equipment or services are covered by a waiver described in Federal Acquisition Regulation 4.2104.
Exceptions. This clause does not prohibit contractors from providing—




A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or
Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any user data or packets that such equipment transmits or otherwise handles.
Reporting requirement.




In the event the Contractor identifies covered telecommunications equipment or services used as a substantial or essential component of any system, or as critical technology as part of any system, during contract performance, or the Contractor is notified of such by a subcontractor at any tier or by any other source, the Contractor shall report the information in paragraph (d)(2) of this clause to the Contracting Officer, unless elsewhere in this contract are established procedures for reporting the information; in the case of the Department of Defense, the Contractor shall report to the website at https://dibnet.dod.mil. For indefinite delivery contracts, the Contractor shall report to the Contracting Officer for the indefinite delivery contract and the Contracting Officer(s) for any affected order or, in the case of the Department of Defense, identify both the indefinite delivery contract and any affected orders in the report provided at https://dibnet.dod.mil.




The Contractor shall report the following information pursuant to paragraph (d)(1) of this clause:

Within one business day from the date of such identification or notification: the contract number; the order number(s), if applicable; supplier name; supplier unique entity identifier (if known); supplier Commercial and Government Entity (CAGE) code (if known); brand; model number (original equipment manufacturer number, manufacturer part number, or wholesaler number); item description; and any readily available information about mitigation actions undertaken or recommended.
Within 10 business days of submitting the information in paragraph (d)(2)(i) of this clause: any further available information about mitigation actions undertaken or recommended. In addition, the Contractor shall describe the efforts it undertook to prevent use or submission of covered telecommunications equipment or services, and any
additional efforts that will be incorporated to prevent future use or submission of covered telecommunications equipment or services.
Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (e), in all subcontracts and other contractual instruments, including subcontracts for the acquisition of commercial items.
FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS -- COMMERCIAL ITEMS (AUG 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)).
(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) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (
Nov 2015).
(5) 52.233-3, Protest After Award (
Aug 1996) (31 U.S.C. 3553).
(6) 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:
_
__ (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.
_X_ (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]
___ (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)).
___ (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 (Dec 2015) (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).
_
__ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).
_X_ (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.
___ (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 2014) (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).
_X_ (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 disputes 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) 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) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).\
(v) 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.
(vi) 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.
(vii) 52.222-21, Prohibition of Segregated Facilities (
Apr 2015).
(viii) 52.222-26, Equal Opportunity (
Sept 2015) (E.O.11246).
(ix) 52.222-35, Equal Opportunity for Veterans (
Oct 2015) (38 U.S.C.4212).
(x) 52.222-36, Equal Opportunity for Workers with Disabilities (
Jul 2014) (29 U.S.C.793).
(xi) 52.222-37, Employment Reports on Veterans (
Feb 2016) (38 U.S.C.4212)
(xii) 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.
(xiii) 52.222-41, Service Contract Labor Standards (
Aug 2018) (41 U.S.C. chapter 67).
(A) (xiv) 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).
(xv) 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).
(xvi) 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).
(xvii) 52.222-54, Employment Eligibility Verification (
Oct 2015) (E.O. 12989).
(xviii) 52.222-55, Minimum Wages Under Executive Order 13658 (
Dec 2015).
(xix) 52.222-62, Paid Sick Leave Under Executive Order 13706 (
Jan 2017) (E.O. 13706).
(xx) (A) 52.224-3, Privacy Training (
Jan 2017) (5 U.S.C. 552a).
(B) Alternate I (
Jan 2017) of 52.224-3.
(xxi) 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).
(xxii) 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.
(xxiii) 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.
FAR 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/far/ and/or http://www.hhs.gov/policies/hhsar/.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) PROVISIONS:
CLAUSE NO.                       
TITLE
FAR 52.203-18                   PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS-REPRESENTATION (JAN 2017)
FAR 52.203-19                    PROHIBITION ON REQUIRING CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS (JAN 2017)
FAR 52.212-4                      CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (OCT 2018)
52.247-35                            F.O.B. DESTINATION, WITHIN CONSIGNEE’S PREMISES (APR 1984)

HEALTH AND HUMAN SERICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) PROVISIONS:

CLAUSE NO.                       
TITLE

HHSAR 352.222-70           CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY                                                                  INVESTIGATION (DEC 2015)
HHSAR 352.224–71          CONFIDENTIAL INFORMATION (DEC 2015)

HHSAR 352.227–70          PUBLICATIONS AND PUBLICITY (DEC 2015)
HHSAR 352.237–74          NON-DISCRIMINATION IN SERVICE DELIVERY (DEC 2015)
 

SOLICITATION PROVISIONS
FAR 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (AUG 2019)

Definitions. As used in this provision—

Covered telecommunications equipment or services,
Critical technology, and
Substantial or essential
component have the meanings provided in clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Prohibition. Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Contractors are not prohibited from providing—

A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or
Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any user data or packets that such equipment transmits or otherwise handles.
Representation. The Offeror represents that—

It [ ] will, [ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation.

Disclosures. If the Offeror has responded affirmatively to the representation in paragraph (c) of this provision, the Offeror shall provide the following information as part of the offer—

All covered telecommunications equipment and services offered (include brand; model number, such as original equipment manufacturer (OEM) number, manufacturer part number, or wholesaler number; and item description, as applicable);
Explanation of the proposed use of covered telecommunications equipment and services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b) of this provision;
For services, the entity providing the covered telecommunications services (include entity name, unique entity identifier, and Commercial and Government Entity (CAGE) code, if known); and
For equipment, the entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known).

FAR 52.211-6 BRAND NAME OR EQUAL (AUG 1999)
(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.
(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must-
(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;
(2) Clearly identify the item by-
(i) Brand name, if any; and
(ii) Make or model number;
(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and
(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.
(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.
(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.
FAR 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/far/ and/or http://www.hhs.gov/policies/hhsar/.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) PROVISIONS:
CLAUSE NO.                       
TITLE
FAR 52.204-22                    ALTERNATIVE LINE ITEM PROPOSAL (JAN 2017)
FAR 52.212-1                      INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (OCT 2018)  
FAR 52.212-2                     EVALUATION-COMMERCIAL ITEMS (OCT 2014)
FAR 52.214-21                   DESCRIPTIVE LITERATURE (APR 2002)
 
7.0          SUBMISSION INSTRUCTIONS/EVALUATION

QUESTIONS
Questions must be submitted electronically via email to Contracting Officer, Miguel Diaz, at miguel.diaz@nih.gov in MS Word or Adobe Portable Document Format (PDF),
no later than 1:00 P.M. EST on Wednesday, December 11, 2019 (12/11/2019). Please be advised that the Government reserves the right to transmit any questions and answers of a common interest to all prospective Contractors.

QUOTATIONS
Quotations must be submitted electronically via email to Contracting Officer, Miguel Diaz, at miguel.diaz@nih.gov in MS Word or Adobe Portable Document Format (PDF),
no later than 1:00 P.M. EST on Monday, December 16, 2019 (12/16/2019). QUOTATIONS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.
Please refer to solicitation no: 75N91020Q00010 on all correspondence.

BASIS FOR AWARD & EVALUATION
The purchase order will be awarded to the firm that submits the Lowest Price Technically Acceptable (LPTA) quotation. A technically acceptable quote is one in which the quoter(s) complies with the Statement of Work (SOW) and does not take exception, nor object to any of the terms of the RFQ. Quotes that are not technically acceptable will not be considered for award. Award will be made on an all or none basis.
If you are providing an “equal” product, you must submit additional documentation that highlights and describes how your offering is equal in accordance with FAR Clause 52.211-6.
Evaluation and award will be conducted in accordance with the requirements of FAR 13.106. The technical evaluation will be a determination based on information furnished by the Contractor. The Government is not responsible for locating or securing any information which is not identified in the quotation. The Government intends to evaluate quotations and make a single award without conducting "discussions" as defined in FAR Part 15. Therefore, the quoter’s initial quote should contain the quoter’s best terms from a price and technical standpoint. However, the Government reserves the right to request quote revisions that seek additional price discounts, provide revisions to the technical quote, or clarify aspects of the quote.  In the event quote revisions are requested, the Government will not necessarily be seeking revisions from all quoters. The Government may reject any or all quotes if such action is in the public interest; accept other than the lowest quote; and waive informalities and minor irregularities in quotes received.

GENERAL INSTRUCTIONS
This Request for Quotation (RFQ) does not commit the Government to pay any cost for preparation and submission of a quote. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition. By submitting a quote in response to this solicitation, it is understood that your firm’s quote shall become a part of the official contract file.

Quotes must be submitted with a completed copy of FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment, located in section 6.0 of this RFQ.

Price Quote:
The quoter shall prepare a price quotation that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. The quote must contain the following information:
 
a. Federal Tax Identification Number (TIN);
b. Data Universal Numbering System (DUNS) Number;
c. Business Size (e.g., small or large)

**Please include a statement to the effect that pricing is firm for a period of at least
60 days from the date of receipt thereof by the Government.

Product Service Code:- 6505 - DRUGS AND BIOLOGICALS
NAICS Code:- 325412 - Pharmaceutical Preparation Manufacturing
Primary point of contact:- Miguel Diaz  
miguel.diaz@nih.gov  
Phone Number 2402765439
Secondary point of contact:-

Dates

Start Date

06 Dec, 2019 (8 months ago)

Due Date

16 Dec, 2019 (7 months ago)

Location

Country : United States State : Maryland