idcardsRFP.doc.docm

Table of Contents

13-223-SOL-00028

Section B: Continuation of SF-1449 – Schedule of line items and pricing

Section C: Contract clauses, including agency-specific clauses

Section D: Exhibits, documents, and/or attachments

Section E: Instructions to offerors and evaluation criteria, including offeror Representations and Certifications.

Section B: Continuation of SF-1449, Schedule of line items and Pricing

B-1 Background

The U.S. Food and Drug Administration (FDA) is a regulatory agency with responsibility for the safety of food for humans and animals and the safety and efficacy of drug, devices and other medical products. In support of this regulatory mission, CVM and CFSAN laboratories which conducts analysis using VITEK 2. To increase the productivity in the laboratories, the Centers require identification cards for these VITEK 2 Compact automated identification instruments to run tests. These identification cards are required to identify organisms in samples, such as, but not limited to, Enterococcus, Salmonella, and Escherichia coli. The use of these cards in identifying organisms significantly reduces the time it takes to perform the identification which allows for quicker results and reduced costs to perform these tests.

B-2 Statement of Work

CVM and CFSAN require identification cards for the VITEK mass spectrometers. These cards are required to identify organisms in samples, such as, but not limited to, Enterococcus, Salmonella, and Escherichia coli. These cards must be compatible with the VITEK 2 Compact biochemical identification system in these laboratories. Specifically, CVM requires the following ID cards:

Specifications for the GN Cards: For the in vitro identification of Enterbacteriaceae and a select group of glucose nonfermenting gram-negative organisms.

Each card shall contain 64 wells Each card shall contain a pre-inserted transfer device.

Each card shall contain a unique barcode identifier.

Each card shall be covered with a labeled foil seal containing the lot number and expiration date.

Reactive ingredients shall contain: APPA, ADO, pyrA, IARL, dCEL, BGAL, H2S, BNAG, AGLTp, dGLU, GGT, OFF, BGLU, dMAL, dMAN, dMNE, BXYL, BAlap, proA, LIP, PLE, tyrA, URE, dSOR, SAC, dTAG, dTRE, CIT, MNT, 5KG, ILATk, AGLU,SUCT,NAGA,AGAL,PHOS,glyA,ODC,LDC,oDEC, IHISa, CMT, BGUR, 0129R, GGAA, IMLTa, ELLM, ILATa The laboratories must be able to use the cards with the VITEK2 Sysem.

GP Cards For the identification of enterococci, streptococci, staphylocci, and a select group of gram-positive organisms.

Each card shall contain 64 wells.

Each card shall contain a pre-inserted transfer device.

Each card shall contain a unique barcode identifier.

Each card shall be covered with a labeled foil seal containing the lot number and expiration date.

Reactive ingredients shall contain: AMY,PIPLC,dXYL,ADH1,BGAL,AGLU,APPA,CDEX,aspA,BGAR,AMAN, PHOS,leuA,proA,GBURr,AGAL,pyrA,BGUR,alaA,tyrA,dSOR,URE,POLYB, dGAL,dRIB,ILATk,LAC,NAG,dMAL,BACI,NOVO,NC6.5,dMAN,dMNE, MBdG,PUL,dRAF,0129R,SAL,SAC,dTRE,ADH2s,OPTO.

The laboratories must be able to use the cards with the VITEK2 System.

YEAST

For the identification of most significant yeasts and yeast like organisms.

Each card shall contain 64 wells.

Each card shall contain a pre-inserted transfer device.

Each card shall contain a unique barcode identifier.

Each card shall be covered with a labeled foil seal containing the lot number and expiration date.

Reactive ingredients shall contain:

lysA, IMLTa, leuA, ARG, ERYa, GLYLa, tryA, BNAG, ARBa, AMYa, dGALa, GENa, dGLUa, LACa, MAdGa, dCELa, GGT, dMALa, dRAFa, NAGA1, dMNEa, dMELa, dMLZa, ISBEa, IRHAa, XLTa, dSORa, SACa, URE, AGLU, dTURa, dTREa, NO3a, IARAa, dGATa, ESC, IGLTa, dXYLa, LATa, ACEa, CITa, GRTas, IPROa, 2KGa, NAGa, dGNTa

NH Cards For the identification of most clinically significant fastidious organisms.

Each card shall contain 64 wells.

Each card shall contain a pre-inserted transfer device.

Each card shall contain a unique barcode identifier.

Each card shall be covered with a labeled foil seal containing the lot number and expiration date.

Reactive ingredients shall contain:

argA, GGT, LysA, dGAL, LeuA, ELLM, PheA, ProA, PyrA, TyrA, APPA, dGLU, GLYG, dMNE, dMAL, SAC, NAG, URE, BGALi, ODC, AARA, PVATE, PHC, dMLT, MTE, IGLM, PHOS, dRIB2, OPS, dXLY

CVM’s Annual Quantity Estimate:

The figures below represents CVM’s yearly quantity estimate for boxes (quantity 20 cards per each box) for each type of card. These numbers are based on historical needs and may fluctuate in future years. These numbers are offered for estimation purposes only and do not represent an obligation by CVM. The catalog #’s supplied are the producer’s reference number for the cards.

CFSAN’s Annual Quantity Estimate:

The figures below represents CFSAN’s yearly quantity estimate for boxes (quantity 20 cards per each box) for each type of card. These numbers are based on historical needs and may fluctuate in future years. These numbers are offered for estimation purposes only and do not represent an obligation by CFSAN. The catalog #’s supplied are the producer’s reference number for the cards.

Task Orders/Delivery Schedule:

Due to limited storage capacity and fluctuations in work load, the FDA anticipates a quarterly delivery order which will define how many cards will be required over a three month period with multiple delivery dates. Particular delivery details will be provided in the delivery order issued.

Delivery:

The vendor will be responsible for delivery to CVM or CFSAN locations in Laurel, MD or College Park, MD which will be specified in each delivery order.

Point of Contacts:

· Project Officer: The Project Officer for the delivery orders will be the point of contact at the delivery location who will be responsible for receiving the deliveries, submitting delivery receipts to the COR, as well as communicating any pending issues to the COR. The Project Officer will be designated in the task orders.

· Contracting Officer’s Representative (COR): The COR for this contract is responsible for maintaining the contract record, timely receiving of receipts, for placing the bi-weekly order with the vendor, and for communicating with the Project Officer, Contracting Officer/Specialist, and vendor to ensure the vendor is meeting the requirements of the contract. The COR also requires the right to approve task orders before they are awarded in order to appropriately track the progress of the contract. The COR for this contract is Sean Kaurup.

The period of performance of this contract is 60 months from the effective date of the contract.

B-4 CONTRACT VEHICLE/DELIVERY ORDERS

As requirements are identified by the FDA, the Contracting Officer (CO) shall issue Delivery Orders (DOs) against the base IDIQ. The DOs shall be issued with a specific SOW on the funding document and will have a designated Contracting Officers Representative (COR).

The base IDIQ period of performance shall have a five (5) year ordering period. Use of this contract vehicle implies that all participating Delivery orders CORs will work cooperatively with the designated Base IDIQ COR, the Office of Acquisitions and Grants Services, follow all applicable laws and regulations, and only request services that are within the scope of this contract. The DO COR shall be responsible for obtaining consent for use of this contract vehicle from the designated Base IDIQ COR. The CO shall be responsible for negotiating a Dos, issuing all Dos, receiving reports approving invoices, overseeing all financial transactions, and implementing all Base IDIQ and Task modifications, as needed.

It is anticipated that the Tasks issued against this contract vehicle will be a Firm-Fixed-Price (FFP). All deliverables shall be clearly identified, complete with clear descriptions; due dates, and at a predetermined, agreed-upon price.

A period of performance will be specified for each Task. The SOW for each task shall specify any special acceptability standards for each deliverable, and all payments shall be made subject to the COR s acceptance. The COR shall have full project oversight responsibility for the work completed under the respective Task. However, all Task requirements and subsequent modifications shall be provided to the Base IDIQ COR to ensure compatibility with the existing scope of work.

The CO shall be the only Government Representative authorized to make any changes which either decrease or increase the Base IDIQ or Task or price. In addition, the CO is the only Government Representative authorized to change any terms or conditions of the Base IDIQ or any respective Task. Any proposed revisions shall be referred to the CO and shall require the submittal of a modification request, as well as concurrence from the designated COR.

All Dos created using the Base IDIQ will use pricing derived from the following pricing schedule in Section D.

B-5 Pricing Schedule IDIQ See Section “D” Exhibits, documents and/or attachments for list of items for the IDIQ.

B-6 MINIMUM AND MAXIMUM QUANTITIES

The contract guaranteed minimum will be met with the issuance of Task 1, see Section D, which will be awarded simultaneously with the contract.

The contract guaranteed maximum of all orders issued over 60 months and awarded under this contract shall not exceed $640,000.00 excluding any shipping costs.

B-7 FDA INVOICE SUBMISSION

The contractor shall submit vouchers or invoices in accordance with the following FAR clauses: 52.232-25, Prompt Payment (OCT 2008), and 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (OCT 2003); in accordance with the following instructions.

Contractor shall submit all invoices to all addresses in the manner specified below:

(I) One original and one copy to the Approving Official:

U.S. Food and Drug Administration Office of Acquisitions and Grants Services ATTN: Julia Savage, Contract Specialist 5630 Fishers Lane Room 2121, HFA 500 Rockville, MD 20857 E-MAIL: Julia.savage@fda.hhs.gov (II) One copy to the Contracting Officer Representative (COR) or other program center office designee clearly marked “Courtesy Copy Only”.

U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition ATTN: Sean Kaurup, Contracting Officer Representative

FDA-CVM

7529 Standish Pl.

Rockville, MD 20855 EMAIL: sean.kaurup@fda.hhs.gov ***Acceptable methods of delivery include: Mail, Hand Delivery or e-mail (B)Invoices submitted under this contract must comply with the requirements set forth in FAR 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer-Central Contractor Registration). To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and Address of the Contractor (II) Invoice date and invoice number (III) Purchase order/award number (IV) Description, quantity unit of measure, and extended price, and extended price supplies delivered or services performed, including: Period of Performance for which costs are claimed, itemized travel costs, including origin and destination, and any other supporting information necessary to clarify questionable expenditures.

(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. (Must be the same as that in the Purchase Order/Award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice.

(IX) Taxpayer identification number (TIN)

(X) Electronic funds transfer (EFT) Banking information including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited.

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order.

(XII) Any other information or documentation required by the purchase order/award.

(C) An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All listed in (I) thru (XII) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

(D) Questions regarding invoice payments should be directed to the FDA payment office at:

FDA/JOC/OA/OFS

ATTN: Division of Payment Services 10903 New Hampshire Ave Bldg 32, Room 2162, Mail Hub 2145 EMAIL: fdavendorpaymentsteam@fda.gov

Post Award Evaluation of Contractor Performance

a. Contractor Performance Evaluations Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted annually.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. ElectronicAccess to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through the Contractor Performance Assessment Reporting System (CPARS) web site, which is managed by the Department of Defense (DOD). Details regarding CPARS training and on-line registration can be found at http://www.cpars.csd.disa.mil/.

The registration process requires the Contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the Contractor will be required to identify an alternate contact who will be responsible for notifying the FDA contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

Section C: Contract clauses

C-1 52.252-2 Clauses Incorporated by Reference.

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

52.212-4 Contract Terms and Conditions Commercial Items.

Contract Terms and Conditions—Commercial Items (Feb 2012)

C-2 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items.

Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Nov 2012)

(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) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78).

(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. 253g and 10 U.S.C. 2402).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

__ (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.)

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Feb 2012) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) 52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Jul 2010) (Pub. L. 111-5).

_X_ (6) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Dec 2010) (31 U.S.C. 6101 note).

__ (7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Feb 2012) (41 U.S.C. 2313).

__ (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).

__ (9) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (10) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (JAN 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (11) [Reserved] __ (12)(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).

__ (13)(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.

__ (14) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3)).

__ (15)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2011) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Oct 2001) of 52.219-9.

__ (iii) Alternate II (Oct 2001) of 52.219-9.

__ (iv) Alternate III (Jul 2010) of 52.219-9.

__ (16) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)).

_X_ (17) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

__ (18) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (19)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (OCT 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

__ (ii) Alternate I (June 2003) of 52.219-23.

__ (20) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Dec 2010) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (21) 52.219-26, Small Disadvantaged Business Participation Program— Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f).

__ (23) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2012) (15 U.S.C. 632(a)(2)).

__ (24) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Apr 2012) (15 U.S.C. 637(m)).

__ (25) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Apr 2012) (15 U.S.C. 637(m)).

_X_ (26) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

__ (27) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Mar 2012) (E.O. 13126).

_X_ (28) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_X_ (29) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_X_ (30) 52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212).

_X_ (31) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

_X_ (32) 52.222-37, Employment Reports on Veterans (SEP 2010) (38 U.S.C. 4212).

_X_ (33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

__ (34) 52.222-54, Employment Eligibility Verification (JAN 2009). (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) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b).

__ (37)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (DEC 2007) (E.O. 13423).

__ (ii) Alternate I (DEC 2007) of 52.223-16.

__ (38) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513).

__ (39) 52.225-1, Buy American Act—Supplies (Feb 2009) (41 U.S.C. 10a-10d).

__ (40)(i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act (Mar 2012) (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, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, and Pub. L. 112-41).

__ (ii) Alternate I (Mar 2012) of 52.225-3.

__ (iii) Alternate II (Mar 2012) of 52.225-3.

__ (iv) Alternate III (Mar 2012) of 52.225-3.

__ (41) 52.225-5, Trade Agreements (MAR 2012) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (42) 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).

__ (43) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (44) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (45) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

__ (46) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

_X_ (47) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332).

__ (48) 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332).

__ (49) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332).

__ (50) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (51)(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.

(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) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (Nov 2007) (41 351, et seq.).

__ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

__ (7) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247).

__ (8) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)).

(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)(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 (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

(ii) 52.219-8, Utilization of Small Business Concerns (Dec 2010) (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 $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) [Reserved]

(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(v) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).

(vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

(vii) 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.

(viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

(ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

(xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

(xii) 52.222-54, Employment Eligibility Verification (JAN 2009).

(xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xiv) 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.

C-3 52.216-18 Ordering.

Ordering (Oct 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from ___TBD_______ through _____TBD_______ (Anticipated).

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered “issued” when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

C-4 52.216.19 Order Limitations Order Limitations (Oct 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than _$1,000.00____________ the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of _$640,000.00____________

(2) Any order for a combination of items in excess of ___$640,000.00_________ or

(3) A series of orders from the same ordering office within _____10________ days that together call for quantities exceeding the limitation in paragraph (b) (1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within __10___ days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

C-5 52.216-22 Indefinite Quantity.

Indefinite Quantity (Oct 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after August 30, 2017.

52.222-17 Nondisplacement of Qualified Workers.

Nondisplacement of Qualified Workers (Jan 2013)

(a) “Service employee”, as used in this clause, means any person engaged in the performance of a service contract other than any person employed in a bona fide executive, administrative, or professional capacity, as those terms are defined in 29 CFR part 541. The term “service employee” includes all such persons regardless of any contractual relationship that may be alleged to exist between a contractor or subcontractor and such persons.

(b) The Contractor and its subcontractors shall, except as otherwise provided herein, in good faith offer those service employees employed under the predecessor contract whose employment will be terminated as a result of award of this contract or the expiration of the contract under which the service employees were hired, a right of first refusal of employment under this contract in positions for which the service employees are qualified.

(1) The Contractor and its subcontractors shall determine the number of service employees necessary for efficient performance of this contract and may elect to employ fewer employees than the predecessor Contractor employed in connection with performance of the work.

(2) Except as provided in paragraph (c) of this clause, there shall be no employment opening under this contract, and the Contractor and any subcontractors shall not offer employment under this contract, to any person prior to having complied fully with this obligation.

(i) The successor Contractor and its subcontractors shall make a bona fide express offer of employment to each service employee as provided herein and shall state the time within which the service employee must accept such offer, but in no case shall the period within which the service employee must accept the offer of employment be less than 10 days.

(ii) The successor Contractor and its subcontractors shall decide any question concerning a service employee’s qualifications based upon the individual’s education and employment history, with particular emphasis on the employee's experience on the predecessor contract, and the Contractor may utilize employment screening processes only when such processes are provided for by the contracting agency, are conditions of the service contract, and are consistent with Executive Order 13495.

(iii) Where the successor Contractor does not initially offer employment to all the predecessor contract service employees, the obligation to offer employment shall continue for 90 days after the successor contractor’s first date of performance on the contract.

(iv) An offer of employment will be presumed to be bona fide even if it is not for a position similar to the one the employee previously held, but is one for which the employee is qualified, and even if it is subject to different employment terms and conditions, including changes to pay or benefits. (See 29 CFR 9.12 for a detailed description of a bonafide offer of employment).

(c)(1) Notwithstanding the obligation under paragraph (b) of this clause, the successor Contractor and any subcontractors (i) may employ under this contract any service employee who has worked for the contractor or subcontractor for at least three months immediately preceding the commencement of this contract and who would otherwise face lay-off or discharge, (ii) are not required to offer a right of first refusal to any service employee(s) of the predecessor contractor who are not service employees within the meaning of the Service Contract Act, 41 U.S.C. 6701(3), and (iii) are not required to offer a right of first refusal to any service employee(s) of the predecessor contractor whom the Contractor or any of its subcontractors reasonably believes, based on the particular service employee’s past performance, has failed to perform suitably on the job (see 29 CFR 9.12 (c)(4) for additional information). The successor Contractor bears the responsibility of demonstrating the appropriateness of claiming any of these exceptions.

(2) In addition, any Contractor or subcontractor that has been certified by the U.S. Small Business Administration as a HUBZone small business concern must ensure that it complies with the statutory and regulatory requirements of the HUBZone Program (e.g., it must ensure that at least 35 percent of all of its employees reside within a HUBZone). The HUBZone small business Contractor or subcontractor must consider whether it can meet the requirements of this clause and Executive Order 13495 while also ensuring it meets the HUBZone Program’s requirements.

(3) Nothing in this clause shall be construed to permit a Contractor or subcontractor to fail to comply with any provision of any other Executive order or law. For example, the requirements of the HUBZone Program (see FAR subpart 19.13), Executive Order 11246 (Equal Employment Opportunity), and the Vietnam Era Veterans’ Readjustment Assistance Act of 1974 may conflict, in certain circumstances, with the requirements of Executive Order 13495. All applicable laws and Executive orders must be satisfied in tandem with, and if necessary prior to, the requirements of Executive Order 13495, 29 CFR part 9, and this clause.

(d)(1) The Contractor shall, not less than 30 days before completion of the Contractor’s performance of services on the contract, furnish the Contracting Officer with a certified list of the names of all service employees working under this contract and its subcontracts at the time the list is submitted. The list shall also contain anniversary dates of employment of each service employee under this contract and its predecessor contracts with either the current or predecessor contractors or their subcontractors. Where changes to the workforce are made after the submission of the certified list described in this paragraph, the Contractor shall, in accordance with paragraph (e) of this clause, not less than 10 days before completion of the services on this contract, furnish the Contracting Officer with an updated certified list of the names of all service employees employed within the last month of contract performance. The updated list shall also contain anniversary dates of employment, and, where applicable, dates of separation of each service employee under the contract and its predecessor contracts with either the current or predecessor Contractors or their subcontractors.

(2) Immediately upon receipt of the certified service employee list but not before contract award, the contracting officer shall provide the certified service employee list to the successor contractor, and, if requested, to employees of the predecessor contractor or subcontractors or their authorized representatives.

(3) The Contracting Officer will direct the predecessor Contractor to provide written notice (Appendix B to 29 CFR chapter 9) to service employees of their possible right to an offer of employment with the successor contractor. Where a significant portion of the predecessor Contractor’s workforce is not fluent in English, the notice shall be provided in English and the language(s) with which service employees are more familiar. The written notice shall be—

(i) Posted in a conspicuous place at the worksite; or

(ii) Delivered to the service employees individually. If such delivery is via e-mail, the notification must result in an electronic delivery receipt or some other reliable confirmation that the intended recipient received the notice.

(e)(1) If required in accordance with 52.222-41(n), the predecessor Contractor shall, not less than 10 days before completion of this contract, furnish the Contracting Officer a certified list of the names of all service employees working under this contract and its subcontracts during the last month of contract performance. The list shall also contain anniversary dates of employment of each service employee under this contract and its predecessor contracts either with the current or predecessor Contractors or their subcontractors. If there are no changes to the workforce before the predecessor contract is completed, then the predecessor Contractor is not required to submit a revised list 10 days prior to completion of performance and the requirements of 52.222-41(n) are met. When there are changes to the workforce after submission of the 30-day list, the predecessor Contractor shall submit a revised certified list not less than 10 days prior to performance completion.

(2) Immediately upon receipt of the certified service employee list but not before contract award, the contracting officer shall provide the certified service employee list to the successor contractor, and, if requested, to employees of the predecessor contractor or subcontractors or their authorized representatives.

(f) The Contractor and subcontractor shall maintain the following records (regardless of format, e.g., paper or electronic) of its compliance with this clause for not less than a period of three years from the date the records were created.

(1) Copies of any written offers of employment or a contemporaneous written record of any oral offers of employment, including the date, location, and attendance roster of any service employee meeting(s) at which the offers were extended, a summary of each meeting, a copy of any written notice that may have been distributed, and the names of the service employees from the predecessor contract to whom an offer was made.

(2) A copy of any record that forms the basis for any exemption claimed under this part.

(3) A copy of the service employee list provided to or received from the contracting agency.

(4) An entry on the pay records of the amount of any retroactive payment of wages or compensation under the supervision of the Administrator of the Wage and Hour Division to each service employee, the period covered by such payment, and the date of payment, and a copy of any receipt form provided by or authorized by the Wage and Hour Division. The Contractor shall also deliver a copy of the receipt to the service employee and file the original, as evidence of payment by the Contractor and receipt by the service employee, with the Administrator or an authorized representative within 10 days after payment is made.

(g) Disputes concerning the requirements of this clause shall not be subject to the general disputes clause (52.223-1) of this contract. Such disputes shall be resolved in accordance with the procedures of the Department of Labor set forth in 29 CFR part 9. Disputes within the meaning of this clause include disputes between or among any of the following: The Contractor, the contracting agency, the U.S. Department of Labor, and the service employees under the contract or its predecessor contract. The Contracting Officer will refer any service employee who wishes to file a complaint, or ask questions concerning this contract clause, to the: Branch of Government Contracts Enforcement, Wage and Hour Division, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210. Contact e-mail: displaced@dol.gov.

(h) The Contractor shall cooperate in any review or investigation by the Department of Labor into possible violations of the provisions of this clause and shall make such records requested by such official(s) available for inspection, copying, or transcription upon request.

(i) If it is determined, pursuant to regulations issued by the Secretary of Labor (Secretary), that the Contractor or its subcontractors are not in compliance with the requirements of this clause or any regulation or order of the Secretary, appropriate sanctions may be imposed and remedies invoked against the Contractor or its subcontractors, as provided in Executive Order 13495, the regulations, and relevant orders of the Secretary, or as otherwise provided by law.

(j) The Contractor shall take such action with respect to any such subcontract as may be directed by the Secretary of Labor as a means of enforcing such provisions, including the imposition of sanctions for noncompliance. However, if the Contractor, as a result of such direction, becomes involved in litigation with a subcontractor, or is threatened with such involvement, the Contractor may request that the United States, through the Secretary, enter into such litigation to protect the interests of the United States.

(k) The Contracting Officer will withhold, or cause to be withheld, from the prime Contractor under this or any other Government contract with the same prime Contractor, such sums as an authorized official of the Department of Labor requests, upon a determination by the Administrator, the Administrative Law Judge, or the Administrative Review Board, that there has been a failure to comply with the terms of this clause and that wages lost as a result of the violations are due to service employees or that other monetary relief is appropriate. If the Contracting Officer or the Administrator, upon final order of the Secretary, finds that the Contractor has failed to provide a list of the names of service employees working under the contract, the Contracting Officer may, in his or her discretion, or upon request by the Administrator, take such action as may be necessary to cause the suspension of the payment of contract funds until such time as the list is provided to the Contracting Officer.

(l) Subcontracts. In every subcontract over the simplified acquisition threshold entered into in order to perform services under this contract, the Contractor shall include a provision that ensures—

(1) That each subcontractor will honor the requirements of paragraphs (b) through (c) of this clause with respect to the service employees of a predecessor subcontractor or subcontractors working under this contract, as well as of a predecessor Contractor and its subcontractors;

(2) That the subcontractor will provide the Contractor with the information about the service employees of the subcontractor needed by the Contractor to comply with paragraphs (d) and (e) of this clause; and

(3) The recordkeeping requirements of paragraph (f) of this clause.

C-6 HHSAR CLAUSES INCORPORATED BY REFERENCE

This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, wit 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: http://farsite.hill.af.mil/VFHHSARA>HTM

HHSAR Clause Description Date

352.202-1 Definitions (Jan2006) 352.203-70 Anti-Lobbying (Jan2006)

Section D Exhibits, documents, and/or attachments

Yr.1

The quantities above are for each of the five years and will be used for evaluation purposes, however the prices will be set forth for each year in the awarded contract.

This will be Task 1, issued with the base contract. The offeror shall provide a price for this Task with a separate line for shipping charges if applicable.

Delivery instructions:

Food & Drug Administration Attn: Sean Kaurap 8401 Muirkirk Rd Laurel MD, 20708

Section E: Instructions to offerors and evaluation criteria, including offeror Representations and Certifications.

E-1 Notice Listing Solicitation Provisions Incorporated by Reference

This solicitation incorporates one or more solicitations 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.

NUMBER TITLE DATE

52.204.6 Data Universal Numbering System (DUNS) Number (Dec 2012) 52.212-1 Instructions to Offerors—Commercial Items. (FEB 2012)

E-2 52.216-1 Type of Contract.

Type of Contract (Apr 1984) The Government contemplates that fixed price delivery orders will be placed against the IDIQ contract, resulting from this solicitation.

E-3 52.233-2 Service of Protest.

Service of Protest (Sept 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…