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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 05, 2013 FBO #4241
SOLICITATION NOTICE

B -- Manufacture of Tobacco Filler Material - FDA-SOL-1116263

Notice Date

7/3/2013
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

312230 — Tobacco Manufacturing
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-SOL-1116263
 

Archive Date

8/17/2013
 

Point of Contact

Natalie Mitchell, Phone: 3018279606
 

E-Mail Address

natalie.mitchell@fda.hhs.gov
(natalie.mitchell@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

Solicitation Subject: Production of Tobacco Filler Reference Material Solicitation Number: FDA-SOL-1116263 PART 1 - BACKGROUND Tobacco use is the leading cause of preventable diseases in the United States and is responsible for more than 443,000 deaths annually. On June 22, 2009, the president signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law. The Tobacco Control Act added sections 904(a)(1), 904(a)(3), and 915 to the Federal Food, Drug, & Cosmetic Act (FD&C Act). These provisions require each tobacco product manufacturer or importer, or an agent, to test and report constituents, ingredients, and additives to FDA. Furthermore, section 907 of the FD&C Act requires FDA to establish product standards for tobacco products. In order to successfully implement these provisions and ensure quality control of methods used for tobacco analysis, a standard tobacco filler reference material with defined quantities of particular constituents is needed. Section 906 of the Tobacco Control Act provides FDA with the authority to enter into contracts for research, testing, and demonstrations of tobacco products and to obtain products for research, testing, and demonstration purposes. Based on this authority, FDA is seeking the services of a contactor capable of manufacturing tobacco filler based on specifications established by FDA and shipping the tobacco product to the National Institute of Standards and Technology (NIST). The tobacco filler will undergo thorough analytical testing under the direction of NIST and the levels of various substances present in the tobacco filler will be certified. This tobacco filler will provide a long term, reliable standard by which various testing methods can be examined and validated for accuracy and precision. PART 2 - DESCRIPTION THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-68. The associated North American Industrial Classification System (NAICS) code for this procurement is 312230 with a size standard of 1,000 employees. This is a RFQ for the Manufacture of Tobacco Filler Reference Material PART 3 - SUPPLIES OR SERVICES AND PRICES/COSTS DESCRIPTION OF SUPPLIES & SERVICES The FDA has a requirement for the manufacture of Tobacco Filler Reference Material, intended to be validated as a Standard Tobacco Reference Material. 3.1 Contract Type 3.1.1 Single-award, fixed price. Pricing Table: Table 1 Amount (kg) Price per kg Total Price 2,500 PART 4 - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT Statement of Work Task 1 The Contractor shall manufacture and package 2,500 kilograms of tobacco filler (per requirements listed below). The tobacco filler shall be homogenous. The tobacco filler shall contain the minimal amount of additional ingredients or processing aids as possible. The Contractor shall provide a written report containing a detailed account of the exact procedures used to manufacture and blend the tobacco filler. The Contractor shall allow representatives from FDA and NIST to observe the blending and packaging of the tobacco filler, if requested by the agencies. The contractor shall store the tobacco containers at ambient temperature while at the contractor's facility. Task 2 The Contractor shall take three random samples of tobacco filler from each shipping container. The samples will be sealed, shipped, and analyzed by an independent third party ISO 17025 accredited laboratory for oven volatiles, nicotine, NNN, and NNK to verify the tobacco filler meets the desired specifications. The results of the analyses are to be delivered directly to FDA within 21 days of the packaging date. Task 3 Upon acceptance by FDA that the filler material meets the desired specifications, the contractor shall ship the tobacco filler to the designated Delivery Point no later than 75 days after contract award. Schedule Written Report - Contractor shall complete a written report at the time the samples are sent for independent analysis. Observing Blending and Packaging - FDA and NIST will observe during real time manufacturing of the product. Shipping of Samples - The Contractor shall take 3 random samples and send to the Independent Third Party for analysis. Analysis of Samples - The Independent Third Party has 21 days, from the date the package was shipped to them, to send the results/reports to FDA. FDA: Center for Tobacco Products Attn: Stephanie Durkin 9200 Corporate Blvd. Rockville, MD 20850 Review of Results - FDA has 7 days in which to review the results from the independent lab to determine whether or not the filler product will be accepted or rejected. Delivery and Acceptance - The Contractor has a total of 90 days to complete tobacco filler. The Tobacco Filler Reference Material must meet the specified requirements or the end product will not be accepted. Requirements for Tobacco Filler Reference Material Table 2 Product Property Desired Specification Filler *Tobacco Type specified by contractor Oven Volatiles 13% Tobacco Size 30 cuts per inch Nicotine Content 0.3 mg/g or less NNN (N-nitrosonornicotine) Content 1000 ng/g or less NNK (4-(methylnitrosamino)1-(3-pyridyl)-1-butanone) Content 250 ng/g or less **Other ingredients Least amount possible Packaging & Labeling Packaging Bulk sealed packaging. *Contractor shall inform FDA what type of tobacco is being used. **Contractor shall provide details about both the processing additives and the tobacco type. PART 5- DELIVERABLES- 5.1 The Contractor shall deliver research standard tobacco filler to NIST with no partial shipments. Shipping must be free on board (FOB) destination CONUS (Continental U.S.), which means that the seller must deliver the goods on its conveyance at the destination specified by the buyer, and the seller is responsible for the cost of shipping and risk of loss prior to actual delivery at the specified destination: NIST 100 Bureau Dr. Gaithersburg, MD 20899 Payment Schedule Task Percentage of Total Fixed Price to be Invoiced Task 1-Manufacture of tobacco filler material and report detailing procedures used 20% Task 2-Sending samples to independent laboratory for verification filler meets specifications 10% Task 3-Final delivery of filler material to desired location no later than 75 days after award 70% PART 6 - INSPECTION AND ACCEPTANCE 6. The Contracting Officer's Representative (COR) will perform inspection and acceptance of materials and services to be provided. 6.1. For the purpose of this part, Stephanie Durkin (COR) is the authorized representative of the Contracting Officer. 6.2. Inspection and acceptance will be performed at the location of the laboratory. Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer or the COR within 30 days of receipt. PART 7 - CONTRACT ADMINISTRATION DATA 7. CONTRACTING OFFICERS REPRESENTATIVE (COR) 7.1. The following COR will represent the Government for the purpose of this contract: Stephanie Durkin 7.1.1. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. CONTRACTING OFFICER (COR) 7.1.2. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. 7.1.3. The contact information for the Contract Specialist is: Natalie Mitchell 5630 Fishers Lane Room 2131A Rockville, MD 20857 Natalie.Mitchell@fda.hhs.gov 7.2. INVOICE SUBMISSION 7.2.1. In accordance with clause 52.232-33 all payments made under this contract shall be made using electronic funds transfer through the Automated Clearing House (ACH). The Contractor shall provide the following information to the Food and Drug Administration no later than 14 days prior to submission of the first invoice: A. The contractor shall submit all invoices to all addresses in the manner specified below: (I) One original to the Contracting Officer: U.S. Food and Drug Administration Office of Acquisitions and Grants Services ATTN: Natalie Mitchell 5630 Fishers Lane Room, HFA-500 Rockville, MD 20857 E-mail: Natalie.Mitchell@fda.hhs.gov *** Acceptable methods of delivery include: mail, hand delivery and email*** (II) One copy to the contracting officer representative (COR), clearly marked "Courtesy Copy Only": U.S. Food and Drug Administration/Center for Tobacco Products ATTN: Stephanie Durkin, COR 9200 Corporate BLVD Rockville, MD 20850 Email: Stephanie.Durkin@fda.hhs.gov *** Acceptable methods of delivery include: mail, hand delivery and email*** B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt payment) AND 52.232-33 (Payment by electronic funds transfer - Central Contractor Registration) and/or other applicable FAR clauses specified herein. 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, unit price, and extended price supplies delivered or services performed, including: (a) Period of performance for high costs claimed; (b) Itemized travel costs, including origin and destination; (c) 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 to 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 the person to notify in the event of a 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), as referenced on the purchase order; (XII) Any other information or documentation required by the purchase order/award. (XIII) Contractor is □ is not □ required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes: (a) List of all invoices submitted to date under the subject award, including the following: (1) Invoice number, amount, and date submitted (2) Corresponding payment amount and date received (b) Total amount of all payments received to date under the subject contract or order (c) And, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance. C. An electronic invoice is acceptable if in Adobe Acrobat (PDF) format. All items listed in (I) through (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: Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments 301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov 7.2.2. Final payments will occur upon verification by the FDA COR, noting acceptance of the work. 7.2.3. Payment will be made after acceptance and receipt of a proper invoice, and in accordance with the pricing matrix described in Pricing Terms. 7.2.3.1. Payment will be made in accordance with the pricing matrix. 7.3. PERIOD OF PERFORMANCE 7.3.1. The period of performance for this contract shall be from the date of award to 90 days following the date of award with fulfillment of delivery to NIST. 7.4. PLACE OF PERFORMANCE 7.4.1. The place of performance for this contract shall be at the contractor's site. PART 8 - CONTRACT CLAUSES 8. FAR CLAUSES INCORPORATED BY REFERENCE 8.1. 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: www.acquisition.gov/far/index.html 52.212-4 Contract Terms and Conditions-Commercial Items (Feb 2012) 52.216-24, Limitation of Government Liability (Apr 1984) 52.227-14, Rights in Data-General (Dec 2007) 52.227-16, Additional Data Requirements (June 1987) 52.227-17, Rights in Data-Special Works (Dec 2007) 52.227-18, Rights in Data-Existing Works (Dec 2007) 52.233-2, Service of Protest (Sep 2006) 52.245-1, Government Property (Apr 2012) 52.246-4, Inspection of Services-Fixed-Price (Aug 1996) 8.2. FAR CLAUSES BY FULL TEXT 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (JAN 2013). (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: __ (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 (Jul 2010) (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). __ (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). (Applies to contracts over $30,000). (Not applicable to subcontracts for the acquisition of commercially available off-the-shelf items). __ (7) 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). __ (8) 52.219-3, Notice of Total HUBZone Set-Aside or Sole-Source Award (Jan 2011) (15 U.S.C. 657a). __ (9) 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). __ (10) [Reserved] _ (11)(i) 52.219-6, Notice of Total Small Business Set-Aside (June 2003) (15 U.S.C. 644). __ (ii) Alternate I (Oct 1995) of 52.219-6. __ (iii) Alternate II (Mar 2004) of 52.219-6. __ (12)(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. __ (13) 52.219-8, Utilization of Small Business Concerns (April 2012) (15 U.S.C. 637(d)(2) and (3)). __ (14)(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. __ (15) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a)(14)). __ (16) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). __ (17)(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. __ (18) 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). __ (19) 52.219-26, Small Disadvantaged Business Participation Program- Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). _¬_ (20) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) (15 U.S.C. 657 f). __ (21) 52.219-28, Post Award Small Business Program Re-representation (Apr 2009) (15 U.S.C. 632(a)(2)). __ (22) 52.219-29 Notice of Total Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Apr 2012). __ (23) 52.219-30 Notice of Total Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Apr 2012). _X (24) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _X (25) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (March 2012) (E.O. 13126). _X (26) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). _X (27) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _X (28) 52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212). _X (29) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). _X (30) 52.222-37, Employment Reports on Veterans (SEP 2010) (38 U.S.C. 4212). _X (31) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). _X (32) 52.222-54, Employment Eligibility Verification (JULY 2012). (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.) __ (33)(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.) __ (34) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b). __ (35)(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. _X (36) 52.223-18, Contractor Policy to Ban Text Messaging While Driving (AUGUST 2011) (E.O. 13513). _X (37) 52.225-1, Buy American Act-Supplies (Feb 2009) (41 U.S.C. 10a-10d). __ (38)(i) 52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act (May 2012) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, and 110-138). __ (ii) Alternate I (Jan 2004) of 52.225-3. __ (iii) Alternate II (Jan 2004) of 52.225-3. __ (39) 52.225-5, Trade Agreements (AUG 2009) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). __ (40) 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). __ (41) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (42) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). __ (43) 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)). __ (44) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). _X (45) 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). __ (46) 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332). __ (47) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332). __ (48) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (49)(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: __ (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)(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to- (i) Examine any of the Contractor's or any subcontractors' records that pertain to, and involve transactions relating to, this contract; and (ii) Interview any officer or employee regarding such transactions. (e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial items, other than- (i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and (ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (A) 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)). (B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (C) 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. (D) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (E) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212). (F) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). (G) 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. (H) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). (I) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). (J) 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.). (K) 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.). (L) 52.222-54, Employment Eligibility Verification (Jan 2009). (M) 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. (N) 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. 52.217-7-Option for Increased Quantity-Separately Priced Line Item (MAR 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor at least 30 days prior to the expiration of this contract. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree. 8.3. HHSAR CLAUSES INCORPORATED BY REFERENCE This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, 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: http://www.gpo.gov/fdsys/search/home.action. 352.202-1, Definitions (Jan 2006) 352.203-70, Anti-lobbying (Jan 2006) 352.215-70, Late proposals and revisions (Jan 2006) 352.223-70, Safety and health (Jan 2006) 352.224-70, Privacy Act (Jan 2006) 352.227-70, Publications and Publicity (Jan 2006) 352.228-7, Insurance--Liability to third persons (Dec 1991) 352.233-71, Litigation and claims (Jan 2006) 352.239-73, Electronic information and technology accessibility (Jan 2010) 352.242-70, Key Personnel (Jan 2006) 352.242-71, Tobacco-free facilities (Jan 2006) 352.242-73, Withholding of contract payments (Jan 2006) 352.242-74, Final decisions on audit findings (Apr 1984) 352.270-1, Accessibility of meetings, conferences, and seminars to persons with disabilities (Jan 2001) 352.270-4, Protection of Human Subjects (Jan 2006) 352.270-6, Restriction on use of Human Subjects (Jan 2006) PART 9 - INSTRUCTIONS TO THE OFFERORS 9.1. Response Date: 9.1.1. All quotes shall be sent via email to Natalie.Mitchell@fda.hhs.gov before 1:00 pm (1300) EASTERN TIME on August 2, 2013. 9.2. Quote Format 9.2.1. A successful technical quote shall include FOB point; a POC (name and telephone number); a statement from the offeror verifying they are registered in SAM under NAICS code 312230 and business size. 9.2.1.1. Factor 1: Technical Capability - The offeror shall demonstrate through a management plan the ability to manufacture 2,500 kilograms of tobacco filler to the specifications under table 2, with arrival at NIST 90 days after date of award. The following are important factors: • production of the most homogenous material, as judged by: • fewest types of tobacco used, • consistent cut width, • the shortest manufacturing time, • minimal number of blending operations required, • lack of additional ingredients. • oven volatiles, nicotine, and TSNA content 9.2.1.2. Factor 2: Price - The offeror shall submit a complete pricing table as indicated in Part 3 (Table 1). PART 10 - EVALUATION AWARD CRITERIA The Government shall award this contract to the lowest price technically acceptable (LPTA) quote. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer(or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.
 

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Record

SN03107215-W 20130705/130703235152-7d156ca0257a4b4c99d5b4fd978f9f65 (fbodaily.com)
 

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