Loren Data's SAM Daily™

FBO DAILY ISSUE OF SEPTEMBER 04, 2008 FBO #2474
DOCUMENT

A -- Safety and Potency Testing - Statement of Work - Sample Protocol

Notice Date

9/2/2008
 

Notice Type

Sample Protocol
 

NAICS

541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 

Contracting Office

Other Defense Agencies, Uniformed Services University of the Health Sciences, Directorate of Contracting, 4301 Jones Bridge Road, Bethesda, Maryland, 20814-4799
 

ZIP Code

20814-4799
 

Solicitation Number

PMB8022
 

Response Due

9/12/2008
 

Archive Date

9/13/2008
 

Point of Contact

Michelle Creenan,, Phone: 301-295-3924
 

E-Mail Address

micreenan@usuhs.mil
 

Small Business Set-Aside

Total Small Business
 

Description

The Uniformed Services University of the Health Sciences (USU), located on the National Naval Medical Campus (NNMC) in Bethesda, MD, has a requirement for the safety and potency testing of mycobacterial elicitins prepared for determination of human bioequivalent doses. This is a combined synopsis/solicitation prepared in accordance with FAR Part 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested. This is a request for quotes (RFQ) for commercial items in accordance with FAR Part 12-Acquisition of Commercial Items and FAR Part 13-Simplified Acquisition Procedures. This RFQ incorporates all provisions and clauses in effect through Federal Acquisition Circular 05-26. Quotes are due September 12, 2008 and may be emailed to micreenan@usuhs.mil or faxed to 301.295.1716. Offerors who mail in their quotes must ensure their quote is received to the following address by September 12 th : USUHS Attn: Michelle Creenan RFQ: PMB8022 4301 Jones Bridge Road Room: A1040C Bethesda, MD 20814 USU is located on a secure installation. Offerors who hand deliver their quotes must find their own means of gaining access to the installation. There will not be anyone available to meet any offeror at the gate to accept their quote. The applicable NAICS code is 541712-Research and Development in the Physical, Engineering and Life Sciences (except Biotechnology) with a size standard of 500 employees. This requirement is set aside for small businesses. Attachments: Statement of Work Sample Protocol for Animal Safety and Potency Tests for PPD Dilutions Evaluation Factors: The resultant award will be a firm-fixed-price contract. The basis of award shall be made in the best interest of the government based on the following evaluation factors. A single award will be made to the offeror whose quote displays a clear understanding of the requirement and represents the best value to the government. The government reserves the right to award without discussions. Corporate Experience/Technical Capability: Offerors must provide a narrative of similar safety (per FDA regulations) and potency (per FDA regulations) study done using animals, performed under Good Laboratory Practices (GLP). Offerors must also demonstrate their understanding of statement of work, by including in their quote the steps completed by their lab for testing the mycobacterial elicitines, any issues that could be encountered and the estimated performance period of the project. Past Performance: Offerors must submit three (3) customer references who they provided similar services to within the past three (3) years. The following information must be included for each reference: •· Government Agency/Business Name •· Address •· Name, phone number and email address for point of contact •· Contract Number (if applicable) •· Contract Amount •· Performance Period •· Brief Description of Services •· Description of any issues that arose during performance of the contract. Any offeror who does not provide three customer references will be considered nonconforming to the requirements of the RFQ, unless a statement is included in the quote that the offeror has not provided services to three customers within the past three years. Offerors will have any opportunity to address any adverse past performance history. Offerors who do not have any past performance history will not be rated favorably or unfavorably, but will instead receive a neutral/unknown rating for past performance. The government reserves the right to use data provided by the offeror and data provided by alternative sources in conducting its assessment of past performance history. Price: Offerors are to provide a firm fixed price for the project. Include the pricing detail for the following: Number of mice and unit cost Number of guinea pigs and unit cost Number of cages and unit cost Estimated amount of food and bedding and unit cost Different labor categories and loaded labor rates (included estimated number of hours for each labor category) Any additional costs Offerors must provide a completed copy of 52.212-3-Offeror Representation and Certification-Commercial Items. USU requires all contractors, supplying live laboratory animals, their tissues, fluids and other related products to be in full compliance with all federal, state and local laws and guidelines that govern the care and use of laboratory animals. USU reserves the right to site visit the contractor's laboratory animal facility to evaluate their animal care and use program for compliance. The cover page of the quote should include the company name, RFQ number, point of contact (including telephone number and email address), TIN and DUNS. Question Submittal: All questions regarding this requirement must be emailed to micreenan@usuhs.mil by September 5th. Questions submitted after September 5 th will not be answered. Questions will not be answered over the phone. All questions and answers will be posted as an amendment to the solicitation on or about September 9th. Provisions & Clauses: 52.252-1 Solicitation Provisions Incorporated by Reference. 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.acqnet.gov/far/index.html _____________________________________________ _____________________________________________ [ Insert one or more Internet addresses ] 52.212-1-Instructions to Offerors-Commercial Items 52.232-3-Offerors Representation and Certification-Commercial Items 52.212-2 Evaluation-Commercial Items. As prescribed in 12.301 (c), the Contracting Officer may insert a provision substantially as follows: Evaluation-Commercial Items (Jan 1999) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: •· Corporate Experience/Technical Capability •· Past Performance •· Price (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) 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. 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://acqnet.gov/far/index.html _____________________________________________ _____________________________________________ 52.212-4-Contract Terms and Conditions-Commercial Items 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 (June 2008) (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) 52.233-3, Protest After Award ( Aug 1996) ( 31 U.S.C. 3553 ). (2) 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.] __ (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 ). __ (2) 52.219-3, Notice of Total HUBZone Set-Aside (Jan 1999) ( 15 U.S.C. 657a ). __ (3) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns ( July 2005) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a ). __ (4) [Reserved] _X_ (5)(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. __ (6)(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. __ (7) 52.219-8, Utilization of Small Business Concerns (May 2004) ( 15 U.S.C. 637(d)(2) and (3)). __ (8)(i) 52.219-9, Small Business Subcontracting Plan (Apr 2008) ( 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. __ (9) 52.219-14, Limitations on Subcontracting (Dec 1996) ( 15 U.S.C. 637(a)(14) ). __ (10) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) ( 15 U.S.C. 637(d)(4)(F)(i) ). __ (11)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns ( Sept 2005 ) ( 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. __ (12) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Apr 2008) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323 ). __ (13) 52.219-26, Small Disadvantaged Business Participation Program-Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323 ). __ (14) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) ( 15 U.S.C. 657 f ). _X_ (15) 52.219-28, Post Award Small Business Program Rerepresentation (June 2007) ( 15 U.S.C. 632(a)(2) ). _X_ (16) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _X_ (17) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2008) (E.O. 13126). _X_ (18) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). _X_ (19) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). __ (20) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) ( 38 U.S.C. 4212 ). _X_ (21) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) ( 29 U.S.C. 793 ). __ (22) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) ( 38 U.S.C. 4212 ). __ (23) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201). _X_ (24)(i) 52.222-50, Combating Trafficking in Persons (Aug 2007) (Applies to all contracts). __ (ii) Alternate I (Aug 2007) of 52.222-50. __ (25)(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) ). __ (ii) Alternate I (May 2008) of 52.223-9 ( 42 U.S.C. 6962(i)(2)(C) ). __ (26) 52.223-15, Energy Efficiency in Energy-Consuming Products ( Dec 2007 ) ( 42 U.S.C. 8259b ). __ (27)(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. __ (28) 52.225-1, Buy American Act-Supplies (June 2003) ( 41 U.S.C. 10a-10d ). _X_ (29)(i) 52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act (Aug 2007) ( 41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, Pub. L 108-77, 108-78, 108-286, 109-53 and 109-169). __ (ii) Alternate I (Jan 2004) of 52.225-3. __ (iii) Alternate II (Jan 2004) of 52.225-3. __ (30) 52.225-5, Trade Agreements ( Nov 2007 ) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X_ (31) 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). __ (32) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) ( 42 U.S.C. 5150 ). __ (33) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) ( 42 U.S.C. 5150 ). __ (34) 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) ). __ (35) 52.232-30, Installment Payments for Commercial Items (Oct 1995) ( 41 U.S.C. 255(f), 10 U.S.C. 2307(f) ). _X_ (36) 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003) ( 31 U.S.C. 3332 ). __ (37) 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (May 1999) ( 31 U.S.C. 3332 ). __ (38) 52.232-36, Payment by Third Party (May 1999) ( 31 U.S.C. 3332 ). __ (39) 52.239-1, Privacy or Security Safeguards (Aug 1996) ( 5 U.S.C. 552a ). __ (40)(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) (Nov 2006) ( 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 (Feb 2002) ( 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 U.S.C. 351, et seq. ). __ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Nov 2007) ( 41 U.S.C. 351, et seq. ). __ (7) 52.237-11, Accepting and Dispensing of $1 Coin (Aug 2007) ( 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 paragraphs (i) through (vii) of this paragraph in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i) 52.219-8, Utilization of Small Business Concerns (May 2004) ( 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 $550,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (ii) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (iii) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) ( 38 U.S.C. 4212 ). (iv) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) ( 29 U.S.C. 793 ). (v) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201). (vi) 52.222-41, Service Contract Act of 1965 (Nov 2007) ( 41 U.S.C. 351, et seq.). (vii) 52.222-50, Combating Trafficking in Persons (Aug 2007) ( 22 U.S.C. 7104(g) ). Flow down required in accordance with paragraph (f) of FAR clause 52.222-50. (viii) 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. ). (ix) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Nov 2007) ( 41 U.S.C. 351, et seq. ). (x) 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.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=b0d489d166dbc349881f00d5ba67eb30&tab=core&_cview=1)
 

Document(s)

Sample Protocol
 

File Name: Statement of Work for Animal Testing of IND Product (RFQ-PMB8022.doc)

Link: https://www.fbo.gov//utils/view?id=283b812c02265f52d0251f2a73d9dc9f

Bytes: 114.50 Kb
 

File Name: Protocol: Animal Safety and Potency Tests for PPD Dilutions (Protocol-Animal Safety and Testing.pdf)

Link: https://www.fbo.gov//utils/view?id=e094ea2579f883ea092cce7162872fdc

Bytes: 5,819.23 Kb
 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: 4301 Jones Bridge Road, Bethesda, Maryland, 20720, United States

Zip Code: 20720
 

Record

SN01657006-W 20080904/080902220816-b0d489d166dbc349881f00d5ba67eb30 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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