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FBO DAILY ISSUE OF AUGUST 28, 2011 FBO #3564
SOLICITATION NOTICE

A -- Mechanical Testing of Bioabsorbable Stent Sub-Units

Notice Date

8/26/2011
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
 

ZIP Code

72079
 

Solicitation Number

1088874
 

Archive Date

9/17/2011
 

Point of Contact

Marcia O Park, Phone: (870) 543-7405
 

E-Mail Address

marcia.park@fda.hhs.gov
(marcia.park@fda.hhs.gov)
 

Small Business Set-Aside

Total Small Business
 

Description

This is a combined synopsis//solicitation for commercial services prepared in accordance with the Format in FAR Subpart 12.6 in conjunction with FAR Part 13.5, as applicable and as supplemented with additional information included in this notice. The announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 1088874. This solicitation is issued as a Request for Quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-53, dated August 4, 2011. This acquisition is set aside for small businesses. The appropriate NAICS code for this acquisition is 541990 - All Other Professional, Scientific and Technical Services with a small business size standard of $7.0 million dollars. The purchase order awarded as a result of this RFQ shall be firm fixed price. Award will be made to the lowest priced technically acceptable offeror. The Food and Drug Administration (FDA) requires a technical services contract for mechanical testing of Bioabsorbable Stent Sub-units. The service will include fatigue life or "S-N" testing, monitoring or specimen performance/survival, and additional long term fatigue testing on multiple specimens (see details below) to satisfactory completion as defined by the project tasks. The study is divided into 2 phases, S-N testing and long term fatigue testing. The following tasks will be performed following contractor receipt of FDA supplied absorbable test specimens: The first phase consists of fatigue testing of absorbable stent sub-units to identify appropriate long term testing magnitudes and cycles to failure; this testing is designated as "S-N" testing. Run-out for this testing will be 10 million cycles. This testing shall be conducted in a fluid environment at physiologic or moderately super-physiologic temperatures and accelerated test speeds both of which will be coordinated with the Contracting Officers Technical Representative (COTR) to be designated upon award. A minimum of 16 specimens will be used for this testing across multiple stress/strain amplitudes, with a minimum of 4 specimens experiencing run-out. The second phase shall consist of satisfactory completion of long term fatigue testing for 40 million cycles on a minimum of 12 successful specimens (i.e., no pre-mature specimen fractures). This testing shall occur in a fluid environment at physiologic (37 degrees C) or moderately super-physiologic temperature to be coordinated with the COTR. Accelerated test frequency may be possible, however the extent of test frequency acceleration is unlikely to exceed 3Hz and due to the viscoelastic nature of the specimen may necessitate 1 Hz testing. The following shall be required for both phases.. Routine monitoring of all experiments including temperature readings, pH reading and load and displacement verification. Frequency of monitoring shall be coordinated with the COTR.. The Contractor shall participate in teleconferences, provide a minimum of bi-weekly updates and prepare reports and presentations to FDA collaborators.. The Contractor shall complete post-fatigue actions on specimens once their testing has been completed. Post test actions shall include room temperature free swelling immersion for 24 hours followed by drying at 42 degrees C under vacuum.. The contractor shall provide technical summary reports at multiple periods during the contract. Requests for changes/additions to the reports shall be made by the FDA within 30 days of the original submission and an updated report shall be provided within 30 days after receiving FDA comments. Reports shall be submitted at the following stages: A. S-N testing completion on a minimum of 16 specimens B. Long term fatigue test setup completion using parameters (e.g., frequency, magnitude, test temperature) to be coordinated with the COTR C. Interim long term fatigue testing reports at pre-specified time intervals (such as 20 and 30 million cycles) to include raw data D. Final report when long term specimen fatigue testing has been completed (40 million cycles) to include raw data. Payments shall be made at the following testing intervals/deliverables: A. S-N testing results on bioabsorbable specimens (minimum n=16 specimens) with report. B. Complete set up of long term fatigue testing C. Interim long term fatigue testing reports at 2 distinct pre-specified endpoints (e.g., 20 and 30 million cycles) to include information on sample dimensions, weight pre- and post-test, load and displacement monitoring during testing, and other mechanical testing parameters. D. Completion of long term fatigue testing such that a minimum of 12 specimens survive testing over the course of distinct pre-specified endpoints with final report from long term fatigue testing at 3rd and final pre-specified endpoint (i.e., 40 million cycles). End of test information shall include data on sample dimensions, weight pre- and post- test, load and displacement monitoring during testing, and other mechanical testing parameters. The contractor shall be ISO 17025 certified. Responses to this combined notice shall include the company's technical approach to the Scope of Work, cost information and proof of ISO 17025 certification. The period of performance for this study will be a term of 3 years from date of award of contract. The Provision at FAR 52.212-3, Offeror Representations and Certifications - Commercial Items, applies to this acquisition. An offeror shall complete only paragraph (b) if applicable, of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The Clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to the clause. None. The Clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items. Applies to this acquisition. The following FAR clauses cited in this clause are applicable. 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 71-4(g)). 52.233.3, Protest After Award (AUG 1996) (31 U.S.C. 3553) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (PUB.L 108-77, 108-78) 52.222-21, Prohibition of Segregated Facilities (Feb 1999) 52.222-26, Equal Opportunity (MAR 2007) (E.O. 11246) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793) 52.225-3, Buy American Act -Free Trade Agreements - Israeli Trade Act (JUN 2009), Alt I (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). 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s. proclamations and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury) 52.232-33, Payment by Electronic Funds Transfer - Central Contractor Registration (Oct 2003) (31 U.S.C. 3332) 52.232-34, Payment by Electronic Funds Transfer - Other Than Central Contractor Registration (May 1999) (31 U.S.C. 3332) 52.217-5, Evaluation of Options (JUL 1990) 52.217-8, Option to Extend the Term of the Contract (MAR 2000) Clauses and Provisions may be obtained by accessing http://www.acquisitions.gov. CCR Requirement: A company must be registered in the Central Contractor Registration (CCR) System before an award can be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. The Defense Priorities and Allocations System (DPAS) and assigned rating are not application to this solicitation notice. Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation may be excluded from consideration for award. An official authorized to bind the offer must sign the terms and conditions of the offer. Questions regarding this notice must be received no later than COB August 31, 2011. All responsible sources may submit an offer which if timely received, shall be considered. The offer must reference RFQ 1088874. The offers are due in person, by postal mail, fax or email to the point of contact listed below on or before September 2, 2011 by close of business (CDT) in Jefferson, Arkansas at the Food and Drug Administration, OC/OM/OAGS, ATTN: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR 72079-9501. For information regarding this solicitation, please contact Marcia Park at 870/543-7405, FAX 870/543-7990 or email marcia.park@fda.hhs.gov.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1088874/listing.html)
 

Place of Performance

Address: FDA/CRRH, WO62, Room 2110, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States

Zip Code: 20993
 

Record

SN02552569-W 20110828/110827000739-8b5c4ff38a9eb5fcde898ab95b8935f9 (fbodaily.com)
 

Source

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

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