SOLICITATION NOTICE
66 -- Phantoms for Evaluation of Breast Tomosynthesis
- Notice Date
- 8/16/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334517
— Irradiation Apparatus Manufacturing
- 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
- 1090237
- Archive Date
- 9/6/2011
- 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 items 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. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 1090237. 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 under the authority of FAR 6.302-1. The appropriate NAICS code for this acquisition is 334517 - Irradiation Apparatus Manufacturing with a small business size standard of 500 employees The purchase order awarded as a result of this RFQ shall be firm fixed price, FOB destination. No advance payments are authorized. The Government will award a purchase order to the lowest priced technically acceptable offeror. The burden of demonstrating technical acceptability rests with the offeror. The Food and Drug Administration requires Phantoms for the Evaluation of Breast Tomosynthesis. 1. The first of the two phantom types is intended to permit quantitative measurement of the degree to which out-of-plane structures in the object being imaged appear in the plane of interest in a tomosynthesis image stack. The structure shall be of 3-dimensional small diameter (around 1 mm) rod like structures embedded in breast-tissue-equivalent material which shall have the same as the overall size and shape as existing anthropomorphic phantoms that simulate an average breast. The material surrounding the 3-D structure shall be x-ray equivalent to a mixture consisting of 25-30% glandular tissue with the remainder adipose tissue. If the material available for producing the 3-D structure does not provide reasonable contrast with this composition for the surrounding material, the composition of the surrounding material may be adjusted to provide appropriate contrast. The rod material shall be more attenuating than the surround. 2. The second of the two phantom types is intended for a study to determine experimentally the effect that reducing breast compression has on image quality in digital breast tomosynthesis. The phantom shall match approximately a "D cup" size breast, with an uncompressed thickness of 5 to 6 cm and must be compressible The degree of compressibility shall be stated. The phantom must have a non-uniform background, possibly achieved by "swirling" two materials of differing attenuation properties. The phantom shall have a variety of target types, sizes, and contrast levels, with a range of sizes such that the smallest targets provide challenging detection tasks. The targets shall be located at several levels in the phantom. Options for increased quantities shall be available in the same general design as types one and two but for item 1 with changes in contrast of the 3-D structure and/or other targets and for item 2, with changes in contrast of the background features and the targets. Both breast configurations must be in a physical configuration that would simulate the shape of a breast under compression for mammography. The period of performance will have a base period of three months, with 4 option periods for a total period of performance of 11 months. The order will also have an option for ordering increased quantities during the period of performance. The provision at FAR 52.212-3 Offer Representations and Certifications - Commercial Items, applies to this acquisition. The 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 52.214-5, 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 additional FAR clause in this clause are applicable: 52.222-50 Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104 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 (SEP 2010) (29 U.S.C. 793) 52.225-3 Buy American Act - Free Trade Agreements - Israeli Trade Act (JUN 2009) (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, 109-302, 109-53, 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 the Foreign Assets Control of the Department of the Treasury) 52.232-33 Payment by Electronic Funds Transfer - Central Contract 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) 52.217-6 Option for Increased Quantity (MAR 1989) The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the other by written notice to the Contractor within 30 days. Delivery of added items shall continue at the same rate as the like items called for under the contract unless the parties otherwise agrees Clauses and Provisions can be obtained by accessing http://www.acquisitions.gov. CCR Requirement - Company must be registered in the Central Contractor Registration (CCR) System before an award can be made. If company is not registered in CCR, they may do so by going to the CCR web site at http://www.ccr.gov. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable 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. An official authorized to bind the offeror must sign the terms and conditions of the offer. All responsible sources may submit an offer which if timely received, shall be considered. The offer must reference number solicitation 1090237. The RFQ is due in person, by postal mail, fax or email to the point of contact listed below on or before close of business on August 24, 2011, in Jefferson, AR 72079-9502. Questions regarding this posting shall be submitted via email no later than 1:00 P.M. CDT on August 22, 2011. For information regarding this RFQ, please contact Marcia Park at 870/543-7405 voice, 870/543-7990 fax or email to marcia.park@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1090237/listing.html)
- Place of Performance
- Address: White Oak Campus, Bldg 62, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02536910-W 20110818/110817000401-32d8be3c48eb2c01b79da5dc160e45c0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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