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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 25, 2018 FBO #5938
SPECIAL NOTICE

65 -- Avedro KXL Package - JA

Notice Date
2/23/2018
 
Notice Type
Special Notice
 
NAICS
339112 — Surgical and Medical Instrument Manufacturing
 
Contracting Office
Department of the Air Force, Direct Reporting Units, USAF Academy - 10 CONS, 8110 Industrial Drive, Suite 200, USAF Academy, Colorado, 80840-2315, United States
 
ZIP Code
80840-2315
 
Solicitation Number
FA700018T0037
 
Archive Date
3/15/2018
 
Point of Contact
Jerry B. Smith, Phone: 719338267, Brittney J. Biscone, Phone: 719-333-5599
 
E-Mail Address
jerry.smith.25@us.af.mil, brittney.biscone@us.af.mil
(jerry.smith.25@us.af.mil, brittney.biscone@us.af.mil)
 
Small Business Set-Aside
N/A
 
Description
J&A for Avedro KXL Package FEDBIZOPS NOTICE OF INTENT FOR SOLE SOURCE: The 10 CONS/PKB, Operational Contracting Office, USAF Academy, US Air Force Academy received a Sole Source justification for the purchase of an Avedro Cross-Linking Kit and KXL System Package which includes: KXL Device 110-02723 and the Avedro Cross Linking Kit 700-0001. This procurement is for the acquisition of a sole source commercial item using simplified procedures in accordance with FAR Parts 12 and 13. The requirement is in support of the 10th Medical Group at the United States Air Force Academy. The purpose of this system is to treat patients with keratoconus. The system must contain the following: - Must be able to treat keratoconus and other corneal ectasias through corneal cross- linking (CCXL). - Be approved by the FDA - Mobile - Compatible with 110/120 Voltage - Include 1 Box of Photrexa - Include 2 Boxes of Photrexa Viscous The North American Industrial Classification System (NAICS) number is 339112, Surgical and Medical Instrument Manufacturing and the business size standard is 1000. a. Only one responsible source and no other item will satisfy the Air Force requirement. b. Avedro is the only source which can provide the Avedro Cross-Linking Kit and KXL System Package because they are the sole proprietors of this system, this system is the only one approved by the FDA, and the only one available in the market for corneal cross-linking. This synopsis is for informational purposes only and does not constitute a solicitation for bids or proposals. DO NOT submit a bid/quote at this time. Any offerors believing they can provide the required equipment/medications described above may provide evidence for consideration. All specific information is included on the attached J&A. Evidence must support the offeror's claim they are authorized to sell the KXL System Package and Photrexa medications. All qualified sources may submit a response, which if timely received, will be considered by this agency. Information received will be considered solely for the purpose of determining whether a competitive procurement can be conducted. A determination not to compete this proposed procurement based on response to this notice is solely within the discretion of the Government. Responses must be received NLT 11:00 am Mountain Standard Time (MST) on 28 February 2018. The Government does not intend to pay for any information provided under this Notice of Intent. Contractors must have a current registration with the System for Award Management (SAM) at http://sam.gov/. The Government intends to award a Firm Fixed Price contract processed IAW FAR 12 and 13. Questions should be addressed to the Primary POC Britt Biscone, Contract Specialist, (719) 333-5599, brittney.biscone@us.af.mil. 5352.201-9101 OMBUDSMAN (JUN 2016) (a) An ombudsman has been appointed to hear and facilitate the resolution of concerns from offerors, potential offerors, and others for this acquisition. When requested, the ombudsman will maintain strict confidentiality as to the source of the concern. The existence of the ombudsman does not affect the authority of the program manager, contracting officer, or source selection official. Further, the ombudsman does not participate in the evaluation of proposals, the source selection process, or the adjudication of protests or formal contract disputes. The ombudsman may refer the interested party to another official who can resolve the concern. (b) Before consulting with an ombudsman, interested parties must first address their concerns, issues, disagreements, and/or recommendations to the contracting officer for resolution. Consulting an ombudsman does not alter or postpone the timelines for any other processes (e.g., agency level bid protests, GAO bid protests, requests for debriefings, employee-employer actions, contests of OMB Circular A-76 (http://www.whitehouse.gov/omb/circulars_a076_a76_incl_tech_correction/ ) competition performance decisions). (c) If resolution cannot be made by the contracting officer, the interested party may contact the ombudsman, James Anderson 8110 Industrial Drive, STE 103 USAFA, CO 80840 Telephone number 719-333-2074 FAX 719-333-9018 Email: james.anderson.72@us.af.mil Concerns, issues, disagreements, and recommendations that cannot be resolved at the Center/MAJCOM/DRU/HQ AFICA/AFISRA/SMC ombudsman level, may be brought by the interested party for further consideration to the Air Force ombudsman, Associate Deputy Assistant Secretary (ADAS) (Contracting), SAF/AQC 1060 Air Force Pentagon Washington DC 20330-1060 Telephone number 571-256-2395 FAX number 571-256-2431 (d) The ombudsman has no authority to render a decision that binds the agency. (e) Do not contact the ombudsman to request copies of the solicitation, verify offer due date, or clarify technical requirements. Such inquiries shall be directed to the Contracting Officer. (End of clause)
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/USAF/DRU/10ABWLGC/FA700018T0037/listing.html)
 
Record
SN04833376-W 20180225/180223231657-409b81481cf62fac7ffb3251bb13a543 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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