SOLICITATION NOTICE
65 -- SophonoTM Alpha 2 MPO Magnetic Implant
- Notice Date
- 6/5/2018
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Department of the Army, U.S. Army Medical Command, MEDCOM, North Atlantic Regional Contracting Office, 8901 Rockville Pike, Bldg 54, Bethesda, Maryland, 20889, United States
- ZIP Code
- 20889
- Solicitation Number
- W91YTZ18Q0122
- Archive Date
- 6/23/2018
- Point of Contact
- Deneith Graves, Phone: 7067872211, ,
- E-Mail Address
-
deneith.graves.civ@mail.mil,
(deneith.graves.civ@mail.mil, /div)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, 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. Solicitation number W91YTZ-17-Q-0122 is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-92 and Defense Federal Acquisition Supplement Publication (DPN) 20161104. This acquisition is issued on an UNRESTRICTED basis under NAICS code 339113 and size standard is 750. The Government anticipates awarding a single award issued as Firm Fixed Price. The requirement of this solicitation is to provide a SophonoTM Alpha 2 MPO Magnetic Implant at Winn Army Medical Community Hospital, Fort Stewart, GA. Quotes are due by 8 June 2018 at 12:00 pm EST. Questions must be submitted via email no later than 7 June 2018. Quotes and questions shall be submitted via email to deneith.graves.civ@mail.mil. ITEM NO. 0001 SophonoTM Alpha 2 MPO Magnetic Implant, magnetic device implants and instrumentation or equivalent, with vendor representative in attendance during patient specific surgery scheduled for 29 June 2018. Patient suffers from a congenital absence atresia and stricture of the auditory canal. The SophonoTM Alpha 2 MPO Magnetic Implant must be magnetic bone conduction hearing system brings abutment-free bone conduction to patients with the smallest magnetic implant on the market. The implant lies completely under skin and has low risk of skin issues. After healing, the skin and hair look normal, with no titanium abutment protruding through the skin like other bone conduction systems. The implant consists of two magnets hermetically sealed in a titanium case. An Attract magnetic spacer (connected to the external processor) is held in position by the magnetic implant. The processor transmits audio vibrations through the skin into the bone where sound is sensed by the cochlea. The Sophono is FDA cleared for MRI conditional up to 3 Tesla. SUBSTITUTE ITEMS: If you plan to provide other than the brand name cited in the purchase description, provide in your response the brand name and the catalog or part number you intend to furnish and the characteristics of the substitute item that are equivalent to the brand name. Also provide all documents which clearly describe the item(s) so that it/they can be evaluated by the end user. Failure to submit the requested substitute item information before the closing date listed above will eliminate the vendor from all further consideration. Items otherwise equal may not satisfy the requirement due to differences in material composition, size, environmental application, etc. If an item is furnished which does not meet the requirement the item will be returned at the vendor's expense for a full refund. QTY: 1 UNIT: EACH UNIT PRICE: ___________ TOTAL: _______ TOTAL:_________________ Delivery Address Eisenhower Army Medical Center Building 300 East Hospital Road Fort Gordon, GA 30905 SOLICITATION PROVISIONS 52.212-1 -- INSTRUCTIONS TO OFFERORS -- COMMERCIAL ITEMS (APR 2014) Addendum to 52.212-1 (Local Provision (LP) 5004) Para (b) Submission of Offers: The following supplements this paragraph with respect to the information and documents required for submission in response to this solicitation. All responsible offerors must submit: - Technical Description of items being offered (see note) - Clin/Item Number Pricing (filled out) - Company's Dunn and Bradstreet number (DUNS) - CAGE code - Delivery Time - Company Contact Information, for evaluation purposes. - Fill out and return 52.212-3 Alt I (Registration in SAM can be substituted for FAR 52.212-3 Alt I. The information in SAM must be current and complete before an award can be made. Contractor shall not have any Active Exclusion Record in SAM. NOTE: If providing an "equal" item(s), comply with FAR Provision 52.211-6, Brand Name or Equal. Explain in detail how the proposed items will meet the salient characteristics of the items as specified here in the solicitation. Offerors shall demonstrate that the product proposed complies with the technical requirements described in the salient characteristics via the submission of a written capability statement, product literature, or other materials, with their offer. Offerors shall cross-reference their product to its "equal" in the solicitation via the use of part numbers or another methodology that clearly identifies what the submitted product is "equal" to. Offerors shall ensure their proposed quantities result in the same number of items required, as identified in the solicitation. Salient Characteristics: • Must have Abutment-Free; 4 Programs; Two microphones in an isolated compartment with omni and directional modalities. • Must have standard euro plug direct audio input; auto noise reduction; auto feedback suppression; 125-8000 Hz frequency range; 16 band, 8 channel WDRC processor. • Must be type 13 zinc air battery power supply; 115 dB peak output force level; 105 dB Output force level; up to 320 hours of battery life and audible warning tones. (m) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and MEDCOM provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 for locations where full text can be obtained. (End of Provision) 52.214-34 - SUBMISSION OF OFFERS IN THE ENGLISH LANGUAGE (APR 1991) 52.222-56 - CERTIFICATION REGARDING TRAFFICKING IN PERSONS COMPLIANCE PLAN (MAR 2015) 52.225-25 -- PROHIBITION ON ENGAGING IN SANCTIONED ACTIVITIES RELATING TO IRAN-CERTIFICATION (OCT 2015) 52.209-2 -- PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS - REPRESENTATIONS (NOV 2015) 52.209-11 - REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016) 52.209-12 - CERTIFICATION REGARDING TAX MATTERS (FEB 2016) 52.252-1 -- SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998); http://farsite.hill.af.mil/ 52.252-5 -- AUTHORIZED DEVIATIONS IN PROVISIONS (APR 1984) (Insert "DoD FAR Supplement (48 CFR Chapter 2)" in paragraph (b)) 252.203-7005 -- REPRESENTATION RELATING TO COMPENSATION OF FORMER DOD OFFICIALS (NOV 2011) 252.204-7004 - ALTERNATE A, SYSTEM FOR AWARD MANAGEMENT (FEB 2014) 252.204-7008 - COMPLIANCE WITH SAFEGUARDING COVERED DEFENSE INFORMATION CONTROLS (DEVIATION 2016-O0001)(OCT 2015) 252.204-7011 -- ALTERNATIVE LINE-ITEM STRUCTURE (SEP 2011) (See Clins) 252.215-7007 -- NOTICE OF INTENT TO RESOLICIT (JUN 2012) 252.215-7008 -- ONLY ONE OFFER (OCT 2013) 252.222-7007 - REPRESENTATION REGARDING COMBATING TRAFFICKING IN PERSONS (JAN 2015) 252.225-7050 -- DISCLOSURE OF OWNERSHIP OR CONTROL BY THE GOVERNMENT OF A COUNTRY THAT IS A STATE SPONSOR OF TERRORISM (DEC 2014) 252.247-7022 -- REPRESENTATION OF EXTENT OF TRANSPORTATION BY SEA (AUG 1992) (End of Addendum to 52.212-1) 52.212-2 -- EVALUATION -- COMMERCIAL ITEMS (OCT 2014) HCAA Local Clause 5005 (LPTA) Addendum to 52.212-2 Award will be made using the lowest price technically acceptable (LPTA) source selection process. Award will be made to the responsible offeror on the basis of the lowest evaluated price of proposals meeting or exceeding the acceptability standards for non-cost factors. Award may be made without discussions with offerors (except communications conducted for the purpose of minor clarification). Therefore, each initial offer should contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary. Paragraph (a) is hereby replaced with the following: (a) The Government will issue an order resulting from this solicitation to the responsible contractor whose quote, conforming to the solicitation, is Lowest Priced, Technically Acceptable (LPTA). Award will be on an all or none basis. (i) Price: Prices will be reviewed to determine reasonableness based on market research. (ii) Provide all requested information in Addendum 52.212-1 1. The following adjectival ratings will be used in evaluating the offeror's written technical proposal: Acceptable - Offer clearly meets the minimum requirements of the solicitation. Unacceptable - Offer does not clearly meet the minimum requirements of the solicitation. (End of Addendum to 52.212-2) 52.212-3 -- OFFEROR REPRESENTATIONS AND CERTIFICATIONS -- COMMERCIAL ITEMS (MAR 2015) ALTERNATE I (OCT 2014) CONTRACT CLAUSES 52.212-4 -- CONTRACT TERMS AND CONDITIONS -- COMMERCIAL ITEMS (MAY 2015) Addendum to 52.212-4 (Local Clause (LC) 5003 The following policy applies only if the contractor will be on the Government installation for more than thirty (30) days. (v) Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP). The contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP), 12 Nov 2013. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract. The contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals. The contractor shall require all CSPs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals. (w) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 for locations where full text can be found. Also, the full text of a clause may be accessed electronically at this/these address(es): http://farsite.hill.af.mil/ https://acquisition.gov/far/index.html 52.222-19 -- CHILD LABOR-COOPERATION WITH AUTHORITIES AND REMEDIES (JAN 2014) 52.222-50 -- COMBATING TRAFFICKING IN PERSONS (MAR 2015) 52.223-3 - HAZARDOUS MATERIAL IDENTIFICATION AND MATERIAL SAFETY DATA (JAN 1997) 52.223-5 -- POLLUTION PREVENTION AND RIGHT-TO-KNOW INFORMATION (MAY 2011) 52.223-18 -- ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT MESSAGING WHILE DRIVING (AUG 2011) 52.225-13 -- RESTRICTIONS ON CERTAIN FOREIGN PURCHASES (JUN 2008) 52.232-33 -- PAYMENT BY ELECTRONIC FUNDS TRANSFER-SYSTEM FOR AWARD MANAGEMENT (JUL 2013) 52.232-39 -- UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS (JUN 2013) 52.232-40 -- PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) 52.233-3 -- PROTEST AFTER AWARD (AUG 1996) 52.233-4 -- APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM (OCT 2004) 252.203-7000 -- REQUIREMENTS RELATING TO COMPENSATION OF FORMER DOD OFFICIALS (SEP 2011) 252.203-7002 -- REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (SEP 2013) 252.204-7003 -- CONTROL OF GOVERNMENT PERSONNEL WORK PRODUCT (APR 1992) 252.225-7048 -- EXPORT CONTROLLED ITEMS (JUN 2013) 252.232-7003 -- ELECTRONIC SUBMISSION OF PAYMENT REQUESTS AND RECEIVING REPORTS (JUN 2012) 252.232-7006 -- WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013) 252.232-7010 -- LEVIES ON CONTRACT PAYMENTS (DEC 2006) 52.209-10 -- PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS (DEC 2014) 52.219-28 -- POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (JUL 2013) 52.252-2 -- CLAUSES INCORPORATED BY REFERENCE (FEB 1998) 52.252-6 -- AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984) (Insert "DoD FAR Supplement (48 CFR Chapter 2)" in paragraph (b)) 252.203-7999 -- PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMEMNTS (DEVIATION 2015-O0010) (FEB 2015) 252.204-7012 -- SAFEGUARDING OF UNCLASSIFIED CONTROLLED TECHNICAL INFORMATION (OCT 2016) 252.204 - 7015 - DISCLOSURE OF INFORMATION TO LITIGATION SUPPORT CONTRACTORS (MAY 2016) 252.211-7003 -- ITEM UNIQUE IDENTIFICATION AND VALUATION (DEC 2013) 252.244-7000 -- SUBCONTRACTS FOR COMMERCIAL ITEMS (JUN 2013) iRAPT (LC 5002) (Formally known as WAWF) HIPPA (LC 5001) (End of Addendum to 52.212-4) 52.212-5 -- CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS -- COMMERCIAL ITEMS (OCT 2016) (DEVIATION 2013-O0019)
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA15/W91YTZ18Q0122/listing.html)
- Place of Performance
- Address: Eisenhower Army Medical Center, Building 300, East Hospital Road, Fort Gordon, Georgia, 30905, United States
- Zip Code: 30905
- Zip Code: 30905
- Record
- SN04945228-W 20180607/180605231545-8df2df32389ba718a5195d9185a69834 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |