SOLICITATION NOTICE
66 -- MDI Actuation
- Notice Date
- 6/25/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1075413
- Archive Date
- 7/27/2010
- Point of Contact
- WIKIKI HENTON, Phone: 4042531252
- E-Mail Address
-
wikiki.henton@fda.hhs.gov
(wikiki.henton@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- THIS REQUIREMENT IS SUBJECT TO THE AVAILABILITY OF FUNDS This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Part 12.6 Streamlined Procedures for Evaluation and Solicitation for Commercial Items and issued in accordance with FAR 13 - Simplified Acquisition Procedures. This announcement constitutes the only solicitation; quotations are being requested, and a separate written solicitation document will not be issued. The North American Industrial Classification Code System (NAICS) for this procurement is 334516 with a business size standard of 500 employees. Background: The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs." Objective: CDER needs to acquire an instrument capable of automatically delivering consistent and controllable MDI actuations, providing a "shaking" function, and having the capability to connect with an Anderson cascade impactor and a Next Generation Impactor. Line Item 0001: Quantity one (1) each MDI Actuation collection station with shaking function including docing platform waste port accommodating USP throat for collection into ACI NGI meeting or exceeding all of the minimum Technical Requirements listed in this solicitation. Line Item 0002 (Option Year): Quantity one (1) each Extended Warranty meeting or exceeding all of the minimum Technical Requirements listed in this solicitation. Performance will be for a one year period. Period of Performance: To be determined based Line Item 0003 (Option Year): Quantity one (1) each Extended Warranty meeting or exceeding all of the minimum Technical Requirements listed in this solicitation. Performance will be for a one year period. Period of Performance: To be determined based Line Item 0004 (Option Year): Quantity one (1) each Extended Warranty meeting or exceeding all of the minimum Technical Requirements listed in this solicitation. Performance will be for a one year period. Period of Performance: To be determined based Technical Requirements: Performance Specifications: 1. Must provide consistent, computer controlled automated mechanical MDI actuations. 2. Must provide consistent, computer "shaking" function between MDI actuations. 3. Must provide a waste port with provision to safely collect waste actuations. 4. Must provide a connection to USP throat for collection of aerosol into Andersen cascade impactor and Next Generation Impactor. 5. Must provide the software to characterize, design, and control MDI actuations including a shaking function. 6. Software must document all parameters and provide audit trail with time stamp. Software must be preloaded on vendor-supplied computer. Trade and Service Specifications: 1. The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of this instrument is intended to be greater than ten (10) years at full performance. CDER must be able to reasonable expect service and technical support from the vendor during its lifecycle. 2. The entire system must be warranted for parts and labor for 12 months from the date of installation. The vendor shall provide a copy and pricing for any available extended warranties and service contracts. The vendor must also be capable of servicing the instrument through the extended warranty or service contract. The information shall not obligate CDER to purchase and extended warranty. The vendor must demonstrate the ability to manufacture the instrument system with a high degree of quality control as evidenced by units in use by other customers performing applications with similar technical demands. ALL QUOTES SUBMITTED SHALL BE VAILD FOR NOT LESS THAN 90 DAYS. Delivery: Delivery shall be FOB Destination. FDA shall not be responsible for any transit liability. Final Acceptance: Final Acceptance shall be provided and payment in full shall be made upon receipt and acceptance of all Line Items. PROVISIONS AND CLAUSES 52.252-2 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 FAR provision or clause may be accessed electronically at www.acqnet.gov/far. The following FAR provisions apply to this acquisition: 52.212-1 - Instructions to Offerors - Commercial; and 52.212-3 - Offeror Representations and Certifications - Commercial Items. In accordance with FAR 52.212-3 Offeror Representations and Certifications - Commercial Items, offerors must complete annual representations and certifications on-line at http://orca.bpn.gov. If paragraph (j) of the provision applies, a written submission is required; The following FAR clauses apply to this acquisition: 1) 52.212-4 - Contract Terms and Conditions (Commercial Items); 2) 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders (Commercial Items including subparagraphs); 3) 52.222-3 - Convict Labor; 4) 52.222-19 - Child Labor (Cooperation with Authorities and Remedies); 5) 52.222-21 - Prohibition of Segregated Facilities; 6) 52.222-26 - Equal Opportunity; 7) 52.222-36 - Affirmative Action for Workers with Disabilities; 8) 52.225-1 - Buy American Act-Supplies; 9) 52.225-13 - Restriction on Certain Foreign Purchases (E.O. 12722, 12724, 13059, 13067, 13121, and 13129); 52.232-33 - Payment by Electronic Funds Transfer (Central Contractor Registration); 52.217-8 - Option to Extend Services (Nov 1999); 52.217-9 - Option to Extend the Term of the Contract (Mar 2000). 52.232-18 - Availability of Funds (Apr 1984) 52.232-19 - Availability of Funds for the Next Fiscal Year (Apr 1984) Technical Evaluation and Award Criteria: Technical Evaluation: Quotes should explain why and how their instrument meets or exceeds each detailed technical requirement, and include supportive data and descriptions wherever possible. The detailed responses will be sorted into the follow factors, as appropriate, and a composite score awarded for each factor. The highest point total is the preferred instrument. Factors and Points (out of 100) Technical specifications: 60% of the total points awarded will be related to the degree to which the vendor meets or exceeds the detailed technical specifications. Emphasis will be placed on the delivery of consistent and controllable MDI actuations, and the "shaking" function. Service capability: 20% of the total points warded will be related to the ability of the vendor to provide technical support and service for the instrument over the next 3 years. This factor can be met by demonstrating that the vendor's service department has been adequately staffed in previous years or by customer endorsements or by other methods. Suitable for intended purpose: 10% of the total points awarded will be related to the ability of the vendor to demonstrate that their instrument has been used successfully by the pharmaceutical industry to deliver automated MDI actuations for applications with similar technical demands. User friendliness: 10% of the total points awarded will be related to the ease of use of the instrument and software. This will include factors related to the ability of the user to export data and images to other programs including Microsoft Office products. Award: Award will be made on technically-acceptable, lowest-price basis. Technically -acceptable refers to meeting or exceeding the technical specifications delineated in this Solicitation and acceptable to the End User. Price shall not be evaluated on quotes that are determined not to be technically-acceptable.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1075413/listing.html)
- Place of Performance
- Address: Food and Drug Administration, 1114 Market St. Room 1002, St Louis, Missouri, 63101, United States
- Zip Code: 63101
- Zip Code: 63101
- Record
- SN02189124-W 20100627/100625235405-c22299173ebca0d128f3ac3686022bde (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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