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R -- Technical Assistance

Notice Date
Notice Type
541690 — Other Scientific and Technical Consulting Services
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
Solicitation Number
Archive Date
Point of Contact
David - Kordel,
E-Mail Address
Small Business Set-Aside
Total Small Business
Subject: Technical Assistance Solicitation Number: FDA1058900 Response Date: 24 July 2009 DESCRIPTION: THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-33. The associated North American Industrial Classification System (NAICS) code for this procurement is 541690 for a 100% small business set-aside. Statement of Work 1.1 Background FDA regulates intraocular lens (IOL) implants and optical radiating emitting diagnostic and therapeutic medical devices. This includes ophthalmic instruments and surgical refractive devices as well as fluorescence and imaging devices. In the last decade, optical radiation emitting medical devices using new light sources and new optical therapeutic devices are being developed at a rapid and accelerating rate. These rapidly developing technologies require careful research to evaluate the safety and efficacy of these new devices prior to clearance for marketing. 1.2 Objective The purpose of this requirement is to ensure the availability of consultation services for the review of documents (IDE, 510k, PMA) submitted to the FDA, and design and development of test methods for optical medical device in coordination with national and international consensus standards organizations. 1.3 Project Scope This requirement shall provide services to CDRH’s Optical Therapeutics and Medical Nanophotonics Laboratory in all phases of safety, optical quality, and optical radiation testing of medical devices. 2.0 Description of Work The Contractor shall: a. Have a working knowledge of the following documents: --IEC 62471: Photobiological safety of lamps and lamp systems --ISO 15004-2: Ophthalmic instruments - Fundamental requirements and test methods, Part 2: Light Hazard Protection --ISO/DIS 15752.2 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety --ANSI / IESNA RP-27.1:2005, Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements --ANSI / IESNA RP-27.2:2000, Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques --ANSI / IESNA RP-27.3:2007, Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Risk Group Classification and Labeling --International Commission on Non Ionizing Radiation Protection (ICNIRP) guidelines b. Have experience testing optical medical devices, such as: IOLs Transilluminators Sunlamps c. Contractor shall provide technical consultation and laboratory support to staff of the Division of Physics as needed on issues of phototoxicity for 510(k), IDE, and PMA submissions. d. Contractor shall provide technical consultation and laboratory support to staff of the Division of Physics as needed on the development of national and international performance standards for optical radiation emitting medical devices. e. Contractor shall provide technical consultation and laboratory support as needed for the development of measurement protocols and standard test methods to evaluate the optical quality of intraocular lens implants (IOL) implants and recently developed IOL designs. This includes standard test methods to evaluate the potential for temporary/permanent glare and unwanted images resulting from IOL, and to characterize IOL optical scattering properties depending on the size, geometrical shape and distribution of glistenings in IOLs. The work shall include design and assembly of laboratory setup for simulating and testing glare and unwanted images. The results obtained shall be further used for publications and development of new guidance/standard documents. f. Contractor shall provide technical consultation and laboratory support as needed for evaluating potential hazards that may be associated with optical radiation emitting medical devices. g. Contractor shall preparation of scientific papers, reviews, and reports as needed to document the vendor’s activities in support of the Division of Physics. Coordinating Instructions a. All work shall be performed on an as needed basis as determined by the CDRH/OSEL/Division of Physics. The Division of Physics will contact the contractor and arrange a mutually agreeable schedule. b. With the exception of documentation, all tasks shall be performed at facilities located in Silver Spring, MD 20993. Documentation may, with the approval of the Project Officer, be performed at the contractor’s facility. 3.0 Task Deliverables and Milestones: Deliverables Task Due Date -Laboratory procedures. Prepare reports of laboratory procedures for optical medical device tests developed under this requirement. 30 days after completion of task. -Laboratory test results. Compile data from laboratory tests performed under the terms of this requirement. 30 days after completion of task. -Laboratory test reports. When required, analyze data from laboratory tests performed under the terms of this requirement. Within 10 business days from completion of laboratory tests. -Scientific papers. When required, prepare scientific papers for publication based on laboratory work accomplished. Within 60 business days from completion of laboratory tests. Criteria for Acceptance Only the Project Officer that initiated the tasking or designated manager has the authority to accept or reject deliverables. The acceptance of deliverables and satisfactory work performance required herein shall be based upon the timeliness, accuracy and suitability of the deliverable. The specific deliverables and schedule for delivery shall be as agreed upon and documented. All data and documents are to be submitted solely in electronic form and in the native file format of MS Word, MS Excel, or MS Power Point. Raw scientific data from laboratory tests should be compiled and submitted in the format generated by the laboratory instrument used to acquire the data. Deliverables shall be submitted to the FDA. Materials and resources to be supplied by FDA: FDA will supply the laboratory facilities, instruments, test items, and expendables necessary to perform the tasks required under the terms of the requirement. In addition, if needed, office space, printing capability, telephone, and office supplies will be supplied. FDA can and will utilize the requirement by contacting the contractor project manager and informing him/her of the nature of the need and services required. The contractor(s) shall schedule work Monday through Friday on site in Silver Spring, MD 20993 between the hours of 0700 and 1900, excluding federal holidays, not to exceed a total of 250 per year. 4.0 Location, Work Schedule and Travel Unless otherwise directed, contractors will adhere to standard work hours, working no more than 40 hours per week and observe all U.S. Government holidays. 5.0 Security and Privacy It is not anticipated that the contractor will be exposed to sensitive Agency information or data. But, the contractor agrees that contractor personnel will not divulge or release information or data developed or obtained in connection with performance of this requirement, unless made public by FDA or upon written approval by the Project Officer. 6.0 Contractor Conformance with Applicable Laws, Regulations, Policies and Standards The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies and standards at the government-wide, HHS and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST) and Government Accountability Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov. 7.0 Payment Terms & Period of Performance Payment shall be on an as invoiced basis with a brief report of work completed under that invoice. The maximum payment per year shall not exceed 250 hours. A resume is required for the position which measures the qualifications and experience of the proposed contractor detailed in the requirement. A “man year” equates to 1880 hours. One resume is to be provided for the combined labor category as follows: Engineering (Occupation Code 11-9041) A total of one (1) resume shall be included with your proposal for evaluation. Resumes shall not be submitted for the labor categories containing zero hours. Personnel proposed by the offeror will be evaluated for their formal education/training, technical skills and years of experience against the desired qualifications set forth below. All resumes shall be weighted equally for evaluation purposes. Resumes that meet the desired qualifications will be scored in the acceptable range, while those that exceed the desired requirements of education and/or experience will be scored higher." For instance, if the requirement is for a Bachelor's degree and the proposed person has a Masters degree they would receive extra credit (i.e. Acceptable versus Exceptional). The resumes will be scored against the following criteria: 1. Formal Education and/or training. 2. General Experience. 3. Specialized Experience. 4. Previous work experience clearly indicates skill and ability to perform in the labor category for which he/she is being proposed. A price breakdown should be submitted in the following format for evaluation: Base Year: I. Fully Burdened Hourly Rate Item description: a. Consultant - Other Scientific and Technical Consulting Services: 250 hours at a rate of $____ per hour = $______ or $______/month or __ hours/month Total Fully Burdened Hourly labor costs = $_______ ($_______/month or ____ hours/month) Option Year 1: Total Fully Burdened Hourly labor costs (250 hours) $______ Option Year 2: Total Fully Burdened Hourly labor costs (250 hours) $______ Option Year 3: Total Fully Burdened Hourly labor costs (250 hours) $______ Option Year 4: Total Fully Burdened Hourly labor costs (250 hours) $______ Period of Performance: Base year and 4 option years. QUESTIONS DEADLINE: all questions must be received by email (david.kordel@fda.hhs.gov) before 4:30 pm (1630) EST on 16 July 2009. Delivery terms shall be FOB Destination. FOB Destination means the contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. The Government will evaluate offers for award purposes by adding the base price plus all options to arrive to the total price for the requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise an option line item. Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to "Meet or Exceed the Requirement," 2) Past Performance and 3) Price. Technical Capability and Past Performance when combined is significantly more important than price. Evaluation of Technical Capability shall be based on the requirements provided in the quotation. Offerors shall include their understanding of the requirement, technical approach and past performance that can clearly support your quote. The contractor shall demonstrate past experience directly relevant to the types of work needed. Such experience includes projects performed in the past five years similar in scope to the requirements of this Statement of Work. FAR provisions can be found on the following website: http://www.arnet.gov. The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.212-4 Contract Terms and Conditions Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items; 52.217-5 Evaluation of Options; 52.217-8 Option to Extend Services; 52.217-9 Option to Extend the Term of the Contract; 52.219-6 Notice of Small Business Set-Aside; Commercial Items including subparagraphs: 52.222-3, Convict Labor 52.222-6 Davis-Bacon Act 52.222-7 Withholding of Funds 52.222-8 Payrolls and Basic Records 52.222-12 Contract Termination-Debarment 52.222-13 Compliance with Davis-Bacon and Related Act Regulations 52.222-26 Equal Opportunity 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act—Supplies; 52.225-2 Buy American Certificate; 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. 52.243-3, Changes—Time-and-Materials or Labor Hours The Government intends to award a labor hour contract as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 541690; delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA, Silver Spring, MD 20993. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 4:30 PM (1630) EST on 24 July 2009 to the attention of David Kordel, david.kordel@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.
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