SOLICITATION NOTICE
U -- Overview of Chemometrics Training Course
- Notice Date
- 2/4/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 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
- 20857-0001
- Solicitation Number
- FDA1083907
- Archive Date
- 2/26/2011
- Point of Contact
- Emily Hunt,
- E-Mail Address
-
emily.hunt@fda.hhs.gov
(emily.hunt@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 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541690, identified as FDA1083907, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will only be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. 1. Statement of Need The intent is to purchase training from a qualified vendor on ‘Overview of Chemometrics'. With the increase in adoption of the QbD paradigm for drug development by the pharmaceutical industry, more and more new drug applications are being submitted that have employed Chemometric techniques to implement PAT (Process Analytical Technology) based methods. Typically PAT based techniques are used for process monitoring and control. The objective of this training is to provide a background on Chemometrics to ONDQA, which is imperative for the review staff to perform a thorough science and risk based evaluation of regulatory submissions containing Chemometric based models. 2. Statement of Work (SOW) The composite course should be designed to provide the student with a basic understanding of the theoretical basis of Chemometrics, with appropriate computer based hands-on experience using any Matlab based software or equivalent. In addition, when applicable, the course should also include appropriate examples of implementation of Chemometrics in the pharmaceutical industry. The student is identified as an FDA review chemist with a need to obtain greater insights into Chemometrics. The required format of the course spanning over four days, is as follows: (a) A half day course that gives a primer on Linear Algebra and software familiarity. Linear algebra is regarded as the backbone of all Chemometric models. This half day course would give a background on linear algebra that is required to understand common Chemometric techniques such as Principal Component Analysis (PCA) and Partial Least Squares (PLS). Since chemometric models are computationally intensive, the first day course should include a review of Matlab or equivalent software, and use relevant examples. (b) A full day course on PCA. This course would provide an in depth look at the basics of PCA and interpretation of PCA based models. This full day course would include hands-on computer time for the students to work on developing PCA based models. An example of software that may be used for hands-on training is Matlab based PLS Toolbox. (c) A full day course on PLS. This course would cover all basic regression techniques that include: Classical Least Squares (CLS), Multiple Linear Regression (MLR), Principal Components Regression (PCR) and PLS regression. This full day course would also include some computer hands-on time using software such as PLS Toolbox. (d) A half day course on ‘Common Mistakes in Implementing Chemometrics for PAT '. Implementation of Chemometrics for PAT poses some unique challenges e.g. logistics associated with model deployment and maintenance. This half day course would familiarize the students with various Chemometric tools that can be effectively used for various PAT applications as well as discuss some common pitfalls/watch outs. This half day course would not necessarily involve any hands-on computer time. Deliverables The contractor will provide a single offering of 24 hours of training on ‘Overview of Chemometrics' over 4 days; to our staff (maximum 20 attendees for the half day primer on Linear Algebra as well as the two full day courses on PCA and PLS and a maximum of 40 attendees for the last half day course on ‘Common Mistakes in Implementing Chemometrics for PAT') on site at FDA or very close to FDA campus in Maryland. Deliver presentation materials, handouts, binders for 20 and at least 10 demo versions of the software (assuming 2 students per computer) that will be used for the hands-on training. The demo version of the software will be available prior to the training and be loaded onto available computers in the training room. Scheduling may prohibit execution of the entire course over a consecutive 4 day span, which will require multiple trips by the provider. Period of Performance/Basis September 20-23, 2011 (Funded with FY11 funds) June 5-8, 2012 (FY 12 option) June 4-7, 2013 (FY 13 option) Place of Performance The training shall be delivered in the DC Metro Area. 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. Technical Capability is significantly more important than price. 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; 52.225-2 Buy American Certificate; 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 including subparagraphs: 52.222-3, Convict Labor 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 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. 52.212-2 EVALUATION -- COMMERCIAL ITEMS (JAN 1999) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Technical and past performance, when combined, are more important than cost or price. As offerors' rating for non-price factors approach equivalency, price becomes more important in the award decision. As pricing approaches equivalency, the non-price factors becomes more important in the award decision. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic 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 the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. ADDENDUM TO 52.212-2, EVALUATION -- COMMERCIAL ITEMS (JAN 1999) Evaluation of Proposals Proposals received in response to the solicitation will be evaluated based on best value to Government. Specifically, the best value approach permits the Government to select the most advantageous offer based on price factors and non-price factors. The proposals will be evaluated on the following factors: Technical Approach - The Government will evaluate the Offeror's understanding of the requirement and overall scope of work required, and the Offeror's approach to delivery of the training. Instructor Qualifications and Experience - The Government will evaluate the relevancy of the work experience of the instructor(s) to the scope of work to be performed and the environment in which instruction has been provided (i.e Federal and/or scientific). The Government will evaluate the instructor's experience in providing same or similar training as defined in the Statement of Work (SOW). Management Plan Factors to be considered: methodologies, preparation, performance measures, management tools, quality control, risk mitigation and communications Past Performance Relevancy: Past performance will be evaluated for its relevance to the requirements of this SOW. The Government will evaluate the Offeror's experience in the development and delivery of same or similar services The Government will evaluate the Offeror's past instructional experience in a Federal and/or scientific agency. Price The Government will use price analysis techniques to evaluate price to determine that prices are fair and reasonable. For purposes of evaluation only, price proposals will be evaluated based on the price for the maximum number of students and based on each course offering being offered one time each year. FDA intends to make an award soon after the response date of this notice and all quotations must be submitted via email and be received by 1:00 PM Eastern Time on 11 February 2011 to the attention of Emily Hunt, Emily.Hunt@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. ALL QUESTIONS REGARDING THIS SYNOPSIS/SOLICIATION MUST BE SUBMITTED IN WRITING NO LATER THAN 5:00 PM EASTERN TIME ON 08 FEBRUARY 2011. FAX QUOTES SHALL NOT BE ACCEPTED.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1083907/listing.html)
- Place of Performance
- Address: Washington DC Metro Area, United States
- Record
- SN02373490-W 20110206/110204234242-53c98bdbda17850c524ad1927dbef61b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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