Added: May 30, 2008 5:04 pm
Modified: Jun 03, 2008 6:14 pm
Track Changes
Description
This is a combined synopsis/solicitation for a firm fixed price purchase order using Simplified Acquisition Procedures found in FAR 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested. No other solicitation will be issued. The North American Industry Classification Code is 561492. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions.
STATEMENT OF WORK:
Verbatim Transcription and Official Summary Working Minutes Services.
Nineteen meetings are projected in the base year, however, the Government reserves the right to increase or decrease the number of meetings per year. Meetings will average fifty participants whose comments will need to be captured verbatim with each speaker identified.
Meetings are highly scientific and technical in nature, they usually last one day, but at times last 2 days, from 8am to 6pm. Court reporters are required to stay until the meeting ends.
Also, because of the wide variety of both the subject matter focus of each advisory committees and also the fact that each Committee Executive Secretary is a different person, an extensive amount of time must be allocated by the bidder to become familiar with both the content of each scientific area as well as the special needs and preferences for each committee with regard to how the summary minutes are presented. This requirement for interactive involvement between the court reporter/writer and the Committee Executive Secretary is continuous and ongoing not only because from time to time the person holding the position of Committee Executive Secretary may change which implies a change in the "working" summary preference requirements, but also because the content of the material discussed changes due to new discoveries in scientific research.
Transcribers must arrive one hour prior to the start of the meeting.
Deliverables:
1.Transcripts:
a. Hard Copies;
b. 1 original + 1 copy;
c.CD Roms;
d. 1 word formatted full transcript on 1 cd rom;
1 pdf format with only 100 pages on each cd rom please label cds accordingly (i.e., 1 of 3 Circulatory Meeting 9/19/07)
e. Closed Session:
2 Hard Copies (no CDs)
2. 1 audio of open and closed session labeled accordingly with the word audio
3. Summary Minutes:
Summary Minutes of the entire meeting, one document for each day, not to exceed 25 pages per day. Include CD Rom in WORD format.
Delivery:
Eight (8) business days after the meeting, verbatim text of proceedings are to be sent electronically to the attention of the Project Officer . After a cursory review for spelling and punctuation edits, transcripts will be sent back to Transcription Company for final printing and production of all other deliverables. Final product must be received within five (5) business days. The transcripts must be delivered to: Project Officer
Telephone Numbers:
TBD
Prior Notice requirements:
In general, advisory committee staff endeavors to give all possible practical prior notice of one-day and two-day meetings which may be as much be 1 or 2 or 3 weeks previous to schedule dates, however because of circumstances beyond the control of staff such as weather or other mitigating conditions, bidder must be willing to accept as little as 1 or 2 days prior notice and be ready with all trained and skilled personnel to perform all services required and to be present for entire duration of proceedings.
Contractor must be approved by FDA for access to privileged information and must be certified as being capable to receive and protect such information according to the requirements set forth in 21 CFR 20.90 (Disclosure to Contractor).
Price includes any additional staff hours and pages if meeting goes beyond tentative times listed.
BACKGROUND
The Food and Drug Administration (FDA) has a need for records of meetings held by the following:
CDRH Advisory Committees:
Anesthesiology & Respiratory Therapy Devices Panel
Circulatory System Devices Panel
Clinical Chemistry & Clinical Toxicology Devices Panel
Dental Products Panel
Dispute Resolution Panel
Ear, Nose & Throat Devices Panel
Gastroenterology & Urology Devices Panel
General Hospital & Personal Use Devices Panel
Hematology & Pathology Devices Panel
Immunology Devices Panel
Microbiology Devices Panel
Molecular and Clinical Genetics Panel
Neurological Devices Panel
Obstetrics & Gynecology Devices Panel
Orthopedic & Rehabilitation Devices Panel
Radiological Devices Panel
OTHER CDRH ADVISORY COMMITTEES:
National Mammography Quality Assurance Advisory Committee
(NMQAAC)
Technical Electronic Product Radiation Safety Standards Committee
(TEPRSSC)
Device Good Manufacturing Practice Advisory Committee
(DGMPAC)
BEST VALUE CRITERIA
BASIS FOR TASK ORDER AWARD
The Offeror should demonstrate in its proposal that the objectives in the statement of work are understood and offer a logical approach to their achievement. Award will be made to the offeror who is deemed most responsive, whose proposal conforms to all requirements, and is judged to represent the best value. To conduct a best value assessment, FDA will evaluate the offerors proposal submission based on Technical Elements, Price, and Past Performance as described below. Technical, Past Performance, and Price are of equal importance. As this is a best-value selection, the government may make tradeoffs in the factors below to arrive at a best value decision. The Government may award a task order on the basis of initial offers received, without discussions. Therefore, each initial offer should contain the Offeror's best terms from a cost and technical standpoint.
EVALUATION CRITERIA
The evaluation will be based on the completeness, thoroughness and demonstrated capabilities of the prospective Offeror in relation to the needs of the project as set forth in the RFQ. Each proposal must document the feasibility of successll implementation of the requirements of the RFQ. The Offeror should show that the objectives stated in the proposal are understood and offer a logical program for their achievement. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below.
Offerors should provide information on all of the following criteria.
A). Technical Solution
Offerors shall demonstrate a thorough understanding of the scope and complexity of the Performance Work Statement. The Offeror shall, through a detailed technical proposal, be able to thoroughly explain the product the Government is seeking to obtain through this requirement. The Offeror, through its proposal, shall explain how it intends to obtain this product within the given time fnune and in the most efficient and cost- productive manner. The Offeror must also show in its proposal the efforts required by the Government in order for the contractor to complete this task. Offerors must demonstrate that their share of savings reflects the risks involved andmarket conditions.
Corporate Capability and Expertise
Offerors must demonstrate the organizational resources, capability and experience to efficiently manage a requirement of this magnitude. Proposals must demonstrate Page 2 of 2
substantial and successfbl corporate experience in performing other Strategic Sourcing efforts of a similar nature and magnitude. Proposals must also include resumes for all staff proposed that clearly demonstrate the requisite level of experience and expertise to accomplish the requirements of this task order.
Strategic Sourcing Implementation Plan
Offerors must demonstrate a logical and effective planned approach for the use and management of personnel and resources required in the performance of this task order. Offerors must describe how these personnel and resources will be used to accomplish the specific elements of this task order. The offeror's proposal for "share-in-savings" or other form of incentive plan and the return on investment will be evaluated.
Past Performance Evaluation
FDA will evaluate the offeror's past performance in the conduct of similar tasks and their relevance to this acquisition.
Price
FDA will evaluate the offeror's submission/proposal on their ability to provide support at a reasonable and realistic price (to include any discounts offered). Bidders shall bid pricing per meeting based upon the estimates above with breakdowns for extra days or extra hours required.
LOCATION
All meetings will take place in the Gaithersburg and Rockville, Maryland areas.
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.
SECURITY AND PRIVACY
It is not anticipated that the contractor will be exposed to sensitive Agency information or data. But, the contractor agrees that contract personnel will sign an Non Public Information (NPI) form, and contract personnel will not divulge or release information or data developed or obtained in connection with performance of this contract, unless made public by FDA or upon written approval by the Project Officer.
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 General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov. HHS documents are found at: http://www.cdc.gov/irmo.
PAST EXPERIENCE AND PERSONNEL REQUIREMENTS
The bidder must be able to demonstrate past experience directly relevant to the types of work needed. Such experience includes projects performed in the past two years similar in scope to the requirements of this Statement of Work. Bidders shall provide resumes of on-site personnel.
Discussion in the proceedings often involves highly scientific and medical terminology, and in some cases, cutting-edge research that is not widely known in the greater community. All personnel [reporters, transcriptionists, proofreaders, summary writers, etc.] working on these transcripts and minutes must be completely familiar not only with the relevant subject matter but also the research that is being referred to by the participant specialists in order to faithfully document exactly what is being said in the presentations and discussions. A background of medical terminology for 5 years is suggested. The bidder must capture a completely accurate verbatim record of each and every word spoken by each and every participant, and each participant must be identified as the speaker of such remarks as it is vital that the correct name and title and affiliation be associated with the remarks being transcribed.
PERIOD OF PERFORMANCE: One base and two option years.
QUESTION DEADLINE: All questions must be submitted via email to Christopher.morningstar@fda.hhs.gov by 2:00pm, Eastern Time, Friday, June 6, 2008. No phone calls will be accepted.
PROPOSALS ARE DUE: 2:00pm, Eastern Time, Monday, June 9, 2008.
AWARD DATE: The anticipated award date is June 11, 2008; however, all dates in this announcement are subject to change.
PLEASE NOTE: In order to receive an award, contractor must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun and Bradstreet number and banking information.
PROVISIONS and CLAUSES: 52.252-2 clauses incorporated by reference
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 clause may be accessed electronically at this/these address(es): http://www.AGENCY.gov, http://www.AGENCY.gov/offices/cpo/AGENCYar.cfm, http://www.arnet.gov/far/loadmainre.html. The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.219-28, FAR 52.222-3, FAR 52.222-19, FAR 52.222-21, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, FAR 52.222-39, FAR 52.225-13, FAR 52.232-29, FAR 52.232-33, FAR 52.239-1, FAR 52.222-41, FAR 52.222-42.
Responses to this notice must be sent via email to christopher.morningstar@fda.hhs.gov. No phone calls will be accepted.
