SOLICITATION NOTICE
R -- Professional Services of Medical Technical Writer - Word Format Synopsis
- Notice Date
- 1/15/2010
- 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
- 10-223-SOL-00044-rfq1068284
- Archive Date
- 2/4/2010
- Point of Contact
- Gwen D Hubbard, Phone: (301) 827-7172, Emily Hunt, Phone: 3018277109
- E-Mail Address
-
gwendolyn.hubbard@fda.hhs.gov, emily.hunt@fda.hhs.gov
(gwendolyn.hubbard@fda.hhs.gov, emily.hunt@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Medical Technical Writer This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This solicitation is issued as a Request for Quotations (RFQ). This solicitation is unrestricted, the NAICS code for this action is 541690 and the business size standard is $7 million. The Food and Drug Administration intends to negotiate a firm fixed price contract for technical writing services for medical meetings using FAR Part 13 Simplified Acquisition Procedures. This solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular 2005-38, effective December 10, 2009. STATEMENT OF WORK Technical Writing Services for FDA co-sponsored Phenotype Standardization Project Consensus Conference 1.0Introduction 1.1Background The Critical Path Initiative is FDA’s effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or “proof of concept” into a medical product. One scientific hurdle on the Critical Path is a lack of understanding of the mechanistic and genetic basis of extremely rare, but serious adverse drug reactions. These reactions, such as drug-induced liver injury, may affect only one patient in several thousand. The scientific challenge is to discover and validate biomarkers that can identify individuals who are at high risk of developing serious adverse events (SAEs). This knowledge would lay the scientific groundwork for the development of personalized approaches to treatment that would enhance the safety of drugs by identifying individuals susceptible to specific adverse drug reactions. The International Serious Adverse Events Consortium (SAEC) is a non-profit consortium actively engaged in research to identify and validate DNA-variants useful in predicting the risk of drug-induced serious adverse events. The rarity of drug induced serious adverse events and the absence of efficient surveillance/research networks, makes it extremely difficult for any one company/research entity to accrue enough SAE cases and controls to conduct effective whole genome studies and follow on hypothesis driven molecular research. To date, the SAEC has partnered with “academic investigators” to build a variety of SAE “research cohorts”. To obtain the research subjects for SAE research in the scale and diversity required, new collaborations with large integrated researcher groups and health networks (with electronic health records) will need to be developed. In order to expand SAE research in this direction, standardized phenotypes and assessment methods must be developed and published. To date, the published literature is variable on such definitions and assessment models. The FDA is co-sponsoring an international conference, to be held in the spring of 2010, to standardize the case definitions of three serious drug-related adverse events (SAEs), serious skin rash (SSR)/acute hypersensitivity syndrome (AHSS), drug-induced liver injury (DILI) and Torsades de Pointes (TdP). The result of this conference will be standard phenotypic definitions for each of these adverse events which can then be adopted and widely used by the clinical/scientific/biomedical research communities to better standardize research into the genetic basis of SAEs. The technical writing group will work with three Expert Working Groups to develop technical documents, scholarly articles and decision trees which describe the standard phenotypic definitions for each of the SAEs. 1.2Objective The principle objective is to provide medical writing services to the Office of Translational Sciences within the FDA Center for Drug Evaluation and Research, to develop a published set of standard phenotypic definitions and associated diagnostic criteria to characterize the clinical features required for the identification of subjects with the following SAEs: Serious skin Rash (SSR)/Acute Hypersensitivity Syndrome (AHSS), Drug Induced Liver Injury (DILI), and LQT/Torsades de Pointes (TdP) that will be addressed during the Phenotype standardization project consensus conference. 1.2.1The purpose of this procurement is to develop (a) a common format for serious drug-related adverse event case definitions, (b) technical documents with detailed diagnostic criteria and (c) targeted acceptable, which adheres to publishing house standards for each journal and additional information as required for publication in relevant journals such as the New England Journal of Medicine; the American Journal of Cardiology, and the American Journal of Clinical Dermatology, journals that describe the phenotype standards for each of three (3) serious adverse drug reactions: • Serious Skin Rash (SSR)/Acute Hypersensitivity Syndrome (AHSS) • Drug–induced Liver Injury (DILI) • LQT/Torsades de Pointes (TdP) 1.2.1.1Develop algorithm outlining the clinical diagnostic criteria to aid in phenotyping each SAEs identified in Section 1.2 1.2.1.2Assist the three (3) expert working groups (EWGs), comprised of 4-5 disease experts with representation from the international regulatory agencies European Medicines Association (EMEA) and the Ministry of Health, Labour, and Welfare (MHLW), in developing a common framework for the SAE phenotype definitions and writing draft phenotype definitions for each of the 3 SAE areas described in 1.2.1 prior to the conference in spring 2010. 1.3Project Scope Independently and not as an agent of the Government, the contractor shall furnish the necessary personnel, and services, except as provided in the schedule, and otherwise do all things necessary to the performance of the work as described below: Attend one (1) orientation meeting with FDA and with conference co-sponsors at the FDA in Silver Spring Maryland to develop a detailed work plan including: Description of the project’s objective List of personnel participating in the project Breakdown of the project into specific tasks and a schedule indicating when each task will be started and when it will be completed. Participate by teleconference in the EWG meetings as needed and work with each group to determine a standard format to be used when publishing the SAE phenotype descriptions. Participate by teleconference in seven 2 hour meetings in the EWG meetings to provide working draft phenotype documents for each of the 3 SAE areas prior to the conference, which is based on input from the working group and additional background and reference materials provided by the EWGs Travel to and attend the 1-2 day conference, to be held at the Wellcome Trust Sanger Institute in Hinxton, Cambridge, UK in late Spring 2010 (date to be determined) in order to interact with conference participants to accurately capture the main conference conclusions. Develop (3) 15-20 page technical documents, based on the results of the conference which contain a detailed background, case definition and other information for each of the 3 SAEs specified in section 1.2.1. Develop a decision algorithm for each of the SAEs specified in section 1.2.1. Develop three (3) targeted, 3-5 page manuscripts, for each adverse drug reaction specified in section 1.2.1, based on the technical documents, but in accordance with publishing guidelines for each relevant journal for publication in journals as specified in section 1.2.1, that describe the phenotype standards for each of three (3) serious adverse drug reactions. 1.4Description of Work Program Planning The Contractor shall provide the expertise as required throughout the term of the contract and will advise, facilitate and assist in providing the required draft and final documents as described in section 2. Project Management and Control The Contractor shall provide quarterly status reports and be available to discuss with Project Officer. 1.5 Task Deliverables and Milestones Item #, Deliverables, and Due Dates 1 Attendance at an orientation meeting with FDA and conference co sponsors at the FDA in Silver Spring, Maryland to develop detailed work plan.within 1 week of contract award 2 Participate by teleconference in the EWG meetings as needed to develop deliverables 3 and 4.throughout Q1 of 2010 3 Develop a standard format that will be used for developing the detailed standard phenotype definitions for each of the (3) SAE phenotype documents.March 1, 2010 4 Three (3) working draft phenotype documents, one each for the 3 SAE areas to be completed prior to the conference. Drafts will be based on input from the working group and additional background and reference materials provided by the EWGs. The working draft phenotypes will all follow the format developed in deliverable 3.May 1, 2010 5 Travel to and attendance at, the 1-day conference, to be held at the Wellcome Trust Sanger Institute in Hinxton, Cambridge, UK in late Spring 2010 in order to capture a summary of the main conference outputs. All travel arrangements and related expenses will be the responsibility of the contractor. [conference date] 6 Develop three technical documents, one each for the 3 SAE areas, based on the results of the conference. Each should contain a detailed background, case definitions and other information provided by each of the 3 SAE working groups. July 1, 2010 7 Develop a decision algorithm or decision tree for each of the SAEs.July 1, 2010 8 Three (3) targeted manuscripts, based on the technical documents described under deliverable 6, but suitable for publication in relevant journals, describing the standard phenotype definitions resulting from the conference for each of three (3) serious adverse drug reactions Sept 1, 2010 Criteria for Acceptance OTS will review contractor deliverables in accordance with specifications and standards stated in the criteria established and any directives issued during the term of this contract. OTS Management has the authority to accept or reject deliverables. The acceptance of deliverable and satisfactory work performance required herein shall be based upon the timeliness, accuracy and suitability of the deliverables. The specific deliverables and schedule for delivery shall be as agreed upon and documented. All documents, plans, diagrams, presentations, etc., are to be submitted by email, flash drive, in hardcopies, or burned onto a CD. Deliverable shall be submitted to the Project Officer who initiated the request. a. Contractor shall provide monthly status report that provides information about the current status and anticipated completion date for any deliverable. The Contractor shall also include information about any unanticipated problems with completion of any deliverable. b. Contractor shall meet with OTS to review and discuss project outcomes with all relevant FDA organization components. (how many meetings?) 2.4 Period of Performance - January 2010 – September 2010 3.4 Location, Work Schedule, and Travel Unless otherwise specified, meetings between contractor and FDA may be in person at FDA/CDER or via conference call and/or web conferencing. Unless otherwise directed, the contractor shall adhere to standard work hours, working no more than 40 hours per week and observe all U.S. Government holidays. 4.4 Status Reporting The Contractor shall provide quarterly reports on the status/progress of deliverables and any current or anticipated problems with required activities. 5.4 Security and Privacy Performance of work may require the contractor personnel to have access to and use of data and information which may be considered proprietary to regulated industry, a government agency or Government contractor, or which may otherwise be of such nature that its dissemination or use, other than in performance of a subsequent work statement, would be adverse to the interest of FDA or others. (a) The Contractor agrees, in the performance of this contract, to keep the information furnished by the Government and designated by the Contracting Officer or Contracting Officer’s Technical Representative in the strictest confidence. The Contractor also agrees not to publish or otherwise divulge such information in whole or in part, in any manner or form, nor to authorize or permit others to do so, taking such reasonable measures as are necessary to restrict access to such information while in the Contractor’s possession, to those employees needing such information to perform the work provided herein, i.e., on a “need to know” basis. The Contractor agrees to immediately notify the Contracting Officer in writing in the event that the Contractor determines or has reason to suspect a breach of this requirement. (b) The Contractor agrees that it will not disclose any information described in Subsection (a) to any persons or individual unless prior written approval is obtained from the Contracting Officer. The Contractor agrees to insert the substance of this clause in any consultant agreement or subcontract hereunder. 6.4 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). 2.0Evaluation Criteria for Competitive Proposals The Government will award a purchase order to the responsive contractor who offers the “best value” to the Government in accordance with the requirements of the Statement of Work. The anticipated procurement procedures are those prescribed by FAR Part 13 for Simplified Acquisition Procedures. Written quotations will be evaluated against the following evaluation factors listed in descending order of importance: Technical Understanding and Approach, Past Performance/Experience and Personnel. 2.1Evaluation Criteria This evaluation shall be based upon the completeness and thoroughness of the proposal submitted. The Offeror should demonstrate that the objectives stated in the proposal are understood and offer a logical program for their achievement. The technical proposal shall be submitted electronically via e-mail to the Contracting Officer. The technical proposal described below shall be limited to 20 pages not including resumes or bibliographies, with no less than an 11 point font, with the majority of the text double-spaced. Brief biographical sketches of personnel may be provided and are not included in the 20 page limit. The Offeror’s proposal should present sufficient information to reflect a thorough understanding of the work requirements and a detailed plan for achieving the objectives of the scope of work. Technical proposals shall not merely paraphrase the requirements of the Agency’s scope of work or parts thereof, or use of phrases such as “will comply” or “standard techniques will be employed.” The technical proposal must include a detailed description of the techniques and procedures to be used in achieving the proposed end results in compliance with the requirements of the Agency’s scope of work. 3.1 Evaluation Factors Factor 1: Technical Understanding and Approach (Maximum possible score = 35) Provide a comprehensive statement of the scope and purpose of the project to demonstrate complete understanding of the intent and requirements. This understanding indicates a clear comprehension and awareness of the contract objectives. Objectives: State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and the relationship to comparable work in progress elsewhere. Approach: Use as many subparagraphs as needed to outline clearly the general plan of work that specifically addresses the services in the Statement of Work. Methods: Describe in detail the methodologies that would be used for the project, indicating level of experience with each. Factor 2: Past Performance/Experience (Maximum possible score = 35) The offeror shall describe their past performance, identifying other organizations with which they have participated in similar efforts including the degree of their involvement, the size and complexity of the organization and other information describing their experience. Offerors shall submit a list of three (3) references. Contracts listed may include those entered into by and between the Federal Government, agencies of State and local governments and commercial customers. Contractors that are newly formed entities without prior contracts should list contracts and subcontracts as required for all key personnel. The reference list of the three (3) references shall include the following information for each contract and subcontract: 1. Name of contracting activity 2. Contract number (if applicable) 3. Contract type 4. Total contract value 5. Contract work 6. Contracting officer and telephone 7. Program manager and telephone 8. Provide examples of work products completed similar to the work requested in SOW no longer than five (5) double-spaced pages in length. Each Offeror shall be evaluated on their performance under existing and prior contracts for similar products or services. Performance information will be used as an evaluation factor against which contractors’ relative rankings will be compared to assure best value to the government. The government will focus on information that demonstrates quality of performance relative to the size and complexity of the procurement under consideration. Factor 3: Personnel (Maximum possible score = 30) Each Offeror shall be evaluated on the capability and qualifications of staff for the performance of tasks listed in the SOW. Offerors must identify in-house or team staff and describe their capabilities and expertise in substantive areas related to activities described in the SOW. The Offerors shall demonstrate the qualifications, education, and experience of the proposed project manager and medical writer. Resumes or CVs should be submitted. The following FAR clauses shall apply to this solicitation: FAR Part 52.212-1 Instructions to Offerors-Commercial Items; 52.212-2 Evaluation Commercial Items; 52.212-3 Offerors Representations and Certifications; 52.212-4 Contract Terms and Conditions; and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items. In accordance with FAR 52.204-7 Central Contractor Registration, contractors are required to register in the Central Contractor Registration (CCR) database http://www.ccr.gov, PRIOR to award of any contract. All responsible sources that can provide and meet the above requirement shall submit written technical and price quotations by 2:30 p.m., EST, January 20, 2010 via mail or by fax (301) 827-7106. All questions shall be submitted in writing by fax or email: Gwendolyn.hubbard@fda.hhs.gov by noon, January 18, 2010. All sources must submit along with their written quotes a nine-digit numeric Duns number which is assigned by Dun & Bradstreet. To apply for a Duns number, please call 1-866-705-5711.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/10-223-SOL-00044-rfq1068284/listing.html)
- Place of Performance
- Address: Rockville, MD, Rockville, Maryland, United States
- Record
- SN02043647-W 20100117/100115235609-04f7eef17864b983b874880829db5e21 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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