MODIFICATION
R -- Professional Services of Medical Technical Writer - Revised SOW and Responses to Questions - Amendment 1
- Notice Date
- 2/5/2010
- Notice Type
- Modification/Amendment
- 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
- 3/6/2010
- 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
- Total Small Business
- Description
- SF 30 Revised Scope of Work and Responses to Questions ATTACHMENT A Revised Statement of Work Technical Writing Services 1.0Introduction 1.1Background The Critical Path Initiative is the Food and Drug Administration’s (FDA) 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 (iSAEC) 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 iSAEC 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, serious skin rash (SSR)/acute hypersensitivity syndrome (AHSS), drug-induced liver injury (DILI) and Long Q-T (LQT)/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 (EWG) 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 (OTS) within the FDA Center for Drug Evaluation and Research (CDER), 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) common formatting 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. Examples include the New England Journal of Medicine, the American Journal of Cardiology, and the American Journal of Clinical Dermatology; or 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: 1.3.1Attend 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: 1.3.1.1.1Description of the projects objective 1.3.1.1.2List of personnel participating gin the project 1.3.1.1.3Breakdown of the project into specific tasks and a schedule indicating when each task will be started and when it will be completed. 1.3.2Participate 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. 1.3.3Participate 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 1.3.4Travel to and attend the 1-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. 1.3.5Develop (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. 1.3.6Develop a decision algorithm for each of the SAEs specified in section 1.2.1. 1.3.7Develop 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. 1.4 Description of Work 1.4.1 Program Planning The contractor will 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. 1.4.2 Project Management and Control The contractor will provide quarterly status reports and be available to discuss with Project Officer. 2.0 Task Deliverables and Milestones Item #DeliverableDate Due 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 2Participate by teleconference in the EWG meetings as needed to develop deliverables 3 and 4.throughout Q1 of 2010 3Develop 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 4Three (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 5Travel 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] 6Develop 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 7Develop a decision algorithm or decision tree for each of the SAEs.July 1, 2010 8Three (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 reactionsSept 30, 2010 3.0 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 shall be as agreed upon and documented. All documents, plans, diagrams, presentations, etc., are to be submitted by email, or, in hardcopies. Deliverable will be submitted to the Project Officer who initiated the request. a.Contractor will provide monthly status report that provides information about the current status and anticipated completion date for any deliverable. The contractor will also include information about any unanticipated problems with completion of any deliverable. b.Contractor’s meetings with OTS to review and discuss project outcomes will involve all relevant FDA organization components. 4.0 Period of Performance Performance Period: February 2010 – October 2010 5.0 Location, Work Schedule and Travel Unless otherwise specified, meetings between contractor and FDA maybe in person at FDA/CDER or via conference call and/or web conferencing. 6.0 Status Reporting The contractor will provide monthly reports on the status/progress of deliverables and any current or anticipated problems with required activities. 7.0 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. 8.0 Evaluation Criteria for Competitive Proposals The Government will award a simplified 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 in addition to cost or price. 8.1 Evaluation Criteria 8.1.1 This evaluation shall be based upon the completeness and thoroughness of the proposal submitted. 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. 8.1.2 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. 8.1.3 Evaluation Factors Factor 1: Technical Understanding and Approach (Maximum possible score = 50) Factor 2: Past Performance/Experience (Maximum possible score = 30) Factor 3: Personnel (Maximum possible score = 20) 8.1.3.1 Technical Understanding and Approach 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. 8.1.3.2 Past Performance/Experience The contractor 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. Contractors shall submit a list of three (3) references. Contracts listed may include those entered into by 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 contractor will 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. 8.1.3.3 Personnel Each contractor will 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 medical writer. Resumes or CVs should be submitted. Price Evaluation If the technical proposals are essentially equal or are approximately equal in the technical ability, then the award may be made on the basis of lowest cost. Additionally, cost would be evaluated on the basis of its realism and acceptability. ATTACHMENT B Question: Could you possibly extend the deadline for submitting proposals? The solicitation was posted on FedBizOpps on January 15. The due date is only two business days later (when taking into consideration the Martin Luther King Day holiday). It is not possible for companies--especially small businesses--to produce credible proposals that quickly. Based on our past experience, a response time of at least two weeks is typical for solicitations like yours. Response:The deadline is extended to February 19, 2010; see Modification Three (3). Question:Is a contracting company currently supplying the services mentioned in the Statement of Work or has such a company done so in the last 12 months? If so, what is the name of the company? Response:There are no incumbent currently providing theses services. Question:Is it correct to assume that you would expect 3 separate subject matter expert writers, one each to focus on each of the 3 serious adverse drug reactions or is the program office anticipating that the writing group meetings and deadlines will not conflict and one medical writer can perform all the writing? Response:Only one writer is required. Question:If different writers, can we assume that they all three would travel to the UK to be able to focus on the different areas? Response: See response to question above. Question:Should we estimate travel costs to include 1 or 2 conference days? The RFQ states 1-2 days on page 3 and 1 day in the Task Deliverables on page 4. Response: Travel cost not –to- exceed $7,500.00 Question: On page 3, under Project Scope, it requests participation in seven 2 hour meetings in the EWG meetings. Do we interpret that to mean seven meetings for each of the 3 SAE areas for a total of 21 two hour sessions or one writer for only seven meetings? Response:See revised statement of work. Question:This FAR Part 13 acquisition is stated as being conducted in accordance with the format in FAR 12.6. However, it is not clear whether FAR 13.5 is, or is not, applicable. In other words, is the acquisition above the $100,000 simplified acquisition threshold? Response:No, Far Part 13.5 is not applicable to this requirement. Question:The synopsis makes reference to a “project manager and medical writer”, but it is not clear whether the project team is to consist of just these two staff members or what the role of the project manager is with respect to meetings and travel to the UK. There does not seem to be any provision for backup staff in case the sole medical writer becomes unavailable due to health or other reasons. Response:Only one writer is required. Question:The synopsis states that the agency intends to negotiate a firm fixed price contract. However, the description in the notice/solicitation contains statements/requirements that are either not appropriate to fixed price. Response:See revised statement of work. Question:Why is contra actor required to “adhere to standard work hours, working no more than 40 hours per week and observe all U.S. Government holidays.” Is this consistent with travel to the UK? Response:Only one writer is required. Question:Contractor is required to conform to applicable laws, regulations, policies, and standards but they are not identified. Response:Reference removed in its entirety. Question:The combined synopsis/solicitation appears to be a draft; it explicitly states in the text “(how many meetings?)”. Delivery schedule and deliverables are stated all over the solicitation rather than in a specific section. See requirements for reports. Response:See revised statement of work Question:Evaluation criteria do not identify cost as an evaluation factor and fail to state relative value of technical to cost in making award. Response: See revised evaluation criteria in the statement of work. Question:The use of Past Performance as an evaluation factor and the requirement to submit 3 references is not clear with respect to whether they are related to the same or different evaluation areas. Statements that refer to “offerors” are not correct for a request for quotations. Offerors that are to be evaluated under “existing and prior contracts for similar products or services” appears inconsistent with the uniqueness of the required services. Response:Addressed in the revised evaluation criteria.
- 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
- SN02059547-W 20100207/100205235612-b7ce38cb49176d946d68e9f177349e85 (fbodaily.com)
- Source
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