MODIFICATION
R -- Human studies
- Notice Date
- 10/10/2007
- Notice Type
- Modification
- Contracting Office
- Environmental Protection Agency, Program Contract Service Center, 1200 Pennsylvania Avenue, Nw, Washington, DC 20460
- ZIP Code
- 20460
- Solicitation Number
- RFQ-DC-07-00335
- Response Due
- 10/13/2007
- Archive Date
- 11/13/2007
- Point of Contact
- Point of Contact, Thomas Martinez, Purchasing Agent, Phone (202) 564-1418
- E-Mail Address
-
Email your questions to U.S. Environmental Protection Agency
(martinez.thomas@epa.gov)
- Description
- NAICS Code: 541620 NAICS Code: 541990: The U.S. Environmental Protection Agency (EPA), via market research, will be going to approximately three (3) vendors for quotes. STATEMETN OF WORK NCEA TECHNICAL SUPPORT FOR PROFESSIONAL SERVICES Project Identification: Consultation for Air Quality Science Assessment for Particulate Matter: Human Clinical Studies of Acute Morbidity Period of Performance: Date of Award ? September, 30, 2009 Type of Purchase Order: Firm Fixed Price (inclusive of all travel costs and fees) Estimated Level of Effort: 213 Hours for Tasks 1-7 (50 Hours for Optional Tasks 8-9) INTRODUCTION The Clean Air Act requires periodic review of the National Ambient Air Quality Standards (NAAQS). As a part of this process, the National Center for Environmental Assessment (NCEA) of the U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD) reviews and integrates new scientific information on the Criteria Air Pollutants in an Integrated Science Assessment (ISA), historically known as an Air Quality Criteria Document (AQCD). The EPA is now in the process of reviewing the NAAQS for particulate matter (PM). The last review of the PM NAAQS was completed in 2006. At that time, the EPA lowered the level of the 24-hour PM2.5 standard from 65 ?g/m3 to 35 ?g/m3, and retained the current annual fine particle standard of 15 ?g/m3. The Agency also retained the existing national 24-hour PM10 standard of 150 ?g/m3, while revoking the annual PM10 standard. The Agency is now initiating the next review of these standards. The current review of the NAAQS for PM is targeted for completion in October 2011, to meet the five year-interval requirement for review of the criteria and NAAQS for PM (as described in the Clean Air Act, section 109(d)(1)). As one of the first steps in the review process, the first external draft of the PM ISA is targeted for release in August 2008 for review by the Clean Air Scientific Advisory Committee (CASAC) and the public at a public meeting to be held in autumn 2008. The EPA?s proposed schedule also includes a number of target dates for the second draft and final PM ISA. The scientific information on PM shall be evaluated, integrated and synthesized in an Integrated Science Assessment and its annexes. Initial draft materials for the ISA and annexes will be reviewed at a peer review workshop sponsored by the EPA. These initial draft materials for the ISA will be written prior to the peer review meeting using discipline-specific (i.e., epidemiology, toxicology, controlled human exposures, etc.) findings from each respective section and integrating them into a concise document. Following this meeting, the ISA will be revised based on author and peer reviewer comments, resulting in an external review draft which will be released for public comment and CASAC review. The EPA anticipates preparing two drafts of the PM ISA for public and CASAC review prior to the completion of the final PM ISA. Under this order, as outlined in the tasks described in the statement of work, the EPA seeks the professional services of an expert scientist(s) to assist with the review, critical evaluation summary, and integration of the available scientific database on human health risks from PM exposure. In particular, assisting in the preparation of the PM ISA sections related to human clinical studies (controlled human exposures). TASKS The Contractor shall accomplish the following tasks and shall complete these tasks according to the estimated deliverable schedule below. Because of the importance of these tasks to EPA?s mandated environmental objectives, any late deliverables may negatively affect the outcome of the entire project. TASK 1. Submit an Expanded Section Outline and Joint Quality Management/Quality Assurance Project Plan (JQM/QAPP) The Contractor shall submit a Joint Quality Management/Quality Assurance Project Plan (JQM/QAPP) for the product specified in Task 3 within 10 days of award of the order (see Attachment 1 for an outline of the plan). The JQM/QAPP shall address issues of quality assurance and control procedures and issues of the use of secondary data to produce the deliverables specified in Task 3. The JQM/QAPP must be approved by the EPA Technical Project Officer (PO) within 7 days of receipt. In addition to the JQM/QAPP, the Contractor shall submit to the EPA PO an expanded section outline within 10 days of award of the purchase order. The expanded outline shall provide a clear presentation of the scientific issues (see Attachment 2) and identify some preliminary key studies to be discussed in the controlled human exposures/clinical studies section of the PM ISA. The intent of the outline is to ensure that the Contractor has a clear understanding of the specified technical direction and guidelines for the completion of this section. TASK 2. Participate in Preliminary Meeting for Authors NCEA shall hold a teleconference to assess the current understanding of PM and the expanded outline provided by the Contractor (Task 1). This meeting will provide an opportunity to discuss the content and organization of the document as appropriate, and to clarify the requirements in the Statement of Work. Potential participants will include NCEA staff and authors or contributors who may participate in the development of the PM ISA. This teleconference is intended to provide the Contractor with important scientific guidance in fulfilling the tasks and responsibilities outlined in the Statement of Work, and to raise and address issues of importance in assessing human health effects of PM exposure, specifically within the context of human clinical studies (see Attachment 2). It will also provide the Contractor with a clear understanding of the nature and schedule of the PM ISA preparation. The meeting is tentatively scheduled to take place in November, 2007. The Contractors shall be notified by the PO of the exact date of the meeting within two weeks of the award. TASK 3. Prepare Written Section(s) for the ISA Relevant to Health Effects in Response to Controlled Human Exposures The Contractor shall prepare a text section for the PM ISA that concisely reviews the most relevant scientific literature related to health effects following controlled human exposures to PM. This will include a brief review of the controlled human exposure studies described in the 2004 Air Quality Criteria Document for Particulate Matter and the 2006 Provisional Assessment of Recent Studies on Particulate Matter, as well as a comprehensive review of all new studies not included in either of these two documents (a sample outline is presented in Attachment 2). In addition to the text section, the Contractor shall prepare tables that summarize all newly published studies on the assigned topic. In order to successfully complete Task 3, the Contractor shall perform the following subtasks. Subtasks (1) The Contractor shall present a brief summary of the state of knowledge concerning the evidence from controlled human exposures on the toxicological effects of PM at the time of the writing of the 2004 PM AQCD and the 2006 Provisional Assessment of Recent Studies on PM. Key conclusions shall be presented, which will frame the discussion of new studies and issues. (2) The Contractor shall perform a comprehensive and detailed literature search of all new peer-reviewed articles, books, and reports, either published or accepted for publication, that present relevant health effects data and information from controlled human exposures to PM that were not included in the previous PM AQCD. The Contractor shall provide information on QA procedures used to conduct the comprehensive literature search, including keywords, specific databases and search engines used, and limits placed on the searches. The basis used for selecting controlled human exposure literature for the present assessment include whether a given study reports sufficient information on: Particle type and collection or generation method Analyses of effects of specific types of PM or indicators related to PM sources (e.g., diesel exhaust, concentrated ambient particles, wood smoke, etc.) and/or size fractions PM exposure concentration Exposure duration Exposure system (i.e., exposure chamber, bronchial instillation, etc.) Analytical and statistical methods Using these criteria, the Contractor shall document reasons for which potentially relevant studies have been omitted from inclusion in the human clinical section. (3) For each study identified from Task 3, Subtask 2, the Contractor shall evaluate and consider: PM sources, components, or other characteristics that may be responsible for the observed health outcomes Method(s)/instrument(s) used to characterize PM properties If the measured health endpoints were meaningful If the analyses used were appropriate and properly performed and interpreted If study design limitations were acknowledged If the reported findings were internally consistent, biologically plausible, and coherent with other known facts and/or studies In addition, for each study the Contractor shall document available human subject ethics information, which may include information on informed consent, institution review approval, and ethics standards under which the study was conducted. (4) The Contractor shall prepare tables describing the newly published studies, which shall include for each study: Number, age and health status of subjects tested within each gender Particle type, size, component, source, and origin Method(s)/instrument(s) used to characterize PM properties Exposure concentration and duration Exposure protocol (e.g., intermittent exercise, co-exposures, etc.) Principal study findings along with study strengths and weaknesses (5) The Contractor shall perform a balanced and objective evaluation that summarizes, interprets, and synthesizes the most important studies in the controlled human exposure literature on the health effects of PM. This shall include an integrated discussion of data from new studies, as well as studies that have been described in the previous PM AQCD. To the extent possible, the review shall include a comparison of study results with different PM components or sources, as well as a discussion of possible mechanisms and pathways responsible for the observed health effect. In addition to the written text, the results and conclusions of the studies shall be presented in quantitative summary tables and figures as appropriate. As part of this subtask, the Contractor shall summarize and integrate the literature in a manner that addresses the issues that have been identified and revised throughout the process of development of the document. For the health effects reviewed, the Contractor shall provide a clinical and public health perspective and identify new issues and literature as appropriate. The Contractor shall develop this work product to aid in the development of the ISA, a concise and focused assessment that addresses the issues identified and provides the framework for the PM NAAQS. The Contractor shall also provide EPA with a copy of all journal articles referenced and include a thorough bibliography of references. TASK 4. Review and Evaluate the Preliminary Draft of the Health Effects Chapter of the PM ISA and Attend the Peer Review Workshop to Discuss the Draft A preliminary draft of the health effects chapter of the PM ISA will be developed by the EPA using the drafts of the authors? sections from the various health disciplines (e.g., human clinical, epidemiology, toxicology, etc.). The Contractor shall review and provide written comments on this entire chapter prior to the peer review workshop. The draft chapter will be provided to the Contractor by the PO two weeks in advance of the event. The Contractor shall attend the peer review workshop which will be convened to review the draft section(s) and preliminary health effects chapter of the ISA to ensure that issues pertinent to review of the PM NAAQS have been adequately addressed, and that all relevant, new literature has been identified. The Contractor shall be present to discuss his/her specific draft section of the PM ISA, as well as to provide input on other related draft sections. This workshop is expected to take place over a two day period in April 2008. TASK 5. Revise Draft Section of PM ISA in Response to Comments Received at the Peer Review Workshop The Contractor shall prepare any revisions on his/her draft sections based on recommendations from the peer review workshop. A post-meeting written response to comments shall be delivered to the EPA PO two weeks after the workshop. Upon receipt of the revised drafts, the EPA will process the various sections to produce a unified word processed draft version of the PM ISA that includes text, figures, tables, and references. In so doing, the EPA will first examine the text for quality control, both technical and editorial, and implement appropriate revisions. The EPA will then integrate the material across the various sections and chapters of the document, and will interpret the overall available information. The Contractor shall be available to assist in the development and synthesis of the ISA. The EPA will assume primary authorship of the ISA in this process. Contributing authors are listed in the final document as appropriate. TASK 6. Prepare First External Review Draft of PM ISA EPA will process the various PM sections and complete the development of the external review draft ISA. The Contractor shall be available to assist in the development and synthesis of the ISA. This draft will be submitted to CASAC and the public for review. TASK 7. Attend and Participate in the CASAC Review Meeting and Respond to Public Comments The Contractor shall attend and participate in the public meeting conducted by CASAC that will review the first external draft of the ISA for PM. In particular, the Contractor shall be prepared to both participate in the discussion of his/her section as well as provide preliminary oral responses to public comments. These comments will be provided to the Contractor as available before the CASAC public meeting. The CASAC public meeting will be held in Research Triangle Park, NC over a 2-3 day period. The Contractor shall be notified of the exact schedule at least 30 days in advance of the meeting by a letter from the EPA PO. OPTIONAL TASKS The Government may elect to exercise one or both of the optional tasks listed below (Tasks 8 and 9). The Contractor shall not perform any work associated with these optional tasks until a written confirmation is received from the EPA Contracting Officer (CO) stating that one or both of the optional tasks has been authorized and funded accordingly. NOTE: The specific requirements for the optional task(s), if exercised, shall be provided to the Contractor by the EPA CO in the Contract modification, along with the dates for completion. TASK 8. Revise Chapter/Section for the EPA?s Second External Review Draft Document The Contractor shall be responsible for preparing written comments in response to any public or CASAC review comments received in his/her draft sections of the document. Revisions shall be made to the Contractor?s draft sections in response to CASAC and public comments, and shall reflect relevant new information published in the peer-reviewed literature since the completion of the first external review draft. Considerable effort will be made to incorporate and synthesize the most current published and peer-reviewed scientific information into the document. The Contractor shall revise the draft section(s) to be consistent with the ISA. The Contractor shall provide to the EPA PO the revised, completed section for incorporation into the second external review draft of the PM ISA. TASK 9. Revise Chapter/Section for EPA?s Final Document The Contractor shall revise his/her section of the second external review draft document in response to any public review comments or any comments received from the CASAC review of the second external review draft document. Written responses to any public or CASAC review comments shall also be prepared. The revised section will be used to produce the EPA?s revised Integrated Science Assessment for PM. The Contractor shall provide to the EPA PO the revised, completed sections/chapter, as well as written responses to the public and CASAC comments that were incorporated into the final draft. DELIVERABLES AND PROFESSIONAL SERVICES The Contractor shall provide written products to the EPA PO as specified in the above tasks. All products must be of high quality, written in a clear concise style, with a logical organization and presentation. Products not adhering to these standards, or substantially lacking scientific quality, will not be accepted. The Contractor shall use current EPA guidelines for performance of work, unless otherwise specified. The Contractor shall provide all written materials and responses in both hard copy and electronic format. Hard copies and electronic versions of all completed text, tables, and figures shall be submitted to EPA by the deadlines established in the statement of work. All of NCEA?s word processing activities are performed in Microsoft Word (Windows). Macintosh and DOS files are unacceptable. Similarly, WordPerfect files are unacceptable. Figures and other graphics are acceptable in the following formats: Adobe Illustrator (.AI), CorelDraw (.CDR), WP Presentation (.WPG), Lotus Pic (.PIC), MACPICT (.PCT), PostScript (.EPS) (include 100-dpi TIF preview), TIFF Bitmap (.TIF), Photoshop (.PSD, .JPG, or .GIF) (all bitmap formats should be at least 200 dpi for acceptable reproduction on 300-dpi laser printers), Windows Metafiles (.W
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