SOLICITATION NOTICE
R -- human services
- Notice Date
- 9/27/2007
- Notice Type
- Solicitation Notice
- Contracting Office
- Environmental Protection Agency, Program Contract Service Center, 1200 Pennsylvania Avenue, Nw, Washington, DC 20460
- ZIP Code
- 20460
- Solicitation Number
- RFQ-DC-07-00337
- Response Due
- 10/13/2007
- Archive Date
- 11/13/2007
- Point of Contact
- Point of Contact, Thomas Martinez, Purchasing Agent, Phone (202) 564-1418
- 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. STATEMENT OF WORK NCEA TECHNICAL SUPPORT FOR PROFESSIONAL SERVICES I. Project Identification: Consultation for Air Quality Integrated Science Assessment for Particulate Matter (PM) - Toxicologic Studies of PM Cardiovascular Effects II. Period of Performance: Date of Award - September 30, 2009 III. Type of Purchase Order: Firm Fixed Price (inclusive of all travel costs and fees) IV. Estimated Level of Effort: 363 hours for Tasks 1-7 (148 hours for Optional Task 8-10) INTRODUCTION The Clean Air Act requires periodic review of the National Ambient Air Quality Standards (NAAQS). As 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) review and integrate new scientific information on the pollutant 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 (71 FR 61144, October 17, 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 at 15 ?g/m3. The Agency also retained the existing national 24-hour PM10 standard of 150 ?g/m3, while revoking the annual standard for PM10. 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 meeting in Fall 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 by using discipline-specific (i.e., epidemiology, toxicology, 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 release of an external review draft for public comment and CASAC review. The EPA anticipates preparing two drafts of the PM ISA for public and CASAC review, before completion of the final PM ISA. NCEA is seeking to retain the professional services of scientists to assist with the review, critical evaluation, summary, and integration of the available scientific database on PM health effects. Under this order, the EPA seeks the professional services of an expert scientist(s) to accomplish the tasks described in the statement of work, with respect to assessing PM cardiovascular effects in laboratory animals, cell culture, and assay systems. 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 the 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 will be reviewed by the EPA Project Officer (PO) and the Quality Assurance Manager 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 an order. The expanded outline shall provide a clear presentation of the scientific issues (see Attachments 2 and 3) and identify some preliminary key studies to be discussed in the cardiovascular toxicology section of the ISA and annexes. The intent of the outline is to ensure that the Contractor has a clear understanding of the specified technical direction and guidelines for completion of this section. Task 2. PARTICIPATE IN PRELIMINARY MEETING FOR AUTHORS The EPA PO will hold a teleconference to assess the current understanding of PM and the expanded outline provided by the Contractor (Task 1). The Contractor shall participate in the teleconference. This meeting will be an opportunity for interaction among authors and EPA in the initial stages to develop 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, authors, and contributors who may participate in the development of the PM ISA and annexes. The meeting is intended to provide the Contractor with important scientific guidance in fulfilling their respective responsibilities/tasks and to raise and address issues (see Attachments 2 and 3) of importance in assessing the cardiovascular toxicology of PM exposure. It will also provide Contractors with a clear understanding of the nature and time schedule of the PM ISA preparation. The meeting is tentatively scheduled to take place within 2 weeks after award. The Contractor shall be notified of the exact date of the meeting within a few days after award by the PO. Task 3. PREPARE WRITTEN SECTIONS ON THE TOXICOLOGY STUDIES RELEVANT TO THE CARDIOVASCULAR EFFECTS OF PM FOR THE ISA The Contractor shall prepare a text section (document) for the PM ISA that concisely reviews the most relevant published scientific evidence on the cardiovascular effects of PM. The Contractor shall address the issues outlined in Attachment 2, based on literature available since completion of the previous PM AQCD. In addition to the text section, the Contractor shall prepare tables that summarize all newly published studies on the assigned topic only if Task 8 (listed below) is exercised. A proposed outline of all the general topics in the annex on toxicologic effects of PM exposure is included in Attachment 3. 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 PM effects on the cardiovascular system at the time of the writing of the 2004 PM AQCD and the 2006 Provisional Assessment of Recent Studies on PM. Key conclusions forming the basis for current criteria shall be presented and established for framing the discussion of new studies and issues. (2) The Contractor shall perform a detailed literature survey of all new peer-reviewed, published (or accepted for publication) articles, books, and reports that present data and information on PM cardiovascular effects 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, type of search engines, and limits placed on the searches. The basis used for selecting cardiovascular literature for the present assessment includes whether a given study includes sufficient information on: " particle type and collection or generation method; " analyses of effects of specific PM or indicators related to PM sources (e.g., combustion-related particles) and/or size fractions; " PM dose/concentration levels; " exposure method and system (i.e., whole-body inhalation, cell culture, etc.); " exposure duration; and " analysis methods. If any of the above are insufficiently characterized in the manuscript, such that making appropriate conclusions is difficult, that study should not be further considered for the integration and synthesis portion of this Task (Subtask 4). The Contractor shall fully document the study selection criteria for inclusion and provide explanations as to why a study has been omitted from the PM ISA animal toxicological cardiovascular section (i.e., how it "failed" the selection criteria). (3) The Contractor shall determine the relative quality of PM cardiovascular studies identified in Task 3, Subtask 2. Emphasis shall be placed on the PM cardiovascular studies published since the previous PM AQCD that evaluate the (1) effects of PM at doses or concentrations that are reasonable compared to ambient levels (<20 times the highest ambient concentrations observed), (2) potential mechanisms of cardiovascular effects, and/or (3) PM sources, components, or other characteristics that may be responsible for these cardiovascular effects. Those studies employing granular dusts (e.g., carbon black, titanium dioxide, etc.) or minerals (e.g., quartz, feldspar, mylonite, etc.) should be included only for comparison purposes, as these particle types are often laboratory derived and/or found in trace quantities in ambient PM. In addition, those studies employing only gaseous components of diesel exhaust (e.g., 2-nitrobenzanthrone, benzo(a)pyrene, nitrophenols, etc) will be excluded. Studies that include these compounds as part of an ambient PM mixture should be included. Studies that utilize man-made nanoparticles should also be excluded. The following considerations shall be taken into account for each identified study: " If the cardiovascular parameter and endpoint measurements were meaningful and reliable. " If the methods and analyses employed were appropriate, well performed and properly interpreted. " If important study design limitations were appropriately controlled or acknowledged. " If the reported findings were internally consistent, biologically plausible, and coherent with other known facts and/or studies. (4) The Contractor shall perform a balanced and objective evaluation that summarizes, interprets, and synthesizes the most important studies and issues in the toxicologic literature on cardiovascular effects of PM. As appropriate, older studies (i.e., those published prior to the last PM ACQD) may be referenced and cited to support new study findings. To the extent possible, this review should expand upon the cardiovascular toxicology discussion in the 2004 AQCD for PM and bring forward new study results with different PM components or sources. For PM components and sources that have numerous studies (e.g., diesel emissions and fractions), only those studies providing the strongest evidence shall be discussed, with other studies providing complementary and supplementary information. The Contractor shall rely upon his or her expertise in the cardiovascular field to determine the most appropriate studies for discussion. Those studies included in the discussion shall be described in the context of their findings and how they relate to the five bulleted points below; specific details on the methodology of these studies shall only be included when necessary (i.e., novel animal model, significant limitations, etc.). However, these study details may be included in a summary table or figure. Newly created or appended previously published tables and figures will be utilized in the discussion. The Contractor shall present observations and conclusions for cardiovascular PM findings. The following points shall be discussed in the synthesis text: " integration of new PM cardiovascular literature; " interpretation of cardiovascular results in the context of previous PM documents and literature; " possible mechanisms and pathways responsible for the observed cardiovascular effects; " coherence of cardiovascular effects across similar particle types, components, and/or sizes; and " consistency of cardiovascular effects across in vivo and in vitro study types. 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 public health perspective and identify new issues and literature as appropriate. The Contractor shall develop this work product for the ISA annex to form the basis for the development of the ISA, a concise focused assessment that addresses the issues identified and provides the foundation for the PM NAAQS. The Contractor shall provide EPA with a copy of all journal articles referenced and include a thorough bibliography of references. Task 4. REVIEW AND EVALUATE THE PM ISA AND ATTEND THE PEER REVIEW WORKSHOP FOR THE DRAFT The first draft of the PM ISA shall be reviewed by all authors, external peer reviewers, and relevant NCEA staff at the peer review workshop. A workshop will be held to discuss reviewer comments. Subtasks (1) The Contractor shall review and provide written comments on the health material relevant to his/her toxicological discipline of the review draft. A draft of the relevant section(s) will be provided to the Contractor by the PO two weeks in advance of the event. (2) The Contractor shall attend the peer review workshop to discuss his/her specific draft section(s) of the PM ISA. The workshop is expected to take place in March/April 2008 and to last approximately two days. The Contractor shall be present during the period that covers review of the areas of the ISA for which their active participation is needed. The workshop will be convened to review the draft ISA to ensure that issues pertinent to review of the PM NAAQS are brought into the ISA and that all relevant, new literature has been identified. An advance notice of the specific dates for the peer review workshop will be provided to the Contractor by a written notification issued by the EPA PO and copied to the EPA Contracting Officer (CO), 30 days in advance of the event. Task 5. REVISE THE SECTIONS IN RESPONSE TO COMMENTS RECEIVED AT THE PEER REVIEW WORKSHOP The Contractor shall submit any revisions on his/her section(s) based on recommendations resulting 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 author inputs, the EPA will process the various sections to produce a unified word processed version that includes text, figures, tables, and references. On the technical aspects, the EPA first examines the text for quality control and implements appropriate revisions and then integrates the material across section, chapter and document, including interpreting the overall available information. The EPA thus assumes primary authorship 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 draft ISA. The Contractor shall be available to assist in the development and synthesis of the ISA. This draft ISA 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 In preparation for the CASAC review meeting, the Contractor shall be prepared to participate in the discussion on the contents of the document. In particular, the Contractor shall be prepared to participate in the discussion on his/her section. The Contractor shall also read any public comments received on this section that are supplied by the EPA PO and shall be prepared to provide a preliminary oral response to those comments. Comments will be provided to the Contractor as available before the CASAC public meeting. The Contractor shall attend and participate in the public meeting conducted by the CASAC that will review the first external draft of Integrated Science Assessment for PM. The CASAC public meeting will be held in Research Triangle Park, NC, and is expected to last approximately 2-3 days. The Contractor shall be notified of the exact schedule for the meeting by a letter from the EPA PO, at least 30 days in advance. OPTIONAL TASKS The Government may elect to exercise one or more of the optional tasks listed below. The Contractor shall not perform any work associated with the optional tasks below (Tasks 8, 9 or 10) until a written modification is received from the EPA CO stating that one or more of the optional tasks has been exercised and funded accordingly. Optional tasks will be exercised on as needed basis. Task 8. PREPARE ANNEX TABLES FOR PEER REVIEW MEETING AND REVISE PM ANNEX TABLES IN RESPONSE TO COMMENTS RECEIVED FROM PEER REVIEW MEETING This notice of intent is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to the requiring by submitting documentation, to Thomas Martinez at the office identified above, by e-mail (martinez.thomas@epa.gov) , which establishes that their specifications meet EPA's requirement. Documentation must be received within fifteen (15) days after the date of publication of this synopsis to be considered by EPA. A determination not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Inf
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