MODIFICATION
A -- PATHOPHYSIOLOGICAL PROGRESSION AND RELATIONSHIPS FOR SELECTED ENDPOINTS
- Notice Date
- 8/22/2006
- Notice Type
- Modification
- Contracting Office
- Environmental Protection Agency, Specialized Service Center/Cin. Proc. Operations Div., 26 West Martin Luther King Drive, Cincinnati, OH 45268
- ZIP Code
- 45268
- Solicitation Number
- RFQ-OH-06-00208
- Response Due
- 8/25/2006
- Archive Date
- 9/25/2006
- Description
- NAICS Code: 541710 Pathophysiological Progression and Relationships for Selected Endpoints Amendment #1 Technical Questions Question #1: It is noted in the background that this will serve as preliminary work for the development of a pathophysiological progression model to characterize toxicity endpoints used in human health assessments. Will this be a single request or are similar follow up requests envisioned by the EPA? Answer: The EPA expects further requests, but those requests are dependent on the results from this preliminary project. Question #2: What number of "critical effects" does the EPA anticipate will be identified from the chemical toxicity assessment databases (Task 2)? Answer: The EPA has not identified a specific number at this point. The EPA would rather narrow down a number of effects after initial identification based on the availability of data on pathophysiological progression to adversity of specific effects (5 fully characterized effects would be acceptable at a later stage following identification of effects). Question #3: Is it anticipated that a decision will be made between the EPA and the offeror as to the number of critical effects on which a progression model will be formulated and is there a decision process by which "critical effects" will be prioritized? Answer: The decision of the number (5 offered as tentative, although there may be more effects of interest), as well as the prioritization criteria will both be made between the EPA and the offer, after award of an order. The due date for quotes has been extended. Offers shall submit 1 copy of their quotation that references RFQ-OH-06-00208, no later than August 28, 2006 at 3:00 PM (EST) to Scott A. Fogle, at fogle.scott@epa.gov or via fax at 513 487-2107. Email is the preferred method. Pathophysiological Progression and Relationships for Selected Endpoints This is a combined synopsis/request for quote (RFQ) for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. The identifying RFQ number is RFQ-OH-06-00208. The RFQ and incorporated provisions/clauses are those in effect through Federal Acquisition Circular 05-11. This requirement is 100% set-aside for small businesses. The NAICS code is 541710, and the SBA size standard is 500 employees. I. Project Identification: Pathophysiological Progression and Relationships for Selected Endpoints II. Period of Performance: Award date to December 15, 2007 III. Estimated Labor Hours: 540 hours Background The Environmental Protection Agency (EPA), Office of Research and Development (ORD), National Center for Environmental Assessment (NCEA) is currently developing methodologies and information sources to use as guidelines for acute exposure to various compounds, including air toxics. Overall, this project is being proposed as a means to advance the science that may be utilized in making estimates of safe exposures with special focus on inhalation exposure scenarios. The goal of this project is to identify/categorize toxicological endpoints along a pathophysiological continuum. This will serve as preliminary work for the development of a pathophysiological progression model to characterize toxicity endpoints used in human health assessments. An endpoint is defined in this document as an objective or subjective (e.g. self reported symptoms in a study using human research subjects) measure that serves as an indicator of a response (normal and/or pathological) to chemical/toxicant exposure. A compendium containing the categorization of endpoints along a pathophysiological continuum (from no effect to adverse effect) would serve to do the following: (1) Weigh the relative importance of effects induced by a chemical or across chemicals, (2) Provide information valuable in the determination of species sensitivity and relevance of animal effects to humans, (3) Provide interpretative, descriptive and graphical information that can aid in the standardization and uniformity of chemical health assessments, and (4) Serve as a reference source for chemical-mode of action (MOA) characterization. Tasks The contractor shall complete the tasks below in accordance with the delivery schedule. Task 1. Preparation of Joint Quality Management (JQM)/Quality Assurance Project Plan (QAPP). The contractor shall prepare, submit and adhere to a (JQM/QAPP) specifically designed for this requirement in accordance with the template in Appendix A. The JQM/QAPP shall be submitted to the EPA Project Officer for review and approval. Task 2. Identify the most prominent critical effects available in chemical assessment databases The Contractor shall search chemical toxicity assessment databases, identifying the critical effects within those assessments, and deriving a list of those biological endpoints used as critical effects, (i.e., those toxicological endpoints on which the assessment is based). A severity categorization report (attached) is provided as an example of similar type of database analysis and integration. Task 3. Populate the Pathophysiological Progression Model diagram with the endpoints obtained from task 2, and elaborate on alternative severity categorization paradigms The contractor shall place the critical effects identified in task 2 along a severity continuum using the Pathophysiological Progression Model (Figure 1). The Pathophysiological Progression Model shall be used as the model to be populated with the critical endpoints selected from the chemical toxicity databases. The contractor shall proceed to provide scientific rationale for the placement of specific critical endpoints along this diagram. (Figure 1) Pathophysiological Progression Model Task 4. Provide a series of charts with detailed information on the endpoints as in Task 3, and criteria for placement along the Pathophysiological Progression Model The contractor shall generate a descriptive elaboration of the rationale for the categorization scheme in task 3, along with tabular and graphical representation of the data. For example, columns can be generated within tables for critical effects, temporal or dose association identified, categorization rationale, etc. Task 5. Produce a final report with recommendations for further analysis The contractor shall produce a final report describing the approaches used to identify and categorize the critical effects selected along the Pathophysiological Progression Model. The contractor shall provide recommendations for further analysis for the development of criteria to characterize pathophysiological processes, and identify data rich pathophysiological processes as candidates for future case study(ies). Identification and proposal of alternative severity categorization schemes shall also be addressed. In summary, the final report shall contain an introduction to the issue, approach used for obtaining and analyzing the information, graphical and tabular representation of the data and recommendations for alternative approaches and further data analysis Task 6. Produce an abstract and presentation to be delivered by the EPA at a Scientific Meeting in December 2007. The contractor shall produce a series of slides that summarize the contents of the final report which will be submitted for presentation at scientific meeting, and used as a general presentation for the Pathophysiological Progression Project. Travel by contractor staff will be required in support of this task. The travel location will be determined at a later date. The travel location will be in the U.S. Upon completion of the travel, the contractor shall generate and submit to the PO, a detailed Contractor Travel Report, within (5) working days of completing the travel. DELIVERABLES SCHEDULE The Contractor shall provide written products to the Project Officer 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 provide all written materials and responses in both hard copy and electronic format. Hard copies of all completed text, tables, and figures shall be submitted to Project Officer for review and approval. Authors shall also submit word processing disks or email electronic files. Estimated Delivery Schedule The Contractor shall deliver all written materials and professional services in accordance with the following time schedule: Tasks Dates Task 1. Prepare and Submit detailed JQM/QAPP 2 weeks after award of an Order Task 2. Prepare and Submit Information Required 1 month after approval of QAPP Task 3-4.Submission of Interim Report 5 months after award of an Order Task 5-6. Submission of Final Report, 9 months after award of an Order ***Note: Due to the length of the SOW, Technical Evaluation Criteria, and Attachments (Appendix A., The Severity Categorization Report, and Figure 1) the EPA could not post the entire information to the Fed Biz Ops website. If an offeror is interested in this requirement, please submit a request in writing via email to Scott Fogle at fogle.scott@epa.gov requesting an electronic copy of the Technical Evaluation Criteria and Attachments. All requests for these documents need to be submitted by close of business August 21, 2006. After the responses have been evaluated against the factors above, an order is expected to be placed with the offeror that represents the Best Value to the Government. Price may not be the determining factor. The following clauses apply to this request for quote: FAR 52.212-1, Instructions to Offerors-Commercial Items; FAR 52.212-2 Evaluation-Commercial Items, and the specific evaluation criteria: (See Technical Evaluation Criteria attachment) Offers shall provide information to demonstrate/substantiate that its quote meets the requirements in the Statement of Work; FAR 52.212-3, Offeror Representations & Certifications-Commercial Items, shall be completed by offeror and submitted with quote, unless the offeror's registered with CCR; FAR 52.212-4, Contract terms & Conditions-Commercial Items; The following FAR clauses in paragraph (b) of FAR clause 52.212-5, Contract Terms & Conditions Required to Implement Statutes or Executive Orders-Commercial Items will apply, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.225-13. FAR 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration; all clauses can be found at: http://farsite.hill.af.mil/VFFARA.HTM. In addition, the following US EPA EPAAR clause is applicable to this RFQ: EPAAR 1552.233-70, Notice of Filing Requirements for Agency Protests, and 1552.211-79, Compliance with EPA Policies for Information Resource Management. These EPAAR clauses are available at http://www.epa.gov/oam/ptod/epaar.pdf. CONFLICT OF INTEREST CLAUSES All offerors, responding to this RFQ, shall certify to the following: 1552.209-72 ORGANIZATIONAL CONFLICT OF INTEREST CERTIFICATION (APR 1984) 1. The offeror [ ] is [ ] is not aware of any information bearing on the existence of any potential organizational conflict of interest. If the offeror is aware of information bearing on whether a potential conflict may exist, the offeror shall provide a disclosure statement describing this information. 2. The following clauses shall apply to any resulting order: ORGANIZATIONAL CONFLICTS OF INTEREST (EPAAR 1552.209-71) (MAY 1994) ALTERNATE I to paragraph (e) (MAY 1994) (a) The Contractor warrants that, to the best of the Contractor's knowledge and belief, there are no relevant facts or circumstances which could give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, or that the Contractor has disclosed all such relevant information. (b) Prior to commencement of any work, the Contractor agrees to notify the Contracting Officer immediately that, to the best of its knowledge and belief, no actual or potential conflict of interest exists or to identify to the Contracting Officer any actual or potential conflict of interest the firm may have. In emergency situations, however, work may begin but notification shall be made within five (5) working days. (c) The Contractor agrees that if an actual or potential organizational conflict of interest is identified during performance, the Contractor will immediately make a full disclosure in writing to the Contracting Officer. This disclosure shall include a description of actions which the Contractor has taken or proposes to take, after consultation with the Contracting Officer, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue performance until notified by the Contracting Officer of any contrary action to be taken. (d) Remedies - The EPA may terminate this contract for convenience, in whole or in part, if it deems such termination necessary to avoid an organizational conflict of interest. If the Contractor was aware of a potential organizational conflict of interest prior to award or discovered an actual or potential conflict after award and did not disclose it or misrepresented relevant information to the Contracting Officer, the Government may terminate the contract for default, debar the Contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract. (e) The Contractor agrees to insert in each subcontract or consultant agreement placed hereunder provisions which shall conform substantially to the language of this clause, including this paragraph, unless otherwise authorized by the Contracting Officer. NOTIFICATION OF CONFLICTS OF INTEREST REGARDING PERSONNEL (EPAAR 1552.209-73) (MAY 1994) ALTERNATE I (JUN 1994) DEVIATION (a) In addition to the requirements of the contract clause entitled "Organizational Conflicts of Interest," the following provisions with regard to employee personnel performing under this contract shall apply until the earlier of the following two dates: the termination date of the affected employee(s) or the expiration date of the contract. (b) The Contractor agrees to notify immediately the EPA Project Officer and the Contracting Officer of (1) any actual or potential personal conflict of interest with regard to any of its employees working on or having access to information regarding this contract, or (2) any such conflicts concerning subcontractor employees or consultants working on or having access to information regarding this contract, when such conflicts have been reported to the Contractor. A personal conflict of interest is defined as a relationship of an employee, subcontractor employee, or consultant with an entity that may impair the objectivity of the employee, subcontractor employee, or consultant in performing the contract work. (c) The Contractor agrees to notify each Project Officer and Contracting Officer prior to incurring costs for that employee's work when an employee may have a personal conflict of interest. In the event that the personal conflict of interest does not become known until after performance on the contract begins, the Contractor shall immediately notify the Contracting Officer of the personal conflict of interest. The Contractor shall continue performance of this contract until notified by the Contracting Officer of the appropriate action to be taken. (d) The Contractor agrees to insert in any subcontract or consultant agreement placed hereunder, except for subcontracts or consultant agreements for well drilling, fence erecting, plumbing, utility hookups, security guard services, or electrical services, provisions which shall conform substantially to the language of this clause, including this paragraph (d), unless otherwise authorized by the Contracting Officer. LIMITATION OF FUTURE CONTRACTING (EPAAR 1552.209-74) (MAR 1994) The contractor, during the life of this order, will be ineligible to enter into any business or financial relationship with or represent any party with respect to opposing or influencing the contents of regulations, policies, rulemaking, or guidance for which it has provided, is providing, or is planning to provide Pathophysiological Progression and Relationships for Selected Endpoints, without prior written authorization from the Contracting Officer. The Government anticipates award, using simplified acquisition procedures, of a purchase order(s) resulting from this solicitation to the responsive/responsible offeror whose quote conforms to the solicitation, and is most advantageous to the Government, price and other factors considered. Offers shall submit 1 copy of their quotation that references RFQ-OH-06-00208, no later than August 25, 2006 at 3:00 PM (EST) to Scott A. Fogle, at fogle.scott@epa.gov or via fax at 513 487-2107. Questions or comments may also be directed to Scott A. Fogle, at 513 487-2049, or at fogle.scott@epa.gov. The last day for Technical Questions is August 18, 2006.
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