SOURCES SOUGHT
B -- Toxicological Profiles Project
- Notice Date
- 2/1/2013
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2013-01-29
- Archive Date
- 3/8/2013
- Point of Contact
- Vallerie M Redd, Phone: 770-488-2845
- E-Mail Address
-
gfj3@cdc.gov
(gfj3@cdc.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background. This procurement is entitled Mission Support Services for Preparation of Toxicological Profiles and Associated Documents. Profiles are developed in response to the Superfund Amendments and Reauthorization Act (SARA) of 1986 which amended the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund). Under the authority of Section 104 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Section 104, as amended by Section 110 (P.L. 99 499) of the Superfund Amendments and Reauthorization Act of 1986 (SARA), the Agency for Toxic Substances and Disease Registry (ATSDR) and the Environmental Protection Agency (EPA) are required to establish guidelines for the development of toxicological profiles. The development of toxicological profiles and other scientific documents continue to support federal, state and local health professionals, public health assessors, and numerous groups and individuals in understanding the potential for human exposure to various hazardous substances. Profiles are required to be released by October 17 of each year. Purpose and Objectives. The purpose of this procurement is to support ATSDR in the preparation of profiles and associated documents on hazardous substances found at facilities on the EPA National Priorities List. Substances for profile development are selected from the ATSDR Substance Priority List (http://www.atsdr.cdc.gov/spl/index.html). Other substances not on the list may also be selected based on the public health needs as determined by ATSDR. Support provided under this procurement may include coordination of the production of the profile, as well as analysis, consultation, support concerning projects directly related to the development of the profiles and significant human exposure levels (SHELs) or Minimal Risk Levels (MRLs) and other scientific documents. The profile must also focus on important data needs that preclude the determination of significant levels of human exposure or contribute substantially to the uncertainty of such levels. The quality of such data must be assessed and in order to support the determination of levels of significant human exposure and, where major gaps in the supporting data exist, identify those data needs in the toxicological profiles. Under Section 104 of CERCLA as amended by Section 110 of SARA, the toxicological profiles must contain, at a minimum, the following information: An examination, summary, and interpretation of available toxicological information and epidemiologic evaluations on a hazardous substance in order to ascertain the levels of significant human exposure for the substance and the associated acute, subchronic, and chronic health effects. A determination of whether adequate information on the health effects of each substance is available or in the process of development to determine levels of exposure which present a significant risk to human health of acute, subchronic, and chronic health effects. Where appropriate, an identification of toxicological testing needed to identify the types or levels of exposure that may present significant risk of adverse health effects in humans. Under the provisions of CERCLA, Section 104 as amended by SARA, Section 110, ATSDR has sole responsibility for the development and publication of all toxicological profiles and will sponsor the work and serve as project oversight. In addition, the profile will undergo an independent peer review and be made available in draft form to the public for comment. ATSDR will be referred to as the Government in the work requirements. Project requirements. Scope of Work - 1. Conduct the review and develop evaluations of available research and analysis in specific subject areas. Examples of such subject areas include quantitative structure activity relationship (QSAR) modeling, physiologically based pharmacokinetic (PB-PK) modeling, analysis of the toxicity of mixtures, benchmark doses, and toxicity equivalence factors. Included in this objective is the search for and retrieval of literature for the Government related to such review and analysis. This retrieved literature may be required to be provided to the Government on request. 2. Coordinate the production of drafts and camera ready final profiles and associated documents for each substance in accordance with the guidance and specifications issued by the Government. 3. Support the Government in the assessment of data deficiencies/gaps or needs that preclude the determination of levels of significant human exposure or contribute to the uncertainty of such levels. 4. All such Government directed work by the contractor shall be of high scientific, technical, and editorial quality, uniformity, and consistency, and prepared in accordance with the guidelines provided by the Government. 5. Peer Review services will be coordinated with a liaison to the ATSDR Office of Science. It will be the responsibility of the contractor to anticipate the need for and coordinate the delivery of all necessary drafts of profiles, updates, and reports for peer review with the liaison and integrate the products of that peer review into the schedule for document development and to respond to all peer reviewer comments, as scientifically appropriate, and to provide a Disposition of Peer Reviewer Comments report outlining, by individual peer reviewer, how each comment was addressed. Typically three (3) peer reviewers are selected per profile, however, special circumstances may require more than three. 6. The contractor will be required to respond to all public comments submitted for each profile and to provide a Response to Public Comment Report which outlines each public comment, identifying the submitter, and the response as to how the comment was addressed in the profile. 7. The contractor will prepare ToxFAQs (English & Spanish), ToxGuides, and stand-alone Public Health Statements (English & Spanish). The contractor may also be required to prepare Priority Data Needs (PDN) documents, Medical Management Guidelines (MMG) documents, Case Studies in Environmental Medicine, Chemical Specific Consultations, Chemical Evaluations when determined by the Government as needed. Technical Requirements - Contractor specific tasks will include but are not limited to the following: 1. The contractor shall maintain a profile and report tracking and monitoring system for contractor internal use to serve as a control for progress on profile and report development. The Government will review progress on all work through inspection of that system on a routine basis. 2. The contractor shall conduct literature searches and retrievals for specified topics as outlined in the guidance for the preparation of toxicological profiles. Prior to retrieval of "non-local" papers, the contractor should consult with the COR to coordinate the most cost effective process. 3. The time frame for the literature searches will be such that will capture the pertinent literature that was made available since the time the previous profile was released (in the event of developing an update profile), such that no time gap of information exists between the information since the previous release and the first and subsequent drafts of the profile. 4. The contractor shall analyze and provide written reports of analysis of the literature or specified data sets. This analysis may include the manipulation of data related to the prioritization of hazardous substances found at NPL sites. 5. The contractor shall provide electronic copies (unless prevented due to copyright) of all references cited in profiles and related documents using a reference management program such as Endnote (www.endnote.com) or other suitable method. The contractor shall coordinate the development of and provide to the Government supplemental documents, which summarize and evaluate each study reviewed for the development of a profile or update. Guidance for the development of the supplemental document is provided with the guidance for the toxicological profiles, and may be changed through discussions between Contracting Officer's Representative (COR) and contractor. 6. The contractor shall coordinate the development of and provide to the Government a first draft of specified sections of a profile, update, or report for each substance. The drafts of these sections will be prepared and delivered to the Government in the order specified by the Government. The contractor shall provide these first drafts to the Government at the time prescribed. 7. The contractor shall coordinate the development of and provide to the Government a complete draft of each profile, update, or report based on comments and discussions with the Government in response to the first draft of specified sections of the profiles, updates, or reports. 8. The contractor shall provide a complete draft or specified sections of each profile, update, or report for peer review at the time prescribed in the schedule described in tables 1 and 2. Contractor shall assure that the Government and the peer review manager have convenient access to all necessary studies for the conduct of the peer review 9. The contractor shall coordinate with the ATSDR Office of Science liaison the peer review process and determine whether the literature cited in the reports requires updating in response to the peer review. 10. The contractor shall coordinate the development of and provide a subsequent draft of profiles, updates, or reports to the Government in response to the peer review, and in response to comments by other reviewers designated by the Government. 11. The contractor shall meet with the Government for review of any draft of the profiles, updates, or reports as directed by the Government. 12. The Government may direct the contractor to incorporate peer review into any additional profile drafts or sections. 13. Word processing CD ROMs that allow exact duplication of any and all materials with ATSDR's systems shall be provided with each draft profile. Also the contractor must have the capacity to provide some documents in other electronic formats (i.e., WORD, FileMaker, PageMaker, Rich Text Files, HTML, XML, and 508 compliant PDF). 14. The contractor shall coordinate with the Government and use the EZ-Tox database to create and generate supplemental documents. 15. The contractor shall submit a final camera-ready draft of each profile and associated documents to the Government for approval, as specified in the schedule of deliverables. 16. The contractor shall participate in Science Panel Review/Minimal Risk Level Workgroup meetings. Anticipated period of performance. Base Period: 7/1/2013 - 6/30/2014 Option Period 1: 7/1/2014 - 6/30/2015 Option Period 2: 7/1/2015 - 6/30/2016 Option Period 3: 7/1/2016 - 6/30/2017 Option Period 4: 7/1/2017 - 6/30/2018 Other important considerations. None. Capability statement /information sought. All respondents must provide a capability statement. The capability statement must include the following: 1. Technical and Business Content: i) information regarding respondents': (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information; and ii) technical and business content shall not exceed 10 pages. 2. Cover Page and Table of Content: i) information regarding respondents' DUNS number, organization name, address, technical and administrative points of contact including names, titles, addresses, telephone and fax numbers, and e-mail addresses, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code; and ii) Cover Page and Table of Contents shall not exceed 2 pages and it is not a part of the page limit for the technical and business content. 3. Formatting and Delivery Instructions: i) information shall be provided electronically only (telephone and facsimile responses will NOT be accepted) to the Contracting Officer, Vallerie Redd, at gfj3@cdc.gov ; ii) information should be provided in Microsoft Word (.doc) or Adobe PDF, font size must be greater than 10 pitch, paper size must be 8 ½ X 11, margins must be greater than 1.0, spacing should be single or double space; and iii) one copy of the response is required by the Response Date shown above. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2013-01-29/listing.html)
- Place of Performance
- Address: Contractor's Facility, United States
- Record
- SN02978394-W 20130203/130201234939-ba8e9a941c7306c00d788d10382d0a9d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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