Mission Support Services for the Preparation of Toxicological Profiles
Added: Nov 02, 2017 10:27 am
Title: Mission Support for the Preparation of Toxicological ProfilesIntroductionThis is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The NAICS code for this acquisition is 541690, Other Scientific and Technical Consulting Services, with a size standard of $15 million dollars.BackgroundThis procurement is entitled Mission Support Services for the 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 17th of each year.Scope of WorkThe objective of this procurement is to develop an Indefinite Delivery, Indefinite Quantity (IDIQ) contract 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, technical assistance, 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.Purpose and ObjectiveUnder 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 RequirementsATSDR requires the following technical and general requirements:Technical Requirements1. 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, prepared in accordance with the guidelines provided by the Government, and should incorporate a systematic review approach.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, and Chemical Evaluations when determined by the Government as needed.General Requirements Develop scientifically accurate toxicological profiles and associated documents.1. The contractor shall also perform the tasks specified below. This work shall be performed in accordance with the (1) "The Outline for the Preparation of Toxicological Profiles," (Attachment A) and (2) "Guidance for the Preparation of a Toxicological Profile" (see link in C.8.) except where the ATSDR CORs have agreed with the contractor to a variation in the guidance for a given substance. The guidance document shall be used in conjunction with other guidance utilized in risk assessment, (e.g. benchmark dose modeling), as necessary in the MRL derivation process.2. The contractor shall conduct a literature search (Attachment B) and acquisition, prepare the supplemental document, prepare Chapters 1 (Public Health Statement), 2 (Relevance to Public Health), 3 (Health Effects), 4 (Chemical and Physical and Information), 5 (Production, Import/Export Use and Disposal), 6 (Potential for Human Exposure), 7 (Analytical Methods), 8 (Regulations and Advisories), 9 (References), 10 (Glossary), and Appendices. The contractor shall also prepare Levels of Significant Exposures (LSE) Tables and Figures, propose MRLs and prepare MRL worksheets for each of the hazardous substances that is profiled. The contractor shall utilize the most current EPA methodologies in calculating entries for the supplemental document, profile, LSE tables/figures, and appropriate MRL derivation.3. The quality criteria that will be applied to the work products are outlined in Attachment C.4. Develop the profile under the specific criteria of the Government as specified in the Guidance Document and Exhibits for Toxicological Profiles available online at i. http://www.atsdr.cdc.gov/toxprofiles/guidance/profile_development_guidance.pdf and http://www.atsdr.cdc.gov/toxprofiles/guidance/set_21_guidance_exhibits.pdf. These documents provide specific guidance on the content and organization of the toxicological profile. The general outline of the profile will be as outlined in attachment A.5. Develop two drafts and a final camera ready draft for the pre-public comment phase and for the post-public comment phase as specified in the deliverable tables. Please note that interim drafts may be required. A minimum time frame of 4 weeks will be given to the Government to review each draft and provide comments. Develop a camera ready pdf copy suitable for posting on ATSDR website. All files should be compliant with electronic and information technologies, section 508 of the Rehabilitation Act of 1973 (http://www.section508.gov).6. Anticipate the need and coordinate the delivery of all necessary drafts of profiles, updates, and reports for peer review with the ATSDR Office of Science liaison and integrate the products of that peer review into the schedule for document development, and provide a formal disposition of peer reviewer comments for approval by the Government.7. The contractor may be required to travel to CDC/ATSDR project offices to meet on science panel or other meetings or reviews on draft and final profile reports or for conferences regarding the performance of work under the contract, as determined by the Government.Anticipated Period of PerformanceThe Period of Performance is estimated to be 60 months from the date of award.Other Important ConsiderationsNoneCapability StatementsInterested Offerors should submit a capability statement specifically addressing the criteria listed below only. Capability statements that address requirements other than what is identified below will not be reviewed. The information requested below is the only information the government will review in response to this sources sought notice. Therefore, please explain, in detail, your experience, knowledge and ability to provide the following:• Your opinion about the difficulty and/or the feasibility of the potential requirement or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace and information regarding innovative ideas or concepts.• Your staff expertise, including their availability, experience, formal training and any other training.• Your current in-house capability and capacity to perform the work.• Your prior completed projects of similar nature.• Your corporate experience and management capability. Provide any examples of prior completed Government contracts, references and other related information.• Provide any other information that may be helpful in developing or finalizing the acquisition requirements.Information Submission InstructionsPlease include cover pages with the following business information. The cover pages do not count against the page limit for the capability statement.• DUNS Number• Organization name, address and point of contact.• Do you have a Government-approved accounting system? If so, please identify the agency that approved this system.• Business size and type of business (e.g., small business, 8(a), woman-owned, veteran-owned, etc.) pursuant to the applicable NAICS code 541690 and size standard of $15 million dollars.• Technical and administrative points of contact including name, title, address, telephone number and email address of the individual(s) who can verify the demonstrated capabilities identified in the response.• In your opinion, is NAICS code 541690 appropriate for this requirement? If not, which NAICS code is most applicable and why?Page LimitationsCapability Statements shall be limited to ten (10) pages (including references, appendices, charts, illustrations, diagrams and resumes). The cover page does not count against the page limit. Pages shall be single-spaced and formatted as follows: MS Word, 8 ½ x 11, 12-Point Times New Roman font with one (1) inch margins.Preparing ResponseRespondents are cautioned that "standard" marketing brochures may not provide sufficient and specific information to enable the government to evaluate an offeror's capabilities relative to the requirement discussed above. Therefore, offerors should tailor their capability statement to specifically address the questions noted above.Response Due DateSubmit capability statements via email to Tonya S. Justice, Contracting Officer, at wzo1@cdc.gov. Should you have any questions concerning this sources sought, please direct your questions in writing to Tonya S. Justice, Contracting Officer at wzo1@cdc.gov. The Government will not respond to oral questions. Responses must be submitted no later than 10:00am, Eastern Standard Time (EST) on November 16, 2017. Capability Statements will NOT be accepted after the response due date. No telephonic or facsimile responses will be accepted. The Government will not provide any feedback on capability statements and will not return capability statements received.Disclaimer and Important NotesThis notice does not obligate the Government to award a contract or otherwise pay for any information provided in the 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 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. Responses received to this sources sought notice will not be considered as adequate responses to a solicitation.ConfidentialityNo 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).
2018-N-67631 Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services
11/2/17, 10:27 AM