ATTACHMENT_J6.docx

RFP #2018-N-67631

ATTACHMENT J6

Performance Work Statement (PWS) Title of Project: Toxicological Profile Preparation for Hazardous Substances and Related Documents

Applicable IDIQ Task Areas This Task Order will be awarded under the Mission Support for the Preparation of Toxicological Profiles IDIQ The Task Order includes the following Task Areas derived from the base IDIQ:

Task Area 1: Literature Review Task Area 2: Pre-Public Comments Task Area 3: Post-Public Comments Task Area 4: Tox FAQs

Section B - Supplies Or Services and Prices/Costs

Title of Project: Toxicological Profile Preparation for Hazardous Substances and Related Documents as described in Section C- Performance Work Statement.

This is a Firm-Fixed-Price Line Item This is a Non-Severable Line Item

Anticipated Period of Performance:

09/10/2018 – 09/09/2021

36 Months

Section B- Price Summary Table

TOTAL CONTRACT PRICE $_______________________

B.2 Type of task order

This is a Firm Fixed Price Task Order

B.3 Non-Personal Services

(a) Personal services shall not be performed under this task order contract. Although the Government may provide sporadic or occasional instructions within the scope of the task order contract, the Contractor is responsible for control and supervision of its employees. If the Contractor (including its employees) believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

(b) The contractor shall comply with, and ensure their employees and subcontractors comply with, CDC Policy titled “Identification of Contractors' Employees and Safeguarding Government Information.” No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. . The contractor is limited to performing the services identified in the contract performance work statement and shall not interpret any communication with anyone as a permissible change in contract scope or as authorization to perform work not described in the contract. All contract changes will be incorporated by a modification signed by the Contracting Officer.

(c) The Contractor shall ensure that all of its employees and subcontractor employees working on this contract are informed of the substance of this clause. The Contractor agrees that this is a non-personal services contract; and that for all the purposes of the contract, the Contractor is not, nor shall it hold itself out to be an agent or partner of, or joint venture with, the Government. The Contractor shall notify its employees that they shall neither supervise nor accept supervision from Government employees. The substance of this clause shall be included in all subcontracts at any tier.

(d) Nothing in this clause shall limit the Government's rights in any way under any other provision of the contract, including those related to the Government's right to inspect and accept or reject the services performed under this contract.

(End of Clause)

B.4 Service Definition (Check One)

|X| Non-Severable Service |_| Severable Service

Section C - Description/Specification/Work Statement Performance Work Statement (PWS) Title of Project: Toxicological Profile Preparation for Hazardous Substances and Related Documents

C.1 Background and Need – This procurement is for the preparation of the Toxicological Profile for Inorganic Mercury 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 CERCLA, as amended by Section 110 (P.L. 99499) of 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.

The purpose of this procurement is to support ATSDR in the preparation of toxicological 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 (www.atsdr.cdc.gov/spl). Other substances not on the list may also be selected based on 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, and 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 that contribute substantially to the uncertainty of such levels. The quality of such data must be assessed in order to support the determination of levels of significant human exposure. Where major gaps in the supporting data exist, those data needs must be identified 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 profiles 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.

C.2 Project Objective: The purpose of this contract is to develop the Toxicological Profile for Mercury and associated documents as mandated by the Superfund Amendments and Reauthorization Act (SARA) of 1986.

C.3 Scope of Work The Contractor shall as an independent organization and not as part of the Government, provide all necessary qualified personnel, labor, facilities, equipment, materials, supplies, supervision, and other incidentals to perform the work described below unless otherwise stated in the Performance Work Statement.

C.4 General Requirements

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 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. The contractor will respond to all peer reviewer comments, as scientifically appropriate, and provide a Disposition of Peer Reviewer Comments report outlining (by individual peer reviewer) how each comment was addressed. Typically three 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 provides a response to each comment.

7. The contractor will prepare ToxFAQs (English & Spanish) and ToxGuides. 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.

C.5 Technical Requirements Develop scientifically accurate toxicological profiles and associated documents.

A. 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.9.) 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.

B. The contractor shall conduct a literature search (Attachment B) and acquisition, prepare the supplemental document, prepare Chapters 1 (Relevance to Public Health), 2 (Health Effects), 3 (Toxicokinetics, Susceptible Populations, Biomarkers, Chemical Interactions), 4 (Chemical and Physical and Information), 5 (Potential for Human Exposure), 6 (Adequacy of the Database), 7 (Regulations and Advisories), 8 (References), and Appendices. The contractor shall also prepare Levels of Significant Exposures (LSE) tables and figures and other tables and figures required, 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.

C. The quality criteria that will be applied to the work products are outlined in Attachment C.

In addition to the above tasks, the Contractor shall perform the specific sub-tasks provided below:

1. 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

2. 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 contact the COR to coordinate this effort. 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.

3. Analyze and provide written reports of analysis of the literature or specified data sets. This analysis may involve a systematic review approach.

4. 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.

5. 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 as directed by the COR.

6. 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 COR in the order specified by the Government. The contractor shall provide these first drafts to the COR at the time prescribed.

7. Coordinate the development of and provide to the COR 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. Provide a complete draft or specified sections of each profile, update, or report to the ATSDR Office of Science liaison at the time prescribed in the schedule described in the tables. Contractor shall assure that the COR and the peer review manager have convenient access to all necessary studies for the conduct of the peer review.

9. Coordinate with the ATSDR Office of Science liaison on the peer review process and determine whether the literature cited in the reports requires updating in response to the peer review.

10. Coordinate the development of and provide a subsequent draft of profiles, updates, or reports to the COR in response to the peer review, and in response to comments by other reviewers designated by the Government. Please note that interim drafts may be required. The contractor shall also respond to clearance comments.

11. Meet with the Government for review of any draft of the profiles, updates, or reports as directed by the Government. The COR may direct the contractor to incorporate peer review into any additional profile drafts or sections.

12. Have the capacity to provide some documents in other electronic formats (i.e., WORD, Rich Text Files, HTML, XML, and PDF), all must meet CDC's Section 508 standards. Word processing electronic files that allow exact duplication of any and all materials with ATSDR's systems will be provided with each draft profile.

13. Coordinate with the Government and use the EZ-Tox database (or comparable datebase) to create and generate supplemental documents.

14. Submit a final camera-ready pre-public comment or post-public comment draft of each profile and associated documents to the Government for approval, as specified in the schedule of deliverables.

15. Participate in Science Panel Review/Minimal Risk Level Workgroup meetings and provide written minutes of the meetings.

16. Provide support for toxicological evaluations and consultations, including: literature searches, chemical evaluations, chemical specific consultations, documents to support emergency response activities, update to Toxicological Profiles and database programming when determined by the Government as needed.

C.6 Reporting Schedule The contractor will be required to provide a monthly progress report which will present a list of deliverables, approved time lines and milestones, problems anticipated or experienced, key events of the month and those projected for the coming month. These events should include profile reports and coordination of peer review schedules, and a narrative of performance in literature review and staff utilization. It must focus on project highlights and present anticipated progress in all facets of the Statement of Work. Required reports shall be submitted to the Government COR.

C.7 Special Considerations Contractor performance and resulting deliverables must adhere to all federal, HHS, and CDC IT security and privacy policies, standards and procedures.

A. All data generated under this contract is the property of CDC.

B. Technical Considerations

INFORMATION TECHNOLOGY (IT) SECURITY

Development or implementation of any federal information system[footnoteRef:1] or any electronic data collection effort conducted in the performance of this contract will be required to complete Security Authorization (also known as “C&A”) prior to operation resulting in an Authority of Operate (ATO) from CDC. The contractor shall be required to complete all security documentation and materials necessary to obtain and maintain an ATO. The contractor shall comply with all applicable HHS, CDC, FISMA, HIPPA, NIST, and other federal policies and regulations in the performance of the security requirements. [1: Defining federal information systems:

“Federal Information System” [40 U.S.C., Sec. 11331]: An information system used or operated by an executive agency, by a contractor of an executive agency, or by another organization on behalf of an executive agency.

“Information System” [44 U.S.C., Sec. 3502]: A discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information.

All information systems developed, implemented, or maintained in support of this contract must adhere to the security controls outlined in the National Institute of Standards and Technology (NIST) Special Publication 800-53, Recommended Security Controls for Federal Information Systems and Organizations (as of the date of the SOW review, the current version can be found at http://csrc.nist.gov/publications/PubsSPs.html) and NIST 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations.

The Contractor must follow the guidance available from NIST and other recognized sources, including:

· NIST Special Publication 800-60, Guide for Mapping Types of Information and Information Systems to Security Categories Vol. 1 (http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol1-Rev1.pdf) and Vol. 2 (http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf).

· NIST Special Publication 800-63, Electronic Authentication Guideline (http://csrc.nist.gov/publications/nistpubs/800-63/SP800-63V1_0_2.pdf)

SOCIAL MEDIA AND OTHER THIRD-PARTY WEBSITE USAGE

Use of any and all third-party[footnoteRef:2] / social media[footnoteRef:3] sites must be approved in advance, and comply with HHS and CDC policies, procedures and best practices (including security and privacy) such as those found at: http://www.hhs.gov/web/socialmedia/ and http://www.cdc.gov/SocialMedia/Tools/guidelines/. Contractor will submit necessary documentation, in cooperation with the Project Officer, to obtain approval through designated CDC Social Media governance, as well as Information Security and Privacy Officers. [2: Third-party websites are Internet-based commercial and other non-CDC information services that offer information gathering, storage and processing services, without the usual contracting mechanisms. Examples include SurveyMonkey, DiscoveryCast and Google collaboration sites.] [3: "Social media are various activities that integrate technology, social interaction, and content creation. Social media uses many technologies and forms, such as blogs, wikis, photo and video sharing, podcasts, social networking, mash-ups, and virtual worlds." U.S. General Administration (GSA)]

CAPITAL PLANNING AND INVESTMENT CONTROL/PROJECT MANAGEMENT

The Clinger-Cohen Act (CCA2) legislatively mandates the prudent management of IT investments. Capital Planning and Investment Control (CPIC) is a continuous and integrated process for managing the risks and returns of information technology (IT) investments. The CPIC process fully integrates with the CDC’s overall budget, finance, acquisition, strategic planning, enterprise architecture, security, and other relevant processes. CPIC also aligns with DHHS Enterprise Performance Life Cycle (EPLC) framework and is used for all IT related decisions.

The contractor will follow the EPLC framework which will provide a standard structure for planning, managing, and overseeing IT projects over their entire life cycle. The framework consists of ten life cycle phases. Within each phase, activities, responsibilities, reviews and deliverables are defined. Templates for the deliverables are available to the contractor after award. Exit criteria are established for each phase and Stage Gate reviews are conducted through CDC’s IT Governance process to ensure that the project’s management quality, soundness, and technical feasibility remain adequate and the project is ready to move forward to the next phase. All IT projects in support of this task must adhere to the EPLC requirements and pass each State Gate as appropriate. More information about EPLC can be found at http://www.hhs.gov/ocio/eplc/.

MOBILE APPLICATION DEVELOPMENT

All mobile applications must comply with CDC-related technical and security standards, processes and procedures as stated in the IT Security section of the RFTOP. In addition, the following considerations should be addressed in the proposal:

· The target platform(s) for the mobile application (e.g. iPhone, iPad, Android, Blackberry)

· Approach to 508 compatibility for the platform of choice

· If the mobile application will be made available in a related platform’s online store (e.g. iTunes, Android Market), the process for making it available in a desired store will be managed by and through CDC, resulting in a CDC branded mobile application. The contractor will also be responsible for ensuring the mobile application complies with all standards and specifications for the desired store.

WEB TECHNOLOLGY

The contractor must follow CDC development standards and use the CDC web template package. The CDC Secure Web Application Coding Guidelines and CDC Template Package can be provided by the CDC Project Officer.

HHSAR Provision, 352.239-73: Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.21, .22, .31, and .41.

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

The contractor must protect the confidentiality of proprietary, sensitive, and Personally Identifiable Information (PII).

C.8 Government Furnished Property No property will be furnished by the government.

C.9 References These documents provide explicit details on the Government requirements for the toxicological profiles and associated documents to be developed.

https://www.atsdr.cdc.gov/toxprofiles/guidance/profile_development_guidance.pdf

Toxicological Profiles are available online at:

www.atsdr.cdc.gov/toxprofiles

Medical Management Guidelines are available online at:

www.atsdr.cdc.gov/substances/ToxEmergency.asp

ToxGuides are available online at:

www.atsdr.cdc.gov/toxguides

ToxFAQs are available online at:

www.atsdr.cdc.gov/toxfaqs (English) www.atsdr.cdc.gov/es/toxfaqs (Spanish)

Public Health Statements are available online at:

www.atsdr.cdc.gov/PHS/Index.asp (English) www.atsdr.cdc.gov/es/phs (Spanish)

Priority Data Needs documents are available online at:

www.atsdr.cdc.gov/pdns/

Substance Priority List www.atsdr.cdc.gov/spl

Criteria for Selecting Toxicological Profiles for Development https://www.atsdr.cdc.gov/toxprofiles/guidance/ATSDR_TP_Selection%20Criteria.pdf

EPA Benchmark Dose Software and Guidance www.epa.gov/ncea/bmds

Attachment A-Outline of Toxicological Profiles Attachment B-Literature Search Strategy Attachment C-Quality Criteria

Governing Laws, Guidelines or Requirements:

Federal laws and guidelines that may have major impact on the requirements of this SOW include:

a. Human Subjects (HHS AP and HHSAR 370.301)

b. Federal Information Security Management Act of 2002 (FISMA).

c. The Privacy Act of 1974 - adequate administrative, operational, and technical security controls must be implemented to prevent unauthorized access to or disclosure of any personally identifiable information (PII) that will be accessed by the contractor

d. Paperwork Reduction Act (PRA) C.10 Deliverables Deliverables and the number of copies of each deliverable required for pre- and post-public comment profiles are identified in Tables 1 and 2. All deliverables will be via electronic format (electronic download or delivery on CD ROM). The contractor shall develop and furnish a milestone schedule for completion of all tasks. Electronic files will be sent to the COR and appropriate chemical managers (as determined through coordination of the COR and contractor).

Should hard copies be required, the contractor will be required to deliver such to the COR at the following address: 4770 Buford Highway (F-57), Building 102, 1st floor, Chamblee, Georgia 30341.

Deliverables Schedule

Table 1a: Deliverables to ATSDR (Pre-Public Comment Profiles)

Crude Response to Public Comments 6 weeks after award

MRL packages for Internal MRL review: MRL rationale statement, MRL Worksheets for each proposed MRL, critical studies, IRIS file

Response to Public Comments Document 4 weeks after delivery of item 1 for Pre- Public Comment.

6 weeks from date of approval of response to public comments

Independent Internal Review

MRL Package for Inter-Agency MRL 4 weeks from date of receiving comments on Draft 1

Disposition of Peer Review Comments 4 weeks from date of receiving comments on draft 3

Final Disposition of Peer Review Comments 4 weeks after receiving comments on Draft 4

All references cited on CD ROM and all deliverables on CD ROM for docket 5-10 days after Government request.

4 weeks after receipt of item 7.

Note: Estimated time to completion may be revised based on ongoing development of an "optimal schedule."

Table 1b : Deliverables to ATSDR (Post-Public Comment Profiles)

Response to Public Comments 6 weeks after start of post-public comment phase

MRL packages for Internal MRL review: MRL rationale statement, MRL Worksheets for each proposed MRL, critical studies, IRIS file

6 weeks from date of approval of response to public comment document

Independent Internal Review

MRL Package for Inter-Agency MRL 4 weeks from date of receiving comments on Draft 1

Disposition of Peer Review Comments 4 weeks from date of receiving comments on draft 3

Final Disposition of Peer Review Comments 4 weeks after receiving comments on Draft 4

All references cited on CD ROM and all deliverables on CD ROM for docket 5-10 days after Government request.

4 weeks after receipt of item 7.

Note: Estimated time to completion may be revised based on ongoing development of an "optimal schedule."

Table 2 - Specific Deliverables Items 1

Item 2 Deliverable 8 - Reference list with all references retrieved and reviewed in preparation of these work products.

Deliverable 9 - All references cited in the profiles.

Deliverable 10 - Supplemental document (PDF and EZTox).

Deliverable 18 – Formal Response to Public Comment Report (if post public comment period) Deliverable 19 - Modification.

Item 3

Item 4

Item 5

Deliverable 48- Formal Disposition of Peer Review Comments Deliverable 49 – Final Response to Public Comment Report (if Post Public Comment)

Item 6

Item 7

Item 8 Deliverable 72 - ToxFAQs *** in English & Spanish and ToxGuides****.

Deliverable 73 - Modification.

Item 9

Deliverable 76 – All references cited on CD ROM and all deliverables on CD ROM for docket.

* Modification = variances in deliverables that may be required due to unforeseen circumstances.

** All electronic literature references should be delivered in EndNote or other similar software. In addition, all web page citations should be printed on the day they are accessed and included in the reference CD.

*** “Standalone” version of ToxFAQs (see http://www.atsdr.cdc.gov/toxfaqs/index.asp).

**** ToxGuides (see http://www.atsdr.cdc.gov/toxguides/index.asp).

CAS=chemical abstract service; CD=compact disk; CM=chemical manager; IRIS=Integrated Risk Information System; MRL=minimal risk level; MSWord=Microsoft Office Word 2016®.

ATTACHMENT A: OUTLINE FOR THE PREPARATION OF TOXICOLOGICAL PROFILES

Title Page (A or B) Version History Foreword A [Pre-public] Foreword B [Post-public] Contributors Contents List of Figures List of Tables

Chapter 1. Relevance to Public Health

Chapter 2. Health Effects

Chapter 3. Toxicokinetics, Susceptible Populations, Biomarkers, Chemical Interactions

Chapter 4. Chemical and Physical Information

Chapter 5. Potential for Human Exposure

Chapter 6. Adequacy of the Database

Chapter 7. Regulations and Guidelines Chapter 8. References

Appendices

ATTACHMENT B

LITERATURE SEARCH STRATEGY

The minimum search strategy for gathering o information in the published literature shall include a review of the following computerized data bases:

Primary Databases Medline CAB (formerly Commonwealth Agricultural database) Toxline TSCATS and TSCATS2 TOXCENTER (via STN) USITC Trade Database Analytical Abstracts

NIOSHTIC

TSCA

NTIS

BIOSIS

EMBASE

Pollution Abstracts Enviroline Chemical Abstracts Food Science and Technology Abstracts

FEDRIP

HSDB

RTECS

IRIS

TOMES

ASTER/AQUIRE

Sequoia

TRI

Fish Advisories

[Note: Other databases may be utilized as approved by the government].

ATTACHMENT C

Quality Criteria

Please note that if the work products for a profile are not accepted by ATSDR, they shall be considered as having been of unacceptable quality. Furthermore, any rejected deliverables will be considered as having missed their due date, and will be so noted in the contractor’s performance report.

The following quality criteria will be applied to the work products received.

1. An ATSDR reviewer will read 16 of the references cited and compare the information in the references with the data attributed to those references found in the Supplemental Document, LSE tables, MRL worksheet(s), the draft of Chapter 2, Chapter 3 and the text and tables of Chapter 5. Fourteen of the references reviewed will be randomly selected from all references cited in Chapter 3 (including references in the currently published version of the profiles that are the subject of updates in the work assignment). The remaining two references will be selected from those cited for Chapter 5. This review will be primarily to confirm the factual accuracy and interpretation of the relevance of the referenced data presented in the Supplemental Document, Chapters 2, 3 and 5, and the MRL worksheets. A reference will be scored as having been inaccurately represented in the profile if one or more discrepancies are found between the reference and any of the work products required by this work assignment. If more than 4 of the 16 references (i.e., 75%) are scored as having been inaccurately represented in the profile, the work products will be rejected.

2. A tree search will be performed by ATSDR. The publications by three authors who appear to be contributors to the toxicology of the substance will be retrieved using electronic databases. In addition, the titles of references cited in three articles will be reviewed to see if relevant articles were considered for inclusion. The purpose of this evaluation is to ensure that publications that could significantly influence the information present are retrieved and reviewed. All references listed by the search will be compared to the reference list provided by the contractor (Deliverable 8). All references that are not in Deliverable 8 will be scored as additional references. For updates, please note that a reference can be scored as additional even if its date of publication precedes the publication date of the old profile. These additional references will be reviewed by ATSDR. If more than one (1) of these additional references found by ATSDR is judged by ATSDR to be applicable to a data need for the substance, or influence the derivation of an MRL for the substance, the work products will be rejected.