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STATEMENT OF WORK

Project Title: Hazardous Substances Data Bank: 1) Primary Record Building:

Substance Identification, Safety and Handling, Toxicity/Biomedical effects, Pharmacology, Exposure Standards and Regulations, Monitoring and Analysis Methods, and Additional References, and 2) Review Panel Support

Background Information

The National Library of Medicine (NLM) develops and maintains the Hazardous Substances Data Bank (HSDB) which is a part of TOXNET, a group of databases covering chemicals, drugs, and other substances (e.g., nanomaterials), diseases and the environment, environmental health, occupational safety and health, poisoning, risk assessment and regulations, and toxicology. HSDB focuses on the toxicology of potentially hazardous chemicals and other substances. It is enhanced with information on human and environmental exposure, industrial hygiene, emergency handling procedures, environmental fate, regulatory requirements, and related areas. All data are referenced and derived from a core set of websites and online databases, books, government documents, technical reports, and selected publications in scientific journals. These resources are evaluated and approved by NLM for HSDB record development.

HSDB is organized into individual substance records, currently contains about 6,000 such records, and is accessible at no cost via NLM TOXNET (https://toxnet.nlm.nih.gov). The draft records for HSDB are peer-reviewed by the Scientific Review Panel (SRP), a committee of experts in the major subject areas in

HSDB.

Purpose and Objectives

The purpose of this procurement is to obtain professional services for HSDB to build new records, enhance and maintain existing records, and to obtain support for database-related activities such as attendance of one or more contractor’s staff, as noted below, at the peer-review meetings associated with review of the draft records.

Proposals responding to this SOW must include approaches regarding substantially improving one or more steps of the HSDB record creation, development, maintenance, and review process. Suggestions about how the process can be enhanced to improve the speed and cost efficiency, including the number of records that are developed and reviewed each year should be detailed.

Each HSDB record contains over 150 data fields organized in ten broad subject areas

(as they appear in the Content Management System/CMS):

1. Substance identification

2. Manufacturing/use information https://toxnet.nlm.nih.gov/

2 | P a g e

3. Chemical and physical properties

4. Safety and handling

5. Toxicity/biomedical effects

6. Pharmacology

7. Environmental fate/exposure potential

8. Exposure standards and regulations

9. Monitoring and analysis methods

10. Additional references

The subject categories are further subdivided into headers and data fields. Each header contains related data fields. The basic unit of information is the data field. Each data field may contain one or more occurrences of information called data statements. Each data field, header, and subject category is associated with a unique two to four letter mnemonic (e.g., HTOX is Human Toxicity Excerpts), used for searching, for contractor and SRP communications and review, and for printing. Occurrences may also have assigned sub-headers or data tags that provide specific information about the occurrence or type of data. A list of the data fields, definitions, and mnemonics is available at https://toxnet.nlm.nih.gov/help/hsdbf.htm. A complete list of substances in

HSDB is available at https://sis.nlm.nih.gov/enviro/hsdbchemicalslist.html. A sample record showing how the data fields are displayed in the table of contents is available at https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/r?dbs+hsdb:@term+@na+permethrin.

“The National Library of Medicine’s (NLM) Hazardous Substances Data Bank (HSDB):

Background, Recent Enhancements and Future Plans” describes many aspects about how HSDB is currently developed and what it contains as records

(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4195797/ ).

The HSDB is built online in an NLM-maintained CMS. This system is also used for the editing, updating, enhancement, maintenance and review steps. The primary contractor participates in each of these activities. The CMS can be accessed and utilized only by authorized contractors, the SRP members, and NLM HSDB staff. Access will be granted post award and requires a username, password, and an additional authentication factor.

NLM project staff will provide login information post award. Data may also be imported from NLM PubChem via FTP.

Specific Tasks/Requirements

The contractor will identify and compile all data and information necessary to populate

Sections 1 (Substance identification), 4 (Safety and handling), 5 (Toxicity/Biomedical effects), 6 (Pharmacology), 8 (Exposure standards and regulations), 9 (Monitoring and analysis methods), and 10 (Additional references). See https://toxnet.nlm.nih.gov/help/hsdbf.htm for a description of HSDB data fields where section titles are listed in boldface and may be expanded to view subsections.

Coordination with the secondary HSDB contractor for Sections 2 (Manufacturing/use https://toxnet.nlm.nih.gov/help/hsdbf.htm https://sis.nlm.nih.gov/enviro/hsdbchemicalslist.html https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/r?dbs+hsdb:@term+@na+permethrin https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4195797/ https://toxnet.nlm.nih.gov/help/hsdbf.htm

3 | P a g e information), 3 (Chemical and physical properties), and 7 (Environmental fate/exposure potential) is necessary. This information is required for new and existing HSDB records needing updates. Access to the NLM-maintained CMS for all data delivery will be given at time of award. To improve efficiency, searches of online resources containing these types of information shall be included, e.g., U.S. EPA’s Computational Toxicology

(CompTox) Chemicals Dashboard (https://www.epa.gov/chemical-research/comptox-chemicals-dashboard) and the National Toxicology Program (NTP) Integrated Chemical

Environment (ICE), https://ntp.niehs.nih.gov/pubhealth/evalatm/test-method-evaluations/comptox/ct-ice/ice.html ).

NLM does not furnish the equipment needed for this work and access is through a secured encrypted network connection.

TASK 1: Create, update, and enhance specified sections of HSDB records

1. Identify and compile all data and information necessary to populate portions of fields related to information in Sections 1, 4, 5, 6, 8, 9, and 10 (the secondary contractor for HSDB will focus its efforts on Sections 2, 3, and 7) including, but not limited to, substance identification, safety and handling, toxicity/biomedical effects, pharmacology, exposure standards and regulations, monitoring and analysis methods, and additional references. Working with the secondary HSDB contractor to seek to avoid duplication of effort and to share useful information that is identified and complied is essential.

2. Efficiently retrieve full text publications, e.g., from online databases, extract portions of the publications for HSDB, and refer to the publications and the extracts during peer review meetings when consulting with subject matter experts and the NLM HSDB team.

3. Summarize the substance identification, safety and handling, toxicity/biomedical effects, pharmacology, exposure standards and regulations, monitoring and analysis methods, and additional references information.

4. Work with NLM staff and the other HSDB contractor to identify substances known to be, or expected to be, hazardous to the public and the environment, including those with a current public and/or Federal Agency desire or need for information.

Enough information shall be sought to support having an HSDB record built or updated. Work with NLM staff and the other contractor to collect and maintain a database(s) for sorting and prioritizing chemicals for selection to be added or updated in HSDB. The other HSDB contractor has the lead for collecting and maintaining this “sorting and prioritizing” database.

https://www.epa.gov/chemical-research/comptox-chemicals-dashboard https://www.epa.gov/chemical-research/comptox-chemicals-dashboard https://ntp.niehs.nih.gov/pubhealth/evalatm/test-method-evaluations/comptox/ct-ice/ice.html https://ntp.niehs.nih.gov/pubhealth/evalatm/test-method-evaluations/comptox/ct-ice/ice.html

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5. Identify and provide substance identification, safety and handling, toxicity/biomedical effects, pharmacology, exposure standards and regulations, monitoring and analysis information for related NLM databases that link to HSDB, such as NLM ChemIDplus and Haz-Map. The information sources used shall be indicated in detail, e.g., include the page in a journal publication and/or link to the section of an online database. Such sources must be resources judged acceptable by the NLM project team. Identification of additional resources (online or otherwise) and more efficient ways to provide this information is needed, especially if it can increase the number of new or updated records a year from the current 350-to-400 a year to 600 a year or more.

6. Provide data and information for special projects related to Parts 1-5 of Task 1.

Similar activities may be performed outside the usual record building schedule.

This task is in support of special enhancements to HSDB to improve how current the information is and/or expand content or impact on existing or new user groups. Interactions with the contractor leading Sections 2, 3, and 7 of HSDB records will be needed to coordinate the completion of the special projects.

Note: For these tasks, the information collected will be entered into the NLM CMS.

Occasionally, this might require submission via email in Microsoft Word or Adobe PDF files for review/discussion by the NLM project officer and/or NLM project team. There are no structured or hierarchical lists. The data for some of the special projects may be images, e.g.: gif, png, jpg, or bmp files.

TASK 2 - Quality Control Review of HSDB Records

1. The contractor shall be responsible for assembling a group of scientists with professional backgrounds in the various technical disciplines represented in HSDB, to serve as Quality Control (QC) staff. This QC group shall respond to questions by the data extraction staff and review all input by the data extraction contractors for populating Sections 1 (Substance identification), 4 (Safety and handling), 5 (Toxicity/Biomedical effects), 6 (Pharmacology), 8 (Exposure standards and regulations), 9 (Monitoring and analysis methods), and 10 (Additional references) of each HSDB record being developed or updated. The HSDB Data Extractor’s Manual describes the different data elements (fields) and provides examples of how data are presented in HSDB. This manual can be requested from NLM.

2. The contractor’s QC group shall respond to questions and review all input before the information is reviewed by the SRP and transferred into the public version of HSDB. The contractor’s QC staff shall include experienced scientists with appropriate qualifications in toxicology, safety and handling, exposure standards and regulations, etc. The content review shall be for the scientific https://chem.nlm.nih.gov/chemidplus/ https://hazmap.nlm.nih.gov/

5 | P a g e reasonableness, completeness, and validity of the data, unnecessary duplication of information, and data placement in the record, adherence to HSDB rules and procedures, and gaps and deficiency in coverage. If necessary, HSDB records shall be cycled back to the contractor’s staff for corrective action.

3. Questions that cannot be resolved by the QC group, the data extraction staff, and

NLM project staff shall be directed to the SRP for clarification and resolution. The

CMS provides commenting capability that allows the reviewer to indicate how the information needs to be modified, enhanced or deleted. E-mails and phone interactions between the SRP reviewer and contractor are encouraged when more details are needed to take corrective action relating to a data statement.

TASK 3 - Support for the Scientific Review Panel (SRP) and peer review meeting activities and materials

The HSDB SRP was established by NLM and includes experts in toxicology, chemistry, environmental fate and engineering, occupation health, industrial hygiene, hazardous waste handling, pharmacology, clinical toxicology and other related disciplines. The purpose of the SRP is to conduct an in-depth peer review of all data fields within assigned HSDB records. This includes those data fields provided by the other NLM contractor. The primary contractor shall appoint a person to serve as the Executive Secretary to the SRP; this individual shall have equivalent professional and scientific qualifications acceptable as a colleague by the SRP membership. The Executive Secretary functions as a liaison between the SRP and NLM. This individual shall brief NLM personnel on the outcome of the particular SRP meeting. Other duties shall include assisting the scribes during the actual meeting, producing notes concerning advice by and/or concerns of the SRP membership. The Executive Secretary shall maintain a roster of scientists qualified to serve as SRP members and who have expressed a willingness and ability to do so. NLM reserves the right to select SRP members and the Executive Secretary, and in the future may assign term limits for all or some SRP members.

The Executive Secretary shall attend all SRP meetings, with the locations currently being in the Washington DC region (Bethesda & Rockville, Maryland).

Members of the primary contractor’s staff, and at least one secondary contractor’s staff, need to be on site at the SRP meetings. Assisted by members of the contractor’s QC group and/or the contractor’s data extraction staff, they will take accurate and detailed notes of the SRP deliberations and the comments about the HSDB records under review. After each SRP meeting, the records shall be revised by the primary and secondary contractor’s staff in accordance with SRP and NLM approaches and instructions. Where information in the record is found erroneous or suspect, the SRP can instruct it to be deleted from a HSDB record. If sufficient information is available for SRP acceptance, that data

6 | P a g e statement receives a “PEER REVIEWED” data tag from NLM HSDB staff. Other tags used to indicate data quality include “QC REVIEWED” for information examined by the contractor’s Quality Control group; “UNREVIEWED” for data that has not been evaluated. The data tags are added to the occurrences by

NLM staff during the process of moving HSDB records from the HSDB maintenance system to the HSDB public database.

The primary contractor shall provide logistical support to the SRP meetings, based on the following criteria:

• To be determined by the Government each year, a set number of face-to-face meetings will be held. Currently, this is two meetings of three working days a year. Selected members of the primary contractors, and one or more members of the secondary contractor’s staff will attend all face-to-face meetings. NLM reserves the right to adjust the frequency and duration of SRP meetings.

• Make all meeting arrangements, including the preparation and advance mailing of HSDB information for each SRP meeting. Send notices of meeting dates, times, and locations, and maintain the roster of SRP members with their contact information (affiliations, addresses, email, telephone numbers, etc.). Coordinate the printing and mailing (or emailing) of the records to be used for each SRP meeting with NLM staff.

• Make all facilities arrangements, including reservations and arrangements for lodgings and meeting rooms, provision of computers/printer supplies, internet access, audio visual, etc. Set-up the SRP meeting space with materials and track all costs for each meeting. NLM reserves the right to request meeting costs for review and comparison.

• Reimburse honoraria, travel and per diem expenses to SRP members.

NLM reserves the right to request a summary of these costs for review and comparison.

TASK 4 - Comment Incorporation

After each SRP meeting, the primary contractor shall incorporate all comments, changes, additions and deletions recommended by the SRP members into the appropriate HSDB records. This necessitates knowing the data fields and the appropriate input instructions in the CMS; instructions are indicated in the NLM HSDB Data Extractor’s Manual that will be provided to the primary and secondary contractor’s staff.

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Comment incorporation will begin at the end of each SRP meeting for those records specifically identified by the SRP members. Many of the questions and comments will be addressed by the contractor’s comment incorporation staff under the direction of a senior-level coordinator. All comments and changes shall be proofed by a contractor’s scientific editor before the records are released to NLM for public system update. The contractor’s editor(s) shall examine the entire record looking for aberrations and insuring that the modified information is what the SRP intended. NLM and/or the contractor may request a post-SRP meeting debrief to discuss SRP comments for incorporation or any other concerns prior to finalizing the records.

It is the intent of both NLM and the contractor to achieve only one meeting backlog of prior SRP reviewed records. It is extremely important that the new information make its way to the public database as soon as possible so that current availability to the user community is maintained. NLM reserves the right to perform express creating and/or updating of records with only a QC review when necessary to expedite public release of records.

TASK 5 - Develop and Maintain a Current and Comprehensive Collection of Data Sources for HSDB, and include Access to Relevant online sources

The primary contractor shall assemble and maintain a complete collection of HSDB core sources as identified by NLM. This working collection shall be used by the data extractors for record building and to keep aware of the current literature and online resources (databases and websites) in subject areas covered by the HSDB. The contractor shall also recommend new literature and/or sources for HSDB for NLM consideration and approval. The SRP may also make source recommendations.

It is important that the collection of HSDB core data sources is easily accessible to the contractor’s data extraction staff and QC reviewers; it is equally important that the collection be secure. The contractor shall be responsible for ensuring that easy access and security are maintained. Non-project personnel shall not be allowed unsupervised access to the HSDB source collection and shall not be allowed to remove information materials without the permission of the contractor’s project manager. As technology evolves, some sources may be accessed electronically in place of printed texts. (Refer also to Section 508 Compliance section)

TASK 6 - Annual or Periodic Source Updates

New editions of core data sources are issued annually or periodically and will be used to update all HSDB records containing data values from the newest edition, a procedure known as a ‘source update.’ One such source is the ‘Threshold Limit

Values (TLVs) for Chemical Substances and Physical Agents, and Biological

Exposure Indices (BEIs)’ issued by the American Conference of Governmental

Industrial Hygienists (ACGIH). Other special source enhancement will be performed as Special Projects under Task Area 7.

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TASK 7 - Special Projects

NLM, in a continuing effort to search for more thorough, more efficient and more cost-effective ways of building the HSDB, may propose certain special projects during the course of the period of performance. These special projects are likely to include, but not limited to the following:

• Special Source Enhancements – Such source updates will be decided by NLM;

the contractor will be instructed to update a particular field across the entire set of HSDB substances

• New Sources for Source Update – Before adopting a new source for source updating, the contractor may be requested to analyze a new source and develop a work plan to add that data

• Develop new procedure/s for quick and accurate updates to reflect current news, warnings, etc. Current updating procedures must be modified to make them cost effective. The contractor will be asked to review their procedures and suggest alternative methods. (Refer also to Section 508 Compliance section)

Transition Requirement

In order to minimize the disruption of service for any follow-on contract, the incumbent, if not selected, will participate with the new Contractor and the Contracting Officer Technical Representative (COTR) in an orderly transfer of services for any follow-on contract. It is anticipated that a 30-day transition period is set aside at the end of the routine performance period for the phase-out of the Contractor’s performance. Any resulting contract from the Statement of Work (SOW) will include the phase-out transition period in the established completion date. All electronic and print documentation and materials developed under the contract shall be transferred, as directed by the COTR, to the successor for the NLM contract.

Period of Performance

The NLM anticipates making an award in June or July 2019. This task order will include a 12-month base year with two 12-month option periods.

Place of Performance

Work is to be accomplished at the contractor’s site, except for the SRP meetings that take place at locations determined by NLM, e.g., a hotel in Bethesda or Rockville, Maryland.

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Equipment and Facility

The contractor shall provide equipment, software, and supplies except for the CMS that will be provided and maintained by NLM along with user support.

Deliverables

1. Information for Sections 1 (Substance identification), 4 (Safety and handling), 5 (Toxicity/Biomedical effects), 6 (Pharmacology), 8 (Exposure standards and regulations), 9 (Monitoring and analysis methods), and 10 (Additional references) for the substances assigned by NLM via the CMS. After each SRP meeting, corrected records in the CMS based on SRP comments in final format after peer review.

2. Any additional related data as described in Tasks 1-7 in electronic format.

3. Information for Sections 1 (Substance identification), 4 (Safety and handling), 5 (Toxicity/Biomedical effects), 6 (Pharmacology), 8 (Exposure standards and regulations), 9 (Monitoring and analysis methods), and 10 (Additional references) for the substances as requested in a specified electronic format.

4. Monthly status reports electronically to the NLM COR(s) and include the following:

a) Number of HSDB records completed

b) Summary of costs and labor hours associated with tasks

c) Description of special information provided, i.e. physical/chemical data

d) Number of submission abstracts

e) General description of any activities performed

Billing

The contractor will bill monthly and send an electronic invoice via email to the COR and

CO and a hardcopy to NIH Commercial Accounts.

Level of Effort

1. LABOR CATEGORIES/GOVERNMENT ESTIMATE

NLM estimates that the equivalent of about three Full-Time Equivalent employees (FTEs) will be required each year. The offeror shall suggest a labor mix based on the technical approach described in the proposal. The labor mix may include scientists with varying levels of expertise.

The following is a sample of positions, labor hours, and experience levels that

10 | P a g e would be appropriate for performance of this requirement. The vendor may propose other labor categories and experience levels, if they would contribute to a better, more efficient solution. However, the vendor must demonstrate that the personnel and proposed experience level meet the Government’s requirement.

Labor Category

Base Year (Estimated Hours)

Option Year 1 (Estimated Hours)

Option Year 2 (Estimated Hours)

Project Manager

200 200 200

Senior Information Specialist

3000 3000 3000

Mid-level Scientist

3000 3000 3000

Senior Scientist

2000 2000 2000

Conference Manager

75 75 75

Senior Contract Administrator

75 75 75

Total Estimated Hours:

8350 8350 8350

a. Project Manager – Minimum education: master’s degree with significant project management experience with large-scale scientific database multi-year projects.

b. Senior Information Specialist – Minimum education: bachelor’s degree with significant experience directly related to the project tasks. Master’s degree preferred with significant experience directly related to the project tasks.

Skills related to the project tasks include: experience identifying, reviewing, and interpreting scientific literature based on content; knowledge of, and experience with, authoritative safety and handling, toxicity/biomedical effects, pharmacology, exposure standards and regulations, and monitoring and analysis methods of online resources (databases and web sites) and publications; and experience categorizing scientific information for large-scale databases.

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c. Mid-level Scientist – Minimum education: bachelor’s degree with significant experience directly related to the project tasks. Master’s degree preferred with significant experience related to project tasks. Skills related to project tasks include: experience reviewing, interpreting, calculating, and managing scientific information from online resources (databases and web sites) and literature for large-scale databases; experience writing summaries of safety and handling, toxicity/biomedical effects, pharmacology, exposure standards and regulations, and monitoring and analysis methods;

experience researching toxicology data within authoritative sources;

experience reviewing and interpreting information related to the above areas, and experience consulting with PhD-level scientists in toxicology and other topics related to the HSDB records, e.g., safety and handling, and exposure standards and regulations.

d. Senior Scientist – Minimum education: master’s degree with significant experience directly related to the project tasks. PhD preferred with significant experience directly related to the project tasks. Skills related to project tasks include: experience reviewing, interpreting, calculating, and managing scientific information from online resources (databases and web sites) and literature for large-scale databases; experience writing summaries of safety and handling, toxicity/biomedical effects, pharmacology, exposure standards and regulations, and monitoring and analysis methods; experience researching toxicology data within authoritative sources; experience reviewing and interpreting information related to the above areas, and experience consulting with PhD-mid-level scientists in toxicology and other fields related to the HSDB records, e.g., safety and handling, and exposure standards and regulations.

e. Conference Manager - Minimum education: bachelor’s degree with significant project management experience with organizing and managing rather large (30 person or more) multi-day conferences.

f. Senior Contract Administrator - Minimum education: bachelor’s degree with significant contracting experience with large-scale and rather complex projects.

Section 508 Compliance:

Section 508 Evaluation Factors

Responses to this solicitation will be evaluated based in part on the responsiveness to the identified Section 508 requirements and consideration for accessibility. If requested deliverables are commercially available that meet some but not all of the applicable Section 508 standards, proposal evaluation will favor the response that best meets the identified standards, in the greater context of selecting the proposal that represents the overall best value. Responses to the “Hazardous Substances Data Bank (HSDB) Manufacturing and Use, Chemical and Physical Properties, and Environmental Fate and Exposure Potential Information” solicitation must include vendor responses to applicable

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Section 508 elements identified in the Government Product Accessibility Template (GPAT) attached as Attachment 02. See instructions on how to complete the GPAT below.

Section 508 Acceptance Criteria

The “Hazardous Substances Data Bank (HSDB) Manufacturing and Use, Chemical and Physical Properties, and Environmental Fate and Exposure Potential Information” delivered as a result of this solicitation will be accepted based in part on satisfaction of identified Section 508 requirements for accessibility.

Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY

ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report

Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/contracting/technology/vendors.html.

How to Complete a GPAT

The attached Section 508 Government Product/Service Assessment Template (GPAT) consists of a series of tables. Section 508 provisions are separately listed by row in tables grouped by their category (i.e., Section 1194.xx). To complete the GPAT, you are asked to complete entries in two columns (labeled How does the EIT meet this

Requirement? and Please Explain) for every provision considered applicable. Where

Section 508 has been found to be applicable to this requirement, “yes” and/or “maybe” entries will be listed under the Applicable column in the GPAT tables. You are not obligated to respond where the Applicability finding is either blank or a “no” value for that Section 508 provision. Please answer honestly and be prepared to work with HHS to improve accessibility for your product/service if it is acquired.

For each applicable provision, you are asked to identify the level of support your product/service provides for this provision in the “How does the EIT meet this requirement?” column. In relation to this response, elaborate in the “Please Explain” column. A response of “Fully” is understood to mean the product/service fully meets the letter and intent of the Section 508 provision described in that table row. Along with this response, you are asked to list exactly what features of the product/service do meet and describe how they are used to support the provision. A response of “Partially” is understood to mean that the product/service does not entirely meet the letter and intent of the provision but does provide some level of accessibility. In conjunction, you are asked to explain exactly what features of the product do meet and describe how they are used to support the criteria, as well as explain exactly what parts of the product do not meet and describe how they fail to support the provision’s criteria. You may also list what other methods exist in the product/service and describe how they are used to http://www.hhs.gov/web/508/contracting/technology/vendors.html

13 | P a g e support the criteria. A “no” response is understood to mean that the product/service does not meet the letter and intent of the provision. In the ‘please explain’ field, elaborate on how the product does not support the provision’s criteria.

Further References www.Section508.gov http://www.access-board.gov/508.htm http://www.hhs.gov/web/policies/standards/index.html http://www.section508.gov/ http://www.access-board.gov/508.htm http://www.hhs.gov/web/policies/standards/index.html

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