SoW_Drug Database Licensing - Final.docx

Statement of Work (SOW) for the Drug Database Licensing

1.0 General

1.1 Background

The National Institutes of Health (NIH) is an agency within the U.S. Department of Health and Human Services (DHHS) that consists of 27 separate Institutes and Centers (ICs) and is principally located in the Washington-Baltimore Metropolitan Area. NIH’s mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability.

The National Library of Medicine (NLM), a part of the NIH, has a mission to “assist with the advancement of medical and related sciences and to aid in the dissemination and exchange of scientific and other information important to the progress of medicine and to the public health.” NLM collects, organizes, preserves, and disseminates the world’s biomedical information for the good of the public. NLM provides resources to many different audiences, including several web-based resources that provide health information intended for a consumer audience. This audience includes patients, their families and friends, and anyone from the general public seeking information about diseases, health conditions, and wellness topics.

To assist consumers in obtaining the information needed to make informed decisions about health care, the National Library of Medicine (NLM) has developed MedlinePlus (medlineplus.gov), an easily understandable Web resource for the public. MedlinePlus contains and links to information from authoritative health Web sites and content providers, especially those from the National Institutes of Health. NLM makes MedlinePlus available to the public through a variety of MedlinePlus-branded Web sites, Web services, Web applications, APIs, email and social media communications, XML files and search results.

1.2 Objective

NLM intends to license consumer-level drug information in English and Spanish to assist the public in locating information about prescription and over-the-counter medications via MedlinePlus. “MedlinePlus” means all MedlinePlus-branded Web sites, Web services, Web applications, APIs, email and social media communication, XML files and search results.

1.3 Scope of Work

The consumer-level drug information is an evidence-based medicine resource on prescription and over-the-counter medicines for MedlinePlus. NLM requires unique, authoritative information about individual drugs in both English and Spanish for inclusion in the MedlinePlus website. These resources will be provided as monographs, formatted as XML, and delivered via SFTP (Secure File Transfer Protocol). Regular monthly content updates and a mechanism to address feedback are also required.

1.4 Place of Performance

Contracts may be performed entirely at the contractor’s office or remotely.

1.5 Period of Performance

The period of performance of this contract consists of a base year and four option years.

Base year (7/1/2022 – 6/30/2023) Option 1 (7/1/2023 – 6/30/2024) Option 2 (7/1/2024 – 6/30/2025) Option 3 (7/1/2025 – 6/30/2026) Option 4 (7/1/2026 – 6/30/2027)

2.0 Delivery or Deliverables

2.1 The vendor shall provide a minimum of 1,200 English monographs in English and Spanish created and reviewed by professionals, as detailed in Section 3.2 below. The vendor shall deliver updated monograph and mapping file content to NLM at least once a month. The response shall describe the vendor’s regular update schedule and a description of content of the update and the delivery mechanism. Raw XML delivered via SFTP (Secure File Transfer Protocol) is the desired format.

2.2 The vendor will be required to provide NLM with technical support and advanced delivery of the content files within 2 weeks of contract award by NLM so that NLM can plan for the implementation of the content pages and link to these pages on MedlinePlus-branded sites, services and files.

3.0 Specific Requirements/Tasks (mandatory)

The vendor shall provide the following:

3.1 The Offeror shall provide files that are customizable in order to be integrated into the MedlinePlus environment.

3.2 Minimum of 1,200 English monographs created and reviewed by professionals with appropriate expertise, such as clinicians and pharmacists.

3.2.1 The intended audience for the monographs shall be consumers in the United States. The vendor shall describe how they address the needs of a U.S. consumer audience in their writing and editorial policies.

3.2.2 Features and product offerings will be evaluated as they exist at the time of proposal submission. Beta releases and planned updates will not be considered.

3.2.3 Monographs shall be written in plain language and at no higher than 8th grade reading level. The vendor shall include the measurement scale used to determine the reading or grade level.

3.2.4 All content shall be free of commercial endorsements and advertisements.

3.2.5 Equivalent number of monographs in Spanish.

3.2.5.1 Spanish monographs shall be in culturally neutral Spanish appropriate for a U.S. consumer audience. Translations shall be done by trained professionals, and not automated translation.

3.2.5.2 The translations shall be culturally sensitive and appropriate for a wide Spanish-speaking audience. The vendor shall describe their translation procedures, including quality control policies.

3.2.5.3 The vendor shall describe how they associate equivalent English and Spanish monographs. This association can be a unique ID for each drug and clear mapping to the Spanish drug.

3.2.5.4 The ability to toggle between all English and Spanish monograph at the individual level.

3.3 Coverage of both prescription and over-the-counter medications.

3.3.1 Coverage of both single ingredient medications and combination ingredient medications.

3.3.2 Each monograph shall include the ingredient (generic) name for the medication that is used in the United States, alternate or synonymous medication names, when applicable, and associated brand names and brand names of combination products used in the United States.

3.4 Delivery of monographs in well-formed, valid XML format with accompanying DTD via SFTP (Secure File Transfer Protocol) is the desired format.

3.3.1 Delivery of individual XML file files for each monograph in each language – One XML fie for the English monograph and a separate XML file for the equivalent Spanish monograph.

3.5 A stand-alone file that maps all the relevant RxNorm Concept Unique Identifiers (RXCUIs), including, at a minimum, all the Semantic Clinical Dose (SCDF) RXCUIs, to each monograph. The file shall include at a minimum, the monograph ID, the English monograph name, the SCDF RXCUI and the SCDF RXCUI name. If the English and Spanish monograph IDs are not identical for equivalent English/Spanish monographs, then the file shall also include both English monograph ID and the Spanish monograph ID and shall indicate the equivalent relationship between the two.

3.5.1 The file shall be delivered at the same time as the monograph updates, and the file shall reflect the most recent monograph content. RXCUI mappings embedded within each individual monograph XML file are also acceptable. Embedded mappings shall also include, at a minimum, all relevant Semantic Clinical Dose Form (SDDF) RXCUIs for the given monograph.

3.5.2 NLM expects that RXCUI mappings will be identical for the equivalent English and Spanish monographs. If there is ever a circumstance where the mapping would differ between the equivalent English and Spanish monographs, the vendor shall describe the circumstance and how they handle it from an editorial perspective and within the stand-alone mapping file or embedded mappings.

3.5.3 The vendor shall explain their process of mapping monographs to RXCUIs and their process for updating and maintaining those mappings.

3.6 The vendor shall provide the following information, or substantially similar content, in each monograph. Contents may include, but not limited to: Information on why a medication is prescribed, how it is used, precautions, side effects, interactions, storage, missed doses and overdose information. The vendor shall list the topics or sections that they cover on each monograph and describe the contents of those topics/sections.

3.7 The vendor shall explain their process for keeping the monographs up to date.

3.8 The vendor shall be up to date and make editorial decisions about FDA warnings at the monograph level for both English and Spanish monographs. Examples of warnings include but are not limited to safety alerts, ongoing safety reviews, safety communications and notices of withdrawal from the market.

3.8.1 The vendor shall address whether they provide information about FDA approval status at the monograph level.

3.9 When NLM identifies major content issues, NLM will communicate the issue with the vendor. The vendor shall describe their procedure and turn-around time for content updates, including procedures and timelines for emergency content updates.

3.10 NLM will forward to the vendor any feedback received from users regarding content. The vendor shall describe their procedure for reviewing this feedback, incorporating this feedback into their editorial cycle, and following-up with NLM on any action taken.

3.11 Allow NLM to host all the vendor-provided content on NLM servers, including pill images, if applicable.

3.12 Allow for MedlinePlus co-branding on drug information pages.

4.0 Section 508 Requirements (mandatory)

4.1 Section 508 of the Rehabilitation Act requires that Federal agencies' electronic and information technology is accessible to people with disabilities. The drugs database monographs, and any other content offered shall be Section 508 compliant.

4.2 The vendor shall review and attest that they can or cannot comply (providing detailed explanations) with the requirements in the ICT Accessibility Requirements Statement per the Revised Section 508 of the Rehabilitation Act (Attachment 1) in their proposal.

5.0 Additional Requirements

5.1 Include the cost of licensing this product. The cost must be an annual flat fee for providing the content to users of any MedlinePlus branded Web site, the ability of end-users of MedlinePlus-branded sites to print, email and share links for individual, personnel use and for providing links to the content on any MedlinePlus-branded Web service, Web application, API, email and social media communication, XML and search result.

5.2 Include a sample license agreement governing the use of the content on all MedlinePlus-branded Web service, Web application, API, email and social media communication, XML and search result. The license agreement must also address NLM’s rights related to the sharing of links to the content on MedlinePlus-branded sites, services, applications, communications, files and search results.

5.3 Include your copyright statement and any required disclaimers in both English and Spanish.

If the vendor requires their logo to be displayed on all vendor-supplied content pages, the logo must be smaller than 70x70 pixels and NLM must be allowed to determine the placement of the logo on the content pages. Include a sample logo (in English and Spanish if the logo differs in each language) and any display requirements.

6.0 Preferred Content Features (not mandatory)

6.1 Within the stand-alone file that maps all the relevant RXCUIs or within the RXCUIs embedded in the individual monograph XML files, additional RXCUI mappings of the following term types may be included for each monograph. Note: SCDF mappings are required. See “Mandatory Content Requirements” above.

BPCK – Brand Name Pack BN – Brand Name SCDC – Semantic Clinical Drug Component SCD – Semantic Clinical Drug SBD – Semantic Branded Drug SBDC– Semantic Branded Drug Component GPCK – Generic Pack SBDF – Semantic Branded Drug Form

6.2 If the vendor provides the RXCUI mappings in a stand-alone file, the stand-alone file includes the Spanish monograph name for each entry.

6.3 A pronunciation guide for the monograph name (ingredient/generic name).

6.4 Flexibility in formatting, excerpting, and visual presentation of text and graphical data.

6.5 Mapping of applicable monographs to other terminologies such as the NDC (National Drug Code).

6.6 Additional structural elements of your firm’s data (e.g., schema) to make the content of monographs easier to manipulate and display.

6.7 Pill images with meaningful alt text in both English and Spanish. The vendor must provide an identifier for linking pill images to the appropriate English & Spanish monographs. If the vendor offers pill images, they must include 5 sample images with their proposal. The vendor must also describe or demonstrate how they associate individual pill image files to individual English and Spanish monograph XML files. The pill images must be delivered at the same time as the monograph content. Image dimensions must be specified as well.

6.8 Citations or references, with PubMed links, in each monograph.

6.9 Relative links to other monographs in the collection.

7.0 Meetings

Meetings will be conducted through teleconferencing as approved by the Contracting Officer.

7.1 Post-award Kickoff Meeting

Within 5 business days of contract award, the Government will conduct a post-award kickoff meeting at a specific date and time to be mutually agreed upon.

7.2 Quarterly Project Status Reviews

Quarterly status meetings to be conducted on the first week of each quarter at a mutually agreeable schedule. The vendor is responsible for reporting the previous quarter’s activities (including any risks, issues, or concerns, and actual or recommended actions for their mitigation), and projected activities for the following quarter.

8.0 Required Travel and Other Direct Costs (ODCs)

No travel is required by the vendor.

9.0 Government Furnished Property/Equipment/Information

No government-furnished property/ equipment/ information to be furnished to the vendor.