Contract Language

Attachment 7

The following special requirements language shall be included in CDC solicitations and resultant contracts that involve the collection or generation of public health data. This language is pursuant to the mandated HHS Public Access Policy https://www.hhs.gov/open/public-access-guiding-principles/index.html which requires CDC to include information in its solicitations/contracts to ensure offerors/contractors are informed of the requirement for a Data Management Plan and the requirement to make public health data accessible.

H.XX PUBLIC ACCESS TO CDC FUNDED DIGITAL PUBLIC HEALTH DATA (Nov 2018)

Public Health Data

Definition: Public Health data means digitally recorded factual material commonly accepted in the scientific community as a basis for public health findings, conclusions, and implementation

When CDC is funding, in whole or in part, via a contract as defined in FAR 2.101, with respect to public health data, a CDC-approved Data Management Plan (DMP) – a plan for digital data management, sharing, and preservation is required prior to commencing any related services or work. For contracts where public health data collection or generation activities may become necessary during the period of performance (e.g. via contract modification), a DMP will be required to be submitted and evaluated during the period of performance. The DMP is a deliverable and a living document that should be updated throughout the life cycle of data. A final DMP is required at the end of the contract performance that shows where the data are deposited and how they are being made accessible or justification provided for not doing so.

Data Management Plan

A DMP for each collection and/or generation of public health data should include the following information:

• A description of the public health data to be collected or generated in the contract period of performance;

• Standards to be used for the collected or generated public health data;

• Mechanisms for or limitations to providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights) or justification for why data cannot be made accessible. This section should address access to identifiable and de-identified data (see below for additional information about access);

• Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and

• Plans for archiving and long-term preservation of the data, or explanation of why long-term preservation and access are not justified. This section should address archiving and preservation of identifiable and de-identified data (see below for additional information regarding archiving).

Examples of Data Management Plan Templates and Tools:

University of California: https://www.cdlib.org/services/uc3/dmpt.html

USGS: http://www.usgs.gov/datamanagement/plan/dmplans.php

Access to and Archiving of the Data

To the extent that is feasible, contractors should make public health data accessible. Rights in Data clauses (FAR 52.227-14 Rights in Data – General, 52.227-16, Additional Data Requirements, FAR 52.227-17 Rights in Data – Special Works, or FAR 52.227-18 Rights in Data-Existing Works), may be applicable and incorporated into contracts, depending on the Statement of Work involved. The data rights clauses give the government “unlimited rights” in data first produced (when funded by government solely) in the performance of a contract. “Unlimited rights” is an unlimited license to use, disclose or reproduce the data; it does not give the government ownership of the data. Unlimited rights in data would allow the government to archive and make public non-proprietary data first produced in contract performance.

Contracts that do not include terms for submittal of public health data to CDC, are expected to plan and prepare for providing access to, and archiving/long-term preservation of, collected and/or generated data within the contract period of performance, as set forth below. The final version of a collected and/or generated data set intended for release or sharing should be made available within thirty (30) months after the end of the data collection or generation, except surveillance data, which should be made accessible within a year of the end of a collection cycle. For public use de-identified (removal of sensitive identifiable or potentially identifiable information) datasets, an accompanying data dictionary, and other documentation relevant to use of the data set should be deposited in a sustainable repository to provide access to the data. Data that cannot be de-identified can be provided as restricted data upon request under a data-use agreement or onsite controlled use.

For data underlying a scientific publication, the contractor shall make the data available coincident with publication of the paper, at a minimum a machine-readable version of the data tables shown in the paper, unless the data set is already available via a release or sharing mechanism. In addition, contractors should ensure the quality of data they make accessible and seek to provide the data in a machine readable and nonproprietary format. Contractors who fail to release public health data in a timely fashion may be subject to procedures normally used to address failure to comply with the terms and conditions of the contract and may be grounds for the Contracting Officer to terminate the contract for default. Irrespective of whether the data are made accessible or not, Public health data of value should be preserved long-term.

A final DMP is required at the end of the contract performance. The final DMP will indicate the location of the deposited data and the manner of access granted to the data. There needs to be an adequate justification for not making data accessible and this justification must be documented in the DMP and approved by the Contracting Officer’s Representative.

Additional information is available at https://www.hhs.gov/open/publicaccess/index.html.

CDC Language for Solicitations or Requests for Task Order Proposals in implementation of the CDC Policy on Public Health Research and Non-research Data Management and Access

Section L.XX, Data Management Plan (Language For use under Uniform Contract Format Section L, or task order Instructions to Offerors)

CDC requires awardees of contracts that involve the collection or generation of public health data with federal funds to develop, submit, and comply with the requirement of a Data Management Plan (DMP) for each collection or generation of public health data undertaken. Consistent with the terms of and activities expected under the statement of work, the offeror shall develop and submit a DMP as part of its proposal in response to this solicitation, and if awarded a contract, update the DMP throughout the life cycle of the public health data collected or generated during the performance period. The DMP shall describe, to the extent appropriate, the data to be collected or generated; plans for making the data accessible that state what the data represent and potential limitations for use, provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights (where these protections preclude making data accessible, justification must be provided); and plans for archiving and long-term preservation of the data. Costs, if any, associated with developing and implementing a DMP, including costs of sharing, archiving and long-term preservation, are allowable costs and shall therefore be reflected in an offeror’s Business Proposal. A DMP must be developed in accordance with the below guidelines. A proposal received without a DMP will be deemed “Unacceptable”.

A DMP for each collection and/or generation of public health data should include the following information:

• A description of the public health data to be collected or generated in the contract period of performance;

• Standards to be used for the collected or generated public health data;

• Mechanisms for or limitations to providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights) or justification for why data cannot be made accessible This section should address access to identifiable and de-identified data (see below for additional information about access);

• Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and;

• Plans for archiving and long-term preservation of the data, or explanation of why long-term preservation and access are not justified. This section should address archiving and preservation of identifiable and de-identified data (see Public Access to CDC Funded Digital Public Health Data) for additional information regarding archiving).

Examples of Data Management Plan Templates and Tools:

University of California: https://dmp.dlib.org/

USGS: http://www.usgs.gov/datamanagement/plan/dmplans.php

Section M.XX, Evaluation of the Data Management Plan (DMP) (Language For use under Uniform Contract Format Section M, or task order Evaluation Criteria)

The Data Management Plan submitted as a part of the offeror’s proposal will be evaluated during the pre-award process for quality and completeness and will potentially require later revision as the DMP will be updated during the contract period of performance. The DMP will be rated on a “Pass/Fail” basis considering the clearness, appropriateness, and inclusiveness of the elements described under Section L. The Government’s evaluation will consider the level or magnitude of the standards to be used for the collected or generated public health data as well as the types of mechanisms for or limitations in providing access to and sharing of the data. Evaluation will also consider how well the DMP clearly outlines plans for archiving and long-term preservation of the data. For statements of work that involve defined projects which include public health data collection or generation of data, proposals submitted without the required DMP will be deemed unacceptable. For contracts where data collection or generation of data activities may later become known and necessary (e.g. via contract modification), DMPs will be required to be submitted for evaluation and acceptance during the period of performance and must be developed in accordance with Public Access to CDC Digital Public Health Data.