[Federal Register Volume 85, Number 12 (Friday, January 17, 2020)]
[Notices]
[Pages 3085-3087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00689]


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OFFICE OF SCIENCE AND TECHNOLOGY POLICY


Request for Public Comment on Draft Desirable Characteristics of 
Repositories for Managing and Sharing Data Resulting From Federally 
Funded Research

AGENCY: Office of Science and Technology Policy (OSTP).

ACTION: Request for Comments.

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SUMMARY: The White House Office of Science and Technology Policy is 
seeking public comments on a draft set of desirable characteristics of 
data repositories used to locate, manage, share, and use data resulting 
from Federally funded research. The purpose of this effort is to 
identify and help Federal agencies provide more consistent information 
on desirable characteristics of data repositories for data subject to 
agency Public Access Plans and data management and sharing policies, 
whether those repositories are operated by government or non-
governmental entities. Optimization and improved consistency in agency-
provided information for data repositories is expected to reduce the 
burden for researchers. Feedback obtained through this Request for 
Comments (RFC) will help to inform coordinated agency action.

DATES: To ensure that your comments will be considered, please submit 
your response on or before 11:59 p.m. ET on March 6, 2020.

ADDRESSES: Comments should be submitted online to: 
[email protected]. Email submissions should be machine-readable 
[pdf, word] and not copy-protected. Submissions should include ``RFC 
Response: Desirable Repository Characteristics'' in the subject line of 
the message.
    Instructions: Response to this RFC is voluntary. Each individual or 
institution is requested to submit only one response. Submission should 
not exceed 5 pages in 12 point or larger font, and should be paginated. 
Responses should include the name and organizational affiliation(s) of 
the person(s) filing the comment. Additionally, to assist in analyzing 
responses, respondents are requested to indicate the primary scientific 
discipline(s) in which they work (e.g., life sciences, physical 
sciences, social sciences) and their role (e.g., researcher, librarian, 
data manager, administrator). Comments containing references, studies, 
research, and other empirical data that are not widely published should 
include copies or electronic links of the referenced materials. 
Comments containing profanity, vulgarity, threats, or other 
inappropriate language or content will not be considered.
    Comments submitted in response to this notice are subject to FOIA. 
Responses to this RFC may also be posted, without change, on a Federal 
website. Therefore, we request that no business proprietary 
information, copyrighted information, or personally identifiable 
information (beyond filing name and institution) be submitted in 
response to this RFC.
    In accordance with FAR 15.202(3), responses to this notice are not 
offers and cannot be accepted by the Government to form a binding 
contract. Additionally, those submitting responses are solely 
responsible for all expenses associated with response preparation.

FOR FURTHER INFORMATION CONTACT: Lisa Nichols at 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The Subcommittee on Open Science (SOS) of the National Science and 
Technology Council's Committee on Science (https://www.whitehouse.gov/ostp/nstc/) convenes more than twenty Federal departments and agencies 
(hereafter ``agencies'') that support research and development (R&D). 
It aims to advance open science and foster implementation of agency 
Public Access Plans that were developed in response to the 2013 White 
House Office of Science and Technology Policy (OSTP) memorandum 
entitled ``Increasing Access to the Results of Federally Funded 
Scientific Research'' that called for improved access to data and 
publications resulting from Federally funded R&D. [For more information 
on agency Public Access Plans, see https://www.cendi.gov/projects/Public_Access_Plans_US_Fed_Agencies.html. For more explanation 
regarding Federally funded research data, see 2 CFR 200.315(e)(3).] One 
goal of the Subcommittee's efforts is to improve the consistency of 
guidelines and best practices that agencies provide about the long-term 
preservation of data from Federally funded research, including suitable 
repositories for preserving and providing access to such data, 
considering agency missions, best practices, and relevant standards. 
According to OMB Circular A-81, section 200.315, ``Research data means 
the recorded factual material commonly accepted in the scientific 
community as necessary to validate research findings, but not any of 
the following: preliminary analyses, drafts of scientific papers, plans 
for future research, peer reviews, or communications with colleagues.'' 
[See: https://www.federalregister.gov/documents/2013/12/26/2013-30465/uniform-administrative-requirements-cost-principles-and-audit-requirements-for-federal-awards#sec-200-315.] These efforts are 
consistent with and supportive of other Administration priorities, such 
as the Federal Data Strategy and its associated set of Practices to 
leverage data as a strategic asset [For more information on Federal 
Data Strategy Practices, see https://strategy.data.gov/practices/].
    In support of its work, the SOS has developed a proposed set of 
desirable characteristics of data repositories for data resulting from 
Federally funded research. The proposed characteristics could apply to 
repositories operated by government or non-governmental entities. They 
draw from agency experience in developing and supporting data 
repositories and build on existing information for selecting 
repositories that agencies developed as part of their public access 
policies. Through public comment, the SOS aims to refine and develop a 
common set of characteristics that Federal R&D-funding agencies can use 
to support their Public Access and data sharing efforts.
    These characteristics are not intended to be an exhaustive set of 
design features for data repositories. Federal agencies would not plan 
to use these characteristics to assess, evaluate, or certify the 
acceptability of a specific data repository, unless otherwise specified 
for a particular agency program, initiative, or funding opportunity. 
Rather, the set of characteristics is intended to be used as a tool for 
agencies and Federally funded investigators when, for example, they 
are:
     Assisting Federally funded investigators in identifying 
data repositories to use for storing and providing access to research 
data (e.g., when funding agencies do not host the data and/or have not 
designated specific repositories for use);
     Identifying specific repositories that a Federal agency 
might designate for use for particular types of research data resulting 
from Federally funded research;

[[Page 3086]]

     Developing Federal agency repositories to store data 
resulting from Federally funded research;
     Informing external data repository developers and managers 
of the characteristics desired by Federal agencies for storing and 
preserving data resulting from Federally funded research;
     Evaluating data management plans that propose to deposit 
research data in a repository that is not operated by a Federal agency.
    Consistent with their Public Access Plans, SOS member agencies have 
proposed characteristics to help support discoverability, management, 
and sharing of research data, in a user-friendly manner, consistent 
with principles becoming widely adopted in the research community to 
make data findable, accessible, interoperable, and reusable (FAIR). 
[For information on the FAIR principles, see https://www.go-fair.org/fair-principles.] The proposed characteristics are intended to be 
consistent with criteria that are increasingly used by non-Federal 
entities to certify data repositories, such as ISO16363 Standard for 
Trusted Digital Repositories and CoreTrustSeal Data Repositories 
Requirements, so that repositories with such certifications would 
generally exhibit these characteristics. SOS member agencies also 
anticipate that many repositories without such certifications would 
exhibit them as well. While the desirable characteristics are intended 
to be enduring, Federal agencies might update them periodically to 
reflect changing expectations, rapid evolution of research and 
technology, and practices related to data management and sharing.
    This RFC, released on behalf of Federal agencies that are members 
of the SOS, aims to solicit public input on proposed characteristics 
for selecting or developing a repository for managing and sharing data 
that embody effective management and stewardship over data resulting 
from Federally funded research. Feedback obtained through this RFC will 
help to inform the development of coordinated Federal agency technical 
and policy guidance on repositories for research data.

Request for Comments

    Federal agencies are specifically requesting public comment on the 
Draft Desirable Characteristics of Repositories to Consider for 
Managing and Sharing Data Resulting from Federally Funded or Supported 
Research, found below. The proposed characteristics include ``Desirable 
Characteristics for All Data Repositories'' (Section I), as well as 
``Additional Considerations for Repositories Storing Human Data (even 
if de-identified)'' (Section II), found below. Note that Federal 
agencies are subject to additional requirements that must be met for 
repositories they manage or support, such as considerations of 
security, privacy, and accessibility.
    Response to this Notice is voluntary, and respondents are free to 
address any or all of the topics listed below and should not feel 
compelled to address all items:

 The proposed use and application of the desirable 
characteristics (as described in the ``Background'' section above)
 The appropriateness of the ``Desirable Characteristics for All 
Data Repositories'' (Section I) for data repositories that would store 
and provide access to data resulting from Federally-supported research, 
considering:
    [cir] Characteristics that are included
    [cir] Additional characteristics that should be included
 Appropriateness of the characteristics listed in the 
``Additional Considerations for Repositories Storing Human Data (even 
if de-identified)'' (Section II) delineated for repositories 
maintaining data generated from human samples or specimens, 
considering:
    [cir] Characteristics that are included
    [cir] Additional characteristics that should be included
 Considerations for any other repository characteristics which 
should be included to address the management and sharing of unique data 
types (e.g., special or rare datasets)
 The ability of existing repositories to meet the desirable 
characteristics
 Consistency of the desirable characteristics with widely used 
criteria or certification schemes for certifying data repositories
 Any other topic which may be relevant for Federal agencies to 
consider in developing desirable characteristics for data repositories.

DRAFT Desirable Characteristics of Repositories for Managing and 
Sharing Data Resulting From Federally Funded or Supported Research

I. Desirable Characteristics for All Data Repositories

    A. Persistent Unique Identifiers: Assigns datasets a citable, 
persistent unique identifier (PUID), such as a digital object 
identifier (DOI) or accession number, to support data discovery, 
reporting (e.g., of research progress), and research assessment (e.g., 
identifying the outputs of Federally funded research). The PUID points 
to a persistent landing page that remains accessible even if the 
dataset is de-accessioned or no longer available.
    B. Long-term sustainability: Has a long-term plan for managing 
data, including guaranteeing long-term integrity, authenticity, and 
availability of datasets; building on a stable technical infrastructure 
and funding plans; has contingency plans to ensure data are available 
and maintained during and after unforeseen events.
    C. Metadata: Ensures datasets are accompanied by metadata 
sufficient to enable discovery, reuse, and citation of datasets, using 
a schema that is standard to the community the repository serves.
    D. Curation & Quality Assurance: Provides, or has a mechanism for 
others to provide, expert curation and quality assurance to improve the 
accuracy and integrity of datasets and metadata.
    E. Access: Provides broad, equitable, and maximally open access to 
datasets, as appropriate, consistent with legal and ethical limits 
required to maintain privacy and confidentiality.
    F. Free & Easy to Access and Reuse: Makes datasets and their 
metadata accessible free of charge in a timely manner after submission 
and with broadest possible terms of reuse or documented as being in the 
public domain.
    G. Reuse: Enables tracking of data reuse (e.g., through assignment 
of adequate metadata and PUID).
    H. Secure: Provides documentation of meeting accepted criteria for 
security to prevent unauthorized access or release of data, such as the 
criteria described in the International Standards Organization's ISO 
27001 (https://www.iso.org/isoiec-27001-information-security.html) or 
the National Institute of Standards and Technology's 800-53 controls 
(https://nvd.nist.gov/800-53).
    I. Privacy: Provides documentation that administrative, technical, 
and physical safeguards are employed in compliance with applicable 
privacy, risk management, and continuous monitoring requirements.
    J. Common Format: Allows datasets and metadata to be downloaded, 
accessed, or exported from the repository in a standards-compliant, and 
preferably non-proprietary, format.
    K. Provenance: Maintains a detailed logfile of changes to datasets 
and metadata, including date and user, beginning with creation/upload 
of the dataset, to ensure data integrity.

[[Page 3087]]

II. Additional Considerations for Repositories Storing Human Data (Even 
if De-Identified)

    A. Fidelity to Consent: Restricts dataset access to appropriate 
uses consistent with original consent (such as for use only within the 
context of research on a specific disease or condition).
    B. Restricted Use Compliant: Enforces submitters' data use 
restrictions, such as preventing reidentification or redistribution to 
unauthorized users.
    C. Privacy: Implements and provides documentation of security 
techniques appropriate for human subjects' data to protect from 
inappropriate access.
    D. Plan for Breach: Has security measures that include a data 
breach response plan.
    E. Download Control: Controls and audits access to and download of 
datasets.
    F. Clear Use Guidance: Provides accompanying documentation 
describing restrictions on dataset access and use.
    G. Retention Guidelines: Provides documentation on its guidelines 
for data retention.
    H. Violations: Has plans for addressing violations of terms-of-use 
by users and data mismanagement by the repository.
    I. Request Review: Has an established data access review or 
oversight group responsible for reviewing data use requests.

Sean C. Bonyun,
Chief of Staff, Office of Science and Technology Policy.
[FR Doc. 2020-00689 Filed 1-16-20; 8:45 am]
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