Request for Information on the National Institutes of Health Draft Public Access Policy, 51537-51543 [2024-13373]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 89, Number 118 (Tuesday, June 18, 2024)]
[Notices]
[Pages 51537-51543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13373]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information on the National Institutes of Health 
Draft Public Access Policy

AGENCY: National Institutes of Health, HHS.

ACTION: Request for information.

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SUMMARY: The National Institutes of Health (NIH) is soliciting comments 
from the public on the NIH Draft Public Access Policy and two 
supplemental draft guidance documents regarding government use license 
and rights and costs for publications. The NIH Draft Public Access 
Policy builds upon NIH's long history of providing public access to 
scholarly publications resulting from the research it supports and 
proposes additional steps to accelerate access.

DATES: To ensure consideration, comments must be submitted in writing 
by August 19, 2024.

ADDRESSES: Comments may be submitted electronically to https://osp.od.nih.gov/comment-form-national-institutes-of-health-draft-public-access-policy/. Comments are voluntary and may be submitted 
anonymously. You may also voluntarily include your name and contact 
information with your response. Other than your name and contact 
information, please do not include in the response any personally 
identifiable information or any information that you do not wish to 
make public. Proprietary, classified, confidential, or sensitive 
information should not be included in your response. After the NIH 
Office of Science Policy (OSP) has finished reviewing the responses, 
the responses may be posted to the OSP website without redaction.

FOR FURTHER INFORMATION CONTACT: Hilary Leeds, J.D., Senior Policy 
Analyst for Public Access, Office of Science Policy, at (301) 496-9838 
or [email protected].

SUPPLEMENTARY INFORMATION:

Background

    Increasing access to publications resulting from NIH funding offers 
many benefits to the scientific community and the public who funded the 
underlying work. The ability for patients, families, and members of the 
public to access published findings resulting from NIH funding enables 
them to better understand and address the most critical public health 
concerns facing their communities. It also allows researchers, 
students, and health care

[[Page 51538]]

providers in all communities to have equitable access to such content. 
This access can accelerate future research, lead to collaboration, and 
allow interested readers and patients to keep up more closely with 
critical advances. Importantly, these goals also reflect NIH's 
commitment to responsible stewardship of the Nation's investment in 
biomedical research by improving transparency and accessibility of 
taxpayer-funded research.
    The NIH Public Access Policy,\1\ in effect since 2008, requires 
that NIH-supported researchers submit their final peer-reviewed 
manuscripts to the PubMed Central[supreg] digital archive of full-text 
biomedical literature upon acceptance for publication. NIH makes 
manuscripts freely available to the public after an allowable embargo 
period of not more than 12 months after the official date of 
publication. The 2008 Policy implements Public Law 110-161 \2\ and has, 
to date, resulted in more than 1.5 million articles reporting on NIH-
supported research being freely available to the public in PubMed 
Central.
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    \1\ https://sharing.nih.gov/public-access-policy/public-access-policy-overview#public-access-policy-details.
    \2\ https://www.congress.gov/110/statute/STATUTE-121/STATUTE-121-Pg1844.pdf.
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    On August 25, 2022, the Office of Science and Technology Policy 
(OSTP) released updated policy guidance (2022 OSTP Memorandum \3\) in 
an effort to further promote equity, advance trust in science, and 
continue to advance American scientific leadership. Following the 2022 
OSTP Memorandum, NIH released its Plan to Enhance Public Access to the 
Results of NIH-Supported Research (hereinafter ``NIH Public Access 
Plan'' or ``Plan'') in February 2023.\4\ The NIH Public Access Plan 
provided a roadmap for how NIH proposed to accelerate access to 
scholarly publications, consistent with the expectation to remove the 
currently allowable 12-month embargo period before public availability. 
Informed by public comments in response to the Plan, the NIH Draft 
Public Access Policy accommodates novel elements of the 2022 OSTP 
Memorandum related to scholarly publications.
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    \3\ https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf.
    \4\ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-091.html.
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Overview of Public Comments

    A total of 143 written public comments \5\ were received on the NIH 
Public Access Plan, released in 2023. In addition, NIH hosted a public 
listening session on the Public Access Plan in April 2023,\6\ and in 
November 2023, NIH sponsored a workshop held by the National Academies 
of Science, Engineering and Medicine (NASEM) on Enhancing Public Access 
to the Results of Research Supported by HHS.\7\ Commenters and 
attendees came from academic institutions, including institutional 
officials and researchers at various career stages, and professional 
associations (many of whom also publish academic journals). They also 
importantly included representatives of non-profit research 
organizations, general members of the public, publishers, patient 
advocates, health care organizations, advocacy organizations, and 
biotechnology/pharmaceutical companies.
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    \5\ https://osp.od.nih.gov/wp-content/uploads/2023/06/NIH_Public_Access_to_the_Results_of_NIH-Supported_Research_RFI_FINAL_508.pdf.
    \6\ https://osp.od.nih.gov/events/virtual-listening-session-on-the-nih-public-access-plan/.
    \7\ https://www.nationalacademies.org/our-work/enhancing-public-access-to-the-results-of-research-supported-by-the-department-of-health-and-human-services-a-workshop.
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    NIH considered all feedback to inform and develop a new NIH Draft 
Public Access Policy. Upon finalization, the new Policy will replace 
the current 2008 NIH Public Access Policy. Notably, commenters and 
attendees were generally supportive of updating the 2008 Policy to 
remove the embargo period, allowing for accelerated access to the 
results of NIH-funded research.

Discussion of Public Comments and Key Provisions of the NIH Draft 
Public Access Policy

    A discussion of the public comments on the NIH Public Access Plan 
and how they were incorporated into the NIH Draft Public Access Policy 
is provided below. This section outlines the 2008 Public Access 
Policy's approach on each issue, proposals in the NIH Public Access 
Plan, followed by Public Comments on the NIH Public Access Plan, and 
finally the approach proposed in the NIH Draft Public Access Policy.

Definition of ``Article''

    Current Public Access Policy: The current Public Access Policy does 
not have a general term or definition to describe the versions produced 
in the various stages of writing and publishing.
    NIH Public Access Plan: The Plan did not propose a term or 
definition to describe the versions produced in writing and publishing.
    Public Comments: Several commenters suggested clarity was needed to 
distinguish the official published version of a manuscript from 
previous draft versions, though no comments suggested a specific 
definition or term to refer to these various versions.
    NIH Draft Public Access Policy: The NIH Draft Public Access Policy 
includes a definition of ``article'' to describe, in general, the 
versions from the creation of the manuscript through the final 
published article.

Definition of ``Official Date of Publication''

    Current Public Access Policy: When determining the timing of public 
release of an article, NIH bases the official date of publication on 
the issue or ``print'' publication date.
    NIH Public Access Plan: For consistency with expectations under the 
NIH Policy for Data Management and Sharing (NIH DMS Policy) and to 
reflect current practice in scholarly communications, NIH proposed to 
interpret ``Official Date of Publication'' as the date on which the 
publisher first makes an article available, either online or in print. 
This is consistent with a relevant Frequently Asked Question (FAQ) \8\ 
on the NIH DMS Policy.\9\
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    \8\ https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm?anchor=56773.
    \9\ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html.
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    Public Comments: There were no public comments on the definition of 
``Official Date of Publication.'' Many commenters noted the importance 
of easing burden and providing clarity on methods of compliance.
    NIH Draft Public Access Policy: The NIH Draft Public Access Policy 
proposes to define ``Official Date of Publication'' as ``the date on 
which the article is first made available in final, edited form, 
whether in print or electronic (i.e., online) format,'' which is 
slightly modified from the proposal in the NIH Public Access Plan to be 
more precise. Consistent understanding about what is meant by an 
official date of publication between the NIH DMS Policy and NIH Public 
Access Policy will provide clarity to those complying with both 
policies. NIH notes that NIH's proposed implementation of public 
availability without embargo will take into account processing time 
that may be needed before public availability in PubMed Central.

Scope of the Public Access Policy

    Current Public Access Policy: The current Public Access Policy's 
scope includes the concept of ``direct'' funding by NIH. The scope of 
the current Public Access Policy is also not limited to manuscripts 
reporting research findings. Rather, the Policy's requirements apply

[[Page 51539]]

to any peer-reviewed manuscript that arises from direct funding from 
the NIH and is accepted for publication in a journal on or after April 
7, 2008. For example, a peer-reviewed manuscript that describes an 
infrastructure project that was NIH funded may be subject to the 
Policy, even if not reporting research findings.
    NIH Public Access Plan: The Plan did not discuss the proposed scope 
of the NIH Draft Public Access Policy regarding ``direct'' funding or 
other related details.
    Public Comments: Some public comments requested clarification on 
situations where NIH funding does not directly support the research 
reported in a publication or where researchers use NIH resources 
without NIH funding. Other comments suggested that only awardees above 
a certain funding threshold or level of contribution on a grant be 
subject to the Public Access Policy.
    NIH Draft Public Access Policy: The NIH Draft Public Access Policy 
proposes to adopt the current NIH Public Access Policy's scope and is 
intended to make available knowledge generated from NIH-supported 
discoveries. Accordingly, the NIH Draft Public Access Policy applies to 
any Manuscript \10\ accepted for publication in a journal that results 
from funding by NIH in whole or in part. NIH intends to clarify in FAQs 
that using NIH resources, such as datasets available through NIH 
repositories and physical resources and infrastructure supported by the 
NIH, when no NIH funds were used for the work upon which the Manuscript 
is based, does not subject a resulting Manuscript to the NIH Public 
Access Policy. However, NIH notes that some programs at NIH and 
specific agreements may add in such a requirement independent of the 
NIH Public Access Policy's scope.
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    \10\ Note that defined terms are capitalized throughout.
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    The NIH Draft Public Access Policy also applies regardless of 
whether non-NIH funds contributed to developing or writing the 
Manuscript. The applicability of the NIH Draft Public Access Policy 
depends on whether the Manuscript is the result of NIH funding in whole 
or in part and is not dependent on the funds that contributed to the 
writing of the Manuscript itself.
    Finally, the NIH Draft Public Access Policy, like the current 
Public Access Policy, does not limit its scope to Manuscripts reporting 
only on research (it can include, for example, a peer-reviewed 
manuscript that describes an infrastructure project that was funded by 
NIH).

Timeline of Public Access Policy Applicability

    Current Public Access Policy: Neither the current Public Access 
Policy nor the law that the Policy implements specifies an end date to 
the Policy's applicability to Manuscripts within scope of the 
Policy.\11\ This approach is consistent with publishing practices, in 
which publication often happens after the end of an award.
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    \11\ https://www.congress.gov/110/statute/STATUTE-121/STATUTE-121-Pg1844.pdf.
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    NIH Public Access Plan: The Public Access Plan did not indicate how 
long the Public Access Policy would be applicable to Manuscripts.
    Public Comments: There were no public comments on the Public Access 
Policy's potential applicability to publications arising after the 
closeout of the award. Some commenters requested guidance on how to 
comply with the Policy when NIH-supported researchers submit articles 
for publication long after their NIH funding has ended.
    NIH Draft Public Access Policy: NIH is not proposing an end date 
for applicability to Manuscripts arising out of awards. Non-compliance 
with the NIH Public Access Policy may be considered by NIH regarding 
future funding decisions for the recipient institution.

Policy Effective Date

    Current Public Access Policy: The current Public Access Policy 
became effective for manuscripts accepted for publication on or after 
April 7, 2008; and which arose from direct funding from an award active 
in FY 2008 or beyond, a contract signed on or after April 7, 2008, or 
from intramural research or an NIH employee.
    NIH Public Access Plan: The NIH Plan indicates ``NIH plans to 
update the NIH Public Access Policy no later than December 31, 2024, 
with an effective date no later than December 31, 2025,'' adhering to 
an expectation from the 2022 OSTP Memorandum.
    Public Comments: Some public comments on the proposed effective 
date, noted in the NIH Public Access Plan, argued for a two-year delay 
in the effective date to allow time for publishers (particularly 
smaller society-based publishers) to adjust. Some also suggested that 
the timeline for an effective policy was too aggressive but did not 
specify or suggest a specific delay. There were no comments regarding 
how the effective date should align with the NIH award cycle.
    NIH Draft Public Access Policy: Consistent with the current Public 
Access Policy, the NIH Draft Public Access Policy is proposed to become 
effective for Manuscripts accepted for publication on or after October 
1, 2025. This approach has the benefit of capturing all Manuscripts 
accepted for publication regardless of whether the award or contract is 
new or ongoing. NIH is committed to working with the research community 
to prepare for implementation of the final Policy.
    The proposed effective date, October 1, 2025, will follow the 
expectations of the 2022 OSTP Memorandum to be no later than the end of 
calendar year 2025.

Rights in Manuscripts

    Current Public Access Policy: Currently, the FAQs to the Public 
Access Policy describe how and when rights in manuscripts accrue and 
what may be transferred. NIH provides sample language an author or 
institution might add to a copyright agreement with a journal. In 
addition, authors submitting Manuscripts to PubMed Central must agree 
to the NIH Manuscript Submission (NIHMS) Statement \12\ that, in part, 
allows the Manuscript to be appropriately tagged and made available on 
the PubMed Central website. This ensures that Manuscripts are available 
in machine-readable formats that support accessibility \13\ and 
facilitate text mining.\14\
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    \12\ https://support.nlm.nih.gov/knowledgebase/article/KA-05252/en-us.
    \13\ https://www.ncbi.nlm.nih.gov/pmc/about/accessibility/.
    \14\ https://www.ncbi.nlm.nih.gov/pmc/tools/amdataset/.
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    NIH Public Access Plan: In the Public Access Plan, NIH said it 
would clarify how NIH-supported investigators may retain sufficient 
rights to NIH-supported peer-reviewed manuscripts. NIH proposed to 
develop language that NIH-supported investigators may use for 
submission with their peer-reviewed manuscripts to journals to retain 
rights to make the peer-reviewed manuscript available in PubMed Central 
without an embargo period.
    Public Comments: There were numerous public comments on rights 
retention. These comments ranged from suggesting that NIH require 
authors to retain rights to all versions of research products 
(including the preprint, the author-accepted manuscript, and the 
journal version of record) to advocating that NIH not provide guidance 
or sample language on rights retention as it will interfere with 
publisher practices. The most frequently observed responses referred 
only to the author accepted

[[Page 51540]]

manuscript (to be submitted to PubMed Central) and argued that either 
(1) NIH require authors to retain rights via the most open licenses 
(e.g., Creative Commons [CC] BY) or (2) NIH should not mandate rights 
retention or specific licenses but should allow authors to decide 
whether and how to retain their rights in the manuscript. Many comments 
were in favor of NIH publishing guidance around rights retention, 
including some suggestions to ease administrative burden by providing 
template language to be submitted alongside manuscript submission to 
the publisher.
    NIH Draft Public Access Policy: NIH proposes to focus on achieving 
the Policy's goals regarding rights in Manuscripts through minimally 
burdensome pathways. First, the NIH Draft Public Access Policy proposes 
to clarify that government use rights are given to NIH upon acceptance 
of funding. A statement granting NIH rights to make Manuscripts 
publicly available in PubMed Central upon the Official Date of 
Publication is proposed to be incorporated into Notices of Award and 
applicable contracts. This ensures it is understood that NIH's rights 
are automatically established at the acceptance of funding, without 
requiring funded recipients to take additional steps.
    Secondly, the NIH Draft Public Access Policy proposes that those 
submitting Manuscripts to PubMed Central will provide a license to NIH 
that mirrors the Government Use License as part of a revised Manuscript 
Submission Statement, granting NIH the right to (1) make Manuscripts 
publicly available in PubMed Central upon the Official Date of 
Publication and (2) make Manuscripts available in machine-readable 
formats to support accessibility and facilitate text mining, consistent 
with current practice.
    Beyond these measures, NIH does not propose requiring authors apply 
a particular license to their Manuscripts. A particular license is not 
needed to achieve the Policy's goal of making Manuscripts available 
without an embargo.
    In the Draft Guidance on Government Use License and Rights, NIH 
encourages authors to clearly communicate NIH's rights through a 
statement in the Manuscript itself. In this Guidance, NIH has proposed 
standardized language authors may choose to place in their Manuscripts.

Publication Costs

    Current Public Access Policy: According to the current NIH Public 
Access Policy FAQs, ``Publication costs, including author fees, may be 
charged to NIH grants and contracts on three conditions: (1) such costs 
incurred are actual, allowable, and reasonable to advance the 
objectives of the award; (2) costs are charged consistently regardless 
of the source of support; (3) all other applicable rules on 
allowability of costs are met.'' \15\ Importantly, even if such costs 
were not incurred during a specific period of performance of an award, 
an award may still be charged before its closeout for publication 
costs.
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    \15\ https://sharing.nih.gov/faqs#/public-access-policy?anchor=50507.
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    NIH Public Access Plan: NIH stated in the Public Access Plan the 
intent to continue to allow reasonable publication costs for all NIH-
supported or authored scholarly publications consistent with current 
policy and guidance. NIH proposed to continue monitoring trends in 
publication fees and policies to ensure that they remain reasonable and 
do not disproportionally burden one or more segments of the NIH-
supported community, and that opportunities to publish are equitable 
and consistent with NIH's strategic priorities.
    Public Comments: Many respondents argued that removal of the 
embargo would drive publishers to business models that charge fees to 
make articles openly and immediately available, and that as these fees 
rise, so will inequity for lower resourced institutions and 
investigators. Some publishers suggested that these models are the only 
way forward as subscriptions diminish. Others sought assurances that 
authors would be able to comply with the revised NIH Public Access 
Policy without cost through repository deposition models. Some 
publishers suggested that removal of the embargo and subsequent 
diminished subscriptions could have a significant negative effect on 
their operations, leading to limited choices of where to publish, which 
would limit accessibility.
    Many comments favored monitoring the costs of publications. Some 
suggestions included examining application budgets and annual reports 
to the NIH, working with publishers to understand publishing model and/
or discipline specific requirements, and exploring currently existing 
cost assessments. Some suggested that any appearance of dictating 
business models would be inappropriate and could interfere with a 
publisher's ability to remain in business.
    Several respondents perceived fees to make articles openly and 
immediately available to be too high and to lack transparency. Some of 
these comments encouraged NIH to cap publication-related costs. Several 
publishers argued that cost-capping could lead to an increase in 
``predatory'' publishing.
    Many argued that NIH should define which publication costs would be 
permissible under regulations and the Grants Policy Statement (GPS). 
Some suggested that it would be helpful to define ``reasonable'' costs, 
while others suggested that such definitions would be entirely context 
dependent and would necessarily evolve.
    NIH Draft Public Access Policy: In the NIH Draft Public Access 
Policy, NIH clarifies that compliance with the Policy is free. While 
allowable publication costs may be budgeted, as publishing itself may 
incur costs, NIH maintains a free pathway for compliance with the NIH 
Draft Public Access Policy by submission of the Manuscript to PubMed 
Central. This free pathway for policy compliance helps to support the 
goals of equitable public access. Additionally, the benefits of 
eliminating costs and delays in access to publications will likely be 
greatest for lower resourced institutions, researchers, and the public.
    The NIH Draft Public Access Policy notes that if authors are asked 
to pay a fee by a third party for submission of Manuscripts to PubMed 
Central, the NIH Draft Public Access Policy would not permit this fee 
to be paid from NIH funds because it is not a legitimate publication 
expense. The NIH Draft Public Access Policy indicates reasonable costs 
associated with publication that are allowable may be requested in the 
budget for the project as direct or indirect costs.
    The Draft Guidance on Publication Costs contains examples of 
unallowable costs, based on existing cost principles and existing 
sections of the GPS. Regarding the ability to pay publication costs 
after an award has ended, NIH cannot pay publication costs after 
closeout of an award (as recently affirmed in revisions to 2 CFR 
200.461 \16\). Points to Consider are provided for authors and 
institutions to inform whether a publication cost is reasonable.
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    \16\ https://www.federalregister.gov/documents/2024/04/22/2024-07496/guidance-for-federal-financial-assistance#sectno-reference-200.461.
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    NIH will continue to consider appropriate methods to monitor costs 
for potential impacts on relevant communities once the final Public 
Access Policy has been implemented and any downstream effects are more 
readily apparent.

[[Page 51541]]

Compliance and Enforcement

    Current Public Access Policy: The current NIH Public Access Policy 
notes that the awardee institution is responsible for complying with 
the terms and conditions of the award. Compliance may be achieved 
through submission of the Manuscript or through journals submitting 
Final Published Articles to PubMed Central based on existing 
agreements. NIH may take one or more enforcement actions, depending on 
the severity and duration of the non-compliance, in accordance with 
applicable statutes, regulations, and policies.
    NIH Public Access Plan: The Public Access Plan did not specify 
enforcement actions but rather outlined the pathways to compliance of 
submission of the Manuscript or Final Published Article.
    Public Comments: Many commenters requested that compliance with the 
NIH Public Access Policy be as simple as possible and not place undue 
burden on investigators. There were no public comments on the 
consequences for non-compliance.
    NIH Draft Public Access Policy: The NIH Draft Public Access Policy 
minimizes burden by proposing to adopt the same pathways to compliance 
as under the current Public Access Policy. It also reinforces the 
requirement to properly communicate and acknowledge federal funding in 
Manuscripts. Importantly, the NIH Draft Public Access Policy states 
that non-compliance with the requirement to properly communicate and 
acknowledge federal funding is itself a violation of the terms and 
conditions of award and also may result in non-compliance with the NIH 
Public Access Policy. It notes that non-compliance may delay non-
competing award processing and potentially affect future funding for 
the institution.

Accessibility and Understandability

    Current Public Access Policy: NIH currently makes content in PubMed 
Central available in accessible and machine-readable formats. In 
addition, NIH currently has multiple ways to make research and research 
results available to the public,\17\ including through press releases, 
the Public Health Relevance Statement in grant applications, and the 
Outcomes section in RePORTER.
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    \17\ https://grants.nih.gov/grants/how-to-apply-application-guide/forms-h/general/g.100-how-to-use-the-application-instructions.htm#6.
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    NIH Public Access Plan: The Public Access Plan proposed to continue 
making articles available in formats that allow for machine-readability 
and through assistive devices.
    Public comments: Public comments indicated that making information 
available is necessary but not sufficient to meet goals concerning 
equitable access. Consumers of the information resulting from NIH-
supported studies need to be able to process and understand what they 
are reading. Many public comments supported NIH's goals to make 
information machine-readable and available on assistive devices, but 
there were also comments about the need to enhance understanding, such 
as by translating articles into multiple languages and accompanying 
articles with plain language summaries.
    NIH Draft Public Access Policy: Accessibility of PubMed Central 
content is paramount and NIH will continue to make content accessible 
for those using assistive technologies. NIH appreciates comments noting 
that to make discoveries truly accessible to the public, information 
should be disseminated in ways that are meaningful and digestible. 
While NIH does not currently plan to require that authors develop or 
submit plain language summaries of Manuscripts or translate their 
content into languages other than English, as supporting technologies 
continue to develop, NIH will consider additional approaches to 
increase understanding of NIH-funded scientific research.

NIH Draft Public Access Policy

Purpose

    Increasing access to publications resulting from NIH funding offers 
many benefits to the scientific community and the public who funded the 
underlying work. The ability for patients, families, and members of the 
public to access published findings resulting from NIH funding enables 
them to better understand and address the most critical public health 
concerns facing their communities. It also allows researchers, 
students, and health care providers in all communities to have 
equitable access to such content. This access can accelerate future 
research, lead to collaboration, and allow interested readers and 
patients to keep up more closely with critical advances. Importantly, 
these goals also reflect NIH's commitment to responsible stewardship of 
the Nation's investment in biomedical research by improving 
transparency and accessibility of taxpayer-funded research.
    Per the NIH Public Access Policy, effective October 1, 2025, NIH is 
requiring Manuscripts to be submitted to PubMed Central upon acceptance 
for publication, for public availability without embargo upon the 
Official Date of Publication.

Definitions

    Manuscript: The author's final version that has been accepted for 
journal publication and includes all revisions resulting from the peer 
review process, including all associated tables, graphics, and 
supplemental material
    Final Published Article: The journal's authoritative copy, 
including journal or publisher copyediting and stylistic edits, and 
formatting changes
    Article: A general term that encompasses the versions resulting 
from writing and publishing, from creation of the manuscript through 
final published article in a journal
    Journal: A periodical publication that is either (1) included in 
the ``journal'' section of the National Library of Medicine (NLM) 
Catalog \18\ or (2) meets all of the following criteria:
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    \18\ https://www.ncbi.nlm.nih.gov/nlmcatalog/journals?term=periodical%5BPublication+Type%5D+AND+open%5BPublication+Status%5D.
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     Requirements for ISSN assignment;
     Content is issued over time under a common title;
     Is a collection of articles by different authors; and
     Is intended to be published indefinitely.
    Official Date of Publication: The date on which the article is 
first made available in final, edited form, whether in print or 
electronic (i.e., online) format

Scope and Effective Date

    The NIH Public Access Policy applies to any Manuscript accepted for 
publication in a journal, on or after October 1, 2025, that is the 
result of funding by NIH in whole or in part through:
     A grant or cooperative agreement, including training 
grants
     A contract,
     An Other Transaction,
     NIH intramural research, or
     The official work of an NIH employee.
    The NIH Public Access Policy applies regardless of whether the NIH-
funded principal investigator or project director is an author and 
regardless of whether non-NIH funds contributed to developing or 
writing the Manuscript. Upon the effective date, this Policy replaces 
the prior 2008 NIH Public Access Policy.

Requirements

    The Public Access Policy requires:
     Submission of an electronic version of the final peer-
reviewed Manuscript to

[[Page 51542]]

PubMed Central upon its acceptance for publication, for public 
availability without embargo upon the Official Date of Publication;
     An acknowledgment in the Manuscript and Final Published 
Article that satisfies the requirements in the NIH Grants Policy 
Statement regarding communicating and acknowledging federal 
funding,\19\ as well as analogous requirements for acknowledging 
federal funding as incorporated into Other Transactions and applicable 
contracts; and
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    \19\ NIH Grants Policy Statement 4.2.1 Acknowledgment of Federal 
Funding (https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.2.1_acknowledgement_of_federal_funding.htm) and 8.2.1 
Rights in Data (Publication and Copyrighting) (https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2.1_rights_in_data__publication_and_copyrighting_.htm).
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     When a Manuscript is submitted to NIH,\20\ providing NIH 
with a standard license that mirrors that of the Government Use License 
at 45 CFR 75.322(b),\21\ or its successor regulation, explicitly 
granting NIH the right to make the Manuscript publicly available 
through PubMed Central without embargo upon the Official Date of 
Publication.
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    \20\ This happens typically through the NIH Manuscript 
Submission (NIHMS) System.
    \21\ https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR78b08d9c95aad03/section-75.322.
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Government Use License and Rights

     By accepting NIH funding, the recipient grants to NIH, as 
the funding agency, a royalty-free, nonexclusive and irrevocable right 
to reproduce, publish, or otherwise use the work for federal purposes, 
and to authorize others to do so. This includes making Manuscripts 
publicly available in PubMed Central upon the Official Date of 
Publication. A statement that conveys this point is incorporated into 
Notices of Award and applicable contracts.
     NIH encourages inclusion of a statement in the Manuscript 
that indicates it is subject to the NIH Public Access Policy and that 
this means that NIH, as the funding agency, has the right to make the 
Manuscript publicly available in PubMed Central upon the Official Date 
of Publication. NIH provides standardized language in the Draft 
Guidance on Government Use License and Rights that authors may include 
in Manuscripts. Such a statement ensures transparency and awareness 
that NIH has the right to make the Manuscript available in PubMed 
Central without embargo upon the Official Date of Publication.
     Authors are not expected to provide rights to NIH to the 
Final Published Article. However, as noted in ``Compliance and 
Enforcement,'' NIH will accept submission of the Final Published 
Article to PubMed Central from journals with formal agreements with NLM 
as compliant with the Policy when its release meets public access 
requirements outlined in this Policy.

Costs

    Reasonable costs associated with publication that are allowable may 
be requested in the budget for the project as direct or indirect costs, 
as specified in the NIH Grants Policy Statement \22\ and as 
incorporated into Other Transactions and applicable contracts (see the 
Draft Guidance on Publication Costs for more information). Submission 
of Manuscripts to PubMed Central remains free for authors under the NIH 
Public Access Policy. If, during the course of the publication process, 
an author is asked to pay a fee for submission of the Manuscript to 
PubMed Central, such costs are not allowable.
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    \22\ https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.9_allowability_of_costs_activities.htm (See Publication 
and Printing Costs).
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Compliance and Enforcement

    Regarding submission to PubMed Central, compliance with the Policy 
may be achieved through either:

 Submission of the electronic version of the final peer-
reviewed manuscript (i.e., Manuscript as defined above) to PubMed 
Central upon its acceptance for publication, for public availability 
without embargo upon the official date of publication or
 Submission of the Final Published Article to PubMed Central 
from a journal with a formal agreement with NLM, upon the Official Date 
of Publication, for public availability without embargo

    Communicating and acknowledging federal funding enables a clear, 
public-facing indication of NIH funding in Manuscripts and Final 
Published Articles. Failure to include required acknowledgments may 
result in non-compliance with the NIH Public Access Policy, in addition 
to resulting in non-compliance with terms and conditions of funding 
regarding communicating and acknowledging federal funding.
    Non-compliance with the NIH Public Access Policy may be considered 
by NIH regarding future funding decisions for the recipient institution 
(e.g., as authorized in the NIH Grants Policy Statement, Section 8.5, 
Special Award Conditions and Remedies for Noncompliance (Special Award 
Conditions and Enforcement Actions)).\23\ Non-competing continuation 
grant awards are subject to a delay in award processing for non-
compliance with the NIH Public Access Policy.
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    \23\ https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.5_special_award_conditions_and_remedies_for_noncompliance__special_award_conditions_and_enforcement_actions_.htm.
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Draft Guidance on Government Use License and Rights

Purpose

    Federal agencies have, by law, certain rights to products resulting 
from federal funding. For works (e.g., manuscripts) under the 
Government Use License (45 CFR 75.322(b)), or its successor regulation, 
NIH ``reserves a royalty-free, nonexclusive and irrevocable right to 
reproduce, publish, or otherwise use the work for Federal purposes, and 
to authorize others to do so.'' These rights also apply as incorporated 
into Other Transactions and applicable contracts (e.g., the rights in 
data clause within the contract).
    NIH proposes this Draft Guidance to assist authors in navigating 
compliance with the NIH Public Access Policy with minimal burden. NIH 
also encourages authors to be clear with the journals to which they 
submit their Articles, to ensure journals understand that NIH has a 
right to make Manuscripts publicly available upon the Official Date of 
Publication.

Public Access Policy Requirements Related to Rights

    Upon accepting NIH funding, recipients grant to NIH the right to 
make Manuscripts arising from the funding publicly available in PubMed 
Central upon the Official Date of Publication, and this is affirmed via 
a statement in Notices of Award and applicable contracts.
    Authors approving Manuscripts for inclusion in PubMed Central must 
agree to a submission statement \24\ as part of the standard PubMed 
Central Manuscript submission process. Under the NIH Draft Public 
Access Policy, authors submitting a Manuscript to PubMed Central must 
provide NIH with a standard license that mirrors the Government Use 
License. This language will be included as part of this submission 
statement to PubMed Central and states:
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    \24\ https://support.nlm.nih.gov/knowledgebase/article/KA-05252/en-us.

    I hereby grant to NIH, a royalty-free, nonexclusive and 
irrevocable right to reproduce, publish, or otherwise use this work 
for Federal purposes, and to authorize others to do so. This grant 
of rights includes the right to create derivative works and make

[[Page 51543]]

the final, peer-reviewed manuscript publicly available upon the 
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Official Date of Publication.

    The language in this statement may evolve as regulations change, 
but it includes a grant of rights to NIH such that NIH may make the 
Manuscript publicly available in PubMed Central without an embargo, 
upon the Official Date of Publication.

Guidance for Communicating Rights in Manuscripts

    NIH highly encourages authors to be transparent when submitting 
Articles \25\ for consideration for publication by indicating to the 
journal or publisher that the Article is subject to the NIH Public 
Access Policy, and that this means that NIH, as the funding agency, has 
the right to make the Manuscript publicly available in PubMed Central 
upon the Official Date of Publication. NIH does not require that 
authors demonstrate to NIH what was communicated to publishers.
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    \25\ Term used because they represent the pre-peer review stage.
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    NIH suggests that authors submit the points above as a statement in 
the Manuscript. Such a statement may accompany the required funding 
acknowledgment. NIH provides the following sample language that may be 
included in the Manuscript:

    This manuscript is the result of funding in whole or in part by 
the National Institutes of Health. It is subject to the NIH Public 
Access Policy. Through acceptance of this federal funding, NIH has 
been given a right to make this manuscript publicly available in 
PubMed Central upon the Official Date of Publication, defined by NIH 
as ``The date on which the article is first made available in final, 
edited form, whether in print or electronic (i.e., online) format.

Draft Guidance on Publication Costs

Purpose

    NIH recognizes that authors publishing in peer-reviewed journals 
may incur associated costs, such as article processing charges (APCs) 
or other charges. Publication costs are allowable when they comport 
with the existing NIH cost principles.\26\ Cost principles clarify when 
costs should be allocated as direct versus indirect costs, and they 
clarify charges and fees that are allowable under the conditions 
outlined.
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    \26\ Grants Policy Statement Section 7.2. (https://grants.nih.gov/grants/policy/nihgps/HTML5/section_7/7.2_the_cost_principles.htm) and Section 7.9 (https://
grants.nih.gov/grants/policy/nihgps/HTML5/section_7/
7.9_allowability_of_costs_activities.htm).
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    This Draft Guidance clarifies publication costs that are not 
allowable based on existing cost principles that provide a framework 
for allowable publication costs. It also provides points to consider to 
assist authors and institutions as they assess whether publishing costs 
are reasonable.

Public Access Policy Requirements Related to Costs

    All costs must comport with 45 CFR 75, or its successor regulation, 
as implemented in NIH GPS Sections 7.2 and 7.9.1. These principles also 
apply as analogous requirements in Other Transactions and applicable 
contracts.
    The NIH Draft Public Access Policy clarifies that reasonable costs 
that are allowable may be requested in the budget for the project as 
direct or indirect costs, as specified in the NIH GPS and as 
incorporated into Other Transactions and applicable contracts. 
Importantly, the NIH Draft Public Access Policy also states that 
submission of Manuscripts to PubMed Central remains free for authors. 
Journal or publisher fees for submitting the Manuscript to PubMed 
Central that may arise during the course of the publication process are 
not allowable costs.

Other Unallowable Costs

    In addition to not allowing payment of fees to submit Manuscripts 
to PubMed Central, examples of other unallowable costs are listed below 
in the context of corresponding rules that can be found in the NIH GPS. 
This list may be updated as needed.

 Costs for services (e.g., peer review) for which there is no 
resulting publication are unallowable because costs must be chargeable 
or assignable in accordance with the relative benefits received (GPS 
7.2)
 Costs for which the institution already pays a fee that would 
cover publication costs (e.g., an agreement the institution has with a 
publisher whereby authors from that institution publish for free in 
exchange for subscription services) are unallowable because costs may 
not be double charged or inconsistently charged as both direct and 
indirect costs (GPS 7.4)
 Costs for publishing services that are charged differentially 
because an author's Manuscript is subject to the NIH Public Access 
Policy are unallowable because charges must be levied impartially on 
all items published by the journal, whether or not under a federal 
award (GPS 7.9.1, Publication and Printing Costs)
 Costs for services incurred after closeout of the award, even 
for a publication subject to the NIH Public Access Policy, are 
unallowable because the costs of publications must be incurred before 
closeout (GPS 7.9.1, Publication and Printing Costs)

Points To Consider for Authors and Institutions in Assessing Reasonable 
Costs

    As stated in Section 7.2 of the NIH GPS, a cost may be considered 
reasonable if the nature of the goods or services acquired or applied 
and the associated dollar amount reflect the action that a prudent 
person would have taken under the circumstances prevailing when the 
decision to incur the cost was made. NIH promotes reasonable 
publication costs to ensure an equitable system for publishing 
opportunities. However, establishing a particular threshold for what is 
reasonable may lead to inequitable outcomes in specific circumstances. 
While NIH may modify this approach in the future, NIH encourages 
researchers and institutions to consider, when determining whether 
costs are reasonable:

 Size of publication cost in relation to NIH award
 Other publications researchers may wish to produce during an 
award period
 Professional and institutional priorities
 Sustainability in terms of the library budget, laboratory 
budget, etc., if such costs were to be consistently paid

    In addition, NIH reiterates its Statement on Article Publication 
Resulting from NIH Funded Research,\27\ a 2017 NIH Guide Notice that 
encourages authors to publish papers arising from NIH-funded research 
in reputable journals. Fees paid to journals that have characteristics 
described in this Statement may be considered unreasonable.
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    \27\ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-011.html.
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    NIH seeks public comments on any aspect of the NIH Draft Public 
Access Policy and supplemental Draft Guidance.

    Dated: June 7, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-13373 Filed 6-17-24; 8:45 am]
BILLING CODE 4140-01-P