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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, HHS.

# ACTION:

Notice.

# SUMMARY:

The 2024 National Institutes of Health (NIH) Public Access Policy implements additional steps to accelerate free public access to scholarly publications resulting from the research that NIH supports, building upon NIH's long history of providing public access to research results.

# FOR FURTHER INFORMATION CONTACT:

                        Hilary Leeds, J.D., Senior Policy Analyst for Public Access, Office of Science Policy, at (301) 496-9838 or                         *SciencePolicy@od.nih.gov*.                    

# SUPPLEMENTARY INFORMATION:

## Background

Increasing access to publications resulting from the National Institutes of Health (NIH) funding offers many benefits to the scientific community and the public who funded the underlying research. When patients, families, and healthcare providers can access published findings resulting from NIH funding, they are able to better understand and address the most critical health concerns facing their communities. It also allows researchers, students, and members of the public 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 follow the latest advances more closely. Importantly, these goals reflect NIH's commitment to the responsible stewardship of the Nation's investment in biomedical research by improving transparency and accessibility of taxpayer-funded research, an essential component of fostering trust in research. NIH is issuing this updated Public Access Policy to further advance these goals by accelerating free public access to research results.

                    NIH has a long history of providing access to research products resulting from its funded research. The NIH Public Access Policy                     *https://sharing.nih.gov/​public-access-policy/​public-access-policy-overview*                     in effect since 2008, requires that NIH-supported researchers submit their final peer-reviewed manuscripts to the National Library of Medicine's PubMed Central® digital archive of full-text biomedical and life sciences journal literature upon acceptance for publication, to be made 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*https://www.congress.gov/​110/​statute/​STATUTE-121/​STATUTE-121-Pg1844.pdf,*                     which was made a legislative mandate for FY 2009 and beyond by Public Law 111-8*https://www.govinfo.gov/​content/​pkg/​PLAW-111publ8/​pdf/​PLAW-111publ8.pdf*. The Policy 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.                

                    On August 25, 2022, the White House Office of Science and Technology Policy (OSTP) released updated policy guidance (2022 OSTP Memorandum                     *https://www.whitehouse.gov/​wp-content/​uploads/​2022/​08/​08-2022-OSTP-Public-Access-Memo.pdf*) to all federal agencies with research and development expenditures 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                     *https://grants.nih.gov/​grants/​guide/​notice-files/​NOT-OD-23-091.html*                     in February 2023 (hereafter, the NIH Public Access Plan) and its Draft Public Access Policy                     *https://www.federalregister.gov/​documents/​2024/​06/​18/​2024-13373/​request-for-information-on-the-national-institutes-of-health-draft-public-access-policy*                     in June 2024 (NIH Draft Public Access Policy). The NIH Public Access Plan and Draft Public Access Policy provided a roadmap for how NIH proposed to accelerate access to scholarly publications, consistent with the government-wide expectation to remove the 12-month embargo period before public availability. This 2024 NIH Public Access Policy is consistent with the expectations of the 2022 OSTP Memorandum regarding scholarly publications and is informed by all public feedback, including comments submitted in response to the NIH Draft Public Access Policy.                

## Overview of Public Comments

                    A total of 144 written public comments                     *https://osp.od.nih.gov/​wp-content/​uploads/​2024/​10/​Compiled-Public-Comments-on-RFI-on-the-NIH-Draft-Public-Access-Policy-508C.pdf*                     were received in response to the NIH Draft Public Access Policy. Written comments were received from a variety                           ( print page 102920)                        of constituencies, including those from universities, professional associations, nonprofit organizations, and publishers. In addition, NIH hosted a public listening session                     *https://osp.od.nih.gov/​events/​virtual-listening-session-on-the-nih-public-access-plan/​*                     on the NIH Public Access Plan in April 2023, and in November 2023, NIH sponsored a workshop                     *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*                     held by the National Academies of Sciences, Engineering and Medicine (NASEM) on Enhancing Public Access to the Results of Research Supported by the U.S. Department of Health and Human Services (HHS). Commenters and attendees included academic institutional officials, researchers at various career stages, patient advocates, publishers, and officials from professional associations, many of whom also publish academic journals.                

NIH reviewed and considered all feedback to inform and develop the 2024 NIH Public Access Policy. Upon the listed effective date, the new Policy replaces the 2008 NIH Public Access Policy.

## Discussion of Public Comments

A discussion of the public comments on the NIH Draft Public Access Policy, organized by general topic or theme, is provided below. Each section outlines the 2008 NIH Public Access Policy's approach on each issue, proposals in the NIH Draft Public Access Policy, public comments on the NIH Draft Public Access Policy, and the approach in the 2024 NIH Public Access Policy (also referred to as the Policy).

### Definitions of Article, Manuscript, and Final Published Article

*2008 NIH Public Access Policy:*                     The 2008 NIH Public Access Policy did not have a general term or definition to describe the versions produced in the various stages of writing and publishing. Frequently Asked Questions (FAQs) associated with the 2008 NIH Public Access Policy expanded on some useful terms, such as Final Peer-Reviewed Manuscript and Final Published Article.                

*NIH Draft Public Access Policy:*                     The NIH Draft Public Access Policy included a definition of Article to describe, in general, the versions from the creation of the draft through the Final Published Article. It also included definitions of Manuscript, Final Published Article, Journal, and Official Date of Publication (described further in its own section).                

*Public Comments:*                     Although some comments supported the Draft Public Access Policy definitions of Article and Manuscript, other comments suggested that these terms were used inconsistently. There were many suggestions to define terms more clearly. Some suggestions included using other sources for definitions, such as the NISO Journal Article Version recommendations and the National Science Foundation's Public Access Plan's terms. Some comments suggested other replacement definitions. Some comments suggested that articles should not be considered Final Published Articles until the compilation of a volume or issue.                

*2024 NIH Public Access Policy:*                     To communicate clearly and transparently, the Policy includes the definitions of two precise terms: Author Accepted Manuscript and Final Published Article. Each term is uniquely and consistently used throughout the Policy. In the Policy, the term Final Published Article represents the journal's authoritative copy, even prior to the compilation of a volume or issue or the assignment of associated metadata.                

Because PubMed Central accepts submissions of the article from both the author (Author Accepted Manuscript) and journal (Final Published Article), the term “article” is still generally used here in this preamble to the Policy to refer to both Author Accepted Manuscripts and the Final Published Articles that are submitted to PubMed Central. However, it has been removed from the Policy itself. In addition, the Guidance on Government Use License and Rights includes the term Submitted Manuscript, as this Guidance discusses the process of submitting articles to be considered for publication in journals.

### Definition of Official Date of Publication

*2008 NIH Public Access Policy:*                     When determining the timing of public release of a manuscript, NIH based the official date of publication on the later of the electronic or print publication date.                

*NIH Draft Public Access Policy:*                     The NIH Draft Public Access Policy defined 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.”                

*Public Comments:*                     It was unclear to some if the NIH Draft Public Access Policy applied to an article upon its acceptance in a journal or upon its publication. Some comments suggested that the Official Date of Publication should refer to the point when an article has been issued pagination or an online article number if that journal does not issue pagination.                

*2024 NIH Public Access Policy:*                     The 2024 NIH Public Access Policy applies to Author Accepted Manuscripts. When determining the release of an Author Accepted Manuscript for public availability, the definition of Official Date of Publication is applicable. NIH has revised the definition of Official Date of Publication to be “the date on which the Final Published Article is first made available in final, edited form, whether in print or electronic (                    *i.e.,*                     online) format.” This clarifies how NIH determines when an Author Accepted Manuscript should be made publicly available, which is not dependent on the compilation of a volume or issue or the assignment of associated metadata, as reflected in the revised definition of Final Published Article.                

                    In addition, the definition of the Official Date of Publication is consistent with expectations under the NIH Policy for Data Management and Sharing (DMS Policy                     *https://grants.nih.gov/​grants/​guide/​notice-files/​NOT-OD-21-013.html*). Aligning definitions across the NIH DMS Policy and the updated NIH Public Access Policy provides consistency and clarity to those researchers who are subject to both policies. These modifications and clarifications are aligned with current practice in scholarly communications.                

### Scope of the Public Access Policy

*2008 NIH Public Access Policy:*                     The 2008 NIH Public Access Policy's scope included the concept of “direct” funding by NIH. The scope of the 2008 NIH Public Access Policy was not limited to articles reporting research findings. Rather, the 2008 Policy's requirements applied to any peer-reviewed article that arose from direct NIH funding and was accepted for publication in a journal on or after April 7, 2008. For example, a peer-reviewed article that arose from NIH funding that described an infrastructure project may have been subject to the 2008 Policy, even if not reporting research findings.                

*NIH Draft Public Access Policy:*                     The NIH Draft Public Access Policy adopted the 2008 NIH Public Access Policy's scope. Accordingly, the NIH Draft Public Access Policy applied to any Manuscript accepted for publication in a journal that results from funding by NIH in whole or in part. The applicability of the NIH Draft Public Access Policy depended upon whether the Manuscript was the result of NIH funding in whole or in part and was not dependent on whether non-NIH funds contributed to developing or writing the Manuscript itself. In addition, the NIH                           ( print page 102921)                        Draft Public Access Policy's applicability was based on the Manuscript's acceptance date, regardless of when the award from which the article resulted was funded.                

Finally, the NIH Draft Public Access Policy, like the 2008 NIH Public Access Policy, did not limit its scope to Manuscripts reporting only on research (it included, for example, a peer-reviewed article that resulted from NIH funding and described an infrastructure project).

*Public Comments:*                     Some comments requested clarification of the scope or suggested that the scope of the Policy be limited to original research articles. In addition, some comments suggested that the Policy should apply to the Version of Record rather than the Manuscript. Comments suggested that the Version of Record is more reliable as it contains post-publication corrections, for example. Some also suggested that the Policy should only apply to grants with a minimal funding threshold. Others suggested that NIH create a fund to help pay for publication costs for articles related to ongoing and closed awards.                

Some comments asked for additional clarification on what is encompassed in the term “Supplemental Material” and if non-peer-reviewed written products, such as reviews, perspectives, commentaries, and editorials, were within scope of the Policy.

*2024 NIH Public Access Policy:*                     The Policy maintains the scope of the NIH Draft Public Access Policy. Specifically, the Policy applies to final, peer-reviewed articles (                    *i.e.,*                     Author Accepted Manuscripts) accepted for publication in a journal on or after the Effective Date (December 31, 2025) that result from NIH funding in whole or in part. Supplemental Material are widely understood to be material included with the publication that support the publication (                    *e.g.,*                     detailed methods, additional figures).                

Importantly, NIH has a long history of ensuring the accuracy and integrity of the scholarly communication record maintained in its biomedical literature services over time by including post-publication updates made through correction, retraction, and/or an expression of concern. NIH creates links in PubMed Central between citations for original articles and citations for post-publication updates based on information published by the journal. All updated or retracted articles in PubMed Central are clearly identified as such by a prominent banner and watermark. PubMed Central also links to the Final Published Article on the journal website whenever possible.

### Duration of Public Access Policy Applicability

*2008 NIH Public Access Policy:*                     Neither the 2008 NIH Public Access Policy nor the law that made the 2008 Policy a requirement for FY 2009 and beyond                     *https://www.govinfo.gov/​content/​pkg/​PLAW-111publ8/​pdf/​PLAW-111publ8.pdf*                     specifies an end date to the 2008 Policy's applicability. This approach is consistent with publishing timelines, in which publication often happens after the end of an award.                

*NIH Draft Public Access Policy:*                     NIH did not propose an end date for applicability to Manuscripts resulting from awards.                

*Public Comments:*                     Some comments asked for clarification and guidance on how publication costs may be supported after closeout of an award. Some suggested that NIH find a way to allow awardees to use NIH funds to pay publication costs for articles subject to the Policy after closeout.                

*2024 NIH Public Access Policy:*                     The law that made the 2008 Policy a requirement for FY 2009 and beyond does not have an end date for the Policy's applicability. The 2024 NIH Public Access Policy, when effective, replaces the 2008 NIH Public Access Policy, which already applies to final, peer-reviewed accepted articles resulting from NIH funding for ongoing and closed awards. Therefore, the requirement of continued applicability is not new, and, consistent with the law and the 2008 NIH Public Access Policy, the 2024 NIH Public Access Policy does not include an end date for applicability of the Policy to Author Accepted Manuscripts within scope. Costs are discussed below in a separate section.                

### Policy Effective Date

*2008 NIH Public Access Policy:*                     The 2008 NIH 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 Draft Public Access Policy:*                     The NIH Draft Public Access Policy was proposed to become effective for Manuscripts accepted for publication on or after October 1, 2025.                

*Public Comments:*                     Several comments expressed preference for an Effective Date on the latest date such policies should be effective as outlined in the 2022 OSTP Memorandum, December 31, 2025. These comments suggested that the additional time would allow for better planning, communication, and additional opportunities for training for Policy compliance. It was suggested that this would also allow more time to renegotiate submission agreements between journal publishers and the National Library of Medicine. Other comments supported an Effective Date of October 1, 2025.                

Some comments suggested that the Policy should apply only to articles resulting from awards made after the Effective Date.

Comments requested clear communications around how the Policy would be initially implemented. Specific comments sought clarification on whether the Policy would apply retroactively and whether it would apply to draft or peer-reviewed articles that were not yet published as of the Policy's Effective Date. Additionally, some comments asked NIH to publish a clear implementation plan and provide opportunity for public comment on the implementation plan.

*2024 NIH Public Access Policy:*                     The Policy adopts an Effective Date of December 31, 2025. This approach is responsive to public comments and allows for additional time for affected groups and institutions to plan and prepare for the implementation of the Policy, while still being consistent with the 2022 OSTP Memorandum.                

The Policy applies to Author Accepted Manuscripts accepted on or after December 31, 2025, regardless of when the award was made that resulted in the Author Accepted Manuscript. This approach avoids a situation where the 2008 NIH Public Access Policy is in effect at the same time as the 2024 Policy. Such a situation could have led to administrative burden in tracking which policies apply to publications produced under different awards and confusion for readers, with some articles being made public without an embargo while other newly published articles would have an embargo applied.

NIH recognizes that some implementation questions might arise around the Effective Date. NIH anticipates that such issues are time-limited, and NIH is committed to working with the research community to prepare for implementation of the updated Policy.

### Rights in Author Accepted Manuscripts, Including Creating Derivative Works

*2008 NIH Public Access Policy:*                     The FAQs for the 2008 NIH Public Access Policy described how and when rights in articles accrue and what rights may be transferred. NIH provided sample language an author or institution may have added to a copyright agreement                           ( print page 102922)                        with a journal. In addition, authors depositing Manuscripts in PubMed Central must agree to the NIH Manuscript Submission (NIHMS) Statement that, in part, allows the Manuscript to be appropriately tagged and made available on PubMed Central. This ensures that all PubMed Central articles are available in machine-readable formats that support accessibility                     *https://www.ncbi.nlm.nih.gov/​pmc/​about/​accessibility/​*                     and facilitate text mining                     *https://pmc.ncbi.nlm.nih.gov/​tools/​amdataset/​#use.*

*NIH Draft Public Access Policy:*                     NIH focused on achieving the NIH Draft Public Access Policy's goals regarding rights for Manuscripts through minimally burdensome pathways. First, the NIH Draft Public Access Policy clarified that, upon the acceptance of funding, government use rights are granted to NIH. NIH proposed incorporating a statement granting NIH the right to make Manuscripts publicly available in PubMed Central upon the Official Date of Publication into Notices of Award and applicable contracts. This would help clarify that NIH's rights would be automatically established at the acceptance of funding, without requiring funded recipients to take additional steps.                

Secondly, the NIH Draft Public Access Policy proposed that authors depositing Manuscripts in PubMed Central would provide a license to NIH that mirrored the Government Use License as part of a revised Manuscript Submission Statement, granting NIH the rights to 1) make Manuscripts publicly available in PubMed Central upon the Official Date of Publication and 2) create derivative works in order to make Manuscripts available in machine-readable formats to support accessibility and facilitate text mining, consistent with current practice.

Beyond these measures, NIH did not propose requiring authors to apply a particular license to their Manuscripts.

In the Draft Guidance on Government Use License and Rights, NIH encouraged authors to clearly communicate NIH's rights through a statement in the Manuscript itself. In this Guidance, NIH proposed sample language for authors to place in their Manuscripts if desired.

*Public Comments:*                     NIH received many comments on rights. Many comments were broadly supportive of the draft language of the license that would be provided to NIH upon acceptance of award, while many others were broadly opposed. Some comments supported including NIH's rights in award conditions as being fully consistent with the government use rights. Others questioned the legal bases for NIH's proposal and suggested it could restrict an author's ability to determine how their works will be reused. Others requested clarification around the scope of NIH's rights, such as whether the license could prevent authors from depositing their articles in institutional repositories.                

Regarding the proposed language for the standard license when depositing Manuscripts in PubMed Central, comments were similarly split between support and opposition. Some suggested that the standard language added consistency and minimized confusion for those who are depositing, while others suggested that the language did not help authors understand their rights. Some were also confused as to how this language differed from the suggested language that was provided for authors to include in the article.

Comments were divided on the inclusion of the proposed license to allow for creating derivative works. Many supported the proposed language and indicated that it helped ensure accessibility, make critical information more widely available, and allow for machine readability. Many further suggested edits to the license and use statements that would grant rights to the full public reuse of the Manuscripts, with appropriate attribution. Those in opposition asserted that the proposal was not in alignment with the Government Use License and could undermine existing copyright agreements and the safeguards that publishers provide. Some also stated that the ability to create derivative works could undermine the integrity of the scientific record. Others suggested that if NIH were to include the ability to create derivative works in the license, there should be additional clarifications around specific use cases and limitations, providing adequate attribution to authors, and a way to enforce only appropriate uses.

*2024 NIH Public Access Policy:*                     The Policy includes relevant language about NIH's rights to make Author Accepted Manuscripts available in PubMed Central without embargo upon the Official Date of Publication. NIH reiterates that this does not mean that NIH has rights to the Final Published Article, as defined in the Policy, but only to the Author Accepted Manuscript, as defined in the Policy.                

The Policy also requires that those depositing Author Accepted Manuscripts in PubMed Central agree to a revised Manuscript Submission Statement reiterating NIH's right to post such Author Accepted Manuscripts without embargo upon the Official Date of Publication. The language for this statement, as included in the Guidance on Government Use License and Rights, has been modified from the Draft Public Access Policy to remove the phrase “create derivative works.” Because NIH had not intended the language to convey what comments suggested regarding the potential to compromise scientific integrity, NIH has removed the phrase. NIH will, however, continue using features, existing or to-be-developed, that ensure accessibility and usability. NIH also reserves the right to, in the future, reasonably interpret statutory and/or regulatory language to permit uses of content that are consistent with copyright law, that provide value to users, and that are considered to be in line with practices of the time.

Regarding comments that proposed NIH should provide the public with full reuse rights through explicit language about reuse of the work for any purpose with attribution, NIH notes that such language is akin to authors providing NIH with a particular license. As stated in the NIH Draft Public Access Policy, NIH does not believe that a particular license is needed to achieve the Policy's goals.

Finally, NIH clarifies that the Policy does not prevent authors from depositing their Author Accepted Manuscripts into institutional repositories, as long as Author Accepted Manuscripts are also deposited in PubMed Central per the Policy.

### Publication Costs

*2008 NIH Public Access Policy:*                     According to the 2008 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.” Importantly, even if such costs were not incurred during a specific period of performance of an award, an award may still be charged for publication costs before its closeout.                

*NIH Draft Public Access Policy:*                     In the NIH Draft Public Access Policy, NIH clarified that compliance with the Draft Policy is free. NIH proposed maintaining a free pathway for compliance through depositing the Manuscript in PubMed Central.                

                    The NIH Draft Public Access Policy noted that if authors were asked to pay a third-party fee for the submission of Manuscripts to PubMed Central, the NIH Draft Public Access Policy would not permit this fee to be paid from NIH                           ( print page 102923)                        funds because it is not a legitimate publication expense. The NIH Draft Public Access Policy indicated reasonable costs associated with publication that were allowable may be requested in the budget for the project as direct or indirect costs.                

                    The Draft Guidance on Publication Costs contained examples of unallowable costs, based on cost principles and the NIH Grants Policy Statement (GPS). Regarding the ability to pay publication costs after an award has ended, the Draft Guidance stated that NIH cannot pay publication costs after closeout of an award (as affirmed in revisions to 2 CFR 200.461*https://www.federalregister.gov/​documents/​2024/​04/​22/​2024-07496/​guidance-for-federal-financial-assistance#sectno-reference-200.461*). Points to Consider for Authors and Institutions in Assessing Reasonable Costs were included in the Draft Guidance on Publication Costs.                

*Public Comments:*                     NIH received many comments on costs. There were comments that supported the free pathway to compliance, while other comments suggested that framing it as such undermines the efforts of publishers and could disrupt revenue streams. Some of these comments suggested that the Policy could impact publication quality, cause shifts in journal models (                    *e.g.,*                     subscription- or article processing charge (APC)-based), or broadly increase APCs. Some suggested that smaller publishers, such as those supported by professional societies, will be particularly impacted by the Policy. Comments also expressed uncertainty about whether compliance with the Policy would require authors to pay journals to make their articles available immediately upon publication.                

Comments both supported and opposed the information in the Draft Guidance on Publication Costs. Those supporting NIH's approach suggested that the Guidance would allow for the best use of funds and increase access to scientific research overall. Others proposed that NIH also cover fees related to other aspects of publishing, such as the peer review process and copyediting, as well as fees associated with novel ways of making the results of NIH funding publicly available.

Many requested clarification on allowable costs and provided some specific suggestions and comments about circumstances that could warrant the use of NIH funds. Some suggested that NIH should add factors about why authors might choose to pay a fee to the Points to Consider for Authors and Institutions in Assessing Reasonable Costs (in the Draft Guidance on Publication Costs).

Other comments proposed that NIH pay for publication costs after closeout of the award and that this approach should be consistent across federal agencies. Comments also suggested that NIH should provide additional resources and guidance to underserved populations, such as researchers from historically excluded backgrounds, early-stage investigators, and researchers from lower-resourced institutions.

*2024 NIH Public Access Policy:*                     First, NIH reiterates that compliance with the Policy does not require the payment of an open access fee to a journal.                

NIH also reiterates that the free pathway to compliance can be achieved by depositing the Author Accepted Manuscript into PubMed Central for public availability upon the Official Date of Publication without embargo.

NIH recognizes and understands that publishing itself is not free. NIH has developed Guidance on Publication Costs to guide institutions and authors when budgeting for and paying allowable and reasonable publication costs. The available compliance pathways of both the free deposition of the Author Accepted Manuscript to PubMed Central and also the journal deposition of the Final Published Article to PubMed Central support equity in publishing opportunity and, in particular, author choice. Importantly, through this Policy, NIH does not prevent authors from publishing findings resulting from NIH funding in journals that do not make their content immediately, publicly available, as long as the Author Accepted Manuscript is deposited in PubMed Central for public availability upon the Official Date of Publication. In this way, NIH promotes author choice in journal selection.

Regarding APCs and potential impacts, NIH recognizes that it is unclear how and to what extent publishing costs will be affected by NIH's and the government-wide policies that ensure taxpayer access to the results of the research they funded without embargo. NIH will continue to consider appropriate methods to monitor costs for potential impacts on relevant communities once the Policy has been implemented and any downstream effects are more readily apparent.

The Guidance on Publication Costs outlines key factors for allowability and Points to Consider for Authors and Institutions in Assessing Reasonable Costs. NIH has clarified some areas of the Draft Guidance on Publication Costs in response to comments received.

The GPS does not limit allowable costs only to articles that are subject to the Policy. NIH acknowledges that the public dissemination of results from NIH funding does not occur only through peer-reviewed publications. Models for sharing research findings are evolving and allowable costs may be requested for publicly disseminating works reporting on the results of NIH funding that are not subject to the NIH Public Access Policy. NIH notes, however, that the unallowable costs listed in the Guidance on Publication Costs continue to apply, and works must be made publicly available to qualify for costs.

NIH also makes clear that institutions, through their policies, may choose how to allot benefits under agreements with publishers and use NIH funds for publishing in ways that are otherwise allowable and ensure direct and indirect costs are charged consistently, regardless of the source of funds.

NIH notes that the use of institutional resources, such as library services, to aid in Policy compliance is not only permitted but encouraged.

                    NIH cannot allow costs to be paid from an award after its closeout or from a contract after it is expired. However, costs for publication may be charged after the period of performance and prior to closeout (                    *i.e.,*                     during the 120-day liquidation period). These costs must only be for the originally approved activities and must not be associated with any new work performed outside of the period of performance.                

Finally, NIH has added some additional considerations to the Points to Consider for Authors and Institutions in Assessing Reasonable Costs that address concerns that the points were only outlining reasons not to pay a fee. NIH promotes consideration of all relevant factors when authors and institutions are deciding whether costs are reasonable in particular circumstances.

### Compliance and Enforcement

*2008 NIH Public Access Policy:*                     The 2008 NIH Public Access Policy noted that the awardee institution is responsible for complying with the terms and conditions of the award. Compliance could be achieved through submission of the article by the author or journal to PubMed Central. NIH could take one or more enforcement actions depending on the severity and duration of the noncompliance, in accordance with applicable statutes, regulations, and policies.                

*NIH Draft Public Access Policy:*                     The NIH Draft Public Access Policy adopted the same pathways to compliance as the                           ( print page 102924)                        2008 NIH Public Access Policy. It also reinforced the requirement to properly communicate and acknowledge federal funding in articles. Importantly, the NIH Draft Public Access Policy stated that noncompliance with the requirement to properly communicate and acknowledge federal funding is itself a violation of the terms and conditions of award and also could result in noncompliance with the NIH Public Access Policy. It noted that non-competing continuation grant awards are subject to a delay in award processing and that noncompliance may affect future funding for the institution.                

*Public Comments:*                     Some comments asked whether submission to PubMed Central would be the responsibility of the journal or the author and how compliance with the Policy would be monitored. Others asked for clarification around the flexibility of depositing Manuscripts immediately upon acceptance in PubMed Central, given processing times and other unforeseeable delays.                

*2024 NIH Public Access Policy:*                     Compliance with the Policy is the responsibility of the institution, but, as noted in the Policy, compliance may be achieved through the pathway of the journal's submission of the Final Published Article to PubMed Central. NIH intends to continue monitoring compliance through existing processes. The 2024 NIH Public Access Policy outlines additional information on compliance and enforcement for awards, contracts, Other Transaction agreements, and NIH employees.                

Regarding processing times, as noted in the NIH Draft Public Access Policy, implementation accounts for processing time that may be needed before public availability in PubMed Central. When Author Accepted Manuscripts are deposited into PubMed Central, an NIH Manuscript Submission Identifier (NIHMSID) may be used temporarily until the submission process is complete and a PubMed Central Identifier (PMCID) is assigned.

### Accessibility and Understandability

*2008 NIH Public Access Policy:*                     NIH currently makes content in PubMed Central available in accessible and machine-readable formats. In addition, NIH has multiple ways to make research results available to the public, including through press releases and the Public Health Relevance Statement and the Outcomes section in RePORTER.                

*NIH Draft Public Access Policy:*                     The Draft Policy noted that, as supporting technologies continue to develop, NIH would consider additional approaches to increase understanding of NIH-funded scientific research.                

*Public Comments:*                     Some comments suggested that the Draft Public Access Policy would increase accessibility of NIH research. Others noted that plain language summaries could enhance understandability.                

*2024 NIH Public Access Policy:*                     Accessibility of PubMed Central content is paramount, and NIH will continue to make content accessible for those using assistive technologies. PubMed Central continues to improve the user experience and make its content more perceivable, operable, understandable, and robust, guided in part by feedback from those who use 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. NIH is regularly looking for ways to promote the sharing of the results of its funded research, whether through press releases, websites, summary information on awards in RePORTER, or other means.                

## NIH Public Access Policy

## Purpose

Increasing access to publications resulting from National Institutes of Health (NIH) funding offers many benefits to the scientific community and the public who funded the underlying research. When patients, families, and healthcare providers can access published findings resulting from NIH funding, they are able to better understand and address the most critical health concerns facing their communities. It also allows researchers, students, and members of the public 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 follow the latest advances more closely. Importantly, these goals also reflect NIH's commitment to the responsible stewardship of the Nation's investment in biomedical research by improving transparency and accessibility of taxpayer-funded research, an essential component of fostering trust in research.

To achieve these goals, the NIH Public Access Policy requires Author Accepted Manuscripts accepted for publication in a journal, on or after December 31, 2025, to be submitted to PubMed Central upon acceptance for publication, for public availability without embargo upon the Official Date of Publication.

## Definitions

*Author Accepted 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, even prior to the compilation of a volume or issue or the assignment of associated metadata.                

*Journal:*                     A periodical publication that is either (1) included in the “journal” section of the National Library of Medicine (NLM) Catalog                     *https://www.ncbi.nlm.nih.gov/​nlmcatalog/​journals*                     or (2) meets all of the following criteria:                
    - 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 Final Published 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 Author Accepted Manuscript accepted for publication in a journal, on or after December 31, 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 Author Accepted Manuscript. Upon the Effective Date, this Policy replaces the 2008 NIH Public Access Policy.

## Requirements

The NIH Public Access Policy requires:
    - Submission of an electronic version of the Author Accepted Manuscript to PubMed Central upon its acceptance for publication for public availability without embargo upon the Official Date of Publication;       ( print page 102925)      
    - An acknowledgment in the Author Accepted Manuscript and Final Published Article that satisfies the requirements in the NIH Grants Policy Statement (GPS) regarding communicating and acknowledging federal funding (GPS 4.2.1 https://grants.nih.gov/​grants/​policy/​nihgps/​HTML5/​section_​4/​4.2.1_​acknowledgement_​of_​federal_​funding.htm                      and GPS 8.2.1                      https://grants.nih.gov/​grants/​policy/​nihgps/​HTML5/​section_​8/​8.2.1_​rights_​in_​data_​_​publication_​and_​copyrighting_​.htm ), as well as analogous requirements for acknowledging federal funding as incorporated into the terms of Other Transaction agreements and applicable contracts; and                
    - When an Author Accepted Manuscript is submitted to NIH, [1]                                           agreeing to a standard license that mirrors that of the Government Use License at  2 CFR 200.315  https://www.ecfr.gov/​current/​title-2/​subtitle-A/​chapter-II/​part-200/​subpart-D/​subject-group-ECFR8feb98c2e3e5ad2/​section-200.315,                      or its successor regulation, explicitly granting NIH the right to make the Author Accepted Manuscript publicly available through PubMed Central without embargo upon the Official Date of Publication.                

## 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, which includes making Author Accepted Manuscripts publicly available in PubMed Central upon the Official Date of Publication. A statement that conveys this point is incorporated into Notices of Award, the terms of Other Transaction agreements, and applicable contracts.
    - NIH encourages authors to include a statement that indicates the Author Accepted Manuscript is subject to the NIH Public Access Policy and that this means that NIH, as the funding agency, has the right to make the Author Accepted Manuscript publicly available in PubMed Central upon the Official Date of Publication. NIH provides sample language in the Guidance on Government Use License and Rights that authors may choose to include in Author Accepted Manuscripts. Such a statement ensures transparency and ensures awareness that NIH has the right to make the Author Accepted 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, and the rights that accrue to NIH upon the acceptance of funding are to the Author Accepted Manuscript. However, as noted in the section on Compliance and Enforcement, NIH will accept submission of the Final Published Article to PubMed Central from journals or publishers with formal agreements with NLM as compliant with the Policy when it may be made publicly available without embargo upon the Official Date of Publication.

## NIH Funding of Publication Costs

                    Reasonable costs associated with publication that are allowable costs of the project budget may be requested as direct or indirect costs, as specified in the GPS 7.9                     *https://grants.nih.gov/​grants/​policy/​nihgps/​html5/​section_​7/​7.9_​allowability_​of_​costs_​activities.htm*                     and as incorporated into the terms of Other Transaction agreements and applicable contracts (see the Guidance on Publication Costs for more information). Submission of Author Accepted 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 Author Accepted Manuscript to PubMed Central, such costs are not allowable.                

## Compliance and Enforcement

Regarding submission to PubMed Central, compliance with the Policy may be achieved through either:
    - Submission of the electronic version of the Author Accepted Manuscript 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 journals or publishers with formal agreements with NLM, upon the Official Date of Publication, for public availability without embargo.

Additional details on compliance and enforcement can be found below:
    -  Grants:                      Noncompliance 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 GPS 8.5, Specific Award Conditions and Remedies for Noncompliance (Specific Award Conditions and Enforcement Actions                      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 )). Non-competing continuation grant awards are subject to a delay in award processing for noncompliance with the NIH Public Access Policy.                
    -  Contracts:                      Compliance with and enforcement of the Policy will be consistent with the contract and the Federal Acquisition Regulations, as applicable.                
    -  Other Transaction Agreements:                      Compliance with and enforcement of the Policy will be consistent with applicable NIH policies and the terms of the agreement.                
    -  Intramural Research and the Official Work of NIH Employees:                      Compliance with and enforcement of the Policy will be consistent with applicable NIH policies and procedures.                

Communicating and acknowledging federal funding enables a clear, public-facing indication of NIH funding in Author Accepted Manuscripts and Final Published Articles. Failure to include required acknowledgments may result in noncompliance with the NIH Public Access Policy, in addition to resulting in noncompliance with terms and conditions of funding regarding communicating and acknowledging federal funding.

## 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.,*                     Author Accepted Manuscripts) under the Government Use License (2 CFR 200.315*https://www.ecfr.gov/​current/​title-2/​subtitle-A/​chapter-II/​part-200/​subpart-D/​subject-group-ECFR8feb98c2e3e5ad2/​section-200.315*), or its successor regulation, the National Institutes of Health (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 the terms of Other Transaction agreements and applicable contracts (                    *e.g.,*                     the rights in data clause within the contract).                

                    This Guidance assists authors in navigating compliance with the NIH Public Access Policy with minimal burden. NIH also encourages authors to be clear with journals and publishers to ensure journals and publishers understand that NIH has a right to make Author Accepted Manuscripts publicly available upon the Official Date of Publication.                          ( print page 102926)    

## Public Access Policy Requirements Related to Rights

Upon accepting NIH funding, recipients grant to NIH the right to make Author Accepted Manuscripts resulting 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, in the terms of Other Transaction agreements, and in applicable contracts.

Authors submitting Author Accepted Manuscripts to PubMed Central must agree to a submission statement as part of the standard PubMed Central manuscript submission process. Under the NIH Public Access Policy, authors submitting an Author Accepted Manuscript to PubMed Central must provide NIH with a standard license that mirrors the Government Use License. This language, included as part of this submission statement to PubMed Central, states:

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 make the final, peer-reviewed manuscript publicly available in PubMed Central upon the Official Date of Publication.

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

## Guidance for Communicating Rights in Author Accepted Manuscripts

                    NIH highly encourages authors to be transparent during the journal submission process by indicating to the journal or publisher that the Author Accepted Manuscript, should the Submitted Manuscript [2]                                          be accepted, is subject to the NIH Public Access Policy, and that this means that NIH, as the funding agency, has the right to make the Author Accepted 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.                

NIH suggests that authors include the points above as a statement in the Submitted Manuscript. Such a statement may accompany the required funding acknowledgment. NIH provides the following sample language that may be included in the Submitted Manuscript and then, should it be accepted, the Author Accepted Manuscript:

This manuscript is the result of funding in whole or in part by the National Institutes of Health (NIH). 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, as defined by NIH.

## Guidance on Publication Costs

## Purpose

                    The National Institutes of Health (NIH) reiterates that compliance with the Public Access Policy is free. However, NIH recognizes that some peer-reviewed publishing routes may result in publication costs, including, but not limited to, article processing charges (APCs). Publication costs are allowable when they comport with the existing NIH cost principles (Grants Policy Statement (GPS) 7.2                     *https://grants.nih.gov/​grants/​policy/​nihgps/​HTML5/​section_​7/​7.2_​the_​cost_​principles.htm*                     and GPS 7.9.1                     *https://grants.nih.gov/​grants/​policy/​nihgps/​html5/​section_​7/​7.9_​allowability_​of_​costs_​activities.htm#Selected*                     (Publication and Printing Costs). Cost principles clarify when costs should be allocated as direct versus indirect costs, and they clarify charges and fees that are allowable under the outlined conditions.                

This Guidance clarifies publication costs that are not allowable based on existing cost principles. It also outlines Points to Consider for Authors and Institutions in Assessing Reasonable Costs. This Guidance is intended to help funded authors and institutions understand what costs are allowable and reasonable under the NIH Public Access Policy. The NIH GPS also permits allowable and reasonable costs to be used to make public other works resulting from NIH funding that are not subject to the NIH Public Access Policy. This Guidance includes a brief section describing these kinds of works. The factors for what make costs unallowable are broadly applicable, regardless of whether the publication or other work is subject to the NIH Public Access Policy.

## Public Access Policy Requirements Related to Costs

                    All costs must comport with 2 CFR 200 subpart E*https://www.ecfr.gov/​current/​title-2/​subtitle-A/​chapter-II/​part-200/​subpart-E,*                     or its successor regulation, as implemented in NIH GPS 7.2 and GPS 7.9                     *https://grants.nih.gov/​grants/​policy/​nihgps/​HTML5/​section_​7/​7.9_​allowability_​of_​costs_​activities.htm*. These principles also apply as analogous requirements in the terms of Other Transaction agreements. For applicable contracts, all publication costs must comport with 2 CFR 200 subpart E, or its successor regulation, and the terms and conditions of the contract.                

The NIH 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 the terms of Other Transaction agreements and applicable contracts. Importantly, the NIH Public Access Policy also states that submission of Author Accepted Manuscripts to PubMed Central remains free for authors. Journal or publisher fees that arise during the course of the publication process for the sole purpose of submitting the Author Accepted Manuscript to PubMed Central are not allowable costs. Compliance with the Policy does not require the payment of an open access fee to a journal.

## Other Unallowable Costs

In addition to not allowing the payment of fees to submit Author Accepted Manuscripts to PubMed Central, examples of other unallowable costs are listed below in the context of the 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, publicly available product 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 all publication costs ( e.g.,                      an agreement the institution has with a publisher whereby all authors from that institution may 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                      https://grants.nih.gov/​grants/​policy/​nihgps/​HTML5/​section_​7/​7.4_​reimbursement_​of_​facilities_​and_​administrative_​costs.htm ). Note that institutions have discretion in apportioning publication costs among agreements and NIH funds, as long as when NIH funds are used, such costs are otherwise allowable and consistently charged, regardless of the source of funds, per institutional policy.                
    - Costs for publishing services that are charged differentially because an Author Accepted Manuscript is subject to the NIH Public Access Policy or the work is the result of NIH funding are unallowable because charges must be levied impartially on all items       ( print page 102927)                          published by the journal, whether or not under a federal award (GPS 7.9.1).                
    - Costs for services incurred after closeout of the award, even for an Author Accepted Manuscript subject to the NIH Public Access Policy, are unallowable because the costs of publications must be incurred before closeout (GPS 7.9.1). Note that this means that costs for publication may be charged after the period of performance and prior to closeout ( i.e.,                      during the 120-day liquidation period). However, these costs must only be for the originally approved activities and must not be associated with any new work performed outside of the period of performance.                

## 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, so NIH is instead providing these Points to Consider in assessing reasonable costs to guide authors and institutions. While NIH may modify this approach in the future, NIH encourages researchers and institutions to consider, when determining whether costs are reasonable:                
    - Amount of publication cost in relation to NIH award
    - Other works researchers may wish to produce during an award period
    - Professional and institutional priorities
    - Sustainability in terms of the library budget, laboratory budget, and other relevant budgets, if such costs were to be consistently paid
    - Relevance of the journal in communicating findings to advance science and/or improve health outcomes
    - Suitability of the journal's target readership for the dissemination of the content

## Other Public Works for Which Allowable Costs May Be Requested

This Guidance is primarily to help funded authors and institutions understand what costs are allowable under the NIH Public Access Policy. NIH acknowledges that the public dissemination of results from NIH funding does not occur only through peer-reviewed publications. Models for sharing research findings are evolving and allowable costs may be requested for publicly disseminating works reporting on the results of NIH funding that are not subject to the NIH Public Access Policy.

As a reminder, the unallowable costs listed above continue to apply, and works must be made publicly available to qualify for costs.

## Reputable Journals and Responsible Conduct of Research

                    In addition, NIH reiterates its Statement on Article Publication Resulting from NIH Funded Research                     *https://grants.nih.gov/​grants/​guide/​notice-files/​NOT-OD-18-011.html,*                     a 2017 NIH Guide Notice that encourages authors to publish papers resulting from NIH-funded research in reputable journals. Fees paid to journals that have characteristics described in the Statement may be considered unreasonable.                

                    Finally, NIH also reiterates the importance of maintaining integrity in science in its Guidance on the requirement for Instruction in the Responsible Conduct of Research                     *https://grants.nih.gov/​grants/​guide/​notice-files/​NOT-OD-22-055.html,*                     which includes responsible authorship and publication.                

Dated: December 12, 2024.

Lawrence A. Tabak,

Principal Deputy Director, National Institutes of Health.

# Footnotes

1.                             This happens typically through the NIH Manuscript Submission (NIHMS) System.                    
        Back to Citation      

2.                             The author's pre-accepted version of the manuscript that is submitted to a journal or publisher.                    
        Back to Citation      

[FR Doc. 2024-29929 Filed 12-17-24; 8:45 am]

BILLING CODE 4140-01-P