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[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102919-102927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29929]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

The National Institutes of Health Public Access Policy

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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 [email protected].

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[supreg] 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

[[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

[[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

[[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

[[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

[[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;

[[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.
---------------------------------------------------------------------------

    \1\ This happens typically through the NIH Manuscript Submission 
(NIHMS) System.
---------------------------------------------------------------------------

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.

[[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.
---------------------------------------------------------------------------

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

    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

[[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.
[FR Doc. 2024-29929 Filed 12-17-24; 8:45 am]
BILLING CODE 4140-01-P
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